Real-Time Oxygen Monitoring for Tissue Health: Peripheral Artery Disease Application

实时氧气监测组织健康：外周动脉疾病应用

• 批准号: 9327034
• 负责人: Scott Nichols
• 金额: $ 76.7万
• 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: 2016-09-01 至 2019-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9327034
• 关键词: Academic Medical Centers; Affect; Aftercare; Age; American; Amputation; Angiography; Animal Disease Models; Animals; Arteries; Asthma; Atherosclerosis; Biochemical; Blood Vessels; Blood flow; Blood specimen; Businesses; Bypass; Calibration; Caring; Cellular Phone; Chronic Obstructive Airway Disease; Clinical; Clinical Research; Compartment syndromes; Custom; Data; Decision Making; Disease; Disease Progression; Disease model; Early Intervention; Economic Burden; Ensure; Equipment; Exercise; Family suidae; Fiber Optics; Fibrinolytic Agents; Fluorescence; Fluoroscopy; Funding; Gangrene; Goals; Grant; Health; Healthcare; Hindlimb; Home environment; Human; Human Resources; Hydrogels; In Vitro; Injectable; Intermittent Claudication; Intervention; Ischemia; Lasers; Lead; Leg; Ligation; Limb Salvage; Limb structure; Mammals; Measurement; Measures; Medical; Methods; Miniaturization; Modeling; Monitor; Operative Surgical Procedures; Optical Readers; Oxygen; Pain; Patients; Performance; Perfusion; Peripheral; Peripheral arterial disease; Pharmacotherapy; Phase; Physicians; Physiological; Postoperative Period; Prevalence; Procedures; Quality of life; Rattus; Reader; Reproducibility; Safety; Signal Transduction; Skin; Sleep Apnea Syndromes; Small Business Technology Transfer Research; Subcutaneous Tissue; System; Technology; Temperature; Therapeutic; Time; Tissues; Tourniquets; Transplantation; Treatment Cost; Visit; Wound Healing; base; chronic wound; clinical application; commercialization; contrast enhanced; cost; design; femoral artery; implant design; implanted sensor; improved; improved outcome; in vivo; indexing; limb amputation; microsensor; mortality; novel; pre-clinical; pressure; product development; prototype; public health relevance; response; restenosis; sensor; success; temporal measurement; wireless fidelity

 DESCRIPTION (provided by applicant): Continuous biochemical monitoring has the power to change currently accepted standards of care, shifting the emphasis from treating illness to maintaining health. Point-in-time snapshots of a patient's health can miss critical fluctuations or early warning signs that might warrant early interventions or changes in disease treatment and management. PROFUSA's sensor platform has the promise to transform healthcare by providing real-time data to physicians and patients without requiring blood samples, cumbersome equipment, or doctor visits. The goal of this Fast Track STTR is to apply PROFUSA's injectable microsensors for monitoring tissue health in peripheral artery disease (PAD). Continuous oxygen monitoring will be useful in the treatment and management of a variety of diseases, such as asthma, COPD, sleep apnea, compartment syndrome, transplant surgery, and PAD. PAD is a manifestation of systemic atherosclerosis that affects 8-12 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 critical limb ischemia and gangrene), and is associated with high rates of amputation, mortality and poor quality of life. With the appropriate treatment and monitoring, disease progression can be halted and even reversed. PROFUSA's long-term tissue monitors can be used to continuously monitor tissue oxygen levels and temperature in PAD patients during their daily activities and thus provide timely indications of changes in disease state (e.g. restenosis). In recently completed landmark studies, PROFUSA's prototype oxygen sensors were shown to function 13 months in healthy rats and 3 months in large, healthy mammals. In this Fast Track STTR, we propose to demonstrate sensor functionality in PAD animal models: rats in Phase I and pigs in Phase II. Changes in tissue oxygen in the animals' healthy and ischemic legs will be monitored before, during, and after induction of PAD out to 90 days, a time period relevant to chronic wound healing, thrombolytic drug therapy optimization and monitoring for restenosis to avoid re-intervention and amputation. Phase II will also involve miniaturization of PROFUSA's custom optical reader system to improve the form factor for in vivo use. In addition to the strong scientific and pre-clinical team, medical, clinical, regulatory and business personnel will be an integral part of this project to provide early strategy for successful product development. The proposed studies will provide valuable data for advancing PROFUSA towards clinical studies of PAD monitoring and significant investor funding to enable commercialization for widespread clinical application.

 描述（由申请人提供）：连续生化监测有能力改变目前公认的护理标准，将重点从治疗疾病转移到维持健康，患者健康状况的时间点快照可能会错过关键的波动或。 可能需要早期干预或改变疾病治疗和管理的早期预警信号 PROFUSA 的传感器平台有望通过向医生和患者提供实时数据来改变医疗保健，而无需血液样本、繁琐的设备或医生就诊。该快速通道 STTR 旨在应用 PROFUSA 的可注射微传感器来监测外周动脉疾病 (PAD) 的组织健康状况，连续氧监测将有助于治疗和管理多种疾病，例如哮喘、慢性阻塞性肺病、睡眠。呼吸暂停、筋膜室综合征、移植手术和 PAD 是系统性动脉粥样硬化的一种表现，影响着美国 8-1200 万人，PAD 的患病率随着年龄的增长而增加，从轻度（伴有间歇性跛行或运动时疼痛）到不等。严重（伴有严重肢体缺血和坏疽），并与高截肢率、死亡率和生活质量差有关。 通过适当的治疗和监测，可以阻止甚至逆转疾病进展，PROFUSA 的长期组织监测仪可用于持续监测 PAD 患者在日常活动期间的组织氧水平和温度，从而及时提供疾病状态变化的指示。 （例如，再狭窄）。在最近完成的里程碑式研究中，PROFUSA 的原型氧传感器在健康大鼠中可运行 13 个月，在大型健康哺乳动物中可运行 3 个月。 PAD 动物模型中的传感器功能：在诱导 PAD 之前、期间和之后长达 90 天（相关时间段）的情况下，将监测第一阶段的大鼠和第二阶段的猪的健康腿部和缺血腿部的组织氧变化。除了对慢性伤口愈合、溶栓药物治疗优化和再狭窄监测以避免再次干预和截肢外，第二阶段还将涉及 PROFUSA 定制光学读取器系统的小型化，以改善体内使用的形状因素。强大的科学和临床前团队、医疗、临床、监管和业务人员将成为该项目不可或缺的一部分，为成功的产品开发提供早期策略。拟议的研究将为推进 PROFUSA 进行 PAD 监测和临床研究提供宝贵的数据。大量投资者资助，以实现广泛临床应用的商业化。

项目成果

Injectable Phosphorescence-based Oxygen Biosensors Identify Post Ischemic Reactive Hyperoxia.

可注射的磷光氧生物传感器可识别缺血后反应性高氧。

• 发表时间: 2017
• 影响因子: 4.6
• 作者: Chien, Jennifer S;Mohammed, Mahmoud;Eldik, Hysem;Ibrahim, Mohamed M;Martinez, Jeremy;Nichols, Scott P;Wisniewski, Natalie;Klitzman, Bruce
• 通讯作者: Klitzman, Bruce