Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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SURGICAL STAPLING APPARATUS WITH LOCKING MECHANISM
BACKGROUND
1. Technical Field
The present disclosure relates to a surgical apparatus, e.g., a surgical
stapling
apparatus. More particularly, the present disclosure relates to an endoscopic
surgical
stapling apparatus that includes a locking mechanism for retaining the drive
assembly of
a loading unit, e.g., a single use loading unit ("SULU") or disposable loading
unit
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("DLU"), at a substantially fixed axial position until the SULU or DLU has
been loaded
with or secured to a surgical stapling apparatus, to ensure proper or complete
engagement
of the SULU or DLU, especially its drive assembly, to the surgical stapling
apparatus.
For simplicity, hereinafter, SULU or DLU will be referred to as "DLU", but it
should be
understood to include either or both a DLU or SULU.
2. Background of Related Art
Surgical devices wherein tissue is first grasped or clamped between opposing
jaw
structure and then joined by surgical fasteners are well known in the art. In
some
instruments a knife is provided to cut the tissue which has been joined by the
fasteners.
The fasteners are typically in the form of surgical staples but two part
polymeric fasteners
can also be utilized.
Instruments for this purpose can include two elongated jaw members which are
respectively used to capture or clamp tissue. Typically, one of the jaw
members carries a
staple cartridge which houses a plurality of staples arranged in at least two
lateral rows
while the other jaw member has an anvil that defines a surface for forming the
staple legs
as the staples are driven from the staple cartridge. Generally, the stapling
operation is
effected by cam members that travel longitudinally through the staple
cartridge, with the
cam members acting upon staple pushers to sequentially eject the staples from
the staple
cartridge. A knife can travel between the staple rows to longitudinally cut
and/or open
the stapled tissue between the rows of staples. Such instruments are
disclosed, for
example, in U.S. Pat. No. 3,079,606 and U.S. Pat. No. 3,490,675.
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A later stapler disclosed in U.S. Pat. No. 3,499,591 also applies a double row
of
staples on each side of the incision. This patent discloses a surgical stapler
that has a
disposable loading unit in which a cam member moves through an elongate guide
path
between two sets of staggered staple carrying grooves. Staple drive members
are located
within the grooves and are positioned in such a manner so as to be contacted
by the
longitudinally moving cam member to effect ejection of the staples from the
staple
cartridge of the disposable loading unit. Other examples of such staplers are
disclosed in
U.S. Pat. Nos. 4,429,695 and 5,065,929.
Each of the instruments described above is designed for use in conventional
surgical procedures wherein surgeons have direct manual access to the
operative site.
However, in endoscopic or laparoscopic procedures, surgery is performed
through a
small incision or through a narrow cannula inserted through small entrance
wounds in the
skin. In order to address the specific needs of endoscopic and/or laparoscopic
surgical
procedures, endoscopic surgical stapling devices have been developed and are
disclosed
in, for example, U.S. Pat. No. 5,040,715 (Green, et al.); U.S. Pat. No.
5,307,976 (Olson,
et al.); U.S. Pat. No. 5,312,023 (Green, et al.); U.S. Pat. No. 5,318,221
(Green, et al.);
U.S. Pat. No. 5,326,013 (Green, et al.); U.S. Pat. No. 5,332,142 (Robinson, et
al.); and
U.S. Pat. No. 6,241,139 (Milliman et al.).
Tyco Healthcare Group, LP, the assignee of the present application, has
manufactured and marketed endoscopic stapling instruments, such as the
Multifire
ENDO GIATm 30 and Multifire ENDO GIATm 60 instruments, for a number of years.
These instruments include a surgical stapling apparatus and a DLU. Typically,
the DLU
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is attached to the apparatus immediately prior to surgery. After use, the DLU
can be
removed from the apparatus and a new DLU can be fastened to the apparatus to
perform
additional stapling and/or cutting operations.
These instruments have provided
significant clinical benefits. Nonetheless, improvements to these instruments
are still
possible.
It would be desirable to provide an improved DLU for a surgical stapling
apparatus and an improved surgical stapling apparatus having the DLU loaded
thereon.
It would also be desirable to provide a locking member for a DLU to assure
proper loading of the DLU to the shaft of a surgical stapling apparatus.
Accordingly, it is an object of this disclosure to provide an improved DLU
which
locks or retains its drive assembly in proper position to be loaded onto the
shaft of a
surgical stapling apparatus (hereinafter referred to as the or a "ready-to-
load position")
until the DLU is loaded onto a surgical stapling apparatus to assure that when
the DLU is
loaded thereto, the drive assembly is properly engaged by, coupled to or
connected to a
drive member of the shaft, thereby helping to ensure proper operation of the
DLU and the
surgical stapling apparatus. For example, with the DLU loaded onto the
surgical stapling
apparatus, after firing of the surgical stapling apparatus, retraction of the
control rod will
unapproximate or open and/or unclamp the anvil and cartridge assemblies.
An object of the disclosure is to provide an improved DLU that includes a
locking
mechanism that retains the drive assembly in such a ready-to-load position
until the DLU
is loaded onto the surgical stapling apparatus.
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Another object of the disclosure is to provide such a locking mechanism for a
DLU.
Another object of the present disclosure is to provide a locking mechanism for
a
DLU and a DLU having a locking mechanism, such that firing of the surgical
stapling
apparatus is prevented unless and until the DLU is loaded onto the shaft of
the surgical
stapling apparatus.
Yet another object of the disclosure is to provide a DLU that, after firing,
can be
disconnected from the surgical stapling apparatus.
Yet another object of the disclosure is to provide a DLU that has only two
conditions, one in which it is not loaded and its drive assembly is locked or
retained in
the ready-to-load position, and another in which the DLU is loaded onto the
shaft of a
surgical stapling apparatus and in which the drive assembly is unlocked and
free to be
actuated.
Still another object of the present disclosure is to provide the above objects
in a
roticulating, i.e., roticulable, DLU.
SUMMARY
In accordance with the present disclosure, a surgical apparatus, e.g., a
surgical
stapling apparatus and/or a loading unit for use with the surgical apparatus,
including a
locking mechanism for ensuring proper engagement of a disposable loading unit
to an
end of the surgical apparatus is provided. According to one aspect of the
present
disclosure the surgical apparatus comprises a housing including an elongate
body
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extending therefrom; and a loading unit supportable on a distal end of the
housing. The
loading unit includes a housing portion including a distal end and a proximal
end; a drive
assembly slidably supported within the housing portion of the loading unit;
and a locking
mechanism pivotally supported on the housing portion of the loading unit. The
locking
mechanism has a first position wherein the locking mechanism engages a portion
of the
drive assembly and maintains the position of the drive assembly relative to
the housing
portion of the loading unit. The locking mechanism has a second position
wherein the
locking mechanism disengages the drive assembly and enables the drive assembly
to
move relative to the housing portion. The locking mechanism is configured for
movement from the first position to the second position in response to a
connection of the
loading unit to the elongate body of the housing.
According to another aspect of the present disclosure the loading unit for use
with
and/or supportable on a distal end of an elongate body of a surgical stapling
apparatus,
comprises a housing portion including a distal end and an elongate body
extending from
the distal end thereof; a drive assembly slidably supported within the housing
portion of
the loading unit; and a locking mechanism pivotally supported on the housing
portion of
the loading unit. The locking mechanism has a first position wherein the
locking
mechanism engages a portion of the drive assembly and maintains the position
of the
drive assembly relative to the housing portion of the loading unit. The
locking
mechanism has a second position wherein the locking mechanism disengages the
drive
assembly and enables the drive assembly to move relative to the housing
portion. The
locking mechanism is configured for actuation from the first position to the
second
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position in response to a connection of the loading unit to the elongate body
of the
surgical stapling apparatus.
In one embodiment, the locking mechanism may include a lever pivotably
connected to the housing portion and defining a pivot point, the lever having
a distal end
extending distally of the pivot point and a proximal end extending proximally
of the pivot
point, the distal end of the lever including a hook formed therein for
selectively engaging
a portion of the drive assembly, wherein when the locking mechanism is in the
first
position the hook engages the portion of the drive assembly and when the
locking
mechanism is in the second position the hook is disengaged from the portion of
the drive
assembly.
When the locking mechanism is moved from the first position to the second
position, the proximal end of the lever may be moved radially inward relative
to a central
longitudinal axis of the loading unit and the distal end of the lever is moved
radially
outward relative to the central longitudinal axis of the loading unit. The
locking
mechanism may be moved from the first position to the second position upon a
coupling
of the loading unit to a distal end of the elongate body.
The loading unit and the elongate body may be configured for twisting
engagement with one another, wherein the locking mechanism is moved from the
first
position to the second position by a twisting action of the loading unit
relative to the
elongate body when the proximal end of the housing portion of the loading unit
is
inserted in to the distal end of the elongate body.
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The locking mechanism may further include a biasing member operatively
associated therewith. The biasing member may bias the lever to the first
position.
When the locking mechanism is in the first position, the proximal end of the
lever
may extend radially beyond an outer surface of the housing portion. The
proximal end of
the lever of the locking mechanism may define an angled surface to facilitate
connection
with the elongate body.
The surgical apparatus may further include an elongate body extending from the
housing. The elongate body may include a distal end configured and dimensioned
to
selectively receive the proximal end of the housing portion of the loading
unit.
In another embodiment, the locking mechanism may include a lever having a
distal end pivotably connected to the housing portion and a free proximal end;
and a tooth
extending radially inward from the lever, wherein the tooth selectively
engages an
engagement surface formed on the drive assembly such that when the locking
mechanism
is in the first position the tooth engages the engagement surface of the drive
assembly and
when the locking mechanism is in the second position the tooth is disengaged
from the
engagement surface of the drive assembly.
Accordingly, when the locking mechanism is moved from the first position to
the
second position, the lever may be pivoted about the distal end thereof such
that a
longitudinal axis of the lever is angled with respect to a longitudinal axis
of the housing
portion.
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The locking mechanism may be moved from the first position to the second
position by a projection extending radially inward of the elongate body. The
projection
may act on a side surface of the lever as the loading unit is twisted into
loaded
engagement in the elongate body.
When the locking mechanism is in the first position the lever may be
substantially
axially aligned with a nub extending radially outward from the proximal end of
the
housing portion and when the locking mechanism is in the second position the
lever is
out of axial alignment with the nub of the insertion tip.
The proximal end of the lever may include a nub extending toward the proximal
end of the housing portion, and wherein the proximal end of the housing
portion may
include a recess formed in the surface thereof for receipt of the nub of the
lever when the
lever is in the first position.
The locking mechanism may further include a biasing member operatively
associated therewith for maintaining the lever in the first position.
The surgical apparatus may be a stapler. The surgical apparatus may include an
elongate body extending from the housing. The proximal end of the housing
portion of
the loading unit may define an insertion tip.
Additional advantages will become apparent from the description which follows,
taken in conjunction with the accompanying drawings.
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BRIEF DESCRIPTION OF THE DRAWINGS
The present disclosure will be further described with reference to the
accompanying drawings, wherein like reference numerals refer to like parts in
the several
views, and wherein:
FIG. 1 is a top perspective view of a preferred embodiment of the presently
disclosed surgical stapling apparatus;
FIG. 2 is a top view of the surgical stapling apparatus shown in FIG. 1;
FIG. 3 is a side view of the surgical stapling apparatus shown in FIGS. 1 and
2;
FIG. 4 is a top perspective view of the surgical stapling apparatus of FIGS. 1-
3
with the DLU disengaged from the elongate body of the surgical stapling
apparatus;
FIG. 5 is a bottom perspective view of a non-articulating DLU for use with the
surgical stapling apparatus of FIGS. 1-4;
FIG. 6 is a bottom perspective view of the preferred articulating DLU of the
surgical stapling apparatus of FIGS. 1-4;
FIG. 7 is a top perspective view of the DLU of FIG. 6;
FIG. 8 is a top perspective view of the DLU of FIGS. 6 and 7;
FIG. 9 is a top perspective view, with parts separated, of the proximal
housing
portion and mounting assembly of the DLU of FIGS. 6-8;
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FIG. 10 is an enlarged top perspective view, with parts separated, of a
proximal
portion of the upper housing half of the DLU of FIGS. 6-9;
FIG. 11 is a top perspective view of the proximal housing portion and mounting
assembly of the DLU of FIGS. 6-9 with the upper half of housing portion
removed;
FIG. 12 is a top perspective view, with parts separated, of a portion of the
axial
drive assembly of the DLU of FIGS. 6-9;
FIG. 13 is a top perspective view of the portion of the axial drive assembly
of
FIG. 11 of the DLU of FIGS. 6-9;
FIG. 14 is an enlarged top perspective view of a lower housing half of the
housing
portion of the DLU of FIGS. 6-9;
FIG. 15 is an enlarged perspective view of the distal end of the elongated
body of
the stapling apparatus shown in FIGS. 1-4, shown with the control rod
extending
therethrough;
FIG. 15a is an enlarged perspective view of the distal end of the elongate
body of
FIG. 15, shown without the control rod extending therethrough;
FIG. 16 is an enlarged perspective view of the proximal end of the DLU of
FIGS.
6-9 illustrating a locking mechanism according to the present disclosure;
FIG. 17 is an enlarged top plan view with portions broken away illustrating a
stage in the attachment of the DLU of FIGS. 6-9 to the elongate body of the
surgical
stapling apparatus shown in FIGS. 1-3;
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FIG. 18 is an enlarged top plan view with portions broken away illustrating
another stage in the attachment of the DLU of FIGS. 6-9 to the elongate body
of the
surgical stapling apparatus shown in FIGS. 1-3;
FIG. 19 is an enlarged top plan view with portions broken away illustrating
yet
another stage in the attachment of the DLU of FIGS. 6-9 to the elongate body
of the
surgical stapling apparatus shown in FIGS. 1-3;
FIG. 20 is a longitudinal cross-sectional view of the proximal end of the DLU
of
FIGS. 6-9 as taken along line 20 - 20 of FIG. 16;
FIG. 21 is an enlarged transverse cross-sectional view of the proximal end of
the
DLU of FIGS. 6-9 with the distal end of the elongate body on the proximal end
of the
DLU as would be taken along 21 - 21 of FIG. 16, illustrating the locking
mechanism in
the first position;
FIG. 22 is an enlarged transverse cross-sectional view of the proximal end of
the
DLU of FIGS. 6-9 with the distal end of the elongate body on the proximal end
of the
DLU as would be taken along 21 - 21 of FIG. 16, illustrating the locking
mechanism in
the second position;
FIG. 23 is a top perspective view of a surgical stapling apparatus according
to a
further embodiment of the present disclosure;
FIG. 24 is a top view of the surgical stapling apparatus shown in FIG. 23;
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FIG. 25 is a side view of the surgical stapling apparatus shown in FIGS. 23
and
24;
FIG. 26 is a top perspective view of the surgical stapling apparatus of FIGS.
23-
25 with a DLU disengaged from the elongate body of the surgical stapling
apparatus;
FIG. 27 is a bottom perspective view of a non-articulating DLU for use with
the
surgical stapling apparatus of FIGS. 23-26;
FIG. 28 is a bottom perspective view of the preferred articulating DLU of the
surgical stapling apparatus of FIGS. 23-26;
FIG. 29 is a top perspective view of the DLU of FIG. 28;
FIG. 30 is a top perspective view of the DLU of FIGS. 28 and 29;
FIG. 31 is an enlarged top perspective view, with parts separated, of the
proximal
housing portion and mounting assembly of the DLU of FIGS. 28-30;
FIG. 31a is an enlarged top perspective view of the proximal portion of the
upper
housing half of the DLU of FIGS. 28-31;
FIG. 32 is a top perspective view of the proximal housing portion and mounting
assembly of the DLU of FIGS. 28-31 with the upper housing half removed;
FIG. 33 is a top perspective view, with parts separated, of the axial drive
assembly of the DLU of FIGS. 28-31;
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FIG. 34 is a top perspective view of the axial drive assembly of FIG. 33 of
the
DLU of FIGS. 28-31;
FIG. 35 is an enlarged top perspective view of a lower housing half of the
proximal housing portion of the DLU of FIGS. 28-31;
FIG. 36 is an enlarged perspective view of the distal end of the elongated
body of
the stapling apparatus shown in FIG. 26;
FIG. 37 is an enlarged perspective view of the proximal end of the DLU of
FIGS.
28-31 illustrating a locking mechanism according to the present disclosure;
FIG. 38 is an enlarged perspective view of a distal end of the elongate body
of the
stapling apparatus in accordance with the present disclosure;
FIG. 39 is an enlarged perspective view, partially broken-away, of the
proximal
end of the DLU of FIG. 37 illustrating the locking mechanism in a first
position;
FIG. 40 is a longitudinal cross-sectional view of the proximal end of the DLU
of
FIGS. 28-31, as taken through 40 - 40 of FIG. 37, with the locking mechanism
in a first
position;
FIG. 41 is an enlarged perspective view, partially broken-away, of the
proximal
end of the DLU of FIG. 37 illustrating the locking mechanism in a second
position;
FIG. 42 is a longitudinal cross-sectional view of the proximal end of the DLU
of
FIGS. 28-31 as taken through 40 - 40 of FIG. 37, with the locking mechanism in
a second
position;
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FIG. 43 is an enlarged transverse cross-sectional view of the proximal end of
the
DLU of FIGS. 28-31, as taken through 43 - 43 of FIG. 40;
FIG. 44 is an enlarged transverse cross-sectional view of the proximal end of
the
DLU of FIGS. 28-31, as taken through 44 - 44 of FIG. 42, illustrating the
position of the
locking mechanism prior to the rotation of the DLU relative to the elongate
body; and
FIG. 45 is an enlarged transverse cross-sectional view of the proximal end of
the
DLU of FIGS. 28-31, as would be taken through 44 - 44 of FIG. 42, illustrating
the
position of the locking mechanism following rotation of the DLU relative to
the elongate
body.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Preferred embodiments of the presently disclosed surgical apparatus, DLU and
locking mechanism or member will now be described in detail with reference to
the
drawings, in which like reference numerals designate identical or
corresponding elements
in each of the several views.
In the drawings and in the description that follows, the term "proximal", as
is
traditional, will refer to the end of the stapling apparatus which is closest
to the operator,
while the term "distal" will refer to the end of the apparatus which is
furthest from the
operator.
FIGS. 1-4 show a surgical apparatus, e.g., surgical stapling apparatus,
generally
referred to as 10. In the interest of brevity, this disclosure will focus
primarily on
systems, methods and structures for loading, engaging, coupling or connecting
a
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disposable loading unit ("DLU") 16 to surgical stapling apparatus 10. A
detailed
discussion of the remaining components and method of use of surgical stapling
apparatus
10, is disclosed in U.S. Patent 6,241,139.
Surgical stapling apparatus 10 is an endoscopic apparatus and includes a
handle
assembly 12 and an elongated body 14 extending from handle assembly 12. A DLU
16 is
releasably secured to the distal end of elongated body 14. While this
disclosure relates to
the use of a DLU with surgical stapling apparatus 10, it is understood and
within the
scope of the present disclosure that a single use loading unit (SULU) or other
end effector
and/or tool assembly can equally be used in cooperation with surgical stapling
apparatus
10.
DLU 16 includes a tool assembly 17 having a cartridge assembly 18 housing a
plurality of surgical staples (not shown) and an anvil assembly 20 movably
secured in
relation to cartridge assembly 18. As shown herein, DLU 16 is configured to
apply six
(6) linear rows of staples, each row in the DLU's measuring from about 30 mm
to about
60 mm in length. DLUs for applying any number of rows of staples, having
staple
pockets arranged in various patterns and/or DLUs and end effectors having any
other
lengths, e.g., 45 mm, are also envisioned. Handle assembly 12 includes a
stationary
handle member 22, a movable handle member 24, and a barrel portion 26.
A rotatable member 28 preferably is mounted on the forward end of barrel
portion
26 to facilitate rotation of elongated body 14 and attached DLU 16 with
respect to handle
assembly 12. An articulation lever 30 preferably is also mounted on the
forward end of
barrel portion 26 adjacent rotatable member 28 to facilitate articulation of
tool assembly
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17. Preferably, a pair of knobs 32 are movably positioned along barrel portion
26.
Knobs 32 are advanced distally to approximate or close cartridge and/or anvil
assembly
18, 20, and retracted proximally to unapproximate or open cartridge and/or
anvil
assembly 18, 20.
As seen in FIG. 4, DLU 16 is desirably selectively removably couplable to
elongated body 14. DLU 16 includes a housing portion 200 having a proximal end
adapted to releasably engage the distal end of elongated body 14. A mounting
assembly
202 is pivotally secured at 203 to the distal end of housing portion 200, and
is configured
to receive the proximal end of tool assembly 17 such that pivotal movement of
mounting
assembly 202 about an axis at 203 perpendicular to the longitudinal axis of
housing
portion 200 effects articulation of tool assembly 17.
FIGS. 5-8 show various perspective views of DLU 16. Surgical stapling
apparatus 10 is capable of receiving a non-articulating DLU 16a, as seen in
FIG. 5, or an
articulating DLU 16, as seen in FIGS. 6-8. U.S. Patent 6,241,139 includes a
detailed
discussion of articulating and non-articulating DLU.
With reference to FIGS. 9-14, DLU 16 includes a mounting assembly 235.
Mounting assembly 235 includes an upper and a lower mounting portion 236, 238,
respectively. A centrally located pivot member 284 extends from each of upper
and
lower mounting portions 236, 238 through respective openings 246a formed in
coupling
members 246. Coupling members 246 each include an interlocking proximal
portion
246b configured to be received in grooves 290 formed in the distal end of
upper and
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lower housing halves 250, 252 to retain mounting assembly 235 and upper and
lower
housing halves 250, 252 in a longitudinally fixed position in relation to each
other.
Upper housing half 250 and lower housing half 252 are contained within an
outer
sleeve, shell or casing 251. The proximal end of upper housing half 250
includes an
insertion tip 193 extending proximally therefrom. Insertion tip 193 includes
engagement
nubs 254, preferably a pair of diametrically opposed engagement nubs 254,
extending
radially outwardly therefrom, for releasably engaging the distal end of body
14. Nubs
254 form a bayonet-type coupling with the distal end of body 14. Housing
halves 252
and 254 define a channel 400 for slidably receiving axial drive assembly 212
therein. An
articulation link 256 is dimensioned to be slidably positioned within a slot
402 formed in
upper and lower housing halves 250, 252. A pair of blow out plate assemblies
255 are
positioned adjacent the distal end of housing portion 200 adjacent the distal
end of axial
drive assembly 212 to prevent outward buckling and bulging of drive assembly
212
during articulation and firing of surgical stapling apparatus 10. For a
detailed discussion
of the structure and operation of blow out plate assemblies 255, reference is
made to
International Application Serial No. PCT/US02/32031, filed on October 4, 2002,
entitled
"Surgical Stapling Device".
Referring to FIG. 9, optionally, a locking member 288 may be supported on
engagement section 270 of axial drive assembly 212. In operation, when axial
drive
assembly 212 is actuated, by applying a predetermined force to movable handle
member
24 to advance axial drive assembly 212 distally, locking member 288 provides
an audible
and tactile indication that surgical stapling apparatus 10 has been actuated.
For a detailed
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discussion of the structure and operation of locking member 288, reference is
made to the
aforementioned International Application Serial No. PCT/US02/32031. Locking
member
288 may also prevent inadvertent partial actuation of DLU 16, such as during
shipping,
by locking axial drive assembly 212 at a fixed position within DLU 16 until a
predetermined axial force has been applied to axial drive assembly 212.
With reference to FIGS. 9-12, axial drive assembly 212 includes an elongated
drive beam 266 (FIGS. 11 and 12) including a distal working head 268 (FIGS. 11
and 12)
and a proximal engagement section 270. Drive beam 266 may be constructed from
a
single sheet of material or, preferably, multiple stacked sheets, as shown in
FIG. 11.
Engagement section 270 includes a pair of resilient engagement fingers 270a
and 270b
which are dimensioned and configured to mountingly engage a pair of
corresponding
retention slots 272a and 272b formed in drive member 272 (FIGS. 11 and 13).
Drive
member 272 includes a proximal porthole 274 configured to receive distal end
276 of a
drive member, e.g., drive rod or control rod 52 (FIGS. 15 and 20-22) when the
proximal
end of DLU 16 is being engaged with elongated body 14 of surgical stapling
apparatus
10. Control rod 52 functions to impart axial movement of drive assembly 212
from
handle assembly 12.
As seen in FIGS. 9, 10 and 16-22, DLU 16 further includes a locking mechanism
300, preferably, pivotably supported on upper housing half 250. Locking
mechanism 300
is manipulatable from a first position, in which drive assembly 212 is
maintained in a
ready-to-load position, to a second position, in which drive assembly 212 is
free to move.
DLU 16 is considered to be loaded to elongate body 14 when locking mechanism
300 is
in the second position, i.e., when drive assembly 212 is connected to control
rod 52 of
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elongate body 14. Locking mechanism 300 includes a lever 302 including a
distal end
304 pivotally connected to upper housing half 250 and a free proximal end 306
in
operative association with an outer surface of insertion tip 193. Desirably,
distal end 304
is pivotably connected to upper housing half 250, via a pin 308 or preferably
a ball-type
pivot member. Alternatively, other known pivot structures formed integrally
with or
separate from upper housing half 250 may be used. Lever 302 further includes a
projection, here shown as a tooth 310, extending radially inwardly from the
inner surface
of lever 302, preferably at a location between distal end 304 and proximal end
306.
In use, as best seen in FIGS. 16-22, when locking mechanism 300 is in the
first
position (i.e., in a ready-to-load, locked, or Coupled position) (FIGS. 16,
17, 18, 20 and
21), lever 302 is substantially axially aligned with a longitudinal axis of
housing portion
200 such that tooth 310 passes through an aperture 250a formed in upper
housing half
250 and is engaged with an engagement surface, e.g., a notch, shoulder or
recess 270c
formed in the edge of engagement section 270 of drive assembly 212 to thereby
effectively lock and maintain drive assembly 212 in the ready-to-load position
wherein
drive assembly 212 is in a retracted or proximal-most position relative to
upper housing
half 250. When DLU 16 is being coupled to the distal end of body 14, locking
mechanism 300 ensures that engagement section 270 of drive assembly 212 is in
a
position to and properly engages, coupled with or connects to distal end 276
of control
rod 52 (see FIGS. 20-22) of surgical stapling apparatus 10. Distal end 276 of
control rod
52 has one or more engagement surfaces, preferably, and here shown as,
including a head
276a and a smaller diameter annular recess 276b just proximal of head 276a and
partially
defined by head 276a. Thereafter, less preferably concomitantly therewith,
locking
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mechanism 300 is manipulated (here rotated) to the second position wherein
drive
assembly 212 is in an unlocked, operative position in which lever 302 is
angled with
respect to the longitudinal axis of housing portion 200 such that tooth 310 is
released
from and/or otherwise disengaged from engagement surface 270c of engagement
section
270 of drive assembly 212 to free drive assembly 212 to move relative to
housing portion
212, here, upper and lower housing portion 250, 252 of DLU 16.
When locking mechanism 300 is in the second position, DLU is considered
loaded onto ad/or into elongate body 14 of surgical stapling apparatus 10.
Thus, drive
assembly 212 is free to be actuated and reciprocated axially by drive rod 52
to perform its
operative functions of approximating and closing anvil and cartridge
assemblies 18, 20,
driving knife 280 and firing staples, as well as of un-approximating, un-
clamping, and
retracting drive assembly 212. DLU 16 is considered to be loaded to elongate
body 14
when locking mechanism 300 is in the second position, i.e., when drive
assembly 212 is
connected to control rod 52 of elongate body 14.
With continued reference to FIGS. 15-20, preferably lever 302 of locking
mechanism 300 further includes a nub or detent 314 extending radially inward
from an
inner surface 302a of distal end 306 of lever 302. In use, nub 314 selectively
engages
and disengages a recess or dimple 193a formed in the outer surface of
insertion tip 193.
Preferably, dimple 193a is substantially in axial alignment with nubs 254
extending
radially outward from insertion tip 193. Nub 314 and dimple 193a create a snap-
fit type
engagement wherein nub 314 and dimple 193a cooperate with one another to
prevent
and/or otherwise inhibit locking mechanism 300 from inadvertently or
prematurely
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pivoting from the first position to the second position and thereby
disengaging drive
assembly 212. Locking mechanism 300 thus can include nub 314 and dimple 193a.
Preferably, insertion tip 193 includes a recessed area 193b (FIGS. 10 and 16)
formed therein such that locking mechanism 300 does not extend radially
outward
beyond the outer surface of upper housing half 250. Lever 302 is able to pivot
an amount
sufficient to allow tooth 310 to disengage engagement surface or shoulder 270c
of
engagement section 270 of drive assembly 212 when locking mechanism 300 is in
the
second position. Locking mechanism 300 preferably includes a spring or other
biasing
means 312 in operative association with lever 302 and housing portion 200
mounted
and/or positioned in such a manner so as to bias lever 302 to the first
position. As seen in
FIG. 16, spring 312 includes an arm 312a in contact with a side surface 302a
of lever 302
thereby tending to maintain lever 302 in the first position. The twisting
force applied
with respect to DLU 16 and/or elongate body 14 of surgical stapling apparatus
10 is
sufficient to overcome the bias of spring 312 to allow lever 302 to move to
the second
position.
With continued reference to FIGS. 15-20, a method of use and/or operation of
locking mechanism 300, in securing DLU 16 to the distal end of elongate body
14, will
be discussed. Initially, with locking mechanism 300 in the first position such
that tooth
310 is in locking engagement with shoulder 270c of engagement section 270, to
ensure
that drive assembly 212 is in the proper position (e.g., in the proximal-most
position) for
coupling with head 276a of distal end 276 of control rod 52, insertion tip 193
of DLU 16
is introduced longitudinally into the distal end of elongate body 14, in the
direction of
arrow "A", such that nubs 254 slide into channels 276d, through and past
projections
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276c (see FIGS. 15 and 15a) extending radially inward from elongate body 14 of
surgical
stapling apparatus 10 near the distal end thereof.
When nubs 254 have reached slots 276e, and when insertion tip 193 has been
fully inserted into the distal end of elongate body 14, DLU 16 is rotated, in
the direction
of arrow "B" (see FIG. 21). At this point in the coupling, rotation of DLU 16
results in
three separate actions, namely, nubs 254 enter slots 276e, thus connecting DLU
16 to
distal end 14 of stapling apparatus 10; projections 276b of firing rod 52
engage sections
270a and 270b of drive assembly 212, thus connecting firing rod 52 and drive
assembly
212; and side wall of channel 276d urges lever 302 (such that side wall of
channel 276d
abuts against and engages proximal end of lever 306, preferably against a side
surface
302b of lever 302) of locking mechanism 300 to pivot from the first position
to the
second position about pivot pin "P" to thereby disengage tooth 310 from
shoulder 270c of
engagement section 270 and thereby free drive assembly 212 to allow movement
of drive
assembly 212 and permit operation or continued operation of surgical stapling
apparatus
10.
As can be appreciated, if lever 302 has been inadvertently moved to the second
position, prior to coupling of DLU 16 to elongate body 14, and drive assembly
212 has
prematurely moved from its proximal-most or ready-to-load position, lever 302
can not
move to the first position since tooth 310 is not aligned with drive assembly
212 and can
not pass in front of shoulder 270c. In such a situation, tooth 310 will abut
against a
portion of engagement section 270 to prevent lever 302 from returning to the
first
position. Thus, upon insertion of DLU 16 into elongate body 14, proximal end
306 of
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lever 302 will abut against and/or otherwise contact projection 276c of
elongate body 14
and thus prevent loading of DLU 16 to elongate body 14.
Accordingly, the attachment of a DLU having a drive assembly which is not in
its
proximal-most or ready-to-load position is prevented.
Turning now to FIGS. 23-45, a surgical stapling apparatus, according to
another
embodiment of the present disclosure, is generally designated as 1000.
In the interest of brevity, only a discussion of the systems, methods and
structures
for loading, engaging, coupling or connecting a disposable loading unit
("DLU") 1016 to
surgical stapling apparatus 1000 is provided. A detailed discussion of the
remaining
components and method of use of surgical stapling apparatus 1000, is disclosed
in U.S.
Patent 6,241,139.
Surgical stapling apparatus 1000 is an endoscopic apparatus and includes a
handle
assembly 1012 and an elongated body 1014 extending from handle assembly 1012.
A
DLU 1016 is releasably secured to the distal end of elongated body 1014. While
this
disclosure relates to the use of a DLU with surgical stapling apparatus 1000,
it is
understood and within the scope of the present disclosure that a single use
loading unit
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(SULU) or other end effector and/or tool assembly can equally be used in
cooperation
with surgical stapling apparatus 1000.
DLU 1016 includes a tool 1017 having a cartridge assembly 1018 housing a
plurality of surgical staples (not shown) and an anvil assembly 1020 movably
secured in
relation to cartridge assembly 1018. As shown herein, DLU 1016 is configured
to apply
six (6) linear rows of staples, in DLU's measuring from about 30 mm to about
60 mm in
length. DLUs for applying any number of rows of staples, having staple pockets
arranged in various patterns and/or DLUs and end effectors having any other
lengths,
e.g., 45 mm, are also envisioned. Handle assembly 1012 includes a stationary
handle
member 1022, a movable handle member 1024, and a barrel portion 1026.
A rotatable member 1028 preferably is mounted on the forward end of barrel
portion 1026 to facilitate rotation of elongated body 1014 and attached DLU
1016 with
respect to handle assembly 1012. An articulation lever 1030 preferably is also
mounted
on the forward end of barrel portion 1026 adjacent rotatable member 1028 to
facilitate
articulation of tool assembly 1017. Preferably, a pair of knobs 1032 are
movably
positioned along barrel portion 1026. Knobs 1032 are advanced distally to
approximate
or close cartridge and/or anvil assembly 1018, 1020, and retracted proximally
to
unapproximate or open cartridge and/or anvil assembly 1018, 1020.
As seen in FIG. 26, DLU 1016 is desirably selectively removably couplable to
elongated body 1014. DLU 1016 includes a housing portion 1200 having a
proximal end
adapted to releasably engage the distal end of elongated body 1014. A mounting
assembly 1202 is pivotally secured at 1203 to the distal end of housing
portion 1200, and
CA 02618839 2008-01-16
is configured to receive the proximal end of tool assembly 1017 such that
pivotal
movement of mounting assembly 1202 about an axis at 1203 perpendicular to the
longitudinal axis of housing portion 1200 effects articulation of tool
assembly 1017.
Surgical stapling apparatus 1000 is capable of receiving a non-articulating
DLU
1016a, as seen in FIG. 27, or an articulating DLU 1016, as seen in FIGS. 28-
308. U.S.
Patent 6,241,139 includes a detailed discussion of articulating and non-
articulating DLU.
With general reference to FIGS. 31, 31a, 32-35, 37 and 39-45 and particular
reference to FIGS. 31, 31a, 37, 39 and 40, DLU 1016 includes a mounting
assembly
1235. Mounting assembly 1235 includes an upper and a lower mounting portion
1236,
1238, respectively. A centrally located pivot member 1284 extends from each of
upper
and lower mounting portions 1236, 1238 through respective openings 1246a
formed in
coupling members 1246. Coupling members 1246 each include an interlocking
proximal
portion 1246b configured to be received in grooves 1290 formed in the proximal
end of
upper and lower housing halves 1250, 1252 to retain mounting assembly 1235 and
upper
and lower housing halves 1250, 1252 in a longitudinally fixed position in
relation to each
other.
Upper housing half 1250 and lower housing half 1252 are contained within an
outer sleeve, shell or casing 1251. The proximal end of upper housing half
1250 includes
radially outwardly extending engagement nubs 1254 for releasably engaging the
distal
end of body 1014. Nubs 1254 form a bayonet-type coupling with the distal end
of body
1014. Housing halves 1250 and 1252 define a channel 1400 for slidably
receiving axial
drive assembly 1212 therein. An articulation link 1256 is dimensioned to be
slidably
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positioned within a slot 1402 formed in upper and lower housing halves 1250,
1252. A
pair of blow out plate assemblies 1255 are positioned adjacent the distal end
of housing
portion 1200 adjacent the distal end of axial drive assembly 1212 to prevent
outward
buckling and bulging of drive assembly 1212 during articulation and firing of
surgical
stapling apparatus 1000. For a detailed discussion of the structure and
operation of blow
out plate assemblies 1255, reference is made to International Application
Serial No.
PCT/US02/32031, filed on October 4, 2002, entitled "Surgical Stapling Device",
the
entire content of which is herein incorporated by reference.
Referring to FIG. 31, optionally, a locking member 1288 may be supported on
engagement section 1270 of axial drive assembly 1212. In operation, when axial
drive
assembly 1212 is actuated, by applying a predetermined force to movable handle
member
1024 to advance axial drive assembly 1212 distally, locking member 1288
provides an
audible and tactile indication that surgical stapling apparatus 1000 has been
actuated. For
a detailed discussion of the structure and operation of locking member 1288,
reference is
made to the aforementioned International Application Serial No.
PCT/US02/32031.
Locking member 1288 may also prevent inadvertent partial actuation of DLU
1016, such
as during shipping, by locking axial drive assembly 1212 at a fixed position
within DLU
1016 until a predetermined axial force has been applied to axial drive
assembly 1212.
With reference to FIGS. 31-34, axial drive assembly 1212 includes an elongated
drive beam 1266 (FIG. 33) including a distal working head 1268 (FIG. 34) and a
proximal engagement section 1270. Drive beam 1266 may be constructed from a
single
sheet of material or, preferably, multiple stacked sheets, as shown in FIG.
33.
Engagement section 1270 includes a pair of resilient engagement fingers 1270a
and
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1270b which are dimensioned and configured to mountingly engage a pair of
corresponding retention slots 1272a and 1272b formed in drive member 1272
(FIG. 34).
Drive member 1272 includes a proximal porthole 1274 configured to receive
distal end
1276 of a drive member, e.g., drive rod or control rod 1052 (FIGS. 36 and 38-
40) when
the proximal end of DLU 1016 is being engaged with elongated body 1014 of
surgical
stapling apparatus 1000. Control rod 1052 functions to impart axial movement
of drive
assembly 1212 from handle assembly 1012.
With reference to FIGS. 31, 31a and 37-45, DLU 1016 further includes a locking
mechanism 1300, preferably pivotably supported on a housing, e.g., on upper
housing
half 1250. Locking mechanism 1300 is manipulatable from a first position, in
which
drive assembly 1212 is maintained in a ready-to-load position for proper
loading, to a
second position, in which drive assembly 1212 is free to move. DLU 1016 is
considered
to be loaded to elongate body 1014 when locking mechanism 1300 is in the
second
position, i.e., when drive assembly 1212 is connected to control rod 1052 of
elongate
body 1014. As seen in FIGS. 31, 31a and 37-45, locking mechanism 1300 includes
a
lever 1302 pivotally connected to upper housing half 1250 by a pivot pin 1308
extending
therethrough, thereby defining a pivot point. Lever 1302 includes a free
distal end 1304
extending distally of pivot pin 1308 and a free proximal end 1306 extending
proximally
of pivot pin 1308. Proximal end 1306 of lever 1302 terminates in an angled
surface
1306a formed along an upper surface thereof for engaging a portion of elongate
body
1014, as will be discussed in greater detail below. Distal end 1304 of lever
1302
terminates in a hook member 1304a formed along a lower surface thereof for
engaging
drive member 1272, as will be discussed in greater detail below.
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Locking mechanism 1300 further includes a biasing member or spring 1312,
preferably a leaf spring, operatively associated with upper housing half 1250
and distal
end 1304 of lever 1302. Preferably, spring 1312 maintains lever 1302 in the
first position
such that hook member 1304a is engaged with drive member 1272. Spring 1312
includes
a proximal end 1312a operatively associated with distal end 1304 of lever
1302, and a
distal end 1312b secured to upper housing half 1250. Preferably, distal end
1312b is in
the form of a hook or bent arm extending into a slot or groove 1250a (see
FIGS. 39-42) in
upper housing half 1250 in such a manner so as to create a force "F" acting
radially
inward at proximal end 1312a of spring 1312 (see FIG. 39). Proximal end 1312a
is
positioned in engagement with an outer surface 1304b of distal end 1304 of
lever 1302.
As such, force "F" in turn acts on distal end 1304 of lever 1302 to thereby
urge distal end
1304 radially inward as well. In so doing, proximal end 1306 of lever 1302 is
urged
radially outward due to the pivoting action of lever 1302 about pivot pin
1308.
Prior to attachment of DLU 1016 to surgical stapling apparatus 1000, lever
1302
of locking mechanism 1300 is urged to the locked position by spring 1312
(FIGS. 37, 39
and 40). As discussed above, in the locked position, lever 1302 is pivoted
about pivot pin
1308 such that hook member 1304a of lever 1302 is in engagement with a distal
face
1272c of drive member 1272 and proximal end 1306 is positioned radially
outward of an
outer surface 1193a of insertion tip 1193 (see FIG. 40). In this locked
position, hook
member 1304a prevents inadvertent distal advancement of drive member 1272 to
maintain drive member 1272 in its proximal-most ready-to-load position. This
ensures
that engagement section 1270 of drive assembly 1212 properly engages the
distal end
1276 of control rod 1052 (see FIG. 36) of stapling apparatus 1000 when DLU
1016 is
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mounted to elongated body 1014 of stapling apparatus 1000. Distal end 1276 of
control
rod 1052 has one or more engagement surfaces, preferably, and here shown as,
including
a head 1276a and a smaller diameter annular recess 1276b just proximal of head
1276a
and partially defined by head 1276a.
When DLU 1016 is mounted to elongated body 1014 of stapling apparatus 1000,
in a manner to be discussed in further detail below, angled surface 1306a of
proximal end
1306 of lever 1302 engages sloping surface 1276f of elongate body 1014 (see
FIGS. 42,
44 and 45). Engagement between angled surface 1306a and sloping surface 1276f
pivots
or rotates lever 1302 about pivot pin 1308 to cam proximal end 1306 of lever
1302
radially inwardly. Movement of proximal end 1306 radially inwardly effects
movement
of hook 1304a radially outwardly against force "F" of spring 1312, such that
hook 1304a
is released from and/or otherwise disengaged from drive member 1272 to free
drive
assembly 1212 and enable the operation or continued operation of surgical
stapling
apparatus 1000.
As best seen in FIG. 38, preferably the distal end of elongate body 1014
includes
a recess 1276e formed therein having a shape to facilitate manipulation of
locking
mechanism 1300 from the first position to the second position. Preferably,
recess 1276e
includes a sloping surface 1276f against which angled surface 1306a of lever
1302
contacts. In particular, sloping surface 1276f is shaped such that twisting of
DLU 1016
in relation to elongated body 1014 of stapling apparatus 1000, after insertion
tip 1193 of
DLU 1016 has been inserted into the distal end of elongate body 1014, results
in
proximal end 1306 of lever 1302 being progressively urged or cammed radially
inward.
Only after DLU 1016 has been rotated over a sufficient arc in relation to body
1014 will
CA 02618839 2008-01-16
proximal end 1306 of lever 1302 be cammed radially inwardly a distance
sufficient to
release hook member 1304a from drive member 1272.
With continued reference to FIGS. 37-45, a method of use and/or operation of
locking mechanism 1300, when securing DLU 1016 to the distal end of elongate
body
1014, will be discussed. Initially, with locking mechanism 1300 in the first
position such
that hook 1304a is in engagement with drive member 1272, insertion tip 1193 of
DLU
1016 is introduced longitudinally into the distal end of elongate body 1014,
in either
direction of arrow "A" (FIG. 41). As seen in FIGS. 41, 42 and 44, during
introduction of
insertion tip 1193 into the distal end of elongate body 1014, proximal end
1306 of lever
1302 enters recess 1276b (FIG. 42) formed in the distal end of elongate body
1014.
When insertion tip 1193 has been fully inserted into the distal end of
elongate
body 1014, and more particularly, when nubs 1254 have completely entered
channels
1276d (FIG. 38, 44 and 45), DLU 1016 is rotated, in the direction of arrow "B"
(FIG. 41
and 45), such that sloping surface 1276f of recess 1276e acts against and
engages angled
surface 1306a of proximal end 1306 of lever 1302. As described above, the
camming
action between sloping surface 1276f of recess 1276e and angled surface 1306a
of
proximal end 1306 causes proximal end 1306 of lever 1302 to be urged radially
inward,
as indicated by arrow "C" of FIG. 45, and about pivot pin 1308, thereby
overcoming
force "F" of spring 1312, and urging distal end 1304 radially outward such
that lever
1302 is urged from the first position to the second position. Displacement of
distal end
1304 in a radially outward direction results in hook 1304a becoming disengaged
from
drive member 1272 thereby freeing drive assembly 1212 for the continued
operation of
surgical stapling apparatus 1000. DLU 1016 is considered to be loaded to
elongate body
31
CA 02618839 2014-08-12
1014 when lever 1302 is in the second position, e.g., when drive assembly 1212
is
connected to drive member or control rod 1052 of elongate body 1014.
Accordingly, the attachment of a DLU, having a drive assembly 1212, to the
distal end of elongate body 1014 when drive assembly 1212 is not in its
proximal-most or
proper loading position is prevented.
It will be understood that various modifications may be made to the
embodiments
disclosed herein. Therefore, the above description should not be construed as
limiting,
but merely as exemplifications of preferred embodiments. The scope of the
claims should not be
limited by the preferred embodiments set forth herein, but should be given the
broadest
interpretation consistent with the description as a whole.
32
