This Small Business Innovation Research (SBIR) Phase I project aims to demonstrate the feasibility and safety of inducing mild therapeutic hypothermia with an innovative esophageal cooling device. The use of mild therapeutic hypothermia to treat patients after resuscitation from cardiac arrest nearly doubles their chance of survival, but the difficulties associated with the use of existing methods for inducing hypothermia result in less than 10% of eligible patients actually receiving this treatment. The esophageal cooling device induces hypothermia through the esophagus and solves the problems of inefficiency and risk associated with existing approaches. This innovation provides high-efficiency heat transfer at the patient's core while maintaining gastric access to allow decompression, ensuring maintenance of mucosal contact and attainment of optimum heat transfer. The research objectives of the proposed activity are to demonstrate the feasibility and safety of this transformative approach in a swine model prior to developing a beta-prototype in a Phase II project. Swine will be treated with mild therapeutic hypothermia utilizing an alpha prototype device, after which histopathological analysis of the esophagus by a certified veterinarian will be undertaken to identify any adverse effects. It is anticipated that hypothermia will be induced successfully, with no adverse effects identified.
The broader impact/commercial potential of this project will be the lives saved in patients suffering cardiac arrest. The commercial potential of this technology is large because up to 1 million individuals in North America suffer cardiac arrest annually, and another 3 million suffer illnesses that appear to benefit from treatment with hypothermia. Successful commercialization of this transformative technology will result in an effective new tool to enhance the scientific and technological understanding of the benefits of hypothermia in stroke, trauma, and spinal cord injury, among other indications. The device's manufacturing cost is 12 times less than competitors' devices, allowing a margin that will compete effectively in the $1 billion annual market in patient temperature control while providing significant practical advantages to physicians. Because the device is more efficient than surface devices, does not obstruct access to the patient, replaces the standard nasogastric tube, is quick and easy to place, and eliminates the risks of infections, blood clots, and needlestick injuries, adoption will be widespread, resulting in significant societal impact by improving outcomes of cardiac arrest worldwide.
This Small Business Innovation Research Phase II project aims to develop the innovative esophageal cooling device (ECD) to treat patients with a cooling therapy called mild therapeutic hypothermia (cooling the patient down) to improve outcomes after critical illnesses, including heart attacks and strokes. Although mild therapeutic hypothermia nearly doubles the chances of a patient surviving after resuscitation from cardiac arrest, only a small percentage of eligible patients receive this treatment. This is in part because the existing devices for inducing hypothermia are inefficient, cumbersome, or pose risks to the patient or the healthcare provider (physician or nurse, generally). The ECD overcomes these problems by inducing hypothermia through the esophagus. This innovation allows for high-efficiency heat transfer at the patient’s core while maintaining gastric access to allow decompression, thus ensuring maintenance of mucosal contact and attainment of optimum heat transfer. The research objectives for the Phase I project were (1) to develop a prototype ECD, and (2) to test this device in a swine model prior to proceeding with further development in a Phase II project. The results of this project found that the prototype can induce and maintain mild therapeutic hypothermia in swine for 24 hours, and that the prototype causes no damage to the esophagus or the surrounding organs, as determined by histopathological analysis. The next stage of development, anticipated to occur in a Phase II project, are to (1) investigate design enhancements that maximize ease-of-use and safety while mitigating any risks of the ECD, (2) establish biocompatibility, sterility, and mechanical performance, and (3) validate the final design through human factors validation research before obtaining regulatory clearance for marketing. It is anticipated that the ECD will be biocompatible, safe, and easy to use by health care providers, and that the device will offer a significant advance in the field of patient temperature management. The broader impact/commercial potential of this project will be on the number of lives saved, not only of patients suffering cardiac arrest, but also patients with numerous other conditions. Over a half-million patients annually suffer cardiac arrest in the U.S., and another 3 million suffer illnesses such as stroke, trauma, and spinal cord injuries, which also appear to benefit from treatment with hypothermia. Emergency and critical care physicians, the ECD end-users, will value the technological advantages of the ECD, including its greater efficiency and safety compared with the surface warming and intravascular devices now available. Hospitals will value the ECD for its ease of staff training as well as its disposability and low cost. The ECD’s manufacturing cost allows a margin that will compete effectively in the $1.45+ billion annual U.S. market in patient temperature control. The ECD can be used in both a cooling and a warming mode, and enables accurate modulation of core temperature in a patient. The ability of the ECD to control body temperature within a narrow range also makes it an invaluable tool for research into the physiology of therapeutic hypothermia. This device may thus have far reaching societal, educational, and scientific benefits.
