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

• US 10,588,742 B2
• Filed: 03/06/2018
• Issued: 03/17/2020
• 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, Phong Son H
• Application Number:
  US15/912,971
• Publication Number:
  US 20180193139A1
• Time in Patent Office: 742 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 system including an anchor for docking a prosthetic valve at a native valve of a heart can have 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 valve prosthesis can include a protective layer or annular ring that surrounds a bottom edge of the second frame end. The protective layer or annular ring can include two layers, and the two layers can be different materials.

Claims

1. A system for replacing a native valve of a heart comprising:

an anchor having a first end, a second end, a coiled region, a central axis extending through a middle of the coiled region, and defining an inner space coaxial with the central axis, the anchor comprising;

a core comprising a bio-compatible material; and

a cover layer around the core;

wherein the 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 a portion of the coiled region is straightened such that the anchor can be delivered through a catheter to the native valve; and

wherein the anchor is implantable with at least one turn of the coiled region positioned radially around native leaflets and/or chordae tendieae of the native valve; and

a prosthetic valve for docking within the anchor, the prosthetic valve comprising an expandable frame and a plurality of leaflets for controlling blood flow through the prosthetic valve, wherein the frame is expandable from a collapsed first configuration in which the frame has a first outer diameter for delivery of the prosthetic valve 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 prosthetic valve has a first frame end and a second frame end, and the prosthetic valve 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 fabric layer surrounding a foam layer.

4. The system of claim 1, wherein when the prosthetic valve is held in the inner space of the anchor, at least a portion of the frame within the inner space is restricted from fully expanding due to forces from the anchor.

5. The system of claim 4, wherein the system is configured such that, when the prosthetic valve is held in the inner space of the anchor, a frictional force is generated to restrict circumferential motion between the anchor and the prosthetic valve, such that circumferential unwinding of the anchor and radial expansion of the inner space of the anchor is restricted.

6. The system of claim 4, wherein another portion of the frame is configured to expand radially outwardly to a diameter that is greater than a diameter of the portion of the frame within the inner space that is restricted from fully expanding due to forces from the anchor.

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

8. The system of claim 1, wherein when the anchor and the prosthetic valve are unbiased, a smallest inner diameter of the inner space defined by the anchor is smaller than the second outer diameter of the prosthetic valve.

9. A system for treating a native valve of a heart comprising:

an anchor having a first end, a second end, and a coiled region defining an inner space, wherein the anchor is adjustable between a first configuration to a second configuration, wherein, in the second configuration, the coiled region is straightened enough to allow the anchor to be elongated and delivered through a catheter to the native valve, and wherein the anchor is implantable at the native valve with at least one turn of the coiled region is positioned around native leavlets and/or chordae tendineae of the native valve; and

a prosthetic valve for docking within the anchor, the prosthetic valve comprising an expandable frame and a plurality of leaflets for controlling blood flow through the prosthetic valve, wherein the frame is expandable from a collapsed first configuration in which the frame has a first outer diameter for delivery of the prosthetic valve 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 prosthetic valve includes bottom end corners, and the prosthetic valve further comprises a protective cuff that comprises two layers and surrounds the bottom end corners of the frame.

10. The system of claim 9, wherein the anchor includes a core and a cover over the core, and wherein the cover comprises a fabric layer.

11. The system of claim 9, wherein the anchor includes a core and a cover over the core, and wherein the cover comprises a fabric layer surrounding a foam layer.

12. The system of claim 9, wherein the anchor is configured to generate a frictional force such that circumferential unwinding of the anchor is restricted.

13. The system of claim 9, wherein the protective cuff comprises an annular ring extending around an outflow end of the frame.

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

15. The system of claim 9, wherein the protective cuff comprises a first fabric layer surrounding a second layer of a different material from the first fabric layer.

16. A system for implanting at a native valve comprising:

an anchor for docking a prosthetic valve at a native valve of a heart and having a first end, a second end, and a coiled region defining an inner space, the anchor comprising;

a core comprising a bio-compatible metal or metal alloy; and

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

wherein the anchor is adjustable from a first coiled configuration to a second elongated configuration wherein the coiled region is straightened such that the anchor can be passed through a catheter in the second straightened configuration to the native valve; and

wherein the anchor is implantable at the native valve with at least a portion on one side of the native valve in an atrium of the heart and at least a portion including multiple turns on an opposite side of the native valve in a ventricle of the heart surrounding native leaflets and/or chordae tendineae of the native valve; and

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

wherein, when the anchor and the prosthetic valve are unbiased, a smallest inner diameter of the inner space defined by the coil anchor is smaller than the second outer diameter of the prosthetic;

wherein the prosthetic valve further comprises a protective annular ring comprising two layers, the protective annular ring covering a bottom outflow edge of the frame.

17. The system of claim 16, wherein, when the prosthetic valve is held in the inner space of the anchor, a first portion of the frame is restricted from expanding to the second outer diameter by forces from the anchor.

18. The system of claim 17, wherein the system is configured such that, when the prosthetic valve is held in the inner space of the anchor, a frictional force is generated to restrict circumferential motion between the anchor and the prosthetic valve, such that circumferential unwinding of the anchor and radial expansion of the inner space of the anchor is restricted.

19. The system of claim 17, wherein, when the prosthetic valve is held in the inner space of the anchor, a second portion of the frame is configured to expand radially outwardly to a diameter that is greater than a diameter to which the first portion of the frame expands.