颅内编织密网支架输送性的体外模拟测试研究  

In-Vitro Simulation Testing of the Delivery Performance of Intracranial Nickel Titanium Braided Flow Diverting Stent

作　　者：张敬川 何宏宇 ZHANG Jing-chuan;HE Hong-yu(Shanghai Achieva Medical(Suzhou)Co.,Ltd.,Shanghai 200023;Shanghai Institute of Medical Device Testing,Shanghai 201318)

机构地区：[1]上海加奇生物科技苏州有限公司,上海200023 [2]上海市医疗器械检验研究院,上海201318

出　　处：《中国医疗器械信息》2025年第3期53-55,139,共4页China Medical Device Information

摘　　要：目的:依托测试集成平台,更精确地模拟体内血管测试条件,进行支架输送性能的测定方法试验研究。方法:模拟血液温度环境,测试水浴控制温度在(37±0.1)℃,采用模拟颅内解剖血管迂曲形态模型。在不同规格、不同速度、不同曲率的弯曲血管情况下,支架在模拟血管中进行输送。使用计算机数据采集与反馈系统,重复性试验验证,分别测试支架处在不同状态下的输送力高低。结果:发现大规格支架输送力远高于小规格支架;输送速度较慢的支架输送力低于输送速度快的支架;血管弯曲半径越小,输送力越高。结论:建立的体外模拟测试方法简便有效,可用于支架的产品性能确认、质量控制、以及临床手术一定的参考价值。Objective:To conduct experimental research on the measurement method of stent delivery performance by relying on a testing integration platform to more accurately simulate in vivo vascular testing conditions.Methods:Simulate the blood temperature environment,control the temperature of the water bath at(37±0.1)℃,and use a simulated intracranial anatomical vascular tortuosity model.Under different specifications,speeds,and curvatures of curved blood vessels,stents are delivered in simulated blood vessels.Using a computer data acquisition and feedback system,repeated experiments were conducted to verify the pushing force of the bracket in different states.Results:It was found that the pushing force of large-sized stents was much higher than that of small-sized stents;Stents with slower delivering speeds have lower pushing forces than those with faster delivering speeds;The smaller the radius of vascular curvature,the higher the pushing force.Conclusion:The established in vitro simulation testing method is simple and effective,and can be used for product performance confirmation,quality control,and clinical reference value of stents.

关 键 词：镍钛编织支架 颅内 输送性 输送力 模拟血管 

分 类 号：R319[医药卫生—基础医学]