Abstract: 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.

Abstract: A prosthetic heart valve and delivery device for delivering the prosthetic heart valve to a target implantation site, which reduce contact between the prosthetic heart valve and a delivery sheath through which the delivery device is advanced to the target implantation site, is disclosed. As one example, a prosthetic heart valve may comprise a frame including a first end with a plurality of apices spaced apart from one another around a circumference of the first end and a cover element covering the plurality of apices. The cover element may include a cushioning element or a bio-resorbable element.

Abstract: Adjustable leaflets for prosthetic heart valves are disclosed. As an example, a leaflet for a prosthetic valve can include a main body with a free, outflow edge and a cusp edge portion, and two tabs disposed on opposite sides of the main body, adjacent to the outflow edge. Each tab can include a tab body extending from the main body of the leaflet and a plurality of projections extending outward from the tab body. The projections of the plurality of projections are spaced apart from one another along the tab body to form a plurality of notches therebetween.

Abstract: An implantable prosthetic device can include a radially expandable and compressible frame including an inflow end portion and an outflow end portion. The frame can include an expansion and locking mechanism comprising a member having a first set of lateral extensions disposed adjacent an outflow end and a second set of lateral extensions axially spaced from the first set, each lateral extension comprising a bore extending into the lateral extension. The frame can further comprise a commissure attachment member having a first set of arms each extending into a respective inner bore of the first set of lateral extensions and a second set of arms each extending into a respective inner bore of the second set of lateral extensions such that the commissure attachment member is restrained from movement relative to the expansion and locking mechanism in the radial and axial directions.

Abstract: 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.

Abstract: Disclosed are techniques for construction of prosthetic heart valves, particularly techniques for attachment of scalloped edges of valvular leaflets to struts of mechanical frames using sutures and/or other materials as intermediate coupling members. In some embodiments, the scalloped edges of the leaflets are coupled to the segments of the struts of the frame via suture loops that are oriented transverse to the scalloped edges of the leaflets. In some embodiments, central portions of scallop line segments are attached to the scalloped edges of the leaflets and are not attached to the frame. In some embodiments, strut segments are tapered to limit translation of suture loops. In some embodiments, a cloth strip couples the scalloped edges of the leaflets to frame struts. In some embodiments, the scalloped edge is attached to adjacent segments of intersecting struts via sliding suture loops, where the adjacent segments join at a common pivot joint.

Abstract: A device may include a frame including an inflow end and an outflow end. The frame defines a lumen between the inflow end and the outflow end. A device may include a first expandable member coupled to at least one portion of an internal surface of the frame and including a first inflation port. The first expandable member defines a first volume configured to receive an inflation fluid therein through the first inflation port. The first expandable member is configured to be reversibly inflatable to a first plurality of inflation states to partially or fully occlude the lumen. The devices described herein may be used to alleviate symptoms from congestive heart failure or chronic kidney disease.

Abstract: The present disclosure relates prosthetic valves and assemblies that include an outer skirt releasably coupled to the frame or to another skirt of the prosthetic valve. In an example, a prosthetic valve assembly includes a prosthetic valve comprising an annular frame and a first skirt attached to the frame, and a second skirt disposed radially outward to the first skirt and releasable coupled to the first skirt via at least one retaining suture attached to the frame and extending through inflow and outflow loops of the first and second skirts. The second skirt is configured to be released from the first skirt upon withdrawal of the at least one retaining suture from the inflow and outflow loops of both skirts.

Abstract: Disclosed herein are prosthetic valves with outer skirts that include patterned threads extending over base layers thereof to provide PVL sealing functionality, and methods for forming such patterned outer skirts. As one example, a prosthetic valve can include an annular frame and an outer skirt disposed around the frame, wherein the outer skirt comprises a base layer, a multi-yarn thread comprising a plurality of multi-filament yarns, and a backing thread. The multi-yarn thread can be embroidered to the base layer and define outer portions extending over an outer surface of the base layer, while the backing layer extends over an inner surface of the base layer, and is wound over the multi-yarn thread at stitch points defined at ends of the outer portions.

Abstract: A prosthetic heart valve includes a frame having an inflow end and an outflow end, and defining a longitudinal axis. The prosthetic heart valve further includes a leaflet structure situated at least partially within the frame, and a covering disposed around the frame. The covering includes a first woven portion extending circumferentially around the frame and including a plurality of texturized strands or yarns extending along the longitudinal axis of the frame. The covering further includes a second woven portion extending circumferentially around the frame and spaced apart from the first woven portion along the longitudinal axis of the frame. The texturized strands extend along the longitudinal axis of the frame from the first woven portion to the second woven portion and form a floating portion between the first woven portion and the second woven portion.

Abstract: Prosthetic heart valves and methods for assembling prosthetic heart valves are disclosed. As one example, a prosthetic heart valve includes a frame, commissure support elements, and leaflets, each leaflet comprising a body and opposing commissure tabs, each commissure tab folded over from a corresponding body to form a bend between the commissure tab and body and arranged adjacent to another folded commissure tab of an adjacent leaflet to form a pair of commissure tabs that is coupled to one commissure support element to form a commissure. Each commissure tab is secured to the commissure support element via a reinforcement member positioned against the commissure tab, adjacent to the bend, and secured to and/or at least partially wrapped around the commissure tab and the commissure support element, the reinforcement member comprising a flexible body and a more rigid, central portion, the central portion positioned along a height of the commissure tab.

Abstract: An implantable device or implant is configured to be positioned within anatomy such as a native heart valve to repair the valve. The implantable device or implant is configured to be attached to one or more portions of the anatomy or native heart valve, such as one or more portions thereof can be moved closer together. For example, native valve leaflets, chordae tendinea, papillary muscles, a leaflet cleft, etc. can be moved to prevent or inhibit regurgitant flow through the native valve.

Abstract: 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.

Abstract: 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.

Abstract: A prosthetic heart valve includes a frame. The frame has a plurality of strut members, and is radially collapsible and expandable between a collapsed configuration and an expanded configuration. The frame has an inflow end and an outflow end, and defines a longitudinal axis. A leaflet structure is situated at least partially within the frame. A fabric covering is disposed around the frame, and the fabric covering has a non-woven floating portion extending circumferentially around the frame.

Abstract: A prosthetic valve includes an annular frame and a valvular structure mounted within the annular frame. The valvular structure comprises a plurality of leaflets and a plurality of offset elements. Each leaflet includes a leaflet free edge that is offset in an axial direction from the commissures by upper material portions that are unattached to the frame. Commissures are formed by primary tabs on the side edges of adjacent leaflets attached to secondary tabs on opposing ends of the offset elements. A bridge portion of the offset elements extends over an end portion of the leaflet free edges of the adjacent leaflets and is moveable between a neutral position and a radially outward shifted position. An articulation axis between the adjacent leaflets is offset greater distance from the frame when the bridge portion is in the neutral position relative to when the bridge portion is in the radially outward shifted position.

Abstract: 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.

Abstract: The present disclosure relates to prosthetic valve that include leaflets coupled to a frame by clamping members, optionally in a sutureless manner. In an example, a prosthetic valve can include at least one stapling member coupling at least one leaflet of a plurality of leaflets to the frame, wherein the clamping member comprises a plurality of stapling portions separated from each other along a spine of the clamping member. Each stapling member can include a pair of legs extending from opposite ends of a backspan, wherein the legs extend through the leaflet and are bent around a corresponding strut of the frame, thereby coupling the leaflet to the frame.

Abstract: A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end and an outflow end, the frame comprising a plurality of struts defining openings between them, a valvular structure comprising a first leaflet including a first commissure tab and a second leaflet including a second commissure tab, and commissure attachment member. The commissure attachment member can be folded to define a central portion comprising a first surface and a second opposing surface, a first side portion extending from the first surface, and a second side portion extending from the first surface. The first and second commissure tabs can be disposed between and secured to the first and second side portions. The central portion and the first and second side portions of the commissure attachment member can be located inside of the frame.

Abstract: 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.