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

这项小型企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力每年将使近600万名疑似患有异常胃食管反流（格尔）的儿童受益，这种异常胃食管反流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和侵入性的程序，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具药理学质子泵抑制剂（PPI）。 该项目的结果将导致一种低成本，非侵入性的方法来检测格尔，而不需要住院治疗。 这将有助于早期发现格尔和减少整体医疗费用和负担与胃食管反流病及其伴随complications.The拟议的项目将证明使用单点超声换能器的可行性，非侵入性检测和表征反流。 目前的反流检测依赖于放置在患者体内的阻抗和pH探头？的食管通过鼻胃探针。 这通常需要麻醉和住院过夜观察，这是昂贵的、侵入性的，并且容易产生改变患者通常经历的反流发作的伪影。 超声成像可以观察食管中发生的反流，但需要单个探头中的数百个超声换能器和训练有素的临床医生来手动观察和识别反流事件。 这两个因素使得超声成像使用成本高，并阻止其长时间使用，这对于确定是否发生异常量的反流是必要的。 拟议项目将使用超声成像作为对照方法，以证明单点超声换能器能够生成能够检测食管是否扩张或塌陷的声学特征，从而识别反流事件。 通过单点传感器检测和表征返流将最终实现便携式、安全和准确的家庭监测设备的开发。

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.