Hybernia Safety Catheter for Neuroprotection via Selective Hypothermia

说明(申请人提供)：低温是一种有效的神经保护治疗方法，可用于体外循环、心脏骤停和新生儿缺氧。然而，目前的方法导致全身低温，这需要很长的时间和相关的并发症。海伯尼亚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的设备(美国专利商标局20090018504)，通过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来解决这些问题。拟议的项目是开发一种导管原型，以解决固有的工程挑战，并在一系列规律性动物研究中对其进行测试。第一年由基础研究、设计和设计控制验证测试组成，这些测试涉及动物就绪原型的生产。第二年包括在动物模型中对原型进行初步验证测试，这有助于设计冻结。初步研究表明，尽管动脉内冷输注可以迅速导致局部脑低温，但这是以血液稀释为代价的。初步模拟表明，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，需要安全地冷却组织并测量实时组织温度和自然血管血流量。海伯尼亚安全导管具有使血管内诊断和治疗过程更安全的潜力。它被设想为用于颈动脉支架置入术、脑动脉瘤治疗、血栓溶解和血栓提取，以及潜在的冠状动脉血管成形术和支架植入的引导导管。让这些程序变得更安全的机会仍然很大。如果随后的临床试验表明，用Hybernia Safe导管取代常规的导尿管可以减轻血管内手术中的缺血性损伤，将会有巨大的社会效益和商业机会。 公共卫生相关性：据估计，每年进行的血管内治疗性手术超过350万例。海伯尼亚安全导管有可能使这些手术变得更加安全，包括颈动脉支架植入、脑动脉瘤治疗、血栓清除，以及潜在的冠状动脉血管成形术和支架植入。如果随后的临床试验表明，用成本相对较低的海伯尼亚安全导管取代传统设备可以减轻血管内手术期间的脑损伤，那么低温治疗的好处将对这些患者实现。

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.