Shape Memory Polymer Embolic Foams for Treating Cerebrovascular Aneurysms

 描述(申请人提供)：我们建议开发一种用于治疗脑血管动脉瘤的形状记忆聚合物(SMP)泡沫栓塞器。SMP植入物优于目前的临床替代物，因为它们1)在整个动脉瘤体积内更快、更完全地迅速凝结，2)通过形成胶原性疤痕而慢性愈合。在美国，每年大约有30,000人发生脑动脉瘤破裂，造成毁灭性的后果。四分之三的患者要么会死亡，要么会变得神经衰弱。由于CT和MRI扫描的使用越来越多，许多未破裂的动脉瘤被确定为偶发发现，通常是为了防止动脉瘤破裂而进行治疗，而动脉瘤破裂有50%的严重神经功能障碍或死亡的风险。目前的血管内治疗包括通过动脉系统输送弹簧圈来填充动脉瘤，平均需要5-8个弹簧圈来治疗单个动脉瘤。在接受治疗的30%的动脉瘤中，弹簧圈移位或变得受压。这种压缩为血液重新进入动脉瘤打开了一条通道，导致动脉瘤再次膨胀。由于弹簧圈是金属弹簧，因此也存在破裂本应填充的动脉瘤的风险。对弹簧圈的愈合反应是另一个主要缺陷：长期以来，动脉瘤的中央核心区由疏松的细胞结缔组织、碎片灶和凝结的血液组成，而不是有更稳定的纤维细胞成分。为了在本研究结束前向FDA申请IDE应用程序，提出了以下三个具体目标。具体目标1：工程、质量体系和制造。具体目标2：设计验证。具体目标3：设计验证。

 DESCRIPTION (provided by applicant): We propose to develop a shape memory polymer (SMP) foam embolic device for treating cerebrovascular aneurysms. The SMP implants are superior to current clinical alternatives in that they 1) acutely clot faster and more completely throughout the aneurysm volume and 2) chronically heal by forming collagenous scars. Cerebral aneurysm rupture occurs in approximately 30,000 people per year in the United States with devastating consequences. Three-fourths of patients will either die or become neurologically debilitated. Given the increasing utilization of CT and MRI scanning, many unruptured aneurysms are being identified as incidental findings, and are commonly treated in order to prevent aneurysm rupture, which carries a >50% risk of severe neurologic dysfunction or death. Current endovascular treatment involves delivery of coils through the arterial system to fill the aneurysm, requiring on average 5- 8 coils to treat a single aneurysm. In 30% of treated aneurysms, the coils migrate or become compressed. This compaction opens a pathway for the blood to re-enter the aneurysm, causing the aneurysm to balloon once more. Coils, since they are metal springs, also present a risk of rupturing the aneurysm they are intended to fill. The healing response to coils is another major deficiency: Chronically the central core region of the aneurysm is composed of loose, cellular connective tissue, foci of debris, and clotted blood, rather than having a more stable fibrocellular composition. In order to apply to the FDA by the end of this study with an IDE application, the following three specific aims are proposed. Specific Aim 1: Engineering, Quality System (QS) and Manufacturing. Specific Aim 2: Design Verification. Specific Aim 3: Design Validation.