A Transcutaneous Gas Sensor for Noninvasive Diagnosis of Necrotizing Enterocoliti

描述(申请人提供)：我们建议开发一种基于纳米结构金属氧化物的非侵入性、室温经皮气体传感器，作为一种快速医学诊断。在第一阶段，我们成功地展示了应用基于二氧化钛纳米管的氢传感器来监测志愿者患者的经皮氢水平以预测乳糖不耐受。在第二阶段，我们将开发一种氢和二氧化碳(H2-CO2)传感器阵列，用于同时检测经皮的H2和CO2水平。经皮气体测量将用于检测可能的酸中毒和坏死性小肠结肠炎(NEC)。该第二阶段项目的具体目标是{1}设计独立、独立的传感器读取器，以及{2}将新的传感器读取器微型化并重新封装到类似手表的设备中。我们还将继续{3}继续制备和改进二氧化钛氢敏元件，以及{4-5}制备和改进用于二氧化碳传感的纳米多孔CuO-WO_3薄膜的性能。在完成传感元件后，我们将{6}开发一种算法，根据传感器的响应确定实际的经皮H2和CO2水平。为了测试传感器系统的性能，我们将首先将经皮H2水平与呼出H2关联，并将经皮CO2与血液CO2关联起来。然后，我们将对确诊为NEC/酸中毒和疑似NEC/酸中毒的早产儿和足月儿进行经皮H2和CO2检测。最后，我们将在治疗和恢复阶段对确诊为NEC/酸中毒的受试者进行经皮气体检测。这个第二阶段的项目将包括来自SentechBioed公司和好时医学中心宾夕法尼亚州立儿童医院的詹姆斯·肯迪格医学博士的科学家和工程师。SentechBimed的主要作用是制造新的传感器读取器和气体敏感元件，并建立校准算法，以及分析用于传感器测量校准的临床研究数据。好时医疗中心的肯迪格博士将进行临床研究，以评估传感器的性能，并收集关键的临床数据进行分析。这项工作的成果是一种非侵入性的实时传感器系统，用于检测某些疾病，这些疾病可以通过监测经皮排泄气体的变化来诊断。事实证明，这种传感器系统对于改善酸中毒和坏死性小肠结肠炎等疾病的早期诊断和护理管理具有巨大的实用价值。

DESCRIPTION (provided by applicant): We propose to develop a noninvasive, room-temperature transcutaneous gas sensor based on the nano-structured metal oxides as a rapid medical diagnostic. In Phase I, we successfully demonstrated the application of a titania nanotube-based hydrogen sensor to monitor transcutaneous hydrogen levels for predicting lactose intolerance in volunteer patients. In Phase II, we will develop a hydrogen and carbon dioxide (H2-CO2) sensor array for simultaneously detecting transcutaneous H2 and CO2 levels. Measurement of the transcutaneous gases will be used for detecting possible acidosis and necrotizing enterocolitis (NEC). The specific objectives of this Phase II project are {1} to design a standalone, self-contained sensor reader and {2} to miniaturize and repackage the new sensor reader into a watch-like device. We will also {3} continue to fabricate and improve the titania H2 sensing elements, as well as {4-5} fabricate and improve the performance of a nanoporous CuO-WO3 film for CO2 sensing. Upon completing the sensing elements, we will {6} develop an algorithm to determine the actual transcutaneous H2 and CO2 levels based on the sensor responses. To test the performance of the sensor system, we will first {7} correlate the transcutaneous H2 levels to exhaled breath H2 and the transcutaneous CO2 to blood CO2. We will then {8} measure the transcutaneous H2 and CO2 on preterm and full term infants with documented NEC/acidosis and suspected NEC/acidosis. Finally, we will {9} measure the transcutaneous gases on the test subjects with confirmed NEC/acidosis during the treatment and recovery phases. This Phase II project will involve scientists and engineers from SentechBiomed Corporation and James Kendig, M.D., of the Penn State Children's Hospital at Hershey Medical Center. The primary role of SentechBiomed is to fabricate the new sensor readers, the gas sensing elements, and establish a calibration algorithm, as well as analyze the clinical research data for sensor measurement calibration. Dr. Kendig at the Hershey Medical Center will conduct clinical research to evaluate the performance of the sensor and collect crucial clinical data for analysis. The outcome of this work is a noninvasive, real time sensor system for detecting certain diseases that can be diagnosed by monitoring the variation in excreted transcutaneous gases. Such a sensor system could prove to be of tremendous utility for improving early diagnosis, and hence care management, of diseases such as acidosis and necrotizing enterocolitis.