U.S. patent application number 09/756426 was filed with the patent office on 2001-05-10 for surgical anastomosis apparatus and method thereof.
This patent application is currently assigned to HEARTPORT, INC.. Invention is credited to Bolduc, Lee R., Heck, Christopher F..
Application Number | 20010000903 09/756426 |
Document ID | / |
Family ID | 27401379 |
Filed Date | 2001-05-10 |
United States Patent
Application |
20010000903 |
Kind Code |
A1 |
Heck, Christopher F. ; et
al. |
May 10, 2001 |
Surgical anastomosis apparatus and method thereof
Abstract
The present invention provides a method and end-to-side surgical
anastomosis apparatus for stapling an end of a tubular tissue
structure to a side of a luminal structure including an elongated
housing defining a central bore extending longitudinally
therethrough. The elongated housing further includes an eversion
support surface extending circumferentially about the bore opening
adjacent the distal end which is configured to retain and support
an everted end of the received tissue structure thereon to face an
intimal surface of the tissue structure in an outward direction.
The anastomosis apparatus further includes an anvil having a
fastener engaging surface, and a compression device having a
shoulder portion formed for selectively compressing the everted end
of the tissue structure and a surface of the luminal structure
together against the fastener engaging surface. The compression
device is further formed to deform the fasteners into contact with
the everted end of the tubular tissue structure and the luminal
structure to create an anastomotic bond between the tubular tissue
structure and the luminal structure. At least one driver pin is
preferably provided moveable relative to the compression device for
ejecting the plurality of fasteners through the everted end of the
tubular tissue structure and the luminal structure to engage the
fastener engaging surface. This engagement deforms the fastener and
creates an anastomotic bond between the tubular tissue structure
and the luminal structure.
Inventors: |
Heck, Christopher F.;
(Plymouth, MN) ; Bolduc, Lee R.; (Mountain View,
CA) |
Correspondence
Address: |
JENS E. HOEKENDIJK
P.O. Box 4787
Burlingame
CA
94011-4787
US
|
Assignee: |
HEARTPORT, INC.
|
Family ID: |
27401379 |
Appl. No.: |
09/756426 |
Filed: |
January 8, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09756426 |
Jan 8, 2001 |
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09488140 |
Jan 20, 2000 |
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6176413 |
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09488140 |
Jan 20, 2000 |
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09267247 |
Mar 12, 1999 |
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09267247 |
Mar 12, 1999 |
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08979831 |
Nov 20, 1997 |
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5881943 |
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08979831 |
Nov 20, 1997 |
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08759110 |
Dec 2, 1996 |
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08759110 |
Dec 2, 1996 |
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08550285 |
Oct 31, 1995 |
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5709335 |
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08550285 |
Oct 31, 1995 |
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08261167 |
Jun 17, 1994 |
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Current U.S.
Class: |
227/176.1 ;
227/175.1 |
Current CPC
Class: |
A61B 2017/081 20130101;
A61B 2017/1121 20130101; A61F 2/064 20130101; A61B 2017/00243
20130101; A61B 2017/1135 20130101; A61B 2017/1103 20130101; A61B
17/1114 20130101; A61B 17/1152 20130101 |
Class at
Publication: |
227/176.1 ;
227/175.1 |
International
Class: |
A61B 017/04 |
Claims
What is claimed is:
1. A method of end-to-side surgical anastomosis between a tubular
tissue structure, having at least one end, and a luminal structure,
such as a vascular lumen or another tubular tissue structure,
comprising the steps of: everting an end of the tubular tissue
structure to face an intimal surface thereof in an outward
direction; contacting the intimal surface of the everted end with a
surface of the luminal structure adjacent a surgically formed
opening therein; and applying a plurality of fasteners to said
tubular tissue structure and said luminal structure to form an
anastomotic bond between the intimal surface of the tubular tissue
structure and the surface of the luminal structure.
2. The surgical anastomosis method of claim 1 wherein, the surface
of the luminal structure is an intimal surface thereof.
3. The surgical anastomosis method of claim 1 wherein, the surface
of the luminal structure is an adventitial surface thereof.
4. The surgical anastomosis method of claim 1 wherein, said
applying step is performed by simultaneously applying the plurality
of fasteners to the tubular tissue structure and the luminal
structure.
5. The surgical anastomosis method of claim 4 wherein, said
fasteners are provided by staples, and said applying, step is
performed by simultaneously piercing the plurality of staples
through the tubular tissue structure and the luminal structure.
6. The surgical anastomosis method of claim 1 wherein, said
plurality of fasteners are applied to the tubular tissue structure
and the luminal stricture in a non-circular arrangement.
7. The surgical anastomosis method of claim 4 wherein, said everted
end is maintained in a non-circular shape during said step of
applying.
8. The surgical anastomosis method of claim 7 wherein, the
non-circular shape is generally tear-drop shaped.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
1. This application is a divisional of co-pending patent
application Ser. No. 08/979,831 filed Nov. 20, 1977, which is a
continuation of application Ser. No. 08/759,110 filed Dec. 2, 1996,
now abandoned, which is a continuation-in-part of application Ser.
No. 08/550,285, filed Oct. 31, 1995, now issued as U.S. Pat. No.
5709,335, which is a continuation of application Ser. No.
08/261,167, filed Jun. 17, 1994, now abandoned,
continuation-in-part of Ser. No. 08/550,285 which is a continuation
of Ser. No. 08/261,167, now abandoned. The complete disclosures of
these applications are hereby incorporated herein by reference.
FIELD OF THE INVENTION
2. The invention relates generally to surgical stapling appliances
and more particularly to an improved apparatus and method for the
anastomotic surgical stapling of luminal organs, such as vascular
lumens.
BACKGROUND OF THE INVENTION
3. Various instruments are known in the prior art for end-to-end
and end-to-side anastomotic surgical stapling together of parts of
the alimentary canal (i.e., esophagus, stomach, colon, etc.). These
instruments employ staple cartridges, generally in the shape of a
hollow cylinder, of different sizes to accommodate tubular organs
of varying diameters. End-to-end and end-to-side anastomoses are
achieved by means of at least one ring of surgical staples.
4. The traditional technique for surgical stapling anastomosis is
to position the stapling cartridge within the tubular organ to be
stapled. The cut end of the tubular organ is inverted (i.e., folded
inwardly) over the annular end of the staple cartridge creating an
inverting anastomosis upon stapling. An essential requirement of
the inverting anastomotic technique is the incorporation of knives
within the staple cartridge to trim excess tissue from the
anastomotic connection.
5. The prior art anastomotic stapling instruments form generally
circular anastomotic connections, and have been largely limited to
alimentary organs. With respect to end-to-side vascular
anastomosis, circular connections, rather than an elliptical
connections, are sometimes disadvantageous as they are less
physiologic or natural. This unnatural connection may create
turbulence in the blood flow as it courses through the anastomosis,
damaging the intima (i.e., inner wall) of the blood vessel and
predisposing it to forming blood clots.
6. In the present state of the art, end-to-end and end-to-side
anastomosis between blood vessels have typically been accomplished
by hand-sewn suturing techniques. These techniques are time
consuming, not as reliable as stapling, and subject to greater
human error than stapling. Current stapling instruments used for
alimentary canal are not suitable, however, for vascular
anastomosis due to their large sizes and inability to provide
non-circular and low turbulence anastomoses. A typical prior art
instrument has a circumference of approximately 8 cm (3 in), far
too thick to accommodate coronary arteries and veins, which have
circumferences ranging from 0.50 to 1.0 cm and from 1.5 to 2.5 cm,
respectively.
7. An additional drawback of prior stapling instruments is the
inability to provide an everted (i.e., folded outwardly)
anastomosis. An inverted vascular anastomosis would expose the cut
ends of the blood vessels to the vessel lumen and could lead to the
formation of blood clots. For this reason, hand-sewn everted
anastomoses for vascular connections are preferable, despite time
and reliability drawbacks.
8. Accordingly, it is a general object of the present invention to
provide an improved instrument and method for vascular
anastomosis.
9. It is also an object of the present invention to provide a
surgical anastomosis apparatus small enough to accommodate vascular
lumens.
10. Another object of the present invention is to provide a
surgical anastomosis apparatus for everted anastomosis.
11. Another object of the present invention is to provide a method
for surgical stapling that does not require the removal of excess
tissue from the anastomotical connection.
12. Still another object of the present invention is to provide an
instrument and method for vascular anastomosis that is less
time-consuming and more reliable than the prior art.
SUMMARY OF THE INVENTION
13. The present invention provides a novel instrument and method
for vascular anastomoses which overcomes the drawbacks of prior art
designs and achieves the aforesaid advantages.
14. Very generally, the surgical stapling instrument of the present
invention is for stapling a tubular tissue structure having at
least one distal end to a luminal structure, such as a vascular
lumen or another tubular tissue structure. The instrument comprises
a rod having a circumference sufficient to pass within the tubular
tissue structure, an anvil mounted on the rod, and a generally
tubular staple cartridge for containing a plurality of staples. The
anvil has an array of staple deforming means thereon and is of a
size sufficient to pass through a surgically formed opening in and
to be accommodated within the luminal structure. The inner passage
of the staple cartridge is sufficient to axially accommodate the
tubular tissue structure between the rod and the inner surface of
the staple cartridge, and sufficient to allow the staple cartridge
to be moved axially along the rod. The staple delivery end of the
staple cartridge is positioned toward the staple deforming means of
the anvil and has an outer dimension small enough so that the
tubular tissue structure can be everted thereover. A clamping
mechanism secures the everted portion of the tubular tissue
structure and the luminai structure adjacent to the surgically
formed opening between the staple cartridge and the anvil. A
plurality of staples may then be ejected to pass through the
everted portion of the tubular tissue structure and the luminal
structure to engage the staple deforming means to deform the
staples and create a bond between the tubular tissue structure and
the luminal structure.
15. In another aspect of the present invention, an end-to-side
surgical anastomosis apparatus is provided for stapling an end of a
tubular tissue structure to a side of a luminal structure. The
anastomosis apparatus includes an elongated housing defining a
central bore extending longitudinally therethrough and terminating
at a bore opening at a distal end of the housing. The central bore
includes a transverse cross-sectional dimension sufficiently sized
and configured for receipt of the tissue structure therein in a
manner positioning the end of the tissue structure through the bore
opening. The elongated housing further includes an eversion support
surface extending circumferentially about the bore opening adjacent
the distal end. This surface is configured to retain and support an
everted end of the received tissue structure which extends through
the bore opening to face an intimal surface of the tissue structure
in an outward direction. The anastomosis apparatus further includes
an anvil having a fastener engaging surface, and a compression
device having a shoulder portion formed for selectively compressing
the everted end of the tissue structure and a surface of the
luminal structure together against the fastener engaging surface.
The compression device is further formed to deform the fasteners
into contact with the everted end of the tubular tissue structure
and the luminal structure to create an anastomotic bond between the
tubular tissue structure and the luminal structure.
16. At least one driver pin is preferably provided moveable
relative to the compression device for ejecting the plurality of
fasteners through the everted end of the tubular tissue structure
and the luminal structure to engage the fastener engaging surface.
This engagement deforms the fastener and creates a bond between the
tubular tissue structure and the luminal structure.
17. In still another aspect of the present invention, a method of
end-to-side surgical anastomosis is provided between a tubular
tissue structure, having at least one end, and a luminal structure,
such as a vascular lumen or another tubular tissue structure. The
method includes the steps of A) inserting the tubular tissue
structure in a central bore of an anastomosis apparatus, and B)
everting an end of the tubular tissue structure over and against an
eversion support surface of the anastomosis device and at a distal
end of the central bore to an everted condition positioning an
intimal surface of the everted end in a direction facing outwardly.
The next steps of the present invention include C) positioning the
everted end of the tubular tissue structure and a surface of the
luminal structure between an anvil and an opposed shoulder of a
compression device of the anastomosis apparatus, and D) contacting
the intimal surface of the everted end with a surface of the
luminal structure adjacent a surgically formed opening therein.
Finally, the last step of the method of end-to-side surgical
anastomosis of the present invention includes E) applying a
plurality of fasteners to the everted end of the tubular tissue
structure and the surface of the luminal structure to contact the
anvil and deform the fasteners to form an anastomotic bond
therebetween.
DETAILED DESCRIPTION OF THE DRAWINGS
18. The procedure and system of the present invention have other
objects and features of advantage which will be readily apparent
form the following description of the Best Mode of Carrying Out the
Invention and the appended claims, when taken in conjunction with
the accompanying drawings, in which:
19. FIG. 1 is a fragmentary side elevation view, in cross section,
of one embodiment of the anastomosis device constructed in
accordance with the present invention and illustrating an end of
the tubular tissue structure everted over the device end.
20. FIG. 2 is a front elevation view, in cross-section, of the
anastomosis device taken substantially along the plane of the line
3--3 in FIG. 1
21. FIG. 3 is a rear elevation view, in cross-section, of the
anastomosis device taken substantially along the plane of the line
2--2 in FIG. 1
22. FIG. 4 is a side elevation view, in cross-section, of the anvil
of the anastomosis device taken substantially along the plane of
the line 4--4 in FIG. 3
23. FIG. 5 is a front elevation view, in cross-section, of an
alternative embodiment of FIG. 3 illustrating a tear drop-shaped
configuration.
24. FIG. 6 is a rear elevation view, in cross-section, of the anvil
of the alternative embodiment of FIG. 5 taken substantially along
the plane of the line 2--2 in FIG. 1
25. FIG. 7 is an exploded top perspective view, partially cut-away,
of the anastomosis device of FIG. 1.
26. FIG. 8 is an enlarged, exploded, top perspective view,
partially cut-away, of a staple cartridge assembly of the
anastomosis device of FIG. 1.
27. FIG. 9 is an enlarged, side elevation view, in cross-section,
of the anvil and staple cartridge assembly of the anastomosis
device of FIG. 1 illustrating the deformation of a staple.
28. FIGS. 10-12 is a sequence of top perspective views illustrating
the loading of a tubular tissue structure in the anastomosis device
of FIG. 1
29. FIG. 13 is an enlarged, side elevation view, in partial
cross-section, showing the positioning of the anvil of the
anastomosis device through a luminal structure.
30. FIG. 14 is a reduced top perspective view of the anastomosis
device of FIG. 1 mounted to the luminal structure.
31. FIG. 15 is a reduced top perspective view of the tubular tissue
structure anastomotized to the luminal structure using the
anastomosis device of FIG. 1.
32. FIG. 16 is a front elevation view of a grafted tubular tissue
structure anastomotized to a coronary artery of the heart through
the anastomosis device of FIG. 1.
33. FIG. 17 is an exploded top perspective view of an alternative
embodiment of the anastomosis device of the present invention.
34. FIG. 18 is a fragmentary, enlarged top perspective view of a
staple cartridge assembly of the alternative embodiment anastomosis
device of FIG. 17.
35. FIG. 19 is an end view of the staple cartridge assembly of FIG.
18.
36. FIGS. 20-22, 24, 25, 27 and 28 is sequence of top perspective
views illustrating the application of the alternative embodiment
anastomosis device of FIG. 17 for proximal anastomosis of the
grafted tubular tissue structure to the ascending aorta.
37. FIGS. 23 and 26 is a sequence of fragmentary, top perspective
views illustrating the loading of a tubular tissue structure in the
alternative embodiment anastomosis device of FIG. 17
38. FIG. 29 is a fragmentary, top perspective view of an
alternative embodiment anastomosis device constructed in accordance
with the present invention.
39. FIG. 30 is an enlarged, fragmentary side elevation view, in
cross-section, of the anastomosis device of FIG. 29 illustrating a
distal end of the tubular tissue structure everted over a distal
end of the eversion mandrel.
40. FIG. 31 is a top plan view of the anastomosis device of FIG. 29
taken substantially along the plane of the line 31--31 in FIG.
30.
41. FIG. 32 is a fragmentary side elevation view, in cross-section,
of an alternative embodiment bell-shaped distal end of the eversion
mandrel of FIG. 31 having the tubular tissue structure everted over
a distal end of the bell-shaped eversion mandrel.
42. FIG. 33 is a fragmentary, top perspective view of the eversion
mandrel of anastomosis device of FIG. 29 in an opened
condition.
43. FIG. 34 is a fragmentary, enlarged top plan view of a hinge
assembly of the anastomosis device of FIG. 29.
44. FIG. 35 is a fragmentary, top perspective view of the
anastomosis device of FIG. 29 and illustrating the tubular tissue
structure everted over the distal end of the eversion mandrel.
45. FIG. 36 is an enlarged, fragmentary side elevation view, in
cross-section, of the anastomosis device of FIG. 29 illustrating a
compression device in a compressed condition.
46. FIG. 37 is an enlarged, fragmentary, top perspective view,
partially cut-away, of the eversion mandrel of the anastomosis
device of FIG. 29 positioned in a surgically formed opening in a
luminal structure.
47. FIG. 38 is an enlarged, fragmentary side elevation view, in
cross-section, of the tubular tissue structure grafted to the
luminal structure employing the anastomosis device of FIG. 29.
48. FIG. 39 is an enlarged, fragmentary top perspective view of a
tubular tissue structure grafted to the luminal structure employing
the anastomosis device of FIG. 29.
DETAILED DESCRIPTION OF THE INVENTION
49. Reference will now be made in detail to the preferred
embodiments of the invention. The present invention provides
methods and devices for performing surgical interventions within
the heart or a great vessel such as the aorta, superior vena cava,
inferior vena cava, pulmonary artery, pulmonary vein, coronary
arteries, and coronary veins, among other vessels. While the
specific embodiments of the invention described herein will refer
to a closed-chest surgical procedure and system for the treatment
of medically refractory a trial fibrillation, it should be
understood that the invention will be useful in performing a great
variety of surgical procedures requiring the ablation of tissue
structure, including surgical treatment of Wolfe-Parkinson-White
(WPW) Syndrome, ventricular fibrillation, congestive heart failure
and other procedures in which interventional devices are introduced
into the interior of the heart, coronary arteries, or great
vessels. Advantageously, the present invention facilitates the
performance of such procedures through percutaneous penetrations
within intercostal spaces of the rib cage, eliminating the need for
a median sternotomy or other form of gross thoracotomy. However, as
will be apparent although not preferred, the system and procedure
of the present invention could be performed in an open-chest
surgical procedure as well.
50. Referring to FIGS. 1-7, there is shown a structural embodiment
of the present invention which is best suited for anastomotic
stapling of a tubular vessel having two distal or untethered ends.
As will be evidenced by the detailed description below, this
embodiment, i.e., distal stapler, is ideal for use during
cardiopulmonary bypass surgery for making the primary anastomotic
connection of a bypass vein to a coronary artery or to the
aorta.
51. Referring now to FIG. 1, a portion 10 of the wholly configured
distal stapler of the present invention, as shown in FIG. 7,
comprises an elongated central rod 12 with anvil 14 mounted at its
distal end 16. Anvil 14 is in the form of a circular, elliptical or
tear drop-shaped disk and is mounted, by suitable means such as
welding, to the end of central rod 12 transversely thereof and at
the center of the anvil. The edges of anvil 14 are beveled or
otherwise generally rounded to enable anvil 14 to slip easily
through incisions in vascular walls--much like a button through a
button hole.
52. The central rod 12 has a circumference sufficient to permit the
rod to axially extend through a tubular vessel, indicated in
phantom at 20, to be stapled. Central rod 12 also axially extends
within tubular housing 22, driver pins 24 and staple cartridge 26,
together forming a contiguous shaft 28 having an inner
circumference sufficient to accommodate tubular vessel 20
sandwiched between them and central rod 12. Staple cartridge 26 has
an outer circumference sufficient to accommodate everted end 34 of
tubular vessel 20. Lip 36 of cartridge 26 is tapered to facilitate
eversion of tubular vessel 20. Anvil 14 has circumference of a size
equivalent to the outer circumference of staple cartridge 16.
53. Circumferences of vascular vessels range from 0.50 to 1.0 cm
for coronary arteries and from 1.5 to 2.5 cm for veins.
Accordingly, all circumferences, discussed above, of stapler 10 are
of a size to optimally coaxially accommodate the vein to be
stapled.
54. The end of central rod 12 opposite anvil 14 is centrally
mounted, preferably welded, on a cylindrical base 40 which extends
coaxially within tubular housing 22 (as shown in FIG. 7 by
reference number 106) and has a circumference sufficient to be
slidable within tubular housing 22. The accommodated tubular vessel
20 extends along central rod 12 to cylindrical base 40. Provided on
the surface of central rod 12 proximal to base 40 is
circumferential groove 44 for facilitating the securing of tubular
vessel 20 to rod 12 by means of string 46. Similarly,
circumferential groove 48 and string 50 are provided to secure
everted end 34 of vessel 20 to staple cartridge 26. An alternative
embodiment of staple cartridge 26 for securing an everted vein
comprises tiny hooks around the circumference at end 36 of the
cartridge. Other suitable means for accomplishing the securing
function may be used as well.
55. Referring now to FIG. 2, there is shown a cross-sectional view
of stapler 10 of the present invention in the direction of arrows
2--2 of FIG. 1. Here, the staple delivery end 60 of a circular
staple cartridge is illustrated encasing a circular array of staple
delivery means or staple shafts 62. The present invention is not
limited to a single staple shaft array however. It is commonly
known in the art to employ a plurality of concentric arrays or rows
of staple shafts for anastomotic procedures. Extending from staple
shaft array 62, is an array of narrow channels 68, each narrow
channel corresponding to each staple shaft. Channel array 68 is
used solely for manufacturing purposes and is not a necessary
element of the invention. Central rod 64 and its base 66 are
axially and centrally located within the cylindrical staple
cartridge 60.
56. FIG. 3 shows the underside view of anvil 70 in the direction of
arrows 3--3 of FIG. 1. The anvil 70 has an array 74 of means for
deforming staples. Central rod attachment 72 is centrally located
on anvil 70 which provides an array of staple deforming means 74,
comprised here of an array of recess pairs, for bending staples
projected from corresponding array of staple shafts 62 of the
staple cartridge of FIG. 2.
57. Depicted in FIG. 4 is a cross-sectional view of anvil 70 in the
direction of arrows 4--4 of FIG. 3. Each recess pair 76 is curved
to bend staple legs radially inward. The projected staples can be
made to bend radially inward or radially outward depending on the
spacing 78 between the recess of each paired recess 76.
Alternatively, each recess can be positioned orthogonal to its
present position to bend the staple legs at right angles to their
axis of projection.
58. Although the present invention is primarily described and
depicted as forming staple bonds that are circular and as having
component circumferences that are circular, other embodiments are
realized for forming staple bonds having elliptical, tear drop or
other generally oval circumferences. Accordingly, the anvil and
associated staple recess array, and the cartridge housing and
associated staple shaft array of these alternative stapler
embodiments have circumferences in the shape of the desired staple
bond. For example, FIGS, 5 and 6 illustrate an anvil and staple
cartridge, respectively, having tear-drop shaped
circumferences.
59. FIG. 5 shows a cross-sectional view of a tear-drop shaped
staple cartridge. The staple delivery end 80 of the staple
cartridge is illustrated encasing a tear drop array of staple
delivery means or staple shafts 82. Extending from staple shaft
array 82, is an array of narrow channels 84, each narrow channel
corresponding to each staple shaft. Channel array 84 is used solely
for manufacturing purposes and is not a necessary element of the
invention. Central rod 86 and its base 88 are coaxially and
centrally located within the cylindrical portion of dear drop
staple cartridge 80.
60. FIG. 6 shows the underside view of a tear drop shaped anvil 90.
Central rod attachment 92 is centrally located on the circular
portion of anvil 90 which provides an array of staple deforming
means comprised of recess pairs 94 for bending staples projected
from corresponding array of staple shafts 82 of the staple
cartridge of FIG. 5.
61. Referring now to FIG. 7, there is shown stapler 100 of the same
embodiment depicted in FIGS. 1-4. A tubular housing 102 coaxially
contains central rod 104 and rod base 106, the end of central rod
104 opposite that of anvil 114 being suitably mounted, such as by
welding, to rod base 106 (connection not shown). Threadedly mounted
to and extending perpendicular from rod base 106 is a short stem
108, positioned at approximately half the length of base 106. The
top of stem 108 has cylindrical knob 110 transversely mounted. Stem
108 is moveable within narrow channel 112, cut within housing 102
and running parallel to the axis traveled by central rod 104 and
rod base 106. Channel 112 limits the rotational movement of stem
108 and thereby maintains a proper radial orientation between anvil
114 and staple cartridge 116 during reciprocation.
62. Weldedly mounted to and protruding perpendicularly from
cylindrical face 118 of housing 102 and paralleling rod 104 is
cylindrical array of staple driver pins 120, all drivers pins being
identical and each having the form of a solid parallelogram. Staple
cartridge 116 encases, from end to end, cylindrical array of hollow
staple shafts 122 which holds a plurality of preloaded staples (not
pictured). All shafts 122 are identical and each has height and
width dimensions such that a corresponding staple driver pin 120 is
slidable therein.
63. In order to have an optimally functioning stapler, it is
necessary to maintain a clean and clear passageway for central rod
104, base 106 and staple shafts 122. Accordingly, one embodiment of
the present invention comprises a disposable cartridge which is
disposed of and replaced after one anastomotic stapling. Another
embodiment provides a slidable sleeve around the driver pin array
to prevent blood and tissue from getting caught therein.
64. For anastomosis to be successful, it is imperative not to
injure the living tissue being stapled by overcompressing it
between anvil 114 and staple cartridge 116 or by a staple bond that
is exceedingly tight. Accordingly, overcompression of the tissue is
prevented in the present invention by limiting the length of driver
pins 120. Other embodiments are known in the prior art for
accomplishing this objective. For example, U.S. Pat. No. 4,573,468
employs mutually coacting stops located on the inner surface of a
tubular housing and on the surface of a coaxial rod to provide
variable degrees of engagement between tissues to be stapled so as
to ensure against overcompression of the tissue. A spring-loaded
engagement between the rod and tubular housing is also applicable
for the present invention. Other means suitable for this purpose
will be apparent to those having ordinary skill in the art.
65. Finally, FIG. 7 illustrates threaded end 124 of rod base 106
which extends beyond the length of housing 102 to threadedly engage
with cylindrical nut 126 which has internally threaded throughbore
128 extending the full length of cylindrical nut 126 to allow end
124 to exit therethrough.
66. FIGS. 8 and 9 illustrate the mechanical interaction between the
staple driver, staple cartridge and anvil upon engagement. FIG. 8
illustrates staple driver array 200 mounted on face 202 of tubular
housing 204 slidably engaged within staple shaft array 206 of
staple cartridge 208. Staple array 210 is projected from staple
cartridge 208 and through the tissues to be stapled (not shown).
FIG. 9 shows a close-up of a staple being driven by driver pin 252
and projecting through cartridge 254 through tissues 256 and 258.
The legs 260 and 262 of staple 250 then engage with and bend along
the curved recesses 264 and 266, respectively, of anvil 268 to form
a bond between tissues 256 and 258.
67. Referring now to FIGS. 10-16, with like numbers referring to
like elements, there is illustrated the steps of the anastomotic
procedure using the structural embodiment described above. Now
referring to FIG. 10 specifically, the anvil-headed end of rod base
302 is inserted into transected vein 304 having a length in the
range of 10-18 cm (4-7 inches). End 308 (the end to be stapled) of
vein 304 is positioned proximate to anvil 306. Opposing end 310 of
vein 304 is tied with string 312 to central rod 314 at a
circumferential depression (not shown) proximate to base 302.
68. FIG. 11 shows the step of inserting central rod 314 with
attached vein 304 into staple cartridge 318 and tubular housing 316
such that staple cartridge 318 is proximate to anvil 306. FIG. 12
illustrates the next several steps of the method of the present
invention which can be performed in any order. The end of vein 304
is everted over staple cartridge 318 and tied with string 320
securing it to staple cartridge 318 (covered by vein 304). Threaded
stem 322 of cylindrical knob 324 is threadedly engaged with a
threaded bore (not shown) base 302, the bore being aligned with
narrow channel 326. Cylindrical nut 328 is threadedly engaged with
the threaded end 300. As indicated in FIG. 13, anvil 306 is
positioned within lumen 330 of vascular artery 332 via incision
334. A cross-section of a portion of vein 304 is shown everted over
the staple delivery end of staple cartridge 318.
69. In FIG. 14, central rod 314 (not visible) and rod base 302 (not
visible) are optimally coaxially positioned within tubular housing
316 by means of sliding knob 324 along channel 326 toward vascular
artery 332. Nut 328 is rotated in a clockwise direction to engage
it with tubular housing 316 causing rod base 302 to become rigidly
interconnected with nut 328. As the clockwise turning continues,
rod base 302 is drawn through the bore in nut 328, bringing the
staple cartridge 336 and anvil 306 within artery 332 together. An
embodiment employing mutually coacting stops (not shown) would, at
this point, be at the first coacting position or the "loaded"
position. The clockwise motion is continued so that everted vein
304 engages with the wall of artery 332 and until the staple
drivers (not visible) are actuated, driving the staples (not
visible) through the tissues to create a bond 338 (FIG. 15). If
mutually coacting stops are employed, the configuration would be in
the "firing" position.
70. Finally, FIG. 16 illustrates heart 350 having aorta 352,
pulmonary artery 354, right atrium 356, right ventricle 358, left
ventricle 360, left a trial appendage 362, right coronary artery
364, left anterior descending artery 368, and diagonal artery 370.
Here, vein 304 has been anastomotically stapled to left anterior
descending artery 368.
71. To complete the anastomotic procedure of the bypass vein 304,
the unstapled end of the anastomotized vein 304 must now be
connected to aorta 352. However, another structural embodiment of
the present invention, referred to as the "proximal" stapler, is
needed since the embodiment described above, i.e., the "distal"
stapler, requires the vein to have two distal or untethered ends.
Accordingly, FIGS. 17-28 describe a structure and method thereof
for a second embodiment of the present invention which is suited
for the anastomotic stapling of a tubular vessel having only one
distal end, the other end having already been anastomotically
stapled.
72. Referring now to FIGS. 17-19, with like numbers referencing
like elements, there is shown anastomotic stapler 400 having handle
402 with elongated vessel rod 404 and elongated driver rod 406
mounted perpendicularly to handle face 408 and parallel to each
other, both being of approximately the same length. Vessel rod 404
has a centrally mounted generally circular anvil 410. Vessel rod
404 has a circumference sufficient to coaxially accommodate a
tubular vessel (not shown) to be stapled to the aorta. Driver rod
406, having threaded end 412 and handle 414, extends through bore
416 of handle 402.
73. Stapler 400 also comprises staple cartridge 418, enlarged in
FIG. 18 for purposes of describing its detail. Referring then to
FIG. 18, there is shown the staple cartridge of FIG. 17 in its open
position having top and bottom units 420 and 422, respectively.
Units 420 and 422 are engaged at one side by hinge 424 which allows
cartridge 418 to be opened and closed. Staple cartridge 418 has two
parallel bores 426 and 428 with inner circumferences sufficient to
coaxially accommodate vessel rod 404 with a coaxially accommodated
vein (not shown) and driver rod 406, respectively. Staple delivery
end 430 extends from staple cartridge 418 along the axis of bore
426 to accommodate the everted end of a vein to be stapled. Bore
428 is internally threaded to be threadedly engagable with driver
rod end 412.
74. For a proper fit between units 420 and 422, a detent-recess
pair is provided havinly detent 432 extending from inner surface
434 of top unit 420 which mates with recess 436 within inner
surface 438 of bottom unit 422. To secure closing, a curved clip
440 is provided to fit around cylindrical casing 442 of bore
428.
75. When in a closed position, staple cartridge 418 has cylindrical
staple delivery means or staple shaft array (not shown) encased in
staple delivery end 430 which mates with cylindrical driver pin
array 444 mounted on driver 446. Both the hollow shafts and the
solid driver pins have height and width measurements that allow
them to be slidably engagable with each other. Driver 446 is
slidable along surface 448 of top unit 420 and surface 450 of
bottom unit 422 to the point of engagement with shoulder 452 of top
unit 420 upon which driver pin array 444 becomes engaged within the
staple shaft array, projecting preloaded staples from the end of
staple delivery end 430. Shoulder 452 limits the engagement of
driver pin array 444 so that the tissue being stapled is not
overcompressed. Modifications of the this embodiment can employ
mutually coacting stops or spring-loaded type configurations
between the driver and staple cartridge to prevent against
overcompression of the tissue.
76. FIG. 19 shows a front view of staple cartridge 418 in its
closed position with top unit 420 engaged with bottom unit 422.
Clip 440 securely fits around cylindrical casing 442. Staple
deforming end or staple shaft array 454 is shown on the face of
staple delivery end 430.
77. FIGS. 20-28, with like numbers referencing like elements,
depict the various steps of the anastomotic procedure using the
structural embodiment in FIGS. 17-19 described above. Referring now
to FIG. 20, vessel rod 500 is inserted through aorta 502 of heart
504 via incisions 506 and 508 on opposing walls of aorta 502 such
that anvil 510 is centrally positioned within aorta 502.
78. In FIG. 21, the end of vessel rod 500 is then inserted into the
distal end of vein 512 with anvil 510 still centrally positioned
within aorta 502. Next, as shown in FIG. 22, vessel rod 500 with
accommodated vein 512 is positioned within the corresponding bore
514 in open staple cartridge 516. Rod 500 and vein 512 should be
positioned such that a sufficient length of distal end 518 of vein
512 extends beyond the end of cartridge 516 such that distal end
518 can be everted over cylindrical sleeve 520 of cartridge 516
(See FIG. 23). Once vein 512 has been optimally positioned, staple
cartridge 516 is clamped around it and secured with clip 522,
illustrated in FIG. 24. Now, distal end 518 of vein 512 is everted
over sleeve 520 and is securely tied with string 524.
79. Referring now to FIG. 25, driver rod 526 is slid into bore 528
of handle 530 and then threadedly engaged with bore 532 of staple
cartride 516. FIG. 26 shows a close-up of staple cartridge 516 as
it appears in its closed position.
80. Moving now to FIG. 27, there is shown driver handle 534 rotated
in a clockwise direction, bringing together anvil 510 and
cylindrical sleeve 520. The clockwise rotation is continued until
the aorta wall 502 is engaged with the distal end 518 of vein 512
upon which the staple driver pins (not visible) are fully engaged
within each of the corresponding staple shafts (not visible),
driving the staples (not visible) through the engaged tissue to
create anastomotic bond 536 between aorta 502 and vein 512 (See
FIG. 28).
81. In another aspect of the present invention, as viewed in FIGS.
29-37 with like numbers referencing like elements, an end-to-side
surgical anastomosis apparatus, generally designated 600, and
procedure for end-to-side anastomosis is provided for stapling an
end 601 of a tubular tissue structure 602 to a side portion of a
luminal structure 603 (FIG. 37). The anastomosis apparatus 600
includes an elongated tubular housing or eversion mandrel,
generally designated 605, defining a central bore 606 extending
longitudinally therethrough and terminating at a bore opening 607
at a distal end of the tubular housing. The central bore 606
includes a transverse cross-sectional dimension sufficiently sized
and configured for receipt of the tissue structure 602 therein in a
manner positioning the end of the tissue structure through the bore
opening. The elongated tubular housing further includes an eversion
support surface, generally designated 608, extending
circumferentially about the bore opening 607 adjacent the distal
end. This surface 608 is configured to retain and support an
everted end 601 of the received tissue structure 602 in a position
facing an intimal surface 610 of the tissue structure 602 in a
radially outward direction. The anastomosis apparatus 600 further
includes an anvil 611 having a fastener engaging surface 612
positioned in the eversion support surface, and a plurality of
fasteners 615 (FIG. 30) coupled to the apparatus. A compression
device, generally designated 613, is included having a shoulder
portion 616 formed for selectively compressing the everted end 601
of the tissue structure 602 and a surface of the luminal structure
603 together against the fastener engaging surface 612. Preferably,
at least one driver pin 617 is provided moveable relative to the
compression device 613 for ejecting the plurality of deformable
fasteners from the compression device, through the everted end of
the tubular tissue structure and the luminal structure to engage
the fastener engaging surface. This engagement deforms the
fasteners and creates an anastomotic bond between the tubular
tissue structure and the luminal structure.
82. While this configuration still requires the end of the grafted
tubular tissue structure 602 to be everted over the distal end of
the mandrel (i.e., the everted end) for positioning against the
eversion support surface 608, the fastener engaging surface 612 of
the anvil 611 is positioned on the eversion support surface 608
adjacent the bore opening 607. Hence, unlike the previous
embodiments of the present invention, the everted end of the
tubular tissue structure is everted over the anvil structure as
well.
83. In this embodiment, the deformable fasteners 615 are preferably
provided by conventional staples formed to pierce through the
tissues to be anastomotized. Other deformable fasteners, however,
could be employed such as deformable clips or the like. Accordingly
fastener engaging surface 612 is preferably provided by a plurality
of pairs of fastener deforming recesses circumferentially spaced
about bore opening 607 (FIGS. 30 and 31). Each deforming recess 612
is similar in function and shape as the fastener deforming recesses
in the embodiment illustrated in FIG. 4. Further, the fastener
engaging surface 612 (i.e., deforming recesses) of this embodiment
is preferably integrally formed and recessed in the eversion
support surface 608 of the mandrel 605. When the everted end 601 of
the tubular tissue structure 602 is resiliently everted over the
mandrel distal end and into supportive contact with the eversion
support surface 608, accordingly, the fastener engaging surface 612
is positioned underneath the adventitial surface 620 of the everted
tissue.
84. The everted end 601 is maintained and retained in the everted
condition against the eversion support surface 608 by the
resiliency of the tubular tissue structure. This is performed by
sufficiently sizing the transverse cross-sectional dimension of the
eversion support surface, relative the transverse cross-sectional
dimension of the tubular tissue structure, for resilient
cooperation therebetween. It is important, however, that the
transverse cross-sectional dimension of the eversion support
surface be sufficiently small to ensure that the structural
integrity of the everted end will not be compromised when everted
over the mandrel distal end.
85. In addition, a securing device may be included to maintain the
everted end of the tubular tissue everted over the end of the
eversion mandrel. For example, a plurality of tines or the like may
protrude outwardly from the eversion support surface which
penetrate and retain the everted tissue over the distal end of the
mandrel in the everted condition. Furthermore, a suture may be
provided to removably secure or tie the everted end to the eversion
support surface.
86. To assure that the fastener engaging surface 612 is positioned
for engagement with the fasteners or staples 615 ejected from the
compression device 613, the recesses 612 are situated at a portion
of the eversion support surface which faces in the direction of the
staple shoulder portion 616. This alignnment enables engagement and
deformation of a respective staple 615 with the respective
deforming recess upon ejection thereof from compression device 613.
In the bell-shaped eversion support surface 608 illustrated in FIG.
32 (to be discussed below), the fastener engaging surface 612 is
situated along a lower annular rim portion 621 of the support
surface 608.
87. Referring now to FIG. 33, it is shown that the central bore is
generally linear extending longitudinally through mandrel 605
parallel to the longitudinal axis thereof. Bore 606 is sufficiently
sized and configured for receipt of the tubular tissue structure
602 therein without substantially deforming or damaging the tissue
structure during loading of the tissue therein, and is of a length
sufficient to accommodate the free graft intended for use. Further,
the central bore terminates at the central bore opening 607 at the
distal end of the eversion mandrel 605. Before eversion of the
everted end of the tubular tissue structure over the distal end of
the eversion mandrel or tubular housing 605, the tubular tissue
structure must be properly positioned in the central bore 606 where
the distal end of the tubular tissue structure protrudes past the
distal end of the eversion mandrel. This extension beyond the
mandrel or tubular housing distal end must be an amount sufficient
to enable the eversion of the tubular tissue structure 602 over the
fastener engaging surface 612 of the anvil 611.
88. To anastomotize attached graft tubular tissue structures having
only one free unattached end, such as an Internal Mammary Artery
(IMA) graft or the like, a side port 622 is provided at a side wall
portion of the eversion mandrel 605 which communicates with the
central bore 606. This port enables the attached graft tissue
structure 602 to enter the central bore from the side of the
eversion mandrel without requiring that the graft be free at both
ends. FIG. 33 best illustrates that the attached graft tissue
structure 602 enter side port 622, extend through central bore 606
and exits bore opening 607 before being everted over the mandrel
distal end for resilient support by eversion support surface 608.
The side port 622 is preferably circular or oval shaped in
cross-sectional dimension, and curving inwardly toward the central
bore. The port, however, may be virtually any other shape which is
sufficiently sized for the passage of the tubular tissue structure
therethrough. It will be understood that both the central bore and
the side port should be free of any sharp edges or the like which
are likely to cause any cutting, nicking or any inadvertent damage
to the loaded tubular tissue structure during operation of the
anastomosis apparatus.
89. To facilitate the delicate placement of the tubular tissue
structure 602 in the elongated central bore 606, the mandrel 605 is
formed to move to an opened condition for increased access and
exposure of all or a substantial portion of the central bore 606.
This is accomplished by providing a clam shell type design for the
lower end portion of the eversion mandrel 605, similar in concept
to the embodiment set forth in FIG. 23. In the preferred
embodiment, the lower end portion of mandrel 605 is divided into a
first half 605' and a second half 605" which are pivotally coupled
together for pivotal movement between an opened condition (FIG. 33)
and a closed condition (FIG. 29). In the open condition, the
mandrel or tubular housing 605 is pivotally opened to expose,
substantially longitudinally, the central bore 606 so that the
tubular tissue structure 602 may be easily positioned therein. In
the closed condition, the lower end portion of the eversion mandrel
closes over the loaded tubular tissue structure to enclose the same
in the central bore 606.
90. The first and second halves 605', 605" are preferably
mirror-images of one another and are semi-cylindrical in shape.
Each eversion mandrel half further defines one half of the central
bore 606 (i.e., a semi-cylindrical first and second bore half 606',
606") which collectively cooperate to form the bore when the
mandrel is moved to the closed condition. The relative pivotal
movement is provided by a longitudinally extending hinge 623 (FIGS.
33 and 34) pivotally coupling the first half 605' to the second
half 605". Preferably, hinge 623 includes an elongated pin or
gudgeon member 625 extending longitudinally along an edge of one of
the mandrel halves generally parallel to the central bore, while
the other mandrel half defines an elongated socket 626 extending
longitudinally along an opposing edge of the same. Each of the
gudgeon member 625 and mating socket 626 are integrally formed with
the respective mandrel half, and each is sized and configured
relative one another for mating pivotal coupling therebetween.
Hence, once slidably coupled, as shown in FIG. 34, the opposing
mandrel halves 605', 605" matingly engage and cooperatively pivot
between the opened condition (FIG. 33) and the closed condition
(FIG. 29).
91. In accordance with the present invention and as will be
described in greater detail below, the compression device 613 is
coupled to eversion mandrel 605 for sliding movement longitudinally
along the mandrel between a released condition (FIG. 33) and a
compressed condition (FIG. 36). Briefly, in the released condition,
the eversion mandrel is permitted to move between the closed
condition and the opened condition, enabling loading of the tissue
structure in the central bore. In the compressed condition, the
staple apparatus 600 selectively compresses an intimal surface 610
of the everted end 601 of the tissue structure 602 to an intimal
surface 627 of the luminal structure 603.
92. To prevent interference with the sliding movement of the
compression device 613 by the hinge 623, the hinge is preferably
recessed from the exterior surface 630 of the mandrel 605. As best
viewed in FIG. 34, both the gudgeon member 625 and the socket 626
are positioned along opposing edge walls 628', 628" of the
respective first and second mandrel halve 605', 605" between the
respective exterior surface 630', 630" and the central bore half
606', 606" thereof. Accordingly, the hinge 623 does not protrude
into the path of the compression device 613 to impede movement as
the assembly slides over the hinge 623 between the released and
compressed conditions.
93. It will be appreciated that a variety of other hinges or
coupling devices could be employed without departing from the true
spirit and nature of the present invention. Moreover, a hinge could
be provided which does protrude into the path of sliding movement
of the compression device (not shown) which would normally impede
the movement to the compressed condition. In this arrangement, the
protruding hinge may function as both a hinge and as a key member
or the like for an alignment mechanism 631 (to be discussed later)
to align movement of the compression device 613 relative the
eversion mandrel 605.
94. To enable pivotal movement of the mandrel halves 605', 605"
between the closed and the opened conditions, at least one of, and
preferably both, the opposing edge walls 628', 628" includes a
tapered wall portion 632', 632" which tapers away from the opposing
edge wall. The collective angle of tapered wall portions 632', 632"
will determine the relative pivotal movement between the mandrel
halves 605', 605" about the hinge member 623. In the preferred
embodiment, these opposing tapered wall portions 632', 632" are
adapted to limit the pivotal movement of the mating halves 605',
605" in the opened condition (phantom lines in FIG. 34) between
about 45.degree. to about 120.degree.. This opening angle need only
be sufficiently large to enable positioning of the attached or free
graft into the exposed central bore 606. Since the diameter of
these grafts are relatively small, the opening angle need not be
very large.
95. Once the tubular tissue structure is properly positioned in the
one side of the semi-cylindrical bore portion, while the eversion
mandrel is in the opened condition (FIG. 33), the mandrel halves
605', 605" are moved to the closed condition (FIG. 29) enclosing
the tubular tissue in the central bore. By positioning the distal
end of the tubular tissue structure 602 beyond the distal end of
the eversion mandrel (FIG. 331, the evened end 601 of the tissue
structure can be everted back over the distal end of the mandrel
either through manually rolling the tissue onto the generally
spherical shaped eversion support surface or through the assistance
of medical instruments.
96. As best shown in FIG. 30, it is imperative that the everted
tissue extend over the anvil 611 so that the fastener engaging
surface 612 is positioned beneath the adventitial surface 620 of
the everted tissue structure. Preferably, the everted end is of a
length sufficient to enable the distal end to terminate at a neck
portion 633 of the eversion support surface 608 which is positioned
rearward of the fastener engaging surface 612. By tapering the neck
portion 633 inwardly from the eversion mandrel exterior surface
630, contact of the tissue structure distal end with the sliding
compression device 613 will be prevented when the compression
device is moved to the compressed condition.
97. When the eversion mandrel is moved to the closed condition, the
transverse cross-sectional dimension of the central passage 635 of
the compression device 613 is sized and dimensioned for
longitudinal sliding receipt of mandrel therein. As above
mentioned, the lower end portion of the eversion mandrel is
slidably received in the central passage 635 of the compression
device 613 between a released condition and a compressed condition.
In the released condition (FIG. 33), the compression device 613 is
moved to a position, relative the eversion mandrel, which will not
impede the movement of the mandrel half 605', 605" between the
opened and closed conditions. Accordingly, in the released
condition, the mandrel half portions can be pivotally moved to the
opened condition so that the attached or unattached grafted tubular
tissue structure can be either loaded or removed from the exposed
central bore 606.
98. In contrast, in the compressed condition, the compression
device 613 is moved slidably and longitudinally along the exterior
surface of eversion mandrel 605 toward the eversion support surface
608 until the tissue structures to be anastomotized are compressed
between the shoulder portion 616 of the compression device 613 and
the eversion support surface 608 of the eversion mandrel. As shown
in FIG. 37, the everted end of the tissue structure 602 mounted to
the distal end of eversion mandrel 605 is moved forwardly through
the surgically formed opening 636 in the side of the luminal
structure 603 until the distal end of the mandrel is positioned in
the luminal structure. It is noted that the surgically formed
opening 636 in the resilient luminal structure is preferably
smaller in cross sectional dimension than that of the eversion
support surface 608. Once the distal end of the mandrel 605 and the
everted tissue structure 601 mounted thereon are positioned in the
luminai structure 603, the two are retracted rearwardly as a unit
until the intimal surface 610 of the everted tissue structure 602
contacts the intimal surface 627 of the luminal structure 603
adjacent the surgically formed opening 636. Due to the resilient
nature of the tissue, circumferential contact between the adjacent
tissue structures is facilitated. Hence, upon proper positioning of
the everted end of the tubular tissue structure and the lower end
of the eversion mandrel through the surgically formed opening 636
(FIGS. 36 and 37), the intimal surface 610 of the everted tubular
tissue structure 602 circumferentially contacts the intimal surface
627 of the luminal structure 603 adjacent the fastener engaging
surface 612. The compression device 613 can then be moved to the
compressed condition, compressing the everted end of the tissue
structure and the tissue of the luminal structure 603 between the
shoulder portion 616 of the compression device 613 and the eversion
support surface 608 of the eversion mandrel 605. Subsequently, the
stapler compression device can be prepared for ejecting or firing
the staples therefrom to form an intimal-to-intimal surface
anastomotic bond.
99. Accordingly, using the method and anastomosis apparatus of the
present invention, the end-to-side anastomotized tissues juncture
will be free of any portion of the fastener protruding into the
lumen of either the graft vessel or target vessel to interfere with
blood flow (FIG. 38) This arrange will reduce the risk of thrombus
formation.
100. Employing a concept similar to the previous embodiments,
compression device 613 includes a disposable circular staple
cartridge 637 encasing a circular array of staple delivery shafts
638. The shafts 638 may be arranged in a plurality of concentric
arrays or rows of staple shafts to best perform these anastomotic
procedures. Although the present invention is primarily described
and depicted as forming staple bonds that are circular and as
having component circumferences that are circular, other
embodiments are realized for forming staple bonds having
elliptical, tear drop, generally oval or other non-circular shapes.
Accordingly, the anvil and associated array of deforming recesses
612 (i.e., the fastener engaging surface 612), and the staple
cartridge 637 and associated staple shaft array of these
alternative stapler embodiments have circumferences in the shape of
the desired staple bond.
101. Referring now to FIGS. 29 and 35, compression device 613 is
shown including a tubular drive housing 640 operatively coupled to
staple cartridge 637 for driving staples from the cartridge 637
into engagement with the fastener engaging surface 612 positioned
on eversion mandrel 605. The drive housing 640 and the staple
cartridge 637 each define a segment of central passage 635 which as
mentioned is formed for sliding receipt of the eversion mandrel
therein,
102. To promote alignment between the array of staple shafts 638
and the corresponding staples 615 therein, and the respective
fastener deforming recesses 612, an alignment mechanism 631 may be
provided operatively positioned between the eversion mandrel and
the compression device 613 and the drive housing 640. Preferably,
as best viewed in FIG. 29, the alignment mechanism 631 is provided
by a key member 641 protruding into the central passage 635 from an
interior wall of the compression device (i.e., either the staple
cartridge 637, the driver housing 640, or both), and a
longitudinally extending groove 642 provided in the exterior
surface of the eversion mandrel 605. The key member 641 is formed
and dimensioned for sliding receipt in the alignment groove 642 for
aligned movement of the staple cartridge 637 relative the eversion
mandrel 605. It will be understood that the eversion mandrel could
include a key member while the compression device defines the
groove, or that any other alignment mechanism could be employed to
align the two components without departing from the true spirit and
nature of the present invention. For example, as set forth above,
the key member could be provided by a protruding hinge member of
the eversion mandrel protruding into the central passage of the
compression device.
103. Mounted to and protruding perpendicularly outward from the
face 643 of drive housing 640 is a plurality staple driver pins 617
aligned in an array (circular in FIGS. 29 and 35) conforming to the
delivery shaft pattern of the staple cartridge 637. Staple
cartridge 637 encases, from end to end, a cylindrical array of
hollow staple delivery shafts 638 each of which hold a preloaded
staple 615. All shafts 638 are identical and each has height and
width dimensions such that a corresponding staple driver pin 617 is
slidable therein. In the configuration of the FIG. 30, due to the
position and orientation of the deforming recesses 612 positioned
on the eversion support surface 608, the staples 615 are preferably
ejected from the cartridge housing at about a 30.degree. to about
60.degree. angle, and most preferably about 45.degree. angle, from
the vertical. This angle assures that the staples penetrate the
tubular tissue and the luminal tissue generally perpendicular
thereto to form a proper anastomotic bond.
104. Each staple shaft 638, thus, will curve inwardly from a
direction parallel to the longitudinal axis of the central passage
635 to the desired angle toward the axis. Hence, to slidable
accommodate such a curvature, the driver pins 617 will have to be
resiliently flexible in nature. For example, the driver pins may be
composed of stainless steel, plastic or the like.
105. The staple cartridge 637 is preferably provided by a
disposable cartridge which is disposed of and replaced after one
anastomotic stapling. This assures that the staple shafts and
central passages are clean, sterile and clear of blockage during
operation. In another embodiment, a slidable sleeve (not shown) may
be provided around the driver pin array to prevent blood and tissue
from getting caught therein.
106. Again, it is imperative not to injure the living tissue being
stapled by overcompressing it between the fastener engaging surface
612 of anvil 611 and the shoulder portion 616 of the staple
cartridge 637, or by a staple bond that is exceedingly tight.
Accordingly, overcompression of the tissue is again prevented in
this embodiment of the present invention by limiting the length of
driver pins 617.
107. Similar to the embodiment of FIG. 7, a threaded proximal end
of eversion mandrel 605 may be provided which extends beyond the
length of the delivery housing 640 (not shown) to threadedly engage
with a nut. This nut may include an internally threaded throughbore
extending the full length of cylindrical nut which allows the
threaded end to exit therethrough.
108. Moreover, an off-set assembly may be employed to control the
movement of the compression device 613 between the compressed
condition and the released condition. Briefly, in this
configuration (not shown; however similar to but in the reverse
direction of the off-set mechanism employed in the embodiment of
FIGS. 17 and 18), eversion mandrel 605 (handle 402) is slidably
received in the central passage 635 of compression device 613
(staple cartridge 418). An off-set housing portion (cylindrical
casing 442) of compression device 613 is movably coupled to and
cooperating with an off-set driver rod (driver rod 406), axially
off-set from eversion mandrel 605, to drive the movement of the
compression device between the released and the compressed
conditions. Similar to the off-set mechanism of FIGS. 17 and 18,
the driving force may be provided by a threaded end (driver rod end
412) or a threaded handle portion (handle 402 at bore 416) whereby
the off-set housing portion of compression device 613 would be
rigidly coupled to the off-set driver rod (driver rod 406).
109. Both the staple cartridge 637 and the delivery housing 640 may
incorporate a clam-shell design in which each housing provides a
semi-cylindrical half portion (637', 637" for cartridge 637, and
640', 640" for delivery housing 640). Each half portion of the
compression device is preferably hingedly mounted together. through
independent hinge members, at a respective edge portion, similar to
the eversion mandrel. The half portions, however, may be simply
snapfit together as well. In either configuration, the half
portions will be independently, or cooperatively, movable between
an opened position (not shown) and a closed position (FIG. 35). In
the opened condition, the respective half portions are
cooperatively pivoted along a pivotal axis of the hinge members,
parallel to the longitudinal axis of the central passage. This
pivotal movement will pivot the corresponding half portions, and
away from one another to expose the central bore 606. The relative
pivotal movement of the housing half portions is by an amount
sufficient to enable receipt of the eversion mandrel 605 in the
central passage 635 when the eversion mandrel is in the closed
condition.
110. In the closed position of the compression device, as
illustrated in FIG. 35, the housing half portions (637', 637" for
cartridge housing 637, and 640', 640" for delivery housing 640) are
enclosed about the loaded eversion mandrel. This arrangement
enables sliding receipt of the eversion mandrel 605 from the
released condition to the compressed condition before firing of the
staples from the staple shafts.
111. To accommodate attached grafts, the delivery housing includes
an elongated delivery slot 645 in alignment with side port 622 of
the eversion mandrel for receipt of the attached end of the graft
therethrough. As best viewed in FIG. 35, slot 645 is sufficiently
sized and configured to enable movement of the delivery housing
between the released and the compressed conditions. Accordingly,
slot 645 is relatively linear and generally extends in a direction
parallel to the mandrel longitudinal axis from one end of the
proximal end to the distal end of the delivery housing.
112. FIGS. 36-38 illustrate the mechanical interaction between the
staple driver pins 617, staple cartridge 637 and eversion mandrel
anvil 611 upon operational engagement therebetween. In accordance
with the present invention, after the graft has been loaded into
the central bore of the eversion mandrel, and the everted end
thereof has been everted over the distal end of the mandrel, the
compression device can be moved to the closed position. In this
configuration, before the assembly is moved to the compressed
condition, the array of staple delivery pins 617 mounted on face
643 of delivery housing 640 are slidably engaged within the array
of staple delivery shafts 638 of staple cartridge 637. The array of
staples 615 is projected from staple cartridge 637 and through the
tissues to be stapled (not shown). Similar to FIG. 9, once the
ciriver pins 617 contact the respective staples 615, the staples
are ejected or fired from the staple shafts and driven through the
tubular tissue structure and the luminal tissue adjacent the
surgically formed opening until the staples contact and are
deformed by the deforming recesses 612 to form an
intimal-to-intimal anastomotic bond.
113. Moreover, a spring-loaded engagement between the compression
device 613 and the eversion mandrel 605 enabling independent
compression of the tissues, and independent stapling thereof is
also preferably applicable for this embodiment of the present
invention. Such a stapler device is illustrated in commonly owned
and co-pending U.S. patent application Ser. No. 08/597,691, filed
Feb. 6, 1996, hereby incorporated by reference in its entirety.
This arrangement enables independent compression of the tissues
between the compression device shoulder portion 616 and the anvil
611 of the eversion mandrel 605 before the firing step commences,
firing or ejecting the staples through the tissues. This assures
that the overcompression of the tissues does not occur during the
firing step.
114. As above-mentioned and as shown in FIG. 32 eversion support
surface 608 may be bell-shaped having a distal end of the eversion
mandrel 605 which tapers outwardly. In this embodiment, the
fastener engaging surface 612 (i.e., the deforming recesses) is
positioned circularly about bore opening 607 on lower annular rim
portion 621. The annular rim portion 621 is oriented generally
perpendicular to the direction of travel of the compression device
613 so that the deforming recesses face the corresponding staple
shafts 638 perpendicularly without requiring any curvature of the
shafts.
115. Similar to the previous embodiment, the everted end of the
tubular tissue structure is everted over the distal end of the
eversion mandrel 605 so that the adventitial surface 620 of the
tissue structure is resiliently supported against the fastener
engaging surface. It will further be appreciated that in either the
generally spherically shaped eversion support surface or the
bell-shaped eversion support surface, the transverse
cross-sectional dimension of the eversion support surface 608 is
larger than the transverse cross-sectional dimension of the central
passage 635. This arrangement prevents the compression device from
slipping past the end of the eversion support surface when the
mandrel is operatively positioned in the compressed condition
(FIGS. 32 and 36).
116. It will be understood that the foregoing is only illustrative
of the principles of the present invention, and that various
modifications can be made by those skilled in the art without
departing from the scope and spirit of the invention. For example,
the particular stapler structural configurations shown are not
critical and other configurations can be used if desired. One
possible alternative for the configuration illustrated in FIG. 17
is to have a vessel rod that is retractable (e.g., by means of a
telescoping rod). In addition, the vessel rod of this alternative
embodiment can be curved to facilitate the anastomotic procedure if
necessary. Also, the structure and method of the present invention
can be employed thoracoscopically.
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