论文摘要
目的 参照GB/T16886.4-2003/ISO10993:2002,GB/T16886.6-1997/ISO10993-6:1994标准,评价国产NiTi合金（nitinol）支架应用于人体血管内的可行性。本实验包括植入后局部反应实验、与血液相互作用试验、支架物理机械性能测定。目的是观察、评价材料植入活体组织内局部反应、血液或血液成分与器械间的相互作用所导致的对血液、器官、组织或器械的影响及支架的物理机械性能等是否可用于血管内治疗。方法:植入后局部反应实验选用日本大耳白兔10只,雌雄各半,在其脊柱一侧背部肌肉内植入人造血管:聚对苯二甲酸乙二酯纤维（polyethylene terephthalate,PET）膜材,另一侧植入医用硅橡胶（silicone rubber）做为对照,观察术后1周、4周、12周、26周、52周材料周围组织反应的情况;与血液相互作用试验:①选用绵羊10只,雌雄各半,体重20～27KG,在血管内植入NiTi合金支架,观察术后4周、6周、8周、12周、24周血管通畅情况,及其对血液成分、周围组织、器官的影响。②体外用NiTi合金支架放入盛有抗凝人血5ml的试管内,测定游离血红蛋白;体外测定NiTi支架物理机械性能。结果:PET膜材肌肉植入后,肉眼及组织病理检查结果符合国家规定的组织反应程度指标。NiTi合金支架在植入动物血管后,经DSA、MRI及组织病理检查证实血管通畅、无变形、移位,周围组织
论文目录
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