DEVICE AND METHOD FOR TREATMENT OF HEART VALVE REGURGITATION

• US 20100198347A1
• Filed: 04/15/2010
• Published: 08/05/2010
• Est. Priority Date: 09/14/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Zakay, Avraham, Rottenberg, Dan, Mishaly, David, Alon, David
• Granted Patent: US 8,460,370 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2210/0066 shrinkable

Abstract

In one embodiment, the present invention provides a prosthesis that can be implanted within a heart to at least partially block gaps that may be present between the two mitral valve leaflets. In one preferred embodiment, the prosthesis includes an anchoring ring that expands within the left atrium to anchor the prosthesis and a pocket member fixed to the anchoring ring. The pocket member is positioned within the mitral valve, between the leaflets so that an open end of the pocket member is positioned within the left ventricle. When the mitral valve is open, blood flows past the pocket member, maintaining the pocket member in a collapsed state. When the mitral valve closes, the backpressure of the blood pushes into the pocket member, expanding the pocket member to an inflated shape. The mitral valve leaflets contact the expanded pocket member, allowing the prosthesis to block at least a portion of the openings between the leaflets, thereby minimizing regurgitated blood flow into the left atrium.

Claims

1. A method of treating mitral valve regurgitation, comprising:

loading a prosthesis within a delivery catheter, the prosthesis including an anchoring portion and an expandable pocket member having an elongated cross-sectional profile;

advancing the delivery catheter into a heart;

deploying the expandable pocket member between leaflets of a mitral valve; and

expanding the anchoring portion to engage a wall of the heart, the expandable pocket member being supported by the anchoring portion for maintaining the expandable pocket member between the leaflets of the mitral valve;

wherein the expandable pocket member is configured to expand during systole for blocking gaps between the leaflets of the mitral valve, thereby reducing regurgitation through the mitral valve.

2. The method of claim 1, wherein a width of the expandable pocket member is substantially smaller than a length of the expandable pocket member for conforming to the opening in the mitral valve.

3. The method of claim 1, wherein the expandable pocket member comprises pericardial tissue.

4. The method of claim 1, wherein the prosthesis further comprises a support structure constructed to provide the expandable pocket member with the elongated cross-sectional profile.

5. The method of claim 4, wherein the support structure is made of a shape memory material.

6. The method of claim 1, wherein the anchoring portion is configured to engage a left atrial chamber of the heart.

7. A method of treating mitral valve regurgitation, comprising:

loading a prosthesis within a delivery catheter, the prosthesis including an anchoring portion and a coaptation portion;

advancing the delivery catheter into a heart;

deploying the coaptation portion between leaflets of a mitral valve; and

securing the anchoring portion to a septal wall of the heart, the coaptation portion being supported by the anchoring portion for maintaining the coaptation portion between the leaflets of the mitral valve;

wherein the coaptation portion is configured to block gaps between the leaflets of the mitral valve for reducing regurgitation through the mitral valve during systole.

8. The method of claim 7, wherein the coaptation portion comprises an expandable pocket member.

9. The method of claim 8, wherein a width of the expandable pocket member is substantially smaller than a length of the expandable pocket member for conforming to the opening in the mitral valve.

10. The method of claim 9, wherein the expandable pocket member comprises pericardial tissue.

11. The method of claim 10, wherein the prosthesis further comprises a support structure constructed to provide the expandable pocket member with the elongated cross-sectional profile.

12. The method of claim 11, wherein the support structure is made of a shape memory material.

13. The method of claim 7, wherein the anchoring portion penetrates tissue along the septal wall of the heart.

14. The method of claim 13, wherein the anchoring portion further comprises at least one positioning arm for pressing against the septal wall.

15. The method of claim 13, wherein the anchoring portion further comprises at least two positioning arms for pressing against opposing sides of the septal wall.