北京生物醫(yī)學工程

仿生人工肛門括約肌系統(tǒng)生物相容性及便意感知實驗研究

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

作者：丁紫凡顏國正姜萍萍姚盛健華芳芳周澤潤

單位：上海交通大學電子信息與電氣工程學院（上海 200240）  <p>通訊作者：顏國正，教授。E-mail:[email protected]</p>

分類號：R318.04；TH 772 <p> </p>

出版年·卷·期（頁碼）：2021·40·5（461-470）

摘要：

目的針對人工肛門括約肌（artificial anal sphincter，AAS）長期植入活體后出現(xiàn)的生物相容性不佳、缺乏便意感知能力和血供安全性問題，提出一種仿生人工肛門括約肌系統(tǒng)（bionic artificial anal sphincter，BAAS）并進行實驗評估。方法首先建立仿生人工肛門括約肌系統(tǒng)，系統(tǒng)采用封閉連桿式“三環(huán)”機構(gòu)作為括約肌假體，外覆一體化醫(yī)用硅橡膠薄膜以增強生物相容性，環(huán)臂嵌入10路壓力傳感模塊，并采用經(jīng)皮無線能量傳輸和無線通信實現(xiàn)體內(nèi)外系統(tǒng)能量供給與信息交互。然后進行體外實驗，以評估括約肌假體的控便能力與血供安全性，并創(chuàng)新地利用壓力向量相似度作為便意判斷的新標準建立便意智能感知模型。最后進行動物實驗，對BAAS系統(tǒng)整體植入效果、生物相容性、控便及便意感知能力等進行觀察和評估。結(jié)果體外實驗表明，括約肌假體對腸道內(nèi)容物的蓄控效果滿足便意閾值需求，且最大夾持壓力在腸道血供安全性范圍內(nèi)，滿足控便和血供安全性要求。動物實驗表明括約肌假體具有良好的密封性和生物相容性，驗證了便意智能感知模型的可靠性，體內(nèi)便意預(yù)警準確率最高可達80%。結(jié)論BAAS系統(tǒng)可以模擬肛門括約肌的功能，作為治療重度肛門失禁的方法。

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.

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