SBIR Phase II: Novel Image Guided Suturing System For Endoscopic Surgery

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is the development of a novel image-guided full-thickness suturing system that is simple, easy to use, and cost-effective for gastrointestinal (GI) defects. These issues are more likely to require intensive care and a long hospital stay and have high rates of morbidity and mortality. Managing gastrointestinal defects endoscopically has obvious advantages over surgical intervention, including shorter hospital stays, reduced post procedure pain, faster recovery, and reduced total cost of care. The proposed technology is single-use, disposable, and attached to an endoscope (such as colonoscope, gastroscope), for better patient outcomes. This Small Business Innovation Research (SBIR) Phase II project will advance the development of a novel, low-cost, image-guided suturing device for flexible endoscopes simple and intuitive to use. Currently, no good solutions exist for endoscopic tissue approximation and closure of large gastrointestinal (GI) defects. Endoscopic clips are only effective for mucosa closure and small size defects and the only endoscopic suturing device is considered cumbersome, difficult to use, and expensive. The technical innovation of the proposed device comprises a circular needle and a novel needle drive mechanism for a simplified suturing technique. This project will be specifically focused on the advancement of the technology, product development, design verification and validation of the device. 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.