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(申请人提供)：在各种外科手术中，脑神经和外周神经的神经生理学完整性通常被用来评估颅脑和外周的生物电位值。术中神经生理监测(IONM)提供对结果敏感的、实时的神经传递完整性指标，如体感诱发电位的幅度和潜伏期。这些措施动态地指导手术过程，减少手术后残疾和并发症的风险。IONM已被广泛用于涉及大脑和脊髓的一系列疾病的外科干预中，包括涉及中枢神经系统的各种形式的癌症。然而，大脑和外周生物电位点是极低水平(低至亚微伏)的信号，极易受到手术室(OR)中一系列电力设备的污染，如麻醉机、加温设备，特别是电外科单元(ESU)。电磁和静电干扰，在低频范围(主要是50-60赫兹)和射频(RF)范围内都有限制，使信号采集和解释变得复杂。在实践中，手术程序的开始通常会被推迟，而且由于干扰问题，程序可能会中断。ESU激活会消除生物势能信号记录。中断诱发电位平均序列需要重新开始。传统的降噪方法，例如针对线频噪声的“陷波”滤波，通常是无效的，并且会对信号完整性造成各种危害，例如由于接近信号频率范围而导致的幅度减小和相移。“基准恢复”技术在最大限度地减少ESU激活和其他瞬间的恢复时间方面很有用，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系统(AIONM)，它将实现对静电源和电磁源的非常高水平的免疫力。有效地，aIONM系统将把OR环境中的所有形式的电子干扰减少到可以忽略的水平，允许不间断地记录大脑和外周生物要素，即使在ESU激活期间也不会影响信号完整性。AIONM将向IONM引入一种模拟电子技术，在杯状和针状电极存在高且不平衡的电极阻抗的情况下，实现无噪声生物电势信号采集。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。它将省去头皮部位的准备工作。重要的是，外科手术不会因为干扰手术室而延误、中断或以其他方式受到影响。AIONM将引入一种从根本上整合完整、低功耗计算机和LCD显示器的新硬件体系结构。AIONM将提供全面的监测和刺激功能，取代便携式和“工作站”术中监护仪。多模无线连接和其他功能将进一步扩展其在综合IONM中的应用。第一阶段的具体目标是评估两个独立的大学中心的人类受试者在台式测试和术中的关键系统性能要素。公共卫生相关性建议的系统将应用于术中生物标本的常规临床和实验采集。拟议的先进术中神经监测系统(AIONM)在电噪声的手术室环境中对高和不平衡的电极阻抗具有极高的耐受性，将极大地提高在外科手术中监测关键神经生理功能的能力。AIONM将消除由于电噪声造成的术中监测中断，从而提高护理水平。此外，IBM还将实现比现有技术更高的效益：成本比。