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

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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.