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

SBIR II期：用于食管粘膜下注射填充剂治疗胃食管反流病的内窥镜注射装置

• 批准号: 1949263
• 负责人: Juliana Elstad
• 金额: $ 75万
• 依托单位: Impleo Medical, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-15 至 2022-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1949263&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Endoscopic; injection

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.

该 SBIR 二期项目的更广泛/商业影响旨在开发一种用于治疗胃食管反流病 (GERD) 的微创设备。 GERD 是美国最常见的胃肠道疾病，影响约 26% 的美国成年人（6000 万人），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。尽管接受了治疗，大约三分之一的胃食管反流病患者仍然有症状；此外，长期使用现有处方药物有副作用和风险。目前的手术解决方案是侵入性的、成本高昂且风险巨大。所提出的注射系统通过安全地将治疗药物注射到食管底部，为胃食管反流病提供了一种侵入性较小且成本较低的治疗方法，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。该 SBIR 二期项目将开发一种内窥镜注射系统，用于将填充剂持续多次注射到下食道的粘膜下组织平面中。该技术包括一个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，特别是一种填充剂，可在食管下段产生粘膜下组织膨出，并最终防止胃食管反流。这将是第一个在盐水先导注射辅助下使用双腔注射针的系统。 该项目将通过快速迭代 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智力价值和更广泛的影响审查标准进行评估，被认为值得支持。