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US5879366A Expired / Lapsed US ⏱️ 0.0 years remaining

Self-expanding defect closure device and method of making and using

Assignee: W.L. Gore and Associates Inc
•
Filing: 1996-12-20
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Granted: 1999-03-09
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Expires: 2016-12-20
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Abstract

Abstract The present invention relates to a self-expanding device for sealing a defect in a wall, such as a septal defect. The device of the present invention has a fluoropolymer membrane that is supported by an embedded wire structure having elastic properties which is capable of being compressed and inserted in the defect by a catheter and thereafter returning to its memory induced configuration. The device of the present invention can be employed in a variety of applications where a small hole needs to be sealed.

Inventors

  • 👤 Edward E. Shaw
  • 👤 Nitin V. Salunke
  • 👤 Gregory T. Mace

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-22 20:52
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/0057; A61B17/12; A61B17/122; A61B17/1227; A61B2017/00526; A61B2017/00575; A61B2017/00592; A61B2017/00597; A61B2017/00606; A61B2017/00623; A61B2017/00831; A61B2017/00867

Claims Analysis

Total Claims: 81
Claim 1
Independent Claim 124 words
A self expanding closure device, comprising: a) a thin membrane formed from at least one layer of material positionable to have first and second surfaces facing one another and adapted to close a wall defect; b) an elastic support attached to said membrane and forming first and second closure portions for said first and second facing surfaces; and said elastic support having a first configuration with a longitudinal axis and a diameter of d 1 which is compressible into a second, catheter insertable configuration of a diameter d 2 , where d 2 is less than d 1 , d 1 :d 2 is between about 5:1 and about 50:1, and said first configuration maintains said closure surfaces in close proximity to the defect.
Claim 2
Dependent Claim 124 words
A self expanding closure device, comprising: a) a thin membrane formed from at least one layer of material positionable to have first and second surfaces facing one another and adapted to close a wall defect; b) an elastic support attached to said membrane and forming first and second closure portions for said first and second facing surfaces; and said elastic support having a first configuration with a longitudinal axis and a diameter of d 1 which is compressible into a second, catheter insertable configuration of a diameter d 2 , where d 2 is less than d 1 , d 1 :d 2 is between about 5:1 and about 50:1, and said first configuration maintains said closure surfaces in close proximity to the defect.
Claim 3
Dependent Claim 19 words
The self-expanding closure device of claim 1, wherein said membrane includes at least two plies of cross-laminated biocompatible material.
Claim 4
Dependent Claim 15 words
The self expanding closure device according to claim 2, wherein said membrane is a fluoropolymer.
Claim 5
Dependent Claim 14 words
The self expanding closure device according to claim 3, wherein said fluoropolymer is polytetrafluoroethylene.
Claim 6
Dependent Claim 16 words
The self expanding closure device according to claim 3, wherein said fluoropolymer is porous, expanded polytetrafluoroethylene.
Claim 7
Dependent Claim 13 words
The self-expanding closure device of claim 2, wherein the membrane contains 4-8 plies.
Claim 8
Dependent Claim 16 words
The self expanding closure device according to claim 1, wherein said elastic support is a wire.
Claim 9
Dependent Claim 15 words
The self expanding closure device according to claim 7, wherein said wire is helically shaped.
Claim 10
Dependent Claim 24 words
The self expanding closure device according to claim 8, wherein said helically shaped wire contains at least two complete revolutions about said longitudinal axis.
Claim 11
Dependent Claim 31 words
The self expanding closure device according to claim 7, wherein said wire comprises two discrete substantially planer patterns, each of said patterns defining one of said first or second closure portions.
Claim 12
Dependent Claim 48 words
The self expanding closure device according to claim 10, wherein each of said patterns is star shaped, where arms of the star radially support said membrane and each of said arms includes first and second legs connected at their distal ends to respective ends of an arcuate connector.
Claim 13
Dependent Claim 21 words
The self expanding closure device according to claim 11, wherein said arcuate connector extends over an angle of less than 360°.
Claim 14
Dependent Claim 14 words
The self expanding closure device according to claim 7, wherein said wire is nitinol.
Claim 15
Dependent Claim 16 words
The self expanding closure device according to claim 7, wherein said wire has shape induced memory.
Claim 16
Dependent Claim 23 words
The self expanding closure device according to claim 1, wherein the ratio of d 1 :d 2 is about 10:1 to about 50:1.
Claim 17
Independent Claim 75 words
A method of assembling a self-expanding defect closure device, comprising: a) providing a first membrane portion; b) locating an elastic wire on an upper surface of said first membrane portion; c) locating a second membrane portion on an exposed surface of said wire of step b) and in contact with said upper surface of said first membrane portion; and d) affixing said first and second membrane portions to one another to attach said wire therein.
Claim 18
Independent Claim 75 words
A method of assembling a self-expanding defect closure device, comprising: a) providing a first membrane portion; b) locating an elastic wire on an upper surface of said first membrane portion; c) locating a second membrane portion on an exposed surface of said wire of step b) and in contact with said upper surface of said first membrane portion; and d) affixing said first and second membrane portions to one another to attach said wire therein.
Claim 19
Dependent Claim 27 words
The method according to claim 16, wherein said first and second membrane portions are formed from several plies of material that are cross laminated to one another.
Claim 20
Dependent Claim 11 words
The method according to claim 16, wherein said wire is nitinol.
Claim 21
Dependent Claim 14 words
The method according to claim 16, wherein said wire has a memory induced shape.
Claim 22
Dependent Claim 13 words
The method according to claim 19, wherein configuration is star shaped or helical.
Claim 23
Dependent Claim 16 words
The method according to claim 16, wherein said first and second membrane portions are a fluoropolymer.
Claim 24
Dependent Claim 11 words
The method according to claim 21, wherein said fluoropolymer is polytetrafluoroethylene.
Claim 25
Dependent Claim 12 words
The method according to claim 21, wherein said fluoropolymer is expanded polytetrafluoroethylene.
Claim 26
Dependent Claim 15 words
A self expanding defect closure device made in accordance with the method of claim 16.
Claim 27
Dependent Claim 29 words
The self expanding defect closure device according to claim 24, wherein said first and second membranes are formed from several plies of material that are cross-laminated to one another.
Claim 28
Dependent Claim 15 words
The self expanding defect closure device according to claim 24, wherein said wire is nitinol.
Claim 29
Dependent Claim 18 words
The self expanding defect closure device according to claim 24, wherein said wire has a memory induced configuration.
Claim 30
Dependent Claim 16 words
The self expanding defect closure device according to claim 27, wherein the configuration is star shaped.
Claim 31
Dependent Claim 19 words
The self expanding defect closure device according to claim 24, wherein said first and second membranes are a fluoropolymer.
Claim 32
Dependent Claim 15 words
The self expanding defect closure device according to claim 29, wherein said fluoropolymer is polytetrafluoroethylene.
Claim 33
Dependent Claim 15 words
The self expanding closure device according to claim 29, wherein said fluoropolymer is expanded polytetrafluoroethylene.
Claim 34
Dependent Claim 48 words
A method of closing a defect in a living animal, comprising, a) providing a 9F or smaller catheter; b) compressing and inserting the device of claim 1 into said catheter; c) deploying said compressed device in a defect; and d) inserting and releasing said device in said defect.
Claim 35
Dependent Claim 48 words
A method of closing a defect in a living animal, comprising, a) providing a 5F or smaller catheter; b) compressing and inserting the device of claim 1 into said catheter; c) deploying said compressed device in a defect; and d) inserting and releasing said device in said defect.
Claim 36
Dependent Claim 48 words
A method of closing a defect in a living animal, comprising, a) providing thoracoscopic delivery system; b) compressing and inserting the device of claim 1 into said thoracoscopic delivery system; c) deploying said compressed device in a defect; and d) inserting and releasing said device in said defect.
Claim 37
Dependent Claim 54 words
A method of closing a defect in a container wall, comprising, a) providing a delivery tube; b) compressing and inserting the device of claim 1 into said tube; c) deploying said compressed device in a defect of a container wall; and d) inserting and releasing said device in said defect in said container wall.
Claim 38
Dependent Claim 54 words
A method of closing a defect in a filter medium, comprising, a) providing a delivery tube; b) compressing and inserting the device of claim 1 into said tube; c) deploying said compressed device in a defect of a filter medium; and d) inserting and releasing said device in said defect in said filter medium.
Claim 39
Independent Claim 60 words
A method of assembling a self-expanding defect closure device, comprising: a) providing a membrane; b) locating a heat resistant tube on said membrane; c) folding and laminating said membrane about said heat resistant tube; d) inserting an elastic wire into said heat resistant tube; and e) removing said heat resistant tube and heating said membrane to embed said elastic wire.
Claim 40
Independent Claim 60 words
A method of assembling a self-expanding defect closure device, comprising: a) providing a membrane; b) locating a heat resistant tube on said membrane; c) folding and laminating said membrane about said heat resistant tube; d) inserting an elastic wire into said heat resistant tube; and e) removing said heat resistant tube and heating said membrane to embed said elastic wire.
Claim 41
Dependent Claim 22 words
The method according to claim 37, wherein said membrane is formed from several plies of material that are cross-laminated to one another.
Claim 42
Dependent Claim 11 words
The method according to claim 37, wherein said wire is nitinol.
Claim 43
Dependent Claim 14 words
The method according to claim 37, wherein said wire has a memory induced configuration.
Claim 44
Dependent Claim 15 words
The method according to claim 37, wherein said wire has a memory induced helical configuration.
Claim 45
Dependent Claim 12 words
The method according to claim 37, wherein said membrane is a fluoropolymer.
Claim 46
Dependent Claim 11 words
The method according to claim 42, wherein said fluoropolymer is polytetrafluoroethylene.
Claim 47
Dependent Claim 12 words
The method according to claim 42, wherein said fluoropolymer is expanded polytetrafluoroethylene.
Claim 48
Dependent Claim 116 words
A self expanding closure device, comprising: a) a thin membrane formed from at least two plies of cross-laminated biocompatible materials positionable to have first and second surfaces facing one another and adapted to close a wall defect; b) an elastic support attached to said membrane and forming first and second closure portions for said first and second facing surfaces; and said elastic support having a first configuration with a longitudinal axis and a diameter of d1 which is compressible into a second, catheter insertable configuration of a diameter d2, where d2 is less than d1, d1:d2 is between about 5:1 and about 50:1, and first configuration maintains said closure surfaces in close proximity to the defect.
Claim 49
Dependent Claim 116 words
A self expanding closure device, comprising: a) a thin membrane formed from at least two plies of cross-laminated biocompatible materials positionable to have first and second surfaces facing one another and adapted to close a wall defect; b) an elastic support attached to said membrane and forming first and second closure portions for said first and second facing surfaces; and said elastic support having a first configuration with a longitudinal axis and a diameter of d1 which is compressible into a second, catheter insertable configuration of a diameter d2, where d2 is less than d1, d1:d2 is between about 5:1 and about 50:1, and first configuration maintains said closure surfaces in close proximity to the defect.
Claim 50
Dependent Claim 16 words
The self expanding closure device according to claim 45, wherein said elastic support is a wire.
Claim 51
Dependent Claim 15 words
The self expanding closure device according to claim 46, wherein said wire is helically shaped.
Claim 52
Dependent Claim 24 words
The self expanding closure device according to claim 47, wherein said helically shaped wire contains at least two complete revolutions about said longitudinal axis.
Claim 53
Dependent Claim 31 words
The self expanding closure device according to claim 46, wherein said wire comprises two discrete substantially planer patterns, each of said patterns defining one of said first or second closure portions.
Claim 54
Dependent Claim 48 words
The self expanding closure device according to claim 49, wherein each of said patterns is star shaped, where arms of the star radially support said membrane and each of said arms includes first and second legs connected at their distal ends to respective ends of an arcuate connector.
Claim 55
Dependent Claim 22 words
The self expanding closure device according to claim 50, wherein said arcuate connector extends over an angle of less than 360 degrees.
Claim 56
Dependent Claim 14 words
The self expanding closure device according to claim 46, wherein said wire is nitinol.
Claim 57
Dependent Claim 16 words
The self expanding closure device according to claim 46, wherein said wire has shape induced memory.
Claim 58
Dependent Claim 15 words
The self expanding closure device according to claim 45, wherein said membrane is a fluoropolymer.
Claim 59
Dependent Claim 14 words
The self expanding closure device according to claim 54, wherein said fluoropolymer is polytetrafluoroethylene.
Claim 60
Dependent Claim 16 words
The self expanding closure device according to claim 54, wherein said fluoropolymer is porous, expanded polytetrafluoroethylene.
Claim 61
Dependent Claim 14 words
The self expanding closure device of claim 45, wherein the membrane contains 4-8 plies.
Claim 62
Dependent Claim 23 words
The self expanding closure device according to claim 45, wherein the ratio of d 1 :d 2 is about 10:1 to about 50:1.
Claim 63
Dependent Claim 173 words
A self expanding closure device, comprising: a) a thin membrane formed from at least one layer of material positionable to have first and second surfaces facing one another and adapted to close a wall defect; b) an elastic wire attached to said membrane and forming first and second closure portions for said first and second facing surfaces; c) said elastic wire comprises two discrete substantially planer star shaped patterns, each of said star shaped patterns defining one of said first or second closure portions, where arms of the star radially support said membrane and each of said arms includes first and second legs connected at their distal ends to respective ends of an arcuate connector; and d) said elastic wire having a first configuration with a longitudinal axis and a diameter of d1 which is compressible into a second, catheter insertable configuration of a diameter d2, where d2 is less than d1, d1:d2 is between about 5:1 and about 50:1, and first configuration maintains said closure surfaces in close proximity to the defect.
Claim 64
Dependent Claim 173 words
A self expanding closure device, comprising: a) a thin membrane formed from at least one layer of material positionable to have first and second surfaces facing one another and adapted to close a wall defect; b) an elastic wire attached to said membrane and forming first and second closure portions for said first and second facing surfaces; c) said elastic wire comprises two discrete substantially planer star shaped patterns, each of said star shaped patterns defining one of said first or second closure portions, where arms of the star radially support said membrane and each of said arms includes first and second legs connected at their distal ends to respective ends of an arcuate connector; and d) said elastic wire having a first configuration with a longitudinal axis and a diameter of d1 which is compressible into a second, catheter insertable configuration of a diameter d2, where d2 is less than d1, d1:d2 is between about 5:1 and about 50:1, and first configuration maintains said closure surfaces in close proximity to the defect.
Claim 65
Dependent Claim 22 words
The self expanding closure device according to claim 59, wherein said arcuate connector extends over an angle of less than 360 degrees.
Claim 66
Dependent Claim 14 words
The self expanding closure device according to claim 59, wherein said wire is nitinol.
Claim 67
Dependent Claim 16 words
The self expanding closure device according to claim 59, wherein said wire has shape induced memory.
Claim 68
Dependent Claim 15 words
The self expanding closure device according to claim 59, wherein said membrane is a fluoropolymer.
Claim 69
Dependent Claim 14 words
The self expanding closure device according to claim 63, wherein said fluoropolymer is polytetrafluoroethylene.
Claim 70
Dependent Claim 16 words
The self expanding closure device according to claim 63, wherein said fluoropolymer is porous, expanded polytetrafluoroethylene.
Claim 71
Dependent Claim 14 words
The self expanding closure device of claim 59, wherein the membrane contains 4-8 layers.
Claim 72
Dependent Claim 23 words
The self expanding closure device according to claim 72, wherein the ratio of d 1 :d 2 is about 10:1 to about 50:1.
Claim 73
Dependent Claim 67 words
A self expanding defect closure device, comprising: a) a first membrane portion having an upper surface; b) an elastic wire contacting the upper surface of the first membrane portion; c) a second membrane portion contacting the elastic wire and the upper surface of the first membrane portion; and d) a means for affixing said first and second membrane portions to one another to attach said wire therein.
Claim 74
Dependent Claim 67 words
A self expanding defect closure device, comprising: a) a first membrane portion having an upper surface; b) an elastic wire contacting the upper surface of the first membrane portion; c) a second membrane portion contacting the elastic wire and the upper surface of the first membrane portion; and d) a means for affixing said first and second membrane portions to one another to attach said wire therein.
Claim 75
Dependent Claim 29 words
The self expanding defect closure device according to claim 68, wherein said first and second membranes are formed from at least two plies of material that are cross-laminated together.
Claim 76
Dependent Claim 15 words
The self expanding defect closure device according to claim 68, wherein said wire is nitinol.
Claim 77
Dependent Claim 18 words
The self expanding defect closure device according to claim 68, wherein said wire has a memory induced configuration.
Claim 78
Dependent Claim 16 words
The self expanding defect closure device according to claim 71, wherein the configuration is star shaped.
Claim 79
Dependent Claim 19 words
The self expanding defect closure device according to claim 68, wherein said first and second membranes are a fluoropolymer.
Claim 80
Dependent Claim 15 words
The self expanding defect closure device according to claim 73, wherein said fluoropolymer is polytetrafluoroethylene.
Claim 81
Dependent Claim 15 words
The self expanding closure device according to claim 73, wherein said fluoropolymer is expanded polytetrafluoroethylene.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2002-03-08 2002-09-07 2003-03-09 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2006-03-08 2006-09-07 2007-03-09 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2010-03-08 2010-09-07 2011-03-09 $7700.00 Window Closed / Lapsed

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