Abstract: A system and method for controlling the inflation, ablation, and deflation of a balloon catheter. The system includes a balloon catheter, a console, a pressurized gas or liquid inflation source, and an umbilical system to deliver pressurized coolant to the balloon catheter. The system may include controller that monitors the amount of pressure and volume within the balloon catheter. During inflation, the pressure and/or volume of fluid within the balloon is maintained at a target amount in order to provide sufficient mechanized pressure against the desired target region. The system limits the inflation pressure such that a safe quantity of gas would be released should a leak occur. If the amount falls below a certain threshold level, gas or fluid egress is presumed and the inflation process is halted.

Abstract: A medical apparatus and system for determining contact assessment includes a catheter having an elongate body having a proximal end, a distal end opposite the proximal end, and defining an injection lumen and an exhaust lumen, an expandable membrane defining a cooling chamber disposed at a point along the elongate body, the cooling chamber in fluid communication with the injection lumen and the exhaust lumen, and a contact assessment element which may be a temperature sensor located proximate the coolant return lumen for measuring an internal temperature of the chamber. The system may include the catheter, a console having a fluid supply, an exhaust path and at least one control mechanism operationally coupled to the temperature sensor for processing a temperature signal received from the temperature sensor. The apparatus and system can also have multiple electrodes to measure and process various impedances to determine contact assessment.

Abstract: A medical apparatus and system for determining contact assessment includes a catheter having an elongate body having a proximal end, a distal end opposite the proximal end, and defining an injection lumen and an exhaust lumen, an expandable membrane defining a cooling chamber disposed at a point along the elongate body, the cooling chamber in fluid communication with the injection lumen and the exhaust lumen, and a contact assessment element which may be a temperature sensor located proximate the coolant return lumen for measuring an internal temperature of the chamber. The system may include the catheter, a console having a fluid supply, an exhaust path and at least one control mechanism operationally coupled to the temperature sensor for processing a temperature signal received from the temperature sensor. The apparatus and system can also have multiple electrodes to measure and process various impedances to determine contact assessment.

Abstract: A system and method for controlling the inflation, ablation, and deflation of a balloon catheter. The system includes a balloon catheter, a console, a pressurized gas or liquid inflation source, and an umbilical system to deliver pressurized coolant to the balloon catheter. The system may include controller that monitors the amount of pressure and volume within the balloon catheter. During inflation, the pressure and/or volume of fluid within the balloon is maintained at a target amount in order to provide sufficient mechanized pressure against the desired target region. The system limits the inflation pressure such that a safe quantity of gas would be released should a leak occur. If the amount falls below a certain threshold level, gas or fluid egress is presumed and the inflation process is halted.

Abstract: A catheter includes a first expandable membrane having a first pressurization limit and a second expandable membrane, having a second pressurization limit, wherein the second pressurization limit is greater than the first pressurization limit, the first expandable membrane defines a cooling chamber, the second expandable membrane being disposed around the first expandable membrane to define an junction therebetween. The catheter includes a coolant injection lumen in fluid communication with the at least one fluid inlet port and the cooling chamber, and a primary coolant return lumen in fluid communication with the at least one fluid outlet port and the cooling chamber. The coolant injection tube, the cooling chamber, and the primary coolant return lumen define a first fluid pathway. The catheter further includes a secondary coolant return lumen in fluid communication with the at least one fluid outlet port and the junction. The junction and the secondary coolant return lumen define a second fluid pathway.

Abstract: A method of treating a target tissue including positioning a treatment element of a medical device adjacent the target tissue; setting a first target temperature of the treatment element; operating the treatment element to reach the first target temperature; thermally treating the target tissue with the treatment element; monitoring a physiological parameter; setting a second target temperature of the treatment element based on the monitored physiological parameter; and operating the treatment element to reach the second target temperature.

Abstract: A medical system, including a catheter body, a mesh coupled to the catheter body; an expandable element enclosing the mesh, the expandable element made from a compliant natural rubber emulsion, such as Yulex® HA; and a cryogenic coolant source in fluid communication with the expandable element.

Abstract: A medical system, including a catheter body, an expandable element coupled to the catheter body; a first electrically-conductive element coupled to an interior surface of the expandable element; and a second electrically-conductive element coupled to an exterior surface of the expandable element, where the first and second electrically-conductive elements form a capacitor with the expandable element.

Abstract: A method of treating a tissue region, including deploying a plurality of sensors of a medical device into contact with the tissue region; measuring at least one of an electrical voltage, capacitance or resistance value with at least one of the plurality of sensors; generating a position indicator based at least in part on the measured value; inflating an expandable element of the medical device, and thermally affecting the tissue region with the expandable element.

Abstract: An elongated catheter device with a distal balloon assembly is adapted for endovascular insertion. Coolant injected through the device may, in different embodiments, directly cool tissue contacting the balloon, or may cool a separate internal chamber. Plural balloons may be provided, wherein a secondary outer balloon surrounds a primary inner balloon, the primary balloon being filled with coolant and acting as the cooling chamber, the secondary balloon being coupled to a vacuum return lumen to serve as a robust leak containment device and thermal insulator around the cooling chamber. One or more sensors may be disposed between the balloons or the vacuum return lumen, to detect leaks and control the flow of fluid through the device. Examples of sensors include pressure and temperature sensors, optical sensors, magnetic flow switches and flow meters.

Abstract: The present invention provides a medical device having an elongate body with both a proximal end and a distal end, wherein the elongate body defines an intake lumen and an exhaust lumen. The medical device also has a first pliable element defining a cooling chamber disposed at a point along the elongate body, with the cooling chamber being in fluid communication with the intake lumen and the exhaust lumen. A second pliable element is provided which at least partially encloses the first pliable element, thereby defining a junction between the first and second pliable element. A check valve is included which is in fluid communication with the junction between the first pliable element and second pliable element, the valve further being in fluid communication with the exhaust lumen. Additionally, the medical device may include sensors or other monitoring means in fluid communication with the junction and the cooling chamber.

Abstract: A medical device is disclosed, including a catheter body; an electrode array coupled to the catheter body, the electrode array being transitionable from a substantially linear configuration to a substantially helical configuration; and a fluid conduit coupled to the catheter body spaced apart from the electrode array, wherein the fluid conduit is transitionable from a substantially linear configuration to a substantially helical configuration. The device may include a fluid source in communication with the fluid conduit and a radiofrequency signal generator coupled to the electrode array.

Abstract: The present invention provides a medical device having an elongate body with both a proximal end and a distal end, wherein the elongate body defines an intake lumen and an exhaust lumen. The medical device also has a first pliable element defining a cooling chamber disposed at a point along the elongate body, with the cooling chamber being in fluid communication with the intake lumen and the exhaust lumen. A second pliable element is provided which at least partially encloses the first pliable element, thereby defining a junction between the first and second pliable element. Moreover, a check valve is included which is in fluid communication with the junction between the first pliable element and second pliable element, the valve further being in fluid communication with the exhaust lumen. In addition, the medical device may include sensors or other monitoring means in fluid communication with the junction and the cooling chamber.

Abstract: The present invention provides a medical device having an elongate body with both a proximal end and a distal end, wherein the elongate body defines an intake lumen and an exhaust lumen. The medical device also has a first pliable element defining a cooling chamber disposed at a point along the elongate body, with the cooling chamber being in fluid communication with the intake lumen and the exhaust lumen. A second pliable element is provided which at least partially encloses the first pliable element, thereby defining a junction between the first and second pliable element. Moreover, a check valve is included which is in fluid communication with the junction between the first pliable element and second pliable element, the valve further being in fluid communication with the exhaust lumen. In addition, the medical device may include sensors or other monitoring means in fluid communication with the junction and the cooling chamber.

Abstract: A method and system for delivering coolant to a medical device having an expandable element, a guidewire lumen movable within the medical device, and an actuator element coupled to the guidewire lumen for manipulation of longitudinal movement thereof is provided, including transferring a fluid from a console to the medical device to inflate the expandable element; manipulating the actuator element, and initiating a predetermined fluid control sequence of the console in response to the manipulation of the actuator element.

Abstract: A catheter includes a first expandable membrane having a first pressurization limit and a second expandable membrane, having a second pressurization limit, wherein the second pressurization limit is greater than the first pressurization limit, the first expandable membrane defines a cooling chamber, the second expandable membrane being disposed around the first expandable membrane to define an junction therebetween. The catheter includes a coolant injection lumen in fluid communication with the at least one fluid inlet port and the cooling chamber, and a primary coolant return lumen in fluid communication with the at least one fluid outlet port and the cooling chamber. The coolant injection tube, the cooling chamber, and the primary coolant return lumen define a first fluid pathway. The catheter further includes a secondary coolant return lumen in fluid communication with the at least one fluid outlet port and the junction. The junction and the secondary coolant return lumen define a second fluid pathway.

Abstract: A system and method for controlling the inflation, ablation, and deflation of a balloon catheter is provided. The system includes a balloon catheter, a console having a pressurized gas or liquid inflation source, and an umbilical system to deliver pressurized coolant to the balloon catheter. The system comprises a PID (Proportional Integral Derivative) controller or other pressure-sensing device that monitors the amount of pressure and volume within the balloon catheter. During inflation, the pressure and/or volume of fluid within the balloon is maintained at a target amount in order to provide sufficient mechanized pressure against the desired target region. The system limits the inflation pressure such that a safe quantity of gas would be released should a leak occur. If the amount falls below a certain threshold level, gas or fluid egress is presumed and the inflation process is halted.

Abstract: A catheter includes a first expandable membrane having a first pressurization limit and a second expandable membrane, having a second pressurization limit, wherein the second pressurization limit is greater than the first pressurization limit, the first expandable membrane defines a cooling chamber, the second expandable membrane being disposed around the first expandable membrane to define an junction therebetween. The catheter includes a coolant injection lumen in fluid communication with the at least one fluid inlet port and the cooling chamber, and a primary coolant return lumen in fluid communication with the at least one fluid outlet port and the cooling chamber. The coolant injection tube, the cooling chamber, and the primary coolant return lumen define a first fluid pathway. The catheter further includes a secondary coolant return lumen in fluid communication with the at least one fluid outlet port and the junction. The junction and the secondary coolant return lumen define a second fluid pathway.

Abstract: A medical device includes a steering element defining a passage for a guide wire. A fluid injection tube defining a proximal and a distal end is also included, wherein a portion of the fluid injection tube is contoured about a portion of the steering element. A plurality of injection ports may be disposed in the portion of the fluid injection tube contoured about the steering element.

Abstract: A medical apparatus and system for determining contact assessment includes a catheter having an elongate body having a proximal end, a distal end opposite the proximal end, and defining an injection lumen and an exhaust lumen, an expandable membrane defining a cooling chamber disposed at a point along the elongate body, the cooling chamber in fluid communication with the injection lumen and the exhaust lumen, and a contact assessment element which may be a temperature sensor located proximate the coolant return lumen for measuring an internal temperature of the chamber. The system may include the catheter, a console having a fluid supply, an exhaust path and at least one control mechanism operationally coupled to the temperature sensor for processing a temperature signal received from the temperature sensor. The apparatus and system can also have multiple electrodes to measure and process various impedances to determine contact assessment.