Marchini Giovanni Scala, Batagello Carlos A, Monga Manoj, Torricelli Fábio César Miranda, Vicentini Fabio C, Danilovic Alexandre, Srougi Miguel, Nahas Willian C, Mazzucchi Eduardo
1 Section of Endourology, Division of Urology, Hospital das Clínicas, University of Sao Paulo Medical School , Sao Paulo, Brazil .
2 Glickman Urological and Kidney Institute , Cleveland Clinic, Cleveland, Ohio.
J Endourol. 2018 Mar;32(3):184-191. doi: 10.1089/end.2017.0785. Epub 2018 Jan 5.
To compare the manufacturing and in vitro performance characteristics of two single-use flexible ureteroscopes with a permanent optical flexible ureteroscope.
Two single-use flexible ureteroscopes, LithoVue (Boston Scientific) and Pusen (1rs. generation; Zhuhai Pusen Medical Technology Company Limited, China), were tested and compared with a permanent Flex-X ureteroscope (Karl Storz, Germany) in terms of technical characteristics, optics, deflection mechanism, and additional parameters which could potentially affect surgical technique.
Pusen was the lightest ureteroscope while the LithoVue had the longest working length. LithoVue had a higher resolution power than the other two ureteroscopes at all distances tested (p < 0.001). Pusen showed higher resolution than Flex-X (p < 0.01). Field of view was wider for LithoVue (87°), followed by Flex-X (85°) and Pusen (75°). Color representation was superior for Flex-X than LithoVue and then Pusen. LithoVue outperformed Pusen and Flex-X for all settings with instruments in terms of deflection loss (p < 0.01). Pusen had the highest irrigation flow (52 mL/min) with an empty working channel (p < 0.01). LithoVue and Pusen showed similar flow rates with a 200 μm (21 mL/min) and 365 μm laser fiber (7 mL/min) and 1.3F basket (18 mL/min), being superior to Flex-X (p < 0.01). With the 1.9F basket, LithoVue had superior flow rate (7 mL/min) than Pusen (3.5 mL/min) and Flex-X (4 mL/min; p = 0.01).
LithoVue outperformed the other ureteroscopes in terms of optical resolution, field of view, deflection capacity, and irrigation flow with larger instruments. Pusen is the lighter scope and showed better results in terms of irrigation when no instruments are in place. Flex-X was superior in terms of color representation.
比较两款一次性使用软性输尿管镜与一款永久性光学软性输尿管镜的制造工艺及体外性能特点。
对两款一次性使用软性输尿管镜，即LithoVue（波士顿科学公司）和普适恩（第一代；珠海普适恩医疗器械科技有限公司，中国），与一款永久性Flex-X输尿管镜（卡尔史托斯，德国）在技术特性、光学性能、偏转机制以及可能影响手术技术的其他参数方面进行测试和比较。
普适恩是最轻的输尿管镜，而LithoVue的工作长度最长。在所有测试距离下，LithoVue的分辨率均高于其他两款输尿管镜（p < 0.001）。普适恩的分辨率高于Flex-X（p < 0.01）。LithoVue的视野更宽（87°），其次是Flex-X（85°）和普适恩（75°）。Flex-X的色彩表现优于LithoVue，然后是普适恩。在器械处于所有设置状态时，LithoVue在偏转损失方面优于普适恩和Flex-X（p < 0.01）。普适恩在工作通道为空时的冲洗流量最高（52毫升/分钟）（p < 0.01）。LithoVue和普适恩在使用200μm（21毫升/分钟）和365μm激光光纤（7毫升/分钟）以及1.3F篮子（18毫升/分钟）时显示出相似的流速，优于Flex-X（p < 0.01）。使用1.9F篮子时，LithoVue的流速（7毫升/分钟）优于普适恩（3.5毫升/分钟）和Flex-X（4毫升/分钟；p = 0.01）。
LithoVue在光学分辨率、视野、偏转能力以及使用较大器械时的冲洗流量方面优于其他输尿管镜。普适恩是较轻的输尿管镜，在未放置器械时冲洗效果更好。Flex-X在色彩表现方面更具优势。
