METHODS AND APPARATUSES FOR DEPLOYING MINIMALLY-INVASIVE HEART VALVES

摘要

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 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.

主权项

1. A method for delivering and implanting a prosthetic heart valve in a native aortic valve in a patient, comprising:
collapsing a prosthetic heart valve to a contracted configuration while the prosthetic heart valve is coupled to a mechanical deployment mechanism, the prosthetic heart valve comprising a self-expandable stent body and a plurality of leaflet-forming membranes, the stent body having a proximal end and a distal end; advancing a catheter shaft over a guidewire and through a femoral artery while a patient's heart is beating, the catheter shaft having the deployment mechanism and prosthetic heart valve disposed along a distal end portion thereof, the catheter shaft having a proximal operating handle disposed along a proximal end portion thereof; permitting the prosthetic heart valve to self-expand to an initial expanded configuration while the deployment mechanism is coupled to the prosthetic heart valve; actuating the deployment mechanism via the proximal operating handle to expand the prosthetic heart valve from the initial expanded configuration to a final expanded configuration; locking the prosthetic heart valve in the final expanded configuration via a mechanical locking device disposed on the prosthetic heart valve; and detaching the deployment mechanism from the prosthetic heart valve and withdrawing the catheter shaft and deployment mechanism from a patient's vasculature.