Methods for deploying self-expanding heart valves

• US 9,168,136 B2
• Filed: 05/19/2015
• Issued: 10/27/2015
• 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. Sr., Pease, Matthew L., Walsh, Brandon G.
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US14/716,011
• Publication Number:
  US 20150250588A1
• Time in Patent Office: 161 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 method for delivering and implanting a prosthetic heart valve in a native aortic valve is provided. The method comprises advancing the prosthetic heart valve through a patient'"'"'s vasculature while the prosthetic heart valve is coupled to a mechanical deployment mechanism along a distal end portion of a catheter shaft. The prosthetic heart valve is permitted to self-expand from a contracted configuration to an initial expanded configuration. The mechanical deployment mechanism is then actuated via an operating handle to further expand the prosthetic heart valve to a fully expanded configuration while equilibrating the rate of the expansion of the proximal and distal ends of the prosthetic heart valve. The prosthetic heart valve is locked in the fully expanded configuration via a mechanical locking device disposed on the prosthetic heart valve.

Claims

1. A method for delivering and implanting a prosthetic heart valve in a native aortic valve in a patient, comprising:

collapsing a prosthetic heart valve to a contracted configuration while the prosthetic heart valve is coupled to a mechanical deployment mechanism, the prosthetic heart valve comprising a self-expandable stent body and a plurality of leaflet-forming membranes made from bovine pericardium, the stent body having a proximal end and a distal end;

advancing a catheter shaft over a guidewire and through a femoral artery while a patient'"'"'s heart is beating, the catheter shaft having the deployment mechanism and prosthetic heart valve disposed along a distal end portion thereof, the catheter shaft having a proximal operating handle disposed along a proximal end portion thereof;

advancing the catheter shaft through an ascending aorta and toward a native aortic valve position while visualizing at least one radiopaque marker on the stent body;

permitting the prosthetic heart valve to self-expand to an initial expanded configuration;

actuating the deployment mechanism via the proximal operating handle for regulating a rate of expansion of the prosthetic heart valve from the initial expanded configuration to a final expanded configuration, wherein the proximal and distal ends of the stent body are expanded at equal rates, thereby allowing the stent body to maintain a generally tubular shape during expansion;

locking the prosthetic heart valve in the final expanded configuration via a mechanical locking device disposed on the prosthetic heart valve; and

detaching the deployment mechanism from the prosthetic heart valve and withdrawing the catheter shaft and deployment mechanism from a patient'"'"'s vasculature.

2. The method of claim 1, wherein the deployment mechanism is positioned inside the stent body when the prosthetic heart valve is expanded from the initial expanded configuration to the final expanded configuration.

3. The method of claim 1, wherein the prosthetic heart valve is stored with a preservative solution in a storage container while connected to the deployment mechanism and is removed from the storage container before collapsing the prosthetic heart valve to the contracted configuration.

4. The method of claim 3, wherein the deployment mechanism comprises a plurality of proximal deployment members coupled to the proximal end of the stent body.

5. The method of claim 4, wherein the deployment mechanism further comprises a plurality of distal deployment members coupled to the distal end of the stent body.

6. The method of claim 5, wherein proximal and distal ends of the deployment mechanism are displaced axially toward each other for causing the prosthetic heart valve to expand from the initial expanded configuration to the final expanded configuration.

7. The method of claim 4, wherein the plurality of proximal deployment members engages the stent body at circumferentially-spaced locations.

8. The method of claim 1, wherein the deployment mechanism further comprises a distal end cap positioned distal to the prosthetic heart valve while the catheter shaft is advanced through the femoral artery and ascending aorta, the distal end cap of the deployment mechanism being rounded for facilitating passage through the patient'"'"'s vascular system.

9. The method of claim 8, wherein the catheter shaft further comprises a distal end cap shaft fixed to the distal end cap, the distal end cap shaft having a lumen for receiving the guidewire.

10. The method of claim 1, wherein a plurality of elongated shafts extends from the proximal operating handle and through the catheter shaft for actuating the deployment mechanism.

11. The method of claim 10, wherein the plurality of elongated shafts transfers pushing and pulling forces to the deployment mechanism for regulating the rate of expansion of the prosthetic heart valve.

12. The method of claim 1, wherein the deployment mechanism is actuated by rotational torque initiated in the proximal operating handle.

13. The method of claim 1, wherein the self-expanding stent body is made from nickel-titanium.

14. The method of claim 1, wherein the mechanical locking device comprises mechanical lockout tabs.

15. The method of claim 1, wherein the stent body is spirally wound while in the contracted configuration.

16. A method for delivering and implanting a prosthetic heart valve in a native aortic valve in a patient, comprising:

providing a prosthetic heart valve comprising a self-expandable stent body and a plurality of leaflet-forming membranes made from bovine pericardium, the prosthetic heart valve stored with a preservative solution in a storage container while connected to a deployment mechanism;

removing the prosthetic heart valve from the storage container;

compressing the prosthetic heart valve to a contracted configuration;

percutaneously advancing a catheter shaft over a guidewire and through a femoral artery while a patient'"'"'s heart is beating and without cardiopulmonary bypass, the catheter shaft having the prosthetic heart valve and deployment mechanism disposed along a distal end portion thereof, the catheter shaft having a proximal operating handle disposed along a proximal end portion thereof;

while visualizing at least one radiopaque marker on the stent body, advancing the catheter shaft through an ascending aorta until the prosthetic heart valve is positioned in a native aortic valve;

permitting the prosthetic heart valve to self-expand from the contracted configuration to an initial expanded configuration;

actuating the deployment mechanism via the proximal operating handle for regulating the rate of expansion of the prosthetic heart valve from the initial expanded configuration to a final expanded configuration while equilibrating expansion along proximal and distal ends of the stent body;

locking the prosthetic heart valve in the final expanded configuration using a mechanical locking device disposed on the prosthetic heart valve; and

releasing the prosthetic heart valve from the deployment mechanism and withdrawing the catheter shaft and deployment mechanism from a patient'"'"'s vasculature.

17. The method of claim 16, wherein the deployment mechanism comprises three proximal deployment members coupled to the proximal end of the stent body.

18. The method of claim 17, wherein the deployment mechanism further comprises three distal deployment members coupled to the distal end of the stent body.

19. The method of claim 18, wherein the three proximal deployment members comprise proximal deployment pads and wherein the three distal deployment members comprise distal deployment pads.

20. The method of claim 16, wherein the deployment mechanism is positioned within the stent body while the prosthetic heart valve is expanded from the initial expanded configuration to the final expanded configuration.

21. The method of claim 16, wherein at least two elongated actuating shafts extend between the proximal operating handle and the deployment mechanism, the actuating shafts being manipulated via the proximal operating handle for actuating the deployment mechanism and regulating the rate of expansion of the prosthetic heart valve.

22. The method of claim 21, wherein proximal and distal ends of the deployment mechanism are displaced axially toward each other by manipulation of the actuating shafts, thereby causing the prosthetic heart valve to expand from the initial expanded configuration to the final expanded configuration.

23. The method of claim 21, wherein the actuating shafts transfer pushing and pulling forces to the deployment mechanism for regulating the rate of expansion of the heart valve.

24. The method of claim 21, wherein the deployment mechanism is actuated by rotational torque initiated in the proximal operating handle.

25. The method of claim 16, wherein the mechanical locking device comprises mechanical lockout tabs disposed on the prosthetic heart valve.

26. The method of claim 16, wherein the stent body is spirally wound while in the contracted configuration.