Devices, systems and methods for delivering a prosthetic mitral valve and anchoring device

• US 10,052,199 B2
• Filed: 02/20/2015
• Issued: 08/21/2018
• Est. Priority Date: 02/21/2014
• 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): Rosen, Eric
• Assistant Examiner(s): Igboko, Chima
• Application Number:
  US14/628,060
• Publication Number:
  US 20150238313A1
• Time in Patent Office: 1,278 Days
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/006 modular

Abstract

Prosthetic mitral heart valves and anchors for use with such valves are provided that allow for an improved implantation procedure. In various embodiments, a helical anchoring device is formed as a coiled or twisted anchor that includes one or more turns that twist or curve around a central axis. Curved arms attached to the frame of the valve guide the helical anchoring device into position beneath the valve leaflets and around the mitral valve annulus as it exits the delivery catheter, and the expandable prosthetic mitral valve is held within the coil of the anchoring device. The anchoring device and the valve can be delivered together, simplifying the valve replacement procedure.

Claims

1. A mitral valve prosthesis configured to be implanted at a native mitral valve of a heart, the native mitral valve having native mitral valve leaflets, the mitral valve prosthesis comprising:

an expandable valve frame; and

a plurality of arms each connected to the valve frame at or near a first end of the valve frame;

wherein a first arm from among the plurality of arms has a shape that is different from a shape of each of the other arms, and wherein the mitral valve prosthesis further comprises an anchoring device comprising a coil that defines an inner space for receiving the valve frame, the first arm being configured to guide the anchoring device around the valve frame, wherein when the mitral valve prosthesis is implanted, the native mitral valve leaflets are positioned between the anchoring device and the valve frame and the anchoring device is positioned radially between the plurality of arms and the valve frame.

2. The mitral valve prosthesis of claim 1, wherein a loop is formed at an end of the first arm and is sized such that the anchoring device can pass therethrough.

3. The mitral valve prosthesis of claim 2, wherein the end of the first arm is bent to form the loop.

4. The mitral valve prosthesis of claim 1, wherein the first arm comprises a hollow tube sized to allow the anchoring device to pass therethrough.

5. The mitral valve prosthesis of claim 4, wherein the hollow tube extends from the connection at the valve frame to an opposite end of the first arm.

6. The mitral valve prosthesis of claim 4, wherein an end of the first arm is bent, such that a portion of the hollow tube extends circumferentially around the valve frame.

7. The mitral valve prosthesis of claim 1, wherein the first arm is of a heavier construction than each of the other arms.

8. The mitral valve prosthesis of claim 1, where when the valve frame is in an expanded configuration, at least one of the arms is curved and has a section that is axially aligned and positioned radially outside of the valve frame.

9. A valve prosthesis configured to be implanted at a native valve of a heart, the native valve having native valve leaflets, the valve prosthesis comprising:

an expandable valve frame;

a first arm having a first end attached to the valve frame and a second end configured to extend farther radially from a central axis of the valve frame than the valve frame extends from the central axis when the valve frame is in an expanded configuration, wherein the first arm has a shape that is different from a shape of a second arm coupled to the valve frame; and

an anchoring device comprising a coil that defines an inner space for receiving the expandable valve frame, wherein the first arm is configured to guide the anchoring device around the valve frame;

wherein the valve prosthesis is configured such that, when implanted, the valve frame can be held by the anchoring device with the native valve leaflets positioned between the anchoring device and the valve frame, when the valve frame is in the expanded configuration in the inner space of the coil.

10. The valve prosthesis of claim 9, wherein the first arm comprises a loop through which the anchoring device is configured to pass.

11. The valve prosthesis of claim 9, wherein the first arm comprises a hollow tube configured to hold the anchoring device to allow the anchoring device to pass therethrough.

12. A method for delivering a mitral valve prosthesis to a native mitral valve of a heart, the mitral valve prosthesis comprising a valve frame configured to expand from a first collapsed configuration to a second expanded configuration, an arm connected to the valve frame, and an anchoring device comprising a coil, the method comprising:

positioning a catheter at the native mitral valve;

advancing the arm and a first end of the valve frame out of the catheter to a left ventricle of the heart;

advancing the anchoring device out of the catheter into the left ventricle around leaflets and chordae tendineae of the native mitral valve, wherein the anchoring device is guided by at least a portion of the arm during the advancing of the anchoring device; and

advancing remaining portions of the valve frame out of the catheter, wherein the valve frame is expanded and held in an inner space defined by the coil of the anchoring device.

13. The method of claim 12, wherein the anchoring device is guided through at least a portion of the arm during the advancing of the anchoring device.

14. The method of claim 12, wherein the mitral valve prosthesis comprises a plurality of arms connected to the valve frame at or near the first end.

15. The method of claim 14, wherein the plurality of arms are configured to extend around the leaflets of the native mitral valve.

16. The method of claim 15, wherein the anchoring device is configured to be positioned between the arms and the valve frame in a radial direction relative to a central axis of the valve frame.

17. The method of claim 14, wherein the anchoring device forms a common plane for supporting the plurality of arms.