Research and development of sterile electrode acupuncture needle for single use based on medicine-engineering integration and its clinical application.
10.13703/j.0255-2930.20250421-k0008
- Author:
Wanying XIA
1
;
Tianxin LI
2
;
Lingli QIN
3
;
Yue GAO
1
;
Hanxi DAI
1
;
Jie ZHANG
4
;
Jinsheng YANG
5
;
Lu ZHANG
3
Author Information
1. Graduate School of Beijing University of CM, Beijing 100029, China.
2. College of Energy and Environmental Engineering, University of Science and Technology Beijing.
3. Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing
4. Center for Cooperation in Science and Technology of TCM, China Academy of Chinese Medical Sciences.
5. Institute of Basic Theory of TCM, China Academy of Chinese Medical Sciences.
- Publication Type:Journal Article
- Keywords:
insulation;
medicine-engineering integration;
precise electrical stimulation;
sterile electrode acupuncture needle for single use
- MeSH:
Humans;
Needles;
Acupuncture Therapy/instrumentation*;
Electrodes;
Equipment Design;
Electroacupuncture/instrumentation*;
Acupuncture Points;
Animals
- From:
Chinese Acupuncture & Moxibustion
2025;45(10):1527-1532
- CountryChina
- Language:Chinese
-
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.
