Celsius Control system.

Abstract

The Celsius Control system (Innercool Therapies, Inc.) is an intravascular cooling catheter system consisting of the Celsius Control catheter,circulating set, and the Celsius Control console. Based on clinical studies, the system has recently received Food and Drug Administration approval for use as a device to induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and recovery/intensive care, and is currently being marketed in the 10.7 Fr and 14 Fr catheter sizes. It works to regulate temperature by circulating sterile saline through the Celsius Control console, which contains an integrated assembly comprising a temperature and pressure sensing block,supply and return lines, and a 20-{m} filter with connective tubing and an independent heat exchanger and pump. The system relies on digital core temperature readings from either esophageal or bladder temperature probes. After the system is turned on, approximately 150 mL of sterile saline solution is pumped through the console and is cooled to achieve the preset temperature. This cooled saline subsequently circulates from the console through the catheter in a closed-loop manner. The distal portion of the catheter incorporates a flexible distal metallic heat transfer element that is designed to allow for direct exchange of thermal energy with blood circulating around the catheter.