Shape Memory Polymer Devices for Treating Stroke

用于治疗中风的形状记忆聚合物装置

• 批准号: 6737512
• 负责人: DUNCAN J MAITLAND
• 金额: $ 138.15万
• 依托单位: UNIVERSITY OF CALIF-LAWRNC LVRMR NAT LAB
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-05-03 至 2007-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6737512
• 关键词: acute disease /disorder; biomaterial compatibility; biomaterial development /preparation; biomedical equipment development; biotechnology; blood coagulation; blood vessel prosthesis; catheterization; fluoroscopy; laboratory rabbit; lasers; nervous system prosthesis; neuroregulation; polymers; stroke; stroke therapy; surface coating

DESCRIPTION (provided by applicant): We propose to develop interventional devices for treating stroke victims that currently have no therapeutic alternatives (.400,000/yr in the USA). The development and testing of two complementary devices is proposed: a mechanical clot extraction system and a neurovascular stent. The clot extraction system will address the current clinical need for an acute ischemic stroke treatment and the stent will address the chronic problem of stenosis and/or restenosis of the neurovasculature. Both of these devices utilize photomechanica' micro-actuators based on laser-activated shape memory polymer (SMP). SMP is a material that will have a significant impact on clinical medicine. SMP is a relatively new material that is similar to shape memory metals in its ability to actuate from an initial deformed shape into a second, pre-determined shape. Shape memory metals are currently very popular in medicine as a material for making vascular stents. SMP has advantages over shape memory metals for certain applications, including cost, higher recoverable strain levels, ease of manufacturing, better flexibility in navigating tortuous paths, and great versatility in fabricating extremely small, highly complex actuators. Potential applications of SMP include stents, stent release mechanisms, embolic coil release mechanisms, thrombus extraction devices, and many others. The underlying hypothesis of this research is that mechanical devices can be used to treat stroke victims where there is currently no clinical alternative. There are five known private companies that are currently pursuing this hypothesis for the acute ischemic device and an unknown but presumed large number of companies pursuing neurovascular stents. Members of the current proposal team originally developed one of the technologies that are in FDA trials for treating ischemic stroke, photo-acoustic emulsification of the thrombus. However, in our opinion, none of the current devices under FDA trials is as promising or as straightforward as the devices proposed. Further, we believe that the technology developed and published from the proposed studies will lead to many other medical applications that are far beyond the scope of one proposal and one team of investigators. The proposed research is a unique combination of biomaterials, lasers and optics, immunology/biocompatibility and clinical interventional neuroradiology. The long-term goal of this research is to deliver clinical prototype devices that can begin FDA clinical trials.

描述(由申请人提供)：我们建议发展干预性 用于治疗目前没有治疗方法的中风患者的设备 替代方案(在美国为.400,000/年)。两台车的研制与测试 提出了补充装置：一个机械血栓提取系统和一个 神经血管支架。血栓提取系统将解决目前的 急性缺血性卒中治疗的临床需求和支架将解决 神经血管系统狭窄和/或再狭窄的慢性问题。两者都有 这些设备中的一部分利用了光刻胶片的微执行器 激光激活形状记忆聚合物(SMP)。 SMP是一种将对临床医学产生重大影响的材料。SMP 是一种相对较新的材料，与形状记忆金属在其 能够从最初的变形形状变为第二个预先确定的形状 形状。形状记忆金属作为一种材料目前在医学上非常流行 用来做血管支架。与形状记忆金属相比，SMP在以下方面具有优势 某些应用，包括成本、更高的可恢复压力水平、易用性 制造，在曲折的道路上导航更好的灵活性，以及 在制造极小、高度复杂的执行器方面具有多功能性。潜力 SMP的应用包括支架、支架释放机构、栓塞圈 释放机构、血栓提取装置和许多其他装置。 这项研究的基本假设是，机械设备可以 用于治疗中风患者，目前没有临床替代方案。 目前有五家已知的私营公司正在努力实现这一目标 急性缺血装置的假说和一个未知但推定很大的 寻求神经血管支架的公司数量。现任成员 提案团队最初开发了FDA中的一项技术 光声乳化术治疗缺血性中风的临床研究 血栓。然而，在我们看来，目前在FDA试验中的设备中没有一种 就像提议的设备一样有希望或简单明了。此外，我们 相信从拟议的研究中开发和发布的技术 将导致许多其他医疗应用，远远超出 一份提案和一组调查人员。这项拟议的研究是一项独特的 生物材料、激光和光学、免疫学/生物兼容性和 临床介入神经放射学。 这项研究的长期目标是提供临床原型设备 可以开始FDA的临床试验。