Abstract: Described herein are annular frames for prosthetic heart valves that include commissure portions that are radially offset and/or are radially flexible relative to the rest of the frame. The commissure portions can extend radially outwardly from the rest of the frame such that they are positioned at a greater radius than the adjacent struts of the frame. The commissure portions can be cantilevered from the frame, such that only one axial end of the commissure portion is attached to the rest of the frame, allowing the commissure portions to flex radially inwardly and outwardly relative to the rest of the frame. Lateral arms can also couple upper ends of the commissure portions to adjacent apices to pull them in at larger diameters. The radial position of the commissure portions relative to the rest of the frame can affect the positioning of the leaflets and the effectiveness of the valve.

Abstract: A prosthetic heart valve including a radially expandable and compressible annular frame and a plurality of leaflets attached to the frame is disclosed. The frame includes a plurality of interconnected struts defining a plurality of rows of cells arranged between a first end and a second end of the frame, the plurality of interconnected struts comprising a plurality of first struts defining the first end of the frame. The frame further includes a plurality of second struts axially offset from the first end of the frame, each second strut connected to and between two adjacent first struts of the plurality of first struts and extending axially away from the two adjacent first struts, where an inflow end of a cusp edge portion of each leaflet of the plurality of leaflets is secured to a corresponding second strut of the plurality of second struts.

Abstract: An anchoring system and related methods are provided for treatment of dilated hearts and of functional valve regurgitation, the system comprising one or more self-expandable or manually expandable anchors and associated devices for fixating a valve splint within the heart. For example, a spade-shaped assembly may be configured to be deployed in a right ventricle of the heart and to stabilize a puncturing instrument to puncture the septum. Various puncturing instruments may also be part of the anchoring system, including one or more of a flexible needle having a multiplicity of slits disposed along the length of the needle, a trocar catheter with a retractable head, and a catheter needle having a blunt introducer to protect nearby tissue within the heart during advancing a guidewire. A cutter catheter and puncture location catheter may also be part of the system and be used during treatment.

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: 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 prosthetic heart valve has a frame and a valvular structure supported by the frame. The frame has cells distributed circumferentially around the frame and formed by struts. The struts includes a support arm, which has a fixed end portion extending from an axial end portion of the frame and a free end portion disposed toward an opposite axial end portion of the frame relative to the fixed end portion. The fixed end portion has a rotational position that is rotationally offset relate to that of the free end portion. When the frame is in a radially-compressed configuration, a second locking member of the struts is spaced apart from a first locking member of the free end portion of the support arm. When the frame is in the radially-expanded configuration, the second locking member engages the first locking member, thereby restricting the frame from moving from the radially-expanded configuration.

Abstract: The present invention relates to implantable prosthetic devices, and more particularly, to 3D-shaped skirts having various coatings and/or configurations thereof.

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 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 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 docking station for a prosthetic heart valve includes a radially expandable and collapsible frame with a first plurality of struts, an inflow end portion, an outflow end portion, and a longitudinal axis. A sealing member is disposed on the outflow end portion and configured to form a seal between the docking station and a body lumen. The docking station further includes a valve seat coupled to the frame and configured to receive an expandable prosthetic valve. The valve seat includes a second plurality of struts coupled to the frame and extending in a downstream direction and angled inwardly toward the longitudinal axis of 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: An implantable prosthetic device can include a frame movable between a radially compressed configuration and a radially expanded configuration, and a valvular structure. The frame can have an inflow orifice, an outflow orifice, and one or more commissure windows. The valvular structure can include a plurality of leaflets, each leaflet having a main body with an inflow edge, an outflow edge, and a pair of opposing tabs. Each tab can be paired with an adjacent tab of an adjacent leaflet to form a commissure tab assembly, and each commissure tab assembly being coupled to a respective commissure window. Each tab can extend from the main body at an angle such that a radially outer edge of the tab corresponds to a draft angle of the frame.

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: 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: Expandable sheaths are disclosed herein. In some aspects, the sheath comprises at least one plurality of struts arranged to form an expandable cylindrical frame such that the formed frame is kink resistant. The disclosed frames are configured to expand from a first diameter d1 in an unexpanded position to a second diameter d2 an expanded position upon passage of a medical device, while maintaining the kink resistance. Also disclosed are methods of making the same.