Method for anchoring a mitral valve

• US 8,672,998 B2
• Filed: 04/29/2013
• Issued: 03/18/2014
• Est. Priority Date: 06/28/2006
• Status: Active Grant

• Current Assignee: Kardium Inc.
• Original Assignee: Kardium Inc.
• Inventors: Lichtenstein, Samuel Victor, Gelbart, Daniel
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US13/872,870
• Publication Number:
  US 20130238089A1
• Time in Patent Office: 323 Days
• Field of Search: 623 21- 219, 623/1.24, 623/1.26, 623/2.36, 623/2.37, 606/108
• US Class Current: 623/2.1
• 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 2/2433 using balloon catheter
• 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 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 2250/006 modular

Abstract

An artificial mitral valve is anchored in the left atrium by placing the valve between the annulus of the natural mitral valve and an artificial annulus. The artificial annulus is formed by inserting a tool into the coronary sinus, and adjusting the tool to force the wall of the left atrium to form an annulus above the artificial valve, this locking it in place and forming a hemostatic seal.

Claims

1. A method for anchoring an artificial mitral valve in a left atrium of a heart, the method comprising:

deploying the artificial mitral valve in the left atrium of the heart;

positioning the artificial mitral valve above a natural annulus of a natural mitral valve in the heart; and

shaping an atrial wall to form an artificial annulus to anchor artificial mitral valve.

2. The method of claim 1 wherein shaping an atrial wall to form an artificial annulus includes shaping the atrial wall to form the artificial annulus at least one of above or around the artificial mitral valve.

3. The method of claim 1, further comprising:

percutaneously deploying the artificial mitral valve in the left atrium.

4. The method of claim 1 further comprising:

inserting a tool in the coronary sinus to at least partially form the artificial annulus.

5. The method of claim 1 wherein deploying the artificial mitral valve includes expanding a balloon.

6. The method of claim 1, further comprising:

permanently installing a tool in the coronary sinus to at least partially form the artificial annulus.

7. A method to replicate a function of a natural mitral valve in a left atrium of a heart, the natural mitral valve about which a coronary sinus of the heart at least partially extends, the method comprising:

inserting an artificial mitral valve inside an opening formed by the natural mitral valve in the left atrium of the heart;

inserting an elongate member in a flexible state at least partially into the coronary sinus while in the flexible state such that the elongate member at least partially encircles a portion of the artificial mitral valve; and

while the elongate member is at least partially in the coronary sinus, transitioning the elongate member from the flexible state to a more rigid state in which the elongate member forms an artificial annulus to physically secure the artificial mitral valve in the opening.

8. The method of claim 7, further comprising:

adjusting the elongate member during the installation in the heart; and

removing the elongated member from the coronary sinus at a later date.

9. The method of claim 7 wherein the elongate member comprises a plurality of rigid links and a cable that connects the rigid links, and transitioning the elongate member from the flexible state to a more rigid state includes tensioning of the cable.

10. The method of claim 7, further comprising:

percutaneously delivering the elongate member to the left atrium of the heart via a detachable adjustment tool.

11. The method of claim 7, further comprising:

delivering the elongate member via a catheter using an adjustment tool, and detaching the elongate member from the adjustment tool to expose at least one elastic barb on the elongate member.

12. The method of claim 7, further comprising:

delivering the elongate member via a catheter using an adjustment tool to which the elongate member is detachably magnetically coupled.

13. The method of claim 7, further comprising:

securing the artificial mitral valve without sutures between said artificial annulus and the heart.

14. A method to replicate a function of a natural mitral valve in a left atrium of a heart, a coronary sinus of the heart forming a path extending at least partially about the natural mitral valve, the method comprising:

percutaneously inserting an artificial mitral valve inside an opening formed by the natural mitral valve of the heart;

percutaneously inserting an elongate member in a flexible state in the coronary sinus; and

percutaneously adjusting a dimension of the elongate member to form an artificial annulus in the coronary sinus to physically secure the artificial mitral valve in the opening without any sutures between the artificial mitral valve and the heart.

15. The method of claim 14, further comprising:

delivering the artificial mitral valve and the elongate member via a catheter.

16. The method of claim 14 wherein the elongate member comprises a plurality of rigid links and a cable that connects the rigid links, and percutaneously adjusting a dimension of the elongate member includes tensioning the cable.

17. The method of claim 14 wherein percutaneously adjusting a dimension of the elongate member includes tensioning the elongate member into the more rigid state to apply a radially inward force to an annulus of the artificial mitral valve via the coronary sinus to secure the annulus of the artificial valve between a natural annulus of the natural mitral valve and the artificial annulus formed by the elongate member.

18. The method of claim 14 wherein percutaneously adjusting a dimension of the elongate member includes moving a tension adjustment coupler in one direction to increase a tension in the elongate member or moving the tension adjustment coupler in another direction to decrease the tension in the elongate member.

19. The method of claim 18 wherein the tension adjustment coupler is part of a magnetic coupler assembly, and further comprising:

magnetically mating the magnetic coupler assembly with a portion of an adjustment tool which portion is at least partially percutaneously receivable in the heart.