Advanced Cardiovascular Systems, Inc.

Boston Scientific Scimed, Inc.

Cryocor, Inc.

Joseph A O'Donnell

Albert A Quinones

David J Lentz

Richard J Koerner

Alvin B Salinas

Steven T Onishi

Andrew J Zoolakis

James M Jacobs

Kevin Daley Simmons

Ronald L Lawrence

Kenneth Kay Armstrong

Damian Muldoon

Steven D Royce

Douglas R Hamper

An introducer sheath assembly comprises a tubular sheath member having a deflectable distal end portion and a sheath member lumen, a handle assembly including a steering mechanism for deflecting the distal end portion of the sheath member, and a hemostasis valve assembly. The hemostasis valve assembly includes a side port member configured to be connected to a fluid source for introducing fluid into the sheath member lumen. The side port member is axially rotatable relative to the handle assembly and the sheath member such that the side port member can remain rotationally fixed relative to the fluid source as the handle assembly and the sheath member are rotated relative to the fluid source. The side port member may also be made transparent to allow for easy visualization of air bubbles, and is also configured to allow for evacuation of any visualized air bubbles.

Handle having hub with rotating infusion sideport

Various embodiments concern an introducer sheath assembly comprising a tubular sheath member having a deflectable distal end portion and a sheath member lumen, and a handle assembly including a steering mechanism for deflecting the distal end portion of the sheath member. The distal end portion of the sheath member can deflect in different directions along a plane by selective tension in one of two pull wires. The selective tension can be caused by selective proximal or distal axial translation of a shuttle assembly relative to the tubular sheath member. The selective proximal or distal axial translation can be controlled by selective clockwise or counterclockwise rotation of a control knob.

Steerable sheath handle pulley mechanism

A bi-directional system for actively deflecting the distal tip of a catheter includes a reconfigurable tube that is positioned proximal to the catheter's distal tip. The tube is formed with slits that are arranged to allow the tube to be transformed from a relaxed, cylindrical configuration to a plurality of deflected configurations. First and second pull wires are provided, with each wire having a respective distal end that is attached to the distal end of the tube. Each wire extends to a catheter handle where it is attached to a respective reel. The reels can be rotated, back and forth, to selectively deflect or relax the tube. To ensure a smooth recovery after a relatively large deflection, a mechanism is disclosed for delaying an application of tension on one of the pull wires until at least a portion of any tension on the other pull wire is released.

System for bi-directionally controlling the cryo-tip of a cryoablation catheter

An active system for deflecting a distal portion of a catheter into a hoop configuration includes an elongated catheter body having a proximal portion and a distal portion that is formed with a lumen. A thin-walled tube, which is typically made of a metallic material, is positioned in the lumen. The tube includes a cylindrical wall and includes a plurality of lateral slits that are typically formed in the tube wall and arranged such that the tube can be transformed between a relaxed, cylindrical configuration and a deflected configuration wherein the tube is substantially hoop shaped. One end of a deflection wire is attached to the tube and the other wire end is attached to a reel that is rotationally mounted onto a catheter handle housing. In use, the reel is rotated to axially retract the wire and transform the tube into a hoop configuration.

Active system for deflecting a distal portion of a catheter into a hoop configuration

An automated engagement system for coupling the plunger of a syringe to a drive arm is provided. A pressure integrity test of the syringe assembly is automatically conducted after engagement. After a position sensor communicates a signal indicating the presence of a properly installed syringe assembly to a processor, a display prompts the operator to vent and then close a stopcock in the fluid line. The processor then controls the drive arm of the system to move into engagement with the plunger of the syringe assembly, and to move the plunger forward into the syringe barrel. The drive arm stops when a pressure sensor produces a signal indicating a positive pressure in the fluid line. The processor then controls the drive arm to move the plunger in a reverse direction until a negative pressure is detected. After this confirmation of pressure integrity in the syringe assembly, the processor controls the drive to move forward until a non-negative pressure is detected by the pressure sensor.

Automatic engagement and pressure checking system for an inflation control system

The time duration of the inflation and deflation cycles for a syringe assembly for an inflation system are measured and displayed. An inflation cycle is initiated when a increase-pressure switch is depressed. A timer will begin timing the inflation cycle when the increase-pressure switch is released and a predetermined initial pressure is detected in a tube of the syringe assembly. A deflation cycle is initiated when a decrease-pressure switch is depressed. The timer will stop measuring the inflation cycle and then begin timing the deflation cycle when the decrease-pressure switch is released and a predetermined neutral pressure is detected in a tube of the syringe assembly. Rapid deflation can be achieved by depressing a rapid-decrease-pressure switch. Upon actuation of the rapid-decrease-pressure switch, the timer immediately stops measuring the inflation cycle and begins timing the deflation cycle.

Inflation control system with elapsed time measurement

A motor controller for providing a constant rate of change of pressure during inflation and deflation of an expandable member of a catheter for use in a body lumen by an automated inflation system is disclosed. The system conforms the rate of change of pressure to a set point value by means of a feedback loop controller, and makes possible consistent inflations and deflations using an automated system regardless of variations in catheter volume and compliance characteristics. Safety features such as maximum pressure and balloon rupture alarms are also disclosed.

Motor control system for an automatic catheter inflation system

A programmable manifold system for controlling pressure and fluid delivery within and through a catheter for use in a body lumen is disclosed. By means of a feedback loop controller, the system delivers known volumes of media through the catheter and into the body lumen and the system conforms the rate of change of pressure within the catheter to a desired value and makes possible consistent expansions and deflations using an automated or semi-automated system regardless of variations in catheter volume and compliance characteristics.

Programmable manifold system for automatic fluid delivery

Syringe and sensor assembly

Inflation control system

An automated inflation/deflation system for use in connection with a dilatation balloon catheter in vascular procedures that greatly facilitates the operator's control of the inflation or deflation of the balloon and control of maneuvering the proximal end of the catheter for proper positioning of the balloon inside the patient's vasculature. By use of a pressure transducer and a display unit, the operator can monitor information relating to inflation pressure and inflation time. In addition, the system provides for safety features for effectuating a rapid reduction in balloon pressure.

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Escondido, CA, United States of America

Joseph A O'Donnell