摘要
目的评价新型机器人辅助软性输尿管镜手术系统(Ra-fURS)的性能,并探讨应用该系统行动物手术的可行性、效果和安全性。方法2020年10月使用自主研发的机器人辅助软性输尿管镜手术系统,配合软性输尿管镜进行研究。研究分为3个部分。第一部分为体外基本性能测试,包括:①Ra-fURS控制软镜的3个自由度运动范围(上/下弯曲角度、轴向旋转角度、前后进退距离);②操作相应延迟;③Ra-fURS操控光纤前后运动距离。第二部分为模拟软镜手术,术者为8名泌尿外科医生,分为A、B两组,每组4名。A组无主刀经验,B组手术经验均>200例。两组术者均采用3D打印肾脏模型测试Ra-fURS探查所有肾盏的完成度(探查肾盏数/肾盏总数)和时间;集合系统内定向移位时间;激光碎石时间(结石模型为0.5 cm×0.5 cm×0.5 cm石膏块)。第三部分为动物软镜手术,实验对象为5个月龄雌性约克夏长白猪2只。两组术者对实验动物行双侧输尿管软镜探查,共完成32次Ra-fURS手术。记录每次Ra-fURS安装时间和卸载时间,以及Ra-fURS探查所有肾盏的完成度和时间。每次Ra-fURS术后,术者需行1次人工操作软镜,并对Ra-fURS和人工操作的舒适度评分(术者手指、腕、肘、肩、腰、膝每个部位,明显不适为0分,轻度不适评分为1分,无不适评分为2分,合计0~12分)进行比较。比较两组术者各项观察指标的差异。结果Ra-fURS控制软镜实施3个基本自由度运动行程分别为进/退+11~-11 cm、轴向旋转+225°~-225°、主动弯曲+270°~-270°,操作光纤的进退行程为+2.5~-2.5 cm。体外模型下,A、B组探查集合系统的完成度均为100%;探查时间分别为(116.0±8.0)s和(110.3±15.4)s,定向移位时间分别为(71.3±16.4)s和(64.3±5.9)s,差异均无统计学意义(P>0.05);B组模拟碎石时间短于A组[(525.8±58.5)s与(780.5±141.2)s,P<0.01]。动物手术中,第1~7次Ra-fURS安装时间平均为(234.0±43.0)s,呈下降趋势,�
Objective Objectives The aim of the study is to evaluate the mechanical performance,safety and efficacy of the novel robotic-assistant flexible ureteroscopy system(Ra-fURS)under in vitro and in vivo environments.Methods Combing with commercial flexible ureteroscopes,the novel Ra-fURS was used for the in vitro test and animal model operation in October 2020.The study included three sections.①Basic mechanical performance assessment:including endoscope motion control(dual deflection,axial rotation and forward/backward distance),reaction time and fiber regulation.②Simulated surgery in ex-vivo 3D-printing renal collecting system model:including completion rate and time of calyxes exploration,directional movement and laser fragmentation[gypsum models(0.5×0.5×0.5 cm)were used to stimulate kidney stones].③Intrarenal surgeries in animal models(two 5-month female Yorkshire white pigs).In total,32 surgeries was performed(8 surgeons×2 pigs×2 kidneys/pig).In vivo assessments were carried out including:①consuming time for Ra-fURS installation and offloading;②completion rate and time of calyxes exploration;③comfort score(ranging from 0-10)as compared to the manual f-URS,which was corresponding to each Ra-fURS surgery.In simulated surgery and animal surgery sections,8 surgeons were enrolled in the study(group A 4 without flexible ureteroscopy experience;group B:4 highly experienced),and results were compared between two groups.Results Under the Ra-fURS control,the flexible ureteroscope movement in three degrees of freedom(forward/backward:+11 to-11 cm,axial rotation+225°to-225°;active duel-flection:+270°to-270°,as well as the laser fiber regulation+2.5 to-2.5 cm).In simulated surgery tests,both groups achieved 100%completion rate of calyxes exploration,and there were no statistical differences in the time of the calyxes exploration between group A and group B(116.0±8.0)s vs.(110.3±15.4)s(P>0.05).Time-consumption for laser fragmentation of group B was shorter than that of group A(525.8±58.5)s vs.(780.5±141
作者
李凌
王则宇
董浩
彭泳涵
方梓宇
明少雄
谢飞
芦超跃
高小民
李锐
万洋
高小峰
Li Ling;Wang Zeyu;Dong Hao;Peng Yonghan;Fang Ziyu;Ming Shaoxiong;Xie Fei;Lu Chaoyue;Gao Xiaomin;Li Rui;Wan Yang;Gao Xiaofeng(Department of Urology,Changhai Hospital,Shanghai 200433,China)
出处
《中华泌尿外科杂志》
CAS
CSCD
北大核心
2022年第8期607-613,共7页
Chinese Journal of Urology
基金
国家重点研发计划课题(2017YFB1302804)。
关键词
机器人手术
软性输尿管镜
肾脏内镜手术
肾结石
动物模型手术
Robotic surgical procedures
Flexible ureteroscope
Combined intrarenal surgery
Renal calculi
Animal surgical model
