High Efficiency Hypo/Hyperthermia System

高效低温/高温系统

• 批准号: 6790470
• 负责人: William J. Ohley
• 金额: $ 60.15万
• 依托单位: LIFE RECOVERY SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-02-01 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6790470
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; body temperature; body temperature regulation; cardiopulmonary resuscitation; cardiovascular disorder therapy; clinical research; emergency care; heart arrest; hemodynamics; human subject; hyperthermia; induced hypothermia; swine

DESCRIPTION (provided by applicant): Sudden cardiac arrest remains a serious public health issue. Approximately 350,000 individuals are stricken in the U.S. annually, with overall survival rates on the order of only 5%. Even with the immediate availability of the most advanced care currently available, a survival rate of 25% appears to be the probable best case scenario. Improved therapies to deal with this situation are clearly needed. Prior studies have shown that moderate hypothermia (approximately 3-5 degrees C) provided during and after cardiac arrest can reduce the level of damage to vital organs, including the brain. However, conventional noninvasive means which are available for cooling (such as water-filled cooling blankets and cool air-emitting coverings) are too slow for optimal treatment. Furthermore, they are not well-suited to being used during administration of cardiopulmonary resuscitation (CPR). In a series of recent experiments we have demonstrated that whole body cooling can be achieved using a system (the ThermoSuit System, or TSS) which circulates a thin layer of cold water over the skin surface of an experimental animal. The results indicate that the technique is extremely effective in reducing core temperature. For example we can cause an average 8 degree drop in the core temperature of sedated animals (n=6, mean mass = 37Kg) in 30 minutes Thus in the work proposed here, we seek to extend the results completed in Phase I so that a prototype clinical device can be developed using this technology. This suit can also be used during CPR. The proposal will [1] Develop a combined suit design and temperature control system to rapidly alter body temperature in animals with normal and compromised circulatory systems. [2] Develop a self contained energy storage system based on ice.[3] Develop an operator interface and suit system to be used clinically in the emergency room. [4] Submit documentation to the FDA to receive an IDE for clinical testing.

描述（由申请人提供）： 心脏骤停仍然是一个严重的公共卫生问题。美国每年约有 350,000 人患病，总体存活率仅为 5%。即使可以立即获得目前最先进的护理，25% 的生存率似乎也是可能的最佳情况。显然需要改进的疗法来应对这种情况。先前的研究表明，心脏骤停期间和之后提供的中度低温（约 3-5 摄氏度）可以减少对包括大脑在内的重要器官的损害程度。然而，可用于冷却的传统非侵入性方法（例如充满水的冷却毯和冷气排放覆盖物）对于最佳治疗来说太慢。此外，它们不太适合在心肺复苏（CPR）过程中使用。 在最近的一系列实验中，我们证明可以使用一个系统（ThermoSuit 系统，或 TSS）来实现全身冷却，该系统在实验动物的皮肤表面上循环一层薄薄的冷水。结果表明该技术对于降低核心温度非常有效。例如，我们可以在 30 分钟内使镇静动物（n = 6，平均质量 = 37 公斤）的核心温度平均下降 8 度。因此，在这里提出的工作中，我们寻求扩展第一阶段完成的结果，以便可以使用该技术开发原型临床设备。该套装也可在心肺复苏期间使用。 该提案将[1]开发一种组合式防护服设计和温度控制系统，以快速改变循环系统正常和受损的动物的体温。 [2] 开发基于冰的自给式储能系统。 [3]开发用于急诊室临床的操作员界面和套装系统。 [4] 向 FDA 提交文件以获得用于临床测试的 IDE。