U.S. patent application number 10/683797 was filed with the patent office on 2004-05-20 for means and method for performing an anastomosis.
Invention is credited to Christakis, George, Spence, Paul A., Williamson, Warren P. IV.
Application Number | 20040097992 10/683797 |
Document ID | / |
Family ID | 24870770 |
Filed Date | 2004-05-20 |
United States Patent
Application |
20040097992 |
Kind Code |
A1 |
Spence, Paul A. ; et
al. |
May 20, 2004 |
Means and method for performing an anastomosis
Abstract
An anastomosis is performed using a mounting structure mounted
on the outside of at least one vessel. The mounting structure
includes a flexible mounting structure that is attached to the
vessel by a special instrument. A graft vessel is attached to the
mounting structure either directly or by means of another mounting
structure attached to the graft vessel. Tools for attaching a
mounting structure to a vessel are disclosed, and a tool for
attaching two mounting structures together is also disclosed.
Methods for carrying out the anastomosis according to the invention
are also disclosed.
Inventors: |
Spence, Paul A.;
(Louisville, KY) ; Williamson, Warren P. IV;
(Loveland, OH) ; Christakis, George; (Toronto,
CA) |
Correspondence
Address: |
JOHN K. UILKEMA
THELEN REID & PRIEST LLP
P.O. BOX 190187
SAN FRANCISCO
CA
94119-0187
US
|
Family ID: |
24870770 |
Appl. No.: |
10/683797 |
Filed: |
October 10, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10683797 |
Oct 10, 2003 |
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09892235 |
Jun 26, 2001 |
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6652543 |
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09892235 |
Jun 26, 2001 |
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09200796 |
Nov 27, 1998 |
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6254617 |
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09200796 |
Nov 27, 1998 |
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08714615 |
Sep 16, 1996 |
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5868763 |
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Current U.S.
Class: |
606/153 |
Current CPC
Class: |
A61B 17/11 20130101;
A61B 17/1152 20130101; A61B 2017/1139 20130101; Y10S 623/903
20130101; A61B 2017/1135 20130101 |
Class at
Publication: |
606/153 |
International
Class: |
A61B 017/08 |
Claims
1. An anastomotic device comprising: A) a first malleable mounting
structure mounted on a first vessel; B) a second malleable mounting
structure mounted on a second vessel; C) fastener means for
fastening said first mounting structure to said second mounting
structure; and D) means in each mounting structure for maintaining
the mounting structure associated therewith in a selected shape so
a desired flow area and shape can be established at the junction of
said first and second vessels:
2. An anastomotic device comprising means for placing an inside
edge surface of an incision in a first vessel in abutting contact
with an inside edge surface of an incision in a second vessel so
the vessels heal together at the inside edge surfaces of the
vessels, and a hemostatic medium, a stiffening framework having
essentially no material memory, means for attaching said stiffening
framework to said body, and means for attaching said body to
vessels, said means for attaching said body to vessels including
pins.
3. The anastomotic device defined in claim 1 wherein each mounting
structure further includes means for mounting each mounting
structure on the vessel associated therewith adjacent to an
incision in the vessel and for placing an inside edge of the first
vessel immediately adjacent to the incision in said first vessel in
healing contact with an inside edge of the second vessel
immediately adjacent to the incision in said second vessel.
4. The anastomotic device defined in claim 1 wherein said first and
second vessels are in side-to-side contact with each other.
5. The anastomotic device defined in claim 1 wherein said first and
second vessels are in end-to-side contact with each other.
6. The anastomotic device defined in claim 1 wherein each of said
first and second mounting structures includes a flexible body, and
means for attaching said body to a vessel.
7. The anastomotic device defined in claim 6 wherein said means for
attaching said body to a vessel includes retention means.
8. The anastomotic device defined in claim 7 further including
means for placing said retention means in said vessel.
9. The anastomotic device defined in claim 8 wherein said means for
placing said retention means includes an anvil.
10. The anastomotic device defined in claim 9 wherein said anvil
includes a curved surface for turning said staples.
11. The anastomotic device defined in claim 2 wherein said first
and second vessels are in side-to-side contact with each other.
12. An anastomotic device comprising a mounting structure mounted
on the outside of a first vessel adjacent to an incision and on the
outside of a second vessel adjacent to an incision in the second
vessel.
13. The anastomotic device defined in claim 12 further including
means connecting said mounting structure to said vessels in
position so that an inside edge of said first vessel immediately
adjacent to the incision in said first vessel is in healing contact
with an inside edge of said second vessel immediately adjacent to
the incision in said second vessel.
14. The anastomotic device defined in claim 1 wherein said means in
each mounting structure for maintaining the mounting structure in a
selected shape includes a sinuous stiffening element.
15. The anastomotic device defined in claim 1 wherein each mounting
structure is mounted adjacent to an incision in the vessel
associated therewith and said flow area is larger than the area of
one of said vessels whereby said one vessel is enlarged when said
mounting structures are fastened together.
16. The anastomotic device defined in claim 15 wherein said means
in each mounting structure for maintaining the mounting structure
in a selected shape enlarges the incision in one vessel and
decreases the size of the incision in the other vessel.
17. The anastomotic device defined in claim 2 wherein said first
and second vessels are in end-to-side contact with each other.
18. The anastomotic device defined in claim 1 further including a
blood flow passage defining means in one of said vessels for
maintaining blood flow while said mounting structures are being
mounted to said vessels and fastened to each other.
19. The anastomotic device defined in claim 2 further including a
blood flow passage defining means in one of said vessels for
maintaining blood flow while the inside edge of the one vessel is
being placed in abutting contact with the inside edge of the second
vessel.
20. A device for performing an anastomosis comprising: A) a body
having a channel defined therein; B) a linkage attached at one end
thereof to said body; and C) a driver means attached to another end
of said linkage to be operated by said linkage for fastening a
mounting structure to a vessel.
21. The device defined in claim 20 further including an anvil
having a body sized to be received in said channel and a head which
is inserted into a vessel.
22. The device defined in claim 21 wherein said head includes a
means for defining a blood flow passage.
23. The device defined in claim 22 wherein said head further
includes means for turning staples.
24. The device defined in claim 23 wherein said driver means
includes a staple engaging surface.
25. The device defined in claim 24 wherein said mounting structure
engaging surface is V-shaped in cross sectional shape.
26. The device defined in claim 23 wherein said driver means
includes an arcuate vessel engaging surface.
27. The device defined in claim 21 further including a second
anvil.
28. The device defined in claim 27 wherein said second anvil
includes a portion which is received inside a vessel via an end of
said vessel.
29. The device defined in claim 1 wherein said mounting structures
are hourglass-shaped.
30. The device defined in claim 29 further including staples in
each of said mounting structures and a retention band in one of
said mounting structures.
31. The device defined in claim 30 wherein said retention band has
virtually no material memory.
32. The device defined in claim 2 wherein said means for attaching
said hemostatic medium to vessels includes means for moving the
vessels towards each other.
33. The device defined in claim 32 wherein said means for moving
the vessels toward each other includes a malleable bridge.
34. A method of performing an anastomosis comprising: A) defining
an incision in a first vessel; B) defining an incision in a second
vessel; C) positioning a first mounting structure on the first
vessel adjacent to the incision in the first vessel so that the
inner edge of the first vessel adjacent to the incision therein is
spaced from an inner edge of the first mounting structure; D)
fastening the first mounting structure to the first vessel; E)
positioning a second mounting structure on the second vessel
adjacent to the incision in the second vessel so that the inner
edge of the second vessel adjacent to the incision therein is
spaced from an inner edge of the second mounting structure; F)
fastening the second mounting structure to the second vessel; and
G) attaching the first and second mounting structures together.
35. The method defined in claim 34 wherein the step of attaching
the first and second mounting structures together includes
positioning the inner edges of the vessels in abutting contact with
each other after said attaching steps.
36. An anastomotic device comprising: A) a stent located on a
vessel to be joined to another vessel; B) means for shaping said
stent; and C) vessel attaching means on said stent for attaching
said stent to the vessel.
37. The method defined in claim 34 wherein the step of shaping the
fastened mounting structures includes defining a flow area which
exceeds a cross sectional area defined by one of the vessels prior
to said attaching step.
38. The method defined in claim 34 further including a step of
positioning the vessels in side-to-side orientation prior to said
attaching step.
39. The method defined in claim 34 further including a step of
positioning the vessels in end-to-side orientation prior to said
attaching step.
40. The anastomotic device defined in claim 2 wherein each of said
first and second mounting structures includes a flexible body, and
means for attaching said body to a vessel.
41. The method defined in claim 34 further including a step of
maintaining blood flow through one of the vessels.
42. The method defined in claim 36 further including a step of
maintaining blood flow through one of the vessels.
43. A method of performing an anastomosis comprising: A) defining
an incision in a first vessel; B) defining an incision in a second
vessel; C) positioning a mounting structure on the first vessel
adjacent to the incision in the first vessel so that the inner edge
of the first vessel adjacent to the incision therein is spaced from
an inner edge of the mounting structure; D) fastening the mounting
structure to the first vessel; E) positioning the second vessel
adjacent to the mounting structure so that an inner edge of the
second vessel adjacent to the incision therein is spaced from an
inner edge of the mounting structure; F) fastening the mounting
structure to the second vessel; and G) shaping the fastened
mounting structure to define a desired flow area between the first
and second vessels.
44. The method defined in claim 43 further including positioning
the inner edges of the vessels in abutting contact with each other
prior to said shaping step.
45. A method of performing an anastomosis comprising: A) defining
an incision in a first vessel; B) defining an incision in a second
vessel; C) fastening a mounting structure to each vessel adjacent
to each incision; and D) shaping said mounting structure to define
a desired flow area and shape for the junction of the two
vessels.
46. A method of performing an anastomosis comprising: maintaining
blood flow in a vessel; defining an incision in the vessel;
fastening a stent on the outside of the vessel; and shaping the
stent.
47. The method defined in claim 46 further including stabilizing
the vessel during the step of fastening the stent.
48. The method defined in claim 42 further including a step of
drawing the vessels together.
49. The method defined in claim 42 further including a step of
stabilizing the first vessel.
50. The method defined in claim 42 further including a step of
positioning the inside edges of each vessel in abutting contact
with each other.
51. The method defined in claim 34 further including shaping the
fastened mounting structures to define a desired flow area between
the first and second vessels.
52. An anastomotic device comprising: A) a hemostatic medium; B) a
stent located on the outside of one vessel which is to be joined to
another vessel; and C) means for bringing vessel walls of said one
vessel into intimate approximation with other vessel walls of said
another vessel.
53. The anastomotic device defined in claim 40 wherein said means
for attaching said body to a vessel includes retention means.
54. The anastomotic device defined in claim 36 further including a
hemostatic medium.
55. The anastomotic device defined in claim 36 wherein said stent
is located on the outside of the vessel.
56. The anastomotic device defined in claim 36 wherein said vessel
attaching means includes staples.
57. An anastomotic device comprising: A) a first malleable frame
mounted on a first vessel; B) a second malleable frame mounted on a
second vessel; C) fastener means for fastening said first malleable
frame to said second malleable frame; and D) means in each
malleable frame for maintaining the malleable frame associated
therewith in a selected shape so a desired flow area and shape can
be established at the junction of said first and second
vessels.
58. The anastomotic device defined in claim 57 further including a
living hinge located at a junction formed between the first and
second vessels.
59. The anastomotic device defined in claim 57 wherein said
fastener means include tissue retention pins that are staggered
with respect to each other.
60. The anastomotic device defined in claim 57 wherein the junction
formed between the two vessels is sinuous in shape.
61. The anastomotic device defined in claim 53 further including
means for placing said retention means in said vessel.
62. The anastomotic device defined in claim 62 wherein said means
for placing said retention means includes an anvil.
63. The anastomotic device defined in claim 62 wherein said anvil
includes a curved surface for turning said staples.
64. The anastomotic device defined in claim 2 wherein said means in
each mounting structure for maintaining the mounting structure in a
selected shape includes a sinuous stiffening element.
65. The anastomotic device defined in claim 2 wherein each mounting
structure is mounted adjacent to an incision in the vessel
associated therewith and said flow area is larger than the area of
one of said vessels whereby said one vessel is enlarged when said
mounting structures are fastened together.
66. The anastomotic device defined in claim 2 further including a
blood flow passage defining means in one of said vessels for
maintaining blood flow while said mounting structures are being
mounted to said vessels and fastened to each other.
67. A device for performing an anastomosis comprising: A) a member
for supporting a malleable stent; B) an anvil for controlling
tissue fastening elements and for controlling vessel tissue during
fastening; and C) means for shaping said stent in situ on the
vessel.
68. The anastomotic device defined in claim 36 wherein said vessel
attaching means includes means for bringing vessel walls into
approximation.
69. The method defined in claim 46 further including steps of
performing multiple grafts.
70. The anastomosis device defined in claim 36 further including a
second stent located on the first-mentioned vessel and spaced from
said first-mentioned stent whereby multiple grafts can be effected.
Description
TECHNICAL FIELD OF THE INVENTION
[0001] The present invention relates to the general art of surgery,
and to the particular field of means and methods associated with
anastomoses.
BACKGROUND OF THE INVENTION
[0002] In the United States, there are currently as many as 300,000
coronary artery bypass graft (CABG) procedures performed on
patients annually. Each of these procedures may include one or more
graft vessels which are hand sutured. Until recently, coronary
artery bypass procedures have been performed with the patients on
cardiopulmonary bypass whereby the heart is stopped with
cardioplegia and the surgery is performed on an exposed, stationary
heart.
[0003] The vast majority of CABG procedures performed currently are
accomplished by opening the chest wall to gain access to the
coronary vessels. Through the use of heart lung bypass machines and
a drug to protect the heart muscle, the heart is stopped and
remains still during the procedure. In this setting, the surgeon
has ample time and access to the vessels to manipulate hand
suturing instruments such as forceps, needle holders and
retractors.
[0004] However, with increasing costs of hospital stays and
increased awareness by patients of other minimally invasive
surgical procedures, interest in developing a minimally invasive
CABG procedure is increasing. Hospitals need to reduce costs of
procedures and patients would like less post-operative pain and
speedier recovery times.
[0005] In the past, two significant developments in the technology
played a major role in advancing the whole area of cardiac surgery.
The heart-lung machine was invented in the 1950's but underwent
significant improvement in design to become a reliable clinical
device in the 1960's. The heat-lung machine allows the surgeon to
take the heart out of the blood circulation system to work on it in
isolation.
[0006] The second major development was in myocardial protection.
When the heart was isolated from the circulation, it was no longer
perfused. After twenty to thirty minutes of ischemia, irreparable
damage occurred and no matter how good the repair, the heart
function was frequently inadequate to allow the patient to survive.
Cardioplegia, a solution which is generally cold and high in
potassium, changed everything. This development occurred in the
1970's. This allowed very satisfactory protection of the heart so
the surgeon could perform an unhurried repair and still expect the
heart to work afterward.
[0007] A secondary consequence of these developments was the
decline in interest in technology to facilitate heart surgery. When
speed of the surgery was initially of utmost importance, all sorts
of developments were proposed to speed surgery. Therefore, the art
in the 1960's and 1970's contained numerous examples of such
devices.
[0008] Now with an increased incentive to reduce costs, there is a
renewed interest in redesigning cardiothoracic procedures. A few
pioneering surgeons are now performing minimally invasive
procedures whereby the coronary artery bypass is performed through
a small incision in the chest wall. There are some surgeons that
believe that the best way to perform a minimally invasive coronary
artery bypass procedure is to perform the procedure on a beating
heart, i.e., without heart-lung bypass and cardioplegia. This
minimizes the time it takes to perform the procedure and reduces
the cost of the operation by eliminating the heart lung bypass
machine.
[0009] In the case of minimally invasive procedures on a beating
heart, the surgeon starts by making a mini-thoracotomy between the
fourth and fifth ribs and, sometimes, removing the sternal
cartilage between the fourth or fifth rib and the sternum. The
space between the fourth and fifth ribs is then spread to gain
access to the internal mammary artery (IMA) which is dissected from
the wall of the chest. After dissection, it is used as the blood
supply graft to the left anterior descending artery of the heart
(LAD). Below the IMA lies the pericardium and the heart. The
pericardium is opened exposing the heart. At this point, the LAD
may be dissected from the fissure of the heart and suspended up
with soft ligatures to isolate the artery from the beating heart.
Some companies are making a special retractor to gently apply
pressure to the heart muscle to damp the movement right at the LAD.
A small arteriotomy is performed in the LAD and the graft IMA is
sutured to the LAD.
[0010] Traditionally, to gain access to the cardiac vessels to
perform this procedure the sternum is sawn in half and the chest
wall is separated. Although this procedure is well perfected the
patient suffers intense pain and a long recovery.
[0011] Until recently all bypass graft procedures have been
performed by hand suturing the tiny vessels together with extremely
fine sutures under magnification. The skills and instruments
required to sew extremely thin fragile vessel walls together have
been perfected over the last twenty years and are well known to the
surgical community that performs these procedures.
[0012] In the `open chest` surgical setting, the surgeon has
adequate access and vision of the surgical site to manipulate the
anatomy and instruments.
[0013] The push for less invasive surgical approaches is fueling
interest in many areas that were abandoned long ago--including that
of coronary fastening and valve replacement. The inventors have
thus identified a need for a device and a method to perform CABG
surgery on a beating heart.
[0014] Some surgeons are attempting minimally invasive CABG
procedures using femoral artery bypass access rather than opening
the chest for bypass via the aorta. However, since use of
cardioplegia requires additional support and expense during the
anastomosis procedure, the inventors believe that it is best to
attempt to fasten the anastomosis while the heart is beating.
However, this procedure when performed with a hand suturing
technique is very imprecise due to the translation of movement from
the beating heart to the suspended artery. This may cause imprecise
placement of the suture needles. Any imprecise placement of the
sutures may cause a distortion of the anastomosis which may cause
stenosis at this junction. The sutures used for this procedure are
extremely fine (0.001" in diameter) and are placed less than 1 mm
apart.
[0015] As one can imagine it is difficult enough to place suture
needles the size of a small eyelash into a vessel wall with
placement accuracy of better than 1 mm. To accomplish this feat of
precision on a moving target is extremely difficult. To make
matters worse, the site is often bloody due to the fact that the
heart has not been stopped.
[0016] Therefore, there is a need for a means and method which
permits the forming of a precise anastomosis without requiring the
stopping of a beating heart. Still further, there is a need for
performing such an anastomosis in a minimally invasive manner.
[0017] The current method of hand suturing is inadequate for the
following reasons:
[0018] On a beating heart it may be difficult to place the sutures
with the position precision required. In a beating heart procedure
the surgeon can attempt to minimize the deleterious effects of the
movement by using suspension or retraction techniques. However, it
is impossible to isolate all movement of the vessel during an
anastomosis procedure.
[0019] Methods that attempt to stabilize and isolate the artery
from the movement of the beating heart can damage the vessel or
cause myocardial injury (MI).
[0020] In addition to the problem of placing sutures accurately one
must make an incision through the artery wall to open the artery.
This too is a delicate procedure even on a still heart because the
incision must be of a precise length. It is also critical to not
penetrate the back wall or side wall of the vessel which will lead
to complications. The placement of the initial incision is of
paramount importance. The surgeon must pick a suitable location
free from calcium deposits, fat and side branches.
[0021] Without cardioplegia, one must also provide blood flow to
the heart muscle while the heart is beating, therefore, after the
initial arteriotomy, the surgical field is very bloody and
obscured.
[0022] Access to the heart vessels other than the LAD will be
extremely difficult with minimally invasive hand suturing due to
the anatomical location of the posterior wall of the heart.
[0023] Although minimally invasive CABG procedures are taking place
now with sutured anastomosis they require superlative skills and
are therefore not widely practiced.
[0024] One of the most vexing problems is that of adequate access.
The procedure takes place through an access site created between
two ribs. The ribs cannot be spread too far without risk of
breaking and the heart lies deep within the chest. The access is
through a small, long, dark tunnel. The surgeon must then
manipulate his tools down this tunnel without obscuring his
vision.
[0025] If special tools are constructed to allow the surgeon to be
able to hold suture needles on the end of a long instrument, the
added length of the tool only amplifies any inaccurate
manipulation. The same holds true for any special suturing devices
contemplated.
[0026] If the sutures are not placed correctly in the vessel walls,
bunching or leaks will occur. In the minimally invasive procedure
this is disastrous, usually resulting in the conversion to an open
chest procedure to correct the mistake. Any rough handling of the
vessel walls is detrimental as inflammation can cause further
postoperative complications.
[0027] The anastomosis must seal leak tight to prevent
exsanguination. Therefore, any improvement over sutures must
provide a leak free seal in a very confined space, yet should
provide proper flow areas in the vessel after healing is
complete.
[0028] As is apparent from the above discussion, it is necessary to
find a way to control the beating heart movement of the vessel
while performing the anastomosis in such a way that still allows
for exact placement of the fastening means.
[0029] While the art contains disclosures of several devices that
are used to join blood vessels, these devices are primarily
directed to an end-to-end anastomosis, which is inadequate for CABG
procedures. Furthermore, the techniques disclosed in the prior art
often require the vessels to be severely deformed during the
procedure. The deformation may be required to fit the vessels
together or to fit a vessel to an anchoring device. One cannot just
slit the tissue and pull it through a ring to anchor it on a
flange. Pulling or stretching the vessel walls produces a very
unpleasant and unexpected result. Vessel walls are made of tissue
fibers that run in the radial direction in one layer and the
longitudinal direction in another layer. In addition the elasticity
of the tissue fibers in the longitudinal direction is greater than
those that run radially. Therefore, the tissue will not stretch as
easily in the radial or circumferential direction and results in a
narrowing or restriction when pulled or stretched in the prior art
devices. Vessel walls also have a layer of smooth muscle cells that
can spasm if treated harshly. Such manhandling will result in
restrictions and stenotic junctions because the vessel walls will
react poorly to being treated in such a rough manner and the
stretching of the vessel wall will telegraph up the vessel wall due
to the high radial stiffness of the vessel structure, causing
restrictions and spasms in the vessel wall. The prior art fails to
teach that the vessels are living tissue and must not be made to
conform to rigid fitting-like shapes. Therefore, there is a need
for an anastomotic technique that permits handling of blood vessels
in a manner that is not likely to cause those blood vessels to
react poorly.
[0030] Additionally, prior art systems fail to teach methods of
ensuring hemostasis so as not to have leakage under pressure. It is
noted that mechanical devices used to join blood vessels are
extremely difficult to seal. No attempt has been made in the prior
art to include a hemostatic medium in conjunction with an
anastomotic device. Prior art devices are directed to accomplishing
hemostasis through excessive clamping forces between clamping
surfaces or stretching over over-sized fittings.
[0031] In order to effect good healing, healthy vessel walls must
be brought into intimate approximation. This intimate approximation
is now accomplished by the skilled hands of a surgeon with sutures.
A vascular surgeon is taught how to suture by bringing the vessel
edges together with just the right knot tightness. Too loose and
the wound will leak and have trouble healing causing excessive scar
tissue to form. Too tight will tear through the delicate tissue at
the suture hole causing leaks. The key is to bring the edges
together with just the right amount of intimate approximation
without excessive compression.
[0032] It must be further noted that the junctions taught in the
prior art are not anatomically correct both for blood flow and for
healing. A well made anastomotic junction is not made in a single
plane and should accurately follow blood vessel geometry. The
junction is more of a saddle shape, and the cross section is not
necessarily a circle. The junction where the vessel units join is
not a constant cross section angle, but an angle that varies
continuously throughout with respect to any linear reference. In
addition, the length of the junction should be many times the width
of the opening in order to assure a low blood flow pressure
gradient in the junction and to assure a proper flow area. In fact,
the best results are obtained if the confluence area is actually
oversized. The prior art junctions do not account for such flow
characteristics and parameters and are thus deficient. Therefore,
there is a need for an anastomotic technique which can establish
proper flow characteristics and parameters and that accurately
preserves blood vessel geometry, specifically the plural planar
nature in which the junction occurs. Furthermore, most anastomoses
are made between vessels that are not similar in size. It is
therefore necessary to provide a means and method which allow for
the accommodation and joining of dissimilarly sized vessels.
[0033] In addition, the inventors have found through post surgical
follow-up that the supply vessels grow in diameter to accommodate
their new role in providing oxygenated blood to the heart;
therefore, there is a need to provide an oversized junction to
accommodate any increase in the dimension of the graft vessel size.
With a rigid ring that is a singular circular cross section of the
graft, the fitting does not allow the vessel to provide this
increase in flow as the vessels expand to meet the needs of the
heart muscle. Still further, the inside lining of the vessel walls
(intima) should make contact with each other to have proper
healing. The walls of the vessels must come together with just the
right amount of approximation to promote good healing. If the
incised edges are too far apart scarring will occur causing
restrictions. The walls cannot be compressed between two hard
surfaces which will damage the vessels. The prior art teaches
plumbing-like fittings clamped onto vascular structures. However,
clamping and compressing the vessel walls too tightly will cause
necrosis of the vessel between the clamps. If necrosis occurs the
dead tissue will become weak and most likely cause a failure of the
joint. Still further such rings and tubes used to clamp vessels
together do not follow the correct anatomical contours to create an
unrestricted anastomosis. Failing to account for the way healing of
this type of junction occurs, and not accounting for the actual
situation may cause a poor result. A suture technique has the
advantage of having the surgeon making on-the-fly decisions to add
an extra suture if needed to stop a leak in the anastomosis. In a
mechanical minimally invasive system it will not be possible to put
an `extra suture throw` in so the system must provide a way to
assure complete hemostasis. Being a mechanical system the
approximation will not be 100% perfect. And since the design errs
on the side of not over-compressing the tissue there may be very
small areas that may present a leak between the edges of the vessel
walls. Accordingly healing with prior art techniques using
mechanical joining means is not as efficient as it could be.
Therefore, there is a need for an anastomotic technique that
accounts for the way healing actually occurs and provides proper
structural support during the healing process.
[0034] When vascular integrity is interrupted the body quickly
reacts to reestablish hemostasis. Circulating blood platelets are
quickly mobilized to the injury site and initiate and support the
coagulation sequence that leads to the formation of a fibrin plug
at the site of injury. Large breaks in vessel walls which are under
pressure cannot be effectively sealed by platelets and fibrin
without a substrate to collect on. It is critical that the junction
of an anastomosis bring two healthy vessel surfaces in close
approximation to provide an optimal region for vessel repair and
healing, minimizing the distance between healthy endothelial cells
on either side of the junction. This allows for the natural control
processes which prevent platelet aggregation from extending beyond
the area of injury. A more detailed description of the clot
limiting process and the healing process can be found in various
reference texts, such as "Coagulation: The Essentials", by
Fischbach, David P and Fogdall, Richard P, published by Williams
and Wilkins of Baltimore in 1981, the disclosure of Chapter 1
thereof being is incorporated herein by reference.
[0035] Still further, some vessels are located or sized in a manner
that makes placing elements thereon difficult. In such a case, the
fewer elements used to perform an anastomosis the better.
Therefore, there is a need for a means and a method for performing
an anastomosis that can be effected without the need of a
hemostatic medium.
[0036] Many time when a CABG operation is undertaken, the patient
has multiple clogged arteries. At the present time, the average
number of grafts is 3.5 per operation. When multiple grafts are
performed, there is sometimes the opportunity to use an existing or
newly added supply vessel or conduit for more than one bypass
graft. This is known as a jump graft, whereby the conduit, at the
distal end thereof is terminated in a side-to-side anastomosis
first, with an additional length of conduit left beyond the first
junction. Then, an end of the conduit is terminated in an
end-to-end junction. This saves time and resources and may be
necessary if only short sections or a limited amount of host graft
material is available.
[0037] At the present time, existing means and methods of
performing an anastomosis do not permit the formation of multiple
anastomotic sites on a single graft vessel such at both proximal
and distal ends. Thus a surgeon will have to use multiple tools to
perform multiple anastomoses. This will be either impossible or
very expensive.
[0038] Therefore, there is a need for a means and a method for
performing an anastomosis which will lend itself to efficient and
cost-effective multiple by-pass techniques.
[0039] Therefore, there is also a need for a means and a method for
performing an anastomosis which will lend itself to efficient and
cost-effective jump graft techniques.
[0040] As discussed above, performing a sutured anastomosis in a
minimally invasive manner while the patient's heart is beating
requires an extremely high degree of dexterity. Any instrument used
in such a procedure must therefore be as easy and efficient to use
as possible whereby a surgeon can focus most of his attention on
the anastomosis site. The instrument should thus reflect the
above-discussed needs as well.
[0041] Still further, any instrument used in such a procedure must
be amenable to efficient manufacture.
OBJECTS OF THE INVENTION
[0042] It is a main object of the present invention to provide a
means and method of performing an anastomosis without stopping the
patient's heart.
[0043] It is also an object of the present invention to provide an
instrument which can be used to efficiently, accurately and
effectively form a proper anatomically correct anastomosis.
[0044] It is another object of the present invention to provide an
instrument which can be used to efficiently, accurately and
effectively form a proper anastomosis without stopping the
patient's heart.
[0045] It is another object of the present invention to provide a
means and method of performing an anastomosis without stopping the
patient's heart in a minimally invasive manner.
[0046] It is another object of the present invention to provide a
means and method of performing an anastomosis without stopping the
patient's heart in a minimally invasive manner in which the blood
vessels are joined together in such a way as to most efficiently
promote healing.
[0047] It is another object of the present invention to provide a
means and method of performing an anastomosis without stopping the
patient's heart in a minimally invasive manner in which the blood
vessels are joined together without squeezing, compressing or
otherwise manhandling them.
[0048] It is another object of the present invention to provide a
method and means to stabilize a vessel while performing an
anastomotic procedure.
[0049] It is another object of the present invention to provide a
means and method of performing an anastomosis without stopping the
patient's heart in a minimally invasive manner in which the blood
vessels are joined together to form a confluence area that
accurately accounts for flow characteristics and flow
parameters.
[0050] It is another object of the present invention to provide a
means and method of performing an anastomosis without stopping the
patient's heart in a minimally invasive manner in which blood
vessels can be joined together in a side-to-side configuration.
[0051] It is another object of the present invention to provide a
means and method of performing an anastomosis without stopping the
patient's heart in a minimally invasive manner in which blood
vessels can be joined together in an end-to-side configuration.
[0052] It is another object of the present invention to provide a
means and method of performing an anastomosis without stopping the
patient's heart in a minimally invasive manner in which blood
vessels can be joined together to form a junction that is
anatomically correct and accurately reflects blood vessel geometry
at the junction.
[0053] It is another object of the present invention to reduce
tissue inflammation and necrosis due to mishandling and over
compression.
[0054] It is another object of the present invention to provide a
means to hold the edges of the vessel walls in close approximation
to promote healing with a minimum of scarring.
[0055] It is another object of the present invention to provide an
anastomotic stapling device that provides blood flow to the heart
while making the anastomosis.
[0056] It is another object of the invention to provide an
anastomotic stapling device that obviates bunching of the tissue
due to imprecise placement of fasteners.
[0057] It is another object of the invention to provide an
anastomotic device that is amenable to efficient manufacture.
[0058] It is another object of the present invention to provide an
anastomotic means and method which can join dissimilarly sized
vessels.
[0059] It is another object of the present invention to provide an
anastomotic means and method which will accommodate joining vessel
walls at a junction angle that varies with respect to a reference
line.
[0060] It is another object of the present invention to provide an
anastomotic means and method that has a living hinge at a junction
site.
[0061] It is another object of the present invention to provide an
anastomotic means and method which can effect a junction without a
hemostatic medium.
[0062] It is another object of the present invention to provide an
anastomotic means and method which can be used in proximal
junctions and in multiple anastomotic sites on the same vessel.
[0063] It is another object of the present invention to provide an
anastomotic means and method which can be used in a means and a
method for performing an anastomosis which will lend itself to
efficient and cost-effective multiple by-pass techniques.
[0064] It is another object of the present invention to provide an
anastomotic means and method which can be used in a means and a
method for performing an anastomosis which will lend itself to
efficient and cost-effective jump graft techniques.
[0065] It is another object of the present invention to provide an
anastomotic means and method which is especially well suited for
all types of blood vessel anastomosis procedures and techniques,
such as, but not limited to, proximal, side-to-side, end-to-side,
jump grafts as well as others that will occur to those skilled in
the art based on the teaching of the present disclosure.
SUMMARY OF THE INVENTION
[0066] When a patient shows symptoms of cardiac insufficiency which
are not severe enough to warrant surgical intervention, the
cardiologist is called on to clean out or open up the clogged
arteries. One way to open the artery is to install an internal
stent such as disclosed in U.S. Pat. No. 5,425,739. This stent is a
prop that is most often configured like a cylindrical cage. The
stent is delivered to the site over a balloon catheter. When in
place, the catheter is inflated, expanding the stent which in turn
holds or props open the narrowed artery. Since the stent is made of
a material that has no material memory, it will retain the shape
determined by the inflation of the balloon. The balloon is removed
from the artery and the stent stays inside the artery. Such
memoryless material is suitable for use for a bridge and for the
stiffening framework discussed above.
[0067] The present invention uses a similar concept, however, the
"stent" is external to the blood vessel wall. It has the similar
function of holding the vessels open, but is also used as the means
for joining the vessels. The external "stent" is the cuff discussed
above.
[0068] The above-mentioned objects, as well as additional objects
as will occur to one skilled in the art based on the teaching of
the present disclosure, are achieved by a minimally invasive means
and method for forming a precise and anatomically accurate
anastomosis on a patient without requiring the patient's heart to
be stopped using an instrument that precisely places fasteners on
the outside surface of a blood vessel in a position to cause the
anastomosis to have a proper flow area and to accurately reflect
the geometry of the junction and which positions the inside edges
of the incised blood vessels in abutting contact with each other
whereby proper healing is promoted. The means and method of the
present invention also provide the ability to create an oversized
junction which will accommodate future anticipated growth of the
vessels. The means and method of the present invention accomplish
this without requiring the mishandling of the blood vessels, and
can be used for side-to-side anastomoses as well as end-to-end
anastomoses. The device is also amenable to efficient
manufacture.
[0069] In addition, these objects are accomplished by providing a
flexible hemostatic medium to hold a malleable stiffening
framework. The hemostatic media can be absorbable material or a
fabric material that allows tissue ingrowth. The medium provides a
supportive surface at the edges of the anastomosis for the natural
vessel repair process.
[0070] Therefore, to address the need of hemostasis, the inventors
have included a cuff material which can be made from a variety of
materials to allow the anastomosis to perform in a leak free manner
with the proper substrate for healing to occur. It is also
anticipated that through more development, a special coating such
as collagen coatings could be incorporated into the hemostatic
medium to encourage tissue ingrowth, and to discourage excessive
thrombosis. Such coatings and treatments will occur to those
skilled in the art based on the teaching of the present disclosure.
It is further anticipated that research will suggest that these
media may be absorbable or made from non-woven fabrics, or
combinations of both.
[0071] It is therefore shown that the use of a hemostatic medium is
a novel approach to providing a complete minimally invasive
anastomotic device which does not use excessive clamping
forces.
[0072] Although a hemostatic material is shown in the preferred
embodiment as a woven synthetic cuff, those skilled in the art will
be taught by this disclosure to substitute other materials without
departing from the scope of the present invention. The term "cuff"
can be used to describe a form of hemostatic medium but is not
meant to be limiting.
[0073] The means and method places one or more configurations of
hemostatic medium on the outside surface of blood vessels being
joined with the inner edges of the media spaced from the edges of
an incision made in the blood vessel at a distance so no
evagination of the vessel occurs and no gapping occurs during the
healing process. Each cuff is flexible and can be shaped to match
the blood vessel at the junction site. When the cuff or cuffs are
closed, the blood vessels are drawn together in a manner which
places the inside edge of each of the blood vessels adjacent to the
incisions in abutting contact with each other whereby proper
healing can occur without unduly contorting the blood vessels. The
cuff, or cuffs, have a means which permit each cuff to be shaped
and to retain the set shape whereby the cuff accurately matches the
blood vessel shape and the junction can be shaped to establish the
most efficient flow conditions.
[0074] The present invention can be used to provide an oversized
confluence area so the change in size of the blood vessel to
provide oxygenated flow to the heart can be accommodated. This is
done by providing a fastener that allows for an oversized length
junction and the ability to size and shape the junction after the
two vessels are attached to assure a wide cross-sectional opening
between the vessels. Mechanical fasteners or sutures can be used to
mount the cuff on the blood vessels. The procedure can be performed
while permitting virtually uninterrupted blood flow.
[0075] The instrument used to attach the cuffs to the blood vessels
includes a main body which is adapted to accommodate anvils for
both graft vessels and arteries. The device includes a cuff
engaging means for engaging a cuff to attach the cuff to the blood
vessel and to adjust the shape of the cuff to accurately reflect
the shape of the junction. A linkage connects the cuff engaging
means to an operating element so a surgeon can easily operate the
device. One of the anvils is received in a graft vessel and the
other anvil is received in the artery to which the graft vessel is
to be attached. The artery accommodated anvil includes a blood
passage defining portion so blood can continue to flow through the
artery during the procedure. Furthermore, the instrument stabilizes
the vessel from the beating heart. The artery accommodated anvil is
actually larger than the incision in the artery and is "button
holed" into the artery via the incision. Once in place in the
artery the surgeon can pull up on the vessel at the incision
thereby moving the work area in conjunction with the vessel and
isolating the work surface from the beating heart. This makes the
cuff fastening accurate and precise. Also, it assures that the tool
and the vessel are moving together to isolate the beating heart
movement from the tool.
[0076] The device engages the cuff and not the blood vessel so
shaping and movement occurs while applying only minimal and gentle
pressure to the blood vessels. This permits the junction to be
properly and fully customized without mishandling the blood
vessels. The instrument also has guides for forming the fasteners
or staples.
[0077] As can be understood from the foregoing, and as one skilled
in the art will be able to understand from the teaching of the
present disclosure, the means and method of the present invention
can be applied to multiple grafts and to jump grafts thereby making
such techniques possible and cost effective.
[0078] While the means and method embodied in the present invention
is especially suited for beating heart surgery, it may also be
utilized for minimally invasive procedures that use cardioplegia as
well as standard "open chest" procedures due to its novel time
saving and precision features.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0079] FIG. 1 is a schematic showing a heart.
[0080] FIG. 2 illustrates a prior art method of locating an
incision in an artery for performing an anastomosis.
[0081] FIGS. 3, 4, 5A, 5B, and 6-9 illustrate prior art means and
methods of performing an anastomosis.
[0082] FIG. 10 illustrates the principle of the present invention
in which an anastomosis includes a hemostatic medium located in
such a manner that clots will form externally of the blood
vessel.
[0083] FIG. 11 is a side view of a cuff which is included in the
means for performing an anastomosis according to the present
invention.
[0084] FIG. 11A is a sectional view taken along section line A-A of
FIG. 11.
[0085] FIG. 12 is an sectional view of the cuff taken along line
B-B of FIG. 11A.
[0086] FIGS. 13A-13F show alternative forms of a cuff.
[0087] FIG. 14 is an exploded view showing a singe cuff form of the
invention prior to joining a graft and an artery.
[0088] FIG. 15 is a cut away view showing the single cuff form
after the graft has been joined to the artery.
[0089] FIG. 16 is an elevational cross sectional view of the single
cuff form of the invention joining a graft to an artery.
[0090] FIG. 17 is a perspective view of an anastomosis formed using
the single cuff form of the invention in a side-to-side
configuration, those skilled in the art being able to understand
what an end-to-side configuration will look like based on the
teaching of the present disclosure.
[0091] FIG. 18A shows a single cuff form of the invention just
prior to drawing the ends of the two blood vessels together.
[0092] FIG. 18B shows the single cuff form of the invention after
the ends of the blood vessels have been drawn together.
[0093] FIG. 19 is an exploded perspective view of one form of the
invention in which two cuffs are used to join an artery with a
graft.
[0094] FIG. 20 is a perspective view of a section of the joined
artery and graft using two cuffs.
[0095] FIG. 21 is an elevational cross sectional view of the two
cuff form of the invention in situ.
[0096] FIG. 22 is a perspective view of the two cuff form of the
invention in an anastomosis which joins a graft to an artery in an
end-to-side configuration.
[0097] FIG. 23 is a perspective view of the two cuff form of the
invention in an anastomosis which joins a graft to an artery in a
side-to-side configuration, with the graft being tied off by a
suture.
[0098] FIG. 24 is an elevational view of another form of the two
cuff form of the invention showing how the two cuffs are held
together whereby the graft and the artery are pulled together in
healing abutment.
[0099] FIG. 25 is an exploded perspective view of a tool used in
performing the anastomosis according to the present invention.
[0100] FIG. 25A is an exploded perspective view of a tool used in
performing the anastomosis according to the present invention, with
a cuff in place.
[0101] FIG. 26 is a perspective view indicating the tool in use in
placing a cuff on an artery.
[0102] FIG. 27 is an elevational view of a tool in place in an
artery just prior to setting a cuff on the artery.
[0103] FIG. 28 is an elevational view of a tool in place after a
cuff has been set onto an artery and just prior to removing an
anvil of the tool from the artery.
[0104] FIG. 29 is an elevational view of a tool with an anvil in
place in a graft for placement of a single cuff form of the
invention.
[0105] FIG. 30 shows a graft vessel prepared to receive a cuff.
[0106] FIG. 31 shows a tool holding a cuff prior to placing the
cuff on the graft vessel shown in FIG. 30.
[0107] FIG. 32 shows a tool used to cinch a cuff to a graft vessel
that has been located in a cuff.
[0108] FIG. 33 shows a graft vessel located in a cuff prior to
being cinched to that cuff by the tool shown in FIG. 32.
[0109] FIG. 34 shows the tool just prior to setting the means for
attaching the cuff to the graft vessel.
[0110] FIG. 35 shows an alternative form of a tool for applying a
cuff to a graft vessel.
[0111] FIGS. 36A-36D show the steps used in applying a cuff to a
graft vessel using the tool shown in FIG. 35.
[0112] FIG. 37 shows a tool applying the means for holding the cuff
to the vessel in which the means is such that the vessel will not
be damaged.
[0113] FIG. 38 shows a tool used to join two cuffs together.
[0114] FIG. 39 shows the tool used to join two cuffs together
docked to one cuff and prior to joining that cuff to another
cuff.
[0115] FIG. 40 shows the tool docked to one cuff and joining that
cuff to another cuff.
[0116] FIG. 41 is a flow chart for the method of performing an
anastomosis for a single cuff form of the invention with the
vessels being joined in a side-to-side configuration.
[0117] FIG. 42A is a flow chart for the method of performing an
anastomosis for a double cuff form of the invention with the
vessels being joined in a side-to-side configuration.
[0118] FIG. 42B is a flow chart for the method of performing an
anastomosis for a double cuff form of the invention with the
vessels being joined in an end-to-side configuration.
[0119] FIG. 43 shows a single cuff form of the invention which has
omitted the hemostatic medium.
[0120] FIG. 44 shows the continuously varying nature of the
junction angle.
[0121] FIG. 45 shows the double cuff form of the invention which
has omitted the hemostatic medium.
[0122] FIG. 46 shows how the means and method of the present
invention can be applied to a multiple graft technique.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE
INVENTION
[0123] Locating and Performing the Arteriotomy
[0124] By way of orientation, FIGS. 1 and 2 indicate the locating
and performing of an arteriotomy. As is well understood to those
skilled in the art, locating the position of an anastomosis is
extremely important and extremely delicate. The location must be
selected with extreme accuracy and precision. This is especially so
since the blood vessels are often extremely small. This is
indicated in FIGS. 1 and 2 where the location of a restriction is
indicated as R and an arteriotomy is indicated at I in FIG. 2. The
arteriotomy must be made in a proper location with respect to the
restriction R or the surgery will not be as effective as it could
be. Furthermore, an anastomosis must be performed accurately and
effectively to be successful. The present invention discloses and
teaches a means and a method of performing such an anastomosis.
[0125] Prior Art
[0126] Shown in FIG. 3 is an anastomosis involving a artery 10 and
a graft 12 that is performed according to the prior art. That is,
an incision 14 is defined in artery 10 and a corresponding incision
16 is defined in graft 12. Sutures 18 and 20 are set near the ends
(heel and toe) of the incisions. Additional sutures are set as
indicated in FIG. 4 by reference numerals 1-9 and 1'-9'. Sutures
are indicated at 22 and 24. Once the sutures are set, the graft and
the artery are drawn together as indicated in FIGS. 5A and 5B.
[0127] Ideally, the inside edges of the graft and the artery
adjacent to the incisions are placed into abutting contact with
each other to promote proper healing. The inside edge of the graft
vessel is indicated in FIG. 5A at 26 and the inside edge of the
artery is indicated at 26' in that same figure. As can be seen in
FIG. 5B, the ideal situation has inside edge 26 in abutting contact
with inside edge 26' of the artery. However, as discussed above,
this is not always the case. While most surgeons are extremely
skillful and dexterous, hand suturing is susceptible to errors and
imprecision, especially when the graft and/or artery is extremely
small. In the case of a minimally invasive surgery, this precise
placement may be nearly impossible.
[0128] As discussed above, some prior art anastomosis techniques
have used a ring to join two vessels together. This technique is
indicated in FIGS. 6-9 where ring 30 is placed between two
end-to-end vessels in FIG. 6 and rings 30' and 30" are used with
two end-to-side joined vessels in FIG. 7. The rings serve as the
means for holding the joined vessels together. However, the rings
have several drawbacks, including evaginating the vessels,
restricting the vessels so growth due to higher blood flow is
restricted, and stretching the vessel which causes flattening of
the vessel as indicated at portion 32 in FIG. 8. As discussed
above, the use of rings suggests that an anastomosis is being
viewed as a plumbing connection between two conduits. As was also
discussed above, this is simply not the case with actual blood
vessels. As discussed above, if too much clamping is applied to the
vessels, necrosis may occur. Unhealthy tissue may cause scarring
and in fact may fail to heal. This situation is illustrated in FIG.
9.
[0129] Therefore, the present invention is intended to permit the
performance of an anastomosis in a minimally invasive manner yet to
perform the procedure in an accurate manner and in a manner that
promotes proper healing. The most effective healing will occur when
the hemostatic medium is located on the outside of the blood vessel
so any clots will form on the outside of the vessel. This basic
concept is illustrated in FIG. 10 which shows an anastomotic device
AD comprising a hemostatic medium HM having a stent which includes
means FM for fastening the stent to the vessel and which is located
on the outside of one blood vessel B1 which is to be joined to
another blood vessel B2 and for bringing vessel walls, and the
endothelial lining E1, of the one blood vessel into intimate
approximation with other vessel walls, represented by endothelial
lining E2, of the other blood vessel whereby fibrin clot FC is
formed in the proper location to effect a successful procedure.
Still further, excessive clamping is avoided in the present
invention by obviating the need for clamps, such as are commonly
used in prior art techniques.
[0130] Cuff
[0131] There are two forms of the invention, a single cuff form
(see FIGS. 11-18B) and a single cuff form (see FIGS. 19-24). In the
interest of brevity, this mounting element will be referred to as a
cuff. However, no limitation is intended by this shorthand
reference.
[0132] The single cuff form of the invention has the cuff mounted
on the artery and the graft blood vessel with the vessels being
brought into contact with the vessel attaching elements of the cuff
to attach the two vessels together. It is here noted that for the
sake of brevity, the discussion will be directed to blood vessels;
however, those skilled in the art will be able to understand that
the teaching can be applied to vessels of any sort that occur in a
patient. Accordingly, no limitation is intended by the reference to
a "blood" vessel. The double cuff form of the invention has one
cuff attached to the graft and a separate cuff attached to the
artery. These cuffs are then attached to each other to effect the
connection. The single cuff form of the invention has a single cuff
attached to both the graft blood vessel and to the artery, with the
single cuff attaching the two blood vessels together to effect the
connection. The double cuff form of the invention has each cuff
individually mounted on a blood vessel by an instrument, and the
two cuffed vessels brought together with the cuffs then coupled
together.
[0133] Shown in FIGS. 11, 11A and 12 is a single cuff 40 embodying
the present invention. The cuff is applied to a blood vessel and
will couple that vessel to another vessel or to another cuff. The
cuff can be applied to a blood vessel by an instrument while blood
still flows through the vessel by using a stabilizing cuff
application tool with a flow-through anvil. This enables
anastomotic surgery to be performed without stopping the heart so
the procedure can be carried out in a minimally invasive manner.
The cuff also permits proper shaping of the junction without
mishandling the blood vessels and places the two vessels in an
orientation that promotes efficient healing.
[0134] Specifically, cuff 40 includes an oval shaped flexible body
42 having a long axis 44 and a short axis 46 with an oval shaped
opening 48 defined therein by the cuff body central section 49. The
preferred form of body 42 is a woven fabric suitable for use in
surgery. A stiffening framework 50 of a retention means, such as a
malleable material, is integrated into body 42 for retaining the
cuff in a selected shape on a blood vessel. The preferred form of
the retention means is sinuous and includes a plurality of
malleable sections, such as section 52. In the present context,
this element will be referred to as a retention means. However, as
will occur to those skilled in the art based on the teaching of the
present disclosure, depending on the context of the discussion,
this element can also be referred to as a "stent" or a "stiffening
band." One form of the material is a wire that is suitable for use
in the surgical environment associated with this invention. The
retention means has little material memory in that once deformed
from one shape into another, it will not move back into the first
shape from the second. A second potential form for the retainer
means is shaped from flat stock which is processed using precise
methods such as wire EDM or photo etching. Shaping the cuff is
therefore efficiently carried out by deforming it into the desired
shape after it is mounted on a blood vessel. The retention means
will maintain the cuff in the shaped condition. Sections of the
stiffening framework may be separate from other sections, such as
quartered sections or the like.
[0135] Each malleable section has an apex, such as apex 54, with a
cuff retaining pin, such as pin 56, thereon. Cuff retaining pins 56
attach the stiffening framework 50 to the cuff, and anchor means 58
attach base 60 of each section 52 to body 42 to securely anchor the
stiffening framework to body 42. However, many cuff pins may be
used to secure the cuff frame to the cuff.
[0136] Tissue retention pins 62 are attached at a proximal end 64
thereof to the body 42 and have a distal end 66 which engages a
blood vessel to anchor the cuff to that blood vessel in the manner
of a surgical staple. The instrument discussed below is used to
force the retention pin into the blood vessel tissue to anchor the
cuff to the blood vessel.
[0137] Means for shaping the cuff once it is anchored on the blood
vessel includes docking extensions, such as docking extensions 70,
having a proximal end 72 unitary with a base of a malleable section
of the stiffening framework and a distal end 74 spaced from the
outer perimeter 76 of the cuff body 42. An eyelet 78 is located on
distal end 74 having a central hole 80 defined therein to engage a
corresponding element on the instrument used to place the cuff. The
means for shaping the cuff also includes a plurality of second
docking extensions 82 having proximal ends 84 integral with
alternate apexes of the stiffening framework 50 and a distal end 86
having an eyelet 88 with a central hole 90 for releasable
connection to a corresponding element on the instrument used to
place the cuff.
[0138] As will be discussed below, the docking extensions are
engaged with the instrument, and once the cuff is anchored to a
blood vessel, the instrument can be manipulated by the surgeon to
shape opening 48 to the desired size and shape. Once the desired
size and shape have been established, the cuff and framework is
released from the instrument.
[0139] As can be seen in FIG. 11, the cuff has an hour glass shape
in elevation, with body 42 having a first end section 92 and a
second end section 94 of roughly the same outer dimension, with
central section 49 having an outer dimension of less than those
outer dimensions to define a waist section. Other forms of the
single cuff are illustrated in FIGS. 13A-13F.
[0140] Use of the single cuff form of the invention is illustrated
in FIGS. 14-18B. The tool for effecting the placement of the cuff
and the coupling of the two vessels will be discussed below in
connection with FIGS. 25 et seq. For present purposes, the results
will be shown and discussed. As shown in FIG. 14, after the graft
vessel G and the artery A have been prepared, the cuff is placed on
the artery A. The graft vessel is then moved into proximity of the
cuff as shown in FIG. 14 and joined to the cuff as shown in FIGS.
15 and 16.
[0141] As can be seen by comparing FIGS. 18A and 18B, once the
cuffs are attached to the blood vessels, the blood vessels are
brought together to form the desired connection, and then are
shaped so the desired amount of abutting contact is formed between
the two adjacent inside blood vessel edges. To effect the desired
amount of abutting contact between the inside edges of the blood
vessels, the single cuff form of the invention can include a means,
such as bridge means 110 shown in FIGS. 18A and 18B to draw the
adjacent blood vessel inside edges 26 and 26' together into
abutting contact from the spaced positioning of these two edges
shown in FIG. 18A to the abutting contact shown in FIG. 18B. Bridge
means 110 includes a malleable wire 112 or extensions 70, 82, etc.
that has essentially no material memory similar to that situation
discussed above with regard to the stiffening framework 50. Thus,
when bridge wire 112 is deformed from the FIG. 18A configuration to
the FIG. 18B configuration, it will retain the FIG. 18B
configuration thereby placing the inside edges 26 and 26' in
abutting contact with each other. Deformation of wire 112 can be
effected with a proper tool. The bridge can also be formed from
shaping pins resistance welded together.
[0142] It can also be understood from this disclosure that as the
edges of the vessels are brought into intimate contact, there is a
defined junction angle noted by JA in FIG. 18B. This angle varies
continuously with respect to a linear reference, such as the
longitudinal centerline of the vessels at the junction, as a unit
vector associated with the angle follows around the periphery at
the anastomotic junction. The means and method of the present
invention permits this variation in angle. This variation in
junction angle effects a properly shaped anastomosis for
dissimilarly sized vessels. This angle will also vary at the heel
and the toe depending on the appropriate angle of the graft vessel,
as shown in FIG. 44 at JA', JA" respectively.
[0143] By way of reference, a single cuff side-to-side anastomosis
is shown in FIG. 17.
[0144] The double cuff form of the invention is illustrated in
FIGS. 19-24. As can be seen (see, e.g., FIG. 21), one cuff 40' is
attached to a graft blood vessel G, and a second cuff 40" is
attached to the artery A. As can be seen in FIG. 19, there is a
spacing between the fastening means attaching the cuff to the
vessel and the edge of the artery. This spacing is selected so the
loose edge of the vessel can still be controlled, but the fastening
means is not located too close to the edge of the vessel. Bringing
the cuffs together in this manner does not mishandle the blood
vessels and promotes efficient healing of the junction. A spacing
of 1/2 mm to 1 mm is shown in FIG. 19. However, this spacing is
disclosed for the sake of completeness and is not to be taken as
limiting.
[0145] Means for joining one cuff to the other in the double cuff
form of the invention includes one unit 98 fixed to the graft
(cuff) blood vessel G and one unit 99 fixed to the artery (cuff) A.
As shown in FIG. 19, a female element 100 is fixed to cuff 40' and
a corresponding male element 102 is fixed to cuff 40". Female
element 100 includes an eyelet 104 that has an opening sized and
shaped to snugly receive male element 106 mounted on element 102 to
establish a friction fit between elements 100 and 102 that securely
couples the two cuffs together. The preferred form of the cuff
joining means includes four male elements and four female elements
on each base 98 and 99, each being located on opposite sides of the
cuffs as is shown in FIGS. 22 and 23. Each cuff has two male
elements and two female elements with the male elements on each
base whereby a secure attachment is effected.
[0146] As can be understood by those skilled in the art by
comparing FIGS. 21 and 16, the double cuff form of the invention
uses two cuffs, such as 40' and 40", to attach two blood vessels
together, whereas, the single cuff form of the invention uses a
single cuff 40'" to attach two blood vessels together. The double
cuff form of the invention has two similar cuffs attached together
by a coupling means. The single cuff form of the invention has a
single cuff with the two ends thereof identical each having a
stiffening framework therein and each having tissue retention pins
62'" therein. A single body unitary 42'" forms the cuff 40'".
[0147] Both forms of the invention, the single cuff and the double
cuff, can be used to form both a side-to-side anastomosis and the
double cuff form can be used to form an end-to-side
anastomosis.
[0148] The double cuff form of the invention is applied as
indicated in FIGS. 19-23. A tool, which will be discussed below in
connection with FIGS. 24 et seq, is used to place a cuff on the
graft, and then a second cuff on the artery. The vessels are then
oriented adjacent to each other as indicated in FIG. 19, and then
brought together so the two cuffs are coupled as indicated in FIG.
20. The cuffs are then coupled together as indicated in FIG. 21 to
form an end-to-side anastomosis as indicated in FIG. 22 or to form
a side-to-side anastomosis as shown in FIG. 23. The two cuffs are
coupled together by a suitable fastener, such as the
above-discussed male/female coupling shown in FIG. 21.
[0149] An alternative form of the cuff joining means for the double
cuff form of the invention is shown in FIG. 24. This form of the
cuff joining means includes rivets or staples 114 in place of the
male and female elements discussed abov. The rivets or staples are
placed in bases 98 and 99 and hold the bases together in the manner
discussed above for the male and female elements 104 and 106.
[0150] Instrument
[0151] As discussed above, the anastomosis technique of the present
invention is intended to be performed in a minimally invasive
manner. Therefore, the cuffs discussed above must be placed on
blood vessels that are located inside a patient, with the artery
carrying blood. As was also discussed above, the anastomosis
technique of the present invention may involve extremely small
blood vessels. Accordingly, the instrument used to effect the
anastomosis must be very accurate and precise, yet will not
mishandle the blood vessels during performance of the technique.
The instrument will place a cuff on the artery while permitting
blood to flow through that artery, and then will place a
corresponding cuff on the graft blood vessel, or will attach the
graft blood vessel to the single cuff mounted on the artery in the
single cuff form of the invention. The instrument will then be used
to shape the cuffs so the junction is the most efficient and will
permit proper healing. All of this must be carried out in a
minimally invasive manner.
[0152] The preferred form of the instrument used to mount a cuff to
the artery in both forms of the invention and to mount the cuff to
the artery and to the graft in the double cuff form of the
invention is shown in FIGS. 25-29, with FIG. 25A showing a cuff in
conjunction with the instrument. Instrument 120 broadly comprises a
handle frame 122 having a handle 124 that is grasped by a surgeon
during operation of the instrument, and a finger frame 126 having a
finger grip 128 which is operated by the surgeon, two driver
elements 130 and 132 pivotally attached to the handle frame, a
graft anvil 134 and an artery anvil 136.
[0153] More specifically, in FIG. 22, handle frame 122 includes a
U-shaped section having legs 140 and 142 attached at one end to
handle 124 and which are spaced apart to define a channel 144
therebetween. Each leg has an inside surface 146 with L-shaped
anvil alignment slots 148 and 150 defined in the legs to have short
legs 152 that intersect the channel and long legs 154 defined to be
parallel to the channel. The function of the anvil slots will be
understood from the following discussion.
[0154] The handle frame further includes two ears 156 and 158. The
ears include two spaced apart plates 160 and 162 with bores 164 and
166 defined in each plate to be centrally aligned with each other
for a purpose that will be understood from the following
discussion. The handle frame further includes two rails, such as
rail 170, on the outer edges of the legs 140 and 142.
[0155] An undercut region 174 is defined in the proximal end of the
handle frame with a top shoulder 176 defined therein at the top
entrance to channel 144. Shoulder 176 is U-shaped and has a channel
178 defined between leg 180 corresponding to leg 140 and leg 182
corresponding to leg 142.
[0156] Finger frame 122 includes a U-shaped base 184 having two
legs 186 each connected to a center section 190 and defining a
channel 192 therebetween. A slot 194 is formed at the intersection
of each leg and the center section, with slots 194 being sized and
located to slidably receive rails 170. Sliding engagement between
the rails and the slots permits the finger frame to move with
respect to the handle frame longitudinally of the channel 190 as is
indicated by the double-headed arrow 196, with handle frame 122
moving in direction 198 with respect to finger frame 126 to open
the instrument anvils and moving in direction 200 with respect to
the finger frame to close the instrument anvils as will be
discussed below.
[0157] Each leg 186 of the finger frame 126 further includes an
ear, such as ear 202 on a distal end thereof to which a guide pin,
such as guide pin 204, is fixed to extend past the handle frame leg
adjacent thereto.
[0158] Instrument 120 further includes two pivot pins 206 and 208
accommodated in the aligned bores 164 and 166. Each of the driver
arms 130 and 132 has a pivot pin receiving hole 210 and 212
respectively defined in the proximal end of arms 214 and 216
respectively. A crescent-shaped driver element 218 and 220 is
located on the distal end of each arm 214 and 216 respectively with
a cam slot 222 and 226 being defined in the arms 214 and 216
respectively.
[0159] The arms are pivotally attached to the handle frame by the
pins 206 and 208 to move in directions 226 and 228 as indicated by
double-headed arrow 230 when finger handle 126 moves directions 198
and 200 respectively to open and clos the driver heads 218 and 220.
Slots 222 and 226 slidably receive guide pins 204 to effect this
opening and closing movement. Since the driver arms are fixed at an
angle to handle frame 122 by pivot pins 206 and 208 and guide pins
204 move longitudinally with respect to the handle frame and
slidably engage cam slots 222 and 226, longitudinal movement of the
finger frame with respect to the handle frame will cause the
above-mentioned pivotal movement of the anvil arms. The opening and
closing of the driver arms is illustrated in FIGS. 27 (closing) and
28 (opening).
[0160] Each driver head, 218, 220 has a V-shaped cuff-engaging
edge, such as edge 232 which is sized and shaped to engage the
waist section 49 of a cuff. Each edge 232 also has two surfaces 234
that diverge away from each other from the edge 232 to engage
surfaces 236 and 238 (see FIG. 12) respectively of the cuff
sections 92 and 94. Engagement of the surfaces 234 and 236, 238
along with a movement of the anvils 136 and 139 forces the tissue
fasteners 62 into the tissue of the blood vessel while shaping the
cuff to the blood vessel.
[0161] The tissue fasteners must be turned in the manner of a
staple in order to fully connect a cuff to a blood vessel.
Accordingly, instrument 120 includes artery anvil 136 and graft
anvil 134 which are removably fixable to the handle frame. Graft
anvil 134 includes a body 240 having a threaded portion 242 on a
proximal end thereof, a graft anvil head 244 on a distal end
thereof and alignment pins 246 between the two ends thereof. A
fastening knob 247 is also included with instrument 120, and is
internally threaded to threadably engage threaded portion 242.
[0162] Knob 247 is accommodated in undercut area 174 and threaded
portion 242 is extends through channel 178 to be engaged by the
threaded portion of the fastener 247. Longitudinal movement of the
graft anvil in directions 260 and 262 is effected by threading the
knob 247 on the threaded portion 242. Threaded movement in one
direction moves the graft anvil in direction 262 and threaded
movement in the opposite direction moves the graft anvil in
direction 260 whereby the location of the graft anvil head 244 with
respect to the driver elements 218, 220 can be adjusted and set.
The purpose of this movement will be understood from the discussion
in this disclosure.
[0163] A groove in knob 247 engages lip 176 of handle 120. Since
knob 247 remains stationary the anvil moves up or down to bend or
cinch the fasteners 62. Body 240 includes a first portion 248 and a
second portion 250 that is angled with respect to the first portion
248. Graft anvil head 244 has a proximal end thereof fixed to
portion 250 to extend transverse to longitudinal centerline 252 of
the body 240. The length of body 240 as measured between its
proximal and distal ends is greater than the length of the handle
frame as measured along its longitudinal centerline 252 between the
shoulder 176 and distal end 256 whereby graft anvil head 244 is
spaced from distal end 256 when the graft anvil 134 is mounted on
the handle frame. Arm 248 is also long enough so that graft anvil
head 244 is also spaced from driver heads 218 and 220 when the
graft anvil is in place on the handle frame. Alignment pins 246 are
received through anvil slots 148 and 150 and are slidably
accommodated in slots 154 so the graft anvil is securely and
movably affixed to the handle frame.
[0164] Artery anvil 136 includes a body 270 having a threaded
portion 272 on a proximal end thereof and an artery anvil head 274
on a distal end thereof. Alignment pins 276 are located on the body
to be received through alignment slots 152 and slidably
accommodated in slots 154 on the handle frame. When the artery
anvil is attached to the handle frame, threaded portion 272 extends
through channel 178 and is threadably received by knob 247 to
attach the artery anvil to the handle frame and to move that artery
anvil in directions 260 and 262 with respect to the handle frame as
was discussed above with regard to the graft anvil whereby the
location of the artery anvil head 274 with respect to the driver
heads 218, 220 can be set. The artery anvil head 274 is located
beneath the driver heads so that the head can be inserted into an
artery and a cuff being supported by the driver heads will be
located outside that artery. Once the artery anvil head is
positioned inside an artery, the knob 247 is operated to move the
anvil head 274 toward the driver heads 218, 220 until the cuff
supported in the heads 218, 220 engage the outside of the artery.
The tissue retention pins can then be set.
[0165] Artery anvil head 274 includes a bullet shaped body 280
having two ends 282 and 284 with a bypass channel 286 defined
longitudinally therethrough from one end 282 to the other end 284.
This channel permits blood flow through the anvil head maintaining
perfusion while the cuff is being attached. A fastener turning
section 288 is defined in top surface 290 of the head 274 adjacent
to the intersection of the head and the body 270 and in a location
to receive ends 66 of the tissue fastening pins when they are
forced through the blood vessel wall. The fastener turning section
is concave so the pin is turned as it engages and follows the anvil
head surface adjacent to the turning section. This rotates the
fastener end so the fastener is gradually bent from the FIG. 7A
shape to a curved shape shown in FIG. 25, for example. The tissue
fastener is forced to follow this turning section by engagement of
the driver head surface against the cuff and against the fastener
body 62 as the heads 218, 220 are moved into engagement with the
cuff by operation of the finger frame 122 and as the artery anvil
is moved in direction 260 by operation of the knob 247 on threaded
portion 272.
[0166] Driver heads 218, 220 include docking pins 294 which
releasably engage holes 80 and 90 of the docking pins 70 and 82 on
the cuff to control the shape of the cuff. The friction fit between
pins 294 and the pins. 70 and 82 is great enough to permit the cuff
to be pulled and shaped by movement of the driver heads, but low
enough so the pins 294 can be pulled out of the docking elements
without pulling the cuff off of the blood vessel. Alternatively,
pins 294 could be retracted through a flexible shaft connected up
to the handle. Pulling the driver heads outwardly in direction 226
will enlarge the junction and will change its shape from oblong
toward circular. Therefore, a surgeon can shape the junction in the
manner that is most efficient to healing and to defining an
effective anastomosis.
[0167] An assembled instrument is shown in FIG. 26 with an artery
anvil being inserted through an incision I in an artery A and a
cuff 40 on the driver elements. As can be seen, once the incision
is made, the artery anvil head is button holed into the artery via
the incision. The anvil head is actually larger than the incision
in the artery but can be angled through the incision into position
as shown in FIG. 26. The knob 247 is operated to draw the anvil
head and vessel surface at the incision up toward heads 218, 220.
This action also isolates the working area from motion associated
with the beating heart. As indicated in FIG. 27, after the head
supported cuff contacts the outside of the artery, driver heads
218, 220 are operated to force the edges 232 against the waist 49
and against the surfaces 236 and 238, and the knob 247 is further
operated to draw the anvil and the cuff together. Further operation
of the knob 247 forces the tissue fasteners through the blood
vessel tissue, into turning section 288 and around on themselves in
the manner of a staple whereby the cuff is fixed to the blood
vessel. During this operation, blood flows through the artery via
channel 286. Once the cuff is attached to the artery, the driving
heads 218, 220 are opened as shown in FIG. 28 so the anvil head 280
can be removed from the artery. Since the cuff is connected to the
driver heads, opening the driver heads will enlarge the incision
thereby permitting the artery anvil to be removed.
[0168] The graft vessel is prepared in a similar manner. The graft
anvil is inserted into the graft blood vessel via the end of that
blood vessel and is tied to the graft anvil head 244 with a
garroting suture. The graft anvil 134 is attached to handle frame
122. The instrument is operated to attach a cuff to the graft blood
vessel in a manner similar to that just described for attaching a
cuff to the artery. Actually, the graft is prepared first because
the surgeon has more time to work on the graft than on the artery.
The graft anvil allows the surgeon to prepare the graft on the
anvil first and then attach the anvil to the instrument at a later
time when it is convenient to do so.
[0169] The instrument is then maneuvered so the graft blood vessel
is adjacent to the cuff mounted on the artery. The knob 247 is then
operated to force the graft blood vessel into contact with the cuff
portion that is not attached to the artery to attach the graft
vessel to the artery attached cuff. As shown in FIG. 29, the graft
anvil head has a fastener turning section 296 which operates to
turn the fasteners in that section of the cuff in a manner
identical to the above-described turning of the fasteners in the
artery. This is illustrated in FIG. 29 for a single cuff
embodiment. Turning section 296 is used to turn the tissue
retention pins to either attach a single cuff to the blood vessel
or to attach a separate cuff to the blood vessel. Once the cuff is
attached to the graft (for the single cuff embodiment), or the cuff
on the graft is attached to the cuff on the artery (for the double
cuff embodiment) by attaching the coupling elements 106 and 104
(for the double cuff form) or the bridges 110 are manipulated to
bring the inside edges 26 and 26' of the vessels together, the
driver heads 218, 220 are manipulated to enlarge the graft incision
to permit the graft anvil head to be withdrawn from the graft
vessel via the end of that vessel. The driver heads can then be
further manipulated to size and shape the junction, and then
manipulated to remove the docking pins 70 and 82 from the anvil
pins 294 to release the cuff or cuffs from the instrument. The
garrot suture is cut and the graft anvil is removed from the graft.
The graft blood vessel is then tied off and the anastomosis is
complete.
[0170] Instrument for Mounting a Cuff on the Graft Artery
[0171] Shown in FIGS. 30-34 is one form of an instrument used to
mount a cuff on a graft artery. An alternative form of the
instrument is shown in FIGS. 35-37.
[0172] As shown in FIG. 30, a graft G is prepared by defining an
incision IG therein. The graft has been removed and is being
prepared and cuffed outside of the patient. An instrument 300 is
shown in FIG. 31 and includes tongs 302 and 304 having
cuff-engaging ends 302' and 304' respectively, and handles 302" and
304" respectively which are gripped by the surgeon. A pivot 306 is
located at the intersection of the tongs. Each of the tongs has a
cutout portion which conforms to one-half of the shape of a cuff
whereby a cuff will be securely held in the tongs as indicated in
FIG. 31. Elements 106'" are located on the tongs to engage the
female elements on the cuff to hold the cuff in position on the
tongs. As can also be seen, each tong has a cutout section 310 for
engaging anvil 312 shown in FIG. 32.
[0173] Anvil 312 includes a central section 314 having an opening
defined in a top section 316 thereof. A section 318 includes two
side sections 324 and 322, each of which has a cutout, such as
cutout 326 in side 322, defined therein. Anvil 312 further includes
a threaded element 328 extending through the opening defined
through top section 316 and is pivotally attached to section 318 at
329. Threaded element 328 is threadably received through a threaded
opening 326' defined through section 336. A knob 330 is unitary
with the threaded element 328. Rotation of the knob moves top
section 318 relative to arms 334 as indicated by double-headed
arrow 332. Arms, such as arm 334 have top section 336 engaging the
threaded element 328. Movement of the threaded element causes the
hook sections 338 to move into and out of the cutouts.
[0174] As shown in FIG. 33, graft G is drawn upwardly through the
cuff mounted on instrument 300 to located edge GE above the cuff,
and above the fasteners 66 of the cuff. Then, as indicated by arrow
340, anvil 312 is moved to orient hooks 338 in cutouts 310. This
condition is shown in FIG. 34.
[0175] Side sections 322 and 324 are unitary, and each includes a
fastener turning area 343 and 345 located to engage fastener 66
when the anvil is operated.
[0176] After the anvil is engaged with the instrument 300, movement
of the threaded element forces elements 322 and 324 downwardly
until turning areas 343 and 345 engage the ends of fasteners 66.
Further movement of the elements 322, 324, turns fasteners around
to attach the cuff to the graft vessel in the manner of a staple.
Once the cuff is secured to the vessel, the anvil is released, and
the cuff and attached vessel removed from the instrument 300. As
will be understood from the above discussion, the fasteners 66 are
evenly turned by the anvil to evenly mount the cuff to the graft.
The cuffed graft can then be laid aside until it is needed.
[0177] An alternative form of an instrument used to mount a cuff on
a graft is shown in FIGS. 35-37. The graft is prepared in the
manner discussed above.
[0178] End cuff attaching tool 350 includes a housing 352 having a
forming cavity 354 defined therein to extend from end wall 356
adjacent to edge forming elements 358 and 360. Housing 352 is
slidably mounted on plate 362 by a track 363 to be moved by hand
pressure in directions 363' and 363". Housing 364 is mounted on
plate 362 and slidably receives a pushrod 366. Pushrod 366 has a
link 368 attached at one end thereof by a pivot pin 370. Pushrod
366 can be operated by hand to move in directions 372 and 374 as
indicated by double-headed arrow 376.
[0179] A tilt table 380 is pivotally attached to the plate 362 by
pivot pins, such as pin 382, and is pivotally attached to the link
368 by pin 384. As can be seen in FIG. 35, movement of the pushrod
in direction 374 tilts the table in direction 386 about pin 382,
and vice versa for pushrod movement in direction 372. The table
moves from the position shown in FIG. 35A to the position shown in
FIG. 35C under the influence of this pushrod movement.
[0180] A vessel receiving element 390 is mounted on one end of the
plate 362 to extend upwardly and outwardly therefrom at an angle as
shown in FIG. 35. Table 380 includes a cutout section 392 which
receives a cuff with cuff toe 394 on top and cuff heel 396 on the
bottom. Table 380 includes alignment pins 398 that are received in
alignment holes 400 on the cuff, and alignment holes 402 that
receive alignment pins 404 on the cuff to releasably secure the
cuff to the table.
[0181] As can be seen in FIG. 35, shaft 390 will extend through the
cuff-receiving section 392 and through the cuff mounted on the
table. Graft G is placed over the shaft to extend through the cuff
with end 406 attached to hooks 408 on the table to temporarily
mount the graft to the instrument plate 362. Operation of the
pushrod tilts the table in direction 386 to bring the cuff down on
top of the graft as can be understood from FIGS. 36A, 36B and 36C.
Once the cuff is in place as shown in FIG. 36C, the housing 352 is
moved toward the end of the table in direction 363" as shown in
FIGS. 36C and 36D. The cuff and graft are guided into cavity 354
and the front end of the cuff and graft engage the end of the
cavity as indicated in FIGS. 36D and 37. The shaft 390 includes
fastener turning areas, such as area 410 and the turning movement
of the table forces cuff fasteners through the graft and into
engagement with the shaft at the turning areas. Further turning
movement of the table turns the fasteners to couple the cuff to the
graft. Movement of the housing 352 in direction 363" engages
J-shaped fastener 66' with the housing and forces that fastener
through the graft and into turning area 410. Further movement of
the housing turns the fastener to couple the cuff to the graft.
Once the J-shaped fasteners are coupled to the graft, the cuff is
coupled to the graft and the housing can be moved in direction 363'
and, table 380 moved opposite to direction 386. The cuffed-graft
can then be removed from the shaft 390. The J-shape of fasteners
66' prevents the graft vessel from becoming damaged from otherwise
protruding pins from the cuff as the tilt-table is being rotated.
The variation in shape of the fasteners thus protects the graft
vessel.
[0182] As before, once the graft vessel is cuffed, it can be set
aside until the artery is cuffed.
[0183] Instrument for Coupling One Cuff to Another
[0184] Shown in FIGS. 38-40 is an instrument that can be used to
couple one cuff to another in the double-cuff form of the
invention. As shown in FIG. 38, instrument 450 is releasably
attached to a vessel-mounted cuff, and is then operated to attach
that cuff to another vessel-mounted cuff. One cuff can be attached
to an artery using the instrument shown in FIG. 25 (using elements
130, 132 and 136) while a cuff can be attached to a graft using the
instrument shown in either FIG. 31 or FIG. 35 in an end-to-side
anastomosis, or using the instrument shown in FIG. 25 twice (using
elements 130, 132 and 136 to attach a cuff to an artery and using
element 134 to attach a cuff to a graft) in a side-to-side
anastomosis.
[0185] The two cuffs are attached together using instrument 450
shown in FIG. 38. Instrument 450 includes a handle 452 having a
hand-grip 454 on one end thereof. A trigger housing 456 is mounted
adjacent to the hand grip. An anchor element 458 is also mounted on
the handle adjacent to the hand grip. A cuff engaging section 460
is mounted on the other end of the handle and includes a base 462
having a forward end 464 and an aft end 466. Cuff engaging C-shaped
hooks 468 are pivotally mounted on the base section by pivot bars,
such as bar 470 extending through the hooks so the hooks pivot in
directions 472 and 474. Clamping hooks 476 and 478 are also
pivotally mounted on the base section by bars 470 to move in the
directions 472 and 474. Hooks 468 are spring biased in direction
474 by springs, such as spring 480 and hooks 476 and 478 are fixed
to bar 470 for rotation therewith. Hooks 476 include cutout
portions, such as portion 482. It is noted that a hook 478 is not
shown in FIG. 38 but is located on the base diametrically opposite
to hook 478. Hooks 468 clamp instrument 450 to the cuff, and hooks
476 and 478 force the male fastening elements such as element 106
of one cuff through female elements, such as element 104, of the
other cuff. For this reason, hooks 476 include a cutout section to
accommodate the male element, whereas hooks 478 do not include a
cutout section as these hooks engage the female elements.
[0186] The hooks are operated by hand. As shown in FIG. 38, hooks
468 are operated by mechanism 490 which includes a tether 492
attached at one end thereof to element 458 and at the other end
thereof ears 494 on each hook 468. Tether 492 extends through guide
496 which is located between the ears 494. Therefore, movement of
element 458 in direction 498 draws ears 494 together in directions
500' and 500" against the bias of springs 480. The springs tend to
move the hooks into cuff engaging positions, such as shown in FIG.
39, and the tether is operated to release tool 450 from the cuff.
The tool 450 is shown attached to a vessel mounted cuff in FIG.
39.
[0187] Hooks 476 and 478 are operated by a system 504 which
includes a tether 506 attached at one end thereof to the trigger
housing 456 and at the other end thereof to levers 506. The tether
extends through guides 508. Levers 506 are pivotally mounted on the
base section by pins 510 to move in direction 512 when the trigger
housing is moved in direction 514. The pivot pins 510 are fixed to
rod 470 to rotate that rod in direction 512 with the levers. Hooks
476 and 478 are fixed to the rod 470 for rotation therewith, and
rotation of the levers in direction 512 rotates the rod 470 in
direction 516. Rotation of the hooks 476 and 478 in direction 516
moves those hooks from the FIG. 38 position to the cuff engaging
position shown in FIG. 40. Rod 470 is also spring biased by a
torsion spring, so when the trigger housing is released, that rod
will rotate to release hooks 476 and 478 back into the FIG. 38
position.
[0188] After the tool is mounted to a cuff, that cuff is attached
to the other cuff. The cuff and tool are moved adjacent to the
other cuff, as shown in FIG. 39, and the two cuffs are brought
together and coupled as above described.
[0189] Method
[0190] FIGS. 41, 42A and 42B represent the method of using the
above-described instrument in performing an anastomosis according
to the teaching of the present invention.
[0191] The following steps are used to effect the anastomosis of
the present invention in the single cuff method.
[0192] The location of the anastomosis is determined.
[0193] The graft is pulled onto the graft anvil.
[0194] The graft is garroted to the graft anvil.
[0195] The graft and graft anvil are set aside.
[0196] Perform arteriotomy.
[0197] Button-hole artery anvil into interior lumen of the
artery.
[0198] Dock the artery anvil to the instrument.
[0199] Cinch the fasteners joining the cuff to the artery.
[0200] Operate the instrument to open the arteriotomy to full
length.
[0201] Open the driver heads and bend shape the cuff.
[0202] Detach the artery anvil from the instrument and remove the
artery anvil from the artery.
[0203] Close the drivers to accept the graft anvil.
[0204] Dock the graft anvil to the instrument.
[0205] Cinch the fasteners joining the cuff to the graft (single
cuff form), or the cuff on the graft to the cuff on the artery
(double cuff embodiment).
[0206] Release the graft garret.
[0207] Release the graft anvil from the instrument and tie off the
graft end.
[0208] Open the shape of the anastomosis with the instrument.
[0209] Release the instrument from the cuff or cuffs.
[0210] The double cuff technique is shown in FIG. 42A for a
side-to-side anastomosis and in FIG. 42B for an end-to-side
anastomosis.
[0211] It should also be understood that while the hemostatic
medium is shown in the preferred embodiments, there may be certain
uses, such as mentioned above, of the device that will not require
the hemostatic medium. The joining at lumens like fallopian tubes
is one example. It is therefore contemplated that this disclosure
will cover an anastomosis means and method which omits the
hemostatic medium. One example of this hemostatic medium-less
anastomosis is shown in FIG. 43 in which the tissue pins are
staggered in a manner that allows the approximation of the tissue
in a sinuous junction line. This will mimic the type of
approximation that sutures provide by interweaving from one side to
the other. The sinuous junction SJ is shown in FIG. 43 as tissue
pins attached to an external malleable stent S. Tissue is shown as
T.
[0212] It is further possible at that point to join the two stents
with materials that are flexible but which still hold the edges in
approximation creating a living hinge between the two stents. The
junction SJ will thus be a living hinge about which the two vessels
can pivot or move. FIG. 43 shows a single cuff design with only one
bridge being shown for the sake of clarity of disclosure, it being
understood that other bridges, as discussed above, are also
included in the FIG. 43 embodiment. A double cuff design is shown
in FIG. 45, with only one coupling element being shown.
[0213] Although this invention has been disclosed and illustrated
to show the anastomosis of small distal grafts, there are other
surgical procedures that will benefit from this type of improvement
as will occur to those skilled in the art based on the teaching of
this disclosure. For example, a proximal graft attachment to aortic
supply, an anastomosis of other luminal structures such as, but not
limited to, Fallopian tubes urethra, ureter, bile ducts, etc. can
also be performed using the means and method disclosed herein.
[0214] FIG. 46 shows the use of the present means and method as
applied to multiple grafts. As above discussed, where an existing
blood supply conduit, such as the IMA, is not available to use, an
artificial supply vessel must be grafted. Usually another vessel
such as the saphenous vein is harvested from the patient's leg. At
this point, the graft must be attached to a supply. This is usually
the aorta AA. In the area above the aortic valve, a proximal
anastomosis P is performed using the techniques discussed above to
attach the new supply conduit to the aorta. The means and method
discussed above is used to perform this procedure. The means and
method discussed above is also used to attach the jump graft JG in
an end-to-side manner ES in addition to the side-to-side manner SS
shown. Multiple grafts are thus effected using the teaching of the
present invention. As will be understood by those skilled in the
art based on the teaching of the present disclosure, any vessel
that needs to be by-passed or joined use the techniques of this
invention.
[0215] In addition, it is understood that while the invention is
particularly well suited for endoscopic use, it is in no-way
limited to such application. This invention will work equally well
in an "open" surgical setting. Accordingly, these situations are
intended to be included in the scope of the present invention.
[0216] It is understood that while certain forms of the present
invention have been illustrated and described herein, it is not to
be limited to the specific forms or arrangements of parts described
and shown.
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