Magnetic retaining mechanisms for prosthetic valves

• US 10,195,028 B2
• Filed: 09/09/2014
• Issued: 02/05/2019
• 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.
• Primary Examiner(s): Yabut, Diane
• Assistant Examiner(s): Jamialahmadi, Majid
• Application Number:
  US14/481,554
• Publication Number:
  US 20150127093A1
• Time in Patent Office: 1,610 Days
• Field of Search: 623 238, 623 21
• 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 method, comprising:

placing a guidewire around native chordae tendineae and/or native leaflets of a mitral valve of a heart, wherein the guidewire is a second guidewire, which is placed while a previously inserted first guidewire remains inside the heart and encircles the native chordae tendineae and/or native leaflets of the mitral valve;

advancing a support member over the guidewire so that the support member at least partially surrounds the native chordae tendineae and/or native leaflets of the mitral valve, the support member comprising a main body having first and second opposing ends, and a longitudinal axis extending from the first end to the second end, the support member further comprising a male magnetic member extending from the first end along the longitudinal axis and a female magnetic member at the second end and having a receiving area extending coaxially along the longitudinal axis, and wherein the support member is releasably coupled to a distal end of a shaft of a delivery catheter and advancing the support member over the guidewire comprises pushing the support member over the guidewire with the shaft;

manipulating the guidewire and/or the shaft to bring the male magnetic member and the female magnetic member into sufficient proximity to each other such that a magnetic connection is established between the male and female magnetic members, and wherein the male magnetic member slides axially into the receiving area of the female magnetic member along the longitudinal axis when the magnetic connection is established between the male and female magnetic members so as to transform the support member into 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 heart valve and an inside surface of the support ring.

2. The method of claim 1, wherein the main body comprises an inflatable balloon and the method further comprises inflating the balloon with an inflating medium.

3. The method of claim 2, wherein the act of inflating the balloon occurs after the act of connecting the male magnetic member to the female magnetic member.

4. The method of claim 2, wherein the male magnetic member comprises a filling nozzle that extends from the first end and is in fluid communication with an interior of the balloon, wherein the act of inflating the support member with the inflating medium comprises introducing the inflating medium into the balloon via the filling nozzle.

5. The method of claim 4, wherein the filling nozzle comprises a one-way valve configured to allow the inflating medium to flow through the filling nozzle and into the balloon but prevent the inflating medium inside the balloon to flow outwardly through the filling nozzle.

6. The method of claim 2, wherein the support member comprises a shaft extending through the balloon, the shaft comprising a plurality of openings along a length thereof in fluid communication with an interior of the balloon, wherein the act of inflating the support member with the inflating medium comprises introducing the inflating medium into the balloon via the shaft and the openings in the shaft.

7. The method of claim 2, wherein the balloon comprises an inner wall facing radially inwardly and an outer wall facing radially outwardly when the support member forms the support ring, wherein the inner wall is thinner than the outer wall.

8. The method of claim 1, wherein the support member is advanced through a femoral artery, through the aortic valve and into the left ventricle before surrounding the native chordae tendineae and/or native leaflets of the mitral valve.

9. The method of claim 1, wherein the support member is advanced into the heart via a transapical approach before surrounding the native chordae tendineae and/or native leaflets of the mitral valve.

10. The method of claim 1 further comprising disconnecting the support member from the shaft and retracting the shaft and the guidewire from the heart, thereby leaving the support member surrounding the native chordae tendineae and/or native leaflets of the mitral valve.

11. The method of claim 1, wherein the second guidewire is stiffer than the first guidewire.

12. The method of claim 1, wherein the support member comprises at least one distensible portion that is more distensible than remaining portions of the support member, wherein the distensible portion is configured to abut the native chordae tendineae.

13. The method of claim 1, wherein the support member comprises a flexible band and a stiffening member extending through the main body, the flexible band being more distensible than the stiffening member, wherein the flexible band is located radially inward relative to the stiffening member when the support member forms the support ring.

14. The method of claim 13, wherein the support member further comprises an internal support ring surrounding the flexible band and the stiffening member, wherein the internal support ring is more distensible than the stiffening member but less distensible than the flexible band.

15. The method of claim 1, wherein the support member comprises an internal support ring extending through the main body, a stiffening member embedded in the internal support ring and a central lumen extending through the internal support ring, the internal support ring being more distensible than the stiffening member, wherein the central lumen is located radially inward relative to the stiffening member when the support member forms the support ring such that the support member can collapse inward and into the central lumen when pressed against a surrounded structure.