SBIR Phase I: Intraoperative monitoring device to detect bowel injuries during laparoscopic surgical procedures

This broader impacts/commercial potential of this SBIR Phase I project is to enhance patient safety by addressing the most devastating and costly risk associated with robotic-assisted and standard laparoscopic surgical procedures – undetected bowel perforation. More than 15 million such procedures, including hysterectomy, cholecystectomy, hernia repair, prostatectomy, oophorectomy and others, are performed annually. While the incidence of undetected bowel perforation is relatively low at 0.3 – 1.0%, the consequences for more than 40,000 patients annually are severe, and the incremental costs of caring for those patients substantial. Detection of inadvertent bowel perforation during the initial surgery would enable surgeons to effect repair at that time, avoiding unnecessary patient suffering, billions in associated costs and a 5% mortality rate. Those patients who do not die are subjected to multiple corrective surgeries, extensive antibiotic treatment and potentially lengthy intensive care convalescence. Patient safety concerns and the significant cost of corrective care, which can easily exceed $100,000 per patient, dictate the need for a low-cost solution. The proposed project will advance the development of intraoperative detection of bowel perforation, allowing for immediate repair and avoidance of negative outcomes. This can be accomplished by the detection of gases released from the bowel when it is perforated and alerting the surgeon to the presence of the perforation. This innovation would be applicable to more than 49,000 operating suites in the U.S. and represent a potential addressable market of $750 million annually. The proposed SBIR Phase I project will be to advance the development of an intraoperative detection of bowel perforation, including: 1) experimentation relative to gas species selection and detection methodology / modality; 2) identification and optimization of detection ranges; 3) development of controls to ensure against false positive and negative results. Benchtop and in-vivo testing is proposed to determine repeatability and reliability regarding device efficacy. A Potential Failure Modes Effects Analysis (PFMEA) will be utilized to highlight technical risks. The project will also explore the cost-performance trade space to create a new patient safety measure in laparoscopic and robotic procedures. 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.