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

SBIR第一期：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: 1819548
• 负责人: Juliana Elstad
• 金额: $ 22.5万
• 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: 2018
• 资助国家: 美国
• 起止时间: 2018-06-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1819548&HistoricalAwards=false
• 关键词: SBIR; Phase; Endoscopic; injection; device

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.

该SBIR I期项目旨在开发一种微创器械，通过将专利物质安全地注射到食管底部，可用于治疗胃食管反流病（GERD）。 胃食管反流病是美国最常见的胃肠道诊断，困扰着约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患者继续遭受症状，尽管目前可用的药物治疗。此外，长期使用目前处方的药物有副作用和风险。目前的手术解决方案是侵入性的，昂贵的，并带来重大风险。预计所提出的注射系统能够实现针对GERD的新颖的、侵入性较小且成本较低的治疗，从而降低总体医疗保健成本并预防或降低其他胃肠道疾病的发生率。鉴于GERD的巨大市场规模和深刻的临床需求，该项目直接解决了为GERD患者开发此类治疗的关键障碍。它有可能显着改善对这种常见疾病的治疗，成为护理标准，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，用于将膨胀剂一致地多次注射到食管下部的粘膜下组织平面中。该技术的核心是一种新型注射系统，该系统利用抽吸口抓住食管壁并将针尖引导到所需的附着组织的粘膜下深度。针和针引导系统的设计将针对粘性溶液的注射进行优化，并将用于注射填充剂，在食管下部产生粘膜下组织隆起，最终防止胃食管反流。申报器械在准确引导粘膜下注射至所需组织平面的能力方面具有独特性。这将是第一个使用真空辅助向粘膜下空间进行靶向注射的系统。将采用快速迭代3D打印原型设计来优化针导几何形状和设计。将在猪尸体食管组织和猪尸体的多个样本中测试系统注射的重复性。Impleo已经拥有一项已颁发的美国方法专利，用于在食道中注入膨胀剂，并计划在该项目中产生更多的IP。该奖项反映了NSF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。