Abstract: Embodiments of the present disclosure include apparatus for use at a native valve of a heart of a subject. A delivery tool has a shaft, a capsule disposed at a distal portion of the tool, and a balloon that is disposed within the capsule and coupled to the shaft. A tubular frame of a prosthetic valve is compressed around the balloon, such that shape-memory flanges of the prosthetic valve, and a shape-memory upstream support portion of the prosthetic valve, are each constrained within a respective capsule-portion of the capsule. The capsule is openable by moving the capsule-portions apart, such that the flanges and the upstream support portion automatically deflect radially outward, while the tubular frame remains compressed around the balloon, and inflation of the balloon plastically expands the tubular frame radially. 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: A delivery tool including a shaft and a proximal capsule and a distal capsule is dimensioned for percutaneous delivery to the heart. An open end of the proximal capsule faces the open end of the distal capsule. The capsules are coupled to the shaft in a manner that allows axial movement of the capsule with respect to the shaft. A prosthetic heart valve includes a tubular portion that defines a lumen and prosthetic leaflets disposed within the lumen. The prosthetic heart valve is restrainable in a compressed state by the delivery tool, such that a downstream end of the tubular portion is disposed within the distal capsule. The distal capsule is shaped so as to define an opening for visualizing ensheathing of at least a portion of the downstream end of the tubular portion within the distal capsule. Other embodiments are also described.

Abstract: A heart valve delivery system may be provided. The heart valve delivery system may include at least a first catheter movable relative to second and third catheters, arranged in a telescoping configuration. The second catheter may be movable relative to and extend from the distal end of the third catheter. The delivery system may include a first adjustable flexure radius associated with the second catheter, and a second flexure radius. The delivery system may include at one control handle assembly configured to permit the catheters to rotate together, independently adjust the first and second flexure radii, cause relative axial movement between the catheters, and permit the ejector to cause relative movement between a heart valve and a capsule connected to the first catheter.

Abstract: A prosthetic valve for implantation within a native heart valve may be provided. The prosthetic valve may include an annular valve body, as well as a plurality of ventricular anchoring legs and a plurality of atrial anchoring arms configured to extend radially outward from the annular valve body. The ventricular anchoring legs and grasping segments of the atrial anchoring arms may be configured to substantially restrict axial movement of the annular valve body within the native heart valve. In addition, anchoring segments of the atrial anchoring arms may be configured for lateral deformation relative to the native heart valve.

Abstract: A prosthetic heart valve, which may include an expandable annular outer frame having a tubular portion and at least one tissue anchor portion configured to extend from the tubular portion, may be provided. The at least one tissue anchor portion may have a plurality of attachment locations. The prosthetic heart valve may also include an expandable inner frame configured at least partially within the expandable annular outer frame. The expandable inner frame may be connected to the expandable annular outer frame solely at one or more of the plurality of attachment locations of the at least one tissue anchor portion.

Abstract: Apparatus is described that includes a blade assembly (20) for conditioning ex vivo pericardial tissue from which fibers extend. The apparatus includes a blade head (26) that includes a blade a may (28) and a face (30) defining gaps (32) therein. The gaps are dimensioned to facilitate protrusion therethrough of fibers into the blade head, such that movement of the blade array, with respect to the face, shears the fibers. The blade assembly is configured to be used while the tissue and the blade array are submerged in a liquid (140) with the fibers facing upward, and with the face facing downward. The apparatus is configured to provide, while the blade array is submerged in the liquid, a suction force that sucks the liquid into the blade head via the gaps, and discharges a refuse liquid through a lateral exhaust hole (24). 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, a plurality of atrial anchoring arms configured to extend radially outward from the annular valve body, and a plurality of ventricular anchoring legs configured to extend radially outward from the annular valve body. The arms may be configured to engage an atrial portion of the native mitral valve and the ventricular anchoring legs may be configured to engage a ventricular portion of the native mitral valve. The atrial anchoring arms and the ventricular anchoring legs may be positioned relative to each other such that when the atrial anchoring arms and ventricular anchoring legs engage the native mitral valve, a volume between the atrial anchoring arms and ventricular anchoring legs is configured to be substantially filled with tissue.

Abstract: A prosthetic valve delivery system may be provided. The prosthetic valve delivery system may include a first catheter and a first steering mechanism configured to bend the first catheter within a first steering plane. The prosthetic valve delivery system may also include a second catheter coaxially arranged within the first catheter and a second steering mechanism configured to bend the second catheter within a second steering plane, different from the first steering plane. Moreover, the prosthetic valve delivery system may include a capsule positioned distal to both the first catheter and the second catheter. The capsule may be configured to retain a prosthetic valve therein during transvascular advancement of the capsule.

Abstract: Apparatus and methods are provided including a mitral valve prosthesis. The prosthesis includes an inner support structure having downstream and upstream sections, the upstream section having a cross-sectional area greater than the downstream section. The inner support structure is configured to be positioned on an atrial side of the native valve complex, and to prevent the prosthesis from being dislodged into the left ventricle. A prosthetic valve having prosthetic valve leaflets is coupled to the inner support structure. An outer support structure has engagement arms, downstream ends of the engagement arms being coupled to the inner support structure. The prosthesis is configured such that, upon implantation thereof: downstream ends of the native valve leaflets, downstream ends of the engagement arms, and downstream ends of the prosthetic leaflets, are disposed at a longitudinal distance from one another of less than 3 mm. 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.

Abstract: A prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an annular valve body, a plurality of atrial anchoring arms configured to extend radially outward from the valve body, and a plurality of ventricular anchoring legs configured to extend radially outward from the valve body. The prosthetic valve may also include a blood-inflatable cuff situated between the arms and legs. The cuff may be configured to substantially fill a volume between the arms and the legs when the cuff is fully inflated with blood.

Abstract: Prosthetic valves and methods of implanting prosthetic valves may be provided, including an expandable prosthetic valve for implantation within a native heart valve. The prosthetic valve may include an annular valve body and atrial anchoring arms configured to extend radially outward from the annular valve body. Each atrial anchoring arm may have a proximal arm end and a distal arm end. The flexibility of at least one atrial anchoring arm may vary substantially from the proximal arm end thereof to the distal arm end thereof. The prosthetic valve may also include a plurality of ventricular anchoring legs configured to extend radially outward from the annular valve body. Each ventricular anchoring leg may have a proximal leg end and a distal leg end. Each ventricular anchoring leg may have a substantially constant flexibility from the proximal leg end to the distal leg end.

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 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: Heart valve prosthesis are disclosed that include a frame or support structure having an inflow portion, a valve-retaining tubular or central portion and a pair of support arms. The inflow portion radially extends from a first end of the valve-retaining tubular portion and the pair of support arms are circumferentially spaced apart and radially extend from an opposing second end of the valve-retaining tubular portion.

Abstract: A frame assembly (222) includes a tubular portion (32) that defines a lumen along an axis; a plurality of arms (46) coupled to the tubular portion at a first axial level, each of the arms extending radially outward from the tubular portion to a respective arm-tip; and a plurality of ventricular legs (50) that are coupled to the tubular portion at a second axial level, and that extend radially outward from the tubular portion. A first sheet (440) has a greater perimeter (446), and a smaller perimeter (448) that defines an opening. The first sheet is stitched onto the plurality of arms, with the opening aligned with the lumen. Subsequently, an outer perimeter (454) of a second sheet (450) is stitched to the greater perimeter of the first sheet. Subsequently, the second sheet is everted by passing an inner perimeter (452) of the second sheet around the arm-tips.

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: Embodiments of the present disclosure include apparatus for use at a native valve of a heart of a subject. A delivery tool has a shaft, a capsule disposed at a distal portion of the tool, and a balloon that is disposed within the capsule and coupled to the shaft. A tubular frame of a prosthetic valve is compressed around the balloon, such that shape-memory flanges of the prosthetic valve, and a shape-memory upstream support portion of the prosthetic valve, are each constrained within a respective capsule-portion of the capsule. The capsule is openable by moving the capsule-portions apart, such that the flanges and the upstream support portion automatically deflect radially outward, while the tubular frame remains compressed around the balloon, and inflation of the balloon plastically expands the tubular frame radially. Other embodiments are also described.

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.