机器人辅助软性输尿管镜手术系统的体外性能评价和动物体内手术应用研究

A novel robotic-assistant flexible ureteroscopy system: initial results from the in vitro study and the in vivo experience

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,第8~32次安装时间基本稳定,平均为(149.3±8.0)s;卸载时间均平稳,平均为(43.9±5.9)s。两只动物共51个肾盏,B组探查集合系统的完成度高于A组[(95.5±9.1)%与(59.1±9.1)%,P<0.05],探查时间短于A组[(127.3±18.2)s与(274.8±34.6)s,P<0.05]。对于所有术者,Ra-fURS舒适度评分均高于人工操作软镜[(8.9±0.3)分与(5.9±1.1)分,P<0.05]。结论新型机器人辅助软性输尿管镜手术系统具备控制软镜行肾内探查以及联合激光行碎石操作的功能,该系统装卸便捷、性能稳定、使用舒适,在一些基本应用中可降低手术经验差异的影响。

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±141.2)s(P<0.01).In animal surgery,the installation time of Ra-fURS gradually shortened within the first 7 cases was(234.0±43.0)s,and became comparable in the later 8-32 cases was(149.3±8.0)s.The average uninstall time was(43.9±5.9)s and was relatively stable.There were 51 renal calyxes in two pigs.It was higher for the completion rate of calyxes exploration in group B than in group A[(95.5±9.1)%vs.(59.1±9.1)%,P<0.05],and the exploration time was also statistically variant between the two groups group A and group B[(274.8±34.6)s vs.(127.3±18.2)s,P<0.05].For all the operators,the comfort scores were favorable to the Ra-fURS as compared to the manual f-URS(8.9±0.3 vs.5.9±1.1,P<0.05).Conclusions This preliminary study demonstrated that the novel Ra-fURS was capable of controlling flexible ureteroscope to perform retrograde intrarenal surgery and fragmenting stones with laser.Besides,other features,including easy installation,stable performance and comfortable manipulating environment,made it easy to use in clinical application.