Abstract: An implantable prosthetic valve includes a radially collapsible and expandable annular frame having three commissure attachment portions and at least three rows of angled struts. The rows include a first row, a second row downstream of the first row, and a third row downstream of the second row. Each row of struts includes angled struts arranged in a zig-zag pattern defining a plurality of crowns. A leaflet structure includes three leaflets forming three commissures, each commissure being connected to one of the commissure attachment portions via sutures extending through apertures in the commissure attachment portions, wherein all of the apertures are located along the length of the frame between a first plane defined by the crowns of the second row of struts and a second plane defined by the crowns of the third row of struts.

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: 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: Apparatus (20) for testing a prosthetic leaflet (10) includes a bar (22); a light source (24); a detector (26); an actuator (40); a gauge (28); a display (82); and circuitry (84). The leaflet is draped over the bar. The light source emits a beam of light (32). The detector detects the beam, and generates a detection-signal indicative of detection of the beam. Actuation of the actuator moves the bar with respect to the beam. The gauge measures an elevation of the bar above the beam, the elevation changing with the moving of the bar by the actuator. The circuitry is configured: (i) to receive the measured elevation from the gauge, (ii) to receive the detection-signal from the detector, and (iii) in response to the detection-signal, to drive the display to display the elevation that was measured when the detection-signal was received by the circuitry.

Abstract: Apparatus includes a delivery tool and a prosthetic valve, the prosthetic valve includes a first frame, and a second frame coupled to the first frame. The delivery tool includes a first catheter, a second catheter, and a rod. A steerable portion of the second catheter extends out of the first catheter, and a steerable distal portion of the rod extends out of the second catheter. An extracorporeal rod-controller is operably coupled to the rod such that operating the extracorporeal rod-controller steers the steerable distal portion of the rod. In a delivery state of the apparatus, the prosthetic valve is compressed onto the rod, distal to the distal end of the second catheter, and the apparatus is transfemorally and transseptally advanceable into a left atrium of a heart of a subject. Other embodiments are also described.

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: An expandable prosthetic valve is implantable within a native mitral valve by terminal ends of ventricular anchors of the prosthetic valve moving outwardly from a constrained delivery position of the ventricular anchors, while the ventricular anchors are positioned within the atrium. Then, a portion of the expandable prosthetic valve containing the ventricular anchors is advanced through the native mitral valve into the ventricle. Terminal ends of atrial anchors of the prosthetic valve move outwardly relative to a portion of an annular valve body of the prosthetic valve while the atrial anchors are at least partially positioned within the atrium. Next, the annular valve body is radially expanded while the ventricular anchors are in the ventricle and the atrial anchors are in the atrium, thereby anchoring native heart valve tissue between the atrial anchors and ventricular anchors. 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: 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: Apparatus (20) for testing a prosthetic leaflet (10) includes a bar (22); a light source (24); a detector (26); an actuator (40); a gauge (28); a display (82); and circuitry (84). The leaflet is draped over the bar. The light source emits a beam of light (32). The detector detects the beam, and generates a detection-signal indicative of detection of the beam. Actuation of the actuator moves the bar with respect to the beam. The gauge measures an elevation of the bar above the beam, the elevation changing with the moving of the bar by the actuator. The circuitry is configured: (i) to receive the measured elevation from the gauge, (ii) to receive the detection-signal from the detector, and (iii) in response to the detection-signal, to drive the display to display the elevation that was measured when the detection-signal was received by the circuitry.

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: A valve body circumscribes a longitudinal axis and defines a lumen along the axis. Upstream arms are coupled to the valve body, and extend radially outward from the valve body to respective arm-tips. Downstream legs are coupled to the valve body, and extend radially outward from the valve body and toward the plurality of arms. A flexible pouch extends radially outward from the valve body. The arms and the legs narrow the pouch therebetween to form a narrowed portion of the pouch, thereby defining, in an interior space of the pouch: (a) an inner portion, radially inward from the narrowed portion, and in fluid communication with the lumen, and (b) an outer portion, radially outward from the narrowed portion, and in fluid communication with the inner portion via the narrowed portion. Other embodiments are also described.

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: Apparatus is described that includes a kit. The kit includes a flexible catheter (22) and a support (40). The catheter is transfemorally advanceable to a heart of a subject and the support is dimensioned for percutaneous access to the heart. The support has a proximal end, an elongate portion, and a distal portion (41) having a catheter-engaging element (38). The catheter-engaging element is configured to reversibly engage the catheter in a manner that does not inhibit longitudinal advancement of the catheter. Other embodiments are also described.

Abstract: During a medical procedure, a transseptal fenestration is made at a septum of the heart and a shunt is implanted into the transseptal fenestration. During the same medical procedure, a transapical puncture is made into a left ventricle of the heart. A prosthetic valve is delivered via the transapical puncture and implanted at a mitral valve of the heart. Subsequently to delivering the prosthetic valve and making the transseptal fenestration, the transapical puncture is closed. Other embodiments are also described.

Abstract: An implant includes a prosthetic valve and is transitionable from a compressed to an expanded state. The implant includes a frame assembly including a plurality of struts that collectively define an upstream-frame-assembly-perimeter at an upstream end of the frame assembly and a downstream-frame-assembly-perimeter at a downstream end of the frame assembly. The frame assembly includes a valve frame that defines a lumen, and one or more appendages disposed at and extending in a downstream direction from the downstream-frame-assembly-perimeter. A plurality of prosthetic leaflets are disposed within the valve frame lumen and facilitate one-way upstream-to-downstream fluid flow through the lumen. The implant includes a fabric and, in the expanded state of the implant, the fabric obscures the one or more appendages and defines a downstream perimeter of the fabric at a downstream end of the implant. Additional embodiments are 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: An apparatus for use at a native valve of a heart of a subject comprises a tubular frame (30) circumscribing a longitudinal axis to define a lumen, a valve member (62) disposed within the lumen and coupled to the tubular frame, an outer frame (40), and a pin (50). The outer frame is composed of a shape-memory alloy. The tubular frame and the pin are composed of a material that is not the shape-memory alloy. The outer frame comprises a flange (42), defines an eyelet (44), and is disposed radially outward from the tubular frame. The pin defines a shaft (52) and a head (54), and couples the outer frame to the tubular frame. The head is disposed against the outer frame, radially outward from the eyelet, the shaft extends from the head through the eyelet to the tubular frame, and the shaft is welded to the tubular frame.

Abstract: A rod (508) is transfemorally advanceable to the heart. An implant (460) comprises (i) a first frame (462), compressed around a first longitudinal site of a distal portion of the rod, (ii) a second frame (464), compressed around a third longitudinal site of the distal portion, (iii) a valve member (50), disposed within the second frame, and (iv) a flexible sheet (466), coupling the first frame to the second frame, and disposed around a second longitudinal site of the distal portion, the second longitudinal site being between the first longitudinal site and the third longitudinal site. An extracorporeal controller (569) is coupled to a proximal portion of the rod, and is operably coupled to the distal portion of the rod. Operating the controller bends the distal portion of the rod causing articulation between the frames. Other embodiments are also described.

Abstract: An expandable prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an expandable valve body having an atrial end, a ventricular end opposite the atrial end, and an intermediate portion extending between the atrial end and the ventricular end. The valve body may include a plurality of struts intersecting at junctions. The prosthetic valve may also include a plurality of tissue anchoring legs extending from junctions within the intermediate portion of the valve body. At least one of the tissue anchoring legs may have a cross-sectional area which is larger by at least 20% than a cross-sectional area of a strut extending between the at least one tissue anchoring leg and an adjacent tissue anchoring leg.