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 first part of an annuloplasty structure is anchored to an annulus of a valve of a heart by using a driver to screw a tissue-coupling element of a first anchor into a first site of the annulus, such that the tissue-coupling element enters cardiac tissue in a direction parallel to a central longitudinal axis of the driver through the distal end of the anchor driver. The same is subsequently done for second and third parts of the annuloplasty structure using second and third anchors at second and third sites of the annulus, mutatis mutandis. Between anchors, the driver is retracted out of the heart. Subsequently, the valve is treated by reducing a distance between the first site and the second site, and a distance between the second site and the third site, by tightening a flexible and elongate contracting member of the annuloplasty structure.

Abstract: A method treating a deficient native mitral valve includes advancing the distal end portion of a delivery catheter into a heart, wherein the delivery catheter contains a support band stretched into a linear form, wherein the support band comprises a shape-memory material, and then ejecting the support band from the distal end portion of the delivery catheter such that the support band transitions from the linear form to a curved shape extending around native leaflets of the native mitral valve.

Abstract: A method is provided that includes implanting a first tissue-engaging element in a first portion of tissue in a vicinity of a heart valve. A second tissue-engaging element, which is connected to a third tissue-engaging element by a longitudinal sub-member, is implanted in a second portion of tissue of an annulus, and the third tissue-engaging element is implanted in a third portion of tissue of the annulus. A fourth tissue-engaging element is implanted in a portion of a blood vessel that is in contact with an atrium. While the longitudinal sub-member engages the longitudinal member at a junction therebetween, at least a first leaflet of the heart valve is drawn toward at least a second leaflet of the heart valve by adjusting a distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve. Other embodiments are also described.

Abstract: A method of reducing tricuspid valve regurgitation is provided, including implanting first, second, and third tissue anchors at respective different first, second, and third implantation sites in cardiac tissue in the vicinity of the tricuspid valve of the patient. The geometry of the tricuspid valve is altered by drawing the leaflets of the tricuspid valve toward one another by applying tension between the first, the second, and the third tissue anchors by rotating a spool that (a) winds therewithin respective portions of first, second, and third longitudinal members coupled to the first, the second, and the third tissue anchors, respectively, and (b) is suspended along the first, the second, and the third longitudinal members hovering over the tricuspid valve away from the annulus of the tricuspid valve. 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: 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: 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: Apparatus for puncturing a fossa ovalis includes a catheter shaped so as to define a central catheter lumen open through a catheter distal end opening. An angle between (i) a first line running between first and second lateral openings defined by the catheter and (ii) a second line that is parallel to a central longitudinal axis of the catheter when the catheter is straight, is between 30 and 150 degrees. A flexible longitudinal member passes (a) from a proximal portion of the catheter to a distal portion of the catheter, (b) out of the first lateral opening, and (c) into the second lateral opening, so as to form a loop outside the catheter. The flexible longitudinal member is configured to assume a deployment configuration in which a distal-most portion of the loop is curved and is distal to the catheter distal end opening. Other embodiments are also described.

Abstract: A suture-securing device includes a first tubular element, shaped to define a first lumen therethrough, and having first and second ends; and a second tubular element, shaped to define a second lumen therethrough, and having first and second ends. The suture-securing device is configured to have (a) an unlocked configuration in which the first end of the second tubular element is disposed closer to the first end of first tubular element than is the second end of the second tubular element, and the sutures are disposable within and slidable through the first and second lumens, and (b) a locking configuration in which the second end of the second tubular element is disposed closer to the first end of first tubular element than is the first end of the second tubular element, and the sutures are inhibited from sliding through the first and second lumens. Other embodiments are also described.

Abstract: Prosthetic valve systems for treating a native valve exhibiting regurgitation can include a support structure in which a separate prosthetic heart valve can be placed. A method for implant a prosthetic valve system can include advancing a first catheter delivery sheath through an introducer sheath and into a left ventricle of a patient's heart, deploying at least a portion of a support structure from the first catheter delivery sheath and positioning the support structure around native leaflets of the patient's native mitral valve, positioning a prosthetic heart valve in a radially collapsed configuration within the patient's native mitral valve, and expanding the prosthetic heart valve from the radially collapsed configuration to a radially expanded configuration, wherein the prosthetic heart valve contacts the native leaflets from within the patient's native mitral valve and is separated from the support structure by the native leaflets.

Abstract: An occlusion device (20) includes a compliant balloon (5) including an inflation port (3) for filling and unfilling a fluid into and from a balloon chamber (26). A distal tip element (10) and a proximal base element (4) are disposed at distal and proximal sides (28B, 28A) of the balloon (5), respectively. An elongate actuating element (9) is disposed longitudinally slidable in a balloon lumen (6) forming a longitudinal passage (27) from the proximal side (28A) to the distal side (28B) of the balloon (5), connected to the distal tip element (10), and longitudinally moveable with respect to the proximal base element (4) so as to set a distance between the distal tip element (100 and the proximal base element (4). A locking mechanism (2) is configured to maintain, between the distal tip element (10) and the proximal base element (4), the distance set using the elongate actuating element (9).

Abstract: A method of implanting a prosthetic mitral valve includes advancing a delivery apparatus into a left side of a patient's heart and deploying a support structure from the delivery apparatus. The support structure extends around native mitral valve leaflets such that the native leaflets are disposed radially within the support structure. The method also includes advancing a prosthetic heart valve within the native leaflets. The prosthetic heart valve is separate from the support structure and includes an annular frame and a valve structure positioned within the annular frame, and prosthetic heart valve is in a radially collapsed configuration. The method further includes expanding the prosthetic heart valve from the radially collapsed configuration to a radially expanded configuration. In the radially expanded configuration, the annular frame of the prosthetic heart valve engages the native leaflets and is separated from the support structure by the native leaflets.

Abstract: An occluder device (20) for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue comprises:—a compliant balloon (5) defining a fluid-tight balloon chamber and provided with a balloon channel (7) forming a longitudinal passage from a proximal side (B2) to a distal side (B1) of the balloon; —a tip element (10) disposed at the distal side of the balloon, a base element (4) disposed at the proximal side of the balloon, and connecting means comprising at least one connecting stmt (9) attached to the tip element and to the base element, the tip element and the base element each having a guide opening (105a, 105b) substantially coaxial to the balloon channel (7) for slidingly receiving therein a guidewire (106) for the device; —elongated actuating means disposed longitudinally slidable in the balloon channel (7), releasably connectable to the tip element (10), and longitudinally slidable with respect to the base element (4); —locking means (2, 13) for maintaining a predetermin

Abstract: Prosthetic valve systems for replacing a native valve exhibiting regurgitation include a support structure and a transcatheter heart valve (THV) that is separate from the support structure. The support structure can be configured to be positioned such that it extends annularly around the native valve leaflets. After the support structure is deployed around the native valve leaflets, the THV can be expanded within the support structure such that the native valve leaflets are engaged between the support structure and the THV.

Abstract: A first part of an annuloplasty structure is anchored to an annulus of a valve of a heart by using a driver to screw a tissue-coupling element of a first anchor into a first site of the annulus, such that the tissue-coupling element enters cardiac tissue in a direction parallel to a central longitudinal axis of the driver through the distal end of the anchor driver. The same is subsequently done for second and third parts of the annuloplasty structure using second and third anchors at second and third sites of the annulus, mutatis mutandis. Between anchors, the driver is retracted out of the heart. Subsequently, the valve is treated by reducing a distance between the first site and the second site, and a distance between the second site and the third site, by tightening a flexible and elongate contracting member of the annuloplasty structure.

Abstract: A method is provided for puncturing a fossa ovalis of a heart, the method including inserting a catheter into a right atrium of the heart, and advancing a distal portion of the catheter toward an interatrial septum of the heart. A flexible longitudinal member is slid through openings disposed at the distal portion of the catheter, such that the flexible longitudinal member is made to loop around a portion of an inside perimeter of the fossa ovalis. While the flexible longitudinal member is looped around the portion of the inside perimeter of the fossa ovalis, a hole is punctured in the fossa ovalis at a puncturing point.

Abstract: An implant structure includes a contracting mechanism, including a rotatable structure for contracting the implant structure, and a locking mechanism. A rotation tool is configured to engage and rotate the rotatable structure. A longitudinal guide member is removably coupled to the contracting mechanism, configured to guide the rotation tool to the rotatable structure, and includes a distal force applicator. The rotation tool is axially moveable with respect to the guide member. The contracting mechanism is arranged such that the locking mechanism is (a) unlocked when the guide member is coupled to the contracting mechanism in a first state, thereby allowing the rotatable structure to rotate, and (b) locked when (i) the guide member is coupled to the contracting mechanism in a second state, thereby restricting the rotation of the rotatable structure, and (ii) the guide member is not coupled to the contracting mechanism, thereby restricting the rotation of the rotatable structure.

Abstract: A wall (39) of a catheter (38) (a) includes a braided portion (41) having an outer surface (45), an inner surface (47), and a braided interior (53) between the outer and inner surfaces (45, 47), and (b) is shaped to define first and second longitudinally-running channels (27a, 27b) therethrough. A distal portion of the catheter (38) is shaped to define first and second lateral openings (26a, 26b). An angle between (a) a first line (76) running between the first and second lateral openings (26a, 26b), and (b) a second line (78) that is parallel to a central longitudinal axis of the catheter (38) when the catheter (38) is straight, is between 30 and 150 degrees.