目的：评价国产房间隔缺损(ASD)堵塞装置的生物相容性。方法：选用乳猪6头(平均体重7.5 kg)，利用穿刺针和 Rashkind球囊房隔造口术，建立大小不等ASD动物模型，选择适当大小的国产房间隔缺损堵塞装置进行封堵，术后1个月、3个月和6个月分别将小猪处死(每次2只)，通过肉眼观和光镜检查。结果：肉眼观：所有装置表面均没有发现赘生物、血栓形成、支架断裂及被腐蚀,术后3月装置大部分已被组织包埋，术后6月完全被包埋。光镜检查：术后1月，装置表面被胶原纤维和散在内皮细胞所覆盖，大量炎症细胞浸润，装置边缘有小灶性炎症细胞浸润；术后3月，装置表面被大量成熟胶原纤维覆盖，局部见上皮样细胞，炎症细胞较1个月时明显减少，装置边缘心肌细胞浸入；术后6月，装置表面被心内膜和纤维组织所覆盖，炎症反应明显消散，但仍有少量慢性炎症细胞存在，纤维组织内有新生的血管、淋巴管长入，装置内被增生的纤维组织填塞伴胶原化。结论：国产房间隔缺损装置具有良好的生物相容性。

OBJECTIVE: To evaluate the biocompatibility of the home made atrial septal defect (ASD) occluder device. METHODS: ASD animal models with different size defects were established by the brockenborough needle followed by Rashkind balloon atrial septostomy. Occluder devices were implanted in six piglets (mean weight 7.5 kg ). Two pigs were sacrificed after 1 month, 3 months and 6 months of implantation respectively. Macroscopic and microscopic assessments were done on the explanted devices. RESULTS: Macroscopic examination showed no excrescence, thrombus formation, arm fractures and corrosion. The devices were mostly embedded in soft tissues three months after implantation and embedded completely by 6 months. Microscopic examination showed apparent inflammatory infiltration inside and around the devices; the devices were covered with collagen fibrin and diffuse endothelial cells 1 month after implantation. By 3 months after implantation, fibrosis was formed while the inflammatory reaction decreased gradually; myocardial cells ingrowed at the edge of the devices; endothelium like cells could be found on the surface of the devices. By 6 months after implantation, neovascularization and lymphatic vessel ingrowth were noted; the inflammatory reaction diminished with only a few chronic inflammatory cells; the devices were completely covered by endothelium and fibrous tissues. CONCLUSIONS: The home made ASD occluder device has a good biocompatibility.