METHODS AND APPARATUSES FOR DEPLOYING MINIMALLY-INVASIVE HEART VALVES

• US 20160074163A1
• Filed: 11/24/2015
• 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 9,539,091 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 system for delivering and deploying a self-expandable heart valve to a site of implantation such as the aortic annulus includes a deployment mechanism that engages the valve and regulates the rate of expansion of both the proximal and distal ends thereof. The heart valve may be a rolled-type valve and the deployment mechanism may include a plurality of distal fingers and a plurality of proximal fingers that engage the outer layer of the heart valve. Controlled radial movement of the fingers regulates the unwinding of the rolled heart valve. The fingers may be removed prior to inflation of a balloon to fully expand the valve, or the fingers may be repositioned to the inside of the valve for this purpose. The deployment mechanism may include an umbrella structure that forces the rolled valve outward into its fully expanded configuration. Alternatively, a gear shaft that engages one or more gear tracks on the valve may be utilized to regulate expansion of the valve. A stabilization balloon may be used to axially and radially locate the deployment mechanism relative to the site of implantation. Methods of operation of the delivery and deployment mechanism include regulating the rate of self-expansion of the valve and forcing the valve outward into its fully expanded configuration utilizing the same or different means.

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, 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;

permitting the prosthetic heart valve to self-expand to an initial expanded configuration while the deployment mechanism is coupled to the prosthetic heart valve;

actuating the deployment mechanism via the proximal operating handle to expand the prosthetic heart valve from the initial expanded configuration to a final expanded configuration;

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 advancing the catheter shaft, the deployment mechanism and the prosthetic heart valve through the femoral artery.

4. The method of claim 1, 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 plurality of proximal deployment members engage the stent body at circumferentially-spaced locations.

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

7. The method of claim 6, wherein the plurality of distal deployment members engage the stent body at circumferentially-spaced locations.

8. The method of claim 1, wherein the deployment mechanism comprises a plurality of proximal deployment members engaging the stent body at circumferentially-spaced locations and a plurality of distal deployment members engaging the stent body at circumferentially-spaced locations.

9. The method of claim 8, wherein the proximal deployment members and the distal deployment members are displaced axially toward each other for causing the prosthetic heart valve to expand from the initial expanded configuration to the final expanded configuration.

10. The method of claim 1, wherein a plurality of elongated shafts extend 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 transfer 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. 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 in an expanded configuration 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;

permitting the prosthetic heart valve to self-expand from the contracted configuration to an initial expanded configuration, wherein the deployment mechanism radially expands and remains coupled to the prosthetic heart valve while the prosthetic heart valve expands to 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;

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.

16. The method of claim 15, wherein the mechanical locking device comprises first lockout features and second lockout features, the first lockout features being spaced from the second lockout features prior to expanding the prosthetic heart valve to the final expanded configuration, and expanding the prosthetic heart valve from the initial expanded configuration to the final expanded configuration causes the first lockout features to engage the second lockout features, thereby locking the prosthetic heart valve in the final expanded configuration.

17. The method of claim 16, wherein the first lockout features comprise lockout tabs and the second lockout features comprise lockout channels, and expanding the prosthetic heart valve from the initial expanded configuration to the final expanded configuration causes the lockout tabs to engage the lockout channels, thereby locking the prosthetic heart valve in the final expanded configuration.

18. The method of claim 15, wherein the deployment mechanism comprises a plurality of proximal deployment members engaging the stent body at circumferentially-spaced locations and a plurality of distal deployment members engaging the stent body at circumferentially-spaced locations.

19. The method of claim 18, wherein the proximal deployment members and the distal deployment members are displaced axially toward each other for causing the prosthetic heart valve to expand from the initial expanded configuration to the final expanded configuration.

20. The method of claim 15, further comprising, after expanding the prosthetic heart valve from the initial expanded configuration to the final expanded configuration and before releasing the prosthetic heart valve from the deployment mechanism, actuating the deployment mechanism to compress the prosthetic heart valve, adjusting the position of the prosthetic heart valve, and actuating the deployment mechanism to re-expand the prosthetic heart valve to the final expanded configuration.