Rapid Induction of Therapeutic Hypothermia Using Ice Slurry

使用冰浆快速诱导治疗性低温

• 批准号: 9407256
• 负责人: Yue Wu
• 金额: $ 22.5万
• 依托单位: BUY TIME MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2019-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9407256
• 关键词: Adult; Adverse effects; Animal Experiments; Animals; Applications Grants; Biomedical Research; Blood Vessels; Body Temperature; Boston; Brain; Cause of Death; Characteristics; Clinical; Computer software; Device Designs; Devices; Eligibility Determination; Environment; Family suidae; Freezing; Heart Arrest; Hemolysis; Hospitals; Ice; Inferior; Infusion procedures; Measurement; Medical; Medical Device; Methods; Modeling; Neurological outcome; Organ; Outcome; Outcomes Research; Paramedical Personnel; Particulate; Patients; Performance; Phase; Power Sources; Pre-hospital setting; Process; Research; Research Institute; Savings; Small Business Innovation Research Grant; Speed; Survival Rate; System; Technology; Temperature; Testing; Therapeutic; Thrombosis; Time; United States; base; commercialization; design; economic value; improved; induced hypothermia; innovative technologies; natural hypothermia; novel; portability; prototype; safety and feasibility; socioeconomics; therapy outcome

Project Summary/Abstract Significance: 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 BTM’s 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 BTM’s 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.

项目概要/摘要 意义：美国每天约有一千名患者心脏骤停，其中只有 11% 存活。 低温治疗 (TH) 已被证明可以提高心脏病患者的存活率和神经系统结果 逮捕病人。由于现有冷却方法的限制，例如冷却速度慢和/或延迟诱导 但这些方法都不能满足低温的关键要求（即低温的时机和速度） 被诱导）以获得低温的最佳益处。结果只有不到 10% 的符合条件的患者真正受益 来自低温治疗。 Time Medical (BTM) 发明了一种新型冷却装置来注入冰浆，这是一种特殊的冰浆冷却装置。 加工后的微粒冰，进入心脏骤停患者的血管中，对器官或身体进行快速冷却。飞行员大号 动物实验表明，2L冰浆输注可以使成年人的整个身体以一定的速度冷却 18.2°C/小时，比任何其他现有冷却方法快几倍。利用BTM的创新技术，ice 浆液冷却装置提供了一种新的能力，可以让护理人员诱导体温降低，以满足时间和速度的要求 最佳结果的要求。具体目标：在一期项目中，我们将构建新型冰的功能原型 用于院前环境中启动低温的浆液冷却装置，并在动物身上测试和验证其可行性和安全性 使用猪模型进行实验。具体目标是：1）设计并构建功能性冰浆冷却原型 院前环境所需的特征； 2) 在实验室环境中测试功能原型以优化冷却过程 变量； 3）在大型动物实验室测试功能原型的可行性和安全性； 4）微调原型 和冷却过程。第一阶段研究将验证BTM冰浆冷却装置的技术可行性和安全性。 研究结果将用于支持第二阶段拨款申请和研究。最终，我们计划将冰浆商业化 冷却装置将显着提高心脏骤停的存活率和神经系统结果，并产生 显着的社会经济价值。