Research Project
8002454
DESCRIPTION (provided by applicant): Hypothermia is a powerful neuroprotective treatment for ischemic injury and is indicated for use in cardiopulmonary bypass, cardiac arrest, and neonatal hypoxia. However, current methods induce systemic hypothermia which requires significant time and has associated complications. Hybernia Medical, LLC is developing a device based on intellectual property assigned to Columbia University (USPTO 20090018504) that addresses these issues by inducing safe, rapid, and selective organ hypothermia through the intra-carotid infusion of cold physiologic fluids. The proposed project is to develop a catheter prototype that solves the inherent engineering challenges and tests it in a series of regulatory animal studies. Year 1 is composed of the basic research, design, and design control verification testing involved in the production of an animal ready prototype. Year 2 is composed of initial validation testing of the prototype in an animal model, contributing to design freeze. Preliminary studies show that while intra-arterial cold infusion can rapidly induce local brain hypothermia, it does so at the expense of hemodilution. Initial simulation have shown the performance requirements of the catheter insulation, fluid temperature measurements, fluid mixing, algorithm-controller over the pertinent physiological range, needed to safely cool tissues and measure the real-time tissue temperature and native vessel blood flow. The Hybernia Safety Catheter has the potential to make endovascular diagnostic and therapeutic procedures safer. It is envisioned as the guiding catheter used during carotid artery stenting, brain aneurysm treatment, clot thrombolysis and clot extraction, and potentially coronary angioplasty and stenting. There remains a significant opportunity to make these procedures safer. If subsequent clinical trials show that the replacement of routine guiding catheters with the Hybernia Safety catheter mitigates ischemic injury during endovascular procedures, there would be tremendous societal benefit and commercial opportunity. PUBLIC HEALTH RELEVANCE: It is estimated that more than 3.5 million therapeutic endovascular procedures are performed each year. The Hybernia Safety catheter has the potential to make these procedures, which include carotid artery stenting, brain aneurysm treatment, clot-removal, and potentially coronary angioplasty and stenting, significantly safer. If subsequent clinical trials show that the replacement of conventional equipment with the relatively low-cost Hybernia Safety Catheter mitigates brain injury during endovascular procedures, then the benefits of hypothermia therapy would be realized for these patients.
