Patent foramen ovale (PFO) closure device with radial and circumferential support

• US 7,431,729 B2
• Filed: 06/05/2003
• Issued: 10/07/2008
• Est. Priority Date: 06/05/2002
• Status: Expired due to Term

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: NMT Medical Incorporated
• Inventors: Chanduszko, Andrzej J.
• Primary Examiner(s): Dvorak; Linda
• Assistant Examiner(s): KASZTEJNA, MATTHEW JOHN
• Application Number:
  US10/455,572
• Publication Number:
  US 20040073242A1
• Time in Patent Office: 1,951 Days
• Field of Search: 600/213, 600/215, 600/139, 600/151, 600/232, 600/220, 600/32, 623/32, 604/285, 604/286
• US Class Current: 606/213
• 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 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• 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
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014

Abstract

The present invention provides a device for occluding an anatomical aperture, such as a septal defect or patent foramen ovale (PFO). The occluder includes two sides connected by an intermediate joint. Each of the sides includes at least one elongate element, which is arranged to form non-overlapping loops. Each loop has at least one radially-extending segment that is adjacent to a radially-extending segment of another loop. In at least some embodiments, at least one pair of adjacent radially-extending segments is connected. The loops of the device may be of various shapes, sizes, and configurations, and, in at least some embodiments, the loops have rounded peripheries. In some embodiments, at least one of the sides includes a tissue scaffold. When the occluder is deployed in vivo, the two sides are disposed on opposite sides of the septal tissue surrounding the aperture, thereby exerting a compressive force on the septal tissue that is distributed along both the outer periphery of the occluder and the radially-extending segments.

Claims

1. A device for occluding a defect in septal tissue, comprising:

a first side adapted to be disposed on one side of septal tissue with a defect and a second side adapted to be disposed on an opposite side of the septal tissue with a defect,

an elongate center joint disposed between the first and second sides,

said first and second sides adapted to occlude the defect upon deployment at the delivery location,

said first and second sides each comprising a plurality of non-overlapping wires,

wherein said wires form loops that extend from a center axis, the loops having inner ends proximate to the center axis and outer ends distal from the center axis, and adjacent segments of said loops are connected to each other along a generally radially extending length of the pair of adjacent segments including a point between the inner ends and the outer ends of the respective loops.

2. The device of claim 1, wherein said device is adapted to center around an asymmetrically-located defect.

3. The device of claim 1, wherein said adjacent segments are welded.

4. The device of claim 1, wherein said device includes a material selected from the group consisting of metals, shape memory materials, alloys, polymers, bioabsorbable polymers, and combinations thereof.

5. The device of claim 4, wherein said device includes nitinol.

6. The device of claim 1, wherein at least one of said first and second sides further comprises a tissue scaffold.

7. The device of claim 6, wherein said tissue scaffold includes a material selected from the group consisting of polyester fabrics, Teflon-based materials, polyurethanes, metals polyvinyl alcohol (PVA), extracellular matrix (ECM) or other bioengineered material, synthetic bioabsorbable polymeric scaffolds, collagen, and combinations thereof.

8. The device of claim 7, wherein said tissue scaffold includes nitinol.

9. The device of claim 7, wherein said tissue scaffold is attached to said loops of said at least one side.

10. The device of claim 1, wherein said first and second sides are connected by an intermediate joint.

11. The device of claim 10, wherein said intermediate joint is positioned so as to minimize distortion to the septal tissue surrounding the defect.

12. The device of claim 11, wherein said intermediate joint is positioned at an angle θ

from said second side and wherein said angle θ

is greater than 0 degrees and less than about 90 degrees.

13. A device for occluding a defect in septal tissue, comprising:

a first side adapted to be disposed on one side of septal tissue with a defect and a second side adapted to be disposed on an opposite side of the septal tissue with a defect,

an elongate center joint disposed between the first and second sides,

said first and second sides adapted to occlude the defect upon deployment at the delivery location,

said first and second sides each comprising a plurality of non-overlapping wires,

wherein said wires form loops that extend from a center axis, the loops having inner ends near to the center axis and outer ends further from the center axis, and adjacent segments of said loops are connected to each other along a generally radially extending length of the pair of adjacent segments including a point between the inner ends and the outer ends of the respective loops.

14. The device of claim 13, wherein said device is adapted to center around an asymmetrically-located defect.

15. The device of claim 13, wherein said adjacent segments are welded.

16. The device of claim 13, wherein said device includes a material selected from the group consisting of metals, shape memory materials, alloys, polymers, bioabsorbable polymers, and combinations thereof.

17. The device of claim 16, wherein said device includes nitinol.

18. The device of claim 13, wherein at least one of said first and second sides further comprises a tissue scaffold.

19. The device of claim 18, wherein said tissue scaffold includes a material selected from the group consisting of polyester fabrics, Teflon-based materials, polyurethanes, metals, polyvinyl alcohol (PVA), extracellular matrix (ECM) or other bioengineered material, synthetic bioabsorbable polymeric scaffolds, collagen, and combinations thereof.

20. The device of claim 19, wherein said tissue scaffold includes nitinol.

21. The device of claim 19, wherein said tissue scaffold is attached to said loops of said at least one side.

22. The device of claim 13, wherein said first and second sides are connected by an intermediate joint.

23. The device of claim 22, wherein said intermediate joint is positioned so as to minimize distortion to the septal tissue surrounding the defect.

24. The device of claim 23, wherein said intermediate joint is positioned at an angle θ

from said second side and wherein said angle θ

is greater than 0 degrees and less than about 90 degrees.