APPARATUS AND METHOD FOR TREATING A REGURGITANT HEART VALVE

• US 20120179247A1
• Filed: 01/04/2012
• Published: 07/12/2012
• Est. Priority Date: 11/19/2007
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Navia, Jose L.
• Granted Patent: US 8,784,483 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• 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 apparatus, 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 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 at least one subvalvular structure.

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, wherein the at least one subvalvular structure comprises at least a portion of an inferior free edge of the posterior or anterior valve leaflets, a portion of a chordae tendineae associated with the posterior or anterior valve leaflets, or a portion of a papillary muscle associated with the posterior or anterior valve leaflets.

13. 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 apparatus, 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;

a first infra-annular support member securely connected to said substantially annular support member at a first location; and

a second infra-annular support member securely connected to said substantially annular support member at a second location;

wherein said first and second infra-annular support members are dimensioned to extend below at least one of the posterior and anterior valve leaflets and across or behind at least one subvalvular structure.

14. The apparatus of claim 13, wherein said first and second locations are oppositely disposed from one another.

15. The apparatus of claim 13, wherein a portion of said first infra-annular support member overlaps with, and is axially offset from, a portion of said second infra-annular support member.

16. The apparatus of claim 13, wherein the at least one subvalvular structure comprises at least a portion of an inferior free edge of the posterior or anterior valve leaflets, a portion of a chordae tendineae associated with the posterior or anterior valve leaflets, or a portion of a papillary muscle associated with the posterior or anterior valve leaflets.

17. 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 apparatus, said method comprising the steps of:

providing an apparatus comprising a substantially annular support member and at least one infra-annular support member securely connected thereto, 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; 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 at least one subvalvular structure to prevent or substantially reduce regurgitation of blood flow through the diseased heart valve.

18. The method of claim 17, wherein said step of attaching the substantially annular support member to the annulus of the diseased heart valve further comprises:

providing a sizing device comprising a handle member 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 a heart ventricle associated with the disease heart valve so that the annular member contacts the annulus of the diseased heart valve; and

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

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

19. The method of claim 18 further comprising the steps of:

attaching the optimally-sized apparatus to a delivery device or holder;

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

deploying the apparatus.

20. The method of claim 17, 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.

21. The method of claim 20, 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.

22. The method of claim 20, 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.