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 II期项目的更广泛/商业影响提议开发一种用于治疗胃食管反流疾病（GERD）的最小侵入性装置。 GERD是美国最常见的胃肠道诊断，遭受了约26％的成年美国人（6000万人），破坏了他们的睡眠，生产力和生活质量，并导致其他胃肠道疾病。尽管有治疗，大约有三分之一的GERD患者继续患有症状。此外，当前处方药的长期使用具有副作用和风险。当前的手术解决方案是侵入性的，昂贵的，并且具有巨大的风险。拟议的注射系统通过将治疗方法安全地注入食道，降低医疗保健成本，改善患者的生活质量并可能降低其他胃肠道疾病的发生率，从而为GERD提供了侵入性和昂贵的治疗方法。该SBIR II期项目将开发一个内窥镜注射系统，以一致地注射散装剂，将散装剂注射到下食管下的粘膜下组织平面。这项技术包括一种控制注射深度的新型系统，并将针头引导到所需的粘膜下组织。该项目将优化针对粘性溶液注入的针头和相关的引导系统，尤其是散装剂，在下食管下会产生粘膜下组织膨胀，并最终防止胃食管反流。这将是第一个在盐水飞行员注射的帮助下使用双管腔注射针的系统。 该项目将进一步探索最终歧管住房的设计空间，并快速迭代3D打印原型。该奖项反映了NSF的法定任务，并且使用基金会的知识分子优点和更广泛的影响评估标准，认为值得通过评估来获得支持。