U.S. patent number RE36,720 [Application Number 08/812,636] was granted by the patent office on 2000-05-30 for apparatus and method for applying latchless surgical clips.
This patent grant is currently assigned to United States Surgical Corporation. Invention is credited to David T. Green, Richard McGarry, Daniel Shichman, Boris Zvenyatsky.
United States Patent |
RE36,720 |
Green , et al. |
May 30, 2000 |
Apparatus and method for applying latchless surgical clips
Abstract
A disposable apparatus is disclosed for applying latchless
surgical clips to body tissue in endoscopic surgical procedures.
The latchless clips are resiliently biased to a closed
configuration. The apparatus includes a frame which is adapted to
be gripped by hand, and an endoscopic section connected to the
handle and capable of storing surgical clips in preparation for
clipping arteries or other body tissue. The apparatus includes
means for advancing each clip sequentially, temporarily opening the
clip and advancing the clip further to a pair of distal jaws where
the clip is positioned around the body tissue and closes around the
tissue. Also included are means for closing the jaws about the
clip. When the jaws are closed, the clip advancing means is
simultaneously positioned to advance the next clip. The present
apparatus also makes it possible to partially close a clip without
interfering with the sequential movement of the clip advancing
mechanism.
Inventors: |
Green; David T. (Westport,
CT), Shichman; Daniel (Trumbull, CT), Zvenyatsky;
Boris (Bronx, NY), McGarry; Richard (Norwalk, CT) |
Assignee: |
United States Surgical
Corporation (Norwalk, CT)
|
Family
ID: |
26765777 |
Appl.
No.: |
08/812,636 |
Filed: |
March 7, 1997 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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626841 |
Dec 13, 1990 |
5366458 |
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Reissue of: |
081630 |
Jun 23, 1993 |
05395381 |
Mar 7, 1995 |
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Current U.S.
Class: |
606/151;
227/19 |
Current CPC
Class: |
A61B
17/122 (20130101); F16B 2/22 (20130101); A61B
17/1285 (20130101) |
Current International
Class: |
A61B
17/122 (20060101); A61B 17/12 (20060101); F16B
2/22 (20060101); F16B 2/20 (20060101); A61B
017/04 () |
Field of
Search: |
;606/143,142,219 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2330182 |
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Jan 1975 |
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DE |
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3802651 |
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Aug 1989 |
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DE |
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9003763 |
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Apr 1990 |
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WO |
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Primary Examiner: Jackson; Gary
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
This is a continuation-in-part of U.S. application Ser. No.
626,841, filed Dec. 13, 1990 .Iadd.now U.S. Pat. No.
5,366,458.Iaddend..
Claims
What is claimed is:
1. An apparatus for endoscopic application of surgical clips to
body tissue, which comprises:
a) a frame,
b) endoscopic means of generally elongated configuration defining a
longitudinal axis and connected to said frame and extending
distally therefrom, said endoscopic means including a tubular
housing defining an internal passage and having a distal end
portion, and further including:
(i) means for storing a plurality of surgical clips in the internal
passage of said tubular housing and a plurality of surgical clips
stored in said storing means, each of said surgical clips
possessing a pair of legs which are movable between a first
position wherein said legs are in relatively close proximity with
each other, a second open position wherein said legs are relatively
spaced apart from each other, and a third closed position wherein
said legs are in relatively close engaged relation with tissue
gripped therebetween, said legs being resiliently biased toward
said first position, said surgical clips being stored in said
storing means in said first position,
(ii) clip opening means located in the internal passage of said
tubular housing for moving said surgical clip legs from said first
position to said second open position,
(iii) clip advancing means movable within the interior passage of
said tubular housing for individually distally advancing said
surgical clips to a location wherein said clips are permitted to at
least partially surround body tissue when said clip legs are in
said second open position; and
(iv) means positioned at said distal end portion of said tubular
housing for moving said clip legs to said third position to effect
closure of said surgical clips at least sufficient to grip the body
tissue.
2. The apparatus of claim 1, wherein said surgical clip legs
possess opposing tissue clamping surfaces and tissue clamping means
on said tissue clamping surfaces, said tissue clamping means of one
leg being cooperatively engageable with said tissue clamping means
of the other leg to impart a tissue clamping force to body tissue
positioned therebetween.
3. The apparatus of claim 1, wherein said surgical clip includes at
least one projection on each of said legs.
4. The apparatus of claim 3, wherein said clip opening means
comprises a track portion having at least one camming surface
positioned such that upon distal advancing of said clips said
projections contact said camming surface and are laterally moved to
a more spaced apart configuration.
5. The apparatus of claim 1, wherein said surgical clips each have
at least one projection for engagement by said advancing means.
6. The apparatus of claim 5, wherein said clip advancing means
comprises a fork shaped distal end portion for engaging said
projection of the clip.
7. The apparatus of claim 1, wherein said surgical clips are stored
in said clip storing means in a row aligned with the longitudinal
axis of the instrument.
8. The apparatus of claim 1, wherein said means for effecting
closure of the surgical clip comprises jaw means positioned at the
distal end of the endoscopic means.
9. The apparatus of claim 8, wherein said clip advancing means
advances the surgical clips to a position between said jaw means
for positioning adjacent to the body tissue to be clipped.
10. The apparatus according to claim 9, wherein said frame
comprises an instrument body and an actuating handle mounted to
said instrument body.
11. The apparatus according to claim 10, wherein said frame
contains first transmission means for linearly transferring motion
from said actuating handle to said clip advancing means.
12. The apparatus according to claim 11, wherein said frame
contains second transmission means for linearly transferring motion
from said actuating handle to said jaw closing means.
13. The apparatus according to claim 11, wherein said endoscopic
section is rotatable independent of said handle.
14. The apparatus according to claim 11, further comprising means
for locking said handle such that after actuating said handle to
close said jaws, said handle cannot be actuated unless said locking
means is released.
15. The apparatus according to claim 14, wherein said handle
locking means comprises a first resilient catch movable in response
to actuation of said handle from an unlocked position to a locked
position wherein first transmission means is advanced and locked,
release means adapted to release said first resilient catch, said
first resilient catch being returnable to the unlocked position in
response to actuation of said release means, and a second resilient
catch movable in response to actuation of said handle from an
unlocked position to a locked position wherein it engages and locks
second transmission means, said second resilient catch being
resiliently returnable to the unlocked position in response to the
release of said resilient catch.
16. The apparatus according to claim 8, wherein said jaw means
comprises a pair of jaws positioned in spaced relation and
configured and dimensioned for reception of a surgical clip
therebetween, said jaws each having a clip contacting edge adapted
to engage a corresponding notch on the outer edge of the clip, said
jaws being resiliently movable toward and away from each other in
response to longitudinal movement of a camming means between a
proximal position and a distal position.
17. The apparatus according to claim 16, wherein said camming means
comprises a channel member slidably mounted within said endoscopic
section and longitudinally movable in response to actuation of said
handle, said channel member having at least two distal camming
surfaces for biasing the jaws into said closed position.
18. The apparatus according to claim 1, wherein said means for
storing surgical clips comprises a track for holding a longitudinal
array of surgical clips, and spring means located proximal to the
array of surgical clips for biasing said surgical clips toward the
distal direction.
19. The apparatus according to claim 18, further comprising a clip
follower and a clip track positioned between said jaw means and
said clip follower.
20. The apparatus according to claim 1, wherein said means for
advancing the surgical clips comprises a pusher bar for advancing
the distal-most clip into said means for moving said clip legs to
said third position, said pusher bar being longitudinally slidable
in response to actuation of said handle.
21. The apparatus according to claim 1, wherein said endoscopic
section includes a gaseous seal means.
22. An apparatus for endoscopic application of surgical clips to
body tissue, which comprises:
a) a frame configured and dimensioned for manual gripping,
b) an endoscopic shaft of generally elongated configuration
defining a longitudinal axis and connected to said frame and
extending distally therefrom, said endoscopic shaft including a
tubular housing defining an internal passage and having a distal
end portion, and further including:
(i) means for storing a plurality of surgical clips in the internal
passage of said tubular housing and a plurality of surgical clips
stored in said storing means, each of said surgical clips
possessing a pair of legs which are movable between a first
position wherein said legs are in relatively close proximity with
each other, a second open position wherein said legs are relatively
spaced apart from each other, and a third closed position wherein
said legs are in relatively close engaged relation with tissue
gripped therebetween, said legs being resiliently biased toward
said first position, said surgical clips being stored in said
storing means in said first position,
(ii) clip opening means located in the internal passage of said
tubular housing for moving said surgical clip legs from said first
position to said second open position,
(iii) clip advancing means movable within the interior passage of
said tubular housing for individually distally advancing said
surgical clips to a location wherein said clips are permitted to at
least partially surround body tissue when said clip legs are in
said second open position; and
(iv) means positioned at said distal end portion of said tubular
housing for moving said clip legs to said third position to effect
closure of said surgical clips at least sufficient to grip the body
tissue.
23. A disposable apparatus for endoscopic application of latchless
surgical clips to body tissue, said clips each having a pair of
legs normally biased toward a first position wherein said legs are
in relatively close proximity with each other, and resiliently
movable toward a second open position which comprises:
a) a frame adapted to be gripped by hand;
b) an elongated endoscopic section connected to said frame, said
endoscopic section comprising a tubular housing with a distal end
portion and further including:
i) means for storing a plurality of latchless clips in the interior
of said tubular housing;
ii) a pair of jaws at the distal end portion of said tubular
housing, said jaws being configured and dimensioned for reception
and clamping of said latchless surgical clips;
iii) means extending through the interior of said tubular housing
for advancing said latchless surgical clips into said jaws;
iv) means located in said tubular housing for causing said legs to
move toward said open position to facilitate positioning of said
clip about body tissue to be clipped; and
v) means for moving said jaws toward each other for closing a clip
positioned therebetween.
24. A method for endoscopically applying latchless surgical clips
with an apparatus having a frame adapted to be gripped by hand and
an endoscopic section connected to said frame, comprising:
a) storing a plurality of said latchless surgical clips in said
endoscopic section, each of Said latchless surgical clips having a
pair of legs resiliently biased toward a closed position and
movable away from each other to an open position;
b) distally advancing one of said latchless surgical clips to a
pair of jaws positioned at a distal end of said endoscopic section
by clip advancing means positioned within said endoscopic
section;
c) positioning said latchless surgical clip adjacent body tissue to
be clipped;
d) closing said jaws about said latchless surgical clip while
permitting said clip legs to move toward the closed position, and
substantially simultaneously repositioning said clip advancing
means to a position proximal of the next clip to be advanced;
and
e) releasably locking said clip advancing means in said proximal
position until released to advance the next clip. .Iadd.
25. An apparatus for endoscopic application of surgical clips to
body tissue, which comprises:
a) a frame;
b) an elongated body portion extending distally from the frame and
having a distal end portion, the elongated body portion defining a
longitudinal axis and an internal passage therein;
c) a storage magazine defined within the internal passage of the
elongated body portion configured to retain a plurality of surgical
clips;
d) a plurality of surgical clips positioned in the storage
magazine, each of the surgical clips having a pair of legs movable
between an approximated position wherein the legs are in
approximation and an open position wherein the legs are spaced
apart, the legs being biased towards the approximated position, the
surgical clips being stored in the storage magazine in the
approximated position;
e) a clip advancer movably mounted relative to the body portion, at
least a portion of the clip advancer positioned within the internal
passage;
f) first and second jaw structure mounted adjacent said distal end
of the elongated body portion and defining a tissue receiving space
therebetween;
g) at least one camming surface at least partially disposed
adjacent the first and second jaw structure, wherein said at least
one camming surface progressively cams the legs of the surgical
clips towards the open position and said at least one camming
surface permits the legs of the surgical clip to subsequently move
towards the approximated position while said surgical clip is at
least partially within the tissue receiving space. .Iaddend.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to an apparatus and method for applying
surgical clips, especially hemostatic clips, to body tissue such as
blood vessels. More particularly, this invention relates to a
surgical clip applier which can be used in laparoscopic or
endoscopic procedures for closing ducts, arteries and the like, and
to a method for using same.
2. Background of the Art
In surgical operations it is often necessary to apply hemostatic
clips to blood vessels, and apparatus for applying clips are known
in the art. See, for example, U.S. Pat. No. 4,616,650 and
4,624,254, both of which are hereby incorporated by reference in
their entirety, which disclose a
surgical clip applying apparatus having ring-like handles. The
handles are squeezed to force jaws to move distally relative to the
apparatus where they are forced together by a pair of inclined
surfaces. A surgical clip between the jaws is thereby squeezed
closed.
While the instruments described in the above-referenced patents
have provided beneficial features to surgeons in conventional
surgical procedures, they are not useful in endoscopic or
laparoscopic operations. 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 insuffiated. 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 to be used in such procedures be
both long and narrow. In either laparoscopic or endoscopic surgery,
the functional portion of the instrumentation is controlled from
outside the body. Mechanical actuation of such instruments is for
the most part constrained to movement of the various components
along a longitudinal axis, even if lateral movement is employed at
the operating site. The initial opening in the body tissue to allow
passage of the endoscopic tube to the interior of the body can be a
natural passageway of the body (e.g. bronchial tubes), or it can be
created by a tissue piercing instrument such as a trocar. Because
the endoscopic or laparoscopic tubes, instrumentation, and any
required puncture are relatively narrow, endoscopic or laparoscopic
surgery is less invasive and causes much less trauma to the patient
as compared with procedures in which the surgeon is required to cut
open large areas of body tissue.
An endoscopic apparatus for applying surgical clips is described in
U.S. Pat. Nos. 5,084,057 and 5,100,420, both of which are
incorporated herein by reference in their entirety. The apparatus
described in these patents apply generally U-shaped or V-shaped
clips fabricated from a metal such as titanium or stainless steel.
The clips are positioned between the jaws of the instrument which
are then closed to squeeze the clip legs together.
As an alternative to metal, polymers are also used to fabricate
surgical clips. The polymers can be bioabsorbable or
non-bioabsorbable. Surgical clips fabricated from polymers are
described in U.S. Pat. Nos. 4,418,694; 4,476,865; 4,492,232;
4,512,345; 4,527,562; 4,557,263; 4,590,937; 4,620,541; 4,638,804;
4,646,741; and 4,741,337. Bioabsorbable polymers include, for
example, homopolymers and copolymers of lactide, glycolide,
caprolactone and p-dioxanone. These polymers have the advantage of
decomposing in the body after a period of time. A separate
operation to remove them is unnecessary. Therefore, they can be
used in situations where the clip is not intended to be permanently
placed in the body. Non-bioabsorbable polymers which are known to
be useful for the manufacture of surgical clips include polyesters,
polyamides, polycarbonates, polyvinyl chlorides, polysulfones, and
polypropylenes.
Up to the present, polymeric clips have been latched, i.e. the
opposing "arm" or "leg" members which clamp the body tissue lock
together by means of some type of latch mechanism. More recently,
another type of polymeric surgical clip has been developed which is
latchless. A latchless polymeric surgical clip is disclosed in
commonly assigned U.S. patent application Ser. No. 07/626,841,
filed Dec. 13, 1990, herein incorporated by reference in its
entirety. Up to the present, it has been desirable to develop an
apparatus for applying latchless clips. The present invention
provides an apparatus and method for applying such latchless
clips.
SUMMARY OF THE INVENTION
An apparatus is disclosed for applying latchless surgical clips to
body tissue. The latchless clips each possess a pair of legs
movable between a closed position wherein the legs are in
relatively close proximity to each other and an open position
wherein the legs are relatively spaced apart from each other. The
legs are resiliently biased to the closed position. The apparatus
comprises frame means, and endoscopic means of generally elongated
configuration connected to the frame means and extending distally
therefrom. The endoscopic means includes: means for storing a
plurality of latchless surgical clips, means for opening the clips,
means for selectively advancing the clips to the distal portion of
the endoscopic means for positioning adjacent the body tissue to be
clipped where the clips are permitted to at least partially close;
and means for facilitating substantially complete closure of each
clip at least sufficient to grip the body tissue. The apparatus may
be completely disposable and the endoscopic means may be
replaceable so as to permit additional clips to be applied with a
single apparatus during a single surgical procedure.
In one embodiment, a disposable apparatus is disclosed for applying
surgical clips to body tissue which comprises a frame configured
and dimensioned for manual gripping, an elongated endoscopic
section connected at the proximal end thereof to the frame and
extending distally therefrom, the endoscopic section including
means for storing a plurality of latchless surgical clips in
generally aligned relation facing the distal portion thereof, jaw
means positioned at the distal end thereof and adapted for
sequential reception of the latchless clips, means for sequentially
advancing and opening the latchless clips distally so as to be
positioned between the jaw means for positioning adjacent the body
tissue to be clipped, and means for sequentially at least partially
closing the jaw means about each clip after the clip is advanced
therebetween while simultaneously repositioning the clip advancing
means for distal advancement of the next clip.
Preferably, an instrument body is provided and an actuating handle
mounted to the instrument body, with first transmission means for
linearly transferring motion from the actuating handle to the clip
advancing means and means to close the jaw means. Second
transmission means is provided for linearly transferring motion
from the actuating handle to the jaw closing means, and means is
provided for locking the handle such that after actuating the
handle to close the jaws the handle cannot be actuated unless the
locking means is released. The endoscopic section is rotatable
independent of the handle, with means being provided to selectively
lock the endoscopic section at a predetermined angular orientation
relative to the handle. Means is provided to release the lock means
of the endoscopic section so as to permit rotation thereof relative
to the handle. Handle locking means comprises a first resilient
catch movable in response to actuation of the handle from an
unlocked position to a locked position wherein the first
transmission means is advanced and locked. Release means is adapted
to release the first resilient catch, the first resilient catch
being returnable to the unlocked position in response to actuation
of the release means. A second resilient catch is movable in
response to actuation of the handle from an unlocked position to a
locked position wherein it engages and locks the second
transmission means. The second resilient catch is resiliently
returnable to the unlocked position in response to the release of
the resilient catch. The first transmission means comprises means
responsive to actuation of the release means to release the second
transmission means.
The jaw means preferably comprises a pair of jaws positioned in
spaced relation and configured and dimensioned for reception of a
latchless surgical clip therebetween. The jaws are resiliently
movable toward and away from each other in response to distal
movement of a camming means from a proximal position to a distal
position. The camming means comprises a channel member slidably
mounted within the endoscopic section and longitudinally movable in
response to actuation of the handle, the channel member having at
least two distal camming surfaces for biasing the jaws into the
closed position. Means for storing latchless surgical clips
comprises a track for holding a longitudinal array of latchless
surgical clips, and resilient means located proximal to the array
of latchless surgical clips for biasing the clips toward the distal
direction. A clip track is positioned between the jaw means and The
clip follower. Means for advancing the latchless surgical clips
comprises a pusher bar for individually advancing the distal-most
clip in the area of the pair of jaws, the pusher bar being
longitudinally slidable in response to actuation of the handle. The
pusher bar is movable between a first position wherein the distal
end of the pusher bar is located proximally of the latchless
surgical clip to be advanced, and a second position wherein the
distal end of the pusher bar advances the latchless surgical clip
to the jaw means.
The first transmission means acts on the pusher bar positioned
within the endoscopic section and comprises a proximal pusher tube
connected to the proximal end of the pusher bar. The first pusher
tube includes mounting means for rotatably connecting the pusher
bar thereto. The mounting means of the pusher tube comprises a
generally circular shaped projection dimensioned for reception and
engagement of at least one cooperating projection on the pusher
bar.
The second transmission means acts on a channel member positioned
within the endoscopic section, and comprises a proximal channel
tube connected to the proximal end portion of the channel member.
The channel tube includes mounting means for rotatably connecting
the channel tube to the channel member. Links connect the second
transmission means to a lever actuator and convert the rotational
movement of the lever to linear movement of the channel tube.
The jaw means preferably comprises a jaw blade fixed to the
endoscopic section and having a pair of distal spaced jaws which
are resiliently movable between a closed position for closing a
latchless surgical clip and an open position for reception of the
latchless surgical clip. The camming means is comprised of a
channel member having camming surfaces movable from a first
position proximal of the jaws, and second distal position wherein
the camming surfaces of the channel member move the jaws to the
closed position. The channel member is connected at its proximal
end to the channel tube.
The rotatable mounting means of the channel tube comprises a
circumferential projection dimensioned for engaging at least one
cooperating notch in the camming means. The endoscopic section is
rotatable about a longitudinal axis extending relative to the frame
between a plurality of click-stop settings. Further, endoscopic
section is preferably adapted to provide a gaseous seal means in
the form of silicone grease.
A method is also disclosed for endoscopically applying latchless
surgical clips with an apparatus having a frame adapted to be
gripped by hand and an endoscopic section connected to the frame
and rotatable to selected positions relative to the frame,
comprising storing the latchless clips in the endoscopic section,
sequentially advancing a clip distally by clip advancing means
positioned within the endoscopic section to a pair of jaws
positioned at the distal end of the endoscopic section and opening
the clip therewithin, positioning the clip adjacent body tissue to
be clipped, closing the jaws about the clip while permitting the
clip to close and simultaneously repositioning the clip advancing
means to a position proximal of the next clip to be advanced, and
releasably locking the clip advancing means in that position until
released to advance the next clip.
BRIEF DESCRIPTION OF THE DRAWINGS
Preferred embodiments of the invention are described below with
reference to the drawings wherein:
FIG. 1 is a perspective view of the disposable apparatus for
placing clips in laparoscopic or endoscopic procedures constructed
according to the present invention;
FIG. 2 is a perspective view with parts separated for purposes of
illustration of the endoscopic section of the apparatus of FIG.
1;
FIG. 3 is a plan view from above, of the distal portion of the
endoscopic section of the apparatus of FIG. 1 in its initial
condition;
FIG. 4 is a cross-sectional view taken along lines 4--4 of FIG. 3
illustrating the clip pusher in position to push the clip next in
line to a position between the jaws of the apparatus;
FIG. 5 is a plan view of the distal portion of the apparatus with
the clip now advanced and partially opened;
FIG. 6 is a cross-sectional view taken along lines 6--6 of FIG. 5
illustrating the distal portion of the apparatus in elevational
view;
FIG. 7 is a plan view of the distal portion of the apparatus with
the clip further advanced and in position for entry into and
between the jaws;
FIG. 8 is an elevational cross-section view of the apparatus taken
along lines 8--8 of FIG. 6;
FIG. 9 is a plan view of the distal portion of the apparatus with
the clip further advanced and now fully positioned between the jaws
and ready for closure onto body tissue;
FIG. 10 is an elevational cross-section view of the apparatus taken
along lines 10--10 of FIG. 9;
FIG. 11 is a plan view of the distal portion of the apparatus with
the clip now fully closed onto body tissue;
FIG. 12 is an elevational cross-sectional view of the apparatus
taken along lines 12--12 of FIG. 11;
FIG. 13 is a cross-sectional view of the distal portion of the
apparatus taken along lines 13--13 of FIG. 4;
FIG. 14 is a cross-sectional view of the apparatus taken along
lines 14--14 of FIG. 7;
FIG. 15 is a sectional view taken along lines 15--15 of FIG.
12;
FIG. 16 is a perspective view of the clip;
FIG. 17 illustrates a surgical operation for applying clips to
tubular-shaped body tissue;
FIG. 18 is a perspective view with parts separated for purposes of
illustration of the handle section of the apparatus of FIG. 1
utilized for activating the endoscopic section;
FIG. 18a is a perspective view of the rotatable collar;
FIG. 19 is an elevational cross-sectional view of the handle of the
apparatus of FIG. 1 illustrating the apparatus in its initial
prefired condition;
FIG. 20 is an elevational cross-sectional view of the handle of the
apparatus of FIG. 1 with the trigger actuated to advance a clip to
the jaws of the apparatus;
FIG. 21 is an elevational cross-sectional view of the handle
section of the apparatus illustrating the actuation of the lever to
close the instrument jaws;
FIG. 22 is a cross-sectional view taken along lines 22--22 of FIG.
19 and illustrating the trigger connection;
FIG. 23 is a cross-sectional view taken along lines 23--23 of FIG.
19 and illustrating the channel tube and pusher member;
FIG. 24 is a view taken along lines 24--24 of FIG. 19 illustrating
the rack and pinion assembly; and
FIG. 25 is a cross-sectional view taken along line 25--25 of FIG.
19 illustrating the lever linkages.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
1. Preface
In the following description it should be noted that such terms as
"distal" and "proximal", "upper" and "lower", "horizontal" and
"vertical", "above" and "below", are used relative to each other
and do not refer to positions or orientations relative to a frame
of reference external to the apparatus.
Because endoscopic procedures are more common than laparoscopic
procedures, the present invention shall be discussed in terms of
endoscopic procedures and apparatus. However, use herein of terms
such as "endoscopic", "endoscopically" and "endoscopic portion",
among others refer generally to instruments having elongated and
relatively narrow operating portions for
inserting into a cannula, body opening, or small wound in the skin
and should not be construed to limit the present invention to an
apparatus for applying surgical clips only in conjunction with an
endoscopic tube. To the contrary, the present invention may find
use in any procedure where access is limited to a small incision or
body opening, including, but not limited to laparoscopic
procedures. In addition, in the preferred embodiment of the
invention the instrument is disposable. However, re-usable
instruments are also contemplated.
2. Overview of the Apparatus
FIG. 1 illustrates a preferred embodiment of the apparatus of the
present invention. The apparatus is preferably constructed as a
disposable item of several materials as will be described.
Essentially, however, two basic materials are used: a polycarbonate
plastic such as LEXAN brand polycarbonate produced by General
Electric Company, and stainless steel.
Briefly, the apparatus 10 includes two main sections: a handle
section 12, and an endoscopic section 14 which is distal of the
handle section. The endoscopic section 14 of the apparatus is
rotatable with respect to the handle section 12 by turning knob 176
and is separable and replaceable with another endoscopic
section.
The apparatus has two actuators. A clip pushing system, which
advances a surgical clip to jaw members 24, is operated by
actuation of trigger 16 by a single finger of the user's hand (e.g.
the index finger). The clip closing mechanism is actuated when
lever 18 is squeezed towards handle grip 202 by other fingers of
the user's hand. The clip closing action of the jaws 24 is
accomplished by translating longitudinal drive movement transmitted
through the endoscopic section 14 to lateral motion of jaws 24, as
described below.
3. The Handle Section
Referring now to FIGS. 18 and 19, the handle section 12 of the
apparatus is illustrated with the transmission mechanism for
manually activating the endoscopic section referred to above, i.e.
for advancing clips distally and crimping the clips around a blood
vessel or other tubular structure. Handle section 12 includes a
body 201 (FIG. 19), which houses the actuation means of the
apparatus. The body portion 201 includes a handle 202 and an
opening 203 for receiving the endoscopic section 14 of the
apparatus. A bridge portion 204 is preferably extended over collar
170.
The body 201 is preferably fabricated in halves which may then be
fastened together by fasteners such as screws or rivets.
Alternatively the body halves may be ultrasonically welded or
adhesively attached along their seams or by bosses and transverse
rods or pins in engaging relation. The body 201 is preferably
fabricated from a hard and durable plastic such as LEXAN
polycarbonate material available from General Electric Co. Other
rigid materials are also contemplated, especially materials capable
of being molded into shape while being able to sustain the forces
applied by the transmission mechanism capable of demonstrating
minimal dimensional changes due to temperature or stress.
The clip loading and crimping system is divided into two separate
systems as described in connection with the endoscopic section. As
noted, a first system pushes the clip next in line from a row of
clips to a position within a pair of clamping jaws 24 as described
in connection with the endoscopic section of the apparatus. The
second system closes the pair of jaws 24 around the clips to cause
the clip to grip the intended artery, tissue, or other blood
vessel, while simultaneously repositioning the clip pusher
mechanism to push the clip next in line into position between the
jaws. This procedure is repeated alternately and sequentially until
all clips are spent or the surgical operation is completed.
With reference to FIGS. 18 to 25, the clip pusher and clip closing
actuation mechanisms will now be described. Lever 18 is an actuator
for closing the jaws 24 of the instrument and is pivotally mounted
to the body 201 by means of pin 104 extending transversely to the
body and disposed through aperture 108 in lever 18 (FIG. 18). The
lever 18 includes rearward extension 112 which includes aperture
126 through which pin 110 extends. Pin 110 functions as a pivot for
left channel link 116 and right channel link 118, which extend in a
generally forward or distal direction.
Lever 18 includes depending portion 113 having aperture 114 for
receiving one end of spring 106. The other end of spring 106 is
attached via pin 105 to the interior of handle 202 of the body.
Spring 106 biases lever 18 clockwise as seen from the instrument
orientation as shown in FIG. 19. Actuation of lever 18 requires
counter clockwise pivoting of the lever by the fingers of a user's
hand. Thus, actuation of lever 18 is accomplished against the
biasing force of spring 106.
Left and right channel links 116 and 118, respectively, each
include apertures 116a and 118a, respectively, for receiving pin
110. Upper apertures 116b and 118b in the respective left and right
channel links are pivotally mounted to bosses 127 and 129,
respectively, of channel tube 124. Thus, actuation of lever 18
causes channel links 116 and 118 to push channel tube 124. Thus,
actuation of lever 18 causes channel links 116 and 118 to push
channel tube 124 distally.
Channel tube 124 is an elongated member having a distal opening 123
for receiving the proximal end of the crimping channel 32 by snap
fit engagement of the legs, or prongs 92. Channel tube 124 includes
a central longitudinal passage 128 for receiving pusher member 134,
which is slidably disposed therein.
Referring again to FIGS. 18-25, trigger 16 is an actuator for
advancing the clips to the instrument jaws in response to finger
pressure applied by a user of the instrument. Trigger 16 includes
tabs 16a which are slidably mounted in corresponding slots 206 in
the interior surface of body portion 201 (FIGS. 19, 20, 22).
Attached to trigger 16 is extension member 164 which includes a
lower gear rack 165. Pinion gear 166 is pivotally mounted to the
body 201 and is positioned above rack 165, which it cooperatively
engages. Pinion gear 166 also engages upper rack 135 such that when
lower rack 165 moves proximally, upper rack 135 moves distally.
Upper rack 135 is fixedly mounted to rack holder 145 and possesses
front and rear apertures 136a and 136b, respectively. Rear aperture
136b receives the distal end of spring 148. Front aperture 136a
receives pin 119. Rack holder 145 includes flaps 146 which are
slidably mounted in corresponding slots in body 201, and aperture
147 for receiving pin 119. Spring 148 is for biasing the upper rack
(and the clip pushing transmission) to the proximal position. The
proximal end of the spring 148 is mounted to cross pin 149, which
is fitted to body 201, and the distal end of spring 148 is mounted
to aperture 136b of the upper rack.
Pusher member 134 includes a distal opening 133 for receiving
forked proximal end 90 of clip pusher bar 78 by snap fit
engagement. Pusher member 134 also includes sides 131 and 132
defining a central passage, and apertures 137 through which pin 119
is disposed. Thus, pin 119 fastens pusher member 134, rack holder
145, and upper rack 135 by extending through apertures 137, 147 and
136a.
In operation, proximally pulling trigger actuator 16, as shown in
FIG. 20, causes lower rack 165 to move proximally. Pinion gear 166
thereupon converts the proximal motion of lower rack 165 to the
distal motion of upper rack 135 along with the remainder of clip
pushing transmission system (rack holder 145, pusher member 134,
pusher bar 78) for advancing the distal-most clip in a row of
stored clips to the jaws.
When trigger 16 is released, upper rack 135 and its associated
structures are biased back to their proximal position by means of
spring 148 and trigger 16 is biased forward.
Referring to FIG. 21, squeezing lever 18 towards handle 202 causes
pivotal movement of channel links 116 and 118 which translates to
forward longitudinal motion of channel tube 124.
4. The Rotational Linkage
Referring now to FIG. 3 in conjunction with FIG. 2 and FIGS. 19 and
18a, the feature relating to the rotatable endoscopic section will
be described. Rotating collar 170 is constructed of the same
material as the handle, i.e., preferably a polycarbonate material
such as LEXAN brand material. This collar 170 includes a distal
cylindrical nose section 172 and a proximal barrel section 174. The
proximal face of the barrel section 174 preferably includes a
plurality of proximally extending teeth 176 positioned
circumferentially about the proximal face of the barrel section,
and the cylindrical nose section 172 includes an inwardly extending
rib 178 at the distal end for engaging groove 15a of upper
endoscopic cartridge half 15. In the assembled condition, the
cylindrical nose section rests within the cylindrical distal bore
182 of the distal end of the handle and nose piece 184 is fitted
over the distal cylindrical end of the handle 12 as shown, for
example, in FIGS. 19 and 20. Bearing washer 186 and spring washers
188, 190 are positioned between shoulder 192 of collar 170 and
shoulder 194 formed in the handle body to bias the rotatable collar
in the proximal direction causing tooth 180 on the handle body to
engage the teeth 176 of the collar 170 to thereby fix the rotatable
orientation of the collar. When the surgeon desires to change the
angular orientation of the endoscopic section, the collar 170 is
merely pushed distally to disengage tooth 180 to free the collar
and permit rotation relative to the handle body. Such rotation of
the collar is clearly permitted by the fact that the cylindrical
nose section of the collar is fit snugly within the corresponding
cylindrical distal section 182 of the handle. Except when the tooth
180 of the handle body is engaged with teeth 176 of collar 170, the
collar is otherwise free to rotate within the handle.
Referring now to FIG. 2 in conjunction with FIGS. 1, 18a and 19,
the distal cylindrical section 172 of collar 170 includes a distal
cylindrical opening dimensioned to receive the endoscopic cartridge
formed of upper half 15 and lower half 17 of endoscopic section 14,
with distally positioned tooth 178 of collar 170 positioned within
longitudinally extending groove 15a of upper cartridge half 15 to
cause the cartridge to rotate with the collar 170. Similarly, the
proximal legs 90 of clip pusher bar 178 are permitted to rotate
within the distal end portion 133 of pusher tube 134 and the
proximal legs 92 of the crimping channel 32 are permitted to rotate
within the distal end portion 123 of channel tube 124. Thus, the
entire endoscopic section may be selectively rotated by the surgeon
by simply pushing collar 170 in the distal direction sufficient to
disengage tooth 180 on the handle body and by rotating the collar
170 until the endoscopic section reaches the desired angular
orientation. Thereafter, by merely releasing the collar the bias of
spring washers 190, 188, causes the collar to move proximally, such
that tooth 180 on the handle body engages the appropriate teeth 176
on the collar 170 to lock the position of the collar and the
endoscopic section.
5. The Latchless Clip
Unlike the latching, or locking, surgical clips of the prior art,
the latchless clip of the present invention provides a tissue
clamping force which is self-adjusting for a variety of tissue
types and tissue thicknesses. The ability of the latchless surgical
clip to readily accommodate different tissue clamping situations
with no appreciable risk of tissue injury represents a significant
advantage over the latching, or locking, surgical clips of the
prior art.
Referring to FIG. 16, latchless surgical clip 22 is provided as a
single molded substantially planar polymeric clip body possessing
two legs 44 joined at one end through hinge back region 45.
Latchless surgical clip 22 is molded, e.g., by injection molding,
in an open or pre-application configuration, i.e., with legs 44
spaced apart from each other. As molded, polymeric latchless clip
10 is substantially amorphous, i.e., the molded polymer exhibits
less than 10% crystallinity. After molding in this open
configuration, latchless clip 10 is treated so as to impart a
spring-back property to hinge region 14.
A preferred post-molding clip treatment process of the latchless
clip 22 shown in FIG. 16 involves heating the clip 22 to a
temperature which permits legs 44 to be moved or deflected into a
second position which is different from the as-molded position.
Inasmuch as molded clip 22 is substantially amorphous, clip 22 is
typically heated to a temperature at or above the glass transition
temperature of the polymeric material from which it is fabricated.
Once at or above its glass transition temperature, the
substantially amorphous polymer is soft or rubbery, thereby
facilitating movement of legs 44 to a second position. Once
deflected to this second position, clip 10 is further heated to a
temperature at which crystallization of the polymer commences. In
order to achieve the desired spring back property in hinge back
portion 45, polymeric clip 22 is typically maintained at a
crystallization temperature for a time sufficient to develop at
least 20% crystallinity preferably at least 30% crystallinity, and
most preferably at least 40% crystallinity.
The post-molding treatment of clip 22 typically results in a minor
degree of shrinkage of the clip body, and typically causes a
rounding of any sharp edges present on clip body. However, neither
the shrinkage nor the rounding impinges upon the clinical efficacy
of the device and, indeed, the rounding of sharp edges is generally
desired to reduce the likelihood of tissue puncture or laceration
upon clip application.
After sufficient crystallization is accomplished, clip 22 is cooled
to ambient temperature. Clip 22 remains oriented in its second
position absent an external biasing force away from said second
position. The above-described post-molding treatment imparts an
elastic spring back property to hinge region 45 such that when a
biasing force is applied to legs 44, e.g., a force biasing legs 44
away from each other, and then withdrawn, legs 44 spring back
toward each other, i.e., to or toward their second (pre-spread)
positions.
The flexural strength of the latchless clip of the invention may be
increased through a post-flexing process after the clip has been
subject to a post-molding treatment to achieve the desired degree
of crystallinity and of spring back property in the hinge region.
Post-flexing involves repeatedly and temporarily biasing the legs
apart through application of a temporary biasing force at an
elevated temperature, e.g., 30.degree.-50.degree. C. Such
post-flexing treatment has been found to lessen the internal
stresses experienced by the clip when being applied to tissue at
ambient temperature.
A wide variety of polymeric materials may be used to fabricate
latchless clip 22 of the present invention. The principal
requirement of the polymer is that it develop sufficient
crystallinity upon movement to a second position to impart a
sufficient spring back force to hinge region 45. Of course, the
required spring back force will vary depending on the intended
application of clip 22. Among the materials which are suitable for
the manufacture of clip 10 are non-bioabsorbable polymers such as
the polyesters, polyamides, polycarbonates, polyvinyl chloride,
polysulfones, and polypropylenes. Suitable bioabsorbable polymers
include homopolymers and copolymers of lactide, glycolide,
trimethylene carbonate, caprolactone, and p-dioxanone, and blends
thereof. A preferred bioabsorbable polymer is a copolymer derived
from approximately 80 to 95 weight percent glycolide and 5 to 20
weight percent lactide.
In one preferred embodiment of the present invention, each leg 44
possesses upper and lower parallel rows of spaced-apart staggered
tooth-like projections 46, which cooperatively engage the
corresponding rows of projections on the other leg. Although the
projections are shown to be substantially rectangular in shape,
clearly projections of other configurations and sizes could be
utilized. Additionally, a smaller or greater number of projections
than are shown may be utilized to achieve the interfitting
arrangement of the projections to enhance clip securement. It is
also contemplated that spaced projections may be limited to the
tissue clamping surface of one leg, these projections being adapted
to cooperate with the tissue clamping surface of the opposing leg
to effectively secure clip 22 to tissue.
Latchless clip 22 is applied by a device such as the one described
herein, which possesses means for temporarily resiliently biasing
legs 44 apart by clip opening means and placing the open clip into
position at a desired tissue site. Clip 22 may be provided with
upwardly extending pins 49a and an instrument can be utilized which
grasps the closed clip in its jaws and, following engagement with
pins 49a resiliently biases the legs apart
the required amount to allow application of the clip to the desired
tissue site, e.g., by directing a pushing force against the pusher
post 48, which brings the clip into engagement with the body
tissue. Once applied to the site, the biasing force is withdrawn
whereupon legs 44 return to the closed, or tissue clamping,
configuration thereby providing effective hemostasis.
Referring once again to FIG. 16, post 48 extends upward from the
center of the proximal portion 45 and serves as a pusher post. Post
48 is engaged by clip pusher 78 for advancing clip 22 when clip
pusher 78 is moved distally. Lower projection 43 engages slot 67d
of the track 66 to serve as a guide for proper orientation of clip
22 as it is advanced. Posts extend upward and downward from the
legs 44. Upper posts 49a engage the clip pusher 78 for advancing
the clip 22, and lower posts 49b serve as spreader posts for
interaction with the clip opening means, which comprises a track
portion having at least one, and preferably two camming surfaces
67a and 67b positioned such that upon distal advancing of the clips
the lower posts 49b contact the camming surfaces and are laterally
moved to a more spaced apart configuration. As lower posts 49b cam
against surfaces 67a and 67b (as explained below with reference to
FIG. 3) the legs 44 spread apart. Notches 47 extend along the
outside surface of legs 44.
The clips of the present invention may be constructed in various
sizes according to their intended function. For example, for a
latchless clip to be used in hemostatically occluding a blood
vessel, a length of about 1 cm, a width of about 5 mm and vessel
clamping surface of about 5 mm in length are typical. The
dimensions may be reduced as appropriate, e.g., by about 50%, for
microsurgical applications. Conversely, the dimensions may be
increased as appropriate, e.g., by about 100% for female
sterilization, in which oviduct occlusion is desired. For male
sterilization, occlusion of the vas deferens may be accomplished
with smaller clips. The clip can be molded in various colors to
increase color contrast with surrounding tissue and/or to
facilitate identification of the size of the clip.
The clip body, particularly the hinge region and legs, of the
latchless surgical clip of the invention possesses sufficient
resilience to permit the clip legs to be deflected apart an
appropriate distance to allow the clip to be easily and efficiently
placed on or around the desired tissue. Generally, the clip body is
sufficiently resilient to permit the legs to be deflected to a
position wherein the legs are separated by an angle of from
15.degree. to 50.degree., and more typically an angle of from
20.degree. to 35.degree.. This angle of maximum deflection will
depend on such factors as the polymeric material, the degree of
crystallinity of the clip body after the 15 post-molding treatment,
the physical dimensions of the clip body, the presence of cored
sections, and whether the clip body has experienced post-flexing.
The angle of maximum deflection may correspond to, but is not
necessarily restricted to, the angular opening of the legs in the
as-molded configuration.
The hinge region also possesses a sufficient spring back force to
bring the legs toward each other (once the external biasing force
is removed from the legs) to apply an effective tissue clamping
force to the tissue. The tissue clamping force which the clip must
deliver will depend on such factors as the type and size of the
tissue to which it is to be applied. Typically, in order for the
clip to effectively occlude a tissue structure, e.g., a blood
vessel, the clip should apply a residual force of about 0.5-1.0 psi
once placed on the tissue structure. Once placed on tissue, the
hemostatic latchless clip of the invention maintains that position
for a period of time sufficient to permit hemostasis to take place,
i.e., maintains its strength in vivo so as to withstand the
internal pressure which is trying to force the tissue structure
back open until the natural, permanent sealing of the tissue
structure is complete.
6. The Endoscopic Section
Referring now to FIG. 2 in conjunction with FIGS. 3 to 14 and FIG.
1, the endoscopic section 14 of the apparatus will now be
described. The endoscopic section 14 is preferably housed in a
non-removable cartridge formed of upper half 15 and lower half 17.
Each half section is formed of a material capable of withstanding
the stresses applied to the inner working compartments without
deformation or compromise of precision. A polycarbonate material
such as LEXAN brand material marketed by General Electric
Corporation has been found to satisfy the requisite strength and
deformation requirements. Other suitable materials may be used. If
desired, the cartridge can be constructed to be removable from the
handle.
The lower housing half section 17 includes upstanding tabs 17a and
the upper housing half section 15 includes correspondingly
positioned slots (not shown) which are configured and dimensioned
to receive tabs 17a such that the two half sections may be attached
by ultrasonic welding techniques. Preferably, the slots are
dimensioned to receive the tabs 17a in interference relation to
assist securement of the half portions together. Alternatively, the
half sections may be adhesively attached. Further, upper half
section 15 includes longitudinally extending slots 15a which
receive correspondingly dimensioned ribs in the collar of the
handle section to facilitate rotation of the endoscopic section
with the collar. Referring once again to FIG. 2, a plurality of
U-shaped latchless clips 22 are positioned within the housing for
movement in the distal direction in preparation for the clamping
procedures. The clips 22 are aligned in a row as shown, with the
leg portions facing distally. A jaw blade 26 is positioned at the
distal end and includes a pair of jaws 24 for reception of each
clip. Although the clips 22 are resilient and automatically snap
back into a closed position after being released from an open
position, it should be remembered that during use the clips will
have body tissue positioned between the clamping surfaces of the
legs. Therefore, it is desirable to provide additional closing
force to facilitate complete clamping of the body tissue by the
clip. This additional force is applied to the outer edges of the
clip legs by jaws 24.
One feature of the present invention is to bias the surgical clips
toward the distal direction and to sequentially advance each clip
into the jaws after the jaws have been positioned about an artery.
Thereafter, the jaws are closed and both legs of the "U" shaped
clip are brought together to sufficiently close the artery as shown
in FIGS. 11, 12, and 16.
The jaw blade 26 is fabricated of a material having sufficient
resilience such that clamping of the distal pair of jaws 24 toward
each other to close a clip therebetween will be followed by return
of the jaws to their original position upon release of the clamping
forces. Stainless steel has been found to be a preferred material
capable not only of withstanding the requisite number of clamping
cycles without adverse effect, but also of being suitably
sterilized. Furthermore, jaw blade 26 includes one or more square
shaped apertures 28 dimensioned to receive three correspondingly
shaped pins 30 molded into the lower body half section 17 of the
housing to position the jaw blade 26 with respect to the body.
Referring further to FIG. 2, crimping channel 32 is dimensioned and
positioned for slidable movement within the body of the housing and
has upraised side walls 34 along the sides and further has a slot
36 at the distal end for reception of square pins 30. The width of
the slot 36 of crimping channel 32 is sufficient to receive the
pins 30 to maintain relative alignment between the jaw blade 26 and
the pins 30. A channel bracket 38, also preferably of stainless
steel, is positioned atop the jaw blade and defines two downwardly
extending side walls 40, 42 positioned to be welded to the distal
portions of correspondingly positioned and dimensioned upwardly
extending side walls 34 of crimping channel 32. It will be
appreciated that the crimping channel 32 forms with channel bracket
38, a rectangular slidable housing surrounding the jaws 24 of jaw
blade 26. Moreover, since the jaw members 24 are formed of
outwardly tapered side walls having camming surfaces 50, 52, distal
movement of the crimping channel 32 will cause inward movement of
the jaw members, while proximal movement of the crimping channel
will result in corresponding proximal movement of channel bracket
38 thereby relieving the jaw members 24 of the crimping forces and
permitting the jaw members to resiliently open.
Referring now to FIGS. 2 and 3, jaw members 24 include inner edges
54, 56 dimensioned to receive a clip 22 therebetween for clipping a
body portion. Tissue stop plate 60 shown in FIG. 2, is positioned
between jaw blade 26 and crimping channel 32 and includes aperture
62 at the proximal end portion for reception of an appropriate pin
(not shown) which extends through the jaw blade 26 and tissue stop
plate 60 to maintain alignment of the jaw blade 26 and the tissue
stop plate 60 when these components are welded together. At the
distal portion of the tissue stop plate a tab 64 is oriented at
approximately the same downward angle as the jaws 24 for alignment
therewith arid includes an arcuate cut-out portion as shown,
dimensioned to snugly receive an artery for locating and
positioning the artery in the precise area within the jaw blades as
required for applying a clip to the artery with predetermined
precision. The tissue stop plate is preferably fabricated of a thin
stainless steel sheet material.
Support plate 57 is positioned underneath the tissue stop plate 60
and includes an upwardly bending distal section 58 which supports
the tab 64 at the distal end of tissue stop plate 60, and proximal
walls 59 which extend partially around the outer edges of the jaws
24.
Referring further to FIG. 2, track member 66 is appropriately
dimensioned to rest atop the clip clamping mechanism described
hereinabove, and supports the row of clips 22. Proximally of clips
22 is positioned a clip follower 68 which is "U" shaped at the
distal end to snugly engage and advance the clips under the action
of clip feed spring 72, the distal end of which is connected to the
proximal end of clip follower 68 and the proximal end of which is
mounted to pin 74. Pin 74 is in turn connected to pusher bar
support 76 while clip pusher bar 78 is positioned for slidable
movement thereon between a proximal position and a distal-most
position. Clip pusher 78 includes forked nose section 80 and a
depending catch 87 (see FIGS. 6 and 8) for engaging the upright
rear post 48 of the clip. When upright rear post 48 of the next
clip 22 is engaged by catch 87 in the distal nose 80 of clip pusher
78, distal movement of the clip pusher 78 advances the clip between
the edges 54, 56 of jaws 24 which engage slots 47 along the sides
of the clip 22. As clip 22 advances, lower spreader posts 49b cam
against the distal wedge surfaces 67a and 67b of spreader portion
67 of track 66. This action forces open clip legs 44 from an
initially closed position to an open position. When the clip moves
beyond the distal edge of the spreader portion 67 of the track 66
the lower spreader posts 49b no longer contact the distal wedge
surfaces 67a and 67b, thereby permitting the clip legs to close.
The clip legs close due to the resilience of the material from
which the clip is fabricated with the assistance of the closing
force applied by jaws 24.
When all the clips have been applied, clip follower 68 advances to
ridges 67c of track member 66. Slots 84 on the sides of the distal
portion 70 of clip follower 68 engage ridges 67c and the follower
distal portion 70 is stopped when stopping shoulder 82 abuts the
proximal edge of ridges 67c.
Referring again to FIG. 2, by sliding clip pusher bar 78 between
the proximal and distal positions, the clip pusher bar may be
alternately positioned with nose 80 behind each successive clip,
and thereafter advancing the clip into the jaws 24 of jaw blade 26
by pusher mechanism in handle section 12 which will be described.
The connection between the mechanism in the handle 12 is made with
the proximal end portion 90 of clip pusher 78 which extends into
the handle section. Further, the connection between the appropriate
link of handle 12 with the crimping mechanism of jaw blades 24 is
made with the proximal end portion 92 of crimping channel 32 as
will be described. The precise action of the handle 12 and its
inner mechanism is such that proximal force applied to trigger 16
causes clip pusher 78 to push the next clip 22 into the jaws 24
while simultaneously releasing the crimping channel 32 to the
"ready" position for crimping the clip. Next, the operator squeezes
handle 18 toward hand grip 20 which causes crimping channel 32 to
move distally to crimp the clip positioned within jaws 24, while
simultaneously moving clip pusher 18 proximally in position to push
the next clip 22 into the jaws 24. These movements are alternately
repeated until the last clip 22 is spent.
7. Operating Sequence
A. Handle Section
Referring now to FIGS. 19-22, the clip advancing and jaw squeezing
mechanisms are shown in various stages of the operation. FIG. 19 is
an elevational cross-sectional view of the handle 12 of the
apparatus, illustrating the pusher tube 134 in the proximal-most
position corresponding to the position of the pusher bar 78 shown
in FIG. 4, i.e., with the nose 80 just proximal of the next clip 22
in readiness to advance the clip distally into the jaws 24.
Additionally, with pusher tube in the proximal position, downwardly
extending pin 158 has moved out of engagement with latch 150
thereby permitting tongue 156 to enter the aperture of channel
latch plate 146 thus preventing any distal movement of channel tube
124. This condition locks handle 18 in the distal position whereby
squeezing the handle toward hand grip 20 is prevented.
Referring now to FIG. 20, there is shown a cross-sectional view of
the handle 12 of the apparatus with the pusher tube in the
distal-most position corresponding to the position of pusher bar 78
as shown in FIG. 10, i.e., with the clip 22 advanced distally into
the jaws 24 of jaw blade 26 As can be seen further in FIG. 20, the
distal position of pusher tube 134 has now resulted in release of
tongue 156 of latch plate 150 from the aperture of channel latch
plate 146 in the bottom wall of channel tube 124 thereby permitting
advancement of channel tube 124 and crimping channel 32 distally to
squeeze jaws 24 in conjunction with channel bracket 38.
Referring now to FIG. 21, a cross-sectional view of the handle 12
is shown after the crimping action has taken place on clip 22
positioned within jaws 24. The position of the components shown in
FIG. 21 corresponds to the position of the jaws shown in FIG. 11,
i.e., in the clamped position about clip 22. In the cross-section
shown in FIG. 21, the pusher tube 134 is in the proximal-most
position and the channel tube is in the distal-most position such
that crimping channel 32 and channel bracket 40 are in the
distal-most position.
Referring to FIG. 22, a cross-sectional view of the handle 20 is
shown after the last clip 22 has been spent.
Referring once again to FIG. 18 in conjunction with FIGS. 19-22,
lost motion spring 210 is shown having transverse arms 212 and tab
214. Spring 210 provides bias force on pusher links 120, 122 such
that squeezing action on handle 18 maximizes proximal movement of
pusher tube 134. Thus, partially closing the jaws 24 of jaw blade
26 will cause pusher tube 134 to move sufficiently proximal to make
certain that pusher bar 78 has moved proximally of the next clip
22. Without such movement it may be possible for the surgeon to
squeeze the jaws, not fully appreciating that the pusher bar 78 has
not moved to a position proximal of the next clip 22. This proximal
movement of the pusher bar is thus assisted by lost motion spring
210 which maximizes the repositioning movement of the pusher bar 78
behind the next clip whether the jaws are squeezed fully or
partially. In particular, the proximal bias provided by spring 210
on pusher links 120, 122 maximizes the movement of the pusher tube
134 in relation to the movement of handle 18 by maintaining pusher
links: 120, 122 in their proximal-most positions prior to squeezing
the handle 18. This maximum proximal movement of pusher links 120,
122 in turn results in proximal movement of pusher tube sufficient
to engage tongue 162 of release spring 160 thus making certain that
pusher bar 178 is repositioned sufficiently proximally to advance
the next clip 22 into the jaw members 24.
B. The Endoscopic Portion
Referring now to FIGS. 3 to 10, the operation of the endoscopic
portion of the instrument is shown. More particularly, FIGS. 3 and
4 illustrate the initial condition of the instrument. The latchless
clip follower 68, biased by spring 72, urges latchless clips 22
distally. Clip pusher 78 with forked nose 80 and catch 87 is
positioned proximal to the distal-most clip. Tissue 200 to be
clipped is located between jaws 24 and abuts tab 64 of tissue stop
60. The distal end 67 of clip track 68 possesses inclined camming
surfaces 67a and 67b for contacting the upright leg posts 49 of the
latchless clip 22. A central alignment slot 67d receives
depending
alignment post 43 of the latchless clip 22 and maintains the clip
in alignment as it is advanced distally. FIG. 13 shows a sectional
view of the distal portion of the apparatus as indicated.
Referring now to FIGS. 5 and 6, as the clip 22 is advanced,
spreader leg posts 49b cam against surfaces 67a and 67b thereby
opening legs 44 of the clip 22. Depending alignment post 43 rides
in slot 67d.
As shown in FIGS. 7, 8, and 14, clip 22 is advanced further and the
clip legs 44 are fully opened. The clip begins to enter the jaws 24
and the edges 54 and 56 of the jaws engage side slots 47 of the
clip to maintain proper alignment. Clip 22 is advanced fully into
the jaws 24 and is positioned for application to tissue 200 as
shown in FIGS. 9 and 10.
Referring now to FIGS. 11 and 12, the clip closing mechanism is
activated, as explained above, and jaws 24 of the instrument are
closed, thereby closing latchless clip 22 around tissue 200, as
illustrated in FIG. 15. The latchless clip 22 remains closed.
Hence, when the jaws 24 reopen, clip 22 is released from the jaws
24.
An illustrative example of an operation which may be performed
endoscopically on body tissue is shown in FIG. 17, wherein clip
applier 10 applies a series of latchless clips 22 to body tissue
200.
* * * * *