STTR Phase II: Intraoperative Monitoring Device to Detect Bowel Injuries During Laparoscopic Surgical Procedures

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project is significantly reduced patient harm and associated healthcare costs during minimally invasive abdominal laparoscopic or robotic surgery, by improving the early detection of inadvertent injuries to the bowel. There are 15 million laparoscopic abdominal surgeries performed in the U.S. every year. These include hernia repair, hysterectomy, prostate removal, gallbladder removal, all which pose a risk of Injuries to internal organs including the bowel, which can go undetected and lead to life-threatening complications, prolonged recovery, and high financial burden. By enabling real-time recognition of events during surgery, this project offers the potential to reduce repeat operations, intensive care stays, long-term health issues, and death. The impact includes clinical benefits, technological biomedical innovations, improved patient outcomes, improved surgical efficiency and decreased hospitalization costs, as a new system category. This Small Business Technology Transfer (STTR) Phase II project focuses on developing a gas-based sensing system for use during surgery to detect internal bowel injuries. The novel device senses and identifies specific gas compounds that are typically confined to the digestive tract which escape into the abdominal cavity upon bowel injury, identified using unique chemical signatures. The project will evaluate several sensing methods at various concentrations and environmental challenges including smoke, fluctuating temperatures, and varying pressures. The technology development activities include defining detection thresholds and system performance within structured data collection during surgical procedures, and validation and optimization compared to laboratory testing standards to predict their real-world functionality in clinical use. The final objective of the proposed activities are to validate the system in a limited patient study. These milestones will produce a novel system that assists surgical teams identify complications earlier, lower abdominal surgical risks, detect currently undetected or late detected events, in a system validated in a limited patient group under controlled conditions.