Quick Placement EEG Electrode and Installation Tool

描述（由申请人提供）：脑电图（EEG）电极是诊断和理解神经现象的关键组成部分。电极放置在头皮上目前是有问题的，耗时，劳动密集。在与巴尔的摩生物医学公司的合作中，一种新型的自安装电极技术被开发出来并获得专利，作为先前NIH SBIR项目的一部分，该技术使用头发在头皮附近固定电极。基于这项现有技术，Key Technologies, Inc.已经构思并开发了一种电极放置系统，专门用于支持多电极环境（如脑电图实验室、睡眠中心和不断增长的市场，如动态监测、游戏和重症监护）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I期NIH SBIR得到证实。分析和定性分析表明，在信号形状、幅度、频谱功率密度和伪影密度方面，系统性能等于金杯标准。这种设计独特地提供了通过单个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质。该系统体积小，舒适度高，放置快捷，非常适合重症监护、脑电图、麻醉和需要多个电极的扩展监测。与目前的行业标准不同，这种电极将是一次性的，这是控制传染病传播的理想属性。该项目的目标，通过第三阶段，是设计，原型，验证，市场，制造和商业化这种新型电极系统。到目前为止，初步的原型设计已经完成，并通过I期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，开发定制电解质以提高长期性能，改进工具设计以结合多个电极，并进行全面的临床试验以证明其在广泛人群中的性能。

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.