国产室间隔缺损封堵器生物相容性的试验研究

Study on biocompatibility of homemade ventricular septal defect occluder

目的观察国产室间隔缺损封堵器植入动物体内的组织学反应,研究其生物相容性。方法选7只实验用犬及3只小型猪非体外循环下通过外科方法建立创伤性室间隔缺损动物模型,直视下经导管植入CardiaCure-ZH心血管异常通道闭合器(北京科迪凯尔医学技术有限公司)。分别于术后1、3、6个月处死试验动物取封堵器标本行大体肉眼观察、光镜及扫描电镜检查。结果1只实验犬因出血于术中死亡,另1只实验犬因术中气栓瘫痪,1周后死亡,余8只植入封堵器成功,均存活至各自试验终点。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;光镜检查显示封堵器网塞上心脏内皮细胞爬生完整,邻近组织未见炎性反应及异物巨细胞聚集,周围心肌未见坏死。扫描电镜观察显示封堵器表面内皮细胞完全覆盖,细胞排列紧密,但封堵器的金属端头未能被心脏内皮细胞完全覆盖。结论实验结果表明,CardiaCure-ZH心血管异常通道闭合器具有良好的生物相容性。

Objective To evaluate the biocompatibility of homemade occluder （CardiaCare -ZH）. Methods 7 dogs and 3 pigs were prepared for the experiment,a traumatic ventricular septal defect （VCD） animal model was established by surgical methods without exreacorporporeal. Homemade VSD occluder was implanted directly during the surgical operation,and experimental animals were killed for histological 9bservation at 1,3 and 6 months respectively after occluder implantation. Results One dog was dead resulted from a lot of hemorrhage during operation, another one was dead one week later resulted from air embolism and the other 8 animals were implanted occluder successfully. Postmortem gross showed surface of wire mesh was covered with a layer of smooth neoendocardium. Sponge inside of device were substituted for fibrosis. Histopathological examination revealed complete endothelialization at the site of occluder implantation and a variable degree of neointimal proliferation. There was no inflammatory reaction and large collection of foreign-body giant cells, no medial necrosis. Scanning electron microscope examination revealed complete endothelialization at the site of occluder, and the endothelialization cells were arranged orderliness and orderliness,but the occluder＇ s cap was endothelialized incompletely. Conclusion The CardiaCare＇ -ZH occluder has good biocompatibility.