MEDICAL DEVICE FOR PERCUTANEOUS PARAVALVULAR LEAK AND RELATED SYSTEMS AND METHODS

• US 20090112311A1
• Filed: 10/17/2008
• Published: 04/30/2009
• Est. Priority Date: 10/19/2007
• Status: Abandoned Application

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Miles, Scott D., Davis, Clark C., Linder, Richard J.
• Application Number:
  US12/253,882
• Publication Number:
  US 20090112311A1
• Time in Patent Office: Days
• US Class Current: 623/2.380
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

The present invention provides devices, systems and methods for closing a paravalvular leak. In accordance with one embodiment, a medical device includes at least one multicellular frame member configured to be implanted at a paravalvular leak. The medical device further includes at least one tissue in-growth member associated with the frame member, the tissue in-growth member being configured to promote tissue growth and permanently maintain the frame member at the leak. The frame member may be self expanding device formed, for example, of a shape-memory alloy. The tissue in-growth member may be formed from a polymer material. In one particular embodiment, the frame member may be a substantially tubular structure and the tissue in-growth member may be disposed within an interior space defined by the tubular structure. In another embodiment, the frame ember may be a substantially flat or planar structure.

Claims

1. A medical device for repairing a paravalvular leak, comprising:

at least one multicellular frame member configured to be implanted at a paravalvular leak; and

at least one tissue in-growth member associated with the frame member, the tissue in-growth member configured to promote tissue growth and permanently maintain the frame member at the leak.

2. The medical device of claim 1, wherein the at least one multicellular frame member is a substantially tubular structure.

3. The medical device of claim 1, wherein the at least one tissue in-growth member is disposed within an internal space defined by the substantially tubular structure.

4. The medical device of claim 3, wherein the at least one multicellular frame member is formed of a material comprising a shape memory alloy.

5. The medical device of claim 4, wherein the shape memory alloy comprises a nickel-titanium alloy.

6. The medical device of claim 1, wherein the at least one tissue in-growth material is formed of a polymer material.

7. The medical device of claim 1, wherein the at least one multicellular frame member is a substantially planar structure.

8. The medical device of claim 7, wherein the at least one multicellular frame member is formed of a material comprising a shape-memory alloy.

9. The medical device of claim 1, further comprising a plurality of tines associated with the at least one multicellular frame member, the plurality of tines being configured to engage a wall of a valvular leak and anchor the medical device relative thereto.

10. The medical device of claim 1, wherein the at least one multi-cellular frame member comprises a first frame member and a second frame member, and wherein the at least one tissue in-growth member is disposed between the first frame member and the second frame member.

11. The medical device of claim 10, wherein the first frame member and the second frame member are substantially planar members and are arranged to lie in substantially parallel planes.

12. A method of closing a paravalvular leak, the method comprising:

disposing a multicellular frame member within the paravalvular leak; and

disposing a tissue in-growth member within the paravalvular leak at a location adjacent the multicellular frame member to promote tissue growth and permanently maintain the frame member at the leak.

13. The method according to claim 12, wherein disposing a multicellular frame member within the paravalvular leak and disposing a tissue in-growth member within the paravalvular leak occurs substantially simultaneously.

14. The method according to claim 12, wherein disposing a multicellular structure includes disposing a self expanding structure within the paravalvular leak.

15. The method according to claim 12, wherein disposing a self expanding structure includes disposing a substantially planar structure within the paravalvular leak.

16. The method according to claim 12, wherein disposing a self expanding structure includes disposing a substantially tubular structure within the paravalvular leak.

17. The method according to claim 14, wherein disposing a tissue in-growth member includes disposing the tissue in-growth member within an inner space defined by the substantially tubular structure.

18. The method according to claim 15, wherein disposing a tissue in-growth member within the paravalvular leak further comprises disposing a foam material within the paravalvular leak.

19. The method according to claim 12, wherein disposing a multicellular frame member within the paravalvular leak and disposing a tissue in-growth member within the paravalvular leak further comprises disposing a first frame member and a second frame member, with the tissue in-growth member disposed between the first and second frame members, within the paravalvular leak.

20. The method according to claim 19, further comprising configuring the first and second frame members to be substantially planar members and arranging the first and second frame members to lie in substantially parallel planes.

21. A medical device for repairing a paravalvular leak, comprising:

a frame member having at least two elongated arms biased in two different directions; and

a tissue in-growth member configured to be attached to the frame member to promote tissue growth and permanently seal the leak.

22. The medical device of claim 21, wherein the at least two different directions include a first direction and a second direction that is substantially opposite of the first direction.

23. The medical device of claim 21, wherein the at least two elongate arms include a first pair of elongated arms and a second pair of elongated arms.

24. The medical device of claim 21, wherein the frame member is formed of a material comprising a shape-memory alloy.

25. The medical device of claim 24, wherein the shape-memory alloy comprises a nickel-titanium alloy.

26. The medical device of claim 24, wherein the tissue in-growth member is formed of a polymer material.