SBIR Phase I: Development of a lactate monitoring device to to provde an alert system for organ failure and death due to shock

这个小型企业创新研究（SBIR）项目的更广泛的影响/商业潜力是开发一种医疗监测设备，以大大改善急诊室和重症监护室重症患者的治疗和护理。这项技术持续监测血液中的乳酸水平。领先的临床医生报告说，医院监测的一个局限性是，生命体征往往不会改变，直到病人病情危重。相比之下，血乳酸水平上升早，表明健康状况恶化。因此，连续乳酸盐监测器将在危重患者的治疗中具有变革性，并且能够进行重要的医学科学研究，从而更好地检测患者面临巨大死亡风险的早期“警告信号”。使用该设备的这种医学研究也将使基于实时乳酸浓度的“目标导向”治疗成为可能。目标导向治疗已经被证明可以显著改善危重患者的预后。然而，由于每次需要乳酸水平时使用医院实验室的后勤负担，很少实施乳酸指导治疗。该设备将取代医院实验室，将一个小芯片戴在皮肤表面。SBIR第一阶段项目建议开发一种连续的乳酸传感器。皮下乳酸传感器将被设计为自动和连续测量危重患者的乳酸浓度。该传感器包括一个可植入的微芯片和一个戴在皮肤上的光电绷带（OEB）。研究目标是将自参考集成到每个设备中，以提高校准稳定性，改善乳酸水平与OEB的经皮光学通信，并最终确定OEB的临床设计。 自我参考的集成将需要一个新的微芯片设计，由化学反应的数学建模指导，并通过在此之前的原型设计过程中开发的微制造技术来实现。改进的光通信将通过改进将发光分子固定到微芯片上的方法来实现。OEB设计冻结将通过将现场可编程门阵列集成到OEB中来实现，OEB可以控制通过皮肤的光通信，通过校准算法将原始数据转换为乳酸盐浓度，并将乳酸盐浓度数据无线传输到基本单元。完成这些目标后，传感器将准备用于临床研究。

The broader impact/commercial potential of this Small Business Innovative Research (SBIR) project is to develop a medical monitoring device to greatly improve treatment and care for critically ill patients in emergency rooms and intensive care units. This technology continuously monitors levels of lactate in the blood. Leading clinicians report that a limitation of hospital monitoring is that vital signs often do not change until a patient is critically ill. Comparatively, blood lactate levels rise early and indicate worsening health. As such, a continuous lactate monitor would be transformative in the treatment of critically ill patients and enable important medical science research leading to better detection of early "warning signs" that a patient is at great risk of death. Such medical research using the device also would enable "goal-directed" treatment based on real-time lactate concentrations. Goal directed treatment already has been shown to significantly improve outcomes in critically ill patients. However, lactate guided treatment is rarely practiced due to the logistical burden of using the hospital laboratory each time a lactate level is needed. The proposed device will replace the hospital laboratory with a small chip worn on the surface of the skin.This SBIR Phase I project proposes to develop a continuous lactate sensor. The subcutaneous lactate sensor will be desgned to automatically and continuously measure lactate concentrations in critically ill patients. The sensor comprises an implantable microchip, and an optoelectronic bandage (OEB) worn on the skin. Research objectives are to integrate a self-reference into each device for improved calibration stability, improve trans-dermal optical communication of lactate levels to the OEB, and to finalize the clinical design of the OEB. Integration of a self-reference will require a new design of the microchip as guided by mathematical modeling of chemical reactions and implemented by microfabrication techniques developed during prototyping prior to this award. Improved optical communication will be accomplished by modification of methods for immobilizing luminescent molecules onto the microchip. OEB design freeze will be accomplished by integrating a field programmable gate array into the OEB that can control optical communication through the skin, convert raw data to lactate concentration via a calibration algorithm, and wirelessly transmit lactate concentration data to a base unit. Following completion of these goals, the sensor will be ready for use in clinical studies.