Wearable Patch Reader for Peripheral Artery Disease

摘要 第二阶段SBIR的目标是将Profusa庞大的有线光学阅读器转换为可穿戴的，灵活的， 一次性绷带状形式，适合足部，用于连续监测组织氧水平 在外周动脉疾病患者的血运重建和再狭窄期间。PAD是一种 系统性动脉粥样硬化，在美国影响10-12百万人，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 （伴随CLI和坏疽），并与高截肢率，死亡率和贫困率相关。 生活质量通过适当的监测和治疗，可以阻止疾病进展，甚至 相反，但易于使用，准确的监测产品，以指示何时需要改变治疗， 存在.一种微创的组织氧监测工具，提供高灵敏度和稳定性，并且可以 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帮助挽救截肢肢体， 一种在治疗之前、期间和之后测量缺血肢体中的实时组织氧水平的方法， 从而能够在晚期症状出现之前及时给予适当的治疗。的 柔性贴片阅读器的开发将允许连续的无线监测， 数据实时提供给医生、患者或其他护理人员。此外，这项技术有可能成为 变革性的，不仅是PAD，而且是连续体内诊断和移动的健康的广泛领域 监测.在第二阶段SBIR赠款中，我们建议首先将Profusa目前的光学阅读器转换为 通过使用新颖的柔性的、薄膜的、 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 最终进行临床研究，以测试安全性、可穿戴性（人为因素）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.