U.S. patent application number 13/106560 was filed with the patent office on 2012-11-15 for emergency vascular repair prosthesis.
Invention is credited to Kurt J. Tekulve, Elizabeth A. Theobald.
Application Number | 20120290072 13/106560 |
Document ID | / |
Family ID | 47142403 |
Filed Date | 2012-11-15 |
United States Patent
Application |
20120290072 |
Kind Code |
A1 |
Theobald; Elizabeth A. ; et
al. |
November 15, 2012 |
EMERGENCY VASCULAR REPAIR PROSTHESIS
Abstract
A prosthesis system for repair of a transected body vessel is
provided. The system can include first and second prostheses each
including a tubular graft body and a support structure. Each
prosthesis can be expandable between a compressed and an expanded
configuration. In the expanded configuration, outer surfaces of the
first and second prostheses can engage walls of the body vessel.
The system can include a sleeve member formable into a tubular
body. The first and second prostheses can be coupled to one another
at a joint to form a coupled prosthesis. The sleeve member can
receive the coupled prosthesis and cover the joint to inhibit
leakage therefrom. The prosthesis system can connect first and
second portions of the body vessel to permit blood flow
therethrough. The sleeve member can be discrete to the coupled
prosthesis or can have one end fixedly attached to the coupled
prosthesis.
Inventors: |
Theobald; Elizabeth A.;
(Bloomington, IN) ; Tekulve; Kurt J.;
(Ellettsville, IN) |
Family ID: |
47142403 |
Appl. No.: |
13/106560 |
Filed: |
May 12, 2011 |
Current U.S.
Class: |
623/1.15 |
Current CPC
Class: |
A61F 2/064 20130101;
A61F 2/06 20130101; A61F 2/82 20130101; A61F 2/07 20130101; A61F
2002/828 20130101; A61F 2002/826 20130101 |
Class at
Publication: |
623/1.15 |
International
Class: |
A61F 2/82 20060101
A61F002/82 |
Claims
1. A system to interconnect a first vessel portion and a second
vessel portion of a body vessel, the system comprising: a first
prosthesis comprising a substantially tubular graft body, a support
structure coupled to the graft body, a first end, a second end, and
a lumen extending between the first and second ends, the first
prosthesis being movable between a compressed configuration and an
expanded configuration, wherein, in the expanded configuration, the
first end of the first prosthesis is configured to engage the first
vessel portion; a second prosthesis comprising a substantially
tubular graft body, a support structure coupled to the graft body,
a first end, a second end, and a lumen extending between the first
and second ends, the second prosthesis being movable between a
compressed configuration and an expanded configuration, wherein, in
the expanded configuration, the first end of the second prosthesis
is configured to engage the second vessel portion; wherein the
second end of at least one of the first and second prostheses
comprises a coupling member configured to engage the second end of
the other of the first and second prostheses at a joint to form a
coupled prosthesis having a continuous flow path defined by the
lumens of the first and second prostheses in communication with one
another; and a sleeve member formable into a substantially tubular
body having a passageway extending therethrough to receive the
coupled prosthesis, wherein the sleeve member is configured to
sealably cover the joint to inhibit leakage from the joint of the
coupled prosthesis.
2. The system of claim 1, wherein the first end of each of the
first and second prostheses comprises an anchoring member
configured to attach to a vessel wall.
3. The system of claim 1, wherein the sleeve member further
comprises at least one cinching member configured to tighten the
sleeve member along the outer surface of the coupled
prosthesis.
4. The system of claim 3, wherein the at least one cinching member
comprises a first cinching member disposed circumferentially along
a first portion of the sleeve member and a second cinching member
disposed circumferentially along a second portion of the sleeve
member.
5. The system of claim 3, wherein the at least one cinching member
is threaded into the sleeve member.
6. The system of claim 1, wherein one of the first and second ends
of the sleeve member is fixedly attached to one of the first and
second prostheses, and the other of the first and second ends of
the sleeve member is a free end, the sleeve member being movable
between a delivery configuration where the sleeve member is
positioned away from the joint and a deployed configuration where
the sleeve member is positioned to cover the joint.
7. The system of claim 6, wherein the free end of the sleeve member
further comprises at least one cinching member configured to
tighten the sleeve member along the outer surface of the coupled
prosthesis.
8. The system of claim 1, further comprising a sealant disposed
between the sleeve member and the outer surface of the coupled
prosthesis.
9. The system of claim 1, wherein each of the first and second
prostheses is self-expandable.
10. The system of claim 1, wherein the coupling member of one of
the first and second prostheses comprises a projecting member
configured to interlock with the other of the first and second
prostheses.
11. The system of claim 1, wherein the first prosthesis comprises a
first coupling member and the second prosthesis comprises a second
coupling member, the first and second coupling members configured
to interlock with one another to form the coupled prosthesis.
12. An apparatus to connect a first vessel portion and a second
vessel portion, the apparatus comprising: a coupled prosthesis
comprising a first prosthesis portion and a second prosthesis
portion, each of the first and second prosthesis portions
comprising a substantially tubular graft body attached to a support
structure, a first end, a second end, and a lumen extending between
the first and second ends, the second end of one of the first and
second prosthesis portions having a coupling member interlocked
with the other of the first and second prosthesis portions at a
joint to form the coupled prosthesis, where each of the first and
second prosthesis portions is independently movable between a
compressed configuration and an expanded configuration, and, in the
expanded configuration, the first end of each of the first and
second prosthesis portions is adapted to engage the respective
first or second vessel portion; and a sleeve member formable into a
substantially tubular body and having a first sleeve end, a second
sleeve end, and a passageway extending therethrough to receive the
coupled prosthesis therein, wherein the sleeve member is configured
to sealably cover the joint to inhibit leakage from the joint of
the coupled prosthesis.
13. The apparatus of claim 12, wherein the sleeve member is movable
between a delivery configuration where the sleeve member receivably
engages the coupled prosthesis and is positioned away from the
joint, and a deployed configuration where the sleeve member is
positioned to cover the joint.
14. The apparatus of claim 12, wherein the first sleeve end is
fixedly attached to the coupled prosthesis and the second sleeve
end is a free end.
15. A method of interconnecting a first vessel portion and a second
vessel portion, the method comprising: introducing a first end of a
first prosthesis in a compressed configuration into a first vessel
portion such that a second end of the first prosthesis is exposed
external to the first vessel portion; expanding the first
prosthesis to an expanded configuration such that the first end of
the first prosthesis engages a wall of the first vessel portion;
introducing a first end of a second prosthesis in a compressed
configuration into a second vessel portion such that a second end
of the second prosthesis is exposed external to the second vessel
portion; expanding the second prosthesis to an expanded
configuration such that the first end of the second prosthesis
engages a wall of the second vessel portion; coupling the second
end of each of the first and second prostheses together at a joint
external to the first and second vessel portions to form a coupled
prosthesis; and covering the joint of the coupled prosthesis with a
sleeve member to inhibit leakage from the joint of the coupled
prosthesis.
16. The method of claim 15, wherein the second end of at least one
of the first and second prostheses further comprises at least one
coupling member configured to engage the other of the first and
second prostheses.
17. The method of claim 15, wherein the first end of each of the
first and second prostheses comprises at least one anchoring member
to anchor to a vessel wall when in the expanded configuration.
18. The method of claim 15, wherein at least one cinching member is
coupled to the sleeve member, and the method further comprises
tightening the at least one cinching member to sealably cinch the
sleeve member along an outer surface of the coupled prosthesis.
19. The method of claim 15, wherein the sleeve member further
comprises a first end fixedly attached to one of the first and
second prostheses and a second free end, wherein the covering step
further comprises moving the second free end of the sleeve member
to the other of the first and second prostheses to cover the joint
of the coupled prosthesis.
20. The method of claim 19, wherein the sleeve member further
comprises a cinching member disposed at the second free end of the
sleeve member, and the method further comprises tightening the
cinching member to sealably cinch the sleeve member along an outer
surface of the coupled prostheses.
Description
BACKGROUND
[0001] The present disclosure relates generally to medical devices
for emergency repair of body vessels. More particularly, it relates
to prosthesis systems used for connecting transected body vessels
and gaining hemostasis during open surgical emergency medical
procedures.
[0002] Trauma physicians frequently encounter patients having
traumatic injury to a body vessel, such as lacerated vessels or
even transected vessels, resulting from gunshots, knife wounds,
motor vehicle accidents, explosions, etc. Significant damage to a
body vessel may expose a patient to deleterious conditions such as
the loss of a limb, loss of function of a limb, increased risk of
stroke, impairment of neurological functions, and compartment
syndrome, among others. Particularly severe cases of vascular
injury and blood loss may even result in death. In such severe
situations, the immediate goal is to obtain hemostasis while
maintaining perfusion of adequate blood flow to critical organs,
such as the brain, liver, kidneys, and heart.
[0003] Examples of treatment that are commonly performed by trauma
physicians to treat body vessel injuries include the clamping of
the vessel with a hemostat, the use of a balloon tamponade, the
ligation of the damaged vessel at or near the site of injury, or
the insertion of one or more temporary shunts. However,
conventional surgical repair is generally difficult with such
actively bleeding, moribund patients. In many instances, there is
simply not enough time to repair the body vessel adequately by
re-approximating and suturing the body vessel. In many situations,
the trauma physician will simply insert a temporary shunt (such as
a Pruitt-Inahara Shunt) into the vessel. However, use of temporary
shunts has been linked to the formation of clots. This may require
returning the patient to the operating room for treatment and
removal of the clots, often within about 36 to 48 hours of the
original repair. Since shunts are generally placed as a temporary
measure to restore blood flow and stop excessive blood loss, the
shunt is typically removed when the patient has stabilized
(generally a few days later) by a specialized vascular surgeon.
After removal, the vascular surgeon will replace the shunt with a
vascular graft, such as a fabric graft that is sewn into place.
With respect to ligation, ligation of the damaged blood vessel may
result in muscle necrosis, loss of muscle function, or a potential
limb loss or death.
[0004] Due to the nature of the body vessel injury that may be
encountered, the insertion of shunts or ligation of a blood vessel,
for example, often requires that such treatments be rapidly
performed at great speed, and with a high degree of physician
skill. Such treatments may occupy an undue amount of time and
attention of the trauma physician at a time when other pressing
issues regarding the patient's treatment require immediate
attention. In addition, the level of particularized skill required
to address a vascular trauma may exceed that possessed by the
typical trauma physician. Particularly, traumatic episodes to the
vessel may require the skills of a physician specially trained to
address the particular vascular trauma, and to stabilize the
patient in the best manner possible under the circumstances of the
case.
[0005] Some open surgical techniques utilize sutures to affix
damaged tissue portions surrounding fittings that have been
deployed with the vessel, which requires the trauma physician to
take time to tie the sutures properly. Although in modern medicine
sutures can be tied in relatively rapid fashion, any step in a
repair process that occupies physician time in an emergency
situation is potentially problematic. In addition, the use of
sutures to affix the vessel to the fitting compresses the tissue of
the vessel against the fitting. Compression of tissue may increase
the risk of necrosis of the portion of the vessel tissue on the
side of the suture remote from the blood supply. When present,
necrosis of this portion of the vessel tissue may result in the
tissue separating at the point of the sutures. In this event, the
connection between the vessel and the fitting may eventually become
weakened and subject to failure. If the connection fails, the
device may disengage from the vessel. Therefore, efforts continue
to develop techniques that reduce the physician time required for
such techniques, so that this time can be spent on other
potentially life-saving measures, and the blood flow is more
quickly restored and damage caused by lack of blood flow is
minimized.
[0006] Trauma physicians generally find it difficult to manipulate
a prosthesis for insertion into a body vessel that has been
traumatically injured. For example, one difficulty arises from the
trauma physician trying to limit the size of the opening created
for gaining access to the injured vessel so that such opening
requiring healing is as small as possible. Another difficulty is
that the injured vessel can be anywhere in the body, having
different surrounding environments of bone structure, muscle
tissue, blood vessels, and the like, which makes such obstructions
difficult to predict in every situation and leaves the trauma
physician working with an even further limited access opening.
Another potential consideration is the amount of body vessel
removed during a transection. The goal would be to remove a portion
of the body vessel as small as possible. Yet, a small portion
removed from the vessel leaves such a small space between the two
vessel portions, thereby making it difficult to introduce the
prosthesis between the two vessel portions.
[0007] Thus, what is needed is a prosthesis for use in open
surgical repair of an injured body vessel, such as an artery or a
vein, (and in particular a transected vessel) during emergency
surgery. It would be desirable if such prosthesis is easy for a
trauma physician to use, and can be rapidly introduced into two
vessel portions of a transected vessel, thereby providing a conduit
for blood within the injured body vessel.
SUMMARY
[0008] Accordingly, a system is provided herein to address at least
some of the shortcomings of the prior art. The system can be used
to connect two vessel portions such as for open surgical repair of
a transected body vessel. In one example, the system can include a
first prosthesis and a second prosthesis, each having a first outer
end and a second inner end. Each of the prostheses may be discrete
and independently moveable between a compressed configuration and
an expanded configuration. Each prosthesis can include a
substantially tubular graft body and a support structure. A lumen
can extend through each prosthesis between the first and second
ends thereof. The first end of each of the first and second
prostheses, when in the expanded configuration, can engage a
respective first or second vessel portion of the body vessel. The
second end of at least one of the first and second prostheses can
include a coupling member to engage the second end of the other of
the first and second prostheses at a joint to form a coupled
prosthesis. The coupled prostheses can have a continuous flow path
defined by the lumens of the first and second prostheses in
communication with one another. The system further can include a
sleeve member. The sleeve member can include a tubular body and a
passageway extending therethrough to receive the coupled
prosthesis. The sleeve member can sealably cover the joint to
inhibit leakage therefrom.
[0009] In another example, an apparatus can be used to connect
first and second vessel portions. The apparatus can include a
coupled prosthesis. The coupled prosthesis can include first and
second prosthesis portions. Each prosthesis portion can include a
substantially tubular graft body attached to a support structure, a
first end, a second end, and a lumen extending between the first
and second ends. The second end of one of the first and second
prosthesis portions can include a coupling member interlocked with
the other of the first and second prosthesis portions at a joint to
form the coupled prosthesis. Each of the first and second
prosthesis portions may be independently movable between a
compressed configuration and an expanded configuration. The first
end of each of the first and second prosthesis portions may be
adapted to engage the first or second vessel portion, respectively.
The apparatus can include a sleeve member that can be formable into
a substantially tubular body. The sleeve member can have first and
second sleeve ends and a passageway extending longitudinally
therethrough to receive the coupled prosthesis. The sleeve member
can sealably cover the joint to inhibit leakage therefrom.
[0010] In yet another example, a method of connecting first and
second vessel portions of a body vessel is provided herein. A first
end of a first prosthesis in a compressed configuration can be
introduced into an end opening of the first vessel portion of the
body vessel. A second end of the first prosthesis can remain
exposed external to the first vessel portion. The first prosthesis
can be expanded to an expanded configuration to engage a vessel
wall of the first vessel portion. A first end of a second
prosthesis in a compressed configuration can be introduced into an
end opening of the second vessel portion of the body vessel. A
second end of the second prosthesis can remain exposed external to
the second vessel portion. The second prosthesis can be expanded to
an expanded configuration to engage a vessel wall of the second
vessel portion. The second ends of the first and second prostheses
can be coupled to one another at a joint to form a coupled
prosthesis. The joint may be positioned external to the first and
second vessel portions. The joint of the coupled prosthesis can be
covered with a sleeve member to inhibit leakage from the joint.
BRIEF DESCRIPTIONS OF THE DRAWINGS
[0011] FIGS. 1A-1B are perspective views of one example of a
prosthesis system.
[0012] FIGS. 2A-2C illustrate examples of coupling members.
[0013] FIG. 3 illustrates a flexible member threaded into a sleeve
material of a sleeve member.
[0014] FIGS. 4A-4C are perspective views of another example of a
prosthesis system.
[0015] FIGS. 5A-5H illustrate a method of connecting two body
vessel portions with one example of a prosthesis system.
DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERRED
EMBODIMENTS
[0016] For the purposes of promoting an understanding of the
principles of the present disclosure, reference will now be made to
the embodiments illustrated in the drawings, and specific language
will be used to describe the same. The prosthesis described herein
can be useful for repair of a body vessel, such as a blood vessel,
during an emergency open surgical procedure. This prosthesis can be
particularly useful for repair of a lacerated artery or vein during
emergency surgery, and particularly, to obtain hemostasis while
maintaining blood perfusion. Other applications for the prosthesis
will become readily apparent to one skilled in the art from the
detailed description.
[0017] FIGS. 1A-1B depict one embodiment of a prosthesis system 10
having a first prosthesis portion 20, a second prosthesis portion
40, and a sleeve member 60. In some embodiments, the first
prosthesis portion 20 and the second prosthesis portion 40 may be
identical to one another in all respects. In other embodiments, one
prosthesis portion may include features and/or elements that may be
distinct from those of the other prosthesis portion. Therefore, the
description herein will be confined to the first prosthesis portion
20 except where the features of the second prosthesis portion 40
differ from those of the first prosthesis portion. It will be
readily recognized by one skilled in the art that any description
of the first prosthesis portion 20 may apply equally to the second
prosthesis portion 40 unless such application is inconsistent with
this disclosure.
[0018] The first prosthesis portion 20 can have an outer first end
21 and an inner second end 22. The first prosthesis portion 20 can
include a generally tubular graft body 23 having an inner surface
24 and an outer surface 25. The inner surface 24 of the graft body
23 can define a passageway 26 extending longitudinally within the
first prosthesis portion 20. The first prosthesis portion 20
further can include a support structure 27 disposed on the inner
surface 24 and/or the outer surface 25 of the graft body 23. At
least one anchoring member 30 can be disposed along any portion of
the first prosthesis portion 20 between the first end 21 and the
second end 22. In one example, the anchoring member 30 can be
disposed closer to the first end than the second end, and may be
disposed at the first end 21. The anchoring member 30 can be
configured to engage an outer wall of a body vessel as further
described herein. The anchoring member 30 may include a plurality
of anchoring members disposed around the circumference of the
prosthesis. The anchoring member 30 can provide vessel fixation,
while avoiding adverse conditions associated with disturbing the
vasa vasorum and/or pressure induced necrosis of the medium
muscular arteries of the type that may result from tying ligatures
circumferentially around a connector or a vascular conduit. The
anchoring member can include various shaped member structures,
including barbs, fibers, bristles, or other protruding and
penetrating media, which can be attached to the graft body and/or
the support structure, and preferably integral with the support
structure.
[0019] The first prosthesis portion 20 further can include at least
one coupling member 31 disposed along any portion of the first
prosthesis portion 20 between the first end 21 and the second end
22. In one example, the coupling member 31 can be disposed closer
to the second end than the first end, and may be disposed at the
second end 22. The coupling member 31 can engage a segment of the
second prosthesis portion 40 as further described herein to
securely interlock the two prosthesis portions so that the portions
do not detach during blood flow therethrough.
[0020] In FIGS. 1A-1B, the second prosthesis portion 40 can have
first and second ends 41, 42 and a graft body 43 having an inner
surface 44 defining a passageway 46 and an outer surface 45. The
support structure 47 can be disposed on the inner surface 44 and/or
the outer surface 45 of the graft body 43. The second prosthesis
portion 40 further can include at least one anchoring member 50.
The coupling member 31 of the first prosthesis portion 20 can be
adapted to attach to the second prosthesis portion 40 itself.
Optionally, the coupling member 31 may attach to the support
structure 47 of the second prosthesis portion, or may attach to a
corresponding coupling member 51 of the second prosthesis portion.
Similarly, the coupling member 51 may be included on the second
prosthesis portion 40 and adapted to attach to the first prosthesis
portion 20. The coupling member 51 can be adapted to attach to the
first prosthesis portion 20, for example, by engaging and/or
receiving a portion of the first prosthesis portion.
[0021] In one example, a portion of the second end of one of the
first and second prosthesis portions may have a circumference sized
and shaped to slidably receive or to be slidably received within
the second end of the other prosthesis portion. The second ends of
the prosthesis portions may be frictionally engaged with one
another to securely couple the two prosthesis portions. In another
example, the coupling member 31 may be configured as a marker band
to crimp the first and second prosthesis portions 20, 40 to one
another. For example, the marker band may be a tubular member
adapted to receive the respective second ends of the first and
second prosthesis portions within a lumen extending within the
marker band. The marker band may be crimped by any means known in
the art to engage the first and second prosthesis portions, thereby
securing the prosthesis portions to one another.
[0022] In yet another example, the coupling member 31 may be
configured as a hook member or other type of outwardly projecting
curved and/or angled member to engage the second prosthesis portion
40. Various examples of projecting members suitable for coupling
are illustrated in FIGS. 2A-2C. For example, the coupling member 31
may include a projection 32 extending from the support structure 27
of the first prosthesis portion 20. The projection 32 may terminate
in a hook 33 as shown in FIGS. 2A-2B. In FIG. 2A, the support
structure 47 of the second prosthesis portion 40, such as an apex
formed by two struts, can form the coupling member 51 so that the
hook 33 engages the support structure 47 directly. Alternatively,
in FIG. 2B, the coupling member 51 of the second prosthesis portion
40 may include an eyelet 54, such as extending from an apex formed
by two struts, to receive the hook 33, thereby securing the
prosthesis portions to one another. FIG. 2C illustrates an example
where the coupling members 31 and 51 are complementary to one
another and form a mating relationship. For instance, the outwardly
projecting coupling member 31 may include a projecting key member
35, which is shown as a t-member. The key member 35 may engage a
keyed slot 56 of the second prosthesis portion 40, which is shaped
and sized to receive the t-member so that a mating relationship is
formed therebetween. The keyed slot 56 may be formed as part of the
support structure 47 of the second prosthesis portion 40 and is
configured to receive the key member 35. Other examples of
interlocking or mating relationships are contemplated. For example,
the coupling member 31 may be configured to threadably engage the
second prosthesis portion 40. To this end, the coupling members 31,
51 may be configured as a union type fitting as known in the art. A
threaded portion of each of the coupling members may be adapted to
threadably engage a union member, thereby securing the prosthesis
portions to one another.
[0023] Regardless of the specific configuration of the coupling
members, engagement between the prosthesis portions may be
achieved, for example, by use of an interlocking mechanical member
(e.g., a hook, clasp, latch, lock, threaded connector, or other
suitable interlocking member) and/or by use of a non-mechanical
member (e.g., magnetic clasp or other suitable electro-magnetic
member) or adhesives or other bonding agents. Examples of
structures that may be suitable for coupling the first and second
prosthesis portions to one another are described, for example, in
U.S. Pat. Nos. 7,241,300 to Sharkawy et al.; 4,705,039 to Sakaguchi
et al.; and 4,214,586 to Mericle; and U.S. Pat. App. Pub. Nos.
2007/0010833 to Tanaka and 2005/0113905 to Greenburg et al., each
of which is incorporated by reference herein in its entirety. The
coupling members also may be positioned axially inward of the outer
end of the respective prosthesis portions such that, when the first
and second prosthesis portions are coupled, the distance between
the respective bodies of the prosthesis portions may be minimized.
A person having ordinary skill in the art will appreciate that the
at least one coupling member may be omitted from either the first
or second prosthesis portion.
[0024] The first and second prosthesis portions 20, 40 can be
movable between a radially compressed, or delivery, configuration
and a radially expanded, or deployed, configuration. The prosthesis
portions may be balloon expandable; however, it is preferred that
the prosthesis portions are self-expandable. The first and second
prosthesis portions can have a size and shape suitable for at least
partial placement within a body vessel, such as an artery or a
vein, and most particularly, for placement at the site of a
vascular trauma. The first and second prosthesis portions may be
easily manipulated during delivery to a transected artery or vein
during emergency surgery, and particularly, to obtain hemostasis
while maintaining blood perfusion.
[0025] The graft bodies 23, 43 of the first and second prosthesis
portions can be formed from conventional materials well known in
the medical arts. For example, the graft bodies can be formed from
an expanded polytetrafluoroethylene (ePTFE),
polytetrafluoroethylene, silicone, polyurethane, polyamide (nylon),
as well as other flexible biocompatible materials. The graft bodies
also can be formed from known fabric graft materials such as woven
polyester such as DACRON.RTM. from Invista (Wichita, Kans.),
polyetherurethanes such as THORALON.RTM. from Thoratec Corporation
(Pleasanton, Calif.), or polyethylene such as an ultra-high
molecular weight polyethylene (UHMwPE) such as DYNEEMA.RTM. from
DSM Dyneema LLC (Stanley, N.C.). The graft bodies also may include
a bioremodelable material such as reconstituted or
naturally-derived collagenous materials, extracellular matrix
material (ECM), submucosa, renal capsule membrane, dermal collagen,
dura mater, pericardium, fascia lata, serosa, peritoneum or
basement membrane layers, or intestinal submucosa, including small
intestinal submucosa (SIS), stomach submucosa, urinary bladder
submucosa, and uterine submucosa. One non-limiting example of a
suitable remodelable material is SURGISIS.RTM. BIODESIGN.TM. from
Cook Medical (Bloomington, Ind.). Another suitable remodelable
material is the graft prosthesis material described in U.S. Pat.
No. 6,206,931 to Cook et al., which is incorporated herein by
reference in its entirety.
[0026] The support structures 27, 47 can be configured as stents
having any stent pattern known to one skilled in the art.
Non-limiting examples of stent patterns include the Z-STENT.RTM.
and ZILVER.RTM. stent, each available from Cook Medical
(Bloomington, Ind.). Each support structure can extend along any
portion of the respective prosthesis portion. Preferably, the
support structure can extend along a length of the respective
prosthesis portion between the first and second ends thereof. The
support structure can be attached to the graft body of the
respective prosthesis portion by sutures sewn therein, wire,
staples, clips, bonding agents, or other methods that may be used
to achieve a secure attachment to the graft body. The various
components of the support structure can be formed from any
biocompatible material known in the art. Non-limiting examples of
such materials include a biocompatible metal, such as stainless
steel (e.g., 316L SS), titanium, tantalum, nitinol or other shape
memory materials, or a high-strength polymer.
[0027] In FIGS. 1A-1B, the sleeve member 60, formable into a
generally tubular body 61, can be coupled to the inner ends of the
first and second prosthesis portions 20, 40. To this end, the
sleeve member can be formed integrally from a tubular member or can
be formed from a planar member that is wrapped and attached to
itself, such as sewn with sutures or bonded with an adhesive, in
the shape of a tube. The body 61 can have first and second ends 62,
64 having a first end opening 63 and a second end opening 65,
respectively. The sleeve member 60 further can have an inner
surface 66 and an outer surface 67. The inner surface 66 can define
a passageway 68 extending longitudinally within the sleeve member
60. The sleeve member 60 can facilitate the sealing around the
joint between the first and second prosthesis portions when coupled
to one another to inhibit potential leakage from the joint. The
sleeve member also can retain the interlocking engagement of the
coupling member(s) and the prosthesis portions.
[0028] The sleeve member 60 further can include at least one
cinching member coupled to the body 61 for tightening the sleeve
member around the first and/or second prosthesis portions 20, 40.
The cinching member may be formed of any suitable material known in
the art, including, but not limited to, a flexible biocompatible
material such as suture material. The cinching member can help
maintain a secure engagement between the sleeve member and the
coupled first and second prosthesis portions, especially along the
joint, to inhibit potential leakage from the joint.
[0029] FIGS. 1A-1B depict one or more cinching members, such as
first and second cinching members 69, 70 disposed, e.g.,
circumferentially along the first and second ends 62, 64,
respectively, of the sleeve member 60. In one example, the cinching
members 69, 70 can be configured to surround the outer surface 67
of the sleeve member 60 to sealably cinch the sleeve member 60
along the outer surfaces 25, 45 of the first and second prosthesis
portions 20, 40 as further described herein. In FIG. 3, the
cinching member 69 can be threaded or woven into the body 61 of the
sleeve member 60. The cinching member 70 may be threaded or woven
into the body 61 of the sleeve member 60 in similar fashion. Hence,
the cinching members can be tightened (e.g., like purse or draw
strings) to cinch the first and second ends 62, 64 of the sleeve
member 60 by causing the material of the body 61 to bunch up or to
fold along the cinching members.
[0030] The body 61 of the sleeve member 60 can be formed from
conventional materials well known in the medical arts as described
herein with reference to the graft bodies 23, 43. The body 61 may
be formed from the same or a different material than that used to
form the graft body 23 of the first prosthesis portion 20 and/or
the graft body 43 of the second prosthesis portion 40. The body 61
can be formed from a material sufficiently flexible so that the
sleeve member 60 can be rolled over itself, folded, or otherwise
configured to move between a delivery configuration and a deployed
configuration as further described herein. The passageway 68 of the
sleeve member 60 can be sized and shaped suitably to receive
therein the first and/or second prosthesis portions 20, 40 as
further described herein.
[0031] A coating of one or more therapeutic agents can be included
along a portion of the graft bodies, the support structures, and/or
the sleeve member. Therapeutic agents for use as biocompatible
coatings are well known in the art. Non-limiting examples of
suitable bio-active agents that may be applied to the vascular
conduit include thrombo-resistant agents, antibiotic agents,
anti-tumor agents, antiviral agents, anti-angiogenic agents,
angiogenic agents, anti-mitotic agents, anti-inflammatory agents,
angiostatin agents, endostatin agents, cell cycle regulating
agents, and/or genetic agents, including hormones such as estrogen,
their homologs, derivatives, fragments, pharmaceutical salts and
combinations thereof. Those skilled in the art will appreciate that
other bioactive agents may be applied for a particular use. The
bioactive agent can be incorporated into, or otherwise applied to,
portions of the prosthesis system 10 by any suitable method that
permits adequate retention of the agent material and the
effectiveness thereof for its intended purpose.
[0032] FIG. 1B illustrates a coupled prosthesis 80 formed by
coupling the first and second prosthesis portions 20, 40 to one
another with the coupling member 31 and/or 51 at a joint 81. The
first and second prosthesis portions 20, 40 may be arranged in an
end-to-end relationship with one another and may be in abutting
contact with one another at the joint 81 to form the coupled
prosthesis 80. The coupled prosthesis 80 can be received within the
passageway 68 of the sleeve member 60. When the first and second
prosthesis portions 20, 40 are in the radially expanded, or
deployed configurations, the inner surface 66 of the sleeve member
60 can engage the outer surfaces 25, 45 at the inner ends 22, 42 of
the first and second prosthesis portions such that an intermediate
portion of the sleeve member 60 covers the joint 81 of the coupled
prosthesis 80. The cinching members 69, 70 can be tightened to
cinch the first and second ends 62, 64 of the sleeve member 60
around the prosthesis portions to inhibit leakage from the joint
81.
[0033] FIGS. 4A-4C depict another embodiment of a prosthesis system
110. In FIG. 4A, the first prosthesis portion 120 with the coupling
member 131 is decoupled from the second prosthesis portion 140. One
of the ends of the sleeve member 160 can be fixedly attached to one
of the prosthesis portions, such as the second prosthesis portion
140, at any point along a length of the prosthesis portion. The
other end of the sleeve member 160 may remain free to allow the
sleeve member to move between a delivery configuration and a
deployed configuration to engage the other prosthesis portion such
as the first prosthesis portion 120, as further described herein.
For example, a second end 164 of the sleeve member 160 can be
fixedly attached to the second prosthesis portion 140. The inner
surface 166 of the sleeve member 160 can engage the outer surface
145 of the second prosthesis portion 140 at the second end 142
thereof. The sleeve member 160 can be attached to the second
prosthesis portion 140 by any suitable attachment mechanisms such
as sutures sewn therein, wire, staples, clips, bonding agents, or
other methods that may be used to achieve a secure attachment. In
another example, the sleeve member 160 can be an extension of the
graft body of one of the prosthesis portions to extend beyond the
inner end of the prosthesis portion. In other words, the sleeve
material can be formed integrally with the graft body of the
prosthesis portion. When the sleeve member is an extension of the
graft body, the delivery profile may be reduced in comparison to
the configuration with the discretely attached sleeve member.
[0034] The sleeve member 160 can be movable between the delivery
configuration and the deployed configuration. FIGS. 4A-4B
illustrate the prosthesis system 110 with the sleeve member 160 in
the delivery configuration. In the delivery configuration, the
sleeve member 160 can be disposed away from the inner end 142,
e.g., toward the outer end 143 of the second prosthesis portion 140
so that the inner end is exposed for coupling to the coupling
member 131 of the first prosthesis portion 120. In other words, the
sleeve member 160 may be disposed such that it does not extend
beyond the inner end 142 of the second prosthesis portion 140. The
sleeve member 160 can be positioned in the delivery configuration
by various means such as being rolled back, folded (e.g., like an
accordion), scrunched, crumpled, or otherwise configured such that
the inner end 142 of the second prosthesis portion 140 can remain
uncovered and accessible for coupling between the first prosthesis
portion 120 and the second prosthesis portion 140 as described
herein. In one example, the sleeve member 160 can be rolled back or
everted around the second prosthesis portion 140 as shown in FIGS.
4A-4B so that a portion of the outer surface 167 of the sleeve
member is disposed adjacent to and/or in abutting contact with the
outer surface 145 of the second prosthesis portion 140.
[0035] FIG. 4B depicts the first prosthesis portion 120, with the
coupling member 131, coupled to the second prosthesis portion 140
to form the coupled prosthesis 180. The sleeve member may remain in
the delivery configuration following coupling.
[0036] FIG. 4C illustrates the prosthesis system 110 with the
sleeve member 160 in the deployed configuration. In the deployed
configuration, an inner surface 166 of the sleeve member 160 can
engage the outer surface 125 of the first prosthesis portion 120
and the outer surface 145 of the second prosthesis portion 140 such
that the intermediate portion of the sleeve member 160 covers the
joint 181 of the coupled prosthesis 180. A first cinching member
169 can be tightened to cinch the first end 162 of the sleeve
member 160 around the first prosthesis portion 120 to inhibit
leakage from the joint 181. A second cinching member (not shown)
also can be included and tightened to cinch another portion such as
the second end 164 of the sleeve member 160 further to inhibit
leakage from the joint 181.
[0037] The embodiment depicted in FIGS. 4A-4C, with the
pre-attached sleeve member, can eliminate the need to tighten
additional separate cinching members. It is contemplated that
various alterations of this or other embodiments may be practiced
within the scope of this disclosure. For example, the first end of
the sleeve member may be fixedly attached to the first prosthesis
portion whereby the second end of the sleeve member may be free to
engage the second prosthesis portion. For further example, one end
of the sleeve member may be fixedly attached to an intermediate
portion of one of the prosthesis portions such that the inner
surface of the sleeve member may engage a larger surface area of
the outer surface of the first and/or second prosthesis portions.
Furthermore, the sleeve member can be attached to the prosthesis
portion at a distance away from the end to expose the outer surface
of the prosthesis portion for coupling to the other prosthesis
portion. The sleeve member may include features configured to
assist a clinician in moving the sleeve member from the delivery
configuration to the deployed configuration. For example, the
sleeve member may include at least one tab member (not shown)
extending from the free end 162 of the sleeve member. The tab
member may be configured to allow the clinician to grasp the tab
member (e.g., by hand or with an instrument such as forceps) to
pull the sleeve member from the delivery configuration to the
deployed configuration. The tab member thereafter can be removed
from the body.
[0038] Although the system has been described in connection with
its primary intended use for repair of vascular trauma, those
skilled in the art will appreciate that the system also may be used
to repair other traumatic conditions. Non-limiting examples of such
conditions include aneurysms, such as abdominal aorta aneurysms,
and surgery for tumor removal.
[0039] FIGS. 5A-5H illustrate a method of treating a body vessel
200, e.g., during open surgery. The body vessel 200 may be found,
for example, in the leg of a patient having been subjected to a
traumatic episode resulting in a portion 201 of the body vessel 200
being torn away or otherwise severely damaged, as shown in FIG. 5A.
Pre-surgery preparation may be applied to the leg, and a trauma
pathway may be formed therein to gain open surgical access to the
body vessel 200 and the damaged portion 201 thereof. After clamping
the body vessel 200 on both ends of the portion 201 to restrict
blood flow temporarily, the body vessel 200 can be cut or
transected by the clinician into two portions 202, 204, as shown in
FIG. 5B. The transection may be at the damaged portion 201 of the
body vessel 200 or as far away as necessary from the damaged
portion to remove unhealthy portions of the body vessel or
unrepairable portions of the body vessel. Sutures 215 can be
attached to end openings 203, 205 of the body vessel portions 202,
204, respectively, to keep them fixed in place and open to
facilitate insertion of the prostheses. Forceps also may be used in
a similar manner. Any number of sutures 215 can be used to retain
the end openings 203, 205 in the open position, although
triangulation sutures can be sufficient, with each suture being
about 120 degrees apart from the adjacent suture. The first and
second prosthesis portions can be selected to have a radial
expanded cross-section to fit radially within the body vessel
portions 202, 204 and, together, a longitudinal length sufficient
to bridge the body vessel portions. To this end, each of the
prosthesis portions can be of equal length, or optionally, one of
the prosthesis portions can be a different length than the other
prosthesis portion so long as the coupled prosthesis is a suitable
length to bridge the vessel portions.
[0040] FIG. 5C depicts the first prosthesis portion 220 held in the
radially compressed, delivery configuration. The first prosthesis
portion 220 can be held in the compressed configuration by any
means known in the art. For example, the first prosthesis portion
220 may be held in the radially compressed configuration to be
delivered in a retaining member 235 of a delivery system. In one
example, the retaining member 235 can be a sheath or introducer,
such as described in U.S. Patent Application Publication No.
2008/0082158 to Tseng, which is incorporated herein by reference in
its entirety. Other retaining member configurations can be sutures
or another filamentary member and/or a sleeve or cuff member
disposed upon the first prosthesis portion 220. The first end 221
of the first prosthesis portion 220 can be inserted through the end
opening 203 into the vessel portion 202 by a sufficient distance
for the purposes of anchoring.
[0041] According to FIG. 5D, after insertion, the first prosthesis
portion 220 can be permitted to expand from the compressed
configuration to the expanded configuration. Such expansion may be
initiated by removal or retraction of the retaining member 235.
This can permit purchase of the first end 221 of the first
prosthesis portion 220 along the wall of the vessel portion 202 as
shown in FIG. 5D. Additionally, the anchoring members 230 can
engage the wall of the vessel portion 202 to fix the first end 221
of the first prosthesis portion 220 in place relative to the vessel
portion 202. The second end 222 of the first prosthesis portion 220
can remain outside of the vessel portion 202 in the space between
the vessel portion 202 and the vessel portion 204 for coupling of
the first prosthesis portion 220 to the second prosthesis portion
240 as described herein. The second end 222 can have the coupling
member 231.
[0042] FIG. 5E depicts the second prosthesis portion 240 held in
the radially compressed, delivery configuration by a retaining
member 235', such as described above with reference to the
retaining member 235. The first end 241 of the second prosthesis
portion 240 can be inserted through the end opening 205 into the
vessel portion 204 by a sufficient distance for the purposes of
anchoring. After insertion, the second prosthesis portion 240 can
be permitted to expand from the compressed configuration to the
expanded configuration. Such expansion may be initiated by removal
or retraction of the retaining member 235'. This can permit
purchase of the first end 241 of the second prosthesis portion 240
along the wall of the vessel portion 204, as shown in FIG. 5F.
Additionally, anchoring members 250 can engage the wall of the
vessel portion 204 to fix the first end 241 of the second
prosthesis portion 240 in place relative to the vessel portion 204.
The second end 242 of the second prosthesis portion 240 can remain
outside of the vessel portion 204 in the space between the vessel
portion 202 and the vessel portion 204 for coupling of the first
prosthesis portion 220 to the second prosthesis portion 240 as
described herein. The second end 242 can have the coupling member
251.
[0043] FIG. 5G depicts the first and second prosthesis portions
220, 240 coupled to one another to form the coupled prosthesis 280.
Coupling of the prosthesis portions will depend on the structure of
the coupling members 231 and/or 251, such as, e.g., shown in FIGS.
2A-2C. In one example, the sleeve member 260 can be inserted over
the exposed ends of the prosthesis portions before coupling the
prosthesis portions to one another. In this example, the inner ends
222, 242 of the first and second prosthesis portions can be
inserted through the opposing end openings of the sleeve member and
coupled to one another within the passageway of the sleeve member.
Alternatively, the second end of one of the first and second
prosthesis portions can be inserted a sufficient length into the
sleeve member such that the second end passes completely through
the passageway of the sleeve member to protrude from the opposing
end of the sleeve member. In this example, both of the second ends
of the first and second prosthesis portions can be exposed for more
efficient coupling. Once the prosthesis portions have been coupled,
the sleeve member can be moved along the outer surface of the
coupled prosthesis into position to cover the joint 281 of the
coupled prosthesis. In another example, a sheet of sleeve material
may be wrapped around the coupled prosthesis portions to form the
sleeve member for covering the joint after the coupling of the
first and second prosthesis portions. Such an alternative may
require sealing a seam extending along the body between the first
end and the second end of the sleeve member to inhibit leakage from
the seam.
[0044] In FIG. 5G, the prosthesis system formed, e.g., by the
coupled prosthesis portions, can bridge the first and second
portions 202, 204 of the transected body vessel. A conduit for
blood flow may be formed by the passageways of the first and second
prosthesis portions 220, 240 being in communication with one
another and with interior lumens of the first and second vessel
portions. The sleeve member can be positioned to be substantially
centered over the joint between the coupled prosthesis portions.
The cinching member can be tightened to cinch one of the ends or
portions of the sleeve member against one of the prosthesis
portions. A fluid-tight seal can be formed between the inner
surface 266 of the sleeve member and the outer surface 225 and/or
245 of the prosthesis portion to prevent leakage from the joint.
When present, a cinching member 269 and/or 270 can be tightened to
cinch the other end or another portion of the sleeve member against
the other prosthesis portion preferably to form a fluid-tight seal.
Portions of the outer surfaces of the first and second prosthesis
portions can sealably engage with the luminal walls of the body
vessel to inhibit leakage of blood and to force blood to flow
throughout the body vessel during emergency surgery, and
particularly to obtain hemostasis while maintaining blood
perfusion. FIG. 5H shows the prosthesis system deployed and
interconnecting the body vessel portions 202, 204 within the leg of
the patient. The prosthesis system can be adapted for permanent
placement within the patient, thereby obviating a need for
subsequent surgical intervention.
[0045] Alternatively, when the sleeve member is pre-attached to one
of the prosthesis portions, such as shown in FIGS. 4A-4C, the first
ends of the first and second prosthesis portions can be inserted
into the respective vessel portions 202, 204 as described above
with reference to FIGS. 5C-5F. With the sleeve member in the
delivery configuration, the ends of the first and second prosthesis
portions can be coupled to one another to form the coupled
prosthesis. Accordingly, the coupled prosthesis can bridge the
first and second portions 202, 204 of the transected body vessel
200. The sleeve member can be moved, such as by unrolling or
unfolding, from the delivery configuration to the deployed
configuration, such as shown in FIG. 4C. The inner surface of the
sleeve member can be placed into contact with the outer surface of
the first prosthesis portion. When present, a cinching member can
be tightened to cinch the first end of the sleeve member against
the first prosthesis portion. A fluid-tight seal can be formed
between the inner surface of the sleeve member and the outer
surface of the first prosthesis portion to prevent leakage from the
joint.
[0046] In alternative steps, an adhesive or biosealant 252 may be
applied between the sleeve member and circumferentially along an
outer surface of the coupled prosthesis, as shown in FIG. 4C. The
biosealant can be configured to facilitate attachment between the
materials of the sleeve material and the body and support structure
of the coupled prosthesis, and may be used instead of the flexible
members. It is contemplated that the biosealant can be used in
addition to the flexible member. The biosealant may also be
configured to seal the joint of the coupled prosthesis to inhibit
leakage along the joint. Suitable biosealant materials may include,
for example, cyanocrylates and fibrin glue.
[0047] It can be appreciated by those skilled in the art that
specific features of each embodiment of the system are
interchangeable among the various embodiments, even where no
references to the specific features are made.
[0048] Drawings in the figures illustrating various embodiments are
not necessarily to scale. Some drawings may have certain details
magnified for emphasis, and any different numbers or proportions of
parts should not be read as limiting, unless so-designated in the
present disclosure. Those of skill in the art will appreciate that
embodiments not expressly illustrated herein may be practiced
within the scope of the present invention, including those features
described herein for different embodiments, and may be combined
with each other and/or with currently-known or future-developed
technologies while remaining within the scope of the claims
presented here. It is therefore intended that the foregoing
detailed description be regarded as illustrative rather than
limiting. And it should be understood that the following claims,
including all equivalents, are intended to define the spirit and
scope of this invention.
* * * * *