U.S. patent application number 12/182836 was filed with the patent office on 2008-11-20 for device and methods for suturing tissue.
This patent application is currently assigned to Abbott Laboratories. Invention is credited to Bernard H. Andreas, Michael Barrett, Mark J. Foley, Brian gore, Lewis Isbell, Ronald Songer, James W. Vetter.
Application Number | 20080287967 12/182836 |
Document ID | / |
Family ID | 25535275 |
Filed Date | 2008-11-20 |
United States Patent
Application |
20080287967 |
Kind Code |
A1 |
Andreas; Bernard H. ; et
al. |
November 20, 2008 |
Device and Methods for Suturing Tissue
Abstract
Systems for suturing a tissue layer having two sides with a
suture be releasably retaining at least a portion of the suture in
a stationary position on one side of the tissue layer. The portion
of the suture is retrieved through the tissue layer from the
opposite side whereby the suture is drawn from one side to the
opposite side. Systems for suturing the wall of a tubular graft
having two sides is also provided using a suture by releasably
retaining at least a portion of the suture on one side of the wall.
the portion of the length of suture is retrieved through the wall
of the graft to the opposite side of the wall.
Inventors: |
Andreas; Bernard H.;
(Redwood City, CA) ; Barrett; Michael; (Campbell,
CA) ; Foley; Mark J.; (Menlo Park, CA) ; gore;
Brian; (Naperville, CA) ; Isbell; Lewis;
(Santa Clara, CA) ; Songer; Ronald; (Palo Alto,
CA) ; Vetter; James W.; (Portola Valley, CA) |
Correspondence
Address: |
WORKMAN NYDEGGER
1000 EAGLE GATE TOWER,, 60 EAST SOUTH TEMPLE
SALT LAKE CITY
UT
84111
US
|
Assignee: |
Abbott Laboratories
Abbott Park
IL
|
Family ID: |
25535275 |
Appl. No.: |
12/182836 |
Filed: |
July 30, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10737668 |
Dec 16, 2003 |
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12182836 |
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10033689 |
Dec 28, 2001 |
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10737668 |
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08883246 |
Jun 26, 1997 |
6355050 |
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10033689 |
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08824031 |
Mar 26, 1997 |
6036699 |
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08883246 |
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08259410 |
Jun 14, 1994 |
5779719 |
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08824031 |
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07989611 |
Dec 10, 1992 |
5417699 |
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08259410 |
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Current U.S.
Class: |
606/144 |
Current CPC
Class: |
A61B 2017/00663
20130101; A61B 2017/00867 20130101; A61B 17/0482 20130101; A61B
2017/00004 20130101; A61B 17/06066 20130101; A61F 2210/0019
20130101; A61B 2017/0464 20130101; A61B 17/0625 20130101; A61B
2017/047 20130101; Y10S 604/90 20130101; A61B 2017/00641 20130101;
A61B 2017/0458 20130101; A61B 2017/00637 20130101; A61B 2017/0474
20130101; A61F 2002/30092 20130101; A61B 17/0469 20130101; A61B
17/0057 20130101; A61B 2017/0472 20130101; A61B 17/0401 20130101;
A61B 2017/06057 20130101 |
Class at
Publication: |
606/144 |
International
Class: |
A61B 17/062 20060101
A61B017/062 |
Claims
1. A device for closing an opening in tissue, the device
comprising: an elongated body having a proximal end and a distal
end, a flexible sheath extending from the distal end of the
elongated body and carrying a length of suture, with a cuff molded
on an end of the length of suture, to close the opening in the
tissue, the length of suture being deployable to penetrate the
tissue wall, the elongated body being advanceable toward the
opening along a guidewire to position the length of suture
substantially adjacent the opening, and further comprising at least
one needle advanceable through tissue surrounding the opening to
deploy the length of suture through the tissue wall, the cuff
having an inner space adapted to receive a tip of one needle of the
at least one needle following advancement of the at least one
needle through the tissue.
2. The device of claim 1, wherein the flexible sheath has a distal
end, wherein the flexible sheath defines a guidewire entry port at
or near the flexible sheath distal end, and wherein the flexible
sheath defines a guidewire exit port situated along the flexible
sheath at a location proximal to the guidewire entry port.
3. The device of claim 1, wherein the flexible sheath is sized to
maintain hemostasis at the opening when the flexible sheath is
positioned through the opening.
4. The device of claim 1, wherein the elongated body has a proximal
end and a distal end, and further comprising a flexible sheath
extending from the distal end of the elongated body, the flexible
sheath defining a suture storage lumen.
5. The device of claim 1, wherein the needle has a barbed end for
insertion through the cuff to attach the needle to the length of
suture to deploy the suture through the tissue wall.
6. A device for closing an opening in tissue, the device
comprising: a shaft having a proximal end and a distal end; a foot
near the distal end of the shaft; a length of suture having an end
and a cuff molded on the end of the suture, the cuff being
releasably retained in the foot; and at least one needle arranged
on the device to be advanceable through the tissue surrounding the
opening, the needle having a barbed end for insertion through the
cuff to attach the needle to the suture to draw the suture through
the tissue, the cuff having an inner space adapted to receive a tip
of one needle of the at least one needle following advancement of
the at least one needle through the tissue.
7. The device of claim 6, wherein the cuff is molded as one piece
from the suture material.
8. The device of claim 6, wherein the cuff is a ring and the length
of suture is attached in a perpendicular manner to one side of the
ring.
9. The device of claim 6, further comprising a flexible sheath
extending from the distal end of the shaft, the flexible sheath
defining a guidewire lumen.
10. The device of claim 9, wherein the sheath defines a suture
storage lumen.
11. A method for closing an opening in tissue, the method
comprising: advancing an elongated body, the elongated body having
a proximal end, a distal end, at least one needle, and a flexible
sheath extending from the distal end of the elongated body and
carrying a length of suture with a cuff molded on an end of the
length of suture, along a guidewire to position the length of
suture substantially adjacent the opening, advancing the at least
one needle through tissue surrounding the opening; and deploying
the length of suture through the tissue wall, the cuff having an
inner space adapted to receive a tip of one needle of the at least
one needle following advancement of the at least one needle through
the tissue through the opening.
12. The method of claim 11, further comprising partially
withdrawing the elongated body leaving a portion of the flexible
sheath in the opening to maintain hemostasis.
13. The method of claim 11, further comprising advancing a needle
through the tissue adjacent the opening to attach the needle to a
length of suture.
14. The method of claim 13, further comprising advancing a barbed
end of the needle through the cuff.
15. The method of claim 11, wherein the flexible sheath defines a
guidewire lumen, and the method further comprises positioning a
guidewire through the opening and loading the guidewire into the
guidewire lumen to advance the flexible sheath through the
opening.
16. A method for closing an opening in tissue, the method
comprising: providing a suturing device having a shaft, the shaft
having a distal end; advancing at least a portion the shaft through
the opening; positioning a length of suture on a distal side of the
tissue, the suture having an end and a molded cuff on the end of
the suture; advancing a needle through the tissue adjacent the
opening and through the cuff to attach the needle to the length of
suture; and withdrawing the needle and the suture through the
tissue.
17. The method of claim 16, further comprising providing a flexible
sheath on the distal end of the shaft.
18. The method of claim 17, further comprising partially
withdrawing the suturing device leaving a portion of the flexible
sheath in the opening to maintain hemostasis.
19. The method of claim 17, wherein the flexible sheath defines a
guidewire lumen, and the method further comprises positioning a
guidewire through the opening and loading the guidewire into the
guidewire lumen to advance the suturing device through the
opening.
20. The method of claim 16, further comprising tying a knot in the
suture to close the opening.
21. A method for closing an opening in tissue, the method
comprising: inserting a guidewire through the opening in the
tissue; providing a closing device adapted to penetrate the tissue
and permit closing of the opening carrying an implant with a cuff
molded on an end of the implant; using the guidewire to guide a
portion of the closing device to a position substantially adjacent
the opening; and penetrating the tissue to at least partially close
the opening.
22. The method of claim 21, wherein penetrating the tissue to at
least partially close the opening includes deploying the
implant.
23. The method of claim 22, wherein the implant is a length of
suture.
24. The method of claim 22, further comprising providing a needle
on the closing device and penetrating the tissue wall with the
needle to advance the implant into the tissue wall.
25. The method of claim 24, further comprising: positioning a
portion of the suture on a distal side of the tissue, the molded
cuff releasably retained on the closing device; advancing the
needle through the tissue adjacent the opening and through the cuff
to attach the needle to the length of suture; and withdrawing the
needle and the suture through the tissue.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/737,668, filed Dec. 16, 2003, which is a
continuation of U.S. patent application Ser. No. 10/033,689, filed
Dec. 28, 2001, which is a continuation of U.S. patent application
Ser. No. 08/883,246, filed Jun. 26, 1997, now U.S. Pat. No.
6,355,050, which is a continuation-in-part of U.S. patent
application Ser. No. 08/824,031, filed Mar. 26, 1997, now U.S. Pat.
No. 6,036,699, which is a continuation-in-part of U.S. patent
application Ser. No. 08/259,410, filed Jun. 14, 1994, now U.S. Pat.
No. 5,779,719, which is a divisional and a continuation-in-part of
U.S. application Ser. No. 07/989,611, filed Dec. 10, 1992, now U.S.
Pat. No. 5,417,699. The disclosures of these prior applications are
hereby incorporated by reference in their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to devices and
methods for the suturing of tissue in various applications such as
closure of arterial and venous puncture sites, suturing a graft
anastomosis to an aperture in a vessel wall or other types of
tissue, and the like. More particularly, the inventive devices and
methods provide for suturing the tissue of a vessel even though the
vessel may be under physiological flow and while preferably
maintaining hemostasis.
BACKGROUND OF THE INVENTION
[0003] A number of diagnostic and interventional vascular
procedures are now performed transluminally, where a catheter is
introduced to the vascular system at a convenient access location
and guided through the vascular system to a target location using
established techniques. Such procedures require vascular access
which is usually established using the well known Seldinger
technique, as described, for example, in William Grossman's
"Cardiac Catheterization and Angiography," 3rd Ed., Lea and
Febiger, Philadelphia, 1986, incorporated herein by reference.
[0004] When vascular access is no longer required, the introducer
sheath must be removed and bleeding at the puncture site stopped.
One common approach to attempt providing hemostasis (the cessation
of bleeding) is to apply external force near and upstream from the
puncture site, typically by manual or "digital" compression. This
approach suffers from a number of disadvantages. It is
time-consuming, frequently requiring one-half hour or more of
compression before hemostasis is assured. This procedure is
uncomfortable for the patient and frequently requires administering
analgesics to be tolerable. Moreover, the application of excessive
pressure can at times totally occlude the underlying blood vessel,
resulting in ischemia and/or thrombosis. Following manual
compression the patient is required to remain recumbent for at
least six and at times as long as eighteen hours under close
observation to assure continued hemostasis. During this time
renewed bleeding may occur resulting in bleeding through the tract,
hematoma and/or pseudoaneurism formation as well as arteriovenous
fistula formation. These complications may require blood
transfusion and/or surgical intervention. The incidence of these
complications increases when the sheath size is increased and when
the patient is anti-coagulated. It is clear that the standard
technique for arterial closure can be risky, and is expensive and
onerous to the patient. While the risk of such conditions can be
reduced by using highly trained individuals, such use is both
expensive and inefficient.
[0005] To overcome the problems associated with manual compression,
the use of bioabsorbable fasteners to stop bleeding has been
proposed by several groups. Generally, these approaches rely on the
placement of a thrombogenic and bioabsorbable material, such as
collagen, at the superficial arterial wall over the puncture site.
While potentially effective, this approach suffers from a number of
problems. It can be difficult to properly locate the interface of
the overlying tissue and the adventitial surface of the blood
vessel, and locating the fastener too far from that surface can
result in failure to provide hemostasis and subsequent hematoma
and/or pseudo aneurism formation. Conversely, if the fastener
intrudes into the arterial lumen, intravascular clots and/or
collagen pieces with thrombus attached can form and embolize
downstream causing vascular occlusion. Also, thrombus formation on
the surface of a fastener protruding into the lumen can cause a
stenosis which can obstruct normal blood flow. Other possible
complications include infection as well as adverse reactions to the
collagen implant.
[0006] Catheters are also used to treat heart disease which is a
major medical ailment wherein arteries become narrowed or blocked
with a build-up of atherosclerotic plaque or clot which reduces
flow to tissues downstream or "distal" to the blockage. When this
flow reduction becomes significant, a patient's quality of life may
be significantly reduced. In fact, heart disease patients often die
when critical arteries, such as the coronary arteries, become
significantly blocked.
[0007] However, technology has been developed to open some blocked
arteries in the treatment of heart disease. For example, balloon
angioplasty has become a well accepted treatment wherein a balloon
is inflated within the narrowed vessel to stretch or otherwise
deform the blockage into a larger lumen. Attentively, the blockage
can even be removed, such as in a procedure known as atherectomy.
In general, these treatments use percutaneous catheters which are
inserted into the patients' vessels at a peripheral artery or vein
puncture site and guided to the internal blockage site via x-ray
visualization. The blockage is then treated remotely by use of
hydraulic pressure in the case of balloon angioplasty, or by other
actuating means to cause remote cutting or ablation of the blockage
in the case of atherectomy.
[0008] Coronary Artery Bypass Graft Surgery ("CABG")
[0009] In the alternative to using catheters to treat heart
disease, or when such catheterizations are contraindicated, some
blocked vessels can be treated with coronary artery bypass graft
surgery ("CABG"). In conventional CABG techniques, a tubular graft
is affixed to a port or aperture in an artery wall distally of the
blockage. When the opposite end of the tube is in fluid
communication with a pressurized arterial blood supply, such as the
aorta, the tubular graft provides a conduit for flow into the
vessel lumen distally of the blockage.
[0010] Conventional CABG surgery is generally initiated by directly
exposing the heart to the surgeon. This is accomplished by opening
the patient's chest using known sternotomy and retraction
techniques that cut the sternum and spread the rib cage open. Then,
one or both lungs are usually deflated and the patient is connected
to a respiratory assist machine.
[0011] Once the heart is exposed, the patient is connected to a
coronary bypass machine so that the blood supply circumvents the
heart. In this way, the heart is depressurized so that apertures
can be cut into the walls of the vessels for surgical graft
attachment. The right atrium (or vena cava) and the aorta each is
intubated with cannulas which are connected to an artificial pump
and oxygenator. Once these major vessels are cannulated,
cardioplegia is delivered to slow or stop the beating motion of the
heart. The aorta is then clamped proximally of the aortic bypass
cannula, thereby isolating the proximal aortic root from the blood
that is being circulated by the bypass machine.
[0012] After the heart is isolated from blood pressure,
conventional bypass grafting is performed. The required grafts are
implanted to feed the coronary arteries distal to the blockage, the
clamp is removed from the aorta, the lungs are restored, and the
patient is then taken off of the bypass pump.
[0013] In one type of CABG method, the bypass grafting is achieved
between the aorta and one of the three major coronary arteries or
their sub-branches, the left anterior descending artery (LAD), the
circumflex artery (CIRC), or the right coronary artery (RCA). In
such a case, a saphenous vein is usually taken from the patient's
leg and is transplanted as a "homograft" to connect these vessels
in the same patient's chest. Artificial grafts have also been
disclosed as providing potential utility for this purpose and are
herein collectively included in the general discussion of
"saphenous veins" as used in CABG procedures.
[0014] An alternative CABG method uses the internal mammary artery
(IMA) alone or in conjunction with the saphenous vein graft. The
IMA is severed at a chosen location and is then connected to an
aperture, in a coronary artery.
[0015] In either case of using saphenous vein homografts or
artificial grafts in CABG surgery, the proximal end of the graft is
generally sutured or otherwise is affixed circumferentially to the
tissue surrounding an aperture that is punched into the wall of the
aorta. In this arrangement, the lumen of the graft communicates
with the vessel through the aperture, wherein ideally the aperture
approximates the inner diameter of the graft lumen. The opposite,
distal end of the graft is sutured to an aperture formed in the
wall of the coronary vessel distal to the blockage.
[0016] The fluid connections between a graft and a vessel are
herein referred to as "anastomoses." In the instance of CABG,
"proximal anastomoses" and "distal anastomoses" are terms used when
referring to grafting to the aorta and the coronary artery,
respectively. In most CABG procedures using saphenous vein grafts,
the distal anastomosis is performed first, followed by the proximal
anastomosis.
[0017] For the CABG method using the IMA, only one distal
anastomosis is formed distal to the arterial blockage. A proximal
anastomosis to the aorta is not required as it is in a saphenous
vein graft procedure because the IMA's natural arterial blood flow
feeds the heart.
[0018] In conventional CABG surgery methods such as those just
summarized, the timing and technique of the anastomosis procedures
are critical factors to procedural success. In fact, it is believed
that three critical determinants which affect outcomes of CABG
surgery are: (1) time the patient spends on bypass, (2) time the
patient spends with a clamped aorta, and (3) the quality of the
anastomoses. It is generally believed that a CABG patient's
operative and peri-operative morbidity are directly related to how
long the patient must be on heart bypass. In fact, it is generally
understood that the risk of patient morbidity is believed to rise
significantly after a threshold time of one hour on bypass. Perhaps
the most prevalent complication arising from prolonged cardiac
bypass is the high risk of distal thrombus created by the
artificial plumbing. For example, such thrombi can embolize into
the neurovasculature and potentially can cause a stroke. In
analyzing the timing of individual CABG steps against the backdrop
of a patient's critical time on bypass, the time spent anastomosing
the grafts to vessels emerges as a controlling factor. The average
time for suturing one anastomosis is approximately 7-10 minutes.
Furthermore, it is believed that an average CABG procedure involves
approximately five anastomoses: two saphenous vein grafts, each
with a proximal and a distal anastomosis, and one internal mammary
artery having only one distal anastomosis. Therefore, the average
time for graft suturing ranges from 35 minutes to 50 minutes--in
any case a significant portion of the 60 minute critical threshold
to patient morbidity. Closely related to the time spent on bypass
is a second CABG success factor related to the extent and time of
aortic cross-clamping. It is believed that the inherent crushing
force from a cross-clamp across the bridge of the muscular aortic
arch may be associated with a high degree of tissue trauma and
structural damage. Additionally, hemostasis formed at or adjacent
to the cross clamp, perhaps in conjunction with the tissue trauma
of clamping, may also be a source of unwanted thrombogenesis.
[0019] In addition to the timing of anastomosing grafts and extent
and duration of aortic cross-clamping, the quality of interface
between the graft and vessel is also believed to be an indicator of
procedural success. The accuracy, trauma, and repeatability of
suturing, as well as the three-dimensional interface formed between
the conduits at the anastomosis site, are significant variables in
conventional manual surgical techniques. These variables are
believed to significantly affect the short or long-term success of
conventional CABG anastomosis procedures.
[0020] Limitations of Conventional CABG Devices & Methods
[0021] Both of the critical CABG success indicators summarized
above--time on cardiac bypass and quality of anastomosis
suturing--are directly affected by inherent limitations in the
devices used in conventional CABG procedures. It is believed that
improvements to these devices and related methods of use may
provide for more rapid and reliable vessel-graft anastomosing. For
example, conventional "surgical punches" are devices that cut or
"punch" a plug in vessel wall tissue to form an aperture in the
wall. In a CABG procedure, the tissue surrounding a punched-out
aperture provides the substrate upon which a graft may be sutured
to form an anastomosis. One procedural limitation in using
conventional surgical punches is that hemostasis can not be
maintained at a vessel wall after a plug of tissue is punched out
and removed. Therefore, an aperture in an aortic wall during a
saphenous vein graft procedure can only be made when that portion
of the aorta is cross-clamped, bypassed, and depressurized.
Otherwise, the high blood pressure and flow in the aorta would
cause significant bleeding during the period from punching the
aperture to forming the anastomosis. Because of this limitation in
conventional surgical punches, the threshold 60 minute coronary
bypass clock begins running before punching the aorta.
[0022] The prior art fails to disclose or fulfill the need which
exists in the field of medical devices and methods for: suturing
tissue by proximally drawing sutures through a tissue layer in the
proximity of an aperture; suturing tissue by reversibly advancing
needles from one side of a tissue layer to retrieve one or more
sutures on the opposite side of the tissue layer; a medical device
assembly and method that automatically and repeatably places suture
thread through vessel wall tissue surrounding an aperture in the
vessel wall in a suture pattern that is useful for anastomosing a
tubular graft to the aperture; and a medical device assembly that
deploys a suture with one end extending through the tissue that
surrounds a aperture in a vessel wall and the opposite suture end
extending radially through a tubular graft wall adjacent an open
end of the graft, such that a vessel anastomosis may be rapidly and
repeatably performed in a CABG procedure even while the vessel is
under physiological flow.
SUMMARY OF THE INVENTION
[0023] The present invention provides a device for suturing a
tissue layer having two sides which includes a suture and means for
releasably retaining at least a portion of the suture in a
stationary position on one side of the tissue layer. The device
also includes means for retrieving the portion of the suture
through the tissue layer from the opposite side whereby the suture
is drawn from one side to the opposite side.
[0024] A device is also provided for suturing at least one tissue
layer wherein each tissue layer has two sides. The device includes
a fastener having at least a first and second portion. The first
and second portions have means for securing the first and second
portions together. The first and second portions have a base at one
end to prevent the respective portion from passing completely
through the tissue layer. The device includes means for releasably
retaining the first portion in a stationary position on one side of
the tissue layer and means for driving the second portion through
the tissue layer from the opposite side and securely engaging the
securing means of the first and second portions whereby the base of
the first portion abuts one side of the tissue layer and the base
of the second portion abuts the opposite side of the tissue
layer.
[0025] The present invention provides a device for suturing tissue
in the proximity of an aperture in a tissue layer which include a
shaft having a proximal and distal end and a foot attached to the
distal end of the shaft. The foot is adapted for advancing through
the aperture. At least one needle is carried above the distal end
of the shaft. At least a portion of a suture is releasably retained
on the foot in the proximity of the aperture. The device also
includes means for reversibly advancing the needle through the
tissue to retrieve and draw at least a portion of the suture
through the tissue. The advancing means is integrally formed with
the shaft.
[0026] A device for suturing the wall of a tubular graft having two
sides is also provided by the present invention. The device
includes a suture, means for releasably retaining at least a
portion of the suture on one side of the wall, and means for
retrieving the portion of the length of suture through the wall of
the graft to the opposite side of the wall.
[0027] A graft anastomosis assembly is also provided for suturing a
tubular graft about an aperture in a tissue wall. The assembly
includes a suture, a tissue suturing and graft suturing devices.
The tissue suturing device includes means for releasably retaining
at least a portion of the suture in a stationary position on one
side of the tissue layer and means for retrieving the portion of
the suture through the tissue layer from the opposite side whereby
the suture is drawn from one side to the opposite side. The graft
suturing device includes means for releasably retaining at least a
portion of the suture on one side of the graft and means for
retrieving the portion of the length of suture through the wall of
the graft to the opposite side of the graft.
[0028] A graft assembly for anastomosing a tubular graft and vessel
is also disclosed herein. The graft having a graft wall that
defines a graft lumen with an open end. The graft wall has a
plurality of ports spaced in a predetermined pattern near the open
end. The assembly includes a plurality of sutures in the
predetermined pattern. Each suture has a first suture portion
extending through one of the plurality of ports in the graft wall.
Each suture has a second suture portion extending along at least a
portion of the graft lumen.
[0029] A method for suturing a tissue layer having two sides is
also provided by the present invention. The steps of the method
include: releasably retaining at least a portion of a suture in a
stationary position on one side of the tissue layer; and retrieving
at least a portion of the suture through the tissue layer to the
opposite side.
[0030] Another method of the present invention sutures tissue in
the proximity of an aperture in a tissue wall. The steps of the
method include: forming a port from the proximal side of the tissue
wall; passing at least a portion of a suture from the distal side
of the tissue wall proximally through the port in the tissue wall
in the proximity of the aperture; and forming a loop with the
remaining portion of the suture to secure the suture.
[0031] A further method for suturing an aperture in a vessel wall
is provided herein. The steps of the method include: reversibly
advancing a plurality of needles through the vessel wall to form
ports in the proximity of the aperture; passing at least a portion
of a suture proximally through the ports in the vessel wall
disposed on opposite sides of the aperture from the interior of the
vessel with the remaining portion of the suture passing out of the
vessel; and securing the ends of the suture to close the
aperture.
[0032] Another method of the present invention sutures the wall of
a tubular graft to define a graft lumen and an open graft end. The
steps of the method include: releasably retaining at least a
portion of a suture within the graft lumen and adjacent the graft
open end; puncturing the tubular graft wall with the plurality of
needles to form a plurality of ports in a circumferential pattern;
and drawing the portion of suture outwardly from the graft lumen
and through each of the plurality of ports and external of the
graft wall.
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] In the drawings, which comprise a portion of this disclosure
but are not to scale:
[0034] FIG. 1 is a perspective view of an embodiment of a suturing
device constructed in accordance with the principles of the present
invention;
[0035] FIG. 2A is a detail view of the distal end of the guide body
of the suturing device of FIG. 1, shown with the needles retracted
fully within the guide body;
[0036] FIG. 2B is a view similar to FIG. 2A, except that the
needles have been partially drawn back into the guide body;
[0037] FIG. 3 is a cross-sectional view of the device of FIGS. 2A
and 2B, taken along line 3-3 of FIG. 2B;
[0038] FIGS. 4-7 illustrate the method of the present invention
using the suturing device 30 of FIG. 1;
[0039] FIG. 8 illustrates the X-pattern of the tied suture applied
by the suturing device;
[0040] FIG. 9 is a perspective view of a tissue suturing device of
the present invention inserted through a tissue layer;
[0041] FIG. 10 is an isolated perspective view of the needle
carrier and foot of the tissue suturing device in FIG. 9;
[0042] FIG. 11 is a top view of the foot of the tissue suturing
device in FIG. 9;
[0043] FIG. 12 is a side view of the foot and shaft of the tissue
suturing device in FIG. 9 inserted through a tissue layer;
[0044] FIG. 13 is an isolated perspective view of an alternate
embodiment of the shaft and foot of the tissue suturing device;
[0045] FIG. 14A is a cross-sectional view of the foot along the
lines 14A-D in FIG. 13 illustrating an example of one
cross-sectional shape for the foot;
[0046] FIG. 14B is a cross-sectional view of the foot along the
lines 14A-D in FIG. 13 illustrating another example of one
cross-sectional shape for the foot;
[0047] FIG. 14C is a cross-sectional view of the foot along the
lines 14A-D in FIG. 13 illustrating another example of one
cross-sectional shape for the foot;
[0048] FIG. 14D is a cross-sectional view of the foot along the
lines 14A-D in FIG. 13 illustrating another example of one
cross-sectional shape for the foot;
[0049] FIG. 15 is a side view isolating the engagement of a needle
and suture of the tissue suturing device illustrated in FIG. 9;
[0050] FIG. 16 is a cross-sectional view of the needle and suture
in FIG. 15 along the lines 16-16 with the needle and suture in an
engaged position;
[0051] FIG. 17 is a top view of the needle and suture in FIG. 15
along the lines 17-17 with the needle and suture in an engaged
position;
[0052] FIG. 18A is a side view of the suture end illustrating an
example of a ball shape for the suture end;
[0053] FIG. 18B is a side view of the suture end illustrating an
example of a solid cuff shape for the suture end;
[0054] FIG. 18C is a side view of the suture end illustrating an
example of a ring shape for the suture end;
[0055] FIG. 18D is a side view of the suture end illustrating an
example of a serrated cuff shape having slits for the suture
end;
[0056] FIG. 18E is a side view of the suture end illustrating an
example of a hook shape for the suture end;
[0057] FIG. 19A is a side view of a serrated needle tip
illustrating an example of a retrieving device of the present
invention;
[0058] FIG. 19B is a side view of a needle tip and tubing assembly
illustrating an example of another retrieving device of the present
invention;
[0059] FIG. 19C is a side view of a needle tip with an indentation
illustrating an example of another retrieving device of the present
invention;
[0060] FIG. 19D is a side view of a hook-shaped needle tip
illustrating an example of another retrieving device of the present
invention;
[0061] FIG. 19E is a side view of a needle tip and tubing assembly
illustrating an example of another retrieving device of the present
invention;
[0062] FIG. 20 is a cross-sectional view of two tissue layers being
joined by the present invention using a multi-piece fastener in a
tissue suturing device;
[0063] FIG. 21 is a cross-sectional view of a tissue layer and
suture being joined by the present invention using a multi-piece
fastener in a tissue suturing device;
[0064] FIG. 22 is a cross-sectional view of a suture cuff attached
to two lengths of a suture for use with the present invention;
[0065] FIG. 23 is a top view of an isolated section of tissue layer
having a suture pattern therein formed by a continuous suture used
with the present invention;
[0066] FIG. 24 is a top view of an isolated section of tissue layer
having a purse-string suture pattern therein formed by a single
suture used with the present invention;
[0067] FIG. 25 is a perspective view of another embodiment of a
tissue suturing device of the present invention;
[0068] FIG. 26 is an isolated top view of the foot of the tissue
suturing device of FIG. 25;
[0069] FIG. 27 is a cross-sectional view of an alternate button
embodiment for retrieving a suture loop in the foot of the present
invention;
[0070] FIG. 28 is a top view of a tear shaped button embodiment for
retrieving a suture loop in the foot of the present invention;
[0071] FIG. 29 is a cross-sectional view of the button embodiment
in FIG. 27 for retrieving a suture loop in the foot of the present
invention;
[0072] FIG. 30 is a diagrammatic side view of another embodiment of
a tissue suturing device of the present invention utilizing a
needle carrier and needle retrieval arrangement positioned at an
obtuse angle to the longitudinal axis of the device;
[0073] FIG. 31 is a perspective view of an anastomoses assembly of
the present invention;
[0074] FIG. 32 is an isolated perspective view of the graft
suturing device from the assembly in FIG. 31;
[0075] FIG. 33 is another embodiment of a graft suturing device of
the present invention which retrieves sutures inwardly through a
graft wall;
[0076] FIG. 34 is another embodiment of a graft suturing device of
the present invention which positions the graft through the needle
carrier;
[0077] FIG. 35 is a perspective view of another embodiment of the
graft suturing device of the present invention which retrieves the
sutures in an axial direction;
[0078] FIG. 36 is a cross sectional view of a needle driving device
for retrieving the sutures illustrated in FIG. 35;
[0079] FIG. 37 is a side view of an alternate arrangement for
driving the needles as illustrated in FIG. 36;
[0080] FIG. 38 is a cross-sectional view of a vessel illustrating
the insertion of a foot of the inventive tissue suturing device
from a remote access site;
[0081] FIG. 39 is a cross-sectional view of a vessel illustrating
the insertion of a foot of the inventive tissue suturing device
from a remote access site; and
[0082] FIG. 40 is a cross-sectional view of a vessel illustrating
the insertion of another embodiment of a foot of the inventive
tissue suturing device from a remote access site.
DETAILED DESCRIPTION
[0083] As used herein, the term "distal" is generally defined as in
the direction of the patient, or away from a user of a device, or
in a downstream direction relative to a forward flow of blood. In
the context of a medical device intervention with or through a
vessel wall, "distal" herein refers to the interior or the lumen
side of the vessel wall.
[0084] Conversely, "proximal" generally means away from the
patient, or toward the user, or in an upstream direction relative
to a forward flow of blood. In the context of a medical device
intervention with or through a vessel wall, "proximal" herein
refers to the exterior or outer side of the vessel wall.
[0085] Additionally, "oblong" is herein intended to mean oval,
elliptical, or otherwise having a generally rounded shape that is
not perfectly circular. In particular, the term describes the shape
of a tubular graft end cut at an acute angle relative to the plane
perpendicular to the tissue walls defining the graft.
[0086] The term "hemostasis" is herein used to mean the arrest of
bleeding or substantially blocking flow of blood outwardly from a
vessel lumen while the vessel lumen is pressurized or sustaining
physiological blood flow. This amount of blockage or occlusion to
flow is further defined such that the blood loss which is
experienced is less than an amount which would affect procedural
methods or outcomes according to a physician user of a device of
ordinary skill in the art. In other words, "hemostasis" is not
intended to mean only "total hemostasis" such that there is a total
lack of blood loss. Rather, the term is used to also mean
"procedural hemostasis" as a relative term in its use among
physicians of ordinary skill.
[0087] Similarly, "occlusion," "occlude," "blockage," "block . . .
plugging", "block," or variations thereof are all terms which are
herein intended to have a procedurally relevant definition in the
context of their use. For instance, an aperture is "occluded"
although there is some measurable flow therethrough, but that flow
is so low such that the intended procedural benefit of occlusion is
at least partially achieved. Certainly, such terms also properly
include within their scope a "total effect" definition, as
well.
[0088] The term "perfusion" is herein used to mean the flow of
blood or other unit of perfusate (the fluid used for perfusion) per
unit volume of tissue. Physiological perfusion refers to the amount
of blood flow present when the body is functioning normally. For
example, physiological perfusion usually prevents clinically
significant ST elevations which is one of the most sensitive
indicators of inadequate perfusion. Adequate perfusion refers to
the amount of blood flow that avoids the clinical requirement of
transfusing the patient or that is needed to prevent tissue
necrosis distal to the aperture in the blood vessel.
[0089] The term "suturing" is herein intended to include the
process of joining two surfaces or edges together with a fasten r
so as to close an aperture, opening, or wound or join tissues. The
fastener is usually a suture such as a thread of material (either
polymeric or natural), gut, wire or the like. The term fastener as
used herein also includes clamps, studs, hasps, catches, hooks,
rivets, staples, snaps, stitches, VELCROC, buttons, and other
coupling members.
[0090] Referring to FIGS. 1-3, a suture applying device 400 which
is suitable for suturing and sealing of percutaneous vascular
puncture site, particularly those made to the femoral artery in a
patient's groin, will be described. It will be appreciated,
however, that the device of the present invention can be readily
adapted for use with punctures made to other hollow body organs and
lumens, although it may be necessary to modify the dimensions and
other particular aspects of the device to accommodate the different
usage environment.
[0091] The device 400 comprises a guide body 402 and a needle shaft
404. The guide body 402 includes a guide tip 406 at its distal end,
which guide tip includes a plurality of guide channels 408 which
receive the proximal ends of needles 410. An aligning arrow 403 is
mounted on handle 405 located at the proximal end of the guide body
402. A marker lumen bubble 407 is located below the aligning arrow
and serves to indicate when the distal end of the guide body has
entered a blood vessel, as described in the embodiment below. An
indicator lumen 411 which permits the flow of blood to the marker
lumen bubble 407 is illustrated in FIGS. 2A and 2B.
[0092] The needles 410 as illustrated comprise a sharpened tip
section 412 and an elongate shank portion 414, but may also be
manufactured as an integral piece. The shank portion 414 will be
sufficiently long so that the needles may be pushed from their butt
end by a support holster 428 fixedly attached to the needle shaft
404 in order to advance the needles through the tissue to be
sutured and fully through the guide body 402 inserted together with
support sheath 440 in the associated tract so that no capture
mechanism will be required.
[0093] The guide body 402 further includes a plurality of needle
lumens 420 which are axially aligned and spaced about the periphery
of the guide body. As best seen in FIG. 2B, the needles 410 will
enter the distal ends of the lumens 420 as the needles are advanced
proximally relative to the guide body.
[0094] A flexible needle sheath 426 will be attached to the guide
tip 406 of guide body 402. The central lumen of the needle sheath
426 receives a support holster 428 attached to the distal end of
the needle shaft 404, as well as the needles 410. As with previous
embodiments, the butts of the needles 410 are removably received
within the support holster 428. The sheath 426 will be sufficiently
long to permit the needles to extend at least 5 cm beyond the
distal end of guide body 402.
[0095] Prior to use, the suture applying device 400 will be in the
configuration illustrated in FIGS. 1 and 2A. That is, the needle
shaft 404 will be distally positioned within the guide body 402 and
needle sheath 426. In particular, the tips of needles 412 will lie
just at the guide tip 406 so that they may be easily advanced
through the arterial tissue surrounding the arteriotomy. That is,
the tips of the needles will be generally retracted within the
guide tip 406. A length of suture 422 is attached to the proximal
tips 412 of opposed pairs of needles 410, with the connecting
suture being stored in side lumens 427 extending axially along the
exterior of the needle sheath 426. As best observed in FIGS. 2A and
2B, the suture 422 extending between one pair of opposed needles is
received in a first of the side lumens 427, while the suture
extending between the other pair of opposed needles is received in
the second of the side lumens. While it would be possible to store
the suture 422 in the lumens 420 of the guide body 402 (and thus
eliminate the need for side lumens 427), such storage is less
preferred since it increases the risk that the suture will become
entangled with the needles 410 as they are withdrawn proximally.
The use of side lumens 427 greatly simplifies feeding of the suture
as the needles 410 are withdrawn.
[0096] After the guide tip 406 has been passed through the puncture
site to be sutured, the needles may then be drawn proximally
forward through the tissue to be sutured by drawing proximally on
handle 430 at the proximal end of needle shaft 404. The method of
the present invention will now be described in more detail with
reference to FIGS. 4-7.
[0097] The situation following an interventional or other vascular
procedure, where the attending physician is satisfied that the
puncture site may be sealed, is illustrated in FIG. 4. A
conventional introducer sheath is in place with a guidewire passing
into the femoral artery. The conventional introducer sheath is
withdrawn after assuring that an appropriate guidewire for the
suturing process is in place. The device 400 (including a support
sheath 440 which initially covers the ports to the needle lumens
420) will then be introduced over the guidewire, as illustrated in
FIG. 4. The needles 410 and sutures 422 mostly encased by flexible
needle sheath 426, will be fully advanced into the femoral artery
FA past the arterial puncture site A. Handle 441 on support sheath
440 is then partially withdrawn proximally to expose the needle
lumens 420 (as shown in FIGS. 2A, 2B, and 5). Handle 430 will then
be drawn proximally outward relative to the guide body 402, causing
the needles 410 to pass through the superficial wall of the femoral
artery FA and into the needle lumens 420, as illustrated in FIGS.
2B and 5. The handle 430 may continue to be drawn proximally (i.e.,
outward from the patient) in order to continue to pull the needle
shaft 404 through the guide body 402. Such movement of the needle
shaft 404, in turn, continues to draw the needles 410 outward
through the lumens 420 of the guide body 402 until the tips of the
needles are exposed. The user may then grasp the needles and
continue to draw them out until the suture is available to the
user. The guide body 402 may then be withdrawn from the support
sheath 440, leaving a portion of the needle sheath 426 still in the
puncture site A to maintain hemostasis. The suture can then be tied
and the knot pushed back down through the support sheath 440. The
knot will then only be tightened when the needle sheath is finally
withdrawn from the puncture site A.
[0098] It can be seen that the guide tip 406 deflects the needles
radially outward so that the pattern of four needles engages the
artery wall in an approximately square pattern about the
arteriotomy A. After the sutures are tied and the knots advanced
back through the support sheath 440, the resulting pattern of tied
suture will appear as in FIG. 8 when viewed towards adventitial
surface of the femoral artery FA surrounding the arteriotomy A.
[0099] Device 400 has certain advantages over the previous
embodiments. Since it is not necessary to capture the needles using
an internal capture mechanism, the needles need not have barbs.
Such barbless needles will minimize trauma to the arterial tissue
around the puncture site A and simplify the procedure. The guide
body 402 and guide tip 406 are designed as an integral structure to
assure that needles 410 will be precisely centered around the
puncture site A, and will very reliably enter the needle lumens 420
in guide body 402. Also, tip 406 will occlude the arteriotomy
puncture during the performance of the procedure, providing
hemostasis. Moreover, the entire procedure is simplified, with
fewer discrete steps being performed. The user need only introduce
the device over-the-wire and thereafter draw out the needle shaft
to carry the needles through the tissue to be sutured and outward
through the guide body, where the suture becomes accessible and may
be tied in a conventional manner.
[0100] The present invention also provides several devices which
comprise a graft anastomosis assembly. One of the preferred
embodiments of the graft anastomosis assembly and component devices
depicted in the drawings is inserted through an aperture or hole in
a tissue wall, such as the wall of the distal artery, an aorta, or
other vascular tissue. The assembly mechanically places a
predetermined pattern of sutures in the tissue wall. The aperture
can then be enlarged manually or, optionally, by the assembly
itself, such that the suture pattern is in close proximity to the
circumference of the aperture. The assembly provides a graft to the
tissue wall at the site of the aperture. Preferably, hemostasis is
maintained during a substantial portion of the procedure.
Furthermore, the graft anastomosis assembly and devices can
maintain perfusion beyond the area of the device introduction
through the vascular tissue.
[0101] A preferred embodiment of one component for the graft
anastomosis assembly is a tissue suturing device 10 shown in FIGS.
9-12 which reliably deploys a uniform suture pattern in a tissue
wall 12 defining a blood vessel 14. The tissue suturing device 10
is useable separately for suturing any type of tissue, whether or
not as part of an anastomoses procedure. On the other hand, the
tissue suturing device 10 can be used to deploy sutures in either,
or both, the blood vessel and graft in an anastomosis procedure.
Optionally, the tissue suturing device 10 can interlock with a
graft suturing device, as will be discussed below, to provide
alignment between the suture patterns in the tissue wall 12 and a
graft wall.
[0102] The tissue suturing device 10 includes an elongated body 16
having a distal end 18 and proximal end 20. Referring specifically
to FIG. 9, the tissue suturing device 10 includes a hand grip 22
partially nested within the elongated body 16 and externally
accessible to an operator. The device 10 also includes a needle
carrier 24, a foot 26 attached to a shaft 28 which extends
proximally into the elongated body 16, and an actuating mechanism
referred to generally as 30. Supported within the elongated body
16, the actuating mechanism 30 attaches to the hand grip 22 as
illustrated by the cut-away portion.
[0103] The actuating mechanism 30 includes a cam 32 which is
rotatably secured to the elongated body 16 by a fastener 34. The
cam 32 is integrally formed with the hand grip 22 and pivots in the
directions indicated by arrows 36 using the fastener 34 as the
pivot point. The cam 32 includes a slot 38 located between the hand
grip 22 and the fastener 34 and extending through the cam itself.
The cam 32 slidably connects to the proximal end 40 of the needle
carrier 24 by engaging a peg 42 which is affixed to the needle
carrier 24 and extends perpendicularly therefrom. Moving the hand
grip 22 in the direction of the arrows 36, pivots the cam 32 and
slides the peg 42 along the slot 38. As a result, the needle
carrier 24 travels along the shaft 28 within the elongated body 16
and reversibly moves the distal end 44 of the needle carrier toward
the foot 26.
[0104] As specifically illustrated in FIG. 10, the distal end 44 of
the needle carrier includes an integrally formed cutting blade 46
mounted on a surface approximating the size of the circumference of
the foot 26. One end 48 of the cutting blade is positioned near the
shaft 28 so as to meet the circumference of an initial aperture 52
formed in the tissue wall (as shown in FIG. 9). Preferably, the
cutting blade end 48 rides in a longitudinal groove 54 (as shown in
FIG. 11) formed in the shaft 28 as the distal end 44 of the needle
carrier and the foot 26 are squeezed together. The opposite end 50
of the cutting blade is positioned to enlarge the initial aperture
52 in the direction extending away from the shaft 28. The cutting
blade 46 preferably has a height profile which decreases from the
one end 48 of the cutting blade near the shaft to the opposite end
50 to form a decreasing gradient or slant. The decreasing gradient
of the cutting blade 46 allows the end 48 of the cutting blade to
first engage and cut the tissue wall 12 near the shaft 28. The
cutting blade enlarges the incision toward the opposite end 50 as
the distal end 44 of the needle carrier and foot 26 are squeezed
progressively together. The present invention also includes
embodiments wherein the cutting blade 46 has a uniform height
across its length or a gradient which is increasing from the
cutting blade end 48 near the shaft to the opposite end 50 of the
cutting blade.
[0105] Although one embodiment of the cutting blade 46 and the
actuating mechanism 30 is illustrated, alternative embodiments are
suitable for use with the present invention as may be apparent to
one of ordinary skill in the art. A variety of suitable
punch/cutting devices, such as circular blades, anvils, and the
like, as well as actuating mechanisms, are disclosed in the
following prior documents which are hereby incorporated in their
entirety by reference thereto: U.S. Pat. Nos. 3,104,666; 3,776,237;
4,018,228; 4,216,776; and 5,192,294 and U.S. Des. Pat. No.
372,310.
[0106] The distal end 44 of the needle carrier includes a plurality
of needles 56 attached thereto and extending in a generally
perpendicular direction. The needles 56 are arranged in a
predetermined pattern which matches a desired corresponding suture
pattern 58 (as seen in FIG. 12). The needles 56 are positioned at
approximately uniform intervals around the circumference of the
initial aperture 52 which is enlarged to accommodate a graft (not
shown). The height of each of the needles 56 from the surface of
the distal end 44 of the needle carrier to its tip is slightly
higher than the height of the cutting blade 46 so that the needles
56 engage the tissue wall 12 just as, or slightly before, the
cutting blade 46 engages the tissue wall 12. Having the needles 56
engage the tissue wall 12 before, or simultaneously with, the
cutting blade 46, allows the tissue wall 12 to be captured and
retained in position to form the desired suture pattern 58 even
after the cutting blade 46 enlarges the initial aperture 52. The
circumference of the enlarged aperture is retained in apposition as
the cutting blade 46 completes the incision.
[0107] The foot 26 has a top surface 60 and an opposing bottom
surface 62 as seen in FIG. 11. The top surface 60 faces the distal
end 44 of the needle carrier and has a groove 64 which corresponds
in position to the cutting blade 46 on the distal end 44 of the
needle carrier. The groove 64 is of sufficient size to accommodate
a portion of the cutting blade 46 below the plane of the top
surface 60 to facilitate the making of the incision. The groove 64
has the same depth profile from one end 66 of the groove near the
shaft 28 to the opposite end 68 as the height profile of the
cutting blade 46. Located near the circumference 70 of the top
surface 60 is a plurality of suture channels 72 extending through
the depth of the foot 26 to the bottom surface 62. The pattern of
the suture channels 72 on the top surface 60 corresponds to the
pattern of needles 56 on the distal end 44 of the needle carrier
(as seen in FIG. 10). As the distal end 44 of the needle carrier
travels toward the top surface 60 of the foot, the needles 56 have
sufficient height relative to the length of travel by the needle
carrier 24 to slightly penetrate the suture channels 72.
[0108] Each of the suture channels 72 in the foot are sized to
releasably retain a suture 74 having a suture body or length 78
terminating at one end 76. Preferably, the end 76 of the suture is
releasably retained in one of the suture channels 72. As
illustrated in FIG. 10, a plurality of the sutures lengths 78
extend downward through a lumen 80 in the shaft 28 emerging through
a distal shaft aperture 82. As each suture length 78 emerges from
the shaft, it is positioned within one of a plurality of suture
grooves 84 within the bottom surface 62 of the foot. Each suture
groove 84 extends at least partially from the distal shaft aperture
82 to a respective suture channel 72. The depth of each suture
groove 84 is sufficient to accommodate the width of the suture
length 78 to provide a flush profile to the bottom surface 62. The
end of each suture 76 extends to the respective channel 72 where it
is releasably retained near the top surface 60 of the foot.
Although it is preferred to position the suture end 76
approximately flush with the top surface 60 of the foot, it is
suitable for the suture end 76 to be in any position where it can
be retrieved or engaged by the corresponding needle 56 or other
retrieving device or means when the actuating mechanism 30 squeezes
the foot 26 and the distal end 44 of the needle carrier
together.
[0109] Although a plurality of needles 56 are illustrated on the
needle carrier 24 in a one-to-one correspondence with the suture
channels 72 on the foot 26, the present invention also provides
other embodiments. For example, a single needle or a subset of
needles less than the number of suture channels can be used on the
needle carrier. The single needle or subset of needles engages a
corresponding number of suture channels with a first stroke
bringing the foot and needle carrier together. Upon retrieving a
corresponding number of sutures, the single needle or needle subset
is rotated to a new position after each stroke bringing the foot
and needle carrier together along the shaft 28. Rather than having
the needles deploy simultaneously with a single stroke, a
multi-stroke, successive deployment is used.
[0110] Referring to FIG. 9, the suture lengths 78 extend toward the
proximal end 20 of the elongated body. The suture lengths 78 exit
from the lumen 80 and pass through a longitudinal slot 86 (also
illustrated in FIG. 10) which extends along the length of the shaft
28 and the distal end 44 of the needle carrier. Optionally, the
suture lengths 78 extend from the longitudinal slot 86 to a guide
88 which organizes the sutures. The guide 88 is located on the
external surface of the elongated body near the distal end. The
suture lengths 78 extend through a second guide 90 to a suture
holder 92. The second guide 90 is located near the proximal end 20
of the elongated body. The suture holder 92 releasably retains the
opposite ends 94 of the suture lengths so they may be individually
identified as to their position in the suture pattern 58 and
retrieved by the operator.
[0111] The longitudinal slot 86 allows the removal of the foot 26
from the aperture completed 52 in the tissue wall 12 and the
subsequent removal of the suture lengths 78 so that each end, 76
and 94, of the sutures can be fastened together. In an alternate
embodiment, the suture lengths 78 extend internally along the
length of the elongated body 16 toward the proximal end 20. A seam
98 along the length of the elongated body 16 connects to the end of
the longitudinal slot 86 so that the elongated body can be split
open to remove the suture lengths 78 once the suture pattern 58 has
been completed. The longitudinal slot 86 itself can also be
replaced with a seam to similarly split the shaft 28, foot 26, and
needle carrier 24 to remove the suture lengths 78 from the lumen
80.
[0112] Preferably, the suture pattern 58 is a uniform distance from
the perimeter of the completed aperture 52 in the tissue wall.
Usually, the initial aperture 52 is a simple longitudinal incision.
Preferably, the present invention adjusts for the distance which
the tissue wall 12 surrounding the shaft 28 is offset. As
illustrated in FIGS. 10 and 11, the foot 26 is partially defined by
opposing side walls 100 and end walls which define a heel 102 and
toe 104 for the foot. The side walls 100 bulge slightly outward in
the vicinity of the shaft 28. Specifically, the distance between
the circumference of the shaft and the side walls 100 is the same
as the distance from the cutting blade groove 64 or longitudinal
axis of the foot 26 to the side walls 100 along the remainder of
the foot. Like the remaining suture channels 72, the suture
channels in the vicinity of the bulge, like 106 and 108, are
located at the circumference of the side walls 100 which offsets
suture channels 106, 108 in the suture pattern 58. The offset
suture channels 106, 108 provide a uniform amount of tissue wall
capture around the entire perimeter of the completed aperture 52 by
adjusting the position of the suture pattern 58 for the offset of
the tissue wall 12 on each side of the shaft 28. Usually, the
tissue wall 12 is negligibly offset by the shaft 28 in the
direction of the heel end wall 102 because the shaft is positioned
toward or at the heel end wall 102 of the incision creating the
initial aperture 52. To further minimize the offset of the tissue
wall 12 caused by the shaft 28, it is preferred that the shaft have
an oval shape to its cross-section as specifically illustrated in
FIG. 11.
[0113] The needles 56 on the surface of the distal end 44 of the
needle carrier which correspond to the offset suture channels 106,
108 on the foot are similarly offset. The surface of the distal end
44 of the needle carrier in the vicinity of the shaft 28 is offset
or bulges in a similar pattern as the opposing side walls 100 of
the foot.
[0114] FIG. 12 illustrates a side view of the foot 26 upon
insertion through the initial aperture 52 in the tissue wall 12.
Preferably, the toe end wall 104 is inserted first and moved
forward. The shaft has a cut-away portion 110 near its distal end
to allow forward movement of the foot assisting the insertion of
the heel end wall 102 through the tissue wall 12. The heel end wall
102 is then moved back slightly to abut one end of the initial
aperture 52. The top surface 60 of the foot 26 abuts the distal
side 112 of the tissue wall promoting uniform tissue capture when
the needles engage the top surface 60 of the foot. As the foot 26
passes through the tissue wall 12, the dilated tissue around the
aperture 52 usually responds elastically and compresses onto the
shaft 28, thereby maintaining hemostasis. Once in position, the top
surface 60 of the foot lies adjacent the distal side 112 of the
tissue wall, allowing adequate perfusion beneath the bottom surface
62 of the foot and the vessel wall intima 114. When the assembly is
used on vascular tissue, the perimeter of the shaft is preferably
about equal to the perimeter of the incision. For example, using
the tissue suturing device 10 to perform an anastomosis on the
distal artery places the diameter of the shaft in a preferred range
of about 1.5 mm to about 2 mm which is the generally accepted
diameter of the distal artery.
[0115] In those operations where the initial aperture 52 is formed
by incising the tissue wall 12 or punching a hole of a size
approximating the diameter of the shaft 28 in the tissue wall,
there is significantly less offset of the tissue wall in the
vicinity of the shaft. As a result, a nearly uniform suture pattern
58 is formed without the foot 26 having offset suture channels. As
illustrated in FIG. 13, the present invention includes an
embodiment of the foot 26 which does not have an offset or bulge in
the side walls 100 in the vicinity of the shaft 28. The same
reference numerals are used for like components illustrated in the
other figures. FIG. 13 also illustrates the shaft 28 having a more
round cross-section shape. The foot 26 can be formed in many other
shapes and sizes while employing the inventive concepts described
herein to a particular surgical procedure, suture pattern, specific
tissue, etc.
[0116] As illustrated in FIG. 14A, one preferred embodiment of the
foot 26 has a rounded shape to the corners and edges of the top 60
and bottom 62 surfaces to provide for an atraumatic entry through
the tissue wall and to guard against traumatizing the tissue wall
intima opposite the aperture 52 upon advancing the foot 26 into the
lumen of the blood vessel 14 as previously seen in FIG. 12. Another
example illustrated in FIG. 14B emphasizes an even more rounded
bottom surface 62 than FIG. 14A to guard against traumatizing the
vessel wall intima 114 opposite the initial aperture 52.
[0117] The foot 26 can also have several cross-sectional
configurations as illustrated in FIGS. 14C and 14D for example,
which provide a passageway 115 along the longitudinal axis of the
foot for perfusion when the foot has been inserted through the
tissue wall 12 into a vessel 14 (as seen in FIG. 12). FIG. 14C
provides the longitudinal passageway 115 along the length of the
foot 26 from the heel end wall 102 to the toe end wall 104. FIG.
14D provides an example of a longitudinal passageway 115 to ensure
perfusion being used in combination with a curved top surface 60 to
the foot to minimize distortion of the proximal side of the tissue
wall 12. A rounded bottom surface 62 prevents traumatizing the
vessel wall intima 114 opposite the aperture 52. The suture
channels 72 are positioned at an angle to the top surface 60 of the
foot so that they are still perpendicular to the needles 56 on a
corresponding needle carrier 24 (as seen in FIG. 10).
[0118] Other examples of perfusion passageways include pathways
which have a baffled or tortuous path. A coiled path is another
example of a non-straight perfusion passageway.
[0119] Turning now to FIGS. 15-17, the relationship between the
sutures 74 and needles 56 is described in more detail. One end 76
of each of the sutures preferably terminates with a cuff 116
attached to the suture length 78 along a bottom exterior wall 118.
The cuff 116 has a generally cup-shape interior space 120 defined
by a side interior wall 122 and a bottom interior wall 124. The
interior space 120 is sized to accommodate one of the needles 56 in
a press-fit engagement. The distal end 126 of each needle has an
arrowhead shape with a tip 128 and one or more barbs 130. The
arrowhead is mounted on a needle shaft 132 which has a tapered
section 134 near the arrowhead.
[0120] As specifically illustrated by FIGS. 16 and 17, when the
needle 56 engages the interior space 120 of the cuff, the diameter
of the arrowhead barb 130 is sized to be slightly larger than the
interior diameter of the cuff interior space 120. As a result, the
cuff side wall 122 deflects slightly as the arrowhead barb 130 is
inserted into the interior space. The deflected side wall 122 is
biased against the barb 130 to provide a retaining force. The tip
128 of the arrowhead continues until the interior side 124 of the
bottom wall is engaged as a backstop to prevent further insertion
of the arrowhead tip 128. Penetration of the tip 128 into the
interior bottom wall 124 is not required to provide an engaging
force between the needle 56 and the suture 74.
[0121] For the sake of example, and not to be limited thereby, the
preferred dimensions of the needle 56 are in a range of about a
0.01 inch to about a 0.02 inch needle shaft 132 diameter which
decreases to a diameter of about 0.005 inch in a tapered section
134. The length of the tapered section 134 at the narrowest
diameter is about 0.005 inch with an overall length of about 0.013
inch. The diameter of the arrowhead barb 130 is in the range of
about 0.007 to about 0.008 inch. The height of the arrowhead barb
130 is in the range of about 0.010 inch to about 0.014 inch. The
height of the interior side of the side wall 122 is about 0.02 inch
with the cuff 116 having an overall height of about 0.03 inch. The
diameter of the interior space 120 from the interior side of the
side wall 122 is about 0.005 inch. The thickness of the side wall
122 is about 0.0025 inch and the bottom wall 118 is about 0.01
inch. The dimensions of each suture channel 72 in the foot 26 for
this particular example have an interior diameter at the top
surface 60 of the foot of about 0.011 inch.
[0122] The suture cuff 116 is preferably welded to the suture
length 78 or molded as one-piece from polypropylene. The cuff 116
can be made from other medical polymers or malleable metals with a
preferred hardness to provide the retaining force by allowing the
arrowhead barb 130 of a needle 56 to deflect and bias the side wall
122 of the cuff against itself and/or allow the barbs 130 of a
needle to penetrate the side wall 122 of the cuff.
[0123] Other means of attaching the suture length 78 to the cuff
116 are also suitable for use in the present invention such as
attaching the cuff to the suture length with a conventional
adhesive like cyanoacrylate or by forming the cuff with an
indentation in the exterior side 118 of the bottom wall and
crimping the suture length therein. In another embodiment, the
bottom wall 124 of the cuff can be made of the same, or different,
polymer which exhibits a surface hardness sufficient to resist
penetration of the tip 128 and provide a backstop preventing
excessive penetration. The cuff 116 may also be initially molded as
a solid block and subsequently bore an interior space 120 into the
solid block to complete the cuff.
[0124] Preferably, the suture length 78 is a single strand or
monofilament. Although a multi-stranded, covered, twisted, or
braided suture length is also suitable for use with the present
invention. The cuff 116 is also preferably removable from the
suture length 78. A suitable rupture strength of the cuff and
suture length attachment is about 2 ounces to about 10 ounces so
that the two may be separated with the application of a sharp
tug.
[0125] The present invention provides other configurations for the
suture end 76. Illustrated for the sake of example, and not for
limitation, FIGS. 18A-E are suture ends 76 which can be retrieved
or fetched by a retrieving device. The suture end 76 in FIG. 18A
includes a suture length 78 having a ball-shaped end 136 which is
made of a soft material. Similarly, the suture end 76 in FIG. 18B
includes a suture length 78 attached to a solid cuff 138 made of a
soft material.
[0126] The suture end 76 of FIG. 18C includes the suture length 78
attached in a perpendicular manner to one side of a ring 140. Made
of deformable material, the ring 140 compresses in the suture
channel (not shown) as the larger diameter arrowhead barb is
inserted entirely through the hole 142 so that the ring is
positioned above the barbs in the tapered section of the needle
shaft. As the compressed material relaxes, the ring 140 is retained
in the tapered section as the needle is withdrawn through the
tissue wall. One end 144 of the ring is preferably tapered to allow
for easy passage through the tissue layer. Another example of a
retrieving device for use with the ring 140 is a hook as described
further below.
[0127] The suture end 76 of FIG. 18D includes the suture length 78
attached to a cuff 146 defined by a serrated side-wall 148
providing slits 150 therein. The barbs of the needle previously
discussed easily deform the side wall 148 and at least partially
fill into one or more of the slits 150 to provide a solid
engagement therebetween.
[0128] The suture end 76 of FIG. 18E includes the suture length 78
which terminates in a hook-shaped end 152 made of a material
sufficiently hard to resist flexing as it is pulled through the
tissue layer. Configurations of the suture end like the hook-shaped
end 152 can be engaged by a retrieving device like, for example, a
similarly shaped hook or by passing the hook-shaped end through the
center of a retrieving device having a ring shape.
[0129] Other configurations of the retrieving device provided by
the present invention are illustrated for example, and not
limitation, in FIGS. 19A-E. Preferably, the retrieving device of
the present invention generally includes means for forming a port
in the tissue layer through which a suture, or other fastener, is
retrieved or introduced. The suture or fastener usually remains
within the port.
[0130] Specifically, another configuration suitable for impaling
the suture-end is illustrated in FIG. 19A as a serrated needle tip
154 effectively using a plurality of barbs like 156, 158 at various
positions and elevations along the shaft 132 of the needle to
engage the suture end.
[0131] FIG. 19B retrieves the suture length 78 with a multiple
piece assembly 160 having the needle shaft 132 with a tapered
section 134 near the tip 128. A separate piece of tubing 162 in the
tapered section 134 is initially retracted towards the upper
portion 164 of the tapered section until the suture length 78 is
biased into an indentation 166 in the bottom 168 of the tapered
section. As the needle shaft 132 is withdrawn, the tubing 162
slides downward to the bottom 168 of the tapered section and over
the suture length 78 to retain it in place. The tubing 162 can
further be configured to have an offset 170 at its bottom end to
accommodate the thickness of the suture length 78 while
simultaneously covering the portion of the suture resting in the
indentation 166. Optionally, the needle shaft 132 having the
tapered section 134 can be used without the tubing 162.
[0132] FIG. 19C shows the suture length 78 retained within an
indentation 172 of the otherwise barbless needle shaft 132 with the
aid of a suture loop 174 formed in the shape of a noose with a
clasp 176. In place of the clasp 176, the noose can also be formed
by tying a knot in the suture loop 174.
[0133] Another example of a retrieving device is illustrated in
FIG. 19D with the needle shaft 132 having a hook-shaped end 178
with a tip 180 suitable for piercing the tissue layer. Optionally,
the hook-shaped end 178 can further include an inwardly facing barb
182 for assistance in retaining the suture end within the bight of
the hook-shaped end. Examples of a suture end suitable for use with
the hook-shaped end 178 are shown in FIGS. 18C and 18E.
[0134] FIG. 19E illustrates another retrieving device having a
cannula with a lumen or tube 184 with a removable piercing element
such as a needle 186 located within the interior of the tube. The
needle 186 is initially used to form a port in the tissue layer to
atraumatically introduce the tube 184 through the tissue within the
proximity of the suture end. The needle 186 is subsequently removed
and the interior of the tube 184 is placed under a vacuum
sufficient to draw the suture end to the end 188 of the tube. The
tube 184 engaged to the suture end is then drawn through the tissue
layer. Examples of a suture end suitable for use with the tube 184
are shown in FIGS. 18A and 18B.
[0135] The present invention provides other means for engaging a
portion of a fastener through a tissue layer from the side opposite
means for retaining another portion of the fastener in a stationary
position. The present invention provides for using a variety of
fasteners to form different types of suture patterns. Other
examples of the engaging means for a fastener are illustrated in
FIGS. 20 and 21.
[0136] In FIG. 20 a first tissue layer 200 and second tissue layer
202 are joined by releasably retaining a first portion of a
fastener 204 in a stationary position on one side of the first
tissue layer. As previously described, the first portion 204 can be
releasably retained in the foot 26 of a tissue suturing device. A
second portion of the fastener 206 is releasably retained in the
distal end 44 of the needle carrier of the tissue device. The
second portion 206 includes a needle tip 208 on a needle shaft 210
for piercing and forming a port 212 in the first and second tissue
layers. The second portion 206 also includes a base 214 for
abutting the second tissue layer 202 and a barb 216 on the needle
shaft for engaging and being retained in an indentation 218 formed
in the first fastener portion 204. The first fastener portion 204
includes a face 220 for abutting the first tissue layer 200. As the
distal end 44 of the needle carrier is squeezed toward the foot 26,
the needle tip 208 engages the indentation 218 and the first and
second portions of the fastener 204, 206 are retained together. As
a result, the first and second tissue layers 200 and 202 are held
in apposition.
[0137] FIG. 21 illustrates a tissue lay r 222 and a suture 224 are
joined by releasably retaining a first portion of a fastener 204 in
a stationary position on one side of the tissue layer 222. As
previously described, the first portion 204 can be releasably
retained in the foot 26 of a tissue suturing device. A second
portion of the fastener 206 is releasably retained in the distal
end 44 of the needle carrier of the tissue device. The second
portion 206 includes a needle tip 208 on a needle shaft 210 for
piercing and forming a port 212 in the tissue layer 222. The second
portion 206 also includes a base 214 for abutting the tissue layer
222 and a portion of the suture 224. A barb 216 on the needle shaft
passes through an aperture 226 in the first fastener portion 204
and is retained therein. The first fastener portion 204 includes a
face 220 for abutting the opposite side of the tissue layer 222. As
the distal end 44 of the needle carrier is squeezed toward the foot
26, the needle tip 208 passes through the aperture 226 and the
first and second portions of the fastener 204, 206 are retained
together. As a result, the first and second portions of the
fastener secure the suture 224 therebetween.
[0138] The present invention is not limited to retrieving a suture
only at its end. As illustrated in FIG. 22, another embodiment of
the cuff 116 attaches directly to a suture length 78 and not the
terminal end 76 of the suture forming two lengths 230, 232 of the
suture extending from the exterior bottom wall 118 of the cuff.
Although the cuff 116 can be integrally formed as one-piece with
the suture length 78, the cuff can be attached to the suture length
with a conventional adhesive. The suture length 78 can be one of a
plurality of sutures that are deployed to form the suture
pattern.
[0139] The suture length-cuff attachment illustrated in FIG. 22 can
be used to form a suture pattern 58 in proximity to the aperture 52
in the tissue layer as illustrated in FIGS. 23 and 24 using either
a single or a continuous suture. Using suture cuffs 116
periodically attached along the length of a continuous suture 234
as described in FIG. 22, the cuffs 116 are releasably retained in
the suture channels 72 of the foot 26 as previously described. The
needles 56 penetrate the tissue wall 12 forming a port 236 to
engage each cuff 116, and pull each cuff through the tissue wall.
Each cuff 116 is removed from the attached two ends 230, 232 of the
suture length to form a suture loop 238 which proximally extends
through and returns distally through the tissue wall at each port
236. Each suture loop 238 is exposed on the proximal side 240 of
the tissue wall can be utilized in several ways such as by
attaching one or more separate sutures like 242, fasteners, or
anchors on the proximal side 240 of the tissue wall in order to
attach a graft (not shown) or to close the aperture 52. For
example, a corresponding plurality of separate sutures such as 242
attached at one end to a graft can be passed through each of the
exposed suture loops 238. Each separate suture 242 can also
accommodate an anchor therethrough so that as the lengths 230 and
232 of the suture are pulled to draw each of the suture loops 238
approximately flush with the proximal side 240 of the tissue wall.
The separate sutures 242 can also be tightened to bring the graft
in apposition with the proximal side 240 of the tissue wall. The
separate sutures 242 can then be tied off.
[0140] As illustrated in FIG. 24, a purse-string suture pattern 246
in proximity to the aperture in the tissue layer uses a single
suture 248 having free ends 250. To prevent drawing the suture
loops 238 completely through the tissue layer, a conventional
anchor 244 is positioned underneath each suture loop 238 at each
port 236 and pulling the free ends 250 of the suture to draw the
pattern closed. This suture pattern 246 would be useful, for
example, to close a puncture site or aperture 52.
[0141] Another embodiment of the inventive tissue suturing device
310 is shown in FIGS. 25-26. The tissue suturing device 310
includes an elongated body 316 having a distal 318 and proximal 320
end. An actuating mechanism (not shown for clarity) operates a foot
326 in a reversible motion against the distal end 344 of a needle
carrier 324 using a shaft 328. The distal end 344 of the needle
carrier optionally includes integrally formed cutting blades like
346 on each side of the shaft mounted on a surface approximating
the size of the circumference of the foot 326. The distal end 344
of the needle carrier includes a plurality of needles 356 attached
thereto and extending in a generally perpendicular direction. The
needles 356 are arranged in a predetermined pattern which matches a
corresponding suture pattern 358. The needles 356 are positioned at
approximately uniform intervals around the circumference of the
completed aperture which is being enlarged or slit to accommodate a
graft (not shown). The height of each of the needles 356 from the
surface of the distal end 344 of the needle carrier to its tip is
higher than the thickness of the tissue layer the needles 356 are
anticipated to penetrate.
[0142] The foot 326 has a top surface 360 facing the distal end 344
of the needle carrier and an opposing bottom surface 362. Located
on the top surface 360 is a plurality of suture channels 372
extending at least partially into the depth of the foot. The
pattern of the suture channels 372 on the top surface corresponds
to the pattern of needles 356 on the distal end 344 of the needle
carrier. As the distal end 344 of the needle carrier slides along
the shaft 328 towards the foot, the needles 356 on the distal end
have sufficient height relative to the length of travel by the
needle carrier 324 to penetrate the suture channels 372.
[0143] Each of the suture channels 372 in the foot are sized to
allow insertion by the tip 380 of the needles. The top surface 360
releasably retains the sutures, preferably loops 382 formed by one
or more of the sutures. A plurality of suture lengths 378 extend
downward through grooves 384 in the shaft emerging along the top
surface 360 of the foot to be positioned within one of a plurality
of suture grooves 386 within the top surface of the foot. Each
suture groove 386 extends at least partially from the grooves on
the shaft to a respective channel 372. The depth of each suture
groove 386 is sufficient to accommodate the width of the suture to
provide an approximately flush profile to the top surface 360. Each
suture length 378 extends to the respective channel 372 where it is
releasably retained near the top surface 360 of the foot. Although
it is preferred to position the suture length 378 approximately
flush with the top surface 360 of the foot, it is suitable for the
suture length 378 to be in any position where it can be retrieved
by the corresponding needle 356 when the actuating mechanism
squeezes the foot 326 and distal end 344 of the needle carrier
together.
[0144] As specifically shown in FIG. 26, each suture length 378
extends from the groove 386 in the top surface of the foot and
forms the suture loop 382 in a stationary position around the
respective suture channel 372. The respective needle 356 travels in
a perpendicular direction into the suture channel 372. The suture
loop is tensioned or biased towards the needle 356, preferably by
being positioned to slightly overlap the path of travel expected
for the needle 356. As the needle 356 is inserted into the suture
channel 372, the suture loop 382 is positioned to engage the side
of needle shaft 388 near the needle tip 380. As the needle 356
continues its downward insertion, the suture loop 382 is pushed
slightly to one side until the needle 356 has been inserted
sufficiently deep for the indentation 390 in the side of the needle
shaft 388 to reach the suture loop 382. The tension on the suture
loop 382 biases it toward the needle shaft 388 so the suture loop
slides into the indentation 390 in the needle shaft given the
opportunity for the suture loop to return to its initial position.
It is not necessary to move the suture loop 382 toward the needle
shaft 388 to engage the indentation 390. Proper position of the
suture loop 382 relative to the side of the needle shaft 388
creates the desired bias to have the suture loop return to its
starting position when the indentation 390 is adjacent the suture.
Subsequently removing the needle 356 from the suture channel 372
back through the tissue layer pulls the suture loop along and
passes it through the tissue layer.
[0145] Other embodiments of retaining the suture length 378 in the
suture channel 372 are shown in FIGS. 27-29. The suture channel 372
in the top surface 360 of the foot retains a button 392 made of
deformable material in a press-fit. Alternately or in combination
therewith, the button 392 is supported from the inside of the foot
by an elastic tube or spring 394 which is positioned between the
button and the bottom 362 of the foot.
[0146] As specifically shown in FIG. 28, the button 392 has a
preferred tear-drop shape so that the suture loop 382 fits between
the bottom and the edge of the suture channel 372. The suture loop
382 is tensioned or biased against the button 392 as previously
discussed. The button 392 includes an outer surface having an
indentation 396 accessible to the needle 356 from the exterior side
of the top surface 360 of the foot as seen in FIG. 27. As the
needle tip 380 is inserted into the outer surface indentation 396,
the button 392 is not depressed by the needle 356 until the
indentation 390 or barb of the needle shaft is about even with the
outer surface of button to align the suture 382 with the barb or
needle indentation 390. As seen in FIG. 29, the needle 356 further
depresses the button 392 which releases the suture loop 382 which
slides into the barb or needle indentation 390. The needle 356 is
withdrawn and pulls the suture loop 382 back through the suture
channel 372 and, subsequently, through the tissue layer.
[0147] Although the embodiments of the tissue suturing device
discussed above show the needles 358 penetrating the tissue layer
from a perpendicular direction into a foot having a flat or planar
top surface 360, the present invention is not so limited. Another
embodiment 510 of the inventive tissue suturing device is shown in
FIG. 30. The tissue suturing device 510 includes an elongated body
516 having a distal end. An actuating mechanism (not shown for
clarity) operates the foot 526 in a reversible motion against the
distal end 544 of a needle carrier using the shaft 528. The distal
end 544 of the needle carrier optionally includes integrally formed
cutting blades 546. The distal end 544 of the needle carrier
includes a plurality of needles 556 attached thereto. The needles
556 are positioned near the circumference of the distal end 544 of
the needle carrier and extend downward toward the foot 526 and
inward toward the shaft 528 forming an obtuse angle relative to the
side surface of the elongated body 516.
[0148] The foot 526 has a curved top surface 560 facing the distal
end 544 of the needle carrier and a curved opposing bottom surface
562. Located on the top surface 560 is a plurality of suture
channels 572 extending at least partially into the depth of the
foot 526. The pattern of the suture channels 572 on the top surface
560 corresponds to the pattern of needles on the distal end 544 of
the needle carrier. As the distal end 544 of the needle carrier
slides along the shaft 528 allowing the foot 526 to travel towards
the distal end, the needles 556 on the distal end have sufficient
height relative to the length of travel by the foot to penetrate
the suture channels.
[0149] Each of the channels 572 in the foot are sized to allow
insertion by the tip 580 of the needles. A plurality of suture
lengths 578 extend downward through grooves 584 in the shaft
emerging along the top surface 560 of the foot to be positioned
within one of a plurality of suture grooves within the top surface
of the foot. Each suture length 578 is positioned where it can be
retrieved by the corresponding needle 556 when the actuating
mechanism squeezes the foot and distal end of the elongate body
together in the manner described above.
[0150] Another preferred embodiment of a tissue suturing device 610
is illustrated in FIG. 31. The actuating mechanism 630 includes a
motor 682 secured to the elongated body 616. The motor 682
rotatably connects at one end to a worm gear 684 which connects to
the proximal end 640 of the needle carrier. The hand grip 622
includes a switch 686 connected to the motor 682 to control the
direction and number of revolutions by the worm gear 684.
Activating the switch 686 energizes the motor 682 to turn the worm
gear 684 and advance the needle carrier 624 along the shaft 628
within the elongated body 616. Once the needle carrier 624 has
advanced to retrieve the sutures in the foot 626, the motor 682 is
stopped by manually deactivating the switch 686 or by using an
automatic cut-off. The switch 686 can then be activated to have the
motor 682 turn the worm gear 684 in the opposite direction and
reverse the travel of the needle carrier 624 to pass the sutures
proximally through the tissue. A power source 688 for the motor 682
is included within the elongated body 616 although an external
power source can also be used.
[0151] FIG. 31 also illustrates a graft anastomoses assembly 700
which includes a graft suturing device 710 as a second component. A
preferred embodiment of the graft suturing device 710 is
illustrated in FIGS. 31 and 32. The graft suturing device 710
reliably deploys a uniform graft suture pattern in a graft wall.
The graft suturing device 710 is useable separately for suturing
any type of graft, whether or not as part of an anastomoses
procedure. Optionally, the graft suturing device 710 can interlock
with a tissue suturing device like 610 to provide alignment between
the suture patterns in the tissue wall and a graft wall The graft
suturing device 710 includes a graft needle carrier 724, a graft
foot 726 attached to a shaft 728 which extends into the elongated
body 616 of the tissue suturing device 610, and the actuating
mechanism 630 which can be the same as used by the tissue suturing
device 610.
[0152] The graft needle carrier 724 includes a distal end 744
having a mounting surface with an integral cutting blade 746
thereon. The cutting blade 746 has a circular shape. The distal end
744 of the needle carrier includes a plurality of graft needles 756
attached thereto and extending in a generally perpendicular
direction. The graft needles 756 are arranged in a predetermined
pattern which matches a corresponding graft suture pattern 758. The
graft needles 756 are positioned at approximately uniform intervals
around the circumference of the wall of the graft end 782 (as seen
in FIG. 32). The height of each of the graft needles 756 from the
surface of the distal end 744 of the graft needle carrier to its
tip 780 is slightly higher than the height of the graft cutting
blade so that the needles engage the graft wall just as, or
slightly before, the edge of the cutting blade 746 engages the wall
near the graft end 782. Having the needles 756 engage the wall near
the graft end 782 before, or simultaneously with, the cutting blade
746 allows the wall of the graft end 782 to be captured and
retained in position to form the desired suture pattern 758 even
after the edge of the cutting blade 746 cuts the wall near the
graft end 782.
[0153] Another suitable embodiment of the cutting blade 746
preferably has a decreasing depth profile forming a decreasing
gradient or slant from the one side of the graft needle carrier
724. The decreasing gradient allows the end of the cutting blade
edge to engage and cut the graft end 782 in an oblong shape. The
edge of the cutting blade makes the cut as the distal end 744 and
graft foot 726 are squeezed progressively together. The present
invention also includes embodiments wherein the cutting blade 746
has a uniform height across its length. An oblong shape or other
desired shape can still be formed with a cutting blade 746 of
uniform height by changing the circular shape of the cutting blade
on the surface of the distal end 744 to the desired shape.
[0154] Referring specifically to FIG. 31, the graft foot 726 has a
top surface 760 facing the distal end 744 of the graft needle
carrier and an opposing bottom surface. The top surface 760 has a
graft groove which corresponds in position to the graft cutting
blade on the distal end 744 of the graft needle carrier. The graft
groove is of sufficient size to accommodate a portion of the edge
of the graft cutting blade below the plane of the top surface to
facilitate the making of the cut. Located near the circumference of
the top surface is a plurality of suture channels 772 extending
through the depth of the graft foot to the bottom surface. The
pattern of the suture channels 772 on the top surface corresponds
to the pattern of graft needles on the distal end 744 of the graft
needle carrier. As the distal end 744 of the graft needle carrier
travels toward the top surface of the graft foot, the graft needles
756 have sufficient height relative to the length of travel by the
graft needle carrier 724 to penetrate the channels 772.
[0155] Each of the suture channels 772 in the graft foot are sized
to releasably retain a suture length 778, preferably the end 776 of
the suture as previously described. Although it is preferred to
position the suture end 776 approximately flush with the top
surface of the foot, it is suitable for the suture end to be in any
position where it can be retrieved or engaged by the corresponding
graft needle 756 or other retrieving device or means when the
actuating mechanism squeezes the foot and the needle carrier
together. The suture lengths 778 extend within a lumen 780 in the
graft shaft 728 to the surface of the distal end 744 of the graft
needle carrier where a slot in the cutting blade allows the suture
lengths 778 to extend to the external side of the elongated body
616 as previously described with regard to the tissue suturing
device 610. The graft shaft 728 extends to connect to the shaft 628
of the tissue suturing device or can be integrally made as a
one-piece member.
[0156] The actuating mechanism 630 connects to the graft needle
carrier 724 in the same manner as between the actuating mechanism
and the needle carrier 624 of the tissue suturing device 610 in any
of the embodiments previously described. FIG. 31 illustrates one
such embodiment wherein the actuating mechanism includes the motor
682 secured to the elongated body. The motor 682 rotatably connects
on the opposite end to a second worm gear 784 which connects to the
proximal end 740 of the graft needle carrier. The hand grip 622
includes a switch 686 connected to the motor to control the
direction and number of revolutions by the worm gear. Activating
the switch energizes the motor to turn the worm gear and advance
the needle carrier along the shaft within the elongated body. Once
the graft needle carrier 724 has advanced to retrieve the suture
ends 776 in the foot 726, the motor is stopped by manually
deactivating the switch or by using an automatic cut-off. The
switch 686 can then be activated to have the motor turn the second
worm gear 784 in the opposite direction and reverse the travel of
the needle carrier to pass the sutures proximally through the
tissue. Although one embodiment of the cutting blade and the
actuating mechanism is illustrated, alternative embodiments are
suitable for use with the present invention as may be apparent to
one of ordinary skill in is the art.
[0157] Two other embodiments of a graft suturing devices 810 are
shown in FIGS. 33-34 wherein the needles and suture channels are
positioned on the opposite components of the device compared to the
previously described embodiments. The graft suturing devices 810
integrally mounts the foot 826 on the proximal end 820 of the
elongated body 816. A shaft 828 extends from the proximal end 820
of the elongated body 816 to connect to the needle carrier 824 and
to an actuating mechanism (not shown). A graft 800 is pulled over
the needle carrier 824 and extends toward the foot 826. The foot
826 includes suture channels 872 which releasably retain sutures
874 and are in alignment with needles 856 on the needle carrier. As
previously described, the needles 856 move axially to engage the
sutures 874 and retrieve the sutures through the graft 800.
[0158] Specifically, FIG. 33 ties one end 802 of the graft to the
shaft 828 with a tie 804. A cutting blade 846 is located inwardly
of the needles 856 toward the shaft 828. As a result, when the foot
826 and needle carrier 824 are drawn together, the sutures 874 will
be drawn through the graft 800 from the external wall 806 to the
internal wall 808. The sutures 874 can then be pulled out through
the open end 802 of the graft once the graft is removed from the
needle carrier 824.
[0159] In FIG. 34, the graft 800 is positioned over the shaft 828
and pulled through the needles carrier 824. The graft 800 is
further positioned over the top surface 860 of the foot to provide
the cutting blade 846 with proper alignment to cut the graft in the
proximity of the end 802. Since the graft 800 extends through the
needle carrier 824, an indexing device 830 provides the proper
alignment for the needles 856 to engage the sutures 874 and for the
cutting blade 846 to cut the graft end 802. Optionally, the needle
carrier 824 may be detachable from the remainder of the graft
suturing device 810.
[0160] Another embodiment of a graft suturing device 910 is shown
in FIGS. 35-37 which includes a graft needle carrier 924, a graft
foot 926 attached to a shaft 928. Optionally, the graft shaft 928
may extend into the graft anastomosis assembly. A graft 900 is
positioned coaxially about the graft foot 926 and held in position
with a tie 909. The graft foot 926 contains suture channels 972 for
releasably retaining sutures 974. The sutures 974 extend from the
graft foot through suture grooves 984. The suture channels 972 are
positioned in an axial position relative to the longitudinal axis
along the graft shaft 928. As a result, the needles 956 carried by
the needle carrier 924 must also retrieve the sutures 972 in an
axial position The needles 956 are deployed radially inwardly
through the graft 900 in a regularly spaced pattern of penetration
sites or ports in the graft.
[0161] FIG. 36 specifically illustrates the details of the graft
suturing device that permits an inward radial deployment of the
needles 956. The graft suturing device 910 further includes an
outer cam 902 which deploys as a sleeve around the needle carrier
924 and needles 956. The cam 902 includes ridges 904 and troughs
906 along a surface 908 of the interior circumference of the cam.
The cam 902 is rotated about the longitudinal axis along the graft
shaft 928 in either a clockwise or counterclockwise direction as
indicated by arrows 988. Each of the needles 956 includes a tail
990 which abuts and slides along the interior surface 908. The
rotation of the cam 902 moves each of the needles 956 in either an
inward or outward direction as the tail 990 encounters either the
ridges 904 or troughs 906 respectively. The needles 956 are driven
inwardly through the graft 900 to engage the sutures 974. Then the
direction of the needles' movement is reversed and the needles 956
move outwardly from the graft 900 with the sutures 974 in tow. The
return of the needles 956 to their initial position is assisted by
a spring 992 coiled around the needles shaft. Subsequently, the
sutures 974 can be released from the needles 956 and the graft 900
can be removed from the cam 902 and graft foot 926.
[0162] As illustrated in FIG. 36, the needles 956 move
simultaneously inward. In another embodiment, the needles can move
inward successively by changing the position of the ridges 904 and
troughs 906 relative to each one another.
[0163] Other embodiments of the cam 902 provide means for moving
the needles 956 outwardly without using a spring-like member. For
example, FIG. 37 illustrates using a rail 994 to which the tail 990
of one of the needles is rotatably secured. As the cam 902 rotates
in the direction of the arrows 988 and slides along the rail 994,
the needle 956 is moved inward and then is positively moved outward
as the cam advanced. In a similar example, the interior surface 908
can include the rail to which the tail 990 of the needle is
slidably attached. As the cam 902 is rotated, the tail 990 slides
along the rail from trough 906 to ridge 904 and vice versa Since
the tail 990 is positively attached to the interior surface 908,
the needle moves outward without the assistance of a spring-like
member.
[0164] Referring to FIG. 31, the graft suturing device 710 and the
tissue suturing device 610 can be used solely independent (one
without the other) or operating together simultaneously or
successively. The inventive tissue suturing device 610 and
inventive graft suturing device 710 described herein can also be
used solely independent with other devices or methods (conventional
or not) to perform the other device's function in anastomosis
assembly and method. For example, the graft suturing device 710
described in the related applications can be readily adapted to
interlock with the tissue suturing device 610 herein.
[0165] Preferably, the graft suturing device can be loaded with the
graft prior to the insertion and operation of the tissue suturing
device. The two devices are then combined into one assembly to
provide proper orientation of the graft to the deployed suture
pattern in the vessel wall. This results in a two-stroke method
being used wherein one needle passes the suture through the graft
and a second needle passes the suture through the vessel wall.
[0166] In another embodiment, a one-stroke method can be used with
the present invention. For example, using only the vessel suturing
device, the needles can first pass the suture through the proximal
side of the graft before they are attached to the distal Mend of
the vessel suturing device. Then, as described above, the vessel
suturing device is inserted through the vessel wall. The suture can
then be passed through the distal side of the vessel wall to
complete the loop.
[0167] The present invention also provides a tissue suturing device
and an anastomosis assembly which inserts a portion of the tissue
suturing device from a remote access site other than the site of
the tissue suturing or anastomosis. Several embodiments of the
tissue suturing and/or graft anastomosis assembly which uses a
remote access site are illustrated in FIGS. 38-40.
[0168] FIGS. 38 and 40 illustrate a remote access site 1000 in the
tissue wall 1012 of a blood vessel 1014. A remote foot 1026 is
introduced into the blood vessel 1014 through the remote access
site 1000. The remote foot 1026 is attached near its heel end wall
1002 to a guide wire 1004 which is controlled at the other end by
an actuating mechanism 1030.
[0169] The remote foot 1026 has a top surface 1060 with a groove
1064 thereon for facing the distal end of a needle carrier and
corresponding to the position of a cutting blade as discussed
herein. Located near the circumference 1070 of the top surface 1060
is a plurality of suture channels 1072 extending into the foot
1026. The pattern of the suture channels 1072 on the top surface
1060 corresponds to the pattern of needles on the distal end of the
needle carrier that will be attached to the remote foot 1026 at the
site where the suture pattern is desired. Each of the suture
channels 1072 in the remote foot are sized to releasably retain a
suture 1074 having a suture body or length 1078 terminating at one
end 1076. Preferably, the end 1076 of the suture is releasably
retained in one of the suture channels 1072.
[0170] The sutures lengths 1078 extend across the top surface 1060
of the remote foot and to terminate at the bottom of a plug 1006.
The plug 1006 releasably retains the ends 1094 of the sutures 1074
opposite the suture ends 1076 retained in the suture channels 1072
so the suture ends 1094 may be individually identified as to their
position in the suture pattern and retrieved by the operator. The
plug 1006 is detachable from the remote foot by the actuating
mechanism 1030. Once the remote foot 1026 has been guided to the
desired cite of the suture pattern, the plug 1006 is released from
the remote foot by the actuating mechanism 1030 and driven through
the tissue wall 1012 of the blood vessel by a releasable connection
to a second wire 1009 associated with the guide wires 1004 as seen
in FIG. 39. To assist in making an initial aperture 1052 through
the tissue layer 1012 for the plug 1006 to pass through, a dilating
blade 1008 is preferably mounted on the top surface of the plug.
The suture lengths 1078 have an excess amount of length sufficient
to allow the plug 1006 to be pulled free of the blood vessel 1014.
The excess amount of length is coiled within the remote foot 1026
beneath the bottom surface of the plug 1006 before the plug is
released. After the plug 1006 has passed through the tissue wall
1012, the opposite suture ends 1094 can be released.
[0171] With the release of the plug 1006, a depression 1098
corresponding to the shape of the plug is left in the top surface
1060 of the remote foot. This depression is adapted to securely
receive the distal end of a shaft of a tissue suturing device (not
shown) as previously described herein. The shaft is advanced
through the initial aperture 1052 into the depression 1098.
Attachment of the shaft of the tissue suturing device to the remote
foot 1026 provides proper alignment of the needle carrier and
needles of the tissue suturing device with the suture channels 1072
of the remote foot.
[0172] Optionally, the plug 1006 can be another embodiment of the
graft foot previously discussed herein. Referring to FIG. 39, the
plug 1006 includes suture channels 1096 for releasably retaining
the opposite suture ends 1094. The suture channels 1096 are
illustrated in an axial position relative to the longitudinal axis.
The plug 1006 can then be attached to the shaft or other
positioning device on a graft suturing device as previously
described herein specifically with regard to FIG. 35.
[0173] An alternate embodiment of the plug 1006 positions the
suture channels 1096 along the longitudinal axis so that suture
channels 1072 are flush with the top surface of the plug 1006. With
this configuration of suture channels 1072, the plug can be
attached to the shaft of a graft suturing device as previously
described herein specifically with regard to FIG. 31.
[0174] Another embodiment of a tissue suturing device and an
anastomosis assembly which inserts a portion of the tissue suturing
device from a remote access site other than the site of the tissue
suturing or anastomosis is illustrated in FIG. 40. The tissue
suturing device 1110 in this embodiment uses a needle carrier 1124,
a shaft 1128, and a remote foot 1126 as previously described with
regard to the embodiments of the non-remote tissue suturing device.
The remote foot 1126, however, is attached to a rigid extension
1102 which connects at the other end to the shaft 1128. Similarly,
the needle carrier 1124 is attached to a rigid extension 1104 which
connects at the other end to the shaft 1128. The extensions 1102
and 1104 allow the remote foot 1126 to be inserted through the
tissue layer 1112 into a blood vessel 1114 at a remote access site
1100. As previously described with regard to the various
embodiments of the tissue suturing devices, the needle carrier 1124
has a shape corresponding to the remote foot 1126 so that the
needles 1156 are aligned with the suture channels 1172.
[0175] The suture channels 1172 releasably retain sutures 1174 at
one of the ends 1176 while the suture lengths 1178 extend across
the top surface 1160 of the remote foot through suture grooves 1184
near the perimeter of the remote foot. The opposite ends 1194 of
the sutures terminate in a plug 1106 which is releasably retained
flush with the top surface 1160 of the remote foot. One of the
needles like 1157 on the needle carrier is aligned to retrieve the
plug 1106 and draw it through the tissue layer 1112. After the plug
1106 has been drawn through the tissue layer 1112, the opposite
ends 1194 of the sutures can be freed from the plug.
[0176] The tissue suturing device 1110 demonstrates that a suture
pattern can be deployed at a deployment site 1108 other than the
remote access site. Furthermore, the tissue suturing device 1110
does not need an initial aperture at the suture deployment site
1108 in order to deploy the suture pattern. The alignment between
the needles 1156 and the suture channels 1172 is provided by the
extensions 1102 and 1104 without a shaft extending through an
aperture at the deployment site 1108.
[0177] Optionally, a cutting blade 1146 can be mounted on the
needle carrier 1124 and is positioned to make an incision at the
deployment site 1108 to form an anastomosis site different from the
remote access site 1100 and not simply enlarge an initial insertion
site. The cutting blade 1146 is preferably aligned with the groove
1164 on the top surface 1160 of the remote foot and avoids contact
with the suture lengths 1178. Rather than drawing the plug 1106
through a separate port in the tissue layer 1112, the plug 1106 can
be drawn through the incision made by the cutting blade 1146.
[0178] With the various inventive embodiments, alternate means of
fastening the two ends of the suture body together are suitable.
For example and not for limitation, the two ends of the suture body
can be simply tied in a knot manually or, optionally, with a knot
device as is described in copending application U.S. Ser. No.
08/552,211 filed Nov. 2, 1995.
[0179] Even though the suture devices are illustrated herein with
regard to vascular tissue, it should be understood that the present
invention is riot limited to any particular type of tissue.
Generally, the devices of the present invention can be used for
suturing all types of tissue in many applications. More
specifically, the present invention can close apertures in tissue
or bind layers of tissue together such as in anastomoses. For
example, and not for limitation, the present invention can be used
to close apertures in the septum of the heart such as with a atrial
septal defect or a patent foramen ovale. The present invention can
deploy sutures around the annulus of a valve for the heart or other
organs and around the proximity of a prosthesis.
[0180] The present invention can be used in anastomoses to provide
a direct or indirect communication between two blood vessels,
lymphatics, hollow viscera, or other tubular structures. Although
the anastomoses between an aperture in a vessel wall and the end of
a graft is specifically illustrated, the present invention can also
be used to anastomose tubular structures in other configurations
such end-to-end, end-to-side, in continuity, conjoined, or
closed-end. Examples of specific applications include the CABG
methods described herein using vessels and tubular grafts such as
the aorta, veins, the internal mammary artery, or superficial
temporal artery. An example of an anastomosis involving an organ
instead of a blood vessel is a Roux-en-Y operation which implants
the distal end of the divided jejunum with the proximal end into
the side of the jejunum at a suitable distance below the first to
form a Y-shape pattern.
[0181] The suturing devices described herein, particularly the
tissue suturing devices, can be used on grafts which do not have an
open end. In some instances, the open end of a graft is closed off
by a clamp or other closure means. An incision is made in the graft
to allow penetration of the foot of the tissue suturing device of
the present invention into the side of the graft. The tissue
suturing device deploys the desired suture pattern and is withdrawn
from the graft. The suture pattern is available for attachment to a
corresponding suture pattern or other fastener arrangement. In an
anastomoses procedure, the corresponding suture pattern is deployed
on the selected vessel,
[0182] The present invention can be used with catheter-based
surgical techniques wherein one of the elements of the devices
described herein is delivered to the suture site through a remote
or alternate access location. For example, the vessel suturing
device described herein can be introduced to the aorta through the
femoral artery to the site where the sutures are deployed. The
present invention allows indirect visualization of the desired
deployment site via marker ports, crystals or the like.
[0183] While particular embodiments of the invention have been
herein described in detail, it is to be appreciated that the
present invention encompasses variations and combinations thereof,
as may be apparent to one of ordinary skill from this disclosure.
It is therefore to be understood that within the scope of the
appended claims, the invention may be practiced otherwise than as
specifically described herein.
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