MAGNETIC RETAINING MECHANISMS FOR PROSTHETIC VALVES

• US 20150127093A1
• Filed: 09/09/2014
• Published: 05/07/2015
• Est. Priority Date: 09/10/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Hosmer, Ronald J., Spinner, Erin M.
• Granted Patent: US 10,195,028 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support member is positioned to at least partially surround the native chordae tendineae and/or leaflets of a valve. The support member can comprise a flexible, distensible material to reduce abrasion and other mechanical damage to surrounding structures. A locking member may be used to couple both ends of the support member, forming a support ring. The support member may have two magnetic end portions which can be magnetically coupled to form a support ring. An expandable prosthetic heart valve can be delivered into the native heart valve and expanded within the support band, thereby causing one or more of the native chordae tendineae and/or leaflets of the native heart valve to be frictionally secured between the support ring and the expanded prosthetic heart valve.

Claims

1. A support member for at least partially surrounding native chordae tendineae and/or leaflets of a heart valve to facilitate the securing of a prosthetic heart valve in the valve annulus by frictionally engaging the native chordae tendineae and/or leaflets between the support member and the prosthetic valve, the support member comprising:

a flexible elongated main body having first and second ends; and

first and second magnetic end portions coupled to the first and second ends, respectively, of the main body, wherein the magnetic end portions are configured to join magnetically to form a continuous support ring.

2. The support member of claim 1, wherein the first magnetic end portion comprises a magnetic protruding member and the second magnetic end portion comprises a magnetic receiving member configured to receive the protruding member.

4. The support member of claim 1, wherein the elongated main body comprises at least one distensible internal member.

5. The support member of claim 4, wherein the internal member comprises a compliant tube.

6. The support member of claim 1, further comprising a textile wrap covering the main body.

7. The support member of claim 2, wherein the magnetic protruding member comprises a spherical end portion and the magnetic receiving member comprises an at least partially spherical cavity configured to receive the spherical end portion.

8. The support member of claim 1, wherein the main body comprises an inflatable balloon.

9. The support member of claim 8, wherein one of the first and second end portions comprises a filling nozzle in fluid communication with the balloon and configured to be connectable to a conduit that provides an inflating medium for inflating the balloon.

10. The support member of claim 1, wherein the main body comprises a first portion and a second portion, wherein the first portion is configured to contact the native leaflets when implanted and is relatively more distensible than the second portion.

3. The support member of claim 3, wherein the magnetic protruding member comprises a tapered distal end portion and the magnetic receiving member comprises a tapered cavity complementary to the distal end of the magnetic protruding member.

11. A support member for at least partially surrounding native leaflets of a heart valve to facilitate the securing of a prosthetic device in the valve annulus by frictionally engaging the native chordae tendineae and/or leaflets between the support band and the prosthetic valve, the support member comprising:

an elongated main body, a first end portion, and a second end portion;

wherein the first end portion and the second end portion are configured to be connected to each other such that the support member forms a ring surrounding the native chordae tendineae and/or leaflets;

wherein the main body comprises a first portion and a second portion, the first portion being positioned to contact the native chordae tendineae and/or leaflets when the support member is formed into the ring extending around the native chordae tendineae and/or leaflets, the first portion being relatively more distensible than the second portion.

12. The support member of claim 11, wherein the first and second end portions are configured to join magnetically to each other to form the ring.

13. The support member of claim 11, wherein the main body comprises an inflatable balloon configured to be filled with a distensible material.

14. The support member of claim 13, further comprising a filling nozzle configured to introduce an inflating medium into the balloon when fluidly connected to a conduit in fluid communication with a source of the inflating medium.

15. The support member of claim 11, wherein the main body comprises an elastomeric, first elongated member extending the length of the main body, a second elongated member extending the length of the main body, the second elongated member being relatively stiffer than the first elongated member, a fabric cover extending over and covering the first and second elongated members.

16. The support member of claim 11, wherein the main body comprises a first elongated member extending the length of the main body and a stiffening member extending lengthwise through the first elongated member, the stiffening member having a greater stiffness than the first elongated member.

17. The support member of claim 16, further comprising an elastomeric, second elongated member extending lengthwise through the first elongated member, the second elongated member having a greater elasticity than the first elongated member and the stiffening member.

18. The support member of claim 16, further comprising a guidewire lumen extending lengthwise through the first elongated member.

19. The support member of claim 16, wherein the first elongated member comprises a lumen extending lengthwise through the first elongated member and configured to allow an inner portion of the first elongated member to deflect into the lumen so to cushion the force of the support member against adjacent the native chordae tendineae and/or leaflets.

20. The support member of claim 16, further comprising a fabric cover extending over and covering the first elongated member.

21. A method, comprising:

advancing a support member so that the support member at least partially surrounds native chordae tendineae and/or leaflets of a heart valve, the support member comprising a proximal end and a distal end;

connecting the proximal end to the distal end through a magnetic connection to form a support ring; and

expanding a prosthetic heart valve inside the support ring so that the native leaflets and/or chordae tendineae are in contact with an outside surface of the prosthetic device and an inside surface of the support ring.

22. The method of claim 21, further comprising inflating the support member with an inflating medium.

23. The method of claim 22, wherein the act of inflating the support member occurs after the act of connecting the proximal end to the distal end.

24. The method of claim 21, wherein the support member comprises a first magnetic member at the proximal end and a second magnetic member at the distal end, and the act of connecting the proximal end to the distal end comprises placing the first magnetic member in proximity to the second magnetic member such that a magnetic connection is established between the first and second magnetic members.

25. The method of claim 24, wherein the act of connecting the proximal end to the distal end comprises placing the first magnetic member into a receiving area of the second magnetic member.