Systems and methods for implant deployment

Patent metadata

Field	Value
Publication number	US-2024299163-A1
Application number	US-202418658829-A
Country	US
Kind code	A1
Filing date	May 8, 2024
Priority date	Nov 22, 2021
Publication date	Sep 12, 2024
Grant date	—

Abstract

Devices, systems, and methods relate to implants, such as prosthetic valves for replacing native heart valves. Delivery systems for delivering the implants to an implantation site are also disclosed herein. A prosthetic valve may include a valve body supporting a plurality of prosthetic valve leaflets and one or more adjustable anchors coupled to the valve body for anchoring the prosthetic valve to leaflets of a native heart valve, wherein at least one of the adjustable anchors is axially slidable relative to the valve body for conforming to the native anatomy of the native heart valve.

First claim

What is claimed is:

1 . A system for implantation of a prosthetic valve to a native heart valve, the system comprising:
a prosthetic valve including:
a plurality of prosthetic valve leaflets,
a valve frame supporting the plurality of prosthetic valve leaflets, and
one or more anchors for anchoring the prosthetic valve to the native heart valve, wherein at least one of the anchors is axially slidable relative to the valve frame;
a delivery apparatus for delivering the prosthetic valve to the native heart valve, the delivery apparatus including an elongate shaft having a retention area for retaining the prosthetic valve; and a control mechanism for actuating the at least one anchor to axially slide relative to the valve frame, the control mechanism including a tether for controlling retraction of the at least one anchor relative to the valve frame and a pusher shaft for controlling advancement of the at least one anchor relative to the valve frame.

2 . The system of claim 1 , wherein the tether is adapted to release from the at least one anchor upon deployment of the prosthetic valve to the native heart valve.

3 . The system of claim 1 , wherein the control mechanism includes at least one actuator operable by a user to axially slide the at least one anchor relative to the valve frame.

4 . The system of claim 3 , wherein the delivery apparatus includes a handle, and the at least one actuator is positioned on the handle.

5 . The system of claim 1 , wherein the control mechanism is operable to actuate a first one of the anchors to axially slide relative to the valve frame, and is operable to actuate a second one of the anchors to axially slide relative to the valve frame independent from the first one of the anchors.

6 . The system of claim 1 , wherein each of the anchors is formed with a hook shape and is adapted to extend around a downstream end of a leaflet of the native heart valve.

7 . The system of claim 6 , wherein each of the anchors extends radially outwardly to a tip.

8 . The system of claim 1 , wherein the valve frame includes an inner frame and an outer frame positioned radially outward of the inner frame.

9 . The system of claim 1 , wherein at least a portion of the prosthetic valve is manufactured based on imaging of the native heart valve.

10 . The system of claim 1 , wherein the prosthetic valve is sized for replacing a tricuspid or mitral valve.

11 . A system comprising:
a prosthetic valve including:
a plurality of prosthetic valve leaflets,
a valve frame supporting the plurality of prosthetic valve leaflets, and
a plurality of anchors for anchoring the prosthetic valve to a native heart valve, wherein each of the plurality of anchors is movable relative to the valve frame; and
a control mechanism including a motor for actuating movement of the plurality of anchors relative to the valve frame, the motor adapted to actuate movement of at least one of the plurality of anchors independent of a movement of at least one other anchor of the plurality of anchors.

12 . The system of claim 11 , wherein the at least one of plurality the anchors is axially slidable relative to the valve frame, and the motor is adapted to axially slide the at least one of plurality the anchors relative to the valve frame.

13 . The system of claim 11 , further comprising a gear system adapted to be operated by the motor to actuate movement of the at least one of the plurality of anchors.

14 . The system of claim 11 , wherein the motor is adapted to control a deflection of the at least one of the plurality of anchors relative to the valve frame.

15 . The system of claim 14 , wherein the control mechanism includes an offset controller configured to control the deflection of the at least one of the plurality of anchors relative to the valve frame simultaneously with a deflection of the at least one other anchor of the plurality of anchors with a deflection offset between the at least one of the plurality of anchors and the at least one other anchor.

16 . A system for implantation of a prosthetic valve to a native heart valve, the system comprising:
a prosthetic valve including:
a plurality of prosthetic valve leaflets,
a valve frame supporting the plurality of prosthetic valve leaflets, and
one or more anchors for anchoring the prosthetic valve to the native heart valve;
a delivery apparatus for delivering the prosthetic valve to the native heart valve, the delivery apparatus including an elongate shaft having a retention area for retaining the prosthetic valve; and one or more sutures for coupling to at least one of the anchors and for adjusting a position of the at least one anchor.

17 . The system of claim 16 , further comprising a plurality of the sutures, each suture for moving one of the anchors of the prosthetic valve radially inward independent of another anchor of the prosthetic valve.

18 . The system of claim 16 , wherein the one or more sutures are shaped to form a loop extending circumferentially around the one or more anchors.

19 . The system of claim 16 , wherein the one or more anchors each have a distal tip, at least one of the distal tips adapted to be inflated to have a greater diameter than another of the distal tips.

20 . The system of claim 16 , further comprising an inflatable body adapted to inflate radially outward from the delivery apparatus for securing the delivery apparatus in a desired position.

Assignees

• Edwards Lifesciences Corp

Inventors

• Scheinblum Taylor Jacob
• Luong Hieu Minh
• Landon David Robert
• Vad Siddharth
• Aguilar Jr Ramon
• Taylor David M
• Edwards Jesse Robert
• Dehdashtian Brandon Sina

Classifications

• A61F2220/0008

  Fixation appliances for connecting prostheses to the body · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61F2/243

  Deployment by mechanical expansion · CPC title

• A61F2/2415

  Manufacturing methods · CPC title

• A61F2/9517

  handle assemblies therefor · CPC title