U.S. patent application number 09/728582 was filed with the patent office on 2001-09-27 for flexible vascular graft.
Invention is credited to Shaolian, Samuel M., Zeng, Frank M..
Application Number | 20010025195 09/728582 |
Document ID | / |
Family ID | 26905021 |
Filed Date | 2001-09-27 |
United States Patent
Application |
20010025195 |
Kind Code |
A1 |
Shaolian, Samuel M. ; et
al. |
September 27, 2001 |
Flexible vascular graft
Abstract
Disclosed is a tubular endoluminal vascular prosthesis, useful
in treating, for example, an abdominal aortic aneurysm. The
prosthesis comprises a self-expandable wire support structure
having a tubular main body support and first and second branch
supports. The support structure may include sliding links to permit
flexibility while maintaining patency of the central lumen. The
branch supports may articulate with the main body to permit the
branches to pivot laterally from the axis of the main body
throughout a substantial range of motion.
Inventors: |
Shaolian, Samuel M.;
(Newport Beach, CA) ; Zeng, Frank M.; (Irvine,
CA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
620 NEWPORT CENTER DRIVE
SIXTEENTH FLOOR
NEWPORT BEACH
CA
92660
US
|
Family ID: |
26905021 |
Appl. No.: |
09/728582 |
Filed: |
December 1, 2000 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09728582 |
Dec 1, 2000 |
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09251363 |
Feb 17, 1999 |
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6197049 |
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09251363 |
Feb 17, 1999 |
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09210280 |
Dec 11, 1998 |
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6187036 |
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Current U.S.
Class: |
623/1.13 ;
623/1.35; 623/903 |
Current CPC
Class: |
A61F 2002/067 20130101;
A61F 2/856 20130101; A61F 2/90 20130101; A61F 2/954 20130101; A61F
2002/828 20130101; A61F 2230/0054 20130101; A61F 2/9661 20200501;
A61F 2/89 20130101; A61F 2002/072 20130101; A61F 2220/005 20130101;
A61F 2/07 20130101; A61F 2250/0039 20130101; A61F 2/958 20130101;
A61F 2002/075 20130101; A61F 2220/0058 20130101; A61F 2220/0075
20130101; A61F 2002/065 20130101 |
Class at
Publication: |
623/1.13 ;
623/1.35; 623/903 |
International
Class: |
A61F 002/06 |
Claims
What is claimed is:
1. A tubular wire support for a bifurcated endoluminal prosthesis,
said wire support comprising: a main body support structure having
a proximal end, a distal end and a central lumen extending along a
longitudinal axis therethrough; a first branch support structure
having a proximal end, a distal end and a central lumen
therethrough, wherein the distal end of the first branch support
structure is pivotably connected to the proximal end of the main
body support structure; a second branch support structure having a
proximal end, a distal end and a central lumen extending
therethrough, wherein the distal end of the second branch support
structure is pivotably connected to the proximal end of the main
body support structure; and at least two slidable links in the main
body support structure to permit flexing of the main body.
2. The tubular wire support of claim 1, further comprising a
tubular sheath on the wire support.
3. The tubular wire support of claim 2, wherein the sheath
comprises a PTFE sleeve surrounding at least a central portion of
the wire support.
4. The tubular wire support of claim 1, wherein the main body
support structure and the first and second branch support structure
are self-expandable from a radially collapsed state to a radially
expanded state.
5. The tubular wire support of claim 1, wherein the wire in each
support structure comprises a series of proximal bends, a series of
distal bends, and a series of struts connecting the proximal and
distal bends to form a tubular segment.
6. The tubular wire support of claim 5, wherein each tubular
segment comprises from about 4 proximal bends to about 12 proximal
bends.
7. The tubular wire support of claim 1, wherein the first and
second branch supports structures are pivotably attached to the
main body support structure.
8. A tubular wire support for combination with a sheath to produce
a bifurcated endoluminal prosthesis, said tubular wire support
comprising: a main body support structure having a proximal end, a
distal end and a central lumen extending therethrough and at least
a first and second axially adjacent zig-zag tubular segments; a
first branch support structure having a proximal end, a distal end
and a central lumen therethrough connected to the main body support
structure; and a second branch support structure having a proximal
end, a distal end and a central lumen extending therethrough,
connected to the main body support structure, wherein the first and
second segments are joined to each other by a plurality of sliding
links.
9. The tubular wire support of claim 8, wherein the main body
support structure and the first and second branch support structure
are self-expandable from a radially collapsed state to a radially
expanded state.
10. A tubular wire support as in claim 9, wherein the tubular wire
support has an expansion ratio of at least about 1:4.
11. A flexible self expandable graft, comprising: a tubular main
body support structure having a proximal end and a distal end, the
tubular body comprising a first tubular segment attached to a
second tubular segment; a tubular polymeric sleeve surrounding at
least a portion of the graft; wherein each of the first and second
tubular segments comprise a plurality of proximal bends and distal
bends connected by struts, and the first segment comprises at least
one more proximal bend than the second segment.
12. An articulating bifurcation graft as in claim 11, further
comprising at least a first and second sliding link between the
first and second tubular segments.
13. An endoluminal prosthesis, comprising: a tubular wire support
having a proximal end, a distal end and a central lumen extending
therethrough; the wire support comprising at least a first and a
second axially adjacent tubular segment, each tubular segment
comprising a series of proximal and distal bends; and at least two
sliding links between the first tubular segment and the second
tubular segment.
14. An endoluminal prosthesis as in claim 13, comprising at least
four sliding links between the first and second segments.
15. An endoluminal prosthesis as in claim 14, comprising at least
four segments.
16. An endoluminal prosthesis as in claim 13, comprising a series
of struts connecting the proximal bends and distal bends within a
segment to form a tubular segment wall, wherein at least some of
the struts are substantially linear.
17. An endoluminal prosthesis as in claim 16, wherein the sliding
link comprises a proximal bend or distal bend on a first segment
slidably engaged with a strut on an adjacent segment.
18. An endoluminal prosthesis as in claim 13, wherein each segment
comprises from about 4 proximal bends to about 12 proximal
bends.
19. An endoluminal prosthesis as in claim 13, having at least a
proximal segment, an intermediate segment and a distal segment,
wherein the prosthesis is expandable from a reduced cross section
to an expanded cross section.
20. An endoluminal prosthesis as in claim 19, wherein at least a
portion of the proximal segment is larger in cross section than the
central segment when the prosthesis is in the expanded cross
section.
21. An endoluminal prosthesis as in claim 13, further comprising a
polymeric layer on the wire support.
22. An endoluminal prosthesis as in claim 21, wherein the layer
comprises a tubular PTFE sleeve surrounding at least a portion of
the prosthesis.
23. A multizone endoluminal prosthesis, comprising: a tubular wire
support having a proximal end, a distal end and a central lumen
extending therethrough; the wire support comprising at least a
first and a second axially adjacent tubular segments, each tubular
segment comprising a series of proximal and distal bends; wherein
the first tubular segment has a different number of proximal bends
than the second tubular segment.
24. An endoluminal prosthesis as in claim 23, wherein a proximal
end of the prosthesis is self expandable to a greater diameter than
a central region of the prosthesis.
25. A multizone endoluminal prosthesis as in claim 23, further
comprising a sliding link on at least one of the proximal
bends.
26. A multizone endoluminal prosthesis as in claim 23, further
comprising an eye on at least one of the distal bends.
27. An endoluminal prosthesis, comprising an elongate flexible
wire, formed into a plurality of axially adjacent tubular segments
spaced along an axis, each tubular segment comprising a zig-zag
section of the wire, having a plurality of proximal bends and
distal bends, at least one of the plurality of proximal bends and
plurality of distal bends having loops thereon, with the wire
continuing between each adjacent tubular segment, wherein the
prosthesis is radially compressible into a first, reduced cross
sectional configuration for implantation into a body lumen, and
self expandable to a second, enlarged cross sectional configuration
at a treatment site in a body lumen, and wherein at least some of
the bends in one tubular segment are slidably connected to at least
some of the wall sections in the adjacent tubular segment.
28. An endoluminal prosthesis as in claim 27, comprising at least
three segments formed from said wire.
29. An endoluminal prosthesis as in claim 28, further comprising an
outer tubular sleeve surrounding at least a portion of the
prosthesis.
30. An endoluminal prosthesis as in claim 29, wherein the sleeve
further comprises at least one lateral perfusion port extending
therethrough.
31. An endoluminal prosthesis as in claim 28, wherein the
prosthesis has a proximal end and a distal end, and at least one of
the proximal end and distal end are expandable to a larger diameter
than a central section of the prosthesis in an unconstrained
expansion.
32. An endoluminal prosthesis as in claim 27, wherein the
prosthesis has an expansion ratio of at least about 1:4.
33. An endoluminal prosthesis as in claim 32, wherein the
prosthesis has an expansion ratio of at least about 1:5.
34. An endoluminal prosthesis as in claim 27, wherein the
prosthesis has an expanded diameter of at least about 20 mm in an
unconstrained expansion, and the prosthesis is implantable using a
catheter no greater than about 20 French.
35. A prosthesis as in claim 34, wherein the prosthesis has an
expanded diameter of at least about 25 mm, and is implantable on a
delivery device having a diameter of no more than about 20 French.
Description
[0001] This is a continuation-in-part of U.S. patent application
Ser. No. 09/251,363, filed Feb. 17, 1999, entitled "Articulated
Bifurcation Graft," which is a continuation-in-part of U.S. patent
application Ser. No. 09/210,280, filed Dec. 11, 1998, entitled
"Endoluminal Vascular Prosthesis."
BACKGROUND OF THE INVENTION
[0002] The present invention relates to an endoluminal vascular
prosthesis, and in particular, to a self-expanding bifurcated
prosthesis for use in the treatment of abdominal aortic
aneurysms.
[0003] 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 which 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.
[0004] 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.RTM., TEFLON.RTM., or other suitable
material.
[0005] 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 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.RTM. 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.
[0006] 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.
[0007] 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. The graft must be
secured, or sutured, to the remaining portion of the aorta, which
may be difficult to perform because of the thrombosis present on
the remaining portion of the aorta. Moreover, the remaining portion
of the aorta wall is frequently friable, or easily crumbled.
[0008] 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.
[0009] More recently, a significantly less invasive clinical
approach to aneurysm repair, known as endovascular graffing, 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
within the lumen of the artery.
[0010] In general, transluminally implantable prostheses adapted
for use in the abdominal aorta comprise a tubular wire cage
surrounded by a tubular PTFE or Dacron sleeve. Both balloon
expandable and self expandable support structures have been
proposed. Endovascular grafts adapted to treat both straight
segment and bifurcation aneurysms have also been proposed.
[0011] Notwithstanding the foregoing, there remains a need for a
structurally simple, easily deployable transluminally implantable
endovascular prosthesis, with a support structure adaptable to span
either a straight or bifurcated abdominal aortic aneurysm.
Preferably, the tubular prosthesis can be self expanded at the site
to treat the abdominal aortic aneurysm, and exhibits flexibility to
accommodate nonlinear anatomies and normal anatomical movement.
SUMMARY OF THE INVENTION
[0012] In accordance with one aspect of the present invention,
there is provided a tubular wire support for a bifurcated
endoluminal prosthesis. The wire support comprises a main body
support structure having a proximal end, a distal end, and a
central lumen extending along a longitudinal axis therethrough. A
first branch support structure having a proximal end, a distal end
and a central lumen therethrough is provided, in which the distal
end of the first branch support structure is pivotably connected to
the proximal end of the main body support structure. A second
branch support structure is provided, having a proximal end, a
distal end and a central lumen extending therethrough, and the
distal end of the second branch support structure is pivotably
connected to the proximal end of the main body support structure.
At least two slidable links are provided in the main body support
structure to permit lateral flexing of the main body, while
maintaining patency of the central lumen.
[0013] Preferably, the wire support is further provided with a
tubular sheath on at least a portion thereof. In one embodiment,
the sheath comprises expanded PTFE. The main body support structure
is preferably self-expandable from a radially collapsed state to a
radially expanded state. In one embodiment, at least one of the
main body and the first and second branch support structures has a
noncylindrical exterior configuration in a fully expanded
state.
[0014] In accordance with another aspect of the present invention,
there is provided a tubular wire support for combination with a
sheath to produce a bifurcated endoluminal prosthesis. The tubular
wire support comprises a main body support structure having a
proximal end, a distal end and a central lumen extending
therethrough. At least a first and a second axially adjacent
zig-zag tubular segments make up the main body support structure. A
first branch support structure having a proximal end, a distal end,
and a central lumen therethrough is connected to the main body
support structure. A second branch structure having a proximal end,
a distal end and a central lumen extending therethrough is
connected to the main body support structure. The first and second
segments are preferably joined to each other by way of a plurality
of sliding links.
[0015] In accordance with a further aspect of the present
invention, there is provided a flexible, self-expandable straight
segment graft. The graft comprises a tubular main body support
structure having a proximal end and a distal end. The tubular body
comprises a first tubular segment attached to at least a second
tubular segment. A tubular polymeric sleeve surrounds at least a
portion of the graft. Each of the first and second tubular segments
comprises a plurality of proximal bends and distal bends connected
by struts, and the first segment comprises at least one more
proximal bend than the second segment. The foregoing tapered
straight segment graft may be utilized either as a straight segment
graft, or a straight segment component on a bifurcation graft.
[0016] In accordance with another aspect of the present invention,
there is provided a flexible endoluminal prosthesis. The prosthesis
comprises a tubular wire support, having a proximal end, a distal
end, and a central lumen extending therethrough. The wire support
comprises at least a first and a second axially adjacent tubular
segments, each tubular segment comprising a series of proximal and
distal bends. At least two sliding links are provided between the
first tubular segment and the second tubular segment to permit
axial compression of a portion of the tubular segment to enable
curving of the prosthesis.
[0017] In one embodiment, at least four sliding links are provided
between the first and second segments. In addition, at least four
segments may be provided. Each segment comprises a series of
struts, connecting the proximal bends and distal bends to form a
tubular segment wall. In one embodiment, at least some of the
struts are substantially linear. The sliding link preferably
comprises a proximal bend or a distal bend on a first segment which
slidably engages with a strut on an adjacent segment. In one
embodiment, a first portion of the prosthesis is radially
expandable to a different expanded diameter than a second portion
of the prosthesis. Preferably, the prosthesis has an expanded
diameter of at least about 20 millimeters in an unconstrained
expansion, and the prosthesis is implantable using a catheter of no
greater than about 22 French, and preferably no greater than about
16 French.
[0018] Further features and advantages of the present invention
will become apparent to those of ordinary skill in the art in view
of the disclosure herein, when considered together with the
attached drawings and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 is a schematic representation of a straight segment
vascular prosthesis in accordance with the present invention,
positioned within a symmetric abdominal aortic aneurysm.
[0020] FIG. 2 is an exploded view of an endoluminal vascular
prosthesis in accordance with the present invention, showing a self
expandable wire support structure separated from an outer tubular
sleeve.
[0021] FIG. 3 is a plan view of a formed wire useful for rolling
about an axis into a multi-segment support structure in accordance
with the present invention.
[0022] FIG. 4 is an enlarged detail view of a portion of the formed
wire illustrated in FIG. 3.
[0023] FIG. 5 is a schematic view of a portion of a wire cage wall,
illustrating folded link connections between adjacent apexes.
[0024] FIG. 6 is an exploded view of two opposing apexes
dimensioned for one embodiment of the folded link connection of the
present invention.
[0025] FIG. 7 is an enlarged view of a folded link, taken along the
lines 7-7 in FIG. 5.
[0026] FIG. 8 is a cross-sectional view taken along the line 8-8 in
FIG. 7.
[0027] FIGS. 6A, 7A, 8A, 7B, 8B, 7C, and 7D illustrate alternate
embodiments of a folded link constructed from an opposing apex
pair.
[0028] FIG. 9 is a partial view of a junction between two adjacent
tubular segments, illustrating oppositely oriented folded links in
accordance with the present invention.
[0029] FIG. 10 is a cross-section taken along the line 10-10 in
FIG. 9.
[0030] FIG. 11 is a schematic view of a portion of a wall of a
graft, laid out flat, illustrating an alternating folded link
pattern.
[0031] FIG. 12 is a wall pattern as in FIG. 11, illustrating a
multi-zone folded link pattern.
[0032] FIGS. 12A through 12C illustrate an alternate wall pattern,
which permits axially staggered links between adjacent graft
segments.
[0033] FIG. 13 is a schematic illustration of a straight segment
delivery catheter in accordance with the present invention,
positioned within an abdominal aortic aneurysm.
[0034] FIG. 14 is an illustration as in FIG. 13, with the straight
segment endoluminal prosthesis partially deployed from the delivery
catheter.
[0035] FIG. 15 is a schematic representation of the abdominal
aortic anatomy, with an endoluminal vascular prostheses of the
present invention positioned within each of the right renal artery
and the right common iliac.
[0036] FIG. 16 is a schematic representation of a straight segment
graft in accordance with a further embodiment of the present
invention, with side openings to permit renal perfusion.
[0037] FIG. 17 is a schematic representation of a bifurcated
vascular prosthesis in accordance with the present invention,
positioned at the bifurcation between the abdominal aorta and the
right and left common iliac arteries.
[0038] FIG. 18 is a cross-sectional view of the implanted graft
taken along the lines 18-18 of FIG. 17.
[0039] FIG. 19 is an exploded view of the bifurcated vascular
prosthesis in accordance with the present invention, showing a
two-part self expandable wire support structure separated from an
outer tubular sleeve.
[0040] FIG. 20 is a plan view of formed wire useful for rolling
about an axis into an aortic trunk segment and a first iliac branch
segment support structure in accordance with the present
invention.
[0041] FIG. 21 is a schematic representation of another embodiment
of the wire support structure for the bifurcated vascular
prosthesis of the present invention, showing a main body support
structure and separate branch support structures.
[0042] FIG. 22 is a schematic representation of the three-part wire
support structure as in FIG. 21, illustrating the sliding
articulation between the branch supports and the main body
support.
[0043] FIG. 23 is a plan view of formed wire useful for rolling
about an axis to form a branch support structure in accordance with
the three-part support embodiment of the present invention shown in
FIG. 21.
[0044] FIGS. 24A, 24B and 24C are enlargements of the apexes
delineated by lines A, B and C, respectively, in FIG. 23.
[0045] FIG. 25 is side elevational cross-section of a bifurcation
graft delivery catheter in accordance with the present
invention.
[0046] FIG. 26 is an enlargement of the portion delineated by the
line 26-26 in FIG. 25.
[0047] FIG. 27 is a cross-section taken along the line 27-27 in
FIG. 26.
[0048] FIG. 28 is a cross-section taken along the line 28-28 in
FIG. 26.
[0049] FIG. 29 is a schematic representation of a bifurcated graft
deployment catheter of the present invention, positioned within the
ipsilateral iliac and the aorta, with the contralateral guidewire
positioned within the contralateral iliac.
[0050] FIG. 30 is a schematic representation as in FIG. 29, with
the outer sheath proximally retracted and the compressed iliac
branches of the graft moving into position within the iliac
arteries.
[0051] FIG. 31 is a schematic representation as in FIG. 30, with
the compressed iliac branches of the graft within the iliac
arteries, and the main aortic trunk of the graft deployed within
the aorta.
[0052] FIG. 32 is a schematic representation as in FIG. 31, with
the contralateral iliac branch of the graft deployed.
[0053] FIG. 33 is a schematic representation as in FIG. 32,
following deployment of the ipsilateral branch of the graft.
[0054] FIG. 34a is a side elevational view of a flexible straight
graft in accordance with the present invention.
[0055] FIG. 34b is a detail view of a sliding link in the
embodiment of FIG. 34a.
[0056] FIG. 34c is a side elevational view of the graft of FIG.
34a, having a radius of curvature.
[0057] FIG. 35a is a side elevational view of a bifurcated graft
which includes sliding links in accordance with the present
invention.
[0058] FIG. 35b is a detail view of a sliding link in a proximal
portion of the graft of FIG. 35a.
[0059] FIG. 35c is a detail view of a folded link utilized in an
intermediate zone of the graft of FIG. 35a.
[0060] FIG. 35d is a detail view of a sliding link utilized in the
iliac branches of the graft of FIG. 35a.
[0061] FIG. 36 is a side elevational view of a tapered bifurcated
graft in accordance with the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0062] Referring to FIG. 1, there is disclosed a schematic
representation of the abdominal part of the aorta and its principal
branches. In particular, the abdominal aorta 30 is characterized by
a right renal artery 32 and left renal artery 34. The large
terminal branches of the aorta are the right and left common iliac
arteries 36 and 38. Additional vessels (e.g., second lumbar,
testicular, inferior mesenteric, middle sacral) have been omitted
for simplification. A generally symmetrical aneurysm 40 is
illustrated in the infrarenal portion of the diseased aorta. An
expanded straight segment endoluminal vascular prosthesis 42, in
accordance with the present invention, is illustrated spanning the
aneurysm 40.
[0063] The endoluminal vascular prosthesis 42 includes a polymeric
sleeve 44 and a tubular wire support 46, which are illustrated in
situ in FIG. 1. The sleeve 44 and wire support 46 are more readily
visualized in the exploded view shown in FIG. 2. The endoluminal
prosthesis 42 illustrated and described herein depicts an
embodiment in which the polymeric sleeve 44 is situated
concentrically outside of the tubular wire support 46. However,
other embodiments may include a sleeve situated instead
concentrically inside the wire support or on both of the inside and
the outside of the wire support. Alternatively, the wire support
may be embedded within a polymeric matrix which makes up the
sleeve. Regardless of whether the sleeve 44 is inside or outside
the wire support 46, the sleeve may be attached to the wire support
by any of a variety of means, including laser bonding, adhesives,
clips, sutures, dipping or spraying or others, depending upon the
composition of the sleeve 44 and overall graft design.
[0064] The polymeric sleeve 44 may be formed from any of a variety
of synthetic polymeric materials, or combinations thereof,
including PTFE, PE, PET, Urethane, Dacron, nylon, polyester or
woven textiles. Preferably, the sleeve material exhibits relatively
low inherent elasticity, or low elasticity out to the intended
enlarged diameter of the wire cage 46. The sleeve material
preferably has a thin profile, such as no larger than about 0.002
inches to about 0.005 inches.
[0065] In a preferred embodiment of the invention, the material of
sleeve 44 is sufficiently porous to permit ingrowth of endothelial
cells, thereby providing more secure anchorage of the prosthesis
and potentially reducing flow resistance, sheer forces, and leakage
of blood around the prosthesis. Porosity in polymeric sleeve
materials may be estimated by measuring water permeability as a
function of hydrostatic pressure, which will preferably range from
about 3 to 6 psi.
[0066] The porosity characteristics of the polymeric sleeve 44 may
be either homogeneous throughout the axial length of the prosthesis
42, or may vary according to the axial position along the
prosthesis 42. For example, referring to FIGS. 1 and 2, different
physical properties will be called upon at different axial
positions along the prosthesis 42 in use. At least a proximal
portion 55 and a distal portion 59 of the prosthesis 42 will seat
against the native vessel wall, proximally and distally of the
aneurysm. In these proximal and distal portions, the prosthesis
preferably encourages endothelial growth, or, at least, permits
endothelial growth to infiltrate portions of the prosthesis in
order to enhance anchoring and minimize leakage. A central portion
57 of the prosthesis spans the aneurysm, and anchoring is less of
an issue. Instead, maximizing lumen diameter and minimizing blood
flow through the prosthesis wall become primary objectives. Thus,
in a central zone 57 of the prosthesis 42, the polymeric sleeve 44
may either be nonporous, or provided with pores of relatively lower
porosity.
[0067] A multi-zoned prosthesis 42 may also be provided in
accordance with the present invention by positioning a tubular
sleeve 44 on a central portion 57 of the prosthesis, such that it
spans the aneurysm to be treated, but leaving a proximal attachment
zone 55 and a distal attachment zone 59 of the prosthesis 42 having
exposed wires from the wire support 46. In this embodiment, the
exposed wires 46 are positioned in contact with the vessel wall
both proximally and distally of the aneurysm, such that the wire,
over time, may become embedded in cell growth on the interior
surface of the vessel wall.
[0068] In one embodiment of the prosthesis 42, the sleeve 44 and/or
the wire support 46 is tapered, having a relatively larger expanded
diameter at the proximal end 50 compared to the distal end 52. See,
e.g., FIG. 36, discussed below. The tapered design may allow the
prosthesis to conform better to the natural decreasing distal
cross-section of the vessel, to reduce the risk of graft migration
and potentially create better flow dynamics. The cage 46 can be
provided with a proximal zone 55 and distal zone 59 that have a
larger average expanded diameter than the central zone 57, as
illustrated in FIG. 2. This configuration may desirably resist
migration of the prosthesis within the vessel and reduce leakage
around the ends of the prosthesis.
[0069] The tubular wire support 46 is preferably formed from a
continuous single length of round or flattened wire. Alternatively,
two or more wire lengths can be secured together to produce the
wire support 46. The wire support 46 is preferably formed in a
plurality of discrete tubular segments 54, connected together and
oriented about a common axis. Each pair of adjacent segments 54 is
connected by a connector 66 as illustrated in FIG. 3. The
connectors 66 collectively produce a generally axially extending
backbone which adds axial strength to the prosthesis 42. Adjacent
segments can be connected both by the backbone, as well as the
interlocking junction disclosed below. Additional structures,
including circumferentially extending sutures, solder joints, and
wire loops may also be used.
[0070] The segmented configuration of the tubular wire support 46
facilitates a great deal of flexibility. Each segment 54, though
joined to adjacent segments, may be independently engineered to
yield desired parameters. Each segment may range in axial length
from about 0.3 to about 5 cm. Generally, the shorter their length
the greater the radial strength. An endoluminal prosthesis may
include from about 1 to about 50 segments, preferably from about 3
to about 10 segments. For example, while a short graft patch, in
accordance with the invention, may comprise only 2 segments and
span a total of 2 to 3 cm, a complete graft may comprise 4 or more
segments and span the entire aortic aneurysm. In addition to the
flexibility and other functional benefits available through
employment of different length segments, further flexibility can be
achieved through adjustments in the number, angle, or configuration
of the wire bends associated with the tubular support. See, e.g.,
FIGS. 34 and 35, discussed below.
[0071] In addition to having differing expanded diameters in
different zones of the prosthesis 42, different zones can be
provided with a different radial expansion force, such as ranging
from about 0.2 lbs to about 0.8 lbs. In one embodiment, the
proximal zone 55 is provided with a greater radial force than the
central zone 57 and/or distal zone 59. The greater radial force can
be provided in any of a variety of manners discussed elsewhere
herein, such as through the use of an additional one or two or
three or more proximal bends 60, distal bends 62 and wall sections
64 compared to a reference segment 54 in the central zone 57 or
distal zone 59. Alternatively, additional spring force can be
achieved in the proximal zone 55 through the use of the same number
of proximal bends 60 as in the rest of the prosthesis, but with a
heavier gauge wire.
[0072] The wire may be made from any of a variety of different
alloys, such as elgiloy, nitinol or MP35N, or other alloys which
include nickel, titanium, tantalum, or stainless steel, high Co--Cr
alloys or other temperature sensitive materials. For example, an
alloy comprising Ni 15%, Co 40%, Cr 20%, Mo 7% and balance Fe may
be used. The tensile strength of suitable wire is generally above
about 300 Ksi and often between about 300 and about 340 Ksi for
many embodiments. In one embodiment, a Chromium-Nickel-Molybdenum
alloy such as that marketed under the name Conichrom (Fort Wayne
Metals, Indiana) has a tensile strength ranging from 300 to 320 K
psi, elongation of 3.5-4.0%. The wire may be treated with a plasma
coating and be provided with or without additional coatings such as
PTFE, Teflon, Perlyne and drugs.
[0073] In addition to segment length and bend configuration,
discussed above, another determinant of radial strength is wire
gauge. The radial strength, measured at 50% of the collapsed
profile, preferably ranges from about 0.2 lb to 0.8 lb, and
generally from about 0.4 lb to about 0.5 lb. or more. Preferred
wire diameters in accordance with the present invention range from
about 0.004 inches to about 0.020 inches. More preferably, the wire
diameters range from about 0.006 inches to about 0.018 inches. In
general, the greater the wire diameter, the greater the radial
strength for a given wire layout. Thus, the wire gauge can be
varied depending upon the application of the finished graft, in
combination with/or separate from variation in other design
parameters (such as the number of struts, or proximal bends 60 and
distal bends 62 per segment), as will be discussed. A wire diameter
of approximately 0.018 inches may be useful in a graft having four
segments each having 2.5 cm length per segment, each segment having
six struts intended for use in the aorta, while a smaller diameter
such as 0.006 inches might be useful for a 0.5 cm segment graft
having 5 struts per segment intended for the iliac artery. The
length of cage 42 could be as long as about 28 cm.
[0074] In one embodiment of the present invention, the wire
diameter is tapered from the proximal to distal ends.
Alternatively, the wire diameter may be tapered incrementally or
stepped down, or stepped up, depending on differing radial strength
requirements along the length of the graft for each particular
clinical application. In one embodiment, intended for the abdominal
aortic artery, the wire has a cross-section of about 0.018 inches
in the proximal zone 55 and the wire tapers down to a diameter of
about 0.006 inches in the distal zone 59 of the graft 42. End point
dimensions and rates of taper can be varied widely, within the
spirit of the present invention, depending upon the desired
clinical performance.
[0075] Referring to FIG. 3, there is illustrated a plan view of a
single formed wire used for rolling about a longitudinal axis to
produce a four segment straight tubular wire support. The formed
wire exhibits distinct segments, each corresponding to an
individual tubular segment 54 in the tubular support (see FIGS. 1
and 2).
[0076] Each segment has a repeating pattern of proximal bends 60
connected to corresponding distal bends 62 by wall sections 64
which extend in a generally zig-zag configuration when the segment
54 is radially expanded. Each segment 54 is connected to the
adjacent segment 54 through a connector 66, except at the terminal
ends of the graft. The connector 66 in the illustrated embodiment
comprises two wall or strut sections 64 which connect a proximal
bend 60 on a first segment 54 with a distal bend 62 on a second,
adjacent segment 54. The connector 66 may additionally be provided
with a connector bend 68, which may be used to impart increased
radial strength to the graft and/or provide a tie site for a
circumferentially extending suture.
[0077] Referring to FIG. 4, there is shown an enlarged view of the
wire support illustrating a connector 66 portion between adjacent
segments 54. In the embodiment shown in FIG. 4, a proximal bend 60
comprises about a 180 degree arc, having a radial diameter of (w)
(Ranging from 0.070 to 0.009 inches), depending on wire diameter
followed by a relatively short length of parallel wire spanning an
axial distance of d1. The parallel wires thereafter diverge
outwardly from one another and form the strut sections 64, or the
proximal half of a connector 66. At the distal end of the strut
sections 64, the wire forms a distal bend 62, preferably having
identical characteristics as the proximal bend 60, except being
concave in the opposite direction. The axial direction component of
the distance between the apices of the corresponding proximal and
distal bends 60, 62 on a given strut section 64 is referred to as
(d) and represents the axial length of that segment. The total
expanded angle defined by the bend 60 and the divergent strut
sections 64 is represented by .alpha.. Upon compression to a
collapsed state, such as when the graft is within the deployment
catheter, the angle .alpha. is reduced to .alpha.'. In the expanded
configuration, .alpha. is generally within the range of from about
35.degree. to about 45.degree. for a six apex section having an
axial length of about 1.5 cm or 2 cm and a diameter of about 25 mm
or 28 mm. The expanded circumferential distance between any two
adjacent distal bends 62 (or proximal bends 60) is defined as
(s).
[0078] In general, the diameter W of each proximal bend 60 or
distal bend 62 is within the range of from about 0.009 inches to
about 0.070 inches depending upon the wire diameter. Diameter W is
preferably as small as possible for a given wire diameter and wire
characteristics. As will be appreciated by those of skill in the
art, as the distance W is reduced to approach two times the
cross-section of the wire, the bend 60 or 62 will exceed the
elastic limit of the wire, and radial strength of the finished
segment will be lost. Determination of a minimum value for W, in
the context of a particular wire diameter and wire material, can be
readily determined through routine experimentation by those of
skill in the art.
[0079] As will be appreciated from FIG. 3 and 4, the sum of the
distances (s) in a plane transverse to the longitudinal axis of the
finished graft will correspond to the circumference of the finished
graft cage in that plane. For a given circumference, the number of
proximal bends 60 or distal bends 62 is directly related to the
distance (s) in the corresponding plane. Preferably, the finished
graft in any single transverse plane will have from about 3 to
about 10 (s) dimensions, preferably from about 4 to about 8 (s)
dimensions and, more preferably, about 5 or 6 (s) dimensions for an
aortic application. Each (s) dimension corresponds to the distance
between any two adjacent bends 60-60 or 62-62 as will be apparent
from the discussion herein. Each segment 54 can thus be visualized
as a series of triangles extending circumferentially around the
axis of the graft, defined by a proximal bend 60 and two distal
bends 62 or the reverse.
[0080] In one embodiment of the type illustrated in FIG. 4, w is
about 2.0 mm.+-.1 mm for a 0.018 inch wire diameter. D1 is about 3
mm.+-.1 mm, and d is about 20 mm.+-.1 mm. Specific dimensions for
all of the foregoing variables can be varied considerably,
depending upon the desired wire configuration, in view of the
disclosure herein.
[0081] Referring to FIGS. 5 and 6, one or more apexes 76 is
provided with an elongated axial length d2, which permits the apex
76 to be wrapped around a corresponding portion 78 such as an apex
of the adjacent segment to provide an interlocking link 70 between
two axially adjacent cage segments. In one embodiment of the link
70 produced by the opposing apexes 76 and 78 of FIG. 6, utilizing
wire having a diameter from 0.012" to 0.018", d1 is generally
within the range of from about 1 mm to about 4 mm and d2 is within
the range of from about 5 mm to about 9 mm. In general, a longer d2
dimension permits accommodation for greater axial travel of apex 78
with respect to 76, as will be discussed, thereby permitting
greater lateral flexibility of the graft. W1 is within the range of
from about 3 mm to about 5 mm, and W2 is sufficiently less than W1
that the apex 76 can fit within the apex 78. Any of a wide variety
of specific apex configurations and dimensions can be utilized, as
will be apparent to those of skill in the art in view of the
disclosure herein. Regardless of the specific dimensions, the end
of the apex 76 is advanced through the apex 78, and folded back
upon its self to hook the apex 78 therein to provide a link 70 in
accordance with the present invention.
[0082] The resulting link 70 (see FIGS. 7 and 8) comprises a wall
portion 71 extending in a first direction, substantially parallel
to the axis of the graft, and a transverse portion 72 extending
transverse to the axis of the graft. A return portion 73 extends
generally in the opposite direction from the wall portion 71 to
create a generally "U" shaped hook. In certain embodiments, a
closing portion 74 is also provided, to minimize the risk of
excessive axial compression of the wire cage. The forgoing
structure produces a functionally closed aperture 77, which
receives the interlocking section 75 of the adjacent graft segment.
Alternatively, see FIG. 10.
[0083] In general, the aperture 77 preferably has a width (as
viewed in FIG. 8) in the radial graft direction of substantially
equal to the radial direction dimension of the interlocking section
75. In this embodiment, the interlocking section 75, as well as the
locking portion 71 and return portion 73 can be flattened in the
radial direction, to minimize the transverse cross-section of the
link 70. In the axial direction, the aperture 77 is preferably
greater than the axial direction dimension of the interlocking
section 75, to accommodate some axial movement of each adjoining
tubular segment of the graft. The axial length of the aperture 77
is at least about 2 times, and preferably at least about 3 or 4
times the cross-section of the interlocking section 75. The optimum
axial length of the aperture 77 can be determined through routine
experimentation by one of skill in the art in view of the intended
clinical performance, taking into account the number of links 70
per transverse plane as well as the desired curvature of the
finished graft.
[0084] FIGS. 6A, 7A and 8A illustrate an alternate configuration
for the moveable link 70. With this configuration, the radial
expansion force will be higher.
[0085] FIGS. 7B and 8B illustrate another alternate configuration.
This linkage has a better resistance to axial compression and
disengagement. Referring to FIGS. 7B and 8B, the apex extends
beyond closing portion 74 and into an axial portion 79 which
extends generally parallel to the longitudinal axis of the graft.
Provision of an axial extension 79 provides a more secure enclosure
for the aperture 77 as will be apparent to those of skill in the
art. The embodiments of FIG. 7B and 8B also illustrate an enclosed
aperture 83 on the opposing apex. The aperture 83 is formed by
wrapping the apex in at least one complete revolution so that a
generally circumferentially extending portion 81 is provided.
Circumferential portion 81 provides a stop, to limit axial
compressibility of the graft. The closed aperture 83 can be formed
by winding the wire of the apex about a mandrel either in the
direction illustrated in FIG. 7B, or the direction illustrated in
FIG. 7C. The embodiment of FIG. 7C advantageously provided only a
single wire thickness through the aperture 77, thereby minimizing
the wall thickness of the graft. This is accomplished by moving the
crossover point outside of the aperture 77, as will be apparent
from FIG. 7C.
[0086] The link 70 in accordance with the present invention is
preferably formed integrally with the wire which forms the cage of
the endovascular prosthesis. Alternatively, link 70 may be
constructed from a separate material which is secured to the wire
cage such as by soldering, suture, wrapping or the like.
[0087] The axial direction of the link 70 may also be varied,
depending upon the desired performance characteristics of the
graft. For example, the distal tips 76 of each link 70 may all face
the same direction, such as proximal or distal with respect to the
graft. See, for example, FIG. 5. Alternatively, one or more links
in a given transverse plane of apexes may face in a proximal
direction, and one or more links in the same transverse plane may
face in the opposite direction. See, for example, FIG. 9.
[0088] Regardless of the axial orientation of the link 70, at least
one and preferably at least two links 70 are provided per
transverse plane separating adjacent graft segments. In an
embodiment having six apexes per transverse plane, preferably at
least two or three and in one embodiment all six opposing apex
pairs are provided with a link 70. See FIG. 5.
[0089] The distribution of the interlocking link 70 throughout the
wire cage can thus vary widely, depending upon the desired
performance characteristics. For example, each opposing apex pair
between adjacent tubular segments can be provided with a link 70.
See FIG. 5. Alternatively, interlocking links 70 may be spaced
circumferentially apart around the graft wall such as by
positioning them at every second or third opposing apex pair.
[0090] The distribution of the links 70 may also be varied along
the axial length of the graft. For example, a first zone at a
proximal end of the graft and a second zone at a distal end of the
graft may be provided with a relatively larger number of links 70
than a third zone in the central portion of the graft. In one
embodiment, the transverse apex plane between the first and second
tubular segments at the proximal end of the graft may be provided
with a link 70 at each opposing apex pair. This has been determined
by the present inventors to increase the radial strength of the
graft, which may be desirable at the proximal (superior) end of the
graft and possibly also at the distal end of the graft where
resistance to leakage is an issue. A relatively lesser radial
strength may be necessary in the central portion of the graft,
where maintaining patency of the lumen is the primary concern. For
this reason, relatively fewer links 70 may be utilized in a central
zone, in an effort to simplify graft design as well as reduce
collapse profile of the graft. See FIG. 12.
[0091] In one straight segment graft, having four graft segments,
three transverse apex planes are provided. In the proximal apex
plane, each opposing pair of apexes is provided with a link 70. In
the central transverse apex plane, three of the six apex pairs are
provided with a links 70, spaced apart at approximately
120.degree.. Substantially equal circumferential spacing of the
link 70 is preferred, to provide relatively uniform resistance to
bending regardless of graft position. The distal transverse apex
plane may also be provided with a link 70 at each opposing apex
pair.
[0092] The foregoing interlocking link 70 in accordance with the
present invention can be readily adapted to both the straight
segment grafts as discussed above, as well as to the bifurcated
grafts discussed below.
[0093] The interlocking link 70 can be utilized to connect any of a
number of independent graft segments in axial alignment to produce
either a straight segment or a bifurcation graft. The interlocking
link 70 may be utilized as the sole means of securing adjacent
segments to each other, or may be supplemented by additional
attachment structures such as metal loops, sutures, welds and
others which are well understood in the art.
[0094] Referring to FIGS. 12A through 12C there is illustrated a
further wire layout which allows a smaller collapsed profile for
the vascular graft. In general, the embodiment of FIGS. 12A through
12C permits a series of links 70A and 70B to be staggered axially
from one another as seen in FIG. 12A and 12B. In this manner,
adjacent links 70 do not lie in the same transverse plane, and
permit a tighter nesting of the collapsed wire cage. Preferably,
between each adjoining graft segment, at least a first group of
links 70A is offset axially from a second group of links 70B. In a
six apex graft, having a link 70 at each apex, for example, a first
group of every other apex 70A may be positioned slightly proximally
of a second group of every other apex 70B. Referring to FIG. 12C,
this may be accomplished by extending an apex 76A by a d3 distance
which is at least about 1.2 times and as large as 1.5 times or 2
times or more the distance d2. The corresponding apexes 78 and 78A
are similarly staggered axially, to produce the staggered interface
between adjacent graft segments illustrated in FIG. 12A. Although a
loop apex is illustrated in FIG. 12C as apex 78, any of the
alternate apexes illustrated herein can be utilized in the
staggered apex embodiment of the invention. The zig-zag pattern
produced by axially offset links 70A and 70B can reside in a pair
of parallel transverse planes extending generally between adjacent
segments of the graft. Alternatively, the zig-zag relationship
between adjacent links 70A and 70B can spiral around the
circumference of a graft in a helical pattern, as will be
understood by those of skill in the art in view of the disclosure
herein. The precise axial offset between adjacent staggered links
70A and 70B can be optimized by one of ordinary skill in the art
through routine experimentation, taking into account the desired
physical properties and collapsed profile of the graft.
[0095] Referring to FIGS. 13 and 14, a straight segment deployment
device and method in accordance with a preferred embodiment of the
present invention are illustrated. A delivery catheter 80, having a
dilator tip 82, is advanced along guidewire 84 until the
(anatomically) proximal end 50 of the collapsed endoluminal
vascular prosthesis 88 is positioned between the renal arteries 32
and 34 and the aneurysm 40. The collapsed prosthesis in accordance
with the present invention has a diameter in the range of about 2
to about 10 mm. Generally, the diameter of the collapsed prosthesis
is in the range of about 3 to 6 mm (12 to 18 French). Preferably,
the delivery catheter including the prosthesis will be 16 F, or 15
F or 14 F or smaller.
[0096] The prosthesis 88 is maintained in its collapsed
configuration by the restraining walls of the tubular delivery
catheter 80, such that removal of this restraint would allow the
prosthesis to self expand. Radiopaque marker material may be
incorporated into the delivery catheter 80, and/or the prosthesis
88, at least at both the proximal and distal ends, to facilitate
monitoring of prosthesis position. The dilator tip 82 is bonded to
an internal catheter core 92, as illustrated in FIG. 14, so that
the internal catheter core 92 and the partially expanded prosthesis
88 are revealed as the outer sheath of the delivery catheter 80 is
retracted.
[0097] As the outer sheath is retracted, the collapsed prosthesis
88 remains substantially fixed axially relative to the internal
catheter core 92 and consequently, self-expands at a predetermined
vascular site as illustrated in FIG. 14. Continued retraction of
the outer sheath results in complete deployment of the graft. After
deployment, the expanded endoluminal vascular prosthesis 88 has
radially self-expanded to a diameter anywhere in the range of about
20 to 40 mm, corresponding to expansion ratios of about 1:2 to
1:20. In a preferred embodiment, the expansion ratios range from
about 1:4 to 1:8, more preferably from about 1:4 to 1:6.
[0098] In addition to, or in place of, the outer sheath described
above, the prosthesis 88 may be maintained in its collapsed
configuration by a restraining lace, which may be woven through the
prosthesis or wrapped around the outside of the prosthesis in the
collapsed reduced diameter. Following placement of the prosthesis
at the treatment site, the lace can be proximally retracted from
the prosthesis thereby releasing it to self expand at the treatment
site. The lace may comprise any of a variety of materials, such as
sutures, strips of PTFE, FEP, polyester fiber, and others as will
be apparent to those of skill in the art in view of the disclosure
herein. The restraining lace may extend proximally through a lumen
in the delivery catheter or outside of the catheter to a proximal
control. The control may be a pull tab or ring, rotatable reel,
slider switch or other structure for permitting proximal retraction
of the lace. The lace may extend continuously throughout the length
of the catheter, or may be joined to another axially moveable
element such as a pull wire.
[0099] In general, the expanded diameter of the graft in accordance
with the present invention can be any diameter useful for the
intended lumen or hollow organ in which the graft is to be
deployed. For most arterial vascular applications, the expanded
size will be within the range of from about 10 to about 40 mm.
Abdominal aortic applications will generally require a graft having
an expanded diameter within the range of from about 20 to about 28
mm, and, for example, a graft on the order of about 45 mm may be
useful in the thoracic artery. The foregoing dimensions refer to
the expanded size of the graft in an unconstrained configuration,
such as on the table. In general, the graft will be positioned
within an artery having a slightly smaller interior cross-section
than the expanded size of the graft. This enables the graft to
maintain a slight positive pressure against the wall of the artery,
to assist in retention of the graft during the period of time prior
to endothelialization of the polymeric sleeve 44.
[0100] The radial force exerted by the proximal segment 94 of the
prosthesis against the walls of the aorta 30 provides a seal
against the leakage of blood around the vascular prosthesis and
tends to prevent axial migration of the deployed prosthesis. As
discussed above, this radial force can be modified as required
through manipulation of various design parameters, including the
axial length of the segment and the bend configurations. In another
embodiment of the present invention, radial tension can be enhanced
at the proximal, upstream end by increasing the wire gauge in the
proximal zone. Wire diameter may range from about 0.001 to 0.01
inches in the distal region to a range of from about 0.01 to 0.03
inches in the proximal region.
[0101] An alternative embodiment of the wire layout which would
cause the radial tension to progressively decrease from the
proximal segments to the distal segments, involves a progressive or
step-wise decrease in the wire gauge throughout the entire wire
support, from about 0.01 to 0.03 inches at the proximal end to
about 0.002 to 0.01 inches at the distal end. Such an embodiment,
may be used to create a tapered prosthesis. Alternatively, the wire
gauge may be thicker at both the proximal and distal ends, in order
to insure greater radial tension and thus, sealing capacity. Thus,
for instance, the wire gauge in the proximal and distal segments
may about 0.01 to 0.03 inches, whereas the intervening segments may
be constructed of thinner wire, in the range of about 0.001 to 0.01
inches.
[0102] Referring to FIG. 15, there is illustrated two alternative
deployment sites for the endoluminal vascular prosthesis 42 of the
present invention. For example, an aneurysm 33 is illustrated in
the right renal artery 32. An expanded endoluminal vascular
prosthesis 42, in accordance with the present invention, is
illustrated spanning that aneurysm 33. Similarly, an aneurysm 37 of
the right common iliac 36 is shown, with a prosthesis 42 deployed
to span the iliac aneurysm 37.
[0103] Referring to FIG. 16, there is illustrated a modified
embodiment of the endovascular prosthesis 96 in accordance with the
present invention. In the embodiment illustrated in FIG. 16, the
endovascular prosthesis 96 is provided with a wire cage 46 having
six axially aligned segments 54. As with the previous embodiments,
however, the endovascular prosthesis 96 may be provided with
anywhere from about 2 to about 10 or more axially spaced or
adjacent segments 54, depending upon the clinical performance
objectives of the particular embodiment.
[0104] The wire support 46 is provided with a tubular polymeric
sleeve 44 as has been discussed. In the present embodiment,
however, one or more lateral perfusion ports or openings are
provided in the polymeric sleeve 44, such as a right renal artery
perfusion port 98 and a left renal artery perfusion port 100 as
illustrated.
[0105] Perfusion ports in the polymeric sleeve 44 may be desirable
in embodiments of the endovascular prosthesis 96 in a variety of
clinical contexts. For example, although FIGS. 1 and 16 illustrate
a generally symmetrical aneurysm 40 positioned within a linear
infrarenal portion of the abdominal aorta, spaced axially apart
both from bilaterally symmetrical right and left renal arteries and
bilaterally symmetrical right and left common iliacs, both the
position and symmetry of the aneurysm 40 as well as the layout of
the abdominal aortic architecture may differ significantly from
patient to patient. As a consequence, the endovascular prosthesis
96 may need to extend across one or both of the renal arteries in
order to adequately anchor the endovascular prosthesis 96 and/or
span the aneurysm 40. The provision of one or more lateral
perfusion ports or zones enables the endovascular prosthesis 96 to
span the renal arteries while permitting perfusion therethrough,
thereby preventing "stentjailing" of the renals. Lateral perfusion
through the endovascular prosthesis 96 may also be provided, if
desired, for a variety of other arteries including the second
lumbar, testicular, inferior mesenteric, middle sacral, and alike
as will be well understood to those of skill in the art.
[0106] The endovascular prosthesis 96 is preferably provided with
at least one, and preferably two or more radiopaque markers, to
facilitate proper positioning of the prosthesis 96 within the
artery. In an embodiment having perfusion ports 98 and 100 such as
in the illustrated design, the prosthesis 96 should be properly
aligned both axially and rotationally, thereby requiring the
ability to visualize both the axial and rotational position of the
device. Alternatively, provided that the delivery catheter design
exhibits sufficient torque transmission, the rotational orientation
of the graft may be coordinated with an indexed marker on the
proximal end of the catheter, so that the catheter may be rotated
and determined by an external indicium of rotational orientation to
be appropriately aligned with the right and left renal
arteries.
[0107] In an alternative embodiment, the polymeric sleeve 44
extends across the aneurysm 40, but terminates in the infrarenal
zone. In this embodiment, a proximal zone 55 on the prosthesis 96
comprises a wire cage 46 but no polymeric sleeve 44. In this
embodiment, the prosthesis 96 still accomplishes the anchoring
function across the renal arteries, yet does not materially
interfere with renal perfusion. Thus, the polymeric sleeve 44 may
cover anywhere from about 50% to about 100% of the axial length of
the prosthesis 96 depending upon the desired length of uncovered
wire cage 46 such as for anchoring and/or lateral perfusion
purposes. In particular embodiments, the polymeric sleeve 44 may
cover within the range of from about 70% to about 80%, and, in one
four segment embodiment having a single exposed segment, 75%, of
the overall length of the prosthesis 96. The uncovered wire cage 46
may reside at only a single end of the prosthesis 96, such as for
traversing the renal arteries. Alternatively, exposed portions of
the wire cage 46 may be provided at both ends of the prosthesis
such as for anchoring purposes.
[0108] In a further alternative, a two part polymeric sleeve 44 is
provided. A first distal part spans the aneurysm 40, and has a
proximal end which terminates distally of the renal arteries. A
second, proximal part of the polymeric sleeve 44 is carried by the
proximal portion of the wire cage 46 which is positioned superiorly
of the renal arteries. This leaves an annular lateral flow path
through the side wall of the vascular prosthesis 96, which can be
axially aligned with the renal arteries, without regard to
rotational orientation.
[0109] The axial length of the gap between the proximal and distal
segments of polymeric sleeve 44 can be adjusted, depending upon the
anticipated cross-sectional size of the ostium of the renal artery,
as well as the potential axial misalignment between the right and
left renal arteries. Although the right renal artery 32 and left
renal artery 34 are illustrated in FIG. 16 as being concentrically
disposed on opposite sides of the abdominal aorta, the take off
point for the right or left renal arteries from the abdominal aorta
may be spaced apart along the abdominal aorta as will be familiar
to those of skill in the art. In general, the diameter of the
ostium of the renal artery measured in the axial direction along
the abdominal aorta falls within the range of from about 7 mm to
about 20 mm for a typical adult patient.
[0110] Prior art procedures presently use a 7 mm introducer (18
French) which involves a surgical procedure for introduction of the
graft delivery device. Embodiments of the present invention can be
constructed having a 16 French or 15 French or 14 French or smaller
profile (e.g. 3-4 mm) thereby enabling placement of the endoluminal
vascular prosthesis of the present invention by way of a
percutaneous procedure. In addition, the endoluminal vascular
prosthesis of the present invention does not require a post
implantation balloon dilatation, can be constructed to have minimal
axial shrinkage upon radial expansion.
[0111] Referring to FIG. 17, there is disclosed a schematic
representation of the abdominal part of the aorta and its principal
branches as in FIG. 1. An expanded bifurcated endoluminal vascular
prosthesis 102, in accordance with the present invention, is
illustrated spanning the aneurysms 103, 104 and 105. The
endoluminal vascular prosthesis 102 includes a polymeric sleeve 106
and a tubular wire support 107, which are illustrated in situ in
FIG. 17. The sleeve 106 and wire support 107 are more readily
visualized in the exploded view shown in FIG. 19. The endoluminal
prosthesis 102 illustrated and described herein depicts an
embodiment in which the polymeric sleeve 106 is situated
concentrically outside of the tubular wire support 107. However,
other embodiments may include a sleeve situated instead
concentrically inside the wire support or on both of the inside and
the outside of the wire support. Alternatively, the wire support
may be embedded within a polymeric matrix which makes up the
sleeve. Regardless of whether the sleeve 106 is inside or outside
the wire support 107, the sleeve may be attached to the wire
support by any of a variety of means, as has been previously
discussed.
[0112] The tubular wire support 107 comprises a primary component
108 for traversing the aorta and a first iliac, and a branch
component 109 for extending into the second iliac. The primary
component 108 may be formed from a continuous single length of
wire, throughout both the aorta trunk portion and the iliac branch
portion. See FIGS. 19 and 20. Alternatively, each iliac branch
component can be formed separately from the aorta trunk portion.
Construction of the graft from a three part cage conveniently
facilitates the use of different gauge wire in the different
components (e.g. 14 gauge main trunk and 10 gauge branch
components).
[0113] The wire support 107 is preferably formed in a plurality of
discrete segments, connected together and oriented about a common
axis. In FIG. 20, Section A corresponds to the aorta trunk portion
of the primary component 108, and includes segments 1-5. Segments
6-8 (Section B) correspond to the iliac branch portion of the
primary component 108.
[0114] In general, each of the components of the tubular wire
support 107 can be varied considerably in diameter, length, and
expansion coefficient, depending upon the intended application. For
implantation within a typical adult, the aorta trunk portion
(section A) of primary component 108 will have a length within the
range of from about 5 cm to about 12 cm, and, typically within the
range of from about 9 cm to about 10 cm. The unconstrained outside
expanded diameter of the section A portion of the primary component
108 will typically be within the range of from about 20 mm to about
40 mm. The unconstrained expanded outside diameter of the section A
portion of primary component 108 can be constant or substantially
constant throughout the length of section A, or can be tapered from
a relatively larger diameter at the proximal end to a relatively
smaller diameter at the bifurcation. In general, the diameter of
the distal end of section A will be on the order of no more than
about 95% and, preferably, no more than about 85% of the diameter
of the proximal end of section A.
[0115] The right and left iliac portions, corresponding to section
B on primary component 108 and section C will typically be
bilaterally symmetrical. Section C length will generally be within
the range of from about 1 cm to about 5 cm, and section C diameter
will typically be within the range of from about 10 mm to about 20
mm.
[0116] Referring to FIG. 19, the wire cage 107 is dividable into a
proximal zone 110, a central zone 111 and a distal zone 112. As has
been discussed, the wire cage 107 can be configured to taper from a
relatively larger diameter in the proximal zone 110 to a relatively
smaller diameter in the distal zone 112. In addition, the wire cage
107 can have a transitional tapered and or stepped diameter within
a given zone.
[0117] Referring to FIG. 20, there is illustrated a plan view of
the single formed wire used for rolling about a longitudinal axis
to produce a primary segment 108 having a five segment aorta
section and a three segment iliac section. The formed wire exhibits
distinct segments, each corresponding to an individual tubular
segment in the tubular support. Additional details of the wire cage
layout and construction can be found in copending U.S. patent
application Ser. No. 09/034,689 entitled Endoluminal Vascular
Prosthesis, filed March 4, 1998, the disclosure of which is
incorporated in its entirety herein by reference.
[0118] Each segment has a repeating pattern of proximal bends 60
connected to corresponding distal bends 62 by wall sections 64
which extend in a generally zig-zag configuration when the segment
is radially expanded, as has been discussed in connection with FIG.
3. Each segment is connected to the adjacent segment through a
connector 66, and one or more links 70 as has been discussed in
connection with FIGS. 5-12. The connector 66 in the illustrated
embodiment comprises two wall sections 64 which connect a proximal
bend 60 on a first segment with a distal bend 62 on a second,
adjacent segment. The connector 66 may additionally be provided
with a connector bend 68, which may be used to impart increased
radial strength to the graft and/or provide a tie site for a
circumferentially extending suture.
[0119] In the illustrated embodiment, section A is intended for
deployment within the aorta whereas section B is intended to be
deployed within a first iliac. Thus, section B will preferably have
a smaller expanded diameter than section A. This may be
accomplished by providing fewer proximal and distal bends 60, 62
per segment in section B or in other manners as will be apparent to
those of skill in the art in view of the disclosure herein. In the
illustrated embodiment, section B has one fewer proximal bend 60
per segment than does each segment in section A. This facilitates
wrapping of the wire into a tubular prosthesis cage such as that
illustrated in FIG. 19, so that the iliac branch has a smaller
diameter than the aorta branch. At the bifurcation, an opening
remains for connection of the second iliac branch. The second
branch is preferably formed from a section of wire in accordance
with the general principles discussed above, and in a manner that
produces a similarly dimensioned wire cage as that produced by
section B. The second iliac branch (section C) may be attached at
the bifurcation to section A and/or section B in any of a variety
of manners, to provide a secure junction therebetween. In one
embodiment, one or two of the proximal bends 60 on section C will
be secured to the corresponding distal bends 62 on the distal most
segment of section A. Attachment may be accomplished such as
through the use of a circumferentially threaded suture, through
links 70 as has been discussed previously, through soldering or
other attachment means. The attachment means will be influenced by
the desirable flexibility of the graft at the bifurcation, which
will in turn be influenced by the method of deployment of the
vascular graft as will be apparent to those of skill in the art in
view of the disclosure herein.
[0120] Referring to FIG. 21, there is disclosed an exploded
schematic representation of a hinged or articulated variation in
the tubular wire support structure for a bifurcated graft in
accordance with present invention. The tubular wire support
comprises a main body, or aortic trunk portion 200 and right 202
and left 204 iliac branch portions. Right and left designations
correspond to the anatomic designations of right and left common
iliac arteries. The proximal end 206 of the aortic trunk portion
200 has apexes 211-216 adapted for connection with the
complementary apexes on the distal ends 208 and 210 of the right
202 and left 204 iliac branch portions, respectively. Complementary
pairing of apexes is indicated by the shared numbers, wherein the
right branch portion apexes are designated by (R) and the left
branch portion apexes are designated by (L). Each of the portions
may be formed from a continuous single length of wire. See FIG.
23.
[0121] Referring to FIG. 22, the assembled articulated wire support
structure is shown. The central or medial apex 213 in the
foreground (anterior) of the aortic trunk portion 200 is linked
with 213(R) on the right iliac portion 202 and 213(L) on the left
iliac portion 204. Similarly, the central apex 214 in the
background (posterior) is linked with 214(R) on the right iliac
portion 202 and 214(L) on the left iliac portion 204. Each of these
linkages has two iliac apexes joined with one aortic branch apex.
The linkage configurations may be of any of the variety described
above in FIG. 7A-D. The medial most apexes 218 (R) and (L) of the
iliac branch portions 202 and 204 are linked together, without
direct connection with the aortic truck portion 200.
[0122] The medial apexes 213 and 214 function as pivot points about
which the right and left iliac branches 202, 204 can pivot to
accommodate unique anatomies. Although the right and left iliac
branches 202, 204 are illustrated at an angle of about 45.degree.
to each other, they are articulable through at least an angle of
about 90.degree. and preferably at least about 120.degree.. The
illustrated embodiment allows articulation through about
180.degree. while maintaining patency of the central lumen. To
further improve patency at high iliac angles, the apexes 213 and
214 can be displaced proximally from the transverse plane which
roughly contains apexes 211, 212, 215 and 216 by a minor adjustment
to the fixture about which the wire is formed. Advancing the pivot
point proximally relative to the lateral apexes (e.g., 211, 216)
opens the unbiased angle between the iliac branches 202 and
204.
[0123] In the illustrated embodiment, the pivot point is formed by
a moveable link between an eye on apex 213 and two apexes 213R and
213L folded therethrough. To accommodate the two iliac apexes 213R
and 213L, the diameter of the eye at apex 213 may be slightly
larger than the diameter of the eye on other apexes throughout the
graft. Thus, for example, the diameter of the eye at apex 213 in
one embodiment made from 0.014" diameter wire is about 0.059",
compared to a diameter of about 0.020" for eyes elsewhere in the
graft.
[0124] Although the pivot points (apexes 213, 214) in the
illustrated embodiment are on the medial plane, they may be moved
laterally such as, for example, to the axis of each of the iliac
branches. In this variation, each iliac branch will have an
anterior and a posterior pivot link on or about its longitudinal
axis, for a total of four unique pivot links at the bifurcation.
Alternatively, the pivot points can be moved as far as to lateral
apexes 211 and 216. Other variations will be apparent to those of
skill in the art in view of the disclosure herein.
[0125] To facilitate lateral rotation of the iliac branches 202,
204 about the pivot points and away from the longitudinal axis of
the aorta trunk portion 200 of the graft, the remaining links
between the aorta trunk portion 200 and the iliac branches 202, 204
preferably permit axial compression and expansion. In general, at
least one and preferably several links lateral to the pivot point
in the illustrated embodiment permit axial compression or
shortening of the graft to accommodate lateral pivoting of the
iliac branch. If the pivot point is moved laterally from the
longitudinal axis of the aorta portion of the graft, any links
medial of the pivot point preferably permit axial elongation to
accommodate lateral rotation of the branch. In this manner, the
desired range of rotation of the iliac branches may be accomplished
with minimal deformation of the wire, and with patency of the graft
optimized throughout the angular range of motion.
[0126] To permit axial compression substantially without
deformation of the wire, the lateral linkages, 211 and 212 for the
right iliac, and 215 and 216 for the left iliac, may be different
from the previously described apex-to-apex linkage configurations.
The lateral linkages are preferably slidable linkages, wherein a
loop formed at the distal end of the iliac apex slidably engages a
strut of the corresponding aortic truck portion. The loop and strut
orientation may be reversed, as will be apparent to those of skill
in the art. Interlocking "elbows" without any distinct loop may
also be used. Such an axially compressible linkage on the lateral
margins of the assembled wire support structure allow the iliac
branch portions much greater lateral flexibility, thereby
facilitating placement in patients who often exhibit a variety of
iliac branch asymmetries and different angles of divergence from
the aortic trunk.
[0127] Referring to FIG. 23, there is illustrated a plan view of a
single formed wire used for rolling about a longitudinal axis to
produce a four segment straight tubular wire support for an iliac
limb. The formed wire exhibits distinct segments, each
corresponding to an individual tubular segment in the tubular
supports 202 or 204 (See FIG. 21). The distal segment I, is adapted
to articulate with the aortic trunk portion 200 and the adjacent
iliac limb portion. The distal segment (I) has two apexes (e.g.
corresponding to 211 and 212 on the right iliac portion 202 in FIG.
21) which form a loop adapted to slidably engage a strut in the
lateral wall of the aortic portion. These articulating loops (A)
are enlarged in FIG. 24A. As discussed above, the loops are
preferably looped around a strut on the corresponding apex of the
proximal aortic segment to provide a sliding linkage.
[0128] The apex 218 is proximally displaced relative to the other
four apexes in the distal segment (I). Apex 218 (R or L) is
designed to link with the complementary 218 apex on the other iliac
branch portion (See FIG. 22). The apex 218 in the illustrated
embodiment is formed adjacent or near an intersegment connector 66,
which extends proximally from the distal segment.
[0129] The other apexes on the distal segment (I) of an iliac limb
are designed to link with a loop on the corresponding apex of the
proximal aortic segment. Because many variations of this linkage
are consistent with the present invention (See FIGS. 7A-D), the
form of the corresponding apexes may vary. In a preferred
variation, the apexes (B) form a narrow U-shape, having an inside
diameter of about 0.019 inches in an embodiment made from 0.012
inch Conichrome wire (tensile strength 300 ksi minimum) as
illustrated in FIG. 24B. The U-shaped, elongated axial portion of
the apex shown in FIG. 24B permits the apex to be wrapped through
and around a corresponding loop apex of the proximal aortic
segment. This type of linkage is discussed in greater detail above
in connection with FIGS. 5 and 6.
[0130] In more general terms, the wire support illustrated in FIGS.
21 and 22 comprises a main body support structure formed from one
or more lengths of wire and having a proximal end, a distal end and
a central lumen extending along a longitudinal axis. The wire
support also comprises a first branch support structure formed from
one or more lengths of wire and having a proximal end, a distal end
and a central lumen therethrough. The first branch support
structure is pivotably connected to the proximal end of the main
body support structure. The tubular wire support further comprises
a second branch support structure formed from one or more lengths
of wire and having a proximal end, a distal end and a central lumen
extending therethrough. The distal end of the second branch support
structure is pivotably connected to the proximal end of the main
body support structure.
[0131] Further, the distal ends of the first and second branch
structures may be joined together by a flexible linkage, formed for
example between apexes 218(R) and 218(L) in FIG. 21. By
incorporating a medial linkage between the two branch support
structures and pivotable linkages with the main trunk, the first
and second branch support structures can hinge laterally outward
from the longitudinal axis without compromising the volume of the
lumen. Thus, the branches may enjoy a wide range of lateral
movement, thereby accommodating a variety of patient and vessel
heterogeneity. Additional corresponding apexes between the main
trunk and each iliac branch may also be connected, or may be free
floating within the outer polymeric sleeve. Axially compressible
lateral linkages, discussed above and illustrated in FIG. 22, may
optionally be added.
[0132] The proximal apexes (C) of the iliac limb portions are
adapted to link with the distal apexes of the next segment. These
proximal apexes preferably form loops, such as those illustrated in
FIG. 24C, wherein the elongated axial portions of the corresponding
proximal apex in the adjacent segment can wrap around the loop,
thereby providing flexibility of the graft, as discussed above for
FIGS. 5 and 6.
[0133] The wire may be made from any of a variety of different
alloys and wire diameters or non-round cross-sections, as has been
discussed. In one embodiment of the bifurcation graft, the wire
gauge remains substantially constant throughout section A of the
primary component 49 and steps down to a second, smaller
cross-section throughout section B of primary component 108.
[0134] A wire diameter of approximately 0.018 inches may be useful
in the aorta trunk portion of a graft having five segments each
having 2.0 cm length per segment, each segment having six struts
intended for use in the aorta, while a smaller diameter such as
0.012 inches might be useful for segments of the graft having 6
struts per segment intended for the iliac artery.
[0135] In one embodiment of the present invention, the wire
diameter may be tapered throughout from the proximal to distal ends
of the section A and/or section B portions of the primary component
108. Alternatively, the wire diameter may be tapered incremental or
stepped down, or stepped up, depending on the radial strength
requirements of each particular clinical application. In one
embodiment, intended for the abdominal aortic artery, the wire has
a cross-section of about 0.018 inches in the proximal zone 110 and
the wire tapers down regularly or in one or more steps to a
diameter of about 0.012 inches in the distal zone 112 of the graft
102. End point dimensions and rates of taper can be varied widely,
within the spirit of the present invention, depending upon the
desired clinical performance.
[0136] In general, in the tapered or stepped wire embodiments, the
diameter of the wire in the iliac branches is no more than about
80% of the diameter of the wire in the aortic trunk. This permits
increased flexibility of the graft in the region of the iliac
branches, which has been determined by the present inventors to be
clinically desirable.
[0137] The collapsed prosthesis in accordance with the present
invention has a diameter in the range of about 2 to about 10 mm.
Preferably, the maximum diameter of the collapsed prosthesis is in
the range of about 3 to 6 mm (12 to 18 French). Some embodiments of
the delivery catheter including the prosthesis will be in the range
of from 18 to 20 or 21 French; other embodiments will be as low as
19 F, 16 F, 14 F, or smaller. After deployment, the expanded
endoluminal vascular prosthesis has radially self-expanded to a
diameter anywhere in the range of about 20 to 40 mm, corresponding
to expansion ratios of about 1:2 to 1:20. In a preferred
embodiment, the expansion ratios range from about 1:4 to 1:8, more
preferably from about 1:4 to 1:6.
[0138] The self expandable bifurcation graft of the present
invention can be deployed at a treatment site in accordance with
any of a variety of techniques as will be apparent to those of
skill in the art. One such technique is disclosed in copending
patent application Ser. No. 08/802,478 entitled Bifurcated Vascular
Graft and Method and Apparatus for Deploying Same, filed Feb. 20,
1997, the disclosure of which is incorporated in its entirety
herein by reference.
[0139] A partial cross-sectional side elevational view of one
deployment apparatus 120 in accordance with the present invention
is shown in FIG. 25. The deployment apparatus 120 comprises an
elongate flexible multicomponent tubular body 122 having a proximal
end 124 and a distal end 126. The tubular body 122 and other
components of this system can be manufactured in accordance with
any of a variety of techniques well known in the catheter
manufacturing field. Suitable materials and dimensions can be
readily selected taking into account the natural anatomical
dimensions in the iliacs and aorta, together with the dimensions of
the desired percutaneous access site.
[0140] The elongate flexible tubular body 122 comprises an outer
sheath 128 which is axially movably positioned upon an intermediate
tube 130. A central tubular core 132 is axially movably positioned
within the intermediate tube 130. In one embodiment, the outer
tubular sheath comprises extruded PTFE, having an outside diameter
of about 0.250" and an inside diameter of about 0.230". The tubular
sheath 128 is provided at its proximal end with a manifold 134,
having a hemostatic valve 136 thereon and access ports such as for
the infusion of drugs or contrast media as will be understood by
those of skill in the art.
[0141] The outer tubular sheath 128 has an axial length within the
range of from about 40" to about 55", and, in one embodiment of the
deployment device 120 having an overall length of 110 cm, the axial
length of the outer tubular sheath 128 is about 52 cm and the
outside diameter is no more than about 0.250". Thus, the distal end
of the tubular sheath 128 is located at least about 16 cm
proximally of the distal end 126 of the deployment catheter 120 in
stent loaded configuration.
[0142] As can be seen from FIGS. 26 and 27-28, proximal retraction
of the outer sheath 128 with respect to the intermediate tube 130
will expose the compressed iliac branches of the graft, as will be
discussed in more detail below.
[0143] A distal segment of the deployment catheter 120 comprises an
outer tubular housing 138, which terminates distally in an elongate
flexible tapered distal tip 140. The distal housing 138 and tip 140
are axially immovably connected to the central core 132 at a
connection 142.
[0144] The distal tip 140 preferably tapers from an outside
diameter of about 0.225" at its proximal end to an outside diameter
of about 0.070" at the distal end thereof. The overall length of
the distal tip 140 in one embodiment of the deployment catheter 120
is about 3". However, the length and rate of taper of the distal
tip 140 can be varied depending upon the desired trackability and
flexibility characteristics. The distal end of the housing 138 is
secured to the proximal end of the distal tip 140 such as by
thermal bonding, adhesive bonding, and/or any of a variety of other
securing techniques known in the art. The proximal end of distal
tip 140 is preferably also directly or indirectly connected to the
central core 132 such as by a friction fit and/or adhesive
bonding.
[0145] In at least the distal section of the catheter, the central
core 132 preferably comprises a length of hypodermic needle tubing.
The hypodermic needle tubing may extend throughout the length
catheter to the proximal end thereof, or may be secured to the
distal end of a proximal extrusion as illustrated for example in
FIG. 22. A central guide, ire lumen 144 extends throughout the
length of the tubular central core 132, having a distal exit port
146 and a proximal access port 148 as will be understood by those
of skill in the art.
[0146] Referring to FIGS. 26-28, a bifurcated endoluminal graft 150
is illustrated in a compressed configuration within the deployment
catheter 120. The graft 150 comprises a distal aortic section 152,
a proximal ipsilateral iliac portion 154, and a proximal
contralateral iliac portion 156. The aortic trunk portion 152 of
the graft 150 is contained within the tubular housing 138. Distal
axial advancement of the central tubular core 132 will cause the
distal tip 140 and housing 138 to advance distally with respect to
the graft 150, thereby permitting the aortic trunk portion 152 of
the graft 150 to expand to its larger, unconstrained diameter.
Distal travel of the graft 150 is prevented by a distal stop 158
which is axially immovably connected to the intermediate tube 130.
Distal stop 158 may comprise any of a variety of structures, such
as an annular flange or component which is adhered to, bonded to or
integrally formed with a tubular extension 160 of the intermediate
tube 132. Tubular extension 160 is axially movably positioned over
the hypotube central core 132.
[0147] The tubular extension 160 extends axially throughout the
length of the graft 150. At the proximal end of the graft 150, a
step 159 axially immovably connects the tubular extension 160 to
the intermediate tube 130. In addition, the step 159 provides a
proximal stop surface to prevent proximal travel of the graft 150
on the catheter 120. The function of step 159 can be accomplished
through any of a variety of structures as will be apparent to those
of skill in the art in view of the disclosure herein. For example,
the step 159 may comprise an annular ring or spacer which receives
the tubular extension 160 at a central aperture therethrough, and
fits within the distal end of the intermediate tube 130.
Alternatively, the intermediate tube 130 can be reduced in diameter
through a generally conical section or shoulder to the diameter of
tubular extension 160.
[0148] Proximal retraction of the outer sheath 128 will release the
iliac branches 154 and 156 of the graft 150. The iliac branches 154
and 156 will remain compressed, within a first (ipsilateral)
tubular sheath 162 and a second (contralateral) tubular sheath 164.
The first tubular sheath 162 is configured to restrain the
ipsilateral branch of the graft 150 in the constrained
configuration, for implantation at the treatment site. The first
tubular sheath 162 is adapted to be axially proximally removed from
the iliac branch, thereby permitting the branch to expand to its
implanted configuration. In one embodiment, the first tubular
sheath 162 comprises a thin walled PTFE extrusion having an outside
diameter of about 0.215" and an axial length of about 7.5 cm. A
proximal end of the tubular sheath 162 is necked down such as by
heat shrinking to secure the first tubular sheath 162 to the
tubular extension 160. In this manner, proximal withdrawal of the
intermediate tube 130 will in turn proximally advance the first
tubular sheath 162 relative to the graft 150, thereby deploying the
self expandable iliac branch of the graft 150.
[0149] The second tubular sheath 164 is secured to the
contralateral guidewire 166, which extends outside of the tubular
body 122 at a point 168, such as may be conveniently provided at
the junction between the outer tubular sheath 128 and the distal
housing 138. The second tubular sheath 164 is adapted to restrain
the contralateral branch of the graft 150 in the reduced profile.
In one embodiment of the invention, the second tubular sheath 164
has an outside diameter of about 0.215" and an axial length of
about 7.5 cm. The second tubular sheath 164 can have a
significantly smaller cross-section than the first tubular sheath
162, due to the presence of the tubular core 132 and intermediate
tube 130 within the first iliac branch 154.
[0150] The second tubular sheath 164 is secured at its proximal end
to a distal end of the contralateral guidewire 166. This may be
accomplished through any of a variety of securing techniques, such
as heat shrinking, adhesives, mechanical interfit and the like. In
one embodiment, the guidewire is provided with a knot or other
diameter enlarging structure to provide an interference fit with
the proximal end of the second tubular sheath 156, and the proximal
end of the second tubular sheath 156 is heat shrunk and/or bonded
in the area of the knot to provide a secure connection. Any of a
variety of other techniques for providing a secure connection
between the contralateral guidewire 166 and tubular sheath 156 can
readily be used in the context of the present invention as will be
apparent to those of skill in the art in view of the disclosure
herein. The contralateral guidewire 166 can comprise any of a
variety of structures, including polymeric monofilament materials,
braided or woven materials, metal ribbon or wire, or conventional
guidewires as are well known in the art.
[0151] In use, the free end of the contralateral guidewire 166 is
percutaneously inserted into the arterial system, such as at a
first puncture in a femoral artery. The contralateral guidewire is
advanced through the corresponding iliac towards the aorta, and
crossed over into the contralateral iliac in accordance with cross
over techniques which are well known in the art. The contralateral
guidewire is then advanced distally down the contralateral iliac
where it exits the body at a second percutaneous puncture site.
[0152] The deployment catheter 120 is thereafter percutaneously
inserted into the first puncture, and advanced along a guidewire
(e.g. 0.035 inch) through the ipsilateral iliac and into the aorta.
As the deployment catheter 120 is transluminally advanced, slack
produced in the contralateral guidewire 166 is taken up by
proximally withdrawing the guidewire 166 from the second
percutaneous access site. In this manner, the deployment catheter
120 is positioned in the manner generally illustrated in FIG. 29.
Referring to FIG. 30, the outer sheath 128 is proximally withdrawn
while maintaining the axial position of the overall deployment
catheter 120, thereby releasing the first and second iliac branches
of the graft 150. Proximal advancement of the deployment catheter
120 and contralateral guidewire 166 can then be accomplished, to
position the iliac branches of the graft 150 within the iliac
arteries as illustrated.
[0153] Referring to FIG. 31, the central core 132 is distally
advanced thereby distally advancing the distal housing 138 as has
been discussed. This exposes the aortic trunk of the graft 150,
which deploys into its fully expanded configuration within the
aorta. As illustrated in FIG. 32, the contralateral guidewire 166
is thereafter proximally withdrawn, thereby by proximally
withdrawing the second sheath 164 from the contralateral iliac
branch 156 of the graft 150. The contralateral branch 156 of the
graft 150 thereafter self expands to fit within the iliac artery.
The guidewire 166 and sheath 164 may thereafter be proximally
withdrawn and removed from the patient, by way of the second
percutaneous access site.
[0154] Thereafter, the deployment catheter 120 may be proximally
withdrawn to release the ipsilateral branch 154 of the graft 150
from the first tubular sheath 162 as shown in FIG. 33. Following
deployment of the ipsilateral branch 154 of the prosthesis 150, a
central lumen through the aortic trunk 152 and ipsilateral branch
154 is sufficiently large to permit proximal retraction of the
deployment catheter 120 through the deployed bifurcated graft 150.
The deployment catheter 120 may thereafter be proximally withdrawn
from the patient by way of the first percutaneous access site.
[0155] Referring to FIGS. 34a-34c, there is illustrated a flexible,
straight graft design in accordance with a further aspect of the
present invention. In this configuration, the wire cage may be
flexed around a bend by allowing axial compression on an inside
radius 227 compared to an outside radius 229, as seen in FIG. 34c.
Axial compression on the inside radius 227 is enabled by the
provision of a plurality of sliding links 220, one embodiment of
which is illustrated in FIG. 34b. In general, the sliding link 220
enables the connection between a proximal bend 60 and a
corresponding distal bend 62 to be compressible in the axial
direction while maintaining the radial strength and radial
expandibility of the graft.
[0156] In the illustrated embodiment, this is accomplished by
looping the proximal bend 60 around a wall section 64 which extends
between a distal bend 62 and proximal bend 60 on a proximally
adjacent segment of the graft. The proximal bend 60 is formed into
a closed loop to form an aperture 61 for slidably entrapping the
corresponding wall section 64. As used herein, the designations
"proximal" and "distal" may be interchangeable when used, for
example, to describe the relative position of the complementary
sliding link structures on a graft. In addition, the proximal and
distal designations are used sometimes herein with respect to the
deployment catheter or deployment catheter direction, and other
times in their anatomical sense with respect to the heart. The
particular usage of these terms will be apparent to those of skill
in the art in the context in which they are used herein.
[0157] Thus, referring to FIG. 34a, there is disclosed a flexible
straight graft having a proximal end 50, and a distal end 52. The
graft comprises a plurality of segments, such as a first segment
230, a second segment 232, a third segment 234, and a fourth
segment 236. The adjacent segments can be formed separately or
formed integrally such as from a single length of wire. All of the
dimensions, materials and other design specifications which have
been disclosed previously herein may be provided with the sliding
link design, and will therefore not be repeated. In general,
however, the sliding link 220 is preferably provided on each of the
connections between any two adjacent segments in a graft at which
flexibility is desired, to permit the desired flexibility of the
graft. For example, each of the connections between first segment
230 and second segment 232 may be provided with a sliding link 220.
The connections between the intermediate segments 232 and 234 may
be provided with either sliding links 220 or nonsliding links as
have been disclosed elsewhere herein. The connections between the
third segment 234 and fourth segment 236 may be provided with
sliding links 220.
[0158] Referring to FIGS. 35a-35d, there is illustrated an
embodiment of a bifurcation graft of the present invention in which
sliding links 220 are utilized to increase the lateral flexibility
of the proximal and distal ends of the graft, while axially
noncompressible links are utilized for the central trunk of the
graft. Referring to FIG. 35a, the bifurcation graft extends between
a proximal end 50 and a distal end 52. In a proximal zone 55, which
may comprise two or three or more adjacent segments, the
connections between each proximal bend 60 and corresponding distal
bend 62 is in the form of a sliding link 220. See FIG. 35b.
[0159] Throughout an intermediate zone 57, which may comprise the
third, fourth, and fifth segments of the aortic trunk portion of
the graft, axially noncompressible links are provided such as those
disclosed elsewhere herein. See FIG. 35c.
[0160] The distal zone 59 of the graft, which, in the context of a
bifurcation graft, includes a portion or all of the right and left
iliac branches, comprises sliding links 220. See FIG. 35d. This
assembly allows the maintenance of a certain axial (column
strength) integrity while permitting the proximal end 50 and distal
end 52 to adapt to curved or otherwise unusual anatomy. Sliding
links 220 may alternatively be used throughout the length of the
graft, or only at the connection of the proximal-most segment
and/or the distal-most segment of the graft.
[0161] Referring to FIG. 36, there is illustrated a tapered graft
design. This design is illustrated in the context of a bifurcation
graft, although it can be readily adapted for use on a straight
segment graft such as that illustrated in FIG. 1. It may be readily
applied to any of the bifurcation grafts disclosed herein,
including, for example, those of FIGS. 17-22.
[0162] In the illustrated embodiment, an aortic trunk 222 is
connected to or formed with a right iliac branch 224 and a left
iliac branch 226. At least a portion of the aortic trunk 222 is
tapered from a larger unconstrained expanded diameter at the
proximal end 50 to a smaller unconstrained expanded diameter at the
bifurcation into right iliac 224 and left iliac 226. Although FIG.
36 illustrates a relatively uniform taper throughout the length of
the aortic trunk portion 222, a nonuniform taper may also be
utilized. For example, the first segment 230 and second segment 232
may be provided with a taper while the third segment 234, fourth
segment, and fifth segment 238 may be relatively nontapered. Any of
a wide variety of alternate configurations may be devised,
depending upon the desired clinical performance and intended
anatomy.
[0163] In the illustrated embodiment, the first segment 230 is
provided with 10 proximal bends 60. The fifth segment 238 is
provided with six proximal bends 60. By successively reducing the
number of proximal bends 60 (and thus the number of zig-zag
components to each segment), the tapered design can be achieved.
The reduction in proximal bends 60, and thus diameter of the aortic
trunk portion 222, from the first segment 230 to the fifth or other
last segment 238 may be such that the number of proximal bends 60
in the last segment 238 is anywhere from about 40% to about 100% of
the number of proximal bends 60 in the first segment 230. In some
embodiments, the last segment 238 has anywhere from about 50% to
about 80% and, in certain embodiments, about 60% of the number of
proximal bends 60 in the first segment 230.
[0164] The foregoing structure may be provided in any of a variety
of expanded diameters. In general, for an abdominal aortic aneurysm
at the bifurcation of the iliacs, the maximum expanded diameter of
the first segment 230 is preferably at least about 25 mm, and in
many embodiments, at least about 30 mm. In one embodiment, the
expanded diameter of the first segment 230 is at least about 34 mm.
The expanded diameter of the graft at the bifurcation is generally
within the range of from about 22 mm to about 28 mm, and, in one
embodiment, is no more than about 25 mm.
[0165] In an alternate embodiment, the tapered expanded diameter
configuration may be achieved by shaping the PTFE graft into a
tapered configuration which constrains expansion of the wire cage.
In this embodiment, each segment of the wire cage may have the same
number of proximal bends 60. However, the constraint imposed by the
PTFE sleeve may produce an unnecessary and potentially undesirable
bunching of the zig-zag portions of the wire frame, particularly in
the area of the last segment 238.
[0166] While a number of preferred embodiments of the invention and
variations thereof have been described in detail, other
modifications and methods of using and medical applications for the
same will be apparent to those of skill in the art. Accordingly, it
should be understood that various applications, modifications, and
substitutions may be made of equivalents without departing from the
spirit of the invention or the scope of the claims.
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