COILED ANCHOR FOR SUPPORTING PROSTHETIC HEART VALVE, PROSTHETIC HEART VALVE, AND DEPLOYMENT DEVICE

• US 20150230921A1
• Filed: 02/20/2015
• Published: 08/20/2015
• Est. Priority Date: 08/14/2013
• Status: Active Grant

• Current Assignee: Mitral Valve Technologies Sarl (Edwards Lifesciences Corporation)
• Original Assignee: Mitral Valve Technologies Sarl (Edwards Lifesciences Corporation)
• Inventors: Chau, Mark, Siegel, Alexander J.
• Granted Patent: US 10,052,198 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

A coiled anchor for docking a mitral valve prosthesis at a native mitral valve of a heart has a first end, a second end, and a central axis extending between the first and second ends, and defines an inner space coaxial with the central axis. The coiled anchor includes a coiled core including a bio-compatible metal or metal alloy and having a plurality of turns extending around the central axis in a first position, and a cover layer around the core, the cover layer including a bio-compatible material that is less rigid than the metal or metal alloy of the coiled core.

Claims

1. A coiled anchor for docking a mitral valve prosthesis at a native mitral valve of a heart and having a first end, a second end, a central axis extending between the first and second ends, and defining an inner space coaxial with the central axis, the coiled anchor comprising:

a coiled core comprising a bio-compatible metal or metal alloy and having a plurality of turns extending around the central axis in a first position; and

a cover layer around the core, the cover layer comprising a bio-compatible material that is less rigid than the metal or metal alloy of the coiled core;

wherein the coiled anchor is adjustable from the first position to a second position wherein at least one of the plurality of turns is straightened for the coiled anchor to be delivered through a catheter to the native mitral valve, and from the second position back to the first position; and

wherein the coiled anchor is implantable at the native mitral valve with at least a portion on one side of the native mitral valve in a left atrium of the heart and at least a portion on an opposite side of the native mitral valve in a left ventricle of the heart, to support or hold the mitral valve prosthesis in the inner space when the coiled anchor is implanted at the native mitral valve.

2. The coiled anchor of claim 1, wherein the cover layer comprises a fabric layer.

3. The coiled anchor of claim 1, wherein the cover layer comprises a foam layer.

4. The coiled anchor of claim 1, wherein the cover layer comprises a fabric layer surrounding a foam layer.

5. The coiled anchor of claim 1, wherein the coiled core comprises a shape memory material.

6. A system for implanting at a mitral valve comprising:

the coiled anchor of claim 1; and

a mitral valve prosthesis comprising an expandable frame and housing a plurality of leaflets for controlling blood flow therethrough, wherein the frame is expandable from a collapsed first position wherein the frame has a first outer diameter for delivery of the mitral valve prosthesis through a catheter to an expanded second position wherein the frame has a second outer diameter greater than the first outer diameter;

wherein when the coiled anchor and the mitral valve prosthesis are unbiased, a smallest inner diameter of the inner space defined by the coil anchor is smaller than the second outer diameter of the mitral valve prosthesis.

7. The mitral valve implant of claim 6, wherein when the mitral valve prosthesis is held in the inner space of the coiled anchor, respective portions of the coiled anchor and the frame in contact with one another are restricted from expanding to the second outer diameter.

8. The mitral valve implant of claim 7, wherein a frictional force is generated between the contact between the cover layer of the coiled anchor and the frame of the mitral valve prosthesis, to restrict circumferential motion between the coiled anchor and the mitral valve prosthesis, such that circumferential unwinding of the coiled anchor and radial expansion of the inner space of the coiled anchor is restricted.

9. The mitral valve implant of claim 7, wherein a portion of the frame that is not in contact with the portion of the coiled anchor having the smallest inner diameter is configured to expand radially outwardly to a diameter that is greater than the smallest inner diameter of the coiled anchor and smaller than the second outer diameter of the frame of the mitral valve prosthesis.

10. The mitral valve implant of claim 7, wherein the frame of the mitral valve prosthesis has a first end and a second end, and further comprises a protective layer covering at least a portion of the second end of the mitral valve prosthesis that is positioned farthest away from the first end of the mitral valve prosthesis.

11. The mitral valve implant of claim 10, wherein the protective layer comprises an annular ring extending around the second end of the frame of the mitral valve prosthesis.

12. The mitral valve implant of claim 10, wherein the protective layer comprises at least one of a foam layer or a fabric layer.

13. A coiled anchor for docking a mitral valve prosthesis at a native mitral valve of a heart and having a first end, a second end, a central axis extending between the first and second ends, and defining an inner space coaxial with the central axis, the coiled anchor comprising:

a first coil having a plurality of turns in a first circumferential direction and extending from a first end to a second end;

a second coil having a plurality of turns in a second circumferential direction opposite to the first circumferential direction and extending from a first end to a second end; and

a joint configured to hold the first end of the first coil and the first end of the second coil together, such that the first and second coils each extends away from the joint and from one another along the central axis;

wherein the coiled anchor has a first position wherein the respective turns of the first coil and the second coil each extends around the central axis; and

wherein the coiled anchor is adjustable from the first position to a second position wherein at least one of the plurality of turns of the first coil or the second coil is straightened for the coiled anchor to be delivered through a catheter to the native mitral valve, and from the second position back to the first position; and

wherein the coiled anchor is implantable at the native mitral valve with at least a portion of the first coil on one side of the native mitral valve in a left atrium of the heart, and at least a portion of the second coil on an opposite side of the native mitral valve in a left ventricle of the heart, to support or hold the mitral valve prosthesis in the inner space when the coiled anchor is implanted at the native mitral valve.

14. The coiled anchor of claim 13, wherein when the coiled anchor is delivered through the catheter to the native mitral valve, the respective second ends of the first and second coils are positioned distally in the catheter to be delivered first to the native mitral valve, and the joint is positioned proximally in the catheter.

15. The coiled anchor of claim 13, wherein the second coil is longer than the first coil.

16. The coiled anchor of claim 13, further comprising a cover layer comprising a bio-compatible material.

17. A method for delivering a coiled anchor that is configured to dock a mitral valve prosthesis at a native mitral valve of a heart, the method comprising:

positioning a catheter for delivery of the coiled anchor at the native mitral valve;

positioning a loop around chordae tendineae;

closing the loop to draw the chordae tendineae together;

advancing the coiled anchor out of the catheter and around the chordae tendineae; and

removing the loop and the catheter.

18. The method of claim 17, wherein the coil anchor defines a smallest inner diameter, and wherein the chordae tendineae are drawn together to form a smallest outer diameter that is smaller than the smallest inner diameter of the coil anchor.

19. The method of claim 17, wherein the positioning of the loop is performed using a grasping tool.

20. The method of claim 17, wherein the loop is pre-formed to have a curvature such that the loop surrounds the chordae tendineae as it is deployed.