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

该SBIR一期项目建议开发一种微创设备，通过将专有物质安全地注射到食管底部，可用于治疗胃食管反流病（GERD）。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。尽管目前可用的药物治疗，大约三分之一的胃食管反流患者仍有症状。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。该注射系统有望为胃食管反流症提供一种新颖、侵入性更小、成本更低的治疗方法，从而降低整体医疗成本，预防或减少其他胃肠道疾病的发病率。鉴于GERD的巨大市场规模和深刻的临床需求，该项目直接解决了开发这种治疗GERD患者的关键障碍。它有可能显著改善对这种常见疾病的治疗，成为一种护理标准，并创造税收和就业机会。该项目旨在开发一种内窥镜注射系统，用于向食管下部粘膜下组织平面连续多次注射填充剂。这项技术的核心是一种新型注射系统，它利用吸口抓住食管壁，并将针尖指向所需要的粘膜下组织深度。针和导针系统的设计将针对注射粘性溶液进行优化，并将用于注射膨胀剂，使食管下部粘膜下组织膨大，最终防止胃食管反流。所提出的装置在其准确引导粘膜下注射到所需组织平面的能力上将是独一无二的。这将是第一个使用真空辅助的系统，用于粘膜下空间的靶向注射。将采用快速迭代3d打印原型来优化导针几何形状和设计。该系统注射的可重复性将在多个尸体猪食道组织和猪尸体样本中进行测试。Impleo已经拥有一项在食管中注入填充剂的美国方法专利，并计划在该项目中获得更多的知识产权。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。

This SBIR Phase I project proposes to develop a minimally-invasive device that can be used to treat gastroesophageal reflux disease (GERD) by safely injecting a proprietary substance into the base of the esophagus. 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 currently available medications 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 is expected to enable a novel, less invasive and less costly treatment for GERD, leading to reduction of overall healthcare costs and preventing or reducing the incidence of other gastrointestinal diseases. Given the large market size for GERD and profound clinical need, this project directly addresses a critical barrier to developing such therapy for GERD patients. It has the potential to significantly improve treatment of such a common disorder, to become a standard of care and generate tax revenues and jobs. The project seeks to develop an endoscopic injection system for consistent multiple injections of bulking agent into the submucosal tissue plane in the lower esophagus. At the heart of this technology will be a novel injection system that utilizes a suction port to grasp the esophageal wall and direct a needle tip to the desired submucosal depth of the affixed tissue. The design of the needle and needle guidance system will be optimized for injection of viscous solutions and will be used for injection of a bulking agent that creates submucosal tissue bulging at the lower esophagus, ultimately preventing gastroesophageal reflux. The proposed device will be unique in its ability to accurately guide submucosal injections to the desired tissue plane. This will be the first system to use vacuum assist for targeted injections into submucosal space. Rapid iterative 3D-printing prototyping will be employed to optimize needle guide geometry and design. Repeatability of the injections with the system will be tested into multiple samples of cadaveric porcine esophagus tissue and porcine cadavers. Impleo already owns an issued US method Patent to inject bulking agent in the esophagus and plans to generate additional IP in this project.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.