Abstract: An articulation segment for a catheter includes a tube formed with a first plurality of axially aligned slits that are respectively oriented in planes perpendicular to the axis, with each slit extending azimuthally in an arc partway around the axis. The tube is also formed with a second plurality of similarly formed slits that are axially offset and diametrically opposed relative to the slits of the first plurality to allow for a bending of the catheter in a plurality of different planes. In a particular embodiment, the slits are arranged to allow the articulation segment to be reconfigured from a straight, substantially cylindrically shaped tube to a configuration in which a portion of the articulation segment is formed in the shape of a ring.

Abstract: An articulation segment for a catheter includes a tube formed with a first plurality of axially aligned slits that are respectively oriented in planes perpendicular to the axis, with each slit extending azimuthally in an arc partway around the axis. The tube is also formed with a second plurality of similarly formed slits that are axially offset and diametrically opposed relative to the slits of the first plurality to allow for a bending of the catheter in a plurality of different planes. In a particular embodiment, the slits are arranged to allow the articulation segment to be reconfigured from a straight, substantially cylindrically shaped tube to a configuration in which a portion of the articulation segment is formed in the shape of a ring.

Abstract: 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.

Abstract: A cryoablation device having a temperature control system includes an elongated catheter tube that has a central lumen and is formed with a closed distal tip. The distal end of a refrigerant supply line is positioned in the central lumen and distanced from the catheter tube's distal tip to establish an expansion chamber therebetween. A return line, which can be established between the supply line and the catheter tube, is provided to exhaust expanded refrigerant from the chamber. The temperature control system includes a valve that is positioned at a predetermined location along the return line. The valve is adjustable to vary a pressure within the return line to control the operational temperature at the distal tip of the catheter tube. Specifically, the valve can be used to reduce the pressure in the return line to thereby increase the tip temperature, and vice versa.

Abstract: An apparatus and method for automatic operation of a refrigeration system to provide refrigeration power to a catheter for tissue ablation or mapping. The primary refrigeration system can be open loop or closed loop, and a precool loop will typically be closed loop. Equipment and procedures are disclosed for bringing the system to the desired operational state, for controlling the operation by controlling refrigerant flow rate, for performing safety checks, and for achieving safe shutdown. The catheter-based system for performing a cryoablation procedure uses a precooler to lower the temperature of a fluid refrigerant to a sub-cool temperature (?40° C.) at a working pressure (400 psi). The sub-cooled fluid is then introduced into a supply line of the catheter. Upon outflow of the primary fluid from the supply line, and into a tip section of the catheter, the fluid refrigerant boils at an outflow pressure of approximately one atmosphere, at a temperature of about ?88° C.

Abstract: 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.

Abstract: A device and method for ablating tissue includes a sheath system with an occlusion structure. In certain embodiments, arrhythmias originating in pulmonary veins are treated cryogenically.

Abstract: A system for cryoablating target tissue at a treatment site includes a cryo-element that is attached to the distal end of a cryo-catheter. An annular shaped balloon is attached to a cylindrical shaped sleeve and the sleeve is slideably mounted over the cryo-catheter. The distal end of a fill tube is attached to the sleeve to place the lumen of the fill tube in fluid communication with the balloon. In use, the cryo-element is first positioned at the treatment site using the cryo-catheter. Next, the fill tube is used to advance the balloon and sleeve over the cryo-catheter until the balloon is interposed between the cryo-element and the target tissue. Saline solution is then pumped through the fill tube to expand the balloon between the cryo-element and target tissue. A refrigerant is then expanded in the cryo-element which freezes the saline solution and cryoablates the target tissue.

Abstract: A system for detecting leaks and occlusions in a cryoablation catheter requires monitoring pressure in the catheter at the end of two predetermined time intervals. The catheter includes a catheter tube, a cryo-chamber at the distal end of the catheter, and a supply line for introducing fluid refrigerant into the cryo-chamber. Also included is a pressure sensor mounted in the cryo-chamber for measuring a tip pressure. During the first time interval, fluid refrigerant is prevented from flowing through the catheter while the catheter is evacuated by a vacuum pump. The tip pressure is then measured to detect leaks. During the second time interval, fluid refrigerant is introduced into the cryo-chamber while evacuation continues, and the tip pressure is measured to detect occlusions.

Abstract: A cryoablation device having a pressure monitoring system includes an elongated catheter tube that has a central lumen and is formed with a closed distal end. The distal end of a refrigerant supply line is positioned in the central lumen and distanced from the catheter tube's distal end to establish an expansion chamber therebetween. A return line, which can be established between the supply line and the catheter tube or can include a return tube, is provided to exhaust expanded refrigerant from the chamber. First and second pressure sensors are respectively positioned in the supply line upstream from the expansion chamber and in the return line. Typically, both sensors are positioned to remain at extracorporeal locations throughout a cryoablation procedure. Measured pressures are used together with the supply and return line dimensions to analytically estimate the chamber pressure and allow the expansion of refrigerant in the chamber to be monitored.

Abstract: A device for cryoablating exposed tissue having a contoured contact surface includes a tube-shaped shaft and a flexible, thermally conductive enclosure that is attached to the distal end of the tube-shaped shaft. The enclosure is formed with a wall having an outer surface for contacting the target tissue and an inner surface which establishes and surrounds a cryochamber. A shapeable element is attached to the distal end of the shaft and extends into the cryochamber. The element can be permanently deformed into a pre-selected shape to cause a portion of the enclosure wall to conform to the contour of the target tissue. A high-pressure tube in the shaft passes a refrigerant through the shaft for expansion into the cryochamber. This expansion cools the wall of the enclosure, which in turn, extracts heat from the target tissue resulting in the cryoablation of the target tissue.

Abstract: Systems and methods for assessing the formation of an ice ball during a cryoablation procedure are disclosed. The system includes a reference electrode that is placed in contact with the patient and a cryocatheter having a cryotip. An electronic circuit is connected to both the cryotip and the reference electrode to measure the impedance therebetween which can be used to assess the formation of an ice ball during a cryoablation procedure. An exemplary measurement signal has a frequency of approximately 20 khz and an RMS voltage of approximately 0.5V. With the cryotip positioned proximate the target tissue, a reference impedance is measured. Next, the conductive tip member is placed in contact with the target tissue and cooled to form an ice ball. During cooling, impedance measurement(s) are taken and compared with the reference impedance to assess the formation of the ice ball.

Abstract: A catheter-based system for performing a cryoablation procedure uses a precooler to lower the temperature of a fluid refrigerant to a sub-cool temperature (?40° C.) at a working pressure (400 psi). The sub-cooled fluid is then introduced into a supply line of the catheter. Upon outflow of the primary fluid from the supply line, and into a tip section of the catheter, the fluid refrigerant boils at an outflow pressure of approximately one atmosphere, at a temperature of about ?88° C. In operation, the working pressure is computer controlled to obtain an appropriate outflow pressure for the coldest possible temperature in the tip section.

Abstract: A device for steering a cardiac cryoablation catheter through the vasculature of a patient includes separate first and second deflection members that connect a tip member to the distal end of a catheter tube. Importantly, the first deflection member has a first flexural modulus, and the second deflection member has a second flexural modulus that is greater than the first flexural modulus. Also included is a control wire for pulling the tip member toward the catheter tube. In response, the first and second deflection members differentially deflect, according to their respective flexural moduli, to move the tip member for steering the catheter through the vasculature.

Abstract: A method of cooling an operative surface of a cryoablation device, comprises the steps of providing a primary refrigerant under pressure and pre-cooling the primary refrigerant to a temperature below a critical temperature thereof using a non-charging refrigeration system to liquify the refrigerant in combination with the steps of expanding the pre-cooled primary refrigerant in proximity to an operative surface of the cryoablation device and removing the expanded primary refrigerant from the proximity of the operative surface.

Abstract: A system and method for transferring heat requires a supply tube connected in fluid communication with a capillary tube. A tip member is positioned to surround the distal end of the capillary tube to create a cryo-chamber. In operation, a liquid refrigerant is introduced into the supply tube at a working pressure (e.g. 450 psia). The pressure is then significantly reduced on the liquid refrigerant as it transits through the capillary tube. The refrigerant then exits the distal end of the capillary tube, still in its liquid state. Inside the cryo-chamber, at a pressure of less than about one atmosphere, the refrigerant transitions into its gaseous state. The resultant refrigeration causes heat to transfer into the cryo-chamber.

Abstract: A heat transfer segment for a cryoablation catheter includes a member, at least a portion of which is made of a thermally conductive composite material. The composite material includes a polymeric matrix material such as a polyether block amide (PEBA) and a filler material which can include metals, metal alloys, ceramics, carbon and combinations thereof. One particular composition for the composite material includes approximately twenty weight percent of filler material, with the balance being polymeric matrix material. The composite has a thermal conductivity that is significantly increased relative to the polymeric matrix material and a flexibility that is not significantly reduced relative to the polymeric matrix material. In use, the heat transfer segment is disposed within a patient's body and positioned adjacent target tissue. A refrigerant is then introduced into the heat transfer segment causing heat to flow from the target tissue, through the member and into the refrigerant.

Abstract: A catheter usable for cryogenic ablation of tissues is described. The catheter has a deflectable segment with a reduced diameter and a tip portion with a diameter greater than the reduced diameter. A resilient element allows for bending of the deflectable segment preferentially in one plane, and an actuator is used to control the bending of the deflectable segment.

Abstract: A system and method for cryoablating tissue at a target site in a patient includes a cryotip attached to the distal end of a catheter tube. The cryotip is made of a conductive polymer material that is heat set into a spiral configuration. Inside the cryotip is a configuration lumen. The cryotip assumes a straight configuration when a straightening member is positioned in the configuration lumen, and it assumes the spiral configuration when the straightening member is absent from the configuration lumen. The cryotip in the straight configuration is guided through the vasculature of a patient to the target site. At the target site, the straightening member is removed to configure the cryotip into the spiral configuration to contact the cryotip with circumferential tissue around the target site. A refrigerant fluid is then introduced into the expansion chamber of the cryotip to cool the tip to cryoablate the circumferential tissue.

Abstract: A catheter-based system for performing a cryoablation procedure uses a precooler to lower the temperature of a fluid refrigerant to a sub-cool temperature (?40° C.) at a working pressure (400 psi). The sub-cooled fluid is then introduced into a supply line of the catheter. Upon outflow of the primary fluid from the supply line, and into a tip section of the catheter, the fluid refrigerant boils at an outflow pressure of approximately one atmosphere, at a temperature of about ?88° C. In operation, the working pressure is computer controlled to obtain an appropriate outflow pressure for the coldest possible temperature in the tip section.