Abstract: A valve repair device for repairing a native valve of a patient 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. Each paddle comprises a metal loop that is moveable from a compressed condition where each metal loop has a first width to an expanded condition where each loop has a second width that is greater than the first width. The pair of gripping members are configured to attach to the native valve of the patient.

Abstract: A delivery apparatus includes a steerable shaft having a pull-wire conduit. A pull wire extends through the pull-wire conduit. The steerable shaft includes one or more layers. A compression-resistance portion is incorporated into at least one of the one or more layers. A cross-section of the compression-resistance portion has an arcuate shape that extends along a portion of a cross-section of the steerable shaft. The compression-resistance portion has a hardness that is greater than a hardness of the one or more layers that the compression-resistance portion is incorporated into.

Abstract: In a particular embodiment, the present disclosure provides a prosthetic valve delivery assembly that includes a storage tube and a nose cone cap. A prosthetic valve having a frame is at least partially disposed within the storage tube. A nose cone is disposed about an elongated shaft. The nose cone cap and the storage tube have mating first and second locking member that can be coupled to selectively secure the nose cone cap to the storage tube.

Abstract: Certain embodiments of the present disclosure provide a prosthetic valve (e.g., prosthetic heart valve) and a valve delivery apparatus for delivery of the prosthetic valve to a native valve site via the human vasculature. The prosthetic valve comprises a frame or stent that comprises multiple cells arranged in unique ways. The prosthetic valve also comprises a leaflet assembly coupled to the frame and having a plurality of leaflets, wherein the leaflets are configured to allow blood to flow through the prosthetic heart valve in one direction from an inflow end portion to an outflow end portion of the frame or stent.

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 surgical a valve repair device for repairing a native valve of a patient including a pair of paddles, and a pair of gripping members. The paddles are movable between an open position and a closed position, in which the paddles are moved to the open position by moving a pivot point of each paddle in an outward direction and pivoting each of the paddles about the pivot point of the paddle. The paddles and the gripping members are configured to attach to the native valve of the patient when the paddles are in the closed position.

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: In a particular embodiment, the present disclosure provides a prosthetic valve delivery assembly that includes a storage tube. A prosthetic valve having a frame is at least partially disposed within the storage tube. A nose cone is disposed about an elongated shaft. A stylet having at least a first bent portion extends through a lumen of the nose cone. The at least a first bent portion is disposed within the lumen of the nose cone and restricts axial movement of the elongated shaft relative to the prosthetic valve.

Abstract: A method and system for implanting and repositioning an implantable device for a native valve of a patient's heart includes a delivery catheter, a collar, a coupler, and an actuation element. The actuation element extends through the delivery catheter and attaches to the device to open the device. The collar is connected to the device and the coupler is connected to the delivery catheter. The collar and coupler are tied together via one or more coupling tethers which can be used to reengage the device after an initial deployment.

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 surgical delivery instrument and a valve repair device. 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 a pair of gripping members. The paddles are movable between an open position and a closed position, and the paddles are configured to flex upon being attached to the native valve of a patient. The paddles and the gripping members are configured to attach to the native valve of the patient.

Abstract: In a particular embodiment, the present disclosure provides a delivery apparatus for delivering a medical device. The delivery apparatus includes an elongated component with an engagement portion and a disengagement portion. Rotating the elongated component in a first rotational direction moves the travelling component along the engagement portion in a first axial direction. When the travelling component is located within the disengagement portion, continued rotation of the elongated component in the first rotational direction does not cause further movement of the travelling component in the first axial direction. A biasing member is located proximate the disengagement portion and urges the travelling component to reengage the engagement portion. The delivery apparatus can reduce or prevent damage to the delivery apparatus, or a patient with whom the delivery apparatus is used, by reducing or eliminating torque transfer from the travelling component to an end of the elongated component.

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: 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 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: A loader and method for loading a transcatheter heart valve into a delivery sheath or catheter is described that is also configured to facilitate retrieval of the heart valve back through the delivery sheath while protecting the delivery sheath from damage. Another loader provides for easier crimping and loading of a THV into a delivery sheath or catheter from a storage jar or container. A method for crimping a THV facilitates easier end user preparation of the valve for implantation and reduces the likelihood of tissue deformation in the valve during storage. These devices and methods for deploying THVs simplify the valve replacement procedure.

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: A retrieval device for retrieving a previously implanted device from a native valve of a patient's heart includes one or more retrieval components. The retrieval components include one or more of a device securing member, a device actuation member, and a clasp capturing member. The securing member is configured to attach the retrieval device to the previously implanted device. The actuation member engages the previously implanted device to move the previously implanted device from a closed configuration to an open configuration. The clasp capturing member is configured to attach to a clasp of the previously implanted device.

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 spacer member configured to be disposed between leaflets of a native heart valve that is located between a first chamber and a second chamber of the heart. The prosthetic device further includes a plurality of anchor members coupled to the spacer member and configured to capture the leaflets between respective anchor members and the spacer member such that the prosthetic device is retained between the leaflets. The spacer member is configured to provide a flow path through the prosthetic device between the first chamber and the second chamber when the leaflets are captured between the anchor members and the spacer member such that blood can flow regurgitatively from the second chamber to the first chamber through the spacer member.

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.