Research and development of sterile electrode acupuncture needle for single use based on medicine-engineering integration and its clinical application

XIA Wanying; LI Tianxin; QIN Lingli; GAO Yue; DAI Hanxi; ZHANG Jie; YANG Jinsheng; ZHANG Lu

doi:10.13703/j.0255-2930.20250421-k0008

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Research and development of sterile electrode acupuncture needle for single use based on medicine-engineering integration and its clinical application

Tool and Instrument | 更新时间：2025-10-11

- Research and development of sterile electrode acupuncture needle for single use based on medicine-engineering integration and its clinical application
- Chinese Acupuncture & Moxibustion Vol. 45, Issue 10, Pages: 1527-1532(2025)
- 作者机构：
  
  北京中医药大学研究生院，北京　100029
  北京科技大学能源与环境工程学院
  中国中医科学院西苑医院，北京　100091
  中国中医科学院中医药科技合作中心
  中国中医科学院中医基础理论研究所
- 作者简介：
- 基金信息：
- DOI：10.13703/j.0255-2930.20250421-k0008
  CLC：
- Received：21 April 2025，
  
  Online First：25 July 2025，
  
  Published：12 October 2025
- 稿件说明：
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XIA Wanying, LI Tianxin, QIN Lingli, et al. Research and development of sterile electrode acupuncture needle for single use based on medicine-engineering integration and its clinical application[J]. Chinese Acupuncture & Moxibustion, 2025, 45(10): 1527-1532.
DOI：

XIA Wanying, LI Tianxin, QIN Lingli, et al. Research and development of sterile electrode acupuncture needle for single use based on medicine-engineering integration and its clinical application[J]. Chinese Acupuncture & Moxibustion, 2025, 45(10): 1527-1532. DOI： 10.13703/j.0255-2930.20250421-k0008.

摘要

一次性使用无菌电极针灸针是一种结合了传统针灸与现代电子技术的创新产品，现已取得国家Ⅱ类医疗器械注册证。该针灸针由针体和针柄组成，针体直径为0.16~0.55 mm，针体长度为7~150 mm；采用螺旋喷溅技术，在不锈钢材质针灸针针身进行微米级绝缘涂层修饰，针柄连接电针装置（导电）、微米级薄膜绝缘针身（不导电），无膜针尖（导电）可实现对穴位不同组织层次（深部神经、筋膜等）精准的电刺激治疗；通过了皮内刺激试验、细胞毒性试验以及超敏反应试验，展现了良好的生物相容性，为临床应用奠定了安全基础。该针具适用于在医疗机构中配合电针治疗设备，用于人体体表穴位不同深度的侵入式刺激。

Abstract

The sterile electrode acupuncture needle for single use is an innovative product that combines traditional acupuncture with modern electronic technology

and it has obtained Class Ⅱ medical device registration certificate. This acupuncture device consists of a needle body and a handle. The diameter of the needle body ranges from 0.16 mm to 0.55 mm

and the length from 7 mm to 150 mm. The spiral spray technology is adopted to modify the micron-level insulating coat on stainless steel needle body. The needle holder is connected to the electroacupuncture device (conductive)

the micro-film insulated needle body (non-conductive) and the membrane-free needle tip (conductive) can provide a precise electrical stimulation for different tissue layers of acupoints (such as deep nerves and fascia). The intradermal stimulation test

cytotoxicity test and hypersensitivity reaction test have showed a favorable biocompatibility

laying a solid and reliable safety for clinical application. This acupuncture device is suitable for the in-depth invasive stimulation at the sites of human body surface in combination with electroacupuncture equipment in medical institutions.

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