APPARATUS AND METHOD FOR TREATING A REGURGITANT HEART VALVE

• US 20090132036A1
• Filed: 11/19/2008
• Published: 05/21/2009
• Est. Priority Date: 11/19/2007
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Navia, Jose Luis
• Granted Patent: US 8,216,303 B2
• Time in Patent Office: Days
• US Class Current: 623/2.360
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• 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 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

An apparatus is provided for treating regurgitation of blood flow through a diseased heart valve. The apparatus includes an annular support member and at least one posterior leaflet support member. The annular support member has an anterior end portion, a posterior end portion, and oppositely disposed first and second intermediate portions extending between the end portions. The at least one posterior leaflet support member is securely connected to the annular support member and is dimensioned to extend across a portion of a free edge of a posterior valve leaflet. The posterior leaflet support member comprises an arcuate center portion integrally formed with and extending between first and second end portions. The arcuate center portion has a concave shape relative to the anterior end portion. At least one of the first and second end portions is securely attached to the posterior end portion.

Claims

1. An apparatus for treating regurgitation of blood flow through a diseased heart valve, the diseased heart valve including an annulus, an anterior valve leaflet, and a posterior valve leaflet, each of the anterior and posterior valve leaflets having a free edge, said apparatus comprising:

an annular support member having an anterior end portion, a posterior end portion, and oppositely disposed first and second intermediate portions extending between said anterior and posterior end portions, said annular support member being dimensioned for attachment to the annulus of the heart valve; and

at least one posterior leaflet support member securely connected to said annular support member and being dimensioned to extend across a portion of the free edge of the posterior valve leaflet;

said posterior leaflet support member comprising an arcuate center portion integrally formed with and extending between first and second end portions, said arcuate center portion having a concave shape relative to said anterior end portion, at least one of said first and second end portions being securely attached to said posterior end portion.

2. The apparatus of claim 1, wherein said first and second end portions of said posterior leaflet support member are securely attached to said first intermediate portion and said posterior end portion of said annular support member, respectively.

3. The apparatus of claim 1, wherein said first and second end portions of said posterior leaflet support member are securely attached to said posterior end portion and said second intermediate portion of said annular support member, respectively.

4. The apparatus of claim 1, wherein each of said first and second end portions of said posterior leaflet support member has a concave shape relative to said anterior end portion of said annular support member.

5. The apparatus of claim 1, wherein each of said first and second end portion of said posterior leaflet support member has a convex shape relative to said anterior end portion of said annular support member.

6. The apparatus of claim 1, wherein said first and second end portions of said posterior leaflet support member is securely attached to said posterior end portion at oppositely disposed locations.

7. The apparatus of claim 1 further comprising:

at least one anterior leaflet support member securely connected to said annular support member and being dimensioned to extend across a portion of the free edge of the anterior valve leaflet, said anterior leaflet support member comprising a second arcuate center portion integrally formed with and extending between third and fourth end portions, said second arcuate center portion having a convex shape relative to said anterior end portion, each of said third and fourth end portions having a convex shape relative to said anterior end portion and being securely attached to said annular support member at oppositely disposed locations.

8. The apparatus of claim 1 further comprising:

a first posterior leaflet support member securely connected to said annular support member and being dimensioned to extend across a portion of the free edge of the posterior valve leaflet, said first posterior leaflet support member comprising a first arcuate center portion integrally formed with and extending between first and second end portions, said first arcuate center portion having a concave shape relative to said anterior end portion, said first and second end portions being securely connected to said first intermediate portion and said posterior end portion, respectively; and

a second posterior leaflet support member securely connected to said annular support member and being dimensioned to extend across a portion of the free edge of the posterior valve leaflet, said second posterior leaflet support member comprising a second arcuate center portion integrally formed with and extending between third and fourth end portions, said second arcuate center portion having a concave shape relative to said anterior end portion, said third and fourth end portions being securely connected to said posterior end portion and said second intermediate portion, respectively.

9. The apparatus of claim 1, wherein each of said annular support member and said posterior leaflet support member has a three-dimensional (3D) shape that corresponds to the 3D shape of the annulus and the posterior valve leaflet, respectively.

10. The apparatus of claim 9, wherein said annular support member has a saddle-shaped configuration and includes a longitudinal axis, a portion of said posterior leaflet support member extending below said longitudinal axis.

11. An apparatus for treating regurgitation of blood flow through a diseased heart valve, the diseased heart valve including an annulus, an anterior valve leaflet, and a posterior valve leaflet, each of the anterior and posterior valve leaflets having a free edge, said apparatus comprising:

an annular support member having an anterior end portion, a posterior end portion, and oppositely disposed first and second intermediate portions extending between said anterior and posterior end portions, said annular support member being dimensioned for attachment to the annulus of the heart valve;

at least one posterior leaflet support member securely connected to said annular support member and being dimensioned to extend across a portion of the free edge of the posterior valve leaflet, said posterior leaflet support member comprising a first arcuate center portion integrally formed with and extending between first and second end portions, said first arcuate center portion having a concave shape relative to said anterior end portion, each of said first and second end portions having a convex shape relative to said anterior end portion and being securely attached to said posterior end portion at oppositely disposed locations; and

at least one anterior leaflet support member securely connected to said annular support member and being dimensioned to extend across a portion of the free edge of the anterior valve leaflet, said anterior leaflet support member comprising a second arcuate center portion integrally formed with and extending between third and fourth end portions, said second arcuate center portion having a convex shape relative to said anterior end portion, each of said third and fourth end portions having a concave shape relative to said anterior end portion and being securely attached to said first and second intermediate portions, respectively.

12. The apparatus of claim 11, wherein each of said annular support member, said anterior leaflet support member, and said posterior leaflet support member has a 3D shape that corresponds to the 3D shape of the annulus, the anterior valve leaflet, and the posterior valve leaflet, respectively.

13. The apparatus of claim 12, wherein said annular support member has a saddle-shaped configuration and includes a longitudinal axis, a portion of each of said posterior and anterior leaflet support members extending below said longitudinal axis.

14. An apparatus for treating regurgitation of blood flow through a diseased heart valve, the diseased heart valve including an annulus, an anterior valve leaflet, and a posterior valve leaflet, each of the anterior and posterior valve leaflets having a free edge, said apparatus comprising:

an annular support member having an anterior end portion, a posterior end portion, and oppositely disposed first and second intermediate portions extending between said anterior and posterior end portions, said annular support member being dimensioned for attachment to the annulus of the heart valve;

at least one posterior leaflet support member securely connected to said annular support member and being dimensioned to extend across a portion of the free edge of the posterior valve leaflet, said posterior leaflet support member comprising a first arcuate center portion integrally formed with and extending between first and second end portions, said first arcuate center portion having a convex shape relative to said anterior end portion, each of said first and second end portions being securely attached to said posterior end portion at oppositely disposed locations; and

at least one anterior leaflet support member securely connected to said annular support member and being dimensioned to extend across a portion of the free edge of the anterior valve leaflet, said anterior leaflet support member comprising a second arcuate center portion integrally formed with and extending between third and fourth end portions, said second arcuate center portion having a convex shape relative to said anterior end portion, each of said third and fourth end portions being securely attached to oppositely disposed locations about said annular support member.

15. The apparatus of claim 14, wherein each of said third and fourth end portions have a concave shape relative to said anterior end portion of said annular support member.

16. The apparatus of claim 14, wherein each of said third and fourth end portions are securely connected to said first and second intermediate portions of said annular support member, respectively.

17. The apparatus of claim 14, wherein each of said third and fourth end portions has a convex shape relative to said first and second intermediate portions, respectively.

18. The apparatus of claim 14, wherein each of said first and second end portions has a concave shape relative to said anterior end portion of said annular support member.

19. The apparatus of claim 14, wherein each of said first and second end portions is substantially perpendicular to said anterior end portion of said annular support member.

20. The apparatus of claim 14, wherein each of said annular support member, said anterior leaflet support member, and said posterior leaflet support member has a 3D shape that corresponds to the 3D shape of the annulus, the anterior valve leaflet, and the posterior valve leaflet, respectively.

21. The apparatus of claim 20, wherein said annular support member has a saddle-shaped configuration and includes a longitudinal axis, a portion of each of said posterior and anterior leaflet support members extending below said longitudinal axis.

22. An apparatus for treating regurgitation of blood flow through a diseased heart valve, the diseased heart valve including an annulus, an anterior valve leaflet, and a posterior valve leaflet, each of the anterior and posterior valve leaflets having a free edge, said apparatus comprising:

an annular support member having an anterior end portion, a posterior end portion, and oppositely disposed first and second intermediate portions extending between said anterior and posterior end portions, said annular support member being dimensioned for attachment to the annulus of the heart valve;

at least one posterior leaflet support member securely connected to said annular support member and being dimensioned to extend across a portion of the free edge of the posterior valve leaflet, said posterior leaflet support member comprising a first arcuate center portion integrally formed with and extending between first and second end portions, said first arcuate center portion having a concave shape relative to said anterior end portion, each of said first and second end portions being securely attached to said annular support member at oppositely disposed locations; and

at least one anterior leaflet support member securely connected to said annular support member and being dimensioned to extend across a portion of the free edge of the anterior valve leaflet, said anterior leaflet support member comprising a second arcuate center portion integrally formed with and extending between third and fourth end portions, said second arcuate center portion having a convex shape relative to said anterior end portion, each of said third and fourth end portions being securely attached to said annular support member at oppositely disposed locations;

said first and second arcuate center portions being joined together to form a common junction, said common junction supporting a portion of each of the free edges of the anterior and posterior valve leaflets.

23. The apparatus of claim 22, wherein said first and second end portions are securely connected to said posterior end portion and said third and fourth end portions are securely connected to said anterior end portion.

24. The apparatus of claim 22, wherein said first and third end portions are securely connected to said first intermediate portion and said second and fourth end portions are securely connected to said second intermediate portion.

25. The apparatus of claim 22, wherein each of said annular support member and said common junction has a 3D shape that corresponds to the 3D shape of the annulus and a portion of each of the free edges of the anterior and posterior valve leaflets, respectively.

26. The apparatus of claim 25, wherein a portion of said common junction extends below said longitudinal axis.

27. A sizing device comprising:

a handle member including a handle fluidly connected to a distal attachment portion; and

a sizing member securely attached to said distal attachment portion, said sizing member defining a longitudinal axis and including an annular member having an anterior end portion, a posterior end portion, and first and second intermediate portions extending between said anterior and posterior end portions, said sizing member further including a bracing portion that extends between said first and second intermediate portions and a leaflet support member connected thereto, said leaflet support member extending below said longitudinal axis.

28. The sizing device of claim 27, wherein said bracing portion extends above said longitudinal axis.

29. The sizing device of claim 27, wherein said bracing portion includes an attachment mechanism for attaching said distal attachment portion to said annular member.

30. The sizing device of claim 27, wherein said annular member has a linear configuration relative to said longitudinal axis.

31. The sizing device of claim 27, wherein said annular member has a saddle-shaped configuration relative to said longitudinal axis.

32. A method for treating regurgitation of blood flow through a diseased heart valve, the diseased heart valve including an annulus, an anterior valve leaflet, and a posterior valve leaflet, each of the anterior and posterior valve leaflets having a free edge, said method comprising the steps of:

providing an apparatus comprising an annular support member and at least one leaflet support member securely connected to the annular support member, the annular support member comprising an anterior end portion, a posterior end portion, and oppositely disposed first and second intermediate portions extending between the anterior and posterior end portions, the at least one leaflet support member comprising a first end portion, a second end portion, and an arcuate center portion extending between the first and second end portions, the arcuate center portion having a convex shape relative to the anterior end portion; and

attaching the annular support member to the annulus of the diseased heart valve so that at least one free edge of the anterior and posterior valve leaflets coapts with a portion of the at least one leaflet support member to prevent or substantially reduce regurgitation of blood flow through the diseased heart valve.

33. The method of claim 32, wherein said step of attaching the annular support member to the annulus of the diseased heart valve further comprises:

providing a sizing device comprising a handle member fluidly connected to a distal attachment portion, the sizing member including an annular member defining a longitudinal axis and having an anterior end portion, a posterior end portion, and first and second intermediate portions extending between the anterior and posterior end portions, the sizing member further including a bracing portion extending between the first and second intermediate portions and a leaflet support member connected thereto, the leaflet support member extending below the longitudinal axis;

placing the sizing member in the left ventricle so that the annular member contacts the annulus of the diseased valve; and

measuring blood flow through the diseased heart valve to determine the optimal dimensions for the apparatus;

wherein normal blood flow through the diseased heart valve indicates the optimal dimensions of the apparatus.

34. The method of claim 33 further comprising the steps of:

attaching the optimally-sized apparatus to a delivery device;

positioning the delivery device about the annulus of the diseased heart valve; and

deploying the apparatus.