Abstract: An occlusion device (210) is provided for occluding a left atrial appendage (LAA), including a compliant balloon (230) defining a fluid-tight balloon chamber (232), and an actuating shaft (234), which is disposed at least partially within the balloon chamber (232) for setting a distance between distal and proximal end portions (236, 238) of the balloon (230). A proximal LAA-orifice cover (70) includes a frame (72) and a covering (74) fixed to the frame (72). An orifice-support stent (290) is fixed to and extends distally from the proximal LAA-orifice cover (70), and is generally cylindrical when in a radially-expanded state. Other embodiments are also described.

Abstract: A prosthetic valve includes a tubular portion coupled to an upstream support portion, and ventricular legs. The prosthetic valve is transitionable from a compressed state into a partially-expanded state in which (1) a downstream surface of the support portion defines (i) an annular concave region extending radially between a concave-region inner radius and a concave-region outer radius, and (ii) an annular convex region, radially outward from the annular concave region, extending radially between a convex-region inner radius and a convex-region outer radius, and (2) the tip of each leg is disposed radially between the concave-region inner radius and the concave- region outer radius. In a fully-expanded state each leg's tip is disposed radially between the convex-region inner radius and the convex-region outer radius. Other embodiments are also described.

Abstract: Apparatus and methods are described for treatment of a urethra that is constricted due to benign prostatic hyperplasia (BPH). A positioning device is used to determine a location of the area of the urethra that is constricted and is to be treated. An execution device includes a dilation balloon, a cutter, an implant carrier, and an implant, the implant and the implant carrier both being disposed outside the outer surface of the dilation balloon. The urethra is dilated by expanding the dilation balloon, and a cut is formed in the inner surface of the urethra using the cutter. The implant is released into the cut within the inner surface of the urethra subsequent to the cutter forming the cut in the inner surface of the urethra, to thereby maintain the urethra in a dilated state. Other embodiments are also described.

Abstract: The disclosure concerns systems for use in anastomosis of tubular biological organs within the body, particularly small tubular organs, such as blood vessels, bile duct, lymph duct, nerve ducts, epididymis, etc. The anastomosis system comprises a coupling device with a body, typically within a housing, a coupling assembly linked to the body, a plurality of suturing units within the coupling assembly, and an actuator arrangement formed within the coupling device.

Abstract: A valve frame includes a tubular portion defining a plurality of valve-frame coupling elements disposed circumferentially around a longitudinal axis of the valve frame, and a plurality of arms, extending radially outward from an upstream portion of the tubular portion to define an arm span, and configured to engage tissue in the atrium. An outer frame is coupled to the valve frame, and includes a ring circumscribing the tubular portion, and a plurality of flanges that extend radially outward from the ring to define a flange span, and are configured to engage ventricular tissue. Each arm defines a rigid portion and a flexible portion that is disposed radially outward from the rigid portion, and is more flexible than the rigid portion. The majority of the flexible portion is disposed further radially outward than the flange span. Other embodiments are also described.

Abstract: Embodiments of the present disclosure include a method for use at a native valve of a heart of a subject. At a distal portion of a delivery tool, a balloon is coupled to a shaft. The distal portion is advanced to the heart with an implant and the balloon disposed within a capsule. The implant includes a tubular frame and one or more shape-memory flanges. The tubular frame is compressed around the balloon, and the flanges are constrained within a downstream capsule-portion of the capsule. The flanges are exposed from the downstream capsule-portion such that the flanges automatically deflect radially outward. Subsequently, the flanges are pressed against a downstream surface of the native valve by moving the implant in an upstream direction. While the flanges are in contact with the downstream surface, the tubular frame is plastically expanded radially by inflating the balloon. Other embodiments are also described.

Abstract: An expandable prosthetic valve for implantation within a native heart valve may be provided. The prosthetic valve may include an expandable annular valve body. The valve body may include an atrial inlet opening and a ventricular outlet opening. The valve body may additionally include a plurality of tissue anchors extending from the valve body. The prosthetic valve may additionally include a flexible annular protective sleeve positioned about the rim of the valve body outlet opening and affixed to the outlet opening.

Abstract: A prosthetic valve is provided that includes a tubular valve body and a plurality of prosthetic leaflets disposed within a lumen of the valve body. The valve body includes struts, has an upstream end and a downstream end, and defines a lumen. The valve body is shaped so as to define a circumferential row of four-sided closed cells. Each of the four-sided closed cells is defined by some of the struts, which are shaped so as to collectively define the following four sides: a left upstream side, a right upstream side, a left downstream side, and a right downstream side. Exactly two of the four sides of each of the four-sided closed cells are double-strutted. Other embodiments are also described.

Abstract: A device for treating valvular regurgitation that includes an expandable anchor designed for transitioning from a linear configuration to a crown-like configuration through a radial expansion phase and an inversion phase. The expandable anchor is attached to a transvalvular spacer for providing a coaptation surface to valve leaflets.

Abstract: A unitary flexible sheet (612) is folded to define (i) a panel (608); (ii) a first tab (606a), having a first-tab outer layer and a first-tab inner layer, and protruding away from the panel; and (iii) a second tab (606b), having a second-tab outer layer and a second-tab inner layer, and protruding away from the panel. A commissural portion of a first prosthetic leaflet (58a), and a commissural portion of a second prosthetic leaflet (58b) are disposed between the first-tab inner layer and the second-tab inner layer. A first stitching (632) is stitched through the inner layer of each tab, and the commissural portion of each leaflet. A second stitching (634) is stitched through the outer and inner layers of each tab, and the commissural portion of each leaflet. The first-tab outer layer and the second-tab outer layer cover the first stitching. 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 and a plurality of atrial anchoring arms and a plurality of ventricular anchoring legs configured to extend radially outward from the annular valve body. The prosthetic valve may also include a blood-inflatable cuff situated between the arms and legs and fastened to at least one arm. The cuff may be configured to extend radially outward beyond a terminal end of at least one arm when fully inflated with blood.

Abstract: A surgical device is provided. The surgical device includes a housing adapted for mounting on a finger of a user; and at least one guide tube attached along a length of the housing. The guide tube is configured for guiding a tissue repair implant from a proximal opening to a distal opening thereof.

Abstract: A prosthetic valve is provided that includes a tubular valve body and a plurality of prosthetic leaflets disposed within a lumen of the valve body. The valve body includes struts, has an upstream end and a downstream end, and defines a lumen. The valve body is shaped so as to define a circumferential row of four-sided closed cells. Each of the four-sided closed cells is defined by some of the struts, which are shaped so as to collectively define the following four sides: a left upstream side, a right upstream side, a left downstream side, and a right downstream side. Each of the four sides of each of the four-sided closed cells is double-strutted. Other embodiments are also described.

Abstract: A method includes percutaneously advancing an implant to a native heart valve of a subject, the implant being housed in a compressed state within a delivery tool. Next, the method includes unhousing a longitudinally-intermediate portion of the implant, the longitudinally-intermediate portion being longitudinally between a longitudinally-proximal portion of the implant and a longitudinally distal portion of the implant. Subsequently, the longitudinally-proximal portion of the implant is unhoused. Subsequently, the longitudinally-distal portion of the implant is unhoused. By unhousing flanges of the implant, the flanges automatically expand. Upon the flanges expanding, a proximal end of each flange extends radially outward from a central longitudinal axis of the implant and longitudinally in a proximal direction. Other applications 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 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: 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: Embodiments of the present disclosure include apparatus including a percutaneous delivery capsule and prosthetic valve. The prosthetic valve includes a frame assembly that includes a tubular portion, and a plurality of atrial arms that extend away from the tubular portion. A plurality of prosthetic leaflets are attached to the tubular portion, and are disposed within a lumen defined by the tubular portion. When the prosthetic valve is in a compressed state and is housed by the capsule, each of the atrial arms extends, in a serpentine shape, along the capsule and away from the tubular portion. Other embodiments are also described.

Abstract: Apparatus and methods are described including a valve frame defining a frame aperture and at least one arm attached to a portion of the valve frame on a ventricular side of said frame aperture. The at least one arm is configured to extend radially from the portion of the valve frame such that a chord receiving surface of the arm is sized and shaped to deploy among a region of the chords of the native mitral valve. The arm is curved, with an interior of the arm facing a direction in which the valve frame is configured to be rotated during deployment of the prosthetic mitral valve apparatus within the native mitral valve and with the arm having a concavely rounded leading edge facing at least partially in a circumferential direction. Other applications 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: 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.