Development of a Practical Non-contact ECG Sensor for Arrhythmia Diagnosis

描述(申请人提供)：数以百万计的人受到心律失常的影响，其中一些会导致良性症状，另一些会危及生命。获得症状与节律的相关性对于提供适当的治疗至关重要。虽然心律失常检测的基本原理和技术已经广为人知，但这种疾病的暂时性、不可预见性和通常无症状的性质仍然使有效的心律失常检测成为问题。与患者依从性和患者舒适度相关的问题使长期的心电监测成为问题，尽管这项技术简单而廉价。最可靠的监测技术仍然需要侵入性的植入式设备。随着廉价、复杂的移动和无线电子设备的广泛使用，真正实现对患者友好的心电监测系统的唯一真正障碍是电极/传感器层面。这项提议将开发出第一个实用的非接触式心电传感器，具有通过服装获取高质量信号的能力。尽管在世界各地的研究实验室中有许多其他非接触式传感器设计，但仍然没有真正用于临床的产品。与成本、复杂性、运动伪影和噪声相关的悬而未决的问题尚未得到充分解决。也有干燥和半干燥传感器，但它们需要与皮肤接触，这会带来各种问题。该项目代表了第一个高质量的穿透式心电传感器。核心技术基于该领域的一种全新方法，首先是由加州大学圣地亚哥分校PI开发的定制集成电路。在初步测试中，这种新设计实现了远远优于以前使用的现成组件的性能。Cognionics已授权将这项技术商业化，将其与新的机械组件相结合，这些组件在保持高水平患者舒适度的同时，极大地抑制了运动伪影的影响。我们相信这一点 技术将最终实现非接触式传感器的承诺，从而彻底改变心电的获取方式。第一阶段项目将以系统的临床测试结束，以充分了解所有性能优势、能力、限制及其临床意义。 公共卫生相关性：数百万人受到心律失常的影响，心律失常是潜在威胁生命的疾病的指标，每年直接导致约50万人死亡。心律失常的检测通常需要家庭心电监护，但目前的移动式心电图仪存在患者舒适度、便利性和依从性差的问题，降低了疗效。该SBIR项目旨在开发一种高质量的非接触式、穿透式心电传感器，有可能改变心脏监测的方式。

DESCRIPTION (provided by applicant): Millions of people are affected by cardiac arrhythmias, some of which result in benign symptoms and others are life-threatening. Obtaining symptom-rhythm correlation is paramount to providing appropriate therapy. While basic principles and techniques for arrhythmia detection are well-understood, the transient, unpredictable, and often asymptomatic nature of the disorder still make effective arrhythmia detection problematic. Issues relating to patient compliance and patient comfort make long-term ECG monitoring problematic, despite the simple and inexpensive nature of the technology. The most reliable monitoring techniques still require invasive implantable devices. With the widespread availability of inexpensive, sophisticated mobile and wireless electronics, the only real remaining barrier towards truly patient-friendly ECG monitoring systems is at the electrode/sensor-level. This proposal will develop the first practical non-contact, ECG sensor with the capability of acquiring high- quality signals through clothing. Although there are many other non-contact sensor designs in research labs around there world, there is still no real product for clinical use. Unresolved issues relating to cost, complexity, movement artifacts and noise have yet to be adequately solved. There are also dry and semi-dry sensors but they require contact with the skin, which presents a variety of problems. This project represents the first high quality, through-clothing ECG sensor. The core technology is based on a fundamentally fresh approach to the field, starting with a custom integrated circuit which developed by the PI at the University of California, San Diego. In preliminary testing, this new design has enabled far superior performance to what was possible with the off-the-shelf components used in previous efforts. Cognionics has licensed this technology for commercialization, combining it with new mechanical assemblies that greatly dampen the effects of motion artifacts while maintaining a high-level of patient comfort. We believe that this technology will finally realize the promises of non-contact sensors toward revolutionizing the way ECGs are taken. The Phase I project will conclude with a systematic clinical testing to fully understand all the performance advantages, capabilities, limitations and their clinical implications. PUBLIC HEALTH RELEVANCE: Millions of people are affected by cardiac arrhythmias, which are indicators of potentially life-threatening diseases, and directly lead to approximately half a million deaths each year. Detection of arrhythmia commonly requires home ECG monitoring due to the infrequency of the symptoms, yet current mobile ECG instruments suffer from poor patient comfort, convenience and compliance, reducing their efficacy. This SBIR project aims to develop a high-quality non-contact, through-clothing ECG sensor with the potential to change the way cardiac monitoring is performed.