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）：我们建议开发介入治疗 目前尚无治疗方法的用于治疗中风患者的设备 替代品（美国每年 0.400,000）。两个的开发和测试 提出了补充装置：机械凝块提取系统和 神经血管支架。凝块提取系统将解决当前的问题 急性缺血性中风治疗的临床需求，支架将解决 神经血管系统狭窄和/或再狭窄的慢性问题。两个都 这些设备利用基于光机械的微致动器 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。表面活性剂 是一种相对较新的材料，其特性与形状记忆金属相似 从初始变形形状驱动到第二个预定形状的能力 形状。形状记忆金属作为目前在医学上非常流行的材料 用于制造血管支架。 SMP 与形状记忆金属相比具有以下优势： 某些应用，包括成本、更高的可恢复应变水平、易于 制造，在曲折的道路上具有更好的灵活性，以及​​伟大的 制造极小、高度复杂的执行器的多功能性。潜在的 SMP 的应用包括支架、支架释放机制、栓塞弹簧圈 释放机制、血栓抽取装置等等。 这项研究的基本假设是机械装置可以 用于治疗目前没有临床替代方案的中风患者。 目前有五家知名私营公司正在追求这一目标 急性缺血装置的假设和未知但推测很大的 许多公司正在研发神经血管支架。现任成员 提案团队最初开发了 FDA 的一项技术 治疗缺血性中风的试验，光声乳化 血栓。然而，我们认为，目前 FDA 试验中的任何设备都没有 与所提出的设备一样有前途或简单。此外，我们 相信该技术是根据拟议的研究开发和发表的 将导致许多其他远远超出范围的医疗应用 一项提案和一组研究人员。拟议的研究是一项独特的研究 生物材料、激光和光学、免疫学/生物相容性和 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 临床试验。