Method and Apparatuses for Deploying Minimally-Invasive Heart Valves

• US 20090254177A1
• Filed: 06/19/2009
• Published: 10/08/2009
• Est. Priority Date: 09/13/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Heneveld, Scott Hyler SR., Walsh, Brandon G., Yang, Jibin, Pease, Matthew Lane
• Granted Patent: US 8,740,975 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 head 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 of delivering a prosthetic heart valve comprising a radially self-expandable valve body, the method comprising:

introducing the heart valve into a patient'"'"'s body with the valve body in a radially compressed state;

allowing the valve body to self-expand from the radially compressed state to an initial expanded state; and

applying an expansion force to the valve body to further expand the valve body from the initial expanded state to a final expanded state.

2. The method of claim 1, wherein applying an expansion force to the valve body comprises inflating a balloon positioned inside the valve body to expand the valve body from the initial expanded state to the final expanded state.

3. The method of claim 2, wherein prior to inflating the balloon and subsequent to allowing the valve body to self-expand to the initial expanded state, moving the balloon from a position outside of the valve body to a position inside the valve body.

4. The method of claim 1, wherein applying an expansion force to the valve body comprises applying a non-hydraulic and non-pneumatic expansion force on the valve body to further expand the valve body from the initial expanded state to the final expanded state.

5. The method of claim 4, wherein applying a non-hydraulic and non-pneumatic expansion force comprises applying an axially directed force on a deployment mechanism, which causes the valve body to further expand from the initial expanded state to the final expanded state.

6. The method of claim 5, wherein applying an axially directed force on a deployment mechanism comprises moving a shaft of the deployment mechanism axially relative to the valve body to effect expansion of the valve body from the initial expanded state to the final expanded state.

7. The method of claim 1, wherein expansion of the valve body from the initial expanded state to the final expanded state causes a first lockout element on the valve body to engage a second lockout element on the valve body to maintain the valve body in the final expanded state.

8. A method of delivering a prosthetic heart valve comprising a radially expandable valve body, the method comprising:

introducing the heart valve into a catheter and advancing the heart valve outwardly from the distal end of the catheter into the vasculature of a patient; and

after the heart valve has been advanced from the distal end of the catheter, radially expanding the valve body by applying an axially directed actuation force to a deployment mechanism, which forces the valve body to radially expand.

9. The method of claim 8, further comprising allowing the valve body to self-expand to a partially expanded configuration outside of the catheter before expanding the valve body by applying the axially directed actuation force to the deployment mechanism.

10. The method of claim 8, wherein applying the axially directed actuation force does not comprise expanding a balloon.

11. The method of claim 8, wherein radially expanding the valve body causes a first lockout element on the valve body to engage a second lockout element on the valve body to maintain the valve body in a radially expanded state.

12. The method of claim 8, wherein applying the axially directed actuation force comprises moving a shaft of the deployment mechanism axially relative to the valve body to effect expansion of the valve body.

13. A method of delivering a prosthetic heart valve comprising:

introducing the heart valve into a catheter and advancing the heart valve outwardly from the distal end of the catheter into the vasculature of a patient;

subsequent to advancing the heart valve outwardly from the catheter, partially radially expanding the heart valve from a compressed state to a first expanded state and adjusting the position of a balloon relative to the heart valve from a first location outside of the heart valve to a second position extending at least partially through the heart valve; and

inflating the balloon to further expand the heart valve from the first expanded state to a second expanded state having a diameter greater than the first expanded state.

14. The method of claim 13, wherein the heart valve comprises a plastically-deformable heart valve.

15. The method of claim 13, wherein the heart valve comprises a self-expandable heart valve.

16. The method of claim 13, wherein the first expanded state of the heart valve is large enough to receive the balloon but does not engage surrounding tissue.