Abstract: Devices, assemblies, and methods for displacement of leaflets surrounding a prosthetic valve, such as native leaflets or host leaflets of a previously-implanted prosthetic valve, during valve implantation procedures are disclosed herein. As one example, a valve assembly can include a prosthetic valve and a leaflet engagement frame coupled to the frame of the prosthetic valve. The leaflet engagement frame can include a plurality of engagement frame struts defining one or more rungs, and a plurality of spikes that extend in a distal direction from a first rung of struts of the leaflet engagement frame. The distally extending spikes are configured to engage with one or more native or host leaflets positioned outside the valve assembly when the valve assembly is in a partially expanded state, and to distally fold the engaged native or host leaflets when the valve assembly is further expanded.

Abstract: Disclosed herein are implantable medical devices comprising a textile material comprising a first material and a second material having different stretchability and flexibility, where the first and the second materials are at least partially superposed and coupled to each other. The medical devices of the current disclosure can be implantable prosthetic valves. The valves of the present disclosure provide for a reduced crimped profile and improve PVL sealing. In addition, disclosed herein are methods of making the implantable medical devices.

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 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: 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.

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: 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: 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.

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: Methods and tools for implanting prosthetic heart valves and modifying leaflets of an existing valvular structure in a subject are disclosed herein. Prior to or during implantation of the prosthetic heart valve within the existing valvular structure, each tool can be provided in the ascending aorta (or equivalent thereof) of a subject and can be used to pierce, lacerate, slice, tear, cut or otherwise modify a leaflet or commissure of the existing valvular structure. The existing valvular structure can be a native aortic valve or other native heart valve, or a previously-implanted prosthetic heart valve. The modification can avoid, or at least reduce the likelihood of, issues that leaflets of the existing valvular structure might otherwise cause once the prosthetic heart valve has been fully installed, for example, obstruction of blood flow to the coronary arteries and/or improper valve mounting due to a non-circular cross-section.

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: 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.