Edwards Lifesciences Corporation

Ziv Yohanan

Tamir S Levi

Elena Sherman

Nikolay Gurovich

Netanel Benichou

David Maimon

Bella Felsen

Michael Bukin

Son V Nguyen

Ron Sharoni

Larisa Dadonkina

Yair A Neumann

Alexander Barash

Tomer Saar

Nikolai Gurovich

Boaz Manash

Oded Meiri

Noam Nir

Itai Pelled

Liron Tayeb

Dikla Kersh

Ofir Witzman

Oren Cohen

Waina Michelle Chu

Elazar Levi Schwarcz

Noam Miller

Alexey Tsypenyuk

Gil Senesh

Anatoly Dvorsky

Michael G Valdez

Eran Goldberg

Tram Ngoc Nguyen

Khen Perlmutter

Eitan Atias

Jonathan Bar-Or

Eyal Leiba

Alexey M Tsypenyuk

Nik Gurovich

Mohammad Jafari

Ilan Tamir

Danny M Garmahi

Shahram Zamani

Yana Mayatskaya

Tyler Dale O'Dell

Gideon Sagi

Haim Yushtein

The present invention relates to implantable prosthetic devices, such as prosthetic heart valves, and to attachment configurations and methods of attaching soft components, such as leaflets or skirts, to frames of such prosthetic valves.

Leaflet attachment configurations to the frames of prosthetic valves

Embodiments of a prosthetic valve delivery apparatus are disclosed. The delivery apparatus includes a first portion configured to maintain a fixed spatial relationship relative to a first end of the prosthetic valve and a second portion configured to maintain a fixed spatial relationship relative to a second end of the prosthetic valve during radial expansion of the prosthetic valve. The first portion includes one or more reference radiopaque markers and the second portion includes an indicator radiopaque marker. A position of the indicator radiopaque marker relative to the one or more reference radiopaque markers measures an axial distance between the first and second ends of the prosthetic valve indicative of a corresponding diameter of the prosthetic valve as it is radially expanded from a radially compressed state to a radially expanded state.

Apparatus and method for monitoring valve expansion

A prosthetic heart valve and associated methods for assembling a prosthetic heart valve including a plurality of leaflets is disclosed. As one example, a prosthetic heart valve includes a frame; a plurality of commissure support elements, each connected the frame and including two axially-extending members spaced apart from one another to form a window; and a plurality of leaflets, each leaflet comprising a body and two opposing commissure tabs, each commissure tab arranged adjacent to another commissure tab to form a pair of commissure tabs that are disposed in a commissure support element to form a commissure. Each commissure tab includes a series of overlapping layers that include a first set of two overlapping layers that extends through the window and a second set of two overlapping layers that extends away from the first set of two overlapping layers and over an outer side of a corresponding axially-extending member.

Prosthetic heart valve leaflet commissure assemblies and methods

A method can comprise deploying a prosthetic valve with a delivery apparatus, where the prosthetic valve comprises a frame and a rotatable screw connected to the frame, and where the screw comprises a screw head having an annular bore with internal threads. The delivery apparatus is releasably coupled to the screw and can comprise a first shaft and a first head disposed at an end of the first shaft, the first head comprising external threads releasably engaged with the internal threads of the screw head, and a second shaft that is coaxial with and surrounds the first shaft, the second shaft comprising a second head disposed at an end of the second shaft, the second head releasably engaged with an exterior surface of the screw head. Deploying the valve includes radially expanding the prosthetic valve by rotating the screw with the delivery apparatus.

Mechanically expanding heart valve and delivery apparatus therefor

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.

Prosthetic 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 can include a radially expandable and compressible frame having an inflow end portion and an outflow end portion, the frame comprising a plurality of struts defining openings between them. The prosthetic valve can further include a valvular structure comprising a plurality of leaflets, each leaflet comprising a main body, opposing tabs on opposite sides of the main body, a coaptation edge portion, and a cusp edge portion. Each tab can be paired with an adjacent tab of an adjacent leaflet to form a plurality of commissures that are fixed relative to the frame, and each leaflet can have opposing edge portions between the opposing tabs and the cusp edge portion that are unattached to the frame, each unattached edge portion defining a gap that extends radially into the main body of the leaflet.

A method of assembling a valvular structure can include folding an upper tab of a first leaflet onto a lower tab of the first leaflet, disposing a first end of a reinforcing member on the upper tab, disposing a commissure member adjacent the lower tab, and coupling the first end of the reinforcing member, the tabs of the first leaflet, and the commissure member to one another. The method can further include folding an upper tab of a second leaflet onto a lower tab of the second leaflet, disposing the second leaflet adjacent the first leaflet such that the commissure member is positioned between the lower tabs, disposing a second end of the reinforcing member on the upper tab of the second leaflet, and coupling the reinforcing member, the upper and lower tabs of the second leaflet, and the commissure member to one another to form a commissure.

Prosthetic heart valve leaflet assemblies and methods

A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end, an outflow end, and a plurality of struts. The prosthetic valve can further include a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion. The cusp edge portion of each leaflet can be folded toward the outflow end of the frame along a bending axis and a reinforcing member extends along an outflow surface of the cusp edge portion along the bending axis. The prosthetic heart valve can include a plurality of connecting skirts, each disposed between the cusp edge portion of an adjacent leaflet and the frame. First stitching secures the reinforcing member and the connecting skirts to the cusp edge portions and second stitching secures the connecting skirts to selected struts of the frame.

In one embodiment, a method of assembling a prosthetic valve can comprise forming a radially expandable and compressible frame by pivotally joining together a plurality of struts without requiring individual rivets. In some embodiments, the frame is formed by interweaving the struts, which can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In other embodiments, separate hinges are provided to interconnect the struts. In still other embodiments, separate flanged rivets are provided to connect the struts.

Mechanically expandable heart valve

An assembly can comprise a prosthetic valve comprising a radially expandable and compressible frame and a rotatable screw connected to the frame, where the screw comprises a screw head having an annular bore with internal threads, and where the screw is rotatable to radially expand the frame. The assembly further comprises a delivery apparatus releasably coupled to the screw, the delivery apparatus comprising a first shaft and a first head disposed at an end of the first shaft, the first head comprising external threads configured to engage with the internal threads of the screw head, and a second shaft that is coaxial with and surrounds the first shaft, the second shaft comprising a second head disposed at an end of the second shaft. The second head is configured to releasably engage with an exterior surface of the screw head and rotate the screw.

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

A system can include a delivery catheter comprising a balloon and an implantable prosthetic heart valve. The prosthetic valve can have a plastically expandable and compressible unitary frame comprising first, second, and third rows of angled struts that define two circumferentially extending rows of diamond-shaped cells that extend continuously around the frame, and a valvular structure comprising a plurality of leaflets. A cusp edge portion of each leaflet is connected to the frame by a skirt that is connected to and disposed between the frame and the cusp edge portions of the leaflets, the skirt being connected to consecutive struts in the first, second, and third rows of struts with sutures. The compressed prosthetic heart valve can be mounted around the balloon and radially expanded to the expanded configuration with the balloon inside a patient's body.

A system can include a delivery catheter comprising a balloon and an implantable prosthetic heart valve. The prosthetic valve can have a plastically expandable and compressible unitary frame comprising a plurality of circumferentially extending rows of angled struts, including first, second, and third rows of angled struts forming rows of diamond-shaped cells, and a valvular structure comprising a plurality of leaflets. A cusp edge portion of each leaflet is connected to the frame by a skirt that is disposed between the frame and the cusp edge portions, the skirt being sutured to selected struts of the frame along diagonal paths extending from an inflow end portion toward an outflow end portion. Each diagonal path along which the skirt is sutured to the frame extends along the first, second, and third rows of angled struts.

Growing community of inventors

Kfar Hahoresh, Israel

Ziv Yohanan