一次性电子内窥镜插入管前端弯曲优化及临床验证研究

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DOI:10.19981/j.CN23-1581/G3.2026.11.011

中图分类号：R197.39

文献标志码:A

文章编号:2095-2945(2026)11-0051-04

Abstract: To overcome the high costs, complicated reprocessing, and risk of cross-infection associated with reusable endoscope, this study improved the distal bending capability of a domestically manufactured single-use electronic bronchoscope. This paper proposes a staggered cascaded multi-hinge articulation section, achieving 275° lateral curling and addressing the challenges of conventional articulation sections in bidirectional bending and operational jitter. In a single-center, randomized, parallel-controlled clinical trial involving 28 participants comparing the prototype with an Olympus reusable bronchoscope, both the primary outcome-device usage success rate-and the secondary outcome-bronchoalveolar lavage fluid (BALF) recovery rate-met the predetermined non-inferiority standards. These findings show that the prototype is safe and effective, laying the groundwork for domestic single-use bronchoscopes to replace imported models.

Keywords: single-use electronic endoscope; bronchoscope; distal-tip bending optimization; clinical feedback; articulation section

内窥镜微创手术已成为现代诊疗的重要支柱，但可重复内窥镜售价百万级/套，医院配置数量不足，患者常需排队，且其细长腔道结构复杂，清洗消毒难度大，2023年奥林巴斯因消毒缺陷召回6.8万台，凸显交叉感染风险。（剩余6358字）