STTR Phase II: Intraventricular Cooling Catheter

Coolspine Llc, Woodbury CT

Investigators

Abstract

This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5). This Small Business Innovation Research Phase II project will build upon the success demonstrated in the Phase I program and further develop the Intraventricular Cooling Catheter, whose purpose is to induce localized therapeutic hypothermia while maintaining systemic normothermia and thus to act as a neuroprotective modality to mitigate brain injury in traumatic brain injury, and stroke, and post-cardiac arrest brain injury in humans. In Phase II our primary objectives are: 1) design and development of commercially viable prototypes of the system components (Controller and Catheter); 2) determination of system's range of effectiveness in cooling tissue in various regions of the brain (cooling map of brain); and 3) determination of system's safety and efficacy profile. Improvements will be developed to both the catheter and the controller based on our Phase I experience. Animal trials using a sheep model will be conducted to determine the system's performance and efficacy in brain application. Finally, an IDE safety trial will be conducted (in spine application). We anticipate that the results of this work will provide the foundation for this intraventricular cooling catheter to be used as an adjunct modality to other treatments for neuroprotection due to cerebral ischemia in stroke and traumatic brain injury, as well as in cardiovascular surgery. The broader impact of this Phase II work addresses the challenge of neurological deficits relating to cerebral ischemia. Cerebral ischemia reduces oxygen delivery to brain cells and initiates the process of cellular death. Stroke and Traumatic Brain Injury (TBI) are the two most prevalent causes of icshemic brain injury. 780,000 strokes occur annually in the United States with 87% of them being ischemic. Stroke is the third leading cause of death and the leading cause of disability. Additionally, stroke strikes blacks at a rate twice that of whites. TBI results in 235,000 hospitalizations each year and 50,000 deaths. The challenge of TBI has increased even more in the US military where, due to the nature of modern warfare, rates of brain injury have increased from 12%-14% to an estimated 22%. Neurological deficits from cerebral ischemia cry out for novel therapies. Over $119 billion in direct and indirect costs to society are incurred annually from Stoke and TBI, $68.9 billion for stroke and 60 billion for TBI. These diseases affect all sectors of society and the development of a novel device to induce localized hypothermia while maintaining systemic normothermia will have a significant impact on clinical practice.