Mitral repair and replacement devices and methods

• US 10,016,272 B2
• Filed: 09/10/2015
• Issued: 07/10/2018
• Est. Priority Date: 09/12/2014
• Status: Active Grant

• Current Assignee: Mitral Valve Technologies Sarl (Edwards Lifesciences Corporation)
• Original Assignee: Mitral Valve Technologies Sarl (Edwards Lifesciences Corporation)
• Inventors: Spence, Paul A., Tompkins, Landon H.
• Primary Examiner(s): Baria, Dinah
• Application Number:
  US14/850,822
• Publication Number:
  US 20160074165A1
• Time in Patent Office: 1,034 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

An implant and method for repairing and/or replacing functionality of a native mitral valve are in various embodiments configured to reduce or eliminate mitral regurgitation and residual mitral valve leakage. A coiled anchor with a central turn that reduces in size upon implantation is used to approximate the amount of reduction in the size and the reshaping of the native mitral annulus to reduce valve leakage. A clip can be further applied to the native valve leaflets to reduce the size of the native mitral annulus and leakage therethrough. A prosthetic heart valve can be implanted in the coiled anchor to replace and further improve functionality of the valve. In some cases, the prosthetic valve can be implanted in a clipped valve, where the clip is detached from one of the native valve leaflets to provide space for the prosthetic valve to expand.

Claims

1. An implant for a native mitral valve of a heart, the implant comprising a coiled anchor that comprises:

an upper turn defining an upper turn diameter;

a central turn connected to the upper turn, the central turn defining a central turn diameter that is larger than the upper turn diameter defined by the upper turn; and

a lower turn connected to the turn, the lower turn defining a lower turn diameter that is smaller than said central turn diameter;

wherein the coiled anchor is configured to be implanted at the native mitral valve with at least a portion of the central turn of the coiled anchor positioned in a left ventricle of the heart and around valve leaflets of the native mitral valve;

wherein the central turn, the upper turn, and the lower turn are configured such that when a radially outward pressure is applied to at least one of the upper turn or the lower turn, the coiled anchor is biased such that the central turn diameter is reduced and the central turn diameter, the upper turn diameter, and the lower turn diameter become substantially equal to one another.

2. The implant of claim 1, further comprising a stent comprising an expandable frame configured to be expanded in an inner space defined by the upper turn, the central turn, and the lower turn of the coiled anchor.

3. The implant of claim 2, wherein the stent is expandable to a diameter that is greater than the upper turn diameter or the lower turn diameter when the coiled anchor is unbiased.

4. The implant of claim 2, wherein the stent is covered by a cover layer.

5. The implant of claim 2, wherein at least one of the upper turn and the lower turn of the coiled anchor is configured to attach to an outer surface of the stent.

6. The implant of claim 2, further comprising a clip configured to hold respective ends of the valve leaflets of the native mitral valve together.

7. The implant of claim 6, further comprising a prosthetic valve comprising an expandable frame that houses a plurality of leaflets for controlling blood flow therethrough, wherein the prosthetic valve is expandable to a diameter that is at least the diameter of the stent when the stent is expanded, such that the prosthetic valve is configured to be held in the stent.

8. The implant of claim 7, wherein an outer surface of the expandable frame of the prosthetic valve comprises at least one cutting feature, wherein the cutting feature comprises a surface configured to cut portions of a native mitral valve.

9. The implant of claim 2, further comprising a prosthetic valve comprising an expandable frame that houses a plurality of leaflets for controlling blood flow therethrough, wherein the prosthetic valve is expandable to a diameter that is at least the diameter of the stent when the stent is expanded, such that the prosthetic valve is configured to be held in the stent.

10. An implant for a native mitral valve of a heart, the implant comprising a coiled anchor that comprises:

an upper turn defining an upper turn diameter of approximately 25 mm;

a central turn connected to the upper turn, the central turn defining a central turn diameter of approximately 35 mm; and

a lower turn connected to the central turn, the lower turn defining a lower turn diameter of approximately 25 mm;

wherein the coiled anchor is configured to be implantable at the native mitral valve with at least a portion of the central turn of the coiled anchor positioned in a left ventricle of the heart and around valve leaflets of the native mitral valve.

11. The implant of claim 10, wherein the central turn, the upper turn, and the lower turn are configured such that when a radially outward pressure is applied to at least one of the upper turn or the lower turn, the central turn diameter is reduced and the central turn diameter, the upper turn diameter, and the lower turn diameter become substantially equal to one another.

12. The implant of claim 10, further comprising a stent comprising an expandable frame configured to be expanded in an inner space defined by the upper turn, the central turn, and the lower turn of the coiled anchor.

13. The implant of claim 12, wherein the stent is expandable to a diameter that is greater than 25 mm.

14. The implant of claim 12, wherein the stent is covered by a cover layer.

15. The implant of claim 12, wherein at least one of the upper turn and the lower turn of the coiled anchor is configured to attach to an outer surface of the stent.

16. The implant of claim 15, further comprising a prosthetic valve comprising an expandable frame that houses a plurality of leaflets for controlling blood flow therethrough, wherein the prosthetic valve is expandable to a diameter that is at least the diameter of the stent when the stent is expanded, such that the prosthetic valve is configured to be held in the stent.

17. The implant of claim 16, wherein an outer surface of the expandable frame of the prosthetic valve comprises at least one cutting feature, wherein the cutting feature comprises a surface configured to cut portions of a native mitral valve.

18. The implant of claim 12, further comprising a prosthetic valve comprising an expandable frame and that houses a plurality of leaflets for controlling blood flow therethrough, wherein the prosthetic valve is expandable to a diameter that is at least the diameter of the stent when the stent is expanded, such that the prosthetic valve is configured to be held in the stent.

19. A system for a mitral valve comprising:

a coiled implant, and a prosthetic valve;

wherein the coiled implant comprises

an upper turn having an upper turn diameter,

a central turn connected to the upper turn, the central turn defining a central turn diameter that is larger than the upper turn diameter, and

a lower turn connected to the central turn, the lower turn defining a lower turn diameter that is smaller than of the central turn diameter; and

wherein the prosthetic valve comprises

an expandable frame that is expandable to a maximum expanded diameter, and

a plurality of leaflets disposed within the expandable frame, for controlling bloodflow through the prosthetic valve;

wherein the coiled anchor is configured to be implantable at the native mitral valve with at least a portion of the central turn of the coiled anchor positioned in a left ventricle of the heart and around valve leaflets of the native mitral valve, and

wherein the central turn, the upper turn, and the lower turn are configured such that when a radially outward pressure is applied to at least one of the upper turn or the lower turn, the central turn diameter is reduced to a reduced diameter and the central turn diameter, the upper turn diameter, and the lower turn diameter become substantially equal to the reduced diameter, and the maximum expanded diameter of the prosthetic valve is at least the same as or greater than the reduced diameter.

20. The system of claim 19, wherein at least one of the upper and lower turns of the coiled anchor is configured to attach to an outer surface of the prosthetic valve.