SBIR-STTR Award

Accurate measurement of core body temperature during surgery as well as in critical care is imperative to a positive outcome and ongoing quality of life for patients. Core temperature management of patients during extended anesthesia such as cardio-pulmonary bypass (CPB) surgery is equally important, yet there is no accurate core body measurement device available to physicians, surgeons and staffs today. With success in kidney and bladder temperature detection and monitoring, Thermimage is now developing the AccuTemp" Sensor, a non-invasive microwave based system to accurately and rapidly measure the core brain temperature at 4-5 cm. This system consists of a 2.5 cm receiving microwave antenna that will be placed on the patient's forehead, and a specialized radiometer to amplify and process the antenna signal to determine the actual brain temperature. The device will detect the energy emitted from the brain at near cellular phone frequencies (800-2500MHz), with a sensitive receiver that can detect microwave signals that are only a billionth of a watt strong. Core temperature monitoring devices used today infer temperature, but lack accuracy and the ability to rapidly report core temperature changes. Solid organ temperature from the heart, liver, spleen, kidneys and brain are best when monitoring core temperature and among these, the best and most critical measurement for treatment decisions is the brain. There are numerous surrogates of core temperature including oral, rectal, bladder, esophageal, tympanic and nasopharyngeal measures. These measures may be approximately correct when body temperature is stable. However, all are inadequate to detect and report the temperature of the brain when it is stable, or rapidly changing, either of which may require an immediate response from the surgical team. The most accurate predictions of brain temperature today uses intravascular sensors in the pulmonary artery or jugular vein, but these are inconvenient and potentially harmful. Even sensors directly in the brain have shown that when hypothermia is induced and reversed rapidly, standard monitoring sites fail to reflect cerebral temperature. Accurate body temperature monitoring is being emphasized in new physician practice guidelines with some ties to performance including a 2% reimbursement penalty to anesthesiologists not meeting the standard after 2014. It is imperative that anesthesiologists, intensive care physicians, neonatologists, and emergency physicians monitor the core body temperature for best patient outcomes. Clearly there is a need for new measuring body core temperature that provides fast and accurate readings of the body's most sensitive tissue, the brain. Thermimage's development of the novel AccuTemp Sensor will safely and reliably monitor deep brain temperature non-invasively, assisting greatly in creating best outcomes for patients, physicians and institutions.

Public Health Relevance Statement:


Public Health Relevance:
The need for physicians to know patient core body temperature during surgery has never been greater with accurate core temperature monitoring being emphasized in new physician practice guidelines as a method to lower morbidity, reduce infection, and shorten surgical recovery. Thermimage is developing the AccuTemp" Sensor to provide non-invasive core temperature measured 4-5 cm deep within brain tissue enabling accurate, non-invasive monitoring during surgery with no inherent risk. The device will have immediate positive impacts for hypothermic anesthesia, near drowning and to exposure patients with additional opportunities to quickly follow.

Project Terms:
Adopted; Anesthesia procedures; base; Bladder; Body measure procedure; Body Temperature; Brain; brain tissue; Bypass; Caliber; Calibration; Cardiac Surgery procedures; Cataloging; Catalogs; Cellular Phone; Cerebrum; Clinical; Clinical Trials; Computer software; cost; cranium; Critical Care; Critical Illness; Detection; Development; Devices; Drops; Emergency Situation; Esophageal; Exposure to; Feedback; follow-up; Forehead; Frequencies (time pattern); Goals; Government; Head; Heart; Hemorrhage; Hospitalization; Hour; Human; improved; Infection; Institution; Institutional Review Boards; Intensive Care; Investigation; Kidney; Length; Liquid substance; Liver; Lung; Maintenance; Measurement; Measures; meetings; Methods; microwave electromagnetic radiation; Modeling; Monitor; monitoring device; Morbidity - disease rate; Myocardial; natural hypothermia; Near Drowning; non-invasive monitor; non-invasive system; novel; Operating Rooms; Operative Surgical Procedures; Oral; Organ; Organ Temperatures; Outcome; patient safety; Patients; Performance; Phase; Physicians; Practice Guidelines; Preparation; Procedures; Process; Protocols documentation; public health relevance; Pulmonary artery structure; Quality of life; Radiometry; Reading; Recovery; Recovery Room; rectal; Regulation; Reporting; response; Risk; Scalp structure; sensor; Signal Transduction; Site; Solid; Spleen; Staging; Structure of jugular vein; success; Surgeon; Surgical complication; Surgical Wound Infection; System; Technology; Temperature; Testing; Time; Tissue Model; Tissues; Work

There is a growing need for accurate and continuous non-invasive monitoring of brain temperature in hospitals and clinics throughout the world. The need for physicians and anesthesiologists to know the brain as well as the core body temperature of a patient is well established. Temperature management of patients under anesthesia during cardio-pulmonary bypass surgery is imperative to a positive outcome and ongoing patient quality of care, yet there is no non-invasive, accurate measurement device available to physicians. Current practice guidelines for anesthesiologists, intensive care physicians, neonatologists, and emergency physicians require the monitoring of the core brain temperature. However, there are no devices that provide immediate, accurate data. Devices that are non-invasive only measure superficial temperatures, insufficient for critical situations. Invasive monitors are placed into the bladder, rectum, esophagus or the nasopharynx to measure core temperature more accurately, but the medical professional must then infer the most important temperature, brain temperature, with the hope that this is "accurate enough" for critical medical decisions during surgical operations and difficult intensive care unit stays. Thee are several devices that attempt to measure brain temperature. The most accurate prediction of brain temperature today uses intravascular sensors in the pulmonary artery or jugular vein, but these are invasive, inconvenient and potentially harmful. Even sensors directly in the brain have shown that when hypothermia is induced and reversed rapidly, standard monitoring sites fail to reflect cerebral temperature. With success in kidney and bladder temperature detection and monitoring, Thermimage is now developing the AccuTemp" Sensor, a non-invasive radiometric based system to accurately and rapidly measure the core brain temperature 5 cm deep. This system consists of a >2.5 cm diameter receiving microwave antenna placed on the patient's forehead, and a specialized radiometer to amplify and process the antenna signal to determine the actual brain temperature. The device detects the energy emitted from the brain at low frequencies with a sensitive receiver that detects signal strength of only a billionth of a watt. There is a clear need for a new, non-invasive temperature measurement device that provides fast and accurate readings of the body's most sensitive tissue, the brain. This Phase II SBIR research and development will demonstrate: 1) the noninvasive sensing technology successfully prepared in Phase I provides reliable monitoring of deep core brain temperature during hypothermic surgery; and 2) the cutting-edge radiometer prototype built in Phase I can be translated into a low-cost system that combines technological innovation with universal commercial appeal and clinical validation.

Public Health Relevance Statement:


Public Health Relevance:
The proposed work is relevant to public health because the clinical implementation of a low-cost microwave device that safely and noninvasively measures deep tissue temperature is expected to significantly expand diagnostic capabilities for a wide range of clinical applications involving thermal regulation within the body, starting with improved control of patients during hypothermic cardiac surgery or with traumatic brain injury. The project has direct relevance to NIH's mission of working toward improved health care at lower cost, by providing a powerful yet affordable diagnostic tool to help avoid complications that occur following routine surgical procedures or care of critically ill patients.

Project Terms:
Address; Amplifiers; Anesthesia procedures; base; Bladder; Body Temperature; Brain; brain tissue; Bypass; Caliber; Calibration; Cardiac Surgery procedures; Cardiopulmonary Bypass; Caring; Cerebrum; Cessation of life; Clinical; clinical application; clinical practice; Clinical Research; Clinics and Hospitals; commercialization; Computer software; cost; Critical Illness; Data; design; Detection; detector; Development; Development Plans; Device Approval; Devices; Diagnostic; Electromagnetics; Electronics; Emergency Department Physician; Environment; Esophageal; Esophagus; Feedback; Forehead; Frequencies (time pattern); Goals; Head; Health Personnel; Healthcare; Hemorrhage; Hospitalization; Hour; Human; Immune; improved; innovation; Institutional Review Boards; instrument; instrumentation; Intensive Care; Intensive Care Units; interest; Ischemic Neuronal Injury; Kidney; Length; Letters; Lung; Marketing; Measurement; Measures; Medical; Medical Device; Medical Research; microwave electromagnetic radiation; Mission; Modeling; Monitor; Myocardial; Nasopharynx; natural hypothermia; new technology; non-invasive monitor; novel; operation; Operative Surgical Procedures; Organ; Outcome; Patient Monitoring; Patients; Phase; Physicians; Pilot Projects; Population Study; Practice Guidelines; Preparation; prevent; Printing; Procedures; Process; Protocols documentation; prototype; public health medicine (field); public health relevance; Pulmonary artery structure; Quality of Care; Radiometry; Reader; Reading; Recovery; rectal; Rectum; Regulation; Research; research and development; research clinical testing; sensor; Signal Transduction; Site; Small Business Innovation Research Grant; Staging; Structure of jugular vein; success; System; technological innovation; Technology; Temperature; Testing; Tissues; tool; Translating; Traumatic Brain Injury; Universities; Utah; Validation; Work