Rapid Induction of Therapeutic Hypothermia Using Ice Slurry

项目摘要/摘要 意义：在美国，每天约有1000名患者心脏骤停，其中只有11%的人存活下来。 治疗性低温(TH)已被证明可以提高心脏的存活率和神经学预后。 逮捕病人。由于现有冷却方法的限制，例如冷却速度慢和/或诱导延迟 对于低温，这些方法都不能满足关键要求(即低温的时间和速度 被诱导)以获得体温过低的最佳益处。其结果是只有不到10%的符合条件的患者实际受益 来自低温治疗。Buy Time Medical(BTM)发明了一种新型的冷却装置，用于注入冰浆，一种特殊的 经过处理的微粒冰，进入心脏骤停患者的血管，用于快速器官或身体降温。试点规模大 动物实验表明，2L冰浆输注可能会以一定的速度冷却成年人的全身 18.2°C/小时，这比任何其他现有的冷却方法快几倍。利用BTM的创新技术，ICE 泥浆冷却装置提供了一种新的能力来诱导护理人员的低温，以满足时间和速度 对最佳结果的要求。具体目标：在这个一期工程中，我们将建造一个新型冰的功能原型 院前环境启动低温的浆液冷却装置，并在动物身上试验验证其可行性和安全性 用猪模型进行实验。具体目标是：1)设计并建造一台功能性冰浆冷却样机 院前设置所需的特性；2)在实验室设置中测试功能原型，以优化冷却流程 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)对原型进行微调 和冷却过程。第一阶段的研究将验证BTM的冰浆冷却设备的技术可行性和安全性。 结果将用于支持第二阶段赠款申请和研究。最终，我们计划将冰浆商业化 降温装置，将显著提高心脏骤停的存活率和神经预后，并产生 具有重大的社会经济价值。

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.