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

 描述(由申请人提供)：该项目的目的是开发一种改进的、微创的治疗颅内动脉瘤的方法。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起。未破裂的动脉瘤出现在大约3%的普通人群中，破裂可能是毁灭性的，具有很高的发病率和死亡率。近年来，一种新型的微创血管内治疗动脉瘤的装置已经推向市场。这些装置被称为分流支架，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。网状物中的小孔阻止血液进入动脉瘤，这会导致困在动脉瘤内的血液变得停滞和凝结。然后，动脉瘤经历一个愈合的过程，支架充当重建载瘤动脉的支架。尽管他们取得了成功， 第一代分流装置有许多局限性，如延迟的动脉瘤闭塞，通常为数月，以及每个患者需要多个设备才能实现完全闭塞。在多达25%的患者中，完全闭塞从未实现。NeuroSigma的下一代流量分流器基于薄膜镍(TFN)技术。TFN是一种在硅片上制造的先进生物材料，它克服了与第一代流量分流器相关的许多限制。动物研究结果表明，与第一代装置相比，TFN血流分流装置具有更高的动脉瘤闭塞率和更快的载瘤动脉修复速度。该项目的目的是在这些有趣的发现的基础上开发一种“快速闭塞”血流分流器，在这种分流装置中，放置一个单一的装置就可以快速、明确地修复动脉瘤。在这个项目完成后，TFN血流分流器将准备开始首个人体研究，作为全球数百万患有颅内动脉瘤的改进治疗方法。

 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.