Abstract: A steerable catheter control handle and method are provided for bi-directional control of a steerable catheter, the catheter including at least two control wires, a distal end of each of the control wires being coupled to the catheter at a distal region thereof. The control system comprises a housing. A wire actuation mechanism is disposed within the housing and is operably coupled to at least two control wires for enabling actuation of the at least two control wires. The steerable catheter control handle additionally comprises a proximal control knob that is operably coupled to the wire actuation mechanism to enable actuation of the at least two control wires for causing a distal end deflection of the steerable catheter.

Abstract: Embodiments of a steerable catheter control system and methods are disclosed. The steerable catheter control system comprises a housing which defines an inner housing and a slide assembly which linearly translates within the inner housing. At least two control wires are positioned through the slide assembly wherein one of the at least two controls wires are indirectly coupled to the slide assembly via the direction reversing element. The steerable catheter control system further comprises a slack limiting element, coupled to at least one of the at least two control wires. The slack limiting element allows for frictional engagement of the control wire to limit slack. The control system includes a control knob for linearly translating the slide assembly, enabling the slide assembly to manipulate the control wires which causes a change in deflection of the steerable catheter.

Abstract: An apparatus is disclosed for an optimized transseptal procedure that reduces the number of devices that are used in order to minimize procedural time, complexity and cost. The apparatus comprises a hybrid dilator that comprises the combined functionality of a transseptal sheath and dilator assembly. The hybrid dilator comprises: a dilator shaft defining a lumen for receiving a crossing device therethrough, a distal tip having an outer diameter which tapers down to an outer diameter of the crossing device for providing a smooth transition and a hub coupled with a side arm coupled to the dilator shaft.

Abstract: An apparatus and method are disclosed for providing feedback for a steerable medical device assembly for deflecting a device, the assembly comprising a control handle comprising an actuation mechanism. The assembly additionally comprises a device coupled to the control handle and operable to be deflected upon actuation of the actuation mechanism, and a feedback mechanism for providing an indication of the deflection of the device, wherein the feedback mechanism is associated with the actuation mechanism for deflecting the device.

Abstract: An apparatus and method are disclosed for providing feedback for a steerable medical device assembly for deflecting a device, the assembly comprising a control handle comprising an actuation mechanism. The assembly additionally comprises a device coupled to the control handle and operable to be deflected upon actuation of the actuation mechanism, and a feedback mechanism for providing an indication of the deflection of the device, wherein the feedback mechanism is associated with the actuation mechanism for deflecting the device.

Abstract: A method and apparatus are disclosed for a reinforced steerable sheath assembly that is usable with an actuator comprising a shaft section defining a sheath that is operable to be deflected, and one or more pull wires that are coupled to the sheath via a coupling at a point of contact between the pull wires and the sheath. The pull wires being operable to be coupled to the actuator for actuating the pull wires. The reinforced steerable sheath assembly further comprises a means for preventing displacement of the coupling, wherein the means for preventing displacement to minimize failure at the coupling at the point of contact between the pull wires and the sheath upon actuation of the pull wires upon actuation of the actuator to deflect the sheath.

Abstract: A method and apparatus are disclosed for a reinforced steerable sheath assembly that is usable with an actuator comprising a shaft section defining a sheath that is operable to be deflected, and one or more pull wires that are coupled to the sheath via a coupling at a point of contact between the pull wires and the sheath. The pull wires being operable to be coupled to the actuator for actuating the pull wires. The reinforced steerable sheath assembly further comprises a means for preventing displacement of the coupling, wherein the means for preventing displacement to minimize failure at the coupling at the point of contact between the pull wires and the sheath upon actuation of the pull wires upon actuation of the actuator to deflect the sheath.

Abstract: Embodiments of a steerable catheter control system and methods are disclosed. The steerable catheter control system comprises a housing which defines an inner housing and a slide assembly which linearly translates within the inner housing. At least two control wires are positioned through the slide assembly wherein one of the at least two controls wires are indirectly coupled to the slide assembly via the direction reversing element. The steerable catheter control system further comprises a slack limiting element, coupled to at least one of the at least two control wires. The slack limiting element allows for frictional engagement of the control wire to limit slack. The control system includes a control knob for linearly translating the slide assembly, enabling the slide assembly to manipulate the control wires which causes a change in deflection of the steerable catheter.

Abstract: A steerable catheter control handle and method are provided for bi-directional control of a steerable catheter, the catheter including at least two control wires, a distal end of each of the control wires being coupled to the catheter at a distal region thereof. The control system comprises a housing. A wire actuation mechanism is disposed within the housing and is operably coupled to at least two control wires for enabling actuation of the at least two control wires. The steerable catheter control handle additionally comprises a proximal control knob that is operably coupled to the wire actuation mechanism to enable actuation of the at least two control wires. The control knob is positioned proximal to the wire actuation mechanism to enhance ease of use of the steerable catheter control handle. The rotation of the proximal knob causes movement of the wire actuation mechanism within the housing for tensioning one of the at least two control wires for causing a distal end deflection of the steerable catheter.

Abstract: A method and apparatus are disclosed for a modified tip for a sheath assembly that provides enhanced radiopacity while maintaining the distal tip profile to maintain adequate tip stiffness and tip transition force. The disclosed method and apparatus provide a distal tip segment for a sheath assembly comprising a region of increased wall thickness along a portion or section of the distal tip segment, providing increased cross-sectional area there-along to provide enhanced radiopacity, and a distal most section of the distal tip segment having a reduced or minimal profile to provide an atraumatic tip while maintaining sufficient stiffness for crossability. The distal tip segment is operable to be coupled to a proximal shaft portion of the sheath assembly, to provide enhanced radiopacity while maintaining the distal tip profile to maintain adequate tip stiffness.

Abstract: An apparatus and method are disclosed for providing feedback for a steerable medical device assembly for deflecting a device, the assembly comprising a control handle comprising an actuation mechanism. The assembly additionally comprises a device coupled to the control handle and operable to be deflected upon actuation of the actuation mechanism, and a feedback mechanism for providing an indication of the deflection of the device, wherein the feedback mechanism is associated with the actuation mechanism for deflecting the device.

Abstract: A steerable catheter control handle and method are provided for bi-directional control of a steerable catheter, the catheter including at least two control wires, a distal end of each of the control wires being coupled to the catheter at a distal region thereof. The control system comprises a housing. A wire actuation mechanism is disposed within the housing and is operably coupled to at least two control wires for enabling actuation of the at least two control wires. The steerable catheter control handle additionally comprises a proximal control knob that is operably coupled to the wire actuation mechanism to enable actuation of the at least two control wires. The control knob is positioned proximal to the wire actuation mechanism to enhance ease of use of the steerable catheter control handle. The rotation of the proximal knob causes movement of the wire actuation mechanism within the housing for tensioning one of the at least two control wires for causing a distal end deflection of the steerable catheter.