Note: Descriptions are shown in the official language in which they were submitted.
TITLE
COMPRESSIBLE STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS
CROSS REFERENCE TO RELATED APPLICATION
This non-provisional patent application is a continuation-in-part application
under 35
U.S.C. 120 of U.S. Patent Application Ser. No. 12/894,383, entitled
"Implantable Fastener
Cartridge Comprising Bioabsorbable Layers", filed on September 30, 2010.
BACKGROUND
[0001] The present invention relates to surgical instruments and, in various
embodiments, to
surgical cutting and stapling instruments and staple cartridges therefor that
are designed to cut
and staple tissue.
SUMMARY
[0001a] In one aspect, there is provided a staple cartridge for use with a
surgical stapler, the
staple cartridge comprising: a cartridge body, comprising a deck; and a
plurality of staple
cavities defined within the deck, wherein each the staple cavity comprises an
opening in the
deck; an implantable compressible portion positioned above the deck; a
plurality of staples,
wherein at least a portion of each staple is removably stored within one of
the plurality of staple
cavities, wherein each staple is movable between an unfired position and a
fired position,
wherein each staple extends above the deck and is at least partially
positioned within the
compressible portion when each staple is positioned in the unfired position,
wherein each staple
is deformable between an unfired configuration and a fired configuration when
each staple is
moved between the unfired position and the fired position, and wherein the
compressible portion
is captured within the staples and assume different compressed heights within
different the
staples when the staples are deformed between the unfired configuration and
the fired
configuration; and an array of retainers positioned above the implantable
compressible portion,
wherein each retainer comprises a staple guide, and wherein at least a portion
of each staple is
positioned within the staple guide when the staple is in the unfired position.
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[0001131 In one aspect, there is provided a staple cartridge for use with a
surgical stapler, the
staple cartridge comprising: a cartridge body, comprising: a deck; and a
plurality of staple
cavities defined within the deck, wherein each staple cavity comprises an
opening in the deck; an
implantable compressible portion, wherein the deck is positioned relative to a
first side of the
implantable compressible portion; a plurality of staples, wherein at least a
portion of each staple
is removably stored within one of the plurality of staple cavities, wherein
each staple is movable
between an unfired position and a fired position, wherein each staple extends
above the deck and
is at least partially positioned within the compressible portion when each
staple is positioned in
the unfired position, wherein each staple is deformable between an unfired
configuration and a
fired configuration when each staple is moved between the unfired position and
the fired
position, and wherein the compressible portion is captured within the staples
and assume
different compressed heights within different staples when the staples are
deformed between the
unfired configuration and the fired configuration; and an array of formed
features positioned
relative to a second side of the implantable compressible portion, wherein
each formed feature
comprises a staple guide for receiving at least a portion of the staple.
10001e] In one aspect, there is provided a staple cartridge for use with a
surgical stapler, the
staple cartridge comprising a cartridge body, comprising: a deck; and a
plurality of staple
cavities defined within the deck, wherein each staple cavity comprises an
opening in the deck; an
implantable compressible portion, wherein the deck is positioned relative to a
first side of the
implantable compressible portion; a plurality of staples, wherein at least a
portion of each staple
is removably stored within one of the plurality of staple cavities, wherein
each staple is movable
between an unfired position and a fired position, wherein each staple extends
above the deck and
is at least partially positioncd within the compressible portion when each
staple is positioned in
the unfired position, wherein each staple is deformable between an unfired
configuration and a
fired configuration when each staple is moved between the unfired position and
the fired
position, and wherein the compressible portion is captured within the staples
and assume
different compressed heights within different the staples when the staples are
deformed between
the unfired configuration and the fired configuration; and retaining means for
receiving at least a
portion of the staples when in the unfired position for retaining at least a
portion of the staples in
their unfired position prior to being deployed from their unfired position to
their fired position,
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wherein the implantable compressible portion is positioned intermediate the
retaining means and
the deck.
BRIEF DESCRIPTION OF THE DRAWINGS
[00021 The features and advantages of this invention, and the manner of
attaining them, will
become more apparent and the invention itself will be better understood by
reference to the
following description of embodiments of the invention taken in conjunction
with the
accompanying drawings, wherein:
[00031 FIG. 1 is a cross-sectional view of a surgical instrument embodiment;
100041 FIG. IA is a perspective view of one embodiment of an implantable
staple cartridge;
[0005] FIGS. 1B-1E illustrate portions of an end effector clamping and
stapling tissue with an
implantable staple cartridge;
100061 FIG. 2 is a partial cross-sectional side view of another end effector
coupled to a portion
of a surgical instrument with the end effector supporting a surgical staple
cartridge and with the
anvil thereof in an open position;
[00071 FIG. 3 is another partial cross-sectional side view of the end effector
of FIG. 2 in a
closed position;
[00081 FIG. 4 is another partial cross-sectional side view of the end effector
of FIGS. 2 and 3
as the knife bar is starting to advance through the end effector;
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[0009] FIG. 5 is another partial cross-sectional side view of the end effector
of FIGS. 2-4 with
the knife bar partially advanced therethrough;
[0010] FIG. 6 is a perspective view of an alternative staple cartridge
embodiment installed in a
surgical cutting and stapling device;
[0011] FIG. 7 is a top view of the surgical staple cartridge and elongated
channel of the device
depicted in FIG. 6;
[0012] FIG. 8 is a top view of another surgical staple cartridge embodiment
installed in an
elongated channel of an end effector;
[0013] FIG. 9 is a bottom view of an anvil;
[0014] FIG. 10 is a partial perspective view of a plurality of staples forming
a portion of a
staple line;
[0015] FIG. 11 is another partial perspective view of the staple line of FIG.
10 with the staples
thereof after being formed by being contacted by the anvil of the surgical
cutting and stapling
device;
[0016] FIG. 12 is a partial perspective view of alternative staples forming a
portion of another
staple line;
[0017] FIG 13 is a partial perspective view of alternative staples forming a
portion of another
staple line;
[0018] FIG. 14 is a partial perspective view of alternative staples forming a
portion of another
staple line embodiment;
[0019] FIG. 15 is a cross-sectional view of an end effector supporting a
staple cartridge;
[0020] FIG. 16 is a cross-sectional view of the elongated channel portion of
the end effector of
FIG. 15 after the implantable staple cartridge body portion and staples have
been removed
therefrom;
[0021] FIG. 17 is a cross-sectional view of an end effector supporting another
staple cartridge;
[0022] FIGS. 18A-18D diagram the deformation of a surgical staple positioned
within a
collapsible staple cartridge body in accordance with at least one embodiment;
[0023] FIG. 19A is a diagram illustrating a staple positioned in a crushable
staple cartridge
body;
[0024] FIG. 19B is a diagram illustrating the crushable staple cartridge body
of FIG. 19A being
crushed by an anvil;
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[0025] FIG. 19C is a diagram illustrating the crushable staple cartridge body
of FIG. 19A being
further crushed by the anvil;
[0026] FIG. 19D is a diagram illustrating the staple of FIG. 19A in a fully
formed
configuration and the crushable staple cartridge of FIG. 19A in a fully
crushed condition;
[0027] FIG. 20 is a diagram depicting a staple positioned against a staple
cartridge support
surface and illustrating potential relative movement therebetween;
[0028] FIG. 21 is a cross-sectional view of a staple cartridge support surface
comprising a slot,
or trough, configured to stabilize the base of the staple of FIG 20;
[0029] FIG. 22 is a cross-sectional view of a staple comprising an overmolded
crown and a
slot, or trough, configured to receive a portion of the crown in accordance
with at least one
alternative embodiment;
[0030] FIG. 23 is a top view of a staple cartridge in accordance with at least
one embodiment
comprising staples embedded in a collapsible staple cartridge body;
[0031] FIG. 24 is an elevational view of the staple cartridge of FIG. 23;
[0032] FIG. 25 is an elevational view of a staple cartridge in accordance with
at least one
embodiment comprising a protective layer surrounding staples positioned within
a collapsible
staple cartridge body;
[0033] FIG. 26 is a cross-sectional view of the staple cartridge of FIG. 25
taken along line 26-
26 in FIG. 25;
[0034] FIG. 27 is an elevational view of a staple cartridge in accordance with
at least one
embodiment comprising staples at least partially extending outside of a
collapsible staple
cartridge body and a protective layer surrounding the staple cartridge body;
[0035] FIG. 28 is a cross-sectional view of the staple cartridge of FIG. 27
taken along line 28-
28 in FIG. 27;
[0036] FIG. 29 is a partial break-away view of a staple cartridge in
accordance with at least
one embodiment comprising staples at least partially embedded in a collapsible
staple cartridge
body, the staples being at least partially positioned in a staple cavity void
in the staple cartridge
body;
[0037] FIG. 30 is a cross-sectional view of the staple cartridge of FIG. 29
taken along line 30-
30 in FIG. 29;
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[0038] FIG. 31 is a partial break-away view of a staple cartridge in
accordance with at least
one embodiment;
[0039] FIG. 32 is a partial break-away view of a staple cartridge in
accordance with at least
one embodiment comprising staples at least partially embedded within a
collapsible staple
cartridge body and an alignment matrix connecting the staples and aligning the
staples with
respect to each other;
[0040] FIG. 33 is a cross-sectional view of the staple cartridge of FIG. 32
taken along line 33-
33 in FIG. 32;
[0041] FIG. 34 is partial cut-away view of an inner layer of a compressible
staple cartridge
body;
[0042] FIG. 35 is a diagram illustrating the inner layer of FIG. 34 compressed
between a
transfer plate and a support plate;
[0043] FIG. 36 is a diagram illustrating staples being inserted into the
compressed inner layer
of FIG. 35;
[0044] FIG. 37 is a diagram of the support plate of FIG. 35 being removed away
from the inner
layer;
[0045] FIG. 38 is a diagram of a subassembly comprising the inner layer of
FIG. 34 and the
staples of FIG. 36 being inserted into an outer layer;
[0046] FIG. 39 is a diagram illustrating the outer layer of FIG. 38 being
sealed to form a sealed
staple cartridge;
[0047] FIG. 40 is a cross-sectional view of the sealed staple cartridge of
FIG. 39;
[0048] FIG. 41 is a cross-sectional view of a staple cartridge and staple
cartridge channel in
accordance with at least one embodiment;
[0049] FIG. 42 is a diagram illustrating a portion of the staple cartridge of
FIG. 41 in a
deformed state;
[0050] FIG. 43 is an elevational view of an end effector of a surgical stapler
comprising an
anvil in an open position and a staple cartridge positioned within a staple
cartridge channel;
[0051] FIG. 44 is an elevational view of the end effector of FIG. 43
illustrating the anvil in a
closed position and the staple cartridge compressed between the anvil and the
staple cartridge
channel;
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[0052] FIG. 45 is an elevational view of the end effector of FIG. 43
illustrating the staple
cartridge of FIG. 43 positioned within the staple cartridge channel in an
alternative manner;
[0053] FIG. 46 is a cross-sectional view of an end effector of a surgical
stapler comprising a
compressible staple cartridge positioned within a staple cartridge channel and
a piece of buttress
material attached to an anvil;
[0054] FIG. 47 is a cross-sectional view of the end effector of FIG. 46
illustrating the anvil in a
closed position;
[0055] FIG. 48 is a cross-sectional view of an alternative embodiment of an
end effector of a
surgical stapler comprising a staple cartridge comprising a water impermeable
layer;
[0056] FIG. 49 is a cross-sectional view of another alternative embodiment of
an end effector
of a surgical stapler;
[0057] FIG. 50 is a cross-sectional view of an alternative embodiment of an
end effector of a
surgical stapler comprising a stepped anvil and a staple cartridge comprising
a stepped cartridge
body;
[0058] FIG. 51 is a cross-sectional view of another alternative embodiment of
an end effector
of a surgical stapler;
[0059] FIG. 52 is a cross-sectional view of an alternative embodiment of an
end effector of a
surgical stapler comprising inclined tissue-contacting surfaces;
[0060] FIG. 53 is a cross-sectional view of another alternative embodiment of
an end effector
of a surgical stapler comprising inclined tissue-contacting surfaces;
[0061] FIG. 54 is a cross-sectional view of an alternative embodiment of an
end effector of a
surgical stapler comprising a support insert configured to support a staple
cartridge;
[0062] FIG. 55 is a cross-sectional view of an alternative embodiment of an
end effector of a
surgical stapler comprising a staple cartridge comprising a plurality of
compressible layers;
[0063] FIG. 56 is a cross-sectional view of an alternative embodiment of an
end effector of a
surgical stapler comprising a staple cartridge comprising a stepped
compressible cartridge body;
[0064] FIG. 57 is a cross-sectional view of another alternative embodiment of
an end effector
of a surgical stapler comprising a staple cartridge comprising a stepped
compressible cartridge
body;
[0065] FIG. 58 is a cross-sectional view of an alternative embodiment of an
end effector of a
surgical stapler comprising a staple cartridge comprising a curved tissue-
contacting surface;
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[0066] FIG. 59 is a cross-sectional view of an alternative embodiment of an
end effector of a
surgical stapler comprising a staple cartridge having an inclined tissue-
contacting surface;
[0067] FIG. 60 is a cross-sectional view of a compressible staple cartridge
comprising staples
and at least one medicament stored therein;
[0068] FIG. 61 is a diagram illustrating the compressible staple cartridge of
FIG. 60 after it has
been compressed and the staples contained therein have been deformed;
[0069] FIG. 62 is a partial cut-away view of a staple cartridge in accordance
with at least one
embodiment;
[0070] FIG. 63 is a cross-sectional view of the staple cartridge of FIG. 62;
[0071] FIG. 64 is a perspective view of an implanted staple cartridge in
accordance with at
least one alternative embodiment;
[0072] FIG. 65 is a cross-sectional view of the implanted staple cartridge of
FIG. 64;
[0073] FIG. 66 is a perspective view of an alternative embodiment of a staple
cartridge
comprising deformable members extending from an outer layer of the staple
cartridge;
[0074] FIG. 67 is a perspective view of an alternative embodiment of a staple
cartridge
comprising an outer layer of the staple cartridge being assembled to an inner
layer;
[0075] FIG. 68 is a cross-sectional view of an alternative embodiment of a
staple cartridge
comprising a plurality of staples, a compressible layer, and a pledget layer;
[0076] FIG. 69 is a perspective view of the pledget layer of FIG. 68;
[0077] FIG. 70 is a perspective view of a pledget singulated from the pledget
layer of FIG. 68
and a staple aligned with a groove in the pledget;
[0078] FIG. 71 is a perspective view of two connected pledgets from the
pledget layer of FIG.
68;
[0079] FIG. 72 is a perspective view of a pledget support frame of the pledget
layer of FIG. 68
being removed from the singulated pledgets;
[0080] FIG. 73 is an exploded perspective view of an alternative embodiment of
a
compressible staple cartridge comprising staples therein and a system for
driving the staples
against an anvil;
[0081] FIG. 73A is a partial cut-away view of an alternative embodiment of the
staple cartridge
of FIG. 73;
[0082] FIG. 74 is a cross-sectional view of the staple cartridge of FIG. 73;
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[0083] FIG. 75 is an elevational view of a sled configured to traverse the
staple cartridge of
FIG. 73 and move the staples to toward the anvil;
[0084] FIG. 76 is a diagram of a staple driver which can be lifted toward the
anvil by the sled
of FIG. 75;
[0085] FIG. 77 is a break-away view of a staple cartridge in accordance with
at least one
alternative embodiment comprising staples positioned within staple drivers;
[0086] FIG. 78 is a cross-sectional view of the staple cartridge of FIG. 77
positioned within a
staple cartridge channel;
[0087] FIG. 79 is a cross-sectional view of the staple cartridge of FIG. 77
illustrating an anvil
moved into a closed position and staples contained within the staple cartridge
deformed by the
anvil;
[0088] FIG. 80 is a cross-sectional view of the staple cartridge of FIG. 77
illustrating the
staples moved upwardly toward the anvil;
[0089] FIG. 81 is a perspective view of an alternative embodiment of a staple
cartridge
comprising straps connecting the flexible sides of the staple cartridge;
[0090] FIG. 82 is a perspective view of a sled and cutting member assembly;
[0091] FIG. 83 is a diagram of the sled and cutting member assembly of FIG. 82
being used to
lift the staples of the staple cartridge of FIG. 77;
[0092] FIG. 84 is a diagram illustrating a sled configured to engage and lift
staples toward an
anvil and a lock-out system configured to selectively permit the sled to move
distally;
[0093] FIGS. 85A-85C illustrate the progression of a staple being inserted
into a staple crown;
[0094] FIG. 86 is a cross-sectional view of a staple cartridge comprising a
support pan or
retainer;
[0095] FIG. 87 is a partial cross-sectional view of a compressible staple
cartridge in
accordance with at least one alternative embodiment;
[0096] FIG. 88 is a diagram illustrating the staple cartridge of FIG. 87 in an
implanted
condition;
[0097] FIG. 89 is a partial cut-away view of a compressible staple cartridge
in accordance with
at least one alternative embodiment;
[0098] FIG. 90 is a partial cross-sectional view of the staple cartridge of
FIG. 89;
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[0099] FIG. 91 is a diagram illustrating the staple cartridge of FIG. 89 in an
implanted
condition;
[0100] FIG. 92 is a partial cross-sectional view of a crushable staple
cartridge in accordance
with at least one alternative embodiment;
[0101] FIG. 93 is a partial cut-away view of a collapsible staple cartridge in
accordance with at
least one embodiment comprising a plurality of collapsible elements;
[0102] FIG. 94 is a perspective view of a collapsible element of FIG. 93 in an
uneollapsed
state;
[0103] FIG. 95 is a perspective view of the collapsible element of FIG. 94 in
a collapsed state;
[0104] FIG. 96A is a partial cross-sectional view of an end effector of a
surgical stapling
instrument comprising a jaw, a staple cartridge channel positioned opposite
the jaw, and a staple
cartridge positioned within the staple cartridge channel, wherein the jaw
comprises a retention
matrix attached thereto;
[0105] FIG. 96B is a partial cross-sectional view of the end effector of FIG.
96A illustrating
the jaw being moved toward the staple cartridge channel, the staple cartridge
being compressed
by the anvil and the retention matrix, and a staple at least partially
extending through tissue
positioned intermediate the retention matrix and the staple cartridge;
[0106] FIG. 96C is a partial cross-sectional view of the end effector of FIG.
96A illustrating
the jaw in a final position and the retention matrix engaged with the staple
of FIG. 96B;
[0107] FIG. 96D is a partial cross-sectional view of the end effector of FIG.
96A illustrating
the jaw and the staple cartridge channel being moved away from the implanted
staple cartridge
and retention matrix;
[0108] FIG. 97 is a perspective view of a retention aperture of a retention
matrix in accordance
with at least one alternative embodiment comprising a plurality of retention
members configured
to engage a fastener leg extending therethrough;
[0109] FIG. 98 is a perspective view of a retention aperture of a retention
matrix in accordance
with at least one alternative embodiment comprising six retention members;
[0110] FIG. 99 is a perspective view of a retention aperture of a retention
matrix in accordance
with at least one alternative embodiment comprising eight retention members;
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[0111] FIG. 100 is a perspective view of a retention aperture of a retention
matrix in
accordance with at least one alternative embodiment comprising a plurality of
retention members
configured to engage a fastener leg extending therethrough;
[0112] FIG. 101 is a perspective view of a retention aperture of a retention
matrix in
accordance with at least one alternative embodiment comprising six retention
members;
[0113] FIG. 102 is a perspective view of a retention aperture of a retention
matrix in
accordance with at least one alternative embodiment comprising eight retention
members;
[0114] FIG. 103 is a perspective view of a retention aperture of a retention
matrix in
accordance with at least one alternative embodiment comprising a plurality of
retention members
that have been stamped from a sheet of metal;
[0115] FIG. 104 is a perspective view of a retention aperture of a retention
matrix in
accordance with at least one alternative embodiment comprising a plurality of
apertures
extending around the perimeter of the retention aperture;
[0116] FIG. 105 is a top view of a retention aperture of a retention matrix in
accordance with at
least one alternative embodiment;
[0117] FIG. 106 is a top view of a retention aperture of a retention matrix in
accordance with at
least one alternative embodiment;
[0118] FIG. 107 is a top view of a retention aperture of a retention matrix in
accordance with at
least one alternative embodiment;
[0119] FIG. 108 is a top view of a retention aperture of a retention matrix in
accordance with at
least one alternative embodiment;
[0120] FIG. 109 is a top view of a retention aperture of a retention matrix in
accordance with at
least one alternative embodiment;
[0121] FIG. 110 is a top view of a retention aperture of a retention matrix
comprising a
retention tab extending into the retention aperture in accordance with at
least one embodiment;
[0122] FIG. 111 is a top view of a retention aperture of a retention matrix
comprising a
retention tab extending into the retention aperture in accordance with at
least one alternative
embodiment;
[0123] FIG. 112 is a perspective view of a fastening system comprising a
plurality of staples, a
retention matrix engaged with the staples, and an alignment matrix configured
to align the
staples;
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[0124] FIG. 113 is a perspective view of the retention matrix of FIG. 112;
[0125] FIG. 114 is a perspective view of the alignment matrix of FIG. 112;
[0126] FIG. 115 is a partial top view of the retention matrix of FIG. 112
engaged with the
staples of FIG. 112;
[0127] FIG. 116 is a partial bottom view of the retention matrix of FIG. 112
engaged with the
staples of FIG. 112;
[0128] FIG. 117 is a partial elevational view of the fastening system of FIG.
112;
[0129] FIG. 118 is a partial perspective view of the fastening system of FIG.
112;
[0130] FIG. 119 is a partial cross-sectional view of the retention matrix of
FIG. 112 engaged
with the staples of FIG. 112;
[0131] FIG. 120 is a partial cross-sectional view of the fastening system of
FIG. 112;
[0132] FIG. 121 is a perspective view of the fastening system of FIG. 112
further comprising
protective caps assembled to the legs of the staples;
[0133] FIG. 122 is a bottom perspective view of the fastening system
arrangement of FIG. 121;
[0134] FIG. 123 is a partial perspective view of the fastening system
arrangement of FIG. 121;
[0135] FIG. 124 is a partial cross-sectional view of the fastening system
arrangement of FIG.
121;
[0136] FIG. 125 is an elevational view of an end effector in accordance with
at least one
embodiment comprising a jaw in an open position, a retention matrix and a
plurality of protective
caps positioned in the jaw, and a staple cartridge positioned in a staple
cartridge channel;
[0137] FIG. 126 is an elevational view of the end effector of FIG. 125 in a
closed position;
[0138] FIG. 127 is an elevational view of the end effector of FIG. 125 in a
fired position;
[0139] FIG. 128 is an elevational view of the retention matrix and protective
caps of FIG. 125
assembled to the staple cartridge of FIG. 125;
[0140] FIG. 129 is a detail view of the arrangement of FIG. 128;
[0141] FIG. 130 is an elevational view of the end effector of FIG. 125
illustrating the jaw in an
open position with thinner tissue positioned between the retention matrix and
the staple
cartridge;
[0142] FIG. 131 is an elevational view of the end effector of FIG. 125
illustrating the jaw in a
closed position against the thinner tissue of FIG. 130;
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[0143] FIG. 132 is an elevational view of the end effector of FIG. 125
illustrating the jaw in a
fired position to capture the thinner tissue of FIG. 130 between the retention
matrix and the
staple cartridge;
[0144] FIG. 133 is an elevational view of the retention matrix and the
protective caps of FIG.
125 assembled to the staple cartridge of FIG. 125 with the thin tissue of FIG.
130 positioned
therebetween;
[0145] FIG. 134 is a detail view of the arrangement of FIG. 133;
[0146] FIG. 135 is a cross-sectional view of a protective cap positioned on
the tip of a staple
leg in accordance with at least one alternative embodiment;
[0147] FIG. 136 is a perspective view of a plurality of protective caps
embedded within a sheet
of material;
[0148] FIG. 137 is a perspective view of a jaw comprising a plurality of
recesses configured to
receive a plurality of protective caps therein;
[0149] FIG. 138 is a detail view of a portion of a jaw comprising a sheet
covering the
protective caps positioned within the jaw of FIG. 137;
[0150] FIG. 139 is a cross-sectional view of a protective cap positioned on a
tip of a staple leg
in accordance with at least one alternative embodiment wherein the protective
cap comprises an
interior forming surface;
[0151] FIG. 140 is another cross-sectional view of the protective cap of FIG.
139 illustrating
the staple leg being deformed against the forming surface;
[0152] FIG. 141 is a top view of an alternative embodiment of a retention
matrix comprising a
plurality of connected matrix elements;
[0153] FIG. 142 is a top view of an alternative embodiment of a retention
matrix comprising a
plurality of connected matrix elements;
[0154] FIG. 143 is a top view of an alternative embodiment of a retention
matrix comprising a
plurality of connected matrix elements;
[0155] FIG. 144 is a top view of an alternative embodiment of an array of
retention matrices
comprising a plurality of connected matrix elements;
[0156] FIG. 145 is a top view of an alternative embodiment of a retention
matrix comprising a
plurality of connected matrix elements;
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[0157] FIG. 146 is a partial exploded view of a jaw comprising a retention
matrix including a
compressible cover;
[0158] FIG. 147 is a detail view of the retention matrix of FIG. 146;
[0159] FIG. 148 is a partial cross-sectional view of a fastening system
comprising a retention
matrix including a compressible layer and a plurality of cells encapsulating
one or more
medicaments;
[0160] FIG. 149 is a diagram illustrating staple legs which have pierced the
cells of FIG. 148
as they are being engaged with the retention matrix;
[0161] FIG. 150 is a partial cross-sectional view of a fastening system
comprising a retention
matrix including a compressible layer;
[0162] FIG. 151 is an elevational view of a fastener cartridge insertion
assembly comprising a
holder, a first fastener cartridge, and a second fastener cartridge;
[0163] FIG. 152 is an elevational view of an end effector of a surgical
stapler comprising a first
jaw and a second jaw, the second jaw being illustrated in an open
configuration;
[0164] FIG. 153 is an elevational view of the end effector of FIG. 152
illustrating the second
jaw in a closed configuration and the fastener cartridge insertion assembly of
FIG. 151 being
used to load the first jaw with the first cartridge and the second jaw with
the second cartridge;
[0165] FIG. 154 is an elevational view of the loaded end effector of FIG. 153
illustrating the
cartridge insertion assembly removed from the end effector, the second jaw in
an open
configuration once again, and tissue positioned intermediate the first jaw and
the second jaw;
[0166] FIG. 155 is an elevational view of the loaded end effector of FIG. 154
in a fired
configuration;
[0167] FIG. 156 is an elevational view of the first cartridge and the second
cartridge in an
implanted condition;
[0168] FIG. 157 is an elevational view of the end effector of FIG. 152
illustrating a portion of
the first cartridge still engaged with the first jaw in accordance with at
least one embodiment;
[0169] FIG. 158 is an elevational view of an alternative embodiment of a
fastener cartridge
insertion assembly comprising a holder, a first fastener cartridge, and a
second fastener cartridge;
[0170] FIG. 159 is an elevational view of the fastener cartridge insertion
assembly of FIG. 158
being used to load a first jaw of an end effector with the first cartridge and
a second jaw with the
second cartridge;
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[0171] FIG. 160 is a cross-sectional view of the loaded end effector of FIG.
159;
[0172] FIG. 161 is a perspective view of a surgical stapler comprising a
bottom jaw and a top
jaw in accordance with at least one embodiment illustrated with portions of
the surgical stapler
removed;
[0173] FIG. 162 is a perspective view of the surgical stapler of FIG. 161 with
the top jaw
removed;
[0174] FIG. 163 is a perspective view of a slidable anvil system of the top
jaw of the surgical
stapler of FIG. 161 comprising a first slidable anvil and a second slidable
anvil;
[0175] FIG. 164 is an end view of the slidable anvil system of FIG. 163;
[0176] FIG. 165 is a top view of the slidable anvil system of FIG. 163;
[0177] FIG. 166 is a diagram illustrating the slidable anvil system of FIG.
163 in an unfired
condition;
[0178] FIG. 167 is a diagram illustrating the first slidable anvil of the
slidable anvil system of
FIG. 163 in an unfired position and staples positioned within the bottom jaw
in an undeployed
position;
[0179] FIG. 168 is a diagram illustrating the staples in the bottom jaw in a
deployed
configuration and the first slidable anvil of FIG. 167 being pulled proximally
to deform a first
group of staple legs of the staples;
[0180] FIG. 169 is a diagram illustrating the first group of staples of FIG.
168 deformed to a
fully deformed state;
[0181] FIG. 170 is a diagram illustrating the second slidable anvil of the
slidable anvil system
of FIG. 163 being pushed distally to deform a second group of staple legs;
[0182] FIG. 171 is a partial perspective view of an anvil comprising a
plurality of forming
pockets in at least one embodiment;
[0183] FIG. 172 is a cross-sectional end view of the anvil of FIG. 171;
[0184] FIG. 173 is a diagram illustrating a first step in manufacturing the
forming pockets of
FIG. 171;
[0185] FIG. 174 is a diagram illustrating a second step in manufacturing the
forming pockets
of FIG. 171;
[0186] FIG. 175 is a top view of the forming pocket arrangement of the anvil
of FIG. 171;
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[0187] FIG. 176 is a diagram illustrating a first step of a manufacturing
process for producing
an anvil;
[0188] FIG. 177 is a diagram illustrating a second step in the manufacturing
process of FIG.
176;
[0189] FIG. 178 is a diagram illustrating a third step in the manufacturing
process of FIG. 176;
[0190] FIG. 179 is a left front perspective view of a surgical stapling and
severing instrument
with a handle portion including a link triggered automatic retraction and a
ratcheting manual
retraction mechanism;
[0191] FIG. 180 is a right aft perspective view of the surgical stapling and
severing instrument
of FIG. 179 with a portion of an elongate shaft cut away and a right half
shell of a handle
housing removed to expose an automatic end-of-firing travel retraction
mechanism and a manual
firing retraction mechanism;
[0192] FIG. 181 is a right aft perspective disassembled view of the handle
portion and an
elongate shaft of the surgical stapling and severing instrument of FIG. 179;
[0193] FIG. 182 is a right aft perspective view of the surgical stapling and
severing instrument
of FIG. 31 with a right half shell and outer portions of the implement portion
removed to expose
the closure and firing mechanisms in an initial state;
[0194] FIG. 183 is a right side view in elevation of the partially
disassembled surgical stapling
and severing instrument of FIG. 182;
[0195] FIG. 184 is a right aft perspective view of the partially disassembled
surgical stapling
and severing instrument of FIG. 182 with a closure mechanism closed and
clamped and the side
pawl firing mechanism completing a first stroke and with a manual retraction
mechanism
removed to expose a distal link of the linked rack that triggers automatic
retraction of the firing
mechanism;
[0196] FIG. 185 is a right aft perspective view of the partially disassembled
surgical stapling
and severing instrument of FIG. 183 with the side pawl firing mechanism
disengaged and the
distal link approaching automatic retraction;
[0197] FIG. 186 is left side view in elevation of the partially disassembled
surgical stapling
and severing instrument of FIG. 183 in an initial state of end effector open
and anti-backup
mechanism engaged;
[0198] FIG. 187 is a left side detail view of the right half shell and an anti-
backup release lever
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of the handle portion of FIG. 186;
[0199] FIG. 188 is a left side detail view in elevation of the disassembled
surgical stapling and
severing instrument of FIG. 179 with the closure trigger clamped, the firing
trigger performing a
final stroke and the distal link positioned to trip automatic retraction;
[0200] FIG. 189 is a left side detail in elevation of the disassembled
surgical stapling and
severing instrument of FIG. 188 immediately after the distal link has actuated
and locked
forward the anti-backup release lever, allowing the linked rack to retract;
[0201] FIG. 190 is a right disassembled perspective view of the idler and aft
gears and manual
retraction lever and ratcheting pawl of a manual retraction mechanism of the
surgical stapling
and severing instrument of FIG. 179;
[0202] FIG. 191 is a right perspective view of the manual retraction mechanism
of FIG. 190
with the manual retraction lever partially cut away to expose a smaller
diameter ratchet gear on
the aft gear engaging the ratcheting pawl;
[0203] FIG. 192 is a partially disassembled left side view in elevation of a
surgical stapling and
severing instrument of FIG. 179 with the anti-backup mechanism engaged to a
fully fired linked
rack that is disconnected from a combination tension/compression spring prior
to actuation of the
manual retraction lever of FIG. 190;
[0204] FIG. 193 is a partially disassembled left side view in elevation of the
surgical stapling
and severing instrument of FIG. 192 with hidden portions of the anti-backup
release lever, aft
gear, and manual firing release lever shown in phantom;
[0205] FIG. 194 is a partially disassembled left side view in elevation of the
surgical stapling
and severing instrument of FIG. 193 after actuation of the manual firing
release lever has
manually retracted the link rack;
[0206] FIG. 195 is a partially disassembled left side view in elevation of the
surgical stapling
and severing instrument of FIG. 194 with the linked rack omitted depicting the
manual firing
release lever disengaging the anti-backup mechanism;
[0207] FIG. 196 is a left side detail view of an alternative anti-backup
release lever and handle
housing for the surgical stapling and severing instrument of FIG. 179;
[0208] FIG. 197 is a left perspective disassembled view of the alternative
anti-backup release
lever, aft gear axle, and automatic retraction cam wheel of FIG. 196;
[0209] FIG. 198 is a right side view in elevation of the alternative anti-
backup release
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mechanism of FIG. 196 with the linked rack in a retracted position and the
anti-backup release
lever proximally positioned with the anti-backup plate engaged to the firing
rod;
[0210] FIG. 198A is a right detail side view in elevation of the aft gear,
automatic retraction
cam wheel and distal-most link of FIG. 198;
[0211] FIG. 199 is a right side view in elevation of the anti-backup release
mechanism of FIG.
198 after a first firing stroke;
[0212] FIG. 199A is a right detail side view in elevation of the aft gear,
automatic retraction
cam wheel and a second link of FIG. 199;
[0213] FIG. 200 is a right side view in elevation of the anti-backup release
mechanism of FIG.
199 after a second firing stroke;
[0214] FIG. 200A is a right detail side view in elevation of the aft gear,
automatic retraction
cam wheel and third link of FIG. 200;
[0215] FIG. 201 is a right detail side view in elevation of the anti-backup
release mechanism of
FIG. 200 after a third firing and final stroke;
[0216] FIG. 201A is a right detail side view in elevation of the aft gear,
automatic retraction
cam wheel and proximal-most fourth link of FIG. 201;
[0217] FIG. 202 is a right side view in elevation of the automatic release
mechanism of FIG.
201 after a further firing stroke causes the automatic retraction cam wheel to
distally slide and
lock the anti-backup release lever, disengaging the anti-backup mechanism;
[0218] FIG. 203 is a left, front perspective view of an open staple applying
assembly with a
right half portion of a replaceable staple cartridge included in a staple
channel;
[0219] FIG. 204 is an exploded perspective view of the staple applying
assembly of FIG. 203
with a complete replaceable staple cartridge and an nonarticulating shaft
configuration;
[0220] FIG. 205 is a perspective view of a two-piece knife and firing bar ("E-
beam") of the
staple applying assembly of FIG. 203;
[0221] FIG. 206 is a perspective view of a wedge sled of a staple cartridge of
a staple applying
assembly;
[0222] FIG. 207 is a left side view in elevation taken in longitudinal cross
section along a
centerline line 207-207 of the staple applying assembly of FIG. 203;
[0223] FIG. 208 is a perspective view of the open staple applying assembly of
FIG. 203
without the replaceable staple cartridge, a portion of the staple channel
proximate to a middle pin
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of two-piece knife and firing bar, and without a distal portion of a staple
channel;
[0224] FIG. 209 is a front view in elevation taken in cross section along line
209-209 of the
staple applying assembly of FIG. 203 depicting internal staple drivers of the
staple cartridge and
portions of the two-piece knife and firing bar;
[0225] FIG. 210 is a left side view in elevation taken generally along the
longitudinal axis of
line 207-207 of a closed staple applying assembly of FIG. 203 to include
center contact points
between the two-piece knife and wedge sled but also laterally offset to show
staples and staple
drivers within the staple cartridge;
[0226] FIG. 211 is a left side detail view in elevation of the staple applying
assembly of FIG.
210 with the two-piece knife retracted slightly more as typical for staple
cartridge replacement;
[0227] FIG. 212 is a left side detail view in elevation of the staple applying
assembly of FIG.
211 with the two-piece knife beginning to fire, corresponding to the
configuration depicted in
FIG. 210;
[0228] FIG. 213 is a left side cross-sectional view in elevation of the closed
staple applying
assembly of FIG. 210 after the two-piece knife and firing bar has distally
fired;
[0229] FIG. 214 is a left side cross-sectional view in elevation of the closed
staple applying
assembly of FIG. 213 after firing of the staple cartridge and retraction of
the two-piece knife;
[0230] FIG. 215 is a left side cross-sectional detail view in elevation of the
staple applying
assembly of FIG. 214 with the two-piece knife allowed to drop into a lockout
position;
[0231] FIG. 216 is a perspective view of a staple cartridge comprising a rigid
support portion
and a compressible tissue thickness compensator for use with a surgical
stapling instrument in
accordance with at least one embodiment of the invention;
[0232] FIG. 217 is a partially exploded view of the staple cartridge of FIG.
216;
[0233] FIG. 218 is a fully exploded view of the staple cartridge of FIG. 216;
[0234] FIG. 219 is another exploded view of the staple cartridge of FIG. 216
without a warp
covering the tissue thickness compensator;
[0235] FIG. 220 is a perspective view of a cartridge body, or support portion,
of the staple
cartridge of FIG. 216;
[0236] FIG. 221 is a top perspective view of a sled movable within the staple
cartridge of FIG.
216 to deploy staples from the staple cartridge;
[0237] FIG. 222 is a bottom perspective view of the sled of FIG. 221;
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[0238] FIG. 223 is an elevational view of the sled of FIG. 221;
[0239] FIG. 224 is a top perspective view of a driver configured to support
one or more staples
and to be lifted upwardly by the sled of FIG. 221 to eject the staples from
the staple cartridge;
[0240] FIG. 225 is a bottom perspective view of the driver of FIG. 224;
[0241] FIG. 226 is a wrap configured to at least partially surround a
compressible tissue
thickness compensator of a staple cartridge;
[0242] FIG. 227 is a partial cut away view of a staple cartridge comprising a
rigid support
portion and a compressible tissue thickness compensator illustrated with
staples being moved
from an unfired position to a fired position during a first sequence;
[0243] FIG. 228 is an elevational view of the staple cartridge of FIG. 227;
[0244] FIG. 229 is a detail elevational view of the staple cartridge of FIG.
227;
[0245] FIG. 230 is a cross-sectional end view of the staple cartridge of FIG.
227;
[0246] FIG. 231 is a bottom view of the staple cartridge of FIG. 227;
[0247] FIG. 232 is a detail bottom view of the staple cartridge of FIG. 227;
[0248] FIG. 233 is a longitudinal cross-sectional view of an anvil in a closed
position and a
staple cartridge comprising a rigid support portion and a compressible tissue
thickness
compensator illustrated with staples being moved from an unfired position to a
fired position
during a first sequence;
[0249] FIG. 234 is another cross-sectional view of the anvil and the staple
cartridge of FIG.
233 illustrating the anvil in an open position after the firing sequence has
been completed;
[0250] FIG. 235 is a partial detail view of the staple cartridge of FIG. 233
illustrating the
staples in an unfired position;
[0251] FIG. 236 is a cross-sectional elevational view of a staple cartridge
comprising a rigid
support portion and a compressible tissue thickness compensator illustrating
the staples in an
unfired position;
[0252] FIG. 237 is a detail view of the staple cartridge of FIG. 236;
[0253] FIG. 238 is an elevational view of an anvil in an open position and a
staple cartridge
comprising a rigid support portion and a compressible tissue thickness
compensator illustrating
the staples in an unfired position;
[0254] FIG. 239 is an elevational view of an anvil in a closed position and a
staple cartridge
comprising a rigid support portion and a compressible tissue thickness
compensator illustrating
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the staples in an unfired position and tissue captured between the anvil and
the tissue thickness
compensator;
[0255] FIG. 240 is a detail view of the anvil and staple cartridge of FIG.
239;
[0256] FIG. 241 is an elevational view of an anvil in a closed position and a
staple cartridge
comprising a rigid support portion and a compressible tissue thickness
compensator illustrating
the staples in an unfired position illustrating thicker tissue positioned
between the anvil and the
staple cartridge;
[0257] FIG. 242 is a detail view of the anvil and staple cartridge of FIG.
241;
[0258] FIG. 243 is an elevational view of the anvil and staple cartridge of
FIG. 241 illustrating
tissue having different thicknesses positioned between the anvil and the
staple cartridge;
[0259] FIG. 244 is a detail view of the anvil and staple cartridge of FIG. 241
as illustrated in
FIG. 243;
[0260] FIG. 245 is a diagram illustrating a tissue thickness compensator which
is compensating
for different tissue thickness captured within different staples;
[0261] FIG. 246 is a diagram illustrating a tissue thickness compensator
applying a
compressive pressure to one or more vessels that have been transected by a
staple line;
[0262] FIG. 247 is a diagram illustrating a circumstance wherein one or more
staples have
been improperly formed;
[0263] FIG. 248 is a diagram illustrating a tissue thickness compensator which
could
compensate for improperly formed staples;
[0264] FIG. 249 is a diagram illustrating a tissue thickness compensator
positioned in a region
of tissue in which multiple staples lines have intersected;
[0265] FIG. 250 is a diagram illustrating tissue captured within a staple;
[0266] FIG. 251 is a diagram illustrating tissue and a tissue thickness
compensator captured
within a staple;
[0267] FIG. 252 is a diagram illustrating tissue captured within a staple;
[0268] FIG. 253 is a diagram illustrating thick tissue and a tissue thickness
compensator
captured within a staple;
[0269] FIG. 254 is a diagram illustrating thin tissue and a tissue thickness
compensator
captured within a staple;
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[0270] FIG. 255 is a diagram illustrating tissue having an intermediate
thickness and a tissue
thickness compensator captured within a staple;
[0271] FIG. 256 is a diagram illustrating tissue having another intermediate
thickness and a
tissue thickness compensator captured within a staple;
[0272] FIG. 257 is a diagram illustrating thick tissue and a tissue thickness
compensator
captured within a staple;
[0273] FIG. 258 is a partial cross-sectional view of an end effector of a
surgical stapling
instrument illustrating a firing bar and staple-firing sled in a retracted,
unfired position;
[0274] FIG. 259 is another partial cross-sectional view of the end effector of
FIG. 258
illustrating the firing bar and the staple-firing sled in a partially advanced
position;
[0275] FIG. 260 is a cross-sectional view of the end effector of FIG. 258
illustrating the firing
bar in a fully advanced, or fired, position;
[0276] FIG. 261 is a cross-sectional view of the end effector of FIG. 258
illustrating the firing
bar in a retracted position after being fired and the staple-firing sled left
in its fully fired position;
[0277] FIG. 262 is a detail view of the firing bar in the retracted position
of FIG. 261;
[0278] FIG. 263 is a partial cross-sectional view of an end effector of a
surgical stapling
instrument including a staple cartridge comprising a tissue thickness
compensator and staples at
least partially positioned therein;
[0279] FIG. 264 is another partial cross-sectional view of the end effector of
FIG. 263
illustrating the staples at least partially moved and/or rotated relative to
an anvil positioned
opposite the staple cartridge;
[0280] FIG. 265 is a partial cross-sectional view of an end effector of a
surgical stapling
instrument in accordance with at least one embodiment;
[0281] FIG. 266 is a partial cross-sectional view of an end effector in
accordance with at least
one alternative embodiment;
[0282] FIG. 267 is a partial cross-sectional view of an end effector in
accordance with another
alternative embodiment;
[0283] FIG. 268 is a perspective view of an end effector of a surgical
stapling instrument in
accordance with at least one embodiment;
[0284] FIG. 269 is a partial cross-sectional view of the end effector of FIG.
268 illustrated in a
flexed condition;
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[0285] FIG. 270 is a partial cross-sectional view of the end effector of FIG.
269 in a released
condition;
[0286] FIG. 271 is a perspective view of an end effector comprising a tissue
thickness
compensator sock;
[0287] FIG. 272 is a rear perspective of the tissue thickness compensator sock
in FIG. 271;
[0288] FIG. 273 is a perspective view of an end effector comprising a
plurality of rails
extending from a support portion and a tissue thickness compensator having a
longitudinal cavity
defined therein;
[0289] FIG. 274 is a perspective view of the tissue thickness compensator of
FIG. 273;
[0290] FIG. 275 is a perspective view of an end effector comprising a
plurality of teeth
extending from a support portion and a tissue thickness compensator engaged
therewith;
[0291] FIG. 276 is a perspective view of an anvil comprising a pocket array in
accordance with
at least one embodiment;
[0292] FIG. 277 is a partial detail view of the anvil of FIG. 276;
[0293] FIG. 278 is a partial longitudinal cross-sectional view of the anvil of
FIG. 276;
[0294] FIG. 279 is a transverse cross-sectional view of the anvil of FIG. 276;
[0295] FIG. 280 is an elevational view of a fired staple comprising a
substantially B-shaped
configuration;
[0296] FIG. 281 is an elevational view of a fired staple comprising one leg
deformed inwardly
and one leg deformed outwardly;
[0297] FIG. 282 is an elevational view of a fired staple comprising both legs
formed
outwardly;
[0298] FIG. 283 is a partial perspective view of a support portion of a staple
cartridge
comprising detachable and/or displaceable staple leg guides;
[0299] FIG. 284 is a partial cross-sectional view of the staple cartridge of
FIG. 283 illustrating
staples being deployed from the staple cartridge;
[0300] FIG. 285 is a detail view of the cross-sectional view of FIG. 284 after
the staple
cartridge has been fired;
[0301] FIG. 286 is an exploded view of a staple cartridge including a tissue
thickness
compensator comprising voids defined therein;
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[0302] FIG. 287 is a diagram illustrating the tissue thickness compensator of
FIG. 286
implanted against tissue;
[0303] FIG. 288 is another diagram illustrating the tissue thickness
compensator of FIG. 286
implanted against tissue;
[0304] FIG. 289 is a cross-sectional perspective view of a staple cartridge
comprising lateral
retention members extending from a support portion thereof configured to hold
a tissue thickness
compensator in position;
[0305] FIG. 290 is a cross-sectional view of the staple cartridge of FIG. 289
being utilized to
staple tissue;
[0306] FIG. 291 is another cross-sectional view of the staple cartridge of
FIG. 289 illustrating
the support portion being moved away from the implanted tissue thickness
compensator;
[0307] FIG. 292 is a cross-sectional perspective view of a staple cartridge
comprising lateral
retention members configured to hold a tissue thickness compensator to a
support portion;
[0308] FIG. 293 is a cross-sectional view of the staple cartridge of FIG. 292
being utilized to
staple tissue;
[0309] FIG. 294 is another cross-sectional view of the staple cartridge of
FIG. 292 illustrating
the support portion being moved away from the implanted tissue thickness
compensator;
[0310] FIG. 295 is a cross-sectional detail view of a retainer holding a
tissue thickness
compensator to a support portion of a staple cartridge in accordance with at
least one
embodiment;
[0311] FIG. 296 is partial cut-away view of a staple cartridge comprising
staple drivers having
different heights in accordance with at least one embodiment;
[0312] FIG. 296A is a diagram illustrating the staple drivers of FIG. 296 and
staples having
different unfired heights supported thereon;
[0313] FIG. 297 is a diagram illustrating a tissue thickness compensator
comprising a varying
thickness, staple drivers having different heights, and staples having
different unformed heights;
[0314] FIG. 298 is a diagram illustrating the staples and the tissue thickness
compensator of
FIG. 297 implanted to tissue;
[0315] FIG. 299 is a partial cross-sectional view of a staple cartridge
comprising a tissue
thickness compensator comprising a varying thickness in accordance with at
least one
embodiment;
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[0316] FIG. 300 is a cross-sectional view of an end effector of a surgical
stapling instrument in
an open configuration;
[0317] FIG. 301 is cross-sectional view of the end effector of FIG. 300
illustrated in a
partially-fired configuration;
[0318] FIG. 302 is a cross-sectional view of the end effector of FIG. 300
illustrated in a re-
opened configuration;
[0319] FIG. 303 is a cross-sectional view of an end effector of a surgical
stapling instrument
comprising staple drivers having different heights and a contoured deck
surface in accordance
with at least one embodiment;
[0320] FIG. 304 is a cross-sectional view of an end effector of a surgical
stapling instrument
comprising staple drivers having different heights and a stepped deck surface
in accordance with
at least one embodiment;
[0321] FIG. 305 is a perspective view of a staple cartridge being loaded into
an effector of a
surgical stapling instrument utilizing a staple cartridge applicator;
[0322] FIG. 306 is a bottom perspective view of the staple cartridge
applicator of FIG. 305;
[0323] FIG. 307 is a side view of the staple cartridge applicator of FIG. 305
assembled to a
staple cartridge;
[0324] FIG. 308 is a cross-sectional view of the assembly of FIG. 307;
[0325] FIG. 309 is a perspective view of a staple cartridge applicator
assembly further
including an upper tissue thickness compensator positioned on the top surface
of the staple
cartridge applicator in accordance with at least one embodiment;
[0326] FIG. 310 is an exploded view of the upper tissue thickness compensator
and the staple
cartridge applicator of FIG. 309;
[0327] FIG. 310A is an exploded view of a staple cartridge applicator assembly
comprising a
pull member configured to detach an upper tissue thickness compensator adhered
to the staple
cartridge applicator;
[0328] FIG. 311 is a partial exploded view of a staple cartridge applicator
assembly in
accordance with at least one alternative embodiment;
[0329] FIG. 312 is a perspective view of a staple cartridge applicator
assembly comprising an
upper tissue thickness compensator including a plurality of retention features
extending
therefrom and a staple cartridge comprising a lower tissue thickness
compensator;
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[0330] FIG. 313 is an elevational view of the staple cartridge applicator
assembly of FIG. 312
positioned within a staple cartridge channel and an anvil being closed onto
the staple cartridge
applicator assembly;
[0331] FIG. 314 is an elevational view of the anvil of FIG. 313 in a re-opened
position and the
staple cartridge applicator of FIG. 312 being removed from the end effector;
[0332] FIG. 314A is a cross-sectional view of tissue positioned intermediate
the upper tissue
thickness compensator and the lower tissue thickness compensator of FIG. 312;
[0333] FIG. 314B is a cross-sectional view illustrating the upper tissue
thickness compensator
and the lower tissue thickness compensator stapled to the tissue and severed
by a cutting
member;
[0334] FIG. 315 is a diagram illustrating a tissue thickness compensator being
inserted into an
anvil in accordance with at least one embodiment;
[0335] FIG. 316 is a cross-sectional view of the tissue thickness compensator
of FIG. 315;
[0336] FIG. 317 is an exploded view of a tissue thickness compensator and an
anvil in
accordance with at least one alternative embodiment;
[0337] FIG. 318 is a perspective view of staple cartridge applicator assembly
comprising an
upper tissue thickness compensator configured to be attached to an anvil in
accordance with at
least one embodiment;
[0338] FIG. 319 is an elevational view of the staple cartridge applicator
assembly of FIG. 318
positioned within a staple cartridge channel and an anvil being moved toward
the upper tissue
thickness compensator;
[0339] FIG. 320 illustrates the staple cartridge applicator of FIG. 318 being
removed from the
end effector after the upper tissue thickness compensator has been engaged
with the anvil;
[0340] FIG. 321 is a cross-sectional end view of the anvil being moved toward
the upper tissue
thickness compensator of FIG. 318;
[0341] FIG. 322 is a cross-sectional end view of the anvil engaged with the
upper tissue
thickness compensator;
[0342] FIG. 323 is a cross-sectional view of an end effector of a surgical
stapling instrument
comprising a staple cartridge including a segmentable tissue thickness
compensator attached to a
support portion of the staple cartridge by a plurality of fasteners;
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[0343] FIG. 324 is a cross-sectional view of the end effector of FIG. 323
illustrating a firing
member in a partially-fired position;
[0344] FIG. 325 is a cross-sectional view of the end effector of FIG. 323
illustrating the
support portion being moved away from the partially-implanted tissue thickness
compensator;
[0345] FIG. 326 is a partial perspective view of the support portion of FIG.
323;
[0346] FIG. 327 is a perspective view of a staple-deploying sled in accordance
with at least one
embodiment;
[0347] FIG. 328 is an elevational view of the sled of FIG. 327;
[0348] FIG. 329 is a perspective view of an end effector of a surgical
stapling instrument
comprising a staple cartridge including a tissue thickness compensator and a
plurality of staple
guides positioned on the tissue thickness compensator;
[0349] FIG. 330 is a partial cross-sectional view of the tissue thickness
compensator and the
staple guides of FIG. 329 in an unfired configuration;
[0350] FIG. 331 is a partial cross-sectional view of the tissue thickness
compensator and the
staple guides of FIG. 329 in a fired configuration;
[0351] FIG. 332 is a cross-sectional view of a staple cartridge comprising a
tissue thickness
compensator and a support portion in accordance with at least one embodiment;
[0352] FIG. 333 is a partial cross-sectional view of a tissue thickness
compensator, a staple
guide layer, and a staple in an unfired position;
[0353] FIG. 334 is a partial cross-sectional view of a tissue thickness
compensator, a staple
guide layer, and a staple in an unfired position in accordance with at least
one alternative
embodiment;
[0354] FIG. 335 is a partial cross-sectional view of a tissue thickness
compensator, a staple
guide layer, and a staple in an unfired position in accordance with at least
one alternative
embodiment;
[0355] FIG. 336 is a partial cross-sectional view of a tissue thickness
compensator, a staple
guide layer, and a staple in an unfired position in accordance with at least
one alternative
embodiment;
[0356] FIG. 337 is a partial cross-sectional view of a tissue thickness
compensator, a staple
guide layer, and a staple in an unfired position in accordance with at least
one alternative
embodiment;
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[0357] FIG. 338 is a partial cross-sectional view of a tissue thickness
compensator, a staple
guide layer, and a staple in an unfired position in accordance with at least
one alternative
embodiment;
[0358] FIG. 339 is a partial cross-sectional view of a tissue thickness
compensator, a staple
guide layer, and a staple in an unfired position in accordance with at least
one alternative
embodiment;
[0359] FIG. 340 is a detail view of a region surrounding a tip of the staple
of FIG. 339;
[0360] FIG. 341 is a partial cross-sectional view of a tissue thickness
compensator, a staple
guide layer, and a staple in an unfired position in accordance with at least
one alternative
embodiment;
[0361] FIG. 342 is a detail view of a region surrounding a tip of the staple
of FIG. 341;
[0362] FIG. 343 is a partial cross-sectional view of a tissue thickness
compensator, a staple
guide layer, and a staple in an unfired position in accordance with at least
one alternative
embodiment;
[0363] FIG. 344 is a perspective view of a staple guide layer and a plurality
of staples in an
unfired position in accordance with at least one alternative embodiment;
[0364] FIG. 345 is an end view of a tissue thickness compensator configured to
be used with a
circular surgical stapler;
[0365] FIG. 346 is a perspective view of the tissue thickness compensator and
the circular
surgical stapler of FIG. 345;
[0366] FIG. 347 is an end view of a tissue thickness compensator configured to
be used with a
circular surgical stapler in accordance with at least one alternative
embodiment;
[0367] FIG. 348 is a perspective view of the tissue thickness compensator and
the circular
surgical stapler of FIG. 347;
[0368] FIG. 349 is an end view of a tissue thickness compensator configured to
be used with a
circular surgical stapler;
[0369] FIG. 350 is an end view of the tissue thickness compensator of FIG. 349
in a partially
expanded configuration;
[0370] FIG. 351 is an elevational view of a surgical stapling instrument
comprising a staple
cartridge in accordance with at least one embodiment;
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[0371] FIG. 352 is an end view of the surgical stapling instrument of FIG. 351
positioned
relative to tissue;
[0372] FIG. 353 is an end view of the surgical stapling instrument of FIG. 351
further
comprising a tissue thickness compensator positioned between the staple
cartridge and the tissue;
[0373] FIG. 354 is a partial perspective view of staples deployed into tissue
from the surgical
stapling instrument of FIG. 351 without a tissue thickness compensator;
[0374] FIG. 355 is a partial perspective view of staples deployed into tissue
from the surgical
stapling instrument of FIG 351 with a tissue thickness compensator;
[0375] FIG. 356 is a partial cross-sectional view of the end effector of the
surgical stapling
instrument of FIG. 351 comprising an anvil plate in a first position;
[0376] FIG. 357 is a partial cross-sectional view of the end effector of the
surgical stapling
instrument of FIG. 351 illustrating the anvil plate of FIG. 356 in a second
position;
[0377] FIG. 358 is a cross-sectional view of an end effector of a surgical
stapling instrument
comprising a staple cartridge including a gap setting element;
[0378] FIG. 359 is a perspective view illustrating a firing member cutting the
gap setting
element of FIG. 358 at the end of firing stroke of the firing member;
[0379] FIG. 360 is a cross-sectional view of an end effector of a surgical
stapling instrument
comprising a staple cartridge including a flexible nose;
[0380] FIG. 361 is a cross-sectional view of the end effector of FIG. 360
illustrating the nose in
a flexed configuration;
[0381] FIG. 362 is a cross-sectional view of an end effector of a surgical
stapling instrument
comprising a staple cartridge including a slidable portion;
[0382] FIG. 363 is a cross-sectional view of the end effector of FIG. 362
illustrating the
slidable portion slid distally;
[0383] FIG. 364 is a cross-sectional view of an end effector of a surgical
stapling instrument
comprising a support portion comprising an inclined deck surface and a tissue
thickness
compensator comprising a varying thickness;
[0384] FIG. 365 is a cross-sectional view of an end effector of a surgical
stapling instrument
comprising a support portion comprising an inclined deck surface and a tissue
thickness
compensator comprising a uniform thickness;
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[0385] FIG. 366 is a perspective view of a staple cartridge comprising a
tissue thickness
compensator having a varying thickness;
[0386] FIG. 367 is an end view of the staple cartridge of FIG. 366;
[0387] FIG. 368 is a cross-sectional perspective view of a tissue thickness
compensator
comprising longitudinal layers;
[0388] FIG. 369 is a cross-sectional perspective view of a tissue thickness
compensator
comprising a plurality of layers in accordance with at least one alternative
embodiment;
[0389] FIG. 370 is a perspective view of a disposable loading unit comprising
retention
members configured to releasably hold a tissue thickness compensator thereto;
[0390] FIG. 371 is a perspective view of a tissue thickness compensator
including retention
members configured to releasably hold the tissue thickness compensator to a
disposable loading
unit;
[0391] FIG. 372 is a perspective view of the tissue thickness compensator of
FIG. 371 attached
to a disposable loading unit;
[0392] FIG. 373 is an end view of the disposable loading unit of FIG. 372;
[0393] FIG. 374 is a perspective view of a tissue thickness compensator
including retention
members configured to releasably hold the tissue thickness compensator to a
disposable loading
unit;
[0394] FIG. 375 is a perspective view of the tissue thickness compensator of
FIG. 374 attached
to a disposable loading unit;
[0395] FIG. 376 is an end view of the disposable loading unit of FIG. 375;
[0396] FIG. 377 is a perspective view of a tissue thickness compensator
including a retention
member configured to releasably hold the tissue thickness compensator to a
disposable loading
unit;
[0397] FIG. 378 is a perspective view of the tissue thickness compensator of
FIG. 377 attached
to a disposable loading unit;
[0398] FIG. 379 is a perspective view of a tissue thickness compensator
applicator positioned
within an effector of a disposable loading unit;
[0399] FIG. 380 is a top perspective view of the tissue thickness compensator
applicator of
FIG. 379;
28
104001 FIG. 381 is a bottom perspective view of the tissue thickness
compensator applicator of
FIG. 379;
[0401] FIG. 382 is a perspective view of a tissue thickness compensator
applicator positioned
within an effector of a disposable loading unit in accordance with at least
one alternative
embodiment;
104021 FIG. 383 is a top perspective view of the tissue thickness compensator
applicator of
FIG. 382;
(0403] FIG. 384 is a bottom perspective view of the tissue thickness
compensator applicator of
FIG. 382;
[0404] FIG. 385 is an elevational view of a disposable loading unit including
a pivotable jaw
configured to support a staple cartridge;
[0405] FIG. 386 is a cross-sectional view of a staple cartridge comprising a
tissue thickness
compensator attached to a support portion of the staple cartridge in
accordance with at least one
embodiment;
[0406] FIG. 387 is a cross-sectional view of a staple cartridge comprising a
tissue thickness
compensator attached to a support portion of the staple cartridge in
accordance with at least one
embodiment;
[0407] FIG. 388 is a cross-sectional view of a staple cartridge comprising a
tissue thickness
compensator attached to a support portion of the staple cartridge in
accordance with at least one
embodiment; and
[0408] FIG. 389 is a perspective view of the tissue thickness compensator of
FIG. 387.
[0409] Corresponding reference characters indicate corresponding parts
throughout the several
views. The exemplifications set out herein illustrate certain embodiments of
the invention, in
one form, and such exemplifications are not to be construed as limiting the
scope of the
invention in any manner.
DETAILED DESCRIPTION
[0410] The Applicant of the present application also owns the U.S. Patent
Applications
identified below which were filed on September 30, 2010:
U.S. Patent Application Serial No. 12/894,360, now U.S. Patent Publication No.
2012/0080484, entitled "Surgical Stapling Instrument With a Variable Staple
Forming System":
29
CA 2834421 2018-07-11
U.S. Patent Application Serial No. 12/894,322, now U.S. Patent No. 8,740,034,
entitled
"Surgical Stapling Instrument With Interchangeable Staple Cartridge
Arrangements";
U.S. Patent Application Serial No. 12/894,351, now U.S. Patent No. 9,113,864,
entitled
"Surgical Cutting and Fastening Instruments With Separate and Distinct
Fastener Deployment
and Tissue Cutting Systems";
U.S. Patent Application Serial No. 12/894,339, now U.S. Patent No. 8,840,003,
entitled
"Surgical Stapling Instrument With Compact Articulation Control Arrangement";
U.S. Patent Application Serial No. 12/894,327, now U.S. Patent No. 8,978,956,
entitled
"Jaw Closure Arrangements For Surgical Instruments";
U.S. Patent Application Serial No. 12/894,311, now U.S. Patent No. 8,763,877,
entitled
"Surgical Instruments With Reconfigurable Shaft Segments";
U.S. Patent Application Serial No. 12/894,340, now U.S. Patent No. 8,899,463,
entitled
"Surgical Staple Cartridges Supporting Non-Linearly Arranged Staples and
Surgical Stapling
Instruments With Common Staple-Forming Pockets";
U.S. Patent Application Serial No. 12/894,350, now U.S. Patent Publication No.
2012/0080478, entitled "Surgical Staple Cartridges With Detachable Support
Structures and
Surgical Stapling Instruments With Systems For Preventing Actuation Motions
When a
Cartridge is Not Present";
U.S. Patent Application Serial No. 12/894,338, now U.S. Patent No. 8,864,007,
entitled
"Implantable Fastener Cartridge Having a Non-Uniform Arrangement";
U.S. Patent Application Serial No. 12/894,312, now U.S. Patent No. 8,925,782,
entitled
"Implantable Fastener Cartridge Comprising Multiple Layers";
U.S. Patent Application Serial No. 12/894,377, now U.S. Patent No. 8,393,514,
entitled
"Selectively Orientable Implantable Fastener Cartridge";
U.S. Patent Application Serial No. 12/894,383, now U.S. Patent No. 8,752,699,
entitled
"Implantable Fastener Cartridge Comprising Bioabsorbable Layers";
U.S. Patent Application Serial No. 12/894,389, now U.S. Patent No. 8,740,037,
entitled
"Compressible Fastener Cartridge";
U.S. Patent Application Serial No. 12/894,345, now U.S. Patent No. 8,783,542,
entitled
"Fasteners Supported By a Fastener Cartridge Support";
CA 2834421 2018-07-11
U.S. Patent Application Serial No. 12/894,306, now U.S. Patent No. 9,044,227,
entitled
"Collapsible Fastener Cartridge";
U.S. Patent Application Serial No. 12/894,318, now U.S. Patent No. 8,814,024,
entitled
"Fastener System Comprising a Plurality of Connected Retention Matrix
Elements";
U.S. Patent Application Serial No. 12/894,330, now U.S. Patent No. 8,757,465,
entitled
"Fastener System Comprising a Retention Matrix and an Alignment Matrix";
U.S. Patent Application Serial No. 12/894,361, now U.S. Patent No. 8,529,600,
entitled
"Fastener System Comprising a Retention Matrix";
U.S. Patent Application Serial No. 12/894,367, now U.S. Patent No. 9,033,203,
entitled
"Fastening Instrument For Deploying a Fastener System Comprising a Retention
Matrix";
U.S. Patent Application Serial No. 12/894,388, now U.S. Patent No. 8,474,677,
entitled
"Fastener System Comprising a Retention Matrix and a Cover";
U.S. Patent Application Serial No. 12/894,376, now U.S. Patent No. 9,044,228,
entitled
"Fastener System Comprising a Plurality of Fastener Cartridges"; and
U.S. Patent Application Serial No. 12/894,369, now U.S. Patent Publication No.
2012/0080344, entitled "Implantable Fastener Cartridge Comprising a Support
Retainer".
104111 The Applicant of the present application also owns the U.S. Patent
Applications
identified below which were filed on even date herewith:
U.S. Patent Application Serial No. 12/894,360, now U.S. Patent No. 9,113,862,
entitled
"Compressible Staple Cartridge Assembly";
U.S. Patent Application Serial No. 12/894,322, now U.S. Patent No. 8,740,034,
entitled
"Tissue Thickness Compensator Comprising Portions Having Different
Properties";
U.S. Patent Application Serial No. 12/894,339, now U.S. Patent No. 8,840,003,
entitled
"Staple Cartridge Comprising an Adjustable Distal Portion";
U.S. Patent Application Serial No. 12/894,327, now U.S. Patent No. 8,978,956,
entitled
"Tissue Thickness Compensator For a Surgical Stapler";
U.S. Patent Application Serial No. 12/894,340, now U.S. Patent No. 8,899,463,
entitled
"Surgical Stapler Anvil Comprising a Plurality of Forming Pockets";
U.S. Patent Application Serial No. 12/894,350, now U.S. Patent Publication No.
2012/0080478, entitled "Staple Cartridge Loading Assembly";
31
CA 2834421 2018-07-11
U.S. Patent Application Serial No. 12/894,338, now U.S. Patent No. 8,864,007,
entitled
"Staple Cartridge Comprising a Variable Thickness Compressible Portion";
U.S. Patent Application Serial No. 12/894,312, now U.S. Patent No. 8,925,782,
entitled
"Tissue Thickness Compensator Comprising Detachable Portions";
U.S. Patent Application Serial No. 12/894,377, now U.S. Patent No. 8,393,514,
entitled
"Tissue Thickness Compensator For a Surgical Stapler Comprising an Adjustable
Anvil";
U.S. Patent Application Serial No. 12/894,389, now U.S. Patent No. 8,740,037,
entitled
"Staple Cartridge Comprising a Releasable Portion";
U.S. Patent Application Serial No. 12/894,345, now U.S. Patent No. 8,783,542,
entitled
"Staple Cartridge Comprising Compressible Distortion Resistant Components";
U.S. Patent Application Serial No. 12/894,306, now U.S. Patent No. 9,044,227,
entitled
"Staple Cartridge Comprising a Tissue Thickness Compensator"; and
U.S. Patent Application Serial No. 12/894,369, now U.S. Patent Publication No.
20120080344, entitled "Staple Cartridge Comprising Staples Positioned Within a
Compressible
Portion Thereof'.
j0412] Certain exemplary embodiments will now be described to provide an
overall
understanding of the principles of the structure, function, manufacture, and
use of the devices
and methods disclosed herein. One or more examples of these embodiments are
illustrated in the
accompanying drawings. Those of ordinary skill in the art will understand that
the devices and
methods specifically described herein and illustrated in the accompanying
drawings are non-
limiting exemplary embodiments and that the scope of the various embodiments
of the present
invention is defined solely by the claims. The features illustrated or
described in connection with
one exemplary embodiment may be combined with the features of other
embodiments. Such
modifications and variations are intended to be included within the scope of
the present
invention.
104131 Reference throughout the specification to "various embodiments," "some
embodiments," "one embodiment," or "an embodiment", or the like, means that a
particular
feature, structure, or characteristic described in connection with the
embodiment is included in at
32
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least one embodiment. Thus, appearances of the phrases "in various
embodiments," "in some
embodiments," "in one embodiment", or "in an embodiment", or the like, in
places throughout
the specification are not necessarily all referring to the same embodiment.
Furthermore, the
particular features, structures, or characteristics may be combined in any
suitable manner in one
or more embodiments. Thus, the particular features, structures, or
characteristics illustrated or
described in connection with one embodiment may be combined, in whole or in
part, with the
features structures, or characteristics of one or more other embodiments
without limitation. Such
modifications and variations are intended to be included within the scope of
the present
invention.
[0414] The terms "proximal" and "distal" are used herein with reference to a
clinician
manipulating the handle portion of the surgical instrument. The term
"proximal" referring to the
portion closest to the clinician and the term "distal" referring to the
portion located away from
the clinician. It will be further appreciated that, for convenience and
clarity, spatial terms such
as "vertical", "horizontal", "up", and "down" may be used herein with respect
to the drawings.
However, surgical instruments are used in many orientations and positions, and
these terms are
not intended to be limiting and/or absolute.
[0415] Various exemplary devices and methods are provided for performing
laparoscopic and
minimally invasive surgical procedures. However, the person of ordinary skill
in the art will
readily appreciate that the various methods and devices disclosed herein can
be used in numerous
surgical procedures and applications including, for example, in connection
with open surgical
procedures. As the present Detailed Description proceeds, those of ordinary
skill in the art will
further appreciate that the various instruments disclosed herein can be
inserted into a body in any
way, such as through a natural orifice, through an incision or puncture hole
formed in tissue, etc.
The working portions or end effector portions of the instruments can be
inserted directly into a
patient's body or can be inserted through an access device that has a working
channel through
which the end effector and elongated shaft of a surgical instrument can be
advanced.
[0416] Turning to the Drawings wherein like numerals denote like components
throughout the
several views, FIG. 1 depicts a surgical instrument 10 that is capable of
practicing several unique
benefits. The surgical stapling instrument 10 is designed to manipulate and/or
actuate various
forms and sizes of end effectors 12 that are operably attached thereto. In the
embodiment
depicted in FIGS. 1-1E, for example, the end effector 12 includes an elongated
channel 14 that
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forms a lower jaw 13 of the end effector 12. The elongated channel 14 is
configured to support
an "implantable" staple cartridge 30 and also movably support an anvil 20 that
functions as an
upper jaw 15 of the end effector 12.
[04171 In various embodiments, the elongated channel 14 may be fabricated
from, for example,
300 & 400 Series, 17-4 & 17-7 stainless steel, titanium, etc. and be formed
with spaced side
walls 16. The anvil 20 may be fabricated from, for example, 300 & 400 Series,
17-4 & 17-7
stainless steel, titanium, etc. and have a staple forming undersurface,
generally labeled as 22 that
has a plurality of staple forming pockets 23 formed therein. See FIGS. 1B-1E.
In addition, the
anvil 20 has a bifurcated ramp assembly 24 that protrudes proximally
therefrom. An anvil pin 26
protrudes from each lateral side of the ramp assembly 24 to be received within
a corresponding
slot or opening 18 in the side walls 16 of the elongated channel 14 to
facilitate its movable or
pivotable attachment thereto.
[0418] Various forms of implantable staple cartridges may be employed with the
various
embodiments of the surgical instruments disclosed herein. Specific staple
cartridge
configurations and constructions will be discussed in further detail below.
However, in the
embodiment depicted in FIG. 1A, an implantable staple cartridge 30 is shown.
In at least one
embodiment, the staple cartridge 30 has a body portion 31 that consists of a
compressible
hemostat material such as, for example, oxidized regenerated cellulose ("ORC")
or a bio-
absorbable foam in which lines of unformed metal staples 32 are supported. In
at least some
embodiments, in order to prevent the staple from being affected and the
hemostat material from
being activated during the introduction and positioning process, the entire
cartridge may be
coated or wrapped in a biodegradable film 38 such as a polydioxanon film sold
under the
trademark PDSO or with a Polyglycerol sebacate (PGS) film or other
biodegradable films
formed from PGA (Polyglycolic acid, marketed under the trade mark Vicryl), PCL
(Polycaprolactone), PLA or PLLA (Polylactic acid), PHA (polyhydroxyalkanoate),
PGCL
(poliglecaprone 25, sold under the trademark Monocryl) or a composite of PGA,
PCL, PLA,
PDS that would be impermeable until ruptured. The body 31 of staple cartridge
30 is sized to be
removably supported within the elongated channel 14 as shown such that each
staple 32 therein
is aligned with corresponding staple forming pockets 23 in the anvil when the
anvil 20 is driven
into forming contact with the staple cartridge 30.
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[0419] In use, once the end effector 12 has been positioned adjacent the
target tissue, the end
effector 12 is manipulated to capture or clamp the target tissue between an
upper face 36 of the
staple cartridge 30 and the staple forming surface 22 of the anvil 20. The
staples 32 are formed
by moving the anvil 20 in a path that is substantially parallel to the
elongated channel 14 to bring
the staple forming surface 22 and, more particularly, the staple forming
pockets 23 therein into
substantially simultaneous contact with the upper face 36 of the staple
cartridge 30. As the anvil
20 continues to move into the staple cartridge 30, the legs 34 of the staples
32 contact a
corresponding staple forming pocket 23 in anvil 20 which serves to bend the
staple legs 34 over
to form the staples 32 into a "B shape". Further movement of the anvil 20
toward the elongated
channel 14 will further compress and form the staples 32 to a desired final
formed height "FF".
[0420] The above-described staple forming process is generally depicted in
FIGS. 1B-1E. For
example, FIG. 1B illustrates the end effector 12 with target tissue "T"
between the anvil 20 and
the upper face 36 of the implantable staple cartridge 30. FIG. 1C illustrates
the initial clamping
position of the anvil 20 wherein the anvil has 20 been closed onto the target
tissue "T" to clamp
the target tissue "T" between the anvil 20 and the upper face 36 of the staple
cartridge 30. FIG.
ID illustrates the initial staple formation wherein the anvil 20 has started
to compress the staple
cartridge 30 such that the legs 34 of the staples 32 are starting to be formed
by the staple forming
pockets 23 in the anvil 20. FIG. lE illustrates the staple 32 in its final
formed condition through
the target tissue "T" with the anvil 20 removed for clarity purposes. Once the
staples 32 have
been formed and fastened to the target tissue "T", the surgeon will move the
anvil 20 to the open
position to enable the cartridge body 31 and the staples 32 to remain affixed
to the target tissue
while the end effector 12 is being withdrawn from the patient. The end
effector 12 forms all of
the staples simultaneously as the two jaws 13, 15 are clamped together. The
remaining
"crushed- body materials 31 act as both a hemostat (the ORC) and a staple line
reinforcement
(PGA, PDS or any of the other film compositions mentioned above 38). Also,
since the staples
32 never have to leave the cartridge body 31 during forming, the likelihood of
the staples 32
being malformed during forming is minimized. As used herein the term
"implantable" means
that, in addition to the staples, the cartridge body materials that support
the staples will also
remain in the patient and may eventually be absorbed by the patient's body.
Such implantable
staple cartridges are distinguishable from prior cartridge arrangements that
remain positioned
within the end effector in their entirety after they have been fired.
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[0421] In various implementations, the end effector 12 is configured to be
coupled to an
elongated shaft assembly 40 that protrudes from a handle assembly 100. The end
effector 12
(when closed) and the elongated shaft assembly 40 may have similar cross-
sectional shapes and
be sized to operably pass through a trocar tube or working channel in another
form of access
instrument. As used herein, the term "operably pass" means that the end
effector and at least a
portion of the elongated shaft assembly may be inserted through or passed
through the channel or
tube opening and can be manipulated therein as needed to complete the surgical
stapling
procedure. In some embodiments, when in a closed position, the jaws 13 and 15
of the end
effector 12 may provide the end effector with a roughly circular cross-
sectional shape that
facilitates its passage through a circular passage/opening. However, the end
effectors of various
embodiments of the present invention, as well as the elongated shaft assembly
embodiments,
could conceivably be provided with other cross-sectional shapes that could
otherwise pass
through access passages and openings that have non-circular cross-sectional
shapes. Thus, an
overall size of a cross-section of a closed end effector will be related to
the size of the passage or
opening through which it is intended to pass. Thus, one end effector for
example, may be
referred to as a "5mm" end effector which means it can operably pass through
an opening that is
at least approximately 5mm in diameter.
[0422] In various embodiments, the elongated shaft assembly 40 may have an
outer diameter
that is substantially the same as the outer diameter of the end effector 12
when in a closed
position. For example, a 5mm end effector may be coupled to an elongated shaft
assembly 40
that has 5mm cross-sectional diameter. However, as the present Detailed
Description proceeds,
it will become apparent that various embodiments of the present may be
effectively used in
connection with different sizes of end effectors. For example, a lOmm end
effector may be
attached to an elongated shaft that has a 5mm cross-sectional diameter.
Conversely, for those
applications wherein a lOmm or larger access opening or passage is provided,
the elongated shaft
assembly 40 may have a lOmm (or larger) cross-sectional diameter, but may also
be able to
actuate a 5mm or lOmm end effector. Accordingly, the outer shaft 40 may have
an outer
diameter that is the same as or is different from the outer diameter of a
closed end effector 12
attached thereto.
[0423] As depicted, the elongated shaft assembly 40 extends distally from the
handle assembly
100 in a generally straight line to define a longitudinal axis A-A. In various
embodiments, for
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example, the elongated shaft assembly 40 may be approximately 9-16 inches (229-
406mm) long.
However, the elongated shaft assembly 40 may be provided in other lengths and,
in other
embodiments, may have joints therein or be otherwise configured to facilitate
articulation of the
end effector 12 relative to other portions of the shaft or handle assembly as
will be discussed in
further detail below. In various embodiments, the elongated shaft assembly 40
includes a spine
member 50 that extends from the handle assembly 100 to the end effector 12.
The proximal end
of the elongated channel 14 of the end effector 12 has a pair of retention
trunnions 17 protruding
therefrom that are sized to be received within corresponding trunnion openings
or cradles 52 that
are provided in a distal end of the spine member 50 to enable the end effector
12 to be removably
coupled the elongated shaft assembly 40. The spine member 50 may be fabricated
from, for
example, 6061 or 7075 aluminum, stainless steel, titanium, etc.
[0424] In various embodiments, the handle assembly 100 comprises a pistol grip-
type housing
that may be fabricated in two or more pieces for assembly purposes. For
example, the handle
assembly 100 as shown comprises a right hand case member 102 and a left hand
case member
(not illustrated) that are molded or otherwise fabricated from a polymer or
plastic material and
are designed to mate together. Such case members may be attached together by
snap features,
pegs and sockets molded or otherwise formed therein and/or by adhesive,
screws, etc. The spine
member 50 has a proximal end 54 that has a flange 56 formed thereon. The
flange 56 is
configured to be rotatably supported within a groove 106 formed by mating ribs
108 that
protrude inwardly from each of the case members 102, 104. Such arrangement
facilitates the
attachment of the spine member 50 to the handle assembly 100 while enabling
the spine member
50 to be rotated relative to the handle assembly 100 about the longitudinal
axis A-A in a 360'
path.
[0425] As can be further seen in FIG. 1, the spine member 50 passes through
and is supported
by a mounting bushing 60 that is rotatably affixed to the handle assembly 100.
The mounting
bushing 60 has a proximal flange 62 and a distal flange 64 that define a
rotational groove 65 that
is configured to rotatably receive a nose portion 101 of the handle assembly
100 therebetween.
Such arrangement enables the mounting bushing 60 to rotate about longitudinal
axis A-A relative
to the handle assembly 100. The spine member 50 is non-rotatably pinned to the
mounting
bushing 60 by a spine pin 66. In addition, a rotation knob 70 is attached to
the mounting bushing
60. In one embodiment, for example, the rotation knob 70 has a hollow mounting
flange portion
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72 that is sized to receive a portion of the mounting bushing 60 therein. In
various embodiments,
the rotation knob 70 may be fabricated from, for example, glass or carbon
filled Nylon,
polycarbonate, Ultem , etc. and is affixed to the mounting bushing 60 by the
spine pin 66 as
well. In addition, an inwardly protruding retention flange 74 is formed on the
mounting flange
portion 72 and is configured to extend into a radial groove 68 formed in the
mounting bushing
60. Thus, the surgeon may rotate the spine member 50 (and the end effector 12
attached thereto)
about longitudinal axis A-A in a 360' path by grasping the rotation knob 70
and rotating it
relative to the handle assembly 100.
[0426] In various embodiments, the anvil 20 is retained in an open position by
an anvil spring
21 and/or another biasing arrangement. The anvil 20 is selectively movable
from the open
position to various closed or clamping and firing positions by a firing
system, generally
designated as 109. The firing system 109 includes a "firing member" 110 which,
in various
embodiments, comprises a hollow firing tube 110. The hollow firing tube 110 is
axially movable
on the spine member 50 and thus forms the outer portion of the elongated shaft
assembly 40.
The firing tube 110 may be fabricated from a polymer or other suitable
material and have a
proximal end that is attached to a firing yoke 114 of the firing system 109.
In various
embodiments for example, the firing yoke 114 may be over-molded to the
proximal end of the
firing tube 110. However, other fastener arrangements may be employed.
[0427] As can be seen in FIG. 1, the firing yoke 114 may be rotatably
supported within a
support collar 120 that is configured to move axially within the handle
assembly 100. In various
embodiments, the support collar 120 has a pair of laterally extending fins
that are sized to be
slidably received within fin slots formed in the right and left hand case
members. Thus, the
support collar 120 may slide axially within the handle housing 100 while
enabling the firing
yoke 114 and firing tube 110 to rotate relative thereto about the longitudinal
axis A-A. In
various embodiments, a longitudinal slot is provided through the firing tube
110 to enable the
spine pin 66 to extend therethrough into the spine member 50 while
facilitating the axial travel of
the firing tube 110 on the spine member 50.
[0428] The firing system 109 further comprises a firing trigger 130 which
serves to control the
axial travel of the firing tube 110 on the spine member 50. See FIG. 1. Such
axial movement in
the distal direction of the firing tube 110 into firing interaction with the
anvil 20 is referred to
herein as "firing motion". As can be seen in FIG. 1, the firing trigger 130 is
movably or
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pivotally coupled to the handle assembly 100 by a pivot pin 132. A torsion
spring 135 is
employed to bias the firing trigger 130 away from the pistol grip portion 107
of the handle
assembly 100 to an un-actuated "open" or starting position. As can be seen in
FIG. 1, the firing
trigger 130 has an upper portion 134 that is movably attached to (pinned)
firing links 136 that are
movably attached to (pinned) the support collar 120. Thus, movement of the
firing trigger 130
from the starting position (FIG. 1) toward an ending position adjacent the
pistol grip portion 107
of the handle assembly 100 will cause the firing yoke 114 and the firing tube
110 to move in the
distal direction "DD". Movement of the firing trigger 130 away from the pistol
grip portion 107
of the handle assembly 100 (under the bias of the torsion spring 135) will
cause the firing yoke
114 and firing tube 110 to move in the proximal direction "PD" on the spine
member 50.
[0429] Various embodiments of the present invention may be employed with
different sizes
and configurations of implantable staple cartridges. For example, the surgical
instrument 10,
when used in connection with a first firing adapter 140, may be used with a
5mm end effector 12
that is approximately 20mm long (or in other lengths) which supports an
implantable staple
cartridge 30. Such end effector size may be particularly well-suited, for
example, to complete
relatively fine dissection and vascular transactions. However, as will be
discussed in further
detail below, the surgical instrument 10 may also be employed, for example, in
connection with
other sizes of end effectors and staple cartridges by replacing the first
firing adapter 140 with a
second firing adapter. In still other embodiments, the elongated shaft
assembly 40 may
configured to be attached to only one form or size of end effector.
[0430] One method of removably coupling the end effector 12 to the spine
member 50 will
now be explained. The coupling process is commenced by inserting the retention
trunnions 17
on the elongated channel 14 into the trunnion cradles 52 in the spine member
50. Thereafter, the
surgeon advances the firing trigger 130 toward the pistol grip 107 of the
housing assembly 100 to
distally advance the firing tube 110 and the first firing adapter 140 over a
proximal end portion
47 of the elongated channel 14 to thereby retain the trunnions 17 in their
respective cradles 52.
Such position of the first firing adapter 140 over the trunnions 17 is
referred to herein as the
"coupled position". Various embodiments of the present invention may also have
an end
effector locking assembly for locking the firing trigger 130 in position after
an end effector 12
has been attached to the spine member 50.
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[0431] More specifically, one embodiment of the end effector locking assembly
160 includes a
retention pin 162 that is movably supported in the upper portion 134 of the
firing trigger 130. As
discussed above, the firing tube 110 must initially be advanced distally to
the coupled position
wherein the first firing adapter 140 retains the retention trunnions 17 of the
end effector 12 in the
trunnion cradles 52 in the spine member 50. The surgeon advances the firing
adapter 140
distally to the coupled position by pulling the firing trigger 130 from the
starting position toward
the pistol grip 107. As the firing trigger 130 is initially actuated, the
retention pin 162 is moved
distally until the firing tube 110 has advanced the first firing adapter 140
to the coupled position
at which point the retention pin 162 is biased into a locking cavity 164
formed in the case
member. In various embodiments, when the retention pin 162 enters into the
locking cavity 164,
the pin 162 may make an audible "click" or other sound, as well as provide a
tactile indication to
the surgeon that the end effector 12 has been "locked" onto the spine member
50. In addition,
the surgeon cannot inadvertently continue to actuate the firing trigger 130 to
start to form staples
32 in the end effector 12 without intentionally biasing the retention pin 162
out of the locking
cavity 164. Similarly, if the surgeon releases the firing trigger 130 when in
the coupled position,
it is retained in that position by the retention pin 162 to prevent the firing
trigger 130 from
returning to the starting position and thereby releasing the end effector 12
from the spine
member 50.
[0432] Various embodiments of the present invention may further include a
firing system lock
button 137 that is pivotally attached to the handle assembly 100. In one form,
the firing system
lock button 137 has a latch 138 formed on a distal end thereof that is
oriented to engage the
firing yoke 114 when the firing release button is in a first latching
position. As can be seen in
FIG. 1, a latch spring 139 serves to bias the firing system lock button 137 to
the first latching
position. In various circumstances, the latch 138 serves to engage the firing
yoke 114 at a point
where the position of the firing yoke 114 on the spine member 50 corresponds
to a point wherein
the first firing adapter 140 is about to distally advance up the clamping ramp
28 on the anvil 20.
It will be understood that, as the first firing adapter 140 advances axially
up the clamping ramp
28, the anvil 20 will move in a path such that its staple forming surface
portion 22 is
substantially parallel to the upper face 36 of the staple cartridge 30.
[0433] After the end effector 12 has been coupled to the spine member 50, the
staple forming
process is commenced by first depressing the firing system lock button 137 to
enable the firing
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yoke 114 to be further moved distally on the spine member 50 and ultimately
compress the anvil
20 into the staple cartridge 30. After depressing the firing system lock
button 137, the surgeon
continues to actuate the firing trigger 130 towards the pistol grip 107
thereby driving the first
staple collar 140 up the corresponding staple forming ramp 29 to force the
anvil 20 into forming
contact with the staples 32 in the staple cartridge 30. The firing system lock
button 137 prevents
the inadvertent forming of the staples 32 until the surgeon is ready to start
that process. In this
embodiment, the surgeon must depress the firing system lock button 137 before
the firing trigger
130 may be further actuated to begin the staple forming process.
[0434] The surgical instrument 10 may be solely used as a tissue stapling
device if so desired.
However, various embodiments of the present invention may also include a
tissue cutting
system, generally designated as 170. In at least one form, the tissue cutting
system 170
comprises a knife member 172 that may be selectively advanced from an un-
actuated position
adjacent the proximal end of the end effector 12 to an actuated position by
actuating a knife
advancement trigger 200. The knife member 172 is movably supported within the
spine member
50 and is attached or otherwise protrudes from a knife rod 180. The knife
member 172 may be
fabricated from, for example, 420 or 440 stainless steel with a hardness of
greater than 38HRC
(Rockwell Hardness C-scale) and have a tissue cutting edge 176 formed on the
distal end 174
thereof and be configured to slidably extend through a slot in the anvil 20
and a centrally
disposed slot 33 in the staple cartridge 30 to cut through tissue that is
clamped in the end effector
12. In various embodiments, the knife rod 180 extends through the spine member
50 and has a
proximal end portion which drivingly interfaces with a knife transmission that
is operably
attached to the knife advance trigger 200. In various embodiments, the knife
advance trigger 200
is attached to pivot pin 132 such that it may be pivoted or otherwise actuated
without actuating
the firing trigger 130. In various embodiments, a first knife gear 192 is also
attached to the pivot
pin 132 such that actuation of the knife advance trigger 200 also pivots the
first knife gear 192.
A firing return spring 202 is attached between the first knife gear 192 and
the handle housing
100 to bias the knife advancement trigger 200 to a starting or un-actuated
position.
[0435] Various embodiments of the knife transmission also include a second
knife gear 194 that
is rotatably supported on a second gear spindle and in meshing engagement with
the first knife
gear 192. The second knife gear 194 is in meshing engagement with a third
knife gear 196 that
is supported on a third gear spindle. Also supported on the third gear spindle
195 is a fourth
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knife gear 198. The fourth knife gear 198 is adapted to drivingly engage a
series of annular gear
teeth or rings on a proximal end of the knife rod 180. Thus, such arrangement
enables the fourth
knife gear 198 to axially drive the knife rod 180 in the distal direction "DD"
or proximal
direction "PD" while enabling the firing rod 180 to rotate about longitudinal
axis A-A with
respect to the fourth knife gear 198. Accordingly, the surgeon may axially
advance the firing rod
180 and ultimately the knife member 172 distally by pulling the knife
advancement trigger 200
towards the pistol grip 107 of the handle assembly 100.
[0436] Various embodiments of the present invention further include a knife
lockout system
210 that prevents the advancement of the knife member 172 unless the firing
trigger 130 has
been pulled to the fully fired position. Such feature will therefore prevent
the activation of the
knife advancement system 170 unless the staples have first been fired or
formed into the tissue.
As can be seen in FIG. 1, various implementations of the knife lockout system
210 comprise a
knife lockout bar 211 that is pivotally supported within the pistol grip
portion 107 of the handle
assembly 100. The knife lockout bar 211 has an activation end 212 that is
adapted to be engaged
by the firing trigger 130 when the firing trigger 130 is in the fully fired
position. In addition, the
knife lockout bar 211 has a retaining hook 214 on its other end that is
adapted to hookingly
engage a latch rod 216 on the first cut gear 192. A knife lock spring 218 is
employed to bias the
knife lockout bar 211 to a "locked" position wherein the retaining hook 214 is
retained in
engagement with the latch rod 216 to thereby prevent actuation of the knife
advancement trigger
200 unless the firing trigger 130 is in the fully fired position.
[0437] After the staples have been "fired" (formed) into the target tissue,
the surgeon may
depress the firing trigger release button 167 to enable the firing trigger 130
to return to the
starting position under the bias of the torsion spring 135 which enables the
anvil 20 to be biased
to an open position under the bias of spring 21. When in the open position,
the surgeon may
withdraw the end effector 12 leaving the implantable staple cartridge 30 and
staples 32 behind.
In applications wherein the end effector was inserted through a passage,
working channel, etc.
the surgeon will return the anvil 20 to the closed position by activating the
firing trigger 130 to
enable the end effector 12 to be withdrawn out through the passage or working
channel. If,
however, the surgeon desires to cut the target tissue after firing the
staples, the surgeon activates
the knife advancement trigger 200 in the above-described manner to drive the
knife bar 172
through the target tissue to the end of the end effector. Thereafter, the
surgeon may release the
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knife advancement trigger 200 to enable the firing return spring 202 to cause
the firing
transmission to return the knife bar 172 to the starting (un-actuated)
position. Once the knife bar
172 has been returned to the starting position, the surgeon may open the end
effector jaws 13, 15
to release the implantable cartridge 30 within the patient and then withdraw
the end effector 12
from the patient. Thus, such surgical instruments facilitate the use of small
implantable staple
cartridges that may be inserted through relatively smaller working channels
and passages, while
providing the surgeon with the option to fire the staples without cutting
tissue or if desired to
also cut tissue after the staples have been fired.
[0438] Various unique and novel embodiments of the present invention employ
a
compressible staple cartridge that supports staples in a substantially
stationary position for
forming contact by the anvil. In various embodiments, the anvil is driven into
the unformed
staples wherein, in at least one such embodiment, the degree of staple
formation attained is
dependent upon how far the anvil is driven into the staples. Such an
arrangement provides the
surgeon with the ability to adjust the amount of forming or firing pressure
applied to the staples
and thereby alter the final formed height of the staples. In other various
embodiments of the
present invention, surgical stapling arrangements can employ staple driving
elements which can
lift the staples toward the anvil. Such embodiments are described in greater
detail further below.
[0439] In various embodiments, with regard to the embodiments described in
detail above, the
amount of firing motion that is applied to the movable anvil is dependent upon
the degree of
actuation of the firing trigger. For example, if the surgeon desires to attain
only partially formed
staples, then the firing trigger is only partially depressed inward towards
the pistol grip 107. To
attain more staple formation, the surgeon simply compresses the firing trigger
further which
results in the anvil being further driven into forming contact with the
staples. As used herein, the
term "forming contact" means that the staple forming surface or staple forming
pockets have
contacted the ends of the staple legs and have started to form or bend the
legs over into a formed
position. The degree of staple formation refers to how far the staple legs
have been folded over
and ultimately relates to the forming height of the staple as referenced
above. Those of ordinary
skill in the art will further understand that, because the anvil 20 moves in a
substantially parallel
relationship with respect to the staple cartridge as the firing motions are
applied thereto, the
staples are formed substantially simultaneously with substantially the same
formed heights.
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[0440] FIGS. 2 and 3 illustrate an alternative end effector 12" that is
similar to the end effector
12' described above, except with the following differences that are configured
to accommodate a
knife bar 172'. The knife bar 172' is coupled to or protrudes from a knife rod
180 and is
otherwise operated in the above described manner with respect to the knife bar
172. However, in
this embodiment, the knife bar 172' is long enough to traverse the entire
length of the end
effector 12" and therefore, a separate distal knife member is not employed in
the end effector
12". The knife bar 172' has an upper transverse member 173' and a lower
transverse member
175' formed thereon. The upper transverse member 173' is oriented to slidably
transverse a
corresponding elongated slot 250 in anvil 20" and the lower transverse member
175' is oriented
to traverse an elongated slot 252 in the elongated channel 14" of the end
effector 12". A
disengagement slot (not shown) is also provide din the anvil 20" such that
when the knife bar
172' has been driven to an ending position with thin end effector 12", the
upper transverse
member 173' drops through the corresponding slot to enable the anvil 20" to
move to the open
position to disengage the stapled and cut tissue. The anvil 20" may be
otherwise identical to
anvil 20 described above and the elongated channel 14" may be otherwise
identical to elongated
channel 14 described above.
[0441] In these embodiments, the anvil 20" is biased to a fully open position
(FIG. 2) by a
spring or other opening arrangement (not shown). The anvil 20" is moved
between the open and
fully clamped positions by the axial travel of the firing adapter 150 in the
manner described
above. Once the firing adapter 150 has been advanced to the fully clamped
position (FIG. 3), the
surgeon may then advance the knife bar 172" distally in the manner described
above. If the
surgeon desires to use the end effector as a grasping device to manipulate
tissue, the firing
adapter may be moved proximally to allow the anvil 20" to move away from the
elongated
channel 14" as represented in FIG. 4 in broken lines. In this embodiment, as
the knife bar 172"
moves distally, the upper transverse member 173' and the lower transverse
member 175' draw
the anvil 20" and elongated channel 14" together to achieve the desired staple
formation as the
knife bar 172" is advanced distally through the end effector 12". See FIG. 5.
Thus, in this
embodiment, staple formation occurs simultaneously with tissue cutting, but
the staples
themselves may be sequentially formed as the knife bar 172" is driven
distally.
[0442] The unique and novel features of the various surgical staple cartridges
and the surgical
instruments of the present invention enable the staples in those cartridges to
be arranged in one
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or more linear or non-linear lines. A plurality of such staple lines may be
provided on each side
of an elongated slot that is centrally disposed within the staple cartridge
for receiving the tissue
cutting member therethrough. In one arrangement, for example, the staples in
one line may be
substantially parallel with the staples in adjacent line(s) of staples, but
offset therefrom. In still
other embodiments, one or more lines of staples may be non-linear in nature.
That is, the base of
at least one staple in a line of staples may extend along an axis that is
substantially transverse to
the bases of other staples in the same staple line. For example, as will be
discussed in further
detail below, in alternative embodiments, the lines of staples on each side of
the elongated slot
may have a zigzag appearance. Such non-linear staple arrangements may attain
better tissue
fastening results with less staples than various linear staple arrangements
employed in prior
staple cartridges.
[0443] FIG. 6 illustrates use of a surgical staple cartridge embodiment 900 in
an end effector
embodiment 612'. As can be seen in FIGS. 6 and 7, an embodiment of the
surgical staple
cartridge 900 has a cartridge body 902 that has a centrally disposed elongated
slot 904 extending
through a proximal end 903 to an area adjacent a distal end 905. The elongated
slot 904 is
configured to permit a knife body to axially move therethrough during a tissue
cutting operation
in the manner described above. In at least one embodiment, the cartridge body
902 consists of a
compressible hemostat material such as, for example, oxidized regenerated
cellulose ("ORC") or
a bio-absorbable foam fabricated from, for example, PGA (Polyglycolic acid,
sold under the
trademark Vicryl), PCL (polycaprolactone), PLA or PLLA (Polyactic acid), PDS,
(Polydioxanone), PHA (polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold
under the
trademark Monocryl) or a composite of PGA, PCL, PLA and PDS in which lines
920, 930 of
unformed staples 922 are supported. However, the cartridge body 902 may be
fabricated from
other materials that serve to support the unformed staples 922 in a desired
orientation such that
they may be compressed as the anvil 910' is brought into contact therewith. As
with various
other embodiments described above, the staple cartridge 900 is implantable and
is left attached to
the stapled tissue after the stapling procedure has been completed. In at
least some
embodiments, in order to prevent the staples 922 from being affected and the
hemostat material
from being activated during the introduction and positioning process, the
entire cartridge 900
may be coated or wrapped in a biodegradable film 906 such as a polydioxanon
film sold under
the trademark PDS or with a Polyglycerol sebacate (PGS) film or other
biodegradable films
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fabricated from, for example, PGA (Polyglycolic acid, marketed under the trade
mark Vicryl),
PCL (Polycaprolactonc), PLA or PLLA (Polylactic acid), PHA
(polyhydroxyalkanoate), PGCL
(poliglecaprone 25, sold under the trademark Monocryl) or a composite of PGA,
F'CL, PLA,
PDS that would be impermeable until ruptured. The cartridge body 902 of staple
cartridge 900 is
sized to be removably supported within the elongated channel of the end
effector 612'.
[0444] In the embodiment depicted in FIGS. 6, 10, and 11, the surgical staple
cartridge 900
operably supports a first line 920 of staples 922 on one lateral side 907 of
the elongated slot 904
and a second line 930 of staples 922 on the other lateral side 909 of the
elongated slot 904. In
various embodiments, the staples 922 may be fabricated from a metal material
such as, for
example, Titanium, Titanium alloys ( e.g., 6A1-4V Titanium, 3a1-2.5V
Titanium), Stainless Steel,
etc. and have a staple base 924 and two upstanding staple legs 926 protruding
therefrom. Each
staple leg 926 may have a tissue-piercing tip 928 formed thereon. In the first
line 920 of staples
922, the staple base 924 of at least one staple 922 overlaps the staple base
of another staple 922.
In a preferred embodiment, the staple base 924 of each staple 922 overlaps the
staple bases 924
of two adjacent staples 922, except for the base 924 of the last staple 922 on
each end of the first
staple line 920. See FIG. 10. Thus, the first staple line 920 has a
substantially non-linear shape.
More particularly, when viewed from above, the first staple line 920 has a
substantially zigzag
appearance.
[0445] As can be seen in FIG. 9, the anvil 90 has two sequential longitudinal
staple forming
pockets 912 that each has a substantial zigzag shape that corresponds to the
shape of the first line
920 of staples 922 such that, when the anvil 910 is brought into forming
contact with the staples
922, the legs 926 thereof are formed as shown in FIG. 11. Thus, the distal leg
of one staple
shares the same pocket as the proximal leg of the next staple longitudinally.
Such arrangement
allows for a denser pocket pattern, even to a point where the staples
themselves interact (e.g., are
folded over one another). In prior staple pocket arrangements, in general,
there has to be
between 0.005 and 0.015 inches of metal/space from one set of pockets to the
next. This
embodiment of the present invention, however, has a spacing arrangement from 0
to 0.02 inches
of interference/overlap (essentially a -0.020") because one staple mates with
the next staple, for
example. Such arrangements allow for 15-30% more staples in the same space.
Furthermore,
when the staples interlock, there is less need for multiple lateral rows of
staples. Prior
arrangements commonly employ three rows on each side of the tissue cut line to
prevent the
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existing of an open path through which blood may pass. Lines of interlocking
staples are less
likely to leave paths through which blood may pass. Another distinct advantage
provided by the
various interlocking staple arrangements of the present invention relates to
improved "burst
strength" which relates to the amount of force required to tear a staple line
open.
[0446] Another staple forming pocket arrangement may comprise a common staple
forming
pocket. As used herein, the term "common staple forming pocket" means that one
farming
pocket can form all of the staples in a single line of staples as opposed to
prior anvil designs
wherein a discrete forming pocket is provided for each leg of each staple to
be formed.
[0447] FIG. 12 illustrates yet another staple embodiment 922' wherein the base
924' has an
offset portion 929 to facilitate a tighter overlap of the bases 924'. As
indicated above, the staple
cartridge 900 has a second line 930 of staples 922 supported on a second
lateral side 909 of the
elongated slot 904. The second line 930 of staples 922 is substantially
identical to the first line
920 of staples 922. Thus, the anvil 910 has a second common staple forming
pocket 912 that
corresponds to the second line of staples 930 for forming contact therewith.
In alternative
embodiments, however, the second line 930 of staples 922 may differ from the
first line 920 of
staples in shape and, perhaps, number of staples.
[0448] FIG. 8 illustrates a surgical staple cartridge 900' that is
substantially identical to the
staple cartridge 900 described above, with the exception of the lines 920',
930' of staples 922
supported therein. For example, in this embodiment, the line 920' of staples
922 are arranged
relative to each other such that a base axis S-S of at least one staple base
924 is substantially
transverse to the base axis S-S of the staple base 924 of at least one other
adjacent staple 922.
Such predetermined pattern of staples, when viewed from above, comprises a
substantially
zigzag arrangement. In the embodiment depicted in FIG. 13, the respective
bases 924 of staples
922 may additionally have a base support member 927 overmolded thereon as
shown. In various
embodiments, the base support member 927 may be fabricated from, for example,
non-
absorbable plastic such as Polyether ether ketone "PEEK" or absorbable plastic
such as, for
example, Polyglycolic acid "PGA", Polylactic acid "PLA" or "PLLA",
Polydioxanone "PDS",
PCL (polycaprolactone), PHA (polyhydroxyalkanoate), PGCL (poliglecaprone 25,
sold under the
trademark Monocryl) or various composite mixes if PGS, PDS, PLA, PGA, and PCL.
The base
support members 927 facilitate interlocking between the staples without making
the staples
themselves overlap. Thus, such arrangements could form staples with "B" shapes
or inverted
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"W" shapes without the legs of the staples themselves overlapping. However,
the crowns are
connected by the base support members so they act like overlaping staples.
Such arrangements
allow the combined pockets to have two discrete paths for each leg.
[0449] The embodiment depicted in FIG. 14 employs a staple line 920" wherein
the legs 926 of
adjacent staples 922 are coupled together by a coupler portion 929 molded or
otherwise attached
thereto. Each coupler portion 929 may be fabricated from, for example,
Polyether ether ketone
"PEEK" or absorbable plastic such as, for example, Polyglycolic acid "PGA",
Polylactic acid
"PLA" or "PLLA", Polydioxanone "PDS", PCL (polycaprolactone), PHA
(polyhydroxyalkanoate), PGCL (poliglecaprone 25, sold under the trademark
Monocryl) or
various composite mixes if PGS, PDS, PLA, PGA, and PCL. Such staple line 920"
has
substantial zigzag appearance when viewed from above. While the various
surgical staple
cartridge embodiments 900, 900' have been explained with reference to use with
the end effector
612', it will be understood that the staple cartridges 900, 900' may be
effectively employed with
the various other end effectors and surgical instruments described
hereinabove, with appropriate
staple forming pocket arrangements being provided in the anvils of those
instruments in order to
achieved the desired amount of staple formation upon movement of the anvils
into forming
contact with the staples.
[0450] FIGS. 15 and 16 illustrate another surgical staple cartridge 940
embodiment supported
in an elongated channel 14 of a surgical instrument 10. In at least one
embodiment, the surgical
staple cartridge 940 includes a cartridge body 942 that has a centrally
disposed elongated slot
944 extending at least partially therethrough. The elongated slot 944 is
configured to permit a
knife body of the surgical instrument 10 to axially move therethrough during a
tissue cutting
operation in the manner described above. In various embodiments, the cartridge
body 942
consists of a compressible hemostat material such as, for example, oxidized
regenerated cellulose
("ORC") or a bio-absorbable foam of the types described above or below in
which lines 946,
948, 950, 952 of unformed staples 922 are supported. In at least some
embodiments, in order to
prevent the staples 922 from being affected and the hemostat material from
being activated
during the introduction and positioning process, the entire cartridge 940 may
be coated or
wrapped in a biodegradable film 954 such as a polydioxanon film sold under the
trademark
PDS or with a Polyglycerol sebacate (PGS) film or other biodegradable films
fabricated from,
for example, PGA (Polyglycolic acid, marketed under the trade mark Vicryl),
PCL
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(Polycaprolactone), PLA or PLLA (Polylactic acid), PHA (polyhydroxyalkanoate),
PGCL
(poliglecaprone 25, sold under the trademark Monocryl) or a composite of PGA,
PCL, PLA,
PDS that would be impermeable until ruptured.
[0451] In the embodiment depicted in FIG. 15, the cartridge 940 further
includes a cartridge
support member 960 that is coupled to the cartridge body 942. In various
embodiments, the
cartridge support member 960 may be fabricated from a rigid material such as,
for example,
Titanium, Stainless Steel, Aluminum, any alloy of the foregoing, etc. and may
be partially
embedded within the cartridge body 942. In various embodiments, the cartridge
support member
960 may be held in place by, for example, film 954. In still other embodiments
wherein a
limited bond is desired, sporadic use of cyanoacylate could be used to "glue"
the two
components together. In yet other embodiments, the cartridge body 942 may be
heated and
"welded" or "fused" to the cartridge support member 960. In various
embodiments, the cartridge
support member 960 forms at least a portion of the bottom surface of the
cartridge body 942 for
mating with the elongated channel 14. In at least one embodiment, the
cartridge support member
960 has one or more snap features 962 protruding therefrom for releasably
coupling the cartridge
support member 960 to the elongated channel 14. Other forms of snap
features/fastener
arrangements may be employed for releasably coupling the cartridge support
member 960 to the
elongated channel 14.
[0452] In various embodiments, the cartridge support member 960 has a series
of support
ridges 964, 966, 968, 970, 972, 974, 976 formed thereon to provide some
lateral support to the
bases 924 of the staples 922 in the staple lines 946, 948, 950, 952 as shown
in FIG. 15. Thus, in
at least some embodiments, the support ridges are substantially coextensive
with the staple lines.
FIG. 17 illustrates an alternative staple cartridge embodiment 940' that is
substantially identical
to cartridge 940, except for the inclusion of upstanding fin portions 978,
979, 980, 981, 982, 983
that protrude from the support ridges 964, 966, 968, 970, 972, 976,
respectively to provide
additional lateral support to the staples 922. In various embodiments, the fin
portions may be
integrally formed with the cartridge support member 960 and have a height that
is about 1/2 or
less of the height of the cartridge. Thus, in various embodiments, for
example, any standing
features supporting the foam cannot extend above the maximum compression
height of the foam.
Thus, if the cartridge is designed, for example, to compress to 1/3 of its
original height when
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fired, the fins would between 66% of the uncompressed height, all the way down
to 10% of
uncompressed height.
[0453] In use, once the staples 922 have been formed through contact with the
anvil 20 in the
manner described above, the anvil 20 is opened and the end effector 12 is
pulled away from the
stapled tissue. As the end effector 12 is pulled away from the stapled tissue,
the cartridge body
942 remains fastened to the stapled tissue and is then separated from the
cartridge support
member 960 which remains coupled to the elongated channel 14. In various
embodiments, the
cartridge support member 960 is provided with a color that differs from the
color of the material
comprising the cartridge body 942 as well as the color of the elongated
channel 14. Such
arrangement provides the surgeon with an easily recognizable indication that
no staple cartridge
is present within the end effector. Thus, the surgeon will not inadvertently
attempt to
reinsert/use the end effector without first installing a new staple cartridge
therein. To do so, the
surgeon simply disconnects the snap features of the cartridge support member
960 from the
elongated channel 14 to enable the cartridge support member 960 of a new
staple cartridge 940
to be placed therein. While the staple cartridges 940, 940' have been
explained with reference to
surgical instrument 10, it will be understood that those cartridges may be
effectively employed
with many of the other surgical instrument embodiments disclosed herein
without departing from
the spirit and scope of the present invention.
[0454] In various embodiments, a staple cartridge can comprise a cartridge
body and a plurality
of staples stored within the cartridge body. In use, the staple cartridge can
be introduced into a
surgical site and positioned on a side of the tissue being treated. In
addition, a staple-forming
anvil can be positioned on the opposite side of the tissue. In various
embodiments, the anvil can
be carried by a first jaw and the staple cartridge can be carried by a second
jaw, wherein the first
jaw and/or the second jaw can be moved toward the other. Once the staple
cartridge and the
anvil have been positioned relative to the tissue, the staples can be ejected
from the staple
cartridge body such that the staples can pierce the tissue and contact the
staple-forming anvil.
Once the staples have been deployed from the staple cartridge body, the staple
cartridge body
can then be removed from the surgical site. In various embodiments disclosed
herein, a staple
cartridge, or at least a portion of a staple cartridge, can be implanted with
the staples. In at least
one such embodiment, as described in greater detail further below, a staple
cartridge can
comprise a cartridge body which can be compressed, crushed, and/or collapsed
by the anvil when
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the anvil is moved from an open position into a closed position. When the
cartridge body is
compressed, crushed, and/or collapsed, the staples positioned within the
cartridge body can be
deformed by the anvil. Alternatively, the jaw supporting the staple cartridge
can be moved
toward the anvil into a closed position. In either event, in various
embodiments, the staples can
be deformed while they are at least partially positioned within the cartridge
body. In certain
embodiments, the staples may not be ejected from the staple cartridge while,
in some
embodiments, the staples can be ejected from the staple cartridge along with a
portion of the
cartridge body.
[0455] Referring now to FIGS. 18A-18D, a compressible staple cartridge, such
as staple
cartridge 1000, for example, can comprise a compressible, implantable
cartridge body 1010 and,
in addition, a plurality of staples 1020 positioned in the compressible
cartridge body 1010,
although only one staple 1020 is depicted in FIGS. 18A-18D. FIG. 18A
illustrates the staple
cartridge 1000 supported by a staple cartridge support, or staple cartridge
channel, 1030, wherein
the staple cartridge 1000 is illustrated in an uncompressed condition. In such
an uncompressed
condition, the anvil 1040 may or may not be in contact with the tissue T. In
use, the anvil 1040
can be moved from an open position into contact with the tissue T as
illustrated in FIG. 18B and
position the tissue T against the cartridge body 1010. Even though the anvil
1040 can position
the tissue T against a tissue-contacting surface 1019 of staple cartridge body
1010, referring
again to FIG. 18B, the staple cartridge body 1010 may be subjected to little,
if any, compressive
force or pressure at such point and the staples 1020 may remain in an
unformed, or unfired,
condition. As illustrated in FIGS. 18A and 18B, the staple cartridge body 1010
can comprise
one or more layers and the staple legs 1021 of staples 1020 can extend
upwardly through these
layers. In various embodiments, the cartridge body 1010 can comprise a first
layer 1011, a
second layer 1012, a third layer 1013, wherein the second layer 1012 can be
positioned
intermediate the first layer 1011 and the third layer 1013, and a fourth layer
1014, wherein the
third layer 1013 can be positioned intermediate the second layer 1012 and the
fourth layer 1014.
In at least one embodiment, the bases 1022 of the staples 1020 can be
positioned within cavities
1015 in the fourth layer 1014 and the staple legs 1021 can extend upwardly
from the bases 1022
and through the fourth layer 1014, the third layer 1013, and the second layer
1012, for example.
In various embodiments, each deformable leg 1021 can comprise a tip, such as
sharp tip 1023,
for example, which can be positioned in the second layer 1012, for example,
when the staple
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cartridge 1000 is in an uncompressed condition. In at least one such
embodiment, the tips 1023
may not extend into and/or through the first layer 1011, wherein, in at least
one embodiment, the
tips 1023 may not protrude through the tissue-contacting surface 1019 when the
staple cartridge
1000 is in an uncompressed condition. In certain other embodiments, the sharp
tips 1023 may be
positioned in the third layer 1013, and/or any other suitable layer, when the
staple cartridge is in
an uncompressed condition. In various alternative embodiments, a cartridge
body of a staple
cartridge may have any suitable number of layers such as less than four layers
or more than four
layers, for example.
[0456] In various embodiments, as described in greater detail below, the first
layer 1011 can be
comprised of a buttress material and/or plastic material, such as
polydioxanone (PDS) and/or
polyglycolic acid (PGA), for example, and the second layer 1012 can be
comprised of a
bioabsorbable foam material and/or a compressible hemostatic material, such as
oxidized
regenerated cellulose (ORC), for example. In various embodiments, one or more
of the first
layer 1011, the second layer 1012, the third layer 1013, and the fourth layer
1014 may hold the
staples 1020 within the staple cartridge body 1010 and, in addition, maintain
the staples 1020 in
alignment with one another. In various embodiments, the third layer 1013 can
be comprised of a
buttress material, or a fairly incompressible or inelastic material, which can
be configured to hold
the staple legs 1021 of the staples 1020 in position relative to one another.
Furthermore, the
second layer 1012 and the fourth layer 1014, which are positioned on opposite
sides of the third
layer 1013, can stabilize, or reduce the movement of, the staples 1020 even
though the second
layer 1012 and the fourth layer 1014 can be comprised of a compressible foam
or elastic
material. In certain embodiments, the staple tips 1023 of the staple legs 1021
can be at least
partially embedded in the first layer 1011. In at least one such embodiment,
the first layer 1011
and the third layer 1013 can be configured to co-operatively and firmly hold
the staple legs 1021
in position. In at least one embodiment, the first layer 1011 and the third
layer 1013 can each be
comprised of a sheet of bioabsorbable plastic, such as polyglycolic acid (PGA)
which is
marketed under the trade name Vicryl, polylactic acid (PLA or PLLA),
polydioxanone (PDS),
polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which is marketed under
the trade
name Monocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS,
PHA, PGCL
and/or PCL, for example, and the second layer 1012 and the fourth layer 1014
can each be
comprised of at least one hemostatic material or agent.
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[0457] Although the first layer 1011 can be compressible, the second layer
1012 can be
substantially more compressible than the first layer 1011. For example, the
second layer 1012
can be about twice as compressible, about three times as compressible, about
four times as
compressible, about five times as compressible, and/or about ten times as
compressible, for
example, as the first layer 1011. Stated another way, the second layer 1012
may compress about
two times, about three times, about four times, about five times, and/or about
ten times as much
as first layer 1011, for a given force. In certain embodiments, the second
layer 1012 can be
between about twice as compressible and about ten times as compressible, for
example, as the
first layer 1011. In at least one embodiment, the second layer 1012 can
comprise a plurality of
air voids defined therein, wherein the amount and/or size of the air voids in
the second layer
1012 can be controlled in order to provide a desired compressibility of the
second layer 1012.
Similar to the above, although the third layer 1013 can be compressible, the
fourth layer 1014
can be substantially more compressible than the third layer 1013. For example,
the fourth layer
1014 can be about twice as compressible, about three times as compressible,
about four times as
compressible, about five times as compressible, and/or about ten times as
compressible, for
example, as the third layer 1013. Stated another way, the fourth layer 1014
may compress about
two times, about three times, about four times, about five times, and/or about
ten times as much
as third layer 1013, for a given force. In certain embodiments, the fourth
layer 1014 can be
between about twice as compressible and about ten times as compressible, for
example, as the
third layer 1013. In at least one embodiment, the fourth layer 1014 can
comprise a plurality of
air voids defined therein, wherein the amount and/or size of the air voids in
the fourth layer 1014
can be controlled in order to provide a desired compressibility of the fourth
layer 1014. In
various circumstances, the compressibility of a cartridge body, or cartridge
body layer, can be
expressed in terms of a compression rate, i.e., a distance in which a layer is
compressed for a
given amount of force. For example, a layer having a high compression rate
will compress a
larger distance for a given amount of compressive force applied to the layer
as compared to a
layer having a lower compression rate. This being said, the second layer 1012
can have a higher
compression rate than the first layer 1011 and, similarly, the fourth layer
1014 can have a higher
compression rate than the third layer 1013. In various embodiments, the second
layer 1012 and
the fourth layer 1014 can be comprised of the same material and can comprise
the same
compression rate. In various embodiments, the second layer 1012 and the fourth
layer 1014 can
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be comprised of materials having different compression rates. Similarly, the
first layer 1011 and
the third layer 1013 can be comprised of the same material and can comprise
the same
compression rate. In certain embodiments, the first layer 1011 and the third
layer 1013 can be
comprised of materials having different compression rates.
[0458] As the anvil 1040 is moved toward its closed position, the anvil 1040
can contact tissue
T and apply a compressive force to the tissue T and the staple cartridge 1000,
as illustrated in
FIG. 18C. In such circumstances, the anvil 1040 can push the top surface, or
tissue-contacting
surface 1019, of the cartridge body 1010 downwardly toward the staple
cartridge support 1030.
In various embodiments, the staple cartridge support 1030 can comprise a
cartridge support
surface 1031 which can be configured to support the staple cartridge 1000 as
the staple cartridge
1000 is compressed between the cartridge support surface 1031 and the tissue-
contacting surface
1041 of anvil 1040. Owing to the pressure applied by the anvil 1040, the
cartridge body 1010
can be compressed and the anvil 1040 can come into contact with the staples
1020. More
particularly, in various embodiments, the compression of the cartridge body
1010 and the
downward movement of the tissue-contacting surface 1019 can cause the tips
1023 of the staple
legs 1021 to pierce the first layer 1011 of cartridge body 1010, pierce the
tissue T, and enter into
forming pockets 1042 in the anvil 1040. As the cartridge body 1010 is further
compressed by the
anvil 1040, the tips 1023 can contact the walls defining the forming pockets
1042 and, as a
result, the legs 1021 can be deformed or curled inwardly, for example, as
illustrated in FIG. 18C.
As the staple legs 1021 are being deformed, as also illustrated in FIG. 18C,
the bases 1022 of the
staples 1020 can be in contact with or supported by the staple cartridge
support 1030. In various
embodiments, as described in greater detail below, the staple cartridge
support 1030 can
comprise a plurality of support features, such as staple support grooves,
slots, or troughs 1032,
for example, which can be configured to support the staples 1020, or at least
the bases 1022 of
the staples 1020, as the staples 1020 are being deformed. As also illustrated
in FIG. 18C, the
cavities 1015 in the fourth layer 1014 can collapse as a result of the
compressive force applied to
the staple cartridge body 1010. In addition to the cavities 1015, the staple
cartridge body 1010
can further comprise one or more voids, such as voids 1016, for example, which
may or may not
comprise a portion of a staple positioned therein, that can be configured to
allow the cartridge
body 1010 to collapse. In various embodiments, the cavities 1015 and/or the
voids 1016 can be
configured to collapse such that the walls defining the cavities and/or walls
deflect downwardly
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and contact the cartridge support surface 1031 and/or contact a layer of the
cartridge body 1010
positioned underneath the cavities and/or voids.
[0459] Upon comparing FIG. 18B and FIG. 18C, it is evident that the second
layer 1012 and
the fourth layer 1014 have been substantially compressed by the compressive
pressure applied by
the anvil 1040. It may also be noted that the first layer 1011 and the third
layer 1013 have been
compressed as well. As the anvil 1040 is moved into its closed position, the
anvil 1040 may
continue to further compress the cartridge body 1010 by pushing the tissue-
contacting surface
1019 downwardly toward the staple cartridge support 1030 As the cartridge body
1010 is
further compressed, the anvil 1040 can deform the staples 1020 into their
completely-formed
shape as illustrated in FIG. 18D. Referring to FIG. 18D, the legs 1021 of each
staple 1020 can
be deformed downwardly toward the base 1022 of each staple 1020 in order to
capture at least a
portion of the tissue T, the first layer 1011, the second layer 1012, the
third layer 1013, and the
fourth layer 1014 between the deformable legs 1021 and the base 1022. Upon
comparing FIGS.
18C and 18D, it is further evident that the second layer 1012 and the fourth
layer 1014 have been
further substantially compressed by the compressive pressure applied by the
anvil 1040. It may
also be noted upon comparing FIGS. 18C and 18D that the first layer 1011 and
the third layer
1013 have been further compressed as well. After the staples 1020 have been
completely, or at
least sufficiently, formed, the anvil 1040 can be lifted away from the tissue
T and the staple
cartridge support 1030 can be moved away, and/or detached from, the staple
cartridge 1000. As
depicted in FIG. 18D, and as a result of the above, the cartridge body 1010
can be implanted
with the staples 1020. In various circumstances, the implanted cartridge body
1010 can support
the tissue along the staple line. In some circumstances, a hemostatic agent,
and/or any other
suitable therapeutic medicament, contained within the implanted cartridge body
1010 can treat
the tissue over time. A hemostatic agent, as mentioned above, can reduce the
bleeding of the
stapled and/or incised tissue while a bonding agent or tissue adhesive can
provide strength to the
tissue over time. The implanted cartridge body 1010 can be comprised of
materials such as ORC
(oxidized regenerated cellulous), protein matrix, polyglycolic acid (PGA)
which is marketed
under the trade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone
(PDS),
polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which is marketed under
the trade
name Monocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS,
PHA, PGCL
and/or PCL, for example. In certain circumstances, the cartridge body 1010 can
comprise an
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antibiotic and/or anti-microbial material, such as colloidal silver and/or
triclosan, for example,
which can reduce the possibility of infection in the surgical site.
[0460] In various embodiments, the layers of the cartridge body 1010 can be
connected to one
another. In at least one embodiment, the second layer 1012 can be adhered to
the first layer
1011, the third layer 1013 can be adhered to the second layer 1012, and the
fourth layer 1014 can
be adhered to the third layer 1013 utilizing at least one adhesive, such as
fibrin and/or protein
hydrogel, for example. In certain embodiments, although not illustrated, the
layers of the
cartridge body 1010 can be connected together by interlocking mechanical
features. In at least
one such embodiment, the first layer 1011 and the second layer 1012 can each
comprise
corresponding interlocking features, such as a tongue and groove arrangement
and/or a dovetail
joint arrangement, for example. Similarly, the second layer 1012 and the third
layer 1013 can
each comprise corresponding interlocking features while the third layer 1013
and the fourth layer
1014 can each comprise corresponding interlocking features. In certain
embodiments, although
not illustrated, the staple cartridge 1000 can comprise one or more rivets,
for example, which can
extend through one or more layers of the cartridge body 1010. In at least one
such embodiment,
each rivet can comprise a first end, or head, positioned adjacent to the first
layer 1011 and a
second head positioned adjacent to the fourth layer 1014 which can be either
assembled to or
formed by a second end of the rivet. Owing to the compressible nature of the
cartridge body
1010, in at least one embodiment, the rivets can compress the cartridge body
1010 such that the
heads of the rivets can be recessed relative to the tissue-contacting surface
1019 and/or the
bottom surface 1018 of the cartridge body 1010, for example. In at least one
such embodiment,
the rivets can be comprised of a bioabsorbable material, such as polyglycolic
acid (PGA) which
is marketed under the trade name Vicryl, polylactic acid (PLA or PLLA),
polydioxanone (PDS),
polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which is marketed under
the trade
name Monocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS,
PHA, PGCL
and/or PCL, for example. In certain embodiments, the layers of the cartridge
body 1010 may not
be connected to one another other than by the staples 1020 contained therein.
In at least one
such embodiment, the frictional engagement between the staple legs 1021 and
the cartridge body
1010, for example, can hold the layers of the cartridge body 1010 together
and, once the staples
have been formed, the layers can be captured within the staples 1020. In
certain embodiments, at
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least a portion of the staple legs 1021 can comprise a roughened surface or
rough coating which
can increase the friction forces between the staples 1020 and the cartridge
body 1010.
[0461] As described above, a surgical instrument can comprise a first jaw
including the staple
cartridge support 1030 and a second jaw including the anvil 1040. In various
embodiments, as
described in greater detail further below, the staple cartridge 1000 can
comprise one or more
retention features which can be configured to engage the staple cartridge
support 1030 and, as a
result, releasably retain the staple cartridge 1000 to the staple cartridge
support 1030. In certain
embodiments, the staple cartridge 1000 can be adhered to the staple cartridge
support 1030 by at
least one adhesive, such as fibrin and/or protein hydrogel, for example. In
use, in at least one
circumstance, especially in laparoscopic and/or endoscopic surgery, the second
jaw can be
moved into a closed position opposite the first jaw, for example, such that
the first and second
jaws can be inserted through a trocar into a surgical site. In at least one
such embodiment, the
trocar can define an approximately 5mm aperture, or cannula, through which the
first and second
jaws can be inserted. In certain embodiments, the second jaw can be moved into
a partially-
closed position intermediate the open position and the closed position which
can allow the first
and second jaws to be inserted through the trocar without deforming the
staples 1020 contained
in the staple cartridge body 1010. In at least one such embodiment, the anvil
1040 may not apply
a compressive force to the staple cartridge body 1010 when the second jaw is
in its partially-
closed intermediate position while, in certain other embodiments, the anvil
1040 can compress
the staple cartridge body 1010 when the second jaw is in its partially-closed
intermediate
position. Even though the anvil 1040 can compress the staple cartridge body
1010 when it is in
such an intermediate position, the anvil 1040 may not sufficiently compress
the staple cartridge
body 1010 such that the anvil 1040 comes into contact with the staples 1020
and/or such that the
staples 1020 are deformed by the anvil 1040. Once the first and second jaws
have been inserted
through the trocar into the surgical site, the second jaw can be opened once
again and the anvil
1040 and the staple cartridge 1000 can be positioned relative to the targeted
tissue as described
above.
[0462] In various embodiments, referring now to FIGS. 19A-19D, an end effector
of a surgical
stapler can comprise an implantable staple cartridge 1100 positioned
intermediate an anvil 1140
and a staple cartridge support 1130. Similar to the above, the anvil 1140 can
comprise a tissue-
contacting surface 1141, the staple cartridge 1100 can comprise a tissue-
contacting surface 1119,
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and the staple cartridge support 1130 can comprise a support surface 1131
which can be
configured to support the staple cartridge 1100. Referring to FIG. 19A, the
anvil 1140 can be
utilized to position the tissue T against the tissue contacting surface 1119
of staple cartridge 1100
without deforming the staple cartridge 1100 and, when the anvil 1140 is in
such a position, the
tissue-contacting surface 1141 can be positioned a distance 1101a away from
the staple cartridge
support surface 1131 and the tissue-contacting surface 1119 can be positioned
a distance 1102a
away from the staple cartridge support surface 1131. Thereafter, as the anvil
1140 is moved
toward the staple cartridge support 1130, referring now to FIG. 19B, the anvil
1140 can push the
top surface, or tissue-contacting surface 1119, of staple cartridge 1100
downwardly and
compress the first layer 1111 and the second layer 1112 of cartridge body
1110. As the layers
1111 and 1112 are compressed, referring again to FIG. 19B, the second layer
1112 can be
crushed and the legs 1121 of staples 1120 can pierce the first layer 1111 and
enter into the tissue
T. In at least one such embodiment, the staples 1120 can be at least partially
positioned within
staple cavities, or voids, 1115 in the second layer 1112 and, when the second
layer 1112 is
compressed, the staple cavities 1115 can collapse and, as a result, allow the
second layer 1112 to
collapse around the staples 1120. In various embodiments, the second layer
1112 can comprise
cover portions 1116 which can extend over the staple cavities 1115 and
enclose, or at least
partially enclose, the staple cavities 1115. FIG. 19B illustrates the cover
portions 1116 being
crushed downwardly into the staple cavities 1115. In certain embodiments, the
second layer
1112 can comprise one or more weakened portions which can facilitate the
collapse of the
second layer 1112. In various embodiments, such weakened portions can comprise
score marks,
perforations, and/or thin cross-sections, for example, which can facilitate a
controlled collapse of
the cartridge body 1110. In at least one embodiment, the first layer 1111 can
comprise one or
more weakened portions which can facilitate the penetration of the staple legs
1121 through the
first layer 1111. In various embodiments, such weakened portions can comprise
score marks,
perforations, and/or thin cross-sections, for example, which can be aligned,
or at least
substantially aligned, with the staple legs 1121.
[0463] When the anvil 1140 is in a partially closed, unfired position,
referring again to FIG.
19A, the anvil 1140 can be positioned a distance 1101a away from the cartridge
support surface
1131 such that a gap is defined therebetween. This gap can be filled by the
staple cartridge 1100,
having a staple cartridge height 1102a, and the tissue T. As the anvil 1140 is
moved downwardly
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to compress the staple cartridge 1100, referring again to FIG. 19B, the
distance between the
tissue contacting surface 1141 and the cartridge support surface 1131 can be
defined by a
distance 1101b which is shorter than the distance 1101a. In various
circumstances, the gap
between the tissue-contacting surface 1141 of anvil 1140 and the cartridge
support surface 1131,
defined by distance 1101b, may be larger than the original, undeformed staple
cartridge height
1102a. As the anvil 1140 is moved closer to the cartridge support surface
1131, referring now to
FIG. 19C, the second layer 1112 can continue to collapse and the distance
between the staple
legs 1121 and the forming pockets 1142 can decrease. Similarly, the distance
between the
tissue-contacting surface 1141 and the cartridge support surface 1131 can
decrease to a distance
1101c which, in various embodiments, may be greater than, equal to, or less
than the original,
undeformed cartridge height 1102a. Referring now to FIG. 19D, the anvil 1140
can be moved
into a final, fired position in which the staples 1120 have been fully formed,
or at least formed to
a desired height. In such a position, the tissue-contacting surface 1141 of
anvil 1140 can be a
distance 1101d away from the cartridge support surface 1131, wherein the
distance 1101d can be
shorter than the original, undeformed cartridge height 1102a. As also
illustrated in FIG. 19D, the
staple cavities 1115 may be fully, or at least substantially, collapsed and
the staples 1120 may be
completely, or at least substantially, surrounded by the collapsed second
layer 1112. In various
circumstances, the anvil 1140 can be thereafter moved away from the staple
cartridge 1100.
Once the anvil 1140 has been disengaged from the staple cartridge 1100, the
cartridge body 1110
can at least partially re-expand in various locations, i.e., locations
intermediate adjacent staples
1120, for example. In at least one embodiment, the crushed cartridge body 1110
may not
resiliently re-expand. In various embodiments, the formed staples 1120 and, in
addition, the
cartridge body 1110 positioned intermediate adjacent staples 1120 may apply
pressure, or
compressive forces, to the tissue T which may provide various therapeutic
benefits.
[0464] As discussed above, referring again to the embodiment illustrated in
FIG. 19A, each
staple 1120 can comprise staple legs 1121 extending therefrom. Although
staples 1120 are
depicted as comprising two staple legs 1121, various staples can be utilized
which can comprise
one staple leg or, alternatively, more than two staple legs, such as three
staple legs or four staple
legs, for example. As illustrated in FIG. 19A, each staple leg 1121 can be
embedded in the
second layer 1112 of the cartridge body 1110 such that the staples 1120 are
secured within the
second layer 1112. In various embodiments, the staples 1120 can be inserted
into the staple
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cavities 1115 in cartridge body 1110 such that the tips 1123 of the staple
legs 1121 enter into the
cavities 1115 before the bases 1122. After the tips 1123 have been inserted
into the cavities
1115, in various embodiments, the tips 1123 can be pressed into the cover
portions 1116 and
incise the second layer 1112. In various embodiments, the staples 1120 can be
seated to a
sufficient depth within the second layer 1112 such that the staples 1120 do
not move, or at least
substantially move, relative to the second layer 1112. In certain embodiments,
the staples 1120
can be seated to a sufficient depth within the second layer 1112 such that the
bases 1122 are
positioned or embedded within the staple cavities 1115. In various other
embodiments, the bases
1122 may not be positioned or embedded within the second layer 1112. In
certain embodiments,
referring again to FIG. 19A, the bases 1122 may extend below the bottom
surface 1118 of the
cartridge body 1110. In certain embodiments, the bases 1122 can rest on, or
can be directly
positioned against, the cartridge support surface 1130. In various
embodiments, the cartridge
support surface 1130 can comprise support features extending therefrom and/or
defined therein
wherein, in at least one such embodiment, the bases 1122 of the staples 1120
may be positioned
within and supported by one or more support grooves, slots, or troughs, 1132,
for example, in the
staple cartridge support 1130, as described in greater detail further below.
[0465] Further to the above, referring now to FIG. 20, the bases 1122 of the
staples 1120 can
be positioned directly against the support surface 1131 of staple cartridge
support 1130. In
various embodiments, including embodiments where the staple bases 1122
comprise circular or
arcuate bottom surfaces 1124, for example, the staple bases 1122 may move or
slide along the
staple cartridge support surface 1131. Such sliding can occur when the anvil
1140 is pressed
against the tips 1123 of the staple legs 1121 during the staple forming
process. In certain
embodiments, as described above and referring now to FIG. 21, the staple
cartridge support 1130
can comprise one or more support slots 1132 therein which can be configured to
eliminate, or at
least reduce, the relative movement between the staple bases 1122 and the
cartridge support
surface 1131. In at least one such embodiment, each support slot 1132 can be
defined by a
surface contour which matches, or at least substantially matches, the contour
of the bottom
surface of the staple positioned therein. For example, the bottom surface 1124
of the base 1122
depicted in FIG. 21 can comprise a circular, or at least substantially
circular, surface and the
support slot 1132 can also comprise a circular, or at least substantially
circular, surface. In at
least one such embodiment, the surface defining the slot 1132 can be defined
by a radius of
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curvature which is greater than or equal to a radius of curvature which
defines bottom surface
1124. Although the slots 1132 may assist in preventing or reducing relative
sliding movement
between the staples 1120 and the staple cartridge support 1130, the slots 1132
may also be
configured to prevent or reduce relative rotational movement between the
staples 1120 and the
staple cartridge support 1130. More particularly, in at least one embodiment,
the slots 1132 can
be configured to closely receive the bases 1122 in order to prevent or reduce
the rotation of the
staples 1120 about axes 1129, for example, such that the staples 1120 do not
rotate or twist when
they are being deformed.
[0466] In various embodiments, further to the above, each staple 1120 can be
formed from a
round, or an at least substantially round, wire. In certain embodiments, the
legs and the base of
each staple can be formed from a wire having a non-circular cross-section,
such as a rectangular
cross-section, for example. In at least one such embodiment, the staple
cartridge support 1130
can comprise corresponding non-circular slots, such as rectangular slots, for
example, configured
to receive the bases of such staples. In various embodiments, referring now to
FIG. 22, each
staple 1120 can comprise a crown, such as a crown 1125, for example,
overmolded onto a base
1122 wherein each crown 1125 can be positioned within a support slot in the
staple cartridge
support 1130. In at least one such embodiment, each crown 1125 can comprise a
square and/or
rectangular cross-section, for example, which can be configured to be received
within square
and/or rectangular slots 1134, for example, in the staple cartridge support
1130. In various
embodiments, the crowns 1125 can be comprised of a bioabsorbable plastic, such
as polyglycolic
acid (PGA) which is marketed under the trade name Vicryl, polylactic acid (PLA
or PLLA),
polydioxanone (PDS), polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL)
which is
marketed under the trade name Monocryl, polycaprolactone (PCL), and/or a
composite of PGA,
PLA, PDS, PHA, PGCL and/or PCL, for example, and can be formed around the
bases 1122 of
the staples 1120 by an injection molding process, for example. Various crowns
and methods for
forming various crowns are disclosed in U.S. Patent Application Serial No.
11/541,123, entitled
SURGICAL STAPLES HAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FOR
SECURING TISSUE THEREIN AND STAPLING INSTRUMENTS FOR DEPLOYING THE
SAME, filed on September 29, 2006, the entire disclosure of which is
incorporated be reference
herein. Referring again to FIG. 22, the slots 1134 can further comprise lead-
ins, or bevels, 1135
which can be configured to facilitate the insertion of the crowns 1125 into
the slots 1134. In
61
curvature which is greater than or equal to a radius of curvature which
defines bottom surface
1124. Although the slots 1132 may assist in preventing or reducing relative
sliding movement
between the staples 1120 and the staple cartridge support 1130, the slots 1132
may also be
configured to prevent or reduce relative rotational movement between the
staples 1120 and the
staple cartridge support 1130. More particularly, in at least one embodiment,
the slots 1132 can
be configured to closely receive the bases 1122 in order to prevent or reduce
the rotation of the
staples 1120 about axes 1129, for example, such that the staples 1120 do not
rotate or twist when
they are being deformed.
[0466] In various embodiments, further to the above, each staple 1120 can be
formed from a
round, or an at least substantially round, wire. In certain embodiments, the
legs and the base of
each staple can be formed from a wire having a non-circular cross-section,
such as a rectangular
cross-section, for example. In at least one such embodiment, the staple
cartridge support 1130
can comprise corresponding non-circular slots, such as rectangular slots, for
example, configured
to receive the bases of such staples. In various embodiments, referring now to
FIG. 22, each
staple 1120 can comprise a crown, such as a crown 1125, for example,
overmolded onto a base
1122 wherein each crown 1125 can be positioned within a support slot in the
staple cartridge
support 1130. In at least one such embodiment, each crown 1125 can comprise a
square and/or
rectangular cross-section, for example, which can be configured to be received
within square
and/or rectangular slots 1134, for example, in the staple cartridge support
1130. In various
embodiments, the crowns 1125 can be comprised of a bioabsorbable plastic, such
as polyglycolic
acid (PGA) which is marketed under the trade name Vicryl, polylactic acid (PLA
or PLLA),
polydioxanone (PDS), polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL)
which is
marketed under the trade name Monocryl, polycaprolactone (PCL), and/or a
composite of PGA.
PLA, PDS, PHA, PGCL and/or PCL, for example, and can be formed around the
bases 1122 of
the staples 1120 by an injection molding process, for example. Various crowns
and methods for
forming various crowns are disclosed in U.S. Patent Application Serial No.
11/541,123, now
U.S. Patent No. 7,794,475, entitled SURGICAL STAPLES HAVING COMPRESSIBLE OR
CRUSHABLE MEMBERS FOR SECURING TISSUE THEREIN AND STAPLING
INSTRUMENTS FOR DEPLOYING THE SAME, filed on September 29, 2006. Referring
again to FIG. 22, the slots 1134 can further comprise lead-ins, or bevels,
1135 which can be
configured to facilitate the insertion of the crowns 1125 into the slots 1134.
In
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the patient, for example. In various embodiments, referring again to FIGS. 23
and 24, the outer
layer 1211 can be comprised of a water impermeable, or at least substantially
water
impermeable, material such that liquids do not come into contact with, or at
least substantially
contact, the inner layer 1212 until after the cartridge body 1210 has been
compressed and the
staple legs have penetrated the outer layer 1211 and/or after the outer layer
1211 has been incised
in some fashion. In various embodiments, the outer layer 1211 can be comprised
of a buttress
material and/or plastic material, such as polydioxanone (PDS) and/or
polyglycolic acid (PGA),
for example. In certain embodiments, the outer layer 1211 can comprise a wrap
which surrounds
the inner layer 1212 and the staples 1220. More particularly, in at least one
embodiment, the
staples 1220 can be inserted into the inner layer 1212 and the outer layer
1211 can be wrapped
around the sub-assembly comprising the inner layer 1212 and the staples 1220
and then sealed.
[0468] In various embodiments, referring now to FIGS. 25 and 26, a staple
cartridge, such as
staple cartridge 1300, for example, can comprise a compressible, implantable
cartridge body
1310 including an outer layer 1311 and an inner layer 1312. Similar to the
above, the staple
cartridge 1300 can further comprise staples 1320 positioned within the
cartridge body 1310
wherein each staple 1320 can comprise a base 1322 and one or more legs 1321
extending
therefrom. Similar to staple cartridge 1200, the bases 1322 of staples 1320
can extend below the
bottom surface 1318 of the inner layer 1312 and the outer layer 1311 can
surround the bases
1322. In at least one such embodiment, the outer layer 1311 can be
sufficiently flexible so as to
envelop each staple base 1322 such that the outer layer 1311 conforms to the
contour of the
bases 1322. In at least one alternative embodiment, referring again to FIG.
24, the outer layer
1211 can be sufficiently rigid such that it extends around the bases 1222
without conforming to
each base 1222. In any event, in various embodiments, the outer layer 1311 can
be positioned
intermediate the bases 1322 of staples 1320 and a staple cartridge support
surface, such as
support surfaces 1031 or 1131, for example, supporting the staple cartridge
1300. In at least one
such embodiment, the outer layer 1311 can be positioned intermediate the bases
1322 and
support slots, such as slots 1032 or 1132, for example, defined in the staple
cartridge support
surface. In at least one such embodiment, further to the above, the outer
layer 1311 can be
configured to limit the movement of the bases 1322 and/or increase the
coefficient of friction
between the bases 1322 and the staple cartridge support surface and/or support
slots in order to
reduce relative movement therebetween. In various alternative embodiments,
referring now to
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FIGS. 27 and 28, the outer layer of a staple cartridge, such as staple
cartridge 1400, for example,
may not entirely surround the staples positioned therein. In at least one such
embodiment, an
outer layer 1411 of a compressible, implantable cartridge body 1410 may be
assembled to the
inner layer 1412 before the staple legs 1421 of staples 1420 are inserted into
the cartridge body
1410. As a result of the above, the bases 1422 of staples 1420 may extend
outside of the outer
layer 1411 and, in at least one such embodiment, the bases 1422 may be
positioned directly into
the support slots 1032 or 1132 within the staple cartridge support surfaces
1031 or 1131, for
example. In various embodiments, the staple legs 1421 may incise the outer
layer 1411 when
they are inserted therethrough. In various circumstances, the holes created by
the staple legs
1421 may closely surround the staple legs 1421 such that very little, if any,
fluid can leak
between the staple legs 1421 and the outer layer 1411 which can reduce the
possibility of, or
prevent, the medicament contained within the staple cartridge body 1410 from
being activated
and/or leaking out of the cartridge body 1410 prematurely.
[0469] As discussed above, referring again to FIGS. 23 and 24, the legs 1221
of the staples
1220 can be embedded within the cartridge body 1210 and the bases 1222 of
staples 1220 may
extend outwardly from the bottom surface 1218 of the inner layer 1212. In
various
embodiments, further to the above, the inner layer 1212 may not comprise
staple cavities
configured to receive the staples 1220. In various other embodiments,
referring now to FIGS. 29
and 30, a staple cartridge, such as staple cartridge 1500, for example, may
comprise a
compressible, implantable cartridge body 1510 comprising staple cavities 1515
which can be
configured to receive at least a portion of the staples 1520 therein. In at
least one such
embodiment, a top portion of the staple legs 1521 of the staples 1520 may be
embedded in the
inner layer 1512 while a bottom portion of the staple legs 1521, and the bases
1522, may be
positioned within the staple cavities 1515. In certain embodiments, the bases
1522 may be
entirely positioned in the staple cavities 1515 while, in some embodiments,
the bases 1522 may
at least partially extend below the bottom surface 1518 of the inner layer
1512. Similar to the
above, the outer layer 1511 may enclose the inner layer 1512 and the staples
1520 positioned
therein. In certain other embodiments, referring now to FIG. 31, a staple
cartridge 1600 may
comprise staples 1620 positioned within staple cavities 1615 in a
compressible, implantable
cartridge body 1610 wherein at least a portion of the staples 1620 are not
enclosed by the outer
layer 1611. In at least one such embodiment, each staple 1620 can comprise
staple legs 1621
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which are at least partially embedded in the inner layer 1612 and, in
addition, bases 1622 which
extend outwardly around the outer layer 1611.
[0470] In various embodiments, referring now to FIGS. 32 and 33, a staple
cartridge, such as
staple cartridge 1700, for example, can comprise a compressible, implantable
cartridge body
1710 and a plurality of staples 1720 at least partially positioned within the
cartridge body 1710.
The cartridge body 1710 can comprise an outer layer 1711, an inner layer 1712,
and, in addition,
an alignment matrix 1740 which can be configured to align and/or retain the
staples 1720 in
position within the cartridge body 1710 In at least one embodiment, the inner
layer 1712 can
comprise a recess 1741 which can be configured to receive the alignment matrix
1740 therein.
In various embodiments, the alignment matrix 1140 can be press-fit within the
recess 1741
and/or otherwise suitably secured to the inner layer 1712 utilizing at least
one adhesive, such as
fibrin and/or protein hydrogel, for example. In at least one embodiment, the
recess 1741 can be
configured such that the bottom surface 1742 of alignment matrix 1740 is
aligned, or at least
substantially aligned, with the bottom surface 1718 of the inner layer 1712.
In certain
embodiments, the bottom surface 1742 of the alignment matrix can be recessed
with respect to
and/or extend from the bottom surface 1718 of the second layer 1712. In
various embodiments,
each staple 1720 can comprise a base 1722 and one or more legs 1721 extending
from the base
1722, wherein at least a portion of the staple legs 1721 can extend through
the alignment matrix
1740. The alignment matrix 1740 can further comprise a plurality of apertures
and/or slots, for
example, extending therethrough which can be configured to receive the staple
legs 1721 therein.
In at least one such embodiment, each aperture can be configured to closely
receive a staple leg
1721 such that there is little, if any, relative movement between the staple
leg 1721 and the
sidewalls of the aperture. In certain embodiments, the alignment matrix
apertures may not
extend entirely through the alignment matrix 1740 and the staple legs 1721 may
be required to
incise the alignment matrix 1740 as the staple legs 1721 are pushed
therethrough.
[0471] In various embodiments, the alignment matrix 1740 can be comprised of a
molded
plastic body which, in at least one embodiment, can be stiffer or less
compressible than the inner
layer 1712 and/or the outer layer 1711. In at least one such embodiment, the
alignment matrix
1740 can be comprised of a plastic material and/or any other suitable
material, such as
polydioxanone (PDS) and/or polyglycolic acid (PGA), for example. In certain
embodiments, the
alignment matrix 1740 can be assembled to the inner layer 1712 and the staple
legs 1721 can
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thereafter be inserted through the alignment matrix 1740 and embedded into the
inner layer
1712. In various embodiments, the bottom surface 1742 of the alignment matrix
1740 can
comprise one or more grooves, slots, or troughs, for example, which can be
configured to at least
partially receive the bases 1722 of the staples 1720. Similar to the above,
the outer layer 1711
can then be placed around the subassembly comprising the inner layer 1712, the
alignment
matrix 1740, and the staples 1720. Alternatively, the outer layer 1711 can be
placed around a
subassembly comprising the inner layer 1712 and the alignment matrix 1740
wherein the staples
1720 can be thereafter inserted through the outer layer 1711, the alignment
matrix 1740, and the
inner layer 1712. In any event, as a result of the above, the inner layer
1712, the alignment
matrix 1740, and/or the outer layer 1711 can be configured to retain the
staples 1720 in position
until and/or after they are deformed by an anvil as described above. In at
least one such
embodiment, the alignment matrix 1740 can serve to hold the staples 1720 in
place before the
staple cartridge 1700 is implanted within a patient and, in addition, secure
the tissue along the
staple line after the staple cartridge 1700 has been implanted. In at least
one embodiment, the
staples 1720 may be secured within the alignment matrix 1740 without being
embedded in the
inner layer 1712 and/or the outer layer 1711, for example.
[0472] In various embodiments, referring now to FIGS. 34-40, a staple
cartridge, such as staple
cartridge 1800, for example, can be assembled by compressing an inner layer
1812, inserting
staples, such as staples 1820, for example, into the inner layer 1812, and
wrapping the inner layer
1812 with an outer layer 1811. Referring primarily to FIG. 34, a compressible
inner layer 1812
is illustrated as comprising a plurality of staple cavities 1815 defined
therein, although other
embodiments are envisioned in which the inner layer 1812 does not comprise
staple cavities, as
described above. Referring now to FIG. 35, the compressible inner layer 1812
can be positioned
intermediate a transfer plate 1850 and a support plate 1860 and compressed
between the
compression surfaces 1852 and 1862 thereof, respectively. As illustrated in
FIG. 35, the top and
bottom surfaces of the inner layer 1812 can be compressed toward one another
and, in response
thereto, the inner layer 1812 can bulge outwardly in the lateral directions.
In certain
embodiments, the inner layer 1812 can be compressed to a height which is
approximately one-
third of its original height, for example, and can have a height or thickness
between
approximately 0.06" and approximately 0.08" in its compressed state, for
example. As also
illustrated in FIG. 35, the transfer plate 1850 can further comprise a
plurality of staples, such as
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staples 1820, for example, positioned within a plurality of staple wells 1853.
In addition, the
transfer plate 1850 can further comprise a plurality of drivers 1851 which can
be configured to
push the staples 1820 upwardly and out of the staple wells 1853. Referring now
to FIG. 36, the
drivers 1851 can be utilized to push the staple legs 1821 of the staples 1820
into and through the
compressed inner layer 1812. In various embodiments, the drivers 1851 can be
configured such
that the top surfaces thereof are positioned flush, or at least nearly flush,
with the compression
surface 1852 of the transfer plate 1850 when the staples 1820 have been fully
deployed from the
staple wells 1853 of transfer plate 1850 In certain embodiments, as also
illustrated in FIG 36,
the support plate 1860 can comprise a plurality of receiving apertures 1861
which can be
configured to receive the staple legs 1821, or at least the tips of the staple
legs 1821, after they
are pushed through the inner layer 1812. The receiving apertures 1861, or the
like, may be
necessitated in embodiments where the inner layer 1812 has been compressed to
a height which
is shorter than the height of the staples 1820 and, thus, when the staples
1820 have been fully
ejected from the staple wells 1853, the staple legs 1821 may protrude from the
top surface of the
compressed inner layer 1812. In certain other embodiments, the inner layer
1812 may be
compressed to a height which is taller than the height of the staples 1820
and, as a result, the
receiving apertures 1861 in support plate 1860 may be unnecessary.
[0473] After the staples 1820 have been inserted into the inner layer 1812,
referring now to
FIG. 37, the support plate 1860 can be moved away from the transfer plate 1850
in order to allow
the inner layer 1812 to decompress. In such circumstances, the inner layer
1812 can resiliently
re-expand to its original, or at least near-original, uncompressed height. As
the inner layer 1812
re-expands, the height of the inner layer 1812 can increase such that it
exceeds the height of the
staples 1820 and such that the staple legs 1821 of the staples 1820 no longer
protrude from the
top surface of the inner layer 1812. In various circumstances, the receiving
apertures 1861 can
be configured to hold the staple legs 1821 in position at least until the
support plate 1860 has
been sufficiently moved away such that the legs 1821 are no longer positioned
within the
receiving apertures 1861. In such circumstances, the receiving apertures 1861
can assist in
maintaining the relative alignment of the staples 1820 within the inner layer
1812 as it re-
expands. In various circumstances, the inner layer 1812 and the staples 1820
positioned therein
can comprise a subassembly 1801 which, referring now to FIG. 38, can be
inserted into an outer
layer 1811, for example. In at least one such embodiment, the outer layer 1811
can comprise a
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cavity 1802 defined therein which can be configured to receive the subassembly
1801 therein. In
various circumstances, a tool, such as pliers 1855, for example, can be
utilized to pull the outer
layer 1811 onto the subassembly 1801. Once the subassembly 1801 has been
sufficiently
positioned within the outer layer 1811, referring now to FIG. 39, the outer
layer 1811 can be
sealed. In various embodiments, the outer layer 1811 can be sealed utilizing
the application of
heat energy to a portion thereof. More particularly, in at least one
embodiment, the outer layer
1811 can be comprised of a plastic material wherein the open end of the outer
layer 1811 can be
heat-staked by one or more heated elements, or irons, 1856 in order to bond
and/or seal the
perimeter of the open end of the outer layer 1811 together. In at least one
such embodiment,
referring now to FIG. 40, an excess portion 1857 of the outer layer 1811 can
be removed and the
staple cartridge 1800 can then be used as described herein.
[0474] As described above, a staple cartridge can be positioned within and/or
secured to a
staple cartridge attachment portion. In various embodiments, referring now to
FIGS. 41 and 42,
a staple cartridge attachment portion can comprise a staple cartridge channel,
such as staple
cartridge channel 1930, for example, which can be configured to receive at
least a portion of a
staple cartridge, such as staple cartridge 1900, for example, therein. In at
least one embodiment,
the staple cartridge channel 1930 can comprise a bottom support surface 1931,
a first lateral
support wall 1940, and a second lateral support wall 1941. In use, the staple
cartridge 1900 can
be positioned within the staple cartridge channel 1930 such that the staple
cartridge 1900 is
positioned against and/or adjacent to the bottom support surface 1931 and
positioned
intermediate the first lateral support wall 1940 and the second lateral
support wall 1941. In
certain embodiments, the first lateral support wall 1940 and the second
lateral support wall 1941
can define a lateral gap therebetween. In at least one such embodiment, the
staple cartridge 1900
can comprise a lateral width 1903 which is the same as and/or wider than the
lateral gap defined
between the support walls 1940 and 1941 such that a compressible, implantable
cartridge body
1910 of the staple cartridge 1900 can fit securely between the walls 1940 and
1941. In certain
other embodiments, the lateral width 1903 of the staple cartridge 1900 can be
shorter than the
gap defined between the first and second side walls 1940 and 1941. In various
embodiments, at
least a portion of the walls 1940 and 1941 and the bottom support surface 1931
can be defined by
a stamped metal channel while, in at least one embodiment, at least a portion
of the lateral
support wall 1940 and/or lateral support wall 1941 can be comprised of a
flexible material, such
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as an elastomeric material, for example. Referring primarily to FIG. 41, the
first side wall 1940
and the second side wall 1941 of the staple cartridge channel 1930 can each be
comprised of a
rigid portion 1933 extending upwardly from the bottom support surface 1931 and
a flexible
portion 1934 extending upwardly from the rigid portions 1933.
[0475] In various embodiments, further to the above, the cartridge body 1910
of staple
cartridge 1900 can be comprised of one or more compressible layers, such as
first layer 1911 and
second layer 1912, for example. When the cartridge body 1910 is compressed
against the
bottom support surface 1931 by an anvil, as described above, the side portions
of the cartridge
body 1910 can expand laterally. In embodiments where the staple cartridge 1930
is comprised of
rigid side walls, the lateral expansion of the cartridge body 1910 can be
prevented, or at least
limited, by the rigid side walls and, as a result, a significant amount of
internal pressure, or
stress, can be developed within the cartridge body 1910. In embodiments where
at least a
portion of the staple cartridge 1930 is comprised of flexible side walls, the
flexible side walls can
be configured to flex laterally and permit the side portions of the cartridge
body 1910 to expand
laterally, thereby reducing the internal pressure, or stress, generated within
the cartridge body
1910. In embodiments where the cartridge channel does not comprise lateral
side walls, or
comprises lateral sidewalls which are relatively shorter than the staple
cartridge, the side portions
of the staple cartridge may expand laterally uninhibited, or at least
substantially uninhibited. In
any event, referring now to FIG. 42, a staple cartridge channel 2030 can
comprise lateral
sidewalls 2040 and 2041 which can be entirely comprised of a flexible
material, such as an
elastomeric material, for example. The staple cartridge channel 2030 can
further comprise
lateral slots 2033 extending along the sides of the bottom support surface
2031 of the staple
cartridge channel 2030 which can be configured to receive and secure at least
a portion of the
lateral sidewalls 2040 and 2041 therein. In certain embodiments, the lateral
side walls 2040 and
2041 can be secured in the slots 2033 via a snap-fit and/or press-fit
arrangement while, in at least
some embodiments, the lateral side walls 2040 and 2041 can be secured in the
slots 2033 by one
or more adhesives. In at least one embodiment, the sidewalls 2040 and 2041 may
be detachable
from the bottom support surface 2031 during use. In any event, a compressible,
implantable
cartridge body 2010 can be detached and/or disengaged from the lateral side
walls 2040 and
2041 when the cartridge body 2010 is implanted with the staples 2020.
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[0476] In various embodiments, referring now to FIG. 43, a surgical instrument
can comprise a
shaft 2150 and an end effector extending from the distal end of the shaft
2150. The end effector
can comprise, similar to the above, a staple cartridge channel 2130, an anvil
2140 movable
between an open position and a closed position, and a staple cartridge 2100
positioned
intermediate the staple cartridge channel 2130 and the anvil 2140. Also
similar to the above, the
staple cartridge 2100 can comprise a compressible, implantable cartridge body
2110 and a
plurality of staples 2120 positioned in the cartridge body 2110. In various
embodiments, the
staple cartridge channel 2130 can comprise, one, a bottom support surface 2131
against which
the staple cartridge 2100 can be positioned, two, a distal end 2135 and,
three, a proximal end
2136. In at least one embodiment, as illustrated in FIG. 43, the staple
cartridge 2100 can
comprise a first end 2105 which can be positionable in the distal end 2135 of
the staple cartridge
channel 2130 and a second end 2106 which can be positionable in the proximal
end 2136 of the
staple cartridge channel 2130. In various embodiments, the distal end 2135 of
the staple
cartridge channel 2130 can comprise at least one distal retention feature,
such as a retention wall
2137, for example, and, similarly, the proximal end 2136 can comprise at least
one proximal
retention feature, such as a retention wall 2138, for example. In at least one
such embodiment,
the distal retention wall 2137 and the proximal retention wall 2138 can define
a gap
therebetween which can be equal to or less than the length of the staple
cartridge 2100 such that
the staple cartridge 2100 can fit securely within the staple cartridge channel
2130 when the staple
cartridge 2100 is inserted therein.
[0477] In various embodiments, referring again to FIGS. 23 and 24, a staple
cartridge, such as
staple cartridge 1200, for example, can comprise a flat, or at least
substantially flat, tissue-
contacting surface 1219. In at least one such embodiment, the staple cartridge
body 1210 of
staple cartridge 1200 can comprise a first end 1205 which can be defined by a
first height, or
thickness, 1207 and a second end 1206 which can be defined by a second height,
or thickness,
1208, wherein the first height 1207 can be equal to, or at least substantially
equal to, the second
height 1208. In certain embodiments, the cartridge body 1210 can comprise a
constant, or at
least substantially constant, height, or thickness, between the first end 1205
and the second end
1206. In at least one such embodiment, the tissue-contacting surface 1219 can
be parallel, or at
least substantially parallel, to the bottom surface 1218 of the cartridge body
1210. In various
embodiments, referring once again to FIG. 43, the first end 2105 of the
cartridge body 2110 of
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staple cartridge 2100 can be defined by a first height 2107 which is different
than a second
height 2108 of the second end 2106. In the illustrated embodiment, the first
height 2107 is larger
than the second height 2108, although the second height 2108 could be larger
than the first
height 2107 in alternative embodiments. In various embodiments, the height of
the cartridge
body 2110 can decrease linearly and/or geometrically between the first end
2105 and the second
end 2106. In at least one such embodiment, the tissue-contacting surface 2119,
which extends
between the first end 2105 and the second end 2106, can be oriented along an
angle defined
therebetween. In at least one such embodiment, the tissue-contacting surface
2119 may not be
parallel to the bottom surface 2118 of the cartridge body 2110 and/or parallel
to the support
surface 2131 of the staple cartridge channel 2130.
[0478] In various embodiments, referring again to FIGS. 43 and 44, the anvil
2140 can
comprise a tissue-contacting surface 2141 which can be parallel, or at least
substantially parallel,
to the support surface 2131 of the staple cartridge channel 2130 when the
anvil 2140 is in a
closed position, as illustrated in FIG. 44. When the anvil 2140 is in a closed
position, the anvil
2140 can be configured to compress the first end 2105 of the staple cartridge
2100 more than the
second end 2106 owing to the taller height of the first end 2105 and the
shorter height of the
second end 2106. In some circumstances, including circumstances where the
tissue T positioned
intermediate the tissue contacting surfaces 2119 and 2141 has a constant, or
at least substantially
constant, thickness, the pressure generated within the tissue T and the
cartridge 2100 can be
greater at the distal end of the end effector than the proximal end of the end
effector. More
particularly, when the tissue T between the anvil 2140 and the staple
cartridge 2100 has a
substantially constant thickness, the tissue T positioned intermediate the
distal end 2145 of the
anvil 2140 and the first end 2105 of the staple cartridge 2100 can be more
compressed than the
tissue T positioned intermediate the proximal end 2146 of the anvil 2140 and
the second end
2106 of the staple cartridge 2100. In various embodiments, a pressure gradient
can be generated
within the tissue T between the proximal end and the distal end of the end
effector. More
particularly, in at least one embodiment, when the tissue T between the anvil
2140 and the staple
cartridge 2100 has a substantially constant thickness and the height of the
staple cartridge 2100
decreases linearly from the distal end to the proximal end of the end
effector, the pressure within
the tissue T can decrease linearly from the distal end of the end effector to
the proximal end of
the end effector. Similarly, in at least one embodiment, when the tissue T
between the anvil
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2140 and the staple cartridge 2100 has a substantially constant thickness and
the height of the
staple cartridge 2100 decreases geometrically from the distal end to the
proximal end of the end
effector, the pressure within the tissue T can decrease geometrically from the
distal end of the
end effector to the proximal end of the end effector.
[0479] In various embodiments, referring again to FIG. 43, the tissue T
positioned intermediate
the staple cartridge 2100 and the anvil 2140 may not have a constant thickness
throughout. In at
least one such circumstance, the tissue T positioned between the proximal end
2146 of the anvil
2140 and the second end 2106 of the staple cartridge 2100 may be thicker than
the tissue T
positioned between the distal end 2145 of the anvil 2140 and the first end
2105 of the staple
cartridge 2100. In such circumstances, as a result, the thicker tissue T may
be generally
positioned above the shorter proximal end 2106 of the staple cartridge 2100
and the thinner
tissue T may be generally positioned above the taller distal end 2105. In use,
the firing collar
2152 of the shaft 2150 can be advanced distally along the shaft spine 2151
such that the firing
collar 2152 engages the cam portion 2143 of the anvil 2140 and rotates the
anvil 2140 toward the
staple cartridge 2100 as illustrated in FIG. 44. Once the anvil 2140 has been
rotated into a fully-
closed position, the tissue T may be compressed between the tissue-contacting
surfaces 2119 and
2141 and, even though the height of the staple cartridge 2100 may not be
constant between the
proximal and distal ends of the end effector, the pressure or compressive
forces applied to the
tissue T may be constant, or at least substantially constant, thereacross.
More particularly, as the
thinner tissue T may be associated with the taller height of the staple
cartridge 2100 and the
thicker tissue T may be associated with the shorter height of the staple
cartridge 2100, the
cumulative, or summed, height of the tissue T and the staple cartridge 2100
may be constant, or
at least substantially constant, between the proximal and distal ends of the
end effector and, as a
result, the compression of this cumulative height by the anvil 2140 may be
constant, or at least
substantially constant, thereacross.
[0480] In various embodiments, referring again to FIGS. 43 and 44, the staple
cartridge 2100
can comprise an asymmetrical configuration. In at least one such embodiment,
for example, the
height of the staple cartridge 2100 at the first end 2105 thereof may be
higher than the height of
the staple cartridge 2100 at the second end 2106 thereof. In certain
embodiments, the staple
cartridge 2100 and/or the staple cartridge channel 2130 can comprise one or
more alignment
and/or retention features which can be configured to assure that the staple
cartridge 2100 can
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only be positioned within the staple cartridge channel 2130 in one
orientation, i.e., an orientation
in which the first end 2105 is positioned in the distal end 2135 of the staple
cartridge channel
2130 and the second end 2106 is positioned in the proximal end 2136. In
various alternative
embodiments, the staple cartridge 2100 and/or the staple cartridge channel
2130 can comprise
one or more alignment and/or retention features which can be configured to
permit the staple
cartridge 2100 to be positioned within the staple cartridge channel 2130 in
more than one
orientation. Referring now to FIG. 45, for example, the staple cartridge 2100
can be positioned
within the staple cartridge channel 2130 such that the first end 2105 of the
staple cartridge 2100
can be positioned in the proximal end 2136 of the staple cartridge channel
2130 and the second
end 2106 can be positioned in the distal end 2135. In various embodiments, as
a result, the
shorter height of the staple cartridge 2100 can be positioned proximate the
distal retention wall
2137 and the taller height of the staple cartridge 2100 can be positioned
proximate to the
proximal retention wall 2138. In at least one such embodiment, the staple
cartridge 2100 can be
suitably arranged to apply a constant, or at least substantially constant,
clamping pressure to
tissue T having a thicker portion within the distal end of the end effector
and a thinner portion
within the proximal end of the end effector. In various embodiments, the
staple cartridge 2100,
for example, can be selectively oriented within the staple cartridge channel
2130. In at least one
such embodiment, the alignment and/or retention features of the staple
cartridge 2100 can be
symmetrical and a surgeon can selectively orient the staple cartridge 2100
within the staple
cartridge channel 2130 in the orientations depicted in FIG. 43 and FIG. 45,
for example.
[0481] Further to the above, the implantable cartridge body 2110 can comprise
a longitudinal
axis 2109 which, when the staple cartridge 2100 is positioned in the staple
cartridge channel
2130, can extend between the proximal and distal ends of the end effector. In
various
embodiments, the thickness of the cartridge body 2110 can generally decrease
and/or generally
increase between the first end 2105 and the second end 2106 along the
longitudinal axis 2109. In
at least one such embodiment, the distance, or height, between the bottom
surface 2118 and the
tissue-contacting surface 2119 can generally decrease and/or generally
increase between the first
end 2105 and the second end 2106. In certain embodiments, the thickness of the
cartridge body
2110 can both increase and decrease along the longitudinal axis 2109. In at
least one such
embodiment, the thickness of the cartridge body 2110 can comprise one or more
portions which
increase in thickness and one or more portions which can decrease in
thickness. In various
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embodiments, the staple cartridge 2100 can comprise a plurality of staples
2120 positioned
therein. In use, as described above, the staples 2120 can be deformed when the
anvil 2140 is
moved into a closed position. In certain embodiments, each staple 2120 can
have the same, or at
least substantially the same, height. In at least one such embodiment, the
height of a staple can
be measured from the bottom of the base of the staple to the top, or tip, of
the tallest leg of the
staple, for example.
[0482] In various embodiments, the staples within a staple cartridge can have
different staple
heights. In at least one such embodiment, a staple cartridge can comprise a
first group of staples
having a first staple height which are positioned in a first portion of a
compressible cartridge
body and a second group of staples having a second staple height which are
positioned in a
second portion of the compressible cartridge body. In at least one embodiment,
the first staple
height can be taller than the second staple height and the first group of
staples can be positioned
in the first end 2105 of the staple cartridge 2100 while the second group of
staples can be
positioned in the second end 2106. Alternatively, the taller first group of
staples can be
positioned in the second end 2106 of the staple cartridge 2100 while the
shorter second group of
staples can be positioned in the first end 2105. In certain embodiments, a
plurality of staple
groups, each group having a different staple height, can be utilized. In at
least one such
embodiment, a third group having an intermediate staple height can be
positioned in the cartridge
body 2110 intermediate the first group of staples and the second group of
staples. In various
embodiments, each staple within a staple row in the staple cartridge can
comprise a different
staple height. In at least one embodiment, the tallest staple within a staple
row can be positioned
on a first end of a staple row and the shortest staple can be positioned on an
opposite end of the
staple row. In at least one such embodiment, the staples positioned
intermediate the tallest staple
and the shortest staple can be arranged such that the staple heights descend
between the tallest
staple and the shortest staple, for example.
[0483] In various embodiments, referring now to FIG. 46, an end effector of a
surgical stapler
can comprise an anvil 2240, a staple cartridge channel 2230, and a staple
cartridge 2200
supported by the staple cartridge channel 2230. The staple cartridge 2200 can
comprise a
compressible, implantable cartridge body 2210 and a plurality of staples, such
as staples 2220a
and staples 2220b, for example, positioned therein. In various embodiments,
the staple cartridge
channel 2230 can comprise a cartridge support surface 2231 and a plurality of
staple support
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slots, such as support slots 2232a and 2232b, for example, defined therein. In
at least one such
embodiment, the staple cartridge 2200 can comprise two outer rows of staples
2220a and two
inner rows of staples 2220b, wherein the support slots 2232a can be configured
to support the
staples 2220a and the support slots 2232b can be configured to support the
staples 2220b.
Referring to FIGS. 46 and 47, the anvil 2240 can comprise a plurality of
staple forming pockets
2242 defined therein which can be configured to receive and deform the staples
2220a and 2220b
when the anvil 2240 is moved toward the staple cartridge 2200. In at least one
such
embodiment, the bottom surfaces of the support slots 2232a can be a first
distance 2201a away
from the top surfaces of the staple forming pockets 2242 while the bottom
surfaces of the support
slots 2232b can be a second distance 220 lb away from the top surfaces of the
staple forming
pockets 2242. In at least one such embodiment, the support slots 2232b are
positioned closer to
the anvil 2240 owing to the raised step in the support surface 2231 in which
they are defined.
Owing to the different distances 2201a and 2201b, in various embodiments, the
outer rows of
staples 2220a and the inner rows of staples 2220b can be deformed to different
formed heights.
In various circumstances, staples deformed to different formed heights can
apply different
clamping pressures or forces to the tissue T being stapled. In addition to the
above, the staples
can begin with different unformed staple heights. In at least one such
embodiment, referring
again to FIG. 46, the outer staples 2220a can have an initial, unformed height
which is greater
than the initial, unformed height of the inner staples 2220b. As illustrated
in FIGS. 46 and 47,
the inner staples 2220b, which have a shorter unformed height than the outer
staples 2220a, can
also have a shorter formed height than the outer staples 2220b. In various
alternative
embodiments, the inner staples 2220b may have a taller unformed height than
the outer staples
2220a yet have a shorter deformed staple height than the outer staples 2220a.
[0484] In various embodiments, further to the above, the anvil 2240 can be
moved into a
closed position, as illustrated in FIG. 47, in order to compress the cartridge
body 2210 and
deform the staples 2220a and 2220b. In certain embodiments, a surgical stapler
comprising the
end effector depicted in FIGS 46 and 47, for example, can further comprise a
cutting member
which can be configured to transect the tissue T positioned intermediate the
anvil 2240 and the
staple cartridge 2200. In at least one such embodiment, the anvil 2240, the
staple cartridge
channel 2230 and/or the staple cartridge 2200 can define a slot configured to
slidably receive a
cutting member therein. More particularly, the anvil 2240 can comprise a slot
portion 2249, the
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staple cartridge channel 2230 can comprise a slot portion 2239, and the staple
cartridge 2200 can
comprise a slot portion 2203 which can be aligned, or at least substantially
aligned, with one
another when the anvil 2240 is in a closed, or at least substantially closed,
position. In various
embodiments, the cutting member can be moved from the proximal end of the end
effector
toward the distal end of the end effector after the anvil 2240 has been closed
and the staples
2220a, 2220b have been deformed. In at least one embodiment, the cutting
member can be
moved independently of the staple deformation process. In certain embodiments,
the cutting
member can be advanced at the same time that the staples are being deformed.
In any event, in
at least one embodiment, the cutting member can be configured to incise the
tissue along a path
positioned intermediate the inner rows of staples 2220b.
[0485] In various embodiments, as illustrated in FIG. 47, the inner staples
2220b can be
formed to a shorter height than the outer staples 2220a wherein the inner
staples 2220b can apply
a larger clamping pressure or force to the tissue adjacent to the cut line
created by the cutting
member. In at least one such embodiment, the larger clamping pressure or force
created by the
inner staples 2220b can provide various therapeutic benefits such as reducing
bleeding from the
incised tissue T while the smaller clamping pressure created by the outer
staples 2220a can
provide flexibility within the stapled tissue. In various embodiments,
referring again to FIGS. 46
and 47, the anvil 2240 can further comprise at least one piece of buttress
material, such as
buttress material 2260, for example, attached thereto. In at least one such
embodiment, the legs
of the staples 2220a, 2220b can be configured to incise the buttress material
2260 and/or pass
through apertures in the buttress material 2260 when the staple cartridge 2200
is compressed by
the anvil 2240 and thereafter contact the staple forming pockets 2242 in the
anvil 2240. As the
legs of the staples 2220a, 2220b are being deformed, the legs can contact
and/or incise the
buttress material 2260 once again. In various embodiments, the buttress
material 2260 can
improve the hemostasis of and/or provide strength to the tissue being stapled.
[0486] In various embodiments, referring again to FIGS. 46 and 47, the bottom
surface of the
cartridge body 2210 can comprise a stepped contour which matches, or at least
substantially
matches, the stepped contour of the cartridge support surface 2231. In certain
embodiments, the
bottom surface of the cartridge body 2210 can deform to match, or at least
substantially match,
the contour of the cartridge support surface 2231. In various embodiments,
referring now to
FIG. 48, an end effector, similar to the end effector depicted in FIG. 46, for
example, can
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comprise a staple cartridge 2300 positioned therein. The staple cartridge 2300
can comprise a
compressible, implantable body 2310 comprising an inner layer 2312 and an
outer layer 2311
wherein, further to the above, the outer layer 2311 can be comprised of a
water impermeable
material in at least one embodiment. In various embodiments, the outer layer
2311 can extend
around the staples 2220a, 2220b and can be positioned intermediate the staples
2220a, 2220b and
the support slots 2232a, 2232b, respectively. In various embodiments,
referring now to FIG. 49,
an end effector, similar to the end effector depicted in FIG. 46, for example,
can comprise a
staple cartridge 2400 positioned therein. Similar to the staple cartridge
2300, the compressible,
implantable cartridge body 2410 of staple cartridge 2400 can comprise an inner
layer 2412 and
an outer layer 2411; however; in at least one embodiment, the cartridge body
2410 may not
comprise a cutting member slot therein. In at least one such embodiment, the
cutting member
may be required to incise the inner layer 2412 and/or the outer layer 2411,
for example, as it is
advanced through the staple cartridge.
[0487] In various embodiments, referring now to FIG. 50, an end effector of a
surgical stapler
can comprise an anvil 2540, a staple cartridge channel 2530, and a staple
cartridge 2500
positioned in the staple cartridge channel 2530. Similar to the above, the
staple cartridge 2500
can comprise a compressible, implantable cartridge body 2510, outer rows of
staples 2220a, and
inner rows of staples 2220b. The staple cartridge channel 2530 can comprise a
flat, or an at least
substantially flat, cartridge support surface 2531 and staple support slots
2532 defined therein.
The anvil 2540 can comprise a stepped surface 2541 and a plurality of staple
forming pockets,
such as forming pockets 2542a and 2542b, for example, defined therein. Similar
to the above,
the forming pockets 2542a and the support slots 2532 can define a distance
therebetween which
is greater than the distance between the forming pockets 2452b and the support
slots 2532. In
various embodiments, the anvil 2540 can further comprise a piece of buttress
material 2560
attached to the stepped surface 2541 of the anvil 2540. In at least one such
embodiment, the
buttress material 2560 can conform, or at least substantially conform, to the
stepped surface
2541. In various embodiments, the buttress material 2560 can be removably
attached to the
surface 2541 by at least one adhesive, such as fibrin and/or protein hydrogel,
for example. In
certain embodiments, the cartridge body 2510 can also comprise a stepped
profile which, in at
least one embodiment, parallels, or at least substantially parallels, the
stepped surface 2541 of the
anvil 2540. More particularly, in at least one embodiment, the anvil 2540 can
comprise steps
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2548 extending toward the staple cartridge 2500 wherein the steps 2548 can
comprise a step
height which equals, or at least substantially equals, the step height of the
steps 2508 extending
from the cartridge body 2510. In at least one such embodiment, as a result of
the above, the
amount of the compressible cartridge body 2510 that can be captured in the
first staples 2220a
can be different than the amount of the compressible cartridge body 2510 that
can be captured in
the second staples 2220b, for example.
[0488] In various embodiments, referring now to FIG. 51, an end effector can
comprise an anvil
2640, a staple cartridge channel 2530, and a staple cartridge 2600 positioned
therebetween. The
staple cartridge 2600 can comprise a compressible, implantable cartridge body
2610 including an
inner layer 2612, an outer layer 2611, and a plurality of staples, such as
staples 2220a and 2200b,
for example, positioned therein. In various embodiments, the anvil 2640 can
comprise a
plurality of staple forming pockets 2642 in surface 2641 and the staple
cartridge channel 2530
can comprise a plurality of staple forming slots 2532 defined in the support
surface 2531. As
illustrated in FIG. 51, the anvil surface 2641 can be parallel, or at least
substantially parallel, to
the cartridge support surface 2531 wherein each forming pocket 2642 can be
positioned an equal,
or at least substantially equal, distance away from an opposing and
corresponding staple support
slot 2532. In various embodiments, the staple cartridge 2600 can comprise
staples having the
same, or at least substantially the same, initial, unformed staple height and,
in addition, the same,
or at least substantially the same, formed staple height. In certain other
embodiments, the outer
rows of staples can comprise staples 2220a and the inner rows of staples can
comprise staples
2220b wherein, as discussed above, the staples 2220a and 2220b can have
different unformed
staple heights. When the anvil 2640 is moved toward the staple cartridge 2600
into a closed
position, the staples 2220a and 2220b can be formed such that they have the
same, or at least
substantially the same, formed staple height. In at least one such embodiment,
as a result of the
above, the formed outer staples 2220a and the inner staples 2220b may have the
same, or at least
substantially the same, amount of compressible cartridge body 2610 contained
therein; however,
as the outer staples 2220a have a taller unformed staple height than the inner
staples 2220b and
may have the same formed staple height nonetheless, a greater clamping
pressure can be
generated in the outer staples 2220a than the inner staples 2220b, for
example.
[0489] In various embodiments, referring now to FIG. 52, an end effector of a
surgical stapler
can comprise an anvil 2740, a staple cartridge channel 2530, and a staple
cartridge 2700
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positioned within the staple cartridge channel 2530. Similar to the above, the
staple cartridge
2700 can comprise a compressible, implantable cartridge body 2710 comprising
an inner layer
2712, an outer layer 2711, and a plurality of staples, such as staples 2220a
and 2220b, for
example, positioned therein. In at least one embodiment, the thickness of the
cartridge body
2710 can vary across its width. In at least one such embodiment, the cartridge
body 2710 can
comprise a center portion 2708 and side portions 2709, wherein the center
portion 2708 can
comprise a thickness which is greater than the thickness of the side portions
2709. In various
embodiments, the thickest portion of the cartridge body 2710 can be located at
the center portion
2708 while the thinnest portion of the cartridge body 2710 can be located at
the side portions
2709. In at least one such embodiment, the thickness of the cartridge body
2710 can decrease
gradually between the center portion 2708 and the side portions 2709. In
certain embodiments,
the thickness of the cartridge body 2710 can decrease linearly and/or
geometrically between the
center portion 2708 and the side portions 2709. In at least one such
embodiment, the tissue-
contacting surface 2719 of cartridge body 2710 can comprise two inclined, or
angled, surfaces
which slope downwardly from the center portion 2708 toward the side portions
2709. In various
embodiments, the anvil 2740 can comprise two inclined, or angled, surfaces
which parallel, or at
least substantially parallel, the inclined tissue-contacting surfaces 2719. In
at least one
embodiment, the anvil 2740 can further comprise at least one piece of buttress
material 2760
attached to the inclined surfaces of the anvil 2740.
[0490] In various embodiments, further to the above, the inner rows of staples
in the staple
cartridge 2700 can comprise the taller staples 2220a and the outer rows of
staples can comprise
the shorter staples 2220b. In at least one embodiment, the taller staples
2220a can be positioned
within and/or adjacent to the thicker center portion 2708 while the staples
2220b can be
positioned within and/or adjacent to the side portions 2709. In at least one
such embodiment, as
a result of the above, the taller staples 2220a can capture more material of
the implantable
cartridge body 2710 than the shorter staples 2220b. Such circumstances could
result in the
staples 2220a applying a greater clamping pressure to the tissue T than the
staples 2220b. In
certain embodiments, even though the taller staples 2220a may capture more
material of the
cartridge body 2710 therein than the shorter staples 2220b, the taller staples
2220a may have a
taller formed staple height than the shorter staples 2220b owing to the
inclined arrangement of
the staple forming pockets 2742a and 2742b. Such considerations can be
utilized to achieve a
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desired clamping pressure within the tissue captured by the staples 2220a and
2220b wherein, as
a result, the clamping pressure in the staples 2220a can be greater than, less
than, or equal to the
clamping pressure applied to the tissue by the staples 2220b, for example. In
various alternative
embodiments to the end effector illustrated in FIG. 52, the shorter staples
2220b can be
positioned within and/or adjacent to the thicker center portion 2708 of the
cartridge body 2710
and the taller staples 2220a can be positioned within and/or adjacent to the
thinner side portions
2709. Furtheimore, although the staple cartridge 2700 is depicted as
comprising inner and outer
rows of staples, the staple cartridge 2700 may comprise additional rows of
staples, such as staple
rows positioned intermediate the inner and outer rows of staples, for example.
In at least one
such embodiment, the intermediate staple rows can comprise staples having an
unformed staple
height which is intermediate the unformed staple heights of the staples 2220a
and 2220b and a
formed staple height which is intermediate the formed staple heights of the
staples 2220a and
2220b, for example.
[0491] In various embodiments, referring now to FIG. 53, an end effector of a
surgical stapler
can comprise an anvil 2840, a staple cartridge channel 2530, and a staple
cartridge 2800
positioned within the staple cartridge channel 2530. Similar to the above, the
staple cartridge
2800 can comprise a compressible, implantable cartridge body 2810 comprising
an inner layer
2812, an outer layer 2811, and a plurality of staples, such as staples 2220a
and 2220b, for
example, positioned therein. In at least one embodiment, the thickness of the
cartridge body
2810 can vary across its width. In at least one such embodiment, the cartridge
body 2810 can
comprise a center portion 2808 and side portions 2809, wherein the center
portion 2808 can
comprise a thickness which is less than the thickness of the side portions
2809. In various
embodiments, the thinnest portion of the cartridge body 2810 can be located at
the center portion
2808 while the thickest portion of the cartridge body 2810 can be located at
the side portions
2809. In at least one such embodiment, the thickness of the cartridge body
2810 can increase
gradually between the center portion 2808 and the side portions 2809. In
certain embodiments,
the thickness of the cartridge body 2810 can increase linearly and/or
geometrically between the
center portion 2808 and the side portions 2809. In at least one such
embodiment, the tissue-
contacting surface 2819 of cartridge body 2810 can comprise two inclined, or
angled, surfaces
which slope upwardly from the center portion 2808 toward the side portions
2809. In various
embodiments, the anvil 2840 can comprise two inclined, or angled, surfaces
which parallel, or at
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least substantially parallel, the inclined tissue-contacting surfaces 2819. In
at least one
embodiment, the anvil 2840 can further comprise at least one piece of buttress
material 2860
attached to the inclined surfaces of the anvil 2840. In various embodiments,
further to the above,
the outer rows of staples in the staple cartridge 2800 can comprise the taller
staples 2220a and
the inner rows of staples can comprise the shorter staples 2220b. In at least
one embodiment, the
taller staples 2220a can be positioned within and/or adjacent to the thicker
side portions 2809
while the staples 2220b can be positioned within and/or adjacent to the center
portion 2808. In at
least one such embodiment, as a result of the above, the taller staples 2220a
can capture more
material of the implantable cartridge body 2810 than the shorter staples
2220b.
[0492] As described above with regard to the embodiment of FIG. 46, for
example, the staple
cartridge channel 2230 can comprise a stepped support surface 2231 which can
be configured to
support the staples 2220a and 2220b at different heights with respect the
anvil 2240. In various
embodiments, the staple cartridge channel 2230 can be comprised of metal and
the steps in the
support surface 2231 may be formed in the support surface 2231 by a grinding
operation, for
example. In various embodiments, referring now to FIG. 54, an end effector of
a surgical
instrument can comprise a staple cartridge channel 2930 comprising a support
insert 2935
positioned therein. More particularly, in at least one embodiment, the staple
cartridge channel
2930 can be formed such that it has a flat, or at least substantially flat,
support surface 2931, for
example, which can be configured to support the insert 2935 which comprises
the stepped
surfaces for supporting the staples 2220a and 2220b of the staple cartridge
2200 at different
heights. In at least one such embodiment, the insert 2935 can comprise a flat,
or at least
substantially flat, bottom surface which can be positioned against the support
surface 2931. The
insert 2935 can further comprise support slots, grooves, or troughs 2932a and
2932b which can
be configured to support the staples 2220a and 2220b, respectively, at
different heights. Similar
to the above, the insert 2935 can comprise a knife slot 2939 defined therein
which can be
configured to permit a cutting member to pass therethrough. In various
embodiments, the staple
cartridge channel 2930 can be comprised of the same material as or a different
material than the
support insert 2935. In at least one embodiment, the staple cartridge channel
2930 and the
support insert 2935 can both be comprised of metal, for example, while, in
other embodiments,
the staple cartridge channel 2930 can be comprised of metal, for example, and
the support insert
2935 can be comprised of plastic, for example. In various embodiments, the
support insert 2935
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can be fastened and/or welded into the staple cartridge channel 2930. In
certain embodiments,
the support insert 2935 can be snap-fit and/or press-fit into the staple
cartridge channel 2930. In
at least one embodiment the support insert 2935 can be secured in the staple
cartridge channel
2930 using an adhesive.
[0493] In various embodiments, referring now to FIG. 55, an end effector of a
surgical stapler
can comprise an anvil 3040, a staple cartridge channel 3030, and a
compressible, implantable
staple cartridge 3000 positioned in the staple cartridge channel 3030. Similar
to the above, the
anvil 3040 can comprise a plurality of staple-forming pockets 3042 defined
therein and a knife
slot 3049 which can be configured to slidably receive a cutting member
therein. Also similar to
the above, the staple cartridge channel 3030 can comprise a plurality of
staple support slots 3032
defined therein and a knife slot 3039 which can also be configured to slidably
receive a cutting
member therein. In various embodiments, the staple cartridge 3000 can comprise
a first layer
3011, a second layer 3012, and a plurality of staples, such as staples 3020a
and 3020b, for
example, positioned therein. In at least one embodiment, the staples 3020a can
comprise an
unformed staple height which is taller than the unformed staple height of the
staples 3020b. In
various embodiments, the first layer 3011 can be comprised of a first
compressible material and
the second layer 3012 can be comprised of a second compressible material. In
certain
embodiments, the first compressible material can be compressed at a rate which
is higher than
the second compressible material while, in certain other embodiments, the
first compressible
material can be compressed at a rate which is lower than the second
compressible material. In at
least one embodiment, the first compressible material can be comprised of a
resilient material
which can comprise a first spring rate and the second compressible material
can be comprised of
a resilient material which can comprise a second spring rate which is
different than the first
spring rate. In various embodiments, the first compressible material can
comprise a spring rate
which is greater than the spring rate of the second compressible material. In
certain other
embodiments, the first compressible material can comprise a spring rate which
is less than the
spring rate of the second compressible material. In various embodiments, the
first compressible
layer can comprise a first stiffness and the second compressible layer can
comprise a second
stiffness, wherein the first stiffness is different than the second stiffness.
In various
embodiments, the first compressible layer can comprise a stiffness which is
greater than the
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stiffness of the second compressible layer. In certain other embodiments, the
first compressible
layer can comprise a stiffness which is less than the stiffness of the second
compressible layer.
[0494] In various embodiments, referring again to FIG. 55, the second layer
3012 of the staple
cartridge 3000 can comprise a constant, or at least substantially constant,
thickness across the
width thereof. In at least one embodiment, the first layer 3011 can comprise a
thickness which
varies across the width thereof In at least one such embodiment, the first
layer 3011 can
comprise one or more steps 3008 which can increase the thickness of the
cartridge body 3010 in
certain portions of the cartridge body 3010, such as the center portion, for
example. Referring
again to FIG. 55, the shorter staples 3020b can be positioned in or aligned
with the steps 3008,
i.e., the thicker portions of the cartridge body 3010, and the taller staples
3020a can be positioned
in or aligned with the thinner portions of the cartridge body 3010. In various
embodiments, as a
result of the thicker and thinner portions of the cartridge body 3010, the
stiffness of the cartridge
body 3010 can be greater along the inner rows of staples 3020b than the outer
rows of staples
3020a. In various embodiments, the first layer 3011 can be connected to the
second layer 3012.
In at least one such embodiment, the first layer 3011 and the second layer
3012 can comprise
interlocking features which can retain the layers 3011 and 3012 together. In
certain
embodiments, the first layer 3011 can comprise a first laminate and the second
layer 3012 can
comprise a second laminate, wherein the first laminate can be adhered to the
second laminate by
one or more adhesives. In various embodiments, the staple cartridge 3000 can
comprise a knife
slot 3003 which can be configured to slidably receive a cutting member
therein.
[0495] In various embodiments, referring now to FIG. 56, a staple cartridge
3100 can comprise
a compressible, implantable cartridge body 3110 comprising a single layer of
compressible
material and, in addition, a plurality of staples, such as staples 3020b, for
example, positioned
therein. In at least one embodiment, the thickness of the cartridge body 3110
can vary across the
width thereof In at least one such embodiment, the cartridge body 3110 can
comprise steps
3108 extending along the side portions thereof In various embodiments,
referring now to FIG.
57, a staple cartridge 3200 can comprise a compressible, implantable cartridge
body 3210
comprising a single layer of compressible material and, in addition, a
plurality of staples, such as
staples 3020b, for example, positioned therein. In at least one embodiment,
the thickness of the
cartridge body 3210 can vary across the width thereof In at least one such
embodiment, the
cartridge body 3210 can comprise steps 3208 extending along the center portion
thereof In
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various embodiments, referring now to FIG. 58, a staple cartridge 3300 can
comprise a
compressible, implantable cartridge body 3310 wherein, similar to the above,
the thickness of the
cartridge body 3310 can vary across the width thereof. In at least one
embodiment, the thickness
of the cartridge body 3310 can increase geometrically between the side
portions and the center
portion of the cartridge body 3310. In at least one such embodiment, the
thickness of the
cartridge body 3310 can be defined by an arcuate or curved profile and can
comprise an arcuate
or curved tissue-contacting surface 3319. In certain embodiments, the
thickness of the cartridge
body 3310, and the contour of the tissue-contacting surface 3319, can be
defined by one radius of
curvature or, alternatively, by several radiuses of curvature, for example. In
various
embodiments, referring now to FIG. 59, a staple cartridge 3400 can comprise a
compressible,
implantable cartridge body 3410 wherein the thickness of the cartridge body
3410 can increase
linearly, or at least substantially linearly, between the side portions and
the center portion of the
cartridge body 3410.
[0496] In various embodiments, referring now to FIG. 60, a staple cartridge
3500 can comprise
a compressible, implantable cartridge body 3510 and a plurality of staples
3520 positioned
therein. The implantable cartridge body 3510 can comprise a first inner layer
3512, a second
inner layer 3513, and an outer layer 3511. In at least one embodiment, the
first inner layer 3512
can comprise a first thickness and the second inner layer 3513 can comprise a
second thickness
wherein the second inner layer 3513 can be thicker than the first inner layer
3512. In at least one
alternative embodiment, the first inner layer 3512 can be thicker than the
second inner layer
3513. In another alternative embodiment, the first inner layer 3512 can have
the same, or at least
substantially the same, thickness as the second inner layer 3513. In certain
embodiments, each
staple 3520 can comprise a base 3522 and one or more deformable legs 3521
extending from the
base 3522. In various embodiments, each leg 3521 can comprise a tip 3523 which
is embedded
in the first inner layer 3511 and, in addition, each base 3522 of the staples
3520 can be embedded
in the second inner layer 3512. In at least one embodiment, the first inner
layer 3512 and/or the
second inner layer 3513 can comprise at least one medicament stored therein
and, in various
embodiments, the outer layer 3511 can encapsulate and seal the first inner
layer 3512 and the
second inner layer 3513 such that the medicament does not flow out of the
staple cartridge body
3510 until after the outer layer 3511 has been punctured by the staples 3520.
More particularly,
further to the above, an anvil can be pushed downwardly against tissue
positioned against the
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tissue-contacting surface 3519 of staple cartridge 3500 such that the
cartridge body 3510 is
compressed and the surface 3519 is moved downwardly toward, and at least
partially below, the
staple tips 3523 such that the tips 3523 rupture or puncture the outer layer
3511. After the outer
layer 3511 has been breached by the staple legs 3521, the at least one
medicament M can flow
out of the cartridge body 3510 around the staple legs 3521. In various
circumstances, additional
compression of the cartridge body 3510 can squeeze additional medicament M out
of the
cartridge body 3510 as illustrated in FIG. 61.
[0497] In various embodiments, referring again to FIG 60, the outer layer 3511
can comprise a
water impermeable, or at least substantially impermeable, wrap which can
configured to, one,
keep the medicament from prematurely flowing out of the staple cartridge 3500
and, two,
prevent fluids within a surgical site, for example, from prematurely entering
into the staple
cartridge 3500. In certain embodiments, the first inner layer 3512 can
comprise a first
medicament stored, or absorbed, therein and the second inner layer 3513 can
comprise a second
medicament stored, or absorbed, therein, wherein the second medicament can be
different than
the first medicament. In at least one embodiment, an initial compression of
the cartridge body
3510, which causes the rupture of the outer layer 3511, can generally express
the first
medicament out of the first inner layer 3512 and a subsequent compression of
the cartridge body
3510 can generally express the second medicament out of the second inner layer
3513. In such
embodiments, however, portions of the first medicament and the second
medicament may be
expressed simultaneously although a majority of the medicament that is
initially expressed can
be comprised of the first medicament and a majority of the medicament
subsequently expressed
thereafter can be comprised of the second medicament. In certain embodiments,
further to the
above, the first inner layer 3512 can be comprised of a more compressible
material than the
second inner layer 3513 such that the initial compression forces or pressure,
which can be lower
than the subsequent compression forces or pressure, can cause a larger initial
deflection within
the first inner layer 3512 than the second inner layer 3513. This larger
initial deflection within
the first inner layer 3512 can cause a larger portion of the first medicament
to be expressed from
the first inner layer 3512 than the second medicament from the second inner
layer 3513. In at
least one embodiment, the first inner layer 3512 can be more porous and/or
more flexible than
the second inner layer 3513. In at least one such embodiment, the first inner
layer 3512 can
comprise a plurality of pores, or voids, 3508 defined therein and the second
inner layer 3513 can
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comprise a plurality of pores, or voids, 3509 defined therein wherein, in
various embodiments,
the pores 3508 can be configured to store the first medicament in the first
inner layer 3512 and
the pores 3509 can be configured to store the second medicament in the second
inner layer 3513.
In certain embodiments, the size and density of the pores 3508 within the
first inner layer 3512
and the pores 3509 within the second inner layer 3513 can be selected so as to
provide a desired
result described herein.
[0498] In various embodiments, referring again to FIGS. 60 and 61, the outer
layer 3511, the
first inner layer 3512, and/or the second inner layer 3513 can be comprised of
a bioabsorbable
material. In at least one embodiment, the first inner layer 3512 can be
comprised of a first
bioabsorbable material, the second inner layer 3513 can be comprised of a
second bioabsorbable
material, and the outer layer 3511 can be comprised of a third bioabsorbable
material, wherein
the first bioabsorbable material, the second bioabsorbable material, and/or
the third
bioabsorbable material can be comprised of different materials. In certain
embodiments, the first
bioabsorbable material can be bioabsorbed at a first rate, the second
bioabsorbable material can
be bioabsorbed at a second rate, and the third bioabsorbable material can be
bioabsorbed at a
third rate, wherein the first rate, the second rate, and/or the third rate can
be different. In at least
one such embodiment, when a material is bioabsorbed at a particular rate, such
a rate can be
defined as the amount of material mass that is absorbed by a patient's body
over a unit of time.
As it is known, the bodies of different patients may absorb different
materials at different rates
and, thus, such rates may be expressed as average rates in order to account
for such variability.
In any event, a faster rate may be a rate in which more mass is bioabsorbed
for a unit of time
than a slower rate. In various embodiments, referring again to FIGS. 60 and
61, the first inner
layer 3512 and/or the second inner layer 3513 can be comprised of a material
which bioabsorbs
faster than the material comprising the outer layer 3511. In at least one such
embodiment, the
first inner layer 3512 and/or the second inner layer 3513 can be comprised of
a bioabsorbable
foam, tissue sealant, and/or hemostatic material, such as oxidized regenerated
cellulose (ORC),
for example, and the outer layer 3511 can be comprised of a buttress material
and/or plastic
material, such as polyglycolic acid (PGA) which is marketed under the trade
name Vicryl,
polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate
(PHA),
poliglecaprone 25 (PGCL) which is marketed under the trade name Monocryl,
polycaprolactone
(PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example.
In such
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embodiments, the first inner layer 3512 and/or the second inner layer 3513 can
immediately treat
the tissue and can reduce bleeding from the tissue, for example, wherein the
outer layer 3514 can
provide longer-term structural support and can be bioabsorbed at a slower
rate.
[0499] Owing to the slower rate of bioabsorbability of the outer layer 3511,
further to the
above, the outer layer 3511 can buttress or structurally reinforce the tissue
within the staple line
as it heals. In certain embodiments, one of the first inner layer 3512 and the
second inner layer
3513 can be comprised of a material which can be bioabsorbed faster than the
other such that, in
at least one embodiment, one of the layers can provide an initial release of a
therapeutic material
and the other layer can provide a sustained release of the same therapeutic
material and/or a
different therapeutic material. In at least one such embodiment, the rate in
which a therapeutic
material can be released from a layer 3512, 3513 can be a function of the
bioabsorbability of the
substrate layer in which the medicament is absorbed or dispersed. For example,
in at least one
embodiment, the substrate comprising the first inner layer 3512 can be
bioabsorbed faster than
the substrate comprising the second inner layer 3513 and, as a result, a
medicament can be
release from the first inner layer 3512 faster than the second inner layer
3513, for example. In
various embodiments, as described herein, one or more of the layers 3511,
3512, and 3513 of the
cartridge body 3510 can be adhered to one another by at least one adhesive,
such as fibrin and/or
protein hydrogel, for example. In certain embodiments, the adhesive can be
water soluble and
can be configured to release the connection between the layers as the staple
cartridge 3500 is
being implanted and/or some time thereafter. In at least one such embodiment,
the adhesive can
be configured to bioabsorb faster than the outer layer 3511, the first inner
layer 3512, and/or the
second inner layer 3513.
[0500] In various embodiments, referring now to FIGS. 62 and 63, a staple
cartridge, such as
staple cartridge 3600, for example, can comprise a cartridge body 3610
including a compressible
first layer 3611, a second layer 3612 attached to the first layer 3611, and a
removable
compressible layer 3613 attached to the second layer 3612. In at least one
such embodiment, the
first layer 3611 can be comprised of a compressible foam material, the second
layer 3612 can
comprise a laminate material adhered to the first layer 3611 utilizing one or
more adhesives, and
the third layer 3613 can comprise a compressible foam material removably
adhered to the second
layer 3612 utilizing one or more adhesives, for example. In various
embodiments, the staple
cartridge 3600 can further comprise a plurality of staples, such as staples
3620, for example,
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positioned in the cartridge body 3610. In at least one such embodiment, each
staple 3620 can
comprise a base 3622 positioned in the third layer 3613 and one or more
deformable legs 3621
extending upwardly from the base 3622 through the second layer 3612 and into
the first layer
3611, for example. In use, further to the above, the top surface 3619 of the
staple cartridge body
3610 can be pushed downwardly by an anvil until the staple legs 3621 penetrate
through the top
surface 3619 and the targeted tissue and contact the anvil. After the staple
legs 3621 have been
sufficiently deformed, the anvil can be moved away from the staple cartridge
3600 such that the
compressible layers thereof can at least partially re-expand. In various
circumstances, the
insertion of the staples through the tissue can cause the tissue to bleed. In
at least one
embodiment, the third layer 3613 can be comprised of an absorbent material,
such as protein
hydrogel, for example, which can draw blood away from the stapled tissue. In
addition to or in
lieu of the above, the third layer 3613 can be comprised of a hemostatic
material and/or tissue
sealant, such as freeze-dried thrombin and/or fibrin, for example, which can
be configured to
reduce the bleeding from the tissue. In certain embodiments, the third layer
3613 may provide a
structural support to the first layer 3611 and the second layer 3612 wherein
the third layer 3613
may be comprised of a bioabsorbable material and/or a non-bioabsorbable
material. In any
event, in various embodiments, the third layer 3613 can be detached from the
second layer 3612
after the staple cartridge 3610 has been implanted. In embodiments where the
third layer 3613
comprises an implantable-quality material, the surgeon can elect whether to
remove the third
layer 3613 of the cartridge body 3610. In at least one embodiment, the third
layer 3613 can be
configured to be removed from the second layer 3612 in one piece.
[0501] In various embodiments, the first layer 3611 can be comprised of a
first foam material
and the third layer 3613 can be comprised of a second foam material which can
be different than
the first foam material. In at least one embodiment, the first foam material
can have a first
density and the second foam material can have a second density wherein the
first density can be
different than the second density. In at least one such embodiment, the second
density can be
higher than the first density wherein, as a result, the third layer 3613 may
be less compressible,
or have a lower compression rate, than the first layer 3611. In at least one
alternative
embodiment, the first density can be higher than the second density wherein,
as a result, the first
layer 3611 may be less compressible, or have a lower compression rate, than
the third layer
3613. In various embodiments, referring now to FIGS. 64 and 65, a staple
cartridge 3700,
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similar to the staple cartridge 3600, can comprise a cartridge body 3710
comprising a first
compressible foam layer 3711, a second layer 3712 attached to the first layer
3711, and a
detachable third compressible foam layer 3713 removably attached to the second
layer 3712. In
at least one such embodiment, the third layer 3713 can comprise a plurality of
staple receiving
slots, or cut-outs, 3709 which can each be configured to receive at least a
portion of a staple
3620, such as a staple base 3622, for example, therein. In certain
embodiments, the staples 3620
can be configured to slide within the staple receiving slots 3709 or, stated
another way, the third
layer 3713 can be configured to slide relative to the staples 3620 when the
staple cartridge 3700
is positioned against the targeted tissue and compressed by an anvil, for
example. In at least one
embodiment, the receiving slots 3709 can be configured such that there is
clearance between the
staples 3620 and the side walls of the receiving slots 3709. In at least one
such embodiment, as a
result of the above, the staples 3620 may not capture a portion of the third
layer 3713 therein
when the staples 3620 are deformed, as illustrated in FIGS. 64 and 65. In
certain other
embodiments, the ends of the staple receiving slots 3709 adjacent to the
second layer 3712 can
be closed by a portion of the third layer 3713 and, as a result, at least a
portion of the third layer
3713 can be captured within the staples 3620 when they are deformed. In any
event, the third
layer 3713 can comprise one or more perforations and/or score marks 3708, for
example, which
can be configured to permit the third layer 3713 to be removed from the second
layer 3712 in
two or more pieces as illustrated in FIG. 64. In FIG. 64, one of the pieces of
the third layer 3713
is illustrated as being removed by a tool 3755. In various embodiments, the
perforations 3708
can be arranged along a line positioned intermediate a first row of staples
and a second row of
staples.
[0502] In various embodiments, referring again to FIGS. 64 and 65, the bases
3622 of the
staples 3620 can be positioned within the receiving slots 3709 wherein, in at
least one
embodiment, the side walls of the receiving slots 3709 can be configured to
contact and
releasable retain the staple legs 3621 in position. In certain embodiments,
although not
illustrated, the third layer 3713 can comprise an elongated slot surrounding
all of the staples
within a staple line. In at least one such embodiment, a staple cartridge
comprising four staple
rows, for example, can comprise an elongate slot aligned with each staple row
in the bottom
layer of the staple cartridge. Further to the above, at least a portion of the
staple cartridge 3600
and/or the staple cartridge 3700 can be implanted within a patient and at
least a portion of the
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staple cartridge can be removable from the patient. In at least one
embodiment, referring again
to FIGS. 64 and 65, the first layer 3711 and the second layer 3712 can be
captured within the
staples 3620 and can be implanted with the staples 3620, whereas the third
layer 3713 can be
optionally removed or detached from the staple cartridge 3700. In various
circumstances, the
removal of a portion of the implanted staple cartridge can reduce the amount
of material that the
patient's body has to reabsorb which can provide various therapeutic benefits.
In the event that a
portion of a staple cartridge is detached and removed, such as by a
laparoscopic tool 3755, for
example, the detached staple cartridge portion can be removed from the
surgical site through a
trocar, such as a trocar having a 5 mm aperture, for example. In certain
embodiments, a
cartridge body can comprise more than one layer that can be removed. For
example, the
cartridge body 3710 can comprise a fourth layer wherein the third layer of
3713 of the cartridge
body 3710 can be comprised of a hemostatic material and the fourth layer can
be comprised of a
support layer. In at least one such embodiment, a surgeon can remove the
support layer and then
elect whether to remove the hemostatic layer, for example.
[0503] In various embodiments, referring now to FIG. 66, a staple cartridge,
such as staple
cartridge 3800, for example, can comprise a cartridge body 3810 including an
outer layer 3811
and an inner layer 3812. The inner layer 3812 can be comprised of a
compressible foam material
and the outer layer 3811 can be at leas partially wrapped around the inner
layer 3812. In at least
one embodiment, the outer layer 3811 can comprise a first portion 3811a
configured to be
positioned on a first side of the inner layer 3812 and a second portion 381 lb
configured to be
positioned on a second side of the inner layer 3812 wherein the first portion
3811a and the
second portion 3811b can be connected by a flexible hinge, such as hinge 3809,
for example. In
at least one such embodiment, at least one adhesive, such as fibrin and/or
protein hydrogel, for
example, can be applied to the first side and/or the second side of the inner
layer 3812 in order to
secure the portions of the outer layer 3811 thereto. In various embodiments,
the outer layer 3811
can comprise one or more fastening members extending therefrom. In at least
one such
embodiment, the outer layer 3811 can comprise a plurality of deformable legs
3821 extending
from one side of the outer layer 3811 which can be seated in the compressible
inner layer 3812.
In at least one such embodiment, the legs 3821 may not protrude from the
second side of the
inner layer 3812 while, in at least one alternative embodiment, the legs 3821
may at least
partially protrude from the inner layer 3812. When the compressible cartridge
body 3810 is
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compressed, in use, the legs 3821 can be configured to pierce the inner layer
3812 and the
second portion 3811b of the outer layer 3811. In certain embodiments, the
second portion 3811b
of the outer layer 3811 can comprise apertures, such as apertures 3808, for
example defined
therein which can be configured to receive the staple legs 3821. In certain
embodiments, at least
portions of the staple cartridge 3800 can comprise a knife slot 3803 which can
be configured to
slidably receive a cutting member therein. In at least one such embodiment,
the knife slot 3803
may not extend entirely through the thickness of the cartridge body 3810 and,
as a result, the
cutting member may incise the cartridge body 3810 as it is moved relative
thereto.
[0504] In various embodiments, referring now to FIG. 67, a staple cartridge
3900 can
comprise, similar to staple cartridge 3800, a cartridge body 3910 including an
inner layer 3812
and an outer layer 3811, wherein the outer layer 3811 can comprise a first
portion 3811a
positioned adjacent to the first side of the inner layer 3812 and a second
portion 3811b
positioned adjacent to the second side of the inner layer 3812. In at least
one embodiment,
similar to the above, the outer layer 3811 can comprise one or more fastening
members
extending therefrom. In at least one such embodiment, the outer layer 3811 can
comprise a
plurality of deformable legs 3921 extending from one side of the outer layer
3811 which can be
seated in the compressible inner layer 3812. In certain embodiments, each
deformable leg 3921
can comprise at least one hook or barb 3923 protruding therefrom which can be
configured to
engage the second portion 3811b of the outer layer 3811 and, as a result,
retain the outer layer
3811 to the inner layer 3812. In at least one such embodiment, the barbs 3923
can be configured
to protrude from the second side of the inner layer 3812 and extend through
the apertures 3808 in
the second portion 3811b of the outer layer 3811 such that the barbs 3923 can
engage the outside
surface of the outer layer 3811 and lock the outer layer 3811 to the inner
layer 3812. In order to
construct the staple cartridge 3900, the inner layer 3812 may be at least
partially compressed in
order to cause the barbs to protrude therefrom and enter into the apertures
3808. In at least one
such embodiment, the staple cartridge 3900 can be at least partially pre-
compressed when it is
inserted into a staple cartridge, for example. In certain embodiments, further
to the above, at
least a portion of the legs 3921 can be embedded within the first portion
3811a of the outer layer
3811 wherein, in at least one embodiment, the outer layer 3811 can be
comprised of a plastic
material, such as polydioxanone (PDS) and/or polyglycolic acid (PGA), for
example, and the
plastic material can be overmolded around at least a portion of the legs 3921.
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[0505] In various embodiments, referring now to FIGS. 68-72, a staple
cartridge, such as staple
cartridge 4000, for example, can comprise a cartridge body 4010 including a
compressible first
layer 4011 and a second layer 4012 and, in addition, a plurality of staples
4020 positioned within
the cartridge body 4010. In certain embodiments, referring to FIG. 70, each
staple 4020 can
comprise a base 4022 and at least one deformable leg 4023 extending from the
base 4022. In at
least one embodiment, referring to FIG. 68, the staple cartridge 4000 can be
positioned between
a staple cartridge channel 4030 and an anvil 4040 of an end effector of a
surgical stapler wherein
the second layer 4012 of the cartridge body 4010 and/or the bases 4022 of the
staples 4020 can
be positioned against the staple cartridge channel 4030. In various
embodiments, referring now
to FIG. 69, the second layer 4012 can comprise a layer of pledgets 4060
interconnected to one
another by a pledget support frame 4061. In at least one such embodiment, the
pledgets 4060
and the pledget support frame 4061 can be comprised of a molded plastic
material, such as
polyglycolic acid (PGA), for example. Each pledget 4060 can comprise one or
more apertures or
slots 4062 which can be configured to receive a staple leg 4021 extending
therethrough as
illustrated in FIGS. 70 and 71. Each pledget 4060 can further comprise a
receiving slot 4063
defined therein which can be configured to receive a base 4022 of a staple
4020. In various
embodiments, referring again to FIG. 69, the pledgets 4060 and/or pledget
support fame 4061
can comprise a plurality of score marks, perforations, or the like which can
be configured to
allow the pledgets 4060 to become detached from the pledget support frame 4061
at a desired
location. Similarly, referring to FIG. 71, one or more pledgets 4060 can be
connected to one
another along a line comprising perforations and/or score marks 4064, for
example. In use, the
compressible foam layer 4011 can be positioned against the targeted tissue T
and the cartridge
body 4010 can be compressed by the anvil 4040 such that the anvil 4040 can
deform the staples
4020. When the staples 4020 are deformed, the staple legs 4021 of each staple
4020 can capture
the tissue T, a portion of the first layer 4011, and a pledget 4060 within the
deformed staple.
When the staple cartridge channel 4030 is moved away from the implanted staple
cartridge 4060,
for example, the pledget support frame 4061 can be detached from the pledgets
4060 and/or the
pledgets 4060 can be detached from one another. In certain circumstances, the
pledgets 4060
can be detached from the frame 4061 and/or each other when the staples 4020
are being
deformed by the anvil 4040 as described above.
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[0506] In various embodiments described herein, the staples of a staple
cartridge can be fully
formed by an anvil when the anvil is moved into a closed position. In various
other
embodiments, referring now to FIGS. 73-76, the staples of a staple cartridge,
such as staple
cartridge 4100, for example, can be deformed by an anvil when the anvil is
moved into a closed
position and, in addition, by a staple driver system which moves the staples
toward the closed
anvil. The staple cartridge 4100 can comprise a compressible cartridge body
4110 which can be
comprised of a foam material, for example, and a plurality of staples 4120 at
least partially
positioned within the compressible cartridge body 4110 In various embodiments,
the staple
driver system can comprise a driver holder 4160, a plurality of staple drivers
4162 positioned
within the driver holder 4160, and a staple cartridge pan 4180 which can be
configured to retain
the staple drivers 4162 in the driver holder 4160. In at least one such
embodiment, the staple
drivers 4162 can be positioned within one or more slots 4163 in the driver
holder 4160 wherein
the sidewalls of the slots 4163 can assist in guiding the staple drivers 4162
upwardly toward the
anvil. In various embodiments, the staples 4120 can be supported within the
slots 4163 by the
staple drivers 4162 wherein, in at least one embodiment, the staples 4120 can
be entirely
positioned in the slots 4163 when the staples 4120 and the staple drivers 4162
are in their unfired
positions. In certain other embodiments, at least a portion of the staples
4120 can extend
upwardly through the open ends 4161 of slots 4163 when the staples 4120 and
staple drivers
4162 are in their unfired positions. In at least one such embodiment,
referring primarily now to
FIG. 74, the bases of the staples 4120 can be positioned within the driver
holder 4160 and the
tips of the staples 4120 can be embedded within the compressible cartridge
body 4110. In
certain embodiments, approximately one-third of the height of the staples 4120
can be positioned
within the driver holder 4160 and approximately two-thirds of the height of
the staples 4120 can
be positioned within the cartridge body 4110. In at least one embodiment,
referring to FIG. 73A,
the staple cartridge 4100 can further comprise a water impermeable wrap or
membrane 4111
surrounding the cartridge body 4110 and the driver holder 4160, for example.
[0507] In use, the staple cartridge 4100 can be positioned within a staple
cartridge channel, for
example, and the anvil can be moved toward the staple cartridge 4100 into a
closed position. In
various embodiments, the anvil can contact and compress the compressible
cartridge body 4110
when the anvil is moved into its closed position. In certain embodiments, the
anvil may not
contact the staples 4120 when the anvil is in its closed position. In certain
other embodiments,
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the anvil may contact the legs of the staples 4120 and at least partially
deform the staples 4120
when the anvil is moved into its closed position. In either event, the staple
cartridge 4100 can
further comprise one or more sleds 4170 which can be advanced longitudinally
within the staple
cartridge 4100 such that the sleds 4170 can sequentially engage the staple
drivers 4162 and move
the staple drivers 4162 and the staples 4120 toward the anvil. In various
embodiments, the sleds
4170 can slide between the staple cartridge pan 4180 and the staple drivers
4162. In
embodiments where the closure of the anvil has started the forming process of
the staples 4120,
the upward movement of the staples 4120 toward the anvil can complete the
forming process and
deform the staples 4120 to their fully formed, or at least desired, height. In
embodiments where
the closure of the anvil has not deformed the staples 4120, the upward
movement of the staples
4120 toward the anvil can initiate and complete the forming process and deform
the staples 4120
to their fully formed, or at least desired, height. In various embodiments,
the sleds 4170 can be
advanced from a proximal end of the staple cartridge 4100 to a distal end of
the staple cartridge
4100 such that the staples 4120 positioned in the proximal end of the staple
cartridge 4100 are
fully formed before the staples 4120 positioned in the distal end of the
staple cartridge 4100 are
fully formed. In at least one embodiment, referring to FIG. 75, the sleds 4170
can each comprise
at least one angled or inclined surface 4711 which can be configured to slide
underneath the
staple drivers 4162 and lift the staple drivers 4162 as illustrated in FIG.
76.
[0508] In various embodiments, further to the above, the staples 4120 can be
formed in order
to capture at least a portion of the tissue T and at least a portion of the
compressible cartridge
body 4110 of the staple cartridge 4100 therein. After the staples 4120 have
been formed, the
anvil and the staple cartridge channel 4130 of the surgical stapler can be
moved away from the
implanted staple cartridge 4100. In various circumstances, the cartridge pan
4180 can be fixedly
engaged with the staple cartridge channel 4130 wherein, as a result, the
cartridge pan 4180 can
become detached from the compressible cartridge body 4110 as the staple
cartridge channel 4130
is pulled away from the implanted cartridge body 4110. In various embodiments,
referring again
to FIG. 73, the cartridge pan 4180 can comprise opposing side walls 4181
between which the
cartridge body 4110 can be removably positioned. In at least one such
embodiment, the
compressible cartridge body 4110 can be compressed between the side walls 4181
such that the
cartridge body 4110 can be removably retained therebetween during use and
releasably
disengaged from the cartridge pan 4180 as the cartridge pan 4180 is pulled
away. In at least one
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such embodiment, the driver holder 4160 can be connected to the cartridge pan
4180 such that
the driver holder 4160, the drivers 4162, and/or the sleds 4170 can remain in
the cartridge pan
4180 when the cartridge pan 4180 is removed from the surgical site. In certain
other
embodiments, the drivers 4162 can be ejected from the driver holder 4160 and
left within the
surgical site. In at least one such embodiment, the drivers 4162 can be
comprised of a
bioabsorbable material, such as polyglycolic acid (PGA) which is marketed
under the trade name
Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS),
polyhydroxyalkanoate (PHA),
poliglecaprone 25 (PGCL) which is marketed under the trade name Monocryl,
polycaprolactone
(PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example.
In
various embodiments, the drivers 4162 can be attached to the staples 4120 such
that the drivers
4162 are deployed with the staples 4120. In at least one such embodiment, each
driver 4162 can
comprise a trough configured to receive the bases of the staples 4120, for
example, wherein, in at
least one embodiment, the troughs can be configured to receive the staple
bases in a press-fit
and/or snap-fit manner.
[0509] In certain embodiments, further to the above, the driver holder 4160
and/or the sleds
4170 can be ejected from the cartridge pan 4180. In at least one such
embodiment, the sleds
4170 can slide between the cartridge pan 4180 and the driver holder 4160 such
that, as the sleds
4170 are advanced in order to drive the staple drivers 4162 and staples 4120
upwardly, the sleds
4170 can move the driver holder 4160 upwardly out of the cartridge pan 4180 as
well. In at least
one such embodiment, the driver holder 4160 and/or the sleds 4170 can be
comprised of a
bioabsorbable material, such as polyglycolic acid (PGA) which is marketed
under the trade name
Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS),
polyhydroxyalkanoate (PHA),
poliglecaprone 25 (PGCL) which is marketed under the trade name Monocryl,
polycaprolactone
(PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example.
In
various embodiments, the sleds 4170 can be integrally formed and/or attached
to a drive bar, or
cutting member, which pushes the sleds 4170 through the staple cartridge 4100.
In such
embodiments, the sleds 4170 may not be ejected from the cartridge pan 4180 and
may remain
with the surgical stapler while, in other embodiments in which the sleds 4170
are not attached to
the drive bar, the sleds 4170 may be left in the surgical site. In any event,
further to the above,
the compressibility of the cartridge body 4110 can allow thicker staple
cartridges to be used
within an end effector of a surgical stapler as the cartridge body 4110 can
compress, or shrink,
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when the anvil of the stapler is closed. In certain embodiments, as a result
of the staples being at
least partially deformed upon the closure of the anvil, taller staples, such
as staples having an
approximately 0.18" staple height, for example, could be used, wherein
approximately 0.12" of
the staple height can be positioned within the compressible layer 4110 and
wherein the
compressible layer 4110 can have an uncompressed height of approximately
0.14", for example.
[0510] In various embodiments, referring now to FIGS. 77-80, a staple
cartridge, such as staple
cartridge 4200, for example, can comprise a compressible cartridge body 4210,
a plurality of
staples 4220 positioned therein, and a plurality of flexible lateral support
members 4234. In
various embodiments, referring now to FIG. 78, the staple cartridge 4200 can
be positioned
intermediate an anvil 4240 and a staple cartridge channel 4230 wherein, in at
least one
embodiment, the lateral support members 4234 can be attached to the staple
cartridge channel
4230. When the anvil 4240 is moved downwardly to compress the cartridge body
4210 and at
least partially deform the staples 4220, as illustrated in FIG. 79, the side
portions of the cartridge
body 4210 can bulge laterally and push the lateral support members 4234
outwardly. In at least
one such embodiment, the lateral support members 4234 can be attached to the
cartridge body
4210 and, when the cartridge body 4210 bulges laterally as described above,
the lateral support
members 4234 can detach from the cartridge body 4210 as illustrated in FIG.
79. In at least one
embodiment, the lateral support members 4234 can be adhered to the cartridge
body 4210
utilizing at least one adhesive, such as fibrin and/or protein hydrogel, for
example. Similar to the
above, the closing of the anvil 4240 may only partially deform the staples
4220, wherein the
formation of the staples 4220 can be completed by the advancement of one or
more sleds 4270
through the staple cartridge 4200 as illustrated in FIG. 80. In various
embodiments, referring
now to FIGS. 82 and 83, the sleds 4270 can be advanced from a proximal end of
the staple
cartridge 4200 to a distal end of the staple cartridge 4200 by a cutting
member 4280. In at least
one such embodiment, the cutting member 4280 can comprise a cutting element,
or knife, 4283,
which can be advanced through the tissue T and/or the compressible cartridge
body 4210. In
certain embodiments, the cutting member 4280 can comprise camming members 4282
which can
travel along the outside surfaces of the jaws 4230 and 4240 and move or hold
the jaws in
position. In various embodiments, as a result of the above, the staples 4220
can be formed into
their final shapes at the same time, or at least substantially the same time,
as the tissue T is
incised. In at least one such embodiment, the sleds 4270 can be positioned
distally with respect
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to the knife 4283 such that the tissue T is only incised when the proceeding
portion of the tissue
has been fully stapled, for example.
[0511] In various embodiments, referring again to FIGS. 82 and 83, the sleds
4270 can
comprise separate slidable members which are advanced together by the cutting
member 4280.
In at least one such embodiment, the sleds 4270 can be contained within the
staple cartridge
4200 and the cutting member 4280 can be advanced into the staple cartridge
4200 by a firing bar
4281 such that the cutting member 4280 engages the sleds 4270 and advances the
sleds 4270
distally. In certain embodiments, the sleds 4270 can be connected to one
another. In either
event, each sled 4270 can comprise an angled surface, or cam, 4271 which can
be configured to
lift the staples 4220 aligned within a staple row. In certain embodiments, the
angled surfaces
4271 can be integrally formed with the cutting member 4280. In at least one
embodiment,
referring again to FIGS. 82 and 83, each staple 4200 can comprise a base, at
least one
deformable member extending from the base, and a crown 4229 overmolded onto
and/or
positioned around at least a portion of the base and/or the deformable members
of the staple
4200. In various embodiments, such crowns 4229 can be configured to be driven
directly by a
sled 4270, for example. More particularly, in at least one embodiment, the
crowns 4229 of
staples 4220 can be configured such that the angled surfaces 4271 of the sleds
4270 can slide
underneath and directly contact the crowns 4229 without a staple driver
positioned therebetween.
In such embodiments, each crown 4229 can comprise at least one co-operating
angled or inclined
surface which can be engaged by an angled surface 4271 of the sleds 4270 such
that the co-
operating angled surfaces can drive the staples 4220 upwardly when the sleds
4270 are slid
underneath the staples 4220.
[0512] In various embodiments, referring now to FIG. 81, a staple cartridge,
such as staple
cartridge 4300, for example, can comprise a compressible body 4310 and a
plurality of staples
4320 positioned within the compressible body 4310. Similar to the above, the
staple cartridge
4300 can comprise flexible lateral supports 4334 which can be attached to a
staple cartridge
channel and/or adhered to the compressible body 4310. In addition to the
above, the flexible
lateral supports 4334 can be connected together by one or more struts, or
connection members,
4335 which can be configured to hold the lateral supports 4334 together. In
use, the connection
members 4335 can be configured to prevent, or at least inhibit, the lateral
supports 4334 from
becoming prematurely detached from the cartridge body 4310. In certain
embodiments, the
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connection members 4335 can be configured to hold the lateral supports 4334
together after the
staple cartridge 4300 has been compressed by an anvil. In such embodiments,
the lateral
supports 4334 can resist the lateral bulging, or displacement, of the lateral
portions of the
cartridge body 4310. In certain embodiments, a cutting member, such as cutting
member 4280,
for example, can be configured to transect the connection members 4335 as the
cutting member
4280 is moved distally within the cartridge body 4310. In at least one such
embodiment, the
cutting member 4280 can be configured to push one or more sleds, such as sleds
4270, for
example, distally in order to form the staples 4320 against an anvil. The
sleds 4270 can lead the
cutting edge 4283 such that the cutting member 4280 does not transect a
connection member
4335 until the staples 4320 adjacent to that connection member 4335 have been
fully formed, or
at least formed to a desired height. In various circumstances, the connection
members 4335, in
co-operation with the lateral supports 4334, can prevent, or at least reduce,
the lateral movement
of the compressible cartridge body 4310 and, concurrently, prevent, or at
least reduce, the lateral
movement of the staples 4320 positioned within the cartridge body 4310. In
such circumstances,
the connection members 4335 can hold the staples 4320 in position until after
they are deformed
and the connection members 4335 can be thereafter cut to release the lateral
portions of the
cartridge body 4310. As mentioned above, the lateral supports 4334 can be
connected to the
staple cartridge channel and, as a result, can be removed from the surgical
site with the staple
cartridge channel after the staple cartridge 4300 has been implanted. In
certain embodiments, the
lateral supports 4334 can be comprised of an implantable material and can be
left within a
surgical site. In at least one embodiment, the connection members 4335 can be
positioned
intermediate the cartridge body 4310 and the tissue T and, after the
connection members 4335
have been detached from the lateral supports 4334, the connections members
4335 can remain
implanted in the patient. In at least one such embodiment, the connection
members 4335 can be
comprised of an implantable material and, in certain embodiments, the
connection members
4335 can be comprised of the same material as the lateral supports 4334, for
example. In various
embodiments, the connection members 4335 and/or lateral supports 4334 can be
comprised of a
flexible bioabsorbable material such as polyglycolic acid (PGA) which is
marketed under the
trade name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS),
polyhydroxyalkanoate
(PHA), poliglecaprone 25 (PGCL) which is marketed under the trade name
Monocryl,
polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or
PCL, for
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example. In various embodiments, a connection member can comprise a sheet of
material
connecting the lateral supports 4334. In certain embodiments, a staple
cartridge can comprise
connection members extending across the top surface of the cartridge body 4310
and, in addition,
connection members extending around the bottom surface of the cartridge body
4310.
[0513] In various embodiments, referring now to FIG. 84, a staple cartridge
can comprise
staples, such as staples 4420, for example, which can comprise a wire portion
inserted into a
crown portion. In at least one embodiment, the wire portion can be comprised
of metal, such as
titanium and/or stainless steel, for example, and/or plastic, such as
polydioxanone (PDS) and/or
polyglycolic acid (PGA), for example. In at least one embodiment, the crown
portion can be
comprised of metal, such as titanium and/or stainless steel, for example,
and/or plastic, such as
polydioxanone (PDS) and/or polyglycolic acid (PGA), for example. In certain
embodiments, the
wire portion of each staple 4420 can comprise a base 4422 and deformable legs
4421 extending
from the base 4422 wherein the crown portion of each staple 4420 can comprise
a crown 4429
which can be configured to receive at least a portion of a base 4422 therein.
In order to assemble
the portions of each staple 4420, referring now to FIGS. 85A-85C, the legs
4421 of the wire
portion can be inserted into an opening 4426 in a crown 4429 wherein the
opening 4426 can be
configured to guide the legs 4421 into a base chamber 4427. The wire portion
can be further
inserted into the crown 4429 such that the legs 4421 exit the base chamber
4427 and the base
4422 of the wire portion enters into the base chamber 4427. In at least one
such embodiment, the
base chamber 4427 can be configured such that the wire portion is rotated
within the crown 4429
as the base 4422 enters into the base chamber 4427 such that the staple legs
4421 are pointed in
an upward, or at least substantially upward, direction. In various
embodiments, referring again
to FIG. 84, the crown 4429 can comprise exit holes 4425 which can be
configured to receive the
staple legs 4421 therein.
[0514] In various embodiments, further to the above, a surgical stapler can
comprise a sled
4470 configured to transverse the staple cartridge 4400 and staple cartridge
channel 4430 and
move the staples 4420 contained within the cartridge body 4410 toward an
anvil. In various
circumstances, the sled 4470 can be moved from a proximal end of the staple
cartridge channel
4430 to a distal end of the cartridge channel 4430 in order to implant the
cartridge body 4410 and
the staples 4420. In certain circumstances, the sled 4470 can be retracted or
returned to the
proximal end of the cartridge channel 4430 and another staple cartridge 4400
can be inserted into
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the cartridge channel 4430. Once the new staple cartridge 4400 has been
positioned within the
cartridge channel 4430, the sled 4470 can be advanced distally once again. In
various
embodiments, the surgical stapler may comprise one or more lock-out features
which can prevent
the sled 4470 from being advanced distally once again without a new staple
cartridge 4400 being
positioned within the cartridge channel 4430. In at least one such embodiment,
referring again to
FIG. 84, the staple cartridge channel 4430 can comprise a lock-out shoulder
4439 which can be
configured to prevent, or at least limit, the distal movement of the sled
4470. More particularly,
the sled 4470 can be configured to abut the shoulder 4439 unless the sled 4470
is at least
partially lifted upwardly over the shoulder 4439 by a lift feature 4428, for
example, extending
between the proximal-most staples 4420 within a staple cartridge 4400. Stated
another way,
absent the presence of the proximal-most staples 4420 in a new staple
cartridge 4400, the sled
4470 cannot be advanced. Thus, when an expended staple cartridge 4400 is
present within the
cartridge channel 4430, or no staple cartridge 4400 is present in the
cartridge channel 4430 at all,
the sled 4470 cannot be advanced within the cartridge channel 4430.
[0515] Further to the above, referring now to FIG. 86, a staple cartridge,
such as staple
cartridge 4500, for example, can be positioned within a staple cartridge
channel 4530 and can
comprise a compressible cartridge body 4510, a plurality of staples 4520
positioned within the
cartridge body 4510, and a cartridge pan, or retainer, 4580. In various
embodiments, the
compressible cartridge body 4510 can comprise an outer layer 4511 and an inner
layer 4512
wherein, in at least one embodiment, the outer layer 4511 can sealingly
enclose the inner layer
4512. In at least one such embodiment, the outer layer 4511 can extend between
the inner layer
4512 and the cartridge pan 4580. In certain other embodiments, the outer layer
4511 may only
partially surround the inner layer 4512 and, in at least one such embodiment,
the outer layer 4511
and the cartridge pan 4580 can co-operate to encompass, or at least
substantially encompass, the
inner layer 4512. In various embodiments, further to the above, the staples
4520 can be
supported by the cartridge pan 4580 wherein the cartridge pan 4580 can
comprise one or more
staple support channels configured to support the staples 4520. In certain
embodiments, the
cartridge pan 4580 can be attached to the cartridge body 4510 wherein, in at
least one such
embodiment, the cartridge body 4510 can be compressed laterally between
opposing side walls
of the cartridge pan 4580. In various embodiments, the side walls of the
cartridge pan 4580 can
support the cartridge body 4510 laterally and, in at least one such
embodiment, the cartridge pan
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4580 can comprise one or more walls, or fins, 4582 extending upwardly from the
bottom support
4583 into the cartridge body 4510. In at least one such embodiment, the
cartridge body 4510 can
comprise one or more slots, or channels, therein which can be configured to
receive and/or
interlock with the walls 4582. In various embodiments, the walls 4582 can
extend partially, or
almost entirely, through the cartridge body 4510. In at least one such
embodiment, the walls
4582 can extend longitudinally through the staple cartridge 4500 between a
first row of staples
4520 and a second row of staples 4520.
[0516] In various embodiments, the cartridge body 4510 and/or the cartridge
pan 4580 can
comprise co-operating retention features which can provide a snap-fit between
the cartridge pan
4580 and the cartridge body 4510. In certain embodiments, the staple cartridge
4500 can be
positioned within the cartridge channel 4530 such that the cartridge pan 4580
is positioned
against and/or attached to the cartridge channel 4530. In at least one
embodiment, the cartridge
pan 4580 can be detachably coupled to the cartridge channel 4530 such that,
after the staple
cartridge 4500 has been compressed by the anvil 4540 and the staples 4520 have
been deformed,
the cartridge pan 4580 can detach from the cartridge channel 4530 and can be
implanted with the
cartridge body 4510. In at least one such embodiment, the cartridge pan 4580
can be comprised
of a bioabsorbable material such as polyglycolic acid (PGA) which is marketed
under the trade
name Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS),
polyhydroxyalkanoate
(PHA), poliglecaprone 25 (PGCL) which is marketed under the trade name
Monocryl,
polycaprolactone (PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or
PCL, for
example. In certain embodiments, a surgical stapler can further comprise a
firing mechanism
and/or driver which can be slid intermediate the staple cartridge channel 4530
and a bottom drive
surface on the cartridge pan 4580 which can be configured to lift or eject the
cartridge pan 4580
from the cartridge channel 4530. In certain embodiments, the cartridge body
4510 can be
detachably coupled to the cartridge pan 4580 such that, after the staple
cartridge 4500 has been
compressed by the anvil 4540 and the staples 4520 have been deformed, the
cartridge body 4510
can detach from the cartridge pan 4580. In at least one such embodiment, the
cartridge pan 4580
can remain fixedly engaged with the cartridge channel 4530 such that the
cartridge pan 4580 is
removed from the surgical site with the cartridge channel 4530. In certain
embodiments, a
surgical stapler can further comprise a firing mechanism and/or driver which
can be slid
intermediate the staple cartridge pan 4580 and a bottom drive surface on the
cartridge body 4510
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which can be configured to lift or eject the cartridge body 4510 from the
cartridge pan 4580. In
at least one such embodiment, the staple cartridge 4500 can further comprise
staple drivers
positioned intermediate the cartridge pan 4580 and the staples 4520 such that,
as the firing
mechanism is slid distally, the staple drivers and the staples 4520 can be
driven upwardly toward
the anvil. In at least one such embodiment, the staple drivers can be at least
partially embedded
within the compressible cartridge body 4510.
[0517] In various embodiments, similar to the above, the staple cartridge 4500
can comprise a
lock-out feature which can be configured to prevent, or at least limit, the
distal movement of a
cutting member unless a unfired staple cartridge 4500 has been positioned
within the staple
cartridge channel 4530. In certain embodiments, the staple cartridge pan 4580
can comprise a
surface which lifts the cutting member upwardly and over a locking surface
within the staple
cartridge channel 4530, for example. In the event that a staple cartridge 4500
comprising a
cartridge pan 4580 is not present in the cartridge channel 4530, the cutting
member cannot be
advanced. In at least one embodiment, the proximal-most staples, and/or any
other suitable
staples, within a staple cartridge 4500 can comprise a lifting surface which
can sufficiently lift
the cutting member over the locking surface. In addition to or in lieu of the
above, various
portions of the staple cartridge 4500 can be comprised of materials having
different colors. In
such embodiments, a surgeon may be able to visually identify when an unfired
and/or fired staple
cartridge is present in the staple cartridge channel 4530. In at least one
such embodiment, the
outer layer 4511 of the cartridge body 4510 may have a first color, the
cartridge pan 4580 may
have a second color, and the staple cartridge channel 4530 may have a third
color. In the event
that the surgeon sees the first color, the surgeon may know that an unfired
cartridge 4500 is
present in the staple cartridge channel 4530; in the event that the surgeon
sees the second color,
the surgeon may know that a fired cartridge 4500 is present in the staple
cartridge channel 4530
and that the remaining cartridge pan 4580 needs to be removed; and in the
event that the surgeon
sees the third color, the surgeon may know that no portion of a staple
cartridge 4500 remains
within the cartridge channel 4530.
[0518] In various embodiments, referring now to FIG. 87, a staple cartridge,
such as staple
cartridge 4600, for example, can comprise a compressible, implantable
cartridge body 4610 and
a plurality of staples 4620 positioned therein. The cartridge body 4610 can
comprise an outer
layer 4611 and an inner layer 4612. In certain embodiments, the inner layer
4612 can comprise a
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plurality of pockets, such as pockets, or cavities, 4615, for example, defined
therein which can
facilitate the collapse of the cartridge body 4610. In at least one such
embodiment, the inner
layer 4612 can comprise a corrugated, or honeycomb-configured, lattice which
can be configured
to withstand a compressive force, or pressure, as long as the compressive
force, or pressure, does
not exceed a certain threshold value. When the threshold value has not been
exceeded, the inner
layer 4612 can deform at a linear, or at least substantially linear, rate with
respect to the
compressive force, or pressure, being applied. After the compressive force, or
pressure, has
exceeded the threshold value, the inner layer 4612 can suddenly succumb to
large deflections
and collapse, or buckle, as a result of the compressive load. In various
embodiments, the lattice
of the inner layer 4612 can be comprised of a plurality of sub-layers 4612a
which can be
connected together. In at least one embodiment, each sub-layer 4612a can
comprise a plurality
of alternating furrows and ridges, or waves, which can be aligned with the
alternating furrows
and ridges of an adjacent sub-layer 4612a. In at least one such embodiment,
the furrows of a
first sub-layer 4612a can be positioned adjacent to the ridges of a second sub-
layer 4612a and,
similarly, the ridges of the first sub-layer 4612a can be positioned adjacent
to the furrows of the
second sub-layer 4612a. In various embodiments, the adjacent sub-layers 4612a
can be adhered
to one another and/or the outer layer 4611 by at least one adhesive, such as
fibrin and/or protein
hydrogel, for example. FIG. 88 illustrates the staple cartridge 4600 after the
cartridge body 4610
has been collapsed and the staples 4620 have been deformed in order to capture
and hold tissue T
against the cartridge body 4610.
[0519] In various embodiments, referring now to FIGS. 89-91, a staple
cartridge, such as staple
cartridge 4700, for example, can comprise a compressible, implantable
cartridge body 4710 and
a plurality of staples 4720 positioned within the cartridge body 4710. Similar
to the above, the
cartridge body 4710 can comprise an outer layer 4711 and an inner layer 4712,
wherein the inner
layer 4712 can comprise a plurality of sub-layers 4712a. Also similar to the
above, each sub-
layer 4712a can comprise alternating furrows 4717 and ridges 4718 which can be
aligned with
one another to define pockets, or cavities, 4715 therebetween. In at least one
such embodiment,
the furrows 4717 and/or the ridges 4718 can extend along axes which are
parallel to one another
and/or parallel to a longitudinal axis 4709. In various embodiments, the
staples 4720 can be
aligned in a plurality of staple rows which can extend along axes which are
parallel to one
another and/or parallel to the longitudinal axis 4709. In various alternative
embodiments,
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referring again to FIGS. 87 and 88, the staples 4620 contained in the
cartridge body 4600 can
extend along axes which are traverse or perpendicular with respect to the axes
defined by the
furrows and ridges of the sub-layers 4612a. Referring again to FIGS. 89-91,
the staples 4720 can
extend through the furrows 4717 and the ridges 4718 wherein friction forces
between the staples
4720 and the sub-layers 4712a can hold the staples 4720 within the cartridge
body 4710. In
certain embodiments, the plurality of sub-layers 4712a can be comprised of a
buttress material
and/or plastic material, such as polydioxanone (PDS) and/or polyglycolic acid
(PGA), for
example, which can be configured to hold the staples 4720 in an upright
orientation, for example,
and/or hold the staples 4720 in alignment with respect to each other as
illustrated in FIGS. 89
and 90. FIG. 91 illustrates the staple cartridge 4700 after the cartridge body
4710 has been
collapsed and the staples 4720 have been deformed in order to capture and hold
tissue T against
the cartridge body 4710.
[0520] In various embodiments, referring again to FIGS. 89-91, the cartridge
body 4710 can
resiliently or elastically collapse when it is compressed. In at least one
such embodiment, the
waves formed within each sub-layer 4712a by the furrows 4717 and the ridges
4718 can be
flattened, or at least substantially flattened, when the cartridge body 4710
is compressed which
can collapse, or at least substantially collapse, the cavities 4715 defined
therebetween. In
various circumstances, the cartridge body 4710, or at least portions of the
cartridge body 4710,
can resiliently or elastically re-expand after the compressive force, or
pressure, has been
removed from the cartridge body 4710. In at least one such embodiment, the
connections
between the furrows 4717 and the ridges 4718 of adjacent sub-layers 4712a can
remain intact, or
at least substantially intact, when the cartridge body 4710 is compressed such
that, after the
compression force has been removed from the cartridge body 4710, the sub-
layers 4712a can
bias themselves away from each other and, as a result, at least partially re-
expand the cartridge
body 4710. In certain embodiments, the cartridge body 4710 can be plastically
deformed, or
crushed, when it is compressed and, as a result, the cartridge body 4710 may
not re-expand after
the compressive force, or pressure, has been removed from the cartridge body
4710. In certain
embodiments, referring now to FIG. 92, a staple cartridge, such as staple
cartridge 4800, for
example, can comprise a crushable cartridge body 4810 comprising an outer
layer 4811 and an
inner layer 4812, wherein the inner layer 4812 can comprise a corrugated,
honeycomb-
configured, lattice having a plurality of pockets, or cavities, 4815 defined
therein. In various
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embodiments, the walls defining the lattice of inner layer 4812 can comprise
one or more
weakened, or thin, cross-sections 4819 which can be configured to allow the
walls defining the
lattice to break when the cartridge body 4810 is compressed. In such
circumstances, the
cartridge body 4810 can be crushed when the staple cartridge 4800 is
implanted.
[0521] In various embodiments, referring now to FIGS. 93-95, a staple
cartridge, such as staple
cartridge 4900, for example, can comprise a cartridge body 4910 comprising an
outer layer 4911
and a plurality of collapsible elements 4912 positioned intermediate top and
bottom portions of
the outer layer 4911, for example. Referring primarily to FIGS. 93 and 94, the
staple cartridge
4900 can further comprise a plurality of staples 4920, wherein each staple
4920 can be
positioned in a collapsible element 4912. More particularly, each collapsible
element 4912 can
comprise a first portion 4912a, a second portion 4012b, and a third portion
4012c which can co-
operate to define a cavity 4915 therein which is configured to receive a
staple 4920. In use,
further to the above, the staple cartridge 4900 can be positioned within a
staple cartridge channel
and a compressive force can be applied to the tissue contacting surface 4919
in order to compress
the cartridge body 4910. As the tissue contacting surface 4919 is moved
downwardly, the
collapsible elements 4912 can collapse. In such circumstances, the second
portion 4912b of each
collapsible element 4912 can collapse into a corresponding first portion 4912a
and, similarly, the
third portion 4912c of each collapsible element 4912 can collapse into a
corresponding second
portion 4912b. As the cartridge body 4910 is compressed and the collapsible
elements 4912 are
collapsed, the staples 4920 positioned within the collapsible elements 4912
can be deformed, as
illustrated in FIG. 95. In various embodiments, the second portion 4912b of
each collapsible
element 4912 can be frictionally engaged and/or press-fit within a
corresponding first portion
4912a such that, once the compressive force applied to the collapsible element
4912 exceeds the
retention force retaining the first portion 4912a and the second portion 4912b
in their extended
position (FIG. 94), the first portion 4912a and the second portion 4912b can
begin to slide
relative to one another. Similarly, the third portion 4912e of each
collapsible element 4912 can
be frictionally engaged and/or press-fit within a corresponding second portion
4912b such that,
once the compressive force applied to the collapsible element 4912 exceeds the
retention force
retaining the second portion 4912b and the third portion 4912c in their
extended position (FIG.
94), the second portion 4912b and the third portion 4912c can begin to slide
relative to one
another.
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[0522] In many embodiments described herein, a staple cartridge can comprise a
plurality of
staples therein. In various embodiments, such staples can be comprised of a
metal wire
deformed into a substantially U-shaped configuration having two staple legs.
Other
embodiments are envisioned in which staples can comprise different
configurations such as two
or more wires that have been joined together having three or more staple legs.
In various
embodiments, the wire, or wires, used to form the staples can comprise a
round, or at least
substantially round, cross-section. In at least one embodiment, the staple
wires can comprise any
other suitable cross-section, such as square and/or rectangular cross-
sections, for example. In
certain embodiments, the staples can be comprised of plastic wires. In at
least one embodiment,
the staples can be comprised of plastic-coated metal wires. In various
embodiments, a cartridge
can comprise any suitable type of fastener in addition to or in lieu of
staples. In at least one such
embodiment, such a fastener can comprise pivotable arms which are folded when
engaged by an
anvil. In certain embodiments, two-part fasteners could be utilized. In at
least one such
embodiment, a staple cartridge can comprise a plurality of first fastener
portions and an anvil can
comprise a plurality of second fastener portions which are connected to the
first fastener portions
when the anvil is compressed against the staple cartridge. In certain
embodiments, as described
above, a sled or driver can be advanced within a staple cartridge in order to
complete the forming
process of the staples. In certain embodiments, a sled or driver can be
advanced within an anvil
in order to move one or more forming members downwardly into engagement with
the opposing
staple cartridge and the staples, or fasteners, positioned therein.
[0523] In various embodiments described herein, a staple cartridge can
comprise four rows of
staples stored therein. In at least one embodiment, the four staple rows can
be arranged in two
inner staple rows and two outer staple rows. In at least one such embodiment,
an inner staple
row and an outer staple row can be positioned on a first side of a cutting
member, or knife, slot
within the staple cartridge and, similarly, an inner staple row and an outer
staple row can be
positioned on a second side of the cutting member, or knife, slot. In certain
embodiments, a
staple cartridge may not comprise a cutting member slot; however, such a
staple cartridge may
comprise a designated portion configured to be incised by a cutting member in
lieu of a staple
cartridge slot. In various embodiments, the inner staple rows can be arranged
within the staple
cartridge such that they are equally, or at least substantially equally,
spaced from the cutting
member slot. Similarly, the outer staple rows can be arranged within the
staple cartridge such
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that they are equally, or at least substantially equally, spaced from the
cutting member slot. In
various embodiments, a staple cartridge can comprise more than or less than
four rows of staples
stored within a staple cartridge. In at least one embodiment, a staple
cartridge can comprise six
rows of staples. In at least one such embodiment, the staple cartridge can
comprise three rows of
staples on a first side of a cutting member slot and three rows of staples on
a second side of the
cutting member slot. In certain embodiments, a staple cartridge may comprise
an odd number of
staple rows. For example, a staple cartridge may comprise two rows of staples
on a first side of a
cutting member slot and three rows of staples on a second side of the cutting
member slot. In
various embodiments, the staple rows can comprise staples having the same, or
at least
substantially the same, unformed staple height. In certain other embodiments,
one or more of the
staple rows can comprise staples having a different unformed staple height
than the other staples.
In at least one such embodiment, the staples on a first side of a cutting
member slot may have a
first unformed height and the staples on a second side of a cutting member
slot may have a
second unformed height which is different than the first height, for example.
[0524] In various embodiments, referring now to FIGS. 96A-96D, an end effector
of a surgical
stapler can comprise a cartridge attachment portion, such as staple cartridge
channel 5030, for
example, a fastener cartridge removably positioned in the staple cartridge
channel 5030, such as
staple cartridge 5000, for example, and a jaw 5040 positioned opposite the
staple cartridge 5000
and the staple cartridge channel 5030. The staple cartridge 5000 can comprise
a compressible
body 5010 and a plurality of staples 5020, and/or any other suitable
fasteners, at least partially
positioned in the compressible body 5010. In at least one such embodiment,
each staple 5020
can comprise a base 5022 and, in addition, legs 5021 extending upwardly from
the base 5022,
wherein at least a portion of the legs 5021 can be embedded in the cartridge
body 5010. In
various embodiments, the compressible body 5010 can comprise a top, or tissue-
contacting,
surface 5019 and a bottom surface 5018, wherein the bottom surface 5018 can be
positioned
against and supported by a support surface 5031 of the staple cartridge
channel 5030. Similar to
the above, the support surface 5031 can comprise a plurality of support slots
5032 (FIG. 96D),
for example, defined therein which can be configured to receive and support
the bases 5022 of
the staples 5020. In various embodiments, the end effector of the surgical
stapler can further
comprise a retention matrix, such as retention matrix 5050, for example, which
can be
configured to engage the staples 5020 and capture tissue therebetween. In at
least one such
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embodiment, the retention matrix 5050 can be removably mounted to the jaw
5040. In use, once
the staple cartridge 5000 has been positioned within the staple cartridge
channel 5030, the jaw
5040, and the retention matrix 5050 attached thereto, can be moved toward the
staple cartridge
5000 and the staple cartridge channel 5030. In at least one embodiment, the
jaw 5040 can be
moved downwardly along an axis 5099 such that the jaw 5040 and the staple
cartridge channel
5030 remain parallel, or at least substantially parallel, to one another as
the jaw 5040 is closed.
More particularly, in at least one such embodiment, the jaw 5040 can be closed
in a manner such
that a tissue-contacting surface 5051 of the retention matrix 5050 is
parallel, or at least
substantially parallel, to the tissue-contacting surface 5019 of the staple
cartridge 5000 as the jaw
5040 is moved toward the staple cartridge 5000.
[0525] In various embodiments, referring now to FIG. 96A, the retention matrix
5050 can be
detachably secured to the jaw 5040 such that there is little, if any, relative
movement between the
retention matrix 5050 and the jaw 5040 when the retention matrix 5050 is
attached to the jaw
5040. In at least one embodiment, the jaw 5040 can comprise one or more
retention features
which can be configured to hold the retention matrix 5050 in position. In at
least one such
embodiment, the retention matrix 5050 can be snap-fit and/or press-fit into
the jaw 5040. In
certain embodiments, the retention matrix 5050 can be adhered to the jaw 5040
utilizing at least
one adhesive. In any event, the jaw 5040 can be moved into a position in which
the retention
matrix 5050 is in contact with the tissue T and the tissue T is positioned
against the tissue-
contacting surface 5019 of the staple cartridge 5000. When the tissue T is
positioned against the
staple cartridge 5000 by the jaw 5040, the compressible body 5010 of the
staple cartridge 5000
may or may not be compressed by the jaw 5040. In either circumstance, in
various
embodiments, the legs 5021 of the staples 5200 may not protrude through the
tissue-contacting
surface 5019 of the staple cartridge 5000 as illustrated in FIG. 96A.
Furthermore, as also
illustrated in FIG. 96A, the jaw 5040 can hold the tissue T against the
compressible body 5010
without engaging the retention matrix 5050 with the staples 5020. Such
embodiments can permit
a surgeon to open and close the jaw 5040 multiple times in order to obtain a
desired positioning
of the end effector within a surgical site, for example, without damaging the
tissue T. Other
embodiments are envisioned, however, where the staple tips 5023 can protrude
from the tissue-
contacting surface 5019 prior to the cartridge body 5010 being compressed by
the anvil 5040.
Once the end effector has been suitably positioned, referring now to FIG. 96B,
the jaw 5040 can
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be moved downwardly toward the staple cartridge channel 5030 such that the
compressible body
5010 is compressed by the anvil 5040 and such that the tissue-contacting
surface 5019 is pushed
downwardly relative to the staples 5020. As the tissue-contacting surface 5019
is pushed
downwardly, the tips 5023 of the staple legs 5021 can pierce the tissue-
contacting surface 5019
and pierce at least a portion of the tissue T. In such circumstances, the
retention matrix 5050
may be positioned above the staples 5020 such that the retention apertures
5052 of retention
matrix 5050 are aligned, or at least substantially aligned, with the tips 5023
of the staple legs
5021.
[0526] As the retention matrix 5050 is pushed downwardly along the axis 5099,
referring now
to FIG. 96C, the staple legs 5021 of staples 5020 can enter into the retention
apertures 5052. In
various embodiments, the staple legs 5021 can engage the side walls of the
retention apertures
5052. In certain embodiments, as described in greater detail below, the
retention matrix 5050
can comprise one or more retention members extending into and/or around the
retention
apertures 5052 which can engage the staple legs 5021. In either event, the
staple legs 5021 can
be retained in the retention apertures 5052. In various circumstances, the
tips 5023 of the staple
legs 5021 can enter into the retention apertures 5052 and can frictionally
engage the retention
members and/or the side walls of the apertures 5052. As the retention matrix
5050 is pushed
toward the bases 5022 of the staples 5020, the staple legs 5021 can slide
relative to the side walls
and/or the retention members. As a result of the above, sliding friction
forces can be created
between the staple legs 5021 and the retention matrix 5050 wherein such
sliding friction forces
can resist the insertion of the retention matrix 5050 onto the staples 5020.
In various
embodiments, the sliding friction forces between the retention matrix 5050 and
the staples 5020
can be constant, or at least substantially constant, as the retention matrix
5050 is slid
downwardly along the staple legs 5021 of the staples 5020. In certain
embodiments, the sliding
friction forces may increase and/or decrease as the retention matrix 5050 is
slid downwardly
along the staple legs 5021 owing to variations in geometry of the staple legs
5021, the retention
apertures 5052, and/or the retention members extending into and/or around the
retention
apertures 5052, for example. In various embodiments, the insertion of the
retention matrix 5050
onto the staples 5020 can also be resisted by the compressible body 5010 of
the staple cartridge
5000. More particularly, the compressible body 5010 can be comprised of an
elastic material,
for example, which can apply a resistive force to the retention matrix 5050
which increases as
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the distance in which the compressible body 5010 is compressed increases. In
at least one such
embodiment, the increase in the resistive force generated by the cartridge
body 5010 can be
linearly proportional, or at least substantially linearly proportional, with
respect to the distance in
which the cartridge body 5010 is compressed. In certain embodiments, the
increase in the
resistive force generated by the cartridge body 5010 can be geometrically
proportional with
respect to the distance in which the cartridge body 5010 is compressed.
[0527] In various embodiments, further to the above, a sufficient firing force
can be applied to
the jaw 5040 and the retention matrix 5050 in order to overcome the resistive
and friction forces
described above. In use, the retention matrix 5050 can be seated to any
suitable depth with
respect to the staples 5020. In at least one embodiment, the retention matrix
5050 can be seated
to a depth with respect to the bases 5022 of the staples 5020 in order to
secure two or more layers
of tissue together and generate compressive forces, or pressure, within the
tissue. In various
circumstances, the system comprising the retention matrix 5050 and the staples
5020 can allow a
surgeon to select the amount of compressive forces, or pressure, that is
applied the tissue by
selecting the depth in which the retention matrix 5050 is seated. For example,
the retention
matrix 5050 can be pushed downwardly toward the staple bases 5022 of the
staples 5020 until
the retention matrix 5050 is seated a certain depth 5011 away from the bottom
of the support
slots 5032, wherein a shorter depth 5011 can result in higher compressive
forces, or pressure,
being applied to the tissue T than a taller depth 5011 which can result in
lower compressive
forces, or pressure, being applied to the tissue T. In various embodiments,
the compressive
forces, or pressures, applied to the tissue T can be linearly proportional, or
at least substantially
linearly proportional, to the depth 5011 in which the retention matrix 5050 is
seated. In various
circumstances, the compressive forces, or pressure, applied to the tissue T
can depend on the
thickness of the tissue T positioned between the retention matrix 5050 and the
staple cartridge
5020. More particularly, for a given distance 5011, the presence of thicker
tissue T can result in
higher compression forces, or pressure, than the presence of thinner tissue T.
[0528] In various circumstances, further to the above, a surgeon can adjust
the depth in which
the retention matrix 5050 is seated in order to account for thicker and/or
thinner tissue positioned
within the end effector and to apply a certain or predetermined pressure to
the tissue T regardless
of the tissue thickness. For example, the surgeon can seat the retention
matrix 5050 to a shorter
depth 5011 when fastening thinner tissue T or a taller depth 5011 when
fastening thicker tissue T
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in order to arrive at the same, or at least substantially the same,
compression pressure within the
tissue. In certain embodiments, further to the above, a surgeon can
selectively determine the
amount of compressive pressure to apply to the tissue T positioned between the
retention matrix
5050 and the staple cartridge 5010. In various circumstances, a surgeon can
engage the retention
matrix 5050 with the staples 5020 and position the retention matrix 5050 a
first distance away
from the bases 5022 of the staples 5020 in order to apply a first compressive
pressure to the
tissue. The surgeon can alternatively position the retention matrix 5050 a
second distance away
from the bases 5022, which is shorter than the first distance, in order to
apply a second
compressive pressure to the tissue which is greater than the first pressure.
The surgeon can
alternatively position the retention matrix 5050 a third distance away from
the bases 5022, which
is shorter than the second distance, in order to apply a third compressive
pressure to the tissue
which is greater than the second pressure. In various embodiments, the
fastening system
comprising the retention matrix 5050 and the staples 5020 can be configured to
permit a surgeon
to apply a wide range of compressive pressures to the targeted tissue.
[0529] In various embodiments, referring now to FIG. 96D, the staple legs 5021
can be
inserted through the retention matrix 5050 such that the staple leg tips 5023
extend above the top
surface of the retention matrix 5050. In at least one embodiment, referring
again to FIG. 96C,
the jaw 5040 can further comprise clearance apertures 5042 defined therein
which can be
configured to receive the staple leg tips 5023 as they pass through the
retention apertures 5052 in
the retention matrix 5050. In at least one such embodiment, the clearance
apertures 5042 can be
aligned with the retention apertures 5052 such that the legs 5021 do not
contact the jaw 5040. In
various embodiments, the clearance apertures 5042 can have a sufficient depth
such that the
staple legs 5021 do not contact the jaw 5040 regardless of the distance in
which the retention
matrix 5050 is seated. After the retention matrix 5050 has been engaged with
the staples 5020
and seated to a desired position, referring now to FIG. 96D, the staple
cartridge channel 5030
and the jaw 5040 can be moved away from the tissue T. More particularly, the
staple cartridge
channel 5030 can be detached from the implanted staple cartridge 5000 and the
anvil 5040 can
be detached from the implanted retention matrix 5050. As the jaw 5040 is moved
away from the
retention matrix 5050 and the staple supports 5032 are moved away from the
staple bases 5022,
the distance 5011 between the retention matrix 5050 and the bottom of the
bases 5022 can be
maintained eventhough the jaw 5040 and the staple cartridge channel 5030 are
no longer
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providing support thereto. In various embodiments, the static friction forces
between the staple
legs 5021 and the retention matrix 5050 can be sufficient to maintain the
retention matrix 5050 in
position despite a biasing force being applied to the retention matrix 5050 by
the compressed
cartridge body 5010 and/or the compressed tissue T. In at least one such
embodiment, the
cartridge body 5010 can be comprised of a resilient material which, when
compressed, can apply
an elastic biasing force to the retention matrix 5050 and the staples 5020 in
a manner which
tends to push the retention matrix 5050 and the staples 5020 apart, although
such movement is
opposed by the frictional engagement between the staple legs 5021 and the
retention matrix
5050.
[0530] In various embodiments, as described above, a retention matrix can
comprise a plurality
of retention apertures, wherein each retention aperture can be configured to
receive a leg of a
fastener therein. In at least one embodiment, referring now to FIG. 97, a
portion of a retention
matrix 5150 is illustrated therein which can comprise a retention aperture
5152 defined by a
perimeter 5156. In various embodiments, the perimeter 5156 of the aperture
5152 can comprise
a circular, or at least substantially circular, profile and/or any other
suitable profile. In certain
embodiments, the retention matrix 5150 can comprise one or more retention
members, such as
retention members 5153, for example, which extend into the aperture 5152 and
can be
configured to engage a fastener leg when the fastener leg is inserted
therethrough. In at least one
such embodiment, each retention member 5153 can comprise a cantilever which
extends
inwardly toward a center axis 5159, i.e., toward the center of the aperture
5152. In various
embodiments, each cantilever can comprise a first end which is attached to the
retention matrix
body 5158 and a second end which forms the perimeter 5156 of the retention
aperture 5152. In
certain embodiments, the perimeter 5156 of a retention aperture 5152 can be
defined by a first
diameter, or width, and a fastener leg can be defined by a second diameter, or
width, wherein the
second diameter can be larger than the first diameter. In at least one such
embodiment, the
fastener leg can be configured to contact and deflect one or more of the
retention members 5153
in order to increase the diameter of the retention aperture 5152 as the
fastener leg is being
inserted therethrough. In certain embodiments, further to the above, the
fastener leg can define a
perimeter which is larger than the perimeter 5156 of the retention aperture
5152 such that the
fastener leg can expand the perimeter 5156 when the fastener leg is inserted
therein.
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[0531] In various embodiments, referring again to FIG. 97, the aperture 5152
can be defined by
the deformable members 5153, wherein each deformable member 5153 can be
configured to
deflect relative to, or independently of, the other deformable members 5153.
In at least one such
embodiment, adjacent deformable members 5153 can be separated by slots 5154
which can be
configured to permit each deformable member 5153 to flex relative to the
others. In certain
embodiments, each slot 5154 can comprise a first end 5155 in the retention
matrix body 5158, a
second end opening into the retention aperture 5152, and a constant, or at
least substantially
constant, width extending between the first end 5155 and the second end. In
various other
embodiments, the width of each slot 5154 may not be constant and each slot
5154 may increase
and/or decrease in width between the first and second ends thereof. In certain
embodiments, the
first ends 5155 of the slots 5154 can comprise an enlarged portion, such as a
circular portion,
which can provide, one, strain relief to the bases of the deformable members
5153 attached to the
retention matrix body 5158 and, two, means for increasing the flexibility of
the deformable
members 5153. In various embodiments, the geometry of the deformable members
5153, and/or
slots 5154, can be selected so as to provide the deformable members 5153 with
a desired
flexibility. In certain embodiments, for example, the slots 5154 can be
lengthened in order to
create longer deformable members 5153 which can be more flexible than
deformable members
5153 having a shorter length. In at least one embodiment, the width of each
deformable member
5153 can be selected so as to provide a desired flexibility thereof. More
particularly, deformable
members having a thinner width can be more flexible than deformable members
having a thicker
width. In certain embodiments, referring again to FIG. 97, the first ends of
the cantilevers of
deformable members 5153 attached to the retention matrix body 5158 can be
wider than the
second ends of the cantilevers. In at least one such embodiment, the
cantilevers can be tapered
in a linear, or at least substantially linear, manner between the first and
second ends thereof.
[0532] In various embodiments, referring again to FIG. 97, the retention
matrix body 5158 can
comprise a flat, or at least substantially flat, sheet of material having a
tissue-contacting surface
5151 and a top surface 5157. In at least one such embodiment, the tissue-
contacting surface
5151 and the top surface 5157 can be parallel, or at least substantially
parallel, to one another. In
various embodiments, each deformable member 5153 can comprise a first portion
5153a and a
second portion 5153b, wherein the first portion 5153a can extend in a first
direction and the
second portion 5153b can extend in a different, or second, direction. In at
least one such
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embodiment, the retention matrix body 5158 can define a plane and the first
portions 5153a of
the deformable members 5153 can lie within such a plane. In various
embodiments, the second
portions 5153b of the deformable members 5153 can extend at an angle relative
to the first
portions 5153a. In at least one such embodiment, the second portions 5153b can
extend in
directions which are pointed away from the top surface 5157 of the retention
matrix body 5158
and, in certain embodiments, the second portions 5153b can converge toward the
central axis
5159 of the retention aperture 5152. In any event, in various embodiments, the
second portions
5153b can be configured to deflect away from the central axis 5159 when the
fastener leg is
inserted therethrough. In embodiments where a staple leg 5021 of a staple 5020
is inserted into a
retention aperture 5152, the deformable members 5153 can deform in a direction
which is
generally away from the bases 5122 of the staples 5120. In certain
embodiments, as a result, the
deformable members 5153 can deflect in a general direction which is the same
as, or at least
substantially the same as, the direction in which the staple legs 5021 are
being inserted.
[0533] In various embodiments, referring again to FIG. BD, the second portions
5153b of the
deformable members 5153 can each comprise a sharp tip, for example, which can
be configured
to slide against a staple leg 5021 as the staple leg 5021 is inserted therein.
The sharp tips of the
second portions 5153b can also be configured to bite into the staple leg 5021
in the event that the
staple leg 5021 were to be pulled in the opposite direction, i.e., in a
direction which would
remove the staple leg 5021 from the retention aperture 5052. In certain
circumstances, the
second portions 5153b can be inclined at an angle relative to the side of the
staple leg 5021
which is greater than 90 degrees and, as a result, the second portions 5153b
may dig, or burrow,
into the side of the staple leg 5021 when the staple leg 5021 experiences a
force which tends to
withdraw the staple leg 5021 from the retention aperture 5052. In certain
embodiments, the
staple legs 5021 can comprise indentations and/or concavities, such as
microindentations, for
example, in the surfaces thereof which can be configured to receive the tips
of the deformable
members 5053, for example, therein. In at least one such embodiment, the tips
of the deformable
members 5053 can catch in and burrow into the indentations in the staple legs
5021 when a
withdrawing force is applied to the staple legs 5021. In various embodiments,
as a result of the
burrowing of the second portions 5153b into the staple legs 5021, forces
acting to remove the
staple legs 5021 from the retention apertures 5022 may only seat the second
portions 5153b
deeper into the staple legs 5021 and increase the force required to remove the
staple legs 5021.
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Furthermore, owing to the upward inclination of the second portions 5153b, in
at least one
embodiment, the second portions 5153b can be more permissive to the insertion
of a staple leg
5021 within a retention aperture 5152 and more resistive to withdrawal of the
staple leg 5021. In
at least one embodiment, as a result, the force required to insert a staple
leg 5021 into a retention
aperture 5022 may be less than the force required to remove the staple leg
5021 from the
retention aperture 5022. In various embodiments, the force needed to remove
the staple leg 5021
from the retention aperture 5022 can be approximately 50 percent greater than
the force needed
to insert the staple leg 5021 into the retention aperture 5022, for example.
In various other
embodiments, the force needed to remove the staple leg 5021 may between
approximately 10
percent and approximately 100 percent greater than the force needed to insert
the staple leg 5021,
for example. In certain embodiments, the force needed to remove the staple leg
5021 may be
approximately 100 percent, approximately 150 percent, approximately 200
percent, and/or
greater than approximately 200 percent larger than the force needed to insert
the staple leg 5021,
for example.
[0534] In certain embodiments, referring again to FIG. 97, the second portions
5153b can be
arranged circumferentially around the aperture 5152 and can define a pocket
therebetween.
More particularly, the second portions 5153b can define a pocket 5160 which
can be configured
to receive the tip of the fastener leg when it is inserted into the retention
aperture 5152. In
various embodiments, the second portions 5153b of the deformable members 5153
can comprise
an annular, or an at least substantially annular, contour which can co-
operatively define an
annular, or at least substantially annular, profile of the pocket 1560, for
example. In at least one
such embodiment, the second portions 5153b can define a conical or
frustoconical pocket. In
various embodiments, the pocket can be defined by a suitable number of
deformable members,
such as four deformable members 5153 (FIG. 97), six deformable members 5153
(FIG. 98), or
eight deformable members 5153 (FIG. 99), for example. In certain embodiments,
referring now
to FIG. 100, the deformable members of a retention matrix, such as retention
matrix 5250, for
example, can form a pyramidal shape, or an at least substantially pyramidal
shape, for example.
In various embodiments, a retention matrix 5250 can comprise a plurality of
retention apertures,
such as retention aperture 5252, for example, which can be defined by a
perimeter 5256. In
various embodiments, the perimeter 5256 can comprise a polygonal, or at least
substantially
polygonal, profile and/or any other suitable profile. In certain embodiments,
the retention matrix
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5250 can comprise one or more retention members, such as retention members
5253, for
example, which extend into the aperture 5252 and can be configured to engage a
fastener leg
when the fastener leg is inserted therethrough. In at least one such
embodiment, each retention
member 5253 can comprise a cantilever which extends inwardly toward a center
axis 5259, i.e.,
toward the center of the aperture 5252. In various embodiments, each
cantilever can comprise a
first end which is attached to the retention matrix body 5258 and a second end
which forms the
perimeter 5256 of the retention aperture 5252. In certain embodiments, the
perimeter 5256 of a
retention aperture 5252 can be defined by a first diameter, or width, and a
fastener leg can be
defined by a second diameter, or width, wherein the second diameter can be
larger than the first
diameter. In at least one such embodiment, the fastener leg can be configured
to contact and
deflect one or more of the retention members 5253 in order to increase the
diameter of the
retention aperture 5252 as the fastener leg is being inserted therethrough. In
certain
embodiments, further to the above, the fastener leg can define a perimeter
which is larger than
the perimeter 5256 of the retention aperture 5252 such that the fastener leg
can expand the
perimeter 5256 when the fastener leg is inserted therein.
[0535] In various embodiments, referring again to FIG. 100, the aperture 5252
can be defined
by the deformable members 5253, wherein each deformable member 5253 can be
configured to
deflect relative to, or independently of, the other deformable members 5253.
In at least one such
embodiment, adjacent deformable members 5253 can be separated by slots 5254
which can be
configured to permit each deformable member 5253 to flex relative to the
others. In various
embodiments, the retention matrix body 5258 can comprise a flat, or at least
substantially flat,
sheet of material having a tissue-contacting surface 5251 and a top surface
5257. In at least one
such embodiment, the tissue-contacting surface 5251 and the top surface 5257
can be parallel, or
at least substantially parallel, to one another. In various embodiments, each
deformable member
5253 can comprise a first portion 5253a and a second portion 5253b, wherein
the first portion
5253a can extend in a first direction and the second portion 5253b can extend
in a different, or
second, direction. In at least one such embodiment, the retention matrix body
5258 can define a
plane and the first portions 5253a of the deformable members 5253 can lie
within such a plane.
In various embodiments, the second portions 5253b of the deformable members
5253 can extend
at an angle relative to the first portions 5253a. In at least one such
embodiment, the second
portions 5253b can extend in directions which are pointed away from the top
surface 5257 of the
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retention matrix body 5258 and, in certain embodiments, the second portions
5253b can
converge toward the central axis 5259 of the retention aperture 5252. In any
event, in various
embodiments, the second portions 5253b can be configured to deflect away from
the central axis
5259 when the fastener leg is inserted therethrough. In certain embodiments,
referring again to
FIG. 100, the second portions 5253b can be arranged circumferentially around
the aperture 5252
and can define a pocket therebetween. More particularly, the second portions
5253b can define a
pocket which can be configured to receive the tip of the fastener leg when it
is inserted into the
retention aperture 5252. In various embodiments, the second portions 5253b of
the deformable
members 5253 can define a polygonal, or an at least substantially polygonal,
pocket, for
example. In various embodiments, the pocket can be defined by a suitable
number of
deformable members, such as four deformable members 5253 (FIG. 100) which can
define a
square, six deformable members 5253 (FIG. 101) which can define a hexagon, or
eight
deformable members 5253 (FIG. 102) which can define an octagon, for example.
[0536] In various embodiments, referring now to FIG. 103, a retention matrix,
such as
retention matrix 5350, for example, can be formed from a flat, or an at least
substantially flat,
sheet of material such as titanium and/or stainless steel, for example. In at
least one such
embodiment, a plurality of apertures 5352 can be formed in the body 5358 of
the retention
matrix 5350 by one or more stamping processes. The sheet of material can be
positioned in a
stamping die which, when actuated, can punch out certain portions of the
material in order to
form slots 5354, apertures 5355 of slots 5354, and/or the perimeter 5356 of
the retention aperture
5352, for example. The stamping die can also be configured to bend the
deformable members
5353 in a suitable configuration. In at least one such embodiment, the
stamping die can deform
the second portions 5353b upwardly relative to the first portions 5353a along
a crease line 5353c.
In various embodiments, referring now to FIG. 104, a retention matrix, such as
retention matrix
5450, for example, can comprise a plurality of retention apertures 5452.
Similar to the above,
the perimeter 5456 of each retention aperture 5452 can be defined by a
plurality of deformable
members 5453 separated by slots, or slits, 5454. In at least one such
embodiment, the entirety of
each deformable member 5453 can be bent upwardly wherein the free ends of the
cantilevers
comprising the deformable members 5453 can define the perimeter 5456. In
various
embodiments, the retention matrix 5450 can comprise a plurality of apertures
5455 surrounding,
or at least substantially surrounding, the retention aperture 5452. In at
least one such
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embodiment, the apertures 5455 can be arranged in a circular array surrounding
or enclosing a
perimeter defined by the fixed ends of the cantilevers of the deformable
members 5453. In
certain embodiments, each aperture 5455 can comprise a circular, or at least
substantially
circular, perimeter and/or any other suitable perimeter. In use, the apertures
5455 can provide,
one, strain relief to the bases of the deformable members 5453 attached to the
retention matrix
body 5458 and, two, means for increasing the flexibility of the deformable
members 5453. In
various embodiments, larger apertures 5455 can provide more flexibility to the
deformable
members 5453 as compared to smaller apertures 5455. Furthermore, apertures
5455 which are
closer to the deformable members 5453 can provide more flexibility as compared
to apertures
5455 which are further away.
[0537] In various embodiments, referring now to FIG. 105, a retention matrix,
such as
retention matrix 5550, for example, can comprise a plurality of retention
apertures 5552. Each
retention aperture 5552 can comprise an elongate slot 5554 having enlarged
circular, or at least
substantially circular, ends 5555. In at least one such embodiment, the ends
5555 can be defined
by a diameter which is wider than the slot 5554. In certain embodiments, the
elongate slot 5554
and the ends 5555 can positioned along, and/or centered along, a longitudinal
axis 5559. In
various embodiments, the slot 5554 and the ends 5555 can define two opposing
tabs 5553 which
can be configured to engage a leg of a fastener and deflect as the fastener
leg is inserted
therethrough. In at least one embodiment, ends 5555 having a larger perimeter,
or diameter, can
define longer tabs 5553 which can be more flexible than tabs 5553 defined by
ends 5555 having
a smaller perimeter, or diameter. In various embodiments, the ends 5555 can
have the same
perimeter and diameter and, in at least one such embodiment, each tab 5553 can
be symmetrical
about an axis which is perpendicular, or at least substantially perpendicular,
to the longitudinal
axis 5559. Alternatively, the ends 5555 can have different perimeters and/or
diameters wherein,
in at least one embodiment, each tab 5553 may not be symmetrical about its
axis. In at least one
such alternative embodiment, the tabs 5553 may twist about their axes as the
fastener leg is
inserted through the retention aperture 5552. In various embodiments,
referring now to FIG.
106, a retention matrix, such as retention matrix 5650, for example, can
comprise a plurality of
retention apertures 5652. Each retention aperture 5652 can comprise an
elongate slot 5654
comprising circular, or at least substantially circular, ends 5655. In at
least one such
embodiment, the elongate slot 5654 and the ends 5655 can be positioned along,
and/or centered
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along, a longitudinal axis 5659. In various embodiments, each end 5655 can be
defined by a
diameter which is the same as, or at least substantially the same as, the
width of the slot 5654.
[0538] In various embodiments, referring now to FIG. 107, a retention matrix,
such as
retention matrix 5750, for example, can comprise a plurality of retention
apertures 5752. Each
retention aperture 5752 can comprise a plurality of slots, such as slots 5754,
for example, having
enlarged ends 5755. In at least one such embodiment, the slots 5754 and the
ends 5755 can be
positioned along and/or centered along longitudinal axes 5759. In various
embodiments, the
axes 5759 can extend in directions which are perpendicular or transverse to
one another. In
certain embodiments, the slots 5754 and the ends 5755 can define four tabs
5753, for example,
which can be configured to engage a fastener leg and deflect when the fastener
leg is inserted
through the retention aperture 5752. In at least one embodiment, each tab 5753
can comprise a
triangular, or at least substantially triangular, configuration, such as an
equilateral triangle, for
example. In various other embodiments, referring now to FIG. 108, a retention
matrix, such as
retention matrix 5850, for example, can comprise a plurality of retention
apertures 5852. Each
retention aperture 5852 can comprise a plurality of slots, such as slots 5854,
for example, having
ends 5855, wherein the slots 5854 and the ends 5855 can be positioned along
and/or centered
along longitudinal axes 5859. In various embodiments, the axes 5859 can extend
in directions
which are perpendicular or transverse to one another. In certain embodiments,
the slots 5854 and
the ends 5855 can define tabs 5853 which can be configured to engage a
fastener leg and deflect
when the fastener leg is inserted through the retention aperture 5852. In at
least one
embodiment, each tab 5853 can comprise an arcuate profile. More particularly,
each tab 5853
can comprise a curved end, as opposed to a pointed end depicted in FIG. 105,
which can be
configured to contact the fastener leg.
[0539] In various embodiments, referring now to FIG. 109, a retention matrix,
such as
retention matrix 5950, for example, can comprise a plurality of retention
apertures 5952. Each
retention aperture 5952 can comprise a plurality of slots, such as slots 5954,
for example,
wherein each slot 5954 can extend along, and/or can be centered along, an axis
5959. In various
embodiments, the axes 5959 can be transverse to each other and, in at least
one such
embodiment, the axes 5959 can be arranged such that all of the axes 5959
extend through a
center of the retention aperture 5952 and are spaced equidistantly, or at
least substantially
equidistantly, from each other. In at least one embodiment, each slot 5954 can
comprise an open
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end facing the center of the retention aperture 5952 and a second, or closed,
end 5955 at the
opposite end of the slot 5954. Similar to the above, the slots 5954 and the
ends 5955 can define
three tabs 5953, for example, which can be configured to engage a fastener leg
and deflect when
the fastener leg is inserted into the retention aperture 5952. In various
embodiments, each tab
5953 can comprise an arcuate configuration extending between adjacent ends
5955 of the slots
5954. In various embodiments, referring now to FIG. 110, a retention matrix,
such as retention
matrix 6050, for example, can comprise a plurality of retention apertures
6052. Each retention
aperture 6052 can comprise a tab 6053 which can be configured to engage a
fastener leg and to
deflect when the fastener leg is inserted into the retention aperture 6052. In
at least one such
embodiment, the tab 6053 can comprise a base fixed to the retention matrix
body 6058 and a free
end comprising an arcuate or curved profile 6056 which can be configured to
contact the fastener
leg. In certain embodiments, the fastener leg can be a staple leg comprised of
a round wire
wherein the curved profile 6056 can be configured to match, or at least
substantially match, a
curved outer surface of the round wire.
[0540] In various embodiments, referring again to FIG. 110, the retention
matrix body 6058
can comprise a plurality of slots 6054 and apertures 6055 which can be
configured to define the
tab 6053 and various portions of the retention aperture 6052. In at least one
embodiment, the tab
6053 can comprise a rectangular configuration comprising parallel, or at least
substantially
parallel, sides. In certain embodiments, referring now to FIG. 111, a
retention matrix, such as
retention matrix 6150, for example, can comprise a plurality of retention
apertures 6152. Each
retention aperture 6152 can comprise a tab 6153 which can be configured to
engage a fastener
leg and to deflect when the fastener leg is inserted into the retention
aperture 6152. In at least
one such embodiment, the tab 6153 can comprise a base fixed to the retention
matrix body 6158
and a free end comprising an arcuate or curved profile 6156 which can be
configured to contact
the fastener leg. In various embodiments, the retention matrix body 6158 can
comprise a
plurality of slots 6154 and apertures 6155 which can be configured to define
the tab 6153 and
various portions of the retention aperture 6152. In at least one embodiment,
the tab 6153 can
comprise a tapered configuration comprising arcuate sides. In at least one
such embodiment, the
tab 6153 can taper geometrically with the base being wider than the free end,
for example.
[0541] In various embodiments, as described above, a fastening system can
comprise a
plurality of staples comprising staple legs which are inserted through a
plurality of retention
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apertures in a retention matrix. In certain embodiments, as described in
greater detail below, the
staples can be held in a first jaw and the retention matrix can be held in a
second jaw, wherein at
least one of the first jaw and the second jaw can be moved toward the other.
In various
circumstances, the staples positioned within the first jaw can be secured
therein such that the
staple legs are aligned with the retention apertures when the retention matrix
is engaged with the
staple legs. In certain embodiments, referring to FIGS. 112 and 113, a
fastener system can
comprise a staple cartridge 6200, for example, positioned in a first jaw of a
surgical stapler and a
retention matrix 6250, for example, positioned in a second jaw of the surgical
stapler. Referring
now to FIGS. 119 and 120, further to the above, the retention matrix 6250 can
comprise a
plurality of retention apertures 6252, wherein each retention aperture 6252
can comprise a
perimeter 6256 defined by one or more deflectable members 6253. In at least
one such
embodiment, further to the above, the deflectable members 6253 defining each
aperture 6252 can
define a pocket 6201. In various embodiments, each pocket 6201 can comprise a
curved and/or
concave surface, for example, which can be configured to guide a tip of a
staple leg into the
aperture 6252 in the event that the staple leg is misaligned with the
retention aperture 6252 and
initially contacts the deflectable members 6253 and/or the tissue-contacting
surface 6251, for
example.
[0542] In various embodiments, further to the above, the fastening system can
further comprise
a plurality of staples 6220 comprising staple legs 6221 which can be inserted
through the
retention apertures 6252 in the retention matrix 6250. In at least one such
embodiment, each
staple 6220 can comprise a substantially U-shaped configuration, for example,
comprising a base
6222 from which the staple legs 6221 can extend upwardly. In various
embodiments, referring
now to FIGS. 115 and 116, the retention apertures 6252 in the retention matrix
6250 can be
arranged in two parallel, or at least substantially parallel, longitudinal
rows, for example, which
can extend along, or parallel to, a longitudinal axis of the retention matrix.
In certain
embodiments, the retention apertures 6252 in a first row can be offset, or
staggered, with respect
to the retention apertures 6252 in a second row. In at least one such
embodiment, each staple
6220 can comprise a first staple leg 6221 positioned in a retention aperture
6252 in the first row
of and a second staple leg 6221 positioned in a retention aperture 6252 in the
second row
wherein, as a result, the bases 6222 can extend in a direction which is
transverse to the
longitudinal axis of the retention matrix 6250. In at least one such
embodiment, the staples 6220
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can be parallel, or at least substantially parallel, to one another. More
particularly, a base 6222a
of a staple 6220a be parallel to, or at least substantially parallel to, a
base 6222b of a staple
6220b which can be parallel to, or at least substantially parallel to, a base
6222c of a staple
6220c, for example. In at least one embodiment, the staple legs 6221a of
staple 6220a can define
a plane which is parallel to, or at least substantially parallel to, a plane
defined by the staple legs
6221b of staple 6220b which can be parallel to, or at least substantially
parallel to, a plane
defined by the staple legs 6221 of staple 6220c, for example.
[0543] In various embodiments, referring now to FIGS. 112 and 114, the staple
cartridge 6200
can comprise a plurality of staples 6220 and, in addition, an alignment matrix
6260 comprising a
plurality of alignment guides, such as slots, grooves, and/or apertures, for
example, which can be
configured to align the staples 6220. In various circumstances, the alignment
matrix 6260 can be
configured such that the staple legs 6221 of the staples 6220 are aligned with
the retention
apertures 6252 in the retention matrix 6250 before the retention matrix 6250
is engaged with the
staple legs 6221. In various embodiments, referring now to FIGS. 117 and 118,
the alignment
matrix 6260 can comprise a plurality of alignment apertures 6262 which can be
configured to
closely receive the staple legs 6221 of the staples 6220. In at least one such
embodiment, each
staple 6220 can comprise a base 6222 and two staple legs 6221 extending from
the base 6222
wherein the bases 6222 of the staples 6220 can extend around a bottom surface
6264 of the
retention matrix 6260 and the staple legs 6221 can extend upwardly through the
alignment
apertures 6262. In certain embodiments, each alignment aperture 6262 can be
circular, or at least
substantially circular, and can be defined by a diameter which is equal to or
slightly larger than
the diameter of the staple leg 6221 extending therethrough. In various
embodiments, the
alignment matrix 6260 can further comprise a plurality of raised members 6263
which can
extend upwardly from the top surface 6261 of the alignment matrix 6260 and
surround, or at
least partially surround, the alignment apertures 6262. In certain
embodiments, the raised
members 6263 can provide for longer alignment apertures 6262 wherein, in
various
circumstances, longer apertures 6262 can provide more control over the
alignment of the staple
legs 6221 than shorter apertures 6262.
[0544] In use, in various embodiments, a first jaw supporting the staple
cartridge 6200 can be
positioned on one side of the tissue that is to be stapled and a second jaw
supporting the retention
matrix 6250 can be positioned on the other side of the tissue. Once the jaws
have been suitably
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positioned relative to the tissue, in certain embodiments, the second jaw and
the retention matrix
6250 can be moved toward the staple cartridge 6200. As the staple legs 6221
arc being inserted
through the retention apertures 6252 of the retention matrix 6250, in various
embodiments, a
tissue-contacting, or bottom, surface 6251 of the retention matrix 6250 can
contact the tissue and
press the tissue against the tissue-contacting, or top, surface 6261 of the
alignment matrix 6260.
In various other embodiments, as described in greater detail further below,
the staple cartridge
6200 can further comprise a compressible cartridge body positioned above the
top surface 6261
of the alignment matrix 6260, for example, which can contact the tissue. In
certain
embodiments, referring again to FIGS. 114 and 118, the alignment matrix 6260
can further
comprise one or more apertures 6203 defined therein which, when the alignment
matrix 6260 is
positioned against tissue, can be configured to receive a portion of the
tissue therein. In
embodiments where a compressible cartridge body is positioned above and/or
against the
alignment matrix 6260, a portion of the compressible cartridge body can enter
into the apertures
6203 when the cartridge body is compressed. Similarly, the retention matrix
6250 can comprise
a plurality of apertures 6202 which can be configured to receive at least a
portion of the tissue
therein when the retention matrix 6250 is positioned against the tissue.
[0545] As the staple legs 6221 of the staples 6220 arc inserted through the
retention apertures
6252 of the retention matrix 6250, further to the above, the tips of the
staple legs 6221 may
protrude upwardly from the top surface 6257 of the retention matrix 6250. In
various
circumstances, as described above, the tips of the staple legs 6221 may remain
unbent after they
have been inserted through the retention apertures 6252. In certain
embodiments, referring now
to FIGS. 121-124, a fastening system comprising the staple cartridge 6200 and
the retention
matrix 6250 may further comprise a plurality of protective caps or covers,
such as caps 6270, for
example, which can be assembled to the staple legs 6221 protruding above the
retention matrix
6250. In various embodiments, each cap 6270 can entirely, or at least
partially, cover the sharp
end of a staple leg 6221 such that the sharp end does not contact tissue
positioned adjacent
thereto. In at least one embodiment, referring now to FIG. 124, each cap 6270
can comprise an
aperture 6271 defined therein which can be configured to closely receive a tip
of a staple leg
6221 therein. In various embodiments, the caps 6270 can be comprised of an
elastomeric
material, such as silicone, polyisoprene, sanoprene, and/or natural rubber,
for example. In at
least one embodiment, the aperture 6271 can comprise a perimeter or diameter
which is smaller
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than the perimeter or diameter of the staple leg 6221 inserted therein. In at
least one such
embodiment, the aperture 6271 in the protective cap 6270 can expand in order
to receive the
staple leg 6221 therein. In various alternative embodiments, the caps 6270 may
not comprise
apertures and the tips of the staple legs 6221 can be configured to incise the
caps 6270 as the legs
6221 are inserted therein. In any event, in various embodiments, each cap 6270
can be seated
onto a staple leg 6221 until the base 6272 of the cap 6270 abuts, or is
positioned adjacent to, the
top surface 6257 of the retention matrix 6250. In various circumstances, the
caps 6270 can be
configured such that they are seated snugly onto the tips of the staple legs
6221 such that they are
not easily removed therefrom. In certain embodiments, each cap 6270 can
comprise a conical, or
at least substantially conical, outer surface, for example. In various
embodiments, the caps 6270
can comprise any suitable shape, such as shapes comprising a parabolic, or at
least substantially
parabolic, outer surface, for example.
[0546] In various embodiments, the fastener system described above, for
example, could be
deployed using the surgical stapler depicted in FIGS. 125-127, for example. In
various
embodiments, the end effector can comprise a first jaw, or staple cartridge
channel, 6230 which
can be configured to support the staple cartridge 6200 therein and a second
jaw 6240 which can
be configured to support the retention matrix 6250 and the plurality of
protective caps 6270.
Referring primarily to FIG. 125, which illustrates the second jaw 6240 in an
open configuration,
the jaws 6230 and 6240 can be positioned relative to tissue T such that the
tissue T is positioned
intermediate the retention matrix 6250 and the staple cartridge 6200. In
various embodiments, as
discussed above, the staple cartridge 6200 can further comprise a compressible
cartridge body,
such as cartridge body 6210, for example, in which the staples 6220 and the
alignment matrix
6260 can be positioned. In at least one such embodiment, the tissue T can be
positioned against
a top surface of the cartridge body 6210. In certain embodiments, the second
jaw 6240 can
comprise a plurality of recesses, or apertures, 6245 configured to receive the
plurality of
protective caps 6270 and, in addition, one or more retention features, or
retainers, which can be
configured to hold the retention matrix 6250 in position over the caps 6270.
In at least one such
embodiment, the retention matrix 6250 can be configured to retain the caps
6270 in the apertures
6245. In various embodiments, referring now to FIG. 137, each aperture 6245
can be configured
to receive a portion of, or the entirety of, a cap 6270 therein. In certain
embodiments, the
apertures 6245 can be sufficiently sized and configured such that the caps
6270 can be secured
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therein by at least one of a press-fit and/or snap fit arrangement, for
example. In some
embodiments, at least one adhesive could be utilized to secure the caps 6270
in the apertures
6245. In at least one such embodiment, such an adhesive could be selected such
that caps 6270
can detach from the second jaw 6240 after the caps 6270 have been engaged with
the staple legs
6221 and the second jaw 6240 is moved away from the implanted fastener
assembly. In certain
embodiments, referring now to FIG. 138, the second jaw 6240 can further
comprise at least one
cover sheet 6246 which can be assembled to the second jaw 6240 and can extend
over and retain
the caps 6270 in the apertures 6245. In at least one such embodiment, at least
a portion of the
cover sheet 6246 can be secured to the jaw 6240 utilizing at least one
adhesive, for example. In
use, in at least one embodiment, the cover sheet 6246 can be at least
partially detached from the
jaw 6240 before the end effector is inserted into a surgical site. In certain
embodiments, the
cover sheet 6246 can be comprised of an implantable material, such as PDS
and/or PGA, for
example, which can be incised by the staple legs 6221 as the staple legs 6221
emerge from the
retention matrix 6250. In at least one such embodiment, the cover sheet 6246
can be secured in
the fastening system intermediate the covers 6270 and the retention matrix
6250.
[0547] Further to the above, referring now to FIG. 126, the jaw 6240 can be
moved from an
open position to a closed position in which the tissue T is positioned against
the retention matrix
6250 and the cartridge body 6210. In such a position, the retention matrix
6250 may not yet be
engaged with the staples 6220. In various embodiments, the jaw 6240 can be
moved between its
open position and its closed position by an actuator 6235. In at least one
such embodiment, the
jaw 6240 can comprise a distal pin 6243 and a proximal pin 6244 extending
therefrom, wherein
the distal pin 6243 can slide vertically, or at least substantially
vertically, within a distal slot
6233 defined in the cartridge channel 6230, and wherein the proximal pin 6244
can slide
vertically, or at least substantially vertically, within a proximal slot 6234
which is also defined in
the staple cartridge channel 6230. In use, the actuator 6235 can be retracted
proximally in order
to drive the pins 6243 and 6244 into the upper ends of their respective slots
6233 and 6234 as
illustrated in FIG. 126. In at least one such embodiment, the actuator 6235
can comprise a distal
drive slot 6236 and a proximal drive slot 6237, wherein the sidewalls of the
drive slots 6236 and
6237 can be configured to contact the distal pin 6243 and the proximal pin
6244, respectively,
and drive the pins 6243 and 6244 upwardly as the actuator 6235 is moved
proximally. More
particularly, as the actuator 6235 is moved proximally, the distal pin 6243
can slide up an
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inclined first portion 6236a of the distal drive slot 6236 into an
intermediate, or second, portion
6236b and, similarly, the proximal pin 6244 can slide up an inclined first
portion 6237a of the
distal drive slot 6237 into an intermediate, or second, portion 6237b. As the
pins 6243 and 6244
are both moved upwardly, the jaw 6240 can be rotated downwardly toward the
tissue T into a
closed position.
[0548] Further to the above, referring now to FIG. 127, the actuator 6235 can
be pulled further
proximally in order to push the second jaw 6240 downwardly toward the first
jaw 6230,
compress the cartridge body 6210, and engage the retention matrix 6250 and the
plurality of
protective caps 6270 with the staple legs of the staples 6220. In at least one
such embodiment,
the additional proximal movement of the actuator 6235 can cause the sidewalls
of the drive slots
6236 and 6237 to contact the pins 6243 and 6244, respectively, and drive the
pins 6243 and 6244
downwardly toward the bottom ends of the slots 6233 and 6234, respectively. In
such
circumstances, the actuator 6235 can be pulled proximally such that, one, the
distal pin 6243
exits the second portion 6236b of the drive slot 6236 and enters into an
inclined third portion
6236c and, similarly, the proximal pin 6244 exits the second portion 6237b of
the drive slot 6237
and enters into an inclined third portion 6237c. As the pins 6243 and 6244 are
both moved
downwardly, the second jaw 6240 can move downwardly toward the first jaw 6230
into a fired
position. In at least one such embodiment, the second jaw 6240 can be moved
downwardly such
that the retention matrix 6250 remains parallel, or at least substantially
parallel, to the top surface
of the cartridge body 6210 and/or parallel, or at least substantially
parallel, to the alignment
matrix 6260. In any event, once the retention matrix 6250 and the protective
caps 6270 have
been engaged with the staple legs 6221 of the staples 6220, as illustrated in
FIG. 129, the second
jaw 6240 can be returned to an open, or an at least substantially open,
position. In at least one
such embodiment, the actuator 6235 can be pushed distally in order to drive
the pins 6243 and
6244 to the top ends of the slots 6233 and 6234, respectively, and then driven
downwardly
toward the bottom ends of the slots 6233 and 6234 once the pins have passed
through the
intermediate portions 6236b and 6237b of the respective drive slots 6236 and
6237. Once the
second jaw 6240 has been opened, the first jaw 6230 can be detached from the
implanted staple
cartridge 6200 and the first and second jaws 6230, 6240 can be removed away
from the
implanted fastener assembly, as illustrated in FIG. 128.
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[0549] Referring to FIG. 127 once again, the reader will note that the pins
6243 and 6244 are
not illustrated as being seated in the very bottoms of their respective slots
6233 and 6234
eventhough the retention matrix 6250 and the caps 6270 have been engaged with
the staple legs
6221. Such circumstances can arise when thick tissue T is positioned between
the retention
matrix 6250 and the cartridge body 6210. In circumstances where thinner tissue
T is positioned
between the retention matrix 6250 and the cartridge body 6210, referring now
to FIG. 130, the
pins 6243 and 6244 can be drive further downwardly into their respective slots
6233 and 6234 as
illustrated in FIG 132. In general, in at least one such embodiment, the
actuator 6235 can be
pulled proximally in order to drive the pins 6243 and 6244 upwardly and
downwardly through
the progressions described above and illustrated in FIGS. 130-132 and, owing
to the thinner
tissue T, the retention matrix 6250 and the protective caps 6270 can be driven
further onto the
staple legs 6221 of the staples 6220, as illustrated in FIGS. 133 and 134. In
various
embodiments, as a result of the adjustability afforded by the retention matrix
6250, the same, or
at least substantially the same, compressive pressure can be obtained in the
fastened tissue
regardless of whether the tissue captured within the end effector is thick or
thin. In certain
embodiments, the adjustability afforded by the retention matrix 6250 can allow
a surgeon can
select whether to apply a larger compressive pressure or a smaller compressive
pressure to the
tissue by selecting the depth to which the retention matrix 6250 is seated. In
at least one such
embodiment, the range in which the retention matrix 6250 can be seated onto
the staple legs
6221 can be determined by the lengths, or ranges, of the slots 6233 and 6234,
for example.
[0550] In various embodiments, as described above, the protective caps 6270
can be comprised
of a soft or flexible material, for example, which can be configured to grip
the ends of the staple
legs 6221. In certain embodiments, the protective caps 6270 can be comprised
of a
bioabsorbable plastic, polyglycolic acid (PGA) which is marketed under the
trade name Vicryl,
polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate
(PHA),
poliglecaprone 25 (PGCL) which is marketed under the trade name Monocryl,
polycaprolactone
(PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example,
and/or a
biocompatible metal, such as titanium and/or stainless steel, for example. As
illustrated in FIG.
124, in at least one embodiment, each cap 6270 can be unconnected to the other
caps 6270. In
certain other embodiments, one or more caps 6270 can be mounted to the
retention matrix 6250.
In at least one such embodiment, the caps 6270 can be connected to the
retention matrix 6250 by
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at least one adhesive, for example, wherein the apertures 6271 in the caps
6270 can be aligned,
or at least substantially aligned, with the retention apertures 6252 in the
retention matrix 6270.
In various embodiments, referring now to FIG. 135, a protective cap, such as a
cap 6370, for
example, can define an inner cavity, or dome, 6374 which can be configured to
receive a tip of a
staple leg 6221, for example, therein. In at least one such embodiment, the
cap 6370 can
comprise a bottom 6372 and an aperture 6371 extending through the bottom 6372.
In various
embodiments, the aperture 6371 can be defined by one or more deflectable
members 6373 which
can be configured to deflect when the staple leg 6221 is inserted
therethrough. In certain
embodiments, two or more caps 6370, for example, can be connected together to
form an array
of caps 6370. In at least one such embodiment, referring now to FIG. 136, a
plurality of caps
6370 can be connected together by a sheet of material 6375. In certain
embodiments, the sheet
6375 can be sufficiently rigid in order to maintain a desired arrangement
and/or alignment of the
caps 6370. In at least one embodiment, the caps 6370 can be comprised of a
biocompatible
metal, such as titanium and/or stainless steel, for example, and the sheet
6375 can be comprised
of a bioabsorbable plastic, polyglycolic acid (PGA) which is marketed under
the trade name
Vicryl, polylactic acid (PLA or PLLA), polydioxanone (PDS),
polyhydroxyalkanoate (PHA),
poliglecaprone 25 (PGCL) which is marketed under the trade name Monocryl,
polycaprolactonc
(PCL), and/or a composite of PGA, PLA, PDS, PHA, PGCL and/or PCL, for example.
In
various embodiments, a sheet 6375 can be comprised of a bioabsorbable material
including an
anti-microbial agent, such as colloidal silver and/or triclosan, for example,
stored and/or
dispersed therein which can be released as the sheet 6375 is bioabsorbed, for
example.
[0551] In various embodiments, further to the above, the sheet 6375 can be
injection molded
around the caps 6370 utilizing an injection molding process, for example, such
that the caps
6370 are embedded in the sheet 6375. In certain other embodiments, the sheet
6375 can be
molded utilizing an injection molding process, for example, wherein apertures
6376 can be
formed in the sheet 6375 during the injection molding process and/or after the
injection molding
process utilizing a stamping process, for example. In either event, the caps
6370 can be inserted
into and secured in the apertures 6376 utilizing a press-fit and/or snap-fit
interconnection and/or
at least one adhesive. In certain embodiments, each cap 6370 can comprise an
annular groove
surrounding, or at least partially surrounding, the perimeter of the cap 6370
which can be
configured to receive the perimeter of an aperture 6376 therein. In certain
embodiments, the
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sheet 6375 can be comprised of a flexible and/or pliable material which can
permit relative
movement between the caps 6370. In at least one such embodiment, the flexible
sheet 6375 can
be comprised of a rubber, plastic, and/or silicone material, for example, and
the caps 6370 can be
comprised of a rigid material, such as metal, for example. In at least one
such embodiment,
similar to the above, the flexible material can be molded around the caps
6370. In certain
embodiments, the caps 6370 can be pressed into a pre-molded sheet 6375, for
example. In
various embodiments, the durometer of the flexible material can be selected to
provide a desired
stiffness of the sheet 6375. In certain embodiments, the sheet 6375 can be
configured such that it
comprises a flexible band. In any event, the sheet 6375 can facilitate the
assembly of the caps
6370 into an end effector as a plurality of the caps 6370 can be positioned
and/or aligned
simultaneously within the end effector. Furthermore, the sheet 6375 connecting
the caps 6370,
once implanted, can strengthen or bolster the tissue along the staple line,
for example. In
addition to or in lieu of a sheet connecting the caps 6370, the caps 6370 can
be connected
together by a plurality of links. In at least one such embodiment, such links
can be flexible and
can permit relative movement between the caps 6370.
[0552] In various embodiments, referring now to FIGS. 139 and 140, a
protective cap, such as
cap 6470, for example, can comprise a forming surface which can be configured
to deform a tip
of a staple leg. In at least one such embodiment, the cap 6470 can comprise a
base 6472 which
can include an aperture 6471 extending therethrough. In various embodiments,
the aperture
6471 can be configured to closely receive a staple leg, such as a staple leg
6221, for example,
therein. In at least one embodiment, the aperture 6471 can be defined by a
diameter or perimeter
which can be equal to or larger than the diameter or perimeter of the staple
leg 6221. In various
embodiments, the cap 6470 can further comprise a cavity, or dome, 6474 which
can be
configured to receive the tip of the staple leg 6221 as it is inserted into
the cap 6470. Referring
primarily to FIG. 140, the cap 6470 can further comprise an anvil, or forming
surface, 6473
which can be configured to deflect and deform the staple leg 6221. In various
circumstances, the
forming surface 6473 can be curved and/or concave, for example, and can be
configured to curl
the staple leg 6221 as it is inserted into the cap 6470. In certain
embodiments, the staple leg
6221 can be sufficiently deformed such that it cannot be withdrawn through the
aperture 6471
and, as a result, the cap 6470 can become locked to the staple leg 6221. In at
least one such
embodiment, the base 6472 of the cap 6470 can define a lip extending around
the aperture 6471
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which can prevent the deformed staple leg 6221 from being removed from the
cavity 6474. In
various circumstances, as a result of the above, one or more caps 6470 can
prevent, or inhibit, a
retention matrix, such as retention matrix 6250, for example, from backing up
or being
disengaged from the staples 6220. In various embodiments, although not
illustrated, the cap
6470 can be symmetrically, or at least substantially symmetrically, formed,
and the aperture
6471 can be located along a central axis 6479 extending through the cap 6470.
In various
alternative embodiments, referring again to FIG. 139, the aperture 6471 can be
offset with
respect to the central axis 6479. In at least one such embodiment, the offset
aperture 6471 can
allow the staple leg 6221 to contact a side of the forming surface 6473 and
curl over to the other
side of the forming surface 6473 instead of contacting the center of the
forming surface 6473, as
may occur in embodiments comprising a centered aperture 6471 mentioned above.
[0553] In various embodiments, as discussed above, a retention matrix, such as
retention
matrix 6250, for example, can be comprised of a sheet of material and a
plurality of retention
apertures 6252 extending therethrough. In at least some embodiments, the sheet
of material
comprising the retention matrix 6250 can be rigid or substantially inflexible.
In certain other
embodiments, a retention matrix can be comprised of an array of retention
matrix elements and a
plurality of flexible connectors, or links, connecting the retention matrix
elements. In various
embodiments, referring now to FIG. 141, a retention matrix, or a portion of
retention matrix,
6550 can comprise a plurality of element bodies 6505 which can be connected
together by one or
more connecting links 6507. In at least one embodiment, each element body 6505
can comprise
a plurality of deformable members 6553 which define a retention aperture 6552
therein. In
certain embodiments, the element bodies 6505 and the connecting links 6507 of
a retention
matrix 6550 can be integrally formed and can comprise a unitary piece of
material. In various
embodiments, the retention matrix 6550 can be stamped or cast, for example,
from a metal
material, such as titanium and/or stainless steel, for example. In at least
one embodiment, the
retention matrix 6550 can be comprised of plastic, such as
polyetheretherketone (PEEK),
polypropylene which is marketed under the trade name Prolene, polyester,
polyethylene
terephthalate which is marketed under the trade names Ethibond and Mersilene,
polyvinylidene
fluoride, polyvinylidene fluoride-co-hexafluoropropylene, poly
hexafluoropropylene-VDF which
is marketed under the trade name Pronova, and/or long-chain aliphatic polymers
Nylon 6 and
Nylon 6,6 which are marketed under the trade names Ethilon & Nurolon, for
example, and can
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be formed by an injection molding process, for example. In certain
embodiments, the element
bodies 6505 may not be integrally formed with the connecting links 6507. In
various
embodiments, a plurality of singular element bodies 6505 can be produced which
are
subsequently connected together and embedded in a retention matrix. In at
least one such
embodiment, the element bodies 6505 can be stamped from a metal material, such
as titanium
and/or stainless steel, for example, and placed in a plastic injection mold
wherein a plastic
material can be injected into the mold to form, one, a rim 6506 of material
surrounding, or at
least partially surrounding, the element bodies 6505 and, two, connecting
links 6507 extending
from the rims 6506. In certain other embodiments, one or more connector
lattices can be formed
comprising apertures defined within a plurality of rims 6506 wherein each such
aperture can be
configured to receive an element body 6505 therein. In at least one
embodiment, each element
body 6505 can comprise a circular, or at least substantially circular, outer
perimeter and,
similarly, each rim 6506 can define a circular, or at least substantially
circular, aperture therein,
wherein the diameter of the aperture can be equal to or smaller than the
diameter of the element
body 6505. In at least one such embodiment, the element bodies 6505 can be
press-fit or
embedded into the apertures in the rims 6505. In certain embodiments, the
element bodies 6505
can be secured in the apertures utilizing at least one adhesive.
[0554] In various embodiments, further to the above, a retention matrix can
comprise a
plurality of element bodies 6505 and a plurality of connecting links 6507
which can connect the
element bodies 6505 in any suitable array, such as those illustrated in FIGS.
142-145, for
example. Regardless of the pattern of the array, in various embodiments, the
connecting links
6507 can be configured to allow the element bodies 6505 and the retention
apertures 6552 to
move relative to one another. In at least one such embodiment, the lattice of
element bodies
6505 and connecting links 6507 comprising the retention matrix 6550, once
engaged with tissue,
can be configured to stretch, twist, contract, and/or otherwise flex in order
to permit at least some
movement within the tissue yet, at the same time, resist larger movements
thereof. In various
embodiments, each connecting link 6507 can comprise a flexible member
configured to stretch,
twist, and/or contract in order to permit the retention matrix 6550 to flex
intermediate the matrix
retention elements 6505, for example. Referring again to FIG. 141, each link
6507 extending
from a rim 6506 can be defined by a width which is narrower than the width of
the element body
6505 and/or the rim 6506. In certain embodiments, referring to FIGS. 142-145,
one or more
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links 6507 can comprise straight portions which extend along a line between
adjacent element
bodies 6506, for example. In at least one such embodiment, each link 6507 can
comprise a first
end attached to a first rim 6506 and a second end attached to a second rim
6506. In certain
embodiments, referring once again to FIG. 141, two or more links 6507 can be
connected to one
another. In at least one such embodiment, two or more links 6507 can be
connected at an
intermediate hinge 6509, for example. In various embodiments, the hinge 6509
can comprise a
reduction in cross-sectional thickness in one or more directions as compared
to the cross-
sectional thickness of the links 6507 which can permit the connected links
6507 to move relative
to each other, for example. In certain embodiments, the retention matrix 6550
can further
comprise hinges 6508 which can connect the links 6507 to the rims 6506 and
permit relative
movement between the links 6507 and the rims 6506. Similar to hinges 6509,
hinges 6508 can
comprise a reduction in cross-sectional thickness in one or more directions as
compared to the
cross-sectional thickness of the links 6507, for example.
[0555] In various embodiments, further to the above, the connected links 6507
can extend in
different directions. In at least one such embodiment, a first link 6507 can
extend in a first
direction and a second link 6507 can extend in a second direction, wherein the
first direction can
be different than the second direction. In certain embodiments, the first link
6507 can extend
along a first line and the second link 6507 can extend along a second line,
wherein the first line
and the second line can intersect each other at an angle, such as
approximately 30 degrees,
approximately 45 degrees, approximately 60 degrees, and/or approximately 90
degrees, for
example. In various embodiments, the hinges 6508 and/or hinges 6509 can
comprise living
hinges which can permit the links 6507 to move relative to each other a number
of times without
breaking. In certain embodiments, the hinges 6508 and/or hinges 6509 can
comprise frangible,
or easily-breakable, portions which can break when flexed too far and/or
flexed too many times.
In at least one such embodiment, such frangible portions can permit one or
more portions of the
retention matrix 6550 to break away from another portion of the retention
matrix 6550. In
various embodiments, the hinges 6508 and/or hinges 6509, for example, can
comprise sections of
the retention matrix 6550 which are easier to incise than the other portions
of the retention matrix
6550. More particularly, an implanted retention matrix, and the tissue
fastened by the implanted
retention matrix, may oftentimes by incised by a cutting member for various
reasons and, in
order to facilitate such cross-cutting, the hinges 6508 and/or hinges 6509 can
provide avenues, or
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thin sections, through which a cutting member can more easily pass through the
retention matrix
6550, for example. In various embodiments, further to the above, the
connecting links 6507 can
comprise one or more coined features or material upsets, for example, defined
therein which can
facilitate the bending, breakage, and/or incision of the connecting links
6507.
[0556] In various embodiments, a retention matrix can comprise a plurality of
retention matrix
elements, such as matrix element bodies 6505, for example, which can be
embedded in a flexible
sheet, or band, of material. In at least one embodiment, a flexible sheet of
material can be
formed from a bioabsorbable, elastomeric material, such as silicone, for
example, wherein the
flexible sheet can be produced with a plurality of apertures defined therein.
In at least one such
embodiment, a solid flexible sheet can be molded and a plurality of apertures
can be punched out
of the flexible sheet. In various alternative embodiments, the flexible sheet
can be molded and
the apertures defined therein can be formed during the molding process. In
either event, the
retention matrix elements 6505, for example, can be inserted into and retained
within the flexible
sheet. In certain other embodiments, similar to the above, the flexible sheet
can be formed
around the matrix elements 6505. In at least one embodiment, the flexible
sheet can be
comprised of a woven mesh, for example, and/or any other suitable material.
Such a woven
mesh, further to the above, may be easy to cross-cut.
[0557] In various embodiments, referring now to FIGS. 146 and 147, a fastener
system
comprising a retention matrix, such as retention matrix 6250, for example, can
further comprise a
cover, such as cover 6670, for example, which can cover the tips of the staple
legs 6221 when
they extend above the top surface 6257 of the retention matrix 6250. In
various embodiments,
the cover 6670 can be attached to the retention matrix 6250. In certain
embodiments, the cover
6670 and/or the retention matrix 6250 can comprise retention features which
can be configured
to retain the cover 6670 to the retention matrix 6250. In at least one
embodiment, at least one
adhesive can be utilized to adhere the cover 6670 to the retention matrix
6250. In at least one
embodiment, the cover 6670 can be comprised of a single layer, although the
cover 6670 is
illustrated as comprising two layers as described in greater detail further
below. In various
embodiments, referring primarily to FIG. 147, the tips of the staple legs 6221
can extend through
a bottom surface 6673 of the cover 6670; however, the cover 6670 can comprise
a sufficient
thickness such that the staple tips do not extend through the top surface 6675
of the cover 6670.
In at least one such embodiment, as a result, the tips of the staple legs 6221
may not protrude
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from the cover 6670. In various embodiments, the cover 6670 can comprise a
plurality of layers.
In at least one such embodiment, the cover 6670 can comprise a first layer
6671 and a second
layer 6672. In at least one embodiment, the first layer 6671 and the second
layer 6672 can be
attached to one another wherein, in at least one embodiment, the second layer
6672 can comprise
a bottom surface 6676 which is adhered to the first layer 6671. In various
embodiments, the first
layer 6671 and the second layer 6672 can comprise different thicknesses while,
in certain
embodiments, they can comprise the same thickness. In at least one embodiment,
the first layer
6671 and the second layer 6672 can comprise substantially the same width
and/or length. In
alternative embodiments, the layers 6671 and 6672 can comprise different
widths and/or lengths.
[0558] In various embodiments, further to the above, the first layer 6671 can
be comprised of a
compressible foam, mesh material, and/or hydrogel, for example, which can be
incised by the
staple legs 6211. In at least one embodiment, the second layer 6672 can be
comprise of a
tougher material, or skin, such as PGA and/or PDS, for example, and/or any
suitable buttress
material. In at least one such embodiment, the staple legs 6221 can be
configured to penetrate
the first layer 6671; however, in various embodiments, the staple legs 6221
may be unable to
penetrate the second layer 6672. In certain embodiments, the second layer 6672
can be
comprised of a material having a sufficient resiliency and/or toughness which
can permit the
second layer 6672 to be contacted and displaced by the staple leg 6221 but not
be incised, or
only marginally incised, by the staple tip of the staple leg 6221. Although
not illustrated, a cover
can comprise more than two layers wherein one or more of such layers may be
penetration-
resistant. In use, in at least one such embodiment, the retention matrix 6250
can be positioned
against the tissue to be fastened and pushed downwardly such that the staple
legs 6221 of the
staples 6220 are pushed through the tissue T and the retention apertures 6252
in the retention
matrix 6250 and enter into the first layer 6271 of the cover 6270. In various
embodiments, the
tips of the staple legs 6221 may not enter, or at least substantially enter,
into the second layer
6272 of the cover 6270. After the retention matrix 6250 has been suitably
positioned, the jaw
6240 can be opened and the cover 6670 and the retention matrix 6250 can detach
from the jaw
6240 as illustrated in FIG. 146. As illustrated in FIG. 146, a jaw 6640 can be
configured to hold
more than one retention matrix 6250 and cover 6670. In at least one such
embodiment, the jaw
6640 can comprise two channels 6679 which each can be configured to receive a
cover 6670
therein and a retention matrix 6250 positioned thereover such that the tissue-
contacting surface
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6251 of each retention matrix 6250 depends downwardly from the bottom of the
jaw 6240. In at
least one such embodiment, a retention matrix 6250 and a cover 6270 can be
housed in the jaw
6640 on each side of a knife slot 6678. In use, both retention matrices 6250
and covers 6670 can
be deployed simultaneously and/or to the same depth with respect to opposing
staple cartridges,
such as cartridges 6200, for example, positioned thereacross. Thereafter, in
various
embodiments, the fastened tissue can be incised along a cutting line by a
cutting member that
traverses the knife slot 6678 wherein the jaw 6640 can then be re-opened. In
certain
embodiments, the covers 6670 may not be attached to the retention matrix 6250.
In at least one
such embodiment, the covers 6670 can be positioned in the channels 6679 and
can be retained in
the channels 6679 by the retention matrices 6250 which can be secured to the
jaw 6640. In
various embodiments, the each retention matrix 6250 can be wider and/or longer
than their
respective covers 6670 such that the retention matrices 6250 can retain the
entirety of their
covers 6670 in position. In certain embodiments, each retention matrix 6250
can comprise the
same width and/or length as their respective cover 6670, for example.
[0559] In various embodiments, as described above, a fastener system can
comprise a layer of
material which can be attached to a retention matrix, such as retention matrix
6250, for example.
In at least one embodiment, referring now to FIG. 150, a layer of material
6870 can be attached
to the bottom surface 6251 of the retention matrix 6250. In certain
embodiments, the layer 6870
and/or the retention matrix 6250 can comprise retention features which can be
configured to
retain the layer 6870 to the retention matrix 6250. In at least one
embodiment, at least one
adhesive can be utilized to adhere the layer 6870 to the retention matrix
6250. In any event, the
layer 6870 can comprise a bottom, or tissue-contacting, surface 6873 which can
be configured to
contact the tissue T when the retention matrix 6250 is moved downwardly toward
the staples
6220 to engage the retention apertures 6252 with the staple legs 6221. In at
least one such
embodiment, the layer 6870 can be comprised of a compressible material, such
as a
bioabsorbable foam, for example, which can be compressed between the bottom
surface 6251 of
the retention matrix 6250 and the tissue T. In various embodiments, the layer
6870 can further
comprise at least one medicament stored and/or absorbed therein which can be
expressed from
the layer 6870 as the layer 6870 is compressed. In at least one embodiment,
the medicament can
comprise at least one tissue sealant, hemostatic agent, and/or anti-microbial
material, such as
ionized silver and/or triclosan, for example. In various embodiments, the
compression of the
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layer 6870 can squeeze the medicament from the layer 6870 such that the
entirety of, or at least a
significant portion of, the surface of the tissue T is covered with the
medicament. Furthermore,
as the layer 6870 is compressed and the staple legs 6221 penetrate the tissue
T and the layer
6870, the medicament can flow down the staple legs 6221 and treat the tissue
that has just been
incised by the staple legs 6221, for example. In various embodiments, the body
of the retention
matrix 6250 can comprise a first layer which is comprised of a biocompatible
material, such as
titanium and/or stainless steel, for example, and the bottom layer 6870 can
comprise a second
layer comprised of a bioabsorbable material, such as oxidized regenerated
cellulose (ORC),
biologically active agents like fibrin and/or thrombin (either in their liquid
state or freeze dried),
glycerin, absorbable porcine gelatin in either flue or foam configurations,
and/or anti-microbials,
such as ionized silver and/or triclosan, for example. Additional bioabsorbable
materials can
comprise Surgicel Nu-Knit, Surgicel Fibrillar, collagen/ORC which is a hybrid
with a built in
collagen matrix and is marketed under the trade name Promogran, polyglycolic
acid (PGA)
which is marketed under the trade name Vicryl, polylactic acid (PLA or PLLA),
polydioxanone
(PDS), polyhydroxyalkanoate (PHA), poliglecaprone 25 (PGCL) which is marketed
under the
trade name Monocryl, polycaprolactone (PCL), and/or a composite of PGA, PLA,
PDS, PHA,
PGCL and/or PCL, for example. Although only one layer 6870 is illustrated in
FIG. 150, any
suitable number of layers could be used. In at least one embodiment, a first
layer comprising a
first medicament could be attached to the retention matrix 6250 and a second
layer comprising a
second, or different, medicament could be attached to the first layer. In at
least one such
embodiment, a plurality of layers could be used wherein each layer can
comprise a different
medicament and/or a different combination of medicaments contained therein.
[0560] In various embodiments, referring now to FIG. 148, a fastener system
can comprise a
layer of material 6770 attached to the bottom surface 6251 of the retention
matrix 6250. In
certain embodiments, the layer 6770 and/or the retention matrix 6250 can
comprise retention
features which can be configured to retain the layer 6770 to the retention
matrix 6250. In at least
one embodiment, at least one adhesive can be utilized to adhere the layer 6770
to the retention
matrix 6250. In any event, the layer 6770 can comprise a bottom, or tissue-
contacting, surface
6773 which can be configured to contact the tissue T when the retention matrix
6250 is moved
downwardly toward the staples 6220 to engage the retention apertures 6252 with
the staple legs
6221. In at least one such embodiment, the layer 6770 can be comprised of a
compressible
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material, such as a bioabsorbable foam, for example, which can be compressed
between the
surface 6251 of the retention matrix 6250 and the tissue T. In various
embodiments, the layer
6770 can further comprise one or more encapsulations, or cells, 6774 which can
be configured to
store at least one medicament therein. In certain embodiments, referring to
FIG. 149, the
encapsulations 6774 can be aligned, or at least substantially aligned, with
the retention apertures
6252 such that, when the staple legs 6221 are pushed through the tissue T and
the layer 6770, the
staple legs 6221 can puncture and/or otherwise rupture the encapsulations
6774. After the
encapsulations 6774 have been ruptured, the at least one medicament M stored
in the
encapsulations 6774 can flow out onto the tissue T. In at least one such
embodiment, the
medicament M can comprise a fluid which can flow or wick down the staple legs
6221 and treat
the tissue T that was just incised by the staple legs. As a result of the
above, the medicament
stored within the encapsulations 6774 can provide a localized treatment to the
tissue. In certain
embodiments, the encapsulations 6774 in the sheet 6770 can comprise different
medicaments
stored therein. For example, a first group of encapsulations 6774 can comprise
a first
medicament, or a first combination of medicaments, stored therein and a second
group of
encapsulations can comprise a different medicament, or a different combination
of medicaments,
stored therein. In various embodiments, the layer 6770 can be comprised of a
flexible silicone
sheet and the encapsulations 6774 can represent voids in the silicone sheet.
In at least one such
embodiment, the silicone sheet can comprise two layers that can be attached to
one another
wherein the encapsulations 6774 can be defined between the two layers. In
various
embodiments, the layer 6770 can comprise one or more thin sections or weakened
portions, such
as partial perforations, for example, which can facilitate the incision of the
layer 6770 and the
rupture of the encapsulations 6774 by the legs 6221. In certain embodiments,
at least a portion
of the encapsulations 6774 can be positioned within domes 6777, wherein the
domes 6777 can
extend upwardly from the sheet 6770. In at least one such embodiment, the
domes 6777 and/or
at least a portion of the encapsulations 6774 can be positioned within the
pockets 6201 formed
within the retention matrix 6250. In certain embodiments, the encapsulations
6774 may
comprise discrete cells which are unconnected to each other. In certain other
embodiments, one
or more of the encapsulations 6774 can be in fluid communication with each
other via one or
more passageways, conduits, and/or channels, for example, extending through
the layer 6770.
The disclosure of U.S. Patent No. 7,780,685, entitled ADHESIVE AND MECHANICAL
137
FASTENER, was issued on August 24, 2010.
[0561] In various embodiments, further to the above, a staple cartridge
comprising a cartridge
body, staples, and/or an alignment matrix therein can be loaded into a first
jaw of an end effector
and, similarly, a retention matrix and/or one or more covers can be loaded
into a second jaw o
the end effector. In certain embodiments, referring now to FIG. 151, an
instrument, such as
cartridge loader 6990, for example, can be used to insert two or more fastener
cartridges into an
end effector at the same. In at least one embodiment, the cartridge loader
6990 can comprise a
handle 6991 and a cartridge carrier 6992, wherein the cartridge carrier 6992
can comprise a first
retention portion configured to retain the cartridge body 6210 of the staple
cartridge 6200 thereto
and, in addition, a second retention portion configured to retain a cartridge
body 6980 which
supports, one, a plurality of protective caps 6270 therein and, two, a
retention matrix 6250 along
the bottom surface thereof, for example. In various embodiments, the first and
second retention
portions can each comprise one or more retention members configured to
releasably engage the
cartridge bodies 6210 and 6980. In use, referring now to FIGS. 152 and 153, an
end effector
can comprise a first, or bottom, jaw 6230 and a second, or top, jaw 6940,
wherein the staple
cartridge 6200 can be loaded into the first jaw 6230 and the cartridge body
6980 can be loaded
into the second jaw 6940. In various circumstances, the top jaw 6940 can be
rotated from an
open position (FIG. 152) to a closed position (FIG. 153) by an actuator 6235,
wherein the
operation of the actuator 6235 is described above and is not repeated herein
for the sake of
brevity. Once the top jaw 6940 is in its closed position, referring now to
FIG. 153, the distal end
6993 of the cartridge carrier 6992 can be inserted into the end effector such
that the staple
cartridge 6200 is slid through the distal end 6938 of the first jaw 6930 and
into a first attachment
portion, or channel, 6939 in the first jaw 6230. Similarly, the distal end
6993 of the cartridge
carrier 6992 can be inserted into the end effector such that the cartridge
body 6980 is slid
through the distal end 6948 of the second jaw 6940 and into a second
attachment portion, or
channel, 6949 in the second jaw 6940. A surgeon, or other clinician, holding
the handle 6991 of
the cartridge loader 6990 can push the staple cartridge 6200 and the cartridge
body 6980 through
the channels 6939 and 6949, respectively, until the staple cartridge 6200 and
the cartridge body
6980 are fully seated therein.
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[0562] As the staple cartridge 6200 and the cartridge body 6980 are being
seated, the staple
cartridge 6200 and the cartridge body 6980 can each engage one or more
retention portions in
their respective jaws 6230 and 6940, as described in greater detail further
below. In any event,
once the staple cartridge 6200 and the cartridge body 6980 have been seated,
referring now to
FIG. 154, the cartridge loader 6990 can be detached from the staple cartridge
6200 and the
cartridge body 6980 and removed from the end effector. In at least one such
embodiment, the
retention force holding the staple cartridge 6200 in the first jaw 6230 can be
greater than the
retention force holding the staple cartridge 6200 to the cartridge carrier
6992 such that, as the
cartridge carrier 6992 is pulled distally out of the end effector, the staple
cartridge 6200 can
remain behind in the first jaw 6230. Similarly, the retention force holding
the cartridge body
6980 in the second jaw 6940 can be greater than the retention force holding
the cartridge body
6940 to the cartridge carrier 6992 such that, as the cartridge carrier 6992 is
pulled distally out of
the end effector, the cartridge body 6940 can remain behind in the second jaw
6940. Once the
cartridge loader 6990 has been removed from the end effector, the loaded first
jaw 6230 and the
loaded second jaw 6940 can be positioned relative to the tissue T that is to
be stapled. Referring
now to FIG. 155, the second jaw 6940 can be moved from an open position (FIG.
154) to a fired
position (FIG. 155) in order to engage the retention matrix 6250 and the
plurality of protective
caps 6270 carried by the cartridge body 6980 with the staples 6220 positioned
within the staple
cartridge 6200.
[0563] Referring now to FIGS. 156 and 157, the second jaw 6940 can here-opened
and the
plurality of protective caps 6270 and the retention matrix 6250 can detach
from the cartridge
body 6980 such that the caps 6270 and the retention matrix 6250 can remain
engaged with the
tissue T and the staple cartridge 6200. In at least one embodiment, the
cartridge body 6980 can
comprise a plurality of pockets in which the plurality of caps 6270 can be
removably positioned
and one or more retention slots configured to removably retain the retention
matrix 6250 thereto.
In various embodiments, the retention members of the second jaw 6940 engaged
with the
cartridge body 6980 can retain the cartridge body 6980 in the second jaw 6940
after the second
jaw 6940 has been opened. In certain embodiments, the cartridge body 6980 can
be configured
to tear as the second jaw 6940 is opened such that a portion of the cartridge
body 6980 is
implanted with the caps 6270 and the retention matrix 6250 and a portion of
the cartridge body
6980 remains in the second jaw 6940. Similarly, referring again to FIGS. 156
and 157, the
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retention members of the first jaw 6230 engaged with the cartridge body 6210
can retain the
cartridge body 6210 in the first jaw 6230 after the second jaw 6940 has been
opened. In certain
embodiments, the cartridge body 6210 can be configured to tear as the first
jaw 6230 is pulled
away from the implanted cartridge 6200 such that a portion of the cartridge
body 6210 is
implanted with the staples 6220 and alignment matrix 6260 and a portion of the
cartridge body
6210 remains in the first jaw 6230. In various embodiments, referring now to
FIGS. 158-160, a
staple cartridge, such as staple cartridge 6900, for example, can comprise one
or more
longitudinal retention slots 6913 extending along the length of the cartridge
body 6910 which,
when the staple cartridge 6900 is inserted into a jaw 6930, for example, can
be configured to
receive one or more longitudinal retention rails 6916 extending from the jaw
6930 therein. In
use, in at least one embodiment, an end of the retention slots 6913 can be
aligned with the distal
ends of the retention rails 6916 before the staple cartridge 6900 is slid
through the distal end
6938 of the retention channel 6939, for example.
[0564] In various embodiments, referring again to FIG. 160, the jaw 6940 can
comprise two
retention channels 6949, wherein each retention channel 6949 can be configured
to receive a
cartridge body 6980 comprising a plurality of caps 6270 and a retention matrix
6250 therein. In
certain embodiments, each cartridge body 6980 can comprise one or more
longitudinal retention
shoulders 6917 which can be configured to be slid along one or more
longitudinal retention rails
6918 of the second jaw 6940 as the cartridge bodies 6980 are inserted into
their respective
retention channels 6949 in jaw 6940. In various embodiments, the retention
rails 6918 and the
retention shoulders 6917 can co-operate to retain the cartridge body 6980 in
the second jaw 6940
as the cartridge bodies 6980 are detached from the caps 6270 and the retention
matrix 6250
stored therein. In various embodiments, referring now to FIG. 159, the second
jaw 6940 can
further comprise one or more distal bumps, or retention members, 6915
extending therefrom
which can be configured to removably lock the cartridge bodies 6980 in their
respective retention
channels. In at least one such embodiment, the second jaw 6940 can comprise a
distal bump
6915 configured and positioned relative to each retention channel 6949 such
that each cartridge
body 6980 can flex around the bumps 6915 as the cartridge bodies 6980 are
being inserted into
the channels 6949 wherein, just as the cartridge bodies 6915 are being fully
seated in the
channels 6949, the distal ends of the cartridge bodies 6980 can clear and snap
over the bumps
6915. In order to remove the cartridge bodies 6980 after they have been
expended, as described
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above, the cartridge bodies 6980 can be pulled back over the bumps 6915 and
removed from the
retention channels 6949. Similar to the above, the first jaw 6930 can comprise
one or more distal
retention bumps 6914 extending therefrom which can be configured to be
received in one or
more retention grooves, or slots, 6912 (FIG. 158) in the cartridge body 6910
when the staple
cartridge 6900 has been fully seated.
[0565] In various embodiments, further to the above, a first fastener
cartridge comprising a
plurality of first fasteners positioned therein can be positioned in a first
jaw of a surgical
fastening device and a second fastener cartridge comprising a plurality of
second fasteners
positioned therein can be positioned in a second jaw of the surgical fastening
device. In use, the
first jaw and/or the second jaw can be moved toward the other in order to
engage the first
fasteners with the second fasteners and secure tissue therebetween. In certain
embodiments, the
first fastener cartridge and the second fastener cartridge can be engaged with
each other as the
first fasteners are engaged with the second fasteners. In at least one
embodiment, the body of the
first fastener cartridge can be comprised of a first compressible material and
the body of the
second fastener cartridge can be comprised of a second compressible material,
wherein the first
body and/or the second body can be compressed against the tissue being
fastened. After the
tissue has been fastened, the first jaw can be moved away from the implanted
first fastener
cartridge and the second jaw can be moved away from the implanted second
fastener cartridge.
Thereafter, the first jaw can be reloaded with another first fastener
cartridge, or the like, and the
second jaw can be reloaded with another second fastener cartridge, or the
like, and the surgical
fastening instrument can be reused. While staples can be used in some
embodiments, other
embodiments are envisioned comprising other types of fasteners, such as two-
part fasteners
which are locked together when they are engaged with one another, for example.
In at least one
such embodiment, the first fastener cartridge can comprise a first storage
portion for storing the
first fastener portions and the second fastener cartridge can comprise a
second storage portion for
storing the second fastener portions. In various embodiments, the fastening
systems described
herein can utilize fasteners comprising any suitable type of material and/or
form. In certain
embodiments, the fasteners can comprise penetrating members. Such penetrating
members
could be comprised of a polymer, a composite, and/or a multi-layered
substrate, for example. An
example of a multi-layered substrate could be a wire or a sheet substrate with
an elastomeric or
polymeric coating. It could be a thin sheet formed such that penetrating
members are oriented
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perpendicular, or at least substantially perpendicular, to the connecting
member. The penetrating
members could comprise a rectangular profile, semi-circular profile, and/or
any beam profile. In
various embodiments, the fasteners described herein can be manufactured
utilizing any suitable
process, such as a wire extruding process, for example. Another possibility is
the use of
microfabrication to create hollow penetrating members. These penetrating
members could be
fabricated from a process which is different than a wire extruded process and
could use a
combination of materials.
[0566] As described above, the tips of staple legs protruding through a
retention matrix can be
covered by one or more caps and/or covers. In certain embodiments, the tips of
the staple legs
can be deformed after they have been inserted through the retention matrix. In
at least one
embodiment, a jaw holding the retention matrix can further comprise anvil
pockets positioned
above and/or aligned with the retention apertures which can be configured to
deform the staple
legs as they protrude above the retention matrix. In various embodiments, the
staple legs of each
staple can be curled inwardly toward each other and/or toward the center of
the staple, for
example. In certain other embodiments, one or more of the staple legs of a
staple can be curled
outwardly away from the other staple legs and/or away from the center of the
staple. In various
embodiments, regardless of the direction in which the staple legs are curled,
the tips of the staple
legs can contact the body of the retention matrix and may not re-enter the
tissue that has been
fastened by the staples. In at least one embodiment, the deformation of the
staple legs after they
have passed through the retention matrix can lock the retention matrix in
position.
[0567] In various embodiments, referring now to FIGS. 161 and 162, a surgical
stapling
instrument, such as surgical stapler 7000, for example, can comprise a first
jaw 7030 and a
second jaw 7040, wherein the second jaw 7040 can be moved toward and away from
the first jaw
7030 by the movement of actuator 6235. The operation of actuator 6235 is
described above and
is not repeated herein for the sake of brevity. In various embodiments, the
first jaw 7030 can
comprise a distal end 7031 and a proximal end 7032, wherein the first jaw 7030
can define a
channel extending between the distal end 7031 and the proximal end 7032 which
is configured to
receive a staple cartridge. For the purposes of illustration, the cartridge
body of such a staple
cartridge is not depicted in FIG. 161, although such a staple cartridge can
comprise a cartridge
body, staples 6220 positioned within the cartridge body, and staple drivers
7012 positioned
underneath the staples 6220. In certain embodiments, although not illustrated
in FIG. 161 for the
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sake of clarity, the second jaw 7040 can be configured to hold a retention
matrix, such as
retention matrix 6250, for example, over the staples 6220 and/or move the
retention matrix into
engagement with the legs of the staples 6220 as described above. In at least
one embodiment,
the surgical stapler 7000 can further comprise a sled 7010 positioned in the
first jaw 7030 which
can be slid from the distal end 7031 of the first jaw 7030 toward the proximal
end 7032, for
example, and lift the staple drivers 7012, and the staple 6220 supported
thereon, toward the
retention matrix and the second jaw 7040. In various other embodiments, the
sled 7010 can be
moved from the proximal end 7032 toward the distal end 7031 in order to deploy
the staples
6020, for example. In at least one embodiment, the sled 7010 can comprise one
or more inclined
ramps, or cams, 7011 which can be configured to slide underneath the staple
drivers 7012 and lift
the staple drivers 7012 upwardly. In various embodiments, the surgical stapler
7000 can further
comprise a pull, or push, rod operably coupled to the sled 7010 which can be
moved proximally
and/or distally by an actuator located on a handle and/or shaft of the
surgical stapler 7000, for
example.
[0568] In various embodiments, referring again to FIG. 161, the second jaw
7040 of the
surgical stapler 7000 can comprise a frame 7041, a distal end 7048, and a
proximal end 7049
positioned opposite the distal end 7048. In certain embodiments, the second
jaw 7040 can
further comprise a guide system comprising one or more guide rails, such as
guide rails 7045 and
7046, for example, extending along the longitudinal axis of the frame 7041
which, as described
in greater detail further below, can be configured to guide one or more
anvils, or cams, which
can engage and deform the staple legs of the staples 6220 after the staple
legs 6221 of the staples
6220 have passed through the retention matrix. In at least one such
embodiment, the guide rails
7045 and 7046 can comprise a guide wire or cable which extends along a top
portion or surface
of the frame 7041, around a distal post 7047, and back along the top portion
or surface of the
frame 7041, for example. In various embodiments, as mentioned above and
referring primarily
now to FIGS. 163 and 165, the second jaw 7040 can further comprise one or more
anvils, or
cams, such as first anvil 7050 and second anvil 7060, for example, which can
be moved
longitudinally along the second jaw 7040 in order to deform the legs of the
staples 6220 after
they have passed through the retention matrix. In at least one embodiment, the
surgical stapler
7000 can further comprise a first anvil driver, or actuator, 7051 connected to
and/or operably
coupled to the first anvil 7050 which can be configured to pull the first
anvil 7050 proximally
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and/or push the first anvil 7050 distally. Similarly, in at least one
embodiment, the surgical
stapler 7000 can further comprise a second anvil driver, or actuator,
connected to and/or operably
coupled to the second anvil 7060 which can be configured to push the second
anvil 7060 distally
and/or pull the second anvil 7060 proximally. In various embodiments, the
first anvil 7050 can
comprise guide slots 7052 and the second anvil 7060 can comprise guide slots
7062 which can
each be configured to slidably receive guide rail 7045 or guide rail 7046
therein. In at least one
such embodiment, the guide rails 7045 and 7046 can be closely received within
the guide slots
7052 and 7062 such that relative lateral, or side-to-side, movement
therebetween can be
prevented, or at least limited.
[0569] In certain embodiments, further to the above, the first anvil 7050 can
be pulled
proximally and the second anvil 7060 can be pulled distally. In at least one
embodiment,
referring to FIG. 161, the guide rails 7045 and 7046 and the distal post 7047
can comprise a
pulley system configured to pull the second anvil 7060 distally and/or pull
the second anvil 7060
proximally. In at least one such embodiment, the guide rail 7045 and the guide
rail 7046 can
comprise a continuous wire or cable extending around the distal post 7047,
wherein a portion of
the continuous wire can be pulled in order to cycle the wire around the distal
post 7047. In
various embodiments, the guide rail 7046, for example, can be mounted to the
second anvil 7060
such that, when the continuous cable is cycled in a first direction, the
second anvil 7060 can be
pulled distally toward the distal end 7048 of the jaw 7040 and, when the
continuous cable is
cycled in a second, or opposite, direction, the second anvil 7060 can be
pulled proximally toward
the proximal end 7049. In at least one embodiment, referring now to FIG. 163,
the guide rail
7046 can be secured within a guide slot 7062 such that a pulling force can be
transmitted
therebetween. In at least one such embodiment, the guide rail 7045 can be
configured to slide
within the other guide slot 7062. In various embodiments, the first anvil 7050
may operate
independently of the second anvil 7060 and the pulley system and the guide
slots 7052 defined in
the first anvil 7050 may be configured to slidably receive the guide rails
7045 and 7046 such that
relative movement is permitted therebetween. In various embodiments, the
continuous cable
comprising guide rails 7045 and 7046 can be sufficiently flexible in order to
accommodate the
opening and closing of the top jaw 7040. The continuous cable can also be
sufficiently flexible
in order to accommodate the vertical movement of the second anvil 7060 toward
and away from
the bottom jaw 7030, which is described in greater detail further below.
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[0570] In various embodiments, referring again to FIGS. 163 and 165, the first
anvil 7050 can
comprise cam followers 7055 extending therefrom which can be configured to
ride in one or
more cam slots, or guide slots, such as cam slot 7070 (FIG. 166), for example,
defined in the
frame 7041 of the second jaw 7040. More particularly, in at least one
embodiment, the frame
7041 can comprise a first cam slot 7070 extending longitudinally along a first
side of the frame
7041 and a second cam 7070 extending longitudinally along a second, or
opposite, side of the
frame 7041, wherein the cam followers 7055 extending from a first side of the
first anvil 7050
can ride in the first cam slot 7070 and the cam followers 7055 extending from
a second side of
the first anvil 7050 can ride in the second cam slot 7070. In at least one
such embodiment, the
contours of each cam slot 7070 can be identical, or at least substantially
identical, and can be
aligned, or at least substantially aligned, with one another. Similarly, in
various embodiments,
the second anvil 7060 can comprise cam followers 7065 extending therefrom
which can be
configured to ride in the cam slots 7070 (FIG. 166) defined in the frame 7041
of the second jaw
7040. More particularly, in at least one embodiment, the cam followers 7065
extending from a
first side of the second anvil 7060 can ride in the first cam slot 7070 and
the cam followers 7065
extending from a second side of the second anvil 7060 can ride in the second
cam slot 7070. In
use, the cam followers 7055 of the first anvil 7050 and the cam followers 7065
of the second
anvil 7060 can slide within the cam slots 7070 such that first anvil 7050 and
the second anvil
7060 follow the contours of the cam slots 7070 as the first anvil 7050 and the
second anvil 7060
are pulled proximally and/or pushed distally. In various embodiments, each cam
slot 7070 can
comprise a plurality of dwell, or upper, portions 7071 and a plurality of
driver, or lower, portions
7072 which can be configured to move the anvils 7050 and 7060 vertically,
i.e., toward and away
from the bottom jaw 7030, at the same time that the anvils 7050 and 7060 are
being moved
longitudinally, i.e., between the distal end 7048 and the proximal end 7049 of
the frame 7041, as
described in greater detail further below.
[0571] When the surgical stapler 7000 is in an unfired condition, referring to
FIG. 166, the first
anvil 7050 can be positioned at the distal end 7048 of the frame 7041 and the
second anvil 7060
can be positioned at the proximal end 7049 of the frame 7041; furthermore,
referring now to
FIG. 167, the staples 6220 positioned in the first jaw 7030 may not yet be
inserted into the tissue
T and/or the retention matrix positioned thereabove when the surgical stapler
7000 is in an
unfired condition. In use, referring now to FIG. 168, the staples 6220 can be
driven upwardly
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within the staple cavities 7033 of a staple cartridge by the staple drivers
7012 and, in addition,
the first anvil 7050 can be moved proximally from the distal end 7048 of the
frame 7041 toward
the distal end 7049 in order to engage the staple legs 6221 of the staples
6220. In at least one
embodiment, the staples 6220 can be driven upwardly before the first anvil
7050 is engaged with
the staple legs 6221 thereof. In various embodiments, all of the staples 6220
may be deployed
upwardly by the sled 7010 before the first anvil 7050 is advanced into contact
with the staple
legs 6221 or, alternatively, the sled 7010 may be moved proximally at the same
time that the first
anvil 7050 is moved proximally, although the sled 7010 may sufficiently lead
the first anvil 7050
in order to deploy the staples 6220 ahead of the first anvil 7050. In various
embodiments, as
illustrated in FIG. 168, the cam slots 7070 can be configured and arranged
such that the forming
surfaces, such as forming, or camming, surfaces 7053 and 7054, for example, of
the first cam
7050 can contact at least some of the staple legs 6221 when the first cam 7050
is passing through
a dwell, or upper, position. In various circumstances, the cam followers 7055
of the first anvil
7050 can each be positioned in a dwell portion 7071 of the cam slots 7070 such
that the forming
surfaces 7053 and 7054 are in a raised position and such that the staple legs
6221 are only
partially deformed when the anvil 7050 passes thereby in the dwell position.
As the first cam
7050 is moved further along the cam slots 7070, as illustrated in FIG. 169,
the cam followers
7055 of the first anvil 7050 can be driven into driven, or lower, portions
7072 of the cam slots
7070 such that the forming surfaces 7053 and 7054 are moved vertically
downwardly toward the
staple legs 6021 in order to drive the staple legs 6021 into their finally
formed configurations.
Thereafter, as the first anvil 7050 is progressed further along the cam slots
7070, the first anvil
7050 can be driven vertically upwardly into another set of dwell portions 7071
of the cam slots
7070. As illustrated in FIGS. 168 and 169, the reader will note that the first
anvil 7050 may only
engage some of the staple legs and not others. In at least one such
embodiment, the first anvil
7050 can be configured to only deform a group of staple legs comprising the
distal staple legs
6221 of the staples 6220, for example. In at least one such embodiment, the
first anvil 7050 can
be configured to deform the distal staple legs 6221 toward the center of the
staples 6220. In
various embodiments, each proximal staple leg 6221 can be contacted twice by
the first anvil
7050, i.e., by a first forming surface 7053 and by a second forming surface
7054 aligned with the
first forming surface 7053. In at least one such embodiment, the first forming
surfaces 7053 can
deform the distal staple legs 6221 into a partially-deformed configuration
when the first anvil
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7050 is in a dwell, or upper, position and the second forming surfaces 7054
can deform the distal
staple legs 6221 into a fully-formed configuration when the first anvil 7050
is moved into a
driven, or lower, position. In various embodiments, referring now to FIGS. 163
and 164, the first
anvil 7050 can comprise a plurality of first forming surfaces 7053 and a
plurality of second
forming surfaces 7054 in order to deform the distal staple legs 6221 of
staples 6220 when the
staple legs 6221 are arranged in more than one row or line. In various
embodiments, as
described in greater detail further below, the proximal staple legs 6221 of
the staples 6020 can be
deformed by the second anvil 7060, for example.
[0572] In various embodiments, further to the above, the first anvil 7050 can
be moved from
the distal end 7048 of the frame 7041 to the proximal end 7049 in order to
deform all of the
distal staple legs 6221 of the staples 6220. As the reader will note, the
first anvil 7050 can be
moved up and down relative to the undeformed proximal staple legs 6221 and, in
order to
accommodate such relative movement, in various embodiments, the first anvil
7050 can
comprise one or more clearance slots 7057 (FIG. 165) which can be configured
to receive the
unbent proximal staple legs 6221 as the first anvil 7050 bends the distal
staple legs 6221.
Similarly, referring again to FIG. 163, the second anvil 7060 can comprise a
clearance slot 7067
which can be configured to accommodate the vertical movement of the first cam
actuator 7051
which moves up and down as the first anvil 7050 is moved between its dwell and
driven
positions as described above. After all of the distal staple legs 6221 have
been bent, in at least
one embodiment, the second anvil 7060 can be moved from the proximal end 7049
of the frame
7041 to the distal end 7048 by the anvil actuator 7061. Similar to the above,
referring now to
FIG. 170, the cam followers 7065 of the second anvil 7060 can slide within the
cam slots 7070
such that the second anvil 7060 is moved between dwell, or upper, positions
and driven, or
lower, positions in order to deform the proximal staple legs 6221 inwardly
toward the centers of
the staples 6220, for example. Similar to the above, the second anvil 7060 can
comprise a
plurality of first forming, or camming, surfaces 7063 and a plurality of
second forming, or
camming, surfaces 7064 which can each be configured to at least partially
deform and/or
completely deform one or more of the proximal staple legs 6021. Referring
again to FIG. 164,
the second anvil 7060 can comprise a plurality of first forming surface 7063
and a plurality of
second forming surfaces 7064 which can be configured to deform the proximal
staple legs 6221
of staples 6220 arranged in a plurality of rows, or lines, for example. As
also illustrated in FIG.
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164, the first forming surfaces 7063 and the second forming surfaces 7064 of
the second anvil
7060 may not be aligned with the first forming surfaces 7053 and the second
forming surfaces
7054 of the first anvil 7050 wherein, as a result, the proximal legs 6221 of
the staples 6220 may
be positioned in different rows, or lines, than the distal legs 6221 of the
staples 6220. As the
reader will also note, the second anvil 7060 can push the first anvil 7050 as
the second anvil
7060 is moved distally. In at least one such embodiment, the second anvil 7060
can push the
first anvil 7050 back into the distal end 7048 of the frame 7041 such that the
first anvil 7050 can
be returned to its initial, or unfired, position After all of the proximal
staple legs 6221 of the
staples 6220 have been deformed, the second anvil 7060 can be retracted
proximally and
returned to its initial, or unfired, position. In this way, the surgical
stapler 7000 can be reset such
that a new staple cartridge can be positioned in the first jaw 7030 and a new
retention matrix can
be positioned in the second jaw 7040 in order to use the surgical stapler 7000
once again.
[0573] In various embodiments, as described above, a surgical stapler can
comprise two or
more anvils which can travel longitudinally in order to engage the legs of a
plurality of staples in
a transverse direction. In certain embodiments, a surgical stapler can
comprise an anvil which is
moved proximally, for example, in order to deform a first group of staple legs
and distally, for
example, in order to deform a second group of staple legs. In at least one
such embodiment,
such an anvil can comprise forming surfaces facing proximally and forming
surfaces facing
distally, for example.
[0574] In various embodiments, referring now to FIG. 171, an anvil, such as
anvil 7140, for
example, can comprise a bottom, or tissue-contacting, surface 7141 and a
plurality of forming
pockets 7142 defined therein. In at least one embodiment, the anvil 7140 can
comprise more
than one plate, such as pocket plates 7143, for example, which can be welded
into a frame 7144.
In at least one such embodiment, each pocket plate 7143 can be positioned in a
plate channel
7145 in the frame 7144 and welded to the frame 7144 through a weld slot 7146
extending
through the frame 7144 in order to form a longitudinal weld 7147. In various
circumstances, the
longitudinal weld 7147 can comprise a continuous weld extending along the
entire length of the
weld slot 7146 or a series of spaced-apart spot welds extending along the
length thereof, for
example. In various embodiments, each pocket plate 7143 can comprise two or
more plate
portions that have been welded together. In at least one such embodiment, each
pocket plate
7143 can comprise a first plate portion 7143a and a second plate portion 7143b
which can be
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welded together along a seam 7148. In various embodiments, the first plate
portion 7143a and
the second plate portion 7143b of each plate 7143 can be welded together
before the plates 7143
are welded into the plate channels 7145 in the frame 7144. In at least one
such embodiment, the
first plate portion 7143a and the second plate portion 7143b can comprise co-
operating profiles,
such as the toothed profiles illustrated in FIG. 171, for example, which can
be fitted together to
form a tight seam 7148. In at least one embodiment, each plate 7143 can
comprise a height of
approximately .02", for example, which can be taller than the depth of the
plate channels 7145
such that the tissue-contacting surfaces 7141 thereof extend from the frame
7044 of the anvil
7040. In certain embodiments, referring now to FIG. 172, the plates 7143 can
be connected
together by at least one weld 7149 at the distal ends of the plates 7143, for
example.
[0575] As illustrated in FIGS. 171 and 172, each pocket plate 7143 can
comprise a plurality of
forming pockets 7142 defined therein. In various embodiments, the forming
pockets 7142 can
be formed in the plates 7143 by any suitable manufacturing process, such as a
grinding process
and/or electrode-burning process, for example. In at least one such
embodiment, referring now
to FIGS. 173 and 174, each forming pocket 7142 can be manufactured by first
forming a deep
well 7150, then forming an arcuate or curved surface 7151 surrounding the deep
well 7150, and
then forming a staple leg guide groove 7152 in the curved surface 7151, for
example. In various
other embodiments, these steps can be performed in any suitable order. In
various embodiments,
referring now to FIG. 175, the staple forming pockets 7142 can be formed such
that the inner
edges 7153 of the forming pockets are separated by a consistent, or at least
substantially
consistent, gap 7154. In at least one such embodiment, the gap 7154 can be
approximately
.008", for example. Furthermore, in at least one such embodiment, the forming
pockets 7142 can
be positioned along two or more rows, or lines, the centerlines of which can
be separated by a
consistent, or at least substantially consistent, spacing 7155. In at least
one such embodiment,
the spacing 7155 between the centerlines can be approximately .035", for
example. In various
embodiments, referring again to FIG. 175, each forming pocket 7142 can taper
between a narrow
width 7156 and a wide width 7157. In at least one such embodiment, the narrow
width 7156 can
be approximately .045" and the wide width 7157 can be approximately .075", for
example. In
various embodiments, the plates 7143 can be comprised of the same material as
the frame 7144.
In at least one such embodiment, the plates 7143 and the frame 7144 can both
be comprised of
stainless steel, such as a 300 series or a 400 series stainless steel, for
example, and/or titanium,
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for example. In various other embodiments, the plates 7143 and the frame 7144
can be
comprised of different materials. In at least one such embodiment, the plates
7143 can be
comprised of a ceramic material, for example, and the frame 7144 can be
comprised of a
stainless steel and/or titanium, for example. In various circumstances,
depending on the
materials used, at least one brazing process could be used to secure the
plates 7143 in the frame
7144 in addition to or in lieu of the welding processes described above, for
example.
[0576] In various embodiments, referring now to FIGS. 176-178, an anvil 7240
can comprise a
frame 7244 and a plurality of pocket plates 7243 which can be inserted into
the frame 7244.
Similar to the above, each pocket plate 7243 can comprise a plurality of
forming pockets 7242
defined therein. In at least one embodiment, the anvil frame 7244 can comprise
retention slots
7246 defined therein which can each be configured to receive a retention rail
7247 extending
from a pocket plate 7243. In order to assemble the pocket plates 7243 to the
anvil frame 7244,
the side walls 7245 of the anvil frame 7244 can be flexed or splayed
outwardly, as illustrated in
FIG. 177, in order to widen the retention slots 7246 such that each retention
slot 7246 can
receive a retention rail 7247 of a pocket plate 7243 therein. Once the
retention rails 7247 have
been positioned in the retention slots 7246, the side walls 7245 can be
released, as illustrated in
FIG. 178, thereby allowing the frame 7244 to resiliently contract and/or
return to its unflexed
state. In such circumstances, the retention slots 7246 can contract and
thereby capture the
retention rails 7247 therein. In certain embodiments, the retention rails 7247
and/or the retention
slots 7246 can comprise one or more co-operating tapered surfaces which, after
the flexed
retention slots 7246 have been released, can form a taper-lock engagement
which can retain the
retention rails 7247 in the retention slots 7246. Similar to the above, the
pocket plates 7243 can
be comprised of the same material as or a different material than the frame
7244. In at least one
such embodiment, the plates 7243 can be comprised of a ceramic material, for
example, and the
frame 7244 can be comprised of a stainless steel and/or titanium, for example.
In various
circumstances, depending on the materials used, at least one brazing process
and/or at least one
welding process, for example, could be used to secure the plates 7243 in the
frame 7244.
[0577] In FIGS. 179 and 180, a surgical stapling and severing instrument 8010
can comprise an
anvil 8014 which may be repeatably opened and closed about its pivotal
attachment to an
elongate staple channel 8016. A staple applying assembly 8012 can comprise the
anvil 8014 and
the channel 8016, wherein the assembly 8012 can be proximally attached to the
elongate shaft
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8018 forming an implement portion 8022. When the staple applying assembly 8012
is closed, or
at least substantially closed, the implement portion 8022 can present a
sufficiently small cross-
section suitable for inserting the staple applying assembly 8012 through a
trocar. In various
embodiments, the assembly 8012 can be manipulated by a handle 8020 connected
to the shaft
8018. The handle 8020 can comprise user controls such as a rotation knob 8030
that rotates the
elongate shaft 8018 and staple applying assembly 8012 about a longitudinal
axis of the shaft
8018. A closure trigger 8026, which can pivot in front of a pistol grip 8036
about a closure
trigger pin 8152 (FIG. 181) engaged laterally across the handle housing 8154,
can be depressed
to close the staple applying assembly 8012. In various embodiments, a closure
release button
8038 can be outwardly presented on the handle 8020 when the closure trigger
8026 is clamped
such that the release button 8038 can be depressed to unclamp the closure
trigger 8026 and open
the staple applying assembly 8012, as described in greater detail below. A
firing trigger 8034,
which can pivot in front of the closure trigger 8026, can cause the staple
applying assembly 8012
to simultaneously sever and staple tissue clamped therein. In various
circumstances, as described
in greater detail below, multiple firing strokes can be employed using the
firing trigger 8034 to
reduce the amount of force required to be applied by the surgeon's hand per
stroke. In certain
embodiments, the handle 8020 can comprise rotatable right and/or left
indicator wheels 8040,
8041 (FIG. 181) which can indicate the firing progress. For instance, full
firing travel may
require three full firing strokes of firing trigger 8034 and thus the
indicator wheels 8040, 8041
can rotate up to one-third of a revolution each per stroke of firing trigger
8034. As described in
greater detail below, a manual firing release lever 8042 can allow the firing
system to be
retracted before full firing travel has been completed, if desired, and, in
addition, the firing
release lever 8042 can allow a surgeon, or other clinician, to retract the
firing system in the event
that the firing system binds and/or fails.
[0578] With reference to FIGS. 179 and 181, the elongate shaft 8018 can
comprise an outer
structure including a longitudinally reciprocating closure tube 8024 that
pivots the anvil 8014
toward its close position in response to the proximal depression of the
closure trigger 8026 of
handle 8020. The elongate channel 8018 can be connected to the handle 8020 by
a frame 8028
(FIG. 181) that is internal to the closure tube 8024. The frame 8028 can be
rotatably engaged to
the handle 8020 so that the rotation of the rotation knob 8030 (FIG. 179) can
rotate the
implement portion 8022. With particular reference to FIG. 181, the rotation
knob 8030 can be
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comprised of two half-shells which can include one or more inward projections
8031 that can
extend through one or more elongate side openings 8070 in the closure tube
8024 and engage the
frame 8028. As a result of the above, the rotation knob 8030 and the frame
8028 can be rotated
together, or synchronously, such that the rotated position of knob 8030
determines the rotated
position of the implement portion 8022. In various embodiments, the
longitudinal length of the
longer opening 8070 is sufficiently long to allow the longitudinal closure
motion, and opening
motion, of the closure tube 8024. With regard to generating the closure motion
of closure tube
8024, referring primarily to FIGS 181 and 183, an upper portion 8160 of the
closure trigger
8026 can push forward a closure yoke 8162 via a closure link 8164. The closure
link 8164 is
pivotally attached at its distal end by a closure yoke pin 8166 to the closure
yoke 8162 and is
pivotally attached at its proximal end by a closure link pin 8168. In various
embodiments, the
closure trigger 8026 can be urged to an open position by a closure trigger
tension spring 8246
that is connected proximally to the upper portion 8160 of the closure trigger
8026 and a handle
housing 8154 formed by right and left half shells 8156, 8158. The tension
force applied by the
tension spring 8246 can be overcome by a closing force applied to the closure
trigger 8026 in
order to advance the yoke 8162, closure link 8164, and the closure tube 8024
distally.
[0579] As the closure trigger 8026 is actuated, or depressed, as described
above, the closure
release button 8038 can be positioned such that the surgeon, or other
clinician, can push the
closure release button 8038, if desired, and allow the closure trigger 8026,
and the rest of the
surgical instrument, to return to an unactuated state. In various embodiments,
the closure release
button 8038 can be connected to a pivoting locking arm 8172 by a central
lateral pivot 8173 such
that motion can be transferred between the release button 8038 and the locking
arm 8172.
Referring again to FIG. 181, a compression spring 8174 can bias the closure
release button 8038
proximally, i.e., clockwise about the central lateral pivot 8173 as viewed
from the right and the
upper portion 8160 of the closure trigger 8026 can include a proximal crest
8170 with an aft
notch 8171. As the closure trigger 8026 is depressed, the pivoting locking arm
8172 can ride
upon the proximal crest 8170 and when the closure trigger 8026 reaches its
fully depressed
position, it should be appreciated that the aft notch 8171 is presented below
the pivoting locking
arm 8172 which drops into and locks against the aft notch 8171 under the
urging of the
compression spring 8174. At such point, manual depression of the closure
release button 8038
rotates the pivoting locking arm 8172 upward and out of aft notch 8171 thereby
unlocking the
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closure trigger 8026 and allowing the closure trigger 8026 to be returned to
its unclamped
position.
[0580] Once the closure trigger 8026 is proximally clamped, as discussed
above, the firing
trigger 8034 can be drawn toward the pistol grip 8036 in order to advance a
firing rod 8032
distally from the handle 8020. In various embodiments, the firing trigger 8034
can pivot about a
firing trigger pin 8202 that laterally traverses and is engaged with the right
and left half shells
8156, 8158 of the handle 8020. The firing trigger 8034, when actuated, can
advance a linked
transmission firing mechanism 8150. The linked transmission firing mechanism
8150 can be
urged into a retracted, unfired, position by a spring 8184 that is, one,
attached to the pistol grip
8036 of the handle 8020 and, two, attached to one of the links, for example,
of the linked
transmission firing mechanism 8150 as described in greater detail below. The
spring 8184 can
comprise a nonmoving end 8186 connected to the housing 8154 and a moving end
8188
connected to a proximal end 8190 of a steel band 8192. A distally-disposed end
8194 of the steel
band 8192 can be attached to an attachment feature 8195 on a front link 8196a
of a plurality of
links 8196a -8196d that form a linked rack 8200. Linked rack 8200 can be
flexible such that it
can readily retract into the pistol grip 8036 and minimize the length of the
handle 8020 and yet
form a straight rigid rack assembly that may transfer a significant firing
force to and/or through
the firing rod 8032. As described in greater detail below, the firing trigger
8034 can be engaged
with a first link 8196a during a first actuation of the firing trigger 8034,
engaged with a second
link 8196b during a second actuation of the firing trigger 8034, engaged with
a third link 8196c
during a third actuation of the firing trigger 8034, and engaged with a fourth
link 8196d during a
fourth actuation of the firing trigger 8034, wherein each actuation of the
firing trigger 8034 can
advance the linked rack 8200 distally an incremental amount. In various
embodiments, further to
the above, the multiple strokes of firing trigger 1034 can rotate the right
and left indicator gauge
wheels 1040, 1041 to indicate the distance in which the linked rack 8200 has
been advanced.
[0581] Referring now to FIGS. 181 and 183, an anti-backup mechanism 8250 can
prevent the
combination tension/compression spring 8184 from retracting the linked rack
8200 between
firing strokes. In various embodiments, a coupling slide tube 8131 abuts the
first link 8196a and
connects to the firing rod 8032 to communicate the firing motion. The firing
rod 8032 extends
proximally out of a proximal end of the frame 8028 and through a through hole
8408 of an anti-
backup plate 8266. The through hole 8408 is sized to slidingly receive the
firing rod 8032 when
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perpendicularly aligned but to bind when tipped. A lower tab attachment 8271
extends
proximally from a lower lip of the proximal end of the frame 8028, extending
through an
aperture 8269 on a lower edge of the anti-backup plate 8266. This lower tab
attachment 8271
draws the lower portion of the anti-backup plate 8266 proximate to the frame
8028 so that the
anti-backup plate 8266 is perpendicular when the firing rod 8032 is distally
advanced and
allowed to tip top aft into a binding state when the firing rod 8032 attempts
to retract. An anti-
backup compression spring 8264 is distally constrained by the proximal end of
the frame 8028
and proximally abuts a top portion of the anti-backup plate 8266, biasing the
anti-backup plate
8266 to a locking state. Opposing the spring bias, an anti-backup cam tube
8268 slidingly
encompasses the coupling slide tube 8131 and abuts the anti-backup plate 8266.
A proximally
projecting anti-backup yoke 8256 attached to the anti-backup cam tube 8268
extends overtop of
the closure yoke 8162.
[0582] Referring to FIG. 181, a link triggered automatic retraction mechanism
8289 is
incorporated into the surgical stapling and severing instrument 8010 to cause
knife retraction at
the end of full firing travel. To that end, the distal link 8196d includes a
tang 8290 that projects
upwardly when the distal link 8196d is advanced into rack channel 8291 (FIG.
181) formed in
the closure yoke 8162. This tang 8290 is aligned to activate a bottom proximal
cam 8292 on an
anti-backup release lever 8248 (FIG. 186). With particular reference to FIGS.
186 and 187,
structures formed in the right and left half shells 8156, 8158 constrain
movement of the anti-
backup release lever 8248. A pin receptacle 8296 and circular pin 8293 formed
respectively
between right and left half shells 8156, 8158 is received through a
longitudinally elongate
aperture 8294 formed in the anti-backup release lever 8248 distal to the
bottom proximal cam
8292, thus allowing longitudinal translation as well as rotation about the
circular pin 8293. In the
right half shell 8156, a proximally open channel 8295 includes a proximal
horizontal portion
8295a that communicates with an upwardly and distally angled portion 8295b
that receives a
rightward aft pin 8297 (FIG. 187) near the proximal end of the anti-backup
release lever 8248,
thus imparting an upward rotation as the anti-backup release lever 8248
reaches the distal most
portion of its translation. A blocking structure formed in the right half
shell 8156 proximal to the
anti-backup release lever 8248 prevents proximal movement thereof once
assembled to maintain
rightward aft pin 8297 in the proximally open channel 8295.
[0583] Further to the above, as depicted in FIGS. 187 and 188, a distal end
8254 of the anti-
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backup release lever 8248 thus is urged distally and downwardly, causing a
rightward front pin
8298 to drop into distally open step structure 8299 formed in the right half
shell 8156, which is
urged into this engagement by a compression spring 8300 (FIG. 188) hooked to a
leftward hook
8301 on the anti-backup release lever 8248 between the rightward front pin
8298 and the
longitudinally elongate aperture 8294. The other end of the compression spring
8300 is attached
to a hook 8302 (FIGS. 186, 188, 189) formed in the right half shell 8156 in a
more proximal and
lower position just above the closure yoke 8266. The compression spring 8300
thus pulls the
distal end 8254 of the anti-backup release lever 8248 down and aft, which
results in the
rightward front pin 8298 locking into the distally open step structure 8299
when distally
advanced. Thus, once tripped, referring to FIG. 189, the anti-backup release
lever 8248 remains
forward holding the anti-backup plate 8266 perpendicularly and thus allowing
the linked rack
8200 to be refracted. When the closure yoke 8266 is subsequently retracted
when unclamping the
end effector 8012, an upwardly projecting reset tang 8303 on the closure yoke
8266 contacts a
bottom distal cam 8305 of the anti-backup release lever 8248, lifting the
rightward front pin 8298
out of the distally open step structure 8299 so that the anti-backup
compression spring 8264 can
proximally push the anti-backup cam tube 8268 and the anti-backup release
lever 8248 to their
retracted positions (FIG. 186).
[0584] In various embodiments, referring to FIGS. 179 and 189, the firing
trigger 8034 can be
operably engaged to the linked rack 8200 in any suitable manner. With
particular reference to
FIGS. 180 and 185, the firing trigger 8034 pivots about a firing trigger pin
8202 that is connected
to the housing 8154. An upper portion 8204 of the firing trigger 8034 moves
distally about the
firing trigger pin 8202 as the firing trigger 8034 is depressed towards pistol
grip 8036, stretching
a proximally placed firing trigger tension spring 8206 (FIG. 181) proximally
connected between
the upper portion 8204 of the firing trigger 8034 and the housing 8154. The
upper portion 8204
of the firing trigger 8034 engages the linked rack 8200 during each firing
trigger depression via a
spring biased side pawl mechanism 8210. When the firing trigger is released,
the side pawl
mechanism is disengaged from the linked rack 8200 and the firing trigger can
be returned to an
undepressed, or unfired, position. In use, a ramped right-side track formed by
a proximally and
rightwardly facing beveled surface 8284 in each of the links 8196a-8196d is
engaged by a side
pawl assembly 8285. In particular, a pawl slide 8270 (FIGS. 181 and 183) has
right and left
lower guides 8272 that slide respectively in a left track 8274 (FIG. 181)
formed in the closure
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yoke 8266 below the rack channel 8291 and a right track 8275 in a closure yoke
rail 8276 that
parallels rack channel 8291 and is attached to a rack channel cover 8277 that
closes a rightwardly
open portion of the rack channel 8291 in the closure yoke 8266 that is distal
to the travel of the
pawl slide 8270. In FIGS. 181, 182, and 185, a compression spring 8278 is
attached between a
hook 8279 on a top proximal position on the closure yoke rail 8276 and a hook
8280 on a distal
right-side of the pawl slide 8270, which keeps the pawl slide 8270 drawn
proximally into contact
with the upper portion 8204 of the firing trigger 8034.
[0585] With particular reference to FIG. 181, a pawl block 8318 sits on the
pawl slide 8270
pivoting about a vertical aft pin 8320 that passes through a left proximal
corner of pawl block
8318 and pawl slide 8270. A kick-out block recess 8322 is formed on a distal
portion of a top
surface of the block 8318 to receive a kick-out block 8324 pivotally pinned
therein by a vertical
pin 8326 whose bottom tip extends into a pawl spring recess 8328 on a top
surface of the pawl
slide 8270. A pawl spring 8330 in the pawl spring recess 8328 extends to the
right of the vertical
front pin 8326 urging the pawl block 8318 to rotate counterclockwise when
viewed from above
into engagement with the ramped right-side track 8282. A small coil spring
8332 in the kick-out
block recess 8322 urges the kick-out block 8324 to rotate clockwise when
viewed from above, its
proximal end urged into contact with a contoured lip 8334 formed in the
closure yoke 8266
above the rack channel 8291. As shown in FIG. 184, the stronger mechanical
advantage of the
pawl spring 8330 over the small coil spring 8332 means that the pawl block
8318 tends toward
engagement with the kick-out block 8324 rotated clockwise. In FIG. 185, as the
firing trigger
8034 is fully depressed and begins to be release, the kick-out block 8324
encounters a ridge 8336
in the contoured lip 8334 as the pawl slide 8270 retracts, forcing the kick-
out block 8324 to
rotate clockwise when viewed from above and thereby kicking out the pawl block
8318 from
engagement with the linked rack 8200. The shape of the kick-out block recess
8322 stops the
clockwise rotation of the kick-out block 8324 to a perpendicular orientation
to the contoured lip
8334 maintaining this disengagement during the full retraction and thereby
eliminating a
ratcheting noise.
[0586] In FIGS.
181, 183, 190, and 195, the surgical stapling and severing instrument
8010 can include a manual retraction mechanism 8500 that provides for a manual
release of the
firing mechanism, manual retraction, and in one version (FIGS. 196-202)
further performs
automatic retraction at the end of full firing travel. Referring now to FIGS.
181, 190, and 191, in
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particular, a front idler gear 8220 is engaged with a toothed upper, left
surface 8222 of the linked
rack 8200 wherein the front idler gear 8220 also engages an aft idler gear
8230 having a smaller
right-side ratchet gear 8231. Both the front idler gear 8220 and aft idler
gear 8230 are rotatably
connected to the handle housing 8154 respectively on front idler axle 8232 and
aft idler axle
8234. Each end of the aft axle 8232 extend through the respective right and
left housing half
shells 8156, 8158 and are attached to the left and right indicator gauge
wheels 8040, 8041 and,
since the aft axle 8234 is free spinning in the handle housing 8154 and has a
keyed engagement
to the aft gear 8230, the indicator gauge wheels 8040, 8041 rotate with the
aft gear 8230. The
gear relationship between the linked rack 8200, idler gear 8220 and aft gear
8230 may be
advantageously selected so that the toothed upper surface 8222 has tooth
dimensions that are
suitably strong and that the aft gear 8230 makes no more than one revolution
during the full
firing travel of the linked transmission firing mechanism 8150. In addition to
gear mechanism
8502 visually indicating the firing travel, or progress, the gear mechanism
8502 can also be used
to manual retract the knife. In various embodiments, the smaller right-side
ratchet gear 8231 of
the aft idler gear 8230 extends into a hub 8506 of the manual retraction lever
8042, specifically
aligned with a vertical longitudinally-aligned slot 8508 (FIG. 190) bisecting
the hub 8506. A
lateral through hole 8510 of the hub 8506 communicates with an upper recess
8512. A front
portion 8514 is shaped to receive a proximally directed locking pawl 8516 that
pivots about a
rightward lateral pin 8518 formed in a distal end of the upper recess 8512. An
aft portion 8520 is
shaped to receive an L-shaped spring tab 8522 that urges the locking pawl 8516
downward into
engagement with the right-side smaller ratchet gear 8231. A hold-up structure
8524 (FIGS. 186
and 193) projects from the right half shell 8156 into the upper recess 8512
holding up the locking
pawl 8516 from engaging the smaller right-side ratchet gear 8231 when the
manual retraction
lever 8042 is down (FIG. 193). A coil spring 8525 (FIG. 181) urges the manual
retraction lever
8042 down.
[0587] In use, as depicted in FIGS. 192 and 193, the combination
tension/compression spring
8184 may become disconnected with the linked rack distally positioned. In
FIGS. 194 and 195,
as the manual retraction lever 8042 is raised, the locking pawl 8516 rotates
clockwise and no
longer is held up by the hold-up structure 8524 and engages the smaller right-
side ratcheting gear
8231, rotating the aft idler gear 8230 clockwise when viewed from the left.
Thus, the forward
idler gear 8220 responds counterclockwise retracting the linked rack 8200. In
addition, a
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rightward curved ridge 8510 projects out from the hub 8506, sized to contact
and distally move
the anti-backup release lever 8248 to release the anti-backup mechanism 8250
as the manual
retraction lever 8042 is rotated.
[0588] In FIGS. 196-202, an automatic retraction mechanism 8600 for a surgical
stapling and
severing instrument 8010a can incorporate automatic retraction at the end of
full firing travel into
a front idler gear 8220a having a tooth 8602 that moves within a circular
groove 8604 in a cam
wheel 8606 until encountering a blockage 8608 after nearly a full rotation
corresponding to three
firing strokes. In such circumstances, rightward ridge 8610 is rotated upward
into contact a
bottom cam recess 8612 to distally move an anti-backup release lever 8248a.
With particular
reference to FIG. 197, the anti-backup release lever 8248a includes the distal
end 8254 that
operates as previously described. The circular pin 8293 and pin receptacle
8296 formed between
right and left half shells 8156, 8158 is received through a generally
rectangular aperture 8294a
formed in the anti-backup release lever 8248a aft of the bottom cam 8192, thus
allowing
longitudinal translation as well as downward locking motion of the distal end
8254 of the anti-
backup release lever 8248a. In the right half shell 8156, a horizontal
proximally open channel
8295a receives the rightward aft pin 8297 near the proximal end of the anti-
backup release lever
8248a.
[0589] In operation, before firing in FIGS. 198, 198A, the linked rack 8200
and the anti-
backup cam tube 8268 are in a refracted position, locking the anti-backup
mechanism 8250 as the
anti-backup compression spring 8264 proximally tips the anti-backup plate
8266. The automatic
retraction mechanism 8600 is at an initial state with the anti-backup release
lever 8248a retracted
with link 8196a in contact with the forward idler gear 8220a. The tooth 8602
is at a six o'clock
position with full travel of the circular groove 8604 progressing
counterclockwise thereof with
the rightward ridge 8610 just proximal to the tooth 8602. In FIGS. 199, 199A,
one firing stroke
has occurred moving up one distal link 8196b into contact with the forward
idler gear 8220a. The
tooth 8602 has progressed one third of a turn through the circular groove 8604
of the immobile
cam wheel 8606. In FIGS. 200, 200A, a second firing stroke has occurred moving
up one more
link 8196c into contact with the forward idler gear 8220a. The tooth 8602 has
progressed two
thirds of a turn through the circular groove 8604 of the immobile cam wheel
8606. In FIGS. 201,
201A, a third firing stroke has occurred moving up one distal link 8196d into
contact with the
forward idler gear 8220a. The tooth 8602 has progressed fully around the
circular groove 8604
158
into contact with the blockage 8608 initiating counterclockwise rotation (when
viewed from the
right) of the cam wheel 8606 bringing the rightward ridge 8608 into contact
with the anti-backup
release lever 8248a. In FIG. 202, the anti-backup release lever 8248a has
moved distally in
response thereto, locking the rightward front pin 8298 into the distally open
step structure 8299
and releasing the anti-backup mechanism 8250. Similar surgical stapling
instruments arc
disclosed in U.S. Patent No. 7,083,075, which issued on August 1, 2006.
(05901 Referring to FIG. 203, the staple applying assembly 9012 of a surgical
stapling
instrument 9010 accomplishes the functions of clamping onto tissue, driving
staples and severing
tissue by two distinct motions transferred longitudinally down the shaft 9016
relative to a shalt
frame 9070. This shaft frame 9070 is proximally attached to a handle of a
surgical stapling
instrument and is coupled thereto for rotation about a longitudinal axis. An
illustrative multi-
stroke handle for the surgical stapling and severing instrument is described
in greater detail in the
co-pending and co-owned U.S. patent application entitled SURGICAL STAPLING
INSTRUMENT INCORPORATING A MULTISTROKE FIRING POSITION INDICATOR
AND RETRACTION MECHANISM, Ser. No. 10/374,026, now U.S. Patent No. 7,100,949.
Other applications consistent with the present invention may incorporate a
single firing stroke,
such as described in co-pending and commonly owned U.S. patent application
SURGICAL
STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING
SYSTEMS, Ser. No. 10/441,632, now U.S. Patent No. 7,000,818.
10591] With particular reference to FIG. 204, the distal end of the shaft
frame 9070 is attached
to the staple channel 9018. The anvil 9022 has a proximal pivoting end 9072
that is pivotally
received within a proximal end 9074 of the staple channel 9018, just distal to
its engagement to
the shaft frame 9070. When the anvil 9022 is pivoted downwardly, the anvil
9022 moves a
tissue contacting surface 9028 and forming pockets 9026 toward an opposing
staple cartridge,
described in greater detail further below. The pivoting end 9072 of the anvil
9022 includes a
closure feature 9076 proximate but distal to its pivotal attachment with the
staple channel 9018.
Thus, a closure tube 9078, whose distal end includes a horseshoe aperture 9080
that engages this
closure feature 9076, selectively imparts an opening motion to the anvil 9022
during proximal
longitudinal motion and a closing motion to the anvil 9022 during distal
longitudinal motion of
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the closure tube 9078 sliding over the shaft frame 9070 in response to a
closure trigger, similar to
the above. The shaft frame 9070 encompasses and guides a firing motion from
the handle
through a longitudinally reciprocating, two-piece knife and firing bar 9090.
In particular, the
shaft frame 9070 includes a longitudinal firing bar slot 9092 that receives a
proximal portion of
the two-piece knife and firing bar 9090, specifically a laminate tapered
firing bar 9094. It should
be appreciated that the laminated tapered firing bar 9094 may be substituted
with a solid firing
bar and/or any other suitable materials.
[0592] An E-beam 9102 is the distal portion of the two-piece knife and firing
bar 9090, which
facilitates separate closure and firing as well as spacing of the anvil 9022
from the elongate
staple channel 9018 during firing. With particular reference to FIGS. 204 and
205, in addition to
any attachment treatment such as brazing or an adhesive, the knife and firing
bar 9090 are
formed of a female vertical attachment aperture 9104 proximally formed in the
E-beam 9102 that
receives a corresponding male attachment member 9106 distally presented by the
laminated
tapered firing bar 9094, allowing each portion to be formed of a selected
material and process
suitable for their disparate functions (e.g., strength, flexibility,
friction). The E-beam 9102 may
be advantageously formed of a material having suitable material properties for
forming a pair of
top pins 9110, a pair of middle pins 9112 and a bottom pin or foot 9114, as
well as being able to
acquire a sharp cutting edge 9116. In addition, integrally formed and
proximally projecting top
guide 9118 and middle guide 9120 bracketing each vertical end of the cutting
edge 9116 further
define a tissue staging area 9122 assisting in guiding tissue to the sharp
cutting edge 9116 prior
to being severed. The middle guide 9120 also serves to engage and fire the
staple applying
apparatus 9012 by abutting a stepped central member 9124 of a wedge sled 9126
(FIG. 206) that
effects staple formation by the staple applying assembly 9012, as described in
greater detail
below. Forming these features (e.g., top pins 9110, middle pins 9112, and
bottom foot 9114)
integrally with the E-beam 9102 facilitates manufacturing at tighter
tolerances relative to one
another as compared to being assembled from a plurality of parts, ensuring
desired operation
during firing and/or effective interaction with various lockout features of
the staple applying
assembly 9012.
[0593] In FIGS. 207 and 208, the staple applying assembly 9012 is shown open,
with the E-
beam 9102 fully retracted. During assembly, the lower foot 9114 of the E-beam
9102 is dropped
through a widened hole 9130 in the staple channel 9018 and the E-beam 9102 is
then advanced
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such that the E-beam 9102 slides distally along a lower track 9132 formed in
the staple channel
9018. In particular, the lower track 9132 includes a narrow slot 9133 that
opens up as a widened
slot 9134 on an undersurface of the staple channel 9018 to form an inverted T-
shapc in lateral
cross section, as depicted particularly in FIGS. 208 and 209, which
communicates with the
widened hole 9130. Once assembled, the components proximally coupled to the
laminate tapered
firing bar 9094 do not allow the lower foot 9114 to proximally travel again to
the widened hole
9130 to permit disengagement. Referring to FIG. 210, the laminate tapered
firing bar 9094
facilitates insertion of the staple applying assembly 9012 through a trocar.
In particular, a more
distal, downward projection 9136 raises the E-beam 9102 when fully retracted.
This is
accomplished by placement of the downward projection 9136 at a point where it
cams upwardly
on a proximal edge of the widened hole 9130 in the staple channel 9018.
Referring now to FIG.
211, the laminate tapered firing bar 9094 also enhances operation of certain
lockout features that
may be incorporated into the staple channel 9018 by including a more proximal
upward
projection 9138 that is urged downwardly by the shaft frame 9070 during an
initial portion of the
firing travel. In particular, a lateral bar 9140 is defined between a pair of
square apertures 9142
in the shaft frame 9070 (FIG. 204). A clip spring 9144 that encompasses the
lateral bar 9140
downwardly urges a portion of the laminate tapered firing bar 9094 projecting
distally out of the
longitudinal firing bar slot 9092, which ensures certain advantageous lockout
features arc
engaged when appropriate. This urging is more pronounced or confined solely to
that portion of
the firing travel when the upward projection 9138 contacts the clip spring
9144.
[0594] In FIGS. 207 and 208, the E-beam 9102 is retracted with the top pins
9110 thereof
residing within an anvil pocket 9150 near the pivoting proximal end of the
anvil 9022. A
downwardly open vertical anvil slot 9152 (FIG. 203) laterally widens in the
anvil 9022 into an
anvil internal track 9154 that captures the top pins 9110 of the E-beam 9102
as they distally
advance during firing, as depicted in FIGS. 210 and 211, affirmatively spacing
the anvil 9022
from the staple channel 9018. Thus, with the E-beam 9102 retracted, the
surgeon is able to
repeatably open and close the staple applying assembly 9012 until satisfied
with the placement
and orientation of tissue captured therein for stapling and severing, yet the
E-beam 9102 assists
in proper positioning of tissue even for a staple applying assembly 9012 of
reduced diameter and
correspondingly reduced rigidity. In FIGS. 203, 204, 206, 207, 209, and 215,
the staple applying
assembly 9012 is shown with the replaceable staple cartridge 9020 that
includes the wedge sled
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9126. Longitudinally aligned and parallel plurality of downwardly open wedge
slots 9202 (FIG.
209) receive respective wedges 9204 integral to the wedge sled 9126. In FIGS.
209-211, the
wedge sled 9126 thus cams upwardly a plurality of staple drivers 9206 that are
vertically slidable
within staple driver recesses 9208. In this illustrative version, each staple
driver 9206 includes
two vertical prongs, each translating upwardly into a respective staple hole
9210, or cavity 9024,
to upwardly force out and deform a staple 9023 resting thereupon against a
staple forming
surface 9214 (FIG. 211) of the anvil 9022. A central firing recess 9216 (FIG.
204) defined within
the staple cartridge 9020 proximate to the staple channel 9018 allows the
passage of the bottom,
horizontal portion 9218 (FIG. 206) of the wedge sled 9126 as well as the
middle pins 9112 of the
E-beam 9102. Specifically, a staple cartridge tray 9220 (FIGS. 204, 209)
attaches to and
underlies a polymer staple cartridge body 9222 that has the staple driver
recesses 9208, staple
holes 9210, and central firing recess 9216 formed therein. As staples 9023 are
thus formed to
either side, the sharp cutting edge 9116 enters a vertical through slot 9230
passing through the
longitudinal axis of the staple cartridge 9020, excepting only a most distal
end thereof.
[0595] Firing the staple applying assembly 9012 begins as depicted in FIG. 211
with the two-
piece knife and firing bar 9090 proximally drawn until the downward projection
9136 cams the
middle guide 9120 on the E-beam 9102 upward and aft, allowing a new staple
cartridge 9020 to
be inserted into the staple channel 9018 when the anvil 9022 is open as
depicted in FIGS. 203
and 207. In FIG. 212, the two-piece knife and firing bar 9090 has been
distally advanced a small
distance, allowing the downward projection 9136 to drop into the widened hole
9130 of the
lower track 9132 under the urging of the clip spring 9144 against the upward
projection 9138 of
the laminate tapered firing bar 9094. The middle guide 9120 prevents further
downward rotation
by resting upon the stepped central member 9124 of the wedge sled 9126, thus
maintaining the
middle pin 9112 of the E-beam within the central firing recess 9216. In FIG.
213, the two-piece
knife and fining bar 9090 has been distally fired, advancing the wedge sled
9126 to cause
formation of staples 9023 while severing tissue 9242 clamped between the anvil
9022 and staple
cartridge 9020 with the sharp cutting edge 9116. Thereafter, in FIG. 214, the
two-piece knife and
firing bar 9090 is retracted, leaving the wedge sled 9126 distally positioned.
In FIG. 215, the
middle pin 9112 is allowed to translate down into a lockout recess 9240 formed
in the staple
channel 9018 (also see FIGS. 208, 211). Thus, the operator would receive a
tactile indication as
the middle pin 9112 encounters the distal edge of the lockout recess 9240 when
the wedge sled
162
9126 (not shown in FIG. 215) is not proximally positioned (i.e., missing
staple cartridge 9020 or
spent staple cartridge 9020). Similar surgical stapling instruments are
disclosed in U.S. Patent
No. 7,380,696, which issued on June 3, 2008.
[0596] In various embodiments, as described above, a staple cartridge can
comprise a cartridge
body including a plurality of staple cavities defined therein. The cartridge
body can comprise a
deck and a top deck surface wherein each staple cavity can define an opening
in the deck surface.
As also described above, a staple can be positioned within each staple cavity
such that the staples
are stored within the cartridge body until they are ejected therefrom. Prior
to being ejected from
the cartridge body, in various embodiments, the staples can be contained with
the cartridge body
such that the staples do not protrude above the deck surface. As the staples
are positioned below
the deck surface, in such embodiments, the possibility of the staples becoming
damaged and/or
prematurely contacting the targeted tissue can be reduced. In various
circumstances, the staples
can be moved between an unfired position in which they do not protrude from
the cartridge body
and a fired position in which they have emerged from the cartridge body and
can contact an anvil
positioned opposite the staple cartridge. In various embodiments, the anvil,
and/or the forming
pockets defined within the anvil, can be positioned a predetermined distance
above the deck
surface such that, as the staples are being deployed from the cartridge body,
the staples are
deformed to a predetermined formed height. In some circumstances, the
thickness of the tissue
captured between the anvil and the staple cartridge may vary and, as a result,
thicker tissue may
be captured within certain staples while thinner tissue may be captured within
certain other
staples. In either event, the clamping pressure, or force, applied to the
tissue by the staples may
vary from staple to staple or vary between a staple on one end of a staple row
and a staple on the
other end of the staple row, for example. In certain circumstances, the gap
between the anvil and
the staple cartridge deck can be controlled such that the staples apply a
certain minimum
clamping pressure within each staple. In some such circumstances, however,
significant
variation of the clamping pressure within different staples may still exist.
[0597] In various embodiments described herein, a staple cartridge can
comprise means for
compensating for the thickness of the tissue captured within the staples
deployed from the staple
cartridge. In various embodiments, referring to FIG. 216, a staple cartridge,
such as staple
cartridge 10000, for example, can include a rigid first portion, such as
support portion 10010, for
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example, and a compressible second portion, such as tissue thickness
compensator 10020, for
example. In at least one embodiment, referring primarily to FIG. 218, the
support portion 10010
can comprise a cartridge body, a top deck surface 10011, and a plurality of
staple cavities 10012
wherein, similar to the above, each staple cavity 10012 can define an opening
in the deck surface
10011. A staple 10030, for example, can be removably positioned in each staple
cavity 10012.
In at least one such embodiment, referring primarily to FIG. 245 and as
described in greater
detail below, each staple 10030 can comprise a base 10031 and one or more legs
10032
extending from the base 10031. Prior to the staples 10030 being deployed, as
also described in
greater detail below, the bases 10031 of the staples 10030 can be supported by
staple drivers
positioned within the support portion 10010 and, concurrently, the legs 10032
of the staples
10030 can be at least partially contained within the staple cavities 10012. In
various
embodiments, the staples 10030 can be deployed between an unfired position and
a fired position
such that the legs 10032 move through the tissue thickness compensator 10020,
penetrate
through a top surface of the tissue thickness compensator 10020, penetrate the
tissue T, and
contact an anvil positioned opposite the staple cartridge 10000. As the legs
10032 are deformed
against the anvil, the legs 10032 of each staple 10030 can capture a portion
of the tissue
thickness compensator 10020 and a portion of the tissue T within each staple
10030 and apply a
compressive force to the tissue. Further to the above, the legs 10032 of each
staple 10030 can be
deformed downwardly toward the base 10031 of the staple to form a staple
entrapment area
10039 in which the tissue T and the tissue thickness compensator 10020 can be
captured. In
various circumstances, the staple entrapment area 10039 can be defined between
the inner
surfaces of the deformed legs 10032 and the inner surface of the base 10031.
The size of the
entrapment area for a staple can depend on several factors such as the length
of the legs, the
diameter of the legs, the width of the base, and/or the extent in which the
legs are deformed, for
example.
[0598] In previous embodiments, a surgeon was often required to select the
appropriate staples
having the appropriate staple height for the tissue being stapled. For
example, a surgeon could
select tall staples for use with thick tissue and short staples for use with
thin tissue. In some
circumstances, however, the tissue being stapled did not have a consistent
thickness and, thus,
some staples were unable to achieve the desired fired configuration. For
example, FIG. 250
illustrates a tall staple used in thin tissue. Referring now to FIG. 251, when
a tissue thickness
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compensator, such as tissue thickness compensator 10020, for example, is used
with thin tissue,
for example, the larger staple may be formed to a desired fired configuration.
[0599] Owing to the compressibility of the tissue thickness compensator, the
tissue thickness
compensator can compensate for the thickness of the tissue captured within
each staple. More
particularly, referring now to FIGS. 245 and 246, a tissue thickness
compensator, such as tissue
thickness compensator 10020, for example, can consume larger and/or smaller
portions of the
staple entrapment area 10039 of each staple 10030 depending on the thickness
and/or type of
tissue contained within the staple entrapment area 10039. For example, if
thinner tissue T is
captured within a staple 10030, the tissue thickness compensator 10020 can
consume a larger
portion of the staple entrapment area 10039 as compared to circumstances where
thicker tissue T
is captured within the staple 10030. Correspondingly, if thicker tissue T is
captured within a
staple 10030, the tissue thickness compensator 10020 can consume a smaller
portion of the
staple entrapment area 10039 as compared to the circumstances where thinner
tissue T is
captured within the staple 10030. In this way, the tissue thickness
compensator can compensate
for thinner tissue and/or thicker tissue and assure that a compressive
pressure is applied to the
tissue irrespective, or at least substantially irrespective, of the tissue
thickness captured within
the staples. In addition to the above, the tissue thickness compensator 10020
can compensate for
different types, or compressibilities, of tissues captured within different
staples 10030. Referring
now to FIG. 246, the tissue thickness compensator 10020 can apply a
compressive force to
vascular tissue T which can include vessels V and, as a result, restrict the
flow of blood through
the less compressible vessels V while still applying a desired compressive
pressure to the
surrounding tissue T. In various circumstances, further to the above, the
tissue thickness
compensator 10020 can also compensate for malformed staples. Referring to FIG.
247, the
malformation of various staples 10030 can result in larger staple entrapment
areas 10039 being
defined within such staples. Owing to the resiliency of the tissue thickness
compensator 10020,
referring now to FIG. 248, the tissue thickness compensator 10020 positioned
within malformed
staples 10030 may still apply a sufficient compressive pressure to the tissue
T eventhough the
staple entrapment areas 10039 defined within such malformed staples 10030 may
be enlarged.
In various circumstances, the tissue thickness compensator 10020 located
intermediate adjacent
staples 10030 can be biased against the tissue T by properly-formed staples
10030 surrounding a
malformed staple 10030 and, as a result, apply a compressive pressure to the
tissue surrounding
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and/or captured within the malformed staple 10030, for example. In various
circumstances, a
tissue thickness compensator can compensate for different tissue densities
which can arise due to
calcifications, fibrous areas, and/or tissue that has been previously stapled
or treated, for
example.
[0600] In various embodiments, a fixed, or unchangeable, tissue gap can be
defined between
the support portion and the anvil and, as a result, the staples may be
deformed to a predetermined
height regardless of the thickness of the tissue captured within the staples.
When a tissue
thickness compensator is used with these embodiments, the tissue thickness
compensator can
adapt to the tissue captured between the anvil and the support portion staple
cartridge and, owing
to the resiliency of the tissue thickness compensator, the tissue thickness
compensator can apply
an additional compressive pressure to the tissue. Referring now to FIGS. 252-
257, a staple
10030 has been formed to a predefined height H. With regard to FIG. 252, a
tissue thickness
compensator has not been utilized and the tissue T consumes the entirety of
the staple
entrapment area 10039. With regard to FIG. 259, a portion of a tissue
thickness compensator
10020 has been captured within the staple 10030, compressed the tissue T, and
consumed at least
a portion of the staple entrapment area 10039. Referring now to FIG. 254, thin
tissue T has been
captured within the staple 10030. In this embodiment, the compressed tissue T
has a height of
approximately 2/9H and the compressed tissue thickness compensator 10020 has a
height of
approximately 7/9H, for example. Referring now to FIG. 255, tissue T having an
intermediate
thickness has been captured within the staple 10030. In this embodiment, the
compressed tissue
T has a height of approximately 4/9H and the compressed tissue thickness
compensator 10020
has a height of approximately 5/9H, for example. Referring now to FIG. 256,
tissue T having an
intermediate thickness has been captured within the staple 10030. In this
embodiment, the
compressed tissue T has a height of approximately 2/3H and the compressed
tissue thickness
compensator 10020 has a height of approximately 1/3H, for example. Referring
now to FIG.
255, thick tissue T has been captured within the staple 10030. In this
embodiment, the
compressed tissue T has a height of approximately 8/9H and the compressed
tissue thickness
compensator 10020 has a height of approximately 1/9H, for example. In various
circumstances,
the tissue thickness compensator can comprise a compressed height which
comprises
approximately 10% of the staple entrapment height, approximately 20% of the
staple entrapment
height, approximately 30% of the staple entrapment height, approximately 40%
of the staple
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entrapment height, approximately 50% of the staple entrapment height,
approximately 60% of
the staple entrapment height, approximately 70% of the staple entrapment
height, approximately
80% of the staple entrapment height, and/or approximately 90% of the staple
entrapment height,
for example.
[0601] In various embodiments, the staples 10030 can comprise any suitable
unformed height.
In certain embodiments, the staples 10030 can comprise an unformed height
between
approximately 2 mm and approximately 4.8 mm, for example. The staples 10030
can comprise
an unformed height of approximately 2.0 mm, approximately 2.5 mm,
approximately 3.0 mm,
approximately 3.4 mm, approximately 3.5 mm, approximately 3.8 mm,
approximately 4.0 mm,
approximately 4.1 mm, and/or approximately 4.8 mm, for example. In various
embodiments, the
height H to which the staples can be deformed can be dictated by the distance
between the deck
surface 10011 of the support portion 10010 and the opposing anvil. In at least
one embodiment,
the distance between the deck surface 10011 and the tissue-contacting surface
of the anvil can be
approximately 0.097", for example. The height H can also be dictated by the
depth of the
forming pockets defined within the anvil. In at least one embodiment, the
forming pockets can
have a depth measured from the tissue-contacting surface, for example. In
various embodiments,
as described in greater detail below, the staple cartridge 10000 can further
comprise staple
drivers which can lift the staples 10030 toward the anvil and, in at least one
embodiment, lift, or
"overdrive", the staples above the deck surface 10011. In such embodiments,
the height H to
which the staples 10030 are formed can also be dictated by the distance in
which the staples
10030 are overdriven. In at least one such embodiment, the staples 10030 can
be overdriven by
approximately .028", for example, and can result in the staples 10030 being
formed to a height of
approximately 0.189", for example. In various embodiments, the staples 10030
can be formed to
a height of approximately 0.8 mm, approximately 1.0 mm, approximately 1.5 mm,
approximately 1.8 mm, approximately 2.0 mm, and/or approximately 2.25 mm, for
example. In
certain embodiments, the staples can be formed to a height between
approximately 2.25 mm and
approximately 3.0 mm, for example. Further to the above, the height of the
staple entrapment
area of a staple can be determined by the formed height of the staple and the
width, or diameter,
of the wire comprising the staple. In various embodiments, the height of the
staple entrapment
area 10039 of a staple 10030 can comprise the formed height H of the staple
less two diameter
widths of the wire. In certain embodiments, the staple wire can comprise a
diameter of
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approximately 0.0089", for example. In various embodiments, the staple wire
can comprise a
diameter between approximately 0.0069" and approximately 0.0119", for example.
In at least
one exemplary embodiment, the formed height H of a staple 10030 can be
approximately 0.189"
and the staple wire diameter can be approximately 0.0089" resulting in a
staple entrapment
height of approximately 0.171", for example.
[0602] In various embodiments, further to the above, the tissue thickness
compensator can
comprise an uncompressed, or pre-deployed, height and can be configured to
deform to one of a
plurality of compressed heights. In certain embodiments, the tissue thickness
compensator can
comprise an uncompressed height of approximately 0.125", for example. In
various
embodiments, the tissue thickness compensator can comprise an uncompressed
height of greater
than or equal to approximately 0.080", for example. In at least one
embodiment, the tissue
thickness compensator can comprise an uncompressed, or pre-deployed, height
which is greater
than the unfired height of the staples. In at least one embodiment, the
uncompressed, or pre-
deployed, height of the tissue thickness compensator can be approximately 10%
taller,
approximately 20% taller, approximately 30% taller, approximately 40% taller,
approximately
50% taller, approximately 60% taller, approximately 70% taller, approximately
80% taller,
approximately 90% taller, and/or approximately 100% taller than the unfired
height of the
staples, for example. In at least one embodiment, the uncompressed, or pre-
deployed, height of
the tissue thickness compensator can be up to approximately 100% taller than
the unfired height
of the staples, for example. In certain embodiments, the uncompressed, or pre-
deployed, height
of the tissue thickness compensator can be over 100% taller than the unfired
height of the
staples, for example. In at least one embodiment, the tissue thickness
compensator can comprise
an uncompressed height which is equal to the unfired height of the staples. In
at least one
embodiment, the tissue thickness compensator can comprise an uncompressed
height which is
less than the unfired height of the staples. In at least one embodiment, the
uncompressed, or pre-
deployed, height of the thickness compensator can be approximately 10%
shorter, approximately
20% shorter, approximately 30% shorter, approximately 40% shorter,
approximately 50%
shorter, approximately 60% shorter, approximately 70% shorter, approximately
80% shorter,
and/or approximately 90% shorter than the unfired height of the staples, for
example. In various
embodiments, the compressible second portion can comprise an uncompressed
height which is
taller than an uncompressed height of the tissue T being stapled. In certain
embodiments, the
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tissue thickness compensator can comprise an uncompressed height which is
equal to an
uncompressed height of the tissue T being stapled. In various embodiments, the
tissue thickness
compensator can comprise an uncompressed height which is shorter than an
uncompressed
height of the tissue T being stapled.
[0603] As described above, a tissue thickness compensator can be compressed
within a
plurality of formed staples regardless of whether thick tissue or thin tissue
is captured within the
staples. In at least one exemplary embodiment, the staples within a staple
line, or row, can be
deformed such that the staple entrapment area of each staple comprises a
height of approximately
2.0 mm, for example, wherein the tissue T and the tissue thickness compensator
can be
compressed within this height. In certain circumstances, the tissue T can
comprise a compressed
height of approximately 1.75 mm within the staple entrapment area while the
tissue thickness
compensator can comprise a compressed height of approximately 0.25 mm within
the staple
entrapment area, thereby totaling the approximately 2.0 mm staple entrapment
area height, for
example. In certain circumstances, the tissue T can comprise a compressed
height of
approximately 1.50 mm within the staple entrapment area while the tissue
thickness compensator
can comprise a compressed height of approximately 0.50 mm within the staple
entrapment area,
thereby totaling the approximately 2.0 mm staple entrapment area height, for
example. In certain
circumstances, the tissue T can comprise a compressed height of approximately
1.25 mm within
the staple entrapment area while the tissue thickness compensator can comprise
a compressed
height of approximately 0.75 mm within the staple entrapment area, thereby
totaling the
approximately 2.0 mm staple entrapment area height, for example. In certain
circumstances, the
tissue T can comprise a compressed height of approximately 1.0 mm within the
staple
entrapment area while the tissue thickness compensator can comprise a
compressed height of
approximately 1.0 mm within the staple entrapment area, thereby totaling the
approximately 2.0
mm staple entrapment area height, for example. In certain circumstances, the
tissue T can
comprise a compressed height of approximately 0.75 mm within the staple
entrapment area while
the tissue thickness compensator can comprise a compressed height of
approximately 1.25 mm
within the staple entrapment area, thereby totaling the approximately 2.0 mm
staple entrapment
area height, for example. In certain circumstances, the tissue T can comprise
a compressed
height of approximately 1.50 mm within the staple entrapment area while the
tissue thickness
compensator can comprise a compressed height of approximately 0.50 mm within
the staple
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entrapment area, thereby totaling the approximately 2.0 mm staple entrapment
area height, for
example. In certain circumstances, the tissue T can comprise a compressed
height of
approximately 0.25 mm within the staple entrapment area while the tissue
thickness compensator
can comprise a compressed height of approximately 1.75 mm within the staple
entrapment area,
thereby totaling the approximately 2.0 mm staple entrapment area height, for
example.
[0604] In various embodiments, further to the above, the tissue thickness
compensator can
comprise an uncompressed height which is less than the fired height of the
staples. In certain
embodiments, the tissue thickness compensator can comprise an uncompressed
height which is
equal to the fired height of the staples. In certain other embodiments, the
tissue thickness
compensator can comprise an uncompressed height which is taller than the fired
height of the
staples. In at least one such embodiment, the uncompressed height of a tissue
thickness
compensator can comprise a thickness which is approximately 110% of the formed
staple height,
approximately 120% of the formed staple height, approximately 130% of the
formed staple
height, approximately 140% of the formed staple height, approximately 150% of
the formed
staple height, approximately 160% of the formed staple height, approximately
170% of the
formed staple height, approximately 180% of the formed staple height,
approximately 190% of
the formed staple height, and/or approximately 200% of the formed staple
height, for example.
In certain embodiments, the tissue thickness compensator can comprise an
uncompressed height
which is more than twice the fired height of the staples. In various
embodiments, the tissue
thickness compensator can comprise a compressed height which is from
approximately 85% to
approximately 150% of the formed staple height, for example. In various
embodiments, as
described above, the tissue thickness compensator can be compressed between an
uncompressed
thickness and a compressed thickness. In certain embodiments, the compressed
thickness of a
tissue thickness compensator can be approximately 10% of its uncompressed
thickness,
approximately 20% of its uncompressed thickness, approximately 30% of its
uncompressed
thickness, approximately 40% of its uncompressed thickness, approximately 50%
of its
uncompressed thickness, approximately 60% of its uncompressed thickness,
approximately 70%
of its uncompressed thickness, approximately 80% of its uncompressed
thickness, and/ or
approximately 90% of its uncompressed thickness, for example. In various
embodiments, the
uncompressed thickness of the tissue thickness compensator can be
approximately two times,
approximately ten times, approximately fifty times, and/or approximately one
hundred times
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thicker than its compressed thickness, for example. In at least one
embodiment, the compressed
thickness of the tissue thickness compensator can be between approximately 60%
and
approximately 99% of its uncompressed thickness. In at least one embodiment,
the
uncompressed thickness of the tissue thickness compensator can be at least 50%
thicker than its
compressed thickness. In at least one embodiment, the uncompressed thickness
of the tissue
thickness compensator can be up to one hundred times thicker than its
compressed thickness. In
various embodiments, the compressible second portion can be elastic, or at
least partially elastic,
and can bias the tissue T against the deformed legs of the staples. In at
least one such
embodiment, the compressible second portion can resiliently expand between the
tissue T and
the base of the staple in order to push the tissue T against the legs of the
staple. In certain
embodiments, discussed in further detail below, the tissue thickness
compensator can be
positioned intermediate the tissue T and the deformed staple legs. In various
circumstances, as a
result of the above, the tissue thickness compensator can be configured to
consume any gaps
within the staple entrapment area.
[0605] In various embodiments, the tissue thickness compensator may comprise a
polymeric
composition. The polymeric composition may comprise one or more synthetic
polymer and/or
one or more non-synthetic polymer. The synthetic polymer may comprise a
synthetic absorbable
polymer and/or a synthetic non-absorbable polymer. In various embodiments, the
polymeric
composition may comprise a biocompatible foam, for example. The biocompatible
foam may
comprise a porous, open cell foam and/or a porous, closed cell foam, for
example. The
biocompatible foam can have a uniform pore morphology or may have a gradient
pore
morphology (i.e. small pores gradually increasing in size to large pores
across the thickness of
the foam in one direction). In various embodiments, the polymeric composition
may comprise
one or more of a porous scaffold, a porous matrix, a gel matrix, a hydrogel
matrix, a solution
matrix, a filamentous matrix, a tubular matrix, a composite matrix, a
membranous matrix, a
biostable polymer, and a biodegradable polymer, and combinations thereof. For
example, the
tissue thickness compensator may comprise a foam reinforced by a filamentous
matrix or may
comprise a foam having an additional hydrogel layer that expands in the
presence of bodily
fluids to further provide the compression on the tissue. In various
embodiments, a tissue
thickness compensator could also be comprised of a coating on a material
and/or a second or
third layer that expands in the presence of bodily fluids to further provide
the compression on the
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tissue. Such a layer could be a hydrogel that could be a synthetic and/or
naturally derived
material and could be either biodurable and/or biodegradable, for example. In
certain
embodiments, a tissue thickness compensator could be reinforced with fibrous
non-woven
materials or fibrous mesh type elements, for example, that can provide
additional flexibility,
stiffness, and/or strength. In various embodiments, a tissue thickness
compensator that has a
porous morphology which exhibits a gradient structure such as, for example,
small pores on one
surface and larger pores on the other surface. Such morphology could be more
optimal for tissue
in-growth or hemostatic behavior. Further, the gradient could be also
compositional with a
varying bio-absorption profile. A short term absorption profile may be
preferred to address
hemostasis while a long term absorption profile may address better tissue
healing without
leakages.
[06061 Examples of non-synthetic polymers include, but are not limited to,
lypholized
polysaccharide, glycoprotein, elastin, proteoglycan, gelatin, collagen, and
oxidized regenerated
cellulose (ORC). Examples of synthetic absorbable polymers include, but are
not limited to,
poly(lactic acid) (PLA), poly(L-lactic acid) (PLLA), polycaprolactone (PCL),
polyglycolic acid
(PGA), poly(trimethylene carbonate) (TMC), polyethylene terephthalate (PET),
polyhydroxyalkanoate (PHA), a copolymer of glycolide and c-caprolactone
(PGCL), a
copolymer of glycolide and-trimethylene carbonate, poly(glycerol sebacate)
(PGS),
polydioxanone, poly(orthoesters), polyanhydrides, polysaccharides, poly(ester-
amides), tyrosine-
based polyarylates, tyrosine-based polyiminocarbonates, tyrosine-based
polycarbonates,
poly(D,L-lactide-urethane), poly(B-hydroxybutyrate), poly(E-caprolactone),
polyethyleneglycol
(PEG), poly[bis(carboxylatophenoxy) phosphazene], poly(amino acids), pseudo-
poly(amino
acids), absorbable polyurethanes, and combinations thereof. In various
embodiments, the
polymeric composition may comprise from approximately 50% to approximately 90%
by weight
of the polymeric composition of PLLA and approximately 50% to approximately
10% by weight
of the polymeric composition of PCL, for example. In at least one embodiment,
the polymeric
composition may comprise approximately 70% by weight of PLLA and approximately
30% by
weight of PCL, for example. In various embodiments, the polymeric composition
may comprise
from approximately 55% to approximately 85% by weight of the polymeric
composition of PGA
and 15% to 45% by weight of the polymeric composition of PCL, for example. In
at least one
embodiment, the polymeric composition may comprise approximately 65% by weight
of PGA
172
and approximately 35% by weight of PCIõ for example. In various embodiments,
the polymeric
composition may comprise from approximately 90% to approximately 95% by weight
of the
polymeric composition of PGA and approximately 5% to approximately 10% by
weight of the
polymeric composition of PLA, for example.
[0607] In various embodiments, the synthetic absorbable polymer may comprise a
bioabsorbable, biocompatible elastomeric copolymer. Suitable bioabsorbable,
biocompatible
elastomeric copolymers include but are not limited to copolymers of epsilon-
caprolactonc and
glycolide (preferably having a mole ratio of epsilon-caprolactone to glycolide
of from about
30:70 to about 70:30, preferably 35:65 to about 65:35, and more preferably
45:55 to 35:65);
elastomeric copolymers of epsilon-caprolactone and lactide, including L-
lactide, 1)-lactide
blends thereof or lactic acid copolymers (preferably having a mole ratio of
epsilon-caprolactone
to lactide of from about 35:65 to about 65:35 and more preferably 45:55 to
30:70) elastomeric
copolymers of p-dioxanone (1,4-dioxan-2-one) and lactide including L-lactide,
D-lactide and
lactic acid (preferably having a mole ratio of p-dioxanone to lactide of from
about 40:60 to about
60:40); clastomeric copolymers of epsilon-caprolactone and p-dioxanone
(preferably having a
mole ratio of epsilon-caprolactone to p-dioxanone of from about 30:70 to about
70:30);
elastomeric copolymers of p-dioxanone and trimethylene carbonate (preferably
having a mole
ratio of p-dioxanone to trimethylene carbonate of from about 30:70 to about
70:30); elastomeric
copolymers of trimethylene carbonate and glycolide (preferably having a mole
ratio of
trimethylene carbonate to glycolide of from about 30:70 to about 70:30);
elastomeric copolymer
of trimethylene carbonate and lactide including L-lactide, D-lactide, blends
thereof or lactic acid
copolymers (preferably having a mole ratio of trimethylene carbonate to
lactide of from about
30:70 to about 70:30) and blends thereof. In one embodiment, the elastomeric
copolymer is a
copolymer of glycolide and epsilon-caprolactone. In another embodiment, the
elastomeric
copolymer is a copolymer of lactide and epsilon-caprolactone.
106081 The disclosures of U.S. Patent No. 5,468,253, entitled ELASTOMERIC
MEDICAL
DEVICE, which issued on November 21, 1995, and U.S. Patent No. 6,325,810,
entitled FOAM
BUTTRESS FOR STAPLING APPARATUS, was issued on December 4, 2001.
[06091 In various embodiments, the synthetic absorbable polymer may comprise
one or more
of 90/10 poly(glycolide-L-lactide) copolymer, commercially available from
Ethicon, Inc. under
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the trade designation VICRYL (polyglactic 910), polyglycolide, commercially
available from
American Cyanamid Co. under the trade designation DEXON, polydioxanone,
commercially
available from Ethicon, Inc. under the trade designation PDS, poly(glycolide-
trimethylene
carbonate) random block copolymer, commercially available from American
Cyanamid Co.
under the trade designation MAXON, 75/25 poly(glycolide-E-caprolactone-
poliglecaprolactone
25) copolymer, commercially available from Ethicon under the trade designation
MONOCRYL,
for example.
[0610] Examples of synthetic non-absorbable polymers include, but are not
limited to, foamed
polyurethane, polypropylene (PP), polyethylene (PE), polycarbonate,
polyamides, such as nylon,
polyvinylchloride (PVC), polymethylmetacrylate (PMMA), polystyrene (PS),
polyester,
polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE),
polytrifluorochloroethylene
(PTFCE), polyvinylfluoride (PVF), fluorinated ethylene propylene (FEP),
polyacetal,
polysulfone, and combinations thereof The synthetic non-absorbable polymers
may include, but
are not limited to, foamed elastomers and porous elastomers, such as, for
example, silicone,
polyisoprene, and rubber. In various embodiments, the synthetic polymers may
comprise
expanded polytetrafluoroethylene (ePTFE), commercially available from W. L.
Gore &
Associates, Inc. under the trade designation GORE-TEX Soft Tissue Patch and co-
polyetherester
urethane foam commercially available from Polyganics under the trade
designation
NASOF'ORE.
[0611] The polymeric composition of a tissue thickness compensator may be
characterized by
percent porosity, pore size, and/or hardness, for example. In various
embodiments, the
polymeric composition may have a percent porosity from approximately 30% by
volume to
approximately 99% by volume, for example. In certain embodiments, the
polymeric
composition may have a percent porosity from approximately 60% by volume to
approximately
98% by volume, for example. In various embodiments, the polymeric composition
may have a
percent porosity from approximately 85% by volume to approximately 97% by
volume, for
example. In at least one embodiment, the polymeric composition may comprise
approximately
70% by weight of PLLA and approximately 30% by weight of PCL, for example, and
can
comprise approximately 90% porosity by volume, for example. In at least one
such
embodiment, as a result, the polymeric composition would comprise
approximately 10%
copolymer by volume. In at least one embodiment, the polymeric composition may
comprise
174
approximately 65% by weight of PGA and approximately 35% by weight of PCL, for
example,
and can have a percent porosity from approximately 93% by volume to
approximately 95% by
volume, for example. In various embodiments, the polymeric composition may
comprise a
greater than 85% porosity by volume. The polymeric composition may have a pore
size from
approximately 5 micrometers to approximately 2000 micrometers, for example. In
various
embodiments, the polymeric composition may have a pore size between
approximately 10
micrometers to approximately 100 micrometers, for example. In at least one
such embodiment,
the polymeric composition can comprise a copolymer of PGA and PCL, for
example. In certain
embodiments, the polymeric composition may have a pore size between
approximately 100
micrometers to approximately 1000 micrometers, for example. In at least one
such embodiment,
the polymeric composition can comprise a copolymer of PLLA and PCL, for
example.
According to certain aspects, the hardness of a polymeric composition may be
expressed in terms
of the Shore Hardness, which can defined as the resistance to permanent
indentation of a material
as determined with a durometer, such as a Shore Durometer. In order to assess
the durometer
value for a given material, a pressure is applied to the material with a
durometer indenter foot in
accordance with ASTM procedure D2240-00, entitled, "Standard Test Method for
Rubber
Property-Durometer Hardness". The durometer indenter foot may be applied to
the material tbr
a sufficient period of time, such as 15 seconds, for example, wherein a
reading is then taken from
the appropriate scale. Depending on the type of scale being used, a reading of
0 can be obtained
when the indenter foot completely penetrates the material, and a reading of
100 can be obtained
when no penetration into the material occurs. This reading is dimensionless.
In various
embodiments, the durometer may be determined in accordance with any suitable
scale, such as
Type A and/or Type 00 scales, for example, in accordance with ASTM 1)2240-00.
In various
embodiments, the polymeric composition of a tissue thickness compensator may
have a Shore A
hardness value from approximately 4 A to approximately 16 A, for example,
which is
approximately 45 00 to approximately 65 00 on the Shore 00 range. In at least
one such
embodiment, the polymeric composition can comprise a PLLA/PCL copolymer or a
PGA/PC I.
copolymer, for example. In various embodiments, the polymeric composition of a
tissue
thickness compensator may have a Shore A Hardness value of less than 15 A. In
various
embodiments, the polymeric composition of a tissue thickness compensator may
have a Shore A
Hardness value of less than 10 A. In
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various embodiments, the polymeric composition of a tissue thickness
compensator may have a
Shore A Hardness value of less than 5 A. In certain embodiments, the polymeric
material may
have a Shore 00 composition value from approximately 35 00 to approximately 75
00, for
example.
[0612] In various embodiments, the polymeric composition may have at least two
of the above-
identified properties. In various embodiments, the polymeric composition may
have at least
three of the above-identified properties. The polymeric composition may have a
porosity from
85% to 97% by volume, a pore size from 5 micrometers to 2000 micrometers, and
a Shore A
hardness value from 4 A to 16 A and Shore 00 hardness value from 45 00 to 65
00, for
example. In at least one embodiment, the polymeric composition may comprise
70% by weight
of the polymeric composition of PLLA and 30% by weight of the polymeric
composition of PCL
having a porosity of 90% by volume, a pore size from 100 micrometers to 1000
micrometers,
and a Shore A hardness value from 4 A to 16 A and Shore 00 hardness value from
45 00 to 65
00, for example. In at least one embodiment, the polymeric composition may
comprise 65% by
weight of the polymeric composition of PGA and 35% by weight of the polymeric
composition
of PCL having a porosity from 93% to 95% by volume, a pore size from 10
micrometers to 100
micrometers, and a Shore A hardness value from 4 A to 16 A and Shore 00
hardness value from
45 00 to 65 00, for example.
[0613] In various embodiments, the polymeric composition may comprise a
pharmaceutically
active agent. The polymeric composition may release a therapeutically
effective amount of the
pharmaceutically active agent. In various embodiments, the pharmaceutically
active agent may
be released as the polymeric composition is desorbediabsorbed. In various
embodiments, the
pharmaceutically active agent may be released into fluid, such as, for
example, blood, passing
over or through the polymeric composition. Examples of pharmaceutically active
agents may
include, but are not limited to, hemostatic agents and drugs, such as, for
example, fibrin,
thrombin, and oxidized regenerated cellulose (ORC); anti-inflammatory drugs,
such as, for
example, diclofenac, aspirin, naproxen, sulindac, and hydrocortisone;
antibiotic and
antimicrobial drug or agents, such as, for example, triclosan, ionic silver,
ampicillin, gentamicin,
polymyxin B, chloramphenicol; and anticancer agents, such as, for example,
cisplatin,
mitomycin, adriamycin.
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[0614] In various embodiments, referring now to FIG. 216, a staple cartridge,
such as staple
cartridge 10000, for example, can comprise a support portion 10010 and a
compressible tissue
thickness compensator 10020. Referring now to FIGS. 218-220, the support
portion 10010 can
comprise a deck surface 10011 and a plurality of staple cavities 10012 defined
within the support
portion 10010. Each staple cavity 10012 can be sized and configured to
removably store a
staple, such as a staple 10030, for example, therein. The staple cartridge
10000 can further
comprise a plurality of staple drivers 10040 which can each be configured to
support one or more
staples 10030 within the staple cavities 10012 when the staples 10030 and the
staple drivers
10040 are in their unfired positions. In at least one such embodiment,
referring primarily to
FIGS. 224 and 225, each staple driver 10040 can comprise one or more cradles,
or troughs,
10041, for example, which can be configured to support the staples and limit
relative movement
between the staples 10030 and the staple drivers 10040. In various
embodiments, referring again
to FIG. 218, the staple cartridge 10000 can further comprise a staple-firing
sled 10050 which can
be moved from a proximal end 10001 to a distal end 10002 of the staple
cartridge in order to
sequentially lift the staple drivers 10040 and the staples 10030 from their
unfired positions
toward an anvil positioned opposite the staple cartridge 10000. In certain
embodiments,
referring primarily to FIGS. 218 and 220, each staple 10030 can comprise a
base 10031 and one
or more legs 10032 extending from the base 10031 wherein each staple can be at
least one of
substantially U-shaped and substantially V-shaped, for example. In at least
one embodiment, the
staples 10030 can be configured such that the tips of the staple legs 10032
are recessed with
respect to the deck surface 10011 of the support portion 10010 when the
staples 10030 are in
their unfired positions. In at least one embodiment, the staples 10030 can be
configured such
that the tips of the staple legs 10032 are flush with respect to the deck
surface 10011 of the
support portion 10010 when the staples 10030 are in their unfired positions.
In at least one
embodiment, the staples 10030 can be configured such that the tips of the
staple legs 10032, or at
least some portion of the staple legs 10032, extend above the deck surface
10011 of the support
portion 10010 when the staples 10030 are in their unfired positions. In such
embodiments, the
staple legs 10032 can extend into and can be embedded within the tissue
thickness compensator
10020 when the staples 10030 are in their unfired positions. In at least one
such embodiment,
the staple legs 10032 can extend above the deck surface 10011 by approximately
0.075", for
example. In various embodiments, the staple legs 10032 can extend above the
deck surface
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10011 by a distance between approximately 0.025" and approximately 0.125", for
example. In
certain embodiments, further to the above, the tissue thickness compensator
10020 can comprise
an uncompressed thickness between approximately 0.08" and approximately
0.125", for
example.
[0615] In use, further to the above and referring primarily to FIG. 233, an
anvil, such as anvil,
10060, for example, can be moved into a closed position opposite the staple
cartridge 10000. As
described in greater detail below, the anvil 10060 can position tissue against
the tissue thickness
compensator 10020 and, in various embodiments, compress the tissue thickness
compensator
10020 against the deck surface 10011 of the support portion 10010, for
example. Once the anvil
10060 has been suitably positioned, the staples 10030 can be deployed, as also
illustrated in FIG.
233. In various embodiments, as mentioned above, the staple-firing sled 10050
can be moved
from the proximal end 10001 of the staple cartridge 10000 toward the distal
end 10002, as
illustrated in FIG. 234. As the sled 10050 is advanced, the sled 10050 can
contact the staple
drivers 10040 and lift the staple drivers 10040 upwardly within the staple
cavities 10012. In at
least one embodiment, the sled 10050 and the staple drivers 10040 can each
comprise one or
more ramps, or inclined surfaces, which can co-operate to move the staple
drivers 10040
upwardly from their unfired positions. In at least one such embodiment,
referring to FIGS. 221-
225, each staple driver 10040 can comprise at least one inclined surface 10042
and the sled
10050 can comprise one or more inclined surfaces 10052 which can be configured
such that the
inclined surfaces 10052 can slide under the inclined surface 10042 as the sled
10050 is advanced
distally within the staple cartridge. As the staple drivers 10040 are lifted
upwardly within their
respective staple cavities 10012, the staple drivers 10040 can lift the
staples 10030 upwardly
such that the staples 10030 can emerge from their staple cavities 10012
through openings in the
staple deck 10011. During an exemplary firing sequence, referring primarily to
FIGS. 227-229,
the sled 10050 can first contact staple 10030a and begin to lift the staple
10030a upwardly. As
the sled 10050 is advanced further distally, the sled 10050 can begin to lift
staples 10030b,
10030c, 10030d, 10030e, and 10030f, and any other subsequent staples, in a
sequential order.
As illustrated in FIG. 229, the sled 10050 can drive the staples 10030
upwardly such that the legs
10032 of the staples contact the opposing anvil, are deformed to a desired
shape, and ejected
therefrom the support portion 10010. In various circumstances, the sled 10030
can move several
staples upwardly at the same time as part of a firing sequence. With regard to
the firing
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sequence illustrated in FIG. 229, the staples 10030a and 10030b have been
moved into their fully
fired positions and ejected from the support portion 10010, the staples 10030c
and 10030d are in
the process of being fired and are at least partially contained within the
support portion 10010,
and the staples 10030e and 10030f are still in their unfired positions.
[0616] As discussed above, and referring to FIG. 235, the staple legs 10032 of
the staples
10030 can extend above the deck surface 10011 of the support portion 10010
when the staples
10030 are in their unfired positions. With further regard to this firing
sequence illustrated in
FIG. 229, the staples 10030e and 10030f are illustrated in their unfired
position and their staple
legs 10032 extend above the deck surface 10011 and into the tissue thickness
compensator
10020. In various embodiments, the tips of the staple legs 10032, or any other
portion of the
staple legs 10032, may not protrude through a top tissue-contacting surface
10021 of the tissue
thickness compensator 10020 when the staples 10030 are in their unfired
positions. As the
staples 10030 are moved from their unfired positions to their fired positions,
as illustrated in
FIG. 229, the tips of the staple legs can protrude through the tissue-
contacting surface 10032. In
various embodiments, the tips of the staple legs 10032 can comprise sharp tips
which can incise
and penetrate the tissue thickness compensator 10020. In certain embodiments,
the tissue
thickness compensator 10020 can comprise a plurality of apertures which can be
configured to
receive the staple legs 10032 and allow the staple legs 10032 to slide
relative to the tissue
thickness compensator 10020. In certain embodiments, the support portion 10010
can further
comprise a plurality of guides 10013 extending from the deck surface 10011.
The guides 10013
can be positioned adjacent to the staple cavity openings in the deck surface
10011 such that the
staple legs 10032 can be at least partially supported by the guides 10013. In
certain
embodiments, a guide 10013 can be positioned at a proximal end and/or a distal
end of a staple
cavity opening. In various embodiments, a first guide 10013 can be positioned
at a first end of
each staple cavity opening and a second guide 10013 can be positioned at a
second end of each
staple cavity opening such that each first guide 10013 can support a first
staple leg 10032 of a
staple 10030 and each second guide 10013 can support a second staple leg 10032
of the staple.
In at least one embodiment, referring to FIG. 235, each guide 10013 can
comprise a groove or
slot, such as groove 10016, for example, within which a staple leg 10032 can
be slidably
received. In various embodiments, each guide 10013 can comprise a cleat,
protrusion, and/or
spike that can extend from the deck surface 10011 and can extend into the
tissue thickness
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compensator 10020. In at least one embodiment, as discussed in greater detail
below, the cleats,
protrusions, and/or spikes can reduce relative movement between the tissue
thickness
compensator 10020 and the support portion 10010. In certain embodiments, the
tips of the staple
legs 10032 may be positioned within the guides 10013 and may not extend above
the top
surfaces of the guides 10013 when the staples 10030 are in their unfired
position. In at least such
embodiment, the guides 10013 can define a guide height and the staples 10030
may not extend
above this guide height when they are in their unfired position.
[0617] In various embodiments, a tissue thickness compensator, such as tissue
thickness
compensator 10020, for example, can be comprised of a single sheet of
material. In at least one
embodiment, a tissue thickness compensator can comprise a continuous sheet of
material which
can cover the entire top deck surface 10011 of the support portion 10010 or,
alternatively, cover
less than the entire deck surface 10011. In certain embodiments, the sheet of
material can cover
the staple cavity openings in the support portion 10010 while, in other
embodiments, the sheet of
material can comprise openings which can be aligned, or at least partially
aligned, with the staple
cavity openings. In various embodiments, a tissue thickness compensator can be
comprised of
multiple layers of material. In some embodiments, referring now to FIG. 217, a
tissue thickness
compensator can comprise a compressible core and a wrap surrounding the
compressible core.
In certain embodiments, a wrap 10022 can be configured to releasably hold the
compressible
core to the support portion 10010. In at least one such embodiment, the
support portion 10010
can comprise one or more projections, such as projections 10014 (FIG. 220),
for example,
extending therefrom which can be received within one or more apertures and/or
slots, such as
apertures 10024, for example, defined in the wrap 10022. The projections 10014
and the
apertures 10024 can be configured such that the projections 10014 can retain
the wrap 10022 to
the support portion 10010. In at least one embodiment, the ends of the
projections 10014 can be
deformed, such as by a heat-stake process, for example, in order to enlarge
the ends of the
projections 10014 and, as a result, limit the relative movement between the
wrap 10022 and the
support portion 10010. In at least one embodiment, the wrap 10022 can comprise
one or more
perforations 10025 which can facilitate the release of the wrap 10022 from the
support portion
10010, as illustrated in FIG. 217. Referring now to FIG. 226, a tissue
thickness compensator can
comprise a wrap 10222 including a plurality of apertures 10223, wherein the
apertures 10223 can
be aligned, or at least partially aligned, with the staple cavity openings in
the support portion
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10010. In certain embodiments, the core of the tissue thickness compensator
can also comprise
apertures which are aligned, or at least partially aligned, with the apertures
10223 in the wrap
10222. In other embodiments, the core of the tissue thickness compensator can
comprise a
continuous body and can extend underneath the apertures 10223 such that the
continuous body
covers the staple cavity openings in the deck surface 10011.
[0618] In various embodiments, as described above, a tissue thickness
compensator can
comprise a wrap for releasably holding a compressible core to the support
portion 10010. In at
least one such embodiment, referring to FIG. 218, a staple cartridge can
further comprise retainer
clips 10026 which can be configured to inhibit the wrap, and the compressible
core, from
prematurely detaching from the support portion 10010. In various embodiments,
each retainer
clip 10026 can comprise apertures 10028 which can be configured to receive the
projections
10014 extending from the support portion 10010 such that the retainer clips
10026 can be
retained to the support portion 10010. In certain embodiments, the retainer
clips 10026 can each
comprise at least one pan portion 10027 which can extend underneath the
support portion 10010
and can support and retain the staple drivers 10040 within the support portion
10010. In certain
embodiments, as described above, a tissue thickness compensator can be
removably attached to
the support portion 10010 by the staples 10030. More particularly, as also
described above, the
legs of the staples 10030 can extend into the tissue thickness compensator
10020 when the
staples 10030 are in their unfired position and, as a result, releasably hold
the tissue thickness
compensator 10020 to the support portion 10010. In at least one embodiment,
the legs of the
staples 10030 can be in contact with the sidewalls of their respective staple
cavities 10012
wherein, owing to friction between the staple legs 10032 and the sidewalls,
the staples 10030 and
the tissue thickness compensator 10020 can be retained in position until the
staples 10030 are
deployed from the staple cartridge 10000. When the staples 10030 are deployed,
the tissue
thickness compensator 10020 can be captured within the staples 10030 and held
against the
stapled tissue T. When the anvil is thereafter moved into an open position to
release the tissue T,
the support portion 10010 can be moved away from the tissue thickness
compensator 10020
which has been fastened to the tissue. In certain embodiments, an adhesive can
be utilized to
removably hold the tissue thickness compensator 10020 to the support portion
10010. In at least
one embodiment, a two-part adhesive can be utilized wherein, in at least one
embodiment, a first
part of the adhesive can be placed on the deck surface 10011 and a second part
of the adhesive
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can be placed on the tissue thickness compensator 10020 such that, when the
tissue thickness
compensator 10020 is placed against the deck surface 10011, the first part can
contact the second
part to active the adhesive and detachably bond the tissue thickness
compensator 10020 to the
support portion 10010. In various embodiments, any other suitable means could
be used to
detachably retain the tissue thickness compensator to the support portion of a
staple cartridge.
[0619] In various embodiments, further to the above, the sled 10050 can be
advanced from the
proximal end 10001 to the distal end 10002 to fully deploy all of the staples
10030 contained
within the staple cartridge 10000. In at least one embodiment, referring now
to FIGS. 258-262,
the sled 10050 can be advanced distally within a longitudinal cavity 10016
within the support
portion 10010 by a firing member, or knife bar, 10052 of a surgical stapler.
In use, the staple
cartridge 10000 can be inserted into a staple cartridge channel in a jaw of
the surgical stapler,
such as staple cartridge channel 10070, for example, and the firing member
10052 can be
advanced into contact with the sled 10050, as illustrated in FIG. 258. As the
sled 10050 is
advanced distally by the firing member 10052, the sled 10050 can contact the
proximal-most
staple driver, or drivers, 10040 and fire, or eject, the staples 10030 from
the cartridge body
10010, as described above. As illustrated in FIG. 258, the firing member 10052
can further
comprise a cutting edge 10053 which can be advanced distally through a knife
slot in the support
portion 10010 as the staples 10030 are being fired. In various embodiments, a
corresponding
knife slot can extend through the anvil positioned opposite the staple
cartridge 10000 such that,
in at least one embodiment, the cutting edge 10053 can extend between the
anvil and the support
portion 10010 and incise the tissue and the tissue thickness compensator
positioned
therebetween. In various circumstances, the sled 10050 can be advanced
distally by the firing
member 10052 until the sled 10050 reaches the distal end 10002 of the staple
cartridge 10000, as
illustrated in FIG. 260. At such point, the firing member 10052 can be
retracted proximally. In
some embodiments, the sled 10050 can be retracted proximally with the firing
member 10052
but, in various embodiments, referring now to FIG. 261, the sled 10050 can be
left behind in the
distal end 10002 of the staple cartridge 10000 when the firing member 10052 is
retracted. Once
the firing member 10052 has been sufficiently retracted, the anvil can be re-
opened, the tissue
thickness compensator 10020 can be detached from the support portion 10010,
and the remaining
non-implanted portion of the expended staple cartridge 10000, including the
support portion
10010, can be removed from the staple cartridge channel 10070.
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[0620] After the expended staple cartridge 10000 has been removed from the
staple cartridge
channel, further to the above, a new staple cartridge 10000, or any other
suitable staple cartridge,
can be inserted into the staple cartridge channel 10070. In various
embodiments, further to the
above, the staple cartridge channel 10070, the firing member 10052, and/or the
staple cartridge
10000 can comprise co-operating features which can prevent the firing member
10052 from
being advanced distally a second, or subsequent, time without a new, or
unfired, staple cartridge
10000 positioned in the staple cartridge channel 10070. More particularly,
referring again to
FIG. 258, as the firing member 10052 is advanced into contact with the sled
10050 and, when the
sled 10050 is in its proximal unfired position, a support nose 10055 of the
firing member10052
can be positioned on and/or over a support ledge 10056 on the sled 10050 such
that the fining
member 10052 is held in a sufficient upward position to prevent a lock, or
beam, 10054
extending from the firing member 10052 from dropping into a lock recess
defined within the
staple cartridge channel. As the lock 10054 will not drop into the lock
recess, in such
circumstances, the lock 10054 may not abut a distal sidewall 10057 of the lock
recess as the
firing member 10052 is advanced. As the firing member 10052 pushes the sled
10050 distally,
the firing member 10052 can be supported in its upward firing position owing
to the support nose
10055 resting on the support ledge 10056. When the firing member 10052 is
retracted relative to
the sled 10050, as discussed above and illustrated in FIG. 261, the firing
member 10052 can drop
downwardly from its upward position as the support nose 10055 is no longer
resting on the
support ledge 10056 of the sled 10050. In at least one such embodiment, the
surgical staple can
comprise a spring 10058, and/or any other suitable biasing element, which can
be configured to
bias the firing member 10052 into its downward position. Once the firing
member 10052 has
been completely retracted, as illustrated in FIG. 262, the firing member 10052
cannot be
advanced distally through the spent staple cartridge 10000 once again. More
particularly, the
firing member 10052 can't be held in its upper position by the sled 10050 as
the sled 10050, at
this point in the operating sequence, has been left behind at the distal end
10002 of the staple
cartridge 10000. Thus, as mentioned above, in the event that the firing member
10052 is
advanced once again without replacing the staple cartridge, the lock beam
10054 will contact the
sidewall 10057 of the lock recess which will prevent the firing member 10052
from being
advanced distally into the staple cartridge 10000 once again. Stated another
way, once the spent
staple cartridge 10000 has been replaced with a new staple cartridge, the new
staple cartridge
183
will have a proximally-positioned sled 10050 which can hold the firing member
10052 in its
upper position and allow the firing member 10052 to be advanced distally once
again.
[0621] As described above, the sled 10050 can be configured to move the staple
drivers 10040
between a first, unfired position and a second, fired position in order to
eject staples 10030 from
the support portion 10010. In various embodiments, the staple drivers 10040
can be contained
within the staple cavities 10012 after the staples 10030 have been ejected
from the support
portion 10010. In certain embodiments, the support portion 10010 can comprise
one or more
retention features which can be configured to block the staple drivers 10040
from being ejected
from, or falling out of, the staple cavities 10012. In various other
embodiments, the sled 10050
can be configured to eject the staple drivers 10040 from the support portion
10010 with the
staples 10030. In at least one such embodiment, the staple drivers 10040 can
be comprised of a
bioabsorbable and/or biocompatible material, such as Ultem, for example. In
certain
embodiments, the staple drivers can be attached to the staples 10030. In at
least one such
embodiment, a staple driver can be molded over and/or around the base of each
staple 10030
such that the driver is integrally formed with the staple. U.S. Patent
Application Serial No.
11/541,123, now U.S. Patent No. 7,794,475, entitled SURGICAL STAPLES HAVING
COMPRESSIBLE OR CRUSHABLE MEMBERS FOR SECURING TISSUE THEREIN AND
STAPLING INSTRUMENTS FOR DEPLOYING THE SAME, was filed on September 29,
2006.
[0622] In various circumstances, further to the above, a compressible tissue
thickness
compensator can move, twist, and/or deflect relative to the underlying rigid
support portion of a
staple cartridge. In various embodiments, the support portion, and/or any
other suitable portion
of the staple cartridge, can comprise one or more features configured to limit
relative movement
between the tissue thickness compensator and the support portion. As described
above, at least a
portion of the staples 10030 can extend above the deck surface 10011 of the
support portion
10010 wherein, in certain circumstances, referring now to FIGS. 263 and 264,
lateral forces
applied to a tissue thickness compensator 10120, for example, can be resisted
by the staples
10030 and/or the cleats 10013 extending from the support portion 10010, for
example. In
various circumstances, the staples 10030 may tilt and/or bend within the
staple cavities 10012
while resisting the lateral movement of the tissue thickness compensator 10120
wherein, in
various embodiments, the staple cavities 10012 and the staples 10030 can be
sized and
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configured to maintain the relative alignment between the legs 10032 of the
staples 10030 and
the forming pockets 10062 in the opposing anvil 10060 such that the staples
10000 are properly
formed during the staple forming process. In various embodiments, the staples
10030 and/or the
cleats 10013 can be configured to prevent or at least limit lateral distortion
within the tissue
thickness compensator 10020, as illustrated in FIG. 264. In at least one such
embodiment, the
staples 10030 and/or cleats 10013, for example, can be configured to stiffen,
or limit the lateral
and/or longitudinal movement of, a first, or tissue-contacting, surface 10021
of the tissue
thickness compensator relative to a second, or bottom, surface 10029 In
various embodiments, a
staple cartridge, and/or a staple cartridge channel in which the staple
cartridge is positioned, can
comprise at least one distortion minimizing member which can extend upwardly
to limit the
lateral and/or longitudinal movement, or distortion, of a tissue thickness
compensator. A wrap at
least partially surrounding a tissue thickness compensator, as discussed
above, may also prevent,
or at least limit, the lateral and/or longitudinal movement, or distortion, of
the tissue thickness
compensator.
[0623] In various embodiments, referring again to FIGS. 263 and 264, a tissue
thickness
compensator, such as tissue thickness compensator 10120, for example, can
comprise a core
10128 and a skin 10122. The skin 10122 and the compressible core 10128 can be
comprised of
different materials or, alternatively, of the same material. In either event,
the skin 10122 can
have a higher density than the core 10128. In circumstances where the skin
10122 comprises the
top of the tissue thickness compensator 10120, the tips of the staple legs
10032 can be embedded
in the skin 10122. In embodiments wherein a skin comprises the bottom of the
tissue thickness
compensator 10120, the staple legs 10032 can extend through the skin and into
the core. In
either event, the skin of the tissue thickness compensator can assist in
holding the staple legs
10032 in alignment with the forming pockets 10062 of the anvil 10060. In
various
embodiments, the skin 10122 can comprise a density which is approximately 10%
greater than
the density of the core 10128, approximately 20% greater than the density of
the core 10128,
approximately 30% greater than the density of the core 10128, approximately
40% greater than
the density of the core 10128, approximately 50% greater than the density of
the core 10128,
approximately 60% greater than the density of the core 10128, approximately
70% greater than
the density of the core 10128, approximately 80% greater than the density of
the core 10128,
approximately 90% greater than the density of the core 10128, and/or
approximately 100%
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greater than the density of the core 10128, for example. In various
embodiments, the skin 10122
can comprise a density which is more than the density of the core 10128 and
less than twice the
density of the core 10128, for example. In various embodiments, the skin 10122
can comprise a
density which is over twice the density of the core 10128, for example. In
various embodiments,
further to the above, the skin 10122 and the core 10128 can be formed, or
manufactured,
simultaneously. In at least one such embodiment, a fluid comprising any
suitable material
disclosed herein can be poured into a dish or mold and, while the fluid
solidifies, the fluid can
form a skin, or layer, which has a higher density than the remainder of the
material. In various
embodiments, multiple layers within a material can be formed by utilizing a
process in which
one or more subsequent layers of material are poured onto a previously cured
layer. In certain
embodiments, two or more layers can be bonded to each other with an adhesive,
for example. In
some embodiments, two or more layers can be attached to each other by one or
more fasteners
and/or one or more mechanical interlocking features, for example. In at least
one such
embodiment, adjacent layers can be connected together by one or more dovetail
joints, for
example. In certain embodiments, the skin can comprise a sealed surface which
can prevent, or
at least limit, the flow of fluid therethrough. In certain other embodiments,
the skin can
comprise an open cell porous structure, for example.
[0624] In various embodiments, further to the above, the skin can be cut off
of the tissue
thickness compensator. In at least one embodiment, the tissue thickness
compensator can be cut
from a larger block of material such that the tissue thickness compensator
does not comprise a
skin In at least one such embodiment, the tissue thickness compensator can be
comprised of a
homogenous, or at least substantially homogeneous, material, comprising large
pores, for
example.
[0625] In various embodiments, a staple cartridge can comprise a plurality of
staple cavities
each containing a staple positioned therein wherein the staple cavities can be
arranged in a
plurality of rows, and wherein an anvil positioned opposite the staple
cartridge can comprise a
plurality of forming pockets which correspond to the staple cavities in the
staple cartridge.
Stated another way, the anvil can comprise a plurality of forming pocket rows
wherein each
forming pocket can be positioned opposite a staple cavity in the staple
cartridge. In various
embodiments, each forming pocket can comprise two forming cups configured to
receive the
staple legs 10032 of a staple 10030 wherein each forming cup is configured to
receive a staple
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leg 10032 and form or curl the staple leg 10032 toward the other staple leg
10032, for example.
In various circumstances, the legs 10032 may miss or not properly enter into
the forming cups
and, as a result, the staple legs 10032 may become malformed during the firing
sequence. In
various embodiments described herein, an anvil can comprise an array, or grid,
of forming
pockets which are each configured to receive and form a staple leg. In at
least one such
embodiment, the array of fainting pockets can comprise a quantity of forming
pockets that
exceeds the quantity of staples contained within the staple cartridge. In at
least one embodiment,
a staple cartridge can comprise six longitudinal rows of staple cavities, for
example, wherein the
anvil can comprise six rows of forming pockets aligned with the six rows of
staple cavities and,
in addition, forming pockets positioned intermediate the rows of forming
pockets. For example,
on one side of the anvil, the anvil can comprise a first row of forming
pockets which can be
positioned over a first row of staple cavities, a second row of forming
pockets which can be
positioned over a second row of staple cavities that is adjacent to the first
row of staple cavities,
and, in addition, a row of forming pockets positioned intermediate the first
row of forming
pockets and the second row of forming pockets. In various embodiments,
referring now to FIGS.
276-279, an anvil 10260 can comprise six rows of forming pockets 10261 which
can be
configured to be placed over six corresponding rows of staple cavities in the
staple cartridge
10200. In at least one such embodiment, rows of intermediate forming pockets
10262 can be
positioned intermediate and/or adjacent to the rows of forming pockets 10261.
In certain
embodiments, referring now to FIGS. 277, 278, and 280, each forming pocket
10261 and 10262
can comprise two forming cups, wherein each forming cup can comprise a distal
portion 10263
which can be configured to form or curl a staple leg 10032 proximally and a
proximal portion
10264 which can be configured to form or curl a staple leg 10032 distally. In
various other
circumstances, the staples 10030 can be formed in a variety of other ways. For
example, a staple
10030 can be formed such that one leg 10032 is formed outwardly and the other
leg 10032 is
formed inwardly (FIG. 281), or such that both legs 10032 are formed outwardly
(FIG. 282)
depending on, one, which forming cups that the staple legs 10032 enter into
and/or, two, whether
the legs 10032 enter into the proximal portion 10263 or the distal portion
10064 of each forming
cup, for example.
[0626] In various embodiments, further to the above, each forming pocket 10261
and/or
forming pocket 10262 can comprise a triangular or diamond-like shape, for
example. In at least
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one embodiment, each distal portion 10263 and/or each proximal portion 10264
of the forming
pockets can comprise a triangular shape wherein, in at least one such
embodiment, the triangular
shapes of the distal portions 10263 and the proximal portions 10264 can be
arranged such that
they have vertices pointing in opposite directions. In certain embodiments, an
anvil can
comprise an array of substantially square forming pockets, for example. In at
least one such
embodiment, the forming surface of each square forming pocket can comprise an
arcuate surface
that extends between the sides of the square. In some embodiments, an anvil
can comprise an
array of circular or spherical dimples, for example. In various embodiments,
further to the
above, the forming pockets 10261 can be positioned along one or more lines
and, similarly, the
forming pockets 10262 can also be positioned along one or more lines. In
various other
embodiments, the forming pockets 10261 and/or the forming pockets 10262 can be
arranged in
one or more circular rows. In at least one such embodiment, the forming
pockets 10261 can be
arranged along a primary circumference and the forming pockets 10262 can be
arranged along a
different circumference. In various embodiments, the primary circumference and
the different
circumference can be concentric, or at least substantially concentric. In
certain embodiments, the
forming pockets 10262 can be arranged along an inner circumference positioned
radially
inwardly with respect to the primary circumference and/or an outer
circumference positioned
radially outwardly with respect to the primary circumference, for example. In
various
embodiments, the primary circumference can be defined by a primary diameter,
the inner
circumference can be defined by an inner diameter, and the outer circumference
can be defined
by an outer diameter. In at least one such embodiment, the inner diameter can
be shorter than the
primary diameter and the outer diameter can be longer than the primary
diameter.
[0627] In various embodiments, as described above, an anvil can be moved from
an open
position to a closed position in order to compress tissue against the tissue
thickness compensator
of a staple cartridge, such as tissue thickness compensator 10020, for
example. In various
circumstances, the tissue thickness compensator can be positioned adjacent to
the support portion
of the staple cartridge prior to the tissue thickness compensator being
positioned relative to the
tissue. In certain embodiments, the tissue thickness compensator 10020 can be
in a position in
which it abuts the support portion 10018 prior to the anvil being moved into
its closed position.
In certain other embodiments, the tissue thickness compensator 10020 can be in
a position in
which a gap is present between the tissue thickness compensator 10020 and the
support portion
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10018. In at least one such embodiment, the anvil can displace the tissue and
the tissue thickness
compensator 10020 downwardly until the tissue thickness compensator 10020
abuts the support
portion 10018 wherein, at such point, the anvil can be moved into is closed
position and generate
compression within the tissue. In the event that a surgeon is not satisfied
with the positioning of
the tissue between the anvil and the staple cartridge, the surgeon can open
the anvil, adjust the
position of the anvil and the staple cartridge, and close the anvil once
again. Owing to such
positioning and re-positioning of the staple cartridge relative to the tissue,
in various
circumstances, the distal end of the tissue thickness compensator 10020 may
become dislodged
from the support portion 10010, for example. In some such circumstances, the
distal end of the
tissue thickness compensator 10020 can contact the tissue and peel away from,
or roll relative to,
the support portion 10010. In various embodiments, as described in greater
detail below, a staple
cartridge can comprise one or more features configured to releasably retain a
tissue thickness
compensator to an underlying support portion of the staple cartridge
[0628] In various embodiments, referring now to FIG. 265, a staple cartridge
10300 can
comprise a support portion 10310, a tissue thickness compensator 10320
supported by the
support portion 10310, and a distal end 10302 which includes a nose 10303
configured to
releasably hold a distal end 10325 of the tissue thickness compensator 10320
in position. In at
least one embodiment, the nose 10303 can comprise a slot 10305 configured to
receive the distal
end 10325 of the tissue thickness compensator 10320. In various embodiments,
the distal end
10325 can be compressed, or wedged, within the slot 10305 such that the distal
end 10325 can be
held in place as the staple cartridge 10300 is positioned relative to the
tissue. In at least one such
embodiment, the slot 10305 can be oriented in a direction which is parallel,
or at least
substantially parallel, to the deck surface 10311 of the support portion
10310. In various
embodiments, the slot 10305 can be horizontal with respect to the deck surface
10311. In various
other embodiments, referring now to FIG. 266, a staple cartridge 10400 can
comprise a support
portion, a tissue thickness compensator 10420 supported by support portion,
and a distal end
10402 which includes a nose 10403 configured to releasably hold the distal end
10425 of the
tissue thickness compensator 10420 in position. In at least one embodiment,
the distal end
10425 can comprise a projection extending therefrom and the nose 10403 can
comprise a vertical
slot 10405 configured to receive the projection of the distal end 10425. In
various embodiments,
the distal end 10425, and/or the projection extending therefrom, can be
compressed, or wedged,
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within the slot 10405 such that the distal end 10425 can be held in place as
the staple cartridge
10400 is positioned relative to the tissue. In certain embodiments, the tissue
thickness
compensator 10420 can comprise a slot, such as slot 10429, for example, which
can be
configured to receive at least a portion of the nose 10403 therein. In at
least one embodiment,
the slot 10405 can be oriented in a direction which is perpendicular, or at
least substantially
perpendicular, to the deck surface 10411 of the support portion. In various
embodiments,
referring now to FIG. 267, a staple cartridge 10500 can comprise a support
portion, a tissue
thickness compensator 10520 supported by the support portion, and a distal end
10502 which
includes a nose configured to releasably hold the distal end 10525 of the
tissue thickness
compensator 10520 in position. In at least one embodiment, the nose can
comprise a vertical slot
10505 configured to receive the distal end 10525 of the tissue thickness
compensator 10520. In
various embodiments, the distal end 10525 can be compressed, or wedged, within
the slot 10505
such that the distal end 10525 can be held in place as the staple cartridge
10500 is positioned
relative to the tissue.
[0629] In various embodiments, referring again to FIG. 265, the tissue
thickness compensator
10320 can comprise a top surface 10324 which can be positioned above the top
surface 10304 of
the nose 10303. Another exemplary embodiment in which the top surface of a
tissue thickness
compensator is positioned above the nose of the staple cartridge is
illustrated in FIG. 238,
wherein the top surface 10721 of the tissue thickness compensator 10720 is
positioned above the
top surface 10004 of the nose 10003, for example. In use, referring once again
to FIG. 265,
tissue can slide over the top surface 10304 of the nose 10303 and, in some
circumstance, the
tissue can contact the distal end 10325 of the tissue thickness compensator
10320 and can apply
a force to the tissue thickness compensator 10320 tending to peel the tissue
thickness
compensator 10320 away from the support portion 10310. In the embodiments
described herein,
this peel force can be resisted by the portion of the distal end 10325 wedged
within the nose
10303. In any event, once the tissue has been suitably positioned relative to
the staple cartridge
13000, an anvil can be rotated into a closed position to compress the tissue
and the tissue
thickness compensator 10320 against the support portion 10310. In at least one
such
embodiment, the anvil can be rotated into a position in which the anvil
contacts the top surface
10304 of the nose 10303 and, as a result, the anvil can be prevented from
rotating further. In
various circumstances, owing to the top surface 10324 of the tissue thickness
compensator 10320
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being positioned above the top surface 10304 of the nose 10303, the top
surface 10324 can be
pushed downwardly toward the support portion 10310 as the anvil is being
closed and, in some
circumstances, the top surface 10324 can be pushed below the top surface 10304
of the nose
10303, for example. After the staples contained within the staple cartridge
10300 have been
deployed and the tissue thickness compensator 10320 has been incised, as
described herein, the
support portion 10310 and the nose 10303 can be moved away from the tissue
thickness
compensator 10320 such that the distal end 10325 of the tissue thickness
compensator 10320 can
slide out of the slot 10305.
[0630] As described above, an anvil, such as anvil 10060, for example, can be
rotated into a
closed position in which the anvil 10060 contacts the top nose surface 10004
of a staple
cartridge, such as staple cartridge 10000, for example. Once the anvil has
reached its closed
position, the amount in which a tissue thickness compensator, such as tissue
thickness
compensator 10020, for example, is compressed will depend on, among other
things, the
uncompressed thickness, or height, of the tissue thickness compensator and the
thickness of the
tissue. Referring now to FIGS. 236 and 237, a tissue thickness compensator
10920 can comprise
a top surface which is flush, or at least substantially flush, with the top
surface 10004 of the nose
10003. In such embodiments, the top surface of the tissue thickness
compensator 10920 can be
pushed below the top surface 10004 of the nose 10003. Referring now to FIGS.
241 and 242, a
tissue thickness compensator, such as tissue thickness compensator 10820, for
example, can
comprise a top surface 10821 which is positioned below the top nose surface
10004 prior to the
tissue thickness compensator 10820 being compressed by the tissue T and anvil
10060. In the
circumstances where the tissue T is relatively thin, as illustrated in FIGS.
239 and 240, the tissue
thickness compensator 10920 may undergo relatively little compression.
Referring now to FIGS.
241 and 242, the tissue thickness compensator 10820 may undergo a larger
compression when
the tissue T is relatively thicker. In the circumstances where the tissue T
has both thin sections
and thicker sections, as illustrated in FIGS. 243 and 244, the tissue
thickness compensator 10820
may be compressed a larger amount when it is positioned under the thicker
tissue T and a lesser
amount when it is positioned under the thinner tissue T, for example. In this
way, as described
above, the tissue thickness compensator can compensate for different tissue
thicknesses.
[0631] In various embodiments, referring now to FIGS. 268-270, a surgical
stapling instrument
can comprise, one, a cartridge channel 16670 configured to receive a staple
cartridge 16600 and,
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two, an anvil 16660 pivotably coupled to the cartridge channel 16670. The
staple cartridge
16600 can comprise a support portion 16610 and a tissue thickness compensator
16620 wherein
a distal end 16625 of the tissue thickness compensator 16620 can be releasably
held to the
support portion 16610 by a nose 16603 at the distal end 16602 of the staple
cartridge 16600. In
at least one embodiment, the nose 16603 can comprise a slot 16605 and can be
comprised of a
flexible material. In use, referring primarily to FIG. 269, the nose 16603 can
be flexed
downwardly in order to expand the opening of slot 16605. In certain
embodiments, the nose
16603 can comprise notches or cut-outs 16606 which can be configured to permit
the nose 16603
to flex downwardly. In any event, in various circumstances, the expanded
opening of the slot
16605 can facilitate the insertion of the distal end 16625 of the tissue
thickness compensator
16620 into the slot 16605. Once the tissue thickness compensator 16620 has
been suitably
positioned, the nose 16603 can be released and, owing to the resiliency of the
material
comprising the nose 16603, the nose 16603 can return, or at least
substantially return, to its
unflexed condition and trap the distal end 16625 of the tissue thickness
compensator 16620
against the deck surface 16611, as illustrated in FIG. 270. In use, similar to
the above, the distal
end 16625 can be pulled out of the slot 16605 when the support portion 16610
is moved away
from the stapled tissue. In various circumstances, the flexible nose 16603 can
be configured to
deflect as the tissue thickness compensator 16620 is detached from the support
portion 16610. In
various embodiments, referring again to FIG. 270, the tissue thickness
compensator 16620 can
comprise a top surface 16621 which is aligned, or at least substantially
aligned, with a top
surface 16604 of the nose 16603.
[0632] In various embodiments, referring to FIG. 271, a surgical stapling
instrument can
comprise, one, a channel 10770 configured to receive a staple cartridge 10700
and, two, an anvil
10760 rotatably coupled to the channel 10770. The staple cartridge 10700 can
comprise a
support portion 10710 and a tissue thickness compensator 10720. In various
embodiments, the
tissue thickness compensator 10720 can be held in position by a nose sock
10703 which can be
slid over the support portion 10710. In at least one embodiment, referring
primarily to FIG. 272,
the nose sock 10703 can comprise one or more side slots 10707 which can be
configured to
removably receive one or more attachment rails extending along the support
portion 10710, for
example. In various embodiments, the tissue thickness compensator 10720 can be
positioned
intermediate the side slots 10707. In certain embodiments, the nose sock 10703
can further
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comprise a distal end 10702 and a cavity 10706 defined in the distal end 10702
wherein the
cavity 10706 can also be configured to receive at least a portion of the
support portion 10710, for
example, therein. In use, the nose sock 10703 can be slid onto the support
portion 10710 in a
distal to proximal direction. In various embodiments, the tissue thickness
compensator 10720
can be removably mounted to the nose sock 10703 such that, after staples have
been fired
through the tissue thickness compensator 10720, the tissue thickness
compensator 10720 can
detach from the nose sock 10703 as the support portion 10710 and the nose sock
10703 are
moved away from the tissue thickness compensator 10720. In various
embodiments, the top
surface 10721 of the tissue thickness compensator 10720 can be positioned
below the top surface
10704 of the nose 10703.
[0633] In various embodiments, referring now to FIGS. 273 and 274, a surgical
stapling
instrument can comprise, one, a staple cartridge channel 11070 configured to
receive a staple
cartridge 11000 and, two, an anvil 11060 rotatably coupled to the channel
11070. The staple
cartridge 11000 can comprise a support portion 11010 and a tissue thickness
compensator 11020.
In various embodiments, the tissue thickness compensator 11020 can be held in
position by a one
or more longitudinal rails 11019 extending from the deck 11011 of the support
portion 11010. In
at least one embodiment, the longitudinal rails 11019 can be embedded within
the tissue
thickness compensator 11020. In certain embodiments, referring primarily to
FIG. 274, the
tissue thickness compensator 11020 can comprise a longitudinal recess 11029
which can be
configured to receive the longitudinal rails 11019. In at least one such
embodiment, the recess
11029 can be sized and configured to receive the rails 11019 in a press-fit
arrangement, for
example. Such features, further to the above, can be configured to prevent, or
at least limit,
relative lateral movement between the tissue thickness compensator 11020 and
the support
portion 11010 and, in addition, limit the pre-mature release of the tissue
thickness compensator
11020 from the support portion 11010, for example. In various embodiments,
referring now to
FIG. 275, a surgical stapling instrument can comprise, one, a staple cartridge
channel 11170
configured to receive a staple cartridge 11100 and, two, an anvil 11160
rotatably coupled to the
channel 11170. The staple cartridge 11100 can comprise a support portion 11110
and a tissue
thickness compensator 11120. In various embodiments, the tissue thickness
compensator 11120
can be held in position by one or more longitudinal rows of spikes, or teeth,
11119 extending
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from the deck 11111 of the support portion 11110. In at least one embodiment,
the longitudinal
rows of spikes 11119 can be embedded within the tissue thickness compensator
11120.
[0634] With regard to the embodiment illustrated in FIG. 273, further to the
above, the tissue
thickness compensator 11020 of the staple cartridge 11000 can be progressively
released from
the support portion 11010 as the staples are ejected from the staple cavities
10012 defined
therein. More particularly, further to the above, the staples positioned in
the staple cavities
10012 can be ejected sequentially between the proximal end 11001 of the staple
cartridge 11000
and the distal end 11002 of the staple cartridge 11000 such that, as the
staples are being ejected,
the staples can apply an upward biasing force to the tissue thickness
compensator 11020 which
acts to push the tissue thickness compensator 11020 off of the rails 11019. In
such
circumstances, the proximal end 11006 of the tissue thickness compensator
11020 can be
released from the support portion 11010 as the staples are ejected from the
proximal-most staple
cavities 10012. The tissue thickness compensator 11020 can then be
progressively released from
the support portion 11010 as the staples are progressively ejected from the
support portion 11010
between the proximal end 11001 and the distal end 11002 of the staple
cartridge 11000. When
the staples positioned within the distal-most staple cavities 10012 are
ejected from the support
portion 11010, the distal end 11007 of the tissue thickness compensator 11020
can be released
from the support portion 11010. With regard to the embodiment illustrated in
FIG. 275, the
tissue thickness compensator 11120 can be progressively released from the
spikes 1119
extending from the support portion 11110 as the staples are progressively
ejected from the staple
cartridge between the proximal end 11101 and the distal end 11102.
[0635] As discussed above, a tissue thickness compensator can be progressively
released from
the support portion of a staple cartridge as the staples are progressively
ejected from the support
portion and contact the tissue thickness compensator. In various embodiments,
the legs of the
staple, such as staple legs 10032, for example, may be able to pass through
the tissue thickness
compensator without releasing the tissue thickness compensator from the
support portion. In
such embodiments, the tissue thickness compensator may remain engaged with the
support
portion until the bases of the staples, such as bases 10031, contact the
tissue thickness
compensator and push it upwardly. In various embodiments, however, cleats
and/or other
retention features extending from the support portion, for example, may oppose
the release of the
tissue thickness compensator from the support portion. In certain embodiments,
as described in
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greater detail below, a support portion can comprise retention features which
can be configured
to progressively release a tissue thickness compensator from the support
portion as the staples
are progressively fired from the staple cartridge. Referring now to FIG. 283,
a staple cartridge,
such as staple cartridge 11200, for example, can comprise a support portion
11210 including
retention features 11213 which can be configured to releasably hold a tissue
thickness
compensator 11220 (FIG. 284) to the support portion 11210. In various
embodiments, the
retention features 11213 can be positioned at the ends of each staple cavity
11212, for example,
wherein each retention feature 11213 can comprise a guide groove 11216 defined
therein which
is configured to slidably receive a staple leg 10032 of a staple 10030. In
such embodiments,
both the staple legs 10032 and the retention features 11213 can be configured
to releasably retain
the tissue thickness compensator 11220 to the support portion 11210. In use,
referring now to
FIG. 284, staple drivers 10040 contained within the support portion 11210 can
be driven
upwardly by a sled 10050, as described above, wherein the staple drivers 10040
can be
configured to contact the retention features 11213, at least partially detach
the retention features
11213 from the support portion 11210, and displace the retention features
11213 outwardly and
away from the staples 10030 and the staple cavities 11212. When the retention
features 11213
are detached from the support portion 11210 and/or displaced outwardly, as
illustrated in FIG.
284, the retention features 11213 may no longer be able to retain the tissue
thickness
compensator 11220 to the support portion 11210 and, as a result, the tissue
thickness
compensator 11220 can be released from the support portion 11210. Similar to
the above, the
tissue thickness compensator 11220 can be progressively released from the
support portion
11210 as the staples 10030 are progressively ejected from the staple cartridge
toward an anvil,
such as anvil 11260, for example. In various embodiments, the staple drivers
10040 may contact
the retention features 11213 when the top surfaces of the staple drivers 10040
become co-planar,
or at least substantially co-planar, with the deck surface 11211 of the
support portion 11210, for
example. In such embodiments, the tissue thickness compensator 11220 may be
released from
the support portion 11210 at the same time as and/or just before the staples
10030 are formed to
their fully-formed, or fully-fired, configuration. In at least one such
embodiment, referring
primarily to FIG. 285, the drivers 10040 can be overdriven such that they are
pushed above the
deck surface 11211 to fully form the staples 10030 and, during the process of
being overdriven,
break the retention features 11213 away from the support portion 11210. In
various
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embodiments, referring again to FIG. 284, the retention features 11213 may
extend over, or
overhang, into the staple cavities 11212 prior to being detached or displaced
outwardly such that
the drivers 10040 can contact the retention features 11213 just as the drivers
10040 reach the
deck surface 11211. In any event, once the tissue thickness compensator 11220
has been
released from the support portion 11210, referring now to FIG. 285, the
support portion 11210
can be moved away from the implanted tissue thickness compensator 11220.
[0636] As described above, a compressible tissue thickness compensator of a
staple cartridge
can be progressively released from a support portion, or cartridge body, of
the staple cartridge as
the staples are fired, or deployed, from the staple cartridge. In various
circumstances, such a
release can comprise a progressive loosening of the tissue thickness
compensator from the
support portion wherein, in some circumstances, a complete detachment of the
tissue thickness
compensator from the support portion may not occur until the anvil is opened
and the support
portion is moved away from the implanted tissue thickness compensator. In
various
embodiments, referring now to FIG. 289, a staple cartridge, such as staple
cartridge 11300, for
example, can comprise a tissue thickness compensator 11320 which is releasably
retained to a
support portion 11310. In at least one embodiment, the support portion 11310
can comprise a
plurality of retention members 11313 extending therefrom which are configured
to releasably
compress and hold the longitudinal sides of the tissue thickness compensator
11320 to the
support portion 11310. In at least one such embodiment, each retention member
11313 can
comprise an inwardly-facing channel or slot 11316 which can be configured to
receive the
longitudinal sides of the tissue thickness compensator 11320 therein. In
various circumstances, a
plurality of retention members 11313 can extend along a first longitudinal
side of the support
portion 11310 and a plurality of retention members 11313 can extend along a
second
longitudinal side of the support portion 11310 wherein, in certain
circumstances, the retention
members 11313 can be configured to prevent, or at least limit, relative
lateral movement between
the tissue thickness compensator 11320 and the support portion 11310 and, in
addition, prevent,
or at least limit, the premature release of the tissue thickness compensator
11320 from the
support portion 11310. In various embodiments, the retention members 11313 can
be integrally
formed with the support portion 11310 and, in at least one embodiment,
referring to FIG. 290,
the retention members 11313 can be configured to detach, or at least partially
detach, from the
support portion 11310 in order to allow the tissue thickness compensator 11320
to detach from
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the support portion 11310, as illustrated in FIG. 291, for example. In certain
embodiments, an
anvil, such as anvil 11360, for example, can be configured to compress the
tissue thickness
compensator 11320 and, in response to pressure generated within the tissue
thickness
compensator 11320, the tissue thickness compensator 11320 can expand laterally
to at least
partially detach, or disengage, the retention members 11313 from the tissue
thickness
compensator 11320. In various embodiments, the advancement of a knife member,
discussed
above, through the anvil 11360 and the staple cartridge 11300 can deploy the
staples contained
therein and, simultaneously, squeeze the anvil 11360 and the staple cartridge
11300 closer to one
another which can apply an added compressive pressure to the tissue thickness
compensator
11320 and thereby cause the retention members 11313 to sequentially detach as
the knife
member passes through the staple cartridge 11300.
[0637] In various embodiments, referring now to FIGS. 292-294, a staple
cartridge, such as
staple cartridge 11400, for example, can comprise a tissue thickness
compensator 11420
removably attached to a support portion 11410. In at least one embodiment, the
staple cartridge
11400 can comprise one or more retainer bars 11413 which can be configured to
hold the
longitudinal sides of the tissue thickness compensator 11420 to the deck
surface 11411. In at
least one such embodiment, each retainer bar 11413 can comprise opposing arms
11418 which
can define a channel 11416 therebetween. In such embodiments, one of the arms
11418 can be
configured to extend over the tissue thickness compensator 11420 and the other
arm 11418 can
be configured to extend under a lip 11419 extending from the support portion
11410. Referring
primarily to FIG. 292, the channel 11416 of each retainer bar 11413 can be
sized and configured
to apply a compressive force to the longitudinal sides of the tissue thickness
compensator 11420
prior to the staple cartridge 11400 being used. During use, referring
primarily to FIG. 293, the
staple cartridge 11400 can be positioned within a staple cartridge channel
and, once the staple
cartridge 11400 has been suitably positioned, an anvil, such as anvil 11460,
for example, can be
moved into a position in which it can compress the tissue thickness
compensator 11420. Similar
to the above, the thickness tissue compensator 11420, when compressed, can
expand laterally, or
outwardly, and, as a result, detach the retainer bars 11413 from the staple
cartridge 11400. In
certain other embodiments, the closing of the anvil 11460 may not detach, or
may not completely
detach, the retainer bars 11413 from the staple cartridge. In at least one
such embodiment, the
advancement of a firing bar, described above, through the staple cartridge
11400 can deploy the
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staples 10030 from the support portion 11410 and, simultaneously, squeeze the
anvil 11460 and
the staple cartridge 11400 closer together to apply a compressive force to the
tissue thickness
compensator 11420 that is sufficient to cause the tissue thickness compensator
11420 to expand
laterally and detach the retainer bars 11413 from the staple cartridge 11400.
Once the retainer
bars 11413 have been detached from the staple cartridge 11400, referring to
FIG. 294, the
support portion 11410 can be moved away from the implanted tissue thickness
compensator
11420 and removed from the surgical site. In certain alternative embodiments,
referring now to
FIG. 295, a staple cartridge 11400' can comprise retainer bars 11413' which,
similar to the
above, can comprise arms 11418' extending therefrom. In at least one such
embodiment, each of
the arms 11418' can comprise a wedge-lock bevel 11417' which can be configured
to releasably
latch the retainer bars 11413' to the staple cartridge 11400'. More
particularly, in at least one
embodiment, the support portion 11410' of the staple cartridge 11400'can
comprise undercuts
11419' which, in co-operation with the wedge-lock bevels 11417', can be
configured to
releasably retain the retainer bars 11413' to the staple cartridge 11400 and
inhibit the tissue
thickness compensator 11420 from being prematurely detached from the support
portion 11410'.
During use, similar to the above, the retainer bars 11413' can be detached
from the staple
cartridge 11400' when a sufficient compressive force is applied to the tissue
thickness
compensator 11420, for example.
[0638] In various circumstances, as described above and referring again to
FIGS. 259 and 260,
the sled 10050 of the staple cartridge 10000 and the firing member 10052 of a
surgical stapling
instrument can be moved from the proximal end 10001 of the staple cartridge
10000 to the distal
end 10002 (FIG. 219) of the staple cartridge 10000 in order to deploy the
staples 10030 from the
support portion 10010. In at least one such circumstance, each staple 10030
can be moved from
an unfired position to a fired position and ejected from the support portion
10010 to capture the
entirety of the tissue thickness compensator 10020 against the tissue
positioned between the
anvil 10060 and the staple cartridge 10000. In certain circumstances, a
surgeon may not need to
fire all of the staples 10030 from the staple cartridge 10000 and the surgeon
may stop the
progression of the sled 10050 and the firing bar 10052 at a point located
intermediate the
proximal end 10001 and the distal end 10002 of the staple cartridge 10000. In
such
circumstances, the tissue thickness compensator 10020 may only be partially
implanted to the
tissue T and, in order to detach the unimplanted portion of the tissue
thickness compensator
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10020 from the support portion 10010, the surgeon can pull the support portion
10010 away
from the partially implanted tissue thickness compensator 10020 such that the
unimplanted
portion peels or pulls off of the support portion 10010. While such
embodiments arc suitable in
various circumstances, an improvement is illustrated in FIGS. 300-302 wherein
a tissue thickness
compensator, such as tissue thickness compensator 11520 of staple cartridge
11500, for example,
can comprise a plurality of connected segments which can be configured to
detach from one
another. In at least one such embodiment, the tissue thickness compensator
11520 can comprise
a first, or proximal-most, segment 11520a, a second segment 11520b removably
connected to the
first segment 11520a, a third segment 11520c removably connected to the second
segment
11520b, a fourth segment 11520d removably connected to the third segment
11520e, and a fifth
segment 11520e removably connected to the fourth segment 11520d, for example.
In various
embodiments, the tissue thickness compensator 11520 can comprise at least one
thin section
11529 positioned intermediate any two adjacent segments 11520a-11520e which
can be
configured to define a pre-determined rupture or separation point in which the
tissue thickness
compensator segments can separate from one another. In certain embodiments, a
tissue
thickness compensator can include any suitable arrangement of perforations,
thin sections, and/or
any other means for creating a separation point within the tissue thickness
compensator.
Referring primarily to FIG. 301, an anvil 11560 is illustrated in a closed
position and the firing
member 10052 is illustrated as having been partially advanced through the
staple cartridge 11500
such that the staples 10030 underlying the first segment] 1520a, the second
segment 11520b, and
the third segment 11520c have been fired to capture the tissue thickness
compensator 11520
against the tissue T. In such a position, the firing member 10052 has not yet
been advanced to
deploy the staples 10030 underlying the fourth segment 11520d and the fifth
segment 11520e,
for example. Referring now to FIG. 302, the anvil 11560 has been moved into an
open position
and the support portion 11510 of the staple cartridge 11500 has been moved
away from the
portion of the tissue thickness compensator 11520 that has been implanted. As
illustrated in
FIG. 302, the thin section 11529 (FIG. 300) located intermediate the third
segment 11520c and
the fourth segment 11520d has allowed the unimplanted portion of the tissue
thickness
compensator 11520 to separate from the implanted portion.
[0639] In various embodiments, further to the above, a staple cartridge can
comprise a plurality
of fasteners configured to releasably hold a tissue thickness compensator to a
support portion of
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the staple cartridge. In certain embodiments, the support portion can comprise
a plurality of
apertures defined in the deck surface, for example, wherein the fasteners can
extend through the
tissue thickness compensator and can be releasably retained in the support
portion apertures. In
use, the fasteners can be progressively released from the support portion as
the staples are
progressively ejected from the support portion. In at least one such
embodiment, the fasteners
can be implanted with the tissue thickness compensator and, in at least one
embodiment, the
fasteners can be comprised of at least one bioabsorbable material, for
example. In certain
embodiments, the fasteners can detach from the support portion after the
tissue thickness
compensator has been at least partially implanted and as the support portion
is moved away from
the implanted tissue thickness compensator. In various embodiments, referring
now to FIGS.
323-325, a staple cartridge, such as staple cartridge 11600, for example, can
comprise a tissue
thickness compensator 11620 releasably mounted to a support portion 11610 by a
plurality of
fasteners 11613. Each fastener 11613 can comprise a first end 11618 embedded
within and/or
otherwise engaged with the tissue thickness compensator 11620, a second end
11618 engaged
with the support portion 11610, and a connector 11616 which connects the first
end 11618 to the
second end 11618. In various embodiments, the fasteners 11613 can extend
through a knife slot
11615 defined in the support portion 11610. In use, the firing member 10052,
described above,
can move a knife edge through the knife slot 11615 in the support portion
11610 and incise the
fasteners 11613 in order to release the tissue thickness compensator 11620
from the support
portion 11610. In at least one such embodiment, the firing bar 10052 can be
advanced from a
proximal end 11601 of the staple cartridge 11600 to a distal end 11602 of the
staple cartridge
11600 in order to, one, advance the sled 10050 distally and progressively fire
the staples 10030,
as discussed above, and, two, progressively incise and/or break the fasteners
11613 to
progressively release the tissue thickness compensator 11620 from the support
portion 11610. In
certain embodiments, similar to the above, the tissue thickness compensator
11620 can comprise
a plurality of detachable segments 11620a-11620e which can each be held to
support portion
11610 by one or more fasteners 11613, for example. In the event that the
firing member 10052
is stopped intermediate the proximal end 11601 and the distal end 11602 of the
staple cartridge
11600, as illustrated in FIG. 324, the fasteners 11613 can assist in holding
the unimplanted
portion of the tissue thickness compensator 11620 to the support portion 11610
after the anvil
11660 is opened and the support portion 11610 is moved away from the tissue T,
as illustrated in
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FIG. 325. In various embodiments, further to the above, the cutting edge 10053
of the firing
member 10052 can be configured to incise and/or break the fasteners 11613. In
certain
alternative embodiments, referring now to FIGS. 327 and 328, a staple-
deploying sled, such as
sled 11650, for example, can comprise a knife edge 11653 which can be
configured to incise the
connectors 11616 of the fasteners 11613 as the sled 11650 traverses the staple
cartridge 11600.
In at least one such embodiment, each connector 11616 can comprise a
cylindrical member
extending between the T-shaped ends 11618 of the fasteners 11613 wherein the
knife edge
11653 can comprise a concave profile 11653 which can be configured to receive
the cylindrical
connector 11616, for example.
[0640] As discussed above, a staple cartridge can be loaded into a staple
cartridge channel of a
surgical stapling instrument. In various circumstances, a surgeon, or other
clinician, may insert
the staple cartridge into the staple cartridge channel by placing a downward
force onto the staple
cartridge to lock the staple cartridge in place. In some such circumstances,
the clinician may
place their thumb, for example, on the top surface of the staple cartridge to
apply such a
downward force. In various embodiments, the top surface of the staple
cartridge may comprise
the top surface of a tissue thickness compensator wherein, as described above,
the tissue
thickness compensator can be compressible and, in certain embodiments, the
downward force
applied to tissue thickness compensator can cause the tissue thickness
compensator to compress
to the point in which the clinician's thumb comes into contact with the tips
of the staples stored
within the support portion. In various embodiments, a staple cartridge
applicator can be utilized
to insert a staple cartridge into a staple cartridge channel which can be
configured to prevent, or
at least limit, the possibility of the clinician touching the staples in the
staple cartridge. After the
staple cartridge has been suitably positioned within the staple cartridge
channel, as described in
greater detail below, the applicator can be detached from the staple
cartridge.
[0641] In certain embodiments, referring now to FIGS. 305 and 306, a staple
cartridge
applicator can comprise a rigid cover, such as cover 10080, for example, which
can be attached
to a staple cartridge 10000. Further to the above, the cover 10080 can be
configured to prevent,
or at least inhibit, a clinician's thumb, for example, from contacting the
tips of the staples 10030
positioned within the staple cartridge 10000 when the staple cartridge 10000
is inserted into a
staple cartridge channel. Referring now to FIGS. 307 and 308, the cover 10080
can extend over
the top surface 10021, or at least a portion of the top surface 10021, of the
tissue thickness
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compensator 10020 and can include, one, a bottom surface 10081 which can
extend over and/or
abut the tissue thickness compensator 10020 and, two, a top surface 10082
which can provide a
pushing surface for the clinician to apply a downward force thereto, for
example. In use, the
clinician can grab a handle portion 10084 of the cover 10080, align the
support portion 10010 of
the staple cartridge 10000 with the staple cartridge channel, and at least
partially insert the staple
cartridge 10000 within the staple cartridge channel. Thereafter, the clinician
can completely seat
the staple cartridge 10000 in the staple cartridge channel by applying the
downward force to the
top surface 10082 of the cover 10880 which can, in various embodiments,
transmit the
downward force directly to the support portion 10010. In at least one such
embodiment, the
cover 10080 can comprise proximal supports 10087 which can extend downwardly
and contact
the deck surface 10011 of the support portion. In certain embodiments, the
cover 10080 can
further comprise a distal support portion 10083 which can be configured to
abut the nose 10003.
When a downward force is applied the cover 10080, the downward force can be
transmitted
through the proximal supports 10087 and/or the distal support portion 10083
without
transmitting, or at least without substantially transmitting, the downward
force to the support
portion 10010 through the tissue thickness compensator 10020. In various
circumstances, as a
result of the above, the clinician may not directly contact the tissue
thickness compensator
10020. Also as a result of the above, the cover 10080 may not compress, or at
least substantially
compress, the tissue thickness compensator 10020 as the staple cartridge 10000
is being inserted
into the staple cartridge channel. In various embodiments, a cover can
comprise any suitable
number of supports which are configured to transmit a downward force to the
support portion
without transmitting, or at least substantially transmitting, the downward
force through the tissue
thickness compensator. In certain embodiments, the supports can extend around
the distal end,
the proximal end, and/or the longitudinal sides of the tissue thickness
compensator. In some
embodiments, the supports can extend through the tissue thickness compensator.
In at least one
such embodiment, the supports can extend through apertures within the tissue
thickness
compensator and abut the deck of the support portion. In certain embodiments,
at least some of
the supports may not be in contact with the deck before the downward force is
applied to the
cover; however, in various embodiments, the cover can be configured to flex,
or move,
downwardly until the supports contact the deck of the support portion. At such
point, the
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downward flexure, or movement, of the cover can be impeded, or at least
substantially impeded,
from flexing further.
[0642] As described above, the cover 10080 can be attached to the staple
cartridge 10000 and
can be used to manipulate the position of the staple cartridge 10000. In
various embodiments,
the cover 10080 can comprise any suitable number of gripping members which can
be
configured to releasably hold the cover 10080 to the support portion 10010 of
the staple cartridge
10000, for example. In at least one such embodiment, the cover 10080 can
further comprise one
or more retention members, such as latch arms 10088 and/or 10089, for example.
In various
embodiments, the latch arms 10089 can be configured to extend around the sides
of the nose
10003 and engage the bottom surface 10009 (FIG. 306) of the nose 10003.
Similarly, the latch
arms 10088 can extend around the sides of lock projections 10008 extending
from the support
portion 10010 and engage the bottom surfaces of the lock projections 10008.
These latch arms,
in various embodiments, can be configured to position the cover 10080 over the
zone or region
in which the staples are stored within the support portion 10010. In any
event, once the staple
cartridge 10000 has been suitably positioned, the cover 10080 can be detached
from the staple
cartridge 10000. In at least one embodiment, the clinician can apply an upward
lifting force to
the handle 10084 in order to detach the distal end of the cover 10080 from the
distal end 10002
of the staple cartridge 10000. In at least one such embodiment, the latch arms
10088 and 10089
can flex outwardly as the handle 10084 is lifted upwardly such that the latch
arms 10088 and
10089 can flex around the lock projections 10008 and the nose 10003,
respectively. Thereafter,
the proximal end of the cover 10080 can be lifted away from the proximal end
10001 of the
staple cartridge and the cover 10080 can be moved away from the staple
cartridge 10000.
[0643] In certain embodiments, referring now to FIGS. 309 and 310, a staple
cartridge
applicator, such as staple cartridge applicator 10680, for example, can be
configured to position
an upper tissue thickness compensator, such as tissue thickness compensator
10690, for example,
relative to an anvil in addition to positioning a staple cartridge, such as
staple cartridge 10600,
for example, within a staple cartridge channel. Similar to the above, the
applicator 10680 can
comprise latch arms 10688 which can be releasably engaged with lock
projections 10608
extending from a support portion 10610 of the staple cartridge 10600 such that
the applicator
10680 can be maintained in position over a tissue thickness compensator 10620
of the staple
cartridge 10600. In various embodiments, the upper tissue thickness
compensator 10690 can be
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removably attached to the staple cartridge applicator 10680 such that the
anvil of a surgical
instrument, such as anvil 10060, for example, can be closed onto the
applicator 10680, engage
the tissue thickness compensator 10690, and detach the tissue thickness
compensator 10690 from
the applicator 10680. In various embodiments, the tissue thickness compensator
10690 and/or
the anvil 10060 can comprise one or more retention features which can be
configured to
releasably hold the tissue thickness compensator 10690 to the anvil 10060. In
at least one such
embodiment, the tissue thickness compensator 10690 can comprise a longitudinal
rail 10695, for
example, extending from the top surface 10691 of the tissue thickness
compensator 10690 which
can be received within a longitudinal knife slot 10065 defined within the
anvil 10060. In various
embodiments, the tissue thickness compensator 10690 and the longitudinal rail
10695 can be
comprised of any suitable compressible material, such as those described in
the this patent
application, for example, wherein the longitudinal rail 10695 can be
compressed and/or wedged
within the knife slot 10065, for example. Once the anvil 10060 has been
engaged with the tissue
thickness compensator 10690, the anvil 10060 can be returned to an open
position and, in such
circumstances, the tissue thickness compensator 10690 can detach from the
applicator 10680.
Thereafter, the applicator 10680 can be detached from the staple cartridge
10600 such that the
anvil 10060 and the staple cartridge 10600 can be positioned relative to the
tissue that is to be
stapled and/or incised. In use, a staple-deploying sled, such as sled 10050
(FIG. 236), for
example, can be advanced distally through the staple cartridge 10600 by a
firing member 10052
(FIG. 236), for example, in order to eject the staples from the staple
cartridge 10060, as outlined
above. As the staples are deformed, each staple can capture a portion of the
tissue thickness
compensator 10690 against the top surface of the tissue and a portion of the
tissue thickness
compensator 10620 against the bottom surface of the tissue. At the same time,
the firing member
10052 can advance a knife edge 10053 (FIG. 236) through the tissue thickness
compensator
10620 and/or the tissue thickness compensator 10690 wherein, in at least one
embodiment, the
knife edge 10053 can be advanced through the longitudinal rail 10695 in order
to incise the rail
10695 and progressively detach the tissue thickness compensator 10690 from the
anvil 10060.
After the staples have been deployed, the anvil 10060 can be re-opened and
moved away from
the implanted tissue thickness compensator 10690 and, similarly, the support
portion 10610 of
the staple cartridge 10600 can be moved away from the implanted tissue
thickness compensator
10620. In various embodiments, further to the above, the tissue thickness
compensator 10620
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and/or the tissue thickness compensator 10690 can comprise a plurality of
detachable segments
which can be configured to separate from one another in the event that only
portions of the tissue
thickness compensators 10620 and 10690 are implanted by the staples.
[0644] In various embodiments, further to the above, the applicator 10680 can
comprise one or
more retention features which can be configured to releasably hold the tissue
thickness
compensator 10690 to the applicator 10680. In at least one such embodiment,
referring primarily
to FIG. 310, the applicator 10680 can comprise a longitudinal retention rail
10685 which can be
configured to be received in a longitudinal retention slot 10694 defined in
the bottom surface
10692 of the tissue thickness compensator 10690 in a press-fit manner, for
example. In various
circumstances, the retention rail 10685 and the retention slot 10694 can be
configured to retain
the tissue thickness compensator 10690 to the applicator 10680 until a
sufficient upward lifting
force is applied to the tissue thickness compensator 10690 by the anvil 10060,
as described
above. In at least one such embodiment, the retention rail 10685 extending
from the applicator
10680 can further comprise end stops 10686 positioned at the proximal and
distal ends of the
retention rail 10685 which can be configured to prevent, or at least limit,
relative longitudinal
movement between the tissue thickness compensator 10690 and the applicator
10680. In certain
embodiments, referring again to FIG. 310, one or more adhesives, such as
longitudinal adhesive
strips 10693, for example, can be placed on the contact surface 10691 of the
tissue thickness
compensator 10690 such that, when the anvil 10060 contacts the tissue
thickness compensator
10690, as described above, the adhesive can releasably attach the tissue
thickness compensator
10690 to the anvil 10060. In various embodiments, one or more adhesives can be
utilized in
addition to or in lieu of the compressible retention features described above,
for example. In
certain embodiments, one or more adhesives can be utilized to releasably hold
a tissue thickness
compensator to a staple cartridge applicator. In at least one embodiment,
referring now to FIG.
310A, the cover 10080, for example, can include one or more adhesive pads
12185 which can be
configured to releasably retain an upper tissue thickness compensator, such as
tissue thickness
compensator 12190, for example, to the top surface 10082 of the cover 10080.
In at least one
such embodiment, similar to the embodiments described above, an anvil can be
closed onto to
the tissue thickness compensator 12190 to engage the longitudinal retention
rail 12195 of the
tissue thickness compensator 12190. In certain embodiments, a release
mechanism can be
positioned intermediate the tissue thickness compensator 12190 and the cover
10080 which can
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be utilized to break the adhesive bonds holding the tissue thickness
compensator 12190 to the
cover 10080 and detach the tissue thickness compensator 12190 from the cover
10080. In at
least one embodiment, the release mechanism can comprise a pull tab 12196 and
a loop 12197
wherein the loop 12197 can comprise first and second ends which are attached
to the pull tab
12196. The loop 12197 can comprise a suture, for example, which can define a
perimeter which
circumscribes the adhesive pads 12185 such that, when the pull tab 12196 is
pulled distally, the
suture can slide between the tissue thickness compensator 12190 and the cover
10080 and
contact the tissue pads 12185. In such circumstances, the suture can at least
one of separate the
adhesive pads 12185 from the tissue thickness compensator 12190, separate the
adhesive pads
12185 from the cover 10080, and/or sever the adhesive pads 12185, for example.
[0645] In various embodiments, referring now to FIG. 311, a staple cartridge
can comprise a
support portion 10710, for example, which, similar to the above, can comprise
a longitudinal
knife slot 10715 extending therethrough. In at least one such embodiment, a
staple cartridge
applicator, such as applicator 10780, for example, can comprise a longitudinal
retention and
alignment member 10786 which can extend into the knife slot 10715 in the
support portion
10710. In certain embodiments, the retention member 10786 can be configured to
engage the
sidcwalls of the knife slot 10715 in a press-fit manner, for example, such
that the applicator
10780 can be rcleasably retained to the support portion 10710. In various
embodiments,
although not illustrated, a first portion of a tissue thickness compensator
can be positioned on a
first side of the retention member 10786 and a second portion of the tissue
thickness
compensator can be positioned on an opposite, or second, side of the retention
member 10786.
Similar to the above, the first and second portions of the tissue thickness
compensator can be
mounted to the support portion 10710 of the staple cartridge via retention
members 10013, for
example. Also similar to the above, an upper tissue thickness compensator
10790 can be
removably mounted to the applicator 10780 via a longitudinal retention member
10785
extending from the loading surface 10782 of the applicator 10780 wherein the
retention member
10785 can be releasably press-fit into a longitudinal slot 10794 defined in
the bottom surface
10792 of the tissue thickness compensator 10790, for example. In various
embodiments, also
similar to the above, the tissue thickness compensator 10790 can further
comprise a longitudinal
retention member 10795 extending from the top surface 10791 of the tissue
thickness
compensator 10790 which can be releasably retained in the longitudinal knife
slot 10065 defined
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in the anvil 10060, for example. In at least one such embodiment, the
longitudinal retention
member 10795 can comprise a wedge-shaped cross-section comprising a top
portion which is
larger than a bottom portion, wherein the bottom portion can attach the
retention member 10795
to the tissue thickness compensator 10790, for example.
[0646] In various embodiments, referring now to FIGS. 312 and 313, a staple
cartridge 10800
comprising a support portion 10810 and a tissue thickness compensator 10820
can be loaded into
a staple cartridge channel with a staple cartridge applicator 10880, for
example. Similar to the
above, the staple cartridge applicator 10880 can also be configured to
position an upper tissue
thickness compensator 10890, for example, relative to an anvil, such as anvil
10060, for
example, such that, when the anvil 10060 is closed, the anvil 10060 can
contact and engage the
tissue thickness compensator 10890. In at least one embodiment, the tissue
thickness
compensator 10890 can comprise a plurality of retention legs 10895 extending
from the top
surface 10891 of the tissue thickness compensator 10890 which can be
configured to be engage
the anvil 10060 and releasably retain the tissue thickness compensator 10890
to the anvil 10060.
In at least one such embodiment, the legs 10895 can be arranged in a
longitudinal row wherein
each leg 10895 can comprise at least one foot configured to enter into and
engage the knife slot
10065 defined in the anvil 10060. In certain embodiments, some of the feet of
legs 10895 can
extend in one direction while other feet can extend in another direction. In
at least one
embodiment, some of the feet can extend in opposite directions. In any event,
once the anvil
10060 has been engaged with the tissue thickness compensator 10890, referring
now to FIGS.
313 and 314, the anvil 10060 can be reopened and the clinician can move the
staple cartridge
applicator 10880 away from the tissue thickness compensators 10820 and 10890.
Thereafter,
referring to FIG. 314A, the upper tissue thickness compensator 10890 can be
positioned on a
first side of the targeted tissue and the tissue thickness compensator 10820,
which can comprise a
lower tissue thickness compensator, can be positioned on a second side of the
tissue. After the
tissue thickness compensators 10820 and 10890 have been suitably positioned,
referring now to
FIG. 314B, a knife edge of a firing member, such as knife edge 10053, for
example, can be
advanced through the tissue and the tissue thickness compensators. In various
embodiments,
referring now to FIG. 318, a staple cartridge applicator, such as applicator
12280, for example,
can comprise a tissue thickness compensator 12290 detachably mounted thereto
which can be,
similar to the above, inserted into a staple cartridge channel, as illustrated
in FIG. 319, and
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engaged by the anvil 10060 when the anvil 10060 is moved into a closed
position. In at least one
such embodiment, the tissue thickness compensator 12290 can comprise a
plurality of retention
members 12295 extending upwardly from the top surface 12291 of the tissue
thickness
compensator 12290 wherein each retention member 12295 can comprise a plurality
of flexible
legs 12296 which can be configured to be inserted into the knife slot 10065 in
the anvil 10060.
Referring primarily to FIGS. 321 and 322, the flexible legs 12296 of each
retention member
12295 can be separated by a gap 12298 such that, as the legs 12296 are
inserted into the knife
slot 10065, the legs 12296 can flex inwardly and then resiliently return
outwardly once the
enlarged feet of the flexible legs 12296 have passed through the knife slot
10065. In various
embodiments, the enlarged feet of the flexible legs 12296 can flex behind
opposing retention lips
12297 defined in the anvil 10060 and, as a result of the interaction of the
legs 12296 and the lips
12297, the tissue thickness compensator 12290 can be retained to the anvil
10060. Thereafter,
the staple cartridge applicator 12280 can be moved away from the tissue
thickness compensator
12290, as illustrated in FIG. 320. In use, once the tissue thickness
compensator 12290 has been
implanted against the tissue by staples deployed from staple cartridge 10000,
for example, the
anvil 10060 can be re-opened and, as the anvil 10060 is moved away from the
implanted tissue
thickness compensator 12290, the legs 12296 of the retention members 12995 can
flex inwardly
such that they can be pulled out of the knife slot 10065.
[0647] In various embodiments, referring now to FIGS. 315 and 316, a tissue
thickness
compensator, such as tissue thickness compensator 11990, for example, can be
loaded
longitudinally into an anvil, such as anvil 11960, for example. More
particularly, in at least one
embodiment, the tissue thickness compensator 11990 can comprise one or more
longitudinal
rails 11995 which can be inserted into a distal opening in a knife slot 11965
of the anvil 11960
and then pushed proximally until the tissue thickness compensator 11990 has
been properly
seated in the anvil 11960. In at least one such embodiment, each rail 11995
can comprise a
longitudinal retention foot 11996 which can be positioned behind a
longitudinal retention lip
11997 which at least partially defines the knife slot 11965, for example. As
illustrated in FIG.
316, the feet 11996 can extend in opposite directions in order to be
positioned behind retention
lips 11997 positioned on the opposite sides of the knife slot 11965. In
various embodiments, a
longitudinal gap 11998 can be defined between the rails 11995 which can be
configured to
permit the rails 11995 to flex inwardly toward one another when the tissue
thickness
208
compensator 11990 is detached from the anvil 11960. In certain embodiments,
referring now to
FIG. 317, a tissue thickness compensator, such as tissue thickness compensator
12090, for
example, can comprise one or more lock arms 12098 which can extend around the
sides of an
anvil, such as anvil 12060, for example. In use, the lock arms 12098 can
engage the anvil 12060
and releasably retain the tissue thickness compensator 12090 to the anvil
12060. In at least one
such embodiment, the anvil 12060 can comprise one or more notches, or lock
shoulders, 12097,
for example, which can each be configured to receive a foot extending from a
lock arm 12098.
In use, the arms 12098 can flex outwardly and detach from the anvil 12060 when
the anvil 12060
is moved away from the tissue thickness compensator 12090 after the tissue
thickness
compensator 12090 has been at least partially implanted.
106481 As described above, a surgical stapling instrument can comprise a
staple cartridge
channel configured to receive a staple cartridge, an anvil rotatably coupled
to the staple cartridge
channel, and a firing member comprising a knife edge which is movable relative
to the anvil and
the staple cartridge channel. In use, a staple cartridge can be positioned
within the staple
cartridge channel and, after the staple cartridge has been at least partially
expended, the staple
cartridge can be removed from the staple cartridge channel and replaced with a
new staple
cartridge. In some such embodiments, the staple cartridge channel, the anvil,
and/or the firing
member of the surgical stapling instrument may be re-used with the replacement
staple cartridge.
In certain other embodiments, a staple cartridge may comprise a part of a
disposable loading unit
assembly which can include a staple cartridge channel, an anvil, and/or a
firing member, For
example, which can be replaced along with the staple cartridge as part of
replacing the
disposable loading unit assembly. Certain disposable loading unit assemblies
arc disclosed in
U.S. Patent Application Serial No. 12/031,817, now U.S. Publication No. 2009-
0206131, entitled
END EFECTOR COUPLING ARRANGMENTS FOR A SURGICAL CUTFING AND
STAPLING INSTRUMENT, which was filed on February 15, 2008. Referring now to
FIG. 370,
a disposable loading unit, such as disposable loading unit 12500, for example,
can comprise a
support portion 12510, an anvil 12560 rotatably coupled to the support portion
12510, and an
elongate shaft 12570 extending from the support portion 12510. Similar to the
staple cartridges
described herein, the support portion 12510 can comprise a plurality of staple
cavities 10012 and
a staple, such as a staple 10030, for example, positioned in each staple
cavity 10012, for
example. The disposable loading unit 12500 can further
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comprise a firing member 12552 which can be advanced distally in order to move
the anvil
12560 from an open position, as illustrated in FIG. 370, to a closed position.
In various
embodiments, the disposable loading unit 12500 can further comprise a tissue
thickness
compensator 12520 positioned on and/or attached to the support portion 12510
wherein, when
the anvil 12560 is in its closed position, the anvil 12560 can be positioned
opposite the tissue
thickness compensator 12520 and, in some embodiments, the anvil 12560 can at
least partially
compress the tissue thickness compensator 12520 when the anvil 12560 is in its
closed position.
In either event, the firing member 12552 can be advanced further in order to
eject the staples
from the support portion 12510. As the staples are ejected, the staples can be
deformed by the
anvil 12560 and trap at least a portion of the tissue thickness compensator
12520 therein.
Thereafter, the firing member 12552 can be retracted proximally, the anvil
12560 can be re-
opened, and the support portion 12510 can be moved away from the implanted
tissue thickness
compensator 12520.
[0649] In various embodiments, further to the above, the tissue thickness
compensator 12520
can be detachably mounted to the support portion 12510. In at least one such
embodiment, the
support portion 12510 can comprise a longitudinal retention rail 12526 mounted
to each side
thereof wherein each rail 12526 can comprise one or more apertures 12528 which
can be
configured to receive at least a portion of the tissue thickness compensator
12520 therein. Once
the tissue thickness compensator 12520 has been at least partially implanted,
the tissue thickness
compensator 12520 can pull out of the apertures 12528 as the support portion
12510 is moved
away. In various embodiments, referring now to FIGS. 371-373, a disposable
loading unit 12600
can comprise a support portion 12610, a tissue thickness compensator 12620
detachably
mounted to the support portion 12610, and one or more retention rails 12626
which can be
configured to extend under the tissue thickness compensator 12620 and mount
the tissue
thickness compensator 12620 to the support portion 12610. Each retention rail
12626 can
comprise a plurality of retention hooks 12628, for example, which can be
engaged to the support
portion 12610 via retention slots 12614, for example, defined in the support
portion 12610. In
use, in at least one such embodiment, the tissue thickness compensator 12620
can be configured
to detach from the retention rails 12626 after the tissue thickness
compensator 12620 has been at
least partially implanted and the support portion 12610 is moved away from the
tissue thickness
compensator 12620. In various embodiments, referring now to FIGS. 374-376, a
disposable
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loading unit 12700 can comprise one or more retention rails 12726 which can
each comprise a
bottom bar 12725 which can extend under the tissue thickness compensator 12720
and a top bar
12727 which can extend over the top surface 12621 of the tissue thickness
compensator 12620.
In certain embodiments, the tissue thickness compensator 12620 can be at least
partially
compressed between the top bars 12727 and the bottom bars 12725 such that the
retention rails
12726 can releasably hold the tissue thickness compensator 12620 relative to
the support portion
12610. In at least one such embodiment, each retention rail 12726 can comprise
one or more
retention hooks 12728 which can be engaged with the support portion 12610 to
retain the
retention rails 12726 to the support portion 12610.
[0650] In various embodiments, referring now to FIGS. 377 and 378, a
disposable loading unit
12800 can comprise a retention member 12822 which can be configured to mount a
tissue
thickness compensator 12620 to the support portion 12610. In at least one such
embodiment, the
retention member 12822 can comprise a sheet of material positioned against the
deck surface
12611 of the support portion wherein the tissue thickness compensator 12620
can be attached to
the sheet of material by at least one adhesive, for example. The retention
member 12822 can
further comprise a longitudinal retention rail 12825 configured to extend
downwardly into a
knife slot 12615 defined in the support portion 12610. In at least one such
embodiment, the
retention rail 12825 can be sized and configured such that it is compressed
between the sidewalls
of the knife slot 12615. In use, the firing member 12552 can comprise a knife
edge which can
pass through the knife slot 12615 as the firing member 12552 is advanced
distally and transect
the tissue thickness compensator 12620 and the retention rail 12825
longitudinally. Also, in use,
the staples ejected from the support portion 12610 can penetrate the retention
member 12822, the
tissue thickness compensator 12820, and the tissue positioned between the
tissue thickness
compensator 12820 and the anvil 12560. In various embodiments, the retention
member 12822
can be comprised of a biocompatible and/or bioabsorbable material. In certain
embodiments, the
retention member 12822 can be comprised of a sufficiently compressible
material to comprise a
tissue thickness compensator underlying the tissue thickness compensator
12620. In various
embodiments, referring now to FIGS. 379-381, a disposable loading unit 12900
can comprise a
loading assembly including a bottom portion 12922 which can be removably
attached to the
support portion 12610, a top portion 12990 which can be removably attached to
the anvil 12560,
and a flexible joint 12991 connecting the bottom portion 12922 and the top
portion 12990.
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Similar to the above, a longitudinal retention rail 12825 can extend
downwardly from the bottom
portion 12922 and into the knife slot 12615 defined in the support portion
12610 such that the
bottom portion 12922 can be releasably retained to the support portion 12610.
Similarly, a
longitudinal retention rail 12995 can extend upwardly from the top portion
12990 into a knife
slot defined in the anvil 12560 such that the top portion 12990 can be
releasably retained to the
anvil 12560. As illustrated in FIGS. 380 and 381, a tissue thickness
compensator 12620 can be
mounted to the bottom portion 12922 of the loading assembly wherein, in order
to position the
tissue thickness compensator 12620 relative to the support portion 12610, a
clinician could flex
the top portion 12990 and the bottom portion 12922 toward one another,
position the loading
assembly between the anvil 12560 and the support portion 12610, and release
the flexed loading
assembly such that it can resiliently expand and bias the top portion 12990
against the anvil
12560 and the bottom portion 12922 against the support portion 12610. In at
least one
embodiment, referring now to FIGS. 382-384, the loading assembly can further
comprise one or
more latch hooks, such as latch hooks 12994, for example, extending therefrom
which can be
configured to releasably connect the top portion 12990 to the anvil 12560
and/or releasably
connect the bottom portion 12922 to the support portion 12610.
[0651] In various embodiments, referring now to FIG. 385, a disposable loading
unit 15900,
for example, can comprise an anvil 15960 and a staple cartridge channel 15970
wherein the
staple cartridge channel 15970 can rotate relative to the anvil 15960. In at
least one such
embodiment, the anvil 15960 may not be able to rotate. In certain embodiments,
tissue can be
positioned between the anvil 15960 and the staple cartridge channel 15970 and,
thereafter, the
staple cartridge channel 15970 can be rotated toward the tissue to clamp the
tissue against the
anvil. In at least one such embodiment, the disposable loading unit 15900 can
further comprise a
tissue thickness compensator 15920 which can be configured to contact the
tissue.
[0652] As discussed above and referring to FIG. 332, a staple cartridge, such
as staple cartridge
10000, for example, can comprise a support portion 10010 and a tissue
thickness compensator
10020 wherein a plurality of staples 10030 can be at least partially stored in
the support portion
10010 and can extend into the tissue thickness compensator 10020 when the
staples 10030 are in
their unfired position. In various embodiments, the tips of the staples 10030
do not protrude
from the tissue thickness compensator 10020 when the staples 10030 are in
their unfired
positions. As the staples 10030 are moved from their unfired positions to
their fired positions by
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the staple drivers 10040, as discussed above, the tips of the staples 10030
can penetrate through
the tissue thickness compensator 10020 and/or penetrate through the upper
layer, or skin, 10022.
In certain alternative embodiments, the tips of the staples 10030 can protrude
through the top
surface of the tissue thickness compensator 10020 and/or skin 10022 when the
staples 10030 are
in their unfired position. In either event, the staples 10030, as they extend
upwardly out of the
support portion 10010 prior to being deployed, may tilt and/or deflect
relative to the support
portion, as also discussed above. In various embodiments, referring now to
FIG. 329, a staple
cartridge, such as staple cartridge 13000, for example, can comprise a
plurality of guide
members, or retainers, which can be configured to limit relative movement
between the support
portion 13010 of the staple cartridge 13000 and the tips of the staples
positioned therein.
Referring primarily to FIG. 330, the staple cartridge 13000 can comprise a
tissue thickness
compensator 13020 mounted to a support portion 13010 and, in addition, a
plurality of pledgets
13022 attached to the top surface 13021 of the tissue thickness compensator
13020. In various
embodiments, each pledget 13022 can comprise a plurality of apertures 13029
defined therein
which can be configured to slidably receive and/or guide the legs 13022 of a
staple 13030
therein. In addition to or in lieu of the apertures, a pledget can comprise
any suitable opening
such as a slot, guide, and/or groove, for example, which can be configured to
slidably receive
and/or guide the legs 13022. In certain embodiments, as illustrated in FIG.
330, the tips of the
staple legs 13032 can be positioned within the apertures 13029 when the
staples 13030 are in
their unfired positions. In at least one such embodiment, the tips of the
staple legs 13032 can
protrude above the pledgets 13022 when the staples are in their unfired
position. In certain other
embodiments, the tips of the staple legs 13032 may be positioned just below
the pledgets 13022
when the staples 13030 are in their unfired positions such that, when the
staples 13030 are
moved upwardly through the tissue thickness compensator 13020, the staple legs
13032 can enter
into the apertures 13029 of the pledgets 13022 and slide therethrough. In any
event, when the
legs 13032 of the staples 13030 are positioned within the pledgets, the
lateral and/or longitudinal
movement of the staple legs 13032 can be limited without preventing the upward
movement of
the staple legs 13032 when the staples 13030 are deployed. When the staples
13030 are
deployed, referring now to FIG. 331, the staple legs 13032 can slide upwardly
through the
pledgets 13022 to penetrate the tissue T, contact an anvil positioned opposite
the staple cartridge
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13030, and deform downwardly to capture the tissue T and the tissue thickness
compensator
13030 therein.
[0653] In various embodiments, further to the above, the pledgets 13022 can be
attached to the
tissue thickness compensator 13020 utilizing at least one biocompatible and/or
bioabsorbable
adhesive, for example. In certain embodiments, the pledgets 13022, and/or a
retention member
extending from each pledget, can be at least partially embedded within the
tissue thickness
compensator 13020. In at least one such embodiment, the tissue thickness
compensator 13020
can comprise pockets defined therein which are configured to at least
partially receive a pledget
13022. In certain embodiments, the tissue thickness compensator 13020 can be
integrally
molded, or formed around, the pledgets 13022 during a molding manufacturing
process. In
various embodiments, the pledgets 13022 may comprise discrete retainers that
can move
independently of one another. In at least one embodiment, referring primarily
to FIG. 330, each
pledget 13022 can comprise interlocking and/or keyed features which can be
configured to
permit and, to a certain extent, limit relative lateral and longitudinal
movement between the
pledgets 13022. In at least one such embodiment, each pledget 13022 can
comprise a projection
13026 and one or more recesses 13027, for example, wherein the projection
13026 of a first
pledget 13022 can be positioned within and/or aligned with respect to the
recesses of 13027 of
adjacent second and third pledgets 13022. In various embodiments, gaps can be
present between
adjacent pledgets 13022 which can permit the pledgets 13022 to move or slide
relative to one
another until they contact an adjacent pledget 13022. In certain embodiments,
the pledgets
13022 can be loosely interconnected. In various embodiments, the pledgets
13022 can be
detachably connected to one another. In at least one such embodiment, the
pledgets 13022 can
be manufactured as a sheet of interconnected pledgets wherein, when a
sufficient force is applied
to the sheet, one or more of the pledgets 13022 can break away from the
others. In certain
embodiments, referring again to FIG. 329, a first sheet 13024 of pledgets
13022 can be
positioned on a first side of a longitudinal slot 13025 and a second sheet
13024 of pledgets
13022 can be positioned on a second side of slot 13025. In at least one
embodiment, further to
the above, the longitudinal slot 13025 extending through the tissue thickness
compensator 13020
can be configured to facilitate the passage of a knife edge of a firing member
through the tissue
thickness compensator 13020 and, as the firing member passes thereby, the
firing member can
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apply a compressive force to the sheets 13024 and separate or singulate at
least some of the
pledgets 13022.
[0654] In various embodiments, the pledgets 13022 can be comprised of a
biocompatible
and/or bioabsorbable plastic, for example. In certain embodiments, the
pledgets 13022 can be
comprised of a solid material, a semi-solid material, and/or a flexible
material, for example. In
certain embodiments, the pledgets 13022 can be embedded within a tissue
thickness compensator
such that the pledgets 13022 move with the tissue thickness compensator. In at
least one such
embodiment, the pledgets 13022 can be sufficiently flexible such that they can
flex with the top
surface of the tissue thickness compensator. In certain embodiments, the
pledgets 13022 can be
configured to remain embedded in the tissue thickness compensator while, in
certain other
embodiments, the pledgets 13022 can be configured to pop out of, or detach
from, the tissue
thickness compensator. In various embodiments, the pledges 13022 can comprise
a top surface
which is flush with the top surface of the tissue thickness compensator. In
certain embodiments,
the top surfaces of the pledgets 13022 can be positioned above and/or below
the top surface of
the tissue thickness compensator. In various embodiments, the top surfaces of
the pledgets
13022 can be disposed such that they are visible when viewing the top surface
of the tissue
thickness compensator while, in other embodiments, the top surfaces of the
pledgets 13022 can
be positioned below a layer of the tissue thickness compensator, for example.
In certain
embodiments, guide features can be molded into the top surface of a tissue
thickness
compensator, for example. In at least one such embodiment, the tissue
thickness compensator
may not comprise a composite material and may comprise a unitary piece of
material, for
example.
[0655] In various embodiments, referring now to FIG. 338, a staple cartridge
can comprise a
tissue thickness compensator 13620 and a skin, or top layer, 13621, for
example. In at least one
such embodiment, one or more pledgets, or retainers, 13622, for example, can
be embedded in
the skin 13621. In certain embodiments, each retainer 13622 can comprise one
or more
apertures 13629 defined therein which can be configured to receive the staple
legs 13032 of
staples 13030 therein when the staples 13030 are in their unfired position, as
illustrated in FIG.
338. In use, further to the above, the staple legs 10032 can slide through the
apertures 13629
when the staples 13030 are moved from their unfired position to their fired
position until the
bases 13031 of the staples 13030 contact the tissue thickness compensator
13620 and compress
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at least a portion of the tissue thickness compensator 13620 against the
bottom surfaces of the
pledgets 13622, for example. In various embodiments, referring now to FIG.
333, a staple
cartridge can comprise a tissue thickness compensator 13120 and a skin, or top
layer, 13122, for
example. In at least one such embodiment, the tissue thickness compensator
13120 can comprise
conical bumps, projections, and/or protrusions 13128, for example, which can
extend upwardly
from the top surface 13121 of the tissue thickness compensator 13120. The
projections 13128
can be configured to receive and envelop the tips of the staple legs 13032 of
the staples 13030
when the staples 13030 are in their unfired position, as illustrated in FIG.
333. The top layer
13122 can also comprise conical bumps, projections, and/or protrusions 13129
which can be
aligned, or at least substantially aligned, with the projections 13128. In
use, the staple legs
10032 can penetrate the projections 13128 and 13129 and emerge from the tissue
thickness
compensator 13120. In various embodiments, referring now to FIG. 337, a staple
cartridge can
comprise a tissue thickness compensator 13520 and a skin, or top layer, 13522,
for example. In
at least one such embodiment, the skin 13522 can comprise conical bumps,
projections, and/or
protrusions 13529, for example, which can extend upwardly from the top surface
13521 of the
tissue thickness compensator 13520. Similar to the above, the projections
13529 can be
configured to receive and envelop the tips of the staple legs 13032 of the
staples 13030 when the
staples 13030 are in their unfired position, as illustrated in FIG. 337. In
use, the staple legs
10032 can penetrate the projections 13529 and emerge from the skin 13522.
[0656] In various embodiments, referring now to FIG. 334, a staple cartridge
can comprise a
tissue thickness compensator 13220 and a skin, or top layer, 13222, for
example. In at least one
such embodiment, the tissue thickness compensator 13220 can comprise conical
dimples and/or
recesses 13128, for example, which can extend downwardly into the top surface
13221 of the
tissue thickness compensator 13220. In various embodiments, the tips of the
staple legs 13032
can extend through the recesses 13128 when the staples 13030 are in their
unfired position, as
illustrated in FIG. 334. In at least one embodiment, the top layer 13222 can
also comprise
conical dimples and/or recesses 13229 which can be aligned, or at least
substantially aligned,
with the recesses 13228. In various embodiments, referring now to FIG. 335, a
staple cartridge
can comprise a tissue thickness compensator 13320 and a skin, or top layer,
13322, for example.
In at least one such embodiment, the skin 13320 can comprise thick portions
13329 which can
extend downwardly into the top surface 13321 of the tissue thickness
compensator 13320. In
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various circumstances, the thick portions 13329 can be configured to receive
at least a portion of
the staple legs 13032 of the staples 13030 therein when the staples 13030 are
in their unfired
position, as illustrated in FIG. 335. In such embodiments, the thick portions
13329 can hold the
staple legs 13032 in position such that the legs 13032 are aligned, or at
least substantially
aligned, with the staple-forming pockets of an anvil positioned opposite the
tissue thickness
compensator 13320. In various embodiments, referring now to FIG. 336, a staple
cartridge can
comprise a tissue thickness compensator 13420 and a skin, or top layer, 13422,
for example. In
at least one such embodiment, the skin 13422 can comprise thick portions 13429
which can
extend upwardly from the top surface 13421 of the tissue thickness compensator
13420. In
various circumstances, the thick portions 13429 can be configured to receive
at least a portion of
the staple legs 13032 of the staples 13030 therein when the staples 13030 are
in their unfired
position, as illustrated in FIG. 336. In such embodiments, the thick portions
13429 can hold the
staple legs 13032 in position such that the legs 13032 are aligned, or at
least substantially
aligned, with the staple-forming pockets of an anvil positioned opposite the
tissue thickness
compensator 13420.
[0657] In various embodiments, referring now to FIGS. 339 and 340, a staple
cartridge can
comprise a tissue thickness compensator 13720 and a skin, or top layer, 13721,
for example. In
at least one such embodiment, the tissue thickness compensator 13720 can
comprise pyramidal
and/or stepped bumps, projections, and/or protrusions 13728, for example,
which can extend
upwardly from the top surface 13721 of the tissue thickness compensator 13720.
The
projections 13728 can be configured to receive and envelop the tips of the
staple legs 13032 of
the staples 13030 when the staples 13030 are in their unfired position, as
illustrated in FIG. 340.
Similarly, the top layer 13721 can comprise pyramidal and/or stepped bumps,
projections, and/or
protrusions 13729 which can be aligned, or at least substantially aligned,
with the projections
13728. In various embodiments, the skin 13721 can further comprise one or more
teeth 13727
extending upwardly from the projections 13729 which can be configured to
engage tissue
positioned against the top layer 13721 and prevent, or at least limit,
relative lateral and/or
longitudinal movement between the tissue, the top layer 13721, and/or the tips
of the staple legs
13032. In use, the staple legs 13032 can penetrate the projections 13728 and
13729 and emerge
from the tissue thickness compensator 13720 when the staples 13030 are moved
from their
unfired positions to their fired positions. In various embodiments, referring
now to FIGS. 341
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and 342, a staple cartridge can comprise a tissue thickness compensator 13820
and a skin, or top
layer, 13821, for example. In at least one such embodiment, the tissue
thickness compensator
13820 can comprise pyramidal and/or stepped bumps, projections, and/or
protrusions 13828, for
example, which can extend upwardly from the top surface 13821 of the tissue
thickness
compensator 13820. The projections 13828 can be configured to receive and
envelop the tips of
the staple legs 13032 of the staples 13030 when the staples 13030 are in their
unfired position, as
illustrated in FIG. 342. Similarly, the top layer 13821 can comprise pyramidal
and/or stepped
bumps, projections, and/or protnisions 13829 which can be aligned, or at least
substantially
aligned, with the projections 13828. In various embodiments, the top layer
13821 can further
comprise one or more teeth 13827 extending downwardly into the tissue
thickness compensator
13820 which can be configured to prevent, or at least limit, relative lateral
and/or longitudinal
movement between the top layer 13821 and the tissue thickness compensator
13820, for
example. In use, the staple legs 10032 can penetrate the projections 13828 and
13829 and
emerge from the tissue thickness compensator 13820 when the staples 13030 are
moved from
their unfired positions and their fired positions.
[0658] In various embodiments, referring now to FIG. 343, a staple cartridge
can comprise a
tissue thickness compensator, such as tissue thickness compensator 13920, for
example, which
can include ridges 13923 and valleys 13924 defined therein wherein, in at
least one embodiment,
the valleys 13924 can be defined between the ridges 13923. In various
embodiments, each ridge
13923 can comprise the same height, substantially the same height, or
different heights.
Similarly, each valley 13924 can comprise the same depth, substantially the
same depth, or
different depths. In various embodiments, a plurality of staples 13030 can be
at least partially
stored within the tissue thickness compensator 13920 such that the tips of the
staples 13030 can
be positioned within the ridges 13923. In at least one such embodiment, the
staple legs 13032 of
the staples 13030 may not protrude from the tissue thickness compensator 13920
and/or a skin,
or top layer, 13921 attached to the tissue thickness compensator 13920, for
example, when the
staples 13030 are stored in their unfired position. In various embodiments,
the ridges 13923
and/or the valleys 13924 can extend laterally across the staple cartridge. In
at least one such
embodiment, the staple cartridge can comprise a longitudinal knife slot
wherein the ridges 13923
and the valleys 13924 can extend in a direction which is transverse and/or
perpendicular to the
knife slot. In various circumstances, the ridges 13923 can be configured to
hold the tips of the
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staple legs 13032 in position until the staples 13030 are moved from their
unfired position into
their fired position. In various embodiments, referring now to FIG. 344, a
tissue thickness
compensator, and/or a skin covering a tissue thickness compensator, can
comprise longitudinal
ridges and/or valleys. In at least one such embodiment, a tissue thickness
compensator can
comprise a top surface defined by ridges 14023 and valleys 14024, wherein the
valleys 14024
can be defined between the ridges 14023, for example. In various embodiments,
the tissue
thickness compensator can comprise a skin 14021 which can include a plurality
of apertures
14029 defined therein which can each be configured to receive a staple leg
13032. In certain
embodiments, the apertures 14029 can be defined in the ridges 14023 wherein
the tips of the
staple legs 13032 may be positioned below the peaks 14028 of the ridges 14029,
positioned flush
with the peaks 14028, and/or positioned above the peaks 14028. In certain
embodiments, in
addition to or in lieu of the above, the apertures 14029 can be defined in the
valleys 14024, for
example. In certain embodiments, each aperture can be surrounded, or at least
partially
surrounded, by an embossment, for example, which can strengthen the skin
and/or tissue
thickness compensator surrounding the apertures. In any event, further to the
above, the skin
14021 can be attached to a tissue thickness compensator in any suitable
manner, including using
at least one adhesive, for example.
[0659] As described above and referring again to FIG. 233, a surgical stapling
instrument can
comprise an anvil, such as anvil 10060, for example, which can be moved
between an open
position and a closed position in order to compress tissue T against the
tissue thickness
compensator 10020 of a staple cartridge 10000, for example. In various
circumstances, the anvil
10060 can be rotated toward the staple cartridge 10000 until its downward
movement is stopped
by some portion of the staple cartridge 10000 and/or some portion of the
channel in which the
staple cartridge 10000 is positioned. In at least one such circumstance, the
anvil 10060 can be
rotated downwardly until its downward movement is resisted by the nose 10003
of the staple
cartridge 10000 and/or the tissue T positioned intermediate the nose 10003 and
the staple
cartridge 10000. In some circumstances, the anvil 10060 may sufficiently
compress the tissue
thickness compensator 10020 to permit the tissue T to contact the tips of the
staples 10030. In
certain circumstances, depending on the thickness of the tissue T, the anvil
10060 may
sufficiently compress the tissue thickness compensator 10020 such that the
anvil 10060 comes
into contact with the staples 10030 by the time the anvil 10060 has reached
its fully closed
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position. Stated another way, in such circumstances, the anvil 10060 may
deform the staples
10030 prior to the firing member 10052 being advanced into the staple
cartridge 10000 to fire the
staples 10030. Such circumstances may be acceptable in certain embodiments;
however,
referring now to FIGS. 358 and 359, other embodiments are envisioned in which
a distal gap-
setting element, such as element 10059, for example, can be utilized to limit
the distance in
which the anvil 10060 can be closed prior to the firing bar 10052 being
advanced into the staple
cartridge 10000. In various embodiments, the element 10059 can extend upwardly
from the top
surface 10021 of the tissue thickness compensator 10020 such that the downward
movement of
the anvil 10060 can be arrested as the tissue T is compressed against the
element 10059 and a
resistive force is generated therebetween. In use, as described above, the
firing member 10052
can be advanced distally into the staple cartridge 10000 toward the distal end
10002 of the staple
cartridge 10000 in order to eject the staples 10030 from the support portion
10010.
Simultaneously, the firing member 10052 can engage the anvil 10060 and
position the anvil
10060 a desired distance from the deck surface 10011 (FIG. 218) of the support
portion 10010
over the staples 10030 being formed. In this way, the firing member 10052 can
control the
distance, or gap, between the tissue-contacting surface of the anvil 10060 and
the deck surface
10011 at a particular location, wherein this particular location can be
advanced distally as the
firing member 10052 is advanced distally. In various circumstances, this gap
distance may be
shorter than the gap between the anvil 10060 and the deck surface 10011 being
controlled or
dictated by the distal gap-setting element 10059 at the distal end of the
tissue thickness
compensator 10020. In various embodiments, referring now to FIG. 359, the
knife edge 10053
of the firing member 10052 can be configured to transect the distal gap-
setting element 10059
when the firing member 10052 reaches the distal end of the tissue thickness
compensator 10020
such that, after the element 10059 has been transected, the firing member
10052 can pull the
anvil 10060 downwardly toward the support portion 10010 and close the gap to
the desired gap
height when firing the staples 10030 at the distal end of the staple cartridge
10000. In certain
alternative embodiments, a distal gap-setting element can be configured to
collapse as the firing
member approaches the distal end of the staple cartridge. In at least one such
embodiment, the
distal gap-setting element can comprise a column which can provide resistance
to the anvil as
described above and then suddenly buckle once the buckling strength of the gap-
setting element
has been reached when the firing member approaches the distal end of the
staple cartridge. In at
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least one embodiment, this buckling force can be approximately 10 lbf, for
example. In certain
embodiments, a gap setting element can be configured to drop downwardly into
the deck of the
support portion when a force exceeding a predetermined amount is applied to
the gap setting
element, for example. In certain other embodiments, the distal gap can be
controlled by the nose
of the staple cartridge. In at least one such embodiment, the downward
movement of the anvil
10060 can be limited by the nose until the firing member has reached the
distal end of the
cartridge wherein, at such point, the compressive force applied to the nose
can cause the nose to
collapse. In certain embodiments, the nose can comprise a cavity defined by
cavity walls which
can allow the cavity to collapse once the compressive force applied thereto
has exceed a
predetermined force. In at least one such embodiment, the cavity can be
defined by collapsible
walls.
[0660] In various embodiments, as described above, an anvil, such as anvil
10060, for
example, can be moved between an open position and a closed position in order
to compress a
tissue thickness compensator between the anvil and the support portion of a
staple cartridge. In
certain circumstances, referring now to FIGS. 360 and 361, the tissue
thickness compensator of a
staple cartridge, such as tissue thickness compensator 14120 of staple
cartridge 14100, for
example, may expand laterally and/or longitudinally when the tissue thickness
compensator
14120 is compressed against a support portion 14110 of the staple cartridge
14100. In certain
embodiments, the ends and/or sides of the tissue thickness compensator 14120
may not be
constrained by the support portion 14110 and/or the anvil 10060 and, as a
result, the tissue
thickness compensator 14120 can expand in those directions without generating
a compressive
pressure, or at least an undesirable compressive pressure, within the tissue
thickness compensator
14120. In such embodiments, a firing member, such as firing member 10052 (FIG.
236), for
example, passing through the tissue thickness compensator 14120 may not be
unduly impeded by
an undesirable compressive pressure within the tissue thickness compensator
14120, for
example. In certain other embodiments, referring again to FIG. 360, the distal
end 14125 of the
tissue thickness compensator 14120 may be constrained by the nose 14103 of the
staple cartridge
14100, for example. In this particular embodiment, similar to the above, the
distal end 14125 of
the tissue thickness compensator 14120 may be constrained by the nose 14103 in
order to reduce
the possibility of the tissue thickness compensator 14120 from becoming
prematurely detached
from the support portion 14110. In any event, as a result of the above, a
large internal pressure
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can be generated within the distal end 14125 which can impede the advancement
of the firing
member 10052, especially when the firing member 10052 reaches the distal end
14125. More
particularly, in certain circumstances, the firing member 10052 can push,
plow, and/or displace
the tissue thickness compensator 14120 distally as it transects the tissue
thickness compensator
14120 and, as a result, an even larger internal pressure can be created within
the distal end 14125
of the tissue thickness compensator 14120. In order to at least partially
dissipate this pressure
within the tissue thickness compensator 14120, the nose 14103 can be comprised
of a flexible
material which can allow the nose 14103 to flex distally, for example, and
create additional
space for the tissue thickness compensator 14120. In certain embodiments,
referring now to
FIGS. 362 and 363, the nose of a staple cartridge can comprise a portion which
can slide distally.
More particularly, the nose 14203 of the staple cartridge 14200 can comprise a
slidable portion
14204 which can be slidably connected to the nose 14203 such that, when the
anvil 10060 is
closed and/or the firing member 10052 is advanced into the distal end of the
staple cartridge
14200, the slidable portion 14204 can slide distally and create additional
room for the tissue
thickness compensator 14200 and at least partially alleviate the internal
pressure therein. In at
least one embodiment, one of the nose 14203 and the slidable portion 14204 can
comprise one or
more rails and the other of the nose 14203 and the slidable portion 14204 can
comprise one or
more channels configured to slidably receive the rails therein. In at least
one such embodiment,
the channels and rails can be configured to co-operatively limit the movement
of the slidable
portion 14204 to a longitudinal distal path, for example.
[0661] In various circumstances, further to the above, certain staples, such
as the distal-most
staples within a staple cartridge, for example, can capture a larger portion
of a tissue thickness
compensator than the proximal staples within the staple cartridge. In such
circumstances, as a
result, a large clamping pressure can be applied to the tissue captured within
the distal staples as
compared to the proximal staples. These circumstances can arise when at least
a portion of the
tissue thickness compensator is shifted to and/or gathered at the distal end
of the staple cartridge
during use, as described above, eventhough the tissue thickness compensator
may be comprised
of a substantially homogenous material having a substantially constant
thickness. In various
circumstances, it may be desirable for certain staples to apply a higher
clamping pressure to the
tissue than other staples wherein, in various embodiments, a support portion
and/or a tissue
thickness compensator can be constructed and arranged to control which staples
may apply the
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higher clamping pressure to the tissue and which staples may apply a lower
clamping pressure to
the tissue. Referring now to FIG. 364, a staple cartridge 14300 can comprise a
support portion
14310 and, in addition, a tissue thickness compensator 14320 positioned on the
deck surface
14311 of the support portion 14310. As compared to other embodiments disclosed
in this
application which comprise a support portion 14310 having a flat, or at least
substantially flat,
deck surface, the deck surface 14311 can be inclined and/or declined between
the distal end
14305 and the proximal end 14306 of the support portion 14310. In at least one
embodiment, the
deck surface 14311 of the support portion 14310 can comprise a deck height at
its distal end
14305 which is shorter than the deck height at its proximal end 14306. In at
least one such
embodiment, the staples 10030 at the distal end of the staple cartridge 14300
can extend above
the deck surface 14311 a larger distance than the staples 10030 at the
proximal end. In various
alterative embodiments, the deck surface of a support portion can comprise a
height at its distal
end which is taller than its height at its proximal end. Referring again to
FIG. 364, the tissue
thickness compensator 14320 may comprise a thickness which is different along
the longitudinal
length thereof. In various embodiments, the tissue thickness compensator 14320
can comprise a
thickness at its distal end 14325 which is thicker than its proximal end
14326, for example. In at
least one such embodiment, the tissue thickness compensator 14322 can comprise
a bottom
surface 14322 which can be inclined or declined to match, or at least
substantially match, the
inclined or declined deck surface 14311 of the support portion 14310. As a
result, the top, or
tissue-contacting, surface 14321 of the tissue thickness compensator 14320 can
comprise a flat,
or at least substantially flat, surface upon which the tissue T can be
positioned. In any event, as
the tissue thickness compensator 14320 is thicker at its distal end 14325, the
distal staples 10030
can capture a larger portion of the tissue thickness compensator 14320 therein
than the proximal
staples 10030 and, as a result, the distal staples 10030 can apply a larger
compressive force to the
tissue T, especially when the gap distance between the anvil 10060 and the
deck surface 14311 is
constant, or at least substantially constant, at the proximal and distal ends
of the staple cartridge.
In certain circumstances, however, the anvil 10060 may not reach a fully
closed position and, as
a result, the gap distance between the anvil 10060 and the deck surface 14311
may be larger at
the distal end of the staple cartridge 14300 than the proximal end. In various
circumstances, the
distal staples 10030 may not be fully formed and, as a result, the distal
staples 10030 may not
apply the desired clamping pressure to the tissue T. In the embodiments where
the tissue
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thickness compensator is thicker at the distal end of the staple cartridge,
the tissue thickness
compensator may compensate for the underforming of the staples and apply a
sufficient pressure
to the tissue T.
[0662] In various embodiments, referring now to FIG. 365, a staple cartridge,
such as staple
cartridge 14400, for example, can comprise a support portion 14410 and, in
addition, a tissue
thickness compensator 14420 positioned on the deck surface 14411 of the
support portion 14410.
Similar to the above, the deck surface 14411 can be inclined and/or declined
such that, in at least
one embodiment, the distal end 14405 of the support portion 14410 can have a
deck height
which is shorter than the deck height at the proximal end 14406, for example.
In certain
embodiments, the tissue thickness compensator 14420 can comprise a constant,
or at least
substantially constant, thickness along the length thereof and, as a result,
the top, or tissue-
contacting, surface 14421 of the tissue thickness compensator 14420 may
parallel, or at least
substantially parallel, the contour of the deck surface 14411. In various
embodiments, the
staples 10030 of the staple cartridge 14400 can be completely embedded within
the tissue
thickness compensator 14420 and the support portion 14410 when the staples
10030 are in their
unfired position. In certain embodiments, the staples 10030 positioned at the
proximal end of the
staple cartridge 14400 may be completely embedded within the tissue thickness
compensator
14420 and the support portion 14410 when the staples 10030 arc in their
unfired position
whereas, due to the declined slope of the deck 14411 and top surface 14421,
the tips of certain
staples 10030, including the staples 10030 positioned at the distal end of the
staple cartridge
14400, can protrude through the top surface 14421 of the tissue thickness
compensator 14420
when the staples 10030 are in their unfired position.
[0663] In various embodiments, as described above, a tissue thickness
compensator can be
comprised of a single material wherein the entirety of the tissue thickness
compensator can have
the same, or at least substantially the same, material properties, such as
density, stiffness, spring
rate, durometer, and/or elasticity, for example, throughout. In various other
embodiments,
referring now to FIG. 368, a tissue thickness compensator, such as tissue
thickness compensator
14520, for example, can comprise a plurality of materials or layers of
materials. In at least one
embodiment, the tissue thickness compensator 14520 can comprise a first, or
central, layer
14520a, second, or intermediate, layers 14520b attached to the first layer
14520a on opposite
sides thereof, and a third, or outer layer 14520c attached to each of the
second layers 14520b. In
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certain embodiments, the intermediate layers 14520b can be attached to the
central layer 14520a
utilizing at least one adhesive and, similarly, the outer layers 14520c can be
attached the second
layers 14520 utilizing at least one adhesive. In addition to or in lieu of an
adhesive, the layers
14520a-14520c can be held together by one or more interlocking features and/or
fasteners, for
example. In any event, the inner layer 14520a can be comprised of a first
material having a first
set of material properties, the intermediate layers 14520b can be comprised of
a second material
having a second set of material properties, and the outer layers 14520c can be
comprised of a
third material having a third set of material properties, for example. These
sets of material
properties can include density, stiffness, spring rate, durometer, and/or
elasticity, for example. In
certain embodiments, a staple cartridge can comprise six rows of staples
10030, for example,
wherein a row of staples 10030 can be at least partially positioned in each of
the outer layers
14520c and each of the inner layers 14520b, for example, and wherein two rows
of staples 10030
can be at least partially positioned with the inner layer 14520a. In use,
similar to the above, the
staples 10030 can be ejected from the staple cartridge such that the staple
legs 10032 of the
staples 10030 penetrate the top surface 14521 of the tissue thickness
compensator 14520,
penetrate tissue positioned against the top surface 14521 by an anvil, and
then contact the anvil
such that the legs 10032 are deformed to capture the tissue thickness
compensator 14520 and the
tissue within the staples 10030. Also similar to the above, the tissue
thickness compensator
14520 can be transected by a firing member as the firing member is advanced
through the staple
cartridge. In at least one such embodiment, the firing member can transect the
inner layer
14520a, and the tissue, along a path defined by axis 14529, for example.
[0664] In various embodiments, further to the above, the rows of staples 10030
positioned
within the inner layer 14520a can comprise the staple rows which are closest
to the edges of the
transected tissue. Correspondingly, the rows of staples 10030 positioned
within the outer layers
14520c can comprise the staple rows which are furthest away from the edges of
the transected
tissue. In certain embodiments, the first material comprising the inner layer
14520a may
comprise a density which is higher than the density of the second material
comprising the
intermediate layers 14520b and, similarly, the density of the second material
may be higher than
the density of the third material comprising the outer layers 14520c, for
example. In various
circumstances, as a result, larger compressive forces can be created within
the staples 10030
positioned within the inner layer 14520a as compared to the compressive forces
generated within
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the staples 10030 positioned within the intermediate layers 14520b and the
outer layers 14520c.
Similarly, larger compressive forces can be created within the staples 10030
positioned within
the intermediate layers 14520b as compared to compressive forces created
within the staples
10030 positioned within the outer layers 14520c, for example. In various
alternative
embodiments, the first material comprising the inner layer 14520a may comprise
a density which
is lower than the density of the second material comprising the intermediate
layers 14520b and,
similarly, the density of the second material may be lower than the density of
the third material
comprising the outer layers 14520c, for example. In various circumstances, as
a result, larger
compressive forces can be created within the staples 10030 positioned within
the outer layers
14520c as compared to the compressive forces created within the staples 10030
positioned
within the intermediate layers 14520b and the inner layer 14520a. Similarly,
larger compressive
forces can be created within the staples 10030 positioned within the
intermediate layers 14520b
as compared to the compressive forces created within the staples 10030
positioned within the
inner layer 14520a, for example. In various other embodiments, any other
suitable arrangement
of layers, materials, and/or material properties could be utilized. In any
event, in various
embodiments, the layers 14520a-14520c of the tissue thickness compensator
14520 can be
configured to remain attached to one another after they have been implanted.
In certain other
embodiments, the layers 14520a-14520c of the tissue thickness compensator
14520 can be
configured to detach from one another after they have been implanted. In at
least one such
embodiment, the layers 14520a-14520c can be bonded together utilizing one or
more
bioabsorbable adhesives which can initially hold the layers together and then
allow the layers to
release from one another over time.
[0665] As described above, a tissue thickness compensator of a staple
cartridge, such as tissue
thickness compensator 14520, for example, can comprise a plurality of
longitudinal layers. In
various other embodiments, referring now to FIG. 369, a staple cartridge can
comprise a tissue
thickness compensator, such as tissue thickness compensator 14620, for
example, which can
comprise a plurality of horizontal layers. In at least one such embodiment,
the tissue thickness
compensator 14620 can comprise a first, or bottom, layer 14620a, a second, or
intermediate,
layer 14620b attached to the bottom layer 14620a, and a third, or top, layer
14620c attached to
the intermediate layer 14620b. In various embodiments, the first layer 14620a
can comprise a
flat, or substantially flat, bottom surface 14626a and a triangular, or
pyramidal, top surface
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14625a, for example. In at least one such embodiment, the second layer 14620b
can comprise a
triangular, or pyramidal, bottom surface 14626b which can be configured to
parallel and abut the
top surface 14625a of the first layer 14620a. Similar to the above, the second
layer 14620b can
comprise a triangular, or pyramidal, top surface 14625b which can parallel and
abut a bottom
triangular, or pyramidal, bottom surface 14626c of the third layer 14620c, for
example. In
various embodiments, the top surface of the third layer 14626c can comprise a
flat, or at least
substantially flat, tissue-contacting surface 14621. Also similar to the
above, the tissue thickness
compensator 14620 can be configured to at least partially store six rows of
staples, such as
staples 10030, for example, therein wherein a firing member can transeet the
tissue thickness
compensator 14620 between the two innermost staple rows along a path extending
through axis
14629, for example. Similar to the above, each layer 14620a, 14620b, and
14620c can be
comprised of a different material which can comprise different material
properties and, as a
result of the triangular, or pyramidal, configuration of the layers 14620a-
14620c, the tissue
thickness compensator 14620 can have different overall properties at various
locations
therewithin. For example, the outermost rows of staples 10030 may capture more
of the third
layer 14620c than the first layer 14620a therein whereas the innermost rows of
staples 10030
may capture less of the third layer 14620c than the first layer 14620a and, as
a result, the tissue
thickness compensator 14620 may compress the tissue captured within the
outermost staples
10030 differently than the tissue captured within the innermost staples 10030,
for example,
eventhough the tissue thickness compensator 14620 may have the same, or at
least substantially
the same, overall thickness thereacross.
[0666] In various embodiments, referring now to FIG. 286, a tissue thickness
compensator of a
staple cartridge, such as tissue thickness compensator 14720 of staple
cartridge 14700, for
example, can comprise voids, pockets, channels, and/or grooves, for example,
defined therein
which can vary the thickness of the tissue thickness compensator 14720. In at
least one such
embodiment, the tissue thickness compensator 14720 can be positioned against
the deck surface
14711 of a support portion 14710 of the staple cartridge 14700 such that voids
14723 defined in
the bottom surface 14722 of the tissue thickness compensator 14720 can overlie
certain staple
cavities 10012, but not others. In various embodiments, the voids 14723 can
extend transversely
to the knife slot 14715 of the support portion 14710, perpendicular to the
knife slot 14715, and/or
parallel to the knife slot 14715, for example. In certain embodiments, the
voids 14723 can
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define a tread pattern in the bottom surface 14722 of the tissue thickness
compensator 14720. In
any event, when staples, such as staples 10030, for example, are deployed from
the support
portion 14710, referring now to FIGS. 287 and 288, certain staples 10030 can
capture the tissue
thickness compensator 14720 within a region containing a void 14723 while
other staples 10030
can capture the tissue thickness compensator 14720 within a region positioned
intermediate the
voids 14723. In addition to or in lieu of the above, the tissue thickness
compensator 14720 can
comprise voids, pockets, channels, and/or grooves, for example, defined in the
top, or tissue-
contacting, surface 14721. In certain embodiments, referring now to FIGS. 366
and 367, a staple
cartridge 14800 can comprise a tissue thickness compensator 14820 which can
include a
plurality of treads 14823 extending at least one of upwardly from a top
surface 14821 of the
tissue thickness compensator 14820, inwardly toward a central groove 14825,
and/or distally
toward the distal end of the staple cartridge 14800, for example. In at least
one such
embodiment, the treads 14823 can be separated by channels, slots, and/or
grooves, such as
channels 14824, for example. In various circumstances, as a result of the
above, the overall
thickness of the tissue thickness compensator can vary between staple rows
and/or vary between
the staples within a staple row. In certain circumstances, the treads, or
thick portions, can be
constructed and arranged such that they can flow in a desire direction, such
as inwardly, for
example, when the tissue thickness compensator is compressed.
[0667] In various embodiments, referring now to FIG. 303, a staple cartridge,
such as staple
cartridge 14900, for example, can comprise a support portion 14910 and, in
addition, a tissue
thickness compensator 14920 positioned against the support portion 14910.
Similar to the
above, the support portion 14910 can comprise staple drivers which can be
lifted upwardly by a
staple-deploying sled in order to lift staples, such as staples 10030, for
example, at least partially
positioned within the support portion 14910 toward an anvil, such as anvil
10060, for example,
positioned opposite the staple cartridge 14900. In certain embodiments, the
support portion
14910 can comprise six rows of staple cavities, such as two outer rows of
staple cavities, two
inner rows of staple cavities, and two intermediate rows of staple cavities
positioned intermediate
the inner rows and the outer rows, for example, wherein the anvil 10060 can
comprise six rows
of forming pockets 10062 aligned, or at least substantially aligned, with the
staple cavities. In
various embodiments, the inner rows of staple cavities can include staple
drivers 14940a
positioned therein, the intermediate rows of staple cavities can include
staple drivers 14940b
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positioned therein, and the outer rows of staple cavities can include staple
drivers 14940c
positioned therein, wherein each of the staple drivers 14940a can include a
cradle 14949a
configured to support a staple 10030, wherein each of the staple drivers
14940b can include a
cradle 14949b configured to support a staple 10030, and wherein each of the
staple drivers
14940c can include a cradle 14949c configured to support a staple 10030. In
their unfired
positions, i.e., when the staple drivers 14940a-14940c are sitting on driver
supports 14926 which
extend underneath the support portion 14910, the cradles 14949a of the staple
drivers 14940a can
be positioned closer to the anvil 10060 than the cradles 14949b of the staple
drivers 14940b and
the cradles 14949c of the staple drivers 14940c. In such a position, a first
forming distance can
be defined between the cradles 14949a and the forming pockets 10062 positioned
over the
cradles 14949a, a second forming distance can be defined between the cradles
14949b and the
forming pockets 10062 positioned over the cradles 14949b, and a third forming
distance can be
defined between the cradles 14949c and the forming pockets 10062 positioned
over the cradles
14949c, wherein, in various embodiments, the first forming distance can be
shorter than the
second forming distance and the second forming distance can be shorter than
the third forming
distance, for example. When the staple drivers 14940a-14940c are moved from
their unfired
positions (FIG. 303) to their fired positions, each staple driver 14940a-
14940c can be moved
upwardly an equal, or an at least substantially equal, distance toward the
anvil 10060 by the
staple-deploying sled such that the first drivers 14940a drive their
respective staples 10030 to a
first formed height, the second drivers 14940b drive their respective staples
10030 to a second
formed height, and the third drivers 14940c drive their respective staples
10030 to a third formed
height, wherein the first formed height can be shorter than the second formed
height and the
second formed height can be shorter than the third formed height, for example.
Various other
embodiments are envisioned in which the first staple drivers 14940a are
displaced upwardly a
first distance, the second staple drivers 14940b are displaced upwardly a
second distance, and the
third staple drivers 14940c are displaced upwardly a third distance, wherein
one or more of the
first distance, the second distance, and the third distance can be different.
[0668] In various embodiments, referring again to FIG. 303, the deck surface
14911 of the
support portion 14910 can vary in height with respect to the tissue-contacting
surface 10061 of
the anvil 10060. In certain embodiments, this height variation can occur
laterally and, in at least
one embodiment, the height of the deck surface 14911 surrounding the inner
rows of staple
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cavities can be higher than the deck surface 14911 surrounding the outer rows
of staple cavities,
for example. In various embodiments, the bottom surface 14922 of the tissue
thickness
compensator 14920 can be configured to parallel, or at least substantially
parallel, the deck
surface 14911 of the support portion 14910. Further to the above, the tissue
thickness
compensator 14920 can also vary in thickness wherein, in at least one
embodiment, the top, or
tissue-contacting, surface 14921 of the tissue thickness compensator 14920 can
slope inwardly
from the outside or lateral edges thereof. In at least one such embodiment, as
a result of the
above, the tissue thickness compensator 14920 can be thinner in a region
positioned over the
inner rows of staple cavities and thicker in a region positioned over the
outer rows of staple
cavities, for example. In various embodiments, referring now to FIG. 304, the
deck surface of a
support portion 15010 can comprise a stepped deck surface, for example,
wherein the highest
steps of the stepped surface can surround the inner rows of staple cavities
and the lowest steps of
the stepped surface can surround the outer rows of staple cavities, for
example. In at least one
such embodiment, steps having an intermediate height can surround the
intermediate rows of
staple cavities. In certain embodiments, a tissue thickness compensator, such
as tissue thickness
compensator 15020, for example, can comprise a bottom surface which can
parallel and abut the
deck surface of the support portion 15010. In at least one embodiment, the
top, or tissue-
contacting, surface 15021 of the tissue thickness compensator can comprise an
arcuate,
parabolic, and/or curved surface, for example, which, in at least one such
embodiment, can
extend from a first lateral side of the tissue thickness compensator 15020 to
a second lateral side
of the tissue thickness compensator 15020 with an apex aligned, or at least
substantially aligned,
with the center of the staple cartridge 15000, for example. In various
embodiments, referring
now to FIG. 299, a staple cartridge 15300, for example, can comprise a support
portion 15310, a
plurality of staple drivers 15340 movably positioned within staple cavities
defined in the support
portion 15310, and a tissue thickness compensator 15320 positioned above the
deck surface
15311 of the support portion 15310. The staple cartridge 15300 can further
comprise one or
more bottom pan portions 15326 which can be attached to the support portion
15310 and extend
around the bottom of the support portion 15310 and support the drivers 15340,
and staples
15330, in their unfired positions. As a staple-deploying sled is advanced
through the staple
cartridge, the sled can also be supported by the bottom pan portions 15326 as
the sled lifts the
staple drivers 15340 and the staples 15330 upwardly through the tissue
thickness compensator
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15320. In at least one embodiment, the tissue thickness compensator 15320 can
comprise a first,
or inner, portion 15322a positioned over an inner row of staple cavities, a
second, or intermediate
portion 15322b positioned over an intermediate row of staple cavities, and a
third, or outer,
portion 15322c positioned over a row of staple cavities, wherein the inner
portion 15322a can be
thicker than the intermediate portion 15322b and the intermediate portion
15322b can be thicker
than the outer portion 15322c, for example. In at least one embodiment, the
tissue thickness
compensator 15320 can comprise longitudinal channels, for example, defined
therein which can
create the thinner portions 15322b and 15322c of the tissue thickness
compensator 15320. In
various alternative embodiments, the longitudinal channels can be defined in
the top surface
and/or the bottom surface of a tissue thickness compensator. In at least one
embodiment, the top
surface 15321 of the tissue thickness compensator 15320 can comprise a flat,
or at least
substantially flat, surface, for example.
[0669] In various embodiments, referring now to FIG. 296, a staple cartridge
can comprise a
tissue thickness compensator, such as tissue thickness compensator 15120, for
example, which
can comprise a plurality of portions having different thicknesses. In at least
one embodiment,
the tissue thickness compensator 15120 can comprise a first, or inner, portion
15122a which can
have a first thickness, second, or intermediate, portions 15122b extending
from the first portion
15122b which can each have a second thickness, and third, or outer, portions
15122e extending
from the second portions 15122b which can each have a third thickness. In at
least one such
embodiment, the third thickness can be thicker than the second thickness and
the second
thickness can be thicker than the first thickness, for example, although any
suitable thicknesses
could be utilized in various other embodiments. In various embodiments, the
portions 15122a-
15122c of the tissue thickness compensator 15120 can comprise steps having
different thickness.
In at least one embodiment, similar to the above, a staple cartridge can
comprise several rows of
staples 10030 and a plurality of staple drivers having different heights which
can deform the
staples 10030 to different formed heights. Also similar to the above, the
staple cartridge can
comprise first staple drivers 15140a which can drive the staples 10030
supported thereon to a
first formed height, second staple drivers 15140b which can drive the staples
10030 supported
thereon to a second formed height, and third staple drivers which can drive
the staples 10030
supported thereon to a third formed height, wherein the first formed height
can be shorter than
the second formed height and the second formed height can be shorter than the
third formed
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height, for example. In various embodiments, as illustrated in FIG. 296, each
staple 10030 can
comprise the same, or substantially the same, unformed, or unfired, height. In
certain other
embodiments, referring now to FIG. 296A, the first drivers 15140a, the second
drivers 15140b,
and/or the third drivers 15140c can support staples having different unformed
heights. In at least
one such embodiment, the first staple drivers 15140a can support staples
15130a having a first
unformed height, the second staple drivers 15140b can support staples 15130b
having a second
unformed height, and the third staple drivers 15140c can support staples
15130c having a third
unformed height, wherein the first unformed height can be shorter than the
second unformed
height and the second unformed height can be shorter than the third unformed
height, for
example. In various embodiments, referring again to FIG. 296A, the tips of the
staples 15130a,
15130b, and/or 15130c can lie, or at least substantially lie, in the same
plane while, in other
embodiments, the tips of the staples 15130a, 15130b, and/or 15130c may not lie
in same plane.
In certain embodiments, referring now to FIG. 297, a staple cartridge can
include a tissue
thickness compensator 15220 having a plurality of portions having different
thickness which can
be implanted against the tissue T by the staples 15130a, 15130b, and 15130c,
as described above.
In at least one embodiment, referring now to FIG. 298, the staples 15130a,
15130b, and/or
15130e can be deformed to different formed heights wherein the first staples
15130a can be
formed to a first formed height, the second staples 15130b can be formed to a
second formed
height, and the third staples 15130c can be formed to a third formed height,
and wherein the first
formed height can be shorter than the second formed height and the second
formed height can be
shorter than the third formed height, for example. Other embodiments are
envisioned in which
the staples 15130a, 15130b, and 15130c can be formed to any suitable formed
heights and/or any
relative formed heights.
[0670] In various embodiments, as described above, the anvil of a surgical
stapling instrument
can be moved between an open position and a closed position. In such
circumstances, the tissue-
contacting surface of the anvil can be moved into its final, or forming,
position as the anvil is
moved into its closed position. Once the anvil is in its closed position, in
certain embodiments,
the tissue-contacting surface may no longer be adjustable. In certain other
embodiments,
referring now to FIG. 351, a surgical stapler, such as surgical stapler 15500,
for example, can
comprise an anvil channel 15560 and an adjustable tissue-contacting anvil
adjustment plate
15561 positioned within the anvil channel 15560. In such embodiments, the
anvil plate 15561
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can be raised and/or lowered within the anvil channel 15560 in order to adjust
the position of the
tissue-contacting surface of the anvil plate 15561 relative to a staple
cartridge positioned
opposite the anvil plate 15561. In various embodiments, the surgical stapler
15500 can comprise
an adjustment slide 15564 which, referring to FIGS. 356 and 357, can be slid
intermediate the
anvil channel 15560 and the anvil plate 15561 in order to control the distance
between the anvil
plate 15561 and the staple cartridge. In certain embodiments, referring again
to FIGS. 351 and
352, the surgical stapler 15500 can further comprise an actuator 15562 coupled
to the adjustment
slide 15564 which can be slid proximally in order to slide the adjustment
slide 15564 proximally
and/or slid distally in order to slide the adjustment slide 15564 distally. In
various embodiments,
referring again to FIGS. 356 and 357, the actuator 15562 can be slid between
two or more pre-
defined positions in order to adjust the anvil plate 15561 between two or more
positions,
respectively. In at least one embodiment, such pre-defined positions can be
demarcated on the
surgical stapler 15500 as demarcations 15563 (FIG. 351), for example. In
certain embodiments,
referring to FIG. 357, the adjustment slide 15564 can comprise a plurality of
support surfaces,
such as first support surface 15565a, second support surface 15565b, and third
support surface
15565c, for example, which can be aligned with a plurality of plate
positioning surfaces, such as
first positioning surface 15569a, second positioning surface 15569b, and third
positioning
surface 15569c, respectively, on the backside of the anvil plate 15561 in
order to position the
anvil plate 15561 in a first position. In order to position the anvil plate
15561 in a second
position, the actuator 15562 and the slide 15564 can be slid proximally, for
example, in order to
realign the support surfaces 15565a-15565c of the slide 15564 relative to the
positioning surfaces
15569a-15569c of the anvil plate 15561. More particularly, referring to FIG.
356, the slide
15564 can be slid distally such that the first support surface 15565a of the
slide 15564 can be
positioned behind the second positioning surface 15569b of the anvil plate
15561 and such that
the second support surface 15565b of the slide 15564 can be positioned behind
the third
positioning surface 15569c of the anvil plate 15561 in order to move the anvil
plate 15561 closer
to the staple cartridge. When the anvil plate 15561 is moved from its first
position to its second
position, in such circumstances, the adjustable anvil plate 15561 can further
compress the tissue
T positioned between the anvil plate 15561 and the staple cartridge. In
addition to the above, the
formed height of the staples can be controlled by the position of the anvil
plate 15561 relative to
the staple cartridge as the forming pockets defined in the anvil plate 15561
will move closer to
233
and/or further away from the staple cartridge when the anvil plate 15561 is
adjusted. Although
only two positions are discussed above, the slide 15564 can be slid into a
suitable number of
positions to move the anvil plate 15561 closer to and/or away from the staple
cartridge. In any
event, once the anvil plate 15561 has been suitably positioned, a staple-
deploying sled 15550 can
be slid distally within the staple cartridge in order to lift staple drivers
15540 and staples 15530
toward the anvil plate 15561 and staple the tissue T, as illustrated in FIG.
354. Similar surgical
staplers are disclosed in U.S Patent Application Serial No. 13/036,647, now
U.S. Patent No.
8,561,870, entitled SURGICAL STAPLING INSTRUMENT, which was filed on February
28,
2011.
10671] In various embodiments, referring now to FIG. 353, a staple cartridge
can be positioned
within a staple cartridge channel 15570 of the surgical stapler 15500 which
can comprise a tissue
thickness compensator, such as tissue thickness compensator 15520, for
example. When the
anvil plate 15561 is moved toward the staple cartridge, as described above,
the anvil plate 15561
can compress the tissue thickness compensator 15520 and/or the tissue T
positioned intermediate
the anvil plate 15561 and the tissue thickness compensator 15520. As the
staples 15530 are
deployed from the staple cartridge, referring to FIG. 355, the staples 15530
can compress and
implant the tissue thickness compensator 15520 against the tissue T. In
various embodiments,
when the anvil plate 15561 is positioned against the slide 15564 and tissue
has not yet been
placed between the anvil plate 15561 and the tissue thickness compensator
15520, a gap can be
defined between the anvil plate 15561 and the top surface 15521 of the tissue
thickness
compensator 15520 when the anvil plate 15561 is in a first position. When the
anvil plate 15561
is moved into a second position, the anvil plate 15561 can contact the tissue
thickness
compensator 15520. In various alternative embodiments, when the anvil plate
15561 is
positioned against the slide 15564 and tissue has not yet been placed between
the anvil plate
15561 and the tissue thickness compensator 15520, a gap can be defined between
the anvil plate
15561 and the top surface 15521 of the tissue thickness compensator 15520 when
the anvil plate
15561 is in a first position and/or a second position. In at least one such
embodiment, the anvil
plate 15561 may not come into contact with the tissue thickness compensator
15520. In further
alternative embodiments, when the anvil plate 15561 is positioned against the
slide 15564 and
tissue has not yet been placed between the anvil plate 15561 and the tissue
thickness
compensator 15520, the anvil plate 15561 can be in contact with the top
surface 15521 of the
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tissue thickness compensator 15520 regardless of whether the anvil plate 15561
is in a first
position and/or a second position, for example. Although only two positions
for the anvil plate
15611 are described herein, the anvil plate 15611 may be positioned, or
indexed, into any
suitable number of positions.
[0672] In various embodiments, as a result of the above, a surgical stapling
instrument can
comprise means for adjusting the formed height of the staples which can, in
various
circumstance, compensate for different tissue thicknesses. In addition, the
surgical stapling
instrument can comprise other means for compensating for different tissue
thicknesses and/or
thickness variations within the tissue, for example. In at least one such
embodiment, the anvil
plate 15561 can be adjusted upwardly, or away, from the opposing staple
cartridge to increase
the formed, or fired, height of the staples. Correspondingly, the anvil plate
15561 can be
adjusted downwardly, or toward, the opposing staple cartridge to decrease the
formed, or fired,
height of the staples. In various embodiments, the adjustment of the anvil
plate 15561, for
example, can adjust the gap between the forming pockets defined in the anvil
plate 15561 and
the fired height of the staple drivers or, more specifically, the fired height
of the staple driver
cradles, for example. Even with such a capacity to adjust the formed height of
the staples to
account for thicker and/or thinner tissue, for example, a tissue thickness
compensator can also
compensate for thicker and/or thinner tissue and/or compensate for thickness
variations within
the tissue, as described above. In such embodiments, a surgeon can be afforded
with several
compensation means within the same surgical stapling instrument.
[0673] As described above and illustrated in several embodiments, a surgical
stapling
instrument can utilize a staple cartridge having a linear arrangement of
staple cavities and staples
wherein a firing member can be advanced distally through the staple cartridge
to deploy the
staples from the staple cavities. In certain embodiments, a staple cartridge
can comprise rows of
staple cavities and staples which are curved. In at least one embodiment,
referring now to FIGS.
345 and 346, a surgical stapling instrument, such as stapler 15600, for
example, can comprise
one or more circular or annular rows of staple cavities defined in a circular
or annular support
portion 15610. Such circular staple rows can comprise a circular row of inner
staple cavities
15612 and a circular row of outer staple cavities 15613, for example. In at
least one such
embodiment, the circular rows of staple cavities can surround a circular or
annular aperture
15615 defined in the stapler 15600 which can house a circular or annular knife
movably
235
positioned therein. In use, tissue can be positioned against the deck surface
15611 of the support
portion 15610 and an anvil (not illustrated) can be assembled to the surgical
stapler 15600 via an
actuator extending through and/or positioned within the aperture 15615 such
that, when the
actuator is actuated, the anvil can be clamped toward the support portion
15610 and compress the
tissue against the deck surface 15611. Once the tissue has been sufficiently
compressed, the
staples positioned within the staple cavities 15612 and 15613 can be ejected
from the support
portion 15610 and through the tissue such that the staples can contact the
anvil and be
sufficiently deformed to capture the tissue therein. As the staples are being
fired and/or after the
staples have been fired, the circular knife can be advanced to transect the
tissue. Thereafter, the
anvil can be moved away from the support portion 15610 and/or detached from
the surgical
stapler 15600 such that the anvil and the surgical stapler 15600 can be
removed from the surgical
site. Such surgical staplers 15600 and such surgical techniques, in various
embodiments, can be
utilized to join two portions of a large intestine, for example. In various
circumstances, the
circular staple lines may be configured to hold the portions of the large
intestine together while
the tissue heals and, at the same time, permit the portions of the large
intestine to resiliently
expand. Similar surgical stapling instruments and surgical techniques are
disclosed in U.S.
Patent No. 5,285,945, entitled SURGICAL ANASTOMOSIS STAPLING INSTRUMENT,
which issued on February 15, 1994.
[0674] In various embodiments, further to the above, a tissue thickness
compensator may be
positioned against and/or attached to the support portion 15610 of the
surgical stapler 15600, for
example. In at least one embodiment, the tissue thickness compensator can be
comprised of a
circular or annular ring of material comprising an inner radius and an outer
radius, for example.
In certain circumstances, tissue can be positioned against this ring of
material and, when the
anvil is used to move the tissue toward the support portion 15610, the tissue
thickness
compensator can be compressed between the tissue and the deck surface 15611.
During use, the
staples can be fired through the tissue thickness compensator and the tissue
such that the staples
can contact the anvil and deform to their fired position to capture portions
of the tissue and the
tissue thickness compensator within the staples. In various circumstances,
further to the above,
the ring of material comprising the tissue thickness compensator must be
sufficiently resilient to
permit the portions of the large intestine surrounding the staple lines to
expand. In various
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embodiments, referring again to FIGS. 345 and 346, a flexible tissue thickness
compensator
15620 can comprise a circular or annular flexible inner ring 15624, for
example, which, in at
least one embodiment, can define a circular or annular aperture 15625. in
certain embodiments,
the inner ring 15624 may be configured such that it is not captured within
staples deployed from
the surgical stapler 15600; rather, in at least one embodiment, the inner ring
15624 may be
positioned radially inwardly with respect to the inner row of staple cavities
15612. In at least
one such embodiment, the tissue thickness compensator 15620 can comprise a
plurality of tags,
such as inner tags 15622 and outer tags 15623, for example, extending
therefrom such that the
tags can be at least partially captured within the staples as they are being
deformed. More
particularly, referring primarily to FIG. 345, each inner tag 15622 can
comprise a head which is
positioned over a staple cavity 15612 defined in the surgical stapler 15600
wherein the head can
be attached to the inner ring 15624 by a neck 15626, for example, and,
similarly, each outer tag
15623 can comprise a head which is positioned over a staple cavity 15613
defined in the surgical
stapler 15600 wherein the head can be attached to the inner ring 15624 by a
neck 15627, for
example. In various embodiments, the heads of the inner tags 15622 and the
outer tags 15623
can comprise any suitable shape, such as round, oval, and/or elliptical, for
example. The necks
15626 and/or 15627 can also comprise any suitable shape wherein, in at least
one embodiment,
the necks 15627 connecting the heads of the outer tags 15623 to the inner ring
15624 can be
configured to extend between adjacent inner staple cavities 15612 in the
support portion 15610
such that the necks 15627 are not captured within the staples deployed from
the inner staple
cavities 15612.
[0675] In various embodiments, referring now to FIGS. 347 and 348, a flexible
tissue thickness
compensator 15720 can comprise a circular or annular flexible outer ring
15724, for example. In
certain embodiments, the outer ring 15724 may be configured such that it is
not captured within
staples deployed from the surgical stapler 15600; rather, in at least one
embodiment, the outer
ring 15724 may be positioned radially outwardly with respect to the outer row
of staple cavities
15613. In at least one such embodiment, the tissue thickness compensator 15720
can comprise a
plurality of tags, such as inner tags 15622 and outer tags 15623, for example,
extending
therefrom such that the tags can be at least partially captured within the
staples as they are being
deformed. More particularly, referring primarily to FIG. 347, each inner tag
15622 can comprise
a head which is positioned over a staple cavity 15612 defined in the surgical
stapler 15600
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wherein the head can be attached to the outer ring 15724 by a neck 15726, for
example, and,
similarly, each outer tag 15623 can comprise a head which is positioned over a
staple cavity
15613 defined in the surgical stapler 15600 wherein the head can be attached
to the outer ring
15724 by a neck 15727, for example. In various embodiments, the heads of the
inner tags 15622
and the outer tags 15623 can comprise any suitable shape, such as round, oval,
and/or elliptical,
for example. The necks 15726 and/or 15727 can also comprise any suitable shape
wherein, in at
least one embodiment, the necks 15726 connecting the heads of the inner tags
15622 to the outer
ring 15724 can be configured to extend between adjacent outer staple cavities
15613 such that
the necks 15726 are not captured within the staples deployed from the outer
staple cavities
15613. In certain alternative embodiments, a tissue thickness compensator can
comprise a
circular or annular flexible inner ring, a circular or annular flexible outer
ring, and, in addition, a
plurality of tags which can be connected to the inner ring and/or the outer
ring. In at least one
embodiment, certain tags can be connected to the inner ring and certain other
tags can be
connected to the outer ring. In certain embodiments, at least some of the tags
can be connected
to both the inner ring and the outer ring. In any event, further to the above,
the inner ring 15624
of the tissue thickness compensator 15620, the outer ring 15724 of the tissue
thickness
compensator 15720, and/or any other suitable tissue thickness compensator, can
be configured to
resiliently expand and/or contract in order to accommodate the expansion
and/or contraction of
the tissue that it has been implanted against. Furthermore, although various
embodiments are
described herein as comprising circular or annular support rings, a tissue
thickness compensator
can comprise any suitably-shaped support structure for connecting the tags
thereto. In various
embodiments, further to the above, the circular knife advanced by the surgical
stapler to cut the
tissue captured between the anvil and the support portion can also cut the
buttress material. In at
least one such embodiment, the knife can separate the inner support ring from
the tags by cutting
the necks thereof, for example.
[06761 In various embodiments, further to the above, a tissue thickness
compensator can
comprise detachable and/or relatively movable positions which can be
configured to allow the
tissue thickness compensator to expand and/or contract in order to accommodate
the movement
of the tissue that it has been implanted against. Referring now to FIGS. 349
and 350, a circular
or annular tissue thickness compensator 15820 can be positioned against and/or
supported by the
deck surface 15611 of the surgical stapler 15600 which can be held in an
unexpanded position
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(FIG. 349) as it is being implanted against the tissue and, after the tissue
thickness compensator
15820 has been implanted, the tissue thickness compensator 15820 can be
configured to expand
outwardly, as illustrated in FIG. 350. In various embodiments, the tissue
thickness compensator
15820 can comprise a plurality of arcuate portions 15822 which can be
connected together by an
inner ring 15824, for example. In at least one embodiment, the arcuate
portions 15822 can be
separated from one another by seams 15828. In at least one other embodiment,
the arcuate
portions 15822 may be connected to one another wherein, in at least one such
embodiment, an
arrangement of perforations may permit the arcuate portions 15822 to separate
from one another.
In either event, in various embodiments, the arcuate portions 15822 can each
comprise
interlocking features, such as projections 15826 and notches 15823, for
example, which can co-
operate to limit relative movement between the arcuate portions 15822 prior to
the tissue
thickness compensator 15820 being implanted. Further to the above, each
arcuate portion 15822
can be connected to the inner ring 15824 by one or more connectors 15827, for
example, which
can be configured to releasably hold the arcuate portions 15822 in position.
After the staples,
such as staples 10030, for example, stored within the support portion 15610
have been utilized to
implant the tissue thickness compensator 15620 against the tissue, referring
primarily to FIG.
350, the connectors 15827 can detach from the inner ring 15824 and allow the
tissue thickness
compensator 15820 to at least partially expand to accommodate movement within
the underlying
tissue. In various circumstances, all of the arcuate portions 15822 may detach
from the inner
ring 15824 while, in other circumstances, only some of the arcuate portions
15822 may detach
from the inner ring 15824. In certain alternative embodiments, the arcuate
portions 15822 can be
connected by flexible sections which can permit the arcuate portions 15822 to
move relative to
each other but not detach from one another. In at least one such embodiment,
the flexible
sections may not receive staples therein and can be configured to stretch
and/or contract to
accommodate the relative movement of the arcuate portions 15822. In the
embodiment
illustrated in FIGS. 349 and 350, the tissue thickness compensator 15820 can
comprise eight
arcuate portions 15822, for example. In certain other embodiments, a tissue
thickness
compensator can comprise any suitable number of arcuate portions, such as two
or more arcuate
portions, for example.
[0677] Further to the above, a tissue thickness compensator 15620, 15720,
and/or 15820, for
example, can be configured to compensate for thicker and/or thinner tissue
captured between the
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anvil and the support portion 15610 of the surgical instrument 15600. In
various embodiments,
similar to the above, the formed, or fired, height of the staples can be
adjusted by moving the
anvil toward and/or away from the support portion 15610. More particularly,
the anvil can be
moved closer to the support portion 15610 to decrease the formed height of the
staples while,
correspondingly, the anvil can be moved further away from the support portion
15610 to increase
the formed height of the staples. In such embodiments, as a result, a surgeon
can adjust the anvil
away from the support portion 15610 to account for thick tissue and toward the
support portion
15610 to account for thin tissue. In various other circumstances, the surgeon
may decide not to
adjust the anvil at all and rely on the tissue thickness compensator to
account for the thinner
and/or thicker tissue. In various embodiments, as a result, the surgical
instrument 15600 can
comprise at least two means for compensating for different tissue thicknesses
and/or variations in
the tissue thickness.
[0678] In various embodiments, as described above, a tissue thickness
compensator can be
attached to a support portion of a staple cartridge. In certain embodiments,
the bottom surface of
the tissue thickness compensator can comprise one of a layer of hooks or a
layer of loops while a
deck surface on the support portion can comprise the other one of the layer of
hooks and the
layer of loops. In at least one such embodiment, the hooks and the loops can
be configured to
engage one another and releasably retain the tissue thickness compensator to
the support portion.
In various embodiments, each hook can comprise an enlarged head extending from
a neck, for
example. In certain embodiments, a plurality of pads comprising the loops, for
example, can be
bonded to the bottom surface of the tissue thickness compensator while a
plurality of pads
comprising the hooks can be bonded to the deck surface of the support portion.
In at least one
embodiment, the support portion can comprise one or more apertures and/or
recesses, for
example, which can be configured to receive an insert therein comprising hooks
and/or loops. In
addition to or in lieu of the above, a tissue thickness compensator can be
removably mounted to
an anvil utilizing such hook and loop arrangements, for example. In various
embodiments, the
hooks and loops can comprise fibrous surfaces, for example.
[0679] In various embodiments, as described above, a staple cartridge can
comprise a support
portion and a tissue thickness compensator attached to the support portion. In
certain
embodiments, as also described above, the support portion can comprise a
longitudinal slot
configured to receive a cutting member therein and the tissue thickness
compensator can
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comprise a retention member that can be retained in the longitudinal slot. In
at least one
embodiment, referring now to FIG. 386, a staple cartridge 16000 can comprise a
support portion
16010 including a deck surface 16011 and a longitudinal slot 16015. The staple
cartridge 16000
can further comprise a tissue thickness compensator 16020 positioned above the
deck surface
16011. In various embodiments, the tissue thickness compensator 16020 can
include a
longitudinal retention member 16025 which extends downwardly into the
longitudinal slot
16015. In at least one such embodiment, the retention member 16025 can be
pressed into the
slot 16015 such that the interaction between the retention member 16025 and
the slot 16015 can
resist relative movement between the support portion 16010 and the tissue
thickness
compensator 16020. In various embodiments, the body of the tissue thickness
compensator
16020 can be comprised of a first material and the retention member 16025 can
be comprised of
a second, or different, material. In certain embodiments, the body of the
tissue thickness
compensator 16020 can be comprised of a material having a first durometer and
the retention
member 16025 can be comprised of a material having a second durometer, wherein
the second
durometer can be higher than the first durometer, for example. In use, in at
least one
embodiment, the staples 10030 can be pushed upwardly by staple drivers 10040
such that the tips
of the staples 10030 can push through the body of the tissue thickness
compensator 16020 and
emerge from the tissue contacting surface 16021 and capture at least a portion
of the tissue
thickness compensator 16020 against the targeted tissue. In various
embodiments, a cutting
member passing through the slot 16015 can transect the retention member 16025
as the staples
10030 are being deployed. Once the tissue thickness compensator 16020 has been
implanted, in
various embodiments, the retention member 16025 can be pulled out of the slot
16015. In
certain other embodiments, the body of the tissue thickness compensator 16020
can be
configured to detach from the retention member 16025.
[0680] Referring now to FIGS. 387 and 389, a staple cartridge 17000 can
comprise a support
portion 17010 including a deck surface 17011 and a longitudinal slot 17015.
The staple cartridge
17000 can further comprise a tissue thickness compensator 17020 positioned
above the deck
surface 17011. In various embodiments, the tissue thickness compensator 17020
can include a
longitudinal retention member 17025 which extends downwardly into the
longitudinal slot
17015. In at least one such embodiment, the retention member 17025 can be
pressed into the
slot 17015 such that the interaction between the retention member 17025 and
the slot 17015 can
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resist relative movement between the support portion 17010 and the tissue
thickness
compensator 17020. In various embodiments, the retention member 17025 can
extend through
the entirety of the tissue thickness compensator 17020 to the top surface
17021 thereof wherein
body portions 17024 of the tissue thickness compensator 17020 can be attached
to opposite sides
of the retention member 17025. In at least one such embodiment, the retention
member 17025
can also be configured to resist the lateral deflection, for example, of the
tissue thickness
compensator 17020. In various embodiments, the body portions 17024 can be
comprised of a
first material and the retention member 17025 can be comprised of a second, or
different,
material. In certain embodiments, the body portions 17024 can be comprised of
a material
having a first durometer and the retention member 17025 can be comprised of a
material having
a second durometer, wherein the second durometer can be higher than the first
durometer, for
example. In various embodiments, further to the above, a cutting member
passing through the
slot 17015 can transect the retention member 17025 as the staples 10030 are
being deployed.
Once the tissue thickness compensator 17020 has been implanted, in various
embodiments, the
retention member 17025 can be pulled out of the slot 17015. In certain other
embodiments, the
body portions 17024 can be configured to detach from the retention member
17025.
[0681] Referring now to FIG. 388, a staple cartridge 18000 can comprise a
support portion
18010 including a deck surface 18011 and a longitudinal slot 18015. The staple
cartridge 18000
can further comprise a tissue thickness compensator 18020 positioned above the
deck surface
18011. In various embodiments, the tissue thickness compensator 18020 can
include a
longitudinal retention member 18025 which extends downwardly into the
longitudinal slot
18015. In at least one such embodiment, the retention member 18025 can be
pressed into the
slot 18015 such that the interaction between the retention member 18025 and
the slot 18015 can
resist relative movement between the support portion 18010 and the tissue
thickness
compensator 18020. In various embodiments, the retention member 18025 can
extend through
the entirety of the tissue thickness compensator 18020 to the top surface
18021 thereof wherein
body portions 18024 of the tissue thickness compensator 18020 can be attached
to opposite sides
of the retention member 18025. In at least one embodiment, the retention
member 18025 can
comprise an enlarged portion 18026 which can be received in a cavity 18016
defined in the slot
18015. In at least one such embodiment, the enlarged portion 18026 can resist
the withdrawal of
the retention member 18025 from the slot 18015.
242
[0682] The devices disclosed herein can be designed to be disposed of after a
single use, or
they can be designed to be used multiple times. In either case, however, the
device can be
reconditioned for reuse after at least one use. Reconditioning can include any
combination of the
steps of disassembly of the device, followed by cleaning or replacement of
particular pieces, and
subsequent reassembly. In particular, the device can be disassembled, and any
number of the
particular pieces or parts of the device can be selectively replaced or
removed in any
combination. Upon cleaning and/or replacement of particular parts, the device
can be
reassembled for subsequent use either at a reconditioning facility, or by a
surgical team
immediately prior to a surgical procedure. Those skilled in the art will
appreciate that
reconditioning of a device can utilize a variety of techniques for
disassembly,
cleaning/replacement, and reassembly. Use of such techniques, and the
resulting reconditioned
device, are all within the scope of the present application.
(06831 Preferably, the invention described herein will be processed before
surgery. First, a
new or used instrument is obtained and if necessary cleaned. The instrument
can then be
sterilized. In one sterilization technique, the instrument is placed in a
closed and sealed
container, such as a plastic or TYVEKTI" bag. The container and instrument are
then placed in a
field of radiation that can penetrate the container, such as gamma radiation,
x-rays, or high-
energy electrons. The radiation kills bacteria on the instrument and in the
container. The
sterilized instrument can then be stored in the sterile container. The sealed
container keeps the
instrument sterile until it is opened in the medical facility.
[0684] While this invention has been described as having exemplary designs,
the present
invention may be further modified within the spirit and scope of the
disclosure. This application
is therefore intended to cover any variations, uses, or adaptations of the
invention using its
general principles. Further, this application is intended to cover such
departures from the present
disclosure as come within known or customary practice in the art to which this
invention
pertains.
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