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: 9229076
• 负责人: DAVID F KALLMES
• 金额: $ 89.98万
• 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/9229076
• 关键词: Address; Aneurysm; Animal Model; Animals; Arteries; Biocompatible Materials; Biological; Blood; Blood Vessels; Clinic; Coagulation Process; Devices; Dimensions; Feedback; Film; General Population; Generations; Giant Intracranial Aneurysms; Goals; Growth; Head; Human; Implant; In Vitro; Industrialization; Industry Standard; Intracranial Aneurysm; Investigation; 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; Thinness; 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; preclinical development; 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）：本项目旨在开发一种用于颅内动脉瘤的改良微创治疗方法。颅内动脉瘤是由于血管壁薄弱而导致的头部血管的球形外囊。未破裂的动脉瘤约占一般人群的3%，破裂可能具有破坏性，发病率和死亡率较高。近年来，一种用于治疗动脉瘤的新型微创血管内器械已被引入市场。这些被称为血流转向支架的装置由管状金属网组成，并被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，这导致被困在动脉瘤内的血液停滞和凝结。然后，动脉瘤经历愈合的过程，支架作为支架用于重建载瘤动脉。尽管他们取得了成功， 第一代分流器受到许多限制，例如延迟的动脉瘤闭塞，通常在数月的数量级，并且每个患者需要多个装置来实现完全闭塞。在多达25%的患者中，从未实现完全闭塞。NeuroSigma的下一代血流导向装置基于薄膜镍钛合金（TFN）技术。TFN是一种在硅晶片上制造的先进生物材料，克服了与第一代血流导向装置相关的许多限制。动物研究结果表明，TFN Flow Diverter的动脉瘤闭塞率和载瘤动脉修复速度优于第一代器械。本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”血流导向装置，其中放置单个器械可实现快速、明确的动脉瘤修复。在本项目完成时，TFN Flow Diverter将准备好开始首次人体研究，作为全球数百万颅内动脉瘤患者的改进治疗。