经尿道手术机器人的性能评价和应用研究

Development and application of a new transurethral surgical robot

目的评价新型主从操作式经尿道手术机器人系统的性能,验证其安全性和有效性。方法2021年9月北京协和医院2名泌尿外科医生(A和B)应用经尿道手术机器人样机进行仿真人体组织模型实验。本研究采用的经尿道手术机器人系统包括:主端控制平台、从端手术平台和末端执行器。主端控制平台采用Omega7力反馈主手作为主控制器,自由度包括:上下平移、左右平移、前后平移、末端旋转、末端俯仰、末端摆动、末端操作。从端手术平台采用Med7七自由度医疗协作机械臂,通过末端执行器操作电切镜。末端执行器采用模块化设计,最大化兼容现有手术器械。2名医生均分别常规组装电切镜和经尿道手术机器人各20次,计算组装时间。常规组装电切镜时间包括电切镜安装、连接镜头和光源后,医生手持电切镜进入实验模块的时间。组装手术机器人时间包括将电切镜与末端执行器安装,并连接镜头和光源后进入实验模块的时间。2名医生分别进行25次模拟前列腺电切手术和5次模拟膀胱电切手术。将猪的小肠、心脏和胃缝合构建模拟人体的尿道、前列腺和膀胱结构:尿道(猪小肠)长16~18cm,前列腺(猪心脏)大小约5cm×5cm×6cm,膀胱(猪胃)容量250~300ml。将模型置于3D打印套盒中,模拟尿道与硅胶阴茎贴合。模拟前列腺电切手术:医生于主端控制平台操作手柄,通过人机交互控制从端执行器,直视下围绕不动点切除“前列腺”,模拟标准经尿道前列腺切除术,切除范围为从模拟膀胱颈至模拟前列腺尖部,切除两侧叶和中叶。每次手术时间40min,记录切除组织重量。模拟经尿道膀胱电切手术:每次手术需切除模拟膀胱的三角区、两侧壁和顶部区域,记录是否发生穿孔。通过手术对机器人的主从操作距离准确度、操作姿态准确度、主从操作姿态重复度、不动点准确度、主从控制启动延迟时间和主从控制跟随延迟时间、机械臂摆动范围、极限位点等指标进行验证。结果经尿道手术机器人性能测试结果显示,末端执行器定位精度<0.5mm,主从操作距离准确度≤0.5mm,重复性距离≤0.2mm;主从操作姿态准确度角度a≤0.30°,角度b≤0.30°,角度c≤0.15°;不动点准确度≤0.6mm,机械臂最大活动空间为半径(1493±5)mm的半球形空间。主从控制启动延迟时间和主从控制跟随延迟时间均≤100ms。从端机械臂末端在运动中受到外力碰撞时,系统可自动停止机械臂运动,此时外力为(70±7)N;不动点设置范围30~170mm。医生A和医生B组装经尿道手术机器人时间分别为(111.35±57.88)s和(111.70±58.30)s(P=0.996),常规组装电切镜时间分别为(44.90±4.89)s和(44.90±5.16)s(P=0.679),2名医生间比较差异均无统计学意义;2名医生的机器人组装时间均多于常规组装时间,差异均有统计学意义(P=0.001,P=0.001)。随组装次数增加,机器人组装时间进行性下降,5次组装后时间稳定≤120s。医生A和医生B切除的前列腺组织重量分别为(43.60±12.42)g和(43.45±12.63)g,差异无统计学意义(P=0.954)。模拟膀胱电切手术中,机器人系统可顺利完成模拟膀胱的三角区、两侧壁和顶部组织切除。手术实验中系统运行流畅,未发生机械故障,无模块损伤、穿孔等并发症发生。结论经尿道手术机器人能够安全、有效地完成经尿道电切手术。

Objective To evaluate the performance of a novel master-slave transurethral surgical robot system and test its safety and effectiveness.Methods In September 2021,two urologists(A and B)applied transurethral surgery robot prototype on simulate human tissue model experiments.The transurethral surgical robotic systems used in this study include:master-end control platform,slave-end surgical platform,and end-effector.The main end control platform adopted Omega7 force feedback main hand as the main controller,and the degrees of freedom include:up and down translation,left and right translation,front and back translation,end rotation,end pitch,end swing,end operation.The end-operated surgical platform adopts the Med 7 seven-degree-of-freedom medical collaborative robotic arm to apply precision through the end effector operated resectoscope.The end effectors were modular in design for maximum compatibility with existing surgical instruments.The two doctors routinely assembled the resectoscope and the transurethral surgical robot 20 times each to calculate the assembly time.The routine assembly time of the resectoscope included the time when the lens and light source were connected after the resectoscope had been installed,and the doctor entered the experimental module with the resectoscope in hand.The time to assemble the surgical robot included the time to install the resectoscope with the end effector and connect the lens and light source to enter the experimental module.Two doctors performed 25 simulated prostate resection and 5 simulated bladder resection procedures.The small intestine,heart and stomach of pigs were sutured to construct urethra,prostate and bladder structures that simulated human body:urethra(pig small intestine)was 16-18 cm long,prostate(pig heart)size was about 5 cm×5 cm×6 cm,and bladder(pig stomach)capacity was 250-300 ml.The model was placed in a 3D printed sleeve to simulate the ftting of the urethra to the silicone penis.Prostate resection surgery:the doctor operated the handle on the main end control platform,controld the slave actuator through human-computer interaction,and excisesed the"prostate"around the fixed point under direct vision,simulating standard transurethral prostatectomy,the resection ranges from the bladder neck to the tip of the prostate,and the two lobes and middle lobes were removed.Each operation lasted 40 minutes and the weight of the removed tissue was recorded.Transurethral esection of the bladder:each procedure involved removal of the triangle,bilateral walls,and apical area of the bladder to record the occurrence of perforation.The accuracy of master-slave operating distance,operation attitude accuracy,master-slave operation attitude repeatability,fixed point accuracy,master-slave control start delay time and master-slave control following delay time,robotic arm swing range,limit site and other indicators of the robot wcre verified by surgery.Results The positioning accuracy of the end effector of transurethral surgical robot was less than 0.5 mm,the accuracy of master-slave operation distance was≤0.5 mmthe repeatability distance was≤0.2 mm,the accuracy of master-slave operation attitude was a≤0.30°,the angle b≤0.30°,the angle C≤0.15°,the accuracy of the fixed point≤is 0.6 mm,the maximum activity space of the robotic arm was a hemispherical space with a radius of(1493±5)mm.The delay time of master-slave control startup and master-slave control follow-up delay time did not exceed 10Oms;When the end of the manipulator was collided by an external force during the movement,the system could automatically stop the movement of the manipulator,at this time the external force was(70±7)N,and the fixed point seting range was 30-170 mm.The assembly time of transurethral surgery robot by Doctor A and Doctor B was(111.35±57.88)s and(111.70±58.30),respectively.The time of routine assembly resectoscope was(44.90±4.89)s and(44.90±5.16)s,respectively,and the difference between the routine assembly time and robot assembly time of Doctor A and Doctor B were not statistically significant(P=0.679 and P=0.996),the assembly time of the two doctor robots was more than the conventional assembly time(P=0.001 and P=0.001).The average weight of prostate tissue resection in experiments was(43.60±12.42)g and(43.45±12.63)g,respectively.No significant difference was found between them(P=0.954).During the simulated bladder electrosurgery,the robot system could successfully complete the resection of the triangular region,bilateral walls,and top tissues of the bladder.In the surgical experiment,the system operated smoothly without mechanical failure,module damage,perforation,and other complications.Conclusions The transurethral surgery robot might be a choice for transurethral surgery.