Edwards Lifesciences Corporation

Nikolay Gurovich

Ziv Yohanan

Tamir S Levi

Elena Sherman

Bella Felsen

Netanel Benichou

Son V Nguyen

David Maimon

Ron Sharoni

Larisa Dadonkina

Michael Bukin

Boaz Manash

Oded Meiri

Itai Pelled

Dikla Kersh

Diana Nguyen-Thien-Nhon

Liron Tayeb

Dinesh L Sirimanne

Alexander Barash

Larry L Wood

Timothy A Geiser

Dan Rottenberg

Tomer Saar

Yair A Neumann

Eran Goldberg

Hernan Altman

Khen Perlmutter

Danny M Garmahi

Amir Blumenfeld

Adi Carmi

Arie Tylis

Hagar Adika

Tal Regev

Alexey M Tsypenyuk

Noam Nir

Waina Michelle Chu

Noa Axelrod Manela

Mohammad Jafari

Gil Senesh

Noa Axelrod

Ilan Tamir

Anatoly Dvorsky

Alexey Tsypenyuk

Eran Grosu

A method of treating mitral valve stenosis in a human heart includes advancing a delivery apparatus through a right femoral vein, across a septal wall, and through a calcified mitral valve. A prosthetic heart valve is provided along a distal end portion of the delivery apparatus, wherein the prosthetic heart valve includes a metallic frame having a plurality of tissue-engaging elements positioned along an exterior surface and a leaflet structure for replacing the function of the calcified mitral valve. The prosthetic heart valve is radially expanded within an annulus of the calcified mitral valve such that at least some of the tissue-engaging elements of the prosthetic heart valve embed into the annulus. After radial expansion, the prosthetic heart valve is retained in position within the annulus via the tissue-engaging element and the leaflet structure replaces the function of the native mitral valve.

Method of treating mitral valve stenosis

A prosthetic heart valve includes a frame, a valvular structure, and a skirt. The frame is movable between collapsed and expanded configurations and includes struts disposed between inflow and outflow ends, apices disposed at the inflow end formed by intersections of two or more struts, and junctions disposed between the apices and the outflow end and formed by intersections of two or more struts. The apices are circumferentially offset from the junctions. The valvular structure is positioned within and secured to the frame. The skirt is secured to the frame and includes a first edge portion and a second edge portion. The first edge portion is secured to the frame at the apices. The second edge portion is secured to the frame at the junctions. The skirt is configured to retract inwardly between the apices when the frame is moved from the radially expanded configuration to the radially collapsed configuration.

Prosthetic heart valve

A prosthetic valve has an annular frame including a plurality of strut members that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. A leaflet structure is situated at least partially within the frame. The leaflet structure includes a plurality of leaflets, each leaflet having opposing commissure tab portions on opposite sides of the leaflet. Each commissure tab portion is paired with an adjacent commissure tab portion of an adjacent leaflet to form a commissure. The commissure tab portions of each leaflet are folded to form a plurality of layers positioned on the inside of the frame. A reinforcement member is positioned between the layers of each commissure tab portion.

Devices and methods of commissure formation for prosthetic heart valve

Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

An anchoring system and related methods are provided for treatment of dilated hearts and of functional valve regurgitation, the system comprising one or more self-expandable or manually expandable anchors and associated devices for fixating a valve splint within the heart. For example, a spade-shaped assembly may be configured to be deployed in a right ventricle of the heart and to stabilize a puncturing instrument to puncture the septum. Various puncturing instruments may also be part of the anchoring system, including one or more of a flexible needle having a multiplicity of slits disposed along the length of the needle, a trocar catheter with a retractable head, and a catheter needle having a blunt introducer to protect nearby tissue within the heart during advancing a guidewire. A cutter catheter and puncture location catheter may also be part of the system and be used during treatment.

Systems and devices for setting an anchor

A prosthetic heart valve includes a frame, a valvular structure coupled to the frame, and a sealing member coupled to the frame. The frame has inflow and outflow ends and a lumen extending therebetween. The frame includes struts that form cells, and the cells are arranged in three rows. The frame is radially expandable from a collapsed state to an expanded state. The valvular structure includes a plurality of leaflets configured to allow blood flow through the lumen of the frame from the inflow end to the outflow end and to block blood flow through the lumen of the frame from the outflow end to the inflow end. The sealing skirt extends from an intermediate location of the frame disposed between the inflow and outflow ends to the inflow end of the frame. The sealing skirt covers two rows of cells to block blood flow through the cells.

Perivalvular sealing for transcatheter heart valve

A method of implanting a prosthetic heart valve within a patient can comprise inserting a distal end portion of a delivery apparatus and a prosthetic heart valve into the patient and advancing the prosthetic heart valve to a deployment location within the heart of the patient and inflating one or more of a plurality of differently-sized balloons in a balloon-assembly on the distal end portion of the delivery apparatus. The prosthetic heart valve can be mounted on the balloon assembly in a crimped state and the inflating of the one or more of the plurality of differently-sized balloons can expand the prosthetic heart valve from the crimped state to a radially expanded state having a non-cylindrical shape.

Prosthetic heart valve having improved commissure supports

A prosthetic heart valve includes an annular frame including a plurality of strut members that is radially collapsible and expandable. A leaflet structure is situated within the frame, and includes a plurality of leaflets having opposing commissure tab portions on opposite sides of the leaflet. Each commissure tab portion is paired with an adjacent commissure tab portion of an adjacent leaflet to form one or more commissures. A commissure support element is positioned at each of the commissures, and comprise a first member and a second member that are separable from each other and configured to receive leaflets therebetween. The first and second members are detached from the frame and spaced radially inwardly from the frame such that the members contact the leaflets radially inward from the frame and limit movement of the leaflets so that they articulate at a location that is spaced radially inwardly from the frame.

A prosthetic heart valve can include a radially collapsible and expandable annular frame having a plurality of struts defining openings. The prosthetic heart valve can further include a plurality of leaflets that regulate the flow of blood through the frame. The prosthetic heart valve can also include a sealing member mounted on the frame and having an inner layer and an outer layer. At least the outer layer is mounted on the outside of the frame, and the inner layer covers at least the openings in the frame between adjacent cusp portions of adjacent leaflets and the inner layer does not cover one or more openings in the frame at locations facing the outflow surfaces of the leaflets to permit retrograde blood to flow through the one or more uncovered openings in the frame and into space between the outer layer and the frame.

A prosthetic heart valve is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. The heart valve includes an annular inner frame formed with a plurality of angled first strut members, the inner frame being configured to foreshorten from a first length corresponding to the collapsed configuration to a second length corresponding to the expanded configuration. A leaflet structure is situated at least partially within the inner frame. An outer frame is disposed radially outward of the inner frame and coupled to the inner frame. The outer frame is configured to collapse with the inner frame and radially expand with the inner frame, and includes a plurality of second strut members. Portions of the second strut members are configured to bend radially outwardly into a curved shape as the inner frame and the outer frame move from the collapsed configuration to the expanded configuration.

Frame for prosthetic heart valve

An implantable prosthetic valve can comprise an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame defining an axial direction extending from the inflow end to the outflow end, a leaflet structure positioned within the frame and secured thereto, and an annular outer skirt positioned around an outer surface of the frame, wherein the outer skirt comprises an inflow edge secured to the frame at a first location, an outflow edge comprising a plurality of alternating projections and notches, wherein the projections are secured to the frame at a second location, and the notches are not directly secured to the frame, an intermediate portion between the inflow edge and the outflow edge that comprises a plurality of openings.

Growing community of inventors

Hadera, Israel

Nikolay Gurovich