Note: Descriptions are shown in the official language in which they were submitted.
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203-630 (1253)
1 APPARATUS AND METHOD FOR APPLYING SURGICAL
STAPLES TO ATTACH AN OBJECT TO BODY TISSUE
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an apparatus and
method for applying surgical staples to=attach objects to
body tissue. More particularly, this invention relates to a
staple applier particularly adapted for attaching surgical
mesh to body tissue to reinforce a surgical repair of the
body tissue, as in hernia repair.
2. Background of the Invention
Hernias may be divided into three general classes:
direct hernia, indirect hernia and femoral hernia. In a
direct or indirect inguinal hernia, often a part of the
intestine protrudes through a defect in the supporting
abdominal wall to form a hernial sac requiring.surgery which
generally includes a surgical incision in the groin ranging
up to six inches in length. Several layers of the abdominal
wall are generally separated to reach the herniated
portions. During the procedure, the hernia is closed
outside the abdominal wall in a manner which resembles the
tying of=a sack at the neck. Often a surgical mesh is
attached by sutures directly over the hernia repaired
opening to provide a reinforcement to the opening.
Traditionally,, such hernia repairs involved major
-
invasive surgical procedures which often caused excessive
trauma to the patient and necessitated unusually long post-
operative recuperative periods. In addition, numerous
complications, related directly or indirectly to the surgery
often resulted, including bleeding, infection, testicular
atrophy, organ damage, nerve damage, blood vessel damage,
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1 etc. Further, cutting through the numerous layers of tissue
to obtain access to the herniated area often caused severe
trauma to the patient. A detailed discussion of traditional
hernia repair may be found in "Hernia Repair Without
Disability, Second Edition", by Irving L. Lichtenstein.
Such invasive surgical procedures have also been
utilized in other areas of the body, including surgery on
the gall bladder, appendix, lungs and the like. For the
reasons previously stated, the use of laparoscopic and
endoscopic surgical procedures have been relatively popular
and such popularity has provided additional incentive to
develop the procedures further.
In laparoscopic procedures, surgery is performed
in the interior of the abdomen through a small incision; in
endoscopic procedures, surgery is performed in any hollow
viscus of the body through narrow endoscopic tubes inserted
through small entrance wounds in the skin. Laparoscopic and
endoscopic procedures generally require that any
instrumentation inserted into the body be sealed, i.e.,
provisions must be made to ensure that gases do not enter or
exit the body through the laparoscopic or endoscopic
incision as, for example, in surgical procedures in which
the surgical region is insufflated. Moreover, laparoscopic
and endoscopic procedures often require the surgeon to act
on organs, tissues and vessels far removed from the
incision, thereby requiring that any instruments be used in
such procedures be long and narrow while being functionally
controllable from one end of the instrument, i.e. the
proximal end.
In hernia surgery, as compared to gall bladder
surgery, certain procedures and instruments are the same,
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1 yet certain of the instrument requirements differ. For
example, in hernia surgery a suitable mesh material is
generally sutured over the opening in the tissue. The mesh
material is often also attached by sutures and left within
the opening to act as a reinforcing agent for tissue
regrowth in the area of the surgery. One example of a mesh
material currently utilized in hernia surgery includes a
polypropylene material marketed by the Ethicon division of
Johnson & Johnson, New Brunswick, New Jersey, under the
trademark MARLEX. Another example of a mesh material is a
tri-fluoroethylene material marketed by W.L. Gore &
Associates, Newark, Delaware, under the trademark GORE-TEX.
As noted, during conventional invasive surgical
procedures, such mesh materials are often sutured within the
surgical opening or over the sutured opening by conventional
suturing techniques. However, with the advent of
laparoscopic surgery the need for suitable mesh attachment
techniques through the relatively narrow endoscopic tubes or
cannulas is clearly defined. Up to the present, such
devices or staples suitable for mesh attachment have not yet
been developed.
U.S. Patent No. 4,944,443 to Oddsen et al.
discloses an instrument and method for applying and forming
staples into body tissue to suture a hernial opening.- The
staple is applied to two pieces of body tissue on opposite
sides of the opening which are gripped, approximated and
held together by a tissue positioning assembly. U.S. Patent
No. 4,919,152 to Ger relates to a surgical instrument for
placing a single clip which is proposed for use in direct
30=hernia repair for closing sacs having narrow neck openings.
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Up to the present there remains a need for an
apparatus which is particularly adapted to endoscopically
apply staples for attaching objects such as surgical mesh to
body tissue in a manner to positively secure the object to
the body tissue without danger of separation thereof after
the attachment is completed. The present invention relates
to such an apparatus as well as a method for attaching such
objects with staples particularly configured and adapted to
accomplish these objectives.
SUMMARY OF THE INVENTION
In accordance with an embodiment of the present
invention there is provided an apparatus for endoscopic
application of surgical staples which comprises: (a) a
frame; (b) a generally elongated endoscopic portion
extending distally from the frame and having a generally
longitudinal axis and a distal end potion having a base
portion; (c) means mounted upon the base portion for storing
at least one surgical staple; and (d) a movable staple
pusher positioned at least partially within the endoscopic
portion for advancing said at least one surgical staple, the
staple pusher having at lest two outer spaced lands
extending distally for engaging and advancing a backspan of
such at least one staple for application to body tissue.
In one preferred embodiment, the distal end
portion is movable between at least a first position
extending in substantially the same direction as the
longitudinal axis and at least a second position at an angle
to the longitudinal axis.
Preferably, an anvil member is provided for
closing such at least one surgical staple while applying
same to body tissue.
In another preferred embodiment, a spring member
is provided which comprises resilient means for moving a
closed surgical staple upwardly with respect to such anvil
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member to release the staple therefrom after formation of
the staple.
Preferably, the backspan of the at least one
staple includes spaced bridge portions, and wherein the
staple pusher has a staple pusher surface disposed between
the lands for engaging a central portion of the staple
backspan between the spaced bridge portions.
In preferred arrangements the endoscopic portion
of the apparatus is rotatable about the longitudinal axis.
The apparatus is adapted for endoscopic
application of a surgical staple for attaching objects to
body tissue.
Preferably, the apparatus for endoscopic
application of surgical staples is adapted to attach
surgical mesh to body tissue and comprises means for storing
a plurality of surgical staples in generally stacked
relation to permit configuring and dimensioning the
endoscopic means for insertion into an endoscopic cannula
tube. The staples are configured and adapted to attach the
surgical mesh to body tissue, particularly for hernia
related surgery. Further, the staple advancing system
extends from the frame means to the endoscopic means and may
be activated by a trigger mechanism pivotally attached to
the frame means and forming a part thereof.
The surgical staples are preferably stored in
stacked relation at the distal end of the endoscopic means.
Also, the endoscopic means defines a longitudinal axis and
the surgical staples are preferably stacked to form an angle
with the longitudinal axis, thereby improving visibility.
The surgical staple storing means may be pivotally
attached at the distal end portion of the endoscopic means
wherein the surgical staple storing means is selectively
pivotable by the user. Pivotal control means is located at
the proximal end of the endoscopic section to pivot the
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surgical staple storing means from a proximal location. The
location of the pivotal control means is provided for
convenience and accessibility to the operator. The pivotal
control means of the staple storing means may comprise a
member with respect to the endoscopic means in proximal and
distal directions and adapted to position said surgical
staple storing means at substantially zero degrees with
respect to said longitudinal axis when said pivotal control
means is in a first position and said surgical staple
storing means forms an angle of up to about 45 degrees when
said pivotal control means is in a second position.
The first position may be the proximalmost
position of the pivotal control means and the second
position may be the distalmost position corresponding to the
staple storing means being pivoted up to about 45 degrees
with respect to at least one side of the longitudinal axis.
Further, the pivotal control means of the staple storing
30
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1 means may include a generally cylindrical movable member
slidably positioned about a proximal portion of the
endoscopic means.
The staple storing means may also comprise a
rotatable sleeve positioned within the movable member and
adapted to rotate in a first direction when the movable
member is moved toward the proximalmost position and to
rotate in the opposite direction when the movable member is
moved toward the distalmost position.
The surface at the distalmost end portion of the
rotatable sleeve may form an angle with respect to the
longitudinal axis of the endoscopic means and the distalmost
end surface of the rotatable sleeve may be positioned and
arranged to engage elongated control means positioned within
the endoscopic means for engagement with at least a portion
of the staple storing means at a distal location of the
endoscopic means whereby rotatable movement of said
rotatable sleeve correspondingly produces longitudinal
movement of said elongated control means. Preferably, the
elongated control means comprises at least two elongated
rods positioned within the endoscopic means and in
engagement with the distalmost end portion of the rotatable
sleeve at the proximal ends thereof and arranged to engage
at least a portion of the staple storing means at
respectively opposed locations such that rotation of the
rotatable sleeve in a first direction produces distal
movement of at least one of the rods and corresponding
proximal movement of the other rod and rotation of the
rotatable sleeve in the opposite direction respectively
produces correspondingly respectively opposite movement of
the rods.
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The staple storing means may further include an
indentation adapted to receive each rod in engagement
therewith and each rod is correspondingly configured at the
distal end to engage the respective indentation to produce
smooth rotation of the staple storing means when the rods
are respectively moved distally and proximally. Further,
the means for individually advancing the staples distally is
user controllable at a proximal location. The means for
individually advancing said staples distally comprises a
plate member positioned adjacent and proximal of the
lowermost staple and adapted to be movable distally whereby
the plate member engages the lowermost staple and advances
the staple in the distal direction. Also, the means to
individually advance the staples comprises staple pusher
means which comprises said plate member and the plate member
is dimensioned, configured and arranged to engage and
advance each staple distally.
The staple pusher means may include an elongated
member of super elastic material such as *NITINOL brand
metal and.is adapted to advance the staples and transmit
closing force thereto. This member is further adapted to
resiliently deform to facilitate pivoting movement to the
staple storing means. In preferred forms, the staple pusher
means further comprises an elongated staple firing rod.
In the preferred apparatus the staple pusher means
is biased to a pre-fired position by a constant force
negator spring which prevents the operator tendency to
rotate the hand, which occurs when a spring force increases.
Also a trigger mechanism may be pivotally mounted
for pivotal movement against the force of the negator spring
when pivoted proximally to a position corresponding to
*trade-mark
CA 02444769 2003-10-29
1 advancing the pusher means distally to advance the staple
next in line for closure.
The staple storing means may also include anvil means
positioned distally of the stack of staples and configured,
dimensioned and adapted to be engaged by each said staple
when said staple is advanced distally by said plate member.
The staples are each formed of a first length of
wire having at least two leg portions at each end extending
generally perpendicular to said first length of wire. The
]0 anvil means comprises at least two upstanding leg members
positioned to be engaged by the first length of wire of each
staple when the staple is advanced distally by the plate
member. The leg members of the anvil means are dimensioned,
positioned and arranged such that engagement by the first
length of wire of each staple causes the leg members of the
staple to fold inwardly toward the first wire due to the
configuration of the staple and the corresponding
configuration of the distalmost staple engaging edge of the
plate member. The plate member is connected to elongated
means comprised of super elastic member and the firing rod.
The means to move the elongated means and the
plate member in distal and proximal directions is positioned
within the frame means. Resilient means is positioned below
each staple such that upon completion of closure thereof,
and withdrawal of the staple advancing plate member the-
resilient means resiliently lifts the staple above the level
of the anvil means. Also, the elongated means extends from
the frame means through the endoscopic means whereby a
distal portion thereof and the plate member are positioned
within the staple storing means. The means to advance the
elongated means and the plate member preferably includes ratchet
and
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1 associated pawl means adapted to prevent proximal movement
thereof except when the staple advancing means is advanced
to the distalmost position whereby the pawl means is
released so as to permit return of the elongated member and
the staple advancing plate member to the proximalmost
position to advance the next staple of the stack of staples.
Preferably, the ratchet and pawl means comprises a
ratchet member fixedly connected to the frame means and has
a ribbed surface, and pawl means connected to the elongated
plate advancing means and positioned adjacent the ratchet
member and adapted to engage the ribbed surface. The ribbed
surface is correspondingly configured and dimensioned to
prevent proximal movement of the pawl means when the
elongated plate advancing means is advanced at least
partially in the distal direction. The ribbed surface of
the ratchet member is comprised of a plurality of
substantially and successive V-shaped peaks and valleys and
the pawl means is configured at one end portion to engage
the peaks and vallcys in a manner which permits distal
slidable movement thereof but prevents proximal movement
thereof. Also, means is provided to releasc the pawl means
when the pawl means is in the distalmost position.
corresponding to the distalmost position of the plate member
and closure of the staple has been completed. A finger*
operative lever is adapted to produce distal movement of the
elongated member and the plate member when said lever is
pivotally moved.
The frame mearis preferably pistol-like shape and
includes a first member having a distal end connected to the
endoscopic means and a manually griping member at the
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I proximal end is adapted to be gripped manually by the user.
The endoscopic means is rotatable about the longitudinal
axis and the pivotal control sleeve of the staple storing
means is connected for rotation with the endoscopic means
such that rotation thereof produces corresponding rotation
of said endoscopic means. As described hereinabove, distal
and proximal movement thereof produces pivotal movement of
the staple storing means. The staple storing means is
adapted to be pivoted up to about 45 degrees with respect to
each side of the longitudinal axis whereby full pivotal
articulation thereof is provided of about 90 degrees.
A surgical staple is adapted to attach objects
such as mesh materials to body tissue which comprises, a
length of wire having a central portion, a wire leg member
extending generally perpendicular to the central wire
portion at each end portion and adapted to penetrate the
object and body tissue when positioned in adjacent engaged
relation therewith and advanced thereinto. A bridge portion
connects the central wire portion to each leg member and has
a first generally arcuate portion generally concave and
facing in a direction generally toward the center of the
central wire portion. The inwardly facing concave
portions are connected to each leg member by an arcuate
portion having a generally concave configuration in the
opposite direction so as to respectively engagably support
each bridge portion against a pair of.anvil members whereby
applying force to the bridge portions causes the leg members
to bend inwardly toward the central wire portion at
respective locations inward of the first mentioned arcuate
portions in a manner to form an acute angle relative
thereto. The maximum distance between the central wire
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1 portion and each folded leg member is sufficient to grip the
object and to penetrate the body tissue sufficient to attach
the object to the body tissue. Each said leg member has a
pointed tip to penetrate the object and the body tissue.
Each leg member of the staple has a tapered
portion at the free end. The tapered portion on one leg
member is located opposite the tapered portion on the other
leg member whereby folding the leg members inwardly toward
each other causes each tapered portion to respectively cam
the other leg member whereby the leg members are folded
toward each other in adjacent relation without interference
with each other. The central wire portion is positioned
inwardly of each bridge portion to facilitate gripping the
object between the central wire portion and the leg members.
Further, each leg member has a generally arcuate shape and
has a concave portion thereof generally facing the other leg
member. The surgical staple is preferably made of titanium.
Also, the central wire portion includes a portion thereof
which is positioned inwardly of the bridge portions in the
body tissue gripping direction to thereby form a bight
portion for gripping the object and body tissue in
combination with the leg members.
A method is disclosed for endoscopically applying
surgical staples to attach objects such as surgical mesh to
body tissue comprising the steps of storing at least one
surgical staple in endoscopic means. having storing means
positioned at the distal end portion and adapted for
advancing and closing said staple, positioning the object
adjacent the body tissue for attachment to the body tissue,
and advancing the surgical staple distally so as to
penetrate the object and the body tissue and to close the
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1 staple in a manner to attach the portion of the object to
the body tissue. Preferably, a plurality of surgical
staples are stored in stac}:ed relation in the endoscopic
means.
Also disclosed is a combination of a
cannula adapted for insertion into a body cavity, the
cannula including valve means for sealing the cannula. An
endoscopic surgical staple applier has a frame, and an
endoscopic portion defining a longitudinal axis, and
extending distally from the frame, the endoscopic portion
configured and adapted for insertion into the cannula
through the valve means in sealing engagement therewith.
The endoscopic portion further includes a plurality of
surgical staples in stacked relation, and means for
individually pushing the staples through the distal end
thereof is provided whereby staple closing means causes the
staples to be closed while attaching an object such as
surgical mesh to the body tissue. Seal means is positioned
and adapted to obstruct passage of gaseous media from the
body cavity.
A kit is also disclosed for endoscopic application
of a surgical staple adapted to attach surgical mesh to body
tissue in hernia repair, which comprises, surgical mcsh,
cannula means, and apparatus.for endoscopic application of a
surgical staple adapted to attach the surgical mesh to body
tissue. The apparatus and staples of the kit are
constructed according to the invention. The components may
be supplied as part of a kit or they may be pac}:aged in a
blister-type or other package.
35
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1 BRIEF DESCRIPTION OF THE DRAWINGS
Preferred embodiments of the invention are
described hereinbelow with reference to the drawings
wherein:
Fig. 1 is a perspective view from above, of an
apparatus constructed according to the present invention for
applying surgical staples to attach objects to body tissue;
Fig. 1A is a perspective view of the distal end
portion of the apparatus of Fig. 1 illustrating an
alternative embodiment for pivoting the staple storage
magazine;
Fig. 2 is an exploded perspective view with parts
separated, of the handle of the instrument of the invention
and the associated components;
Fig. 3 is a cross-sectional view taken along lines
3-3 of Fig. 1, illustrating the handle mechanism of the
instrument in the pre-fired condition;
Fig. 4 is a cross-sectional view taken along lines
4-4 of Fig. 3 illustrating the mechanism at the proximal end
of the instrument for providing controlled distal movement
to advance and to close staples at the distal end;
Fig. 5 is an enlarged cross-sectional view of the
pawl and ratchet system in the handle which prevents
proximal movement of the staple advancing system after
distal movement has begun;
Fig. 6 is a view similar to Fig. 5 illustrating
the pawl and ratchet system of Fig. 5 after a staple has
been fired and during the proximal movement of the firing
mechanism;
F'ig. 7 is a cross-sectional view similar to Fig. 3
with the staple advancing actuating handle in the full
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1 proximal pivoted position corresponding to firing of a
staple;
Fig. 8 is an enlarged cross-sectional view taken
along lines 8-8 of Fig. 1 illustrating the rotating
mechanism for the endoscopic portion and the system for
pivoting the staple storage magazine from the proximal end;
Fig. 9 is a cross-sectional view taken along lines
9-9 of Fig. 8;
Fig. 10 is a cross-sectional view taken along
lines 10-10 of Fig. 8 illustrating the system for providing
pivotal motion of the staple storage magazine located at the
distal end;
Fig. 11 is a cross-sectional view taken along
lines 11-11 of Fig. 9 illustrating further details of the
system for providing pivotal motion to the staple magazine
at the distal end;
Fig. 12 is a view of the interior surface of the
inner sleeve of the manually operable collar of Figs. 8-11,
projected as a flat surface to illustrate the helical groove
provided for coaction with a pin to provide pivotal motion
for the staple magazine at the distal end;
Fig. 13 is a perspective view of an internal
sleeve and pin which coacts with the inner sleeve shown in
Figs. 11 and 12 which forms part of the system for pivoting
the staple magazine at the distal end;
Fig. 14 is an exploded perspective view with parts
separated, of the endoscopic section of the instrument of
the invention, illustrating the staple advancing system and
components thereof;
Fig. 15 is an exploded perspective view with parts
separated, of the staple storage magazine which is
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1 controllably pivotally mounted at the distal end portion of
the endoscopic section;
Fig. 16 is a cross-sectional view taken along
lines 16-16 of Fig. 1 illustrating the distal end of the
instrument including the pivotal staple magazine at three
positions;
Fig. 17 is a cross-sectional view taken along
lines 17-17 of Fig. 16 illustrating the staple next in line
and the pusher plate provided for advancing the staple
toward a staple closing anvil;
Fig. 18 is a cross-sectional view of the distal
end of the instrument shown in engagement with a surgical
mesh positioned against body tissue prior to firing the
staple;
Fig. 19 is a cross-sectional view taken along
lines 19-19 of Fig. 18;
Fig. 20 is a cross-sectional view similar to Fig.
18 during the firing of the staple and after penetration
into the mesh and body tissue, but prior to closure;
Fig. 21 is a view similar to Fig. 19, taken along
lines 21-21 of Fig. 20;
Fig. 22 is a cross-sectional view of the distal
end of the instrument of the invention after closure of the
staple in position to attach the surgical mesh to the body
tissue;
Fig. 23 is a cross-sectional view taken along
lines 23-23 of Fig. 22 illustrating the staple ejection
system for releasing the closed staple from the anvils after
firing;
Fig. 24 is a cross-sectional view similar to Fig.
22 illustrating the staple after closure about the surgical
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1 mesh and body tissue and the distal end of the instrument
withdrawn from the surgical mesh;
Fig. 25 is a cross-sectional view taken along
lines 25-25 of Fig. 24;
Fig. 26 is a cross-sectional view of the distal
end portion of the staple storing magazine of the instrument
after firing a staple;
Fig. 27 is a frontal view of a repair in body
tissue illustrating one example of an arrangement of staples
of the invention for attachment of reinforcing surgical mesh
to the tissue;
Fig. 28 is a perspective view of a staple
constructed according to the invention for attaching
surgical reinforcing mesh to body tissue over a surgical
repair; and
Fig. 29 is another example of arranging the
staples for attachment of the reinforcing surgical mesh to
the body tissue in the area of a hernia repair.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
GENERAL
In general, the objective of the apparatus is to
store a plurality of staples.in the magazine as will be
described in greater detail, and to individually advance
each staple distally for closure about anvils while
attaching a surgical mesh to the body tissue.
Following a general description of the present
instrument, the description will be divided into separate
sections to describe the structure and the desired movements
produced thereby. Those sections include the handle
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1 section, the staple storage magazine pivoting system, the
endoscopic section and staple firing system, the staple
storage magazine, the staple closing system and the
inventive staple. Also a kit for attaching objects such as
surgical mesh is described.
THE INSTRUMENT
Referring initially to Fig. 1 there is illustrated
in perspective view the apparatus 10 particularly adapted
for endoscopic application of surgical staples to attach
surgical mesh to body tissue during hernia repair. Except
where noted otherwise, the materials utilized in the
components of the apparatus generally include such materials
as polycarbonate for housing sections and related
components, and stainless steel for such components which
transmit forces. Onc preferred polycarbonate material is
*LEXAN brand polycarbonate available from General Electric
Company. Other specific preferred materials such as nylon
or glass filled nylon (for strength),are also utilized.'
However, equivalent alternative materials will readily come
to the mind of thosc skilled in the art.
The apparatus 10 includes handle portion 12, and
endoscopic section 14 having at the distal end portion a
staple storage magazine 16 wtiich pivots with respect to at
least one side of the longitudinal axis extending centrally
through the endoscopic section as shown in Fig. 1.
Generally, staple storage magazine 16 will selectively pivot
up to about 45 degrees with respect to the aforesaid
longitudinal axis. In the illustration of Fig. 1 the staple
storage magazine 16 is shown in general alignment with the
longitudinal axis of the endoscopic section and in phantom
to illustrate a range of movement. The total range of
*trade-mark
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1 pivotal motion of the staple storage magazine 16 as shown is
approximately 90 degrees, i.e. 45 degrees to each side of
neutral.
Referring generally to Fig. 1, the handle 12 of
instrument 10 includes manual grip 18 and pivotal trigger 20
which is pivoted toward and away from manual grip 18.
Trigger 20 is pivoted toward manual grip 18 during the
staple advancing and firing sequence which will be described
in further detail. Trigger 20 pivots away from manual grip
18 to return the instrument to the pre-fired condition in
position for firing the staple next in line.
A double knurled finger operative collar 22 is
rotatable and adapted to rotate the entire endoscopic
section 14 a full 360 degrees as will be described
hereinbelow, while proximal movement of the finger ring 22
produces pivotal motion of the staple storage magazine to
one of the positions shown in phantom in Fig. 1. To achieve
the other position shown in phantom in that Fig., the collar
22 may be simply rotated 180 degrees thereby rotating the
entire endoscopic section and causing the position of the
magazine 16 to be reversed as shown to the other position
shown in phantom. Thus, it can be seen that the combination
of full rotation of the endoscopic section and the pivotal
movement of the staple storing magazine facilitates a wide
range of articulation of the distal end of the staple .
magazine 16, thus facilitating application of staples over a
wide range of locations ( 180 degrees) and in any of a
plurality of orientations. In the embodiment of the
invention shown in the Figs., when the collar 22 is moved to
its proximalmost position the staple magazine is in one of
the positions shown in phantom in Fig. 1, i.e. at an angle
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1 with respect to the longitudinal axis of the instrument.
When the collar 22 is advanced to the distalmost position
the staple magazine assumes the position shown in Fig. 1,
i.e. in alignment with the longitudinal axis of the
instrument.
Thus, in the preferred embodiment of Fig. 1, it
can be seen that the full 90 degrees of movement of the
magazine may be achieved simply by longitudinal movement of
collar 22 in combination with full rotation of the
endoscopic section. The longitudinal movement of collar 22
causes pivotal movement of the staple storing magazine to 45
degrees in one directio;i and rotation of the endoscopic
section provides completion of the articulation of the
magazine. Both of these movements in combination,
facilitate a wide rancle of maneuverability of the distal end
of the staple magazine 16, thus facilitating application of
staples over a wide range of locations ( 180 degrees) and
in any of a plurality of orientations.
Alternatively, the positions of the staple storing
magazine 16 may be achieved as shown in Fig. 1A, i.e. by
movement of the magazine between zero degrees and about 45
degrees on either side of the longitudinal axis. In such
arrangement, to achieve the positions shown in phantom in
Fig. 1A, the collar 22-is moved distally and proximally,
equal distances on either side of a neutral detent.
Movement in one direction would pivot the magazine to one
side and movement in the other direction would cause pivotal
movement of the magazine in the opposite direction. The
directions selected would be arbitrary. However, in this
last described embodiment the orientation of the magazine
would be the same throughout the 90 degree pivoting range,
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1 whereas in the preferrcd embodiment of Fig. 1, the
orientation of the magazine when on one side is opposite the
orientation when on the other. Further, in this embodiment
the endoscopic section will be somewhat longer to
accommodate the additional movement of collar 22.
THE HANDLE SECTION
Referring to Fig. 2, there is shown an exploded
perspective view with parts separated, of the handle of the
instrument with associated components. The handle is
comprised of an outer housing preferably formed of separate
sections as shown, of polycarbonate material. The separate
parts shown are attached by welding, adhesives, etc. Fig. 3
illustrates a cross-sectional view of the handle mechanism
taken along lines 3-3 of Fig. 1. The ultimate purpose of
the handle mechanism is to provide controlled distal
movement to the pusher assembly 24, a portion of which is
shown in Fig. 2. The pusher assembly extends through the
endoscopic section 14, a portion of which is shown in
phantom in Fig. 2. In the embodiment shown, the endoscopic
section shown is intended to be permanently and rotatably
attached to the instrument via rim 16a formed on bushing 16
and rim 15a on half round sleeve 15. The instrument shown
is contemplated to be entirely disposable. Half round
sleeve 15 is integrally.formed with barrel 17 which is in
turn affixed to handle 12 at the nose piece 13.
However, it is also contemplated and within the
scope of the invention to construct the endoscopic section
to be selectively detachable whereby the handle may be
30. sterilized and reused, or the endoscopic section can be
sterilized, and the staple storage magazine re-loaded with
CA 02444769 2003-10-29
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1 staples for re-use. Alternatively a replacement staple
magazine, and optionally a replacement endoscopic section,
may be detachably secured to a disposable handle for
multiple use during a single surgical procedure. Thus, any
combination of alternatives may be incorporated within the
scope of the invention.
Referring now to Fig. 2 in conjunction with Figs.
3, 7 and 14, pusher assembly 24 includes flanged thrust bar
26 connected to firing rod 28 by lost motion connector 30 as
shown in Fig. 3. Lost motion connector 30 is a bar having a
generally "U-shaped" configuration as shown. The lost
motion connector 30 provides a positive connection between
flanged thrust bar 26 and firing rod 28, yet provides a
small space between the firing rod and the thrust bar 26 as
will be described. Since the respective slots 28a and 26a
in the firing rod 28 and in the thrust bar 26 are
dimensioned slightly larger in width than the thickness of
the legs 30b and 30c of the lost motion connector 30 which
are received in these slots, a small degree of relative
movement (i.e., about one tenth (1/10) of an inch) is
provided permitted between the components in the staple
firing chain. This small degree of movement is provided for
several reasons as follows: 1) minor pivotal proximal
movements of the trigger mechanism will not immediately
result in engagement between'the pusher assembly and the
staple next in line, thus avoiding inadvertent distal
movement of the staple during handling by operating room
personnel, or positioning by the user; 2) engagement of the
pusher assembly with the next staple will not occur until
the pawl and ratchet plate of the clutch mechanism
(described hereinbelow) takes place, thus preventing
CA 02444769 2003-10-29
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1 inadvertent partial advancement of several staples at a
time. This would occur if the operator were allowed to
partially activate the trigger mechanism several times over
the same part of its cycle. The clutch mechanism prevents
such movements. Further, this free movement of the thrust
bar 26 also permits the staple advancing and forming
components to engage each other smoothly without jamming or
intercomponent interference with themselves and with the
components of the system for pivoting the staple storage
magazine 16 as will be described hereinbelow. Explanation
of the pivoting system for the staple storage magazine will
illustrate the advantages of the lost motion connector bar
in further detail.
Trigger mechanism 20 is pivotally attached at
pivot pin 32 for pivotal movement toward and away from
handle grip 18, and is adapted to produce upward and
downward rotational -,,,,ovement of triangular member 34 when
horizontal pin 36, attached to trigger mechanism 20,
traverses an upward arc whose center of rotation is located
at pivot pin 32. Thus, it can be seen that when handle grip
18 is positioned in the palm of the user's hand and trigger
mechanism 20 is sg'scezed toward handle grip 18, horizontal
pin 36 traverses an upward arc while engaging the longer
side 34a of triangular me~-nber 34 as shown. This movement
causes triangular member 34 to rotate upward in a
counterclockwise direction while upright member 35 to which
it is attached, pivots forwardly about a point of rotation
defined by pivot pin 37 located at the lowermost end of a
handle grip 18 shown in Fig. 2.
As can be seen in Figs. 2 and 3, pusher assembly
24 is connected to upright member 35 through aperture 33
CA 02444769 2003-10-29
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1 such that inward squeezing of trigger mechanism 20 will
cause the entire pusher assembly to advance distally against
the constant force provided by negator spring 40 as shown.
The negator spring 40 is formed of a resilient flat spring
material coiled about the rotational bar 42 which is
rotationally mounted about cross member 44 which forms part
of bracket 46. The free end of negator spring 40 is
attached to an anchor pin 48 via aperture 49 as shown, while
the spring 40 is normally biased toward the coiled
configuration as shown in Fig. 3. It can therefore be
appreciated that after squeezing trigger mechanism 20 the
full stroke from the position shown in Fig. 3 toward handle
grip 18 to the position shown in Fig. 7, release of the
trigger mechanism will permit the negator spring 40 to
assume control and to return rotational bar 42 to the pre-
fired proximal location by the automatic winding action of
the negator spring 40 to its original unloaded
configuration. This motion in turn causes the entire pusher
assembly 24 to return to the proximalmost pre-fired position
as shown in Fig. 3. The constant force of negator spring 40
uniquely prevents the natural tendency of the user to rotate
the hand as with springs which increase in force when
progressing through a full spring cycle.
Referring once again to Figs. 2 and 3, trigger
stop device 50 is attached to trigger mechanism 20 and is
configured and dimensioned for engagement with handle grip
18 in a manner to thereby limit the proximal pivotal
movement of trigger mechanism 20. Depending upon the
particular limits required in the apparatus, trigger stop
device 50 can be dimensioned accordingly.
CA 02444769 2003-10-29
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1 Referring now to Figs. 4-6, the structure and
function of the uni-motion clutch mechanism will be
described. This clutch mechanism prevents proximal movement
of the pusher assembly in the event the trigger mechanism is
released after the squeezing motion of the trigger mechanism
and the advancement of the pusher assembly has begun but
before the full stroke is completed. The clutch mechanism
is self-releasing when the pusher assembly reaches the
distalmost position, thus permitting the entire pusher
assembly to return to the pre-fired, or proximalmost
condition, and the trigger mechanism to also return to the
pre-fired position.
Referring now to Fig. 4 in conjunction with Figs.
5 and 6, ratchet plate 52 is fixed to barrel 17 and
therefore fixed with respect to the handle housing and
possesses a surface defined by a plurality of right angle
triangular shaped parallel ridges 56 as shown in Figs. 4-6.
Pawl 58 is rockably mounted for distal and proximal movement
with pusher assembly 24 through barrel 17, and is biased
toward ratchet plate 52 by resilient wire spring 60 as
shown. The location of pawl 58 shown in Fig. 4 corresponds
to the pre-fired condition of the apparatus with negator
spring 40 in the fully wound position and pawl 58 located
proximal of ratchet plate 52. Further, pawl 58 is
preferably of stainless'steel while ratchet plate 52 is-made
of brass or other compatible material.
While trigger mechanism 20 is squeezed toward
handle grip 18 producing distal motion of the entire pusher
assembly 24, pawl 58 engagably slides distally past the
ratchet surface 56 of ratchet plate 52 as shown in Fig. 5
such that one corner of the tip 62 of the pawl 58
CA 02444769 2003-10-29
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I sequentially engages each right angled ridge of ratchet
plate 52 to thereby prevent proximal movement of the pusher
assembly in the event the trigger mechanism is released by
the operator. The engagement of pawl 58 with ratchet plate
52 provides audible confirmation that the pusher assembly is
moving distally since the user will hear a series of
progressive audible clicks. This action - which is best
shown in Fig. 5 - continues with the tip 62 of pawl 58
sliding past the ratchet surface of the ratchet plate 52
until the pawl is positioned distally of the distalmost
tooth.
After completion of the staple firing stroke and
upon release of the trigger mechanism 20 the pawl 58 moves
proximally with the pusher assembly as described under the
action of spring 40. The end portion 62 'of pawl 58 which is
now free, engages the distal end of the ratchet plate 52
causing the pawl to rock to the reverse direction shown in
Fig. 6 so as to slide proximally past the ratchet surface of
ratchet plate 52 without interference to the proximal
movement of the pusher assembly 24. Thus, it can be seen
that the clutch mechanism as described will effectively
permit squeezing the trigger mechanism 20 toward the handle
grip 18 while maintaining all positions midway through the
stroke in the event the operator releases the grip, while
permitting return motion thereof after the stroke has been
completed. The clutch mechanism also allows the operator to
advantageously preposition a staple such that the legs of
the staple protrude from the distal cnd of the staple
magazine discussed hereiriafter, and then to release pressure
from the trigger mechanism. The operator may then turn full
attention to locating the prepositioned staple in the
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1 desired target location, at which point the pivoting of the
trigger mechanism may be resumed and the cycle completed.
This staple prepositioning greatly facilitates staple
placement.
THE STAPLE STORAGE MAGAZINE PIVOTING SYSTEM
Referring to Figs. 8-14, the system for pivoting
the staple storage magazine located at the distal end of the
endoscopic section 14 will now be described. Fig. 8
l0 illustrates double knurled finger operable collar 60 which
is mounted for rotation with the endoscopic section 14 by
inwardly extending pin 62 which is slidably positioned
within longitudinal groove 64 in the outer housing half
section 14a of endoscopic section 14, as shown in further
detail in Fig. 14. Thus collar 60 is readily slidable
distally and proximally while pin 62 slides within groove
64. Thus while permitting slidable movement of collar 60,
pin 62 prevents independent rotation of collar 60 relative
to the endoscopic section 14. Accordingly, when collar 60
is gripped between the user's fingers and rotated, the
endoscopic section 14 rotates with the collar.
Positioned within finger operable collar 60 is
helically grooved inner sleeve 66 fabricated of a suitable
plastic material such as *nylon, glass filled for strength,
Helically grooved inner'sleeve 66 is generally cylindrical
in shape and includes a helical groove 68 shown in phantom
lines in Fig. 8 and illustrated schematically in the
projected frontal view of the sleeve shown in Fig. 12. The
sleeve 66 is fixedly attached to outer collar_60 for
rotation therewith. In the projected view of Fig. 12, the
helical groove appears as a diagonal groove having a linear
*Trade-mark
CA 02444769 2003-10-29
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1 shape. In Fig. 11, finger operable collar 60 is shown in
cross-section and the inner helically grooved sleeve 66 is
shown whereby helical groove 68 is represented at two
locations as viewed in Fig. 11. In Fig. 11, the cross-
section of groove 68 at the 10 o'clock position (where lines
11-11 are located in Fig. 9) is just distal of the cross-
section of groove 68 shown in phantom at the 12 o'clock
position.
Referring now to Fig. 8 in conjunction with Figs.
9-13, elongated internal cylindrical sleeve 70 is positioned
partially within inner helically grooved sleeve 66 and
collar 60 when collar 60 is in the distalmost position, as
shown in Fig. 8; however, when collar 60 is withdrawn to the
proximalmost position as shown in phantom lines in Fig. 8,
the major portion of internal cylindrical sleeve 70 is
positioned within collar 60 as shown. Internal sleeve 70 is
preferably of nylon (preferably glass filled for strength)
and defines a distal face 72 which is generally oriented at
an acute angle with respect to the longitudinal axis of the
instrument as shown clearly in Figs. 8 and 13. The sleeve
70 contains pin 74 extending radially outwardly from the
outer surface as shown. Pin 74 is preferably of steel or it
may be formed of nylon integral with sleeve 70. Pin 74 is
positioned for slidable movement within the helical groove
68 of inner sleeve 66 of collar 60 such that proximal .
movement of collar GO will cause pin 74 to follow the groove
68 causing sleeve 70 to rotate in one direction. Similarly,
distal movement of collar 60 to the position shown in
phantom lines in Fig. 7 will cause pin 74 to traverse groove
68 in the opposite direction thereby causing sleeve 70 to
rotate in the opposite direction.
CA 02444769 2003-10-29
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1 The significance of the rotational motion of
sleeve 70 as it pertains to the pivotal motion of staple
storing magazine 16 will be described in further detail
hereinbelow. At this stage, however, it is sufficient to
state that the obliquely oriented distal face 72 of sleeve
70 engages the proximal ends of a pair of longitudinally
extending push rods 76,78 shown in phantom lines in Fig. 13
and more clearly in Fig. 14 such that when collar 60 is
moved distally or proximally, inner sleeve 70 also rotates
and the rods 76,78 respectively move in equal and opposite
directions by the engagement with different portions of
oblique distal face 72 with these rods. In essence, one rod
is engaged by a surface portion distal of the surface
portion on the side of face 72 which engages the other rod.
Thus, when the sleeve 70 is rotated in one direction, rod 78
moves in the distal direction while rod 76 withdraws
proximally the same distance, and when sleeve 70 is rotated
in the opposite direction, rod 76 moves in the distal
direction and rod 78 moves proximally the same distance.
Collar 60 contains rotary ridges 60a in the distal
half and longitudinal ridges 60b in the proximal half, and
is thus conveniently movable longitudinally and rotatably by
the user when the appropriate knurled portion is gripped
between the user's fingers. However, the operator need not
grip the collar 22 at any specific locations. The ridges
may be formed integral by molding procedures or
alternatively may be in the form of knurled surfaces. The
rotary ridges respectively permit collar 60 to be finger
movable distally and proximally, while the longitudinal
ridges assist in rotation of collar 60 by hand. Rotational
motion of the collar causes the endoscopic portion 14 to
CA 02444769 2003-10-29
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1 rotate while proximal movement of the collar in a preferred
embodiment causes staple storing magazine 16 to pivot up to
about 45 degrees in one direction with respect to the
longitudinal axis of the instrument as shown in Fig. 1.
Distal movement of the collar 60 to the distalmost position
shown in Fig. 8, causes staple storing magazine 16 to
withdraw to the original orientation shown in Fig. 1 which
is generally in line with the endoscopic section. Thus, by
pivoting the staple storing magazine up to 45 degrees and by
rotating the endoscopic portion 14, the total range of
movement of the staple storing magazine is 45 degrees to
either side of the endoscopic section traversing a total of
90 degrees of effective pivotal movement. With respect to
movements of collar 60, the direction which produces pivotal
motion of staple storage magazine 16 away from the
longitudinal axis or toward the axis is clearly a matter of
choice and would be determined by the respective
configurations of the coacting components.
In the alternative embodiment shown in Fig. lA,
the internal sleeve 70 and forward face 72 are configured
such that collar 22 may be positioned midway between
proximal and distal positions. The mid-position will
correspond to the staple storage magazine being at zero
degrees with respect to the longitudinal axis. Collar
movement in one direction from neutral will produce up to 45
degrees of pivotal movement of magazine 16 and collar
movement in the other direction on the side of neutral will
produce pivotal movement of the magazine 16 up to 45 degrees
in the other direction. A major distinction in this
embodiment is that the actual orientation of the magazine
CA 02444769 2003-10-29
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1 with respect to the longitudinal axis will differ on either
side of neutral.
Referring now to Figs. 15 and 16, the system for
providing pivotal motion to the staple storing magazine 16
is illustrated at the distal end of the instrument. In Fig.
16 the staple storage magazine 16 is shown in the position
generally in alignment with the endoscopic section and is
shown in phantom lines at the pivoted locations
corresponding to plus or minus 45 degrees. The staple
storage magazine is formed of an outer housing of a suitable
plastic material such as polycarbonate and is comprised of
upper housing half section 16a and lower housing half
section 16b attached by welding, adhesives, etc. The upper
housing half section 16a contains an indentation 80 at the
proximal end having a"V-shaped" cross section and the lower
housing half section 16b contains a similar indentation 82
also having a "V-shaped" cross section as shown. Both
indentations 80,82 are adapted to respectively engagably
receive the distal ends of rods 76,78 (which are rounded)
such that when the rods are respectively and alternately
moved in the proximal and distal directions as described
hereinabove, one rod may advance distally to cause the upper
housing to rotate and the other rod withdraws to permit the
pivotal motion of the staple magazine. For example, as
shown in Fig. 16, when rod 78 moves distally, engagement of
the tip of the rod 78 with indentation 80 in upper housing
16a of staple storing magazine causes the staple magazine to
pivot downwardly as shown in phantom.
Similarly, equal and oppositely withdrawing rod 76
will accommodate the downward movement of the staple storing
magazine 16. In a similar fashion when the collar 60 is
CA 02444769 2003-10-29
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moved in the opposite distal direction the movement of each
rod is respectively reversed causing rod 76 to move distally
and to engage the lower housing 16b of staple storing
magazine 16 and rod 78 withdraws to accommodate the pivotal
movement of staple storing magazine back to the original (or
neutral) position in general alignment with the endoscopic
section as shown in Fig. 16. The lost motion connector 30
clearly provides a minor degree of space (i.e.. about 1/10
inch) between the components, which space provides the
advantages mentioned previously.
Alternatively one rod may be provided and
connected to the staple storage magazine and adapted to
pivot the magazine by causing such rod to move proximally
and distally thereby actually pivoting the magazine about
the pivot point.
The endoscopic section 14 is shown clearly in Fig.
14 and is mounted for rotation relative to the handle
section 18. As noted above, the endoscopic section may be
permanently attached to handle 12 as shown in a disposable
instrument; alternatively as noted above, it may be
removably attached to a re-usable handle, or a variety of
other combinations or configurations.
THE Er1DOSCOPIC SECTION
Referring again to Fig. 14 the endoscopic section
is shown in exploded view with parts separated for
convenience of illustration and includes upper housing half
section 14a and lower housing half section 14b. The housing
half sections are preferably of a polycarbonate material
such as *LEXAN brand material mentioned previously, and are
attached by welding, adhesives, etc. Positioned within the
upper and lower housing half sections is pusher assembly 24
*Trade-mark
CA 02444769 2003-10-29
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1 as described in morc detail below, and anvil extension 88,
formed of stainless steel and having a pair of elongated
legs 90,92 which are joined at 94 at the distal end and
which contain upwardly cxtending feet 88a,88b at the
proximal end. As shown in Fig. 15, anvil extension 88 is
attached at the distal end' 94 to the staple storing magazine
16 by pivot pins 89 where the staple storing magazine is
pivotally attached. The proximal connection points of anvil
extension are best illustrated in Fig. 2 wherein upwardly
bent feet 88a,88b are positioned within slots 15b in half
round collar 15 which is fixedly attached to handle housing
12 by barrel 17 and nose piece 13 and related support
members provided therein.
Anvil extension 88 is fabricated of stainless
steel and its purpose is to stabilize the dimension of the
endoscopic section 14 to prevent the forces acting on the
components from stretching or compressing the upper and
lower housing half sections 14a,14b of the endoscopic
section which are constructed of a polycarbonate material
such as *LEXAN brand material. Thus, the steel anvil
extension provides dimensional stability to the endoscopic
section while the endoscopic section is supporting the
components being subjected to forces for supporting,
advancing and forming the surgical staples as will be
described.
THE STAPLE FIRING SYSTEM
Referring further to Fig. 14, the steel pusher
assembly 24 is formed of firing rod 100 connected to
flexible elongated firing wire 102 which is in turn
connected to pusher plate assembly 104 as shown. The
*Trade-mark
CA 02444769 2003-10-29
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1 connection between firing rod 23 and firing wire 102 is a
crimped or swaged connection at 106, whereas the connection
between firing wire 102 and pusher 105 is accomplished by an
interference fit between the firing wire 102 and collar 108
5* which is attached to pusher plate 104. Firing rod 28 and
pusher plate 104 are preferably made of stainless steel
whereas firing wire 102 is made to be resiliently flexible
to accommodate the pivotal movement of the staple storing
magazine 16 since firing wire 102 is located within the
instrument at the location of staple magazine 16. In
particular, firing wire 102 is preferably made of a super
elastic metal. One example of such super elastic metal is
*NITINOL brand metal available from Raychem Corporation,
Menlo Park, California. This material has a reduced
tendency to fatigue after a substantial number of cycles of
deflection caused by pivoting the staple storage magazine.
Other resilient materials are also contemplated for firing
wire 102.
THE STAPLE STORAGE MAGAZIrlE
Referring now to Figs. 15 through 18, there is
illustrated further details of the staple storing magazine
16. As noted previously, the staple storing magazine 16 is
comprised of upper housing half 16a and lower housing half
16b suitably attached by welding,adhesives, etc. The
magazine is adapted to contain a plurality of surgical
,staples 110 which are particularly shaped to penetrate and
to attach surgical mesh to body tissue. For particular
details of the shape of the staples constructed according to
the invention, reference is made to Fig. 28.
*Trade-mark
CA 02444769 2003-10-29
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1 Referring once again to Figs. 15-18, a particular
feature of the present invention resides in the system of
storage of the staples 110 which are positioned in adjacent
stacked relation whereby the stack of staples forms an angle
with the longitudinal axis of the instrument of
approximately 45 degrees as shown in Fig. 18. One purpose
of stacking the staples as shown is to provide greater
visibility to the user by the fact that the outer surface of
the upper housing half section adjacent the stack of staples
forms a similar angle and provides visibility to the user at
the distal end of the staple storage magazine. Angular
stacking of the staples as shown greatly facilitates storage
of a plurality of staples in a structure configured and
dimensioned for use in endoscopic applications, e.g., for
use through a trocar guide tube of diameter of about 12 ml'n
for example. The stack of staples 110 i as shown in Fig. 18
is positioned and retained in such position by a resilient
spring member 113 having dual resilient legs and whose side
profile is curved as shown in Fig. 18.
. The distal end of each leg engages the uppermost
staple follower 114 in the form of a nylon insert having a
general "H-shaped" configuration and dimensioned sufficient
to cover the staples as best shown in Fig. 15. The nylon
follower is intended to transmit the downward force of the
staple retainer spring 113 so as to distribute the force, on
the stack of staples in a manner to facilitate a constant
and uni-directional downward force on the lowermost staple
which is positioned for advancement and deformation. It
also functions to advance the stack of staples downwardly
when the lowermost staple is fired. Steel anvil plate 120
is shown in Fig. 15 and includes upwardly extending feet 116
CA 02444769 2003-10-29
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1 and 118 which form anvils at the distal end as shown in Fig.
15, for forming the staple therearound.
Thus, as seen in Fig. 18, the lowermost staple is
identified by numeral 110L and is in a position for
engagement by pusher plate 104 when the pusher assembly is
advanced distally. The pusher plate 104 is shown clearly in
Figs. 15 and 18 and contains distally advancing lands 104R
and 104L shown clearly in Figs. 15 and 19 at the distal end
to facilitate transmission of advancing force to the two
rounded or arcuate bridge portions of the staple. This
relative complementary configuration of the pusher plate 104
and the staple 110 facilitates efficient and uniform
distribution of force to the staple when it is deformed
about the anvil members as will be described.
THE STAPLE CLOSING SYSTEM
Referring now to Figs. 17-24 there is illustrated
the sequential views of the staple advancing and closing
system between the pre-fired and fired condition of the
staple. In particular, the staple and pusher mechanism are
shown in Fig. 17 in the pre-fired condition while the staple
shown in Fig. 24 is embedded within the body tissue in a
manner to retain the surgical mesh to the body tissue.
In Fig. 17, the staple pusher assembly 24 is
positioned proximal of the lowermost staple 110L and pusher
plate 104 is correspondingly positioned proximal of the -
lowermost staple 110L. In Figs. 18 and 19 the pusher plate
104 has been partially advanced distally and the lowermost
staple 110L has been advanced distally of the stack of
staples 110 in a manner such that the pusher plate 104 has
now replaced lowermost staple 110L thereby preserving the
CA 02444769 2003-10-29
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1 integrity and position of the stack of staples 110. The
preservation of the stack of staples 110 is provided by the
fact that the thickness of the staple pusher plate 104 is
either identical to or slightly less than the thickness of
the staples to assume that the plate 104 will engage only
one staple at a time.
Referring further to Figs. 20 and 21 the pusher
plate 104 has now advanced distally sufficient to cause the
staple to penetrate the surgical mesh 112 and the body
tissue 114. As shown in Figs. 20 and 21, it can be seen
that anvil members 116 and 118 are positioned for engagement
by the straight sections of bridge portions 110BR and 110BL
of the back rib of the staple ilOL such that engagement of
the staple by pusher plate 104 with the arcuate end corner
portions of the staple as shown will cause the staple to
deform in a predetermined manner as will be described.
In Figs. 22-24 the staple 110L is now shown in the
deformed condition about the anvil members 116 and 118 and
the straight portions 110S of the back rib of the staple 110
are still in engagement with the anvils 116,118. In Fig.
22, the staple has penetrated into the body tissue 114 and
has been deformed and in Fig. 24 the staple deformation is
completed in a manner to substantially retain the surgical
mesh 112 in attached position with respect to the body
tissue as shown in Fig. 22. The inwardly projecting central
portion or bight, 110C, of staple 110 is shown gripping the
mesh and tissue in cooperation with the staple legs as shown
in Fig. 24. However, release of the staples from the anvil
members 116,118 has not yet been completed.
( 30 Release of the staple from the anvil members
I 116,118 is readily accomplished by ejector spring 124 which
CA 02444769 2003-10-29
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1 is a "U-shaped" resilient spring having upwardly biased legs
124R and 124L each positioned respectively as shown in Fig.
15. When the pusher plate 104 is in the position shown in
Fig. 20, the legs 124R and 124L of staple ejector spring are
retained in a downward position by lands 104R and 104L of
the pusher plate 104. However, when the pusher plate 104 is
moved to the distalmost position shown in Fig. 23, the
absence of the pusher plate permits staple ejector legs 124R
and 124L to resiliently deflect upwardly to their natural
configuration thereby creating a vertical separation between
the anvil members 116,118 and the deformed staple, thus
releasing the deformed staple from the anvil members as
shown in Fig. 23. Continued proximal movement of the pusher
plate 104 causes withdrawal of the pusher plate to a
position entirely proximal of the stack of staples 110 as
shown in Fig. 26, causing the stack of staples to move
downwardly due to the downward force of resilient staple
retainer spring 113 to advance the lowermost staple to the
firing position.
Once the staple 110 is applied to the mesh 112 and
tissue 114 as shown in Figs. 22 and 24, the distal end of
staple storing magazine 16 is withdrawn as shown in Fig. 24
and preparation is made for application of the next staple.
Fig. 25 is a cross-sectional view taken along lines 25-25 of
Fig. 24 with the staple storing magazine withdrawn from the
surgical mesh and body tissue. Thereafter, the apparatus
may be repositioned to apply another staple, or even an
array of staples as shown in Figs. 27 and 29.
Referring once again to Fig. 27, there is
illustrated one form of surgical mesh repair of an opening
in the body utilizing the apparatus and staple according to
CA 02444769 2003-10-29
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1 the invention. In the application shown in Fig. 27, a
surgical mesh is attached to the body tissue over the
opening as illustrated schematically at 114c in Fig. 27, and
staples 110 have been applied in a circular array as shown
to reinforce the repair. Beneath the mesh, the opening 114c
may have previously been repaired as well. In Fig. 29 an
alternative array of staples to apply mesh material to body
tissue is shown. In this embodiment the mesh material 112
is essentially formed as a circular patch and staples 110
are oriented in a radial direction and are attached around
the periphery of the patch such that one leg of the staple
pierces the mesh and the other leg pierces body tissue 114.
Essentially the staple bridges the periphery of the mesh
material as shown. Clearly, alternative forms and
arrangements are available to attach mesh or other surgery
related objects or prostheses to body tissue as may come to
the mind of persons skilled in the art.
It should be further noted that the repair of body
tissue utilizing surgical mesh as shown in Figs. 27 and 29
are exemplary, and that other applications of mesh and
staples may be utilized in a man~ier to either reinforce a
surgical repair or to encourage tissue growth. Such mesh
materials are typically disclosed in U.S. Patent Nos.
4,838,884, 4,665,221, 4,452,245, and 4,347,847. It is noted
that the staple constructed according to the invention as
shown in Fig. 28 is particularly adapted for attachment of
such mesh material to body tissue according to any number of
techniques which may readily come to the mind of those
skilled in the art. In fact, in some instances the mesh may
be formed as a plug for insertion into a surgical opening
and then stapled. Moreover, the apparatus and staple of the
CA 02444769 2003-10-29
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I present invention may be applied to attach other objects to
body tissue as may come to the mind of those skilled in the
art.
THE STAPLE
Referring now once again to Fig. 28, there is
illustrated the inventive staple 110 constructed according
to the invention. The staple 110 is particularly shaped as
shown, and is preferably formed of a length of wire of
titanium. Stainless steel or equivalent material is also
contemplated and the staple preferably has a rectangular
cross-section as shown. Other cross-sections may be used.
Typically, the wire will be about .38mm in width (dimension
w) and .51 mm in thickness (dimension T). The initial width
of the staple before closure (dimension A) is about 4.4mm
and the thickness dimension between the back rib and legs
after closure (i.e. dimension B in Fig. 24) is about 3mm.
The staple 110 has a central bight portion 110C and a wire
leg member 110R and 110L extending generally perpendicular
to the central portion as shown. Each leg member 110R, 110L
is connected to the central portion 110C by a bridge portion
110BR, 110BL having an arcuate corner portion as shown.
Each leg member has a sharp tip for penetrating mesh and
body tissue. Right lecJ member 11OR further possesses a
tapered surface 110TR at the tip which is opposite the
position of the tapered surface 11OTL at the tip of the
other leg member 110L ao shown in Fig. 28.
When the staple shown in Fig. 28 is advanced
toward dual spaced anvils 116,118 as shown in Fig. 21 for
example, and staple pu~:;her plate 104 as shown, engages the
arcuate portions of the bridge portions 110BR and 110BL, the
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1 legs of the staples are made to fold inwardly toward each
other as shown for example in Fig. 22, with one leg crossing
over the other. The cross-over configuration is
automatically assumed by the legs because of the presence of
tapered surfaces 110TR and 11OTL which act as camming
surfaces tending to bias each leg away from the other
thereby tending to cross the legs in the manner shown. This
structure also prevents interference of the legs when folded
toward each other.
Thus, it can be seen that the particular shape of
the staple as shown, promotes a unique folding pattern for
the legs which achieveo the configuration shown in the bent
staples of Figs. 22 and 24. Note in particular that
inwardly bent central portion 110C promotes positive
attachment of the mesh to the tissue by providing a gripping
system between inwardly projecting bight portion 110C and
leg members 11OR and 110L with mesh and tissue gripped
therebetween. This staple shape combines with the
arrangement of the anvils and the particularly configured
pusher plate 104 to cause the staple to pierce mesh and body
tissue up to a predetermined extent. At this point,
continued application of force to the staple causes the
staple legs to fold upon themselves as shown in the drawings
while encompassing a sufficient portion of the mesh to
attach the mesh to the body tissue. Thus the staple pieces
folds and grips in substuntially a single movement.
In practice, the laparoscopic procedures to repair
tissue in hernia repair using surgical mesh is similar in
some respects to the surgical procedures to gall bladders,
appendix, lungs, etc. In particular, the endoscopic tubular
section of the apparatus is inserted into the cannula which
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1 is positioned within the opening in the body. Provision is
made between the cannula and the endoscopic section to seal
the connection therebetween and provision may also be
provided to seal the actual endoscopic apparatus from
leakage of fluids or insufflating gaseous media. An
exemplary cannula assembly including seal means is disclosed
for example in commonly assigned U.S. Patent No. 4,943,280,
issued July 24, 1990.
THE KIT
The present invention is readily adaptable to be
provided to surgeons in the form of a kit in which all
necessary equipment and accessories are provided in sterile
form ready for use in surgery. For example, an apparatus
constructed according to the invention can be readily
packaged with a supply of staples (i.e. up to 12 or more
staples) and sufficient mesh material for completing the
hernial repair. The mesh material is typically about 1 mm
in thickness. The components may be provided separately as
a matched kit, or in a blister type or other package,
suitable and ready for use by the surgeon and the surgeon's
assistants. The apparatus and staples can be provided in
any size matched to meet the apparatus and mesh material in
accordance with the particular needs of a contemplated
hernial surgical procedure. In addition, the kit can
include a matching trocar assembly with appropriate valve
assembly to prevent loss of the insufflating gas from the
peritoneum between the trocar and the outside surface of the
endoscopic section. Since the outer housing of the
endoscopic section is substantially closed at the point of
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1 attachment of the staple magazine, release of insufflating
gases through the staple magazine and the endoscopic section
housing is either non existent or minimal. Such trocar
assembly is available from United States Surgical
Corporation, Norwalk, Connecticut, under the trademark
SURGIPORT brand trocar assembly.
A typical endoscopic section may be a 12mm
diameter with a staple niagazine capable of holding up to 10
staples of appropriate size. The length of the endoscopic
section is typically 14 to 15 inches. An endoscopic section
in the embodiment shown will be about 14 inches. However,
if pivotal movement of the staple storage magazine is to be
provided between plus 45 degrees and minus 45 degrees solely
by distal and proximal movement of collar 22, the endoscopic
section will be structured to greater in length, i.e. about
15 inches. The trocar assembly will be of matching size,
i.e., 12mm, to accommoda-%e the endoscopic section and to
prevent release of gases thereby. The mesh material
provided with the kit will be of mesh size comparable for
use with the size of the staples provided in the kit.
Thus by structuring the apparatus to provide such
sealing, the endoscopic application of staples to attach
objects such as surgical mesh to body tissue can be readily
accomplished. Accordingly, the present invention is not
only directed to the apparatus for applying such staples to
body tissue, but also to a kit in which the apparatus is
uniquely combined with a supply of staples, surgical mesh,
cannula assembly etc. whereby the surgeon may readily
perform the necessary procedures.
35
