U.S. patent application number 12/633928 was filed with the patent office on 2010-04-08 for anastomosis instrument and method for performing same.
This patent application is currently assigned to United States Surgical Corporation. Invention is credited to Peter Hinchliffe, Scott E. Manzo, Keith Milliman, David A. Nicholas, Kevin Sniffen.
Application Number | 20100087841 12/633928 |
Document ID | / |
Family ID | 27500562 |
Filed Date | 2010-04-08 |
United States Patent
Application |
20100087841 |
Kind Code |
A1 |
Milliman; Keith ; et
al. |
April 8, 2010 |
ANASTOMOSIS INSTRUMENT AND METHOD FOR PERFORMING SAME
Abstract
A surgical instrument for anastomosis of first and second blood
vessels is provided. The surgical instrument includes a housing
having distal and proximal ends and a handle and a disposable
loading unit removably mounted to the distal end of the housing.
The housing includes upper and lower fastener support members
having a passage defined therethrough configured to receive an end
of the second blood vessel and configured to releasably support a
plurality of substantially L-shaped surgical fasteners and a
retractable anvil located at a distal end of the loading unit, the
anvil being movable relative to the fastener support members in
response to actuation of the handle to simultaneously deform the
surgical fasteners.
Inventors: |
Milliman; Keith; (Bethel,
CT) ; Sniffen; Kevin; (Danbury, CT) ;
Nicholas; David A.; (Trumbull, CT) ; Manzo; Scott
E.; (Shelton, CT) ; Hinchliffe; Peter; (New
Haven, CT) |
Correspondence
Address: |
Tyco Healthcare Group LP
60 MIDDLETOWN AVENUE
NORTH HAVEN
CT
06473
US
|
Assignee: |
United States Surgical
Corporation
North Haven
CT
|
Family ID: |
27500562 |
Appl. No.: |
12/633928 |
Filed: |
December 9, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11429583 |
May 5, 2006 |
7635385 |
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12633928 |
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10388969 |
Mar 13, 2003 |
7204843 |
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11429583 |
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09882245 |
Jun 14, 2001 |
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10388969 |
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09410817 |
Oct 1, 1999 |
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09882245 |
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09256260 |
Feb 23, 1999 |
6083234 |
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09410817 |
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08877701 |
Jun 17, 1997 |
6024748 |
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09256260 |
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08685385 |
Jul 23, 1996 |
5707380 |
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08877701 |
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Current U.S.
Class: |
606/153 |
Current CPC
Class: |
A61B 17/0293 20130101;
A61B 2017/2916 20130101; A61B 17/1152 20130101; A61B 17/083
20130101; A61B 17/08 20130101; A61B 17/122 20130101; A61B 2017/1135
20130101; A61B 17/11 20130101; A61B 2017/1107 20130101; A61B
17/1285 20130101 |
Class at
Publication: |
606/153 |
International
Class: |
A61B 17/11 20060101
A61B017/11 |
Claims
1. A surgical instrument for anastomosis of first and second blood
vessels, comprising: a housing having distal and proximal ends and
a handle; a disposable loading unit removably mounted to the distal
end of the housing having: upper and lower fastener support members
having a passage defined therethrough configured to receive an end
of the second blood vessel and configured to releasably support a
plurality of substantially L-shaped surgical fasteners; and a
retractable anvil located at a distal end of the loading unit, the
anvil being movable relative to the fastener support members in
response to actuation of the handle to simultaneously deform the
surgical fasteners.
2. A surgical instrument according to claim 1 wherein the loading
unit further comprises a first retracting sleeve which moves the
anvil in response to actuation of the handle.
3. A surgical instrument according to claim 1 wherein the fastener
support member supports the fasteners in an array-like manner.
4. The surgical instrument according to claim 1 wherein the distal
end of the first sleeve includes a plurality of elongated channels
which support the surgical fasteners.
5. The surgical instrument according to claim 4 wherein each of the
channels includes a distal and proximal end wherein each distal end
is radially offset from the proximal end such that the proximal and
distal ends of the surgical fasteners are supported in a radially
offset manner.
6. A surgical instrument according to claim 1 wherein the anvil has
an angled surface such that the distal ends of the surgical
fasteners deform proximally upon actuation of the handle.
7. A surgical instrument according to claim 4 further comprising: a
second retracting sleeve which releasably retains the surgical
fasteners within the elongated channels of the first retracting
sleeve.
8. A surgical instrument according to claim 1 wherein the loading
unit further comprises a second retracting sleeve which moves in
response to actuation of the handle.
9. A surgical instrument according to claim 8 wherein continued
movement of the handle moves the second retracting sleeve relative
to the first retracting sleeve.
10. A surgical instrument according to claim 9 wherein movement of
the second retracting sleeve relative to the first retracting
sleeve releases the surgical fasteners.
11. A surgical instrument according to claim 8 wherein the second
retracting sleeve includes a plurality of fingers which releasably
retain the surgical fasteners against the anvil.
12. A surgical instrument according to claim 1 further comprising:
an actuator which moves the first and second retracting sleeves in
response to movement of the handle.
13. A surgical instrument according to claim 12 wherein the
actuator includes a cam.
14. A surgical instrument according to claim 13 wherein the cam
includes more than one cam follower.
15. A surgical instrument according to claim 13 wherein the cam
includes multiple stages.
16. A surgical instrument for anastomosis of first and second blood
vessels, comprising: a housing having an actuator; and a disposable
loading unit removably mounted to the housing, the disposable
loading unit having: a fastener support member configured to
releasably support a plurality of substantially L-shaped surgical
fasteners; and a retractable anvil being movable relative to the
fastener support member in response to the actuator to
simultaneously deform the surgical fasteners.
17. A surgical instrument according to claim 16 wherein the
fastener support member supports the fasteners in an array-like
manner.
18. A surgical instrument according to claim 16 wherein each of the
fasteners includes a distal and proximal end and the fastener
support member supports the distal and proximal ends of each
fastener in a radially offset manner.
19. A surgical instrument according to claim 16 wherein the anvil
has an angled surface such that a distal end of each surgical
fastener deforms proximally in response to the actuator.
20. A surgical instrument according to claim 16 wherein the loading
unit further comprises: a first retracting sleeve which moves the
anvil in response to the actuator.
21. A surgical instrument according to claim 20 wherein the first
retracting sleeve includes a plurality of elongated channels which
support the surgical fasteners.
22. A surgical instrument according to claim 20 wherein the loading
unit includes a second retracting sleeve which is movable in
response to the actuator.
23. A surgical instrument according to claim 22 wherein continued
movement of the actuator moves the second retracting sleeve
relative to the first retracting sleeve.
24. A surgical instrument according to claim 23 wherein movement of
the second retracting sleeve relative to the first retracting
sleeve releases the surgical fasteners.
25. A surgical instrument according to claim 16 wherein the
actuator includes a cam.
26. A surgical instrument according to claim 25 wherein the cam
includes more than one cam follower.
27. A surgical instrument according to claim 25 wherein the cam
includes multiple stages.
28. The surgical instrument according to claim 16 wherein the
loading unit includes two halves which are pivotable relative to
one another.
29. The surgical instrument according to claim 28 wherein the two
halves of the loading unit when closed form an elongated aperture
which receives the second vessel therethrough.
30. The surgical instrument according to claim 29 wherein each half
of the loading unit includes a fastener support.
31. The surgical instrument according to claim 16 wherein the
loading unit includes a plurality of elongated channels which
support the fasteners.
32. The surgical instrument according to claim 31 wherein each
elongated channel includes a distal end and a proximal end which is
radially offset relative to the distal end.
33. The surgical instrument according to claim 16 wherein the
loading unit includes a first plurality of channels and a second
plurality channels and wherein each channel of the first plurality
of channels is configured to support a distal end of each fastener
and a corresponding channel of the second plurality of channels is
configured to support a proximal end of each fastener.
34. The surgical instrument according to claim 33 wherein the first
plurality of channels is disposed substantially perpendicularly to
the second plurality of channels.
35. The surgical instrument according to claim 1, wherein the
substantially L-shaped fasteners have a base leg, a support leg and
a convexity projecting from the support leg in the direction of the
base leg.
36. The surgical instrument according to claim 35, wherein the
upper and lower fastener support members and retractable anvil are
arranged so that when the anvil is retracted, the fasteners are
deformed with the convexity of each fastener cooperating with the
base leg to retain the blood vessels.
37. The surgical instrument according to claim 16, wherein the
substantially L-shaped fasteners have a base leg, a support leg and
a convexity projecting from the support leg in the direction of the
base leg.
38. The surgical instrument according to claim 37, wherein the
upper and lower fastener support members and retractable anvil are
arranged so that when the anvil is retracted, the fasteners are
deformed with the convexity of each fastener cooperating with the
base leg to retain the blood vessels.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 11/429,583 entitled "ANASTOMOSIS INSTRUMENT AND METHOD FOR
PERFORMING SAME" which was filed on May 5, 2006 by Milliman et al.,
which is a continuation of U.S. application Ser. No. 10/388,969
entitled "ANASTOMOSIS INSTRUMENT AND METHOD FOR PERFORMING SAME"
which was filed on Mar. 13, 2003 by Milliman et al., now U.S. Pat.
No. 7,204,843, which is a continuation of U.S. application Ser. No.
09/882,245 entitled "ANASTOMOSIS INSTRUMENT AND METHOD FOR
PERFORMING SAME" which was filed on Jun. 14, 2001 by Milliman et
al., now abandoned, which is a continuation of U.S. application
Ser. No. 09/410,817, entitled "ANASTOMOSIS INSTRUMENT AND METHOD
FOR PERFORMING SAME" which was filed on Oct. 1, 1999 by Milliman et
al., now abandoned, which is a continuation-in-part of U.S.
application Ser. No. 09/256,260, entitled "ANASTOMOSIS INSTRUMENT
AND METHOD" which was filed on Feb. 23, 1999 by Nicholas et al.,
now U.S. Pat. No. 6,083,234, which is a continuation-in-part of
U.S. application Ser. No. 08/877,701 entitled "SINGLESHOT
ANASTOMOSIS INSTRUMENT WITH DETACHABLE LOADING UNIT AND METHOD",
which was filed on Jun. 17, 1997 by Manzo et al., now U.S. Pat. No.
6,024,748, which is a continuation-in-part of U.S. application Ser.
No. 08/685,385, entitled "ANASTOMOSIS INSTRUMENT AND METHOD", filed
on Jul. 23, 1996 by Hinchliffe et al., now U.S. Pat. No. 5,707,380.
U.S. application Ser. No. 10/388,969, now issued as U.S. Pat. No.
7,204,843, U.S. application Ser. No. 09/256,260, now issued as U.S.
Pat. No. 6,083,234, U.S. application Ser. No. 08/877,701, now
issued as U.S. Pat. No. 6,024,748, as well as U.S. application Ser.
No. 08/685,385, now issued as U.S. Pat. No. 5,707,380, are all
herein incorporated by reference in their entirety.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates to a surgical instrument and
method for performing anastomosis of tubular body structures, and
more particularly to an instrument for joining vascular tissues,
for example, during coronary artery bypass graft procedures.
[0004] 2. Background of Related Art
[0005] Coronary artery disease is often characterized by lesions or
occlusions in the coronary arteries which may result in inadequate
blood flow to the myocardium, or myocardial ischemia, which is
typically responsible for such complications as angina pectoris,
necrosis of cardiac tissue (myocardial infarction), and sudden
death. In some cases, coronary artery disease may be treated by the
use of drugs and/or by modifications in behavior and diet. In other
cases, dilatation of coronary arteries may be achieved by such
procedures as angioplasty, laser ablation, atherectomy,
catheterization, and intravascular stents.
[0006] For certain patients, a coronary artery bypass graft
("CABG") is the preferred form of treatment to relieve symptoms and
the graft often increases life expectancy. A CABG procedure
consists of direct anastomosis of a vessel segment to one or more
of the coronary arteries. For example, a reversed segment of the
saphenous vein may be grafted at one end to the ascending aorta as
an arterial blood source and at the other end to a coronary artery
at a point beyond the arterial occlusion. Alternatively, the
internal mammary artery ("saphenous vein") located in the thoracic
cavity adjacent the sternum is likewise suitable for grafting to a
coronary artery, such as the left anterior descending artery
("LAD").
[0007] The performance of a CABG procedure typically requires
access to the heart, blood vessels and associated tissue. Access to
the patient's thoracic cavity may be achieved in an open procedure
by making a large longitudinal incision in the chest. This
procedure, referred to as a median sternotomy, requires a saw or
other cutting instrument to cut the sternum to allow the two
opposing halves of the rib cages to be spread apart to expose the
internal organs of the thoracic cavity.
[0008] U.S. Pat. No. 5,025,779 to Bugge discloses a retractor which
is designed to grip opposite sternum halves and spread the thoracic
cavity apart. The large opening which is created by this technique
enables the surgeon to directly visualize the surgical site and
perform procedures on the affected organs. However, such procedures
that involve large incisions and substantial displacement of the
rib cage are often traumatic to the patient with significant
attendant risks. The recovery period may be extensive and is often
painful. Furthermore, patients for whom coronary surgery is
indicated may need to forego such surgery due to the risks involved
with gaining access to the heart.
[0009] U.S. Pat. No. 5,503,617 to Jako discloses a retractor
configured to be held by the surgeon for use in vascular or cardiac
surgery to retract and hold ribs apart to allow access to the heart
or a lung through an operating "window". The retractor includes a
rigid frame and a translation frame slideably connected to the
rigid frame. Lower and upper blades are rotatably mounted to the
rigid frame and the translation frame respectively. The "window"
approach enables the surgeon to gain access through a smaller
incision and with less displacement of the ribs, and consequently,
less trauma to the patient.
[0010] Once access to the thoracic cavity has been achieved,
surgery on the heart may be performed. Such procedures typically
require that the heartbeat be arrested while maintaining
circulation throughout the rest of the body. Cardioplegic fluid,
such as potassium chloride (KCI) is delivered to the blood vessels
of the heart to paralyze the myocardium. As disclosed in WO
95/15715 to Sterman et al. for example, cardioplegic fluid is
infused into the myocardium through the coronary arteries by a
catheter inserted into the ascending aorta.
[0011] Alternatively, cardioplegic fluid is infused through the
coronary veins in a retrograde manner by a catheter positioned in
the interior jugular vein accessed at the patient's neck. Such
procedures require the introduction of multiple catheters into the
blood vessels adjacent the heart, which is a complicated procedure
requiring that the desired vessels be properly located and
accessed. The progression of the guide wires and catheters must be
closely monitored to determine proper placement. Furthermore, the
introduction of catheters form punctures in the blood vessels that
must be subsequently closed, and there is an increased risk of
trauma to the interior walls of the vessels in which the catheters
must pass.
[0012] Alternatively, the CABG procedure may be performed while the
heart is permitted to beat. Such a procedure is now commonly
referred to as minimally invasive direct coronary artery bypass
(MIDCAB) when performed through a thoracotomy (when performed
through a sternotomy, the procedure is commonly called open
coronary artery bypass (OP-CAB). A surgical instrument is used to
stabilize the heart and restrict blood flow through the coronary
artery during the graft procedure. Special care must be given to
procedures performed on a beating heart, e.g. synchronizing
procedures to occur at certain stages in the cardiac cycle, such as
between heartbeats.
[0013] To perform a CABG procedure, the harvested vessel segment,
such as the saphenous vein, is grafted to the coronary artery by
end-to-side anastomosis. Typically, sutures are used to graft the
vessel segments. However, conventional suturing is complicated by
the use of minimally invasive procedures, such as the window
approach, e.g., limited access and reduced visibility to the
surgical site may impede the surgeon's ability to manually apply
sutures to a graft. Additionally, it is difficult and time
consuming to manually suture if the CABG procedure is being
performed while the heart is beating as the suturing must be
synchronized with the heart beat.
[0014] As can be appreciated, the process of manually suturing the
harvested vessel segment to a coronary artery is time consuming and
requires a great deal of skill on the part of the surgeon. The
resulting sutured anastomosis will also be dependent on the skills
of the surgeon. In minimally invasive procedures such as in MIDCAB,
the ability to suture is even more complicated due to limited
maneuverability and reduced visibility. U.S. Pat. No. 5,707,380 to
Hinchliffe et al., the entire contents of which are hereby
incorporated by reference, discloses an apparatus and a procedure
that enable remote anastomosis without piercing of vessels during
both conventional and minimally invasive procedures. A continuing
need exists, however, for improved surgical instruments and methods
for performing remote anastomoses during both conventional and
minimally invasive procedures.
SUMMARY
[0015] Accordingly, a surgical instrument for anastomosis of first
and second blood vessels is provided. The surgical instrument
includes a housing having distal and proximal ends and a handle and
a disposable loading unit removably mounted to the distal end of
the housing. The housing includes upper and lower fastener support
members having a passage defined therethrough configured to receive
an end of the second blood vessel and configured to releasably
support a plurality of substantially L-shaped surgical fasteners
and a retractable anvil located at a distal end of the loading
unit, the anvil being movable relative to the fastener support
members in response to actuation of the handle to simultaneously
deform the surgical fasteners.
[0016] In one embodiment, the loading unit further comprises a
first retracting sleeve which moves the anvil in response to
actuation of the handle. The fastener support member may support
the fasteners in an array-like manner. The distal end of the first
sleeve may include a plurality of elongated channels which support
the surgical fasteners. Each of the channels may include a distal
and proximal end wherein each distal end is radially offset from
the proximal end such that the proximal and distal ends of the
surgical fasteners are supported in a radially offset manner. The
anvil may include an angled surface such that the distal ends of
the surgical fasteners deform proximally upon actuation of the
handle.
[0017] In another embodiment, the surgical instrument may further
include a second retracting sleeve which releasably retains the
surgical fasteners within the elongated channels of the first
retracting sleeve. The loading unit may further include a second
retracting sleeve which moves in response to actuation of the
handle. Continued movement of the handle may move the second
retracting sleeve relative to the first retracting sleeve. Movement
of the second retracting sleeve relative to the first retracting
sleeve may release the surgical fasteners. The second retracting
sleeve may include a plurality of fingers which releasably retain
the surgical fasteners against the anvil. The surgical instrument
may further include an actuator which moves the first and second
retracting sleeves in response to movement of the handle. The
actuator may include a cam. The cam may include more than one cam
follower. The cam may include multiple stages.
[0018] In another embodiment, a surgical instrument for anastomosis
of first and second blood vessels includes a housing having an
actuator and a disposable loading unit removably mounted to the
housing, the disposable loading unit. The disposable loading unit
may include a fastener support member configured to releasably
support a plurality of substantially L-shaped surgical fasteners
and a retractable anvil being movable relative to the fastener
support member in response to the actuator to simultaneously deform
the surgical fasteners. The fastener support member may support the
fasteners in an array-like manner. Each of the fasteners may
include a distal and proximal end and the fastener support member
supports the distal and proximal ends of each fastener in a
radially offset manner. The anvil may have an angled surface such
that a distal end of each surgical fastener deforms proximally in
response to the actuator. The loading unit may further include a
first retracting sleeve which moves the anvil in response to the
actuator. The first retracting sleeve may include a plurality of
elongated channels which support the surgical fasteners. The
loading unit may include a second retracting sleeve which is
movable in response to the actuator. Continued movement of the
actuator may move the second retracting sleeve relative to the
first retracting sleeve. Movement of the second retracting sleeve
relative to the first retracting sleeve may cause the release the
surgical fasteners. The actuator may include a cam. The cam may
include more than one cam follower. The cam may include multiple
stages.
[0019] In one embodiment, the loading unit may include two halves
which are pivotable relative to one another. The two halves of the
loading unit when closed may form an elongated aperture which
receives the second vessel therethrough. Each half of the loading
unit includes a fastener support. The loading unit may include a
plurality of elongated channels which support the fasteners. Each
elongated channel may include a distal end and a proximal end which
is radially offset relative to the distal end.
[0020] Additionally, the loading unit may include a first plurality
of channels and a second plurality channels and wherein each
channel of the first plurality of channels is configured to support
a distal end of each fastener and a corresponding channel of the
second plurality of channels is configured to support a proximal
end of each fastener. The first plurality of channels may be
disposed substantially perpendicularly to the second plurality of
channels. The substantially L-shaped fasteners may include a base
leg, a support leg and a convexity projecting from the support leg
in the direction of the base leg. The upper and lower fastener
support members and retractable anvil may be arranged so that when
the anvil is retracted, the fasteners are deformed with the
convexity of each fastener cooperating with the base leg to retain
the blood vessels. The substantially L-shaped fasteners may have a
base leg, a support leg and a convexity projecting from the support
leg in the direction of the base leg. The upper and lower fastener
support members and retractable anvil may be are arranged so that
when the anvil is retracted, the fasteners are deformed with the
convexity of each fastener cooperating with the base leg to retain
the blood vessels.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] Other objects and features of the present invention will
become apparent from the following detailed description considered
in connection with the accompanied drawings. It should be
understood, however, that the drawings are designed for the purpose
of illustration only and not as a definition of the limits of the
invention.
[0022] An illustrative embodiment of the subject surgical
instrument and method are described herein with reference to the
drawings wherein:
[0023] FIG. 1 is a perspective view of a surgical instrument
constructed in accordance with a preferred embodiment of the
present disclosure;
[0024] FIG. 2 is an enlarged, partial perspective view of a single
use loading unit (hereinafter "SULU") constructed in accordance
with a preferred embodiment of the present disclosure;
[0025] FIG. 2A is an enlarged, perspective view of the indicated
area of detail of FIG. 2;
[0026] FIG. 3 is a perspective view of a surgical fastener which is
designed for operative engagement with the SULU for creating
vascular anastomosis between two luminal vessels;
[0027] FIG. 4 is a side view the surgical instrument of FIG. 1;
[0028] FIG. 4A is a left, side view of a handle/actuator assembly
of the surgical instrument of FIG. 1 shown without a cover plate
attached thereto;
[0029] FIG. 5 is an enlarged, perspective view of a distal end of
the actuator assembly shown in a pre-loading position to
receivingly engage the SULU;
[0030] FIG. 6 is a reverse, perspective view of the SULU of FIG.
2;
[0031] FIG. 6A is a reverse, perspective view of a lower half of
the SULU of FIG. 2;
[0032] FIG. 7 is a perspective view with parts separated of the
SULU of FIG. 2;
[0033] FIG. 7A is a greatly enlarged, perspective view of the
indicated area of detail of FIG. 7;
[0034] FIG. 7B is a greatly enlarged, perspective view of the
indicated area of detail of FIG. 7;
[0035] FIG. 7C is an enlarged, perspective view of a base portion
of a first retracting sleeve;
[0036] FIG. 7D is a greatly enlarged, perspective view of the
indicated area of detail of FIG. 7C;
[0037] FIG. 8 is a greatly enlarged, perspective view of the
indicated area of detail of FIG. 7;
[0038] FIG. 9 is a greatly enlarged, perspective view of the
indicated area of detail of FIG. 7;
[0039] FIG. 10 is a perspective view of the actuator assembly with
the cover plate shown separated;
[0040] FIG. 11 is a perspective view the actuator assembly of FIG.
10 shown with parts separated;
[0041] FIG. 12 is a horizontal cross-sectional view of the surgical
instrument of FIG. 1 shown loaded for firing;
[0042] FIG. 13 is a horizontal cross-sectional view of the
indicated area of detail of FIG. 12;
[0043] FIG. 13A is a greatly enlarged horizontal cross sectional
view of the area indicated in detail of FIG. 13;
[0044] FIG. 14 is a top cross-sectional view of the surgical
instrument taken along section line 14-14 of FIG. 12;
[0045] FIG. 15 is a greatly enlarged top cross-sectional view of
the area indicated in detail of FIG. 14;
[0046] FIG. 16 is a front cross-sectional view of the surgical
instrument taken along section line 16-16 of FIG. 12;
[0047] FIG. 17 is a perspective view of the SULU with a first
vessel inserted therethrough;
[0048] FIG. 18 is perspective of the SULU with an end of the first
vessel everted over a distal end of the disposable unit being
inserted into an incision in a second vessel;
[0049] FIG. 19 is an internal, perspective view of the second
vessel with the SULU and the everted first vessel shown inserted
therein;
[0050] FIG. 20 is a side cross-sectional view of the SULU and the
everted first vessel shown inserted within the second vessel in
pre-firing position;
[0051] FIG. 21 is a side view of the actuator assembly without the
cover plate during a first firing stage of the instrument and
showing the internal movement of a first retractor within the
actuator assembly;
[0052] FIG. 21A is a side cross-sectional view showing the relevant
positions of the internal working components of the actuator
assembly after the first firing stage;
[0053] FIG. 21B is a side cross-sectional view showing the movement
of the SULU during the first firing stage to deform the surgical
fasteners;
[0054] FIG. 21C is a greatly enlarged side cross-sectional view of
the area indicated in detail in FIG. 21B;
[0055] FIG. 21D is a greatly enlarged perspective view of the
surgical fastener shown in a "stapled" configuration;
[0056] FIG. 21E is a side view showing the relevant movement of a
locking sleeve after the first firing stage;
[0057] FIG. 22 is a side cross-sectional view of the actuator
assembly during the second firing stage and showing the internal
movement of a second retractor within the actuator assembly;
[0058] FIG. 22A is a side cross-sectional view of the SULU during
the second firing stage and showing the movement of a second
retracting sleeve which moves as a direct result of the movement of
the second retractor to release the surgical fasteners;
[0059] FIG. 22B is a greatly enlarged side cross-sectional view
showing the retracting movement of a finger-like retention prong
which moves as a direct result of the movement of the second
retractor;
[0060] FIG. 23 is a perspective view of the SULU showing the
pivotable movement of the two supports which open after firing to
release the first vessel;
[0061] FIG. 24 is a view showing a completed anastomosis;
[0062] FIG. 25 is a view showing an operating "window" with the
patient's heart exposed;
[0063] FIG. 26A is a view showing the surgical fastener staple
pattern of the instrument described with respect to FIGS. 1-26;
and
[0064] FIG. 26B. is a view showing one possible alternative
surgical fastener staple pattern.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0065] Preferred embodiments of the surgical instrument and method
disclosed herein will be described in terms of a coronary artery
bypass procedure wherein a vascular anastomosis is created by
joining a section of a harvested vessel, e.g., the saphenous vein,
to bypass an occlusion in a coronary artery, e.g., the left
anterior descending artery ("LAD") and/or aorta. Alternatively, the
presently disclosed surgical instrument may also be utilized in
performing anastomosis of other tubular luminal body
structures.
[0066] In the drawings and in the description which follows, the
term "proximal", as is traditional, will refer to the end of the
apparatus which is closer to the user, while the term "distal" will
refer to the end which is further from the user.
[0067] Referring now in detail to the drawing figures in which like
reference numerals identify similar or identical elements, one
embodiment of the present disclosure is illustrated generally in
FIG. 1 and is designated therein as surgical instrument 10.
Surgical instrument 10 includes two principal components, namely,
an actuator assembly 20 and a disposable loading unit ("DLU") or a
single use loading unit ("SULU") 100, which along with their
internal working components, mechanically cooperate to deform a
surgical fastener 260 to complete an anastomosis between two
vessels, e.g., an saphenous vein 320 and an LAD and/or aorta 310
(FIG. 21B).
[0068] The particular surgical instrument 10 shown in the various
figures is preferably designed to deform an array of surgical
fasteners similar to fastener 260 shown in FIG. 3 which is
generally L-shaped and includes a base leg 264 and an upwardly
extending support leg 262. Preferably, base leg 264 includes a
distal end 269 which is sufficiently shaped to penetrate the
saphenous vein 320 and the LAD and/or aorta 310 upon deformation of
the surgical fastener 260. The upwardly extending support leg 262
is attached to base leg 264 at a pivot point 265 and includes an
inwardly extending prong 267 disposed at its free end designed to
penetrate the LAD and/or aorta 310 and secure surgical fastener 260
in position after anastomosis. A convexity 263 projects inwardly
between the base leg 264 and the support leg 262 and is preferably
sufficiently dimensioned to cooperate with the base leg 264 to
retain the saphenous vein 320 against LAD and/or aorta 310 in fluid
communication after anastomosis as will be explained in greater
detail below with respect to FIGS. 216 and 24. It is envisioned
that the surgical fastener 260 can be arranged on the SULU in
different patterns/arrays depending upon a particular purpose.
[0069] As best seen in FIGS. 1, 4, 10 and 11, actuator assembly 20
includes a proximal end 24, a distal end 22 and a housing 26
defined therebetween for storing the internal working components of
the actuator assembly 20. Preferably, a plate 90 covers the
internal components of the actuator assembly 20 when assembled.
More particularly, housing 26 includes at least one mechanical
interface 23a which reciprocates with a corresponding mechanical
interface 23b (FIG. 10) disposed on cover plate 90 to matingly
engage the two components 26 and 90.
[0070] Actuator assembly 20 also includes a handle 12 which
initiates firing of the surgical instrument 10 and a spring-loaded
thumb tab 30 for loading the SULU 100 onto the actuator assembly 20
both of which will be explained in greater detail below.
Preferably, handle 12 is provided with an ergonomic surface which
is contoured and configured to be comfortably gripped by the hand
of the user during operation of the instrument.
[0071] Turning now to FIG. 11 which illustrates in detail the
internal working components of the actuating assembly 20 which are
preferably assembled and stored within housing 26. More
particularly, the actuating assembly 20 includes a torsion spring
70 which mounts about post 21 which protrudes from housing 26.
Spring 70 includes a lower arm 74 which is biased against a lower
portion of the housing and an upper arm 72 which is biased against
a rotating two-stage cam 60.
[0072] Handle 12 includes a bushing 19 which protrudes laterally
from the proximal end of the handle 12 and pivotally engages a
corresponding recess 29 disposed within the proximal end 24 of
housing 26 to allow pivotal movement of the handle 12 with respect
to housing 26. Handle 12 also includes a vertically extending slot
27 disposed at its proximal end 24 which receives the proximal end
of a lever 16 which moves in conjunction with the handle 12. A pair
of flanges 14a and 14b downwardly extend from the handle 12 and
receive lever 16 therebetween. A mechanical interface 11a disposed
on handle 12 engages a corresponding mechanical interface 11b
disposed on lever 16 to secure the lever 16 to the handle 12.
Preferably, lever 16 has a first recess 17 shaped to engage and
control the movement of the cam 60 during downward movement of the
handle 12, the purpose of which will be explained in more detail
with respect to FIG. 21A. Lever 16 also includes a second recess 15
which helps to limit lateral movement of the spring 70 within
housing 26.
[0073] As mentioned above, actuating assembly 20 also includes a
spring-loaded thumb tab 30 which rests atop housing 26 within a
longitudinally extending slot 28 disposed near the distal end 22
thereof. As best seen in FIG. 10, slot 28 is formed by notches 18a
and 18b of the housing 26 and cover plate 90, respectively. Tab 30
includes a thumb guide 35 which cooperates with a sliding sleeve 32
to facilitate proximal movement of the tab 30 for loading the SULU.
A downwardly depending flange 34 disposed on tab 30 engages a
corresponding slot 33 located in a mount 31 disposed atop the
sliding sleeve 32. Preferably, sliding sleeve 32 includes a post 36
which is dimensioned to receive a tension spring 38 thereon. Spring
38 is biased between a block 47 disposed within housing 26 and a
proximal edge 37 of sliding sleeve 32 such that spring 38 biases
sliding sleeve 32 to a distal-most position proximate distal end
22. Preferably, a distal end 39 of sleeve 32 is arcuate or
semi-circular and is dimensioned to slidingly engage a
corresponding end 82 of a first retractor 80 to lock the SULU 100
within the actuator assembly 20 after the SULU 100 is loaded as
will be discussed in more detail below.
[0074] Actuator assembly 20 also includes first retractor 80 and a
second retractor 50 which each move by way of movement of the
handle 12 which, in turn, imparts movement to the two-stage cam 60.
First retractor 80 includes distal and proximal ends 82 and 84,
respectively, and is generally tubular in dimension with the
exception of an elongated furrow 83 extending proximally from
distal end 82 for slidingly supporting sleeve 32. Retractor 80 also
includes a slot 85 for receiving a pin 54 for affixing the
retractor 80 to the cam 60 and another pair of slots 87 and 89
located near the proximal end 84 for receiving two cam followers
51a and 51b, respectively. Preferably, the proximal end 84 is
bifurcated to facilitate insertion of the second retractor 50
therein.
[0075] As best seen in FIGS. 11 and 16, a guide 81 engages an
elongated rib 25a in housing 26 and an elongated rib 25b in cover
plate 90 to slidingly mount the retractor 80 to housing 26. Guide
81 is dimensioned slightly longer than rib 25a to permit proximal
movement of the first retractor 80 relative to the housing 26 upon
activation of the handle 12. Preferably, a protective tube 95 is
telescopically disposed about the first retractor 80 and moves in
conjunction with the sliding sleeve 32 by way of slot 96 which
secures mount 31 of the sliding sleeve 32 therein. It is
anticipated that protective tube 95 also helps to restrict lateral
movement of the first retractor 80 during retraction. Tube 95 also
includes an elongated channel 97 which generally aligns with guide
81 located in the first retractor 80 to mount both components to
ribs 25a and 25b.
[0076] It is contemplated that proximal movement of tab 30 will
impart reciprocating proximal movement to the sliding sleeve 32 to
expose carriages 86 and 88 disposed within the first retractor 80
which are designed to receive a pair of first and second retracting
sleeves 110 and 120 (FIGS. 7-9) of the SULU 100. More particularly,
and as best seen in FIG. 5, carriage 86 is generally circular in
shape and is designed to receive an outer lip 122 formed by the
union of end 122a and 122b of second retracting sleeve 120 of the
SULU 100. Preferably, carriage 86 is dimensioned larger that the
lip 122 so as to permit proximal movement of the second retracting
sleeve 120 relative to the first retracting sleeve 110 as will be
explained in more detail with respect to FIG. 22A. Carriage 88 is
likewise circular in shape and receives outer lip 112 of the first
retracting sleeve 110.
[0077] Actuator assembly 20 also includes a handle lock 40 which
rests atop the first retractor 80 and extends laterally between the
housing 26 and the cover plate 90. More particularly, handle lock
40 is mounted within slots 93a and 93b as best seen in FIG. 10.
Handle lock 40 includes a post 43 which receives a spring 45 for
biasing handle lock 40 against a ledge 49 of the housing 26 (FIG.
12). Handle lock 40 also includes a pair of flanges 42a and 42b
which align with flanges 14a and 14b disposed on handle 12. As
shown best in FIGS. 21 and 22, downward movement of the handle 12
forces the handle lock 40 initially distally against spring 45
until flanges 14a and 14b clear flanges 42a and 42b at which point
spring 45 forces handle lock 40 proximally to lock flanges 42a and
42b atop flanges 14a and 14b and to lock handle 12 in a downwardly
disposed position. Preferably, flanges 42a and 42b define a slot 41
for receiving lever 16 therebetween.
[0078] Actuator assembly 20 also includes a second retractor 50
which includes an elongated arm 52 having a key-like distal end 53
and a T-shaped heel section 56. Preferably, T-shaped heel section
56 attaches to a tension spring 55 disposed proximally thereof.
Second retractor 50 is preferably bifurcated at its proximal end
forming two longitudinally extending fins 58a and 58b each having a
slot 57 and aperture 59 for receiving cam followers 51 and 51b,
respectively. It is contemplated that spring 55 is biased against
an elongated stop 65 which rests atop arm 52 and biases heel
section 56 proximally when the second retractor 50 is retracted
which will be explained in more detail below with respect to the
operation of the surgical instrument 10.
[0079] As mentioned above, the first retractor 80 is affixed to
two-stage cam 60 by pin 54. More particularly, cam 60 includes an
aperture 61 located near the distal end thereof for receiving pin
54 which affixes the cam 60 to the first retractor 80. Cam 60 also
includes a pair of generally vertical arcuately-shaped slots 62 and
64 which each include two discrete stages, namely 62a, 62b and 64a,
64b, respectively, for imparting movement to corresponding
followers 51a and 51b. A nub 66 is located near the uppermost
portion of the cam 60 and is dimensioned to slideably engage recess
17 located in lever 16 as best illustrated in FIG. 12.
[0080] It is contemplated that during downward movement of handle
12, lever 16 will bias nub 66 downwardly such that nub 66 rides
proximally along recess 17 and causes cam 60 to pivot downwardly
about pin 54 as shown best in FIGS. 21A and 22. In turn, followers
51a and 51b will ride along slots 64 and 62 and cause the first and
second retractors 80 and 50 to move in a proximal direction which
will be explained in more detail below. Preferably, recess 17, nub
66 and slots 64 and 62 can be dimensioned to control the movement
and timing of the cam followers 51a and 51b. For example, it is
envisioned that the stages 64a, 64b and 62a and 62b can be
dimensioned to control the timing and movement of the first and
second retractors which, in turn, can effect the efficiency of the
anastomosis.
[0081] Elongated stop 65 is preferably affixed to the distal end of
cam 60 and rests atop the second retractor 50. Elongated stop 65
includes a distal end 69 and a proximal end 67 which includes two
extending portions 67a and 67b each having an aperture 63a and 63b,
respectively, disposed therethrough. Preferably, end 69 of stop 65
is sufficiently dimensioned such that it engages a corresponding
biasing post 102 located within the SULU 100.
[0082] Preferably, the second retractor 50, the cam 60 and the
elongated stop 65 are pre-assembled prior to insertion into the
first retractor 80. More particularly and as best illustrated in
FIGS. 10-12, elongated stop 65 is positioned atop arm 52 of the
second retractor 50 between T-shaped heel section 56 and end 53.
Apertures 63a and 63b of stop 65 align with aperture 61 of cam 60
such that once the cam 60 and the elongated stop 65 are inserted
within slot 91 of the first retractor 80, pin 54 locks the two
components 65 and 60 together through slot 85.
[0083] Cam 60 is positioned between the extending fins 58a and 58b
of the second retractor 50 such that, when the retractor 50 and cam
60 are inserted within slot 91 of the first retractor, followers
51a and 51b are inserted through slot 87 and slot 89, respectively,
and slideably couple the two components 50 and 60 within the first
retractor 80. Handle lock 40 is then positioned atop the first
retractor 80 as described above. First retractor 80 is then mounted
on ribs 25a and 25b of housing 26 and cover plate 90, respectively
and tab 30 along with sliding sleeve 32 are engaged thereon. Handle
12 and lever 16 are then assembled as described above and pivotably
mounted about post 21. Spring 70 is then positioned accordingly so
as to bias handle 12 against housing 26.
[0084] Turning now to FIGS. 7-9 which show an exploded view of the
internal working components of the SULU 100 which as mentioned
above includes first retracting sleeve 110 and second retracting
sleeve 120 which cooperate to deform fasteners 260 and securely
fasten the saphenous vein 320 to the LAD and/or aorta 310 in fluid
communication as shown in FIG. 24.
[0085] More particularly and as best seen in FIGS. 7-7D, first
retracting sleeve 110 includes a tube-like base 110a and an arcuate
sleeve cap 110b which together define the first retracting sleeve
110. Base 110a includes a circular lip 112 located at its proximal
end and a semi-circular anvil 118a located at the opposite end. A
locking tab 116a having an elongated slit 182a located therein is
disposed between lip 112 and anvil 118a. A longitudinally-extending
slot 114a is disposed between the lip 112 and the locking tab 116a.
At least one interface 117a downwardly depends from base 110a to
mechanically engage a corresponding mechanical interface 117b
disposed on sleeve cap 110b (FIG. 7). A flange 113a is preferably
disposed beneath slot 114a and is sufficiently dimensioned to
engage corresponding flanges 113b.sub.1 and 113b.sub.2 located on
sleeve cap 110b. Slot 114a is sufficiently dimensioned to receive a
tab 138a (FIG. 13) which projects from an upper surgical fastener
support 130a which is explained in more detail below.
[0086] Sleeve cap 110b includes a semi-circular anvil 118b and a
bifurcated proximal end 113 composed of flanges 113b.sub.1 and
113b.sub.2 which together define a slot 114b for receiving a tab
138b which projects from a lower surgical fastener support 130b
which is explained in more detail below. Sleeve cap 110b also
includes mechanical interfaces 117b which couples with
corresponding mechanical interfaces 117a disposed on base 110a to
engage sleeve cap 110b with base 110a. A locking tab 116b having an
elongated slit 182b located therein is disposed between proximal
end 113 and anvil 118b. A longitudinally-extending opening 111b is
preferably disposed proximate locking tab 116b and aligns with a
corresponding opening 111a in base 110a (FIG. 7C) such that the
saphenous vein 320 can be received therethrough as seen best in
FIGS. 17 and 18.
[0087] FIGS. 2A and 7D show a greatly enlarged view of anvil 118a
which includes a semi-annular array of fastener support channels or
cradles 119a each configured and dimensioned to support a surgical
fastener 260 therein. Sleeve cap 110b also includes fastener
support channels 119b which, when base 110a and sleeve cap 110b are
assembled, align to form a circular array about the internal
surfaces of anvil 118a and 118b. It is envisioned that anvils 118a
and 118b can be designed to support different arrays of surgical
fasteners 260 depending upon a particular purpose. Each channel
119a and 119b is preferably separated by an anchor 187a and 187b
(FIG. 7) which releasably retains a projecting finger 124a, 124b of
second retracting sleeve 120 (FIG. 2A). Support channels 119a and
119b each include proximal ends 186a and 186b and distal ends 184a
and 184b which are radially offset from one another to seat
surgical fastener 260 within channels 119a and 119b in a radially
offset manner the purpose of which will be explained below with
respect to the operation of the surgical instrument 10. The distal
end 184a of each channel 119a is preferably arched so as to
correspond to the arcuate shape of the end of the surgical fastener
260 as best seen in FIG. 13A. It is anticipated that arching the
distal end 184a will cause the surgical fastener 260 to deform
upwardly and proximally upon retraction of the first retracting
sleeve 110 by the first retractor 80 as explained below with
reference to FIGS. 21-22.
[0088] FIGS. 7-7D also show second retracting sleeve 120 which
includes an upper cuff 120a, a lower cuff 120b and an outer cap 128
which together define the second retracting sleeve 120. More
particularly, upper cuff 120a includes a semi-annular lip 122a at
one end and a plurality of retention fingers 124a at the opposite
end. Upper cuff 120a also includes a first slot 101 which
preferably aligns with slot 114a of the first retracting sleeve
110a to receive tab 138a of upper fastener support 130b
therethrough (FIG. 20). A second slot 126a receives locking tab
116a when cuff 120a is slideably mounted atop base 110a. Interfaces
129a mechanically engage corresponding interfaces 129b located on
lower cuff 120b.
[0089] Lower cuff 120b includes a bifurcated proximal end 107 which
comprises flanges 107b.sub.1 and 107b.sub.2 which define a slot 108
for receiving tab 138b of lower fastener support 130b therethrough
and a plurality of retention fingers 124b which extend from the
opposite end thereof. A slot 126b is disposed between the flanges
107b.sub.1, 107b.sub.2 and the fingers 124b for receiving locking
tab 116b of the sleeve cap 110b when cuff 120b is slideably mounted
thereon. A longitudinally-extending opening 121b is disposed
proximate slot 126b and aligns with a corresponding opening 121a in
upper cuff 120a and also aligns with openings 111a and 111b of the
first retracting sleeve 110 such that the saphenous vein 320 can be
received therethrough as seen best in FIGS. 17 and 18.
[0090] A semi-circular cuff cap 128 is disposed atop lower cuff
120b and mechanically interfaces with upper cuff 120a such that
semi-circular lips 122a and 122b for circular lip 122. More
particularly, cuff cap 128 includes a plurality of detents 123b
which mechanically engage a corresponding plurality of notches 123a
located in upper cuff 120a such that the cuff cap 128, upper cuff
120a and lower cuff 120b all move in unison upon retraction of the
second retracting sleeve 120. Sleeve cap 128 is preferably
bifurcated at its distal end forming slot 109 which is dimensioned
to receive tab 138b.
[0091] As can be appreciated, fingers 124a and 124b move upon
retraction of the second retracting sleeve 120 to release the
surgical fasteners 260 after firing. More particularly and as best
seen in FIGS. 2A and 7A, the distal end of each finger 124a is
forked and includes a first prong 127a which retains a surgical
fastener 260 within the fastener support channels 119a and a second
prong 125a which interlocks with anchor 187a to releasably lock the
finger 124a to the first retracting sleeve 110 until released by
the second retractor 50 (FIGS. 22A and 22B) which will be explained
in more detail with respect to the operation of the surgical
instrument 10. Likewise, each finger 124b of lower cuff 120b
includes prongs 127b and 125b which operates in the same
manner.
[0092] As mentioned previously, the SULU 100 also includes fastener
support 130 which has an upper support 130a and a lower support
130b which, when assembled, internally house the first and second
retracting sleeves 110 and 120, respectively, along with their
individual working components. Upper support 130a and lower support
130b each include a distal end 135a and 135b each having an array
of braces 137a and 137b, respectively, which project radially from
distal ends 135a and 135b. As best illustrated in FIG. 2, each
brace 137a and 137b supports an upwardly extending support leg 262
of a surgical fastener 260 disposed within one of the channels 119a
or 119b. A plurality of radially extending slots 139a and 139b are
disposed between each support brace 137a, 137b for retaining a
surgical fastener 260 therein and for restricting unwanted lateral
movement of each fastener 260. It is anticipated that each surgical
fastener 260 is positioned within a slot 139a, 139b such that
convexity 263 projects outwardly from brace 137a, 137b and, after
anastomosis, cooperates with the base leg 264 to retain the
saphenous vein 320 against LAD and/or aorta 310 (FIGS. 21B and
24).
[0093] Upper support and lower support 130a and 130b, respectively,
also include hinges 136a and 136b which, when the SULU 100 is
assembled, matingly engage one another to allow pivotable movement
between the supports 130a and 130b from an open position (FIG. 23)
to a closed position (FIG. 2). Preferably, a pin 180 secures the
two hinges 136a and 136b together (FIG. 6). Upper and lower
supports 130a and 130b each include a longitudinally-extending
opening 133a (FIG. 23) and 133b which aligns with openings 121a,
121b, 111a and 111b described above to receive saphenous vein 320
therethrough as seen best in FIGS. 17 and 18. Longitudinally
oriented slots 131a and 131b are disposed adjacent openings 133a
and 133b on the upper and lower support members 130a and 130b,
respectively, for receiving locking tabs 116a and 116b in much the
same manner as described above with respect to slots 126a and 126b
of the second retracting sleeve 120.
[0094] Lower support 130b includes a pair of shoulders 132a and
132b disposed on opposite sides of opening 133b for slideably
receiving a corresponding pair of flanges 144a and 144b associated
with an upper locking sleeve 140a. More particularly, each flange
144a and 144b extends distally from the upper locking sleeve 140a
to define a notch 149a and 149b, respectively, therein for
receiving shoulders 132a and 132b of lower support 130b.
[0095] Upper locking sleeve 140a includes a C-shaped clip 146a
(FIG. 8) disposed therein which has pair of opposing hooks 147a for
snap-lockingly engaging slit 182a of locking tab 116a of first
retracting sleeve 110. A lower locking sleeve 140b operates in a
similar manner and includes a pair of opposing hooks 147b for
snap-lockingly engaging slit 182b of locking tab 116b of first
retracting sleeve 110. Upper locking sleeve 140a also includes an
opening 141a which aligns with openings 133a, 133b, 121a, 121b,
111a and 111b described above to receive saphenous vein 320
therethrough as seen best in FIGS. 17 and 18. It is envisioned that
upon retraction of the second retracting sleeve 120, upper locking
sleeve 140a will move proximally relative to shoulders 132b and
134b and disengage shoulders 132a, 132b which, in turn, will allow
the upper and lower supports 130a and 130b to pivot about pin 180
and release the saphenous vein 320 (FIGS. 21E and 23). This will be
explained in greater detail with respect to the operation of the
instrument as described below.
[0096] SULU 100 also includes a biasing post 102 which mechanically
aligns upper and lower supports 130a and 130b in fixed relation
relative to one another. More particularly, biasing post 102
includes a proximal end 103 and a distal end 105 and has a
vertically oriented cavity 106 disposed therethrough for receiving
tabs 138a and 138b of the upper and lower supports 130a and 130b,
respectively. As mentioned above, tabs 138a and 138b pass through
slots 114a, 114b of the first retracting sleeve 110 and through
slots 101, 108 and 109 of the second retracting sleeve 120 and
mechanically align with one another within cavity 106 as best seen
in FIG. 21B.
[0097] Biasing post 102 also includes a tapered spacer 104 disposed
along the outer periphery thereof for frictionally locking the
first retracting sleeve 110 in a retracted position after the first
retracting sleeve 110 is withdrawn by the first retractor 80. More
particularly, when the SULU 100 is assembled and prior to firing
the surgical instrument 10, biasing post 102 is disposed relative
to the first retracting sleeve 110 such that spacer 104 is proximal
to lip 112 (FIG. 13). During retraction of the first retracting
sleeve 110, lip 112 is forced over spacer 104 and the first
retracting sleeve 110 is locked into retracted position and
prevented from recoiling. As explained in greater detail below,
locking the first retracting sleeve 110 in a retracted position
also pre-disposes the second retracting sleeve 120 for retraction
relative to the first retracting sleeve (FIG. 22A).
[0098] Turning now in detail to the loading of the SULU 100 within
actuator assembly 20 as best seen in FIG. 5, thumb tab 30 is moved
proximally by way of thumb guide 35 against spring 38 which, in
turn, moves sleeve 32 and protective cover 95 proximally to expose
carriages 86 and 88. The SULU 100 is then loaded within actuator
assembly 20 by placing lip 112 within carriage 88 and lip 122
within carriage 86. As best shown in FIG. 13, lip 122 is positioned
near the distal end of carriage 86 which allows lip 122 and, hence,
second retracting sleeve 120, to move independently from the first
retracting sleeve upon activation of the second retractor 50. In
contrast, carriage 88 is dimensioned smaller than carriage 86 such
that lip 112 fits snugly within carriage 88. Once the SULU is
positioned within carriages 86 and 88, thumb tab 30 is released and
spring 38 biases sleeve 32 and protective cover 95 distally over
lips 112 and 122 to lock the SULU 100 within the actuator assembly
20.
[0099] In use and as shown in FIGS. 17-24, surgical instrument 10
facilitates the performance of a vascular anastomosis and either
eliminates and/or minimizes the need for manual suturing of the
vessels. The method and usage described herein will be addressed in
terms of vascular anastomosis performed on a beating heart.
However, the presently disclosed surgical instrument 10 may also be
used in performing anastomoses of other tubular or luminal body
structures without departing from the scope of the present
disclosure. For example, surgical instrument 10 may be used in
conventional open CABG procedures using a median sternotomy or
other large incision without stopping the heart. Alternatively, the
thoracic "window" procedure may be used to achieve access to the
heart. The "window" approach involves a smaller incision and less
displacement of the ribs, and therefore is less traumatic to the
patient. For this approach, conventional surgical techniques are
used to determine the location of the incision to access the chest
cavity.
[0100] To gain access to the heart, after an incision is made, a
surgical retractor assembly may be used to separate the ribs at the
site of the incision as shown in FIG. 25. Specifically, a base 410
is placed on the chest of the patient with the central opening
defined by the base being positioned over the operative site.
Retractor assemblies 430 are mounted to the base 410 at various
locations. Each retractor assembly 430 includes a blade having a
hook to engage either a rib or the sternum therewith. The retractor
assemblies are mounted and used to retract ribs until a
sufficiently large opening in the chest cavity is defined to
provide direct access to the heart. For example, the sternum and
the fourth and fifth ribs can be split apart to create a window.
Other configurations of spreading the ribs and/or selectively
cutting individual ribs away from the sternum may also be utilized
for a particular procedure.
[0101] Once the desired access to the heart is achieved, the graft
vessel, e.g., the saphenous vein 320 is dissected from the
surrounding cartilage and muscle, and a free end of the vessel is
exposed. The occluded coronary artery, e.g., the LAD and/or aorta
310, is then prepared for receiving the saphenous vein 320 graft.
The heart is positioned in the desired orientation either by
traction sutures passing through the pericardium or by manipulation
with heart manipulation instruments which are held by the surgical
personnel or clamped in a fixed orientation to a base such as the
retractor assembly base. Blood flow through the LAD and/or aorta
310 can be restricted by cardiopulmonary bypass and pericardial
cooling. Alternatively, a dampening instrument may be applied
directly on the LAD and/or aorta 310 to restrict blood flow and
reduce movement of the heart near the LAD and/or aorta 310.
[0102] Turning now in detail to the operation of the surgical
instrument 10 and in particular, the operation of the SULU 100 as
detailed in FIGS. 17-24, once the saphenous vein 320 has been
harvested, the user inserts the free end 322 into opening 133 of
the SULU and pull via a surgical hook or graspers the free end 322
towards the distal end of the SULU 100. The user then everts the
saphenous vein 320 over the anvils 118a, 118b of the SULU 100 such
that the free end 322 of the saphenous vein 320 is retained by end
269 of the surgical fasteners 260. Everting of the saphenous vein
320 may be achieved by any suitable known instruments and/or
techniques such as by using graspers.
[0103] In some cases it may be preferable to orient the upper and
lower supports 130a and 130b in a slightly longitudinally offset
manner such that an angle is created relative to the transverse
plane of the two supports 130a and 130b in order to optimize the
anastomosis and to facilitate optimal blood flow across the graft
site from the saphenous vein 320 to the LAD and/or aorta 310. This
junction will create a more dramatically visible "heel" and "toe"
effect in which an acute or obtuse angle between the vessels is
clearly defined.
[0104] The remaining portion of the saphenous vein 320 is
preferably positioned away from the instrument 10 to facilitate
insertion of the saphenous vein 320 into the LAD and/or aorta 310
as shown in FIG. 18. The user then inserts the end of the SULU 100
into an incision 312 in the LAD and/or aorta such that the distal
end 269 of each of the plurality of fasteners 260 and the everted
end portions 322 of the saphenous vein 320 are sufficiently
inserted into and through incision 312 (FIGS. 19 and 20). As seen
best in the enlarged view of FIG. 20, the support leg 262,
convexity 263 and prong 267 of each surgical fastener 260 remains
outside incision 312. The instrument is now preset for firing.
[0105] FIGS. 21-22 show the firing sequence of instrument 10, i.e.,
when the handle 12 is depressed by the user. As best shown in FIGS.
21 and 21A, as handle 12 is depressed downwardly in the direction
of reference arrow "A", lever 16 simultaneously imparts movement to
both handle lock 40 and cam 60. More particularly, downward
movement of handle 12 causes flanges 14a and 14b of lever 16 to
urge flanges 42a and 42b of handle lock 40 distally against spring
45 in the direction of reference arrow "B" (FIG. 21). At the same
time, handle 12 causes recess 17 of lever 16 to bias nub 66 which,
in turn, causes cam 60 to deflect downwardly and proximally as best
seen in FIG. 21A. Preferably, recess 17 in lever 16 is dimensioned
to control the specific movement of nub 66 within recess 17 which,
in turn, controls the overall movement of cam 60. Downward and
proximal movement of cam 60 causes cam followers 51a and 51b to
move within the first cam stages 64a and 62a of slots 64 and 62,
respectively, which, in turn, moves the first retractor 80 and
protective cover 95 proximally in the direction of reference arrow
B.
[0106] As seen best in FIG. 21, as retractor 80 moves proximally as
a result of the movement of cam followers 51a and 51b within slots
64 and 62, slot 85 moves proximally until it abuts pin 54.
Preferably, when slot 85 abuts pin 54, cam 60 is forced more
downwardly about pin 54 such that cam followers 51a and 51b move
more proximally to engage the second stages 64b and 62b of the cam
slots 64 and 62, respectively.
[0107] As mentioned above, the first retractor 80 retracts the
first retracting sleeve 110 (FIG. 21) which, in turn, causes
surgical fasteners 260 to deform as shown in FIGS. 21B and 21D.
More particularly and as best shown in FIG. 21B, proximal movement
of the first retractor 80 causes both the first retracting sleeve
110 and the second retracting sleeve 120 to move proximally
relative to biasing post 102 until biasing post 102 abuts the end
69 of elongated stop 65. As a result, anvils 118a and 118b deform
the distal ends 269 of surgical fasteners 260 upwardly and
proximally towards braces 137a and 137b, respectively, i.e.,
arc-like distal ends 184a and 184b cause surgical fasteners 260 to
deform upwardly and proximally upon retraction of the first
retracting sleeve 110. At the same time, the LAD and/or aorta 310
is forced slightly proximally and extending prongs 267 penetrate to
hold the LAD and/or aorta 310 in position as best seen in FIG.
22A.
[0108] It is anticipated that the radially offset orientation of
the opposite ends 186a, 186b and 184a, 184b of the support channels
119a and 119b, respectively will cause the opposite ends 267 and
269 of the surgical fasteners 260 to deform at an angle
.A-inverted. relative to one another as best shown in FIG. 21D.
This allows end 269 to deform proximal to braces 137a and 137b.
Preferably, braces 137a and 137b have a tapered cross section to
deform end 269 of surgical fastener 260 radially from end 267
during deformation.
[0109] FIG. 21C shows the resulting position of the spacer 104 of
the biasing post 102 after the first retractor 80 retracts the
first and second retracting sleeves 110 and 120, respectively. More
particularly, spacer 104 frictionally locks the first retracting
sleeve 110 relative to the second retracting sleeve 120 and
prevents the first retracting sleeve 110 from recoiling after
firing.
[0110] FIG. 21E shows the proximal movement of the locking sleeve
140a as a result of the movement of the first retracting sleeve
110. More particularly, when the first retracting sleeve 110 is
retracted proximally, locking tab 116a retracts within slot 131a of
support 130a and biases locking sleeve 140a in a proximal direction
as well as seen by reference arrow "C". Proximal movement of the
locking sleeve 140a relative to support 130a disengages flanges
142a and 144a from shoulders 132b and 134b, respectively, of
support 130b which, in turn, unlocks supports 130a and 130b from
one another thus permitting pivotal movement of the support members
130a, 130b as best seen in FIGS. 21E and 23.
[0111] Continued downward movement of handle 12 results in both
proximal movement of the second retractor 50 and engagement of the
handle lock 40 with the handle 12. More particularly and as best
illustrated in FIG. 22, as the user continues to move the handle 12
in a downward direction, flanges 14a and 14b clear corresponding
flanges 42a and 42b and spring 45 biases handle lock 40 proximally
in the direction of reference arrow "D" to lock the handle 12 in
position. Simultaneously, cam 60 is rotated about pin 54 to a point
where the second stages 64a and 62a of the cam slots 64 and 62
effect the movement of the cam followers 51a and 51b. More
particularly, as cam 60 is forced downwardly, the second stage 62a
of cam slot 62 moves cam follower 51b proximally which, in turn,
moves the second retractor 50 proximally. The second stage 64a of
cam slot 64 is generally vertically oriented and, as a result, cam
follower 51a moves vertically upon continued downward movement of
handle 12. Slot 57 of retractor 50 allows the second retractor 50
to slide proximally relative to cam follower 51a.
[0112] As mentioned above, second retractor 50 moves the key-like
end 53 of the second retracting sleeve 120 within carriage 86
relative to the first retracting sleeve 110 as illustrated by
reference arrow "E" of FIG. 22A. Proximal movement of the second
retracting sleeve 120 retracts the prongs 127a and 127b of fingers
124a, 124b, respectively, which releases the surgical fasteners 260
as illustrated by reference arrow "E" of FIG. 22B.
[0113] As mentioned above, after sleeve 110 is retracted, locking
sleeve 140a moves proximally to allow the two supports 130a and
130b to pivot away from one another as shown in FIG. 23 to permit
the removal of the saphenous vein 320 from within the SULU thereby
completing the vascular anastomosis as shown in FIG. 24.
[0114] FIG. 26A shows a schematic diagram of the surgical fastener
staple pattern which is formed upon actuation of the instrument
described above with respect to FIGS. 1-26. More particularly, the
surgical fasteners are supported by the fastener support braces
137a, 137b in a normal manner relative to a longitudinal axis "A"
(FIG. 5) extending through the SULU. It is envisioned that other
surgical fastener staple patterns, e.g., spiral, tangential or
angular relative to axis "A", may be utilized to achieve hemostasis
between vessels, FIG. 26B.
[0115] It will be understood that various modifications may be made
to the embodiment shown herein. For example, the instrument may be
sized to perform an anastomosis for other vessels and luminal
tissue. Moreover, although the various internal components of the
instrument 10 are shown engaged by particular mechanical interfaces
it is envisioned that other types of mechanical interfaces can be
employed to achieve the same or similar purpose, e.g., snap-fit,
tongue and groove, press fit, etc. Therefore, the above description
should not be construed as limiting, but merely as exemplifications
of preferred embodiment. Those skilled in the art will envision
other modifications within the scope and spirit of the claims
appended hereto.
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