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US7318833B2 Expired / Lapsed US ⏱️ 0.0 years remaining

PFO closure device with flexible thrombogenic joint and improved dislodgement resistance

Assignee: W.L. Gore and Associates Inc
•
Filing: 2003-09-12
•
Granted: 2008-01-15
•
Expires: 2023-09-12
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Abstract

Abstract The present invention provides devices for closing septal defects, such as a patent foramen ovale (PFO). The closure devices include a proximal anchor member, a distal anchor member, and at least one flexible center joint connecting the two anchor members. According to some embodiments, the proximal and/or distal anchor members may include a generally cylindrical member split along the central portion of its length to form an elongate oval. The proximal and/or distal anchor members may further include a tissue scaffold. At least some of the closure devices according to the present invention are repositionable and retrievable.

Inventors

  • 👤 Andrzej J. CHANDUSZKO

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-26 12:02
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/0057; A61B2017/00575; A61B2017/00592; A61B2017/00606

Claims Analysis

Total Claims: 45
Claim 1
Independent Claim 155 words
A device for closing a defect in septal tissue, comprising: a first side adapted to be disposed on one side of the septal tissue and a second side adapted to be disposed on the opposite side of the septal tissue, said first and second sides connected by at least one flexible center joint, wherein each of said first and second sides includes an anchor member, and wherein the anchor member of at least one of said first and second sides comprises a generally cylindrical member, having a longitudinal axis, a split along the central portion of a length of said cylindrical member forming an elongate oval having a surface area adapted to substantially abut the septal tissue, wherein the flexible center joint is attached to at least one of the generally cylindrical members such that the longitudinal axis of the generally cylindrical members extends generally transverse to the flexible center joint in the deployed configuration.
Claim 2
Independent Claim 155 words
A device for closing a defect in septal tissue, comprising: a first side adapted to be disposed on one side of the septal tissue and a second side adapted to be disposed on the opposite side of the septal tissue, said first and second sides connected by at least one flexible center joint, wherein each of said first and second sides includes an anchor member, and wherein the anchor member of at least one of said first and second sides comprises a generally cylindrical member, having a longitudinal axis, a split along the central portion of a length of said cylindrical member forming an elongate oval having a surface area adapted to substantially abut the septal tissue, wherein the flexible center joint is attached to at least one of the generally cylindrical members such that the longitudinal axis of the generally cylindrical members extends generally transverse to the flexible center joint in the deployed configuration.
Claim 3
Dependent Claim 31 words
The device of claim 1 , wherein said at least one center joint extends through the defect in the septal tissue when said device is deployed at its intended delivery location.
Claim 4
Dependent Claim 25 words
The device of claim 2 , wherein said first and second sides cooperate to provide a compressive force to the septal tissue surrounding the defect.
Claim 5
Dependent Claim 32 words
The device of claim 1 , wherein each of said first and second sides comprises a generally cylindrical member split along the central portion of its length to form an elongate oval.
Claim 6
Dependent Claim 15 words
The device of claim 4 , wherein said first and second anchor members are three-dimensional.
Claim 7
Dependent Claim 34 words
The device of claim 1 , wherein said anchor members include a material selected from the group consisting of metals, polymers, shape memory materials, bioresorbable materials, drug-exuding materials, and combinations of the foregoing materials.
Claim 8
Dependent Claim 18 words
The device of claim 1 , wherein said at least one center joint includes a stretchable elastomeric material.
Claim 9
Dependent Claim 18 words
The device of claim 7 , wherein said at least one center joint includes a shape memory material.
Claim 10
Dependent Claim 15 words
The device of claim 8 , wherein said at least one center joint includes nitinol.
Claim 11
Dependent Claim 17 words
The device of claim 9 , wherein said at least one center joint comprises a nitinol film.
Claim 12
Dependent Claim 21 words
The device of claim 10 , wherein said nitinol film includes openings selected from the group consisting of slits and holes.
Claim 13
Dependent Claim 26 words
The device of claim 7 , wherein said at least one center joint includes a material that promotes closure of the defect in the septal tissue.
Claim 14
Dependent Claim 34 words
The device of claim 12 , wherein said at least one center joint includes a material selected from the group consisting of thrombogenic materials, inflammatory materials, drug-exuding materials, and combinations of the foregoing materials.
Claim 15
Dependent Claim 15 words
The device of claim 7 , wherein said at least one center joint is porous.
Claim 16
Dependent Claim 21 words
The device of claim 1 , wherein at least one of said first and second anchor members includes a tissue scaffold.
Claim 17
Dependent Claim 46 words
The device of claim 15 , wherein said tissue scaffold includes a material selected from the group consisting of polyester fabrics, Teflon-based materials, ePTFE, polyurethanes, metallic materials, polyvinyl alcohol (PVA), extracellular matrix (ECM), synthetic bioabsorbable polymeric scaffolds, collagen, drug-exuding materials, and combinations of the foregoing materials.
Claim 18
Dependent Claim 19 words
The device of claim 1 , wherein each of said first and second anchor members includes a tissue scaffold.
Claim 19
Dependent Claim 19 words
The device of claim 17 , wherein said at least one center joint is connected to said tissue scaffolds.
Claim 20
Dependent Claim 11 words
The device of claim 1 , wherein said device is retrievable.
Claim 21
Dependent Claim 32 words
The device of claim 1 , wherein the center joint is attached to at least one of the generally cylindrical members at a portion of the split in the generally cylindrical member.
Claim 22
Dependent Claim 30 words
The device of claim 1 , wherein the center joint is attached to at least one of the generally cylindrical members proximate to a periphery of the generally cylindrical member.
Claim 23
Dependent Claim 35 words
The device of claim 1 , wherein the center joint is attached to at least one of the generally cylindrical members at a location between a periphery and the split of the generally cylindrical member.
Claim 24
Independent Claim 172 words
A device for closing a defect in septal tissue, comprising: a first side adapted to be disposed on one side of the septal tissue and a second side adapted to be disposed on the opposite side of the septal tissue, said first and second sides connected by a at least one flexible center joint, wherein each of said first and second sides includes an anchor member comprising a generally cylindrical member, having a longitudinal axis, a split along the central portion of a length of said cylindrical member forming an elongate oval having a surface area adapted to substantially abut the septal tissue, and wherein said first and second sides cooperate to provide a compressive force to the septal tissue surrounding the defect when said device is deployed at an intended delivery location and wherein the flexible center joint is attached to at least one of the generally cylindrical members such that the longitudinal axis of the respective cylindrical member extends generally transverse to the flexible center joint in the deployed configuration.
Claim 25
Independent Claim 172 words
A device for closing a defect in septal tissue, comprising: a first side adapted to be disposed on one side of the septal tissue and a second side adapted to be disposed on the opposite side of the septal tissue, said first and second sides connected by a at least one flexible center joint, wherein each of said first and second sides includes an anchor member comprising a generally cylindrical member, having a longitudinal axis, a split along the central portion of a length of said cylindrical member forming an elongate oval having a surface area adapted to substantially abut the septal tissue, and wherein said first and second sides cooperate to provide a compressive force to the septal tissue surrounding the defect when said device is deployed at an intended delivery location and wherein the flexible center joint is attached to at least one of the generally cylindrical members such that the longitudinal axis of the respective cylindrical member extends generally transverse to the flexible center joint in the deployed configuration.
Claim 26
Dependent Claim 34 words
The device of claim 23 , wherein said anchor members include a material selected from the group consisting of metals, polymers, shape memory materials, bioresorbable materials, drug-exuding materials, and combinations of the foregoing materials.
Claim 27
Dependent Claim 16 words
The device of claim 24 , wherein each of said elongate oval anchor members is three-dimensional.
Claim 28
Dependent Claim 24 words
The device of claim 25 , wherein each of said elongate oval anchor members is configured to minimize the septal profile of said device.
Claim 29
Dependent Claim 34 words
The device of claim 26 , wherein the arcs of said elongate oval anchor members are positioned at an angle θ from the plane of said device orthogonal to the axis of the centerjoint.
Claim 30
Dependent Claim 18 words
The device of claim 27 , wherein each of said elongate oval anchor members is concave in shape.
Claim 31
Dependent Claim 21 words
The device of claim 27 , wherein said angle θ is greater than 0 degrees and less than about 45 degrees.
Claim 32
Dependent Claim 19 words
The device of claim 23 , wherein each of said first and second anchor members includes a tissue scaffold.
Claim 33
Dependent Claim 46 words
The device of claim 30 , wherein said tissue scaffold includes a material selected from the group consisting of polyester fabrics, Teflon-based materials, ePTFE, polyurethanes, metallic materials, polyvinyl alcohol (PVA), extracellular matrix (ECM), synthetic bioabsorbable polymeric scaffolds, collagen, drug-exuding materials, and combinations of the foregoing materials.
Claim 34
Dependent Claim 18 words
The device of claim 23 , wherein said at least one center joint includes a stretchable elastomeric material.
Claim 35
Dependent Claim 18 words
The device of claim 32 , wherein said at least one center joint includes a shape memory material.
Claim 36
Dependent Claim 15 words
The device of claim 33 , wherein said at least one center joint includes nitinol.
Claim 37
Dependent Claim 26 words
The device of claim 32 , wherein said at least one center joint includes a material that promotes closure of the defect in the septal tissue.
Claim 38
Dependent Claim 34 words
The device of claim 35 , wherein said at least one center joint includes a material selected from the group consisting of thrombogenic materials, inflammatory materials, drug-exuding materials, and combinations of the foregoing materials.
Claim 39
Dependent Claim 20 words
The device of claim 23 , further comprising a retrieval mechanism for retrieving said device from its intended delivery location.
Claim 40
Dependent Claim 25 words
The device of claim 37 , wherein said retrieval mechanism reduces the profile of said device such that said device may drawn into a catheter.
Claim 41
Dependent Claim 32 words
The device of claim 38 , wherein said retrieval mechanism reduces the distance between said first and second anchor members and aligns said first and second anchor members in a longitudinal orientation.
Claim 42
Dependent Claim 41 words
The device of claim 38 , wherein said retrieval mechanism comprises a string extending from one end of said first anchor member to and through said second anchor member, and a ball constrained on said string within said second anchor member.
Claim 43
Dependent Claim 11 words
The device of claim 40 , wherein said string is flexible.
Claim 44
Independent Claim 166 words
A device for closing a defect in septal tissue, comprising: a first side adapted to be disposed on one side of the septal tissue and a second side adapted to be disposed on the opposite side of the septal tissue, said first and second sides connected by at least one flexible center joint, wherein each of said first and second sides includes an anchor member, wherein a first anchor member of at least one of said first and second sides comprises a generally cylindrical member, having a longitudinal axis, a split along the central portion of a length of said cylindrical member forming an elongate oval having a surface area adapted to substantially abut the septal tissue; and wherein the first anchor member includes a tissue scaffold attached to the generally cylindrical member, wherein the flexible center joint is attached to the tissue scaffold such that the longitudinal axis of the generally cylindrical member extends generally transverse to the flexible center joint in the deployed configuration.
Claim 45
Independent Claim 166 words
A device for closing a defect in septal tissue, comprising: a first side adapted to be disposed on one side of the septal tissue and a second side adapted to be disposed on the opposite side of the septal tissue, said first and second sides connected by at least one flexible center joint, wherein each of said first and second sides includes an anchor member, wherein a first anchor member of at least one of said first and second sides comprises a generally cylindrical member, having a longitudinal axis, a split along the central portion of a length of said cylindrical member forming an elongate oval having a surface area adapted to substantially abut the septal tissue; and wherein the first anchor member includes a tissue scaffold attached to the generally cylindrical member, wherein the flexible center joint is attached to the tissue scaffold such that the longitudinal axis of the generally cylindrical member extends generally transverse to the flexible center joint in the deployed configuration.

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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) 2011-01-14 2011-07-16 2012-01-15 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2015-01-14 2015-07-16 2016-01-15 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2019-01-14 2019-07-16 2020-01-15 $7700.00 Window Closed / Lapsed

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