摘要目的 对表面磁性膜血管内支架进行生物相容性研究,为该支架的临床应用提供实验依据.方法 通过溶血实验、动态凝血时间实验、急性全身毒性实验、皮内刺激实验、细胞毒性实验、热源实验、过敏实验、体内植入实验综合评价表面磁性膜血管内支架的生物相容性.结果 表面磁性膜血管内支架无溶血反应及凝血功能的改变,无急性全身毒性反应,无热源反应,支架材料中不存在致敏性物质;支架材料动物体内植入在初期有轻度的炎性反应,12周后炎性反应基本消失,未见炎性细胞浸润积聚现象.结论 表面磁性膜血管内支架具有良好的生物相容性,其应用于临床具有可行性和安全性.

abstractsObjective To investigate the biocompatibility and biological safety of surface magnetic film 316L Medical Stainless Steel Stent in vivo so as to provide experimental reference for clinical application.Methods Acute systemic toxicity test,intracutaneous stimulation test,hemolysis test,cytotoxicity test,pyrogen test,sensitivity test and muscle embedding test were performed in order to evaluating the biocompatibility and biological safety of surface magnetic film 316L Medical Stainless Steel Stent.Results There was no potential allergic substance in magnetic Stent,and no hemolytic reaction,acute systemic toxicity effect or pyrogen reaction was observed.Mild inflammatory reaction was seen in the surrounding tissues in the early implantation stage,which completely disappeared after 12 weeks.Macrophage aggregation was not noted.Conclusion surface magnetic film 316L Medical Stainless Steel Stent has fine biocompatibility,which is feasible and safe for clinical application.