Apparatus and method for treating a regurgitant heart valve

• US 8,784,483 B2
• Filed: 01/04/2012
• Issued: 07/22/2014
• Est. Priority Date: 11/19/2007
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Navia, Jose L.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US13/343,480
• Publication Number:
  US 20120179247A1
• Time in Patent Office: 930 Days
• Field of Search: 623/2.36, 623/2.37, 623/2.38, 623/2.39, 623/2.18, 623/1.24, 623/1.26, 623/2.11, 623/2.14
• 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 2/2466 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
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

Abstract

An apparatus is provided for treating regurgitation of blood flow through a diseased heart valve. The diseased heart valve includes an annulus, anterior and posterior valve leaflets, and a subvalvular apparatus. The apparatus includes a substantially annular support member and at least one infra-annular support member securely connected thereto. The substantially annular support member has at least a first intermediate portion, a second intermediate portion, and a posterior end portion extending between the first and second intermediate portions. The posterior end portion is dimensioned for attachment to a posterior portion of the annulus of the diseased heart valve. The at least one infra-annular support member is securely connected to the substantially annular support member at a first location. The at least one infra-annular support member is dimensioned to extend below at least one of the posterior and anterior valve leaflets and across or behind at least one subvalvular structure.

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, a posterior valve leaflet and a subvalvular structure, said apparatus comprising:

a substantially annular support member having at least a first intermediate portion, a second intermediate portion, and a posterior end portion extending between said first and second intermediate portions, said posterior end portion being dimensioned for attachment to a posterior portion of the annulus of the diseased heart valve; and

at least one infra-annular support member having a free end and being securely connected to said substantially annular support member at a first location, said at least one infra-annular support member being dimensioned to extend below at least one of the posterior and anterior valve leaflets and across or behind the at least one subvalvular structure wherein the at least one infra-annular support member have a rigid or semi-rigid configuration that can be selectively adjusted to maintains a final shape; and

wherein said infra-annular support member is sized and dimensioned to contact the inferior free edge of the posterior mitral leaflet.

2. The apparatus of claim 1, wherein said substantially annular support member has a saddle-shaped configuration that corresponds to the three-dimensional shape of the annulus.

3. The apparatus of claim 1, wherein said substantially annular support member further includes an anterior end portion that extends between said first and second intermediate portions and is oppositely disposed from said posterior end portion, said anterior end portion being dimensioned for attachment to an anterior portion of the annulus of the diseased heart valve.

4. The apparatus of claim 1, wherein said at least one infra-annular support member further comprises:

an arcuate engaging portion configured to contact the at least one subvalvular structure from behind; and

an integral neck portion extending from said engaging portion to said first location.

5. The apparatus of claim 4, wherein said engaging portion has a convex shape relative to said posterior end portion of said substantially annular support member.

6. The apparatus of claim 1, wherein said at least one infra-annular support member has a bifurcated configuration comprising spaced apart first and second engaging portions.

7. The apparatus of claim 6, wherein said first and second engaging portions are axially offset from one another.

8. The apparatus of claim 6, wherein said first and second engaging portions are radially offset from one another.

9. The apparatus of claim 1, wherein said at least one infra-annular support member has an elongated, loop-shaped configuration.

10. The apparatus of claim 1, further including a second infra-annular support member securely connected to the substantially annular support member at the first location.

11. The apparatus of claim 1, wherein said at least one infra-annular support member includes an adjustment mechanism for selectively adjusting the position of said at least one infra-annular support member relative to a longitudinal axis of said substantially annular support member.

12. The apparatus of claim 1, including only one of said infra-annular support member.

13. The apparatus of claim 1, wherein said at least one infra-annular support member extends at an angle relative to a longitudinal axis of said substantially annular support member of between about 10°

and about 60°

.

14. The apparatus of claim 1, wherein said infra-annular support member has an elongated, S-shaped configuration.

15. The apparatus of claim 1, wherein said infra-annular support member partially extends between said first and second intermediate portions.

16. The apparatus of claim 1, wherein said infra-annular support member is connected to said annular support member at a single location.

17. The apparatus of claim 1, wherein said infra-annular support member extends across less than the inferior free edge of the posterior mitral leaflet.

18. A method for treating regurgitation of blood flow through a diseased heart valve, the diseased heart valve including an annulus, an anterior valve leaflet, a posterior valve leaflet and a subvalvular structure, said method comprising the steps of:

providing an apparatus comprising a substantially annular support member and at least one infra-annular support member having a free end and being securely connected thereto at a first location, the infra-annular support member being sized and dimensioned to contact the inferior free edge of the posterior mitral leaflet, the substantially annular support member having at least a first intermediate portion, a second intermediate portion and a posterior end portion extending between the first and second intermediate portions, wherein the at least one infra-annular support member have a rigid or semi-rigid configuration that can be selectively adjusted to maintains a final shape; and

attaching the substantially annular support member to the annulus of the diseased heart valve so that the at least one infra-annular support member extends below at least one of the posterior and anterior valve leaflets and across or behind the at least one subvalvular structure to prevent or substantially reduce regurgitation of blood flow through the diseased heart valve.

19. The method of claim 18, wherein said step of attaching the substantially annular support member to the annulus of the diseased heart valve provides simultaneous annular and sub-annular levels of cardiac remodeling by a reverse remodeling mechanism.

20. The method of claim 19, wherein the reverse remodeling mechanism simultaneously corrects and normalizes the level and angle of leaflet coaptation, prevents leaflet tethering, and resolves recurrent valve regurgitation over time.

21. The method of claim 19, wherein cardiac remodeling at the annular level prevents or mitigates ventricular remodeling by displacing a posterior ventricular wall, and cardiac remodeling at the sub-annular level causes at least one of the posterior leaflet, the anterior leaflet, a chordae tendineae, or a papillary muscle to be displaced and thereby reduce the restrictive motion of the posterior or anterior leaflet during systole.

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, a posterior valve leaflet and a subvalvular structure, said apparatus comprising:

a substantially annular support member having at least a first intermediate portion, a second intermediate portion, and a posterior end portion extending between said first and second intermediate portions, said posterior end portion being dimensioned for attachment to a posterior portion of the annulus of the diseased heart valve; and

at least one infra-annular support member having a free end and being securely connected to said substantially annular support member at a first location, said at least one infra-annular support member being dimensioned to extend below at least one of the posterior and anterior valve leaflets and across or behind the at least one subvalvular structure;

wherein the at least one infra-annular support member have a rigid or semi-rigid configuration that can be selectively adjusted to maintains a final shape; and

wherein each of said annular support member and said infra-annular support member has a continuous, arc-shaped configuration.

23. The apparatus of claim 22, wherein said infra-annular support member extends across less than the entire subvalvular structure.