Wear-and-Forget Electrocardiogram and Ventilation Sensor Suitable for Multi-day Use in Physically-Active Warfighters

The Mini Mitter Company, Inc. will utilize its proprietary technologies and experience to develop a miniature, low-cost, wear-and-forget, Integrated Telemetric Monitoring System (ITMS). The monitoring system design will integrate sensor technology forrecording electrocardiogram (ECG), heart rate (HR), and ventilation (including respiratory rate (RR) and blood oxygen level (SPO2) in fully ambulatory environments. Accurately monitoring individual physiologic status under real-time environmentalconditions and stressors through miniaturized wireless technology is the core expertise of Mini Mitter. The deliverable is an integrated telemetric sensor and monitoring system that allows recording of vital statistics in a continuum of time sensitiverecordings. The telemetric monitoring system will utilize existing unique integrated physiological monitoring technology to directly benefit soldiers who are deployed in extreme and hazardous environmental conditions where immediate medical resources arenot readily available. The specific aims and design of this new proprietary technology incorporates:1.Microprocessor-controlled digital sensors with periodic, time-multiplexed architecture, and uniquely encoded data transmissions to avoid cross talk between sensors in close proximity.2.Sensors delivering accuracy and repeatability in a device requiring low power.3.An electronic circuit to convert the data to a digital format.4.A receiver that detects and interprets the digital signals from a collection of sensors.The complete system will consist of ECG, HR, and, ventilation (including RR and SPO2), sensors that receive, record and transmit these vital statistics in an integrated, time sensitive continuum to a user-worn field monitor that receives and temporarilystores the data. Mini Mitter's proven engineering ability and experience in miniaturized core body and dermal temperature sensors will facilitate rapid, low-cost expansion of new technology into a complete telemetric monitoring system. There are numerous applications for the Integrated Telemetric Monitoring System (ITMS) identified in medical research communities and clinical treatment settings especially in the inpatient, outpatient, and ambulatory care environments, where studies andactual monitoring and intervention may be provided for high risk populations in low-cost settings. The ITMS will be an essential and economical monitoring device designed to benefit women, children and minorities who may not have access to other means ofhealthcare or are limited in their ability to spend costly days in inpatient observation. A wear-and-forget, and easy-to-use wireless monitoring system for core body temperature (CBT), HR, ECG, ventilation, (including blood oxygen level (SPO2) andrespiration (RR))and physical activity will provide a continuum of time sensitive, noise-free, accurate detection of these vital signs without the use of interconnecting wires. The ability to monitor these vital signs continuously in inpatient andambulatory environments will enhance early detection and monitoring of chronic and acute medical conditions like infection, sepsis and arrhythmias with symptoms that include fever, palpitations, syncope, lightheadedness, dyspnea, transient ischemicattacks, vertigo, epilepsy and falls. This configuration allows for freedom of movement and minimal patient intervention while continuously monitoring pertinent vital signs. The sensors for the system are disposable, lightweight, easily attached andremoved, and biocompatible. A small, user-worn field monitor is implemented to receive data telemetrically from the body sensors and is capable of recording integrated vital signs data for extended periods of time. Ideally, and with the cooperation ofother industry partners, the data is re-transmitted to a central monitoring base station remotely located from the field or patient worn receiver/monitor allowing for expert analysis, diagnostic and therapeutic decision-making.