房间隔缺损闭合器组织相容性研究

Studies of the Histocompatibility Evaluation on Atrial Septal Defect Closer

目的:采用GB/T16175-1997和ISO10993-6:2007标准中植入后局部反应试验的结果判定方法,评价房间隔缺损闭合器植入体内后的组织相容性,探讨两种方法在组织相容性评价中的作用。方法:采用试验动物家兔皮下植入试验,将试验样品植入家兔背部皮下组织,分别于植入后1周、4周和12周后处死动物,取材,常规制片,HE染色,组织学观察采用炎症和纤维囊腔分级法及半定量记分法。结果:样品皮下植入后随着时间的延长,其周围组织的反应程度呈加重趋势。植入后12周,组织学反应未达到稳态。两种方法的组织学观察结果是一致的。结论:两种方法在组织学评价中均有其局限性,实际中可将两种方法结合来评价医疗器械的组织相容性,建议继续观察该样品植入后26周的局部反应,以减少临床使用的风险。

Objective： To investigate the methods of histocompatibility evaluation on atrial septal defect closer. Methods： The rabbit implantation test in subcutaneous tissue was used for assessing the biological response of subcutaneous tissue to the implanted specimen. The specimens of the test materials were implanted into the rabbit paravertebral subcutaneous tissue. At 1, 4, 12 week after implantation, the animals were euthanized,and excised the subcutaneous tissueroutine prepared histological section and HE stain. Histocompatibility evaluation was done by the grading system for extent of fibrous capsule, inflammation and semiquantitative scoring system. Results At 1 week, 4 week and 12 week after implantation, the tissue reaction around the specimen revealed aggravated tendency Furthermore, at the termination, the local reaction was not reaching the steady state, the histology observation was coincident by evaluation of two methods. Conclusion： There were some limitations on the two methods of histocompatibility evaluation, we can combine the methods to evaluate the tissue reaction, and suggest that to observe the local reaction in 26 weeks after implantation in order to reduce the clinical risk.