北京生物医学工程

新型生物可吸收房间隔缺损封堵器的体外性能测试

Test of a new type of biodegradable septal defect occluder in vitro

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：R318.04

出版年·卷·期（页码）：2016·35·5（521-526）

摘要：

目的对自制聚左旋乳酸（poly-L-lactic acid,PLLA）房间隔缺损封堵器进行材料及其相关性能的体外测试，为该封堵器的动物实验提供依据。方法采用生物可吸收PLLA单丝网编织成双盘状封堵器框架，两盘及腰部都缝有阻流膜，两盘各缝两个铂铱点作为标记。采用PLLA单丝拉伸性能测试、PLLA丝体外降解实验、PLLA封堵器主要尺寸测试、稳定性测试、入鞘力测试、栓头焊接强度测试、鞘管推送力测试及封堵器XA射线下可视性测试研究其体外性能。结果 PLLA房间隔缺损封堵器的体外性能测试均符合封堵器要求，在磷酸盐缓冲液(PBS)模拟人体内环境1月后，PLLA分子量下降至初始值的93.5%，2个月后下降至89.3%，至3个月时下降至78.9%。结论 PLLA房间隔封堵器体外性能测试良好，具有可降解性，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 mechanical properties and degradation in vitro. Methods The PLLA occluder is the first septal occluder with a biodegradable framework of PLLA, which is designed as “double-umbrella” framework. Two discs and waist are sewn with choked flow membrane while two discs are sewn with two platinum-iridium points respectively as a marker. The tensile properties of PLLA monofilament, PLLA degradation experiment, main dimensions of occluder, stability test, test of ability into the sheath, strength of the occluder, pushing force test of the occluder sheath, visibility test of PLLA occluder under X-rays are selected to test its properties in vitro. Results The properties of PLLA occluder in vitro meet the criterion of occluder. The molecular weight reduces to 93.5% of the initial value one month later, then decreases to 89.3% of the initial value 2 months later, and finally reaches 78.9% of the initial value 3 months later. Conclusions The PLLA occluder for ASD has qualified properties and degradation in vitro, which can be used for the future animal experiment.

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