两种国产室间隔缺损封堵器的生物相容性评价

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。

Biocompatibility Evaluation of Two Kinds of Homemade Ventricular Septal Defect Occluders

Objective:To evaluate the bioeompatibility and safety of two kinds of homemade ventricular septal defect occluders according to histological observation.Methods:Nine pigs were prepared for the experiment, a traumatic ventricular septal defect(VSD) animal model was established by surgical methods without extracorporeal circulation, and two kinds of homemade VSD occluders (cap type and no-cap type) were implanted directly during the surgical procedures. The animals were killed for histological observation at 1, 2, 3 months after occluder implantation.Results: Three pigs died of a lot of hemorrhage during operation. Occluders were implanted successfully in the other 6 pigs. Postmortem gross and microscopic examinations showed that all the right and left ventricular discs of the occluders were completely covered by a layer of smooth neointima. The inflammatory infiltrate around the occluders was found at 1 month, and disappeared and fibrosis formed at 3 months. Embolization in the lung, liver, spleen, kidney were not found in the 9 animals after device implantation. The compared experiment shows the rate of endothelization of the cap type occluder was slower than the no-cap type occluder.Conclusion:These suggest that the homemade VSD occluders has good bioeompatibility, and the bioeompatibility of the no-cap type occluder is better than that of the cap type occluder comparatively.