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现象的关键部件。目前，将电极放置在头皮上是有问题的、耗时且费力的。作为先前 NIH SBIR 计划的一部分，与 Baltimore Biomedical, Inc. 合作开发了一种新型自装电极技术并获得专利，该技术使用头发将电极固定在头皮附近。基于此现有技术，Key Technologies, Inc. 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（例如脑电图实验室、睡眠中心以及动态监测、游戏和重症监护等不断增长的市场）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 的验证。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等于金杯标准。这种设计独特地提供了通过单个手持式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过量的电解质。尺寸小、舒适度高和快速放置特性使该系统非常适合需要多个电极的重症监护、脑电图、麻醉和扩展监测。与当前的行业标准不同，电极将是一次性的，这是当前控制传染病传播的理想属性。第三阶段的项目目标是设计、原型制作、验证、营销、制造和商业化这种新型电极系统。迄今为止，初步原型设计已完成并通过一期临床试验验证。第二阶段将重点关注以下任务：改进机械设计、开发定制电解质以增强长期性能、改进工具设计以整合多个电极，以及彻底的临床试验以证明在广泛的人口统计范围内的性能。