Wearable Patch Reader for Peripheral Artery Disease

摘要 这项第二阶段SBIR的目标是将普罗富萨笨重的有线光学阅读器转变为可穿戴、灵活、 一次性、绷带状的形式，符合脚部，用于持续监测组织氧气水平 在外周动脉疾病患者的血管重建和再狭窄过程中。PAD是一种表现 系统性动脉粥样硬化在美国影响着1,000-1,200万人，患病率随着年龄的增长而增加。 PAD的范围从轻度(伴有间歇性跛行或运动疼痛)到重度 (伴有CLI和坏疽)，并与高截肢率、死亡率和贫困有关 生活质量。在适当的监测和治疗下，疾病的发展可以停止甚至 逆转，但易于使用，准确的监测产品，以指示何时需要改变治疗不 是存在的。一种组织氧监测工具，它是微创的，提供高灵敏度和稳定性，并可以 提供快速的组织测量，将是护理点监测和远程连续监测的理想选择 测量。PROFUSA的氧气传感技术可以通过提供 一种在治疗前、治疗中和治疗后实时测量缺血肢体组织氧水平的方法，从而 使适当的治疗能够在晚期症状出现之前及时实施。这个 灵活的贴片读取器的开发将允许连续的无线监测，为危重患者 将数据实时发送给医生、患者或其他护理人员。此外，这项技术有可能成为 变革性的，不仅对于PAD，而且对于持续的活体诊断和移动医疗的广泛领域 监控。在此第二阶段SBIR赠款中，我们建议首先将普罗富萨目前的光学阅读器转换为 灵活、可穿戴的格式(即光学贴片读取器)，通过使用新颖的柔性薄膜、 保形电子学。然后，我们将在体外测试重新设计的柔性贴片阅读器。最后，该项目将 最终在一项临床研究中达到顶峰，以测试安全性、佩戴性(人的因素)和体内功能。

Abstract The goal of this Phase II SBIR is to convert Profusa’s bulky, cabled, optical reader into a wearable, flexible, disposable, bandage-like format that conforms to the foot for continuous monitoring of tissue oxygen levels during revascularization and restenosis in patients with peripheral artery disease. PAD is a manifestation of systemic atherosclerosis that affects 10-12 million people in the U.S., with prevalence increasing with age. PAD ranges from mild (accompanied by intermittent claudication or pain with exercise) to severe (accompanied by CLI and gangrene), and is associated with high rates of amputation, mortality and poor quality of life. With the appropriate monitoring and treatment, disease progression can be halted and even reversed, but easy-to-use, accurate monitoring products to indicate when a change in therapy is needed do not exist. A tissue oxygen-monitoring tool that is minimally invasive, offers high sensitivity and stability, and could give rapid tissue measurements, would be ideal for point-of-care monitoring and remote continuous measurements. PROFUSA’s oxygen sensing technology can help salvage limbs from amputation by providing a way to measure real-time tissue oxygen levels in the ischemic limb before, during, and after treatment, thus enabling appropriate therapy to be administered in a timely fashion before advanced symptoms appear. The development of the flexible patch reader would allow for continuous wireless monitoring, giving critical patient data to doctors, patients, or other caregivers in real-time. Furthermore, this technology has the potential to be transformative, not just for PAD, but for the broad field of continuous in vivo diagnostics and mobile health monitoring. In this Phase II SBIR grant, we propose to first convert Profusa’s current optical reader into a flexible, wearable format (i.e. optical patch reader) through component redesign using novel flexible, thin-film, conformal electronics. We will then test the redesigned flexible patch reader in vitro. Lastly, the project will culminate in a clinical study to test safety, wearability (human factors) and in vivo functionality.