Methods and apparatuses for deploying minimally-invasive heart valves

• US 9,848,985 B2
• Filed: 02/05/2016
• Issued: 12/26/2017
• Est. Priority Date: 09/13/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yang, Jibin, Heneveld, Sr., Scott H., Pease, Matthew L., Walsh, Brandon G.
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US15/017,177
• Publication Number:
  US 20160151152A1
• Time in Patent Office: 690 Days
• 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 made from a nickel-titanium alloy and a plurality of leaflet-forming membranes made from pericardium, the prosthetic heart valve releasably coupled to the deployment mechanism, the prosthetic heart valve positioned within an outer tube during advancement into the patient'"'"'s body, the deployment mechanism comprising an actuation shaft and a plurality of retaining bars for retaining the stent body relative to the catheter shaft, wherein the actuation shaft is movable relative to the retaining bars for applying expansion and contraction forces to the stent body;

advancing the catheter shaft relative to the outer tube for expelling the prosthetic heart valve from the outer tube;

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 moving the actuation shaft relative to the retaining bars for applying a contraction force to the stent body while the prosthetic heart valve remains expelled from the outer tube;

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 moving the actuation shaft relative to the retaining bars for applying an expansion force to the stent body, the stent body having an outer diameter in the fully expanded configuration that is greater than an outer diameter in the initial expanded configuration;

wherein proximal and distal end portions of the stent body remain rotationally fixed relative to the catheter shaft while expanding and contracting the prosthetic heart valve.

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

3. 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.

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

5. The method of claim 4, wherein disengaging the deployment mechanism includes rotating a handle about a longitudinal axis of the catheter shaft.

6. The method of claim 1, wherein moving the actuation shaft 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 moving the actuation shaft 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, wherein the handle is rotated about a longitudinal axis of the catheter shaft.

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 comprising an expandable stent body made from a nickel-titanium alloy and a plurality of leaflet-forming membranes made from pericardium, 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, the deployment mechanism including a plurality of retaining bars for maintaining at least a portion of the stent body rotationally fixed relative to the 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, the prosthetic heart valve positioned within an outer tube during advancement for maintaining the prosthetic heart valve in a contracted configuration;

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

expelling the prosthetic heart valve from the outer tube such that the entire prosthetic heart valve is positioned distal to a distal end of the outer tube;

expanding the prosthetic heart valve from the 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 via actuation of the deployment mechanism, wherein the contraction occurs while the prosthetic heart valve remains positioned distal to the distal end of the outer tube;

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;

wherein proximal and distal end portions of the stent body are rotationally fixed relative to the catheter shaft while expanding and contracting the prosthetic heart valve.

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 the plurality of retaining bars comprises proximal and distal retaining bars coupled to proximal and distal end portions of the stent.

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 via a rotatable handle.

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 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 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 the outer tube after contracting the prosthetic heart valve from the expanded configuration to the 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 via a plurality of metallic retaining components, the prosthetic heart valve positioned within an outer tube during advancement for maintaining the prosthetic heart valve in a contracted configuration;

positioning the prosthetic heart valve at an implantation site;

expelling the prosthetic heart valve from the outer tube;

while the prosthetic heart valve is distal to the outer tube, controllably expanding the prosthetic heart valve to an expanded configuration 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;

wherein proximal and distal end portions of the prosthetic heart valve are rotationally fixed relative to the catheter shaft while expanding and contracting the prosthetic heart valve.

19. The method of claim 18, further comprising retracting the prosthetic heart valve back into the outer tube 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 the expanded configuration of the prosthetic heart valve is an initial expanded configuration less than a fully expanded configuration.

22. The method of claim 18, further comprising regulating the expansion of the prosthetic heart valve with the deployment mechanism via actuation of the metallic retaining components.