Abstract: An implantable prosthetic valve comprises a radially collapsible and expandable annular frame and a leaflet structure that regulates the flow of blood through the prosthetic valve. A fabric inner skirt is positioned along an inner surface of the frame. The inner skirt comprises a first set of yarns extending in a first direction and a second set of yarns extending in a second direction and woven with the first set of yarns. The yarns of the first set are thinner than the yarns of the second set and are woven with the second set of yarns such that an inner surface of the skirt is formed from more of the yarns of the first set than the yarns of the second set and an outer surface of the skirt is formed from more of the yarns of the second set than the yarns of the first set.

Abstract: An implantable prosthetic valve can include a radially expandable and collapsible annular frame having an inflow end and an outflow end. A valvular structure can be positioned within the frame. A plurality of sealing members can be positioned around an outer surface of the frame, wherein the sealing members are configured to transform from an unfurled configuration extending along the outer surface of the frame when the frame is in the radially collapsed configuration to a coiled configuration when the frame is radially expanded to the radially expanded configuration.

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: In one representative embodiment, a gripping and pushing device for a medical instrument comprises an elongated main body defining a lumen. The elongated main body comprises one or more deflectable portions that can be pressed radially inwardly toward a shaft of the medical instrument extending through the lumen. One or more elastomeric gripping layers can be secured to the inner surface of a respective deflectable portion at axially spaced apart attachment locations. The one or more gripping layers are axially deformable relative to the one or more deflectable portions between the attachment locations when manual pressure is applied to the one or more deflectable portions to press the one or more gripping layers against the shaft and move the shaft longitudinally into a patient's body.

Abstract: Various mechanically expandable prosthetic heart valves, as well as deliver apparatus, delivery assemblies, and methods for implanting such prosthetic heart valves. In one example, a prosthetic heart valve includes a mechanically expandable frame, a valve structure, and an actuator. The frame includes a plurality of struts and is movable between a radially compressed state and a radially expanded state. The valve structure includes a plurality of leaflets. The actuator is coupled to the frame and comprises an actuation lumen, a locking member, and a locking element. The actuation lumen is circumferentially spaced and axially parallel to the locking member. The actuation lumen is configured for receiving an axially movable actuation shaft that can move the frame between the radially compressed state and the radially expanded state. The locking element is rotatably coupled to the locking member and is configured to lock the frame at a desired state.

Abstract: An implantable prosthetic valve includes a radially collapsible and expandable annular frame having three commissure attachment posts and four rows of circumferential struts. The rows include a first row, a second row downstream of the first row, a third row downstream of the second row, and a fourth row downstream of the third row and defining an outflow end of the frame. Each row of circumferential struts includes angled struts arranged in a zig-zag pattern. A leaflet structure includes three leaflets forming three commissures, each commissure being connected to one of the commissure attachment posts only at locations along the commissure attachment posts between a first plane that is perpendicular to a longitudinal axis of the frame and intersects crowns of the third row of struts and a second plane that is perpendicular to the longitudinal axis and intersects crowns of the fourth row of struts.

Abstract: Disclosed herein are embodiments of a balloon shaped to have one or more enlarged recons to selectively increase expansion forces on an implant. For example, the balloon may have a central portion that is enlarged to exert more force on the center of a stent-mounted prosthetic heart valve. This overcomes the stent-mounted prosthetic heart valve's tendency to expand with flared ends. This forms a more cylindrical or barrel shaped stent frame during expansion of the balloon—reducing or eliminating the instance wherein the cylindrical stent frame has flared ends. Alternatively, the balloon may have conical flares placed to cause or enhance flared ends of the cylindrical implant to enhance its anchoring capabilities.

Abstract: An implantable prosthetic valve can include an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. A leaflet structure can be positioned within the frame and secured thereto. An outer skirt can be positioned around an outer surface of the frame and secured to the frame and an annular sealing member can be positioned around an outer surface of the outer skirt and secured to the outer skirt.

Abstract: In one representative embodiment, a gripping and pushing device for a medical instrument comprises an elongated main body defining a lumen. The elongated main body comprises one or more deflectable portions that can be pressed radially inwardly toward a shaft of the medical instrument extending through the lumen. One or more elastomeric gripping layers can be secured to the inner surface of a respective deflectable portion at axially spaced apart attachment locations. The one or more gripping layers are axially deformable relative to the one or more deflectable portions between the attachment locations when manual pressure is applied to the one or more deflectable portions to press the one or more gripping layers against the shaft and move the shaft longitudinally into a patient's body.

Abstract: A method of assembling a prosthetic heart valve comprises securing a suture loop having at least first and second windings to an outflow edge portion of an inner skirt. The first and second windings are arranged in a repeating pattern of figure-eight shape curves and each winding has a plurality of first sections attached to the outflow edge portion of the inner skirt and a plurality of second sections unattached to the inner skirt. The inner skirt is placed inside of an annular frame and the second sections of the first and second windings are placed over apices of an outflow end of the frame such that the second sections of the first and second windings reside outside of the frame. The second sections of the windings are inserted inwardly through openings in the frame and attached to selected locations on the inner skirt.

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 method of crimping an implantable prosthetic valve can include placing protective material over at least a portion of the implantable prosthetic valve. The protective material can be configured to occupy space between open cells of a frame of the implantable prosthetic valve to prevent damage to a leaflet structure of the implantable prosthetic valve. The method can also include crimping the implantable prosthetic valve with the protective material on the implantable prosthetic valve, and removing the protective material from between the frame and the leaflet structure of the implantable prosthetic valve.

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 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: Embodiments of a radially collapsible and expandable prosthetic heart valve and method for crimping the prosthetic heart valve are disclosed. A method of radially compressing a prosthetic valve can include partially inserting the valve while in a radially expanded configuration into a crimping device comprising crimper jaws, wherein a portion of the valve comprising an outer skirt extends outside of the crimper jaws. The method can further include crimping the valve to a first partially collapsed configuration, further inserting the valve into the crimping device, such that the outer skirt is between the crimper jaws, and crimping the valve to a second partially collapsed configuration, wherein a diameter of the valve is smaller in the second partially collapsed configuration than in the first partially collapsed configuration.

Abstract: A prosthetic heart valve includes a frame, a valvular structure, and a skirt. The frame is movable between collapsed and expanded configurations and includes struts disposed between inflow and outflow ends, apices disposed at the inflow end formed by intersections of two or more struts, and junctions disposed between the apices and the outflow end and formed by intersections of two or more struts. The apices are circumferentially offset from the junctions. The valvular structure is positioned within and secured to the frame. The skirt is secured to the frame and includes a first edge portion and a second edge portion. The first edge portion is secured to the frame at the apices. The second edge portion is secured to the frame at the junctions. The skirt is configured to retract inwardly between the apices when the frame is moved from the radially expanded configuration to the radially collapsed configuration.

Abstract: A prosthetic valve includes an annular frame and a skirt. The frame is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The skirt has a fold around an inflow end of the frame so as to cover at least a portion of an outer surface of the frame and at least a portion of an inner surface of the frame. When the frame is in the radially expanded configuration, an outer portion of the skirt tightly conforms to the outer surface of the frame and the inflow end of the frame is axially spaced from the fold to form an axially extending gap between the frame and the fold. When the frame is in the radially compressed configuration, the inflow end of the frame extends axially so as to at least partially fill the axially extending gap.

Abstract: An implantable prosthetic valve can include an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. A leaflet structure can be positioned within the frame and secured thereto. An annular sealing member can be positioned around an outer surface of the frame, wherein the sealing member has a periodic, undulating shape. An outer skirt can be positioned around an outer surface of the sealing member and secured 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: 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.