Preparation, Preclinical Safety and Effectiveness Research of Body Insulated Acupuncture Needle

Tianxin Li, PhD, Professor, Xiaohua Chen, PhD, Associate Professor, Shuiyang Xu , PhD, University of Science and Technology, Beijing; Lu Zhang, PhD, Deputy chief physician, Guangdi Hu, PhD, Chief physician, Jianwu Shen, PhD, Deputy chief physician, Jianhua Fu, PhD, Section chief, Xiyuan Hospital, China Academy of Chinese Medical Sciences.

Abstract: The therapeutic effect of a body insulated acupuncture needle for electrotherapy was explored based on interdisciplinary research. Now, we have successfully prepared the acupuncture needle and applied for the patents. The needle has also passed the test of biocompatibility, skin sensitization, intradermal test, cytotoxicity, and so on. Our research makes full use of modern nanotechnology, applies nanomaterials to the needle preparation, uses plasma vapor deposition technology, scanning electron microscope (SEM), transmission electron microscope (TEM), and other technical methods to characterize the needle body. We have prepared the acupuncture needle that can meet the relevant standard of Chinese medical devices (Standard number: GB 2024-2016) to fulfill clinical application requirements. The study aims to acquire a product that can completely fulfill clinical application requirements and have industrialization conditions to realize the independent research and development on the acupuncture needle product. The new acupuncture needle can realize the targeted electroacupuncture to acupoint at different needling points, such as superficial fascia, deep fascia, nerve trunk, and ganglion, and quantitative control of the therapy process. While solving the poor safety issues caused by the strong electrical sensation of electrotherapy and practicing the idea of precision medicine, “Sancai” Acupuncture therapy of Academician Cheng Shennong could be better achieved. Meanwhile, the difficulty of a fundamental experiment like collecting physiological electrical signals of specific structures in animals can also be solved. The body insulated acupuncture needle can be used to explore the impact of different stimulation and stimulation signals on the treatment and physiotherapy of illness. This application is a real inheritance and development of traditional Chinese medicine by modern medical methods.