心血管异常通道闭合器生物相容性初步实验探究.docVIP

心血管异常通道闭合器生物相容性初步实验探究 　 作者：刘加立 郑宏 蒋世良 刘明 孟亮 王红月 【摘要】 目的 研究国产心血管异常通道闭合器的生物相容性。方法 10只正常实验用犬的髂动脉及肺动脉内置入CardiaCureTM－PDA型闭合器共22枚(北京科迪凯尔医学技术有限公司生产)，犬髂动脉10枚，肺动脉12枚。术后10、30、45、60min及1个月行血管造影，3、6、12个月行组织学检查。结果 髂动脉组，封堵10min后造影示完全堵闭8枚，另2枚于封堵后 30min完全堵闭；肺动脉组，封堵后10、30、45、60min及1个月造影示完全堵闭分别为2、3、2、2、3枚，3～12个月大体标本显示闭合器表面均见厚薄不等的、光滑的新生内膜爬生，网塞内的海绵内芯结构完整并与坚硬的结缔组织融合；光镜及电镜检查显示闭合器网塞上血管内皮细胞爬生完整，邻近组织未见炎症反应及异物巨细胞聚集，中膜未见坏死。结论 初步实验结果表明，CardiaCureTM－PDA闭合器具有良好的生物相容性。 【关键词】 通道闭合器 生物相容性 实验研究 【Abstract】 Objective To evaluate the biocompatibility of homemade occluder(CardiaCureTM－PDA ).Methods 22 occluders were successfully implanted into iliac artery (n=10) and pulmonary artery (n=12) in 10 experimental dogs. Vessel angiography was performed post implantation after 10，30，45，60 minutes and 1 month respectively.In addition，all experimental animals were sacrificed for histological examination at 1，3，6，12 months respectively after occluders implantation. Results Iliac artery angiography showed complete occlusion after 10 minutes (n=8)，30 minutes (n=2).Pulmoanry artery angiography showed complete occlusion after 10 minutes (n=2)，30 minutes (n=3) after 45 minutes (n=2)，60 minutes (n=2) and 1 month (n=3) respectively. Gross specimen showed surface of wire mesh were covered with a layer of smooth neoendocardium. Sponge inside of device were substituted for fibrosis. 3 months later，scanning electron of microscope and histopathologic examination revealed complete endothelialization at the site of occluder implantation and a variable degree of neointimal proliferation. There were no inflammatory reaction and large collection of foreign-body giant cells，no medial necrosis. Conclusion Preliminary study demonstrates that CardiaCureTM－PDA have no serious local vascular tissue reaction and have good biocompatibility. 【Key words】 occluder(CardiaCureTM－PDA) biocompatibility experimental study 目前，房室间隔缺损封堵术及异常血管封堵术的器材多依赖进口，且价格昂贵，一定程度上制约了国内先心病介入治疗工作的发展。北京科迪凯尔医学技术有限公司研制生产的具有自主知识产权的心血管异常通道闭合器是一种从材料到制造均完全国产化的