Quick Placement EEG Electrode and Installation Tool

快速放置脑电图电极和安装工具

• 批准号: 6933291
• 负责人: BENJAMIN R LANE
• 金额: $ 37.11万
• 依托单位: KEY TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-15 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6933291
• 关键词: clinical research; clinical trials; consumable /disposable biomedical equipment; electrodes; electroencephalography; electrolytes; evaporation; human subject; mechanical stress; patient oriented research; technology /technique development

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.

描述（由申请人提供）：脑电图（EEG）电极是诊断和理解神经系统现象的关键组成部分。头皮上的电极放置目前是有问题的，耗时的，并且劳动量很大。与巴尔的摩生物医学公司合作，开发并获得了一种新型的自动安装电极技术，并作为先前的NIH SBIR计划的一部分获得了专利，并使用头发将电极固定在头皮附近。基于这项先前的艺术，Key Technologies，Inc。已构思和开发了一个专门支持多电极环境（例如脑电图实验室，睡眠中心以及不断增长的市场，例如门诊监测，游戏和重症监护）的电极放置系统。新系统由一次性电极和可重复使用的安装工具组成。该系统已通过现在完整的I阶段NIH SBIR证明。分析和定性分析表明，系统性能等于信号形状，振幅，光谱功率密度和人工制品密度的金杯标准。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，而无需凌乱的胶粘剂或多余的电解质。小尺寸，高舒适度和快速放置属性使系统的系统非常适合重症监护，脑电图，麻醉药和扩展监控，其中需要多个电极。与当前的行业标准不同，电极将是一次性的，这是当前关注的理想属性，以控制传染病的传播。通过第三阶段的项目目标是设计，原型，验证，市场，制造和商业化这种新型电极系统。迄今为止，通过I期临床试验完成了初步原型设计和验证。第二阶段将重点关注以下任务：对机械设计的完善，开发自定义电解质，以增强长期性能，工具设计的进步以结合多个电极，并进行了彻底的临床试验，以证明在广泛的人口统计学范围内表现性能。