Coiled anchor for supporting prosthetic heart valve, prosthetic heart valve, and deployment device

• US 10,052,198 B2
• Filed: 02/20/2015
• Issued: 08/21/2018
• 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., Spence, Paul A., Tompkins, Landon H.
• Primary Examiner(s): Dang, Son
• Application Number:
  US14/628,020
• Publication Number:
  US 20150230921A1
• Time in Patent Office: 1,278 Days
• 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 system for implanting a mitral valve prosthesis in a native mitral valve of a heart comprising:

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

a mitral valve prosthesis for docking within the coiled anchor, the mitral valve prosthesis comprising an expandable frame and a plurality of leaflets for controlling blood flow through the mitral valve prosthesis, wherein the frame is expandable from a collapsed first configuration in which the frame has a first outer diameter for delivery of the mitral valve prosthesis through a catheter to an expanded second configuration in which the frame has a second outer diameter greater than the first outer diameter;

wherein the frame of the mitral valve prosthesis has a first frame end and a second frame end, and the mitral valve prosthesis further comprises a protective annular ring that includes two different materials and surrounds a bottom edge of the second frame end.

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

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

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

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

6. The system of claim 1, 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.

7. The system of claim 6, wherein a frictional force is generated 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.

8. The system of claim 6, wherein a portion of the frame that is not in contact with a portion of the coiled anchor having a 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.

9. The system of claim 1, wherein the protective layer comprises at least one of a foam layer or a fabric layer.

10. The system of claim 1, 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.

11. A system for implanting a mitral valve prosthesis in a native mitral valve of a heart comprising:

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

a mitral valve prosthesis for docking within the coiled anchor, the mitral valve prosthesis comprising an expandable frame and a plurality of leaflets for controlling blood flow through the mitral valve prosthesis, wherein the frame is expandable from a collapsed first configuration in which the frame has a first outer diameter for delivery of the mitral valve prosthesis through a catheter to an expanded second configuration in which the frame has a second outer diameter greater than the first outer diameter;

wherein the frame of the mitral valve prosthesis includes bottom end corners, and the mitral valve prosthesis further comprises a protective cuff that comprises two layers and surrounds the bottom end corners of the frame.

12. The system of claim 11, wherein the cover layer comprises a fabric layer.

13. The system of claim 11, wherein the cover layer comprises a foam layer.

14. The system of claim 11, wherein the cover layer comprises a fabric layer surrounding a foam layer.

15. The system of claim 11, wherein a frictional force is generated to restrict circumferential motion of the coiled anchor, such that circumferential unwinding of the coiled anchor is restricted.

16. The system of claim 11, wherein the protective layer comprises an annular ring extending around the second frame end.