一种可自动变形腔静脉滤器的体外评价实验  

A new self-convertible inferior vena cava filter: in vitro experimental evaluation

作　　者：高喜翔[1] 张建[1] 谷涌泉[1] 郭连瑞[1] 佟铸[1] 李立强[1] 李建新[1] 冯增国[2] Gao Xi-xiang;Zhang Jian;Gu Yong-quan;Guo Lian-rui;Tong Zhu;Li Li-qiang;Li Jian-xin;Feng Zeng-guo(Vascular Surgery Department,Xuanwu Hospital,Capital Medical University,Beijing 100053,China;School of Materials Science&Engineering,Beijing Institute of Technology,Beijing 100081,China)

机构地区：[1]首都医科大学宣武医院血管外科,北京市100053 [2]北京理工大学材料科学与工程学院,北京市100081

出　　处：《中国组织工程研究》2018年第10期1547-1552,共6页Chinese Journal of Tissue Engineering Research

基　　金：国家自然科学基金资助项目(30972944);科技部国家重点研发计划(2017YFC1104100);北京市医院管理局"登峰"人才培养计划(DFL20150801);首都卫生发展科研专项项目(首发2016-1-2012);北京市卫生系统高层次卫生技术人才培养计划学科骨干(2014-3-059);宣武医院"英才培养计划";北京市优秀人才培养青年骨干个人项目(2016000020124G108);北京市属医院科研培育计划(PX2018035);北京中医药科技发展资金项目(JJ2015-09);首都全科医学研究专项(17QK10)~~

摘　　要：背景:下腔静脉滤器是预防致命性肺栓塞的有效手段,现有滤器存在着一些不足,限制了其临床应用。目的:体外实验评价一种新型可自动变形腔静脉滤器的可变形性及捕栓效率。方法:将L-丙交酯、ε-己内酯进行融合聚合,作为滤器的可降解变形开关;采用医用不锈钢丝作为滤器的金属结构部分,将可降解变形开关与金属结构结合,制成可自动变形腔静脉滤器。在体外模型中(体外模型管路直径设置22,25,28 mm3种)植入15枚滤器(水平位和垂直位各植入1次),测量释放后倾斜角度;通过脂肪酶溶液加速滤器可变形开关降解,评价滤器的可变形性;向体外模型中注入血栓栓子,评价滤器的血栓捕获效率。结果与结论:(1)在3种不同直径管路中,无论垂直位还是水平位,所有滤器均成功植入,无滤器倾斜发生;(2)随着可降解开关的降解,15枚滤器均成功完成变形,变形过程中滤器结构未发生明显改变,无滤器倾斜和移位发生;滤器变形后,变形臂均完全回位,与管路内壁紧密接触;(3)不同管路直径和栓子大小及两种管路位置之间,可自动变形腔静脉滤器的栓子捕获效率差异均有显著性意义(P<0.001);在所有情况中,可自动变形腔静脉滤器的平均栓子捕获效率为82.5%;随着管路直径增大、栓子大小的减小,以及管路位置由垂直位变为水平位,可自动变形腔静脉滤器的栓子捕获率降低;(4)结果表明可自动变形滤器设计可行,栓子捕获效率高。BACKGROUND:Inferior vena cava filter is an effective way to prevent fatal pulmonary embolism.The existing filters have some shortcomings that limit the clinical application.OBJECTIVE:To evaluate the feasibility and capture efficiency of a new self-convertible inferior vena cava filter(SCF)in vitro.METHODS:The biodegradable switch was constructed of a copolymer ofε-caprolactone and L-lactide(75%/25%,PCLA75).The biodegradable switch bound together with the apices of the convertible struts to make the self-convertible filter.The deformability and capture efficiency of the filter were tested in an in-vitro flow model with three different diameters(22,25,28 mm).A total of 15 filters were implanted both in the vertical and horizontal positions,and the tilt angle of the filter was tested after release.To accelerate switch degradation,a lipase perfusate was injected into the flow model and refreshed every 8 hours until conversion.RESULTS AND CONCLUSION:(1)All the filters were successfully implanted without tilting,both in the vertical and horizontal positions in the three different diameter models.(2)All the 15 SCFs were converted successfully without tilting,structural damage,and displacement.(3)The capture efficiency of the SCF had significant difference between the different diameter of the models,the size of the embolus and the position of the two models(P<0.001).The mean capture efficiency was 82.5%,and the capture efficiency exhibited a downward trend with the increase of pipe diameter,the decrease of emboli size,and the position of pipeline changing from vertical to horizontal.All these results show that the SCF is feasible and highly efficient.

关 键 词：下腔静脉滤器 肺栓塞 生物可降解材料 生物材料 国家自然科学基金 腔静脉滤器 肺栓塞 组织工程 

分 类 号：R318[医药卫生—生物医学工程]