Noninvasive Total Hemoglobin Monitor

无创总血红蛋白监测仪

• 批准号: 8057014
• 负责人: JONAS ALEXANDER POLOGE
• 金额: $ 16.51万
• 依托单位: KESTREL LABS, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-22 至 2012-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8057014
• 关键词: Amplifiers; Animals; Applications Grants; Area; Blood; Blood Tests; Blood Transfusion; Blood specimen; Blood-Borne Pathogens; Calibration; Caregivers; Caring; Cells; Clinical; Communities; Coupled; Data; Data Set; Development; Devices; Diagnosis; Diagnostic tests; Distress; Electric Capacitance; Ensure; Erythrocytes; Evaluation; Event; Exposure to; Feasibility Studies; Fiber; Fingers; Goals; Gold; Government; Grant; Health Care Costs; Healthcare; Healthcare Systems; Hemoglobin; Hemoglobin concentration result; Hemorrhage; Indium; Infection; Lasers; Lead; Left; Light; Liquid substance; Marketing; Measurement; Measures; Medical; Modeling; Monitor; Operative Surgical Procedures; Optics; Outcome; Oxygen; Pain; Patient Monitoring; Patients; Performance; Persons; Photoplethysmography; Physiologic pulse; Physiological; Pulse Oximetry; Regression Analysis; Reporting; Risk; Sales; Sampling; Signal Transduction; Small Business Innovation Research Grant; Speed; System; Testing; Time; Tissues; Transfusion; Trauma; Work; base; clinically relevant; cost; density; design; detector; disease diagnosis; experience; gallium arsenide; hospital laboratories; human subject; improved; instrument; meetings; product development; prototype; sensor

DESCRIPTION (provided by applicant): It is a rare event when new and useful medical parameters can be added to the suite of monitoring and diagnostic tests available in a clinical setting. Of particular importance is the ability to measure crucial physiological parameters or analytes in a continuous and noninvasive manner-evidenced by the importance of noninvasive vital signs monitoring-because it reduces expense, eliminates delays in diagnosis, and removes the potential for exposure to blood-borne pathogens. The project for which this SBIR Grant proposal is being submitted will determine the feasibility of creating a new patient monitor capable of accurate, noninvasive, and continuous measurements of total hemoglobin (tHb). The measurement of total hemoglobin is a crucial and frequently performed blood test used in nearly all areas of healthcare. The accurate measurement of this parameter is particularly important for patients potentially requiring a transfusion, receiving rapid administration of fluids, undergoing a surgical procedure, or having experienced trauma that has resulted in significant blood loss. The proposed new monitor would look much like conventional pulse oximeter, the ubiquitous vital-signs monitor that has been in clinical use since the 1980s and which uses a clothespin-like sensor to "shine" red and infrared light through the finger and report a measure of the oxygen level in the arterial blood. And, in fact, the ultimate goal of the product development effort that would follow this feasibility study will be the integration of total-hemoglobin-measuring capability into a pulse oximeter. Successful completion of the proposed grant work will be a crucial first step toward the creation of this new medical monitor. This work will prove that the high measurement precision provided by the use of narrow-band lasers in pulse oximetry can make possible the accurate noninvasive measurement of tHb over the entire clinically-relevant range. The continuation of this work into the development of a full commercial version that can be calibrated and verified on animal and human subjects will then lead to submission for FDA 510(k) clearance to allow the marketing and sale of this device to the medical community. Availability of a noninvasive total hemoglobin monitor will help diagnose anemic patients sooner and contribute to the judicious use of blood transfusions, all with less pain or risk of infection while reducing the time burden on caregivers and costs to the healthcare system. PUBLIC HEALTH RELEVANCE: An important part of medical care is the use of tests that help clinicians diagnose disease or other medical conditions, but often these tests require that blood or other samples be drawn from the body and sent to a central hospital laboratory. The proposed work has an ultimate goal of creating a monitor that can measure the levels of red blood cells in a patient's blood without the need to draw a blood sample. This will ease patient distress and risk of infection, speed diagnosis, and result in improved patient outcomes and reduced healthcare costs.

描述（由申请人提供）：将新的有用的医疗参数添加到临床环境中可用的监测和诊断测试套件中的情况很少见。特别重要的是能够以连续和无创的方式测量关键的生理参数或分析物（无创生命体征监测的重要性证明了这一点），因为它减少了费用，消除了诊断延误，并消除了暴露于血源性物质的可能性。病原体。正在提交此 SBIR 拨款提案的项目将确定创建能够准确、无创和连续测量总血红蛋白 (tHb) 的新型患者监护仪的可行性。总血红蛋白的测量是一项至关重要且经常进行的血液检测，几乎用于所有医疗保健领域。该参数的准确测量对于可能需要输血、接受快速输液、接受外科手术或经历过导致大量失血的创伤的患者尤其重要。拟议的新型监测仪看起来很像传统的脉搏血氧计，这是一种自 20 世纪 80 年代以来一直在临床使用的无处不在的生命体征监测仪，它使用类似衣夹的传感器通过手指“照射”红色和红外光并报告测量结果动脉血中的氧含量。事实上，这项可行性研究之后的产品开发工作的最终目标是将总血红蛋白测量功能集成到脉搏血氧计中。成功完成拟议的资助工作将是创建这种新的医疗监测仪的关键的第一步。这项工作将证明，在脉搏血氧测定中使用窄带激光所提供的高测量精度可以使在整个临床相关范围内准确无创地测量 tHb 成为可能。继续这项工作开发一个完整的商业版本，可以在动物和人类受试者上进行校准和验证，然后将提交 FDA 510(k) 许可，以允许该设备向医学界营销和销售。无创总血红蛋白监测仪的出现将有助于更快地诊断贫血患者，并有助于明智地使用输血，所有这些都可以减少疼痛或感染风险，同时减少护理人员的时间负担和医疗保健系统的成本。 公共卫生相关性：医疗护理的一个重要部分是使用帮助临床医生诊断疾病或其他医疗状况的测试，但这些测试通常需要从体内抽取血液或其他样本并送往中心医院实验室。拟议工作的最终目标是创建一种无需抽取血样即可测量患者血液中红细胞水平的监测仪。这将减轻患者的痛苦和感染风险，加快诊断速度，并改善患者的治疗效果并降低医疗成本。