U.S. patent application number 11/906703 was filed with the patent office on 2009-05-28 for expandable supportive branched endoluminal grafts.
Invention is credited to Rysler Alcime, Yasushi Kato, Leonard Pinchuk.
Application Number | 20090138067 11/906703 |
Document ID | / |
Family ID | 24227879 |
Filed Date | 2009-05-28 |
United States Patent
Application |
20090138067 |
Kind Code |
A1 |
Pinchuk; Leonard ; et
al. |
May 28, 2009 |
Expandable supportive branched endoluminal grafts
Abstract
An endoluminal graft which is both expandable and supportive is
provided in a form suitable for use in a branched body vessel
location. The graft expands between a first diameter and a second,
larger diameter. The support component is an expandable stent
endoprosthesis. A liner is applied to the endoprosthesis in the
form of a compliant wall material that is porous and biocompatible
in order to allow normal cellular invasion upon implantation,
without stenosis, when the expandable and supportive graft is at
its second diameter. The supportive endoluminal graft is preferably
provided as a plurality of components that are deployed separately
at the branching body vessel location, one of which has a
longitudinal seam defining leg portions within which the other
components fit in a telescoping manner.
Inventors: |
Pinchuk; Leonard; (Miami,
FL) ; Alcime; Rysler; (Miami, FL) ; Kato;
Yasushi; (Pembroke Pines, FL) |
Correspondence
Address: |
RATNERPRESTIA
P.O. BOX 980
VALLEY FORGE
PA
19482
US
|
Family ID: |
24227879 |
Appl. No.: |
11/906703 |
Filed: |
October 3, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09657041 |
Sep 5, 2000 |
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11906703 |
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08863964 |
May 27, 1997 |
5855598 |
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09657041 |
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08558028 |
Nov 13, 1995 |
5632772 |
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08863964 |
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08558034 |
Nov 13, 1995 |
5639278 |
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08558028 |
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08140245 |
Oct 21, 1993 |
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08558034 |
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08140245 |
Oct 21, 1993 |
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08140245 |
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Current U.S.
Class: |
623/1.13 ;
623/1.2; 623/1.35 |
Current CPC
Class: |
A61F 2240/001 20130101;
A61F 2002/30329 20130101; A61F 2220/0075 20130101; A61F 2/90
20130101; A61F 2230/0078 20130101; A61F 2/07 20130101; A61F
2002/826 20130101; A61F 2220/0008 20130101; A61F 2002/065 20130101;
A61F 2002/067 20130101; A61F 2/91 20130101; A61F 2/88 20130101;
A61F 2002/075 20130101; A61F 2/89 20130101; A61F 2002/072 20130101;
A61F 2250/0039 20130101; A61F 2220/0025 20130101; A61F 2220/005
20130101; A61F 2230/001 20130101; A61F 2220/0058 20130101; A61F
2/885 20130101 |
Class at
Publication: |
623/1.13 ;
623/1.35; 623/1.2 |
International
Class: |
A61F 2/06 20060101
A61F002/06 |
Claims
1-42. (canceled)
43. An endoluminal support device comprising: a
radially-expandable, bifurcated support, the support including: a
first support portion, and a second support portion including a
first lobe and a second lobe, and a longitudinal isthmus between
the first lobe and the second lobe, the first and second lobes
having smaller diameters than the first portion; and a liner
coupled to the radially-expandable, bifurcated support, wherein the
endoluminal support device has an uninterrupted cross-section over
its entire length.
44. The endoluminal support device of claim 43, wherein the liner
is coupled to an interior side of the radially-expandable,
bifurcated support.
45. The endoluminal support device of claim 43, wherein the liner
is coupled to an exterior side of the radially-expandable,
bifurcated support.
46. The endoluminal support device of claim 43, wherein each of the
first and second lobes is adapted to receive a branch support.
47. A branching endovascular prosthesis comprising: a radially
expandable support, the support including: a distal support portion
comprising at least one expandable circumferential portion, and a
proximal support portion including a first lobe and a second lobe
separated from the first lobe by an isthmus, and a bifurcated liner
coupled to the distal support portion and to the proximal support
portion, wherein the branching endovascular prosthesis has an
uninterrupted cross-section over its entire length.
48. The prosthesis of claim 47, wherein the bifurcated liner is
coupled to an interior side of the distal support portion and to an
interior side of the proximal support portion.
49. The prosthesis of claim 47, wherein the bifurcated liner is
coupled to an exterior side of the distal support portion and to an
exterior side of the proximal support portion.
50. The prosthesis of claim 47, wherein the prosthesis is self
expanding.
51. A branching endovascular prosthesis comprising: a distal
support portion comprising at least one radially expandable
portion; a proximal support portion coupled to the distal support
portion, the proximal support portion including a first radially
expandable lobe and a second radially expandable lobe separated
from the first lobe by an isthmus; and a bifurcated liner coupled
to the distal support portion and to the proximal support portion,
wherein the branching endovascular prosthesis has an uninterrupted
cross-section over its entire length.
52. The prosthesis of claim 51, wherein the bifurcated liner is
coupled to an interior side of the distal support portion and to an
interior side of the proximal support portion.
53. The prosthesis of claim 51, wherein the bifurcated liner is
coupled an exterior side of the distal support portion and to an
exterior side of the proximal support portion.
54. A branching endoluminal prosthesis comprising: a liner and a
radially expandable support coupled to said liner; wherein said
liner comprises: a main body having a proximal portion and a distal
portion, said proximal portion including a main lumen, and said
distal portion including a first branch having a first lumen
extending to a first distal end, and a second branch having a
second lumen extending to a second distal end, the first and second
branch lumens being in communication with the main lumen and
extending through said distal portion to define a bifurcation
extending to said first and second distal ends; and wherein said
support comprises: a distal support portion disposed over said
distal portion of said main body, said distal support portion
comprising at least one expandable circumferential portion defining
a first lobe supporting said first branch, a second lobe supporting
said second branch, and opposed indentations to support and
separate said first and second branches, wherein said branching
endoluminal prosthesis has an uninterrupted cross-section over its
entire length.
55. The branching endoluminal prosthesis of claim 54 wherein said
support further comprises an expandable proximal circumferential
portion supporting said proximal portion of said main body.
56. The branching endoluminal prosthesis of claim 54 further
comprising an attachment mechanism which couples said distal
support to said distal portion of said main body of said liner.
57. The branching endoluminal prosthesis of claim 56 wherein said
attachment mechanism attaches said first lobe and a portion of each
indentation to the first branch.
58. The branching endoluminal prosthesis of claim 57 wherein said
attachment mechanism attaches said second lobe and a portion of
each indentation to the second branch.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This is a divisional application of application Ser. No.
09/657,041, filed Sep. 5, 2000, which is a reissue application of
U.S. Pat. No. 5,855,598 issued Jan. 5, 1999, which is a
continuation-in-part of application Ser. No. 08/558,028, filed Nov.
13, 1995, filed Nov. 13, 1995, now U.S. Pat. No. 5,632,772 and
application Ser. No. 08/558,034, filed Nov. 13, 1995, now U.S. Pat.
No. 5,639,278, which are each a continuation-in-part of application
Ser. No. 140,245, filed Oct. 21, 1993, now abandoned and is related
to divisional reissue application Ser. No. 10/788,966, filed Feb.
25, 2004, and continuation reissue application Ser. No. 11/332,917,
filed Jan. 17, 2006.
BACKGROUND AND DESCRIPTION OF THE INVENTION
[0002] This invention generally relates to supportive endoluminal
grafts which have the ability to be delivered transluminally and
expanded in place to provide a graft that is endoluminally
positioned and placed, with the aid of an appropriate inserter or
catheter, and that remains so placed in order to both repair a
vessel defect and provide lasting support at the location of the
graft. In its broadest sense, the graft preferably combines into a
single structure both an expandable luminal prosthesis tubular
support component and a compliant graft component secured thereto.
The expandable supportive endoluminal graft takes on a bifurcated
or branched structure made up of components that are designed to be
positioned in a bifurcated manner with respect to each other,
preferably during deployment or repair and support of vessel
locations at or near branching sites. Preferably, the graft
component is compliant, stretchable or elastomeric and does not
substantially inhibit expansion of the tubular support component
while simultaneously exhibiting porosity which facilitates normal
cellular growth or invasion thereinto of tissue from the body
passageway after implantation.
[0003] Elastomeric vascular grafts are known to be made by various
methods. Included are methods which incorporate electrostatic
spinning technology such as that described by Annis et al. in "An
Elastomeric Vascular Prosthesis", Trans. Am. Soc. Artif. Intern.
Organs, Vol. XXIV, pages 209-214 (1978) and in U.S. Pat. No.
4,323,525. Other approaches include elution of particulate material
from tubular sheeting, such as by incorporating salts, sugars,
proteins, water-soluble hydrogels, such as polyvinyl pyrrolidone,
polyvinyl alcohol, and the like, within polymers and then eluting
the particulate materials by immersion in water or other solvent,
thereby forming pores within the polymer. Exemplary in this regard
is U.S. Pat. No. 4,459,252, incorporated by reference hereinto.
Another approach involves the forming of pores in polymers by phase
inversion techniques wherein a solventized polymer is immersed in
another solvent and the polymer coagulates while the polymer
solvent is removed. Also known are spinning techniques such as
those described in U.S. Pat. No. 4,475,972. By that approach, a
polymer such as a polyurethane in solution is extruded as fibers
from a spinnerette onto a rotating mandrel. The spinnerette system
reciprocates along a path which is generally parallel to the
longitudinal axis of the mandrel and at a controlled pitch angle.
The result is a non-woven structure where each fiber layer is bound
to the underlying fiber layer.
[0004] Also known are stent devices, which are placed or implanted
within a blood vessel or other body cavity or vessel for treating
occlusions, stenoses, aneurysms, disease, damage or the like within
the vessel. These stents are implanted within the vascular system
or other system or body vessel to reinforce collapsing, partially
occluded, weakened, diseased, damaged or abnormally dilated
sections of the vessel. At times, stents are used to treat disease
at or near a branch, bifurcation and/or anastomosis. This runs the
risk of compromising the degree of patency of the primary vessel
and/or its branches or bifurcation, which may occur as a result of
several problems such as displacing diseased tissue, vessel spasm,
dissection with or without intimal flaps, thrombosis and
embolism.
[0005] One common procedure for implanting a stent is to first open
the region of the vessel with a balloon catheter and then place the
stent in a position that bridges the diseased portion of the
vessel. Various constructions and designs of stents are known. U.S.
Pat. No. 4,140,126 describes a technique for positioning an
elongated cylindrical stent at a region of an aneurysm to avoid
catastrophic failure of the blood vessel wall, the stent being a
cylinder that expands to an implanted configuration after insertion
with the aid of a catheter. Other such devices are illustrated in
U.S. Pat. Nos. 4,787,899 and 5,104,399. U.S. Pat. Nos. 4,503,569
and 4,512,338 show spring stents which expand to an implanted
configuration with a change in temperature. It is implanted in a
coiled configuration and then heated in place to cause the material
of the spring to expand. Spring-into-place stents are shown in U.S.
Pat. No. 4,580,568. U.S. Pat. No. 4,733,665 shows a number of stent
configurations for implantation with the aid of a balloon catheter.
U.S. Pat. No. 5,019,090 shows a generally cylindrical stent formed
from a wire that is bent into a series of tight turns and then
spirally wound about a cylindrical mandrel to form the stent. When
radially outwardly directed forces are applied to the stent, such
as by the balloon of an angioplasty catheter, the sharp bends open
up and the stent diameter enlarges. U.S. Pat. No. 4,994,071
describes a bifurcating stent having a plurality of wire loops that
are interconnected by an elongated wire backbone and/or by wire
connections and half hitches.
[0006] Stents themselves often do not encourage normal cellular
invasion and can lead to undisciplined development of cells in the
stent mesh, with rapid development of cellular hyperplasia. Grafts
alone do not provide adequate support in certain instances.
Copending application of Jean-Pierre Dereume, Ser. No. 08/546,524,
entitled "Luminal Graft Endoprostheses and Manufacture Thereof"
describes grafts that have the ability to carry out dilatation
and/or support functions. An expandable tubular support component
and an elastomeric graft component are combined into a single
device wherein the graft material is secured to either or both of
the internal and external surfaces of the expandable support
component. The graft material is produced by a spinning technique
such as that described in U.S. Pat. No. 4,475,972. Also, luminal
endoprostheses with an expandable coating on the surface of
external walls of radially expandable tubular supports are proposed
in U.S. Pat. Nos. 4,739,762 and 4,776,337. In these two patents,
the coating is made from thin elastic polyurethane, Teflon film or
a film of an inert biocompatible material. A. Balko et al.,
"Transfemoral Placement of Intraluminal Polyurethane Prosthesis for
Abdominal Aortic Aneurysm", Journal of Surgical Research, 40,
305-309, 1986, and U.S. Pat. Nos. 5,019,090 and 5,092,877 mention
the possibility to coat stent materials with porous or textured
surfaces for cellular ingrowth or with non-thrombogenic agents
and/or drugs. The various patents and publications referred to
hereinabove are incorporated hereinto by reference.
[0007] By the present invention, grafts which are expandable and
supportive are provided that expand from a first diameter to a
second diameter which is greater than the first. When it is at its
first diameter, the expandable supportive graft is of a size and
shape suitable for insertion into the desired body passageway. The
material of the graft is substantially inert and preferably has a
generally cylindrical cover and/or lining generally over the
outside and/or inside surface of the expandable supportive
component. Preferably, the cover and/or lining is especially
advantageous because it is compliant or elastomeric and porous to
encourage desirable growth of tissue thereinto in order to assist
in non-rejecting securement into place and avoidance of stenosis
development. The porous liner and/or cover material is compliant or
elastomeric enough to allow for expansion by up to about 2 to 4
times or more of its unexpanded diameter. Components of the
branched or bifurcated expandable supportive endoluminal graft
preferably are deployable separately such that each component is
properly positioned with respect to the other into the desired
branched or bifurcated arrangement. One of the components has a
portion which has at least one longitudinally disposed indent to
generally define at least two leg portions for receiving one of the
other components.
[0008] It is a general object of the present invention to provide
an improved branched endoluminal graft that is expandable in place
and, once expanded, is self-supporting.
[0009] Another object of this invention is to provide biocompatible
grafts having a plurality of components that are separately
expandable in vivo and that are supportive once so expanded.
[0010] Another object of the present invention is to provide an
improved expandable reinforced graft that is delivered by way of
introducers, balloon catheters or similar devices, and which
facilitates good tissue ingrowth.
[0011] Another object of this invention is to provide an improved
endoluminal graft which fully covers diseased or damaged areas for
carrying out luminal repairs or treatments, such as repair of
aneurysms.
[0012] Another object of the present invention is to provide an
improved endoluminal graft wherein the endoprosthesis is
substantially enclosed within biocompatible compliant material
which is presented to the surrounding tissue and blood or other
body fluid.
[0013] Another object of this invention is to provide an
expandable, supportive graft that can be tailored to meet a variety
of needs, including a single graft designed to address more than a
single objective.
[0014] Another object of the present invention is to provide a
self-expanding reinforced graft device that is delivered in its
elongated and compressed state from within a tubular member and
deployed by moving same out of the tubular member, which device is
especially suitable for component deployment.
[0015] Another object of this invention is to provide a bifurcated
trunk component that is deployed in a collapsed state and expanded
in vivo to a branched device for use in treatment and/or repair at
branched vessel locations.
[0016] A further object of the present invention is to provide a
component branched endoluminal graft having a longitudinally
creased trunk component and at least one cylindrical branch
component, which components are expanded separately after
endoluminal delivery and which form a bifurcated graft once
positioned with respect to each other and expanded.
[0017] Another object of this invention is to provide an improved
method of forming a branched endoluminal graft incorporating a
longitudinal creasing procedure.
[0018] Another object of the present invention is to provide an
improved method of assembling a branched endoluminal graft.
[0019] These and other objects, features and advantages of this
invention will be clearly understood through a consideration of the
following detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] The invention will be further elucidated in the following
description with reference to the drawings, in which:
[0021] FIG. 1 is a perspective view, partially cut away, of an
expandable supportive endoluminal graft construction in accordance
with the invention;
[0022] FIG. 2 is a cross-sectional view along the line 2-2 of FIG.
1;
[0023] FIG. 3 is a perspective view, partially cut away, of another
embodiment of the expandable supportive endoluminal graft
construction;
[0024] FIG. 4 is a cross-sectional view along the line 4-4 of FIG.
3;
[0025] FIG. 5 is a perspective view, partially cut away, of a
further embodiment of the expandable luminal graft
construction;
[0026] FIG. 6 is a cross-sectional view along the line 6-6 of FIG.
5;
[0027] FIG. 7 is a perspective view, partially cut away, of a
bifurcated expandable supportive endoluminal graft
construction;
[0028] FIG. 8 is a cross-sectional view along the line 8-8 of FIG.
7;
[0029] FIG. 9 is a somewhat schematic view illustrating an early
step in the implantation of a device such as shown in FIG. 7;
[0030] FIGS. 10, 11 and 12 are generally schematic views along the
lines of FIG. 9 showing expansion of the main body and the branches
of this bifurcated device;
[0031] FIG. 13 shows this bifurcated supportive graft after
completion of the expansion procedure;
[0032] FIG. 14 illustrates another embodiment of a bifurcated
expandable supportive endoluminal graft construction;
[0033] FIGS. 15, 16 and 17 illustrate implantation and assembly of
the graft of FIG. 14;
[0034] FIGS. 18, 19, 20 and 21 illustrate a component branched
graft and various stages of its separate, component deployment
within a body vessel to repair an aneurysm, FIGS. 18 and 19 showing
deployment of a preferred branched, longitudinally indented trunk
component, and
[0035] FIGS. 20 and 21 showing separate deployment of two branch
components within the trunk component;
[0036] FIG. 22 is a top plan view of an embodiment of a branching
trunk component in accordance with the invention;
[0037] FIG. 23 is a cross-sectional view along the line 23-23 of
FIG. 22;
[0038] FIG. 24 is a side elevational view of the branching trunk
component as illustrated in FIGS. 22 and 23;
[0039] FIG. 25 is an end view of the structure as shown in FIG.
24;
[0040] FIG. 26 is a perspective, generally exploded view of an
example of a fixture suitable for forming the longitudinal crease
in this trunk component;
[0041] FIG. 27 is a longitudinal broken-away view of the fixture of
FIG. 26 with a braided cylindrical tube positioned therein;
[0042] FIG. 28 is a view generally in accordance with FIG. 27,
showing formation of opposing crease indents in the braided
cylindrical tube during formation of this trunk component;
[0043] FIG. 29 is a top plan view showing assembly of supportive
endoprosthesis leg components into a branching trunk component
according to the invention;
[0044] FIG. 30 is an end view of the structure as shown in FIG.
29;
[0045] FIG. 31 is a perspective view of another embodiment of a
branching trunk component in accordance with the invention;
[0046] FIG. 32 is a cross-sectional view along the line 32-32 of
FIG. 31; and
[0047] FIG. 33 is a perspective view of a modified embodiment of a
branching trunk component, having a section of enhanced hoop
strength.
DESCRIPTION OF THE PARTICULAR EMBODIMENTS
[0048] An embodiment of expandable supportive luminal graft
construction is generally illustrated in FIG. 1 at 21. This
embodiment includes a braided tubular support component having
generally helically wound rigid but flexible strand or wire
elements, some of which have the same direction of winding but are
axially displaced from one another, and others of which cross these
windings and are also axially displaced with respect to each other.
The actual structure can be generally braided as illustrated in
Wallsten U.S. Pat. No. 4,655,771, incorporated by reference
hereinto, or as found in self-expanding braided flat wire
Wallstent.RTM. devices. Both a cover 23 and a liner 24 are
illustrated in FIGS. 1 and 2. Either cover 23 or liner 24 can be
omitted if there is no desire to substantially encapsulate the
tubular support component 22.
[0049] With more particular reference to the illustrated cover 23
and liner 24, when included, they may be formed by an electrostatic
spinning process in this illustrative embodiment. Details regarding
electrostatic spinning techniques in general are found in Bornat
U.S. Pat. No. 4,323,525 and in Bornat European patent publication
No. 9,941, as well as in the Annis et al. article discussed
hereinabove, the disclosures of which are incorporated by reference
hereinto. With further reference to the application of this
technology to the expandable supportable luminal grafts of the
present invention, random pattern filaments are formed and
electrostatically directed toward a charged mandrel in order to
form a random pattern of electrostatically generally cross-linked
filaments which take on the configuration of a mat having a
cylindrical shape. The filament diameters are particularly fine, as
is the pore size of the mat so constructed. A typical range of
filament diameters is between about 0.5 micron and about 5 microns,
and a typical pore size of the electrostatically spun fiber is
between about 3 microns and about 20 microns.
[0050] Liner 24 is formed directly on the rotating mandrel by this
electrostatic spinning procedure. Thereafter, one of the tubular
support components discussed herein, such as the generally braided
tubular support 22, is placed over the liner 24 still on the
mandrel. In the case of the tubular support 22 in a form that is
not spring loaded, this includes longitudinally extending the
tubular support 22, such as by pulling one or both of its ends,
which thereby decreases its diameter so that it fits snugly over
the liner 24. When the generally braided tubular support 22 is of a
spring-into-place type, a hold-down member (such as shown in FIGS.
18 and 20) is used to prevent automatic radial expansion prior to
deployment. When the expandable supportive graft 21 is to include a
cover 23, the mandrel is again rotated, and the electrostatic
spinning is again accomplished in order to form the cover 23
directly over the tubular support 22. This will also create some
bonding between the thus formed cover 23 and the liner 24 at
openings between the strands or wires of the woven tubular support
22 or the like. This bonding can be facilitated by uniformly
compressing the outer fibers with a soft silicone roller or sponge
such that the still tacky outer fibers bond to the inner fibers
thereby encapsulating the tubular support within the graft.
[0051] Bonding may also be achieved in this or other embodiments by
heat welding and/or by the use of adhesives such as hot melt
adhesives, primers, coupling agents, silicone adhesives, and the
like, and combinations of these. Examples include aliphatic
polycarbonate urethane hot melts and silicone rubber adhesives.
[0052] It is important to note that each of the cover 23 and the
liner 24, when either or both are present, is made of an
elastomeric material which retains its compliant properties after
construction of the expandable supportive graft 21 is completed. In
this regard, the graft itself is also elastomeric and compliant.
Accordingly, the graft 21 is delivered transluminally, such as by
being pulled down onto the balloon of a catheter or into an
inserter tube and then percutaneously inserted and positioned to
the location where the repair is needed. For a non-spring loaded
graft, the balloon is then inflated to longitudinally shorten and
radially expand the graft 21 into engagement with the vessel walls.
Because of the compliance of the cover 23 and/or liner 24, and
because of the hoop strength of the braided tubular support 22, the
graft 21 will remain in place. In the illustrated embodiment, ends
25 of the tubular support are exposed and are not covered by the
cover 23. This allows the exposed end portions 25 to directly
engage the vessel wall, if desired in the particular application,
in order to assist in anchoring the graft 21 in place. Liner 24
also can be sized so as to not cover the exposed ends 25, or it can
extend to or beyond the edge of the ends 25 when it is desired to
avoid or minimize contact between the tubular support and the blood
or other fluid flowing through the vessel being repaired or
treated.
[0053] Alternatively, when a braided tubular support such as that
illustrated in FIGS. 1 and 2 is incorporated into the graft
according to the present invention in a non-spring-loaded form,
transluminal delivery can be made by way of a catheter or tool
having means for longitudinally compressing the endoprosthesis
until it has expanded radially to the desired implanted diameter.
Such equipment typically includes a member that engages one end of
the endoprosthesis and another member which engages the other end
of the endoprosthesis. Manipulation of proximally located controls
then effects relative movement of the members toward each other in
order to thereby longitudinally compress the endoprosthesis.
Delivery tools for spring-loaded grafts include a sleeve that
maintains the graft at its compressed diameter until the graft is
positioned for deployment such as from the end of an insertion
catheter to its auto-expanded state.
[0054] With reference to the embodiment illustrated in FIGS. 3 and
4, an expandable supportive graft is illustrated at 31. The
illustrated tubular support component 32 is constructed of
sinusoidally configured wire helically wound into a tubular shape.
General structures of these types are generally discussed in
Pinchuk U.S. Pat. No. 5,019,090, incorporated by reference
hereinto. A cover 33 can be positioned over the tubular support 32
and/or a liner 34 can be positioned along its lumen. In this
illustrated embodiment, the cover 33 and liner 34 are constructed
of porous polymers, the pores thereof having been made by elution
or extraction of salts and the like, such as described in MacGregor
U.S. Pat. No. 4,459,252, incorporated by reference hereinto.
Generally speaking, the porosity is determined by the size of the
elutable particles as discussed herein and by the concentration of
those particles as a percent by volume of a pre-elution mixture
thereof with the polymer of the cover or liner. When a graft 31
having both a cover 33 and a liner 34 is prepared, a mandrel or rod
is dipped into a liquid polymer having elutable particles as
discussed herein dispersed therewithin. After dipping, the polymer
covered rod is contacted with, such as by dipping or spraying, a
solvent, for the elutable particles, such as water, thereby forming
the eluted porous liner 34. Thereafter, the tubular support 32 is
positioned thereover and pressed down into the liner. Then, the rod
and the assembly thereon are again dipped into the mixture of
polymer and elutable particles, followed by setting and contact
with solvent to remove the elutable particles in order to form the
eluted porous cover 33. It is also possible to directly extrude the
particle-containing polymer into a tubular shape.
[0055] Elutable particles which can be used in the making of the
eluted porous cover 33 and liner 34 include salts such as sodium
chloride crystals, sodium carbonate, calcium fluoride, magnesium
sulfate and other water-soluble materials that are readily
dissolved by the utilization of water as an elution medium. Other
particles that are soluble in organic solvents and the like can be
substituted as desired. Further particles include sugars, proteins,
and water-soluble hydrogels such as polyvinyl pyrrolidone and
polyvinyl alcohol. Suitable polymer materials are as discussed
elsewhere herein, the pore size being on the order of about 10
microns to about 80 microns.
[0056] As with the other embodiments, when desired, ends 35 of the
support component 32 can be exposed either on one or both of its
cylindrical faces in accordance with the needs of the particular
repair or treatment to be carried out. With this approach, the
exposed ends 35 will assist in maintaining the graft 32 in place by
mechanical engagement between the exposed ends 35 and the vessel
being repaired or treated and/or by tissue ingrowth. The anchoring
aspect of the exposed ends of the tubular support can be enhanced
by continued radial expansion of the balloon or other deployment
means which will permit the exposed ends to expand radially
outwardly in an amount somewhat greater than that of the rest of
the expandable supportive graft and into the surrounding tissue. It
is also contemplated that mechanical means can be used to assist in
joining the exposed ends of this embodiment or of other embodiments
to the vessel wall. An illustrative example in this regard is the
use of transluminally delivered staples which can take on the
appearance of rivets. Especially advantageous are staples made of
an elastomeric material. Illustrated staples are shown at 36 in
FIG. 3. They can be incorporated at other locations as well along
the graft. One or more windows 37 can be formed through the cover
and/or liner and/or tubular support in order to feed outside branch
arteries or other vessels.
[0057] FIGS. 5 and 6 illustrate a further embodiment of an
expandable supported graft, generally designated as 41. Shown is a
mesh tubular support component, generally designated as 42, such as
those of the type illustrated in Palmaz U.S. Pat. No. 4,733,665,
incorporated by reference hereinto. These are non-woven mesh-type
cylinders or slotted tubes wherein most or all of the individual
components are either integrally joined together such as by welding
or are integrally formed from a single tube. The resulting
endoprostheses are malleable enough so as to be expandable by a
balloon of a catheter. Usually, these endoprostheses have
particularly high hoop strengths.
[0058] Cover 43 and/or liner 44 are made of polymers rendered
porous by phase inversion techniques. In accordance with these
techniques, a polymer such as a polyurethane is dissolved in a
solvent therefor, for example a water-soluble polar solvent, such
as dimethyl acetamide, tetrahydrofuran and the like, in order to
form what is known as a lacquer. A mandrel or rod is dipped into
the lacquer. Thereafter, the dipped rod is contacted with an
inversion solvent, such as by dipping in water or a mixture of
alcohol and water. This inversion solvent must readily dissolve the
polymer solvent of the lacquer, while at the same time being a poor
solvent for the polymer. Under these conditions, the polymer
coagulates and the polymer solvent of the lacquer is removed and
replaced with the inversion solvent. The inversion solvent pulls
the polymer solvent out of the polymer on the rod and forms
particularly fine pores having a pore size on the order of about
0.5 micron to about 20 microns. The thus formed liner 44 having
phase inversion pores is then dried.
[0059] Next, the tubular support component 42 is secured over the
liner 44 and is preferably radially compressed onto and into the
liner. Thereafter, the cover 43 having phase inversion pores is
formed in accordance with the same phase inversion steps as
discussed hereinabove for preparation of the liner 44. If desired,
either the liner or the cover can be omitted. Cover 43 and liner 44
are thus formed in accordance with a displacing step wherein
precipitating non-solvent molecules are substituted for
non-precipitating solvent molecules dispersed throughout the
lacquer coating. This procedure develops advantageous elastic
characteristics. Further details regarding the phase inversion
procedure are found in Lymann et al. U.S. Pat. No. 4,173,689,
incorporated by reference hereinto.
[0060] FIGS. 7 and 8 illustrate an embodiment wherein the graft
takes the form of a bifurcated expandable supportive graft,
generally designated at 51. Included is a joined-ring bifurcated
tubular support 52. Also shown are a bifurcated cover 53, a
bifurcated lining 54 and exposed ends 55, 56, 57. This particular
bifurcating graft is well-suited for insertion into a branching
vessel.
[0061] The tubular support includes a plurality of rings or loops
58 connected by flexible interconnections 59. Constructional
details of embodiments of the rings or loops 58 and of the flexible
interconnections 59 are found in MacGregor U.S. Pat. No. 4,994,071,
incorporated by reference hereinto. The flexible interconnections
59 join the rings or loops 58 into a configuration having a main
body or trunk 61 and one or more branches 62. Flexible
interconnections 59 extend longitudinally from the axis of each of
the main body or trunk 61 and branch 62, 63. At least one such
flexible interconnection joins each branch to the trunk. The loops
58 in the main body are substantially parallel to each other, and
the loops 58 in each branch 62, 63 are substantially parallel to
each other.
[0062] The bifurcated cover 53 and bifurcated liner 54 must each,
when provided, be especially elastomeric so as to follow the
expansion and contraction of the rings or loops 58 that takes place
during preparation, transluminal insertion, deployment and the
like. Cover 53 and liner 54 will also take on a bifurcated
construction. In one embodiment, the liner and/or cover for each of
the trunk 61 and branch 62, 63 are made on a cylindrical mandrel,
assembled and joined, such as by suitable biocompatible adhesive,
fusion, sewing, suturing or other means of joining and/or sealing.
Alternatively, a Y-shaped or branched mandrel can be used. The
bifurcating liner is then formed thereon by processes such as those
discussed herein, including electrostatic spinning, or dipping
followed by elution or phase inversion procedures much in the same
manner as described herein when straight cylindrical mandrels or
rods are used for constructing the non-bifurcated grafts in
accordance with this invention. Fiber winding can also be
practiced. Bifurcated cover 53 is made in a similar manner by
application of the porous cover material over the bifurcated
endoprosthesis.
[0063] With reference to the bifurcated endoprosthesis, the
bifurcated cover 53 and/or bifurcated liner 54 could be made by
fiber winding approaches, such as those described in Wong U.S. Pat.
No. 4,475,972, the subject matter thereof being incorporated by
reference hereinto. Polymer in solution is extruded into fibers
from a spinnerette onto a rotating mandrel. The spinnerette is
reciprocated along the longitudinal axis of the mandrel at a
controlled pitch angle, resulting in a non-woven cylinder wherein
each fiber layer is bound to the underlying layer. Control of the
pitch angle allows for control of the compliance and kink
resistance of the cover and/or liner. In an especially advantageous
arrangement when using these fiber spinning techniques in forming
an expandable supportive graft in accordance with the general
aspects of this invention which has both a liner and a cover, the
cover is physically bonded to the liner by the use of an
electrostatic field to enable penetration of the cover overlay of
fibers through the interstices of the support components in order
to improve the bonding of the cover and/or liner fibers to each
other and/or to surfaces of the support component.
[0064] With more particular reference to balloon deployment of
expandable supportive grafts, this is illustrated with some
particularity in connection with bifurcated endoluminal grafts in
FIGS. 9, 10, 11, 12 and 13. As shown in FIG. 9, two guidewires 64,
65 are inserted into the bifurcating vessel, each of them into
different legs 66, 67 of the bifurcating vessel. Thereafter, the
unexpanded bifurcated expandable supportive graft 51 is slipped
over the proximal ends of the guidewires and routed to the branches
of the blood vessel. The unexpanded bifurcated graft can be
introduced from an arteriotomy proximal to the bifurcation such as
from the brachial artery in the arm, or the unexpanded bifurcated
graft can be introduced from the femoral artery in the leg, pushed
proximally past the bifurcation and then pulled back distally into
both iliacs to form the trunk and bifurcation.
[0065] The two branches 62, 63 of the graft 51 are routed
separately over the guidewires 64, 65, respectively, and guided,
typically with the help of a guide catheter, into the patient until
the graft is positioned as shown in FIG. 9. The graft 51 is
initially fixed in place as follows. One of the guidewires 65 is
removed, and a balloon catheter 68 is inserted into the main body
or trunk 61 and inflated to expand the trunk 61 into contact with
the vessel walls. This deployment is suitable to secure the graft
51 in place at that location of the vessel.
[0066] The balloon of balloon catheter 68 is then deflated. If this
balloon catheter is also suitable for use in expanding the branches
62, 63 of the graft 51, same is then inserted into an unexpanded
branch 62 and radially expanded as generally shown in FIG. 11. If
the balloon of catheter 68 is not suitable in this regard, then
another balloon catheter 69 effects this function. FIG. 12 shows
inflation of the other branch 63 of the graft 51 in a similar
manner. FIG. 13 illustrates the fully deployed and expanded
bifurcated support graft 51 positioned in place within the
bifurcated location. Alternatively, a bifurcated dilation balloon
on a bifurcated catheter (not shown) can replace the single-balloon
catheter(s) 68, 69.
[0067] Preferably the branched and assembled expandable supportive
graft is of the spring-into-place type; as such, it will be
manipulated to be reduced in diameter and placed within an
overlying and bifurcated restraining guiding catheter or the like
and will be passed over guidewires and contained within the guiding
catheter until proper placement within the bifurcating location.
This type of bifurcated expandable supportive graft is deployed by
being ejected into place, typically by advancing a small inner
catheter through the guiding catheter into contact with the
bifurcating graft in accordance with the procedure generally used
for spring-into-place stents.
[0068] The deployment procedures illustrated in FIGS. 9 through 13
can be characterized as prograde deployment. Retrograde deployment
is also possible. The entire bifurcating graft for retrograde
deployment is advanced over a single guidewire through one branch
of the blood vessel past the point of bifurcation. A second
guidewire is then steered down the opposite limb of the graft, and
a snare is used. The snare, which is passed retrograde through the
opposite vessel, is then used to pull the guidewire into place.
Partial balloon inflation in the unbranched or trunk portion of the
blood vessel is then used to draw the graft down into position
prior to balloon dilatation of both the trunk and branched portions
of the graft. Because blood flow is prograde under these
circumstances, the contact between the bifurcation of the graft and
the bifurcation of the blood vessel helps to prevent the graft from
migrating distally, thus reducing the need for active fixation of
the graft to the blood vessel.
[0069] Another bifurcated endoprosthesis or expandable supportive
graft is generally designated 81 in FIG. 14. Separate components
are included. In this case tubular supporting component(s) are,
prior to deployment, separate from a trunk component. In this
embodiment, a fully independent tubular supporting component 82 is
located at the trunk position of the graft 81. A bifurcated
stretchable wall 83 is in contact with the independent tubular
supporting component 82 as either or both of a cover or liner. In
addition to being substantially coextensive with the independent
tubular supporting component 82 at a trunk portion 84 thereof, the
stretchable wall 83 includes at least two generally tubular
stretchable branch sleeves 85, 86 which are initially devoid of a
supporting component. Separate tubular supporting components 87, 88
(FIGS. 16 and 17) are also included.
[0070] Implantation of this bifurcated expandable supportive graft
is depicted in FIGS. 14, 15, 16 and 17. Dual guidewires 64, 65 can
be used to properly position the unexpanded bifurcated graft 81
within the bifurcating vessel as shown in FIG. 14. A balloon
catheter 68 or similarly functioning device is inserted into the
main body of the device so as to expand the independent tubular
supporting component 82 and the trunk portion 84 of the bifurcated
stretchable wall 83. This deployment initially secures the
bifurcated supporting graft into place at that location of the
vessel, as shown in FIG. 15. The balloon catheter is then deflated
and removed or positioned for use in the next step.
[0071] A suitable balloon catheter 69 or the like is next used to
deploy and expand in place a branch tubular expandable supporting
component 89, as illustrated in FIG. 16. A similar step deploys and
expands in place another branch tubular expandable supporting
component 90, as generally shown in FIG. 17. The bifurcated
stretchable wall 83 and the expandable supporting components may be
made with the materials and constructions discussed herein and may
be subjected to various treatments as discussed.
[0072] A further bifurcated endoprosthesis or expandable supportive
graft is one in which the separate components are each expandable
supportive graft members. These separate components are illustrated
in FIG. 18 through FIG. 21, which also illustrate their separate
deployment with respect to each other within an aortic trunk. Same
is shown in connection with treating an aneurysm such as an
abdominal aorto-iliac aneurysm. The device includes a trunk
component 101 which, in the illustrated use, is designed to extend
from below the renal arteries to a location between the proximal
neck of the aneurysm and the aorto-iliac bifurcation. It will be
understood that this trunk component could also be shorter so that
it terminates just below the proximal neck of the aneurysm, for
example of a length which terminates within the dent or crease 124.
In addition, the component bifurcated expandable supportive graft
of this embodiment is self-expanding and is deployed by means of an
introducer containing compressed expandable supportive graft
components.
[0073] More particularly, and with reference firstly to FIG. 18, a
guidewire 102 is first inserted in accordance with known procedures
so as to traverse the aneurysm 103. Next, an introducer, generally
designed as 104 having the trunk component therewithin in a
radially compressed state is inserted over the guidewire 102. The
introducer is maneuvered such that it is properly positioned as
desired, in this case at a location distal of the distal end of the
aneurysm. Then, the sheath 105 of the introducer is withdrawn, such
as by sliding it in a proximal direction while the remainder of the
introducer 104 remains in place. As the sheath is withdrawn, the
trunk 101 expands, eventually achieving the deployed or implanted
position shown in FIG. 19. At this stage, the distal portion 106 of
the trunk is well anchored into the blood vessel wall and is
suitably deployed.
[0074] FIG. 20 shows an introducer, generally designated as 107,
having an independent tubular expandable supportive graft leg
component 108 (FIG. 21) radially compressed therewithin. In this
illustrated embodiment, this leg component is an iliac component of
the bifurcated supportive graft being assembled within the body
vessel. The introducer 107 is advanced until this iliac component
is moved into a leg 109 of the already deployed trunk component
101. This positioning is illustrated in FIG. 21. It will be noted
that the iliac tubular supportive graft component 108 extends from
well within the leg 109 to a location proximal of the aneurysm in
the iliac artery 110.
[0075] In a previous step, a guidewire had been passed through the
appropriate vessel to iliac artery 112 until it crossed the
aneurysm 103, while passing through the other leg 113 of the
deployed trunk component 101. When the introducer for the
previously radially compressed iliac component 115 had been
removed, the component 115 had expanded radially and was deployed.
Thus, the entirety of the bifurcated endoprosthesis or expandable
supportive graft in accordance with this embodiment is fully
deployed and assembled together as shown in FIG. 21, as well as
generally depicted in FIGS. 29 and 30.
[0076] It will be noted that it is not required to actually attach
the trunk component 101 and the tubular components 108, 115
together. In other words, these components are generally
telescopically positioned with respect to each other. This
telescopic feature allows some slippage between the trunk component
and the tubular leg components, thereby providing a telescopic
joint which functions as a slip bearing. It will be appreciated
that it is generally desirable to firmly anchor portions of the
bifurcated endoprosthesis within healthy vessel wall tissue. This
can be achieved by the hoop strength of the supportive graft or by
taking measures to enhance hoop strength at its ends, or by
providing grasping structures such as hooks, barbs, flared ends and
the like. During pulsetile blood flow and possibly during exercise
by the person within which the endoprosthesis is implanted, tension
and elongation forces are imparted to the endoprosthesis. In
structures that do not have a telescopic joint or some other means
to relieve the stress developed by this tension, a considerable
amount of stress can be placed on the anchoring sites and/or the
attachment components, potentially allowing for dislodgement at the
anchoring sites or breakage of attachment components.
[0077] FIGS. 22, 23, 24 and 25 further illustrate a trunk component
101. It includes a common trunk portion 118 and a branched portion,
generally designated as 119. The branched portion includes the legs
109 and 113. In this embodiment, a further common trunk portion 120
is located opposite the other common trunk portion 118 and
extending from the branched portion 119. Thus, the overall
configuration of the trunk component is that of a double-lumen
length located between two single-lumen lengths. The common trunk
portion 118 can be positioned, for example, in the aortic artery,
the branched portion 119 provides a bifurcation structure to direct
blood flow into the two iliac arteries, and the further common
trunk portion 120 facilitates deployment of the leg components into
the branched portion 119, acting in the nature of a funnel for each
guidewire, introducer and contracted leg component.
[0078] Trunk component 101 includes a stent or tubular supporting
component 121. Also included is a liner, generally designated as
122. A further liner 123 preferably is located interiorly of the
liner 122. Liners 122, 123 are secured within the stent component
121 in order to provide proper porosity for an endoprosthesis.
[0079] Trunk component 101 includes one or more indents, such as
indent 124 and indent 125. A third, a fourth, or further indents
can be provided depending upon the degree of branching desired. It
will be appreciated that one or more tubular expandable supportive
leg graft components will be provided in order to slide into the
branched passageways which are thus defined by the indent(s). In
the illustrated embodiment, one such leg component 108 slidingly
engages an opening 126 of the trunk component leg 109, while a
second leg component 115 slidingly and expansively fits within
opening 127 of the leg component 115.
[0080] With particular reference to FIGS. 31-33, this shows a trunk
component 101c which has a function and a configuration along the
lines of trunk component 101, except only the liner defines the
indent or indents. In this arrangement, the tubular supporting
component is cylindrical in cross-section substantially throughout
its length.
[0081] FIG. 31 illustrates the trunk component 101c. It includes a
common trunk portion 118c and a branched portion, generally
designated as 119c. The bifurcated or branched portion includes the
legs 109c and 113c. In this embodiment, a further common trunk
portion 120c is located opposite the other common trunk portion
118c and extends from the branched or bifurcated portion 119c.
Thus, as with trunk component 101, the overall configuration of
trunk component 101c is that of a double-lumen length located
between two single-lumen lengths.
[0082] Trunk component 101c includes a stent or tubular supporting
component 121c, as perhaps best seen in FIG. 32. Also included is a
liner, generally designated as 122c. This liner 122c has a body
portion 123c and the legs 109c and 113c which open into another
body portion 151.
[0083] Each leg 109c, 113c is secured to the generally tubular
stent component 121c at outside portions thereof, particularly at
adhesion zones 124c and 125c. The remainder of the leg portions
109c and 113c are not so bonded to the stent portion 121c. This
facilitates formation of the leg portions, which are typically
pinched along the length of the legs in order to form at least one
internal seam 126c. Leg openings 127c and 128c are thereby
generally defined between this seam 126c and the adhesion zones
124c and 125c.
[0084] In FIG. 33, means are included in the trunk component 101d
which provides enhanced securement upon implantation. A stent
component 129d is included which has a substantially higher pitch
angle (for example, between about 140.degree. and 180.degree.) than
does the stent portion 121d therebelow within which the legs are
positioned (for example, at a pitch angle of between about
70.degree. and 90.degree.). This higher pitch angle zone imparts a
greater hoop strength upon deployment than does the stent 121c of
the trunk component 101c. A barb 130 is also shown in order to
further assist in securement of the endoprosthesis to the artery
wall. When desired, the barb-type of structure can be a backing
ring and barb formed out of the stent strand during its formation
into the cylindrical supportive member.
[0085] Any of the various expandable supportive endoluminal graft,
or stent graft, constructions discussed or referred to herein can
be used in order to construct devices in accordance with this
embodiment. Other modifications may also be incorporated, including
tubes having stepped diameters or conical ends. The stent component
can be made with flat wires or with pairs of wires or multifilament
wires. They can incorporate balloon expandable stents,
self-expanding stents, and combinations of balloon expandable
stents and self-expanding stents. Use can be made of ancillary
equipment such as endoluminal stapling devices or suturing devices
in order to facilitate securement at the aneurysm neck, for
example. Also, a portion of the stent component without a liner
component or the like thereon can project at the proximal end of
the endoluminal component, such as at a location which would be
above the renal arteries. The objective is also to help to secure
the device in place.
[0086] The prosthesis as discussed is deployed to replace or repair
tubular bodies such as blood vessels, tracheas, ureters and the
like, accommodating more than one conduit in order to divert flow
to other branches of the tubular body. This allows for repair of a
bifurcated area which is difficult to repair using a single-lumen
device or a plurality of individual single-lumen devices. It is
suitable for repair of damages to branched conduits or, conversely,
to repair conduits which converge into a single branch.
[0087] A preferred use for the bifurcating endoluminal grafts
discussed herein is for insertion into a branching blood vessel.
Same is typically suitable for use in the coronary vasculature (the
right, left common, left anterior descending, and circumflex
coronary arteries and their branches) and the peripheral
vasculature (branches of the carotid, aorta, femoral, popliteal
arteries and the like). These bifurcated devices are also suitable
for implantation into other branching vessels such as in the
gastrointestinal system, the tracheobronchial tree, the biliary
system, and the genitourinary system.
[0088] It will be appreciated that the expandable supportive grafts
in accordance with the present invention will dilate and/or support
blood vessel lesions and other defects or diseased areas, including
at or in proximity to sites of vascular bifurcations, branches
and/or anastomoses. The expandable supportive graft is an integral
structure that incorporates the expandable support component into
the wall or walls of the elastomeric graft. Covers and/or linings
that make up the grafts interface with body components that
facilitate normal cellular invasion without stenosis or recurrent
stenosis when the graft is in its expanded, supportive orientation.
The graft material is inert and biocompatible. The expandable
supportive graft can be expanded from a smaller diameter insertion
configuration to a larger diameter implantation configuration by
the application of radially outwardly directed forces provided by
expanding the endoprosthesis with a balloon catheter, using an
ejection tube that allows a spring-into-place structure to be
deployed from the end of a catheter into its expanded
configuration, or by using a support component made of certain
alloys exhibiting thermotransition characteristics by which they
expand when heated, for example.
[0089] In addition to the support component structures illustrated
herein, support structures include others having spring
characteristics and those having a coil with circumferentially
oriented fingers such as shown in Gianturco U.S. Pat. No.
4,800,882, incorporated by reference hereinto. U.S. Pat. Nos.
5,061,275, 5,219,355 and 5,336,500 relate to expanding or
self-expanding endoluminal devices. Typically, these devices center
on the use of a metallic structure imparting expansion attributes.
U.S. Pat. Nos. 4,994,071 and 5,360,443 describe bifurcated devices
which use expandable metallic stent structures and textile
materials allowing branching of fluid flow. In general, materials
of these patents, incorporated by reference hereinto, can be
utilized in constructing components of the present invention.
[0090] More specifically, the tubular supportive component
preferably is a braided tubular stent body made of metal alloy or
any other material that is flexible, while being rigid and
resilient when thus braided. Spring-type metals are typically
preferred, such as stainless steel, titanium, stainless steel
alloys, cobalt-chromium alloys, including alloys such as Elgiloy,
Phynox and Conichrome. Thermal transition or memory function alloys
such as nickel-titanium alloys including Nitinol are also suitable.
Malleable metals including tantalum would be especially suitable
for a structure that is not self-expanding.
[0091] Concerning the materials for the liner(s), they are
typically polymeric materials in the form of a membrane or
textile-like material, the objective being to reduce the porosity
of the stent for proper tissue ingrowth and fluid tightness.
Exemplary polymeric materials include polyesters such as
polyethylene terephthalate, polyolefins such as polypropylene, or
elastomeric materials such as polyurethane or silicone rubber.
Combinations of these materials are also possible. In an especially
preferred arrangement, the exterior liner which engages the tubular
supportive component 121, when provided, is made of a double tricot
polyester mesh knit, typically a Dacron type of material, while the
interior liner 122c is made of a polyurethane. In an especially
preferred arrangement, a thin coating or cover of polymer is
provided over the braided wires of the tubular supportive
component.
[0092] With further reference to the material out of which the
cover and/or liner of the grafts in accordance with the present
invention are made, the material must be stretchable with respect
to the support component so that it will follow the movement of the
endoprosthesis between its fully collapsed and expanded or
implanted configurations. Polyurethanes are preferred. Particularly
preferred is an especially crack-resistant, elastomeric and pliable
polycarbonate urethane as described in Pinchuk U.S. Pat. Nos.
5,133,742 and 5,229,431, incorporated by reference hereinto.
[0093] In addition, various surface treatments can be applied to
render the surfaces of the expandable supported graft more
biocompatible. Included are the use of pyrolytic carbon, hydrogels
and the like. The surface treatments can also provide for the
elution or immobilization of drugs such as heparin, antiplatelet
agents, antiplatelet-derived growth factors, antibiotics, steroids,
and the like. Additionally, the coating and/or liner can be loaded
with drugs such as those discussed herein, as well as lytic agents
in order to provide local drug therapy.
[0094] It will be noted that the indent(s) such as indents 124, 125
and the seams(s) such as internal seam 126c are longitudinally
disposed and generally define at least two leg portions, each with
a diameter less than the diameter of the main body. Each indent has
an internal longitudinal surface such as longitudinal edge 128,
129. These edges can be in contact with one another. If desired,
they can be secured together such as with sutures, adhesives,
wires, clips or the like (not shown). One or two such indents or
creases produce an asymmetrical or a symmetrical bifurcation as
desired. In another exemplary approach, three indents would form a
trifurcated device. Additional creases can be provided insofar as
is allowable by the braided wire mesh density and diameter.
[0095] Seam 126c can be formed by joining together two or more
longitudinal portions of the liner 122c. When two such longitudinal
portions are joined together, they are generally opposite to each
other. When three such longitudinal portions are joined together,
they are approximately 120.degree. from each other along the
circumference of the liner 122c, and three legs are formed. When
four such longitudinal portions are joined together, for example,
they are spaced approximately 90.degree. apart.
[0096] Whatever the number of indents or seams, the deformation of
the braided tubular body reduces the cross-sectional area from that
of the main trunk body to that of each branched area. The total
cross-sectional area of the branching tubular bodies should be
equal to or greater than 40% of the cross-sectional area of the
main trunk body. Preferably, this area should be greater than about
70% in order to prevent any significant pressure differences along
the device once deployed and implanted. For example, in a typical
human, the cross-sectional area of the abdominal aorta is reduced
by only about 20% when opening into the common iliac arteries.
[0097] FIG. 26 illustrates a fixture suitable for use in forming
the indent or indents as permanent deformations of the braided mesh
cylinder which is the tubular supportive component for this
embodiment. Fixture 131 in the configuration as illustrated is used
for shaping a symmetrical bifurcated design. The braided cylinder
is longitudinally compressed and placed over the mandrel 132, this
placement being generally shown in FIG. 27. End caps 133, 134 lock
the tubular supportive component 121 in its compressed state. Same
is then placed into the fixture 131, as generally shown in FIG. 26.
Slits 135 are positioned parallel to the longitudinal axis and on
opposite sides. This permits the slipping of blades 136, 137 into
the fixture 131 and thus into engagement with the tubular
supportive component. Edges 138, 139 of the blades then engage and
crease the tubular supportive component 121 between the blade edges
138, 139 and the troughs 141, 142 of the mandrel 132.
[0098] It will be appreciated that the length of the blade edges
138, 139 can be varied in order to create a desired length of
deformation on the main body of the trunk component. In addition,
branching areas thus formed can be made of different sizes by
varying the size of the individual cylindrical components of the
mandrel 132 so they are not identical as shown in FIG. 26. A larger
sized mandrel cylinder will result in the formation of a larger
trunk component leg 109, 113. This would typically also include
shifting the location of the slits 135 so that the plane of blade
insertion will line up with the troughs. It will be appreciated
that the trifurcated arrangement is achieved by a three-component
mandrel and three slits and blades that are 120.degree. apart.
Similarly, a four-branched structure would include four of each
features, spaced 90.degree. apart.
[0099] In a preferred arrangement for this embodiment, the thus
deformed braided tubular supportive component is chemically and
heat processed in order to set the desired diameter and mechanical
properties of the main body. Once this flexible metallic stent with
conformed shape is thus prepared, it is preferably lined as
discussed elsewhere herein. It will be noted that the illustrated
tubular braided mesh has a main cross-sectional area and has an
outward flair at both ends. The braided structure is advantageously
accommodated by the serrated structure of the blade edges 138, 139
in that the wire elements of the braid are grasped and secured at
the ends of the bifurcation.
[0100] The expandable supportive graft of the present invention is
capable of being tailored to meet specific needs, depending upon
the particular defect or disease being addressed, such as
occlusion, stenosis, aneurysm, arteriovenosis fistula, trauma and
the like, as well as upon the anatomy of the vessel. For example,
it can be desirable to have the support component of the expandable
supportive graft at locations other than throughout the entirety of
the graft as specifically illustrated in FIGS. 1 through 4 hereof.
The bifurcated graft of FIGS. 7 and 8 shows some separation along
the support component, such as between the trunk 61 and the
branches 62, 63. It is also possible, with the grafts in accordance
with the present invention, to provide an expandable graft having
its supportive property emanating from one or more support
components, while thereby providing an adjoining graft cylindrical
portion which is supported primarily by its close proximity to a
support component which can be presented at one end, both ends, or
spaced along the expandable supportive graft in accordance with the
invention.
[0101] Such a structure is generally illustrated in FIG. 5, wherein
an adjoining graft cylindrical portion 71 is positioned between a
first support component 72 and another or second support component
73. The expandable supportive graft in accordance with the present
invention provides the tailorability advantage of being able to
vary within a single graft the configuration, structure and
properties of the support component or components of the graft.
These various properties allow the expandable supportive graft to
be tailored in accordance with particular needs of the disease,
defect or damage being treated. For example, support may be
particularly desirable at one location being treated, while a less
rigid supportive area is needed at another, generally adjoining
location. By the expandable supportive graft in accordance with
this invention, a single graft can be deployed in order to effect
two or more different functions. By achieving multiple support
and/or repair functions with a single device, possible trauma to
the patient is minimized by reducing the number of transluminal
passages needed to address a situation that could otherwise require
separate stents or grafts, each of which is separately deployed or
implanted.
[0102] With further reference to the tailorability aspects, the
present invention reduces the risk of compromising the patency of
the passageways being treated. This is particularly true in
treating lesions at or near vascular bifurcations, branches and/or
anastomoses. Typical difficulties which can be avoided by the
present invention include displacing of diseased tissue, vessel
spasm, dissection with or without intimal flaps, thrombosis,
embolism, and the like. Another suitable use is for dilating and/or
supporting vascular graft bifurcations and the like. Additionally,
lesions affecting vascular trifurcations can be treated. Also
treatable are obstructed openings characterized by exaggerated
cicatrization, abnormal cellular growth (subintimal fibromuscular
hyperplasia and the like) or arterial or venous stenosis. Moreover,
these supportive grafts can be used to reinforce vascular walls,
weakened by pathological processes, for example, by dissection, as
in the case of aneurysms. The grafts can also obliterate congenital
or acquired arteriovenous communications, and they can be applied
in intrahepatic portal-caval shunts. The grafts also can maintain
biological pathways open, such as the digestive, biliary,
pancreatic and urinary tracts, and they help to limit the
intraluminal growth of pathological processes such as fibrosis or
cancer.
EXAMPLE I
[0103] This example illustrates the formation of a branched
expandable supportive endoluminal graft having an expanded internal
diameter of 10 mm and which is bifurcated to accommodate two
endoluminal supportive graft legs of 5 to 7 mm in diameter. A liner
of non-woven polycarbonate urethane (Corethane.RTM.) was spun by
winding over a mandrel, generally in accordance with U.S. Pat. No.
4,475,972. In this instance, the liner consisted of approximately
400 layers of fibers. A bifurcated braided mesh tubular supportive
component made in a fixture as illustrated in FIG. 26 was spray
coated using a dilute solution of polycarbonate urethane having a
hardness grade and a melting point lower than that used to spin the
liner. It was allowed to dry with warm air. Several spray coats
allow for the formation of an adhesive layer.
[0104] The previously prepared polycarbonate urethane liner was cut
to length and placed inside the adhesive-coated bifurcated braided
mesh and seated to closely fit the bifurcated braided mesh. A
mandrel having a shape similar to the inner configuration of the
bifurcated mesh was inserted from one end to act as a support.
Shrink tubing was slipped over portions of this assembly. This
assembly was heated to the melting point of the polycarbonate
urethane adhesive while allowing the shrink tubing to heat shrink
and compress the braided mesh against the liner which is supported
by the shaped mandrel. After cooling, the shrink tubing was removed
and the mandrel slipped out, leaving a completed trunk component as
described herein.
[0105] The two endoluminal tubular expandable supportive graft leg
components are prepared in accordance with a similar procedure
which is simpler because of the cylindrical shape of these
components.
EXAMPLE II
[0106] The procedure of Example I is substantially repeated, except
the liner is a double tricot polyester mesh net. In a similar
arrangement, a trunk component of the same structure was formed,
except prior to insertion of the supporting mandrel, a second,
innermost liner of polycarbonate urethane is positioned in order to
provide a double-lined branched component.
EXAMPLE III
[0107] The procedures of Example I and of Example II are generally
followed, except here the expanded inner diameter of the trunk
component is 25 mm, and the cylindrical leg endoluminal grafts are
12-15 mm in diameter.
EXAMPLE IV
[0108] A branched vascular expandable supportive endoluminal graft
was made using a 16 mm diameter, 12 cm long Wallstent.RTM. device
as the support component in the following manner. A grounded 16 mm
mandrel was rotated on a spinning machine at 500 RPM, and a
spinnerette with 30 orifices was reciprocated along the axis of the
mandrel at 13.8 inches/second while applying 40,000 volts to the
spinnerette. Polycarbonate urethane, in dimethyl acetamide solution
(45% solids) was extruded from the spinnerette at 0.123 ml/min, the
fibers coming onto the mandrel in random fashion to form a mat-like
structure having randomly shaped pores. The environment in the
spinning chamber was controlled such that sufficient solvent from
the urethane solution evaporated off during spinning to enable the
fibers to be bond to underlying fibers during each transverse of
the spinnerette. After 300 passes of the spinnerette, the spinning
procedure was stopped and the mandrel with the spun polycarbonate
urethane mat was removed from the machine and cured at 110.degree.
C. for 16 hours. The tubular mat still on the mandrel was trimmed
to the appropriate size and the Wallstent.RTM. device was sheathed
over the mesh and the ends taped down. Another 10 passes of
polycarbonate urethane were spun over the Wallstent.RTM. device,
and the fibers, while still wet, are immediately pressed through
the interstices of the Wallstent.RTM. device with a silicone rubber
sponge at selected longitudinal locations, such that the fibers
bond to the underlying fibers of the urethane mat, thereby
capturing the Wallstent.RTM. device within the urethane wall along
those longitudinal locations. The assembly is then cured for an
additional 3 hours at 110.degree. C., after which the assembly is
removed from the mandrel. The expandable supportive endoluminal
graft formed in this manner had the bulk of the urethane mesh on
the inside of the stent. The longitudinal locations which are not
secured to the stent are joined together to form a seam to define
two legs as generally shown in FIG. 31.
EXAMPLE V
[0109] A branched aortic expandable supportive endoluminal graft is
made in the following manner. An aortic trunk supportive
endoluminal graft is fabricated using a 16 mm diameter, 12 cm long
support component. First, a 16 mm mandrel is rotated on a spinning
machine at 500 rpm, and a spinnerette with 30 orifices reciprocated
along the axis of the mandrel at 13.8 inches/second. Polycarbonate
urethane, in dimethyl acetamide solution (45% solids) is extruded
from the spinnerette at 0.123 ml/min and wound onto the rotating
mandrel such that the fibers form a 50.degree. pitch angle in
relation to the axis of the mandrel. The environment in the
spinning chamber is controlled such that sufficient solvent from
the urethane solution evaporates off during spinning to enable the
fibers to bond to underlying fibers during each transverse of the
spinnerette. The formed spun polycarbonate urethane mesh has a
length of about 16 cm, is removed from the machine and is cured at
110.degree. C. for 16 hours. The support component is sheathed over
the mesh still on the mandrel. Another 10 passes of polycarbonate
urethane are spun over the tubular mesh, support component, but not
over the 4 cm excess length of the internal tubular mesh, and the
fibers, while still wet, are immediately pressed through the
interstices of the support component with a silicone rubber sponge,
such that the fibers bonded to the underlying fibers of the
urethane mesh, thereby capturing the support component within the
urethane wall. The assembly is then cured for an additional 3 hours
at 110.degree. C., after which the assembly is removed from the
mandrel. The supportive endoluminal graft formed in this manner has
fiber diameters of 10 to 20.mu. and pore sizes ranging from 10 to
60.mu.. The length of the tubular mesh which is spaced about 4 cm
from each side of the assembled endoprosthesis is then slit and
sewn down the center such that the tube is branched into two
smaller tubes along about 8 cm of the longitudinal central length
of the tubular mesh.
[0110] The aortic trunk endoprosthesis is pulled down and sheathed
on an introducer catheter, maneuvered into the aorta of a dog, via
the dog's femoral artery for deployment in the abdominal aorta. Two
smaller stents, of 8 mm diameter, are also pulled down onto
introducer catheters and maneuvered, through each femoral artery
for deployment into the seam-defined two smaller tubes or "legs" of
the aortic trunk. The resultant branched endoprosthesis is for
limiting further dilation of an abdominal-iliac aneurysm.
EXAMPLE VI
[0111] A branched expandable supportive endoluminal graft is
provided for deployment within and repair of aorto-iliac aneurysms.
A generally tubular metallic stent of the self-expandable type is
adhered to the outside of a porous spun liner as follows. The graft
is wound or spun from filaments deposited onto a rotating mandrel
in order to form a cylindrical graft having crossing strands
generally adhered together. The resulting inner liner, after it is
dried, has a stent component placed over it. Then, an area of the
stent is masked, such as with a piece of tape, at the location
where an internal seam is to be positioned in the trunk component
of the supportive endoluminal graft. The masking can take on a
shape on the order of the triangular areas illustrated in FIG. 32,
with the upper apex forming the upper "crotch" of the seam, and the
lower apex forming the lower "crotch" of the seam. Additional
fibers are then spun over the entire stent and pressed through the
stent intersticies to be certain that the stent is secured to the
liner. This continues until all areas of the stent are well-bonded
except for the masked areas. After removal of the mandrel and of
the masking material, the initially formed inner liner is free to
be pinched along its length and sutured, sewed and/or glued and the
like to form two distinct leg portions and a trunk portion of the
liner. The resulting trunk component is as generally shown in FIGS.
31 and 32.
[0112] The leg components of the branched supportive endoluminal
graft in accordance with this Example are individually made in a
similar manner. The liner is formed by spinning compliant fibers
over a rotating mandrel, a tubular stent component is positioned
thereover and secured in place, and additional fibers are wound
with the rotating mandrel. The stent is thus encapsulated between
the liner fibers and the cover fibers, preferably with the aid of a
soft roller or sponge to force the cover strands into the
interstices of the stent component and securement to the underlying
liner fibers. After removal from the mandrel, the resulting tubular
supported graft component, suitable for use as both the iliac
components, is trimmed to proper length.
EXAMPLE VII
[0113] A branched aortic expandable supportive endoluminal graft
was made using a liner of polycarbonate urethane. The cylindrical
liner was flattened, and a longitudinal seam was formed by heat
sealing together the flattened opposing portions along a thus
formed seal line. A self-expanding cylindrical stent-like support
component was coated on at least its inside surface with a
heat-activated adhesive. The seamed liner was inserted into the
stent-like support component, and the liner was inflated until the
two non-seamed portions of the liner and the radially extending
portions of the seamed portion of the liner engaged the inner
surface of the support component. Then, this assembly with the
inflated liner was placed into an oven to activate the adhesive
whereby, upon subsequent cooling, the seamed liner was secured to
the support component to form a branched trunk component as shown
in FIGS. 31 and 32. In this example, the inflation of the liner was
carried out by packing the seamed liner with salt crystals so the
liner stretches in place and until adhesion between the liner and
the support component had occurred.
EXAMPLE VIII
[0114] A branched trunk component is prepared as described in
Example VII, except the liner inflation is carried out by expanding
balloon activity, and the seam is formed by suturing. Because the
branched trunk component will elongate when collapsed for entry
into the delivery tool, the suturing allows for longitudinal
expansion and contraction back down to the as-manufactured seam
length. Such suturing is achieved by using a zig-zag stitch
pattern.
EXAMPLE IX
[0115] Another branched trunk component is made as described in
Example VIII, except the liner inflation is carried out by a
mandrel, and the sutured seam is formed with a polyurethane
compliant suture material.
[0116] It will be understood that the embodiments of the present
invention which have been described are illustrative of some of the
applications of the principles of the present invention. Various
modifications may be made by those skilled in the art without
departing from the true spirit and scope of the invention.
* * * * *