Edwards Lifesciences Corporation

Scott Hyler Heneveld, Sr

Matthew Pease

Brandon G Walsh

Jibin Yang

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.

Methods and apparatuses for deploying minimally-invasive heart valves

Methods and systems for delivering and deploying a prosthetic heart valve include a deployment mechanism coupled to the prosthetic heart valve, the deployment mechanism having a longitudinal shaft that when rotated in a first direction, expands the prosthetic heart valve from a contracted state to an expanded state, and optionally, when rotated in a second direction opposite the first direction, re-contracts the prosthetic valve from the expanded state. Embodiments of the deployment mechanism include a pinion gear that engages a gear track on the prosthetic heart valve.

A medical assembly for replacing a native heart valve of a patient. The medical assembly includes a radially expandable and collapsible prosthetic heart valve having a self-expandable stent body and a plurality of leaflet-forming membranes. The medical assembly also includes a deployment mechanism configured to deploy the prosthetic heart valve within the native heart valve of the patient. The deployment mechanism preferably includes a plurality of proximal deployment members coupled to a proximal end of the stent body. The deployment mechanism may also include a plurality of distal deployment members coupled to a distal end of the stent body. The prosthetic heart valve desirably includes a mechanical locking device configured to lock the prosthetic heart valve in a radially expanded configuration.

A method for delivering and implanting a prosthetic heart valve in a native aortic valve includes collapsing a prosthetic heart valve to a contracted configuration while the prosthetic heart valve is coupled to a mechanical deployment mechanism. A catheter shaft is advanced over a guidewire and through a femoral artery with the deployment mechanism and prosthetic heart valve disposed along a distal end portion thereof. The prosthetic heart valve is permitted to self-expand to an initial expanded configuration. The deployment mechanism is actuated from an operating handle to expand the prosthetic heart valve from the initial expanded configuration to a final expanded configuration. The prosthetic heart valve is locked in the final expanded configuration via a mechanical locking device located on the prosthetic heart valve.

A method for delivering and implanting a prosthetic heart valve in a native aortic valve is provided. The method comprises advancing the prosthetic heart valve through a patient's vasculature while the prosthetic heart valve is coupled to a mechanical deployment mechanism along a distal end portion of a catheter shaft. The prosthetic heart valve is permitted to self-expand from a contracted configuration to an initial expanded configuration. The mechanical deployment mechanism is then actuated via an operating handle to further expand the prosthetic heart valve to a fully expanded configuration while equilibrating the rate of the expansion of the proximal and distal ends of the prosthetic heart valve. The prosthetic heart valve is locked in the fully expanded configuration via a mechanical locking device disposed on the prosthetic heart valve.

Methods for deploying self-expanding heart valves

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.

A system for delivering and deploying a self-expandable heart valve includes a deployment mechanism that engages the valve and regulates the rate of expansion of both the proximal and distal ends thereof. The deployment mechanism may include a plurality of distal fingers and a plurality of proximal fingers that engage the end portions of the heart valve. Controlled radial movement of the fingers regulates the expansion of the heart valve such that the proximal and distal ends radially expand at the same rate. 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.

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Redding, CA, United States of America

Scott Hyler Heneveld, Sr