高倍率放大电子内窥镜的开发及临床应用  

Development and Clinical Application of High-Magnification Electronic Endoscope

作　　者：王帆 夏建松 杨辉 严国飞 何佳滢 王立强[2] WANG Fan;XIA Jiansong;YANG Hui;YAN Guofei;HE Jiaying;WANG Liqiang(Zhejiang Center for Medical Device Evaluation,Hangzhou,311121;College of Optical Science and Engineering,Zhejiang University,Hangzhou,310027)

机构地区：[1]浙江省医疗器械审评中心,杭州市311121 [2]浙江大学光电科学与工程学院,杭州市310027

出　　处：《中国医疗器械杂志》2024年第6期658-663,共6页Chinese Journal of Medical Instrumentation

摘　　要：该文介绍了一款高倍率放大的电子内窥镜,它采用了连续变焦的光学设计来实现高倍率的放大效果,达到细胞级别的观察水平。通过选择合理的反远距初始结构,系统优化后的变焦物镜MTF接近衍射极限。此外,头端部和操作部采用了模块化气密封装结构和多层保护结构,选择高效密封材料和精密封装工艺技术,确保了系统的密封性能。实验结果表明,常规成像时,物方分辨率达到39.37μm,视场角大于140°;放大成像时,物方分辨率达到2.78μm,观察视场大于800μm×700μm。连接26 in(1 in=2.54 cm)显示器,高倍率放大电子内窥镜可以达到500倍光学放大,能够观察到细胞层面的特征。目前,该产品已成功实现批量生产,并进行多例动物试验,有着广泛的应用前景和显著的临床应用价值。This article introduces a high-magnification electronic endoscope system that utilizes a continuous zoom optical design,enabling high-magnification imaging at the cellular level.By selecting an appropriate initial retrofocus structure,the optimized modulation transfer function(MTF)curve of the zoom objective lens approaches the diffraction limit.Additionally,the tip and operation parts of the system incorporate modular gas-tight sealing and multiple layers of protective structure.The design employs efficient sealing materials and precise packaging techniques to ensure the system’s sealing performance.The experimental results indicate that,under conventional imaging,the resolution is equivalent to 39.37μm in object space,and the field of view angle is larger than 140 degrees.At magnified imaging,the resolution is equivalent to 2.78μm in object space,and the observed actual field of view is greater than 800μm×700μm.When used with a 26-inch display monitor,the high-magnification electronic endoscope can achieve 500×optical magnification,allowing for the observation of features at the cellular level.Currently,this product has successfully achieved mass production and has undergone multiple animal trials,demonstrating its wide range of potential applications and significant clinical value.

关 键 词：高倍率放大电子内窥镜 临床应用 变焦光学系统 密封工艺开发 

分 类 号：R197.39[医药卫生—卫生事业管理] TH773[医药卫生—公共卫生与预防医学]