一种新型可降解食道支架的生物力学研究  

Biomechanical Study of New Biodegradable Esophageal Stent

作　　者：颜文涛 郁红漪 丁彪 郑忠伟 严航 林生力 周平红 YAN Wentao;YU Hongyi;DING Biao;ZHENG Zhongwei;YAN Hang;LIN Shengli;ZHOU Pinghong(Shanghai Institute of Medical Device Testing,Shanghai,201318;Shanghai Elitek Biosciences Co.Ltd.,Shanghai,200131;Center of Endoscopy,Zhongshan Hospital,Fudan University,Shanghai,200032)

机构地区：[1]上海市医疗器械检验研究院,上海市201318 [2]上海医立泰生物科技有限公司,上海市200131 [3]复旦大学附属中山医院内镜中心,上海市200032

出　　处：《中国医疗器械杂志》2022年第2期126-131,共6页Chinese Journal of Medical Instrumentation

基　　金：上海市科委科研计划项目(18441901102)。

摘　　要：可降解食道支架降解前后的径向支撑力是有效治疗食道狭窄的重要指标之一。该研究基于体外试验和有限元分析相结合的方法,研究并验证一种新型可降解食道支架在不同食道狭窄条件下的生物力学性能。在径向挤压工况下,支架端口最大应力为65.25 MPa,最大应变为1.98%;局部挤压和平行板挤压工况下应力应变峰值均出现在挤压区域和两端受压扩张区域,分别为48.68 MPa、46.40 MPa和0.49%、1.13%。未降解支架径向支撑力最大值为11.22 N,降解3个月和6个月后分别保持了97%和51%的最大径向支撑力。研究结果验证了新型可降解食道支架的径向支撑力的安全性和有效性,为临床治疗食道狭窄提供理论依据。The radial force of the degradable esophageal stent before and after degradation is one of the important indicators for effective treatment of esophageal stricture.Based on a combination of in vitro experiments and finite element analysis,this paper studies and verifies the biomechanical properties of a new type of degradable esophageal stent under different esophageal stricture conditions.Under radial extrusion conditions,the maximum stress at the port of the stent is 65.25 MPa,and the maximum strain is 1.98%;The peak values of stress and strain under local extrusion and plane extrusion conditions both appear in the extrusion area and the compression expansion area at both ends,which are respectively 48.68 MPa,46.40 MPa,0.49%,1.13%.The maximum radial force of the undegraded stent was 11.22 N,and 97% and 51% of the maximum radial force were maintained after 3 months and 6 months of degradation,respectively.The research results verify the safety and effectiveness of the radial force of the new degradable esophageal stent,and provide a theoretical basis for the clinical treatment of esophageal stricture.

关 键 词：食道支架 径向支撑力 生物可降解 有限元分析 

分 类 号：R318.01[医药卫生—生物医学工程]