目的:观察国产室间隔缺损封堵器置入动物体内后的组织学反应,评价比较两种不同设计国产室间隔缺损封堵器的生物相容性和安全性。 方法:选用中华小型猪9只,非体外循环下通过外科方法建立创伤性肌部室间隔缺损动物模型,直视下经导管分别置入两种设计不同的室间隔缺损封堵器(有端头型和无端头型),术后1、2、3个月分别处死进行大体解剖、光镜和电镜观察。 结果:9只猪中3只因术中出血死亡,6只置入封堵器(无端头型和有端头型各3只)成功,均存活至各自的实验终点。大体标本显示各组封堵器表面均覆盖一层厚薄不等的、光滑的新生内膜组织,免疫组化染色证实其组织学来源于正常心内膜结构。封堵器置入处心肌组织早期有轻度炎症反应,3个月时消失并为纤维组织所代替。肺、肝、脾、肾脏等重要脏器均无血栓栓塞现象。对比研究发现,有端头型封堵器较无端头型封堵器内膜完全覆盖所需的时间稍长。 结论:两种国产室间隔缺损封堵器均有良好的生物相容性和安全性,相比之下无端头型封堵器生物相容性更佳。 OBJECTIVE: To observe the histological reaction of domestic ventricular septal defect occluder after being implanted into animals and to evaluate the biocompatibility and safety of two kinds of home-made ventricular septal defect occluders. Methods: Nine Chinese miniature pigs were selected to establish surgical models of traumatic muscular ventricular septal defect under cardiopulmonary bypass. Two kinds of ventricular septal defect occluders And without end), were sacrificed 1, 2, 3 months after surgery for gross anatomy, light and electron microscopy. Results: Three of the nine pigs died of intraoperative bleeding. Six of them were inserted into the occluder (three without tip and three with tip) and survived to their respective end points. The gross specimen showed that the occluder surface of each group was covered with a smooth neointimal tissue with a varying thickness, which was confirmed by immunohistochemical staining. The histology was derived from the normal endocardial structure. Occluder implantation myocardial tissue early mild inflammation, disappeared at 3 months and replaced by fibrous tissue. No significant thromboembolism occurred in vital organs such as lung, liver, spleen and kidneys. Comparative study found that the tip-type occluder than the end-type occluder completely covered the endometrium longer time. CONCLUSION: Both home-made ventricular septal defect occluders have good biocompatibility and safety. In contrast, end-less occluders have better biocompatibility.