SBIR Phase II: An Ingestible, Intraluminal, Bioelectronic Capsule (IBC) for Closed-Loop Diagnosis and Treatment of Gastrointestinal Disorders

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project focuses on a new gastrointestinal therapeutic device supporting multi-modal gastrointestinal measurements and treatment of post-surgical complications. Over 300,000 patients in the US undergo abdominal resection surgery each year. These patients often experience serious complications, such as post-operative ileus, gastrointestinal hemorrhage, and anastomotic leakage, that significantly impact quality of life. The success of this project would not only benefit patients undergoing abdominal surgery and their families, but also would significantly reduce health care expenditures by decreasing the length of hospitalization as well as associated medical resources. Furthermore, this interdisciplinary research brings together academic collaborators from different fields of expertise. The project provides a unique experience and training for engineers and scientists in the fields of neural interface design and medical device experiments, bridging the gap between the engineering and medical communities, as well as promoting and cultivating future neural engineers to focus on developing emerging/unmet diagnostic and therapeutic devices for improving human health. This Small Business Innovation Research (SBIR) Phase II project develops and demonstrates a wireless, miniaturized, intraluminal bioelectronic capsule capable of performing on-demand neuromodulation and multi-modality sensing on the gastrointestinal tract, supporting closed-loop neuromodulation. The device will be tested and characterized on benchtop and also through porcine models to demonstrate its potential for treating and monitoring post-surgical complications. The lengthy process of diagnosing and treating post-surgical complications significantly increases healthcare costs. Costs from hospitalization time alone exceed $2,000 per day for post-operative ileus alone. Additional costs due to prolonged hospitalization time exceed $1.5 billion annually. Rapid detection and treatment of these complications could reduce hospitalization time, accelerate recovery, enable closed-loop therapies, and increase quality of life for patients. The success of this project has the potential to bring disruptive impact and revolution to the current pharmaceutical-based post-surgical management and treatment. In addition, the technology developed during this project may be useful to treat other chronic diseases and injuries that are incurable pharmaceutically. The technique may be used as research tools for investigating the biological mechanisms and new therapeutics for different diseases. 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.