Abstract: A tissue anchor (200, 258, 300) includes a shaft (122), a tissue-coupling element (128), and a flexible elongate tension member (202). The tissue-coupling element (128) includes a wire (150), which is shaped as an open loop (154) having more than one turn when the tissue anchor (200, 258, 300) is unconstrained. The tension member (202) includes a distal portion (204) that is fixed to a site (206) on the open loop (154), a proximal portion (208), which has a longitudinal segment (209) that runs alongside at least a portion (210) of the shaft (122), and a crossing portion (212), which (i) is disposed between the distal and the proximal portions (204, 208) along the tension member (202), and (ii) crosses at least a portion of the open loop (154) when the tissue anchor (200, 258, 300) is unconstrained.

Abstract: A tissue anchor system is provided that includes a first tissue anchor, a second tissue anchor that is separate and distinct from the first tissue anchor, and one or more tethers, which are configured to couple the first tissue anchor to the second tissue anchor. When the first tissue anchor is unconstrained, a head thereof is coaxial with an axis of a shaft thereof, and a tissue-coupling element thereof extends from a distal end of the shaft, is generally orthogonal to the axis, and is shaped such that if the tissue-coupling element were to be projected onto a plane that is perpendicular to the axis, at least 80% of an area of a projection of the tissue-coupling element on the plane would fall within a first angle of 180 degrees in the plane having a vertex at the axis. Other embodiments are also described.

Abstract: A suture fastener is provided that is shaped so as to define a spiral portion and a radially-inward portion that is disposed radially inward from the spiral portion. The suture fastener, when in a resting state, has an unlocked conical helical configuration, in which the spiral portion is conically helical. The suture fastener is configured, upon being axially plastically deformed, when one or more portions of one or more sutures pass through respective portions of the suture fastener, to transition from the unlocked conical helical configuration to a locked planar spiral configuration, in which the spiral portion is planar spiral and the one or more sutures are fixedly coupled to the suture fastener. The radially-inward portion is neither helical nor spiral, both when the suture fastener is in the unlocked conical helical configuration and when the suture fastener is in the locked planar spiral configuration. Other embodiments are also described.

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

Abstract: A surgical fastener instrument (30) includes an outer delivery tube (36); an inner delivery shaft (42), disposed at least partially in the outer delivery tube (36); and a handle (44) coupled to a proximal portion (46) of the outer delivery tube (36), and including a user control element (48) arranged to rotate the inner delivery shaft (42) with respect to the outer delivery tube (36). A suture fastener (32) is removably disposed in the outer delivery tube (36) in an unlocked conical helical configuration. Distal advancement of the inner delivery shaft (42), when one or more portions of one or more sutures (22) pass through respective portions of the suture fastener (32), transitions the suture fastener (32) from the unlocked configuration to a locked planar spiral configuration, in which the one or more sutures (22) are fixedly coupled to the suture fastener (32). Other embodiments are also described.

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 leaflet restraint (20) includes a non-blood-occlusive net (30), which is configured to at least partially cover an atrial surface (32) of a single native cardiac leaflet (34) of a native atrioventricular valve (36) of a heart (38). Two or more tissue-penetrating annulus anchors (40) are fixed to an annular side (42) of the net (30), and are configured to be anchored to an annulus (44) of the native atrioventricular valve (36) along or within 1 cm of a portion of the annulus (44) to which the single native cardiac leaflet (34) attaches. A ventricular anchor (50) is configured to be anchored to a ventricle (54) of the heart (58) so as to anchor a ventricular end (52) of the net (30) to the ventricle (54). The leaflet restraint (20) is configured, when anchored in place at least partially covering the atrial surface (32) of the single native cardiac leaflet (34), to limit prolapse of the single native cardiac leaflet (34) into an atrium (56) of the heart (38). Other embodiments are also described.

Abstract: A probe (24) is provided for use with an elongate medical instrument (20). The probe (24) is configured to be advanced through vasculature of a body of a subject, and includes a distal longitudinal probe-portion (26) and one or more loops (30). The one or more loops (30) are disposed along the distal longitudinal probe-portion (26) and are configured to be looped around a distal longitudinal medical-instrument-portion (28) of the elongate medical instrument (20) when the distal longitudinal probe-portion (26) is positioned at least partially alongside a distal longitudinal medical-instrument-portion (28) within the body, thereby mechanically coupling the distal longitudinal probe-portion (26) to the distal longitudinal medical-instrument-portion (28) within the body. The probe (24) is configured to bend the elongate medical instrument (20) within the body when the distal longitudinal probe-portion (26) is mechanically coupled to the distal longitudinal medical-instrument-portion (28).

Abstract: A split-frame cardiac valve (20) is configured to assume a radially compressed configuration for transcatheter delivery and a radially expanded configuration for anchoring to a native cardiac valve annulus. The split-frame cardiac valve (20) includes circumferential frame segments (22) including respective stents (24) and prosthetic leaflets (30). When the split-frame cardiac valve (20) is in the radially expanded configuration: (a) each of the stents (24) surrounds less than 360 degrees of a central longitudinal axis (26) of the split-frame cardiac valve (20), (b) the circumferential frame segments (22) are slidingly coupled to one another so as to be axially slidable with respect to one another in and out of axial alignment with one another, and (c) when the circumferential frame segments (22) are axially aligned with one another, the stents (24) collectively define a tubular stent (32) that entirely surrounds the central longitudinal axis (26).

Abstract: A valve-delivery-assist tool (20, 120, 220, 320) is provided for use during a transcatheter aortic valve implantation (TAVI) procedure on a native aortic valve. The valve-delivery-assist tool (20, 120, 220, 320) includes a delivery catheter (22); an aortic-valve cusp guide (24), which deflects laterally upon being released from the delivery catheter (22); and a conduction-tissue protector (26, 126), which includes a sheet (28, 128) and expands upon being released from a distal end (29) of the delivery catheter (22).

Abstract: Coaptation-assist devices (20) are provided for treating a native atrioventricular valve. The coaptation-assist devices (20) include a ventricular anchor (30), which includes one or more wires (35), and which is configured to be positioned in a ventricle; and a neo-leaflet (32), which is supported by the ventricular anchor (30) and is configured to at least partially replace function of a target native leaflet of the native atrioventricular valve by providing a surface of coaptation (34) for one or more opposing native leaflets. In some configurations, the ventricular anchor (30) includes a proximal subannular anchor (54), which includes a digitate anchor (56) that is shaped so as to define a plurality of fingers (60) having a plurality of curved superior peaks (66) that point in a superior direction and engage a subannular surface of the target native leaflet. Other embodiments are also described.

Abstract: A tissue anchor system is provided that includes a first tissue anchor, a second tissue anchor that is separate and distinct from the first tissue anchor, and one or more tethers, which are configured to couple the first tissue anchor to the second tissue anchor. When the first tissue anchor is unconstrained, a head thereof is coaxial with an axis of a shaft thereof, and a tissue-coupling element thereof extends from a distal end of the shaft, is generally orthogonal to the axis, and is shaped such that if the tissue-coupling element were to be projected onto a plane that is perpendicular to the axis, at least 80% of an area of a projection of the tissue-coupling element on the plane would fall within a first angle of 180 degrees in the plane having a vertex at the axis. Other embodiments are also described.

Abstract: A delivery system (10, 110) is provided for delivering and deploying an implantable balloon-based occlusion device (20) including an inflatable balloon (22). The delivery system (10, 110) includes a delivery handle (11), which includes a fluid-retaining chamber (41, 141); a plunger, which is slidingly disposed in the fluid-retaining chamber (41, 141); and a proximal rotatable user-control knob (31). A fluid-conveyance lumen catheter (18) defines a catheter fluid-conveyance lumen (19) in fluid communication with the fluid-retaining chamber (41, 141) and the inflatable balloon (22). A catheter lumen shaft (26) is in reversible connection with the balloon-based occlusion device (20), longitudinally slidable with respect to the delivery handle (11).

Abstract: An occluder device is provided for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue, the device including a compliant balloon defining a fluid-tight balloon chamber and a balloon channel forming a longitudinal passage from a proximal to a distal side of the balloon, the balloon including a fluid port for filling a fluid into the balloon chamber. A tip and a base are coupled to the distal and the proximal sides of the balloon, respectively. At least one connecting strut is attached to the tip and to the base. An elongate actuator is disposed longitudinally slidable in the balloon channel and connected to the tip, and longitudinally slidable with respect to the base so as to set a distance between the tip and the base. A lock is configured to maintain the distance between the tip and the base. Other embodiments are also described.

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 tissue anchor is provided that includes a head connected to a shaft, and a tissue-coupling element extending from the shaft. The shaft includes a seal that is configured to form a blood-tight seal between the shaft and a heart wall, and to promote hemostasis. When the tissue anchor is unconstrained, the head is coaxial with an axis of the shaft, and the tissue-coupling element is generally orthogonal to the axis and is shaped such that if the tissue-coupling element were to be projected onto a plane that is perpendicular to the axis, at least 80% of an area of a projection of the tissue-coupling element on the plane would fall within a first angle of 180 degrees in the plane having a vertex at the axis. Other embodiments are also described.

Abstract: A tissue anchor is provided for delivery by a deployment tool in a constrained state, the tissue anchor including a shaft; a tissue-coupling element, which includes a wire including a shape-memory alloy; and a flexible elongate tension member, which is distinct from the wire. The flexible elongate tension member includes a distal portion that is fixed to a site on the wire such that, when the tissue anchor is not constrained by the deployment tool, the flexible elongate tension member applies, to the tissue-coupling element, tension that constrains lateral expansion of the tissue-coupling element away from a central longitudinal axis of the shaft, by preventing the tissue-coupling element from automatically assuming a predetermined shape provided by the shape-memory alloy of the wire. Other embodiments are also described.

Abstract: An occluder device is provided for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue, the device including a compliant balloon defining a fluid-tight balloon chamber and a balloon channel forming a longitudinal passage from a proximal to a distal side of the balloon, the balloon including a fluid port for filling a fluid into the balloon chamber. A tip and a base are coupled to the distal and the proximal sides of the balloon, respectively. At least one connecting strut is attached to the tip and to the base. An elongate actuator is disposed longitudinally slidable in the balloon channel and connected to the tip, and longitudinally slidable with respect to the base so as to set a distance between the tip and the base. A lock is configured to maintain the distance between the tip and the base. Other embodiments are also described.

Abstract: A leaflet coaptation-assist device (920, 1020, 1120) is provided for promoting valve coaptation of leaflets (22) of an atrioventricular valve, the leaflet coaptation-assist device (920, 1020, 1120) including a coaptation-assist surface (964, 1064, 1164) and one or more tissue anchors, which are configured to anchor the leaflet coaptation-assist device (920, 1020, 1120) in place within the heart, such that the coaptation-assist surface (964, 1064, 1164) is located at or below the leaflet hinge line and contacts an atrial side of the leaflets (22) during ventricular systole, thereby enhancing leaflet coaptation. In some configurations, the one or more tissue anchors include one or more ventricular loops (988, 1088, 1188), which are configured to couple the leaflet coaptation-assist device (920, 1020, 1120) to the ventricular wall by radial force and friction. Other embodiments are also described.

Abstract: An instrument for repairing an atrioventricular heart valve, mitral heart valve or tricuspid heart valve includes a first tube having a tube axis defining an axial direction. A leaflet grabbing structure is arranged at a distal part of the first tube and contiguous to the first tube. The leaflet grabbing structure has a main body and a jaw, the jaw being movable relative to the main body. The jaw has a first proximally facing abutment surface and the main body has a second, distally facing abutment surface. The instrument has a needle that is cannulated and forms an inner tube. The needle is releasable from the first tube and movable relative to the main body in axial directions. The leaflet grabbing structure clamps a leaflet of the heart valve between the first and second abutment surfaces, while the jaw allows the needle to extend therethrough.