Abstract: A coaptation-assist device (20, 120A, 120B, 120C, 320A, 320B, 420, 720) is provided for treating a native atrioventricular valve, including a loop-shaped ventricular anchor (30, 130, 330, 430, 730) which includes an anchor-loop wire loop (50, 150, 350, 450, 750), which defines at least a portion of a border of the loop-shaped ventricular anchor, and is configured to be positioned in a ventricle, extending between a ventricular apical area and a subannular surface of a target native leaflet, and to remain anchored in position against surrounding anatomy, including the subannular surface, a ventricular wall, and the ventricular apical area. A neo-leaflet (32, 132A, 132B, 132C, 332A, 332B, 332A, 332B, 432, 732) is supported by the loop-shaped ventricular anchor and is configured to at least partially replace function of the target native leaflet by providing a surface of coaptation (34, 434, 734) for one or more opposing native leaflets that oppose the target native leaflet. Other embodiments are also described.

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: 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: Disclosed are devices, systems, and methods for providing access to a patient. The patient access device comprises a proximal end, a distal end and a lumen therethrough. The patient access device further comprises a hollow shaft, an input port and a liquid supply port. At least a portion of the lumen passes through the shaft. The input port is coupled to the lumen, and the lumen and the input port are constructed and arranged to receive an elongate probe. The liquid supply port is in fluid communication with the lumen. The patient access is constructed and arranged to reduce gas from exiting the distal end while a portion of the elongate probe is positioned in the patient access device.

Abstract: Disclosed are devices, systems, and methods for providing access to a patient. The patient access device comprises a proximal end, a distal end and a lumen therethrough. The patient access device further comprises a hollow shaft, an input port and a liquid supply port. At least a portion of the lumen passes through the shaft. The input port is coupled to the lumen, and the lumen and the input port are constructed and arranged to receive an elongate probe. The liquid supply port is in fluid communication with the lumen. The patient access is constructed and arranged to reduce gas from exiting the distal end while a portion of the elongate probe is positioned in the patient access device.

Abstract: Atrial appendage occlusion devices and cardiac monitoring positioned within the left atrial appendage and/or left atrium. In some embodiments the devices include an anchoring portion adapted to anchor the device in place adjacent the left atrial appendage, the anchoring portion comprising distal deformable anchoring portion adapted to be deployed in the left atrial appendage and a proximal deformable anchoring portion being adapted to be deployed in the left atrium, a barrier element secured to the anchoring portion and adapted to cover the left atrial appendage when implanted, and adapted to prevent blood clots from passing through the barrier element, and a cardiac monitoring element secured to at least one of the anchoring portions, the monitoring element including one or more sensors within in the left atrial appendage and/or left atrium and adapted to monitor left atrial cardiac data.

Abstract: Disclosed are devices, systems, and methods for providing access to a patient. The patient access device comprises a proximal end, a distal end and a lumen therethrough. The patient access device further comprises a hollow shaft, an input port and a liquid supply port. At least a portion of the lumen passes through the shaft. The input port is coupled to the lumen, and the lumen and the input port are constructed and arranged to receive an elongate probe. The liquid supply port is in fluid communication with the lumen. The patient access is constructed and arranged to reduce gas from exiting the distal end while a portion of the elongate probe is positioned in the patient access device.

Abstract: A method is provided including making an opening (300) through an atrial septum (302) at a septal site (304) at least 5 mm from a fossa ovalis (330). A first tissue anchor (204) is endovascularly advanced to a left-atrial site (306) on an annulus of a mitral valve (310) or a wall of a left atrium (308) above the annulus. The first tissue anchor (204) is implanted at the left-atrial site (306). A second tissue anchor (24) is endovascularly advanced to a right-atrial site (320) on an annulus of a tricuspid valve (207) or a wall of a right atrium (200) above the annulus. The second tissue (24) anchor is implanted at the right-atrial site (320). The left-atrial site (306) and the right-atrial site (320) are approximated by tensioning a tether (22) that passes through the opening (300) of the atrial septum (302) and connects the first and the second tissue anchors (204, 24). Other embodiments are also described.

Abstract: A method is provided including making an opening (300) through an atrial septum (302) at a septal site (304) at least 5 mm from a fossa ovalis (330). A first tissue anchor (204) is endovascularly advanced to a left-atrial site (306) on an annulus of a mitral valve (310) or a wall of a left atrium (308) above the annulus. The first tissue anchor (204) is implanted at the left-atrial site (306). A second tissue anchor (24) is endovascularly advanced to a right-atrial site (320) on an annulus of a tricuspid valve (207) or a wall of a right atrium (200) above the annulus. The second tissue (24) anchor is implanted at the right-atrial site (320). The left-atrial site (306) and the right-atrial site (320) are approximated by tensioning a tether (22) that passes through the opening (300) of the atrial septum (302) and connects the first and the second tissue anchors (204, 24). Other embodiments are also described.

Abstract: Disclosed are devices, systems, and methods for providing access to a patient. The patient access device comprises a proximal end, a distal end and a lumen therethrough. The patient access device further comprises a hollow shaft, an input port and a liquid supply port. At least a portion of the lumen passes through the shaft. The input port is coupled to the lumen, and the lumen and the input port are constructed and arranged to receive an elongate probe. The liquid supply port is in fluid communication with the lumen. The patient access is constructed and arranged to reduce gas from exiting the distal end while a portion of the elongate probe is positioned in the patient access device.

Abstract: A medical system is provided, including a catheter body having a proximal portion and a distal portion; a shaft slidably disposed within a portion of the catheter body, the shaft defining a distal tip; a fluid injection tube coupled to the distal portion of the catheter body and the distal tip of the shaft, the fluid injection tube being transitionable from a first geometric configuration to a second geometric configuration; a membrane coupled to the shaft and enclosing at least a portion of the fluid injection tube therein; and a coolant source in fluid communication with the fluid injection tube. The first geometric configuration may be substantially linear, the second geometric configuration may be substantially helical, and the membrane may be tensioned across at least a portion of the fluid injection tube in the second geometric configuration.

Abstract: The present invention is directed to a method of securing suture within a patient. The method comprises advancing suture material into the patient, passing a portion of the suture material through tissue of the patient, and advancing a fastener catheter and a suture fastener along the suture material. The fastener catheter includes a catheter main body and a handle. The suture fastener has a generally cylindrical body formed of a shape memory material and a suture fastener inner lumen. The suture fastener has at least one engagement tab biased to extend at least partially into the suture fastener inner lumen to engage against and secure one or more lines of suture passing through the suture fastener.

Abstract: A tissue fastening device includes a suture clip holder and a suture cutter. A suture clip can be releasably secured to the suture clip holder, and a suture line or lines can pass through the clip and adjacent the suture cutter. A first movement of a control handle causes the suture clip to be released from the suture clip holder, and a second movement of the control handle causes the suture cutter to cut the suture line or lines. The first movement is different from the second movement. The first movement can be rotational, with the second movement being longitudinal. Alternatively, the first movement can be longitudinal, with the second movement being rotational. The device may include a main body, an inner body, and an outer body.

Abstract: A tissue fastening device includes a suture clip holder and a suture cutter. A suture clip can be releasably secured to the suture clip holder, and a suture line or lines can pass through the clip and adjacent the suture cutter. A first movement of a control handle causes the suture clip to be released from the suture clip holder, and a second movement of the control handle causes the suture cutter to cut the suture line or lines. The first movement is different from the second movement. The first movement can be rotational, with the second movement being longitudinal. Alternatively, the first movement can be longitudinal, with the second movement being rotational. The device may include a main body, an inner body, and an outer body.

Abstract: The present invention is directed to a method of securing suture within a patient. The method comprises advancing suture material into the patient, passing a portion of the suture material through tissue of the patient, and advancing a fastener catheter and a suture fastener along the suture material. The fastener catheter includes a catheter main body and a handle. The suture fastener has a generally cylindrical body formed of a shape memory material and a suture fastener inner lumen. The suture fastener has at least one engagement tab biased to extend at least partially into the suture fastener inner lumen to engage against and secure one or more lines of suture passing through the suture fastener.

Abstract: Atrial appendage occlusion devices and arrhythmia treatment.

Abstract: A tissue fastening device includes a suture clip holder and a suture cutter. A suture clip can be releasably secured to the suture clip holder, and a suture line or lines can pass through the clip and adjacent the suture cutter. A first movement of a control handle causes the suture clip to be released from the suture clip holder, and a second movement of the control handle causes the suture cutter to cut the suture line or lines. The first movement is different from the second movement. The first movement can be rotational, with the second movement being longitudinal. Alternatively, the first movement can be longitudinal, with the second movement being rotational. The device may include a main body, an inner body, and an outer body.

Abstract: The present invention is various systems for repairing tissue within the heart of a patient. The system of the present invention includes a guide catheter, a therapy catheter, and a fastener catheter. The therapy catheter and the fastener catheter are capable of traversing the internal lumen of the guide catheter. The fastener catheter is capable of introducing a suture clip to a desired position along suture line, deploying the suture clip to secure the suture and cutting excess suture. In addition, the present invention discloses various methods for repairing tissue.

Abstract: A medical system is provided, including a catheter body having a proximal portion and a distal portion; a shaft slidably disposed within a portion of the catheter body, the shaft defining a distal tip; a fluid injection tube coupled to the distal portion of the catheter body and the distal tip of the shaft, the fluid injection tube being transitionable from a first geometric configuration to a second geometric configuration; a membrane coupled to the shaft and enclosing at least a portion of the fluid injection tube therein; and a coolant source in fluid communication with the fluid injection tube. The first geometric configuration may be substantially linear, the second geometric configuration may be substantially helical, and the membrane may be tensioned across at least a portion of the fluid injection tube in the second geometric configuration.

Abstract: The present invention is directed to various systems for repairing tissue within the heart of a patient. The mitral valve repair system of the present invention comprises a guide catheter having a proximal end, a distal end, and at least one internal lumen formed therein, a therapy catheter capable of applying a suture to the tissue, and a fastener catheter capable of attaching a fastener to the suture. The therapy catheter and the fastener catheter are capable of traversing the internal lumen of the guide catheter. In addition, the present invention discloses various methods for repairing tissue within the heart of a patient.