METHODS AND APPARATUSES FOR DEPLOYING MINIMALLY-INVASIVE HEART VALVES

• US 20160151152A1
• Filed: 02/05/2016
• Published: 06/02/2016
• 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 9,848,985 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 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.

Claims

1. A method of deploying a prosthetic heart valve, comprising:

advancing a catheter shaft into a patient'"'"'s body, the catheter shaft having a deployment mechanism and a prosthetic heart valve disposed along a distal end portion thereof, the prosthetic heart valve comprising an expandable stent body and a plurality of leaflet-forming membranes, the prosthetic heart valve releasably coupled to the deployment mechanism;

expanding the prosthetic heart valve from a fully contracted configuration to an initial expanded configuration and into contact with surrounding tissue at an implantation site in the patient'"'"'s body;

contracting the prosthetic heart valve from the initial expanded configuration to a partially contracted configuration by actuating the deployment mechanism;

modifying a position of the prosthetic heart valve relative to the implantation site; and

expanding the prosthetic heart valve from the partially contracted configuration to a fully expanded configuration by actuating the deployment mechanism;

wherein the stent body has an outer diameter in the fully expanded configuration that is greater than an outer diameter in the initial expanded configuration.

2. The method of claim 1, further comprising locking the prosthetic heart valve in the fully expanded configuration.

3. The method of claim 1, further comprising releasing the prosthetic heart valve from the distal end of the catheter shaft by disengaging the deployment mechanism from the prosthetic heart valve.

4. The method of claim 3, wherein disengaging the deployment mechanism includes rotating a handle disposed outside of the patient'"'"'s body.

5. The method of claim 2, further comprising actuating a mechanical lockout element on the stent body for maintaining the prosthetic heart valve in the fully expanded configuration.

6. The method of claim 1, wherein actuating the deployment mechanism to contract the prosthetic heart valve from the initial expanded configuration to the partially contracted configuration includes rotating a handle disposed outside of the patient'"'"'s body in a first direction, and actuating the deployment mechanism to expand the prosthetic heart valve from the partially contracted configuration to a fully expanded configuration includes rotating the handle in a second direction which is opposite the first direction.

7. The method of claim 1, wherein the implantation site is a native aortic valve.

8. The method of claim 1, wherein advancing the catheter shaft into a patient'"'"'s body includes advancing the catheter shaft over a guidewire.

9. The method of claim 1, further comprising regulating the expansion of the prosthetic heart valve with the deployment mechanism.

10. A method of deploying a prosthetic heart valve, comprising:

introducing a prosthetic heart valve and a deployment mechanism into a patient'"'"'s vasculature, the prosthetic heart valve being releasably coupled to a deployment mechanism, and the deployment mechanism being coupled to a distal end portion of a catheter shaft;

percutaneously advancing the distal end portion of the catheter shaft, along with the prosthetic heart valve and the deployment mechanism, through the patient'"'"'s vasculature;

positioning the prosthetic heart valve at a first position at an implantation site;

expanding the prosthetic heart valve from a fully contracted configuration at least to an initial expanded configuration such that the prosthetic heart valve contacts surrounding tissue at the first position;

contracting the prosthetic heart valve from the initial expanded configuration to a partially contracted configuration greater than the fully contracted configuration;

repositioning the prosthetic heart valve by moving the prosthetic heart valve from the first position within the patient'"'"'s body to a second position at the implantation site while the prosthetic heart valve is in the partially contracted configuration; and

expanding the prosthetic heart valve from the partially contracted configuration to a fully expanded configuration greater than the initial expanded configuration such that the prosthetic heart valve contacts surrounding tissue at the second position.

11. The method of claim 10, further comprising locking the prosthetic heart valve in the fully expanded configuration by actuating the deployment mechanism.

12. The method of claim 10, further comprising releasing the prosthetic heart valve from the deployment mechanism.

13. The method of claim 10, wherein positioning the prosthetic heart valve includes expelling the prosthetic heart valve from a tube inserted into the patient'"'"'s body.

14. The method of claim 10, wherein contracting the prosthetic heart valve from the initial expanded configuration to the partially contracted configuration and expanding the prosthetic heart valve from the partially contracted configuration to the fully expanded configuration include actuating the deployment mechanism.

15. The method of claim 10, wherein repositioning the prosthetic heart valve includes moving a handle disposed outside of the patient'"'"'s body axially relative to a tube inserted into the patient'"'"'s body.

16. The method of claim 10, further comprising:

contracting the prosthetic heart valve from the fully expanded configuration to the fully contracted configuration by actuating the deployment mechanism; and

retrieving the prosthetic heart valve from the patient'"'"'s body while the prosthetic heart valve is in the fully contracted configuration.

17. The method of claim 16, wherein retrieving the prosthetic heart valve from the patient'"'"'s body includes retracting the prosthetic heart valve back into a tube inserted into the patient'"'"'s body which occurs after contracting the prosthetic heart valve from the expanded configuration to the fully contracted configuration.

18. A method of deploying a prosthetic heart valve, comprising:

percutaneously advancing a distal end portion of a catheter shaft, a prosthetic heart valve, and a deployment mechanism through a patient'"'"'s vasculature, the deployment mechanism being coupled to the distal end portion of the catheter shaft, and the prosthetic heart valve being releasably coupled to the deployment mechanism;

positioning the prosthetic heart valve at an implantation site;

expanding the prosthetic heart valve from a fully contracted configuration to an expanded configuration contacting surrounding tissue at the implantation site by actuating the deployment mechanism;

contracting the prosthetic heart valve from the expanded configuration to a fully contracted configuration by actuating the deployment mechanism; and

retrieving the prosthetic heart valve from the patient'"'"'s body while the prosthetic heart valve is in the fully contracted configuration.

19. The method of claim 18, further comprising retracting the prosthetic heart valve back into a tube inserted into the patient'"'"'s body after contracting the prosthetic heart valve from the expanded configuration to the fully contracted configuration.

20. The method of claim 18, further comprising repositioning the prosthetic heart valve from a first position at the implantation site to a second position at the implantation site prior to the act of retrieving the prosthetic heart valve.

21. The method of claim 18, wherein positioning the prosthetic heart valve includes expelling the prosthetic heart valve and the deployment mechanism from a tube inserted into the patient'"'"'s body.

22. The method of claim 18, wherein the expanded configuration of the prosthetic heart valve is an initial expanded configuration less than a fully expanded configuration.

23. The method of claim 18, further comprising regulating the expansion of the prosthetic heart valve with the deployment mechanism.