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 治疗目前没有治疗性的中风受害者的设备 替代方案（美国为.400,000/年）。两个的开发和测试 提出了补充设备：机械凝块提取系统和A 神经血管支架。凝块提取系统将解决当前 急性缺血性中风治疗的临床需求，支架将解决 神经血管系统的狭窄和/或再狭窄的慢性问题。两个都 这些设备中利用Photomegonagic的微型演员基于 激光激活形状内存聚合物（SMP）。 SMP是一种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，类似于形状内存金属 从初始变形形状到第二个预先确定的能力 形状。形状记忆金属目前在医学中非常受欢迎作为一种材料 用于制作血管支架。 SMP比形状内存金属具有优势 某些应用程序，包括成本，更高的可回收应变水平，易于 制造业，在曲折路径中更好的灵活性，并且很棒 制造极其小，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，栓塞线圈 释放机制，血栓提取装置以及许多其他。 这项研究的基本假设是机械设备可以是 用于治疗目前没有临床选择的中风受害者。 目前有五家已知的私人公司正在追求这一点 急性缺血装置和未知但据推测的假设 追求神经血管支架的公司数量。当前成员 提案团队最初开发了FDA中的技术之一 治疗缺血性中风的试验，光听乳化的试验 血栓。但是，我们认为，在FDA试验下，当前的设备均未 与提出的设备一样有前途或直接。此外，我们 认为这项技术是从拟议的研究中开发和发表的 将导致许多其他医疗应用远远超出 一项建议和一个调查人员团队。拟议的研究是一项独特的 生物材料，激光器和光学，免疫学/生物相容性以及 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。