Collagen-Based Template for Treatment /Cerebral Aneurysm

用于治疗/脑动脉瘤的胶原蛋白模板

• 批准号: 6621861
• 负责人: SHU-TUNG T LI
• 金额: $ 16.2万
• 依托单位: COLLAGEN MATRIX, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6621861
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; blood vessel prosthesis; cerebral aneurysm; cerebrovascular surgery; collagen; implant; laboratory rabbit; medical implant science; tissue engineering

The overall goal of this research proposal is to design, engineer, and test in vivo a type I collagen-based endovascular template for the therapy of cerebral aneurysms. Cerebral aneurysms are present in at least 0.5-1.0% of the United States population, and aneurysm rupture remains an important cause of morbidity and mortality. Even in major referral centers, a significant number of aneurysms are not amenable to surgical repair. The device described in this proposal is specifically designed to act as a vascular template to support and guide vascular regeneration at the base of the aneurysm and to inhibit blood flow into the aneurysm sac, resulting in thrombosis of the aneurysm. A preliminary in vitro study was performed using the initial prototype developed by the principle investigator of this proposal. The results demonstrated that type I collagen may be used to construct a hemocompatible tubular template that produces a modest reduction in arterial luminal dimension and little change in flow. During phase I, we will examine the in vivo feasibility of the collagen template in a rabbit model, while in phase II we will extend the period of study in the rabbit model to evaluate the long term effects of the collagen template. The neurosurgical and interventional neuroradiology community is in serious need of a viable therapy for wide-neck aneurysms. If an acceptable template is developed, it is estimated that the yearly gross revenues from such a template would exceed at least $100 million. Furthermore, the work described in this proposal could be expanded to apply to a wide range of clinical applications, including percutaneous angioplasty, closure of arteriovenous fistulae, and billary, renal and esophageal procedures. If widely applied clinically, a collagen-based template could generate well over $1 billion per year worldwide. PROPOSED COMMERCIAL APPLICATIONS: See above abstract

本研究计划的总体目标是设计、制造和在体内测试一种基于I型胶原蛋白的血管内模板，用于治疗脑动脉瘤。美国人口中至少有0.5-1.0%的人患有脑动脉瘤，动脉瘤破裂仍然是发病率和死亡率的重要原因。即使在主要的转诊中心，也有相当数量的动脉瘤无法进行手术修复。本提案中描述的装置是专门设计用于作为血管模板来支持和引导动脉瘤底部的血管再生，并抑制血液流入动脉瘤囊，导致动脉瘤血栓形成。初步的体外研究使用由本提案的主要研究者开发的初始原型进行。结果表明，I型胶原可用于构建血液相容的小管模板，使动脉管腔尺寸适度减小，血流变化不大。在第一阶段，我们将在兔模型中检查胶原模板的体内可行性，而在第二阶段，我们将延长兔模型的研究时间，以评估胶原模板的长期效果。神经外科和介入神经放射学界迫切需要一种可行的治疗宽颈动脉瘤的方法。如果制定出一个可接受的模版，估计这种模版每年的总收入将至少超过1亿美元。此外，本提案中描述的工作可以扩展到广泛的临床应用，包括经皮血管成形术，动静脉瘘闭合，胆道，肾脏和食管手术。如果在临床上广泛应用，基于胶原蛋白的模板每年可以在全球范围内产生超过10亿美元的收入。建议的商业应用：见上述摘要