Mitral repair and replacement devices and methods

• US 10,653,519 B2
• Filed: 07/06/2018
• Issued: 05/19/2020
• 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:
  US16/029,355
• Publication Number:
  US 20180311038A1
• Time in Patent Office: 683 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. A method for delivering an implant to reshape a native mitral valve of a heart, the implant comprising a coiled anchor having a first end, a second end, and a central axis extending between the first and second ends, wherein the coiled anchor defines an inner space coaxial with the central axis and comprises a first turn defining a central portion of the inner space having a first width, a second turn connected to the first turn at the first end of the coiled anchor and defining a portion of the inner space having a width that is smaller than the first width, and a third turn connected to the first turn at the second end of the coiled anchor and defining another portion of the inner space having a width that is smaller than the first width, and a stent comprising an expandable frame, the method comprising:

positioning the coiled anchor at a native mitral valve of a heart of a patient, such that at least a portion of the first turn of the coiled anchor is positioned in a left ventricle of the heart and around valve leaflets of the native mitral valve;

positioning the stent at the native mitral valve through the inner space of the coiled anchor when the stent is in a collapsed state; and

expanding the stent, wherein the stent is expandable to a width that is greater than the width of the inner space defined by at least one of the second turn or the third turn when the coiled anchor is unbiased, such that a radially outward pressure is applied by the stent on the at least one of the second turn or the third turn to increase the width of the portion of the inner space defined by the at least one of the second turn or the third turn, while the width of the portion of the inner space defined by the first turn is decreased to a width that is smaller than the first width.

2. The method of claim 1, wherein after expansion of the stent in the coiled anchor, the widths of the respective portions of the inner space defined by the first turn, the second turn, and the third turn, are substantially equal to one another.

3. The method of claim 1, further comprising applying a clip to ends of the valve leaflets of the native mitral valve for drawing the ends of the valve leaflets closer to one another.

4. The method of claim 3, further comprising:

positioning a prosthetic valve comprising an expandable frame and housing a plurality of leaflets through the expanded stent when the prosthetic valve is in a collapsed state; and

expanding the prosthetic valve, wherein the prosthetic valve is expandable to a width that is at least the width of the expanded stent, such that a radially outward pressure is applied by the frame of the prosthetic valve on the stent to hold the prosthetic valve in the stent.

5. The method of claim 4, further comprising detaching the end of at least one of the valve leaflets of the native mitral valve from the clip.

6. The method of claim 1, further comprising:

positioning a prosthetic valve comprising an expandable frame and housing a plurality of leaflets through the expanded stent when the prosthetic valve is in a collapsed state; and

expanding the prosthetic valve, wherein the prosthetic valve is expandable to a width that is at least the width of the expanded stent, such that a radially outward pressure is applied by the frame of the prosthetic valve on the stent to hold the prosthetic valve in the stent.

7. The method of claim 1, wherein the stent houses a plurality of valve leaflets for controlling blood flow therethrough.

8. A method for delivering an implant to reshape a native valve of a heart, the implant comprising a coiled anchor having a first end, a second end, and a central axis extending between the first and second ends, wherein when unbiased, the coiled anchor defines an inner space coaxial with the central axis and comprises a first turn defining a central portion of the inner space having a first width, a second turn connected to the first turn at the first end of the coiled anchor and defining a portion of the inner space having a second width that is smaller than the first width, and a third turn connected to the first turn at the second end of the coiled anchor and defining another portion of the inner space having a third width that is smaller than the first width, and a stent comprising an expandable frame, the method comprising:

positioning the coiled anchor at a native valve of a heart of a patient, such that at least a portion of the first turn of the coiled anchor is positioned in a ventricle of the heart and around valve leaflets of the native valve;

positioning the stent at the native valve through the inner space of the coiled anchor when the stent is in a collapsed state; and

expanding the stent, wherein the stent is expandable to a fourth width that is greater than at least one of the second width and the third width, such that a radially outward pressure is applied by the stent on the second turn and the third turn such that the portion of the inner space defined by the second turn is wider than the second width and the portion of the inner space defined by the third turn is wider than the third width, while the portion of the inner space defined by the first turn is decreased to a width that is smaller than the first width.

9. The method of claim 8, wherein after expansion of the stent in the coiled anchor, widths of the respective portions of the inner space defined by the first turn, the second turn, and the third turn, are substantially equal to one another.

10. The method of claim 8, further comprising applying a clip to ends of the valve leaflets of the native mitral valve for drawing the ends of the valve leaflets closer to one another.

11. The method of claim 10, further comprising:

positioning a prosthetic valve comprising an expandable frame and housing a plurality of leaflets through the expanded stent when the prosthetic valve is in a collapsed state; and

expanding the prosthetic valve, wherein the prosthetic valve is expandable to a width that is at least the width of the expanded stent, such that a radially outward pressure is applied by the frame of the prosthetic valve on the stent to hold the prosthetic valve in the stent.

12. The method of claim 11, further comprising detaching the end of at least one of the valve leaflets of the native mitral valve from the clip.

13. The method of claim 8, further comprising:

positioning a prosthetic valve comprising an expandable frame and housing a plurality of leaflets through the expanded stent when the prosthetic valve is in a collapsed state; and

expanding the prosthetic valve, wherein the prosthetic valve is expandable to a width that is at least the width of the expanded stent, such that a radially outward pressure is applied by the frame of the prosthetic valve on the stent to hold the prosthetic valve in the stent.

14. The method of claim 8, wherein the stent houses a plurality of valve leaflets for controlling blood flow therethrough.