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

这个SBIR第二阶段项目的更广泛的商业影响建议开发一种治疗胃食道反流病(GERD)的微创设备。GERD是美国最常见的胃肠道疾病，困扰着大约26%的美国成年人(6000万人)，损害他们的睡眠、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，但仍继续出现症状；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，成本高昂，而且有很大的风险。拟议的注射系统为GERD提供了一种侵入性更小、成本更高的治疗方法，它将一种治疗方法安全地注入食道底部，降低了医疗成本，改善了患者的生活质量，并有可能降低其他胃肠道疾病的发生率。这个SBIR第二阶段项目将开发一种内窥镜注射系统，用于将膨胀剂持续多次注射到食道下部的粘膜下组织平面。这项技术包括一种新的系统，可以控制注射深度并将针尖指向所需的粘膜下组织。该项目将优化注射粘性溶液的针头和相关引导系统的设计，特别是一种在食道下部产生粘膜下组织膨胀并最终防止胃食道反流的膨胀剂。这将是第一个在盐水先导注射的辅助下使用双腔注射针的系统。该项目将进一步探索具有快速迭代3D打印原型的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智力优势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.