U.S. patent application number 10/764837 was filed with the patent office on 2004-08-12 for apparatus and method for placing multiple sutures during anastomosis.
Invention is credited to Field, Frederic P., Rice, John T., Sancoff, Gregory E..
Application Number | 20040158267 10/764837 |
Document ID | / |
Family ID | 30117774 |
Filed Date | 2004-08-12 |
United States Patent
Application |
20040158267 |
Kind Code |
A1 |
Sancoff, Gregory E. ; et
al. |
August 12, 2004 |
apparatus and method for placing multiple sutures during
anastomosis
Abstract
An apparatus for placing multiple sutures during anastomosis of
physiological vessels includes a crown portion having a plurality
of strands connected together by one or more circular bands. The
strands each form a point at one end with a curved hook at the same
end. The curved hook acts as a suture to retain one or more of the
vessels. An alternative embodiment includes a plurality of strands,
or wires, that are inserted through one or more vessels to
simultaneously place multiple sutures. The present invention also
comprises a method for placing a plurality of sutures
simultaneously with an apparatus.
Inventors: |
Sancoff, Gregory E.; (North
Hampton, NH) ; Rice, John T.; (Lincoln, MA) ;
Field, Frederic P.; (North Hampton, NH) |
Correspondence
Address: |
Mark J. Pandiscio
Pandiscio & Pandiscio
470 Totten Pond Road
Waltham
MA
02154
US
|
Family ID: |
30117774 |
Appl. No.: |
10/764837 |
Filed: |
January 26, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10764837 |
Jan 26, 2004 |
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09705997 |
Nov 3, 2000 |
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6682540 |
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60163680 |
Nov 5, 1999 |
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Current U.S.
Class: |
606/153 |
Current CPC
Class: |
A61B 17/0644 20130101;
A61B 17/115 20130101; A61B 17/0643 20130101; A61B 17/11 20130101;
A61B 17/1285 20130101; A61B 2017/1107 20130101; A61B 2017/1135
20130101; A61B 2017/0641 20130101 |
Class at
Publication: |
606/153 |
International
Class: |
A61B 017/08 |
Claims
What is claimed is:
1. An apparatus for placing multiple sutures during anastomosis of
physiological vessels, said apparatus comprising: a crown
comprising: a plurality of strands, each strand of said plurality
of strands having a first end and a second end, each said strand
having a first portion and a second portion adjacent said first end
and said second end, respectively; at least one circular band
joining together said plurality of strands adjacent said first
portion of each said wire strand; each said strand forming a point
in said second end; and each said strand forming a hook adjacent
said second portion for attachment to at least one physiological
vessel during anastomosis of physiological vessels.
2. The apparatus of claim 1 further comprising means for retaining
each said hook of said plurality of strands in a first position for
insertion of said second portion of said crown into at least one
physiological vessel.
3. The apparatus of claim 2 further comprising means for deploying
each said hook second portion from said first position to a second
position for securing each said hook to at least one physiological
vessel during anastomosis of vessels.
4. The apparatus of claim 3 wherein said retaining means is a
retaining ring.
5. The apparatus of claim 4 wherein said deploying means is removal
of said retaining ring.
6. The apparatus of claim 5 wherein said removal of said retaining
ring is accomplished by cutting said retaining ring.
7. The apparatus of claim 2 wherein said retaining means is an
articulating portion on said strand, wherein said articulating
portion allows said hook to be retained by positioning said hook
around said first end of said strand and deployed by disengaging
said hook from said strand.
8. A method for placing multiple sutures during anastomosis of
physiological vessels, said method comprising: providing a crown
comprising: a plurality of strands, each strand of said plurality
of strands having a first end and a second end, each said strand
having a first portion adjacent said first end and said second end,
respectively; at least one circular band joining together said
plurality of strands adjacent said first portion of each said
strand; and each said strand forming a hook adjacent said second
end with a point at said second end; attaching a first
physiological vessel to said crown; and attaching a second
physiological vessel to said crown such that said first
physiological vessel and said second physiological vessel are
substantially joined to one another.
9. An apparatus for placing multiple sutures during anastomosis of
physiological vessels, said apparatus comprising: a body containing
multiple suture wires; a mandrel having a die surface corresponding
to said multiple suture wires, wherein said body and mandrel are
positioned relative to a first physiological vessel and a second
physiological vessel such that at least a portion of said first
physiological vessel and at least a portion of said second
physiological vessel are positioned between said body and said
mandrel, said suture wires are forced from said body through said
at least a portion of said first physiological vessel, off said die
surface and through said at least a portion of said second
physiological vessel to form multiple sutures.
10. The apparatus of claim 9 further comprising means for removing
said body from said first vessel and said second vessel.
11. The apparatus of claim 10 wherein said body removing means is a
hinged opening.
12. The apparatus of claim 9 further comprising means for removing
said mandrel from said first vessel and said second vessel.
13. The apparatus of claim 12 wherein said mandrel is inflatable
and said mandrel removing means is a catheter connected to said
mandrel.
14. A method for placing multiple sutures during anastomosis of
physiological vessels, said method comprising: providing an
apparatus having a body containing multiple suture wires and a
mandrel having a die surface; positioning said apparatus relative
to a first physiological vessel and a second physiological vessel,
such that at least a portion of said first physiological vessel and
at least a portion of said second physiological vessel are
contained between said body and said mandrel; and placing multiple
sutures by forcing said multiple suture wires from said body
through said at least a portion of said first physiological vessel,
off said die surface of said mandrel, and through said at least a
portion of said second physiological vessel to form multiple
sutures.
15. The method of claim 14 further comprising the method step of
removing said body from said first physiological vessel and said
second physiological vessel.
16. The method of claim 14 further comprising the method step of
removing said mandrel from said first physiological vessel and said
second physiological vessel.
17. A method for placing multiple sutures during anastomosis of
physiological vessels, said method comprising: providing a crown
comprising: a plurality of strands, each strand of said plurality
of strands having a first end and a second end, each said strand
having a first portion adjacent said first end and said second end,
respectively; at least one circular band joining together said
plurality of strands adjacent said first portion of each said
strand; and each said strand forming a hook adjacent said second
end with a point at said second end; attaching a first
physiological vessel to said crown by placing said first vessel
within said crown and everting one end of said first vessel over
said hooks; and attaching a second physiological vessel to said
crown such that said first physiological vessel and said second
physiological vessel are substantially joined to one another.
Description
REFERENCE TO EARLIER APPLICATION
[0001] This application claims the benefit of pending U.S.
Provisional Patent Application Serial No. 60/163,680, filed Nov. 5,
1999 by Gregory E. Sancoff, John T. Rice and Frederic P. Field. The
aforementioned document is incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The invention generally relates to apparatus and methods for
surgery. More specifically, the invention relates to apparatus and
methods for the surgical formation of anastomosis of physiological
vessels.
BACKGROUND OF THE INVENTION
[0003] It is a common surgical procedure to join together two or
more surgical vessels such as intestines or blood vessels. The
three main types of connections include: end-to-end, end-to-side,
and side-to-side connections. As these structures often carry
fluid, the connections formed must be at least substantially
complete around the entire surface. Traditional means for
connecting together these structures include the use of sutures or
staples.
[0004] Placing sutures by hand around the circumference of a vessel
is often very difficult and cumbersome due to various factors.
These factors include space limitations at the typical surgical
site and attachment of the desired surgical vessel to or
containment within various other structures. Such limitations
impede manipulation and cause difficulty in accessing remote sides
of the desired surgical vessels.
[0005] Additionally, blood vessels such as the coronary arteries,
or those vessels used to form bypasses, are small in diameter and
have very thin walls. The thin walls cause these vessels to adopt a
collapsed configuration during-handling which causes difficulty in
handling and positioning the vessels.
[0006] An object of the invention is to provide an apparatus for
placing multiple sutures during anastomosis of physiological
vessels.
[0007] Another object of the invention is to provide a method for
placing multiple sutures during anastomosis of physiological
vessels.
SUMMARY OF THE INVENTION
[0008] An apparatus for placing multiple sutures during anastomosis
of physiological vessels includes a crown portion having a
plurality of strands connected together by one or more circular
bands. The strands each form a point at one end with a curved hook
at the same end. The curved hook acts as a suture to retain one or
more of the vessels.
[0009] An alternative embodiment includes a plurality of strands,
or wires, that are inserted through one or more vessels to
simultaneously place multiple sutures.
[0010] The present invention also comprises a method for placing a
plurality of sutures simultaneously with an apparatus.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIGS. 1A-1E illustrate an embodiment of a crown for placing
multiple sutures.
[0012] FIGS. 2A-2D illustrate a crown including a retaining
ring.
[0013] FIG. 3 illustrates a crown including a handle.
[0014] FIGS. 4A-4N illustrate various embodiments of an apparatus
for surgical anastomosis using an eversion technique.
[0015] FIGS. 5A-5C illustrate an internal version of a crown.
[0016] FIGS. 6A-6B, 7A-7B and 8A-8B illustrate various embodiments
of strands having structures for additional flexibility.
[0017] FIGS. 9-11 illustrate various eversion techniques using a
crown.
[0018] FIGS. 12A-12D illustrate a crown formed of a planar
material.
[0019] FIGS. 13A-13B illustrate a crown having a unitary ring
structure.
[0020] FIGS. 14A-14B illustrate an embodiment of the invention with
hooks at both ends of a crown.
[0021] FIGS. 15A-15B illustrate an embodiment of the invention with
a self-locking hook.
[0022] FIGS. 16-19 illustrate various pointed ends of a strand.
[0023] FIG. 20 illustrates an external version of a crown.
[0024] FIGS. 21A-21F illustrate a device that places and secures
sutures for making anastomotic connections.
[0025] FIGS. 22A-22D illustrate various wire end
configurations.
[0026] FIGS. 23A-23F illustrate various die surface embodiments of
a device that places and secures sutures for making anastomotic
connections.
[0027] FIGS. 24A-24B illustrate embodiments of a hinged device that
places and secures sutures for making anastomotic connections.
[0028] FIGS. 25A-25B illustrate an inflatable mandrel at the end of
a catheter for a device that places and secures sutures for making
anastomotic connections.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0029] Referring to FIGS. 1-3, an apparatus 10 is shown for
surgical formation of an anastomosis. In a preferred embodiment,
apparatus 10 includes a crown 15 with a plurality of strands 20
joined together by at least two rings 25. Each strand 20 is joined
to rings 25 adjacent a first end 30 and has a pointed barb 35 at a
second end 40. Strand 20 includes a curved portion 45 adjacent barb
35 and second end 40. Curved portion 45 may be in the form of a
hook.
[0030] Now looking at FIG. 2A, crown 15 is shown with a retaining
ring 50 for restraining hooks 45 of each strand 20. Retaining ring
50 allows positioning of second end 40 of crown 15 adjacent tissue
of physiological vessels. Removal of retaining ring 50 causes
deployment of hooks 45 which secure to one, or more, physiological
vessels.
[0031] FIGS. 3 and 4A-4N illustrate a method for surgical formation
of an anastomosis of vessels, referred to as an eversion
technique.
[0032] In FIG. 3, apparatus 10 is positioned over one end of a
physiological vessel 55 and a scope 60 positioned therethrough is
shown. A handle 56 attached to crown 15 is provided to manipulate
apparatus 10. Handle 56 contains a separation means 57 which
includes, but is not limited to, a prefabricated breaking
point.
[0033] In FIG. 4A, the progression of crown 15 up the length of
vessel 55 is shown. After crown 15 is positioned a suitable
distance along vessel 55, the end of vessel 55 is folded back and
impaled upon hooks 45 as shown in FIG. 4B. Next, crown 15
surrounding vessel 55 is positioned within physiological vessel 65
as shown in FIG. 4D and as shown in a cross-sectional view in FIG.
4E. Retaining ring 50 is shown in the cross-sectional view of FIG.
4E and is accessible to the outside of the apparatus 10. Retaining
ring 50 is removed by cutting therethrough. Alternatively,
retaining ring 50 may be removed from hooks 45 by other methods
such as repositioning to an area adjacent rings 25.
[0034] Now looking at FIGS. 4F and 4G, apparatus 10 is shown after
retaining ring 50 is removed and hooks 45 are driven through vessel
65. As shown in FIG. 4G, a gap 75 may be created between vessel 55
and vessel 65 during the eversion technique.
[0035] In one embodiment of the invention, a sealing ring 70 is
also used in conjunction with crown 15 to form apparatus 10, as
illustrated in FIGS. 4H-4K. Sealing ring 70 is formed of a
puncturable, implantable material such as an elastic material
including, but not limited to, plastic or elastomer.
[0036] Looking again at FIG. 4G, the gap 75 between vessel 55 and
vessel 65 created by the eversion technique is shown. In order to
eliminate gap 75, and protect hooks 45, sealing ring 70 is placed
onto crown 15 as shown in FIGS. 4H and 4I. Now looking at FIG. 4J,
it can be seen that the outer surface of sealing ring 70 contacts
vessel 55 and vessel 65 as sealing ring 70 is impaled onto pointed
barbs 35. This simultaneous contact eliminates any passageway
created by gap 75. Additionally, sealing ring 70 having an
appropriately sized cross-sectional radius can also contact crown
15 above hooks 45 in addition to vessel 55 and vessel 65 to provide
a more secure seal of gap 75.
[0037] Now looking at FIG. 4K, an alternative embodiment includes a
plurality of sutures 80, placed around apparatus 10 to close gap 75
between vessel 55 and vessel 65. Sealing ring 70 may also be used
as described above for protection of pointed barbs 35 in addition
to the placement of sutures 80 for closure of gap 75.
[0038] Referring to FIGS. 4L-4N, another preferred embodiment
including a clover leaf bender 82 to drive the ends of hooks 45
containing pointed barb 35 toward vessel 65 is shown. Clover leaf
bender 82 is formed with a series of protrusions 83 and recesses
84. As shown in FIG. 4L, clover leaf bender 82 is placed around
crown 15 after vessel 55 and vessel 65 are attached to one another.
Now looking at FIG. 4M, recesses 84 contain the outwardly extending
ends of hooks 45 with protrusions 83 therebetween. Next, clover
leaf bender 82 is rotated, as shown in FIG. 4N, to drive the ends
of hooks 45 radially and downwardly toward vessel 65. In one
embodiment of the invention, clover leaf bender 82 is turned to
drive the ends of hooks 45 substantially parallel to vessel 65 and
is then removed from crown 15. In another embodiment, clover leaf
bender 82 is turned only enough to deflect the outwardly extending
ends of hooks 45 and is left in contact with hooks 45. Clover leaf
bender 82 acts in a similar manner as sealing ring 70 when left in
attachment to crown 15.
[0039] FIGS. 5A-5C illustrate an alternative arrangement in which
crown 15 is placed within physiological vessel 55. As shown in FIG.
5A, lock ring 85 is provided to secure crown 15 within vessel 55
and hooks 45 are restrained by retaining ring 50 prior to insertion
into vessel 65. Now looking at FIG. 5B, first end 30 (shown in FIG.
5A) of crown 15 is shown inserted into vessel 55 with lock ring 85
securely fastened over vessel 55 between crown rings 25. Hooks 45
are still restrained by retaining ring 50 for insertion of second
end 40 (shown in FIG. 5A) of crown 15 into vessel 65. Referring to
FIG. 5C, second end 40 of crown 15 is shown during insertion into
vessel 65. Retaining ring 50 is removed, preferably by cutting, and
hooks 45 deploy to secure crown 15 to vessel 65 as described above.
In addition, other embodiments described herein, such as sealing
ring 70 and/or sutures 80, may be implemented to further seal
together vessel 55 and vessel 65.
[0040] Now looking at FIGS. 6A-6B, 7A-7B and 8A-8B, alternative
embodiments are shown which provide greater flexibility in strands
20 attaching hooks 45 to crown rings 25. In FIGS. 6A and 6B, an
embodiment is shown in which each of the strands 20 contains a bend
90 to provide additional flexibility. In FIGS. 7A and 7B, an
embodiment is shown in which each of strands 20 contains a spring
95 to provide additional flexibility. In FIGS. 8A and 8B, an
embodiment is shown in which each of strands 20 uses a spring
structure 100 for attachment to one of crown rings 25. Strand bend
90, strand spring 95 and spring structure 100 are advantageous in
that less force is required to position hooks 45 with retaining
ring 50 or with any other instrument. Strand bend 90, strand spring
95 and spring structure 100 also permit greater deflection without
material failure of strand 20 and to increase the force of hooks 45
to penetrate vessel 65.
[0041] Referring now to FIG. 9, vessel 55 and vessel 65 are shown
attached together using the eversion technique at an angle relative
to one another. In FIG. 10, vessel 55 and vessel 65 are shown being
attached together using the eversion technique in series with each
other. In FIG. 11, a view is shown looking from the inside of
vessel 65 attached to vessel 55 with hooks 45 about the perimeter
of the attachment.
[0042] Referring to FIGS. 12A-12D, an alternative embodiment of an
apparatus and method where crown 15 is stamped or etched from a
sheet of material 105 is shown. In FIG. 12A, sheet 105 is shown
intact before stamping or etching to create crown 15. Phantom lines
110 on sheet 105 depict the configuration of the stamping or
etching. Next, crown 15 is stamped or etched from sheet 105 to form
a planar crown 115 as shown in FIG. 12B. Planar crown has a first
end 120 and a second end 125 on opposing ends of crown rings 25 to
connect together strands 20. Planar crown 115 is rolled to connect
first end 120 to second end 125 to form crown 15, as shown in FIG.
12C. Crown 15 formed by planar crown 115 has substantially straight
strands 20. Then hooks 45 are formed as shown in FIG. 12D. In this
configuration, crown 15 is utilized as otherwise described
herein.
[0043] Now looking at FIGS. 13A and 13B, an alternative embodiment
is shown in which crown rings 25 of crown 15 are a unitary
structure 130. Crown 15 having unitary structure 130 is formed
either by one of the techniques described above, by molding a
single element or by using other known processes. Then hooks 45 are
formed as shown in FIG. 13B. Crown 15 is attached to at least one
vessel structure using the techniques described herein.
[0044] Referring to FIGS. 14A and 14B, an alternative embodiment of
crown 15 having hooks 45 at both first end 30 and at second end 40
is shown. As shown in FIG. 14B, vessel 55 is attached to hooks 45
at first end 30 and then vessel 65 is attached to hooks 45 at
second end 40 to complete the surgical anastomosis of the vessels.
Additionally, other embodiments and methods described herein may be
incorporated into this embodiment.
[0045] Now referring to FIGS. 15A and 15B, an alternative
embodiment to restrain hooks 45 containing pointed barbs 35 is
shown. Strands 20 each contain an articulating portion 132 which
allows the positioning of hook 45 around and the positioning of
barb 35 behind strand 20 toward first end 30 of crown 15. To deploy
hook 45, second end 40 of crown 15 is positioned within a vessel.
Next, hook 45 springs outward, penetrating vessel 65, and then it
is snapped back around strand 20, as shown in FIG. 15B, thus
capturing vessels 55 and 65.
[0046] Pointed barbs 35 include a range of structures including,
but not limited to, several embodiments shown in FIGS. 16-19. In
FIG. 16, pointed barb 20 is conically shaped at the end of a
cylindrical shaped strand 20. In FIG. 17, pointed barb 20 is formed
from a cut at an acute angle from a cylindrical shaped strand 20.
In FIG. 18, pointed barb 20 is formed from a pair of cuts at acute
angles at the end of a rectangular shaped strand 20. In FIG. 19,
pointed barb 20 is formed in a pyramidal shape at the end of a
rectangular shaped strand 20.
[0047] The preferred embodiment of the invention also includes
sealants to facilitate closure of gap 75, or any other opening.
Sealants are contained on crown 15 adjacent hooks 45. Sealants
include, but are not limited to, various glues and clotting agents.
After placement of crown 15 and effecting the surgical anastomosis,
these sealants further aid in closure of any gaps and openings.
[0048] An alternative embodiment of the invention, as shown in FIG.
20, includes an apparatus and method to place vessel 55 inside
crown 15 and to secure crown 15 with an internal lock ring 135
placed in vessel 55 at a position between two crown rings 25. Lock
ring 135 exerts an outward force to hold vessel 55 to crown 15.
[0049] FIGS. 21A-21F show another embodiment of an apparatus and
method to use metal suture wires to form an anastomotic connection
between vessel 55 and vessel 65. A flexible mandrel 140 with a
flanged end 145 is inserted into vessel 55 such that the end of
vessel 55 is flared against flanged end 145 of mandrel 140.
[0050] A main body section 150 is placed over vessel 55. Section
150 consists of a tubular section 155 with a flanged end 160 that
mates with that of flexible mandrel 140. Starting within flanged
end 160 of the main body, and extending along the axial length a
short distance, are wire tubes 165 that contain short pieces of
metallic wire 170. Above tubes 165 is a sleeve 175 that slides
along the outside of main body 150. Within the walls of sleeve 175
are receiving holes 180 for wire tubes 165, and plungers 185
extending from the receiving holes 180. Receiving holes 180, in
combination with wire tubes 165, form a telescoping tube pair 190
that supports wire 170 as the end of the sleeve side is advanced
forward. Sliding sleeve 175 toward flanged end 160 of main body 150
causes the plungers 185 to push wires 170 downward and into the
tissue of vessel 55. Wire 170 would normally buckle under the load,
but tubes 190 provide lateral support. When the tips of the wire
170 reach flanged end 145 of flexible mandrel 140, a die surface
195 (shown in FIG. 23B) deflects wire 170 outward and backward,
i.e. proximally. At this point the tips of wire 170 have pierced
the wall of vessel 55 and the wall of vessel 65 and, with the
deflection caused by die surface 195, will now go back up through
and out the wall of vessel 65 as sleeve 175 is advanced further.
Wire advance is stopped when the outer wire tube 190 hits the
bottom of receiving holes 180 of sleeve body 175. Main body 150 is
then pulled away from the suture site along the vessel axis,
allowing wires 170 to remain where they have been placed.
[0051] FIGS. 22A-22D show four possible end configurations for the
tip of wire 170 to maintain the approximation of the tissue. If
wire 170 is made of a very elastic material such as Nitinol, wire
170 can be preformed into these shapes and resume these shapes once
it has been pushed out of wire tubes 165. Wire 170, as shown in
FIGS. 22A, 22C, and 22D, holds the tissue in place because the
tissue would otherwise have to bend wire 170 to provide an exit
path. The distal end of wire 170, as shown in FIG. 22B, forms a
loop about a section of the proximal strand, or vice versa, thereby
creating an even more secure hold on the tissue.
[0052] In the case of malleable metallic suture wire 170, the
section of suture wires 170 that have passed through die surface
195 can be formed into various shapes depending on the geometry of
die surface 195. The smaller the radius of die surface 195, the
tighter the curvature of the end configuration of suture wire 170.
See FIGS. 23A-23F.
[0053] Because both main body 150 and sleeve 175 are circumscribing
vessel 55 after it has been sutured, a method to remove main body
150 and sleeve 170 after the sutures have been placed is provided.
Embodiments of main body 150 and sleeve 175 that have been split
lengthwise and hinged at one edge are shown in FIG. 24A. After wire
sutures 170 have been placed, sleeve 175 is opened up and pulled
away, followed by main body 150 in the same fashion.
[0054] Flexible mandrel 140 must also be removed once the
connection has been made. FIGS. 25A and 25B show flexible mandrel
140 that has an inflatable flanged end 200 with die surfaces 195
that expand with the inflation. The fluid pressure to expand
mandrel 140 comes from a catheter 210 that is also used to deliver
fluid from a point somewhere in the body or outside the body.
Because die surfaces 195 need to be rigid, die surfaces 195 are
placed on a separate surface 220 from flange 200 that can expand
but also remain rigid to deflect wire 170.
[0055] The present devices provide a means of placing and securing
wire sutures around the circumference of vessels during an
anastomosis.
* * * * *