A flexible and dissolving traditional Chinese medicine microneedle patch for sleep-aid intervention

About a quarter of the world's population suffers from insomnia, and the number of the insomniacs is gradually increasing. However, the current drug therapy and non-drug therapy sleep-aid methods have certain limitations. In general, the sleep-aid effect of drug therapy is better than that of Non-drug therapy, but western medicine may lead to some side effects and drug abuse. Although the side effects of Chinese Herbal Medicine (CHM) are relatively small, making the herbal decoction is complex and time-consuming. Therefore, exploring a novel sleep-aid method is very significant. In this paper, a flexible and dissolving Traditional Chinese Medicine (TCM) microneedle patch is proposed for sleep-aid intervention. The TCM microneedle patch is a micrometer-scale intrusive object, and the herbal extracts are carried by the patch. The materials, design method, and fabrication process of the microneedle patch have been described in detail. Besides, the mechanical characteristics of the microneedle patch, sleep-aid effect evaluation method, and experimental scheme have been presented. Three microneedle tips with radii of 5 μm, 15 μm, and 22 μm are selected for simulation analysis. Abaqus simulation results indicate that the smaller the radius of the microneedle tip, the smaller the piercing force. Considering that the microneedle should easily penetrate the skin without buckling, that is, the piercing force should be larger than the buckling force, thus 15 μm, instead of 5 μm or 22 μm, is more suitable to be adopted as the radius of the microneedle tip. For the microneedle with the radius of 15 μm, the piercing force is 0.033 N, and the difference between the piercing force and buckling force is 0.036 N. Experimental results demonstrate that the fracture force of the microneedle is about 0.29 N, which is far larger than the piercing force and buckling force. The single-lead EEG signals of the frontal lobe are used to evaluate the sleep-aid effect of the TCM microneedle patch. After sleep-aid intervention on the Anmian and Yintang acupoints using the patches, for most subjects, the ratios of the low-frequency brain wave energies to the high-frequency brain wave energies are increased obviously, indicating that the proposed sleep-aid method is effective.