Granted Patent B2

US 12,690,965 · App. 17/809,869 · Granted Jul 28, 2026

Inventors: Darshin S. Patel (Lake Forest, CA); Boaz Manash (Givat Ada, IL); Tri D. Tran (Fountain Valley, CA); Ofir Witzman (Harish, IL); Yoav Rozen (Binyamina, IL); Alexander J. Siegel (Irvine, CA); David M. Taylor (Lake Forest, CA)

Assignee: Edwards Lifesciences Corporation

A61F2/2436A61F2/2409A61F2/2418A61F2/2412A61F2210/0014A61F2220/0008

Abstract

Claims (35)

1 . A system for anchoring a prosthetic valve to a native valve of a patient's heart, the system comprising:

a steerable catheter having a first lumen with a distal opening in a distal portion of the steerable catheter;

a sleeve configured for delivery through the first lumen, the sleeve having a second lumen;

an anchoring device configured for delivery through the second lumen such that the sleeve fits around at least a portion of the anchoring device;

wherein the anchoring device comprises an upper portion configured to extend to a first side of the native valve, a lower portion configured to extend to a second side of the native valve, and an upturned portion connecting the lower and upper portions;

wherein the upper portion is disposed around a first open area and the lower portion is disposed around a second open area such that the anchoring device is configured to accept a prosthetic valve; and

wherein the upturned portion comprises a shape-set material having a first shape when disposed within the second lumen and a second shape when disposed outside the second lumen.

2 . The system according to claim 1 , wherein the native valve is a mitral valve.

3 . The system of claim 1 , wherein the upturned portion comprises an upward bend.

4 . The system of claim 1 , wherein the upturned portion comprises an upward bend having an L-shape.

5 . The system of claim 1 , wherein:

the anchoring device, configured such that when in position in the native valve, comprises an encircling coil, one or more functional coils, and a stabilizing coil; and

the upturned portion comprises an upward bend connecting the stabilizing coil to the one or more functional coils or the encircling coil.

6 . The system of claim 1 , wherein the upper portion comprises one or more first coils, the lower portion comprises one or more second coils, and the upturned portion comprises an upward bend between the one or more first and second coils.

7 . A system for anchoring a prosthetic valve to a native valve of a patient's heart, the system comprising:

a steerable catheter having a first lumen with a distal opening in a distal portion of the steerable catheter;

a sleeve configured for delivery through the first lumen, the sleeve having a second lumen;

an anchoring device configured for delivery through the second lumen such that the sleeve fits around at least a portion of the anchoring device;

a pusher configured to advance the sleeve and the anchoring device out of the distal opening of the steerable catheter and into position in the native valve;

wherein the sleeve is configured to be removed from the anchoring device to expose an exterior surface of the anchoring device when the anchoring device is in position in the native valve;

wherein the anchoring device comprises an upper portion configured to extend to a first side of the native valve, a lower portion configured to extend to a second side of the native valve, and an upturned portion connecting the lower and upper portions;

wherein the upper portion comprises a coil that is disposed around a first open area and the lower portion comprises a coil that is disposed around a second open area such that the anchoring device is configured to accept a prosthetic valve; and

wherein the upturned portion comprises a shape-set material having a first shape when disposed within the second lumen and a second shape when disposed outside the second lumen.

8 . The system of claim 7 , wherein the pusher is configured to push against a proximal end of the anchoring device to hold the anchoring device in position in the native valve during removal of the sleeve.

9 . The system of claim 8 , wherein the sleeve is configured to be pulled proximally off of the anchoring device when the pusher holds the anchoring device in position in the native valve.

10 . The system of claim 7 , wherein the pusher is configured to push a first portion of the sleeve and the anchoring device out of the steerable catheter to the first side of the native valve and wherein the steerable catheter is configured to be retracted to release a second portion of the sleeve and the anchoring device on the second side of the native valve.

11 . The system according to claim 7 , wherein the native valve is a mitral valve.

12 . The system of claim 7 , wherein the distal portion of the steerable catheter comprises a first flexing section configured to form a first curved portion and a second flexing section configured to form a curved planar portion.

13 . The system according to claim 12 , wherein the steerable catheter comprises a first pull wire configured to be actuated to form the first curved portion and a second pull wire configured to be actuated to form the curved planar portion.

14 . The system of claim 13 , wherein the first flexing section includes a plurality of links, each link aligned with and integrally connected to an adjacent link.

15 . The system according to claim 7 , further comprising a suture looped through an eyelet at a proximal end of the anchoring device while delivering the anchoring device at the native valve through the steerable catheter.

16 . The system of claim 7 , wherein the upturned portion comprises an upward bend.

17 . The system of claim 7 , wherein the upturned portion comprises an upward bend having an L-shape.

18 . The system of claim 7 , wherein the upturned portion comprises first and second curved portions and an upturned bend therebetween.

19 . The system of claim 7 , wherein the upper portion comprises a first orientation, the lower portion comprises a second orientation, and the upturned portion comprises a third orientation different from the first and second orientations.

Assignments (1)

Continuity (5)

References Cited (373)