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

摘要 我们相信，我们的项目是对HLS16-02小型企业专题的响应 NHLBI 2016财年的利息。在这里，我们将开发商业化准备的高级 功能成像仪用于评估红细胞(RBC)输注。我们成功地完成了第一阶段 通过开发设备的原型并在原理证明中测试其功能 散布体模和两种背部窗小鼠模型的实验。在项目的第二阶段 该装置将在背窗动物身上用已建立的功能显微镜进行验证 模型，接下来将RBC输注微循环终点标记物与 建立脏器健康标志的颅窗小鼠模型及最终设计 临床就绪成像仪的软件将在志愿者的小型研究中最终敲定。钥匙 该成像仪的特点是能够量化包括组织在内的局部微循环参数 通过手持探头进行氧气供应和消耗，以方便组织接触。我们的市场 研究和分析表明，对这种仪器的需求很大，以帮助医生 有效地进行红细胞输注，这是住院期间最常见的操作程序。我们 据估计，我们的设备每年可以在美国节省高达3亿美元的医疗成本。 目前还没有明确的红细胞输注效率评价指标，除了 血红蛋白和红细胞压积水平，这并不能说明功能。常规优化 大循环指标(动脉血压、心输出量等)和组织灌流(酸中毒， 乳酸、静脉血氧饱和度(SvO2)、器官功能等。)参数不能说明 取得了有益的成果。我们假设微循环，包括毛细血管密度，血液 直径20-100微米的小动脉和小静脉的氧合、流动和吸氧。 可为优化红细胞输注提供关键终点。降低……的风险 在易感染或受伤的患者中，为了最大限度地减少抽血次数，无创 微循环评估，如果有效，将比有创或微创更受欢迎。 侵入性的方法。我们相信，我们的方法提供了解决关键问题所需的性能 问题和通向成功商业化的明确途径。 该项目将通过提供关键的临床信息来改善 病人的结果。局部组织氧输送和消耗的定量成像不会 只有通过输注红细胞才能改善预后，但在降低发病率和 许多具有血管病因学的破坏性疾病的死亡率，包括各种恶性肿瘤， 炎症性、缺血性、感染性和免疫性疾病。

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.