SBIR-STTR Award

Stroke is the leading cause of serious disability in the U.S. While the neuroprotective power of hypothermia has been known decades, our ability to fully harness its protective power has not come easily. The objective of this project is to develop a cooling catheter that can rapidly cool the brain. Existing cooling catheters cool systemically. As a result, two factors reduce the effectiveness of hypothermia: 1) the thermal inertia of the whole body delays the time to target temperatures, and 2) the target temperatures are warmer than optimal temperatures because of cardiovascular and infection concerns. Our innovative technology explores another heat transfer augmentation technique that has not been explored: active mixing. Using dynamic heat exchange surfaces instead of static or motionless ones, we intend to create a catheter that meets the necessary cooling requirements while still maintaining adequate blood perfusion. Assuming 20% of U.S. stroke victims are open to hypothermia treatment, the anticipated market for these prototypes is 120-180 million dollars. The specific aims of our Phase I feasibility project are the following: 1) design and build two cooling catheter prototypes for in vitro and in vivo testing, 2) test and evaluate the in vitro performance of the prototypes, and 3) test and evaluate the in vivo performance and safety, in terms of vessel damage & hemocompatability. Using a first order heat transfer model and an existing carotid artery hemodynamic model, designs will be transformed into 3D solids and manufactured. In vitro testing will follow on a bench with demonstrated energy balance accuracy. Promising in vitro prototypes will then be used in a pilot animal study to demonstrate feasibility in terms of safety and performance in a large animal. Device performance will be gauged by three factors: its ability to cool, its ability to not obstruct blood flow, and its ability to operate safely

Over one million acute myocardial infarctions (AMI) occur each year in the U.S. Percutaneous transluminal coronary intervention (PTCI) is the preferred treatment. Despite the overall effectiveness of PTCI, in the year following an initial heart attack, 30% of patients die. Animal and clinical studies have shown that whole-body cooling devices used together with PTCI can reduce heart-tissue damage compared to PTCI alone by 40-50%. These devices have two components, a cooling catheter that is placed in the inferior vena cava (IVC) and a cooling console that circulates coolant through the catheter. The catheter cools the whole-body by cooling the entire blood supply. As a result of the body's thermal inertia and thermoregulation system, achieving mild hypothermia (33C) takes 30 minutes to 1 hour. We are developing a new blood cooling catheter (CoolGuide) that delivers rapid focused cooling to the heart while leaving the rest of the body at normal temperature. CoolGuide aims to 1) simplify the cooling procedure, 2) reduce organ cooling time to under 5 min and 3) avoid whole-body cooling complications. A control console that circulates coolant and blood through the catheter will be part of the complete product. Catheter and console will be marketed together for use with PTCI. CoolGuide is a hybrid catheter, combining the functionality of existing guide catheters with the ability to provide cardioprotection with regional hypothermia. It uses a tri-lumen Teflon inner core, providing pathways for coolant flow and blood flow. Blood flows through the Coolguide directly into the coronary arteries. Phase I prototypes have demonstrated feasibility, using a large (70kg) pig model; these prototypes create regional mild hypothermia in 4-6 minutes. In Phase II we will optimize the Coolguide catheter and console, demonstrate hemocompatibility for the CoolGuide system during in vivo use with large swine, and demonstrate CoolGuide's ability to protect heart tissue. This in vivo data will be used to gain FDA approval for an initial human trial. Specific Aims:1.Design, build, and test refined CoolGuide prototypes for in vitro and in vivo testing, 2.Design, build, and test a refined CoolGuide console for in vitro and in vivo testing, 3.Test for hemocompatibility,4.Demonstrate the tissue salvage efficacy of the CoolGuide system (console and catheter) in large swine. The FDA has and will continue to provide guidance for CoolGuide in vivo testing. Relevance: The total cost associated with coronary disease is nearly 150 billion dollars. The fundamental challenge to improving patient outcome for heart attacks is minimizing ischemic tissue damage. This project seeks to harness a new therapeutic technology for focused organ cooling called CoolGuide to accomplish that goal. American Heart Association 2005 statistics show that in the first year following an initial heart attack, 25% of men and 38% of women die. Recent clinical studies have shown that mild whole body hypothermia (~34C) can salvage heart tissue after a heart attack. FocalCool, LLC seeks to develop a novel cooling catheter that cools heart tissue without the complications of whole-body cooling.

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