This work proposed a programmable pulsed radio-frequency (PRF) stimulator for trigeminal neuralgia (TN) relief on demand. The implantable stimulator is a miniaturized micro-system which integrates a wireless interface circuit, a sensor interface circuit, a PRF pattern generation circuit and a logic controller. The multifunctional stimulator capable of delivering current/voltage stimulation provides the choice of the biphasic sinusoidal, square and patterned waveform for PRF treatment researches. The external handheld device can wirelessly transmit the parameters of frequency, amplitude, pulse duration and repetition rate of the pulse train to the implanted stimulator. While stimulating, the temperature sensor can monitor the operating temperature. The feedback signal is transmitted in medical implanted communication system (MICS). The micro-system is fabricated in a 0.35 μm CMOS process with a chip size of 3.1 × 2.7 mm2. The fabricated chip was mounted on a 2.6 × 2.1 cm2 test board for studying the in vivo efficacy of pain relief by PRF. Animal studies of PRF stimulation and commonly-used medication for trigeminal neuralgia are also demonstrated and the presented results prove that PRF stimulation has greater effectiveness on trigeminal neuralgia relief comparing to the medication. The effectiveness period lasts at least 14 days. The results of neural recording show that the PRF stimulation of trigeminal ganglion (TG) attenuated neuron activities without being severely damaged. Pathology also revealed no lesion found on the stimulated area.

中文翻译：

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双模多功能脉冲射频缓解三叉神经痛刺激器及其动物模型


这项工作提出了一种可编程脉冲射频（PRF）刺激器，用于按需缓解三叉神经痛（TN）。植入式刺激器是一个集成了无线接口电路、传感器接口电路、PRF模式生成电路和逻辑控制器的小型化微系统。能够提供电流/电压刺激的多功能刺激器为 PRF 治疗研究提供了双相正弦波、方波和图案波形的选择。外部手持设备可以将脉冲串的频率、幅度、脉冲持续时间和重复率等参数无线传输到植入的刺激器。在刺激的同时，温度传感器可以监测工作温度。反馈信号在医疗植入通信系统（MICS）中传输。该微系统采用0.35μm CMOS工艺制造，芯片尺寸为3.1×2.7mm2。将制作好的芯片安装在 2.6 × 2.1 cm2 测试板上，用于研究 PRF 镇痛的体内功效。还对 PRF 刺激和常用的三叉神经痛药物进行了动物研究，结果证明，与药物相比，PRF 刺激对三叉神经痛缓解具有更大的效果。有效期至少为14天。神经记录结果表明，PRF刺激三叉神经节（TG）减弱了神经元活动，但没有受到严重损害。病理学也显示受刺激区域没有发现病变。