Edwards Lifesciences Corporation

Bao Khuu

Eric Robert Dixon

Asher L Metchik

Matthew T Winston

David Mark Taylor

Sergio Delgado

Alexander J Siegel

Mark Chau

Lauren R Freschauf

Emil Karapetian

Alexander H Cooper

Christopher J Olson

Cristobal R Hernandez

Stanton J Rowe

Yoon Hee Kwon

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.

Multi-direction steerable handles for steering catheters

In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion. The prosthetic device can be movable between multiple configurations. The spacer body can be configured to extend radially outwardly as the spacer body extends away from the distal end toward the proximal end. A delivery apparatus can have a first shaft and a second shaft, wherein movement of the first shaft relative to the second shaft moves the anchor portion relative to the spacer body.

Heart valve sealing devices and delivery devices therefor

Disclosed herein are catheter control handles that include various mechanisms for controlling the circumferential angle and radial magnitude of flexion of an attached catheter. Control handles can comprise a housing. Control wires extend from a distal end of the housing and into a steerable transluminal device. A flex control member is operable to control tension on the pull wires to adjust a magnitude of radial flexion of the steerable transluminal device. A position control member is operable to control tension on the pull wires to adjust a circumferential angle in which the radial flexion of the steerable transluminal device is directed.

Multi-direction steerable handles

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.

In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion. The prosthetic device can be movable between multiple configurations. The spacer body can be made from braided, self-expandable metallic thread. A delivery apparatus can have a first shaft and a second shaft, wherein movement of the first shaft relative to the second shaft moves the anchor portion relative to the spacer body.

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.

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.

Steerable catheters include cam and follower mechanisms that provide independent control of catheter flex magnitude and catheter flex direction to provide improved steerability of an attached catheter. In certain embodiments, the steerable catheter assemblies include two or more pull wires that flex the catheter, and a control handle coupled to the catheter having a direction control and a magnitude control, both of which are operably coupled to the two or more pull wires by the cam and follower mechanism. In embodiments disclosed herein, the cam and follower system can be modified to achieve particular catheter control.

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.

Cam controlled multi-direction steerable handles

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.

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.

In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion, wherein the prosthetic device is movable between a compressed configuration, in which the spacer body portion is radially compressed and is axially spaced relative to the anchor portion, and an expanded configuration, in which the spacer body portion expands radially outwardly relative to the compressed configuration and overlaps at least a portion of the anchor portion.

In a representative embodiment, an implantable prosthetic heart valve device comprises an elongated body having first and second end portions, the body being configured to be implanted around a native leaflet of a heart valve such that the first end portion is on an atrial side of the leaflet and the second end portion is on a ventricular side of the leaflet and such that the body can coapt with and move away from an opposing native leaflet during operation of the heart valve. The device can further comprises a fastener configured to be mounted on a suture that extends from one of the first or second end portions, through the native leaflet and through the other of the first or second end portions such that the body is secured to the native leaflet.

Growing community of inventors

Irvine, CA, United States of America

Bao Khuu