METHODS AND APPARATUSES FOR DEPLOYING MINIMALLY-INVASIVE HEART VALVES

• US 20160074157A1
• Filed: 11/23/2015
• Published: 03/17/2016
• Est. Priority Date: 09/13/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yang, Jibin, Heneveld, Scott H., Pease, Matthew L., Walsh, Brandon G.
• Granted Patent: US 9,572,664 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion

Abstract

A medical assembly for replacing a native heart valve of a patient can include a deployment mechanism and a radially expandable and contractable prosthetic heart valve coupled to the deployment mechanism. The prosthetic heart valve can comprise a self-expandable stent body and a plurality of leaflet-forming membranes. The assembly can further include a storage container, wherein the prosthetic heart valve and the deployment mechanism are disposed in the storage container.

Claims

1. A medical assembly for replacing a native heart valve of a patient, the assembly comprising:

a radially expandable and contractable prosthetic heart valve comprising a self-expandable stent body and a plurality of leaflet-forming membranes, the stent body having a proximal end and a distal end;

a deployment mechanism configured to deploy the prosthetic heart valve within the native heart valve of the patient, the prosthetic heart valve being coupled to the deployment mechanism; and

a storage container;

wherein the prosthetic heart valve and the deployment mechanism are disposed in the storage container with the prosthetic heart valve in a radially expanded state, and the prosthetic heart valve is compressible from the radially expanded state to a radially contracted state with the deployment mechanism coupled to the prosthetic heart valve.

2. The assembly of claim 1, wherein the prosthetic heart valve comprises a mechanical locking device configured to lock the prosthetic heart valve in a radially expanded configuration inside the patient.

3. The assembly of claim 2, wherein the mechanical locking device comprises mechanical lockout tabs and lockout channels, the lockout tabs configured to engage the lockout channels when the prosthetic heart valve is expanded to the radially expanded configuration.

4. The assembly of claim 1, wherein the leaflet-forming membranes are bioprosthetic leaflets and the prosthetic heart valve and the deployment mechanism are stored in a preservative solution in the storage container.

5. The assembly of claim 1, wherein the deployment mechanism is configured to be detachable from the prosthetic heart valve after the prosthetic heart valve is deployed within the native heart valve of the patient.

6. The assembly of claim 1, wherein the deployment mechanism comprises a plurality of proximal deployment members coupled to the proximal end of the stent body.

7. The assembly of claim 6, wherein the deployment mechanism further comprises a plurality of distal deployment members coupled to the distal end of the stent body.

8. The assembly of claim 6, wherein the plurality of proximal deployment members engage the stent body at circumferentially-spaced locations.

9. The assembly of claim 7, wherein the plurality of distal deployment members engage the stent body at circumferentially-spaced locations.

10. The assembly of claim 1, further comprising a proximal operating handle and a catheter shaft extending from the operating handle and having a distal end for coupling to the deployment mechanism.

11. The assembly of claim 10, further comprising a plurality of elongated shafts extending from the proximal operating handle and through the catheter shaft for actuating the deployment mechanism.

12. The assembly of claim 11, wherein the plurality of elongated shafts are configured to transfer pushing and pulling forces to the deployment mechanism for expanding the prosthetic heart valve.

13. The assembly of claim 10, wherein the deployment mechanism is actuatable by rotational torque initiated in the proximal operating handle.

14. A medical assembly for replacing a native heart valve of a patient, the assembly comprising:

a radially expandable and contractable prosthetic heart valve comprising a self-expandable stent body and a plurality of leaflet-forming membranes, the stent body having a proximal end, a distal end and a mechanical locking device configured to lock the prosthetic heart valve in a radially expanded configuration inside the patient; and

a deployment mechanism configured to deploy the prosthetic heart valve within the native heart valve of the patient, the prosthetic heart valve being coupled to the deployment mechanism;

wherein the deployment mechanism is configured to permit the prosthetic heart valve to self-expand from a radially contracted configuration to an initial radially expanded configuration while so coupled to the prosthetic heart valve and when actuated, the deployment mechanism causes the prosthetic heart valve to further expand from the initial expanded configuration to a final expanded configuration, wherein the mechanical locking device is configured to lock the prosthetic heart valve when it reaches the final expanded configuration.

15. The assembly of claim 14, further comprising a storage container, wherein the leaflet-forming membranes comprise bioprosthetic leaflets, and the prosthetic heart valve and the deployment mechanism are stored in a preservative solution in the storage container.

16. The assembly of claim 14, wherein the mechanical locking device comprises first lockout features and second lockout features, the first lockout features configured to engage the second lockout features when the prosthetic valve is expanded to the radially expanded configuration.

17. The assembly of claim 16, wherein the first lockout features comprise lockout tabs and the second lockout features comprise lockout channels, the lockout tabs configured to engage the lockout channels when the prosthetic heart valve is expanded to the radially expanded configuration.

18. The assembly of claim 14, wherein the deployment mechanism comprises a plurality of proximal deployment members and a plurality of distal deployment members, the proximal and distal deployment members being displaceable axially toward each other for causing the prosthetic heart valve to expand from the initial expanded configuration to the final expanded configuration.

19. The assembly of claim 14, wherein the deployment mechanism is configured to radially re-contract the prosthetic heart valve after self-expanding.

20. The assembly of claim 14, wherein the deployment mechanism radially expands as the prosthetic heart valve self-expands from the radially contracted configuration to the initial radially expanded configuration.