Hybernia Safety Catheter for Neuroprotection via Selective Hypothermia

Hybernia 安全导管通过选择性低温进行神经保护

• 批准号: 8002454
• 负责人: John Martin Pile-Spellman
• 金额: $ 38.44万
• 依托单位: HYBERNIA MEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8002454
• 关键词: Address; Adverse effects; Affect; Algorithms; Angioplasty; Animal Model; Animal Testing; Animals; Arteries; Asphyxia; Basic Science; Blood flow; Brain; Brain Aneurysms; Brain Injuries; Cardiac Surgery procedures; Cardiopulmonary Bypass; Carotid Arteries; Catheters; Cerebrum; Chills; Clinical Trials; Coagulation Process; Data; Development; Device Designs; Devices; Diagnostic; Engineering; Equipment; Excision; Family suidae; Freezing; Funding; Goals; Guidelines; Heart Arrest; Heating; Hematocrit procedure; Hemodilution; Human; Infarction; Infusion procedures; Injury; Intellectual Property; Ischemia; Ischemic Stroke; Liquid substance; Measurement; Measures; Medical; Metabolism; Methods; Modeling; Molecular; Monitor; Neonatal; Nervous System Trauma; Normal saline; Organ; Organ Temperatures; Outcome; Oxygen; Pathway interactions; Patients; Performance; Phase; Physiological; Procedures; Process; Production; Pump; Research; Research Design; Rest; Role; Safety; Series; System; Technology; Temperature; Testing; Therapeutic; Therapeutic procedure; Thrombectomy; Time; Tissues; Universities; Validation; Work; base; computerized; coronary angioplasty; cost; design; hypoxia neonatorum; improved; meetings; natural hypothermia; neuron loss; neuroprotection; phase 1 study; pre-clinical; prevent; prototype; public health relevance; research study; safety study; sensor; simulation; standard of care; thrombolysis

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.

描述（由申请人提供）：低温是一种有效的缺血性损伤神经保护治疗方法，适用于心肺转流、心脏骤停和新生儿缺氧。然而，目前的方法诱导全身低温，这需要大量的时间并具有相关的并发症。Hybernia Medical，LLC正在开发一种基于分配给哥伦比亚大学的知识产权（USPTO 20090018504）的设备，该设备通过颈动脉内输注冷生理液来诱导安全、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，解决固有的工程挑战，并在一系列监管动物研究中对其进行测试。第一年包括基础研究，设计和设计控制验证测试，涉及动物准备原型的生产。第2年包括原型在动物模型中的初始确认测试，有助于设计冻结。初步研究表明，虽然动脉内冷灌注可以迅速诱导局部脑低温，但其代价是血液稀释。初始模拟显示了导管绝缘、液体温度测量、液体混合、算法控制器在相关生理范围内的性能要求，这些要求是安全冷却组织和测量实时组织温度和自体血管血流所需的。Hybernia安全导管有可能使血管内诊断和治疗程序更安全。其被设想为在颈动脉支架植入术、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术中使用的导引导管。仍然有很大的机会使这些程序更安全。如果后续临床试验表明，使用Hybernia Safety导管替换常规导引导管可减轻血管内手术期间的缺血性损伤，则将带来巨大的社会效益和商业机会。 公共卫生相关性：据估计，每年进行超过350万例治疗性血管内手术。Hybernia安全导管有可能使这些手术（包括颈动脉支架植入术、脑动脉瘤治疗、血栓清除术和潜在的冠状动脉血管成形术和支架植入术）更加安全。如果后续的临床试验表明，用相对低成本的Hybernia安全导管替换传统设备可减轻血管内手术期间的脑损伤，那么这些患者将实现低温治疗的受益。