Abstract: An implantable prosthetic device can include a radially expandable and compressible annular frame comprising an inflow end portion and an outflow end portion, and a plurality of leaflets arranged within the frame. Each leaflet can include one or more commissure tabs. The commissure tabs of two adjacent leaflets coupled to a commissure attachment member to form a commissure. The commissure can be secured to the frame via first and second sutures, each suture extending through a respective commissure tab, through the commissure attachment member, crossing over the other suture and being secured to the frame. The commissure can define a bending axis disposed radially inwardly of the frame such that a main body of each leaflet is prevented from contacting the frame when the valvular structure is in an open configuration.

Abstract: Coverings and/or skirts for prosthetic heart valves are disclosed. As an example, a prosthetic heart valve comprises a frame comprising three axially extending commissure support portions, a plurality of rows of angled struts including a first row defining an inflow end, a second row downstream of the first row, and a third row downstream of the second row and defining an outflow end, where downstream ends of the struts of the second row are connected to each other at junctions, and the commissure support portions extend from respective junctions to the third row of struts. The valve further comprises leaflets forming three commissures secured to respective commissure support portions, and an outer skirt comprising an outflow edge forming three circumferentially spaced projections aligned with the commissure support portions and covering respective junctions, the outflow edge comprising straight sections extending between adjacent projections upstream of the junctions.

Abstract: A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end and an outflow end, the frame comprising a plurality of struts defining openings between them, a valvular structure comprising a first leaflet including a first commissure tab and a second leaflet including a second commissure tab, and commissure attachment member. The commissure attachment member can be folded to define a central portion comprising a first surface and a second opposing surface, a first side portion extending from the first surface, and a second side portion extending from the first surface. The first and second commissure tabs can be disposed between and secured to the first and second side portions. The central portion and the first and second side portions of the commissure attachment member can be located inside 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 prosthetic valve is disclosed comprising an annular frame, a plurality of leaflets positioned within and coupled to the annular frame, each leaflet comprising a body portion having a free outflow edge and two opposing commissure portions on opposite sides of the leaflet, wherein each commissure portion is folded along a radially-extending fold line to form an inner fold layer and an outer fold layer, wherein each commissure portion is paired with a commissure portion of an adjacent leaflet to form a commissure that is coupled to the frame, and for each commissure, a retention member extending between the inner fold layer and the outer fold layer of a first commissure portion of the commissure and between the inner fold layer and the outer fold layer of a second commissure portion of the commissure to hold the first and second commissure portions together during working cycles of the prosthetic valve.

Abstract: Expandable frames for prosthetic heart valves are disclosed. As one example, a prosthetic valve can include a frame comprising interconnected angled struts defining rows of cells between first and second ends of the frame, the struts including a first row of struts at the first end, a second row of struts, and a third row of struts. A first row of first cells is disposed at the first end and defined by the first and second rows of struts and a second row of second cells is disposed adjacent to the first row of first cells and defined by the second and third rows of struts, each first cell wider than each second cell, and the second row of struts comprising a plurality of free apex regions, each connecting adjacent ends of a respective pair of angled struts and having a first surface with a constant convex curvature.

Abstract: Leaflets for a prosthetic heart valve are disclosed. As one example, a leaflet includes a main body with a free, outflow edge and a cusp edge portion, two lower tabs disposed on opposite sides of the main body, where the cusp edge portion terminates at upper ends thereof at the lower tabs, and the lower tabs extend laterally outward from the main body relative to a central longitudinal axis of the leaflet, and two upper tabs disposed on opposite sides of and extending laterally outward from the main body. The leaflet further includes two offsetting portions, each extending between a respective lower tab and upper tab and offsetting the respective upper tab axially and laterally away from the outflow edge of the main body, where each upper tab has opposing inner and outer edges that are parallel to one another and the central longitudinal axis of the leaflet.

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 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 implant for adding compliance to a blood vessel includes a first elongate rail shaped to contact an inner wall of a blood vessel and a second elongate rail shaped to contact an opposing inner wall of the blood vessel. Connectors extend between the first and second rails for providing a separation therebetween and maintaining the rails at locations on opposing sides of the lumen after implantation. The connectors push the rails outwardly for biasing the blood vessel toward a substantially oval shape. The connectors are preferably flexible for allowing the blood vessel to change shape during use for adding compliance to the blood vessel. The elongate rails are preferably curved or hemi-spherical for conforming to the shape of the inner wall of the blood vessel.

Abstract: A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end portion and an outflow end portion, the frame comprising a plurality of struts defining openings between them. The prosthetic valve can further include a valvular structure comprising a plurality of leaflets, each leaflet comprising a main body, opposing tabs on opposite sides of the main body, a coaptation edge portion, and a cusp edge portion. Each tab can be paired with an adjacent tab of an adjacent leaflet to form a plurality of commissures that are fixed relative to the frame, and each leaflet can have opposing edge portions between the opposing tabs and the cusp edge portion that are unattached to the frame, each unattached edge portion defining a gap that extends radially into the main body of the leaflet.

Abstract: A leaflet subassembly for a prosthetic heart valve can include a leaflet having a cusp edge portion and opposite major surfaces. A reinforcing structure can be attached to the leaflet along the cusp edge portion. The reinforcing structure can include a first reinforcing member and a second reinforcing member arranged on the opposite major surfaces of the leaflet. A prosthetic heart valve can include a frame and a leaflet subassembly. The leaflet subassembly can include a leaflet and a reinforcing structure attached to the leaflet along a cusp edge portion of the leaflet. The cusp edge portion can be coupled to the frame via the reinforcing structure. A method of assembling a prosthetic heart valve can include disposing a leaflet at least partially within a frame and attaching the leaflet to the frame by extending a suture through reinforcing members attached to opposite major surfaces of the leaflet.

Abstract: A prosthetic heart valve has an inner frame and an outer frame that is sutured to the inner frame. The outer frame has an atrial portion and a ventricular portion. The inner frame has a leaflet structure positioned between first and second ends of the metallic inner frame. The prosthetic heart valve has an inflow end and an outflow end, and is radially expandable and collapsible. The prosthetic heart valve has a plurality of tissue-engaging elements positioned along an exterior surface of the outer frame. The outer frame is configured such that in the expanded state the atrial portion of the outer frame extends upwardly beyond an inflow end of the inner frame, and a diameter of the outer frame increases from a first diameter at the outflow end of the prosthetic heart valve to a second diameter moving in an upstream direction toward the inflow end.

Abstract: Prosthetic valves that include support arms extending from support posts thereof, and methods for utilizing such prosthetic valves, are disclosed herein. As one example, a prosthetic valve can include an annular frame movable between a radially compressed state and a radially expanded state, and at least one support arm. The frame can include a plurality of support posts, each extending between a post inflow end and an opposite post outflow end. The support arm can extend from a corresponding support post, and terminate at a free-ended tip which is biased radially away from the corresponding support post.

Abstract: Outer skirts for a prosthetic heart valve are disclosed. As one example, a prosthetic heart valve can include an annular frame and an outer skirt disposed around an outer surface of the frame. The outer skirt can include a first portion comprising a polymeric material and a second portion comprising a fabric, where the polymeric material has a greater thromboresistance than the fabric.

Abstract: The present disclosure relates to prosthetic valves that include information indicators which can indicate suitable information associated with a previously implanted prosthetic valve. Such information indicators can be internally formed in relatively wide support posts of mechanically expandable prosthetic valve, or can be externally formed along support posts of mechanically expandable prosthetic valve or vertical struts of balloon expandable prosthetic valves.

Abstract: A prosthetic heart valve includes a valve frame comprising an outflow end and an inflow end, a plurality of leaflets disposed within and coupled to the valve frame, and a skirt assembly mounted to an outer surface of the valve frame. The skirt assembly includes a sealing layer and a skirt frame including a plurality of interconnected struts, wherein the skirt frame has a plurality of inflow apices and outflow apices, wherein selected ones of the inflow apices are fixed to the valve frame and selected ones of the outflow apices are fixed to the valve frame, wherein one or more of the struts are configured to flex in an outward radial direction when the valve frame is in a radially expanded state to cause the sealing layer to protrude outwardly from the valve frame.

Abstract: A prosthetic valve has an annular frame that is radially expandable and a leaflet structure positioned within the frame. The frame has an inflow end, an outflow end, a first row of angled struts defining the outflow end, a second row of angled struts upstream of the first row of angled struts, a third row of angled struts upstream of the second row of angled struts, and a plurality of axial frame members comprising respective first ends and second ends. The first ends are connected to the second row of angled struts and the second ends are connected to the third row of angled struts. The plurality of axial frame members include a plurality of axially extending commissure supports and one or more axial posts located between any two immediately adjacent commissure supports. Each commissure support is configured to support a corresponding commissure of the leaflet structure.

Abstract: A prosthetic heart valve can include a radially expandable and compressible annular frame, a valvular structure, and a commissure cover. The frame can include a plurality of struts defining the annular frame, and a plurality of commissure support structures each defining a commissure opening positioned along a circumference of the annular frame. The valvular structure can be mounted within the frame, the valvular structure including a plurality of commissures each extending radially through a respective commissure opening to attach the valvular structure to the frame, each commissure having an outflow edge that extends from a radial outer surface of the frame. The commissure cover can be disposed at least partially over the outflow edge of the commissure and can define a ramped surface that extends from the radial outer surface of the frame to a radial outer surface of the commissure.

Abstract: This disclosure is directed to prosthetic heart valves and actuation assemblies for prosthetic heart valves having actuators extending through actuation brackets secured to a prosthetic heart valve frame. In some examples, each actuator extends through and is pivotable relative to two actuation brackets secured to the inner surface of the prosthetic heart valve frame. In other examples, each actuator extends through and is pivotable relative to a vertically extending post of the frame. In this way, the actuators may move angularly relative to the longitudinal axis of the frame during the radial expansion and compression of the prosthetic heart valve. This may prevent bending and buckling of the actuators during the deployment of the prosthetic heart valve.