SBIR Phase I: Novel Device for detecting changes in the esophageal lumen using single point ultrasonic transducers

这项小企业创新研究（SBIR）一期项目的广泛影响/商业潜力将使每年近600万被怀疑患有异常胃食管反流（GER）的儿童受益，这种疾病可能导致更严重的疾病，并伴有许多并发症，称为胃食管反流病（GERD）。目前的检测范式包括昂贵且侵入性的手术，通常需要住院过夜，在没有客观证据和或暴露于放射成像的情况下开药理学质子泵抑制剂（PPIs）。该项目的成果将导致一种低成本、无创的检测GER的方法，而无需住院治疗。这将有助于早期发现胃食管反流症，并减少与胃食管反流症及其伴随并发症相关的总体医疗费用和负担。拟议的项目将证明使用单点超声换能器无创检测和表征回流的可行性。电流反流检测依赖于放置在患者体内的阻抗和pH探头。S食管通过鼻胃探头。这通常需要麻醉和夜间住院观察，这是昂贵的，侵入性的，并且容易发生改变患者通常经历的反流发作的人工制品。超声成像可以观察食管发生的反流，但需要在单个探头中安装数百个超声换能器，并需要训练有素的临床医生手动观察和识别反流事件。这两个因素使超声成像的使用成本高昂，并阻止它被用于延长的时间，这是必要的，以确定是否异常数量的反流正在发生。拟议的项目将使用超声成像作为控制方法，以证明单点超声换能器产生声学特征的能力，该声学特征能够检测食道是否扩张或塌陷，以识别反流发作。通过单点换能器检测和表征回流将最终使便携式、安全、准确的家庭监测设备的发展成为可能。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will benefit nearly 6 million children per year who are suspected of having abnormal Gastroesophageal Reflux (GER) which can lead to a more serious condition with numerous complications referred to as Gastroesophageal Reflux Disease (GERD). Current detection paradigms include costly and invasive procedures that often require overnight hospitalization, prescribing pharmacological Proton Pump Inhibitors (PPIs) without objective evidence and or exposure to radiological imaging. The outcomes of this project will lead to a low cost, non-invasive method for detecting GER, without requiring hospitalization. This will facilitate earlier detection of GER and reduce overall healthcare costs and burdens associated with GERD and its accompanying complications.The proposed project will demonstrate the feasibility of using single point ultrasonic transducers to non-invasively detect and characterize reflux. Current reflux detection relies on impedance and pH probes which are placed in the patient?s esophagus through a nasogastric probe. This often requires anesthesia and overnight hospital observation which is costly, invasive, and prone to artifacts that change the reflux episodes normally experienced by the patient. Ultrasonic imaging can observe reflux occurring in the esophagus but requires hundreds of ultrasonic transducers in a single probe and a trained clinician to manually observe and identify the reflux events. These two factors make ultrasonic imaging costly to use and prevents it from being used for extended periods of time, which is necessary to determine if abnormal amounts of reflux are occurring. The proposed project will use ultrasonic imaging as a control method to demonstrate the ability of single point ultrasonic transducers to generate an acoustic signature capable of detecting whether the esophagus is expanded or collapsed to identify episodes of reflux. Detection and characterization of reflux through single point transducers would ultimately enable the development of a portable, safe, and accurate home monitoring device.