SBIR Phase II: Endoscopic injection device for submucosal esophageal injection of bulking agents in the treatment of gastroesophageal reflux disease

该SBIR II期项目的更广泛/商业影响旨在开发一种用于治疗胃食管反流病（GERD）的微创器械。 GERD是美国最常见的胃肠道疾病，约26%的美国成年人（6000万人）患有GERD，影响他们的睡眠，生产力和生活质量，并导致其他胃肠道疾病。大约三分之一的GERD患者尽管接受了治疗，但仍会继续出现症状;此外，长期使用目前处方的药物会产生副作用和风险。目前的手术解决方案是侵入性的、昂贵的并且具有很大的风险。所提出的注射系统通过安全地将治疗剂注射到食管底部，为GERD提供了侵入性较小且成本较高的治疗，降低了医疗保健成本，改善了患者的生活质量，并可能降低其他胃肠道疾病的发病率。该SBIR II期项目将开发一种内窥镜注射系统，用于将膨胀剂一致地多次注射到食管下部的粘膜下组织平面中。该技术包括控制注射深度并将针尖引导至所需粘膜下组织的新颖系统。该项目将优化用于注射粘性溶液的针头和相关引导系统的设计，特别是在食管下部产生粘膜下组织隆起并最终防止胃食管反流的膨胀剂。这将是第一个使用双腔注射针并辅以生理盐水引导注射的系统。 该项目将通过快速迭代的3D打印原型进一步探索最终歧管外壳的设计空间。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估而被认为值得支持。

The broader/commercial impact of this SBIR Phase II project proposes to develop a minimally-invasive device for treating gastroesophageal reflux disease (GERD). GERD is the most common gastrointestinal diagnosis in the US, afflicting ~26% of adult Americans (60 million people), undermining their sleep, productivity, and quality of life, and leading to other gastrointestinal diseases. Approximately one-third of GERD patients continue to suffer from symptoms despite treatment; moreover, long-term use of currently prescribed drugs has side effects and risks. Current surgical solutions are invasive, costly and carry significant risk. The proposed injection system offers a less invasive and costly treatment for GERD by safely injecting a treatment into the base of the esophagus, reducing healthcare costs, improving the quality of life for patients, and potentially reducing the incidence of other gastrointestinal diseases. This SBIR Phase II project will develop an endoscopic injection system for consistent multiple injections of bulking agent into the submucosal tissue plane in the lower esophagus. This technology includes a novel system controlling injection depth and directing a needle tip to the desired submucosal tissue. This project will optimize the design of the needle and associated guidance system for injection of viscous solutions, particularly a bulking agent creating submucosal tissue bulging at the lower esophagus and ultimately preventing gastroesophageal reflux. This will be the first system to use a dual lumen injection needle with the assistance of a saline pilot injection. The project will further explore the design space of the final manifold housing with rapid iterative 3D-printing prototyping.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.