Novel patient interface monitor for PSG/CPAP titration

用于 PSG/CPAP 滴定的新型患者界面监视器

• 批准号: 6482623
• 负责人: William A Hudgins
• 金额: $ 45.06万
• 依托单位: ELECTROSONICS MEDICAL INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-05-03 至 2004-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6482623
• 关键词: Internet; biomedical equipment development; clinical research; computer system design /evaluation; electrocardiography; electroencephalography; electrooculography; human subject; miniature biomedical equipment; patient monitoring device; polysomnography; portable biomedical equipment; respiratory therapy; sleep apnea

DESCRIPTION (provided by applicant): The long-term goal of this SBIR is to develop an improved full PSG / CPAP titration device for the home and the lab. Despite numerous improvements in data manipulation and analysis, the patient interface responsible for the critical role of generating the inputs has received little attention and remains unoptimal. Current PSG and CPAP titration patient interfaces use sensors and conventional electrode assemblies that are too busy, cumbersome to wear and generate indirect or noisy data. The proposed device will improve signal sensitivity, patient comfort and reliability by developing a new dedicated patient interface. The proposed device will incorporate three innovative features: I) miniaturized 23 channel headwom amplifier system for EEG/EOG, 2) non-contacting upper airway microsensors that plug in-line with the air hose proximal to the mask, and 3) a small recorder unit with novel micro data storage medium and wireless data transmission capability. BIOMEC will capitalize on technologies being developed for other applications. Although the primary targeted market is the lab, in-home studies will also benefit from such a device. Compactness and wearability will make the proposed device the first in-home sleep disorders monitor with in-lab capabilities. In Phase I, we tested the feasibility of embedded microsensors, miniaturized wearable hardware and micro data storage. In Phase II, we will complete the hardware design by integrating all the components together, and conduct clinical studies on 12 patients. The final product promises to set the standard for a new class of full PSG and CPAP titration for the lab and home. PROPOSED COMMERCIAL APPLICATION: The proposed device will have the capability of in-lab PSG devices but with the mobility and ease of use of home devices. The commercial potential include lab and home screening and monitoring of sleep disorders such as OSA, and isomnia. The total number of sleep labs is expected to exceed 2500 in the US alone. The total market for sleep diagnostic products is estimated at $104 million and is growing at 8% annually. One of the biggest drivers is the untapped OSA population, which is estimated at over 11 million. there is a huge need for improved diagnostic devices that generate sensitive recordings in a more comfortable patient interface. Also, a more compact and reliable patient interface will permit home use, which is one of the high growth market segments due to lower cost and more convenient procedure setting.

描述（由申请人提供）：本 SBIR 的长期目标是 开发适用于家庭和实验室的改进型全 PSG / CPAP 滴定装置。 尽管数据处理和分析方面取得了许多进步，但患者 负责生成输入的关键角色的接口 很少受到关注并且仍然不理想。当前 PSG 和 CPAP 滴定 患者界面使用传感器和传统电极组件 太繁忙、太麻烦，无法佩戴并生成间接或嘈杂的数据。拟议的 设备将通过以下方式提高信号灵敏度、患者舒适度和可靠性 开发新的专用患者界面。拟议的设备将 包含三个创新功能： I) 小型化 23 通道 headwom EEG/EOG 放大器系统，2) 非接触式上呼吸道微传感器 与面罩附近的空气软管对齐，以及 3) 一个小型记录器 具有新型微型数据存储介质和无线数据传输的单元 能力。 BIOMEC 将利用正在为其他领域开发的技术 应用程序。尽管主要目标市场是实验室，但家庭研究 也将受益于这样的设备。紧凑性和耐磨性将使 提议的设备是第一个在实验室内进行家庭睡眠障碍监测的设备 能力。在第一阶段，我们测试了嵌入式微传感器的可行性， 小型化可穿戴硬件和微数据存储。在第二阶段，我们将 通过将所有组件集成在一起来完成硬件设计，以及 对12名患者进行临床研究。最终产品有望设定 适用于实验室和家庭的新型全 PSG 和 CPAP 滴定标准。 拟议的商业应用： 所提议的设备将具有实验室 PSG 设备的功能，但具有家庭设备的移动性和易用性。 商业潜力包括实验室和家庭筛查以及睡眠障碍（例如 OSA 和失眠）的监测。 仅在美国，睡眠实验室的总数预计就会超过 2500 个。 睡眠诊断产品的总市场估计为 1.04 亿美元，并且每年以 8% 的速度增长。 最大的驱动因素之一是尚未开发的 OSA 人口，估计超过 1100 万。 迫切需要改进的诊断设备，以便在更舒适的患者界面中生成敏感的记录。 此外，更紧凑、更可靠的患者界面将允许家庭使用，由于成本更低和程序设置更方便，家庭使用成为高增长的细分市场之一。