Quick Placement EEG Electrode and Installation Tool

描述(申请人提供)：脑电(EEG)电极是诊断和理解神经现象的关键部件。目前，在头皮上放置电极是有问题的，既耗时又费力。与Baltimore Biomedical，Inc.合作，开发了一种新型的自安装电极技术，并获得了专利，作为先前NIH SBIR计划的一部分，该技术使用头发将电极固定在头皮附近。基于这项现有技术，Key Technologies，Inc.构思和开发了一种电极放置系统，专门用于支持多电极环境(如脑电实验室、睡眠中心和不断增长的市场，如流动监测、游戏和重症监护)中的研究。新系统由一次性电极和可重复使用的安装工具组成。该系统已通过现已完成的第一阶段NIH SBIR进行了验证。分析和定性分析表明，系统性能在信号形状、幅度、频谱功率密度和伪影密度方面与金杯标准相当。这种设计独特地提供了通过单一的手持安装工具快速放置多个电极的能力，而不需要杂乱的粘合剂或多余的电解液。该系统体积小、舒适度高、放置迅速，是重症监护、脑电、麻醉药和需要多个电极的扩展监测的理想选择。与目前的行业标准不同，电极将是一次性的，这是目前人们关注的控制传染病传播的理想属性。通过第三阶段，项目目标是设计、原型、验证、营销、制造这种新型电极系统，并将其商业化。到目前为止，初步的原型设计已经完成，并通过第一阶段临床试验进行了验证。第二阶段将专注于以下任务：改进机械设计，开发定制电解液以提高长期性能，改进工具设计以结合多个电极，以及全面的临床试验，以证明在广泛的人口统计范围内的性能。

DESCRIPTION (provided by applicant): The electroencephalogram (EEG) electrode is a critical component for diagnosing and understanding neurological phenomenon. Electrode placement on the scalp is currently problematic, time consuming, and labor intensive. In partnership with Baltimore Biomedical, Inc., a novel self-installed electrode technology was developed and patented as part of a prior NIH SBIR program and uses hair to anchor the electrode near the scalp. Based on this prior art, Key Technologies, Inc. has conceived and developed an electrode placement system specifically to support studies in multi-electrode environments (such as EEG laboratories, sleep centers, and growing markets such as ambulatory monitoring, gaming, and critical care). The new system consists of a disposable electrode and a reusable installation tool. This system has been proven through a now complete Phase I NIH SBIR. Analytical and qualitative analyses have shown system performance to be equal to the gold cup standard in signal shape, amplitude, spectral power density, and artifact density. This design uniquely provides the ability for quick placement of multiple electrodes via a single, hand-held installation tool without the need for messy adhesives or excess electrolyte. The small size, high comfort level, and quick placement attributes make the system ideal for critical care, EEG, anesthetics, and extended monitoring in which multiple electrodes are required. Unlike the current industry standard, the electrode will be disposable, a desirable attribute with the current concern to control the spread of communicable diseases. The project goals, through Phase III, are to design, prototype, validate, market, manufacture, and commercialize this novel electrode system. To date, preliminary prototype designs have been completed and validated through Phase I clinical trials. Phase II will focus on the following tasks: refinement of the mechanical design, development of a custom electrolyte to enhance long term performance, advancement of the tool design to incorporate multiple electrodes, and thorough clinical trials to prove performance across a broad demographic spectrum.