The broader impact of this Small Business Innovation Research (SBIR) Phase I project addresses the clinical needs for tissue approximation and closure of large gastrointestinal defects in endoscopic surgery through the development of a novel image-guided full-thickness suturing device that is simple and easy to use while cost-effective. Full-thickness gastrointestinal defects such as perforation, anastomotic leak, and fistula are severe conditions caused by various types of pathologies. They 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 project, if successful, will lead to demonstrating the feasibility of a novel, low cost, image-guided suturing device that is simple and intuitive to use. Currently, no good solutions exist for 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 on the market is very cumbersome, difficult to use, and its high cost often precludes usage. The technical innovation of the proposed device comprises a circular needle and a novel needle drive mechanism which allows for a simplified suturing technique. The device is single use, disposable, and an attachment to an endoscope (such as colonoscope, gastroscope). The technical goals of this project focus on developing and building a proof of concept prototype which includes custom needle and needle drive mechanism, suture anchors, and suture exchange mechanism; testing the prototype in a gastric model; proving the simplicity of this novel suturing technique through a physician feedback study; and validating the viability and scalability of design features for a commercialized product at a low cost. 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.
