EMS碎石清石系统手控碎石装置研发及临床初步应用的评价  

Development and evaluation of a manual control device for LithoClast system and its preliminary clinical application

作　　者：刘宇保 赵建厂 苏赫 肖博[1] 胡卫国[1] 张刚[1] 付猛[1] 苏博兴[1] 李建兴[1] LIU Yubao;ZHAO Jianchang;SU He;XIAO Bo;HU Weiguo;ZHANG Gang;FU Meng;SU Boxing;LI Jianxing(Department of Urology,Beijing Tsinghua Changgung Hospital,School of Clinical Medicine,Tsinghua University,Beijing 102218;School of Mechanical Engineering,Tianjin University,Beijing 300350,China)

机构地区：[1]清华大学附属北京清华长庚医院泌尿外科,清华大学临床医学院,北京102218 [2]天津大学机械工程学院,北京300350

出　　处：《现代泌尿外科杂志》2022年第11期907-911,共5页Journal of Modern Urology

基　　金：国家自然科学基金面上项目(No.52175028);北京清华长庚医院院内青年基金(No.12015C1025)。

摘　　要：目的设计开发一款基于EMS碎石清石系统能量平台的手控装置,并评价其在PCNL中的临床使用价值。方法1.装置研发方案:该装置由手控开关、电路传输线、继电器和电源系统三部分组成。基于EMS系统主机箱体及原脚踏线路接口设计传输线,中间为继电器和电源组件。2.体外实验选用人工制作仿真肾结石模型浸于生理盐水容器中,用手控开关连续激发3组按键30 s实验3次进行体外效能测试。3.临床应用评价:(1)将40例拟行PCNL的上尿路结石患者分为两组,分别采用手控装置及脚控踏板行碎石手术,针对手控组分析手术的完成情况、平均总手术时间、平均手控碎石时间、净石率及手术并发症。(2)设计术者《PCNL手控碎石评分表》对手控及脚踏两种碎石操控方式进行评估,分别在手术舒适度、碎石灵活度、下肢疲劳缓解程度和整体满意度(各项100分)4个方面进行对比评价。结果该手控装置研发成功且功能运行良好,套入式及操控特点均符合人体力学和使用习惯。体外效能测试顺利且运行期间无机械故障,体外碎石效果满意。20台PCNL手术均顺利完成且无碎石中断或更换脚控方式,平均总手术时间75.1 min,平均手控碎石时间37.8 min、净石率85.0%,无Clavien Dindo≥Ⅱ级并发症的发生。《PCNL手控碎石评分表》中手控装置在4个方面均优于传统的脚控装置,差异有统计学意义(P<0.05)。结论EMS碎石清石系统的手控碎石装置作为传统脚控碎石装置的改良或替换模式可有效缓解术者的下肢疲劳程度,提升PCNL碎石过程的整体舒适度,可优化并改善手术的灵活性及可操控性,具有较高的临床推广意义和实用性。Objective To design and develop a manual control device for EMS LithoClast system,and to evaluate its clinical application value in PCNL.Methods Device development scheme:The device was composed of three parts,hand-controlled switch,circuit transmission line,relay and power supply system.The transmission line was designed based on the interface between the main body of EMS system and the original foot line,with relay and power supply component in the middle.In vitro performance test:Raw gypsum was selected to establish artificially simulated renal stone model immersed in physiological saline container,and the manually controlled switch was used to continuously stimulate three groups of buttons for 30 seconds.Evaluation of clinical application:(1)Forty patients with upper urinary stones who planned to receive PCNL were selected to undergo surgery with the hand-controlled device.The operation completion,mean total operation time,mean manual lithotripsy time,stone-free rate and surgical complications were analyzed.(2)The operator’s“PCNL Manual Lithotripsy Evaluation Scale”was designed to evaluate the two lithotripsy manipulation methods,and comparative evaluation was conducted in the four aspects of surgical comfort,lithotripsy flexibility,lower limb fatigue relief and overall satisfaction(100 points for each).Results The manual control device was successfully developed and ran well;the fixation mode and control characteristics were in line with human mechanics and habits.The in vitro efficacy test was successful and there was no mechanical failure during operation.The lithotripsy effect was satisfactory.All 20 PCNL operations were successfully completed without interruption or replacement of foot control.The mean operation time was 75.1 min,mean manual lithotomy time was 37.8 min,and stone-free rate was 85.0%.No Clavien Dindo≥Ⅱcomplications occurred.In“PCNL Manual Lithotripsy Evaluation Scale,”the manual control device was superior to the traditional foot control device in the four aspects,with statis

关 键 词：EMS碎石清石系统 手控碎石装置 PCNL 医疗器械研发 

分 类 号：R691.4[医药卫生—泌尿科学]