Edwards Lifesciences Corporation

Mitral Valve Technologies Sarl

Mark Chau

Travis Zenyo Oba

Seung-Beom Yi

Stephen C Geist

Qinggang Zeng

Rafael Pintor

August R Yambao

Tammy Huntley

Marlowe E Patterson

Louis A Campbell

Faisal Kalam

Carey L Cristea

Alexander J Siegel

Robert C Taft

Stanton J Rowe

Kevin M Golemo

Paul A Spence

Son V Nguyen

Landon H Tompkins

Sergio Delgado

Sam Sok

Matthew A Peterson

David Mark Taylor

Alexander H Cooper

Bao Khuu

Eric Robert Dixon

Asher L Metchik

Matthew T Winston

Lauren R Freschauf

Emil Karapetian

Christopher J Olson

Cristobal R Hernandez

David Leigh Hauser

Yoon Hee Kwon

Michael J Popp

Jane M Olin

Quinggang Zeng

Steve Geist

Philip Corso

Alex Siegel

V Nguyen Son

Phillip Corso

A system for replacing a native valve of the heart includes a delivery apparatus having a sheath and a prosthetic valve. The prosthetic valve includes a frame having an annular main body, a plurality of ventricular anchors attached to the main body, an atrial anchor attached to an atrial end portion of the main body, and a valve structure disposed within the main body of the frame. The prosthetic valve is disposed within a distal end portion of the sheath in a compressed, delivery state. When the prosthetic valve is deployed from the sheath, the main body of the frame radially expands to a radially expanded state, the ventricular anchors expand to a deployed state alongside the main body of the frame for capturing native leaflets of the native valve, and the atrial anchor expands to a deployed state extending radially outwardly from the main body.

System for replacing a native valve of the heart

A prosthetic heart valve includes a multi-part frame having a first annular body and an anchor component that includes a second annular body circumscribing the first annular body. The first annular body includes a plurality of struts arranged in a lattice pattern and defining a lumen. The anchor component further includes one or more ventricular anchors extending from the second annular body toward an inflow end portion of the first annular body. A fabric layer is disposed on an inner surface of the first annular body and sutured to the struts. A valve structure including three leaflets is disposed within the lumen and inlet ends of the leaflets are sutured to the fabric layer. The multi-part frame is radially compressible for delivery within a sheath of a delivery catheter and is self-expandable for deployment within an annulus of a native valve.

Prosthetic valve having a multi-part frame

A method of implanting a prosthetic heart valve assembly includes advancing a delivery catheter through a vein and toward a native heart valve. The prosthetic heart valve assembly is deployed from a lumen of the delivery catheter, allowing the prosthetic heart valve assembly to self-expand from a compressed state to a functional size within an annulus of the native heart valve with a flared upper portion of the stent located in an atrium against a supra-annular surface of the annulus of the native heart valve. An elongate anchoring member is attached to a septum of a ventricle at a location below the annulus. The flared upper portion contacts a supra-annular surface of the native heart valve for preventing downward migration of the prosthetic heart valve assembly toward the ventricle and the elongate anchoring member prevents upward migration of the prosthetic heart valve assembly toward the atrium.

Method of implanting a prosthetic heart valve assembly

A method for heart valve replacement comprises forming an incision in a wall of a ventricle of a heart and inserting a delivery apparatus and a prosthetic heart valve through the incision and into the ventricle of the heart. The prosthetic valve comprises a self-expanding frame having an annular main body and a valve member disposed within the annular main body. The prosthetic valve further comprises an atrial sealing member formed by an annular metal ring and a fabric, wherein only the fabric of the atrial sealing member is connected to the main body for enhancing the flexibility and conformability of the atrial sealing member. The method further comprises deploying the prosthetic valve from the delivery apparatus such that the atrial sealing member extends radially outwardly from the main body within an atrium of the heart and the main body self-expands to a deployed state within a native heart valve.

Prosthetic heart valve with atrial sealing member

A prosthetic device includes a main body, a first anchor, a second anchor, a first anchor spreader, and a second anchor spreader. The first anchor is coupled to the main body such that a spring force of the first anchor biases the first anchor toward the main body. The second anchor is coupled to the main body such that a spring force of the second anchor biases the second anchor against the main body. The first anchor spreader is coupled to the first anchor such that applying a force to the first anchor spreader moves the first anchor away from the main body against the spring force of the first anchor. The second anchor spreader is coupled to the second anchor such that applying a force to the second anchor spreader moves the second anchor away from the main body against the spring force of the second anchor.

Method of implanting a spacer body in a mitral valve

A prosthetic heart valve assembly includes a self-expandable stent having a flared upper portion, a lower portion, and an intermediate portion extending from the upper portion to the lower portion. The stent includes upwardly bent hooks extending from an outer surface of the stent, which are adapted to engage native leaflet tissue. The stent further includes an elongate anchoring member extending from the lower portion of the stent, which is adapted to be secured to a ventricle wall via a prong portion. When deployed within the native heart valve, the flared upper portion contacts a supra-annular surface of the native heart valve for preventing downward migration of the prosthetic heart valve assembly toward the ventricle and the upwardly bent hooks and the elongate anchoring member prevent upward migration of the prosthetic heart valve assembly toward an atrium.

Prosthetic heart valve assembly

A prosthetic heart valve for implantation at a native heart valve includes a multi-part frame. The multi-part frame includes a cylindrical main body and a ventricular anchor component surrounding the main body. The main body includes a plurality of struts arranged in a lattice pattern. The ventricular anchor component is attached to the main body only at an outflow end of the main body and extends toward an inflow end of the main body. The prosthetic valve further includes a valve structure having three leaflets made from pericardium. The multi-part frame is radially compressible for delivery within a sheath of a delivery catheter and is self-expandable for deployment within an annulus of the native valve. The main body and the ventricular anchor component are formed separately and are attached by a locking mechanism for reducing strain between the main body and the ventricular anchor component.

Prosthetic valve having multi-part frame

A method of implanting a prosthetic apparatus preferably includes delivering the prosthetic apparatus to a native mitral valve and exposing ventricular anchors and a spacer body of the prosthetic apparatus from a distal end portion of a delivery apparatus. The ventricular anchors are controllably and forcibly expanded outwardly from the spacer body to an expanded configuration. The prosthetic apparatus is positioned relative to the native mitral valve such that native mitral valve leaflets are located between the ventricular anchors and the spacer body. The ventricular anchors are then contracted radially inwardly toward the spacer body to a compressed configuration. In the compressed configuration, the native mitral valve leaflets are secured between the ventricular anchors and the spacer body. After implantation, the spacer body is held between the native mitral valve leaflets, thereby blocking regurgitation and improving the function of the native mitral valve.

An anchor for a prosthetic heart valve includes a core, a first cover layer, and a second cover layer. The core includes a plurality of helical turns. One or more outflow turns of the plurality of helical turns has a diameter configured to be disposed on an outflow side of a native valve, and one or more inflow turns of the plurality of helical turns has a diameter configured to be disposed on an inflow side of a native valve. The first cover layer is disposed over and contacts the helical core, and the first cover layer includes a first material. The second cover layer is disposed over and contacts the first cover layer, and the second cover layer includes a second material, which is different than the first material.

Coiled anchor for supporting prosthetic heart valve, prosthetic heart valve, and deployment device

In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion. The prosthetic device can be movable between multiple configurations. The spacer body can be configured to extend radially outwardly as the spacer body extends away from the distal end toward the proximal end. A delivery apparatus can have a first shaft and a second shaft, wherein movement of the first shaft relative to the second shaft moves the anchor portion relative to the spacer body.

Heart valve sealing devices and delivery devices therefor

A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve has a base stent that is deployed at a treatment site, and a valve component configured to quickly connect to the base stent. The base stent may take the form of a self- or balloon-expandable stent that expands outward against the native valve with or without leaflet excision. The valve component has a non-expandable prosthetic valve and a self- or balloon-expandable coupling stent for attachment to the base stent, thereby fixing the position of the valve component relative to the base stent. The prosthetic valve may be a commercially available to valve with a sewing ring and the coupling stent attaches to the sewing ring. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment. A catheter-based system and method for deployment is provided.

Rapid implant prosthetic heart valve system

A prosthetic spacer assembly includes a spacer body, a first anchor, and a second anchor. The first anchor and the second anchor are each connected to the spacer body. The first anchor is configured to capture a first native valve leaflet between the first anchor and the spacer body. The second anchor is configured to capture a second native valve leaflet between the second anchor and the spacer body. When inside a delivery sheath, the first anchor and the second anchor can extend distally from the spacer body.

Valve repair and replacement devices

In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion. The prosthetic device can be movable between multiple configurations. The spacer body can be made from braided, self-expandable metallic thread. A delivery apparatus can have a first shaft and a second shaft, wherein movement of the first shaft relative to the second shaft moves the anchor portion relative to the spacer body.

A prosthetic heart valve assembly includes a self-expandable stent having an inlet end and an outlet end and a passageway extending therethrough. The stent includes a plurality of rows of prongs on the outer surface of the stent. A valve portion comprising a plurality of leaflets is positioned within the passageway for permitting blood to flow through the passageway from the inlet end to the outlet end while blocking flow in the opposite direction. The stent further includes a flared upper portion shaped for placement along a supra-annular surface of an annulus for preventing downward migration of the prosthetic valve assembly into a ventricle. Each of the prongs has a tip pointing toward the inlet end for penetrating surrounding tissue and preventing upward migration of the prosthetic heart valve assembly toward an atrium.

A prosthetic spacer assembly includes a spacer body, a first anchor, and a second anchor. The first anchor and the second anchor are each connected to the spacer body. The first anchor is configured to capture a first native valve leaflet between the first anchor and the spacer body. The second anchor is configured to capture a second native valve leaflet between the second anchor and the spacer body.

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Aliso Viejo, CA, United States of America

Mark Chau