AccuTemp Sensor: Radiometry based non-invasive continuous core body temperature monitoring for patients undergoing prolonged anesthesia and critically ill patients.

描述(申请人提供)：在世界各地的医院和诊所，对大脑温度的准确和持续的非侵入性监测的需求日益增长。医生和麻醉师需要了解患者的大脑和核心体温，这一点已经得到了很好的证实。在体外循环手术中，麻醉患者的体温管理对于积极的结果和持续的患者护理质量是必不可少的，但医生还没有可用的非侵入性、准确的测量设备。目前麻醉医生、重症监护医生、新生儿医生和急诊医生的实践指南要求监测核心脑温度。然而，没有设备可以提供即时、准确的数据。非侵入性设备只能测量表面温度，不能用于危急情况。侵入性监测仪被放置在膀胱、直肠、食道或鼻咽部，以更准确地测量核心温度，但医疗专业人员随后必须推断出最重要的温度，即大脑温度，希望这一温度能够在外科手术和困难的重症监护病房停留期间做出关键的医疗决策。这是几种尝试测量大脑温度的设备。今天对大脑温度最准确的预测是使用位于肺动脉或颈静脉的血管内传感器，但这些传感器具有侵入性，不方便，而且可能有害。即使是直接在大脑中的传感器也表明，当体温过低被诱导并迅速逆转时，标准的监测位置无法反映大脑温度。随着肾脏和膀胱温度检测和监测的成功，ThermImage现在正在开发AccuTemp“传感器”，这是一种基于非侵入性辐射测量的系统，可以准确、快速地测量5厘米深的核心大脑温度。该系统包括放置在患者额头上的直径2.5厘米的接收微波天线，以及专门的辐射计，用于放大和处理天线信号，以确定实际的大脑温度。该设备通过一个仅检测到十亿分之一瓦信号强度的灵敏接收器来检测从大脑发射的低频率能量。显然，需要一种新的、非侵入性的体温测量设备，能够快速准确地读取人体最敏感的组织--大脑。这项第二阶段的SBIR研发将证明：1)第一阶段成功制备的非侵入性传感技术为低温手术期间提供了可靠的深核心脑温监测；2)第一阶段构建的尖端辐射计原型可以转化为结合技术创新、普遍商业吸引力和临床验证的低成本系统。

DESCRIPTION (provided by applicant): 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.