Abstract: A prosthetic heart valve includes a frame that is radially collapsible and expandable between a collapsed configuration and an expanded configuration, and defines a longitudinal axis. A leaflet structure situated within the frame, and a sealing member is disposed around the frame. The sealing member can include a first portion extending circumferentially around a portion of the frame, the first portion being configured to resiliently stretch in a direction along the longitudinal axis between a first state corresponding to the expanded configuration of the frame and a second state corresponding to the collapsed configuration of the frame. The sealing member can include a second portion extending circumferentially around a portion of the frame, the second portion being configured to resiliently stretch in a circumferential direction between a first state corresponding to the collapsed configuration of the frame and a second state corresponding to the expanded configuration of the frame.

Abstract: Prosthetic implant systems for diameter adaptation may be provided. The systems may provide for increased flexibility of providing implants having various diameters, and reducing expense associated with keeping a stock of implants at various sizes. Embodiments as disclosed herein may utilize a prosthetic implant having a docking frame that may be configured to expand to a range of working diameters. The docking frame may dock with a valve frame that may be configured to expand to a working diameter that is more closely tailored to the diameter of the implantation site. The valve frame may have a lesser range of expansion of working diameters than the docking frame.

Abstract: A prosthetic valve assembly includes a prosthetic valve and an anchoring frame. The prosthetic valve includes a valve frame and a valve structure. The valve frame includes a plurality of struts and is expandable from a compressed configuration to an expanded configuration. The valvular structure includes leaflets. The valvular structure is disposed radially within and is coupled to the valve frame. The valvular structure is configured to allow blood flow through the prosthetic valve assembly in a first direction and to restrict blood flow through the prosthetic valve assembly in a second direction. The anchoring frame includes a plurality of struts. The anchoring frame is disposed radially outwardly from and is coupled to the valve frame. The struts of the anchoring frame comprise one or more tissue-engaging elements configured for contacting native tissue to help secure the prosthetic valve assembly at an implantation location.

Abstract: A prosthetic valve has a radially expandable and compressible frame including a plurality of interconnected struts and a valvular structure including a plurality of leaflets configured to regulate the flow of blood through the prosthetic valve. The leaflets can have undulating cusp edge portions. The prosthetic valve further includes at least one connecting skirt having a shape that corresponds to the cusp edge portion of at least one leaflet. The connecting skirt can connect the cusp edge portion of the leaflet to at least one of the struts of the frame. The connecting skirt can include a first set of yarns intersecting with a second set of yarns. The first and second sets of yarns can extend at oblique angles relative to a longitudinal axis of the at least one strut.

Abstract: A prosthetic heart valve and associated methods for assembling a prosthetic heart valve including an annular frame and a plurality of leaflets is disclosed. As one example, the valve includes a plurality of commissures, each commissure including an attachment member including a protruding portion, a first commissure tab of a first leaflet of the plurality of leaflets arranged adjacent to a first side of the protruding portion and secured directly to the attachment member. Each commissure further includes a second commissure tab of a second leaflet of the plurality of leaflets arranged adjacent to an opposite, second side of the protruding portion and secured directly to the attachment member.

Abstract: A buckle commissure clamp can be used to attach leaflets of a valvular structure to a frame of a prosthetic heart valve. Tabs of adjacent leaflets can be assembled to the buckle commissure clamp by passing each leaflet through one or more gaps of the buckle commissure clamp. Each leaflet tab can be wrapped around portions of the buckle commissure clamp. Once the leaflet tabs are assembled to the buckle commissure clamp, the assembly can be attached to the frame, for example, by one or more sutures extending between the buckle commissure clamp and a support member, such as a strut of the frame, an actuator of the frame, a locking mechanism of the frame. In some embodiments, the buckle commissure clamp has a substantially W-shape or M-shape.

Abstract: An implantable prosthetic device can include a frame movable between a radially compressed and a radially expanded configuration and a sealing member. The frame can include an inflow end portion, an outflow end portion, and a plurality of struts. The sealing member can be disposed around the frame and can include a cushioning layer comprising a plurality of texturized yarns extending along the longitudinal axis of the frame, and a base layer disposed between the cushioning layer and the frame.

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: An assembly and associated method for a commissure of a prosthetic heart valve is disclosed. As one example, a method includes forming a plurality of commissures with a plurality of leaflets of a prosthetic heart valve, wherein each commissure is formed by: folding each commissure tab of each leaflet into a series of overlapping layers, each folded commissure tab arranged outward of, in a lateral direction, a portion of a body of the leaflet that is directly connected to the commissure tab; pairing each folded commissure tab of each leaflet with a folded commissure tab of another leaflet; and securing at least a portion of the series of overlapping layers of each folded commissure tab in its folded configuration.

Abstract: 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.

Abstract: 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.

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: An assembly and associated method for a commissure of a prosthetic heart valve is disclosed. As one example, a method includes forming each of a plurality of commissures with a plurality of leaflets by pairing a first commissure tab of a first leaflet with an adjacent, second commissure tab of a second leaflet, folding a support strip over an inner reinforcing element, positioning the folded support strip between the first and second commissure tabs, and attaching first and second outer reinforcing elements to the first and second commissure tabs, respectively, via stitching, the stitching extending over at least a portion of the first reinforcing element opposite a fold region of the support strip, and, for each commissure, securing end portions of the support strip to a respective support portion of a frame of the prosthetic heart valve.

Abstract: A belt for an implantable prosthetic device can include an annular body including a plurality of alternating peaks and valleys and a plurality of frangible members extending between at least one of adjacent peaks and adjacent valleys. The annular body can be radially expandable from a radially compressed configuration to a first diameter upon application of a radially outwardly directed force via an expandable implantable prosthetic device. A first frangible member of the plurality of frangible members can be configured to break when the radially outwardly directed force exceeds a first predetermined threshold to allow radial expansion of the annular body to a second diameter.

Abstract: An implantable prosthetic valve comprises an annular frame that is radially expandable from a radially compressed state to a radially expanded state. The frame has an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end. The prosthetic valve also comprises a plurality of leaflets positioned to regulate a flow of blood from the inflow end to the outflow end of the frame, and a skirt assembly. The skirt assembly comprises a laminate having a textile layer sandwiched between a first encapsulation layer and a second encapsulation layer. The first and second encapsulation layers are made of an elastomer and the textile layer comprises a first set of yarns and a second set of yarns interwoven with the first set of yarns, wherein the first and second sets of yarns are non-perpendicular and non-parallel to the longitudinal axis.

Abstract: An implantable prosthetic valve can include a frame movable between a radially compressed and a radially expanded configuration. The frame can include a first strut having a first locking feature disposed on a radially facing inner surface of the strut and a second strut having a second locking feature disposed on a radially facing outer surface of the strut. The first and second locking features can engage each other so as to allow pivoting of the first and second struts relative to one another in a first direction upon radial expansion of the frame and resist pivoting of the first and second struts relative to one another in a second direction to resist radial compression of the frame.

Abstract: A leaflet assembly for a prosthetic heart valve is disclosed. As one example, a method includes: forming a plurality of leaflet sub-assemblies, each including a leaflet and a skirt and formed by placing the skirt on one side of the leaflet such that the skirt extends along a curved cusp edge portion and two commissure tabs of the leaflet, folding two end portions of the skirt around corresponding commissures tabs, stitching each folded end portion to a corresponding commissure tab to form a respective half commissure portion, and stitching the skirt to the cusp edge portion and forming the leaflet assembly by pairing each half commissure portion of each leaflet sub-assembly with a half commissure portion of another leaflet sub-assembly to form a plurality of pairs of adjacent half commissure portions, and for each pair, stitching the adjacent half commissure portions to each other to form a commissure.

Abstract: 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.

Abstract: 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.

Abstract: 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.