现代仪器与医疗

国产高端腔镜系统及配套微创器械的多中心、多层级应用示范研究

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王之晨 ^1a , 张倩 ^1a^,^b , 孙斐 ^1a , 孙静 ^1a^,^b , 吴李鸣 ² , 冯靖祎 ^1a^,^b^,^*

现代仪器与医疗 | 腔镜系统应用示范与评价技术 2026,32(4): 10-19

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现代仪器与医疗 |腔镜系统应用示范与评价技术 2026 , 32 (4) : 10 -19

国产高端腔镜系统及配套微创器械的多中心、多层级应用示范研究

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王之晨^1a, 张倩^1a^,^b, 孙斐^1a, 孙静^1a^,^b, 吴李鸣², 冯靖祎^1a^,^b^,^*

作者信息

^1a.浙江大学医学院附属第一医院　医学工程部，杭州　310003

^b.浙江大学医学院附属第一医院　全省医疗器械临床评价技术研究重点实验室，杭州　310003

²浙江大学医学院附属第四医院普外科，义乌　322000

通讯作者:

冯靖祎，女，硕士研究生，研究员，研究方向：医疗器械管理、评价和应用示范

作者简介:

王之晨，男，硕士研究生，工程师，研究方向：医疗器械可用性评价

Multicenter and multilevel application demonstration of domestic high-end endoscopic systems and associated minimally invasive surgical instruments

Zhichen Wang^1a, Qian Zhang^1a^,^b, Fei Sun^1a, Jing Sun^1a^,^b, Liming Wu², Jingyi Feng^1a^,^b^,^*

Affiliations

^1a.Department of Clinical Engineering, Zhejiang University School of Medicine, Hangzhou 310003, China

^b.Zhejiang Key Laboratory of Clinical Evaluation Technology for Medical Device, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China

^2.Department of General Surgery, the Fourth Affiliated Hospital, Zhejiang University School of Medicine, Yiwu 322000, China

出版时间: 2026-08-10 doi: 10.11876/mimt202604002

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摘要

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目的

评价国产高端腔镜系统及配套微创器械在多中心、多层级示范网络中的临床应用及适配情况，分析中心示范、基层承接与企业服务保障的协同运行机制。

方法

采用“中心示范点—基层示范点—基线调研医院”三层架构，于2022年11月至2025年10月期间开展覆盖全国六大区域、3大专科的国产高端腔镜系统及配套微创器械应用示范。纳入中心示范点10家、基层示范点11家；基线调研覆盖27个省（自治区、直辖市）的320家医疗机构，其中三级医院263家、二级医院57家。基线资料比较不同层级医院设备配置和培训能力，示范期资料归纳代表性术式开展、基层承接、培训覆盖及平台运行情况。

结果

荧光腔镜系统、3D腔镜系统和三维重建软件系统配置率在三级与二级医院间差异有统计学意义（均P<0.001）；所有二级医院均缺乏荧光腔镜系统和4K荧光腔镜系统两类技术的独立培训能力。示范期3大专科累计完成腔镜微创手术35 000余例，精准肺段切除、精准左半肝切除、精准胰十二指肠切除、前列腺癌根治术和肾部分切除术等在中心示范点常规开展，主要术式技术完成情况维持在97%以上。部分基层示范点腔镜手术量、微创手术占比或本地承接能力提高，秦皇岛市第二医院腔镜手术占比由不足10%提升至约40%，渭源县人民医院腹腔镜前列腺癌根治术实现从无到有。数字化平台注册用户3 156人，覆盖医疗机构1 627家，收录手术视频1 000余部。

结论

国产高端腔镜系统及配套微创器械已在示范网络内形成多中心、多层级应用经验。中心医院开展复杂术式示范和规范输出，基层医院承接常规术式，企业提供设备入装、培训、维保和反馈改进服务，设备临床适配取决于术式、人员、服务和数据采集的协同配置。

关键词

腔镜系统 / 国产医疗器械 / 微创外科 / 应用示范 / 中心-基层联动 / 真实世界数据

Abstract

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Objective

To evaluate the clinical application and adaptability of domestic high-end endoscopic systems and associated minimally invasive surgical instruments within a multicenter, multilevel demonstration network, and to analyze the coordinated operation mechanism of central demonstration, primary-level adoption, and enterprise service support.

Methods

A three-tier structure comprising central demonstration sites, primary-level demonstration sites, and hospitals participating in the baseline survey was established across six major regions of China and three major specialties from November 2022 to October 2025. The network included 10 central demonstration sites and 11 primary-level demonstration sites. The baseline survey covered 320 medical institutions in 27 provinces, autonomous regions, and municipalities, including 263 tertiary hospitals and 57 secondary hospitals. Baseline data were used to compare equipment configuration and training capacity between different hospital levels. Data collected during the demonstration period were used to summarize representative procedures, primary-level adoption, training coverage, and platform operation.

Results

The configuration rates of fluorescence endoscopic systems, three-dimensional endoscopic systems, and three-dimensional reconstruction software differed significantly between tertiary and secondary hospitals (all P<0.001). All secondary hospitals lacked independent training capabilities for fluorescence endoscopy systems and 4K fluorescence endoscopy systems. During the demonstration period, more than 35,000 minimally invasive endoscopic procedures were performed across the three specialties. Representative procedures, including precision pulmonary segmentectomy, precision left hemihepatectomy, precision pancreatoduodenectomy, radical prostatectomy, and partial nephrectomy, were routinely performed at the central demonstration sites. The reported technical completion rates for the main procedures remained above 97%. Several primary-level demonstration sites showed increases in endoscopic surgical volume, the proportion of minimally invasive procedures, or local procedure adoption. At Qinhuangdao Second Hospital, the proportion of endoscopic surgery increased from less than 10% to approximately 40%; the laparoscopic prostate cancer radical surgery at Weiyuan County People's Hospital was realized from non-existence to existence. The digital platform had 3,156 registered users, covered 1,627 medical institutions, and hosted more than 1,000 surgical videos.

Conclusion

Domestic high-end endoscopic systems and associated minimally invasive surgical instruments have accumulated multicenter, multilevel application experience within the demonstration network. Central hospitals conducted complex-procedure demonstrations and developed standardized practices, primary-level hospitals adopted routine procedures, and enterprises provided equipment installation, training, maintenance, and feedback-based improvement. Clinical adaptability depends on the coordinated implementation of procedure selection, personnel training, service support, and data collection.

Key words

Endoscopic system / Domestic medical device / Minimally invasive surgery / Demonstration program / Hub-and-spoke linkage / Real-world data

引用本文

王之晨, 张倩, 孙斐, 孙静, 吴李鸣, 冯靖祎. 国产高端腔镜系统及配套微创器械的多中心、多层级应用示范研究. 现代仪器与医疗, 2026 , 32 (4) : 10 -19 . DOI: 10.11876/mimt202604002

Zhichen Wang, Qian Zhang, Fei Sun, Jing Sun, Liming Wu, Jingyi Feng. Multicenter and multilevel application demonstration of domestic high-end endoscopic systems and associated minimally invasive surgical instruments[J]. Modern Instruments & Medical Treatment, 2026 , 32 (4) : 10 -19 . DOI: 10.11876/mimt202604002

基金

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中央引导地方科技发展资金项目(2025ZY01066)
国家重点研发计划(2022YFC2407300; 2022YFC2407301)

参考文献

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参考文献引证文献

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2026年第32卷第4期

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文章信息

doi: 10.11876/mimt202604002

接收时间：2026-06-15
首发时间：2026-10-23
出版时间：2026-08-10

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收稿日期：2026-06-15

基金

中央引导地方科技发展资金项目(2025ZY01066)

国家重点研发计划(2022YFC2407300; 2022YFC2407301)

作者信息

^1a.浙江大学医学院附属第一医院　医学工程部，杭州　310003

^b.浙江大学医学院附属第一医院　全省医疗器械临床评价技术研究重点实验室，杭州　310003

²浙江大学医学院附属第四医院普外科，义乌　322000

通讯作者:

冯靖祎，女，硕士研究生，研究员，研究方向：医疗器械管理、评价和应用示范

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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