Edwards Lifesciences Corporation

Stephen C Geist

Travis Zenyo Oba

Mark Chau

Seung-Beom Yi

Marlowe E Patterson

Robert C Taft

Sam Sok

Matthew A Peterson

Kevin M Golemo

David Leigh Hauser

Joseph Arthur Passman

Minh T Ma

C Roger Ekholm

Rohan Yogee Katbamna

Aric Daniel Stone

Timothy Allen Dalton

Jose Islas

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 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 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.

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

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.

Ventricular anchors for valve repair and replacement devices

A prosthetic apparatus for implantation in a native heart valve includes a main body for placement within the native annulus. The main body is compressible to a radially compressed state for delivery into the heart and is self-expandable from the compressed state to a radially expanded state for implantation. A valve structure is mounted within a lumen of the main body and preferably forms three leaflets made of pericardium. Ventricular anchors are coupled to a ventricular end portion of the main body. The ventricular anchors are adapted to be straightened for delivery to the native heart valve and are biased to spring back to a pre-formed bent shape for capturing the native heart valve leaflets between the main body and the ventricular anchors. An atrial sealing member may be provided along an atrial portion of the main body for impeding the flow of blood between the main body and the native annulus.

Prosthetic valve for replacing mitral valve

An implantable prosthetic valve includes a radially collapsible and radially expandable annular frame. The frame includes an annular main body sized to be implanted within a native mitral valve annulus. The frame also includes an atrial sealing member coupled to and extending radially away from the main body. The atrial sealing member is sized to extend over tissue of the native mitral annulus within a left atrium to reduce paravalvular leakage. The atrial sealing member includes an inner zig-zag portion and an outer zig-zag portion. The inner zig-zag portion and the outer zig-zag portion are connected to the main body portion only via a fabric to enhance flexibility of the atrial sealing member relative to the main body. The prosthetic valve also includes a valve member disposed within an interior of the frame.

A prosthetic mitral valve can include an outer frame, an inner frame, a valve structure, and a sealing member. The outer frame comprises a plurality of first struts arranged in a lattice pattern and defining a first lumen. The outer frame is self-expandable from a compressed state to an expanded state. The inner frame comprises a plurality of second struts arranged in a lattice pattern and defining a second lumen. The inner frame is disposed within the first lumen of the outer frame, is self-expandable from a compressed state to an expanded state. The valve structure comprises three leaflets made from pericardium and is mounted within the second lumen of the inner frame. The sealing member is coupled to and extends radially outwardly from an atrial end of the outer frame and is configured to engage native tissue of the heart on an atrial side of the native mitral valve.

A prosthetic apparatus for implantation in a native mitral valve includes a main body for placement within the native mitral annulus. The main body is compressible to a radially compressed state for delivery into the heart and is self-expandable from the compressed state to a radially expanded state for implantation. A valve structure is mounted within a lumen of the main body and preferably forms three leaflets made of pericardium. An atrial sealing member is disposed along an atrial portion of the main body and ventricular anchors are coupled to a ventricular portion of the main body. The atrial sealing member impedes the flow of blood between the main body and the native annulus. The ventricular anchors are positioned outside the main body for capturing native mitral valve leaflets between the main body and the ventricular anchors.

A prosthetic heart valve includes a collapsible and expandable frame having a main body, an atrial portion, and at least one ventricular anchor. The atrial portion extends radially outwardly relative to the main body and the ventricular anchor extends from a ventricular end of the main body. The main body and the atrial portion are preferably separate metal components that are coupled together via sutures or a fabric member. The prosthetic heart valve also includes a valve structure that is supported in the main body of the frame. The valve structure has a plurality of leaflets for regulating the flow of blood in one direction.

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Costa Mesa, CA, United States of America

Stephen C Geist