Research Project
9702064
PROJECT SUMMARY/ABSTRACT The goal of this small business innovation research grant is to develop and commercialize a cost-effective, contrast-assisted intraoperative ureter detection system, which integrates into existing surgical tools to identify ureters in real-time and prevent iatrogenic injuries. 70% of iatrogenic ureteral injuries are detected postoperatively, up to 30 days after hospital discharge. These injuries can cause ureteral obstruction, fistula(e) and eventually renal failure when not repaired immediately, and cost hospitals an average of $30,000 per patient with an added hospitalization time of 4 days. Currently, the only available technologies that assist in ureter detection, including cystoscopy and lighted stents, are costly and have led to additional complications such as reflux anuria and urinary tract infections. The RUD system would be the first unobtrusive and cost- effective alternative with the potential to decrease the incidence of ureteral complications during surgery. In this SBIR project, Briteseed will miniaturize and further prepare its current ureter detection system, and validate its capabilities in both ex vivo and in vivo porcine studies. This rapid ureter detection (RUD) system will use optical technology to non-invasively detect the ureters in real-time and prevent iatrogenic injury during surgery. This system will enable users to detect the ureters using methylene blue (MB), an FDA-approved and clinically utilized dye, as a contrast agent during surgery. No additional tools such as catheters, stents and cystoscopy will be used, therefore avoiding any complications caused by these tools. By preventing ureteral injury through real-time detection, this technology will lead to safer surgical outcomes for patients and lessen the financial burden on healthcare providers. In Phase I of the SBIR, the RUD system was optimized and validated to provide: (a) real-time, automated ureter detection and (b) ability to differentiate between the ureter and surrounding tissues. In Phase II, the RUD system will be modified to integrate into a laparoscopic grasper, and it will be used in pre-clinical validation of the technology, including a head-to-head comparison with ureteral stents. This technology will profoundly affect gynecological procedures, where the ureter is at high risk with no proven detection method currently available to prevent injury.
