Active mixing catheter for selective organ cooling

描述(申请人提供)：中风是美国严重残疾的主要原因。虽然低温的神经保护作用几十年来就已为人所知，但我们充分利用其保护作用的能力来之不易。该项目的目标是开发一种能够快速冷却大脑的冷却导管。现有的冷却导管是系统冷却的。因此，有两个因素降低了低温的有效性：1)全身的热惯性推迟了达到目标温度的时间，2)出于心血管和感染的考虑，目标温度比最佳温度更热。我们的创新技术探索了另一种尚未被探索的强化传热技术：主动混合。使用动态热交换面，而不是静态或静止的热交换面，我们打算创造一种在满足必要的冷却要求的同时仍保持足够的血液灌流的导管。假设20%的美国中风患者愿意接受低温治疗，这些原型产品的预期市场价值为1.2亿至1.8亿美元。我们第一阶段可行性项目的具体目标如下：1)设计和制造2个用于体外和体内测试的冷却导管原型，2)测试和评估原型的体外性能，以及3)从血管损伤和血液相容性方面测试和评估体内性能和安全性。使用一阶传热模型和现有的颈动脉血流动力学模型，设计将转化为3D实体并进行制造。体外测试将在长凳上进行，以证明能量平衡的准确性。有希望的体外原型随后将用于试验性动物研究，以证明在大型动物身上的安全性和性能方面的可行性。设备的性能将通过3个因素来衡量：它的冷却能力，它不阻碍血液流动的能力，以及它的安全操作能力。

DESCRIPTION (provided by applicant): Stroke is the leading cause of serious disability in the U.S. While the neuroprotective power of hypothermia has been known decades, our ability to fully harness its protective power has not come easily. The objective of this project is to develop a cooling catheter that can rapidly cool the brain. Existing cooling catheters cool systemically. As a result, 2 factors reduce the effectiveness of hypothermia: 1) the thermal inertia of the whole body delays the time to target temperatures, and 2) the target temperatures are warmer than optimal temperatures because of cardiovascular and infection concerns. Our innovative technology explores another heat transfer augmentation technique that has not been explored: active mixing. Using dynamic heat exchange surfaces instead of static or motionless ones, we intend to create a catheter that meets the necessary cooling requirements while still maintaining adequate blood perfusion. Assuming 20% of U.S. stroke victims are open to hypothermia treatment, the anticipated market for these prototypes is $120-180 million dollars. The specific aims of our Phase I feasibility project are the following: 1) design and build 2 cooling catheter prototypes for in vitro and in vivo testing, 2) test and evaluate the in vitro performance of the prototypes, and 3) test and evaluate the in vivo performance and safety, in terms of vessel damage & hemocompatability. Using a first order heat transfer model and an existing carotid artery hemodynamic model, designs will be transformed into 3D solids and manufactured. In vitro testing will follow on a bench with demonstrated energy balance accuracy. Promising in vitro prototypes will then be used in a pilot animal study to demonstrate feasibility in terms of safety and performance in a large animal. Device performance will be gauged by 3 factors: its ability to cool, its ability to not obstruct blood flow, and its ability to operate safely.