神经调控方法在脑深部刺激、脊髓电刺激、迷走神经刺激等方面得到了越来越广泛的应用,其临床效果已得到业界的广泛认可。植入神经刺激器的小型化一直是技术追求的目标,其价值不仅仅在于微创植入带来的临床需求,还在于临床需求要求提供更加复杂的功能,如何提高空间的利用效率成为矛盾的核心。本文研究从植入电刺激安全性角度分析了电路小型化设计的限制因素及对应的边界条件,提出对应的刺激电路及配套的升压电源电路芯片级解决方案,并通过电路仿真及芯片流片后的测试数据验证了电路小型化方案的可行性。主要的工作如下所述:(1)从刺激安全性角度,研究分析影响电路小型化的主要因素与主要矛盾,基于电极-神经组织界面模型,结合神经组织安全性指标,采用仿真的方式,量化电荷误差边界,对现有电路系统难以实现小型化的限制因素做定性分析;(2)研究了通过电路结构的改变实现特定电路性能指标的方式。通过系统级策略优化、电路理论分析、电路仿真等手段,提出一种能够有效解决刺激安全性的两相电刺激解决方案,用芯片设计实现了这一设计,并通过电路仿真与界面电学模型以及流片后的芯片测试验证上述方案的可行性。(3)研究了刺激器电源部分供电需求,提出一种适配性强的升压电源解决方案,用电源结构优化的芯片设计实现了有限体积下的超低功耗,并通过电路仿真、后续芯片测试验证设计的可行性。 测试结果显示上述两款芯片具有更加优良的性能指标,可以用于未来的植入刺激器系统。
The implantable nerve stimulator has a wide range of clinical applications in deep brain stimulation, spinal cord stimulation and vagus nerve stimulation, and its functions and efficacy have been widely recognized by the industry. At present, the bottleneck of its further popularization and application is that the circuit volume of the active implantable nerve stimulator is difficult to be smaller, which causes the limitation to further minimally invasive surgery application. In this paper, the circuit miniaturized limitation (safety factors) and corresponding boundary conditions are studied. And this paper proposes a corresponding chip level solution for stimulation circuit and boost voltage power supply circuit at the same time. Then the author verifies the feasibility and effectiveness of the above methods through circuit simulation and chip test.The primary study includes the following aspects.(1) This paper analyse the main factor and contradiction of the circuit miniaturization, basing on electrode-neuron tissue interface model, combining with neuron tissue’s security criterion, with the method of simulation, then calculate the charge error boundary. A qualitative analysis of the limitations of the existing circuit system to be further miniaturized and a quantitative index of the relevant circuit performance are proposed.(2) Further, this paper shows a circuit structure to realize the specific circuit performance. Using the methods like system strategy optimization, circuit theory analysis, and circuit simulation, a technical solution (biphasic stimulator circuit design) that can effectively solve the above problems is proposed. Moreover, this paper verifies the effectiveness, feasibility and efficiency of the proposed scheme with circuit simulation. (3) Then, a power supply solution (charge pump design) with high adaptability to boost voltage is proposed, which is applied to pump the high voltage to supply the stimulator circuit. This technical solution optimizes the power structure design and solves the power supply requirement through the way of ultra low power chip design. Chip test result shows this solution’s effectiveness, feasibility and efficiency.Finally, these solutions are realized with chip fabrication and chip test to further confirm the validity, feasibility and advance of these schemes, with the comparison with similar designs. In addition, test results prove the reliability and security of the system at the same time.