PFO closure device with flexible thrombogenic joint and improved dislodgement resistance

• US 7,967,840 B2
• Filed: 10/10/2007
• Issued: 06/28/2011
• Est. Priority Date: 12/19/2001
• Status: Expired due to Fees

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: NMT Medical Incorporated
• Inventors: Chanduszko, Andrzej J.
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T
• Assistant Examiner(s): RYCKMAN, MELISSA K
• Application Number:
  US11/870,150
• Publication Number:
  US 20080228218A1
• Time in Patent Office: 1,357 Days
• Field of Search: 606/213, 606/215, 606/216, 606/94, 600/37, 604/96.01, 604/101.5
• US Class Current: 606/215
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening

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.

Claims

1. 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 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 split along a central portion of a length of an outer circumferential wall of the generally cylindrical member to form an elongate oval.

2. 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.

3. The device of claim 2, wherein said first and second sides cooperate to provide a compressive force to the septal tissue surrounding the defect.

4. The device of claim 1, wherein each of said first and second sides comprises a generally cylindrical member split along a central portion of a length of an outer circumferential wall of the generally cylindrical member to form an elongate oval.

5. 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.

6. The device of claim 1, wherein said at least one center joint includes a stretchable elastomeric material.

7. The device of claim 1, wherein said at least one center joint includes a shape memory material.

8. The device of claim 7, wherein said at least one center joint comprises a nitinol film.

9. The device of claim 1, wherein said at least one center joint is porous.

10. The device of claim 1, wherein at least one of said first and second anchor members includes a tissue scaffold.

11. The device of claim 10, 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.

12. The device of claim 10, wherein each of said first and second anchor members includes a tissue scaffold.

13. The device of claim 12, wherein said at least one center joint is connected to said tissue scaffolds.

14. 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 center joint,

wherein each of said first and second sides includes an anchor member comprising a generally cylindrical member split along a central portion of a length of an outer circumferential wall of the generally cylindrical member to define a plurality of arcs that form an elongate oval therebetween, 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.

15. The device of claim 14, 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.

16. The device of claim 14, wherein the plurality of arcs of said elongate oval anchor members are positioned at an angle θ

from a plane of said device orthogonal to the axis of the center joint.

17. The device of claim 16, wherein each of said elongate oval anchor members is concave in shape.

18. The device of claim 16, wherein said angle θ

is greater than 0 degrees and less than about 45 degrees.

19. The device of claim 14, wherein said at least one center joint includes a stretchable elastomeric material.

20. The device of claim 14, wherein said at least one center joint includes a shape memory material.

21. The device of claim 14, wherein said at least one center joint includes a material that promotes closure of the defect in the septal tissue.

22. The device of claim 21, 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.

23. The device of claim 14, further comprising a retrieval mechanism for retrieving said device from its intended delivery location.

24. The device of claim 23, 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.

25. The device of claim 23, 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.