Device and method for treatment of heart valve regurgitation

• US 7,704,277 B2
• Filed: 09/14/2005
• Issued: 04/27/2010
• 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, Mishaly, David, Alon, David, Rottenberg, Dan
• Primary Examiner(s): Sweet; Thomas J
• Assistant Examiner(s): Sharma; Yashita
• Application Number:
  US11/227,642
• Publication Number:
  US 20060058871A1
• Time in Patent Office: 1,686 Days
• Field of Search: 623/2.1, 623/2.11, 623/2.12, 623/2.14, 623/2.36, 623/2.37, 623/1.24
• 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 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 device for treating mitral valve regurgitation comprising:

a coaptation member having an elongated cross-sectional profile wherein a width in a first radial direction is substantially smaller than a length in a second radial direction, the elongated shape sized for placement at least partially between leaflets of a native mitral valve, said coaptation member adapted for expansion in said first radial direction for increasing said width while said length remains substantially constant and wherein said expansion of said coaptation member in said first radial direction restricts blood flow between said leaflets and said coaptation member and wherein a contraction of said coaptation member in said first radial direction allows blood to flow between said leaflets and said coaptation member;

a support structure coupled to said coaptation member, the support structure constructed to provide said coaptation member with said elongated cross-sectional profile, and

an anchoring structure comprising an anchoring wire that comprises a plurality of loops formed of a shape memory material, said anchoring structure connected to said coaptation member, said anchoring structure having a compressed state sized to fit within a delivery catheter and an expanded state sized to conform to a left atrium for fixation along an inner wall of the left atrium.

2. The device of claim 1, wherein said coaptation member includes a flexible pocket, said flexible pocket comprised of flexible material disposed on a support structure wherein said support structure is sized to urge said flexible material along a length of a commissure of said leaflets.

3. The device of claim 2 wherein said flexible material is pericardial tissue.

4. The device of claim 1, wherein said anchoring wire is shaped to contact a mitral valve annulus.

5. The device of claim 1, wherein said anchoring structure is constructed to expand and contract with movement of the left atrium after deployment in the heart.

6. The device of claim 1, wherein said anchoring structure includes a wire having a plurality of curved portions.

7. The device of claim 1, wherein said anchoring structure includes an anchoring cage.

8. The device of claim 1, wherein said coaptation member has a length substantially equal to a commissure of said leaflets.

9. The device of claim 1, wherein said anchoring structure is configured to engage at least an upper portion of the left atrium.

10. The device of claim 1, wherein said anchoring structure is adapted to be fixed to the inner wall of the left atrium without penetrating the inner wall.

11. The device of claim 1, wherein said coaptation member has a length that is substantially fixed and a width that increases when said coaptation member expands and decreases when said coaptation member contracts.

12. The device claim 11, wherein said length of said coaptation member is substantially equal to a commissure of said leaflets.