Hybernia Safety Catheter for Neuroprotection via Selective Hypothermia

描述（由申请人提供）：低温治疗是缺血性损伤的一种强有力的神经保护治疗方法，适用于体外循环、心脏骤停和新生儿缺氧。然而，目前的方法诱导全身低体温，这需要大量的时间和相关的并发症。Hybernia医疗有限责任公司正在开发一种基于哥伦比亚大学知识产权（USPTO 20090018504）的设备，该设备通过在颈动脉内注入冷生理液体来诱导安全、快速和选择性的器官低温，从而解决这些问题。拟议的项目是开发一种导管原型，解决固有的工程挑战，并在一系列监管动物研究中进行测试。第一年是由基础研究、设计和设计控制验证测试组成的，涉及到动物准备原型的生产。第二年由动物模型原型的初始验证测试组成，有助于设计冻结。初步研究表明，虽然动脉内冷输注可以迅速引起局部脑低温，但它是以血液稀释为代价的。初步仿真显示了导管绝缘、流体温度测量、流体混合、算法控制器在相关生理范围内的性能要求，需要安全冷却组织并测量实时组织温度和本地血管血流。Hybernia安全导管有可能使血管内诊断和治疗过程更安全。它被设想为颈动脉支架置入、脑动脉瘤治疗、血栓溶栓和血栓提取以及潜在的冠状动脉成形术和支架置入的引导导管。使这些程序更加安全仍有很大的机会。如果后续的临床试验表明，用Hybernia Safety导管代替常规导尿管可以减轻血管内手术过程中的缺血性损伤，将会有巨大的社会效益和商业机会。

DESCRIPTION (provided by applicant): Hypothermia is a powerful neuroprotective treatment for ischemic injury and is indicated for use in cardiopulmonary bypass, cardiac arrest, and neonatal hypoxia. However, current methods induce systemic hypothermia which requires significant time and has associated complications. Hybernia Medical, LLC is developing a device based on intellectual property assigned to Columbia University (USPTO 20090018504) that addresses these issues by inducing safe, rapid, and selective organ hypothermia through the intra-carotid infusion of cold physiologic fluids. The proposed project is to develop a catheter prototype that solves the inherent engineering challenges and tests it in a series of regulatory animal studies. Year 1 is composed of the basic research, design, and design control verification testing involved in the production of an animal ready prototype. Year 2 is composed of initial validation testing of the prototype in an animal model, contributing to design freeze. Preliminary studies show that while intra-arterial cold infusion can rapidly induce local brain hypothermia, it does so at the expense of hemodilution. Initial simulation have shown the performance requirements of the catheter insulation, fluid temperature measurements, fluid mixing, algorithm-controller over the pertinent physiological range, needed to safely cool tissues and measure the real-time tissue temperature and native vessel blood flow. The Hybernia Safety Catheter has the potential to make endovascular diagnostic and therapeutic procedures safer. It is envisioned as the guiding catheter used during carotid artery stenting, brain aneurysm treatment, clot thrombolysis and clot extraction, and potentially coronary angioplasty and stenting. There remains a significant opportunity to make these procedures safer. If subsequent clinical trials show that the replacement of routine guiding catheters with the Hybernia Safety catheter mitigates ischemic injury during endovascular procedures, there would be tremendous societal benefit and commercial opportunity. PUBLIC HEALTH RELEVANCE: It is estimated that more than 3.5 million therapeutic endovascular procedures are performed each year. The Hybernia Safety catheter has the potential to make these procedures, which include carotid artery stenting, brain aneurysm treatment, clot-removal, and potentially coronary angioplasty and stenting, significantly safer. If subsequent clinical trials show that the replacement of conventional equipment with the relatively low-cost Hybernia Safety Catheter mitigates brain injury during endovascular procedures, then the benefits of hypothermia therapy would be realized for these patients.