Methods and apparatuses for deploying minimally-invasive heart valves

• US 8,740,975 B2
• Filed: 06/19/2009
• Issued: 06/03/2014
• Est. Priority Date: 09/13/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yang, Jibin, Pease, Matthew Lane, Heneveld, Scott Hyler Sr., Walsh, Brandon G.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Prone, Christopher D
• Application Number:
  US12/488,480
• Publication Number:
  US 20090254177A1
• Time in Patent Office: 1,810 Days
• Field of Search: 623 124- 126, 623/2.11, 623/2.13, 623/2.14, 623/2.17, 623/1.11, 623/2.1, 606/108, 606/191, 606/192, 606/194, 606/198
• US Class Current: 623/2.11
• 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 deploying a self-expandable heart valve to a site of implantation such as the aortic annulus. The deployment step may include engaging an outer surface of the heart valve with a plurality of distal fingers and a plurality of proximal fingers. Controlled radial movement of the fingers regulates the expansion of the 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 step may include an umbrella structure that forces the 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.

Claims

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

providing a prosthetic heart valve comprising a radially self-expandable valve body made of a nickel-titanium alloy and leaflets made from pericardium, each leaflet comprising a curvilinear edge sutured to the valve body;

securing the heart valve to a plurality of deployment members disposed on a distal end portion of an elongate catheter, the deployment members protruding radially outward through a plurality of rectangular openings along a proximal end portion of the valve body;

introducing the distal end portion of the catheter and heart valve secured thereto into a patient'"'"'s body with the valve body in a radially compressed state, the distal end portion of the catheter comprising a nose that facilitates introduction into and passage through a vascular system;

allowing the valve body to self-expand from the radially compressed state to an initial expanded state while the valve body is positioned at least partially within a native heart valve annulus;

moving a balloon from a position outside of the valve body to a position inside the valve body after allowing the valve body to self-expand; and

inflating the balloon inside the valve body to further expand the valve body from the initial expanded state to a final expanded state after detaching the heart valve from the plurality of deployment members.

2. 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.

3. The method of claim 1, wherein providing the prosthetic heart valve comprises providing a prosthetic heart valve comprising leaflets made from bovine pericardium.

4. The method of claim 1, wherein the nose is rounded and bullet-shaped.

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

providing a prosthetic heart valve comprising a radially self-expandable valve body made of a nickel-titanium alloy and leaflets made from pericardium;

securing the heart valve to a plurality of deployment members that protrude radially outward through a plurality of rectangular openings along a proximal end portion of the valve body;

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

detaching the heart valve from the plurality of deployment members; and

after the heart valve has been detached from the plurality of deployment members, radially expanding the valve body by inflating a balloon disposed therein, which forces the valve body to radially expand and to contact tissue near a native heart valve annulus.

6. The method of claim 5, further comprising allowing the valve body to self-expand to a partially expanded configuration outside of the catheter before expanding the valve body by inflating the balloon disposed therein.

7. The method of claim 5, 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.

8. The method of claim 5, wherein providing the prosthetic heart valve comprises providing a prosthetic heart valve comprising leaflets made from bovine pericardium.

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

providing a collapsible and expandable prosthetic heart valve comprising a radially self-expanding valve body made of a nickel-titanium alloy and leaflets made from pericardium;

securing the heart valve to a deployment mechanism, the deployment mechanism including spaced apart proximal and distal deployment members for regulating a self-expansion of the prosthetic heart valve, the proximal deployment members configured to engage an outer surface of a proximal end portion of the valve body for applying a radially inward force along the proximal end portion of the valve body, and the distal deployment members configured to engage an outer surface of a distal end portion of the valve body for applying a radially inward force along the distal end portion of the valve body;

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

regulating the self expansion of the heart valve from a compressed state to a first expanded state;

detaching the heart valve from the deployment mechanism;

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 after regulating the self expansion of the heart valve from the compressed state to the first expanded state; 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 after detaching the heart valve from the deployment mechanism.

10. The method of claim 9, wherein the heart valve comprises a plastically-deformable heart valve.

11. The method of claim 9, wherein the first expanded state of the heart valve is large enough to receive the balloon but does not engage surrounding tissue.

12. The method of claim 9, wherein providing the collapsible and expandable prosthetic heart valve comprises providing a collapsible and expandable prosthetic heart valve comprising leaflets made from bovine pericardium.

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

securing a prosthetic heart valve in a radially compressed state to a deployment system,

the prosthetic heart valve comprising a self-expanding, nitinol, tubular valve body, a plurality of valve leaflets coupled to the valve body, and a plurality of openings disposed at a proximal end portion of the valve body, the heart valve having a relaxed diameter,

the deployment system comprising an elongate catheter having a plurality of deployment members disposed on a distal portion thereof, at least a portion of each deployment member extending radially outward through each opening in the valve body, thereby securing the prosthetic heart valve to the deployment system, a distal end of the elongate catheter further comprising a nose that facilitates introduction into and passage through a patient'"'"'s vasculature;

advancing the radially compressed prosthetic heart valve through a patient'"'"'s vasculature to a position at least partially within a native heart valve annulus, the native heart valve annulus having a diameter smaller than the relaxed diameter of the prosthetic heart valve;

allowing the valve body to self-expand from the radially compressed state to a partially expanded state contacting native heart valve tissue;

introducing a balloon into the valve body in the partially expanded state;

detaching the prosthetic heart valve from the plurality of deployment members; and

expanding the valve body using the balloon to a final diameter larger than the diameter of the native heart valve annulus, thereby securely engaging the prosthetic heart valve to the native heart valve.

14. The method of claim 13, further comprising positioning the balloon within the valve body with the prosthetic heart valve in the partially expanded state.

15. The method of claim 13, wherein securing the prosthetic heart valve comprises securing a prosthetic heart valve comprising a plurality of pericardium valve leaflets.