Edwards Lifesciences Corporation

Other

Metacure Limited

Tamir S Levi

Elena Sherman

Netanel Benichou

Son V Nguyen

Ziv Yohanan

David Maimon

Bella Felsen

Ron Sharoni

Michael Bukin

Nikolay Gurovich

Larisa Dadonkina

Diana Nguyen-Thien-Nhon

Yaacov Nitzan

Ilia Hariton

Itai Pelled

Rajesh A Khanna

Noam Nir

Nikolai Gurovich

Ofir Witzman

Tri D Tran

Dikla Kersh

Hanoch Cohen-Tzemach

Mindy Lee Ann Black

Ajay Chadha

Khen Perlmutter

Waina Michelle Chu

Oded Meiri

Emil Karapetian

Tung Thanh Le

Boaz Manash

Yair A Neumann

Dinesh L Sirimanne

Alexander Barash

Linda Thai

Rajesh Khanna

Gil Senesh

Alexey Tsypenyuk

Darshin S Patel

Sean Chow

Michael R Bialas

Yidong M Zhu

Kevin D Rupp

Larry L Wood

Timothy A Geiser

Jeff Lindstrom

Evan T Schwartz

Oren H Wintner

Benny Rousso

David J Evans

Liron Tayeb

Ronaldo C Cayabyab

Oren Cohen

Hernan Altman

Christopher Chia

Eitan Atias

Noa Axelrod Manela

Elazar Levi Schwarcz

Sandip Vasant Pawar

Anatoly Dvorsky

Noam Miller

Danny M Garmahi

Taylor Jacob Scheinblum

Yaron Keidar

Benjamin Spenser

Yuval Elovici

Tomer Saar

Michael G Valdez

Eran Goldberg

Elazar Sonnenschein

Tram Ngoc Nguyen

Amir Govrin

Minelu Sonnenschein

Offer Glasberg

Eyal Leiba

Paul Richard Spehr

Tami Harel

Gregory Rinberg

Yuanlong Du

Chambory Chhe

Shahram Zamani

Yana Mayatskaya

Som Nguyen

Arpit Laddha

Ngoc Huong Thi Nguyen

Nik Gurovich

Lena Milman

Sara Haivatov

Alexey M Tsypenyuk

Giolnara Pinhas

Liraz Marom

Noam Mizrahi

Delfin Rafael Ruiz

Melissa Denton Young

Haim Yushtein

Tyler Dale O'Dell

Itay Avinathan

Gideon Sagi

Martyn Rhys Thomas

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 an implantable prosthetic valve are disclosed. The valve can have an annular frame having a plurality of frame members and a skirt assembly. The skirt assembly can include a laminate having a fabric layer sandwiched between a first covering member and a second covering member. At least one surface of the fabric layer can be exposed at one or more windows in the second covering member. The skirt assembly can be coupled to the annular frame by a suture extending through the fabric layer at the one or more windows and around at least one of the plurality of frame members. Methods for making such an implantable prosthetic valve are also disclosed.

Skirt assembly for implantable prosthetic valve

A device for crimping a radially expandable and collapsible prosthetic valve comprises a crimping loop having a first end portion, a second end portion, and a loop portion extending between the first and second end portions and defining an opening configured to receive the prosthetic valve. The crimping loop is movable between a first state in which the opening has a first diameter and a second state in which the opening has a second diameter smaller than the first diameter such that when the prosthetic valve is positioned within the loop portion, movement of the crimping loop from the first state to the second state is effective to reduce a diameter of the prosthetic valve. A method for crimping a prosthetic valve comprises reducing a diameter of an opening of a crimping loop, thereby radially compressing an at least partially expanded prosthetic valve disposed within the opening.

System and method for crimping a prosthetic heart valve

A prosthetic heart valve includes an annular frame that is radially collapsible and radially expandable, a plurality of leaflets situated within the frame, each leaflet having opposing commissure tab portions on opposite sides of the leaflet, each commissure tab portion paired with an adjacent commissure tab portion of an adjacent leaflet to form at least one commissure, and a plurality of post members mounted on an interior surface of the frame. The at least one commissure includes a commissure attachment assembly including a support member disposed at least partially around the commissure tab portions and the commissure tab portions are folded around the support member. The commissure attachment assembly is secured to a first post member of the plurality of post members such that the commissure tab portions are positioned between the first post member and the support member.

Commissure attachment for prosthetic heart valve

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

Assembly methods for installing a leaflet assembly to an expandable frame of a prosthetic heart valve are described. The leaflet assembly comprises a plurality of leaflets coupled together at adjacent tabs, which form respective commissure tab assemblies. The commissure tab assemblies are inserted into corresponding windows of support members of the expandable frame. One or more wedge members are inserted into the commissure tab assembly, e.g., between the adjacent tabs or with the adjacent tabs therebetween, to restrain radial motion of the commissure tab assembly with respect to the window. The window can be a closed window, and the wedge member insertion can be after the commissure tab assembly is inserted into the window. Alternatively, the window can be an open window or channel, and the wedge member insertion can be before the commissure tab assembly is installed in the window.

Prosthetic heart valve leaflet assemblies and methods

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

An implantable prosthetic device can include a frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The frame can have a first set of a plurality of struts extending in a first direction, and a second set of a plurality of struts extending in a second direction, and each strut of the first set of struts can be pivotably connected to at least one strut of the second set of struts. Each strut can be curved helically with respect to a first, longitudinal axis of the frame, and each strut can be curved with respect to a second axis that is perpendicular to the first, longitudinal axis of the frame.

Prosthetic heart valve having non-cylindrical frame

A method of assembling a prosthetic heart valve comprises securing a suture loop having at least first and second windings to an outflow edge portion of an inner skirt. The first and second windings are arranged in a repeating pattern of figure-eight shape curves and each winding has a plurality of first sections attached to the outflow edge portion of the inner skirt and a plurality of second sections unattached to the inner skirt. The inner skirt is placed inside of an annular frame and the second sections of the first and second windings are placed over apices of an outflow end of the frame such that the second sections of the first and second windings reside outside of the frame. The second sections of the windings are inserted inwardly through openings in the frame and attached to selected locations on the inner skirt.

Method of assembling a 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 radially expandable prosthetic valve can comprise an annular frame, at least one expansion mechanism and a cord. The annular frame can be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The expansion mechanism can comprise a first member attached to the frame at a first location and a second member attached to the frame at a second location axially spaced from the first location. The cord can extend at least partially along the expansion mechanism in a first direction, be reeved around a portion of the second member, and extend at least partially along the expansion mechanism in a second direction opposite the first direction. Applying a proximally directed force to a first portion of the cord can cause the second member to move relative to the first member, which can cause the frame to foreshorten axially and expand radially.

Mechanically expandable prosthetic heart valve and delivery apparatus

A method of treating a deficient native mitral valve of a heart of a patient includes advancing a steerable, first catheter through the patient's vasculature, advancing the distal end portion of the first catheter into the heart to position the distal end portion of the first catheter adjacent the native mitral valve, adjusting the curvature of the distal end portion of the first catheter to form a first curve, advancing a distal end portion of a second catheter from a distal end of the first catheter, wherein the distal end portion of the second catheter is pre-shaped to form a second curve when advanced from the first catheter, and deploying a wire from the second catheter such that the wire extends around native leaflets of the native mitral valve.

Methods for treating a deficient native mitral valve

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.

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.

Growing community of inventors

Zikhron Yaakov, Israel

Tamir S Levi