Waterproof Leadless Armband For Continuous Wireless Monitoring For Atrial Fibrillation

1项目概要/摘要 2（不超过30行文字） 3心房颤动（AF）是世界范围内最常见的持续性心律失常。虽然新AF 过去十年出现了4种治疗策略，这是临床医生面临的一个重大挑战， 研究人员指出，房颤具有阵发性、通常短暂且经常无症状的性质。 6和无症状房颤将发现在越来越多的比例，我们的人口，如果它是检测， 7导致重大的长期健康后果，尽管如此沉默。因此，迫切需要 8.开发一种廉价的设备，用于长期连续监测，其中包含准确的实时AF 9检测算法，以降低我们国家的医疗费用。这样的设备不仅会增加 10检测有症状的患者，并允许更好地评价治疗效果，但可能成为 如果再加上强有力的宣传活动，11种方法被广泛采用，足以清除无症状的人。 12鉴于可穿戴设备的日益普及，我们使用无引线的AF检测方法 13个可穿戴臂章和一个智能手机应用程序将为患者和医疗保健提供者提供 在患者的真实的生活中的各种条件下监测AF的机会。我们想让 15、用户可以真正长期生活在其中的设备。因为我们的方法不涉及ECG导联， 16最低限度地突出，从而导致患者更好地接受和使用。我们的可穿戴设备 17破坏传统AF医疗服务的潜力。为了实现这一目标 18实现，四个关键技术支柱必须商业化。首先是准确的AF检测 19算法。第二种是可重复使用的、坚固耐用的柔性电极材料，不会引起皮肤刺激 20在所有现实世界条件下长期使用。三是精准的运动伪影去除 21算法。第四种是无引线ECG捕获。前两项技术发展是 22、我们公司的CTO。我们的自动对焦算法已被证明是准确的，在多个同行- 23篇综述性出版物，目前已在Scottcare Corporation的霍尔特监测仪中上市。 24我们还开发了新型防水、柔性、无凝胶、可重复使用的电极， 25刺激因此，SBIR项目的目标是使最后两个支柱技术成熟。 26.关于这两个概念的初步工作大有希望。我们相信这项工作将导致快速 27在后期阶段转化为创新和颠覆性的AF检测产品。设想的产品 28有可能通过准确和更简洁地建立 在高危人群中诊断房颤，从而为临床医生提供了一个机会，以防止昂贵的 30例这些危及生命的心律失常的继发性并发症。

1 PROJECT SUMMARY/ABSTRACT 2 (No longer than 30 lines of text) 3 Atrial Fibrillation (AF) is the most common sustained dysrhythmia worldwide. Although new AF 4 treatment strategies have emerged over the last decade, a major challenge facing clinicians and 5 researchers is the paroxysmal, often short-lived, and frequently asymptomatic nature of AF. Paroxysmal 6 and asymptomatic AF would be found in a growing percentage of our population if it were detectable, and 7 causes major long-term health consequences despite being so silent. There is, therefore, a pressing need to 8 develop an inexpensive device for long-term, continuous monitoring containing an accurate real-time AF 9 detection algorithm, to lower our nation's healthcare costs. Such a device would not only increase rates of 10 detection in symptomatic patients and allow for better evaluation of treatment efficacy, but could become 11 widely-adopted enough to flush out asymptomatic people, if coupled with a strong awareness campaign. 12 Given the ever-growing popularity of wearable devices, our approach to AF detection using leadless 13 wearable armbands and a smartphone app will give patients as well as health care providers the 14 opportunity to monitor for AF under the wide variety of conditions in a patient's real life. We want to make 15 a device the user can truly live in, long term. Because our approach does not involve ECG leads, it will be 16 minimally obtrusive, thereby leading to better acceptance and use by patients. Our wearable device has 17 the potential to disrupt the traditional delivery of AF healthcare. For this objective to be successfully 18 achieved, four key technology pillars must be commercialized. The first is an accurate AF detection 19 algorithm. The second is a reusable, rugged, flexible electrode material that does not cause skin irritation 20 with prolonged use in all real-world conditions. The third is an accurate motion artifact removal 21 algorithm. The fourth is leadless ECG capture. The first two technological developments have been 22 achieved by our company's CTO. Our AF algorithm has been shown to be accurate in multiple peer- 23 reviewed publications, and is now commercially available in a Holter monitor from Scottcare Corporation. 24 We have also developed novel waterproof, flexible, gel-less, reusable electrodes that do not cause skin 25 irritation. Hence, the objective of this SBIR project is to bring to maturity the last two pillar technologies. 26 Preliminary work on concepts for both show great promise. We believe this work will result in rapid 27 translation in later Phases into an innovative and disruptive AF detection product. The envisioned product 28 has the potential to significantly reduce healthcare costs by accurately and more succinctly establishing the 29 diagnosis of AF in at-risk groups, thereby providing clinicians with an opportunity to prevent expensive 30 secondary complications of these life-threatening arrhythmias.