Edwards Lifesciences Corporation

Jibin Yang

Matthew Pease

Brandon G Walsh

Scott Hyler Heneveld, Sr

Scott H Heneveld

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

A method for replacing a native heart valve with a prosthetic heart valve comprises moving a first portion of a prosthetic heart valve towards a second portion of the prosthetic heart valve along a plurality of guide wires, and lock the first portion to the second portion in a final, radially expanded configuration. The prosthetic heart valve is radially contractible and expandable, and in some embodiments, is self-expanding. Embodiments of the method are minimally invasive.

Method for treating an aortic 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.

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 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 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.

Expandable, percutaneously deployable, prosthetic heart valves and systems for minimally invasive replacement of damaged or diseased native aortic valves comprise an expandable, tubular stent body and a unidirectional valve assembly. Embodiments of the stent body comprise an annulus anchoring section, a sinus section, and an outflow section, with the outflow section flared outwardly from the sinus section in an expanded configuration. Embodiments of the stent body are self-expanding, comprising, for example nitinol. The valve assembly disposed within the sinus section of the stent body and sutured thereto. Embodiments of the valve assembly comprise three leaflets, each leaflet comprising a curved outer edge sutured to the sinus section of the stent body, and a coapting free edge. Embodiments of the valve leaflets comprise pericardium, for example, porcine pericardium. Embodiments of the prosthetic heart valve have a contracted configuration dimensioned for percutaneous delivery thereof.

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.

Expandable, percutaneously deployable, prosthetic heart valves and systems for minimally invasive replacement of damaged or diseased native aortic valves comprise an expandable, tubular stent body and a unidirectional valve assembly. Embodiments of the stent body comprise an annulus anchoring section, a sinus section, and an outflow section, with the outflow section flared outward from the sinus section in an expanded configuration. Embodiments of the stent body are self-expanding, comprising, for example nitinol. The valve assembly disposed within the sinus section of the stent body and sutured thereto. Embodiments of the valve assembly comprise three leaflets, each leaflet comprising a curved outer edge sutured to the sinus section of the stent body, and a coapting free edge. Embodiments of the valve leaflets comprise pericardium. Embodiments of the prosthetic heart valve have a contracted configuration dimensioned for percutaneous delivery thereof.

Prosthetic heart valve having flared outflow section

Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. The valves are rolled into a first, contracted configuration for minimally invasive delivery and then unrolled or unfurled at the implantation site. One- and two-piece stents may be used in conjunction with a plurality of flexible leaflet-forming membranes. The one-piece stents may include an annulus anchoring section, a sinus section with the membranes attached over sinus apertures, and a rigid outflow section. The two-piece stent may include a primary stent to provide a tubular base at the annulus, and a secondary stent having the membranes that couples within the primary stent. Lockout tabs to secure the stents in their expanded shapes are provided. Also, alignment structure may be provided to ensure concentric unfurling. Anchoring barbs at the stent edges or in the stent body secure the valve within the annulus. Methods of implantation are also provided.

Two-part expandable heart valve

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.

Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. The valves are rolled into a first, contracted configuration for minimally invasive delivery using a catheter, and then unrolled or unfurled at the implantation site. One- and two-piece stents may be used in conjunction with a plurality of flexible leaflet-forming membranes. The stents may include an annulus section, a sinus section with the membranes attached over sinus apertures, and an outflow section. Lockout tabs and making slots secure the stents in their expanded shapes. Alignment structure ensures concentric unfurling of the stent. Anchoring elements at the stent edges or in the stent body secure the valve within the annulus. A method of manufacture includes shape setting the sheet-like stent to ensure an outward bias during deployment. The stent may also include dear tracks for engagement with a gear mechanism for deployment. The stent is desirably made of a superelastic material such as Nitinol and may have areas removed or thinned to reduce the bending stresses when rolled into its small spiral for catheter delivery.

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Aliso Viejo, CA, United States of America

Jibin Yang