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: 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: A valve treatment device having a coaptation element, a first anchor assembly configured to grasp a first leaflet of a native heart valve, and a second anchor assembly configured to grasp a second leaflet of the native heart valve. The first anchor assembly is connected to a first side of the coaptation element. The second anchor assembly is connected to a second side of the coaptation element. The valve treatment device can include a bioabsorbable central portion between the first anchor assembly and the second anchor assembly.

Abstract: A prosthetic heart valve has a radially expandable and collapsible annular frame, the frame having an inflow end and an outflow end and defining a longitudinal axis along a lumen of the prosthetic heart valve when it is in the expanded configuration. A leaflet structure is positioned within the frame and secured thereto. The prosthetic heart valve also has a laminate sealing member including a plurality of layers heat-bonded together to encapsulate at least a portion of the frame. The laminate sealing member extends along the longitudinal axis in an upstream direction and doubles back toward the outflow end of the frame at a fold line to form a cuff, and an edge portion of the laminate sealing member is secured to a main portion of the laminate sealing member downstream of the fold line such that the cuff forms an inflow end of the laminate sealing member.

Abstract: The present disclosure relates to prosthetic valves that can be expanded to selected maximal diameters. In an example, a prosthetic valve assembly comprises a prosthetic valve having an annular frame, one or more expansion control rods disposed radially outward to the frame, and one or more flexible tension members extending circumferentially around the frame, and comprising one or more local loops wrapped around the corresponding expansion control rods. The flexible tension member is configured to radially expand to a first diameter when all local loops are wrapped around the corresponding expansion control rods, and expand to a second diameter greater than the first diameter, when one of the expansion control rod is retracted from the flexible tension member, thereby allowing the corresponding local loop to unravel.

Abstract: A prosthetic heart valve includes an annular frame, leaflets, each leaflet having opposing commissure tabs, each commissure tab paired with an adjacent commissure tab of an adjacent leaflet to form a commissure, and post members mounted on an interior surface of the frame, where each post member includes an inner side comprising a commissure receiving portion. The commissure comprises a commissure attachment assembly, which comprises a support member disposed around the paired commissure tabs and at least one wire attached to the support member and extending outward from an outer side of the support member. The commissure attachment assembly is secured to a first post member via the at least one wire such that the outer side of the support member is positioned against the commissure receiving portion and the at least one wire is bent around and tightened against the outer side of the first post member.

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 has a radially expandable and collapsible annular frame, the frame having an inflow end and an outflow end and defining a longitudinal axis along a lumen of the prosthetic heart valve when it is in the expanded configuration. A leaflet structure is positioned within the frame and secured thereto. The prosthetic heart valve also has a laminate sealing member including a plurality of layers heat-bonded together to encapsulate at least a portion of the frame. The laminate sealing member extends along the longitudinal axis in an upstream direction and doubles back toward the outflow end of the frame at a fold line to form a cuff, and an edge portion of the laminate sealing member is secured to a main portion of the laminate sealing member downstream of the fold line such that the cuff forms an inflow end of the laminate sealing member.

Abstract: 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.

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: 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: 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.

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.

Abstract: In some aspects, a prosthetic heart valve can include an annular frame, an annular skirt secured to the annular frame, and a suture loop secured to the annular skirt. The annular frame can be radially expandable from a radially compressed configuration to a radially expanded configuration. The annular skirt can include an edge portion. The suture loop can include a plurality of first sections and a plurality of second sections. Each one of the plurality of second sections of the suture loop can be coupled to the frame with a separate suture that extends around the second section.

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.