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:
A system and method for controlling inflation, ablation, and deflation of a balloon catheter, including a catheter, a console having a pressurized gas or liquid inflation source, and an umbilical system to deliver coolant. A pressure-sensing device monitors pressure and volume within the catheter. During inflation, pressure and/or volume of fluid within the balloon is maintained to provide sufficient pressure against the target region. Inflation pressure is limited so a safe quantity of gas would be released should a leak occur. If the amount falls below a threshold, fluid egress is presumed, halting inflation. An intermediate console having a shut-off valve may be coupled between the console and catheter to interrupt coolant flow upon leak detection. The balloon can be re-inflated by a separate coolant source in the intermediate station or by a syringe. A second balloon may envelope the first balloon, providing a safety vacuum between the two balloons.