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

Impleo Medical, Inc., St. Paul MN

Investigators

Abstract

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.