Apparatus and method for replacing a cardiac valve

• US 20060259135A1
• Filed: 04/20/2006
• Published: 11/16/2006
• Est. Priority Date: 04/20/2005
• Status: Abandoned Application

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Navia, Jose L., Navia, Jose A., Oberti, Carlos
• Application Number:
  US11/408,756
• Publication Number:
  US 20060259135A1
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

An apparatus for replacing a cardiac valve having at least two native valve leaflets includes an expandable support member with oppositely disposed first and second ends and a main body portion extending between the ends. The first and second ends respectively include a plurality of upper and lower wing members respectively having first and second magnetic components. The wing members extend from the main body portion and are spaced circumferentially thereabout. Secured within the main body portion is a prosthetic valve having at least two valve leaflets. The second end further includes at least two strut members spaced apart from each other and attached to at least one commissural section of the prosthetic valve. The magnetic components are magnetically attracted to one another so that, when the apparatus is placed in the valve annulus, the wing members are pulled toward one another to secure the prosthetic valve in the annulus.

Claims

1. An apparatus for replacing a cardiac valve having at least two native valve leaflets, said apparatus comprising:

an expandable support member having oppositely disposed first and second ends and a main body portion extending between said ends, said main body portion of said expandable support member having an annular shape for expanding into position in the annulus of the cardiac valve;

said first end of said expandable support member comprising a plurality of upper wing members that extend from said main body portion and are spaced circumferentially apart about said main body portion, each of said upper wing members having a first magnetic component;

said second end of said expandable support member comprising a plurality of lower wing members that extend from said main body portion, each of said lower wing members having a second magnetic component;

said second end of said expandable support member further including at least two strut members that are spaced apart from each other;

said first and second magnetic components being magnetically attracted to one another so that, when said apparatus is placed in the annulus of the cardiac valve, said upper and lower wing members are pulled toward one another to secure said expandable support member in the annulus; and

a prosthetic valve secured within said main body portion of said expandable support member, said prosthetic valve having at least two valve leaflets that are coaptable to permit unidirectional flow of blood, each of said at least two valve leaflets being joined together at at least two commissural sections that are spaced apart from each other, each of said at least two commissural sections being attached to a respective one of said strut members to prevent prolapse of said valve leaflets.

2. The apparatus of claim 1 wherein said main body portion further comprises a first end portion and a second end portion, said first and second end portions respectively having first and second magnetic ring components.

3. The apparatus of claim 1 wherein said plurality of lower wing members includes first and second lower wing members for positioning at the commissures of the cardiac valve.

4. The apparatus of claim 3 wherein said plurality of lower wing members further includes third and fourth lower wing members for positioning directly over respective central portions of the at least two native valve leaflets.

5. The apparatus of claim 1 wherein at least one of said upper and lower wing members each include at least one attachment mechanism for securing said expandable support member in the annulus of the cardiac valve.

6. The apparatus of claim 5 wherein said at least one attachment mechanism includes at least one barb.

7. The apparatus of claim 1 wherein at least a portion of said expandable support member is covered with a layer of biocompatible material.

8. The apparatus of claim 1 wherein at least a portion of said apparatus is comprised of a bioabsorbable material.

9. The apparatus of claim 1 wherein at least a portion of said expandable support member is treated with at least one therapeutic agent for eluting into cardiac tissue or a cardiac chamber.

10. The apparatus of claim 1 wherein a plurality of portions of said expandable support member are separately treated with a different one of said at least one therapeutic agent.

11. The apparatus of claim 10 wherein said main body portion and said wing members are each separately treated with a different one of said at least one therapeutic agent.

12. The apparatus of claim 10 wherein each of said wing members is separately treated with a different one of said at least one therapeutic agent.

13. A method for replacing a cardiac valve having at least two native valve leaflets, said method comprising the steps of:

providing a prosthetic valve that includes an expandable support member having a main body portion, a plurality of upper wing members that extend from a first end of the main body portion and which include a first magnetic component attached to each upper wing member, and a corresponding plurality of lower wing members that extend from an opposite second end of the main body portion and which include a second magnetic component attached to each lower wing member, the second end of the expandable support member further including at least two strut members, the prosthetic valve having at least two valve leaflets that are joined together at at least two commissural sections, each of the at least two commissural sections being attached to a respective one of the strut members to prevent prolapse of the valve leaflets, the prosthetic valve having at least two valve leaflets that are coaptable to permit unidirectional flow of blood;

placing the main body portion of the prosthetic valve within the annulus of the cardiac valve to be replaced;

expanding the main body portion into engagement with the annulus of the cardiac valve to secure the prosthetic valve in the annulus; and

deploying the upper and lower wing members from a radially collapsed condition into a radially extended condition whereby the first and second magnetic components are magnetically attracted and pull the upper and lower wing members toward each other, which secures the prosthetic valve in the annulus of the native cardiac valve.

14. The method of claim 13 wherein said step of placing the main body portion of the prosthetic valve within the annulus of the cardiac valve to be replaced further comprises the steps of:

placing the expandable support member around an inflatable balloon in a secured manner;

inserting the balloon and expandable support member into an atrial chamber;

advancing the balloon until the expandable support member is positioned within the annulus of the cardiac valve to be replaced; and

expanding the expandable support member with the balloon so that the expandable support member engages the annulus of the cardiac valve to secure the expandable support member in the annulus.

15. The method of claim 14 wherein said step of inserting the balloon and the expandable support member into the atrial chamber is done percutaneously via an intravascular catheter.

16. The method of claim 14 wherein said step of inserting the balloon and the expandable support member into the atrial chamber is done via a minimally invasive, transthoracic approach via a port on the heart wall.

17. The method of claim 14 wherein said step of inserting the balloon and the expandable support member into the atrial chamber is done via an open-chest procedure under direct supervision.

18. The method of claim 13 wherein at least a portion of the expandable support member is treated with at least one therapeutic agent for eluting into cardiac tissue or a cardiac chamber, said method further comprising the step of allowing the at least one therapeutic agent to elute into the cardiac tissue or the cardiac chamber.

19. The method of claim 13 wherein a plurality of portions of the expandable support member are separately treated with a different one of the at least one therapeutic agent.

20. The method of claim 19 wherein the main body portion and the wing members are each separately treated with a different one of the at least one therapeutic agent.

21. The method of claim 19 wherein each of the wing members is separately treated with a different one of the at least one therapeutic agent.

22. The method of claim 13 wherein at least one of the upper and lower wing members each include at least one attachment mechanism for securing the expandable support member in the annulus of the cardiac valve.

23. The method of claim 13 wherein the main body portion further comprises a first end portion and a second end portion, the first and second end portions respectively having first and second magnetic ring components.

24. The method of claim 13 wherein the upper and lower wing members respectively include third and fourth magnetic ring components.

25. An apparatus for replacing a cardiac valve having at least two native valve leaflets, said apparatus comprising:

an expandable support member having oppositely disposed first and second ends and a main body portion extending between said ends, said main body portion of said expandable support member having an annular shape for expanding into position in the annulus of the cardiac valve, said first end of said expandable support member comprising a plurality of upper wing members that extend from said main body portion, said second end of said expandable support member comprising a plurality of lower wing members that extend from said main body portion, said second end of said expandable support member further including at least two strut members that are spaced apart from each other;

said upper and lower wing members including means for magnetically attracting upper and lower wing members toward each other to secure said apparatus in the annulus of the native cardiac valve; and

a prosthetic valve secured within said main body portion of said expandable support member, said prosthetic valve having at least two valve leaflets that are coaptable to permit unidirectional flow of blood, each of said at least two valve leaflets being joined together at at least two commissural sections that are spaced apart from each other, each of said at least two commissural sections being attached to a respective one of said strut members to prevent prolapse of said valve leaflets.

26. The apparatus of claim 25 wherein said means for magnetically attracting upper and lower wing members includes at least one magnetized wire.

27. The apparatus of claim 25 wherein said plurality of lower wing members includes first and second lower wing members for positioning at the commissures of the cardiac valve.

28. The apparatus of claim 27 wherein said plurality of lower wing members further includes third and fourth lower wing members for positioning directly over respective central portions of the at least two native valve leaflets.

29. The apparatus of claim 25 wherein at least a portion of said expandable support member is covered with a layer of biocompatible material.

30. The apparatus of claim 25 wherein at least a portion of said expandable support member is treated with at least one therapeutic agent for eluting into cardiac tissue or a cardiac chamber.

31. The apparatus of claim 25 wherein a plurality of portions of said expandable support member are separately treated with a different one of said at least one therapeutic agent.

32. The apparatus of claim 31 wherein said main body portion and said wing members are each separately treated with a different one of said at least one therapeutic agent.

33. The apparatus of claim 31 wherein each of said wing members is separately treated with a different one of said at least one therapeutic agent.

34. The apparatus of claim 25 wherein at least one of said upper and lower wing members each include at least one attachment mechanism for securing said expandable support member in the annulus of the cardiac valve.

35. An apparatus for replacing a cardiac valve having at least two native valve leaflets, said apparatus comprising:

an expandable support member having oppositely disposed first and second ends and a main body portion extending between said ends, said main body portion having an annular shape for expanding into position in the annulus of the cardiac valve;

said first and second ends of said expandable support member respectively comprising a plurality of upper and lower wing members that extend from said main body portion and are spaced circumferentially apart about said main body portion, each of said upper and lower wing members having at least one attachment mechanism;

said second end of said expandable support member further including at least two strut members that are spaced apart from each other;

said main body portion comprising a first end portion and a second end portion, said first and second end portions respectively having first and second magnetic ring components;

said first and second magnetic ring components being magnetically attracted to one another so that, when said apparatus is placed in the annulus of the cardiac valve, said first and second end portions of said main body portion are pulled toward one another to secure said expandable support member in the annulus; and

a prosthetic valve secured within said main body portion of said expandable support member, said prosthetic valve having at least two valve leaflets that are coaptable to permit unidirectional flow of blood, each of said at least two valve leaflets being joined together at at least two commissural sections that are spaced apart from each other, each of said at least two commissural sections being attached to a respective one of said strut members to prevent prolapse of said valve leaflets.

36. The apparatus of claim 35 wherein said upper and lower wing members respectively include third and fourth magnetic ring components, said third and fourth magnetic ring components being magnetically attracted to one another so that, when said apparatus is placed in the annulus of the cardiac valve, said third and fourth magnetic ring components are pulled toward one another to secure said expandable support member in the annulus.

37. The apparatus of claim 35 wherein said plurality of lower wing members includes first and second lower wing members for positioning at the commissures of the cardiac valve.

38. The apparatus of claim 37 wherein said plurality of lower wing members further includes third and fourth lower wing members for positioning directly over respective central portions of the at least two native valve leaflets.

39. The apparatus of claim 35 wherein said at least one attachment mechanism of said upper wing members is for embedding into a section of cardiac tissue to help secure said expandable support member in the annulus of the cardiac valve.

40. The apparatus of claim 35 wherein said at least one attachment mechanism of said lower wing members is for embedding into a portion of the native valve leaflets to help secure said expandable support member in the annulus of the cardiac valve.

41. The apparatus of claim 35 wherein at least a portion of said expandable support member is covered with a layer of biocompatible material.

42. The apparatus of claim 35 wherein at least a portion of said expandable support member is treated with at least one therapeutic agent for eluting into cardiac tissue or a cardiac chamber.

43. The apparatus of claim 35 wherein a plurality of portions of said expandable support member are separately treated with a different one of said at least one therapeutic agent.

44. The apparatus of claim 43 wherein said main body portion and said wing members are each separately treated with a different one of said at least one therapeutic agent.

45. The apparatus of claim 43 wherein each of said wing members is separately treated with a different one of said at least one therapeutic agent.