Abstract：
OBJECTIVE: This study aimed to indicate the feasibility of a prototype electrical neuromodulation system using a closed-loop energy-efficient ultrasound-based mechanism for communication, data transmission, and recharging.
METHODS: Closed-loop deep brain stimulation (DBS) prototypes were designed and fabricated with ultrasonic wideband (UsWB) communication technology and miniaturized custom electronics. Two devices were implanted short term in anesthetized Göttingen minipigs (N = 2). Targeting was performed using preoperative magnetic resonance imaging, and locations were confirmed postoperatively by computerized tomography. DBS systems were tested over a wide range of stimulation settings to mimic minimal, typical, and/or aggressive clinical settings, and evaluated for their ability to transmit data through scalp tissue and to recharge the DBS system using UsWB.
RESULTS: Stimulation, communication, reprogramming, and recharging protocols were successfully achieved in both subjects for amplitude (1V-6V), frequency (50-250 Hz), and pulse width (60-200 μs) settings and maintained for ≥six hours. The precision of pulse settings was verified with <5% error. Communication rates of 64 kbit/s with an error rate of 0.05% were shown, with no meaningful throughput degradation observed. Time to recharge to 80% capacity was <9 minutes. Two DBS systems also were implanted in the second test animal, and independent bilateral stimulation was successfully shown.
CONCLUSIONS: The system performed at clinically relevant implant depths and settings. Independent bilateral stimulation for the duration of the study with a 4F energy storage and full rapid recharge were achieved. Continuous function extrapolates to six days of continuous stimulation in future design iterations implementing application specific integrated circuit level efficiency and 15F storage capacitance. UsWB increases energy efficiency, reducing storage requirements and thereby enabling device miniaturization. The device can enable intelligent closed-loop stimulation, remote system monitoring, and optimization and can serve as a power/data gateway to interconnect the intrabody network with the Internet of Medical Things.
METHODS: Closed-loop deep brain stimulation (DBS) prototypes were designed and fabricated with ultrasonic wideband (UsWB) communication technology and miniaturized custom electronics. Two devices were implanted short term in anesthetized Göttingen minipigs (N = 2). Targeting was performed using preoperative magnetic resonance imaging, and locations were confirmed postoperatively by computerized tomography. DBS systems were tested over a wide range of stimulation settings to mimic minimal, typical, and/or aggressive clinical settings, and evaluated for their ability to transmit data through scalp tissue and to recharge the DBS system using UsWB.
RESULTS: Stimulation, communication, reprogramming, and recharging protocols were successfully achieved in both subjects for amplitude (1V-6V), frequency (50-250 Hz), and pulse width (60-200 μs) settings and maintained for ≥six hours. The precision of pulse settings was verified with <5% error. Communication rates of 64 kbit/s with an error rate of 0.05% were shown, with no meaningful throughput degradation observed. Time to recharge to 80% capacity was <9 minutes. Two DBS systems also were implanted in the second test animal, and independent bilateral stimulation was successfully shown.
CONCLUSIONS: The system performed at clinically relevant implant depths and settings. Independent bilateral stimulation for the duration of the study with a 4F energy storage and full rapid recharge were achieved. Continuous function extrapolates to six days of continuous stimulation in future design iterations implementing application specific integrated circuit level efficiency and 15F storage capacitance. UsWB increases energy efficiency, reducing storage requirements and thereby enabling device miniaturization. The device can enable intelligent closed-loop stimulation, remote system monitoring, and optimization and can serve as a power/data gateway to interconnect the intrabody network with the Internet of Medical Things.
摘要：
目的：本研究旨在表明使用闭环节能的基于超声的机制进行通信的原型电神经调节系统的可行性，数据传输,和充电。
方法：使用超声宽带（UsWB）通信技术和小型化定制电子产品设计和制造了闭环深部脑刺激（DBS）原型。将两个装置短期植入麻醉的哥廷根小型猪(N=2)中。使用术前磁共振成像进行靶向，术后通过计算机断层扫描确认位置。DBS系统在广泛的刺激设置下进行了测试，以模拟最小，典型的,和/或积极的临床设置，并评估其通过头皮组织传输数据并使用UsWB为DBS系统充电的能力。
结果：刺激，通信,重新编程,并且在两个受试者的振幅（1V-6V）中成功实现了再充电方案，频率（50-250Hz），和脉冲宽度（60-200μs）设置并保持≥6小时。验证了脉冲设置的精度，误差<5％。通信速率为64kbit/s，出错率为0.05％，没有观察到有意义的吞吐量下降。再充电至80%容量的时间<9分钟。在第二只试验动物中还植入了两个DBS系统，并成功显示了独立的双侧刺激。
结论：该系统在临床相关的植入深度和设置下进行。在研究期间实现了具有4F能量存储和完全快速充电的独立双侧刺激。在未来的设计迭代中,连续函数外推至六天的连续刺激,实现专用集成电路级效率和15F存储电容。UsWB提高了能源效率，降低存储要求，从而使设备小型化。该设备可以实现智能闭环刺激，远程系统监控，和优化，可以作为电源/数据网关，将体内网络与医疗物联网互连。
方法：使用超声宽带（UsWB）通信技术和小型化定制电子产品设计和制造了闭环深部脑刺激（DBS）原型。将两个装置短期植入麻醉的哥廷根小型猪(N=2)中。使用术前磁共振成像进行靶向，术后通过计算机断层扫描确认位置。DBS系统在广泛的刺激设置下进行了测试，以模拟最小，典型的,和/或积极的临床设置，并评估其通过头皮组织传输数据并使用UsWB为DBS系统充电的能力。
结果：刺激，通信,重新编程,并且在两个受试者的振幅（1V-6V）中成功实现了再充电方案，频率（50-250Hz），和脉冲宽度（60-200μs）设置并保持≥6小时。验证了脉冲设置的精度，误差<5％。通信速率为64kbit/s，出错率为0.05％，没有观察到有意义的吞吐量下降。再充电至80%容量的时间<9分钟。在第二只试验动物中还植入了两个DBS系统，并成功显示了独立的双侧刺激。
结论：该系统在临床相关的植入深度和设置下进行。在研究期间实现了具有4F能量存储和完全快速充电的独立双侧刺激。在未来的设计迭代中,连续函数外推至六天的连续刺激,实现专用集成电路级效率和15F存储电容。UsWB提高了能源效率，降低存储要求，从而使设备小型化。该设备可以实现智能闭环刺激，远程系统监控，和优化，可以作为电源/数据网关，将体内网络与医疗物联网互连。
