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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 observe the histological reaction of domestic ventricular septal defect occluder implanted in animals and study its biocompatibility. Methods Seven experimental dogs and three miniature pigs were randomly divided into three groups: cardiaCure-ZH cardiovascular abnormality channel closure device Medical Technology Co., Ltd.). The animals were sacrificed at 1, 3, and 6 months after operation respectively. Gross occlusion specimens were examined by naked eyes, light microscopy and scanning electron microscopy. Results One experimental dog died of hemorrhage during operation. The other experimental dog died of paralysis after one week and died after one week. The remaining eight rats were successfully implanted into the occluder and survived until the end of their respective trials. The gross specimen showed that the surface of the occluder showed smooth and smooth neointimal hyperplasia. The sponge core structure in the mesh plug was intact and fused with hard connective tissue. Light microscopy showed that the occluder mesh plug was located on the heart endothelium Creeping cells intact, no inflammatory reaction in adjacent tissues and foreign body giant cells gathered around the myocardium did not necrosis. Scanning electron microscopy showed that the endothelial cells on the occluder surface were completely covered and the cells arranged closely, but the metal tip of the occluder could not be completely covered by the heart endothelial cells. Conclusion The experimental results show that CardiaCure-ZH cardiovascular abnormal channel closure device has good biocompatibility.