Granted Patent B2

US 12,285,334 · App. 18/350,555 · Granted Apr 29, 2025

Inventors: Stanton J. Rowe (Newport Coast, CA); Francesco Maisano (Zurich, CH); Oded Meiri (Ram-On, IL)

Assignee: EDWARDS LIFESCIENCES CORPORATION

A61F2/2427A61F2/2409A61F2/2412A61F2/2418A61F2/2433A61F2/2436A61F2/2445A61B17/0467A61B2017/32004A61F2220/0016A61F2230/0054A61F2250/006A61F2310/00023A61M2025/0004A61M25/10A61M25/104

Abstract

Claims (30)

1. A method for treating a deficient native mitral valve, the method comprising:

advancing the distal end portion of a delivery catheter into a heart through a blood vessel of a patient until the distant end portion reaches a selected implantation site, wherein the delivery catheter contains a loop delivery catheter containing a support band stretched into a linear form, wherein the support band comprises a shape-memory material;

steering the distal end portion of the loop delivery catheter such that it curves partially around the native leaflets of the native mitral valve; and

ejecting the support band from the distal end portion of the loop delivery catheter by pushing the support band using a pusher shaft such that the support band transitions from the linear form to a curved shape extending around native leaflets of the native mitral valve such that the support band is disposed in a plane substantially parallel to a plane of an annulus of the native mitral valve and perpendicular to a direction of the flow of blood through the native mitral valve;

positioning an expandable prosthetic heart valve within an interior of the native mitral valve while the prosthetic heart valve is in a compressed shape; and

expanding the prosthetic heart valve, thereby causing an exterior surface of the prosthetic heart valve to urge the native leaflets of the native mitral valve against an interior surface of the support band and to frictionally secure the prosthetic heart valve to the native leaflets of the native mitral valve.

2. The method of claim 1 , wherein the support band is made of Nitinol.

3. The method of claim 1 , wherein the support band includes one or more barbs.

4. The method of claim 1 , further comprising clamping the support band onto the native leaflets.

5. The method of claim 1 , wherein the support band and the prosthetic heart valve are delivered separately using separate catheters.

6. The method of claim 1 , wherein the support band forms a loop extending fully around at least one leaflet of the native leaflets when ejected from the delivery catheter.

7. A method for treating a deficient native mitral valve, the method comprising:

advancing the distal end portion of a delivery catheter transvascularly into a heart, wherein the delivery catheter contains a loop delivery catheter containing a support band in a non-coiled, stretched configuration, wherein the support band comprises a shape-memory material;

positioning a distal end portion of the loop delivery catheter fully around at least one native leaflet of the native mitral valve in the left ventricle;

pushing the support band from the distal end portion of the loop delivery catheter using a pusher shaft such that the support band transitions from the stretched configuration to a curved shape extending fully around at least one native leaflet of the native mitral valve in a circumferential direction around an axis extending along a direction of blood flow through the native mitral valve;

clamping the support band onto the native leaflets of the native mitral valve;

positioning an expandable prosthetic heart valve within an interior of the native mitral valve while the prosthetic heart valve is in a compressed shape; and

expanding the prosthetic heart valve, thereby causing an exterior surface of the prosthetic heart valve to urge the native leaflets of the native mitral valve against an interior surface of the support band and to frictionally secure the prosthetic heart valve to the native leaflets of the native mitral valve.

8. The method of claim 7 , wherein the support band is made of Nitinol.

9. The method of claim 7 , wherein the support band includes one or more barbs.

10. A method for treating a deficient native mitral valve, the method comprising:

advancing a catheter delivery sheath through a blood vessel of a patient into a heart;

advancing a distal end portion of a loop delivery catheter from a distal end of the catheter delivery sheath to position the distal end portion of the loop delivery catheter that has been advanced from the catheter delivery sheath fully around at least one native leaflet of the native mitral valve in the left ventricle;

advancing a support band through the loop delivery catheter and around native leaflets of the native mitral valve by pushing the support band using a pusher shaft such that the support band is disposed in a plane substantially parallel to a plane of an annulus of the native mitral valve and perpendicular to a direction of the flow of blood through the native mitral valve;

wherein the support band extends fully around at least one native leaflet of the native mitral valve in a circumferential direction around an axis extending along a direction of blood flow through the native mitral valve;

positioning an expandable prosthetic heart valve within an interior of the native mitral valve while the prosthetic heart valve is in a compressed shape; and

expanding the prosthetic heart valve, thereby causing an exterior surface of the prosthetic heart valve to urge the native leaflets of the native mitral valve against an interior surface of the support band and to frictionally secure the prosthetic heart valve to the native leaflets of the native mitral valve.

11. The method of claim 10 , further comprising clamping the support band to the native leaflets of the native mitral valve.

12. The method of claim 10 , wherein the support band is made of Nitinol.

13. The method of claim 10 , wherein the support band includes one or more barbs.

Assignments (1)

Continuity (10)

References Cited (323)