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US6080182A 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
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Filing: 1997-12-19
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Granted: 2000-06-27
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Expires: 2017-12-19
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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 2026-10-23 19:31
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: 48
Claim 1
Independent Claim 121 words
A closure device comprising the device having a compressed insertion configuration and an enlarged deployed configuration; an elastic support, the support having a length and being substantially elongated in the insertion configuration and bending to form an outer periphery of the closure device in the deployed configuration; a sheet attached along at least a portion of the length of the elastic support in the insertion configuration, the sheet forming a barrier within the outer periphery in the deployed configuration; wherein the elastic support in the deployed configuration has a diameter of d 1 and the elastic support in the insertion configuration has a diameter of d 2 , where the ratio of d 1 :d 2 is greater than about 5:1.
Claim 2
Dependent Claim 121 words
A closure device comprising the device having a compressed insertion configuration and an enlarged deployed configuration; an elastic support, the support having a length and being substantially elongated in the insertion configuration and bending to form an outer periphery of the closure device in the deployed configuration; a sheet attached along at least a portion of the length of the elastic support in the insertion configuration, the sheet forming a barrier within the outer periphery in the deployed configuration; wherein the elastic support in the deployed configuration has a diameter of d 1 and the elastic support in the insertion configuration has a diameter of d 2 , where the ratio of d 1 :d 2 is greater than about 5:1.
Claim 3
Dependent Claim 29 words
The closure device of claim 1 wherein the closure device is contained within a tube in the insertion configuration, the tube being no more than 8 F in diameter.
Claim 4
Dependent Claim 22 words
The closure device of claim 1 wherein the elastic support bends helically when enlarging from the insertion configuration to the deployed configuration.
Claim 5
Dependent Claim 30 words
The closure device of claim 1 wherein the elastic support comprises a wire and the sheet is folded over the wire where attached along the length of the elastic support.
Claim 6
Dependent Claim 11 words
The closure device of claim 1 wherein the sheet comprises polytetrafluoroethylene.
Claim 7
Dependent Claim 128 words
A closure device comprising the device having a compressed insertion configuration and an enlarged deployed configuration; an elastic support having a substantially elongated length in the insertion configuration and forming an outer periphery of the closure device in the deployed configuration; the outer periphery of the closure device having a linear length; a sheet attached along at least a portion of the length of the elastic support in the insertion configuration and forming a barrier within the outer periphery in the deployed configuration; the length of the elongated elastic support relative to the total linear length of the periphery being a ratio of greater than about 0.7; wherein the sheet is folded over the elastic support where the sheet is attached along the length of the elastic support.
Claim 8
Dependent Claim 128 words
A closure device comprising the device having a compressed insertion configuration and an enlarged deployed configuration; an elastic support having a substantially elongated length in the insertion configuration and forming an outer periphery of the closure device in the deployed configuration; the outer periphery of the closure device having a linear length; a sheet attached along at least a portion of the length of the elastic support in the insertion configuration and forming a barrier within the outer periphery in the deployed configuration; the length of the elongated elastic support relative to the total linear length of the periphery being a ratio of greater than about 0.7; wherein the sheet is folded over the elastic support where the sheet is attached along the length of the elastic support.
Claim 9
Dependent Claim 29 words
The closure device of claim 6 wherein the closure device is contained within a tube in the insertion configuration, the tube being no more than 8 F in diameter.
Claim 10
Dependent Claim 22 words
The closure device of claim 6 wherein the elastic support bends helically when enlarging from the insertion configuration to the deployed configuration.
Claim 11
Dependent Claim 48 words
The closure device of claim 6 wherein the elastic support in the deployed configuration has a diameter of d 1 and the elastic support in the insertion configuration has a diameter of d 2 , where the ratio of d 1 :d 2 is greater than about 5:1.
Claim 12
Dependent Claim 21 words
The closure device of claim 6 wherein the elastic support comprises a wire and the sheet is folded over the wire.
Claim 13
Dependent Claim 11 words
The closure device of claim 6 wherein the sheet comprises polytetrafluoroethylene.
Claim 14
Dependent Claim 105 words
A closure device comprising the device having a compressed insertion configuration and an enlarged deployed configuration; an elastic support, the support having a length and being substantially elongated in the insertion configuration and bending to form an outer periphery of the closure in the deployed configuration; the outer periphery being formed progressively about a central axis in an angular progression as the elastic support bends from the insertion configuration to the deployed configuration; and a sheet attached along at least a portion of the length of the elastic support in the insertion configuration and forming a barrier within the outer periphery in the deployed configuration.
Claim 15
Dependent Claim 105 words
A closure device comprising the device having a compressed insertion configuration and an enlarged deployed configuration; an elastic support, the support having a length and being substantially elongated in the insertion configuration and bending to form an outer periphery of the closure in the deployed configuration; the outer periphery being formed progressively about a central axis in an angular progression as the elastic support bends from the insertion configuration to the deployed configuration; and a sheet attached along at least a portion of the length of the elastic support in the insertion configuration and forming a barrier within the outer periphery in the deployed configuration.
Claim 16
Dependent Claim 83 words
A closure device having a compressed insertion configuration and an enlarged deployed configuration comprising at least one sealing member having a first edge and a second edge; and means cooperating with the sealing member for enlarging during deployment the first edge into a peripheral edge; and means cooperating with the sealing member for converging during deployment the second edge into a central edge; wherein the sealing member forms a barrier in the deployed configuration extending between the central edge and the peripheral edge.
Claim 17
Dependent Claim 83 words
A closure device having a compressed insertion configuration and an enlarged deployed configuration comprising at least one sealing member having a first edge and a second edge; and means cooperating with the sealing member for enlarging during deployment the first edge into a peripheral edge; and means cooperating with the sealing member for converging during deployment the second edge into a central edge; wherein the sealing member forms a barrier in the deployed configuration extending between the central edge and the peripheral edge.
Claim 18
Dependent Claim 18 words
The device of claim 13 that further includes means for securing the central edge in a converged position.
Claim 19
Dependent Claim 30 words
The device of claim 14 that further includes at least two sealing members; and means for securing a first sealing member to a second sealing member in the deployed configuration.
Claim 20
Dependent Claim 89 words
A closure device comprising: a) a membrane formed from at least one layer of material adapted to close a wall defect; b) an elastic support attached to said membrane and adapted to extend the membrane into a barrier for closing the wall defect; wherein the elastic support has a first deployed configuration with a longitudinal axis and a diameter of d 1 which is compressible into a second insertion configuration of a diameter d 2 , where the ratio of d 1 :d 2 is greater than about 5:1.
Claim 21
Dependent Claim 89 words
A closure device comprising: a) a membrane formed from at least one layer of material adapted to close a wall defect; b) an elastic support attached to said membrane and adapted to extend the membrane into a barrier for closing the wall defect; wherein the elastic support has a first deployed configuration with a longitudinal axis and a diameter of d 1 which is compressible into a second insertion configuration of a diameter d 2 , where the ratio of d 1 :d 2 is greater than about 5:1.
Claim 22
Dependent Claim 18 words
The closure device of claim 15 wherein said membrane includes at least two plies of cross-laminated biocompatible material.
Claim 23
Dependent Claim 14 words
The closure device according to claim 16 wherein said elastic support is a wire.
Claim 24
Dependent Claim 13 words
The closure device according to claim 18 wherein said wire is helically shaped.
Claim 25
Dependent Claim 22 words
The closure device according to claim 19 wherein said helically shaped wire contains at least two complete revolutions about said longitudinal axis.
Claim 26
Dependent Claim 12 words
The closure device according to claim 18 wherein said wire is nitinol.
Claim 27
Dependent Claim 14 words
The closure device according to claim 18 wherein said wire has shape induced memory.
Claim 28
Dependent Claim 23 words
The closure device according to claim 16 wherein the elastic support forms two barriers adapted to seal two sides of a wall defect.
Claim 29
Dependent Claim 24 words
The closure device according to claim 23 wherein each of said barriers is star shaped, where arms of the star radially support said membrane.
Claim 30
Dependent Claim 41 words
The closure device according to claim 24 wherein each of said arms includes first and second legs connected at their distal ends to respective ends of an arcuate connector; and the arcuate connector extends over an angle of less than 360°.
Claim 31
Dependent Claim 13 words
The closure device according to claim 16 wherein said membrane is a fluoropolymer.
Claim 32
Dependent Claim 16 words
The closure device according to claim 26 wherein said fluoropolymer is a copolymer containing tetrafluoroethylene polymer.
Claim 33
Dependent Claim 13 words
The closure device according to claim 25 wherein said fluoropolymer is expanded polytetrafluoroethylene.
Claim 34
Dependent Claim 12 words
The method according to claim 28 wherein said fluoropolymer is expanded polytetrafluoroethylene.
Claim 35
Dependent Claim 14 words
The closure device of claim 15 wherein the membrane contains 4 to 8 plies.
Claim 36
Independent Claim 52 words
A method of assembling a defect closure device comprising: a) providing a first membrane; b) locating a tube on said membrane; c) folding and laminating said membrane about said tube; d) inserting an elastic wire into said tube; and e) removing said tube and heating said membrane to embed said elastic wire.
Claim 37
Independent Claim 52 words
A method of assembling a defect closure device comprising: a) providing a first membrane; b) locating a tube on said membrane; c) folding and laminating said membrane about said tube; d) inserting an elastic wire into said tube; and e) removing said tube and heating said membrane to embed said elastic wire.
Claim 38
Dependent Claim 22 words
The method according to claim 31 that further comprises forming membrane from several plies of material that are cross-laminated to one another.
Claim 39
Dependent Claim 13 words
The method according to claim 31 that further comprises providing nitinol as wire.
Claim 40
Dependent Claim 21 words
The method according to claim 31 that further comprises providing as the wire a material that has a memory induced configuration.
Claim 41
Dependent Claim 18 words
The method according to claim 34 that further comprises providing a wire with a memory induced helical configuration.
Claim 42
Dependent Claim 16 words
The method according to claim 31 that further comprises providing a fluoropolymer material as the membrane.
Claim 43
Dependent Claim 14 words
The method according to claim 36 wherein said fluoropolymer material is a tetrafluoroethylene polymer.
Claim 44
Dependent Claim 149 words
A closure device comprising the device having a compressed insertion configuration and an enlarged deployed configuration; an elastic support having a substantially elongated length in the insertion configuration and forming an outer periphery of the closure device in the deployed configuration; the outer periphery of the closure device having a linear length; a sheet attached along at least a portion of the length of the elastic support in the insertion configuration and forming a barrier within the outer periphery in the deployed configuration; the length of the elongated elastic support relative to the total linear length of the periphery being a ratio of greater than about 0.7; wherein the elastic support in the deployed configuration has a diameter of d 1 and the elastic support in the insertion configuration has a diameter of d 2 , where the ratio of d 1 :d 2 is greater than about 5:1.
Claim 45
Dependent Claim 149 words
A closure device comprising the device having a compressed insertion configuration and an enlarged deployed configuration; an elastic support having a substantially elongated length in the insertion configuration and forming an outer periphery of the closure device in the deployed configuration; the outer periphery of the closure device having a linear length; a sheet attached along at least a portion of the length of the elastic support in the insertion configuration and forming a barrier within the outer periphery in the deployed configuration; the length of the elongated elastic support relative to the total linear length of the periphery being a ratio of greater than about 0.7; wherein the elastic support in the deployed configuration has a diameter of d 1 and the elastic support in the insertion configuration has a diameter of d 2 , where the ratio of d 1 :d 2 is greater than about 5:1.
Claim 46
Dependent Claim 29 words
The closure device of claim 38 wherein the closure device is contained within a tube in the insertion configuration, the tube being no more than 8 F in diameter.
Claim 47
Dependent Claim 22 words
The closure device of claim 38 wherein the elastic support bends helically when enlarging from the insertion configuration to the deployed configuration.
Claim 48
Dependent Claim 30 words
The closure device of claim 38 wherein the elastic support comprises a wire and the sheet is folded over the wire where attached along the length of the elastic support.

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USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2003-06-27 2003-12-27 2004-06-27 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2007-06-27 2007-12-27 2008-06-27 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2011-06-27 2011-12-27 2012-06-27 $7700.00 Window Closed / Lapsed

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