摘要目的:研发一种混合动力超声气压弹道碎石清石系统(EMS)的无线手控操作装置并对其在经皮肾镜碎石术中应用的舒适度和疗效进行评估。方法:对现有瑞士EMS公司碎石系统的脚踏开关进行电路分析，掌握其控制原理，绘制无线控制原理框图，制作样机，进行体外试验，进一步进行初步临床应用与评价。选取2023年5月至2023年9月苏州大学附属第二医院泌尿外科收治的20例行经皮肾镜碎石取石术(PCNL)患者为研究对象，设计《手术易用性、舒适度和碎石效率评分表》，采用简单随机化分组，分为无线手控组和脚控组各10例，对该无线手控系统的易用性、使用舒适度、碎石效率进行评估，使用两独立样本 t检验进行组间比较。 结果:成功研发出无线手控装置样机，体外实验证实可实现无线手控碎石。成功进行无线手控系统的临床应用，结果显示无线手控组的平均易用性得分和平均舒适度得分[(9.70±0.48)、(9.70±0.48)分]均高于脚控组[(6.20±0.79)、(5.30±0.48)分]，差异有统计学意义( t＝11.966、20.368， P<0.01)，两组的平均碎石效率分别为(9.30±0.48)%、(9.40±0.70)%，差异无统计学意义( t＝0.372， P>0.05)。 结论:该EMS无线手控系统能够在保证碎石效率的同时提高手术的舒适度与操作的灵活性。

abstractsObjective:To design a wireless manual control device (WMCD) for the electro medical systems (EMS) lithoclast system and to evaluate its comfort and efficacy in percutaneous nephrolithotomy (PCNL).Methods:We analyzed circuit of foot pedal of the EMS system and perceived its control principle. We then drew the schematic diagram and detailed circuit diagram for the WMCD. Then the prototype device was developed according to the circuit diagram. The data of 20 patients undergoing PCNL from the Department of Urology, the Second Affiliated Hospital of Soochow University from May 2023 to September 2023 were collected. The patients were randomly divided into WMCD group and routine group (10 cases in each group). A score table about ease-of-use, comfort and lithotripsy efficiency was designed to evaluate the difference of the two groups, and independent sample t test was used for comparison between groups. Results:Prototype of WMCD was successfully developed. In vitro experiments proved that WMCD was potent. Clinical application of WMCD was successfully carried out. The results showed that the average ease-of-use score and average comfort score of the WMCD group (9.70±0.48, 9.70±0.48) were significantly greater than those of the routine group (6.20±0.79, 5.30±0.48, t=11.966, 20.368, P<0.01). There was no statistically significant difference in the lithotripsy efficiency between the two groups [(9.30±0.48)%, (9.40±0.70)%, t=0.372, P>0.05]. Conclusion:WMCD for EMS can not only enhance efficiency of lithotripsy, but also improve comfort and flexibility of operation.