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

• US 8,784,448 B2
• Filed: 09/15/2008
• Issued: 07/22/2014
• Est. Priority Date: 06/05/2002
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Inventors: Chanduszko, Andrzej J.
• Primary Examiner(s): Tyson, Melanie
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US12/210,897
• Publication Number:
  US 20090012559A1
• Time in Patent Office: 2,136 Days
• Field of Search: 606/213, 606/215, 606/139, 606/151, 606/157, 600/32, 623/1.32, 623 22- 237
• 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. 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 a distal side of septal tissue with a defect and a second side adapted to be disposed on a proximal side of the septal tissue with a defect, the first side and the second side being connected by an intermediate joint;

said first and second sides adapted to occlude the defect upon deployment of the device at a delivery location; and

said first and second sides each comprising at least one wire arranged to form non-overlapping adjacent loops that are held together at the intermediate joint and extend radially from a center axis upon deployment of the device, each loop on a side having at least one radially-extending segment that is adjacent to a radially-extending segment of another loop on that side along a radial distance of the adjacent radially-extending segments;

wherein at least one pair of adjacent radially-extending segments is connected along the radial distance of the adjacent radially-extending segments, and

wherein said loops of said first and second sides are adapted to exert a compressive force on opposing sides of the septal tissue to occlude the defect; and

,

wherein the second side of the device further comprises a tip, and the wire of each loop of the second side extends radially outward from the tip, bends, and then extends back to the intermediate joint.

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 at least one pair of adjacent radially-extending 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 said first side 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 first side.

10. The device of claim 1, wherein said intermediate joint is positioned so as to minimize distortion to the septal tissue surrounding the defect.

11. The device of claim 1, 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.

12. The device of claim 1, wherein said first side comprises at least three adjacent loops having radially-extending wire segments, the three adjacent loops being attached at the intermediate joint.

13. The device of claim 12, wherein said radially-extending wire segments of said at least three adjacent loops of said first side are connected.

14. The device of claim 13, wherein said radially-extending wire segments of said at least three adjacent loops of said first side are welded.

15. The device of claim 14, wherein said first side comprises less than or equal to ten loops.

16. The device of claim 1, wherein the intermediate joint is selected from the group consisting of a weld, a solder, a tube, and a spring.

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

a first side adapted to be disposed on a distal side of septal tissue with a defect and a second side adapted to be disposed on a proximal side of the septal tissue with a defect, the first side and the second side being connected by an intermediate joint;

said first and second sides adapted to occlude the defect upon deployment of the device at a delivery location;

said first side comprising at least one wire arranged to form non-overlapping adjacent loops that extend radially from a center axis upon deployment of the device, the wire of the loops being attached at the intermediate joint, and each loop having at least one radially-extending segment that is adjacent to a radially-extending segment of another loop along a radial distance of the adjacent radially-extending segments; and

said second side comprising a tip and at least one wire arranged to form non-overlapping adjacent loops that extend radially from a center axis upon deployment of the device, the wire of the loops extending radially from the tip, bending, and then extending back to the intermediate joint, and each loop having at least one radially-extending segment that is adjacent to a radially-extending segment of another loop along a radial distance of the adjacent radially-extending segments;

wherein at least one pair of adjacent radially-extending segments of either side is connected along the radial distance of the adjacent radially-extending segments, and

wherein said loops of said first and second sides are adapted to exert a compressive force on opposing sides of the septal tissue to occlude the defect.