Active mixing catheter for selective organ cooling

描述（由申请人提供）：中风是美国严重残疾的主要原因。虽然低温的神经保护能力已经被人们所知了几十年，但我们完全利用其保护能力的能力并不容易。该项目的目标是开发一种可以快速冷却大脑的冷却导管。现有的冷却导管是全身冷却的。因此，有两个因素降低了低温的有效性：1）全身的热惯性延迟了达到目标温度的时间，以及2）由于心血管和感染问题，目标温度高于最佳温度。我们的创新技术探索了另一种尚未探索的传热增强技术：主动混合。使用动态热交换表面而不是静态或静止的表面，我们打算创建一个导管，满足必要的冷却要求，同时仍然保持足够的血液灌注。假设20%的美国中风患者接受低温治疗，这些原型的预期市场为1.2亿至1.8亿美元。我们的I期可行性项目的具体目标如下：1）设计并构建2个冷却导管原型用于体外和体内试验，2）测试并评价原型的体外性能，3）测试并评价血管损伤和血液相容性方面的体内性能和安全性。使用一阶传热模型和现有的颈动脉血液动力学模型，设计将被转换为3D实体和制造。体外测试将在具有经证实的能量平衡准确性的实验台上进行。然后将有希望的体外原型用于中试动物研究，以证明在大型动物中的安全性和性能方面的可行性。将通过3个因素衡量器械性能：其冷却能力、不阻碍血流的能力以及安全操作的能力。

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.