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US20020040236A1 Expired / Lapsed US ⏱️ 0.0 years remaining

Procedures for introducing stents and stent-grafts

Assignee: W.L. Gore and Associates Inc
•
Filing: 1997-07-18
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Granted: —
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Expires: 2017-07-18
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Abstract

Abstract This invention is a medical device and a method of using it. The device is a foldable stent or stent-graft which may be percutaneously delivered with (or on) a catheter, typically an endovascular catheter, to a body cavity or lumen and then expanded. It may also be delivered or via surgical (or other) techniques. The expandable stent structure utilizes torsional members which distribute bending and folding loads in such a way that the stent is not plastically deformed. The stent's configuration allows it to be folded or otherwise compressed to a very small diameter prior to deployment without changing the length of the stent. The graft component cooperating with the stent is tubular and preferably is blood-compatible material which may, if desired, be reinforced with fibers. The stent is able to provide collapsible support for otherwise frangible graft material. The invention also involves procedures for folding stents and for deploying stents or stent-grafts which have been folded, bound, or otherwise collapsed to significantly smaller diameters for insertion into a human or animal body. When used with super-elastic alloys, the stent may be collapsed at a convenient temperature either above or, preferably, below the transition temperature of the alloy. The deployment procedures may involve the use of an outer sleeve to maintain the stent or stent-graft at a reduced diameter or may involve one or more external or internal “slip-lines” or “tether wires” to hold and then to release the device.

Inventors

  • 👤 Lilip Lau
  • 👤 Charles T. Maroney
  • 👤 William M. Hartigan
  • 👤 Sharon Lam

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 04:08
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/82; A61F2/86; A61F2/88; A61F2/02; A61F2/04; A61F2/06; A61F2/07; A61F2/844; A61F2/90; A61F2/91; A61F2/915; A61F2/92; A61F2/89; A61F2/95; A61F2002/061; A61F2002/072; A61F2002/075; A61F2/30; A61F2002/30001; A61F2002/30003; A61F2002/3006; A61F2002/3008; A61F2002/30092; A61F2002/30316; A61F2002/30329; A61F2002/30462; A61F2002/828; A61F2002/91508; A61F2002/91516; A61F2002/91533; A61F2002/9155; A61F2002/91558; A61F2002/91575; A61F2002/9505; A61F2002/9511; A61F2/962; A61F2/966; A61F2002/9665; A61F2210/00; A61F2210/0014; A61F2210/0019; A61F2220/00; A61F2220/0025; 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: 60
Claim 1
Independent Claim 70 words
1 . A method for preparing a self-expanding stent having two ends, a longitudinal axis between those ends, a passageway between those ends, torsion members having a component approximately parallel to said longitudinal axis, said torsion members storing and releasably restoring angular torsion upon flexing of the stent for introduction into a human body comprising: folding said self-expanding stent along the longitudinal axis to form at least one fold line.
Claim 2
Dependent Claim 70 words
1 . A method for preparing a self-expanding stent having two ends, a longitudinal axis between those ends, a passageway between those ends, torsion members having a component approximately parallel to said longitudinal axis, said torsion members storing and releasably restoring angular torsion upon flexing of the stent for introduction into a human body comprising: folding said self-expanding stent along the longitudinal axis to form at least one fold line.
Claim 3
Dependent Claim 28 words
2 . The method of claim 1 further including the step of introducing a removable slip line into the stent to maintain the stent in a folded condition.
Claim 4
Dependent Claim 30 words
3 . The method of claim 2 in which the self-expanding stent comprises loops along at least one fold line in the stent through which the slip line is introduced.
Claim 5
Dependent Claim 46 words
4 . The method of claim 2 in which the removable slip line is woven into the stent at a fold line using a sack knot so to allow removal of the slip line by unweaving the sack knot through axial movement of the slip line.
Claim 6
Dependent Claim 13 words
5 . The method of claim 1 in which the stent is metallic.
Claim 7
Dependent Claim 15 words
6 . The method of claim 1 in which the stent is a super-elastic alloy.
Claim 8
Dependent Claim 13 words
7 . The method of claim 1 in which the stent is nitinol.
Claim 9
Dependent Claim 24 words
8 . The method of claim 1 where the stent comprises at least one helically aligned torsion member having undulating elements defining said passageway.
Claim 10
Dependent Claim 36 words
9 . The method of claim 8 where the stent additionally comprises at least one flexible link passing through said helically aligned torsion member and maintaining said at least one helically aligned torsion member in alignment.
Claim 11
Dependent Claim 26 words
10 . The method of claim 8 where the stent additionally comprises at least one flexible link passing through said undulating elements on adjacent helical turns.
Claim 12
Dependent Claim 22 words
11 . The method of claim 9 where said undulating elements are arranged in an intercooperating phased relationship between adjacent helical turns.
Claim 13
Dependent Claim 22 words
12 . The method of claim 11 where said flexible link maintains said undulating elements in phased relationship between adjacent helical turns.
Claim 14
Dependent Claim 53 words
13 . The method of claim 1 where the stent comprises at least one ring assembly extending circumferentially about said passageway, said ring assembly containing at least one torsion member approximately parallel to said axis, said torsion member being situated so that when said ring assembly is distorted, said torsion member is twisted.
Claim 15
Dependent Claim 15 words
14 . The method of claim 1 further comprising a graft attached to the stent.
Claim 16
Dependent Claim 16 words
15 . The method of claim 14 in which the graft is a polymeric nonthrombogenic material.
Claim 17
Dependent Claim 22 words
16 . The method of claim 14 where the graft comprises a material selected from DACRON, TEFLON, KEVLAR, GORETEX, and porous polyurethane.
Claim 18
Dependent Claim 14 words
17 . The method of claim 14 where the graft comprises a collagen-based material.
Claim 19
Dependent Claim 18 words
18 . The method of claim 14 where the graft additionally comprises reinforcing fibers within said tubular member.
Claim 20
Dependent Claim 19 words
19 . The method of claim 14 where the tubular member additionally comprises radiopaque fibers within said tubular member.
Claim 21
Dependent Claim 106 words
20 . A method for the introduction into a human body of a self-expanding stent having two ends, a longitudinal axis between those ends, a passageway between those ends, torsion members having a component approximately parallel to said longitudinal axis, said torsion members storing and releasably restoring angular torsion upon flexing of the stent, which stent has been folded along said longitudinal axis to form one or more fold lines, comprising the steps of: introducing said folded self-expanding stent to a selected site in a human body, releasing the folded self-expanding stent so to allow the stent-graft to expand at the selected site in the body.
Claim 22
Dependent Claim 106 words
20 . A method for the introduction into a human body of a self-expanding stent having two ends, a longitudinal axis between those ends, a passageway between those ends, torsion members having a component approximately parallel to said longitudinal axis, said torsion members storing and releasably restoring angular torsion upon flexing of the stent, which stent has been folded along said longitudinal axis to form one or more fold lines, comprising the steps of: introducing said folded self-expanding stent to a selected site in a human body, releasing the folded self-expanding stent so to allow the stent-graft to expand at the selected site in the body.
Claim 23
Dependent Claim 16 words
21 . The method of claim 20 in which the selected site is a vascular site.
Claim 24
Dependent Claim 24 words
22 . The method of claim 20 wherein the stent is maintained in a folded condition prior to release by a removable slip line.
Claim 25
Dependent Claim 30 words
23 . The method of claim 20 in which the self-expanding stent comprises loops along at least one fold line in the stent through which the slip line is introduced.
Claim 26
Dependent Claim 46 words
24 . The method of claim 22 in which the removable slip line is woven into the stent at a fold line using a sack knot so to allow removal of the slip line by unweaving the sack knot through axial movement of the slip line.
Claim 27
Dependent Claim 13 words
25 . The method of claim 20 in which the stent is metallic.
Claim 28
Dependent Claim 15 words
26 . The method of claim 20 in which the stent is a super-elastic alloy.
Claim 29
Dependent Claim 13 words
27 . The method of claim 20 in which the stent is nitinol.
Claim 30
Dependent Claim 24 words
28 . The method of claim 20 where the stent comprises at least one helically aligned torsion member having undulating elements defining said passageway.
Claim 31
Dependent Claim 36 words
29 . The method of claim 28 where the stent additionally comprises at least one flexible link passing through said helically aligned torsion member and maintaining said at least one helically aligned torsion member in alignment.
Claim 32
Dependent Claim 26 words
30 . The method of claim 28 where the stent additionally comprises at least one flexible link passing through said undulating elements on adjacent helical turns.
Claim 33
Dependent Claim 22 words
31 . The method of claim 28 where said undulating elements are arranged in an intercooperating phased relationship between adjacent helical turns.
Claim 34
Dependent Claim 22 words
32 . The method of claim 30 where said flexible link maintains said undulating elements in phased relationship between adjacent helical turns.
Claim 35
Dependent Claim 53 words
33 . The method of claim 20 where the stent comprises at least one ring assembly extending circumferentially about said passageway, said ring assembly containing at least one torsion member approximately parallel to said axis, said torsion member being situated so that when said ring assembly is distorted, said torsion member is twisted.
Claim 36
Dependent Claim 15 words
34 . The method of claim 20 further comprising a graft attached to the stent.
Claim 37
Dependent Claim 16 words
35 . The method of claim 34 in which the graft is a polymeric nonthrombogenic material.
Claim 38
Dependent Claim 22 words
36 . The method of claim 34 where the graft comprises a material selected from DACRON, TEFLON, KEVLAR, GORETEX, and porous polyurethane.
Claim 39
Dependent Claim 14 words
37 . The method of claim 34 where the graft comprises a collagen-based material.
Claim 40
Dependent Claim 18 words
38 . The method of claim 34 where the graft additionally comprise reinforcing fibers within said tubular member.
Claim 41
Dependent Claim 19 words
39 . The method of claim 34 where the tubular member additioally comprises radiopaque fibers within said tubular member.
Claim 42
Dependent Claim 94 words
40 . A prosthetic device for introduction into the human body comprising: a.) a self-expanding stent suitable for introduction into the body, said stent having two ends, a longitudinal axis between those ends, a passageway between those ends, torsion members having a component approximately parallel to said longitudinal axis, said torsion members storing and releasably restoring angular torsion upon flexing of the stent and wherein the stent is folded along the longitudinal axis to form at least one fold line, and b.) a removable slip line holding said at least one fold line closed.
Claim 43
Dependent Claim 94 words
40 . A prosthetic device for introduction into the human body comprising: a.) a self-expanding stent suitable for introduction into the body, said stent having two ends, a longitudinal axis between those ends, a passageway between those ends, torsion members having a component approximately parallel to said longitudinal axis, said torsion members storing and releasably restoring angular torsion upon flexing of the stent and wherein the stent is folded along the longitudinal axis to form at least one fold line, and b.) a removable slip line holding said at least one fold line closed.
Claim 44
Dependent Claim 30 words
41 . The device of claim 40 in which the self-expanding stent comprises loops along at least one fold line in the stent through which the slip line is introduced.
Claim 45
Dependent Claim 46 words
42 . The device of claim 40 in which the removable slip line is woven into the stent at a fold line using a sack knot so to allow removal of the slip line by unweaving the sack knot through axial movement of the slip line.
Claim 46
Dependent Claim 13 words
43 . The device of claim 40 in which the stent is metallic.
Claim 47
Dependent Claim 15 words
44 . The device of claim 40 in which the stent is a super-elastic alloy.
Claim 48
Dependent Claim 13 words
45 . The device of claim 40 in which the stent is nitinol.
Claim 49
Dependent Claim 24 words
46 . The device of claim 40 where the stent comprises at least one helically aligned torsion member having undulating elements defining said passageway.
Claim 50
Dependent Claim 36 words
47 . The device of claim 46 where the stent additionally comprises at least one flexible link passing through said helically aligned torsion member and maintaining said at least one helically aligned torsion member in alignment.
Claim 51
Dependent Claim 26 words
48 . The device of claim 46 where the stent additionally comprises at least one flexible link passing through said undulating elements on adjacent helical turns.
Claim 52
Dependent Claim 22 words
49 . The device of claim 46 where said undulating elements are arranged in an intercooperating phased relationship between adjacent helical turns.
Claim 53
Dependent Claim 22 words
50 . The device of claim 48 where said flexible link maintains said undulating elements in phased relationship between adjacent helical turns.
Claim 54
Dependent Claim 54 words
51 . The device of claim 40 where the stent comprises at least one ring assembly extending circumferentially about said passageway, said ring assembly containing at least one torsion member a approximately parallel to said axis, said torsion member being situated so that when said ring assembly is distorted, said torsion member is twisted.
Claim 55
Dependent Claim 15 words
52 . The device of claim 40 further comprising a graft attached to the stent.
Claim 56
Dependent Claim 16 words
53 . The device of claim 52 in which the graft is a polymeric nonthrombogenic material.
Claim 57
Dependent Claim 22 words
54 . The device of claim 52 where the graft comprises a material selected from DACRON, TEFLON, KEVLAR, GORETEX, and porous polyurethane.
Claim 58
Dependent Claim 14 words
55 . The device of claim 52 where the graft comprises a collagen-based material.
Claim 59
Dependent Claim 18 words
56 . The device of claim 52 where the graft additionally comprises reinforcing fibers within said tubular member.
Claim 60
Dependent Claim 18 words
57 . The device of claim 52 where the graft additionally comprises radiopaque fibers within said tubular member.

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