Portable Brain Injury Biomarker Detection System with Integrated Microdialysis Pr

具有集成微透析功能的便携式脑损伤生物标志物检测系统

• 批准号: 8645220
• 负责人: Champak Das
• 金额: $ 53.26万
• 依托单位: SFC FLUIDICS, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-15 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8645220
• 关键词: Animals; Arkansas; Back; Biological Assay; Biological Markers; Brain; Brain Hypoxia-Ischemia; Brain Injuries; Calibration; Case Study; Cerebrum; Clinical; Clinical Trials; Code; Computer software; Critical Care; Detection; Development; Dextrans; Ensure; Enzyme-Linked Immunosorbent Assay; Evaluation; Extracellular Fluid; Failure; Feedback; Glucose; Glutamates; Government; Guidelines; Health; Hour; Immunoassay; In Vitro; Individual; Injection of therapeutic agent; Injury; Intervention; Legal patent; Life Cycle Stages; Medical Device; Medicine; Microdialysis; Modality; Modeling; Monitor; Nurses; Patient Monitoring; Patients; Performance; Persons; Phase; Proteins; Protocols documentation; Pump; Pyruvate; Quality of Care; Rattus; Reagent; Recovery; Regulation; Reporting; Running; Seizures; Shock; Side; Software Validation; System; Technology; Testing; Time; Traumatic Brain Injury; United States; Urea; Variant; Vasospasm; Work; base; clinically relevant; college; controlled cortical impact; design; dextran; graphical user interface; improved; in vivo; innovation; instrument; operation; pressure; prototype; public health relevance; response; sensor; small molecule; user-friendly; verification and validation

Portable Brain Injury Biomarker Detection System with Integrated Microdialysis Probe Project Summary: SFC Fluidics is developing a portable, fully-integrated and automated medical device for clinical monitoring of patients with severe brain injury. The instrument will allow for automated detection of several small molecule biomarkers, glucose, glutamate, lactate, pyruvate and urea, and a protein biomarker, S100B. These biomarkers are present in the extracellular fluid in the brain and continuous real-time monitoring of their concentration will provide important clues about adverse secondary insults like ischemia, hypoxia, seizure, vasospasm and more, and will help in critical care of patients in neuro-ICU. SFC Fluidics will use a suite of proven, patented technologies to develop the proposed instrument and make it ready for FDA approval and subsequent clinical trials in Phase III. SFC's innovative component technologies have been tested and assembled into an initial prototype, whose basic functionality has been demonstrated during Phase I. During Phase II, SFC will systematically and iteratively improve the design and functionality of the existing prototype, conduct extensive side-by-side, in vitro and in vivo testing and validate performance in an established rat model. The targeted instrument will integrate many clinically relevant and useful features to significantly change the modality of critical care of neurotrauma patients.

便携式脑损伤生物标志物检测系统 集成微渗析探头 项目总结： SFC Fluidics正在开发一种便携式、完全集成和自动化的医疗设备 重型颅脑损伤患者的临床监护。该仪器将允许自动 检测几种小分子生物标志物，葡萄糖、谷氨酸、乳酸、丙酮酸和尿素， 和蛋白质生物标记物S100B。这些生物标志物存在于细胞外液中 大脑和持续实时监测它们的浓度将提供重要线索 关于不利的二次侮辱，如缺血、缺氧、癫痫、血管痉挛等，并将 帮助神经ICU中的患者进行危重护理。SFC Fluidics将使用一套经过验证的、获得专利的 开发拟议的仪器并使其准备好供FDA批准的技术 第三阶段的后续临床试验。证监会的创新组件技术已 测试并组装成初始原型，其基本功能已演示 在第一阶段期间，证监会将在第二阶段期间系统地和迭代地改进设计和 现有原型的功能性，进行广泛的并排、体外和体内测试 并在已建立的大鼠模型中验证性能。目标仪器将集成 许多临床相关和有用的特征将显著改变重症监护的方式 神经创伤患者。