U.S. patent application number 12/769506 was filed with the patent office on 2011-03-03 for apparatus and method of placement of a graft or graft system.
This patent application is currently assigned to Endologix, Inc.. Invention is credited to Daniel Clair, Kevin Mayberry, Stefan G. Schreck, Craig Welk.
Application Number | 20110054586 12/769506 |
Document ID | / |
Family ID | 42321183 |
Filed Date | 2011-03-03 |
United States Patent
Application |
20110054586 |
Kind Code |
A1 |
Mayberry; Kevin ; et
al. |
March 3, 2011 |
APPARATUS AND METHOD OF PLACEMENT OF A GRAFT OR GRAFT SYSTEM
Abstract
Some embodiments relate to endoluminal prostheses having a first
stent portion and a second stent portion, a main graft body
comprising first, second, and third portions, the second portion
having a cross-sectional size that is significantly larger than a
cross-sectional size of the first or third portions, and also
significantly larger than a cross-sectional size of the target
vessel. In some embodiments, the first portion of the main graft
body can be attached to the first stent portion and the third
portion of the main graft body can be attached to the second stent
portion. The prostheses can be configured such that the second
portion of the main graft body is not directly attached to the
first stent portion, the second stent portion, or any other
internal support structure. In some embodiments, one or more
openings can be formed in the second portion of the main graft
body.
Inventors: |
Mayberry; Kevin; (Mission
Viejo, CA) ; Clair; Daniel; (Shaker Heights, OH)
; Welk; Craig; (Tracy, CA) ; Schreck; Stefan
G.; (Fallbrook, CA) |
Assignee: |
Endologix, Inc.
Irvine
CA
|
Family ID: |
42321183 |
Appl. No.: |
12/769506 |
Filed: |
April 28, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61173485 |
Apr 28, 2009 |
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61228048 |
Jul 23, 2009 |
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61231898 |
Aug 6, 2009 |
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Current U.S.
Class: |
623/1.11 ;
623/1.13; 623/1.35 |
Current CPC
Class: |
A61F 2/966 20130101;
A61F 2002/9511 20130101; A61F 2002/075 20130101; A61F 2250/0039
20130101; A61F 2002/067 20130101; A61F 2/856 20130101; A61F 2/89
20130101; A61F 2/97 20130101; Y10T 29/49863 20150115; A61F 2002/065
20130101; A61F 2002/061 20130101; A61F 2/954 20130101; A61F 2/90
20130101; A61F 2/07 20130101 |
Class at
Publication: |
623/1.11 ;
623/1.13; 623/1.35 |
International
Class: |
A61F 2/84 20060101
A61F002/84; A61F 2/82 20060101 A61F002/82 |
Claims
1. An endoluminal prosthesis, comprising: a first stent portion and
a second stent portion; a main graft body comprising a first
portion, a second portion, and a third portion, the second portion
having a cross-sectional size that is significantly larger than a
cross-sectional size of the first portion or the third portion, and
also significantly larger than a cross-sectional size of the target
vessel; and one or more openings formed in the second portion of
the main graft body; wherein: the first portion of the main graft
body is attached to the first stent portion and wherein the third
portion of the main graft body is attached to the second stent
portion; and the second portion of the main graft body is not
directly attached to the first stent portion, the second stent
portion, or any other internal support structure.
2. The endoluminal prosthesis of claim 1, wherein the
cross-sectional size of the second portion is approximately 30%
larger than the cross-sectional size of the target vessel.
3. The endoluminal prosthesis of claim 1, wherein the
cross-sectional size of the second portion is from approximately
20% to approximately 40% larger than the cross-sectional size of
the target vessel.
4. The endoluminal prosthesis of claim 1, wherein the main graft
body comprises two openings formed in the second portion of the
main graft body.
5. The endoluminal prosthesis of claim 1, wherein two openings are
formed in the second portion of the main graft body, the two
openings being separated by an angle between approximately 130
degrees and approximately 170 degrees.
6. The endoluminal prosthesis of claim 5, wherein the two openings
are separated by approximately 150 degrees.
7. The endoluminal prosthesis of claim 1, wherein the main the
first portion of the main graft body defines a generally tubular
shape.
8. The endoluminal prosthesis of claim 1, wherein the main graft
body comprises one or more cutouts in the first portion
thereof.
9. The endoluminal prosthesis of claim 1, further comprising a
branch graft supported by the main graft body and advanced through
one of the openings.
10. The endoluminal prosthesis of claim 9, further comprising a
bare or covered stent advanceable through the branch graft.
11. The endoluminal prosthesis of claim 1, wherein the main graft
body is bifurcated.
12. The endoluminal prosthesis system of claim 1, wherein the main
graft body is formed from a bi-directionally expanded, layered PTFE
material.
13. The endoluminal prosthesis of claim 1, wherein the main graft
body further comprises at least one radiopaque suture or marker
attached thereto.
14. The endoluminal prosthesis of claim 1, wherein the second
portion is located between the first and third portions.
15. The endoluminal prosthesis of claim 1, wherein the first and
second stent portions are interconnected by one or more connectors
spanning at least the second portion of the graft.
16. The endoluminal prosthesis of claim 15, wherein the end
portions of the one or more connectors are slidably supported by
the first and second stent portions.
17. The endoluminal prosthesis of claim 1, wherein a distance
between end portions of the main graft body is greater than a
distance between opposing end portions of the first stent portion
and the second stent portion.
18. An endoluminal prosthesis, comprising: a main graft body
comprising a first portion, a second portion, and a third portion,
the second portion having a cross-sectional size that is
significantly larger than a cross-sectional size of the first
portion or the third portion, and also significantly larger than a
cross-sectional size of the target vessel; and one or more openings
formed in the second portion of the main graft body; wherein: the
first portion of the main graft body is radially supported by a
first support member; the third portion of the main graft body is
radially supported by a second support member; and the second
portion of the main graft body is free of radial support from a
stent or other prosthetic device.
19. The endoluminal prosthesis of claim 18, wherein the first and
second support members are connected by generally axially oriented
struts.
20. The endoluminal prosthesis of claim 19, wherein the second
portion of the main graft body has no attachment points to the
support members or struts.
21. An endoluminal prosthesis, comprising: a main graft body
comprising a first portion, a second portion, and a third portion,
the entirety of the second portion having a cross-sectional size
that is significantly larger than a cross-sectional size of the
first portion or the third portion, and also significantly larger
than a cross-sectional size of the target vessel; a support member
positioned within the main graft body, the support member having a
first support portion, a second support portion, and a third
support portion; and one or more openings formed in the second
portion of the main graft body; wherein: the first portion of the
main graft body is attached to the first support portion of the
support member at a first number of attachment points; the second
portion of the main graft body is attached to the second support
portion of the support member at a second number of attachment
points; the third portion of the main graft body is attached to the
third support portion of the support member at a third number of
attachment points; and the third number of attachment points is
less than the first number of attachment points and the third
number of attachment points.
22. The endoluminal prosthesis of claim 21, wherein the second
support portion comprises one or more connecting members that
connect the first and third support portions, and the second
portion of the main graft body is attached to the connecting
members.
23. The endoluminal prosthesis of claim 21, wherein the
cross-sectional size of the second portion is from approximately
20% to approximately 40% larger than the cross-sectional size of
the target vessel.
24. The endoluminal prosthesis of claim 21, wherein two openings
are formed in the second portion of the main graft body, the two
openings being separated by an angle between approximately 130
degrees and approximately 170 degrees.
25. The endoluminal prosthesis of claim 21, wherein the second
portion is located between the first and third portions.
26. The endoluminal prosthesis of claim 21, wherein a distance
between end portions of the main graft body is greater than a
distance between opposing end portions of the first support portion
and the second support portion.
27. A method of deploying an endoluminal prosthesis, comprising:
advancing a catheter supporting the endoluminal prosthesis therein
through a patient's vasculature to a target vessel location,
wherein: the prosthesis has a main graft body comprising a first
portion, a second portion, and a third portion; and the second
portion of the main graft body has a cross-sectional size that is
significantly larger than a cross-sectional size of the first
portion and the third portion, and also significantly larger than a
cross-sectional size of the target vessel; advancing one or more
catheters through one or more fenestrations formed in the main
graft body and into one or more branch vessels in the patient's
vasculature; at least partially expanding at least the second
portion of the main graft body; and substantially aligning the one
or more fenestrations formed within the second portion of the main
graft body with the one or more branch vessels by moving the one or
more fenestrations in a circumferential and/or axial direction
toward an ostium of the one or more branch vessels.
28. The method of deploying an endoluminal prosthesis of claim 27,
wherein at least partially expanding at least a portion of the
prosthesis comprises removing a radial restraint surrounding the
prosthesis and permitting the prosthesis to self-expand.
29. The method of deploying an endoluminal prosthesis of claim 27,
wherein the first portion of the main graft body is attached to the
first stent portion and wherein the third portion of the main graft
body is attached to the second stent portion; and the second
portion of the main graft body is not directly attached to the
first stent portion, the second stent portion, or any other
internal support structure.
30. The method of deploying an endoluminal prosthesis of claim 27,
wherein the cross-sectional size of the second portion is
approximately 30% larger than the cross-sectional size of the
target vessel.
31. The method of deploying an endoluminal prosthesis of claim 27,
wherein the cross-sectional size of the second portion is from
approximately 20% to approximately 40% larger than the
cross-sectional size of the target vessel.
32. The method of deploying an endoluminal prosthesis of claim 27,
wherein two openings are formed in the second portion of the main
graft body, the two openings being separated by an angle between
approximately 130 degrees and approximately 170 degrees.
33. The method of deploying an endoluminal prosthesis of claim 32,
wherein the two openings are separated by approximately 150
degrees.
34. The method of deploying an endoluminal prosthesis of claim 27,
further comprising advancing a bare or covered stent through the
one or more fenestrations.
35. The method of deploying an endoluminal prosthesis of claim 27,
wherein the first and second stent portions are interconnected by
one or more connectors spanning at least the second portion of the
graft.
Description
PRIORITY INFORMATION AND INCORPORATION BY REFERENCE
[0001] This application claims priority benefit under 35 U.S.C.
.sctn.119(e) of Provisional Application 61/173,485 filed Apr. 28,
2009, Provisional Application 61/228,048 filed Jul. 23, 2009, and
Provisional Application 61/231,898 filed Aug. 6, 2009, which
applications are hereby incorporated by reference as if fully set
forth herein. Additionally, U.S. patent application Ser. No.
12/496,446, filed on Jul. 1, 2009 (entitled "CATHETER SYSTEM AND
METHODS OF USING SAME"), U.S. patent application Ser. No.
12/390,346, filed on Feb. 20, 2009 (entitled "DESIGN AND METHOD OF
PLACEMENT OF A GRAFT OR GRAFT SYSTEM"), U.S. patent application
Ser. No. 12/101,863, filed on Apr. 11, 2008 (entitled "BIFURCATED
GRAFT DEPLOYMENT SYSTEMS AND METHODS"), U.S. Pat. No. 6,077,296,
filed on Mar. 4, 1998 (entitled "ENDOLUMINAL VASCULAR PROSTHESIS"),
U.S. Pat. No. 6,953,475, filed on Sep. 30, 2003 (entitled
"BIFURCATION GRAFT DEPLOYMENT CATHETER"), and U.S. Pat. No.
7,520,895, filed on Apr. 8, 2002 (entitled "SELF EXPANDING
BIFURCATED ENDOVASCULAR PROSTHESIS") are also hereby incorporated
by reference in their entireties as if fully set forth herein.
BACKGROUND OF THE DISCLOSURE
[0002] 1. Technical Field
[0003] The present invention relates to endoluminal vascular
prostheses and methods of deploying such prostheses, and, in one
application, to endoluminal vascular prostheses for use in the
treatment of vessels with branches.
[0004] 2. Description of the Related Art
[0005] An abdominal aortic aneurysm is a sac caused by an abnormal
dilation of the wall of the aorta, a major artery of the body, as
it passes through the abdomen. The abdomen is that portion of the
body that lies between the thorax and the pelvis. It contains a
cavity, known as the abdominal cavity, separated by the diaphragm
from the thoracic cavity and lined with a serous membrane, the
peritoneum. The aorta is the main trunk, or artery, from which the
systemic arterial system proceeds. It arises from the left
ventricle of the heart, passes upward, bends over and passes down
through the thorax and through the abdomen to about the level of
the fourth lumbar vertebra, where it divides into the two common
iliac arteries.
[0006] The aneurysm usually arises in the infrarenal portion of the
diseased aorta, for example, below the kidneys. When left
untreated, the aneurysm may eventually cause rupture of the sac
with ensuing fatal hemorrhaging in a very short time. High
mortality associated with the rupture led initially to
transabdominal surgical repair of abdominal aortic aneurysms.
Surgery involving the abdominal wall, however, is a major
undertaking with associated high risks. There is considerable
mortality and morbidity associated with this magnitude of surgical
intervention, which in essence involves replacing the diseased and
aneurysmal segment of blood vessel with a prosthetic device which
typically is a synthetic tube, or graft, usually fabricated of
polyester, urethane, Dacron.TM., Teflon.TM., or other suitable
material.
[0007] To perform the surgical procedure requires exposure of the
aorta through an abdominal incision which can extend from the rib
cage to the pubis. The aorta must typically be closed both above
and below the aneurysm, so that the aneurysm can then be opened and
the thrombus, or blood clot, and arteriosclerotic debris removed.
Small arterial branches from the back wall of the aorta are tied
off The Dacron.TM. tube, or graft, of approximately the same size
of the normal aorta is sutured in place, thereby replacing the
aneurysm. Blood flow is then reestablished through the graft. It is
necessary to move the intestines in order to get to the back wall
of the abdomen prior to clamping off the aorta.
[0008] If the surgery is performed prior to rupturing of the
abdominal aortic aneurysm, the survival rate of treated patients is
markedly higher than if the surgery is performed after the aneurysm
ruptures, although the mortality rate is still quite high. If the
surgery is performed prior to the aneurysm rupturing, the mortality
rate is typically slightly less than 10%. Conventional surgery
performed after the rupture of the aneurysm is significantly
higher, one study reporting a mortality rate of 66.5%. Although
abdominal aortic aneurysms can be detected from routine
examinations, the patient does not experience any pain from the
condition. Thus, if the patient is not receiving routine
examinations, it is possible that the aneurysm will progress to the
rupture stage, wherein the mortality rates are significantly
higher.
[0009] Disadvantages associated with the conventional, prior art
surgery, in addition to the high mortality rate include the
extended recovery period associated with such surgery; difficulties
in suturing the graft, or tube, to the aorta; the loss of the
existing aorta wall and thrombosis to support and reinforce the
graft; the unsuitability of the surgery for many patients having
abdominal aortic aneurysms; and the problems associated with
performing the surgery on an emergency basis after the aneurysm has
ruptured. A patient can expect to spend from one to two weeks in
the hospital after the surgery, a major portion of which is spent
in the intensive care unit, and a convalescence period at home from
two to three months, particularly if the patient has other
illnesses such as heart, lung, liver, and/or kidney disease, in
which case the hospital stay is also lengthened. Since the graft
must typically be secured, or sutured, to the remaining portion of
the aorta, it is many times difficult to perform the suturing step
because the thrombosis present on the remaining portion of the
aorta, and that remaining portion of the aorta wall may be friable,
or easily crumbled.
[0010] Since many patients having abdominal aortic aneurysms have
other chronic illnesses, such as heart, lung, liver, and/or kidney
disease, coupled with the fact that many of these patients are
older, the average age being approximately 67 years old, these
patients are not ideal candidates for such major surgery.
[0011] More recently, a significantly less invasive clinical
approach to aneurysm repair, known as endovascular grafting, has
been developed. Parodi, et al. provide one of the first clinical
descriptions of this therapy. Parodi, J. C., et al., "Transfemoral
Intraluminal Graft Implantation for Abdominal Aortic Aneurysms," 5
Annals of Vascular Surgery 491 (1991). Endovascular grafting
involves the transluminal placement of a prosthetic arterial graft
in the endoluminal position (within the lumen of the artery). By
this method, the graft is attached to the internal surface of an
arterial wall by means of attachment devices (expandable stents),
typically one above the aneurysm and a second stent below the
aneurysm.
[0012] Stents can permit fixation of a graft to the internal
surface of an arterial wall without sewing or an open surgical
procedure. Expansion of radially expandable stents is
conventionally accomplished by dilating a balloon at the distal end
of a balloon catheter. In U.S. Pat. No. 4,776,337, for example,
Palmaz describes a balloon-expandable stent for endovascular
treatments. Also known are self-expanding stents, such as described
in U.S. Pat. No. 4,655,771 to Wallsten.
[0013] In certain conditions, the diseased region of the blood
vessels can extend across branch vessels. The blood flow into these
branch vessels is critical for the perfusion of the peripheral
regions of the body and vital organs. Many arteries branch off the
aorta. For example, the carotid arteries supply blood into the
brain, the renal arteries supply blood into the kidneys, the
superior mesenteric artery ("SMA") supplies the pancreas, the
hypogastric arteries supply blood to the reproductive organs, and
the subclavian arteries supply blood to the arms. When the aorta is
diseased, the branch vessels may also be affected. Thoracic aortic
aneurysms may involve the subclavian and carotid arteries,
abdominal aneurysms may involve the SMA, renal and hypogastric
arteries. Aortic dissections may involve all branch vessels
mentioned above. When this occurs, it may be detrimental to implant
a conventional tubular graft in this location of the aorta or the
blood vessel, since such a graft may obstruct the flow of blood
from the aorta into the branches.
[0014] Grafts and graft systems are typically used to treat
aneurysms in the aorta or in other blood vessels. These grafts can
be positioned within the aorta or other blood vessels at the
location of an aneurysm and, generally speaking, can provide a
synthetic vessel wall that channels the flow of blood through the
diseased portion of the blood vessel. As such, the grafts are
typically fluid impermeable so that no blood can flow through the
walls of the graft. Rather, the blood is channeled through the
central passageway defined by the graft.
[0015] Thus, there is a need to place endoluminal prostheses in the
aorta without obstructing critical branch vessels. The embodiments
of the endoluminal prostheses disclosed herein provide a solution
to the problems described above.
SUMMARY OF SOME EXEMPLIFYING EMBODIMENTS
[0016] Some embodiments of the endoluminal prostheses disclosed
(directly and/or by incorporation by reference) herein pertain to
designs and methods of placement of a branch graft or branch graft
system having lateral openings in the main graft. The main graft
can be positioned within the main blood vessel such as the aorta so
that the lateral openings (also referred to herein as
fenestrations) can be aligned with the branch blood vessels, to
allow blood to flow through the openings in the main graft and into
the branch vessels. Because the axial and angular position of the
branch blood vessels can vary from one patient's anatomy to the
next, the embodiments of the graft systems disclosed herein can
allow a surgeon to adjust the position of the fenestrations so as
to align the fenestrations with the branch vessels so that blood
flow through the branch vessels is not obstructed by the main
graft.
[0017] The branch graft system can comprise a tubular expandable
main body and at least one fenestration or at least one branch
graft at any desired location. The main graft body and/or the
branch graft can be made from an expandable material, such as but
not limited to ePTFE. In some embodiments, the main graft can have
two fenestrations or branch grafts formed therein at generally
diametrically opposed locations or at positions that are offset
from the diametrically opposed positions. Depending on the
particular patient's anatomy, other cut-outs, scallops, or
fenestrations, such as but not limited to a fenestration for the
superior mesenteric artery ("SMA"), can be formed in the main graft
depending on the patient's anatomy and position of the graft.
[0018] Some embodiments of the main graft body can have a tubular
shape and can have a diameter that can be significantly larger than
the diameter of the target vessel into which the graft is intended
to be deployed. As will be described in greater detail below, the
oversized diameter of the main graft can provide excess or slack
graft material in the main graft to allow the fenestrations to each
be moved in a plurality of axial and/or angular directions so that
the fenestrations can be aligned with the branch arteries.
[0019] In some embodiments, one or more branch grafts can be
supported by the main graft body adjacent to the one or more
openings that can be formed in the main graft body. The diameter of
each branch graft can be sufficiently small so as to allow each
branch graft to be manipulated into the desired vascular position
by moving the branch graft over a guidewire. The branch graft can
be expanded to the diameter of the branch vessel by mechanical
means, which can be a dilation balloon.
[0020] Some embodiments are directed to endoluminal prostheses,
comprising a first stent portion and a second stent portion, a main
graft body comprising a first portion, a second portion, and a
third portion, the second portion having a cross-sectional size
that is significantly larger than a cross-sectional size of the
first portion or the third portion, and also significantly larger
than a cross-sectional size of the target vessel, and one or more
openings formed in the second portion of the main graft body. In
some embodiments, the first portion of the main graft body can be
attached to the first stent portion and the third portion of the
main graft body can be attached to the second stent portion.
Further, prosthesis can be configured such that the second portion
of the main graft body is not directly attached to the first stent
portion, the second stent portion, or any other internal support
structure, or so that the second portion has a minimal number of
attachment points thereto.
[0021] Some embodiments are directed to endoluminal prostheses,
comprising a main graft body comprising a first portion, a second
portion, and a third portion, the second portion having a
cross-sectional size that is significantly larger than a
cross-sectional size of the first portion or the third portion, and
also significantly larger than a cross-sectional size of the target
vessel, and one or more openings formed in the second portion of
the main graft body. In some embodiments, the first portion of the
main graft body can be radially supported by a first support member
and the third portion of the main graft body can be radially
supported by a second support member. In some embodiments, the
second portion of the main graft body can be free of radial support
from a stent or other support member.
[0022] Some embodiments are directed to endoluminal prostheses,
comprising a main graft body comprising a first portion, a second
portion, and a third portion, a support member positioned within
the main graft body, the support member having a first support
portion, a second support portion, and a third support portion, and
one or more openings formed in the second portion of the main graft
body. In some embodiments, the first portion of the main graft body
can be attached to the first support portion of the support member
at a first number of attachment points, the second portion of the
main graft body can be attached to the second support portion of
the support member at a second number of attachment points, and the
third portion of the main graft body can be attached to the third
support portion of the support member at a third number of
attachment points. Without limitation, the third number of
attachment points can be less than the first number of attachment
points and the third number of attachment points. In some
embodiments, the entirety of the second portion can have a
cross-sectional size that is significantly larger than a
cross-sectional size of the first portion or the third portion, and
also significantly larger than a cross-sectional size of the target
vessel.
[0023] Some embodiments or arrangements are directed to methods for
deploying an endoluminal prosthesis, comprising advancing a
catheter supporting the endoluminal prosthesis therein through a
patient's vasculature to a target vessel location, advancing one or
more catheters through one or more fenestrations foamed in the main
graft body and into one or more branch vessels in the patient's
vasculature, at least partially expanding at least the second
portion of the main graft body, and substantially aligning the one
or more fenestrations formed within the second portion of the main
graft body with the one or more branch vessels by moving the one or
more fenestrations in a circumferential and/or axial direction
toward the ostium of the one or more branch vessels. In some
embodiments or arrangements, the prosthesis can have a main graft
body comprising a first portion, a second portion, and a third
portion. Further, in some embodiments or arrangements, the second
portion of the main graft body can have a cross-sectional size that
is significantly larger than a cross-sectional size of the first
portion and the third portion, and also significantly larger than a
cross-sectional size of the target vessel.
[0024] Some embodiments or arrangements are directed to methods for
deploying a graft in a patient's blood vessel having at least a
first branch blood vessel, comprising advancing a delivery catheter
into a blood vessel, the delivery catheter supporting a fenestrated
prosthesis comprising a main graft body therein, and exposing at
least one branch sheath. The branch sheath can be positioned within
the delivery catheter so as to extend from a main lumen of the
prosthesis through a first opening formed through a wall of the
prosthesis. Some embodiments can further comprise advancing an
angiographic catheter into the branch sheath and cannulating a
first target branch vessel before expanding the main graft body of
the prosthesis.
[0025] Some embodiments or arrangements are directed to methods for
deploying a fenestrated prosthesis in a patient's blood vessel
having at least a first branch blood vessel, comprising advancing a
delivery catheter into a blood vessel, exposing at least one guide
sheath, the guide sheath being positioned within the delivery
catheter so as to extend from a main lumen of the prosthesis
through a first opening formed through a wall of the prosthesis,
and advancing an angiographic catheter through the guide sheath and
cannulating a first target branch vessel before completely removing
the second restraint. In some embodiments, the delivery catheter
can support the fenestrated prosthesis having a main graft body and
at least one fenestration extending through the main graft body, a
first restraint restraining a proximal portion of the prosthesis,
and a second restraint restraining a distal portion of the
prosthesis, the distal portion of the prosthesis being closer to a
proximal portion of the delivery catheter than the proximal portion
of the prosthesis.
[0026] Some embodiments or arrangements are directed to methods for
deploying a fenestrated prosthesis in a patient's blood vessel
having at least a first branch blood vessel, comprising advancing a
delivery catheter into a blood vessel, exposing at least one guide
sheath, the guide sheath being positioned within the delivery
catheter so as to extend from a main lumen of the prosthesis
through a first opening formed through a wall of the prosthesis,
and advancing the guide sheath into a first target branch vessel
before completely removing the second restraint. In some
embodiments, the delivery catheter can support the fenestrated
prosthesis, and the fenestrated prosthesis can have a main graft
body and at least one fenestration therein, a first restraint
restraining a proximal portion of the prosthesis, and a second
restraint restraining a distal portion of the prosthesis, the
distal portion of the prosthesis being closer to a proximal portion
of the delivery catheter than the proximal portion of the
prosthesis,
[0027] Some embodiments or arrangements are directed to delivery
systems for deploying an endoluminal prosthesis, comprising a first
restraint configured to restrain a portion of the prosthesis, a
second restraint configured to restrain a second portion of the
prosthesis, a first opening through a wall of the prosthesis, a
first guide sheath extending from a proximal end of the delivery
system into a main lumen of the endoluminal prosthesis and through
the first opening in the wall of the prosthesis, a first stent
configured to support the first portion of the endoluminal
prosthesis, and a second stent configured to support the second
portion of the endoluminal prosthesis, wherein the guide sheath is
moveable before removing the first and second restraints. The first
opening can be positioned between the first and second
portions.
[0028] Some embodiments or arrangements are directed to endoluminal
prostheses comprising a main graft body defining a flow lumen
therethrough, a first opening passing through a wall of the main
graft body, and a first support member supported by the main graft
body and overlapping an edge of the first opening, the first
support member being configured to increase the tear resistance of
the main graft body adjacent to the first opening.
[0029] Some embodiments or arrangements are directed to methods for
forming an endoluminal prosthesis having at least one reinforced
fenestration in a main portion thereof, comprising forming a graft
body having a tubular main body portion, forming a first opening
through a wall of the main body portion, the first opening having a
first state in which the first opening is substantially unstretched
and a second state in which the first opening is stretched so that
a size of the first opening increases, advancing a tubular member
partially through the first opening, and fastening a first end
portion and a second end portion of the tubular member to the wall
of the main body portion adjacent to the first opening so that the
tubular member completely overlaps an edge of the first
opening.
[0030] In any of the embodiments disclosed (directly or by
incorporation by reference) herein, main graft body, branch grafts,
or any other component of the endoluminal prostheses or deployment
systems disclosed herein can have at least one radiopaque suture or
marker attached thereto to assist with the placement of such
components.
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] FIG. 1 is a partial section view of a patient's vasculature
illustrating an embodiment of an endoluminal prosthesis deployed in
the desired position within the patient's vasculature.
[0032] FIG. 2 is a side view of the endoluminal prosthesis
illustrated in FIG. 1.
[0033] FIG. 3 is a cross-sectional view of the embodiment of the
endoluminal prosthesis deployed in the patient's anatomy, taken
through line 3-3 in FIG. 1, before the fenestrations have been
aligned with the respective branch vessels.
[0034] FIG. 4 is a cross-sectional view of the embodiment of the
endoluminal prosthesis deployed in the patient's anatomy, taken
through line 3-3 in FIG. 1, after the fenestrations have been
aligned with the respective branch vessels.
[0035] FIG. 5 is a partial section view of a patient's vasculature
illustrating another embodiment of an endoluminal prosthesis
deployed in the desired position within the patient's
vasculature.
[0036] FIGS. 6-12 are side views of additional embodiments of
endoluminal prostheses.
[0037] FIG. 12A is an enlarged side view of the embodiment of the
endoluminal prosthesis illustrated in FIG. 12, defined by curve
12A-12A in FIG. 12.
[0038] FIG. 13 is a side view of another embodiment of an
endoluminal prosthesis.
[0039] FIG. 14 is a top view of the embodiment of the endoluminal
prosthesis shown in FIG. 14.
[0040] FIG. 15 is a side view of another embodiment of an
endoluminal prosthesis.
[0041] FIG. 16 is an enlargement of a portion of the embodiment of
an endoluminal prosthesis shown in FIG. 15, defined by curve 16-16,
illustrating the adjustability of a branch graft.
[0042] FIG. 17 is a side view of another embodiment of an
endoluminal prosthesis with guidewires advanced through each of the
branch grafts.
[0043] FIG. 18 is a side view of the embodiment of the endoluminal
prosthesis shown in FIG. 17 with guidewires advanced through each
of the branch grafts, showing the endoluminal prosthesis being
loaded within a delivery catheter.
[0044] FIG. 19 is a side view of the embodiment of the endoluminal
prosthesis shown in FIG. 17 with guidewires advanced through each
of the branch grafts, showing the endoluminal prosthesis fully
loaded within a delivery catheter and being advanced along
guidewires pre-wired in the patient's vasculature.
[0045] FIG. 20 is a side view of another embodiment of a delivery
catheter that can be used to deploy at least some of the
embodiments of the endoluminal prostheses disclosed herein, showing
the endoluminal prosthesis being loaded within a delivery
catheter.
[0046] FIG. 21 is an enlarged side view of a portion of the
embodiment of a delivery catheter illustrated in FIG. 20, showing
the endoluminal prosthesis loaded within a delivery catheter.
[0047] FIG. 22A is a section view of an embodiment of a distal tip
that can be used with the embodiment of the delivery catheter that
is illustrated in FIG. 20, taken through line 22A-22A in FIG.
20.
[0048] FIG. 22B is a section view of another embodiment of a distal
tip that can be used with the embodiment of the delivery catheter
that is illustrated in FIG. 20, taken through line 22B-22B in FIG.
20.
[0049] FIG. 23A is a section view of the embodiment of the delivery
catheter shown in FIG. 20, taken through line 23A-23A in FIG.
20.
[0050] FIG. 23B is a section view of the embodiment of the delivery
catheter shown in FIG. 20, taken through line 23B-23B in FIG.
20.
[0051] FIG. 24 is a side view of another embodiment of a delivery
catheter showing a delivery catheter being advanced distally past a
bifurcated graft and showing guidewires being advanced into the
renal arteries.
[0052] FIG. 25 is a side view of the embodiment of the delivery
catheter shown in FIG. 24, showing biased guidewires being advanced
into the renal arteries.
[0053] FIG. 26 is a side view of the embodiment of the delivery
catheter shown in FIG. 24, showing the embodiment of the
endoluminal prosthesis being deployed within the target vessel
region.
[0054] FIG. 27 is a side view of the embodiment of the delivery
catheter shown in FIG. 24, showing the endoluminal prosthesis after
the distal portion of the endoluminal prosthesis has been deployed
within the bifurcated prosthesis.
[0055] FIG. 28 is a side view of the embodiment of the delivery
catheter shown in FIG. 24, showing the endoluminal prosthesis after
the distal portion of the endoluminal prosthesis has been deployed
within the bifurcated prosthesis.
[0056] FIG. 29 is a side view of another embodiment of a delivery
catheter showing a delivery catheter being advanced distally past
renal arteries in the thoracic aorta region of a patient's
vasculature.
[0057] FIG. 30 is a side view of an endoluminal prosthesis that can
be deployed using the embodiment of the delivery catheter shown in
FIG. 29.
[0058] FIG. 31 is a section view of an embodiment of a guidewire,
showing the guidewire in a collapsed configuration.
[0059] FIG. 32 is a section view of the embodiment of the guidewire
shown in FIG. 31, showing the guidewire in an expanded
configuration.
[0060] FIGS. 33 and 34 illustrate a pair of guidewires positioned
within the patient's vasculature such that the distal end portions
of the guidewires are secured within the patient's branch
vessels.
[0061] FIG. 35 is a side view of another embodiment of a guidewire,
showing the guidewire in an expanded configuration.
[0062] FIG. 36 is a side view of another embodiment of a guidewire,
showing the guidewire in an expanded configuration.
[0063] FIG. 37 is a section view of another embodiment of a
guidewire, showing the guidewire in an expanded configuration.
[0064] FIG. 38 is a side view of another embodiment of an
endoluminal prosthesis, showing the branch grafts in an inverted
position inside the main body of the prosthesis.
[0065] FIG. 39 is a side view of the embodiment of the prosthesis
shown in FIG. 38, showing the branch grafts in an inverted position
inside the prosthesis and showing an embodiment of an angiographic
catheter being advanced through each of the inverted branch grafts
and the fenestrations.
[0066] FIG. 40 is a section view of the embodiment of the
prosthesis shown in FIG. 40, taken through line 40-40 in FIG.
39.
[0067] FIG. 41 is a section view of the embodiment of the
prosthesis shown in FIG. 40, taken through line 41-41 in FIG.
39.
[0068] FIG. 42 is a section view of the embodiment of the
prosthesis shown in FIG. 40, after the branch grafts have been
advanced through the fenestrations in the main body of the
embodiment of the prosthesis shown in FIG. 38.
[0069] FIG. 43A is a side view of another embodiment of a catheter
system comprising an embodiment of an introducer catheter and an
embodiment of a delivery catheter.
[0070] FIG. 43B is a perspective view of the embodiment of a
catheter system illustrated in FIG. 43A, showing the outer sheath
in a partially retracted position.
[0071] FIG. 44 is a perspective view of the embodiment of the
introducer catheter shown in FIG. 43.
[0072] FIG. 45 is an exploded view of the embodiment of the
introducer catheter shown in FIG. 43.
[0073] FIG. 46 is a perspective view of the embodiment of the
delivery catheter shown in FIG. 43.
[0074] FIG. 47 is an exploded view of the embodiment of the
delivery catheter shown in FIG. 43.
[0075] FIG. 48 is a section view of a portion of the embodiment of
the delivery catheter shown in FIG. 43, defined by curve 48-48
shown in FIG. 43A.
[0076] FIG. 49A is a section view of the embodiment of the delivery
catheter shown in FIG. 43, defined by the line 49A-49A shown in
FIG. 48.
[0077] FIG. 49B is a section view of the embodiment of the delivery
catheter shown in FIG. 43, defined by the line 49B-49B shown in
FIG. 48.
[0078] FIG. 50 is a side view of the embodiment of the catheter
system shown in FIG. 43, showing the outer sheath in a partially
retracted position.
[0079] FIG. 51 is an enlarged side view of the embodiment of the
catheter system shown in FIG. 43, defined by curve 51-51 shown in
FIG. 50, showing the outer sheath in a partially retracted
position.
[0080] FIG. 52 is an enlarged side view of the embodiment of the
catheter system shown in FIG. 43, defined by curve 52-52 shown in
FIG. 50, showing the outer sheath in a partially retracted position
and the proximal sheath in a partially advanced position.
[0081] FIG. 53 is a side view of the embodiment of the catheter
system shown in FIG. 43, showing the outer sheath in a partially
retracted position and the embodiment of one branch sheath and one
push catheter in a partially advanced position.
[0082] FIG. 54 is a section view of a portion of a patient's
vasculature, showing the embodiment of the delivery catheter
illustrated in FIG. 43A being advanced through a patient's
abdominal aorta.
[0083] FIG. 55 is a section view of a portion of a patient's
vasculature, showing the embodiment of the delivery catheter
illustrated in FIG. 43A and an angiographic catheter being advanced
through a branch sheath of the delivery catheter toward a branch
vessel.
[0084] FIG. 56 is a section view of a portion of a patient's
vasculature, showing the embodiment of the delivery catheter
illustrated in FIG. 43A and the branch sheaths of the delivery
catheter being advanced into a patient's branch arteries.
[0085] FIG. 57 is a section view of a portion of a patient's
vasculature, showing an embodiment of a distal sheath of the
embodiment of the delivery catheter illustrated in FIG. 43A being
advanced to deploy a proximal portion of the prosthesis.
[0086] FIG. 58 is a section view of a portion of a patient's
vasculature, showing an embodiment of a peelable sheath of the
embodiment of the delivery catheter illustrated in FIG. 43A being
removed to deploy a distal portion of the prosthesis.
[0087] FIG. 59 is a section view of a portion of a patient's
vasculature, showing an embodiment of a push catheter of the
embodiment of the delivery catheter illustrated in FIG. 43A
advancing an inner wall of the prosthesis adjacent to a
fenestration toward an ostium of the target branch vessel.
[0088] FIG. 60 is a section view of a portion of a patient's
vasculature, showing an embodiment of a branch stent being advanced
into the target branch vessel.
[0089] FIG. 61 is a section view of a portion of a patient's
vasculature, showing the embodiment of the branch stent of FIG. 60
being expanded in the target branch vessel and flared.
[0090] FIGS. 62A and 62B are perspective views of an embodiment of
a prosthesis having one or more fenestrations therein, the graft
being shown in dashed lines in FIG. 62B for clarity.
[0091] FIG. 63 is a top view of the embodiment of the prosthesis of
FIG. 62.
[0092] FIG. 64 is an enlarged view of a portion of the embodiment
of the prosthesis of FIG. 62, defined by curve 64-64 of FIG.
62B.
[0093] FIG. 65 is a partially exploded schematic representation of
the prosthesis embodiment shown in FIG. 62.
[0094] FIG. 66 is an enlarged side view of the embodiment of the
fenestration shown in FIG. 65, defined by curve 66-66 of FIG.
65.
[0095] FIG. 67 is an enlarged section view of the embodiment of the
fenestration illustrated in FIG. 65, showing the end portions of
the embodiment of the tubular member being pulled back against the
graft.
[0096] FIG. 68 is an enlarged section view of the embodiment of the
fenestration shown in FIG. 65, showing the end portions of the
embodiment of the tubular member stitched to the graft.
[0097] FIG. 69 is a side view of the embodiment of the stent shown
in FIG. 62, perpendicular to an axis projecting through the
fenestration.
[0098] FIG. 70 is a side view of the embodiment of the stent shown
in FIG. 62, along an axis projecting through the fenestration.
[0099] FIGS. 71-85 are side views of additional embodiments of
prostheses having or more enlarged portions and one or more
fenestrations therein.
[0100] FIG. 86 illustrates calculations regarding the theoretical
axial adjustability of at least some embodiments of the grafts
disclosed herein.
[0101] FIG. 87 illustrates calculations regarding the theoretical
angular or radial adjustability of at least some embodiments of the
grafts disclosed herein.
DETAILED DESCRIPTION OF SOME EXEMPLIFYING EMBODIMENTS
[0102] The following detailed description is now directed to
certain specific embodiments of the disclosure. In this
description, reference is made to the drawings wherein like parts
are designated with like numerals throughout the description and
the drawings.
[0103] Some embodiments described herein are directed to systems,
methods, and apparatuses to treat lesions, aneurysms, or other
defects in the aorta, including, but not limited to, the thoracic,
ascending, and abdominal aorta, to name a few. However, the
systems, methods, and apparatuses may have application to other
vessels or areas of the body, or to other fields, and such
additional applications are intended to form a part of this
disclosure. For example, it will be appreciated that the systems,
methods, and apparatuses may have application to the treatment of
blood vessels in animals. In short, the embodiments and/or aspects
of the endoluminal prosthesis systems, methods, and apparatuses
described herein can be applied to other parts of the body or may
have other applications apart from the treatment of the thoracic,
ascending, and abdominal aorta. And, while specific embodiments may
be described herein with regard to particular portions of the
aorta, it is to be understood that the embodiments described can be
adapted for use in other portions of the aorta or other portions of
the body and are not limited to the aortic portions described.
[0104] As will be described, any of the graft embodiments disclosed
herein can be configured to have excess or slack graft material in
at least a portion thereof relative to the stent or support member
which supports the graft. In some embodiments, without limitation,
the excess or slack material can result from either an enlarged
diametric portion of the graft, excess length of the graft material
relative to a stent or other support structure, or a combination of
both the enlarged diametric portion of the graft and excess length
of the graft material. For example, without limitation, the excess
graft material can form a bulge or other enlargement in the graft
in the approximate location of one or more fenestrations formed
through the graft material. The excess or slack material along the
circumference of the graft (for example, without limitation, in the
enlarged portion of the graft) can allow for circumferential and/or
axial movement of the graft material and, hence, can allow for
circumferential and/or axial movement of the one or more
fenestrations, relative to the stent and the ostium of the
patient's branch vessels. Therefore, in some embodiments, the
diameter of the graft at and/or adjacent to the location of one or
more fenestrations through the graft material can be larger than
the local diameter of the target vessel. Similarly, in some
embodiments, the diameter of the graft at and/or adjacent to the
location of one or more fenestrations can be larger than the
diameter of the non-enlarged portion of the graft material.
[0105] For example, any of the embodiments disclosed herein can be
configured such that the graft has an enlarged or excess slack
portion at or adjacent to the location of the fenestrations,
wherein such enlarged or excess slack portion is free of attachment
points or has only a minimal number of attachment points to the
stent or support structure radially adjacent to the enlarged or
excess slack portion. In some embodiments, this can result in both
freedom of circumferential and axial movement of the fenestrations,
thereby improving the positional adjustability of the
fenestrations. In some embodiments, the enlarged or excess slack
portions of the graft can be radially unsupported by the stent or
support member, or can be supported by a stent or support member or
by connectors connecting support members positioned axially
adjacent to the enlarged or excess slack portion. Accordingly, any
of the graft embodiments described herein can be configured to have
excess circumferential or longitudinal material at any portion of
the graft to increase the positional adjustability of one or more
fenestrations formed in the graft.
[0106] Further, any of the graft embodiments disclosed herein,
including those with diametrically enlarged portions, can have
excess graft material in an axial direction. The excess or slack
material along the length of the graft can increase the
circumferential and/or axial movement of the graft material
adjacent to the one or more fenestrations formed in the graft
material. Accordingly, in some embodiments, the length of the graft
material between the proximal and distal attachment points to the
stent can be longer than that of the stent between the proximal and
distal attachment points. Or, in some embodiments, the graft
material in a mid portion of the graft, including on either side of
the enlarged portion, can have an increased length relative to the
stent adjacent to such graft portion.
[0107] As can be seen in the table of measurement data below, the
relative position of a patient's left and right renal arteries, a
patient's superior mesenteric artery ("SMA"), and a patient's
celiac artery can vary widely. For this reason, the adjustability
of one or more fenestrations within the graft material can greatly
improve the positional ease and accuracy of the fenestrations
relative to the patient's branch arteries during deployment of the
graft.
TABLE-US-00001 Measurement Description Average Minimum Maximum
Distance from right 14.0 mm -8.9 mm 42.9 mm renal to SMA Distance
from left 16.9 mm -8.0 mm 47.0 mm renal to SMA Distance from -10.6
mm -36.0 mm 23.6 mm celiac to SMA Angle from right 72.3 degrees
32.1 degrees 115.9 degrees renal to SMA Angle from left 79.0
degrees 30.9 degrees 118.4 degrees renal to SMA Angle between left
and 151.3 degrees right renal arteries
[0108] FIG. 1 is a partial section view of a patient's vasculature
illustrating an embodiment of an endoluminal prosthesis deployed in
the desired position within the patient's vasculature. Although the
prostheses disclosed herein can be adapted for deployment in any
suitable vessels in the body, some embodiments are described as
being deployed in particular vessels or vascular regions within a
patient's body. However, the particular prostheses illustrated are
not limited to deployment in only one particular vessel or vascular
region. In some embodiments, the embodiments shown can be adapted
for deployment in other suitable vessels within a patient's body,
including the aorta, thoracic artery, renal arteries, iliac
arteries, etc.
[0109] As an example, with reference to FIG. 1, an embodiment of an
endoluminal prosthesis is shown deployed in a patient's aorta 10.
An anuerysmic sac 10A is also shown. For reference, also
illustrated are a patient's first and second renal arteries 12, 14,
respectively, and a patient's ipsilateral and contralateral iliac
arteries 16, 18, respectively. FIG. 2 is a side view of the
endoluminal prosthesis 20 illustrated in FIG. 1. The embodiment of
the endoluminal prosthesis 20 illustrated in FIGS. 1 and 2 can have
a main graft body 22, a first fenestration 24, and a second
fenestration 26. In some embodiments, as in the illustrated
embodiment, the main graft can be a bifurcated graft having a first
bifurcated branch 28 and a second bifurcated branch 30 for
placement in the ipsilateral and contralateral iliac arteries.
[0110] In some embodiments, the main graft body 22 can have a
generally cylindrical, tubular shape. The endoluminal prosthesis 20
can be formed from any suitable material, such as, but not limited
to, ePTFE. Some embodiments of the endoluminal prosthesis 20 can be
formed from an expandable material. The endoluminal prosthesis 20
can be formed such that the main graft body 22 can be significantly
larger than the target vessel into which the main graft body 22 is
to be deployed. As illustrated in FIG. 1, the target vessel can be
the aortic artery, and the endoluminal prosthesis can be deployed
so as to span across an aneurysm in the abdominal aortic.
[0111] In any of the graft embodiments disclosed herein, the
diameter of the graft body (such as without limitation the main
graft body 22) or an enlarged portion of any embodiment of a graft
body disclosed herein can be approximately 30% larger than the
diameter of the target vessel or the diameter of the non-enlarged
portion of the graft body. In some embodiments, the diameter of the
graft body (such as without limitation the main graft body 22) or
an enlarged portion of any embodiment of a graft body disclosed
herein can be less than approximately 20%, or from approximately
20% to approximately 50% or more, or from approximately 25% to
approximately 40% larger than the target vessel or the diameter of
the non-enlarged portion of the graft body, or to or from any
values within these ranges.
[0112] Further, in any of the graft embodiments disclosed herein,
at least a portion of the graft material adjacent to the one or
more fenestrations or openings can be free to translate in a
circumferential or axial direction relative to the stent that the
graft is supported by. For example, without limitation, particular
portions such as the end portions of the graft material can be
sutured or otherwise fastened to the stent, while a mid portion of
the graft having one or more fenestrations therethrough can be
unattached to the stent so that such mid portion can be free to
translate relative to the stent and, hence, permit the
adjustability of the fenestrations relative to the stent. In this
configuration, the fenestrations can be adjusted to align with the
ostium of the patient's branch vessels.
[0113] As one non-limiting example, the diameter of the main graft
body 22 configured for placement in an approximately 26 mm vessel
can be approximately 34 mm. Therefore, in some embodiments, the
diameter of the main graft body 22 can be approximately 8 mm larger
than the diameter of the target vessel. In some embodiments, the
diameter of the main graft body 22 can be between approximately 2
mm and approximately 14 mm, or between approximately 4 mm and
approximately 12 mm, or between approximately 6 mm and
approximately 10 mm larger than the diameter of the target vessel,
or to or from any values within these ranges.
[0114] The oversized diameter of the main graft body 22 can provide
excess or slack graft material in the main graft body 22 such that
the fenestrations 24, 26 can each be moved in an axial or angular
direction to align the fenestrations 24, 26 with the branch vessels
arteries, as will be described in greater detail below.
[0115] As described above, two or more fenestrations can be formed
in the main graft body 22 at any desired location. With reference
to FIG. 2, the two fenestrations 24, 26 can be formed at generally
diametrically opposed locations. However, any number of
fenestrations can be formed in the main graft body 22 at any
desired locations. Additionally, scallops or cutouts can be formed
in the distal end portion or at any suitable location in the main
graft body 22, the scallops or cutouts being configured to prevent
obstruction of other arteries branching off of the main vessel into
which the main graft body 22 is to be deployed. For example, in
some embodiments, an additional fenestration 32 can be formed in a
distal portion of the main graft body 22. The fenestration 32 can
be foamed so as to align with a patient's SMA
[0116] FIG. 3 is a cross-sectional view of the embodiment of the
endoluminal prosthesis 20 deployed in the patient's anatomy, taken
through line 3-3 in FIG. 1, before the fenestrations 24, 26 have
been aligned with the respective branch vessels, for example renal
arteries 12, 14. With reference to FIG. 3, the main graft body 22
(which can be oversized) has been deployed in the target vessel. In
some embodiments, after the main graft body 22 has been deployed in
the target vessel, because the main graft body 22 can have a larger
diameter than the vessel diameter, folds, wrinkles, or other
undulations (collectively referred to as folds) 34 can form in the
main graft body 22 about the circumference of the main graft body
22. The folds 34 can form in the main graft body 22 as a result of
the fact that there can be excess or slack material in the main
graft body 22 after the main graft body 22 has been deployed in the
target vessel.
[0117] In some embodiments, at least a portion of the main graft
body 22 can have undulations, folds, bends, corrugations, or other
similar features in the axial direction therein when the main graft
body 22 is in a relaxed state (i.e., before the graft has been
deployed). In some embodiments, a middle portion of the graft can
have undulations, folds, bends, corrugations or other similar
features while the distal or upstream portion defines a smooth
contour
[0118] FIG. 4 is a cross-sectional view of the embodiment of the
endoluminal prosthesis 20 deployed in the patient's anatomy, taken
through line 3-3 in FIG. 1, after the fenestrations 24, 26 have
been aligned with the respective branch vessels. With reference to
FIG. 4, the oversized main graft body 22 can be aligned with the
patient's anatomy by moving fenestration 24 to align the
fenestration 24 with the respective branch vessel and by moving the
fenestration 26 to align the fenestration 26 with the other
respective branch vessel. For example, the fenestration 24 can be
drawn closer to the fenestration 26, thereby gathering slack
material or folds 34 in a first portion 22a of the main graft body
22 and partially or fully removing the slack material or folds from
a second portion 22b of the main graft body 22.
[0119] After the main graft body 22 has been positioned within the
patient's anatomy such that the fenestrations 24, 26 have been
aligned with the respective branch vessels, a covered stent, a bare
wire stent, or any other suitable stent or anchoring device can be
deployed within the main graft to secure the graft in the desired
location (not illustrated). In some embodiments, a bare metal stent
deployed within the main graft body 22 can compress the folds 34
that are formed in the main graft body 22, if any, against the wall
of the vessel and secure the main graft body 22 and the
fenestrations 24, 26 in the desired locations.
[0120] Alternatively, a supra renal stent can be deployed at a
distal or upper portion of the main graft body to secure the distal
or upper portion of the main graft body in the desired location
within the patient's vasculature, and one or more axial springs 40
can be anchored to the main graft body to provide axial or column
strength to the main graft body. The springs 40 can have a helical
shape, as illustrated, and can have any suitable size, length,
pitch, or diameter. However, such helical shape is not required. In
some embodiments, the springs 40 can have any suitable shape,
including a straight, flat, round, or non-round shape. The springs
40 can be formed from any suitable biocompatible material, such as
without limitation stainless steel, Nitinol, or suitable metalic or
polymeric materials.
[0121] FIG. 5 is a partial section view of a patient's vasculature
illustrating another embodiment of an endoluminal prosthesis 20'
deployed in the desired position within the patient's vasculature
wherein the main graft body 22' can have a supra renal stent 38
deployed within the upper or distal end portion of the main graft
body 22' and one or more axial springs 40 secured to the main graft
body 22'. The springs 40 can be secured to the main graft body 22'
using any suitable fasteners or method, such as without limitation,
sutures or adhesive.
[0122] In some embodiments, any of the embodiments of the
endoluminal prostheses disclosed herein can be formed such that one
or more portions of the main graft body have an enlarged diameter,
while one or more other portions of the main graft body can have a
reduced diameter as compared to the enlarged diameter. For example,
with reference to FIG. 6, which is a side view of another
embodiment of an endoluminal prosthesis 60, the endoluminal
prosthesis 60 can have a main graft body 62 and fenestrations 64,
66 formed therein. In some embodiments, an additional fenestration
68 can be formed in the main graft body 62 to accommodate blood
flow to the SMA or otherwise. With reference to FIG. 6, a first or
upper portion 62a of the main graft body 62 can have a first
diameter while a second or lower portion 62b can have a second
diameter. In some embodiments, as in the illustrated embodiment,
the first portion 62a can have a smaller diameter than the second
portion 62b of the main graft body 62. Accordingly, to accommodate
adjustability of the fenestrations 64, 66, the fenestrations 64, 66
can be formed in the second or enlarged portion 62b of the main
graft body 62.
[0123] The first portion 62a can have any diameter suitable for the
size of the target vessel. Additionally, the second portion 62b can
have an enlarged diameter within any of the ranges described above
with respect to the main graft body 22. For example, without
limitation, the endoluminal prosthesis 60 can be configured for
deployment in a 26 mm target vessel, wherein the first portion 62a
can have an approximately 28 mm or any other suitable diameter, and
the second portion 62b can have an approximately 34 mm or any other
suitable enlarged diameter so as to allow for the adjustability of
the fenestrations 64, 66. As illustrated in FIG. 6, the diameter of
the main graft body 62 in the second portion 62b can transition
from the diameter of the first portion 62a to the diameter of the
remainder of the second portion 62b.
[0124] FIG. 7 is a side view of another embodiment of an
endoluminal prosthesis 70 having a main graft body 72 and
fenestrations 74, 76 formed therein. In some embodiments, an
additional fenestration or cutout 78 can be formed in the main
graft body 72 to accommodate blood flow to the SMA or otherwise.
With reference to FIG. 7, a first or upper portion 72a of the main
graft body 72 can be tapered from a first to a second diameter,
while a second or lower portion 72b can have a second diameter. In
some embodiments, as in the illustrated embodiment, the first
portion 72a can have a smaller diameter than the second portion 72b
of the main graft body 72. Accordingly, to accommodate
adjustability of the fenestrations 74, 76, the fenestrations 74, 76
can be formed in the second or enlarged portion 72b of the main
graft body 72.
[0125] The first portion 72a can have any suitable first diameter
for the size of the target vessel. Additionally, the second portion
72b can have an enlarged diameter within any of the ranges
described above. For example, without limitation, the endoluminal
prosthesis 70 can be configured for deployment in a 26 mm target
vessel, wherein the first portion 72a can have an approximately 28
mm first diameter that tapers outwardly to an approximately 34 mm
second diameter, and the second portion 72b can have an
approximately 34 mm diameter so as to allow for the adjustability
of the fenestrations 74, 76.
[0126] FIG. 8 is a side view of another embodiment of an
endoluminal prosthesis 80 having a main graft body 82 and
fenestrations 84, 86 formed therein. In some embodiments, an
additional fenestration 88 can be formed in the main graft body 82
to accommodate blood flow to the SMA or otherwise. With reference
to FIG. 8, a first or upper portion 82a of the main graft body 82
can have a first diameter, a second or middle portion 82b can have
a second diameter, and a third or lower portion 82c can have a
third diameter. In some embodiments, as in the illustrated
embodiment, the first portion 82a can have a smaller diameter than
the second portion 82b of the main graft body 82. Additionally, the
third portion 82c can have a smaller diameter than the second
portion 82b of the main graft body 82. In some embodiments, the
third portion 82c can have the same diameter as compared to the
first portion 82a. Accordingly, to accommodate adjustability of the
fenestrations 84, 86, the fenestrations 84, 86 can be formed in the
second or enlarged portion 82b of the main graft body 82. The
second portion 82b can have a generally curved surface, or can
define a generally cylindrical surface that conically or curvedly
tapers to the diameter of the first and third portions 82a,
82c.
[0127] The first portion 82a can have any suitable first diameter
for the size of the target vessel. Additionally, as mentioned, the
second portion 82b can have an enlarged diameter within any of the
ranges described above. For example, without limitation, the
endoluminal prosthesis 80 can be configured for deployment in a 26
mm target vessel, wherein the first portion 82a can have an
approximately 28 mm diameter, the second portion 82b can have an
approximately 34 mm diameter so as to allow for the adjustability
of the fenestrations 84, 86, and the third portion 82c can have an
approximately 28 mm diameter.
[0128] Please note that any of the endoluminal prostheses disclosed
or described herein can be bifurcated or non-bifurcated, and can be
formed from any suitable material, such as but not limited to
ePTFE. Additionally, any of the deployment procedures described
herein or any other suitable deployment procedures currently known
or later developed that are suitable for such endoluminal
prostheses can be used to deploy any of the endoluminal prostheses
described herein. Further, any of the endoluminal prostheses can be
secured to the target vessel wall using covered stents, bare metal
stents, supra renal stents, springs, anchors, or any other suitable
medical device or fasteners. For example, without limitation, with
reference to FIG. 9, which is a side view of another embodiment of
an endoluminal prosthesis 90, the endoluminal prosthesis 90 can be
a bifurcated prosthesis. As illustrated therein, the main graft
body 92 can have three portions 92a, 92b, 92c of varying
diameters.
[0129] Further, in any of the graft embodiments disclosed herein,
at least a portion of the graft material adjacent to the one or
more fenestrations or openings, such as the graft material in the
enlarged section 92b, can be free to translate in a circumferential
or axial direction relative to the stent that the graft is
supported by. For example, without limitation, particular portions
of the graft material, such as the end portions of the graft
material, can be sutured or otherwise fastened to the stent, while
a mid or enlarged portion of the graft having one or more
fenestrations therethrough can be unattached to the stent so that
such portion can be free to translate relative to the stent. This
configuration can improve the adjustability of the graft material
and, hence, the fenestrations, relative to the stent, permitting
the fenestrations to be adjusted to align with the ostium of the
patient's branch vessels.
[0130] Additionally, as mentioned above, any of the embodiments of
the endoluminal prostheses disclosed herein (which is meant
throughout this specification to include the embodiments
incorporated herein by reference) can be formed with a branch graft
adjacent to one or more of the openings or fenestrations formed in
the main graft body. For example, with reference to FIG. 10, which
is a side view of another embodiment of an endoluminal prosthesis
100, the endoluminal prosthesis 100 can have a main graft body 102
and branch grafts 104, 106 supported by the main graft body 102. In
some embodiments, an additional fenestration 108 can be formed in
the main graft body 102 to accommodate blood flow to the SMA or
otherwise. Alternatively, an additional branch graft (not
illustrated) can be supported by the main graft body 102 to
accommodate the blood flow to the SMA
[0131] With reference to FIG. 10, a first or upper portion 102a of
the main graft body 102 can have a first diameter, a second or
middle portion 102b can have a second diameter, and a third or
lower portion 102c can have a third diameter. The main graft body
102 can have any suitable shape, including any of the shapes
disclosed elsewhere herein. In some embodiments, as in the
illustrated embodiment, the first portion 102a can have a smaller
diameter than the second portion 102b of the main graft body 102.
Additionally, the third portion 102c can have a smaller diameter
than the second portion 102b of the main graft body 102. In some
embodiments, the third portion 102c can have the same diameter as
compared to the first portion 102a. Accordingly, to accommodate
adjustability of the branch grafts 104, 106, the branch grafts 104,
106 can be supported by the second or enlarged portion 102b of the
main graft body 102.
[0132] The first portion 102a can have any suitable first diameter
for the size of the target vessel. Additionally, as mentioned, the
second portion 102b can have an enlarged diameter within any of the
ranges described above. For example, without limitation, the
endoluminal prosthesis 100 can be configured for deployment in a 26
mm target vessel, wherein the first portion 102a can have an
approximately 28 mm diameter, the second portion 102b can have an
approximately 34 mm diameter so as to allow for the adjustability
of the fenestrations 104, 106, and the third portion 102c can have
an approximately 28 mm diameter.
[0133] In some embodiments, the branch grafts 104, 106 can be
integrally formed with the main graft body 12. Alternatively, the
branch graft portions 104, 106 can be formed separately and later
attached, adhered, sutured, or otherwise fastened or supported by
the main graft body 102. In some embodiments, the main graft body
102 can have fenestrations or openings in place of the branch
grafts 104, 106.
[0134] Additionally, as mentioned above, any of the embodiments of
the endoluminal prostheses disclosed herein can be formed with a
branch graft adjacent to one or more of the openings or
fenestrations formed in the main graft body. For example, with
reference to FIG. 10, which is a side view of another embodiment of
an endoluminal prosthesis 100, the endoluminal prosthesis 100 In
some embodiments, an additional fenestration 108 can be formed in
the main graft body 102 to accommodate blood flow to the SMA or
otherwise. Alternatively, an additional branch graft (not
illustrated) can be supported by the main graft body 102 to
accommodate the blood flow to the SMA
[0135] With reference to FIG. 10, a first or upper portion 102a of
the main graft body 102 can have a first diameter, a second or
middle portion 102b can have a second diameter, and a third or
lower portion 102c can have a third diameter. The main graft body
102 can have any suitable shape, including any of the shapes
disclosed elsewhere herein. In some embodiments, as in the
illustrated embodiment, the first portion 102a can have a smaller
diameter than the second portion 102b of the main graft body 102.
Additionally, the third portion 102c can have a smaller diameter
than the second portion 102b of the main graft body 102. In some
embodiments, the third portion 102c can have the same diameter as
compared to the first portion 102a. Accordingly, to accommodate
adjustability of the branch grafts 104, 106, the branch grafts 104,
106 can be supported by the second or enlarged portion 102b of the
main graft body 102.
[0136] The first portion 102a can have any suitable first diameter
for the size of the target vessel. Additionally, as mentioned, the
second portion 102b can have an enlarged diameter within any of the
ranges described above. For example, without limitation, the
endoluminal prosthesis 100 can be configured for deployment in a 26
mm target vessel, wherein the first portion 102a can have an
approximately 28 mm diameter, the second portion 102b can have an
approximately 34 mm diameter so as to allow for the adjustability
of the fenestrations 104, 106, and the third portion 102c can have
an approximately 28 mm diameter.
[0137] In some embodiments, the branch grafts 104, 106 can be
integrally formed with the main graft body 12. Alternatively, the
branch graft portions 104, 106 can be formed separately and later
attached, adhered, sutured, or otherwise fastened or supported by
the main graft body 102.
[0138] FIG. 11 is a side view of another embodiment of an
endoluminal prosthesis 110. As with any of the embodiments of the
endoluminal prostheses disclosed herein, any of the features of the
endoluminal prosthesis 110 can be combined with any of the features
of any other embodiment or combination of embodiments of the
endoluminal prostheses disclosed herein. Additionally, endoluminal
prosthesis 110 can have any of the features, components, or other
details of any of the other embodiments of the endoluminal
prostheses disclosed (directly or by incorporation by reference)
herein. As illustrated in FIG. 11, the endoluminal prosthesis 110
can have a main graft body 112, fenestrations 114, 116 formed in
the main graft body 112, and an opening or cutout 118 formed in the
distal end portion of the main graft body 112 to accommodate blood
flow to the SMA or otherwise. In some embodiments, branch grafts
can be positioned within the fenestrations 114, 116, or can be
sewn, adhered, or otherwise attached to the main graft body 112
adjacent to the fenestrations 114, 116.
[0139] In some embodiments, the main graft body 112 can have three
portions 112a, 112b, 112c of varying diameters. However, in some
embodiments, the diameter of the three portions 112a, 112b, 112c of
the main graft body 112 can be approximately the same. As
illustrated in FIG. 11, the first portion 112a can have any
diameter suitable for the size of the target vessel. Additionally,
the second portion 112b can have an enlarged diameter within any of
the ranges described above with respect to the main graft body 22.
For example, without limitation, the endoluminal prosthesis 110 can
be configured for deployment in a 26 mm target vessel, wherein the
first portion 112a can have an approximately 28 mm or any other
suitable diameter, and the second portion 112b can have an
approximately 34 mm or any other suitable enlarged diameter so as
to allow for the adjustability of the fenestrations 114, 116. The
diameter of the third portion 112c can be similar to the diameter
of the first portion 112a, or can be any suitable diameter.
[0140] Additionally, in some embodiments, the main graft body 112
be sized and configured so as to have excess length or material 120
in the graft material. For example, as illustrated in FIG. 11, the
main graft body 112 can be sized and configured so as to have
excess material 120 below the enlarged second portion 112b. In some
embodiments, the main graft body 112 can be configured so that the
excess material 120 is positioned above the enlarged second portion
112b, or so that excess material 120 is positioned both above and
below the enlarged second portion 112b to allow for greater axial
and/or radial adjustability of the fenestrations 114, 116. The
excess material positioned above and/or below the enlarged portion
or, if no enlarged portion, above and/or below the fenestrated
portion, can permit a greater amount of adjustability of the
fenestrations or branch grafts. Any of the embodiments of grafts
disclosed herein can have excess material positioned above and/or
below the enlarged or fenestrated portion of the graft, or at any
suitable position on the graft to increase the adjustability of the
fenestrations or branch grafts.
[0141] In some embodiments, the excess material 120 can be
approximately 20% of the unstretched length of the main graft body
112. In some embodiments, the excess material 120 can be from
approximately 10% or less to approximately 30% or more of the
unstretched length of the main graft body 112. For example, in some
embodiments, the total excess length of the graft can be
approximately 2 cm. In some embodiments, the total excess length of
the graft can be between approximately 1 cm and approximately 3 cm
such that a main graft body 112 having an unstretched length of
approximately 10 cm can have from approximately 11 cm or less to
approximately 13 cm or more of graft material positioned
thereon.
[0142] In some embodiments, the endoluminal prosthesis 110 can have
a supra visceral stent or stent segment 122 deployed within the
first or distal end portion 112a of the main graft body 112, a
stent segment 124 deployed within the third or proximal end portion
112c of the main graft body 112, and one or more axial springs 126
extending between the supra renal stent segment 122 and the stent
segment 124. In some embodiments, the springs 126 can be
substantially rigid so as to axially position the stent segment 122
at a fixed position relative to the stent segment 124. The springs
126 can be attached to the stent segments 124, 126 at connection
points 128.
[0143] The endoluminal prosthesis 110 can be configured such that
the main graft body 112 is secured to the stent segments 122, 124
only at the end portions of the main graft body 112. In some
embodiments, the endoluminal prosthesis 110 can be configured such
that the main graft body 112 is secured to the stent segments 122,
124 at the end portions of the main graft body 112 and also at one
or more intermediate positions, such as at positions adjacent to
one or more of the connection points 128.
[0144] In some embodiments (not illustrated), the endoluminal
prosthesis 110 can be configured to be a bifurcated prosthesis,
having one or more branch portions extending below the stent 124.
In such embodiments, the main graft body 112 can extend below the
stent 124 so as to comprise the branch graft portions.
Alternatively, bifurcation branch graft portions can be formed
separately and stitched or otherwise attached to the main graft
body 112. Further, in some embodiments, bifurcation branch stents
can be pre-positioned within or otherwise deployed within the
branch grafts.
[0145] FIG. 12 is a side view of another embodiment of an
endoluminal prosthesis 140. FIG. 12A is an enlarged side view of
the embodiment of the endoluminal prosthesis 140 defined by curve
12A-12A in FIG. 12. As with any of the embodiments of the
endoluminal prostheses disclosed (directly or by incorporation by
reference) herein, any of the features of the endoluminal
prosthesis 140 can be combined with any of the features of any
other embodiment or combination of embodiments of the endoluminal
prostheses disclosed (directly or by incorporation by reference)
herein. As such, endoluminal prosthesis 140 can have any of the
features, components, or other details of any of the other
embodiments of the endoluminal prostheses disclosed herein. As
illustrated in FIG. 12, the endoluminal prosthesis 140 can have a
main graft body 142, fenestrations 144, 146 formed in the main
graft body 142, and an opening or cutout 148 formed in the distal
end portion of the main graft body 142 to accommodate blood flow to
the SMA or otherwise. In some embodiments, branch grafts can be
positioned within the fenestrations 144, 146, or can be sewn,
adhered, or otherwise attached to the main graft body 112 adjacent
to the fenestrations 144, 146.
[0146] In some embodiments, the diameter of the fenestrations 144,
146 or any other fenestrations disclosed herein can be from
approximately 1 mm to approximately 10 mm or more, or from
approximately 3 mm to approximately 8 mm, or from approximately 4
mm to approximately 6 mm. The fenestrations 144, 146 can be
positioned at any desired or suitable axial or radial position in
the main graft body 142 based on a patient's anatomy. In some
embodiments, as illustrated in FIG. 12, the fenestrations 144, 146
can be circumscribed with a supportive graft material 150 (also
referred to herein as a fenestration border) to increase the
strength of the graft material adjacent to the fenestrations 144,
146. In some embodiments, the fenestration border 150 can increase
the strength of the graft material adjacent to the fenestrations
144, 146 so that the fenestrations 144, 146 can withstand expansion
pressures of up to approximately 15 atm or more.
[0147] In some embodiments, the fenestration border 150 can be a
generally cylindrically shaped tube of graft material such as PTFE,
ePTFE, or any other suitable material that is formed around the
fenestration. For example, with reference to FIGS. 12 and 12A, the
tube of graft material can be slit longitudinally along the length
thereof and positioned over the edge of the fenestrations 144, 146.
The fenestration border 150 can be bonded, sutured, or otherwise
attached to or supported by the main graft body 142 adjacent to the
fenestrations 144, 146. In some embodiments, the fenestration
border 150 can be a ring of polyurethane or urethane that can be
bonded, sutured, or otherwise attached to or supported by the main
graft body 142 adjacent to the fenestrations 144, 146. The
polyurethane or urethane can allow for radial expansion of the
fenestration by a balloon expander or other suitable expander. In
some embodiments, the polyurethane or urethane rings (or rings made
from any other suitable material) can be positioned between two or
more sheets or layers of graft material (such as, but not limited
to, ePTFE) having the polyurethane or urethane bonded thereto. The
sheets or layers can be positioned relative to one another with the
polyurethane or urethane surfaces facing each other so that the
polyurethane or urethane is sandwiched between the sheets or layers
of the graft material.
[0148] In some embodiments, as in the illustrated embodiment, a
radiopaque material (that can be non-rigid or spring-like) can be
embedded in or supported within the fenestration border 150. The
radiopaque marker can be formed from platinum iridium, which can be
in the form of a spring, or any other suitable metallic material
known to the industry.
[0149] FIG. 13 is a side view of another embodiment of an
endoluminal prosthesis 170. FIG. 14 is a top view of the embodiment
of the endoluminal prosthesis 170 shown in FIG. 13. The embodiment
of the endoluminal prosthesis 170 illustrated in FIGS. 13 and 14
can have a main graft body 172, a first fenestration 174, and a
second fenestration 176. In some embodiments, as in the illustrated
embodiment, the main graft body 172 can be bifurcated, having a
first bifurcated branch 178 and a second bifurcated branch 180 for
placement in the ipsilateral and contralateral iliac arteries and a
lumen 182 through the main graft body 172 in communication with the
openings in the first and second bifurcated branches 178, 180.
Additionally, in some embodiments, the endoluminal prosthesis 170
can have any of the components, features, dimensions, materials, or
other details of any of the other embodiments of endoluminal
prostheses disclosed or incorporated by reference herein, or any
other suitable features of endoluminal prostheses known in the
field.
[0150] The endoluminal prosthesis 170 can be formed from any
suitable material, such as, but not limited to, ePTFE. In some
embodiments, the endoluminal prosthesis 170 can be formed from an
expandable material. The endoluminal prosthesis 170 can be formed
such that at least a portion of the main graft body 172 can be
significantly larger than the target vessel into which the main
graft body 172 is to be deployed. With reference to FIG. 13, the
endoluminal prosthesis 170 can be bifurcated and can be deployed so
as to span across an aneurysm in the abdominal aortic. In some
embodiments, at least a portion of the main graft body 172 can have
a diameter that can be approximately 30% larger than the diameter
of the target vessel. In some embodiments, at least a portion of
the main graft body 172 can have a diameter that can be from
approximately 20% or less to approximately 50% or more, or from
approximately 25% to approximately 40% larger than the target
vessel, or to or from any values within these ranges.
[0151] As one non-limiting example, the main graft body 172
configured for placement in an approximately 28 mm vessel can have
at least a portion thereof that has a diameter of approximately 34
mm. Therefore, in some embodiments, the diameter of at least a
portion of the main graft body 172 can be approximately 8 mm larger
than the diameter of the target vessel. In some embodiments, the
diameter of at least a portion of the main graft body 172 can be
between approximately 2 mm and approximately 14 mm, or between
approximately 4 mm and approximately 12 mm, or between
approximately 6 mm and approximately 10 mm larger than the diameter
of the target vessel, or to or from any values within these
ranges.
[0152] For example, with reference to FIG. 13, the main graft body
172 can have a first portion 172a, a second or middle portion 172b,
and a third or lower portion 172c. In some embodiments, the first
portion 172a can have a generally cylindrical shape defined by a
first diameter. In some embodiments, the second portion 172b can
have a generally spherical shape defined by a second, enlarged
diameter. The third portion 172c can have a generally cylindrical
shape defined by a third diameter. The third diameter can be
approximately the same as the first diameter, or can be larger or
smaller than the first diameter. In some embodiments, the second
portion 172b can have approximately the same cross-sectional
diameter as compared to the first portion 172a, the second portion
172b having corrugations 184 formed therein, as described below, to
allow for the adjustability of the fenestrations 174, 176 or branch
grafts (not illustrated).
[0153] As discussed above, the oversized diameter of the main graft
body 172 can provide excess or slack graft material in the main
graft body 172 such that the fenestrations 174, 176 can each be
moved in an axial or angular direction to align the fenestrations
174, 176 with the branch vessels arteries. In some embodiments,
branch grafts (not illustrated) can be integrally formed with the
main graft body 172, or can be formed separately and later
attached, adhered, sutured, or otherwise fastened or supported by
the main graft body 172.
[0154] As described above, two or more fenestrations 174, 176 can
be formed in the main graft body 172 at any desired location. With
reference to FIG. 13, the two fenestrations 174, 176 can be formed
at generally diametrically opposed locations. However, any number
of fenestrations can be formed in the main graft body 172 at any
desired locations. Additionally, scallops or cutouts can be formed
in the distal end portion or at any suitable location in the main
graft body 172, the scallops or cutouts being configured to prevent
obstruction of other arteries branching off of the main vessel into
which the main graft body 172 is to be deployed. For example, in
some embodiments, an additional fenestration can be formed in a
distal portion of the main graft body 172 so as to align with a
patient's SMA.
[0155] In some embodiments, as in the illustrated embodiment, the
fenestrations 174, 176 can be formed in the second portion 172b of
the main graft body 172. In some embodiments, the surface of the
second portion 172b of the main graft body 172 can have waves,
undulations, folds, corrugations, or other similar features 184
(collectively referred to as corrugations) pre-formed therein. The
corrugations 184 can be formed in an axial direction, as
illustrated in FIGS. 13 and 14, or can be formed in a lateral
direction or at any other suitable angular orientation.
Additionally, the corrugations 184 can have a linear shape, as
illustrated, or can have a curved or any other suitable shape, such
as is illustrated in FIGS. 15 and 16.
[0156] FIG. 15 is a side view of another embodiment of an
endoluminal prosthesis 190, and FIG. 16 is an enlargement of a
portion of the embodiment of an endoluminal prosthesis 190 shown in
FIG. 15, defined by curve 16-16, illustrating the adjustability of
a branch graft. With reference to FIGS. 15 and 16, the embodiment
of the endoluminal prosthesis 190 illustrated therein can have a
main graft body 192, a first branch graft 194, and a second branch
graft 196. In some embodiments, as in the illustrated embodiment,
the main graft body 192 can be bifurcated, having a first
bifurcated branch 198 and a second bifurcated branch 200 for
placement in the ipsilateral and contralateral iliac arteries and a
lumen 202 through the main graft body 192 in communication with the
openings in the first and second bifurcated branches 198, 180.
[0157] Additionally, in some embodiments, the endoluminal
prosthesis 190 can have any of the components, features,
dimensions, materials, or other details of any of the other
embodiments of endoluminal prostheses disclosed or incorporated by
reference herein, or any other suitable features of endoluminal
prostheses known in the field. For example, without limitation, in
some embodiments, the main graft body 192 can be formed without the
branch grafts 194, 196 so that fenestrations are to be aligned with
the branch vessels. Further, any suitable number of branch grafts
or fenestrations can be formed on the main graft body 192.
[0158] With reference to FIGS. 15 and 16, the corrugations 204
formed in the main graft body 192 can be curved. In some
embodiments, the corrugations 204 can be generally curved in shape
and can be formed about the axial centerline of each of the branch
grafts 194, 196. With reference to FIG. 15, line L1 represents the
axial centerline of each of the branch grafts 194, 196 when the
branch grafts 194, 196 are in a relaxed state. In some embodiments,
the corrugations 204 can define a generally circular shape. As
described with respect to endoluminal prosthesis 170 described
above, the corrugations 204 can be configured to allow the branch
grafts 194, 196 to move in an axial or angular direction to align
the branch grafts 194, 196 with the branch vessels arteries.
[0159] As mentioned, FIG. 16 is an enlargement of a portion of the
endoluminal prosthesis 190 shown in FIG. 15, illustrating the
adjustability of a branch graft 196. For example, the branch graft
196 can be adjusted from the position defined by line L1 (which
represents the axial centerline of the branch graft 196 in the
relaxed state) to the position defined by line L2 (which represents
the axial centerline of the branch graft 196 in the adjusted
state). As the branch graft is adjusted from the positioned defined
by line L1 to the position defined by line L2, the portions of the
corrugations 204a above the line L2 gather or become closer
together, while the portions of the corrugations 204b below the
line L2 stretch or move further apart from one another, thus
allowing the branch graft 196 to be adjusted upwardly without
deforming or stretching other portions of the main graft body 192.
Lines L1 and L2 are meant to describe the adjustment of the branch
grafts 194, 196 in any suitable axial or angular direction and are
not meant to be limited by the example or examples provided herein.
Further, lines L1 and L2 need not be parallel lines, since angular
orientation of the branch grafts 194, 196 relative to the main
graft body 192 can be adjustable also.
[0160] In the illustrated embodiment, the branch grafts 194, 196
can be approximately aligned so that the axial centerline of the
branch graft 194 is approximately collinear with the axial
centerline of the branch graft 196. In some embodiments, the branch
grafts 194, 196 can be positioned on the main graft body 192 so
that the axial centerline of the branch graft 194 is not aligned or
collinear with the axial centerline of the branch graft 196.
[0161] In some of the embodiments disclosed herein, one or more
stents can be pre-positioned within the branch grafts before the
endoluminal prosthesis has been deployed in the target location.
For example, in some embodiments, the one or more stents can be
balloon expandable, self-expandable, or other suitable stents that
can be positioned within the branch grafts before the endoluminal
prosthesis is loaded into a delivery catheter. For example, with
reference to FIG. 17, which is a side view of another embodiment of
an endoluminal prosthesis 300, the endoluminal prosthesis 300 can
have a main graft body 302 and branch grafts 304, 306 supported by
the main graft body 302. In some embodiments, an additional
fenestration can be formed in the main graft body 302 to
accommodate blood flow to the SMA or otherwise. Alternatively, a
branch graft (not illustrated) can be supported by the main graft
body 302 to accommodate the blood flow to the SMA
[0162] The endoluminal prosthesis 300 illustrated in FIG. 17 can
have any of the same features as compared to the embodiment of the
endoluminal prosthesis 100 illustrated in FIG. 10 and described
above or any of the embodiments of the endoluminal prostheses
disclosed (directly or by incorporation by reference) herein. As
with the endoluminal prosthesis 100 illustrated in FIG. 10 above,
to accommodate positional adjustability of the branch grafts 304,
306, the branch grafts 304, 306 can be supported by the second or
enlarged portion 302b of the main graft body 302.
[0163] In some embodiments, the branch grafts 304, 306 can be
integrally formed with the main graft body 302. Alternatively, the
branch graft portions 304, 306 can be formed separately and later
attached, adhered, sutured, or otherwise fastened or supported by
the main graft body 302. Additionally, before the endoluminal
prostheses 300 is loaded into a delivery catheter, first and second
guidewires 310, 312 can be advanced through the branch grafts 304,
306, respectively. In some embodiments, the guidewires 310, 312 can
be hollow so that they can be passed or advanced over guidewires
that are pre-wired in the patient's vasculature to guide the
endoluminal prostheses 300 to the target location. Advancing the
guidewires 310, 312 over the pre-wired guidewires can also
facilitate the alignment of each of the branch grafts 304, 306 with
each of the branch vessels in the patient's vasculature.
[0164] In some embodiments, the guidewires 310, 312 can be made
from a plastic extrusion or metal braids. For example, in some
embodiments, the hollow guidewires 310, 312 can be made from
braided Nitinol wire. In some embodiments, the outer diameter of
the guidewires 310, 312 can be approximately 0.035 in and the lumen
of the guidewire can be approximately 0.016 in to accommodate a
second 0.014 in guidewire. In some embodiments, the guidewires 310,
312 can be configured to pass over a 0.018 in or any other suitable
guidewire. As mentioned above, in some embodiments, the guidewires
310, 312 can support balloons on the distal ends of the guidewires
310, 312. The balloons can be inflated in the branch vessel to
deploy expandable stents within the branch grafts 304, 306.
[0165] Additionally, as illustrated in FIG. 17, stents 314, 316 can
be positioned within each of the branch grafts 304, 306,
respectively, before the endoluminal prosthesis 300 is loaded into
the delivery catheter. In some embodiments, each of the stents 314,
316 can be a bare metal stent or a covered stent (i.e., covered
with a tubular shaped graft material). Additionally, in some
embodiments, the stents 314, 316 can be self expanding or can be
balloon expandable. In the illustrated embodiment, each of the
stents 314, 316 can be supported by an expansion balloon 318, 320,
respectively, positioned within each of the branch grafts 304, 306.
Accordingly, each of the guidewires 310, 312 can be configured to
allow for the inflation and expansion of the expansion balloons
318, 320. For example, the guidewires 310, 312 can have a first
lumen that can be advanced over a pre-wired guidewire and a second
inflation lumen configured to communicate a positive pressure to
each of the expansion balloons 318, 320.
[0166] In some embodiments, the endoluminal prostheses 300 can be
loaded into a delivery catheter so that each of the guidewires 310,
312 protrudes out from the inside of an outer sleeve of the
delivery catheter so that each of the guidewires 310, 312 can be
advanced over the pre-wired guidewires positioned within the
patient's vasculature. Thus, during deployment, in some
embodiments, each of the stents 314, 316 can be expanded and hence
deployed within each of the branch grafts 304, 306 after each of
the branch grafts 304, 306 has been aligned and positioned within
the respective branch vessels. In some embodiments, each of the
stents 314, 316 can be expanded and hence deployed within each of
the branch grafts 304, 306 before the main graft body 302 has been
secured in the main target vessel.
[0167] In some embodiments, the stents 314, 316 and the expansion
balloons 318, 320 can be supported within the branch grafts 304,
306, respectively, so that the stents 314, 316 and the expansion
balloons 318, 320 are axially secured to each of the branch grafts
304, 306. In this arrangement, advancing the guidewires 310, 312
and, accordingly, the stents 314, 316 and the expansion balloons
318, 320, into the respective branch vessels after the endoluminal
prosthesis 300 has been at least partially released from the
deployment catheter, can allow the branch grafts 304, 306 to be
aligned with and advanced into the target branch vessels.
[0168] Additionally, in some embodiments, covered or uncovered
stents can be pre-positioned in the main graft body of a
fenestrated endoluminal prosthesis so as to be partially advanced
through each of the fenestrations before the endoluminal prosthesis
is loaded into the delivery catheter. The stents can be secured to
or otherwise configured to engage each of the fenestrations such
that, as the stents are advanced along the pre-wired guidewires
into the respective branch vessels, the fenestrations can be
aligned with the respective branch vessels. In some embodiments,
the stents can have flanged portions or be partially expanded so as
to engage the fenestrations such that advancing the stents into the
respective branch vessels can align the fenestrations with the
respective branch vessels. Additionally, in some embodiments, the
guidewires themselves can be configured to engage each of the
fenestrations such that, as the deployment guidewires are advanced
along the pre-wired guidewires into the respective branch vessels,
the fenestrations can be aligned with the respective branch vessels
without the use of stents for alignment.
[0169] However, the pre-positioning of the stents 314, 316 and the
balloons 318, 320 in the endoluminal prostheses 300 described above
is not required. In some embodiments, one or more stents can be
advanced through the patient's vasculature and into the branch
grafts 304, 306 after the endoluminal prostheses 300 has been
positioned within the target vessel in the patient's vasculature.
For example, one or more stents can be advanced through the
patient's vasculature into the branch grafts 304, 306 after the
branch grafts 304, 306 have been positioned within the target
branch vessels and after the main graft body 302 has been secured
within the main target vessel.
[0170] Additionally, any of the features, components, or details of
any of the graft, stents, or other apparatuses disclosed in U.S.
patent application Ser. No. 12/496,446, filed on Jul. 1, 2009,
entitled CATHETER SYSTEM AND METHODS OF USING SAME, U.S. patent
application Ser. No. 12/390,346, filed on Feb. 20, 2009, entitled
DESIGN AND METHOD OF PLACEMENT OF A GRAFT OR GRAFT SYSTEM, and U.S.
patent application Ser. No. 12/101,863, filed on Apr. 11, 2008,
entitled BIFURCATED GRAFT DEPLOYMENT SYSTEMS AND METHODS can be
used, with or without modification, in place of or in combination
with any of the features or details of any of the grafts, stents,
prostheses, or other components or apparatuses disclosed herein.
Similarly, any of the features, components, or details of the
delivery apparatuses and deployment methods disclosed in U.S.
patent application Ser. Nos. 12/496,446, 12/390,346, and
12/101,863, can be used, with or without modification, to deploy
any of grafts, stents, or other apparatuses disclosed herein, or in
combination with any of the components or features of the
deployment systems disclosed herein. The complete disclosures of
U.S. patent application Ser. Nos. 12/496,446, 12/390,346, and
12/101,863 are hereby incorporated by reference as if set forth
fully herein.
[0171] FIG. 18 is a side view of the endoluminal prosthesis 300
with guidewires 310, 312 advanced through each of the branch grafts
304, 306, showing the endoluminal prostheses 300 being loaded
within a delivery catheter 330. The outer sheath 332 illustrated in
FIG. 18 is sectioned for clarity. With reference to FIG. 18, the
collapsed endoluminal prosthesis 300 can be supported within the
outer sheath 332 of the delivery catheter 330 in the space between
the catheter shaft 334 and the catheter tip 336. In some
embodiments, the hollow guidewires 310, 312 can slide through
openings or lumens in the catheter shaft 86. Alternatively, in some
embodiments, the hollow guidewires 310, 312 can be fixed to the
catheter shaft 334.
[0172] FIG. 19 is a side view of the endoluminal prostheses 300
with guidewires 310, 312 advanced through each of the branch grafts
304, 306, showing the endoluminal prostheses 300 fully loaded
within a delivery catheter 330 and being advanced along guidewires
pre-wired in the patient's vasculature. The outer sheath 332
illustrated in FIG. 19 is sectioned for clarity. With reference to
FIG. 19, as discussed above, the hollow guidewires 310, 312 can be
advanced through the branch grafts 304, 306, respectively, of the
endoluminal prosthesis 300. The endoluminal prosthesis 300 can then
be compressed and loaded within the delivery catheter 330, as is
illustrated in FIG. 19. For example, in this configuration, the
endoluminal prosthesis 300 can be retained in the delivery catheter
330 by the outer sheath 332. Retraction of the outer sheath 332 can
deploy the endoluminal prosthesis 300. With the outer sheath 332
retracted, the endoluminal prosthesis 300 can expand either by
self-expansion, balloon expansion, or by any other suitable method
or mechanism.
[0173] The hollow guidewires 310, 312 can pass through the outer
sheath 332 from the proximal end of the delivery catheter 330
(i.e., the end of the delivery catheter 330 located outside of the
patient) to the distal end of the delivery catheter 330. Each of
the hollow guidewires 310, 312 can be configured to receive or
allow the insertion of a 0.014 in guidewire, a 0.018 in guidewire,
a 0.035 in guidewire, or any diameter guidewire therethrough deemed
suitable for the design. In this configuration, the hollow
guidewires 310, 312 can pass over guidewires 340, 342 that can be
pre-wired in the target vessels.
[0174] As can be seen in FIGS. 18 and 19, in some embodiments, the
catheter 330 can have at least three lumens through at least a
portion of the catheter 330. Each of the three lumens can be
configured to receive a guidewire. Having three lumens through at
least a portion of the catheter 330 can prevent twisting of the
guidewires so as to ensure proper deployment of the endoluminal
prostheses 300 or any other endoluminal prostheses disclosed
(directly or by incorporation by reference) herein. The catheter
330 can be configured to receive the pre-wired guidewire 344
through a lumen formed in the approximate center of the catheter.
The lumen can pass through the catheter tip 336 and the catheter
shaft 334.
[0175] The guidewires 340, 342 can each be pre-wired through the
patient's vasculature to pass into each of the target branch
vessels branching from the target main vessel. The guidewire 344
can be passed through the target main vessel. As described above,
once the endoluminal prosthesis 300 has been advanced to the target
location along the guidewires 340, 342, 344 within the patient's
vasculature, retracting the outer sheath 332 of the catheter 330
and can cause the endoluminal prosthesis 300 to be deployed at the
target location such that each of the branch grafts 304, 306 can be
advanced into each of the branch vessels. After the branch grafts
300, 306 are positioned within the target branch vessels, each of
the stents 304, 306 can be expanded in the branch vessels to secure
the branch grafts 304, 306 in the branch vessels. A stent or other
suitable device can be deployed within the main graft body 302 to
secure the main graft body 302 within the main vessel.
[0176] In some embodiments, one or more of the pre-wired guidewires
340, 342 described above can be configured to be insertable into a
branch vessel and to be biased such that an end portion of the
guidewire 340, 342 remains in the branch vessel. During
manipulation of the guidewires and/or deployment catheter, it
sometimes becomes difficult to maintain the position of the distal
portion of the guidewires in the branch vessels. Biasing the end
portion of the guidewire 340, 342 to remain in the branch vessel
can thus improve any of the deployment procedures described herein.
Additional details regarding such guidewires is set forth
below.
[0177] FIG. 20 is a side view of another embodiment of a delivery
catheter 400 that can be used to deploy at least some of the
embodiments of the endoluminal prostheses disclosed herein, showing
an embodiment of an endoluminal prosthesis 402 being loaded within
a delivery catheter 400. FIG. 21 is an enlarged partial section
view of a portion of the embodiment of a delivery catheter 400
illustrated in FIG. 20, showing the endoluminal prostheses 402
loaded within a delivery catheter 400. As illustrated in FIGS. 20
and 21, the endoluminal prosthesis 402 can be similar to the
endoluminal prosthesis 80 described above, can be a bifurcated
endoluminal prosthesis such as endoluminal prosthesis 90 described
above, or can have any of the features, components, or other
details of any of the other endoluminal prostheses disclosed
herein, directly or by incorporation by reference. As with the
endoluminal prostheses described herein, the main graft body 404
can be configured to accommodate positional adjustability of the
fenestrations 406, 408. For example, without limitation,
fenestrations 406, 408 can be formed within an enlarged portion of
the main graft body 404.
[0178] With reference to FIGS. 20 and 21, the endoluminal
prosthesis 302 can have a main graft body 404 having fenestrations
406, 408 formed therein, and one or more stent segments 410, 412
deployed within the main graft body 404. The stents 410, 412 can be
bare metal, covered, self-expandable, balloon expandable, or any
other suitable stents either disclosed (directly or by
incorporation by reference) herein or otherwise known in the art or
later developed. As illustrated in FIGS. 20 and 21, first and
second guidewire sheaths 420, 422 can be advanced through the
fenestrations 406, 408, respectively, before the endoluminal
prosthesis 402 is loaded into a delivery catheter 400 or otherwise
such that the first and second guidewire sheaths 420, 422 are
advanced through the fenestrations 406, 408, respectively, when the
endoluminal prostheses 402 is in the loaded state in the delivery
catheter 400.
[0179] In some embodiments, the guidewire sheaths 420, 422 can be
hollow so that they can be passed or advanced over pre-positioned
guidewires that are pre-wired in the patient's vasculature to guide
the endoluminal prostheses 402 to the target location. Advancing
the guidewire sheaths 420, 422 over the pre-wired guidewires can
also facilitate the alignment of each of the fenestrations 406, 408
with each of the branch vessels in the patient's vasculature.
[0180] In some embodiments, each of the guidewire sheaths 420, 422
can be made from the same material and have the same features,
sizes, or other details of any other guidewire disclosed herein,
including without limitation guidewires 310, 312 described above.
Additionally, as with guidewires 310, 312, in some embodiments, the
guidewire sheaths 420, 422 can support balloons on the distal ends
of the guidewire sheaths 420, 422. The balloons can be inflated in
the branch vessel to deploy expandable stents within or adjacent to
the fenestrations 406, 408. In some embodiments (not illustrated),
flared, flareable, bare metal, covered, self-expandable, balloon
expandable, or any other suitable stents disclosed (directly or by
incorporation by reference) herein, known in the field, or later
developed can be positioned within each of the fenestrations 406,
408, respectively, before the endoluminal prosthesis 402 is loaded
into the delivery catheter 400. The stents can be deployed
following any suitable procedure, including without limitation the
procedure described above with respect to the stents 314, 316.
[0181] In this configuration, the branch stents (not illustrated)
can be secured to or otherwise configured to engage each of the
fenestrations 406, 408 such that, as the stents are advanced along
the pre-wired guidewires into the respective branch vessels, the
fenestrations 406, 408 can be aligned with the respective branch
vessels. In some embodiments, as mentioned, the stents can have
flanged or flared portions or be partially expanded so as to engage
the fenestrations 406, 408 such that advancing the stents into the
respective branch vessels can align the fenestrations 406, 408 with
the respective branch vessels. Additionally, in some embodiments,
the guidewires themselves can be configured to engage each of the
fenestrations 406, 408 such that, as the deployment guidewire
sheaths 420, 422 are advanced along the pre-wired guidewires into
the respective branch vessels, the fenestrations 406, 408 can be
aligned with the respective branch vessels without the use of
stents for alignment.
[0182] However, the pre-positioning of the stents and the balloons
in the endoluminal prostheses 402 described above is not required.
In some embodiments, one or more stents can be advanced through the
patient's vasculature and into the fenestrations 406, 408 after the
endoluminal prostheses 402 has been positioned within the target
vessel in the patient's vasculature. For example, one or more
stents can be advanced through the patient's vasculature into the
fenestrations 406, 408 after the main graft body 404 has been
positioned within the main target vessel or after the fenestrations
406, 408 have been positioned adjacent to the target branch
vessels.
[0183] With reference to FIGS. 20 and 21, the delivery catheter 400
can have an outer sheath 430, a distal tip 432 having a lumen or
opening 434 therethrough, and a central tube 436 that can secure
the distal tip 432 to the delivery catheter 400. The opening 434 in
the distal tip 432 can extend through the central tube 436 so that
the delivery catheter 400 can be advanced over a pre-positioned
guidewire. The outer sheath 430 can be axially moveable relative to
the central tube 436 and the distal tip 432, so that the
endoluminal prosthesis 402 can be exposed and deployed from the
delivery catheter 400 by retracting the outer sheath 430 relative
to the central tube 436 and the distal tip 432.
[0184] The distal tip 432 can be made from a soft material and/or
otherwise be configured to be atraumatic to the patient's
vasculature so as to minimize injury to the patient's vasculature
during advancement of the delivery catheter 400 through the
patient's vasculature. In some embodiments, the distal tip 432 can
have a substantially circular cross-section along the length
thereof, as illustrated in FIG. 22A, which is a section view of an
embodiment of a distal tip 432, taken through line 22A-22A in FIG.
20. As illustrated, the distal tip 432 can be tapered along a
portion of the length thereof.
[0185] In some embodiments, the distal tip 432 can have a
cross-section that is generally circular, as illustrated in FIG.
22A. In some embodiments, as illustrated in FIG. 22B, the distal
tip 432' can have a non-circular cross-section. FIG. 22B is a
section view of another embodiment of a distal tip 432' that can be
used with the embodiment of the delivery catheter 400 that is
illustrated in FIG. 20, taken through line 22B-22B in FIG. 20. For
example, as illustrated, the distal tip 432' can have one or more
channels 438 formed along a portion of the length of the distal tip
432'. The one or more channels 438 (two being shown) can each be
configured to receive a guidewire sheath 420, 422 therein. For
example, with reference to FIG. 22B, the two channels 438 can be
configured to releasably receive each of the guidewire sheaths 420,
422 therein so as to reduce the cross-sectional profile of the
delivery catheter 400 and to permit the outer sheath 430 to be
advanced over the distal tip 432 with the guidewires positioned
adjacent to the distal tip 432 and advancing beyond the distal tip
432 without obstruction from the guidewire sheaths 420, 422. For
example, the channels 438 can be configured so that the outer
sheath 430 can be advanced over and fit closely around the distal
tip 432.
[0186] FIG. 23A is a section view of the embodiment of the delivery
catheter 400 shown in FIG. 20, taken through line 23A-23A in FIG.
20. FIG. 23B is a section view of the embodiment of the delivery
catheter 400 shown in FIG. 20, taken through line 23B-23B in FIG.
20. FIGS. 23A and 23B represent different embodiments of the
delivery catheter 400. With reference to FIG. 23A, some embodiments
of the delivery catheter 400 can have an outer sheath 430 that can
be advanced through an introducer sheath 444 and an inner core 446
that can be axially advanced relative to the outer sheath 430. Some
embodiments of the delivery catheter 400 can be configured so that
the inner core 446 can be rotated relative to the outer sheath 430,
or can be configured so that the inner core 446 can be rotationally
linked to the outer sheath 430. Additionally, the inner core 446
can be configured to axially support the central tube 436 and,
hence, the distal tip 432 so that, as the inner core 446 is
advanced relative to the outer sheath 430, the central tube 436 and
the distal tip 432 can be simultaneously advanced relative to the
outer sheath 430.
[0187] Further, with reference to FIG. 23A, a lumen 450 can be
formed axially through at least a portion of the inner core 446,
the lumen 450 being configured to slideably receive a guidewire 452
therein. In some embodiments, the lumen 450 can be in communication
with the opening 434 that can be formed through the distal tip 432
and the central tube 436 such that the opening 434 and the lumen
450 can slidingly receive a pre-positioned guidewire as the
delivery catheter 400 is advanced over the guidewire. Similarly, a
lumen 454 can be formed through at least a portion of the inner
core 446 as illustrated in FIG. 23A, the lumen 454 being configured
to slideably receive a guidewire, release wire, or other wire 456
therein.
[0188] In some embodiments, the endoluminal prosthesis 402 can be
similar to or have any of the features of the endoluminal
prostheses disclosed in U.S. patent application Ser. No.
12/101,863, filed on Apr. 11, 2008 (entitled "BIFURCATED GRAFT
DEPLOYMENT SYSTEMS AND METHODS"), which is hereby incorporated by
reference in its entirety as if fully set forth herein. In some
embodiments, the release wire 456 can be or can be connected to the
sheath release wire 166 used to deploy the main branch sheath 186
in U.S. patent application Ser. No. 12/101,863.
[0189] A lumen 460 having one or more lobes can be formed axially
through at least a portion of the inner core 446. The lumen 460 can
be configured to receive one or more guidewires or guidewire
sheaths therein. In the illustrated embodiment, the lumen 460 can
be configured to receive two guidewire sheaths therein, such as
without limitation guidewire sheaths 420, 422. Additionally, in
some embodiments, the guidewire sheaths 420, 422 each can be
configured to receive a guidewire catheter therein, such as without
limitation guidewire catheters 464, 466, respectively, having
guidewires 468, 470 therein. In some embodiments, the guidewire
sheaths 420, 422 can each be sized and configured to axially
receive a renal, covered or bare metal stent therein so that a
renal stent can be advanced through the guidewire sheaths 420, 422
and deployed in the renal branch arteries as described herein. In
some embodiments, the renal stents (not illustrated) can be
advanced over the guidewire catheters 464, 466 within the guidewire
sheaths 420, 422.
[0190] In some embodiments, the hollow guidewire sheaths 420, 422
can slide within the lumen 460. Alternatively, in some embodiments,
the hollow guidewire sheaths 420, 422 can be fixed to the inner
core 446. The guidewire catheters 464, 466 can each be configured
to receive a pre-positioned guidewire therein, so that the
guidewire catheters 464, 466 can be advanced over pre-positioned
guidewires routed into the renal arteries as the delivery catheter
400 is advanced over the pre-positioned guidewire 452.
[0191] Similarly, with reference to FIGS. 23B, in some embodiments,
the delivery catheter 400 can have an outer sheath 430 that can be
advanced through an introducer sheath 444 and an inner core 446'
that can be axially advanced relative to the outer sheath 430. In
some embodiments, the delivery catheter 400 can be configured so
that the inner core 446' can be rotated relative to the outer
sheath 430, or can be configured so that the inner core 446' can be
rotationally linked to the outer sheath 430. Additionally, the
inner core 446' can be configured to axially support the central
tube 436 and, hence, the distal tip 432 so that, as the inner core
446' is advanced relative to the outer sheath 430, the central tube
436 and the distal tip 432 can be simultaneously advanced relative
to the outer sheath 430.
[0192] Further, with reference to FIG. 23B, a lumen 450 can be
formed axially through at least a portion of the inner core 446',
the lumen 450 being configured to slideably receive a guidewire 452
therein. In some embodiments, the lumen 450 can be in communication
with the opening 434 that can be formed through the distal tip 432
and the central tube 436 such that the opening 434 and the lumen
450 can slidingly receive a pre-positioned guidewire as the
delivery catheter 400 is advanced over the guidewire. Similarly, a
lumen 454 can be formed through at least a portion of the inner
core 446' as illustrated in FIG. 23B, the lumen 454 being
configured to slideably receive a guidewire, release wire, or other
wire 456 therein.
[0193] In some embodiments, one or more channels 460' can be formed
axially on at least a portion of the inner core 446'. The channels
460' can each be configured to receive one or more guidewires or
guidewire sheaths therein. In the illustrated embodiment, the
channels 460' can be configured to receive two guidewire sheaths
therein, such as without limitation guidewire sheaths 420, 422,
configured as described above. The guidewire catheters 464, 466 can
each be configured to receive a pre-positioned guidewire therein,
so that the guidewire catheters 464, 466 can be advanced over
pre-positioned guidewires routed into the renal arteries as the
delivery catheter 400 is advanced over the pre-positioned guidewire
452.
[0194] With reference to FIGS. 24-28, some non-limiting examples of
delivery methods for delivering some embodiments of the endoluminal
prostheses disclosed herein to the abdominal aortic region will be
described. FIG. 24 is a side view of an embodiment of a delivery
catheter, such as without limitation delivery catheter 400
described above, showing a delivery catheter 400 being advanced
distally past a bifurcated prosthesis 480 and showing guidewire
sheaths 420, 422 being advanced into the renal arteries.
[0195] With reference to FIG. 24, after the bifurcated prosthesis
480 has been deployed in the abdominal aorta following any suitable
methods for such deployment, including without limitation the
deployment methods disclosed in U.S. patent application Ser. No.
12/390,346 or U.S. patent application Ser. No. 12/101,863, the
delivery catheter 400 can then be advanced through the main body of
the bifurcated prosthesis 480 into the abdominal aorta and renal
artery region.
[0196] In some embodiments, the guidewire sheaths 420, 422 can be
advanced along pre-positioned guidewires into the renal arteries.
In some embodiments, as illustrated in FIG. 24, the outer sheath
430 can be partially retracted so that the guidewire sheaths 420,
422 can be advanced into the renal arteries as the distal tip 432
of the delivery catheter 400 is advanced past the renal arteries
along guidewire 452. Thereafter, the pre-placement guidewires (if
any) positioned within the guidewire sheaths 420, 422 and already
advanced into the renal arteries can be removed.
[0197] As illustrated in FIG. 25, which is a side view of the
embodiment of the delivery catheter 400 shown in FIG. 24, biased
guidewires 482, 484, which will be described in greater detail
below, can be advanced through the guidewire sheaths 420, 422 and
into the renal arteries. As will be described, the coiled distal
end portions 482a, 484a of each of the biased guidewires 482, 484
can be configured to be insertable into a branch vessel and can be
biased to remain in the branch vessel.
[0198] FIG. 26 is a side view of the embodiment of the delivery
catheter 400 shown in FIG. 24, showing the embodiment of the
endoluminal prosthesis 402 being deployed within the target vessel
region. In some embodiments, the endoluminal prosthesis 402 can be
a fenestrated cuff. The endoluminal prosthesis 402 can be deployed
by any suitable method, such as without limitation removing a
restraining sheath or by any of the methods disclosed in U.S.
patent application Ser. No. 12/390,346 or U.S. patent application
Ser. No. 12/101,863, each of which are hereby incorporated by
reference as if fully set forth herein.
[0199] For example, without limitation, the endoluminal prosthesis
402 can be deployed by removing a perforated sheath using a sheath
release wire threaded through perforations in the sheath, such as
is set forth in some embodiments of U.S. patent application Ser.
No. 12/101,863, which application is fully incorporated herein by
reference. Additionally, in some embodiments, the proximal end
portion of the endoluminal prosthesis 402 can be deployed by
distally advancing a sheath or other restraint so as to deploy the
proximal end of the endoluminal prosthesis 402 (i.e., the end of
the endoluminal prosthesis 402 that is furthest advanced into the
vasculature or closest to the heart).
[0200] The proximal end of the endoluminal prosthesis 402 can be
deployed proximal to the desired visceral vessel (such as, without
limitation, the SMA) and then axially retracted until the proximal
portion of the endoluminal prosthesis 402 is positioned just below
the target visceral vessel (e.g., without limitation, the SMA). The
adjustable fenestrations 406, 408 can then be adjusted to be
positioned adjacent to the respective renal arteries. Thereafter,
the distal portion of the endoluminal prosthesis 402 (i.e., the
portion of the endoluminal prosthesis 402 furthest away from the
heart) can be deployed within the bifurcated prosthesis 480 by
retracting the outer sheath 430, as is illustrated in FIG. 27. FIG.
27 is a side view of the embodiment of the delivery catheter 400
shown in FIG. 24, showing the endoluminal prosthesis 402 after the
distal portion of the endoluminal prosthesis 402 has been deployed
within the bifurcated prosthesis 480.
[0201] As further illustrated in FIG. 27, the inner core 446,
distal tip 432, and central tube 436 can be axially retracted
through the outer sheath 430 and removed from the target vessel
region, leaving the guidewire sheaths 420, 422 positioned within
the patient's renal arteries. In some embodiments, the delivery
catheter 400 illustrated in FIG. 23B can be configured such that
the inner core 446, distal tip 432, and central tube 436 can be
axially retracted through the outer sheath 430 while leaving the
guidewire sheaths 420, 422 positioned within the renal arteries.
Thereafter, any suitable renal stents (such, as without limitation,
stents 314, 316 described above) can be advanced through the
guidewire sheaths 420, 422 and deployed within the renal arteries
over the biased guidewires 482, 484 or other guidewires in the
renal arteries. In some embodiments, with reference to FIG. 28,
renal stents (such as without limitation stents 314, 316) can be
advanced through the guidewire sheaths 420, 422 and deployed within
the renal arteries over the biased guidewires 482, 484 or any other
guidewires without removing the inner core 446, distal tip 432, and
central tube 436.
[0202] FIG. 29 is a side view of another embodiment of a delivery
catheter 500 showing a delivery catheter 500 being advanced
distally past branch arteries in the thoracic aorta region of a
patient's vasculature. FIG. 30 is a side view of an endoluminal
prosthesis 502 that can be deployed using the embodiment of the
delivery catheter 500 shown in FIG. 29. In some embodiments, the
endoluminal prosthesis 502 can have a main graft body 504 having
multiple fenestrations 506, 508, 510 formed therein. The delivery
catheter 500 can have an outer sheath 514 and a distal tip 516
configured to be advanced over a guidewire 518, as with the other
embodiments of the delivery catheters disclosed herein.
[0203] The endoluminal prosthesis 502 and delivery catheter 500 can
have any of the components, features, or other details of any of
the other endoluminal prostheses or delivery catheters disclosed
(directly or by incorporation by reference) herein. For example, in
some embodiments, the endoluminal prosthesis 502 can have stents or
stent segments deployed within the main graft body 504, springs, or
other suitable structures deployed or supported within the main
graft body 504. Additionally, in some embodiments, the main graft
body 504 can have an enlarged diameter along at least a portion of
the main graft body 504 and/or an additional graft material or
length along at least a portion of the main graft body 504 to
improve the adjustability of the fenestrations 506, 508, 510.
[0204] In some embodiments, the delivery catheter 500 and the
endoluminal prosthesis 502 can be configured such that a guidewire
sheath (such as without limitation guidewire sheaths 420) can be
pre-positioned within the delivery catheter 500 and the endoluminal
prosthesis 502, the guidewire sheaths (not illustrated in FIGS. 29,
30) advancing through each of the fenestrations 506, 508, 510. The
distal tip 516 of the delivery catheter can be configured to have
channels formed therein configured to receive the guidewire
sheaths, similar to the distal tip 432' disclosed herein.
[0205] In some embodiments, the branch arteries can be pre-wired
with guidewires 520, 522, 524 (which can be biased guidewires),
similar to any of the pre-wiring techniques for the renal arteries
disclosed herein, so that the delivery catheter 500 and the
endoluminal prosthesis 502 having guidewire sheaths positioned
therein can be advanced over the guidewires 520, 522, 524 to
approximately align the fenestrations 506, 508, 510 as the
endoluminal prosthesis 502 is being advanced into the target vessel
region. Additionally, in some embodiments, the guidewire sheaths
can be advanced into the branch arteries as the endoluminal
prosthesis 502 is being deployed, similar to the deployment of the
aortic grafts disclosed herein. Thereafter, any suitable branch
stents (such as without limitation stents 314, 316) can be advanced
through the guidewire sheaths (not illustrated) and deployed within
the branch arteries over the guidewires 520, 522, 524.
[0206] FIG. 31 is a section view of an embodiment of a guidewire
700, showing the guidewire 700 in the open or collapsed
configuration. FIG. 32 is a section view of the embodiment of the
guidewire 700 shown in FIG. 31, showing the guidewire 700 in the
closed or expanded configuration. In some embodiments, without
limitation, the guidewire 700 can be used in place of either of the
guidewires 340, 342 shown in FIG. 19 and described above. Any of
the guidewires disclosed herein can comprise a shape memory
material, such as without limitation Nitinol.
[0207] In some embodiments, the guidewire 700 can have an outer
guidewire sheath 702 having an expandable portion 704.
Additionally, the guidewire 700 can have an inner guidewire core
706 slidably received within a lumen formed within the outer
guidewire sheath 702. In some embodiments, the outer guidewire
sheath 702 can be sized and configured such that the guidewires
310, 312 described above or any other guidewires or lumens can be
advanced over the outside of the outer guidewire sheath 702, as
described above.
[0208] With reference to FIG. 31, the expandable portion 704 can be
configured such that, when the expandable portion 704 is axially
collapsed, the diameter of the expandable portion 704 can increase
and be configured such that, when the expandable portion 704 is
axially extended, the diameter of the expandable portion 704 can
decrease. For example, with reference to FIG. 31, as the inner
guidewire core 706 is advanced relative to the outer guidewire
sheath 702 in the direction represented by arrow A1 in FIG. 31, the
expandable portion 704 can be axially extended, thus reducing the
diameter of the expandable portion 704. In contrast, with reference
to FIG. 32, as the inner guidewire core 706 is retracted relative
to the outer guidewire sheath 702 in the direction represented by
arrow A2 in FIG. 32, the collapsible portion can be axially
compressed, thus increasing the diameter of the expandable portion
704. In some embodiments, the expandable portion 704 can have a
bellows type, undulating, or corrugated outer surface.
[0209] In this arrangement, the guidewire 700 can be advanced
through the patient's vasculature to the target branch vessel while
the guidewire 700 is in the collapsed configuration (i.e., the
configuration shown in FIG. 31). When the distal end portion of the
guidewire 700 has reached the desired position within the branch
vessel, the inner guidewire core 706 can then be retracted relative
to the outer guidewire sheath 702 (i.e., retracted in direction A2
relative to the outer guidewire sheath 702) so that the diameter of
the expandable portion 704 can be increased and expand radially
against the inner surface of the branch vessel wall. In this
arrangement, the expandable portion 704 can secure the distal end
portion of the guidewire 700 in the desired branch vessel. The
expandable portion 704 can be formed from a soft, atraumatic
material to minimize the risk of any injury to the vessel wall.
[0210] FIGS. 33 and 34 each illustrate a pair of guidewires 700
positioned within the patient's vasculature such that the distal
end portions of the guidewires 700 can be secured at least
partially within the patient's branch vessels. In some embodiments,
the guidewires 700 can be positioned within the patient's
vasculature such that a portion of the expandable portion 704
protrudes into the lumen of the main vessel, which a portion of the
expandable portion 704 protrudes into the branch vessel. In FIG.
34, the distal end portion of the guidewires 700 have been advanced
further as compared to the guidewires 700 shown in FIG. 33, to
allow additional space for the deployment of branch grafts within
the branch vessels. The expandable portion 704 can be formed from
metal, plastic, or any other suitable material, and can have an
expandable bellows configuration or can be formed from one or more
braids of wire. Additionally, in some embodiments, the expandable
portion 704 can be used to align the fenestrations or branch grafts
with the branch vessels.
[0211] Once the guidewires 700 have been secured in the desired
branch vessels, any of the deployment catheters described above can
then be advanced over the guidewires 700. When the graft deployment
procedure is complete and the guidewires 700 are no longer needed
in the branch vessels, the guidewire core 706 can then be retracted
relative to the outer sheath 702 of the guidewires 700 so that the
guidewires 700 can be removed from the patient's vasculature.
Alternatively, other securing mechanisms can be attached to the
distal end portion of the guidewire, such as, without limitation,
hooks, barbs, or other similar features, to removably secure one or
more of the guidewires 700 within the vessel.
[0212] For example, in some embodiments, one of more of the
guidewires disclosed herein (such as, without limitation,
guidewires 700) can have a coiled distal end portion. The coiled
distal end portion can be configured to be insertable into a branch
vessel and can be biased to remain in the branch vessel. For
example, in some embodiments, the size or diameter of the coils can
be greater than the inside diameter of the branch vessel so as to
bias the coiled portion to remain within the branch vessel when the
proximal end of the guidewire is retracted. In this configuration,
proximal retraction of the guidewire can cause a proximal end of
the coil to unravel, allowing a portion of the coiled portion of
the guidewire to be unraveled and retracted while the remaining
portion of the coiled portion can remain within the branch vessel.
This configuration can inhibit the distal end portion of the
guidewire from being inadvertently removed from the branch vessel.
To completely remove the coiled distal end portion from the branch
vessel, the guidewire can be retracted until the entire coiled
portion is unraveled and retracted. In some embodiments (not
illustrated), the inner guidewire core 706 of the guidewire 700 can
be configured such that, when the distal end of the inner guidewire
core 706 is advanced beyond the distal end of the outer guidewire
sheath 702, the distal end of the inner guidewire core 706 forms
its coils that expand against the inner vessel wall and secure the
guidewire 700 to the branch vessel.
[0213] FIG. 35 is a side view of another embodiment of an
expandable guidewire 720, showing the guidewire 720 in an expanded
configuration. The guidewire 720 can have expansion struts 722 that
can expand when deployed in the renal or other branch arteries. In
some embodiments, the guidewire 720 can be formed from a tube of
Nitinol that can be perforated or cut so as to form a plurality of
axial members or struts 722, and heat set so that the expansion
struts 722 form a size that is larger than the desired vessel
diameter. In some embodiments, the guidewire can have four or less,
or six, or eight or more struts 722.
[0214] In some embodiments, the guidewire 720 can be advanced
through a tubular guidewire sheath that terminates in the desired
branch vessel location. As the expansion struts 722 exit the distal
end of the tubular guidewire sheath, the expansion struts 722 can
self-expand against the walls of the target vessel so as to bias
the guidewire 720 in the desired location. Alternatively, a two-way
guidewire (i.e., one having sufficient compressive and tensile
strength) can be advanced through the hollow guidewire 720 so as to
elongate and, hence, radially collapse the expansion struts 722. In
some embodiments, the guidewire 722 can have a coiled end portion
724 to be more atraumatic.
[0215] FIG. 36 is a side view of another embodiment of a guidewire
730, showing the guidewire 730 in an expanded configuration. The
guidewire 730 can have a coiled expansion portion 732 that can
expand when deployed in the renal or other branch arteries. In some
embodiments, the guidewire 730 can be formed from a tube of Nitinol
that can be formed so as to define a coiled expansion portion, and
heat set so that the coiled expansion portion 732 defines a
diameter that is larger than the desired vessel diameter. The force
from the coiled expansion portion 732 expanding against the vessel
wall can provide a frictional force that inhibits the guidewire
from being inadvertently removed from the target branch vessel. In
some embodiments, the coiled expansion portion 732 can have two or
more, or four or more coils.
[0216] In some embodiments, the guidewire 730 can be advanced
through a tubular guidewire sheath that terminates in the desired
branch vessel location. As the coiled expansion portion 732 exits
the distal end of the tubular guidewire sheath, the coiled
expansion portion 732 can self-expand against the walls of the
target vessel so as to bias the guidewire 730 in the desired
location. Alternatively, a two-way guidewire (i.e., one having
sufficient compressive and tensile strength) can be advanced
through the guidewire 730 so as to elongate and, hence, radially
collapse the coiled expansion portion 732.
[0217] FIG. 37 is a section view of another embodiment of a
guidewire 740, showing the guidewire 740 in an expanded
configuration. The guidewire 740 can have a braided or wire
expansion portion 742 that can expand when deployed in the renal or
other branch arteries. In some embodiments, the guidewire 740 can
be formed from a tube of Nitinol that can be formed so as to define
a coiled expansion portion, and heat set so that the braided or
wire expansion portion 742 defines a diameter that is larger than
the desired vessel diameter. The expansion portion 742 can be
formed from between approximately five and ten or more wires each
having a diameter between approximately 0.003 in or less and
approximately 0.005 in or more. In some embodiments, the expansion
portion 742 can be formed from between approximately three and
twelve or more wires. The force from the expansion portion 742
expanding against the vessel wall can provide a frictional force
that inhibits the guidewire from being inadvertently removed from
the target branch vessel.
[0218] In some embodiments, the guidewire 740 can be advanced
through a tubular guidewire sheath that terminates in the desired
branch vessel location. As the expansion portion 742 exits the
distal end of the tubular guidewire sheath, the expansion portion
742 can self-expand against the walls of the target vessel so as to
bias the guidewire 740 in the desired location. Alternatively, a
two-way guidewire (i.e., one having sufficient compressive and
tensile strength) can be advanced through the guidewire 740 so as
to elongate and, hence, radially collapse the expansion portion
742.
[0219] FIG. 38 is a side view of another embodiment of an
endoluminal prosthesis 745, showing the branch grafts 750 in an
inverted position inside the main body 748 of the prosthesis, 745.
FIG. 39 is a side view of the embodiment of the prosthesis 745
shown in FIG. 38, showing the branch grafts 750 in an inverted
position inside the main body 748 of the prosthesis 745 and showing
an embodiment of an angiographic catheter 751 being advanced
through each of the inverted branch grafts 750 and the
fenestrations 749. Some embodiments of the angiographic catheter
751 can be configured such that an end portion thereof is biased to
have a curved disposition. In some embodiments, this can be
accomplished by shortening the length of the wall of one side of
the end portion of the angiographic catheter 751 as compared to the
length of the wall of the other side of the angiographic catheter
751.
[0220] Some embodiments of the endoluminal prosthesis 745 can have
a main graft body 748 having fenestrations or openings 749 therein
and branch grafts 750 supported by the main graft body 748. Though
not required, an additional fenestration can be formed in a first
portion 748a of the main graft body 748 to accommodate blood flow
to the SMA or otherwise. Alternatively, a branch graft (not
illustrated) can be supported by the main graft body 748 to
accommodate the blood flow to the SMA.
[0221] The endoluminal prosthesis 745 illustrated in FIG. 38 can
have any of the same features, components, or other details as
compared to any of the embodiments of the endoluminal prostheses
disclosed (directly or by incorporation by reference) herein,
including without limitation the embodiment of the endoluminal
prosthesis 100 illustrated in FIG. 10 and described above. As with
the endoluminal prosthesis 100 illustrated in FIG. 10 above, to
accommodate positional adjustability of the branch grafts 750, the
branch grafts 750 can be supported by the second or enlarged
portion 748b of the main graft body 748.
[0222] In some embodiments, the branch grafts 750 can be integrally
formed with the main graft body 748. Alternatively, the branch
graft portions 750 can be formed separately and later attached,
adhered, sutured, or otherwise fastened or supported by the main
graft body 748. Additionally, in some embodiments, before the
endoluminal prostheses 745 is loaded into a delivery catheter,
angiographic catheters 751 or hollow guidewires can be advanced
through the branch grafts 750 and fenestrations 749. As is
illustrated, in some embodiments, the angiographic catheters 751
can define a lumen therethrough so that they can be passed or
advanced over guidewires 752 that are pre-wired in the patient's
vasculature to guide the endoluminal prostheses 745 to the target
location. Advancing the angiographic catheters 751 over the
pre-wired guidewires 752 can also facilitate the alignment of each
of the branch grafts 750 with each of the branch vessels in the
patient's vasculature.
[0223] As illustrated, in some embodiments, the branch grafts 750
can be inverted and positioned within the main body 748 of the
prosthesis 745 during the initial steps of deployment of the
prosthesis 745. In some embodiments of this configuration, the
prosthesis 745 may be easier to advance to and deploy at the target
vessel location when the branch grafts 750 are inverted and
positioned within the main body 748 of the prosthesis 745.
Additionally, in some embodiments, the prosthesis may be configured
such that the branch grafts 750 can be advanced through the
fenestrations 749 in the main body 748 of the prosthesis 745 and
into the desired branch vessels after the main body 748 of the
prosthesis 745 has been positioned in the target vessel
location.
[0224] In some embodiments, one or more stents 757 can be deployed
or expanded within the branch grafts 750 after the branch grafts
have been advanced into the branch vessels. The stents 757, or any
other stents disclosed (directly or by incorporation by reference)
herein, can be balloon expandable, self-expandable, flared,
flareable, or be of any other suitable configuration or material,
and can be carried or supported within a guidewire catheter sheath
754. With reference to the figures, the prosthesis 745 can be
configured such that the stents 757 are affixed to an end portion
of the branch grafts 750 such that the branch grafts 750 can be
inverted and advanced through the fenestrations 749 found in the
main graft body 748 and into the branch vessels by advancing the
stents 757 distally through the guidewire catheter sheath 754. In
some embodiments, the stents 757 can be advanced distally through
the guidewire catheter sheath 754 by advancing a pusher catheter
755 that is radially supported but axially unrestrained within the
guidewire catheter sheath 754.
[0225] FIG. 40 is a section view of the embodiment of the
prosthesis 745 shown in FIG. 38, taken through line 40-40 in FIG.
39. With reference to FIG. 40, the angiographic catheters 751 can
be configured to be axially advanceable over the guidewires 752.
Further, a pusher catheter 755 can be housed within each guidewire
catheter sheath 754 so as to be axially advanceable over each
angiographic catheter 751 and within the guidewire catheter sheath
754.
[0226] FIG. 41 is a section view of the embodiment of the
prosthesis 745 shown in FIG. 40, taken through line 41-41 in FIG.
39. With reference to FIG. 41, the angiographic catheter 751 can be
configured to be axially advanceable over a guidewire 752. Further,
the stents 757 can be housed within the guidewire catheter sheath
754 so as to be axially advanceable over the angiographic catheter
751 and within the guidewire catheter sheath 754. FIG. 42 is a
section view of the embodiment of the prosthesis 745 shown in FIG.
38, after the branch grafts 750 have been advanced through the
fenestrations 749 in the main body 748 of the embodiment of the
prosthesis 745 shown in FIG. 38.
[0227] In some embodiments, the angiographic catheters 751 can be
made from a plastic extrusion or metal braids. For example, in some
embodiments, the hollow angiographic catheters 751 can be made from
braided Nitinol wire. In some embodiments, the outer diameter of
the angiographic catheters 751 can be approximately 0.035 in and
the lumen of the guidewire can be approximately 0.016 in to
accommodate a second 0.014 in guidewire. In some embodiments, the
angiographic catheters 751 can be configured to pass over a 0.018
in or any other suitable guidewire. In some embodiments, the outer
diameter of the angiographic catheters 751 can be approximately 5
Fr and the lumen of the guidewire can be approximately 0.040 in to
accommodate a second 0.035 or 0.038 in guidewire. In some
embodiments, the angiographic catheters 751 can be configured to
pass over a 0.018 in or any other suitable guidewire. In some
embodiments, the angiographic catheters 751 can be configured to
support balloons on the distal ends of the angiographic catheters
751. The balloons can be inflated in the branch vessel to deploy
expandable stents such as stents 757 within the branch grafts
750.
[0228] In some embodiments, each of the stents 757 can be a bare
metal stent or a covered stent (i.e., covered with a tubular shaped
graft material). Additionally, in some embodiments, the stents 757
can be self expanding or can be balloon expandable. Although not
required, each branch graft 750 can be fixed at an end portion
thereof to an end portion of each stent 757. In some embodiments,
each of the stents 757 can be supported by or positioned over an
expansion balloon positioned within each of the guidewire catheter
sheaths 754. The balloons can be slideable within the guidewire
catheter sheaths 754 so that the balloons can be advanced distally
simultaneously with the stents 757. In some embodiments, the
balloons can be slideable over the angiographic catheters 751 so
that the balloons can be advanced over the angiographic catheters
751 as the stents 757 are advanced over the angiographic catheters
751. The balloons can be expanded to deploy the stents 757 once the
stents 757 are positioned in the target location within the branch
vessels.
[0229] Alternatively, in some embodiments, the angiographic
catheters 751 can be retracted after the stents 757 are positioned
in the target location within the branch vessels. Thereafter, one
or more balloons supported by a guidewire catheter, balloon
catheter, or other suitable catheter can be advanced over the
guidewires 752 and into the branch vessels to expand or otherwise
deploy the stents 757.
[0230] Accordingly, in some embodiments, the angiographic catheters
751 can be configured to allow for the inflation and expansion of
expansion balloons so as to expand or deploy the branch stents 757.
For example, the angiographic catheters 751 can have a first lumen
that can be advanced over a pre-wired guidewire and a second
inflation lumen configured to communicate a positive pressure to
the expansion balloon or balloons.
[0231] In some embodiments, the endoluminal prostheses 745 can be
loaded into a delivery catheter so that each of the angiographic
catheters 751 protrudes out from the inside of the guidewire
catheter sheath 754 so that each of the angiographic catheters 751
can be advanced over the pre-wired guidewires 752 positioned within
the patient's vasculature. Thus, during deployment, in some
embodiments, each of the stents 757 can be expanded and, hence,
deployed within each of the branch grafts 750 after each of the
branch grafts 750 has been advanced into the respective branch
vessels. In some embodiments, each of the stents 757 can be
expanded and, hence, deployed within each of the branch grafts 750
before the main graft body 748 has been secured in the main target
vessel.
[0232] However, as mentioned, the pre-positioning of the stents 757
and/or the balloons in the endoluminal prostheses 745 described
above is not required. In some embodiments, one or more stents can
be advanced through the patient's vasculature and into the branch
grafts 750 after the endoluminal prostheses 745 has been positioned
within the target vessel in the patient's vasculature. For example,
one or more stents can be advanced through the patient's
vasculature into the branch grafts 750 after the branch grafts 750
have been inverted and advanced into the target branch vessels and
after the main graft body 748 has been secured within the main
target vessel.
[0233] In some embodiments, the hollow angiographic catheters 751
can pass through a distal end opening of an outer sheath of a
deployment catheter, just as with the delivery catheter 330
described above. As mentioned, each of the hollow angiographic
catheters 751 can be configured to receive or allow the insertion
of a 0.014 in guidewire, a 0.018 in guidewire, a 0.035 in
guidewire, or any diameter guidewire therethrough deemed suitable
for the design. In some embodiments, the outer diameter of the
angiographic catheters 751 can be approximately 5 Fr and the lumen
of the guidewire can be approximately 0.040 in to accommodate a
second 0.035 or 0.038 in guidewire. In some embodiments, the
angiographic catheters 751 can be configured to pass over a 0.018
in or any other suitable guidewire. In this configuration, the
hollow angiographic catheters 751 can pass over guidewires 752 that
can be pre-wired in the target vessels so that the deployment
catheter housing the prosthesis 745 can be advanced along the
guidewires 752 pre-wired in the patient's vasculature, similar to
any of the other embodiments of the deployment catheters disclosed
or incorporated by reference herein or any other suitable catheter
configurations known in the field.
[0234] In some embodiments, once the endoluminal prosthesis 745 has
been advanced to the target location along the guidewires 752
within the patient's vasculature, the guidewire catheter sheaths
755 and the pusher catheters 755 can be advanced through each of
the fenestrations 749 in the main body 748 of the prosthesis 745.
Advancing the guidewire catheter sheaths 755 and the pusher
catheters 755 through each of the fenestrations 749 in the main
body 748 of the prosthesis 745 can cause each branch graft 750 to
be advanced through the fenestrations 749 and to invert and slide
over an end portion of each guidewire catheter sheath 755 and slide
around an outside surface of each guidewire catheter sheath 755, so
that each branch graft 750 can extend in the appropriate
orientation in each of the branch vessels.
[0235] In this arrangement, an end portion of the guidewire
catheter sheath 755 can be positioned within the branch graft 750
after the branch graft 750 has been advanced into the branch vessel
as described above. Thereafter, in some embodiments, the pusher
catheter 755 can be used to hold the stent 757 in the target
location while the guidewire catheter sheath 755 is retracted. If
the stent 757 is self-expandable, retracting the guidewire catheter
sheath 755 will permit the stent 757 to self-expand radially
outwardly, thereby securing the branch graft 750 in the target
location. If the stent 757 is not self-expandable, the angiographic
catheter 751, a balloon catheter, or other suitable instrument can
be used to expand and deploy the stent 757 in the target location.
Each of the branch grafts 750 can be deployed sequentially or
simultaneously in this arrangement. A stent or other suitable
device can be deployed within the main graft body 748 to secure the
main graft body 748 within the main vessel.
[0236] As mentioned, although not required, each branch graft 750
can be fixed at an end portion thereof to an end portion of each
stent 757. In some embodiments, an end portion of the branch graft
750 can be affixed to at least a proximal end portion of the
respective stent 757 so that the branch graft 250 can substantially
completely cover an inside and an outside surface of the stent 757
after the branch graft 750 has been inverted and advanced into the
branch vessel.
[0237] Additionally, in some embodiments, one or more of the
pre-wired guidewires 752 described above can be configured to be
insertable into a branch vessel and to be biased such that an end
portion of the guidewires 752 remains in the branch vessel, such as
with any of the guidewires. In particular, one or more of the
guidewires 752 can be configured to have the same features as,
without limitation, any of guidewires 700, 720, 730, or 740
disclosed herein.
[0238] FIG. 43A is a side view of another embodiment of a catheter
system 1000 comprising an embodiment of an introducer catheter 1002
(also referred to as an introducer) and an embodiment of a delivery
catheter 1004. The delivery catheter 1004 can be configured for the
delivery of an endoluminal prosthesis, including without limitation
any endoluminal prosthesis embodiment disclosed herein or any other
suitable prosthesis, or for any other suitable use. Therefore, the
embodiments of the catheters and introducers disclosed herein can
be configured for any suitable purpose, including deployment of a
stent graft system as described herein.
[0239] FIG. 43B is a perspective view of the embodiment of a
catheter system 1000 illustrated in FIG. 43A, showing an outer
sheath 1006 of the delivery catheter 1004 in a partially retracted
position. With reference to FIGS. 43A and 43B, some embodiments of
the outer sheath 1006 can be used to constrain at least a portion
of a prosthesis 1010. In some embodiments, the prosthesis 1010 can
have any of the same features, components, or other details of any
of the other prosthesis embodiments disclosed herein, including
without limitation the embodiments of the prosthesis 1200 described
below. The prosthesis 1010 can have any number of stents or other
support members, connectors, grafts, cuts, fenestrations, or other
suitable components or features. As used herein, when referring to
the prosthesis 1010, distal refers to the end of the prosthesis
that is further from the patient's heart, and proximal refers to
the end of the prosthesis that is closer to the patient's heart. As
used herein with regard to the embodiments of the catheter system
1000, the term distal refers to the end of the catheter system that
is further from the surgeon or medical practitioner using the
catheter system, and the term proximal refers to the end of the
catheter system that is closer to the surgeon or medical
practitioner.
[0240] In some embodiments, as illustrated in FIG. 43, a distal
sheath 1012 (also referred to herein as a first restraint or first
restraining means) can be used to constrain a proximal portion of
the stent graft 1010. The distal sheath 1012 can be supported by a
distal tip 1014 of the catheter system 1000. In some embodiments,
the distal tip 1014 can comprise an atraumatic material and design.
As will be described in greater detail below, the distal tip 1014
and, hence, the distal sheath 1012 can be attached to an inner tube
1016 to control the position of the distal tip 1014 and the distal
sheath 1012 relative to an inner core 1020 of the delivery catheter
1004. The inner core 1020 can be rotatable relative to the outer
sheath 1006 so that a prosthesis supported by the delivery catheter
1004 can be rotated during deployment. The inner tube 1016 can be
slidably positioned coaxially within a lumen in an outer tube 1018
that can connect a support member 1022 to the inner core 1020. In
some embodiments, the outer tube 1018 can be connected to an
opening or partial lumen 1019 in the inner core 1020 so as to be
axially and rotationally fixed to the inner core 1020.
[0241] In this configuration, the catheter system 1000 can be
configured such that advancing the inner tube 1016 relative to an
inner core 1020 of the delivery catheter 1004 can cause the distal
sheath 1012 to be advanced relative to the prosthesis 1010, causing
the proximal portion of the prosthesis 1010 to be deployed. The
prosthesis 1010 (or any other prosthesis disclosed herein) can be
at least partially self-expanding such that, as the tubular distal
sheath 1012 is advanced relative to the prosthesis 1010, a proximal
portion of the prosthesis 1010 expands against a vessel wall. In
some embodiments, only some segments or portions of the prosthesis
1010 such as, without limitation, portions of the prosthesis
axially adjacent to englarged graft portions of the prosthesis, can
be configured to be self-expanding.
[0242] The inner core 1020 can be slideably received within the
outer sheath 1006 of the delivery catheter 1004. In some
embodiments, as in the illustrated embodiment, the outer sheath
1006 of the delivery catheter 1004 can be longer than an introducer
sheath 1008 of the introducer catheter 1002. Further, a clip 1007
can be supported by the outer sheath 1006 to limit the range of
axial movement of the outer sheath 1006 relative to the introducer
catheter 1002.
[0243] In some embodiments, although not required, a core assembly
1021 can be connected to a proximal end portion of the inner core
1020, the core assembly 1021 having a reduced cross-sectional
profile so as to permit one or more sheath members, push catheters,
or other tubular or other components to pass through the main body
of the delivery catheter 1004 and be advanced into one or more
lumen within the inner core 1020. In some embodiments, the inner
core 1020 can be configured to accommodate the insertion of such
sheath members, push catheters, or other tubular components into
the lumen of the inner core 1020.
[0244] In the illustrated embodiment, a proximal end portion of the
core assembly 1021 can comprise a handle member 1023 that is
positioned outside a proximal end portion of the delivery catheter
1004 so as to be accessible by a user. The handle member 1023 can
be configured to permit a user to axially or rotationally adjust
the position of the inner core 1020 relative to the outer sheath
1006.
[0245] As discussed above, the inner core 1020, or components
axially connected to the inner core 1020 such as the core assembly
1021, can extend proximally past the proximal end portion 1004a of
the delivery catheter system 1004 so that a user can adjust and/or
change the axial and/or radial position of the inner core 1020 and,
hence, the prosthesis 1010, relative to the outer sheath 1006.
Similarly, the inner tube 1016 can extend proximally past the
proximal end portion 1004a of the delivery catheter 1004 and a
proximal end portion 1021a of the core assembly 1021 so that a user
can adjust and change the position of the inner tube 1016 relative
to the inner core 1020.
[0246] In the partially retracted position of the outer sheath 1006
illustrated in FIG. 43B, at least a portion of the prosthesis 1010
supported by the catheter system 1000 can be exposed and,
potentially, deployed. In some embodiments, a distal portion of the
prosthesis 1010 can be exposed and deployed by retracting the outer
sheath 1006 relative to the inner core 1020 or distally advancing
the inner core 1020 relative to the outer sheath 1006, causing at
least a portion of the distal portion of the prosthesis 1010 to
self-expand. As will be described, some embodiments of the
prosthesis 1010 can be configured to have radially self-expanding
support members therein along only a portion or portions of the
prosthesis 1010. For example, without limitation, some embodiments
of a graft of the prosthesis 1010 can be radially unsupported at or
adjacent to fenestrations formed in the graft. Alternatively, in
some embodiments, at least the distal portion of the prosthesis
1010 can be constrained within a sheath, such as a peelable sheath.
Embodiments of the sheath will be described in greater detail
below.
[0247] 102511 The delivery catheter 1004 can also have one or more
branch or guide sheaths 1024 supported thereby. In some
embodiments, the delivery catheter 1004 can have three or more
branch sheaths 1024. Such a configuration can be used for deploying
branch stents into one or more branch vessels in the thoracic
aorta. Each of the one or more branch sheaths 1024 can be
configured to be slideably supported within one or more lumen 1025
formed in the inner core 1020 so that each of the one or more
branch sheaths 1024 can be axially advanced or retracted relative
to the inner core 1020. Further, some embodiments of the delivery
catheter 1004 can be configured such that the branch sheaths 1024
can be rotationally adjusted or twisted relative to the inner core
1020. In some embodiments, each branch sheath 1024 can be
positioned within the delivery catheter 1004 such that, in the
loaded configuration wherein a prosthesis 1010 is supported within
the delivery catheter 1004, each branch sheath 1024 is
pre-positioned so as to be advanced through a fenestration or
branch graft of the prosthesis 1010. Each branch sheath 1024 can be
positioned within the delivery catheter 1004 such that a distal end
portion of each branch sheath 1024 projects past an end portion of
the inner core 1020 and is constrained within the outer sheath
1006. As illustrated in FIGS. 43A-43B, in this configuration, the
distal end portion of each branch sheath 1024 can be exposed by
retracting the outer sheath 1006 relative to the inner core 1020
and/or the branch sheaths 1024.
[0248] Additionally, with reference to FIG. 43B, in some
embodiments, although not required, the delivery catheter 1004 can
have one or more push catheters 1026 supported thereby. In some
embodiments, the one or more push catheters 1026 can be slideably
received within one or more lumen 1027 formed in the inner core
1020. In some embodiments, the one or more push catheters 1026 can
each have an end portion 1026a that can be sized and configured to
surround an outer surface of each of the branch sheaths 1024. The
end portion 1026a of each push catheter 1026 can have, without
limitation, an open or closed annular or circular shape and can be
of sufficient size and stiffness to permit a user to engage a
fenestration or branch graft formed in or supported by a main body
of the prosthesis 1010. For example, as will be described in
greater detail below, after the main body of the prosthesis 1010
has been released from the outer sheath 1006 and any other radial
restraints, a user can independently or collectively axially
advance the push catheter 1026 over the branch sheaths 1024 such
that the end portion 1026a of each push catheter 1026 engages the
fenestration or branch graft of the prosthesis 1010 and pushes the
fenestration or branch graft toward an ostium of the target branch
vessel of the patient's vasculature.
[0249] Accordingly, in this configuration, at least a portion of
each of the one or more push catheters 1026 can be configured to be
slideably supported within a lumen formed in the inner core 1020 so
that each of the one or more push catheters 1026 can be axially
advanced relative to the inner core 1020. Further, some embodiments
of the delivery catheter 1004 can be configured such that the push
catheters 1026 can be axially or rotationally adjusted or twisted
relative to the inner core 1020, for increased maneuverability of
the push catheters 1026.
[0250] In some embodiments, each push catheter 1026 can be
positioned within the delivery catheter 1004 such that, in the
loaded configuration wherein a prosthesis 1010 is supported within
the delivery catheter 1004, each push catheter 1026 is
pre-positioned so that the end portion 1026a of each push catheter
1026 is positioned distal to the end portion of the inner core
1020. In some embodiments, in the loaded configuration, each push
catheter 1026 can be positioned such that the end portion 1026a of
each push catheter 1026 is located within the main lumen of the
main body of the prosthesis 1010. As mentioned, in some
embodiments, one or more of the branch sheaths 1024 can have a
loop, protrusion, snare, or other similar feature supported
thereby, or otherwise be configured to enable the sheath 1024 to
engage a fenestration or branch graft to advance the fenestration
or branch graft toward the ostium of the target branch vessel by
advancing the branch sheath 1024.
[0251] The branch sheaths 1024 and push catheters 1026 can have any
suitable size and can be made from any suitable material. For
example, without limitation, the branch sheaths 1024 can have an
approximately 6.5 French diameter, or from an approximately 5 Fr
diameter or less to an approximately 8 Fr diameter or more, or to
or from any values within this range. The push catheters 1026 can
be formed from stainless steel, Nitinol, or any other suitable
metallic or non-metallic material, and can have a thickness
suitable to prevent the push catheters 1026 from buckling when
axially advanced against a portion of the prosthesis 1010. For
example, without limitation, the push catheters 1026 can have an
approximately 1 Fr diameter, or between approximately a 1 Fr and
approximately a 4 Fr diameter. Further, some embodiments of the
push catheter or catheters can be formed from a 0.035 in guidewire
or otherwise have a 0.035 in diameter.
[0252] Additionally, as will be described below in greater detail,
the catheter system 1000 can be configured such that the distal
sheath 1012 can be advanced relative to the inner core 1020 and the
prosthesis 1010, to expose a proximal portion of the prosthesis
1010. In particular, in some embodiments, advancing the distal
sheath 1012 can be accomplished by advancing the inner tube 1016
connected to the distal tip 1014 and the distal sheath 1012, so
that the distal sheath 1012 releases the proximal portion of the
prosthesis 1010. Other details regarding the distal sheath 1012 or
methods of using the distal sheath can be found in U.S. Pat. No.
6,953,475, which application is incorporated by reference as if
fully set forth herein.
[0253] FIGS. 44 and 45 are a perspective view and an exploded view,
respectively, of the embodiment of the introducer catheter 1002
shown in FIG. 43. In some embodiments, the introducer catheter 1002
can have any of the features or components of any of the
embodiments disclosed in U.S. patent application Ser. No.
12/496,446, which disclosure is hereby incorporated by reference as
if set forth herein. With reference to FIGS. 44-45, in some
embodiments, the introducer 1002 can have a main body 1030, a
threadably engageble hub portion 1032, a threaded cap 1034
configured to threadably engage with a threaded distal end portion
1030a of the main body 1030 so as to secure the outer sheath 1006
to the main body 1030. The outer sheath 1006 can have a flanged end
portion 1036 secured thereto or integrally formed therewith. The
main body 1030 can support a seal assembly 1040 therein to seal
around the inner core 1020 of the delivery catheter 1004 and/or
other components of the catheter system 1000. A threaded end member
1042 having a threaded proximal end portion 1042a can be supported
by the main body 1030. An annular seal member 1046 can be supported
by the main body 1030 of the introducer catheter 1002. The
introducer catheter 1002 can be configured such that the seal
member 1046 can be adjusted to provide an additional seal around
the inner core 1020 of the delivery catheter 1004 by threadedly
engaging the hub portion 1032. The seal assembly 1040 and seal
member 1046 can have any of the details, features, or components of
any of the embodiments of the introducer catheter described in U.S.
patent application Ser. No. 12/496,446, which application is
incorporated by reference as if fully set forth herein.
[0254] In some embodiments, a tube assembly 1048 can be supported
by the main body 1030 of the introducer catheter 1002 so as to
provide an orifice or access port into the main body 1030. The tube
assembly 1048 can be used to flush the introducer catheter 1002
with saline or other suitable substances at any stage, such as but
not limited to prior to the advancement of an endoluminal
prosthesis through the introducer catheter 1002 and/or delivery
catheter 1004, or prior to other procedures for which another type
of delivery catheter may be used. The tube assembly 1048 can
support any suitable medical connector and/or valve on the distal
end thereof.
[0255] FIGS. 46 and 47 are a perspective view and an exploded view,
respectively of the embodiment of the delivery catheter 1004 shown
in FIG. 43. FIG. 48 is a section view of a portion of the
embodiment of the delivery catheter 1004 shown in FIG. 43, defined
by curve 48-48 shown in FIG. 43A. FIG. 49A is a section view of the
embodiment of the delivery catheter 1004 shown in FIG. 43, defined
by the line 49A-49A shown in FIG. 48. FIG. 49B is a section view of
the embodiment of the delivery catheter 1004 shown in FIG. 43,
defined by the line 49B-49B shown in FIG. 48.
[0256] As shown therein, some embodiments of the delivery catheter
1004 can have a main body 1050 that can support the inner core 1020
and/or core assembly 1021, one or more access ports 1052 for the
one or more branch sheaths 1024, and one or more access ports 1054
for the one or more push catheters 1026. The access ports 1052,
1054 can be configured to sealingly tighten around the branch
sheaths 1024 or the push catheters 1026, and to constrict around
the branch sheaths 1024 or the push catheters 1026 so as to
substantially axially secure the branch sheaths 1024 or the push
catheters 1026. A sealable cap assembly 1051 can be threadingly
engaged with the main body 1050 of the delivery catheter 1004. The
cap assembly 1051 can be configured such that, when a user tightens
the cap assembly 1051 relative to the main body 1050 of the
delivery catheter 1004, the core assembly 1021 and/or inner core
1020 will be axially and/or rotational secured to the main body
1050 of the delivery catheter 1004.
[0257] In some embodiments, a tube assembly 1059 can be supported
by the main body 1050 of the delivery catheter 1004 so as to
provide an orifice or access port into the main body 1050. The tube
assembly 1059 can be used to flush the delivery catheter 1004 with
saline or other suitable substances. The tube assembly 1059 can
support any suitable medical connector and/or valve on the distal
end thereof.
[0258] As mentioned above, the support member 1022 can be connected
to a distal end portion of the outer tube 1018 so as to be axially
engaged by the outer tube 1018. Some embodiments of the support
member 1022 can have a substantially cylindrical shape and can be
sized to fit within the inner lumen of a main body of the
prosthesis 1010 when the prosthesis 1010 is in a constrained
configuration. As will be described, in the loaded configuration,
the prosthesis 1010 can be positioned over the support member 1022
so that a proximal portion of a main body of the prosthesis 1010 is
positioned distally of the support member 1022 and so that a distal
portion of a main body of the prosthesis 1010 is positioned
proximally of the support member 1022. In this configuration, a
proximal end portion 1012a of the distal sheath 1012 can be
positioned over a distal portion 1022a of the support member 1022,
and a distal end portion 1006a of the outer sheath 1006 over a
proximal portion 1022b of the support member 1022.
[0259] In some embodiments, one or more tab members 1074 can be
supported by the outer tube 1018. The one or more tab members 1074
can be configured to increase the rotational engagement of the
constrained prosthesis 1010 relative to the outer tube 1018 so that
the constrained prosthesis 1010 can be rotated with greater
accuracy during deployment. Some embodiments of the one or more tab
members 1074 can have a generally flat, plate-like shape, such as
is illustrated in FIG. 46. The one or more tab members 1074 can be
formed from a suitable polymeric or metallic material. Some
embodiments of the one or more tab members 1074 can comprise one or
more radiopaque features or be formed from a radiopaque material to
improve the visibility and alignability of the delivery catheter
1004 under fluoroscopy during deployment of the prosthesis
1010.
[0260] In some embodiments, the one or more tab members 1074 can be
similar to any of the embodiments of the torsion tab (such as
without limitation, the embodiment of the torsion tab 196)
disclosed in U.S. patent application Ser. No. 12/101,863, which
disclosure is incorporated by reference as if fully set forth
herein. In some embodiments, the one or more tab members 1074 can
be integrally formed with the outer tube 1018, or secured thereto
such as by thermal bonding, adhesive bonding, and/or any of a
variety of other securing techniques known in the art.
[0261] As is illustrated, the main body portion of the prosthesis
1010 can be constrained by a peelable sheath or by the outer sheath
1006 such that the prosthesis 1010 is engaged with the one or more
tab members 1074. In some embodiments, the one or more tabs 1074
can engage a stent or other portion of an endoskeleton of the
prosthesis 1010, or, in some embodiments, can engage the material
of the graft 1204 surrounding the tab member 1074 so that the
prosthesis 1010 can substantially rotate with the inner core 1020
of the deployment catheter 1004.
[0262] FIG. 50 is a side view of the embodiment of the catheter
system 1000 shown in FIG. 43, showing the outer sheath 1006 in a
partially retracted position, similar to the configuration shown in
FIG. 43B. FIG. 51 is an enlarged side view of the embodiment of the
catheter system shown in FIG. 43, defined by curve 51-51 of FIG.
50, showing the outer sheath 1006 in a partially retracted
position.
[0263] With reference to FIG. 51, in some embodiments, the mid
portion of the prosthesis 1010 adjacent to the one or more
fenestrations 1011 and/or the distal portion 1010a of the
prosthesis can be constrained within a peelable sheath 1060. The
peelable sheath 1060 can have a release wire 1062 threadably
advanced through a plurality of openings 1064 formed along at least
a portion of the sheath 1060. In some embodiments, the peelable
sheath 1060, release wire 1062, and openings 1064 can have any of
the same features, materials, or other details of the similar
components disclosed in U.S. patent application Ser. No.
12/101,863, which application is incorporated by reference as if
fully set forth herein. In some embodiments, the release wire 1062
can be slideably received within a lumen in the inner core 1020 so
that a user can retract the release wire 1062 by grasping and
retracting a proximal portion of the release wire 1062 positioned
outside the patient's body.
[0264] However, in some embodiments (not illustrated), the mid
portion of the prosthesis 1010 adjacent to the one or more
fenestrations 1011 and/or the distal portion 1010a of the
prosthesis can be constrained within one or more tubular sheaths,
such as the outer sheath 1006 (also referred to herein as a second
restraint or second restraining means) and/or distal sheath 1012
such that additional restraining means such as the sheath 1060 are
not required. Therefore, any of the embodiments disclosed herein
having the optional sheath 1060 should be understood to be
configurable to not use the sheath 1060 to restrain one or more
portions of the prosthesis 1010. In some embodiments, the
prosthesis 1010 can be configured such that the mid portion of the
prosthesis 1010 adjacent to the one or more fenestrations 1011 is
not radially supported by a stent, connectors, struts, or any other
similar structure such that, when the outer sheath 1006 is
partially retracted, the mid portion of the prosthesis does not
self-expand.
[0265] In some embodiments, the prosthesis 1010 can have one or
more openings 1011 formed therein. For example and without
limitation, the fenestrations or openings 1011 can be formed in the
prosthesis 1010 at diametrically opposing positions. As will be
described in greater detail below, in some embodiments, one or more
of the openings 1011 can be formed in the prosthesis 1010 at a
position that is angularly offset from the diametrically opposing
position. Similarly, in some embodiments, when used, the sheath
1060 can have one or more openings 1061 formed therein, the
openings 1061 being positioned adjacent to the similar number of
openings 1011 formed in the prosthesis. Some embodiments of the
catheter system 1000 can be configured such that the sheaths 1024
are advanced through the openings 1011 formed in the prosthesis
1010 and the openings 1061 formed in the sheath 1060, when the
prosthesis 1010 is loaded within the catheter system 1000.
[0266] With reference to FIG. 49B, due to the non-uniform design of
the stent within the graft material, in some embodiments, the
prosthesis 1010 can be efficiently packed within the outer sheath
1006 so as to surround the sheaths 1024 and efficiently fill the
space within the outer sheath 1006. In this configuration, for
example, the prosthesis 1010 can be loaded within the outer sheath
1006 so that the sheaths 1024 are advanced between many of the
struts, bends, loops, and other features that the stent can
comprise, thereby permitting the sheaths 1024 sufficient space to
be loaded within the outer sheath 1006 so that the lumen of the
sheaths 1024 are not compressed or collapsed in the loaded state.
Additionally, the graft can be formed from a bi-directionally
expanded, layered PTFE material have thin walls to further increase
the space efficiency of the prosthesis 1010.
[0267] In some embodiments, as illustrated in FIG. 51, where used,
the peelable sheath 1060 can have one or more release wires 1062
(two being shown) advanced through openings or perforations 1064
formed in the sheath 1060 along two sides of the sheath 1060. The
release wires 1062 can be configured to tear the sheath 1060 along
two lines of perforations 1064 and/or scores formed along two sides
of the sheath 1060, so that the sheath 1060 can be removed from the
prosthesis 1010 while the sheaths 1024 are advanced through the
fenestrations 1011, 1061, respectively, in the prosthesis 1010 and
sheath 1060. In this configuration, each of the two release wires
1062 can be secured to a proximal end portion 1060a of the sheath
1060, so that both halves of the sheath 1060 can be retracted
through the outer sheath 1006.
[0268] However, as illustrated in FIG. 52, some embodiments of the
catheter system 1000 can be configured to only have one release
wire 1062 threadedly advanced through the sheath 1060. FIG. 52 is
an enlarged side view of the embodiment of the catheter system 1000
shown in FIG. 43, defined by curve 52-52 shown in FIG. 50, showing
the outer sheath 1006 in a partially retracted position and the
distal sheath 1012 in a partially advanced position.
[0269] In some embodiments, the perforations 1064 formed in the
sheath 1060 can be arranged along an axial line along the length of
the portion of the sheath 1060 from the fenestrations 1061 to the
distal end of the sheath 1060, and also arranged to split the
sheath 1060 between the two fenestrations 1061 formed in the sheath
1060. In some embodiments, as illustrated in FIG. 52, the
perforations 1064 formed in the sheath 1060 arranged along the
length of the sheath 1060 can be positioned to tear the sheath 1060
from one of the fenestrations 1061 to the distal end 1060b of the
sheath 1060, and also to circumferentially tear the sheath 1060
between the fenestrations 1061.
[0270] As mentioned above, with reference to FIG. 52, some
embodiments of the catheter system 1000 can be configured such that
a proximal portion 1010b of the prosthesis 1010 can be deployed by
axially advancing the inner tube 1016 relative to the inner core
1020 of the delivery catheter 1004 and, hence, the prosthesis 1010.
Some embodiments of the prosthesis 1010 can be self-expanding such
that removing the radial constraint provided by the distal sheath
1012 can cause the portion of the prosthesis 1010 constrained by
the inner tube 1016 to expand toward the vessel wall. In some
embodiments, the proximal portion 1010b of the prosthesis 1010 can
be deployed in this manner before the distal portion 1010a of the
prosthesis 1010 is deployed, or simultaneously with the deployment
of the distal portion 1010a of the prosthesis 1010. In some
embodiments, the proximal portion 1010b of the prosthesis 1010 can
be deployed in this manner after the distal portion 1010a of the
prosthesis 1010 is deployed.
[0271] FIG. 53 is a side view of the embodiment of the catheter
system 1000 shown in FIG. 43, showing the outer sheath 1006 in a
partially retracted position and the embodiment of one branch
sheath 1024' and one push catheter 1026' in a partially advanced
position. The branch sheath 1024' can be advanced relative to the
inner core 1020, the prosthesis, and the second branch sheath
1024'' by advancing a proximal portion of the branch sheath 1024'
in the direction of arrow A1 in FIG. 53 through the access port
1052' at the proximal end of the delivery catheter 1004. Similarly
(not shown), the second branch sheath 1024'' can be advanced
relative to the inner core 1020, the prosthesis, and the first
branch sheath 1024' by advancing a proximal portion of the branch
sheath 1024'' through the access port 1052'' at the proximal end of
the delivery catheter 1004. Additionally, either of the push
catheters 1026', 1026'' can be advanced relative to the branch
sheaths 1024', 1024'' by advancing the respective push catheter
1026 through the respective access port 1054. For example, the push
catheter 1026' can be advanced by advancing the proximal portion of
the push catheter 1026' in the direction of arrow A2 in FIG.
53.
[0272] With the embodiments of the catheter system 1000 having been
described, several configurations of deployment methods for an
endoluminal prosthesis, including any suitable prosthesis or any
endoluminal prosthesis disclosed herein, will now be described with
reference to FIGS. 54-61. FIG. 54 is a section view of a portion of
a patient's vasculature, showing the delivery catheter 1000 being
advanced through a patient's abdominal aorta over a guidewire 1070
positioned within a patient's vasculature. In some embodiments, as
in the illustrated embodiment, the delivery catheter 1000 can be
advanced through a prosthesis 1080 (which can be a bifurcated
prosthesis) deployed within the patient's vasculature.
[0273] FIG. 55 is a section view of a portion of a patient's
vasculature, showing the delivery catheter 1000 and an angiographic
catheter 1065 being advanced through a branch sheath 1024 of the
delivery catheter toward a target branch vessel. As illustrated, an
outer sheath 1006 of the catheter system 1000 has been retracted
relative to the inner core (not shown) and the prosthesis 1010,
exposing a middle portion of the prosthesis 1010 (i.e., a portion
of the prosthesis 1010 radially adjacent to the one or more
fenestrations 1011) and the branch sheaths 1024a, 1024b. In some
embodiments, after the branch sheaths 1024a, 1024b have been
exposed, a suitable angiographic catheter 1065 can be advanced
through the lumen of either or both of the branch sheaths 1024a,
1024b and directed into the target branch vessel or vessels. A user
can rotate the inner core 1020 to approximately rotationally align
the fenestrations 1011 of the prosthesis 1010 or the branch sheaths
1024 with the branch vessels.
[0274] In some embodiments, as discussed above, the optional sheath
1060 can constrain the mid and distal portions of the prosthesis
1010 such that, when the outer sheath 1006 is retracted, the mid
and distal portions of the prosthesis 1010 do not self-expand.
However, in some embodiments, the mid portion of the prosthesis
1010 radially adjacent to the one or more fenestrations 1011 can be
unsupported by any stents, struts, connectors or can be minimally
supported by stents or connectors 1254 (also referred to herein as
connecting members). In some embodiments of this configuration, the
prosthesis 1010 can be configured such that there is no radial
force or support provided to the mid portion of the prosthesis
1010, or such that the mid portion of the prosthesis 1010 will not
be biased to self-expand when the outer sheath 1006 is retracted.
Accordingly, some embodiments can be configured such that no
additional restraint in addition to, for example, the outer sheath
1006, is required. Therefore, in some embodiments, only the outer
sheath 1006 and the distal sheath 1012 can be used to restrain the
prosthesis 1010. In this configuration, the outer sheath 1006 can
be partially retracted to release the sheaths 1024 so that one or
more angiographic catheters 1065 can be advanced through the
sheaths 1024 and into the target branch vessels before the proximal
and distal portions of the prosthesis 1010 are released from the
deployment catheter 1004.
[0275] Some embodiments of the angiographic catheter 1065 can be
configured such that an end portion thereof is biased to have a
curved disposition. In some embodiments, this can be accomplished
by shortening the length of the wall of one side of the end portion
of the angiographic catheter 1065 as compared to the length of the
wall of the other side of the angiographic catheter 162. In some
embodiments, an end portion of the sheaths 1024 can be also be
formed so as to be biased to have a curved end portion. Some
embodiments of the sheaths 1024 can be formed in this configuration
by heat setting an end portion of the sheath in a curved
disposition, or by otherwise shortening the wall of one side of the
end portion of the catheter as compared to the other side of the
end portion of the catheter. In some embodiments, the branch
sheaths 1024 can have a curved end portion so that such sheaths
1024 can be directed into the branch arteries or vessels without
the use of an angiographic catheter.
[0276] As shown, an angiographic catheter 1065 is being advanced
relative to the branch sheath 1024a and into the target branch
vessel, in this case a renal artery. Some embodiments of the
delivery catheter 1000 can be configured such that an angiographic
catheter can be advanced through the desired branch sheath 1024 and
into the target vessel without retracting the outer sheath 1006.
After the angiographic catheters 1065 have been directed into the
target location, in this case the branch vessels, either or both of
the branch sheaths 1024 can be independently or simultaneously
advanced over the angiographic catheters 1065 into the target
branch vessels, as is illustrated in FIG. 56. In some embodiments,
the branch sheaths 1024, the fenestrations 1011, 1061 formed in
either the prosthesis 1010 or the sheath 1060, respectively, and/or
any other components or features of the delivery catheter 1000 can
have radiopaque markers or other indicators to assist a medical
practitioner in the deployment procedures described herein or other
suitable deployment procedures.
[0277] With the branch sheaths 1024 in the target vessels and the
outer sheath 1006 axially retracted, as shown in FIG. 57, a
proximal portion 1010b of the prosthesis 1010 can be deployed by
axially advancing the distal sheath 1012 relative to the inner core
1020 and the prosthesis 1010. In some embodiments, the prosthesis
1010 can be axially and rotationally secured to the outer tube
1018, which can be axially and rotationally secured to the inner
core 1020, such that advancing the distal sheath 1012 relative to
the inner core 1020 will advance the distal sheath 1012 relative to
the prosthesis 1010. As described above, the distal sheath 1012 can
be advanced relative to the inner core 1020 and the prosthesis 1010
by advancing the inner tube 1016 relative to the inner core 1020,
the inner tube 1016 being axially engaged with the distal tip 1014
which can support the distal sheath 1012.
[0278] FIG. 58 is a section view of a portion of a patient's
vasculature, showing an embodiment of a peelable sheath 1060 being
removed from the distal portion 1010a of the prosthesis 1010 so as
to deploy a distal portion 1010a of the prosthesis 1010. Some
embodiments of the sheath 1060 can be removed by axially retracting
a release wire 1062, which can be looped or other otherwise
threaded through openings or perforations 1064 formed in the sheath
material. The release wire 1062 can be configured to tear through
the sheath material between the perforations 1064, thereby
permitting the self-expanding prosthesis 1010 to expand toward the
vessel walls. As mentioned, some embodiments of the prosthesis 1010
can be configured to be restrained within the outer sheath 1006 and
the distal sheath 1012 such that an additional restraint, such as
the peelable sheath 1060, is not required.
[0279] In some embodiments, as illustrated, a distal portion 1060a
of the sheath 1060 can be torn by the release wire 1062 before a
proximal portion 1060b of the sheath 1060 is torn by the release
wire so that a proximal portion 1010a of the prosthesis (i.e.,
adjacent to the proximal portion 1060a of the sheath 1060) can be
deployed before a distal portion 1010b of the sheath 1010. In some
embodiments (not illustrated), a proximal portion 1060b or a middle
portion of the sheath 1060 can be torn by the release wire 1062
before a distal portion 1060a of the sheath 1060 is torn by the
release wire. In some embodiments, the release wire 1062 can be
secured to the proximal portion 1060b or other suitable portion of
the sheath 1060 such that, after the sheath 1060 has been torn, the
sheath 1060 can be removed through the delivery catheter 1000 by
continuing to axially retract the release wire 1062 relative to the
prosthesis 1010.
[0280] As illustrated, a distal portion 1010b of the prosthesis
1010 (i.e., the downstream portion of the prosthesis 1010) can be
deployed within an opening of an adjacent prosthesis, such as
without limitation the bifurcated prosthesis 1080 illustrated in
FIG. 58. However, in some embodiments, the delivery catheter 1000
or any other delivery catheter described herein can be used to
deploy any suitable prosthesis, including a bifurcated prosthesis
or otherwise, in any portion of a patient's vasculature. As such,
in some embodiments, the prosthesis 1000 can be a bifurcated
prosthesis.
[0281] FIG. 59 is a section view of a portion of a patient's
vasculature, showing an embodiment of a push catheter 1026
advancing an inner wall of the prosthesis 1010 adjacent to a
fenestration 1011 toward an ostium of the target branch vessel. As
illustrated, the push catheter 1026 can be advanced through a lumen
in the inner core 1020 to push the fenestration 1011 of the
prosthesis 1010 over the branch sheath 1024 and into approximate
alignment with the ostium of the branch vessel. In some
embodiments, the catheter system 1000 can be configured to not have
a push catheter 1026, and can accordingly be configured to deploy a
fenestrated graft without the use of such a component. As will be
described below, in some embodiments, snares, protrusions, tabs, or
other features can be formed on the sheaths 1024 to push the
fenestrations toward the branch vessel ostium.
[0282] In some embodiments, as illustrated in FIG. 60, a covered or
uncovered branch stent 1084 can be deployed in the branch vessel by
advancing the branch stent 1084 through the branch sheath 1024
using a suitable catheter, such as a renal stent catheter, into the
target vessel, after the angiographic catheter has been removed
from the branch sheath 1024. The stent 1084 can be supported on an
inflation balloon 1086, which can be supported by a guidewire 1088.
The guidewire 1088 can be configured to have an inflation lumen
therein, to inflate the balloon 1086 and expand the branch stent
1084 in the target location after the branch sheath 1024 has been
at least partially retracted so as to not interfere with the
expansion of the branch stent 1084, as illustrated in FIG. 61. In
some embodiments, the inflation balloon 1086 can be configured to
expand and flare a portion of the stent 1084 within or to the
inside of the fenestration 1011 formed in the prosthesis.
[0283] Some embodiments of the push catheter 1026 described above
can be configured to be supported within a renal or branch stent
delivery catheter. For example, without limitation, the push
catheter 1026 can be configured to be supported within a modified
embodiment of a renal stent catheter, such as the renal stent
catheter illustrated in FIG. 60. In some embodiments, the push
catheter 1026 can be configured to only partially surround the
branch sheath 1024 or the branch stent delivery catheter. In this
configuration, the push catheter 1026 can be configured to be
entirely positioned within and advanceable through a lumen of the
branch sheath 1024 or the branch stent delivery catheter. For
example, the push catheter 1026 can have an expandable end portion
that can automatically expand when the end portion is advanced past
the end of the lumen, so as to enable the end portion to snare or
engage the graft material surrounding the fenestration.
[0284] Additionally, in some embodiments, the branch stent delivery
catheter can be configured to have a snare, protrusion, or other
object tethered to the balloon or stent, or to be projecting from
an outside surface thereof to snare or engage the graft material
adjacent to the fenestration, so as to cause the fenestration to be
advanced toward the ostium as the branch stent delivery catheter is
advanced through the fenestrations. For example, without
limitation, the branch stent delivery catheter can have a biased
wire member supported on an outside surface of the branch stent
delivery catheter that is biased to expand when the wire member is
advanced past the end of the branch sheath 1024. The wire member
can expand to a size that is larger than the size of the
fenestration. The wire member can be supported at a position that
is offset from an end of the branch stent delivery catheter.
[0285] In some embodiments, the fenestration 1011 in the prosthesis
1010 can be expanded as the branch stent 1084 is being expanded, to
improve the seal between the fenestration 1011 and the branch stent
1084. In some embodiments, a second expansion balloon can be
positioned in the portion of the stent 1084 within or to the inside
of the fenestration 1011 to flare that portion of the stent 1084,
either with or without removing the first balloon used to expand
the main portion of the branch stent 1084.
[0286] Some arrangements are directed to methods of deploying an
endoluminal prosthesis, such as without limitation the prosthesis
1010 described above, comprising inserting a delivery catheter such
as catheter system 1000 into an artery, exposing one or more branch
sheaths 1024, advancing one or more angiographic catheters with one
or more guidewires into the one or more branch sheaths 1024 and
cannulating the target branch vessels, advancing the one or more
branch sheaths 1024 over the angiographic catheters and into the
target branch vessels, deploying a proximal portion of the
prosthesis, deploying a distal portion of the prosthesis, removing
the one or more angiographic catheters and/or the guidewires,
inserting one or more branch stents into the branch vessels,
retracting the branch sheaths, expanding the branch stents, and
flaring a portion of the branch stents. The steps of the foregoing
procedure can be performed in the sequence described, or can be
performed in any suitable sequence. In some arrangements, the
target branch vessels are the renal arteries. The step of deploying
a distal portion of the prosthesis can be performed in some
arrangements by tearing and retracting a peelable sheath member, or
by retracting a tubular sheath such as an outer sheath. Deploying a
proximal portion of the prosthesis can be performed in some
arrangements by distally advancing a tubular sheath.
[0287] Some arrangements are directed to methods of deploying an
endoluminal prosthesis, such as without limitation the prosthesis
1010 described above, comprising inserting a delivery catheter such
as catheter system 1000 into an artery, exposing one or more branch
sheaths 1024, advancing one or more angiographic catheters having
one or more guidewires into the one or more branch sheaths 1024 and
cannulating the target branch vessels, advancing the one or more
branch sheaths 1024 over the angiographic catheters and into the
target branch vessels, removing the one or more angiographic
catheters and/or guidewires, inserting one or more branch stents
into the branch vessels, retracting the branch sheaths, expanding
the branch stents, and flaring a portion of the branch stents. The
target branch vessels can be the renal arteries. The steps of the
foregoing procedure can be performed in the sequence described, or
can be performed in any suitable sequence.
[0288] Some arrangements are directed to methods of deploying an
endoluminal prosthesis, such as without limitation the prosthesis
1010 described above, comprising inserting a delivery catheter such
as catheter system 1000 into an artery, exposing one or more branch
sheaths 1024, advancing one or more angiographic catheters having
one or more guidewires into the one or more branch sheaths 1024 and
cannulating the target branch vessels, advancing the one or more
branch sheaths 1024 over the angiographic catheters and into the
target branch vessels, deploying a prosthesis, removing the one or
more angiographic catheters and/or guidewires, inserting one or
more branch stents into the branch vessels, retracting the branch
sheaths, expanding the branch stents, and flaring a portion of the
branch stents. In some arrangements, the target branch vessels are
the renal arteries. The steps of the foregoing procedure can be
performed in the sequence described, or can be performed in any
suitable sequence.
[0289] Some arrangements are directed to methods of deploying an
endoluminal prosthesis, such as without limitation the prosthesis
1010 described above, comprising inserting a delivery catheter such
as catheter system 1000 into an artery, exposing one or more branch
sheaths 1024, advancing one or more angiographic catheters having
one or more guidewires into the one or more branch sheaths 1024 and
cannulating the target branch vessels, advancing the one or more
branch sheaths 1024 over the angiographic catheters and into the
target branch vessels, advancing the wall of the prosthesis
adjacent to each of one or more fenestrations in the prosthesis
toward the ostium of the target branch vessels, removing the one or
more angiographic catheters and/or guidewires, inserting one or
more branch stents into the branch vessels, retracting the branch
sheaths, expanding the branch stents, and flaring a portion of the
branch stents. In some arrangements, the target branch vessels are
the renal arteries. Some arrangements also comprise deploying a
proximal and distal portion of the prosthesis. The steps of the
foregoing procedure can be performed in the sequence described, or
can be performed in any suitable sequence.
[0290] Some arrangements are directed to methods of deploying an
endoluminal prosthesis, such as without limitation the prosthesis
1010 described above, comprising inserting a delivery catheter such
as catheter system 1000 into an artery, exposing one or more branch
sheaths 1024, advancing one or more angiographic catheters having
one or more guidewires into the one or more branch sheaths 1024 and
cannulating the target branch vessels, advancing the one or more
branch sheaths 1024 over the angiographic catheters and into the
target branch vessels, deploying a proximal portion of the
prosthesis, advancing the wall of the prosthesis adjacent to each
of one or more fenestrations in the prosthesis toward the ostium of
the target branch vessels, removing the one or more angiographic
catheters and/or guidewires, inserting one or more branch stents
into the branch vessels, retracting the branch sheaths, expanding
the branch stents, and flaring a portion of the branch stents. In
some arrangements, the target branch vessels are the renal
arteries. Some arrangements also comprise deploying a proximal and
distal portion of the prosthesis. The steps of the foregoing
procedure can be performed in the sequence described, or can be
performed in any suitable sequence.
[0291] Some arrangements are directed to methods of deploying an
endoluminal prosthesis, such as without limitation the prosthesis
1010 described above, comprising advancing a delivery catheter such
as catheter system 1000 into a blood vessel or artery, exposing one
or more branch sheaths 1024, advancing one or more angiographic
catheters into the one or more branch sheaths 1024 and cannulating
the target branch vessels, and advancing the one or more branch
sheaths 1024 over the angiographic catheters and into the target
branch vessels. The steps of the foregoing procedure can be
performed in the sequence described, or can be performed in any
suitable sequence. In some embodiments, the step of advancing the
one or more angiographic catheters into the one or more branch
sheaths 1024 and cannulating the target branch vessels can be
completed before expanding a main body portion of the prosthesis.
In some embodiments, the one or more angiographic catheters can
have one or more guidewires therein.
[0292] Some arrangements are directed to methods of deploying a
stent graft across at least one branch vessel, the stent graft
having at least one lateral opening or fenestration formed therein
and the stent graft being constrained within a delivery system
having a distal and a proximal end, wherein a catheter extends from
the proximal end of the delivery system through the fenestration
formed in the stent graft. In some arrangements, a guidewire can be
passed from the proximal end of the delivery system through the
catheter and into the target branch vessel with the proximal and
distal end of the stent graft remaining constrained in the delivery
system.
[0293] Some embodiments are directed to apparatuses for placing a
prosthesis across at least one branch vessel, the prosthesis having
a distal end, a proximal end, a midsection, and at least one
lateral opening in the midsection of the prosthesis. In some
embodiments, the prosthesis can be constrained in a delivery system
having a distal and a proximal end. The apparatus can comprise a
catheter extending from the proximal end of the delivery system
through the lateral opening in the prosthesis, wherein a guidewire
can be passed from the proximal end of the delivery system through
the catheter, into the branch vessel with at least the proximal and
distal ends of the prosthesis remaining constrained in the delivery
system. In some embodiments, the prosthesis can be a stent
graft.
[0294] FIGS. 62A and 62B are perspective views of an embodiment of
a prosthesis 1200 comprising one or more fenestrations 1202 formed
in the graft 1204, and a stent or support member 1206. The
embodiment of the graft 1204 is shown in dashed lines in FIG. 62B
for clarity. In some embodiments, the prosthesis 1200 can have any
of the features, components, or other details of any other
prosthesis embodiments disclosed herein such as, without
limitation, prosthesis 1010 described above. Further, any of the
features of the embodiment of the prosthesis 1200 can be used in
combination with any of the other prosthesis embodiments disclosed
herein.
[0295] In some embodiments, the graft 1204 can be supported by the
stent 1206 along at least a portion of the graft 1204. Further, the
graft 1204 can be overlapped and can have stitching or sutures 1208
along one or more edges of the graft 1204, which can improve the
tear resistance of the graft 1204 and can improve the connection
between the graft 1204 and the stent 1206.
[0296] Similar to other graft embodiments described herein, some
embodiments of the graft 1204 can be configured to have excess or
slack graft material in at least a portion thereof relative to the
stent which supports the graft. For example, without limitation,
the excess graft material can faun a bulge or other enlargement in
the graft 1204 in the approximate location of one or more
fenestrations 1202 formed through the graft material. The excess or
slack material along the circumference of the graft 1204 (for
example, without limitation, in the enlarged portion 1204a of the
graft 1204) can allow for circumferential and/or axial movement of
the graft material and, hence, the one or more fenestrations 1202,
relative to the stent 1206 and the ostium of the patient's branch
vessels. Therefore, in some embodiments, the diameter of the graft
1204 at and/or adjacent to the location of one or more
fenestrations 1202 can be larger than the local diameter of the
target vessel. Similarly, in some embodiments, the diameter of the
graft 1204 at and/or adjacent to the location of one or more
fenestrations 1202 can be larger than the diameter of the
non-enlarged portion of the graft material. In some embodiments,
without limitation, the outside surface of the graft 1204 in the
enlarged portion 1204a or otherwise can be free from any
corrugations or other preformed folds, overlaps, or other similar
pre-formed features.
[0297] Further, similar to any of the other graft embodiments
disclosed herein, the graft 1204 can have excess graft material in
an axial direction, in addition to or in the alternative of the
diametrically enlarged portion. The excess or slack material along
the length of the graft 1204 can increase the circumferential
and/or axial adjustability or movement of the graft material
adjacent to the one or more fenestrations 1202 formed in the graft
1204. Accordingly, in some embodiments, the length of the graft
material between the proximal and distal attachment points to the
stent 1206 can be longer than that of the stent 1206 between the
proximal and distal attachment points. Or, in some embodiments, the
graft material in a mid portion of the graft 1204, including on
either side of the enlarged portion 1204a, can have an increased
length relative to the stent radially adjacent to such graft
portion.
[0298] Further, in some embodiments, the enlarged portion and/or
excess length of the graft 1204 or any other graft embodiment
disclosed herein can be free from any attachment points to the
stent or support member which supports the graft 1204. In these
configurations, the positional adjustability of the `fenestrations
can be increased because the graft material is free to move in an
axial and/or circumferential direction relative to the stent and
relative to the ostium of the target branch vessels. In some
embodiments, the enlarged portion and/or excess length of the graft
1204 or any other graft embodiment disclosed herein can be
configured to have only a limited number of attachment points to
the stent or support member which supports the graft 1204. The
attachment points can be sufficiently away from the fenestration or
opening so as to not substantially affect the adjustability of the
fenestration. For example, without limitation, some embodiments of
the prosthesis 1010 can be configured such that the enlarged or
slack portion of the graft has only a limited number of attachments
to a stent or connector (such as connector 1254) away from the
fenestrations 1202 so that the adjustability of the enlarged or
slack portion is not significantly affected. For example, in
embodiments having only one fenestration in the enlarged portion,
the attachment or attachments to the stent or other support member
can be positioned on an opposite side of the graft as compared to
the position of the fenestration. In these configurations, the
positional adjustability of the fenestrations can be increased
because the graft material is substantially free to move in an
axial and/or circumferential direction relative to the stent and
relative to the ostium of the target branch vessels.
[0299] With reference to FIGS. 62A-63, some embodiments of the
graft 1204 can have one or more enlarged portions 1204a having an
enlarged diameter relative to the target vessel or relative to one
or more non-enlarged portions of the graft 1204, such as portions
1204b, 1204c that can improve the radial and/or axial adjustability
of the fenestrations 1202 formed in the enlarged portions 1204a to
better accommodate asymmetrically positioned branch vessel ostium.
In some embodiments, with reference to FIGS. 62A and 62B, the graft
1204 can have an enlarged middle portion 1204a having one or more
fenestrations 1202 formed therein, a non-enlarged proximal portion
1204b, and a non-enlarged distal portion 1204c.
[0300] As discussed above, in some embodiments of the prosthesis
1200, the enlarged portion 1204a of the graft 1204 can have a
diameter that is approximately 30% larger than a diameter of the
target vessel or the diameter of the non-enlarged portions 1204b,
1204c of the graft 1204. In some embodiments, the diameter of the
enlarged portion 1204a of the graft 1204 can be from approximately
20% or less to approximately 50% or more, or from approximately 25%
to approximately 40% larger than the target vessel or the diameter
of the non-enlarged portions 1204b, 1204c of the graft 1204, or to
or from any values within these ranges.
[0301] Additionally, in some embodiments, the enlarged portion
1204a or portion of the graft 1204 adjacent to the enlarged portion
1204a of the graft 1204 can be sized and configured to be
substantially longer (i.e., in the axial direction) than the stent
1206, which can improve the radial and/or axial adjustability of
the fenestrations 1202 formed in the enlarged portions 1204a to
better accommodate the asymmetric and/or non-uniform positioning of
branch vessel ostium. Some embodiments of the graft 1204 can be
longer than the stent 1206 in both the enlarged portion 1204a of
the graft 1204 and/or in the portion of the non-enlarged distal
portion 1204c of the graft adjacent to the enlarged portion 1204a
of the graft 1204. For example, without limitation, the enlarged
portion 1204a or portion of the graft 1204 adjacent to the enlarged
portion 1204a of the graft 1204 can be sized and configured to be
approximately 20% longer in the axial direction than the stent
1206. In some embodiments, the enlarged portion 1204a or portion of
the graft 1204 adjacent to the enlarged portion 1204a of the graft
1204 can be sized and configured to be from approximately 10% to
approximately 40% or more longer in the axial direction than the
stent 1206.
[0302] FIG. 63 is a top view of the embodiment of the prosthesis
1200 of FIG. 62. With reference to FIGS. 62-63, some embodiments of
the prosthesis 1200 can have fenestrations 1202 formed in an
enlarged portion 1204a of the graft 1204. In some embodiments, the
fenestrations 1202 can be formed at non-diametrically opposed
positions. This can improve the alignment of the fenestrations 1202
with the ostium of the target branch vessels, which in general can
be located at non-diametrically opposed positions. In some
embodiments, the fenestrations 1202 formed in either the enlarged
portion or portions 1204a or non-enlarged portions 1204b, 1204c of
the graft 1204, can be angled away from the diametrically opposed
position (represented by angle X in FIG. 63) such that the
fenestrations 1202 are separated by an angle (represented by angle
Y in FIG. 63) that is less than 180 degrees.
[0303] For example, without limitation, some embodiments of the
graft 1204 can have two fenestrations 1202 formed at an angle away
from the diametrically opposed position (represented by angle X in
FIG. 63) of approximately 15 degrees such that the fenestrations
1202 are separated by an angle (represented by angle Y in FIG. 63)
that is approximately 150 degrees. Some embodiments of the graft
1204 can have two fenestrations 1202 formed at an angle away from
the diametrically opposed position of between approximately 10
degrees or less and approximately 20 degrees or more, such that the
fenestrations 1202 are separated by an angle (represented by angle
Y in FIG. 63) that is between approximately 160 degrees and
approximately 140 degrees.
[0304] Some embodiments of the graft 1204 can have two
fenestrations 1202 formed in an enlarged portion 1204a of the graft
and wherein the fenestrations 1202 are separated by an angle that
is less than 180 degrees, for example approximately 150 degrees. In
this configuration, positioning the fenestrations 1202 to be
separated by an angle that is less than 180 degrees (such as, for
example, approximately 150 degrees) can improve the alignment of
the fenestrations 1202 with the ostium of the target branch vessels
such that the enlarged portion 1204a of the graft 1204 can be from
approximately 20% to approximately 60% greater than the
non-enlarged portion 1204b, 1204c of the graft 1204. In some
embodiments of this configuration, the enlarged portion 1204a of
the graft 1204 can be from approximately 20% to approximately 40%
greater than the non-enlarged portion 1204b, 1204c of the graft
1204.
[0305] Some embodiments of the graft 1204, which can be a
bifurcated or other suitably configured graft, can have two
fenestrations 1202 formed in an enlarged portion 1204a of the
graft, wherein the fenestrations 1202 can be separated by an angle
that is less than 180 degrees, and wherein the length of at least a
portion of the graft 1204 can be substantially greater than the
length of the stent 1206, for example approximately 10% greater
than the length of the stent 1206. In this configuration,
positioning the fenestrations 1202 to be separated by an angle that
is less than 180 degrees (such as, for example, approximately 150
degrees) and increasing the length of the graft 1204 to be
approximately 10% greater than the length of the stent 1206 can
improve the alignment/alignability of the fenestrations 1202 with
the ostium of the target branch vessels such that the enlarged
portion 1204a of the graft 1204 can be from approximately 10% or
less to approximately 20% greater than the non-enlarged portion
1204b, 1204c of the graft 1204.
[0306] With reference to FIGS. 62-63, though not required, some
embodiments of the prosthesis 1200 can have reinforced
fenestrations 1202 comprising a tubular member 1210 inserted
through the fenestration 1202 and stitched to the graft 1204 with
one or more sutures 1212. In this configuration, which will be
described in greater detail below, the tubular member 1210 can
improve the tear resistance of the fenestration 1202 and also
improve the sealability between the fenestrations 1202 and the
branch grafts and stents deployed within the fenestrations 1202 as
well as the pull-out resistance of the branch grafts and stents
within the fenestrations 1202. This configuration can reduce
leakage between the fenestrations 1202 and the branch grafts and
stents deployed within the fenestrations 1202. In some embodiments,
this configuration can also increase the force required to pull the
branch grafts and stents deployed within the fenestrations 1202 out
of the fenestrations 1202, thereby reducing the inadvertent axial
movement of the branch grafts and stents deployed within the
fenestrations 1202.
[0307] With reference to FIGS. 65-68, some embodiments of the
fenestration 1202 and some arrangements of methods for
manufacturing the fenestrations 1202 will be described. FIG. 65 is
a partially exploded schematic representation of the prosthesis
1200 shown in FIG. 62, and FIG. 66 is an enlargement of the
fenestration 1202 shown in FIG. 65, defined by curve 66-66 of FIG.
65. As shown therein, in some embodiments, the tubular member 1210
can be contracted and advanced into the openings 1220 formed in the
graft 1204. In some embodiments, the diameter of the tubular member
1210 can be significantly greater than the diameter of the opening
1220. For example, without limitation, the diameter of the tubular
member 1210 can be approximately 500 percent of the diameter of the
opening 1220, or from approximately 200 percent to approximately
800 percent of the diameter of the opening 1220, from approximately
400 percent to approximately 600 percent of the diameter of the
opening 1220, or to or from any values within these ranges. In some
embodiments, the diameter of the tubular member 1210 can be
approximately 10 mm, and the diameter of the opening 1220 can be
approximately 2 mm.
[0308] In some embodiments, the length of the tubular member 1210
can be greater than the diameter of the tubular member 1210 or the
diameter of the fenestration 1202. In some embodiments, the length
of the tubular member 1210 can be from approximately 5 mm or less
to approximately 25 mm or more, or from approximately 10 mm to
approximately 15 mm, or to or from any values within these
ranges.
[0309] FIG. 67 is an enlarged section view of the fenestration 1202
illustrated in FIG. 65, showing the end portions 1210a of the
tubular member 1210 being pulled back against the wall of the graft
1204 surrounding the opening 1220. As illustrated therein, an
annular radiopaque marker 1222 can be positioned around the outside
surface of the tubular member 1210, so that such marker 1222 is
secured within the annular space created by folding or stretching
the end portions 1210a of the tubular member 1210 against the wall
of the graft 1204. As illustrated in FIG. 68, the end portions
1210a of the tubular member 1210 can thereafter be fixed to the
wall of the graft 1204 using adhesive, sutures, or any other
suitable fasteners, material, or technique.
[0310] In this configuration, in some embodiments, the length of
the seal zone or contact length of the fenestration 1202 in the
relaxed state (represented by length L in FIG. 68), before a branch
stent or graft is deployed within the fenestration 1202, can be
significantly greater than a contact length of a conventional
fenestration not having a tubular member therein. In some
embodiments, the contact length L of the fenestration 1202 in the
relaxed state can be approximately the same as the diameter of the
fenestration 1202 in the unstretched state. In some embodiments,
the contact length L of the fenestration 1202 in the relaxed state
can be from approximately 50 percent or less to approximately 150
percent of the diameter of the fenestration 1202 in the unstretched
state, or from approximately 80 percent or less to approximately
120 percent of the diameter of the fenestration 1202 in the
unstretched state.
[0311] With reference to FIGS. 62A and 62B, although not required,
some embodiments of the graft 1204 can have a scallop or cut-away
1230 at a proximal end portion 1204b of the graft 1204. The
cut-away 1230 can be sized and configured to permit unrestricted
blood flow through a branch artery, such as the suprarenal and/or
the celiac arteries. The size of the cut-away 1230 can be based on
the anatomy of a patient, or can be sized to accommodate a wide
range of vessel anatomies. In some embodiments, the cut-away 1230
can have a length approximately equal to the length of two stent
struts, such as stent strut 1246 described below. The graft 1204
can be overlapped and have stitching 1208 along an edge of the
cut-away 1230. In some embodiments, the prosthesis 1200 can have a
flared proximal end portion to increase the sealability of such end
portion of the prosthesis 1200.
[0312] In some embodiments, as described above, the prosthesis 1200
can have one or more radiopaque markers, such as but not limited to
the annular radiopaque marker 1222 surrounding at least a portion
of the fenestration 1202, for improved visibility under fluoroscopy
during deployment. In some embodiments, any of the radiopaque
markers can be formed from gold or platinum, or any suitable
material. In some embodiments, any of the radiopaque markers can be
formed from a suitable non-reinforcing metallic material.
[0313] FIG. 69 is a side view of the embodiment of the stent 1206
shown in FIG. 62, viewed along a line that is perpendicular to an
axis projecting through a fenestration formed in the graft 1204
(not shown). For clarity, the location of a fenestration 1202 is
shown dashed lines. FIG. 70 is a side view of the stent 1206,
viewed along an axis projecting through a fenestration. Again, for
clarity, the location of a fenestration 1202 is shown dashed
lines.
[0314] With reference to FIGS. 64 and 69-70, in some embodiments,
the stent 1206 can be formed from one or more wires forming a
plurality of loops 1240, which can be closed loops or eyelets,
bends 1242, and struts 1246. Some of the bends 1242 can be
configured to slide along a portion of the length of a respective
strut 1246, to improve the flexibility and bendability of the stent
1206. In some embodiments, the positioning of the plurality of
loops 1240 and bends 1242 can be longitudinally offset or staggered
to decrease the collapsed diameter of the prosthesis 1200.
[0315] In some embodiments, the stent 1206 can comprise, a first
stent segment 1250 formed from one or more lengths of wire, a
second stent segment 1252 formed from one or more lengths of wire,
and one or more connecting members 1254 formed from one or more
lengths of wire. In some embodiments, the first and second stent
segments 1250, 1252 can be positioned proximally and distally
relative to the location of the fenestration (shown in dashed
lines) that can be formed in the graft (not illustrated) that can
be supported by the stent 1206. The length of the first stent
segment 1250 can be sufficient to result in an increased seal zone
in the suprarenal portion of the aorta, such as a length that
extends to a position adjacent to or overlapping the superior
mesenteric artery and/or the celiac artery.
[0316] In some embodiments, two connecting members 1254 can be
positioned between the first and second stent segments 1250, 1252,
and can be sized and offset from one another to provide a
significant gap around the position of the fenestrations 1202 to
increase the accessibility and adjustability of the fenestrations
1202 during deployment of the prosthesis 1200. As illustrated, some
embodiments of the connecting members 1254 can have four struts.
Some embodiments of the connecting members 1254 can have three or
less struts, or can have five or more struts. Some embodiments of
the connecting members 1254 can have a first connecting member 1254
having fewer struts than a second connecting member 1254.
[0317] FIGS. 71-83 are side views of additional embodiments of
prostheses 1200 having one or more enlarged portions 1204b in the
grafts 1204 thereof, and one or more fenestrations 1202 formed in
the enlarged portions 1204b. In any of the embodiments shown in
FIGS. 71-83, the graft 1204 can have one or more enlarged portions
1204b having any of the shapes or combination of shapes illustrated
in FIGS. 71-83. Additionally, any of the graft embodiments shown in
FIGS. 71-83 can also have excess length or slack relative to the
stent 1206 along any suitable portion of the graft 1204, such as
without limitation in, above, and/or below the enlarged portions
1204b.
[0318] With reference to FIG. 71, the embodiment of the graft 1204
can define a curved or arcuately shaped enlarged portion 1204b,
having a pair of diametrically opposed fenestrations 1202 formed
therein. The embodiment of the graft 1204 shown in FIG. 72 can
define an enlarged portion 1204b having a generally flat outer
surface 1204d between two generally horizontally oriented surfaces
1204e. One or more fenestrations 1202 can be formed through the
wall of the graft 1204 in the enlarged portion 1204b. The
embodiment of the graft 1204 shown in FIG. 73 can define an
enlarged portion 1204b having a generally flat outer surface 1204d
between two angled or tapered surfaces 1204e. One or more
fenestrations 1202 can be formed through the wall of the graft 1204
in the enlarged portion 1204b.
[0319] The embodiment of the graft 1204 shown in FIG. 74 can define
an enlarged portion 1204b having two angled or tapered surfaces
1204e and one or more fenestrations 1202 formed at the approximate
juncture of the angled surfaces 1204e. The juncture of the angled
surfaces 1204e can otherwise form a pointed or smoothly curved
surface. Any of the embodiments of the prostheses 1200 illustrated
in FIGS. 71-74 can, but are not required to, have a scallop or
cut-away 1230 at a proximal end portion 1204b of the graft
1204.
[0320] Additionally, FIGS. 75-85 illustrate some non-limiting
examples of stent configurations suitable for any of the
embodiments of the prostheses disclosed herein. For example, with
reference to FIG. 75, in some embodiments, a first stent 1206a can
be supported within a proximal portion 1204b of the graft 1204,
i.e., above the enlarged portion 1204b. Similarly, a second stent
1206b can be supported within a distal portion 1204c of some
embodiments of the graft 1204, i.e., below the enlarged portion
1204b. In some embodiments, as in the embodiment illustrated in
FIG. 75, the first and second stents 1206a, 1206b can be fixed to
the graft 1204 without having any stents, connectors, struts, or
other support structures therebetween. In this configuration, the
enlarged portion 1204a can be free of any attachments points to the
stent 1206.
[0321] As illustrated in FIG. 76, in some embodiments, a first
stent 1206a and a second stent 1206b can be supported within a
proximal portion 1204b of the graft 1204, i.e., above the enlarged
portion 1204b. Similarly, a third stent 1206c and a fourth stent
1206d can be supported within a distal portion 1204c of some
embodiments of the graft 1204, i.e., below the enlarged portion
1204b. In some embodiments, as in the embodiment illustrated in
FIG. 76, the first and second stents 1206a, 1206b can be fixed to
the graft 1204 without having any stents, connectors, struts, or
other support structures therebetween. However, in some
embodiments, as illustrated in FIG. 77, the first and second stents
1206a, 1206b can have one or more connectors 1254 therebetween.
Similarly, in some embodiments, as illustrated in FIG. 76, the
third and fourth stents 1206c, 1206d can be fixed to a distal
portion 1204c of the graft 1204 without having any stents,
connectors, struts, or other support structures therebetween.
However, in some embodiments, as illustrated in FIG. 77, the third
and fourth stents 1206c, 1206d can have one or more connectors 1254
therebetween. Similar to the prosthesis embodiment illustrated in
FIG. 76, the enlarged portion 1204a of the graft 1204 can be free
from any attachment points to the stent 1206.
[0322] The embodiment of the prosthesis 1200 illustrated in FIG. 78
can have one or more struts or connectors 1254 attached to one or
more apices of the first and second struts 1206a, 1206b. In some
embodiments, the connectors 1254 can be straight struts spanning
the enlarged portion 1204a. For example, without limitation, the
prosthesis 1200 illustrated in FIG. 78 can have four total struts
1254 interconnecting the first and second stents 1206a, 1206b, as
illustrated. Some embodiments of the prosthesis 1200, such as the
embodiment of the prosthesis 1200 illustrated in FIG. 79, can have
eight total struts 1254 interconnecting the first and second stents
1206a, 1206b, as illustrated, or any suitable number of struts
1254. The prostheses 1200 illustrated in FIGS. 78 and 79 can be
configured such that the graft material in the enlarged portion
1204a is free from any attachment to the stents 1206 or the
connectors 1254.
[0323] In some embodiments, the connectors or struts 1254 can be
generally straight, as illustrated in FIGS. 78-79. However, in some
embodiments, the struts 1254 can have one or more bends 1256
therein. The bends 1256 can decrease the stiffness of the struts
1254 so that the struts 1254 are more flexible in both the axial
direction and also when the prosthesis 1200 is bent.
[0324] In some arrangements, the end portions of the connectors
1254 can be fixed to the apices of adjacent stents 1206, or can be
slidingly supported by the struts of the stents 1206. Further, in
some embodiments, the end portions of the connectors 1254 can be
supported at offset apex positions, as illustrated in FIG. 80.
Additionally, as mentioned, any of the embodiments disclosed herein
can be configured such that the enlarged portion 1204a can be free
of any attachments points to the stent 1206, or such that the
enlarged portion 1204a has a minimal number of attachments points
to the stent 1206.
[0325] With reference to FIGS. 81-83, which are side views of
several additional embodiments of prostheses 1200, one or more of
the prostheses 1200 can have asymmetrically positioned enlarged
portions 1204a' formed in the grafts 1204 thereof. Such
configurations may be suitable for, for example and without
limitation, the thoracic artery. With reference to FIG. 81, the
embodiment of the prosthesis 1200 illustrated therein can have a
first asymmetric enlarged portion 1204a' and a second asymmetric
enlarged portion 1204a'' formed therein. Some embodiments of the
prostheses disclosed herein can have a third asymmetric enlarged
portion 1204a''' faulted therein (not illustrated), or any number
or combination of symmetrical and asymmetric enlarged portions
formed therein.
[0326] In some embodiments, the prosthesis 1200 illustrated in FIG.
81 can have a first stent 1206a positioned at a first end portion
of the graft 1204, a second stent 1206b positioned at a second end
portion of the graft 1204, and a third stent 1206c positioned
between the asymmetric enlarged portions 1204a', 1204a''. However,
in some embodiments, as illustrated in FIG. 82, the graft material
can be radially unsupported between the first and second asymmetric
enlarged portions 1204a', 1204a'', and also in the asymmetric
enlarged portions 1204a', 1204a''. As illustrated in FIG. 83, first
and second asymmetric enlarged portions 1204a', 1204a'' can be
formed at any desired axial and/or circumferential position on the
graft 1204. Any of the embodiments disclosed herein can have one or
more connectors 1254 between any of the stents or stent
segments.
[0327] With reference to FIGS. 84-85, some embodiments of the
prostheses 1200 or any prostheses disclosed herein can have end
portions configured for anastomotic connection with one or more
blood vessels of a patient's body. As illustrated, the embodiments
of the prostheses 1200 illustrated in FIGS. 84 and 85 can have any
number and/or combination of symmetric or asymmetric enlarged
regions 1204a, and any suitable number or configuration of stents
1206 within the grafts 1204. Further, the anastomotic end portions
1260 can be supported by the graft 1204 and can have any suitable
size or shape for the desired anastomosis.
[0328] In some embodiments, the anastomotic end portion 1260 can be
made from ePTFE graft material or woven or knitted graft material.
The length of the anastomtoic end portions 1260 can be more than 2
cm long and as long as 20 cm to allow trimming of the end portions
by the physician to accommodate the specific anatomy of the
patient. In this configuration, the prostheses 1200 can be suitable
for hybrid procedures in which one end of the prosthesis (for
example, the anastomotic end portion 1260) is sewn surgically to
the blood vessel and the other end is secured by a stent inside the
lumen of the blood vessel.
[0329] Some embodiments of the graft 1204 and/or the tubular
members 1210, or any other graft embodiments disclosed herein, can
be formed from a bi-directionally expanded, layered PTFE material
that can have improved tear resistance. In some embodiments, the
graft 1204 can be formed from at least two layers of a
bi-directionally expanded PTFE material, wherein the preferred or
likely tear direction in a first layer of the material is different
than the preferred or likely tear direction in a second layer of
the material. Some embodiments of the graft 1204 and/or the tubular
members 1210, or any other graft embodiments disclosed herein, can
be formed from polyurethane or any other suitable material,
polymeric or otherwise.
[0330] Additionally, any of the stent embodiments disclosed herein,
including but not limited to the embodiments of the stent 1206
and/or any branch stent embodiments, can be self-expanding, balloon
expandable, or otherwise, and can be formed by any suitable
process. For example, without limitation, some embodiments of the
stents disclosed herein can be laser cut from a tube of suitable
material, such as Nitinol, stainless steel, or otherwise.
Additionally, any of the stent embodiments disclosed herein can be
formed as described in U.S. Pat. No. 6,077,296 or U.S. Pat. No.
7,520,895, which patents are hereby incorporated by reference in
their entireties as if fully set forth herein.
[0331] FIG. 86 illustrates calculations regarding the theoretical
axial adjustability of at least some embodiments of the grafts
disclosed herein. FIG. 87 illustrates calculations regarding the
theoretical angular or radial adjustability of at least some
embodiments of the grafts disclosed herein.
[0332] While the above detailed description has shown, described,
and pointed out novel features as applied to various embodiments,
it will be understood that various omissions, substitutions, and
changes in the form and details of the device or process
illustrated can be made without departing from the spirit of the
disclosure. Additionally, the various features and processes
described above can be used independently of one another, or can be
combined in various ways. All possible combinations and
subcombinations are intended to fall within the scope of this
disclosure.
[0333] As will be recognized, certain embodiments described herein
can be embodied within a form that does not provide all of the
features and benefits set forth herein, as some features can be
used or practiced separately from others. The scope of the
inventions is indicated by the appended claims rather than by the
foregoing description. All changes which come within the meaning
and range of equivalency of the claims are to be embraced within
their scope.
[0334] For example, while some embodiments of the delivery and
graft systems are described herein with respect to the abdominal
aortic artery, the delivery and graft systems can be used for
repairing vasculature in other portions of the body, including but
not limited to the SMA, the thoracic artery, the inferior
mesenteric artery, or any other arteries or blood vessels in the
body suitable for such procedures or apparatuses.
* * * * *