U.S. patent number RE37,107 [Application Number 09/299,449] was granted by the patent office on 2001-03-20 for device and method for the surgical anastomasis of tubular structures.
This patent grant is currently assigned to Surgical Innovations LLC. Invention is credited to David Wells-Roth.
United States Patent |
RE37,107 |
Wells-Roth |
March 20, 2001 |
Device and method for the surgical anastomasis of tubular
structures
Abstract
A device for assisting in anastomosis of tubular structures. The
basic device has a generally cylindrical shape with a pair of
insertion arms and a central depression that provides a space for
the needle to move through within the tubular structures while
simultaneously providing support so that the suture needle thrust
does not collapse the tubular structure wall. The depression may be
configured to guide the path of the needle. A bridge connects the
arms and prevents the needle from inadvertently coming in contact
with the wall opposite that of the wall being sutured. The method
includes an initial suture to join the sutures, inserting the
device into the openings of the two structures, placing sutures in
the walls adjacent to the depression, optionally rotating the
device so the depression is aligned with each suture as it is being
placed, removing the device, and tightening the sutures to complete
the anastomosis.
Inventors: |
Wells-Roth; David (Washington,
DC) |
Assignee: |
Surgical Innovations LLC
(Boston, MA)
|
Family
ID: |
22252463 |
Appl.
No.: |
09/299,449 |
Filed: |
April 26, 1999 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
Reissue of: |
095537 |
Jun 10, 1998 |
05868765 |
Feb 9, 1999 |
|
|
Current U.S.
Class: |
606/155;
606/153 |
Current CPC
Class: |
A61B
17/0482 (20130101); A61B 17/11 (20130101); A61B
2017/1135 (20130101) |
Current International
Class: |
A61B
17/11 (20060101); A61B 17/03 (20060101); A61B
17/04 (20060101); A61B 017/04 () |
Field of
Search: |
;606/153-156 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Jackson; Gary
Attorney, Agent or Firm: Morse, Altman & Martin
Claims
What is claimed is:
1. A device to aid in surgically joining a pair of tubular
structures at openings thereof, said device .[.consisting of.].
.Iadd.comprising.Iaddend.:
(a) a generally cylindrical body having a pair of opposed arms, a
bridge between said arms, and a depression between said arms;
(b) said arms having free extremities that are adapted for
insertion into said tubular structure openings;
(c) said depression being adapted to allow a suturing needle to
pass through a wall of each of said tubular structures; and
(d) said bridge being adapted to prevent trauma to said wall from
said needle opposite where said needle passes through said
wall.
2. The device of claim 1 wherein said extremities are convexly
rounded.
3. The device of claim 1 wherein said extremities are tapered.
4. The device of claim 1 wherein said arms are substantially the
same size.
5. The device of claim 1 wherein said arms are different sizes.
6. The device of claim 1 wherein said arms have a round
cross-section.
7. The device of claim 1 wherein said arms have an oval
cross-section.
8. The device of claim 1 wherein said arms have a C-shaped
cross-section to permit said device to be compressible.
9. The device of claim 1 wherein one of said arms has a maximum
cross-sectional area approximately that of the inside
cross-sectional area of one of said tubular structures and the
other of said arms has a maximum cross-sectional area approximately
that of the inside cross-sectional area of the other of said
tubular structures.
10. The device of claim 1 wherein said arms are solid.
11. The device of claim 1 wherein said arms include an axial
bore.
12. The device of claim 1 wherein said bridge is substantially
straight.
13. The device of claim 1 wherein said bridge is curved.
14. The device of claim 1 wherein said bridge is flexible.
15. The device of claim 1 wherein said depression is adapted to
place counter pressure on said tubular structure wall when said
needle is thrust through said wall in order to prevent said wall
from collapsing against pressure from said needle thrust.
16. The device of claim 1 wherein said depression is configured to
guide the path of said needle.
17. The device of claim 1 wherein said device is composed
substantially of a biologically inert material.
18. The device of claim 1 wherein said device is composed
substantially of a non-resorbable material.
19. The device of claim 1 wherein said device is composed
substantially of a resorbable material.
20. The device of claim 1 wherein at least a portion of said device
is radioopaque.
21. The device of claim 1 wherein at least a portion of said device
is magnetized.
22. The device of claim 1 wherein at least a portion of said device
includes at least one material selected from the group consisting
of an anticoagulant, an antibiotic, an antiseptic, a lubricant, and
a vascular spasm inhibitor.
23. The device of claim 1 wherein said device .[.is.]. includes a
structure for grasping.
24. A device to aid in surgically joining a pair of tubular
structures at openings thereof, said device .[.consisting of.].
.Iadd.comprising.Iaddend.:
(a) a generally cylindrical body having a pair of opposed arms, a
bridge between said arms, and a depression between said arms;
(b) said arms having free extremities that are adapted for
insertion into said tubular structure openings, one of said arms
having a maximum cross-sectional area approximately that of the
inside cross-sectional area of one of said tubular structures and
the other of said arms having a maximum cross-sectional area
approximately that of the inside cross-sectional area of the other
of said tubular structures;
(c) said depression being adapted to allow a suturing needle to
pass through a wall of each of said tubular structures; and
(d) said bridge being flexible and substantially straight and being
adapted to prevent trauma to said wall from said needle opposite
where said needle passes through said wall.
25. The device of claim 24 wherein said extremities are convexly
rounded.
26. The device of claim 24 wherein said extremities are
tapered.
27. The device of claim 24 wherein said arms are substantially the
same size.
28. The device of claim 24 wherein said arms are different
sizes.
29. The device of claim 24 wherein said arms have a round
cross-section.
30. The device of claim 24 wherein said arms have an oval
cross-section.
31. The device of claim 24 wherein said arms have a C-shaped
cross-section to permit said device to be compressible.
32. The device of claim 24 wherein said arms are solid.
33. The device of claim 24 wherein said arms include an axial
bore.
34. The device of claim 24 wherein said depression is adapted to
place counter pressure on said tubular structure wall when said
needle is thrust through said wall in order to prevent said wall
from collapsing against pressure from said needle thrust.
35. The device of claim 24 wherein said depression is configured to
guide the path of said needle.
36. The device of claim 24 wherein at least a portion of said
device includes at least one material selected from the group
consisting of an anticoagulant, an antibiotic, an antiseptic, a
lubricant, and a vascular spasm inhibitor.
37. The device of claim 24 wherein said device .[.is.]. includes a
structure for grasping.
38. A method for surgically joining a pair of tubular structures at
openings thereof, said method comprising the steps of:
(a) providing a device with a generally cylindrical body having a
pair of opposed arms, a bridge between said arms, and a depression
between said arms, said arms having free extremities that are
adapted for insertion into said tubular structure openings, said
depression being adapted to allow a suturing needle to pass through
a wall of each of said tubular structures, and said bridge being
adapted to prevent trauma to said wall from said needle opposite
where said needle passes through said wall;
(b) placing a single suture at said tubular structure openings to
hold said tubular structures together at a single point;
(c) inserting said device arm extremities into said tubular
structure openings;
(d) positioning said device in a working position such that said
depression straddles said tubular structure openings;
(e) introducing sutures into said tubular structure walls at suture
positions adjacent to said depression for permitting the suturing
needle to traverse through said walls;
(f) removing said device; and
(g) tightening said sutures.
39. The method of claim 38 wherein inserting and positioning said
device includes inserting said device substantially fully into a
first of said tubular structures, aligning said openings, and
sliding said device into a second of said tubular structures until
said device is in said working position.
40. The method of claim 38 wherein inserting said device includes
the use of a grasping tool.
41. The method of claim 38 wherein said device is rotated prior to
introducing each of said sutures such that said depression is
aligned with said suture position.
42. The method of claim 38 wherein said bridge is flexible and
removing said device includes bending said device at said bridge
such that said bridge extends outwardly through said sutures.
43. The method of claim 38 wherein removing said device includes
the use of a grasping tool.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a device and method for surgically
joining severed small tubular structures.
2. The Prior Art
It is presently possible to surgically join small tubular
structures, for example, severed arteries smaller than 5.0
millimeters (mm) in size, and even less than 1.0 mm in size.
However, considerable surgical dexterity is required. If
reunification of a patent conduit with normal or nearly normal flow
is to be achieved, great pains must be taken to insure gentle
handling of delicate tissues, particularly avoiding unnecessary
stretching, crushing, or piercing of the tissues. Such trauma
increases the likelihood of thrombosis and/or structural
failure.
Anastomosis of small tubular structures is preferably performed
under a microscope to aid in visualization. In the case of
end-to-end anastomosis, the severed vessels are gently clamped so
as to interrupt flow and to make the ends available for suture. An
initial suture is installed to connect the ends together at a
single point. This initial suture is usually positioned at the
anatomically deepest aspect of the anastomosis, a position which is
generally referred to as the "back wall" or "posterior wall" of the
anastomosis. Additional sutures are then placed to join additional
points of the separated ends.
A number of factors contribute to the difficulty of performing this
procedure:
(a) Loss of configuration. When tubular structures, such as blood
vessels, are emptied of their pressurized contents (such as blood),
the tubular lumen collapses and the tubular shape is lost. The ends
of such severed, collapsed structures are difficult to visualize in
their previously intact configuration or their preferably restored
configuration. They are also difficult to grasp and manipulate in
order to suture.
(b) Trauma from instrumentation. In placing sutures through the
vessel wall, the suture needle is passed through the wall either
from outside to in or from inside to out. To facilitate passing a
suture needle inward towards the lumen, an instrument, such as a
small forceps, is typically inserted into the lumen in order to
provide counter pressure to the thrust of the suturing needle, as
well as to attempt to separate the wall being sutured from the wall
behind it. Alternatively, the surgeon may be required to grasp the
full thickness of the wall being sutured with a forceps in order to
position it so that it may be pierced by the suturing needle. This
requirement for forceps to grasp and manipulate the dissociated
structures introduces an unwanted element of tissue trauma.
(c) Inadvertent misplacement of sutures. With tubular shapes,
especially those of small diameter, the opposite wall from the
point being sutured might be inadvertently pierced or traversed in
the line of the thrust of the suturing needle, especially in
placing sutures through the vessel wall from outside to in, toward
the lumen. This is especially so because of the lumen being
collapsed. Not only might tissues of the opposing wall be
traumatized, but the lumen may be inadvertently sutures shut. The
conventional use of a forceps either to exert counter-pressure on
the vessel wall for counter pressure for the suture needle thrust,
or to grasp the wall, does not fully protect the opposite wall from
inadvertently being caught in the suture or traumatized by the
suture needle.
(d) Spasm of the vessel. Trauma to the vessel may cause it to
spasm, adding a complicating factor in performing these
procedures.
(e) Time for performance. The present methods of performing
anastomoses are time consuming. Surgical risk, particularly
anesthetic risk, is known to be increased with time.
(f) Operator fatigue. The intense concentration, effort and time
required by the present methods contribute to frustration and
fatigue.
SUMMARY OF THE INVENTION
An object of the present invention is to provide a device and
method for surgically joining severed small tubular structures that
minimizes the problems associated with methods of the prior art. It
renders the process less technically demanding, decreases tissue
trauma associated with grasping and manipulating tissues,
diminishes the occurrence of inadvertent piercing trauma in the
line of suture needle thrust, facilitates speed, and decreases
operator fatigue.
The basic device of the present invention has a generally
cylindrical shape that includes a pair of insertion arms and a
central depression. The depression leaves a bridge connecting the
arms. The arms have free extremities that are preferably convexly
rounded or tapered for ease in inserting the device into the
tubular structure. The arms are smooth, coated with a lubricant,
and/or composed of a material that retains moisture for ease in
insertion. The lengths and/or cross-sections may be the same or
different between the two arms as may be needed for particular
applications. The cross-section may be round, oval, or such other
desired shape. The arms may be solid or may include an axial bore.
The arms are preferably constructed of a relatively firm material
that is biologically compatible.
The depression provides a space for the needle to move through
within the tubular structures while simultaneously the edge of the
depression provides support so that the needle thrust does not
collapse the wall. The depression may be configured to guide the
path of the suture needle.
The configuration of the depression generally determines the
configuration of the bridge, with some possible variations. For
example, the bridge may be straight or curved, depending upon the
desired final shape of the anastomosis. It may have a different
cross-section than that of the arms.
Along with connecting the arms, one purpose of the bridge is to
prevent the needle from inadvertently coming in contact with the
wall opposite that of the wall being sutured. Preferably, the
bridge is composed of a material that is difficult for the needle
to penetrate and that is relatively flexible so that the device can
be more easily removed from the tubular structures when no longer
needed.
Examples of suitable materials for the device include
polypropylene, dacron polyester, nylon, Teflon and
polytetra-fluoroethylene (PTFE). Where resorbtion might be desired,
the polyglycolic materials Vicryl and Dexon are suitable. The
present invention also contemplates that the colors of the device
may be vary depending upon a particular application. Optionally,
the material of the device is radioopaque, in whole or in part, for
the purpose of locating the device radiologically. Optionally, the
material of the device is magnetized, in whole or in part, for the
purpose of locating the device if lost in the surgical field.
The present invention also contemplates that the device contain or
be coated with additional materials to accomplish supplemental
objectives, such as clot prevention, spasm prevention and infection
prevention.
Optionally, the device includes a means for being inserted and
removed and/or manually rotated while residing in the tubular
structure. One such means includes a grasping ridge within the
bridge and a grasping tool configured to the shape of the ridge. A
second such means includes an axial concavity in each arm into
which feet of a grasping tool are inserted.
In the method of the present invention, that of an anastomosis of
tubular structures, the first step is to put an initial suture on
the back wall of the anastomosis. Then the device is inserted into
the openings of the two structures by either inserting the device
completely into one structure and sliding back into the other until
in the working position, or by folding the device at the bridge,
inserting each arm into the openings of the tubular structures, and
allowing the device to straighten out into the working position. In
the working position, the depression straddles the openings of the
tubular structures. Next, the needle pierces one wall adjacent to
the depression. Optionally, the edge of the depression is designed
to exert a counter pressure to the wall so that the thrust of the
needle does not collapse the wall. The depression provides enough
space for the needle to pass perpendicularly through the wall and
the bridge prevents the needle from contacting the opposite wall.
Sutures, of either the individual or continuous type, are placed
where necessary. The device may be rotated so that each new suture
is centered in the depression to provide maximum protection to the
structures walls. After the sutures are placed, the device is
either flexed at the bridge and removed or, if the sutures are
loose enough, slid completely into one of the structures and back
out through the sutures. Finally, the sutures are closed to
complete the anastomosis.
While the example cited relates to end-to-end anastomoses, the same
principles apply to end-to-end anastomoses as well. The same
principles apply equally well to all types of tubular structures,
for example, to vascular structures, to tubular structures of the
biliary tree, urologic, and reproductive systems, and to the
joining of synthetic grafts to tissues.
Other objects of the present invention will become apparent in
light of the following drawings and detailed description of the
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
For a fuller understanding of the nature and object of the present
invention, reference is made to the accompanying drawings,
wherein:
FIG. 1 is a side, perspective view of the basic embodiment of the
device of the present invention;
FIG. 2 is a top view of the embodiment of FIG. 1;
FIG. 3 is a side view of device of the present invention with
tapered extremities;
FIG. 4 is a side view of device of the present invention with arms
of different lengths;
FIG. 5 is an end cross-sectional view of device of the present
invention with a round cross-section;
FIG. 6 is an end cross-sectional view of device of the present
invention with an oval cross-section;
FIG. 7 is an end cross-sectional view of device of the present
invention with a compressible C-shaped cross-section;
FIG. 8 is an end view of device of the present invention with an
axial bore;
FIG. 9 is a side view of device of the present invention with a
curved bridge;
FIG. 10 is a side view of one configuration for manual rotation of
the device;
FIG. 11 is an end cross-sectional view of the configuration of FIG.
10;
FIG. 12 is a side cross-sectional view of another configuration for
manual rotation of the device;
FIG. 13 shows the first step of an end-to-end anastomosis of the
method of the present invention;
FIG. 14 shows the first step of an end-to-side anastomosis of the
method of the present invention; and
FIGS. 15-20 illustrates the remaining steps of the method of the
present invention.
DETAILED DESCRIPTION
The basic embodiment 10 of the device of the present invention is
illustrated in FIGS. 1 and 2. The basic device 10 has a generally
cylindrical shape. The components of the basic device 10 include a
pair of insertion arms 12 and a central depression 14. The
depression 14 leaves a bridge 16 connecting the arms 12.
The insertion arms 12 are designed to be non-traumatic when in
contact with the inside of the tubular structure. This is
accomplished by either making the outer surface of the arms 12
smooth, by forming the arms 12 of a material that retains moisture,
and/or by coating the arms 12 with a lubricant. As an aid to
insertion, the free extremities 20 of the arms 12 are convexly
rounded. Optionally, the free extremities are tapered, as at 22 in
FIG. 3. A tapered extremity is easier to insert because the tubular
structure, which is collapsed when empty, does not have to be
opened as far to start the insertion process.
The arms 12 may have the same or different lengths, as in FIG. 4,
and/or the same or different cross-sections, as in FIGS. 5-7, as
may be needed for particular applications. The cross-sectional area
is approximately that of the tubular structure so that it will
support the structure without stretching it. The cross-section may
be round, as in FIG. 5, oval, as in FIG. 6, or such other desired
shape. For example, the C-shaped cross-section of FIG. 7 would
allow narrowing by compressing the device at the edges 26 to
facilitate insertion. The arms 12 may be solid or may include an
axial bore 24, as in FIG. 8. The diameter of the bore 24 is
determined by its function. If its function is merely to equalize
pressures, the bore diameter can be minimized. The arms 12 are
preferably constructed of relatively firm material. Preferably, the
arms 12 are constructed of a biologically compatible material.
The depression 14 permits the suture needle room to move through
the wall when passing from outside to inside, and allows space for
the suture needle positioned inside the wall to be passed outwardly
through the wall. The depth, length, and width of the depression 14
may vary depending upon the application. The depression 14 may be
configured and positioned so that its edge 18 places counter
pressure on the inside of the tubular structure wall so as to
oppose the thrust of the suture needle when passed from outside to
in. The depression 14 may be configured to guide the placing of
sutures and/or limit the path of the suture needle.
The configuration of the bridge 16 is generally determined by the
configuration of the depression 14. However, the detailed
configuration may be designed for the particular size and anatomy
of the structures to be joined. For example, the bottom surface 28
may be straight, as in FIG. 1, or curved, as in FIG. 9. It may have
a different cross-section than that of the arms 12. It is
preferable, but not essential, that the bridge 16 be composed of a
material which allows the bridge 16 some flexibility for bending.
Preferably, the arms 12 are not separable from the bridge 16, as
one function of the bridge 16 is to pull the arms 12 from the
tubular structure when suturing is complete.
A second function of the bridge 16 is to prevent needle contact
with the wall of the tubular structure opposite that of the wall
being sutured. In the process of suturing, when the suture needle
passes into the depression 14, the bridge 16 prevents the needle
from contact with the opposite wall. Accordingly, the bridge
material, in addition to its preferred flexibility, is preferably
made of a material and in a thickness which is difficult for the
suture needle to penetrate.
Examples of materials suitable for the device of the present
invention include, but are not limited to, polypropylene, dacron
polyester, nylon, Teflon and polytetra-flouroethylene (PTFE), which
are materials commonly used in surgery. Where resorbtion might be
desired, it may be desirable that the device to be composed of a
resorbable material, such as the polyglycolic material Vicryl and
Dexon. The present invention contemplates that, depending upon
application, the material of the device may be clear, opaque, or of
a particular color or combination of colors, in whole or in part,
to facilitate visualization. Optionally, the material of the device
is radioopaque, in whole or in part, for the purpose of locating
the device radiologically. Optionally, the material of the device
is magnetized, in whole or in part, for the purpose of locating the
device if lost in the surgical field.
The present invention also contemplates that it might be desirable
for device to contain or be coated with additional materials to
accomplish additional objectives. For example, the device might be
coated with heparin to prevent clotting, with xylocaine or
verapamil to prevent vascular spasm, and/or with an antibiotic or
antiseptic to prevent infection.
Optionally, the device 10 includes a means for being inserted,
removed and/or manually rotated while residing in the tubular
structure. One such means is illustrated in FIGS. 10 and 11, and
includes a grasping ridge 32 located within the bridge 16. The
ridge 32 may be grasped with a grasping tool 34, particularly one
congruously configured to the shape of the ridge 32. The tool 34
may be fitted with spring-like action, either as an independent
spring or by virtue of the materials from which it is made. Such
solutions for grasping devices are well known.
A second inserting, removing and/or manually rotating means is
illustrated in FIG. 12. Each arm 12 includes an axial concavity 38
which allows it to be held by a foot 42 of a grasping tool 40. When
used for rotating the device 10, the concavities 38 and feet 42 may
be keyed so that the tool 40 does not rotate within the concavities
38. Squeezing the tool 40 releases the device 10. Like above, the
tool 40 may be fitted with spring-like action, either as an
independent spring mechanism 44 or by virtue of the materials from
which it is made. Again, such solutions for grasping devices are
well known.
A third removal means includes a fixed tab that extends from the
device, preferably through the space between the tubular
structures. The device is removed by pulling the tab through the
sutures.
The method of the present invention can be used for both end-to-end
anastomoses of tubular structures, as shown in FIG. 13, and
end-to-side anastomoses of tubular structures, as shown in FIG. 14.
The sequence of steps of the present invention for an end-to-end
anastomosis is illustrated in the sequence of FIGS. 15-20. The
method applies equally to an end-to-side anastomosis. In FIGS. 13
and 14, two tubular structures 50 are shown, their form irregular
as a consequence of being severed and not being under internal
pressure. As the first step in performing an anastomosis, shown in
FIG. 15, an initial stitch 42 is placed to hold the two structures
50 together at one point. That point is generally on the back wall
54 of the anastomosis. The next step is to insert the device 10
into the openings 56 of the two structures 50. There are two
preferred ways to insert the device. In the first, the device 10 is
inserted completely into one of the tubular structures 50 and then
slid back into the other tubular structure 50 until the device 10
is in the working position. In the second, the device 10 is folded
at the bridge 16 and each arm 12 is inserted into the opening 56 of
one of the tubular structures 50. After the bending pressure is
removed, the device 10 straightens out into the working position,
illustrated in phantom in FIGS. 16 and 17. In the working position,
the depression 14 straddles the openings 56 of the tubular
structures 50.
FIGS. 16 and 17 also show the needle 60 having pierced the wall 64
of one tubular structures 50 from outside to in. One arm 12 of the
device 10 is situated adjacent to the insertion point 62 of the
needle 60, exerting counter pressure to the needle thrust. The
depression 14 allows room for the needle 60 to be passed
perpendicular through the wall 64. The bridge 16 blocks the needle
60 from piercing the opposite wall 66. In FIG. 18, all of the
sutures 68 are placed, either in a continuous suture, like a
spiral, or as individual, separate sutures. As the sutures 68 are
placed, the device 10 may be rotated so that the new suture 68 is
centered in the depression 14. This provides maximum protection to
the structure walls 64.
FIG. 19 illustrates the device 10 being flexed at the bridge 16 and
removed from the tubular structures openings 56 prior to closure of
the sutures 68. Alternatively, if the sutures 68 are loose enough,
the device 10 is slid completely into one of the tubular structures
50, the tubular structures 50 are bent about the initial stitch 52,
and the device 10 is slid out of the tubular structure opening 56.
Finally, as shown in FIG. 20, the sutures 68 are tightened to
complete the anastomosis.
While the above description relates to end-to-end anastomoses, the
same principles apply to end-to-side anastomoses as well. In this
instance, the two arms may be of differing configurations so as to
fit into the differently-configured tubular openings to be joined.
While examples have been cited relating to vessels of arterial,
venous, and lymphatic nature, the joining of tubular structures
other than vascular, for example, tubular structures of the biliary
tree, urologic and reproductive systems, and the joining of
synthetic grafts to tissues are within the scope of the
invention.
Thus it has been shown and described a device and method for
surgically joining tubular structures which satisfies the objects
set forth above.
Since certain changes may be made in the present disclosure without
departing from the scope of the present invention, it is intended
that all matter described in the foregoing specification and shown
in the accompanying drawings be interpreted as illustrative and not
in a limiting sense.
* * * * *