Removable intracardiac RF device

• US 8,795,329 B2
• Filed: 08/15/2010
• Issued: 08/05/2014
• Est. Priority Date: 09/06/2005
• 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: Forde, Sean, Scutti, James, Callaghan, David J., Glaser, Erik, Devellian, Carol A., Opolski, Steve W
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US12/856,654
• Publication Number:
  US 20100312236A1
• Time in Patent Office: 1,451 Days
• Field of Search: 607/116, 606 32- 52, 606/213, 623 11- 154, 623/13.17, 623/13.18, 623/23.72
• US Class Current: 606/213
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• 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 2018/00351 Heart
• CPC Class Codes: A61B 2018/1435 Spiral

Abstract

The present invention provides systems and methods for occluding or closing a patent foramen ovale of a patient (PFO). The invention includes a catheter carrying an energy delivery element. The catheter introduces the energy delivery element into the patent foramen ovale of a patient'"'"'s heart. Once appropriately positioned, the energy delivery element applies energy, such as radiofrequency energy, to the tissues surrounding the patent foramen ovale. The application of energy causes the tissues to join together, occluding the patent foramen ovale. The energy delivery element may be removable or permanently implanted in the patent foramen ovale.

Claims

1. A medical device for occluding the tunnel of a patent foramen ovale (PFO) in a patient comprising:

an occluding member, a sheath comprising a lumen;

an elongated member, one of said elongated member and said sheath axially moveable relative to the other; and

an energy delivering element comprising a plug comprising animal tissue and joined to said elongated member, wherein said plug comprises a core member sized and shaped to substantially fill the tunnel of the PFO, and wherein further the occluding member comprises a proximal occluder including a plurality of outwardly extending proximal arms supporting a proximal occlusion shell and a distal occluder including a plurality of outwardly extending distal arms supporting a distal occlusion shell and a centering mechanism secured between said proximal occluder and said distal occluder to center said proximal and said distal occluders about a defect, said centering mechanism comprising at least two centering members, each of said centering members secured between a separate one of said proximal arms and a corresponding one of said distal arms, at least one of said centering members comprising an elastomeric material.

2. The device of claim 1, wherein said plug comprises a resorbable material.

3. The device of claim 1, wherein said plug is expandable.

4. The device of claim 3, wherein said plug is expandable upon application of energy to the plug.

5. The device of claim 1, wherein the energy delivering element delivers RF energy.

6. The device of claim 5, wherein the RF energy is supplied to one or more points on said plug.

7. The device of claim 5, wherein the RF energy is supplied along one or more linear pathways of the plug.

8. The device of claim 5, wherein the RF energy is supplied to the entire plug.

9. The device of claim 1, wherein the occluding member comprises a bioabsorbable material.

10. The device of claim 1, wherein the plug further comprises a sleeve or coating which bonds to tissue of the PFO upon application of energy.

11. The device of claim 1, wherein the sleeve or coating comprises a material from the group consisting of a bioabsorbable material, a polymer, and a metal.

12. The device of claim 1, wherein the sleeve or coating comprises one or more substances for stimulating tissue growth.

13. The device of claim 1, wherein the occluding member comprises a spiral shaped device.

14. The device of claim 1, wherein the occluding member comprises nitinol or a bioabsorbable material.

15. The device of claim 1, wherein the plug further comprises a shape memory alloy.

16. The device of claim 15 wherein the shape memory alloy is nitinol.