DEVICE AND METHOD FOR REDUCING MITRAL VALVE REGURGITATION

• US 20130268069A1
• Filed: 06/05/2013
• Published: 10/10/2013
• 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: Zakai, Avraham, Mishaly, David, Rottenberg, Dan, Alon, David
• Granted Patent: US 8,992,605 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• 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. 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 device for treating mitral valve regurgitation comprising:

a flexible pocket made of pericardium, the pocket having a rounded arch-shape with an open bottom, the pocket having an elongated cross-sectional profile, the cross-sectional profile having a width in a first radial direction and a length in a second radial direction, the width substantially smaller than the length, the elongated profile sized for placement at least partially between leaflets of a native mitral valve, the pocket convertible between an expanded configuration and a contracted configuration in response to changes in pressure, the width in the expanded configuration greater than the width in the contracted configuration, while the length is substantially constant in the expanded configuration and the contracted configuration, the pocket in the expanded configuration restricting blood flow between the leaflets and the coaptation member, and the pocket in the contracted configuration allowing blood to flow between the leaflets and the pocket;

a support framework coupled to the coaptation member, the support framework comprising a nitinol ring, the support framework providing the coaptation member with the elongated cross-sectional profile; and

an anchoring structure coupled to the support structure, the anchoring structure comprising a positioning arm and multiple septum attachment arms, the septum attachment arms disposable on either side of an atrial septum to secure a base of the positioning arm penetrating therethrough, the positioning arm sized to position the elongated profile of the coaptation member between the leaflets of the native mitral valve with the base thereof secured to the atrial septum.

2. The device of claim 1, wherein the ring is sized to press against wall of a left atrium.

3. The device of claim 1, wherein the ring is sized to anchor the device within a commissure of the mitral valve.

4. A device for treating mitral valve regurgitation comprising:

a coaptation member having an elongated cross-sectional profile, the cross-sectional profile having a width in a first radial direction and a length in a second radial direction, the width substantially smaller than the length, the elongated profile sized for placement at least partially between leaflets of a native mitral valve, the coaptation member convertible between an expanded configuration and a contracted configuration in response to changes in pressure, the width in the expanded configuration greater than the width in the contracted configuration, while the length is substantially constant in the expanded configuration and the contracted configuration, the coaptation member in the expanded configuration restricting blood flow between the leaflets and the coaptation member, and the coaptation member in the contracted configuration allowing blood to flow between the leaflets and the coaptation member;

a support structure coupled to the coaptation member, the support structure providing the coaptation member with the elongated cross-sectional profile; and

an anchoring structure coupled to the support structure, the anchoring structure comprising a positioning arm and multiple septum attachment arms, the septum attachment arms disposable on either side of an atrial septum to secure a base of the positioning arm penetrating therethrough, the positioning arm sized to position the elongated profile of the coaptation member between the leaflets of the native mitral valve with the base thereof secured to the atrial septum.

5. The device of claim 4, wherein the coaptation member includes a flexible pocket, the flexible pocket comprised of flexible material disposed on the support structure, wherein the support structure is sized to urge the flexible material along a length of a commissure of said leaflets.

6. The device of claim 5, wherein the flexible material is pericardial tissue.

7. The device of claim 5, wherein the flexible pocket has a rounded arch-shape.

8. The device of claim 4, wherein the length of cross-sectional profile of the coaptation member is substantially equal to a length of a commissure of the leaflets.

9. The device of claim 4, wherein the support structure is nitinol.

10. The device of claim 4, wherein the support structure comprises a ring.

11. The device of claim 10, wherein the ring is sized to press against wall of a left atrium.

12. The device of claim 10, wherein the ring is sized to anchor the device within a commissure of the mitral valve.