Shape Memory Polymer Embolic Foams for Treating Cerebrovascular Aneurysms

用于治疗脑血管动脉瘤的形状记忆聚合物栓塞泡沫

• 批准号: 9015786
• 负责人: DUNCAN J MAITLAND
• 金额: $ 88.17万
• 依托单位: TEXAS ENGINEERING EXPERIMENT STATION
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-03-01 至 2019-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9015786
• 关键词: Acute; Aneurysm; Animal Model; Animals; Blood; Blood Vessels; Blood coagulation; Cerebral Aneurysm; Cessation of life; Chronic; Cicatrix; Clinical; Clinical Trials; Coagulation Process; Connective Tissue; Data; Device Approval; Device Designs; Devices; Engineering; Exhibits; Family suidae; Filler; Healed; Health; Human; Implant; Incidental Findings; MRI Scans; Marketing; Memory; Metals; Modeling; Neurologic Dysfunctions; Oryctolagus cuniculus; Parents; Pathway interactions; Patients; Polymers; Preparation; Principal Investigator; Process; Production; Protocols documentation; Quality Control; Research; Risk; Route; Rupture; Ruptured Aneurysm; Safety; Shapes; Surgeon; System; Testing; Time; Translating; United States; Validation; Veins; Vertebral column; Work; X-Ray Computed Tomography; biomaterial compatibility; cerebrovascular; comparative; design; follow-up; healing; implantation; in vivo; manufacturing scale-up; meetings; neurovascular; polyurethane foam; prevent; programs; response; safety study; verification and validation

 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.

 描述（由申请人提供）：我们拟开发一种用于治疗脑血管动脉瘤的形状记忆聚合物（SMP）泡沫栓塞器械。SMP植入物优于当前临床替代品的上级之处在于，它们1）在整个动脉瘤体积中更快且更完全地急性凝血，以及2）通过形成胶原性瘢痕而慢性愈合。在美国，每年约有30，000人发生脑动脉瘤破裂，造成毁灭性后果。四分之三的患者会死亡或神经衰弱。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然发现，通常进行治疗以防止动脉瘤破裂，其具有>50%的严重神经功能障碍或死亡风险。目前的血管内治疗涉及通过动脉系统递送线圈以填充动脉瘤，平均需要5- 8个线圈来治疗单个动脉瘤。在30%的治疗动脉瘤中，弹簧圈移位或被压缩。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，因此也存在使其预期填充的动脉瘤破裂的风险。对弹簧圈的愈合反应是另一个主要缺陷：长期而言，动脉瘤的中心核心区域由松散的细胞结缔组织、碎片灶和凝血组成，而不是具有更稳定的纤维细胞组成。为了在本研究结束时向FDA申请IDE申请，提出了以下三个具体目标。具体目标1：工程、质量体系（QS）和制造。具体目标2：设计验证。具体目标3：设计确认。