Methods and apparatuses for deploying minimally-invasive heart valves

• US 9,452,046 B2
• Filed: 01/13/2012
• Issued: 09/27/2016
• Est. Priority Date: 09/13/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Heneveld, Scott H., Yang, Jibin, Pease, Matthew L., Walsh, Brandon G.
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US13/350,730
• Publication Number:
  US 20120179243A1
• Time in Patent Office: 1,719 Days
• Field of Search: 623/1.11, 623/1.24, 623/1.26, 623/2.1, 623/2.11, 623/2.14, 623/2.17, 623/2.18, 206/339, 206/363, 206/438
• 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 replacing a diseased aortic valve includes selecting a prosthetic heart valve based on a measurement of a patient'"'"'s aortic annulus, the prosthetic heart valve stored in a storage container while in an expanded configuration. The preservative solution is drained from the storage container and the prosthetic heart valve is removed. The prosthetic heart valve is compressed to a contracted configuration and advanced through a patient'"'"'s vasculature along a distal end portion of a catheter system. The prosthetic heart valve is positioned within the diseased aortic valve and re-expanded to an initial expanded configuration. A deployment mechanism is actuated via an operating handle to further expand the prosthetic heart valve into secure engagement with surrounding tissue until lockout features on the prosthetic heart valve secure the prosthetic heart valve in a final expanded configuration.

Claims

1. A method for replacing a diseased aortic valve with a prosthetic heart valve in a patient, comprising:

selecting a prosthetic heart valve based on a measurement of the patient'"'"'s aortic annulus, the prosthetic heart valve comprising a stent body and a plurality of leaflet-forming membranes made from bovine pericardium, the prosthetic heart valve stored in a preservative solution inside a storage container while in an expanded configuration;

draining the preservative solution from the storage container;

removing the prosthetic heart valve from the storage container;

compressing the prosthetic heart valve to a contracted configuration;

advancing the prosthetic heart valve through a femoral artery and ascending aorta while the patient'"'"'s heart is beating, the prosthetic heart valve held in the contracted configuration by a deployment mechanism while positioned along a distal end of a catheter system, the deployment mechanism comprising a plurality of proximal deployment members for engaging a proximal portion of the stent body and a plurality of distal deployment members for engaging a distal portion of the stent body, the proximal and distal deployment members engaging the stent body at circumferentially-spaced locations on a periphery thereof, the catheter system having a catheter shaft and an actuating shaft extending through a lumen of the catheter shaft for actuating the deployment mechanism;

advancing the prosthetic heart valve to the diseased aortic valve while visualizing at least one radiopaque marker on the stent body;

re-expanding the prosthetic heart valve to an initial expanded configuration, wherein the actuating shaft is manipulated via an operating handle for causing the deployment mechanism to regulate the rate of expansion such that the proximal and distal end portions of the stent body expand at the same rate;

further expanding the prosthetic heart valve into engagement with surrounding tissue until lockout features on the prosthetic heart valve secure the prosthetic heart valve in a final expanded configuration; and

releasing the deployment mechanism from the prosthetic heart valve and withdrawing the catheter system from the patient'"'"'s vasculature;

wherein, after deployment, the prosthetic heart valve replaces the diseased aortic valve and restores valvular function.

2. The method of claim 1, wherein the catheter system includes a guidewire lumen for receiving a guidewire.

3. The method of claim 1, wherein a balloon is expanded within the prosthetic heart valve for assisting with expansion to the final expanded configuration.

4. The method of claim 1, wherein the stent body is self-expanding.

5. The method of claim 4, wherein the stent body is formed of Nitinol.

6. The method of claim 1, wherein the lockout features on the prosthetic heart valve comprise mechanical tabs.

7. A method for replacing a diseased aortic valve and restoring valvular function, comprising:

selecting a prosthetic heart valve based on a measurement of the patient'"'"'s aortic annulus, the prosthetic heart valve comprising a stent body and a plurality of leaflet-forming membranes made from bovine pericardium, the prosthetic heart valve stored in a storage container while in an expanded configuration;

draining a preservative solution from the storage container and rinsing the prosthetic heart valve;

removing the prosthetic heart valve from the storage container;

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

advancing the prosthetic heart valve over a guidewire and through a patient'"'"'s vasculature while the prosthetic heart valve and deployment mechanism are positioned along a distal end portion of a catheter system;

positioning the prosthetic heart valve within the diseased aortic valve;

controlling re-expansion of the prosthetic heart valve to an initial expanded configuration;

actuating the deployment mechanism to further expand the prosthetic heart valve into secure engagement with surrounding tissue until lockout features on the prosthetic heart valve secure the prosthetic heart valve in a final expanded configuration; and

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

8. The method of claim 7, wherein the catheter system includes a plurality of control shafts axially movable with respect to each other.

9. The method of claim 8, wherein the control shafts cooperate with at least three fingers of the deployment mechanism, the fingers engaging the prosthetic heart valve at circumferentially-spaced locations on a periphery thereof.

10. The method of claim 9, wherein the prosthetic heart valve further comprises at least one radiopaque marker.

11. The method of claim 10, wherein the stent body is formed of Nitinol.

12. A method for replacing a diseased aortic valve and restoring valvular function, comprising:

selecting a prosthetic heart valve based on a measurement of the patient'"'"'s aortic annulus, the prosthetic heart valve comprising a stent body and a plurality of leaflet-forming membranes made from bovine pericardium, the prosthetic heart valve stored in a preservative solution in a storage container while in an expanded configuration;

draining the preservative solution from the storage container;

removing the prosthetic heart valve from the storage container;

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

advancing the prosthetic heart valve over a guidewire and through a patient'"'"'s vasculature while the patient'"'"'s heart is beating, the prosthetic heart valve and deployment mechanism disposed along a distal end portion of a catheter system, the stent body maintained in a contracted configuration during advancement;

positioning the prosthetic heart valve within the diseased aortic valve;

controlling re-expansion of the prosthetic heart valve to an initial expanded configuration;

actuating the deployment mechanism for further expanding the prosthetic heart valve into secure engagement with surrounding tissue until lockout features on the prosthetic heart valve secure the prosthetic heart valve in a final expanded configuration; and

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

13. The method of claim 12, wherein the catheter system includes a plurality of control shafts axially movable with respect to each other.

14. The method of claim 13, wherein the control shafts cooperate with at least three fingers of the deployment mechanism, the fingers engaging the prosthetic heart valve at circumferentially-spaced locations on a periphery thereof.