Method for anchoring a mitral valve

• US 9,192,468 B2
• Filed: 01/23/2014
• Issued: 11/24/2015
• 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:
  US14/162,469
• Publication Number:
  US 20140135913A1
• Time in Patent Office: 670 Days
• US Class Current: 1/1
• 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 device to anchor an artificial mitral valve via a coronary sinus of a heart, the coronary sinus which at least partially extends about a natural mitral valve of the heart, the artificial mitral valve being insertable inside an opening formed by the natural mitral valve in a left atrium of the heart to replicate a function of the natural mitral valve, the device comprising:

a terminal link comprising a guide wire bore sized and dimensioned to receive a guide wire therethrough, the guide wire configured to provide a path to the coronary sinus, and the guide wire bore comprising an entry point in a first portion of the terminal link and an exit point in a second portion of the terminal link different from the first portion;

a first cable comprising a first end, the first end of the first cable attached to the terminal link; and

a series of non-terminal links each having a first end and a second end spaced apart from each other along a longitudinal axis and a first cable bore extending between the first end and the second end of the respective non-terminal link that receives the first cable therethrough, wherein a tension of the first cable is adjustable to transition the device between a flexible state wherein the series of non-terminal links are freely movable with respect to each other and a more rigid state wherein the series of non-terminal links are substantially fixed with respect to each other, the device being at least partially insertable into the coronary sinus in the flexible state such that the series of non-terminal links and the terminal link at least partially encircle a portion of the artificial mitral valve, and which device forms an artificial annulus in the more rigid state to physically secure the artificial mitral valve in the opening.

2. The device of claim 1, further comprising a tension adjustment coupler proximate a second end of the first cable opposite the first end of the first cable, wherein movement of the tension adjustment coupler in one direction increases the tension in the first cable and movement of the tension adjustment coupler in another direction decreases the tension in the first cable.

3. The device of claim 2 wherein the second portion of the terminal link is an end of the terminal link.

4. The device of claim 2 wherein the tension adjustment coupler comprises a nut and a tightening screw threadably coupled with the nut.

5. The device of claim 4 wherein the tightening screw comprises a guide wire bore sized and dimensioned to receive the guide wire therethrough.

6. The device of claim 1 wherein the series of non-terminal links each further comprises a guide wire bore sized and dimensioned to receive the guide wire therethrough.

7. The device of claim 1 wherein the first end of each of the non-terminal links comprises a first surface and the second end of each of the non-terminal links comprises a second surface, the first and the second surfaces being disposed in a configuration such that when the tension of the first cable is applied, the first surface of one of the non-terminal links abuts the second surface of an adjacent one of the non-terminal links to selectively fix the non-terminal links in a predetermined orientation.

8. The device of claim 7 wherein the first surface and the second surface of each of the non-terminal links are positioned at an oblique angle relative to the respective longitudinal axis such that the longitudinal axes of adjacent non-terminal links are non-parallel when the device is in the more rigid state.

9. The device of claim 7 wherein the first surface and the second surface of each of the non-terminal links are positioned such that the non-terminal links fit in a single plane when the device is in the more rigid state.

10. The device of claim 7 wherein the first surface of at least one subset of the non-terminal links comprises a first alignment profile and the second surface of the at least one subset of the non-terminal links comprises a second alignment profile complementary to the first alignment profile such that, when the device is in the more rigid state, the first and the second alignment profiles of adjacent non-terminal links join together to maintain alignment of adjacent links at a predetermined orientation.

11. The device of claim 7 wherein the first surface and the second surface of each of the non-terminal links are positioned such that the non-terminal links acquire a non-single plane, three-dimensional shape when the device is in the more rigid state.

12. The device of claim 1, further comprising a second cable, the series of non-terminal links each having a second cable bore extending between the first end and the second end of the respective non-terminal link that receives the second cable therethrough, a first end of the second cable being attached to the terminal link.

13. The device of claim 12, further comprising a tension adjustment coupler attached to a second end of the first cable opposite the first end of the first cable, wherein movement of the tension adjustment coupler in one direction increases the tension in the first cable and movement of the tension adjustment coupler in another direction decreases the tension in the first cable, the second cable comprising a second end opposite the first end of the second cable, the second end of the second cable being free from attachment to the tension adjustment coupler.

14. The device of claim 13 wherein the tension adjustment coupler comprises a nut and a screw threadably coupled with the nut, the screw comprising a ferromagnetic material.

15. The device of claim 1 wherein the terminal link is arranged to be inserted into the coronary sinus ahead of the series of non-terminal links.

16. A device to anchor an artificial mitral valve via a coronary sinus of a heart, the coronary sinus which at least partially extends about a natural mitral valve of the heart, the artificial mitral valve being insertable inside an opening formed by the natural mitral valve in a left atrium of the heart to replicate a function of the natural mitral valve, the device comprising:

a terminal link configured to be inserted furthermost into the coronary sinus, the terminal link comprising a guide wire bore sized and dimensioned to receive a guide wire therethrough, the guide wire bore comprising an entry point in a first portion of the terminal link and an exit point in a second portion of the terminal link different from the first portion; and

a series of non-terminal links each having a first end and a second end spaced apart from each other along a longitudinal axis, wherein the device having a flexible state wherein the series of non-terminal links are freely movable with respect to each other and a more rigid state wherein the series of non-terminal links are substantially fixed with respect to each other, the device being at least partially insertable into the coronary sinus in the flexible state such that the series of non-terminal links and the terminal link at least partially encircle a portion of the artificial mitral valve, and which device forms an artificial annulus in the more rigid state to physically secure the artificial mitral valve in the opening.