EP0938879A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Stent-graft assembly and method of manufacture
Assignee: Medtronic Vascular Inc
•
Filing: 1999-02-24
•
Granted: —
•
Expires: 2019-02-24
Abstract
Abstract A stent-graft assembly and method of preparing the same are disclosed. In a first embodiment, the assembly comprises a stent, a coating and a membrane, wherein the coating and membrane are bonded to one another at a plurality of bonding regions such that they define a unitary structure, thereby permanently adhering the coating and membrane to one another. A second embodiment of the stent-graft assembly comprises a stent, a coating and a porous membrane, wherein portions of the coating extend into the pores of the porous membrane to sealingly engage the membrane, again to achieve secure adhesion. In either embodiment, the stent-graft assembly may comprise an elastomeric coating substantially encapsulating the entire stent, and a membrane covering only the medial portion of the assembly. The diameter of the proximal and distal regions may thereby be variable over a wider range than the medial portion, enhancing conformity of the effective diameter of the assembly with the diameter of the body lumen and ensuring that the device will securely seat and seal within the body lumen. The proximal and distal regions of the stent-graft assembly may comprise an additional coating, whereby layers of material are sealed, thereby minimizing thrombogenic potential of free ends of the assembly. In any of the foregoing embodiments, the membrane may be a thin-walled tube, and the method of making such a tube is also disclosed.
Inventors
- 👤 Michael S. Williams
- 👤 John E. Nolting
- 👤 Matthew J. Birdsall
- 👤 Robert D. Lashinski
- 👤 Samuel L. Shull
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-23 23:38
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/04; A61F2/06; A61F2/07; A61F2/82; A61F2/86; A61F2/90; A61F2/91; A61F2002/072; A61F2250/00; A61F2250/0014; A61F2250/0023; A61F2250/0039; B; B29; B29C; B29C53/00; B29C53/36; B29C53/38; B29C53/56; B29C53/58; B29C53/60; B29L; B29L2023/00; B29L2023/005; B29L2023/007
Claims Analysis
Total Claims: 47
Claim 1
Independent Claim
89 words
A stent-graft assembly comprising: a generally cylindrical stent comprising at least one
support member, an exterior and an interior, a medial
region, a proximal region and a distal region, said at
least one support member defining a passageway through the
stent; a first coating substantially encapsulating at a
least a portion of the at least one support member; a first membrane, said membrane covering at least a
portion of at least one of said exterior and interior; and a plurality of bonding regions between the coating
and the membrane.
Claim 2
Dependent Claim
16 words
The stent-graft assembly of claim 1 wherein said
coating and said membrane define a unitary structure.
Claim 3
Dependent Claim
19 words
The stent-graft assembly of claim 1 wherein said
membrane comprises pores and wherein said coating extends
into said pores.
Claim 4
Dependent Claim
42 words
The stent-graft assembly of claim 1 wherein the
membrane covers substantially all of at least one of the
exterior or interior and the proximal and distal regions
further comprise a second coating substantially
encapsulating the assembly at the proximal and distal
regions.
Claim 5
Dependent Claim
48 words
The stent-graft assembly of claim 1, the interior
comprising a second coating at the proximal and distal
regions, the second coating substantially encapsulating at
least a portion of the at least one support member and at
least a portion of the membrane at the proximal and distal
regions.
Claim 6
Dependent Claim
38 words
The stent-graft assembly of claim 1 wherein the first
coating is elastomeric, the first membrane covers only the
medial region of the stent, and the assembly also
comprises a second elastomeric membrane at the proximal
and distal regions.
Claim 7
Dependent Claim
20 words
The stent-graft assembly of claim 6, wherein the
second membrane substantially encapsulates the assembly at
the proximal and distal regions.
Claim 8
Dependent Claim
39 words
The stent-graft assembly of claim 6, said stent
comprising an expanded configuration wherein said medial
region comprises a first diameter; and said proximal and distal regions comprise a diameter
which is greater than the diameter of the medial region.
Claim 9
Independent Claim
108 words
A method of forming a stent-graft assembly, the method
comprising the steps of: providing a generally cylindrical stent having an
interior and an exterior, first and second ends and at
least one support member; coating at least a portion of the at least one
support member with a coating to substantially encapsulate
at least a portion of the at least one support member; providing at least one membrane; placing said at least one membrane contiguous with at
least a portion of at least one of the exterior and
interior of the stent; introducing a solvent in order to bond the membrane
to the coating; and removing the solvent.
Claim 10
Dependent Claim
22 words
The method of claim 9 wherein the step of coating the
stent is performed by spraying a polymeric solution onto
the stent.
Claim 11
Dependent Claim
17 words
The method of claim 9 wherein the step of coating the
stent comprises a vapor deposition process.
Claim 12
Dependent Claim
20 words
The method of claim 9 wherein the step of coating the
stent comprises dipping the stent into a polymeric
solution.
Claim 13
Dependent Claim
53 words
The method of claim 9 wherein the step of coating the
stent comprises: mounting an end of the stent on a
rotating mandrel; heating the stent; spraying the rotating stent with polymer in solution;
curing the stent; alternating the end of the stent that is mounted on the
mandrel; repeating the foregoing steps.
Claim 14
Dependent Claim
36 words
The method of claim 9 wherein the stent-graft
assembly also comprises a medial region, a proximal region
and a distal region, with the additional step of coating
the proximal and distal regions of the stent-graft
assembly.
Claim 15
Dependent Claim
15 words
The method of claim 9 wherein the coating and the
membrane comprise chemically similar materials.
Claim 16
Dependent Claim
39 words
The method of claim 14 wherein the first membrane is
placed to cover only the medial region of the exterior of
the stent, and a second elastomeric membrane is placed
over the proximal and distal regions of the assembly.
Claim 17
Dependent Claim
30 words
The method of claim 14 wherein the step of coating
the distal and proximal regions comprises dipping the
proximal and distal regions of the assembly into a polymer
in solution.
Claim 18
Dependent Claim
84 words
The method according to claim 9 with the additional
steps of preparing the at least one membrane, wherein said
steps comprise: preparing at least one tube by first providing a
polymeric tape of less than 0.010 inch thickness; winding the polymeric tape helically around at least
a portion of the length of the mandrel in overlapping
fashion; and placing the wrapped mandrel in an oven at a
sufficient temperature and for a sufficient time to
achieve sintering of the overlapping portions of the tape.
Claim 19
Dependent Claim
41 words
The method according to claim 18 wherein the tape
comprises a width and a plurality of edges, wherein the
tape is wound around the mandrel such that adjacent edges
of tape overlap 10-60 per cent of the width of the tape.
Claim 20
Dependent Claim
33 words
The method according to claim 18 wherein the tape is
wound about the mandrel at an angle to the longitudinal
axis of the mandrel, wherein the angle is between 30 and
60 degrees.
Claim 21
Dependent Claim
21 words
The method according to claim 18 wherein the wrapped
mandrel is heated in an oven for between 30 and 45
minutes.
Claim 22
Dependent Claim
23 words
The method according to claim 9 wherein the step of
introducing a solvent comprises placing the assembly
within a super-saturated atmosphere of solvent.
Claim 23
Dependent Claim
148 words
A stent-graft assembly comprising: a generally cylindrical stent having a proximal
region and a distal region and comprising at least one
support member, and at least one interstice, an exterior
and an interior, said at least one support member defining
a passageway through the stent; a first membrane, said membrane contiguous with at
least a portion of the interior of the stent to define a
luminal surface; a second membrane, said membrane covering at least a
portion of the exterior of the stent to define a vascular
surface, said first and second membrane bound to one
another through at least one interstice of the stent; and the assembly further comprising a proximal region and
a distal region, said proximal and distal regions
comprising a first coating on at least a portion of said
proximal region and a second coating on at least a portion
of said distal region.
Claim 24
Dependent Claim
32 words
A stent-graft assembly according to claim 23 wherein
the first and second coating substantially encapsulates
the first and second membranes and the support member or
members at the proximal and distal regions.
Claim 25
Dependent Claim
18 words
The stent-graft assembly according to claim 23
wherein the first and second membrane are sintered to one
another.
Claim 26
Independent Claim
71 words
A method for preparing a stent-graft assembly, the
method comprising the steps of: lining at least a portion of the interior of a stent
with a membrane, said stent comprising at least one
interstice, a proximal region and a distal region; placing a membrane over at least a portion of the
exterior of a stent; sintering the membranes to one another; dipping the proximal and distal regions into a
polymeric solution.
Claim 27
Dependent Claim
94 words
A stent-graft assembly comprising: a generally cylindrical stent comprising at least one
support member, an exterior and an interior, a medial
region, a proximal region and a distal region, said at
least one support member defining a passageway through the
stent; at least one membrane, said at least one membrane
affixed to at least a portion of at least one of said
interior and exterior, wherein the at least one membrane
defines at least one of a luminal surface and a vascular
surface, said at least one membrane being less than 0.040
inch thick.
Claim 28
Dependent Claim
16 words
The stent-graft assembly according to claim 27
wherein the membrane is less than 0.0016 inch thick.
Claim 29
Dependent Claim
18 words
The stent-graft assembly according to claim 27
wherein the at least one membrane is of generally uniform
thickness.
Claim 30
Dependent Claim
40 words
The stent-graft assembly according to claim 27
wherein the stent further comprises: a first polymeric coating substantially encapsulating
at least a portion of the at least one support member; and the at least one membrane is affixed to the coating.
Claim 31
Dependent Claim
25 words
The stent-graft assembly according to claim 30
wherein the at least one membrane is porous and the
coating extends into the pores of the membrane.
Claim 32
Dependent Claim
20 words
The stent-graft assembly according to claim 30
wherein the at least one membrane and the coating form a
unitary structure.
Claim 33
Dependent Claim
52 words
The stent-graft assembly according to claim 27
wherein the stent comprises at least one interstice, and
the assembly further comprises a first inner membrane
defining a luminal surface and a second outer membrane
defining a vascular surface, wherein the first and second
membranes are bound together through the at least one
interstice.
Claim 34
Dependent Claim
17 words
The stent-graft assembly according to claim 33
wherein the first membrane is sintered to the second
membrane.
Claim 35
Dependent Claim
30 words
The stent-graft assembly of claims 1, 23 or 27
wherein the membrane is a polymer selected from the group
consisting of polyurethane, ePTFE, dimethyl terephthalate,
polyester, polyethylene terephthalate and silicone.
Claim 36
Dependent Claim
27 words
The stent-graft assembly of claims 1, 23 or 27
wherein the coating is a polymer selected from the group
consisting of polyurethane, flourinated ethylene propylene
and silicone.
Claim 37
Dependent Claim
22 words
The stent-graft assembly of claims 1, 23 or 27
wherein the membrane or the coating also comprises at
least one therapeutic agent.
Claim 38
Dependent Claim
19 words
The stent-graft assembly of claims 1, 23 or 27
wherein the assembly also comprises at least one
radiopaque marker.
Claim 39
Dependent Claim
34 words
The stent-graft assembly of claims 1, 23 or 27
wherein the membrane comprises a primary diameter and
wherein the membrane is distensible over a range of
between 7 and 100% beyond the primary diameter.
Claim 40
Independent Claim
162 words
A method for preparing a stent-graft assembly, the
method comprising the steps of: providing a polymeric tape of less than 0.010 inch
thickness; helically winding the tape about a mandrel in
overlapping fashion; heating the wrapped mandrel at sufficient temperature
for sufficient time to achieve sintering of the
overlapping portions of the tape to prepare a first thin-walled
membrane; removing the tube from the mandrel; repeating the foregoing steps to prepare a second
thin-walled membrane; providing a generally cylindrical stent having an
interior and an exterior, a proximal region and a distal
region, at least one interstice and at least one support
member; lining at least a portion of the interior of the
stent with the first membrane to define a luminal surface; placing the second membrane over at least a portion
of the exterior of the stent to define a vascular surface;
and bonding the first and second membranes to one another
through the at least one interstice of the stent.
Claim 41
Dependent Claim
24 words
The method according to claim 40 with the added step
of dipping the proximal and distal regions of the assembly
into a polymeric solution.
Claim 42
Dependent Claim
43 words
The method according to claim 40 wherein the step of
bonding the first membrane to the second membrane
comprises heating the assembly for sufficient time at
sufficient temperature to achieve sintering of the
membranes to one another through the at least one
interstice.
Claim 43
Independent Claim
65 words
A method for preparing a thin-walled graft tube, the
method comprising the steps of: providing a polymeric tape of less than 0.010 inch
thickness; helically winding the tape about a mandrel in
overlapping fashion; applying pressure to the wrapped mandrel; and heating the wrapped mandrel under pressure at a
sufficient temperature for a sufficient time to achieve
sintering of the overlapping portions of the tape.
Claim 44
Independent Claim
26 words
The method of claims 9, 15 or 30 wherein the coating
is a polymer selected from the group consisting of
polyurethane, silicone and flourinated ethylene propylene.
Claim 45
Independent Claim
32 words
The method of claims 9, 16, 18 or 26 wherein the
membrane is a polymer selected from the group consisting
of ePTFE, polyurethane, dimethyl terephthalate, polyester,
polyethylene terephthalate, polyethylene terephthalate and
silicone.
Claim 46
Independent Claim
20 words
The method of claims 9, 31 or 40 wherein the coating
or the membrane comprises at least one therapeutic agent.
Claim 47
Independent Claim
23 words
The method of claims 9, 27 or 40 with the additional
step of adding a radiopaque marker to the coating or the
membrane.
References Cited (Backward Citations)
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