仿生人工肛门括约肌系统生物相容性及便意感知实验研究  

Experimental study on biocompatibility and the fecal intention of a bionic artificial anal sphincter system

作　　者：丁紫凡 颜国正[1] 姜萍萍[1] 姚盛健 华芳芳 周泽润 DING Zifan;YAN Guozheng;JIANG Pingping;YAO Shengjian;HUA Fangfang;ZHOU Zerun(School of Electronic Information and Electrical Engineering&Institute of Medical Robotics,Shanghai Jiao Tong University,shanghai 200240)

机构地区：[1]上海交通大学电子信息与电气工程学院,上海200240

出　　处：《北京生物医学工程》2021年第5期461-470,共10页Beijing Biomedical Engineering

基　　金：国家自然科学基金(61673271、81971767);上海市科技支撑(19441910420、19441913800、19142203800);上海交通大学医疗机器人研究院项目(IMR2018KY05)资助。

摘　　要：目的针对人工肛门括约肌(artificial anal sphincter,AAS)长期植入活体后出现的生物相容性不佳、缺乏便意感知能力和血供安全性问题,提出一种仿生人工肛门括约肌系统(bionic artificial anal sphincter,BAAS)并进行实验评估。方法首先建立仿生人工肛门括约肌系统,系统采用封闭连杆式“三环”机构作为括约肌假体,外覆一体化医用硅橡胶薄膜以增强生物相容性,环臂嵌入10路压力传感模块,并采用经皮无线能量传输和无线通信实现体内外系统能量供给与信息交互。然后进行体外实验,以评估括约肌假体的控便能力与血供安全性,并创新地利用压力向量相似度作为便意判断的新标准建立便意智能感知模型。最后进行动物实验,对BAAS系统整体植入效果、生物相容性、控便及便意感知能力等进行观察和评估。结果体外实验表明,括约肌假体对肠道内容物的蓄控效果满足便意阈值需求,且最大夹持压力在肠道血供安全性范围内,满足控便和血供安全性要求。动物实验表明括约肌假体具有良好的密封性和生物相容性,验证了便意智能感知模型的可靠性,体内便意预警准确率最高可达80%。结论BAAS系统可以模拟肛门括约肌的功能,作为治疗重度肛门失禁的方法。Objective Aiming at the problems of poor biocompatibility,lack of rectal perception as well as blood supply safety after long-term implantation of the artificial anal sphincter(AAS)into a living body,a bionic artificial anal sphincter system(BAAS)is proposed and evaluated by experiments.Methods First,we establish a BAAS system.The system uses a closed link type“three rings”mechanism as a sphincter prosthesis,which is covered with an integrated medical silicone rubber film and embedded with ten pressure sensor modules,and uses percutaneous wireless energy transmission and wireless communication to achieve energy supply and information interaction between the internal and external systems.Then vitro experiments are conducted to evaluate the feces control ability and the blood supply safety of the sphincter prosthesis,and we innovatively use the pressure vector similarity as a new criterion for determining stool intention to establish a stool intention intelligent perception model.Finally,animal experiments are carried out to observe and evaluate the overall implantation effect,biocompatibility,feces control and the feces perception ability of the BAAS system.Results The in-vitro experiment shows that the control effect of the sphincter prosthesis on the intestinal contents meets the requirements of the bowel intention threshold,and the maximum clamping pressure is within the safety range of the intestinal blood supply,meeting the requirements for bowel control and blood supply safety.Animal experiments have proved that the sphincter prosthesis has good leakproofness and biocompatibility,and at the same time,it has verified the reliability of the rectal perception model as the accuracy of the warning of the defecation is up to 80%.Conclusions The new BAAS system can simulate the function of the anal sphincter and can be used as a method of treating severe anal incontinence.

关 键 词：人工肛门括约肌 生物相容性 血供安全性 便意感知 动物实验 

分 类 号：R318.04[医药卫生—生物医学工程]