Abstract: Disclosed herein are steerable catheter assemblies and methods of steering catheters that utilize gimbal plate and ring mechanisms to accomplish independent control of catheter flex magnitude and catheter flex direction. Some embodiments include a catheter with two or more pull wires that flex the catheter, a housing connected to the catheter, a gimbal ring pivotally connected to the housing, a gimbal plate pivotally connected to the gimbal ring to form a gimbal assembly, and an adjustment member coupled to the gimbal assembly, such that the adjustment member is movable axially and rotationally relative to the gimbal assembly. The two or more pull wires are connected to the gimbal plate, the adjustment member engages the gimbal plate such that movement of the adjustment member adjusts the position of the gimbal assembly to thereby flex the catheter with the pull wires.

Abstract: Disclosed herein are catheter control handles that include various cam-based mechanisms for controlling the circumferential angle and radial magnitude of flexion of an attached catheter. Control handles can comprise a housing defining a longitudinal axis extending in distal and proximal directions, a cam member that is movable axially relative to the housing and also movable rotationally about the longitudinal axis relative to the housing, at least one follower engaged with the cam member such that the at least one follower moves relative to the handle in response to the movement of the cam member, and pull wires that are coupled to the at least one follower and that extend distally out of the handle and into a steerable catheter. The at least one follower can comprise plural axial sliders, a gimbal mechanism, a ball and socket mechanism, or other mechanisms.

Abstract: Disclosed herein are steerable catheter assemblies and methods of steering catheters that utilize ball and socket mechanisms to accomplish independent control of catheter flex magnitude and catheter flex direction. Some embodiments include a catheter with two or more pull wires that flex the catheter, a first ball, a socket coupled to the first ball to form a ball and socket assembly, and an adjustment member coupled to the ball and socket assembly, such that the adjustment member is movable axially and rotationally relative to the ball and socket assembly. Two or more pull wires are connected to the socket, and the adjustment member engages the socket such that movement of the adjustment member adjusts the position of the socket relative to the first ball to thereby flex the catheter with the pull wires.

Abstract: A delivery system includes an elongate shaft, a handle, a first clasp control member, and a second clasp control member. The handle is connected to a proximal portion of the elongate shaft. The first and second clasp control members each extend into a distal portion of the elongate shaft, through at least a portion of the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle. The first and second clasp control members have paths that include a first parallel portion in the elongate shaft where the first clasp control member and the second clasp control member are parallel, and a diverging portion that is proximal to the first parallel portion where the first clasp control member diverges from the second clasp control member.

Abstract: An implantable prosthetic device has a coaption element and at least one anchor. The coaption element is configured to be positioned within the native heart valve orifice to help fill a space where the native valve is regurgitant and form a more effective seal. The coaption element can have a structure that is impervious to blood. The coaption element can be connected to leaflets of the native valve by the anchor.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a delivery catheter and a valve repair device. The valve repair device is disposed inside the delivery catheter. The valve repair device includes a pair of paddles and a pair of gripping members. The pair of paddles are movable between an open position and a closed position. The pair of paddles and the pair of gripping members are configured to secure the valve repair device to leaflets of the native valve. The pair of paddles are compressed inside the delivery catheter. Each paddle of the pair of paddles is configured to expand upon exiting the delivery catheter to increase the surface area of each paddle.

Abstract: An implantable prosthetic device includes a coaption portion, paddles, and clasps. The paddles are extendable from a folded closed position to an open position. A clasp is attached to each of the paddles. Each clasp has a fixed arm attached to the paddle and a moveable arm having a barbed portion. A hinge portion connects the fixed arm to the moveable arm. The device does not include catch points when the paddles are in the open position and the clasps are in a closed condition.

Abstract: Detecting rhythm for selectively controlling access via a programmable locking system includes the steps of detecting a plurality of primary taps made by a user; storing the time intervals as a primary input sequence; normalizing the primary input sequence; calculating a tolerance value; detecting a plurality of secondary taps made by a user; storing the time intervals as a secondary input sequence; normalizing the secondary input sequence; storing a plurality of difference values equal to the value of the differences between the corresponding time intervals of the normalized primary and secondary input sequences; generating a secondary input sequence range equal to the value of the range between the minimum and maximum values of the difference values; and providing access via the programmable locking system when the value of the secondary input sequence range is lower than the tolerance value of the primary input vibration sequence.

Abstract: A delivery system includes an elongate shaft, a handle, a first clasp control member, a second clasp control member, and an actuator. The handle is connected to a proximal portion of the elongate shaft. The first and second clasp control members each extend into a distal portion of the elongate shaft, through at least a portion of the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle. The actuator is coupled to the handle and has a first side portion connected to the first clasp control and a second side portion connected to the second clasp control.

Abstract: A delivery system includes an elongate shaft, a handle, a first clasp control member, a second clasp control member, and an actuator. The handle is connected to a proximal portion of the elongate shaft. The first and second clasp control members each extend into a distal portion of the elongate shaft, through at least a portion of the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle. The actuator is coupled to the handle and has a first side portion connected to the first clasp control and a second side portion connected to the second clasp control.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material; a coaption element formed from the strip of material; and a pair of paddles formed from the strip of material and connected to the coaption element. The paddles are movable between an open position and a closed position and the paddles are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material; a coaption element formed from the strip of material; a collar connected to the coaption element; and a pair of paddles formed from the strip of material and connected to the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material; a coaption element formed from the strip of material; a pair of paddles formed from the strip of material and connected to the coaption element; a cap attached to the paddles; and a pair of extension members connected to the cap and movable between an open position and a closed position. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient. Movement of the cap toward the coaption element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaption element causes the pair of paddles to move to the open position. In the closed position the extension members are biased in a closing direction.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element; a pair of paddles connected to the coaption element; a catch point formed by a portion of at least one of the coaption element and the pair of paddles when the paddles are in the open position; and a cover covering connected to the coaption element and the paddles for covering the catch point. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material having first and second edges surrounding a central portion; a coaption element formed from the strip of material; and a pair of paddles formed from the strip of material and connected to the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element formed from a strip of material; a pair of extension members; a pair of paddles formed from the strip of material and connected to the coaption element; and a cap attached to the paddles. The paddles are movable between an open position and a closed position, are disposed over the extension member, and are configured to attach to the native valve of the patient. Movement of the cap toward the coaption element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaption element causes the pair of paddles to move to the open position. The cap has a retention body for receiving attachment portions of the extension members, a retaining nut, and a retaining bolt for securing the retaining nut.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element; a pair of paddles connected to the coaption element; a first cover extending from a distal end of the device and covering at least a portion of the paddles; and a second cover extending from a proximal end of the device and covering at least a portion of the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material; a coaption element formed from the strip of material; a pair of paddles formed from the strip of material and connected to the coaption element; a cap attached to the paddles; and a pair of extension members connected to the cap and the paddles via attachment portions. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient. Movement of the cap toward the coaption element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaption element causes the pair of paddles to move to the open position. The extension members extend to end portions attached to the strip material. The end portions extend beyond the strip of material.

Abstract: A method of manufacturing a valve repair device for repairing a native valve of a patient includes: folding a strip of material formed from shape-memory alloy around a jig to form a coaption element and a pair of paddles connected to the coaption element, wherein the paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient; and heat treating the strip of material to shape-set the strip of material in the shape of the coaption element and paddles.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a collar; a coaption element attached to the collar; and a pair of paddles are connected to the coaption element. The collar has a plurality of engagement portions configured to releasably engage a delivery apparatus. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient. The paddles are circumferentially disposed between the engagement portions.