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/商业影响建议开发一种治疗胃食管反流病（GERD）的微创设备。胃食管反流是美国最常见的胃肠道疾病，约26%的美国成年人（6000万人）患有此病，影响他们的睡眠、工作效率和生活质量，并导致其他胃肠道疾病。大约三分之一的胃食管反流患者尽管接受了治疗，但仍有症状；此外，长期使用目前的处方药有副作用和风险。目前的手术解决方案是侵入性的，昂贵的，并且有很大的风险。该注射系统通过安全的将药物注射到食道底部，降低了医疗成本，提高了患者的生活质量，并有可能降低其他胃肠道疾病的发病率，从而为胃食管反流症提供了一种侵入性更低、成本更低的治疗方法。SBIR二期项目将开发一种内镜注射系统，在食管下段粘膜下组织平面连续多次注射填充剂。这项技术包括一个控制注射深度的新系统，并将针尖指向所需的粘膜下组织。该项目将优化针头和相关导向系统的设计，用于注射粘性溶液，特别是膨胀剂，在食管下部形成粘膜下组织，最终防止胃食管反流。这将是第一个使用双腔注射针和生理盐水辅助注射的系统。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。该奖项反映了美国国家科学基金会的法定使命，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，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.