Advanced Intraoperative Neuromonitoring System

先进的术中神经监测系统

• 批准号: 7482811
• 负责人: JAMES P O'HALLORAN
• 金额: $ 24.05万
• 依托单位: NEUROCOMP SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-19 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7482811
• 关键词: Address; Adhesives; Amplifiers; Anesthesia procedures; Architecture; Brain; Caring; Cephalic; Cerebrum; Clinical; Complement; Computer software; Consumption; Costs and Benefits; Development; Devices; Disease; Disruption; Documentation; Electrodes; Electroencephalogram; Electromagnetic Fields; Electromagnetics; Electronics; Electrostatics; Environment; Evoked Potentials; Excision; Frequencies; Goals; Immunity; Indium; Interruption; Intraoperative Monitoring; Malignant Neoplasms; Measurement; Measures; Methods; Metric; Monitor; Needles; Neurosurgical Procedures; Noise; Operating Rooms; Operative Surgical Procedures; Outcome; Patients; Performance; Peripheral; Peripheral Nerves; Phase; Physiologic pulse; Plant Roots; Postoperative Period; Power Sources; Preparation; Procedures; Production; Protocols documentation; Public Health; Pulse taking; Radio; Range; Recovery; Restart; Risk; Scalp structure; Sensory; Signal Transduction; Site; Somatosensory Evoked Potentials; Source; Spinal Cord; Staging; Standards of Weights and Measures; Surface; Surgeon; Synaptic Transmission; System; Techniques; Technology; Testing; Time; Universities; Wireless Technology; advanced system; analog; base; data acquisition; design; disability; electric impedance; human subject; improved; indexing; neurophysiology; notch protein; size; tumor; voltage

DESCRIPTION (provided by applicant): Cranial and peripheral biopotentials are routinely utilized to evaluate neurophysiologic integrity of both cranial and peripheral nerves during various surgical procedures. Intraoperative neurophysiological monitoring (IONM) provides outcome-sensitive, real-time metrics of neural transmission integrity, such as somatosensory evoked potential amplitude and latency. Such measures dynamically guide surgical procedures and reduce the risk of post-operative disabilities and complications. IONM has found widespread use in surgical interventions involving the brain and spinal cord for a range of disorders, including forms of cancer with CNS involvement. However, cerebral and peripheral biopotentials are very low level (down to sub-microvolt) signals that are highly susceptible to contamination by an array of electrically powered devices in the operating room (OR), such as the anesthesia machine, warming devices and especially, electrosurgical units (ESUs). Electromagnetic and electrostatic interference, both in the low frequency range (primarily 50-60 Hz) and radio frequency (RF) range limits and complicates signal acquisition and interpretation. In practice, the start of surgical procedures is often delayed and procedures can be interrupted due interference problems. ESU activation obliterates biopotential signal recordings. Interruption of evoked potential averaging sequences requires restart. Conventional methods of noise reduction, such as "notch" filtering for line frequency noise, are often ineffective and impose various compromises of signal integrity, such as amplitude reduction and phase-shifting due to proximity to the signal frequency range. "Baseline restore" techniques are useful in minimizing recovery time from ESU activation and other transients, but do not address the problem of signal loss at all. An advanced Intraoperative Neuromonitoring (aIONM) System is proposed that will achieve a very high level of immunity to both electrostatic and electromagnetic sources. Effectively, the aIONM system will reduce all forms of electrical interference in the OR environment to negligible levels, permitting uninterrupted recording of cerebral and peripheral biopotentials, even during ESU activation and without signal integrity compromise. The aIONM will introduce an analog electronic technology to IONM that enables noise-free biopotential signal acquisition in the presence of high and unbalanced electrode impedances for both cup and needle-type electrodes. Setup time for clinical and experimental protocols will be reduced to the time required to apply electrodes. It will eliminate scalp site preparation. Importantly, surgical procedures will not be delayed, interrupted or otherwise compromised due to interfernce in the OR. The aIONM will introduce a fundamentally newhardware architecture integrating acomplete,low power computerand LCD display. TheaIONM willprovide a full complement of monitoring and stimulation functions, replacing both portable and "workstation" intraoperative monitors. Multimodal wireless connectivity and other features will further extend its utility for comprehensive IONM. The specific goal of Phase I is to evaluate key system performance elements in both benchtop tests and intraoperatively in human subjects at two independent, university-based centers. PUBLIC HEALTH RELEVANCE The proposed system would find application in routine clinical and experimental acquisition of intraoperative biopotentials. The very high tolerance of the proposed Advanced Intraoperative Neuromonitoring System (aIONM) for high and unbalanced electrode impedances in electrically noisy operating room environments will substantially improve the ability to monitor critical neurophysiological functions during surgical procedures. The aIONM will eliminate intraoperative monitoring disruptions due to electrical noise and thus increase the level of care. Further, the IBMS will also achieve a much higher benefit:cost ratio than existing technologies.

描述（由申请人提供）： 在各种外科手术过程中，颅和外周生物电位通常用于评价颅和外周神经的神经生理完整性。术中神经生理监测（IONM）提供了神经传输完整性的结果敏感的实时指标，如体感诱发电位振幅和潜伏期。这些措施动态地指导外科手术，减少术后残疾和并发症的风险。IONM已被广泛用于涉及脑和脊髓的手术干预，用于一系列疾病，包括涉及CNS的癌症。然而，大脑和外周生物电位是非常低水平（低至亚微伏）的信号，其非常容易受到手术室（OR）中的电动设备阵列（诸如麻醉机、加温设备，尤其是电外科单元（ESU））的污染。低频范围（主要是50-60 Hz）和射频（RF）范围内的电磁和静电干扰限制了信号采集和解释，并使其复杂化。在实践中，外科手术的开始通常被延迟，并且手术可能由于干扰问题而中断。ESU激活消除了生物电位信号记录。诱发电位平均序列中断需要重启。传统的噪声降低方法，例如用于线路频率噪声的“陷波”滤波，通常是无效的，并且由于接近信号频率范围而强加信号完整性的各种折衷，例如幅度降低和相移。“基线恢复”技术在最小化从ESU激活和其他瞬变的恢复时间方面是有用的，但根本不能解决信号丢失的问题。提出了一种先进的术中神经监测（aIONM）系统，该系统将对静电和电磁源实现非常高的抗扰度。有效地，aIONM系统将把手术室环境中所有形式的电干扰降低到可忽略的水平，允许不间断地记录大脑和外周生物电位，即使在ESU激活期间也不影响信号完整性。aIONM将为IONM引入模拟电子技术，该技术可在杯形和针形电极存在高和不平衡电极阻抗的情况下实现无噪声生物电位信号采集。临床和实验方案的设置时间将减少到应用电极所需的时间。它将消除头皮部位准备。重要的是，手术不会因手术室的干扰而延迟、中断或以其他方式受到影响。aIONM将引入一种全新的硬件架构，将完整的低功耗计算机和LCD显示器集成在一起。IONM将提供完整的监测和刺激功能，取代便携式和“工作站”术中监测器。多模式无线连接和其他功能将进一步扩展其在综合IONM中的实用性。第一阶段的具体目标是在两个独立的大学中心的实验室试验和术中人体受试者中评价关键系统性能要素。 公共卫生相关性所提出的系统将在术中生物电位的常规临床和实验采集中找到应用。所申报的高级术中神经监测系统（aIONM）在电噪声手术室环境中对高和不平衡电极阻抗的极高耐受性将显著提高在外科手术期间监测关键神经生理功能的能力。aIONM将消除由于电噪声引起的术中监测中断，从而提高护理水平。此外，IBMS还将实现比现有技术高得多的效益成本比。