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（由适用提供）：该项目的目的是为颅内动脉瘤开发改进的，最小的侵入性治疗方法。颅内动脉瘤是由于血管壁无力而导致的血管的球形外套。大约3％的一般人群中，动脉瘤未破裂的动脉瘤可能会造成高发病率和死亡率造成破坏。近年来，已经引入了一种新型的微创血管内静脉内部的动脉瘤装置。这些设备被称为流动支架，由结节金属网格组成，并放置在母动脉中，以覆盖正在处理的动脉瘤的颈部。网眼中的小孔防止血液进入动脉瘤，这会导致被困在动脉瘤内的血液停滞不前。然后，动脉瘤经历了一个愈合的过程，支架充当父母动脉重建的脚手架。尽管他们成功了 第一代流量分流器遭受了许多局限性，例如延迟的动脉瘤阻塞，通常是按几个月的时间，并且需要每个患者多种设备以实现完全闭塞。在多达25％的患者中，从未实现完全闭塞的患者。 Neurosigma的下一代流动分流器基于薄膜Nitinol（TFN）技术。 TFN是一种在硅波上制造的高级生物材料，它克服了与第一代流动分流相关的许多局限性。动物研究的结果表明，与第一代设备相比，TFN流动分流器给出的动脉瘤阻塞和更快的母体动脉修复速率更高。该项目的目的是建立在这些有趣的发现上，开发了“快速遮挡”流动分流器，其中放置单个设备会导致快速，确定的动脉瘤修复。该项目完成后，TFN流量分流将准备就绪开始，开始了先进的人类研究，这是对全球颅内动脉瘤的数百万的改进治疗方法。