Abstract: An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration includes an annular frame including a plurality of angled strut members, a plurality of leaflets disposed within the frame and secured to the frame, and a skirt member secured to the frame. The skirt member is disposed about an edge portion of a leaflet of the plurality of leaflets, and the skirt member includes a plurality of extension portions wrapped around at least one strut member. A cord member is threaded through at least a portion of the plurality of extension portions in a direction along an axis of the at least one strut member to secure the skirt member to the at least one strut member.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A prosthetic heart valve includes a valve structure and a frame. The valve structure includes a plurality of leaflets, and the leaflets are configured to move from an open configuration to a closed configuration. The valve structure is coupled to the frame. The frame includes an inflow end, an outflow end, a longitudinal axis extending from the inflow end to the outflow end, and a plurality of struts forming a plurality of rows of cells. Each row of cells extends in a circumferential direction perpendicular to the longitudinal axis. Adjacent cells in a row of cell are coupled together at a junction of the struts defining the adjacent cells, and at least one junction in one row of cells has a shape that is different than at least one other junction of the one row of cells.

Abstract: A prosthetic heart valve including a radially expandable and compressible annular frame is disclosed. The frame includes a plurality of interconnected struts defining a plurality of rows of cells arranged between an inflow end and an outflow end of the frame, the interconnected struts comprising a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. The frame further includes a plurality of apex regions formed at the inflow end and the outflow end, each apex region curving between two angled strut portions and forming one of the outflow struts or one of the inflow struts with the two angled strut portions. Each apex region has a narrowed width and a length that extends along at least 25% of a total length of the outflow strut or inflow strut, the narrowed width smaller than a width of the two angled strut portions.

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: 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.

Abstract: 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.

Abstract: 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.

Abstract: An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration includes an annular frame having an inflow end, an outflow end, and a longitudinal axis. A leaflet structure is positioned within the frame and secured thereto, and a sealing element is secured to the frame. The sealing element includes a first woven portion extending circumferentially around the frame. The first woven portion includes a plurality of interwoven filaments. The sealing element 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. At least a portion of the filaments comprise a hydrophilic surface treatment.

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 comprises an annular frame comprising a plurality of interconnected struts, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state. A plurality of leaflets are situated within the frame, each leaflet comprising a main body, two opposing commissure tabs arranged on opposite sides of the main body and two opposing sub-commissure tabs arranged on opposite sides of the main body. Each commissure tab of a leaflet is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure that is coupled to the frame. Each sub-commissure tab is paired with an adjacent sub-commissure tab of an adjacent leaflet and connected thereto, wherein each pair of sub-commissure tabs extends radially inwardly relative to the frame.

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: A prosthetic valve includes a radially expandable and compressible annular frame and a valvular structure. The frame includes a first strut and an adjacent second strut that overlap at a pivot joint. Radial expansion or compression of the frame causes the first strut to pivot relative to the second strut at the pivot joint. The valvular structure includes first and second leaflets attached to the first and second struts with a suture. The first and second struts define four strut segments connected by the pivot joint. The suture comprises three interconnected locking knots that are respectively attached to three of the four strut segments.

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: 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.

Abstract: 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.

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 the plurality of leaflets, wherein each commissure is formed by pairing a first commissure tab of a first leaflet with an adjacent, second commissure tab of a second leaflet, and coupling a support strip to the first and second commissure tabs via sutures forming stitches along the support strip, and, for each commissure, securing the commissure to a respective support of a frame by forming one or more suture loops around an external surface of the support strip and the respective support of the frame, the suture loops being formed by end portion extensions of the sutures.

Abstract: A prosthetic heart valve comprises an annular frame that is radially compressible and expandable between a radially compressed state and a radially expanded state, wherein the frame elongates in an axial direction when radially compressed from the radially expanded state to the radially compressed state. Leaflets are coupled to the frame such that when the frame is in the radially expanded state, the leaflets have slack in an axial direction, wherein when the frame is radially compressed to a partially radially compressed state between the radially expanded state and the radially compressed state, the leaflets are in a relaxed state, and wherein when the frame is in the radially compressed state, the leaflets are stretched in the axial direction.