Implant Design and Development for Human Cortical Recording

描述（由申请人提供）：在皮层控制信号采集领域，记录系统是将内部信号传递到外部应用的关键瓶颈。在这一领域，人们一致认为，有皮层控制信号可用于控制假肢装置和恢复瘫痪肢体的运动，但这些信号必须被记录和快速完整地传输。我们的目标是完成一个无线的，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。使用两个最近完成的第一阶段赠款，神经信号有必要的经验，以满足这一目标。第一阶段的工作（1 R43 NS-42478-01）设计并制造了一个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FM发射机。与我们以前的植入式记录系统相比，在此资助期间开发的混合电路使记录系统的体积减少了四倍。第二个第一阶段赠款（1 R43 NS 048706 -01）刚刚完成。在此期间，一个16通道的集成电路（1C）被制造出来，以放大来自皮层电极的信号，并使用模拟扫描仪对信号进行多路复用。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纳入集成电路，以尽量减少外部半导体元件;（2）根据第一阶段开发期间获得的知识改进浮栅记录放大器和扫描器;（3）继续发展（a）电力感应系统和（B）一种独特的同步扫描传输系统，以取代目前的调频系统。B：微型化神经营养电极连接，以便与1C器械可靠连接。丙：选择并采用新涂层，并对由记录放大器、电源、无线信号传输和连接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.