Abstract: An apparatus for deployment of a hemostatic clip includes a handle assembly, a shaft connected to a distal portion thereof and a clip assembly releasably coupled to a distal portion of the shaft. The clip assembly includes clip arms and a capsule cooperating with the clip arms to provide a first user feedback indicating a decision configuration of the clip assembly. In addition, the apparatus includes a control wire including a ball connector, the control wire extending from the handle assembly and coupled to the clip assembly by the ball connector to maintain the clip assembly coupled to the shaft, wherein the ball connector is detachable from the clip assembly to provide a second user feedback indicating separation of the clip assembly.

Abstract: A medical device includes a clip having first and second arms biased toward an open configuration; a control wire removably connected to the clip, the control wire configured to control movement of the clip between an open configuration and a closed configuration; a separable yoke connecting the control wire to the clip, the yoke configured to be separated by a predetermined force applied by the control wire so that, when the yoke is separated, the control wire and the yoke uncouple from the clip; an elongated sheath housing the control wire; a handle coupled to the elongated sheath; and an actuator coupled to the control wire and configured to open the clip arms, close the clip arms and uncouple the clip from the control wire.

Abstract: An introducer (10) with a steerable distal tip section (17) is disclosed. The steerable distal tip section may comprise an articulation support member comprising a laser-cut pattern of symmetrical elongated apertures in which the shape of each aperture is defined by at least three radii, a central radii being the largest and two end radii being smaller. This pattern of apertures can minimize ovaling of the cross-sectional shape of introducer shaft over the length of the deflectable section. The introducer can articulate in multiple planes. A tension pull wire can allow the introducer to resist directional bias.

Abstract: A device 10 for repairing mitral valve leaflets 2, 3 includes a jaw mechanism 15 that may be positioned adjacent a mitral valve leaflet 2, 3. The jaw mechanism 15 may move between an open position and a closed position by pivoting a first jaw relative 16 to a second jaw 18. The first jaw 16 may include a rivet 28 that may move from a stored position to an application position projecting away from the first jaw 16 when the jaw mechanism 15 is moved from the closed to the open position. Closing the jaws 16, 18 about a valve leaflet 2, 3 causes the rivet 28 to pierce the leaflet. The jaw mechanism 15 may then be rotated to wind the leaflet 2, 3 thereabout and again pierce the leaflet. The rivet 28 may then be released from the jaw mechanism 25 and the device 10 removed from the patient.

Abstract: A tissue clipping apparatus, comprises a flexible, elongate member, a proximal end of which remains external to the body accessible to a user while a distal end of the flexible member is inserted into the body to a location adjacent to target tissue to be clipped and a control wire extending through the flexible member in combination with a capsule releasably coupled to a distal end of the flexible member and a clip a proximal portion of which is received within the capsule. A joint releasably coupling the clip to the control wire, includes a yoke extending around a proximal end of the clip and a frangible link which fails when subject to a predetermined force to separate the clip from the control wire.

Abstract: An apparatus for deployment of a hemostatic clip includes a clip assembly releasably coupled to a distal portion of a shaft, wherein the clip assembly includes a capsule releasably coupled to the shaft, clip arms slidably received within the capsule and cooperating with the capsule to provide a first user feedback indicating a decision configuration of the clip assembly and a yoke slidably received within the capsule, the yoke including proximal and distal portions releasably and rotatably connected to one another via a first control wire, a distal end of the distal portion being connected to proximal ends of the clip arms. A second control wire extends from the handle assembly and is coupled to a proximal end of the second portion to move the clip assembly between open and closed configurations.

Abstract: A tissue clipping apparatus, comprises a flexible, elongate member, a proximal end of which remains external to the body accessible to a user while a distal end of the flexible member is inserted into the body to a location adjacent to target tissue to be clipped and a control wire extending through the flexible member in combination with a capsule releasably coupled to a distal end of the flexible member and a clip a proximal portion of which is received within the capsule. A joint releasably coupling the clip to the control wire, includes a yoke extending around a proximal end of the clip and a frangible link which fails when subject to a predetermined force to separate the clip from the control wire.

Abstract: An apparatus for deployment of a hemostatic clip includes a clip assembly releasably coupled to a distal portion of a shaft, wherein the clip assembly includes a capsule releasably coupled to the shaft, clip arms slidably received within the capsule and cooperating with the capsule to provide a first user feedback indicating a decision configuration of the clip assembly and a yoke slidably received within the capsule, the yoke including proximal and distal portions releasably and rotatably connected to one another via a first control wire, a distal end of the distal portion being connected to proximal ends of the clip arms. A second control wire extends from the handle assembly and is coupled to a proximal end of the second portion to move the clip assembly between open and closed configurations.

Abstract: A method of gathering tissue of a heart valve leaflet 2 may include inserting an elongated catheter assembly 12 to a position adjacent the heart valve leaflet, the catheter assembly including a capture tool 22 and a tissue support member 30. The capture tool 22 and the tissue support member 30 may each be independently moveable between a retracted position and an extended position. Partially retracting the capture tool 22 with the tissue support member 30 in the extended position gathers tissue 15 of the heart valve leaflet 2 between the capture tool and the tissue support member. A clip 55 may then be applied from the catheter assembly 12 to the gathered tissue 15 to hold the tissue substantially in a gathered configuration.

Abstract: A hemostatic clip assembly for mounting on a delivery device comprises a capsule and a clip slidably mounted within the capsule so that, when the clip is drawn proximally into the capsule, arms of the clip are drawn together to a closed position, an abutting surface of at least one of the arms contacting a corresponding surface of the capsule when the clip is drawn to a predetermined position within the capsule to provide a first user feedback indicating closure of the clip in combination with a tension member connected to the clip arms and biasing the clip arms toward an open, tissue receiving configuration and a yoke slidably received within the capsule and releasably coupled to the tension member, the yoke including a ball cavity for receiving a ball connector of a control element of the delivery device to maintain the clip assembly coupled to the delivery device, wherein the control element is frangible to detach the yoke from the delivery device and to provide a second user feedback and, wherein release

Abstract: An adjustable prosthetic anatomical holder system may include an adjustable annuloplasty ring, a ring holder, and a positioning handle. The adjustable annuloplasty ring holder facilitates placement and adjustment of the annuloplasty ring during a cardiac surgical procedure. An optional positioning handle holds the adjustable annuloplasty ring during placement and suturing of the ring. The ring holder is constructed from two members that are slidably fit together in telescopic arrangement to accommodate adjustment of the ring size.

Abstract: A hemostatic clip assembly for mounting on a delivery device comprises a capsule and a clip slidably mounted within the capsule so that, when the clip is drawn proximally into the capsule, arms of the clip are drawn together to a closed position, an abutting surface of at least one of the arms contacting a corresponding surface of the capsule when the clip is drawn to a predetermined position within the capsule to provide a first user feedback indicating closure of the clip in combination with a tension member connected to the clip arms and biasing the clip arms toward an open, tissue receiving configuration and a yoke slidably received within the capsule and releasably coupled to the tension member, the yoke including a ball cavity for receiving a ball connector of a control element of the delivery device to maintain the clip assembly coupled to the delivery device, wherein the control element is frangible to detach the yoke from the delivery device and to provide a second user feedback and, wherein release

Abstract: A tissue clipping apparatus comprises a clip including a proximal end received within a capsule. The clip includes a clip locking member biased to engage a first locking structure of the capsule to lock the clip in the capsule in a closed configuration. The apparatus also comprises a tension member releasably coupling the clip to a proximal end of the device which, during use, remains accessible to a user. The tension member is coupled to the clip by a joint designed to release when subject to a predetermined load to separate the clip from the device, release of the joint releasing the locking member to engage the first locking structure.

Abstract: A transapical introducer includes a housing near a proximal end of the introducer, a first valve in the housing, a proximal tube coupled to the housing, and a distal tube coupled to a distal end of the proximal tube.

Abstract: A delivery device for a collapsible prosthetic heart valve includes an operating handle and a catheter assembly. The operating handle may include a housing defining a movement space therein, a carriage assembly moveable in a longitudinal direction within the movement space, a deployment actuator coupled to the housing and rotatable relative to the housing, and a coupling assembly rotationally fixed to the deployment actuator. The catheter assembly may include a first shaft around which a compartment is defined and a distal sheath operatively connected to the carriage assembly. Movement of the carriage assembly in the longitudinal direction in the movement space may move the distal sheath between the closed condition and the open condition. The coupling assembly may have an engaged position in which rotation of the deployment actuator moves the carriage assembly, and a disengaged position in which rotation of the deployment actuator does not move the carriage assembly.

Abstract: A tissue clipping apparatus comprises a clip including a proximal end received within a capsule. The clip includes a clip locking member biased to engage a first locking structure of the capsule to lock the clip in the capsule in a closed configuration. The apparatus also comprises a tension member releasably coupling the clip to a proximal end of the device which, during use, remains accessible to a user. The tension member is coupled to the clip by a joint designed to release when subject to a predetermined load to separate the clip from the device, release of the joint releasing the locking member to engage the first locking structure.

Abstract: A transapical introducer (100) includes a housing (140) near a proximal end of the introducer, a first valve (160) in the housing, a proximal tube (130) coupled to the housing, and a distal tube (110) coupled to a distal end of the proximal tube.

Abstract: A delivery device for a collapsible prosthetic heart valve includes an operating handle and a catheter assembly. The operating handle may include a housing defining a movement space therein, a carriage assembly moveable in a longitudinal direction within the movement space, a deployment actuator coupled to the housing and rotatable relative to the housing, and a coupling assembly rotationally fixed to the deployment actuator. The catheter assembly may include a first shaft around which a compartment is defined and a distal sheath operatively connected to the carriage assembly. Movement of the carriage assembly in the longitudinal direction in the movement space may move the distal sheath between the closed condition and the open condition. The coupling assembly may have an engaged position in which rotation of the deployment actuator moves the carriage assembly, and a disengaged position in which rotation of the deployment actuator does not move the carriage assembly.

Abstract: A device for repair of a heart valve leaflet includes an elongated catheter assembly having a proximal end and a distal end, and a tip at the distal end of the catheter assembly. A capture mechanism having a first free end and a second free end is rotatably coupled to a distal end of the tip. A plication mechanism has an open configuration and a closed configuration, and extends between the first free end and the second free end of the capture mechanism when in the open configuration. The device may also include a clip housing at a proximal end of the tip configured to hold a clip therein.

Abstract: A device 10 for gathering tissue in a patient includes an elongated catheter 14 and a capture assembly 13 at a distal portion of the catheter. The capture assembly has a closed side 18 and a door 20 rotatable between an open condition and a closed condition. The closed side 18 of the capture assembly 13 and the door 20 in the closed condition may collectively define a tissue capturing compartment 19. Movement of the door 20 from the open condition to the closed condition adjacent the tissue may capture a portion 44 of the tissue in the tissue capturing compartment 19. A clip may then be applied from the capture assembly 13 to the captured tissue 44 to hold the tissue substantially in a gathered configuration.