Methods and apparatuses for deploying minimally-invasive heart valves

• US 9,539,091 B2
• Filed: 11/24/2015
• Issued: 01/10/2017
• 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:
  US14/951,192
• Publication Number:
  US 20160074163A1
• Time in Patent Office: 413 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 includes collapsing a prosthetic heart valve to a contracted configuration while the prosthetic heart valve is coupled to a mechanical deployment mechanism. A catheter shaft is advanced over a guidewire and through a femoral artery with the deployment mechanism and prosthetic heart valve disposed along a distal end portion thereof. The prosthetic heart valve is permitted to self-expand to an initial expanded configuration. The deployment mechanism is actuated from an operating handle to expand the prosthetic heart valve from the initial expanded configuration to a final expanded configuration. The prosthetic heart valve is locked in the final expanded configuration via a mechanical locking device located 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:

obtaining a prosthetic heart valve based on a measurement of a patient'"'"'s annulus, the 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 while coupled to a deployment mechanism;

collapsing the prosthetic heart valve to a contracted configuration while the prosthetic heart valve is coupled to the deployment mechanism;

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 the 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 the 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 contained within a tube while in the contracted configuration and is expelled from the tube for permitting the prosthetic heart valve to self-expand to the initial expanded configuration.

4. The method of claim 1, wherein the deployment mechanism comprises a plurality of proximal deployment members coupled to a 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 a 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 while connected to a deployment mechanism;

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 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;

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 the 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.