Paravalvular leak detection, sealing and prevention

• US 7,628,805 B2
• Filed: 08/29/2007
• Issued: 12/08/2009
• Est. Priority Date: 06/30/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Inventors: Benichou, Netanel, Spenser, Benjamin, Bash, Assaf
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/847,275
• Publication Number:
  US 20070293944A1
• Time in Patent Office: 832 Days
• Field of Search: 623 216- 238
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

The present invention provides a series of new percutaneous concepts of paravalvular repairs including identifying the leak location, several repair techniques and finally built-in means for leak prevention, built on percutaneous valves. A catheter-delivered device locates cavities occurring between a prosthetic valve and the wall of the body vessel where the valve is implanted, the cavities producing paravalvular leaks during diastole, the device comprising at least one of a plurality of flexible wires, the wire having attached to it a balloon, wherein the balloon is pulled by the leak through the cavity and wherein the wire then serves to mark the cavity location.

Claims

1. A prosthetic valve assembly for placement in a body vessel and sealing of a paravalvular leak, the valve assembly comprising:

a prosthetic valve;

a peripheral wall having an inner surface configured to support the prosthetic valve and an outer surface configured to abut the body vessel and secure the peripheral wall therein; and

a seal extending outward from at least a portion of the outer surface of the peripheral wall, the seal configured for expansion, after implantation of the peripheral wall in the body vessel, to seal the paravalvular leak between the peripheral wall and the body vessel;

wherein the seal comprises at least one impermeable tab configured to extend away from the peripheral wall upon delivery into the body vessel, wherein the seal further comprises a spring wire configured to urge the tab away from the peripheral wall, and

wherein the tab is covered with an impermeable membrane.

2. A prosthetic valve assembly of claim 1, wherein the seal comprises a material that swells upon contact with a fluid.

3. A prosthetic valve assembly of claim 2, wherein the material swells upon contact with a body fluid.

4. A prosthetic valve assembly of claim 1, wherein the seal further comprises a balloon configured to urge the tab away from the peripheral wall.

5. A prosthetic valve assembly of claim 1, wherein the seal comprises a sealing ring extending around and having a circumference greater than that of the peripheral wall.

6. A prosthetic valve assembly of claim 1, wherein the seal comprises a plurality of tabs mounted adjacent to one another around the peripheral wall and wherein the tabs are folded against the peripheral wall during delivery in a catheter and wherein, upon egress from the catheter, the tabs move away from the peripheral wall.

7. A prosthetic valve assembly of claim 1, wherein the seal comprises a plurality of tabs mounted adjacent to one another around the peripheral wall, and further comprising a balloon under the tabs and wherein the tabs are folded down on the deflated balloon during delivery in a catheter and wherein, upon egress from the catheter, the balloon is inflated and the tabs move away from the peripheral wall.

8. A prosthetic valve assembly of claim 1, wherein the seal comprises at least one of a plurality of flexible, self-expanding sealing elements comprised of self-expanding mesh covered with an impermeable membrane.

9. A prosthetic valve assembly for placement in a body vessel and sealing of a paravalvular leak, the valve assembly comprising:

a prosthetic valve;

a peripheral wall having an inner surface configured to support the prosthetic valve and an outer surface configured to abut the body vessel and secure the peripheral wall therein; and

a seal extending outward from at least a portion of the outer surface of the peripheral wall, the seal configured for expansion, after implantation of the peripheral wall in the body vessel, to seal the paravalvular leak between the peripheral wall and the body vessel;

wherein the seal comprises at least one impermeable tab configured to extend away from the peripheral wall upon delivery into the body vessel, and wherein the seal further comprises a balloon configured to urge the tab away from the peripheral wall.

10. A prosthetic valve assembly of claim 9, wherein the seal comprises a material that swells upon contact with a fluid.

11. A prosthetic valve assembly of claim 9, wherein the seal comprises a sealing ring extending around and having a circumference greater than that of the peripheral wall.

12. A prosthetic valve assembly of claim 9, wherein the seal comprises a plurality of tabs mounted adjacent to one another around the peripheral wall and wherein the tabs are folded against the peripheral wall during delivery in a catheter and wherein, upon egress from the catheter, the tabs move away from the peripheral wall.

13. A prosthetic valve assembly for placement in a body vessel and sealing of a paravalvular leak, the valve assembly comprising:

a prosthetic valve;

a peripheral wall having an inner surface configured to support the prosthetic valve and an outer surface configured to abut the body vessel and secure the peripheral wall therein; and

a seal extending outward from at least a portion of the outer surface of the peripheral wall, the seal configured for expansion, after implantation of the peripheral wall in the body vessel, to seal the paravalvular leak between the peripheral wall and the body vessel;

wherein the seal is a sealing ring extending around and having a circumference greater than that of the peripheral wall, and wherein the sealing ring comprises a balloon expandable after implantation of the peripheral wall in the body vessel.

14. A prosthetic valve assembly of claim 13, wherein the seal comprises a material that swells upon contact with a fluid.

15. A prosthetic valve assembly of claim 13, wherein the seal comprises at least one impermeable tab configured to extend away from the peripheral wall upon delivery into the body vessel.

16. A prosthetic valve assembly of claim 15, wherein the seal comprises a balloon configured to urge the tab away from the peripheral wall.

17. A prosthetic valve assembly of claim 13, wherein the seal comprises a plurality of tabs mounted adjacent to one another around the peripheral wall and wherein the tabs are folded against the peripheral wall during delivery in a catheter and wherein, upon egress from the catheter, the tabs move away from the peripheral wall.

18. A prosthetic valve assembly of claim 13, wherein the seal comprises a plurality of tabs mounted adjacent to one another around the peripheral wall, and further comprising a balloon under the tabs and wherein the tabs are folded down on the deflated balloon during delivery in a catheter and wherein, upon egress from the catheter, the balloon is inflated and the tabs move away from the peripheral wall.

19. A prosthetic valve assembly of claim 13, wherein the sealing ring comprises at least one of a plurality of flexible, self-expanding sealing elements comprised of self-expanding mesh covered with an impermeable membrane.

20. A prosthetic valve assembly for placement in a body vessel and sealing of a paravalvular leak, the valve assembly comprising:

a prosthetic valve;

a peripheral wall having an inner surface configured to support the prosthetic valve and an outer surface configured to abut the body vessel and secure the peripheral wall therein; and

a seal extending outward from at least a portion of the outer surface of the peripheral wall, the seal configured for expansion, after implantation of the peripheral wall in the body vessel, to seal the paravalvular leak between the peripheral wall and the body vessel;

wherein the seal is a sealing ring extending around and having a circumference greater than that of the peripheral wall, and

wherein the sealing ring comprises a plurality of spring-wire tabs mounted adjacent to one another around the peripheral wall and covered with an impermeable membrane and wherein the tabs are folded against the peripheral wall during delivery in a catheter and wherein, upon egress from the catheter, the tabs move away from the peripheral wall.

21. A prosthetic valve assembly of claim 20, wherein the seal comprises a material that swells upon contact with a fluid.

22. A prosthetic valve assembly of claim 20, wherein the seal further comprises a balloon configured to urge the tab away from the peripheral wall.

23. A prosthetic valve assembly for placement in a body vessel and sealing of a paravalvular leak, the valve assembly comprising:

a prosthetic valve;

a peripheral wall having an inner surface configured to support the prosthetic valve and an outer surface configured to abut the body vessel and secure the peripheral wall therein; and

a seal extending outward from at least a portion of the outer surface of the peripheral wall, the seal configured for expansion, after implantation of the peripheral wall in the body vessel, to seal the paravalvular leak between the peripheral wall and the body vessel;

wherein the seal is a sealing ring extending around and having a circumference greater than that of the peripheral wall, and

wherein the sealing ring comprises a plurality of impermeable tabs mounted adjacent to one another around the peripheral wall, and further comprising a balloon under the tabs and wherein the tabs are folded down on the deflated balloon during delivery in a catheter and wherein, upon egress from the catheter, the balloon is inflated and the tabs move away from the peripheral wall.

24. A prosthetic valve assembly for placement in a body vessel and sealing of a paravalvular leak, the valve assembly comprising:

a prosthetic valve;

a peripheral wall having an inner surface configured to support the prosthetic valve and an outer surface configured to abut the body vessel and secure the peripheral wall therein; and

a seal extending outward from at least a portion of the outer surface of the peripheral wall, the seal configured for expansion, after implantation of the peripheral wall in the body vessel, to seal the paravalvular leak between the peripheral wall and the body vessel;

wherein the seal is a sealing ring extending around and having a circumference greater than that of the peripheral wall, and

wherein the sealing ring comprises a plurality of impermeable tabs mounted adjacent to one another around the peripheral wall, each tab spring-hinged to the peripheral wall and wherein the tabs are folded against the peripheral wall during catheter delivery and wherein, upon egress from the catheter, the tabs spring out from the peripheral wall.

25. A prosthetic valve assembly for placement in a body vessel and sealing of a paravalvular leak, the valve assembly comprising:

a prosthetic valve;

a peripheral wall having an inner surface configured to support the prosthetic valve and an outer surface configured to abut the body vessel and secure the peripheral wall therein; and

a seal extending outward from at least a portion of the outer surface of the peripheral wall, the seal configured for expansion, after implantation of the peripheral wall in the body vessel, to seal the paravalvular leak between the peripheral wall and the body vessel;

wherein the seal is a sealing ring extending around and having a circumference greater than that of the peripheral wall, and

wherein the sealing ring comprises at least one of a plurality of flexible, self-expanding sealing elements comprised of self-expanding mesh covered with an impermeable membrane.

26. A prosthetic valve assembly of claim 25, wherein the seal comprises a material that swells upon contact with a fluid.

27. A method of implanting a prosthetic valve assembly, the method comprising:

implanting a peripheral wall and prosthetic valve surrounded and supported by the peripheral wall into a body vessel; and

after implanting the peripheral wall, expanding a seal supported on an outside surface of the peripheral wall to seal a paravalvular leak;

wherein expanding the seal includes expanding a balloon of the seal.

28. A method of claim 27, wherein expanding the seal includes swelling a seal material with a fluid.

29. A method of claim 27, wherein expanding the seal includes urging an impermeable tab away from the peripheral wall.

30. A method of claim 27, wherein expanding the seal includes swelling a seal material with a fluid.

31. A method of implanting a prosthetic valve assembly, the method comprising:

implanting a peripheral wall and prosthetic valve surrounded and supported by the peripheral wall into a body vessel; and

after implanting the peripheral wall, expanding a seal supported on an outside surface of the peripheral wall to seal a paravalvular leak;

wherein expanding the seal includes urging an impermeable tab away from the peripheral wall, and wherein urging the impermeable tab includes inflating a balloon supporting the tab.

32. A method of claim 31, wherein expanding the seal includes swelling a seal material with a fluid.

33. A method of implanting a prosthetic valve assembly, the method comprising:

implanting a peripheral wall and prosthetic valve surrounded and supported by the peripheral wall into a body vessel; and

,

after implanting the peripheral wall, expanding a substantially toroidal-shaped seal supported on and substantially around an outside surface of an extreme inlet end of the peripheral wall to seal a paravalvular leak;

wherein expanding the seal includes urging an impermeable tab away from the peripheral wall;

wherein urging the impermeable tab includes extending a spring supporting the tab.

34. A method of claim 33, wherein expanding the seal includes expanding the seal in a ring configuration extending around the peripheral wall.

35. A method of claim 33, wherein implanting the peripheral wall includes releasing the peripheral wall from a catheter.