Edwards Lifesciences Corporation

Noam Nir

Tomer Saar

Tamir S Levi

David Maimon

Elena Sherman

Michael Bukin

Ziv Yohanan

Alexander Barash

Boaz Manash

Yair A Neumann

Bella Felsen

Eran Goldberg

Oren Cohen

Ilan Tamir

Hanoch Cohen-Tzemach

Carmel Peleg

Itai Pelled

Ofir Witzman

Kevin D Rupp

Dikla Kersh

Eitan Atias

Michal Aliza Ruchelsman

Nikolay Gurovich

Liron Tayeb

Mohammad Jafari

Shahram Zamani

Tyler Dale O'Dell

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

Disclosed herein is a storage container for an expandable prosthetic heart valve that crimps the valve upon opening the container and removal of the valve from the container. The container includes a housing sized to receive the heart valve in its expanded configuration and a crimping mechanism. The crimping mechanism is incorporated into the container and engages the heart valve so as to operably convert the heart valve from its expanded configuration to its smaller crimped configuration upon opening the container and removing the valve.

Transcatheter heart valve storage container and crimping mechanism

An implantable prosthetic valve assembly, according to one embodiment, comprises a frame assembly including a plurality of struts and a prosthetic valve secured inside the frame assembly by sutures. The sutures are inward of the outermost surface of an outer periphery of the frame assembly. In certain embodiments the struts contain recesses in which sutures can be disposed. In other embodiments, the struts can have holes through them which the sutures pass through. The implantable prosthetic valve assembly can also be collapsed within a catheter such that an outermost surface of a periphery of the frame assembly touches the catheter but the sutures are spaced apart from the catheter or are flush with the outer surface of the frame.

Heart valve frame design with non-uniform struts

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

In one embodiment, a prosthetic valve assembly includes an annular frame being radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, a valvular structure comprising a plurality of leaflets mounted inside the annular frame, a plurality of posts mounted on an interior surface of the annular frame, and a pair of commissure attachment members extending outwardly from each post and away from each other. Each two adjacent leaflets can form a pair of commissure tabs. Each pair of commissure tabs can be attached to a corresponding pair of the commissure attachment members.

Mechanically expandable heart valve

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 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.

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.

A prosthetic valve assembly includes a radially expandable and compressible annular frame. The frame includes a plurality of interconnected struts, which include a plurality of inner struts and a plurality of outer struts. The inner struts overlap adjacent outer struts at a plurality of pivot joints. Radial expansion or compression of the annular frame causes the inner struts to pivot relative to the outer struts at the pivot joints. The assembly also includes a valvular structure having a plurality of leaflets, each leaflet having a cusp edge portion. The assembly further includes one or more leaflet-supporting cords, each having a plurality of anchoring portions and a plurality of suspended portions, each suspended portion extending between two adjacent anchoring portions. The anchoring portions are affixed to respective anchoring features of the frame adjacent the pivot joints. The cusp edge portions of the leaflets are connected to the suspended portions.

Prosthetic heart valve

Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. The delivery system can include a number of advantageous steering and delivery features, in particular for the transseptal delivery approach.

Steerable delivery system for replacement mitral valve and methods of use

Embodiments of a prosthetic heart valve are disclosed. An implantable prosthetic valve may be radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. The prosthetic valve may comprise an annular frame, a leaflet structure positioned within the frame and a plurality of outer skirts positioned around an outer surface of the frame, each outer skirt comprising an inflow edge secured to the frame and an outflow edge secured at intervals to the frame. The plurality of outer skirts may include a first outer skirt and a second outer skirt, wherein in the expanded configuration the first and second outer skirts include openings unsecured to the frame between the intervals. The inflow edge of the first annular outer skirt may be secured to the frame with sutures including radiopaque material. The first annular outer skirt may include radiopaque dye.

Prosthetic heart valve having multi-level sealing member

A method for improving leaflet prolapse and/or valve regurgitation associated with a heart valve involves delivering a spacer device into a ventricle of a heart using a delivery system comprising a catheter, fixing the spacer device to a wall of the ventricle, expanding the spacer device to reposition a papillary muscle disposed in the ventricle away from the wall, the papillary muscle being connected to a leaflet of an atrioventricular heart valve via chordae tendineae, and releasing the spacer device from the catheter.

Growing community of inventors

Gesher HaZiv, Israel

Noam Nir