Device and method for treatment of heart valve regurgitation

• US 20060058871A1
• Filed: 09/14/2005
• Published: 03/16/2006
• Est. Priority Date: 09/14/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Zakay, Avraham, Rottenberg, Dan, Mishaly, David, Alon, David
• Granted Patent: US 7,704,277 B2
• Time in Patent Office: Days
• US Class Current: 623/2.180
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2210/0066 shrinkable

Abstract

In one embodiment, the present invention provides a prosthesis that can be implanted within a heart to at least partially block gaps that may be present between the two mitral valve leaflets. In one preferred embodiment, the prosthesis includes an anchoring ring that expands within the left atrium to anchor the prosthesis and a pocket member fixed to the anchoring ring. The pocket member is positioned within the mitral valve, between the leaflets so that an open end of the pocket member is positioned within the left ventricle. When the mitral valve is open, blood flows past the pocket member, maintaining the pocket member in a collapsed state. When the mitral valve closes, the backpressure of the blood pushes into the pocket member, expanding the pocket member to an inflated shape. The mitral valve leaflets contact the expanded pocket member, allowing the prosthesis to block at least a portion of the openings between the leaflets, thereby minimizing regurgitated blood flow into the left atrium.

Claims

1. A device for treating valve regurgitation comprising:

a coaptation member sized for placement at least partially between leaflets of a valve, said coaptation member having an expanded state and a deflated state and having a length substantially equal to a commissure of said leaflets; and

an anchoring structure connected to said coaptation member, said anchoring structure having a compressed state sized to ft within a delivery catheter and an expanded state sized for fixation on at least a portion of a wall of a chamber adjacent said valve.

2. The device of claim 1, wherein said coaptation member includes a flexible pocket, said flexible pocket comprised of flexible material disposed on a support structure wherein said support structure is sized to urge said flexible material along a length of said commissure.

3. The device of claim 2, wherein said flexible material is pericardial tissue.

4. The device of claim 1, wherein said anchoring structure is comprised of an anchoring wire.

5. The device of claim 4, wherein said anchoring wire is shaped for fixation against a wall of a left atrium.

6. The device of claim 4, wherein said anchoring wire is shaped to contact a mitral valve annulus.

7. The device of claim 1, wherein said anchoring structure is sized to conform substantially to a portion of a left atrium.

8. The device of claim 1, wherein said anchoring structure is rotatably connected to said coaptation member.

9. The device of claim 1, wherein said anchoring structure is size for fixation on an atrial septum.

10. The device of claim 1, wherein said anchoring structure is comprised of a stent portion.

11. The device of claim 1, wherein said anchoring structure includes a ring.

12. The device of claim 1, wherein said anchoring structure includes a plurality of loops.

13. The device of claim 1, wherein said anchoring structure includes a wire having a plurality of curved portions.

14. The device of claim 1, wherein said anchoring structure includes an anchoring cage.

15. The device of claim 1, wherein said anchoring structure includes a first anchoring member having an expanded shape sized for fixation against said portion of a wall of a chamber adjacent to said valve, and a second anchoring member having an expanded shape sized for fixation against a valve annulus.

16. A method of treating valve regurgitation comprising:

loading a prosthesis within a delivery catheter, said prosthesis including an anchoring portion and a coaptation portion,

advancing said delivery catheter to a chamber of a heart;

deploying said coaptation portion within a valve;

expanding said anchoring portion to contact a wall of said chamber; and

supporting said coaptation portion within a commisure of said valve.

17. A method of claim 16, further comprising:

expanding said coaptation portion during systole; and

deflating said coaptation portion during diastole.

18. A method of claim 16, wherein the deploying of said coaptation within a valve includes deploying said coaptation portion within a mitral valve.

19. The method of claim 16, wherein said deploying said coaptation portion within said valve includes aligning a length of said coaptation portion along a commissure of said valve.

20. The method of claim 17, wherein said expanding said coaptation portion during systole includes filling said coaptation portion with blood.

21. The method of claim 17, wherein said deflating said coaptation portion during diastole includes removing blood from said coaptation portion.

22. The method of claim 17, wherein said expanding said coaptation portion during systole includes substantially blocking blood flow along a length of a mitral valve leaflet.

23. The method of claim 16, wherein said expanding said anchoring portion to contact a wall of said chamber further includes expanding said anchoring portion to contact a valve annulus.

24. The method of claim 16, wherein said expanding said anchoring portion to contact a wall of said chamber includes expanding a first region of said anchoring portion to contact a first location within said chamber and expanding a second region of said anchoring portion to contact a second location within said chamber.

25. A device for substantially blocking blood flow in a valve during systole comprising:

a flexible member having a lateral dimension;

a support member coupled to said flexible member and shaped to position said lateral dimension of said flexible member along a commissural length of a leaflet of said valve;

an anchoring member coupled to said support member, said anchoring member including a compressed configuration and an expanded configuration;

wherein said expanded configuration of said anchoring member is shaped to position said support member at least partially within said valve.

26. The device of claim 25, wherein said flexible member includes an expanded state and a deflated state.

27. The device of claim 26, wherein said flexible member is a solid and flexible plate member.

28. The device of claim 27, wherein said flexible member is comprised of pericardial tissue.

29. The device of claim 25, wherein said flexible member includes a cavity.

30. The device of claim 29, wherein said cavity includes an opening positioned towards a left ventricle.

31. The device of claim 25, wherein said flexible member comprises pericardial tissue.

32. The device of claim 25, wherein said support member is comprised of a wire.

33. The device of claim 25, wherein said anchoring member is comprised of an anchoring wire.

34. The device of claim 33, wherein said anchoring wire is shaped for fixation against a wall of a left atrium.

35. The device of claim 33, wherein said anchoring wire is shaped to contact a mitral valve annulus.

36. The device of claim 25, wherein said anchoring member is sized to conform substantially to a portion of a left atrium.

37. The device of claim 25, wherein said anchoring member is rotatable connected to said flexible member.

38. The device of claim 25, wherein said anchoring member is comprised of a stent portion.

39. The device of claim 25, wherein said anchoring member includes a ring.

40. The device of claim 25, wherein said anchoring member includes a plurality of loops.

41. The device of claim 25, wherein said anchoring member includes a wire having a plurality of curved portions.

42. The device of claim 25, wherein said anchoring member comprises an anchoring cage.

43. The device of claim 25, wherein said anchoring member includes a first anchoring member having an expanded shape sized for fixation against a portion of a wall of a chamber adjacent to said valve, and a second anchoring member having an expanded shape sized for fixation against a valve annulus.

44. The device of claim 25, wherein said anchoring member is configured to be at least partially anchored within an atrial septum.