Portable automated device for rapid venous blood draws and point of care diagnostic analysis

用于快速静脉抽血和护理点诊断分析的便携式自动化设备

• 批准号: 9145737
• 负责人: Martin L Yarmush
• 金额: $ 69.63万
• 依托单位: RUTGERS, THE STATE UNIV OF N.J.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-20 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9145737
• 关键词: Accident and Emergency department; Accounting; Address; Adult; Ambulatory Care; Area; Bedside Testings; Biological Assay; Blood; Blood Cells; Blood Circulation; Blood Platelets; Blood Tests; Blood Volume; Blood capillaries; Blood specimen; Cardiac; Caring; Cells; Childhood; Clinical; Collaborations; Collection; Computer software; Coupled; Cytometry; Detection; Development; Devices; Diagnostic; Discipline; Elderly; Electronics; Elements; Emergency Care; Emergency Medicine; Emergency Situation; Engineering; Ensure; Flow Cytometry; Glass; Goals; Health; Hematology; Hospitals; Human; Image; Immunoassay; Immunochemistry; In Vitro; Infant; Laboratories; Life; Liquid substance; Manuals; Measurement; Medical; Medicine; Methods; Microfabrication; Microfluidic Microchips; Microfluidics; Military Personnel; Needles; Neonatal; Optics; Outcome; Outpatients; Patient Care; Patients; Plasma Proteins; Procedures; Process; Protein Analysis; Proteins; Pump; Quality of Care; Reagent; Recording of previous events; Research; Resources; Robot; Robotics; Safety; Sampling; Site; Specimen; Stream; Supervision; System; Techniques; Technology; Test Result; Testing; Time; Translating; Translations; Troponin; United States; University Hospitals; Validation; Veins; Venipunctures; Venous; Venous blood sampling; Whole Blood; Wood material; base; blood fractionation; cost; design; diagnostic accuracy; engineering design; health care delivery; image guided; imaging platform; instrument; interest; optical imaging; point of care; point-of-care diagnostics; programs; prototype; research clinical testing; response; sample collection

 DESCRIPTION: Diagnostic blood testing is the most ubiquitous clinical procedure in the US, with over 1 billion tests performed annually. The traditional method of blood testing involves performing a venipuncture, transporting samples to a centralized lab, analyzing the samples using large benchtop instruments, and relaying the results to the clinician. This is a labor intensive, time consuming, and expensive process, and unexpected delays often arise due either to difficulties in performing the venipuncture or the time needed to transport and analyze the sample. Particularly in the hospital emergency department (ED), rapid changes in a patient's condition necessitate immediate response, and thus delays can be life threatening. Point of care (PoC) blood testing has emerged as a way to potentially reduce turnaround times, and several devices based on capillary blood draws have achieved commercial translation. However, in comparison to centralized testing, the quantity of available assays remains limited for existing PoC testing, and the accuracy of results obtained with capillary blood remains controversial. Venous blood draws via a venipuncture allows for the collection of a larger volume of blood, yielding more dependable results as the specimen comes directly from the circulation. However to date, no fully automated venous access devices are available, either as independent units, or coupled with POC testing platforms. To address these current limitations, our group is developing a portable, automated device that performs venipuncture and provides quantitative diagnostic results in 15 to 30 minutes at the point of patient care. The portable device will operate by imaging a patient's veins, autonomously introducing a needle into a selected vein, drawing blood into microfluidics chips, and performing on-board blood analysis via an integrated optical imaging platform. A single device will be able to support the throughput of most emergency departments; in this way, the proposed device would serve as an all-in-one portable STAT lab for rapid, automated emergency diagnostics. Outside of emergency medicine, the device could furthermore have strong impact in areas such as ambulatory and outpatient facilities, pediatric and geriatric care, as well as military use.

 描述：诊断性血液检查是美国最普遍的临床程序，每年进行超过10亿个测试。传统的血液测试方法涉及进行静脉穿刺，将样品运送到集中式实验室，使用大型台式仪器分析样品，并将结果转移到临床上。这是一个实验室的密集，耗时且昂贵的过程，并且出乎意料的延迟通常是由于执行静脉穿刺的困难或运输和分析样品所需的时间。参与医院急诊室（ED），患者状况的快速变化需要立即反应，因此延迟可能会威胁生命。出现了护理点（POC）血液测试，是一种潜在减少周转时间的一种方式，基于毛细血管抽血的几种设备已经实现了商业翻译。但是，与集中测试相比，现有的POC测试的量仍然有限，并且毛细血管血液获得的结果的准确性仍然有争议。通过静脉穿刺吸收静脉血，可以收集大量的血液，因为样品直接来自循环，从而产生了更多的依赖性结果。但是，迄今为止，尚无作为独立单位的全自动静脉通道设备，或与POC测试平台相结合。为了解决这些当前的局限性，我们的小组正在开发一种可便携式的自动化设备，该设备可以执行静脉穿刺，并在患者护理时在15至30分钟内提供定量的诊断结果。便携式设备将通过对患者的静脉进行成像，自主将针头引入选定的静脉，将血液引入微流体芯片中，并通过集成的光学成像平台进行船上血液分析。单个设备将能够支持大多数急诊室的吞吐量；这样，提议的设备将作为快速自动紧急诊断的多合一便携式统计实验室。在急诊医学之外，该设备还可以在诸如门诊和门诊设施，儿科和老年护理以及军事用途等地区产生巨大影响。