Waterproof Leadless Armband For Continuous Wireless Monitoring For Atrial Fibrillation

1个项目摘要/摘要 2(不超过30行文本) 3房颤是世界范围内最常见的持续性心律失常。虽然新的自动对焦 在过去的十年中出现了4种治疗策略，这是临床医生和 研究人员的特点是阵发性房颤，通常是短暂的，而且经常是无症状的。突发性 6如果可以检测到房颤，无症状房颤的比例将会越来越高。 7尽管如此沉默，但仍会造成重大的长期健康后果。因此，迫切需要 8开发一种廉价的设备，用于长期、连续的监测，包括准确的实时房颤 9检测算法，以降低我国的医疗成本。这样的装置不仅会增加 10在有症状的患者中进行检测，并允许更好地评估治疗效果，但可能成为 11广泛采用，足以冲走没有症状的人，如果再加上强有力的宣传运动。 12考虑到可穿戴设备的日益流行，我们使用无铅检测房颤的方法 13个可穿戴臂章和一款智能手机应用程序将为患者和医疗保健提供者提供 14在病人实际生活中的各种情况下监测房颤的机会。我们想做的是 15用户可以长期真正生活在其中的设备。因为我们的方法不涉及心电导联，所以它将是 16尽量不显眼，从而更好地被患者接受和使用。我们的可穿戴设备有 17有可能扰乱房颤医疗保健的传统提供。为了成功地实现这一目标 要实现这一目标，必须将四大关键技术支柱商业化。第一个是准确的自动对焦检测 19算法。第二种是一种可重复使用的、坚固耐用、灵活的电极材料，不会对皮肤造成刺激 20，在所有实际条件下长期使用。三是运动伪影的准确去除 21算法。第四种是无引线心电采集。前两项技术发展是 22由我公司首席技术官完成。我们的自动对焦算法已经被证明在多个对等点上是准确的- 23种经过审查的出版物，现在可以通过Scottcare公司的Holter监护仪进行商业购买。 我们还开发了新型防水、灵活、无凝胶、可重复使用的不会造成皮肤损伤的电极 25岁的愤怒。因此，这个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显示出巨大的希望。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房颤检测产品。设想中的产品 28有可能通过准确和更简洁地建立 29在高危人群中诊断房颤，从而为临床医生提供了预防昂贵的机会 30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.