基于MEMS技术的压力感应内藏式膀胱造瘘器的设计与安全性检测  

Designment and Safety Tests of a Pressure-monitoring Built-in Bladder Ostomy Device Based on MEMS Technology

作　　者：林婷婷[1] 陈烨辉 李晓东[1] 许宁[1] 孙雄林[1] 魏勇[1] 薛学义[1] 郑清水[1] LIN Tingting;CHEN Yehui;LI Xiaodong(Department of Urology,the First Affiliated Hospital of Fujian Medical University,Fuzhou City,Fujian Province 350005)

机构地区：[1]福建医科大学附属第一医院泌尿外科

出　　处：《医学理论与实践》2019年第13期1972-1974,1983,共4页The Journal of Medical Theory and Practice

基　　金：福建省医学创新课题资助项目(2015-CX-24);福建省社会发展高校产学合作资助项目(2017Y4004)

摘　　要：目的:研制一种基于微电子机械系统(Micro electro-mechanical system,MEMS)技术设计,能实时监测膀胱压力又安全的新型内藏式的膀胱造瘘器。方法:运用计算机辅助下MEMS技术设计膀胱造瘘器;按照GB/T16886国家医疗机械生物学评价标准进行细胞毒性实验及致敏实验,评价其安全性。结果:细胞毒性实验显示,实验组细胞毒性反应级别均≤1级,细胞溶解率均<10%,与阴性对照组无明显差别;皮肤刺激实验显示,实验组中,生理盐水浸提液和橄榄油浸提液的原发性刺激指数分别为0.375±0.440与0.375±0.209,对皮肤刺激程度均为极轻微,与空白对照组无明显差别(P分别为0.568与0.765)。结论:该膀胱造瘘器在实验条件下无细胞毒性及致敏性,可进行临床试用,进一步评价其安全性及临床实用性。Objective:To develop a built-in bladder ostomy device based on micro electro-mechanical system (MEMS) technology,which can safely monitor bladder pressure in real time.Methods:The bladder ostomy device was designed by Computer-Aided Design MEMS technology.Cytotoxicity test and sensitization test were performed according to the standards of GB/T16886 biological evaluation of medical device to evaluate its safety.Results:Cytotoxicity test showed that the cytotoxicity reaction levels of the experimental group were all≤1,and the cell lysis rate was <10%,which was not significantly different from the negative control group;Skin irritation test showed that the primary irritation index of physiological saline extract and olive oil extract in the experimental group were 0.375±0.440 and 0.375±0.209,respectively,and the degree of skin irritation was extremely slight,with no significant difference between the experimental group and the blank control group ( P = 0.568 and 0.765,respectively).Conclusion:The bladder ostomy device has no cytotoxicity and sensitization under the experimental conditions and can be clinically tested to further evaluate its safety and clinical utility.

关 键 词：膀胱造瘘器 MEMS技术 安全性检测 

分 类 号：R699[医药卫生—泌尿科学]