Preclinical Testing of a Novel Flow Diverting Stent for Treating Intracranial Aneurysms

治疗颅内动脉瘤的新型血流转向支架的临床前测试

• 批准号: 9046467
• 负责人: DAVID F KALLMES
• 金额: $ 107.27万
• 依托单位: NEUROSIGMA, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-15 至 2019-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9046467
• 关键词: Address; Aneurysm; Animal Model; Animals; Arteries; Biocompatible Materials; Biological; Blood; Blood Vessels; Clinic; Coagulation Process; Development; Devices; Feedback; Film; General Population; Generations; Giant Intracranial Aneurysms; Goals; Growth; Head; Healed; Human; Implant; In Vitro; Industry Standard; Intracranial Aneurysm; Marketing; Metals; Methods; Morbidity - disease rate; Neck; Parents; Patients; Performance; Phase; Preclinical Testing; Process; Program Development; Risk; Rupture; Silicon; Small Business Technology Transfer Research; Stents; Tail; Technology; Testing; Time; Tissues; Tubular formation; base; commercialization; density; follow-up; healing; human study; implantation; improved; improved outcome; meetings; minimally invasive; mortality; neurovascular; next generation; nitinol; novel; pre-clinical; prevent; prototype; public health relevance; reconstruction; repaired; scaffold; success; uptake

 DESCRIPTION (provided by applicant): The purpose of this project is to develop an improved, minimally-invasive treatment for intracranial aneurysms. Intracranial aneurysms are spherical outpouchings of blood vessels in the head that result from weakness in the vessel wall. Unruptured aneurysms are present in approximately 3% of the general population, and rupture can be devastating with a high morbidity and mortality. In recent years a new type of minimally- invasive endovascular device to treat aneurysms has been introduced to the market. These devices, known as flow diverting stents, are composed of a tubular metal mesh and are placed in the parent artery to cover the neck of the aneurysm being treated. The small pores in the mesh prevent blood from entering the aneurysm, which causes blood trapped inside the aneurysm to become stagnant and clot. The aneurysm then undergoes a process of healing with the stent acting as a scaffold for reconstruction of the parent artery. Despite their success, first-generation flow diverters suffer from a number of limitations such as delayed aneurysm occlusion, often on the order of months, and the need for multiple devices per patient to achieve complete occlusion. In as many as 25% of patients complete occlusion is never achieved. NeuroSigma's next generation flow diverter is based on Thin Film Nitinol (TFN) technology. TFN is an advanced biomaterial fabricated on silicon wafers that overcomes many of the limitations associated with first-generation flow diverters. Results from animal studies suggest that the TFN flow diverter gives superior rates of aneurysm occlusion and faster parent artery repair than first-generation devices. The purpose of this project is to build upon these intriguing findings an develop a "rapid occlusion" flow diverter, where placement of a single device results in speedy, definitive aneurysm repair. At the completion of this project the TFN flow diverter will be ready t begin first- in-human studies as an improved treatment for the millions who suffer from intracranial aneurysms worldwide.

 描述（由申请人提供）：该项目的目的是开发一种改进的微创治疗颅内动脉瘤。颅内动脉瘤是由于血管壁薄弱而导致的头部血管的球形突出。大约占总人口的 3%，破裂可能是毁灭性的，具有高发病率和死亡率，是近年来出现的一种新型破裂。用于治疗动脉瘤的微创血管内装置已被引入市场，这些装置被称为血流转向支架，由管状金属网组成，放置在载瘤动脉中以覆盖正在治疗的动脉瘤的颈部。网状结构中的孔隙可防止血液进入动脉瘤，从而导致动脉瘤内的血液停滞并凝结，然后动脉瘤会经历愈合过程。尽管支架作为载瘤动脉重建的支架取得了成功， 第一代分流器存在许多局限性，例如动脉瘤闭塞延迟，通常需要数月的时间，并且每个患者需要多个装置才能实现完全闭塞，而多达 25% 的患者从未实现完全闭塞。 NeuroSigma 的下一代分流器基于薄膜镍钛诺 (TFN) 技术，TFN 是一种在硅晶片上制造的先进生物材料，克服了与第一代流量相关的许多限制。动物研究结果表明，与第一代装置相比，TFN 分流器具有更高的动脉瘤闭塞率和更快的载瘤动脉修复速度。该项目的目的是基于这些有趣的发现，开发一种“快速闭塞”分流器。 ，其中放置单个装置可实现快速、明确的动脉瘤修复。该项目完成后，TFN 分流器将准备好开始首次人体研究，作为对数百万动脉瘤患者的改进治疗。来自世界各地的颅内动脉瘤。