Abstract: An adjustment tool enables manipulation of a prosthetic anatomical device such as an annuloplasty ring. The tool includes a compression member which is operative for retarding rotation of the adjustment shaft to preclude inadvertent rotation thereof during use of the tool by the surgeon. A locking device is associated with the adjustment tool to enable the releasable attachment of the tool to the anatomical device during its adjustment by manipulation of the tool. The locking device is oriented into operative and inoperative positions by the engagement and disengagement of locking elements. A scale may be provided on the adjustment tool to assist a surgeon in determining the size or amount of adjustment to the size of the anatomical device during its adjustment.

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.

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: 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.

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: 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: An apparatus for deployment of a hemostatic clip comprises 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 from the shaft.

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 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: 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 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: An adjustment assembly for an adjustable prosthetic valve device includes a gearbox housing formed from two gearbox shells coupled to one another and held together by two gearbox sleeves each having an internal cavity adapted to accommodate respective lateral portions of the gearbox shells when the gearbox shells are coupled to one another. A gear assembly, including a center gear and two driven gears, is supported within the gearbox housing. Gear teeth of each of the driven gears engage gear teeth of the center gear such that rotation of the center gear causes rotation of the driven gears. At least one of the driven gears is adapted to engage a transmission mechanism that transmits the rotation thereof to another part of the adjustable prosthetic valve device to accomplish an adjustment to the size and/or shape of the adjustable prosthetic valve device.

Abstract: A device for transcatheter gathering of tissue of a heart valve leaflet may include an elongated tube extending in a longitudinal direction and a capture tool moveable in the elongated tube between a retracted position and an extended position. The elongated tube may have at least one slot extending generally in the longitudinal direction from a distal end of the elongated tube. The at least one slot may have an open end at the distal end of the elongated tube and a closed end remote therefrom. The capture tool may be operable to gather tissue of the heart valve leaflet into the at least one slot. The gathered tissue may have a pleated configuration.

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 includes a clip including first and second arms distal ends of which are biased apart and a core member including first and second portions connected to one another via a frangible link. The first portion includes a first protrusion for engaging a cut-out in the first arm. The frangible link is fractured when subjected to a load of at least a predetermined level deploying the clip. The device also includes a capsule slidably housing the core member and a proximal portion of the clip.

Abstract: An apparatus for deployment of a hemostatic clip comprises 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 from the shaft.

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 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 includes a clip including first and second arms distal ends of which are biased apart and a core member including first and second portions connected to one another via a frangible link. The first portion includes a first protrusion for engaging a cut-out in the first arm. The frangible link is fractured when subjected to a load of at least a predetermined level deploying the clip. The device also includes a capsule slidably housing the core member and a proximal portion of the clip.