Advanced Intraoperative Neuromonitoring System

描述（由申请人提供）：颅和外周生物电位在各种外科手术过程中被常规用于评估颅和外周神经的神经生理完整性。术中神经生理监测（IONM）提供结果敏感的、实时的神经传递完整性指标，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已发现广泛应用于涉及脑和脊髓的外科干预，以治疗一系列疾病，包括涉及中枢神经系统的各种癌症。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，极易受到手术室（OR）中一系列电力设备的污染，例如麻醉机、加热设备，特别是电外科设备（esu）。电磁和静电干扰，无论是在低频范围（主要是50-60赫兹）和射频（RF）范围限制和复杂的信号采集和解释。在实践中，外科手术的开始经常被推迟，手术可能因干扰问题而中断。ESU激活消除了生物电位信号记录。诱发电位平均序列的中断需要重新启动。传统的降噪方法，如线频噪声的“陷波”滤波，通常是无效的，并且由于接近信号频率范围而对信号完整性造成各种损害，例如幅度降低和相移。“基线恢复”技术可以最大限度地减少ESU激活和其他瞬态的恢复时间，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，该系统将实现对静电和电磁源的高水平免疫。实际上，aIONM系统可以将手术室环境中所有形式的电干扰降低到可以忽略不计的水平，即使在ESU激活期间也可以不间断地记录大脑和周围生物电位，并且不会损害信号完整性。aIONM将为IONM引入一种模拟电子技术，该技术可以在杯型和针状电极存在高且不平衡电极阻抗的情况下实现无噪声的生物电位信号采集。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。它将消除头皮部位的准备。重要的是，手术过程不会因手术室的干扰而延迟、中断或受到损害。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。aionm将提供完整的监测和刺激功能，取代便携式和“工作站”术中监护仪。多模态无线连接和其他功能将进一步扩展其综合IONM的实用性。第一阶段的具体目标是在两个独立的、以大学为基础的中心评估在台式测试和术中人体受试者的关键系统性能元素。该系统可用于常规临床和实验中术中生物电位的获取。所提出的先进术中神经监测系统（aIONM）在电噪声手术室环境中对高和不平衡电极阻抗的高耐受性将大大提高外科手术过程中监测关键神经生理功能的能力。aIONM将消除因电噪声造成的术中监测中断，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。

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.