Shape Memory Polymer Devices for Treating Stroke

描述（由申请人提供）：我们建议开发干预性 用于治疗中风患者的装置， 替代品（美国为40万/年）。开发和测试两个 提出了一种互补装置：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 急性缺血性卒中治疗的临床需求，支架将解决 神经脉管系统的狭窄和/或再狭窄的慢性问题。两 这些设备利用光机械的微致动器， 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。SMP 是一种相对较新的材料，在其 从初始变形形状致动成第二预定形状的能力 形状形状记忆金属作为一种材料目前在医学上非常受欢迎 用于制造血管支架。SMP具有优于形状记忆金属的优点， 某些应用，包括成本，更高的可恢复应变水平， 制造业，更好的灵活性，在导航曲折的道路， 在制造极小的、高度复杂的致动器方面的多功能性。潜在 SMP的应用包括支架、支架释放机构、栓塞线圈 释放机构、血栓提取装置和许多其它装置。 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。 目前有五家已知的私人公司正在追求这一点 急性缺血器械的假设和未知但推测的大 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， 治疗缺血性中风的试验， 血栓然而，在我们看来，目前在FDA试验中的设备 和所提出的设备一样有前途或简单。我们还 我相信，从拟议的研究中开发和发表的技术， 将导致许多其他的医疗应用，远远超出了范围， 一份提案和一组调查人员这项研究是一项独特的 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的临床试验。

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.