Apparatus and method for treating a regurgitant heart valve

• US 8,216,303 B2
• Filed: 11/19/2008
• Issued: 07/10/2012
• Est. Priority Date: 11/19/2007
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Navia, Jose Luis
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US12/274,087
• Publication Number:
  US 20090132036A1
• Time in Patent Office: 1,329 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.14, 623/2.18, 623/1.34, 623/1.36, 623 236- 238, 606/151
• US Class Current: 623/2.36
• 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 anterior end portion and said posterior end portion of said annular support member being dimensioned for attachment to anterior and posterior portions of the annulus of the heart valve, respectively, said posterior end portion and said first and second intermediate portions forming a continuous arc so that said posterior end portion has a convex shape relative to said anterior end portion; and

at least one arc-shaped 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 center portion integrally formed with and extending between first and second end portions, said first end portion, said second end portion, and said center portion forming a continuous arc so that said posterior leaflet support member has 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;

wherein said annular support member has a saddle-shaped configuration and at least a portion of said posterior leaflet support member extends beyond said annular support member so that said at least a portion of said posterior leaflet support member is positioned below the annulus of the diseased heart valve when said apparatus is implanted thereon.

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 1, wherein said posterior leaflet support member includes an adjustment mechanism for selectively adjusting the position of said posterior leaflet support member relative to said annular support member.

11. The apparatus of claim 1, wherein said posterior leaflet support member has a semi-rigid configuration so that said posterior leaflet support member is bendable to various positions relative to said annular support member.

12. 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 consisting of:

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, said posterior end portion and said first and second intermediate portions forming a continuous arc so that said posterior end portion has a convex shape relative to said anterior end portion; and

at least one arc-shaped 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 first end portion, said second end portion, and said arcuate center portion forming a continuous arc so that said posterior leaflet support member has 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.

13. An apparatus for treating regurgitation of blood flow through a diseased mitral valve, the diseased mitral valve including a D-shaped annulus, an anterior mitral leaflet, and a posterior mitral leaflet, each of the anterior and posterior mitral 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 having a D-shaped configuration that corresponds to the D-shaped mitral valve annulus, said anterior and posterior end portions of said annular support member being dimensioned for attachment to the anterior and posterior portions of the mitral annulus, respectively, said posterior end portion and said first and second intermediate portions forming a continuous arc so that said posterior end portion has a convex shape relative to said anterior end portion; and

at least one arc-shaped 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 mitral leaflet;

said posterior leaflet support member comprising a center portion integrally formed with and extending between first and second end portions, said first end portion, said second end portion, and said center portion forming a continuous arc so that said posterior leaflet support member has 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;

wherein said annular support member has a saddle-shaped configuration and at least a portion of said posterior leaflet support member extends beyond said annular support member so that said at least a portion of said posterior leaflet support member is positioned below the annulus of the diseased heart valve when said apparatus is implanted thereon.

14. The apparatus of claim 13, wherein said at least one posterior leaflet support member is dimensioned to extend across only a portion of the free edge of the posterior mitral leaflet.