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

这个小企业创新研究(SBIR)第一阶段项目的广泛影响/商业潜力将使每年近600万名被怀疑患有异常胃食道反流(GER)的儿童受益，这些儿童可能会导致更严重的疾病，以及许多称为胃食道反流病(GERD)的并发症。目前的检测模式包括昂贵的侵入性程序，通常需要过夜住院，在没有客观证据的情况下开出药理质子泵抑制剂(PPI)和/或暴露于放射成像。该项目的成果将导致一种低成本、非侵入性的GER检测方法，而不需要住院。这将有助于及早发现GER，并降低与GERD及其伴随并发症相关的整体医疗成本和负担。拟议的项目将展示使用单点超声换能器进行非侵入性检测和表征反流的可行性。电流反流检测依靠阻抗和pH探头，这些探头通过鼻胃探头放置在患者S的食道内。这通常需要麻醉和过夜的医院观察，这是昂贵的，有侵入性的，而且容易出现伪影，改变患者通常经历的反流发作。超声成像可以观察食道中发生的反流，但需要在一个探头中使用数百个超声换能器，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很高，并阻止其长时间使用，这对于确定是否发生反流量是必要的。拟议的项目将使用超声波成像作为控制方法，以演示单点超声波换能器产生声学特征的能力，该声学特征能够检测食道是扩张还是收缩，以识别反流事件。通过单点传感器检测和表征回流最终将使便携式、安全和准确的家庭监控设备的开发成为可能。

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.