北京生物医学工程

新型生物可吸收房间隔缺损封堵器的生物相容性研究

Biocompatibility study of a new type of biodegradable septal defect occluder

作者：谢兆丰王树水张智伟刘香东陈贤淼张贵张德元

单位： 广东省心血管病研究所，广东省华南结构性心脏病重点实验室，广东省医学科学院，广东省人民医院  (广州510100)

分类号：R318.08

出版年·卷·期（页码）：2016·35·6（582-587）

摘要：

目的评价自主研究的新型房间隔封堵器的生物相容性，为动物实验提供依据。方法封堵器框架由生物可吸收聚左旋乳酸（poly-L-lactic acid, PLLA）单丝网编织成型。通过对PLLA单丝进行体外细胞毒性测试、体外溶血测试、全身急性毒性测试、肌肉植入实验，评价新型房间隔封堵器的生物相容性。结果 PLLA房间隔缺损封堵器无体外细胞毒性，体外溶血率0.9%，无急性全身毒性反应。通过分析样品植入肌肉1个月、3个月和6个月后组织病理，观察样品与组织之间的反应，未发现明显的组织损伤和组织增生。结论生物可吸收PLLA房间隔封堵器的生物相容性良好，可进行下一步的动物实验研究。

Objective To design an atrial septal defect (ASD) occluder made of biodegradable poly-L-lactic acid (PLLA) and to evaluate its biocompatibility in vitro. Methods Bio-absorbable PLLA monofilament was used as occluder frame. Cytotoxicity test, acute toxicity test, hemolysis test and muscle implantation of PLLA monofilament were selected to evaluate the biocompatibility of the occluder. Results The PLLA monofilament had no cytotoxicity, no acute systemic toxicity and its hemolysis rate was 0.9% in vitro. No obvious tissue damage and tissue proliferation were observed at 1, 3 and 6 months after implantation of the samples. Conclusions The occluder made of bioabsorbable PLLA has good biocompatibility and can be selected for the next animal experimental study.

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