HLS - Hand-held advanced functional imager for assessing local tissue oxygenation

HLS - 用于评估局部组织氧合的手持式高级功能成像仪

• 批准号: 9346604
• 负责人: Nishant Mohan
• 金额: $ 73.66万
• 依托单位: WASATCH PHOTONICS, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-03-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9346604
• 关键词: 3-Dimensional; Acidosis; Address; Adhesions; Adoption; Adult; Anatomy; Angiography; Animal Model; Animals; Blood; Blood Pressure; Blood Vessels; Blood capillaries; Blood flow; Brain; Businesses; Caliber; Cardiac Output; Cephalic; Clinical; Clinical Research; Communicable Diseases; Computer software; Consumption; Critical Care; Critical Illness; Darkness; Data; Devices; Disease; Dorsal; Endothelial Cells; Erythrocyte Transfusion; Erythrocytes; Etiology; Evaluation; Feedback; Goals; Hand; Health Care Costs; Hematocrit procedure; Hemoglobin; Hospitals; Human Volunteers; Image; Immune System Diseases; Infection; Inflammatory; Injury; Inpatients; Intensive Care Units; Lead; Life; Malignant - descriptor; Maps; Market Research; Measurement; Measures; Methods; Microcirculation; Microscopy; Modification; Monitor; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Near-Infrared Spectroscopy; Optical Coherence Tomography; Organ; Oxygen; Patient-Focused Outcomes; Patients; Performance; Perfusion; Phase; Physicians; Positioning Attribute; Procedures; Recruitment Activity; Regulation; Research Personnel; Resolution; Risk; Safety; Savings; Social Impacts; Spectrum Analysis; System; Testing; Time; Tissue imaging; Tissues; Transfusion; Universities; Venous; arteriole; base; capillary; cohort; commercialization; cost effective; data acquisition; density; design; experimental study; graphical user interface; healthy volunteer; imaging modality; improved; improved outcome; in vivo; innovation; innovative technologies; instrument; interest; minimally invasive; mortality; mouse model; multimodality; non-invasive imaging; photonics; portability; prototype; quantitative imaging; software development; success; tissue oxygenation; tool; user-friendly; venule; volunteer

Summary We believe that our project is responsive to the HLS16-02 Small Business Topic of Special Interest for NHLBI Fiscal Year 2016. Here, we will develop commercialization-ready advanced functional imager to assess red blood cell (RBC) transfusion. We successfully finished Phase I by developing the device’s prototype and testing its functionality in the proof-of-principle experiments in scattering phantom and two dorsal window mice models. In Phase II of the project the device will be verified with established functional microscopy in the dorsal window animal model, next the RBC transfusion microcirculation endpoint markers will be correlated with established organ wellness markers in the cranial window mouse model and finally the design and software of the clinically-ready imager will be finalized in a small study of volunteers. The key features of the imager are the ability to quantify local microcirculation parameters including tissue oxygen supply and consumption with a handheld probe for easy tissue access. Our market research and analysis indicates a strong demand for such instrument to help physicians effectively perform RBC transfusion, which is the most common inpatient hospital procedure. We estimate that our device can save annually up to $300 million in health care costs in the US. Currently there are no defined markers of the RBC transfusion efficiency evaluation, except the hemoglobin and hematocrit level, which do not address function. Conventional optimization of macrocirculatory (arterial blood pressure, cardiac output etc.) and tissue perfusion (acidosis, lactate, venous O2 saturation (SvO2), organ function etc.) parameters do not demonstrate beneficial results. We hypothesize that the microcirculation, including capillary density, blood oxygenation, flow and oxygen extraction in arterioles and venules with diameters of 20-100 µm, can provide crucial endpoints for optimization of the RBC transfusion. To reduce the risk of infection or injury in vulnerable patients and to minimize number of blood draws, a non-invasive microcirculation assessment, if validated, would be highly preferred over invasive or minimally invasive methods. We believe our approach provides the needed performance to solve a critical problem and a clear path to successful commercialization. This project will have strong social impact by providing crucial clinical information to improve patient outcomes. Quantitative imaging of local tissue oxygen delivery and consumption will not only improve outcomes with RBC transfusion but has great potential to decrease morbidity and mortality in many devastating diseases with vascular etiology including a variety of malignant, inflammatory, ischemic, infectious and immune disorders.

概括 我们相信我们的项目响应了 HLS16-02 小型企业特别主题 NHLBI 2016 财年感兴趣。在这里，我们将开发可商业化的先进技术 用于评估红细​​胞（RBC）输注的功能成像仪我们成功完成了第一阶段。 通过开发设备原型并在原理验证中测试其功能 散射体模和两个背窗小鼠模型的实验 在该项目的第二阶段。 该装置将在背窗动物中通过已建立的功能显微镜进行验证 模型中，下一步红细胞输注微循环终点标记将与 在颅窗小鼠模型中建立器官健康标记，最后进行设计 临床就绪成像仪的软件将在一项针对志愿者的小型研究中最终确定。 成像仪的特点是能够量化局部微循环参数，包括组织 使用手持式探头进行氧气供应和消耗，方便进入我们的市场。 研究和分析表明对此类仪器的强烈需求来帮助医生 有效地进行红细胞输注，这是最常见的住院医院程序。 据估计，我们的设备每年可为美国节省高达 3 亿美元的医疗保健费用。 目前，红细胞输注效率评价尚无明确的标志物，除了 血红蛋白和血细胞比容水平，不涉及功能优化。 大循环（动脉血压、心输出量等）和组织灌注（酸中毒、 乳酸、静脉氧饱和度（SvO2）、器官功能等）参数无法证明 我们追求的是微循环，包括毛细血管密度、血液。 直径为 20-100 µm 的小动脉和小静脉中的氧合、流量和氧气提取， 可以为优化红细胞输注提供关键终点，以降低风险。 避免易受感染或受伤的患者，并尽量减少抽血次数，这是一种非侵入性的方法 微循环评估如果得到验证，将比侵入性或微创评估更受青睐 我们相信我们的方法提供了解决关键问题所需的性能。 问题和成功商业化的明确路径。 该项目将通过提供重要的临床信息来改善社会影响 局部组织氧输送和消耗的定量成像不会。 红细胞输注只能改善结果，但具有降低发病率和降低发病率的巨大潜力 许多具有血管病因的毁灭性疾病的死亡率，包括各种恶性、 炎症、缺血、感染和免疫性疾病。