| 摘要: |
| 目的 设计和制作生物可吸收室间隔缺损(ventricular septal defect, VSD)封堵器,观察其体外降解特性并对其机械力学性能进行测试,为下一步经导管闭合VSD的动物实验打下基础。方法 采用可降解高分子聚合材料聚对二氧环己酮(polydioxanone,PDO)单丝、聚左旋乳酸(poly-L-lactic acid,PLA)无纺布和聚乙醇酸(polyglycolic acid,PGA)缝线制作生物可吸收VSD封堵器,在封堵器盘片上对称部位缝上金属钽颗粒为X线下显影标记,右侧盘片尾部设计一环形小襻供配套输送系统钳夹输送。体外测试可吸收VSD封堵器的相关力学性能,行体外降解试验,测定封堵器盘片支撑力和质量衰减情况。结果 可吸收VSD封堵器的机械力学性能包括压缩/弹性恢复性能、尾部环形襻极限拉力、左侧盘片支撑力皆满足经导管输送的封堵力学要求。体外降解实验显示,可吸收封堵器8周内结构和形状仍保持不变,12周时PDO丝出现断裂、崩解,盘片结构不完整。左侧盘片支撑力在体外降解2周和3周时支撑力比初始时增强(分别为初始支撑力的121.7%和107.8%),4周和6周时支撑力比初始时下降(分别降至88.6%和85.3%)。封堵器质量最初4周下降不到1%,6周以后质量明显下降。结论 用生物可吸收材料制作的VSD封堵器满足经导管植入体内的生物力学要求,可进行下一步的动物实验研究。 |
| 关键词: 可吸收性植入物 力学 封堵器 室间隔缺损 |
| DOI：10.3724/SP.J.1008.2013.00660 |
| 投稿时间：2013-03-20修订日期：2013-04-25 |
| 基金项目:国家自然科学基金(81170150),上海市科委医学引导基金(10411960200). |
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| In vitro degradation property and mechanical force test of a bioresorbable ventricular septal defect occluder |
| ZHU Yu-feng1,CHEN Wen-yao1,HUANG Xin-miao1,BAI Yuan1,WU Hong1,ZHANG Jin2,QIN Yong-wen1*,ZHAO Xian-xian1 |
(1. Department of Cardiovasology, Changhai Hospital, Second Military Medical University, Shanghai 200433, China
2. Research and Development Department, Shanghai Jinkui Medical Instruments CO.LTD, Shanghai 201103, China
*Corresponding author.) |
| Abstract: |
| Objective To design and prepare a ventricular septal defect (VSD) occluder with bioabsorbable materials and to evaluate its in vitro degradation and mechanical force. Methods A bioresorbable VSD occluder was made of polymeric materials polydioxanone (PDO) monofilament, poly-L-lactic acid (PLA) fabrics and polyglycolic acid(PGA) sutures. Tantalum particles were sewn on the symmetrical parts of the occluder disc as tracers for X-ray, and the end of the right side of the disc was designed with a circular loop for the matched delivery system to clamp and deliver. Mechanical property and the degradation of the occluder were tested in vitro, and the effect of degradation on the mechanical properties and weights of the samples was examined. Results The mechanical properties of the bioresorbable VSD occluder, including the compression/elastic recovery properties, ultimate intensity of circular loop in the right disc,and left disc support force, met the requirements for transcathetering closure of VSD. In vitro degradation experiment demonstrated that the structure and shape of the occluder remained unchanged within eight weeks; PDO wire fracture, disintegration, and incomplete disc structure were observed on the 12th week. The support force of the left disc increased to 121.7% and 107.8 % of the original ones at the 2nd week and the 3rd week, respectively; while the force decreased to 88.6% and 85.3% of the original ones at the 4th and the 6th week, respectively. The weight of the occluder decreased by less than 1% within the first 4 weeks, and significantly decreased 6 weeks later. Conclusion The VSD occluder made of biodegradable materials has qualified mechanical force for transcatheter implantation, and it can be used for future animal study. |
| Key words: absorbable implants mechanics occluder heart ventricular septal defects |
