摘要
该文利用有限元模拟分析方法,对一款国产镍钛合金材料卵圆孔未闭封堵器的设计结构进行了初步应力/应变分析。分析中对3个型号规格国产卵圆孔未闭封堵器进行实体结构建模,参考检验标准YY/T 1553—2017中疲劳性能的测试方法,对模型施加初始的安装变形,接着对样品施加2 mm的疲劳位移量,使模型产生疲劳变形,通过应变仿真分析得到各型号规格封堵器的疲劳安全系数。结果表明,3个型号规格的卵圆孔未闭封堵器的最小疲劳安全系数分别为2.09、2.35和2.06,均满足疲劳安全系数大于1的设计要求。其中,1818和3030型号规格卵圆孔未闭封堵器的最小疲劳安全系数较为接近,且均低于1825型号规格,因此,建议对1818和3030型号规格卵圆孔未闭封堵器均进行实物疲劳试验,以进一步验证产品的疲劳安全性能。
In this paper,a preliminary stress/strain analysis of the design structure of a nickel-titanium alloy patent foramen ovale occluder is conducted with the finite element simulation analysis method.In the analysis,solid structure modeling is carried out on three different specifications of domestic patent foramen ovale occluders.Referring to the test method of fatigue performance in inspection standard YY/T 1553—2017,an initial installation deformation is applied to the model,and then the fatigue displacement of 2 mm is applied to the sample to make the model fatigue deformation.The fatigue safety factors of each type of occluder are obtained by strain simulation analysis.The results indicate that the minimum fatigue safety factors of the three specifications of domestic patent foramen ovale occluders are 2.09,2.35 and 2.06 respectively,which all meet the design of fatigue safety factor greater than 1.Among them,1818 and 3030 specifications of patent foramen ovale occluders have close values in minimum fatigue safety factors,and both are lower than that of 1825 model.Therefore,it is recommended to carry out physical fatigue tests on both 1818 and 3030 specifications to further verify the fatigue performance of the products.
作者
沈娟
刘卫
SHEN Juan;LIU Wei(Suzhou Yuwen Testing Technology Co.,Ltd.,Suzhou,215143)
出处
《中国医疗器械杂志》
2025年第2期119-124,共6页
Chinese Journal of Medical Instrumentation
关键词
卵圆孔未闭封堵器
镍钛合金
应力/应变分析
疲劳安全系数
patent foramen ovale(PFO)occluder
nickel-titanium alloy
stress/strain analysis
fatigue safety factor
