Abstract: A prosthetic heart valve comprises a radially collapsible and expandable annular frame and a leaflet structure comprising three leaflets. Each leaflet has an upper edge portion, a curved lower edge portion and two side flaps, wherein each side flap is connected to an adjacent side flap of another leaflet to form commissures of the leaflet structure, with each commissure being attached to the frame. An annular inner sleeve comprises three U-shaped portions positioned along the curved lower edge portions of the leaflets. An annular outer sleeve extends around are outer surface of the frame, wherein the outer sleeve is made of pericardium. The frame is made of Nitinol and the prosthetic valve can be radially crimped to a radially collapsed configuration inside a sheath for delivery into a patient's body and self-expand to a radially expanded configuration when released from the sheath inside the patient's body.

Abstract: A prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an annular valve body. The prosthetic valve may also include a plurality of tissue anchors arranged about the valve body and configured to extend from connection points on the valve body. The prosthetic valve may also include at least one protective fabric covering extending over each of the connection points between each tissue anchor and the valve body.

Abstract: In some embodiments, a valve prosthesis includes an inlet portion that is substantially s-shaped and configured to engage the floor of the outflow tract of the native heart atrium. In some embodiments, a valve prosthesis includes a chordae guiding element configured to reduce bending of the chordae to reduce stress on the chordae during the cardiac cycle. In some embodiments, a valve prosthesis includes a central portion having an hourglass shape configured to pinch a native annulus in order to provide axial fixation of the valve prosthesis within a valve site. In some embodiments, a valve prosthesis includes a frame having an outflow end that is flared to provide a gap between an outflow end of the frame and an outflow end of prosthetic leaflets when the prosthetic leaflets are fully opened.

Abstract: A unitary flexible sheet is folded to defines a panel, and first and second tabs. Each of the tabs has an inner layer and an outer layer. First and second prosthetic leaflets are coupled to a tubular frame via the sheet. Each of the leaflets has a respective commissural portion. For each of the commissural portions, a first region of the commissural portion is sandwiched between inner layers of the first and second tabs, and a second region of the commissural portion is disposed flat against the panel. Other embodiments are also described.

Abstract: Prosthetic valves and methods of use of prosthetic valves may be provided. In one implementation, a prosthetic valve may include an annular outer frame formed of struts intersecting at outer frame junctions, an inner frame situated within the outer frame and formed of struts intersecting at inner frame junctions, and a plurality of tissue anchors extending from the outer frame. The junctions along a downstream end of the outer frame may be spaced apart circumferentially from the junctions along a downstream end of the inner frame. The outer frame may include an anchor support strut extending between a downstream junction of the outer frame and a point of connection between one of the tissue anchors and the outer frame. The anchor support strut may be configured for placement parallel to a longitudinal axis of the prosthetic valve.

Abstract: Prosthetic valves and methods of use of prosthetic valves may be provided. In one implementation, a method of implanting a prosthetic valve within a native heart valve may be provided. The method may include delivering the prosthetic valve into a heart chamber while the prosthetic valve is constrained in a radially-contracted delivery configuration. The method may also include unconstraining ventricular tissue anchors and atrial tissue anchors of the prosthetic valve while maintaining an annular valve body of the prosthetic valve in the delivery configuration. The method may also include unconstraining the annular valve body from the delivery configuration while the unconstrained atrial tissue anchors and ventricular tissue anchors are positioned within an atrium and a ventricle, respectively. Unconstraining the annular valve body may decrease a longitudinal distance between the ventricular tissue anchors and atrial tissue anchors to secure the prosthetic valve within the native heart valve.

Abstract: Prosthetic valves and methods of implanting prosthetic valves may be provided, including a prosthetic valve for implantation within a native heart valve. The prosthetic valve may include an annular valve body, a plurality of atrial anchoring arms, and a plurality of ventricular anchoring legs. The arms and legs may extend radially outward from the annular valve body and may each include a native valve tissue engaging portion. The arms may be angularly offset from the legs, with the tissue engaging portion of each arm and each leg arranged such that when the arms and legs are positioned on opposing sides of native heart valve tissue, the native heart valve tissue may assume a serpentine arrangement between the arms and the legs.

Abstract: Apparatus is provided for use with a heart of a subject, the apparatus including an inner stent frame defining a tubular portion, and an outer stent frame. The apparatus has a relaxed expanded state in which an outer-stent-frame relaxed expanded diameter defined by the outer slept frame is smaller than an inner-stent-frame expanded diameter defined by the tubular portion. Together, the inner stent frame and the outer stent frame define a frame assembly in which outer-frame coupling elements are fixed to inner-frame coupling elements. The frame assembly is expandable into an expanded state in which the tubular portion defines an inner-stent-frame constrained expanded diameter that is smaller than the inner-stent-frame relaxed expanded diameter. The frame assembly includes prosthetic leaflets secured to, and disposed within, the tubular portion, and has a compressed state in which the frame assembly is transluminally advanceable to the heart. Other embodiments are also described.

Abstract: Prosthetic valves and methods of use of prosthetic valves may be provided. In one implementation, a method of releasing a prosthetic valve from a delivery capsule within a heart may be provided. The delivery capsule may include a distal capsule portion and a proximal capsule portion. The method may include moving the distal capsule portion in a first direction to release ventricular anchoring legs of the prosthetic valve from the delivery capsule and moving the released legs into contact with a native mitral valve. The method may include moving the proximal capsule portion in a second direction to release atrial anchoring arms of the prosthetic valve from the delivery capsule, after contacting the mitral valve with the released legs. The method may include moving the distal capsule portion in the first direction to release an annular valve body of the prosthetic valve from the delivery capsule.

Abstract: An assembly (10) for crimping a frame (56) of an implant (58) comprises a crimping device (20) with a base (22) and a crimping mechanism (24) that defines a crimping aperture (26). A bath (28) having a floor (30), and one or more side-walls (32) extending upward from the floor to a side-wall height defines a receptacle (18) that is shaped to receive a portion of the crimping device. The apparatus has an assembled state in which the portion of the crimping device has been received by the receptacle, the crimping device is held securely by the bath, and the aperture is below the side-wall height. Other embodiments are also described.

Abstract: A prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an annular valve body. The prosthetic valve may also include a plurality of tissue anchors arranged about the valve body and configured to extend from connection points on the valve body. The prosthetic valve may also include at least one protective fabric covering extending over each of the connection points between each tissue anchor and the valve body.

Abstract: A method is provided, including (1) identifying the subject as having mitral valve regurgitation; (2) during a medical procedure, in response to identifying the subject as having mitral valve regurgitation, implanting a prosthetic valve at a mitral valve site of the heart; and (3) during the same medical procedure, implanting a therapeutic septal device at a septum of the heart. Other embodiments are also described.

Abstract: Prosthetic heart valves and methods of use of prosthetic heart valves may be provided. In one implementation, a prosthetic heart valve configured to transition between radially compressed and radially expanded configurations may be provided. The prosthetic heart valve may include an outer frame, an inner frame, and at least one tissue anchor extending from at least one of the frames. The prosthetic heart valve may be configured to maintain a first distance between the downstream ends of the inner and outer frames when the prosthetic heart valve is in the radially compressed configuration and a second distance between the downstream ends of the inner and outer frames when the prosthetic heart valve is in the radially expanded configuration, the first distance being greater than the second distance.

Abstract: Prosthetic heart valves and methods of use of prosthetic heart valves may be provided. In one implementation, a prosthetic heart valve may include an annular valve body and atrial anchors and ventricular anchors extending from the valve body. An atrial anchor may include a pivoting portion configured to extend in an upstream direction when the prosthetic heart valve is in a delivery configuration and in a downstream direction when the prosthetic heart valve is in a deployed-anchor configuration. A portion of a ventricular anchor may be configured to abut the annular valve body when the prosthetic heart valve is arranged in the delivery configuration.

Abstract: A unitary flexible sheet is folded to defines a panel, and first and second tabs. Each of the tabs has an inner layer and an outer layer. Commissural portions of prosthetic leaflets are sandwiched between inner layers of the first and second tabs. The tabs protrude from a first side of the panel, and are shaped such that progressively downstream parts of each tab protrude progressively further away from the panel portion. Other embodiments are also described.

Abstract: A prosthetic valve leaflet is placed across a bar, and the bar is positioned such that the leaflet drapes over the bar and blocks a beam of light emitted by a light source. While the leaflet remains draped over the bar, the bar is elevated at least until the leaflet stops blocking the beam. An elevation of the bar from the beam at which the leaflet stopped blocking the beam is identified. Other embodiments are also described.

Abstract: Prosthetic valves and methods of use of prosthetic valves may be provided. In one implementation, a prosthetic valve may include an annular outer frame, an inner frame, and a plurality of ventricular anchoring legs extending from the outer frame. The outer frame may be formed at least partially of struts intersecting at junctions. At least one ventricular anchoring leg may include a first curved leg portion on a first surface of the leg, and a second curved leg portion on a second, opposite surface of the leg. The outer frame may also include a strut extending between a downstream end of the outer frame and the junction from which the at least one ventricular anchoring leg extends.

Abstract: Apparatus is provided including a percutaneously-implantable implant and an adjustment device. The adjustment device can comprise an adjustment mechanism, coupled to the implant, and configured to change a dimension of the implant upon actuation of the adjustment mechanism and a lock. The adjustment device can have a locked state in which the lock inhibits actuation of the adjustment mechanism and an unlocked state in which the adjustment mechanism is actuatable. The adjustment device can be reversibly movable between the locked state and the unlocked state. The apparatus can include a longitudinal guide member and an adapter. An unlocking mechanism can be configured such that, while the adapter is coupled to the adjustment device, actuation of the unlocking mechanism moves the lock between the locked state and the unlocked state. Other applications are also described.

Abstract: Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, a prosthetic valve may include an annular outer frame formed at least partially of struts intersecting at outer frame junctions and an inner frame situated within the outer frame. The inner frame may be formed at least partially of struts intersecting at inner frame junctions. The valve may include at least one inner frame tissue anchor extending from an inner frame junction. Outer frame junctions along a ventricular end of the outer frame may be angularly offset from inner frame junctions along a ventricular end of the inner frame.

Abstract: A valve frame is shaped to define a plurality of atrial arms, and a tubular portion that defines a lumen along a longitudinal axis of the valve frame. Prosthetic leaflets within the lumen are coupled to the frame. An outer frame defines a ring and a plurality of ventricular legs coupled to the ring. The ring circumscribes the tubular portion, and is defined by a pattern of alternating peaks and troughs. The tubular portion defines a row of upstream cells, and a row of downstream cells that is tessellated with the row of upstream cells. Each of the atrial arms is attached to, and extends from, a respective connection site at which adjacent upstream cells are connected to each other. Other embodiments are also described.