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Self-expandable stent and stent-graft and method of using them

Assignee: Gore Enterprise Holdings Inc
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Filing: 1995-04-03
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Granted: —
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Expires: 2015-04-03
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Abstract

Abstract The device is a foldable stent (122) or stent-graft (370) which may be delivered with (or on) a catheter or via surgical or other suitable techniques. The device is then expanded or unfolded. The expandable stent structure preferably utilizes at least one torsional member (100) generally aligned with the longitudinal axis of the stent (122). The stent (122) preferably has an undulating shape. It may be helically deployed to form the generally cylindrical shape eventually deployed as the stent (122) or it may be formed of one or more rings (302). The structure desirably is aligned to allow those undulating shapes in adjacent rings (322) or turns of the helix to be in phase. The adjacent undulating shapes may be held in that phased relationship using a flexible linkage often made of a polymeric material. The stent (122) is self-expanding, kink-resistant, easily bent along its longitudinal axis, does not change its length during that expansion, and is able to provide collapsible support for otherwise frangible graft material. The graft component (134) cooperating with the stent (122) is tubular and may be biocompatible polymeric or collagenous material or combinations of the two which may, if desired, be reinforced with fibers.

Inventors

  • 👤 Lilip Lau
  • 👤 Charles T. Maroney
  • 👤 William M. Hartigan
  • 👤 Sharon Lam
  • 👤 Kimberley A. Mccullough
  • 👤 Woonza Rhee

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-24 09:57
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/82; A61F2/86; A61F2/88; A61F2/844; A61F2/856; A61F2/90; A61F2/91; A61F2/915; A61F2/92; A61F2/02; A61F2/04; A61F2/06; A61F2/07; A61F2/89; A61F2/95; A61F2/954; A61F2002/075; A61F2/30; A61F2002/30001; A61F2002/30003; A61F2002/3006; A61F2002/3008; A61F2002/30092; A61F2002/30316; A61F2002/30329; A61F2002/30462; A61F2002/9155; A61F2002/91558; A61F2002/91575; A61F2210/00; A61F2210/0014; A61F2210/0019; A61F2210/0076; A61F2220/00; A61F2220/0025; A61F2220/0058; A61F2220/0075; A61F2230/00; A61F2230/0002; A61F2230/0028; A61F2230/0039; A61F2230/0041; A61F2230/006; A61F2230/0063; A61F2230/0073; A61F2230/0078; A61F2250/00; A61F2250/0058; A61F2250/0096; A61F2250/0098; A61F2310/00; A61F2310/00005; A61F2310/00011; A61F2310/00017; A61F2310/00023; A61F2310/00029; A61F2310/00035; A61F2310/00137; A61F2310/00149

Claims Analysis

Total Claims: 50
Claim 1
Independent Claim 52 words
A device comprising: a folded, self-expanding stent, said stent having an unfolded tubular configuration and a deployable, folded configuration, said folded stent having at least one longitudinal fold edge; and a releasing line extending through and along said at least one longitudinal fold edge to maintain said stent in said folded configuration.
Claim 2
Dependent Claim 12 words
The device of claim 1, wherein said stent comprises a superelastic material.
Claim 3
Dependent Claim 12 words
The device of claim 1, wherein said stent comprises a nickel-titanium alloy.
Claim 4
Dependent Claim 11 words
The device of claim 3, wherein said nickel-titanium alloy is nitinol.
Claim 5
Dependent Claim 12 words
The device of claim 1, wherein said stent comprises a sheet metal.
Claim 6
Dependent Claim 12 words
The device of claim 1, wherein said stent comprises a wire material.
Claim 7
Dependent Claim 12 words
The device of claim 1, wherein said stent is produced from tubing.
Claim 8
Independent Claim 26 words
The device of any one of claims 1 to 7, further comprising at least one tubular graft member coupled to and generally coaxial with said stent.
Claim 9
Independent Claim 24 words
The device of any one of claims 1 to 7, wherein a single graft member is present and is coaxially disposed within said stent.
Claim 10
Dependent Claim 13 words
The device of claim 9, wherein the tubular graft member comprises a polymer.
Claim 11
Dependent Claim 11 words
The device of claim 10, wherein the polymer comprises a fluoropolymer.
Claim 12
Dependent Claim 11 words
The device of claim 11, wherein the fluoropolymer comprises expanded polytetrafluoroethylene.
Claim 13
Dependent Claim 13 words
The device of claim 9, wherein said graft member comprises a nonthrombogenic material.
Claim 14
Independent Claim 19 words
The device of any one of claims 9 to 13, further comprising reinforcing fibers within said tubular graft member.
Claim 15
Independent Claim 19 words
The device of any one of claims 9 to 14, further comprising radiopaque markers within said tubular graft member.
Claim 16
Independent Claim 35 words
The device from any one of claims 1 to 15, wherein said stent is formed from at least one undulating shaped member that circumferentially extends around a longitudinal axis and forms said tubular folded configuration.
Claim 17
Dependent Claim 14 words
The device of claim 16, wherein said at least one member contains multiple undulations.
Claim 18
Independent Claim 28 words
The device of any one of claims 1 to 17, wherein said stent is formed from a plurality of undulating shaped members in the shape of a ring.
Claim 19
Dependent Claim 17 words
The device of claim 18, further including a tie member interconnecting undulations of said undulating shaped members.
Claim 20
Independent Claim 21 words
The device of any one of claims 1 to 19, wherein said stent is releasably constrained in a spiral-shaped folded configuration.
Claim 21
Independent Claim 27 words
The device of any of claims 1 to 20, wherein said at least one longitudinal fold edge is approximately parallel to a longitudinal axis of said stent.
Claim 22
Independent Claim 18 words
The device of any one of claims 1 to 21, wherein said releasing line is a tether line.
Claim 23
Independent Claim 44 words
A method for preparing self-expanding stent comprising: folding self-expanding stent along a longitudinal axis to form at least one fold edge; and introducing a removable line into said stent along said at least one fold edge to maintain the stent in a folded condition.
Claim 24
Dependent Claim 17 words
The method of claim 23, wherein the self-expanding stent includes loops through which the line is introduced.
Claim 25
Dependent Claim 40 words
The method of claim 23 or 24, wherein the removable line is woven into the stent using a sack knot so as to allow removal of the line by unweaving the sack knot through axial movement of the slip line.
Claim 26
Independent Claim 14 words
The method of any of claims 23 to 25, wherein the stent is metallic.
Claim 27
Independent Claim 17 words
The method of any one of claims 23 to 26, wherein the stent comprises a superelastic alloy.
Claim 28
Independent Claim 17 words
The method of any one of claims 23 to 27, wherein the stent comprises a nickel-titanium alloy.
Claim 29
Independent Claim 23 words
The method of any one of claims 23 to 28, wherein the stent comprises a helically positioned undulating shaped member having multiple turns.
Claim 30
Dependent Claim 31 words
The method of claim 29, wherein the stent additionally comprises at least one flexible link passing through undulations of said undulating member to maintain the undulations in adjacent turns in alignment.
Claim 31
Independent Claim 33 words
The method of any one of claims 23 to 30 wherein the stent comprises a plurality of ring assemblies extending circumferentially about a longitudinal axis, each ring assembly containing a plurality of undulations.
Claim 32
Independent Claim 18 words
The method of any one of claims 23 to 31, further comprising a graft attached to the stent.
Claim 33
Dependent Claim 12 words
The method of claim 32, wherein the graft comprises a polymeric material.
Claim 34
Dependent Claim 12 words
The method of claim 32, wherein the graft comprises a fluoropolymer material.
Claim 35
Dependent Claim 12 words
The method of claim 32, wherein the graft comprises a collagen-based material.
Claim 36
Independent Claim 20 words
The method of any one of claims 32 to 35, wherein the graft comprises reinforcing fibers within said tubular member.
Claim 37
Independent Claim 21 words
The method of any one of claims 32 to 36, wherein the graft additionally comprises radiopaque markers within said tubular member.
Claim 38
Independent Claim 58 words
A method for introducing a self-expanding stent into a lumen, comprising the steps of: providing a folded, self-expanding stent, releasably restrained along at least one longitudinal edge; introducing said folded, self-expanding stent to a selected site in the lumen; axially releasing the folded, self-expanding stent in the lumen to allow the stent to expand at the selected site.
Claim 39
Dependent Claim 13 words
The method of claim 38, wherein the selected site is a vascular site.
Claim 40
Dependent Claim 28 words
The method of claim 38 or 39, wherein the stent is maintained in a folded condition prior to release by a removal slip line associated with said edge.
Claim 41
Dependent Claim 26 words
The method of claim 40, wherein the self-expanding stent includes loops along said at least one edge in the stent through which the slipline in introduced.
Claim 42
Dependent Claim 37 words
The method of claim 40, wherein the removable line is woven into the stent using a sack knot so as to allow removal of the line by unweaving the sack knot through axial movement of the line.
Claim 43
Independent Claim 15 words
The method of any one of claims 38 to 42, wherein the stent is metallic.
Claim 44
Dependent Claim 12 words
The method of claim 43, wherein the stent comprises a super-elastic alloy.
Claim 45
Dependent Claim 13 words
The method of claim 43, wherein the stent comprises a titanium nickel alloy.
Claim 46
Independent Claim 23 words
The method of any one of claims 38 to 45, wherein the stent comprises at least one helically positioned undulating member having undulations.
Claim 47
Dependent Claim 28 words
The method of claim 46, where the stent additionally comprises at least one flexible link passing through undulations of said undulating member and maintaining said undulations in alignment.
Claim 48
Independent Claim 18 words
The method of any one of claims 38 to 47, further comprising a graft attached to the stent.
Claim 49
Dependent Claim 13 words
The method of claim 48, wherein the stent graft comprises a polymeric material.
Claim 50
Dependent Claim 11 words
The method of claim 48, wherein the graft comprises a fluoropolymer.

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