Device and method for treatment of heart valve regurgitation

• US 8,460,370 B2
• Filed: 04/15/2010
• Issued: 06/11/2013
• 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, Alon, David, Michaly, David
• Primary Examiner(s): Isabella, David
• Application Number:
  US12/761,225
• Publication Number:
  US 20100198347A1
• Time in Patent Office: 1,153 Days
• Field of Search: 623/1.24, 623/2.1, 623/2.11, 623/2.12, 623/2.14, 623/2.36, 623/2.37
• US Class Current: 623/2.12
• 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
• 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 a coaptation portion, the coaptation portion having a radial cross section with a long axis and a short axis, a length of the long axis substantially longer than a width of the short axis, the coaptation portion comprising a support structure;

advancing the delivery catheter into a heart;

deploying the coaptation portion between leaflets of a mitral valve and at least a portion thereof within a mitral valve annulus, with the long axis of the radial cross section of the coaptation portion substantially aligned with a length between commissures of the mitral valve and the support structure pressing against the commissures;

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

allowing backpressure from blood in a left ventricle to move the leaflets of the mitral valve to a closed position during systole,

wherein the coaptation portion is configured to block gaps between the leaflets of the mitral valve when the leaflets are in the closed position for reducing regurgitation through the mitral valve during systole, and

wherein the coaptation portion comprises an expandable pocket member, the expandable pocket member having a length along the long axis of the coaptation portion and a width along the short axis of the coaptation portion, during systole, the expandable pocket member expanding along the width thereof and substantially not expanding along the length thereof, and during diastole, the expandable pocket member contracts, with an open lower end of the pocket expanding and contracting during systole and diastole.

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 conforming to the opening in the mitral valve.

3. The method of claim 2, wherein the expandable pocket member comprises pericardial tissue.

4. The method of claim 3, wherein the prosthesis further comprises a support structure constructed to provide the expandable pocket member with a cross-sectional profile in which the width of the expandable pocket member is substantially smaller than the length of the expandable pocket member.

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 penetrates tissue along the septal wall of the heart.

7. The method of claim 6, wherein the anchoring portion further comprises at least one positioning arm for pressing against the septal wall.

8. The method of claim 6, wherein the anchoring portion further comprises at least two positioning arms for pressing against opposing sides of the septal wall.

14. The method of claim 1, wherein securing the anchoring portion to the septal wall of the heart comprises securing the anchoring portion to an atrial septal wall of the heart.

15. The method of claim 1, wherein loading the prosthesis within the delivery catheter comprises loading the prosthesis within the delivery catheter, the prosthesis including an anchoring portion comprising a positioning arm, the positioning arm comprising a first end coupled to the coaptation portion and a second end comprising a base anchorable to the septal wall of the heart.

9. 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, the anchoring portion comprising a positioning arm, the positioning arm comprising a first end coupled to the coaptation portion and a second end comprising a base anchorable to a septal wall of a heart;

advancing the delivery catheter into the heart;

deploying the coaptation portion between leaflets of a mitral valve and through an annulus thereof, a long axis of a radial cross section of the coaptation portion substantially aligned between commissures of the mitral valve, the long axis substantially longer than a short axis of the radial cross section of the coaptation portion; and

securing the base of the anchoring portion to the 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 when the leaflets are closed for reducing regurgitation through the mitral valve during systole, and to permit blood flow therearound during diastole, and

wherein the coaptation portion comprises an expandable pocket member, the expandable pocket member having a length along the long axis of the coaptation portion and a width along the short axis of the coaptation portion, during systole, the expandable pocket member expanding along the width thereof and substantially not expanding along the length thereof, and during diastole, the expandable pocket member contracts, with an open lower end of the pocket expanding and contracting during systole and diastole.

10. The method of claim 9, 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.

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 9, wherein the anchoring portion penetrates tissue along the septal wall of the heart.

13. The method of claim 9, wherein the anchoring portion further comprises at least one positioning arm for pressing against the septal wall.

16. The method of claim 9, wherein securing the base of the anchoring portion to the septal wall of the heart comprises securing the base of the anchoring portion to an atrial septal wall of the heart.

17. The method of claim 9, wherein the base anchorable to a septal wall of a heart comprises a plurality of septum attachment arms.