U.S. patent application number 13/743256 was filed with the patent office on 2014-01-02 for devices, systems, and methods for repair of vascular defects.
The applicant listed for this patent is Ara J. Feinstein. Invention is credited to Ara J. Feinstein.
Application Number | 20140005586 13/743256 |
Document ID | / |
Family ID | 49778848 |
Filed Date | 2014-01-02 |
United States Patent
Application |
20140005586 |
Kind Code |
A1 |
Feinstein; Ara J. |
January 2, 2014 |
DEVICES, SYSTEMS, AND METHODS FOR REPAIR OF VASCULAR DEFECTS
Abstract
A balloon-expandable shunt is disclosed for shunting a vessel
which has a graft with two ends and at least one expandable support
element supporting the graft from within along a length at or near
at least one of its ends. The shunt is bifurcated at an aperture
that leads to a side-channel and which has a closed configuration
and an open configuration such that when the aperture is in the
closed configuration it defines a clot-resistant inner graft
surface and when the aperture is in the open configuration it is
configured to provide access to the shunt for a balloon that
actuates the expandable support element. A balloon configured for
actuating the shunt is also disclosed. A kit has a bifurcated graft
with at least one expandable support element and a balloon for
actuating the at least one expandable support element.
Inventors: |
Feinstein; Ara J.; (Paradise
Valley, AZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Feinstein; Ara J. |
Paradise Valley |
AZ |
US |
|
|
Family ID: |
49778848 |
Appl. No.: |
13/743256 |
Filed: |
January 16, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12819949 |
Jun 21, 2010 |
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13743256 |
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PCT/US2008/087849 |
Dec 19, 2008 |
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12819949 |
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61587570 |
Jan 17, 2012 |
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61016400 |
Dec 21, 2007 |
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61055428 |
May 22, 2008 |
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Current U.S.
Class: |
604/8 |
Current CPC
Class: |
A61F 2250/0067 20130101;
A61F 2250/0003 20130101; A61M 2039/0205 20130101; A61B 17/11
20130101; A61B 2017/1132 20130101; A61B 2017/1107 20130101; A61F
2002/075 20130101; A61F 2/844 20130101; A61B 17/12109 20130101;
A61B 17/12136 20130101; A61B 2017/111 20130101; A61F 2/958
20130101; A61M 27/002 20130101; A61F 2210/0014 20130101; A61F 2/064
20130101; A61F 2230/0069 20130101; A61F 2/07 20130101 |
Class at
Publication: |
604/8 |
International
Class: |
A61M 27/00 20060101
A61M027/00 |
Claims
1. A balloon expandable shunt for shunting a disrupted vessel,
comprising: a graft defining a first lumen having an expanded-state
diameter and extending between first and second ends of the graft;
at least one expandable support element supporting a length of the
graft from within near at least one of said first and second ends;
a side channel defining a second lumen and configured to receive a
balloon for actuating the at least one expandable support element;
a bifurcation at a portion of the graft defined by an intersection
of the first lumen and the second lumen; and an elongate aperture
in the graft circumscribing the bifurcation and having a
substantially closed configuration and a substantially open
configuration such that when the aperture is in the substantially
closed configuration it defines a clot-resistant inner graft
surface and when the aperture is in the substantially open
configuration it is configured to provide access to the first lumen
for a balloon for actuating the at least one expandable support
element.
2.-42. (canceled)
Description
PRIORITY CLAIM AND CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority of U.S.
Provisional Application No. 61/587,570, which was filed Jan. 17,
2012, the entire contents of which are hereby incorporated herein
by reference and should be considered part of this
specification.
[0002] This application is a continuation-in-part of U.S.
application Ser. No. 12/819,949, which was filed Jun. 21, 2010,
which is a continuation-in-part of PCT Application No.
PCT/US2008/087849, which was filed on Dec. 19, 2008 and published
on Jul. 2, 2009 as WO 2009/082718, the entire contents of which are
hereby incorporated herein by reference and should be considered
part of this specification. The above-referenced PCT application
claims prior to and the benefit of U.S. Provisional Application
Nos. 61/016,400 and 61/055,428, filed Dec. 21, 2007 and May 22,
2008, respectively, each titled "Devices, Systems, and Method for
Repair of Vascular Defects," which are also hereby incorporated by
reference in their entirety, including without limitation, the
descriptions of the vascular devices and the associated methods of
use to repair vascular defects.
BACKGROUND
[0003] 1. Field
[0004] Embodiments of the disclosure relate to the field of
vascular prostheses for repairing a vascular defect.
[0005] 2. Description of Related Art
[0006] Large vascular defects arise when all or a portion of a
vessel is severed or damaged to the extent that the vessel loses
functionality as a conduit through which body fluid, such as blood,
can flow. Blood vessels, for example, may be severed or lacerated
traumatically in an accident or under controlled, surgical
conditions such as amputation, coronary artery bypass grafting, or
construction of other anastomoses. Rapid fluid loss and, in the
case of circulatory defects, loss of tissue perfusion is often
characteristic of large vascular defects. The potential fluid loss
in emergencies and during surgery can be life-threatening unless
brought under control quickly and effectively. Furthermore,
escaping fluid can obscure the view of the working surgical
site.
[0007] To minimize fluid loss from large vascular defects,
harvested grafts are connected to bridge, or shunt, separate
portions of the natural vasculature, including portions from which
fluid is being, or is expected to be, lost. Such grafts serve to
restore functionality to the damaged vessels by acting as a bridge
or tube through which fluid can flow. This approach, however, is
time consuming and often not possible during exigent circumstances,
such as those encountered in an emergency room.
SUMMARY OF THE INVENTION
[0008] An aspect of the present disclosure relates to methods and
systems suitable for repair of both small and large blood vessel
defects. Some embodiments are devices having an expanded state and
an unexpanded state. Various embodiments include bidirectional
balloon expandable covered stents for traumatic vascular defects.
Some embodiments comprise a stented member, an elongate graft
member and an access portion connected to the elongate graft
member, which may or may not be comprised of the same materials. In
some embodiments, the access portion is elliptically shaped so as
to minimize shear stress on blood making its way through the
device. Some embodiments have a first side, a second side, and a
middle portion which extends between the first side and the second
side. In some embodiments, the device is sized such that it can
extend across a ruptured portion of a vessel and when in its
expanded state can seal the vessel so that none of the fluid
flowing through the vessel escapes as it flows past the region of
intersection between the device and the vessel.
[0009] In some embodiments, the device is comprised of a PTFE graft
bonded to one or more balloon expandable stents, although the graft
may be made of any other material suitable for repairing a vascular
defect. Similarly, the stent material may be a metal, a metal
alloy, or other material or combination of materials and/or
biomaterials suitable for implantation or for use in other
biomedical applications. Such materials are well known in the art.
The stent may be of any suitable material and configuration,
including drug-eluting, polymeric, composite metal, annularly
shaped, and ovalularly shaped.
[0010] In some embodiments, the device is further comprised of an
access portion through which a balloon catheter can access and
manipulate the interior walls of the device that can serve as a
fluid conduit, or any other conduits of which the device is
comprised in any of its variations. Such variations include, for
example, pockets within a conduit that contain fluids to be
released at a time subsequent to implantation or positioning into
the vessel undergoing treatment. The access portion need not be
located in the center of the device. Further, it may extend from
the device at a near 0.degree. angle or any other suitable angle
relative to a longitudinal axis through the shunt. It may extend
from or into the device.
[0011] According to one aspect of the disclosure, a vascular repair
device is provided that comprises at least one vascular support
element, such as a stent made of stainless steel, cobalt-chromium
alloy, or Nitinol, and at least one graft coupled to the vascular
support. According to some embodiments, the vascular support
element is coupled to an inner surface of the graft. According to
some embodiments, the vascular support element is coupled to an
outer surface of the graft. According to some embodiments, the
vascular support element is coupled to outer and inner surfaces of
the graft. According to some embodiments, the vascular support
element is coupled to the graft between an outer surface and an
inner surface of the graft.
[0012] The vascular support element may support the graft either
along its entire length or along only a portion of its length. One
aspect of the invention involves recognizing that the length of the
portion of the support element (e.g., a stent) supporting the graft
(e.g., the portion of the stent attached to the graft) wall can be
greater than or equal to the maximum diameter of the graft lumen
when in an expanded state. Preferably, the ratio of the length of a
vascular support element that is supporting the graft from within
(e.g., attached to) to the maximum diameter of the graft lumen may
be in the range of 1:1 to 2:1. In some embodiments, that ratio is
in the range from 1:1 to 2.5:1. In other embodiments, that ratio is
in the range of 1:1 to 3:1 or higher. While 1:1 is the preferred
ratio, the ratio in other embodiments can be slightly less than
1:1.
[0013] The graft includes an access portion through which a surgeon
can access the vascular support. The device is suitable for
placement and/or introduction through a vascular defect into the
vessel lumen either directly or over a guidewire. The vascular
support expands to engage at least one portion of a vessel at a
location removed from a vascular defect to couple the graft to the
vessel. In some embodiments, the graft has a configuration suitable
to inhibit fluid leakage from the vessel through the defect.
[0014] The graft can be of synthetic or biologic materials, or a
combination of both. The graft may also include one or more
therapeutic agents. Such agents could include, for example, but
without limitation, vasodilators, vasoconstrictors, hydrophobic or
hydrophilic coatings and/or materials, anticoagulant coatings
and/or materials such as heparin, controlled-diffusion polymers,
antibiotic materials, antiproliferative materials, agents that
induce vascular proliferation and/or remodeling, immunosuppressive
drugs, proteins, carbohydrates, self-assembled monolayers,
stainless steel, or any other suitable agent that provides a
therapeutic or beneficial effect. Such agents can be coated,
bonded, or otherwise integrated into or with the graft material.
Additionally, such agents can elute from the inside of the graft,
from the outside of the graft, from both the inside and outside of
the graft, or from only select regions of the graft. In some
embodiments, the graft also is formed of a material that can be
sutured. Thus, a generally fluid-tight seal or interface can be
obtained between the graft and a vessel.
[0015] In some embodiments, a balloon can be inserted through the
access portion in the graft and placed within the vascular support.
By inflating the balloon, the at least one vascular support element
can be expanded to make sealing contact with the vessel walls. In
other embodiments, the at least one vascular support element can
comprise a self-expanding material, such as Nitinol (Nickel
Titanium Naval Ordinance Laboratory) and/or an electroactive
polymer and/or can have mesh-like or stent-like structure. The
vascular support also can include therapeutic agents in addition to
or alternative to a graft which elutes such agents.
[0016] According to another aspect of the disclosure, there is
provided a vascular repair device comprising at least two vascular
support elements and at least one graft extending between the
vascular support elements. The graft includes at least one access
portion through which one or more of the vascular support elements
can be accessed. Each vascular support element is expanded to
engage a portion of the vessel at a location remote from a vascular
defect to couple the graft to a vessel. The graft has a
configuration suitable to inhibit fluid leakage from a vessel
through a defect. As noted before, the graft may be, for example,
synthetic or biologic. Notably, in other embodiments, the function
of the two support elements can be served by a single support
element.
[0017] In some embodiments, the graft can be advantageously
configured to repair a vascular defect where a section of a vessel
has been completely severed between a first vessel portion and a
second vessel portion. Some embodiments allow linkage of more than
two severed vessel portions. In some embodiments, the graft
preferably has a sufficient length and shape to extend between the
first and second vessel portions. One of the vascular support
elements is inserted into the first vessel portion to couple the
graft thereto, and another vascular support element is inserted
into the second vessel portion to couple the graft to the second
vessel portion. In some embodiments, the vascular support elements
are expandable by balloon or are fully or partially self-expanding,
and can be delivered along with the graft or separately delivered
and subsequently coupled to the graft. In some embodiments, one or
more of the vascular support elements and/or the graft can be
biodegradable, such as in embodiments that allow for vascular
remodeling/repair sufficient to eventually render the repaired
vessel effective for conducting fluid without assistance of a graft
member. Where the graft serves the function of a healthy, normal
vessel wall, of course, it preferably is not biodegradable.
[0018] According to an additional aspect of the disclosure, a
vascular repair system is provided comprising at least one vascular
support element defining a proximal flow orifice and a distal flow
orifice, at least one biocompatible graft, and at least one sealing
member. The graft includes an access portion through which access
to the vascular support can be obtained. The graft also has a
suitable configuration to provide generally a barrier to fluid
leakage from a vessel having a defect. The sealing member closes
the access portion of the graft so as to provide a barrier to fluid
transfer through the access portion of the graft once implanted. In
some embodiments, the access opening is sized to permit placing a
balloon within a vascular support element to expand the vascular
support element.
[0019] A preferred embodiment of repairing a vascular defect is
also provided that involves providing a vascular graft with one or
more vascular support elements coupled to the graft. Once access to
a vascular defect has been obtained, a vascular support element is
inserted through the defect in a vessel and positioned near
competent tissue. The graft is configured to bridge the defect,
thereby extending between at least two sections of vessel. An
expandable member (e.g., a balloon) is inserted through an access
port in the graft and delivered to a position lying within each
vascular support, separately or in tandem. Expansion (e.g., by
inflation) of the expandable member causes the vascular support
elements to engage the competent tissue, preferably in a
circumferential manner. The vascular support elements may each be
expanded separately or together, depending on the application and
circumstances. The expandable member is then withdrawn from the
graft and the access port is closed. Thus, the expandable member
anchors the graft to the vessel and the defect is repaired.
[0020] Another preferred embodiment of repairing a vascular defect
is also provided that involves a vascular graft, which is
self-expanding or is expanded by an internal force (e.g., by an
expandable scaffolding). Additionally, in some embodiments, the
graft can include a conventional septum side port--in addition to
or integrated with an inflation port--to provide additional access
to the central blood flow through the graft when in situ.
[0021] In other embodiments, other types of vascular coupling
devices can also be used as an alternative to or in addition to
wire support members (e.g., stent-like structures). For example, an
additional way to attach the graft to the ruptured vasculature
involves using one or more inflatable cuffs at each end of the
graft to secure the graft to the vascular wall. One or more of the
cuffs can be inflated using an inflation port that is either
internally or externally accessible.
[0022] Another aspect of the disclosure involves a shunt device for
shunting a traumatically disrupted vessel. The shunting device
comprising a body having at least one lumen extending therethrough
between first and second ends of the body. At least a segment of
the body is expandable from a first state to second, expanded
state. In the expanded state, the body segment is generally equal
in size to a dimension across the vessel. An access port provides
access into the lumen and is disposed between the first and second
ends of the body. The access port is sized to receive at least a
portion of a balloon for expanding at least the body segment to the
second state.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1A shows a vascular repair device configured according
to an embodiment.
[0024] FIG. 1B shows a vascular repair device configured according
to an embodiment.
[0025] FIG. 1C shows a cross-sectional view of a portion of a
vascular repair device configured according to an embodiment.
[0026] FIG. 1D shows a vascular repair device configured according
to an embodiment.
[0027] FIG. 2A shows a vascular repair device inserted into a
ruptured blood vessel.
[0028] FIG. 2B shows a vascular repair device inserted into a
ruptured blood vessel and an expandable member inserted into the
device.
[0029] FIG. 2C shows a vascular repair device in an expanded
state.
[0030] FIG. 2D shows a vascular repair device in an expanded state
and sealed with a clip.
[0031] FIG. 3A shows a first stented member of a vascular repair
device extending into a ruptured vessel portion at one end and into
a graft member at its other end.
[0032] FIG. 3B shows an expandable member inserted into a portion
of the first stented member.
[0033] FIG. 3C shows an expandable member and the first stented
member in an extended configuration such that it prevents fluid
from escaping through the ruptured portion of the first vessel
portion.
[0034] FIG. 3D shows a first stented member sealed with a clip.
[0035] FIG. 3E shows a device with a second stented member
extending into a second end of a graft member at one end and into a
ruptured portion of a vessel portion at its other end.
[0036] FIG. 3F shows a device with an expandable device in a
substantially unextended configuration extending through the second
stented member.
[0037] FIG. 3G shows the portions of the embodiment shown in FIG.
2F with the second stented member in an expanded configuration.
[0038] FIG. 3H shows an embodiment sealed with a clamp placed over
the second stented member.
DETAILED DESCRIPTION OF THE DRAWINGS
[0039] FIG. 1A shows an embodiment of a vascular prosthetic device
100 in its expanded state designed for endoluminal applications.
The device 100 in this embodiment comprises a sleeve or graft
portion 106 supported at least at its ends by a plurality of
tubular wire support members 104. While in the illustrated
embodiment, the graft portion 106 extends between the support
members 104, in other embodiments, a single support member 104 can
be used that extends through the graft portion 106. An access
portion or port 102 communicates with a lumen 108 of the graft
portion 106. The access portion 102 is shown in an unbiased
configuration wherein the access portion 102 is compressed upon
itself to form a seal.
[0040] The graft portion 106 in the illustrated embodiment has a
tubular shape and defines at least one lumen 108. The lumen 108
terminates at the ends of the graft in first and second openings
108a, 108b. The graft portion 106, however, can have other
configurations in other embodiments. For example, but without
limitation, the graft portion can have a Y-shape, a T-shape or an
X-shape with a plurality of openings (e.g., three or greater). In
some embodiments, all of the openings may communicate with one
another, and in other embodiments only certain openings communicate
with one another.
[0041] In some embodiments, at least some of the ends of the graft
portion 106 do not include a corresponding support element 104 and
instead are designed to be coupled with a corresponding end of
another vascular prosthetic device. In other embodiments, the
support elements 104 are used to interconnect a plurality of
vascular prosthetic devices. In this manner, a plurality of
vascular prosthetic devices can be linked together to repair,
replace, bypass or supplement the physiologic vasculature of a
patient. The linking of the prosthetic devices together can be done
before being placed in a patient's body or during placement within
a patient's body.
[0042] The graft 106 may be formed from any of a variety of
synthetic polymeric materials, or combinations thereof, including
PTFE, PET, PE, nylon, Urethane, Dacron, polyester or woven
textiles. The material of the graft 106 preferably has a relatively
low inherent elasticity or low elasticity until expanded to or
beyond its intended expanded diameter.
[0043] In the illustrated embodiment, the graft 106 is situated
concentrically outside the support members 104. However, other
embodiments may include a sleeve situated instead concentrically
inside one or both of the support members or on both the inside or
outside of at least one of the support members 104. Alternatively,
one or both of the supports may be embedded within the graft.
[0044] The support members 104 are attached to the graft 106,
either on the inside or outside surfaces thereof, by any of a
variety of ways, including laser bonding, adhesives, clips,
sutures, dipping or spraying or other means, depending upon the
composition of the graft and the overall graft design.
[0045] In the illustrated embodiment, a middle section of the graft
106 is unsupported by the support members 104. This permits the
graft 106 to be folded or bent so as to be more easily inserted
into a partially ruptured vessel or a vessel hole. In other
embodiments, increased flexibility of the prosthetic device can
also be obtained by removing sections of the wire support between
the ends of the device (for example, by forming gaps between wire
segments along the longitudinal axis of the device and/or by
forming gaps around the circumference of the tubular wire
structure). In some embodiments, flexible longitudinal struts can
be used to link together the two or more support members 104, which
are spaced apart along the longitudinal axis of the device.
[0046] In the illustrated embodiment, the support member 104 has a
stent-like structure that is capable of being expanded for a
compact state (e.g., collapsed state) to an expanded state. As best
seen in FIGS. 1A and 1B, the support member 104 comprises a wire
frame structure with a generally tubular appearance at least when
in the expanded state. The wire frame structure has linked wire
segments that allow it to be expanded in diameter in situ.
[0047] The support members 104 and graft portion 106 are
cylindrical and hollow generally to match the shape of a typical
blood vessel. However, the stent members 104 and graft portion 106
may be shaped differently depending on the requirements of a
particular surgical protocol or requirements of the particular
application, as discussed in greater detail below. The access
portion 102 and access portion conduit 108 are elliptical in shape
so as to minimize shear forces acting against blood cells traveling
through the vascular access device 100 along the inner wall
107.
[0048] FIG. 1B shows a vascular access device 100 as shown in FIG.
1A wherein the access portion 102 has been manipulated by force F
so as to separate the walls of the access portion conduit 108 and
to provide an open pathway for communication between the
environment outside the graft portion 110 and the environment
inside the graft portion (not shown). When force F is removed from
the access portion 102, the access portion returns to the
configuration shown in FIG. 1A. Thus, some embodiments of the
present inventions include a deformable, self-biased access portion
102 that deforms under force and returns to its resting
configuration when such force is released. While not shown, other
embodiments of the device 100 can include a valve situated at the
access portion 102 or communicating therewith to permit medical
instruments to be passed into, manipulated in, and removed from the
device through the access portion 102 with minimal fluid (e.g.,
blood) loss.
[0049] FIG. 1C shows a portion of the vascular access device in the
self-sealed configuration of FIG. 1A. Due at least in part to its
elliptical shape, the access portion conduit 108 is closed upon
itself along a generally straight line. Furthermore, the elliptical
shape and, in some embodiments, the material composition of the
access portion 102 discourage folding along the inner wall 107 of
the vascular access device 100. This configuration helps ensure
that irregularities, and the shear forces on body fluids flowing
along the inner walls of the device 100 and opportunities for fluid
components to pool, clot, stagnate, or aggregate that such
irregularities are known to cause are minimized.
[0050] FIG. 1D shows a cross-sectional view of an embodiment of a
vascular prosthetic device 110 designed for endoluminal
applications in its expanded state. The device 110 in this
embodiment comprises a sleeve or graft portion 116 supported at
least at its ends by a plurality of vascular support members 114.
While in the illustrated embodiment, the graft portion 116 extends
between the vascular support members 114, in other embodiments, a
single support member can be used that extends through the graft
portion 116. An access portion or port 112 communicates with a
lumen 118 of the graft portion 116. The maximum diameter of the
graft lumen is labeled L. In some embodiments, the maximum diameter
of the lumen can be anywhere from 6 mm to 1.2 cm. The length of the
vascular support element supporting from within (e.g., attached to)
the graft is labeled S. Thus, the ratio of the length of the
vascular support element 114 supporting the graft 116 from within
to the maximum diameter of the graft lumen 118 can be expressed as
S:L.
[0051] The length of the portion of the vascular support element
114 supporting the graft wall S can be greater than or equal to the
maximum diameter of the graft lumen L when in an expanded state.
Preferably, the ratio of the length of a vascular support element
114 that is supporting the graft from within S to the maximum
diameter of the graft lumen L may be in the range of 1:1 to 2:1. In
some embodiments, that ratio is in the range from 1:1 to 2.5:1. In
other embodiments, that ratio is in the range of 1:1 to 3:1 or
higher. While 1:1 is the preferred ratio, the ratio in other
embodiments can be slightly less than 1:1.
[0052] FIG. 2A illustrates an embodiment of the vascular access
device 100 in the repair of a small vascular defect 212. A vascular
access device 100 is situated in a blood vessel 213 such that the
device 100 extends across a ruptured portion of the vessel 212. The
device 100 is further situated such that the access portion 102 of
the graft 106 provides access to the elongate graft portion 106
from the surgeon's working environment 216. The device 100 may be
so situated by inserting one end of the graft 106 into the vessel
213 through the ruptured portion of the vessel 212 and
simultaneously or subsequently similarly inserting the other end of
the graft 106. Alternatively, the device 100 may be inserted over a
guidewire. The device of the present embodiment is comprised of a
T-piece 214 and an elongate graft portion 106. Although the
intersection between the T-piece 214 and the elongate graft portion
106 is shown such that these portions are perpendicular to one
another, they may be manufactured or, in some embodiments,
manipulated to intersect at various angles ranging from nearly
0.degree. to nearly 90.degree. and may further be comprised of
materials or design that allows a surgeon to easily adjust the
angles of intersection between the T-piece and various portions of
the graft portion 106. For example, the device could take on a
Y-shape or an M-shape rather than a T-shape. Furthermore, the
access portion 102 need not intersect the graft portion 106 at a
constant angle.
[0053] The present embodiment further comprises at least one stent
portion 104 to provide support to openings 214 and the elongate
graft portion 106. The stent portion 104 is coupled to the elongate
graft portion 106 such that the stent portion can affect expansion
of the elongate graft portion 106. The stent portion 104 may extend
along the length of the graft 106 and extend out the openings 214
of the graft 106. The stent portion 104 may be integral with,
intermeshed with or embedded within, or separate from the graft
portion 106. The stent portion 104 may comprise two stent portions
or more, and at least a portion of the at least one stent portion
104 can be attached or otherwise coupled to the outside or the
inside of the graft 106.
[0054] FIG. 2B shows a vessel 213 and a vascular access device 100
and further shows a balloon catheter 218 comprised of a pump
portion 220 and a catheter. The catheter 218 is comprised of a
balloon portion 222 in fluid communication a tube portion 224 and a
pump portion 220. The catheter 218 may be any suitable catheter
configuration. The balloon portion 222 extends into the elongate
graft member 106 such that it pushes the graft member 106 into an
expanded configuration upon expansion.
[0055] The balloon catheter 218 is positioned inside the graft 106
through the conduit 108 and extends through the access portion 102
such that when the balloon is expanded it forces the graft 106 to
expand toward the vessel wall 213 and to thereby create a seal
around the ruptured portion of the vessel 212 between the ruptured
portion 212 and the graft 106 as shown in FIG. 2C where the
vascular access device 100 is in an expanded configuration and
extends across a ruptured wall of the vessel 213. The access
portion 102 extends out of the ruptured wall into the environment
accessible to the surgeon 216.
[0056] FIG. 2D shows a vascular access device 100 in an expanded
configuration and sealingly engaged with a vessel 213 along
ruptured wall 212 with a clip 226 sealing the access portion 102 of
the graft member 106. The device 100 is expanded such that the at
least one stent portion 104 circumscribes the inner vessel wall 213
and thereby creates a tunnel through which fluid in the vessel can
pass. The balloon (not shown) is removed and the access portion 102
of the graft 106 is sealed using a clip 226 or other suitable
sealing means. Such sealing means could comprise, for example,
adhesion, heat bonding, closure of a valve provided on an access
portion of a PTFE graft, self-sealing, or any other suitable means
identifiable by one of ordinary skill in the art. The seal may be
reversible such that before or after the seal is originally
applied, the access port 102 can be used, for example, for passage
of a medical implement such as an embolectomy catheter, infusion of
medications including anticoagulants or thrombolytics, infusion of
contrast for imaging, and as access for a guidewire or other
vascular and/or surgical device.
[0057] FIGS. 3A-3H show the device employed to repair of a large
vascular defect. As shown in FIG. 3A, a defect is comprised of two
vessel portions 330, 332, a first portion 330 and a second portion
332. The first portion 330 comprises a first ruptured wall 334, and
the second portion 332 comprises a second ruptured wall 336. The
vascular access device comprises a first stented member 330
comprising a first graft portion 340 that is further comprised of
an access portion 342, a second graft portion 344 extending, or
configured to extend, between the first ruptured wall 334 and the
second ruptured wall 336, and a second stented member 354 as shown
in FIG. 3E that is substantially similar to the first stented
member 300.
[0058] With further reference to FIG. 3A, the first stented member
300 is inserted into the end of the vessel portion 330 through the
vascular defect 334 such that the elongate portion of the first
stented member 340 extends both into the vessel 330 through the
vascular defect 334 and out of the ruptured wall, or vascular
defect 334, and into the second graft portion 344. The portion of
the elongate portion of the graft 340 extending out of the ruptured
wall 334 fits within the second graft portion 344.
[0059] With reference to FIG. 3B, a balloon catheter (not shown) is
inserted into the access portion 342 and the stent members 104 and
graft portion 340 are expanded via the balloon catheter 348 as
shown in FIG. 3C. The balloon 222 is inflated until there is a seal
between the graft 340 and the vessel 330 and until substantially no
fluid escapes from between the ruptured wall 334 and the elongate
graft portion 340 of the first stented member 300. The balloon
catheter 348 may employ various known techniques, such as injection
of saline solution, to cause expansion of a balloon 350 or another
expandable device capable of applying enough force to a stented
member 300 and create a seal against a vessel wall.
[0060] FIG. 3C shows the balloon catheter 348 within the first
stented member 300. The first stent member 300 is in an expanded
configuration. The second graft member 344 extends from the first
stented member 300. The first stented member 300 is placed in
sealing engagement with the first vessel portion 330 and with the
elongate graft member 340. The balloon 222 may be removed as shown
in FIG. 3D and the access portion may be sealed using a clamp 352
or any other suitable method of preventing fluid from escaping
between the ruptured vessel wall 334, the second graft portion 344
and the elongate graft member 340.
[0061] FIG. 3E shows a second stented member 354 inserted into the
second graft member 344 and the second ruptured vessel wall 336
such that a first end of the second elongate graft portion 356
extends into the second graft portion 344 and a second end extends
into the second ruptured vessel wall 336. The balloon inflation
process described above is repeated such that the second stented
member 354 sealingly engages with the second vessel wall portion
332 as shown in FIG. 3G after passing through the intermediate step
shown in FIG. 3F and described above to complete a sealed flow path
as shown in FIG. 3G defined by the first stented member 300 and
second stented member 354 and the second graft portion 344.
Finally, the balloon catheter is removed as shown in FIG. 3H, and
the second device is sealed at its access portion using a second
clamp 358 or any other suitable method of sealing.
[0062] As understood from the above description, each of the shunt
devices illustrated in FIGS. 1A-3H can be used to quickly repair
damages or ruptured vessels. The inflation balloon can be included
with the shunt device in a surgical kit and can be preassembled
with the shunt so that a surgeon need only place the shunt device
within a vessel or between vessel segments and inflate the balloon
to place the device. The balloon can then be deflated, removed
through the access portion and disposed. The surgeon can then
further close off the access portion by tying it closed or by using
a provided clamp, clip, tie, or other sealing means as described
above. Once in place, the device shunts body fluid across the
damaged vascular structure and can remain in place temporarily
until replaced by a more permanent solution or for an expended
period of time, including permanently.
[0063] In other embodiments, the graft portion can be
self-expanding or can be expanded by an internal force (e.g., by an
expandable scaffolding). If the graft sleeve and/or an internal
mechanism is self-expanding, the inflation port (e.g., a side
channel or valve) can be omitted from such embodiments.
Additionally, in some embodiments, the graft can include a
conventional septum side port--in addition to or integrated with an
inflation port--to provide additional access to the central blood
flow through the graft when in situ.
[0064] Other vascular coupling devices can also be used in some
embodiments as an alternative to or in addition to the wire support
members specifically described above. For example, an additional
way to attach the graft to the ruptured vasculature involves using
one or more inflatable cuffs at each end of the graft to secure the
graft to the vascular wall. By using inflatable cuffs, a longer
"landing zone" against the vascular wall can be obtained in
comparison to the stents described above. One or more of the cuffs
can be inflated using one or more inflation ports that are either
internally or externally accessible.
[0065] Although this disclosure has been disclosed in the context
of certain preferred embodiments and examples, it will be
understood by those skilled in the art that the present disclosure
extends beyond the specifically disclosed embodiments to other
alternative embodiments and/or uses of the disclosure and obvious
modifications and equivalents thereof. In particular, while the
present vascular access devices, systems, and methods have been
described in the context of particularly preferred embodiments, the
skilled artisan will appreciate, in view of the present disclosure,
that certain advantages, features and aspects of the system may be
realized in a variety of other applications, such as sealing of
conduits within a mammalian body other than blood vessels.
Additionally, it is contemplated that various aspects and features
of the disclosure described can be practiced separately, combined
together, or substituted for one another, and that a variety of
combination and subcombinations of the features and aspects can be
made and still fall within the scope of the disclosure. Thus, it is
intended that the scope of the present disclosure herein disclosed
should not be limited by the particular disclosed embodiments
described above, but should be determined only by a fair reading of
the claims.
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