Implant Design and Development for Human Cortical Recording

描述(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传输到外部应用的关键瓶颈。这一领域的共识是，存在可用于控制假肢和恢复瘫痪肢体运动的皮质控制信号，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无线的、可扩展的128通道记录系统的开发，适合人类长期使用。应用范围从闭锁患者的通信，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第一阶段拨款，神经信号公司拥有实现这一目标所需的经验。第一阶段工作(1 R43 NS-42478-01)设计和制造了一个8通道、灵活的表面贴装组件，包括一个无线感应电源、内部校准、8个录音放大器和8个调频发射机。与我们以前的植入式录音系统相比，在这次赠款期间开发的混合电路使录音系统的体积减少了四倍。第二阶段第一批(1 R43 NS048706-01)刚刚完成。在这次授予期间，制造了一个16通道集成电路(1C)来放大来自皮质电极的信号，并使用模拟扫描仪对信号进行多路传输。第二阶段的具体目标是：a：继续开发集成电路器件，(1)在集成电路中加入电压调节和偏置电路，以最大限度地减少外部半导体元件；(2)根据在第一阶段开发中获得的知识，改进浮栅记录放大器和扫描仪；(3)继续开发(A)功率感应系统和(B)将取代现有FM系统的独特的同步扫描仪传输系统。B：将神经营养电极连接小型化，以便与1C设备可靠连接。C：选择和实施新的涂层，并对由记录放大器、电源、无线信号传输和连接的电极组成的植入式记录设备进行浸泡测试和应力测试。

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.