目的 设计一种适用于肛瘘内口闭合手术的封堵器，研究封堵器的结构设计以及植入物与组织的相互作用，评估内口封堵性能。方法 对封堵器进行整体结构设计与样机制作；建立封堵有限元模型，研究封堵过程中组织的应力分布及损伤面积；搭建组织穿刺实验平台对仿真模型及结果进行验证；搭建拔出力实验平台对内口封堵效果进行评估。 结果 封堵过程中，进给机构的扭矩最大值为0.036N·m，组织的最大应力为19.75MPa，其损伤面积为1.35 cm2；有限元理论模型与实验结果基本吻合；拔出力的最大值达到5.11N。结论 封堵过程中的组织损伤面积满足肛瘘的微创治疗要求；本文设计的微创肛瘘封堵器可实现内口的有效封堵，有助于医生更加便捷、快速、有效地完成肛瘘的微创手术。
Objective To design a occluder suitable for anal fistula internal mouth closure surgery, study the structural design of the occluder and the interaction between implant and tissue, and evaluate the performance of internal mouth closure. Methods Design and model the overall structure of implant and occluder; The finite element model of plugging was established to study the stress distribution and damage area of tissues during plugging; Build a tissue puncture experimental platform to verify the simulation model and results; The pull-out force test platform was built to evaluate the sealing effect of the internal opening. Results During the plugging process, the maximum torque of the feeding mechanism is 0.036 N · m, the maximum stress of the tissue is 19.75 MPa, and the damage area is 1.35 cm2; The finite element model is basically consistent with the experimental results; The maximum pull-out force reaches 5.11N. Conclusions The area of tissue damage in the process of occlusion meets the requirements of minimally invasive treatment of anal fistula; The minimally invasive anal fistula occluder designed in this paper can effectively block the internal mouth , which is helpful for doctors to perform minimally invasive surgery for anal fistula more conveniently, quickly and effectively.