Wearable Patch Reader for Peripheral Artery Disease

用于外周动脉疾病的可穿戴贴片读取器

• 批准号: 9202747
• 负责人: Natalie Ann Wisniewski
• 金额: $ 78.72万
• 依托单位: PROFUSA, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-03 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9202747
• 关键词: Achievement; Acute; Adherence; Adopted; Affect; Aftercare; Age; American; Amputation; Angioplasty; Appearance; Area; Arteries; Atherectomy; Atherosclerosis; Balloon Angioplasty; Bandage; Blood Vessels; Blood flow; Bypass; Caregivers; Chronic; Clinical; Clinical Research; Clinical Trials; Collaborations; Companions; Coronary Arteriosclerosis; Cutaneous; Data; Decision Making; Development; Devices; Diagnostic; Disease Progression; Economic Burden; Electronics; Ensure; Europe; Exercise; Film; Fluorescence; Fluoroscopy; Gangrene; Goals; Grant; Healed; Health; Healthcare; Human; Hydrogels; In Vitro; Individual; Injectable; Intermittent Claudication; Intervention; Interview; Ischemia; Lead; Life; Limb structure; Measurement; Measures; Methodology; Monitor; North America; Operative Surgical Procedures; Optical Readers; Optics; Outcome; Oxygen; Pain; Patient-Focused Outcomes; Patients; Performance; Peripheral arterial disease; Phase; Physicians; Predictive Value; Prevalence; Procedures; Quality of life; Rattus; Reader; Safety; Skin; Small Business Innovation Research Grant; Stents; Stream; Surgeon; Symptoms; System; Systems Integration; Technology; Testing; Therapeutic; Thick; Time; Tissues; Ulcer; Validation; Wireless Technology; abstracting; base; biomaterial compatibility; clinical practice; commercialization; cost; cytotoxicity; design; flexibility; foot; healing; health economics; improved; in vitro testing; in vivo; instrumentation; irritation; limb amputation; mHealth; minimally invasive; mortality; novel; point of care; prototype; radiologist; research and development; response; restenosis; safety testing; sensor; tool; usability

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.

抽象的 第二阶段 SBIR 的目标是将 Profusa 笨重的有线光学读取器转变为可穿戴、灵活、 一次性绷带状形式，贴合足部，可连续监测组织氧含量 外周动脉疾病患者的血运重建和再狭窄是一种表现。 系统性动脉粥样硬化影响着美国 10-1200 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时疼痛）到重度 （伴有 CLI 和坏疽），并与高截肢率、死亡率和贫困率相关 通过适当的监测和治疗，可以阻止甚至疾病进展。 相反，但易于使用、准确的监测产品来指示何时需要改变治疗方法并不 存在一种微创、高灵敏度和稳定性的组织氧监测工具。 提供快速组织测量，非常适合即时监测和远程连续测量 PROFUSA 的氧传感技术可以通过提供测量值来帮助挽救四肢。 一种在治疗前、治疗期间和治疗后测量缺血肢体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进行适当的治疗。 灵活的贴片读取器的开发将允许连续无线监控，为危重患者提供帮助 此外，这项技术有潜力向医生、患者或其他护理人员实时提供数据。 变革性的，不仅对于 PAD，而且对于连续体内诊断和移动健康的广阔领域 在第二阶段 SBIR 资助中，我们建议首先将 Profusa 现有的光学读取器转换为一个监控器。 通过使用新颖的柔性薄膜重新设计组件，实现灵活的可穿戴格式（即光学贴片读取器） 然后，我们将在体外测试重新设计的柔性读取贴片。 最终进行临床研究，测试安全性、耐磨性（人为因素）和体内功能。