Note: Descriptions are shown in the official language in which they were submitted.
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APPARATUS AND METHOD FOR PLACING MULTIPLE SUTURES
DURING ANASTOMOSIS
Reference To Earlier Application
This application claims the benefit of pending
U.S. Provisional Patent Application Serial No.
60/163,680, filed November 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
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
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,
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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.
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.
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.
An object of the invention is to provide an
apparatus for placing multiple sutures during
anastomosis of physiological vessels.
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Another object of the invention is to provide a
method for placing multiple sutures during anastomosis
of physiological vessels.
Summary Of The Invention
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.
Brief Description Of The Drawings
Figs. lA-lE illustrate an embodiment of a crown
for placing multiple sutures.
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Figs. 2A-2D illustrate a crown including a
retaining ring.
Fig. 3 illustrates a crown including a handle.
Figs. 4A-4N illustrate various embodiments of an
apparatus for surgical anastomosis using an eversion
technique.
Figs. 5A-5C illustrate an internal version of a
crown.
Figs. 6A-6B, 7A-7B and 8A-8B illustrate various
embodiments of strands having structures for additional
flexibility.
Figs. 9-11 illustrate various eversion techniques
using a crown.
Figs. 12A-12D illustrate a crown formed of a
planar material.
Figs. 13A-138 illustrate a crown having a unitary
ring structure.
Figs. 14A-14B illustrate an embodiment of the
invention with hooks at both ends of a crown.
Figs. 15A-15B illustrate an embodiment of the
invention with a self-locking hook.
Figs. 16-19 illustrate various pointed ends of a
strand.
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Fig. 20 illustrates an external version of a
crown.
Figs. 21A-21F illustrate a device that places and
secures sutures for making anastomotic connections.
Figs. 22A-22D illustrate various wire end
configurations.
Figs. 23A-23F illustrate various die surface
embodiments of a device that places and secures sutures
for making anastomotic connections.
Figs. 24A-24B illustrate embodiments of a hinged
device that places and secures sutures for making
anastomotic connections.
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
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
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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.
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.
Figs.. 3 and 4A-4N illustrate a method for surgical
formation of an anastomosis of vessels, referred to as
an eversion technique.
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.
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
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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.
Now looking at Figs. 4F arid 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.
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.
Looking again at Fig. 4G, the gap 75 between
vessel 55 and vessel 65 created by the eversion
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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.
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.
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
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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.
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
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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.
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
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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.
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.
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
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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.
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.
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
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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.
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.
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
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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.
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
anastomosi.s, these sealants further aid in closure of
any gaps and openings.
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.
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
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inserted into vessel 55 such that the end of vessel 55
is flared against flanged end 145 of mandrel 140.
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.
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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.
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.
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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.
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.
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
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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.
The present devices provide a means of placing and
securing wire sutures around the circumference of
vessels during an anastomosis.
