CAJ | 학술논문

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100 000 U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l、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＞5 mm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.
목적 대채용좌선취유산(PLLA)제비생물가강해강정맥려기(BVCF)진행연구,병평고기궤계역학성능、가수송성능、포획혈전성능급기생물상용성.방법 이용삼유설계연건설계BVCF외형,채용분자량위100 000 U적PLLA제작BVCF,통과체외실험,대기주요성능진행측시.채용중화소형저12지,수궤분위4조(매조3지),제1～3조위실험조,제4조위대조조.장9매BVCF치입제1～3조실험소형저하강정맥내,1주후대소유소형저행혈전주입실험.매조적3지소형저하강정맥분별주입2、5화8조혈전.주입혈전후l、6、12주행영상검사,관찰려기정황급소형저폐동맥전새정황.매차영상검사후,희생1조실험조동물행병리검사.결과 제비출일충대중심선형적가강해려기,통과체외실험측시려기경향지탱력1.6N,능구포획직경＞5 mm적전자,역우석방.통과동물실험증실해려기능구포획주입적치명성전자,9지실험조소형저균존활,기중2지전자주입과정중출현경도호흡、심솔가쾌；대조조소형저주입혈전후불동정도지출현호흡빈솔가쾌、기촉등증상,주입8조혈전적소형저,재혈전주입후당천사망.술후영상급병리검사현시,실험조출현증상적소형저발생주위성폐동맥전새,대조조사망소형저발생중앙성폐동맥전새.현미경하현시려기치입술후1주,BVCF측지부분피내막복개；6주후완전피내막복개,혈관벽결구정상,미견명현염성세포침윤；술후12주BVCF측지내막정황무명현변화,려기측지부분강해.결론 BVCF구유량호적궤계강도화가수송성능,대치명성대전자유교고적포획솔,병구유량호적생물상용성,단기강해성능상수진일보연구.
Objective To investigate the preparation of biodegradable vena cava filter(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 histopathological 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 pig which 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 pulmona-y embolism.Histological findings showed that the intima covered the BVCF lateral branch partly after one week,and thoroughly after six weeks.The vessel wall structure remained normal and no signs of the obvious inflammatory cells infiltration were detected.Twelve weeks after the implantation,the vessel wall structure was normal,and the lumen was unobstructed,and the collateral of the filter was partly degradated.Conclusions The BVCF has the advantage of good mechanical strength and good biocompatibility.It is easy to release and can capture the lethal thrombus,but its degradation performance remains to be studied.