胰岛素笔用针头性能的有限元分析与实验研究

Finite element analysis and experimental study of the performance of insulin pen needles

目的对比分析不同型号胰岛素笔用针头切面设计及尺寸与其穿刺力、流速、按压力之间的关系。方法分别建立人体皮肤组织和针头模型,并进行针头穿刺的有限元模拟分析。使用测试平台检测25种具有不同几何参数针头的穿刺力、推药压力、流速等参数,分析几何参数对针头性能的影响。结果针头穿刺力与其切面设计密切相关。与三切面针头相比,五切面针头增加了二级倾角和壁角,其针头与组织接触面积更大,接触角度的变化更平缓,降低了针头穿刺力。针头外径越小其穿透力越小;内径越大,药液流速越大、推药压力越小、注射精度越高。结论五切面、超薄壁或极薄壁针头具有更优异的性能。可在保证针头强度的基础上,通过优化针头几何参数,减小穿刺力。本研究结果可为胰岛素笔用针头的设计提供理论基础和实验依据。

Objective To compare and analyze the relationship between geometric parameters of the needle of different insulin pens and their puncture force,flow rate,and pressing force.Methods The human skin tissue model and needle model were established,and the finite element simulation analysis of needle puncture was performed.Using a test platform,25 kinds of needles with different geometric parameters were tested for the puncture force,pushing pressure,flow rate and other parameters.The influence of geometric parameters on the performance of the needles were analyzed.Results The puncture force of the needle was closely related to its section design.Compared with the three-section needle,the five-section needle increases the secondary inclination angle and the condyle angle,increases the contact area between the needle and the tissue,and make the change of the contact angle more smoothly,which reduce the needle penetration force.The smaller the outer diameter of the needle,the smaller the penetrating power.The larger the inner diameter of the needle,the greater the fluid flow rate,the smaller the pushing pressure,and the higher the injection accuracy.Conclusions Five-section,ultra-thin-walled or ultra-thin-walled needles have more excellent performance.On the basis of ensuring the strength of the needle,the needle’s geometry can be optimized to reduce the puncture force.The results of this study can provide theoretical basis and experimental basis for the design of needles for insulin pens.