High Efficiency Hypo/Hyperthermia System

高效低温/高温系统

• 批准号: 6949645
• 负责人: William J. Ohley
• 金额: $ 59.16万
• 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 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6949645
• 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）： 突然心脏骤停仍然是一个严重的公共卫生问题。每年在美国大约有350,000名个人陷入困境，总生存率仅为5％。即使目前可获得最先进的护理，即使有25％的生存率似乎也是可能的最佳情况。显然需要改善处理这种情况的疗法。先前的研究表明，在心脏骤停期间和后提供的中等温度（约3-5度C）可以降低包括大脑在内的重要器官的损害水平。但是，用于冷却的常规无创手段（例如充满水的冷却毯和冷空气覆盖物）的速度太慢，无法进行最佳治疗。此外，它们不适合在心肺复苏（CPR）进行时使用。 在最近的一系列实验中，我们已经证明，可以使用系统（Thermosuit系统或TSS）来实现全身冷却，该系统将一层薄薄的冷水循环到实验动物的皮肤表面上。结果表明该技术在降低核心温度方面非常有效。例如，我们可以在30分钟内平均导致镇静动物的核心温度下降8度（n = 6，平均质量= 37kg），因此在此处提出的工作中，我们寻求在第I阶段完成的结果，以便A可以使用该技术开发原型临床设备。该西装也可以在心肺复苏期间使用。 该提案将[1]开发一个组合的西服设计和温度控制系统，以快速改变具有正常和受损的循环系统动物的体温。 [2]开发基于冰的自我包含的储能系统。[3]开发一个操作员界面和西服系统，可在急诊室临床使用。 [4]向FDA提交文件，以接收IDE进行临床测试。