针对传统中医针刺疗法在疼痛、药物依赖、抑郁等慢性疾病治疗中存在的难以长期坚持的问题，本文结合针刺技术和现代植入式医疗仪器技术，提出植入式电针概念，通过向穴位内植入微型电刺激器实现对上述疾病的中长期治疗。首先，本文提出一种适应植入式电针要求的单穴位电针方法，研制了满足动物实验要求的电针实验装置，以镇痛为评价标准，利用正常、急性关节炎症痛和慢性关节炎症痛大鼠模型，对照现有的双穴位电针方法，对单穴位电针方法的有效性和可能机制进行了详细验证与研究。实验结果表明，单穴位电针方法能够显著提高正常大鼠的伤害性感受阈值，能够显著促进中枢神经系统中内源性阿片肽的释放；单穴位电针能够显著促进急、慢性关节炎症痛模型大鼠中枢神经系统内源性阿片肽的释放，能够显著调节血清中炎症相关细胞因子的浓度。上述结果提示单穴位电针方法具有与现有双穴位电针方法同样有效的镇痛作用，两种方法的作用机制也可能相同。其次，本文综合考虑可植入性、功能性、生物安全性、装置可靠性等多种因素，研制了由体内刺激器和体外控制器组成的植入式电针系统。体内刺激器被植入于穴位皮下，通过体外控制器进行参数调整和能量供应。体内刺激器采用一体化结构设计，尺寸为Φ13×2.6 mm，重0.87 g，测试负载为1 kΩ时的最大输出电流为20 mA，能够满足应用要求。将体内刺激器植入家兔足三里穴位3周后，福尔马林急性炎症痛模型家兔实验证明植入式电针具有显著的镇痛效果；组织学评价和功能测试表明其具有良好的生物相容性及在皮下植入环境中进行中长期工作的能力。最后，本文将植入式电针的基础——单穴位电针方法拓展应用于脑力疲劳对抗研究。结果表明，单穴位电针方法能够显著改善受试者模拟驾驶期间的主观疲劳感受和生理疲劳，具有明显的抗疲劳效果。综上所述，本文研究的植入式电针刺激精确、安全可靠、使用方便，能够实现对慢性疾病的长期治疗，具有重要的临床应用价值。此外，单穴位电针方法是对现有电针方法的重要补充，在电针的穴位特异性研究中具有独特优势，对于临床上一般疾病的治疗也具有使用简便等优势。
Traditional Chinese Acupuncture has been validated effective for various diseases, but it is inconvenient and hard to persevere especially for long-term treatment of chronic diseases, such as pain, drug addiction and depression. With the amalgamation of traditional acupuncture theory and modern medical implants technology, this dissertation presented a new conception, implantable electroacupuncture stimulation (IEAS), to achieve medium and long term electroacupuncture (EA) treatment by implanting a subminiature stimulator into the acupoint.Firstly, uni-acupoint method, a novel EA method based on a single acupoint, was presented and an experimental system for method validation was set up. The effectiveness for pain relief and possible mechanisms of uni-acupoint EA method were studied with the normal, acute inflammatory pain and chronic inflammatory pain rats. For normal rats, uni-acupoint EA significantly enhances their nociceptive thresholds and significantly promotes the releases of endogenous opioid peptides in the central nervous system (CNS); for acute and chronic inflammatory pain rats, uni-acupoint EA also significantly promotes the releases of endogenous opioid peptides in the CNS, and significantly regulates the content levels of cytokines related to inflammation. These results suggest that uni-acupoint EA method is as effective as conventional bi-acupoint EA method, and they may share the same mechanisms.Secondly, the IEAS system had been developed, with a synthetic consideration of implantable capability, functionality, biocompatibility and reliability. It consisted of internal stimulator and external controller. The internal stimulator could be implanted into an acupoint and the external controller was used for parameters adjustment and power supply. The internal stimulator is Φ13 mm × 2.6 mm in size, 0.87 g in weight, and the maximum output current is 20 mA (testing load is 1 kΩ). The system was applied at Zusanli acupoint of rabbit with acute inflammatory pain induced by subcutaneously injection of formalin. The results show that IEAS is effective for pain relief. The internal stimulators work well after being implanted in vivo for 3 weeks, and the histology evaluation shows no damage is caused during the implantation. Finally, as an extended application, uni-acupoint EA method was used in the study of countermeasure to mental fatigue with a simulating driving model. The results show that transcutaneous uni-acupoint EA stimulation inhibits the fatigue by improving subjective sensations and physiological responses. In conclusion, IEAS is accurate, safe, reliable and convenient, and it has important value in long-term clinical treatments. Uni-acupoint method is a good complementarity for existing EA methods, and it has great potential in research of acupoint specificity and is more convenient for the common EA applications.
