Implant Design and Development for Human Cortical Recording

描述（由申请人提供）：在皮质控制信号采集领域，记录系统是内部信号向外部应用传递的关键瓶颈。在这一领域，人们一致认为存在皮层控制信号，可以用来控制假肢装置并恢复瘫痪肢体的运动，但这些信号必须被快速完整地记录和传输。我们的目标是完成一种适合人类长期使用的无线、可扩展的128通道录音系统的开发。应用范围从闭锁病人的通信，到残疾人的环境控制，再到脊髓损伤人群的运动恢复。利用最近完成的两项I期资助，Neural Signals拥有实现这一目标所需的经验。第一阶段工作（1 R43 NS-42478-01）设计并构建了一个8通道，灵活的表面安装组件，包括无线感应电源，内部校准，8个记录放大器和8个FM发射器。与我们以前的植入式记录系统相比，在此期间开发的混合电路使记录系统的体积减少了四倍。第二阶段I期授权（1 R43 NS048706-01）刚刚完成。在此期间，研究人员制作了一个16通道集成电路（1C）来放大来自皮质电极的信号，并使用模拟扫描仪将信号复用。第二阶段的具体目标是：A：继续开发集成电路器件，(1)将电压调节和偏置电路集成到集成电路中，以最大限度地减少外部半导体元件；(2)根据第一阶段开发中获得的知识，对浮门记录放大器和扫描仪进行改进；(3)继续发展(a)功率感应系统和(b)将取代现有调频系统的独特同步扫描传输系统。B：小型化神经营养电极连接，与1C设备可靠连接。C：选择并实施新涂层，对由录音放大器、电源、无线信号传输和所附电极组成的植入式录音装置进行浸渍测试和应力测试。

DESCRIPTION (provided by applicant): In the field of cortical control signal acquisition, the recording system is a critical bottleneck for the passage of internal signals to external applications. It is agreed in this field that there are cortical control signals that can be used to control prosthetic devices and restore movement to paralyzed limbs, but these signals must be recorded and transmitted rapidly and intact. It is our goal to complete the development of a wireless, scalable 128-channel recording system, suitable for long-term human use. Applications range from communication for locked-in patients, to environmental control for the disabled, to motion restoration for the spinal cord injury population. Using two recently completed Phase I grants, Neural Signals has the necessary experience to meet this goal. The first Phase I effort (1 R43 NS-42478-01) designed and built an 8-channel, flexible, surface mount assembly, including a wireless inductive power supply, internal calibration, eight recording amplifiers, and eight FM transmitters. The hybrid circuit developed during this grant resulted in a four-fold reduction in the recording system's volume, compared to our previous implantable recording system. The second Phase I grant (1 R43 NS048706-01) has just been completed. During this grant, a 16-channel integrated circuit (1C) was fabricated to amplify signals from cortical electrodes and multiplex the signals using an analog scanner. Specific aims in Phase II are: A: Continue development of the integrated circuit device, (1) by incorporating voltage regulation and bias circuitry into the integrated circuit to minimize external semiconductor components; (2) by improving the floating gate recording amplifier and scanner based on knowledge gained during the Phase I development; (3) by continuing to develop (a) the power induction system and (b) a unique synchronous scanner transmission system that will replace the present FM system. B: Miniaturize the Neurotrophic Electrode connections for reliable connection with the 1C device. C: Choose and implement new coatings and perform soak testing and stress testing of the implantable recording device consisting of the recording amplifiers, power supply, wireless signal transmission and attached electrodes.