涡流助推碎石清石输尿管软镜系统的体外与动物试验

Vortex intelligence stone optimized removal system: in vitro and animal experiments

摘要

目的 评价自主研发的涡流助推碎石清石输尿管软镜（VISOR）系统的有效性及安全性。方法 通过体外实验评估VISOR碎石效率与清石能力；通过动物（猪）实验模型观察其对肾盂内压控制、输尿管黏膜的损伤情况及操作安全性。结果 体外实验显示，该系统能有效粉碎并同步清除结石碎片，能做到有效碎石清石。单位质量碎石能耗为（11.06±1.07）J/mg，碎石效率为（2.64±0.31）mg/s，结石清除效率为（1.61±0.22） mg/s。清除结石平均直径为（1.48±0.37） mm，面积为（1.12±0.55） mm²。动物实验证实其操作安全，肾盂内压稳定，未造成严重输尿管黏膜损伤。结论 涡流助推碎石清石输尿管软镜系统能有效碎石清石，操作安全，具有广阔的临床应用前景。

Abstract

Objective To evaluate the efficacy and safety of the Vortex Intelligence Stone Optimized Removal System (VISOR) system. Methods The lithotripsy efficiency and stone-clearing ability of VISOR were assessed through in vitro experiments. Its effect on renal pelvic pressure, the degree of ureteral mucosal injury, and operational safety were observed using an animal (porcine) model. Results In vitro experiments showed that the system could effectively fragment and simultaneously clear stone fragments, with an average cleared stone diameter of (1.48±0.37) mm and an area of (1.12±0.55) mm ². Mass-specific fragmentation energy (MSFE) was (11.06±1.07) J/mg, the fragmentation efficiency was (2.64±0.31) mg/s and the stone clearance efficiency was (1.61±0.22) mg/s. Animal experiments confirmed its operational safety, stable renal pelvic pressure, and absence of severe ureteral mucosal injury. Conclusion The VISOR system can effectively improve the efficiency of lithotripsy and stone clearance, It's safe to operate, and holds broad prospects for clinical application.

关键词

输尿管软镜 / 激光碎石术 / 涡流效应 / 结石清除率

Key words

flexible ureteroscopy / Laser lithotripsy / vortex effect / stone-free rate

参考文献

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基金资助

浙江省医药卫生科技计划项目(2025KY248)

宁波市自然科学基金项目(2025J043)