About one thousand patients suffer cardiac arrest in United States each day, only 11% of them survive. Therapeutic hypothermia (TH) has been demonstrated to increase the survival rate and neurological outcome of the cardiac arrest patients. Due to the limitation of existing cooling methods, such as slow cooling speed and/or late induction of hypothermia, none of these methods can meet the key requirements (i.e. the timing and speed with which the hypothermia to be induced) to gain the optimal benefits of hypothermia. It results in less than 10% of eligible patients actually benefiting from hypothermia treatment. Buy Time Medical (BTM) invented a novel cooling device to infuse ice slurry, a specially processed micro-particulate ice, into the blood vessel of cardiac arrest patient for rapid organ or body cooling. Pilot large animal experiment demonstrated that 2L ice slurry infusion can potentially cool the entire body of an adult human at a rate of 18.2°C/hr, which is several folds faster than any other existing cooling methods. Using BTMs innovated technology, ice slurry cooling device provides a new capability to induce hypothermia by paramedics to meet the timing and speed requirements for optimal outcome. Specific aims: In this phase I project, we will build a functional prototype of novel ice slurry cooling device for initiating hypothermia in pre-hospital settings, and test and verify its feasibility and safety in animal experiment using swine model. The specific aims are: 1) design and build a functional ice slurry cooling prototype with characteristics needed for pre-hospital settings; 2) test the functional prototype in lab settings to optimize the cooling process variables; 3) test the feasibility and safety of the functional prototype at a large animal lab; and 4) fine tune the prototype and cooling process. The Phase 1 research will verify the technical feasibility and safety of BTMs ice slurry cooling devices. The results will be used to support a Phase II grant application and research. Ultimately, we plan to commercialize ice slurry cooling device that will significantly improve the survival rate and neurological outcome of cardiac arrest and generate significant socio-economic value.
Public Health Relevance Statement: Project Narrative Mild therapeutic hypothermia has been demonstrated to improve the patient survival rate and neurological outcome of cardiac arrest, which a leading cause of death in the United States. This project will develop and test a new cooling device that will be able to induce hypothermia earlier and quicker after onset of cardiac arrest and verify its feasibility in animal study using a swine model. Commercialization of our medical device will have a significant improvement in saving lives of cardiac arrest patients and generate socio-economic value.
Project Terms: Adult; Adverse effects; Animal Experiments; Animals; Applications Grants; base; Biomedical Research; Blood Vessels; Body Temperature; Boston; Brain; Cause of Death; Characteristics; Clinical; commercialization; Computer software; design; Device Designs; Devices; economic value; Eligibility Determination; Environment; Family suidae; Freezing; Heart Arrest; Hemolysis; Hospitals; Ice; improved; induced hypothermia; Inferior; Infusion procedures; innovative technologies; Measurement; Medical; Medical Device; Methods; Modeling; natural hypothermia; Neurological outcome; novel; Organ; Outcome; Outcomes Research; Paramedical Personnel; Particulate; Patients; Performance; Phase; portability; Power Sources; Pre-hospital setting; Process; prototype; Research; Research Institute; safety and feasibility; Savings; Small Business Innovation Research Grant; socioeconomics; Speed; Survival Rate; System; Technology; Temperature; Testing; Therapeutic; therapy outcome; Thrombosis; Time; United States
