Patent foramen ovale (PFO) closure method and device

• US 7,220,265 B2
• Filed: 01/14/2003
• Issued: 05/22/2007
• Est. Priority Date: 01/14/2002
• Status: Expired due to Fees

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: NMT Medical Incorporated
• Inventors: Opolski, Steven W., Ryan, Carol A., Chanduszko, Andrzej J.
• Primary Examiner(s): Hayes; Michael J.
• Assistant Examiner(s): Bachman; L.
• Application Number:
  US10/341,802
• Publication Number:
  US 20030144694A1
• Time in Patent Office: 1,589 Days
• Field of Search: 606/139, 606/151
• US Class Current: 606/139
• 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 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00867 shape memory effect

Abstract

The present invention provides methods and devices for closing two overlapping layers of tissue in a mammalian heart, for example a patent foramen ovale (PFO). The closure devices may take a number of different forms and may be retrievable. In some embodiments, the closure devices may be delivered with a catheter capable of puncturing mammalian tissue.

Claims

1. A method of closing septum primum and septum secundum in a mammalian heart, comprising:

(a) inserting a closure device into a right atrium of said heart, said device including first and second ends;

(b) puncturing septum primum and passing said first end of said first end of said closure device through septum primum into a left atrium of said heart;

(c) puncturing septum secundum with said first end of said closure device after said closure device has passed through septum primum; and

(d) positioning said second end of said closure device against septum secundum in the right atrium such that said closure device provides a compressive force to compress at least one of septum primum and septum secundum therebetween.

2. The method of claim 1, wherein said closure device is delivered with a catheter that includes a septal puncture needle capable of puncturing mammalian tissue.

3. The method of claim 2, wherein puncturing septum secundum includes puncturing so that said first end is embedded in and does not extend through septum secundum.

4. The method of claim 3, wherein said puncturing includes the septal needle catheter puncturing septum secundum in multiple locations simultaneously, the method further comprising embedding a plurality of pieces of the closure device in septum secundum.

5. The method of claim 2, wherein puncturing septum secundum includes completely puncturing septum secundum so that said first end extends into the right atrium.

6. The method of claim 5, wherein said puncturing includes the septal needle catheter puncturing septum secundum in multiple locations simultaneously, the method further comprising deploying a plurality of pieces of the closure device into the right atrium.

7. The method of claim 1, wherein said puncturing septum primum and passing a portion of said closure device through septum primum constitutes one step.

8. The method of claim 1, wherein said puncturing septum primum and passing a portion of said closure device through septum primum constitutes two steps.

9. The method of claim 1, wherein said first end of said closure device includes a shape memory material.

10. The method of claim 9, wherein said shape memory material includes nitinol.

11. The method of claim 1, wherein said closure device is formed of a material selected from the group consisting of bioresorbable materials, noble metals, shape memory materials, metals, polymeric materials, or swellable foams.

12. The method of claim 1, wherein said first end is formed into a coil, hook, corkscrew, or other anchor.

13. The method of claim 1, wherein said second end is formed into a knot, coil, spiral, or other adjustable mechanism sufficient to hold said closure device in place.

14. The method of claim 1, wherein said second end of said closure device has a structure that is adjustable to alter the compressive force applied to septum primum and septum secundum.

15. The method of claim 1, wherein steps (a) through (d) are repeated at least once for multiple closure devices.

16. The method of claim 1, wherein said closure device is shaped as a ring with a gap, the ring being positioned so that said first end punctures and embeds into said septum secundum on the left atrium side and said second end punctures and embeds into said septum secundum on the right atrium side, said septum secundum being compressed in said gap.

17. The method of claim 16, wherein said ring consists of a single monolithic piece.

18. The method of claim 16, wherein said inserting includes providing the closure device in a catheter, said closure device being elongated so that the gap between said first and second ends is enlarged.

19. The method of claim 1, wherein said closure device is shaped as a ring with first and second ends and at least one fold therebetween, said ring being positioned so that said first and second ends puncture septum secundum on the left atrium side and said at least one fold contacts septum secundum in the right atrium, septum secundum being compressed between said first and second ends and said at least one fold.

20. The method of claim 1, wherein the device has a first piece including said first end, and a separate second piece including said second end, said first and second pieces connected together at a location in the right atrium, at least one of said pieces being curved relative to the other said piece.

21. The method of claim 20, wherein said first piece is convex relative to septum secundum and said second piece is concave relative to septum secundum.

22. The method of claim 20, further comprising retrieving and removing said closure device after it has been deployed.

23. The method of claim 1, further comprising retrieving and removing said closure device after it has been deployed.

24. The method of claim 1, wherein said closure device includes a grappling hook member joined to at least one curved arm by an enlarged-tip joinder member, said grappling hook member is connected to an elongate tether, said grappling hook member including at least one grappling hook capable of being reversibly and distally elongated, wherein puncturing septum secundum includes deploying said grappling hook member such that said at least one grappling hook is embedded into the surface of septum secundum in the left atrium, applying tension to said tether such that said grappling hook draws septum secundum into contact with septum primum, and said positioning includes deploying said at least one curved arm such that said curved arm engages the surface of septum secundum exposed in the right atrium.

25. The method of claim 24, wherein said grappling hook member includes a plurality of grappling hooks and, upon deploying said grappling hook member in the left atrium, said plurality of grappling hooks are embedded in the surfaces of both septum primum and septum secundum in the left atrium.

26. The method of claim 25, wherein said closure device includes a plurality of curved arms and, upon deployment in the right atrium, said plurality of curved arms engage both the surfaces of septum primum and septum secundum exposed in the right atrium.

27. The method of claim 24, wherein said inserting includes providing the closure device in a catheter, said closure device being elongated such that said first and second ends are distally elongated relative to said joinder member.

28. The method of claim 24, further comprising retrieving said closure device after a period of time sufficient to allow septum primum and septum secundum to fuse together by grabbing said joinder member with a removal device and withdrawing said grappling hook member of said closure device through septum primum.

29. The method of claim 24, further comprising withdrawing said catheter from said heart and attaching said tether to a subcutaneous button and retrieving said closure device after a period of time sufficient to allow septum primum and septum secundum to fuse together by pulling said device through septum primum and into a recovery sheath by means of the tether.