国产新型髂静脉支架的性能测试及动物实验研究  

The performance test and animal experiment of a new domestic iliac vein stent

作　　者：毛由军 李晓强[1] 王晓天[2] 冯海全[3] 李承龙[1] 庄浩 王婧[4] 殷音[4] 王永刚 Mao Youjun;Li Xiaoqiang;Wang Xiaotian;Feng Haiquan;Li Chenglong;Zhuang Hao;Wang Jing;Yin Yin;Wang Yonggang(Department of Vascular Surgery, The Second Affiliated Hospital of Soochow University, Suzhou 215004, China)

机构地区：[1]苏州大学附属第二医院血管外科,215004 [2]安徽省立医院血管外科 [3]内蒙古工业大学机械学院 [4]苏州大学动物实验中心 [5]苏州天鸿盛捷医疗器械有限公司

出　　处：《中华血管外科杂志》2018年第1期46-50,共5页Chinese Journal of Vascular Surgery

基　　金：江苏省科技项目临床医学科技专项（BL2014043）;苏州市卫计委市临床重点病种诊疗技术专项（LCZX201504）

摘　　要：目的 检测国产新型髂静脉支架的性能.方法 12只实验猪建立髂静脉狭窄模型,分别同侧植入新型髂静脉支架及对照支架,于术后即刻、30 d、60 d及90 d行髂静脉造影,观察支架展开情况,有无移位,支架通畅,有无血栓形成等;计算支架管腔丢失值及管腔丢失率,结合支架径向支撑力测试及有限元分析,评价新型髂静脉支架的性能.结果 通过支架径向支撑力测量及有限元分析,实验组支架的径向支撑性能优于对照组支架.动物实验中两组支架植入时均一次释放,各时间点造影检查未发现支架明显移位,支架通畅率100％;除对照组1例出现支架内少量陈旧性血栓外,其余支架均未发现;支架管腔直径两组术后均有不同程度的减小,但各检查时间点支架管腔丢失率比较差异无统计学意义（P〉0.05）.结论 国产新型髂静脉支架的径向支撑性能优良,前端＂花冠＂设计提高支架定位及释放的准确性,是一种较为理想的髂静脉支架.Objective To test the performance of a new domestic iliac vein stent. Methods Twelve experimental pigs were used to establish iliac vein stenosis model, and then the new iliac vein stent and the control stent were implanted ipsilaterally. We observed the stent deployment, stent shift, stent patency and stent thrombosis immediately after the stent implantation, at 30 days, 60 days and 90 days respectively. The loss of lumen and luminal loss ratio were calculated. The performance of new iliac vein stent was evaluated by the radial support force test and the finite element analysis. Results The radial support performance of the experimental group was better than that of the control group according to the radial support force measurement and the finite element analysis. In animal experiments, both groups were successfully released at one time. At the time of angiography, no stent shift was found, the stent patency rate is 100%. Except for one case in control group, there was a small amount of old thrombi in the stent, which was not found in other cases. Diameters of stents in two groups both reduced after surgery, but there was no significant difference in the loss rate of stent lumen at each time point（P〉0.05）. Conclusion The radial support performance of the new iliac vein stent is excellent, and the design of the top corolla improves the accuracy of the location and release of the stent. It is an ideal iliac vein stent.

关 键 词：支架 动物实验 髂静脉 

分 类 号：R54[医药卫生—心血管疾病]