生物可降解腔静脉滤器的制备及其性能研究  

The preparation of biodegradable vena cava filter and the study of its properties

作　　者：张肖[1] 肖越勇[1] 杨杰[1] 马旭阳[1] 刘士榕[1] 任超[1] 王小平[1] 

机构地区：[1]解放军总医院放射诊断科,北京100853

出　　处：《中华放射学杂志》2012年第11期1023-1027,共5页Chinese Journal of Radiology

基　　金：国家自然科学基金资助项目（30970815）

摘　　要：目的对采用左旋聚乳酸（PLLA）制备生物可降解腔静脉滤器（BVCF）进行研究，并评估其机械力学性能、可输送性能、捕获血栓性能及其生物相容性。方法利用三维设计软件设计BVCF外形，采用分子量为100000U的PLLA制作BVCF，通过体外实验，对其主要性能进行测试。采用中华小型猪12只，随机分为4组（每组3只），第1～3组为实验组，第4组为对照组。将9枚BVCF置入第1～3组实验小型猪下腔静脉内，1周后对所有小型猪行血栓注入实验。每组的3只小型猪下腔静脉分别注入2、5和8条血栓。注入血栓后1、6、12周行影像检查，观察滤器情况及小型猪肺动脉栓塞情况。每次影像检查后，牺牲1组实验组动物行病理检查。结果制备出一种带中心线型的可降解滤器，通过体外实验测试滤器径向支撑力1．6N，能够捕获直径〉5mm的栓子，易于释放。通过动物实验证实该滤器能够捕获注入的致命性栓子，9只实验组小型猪均存活，其中2只栓子注入过程中出现轻度呼吸、心率加快；对照组小型猪注入血栓后不同程度地出现呼吸频率加快、气促等症状，注入8条血栓的小型猪，在血栓注入后当天死亡。术后影像及病理检查显示，实验组出现症状的小型猪发生周围性肺动脉栓塞，对照组死亡小型猪发生中央性肺动脉栓塞。显微镜下显示滤器置入术后1周，BVCF侧支部分被内膜覆盖；6周后完全被内膜覆盖，血管壁结构正常，未见明显炎性细胞浸润；术后12周BVCF侧支内膜情况无明显变化，滤器侧支部分降解。结论BVCF具有良好的机械强度和可输送性能，对致命性大栓子有较高的捕获率，并具有良好的生物相容性，但其降解性能尚需进一步研究。Objective To investigate the preparation of biodegradable vena cava fiher（BVCF） with poly-l-lactic acid （ PLLA）, and to evaluate its mechanical properties, delivery performance, the ability of capturing thrombus and the degradation property. Methods Three-dimensional design software was used to design the shape of BVCF. The BVCF was prepared by using PLLA with molecular weight of 100 000 unit. Twelve minipigs were used to test the feasibility of this BVCF. They were randomly divided into four groups. At first the BVCFs were placed into the inferior vena cava of pigs in three experimental groups. The fourth group was used as a blank control group. The thrombi were injected into all pigs after 1 week, and CT examinations were performed at different time points to observe the filter locations and pulmonary artery. The animals were sacrificed according to a fixed time table for histopathologieal assessment. Results The BVCF was successfully designed and produced, which could expand by stretching the center-thread. In vitro test results showed the radial force of BVCF was approximately 1.6 N and could capture the thrombus more than 5 mm in diameter, and it was easy to release. Through the animal experiment confirmed that the filter could capture the lethal thrombus and all 9 pigs of experimental groups were survived, two of those had the symptoms of respiratory frequency and heartbeat accelerated slightly in the operation. In control group, the symptoms such as accelerate of respiratory rate, shortness of breath were observed in varying degree. The pigwhich was injected with 8 strips of thrombus died in the same day after surgery. Postoperative CT and pathological examinations showed that 2 pigs in the experimental group developed peripheral pulmonary embolism, while the dead pig in the control group developed central pulmonary embolism. Histological findings showed that the intima covered the B^CF lateral branch partly after one week, and thoroughly after six weeks. The vessel wall structure remained normal a

关 键 词：生物相容性材料 腔静脉滤器 抗压强度 生物降解 

分 类 号：R318.08[医药卫生—生物医学工程]