Abstract: An implantable prosthetic device such as might be used to treat poor function of a diseased heart valve in a medical patient includes a body portion and an anchor portion including a plurality of paddles. Clasps attached to the paddles include fixed arms and moveable arms operable to secure the device to the patient's native valve leaflets.

Abstract: Disclosed herein are steerable catheter assemblies that utilize various mechanisms to accomplish independent control of catheter flex magnitude and catheter flex direction to provide improved steerability of an attached catheter. Some embodiments include a catheter with two or more pull wires that flex the catheter and a control handle coupled to the catheter. The control handle can include a direction control coupled to the two or more pull wires such that adjustment of the direction control adjusts a direction of catheter flex by the two or more pull wires, and the control handle can include a magnitude control coupled to the two or more pull wires such that adjustment of the magnitude control adjusts the magnitude of catheter flex.

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: Disclosed herein are steerable-catheter control handles and catheter assemblies that include pull wires and direction and magnitude controls on the handle operable such that adjustment of the direction and magnitude controls adjusts a direction and degree of catheter flex, thereby to steer the catheter as an operator directs.

Abstract: An implantable prosthetic device includes a flexible hollow tube extending from a proximal end to a distal end. A first flexible portion extends from the proximal end to a middle portion. A second flexible portion extends from the middle portion to the distal end. A first pull wire attaches to the middle portion such that applying tension to the first pull wire causes the first flexible portion to bend in a first bend direction. A second pull wire attaches to the distal end such that applying tension to the second pull wire causes the second flexible portion to bend in a second bend direction. The first bend direction is offset from the second bend direction by about 160 to about 200 degrees.

Abstract: An exemplary valve repair device is released from tissue of a valve of a patient by applying tension to a movable arm of a clasp in a retraction direction. A fixed arm of the clasp is attached to an inner paddle portion of a paddle of the valve repair device. The inner paddle portion is connected to an outer paddle portion of the paddle of the valve repair device. Pulling the moveable arm of the clasp flexes the inner paddle portion to allow the moveable arm to move in the retraction direction and thereby release the clasp from the valve tissue.

Abstract: An exemplary 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 and that allows the native leaflets to close around the coaption element during ventricular systole to block blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The coaption element can be connected to leaflets of the native valve by the anchor.

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: 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: Disclosed herein are steerable catheter assemblies and methods of steering catheters that utilize driver and follower mechanisms to accomplish independent control of catheter flex magnitude and catheter flex direction. Some embodiments include a catheter with a first pull wire and a second pull wire that flex the catheter, a control handle coupled to the catheter, a first follower connected to the first pull wire, a second follower connected to the second pull wire, and a driver disposed in the control handle and coupled to the first and second followers. The rotation of the driver coupled to the control handle moves the first and second followers in opposite directions, and axial movement of the driver moves the first and second followers in the same direction.

Abstract: Catheterization methods and apparatuses allow sensing of pressures inside the heart and for removing air from catheters. A delivery system can use the same components that are used to deliver a valve repair or replacement device to measure the pressure in the atrium or other heart chamber. A pressure sensor can be included in one of the catheters of the delivery system or pressure can be sensed through the same port that is used to flush a catheter. The delivery system can be inserted into the heart, delivering the valve repair or replacement device to the native valve, such as the mitral valve, the tricuspid valve, the aortic valve, or the pulmonary valve.

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. The clasps each have a fixed arm and a plurality of moveable arms each having a barbed portion. A plurality of hinge portions connect the moveable arms to the fixed arm.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element having four layers; and a pair of paddles 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: A valve repair delivery handle includes a housing, an actuation control mechanism, and a clasp control mechanism. The actuation control mechanism includes a knob and an actuation tube. The knob is rotatably coupled to the housing. The actuation tube is coupled to the knob such that rotation of the knob in a first direction moves the actuation tube distally relative to the housing and rotation of the knob in a second direction moves the actuation tube proximally relative to the housing. The clasp control mechanism is coupled to the housing.

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. The clasps have a fixed arm attached to the paddle and a moveable arm. The moveable arm has a barbed portion, a first eyelet, and a second eyelet. The hinge portion connects the fixed arm to the moveable arm. A first intermediate suture loop is attached to the first eyelet and a second intermediate suture loop is attached to the second eyelet. At least one actuation suture is attached to the first and second intermediate suture loops.

Abstract: A valve repair system for repairing a native valve of a patient includes a catheter and a valve repair device. The valve repair device is disposed in the catheter. The valve repair device comprises a compressible spacer and a pair of paddles. The pair of paddles are moveable between an open position and a closed position. The valve repair device can transition to a compressed configuration with the compressible spacer between the pair of paddles in the closed position.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repairing the native valve of a patient during a non-open-heart procedure. The system includes a surgical delivery instrument, a valve repair device, and a gripper control mechanism. The surgical delivery instrument has at least one lumen. The valve repair device is configured to be delivered through the lumen of the surgical delivery instrument and to be attached to a native valve of a patient. The valve repair device includes a pair of paddles, and at least four gripping members. The paddles are movable between an open position and a closed position, and the paddles and the at least four gripping members are configured to attach to the native valve of a patient. The gripper control mechanism is configured to independently move each of the at least four gripping members.

Abstract: Disclosed herein are steerable catheter assemblies and methods of steering catheters. Some embodiments include a catheter with first and second oppositely disposed pull wires and third and fourth oppositely disposed pull wires that flex the catheter, a control handle coupled to the catheter, a first follower connected to the first pull wire, a second follower connected to the second pull wire, a first driver coupled to the control handle and coupled to the first and second followers, a third follower connected to the third pull wire, a fourth follower connected to the fourth pull wire, and a second driver coupled to the control handle and coupled to the third and fourth followers. Rotation of the first driver moves the first and second followers in opposite directions. Rotation of the second driver moves the third and fourth followers in opposite directions.

Abstract: A valve repair devices and systems for repairing a native valve of a patient include a spacer, a pair of paddles, and a pair of moveable clasp arms. The pair of moveable clasp arms are disposed between the pair of paddles and the spacer. The moveable clasp arms are configured to attach to leaflets of a heart valve. The spacer, the pair of paddles, and the moveable clasp arms are configured such that, when attached to the leaflets, the moveable clasp arms are located between the spacer and first portions of the leaflet, while second portions of the leaflet engage the spacer.

Abstract: A valve repair device for repairing a native valve of a patient includes a spacer element, a pair of paddles, and a pair of gripping members. The pair of paddles is coupled to the spacer element. The pair of gripping members is disposed between the pair of paddles. The paddles and the gripping members are configured to attach to leaflets of a heart valve. The spacer element extends past side edges of the gripping members, extends past side edges of the paddles, or extends past the side edges of both the gripping members and the paddles.