STTR Phase II: Intraventricular Cooling Catheter

该奖项是根据2009年美国复苏和再投资法案(公共法律111-5)资助的。这个小企业创新研究第二阶段项目将在第一阶段计划所展示的成功的基础上，进一步开发脑室内冷却导管，其目的是在保持全身常温的同时诱导局部治疗性低温，从而作为一种神经保护方式，减轻人类创伤性脑损伤、中风和心脏骤停后脑损伤的脑损伤。在第二阶段，我们的主要目标是：1)设计和开发商业上可行的系统组件原型(控制器和导管)；2)确定系统在冷却大脑不同区域组织方面的有效性范围(大脑冷却图谱)；以及3)确定系统的安全性和有效性。我们将根据第一阶段的经验对导管和控制器进行改进。将使用绵羊模型进行动物试验，以确定该系统在大脑应用中的性能和有效性。最后，将进行IDE安全性测试(在脊柱应用中)。我们预计，这项工作的结果将为这种脑室内冷却导管用作中风和创伤性脑损伤以及心血管手术中因脑缺血引起的神经保护的其他治疗的辅助手段奠定基础。这项第二阶段工作的更广泛影响解决了与脑缺血相关的神经功能障碍的挑战。脑缺血减少了对脑细胞的氧气输送，并启动了细胞死亡的过程。卒中和创伤性脑损伤是缺血性脑损伤最常见的两种原因。美国每年发生780,000例中风，其中87%是缺血性中风。中风是导致死亡的第三大原因，也是导致残疾的首要原因。此外，黑人中风的发病率是白人的两倍。TBI每年导致235,000人住院，50,000人死亡。由于现代战争的性质，脑损伤的发生率从12%-14%增加到了估计的22%，这对美国军队来说是更大的挑战。脑缺血导致的神经缺陷迫切需要新的治疗方法。斯托克和TBI每年给社会带来的直接和间接成本超过1190亿美元，中风和TBI分别为689亿美元和600亿美元。这些疾病影响到社会的各个方面，开发一种新的装置来诱导局部低温，同时保持全身常温，将对临床实践产生重大影响。

This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5).This Small Business Innovation Research Phase II project will build upon the success demonstrated in the Phase I program and further develop the Intraventricular Cooling Catheter, whose purpose is to induce localized therapeutic hypothermia while maintaining systemic normothermia and thus to act as a neuroprotective modality to mitigate brain injury in traumatic brain injury, and stroke, and post-cardiac arrest brain injury in humans. In Phase II our primary objectives are: 1) design and development of commercially viable prototypes of the system components (Controller and Catheter); 2) determination of system's range of effectiveness in cooling tissue in various regions of the brain (cooling map of brain); and 3) determination of system's safety and efficacy profile. Improvements will be developed to both the catheter and the controller based on our Phase I experience. Animal trials using a sheep model will be conducted to determine the system's performance and efficacy in brain application. Finally, an IDE safety trial will be conducted (in spine application). We anticipate that the results of this work will provide the foundation for this intraventricular cooling catheter to be used as an adjunct modality to other treatments for neuroprotection due to cerebral ischemia in stroke and traumatic brain injury, as well as in cardiovascular surgery.The broader impact of this Phase II work addresses the challenge of neurological deficits relating to cerebral ischemia. Cerebral ischemia reduces oxygen delivery to brain cells and initiates the process of cellular death. Stroke and Traumatic Brain Injury (TBI) are the two most prevalent causes of icshemic brain injury. 780,000 strokes occur annually in the United States with 87% of them being ischemic. Stroke is the third leading cause of death and the leading cause of disability. Additionally, stroke strikes blacks at a rate twice that of whites. TBI results in 235,000 hospitalizations each year and 50,000 deaths. The challenge of TBI has increased even more in the US military where, due to the nature of modern warfare, rates of brain injury have increased from 12%-14% to an estimated 22%. Neurological deficits from cerebral ischemia cry out for novel therapies. Over $119 billion in direct and indirect costs to society are incurred annually from Stoke and TBI, $68.9 billion for stroke and 60 billion for TBI. These diseases affect all sectors of society and the development of a novel device to induce localized hypothermia while maintaining systemic normothermia will have a significant impact on clinical practice.