Wireless Multi-Modal Brain Monitoring

无线多模式脑部监测

• 批准号: 7886509
• 负责人: Bruce Lanning
• 金额: $ 52.69万
• 依托单位: ITN ENERGY SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2012-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7886509
• 关键词: Animals; Biocompatible Materials; Biocompatible Materials Testing; Bite; Brain; Collaborations; Communication; Computer software; Contractor; Data; Data Storage and Retrieval; Development; Devices; Electrodes; Electroencephalogram; Electroencephalography; Electronics; Epilepsy; Equipment; Frequencies; Functional Magnetic Resonance Imaging; Functional disorder; Funding; Goals; Human; Implant; Infection; Intractable Epilepsy; Invaded; Link; Magnetic Resonance Imaging; Manufacturer Name; Marketing; Measurement; Measures; Medical; Modality; Monitor; Neurosciences; Operative Surgical Procedures; Patients; Performance; Phase; Protocols documentation; Radio; Resolution; Risk; Rodent; Safety; Sampling; Seizures; Signal Transduction; Solutions; Stream; Structure; System; Technology; Testing; Time; Toxicity Tests; Traumatic Brain Injury; Universities; Wireless Technology; attenuation; biomaterial compatibility; commercialization; design; digital; direct application; electrical measurement; flexibility; improved; innovation; instrument; laptop; meetings; nanoscale; nervous system disorder; neurosurgery; operation; product development; programs; public health relevance; response; sensor; transmission process; wasting

DESCRIPTION (provided by applicant): Over the last two decades, there has been a growing need to record electrical signals directly from the brain in humans and animals, especially in candidate patients requiring resective epilepsy surgery. At the same time, there is an increasing demand for real-time monitoring of a larger number (>200 channels) and different types of electrodes and modalities to provide adequate spatial and temporal resolution for pathophysiology; a challenge that becomes self-limiting and intractable with current state of practice. ITN Energy Systems, in collaboration with Yale University Epilepsy Program and Ad-Tech Medical Instruments Corporation will bring their unique expertise in biocompatible materials and sensors, nanoscale electronics, neurosurgery, neuroscience, and manufacturing, marketing and commercialization of brain implantable electrodes to develop an enabling wireless, multi-channel intracranial electroencephalogram (icEEG) implantable system/device. In the Phase I effort, we were able to successfully design and fabricate an implantable icEEG measurement and recording device. Successful operation of the device was validated as a free-standing system and then subsequently implanted in three rodents. The implanted monitoring system measured and recorded icEEG signals over the course of several days, including successful demonstration of remote powering using a radio frequency (RF) inductive link and the wireless transmission of icEEG data with a high bandwidth infrared communications link. The goal of the Phase II project will be to expand the Phase I 5-channel system for rodents into a 64-channel system with continuous icEEG recording (0.1 to 500 Hz at a 1 KS/sec sampling rate) for direct application in humans. In particular, we will 1) Optimize the current inductive RF link (13.56 MHz) and power management circuit design to reduce the footprint of the implant antenna, insure MRI safe operation, and incorporate the option of on-board power storage feature (battery and/or capacitor) for continuous uninterruptible operation, 2) Improve and expand the existing infrared link by developing and implementing software to support an IrDA protocol, 3) Reduce overall footprint by 30% using die level components on a lightweight substrate, 4) Conduct extensive biocompatibility and toxicity testing for short and long term applications, and 5) Conduct thorough rodent tests, using expanded 4 by 8 and/or 8 by 8 electrode grid arrays to optimize performance and robustness of the device. Successful completion of Phase II will validate critical building blocks of a multimodal implantable icEEG system that is inherently expandable to meet the growing needs for hundreds of measurement channels. These advances move the device towards use in patients and subsequent product development and commercialization. PUBLIC HEALTH RELEVANCE: This project proposes the design and testing of a wireless, 64-channel implantable system for the continuous recording of icEEG signals from the brain. Such a wireless system will not only eliminate tethering of patients to EEG equipment but expand the number of channels surrounding the seizure onset region in medically intractable epilepsy patients requiring surgery, monitoring of brain trauma, and the understanding of other neurological disorders. The proposed implantable technology will facilitate the direct access of electrical activity within the brain via wireless transmission of a high resolution, digital data stream that links directly into a portable laptop or waste-worn data storage system.

描述（由申请人提供）： 在过去的二十年中，人们越来越需要直接从人类和动物的大脑中记录电信号，尤其是在需要恢复癫痫手术的候选患者中。同时，对更大数量（> 200个通道）的实时监测以及不同类型的电极和方式的需求增加，以提供足够的空间和时间分辨率来用于病理生理学；在当前的实践状态下，这一挑战成为自我限制和棘手的挑战。 ITN能源系统与耶鲁大学癫痫计划和AD-Tech医疗器械合作将带来其在生物相容性材料和传感器方面的独特专业知识，纳米级电子，神经外科手术，神经科学，神经科学以及脑植入式电极的营销和商业化，以开发无线，冰心型冰心式（冰）的无线设备。在第一阶段的工作中，我们能够成功设计和制造可植入的ICEEG测量和记录设备。该设备的成功操作被证实为独立系统，然后植入三个啮齿动物。在几天的时间内测量并记录了ICEEG信号的植入监测系统，包括使用射频（RF）电感链路成功演示远程电源，以及具有高带宽红外通信链接的ICEEG数据的无线传输。第二阶段项目的目标是将啮齿动物的I阶段5通道系统扩展到一个64通道系统中，该系统具有连续的ICEEG记录（0.1至500 Hz，以1 ks/sec的采样速率）直接在人类中进行直接应用。特别是，我们将1）优化当前的电感RF链接（13.56 MHz）和电源管理电路设计，以减少植入天线的足迹，确保MRI安全操作，并合并在板上电源存储功能（电池和/或电容器）的选项（电池和/或电容器），以通过连续不间断的操作来改善和扩展现有的INSPORTION，2）将IRF置于30％的链接，2）轻量级基材上的模水平分量，4）使用扩展的4 x 4 x 8 x 8和8 x 8 x 8 x电极网格阵列来优化设备的性能和稳健性，对短期和长期应用进行广泛的生物相容性和毒性测试，以及5）进行彻底的啮齿动物测试。成功完成II期将验证多模式植入式ICEEG系统的关键构建块，该系统本质上可以扩展，以满足数百个测量通道的不断增长的需求。这些进步使该设备用于患者以及随后的产品开发和商业化。公共卫生相关性：该项目提出了无线，64通道可植入系统的设计和测试，以连续记录大脑的ICEEG信号。这种无线系统不仅会消除患者到脑电图设备的束缚，而且会扩大需要手术，监测脑外伤的医学上顽固性癫痫患者中癫痫发作区域周围的渠道数量以及对其他神经系统疾病的理解。拟议的植入技术将通过无线传输高分辨率，数字数据流的无线传输来促进大脑内电活动的直接访问，该数据流直接连接到便携式笔记本电脑或废弃的数据存储系统中。