Custom Sensor Manufacturing and Regulatory Preparation Assistance for Novel Intraoperative Ureter Detection Device

PROJECT SUMMARY/ABSTRACT The goal of this small business innovation research grant is to commercialize a cost-effective and contrast-free intraoperative ureter detection system, which integrates into a laparoscopic vessel sealing device 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. Additionally, for women with pelvic inflammatory conditions or endometriosis, gynecologic surgery is further complicated due to lack of critical structure visualization. Currently, the only available technologies that assist in ureter injury detection, including cystoscopy and lighted stents, are costly and/or time-consuming and have led to additional complications such as reflux anuria and urinary tract infections. The Briteseed system would be the first unobtrusive, easy to use and cost-effective alternative with the potential to decrease the incidence of ureteral complications during pelvic surgery. In this CRP project, Briteseed will finalize steps to prepare its hyperspectral imaging based rapid ureter detection (HSI-RUD) laparoscopic vessel sealer for commercialization. The HSI-RUD uses transmission based optics to non-invasively detect the ureters in real-time without any contrast agent. Preventing ureteral injury through real-time detection will lead to better outcomes for patients and lessen the financial burden on the healthcare system. In Phase I of the SBIR, the technology was optimized and validated to provide: (a) real-time, automated ureter detection and (b) the ability to differentiate between the ureter and surrounding tissues. In Phase II, the RUD system was integrated into a laparoscopic grasper and used in pre-clinical studies to receive clinician feedback on the user interface. Since the end of Phase II, the company has successfully, independently integrated an optical subsystem into a vessel sealer, which has created significant interest from strategics to integrate our technology into their tools through co-development. Additionally, the company has engaged with the FDA to understand the regulatory pathway of the HSI-RUD device. The technology must undergo late stage activities to prepare for a de novo FDA submission and a high-cost manufacturing step before it can be commercialized by either a strategic partner or Briteseed independently and made available in operating rooms for gynecological procedures, where the ureter is at risk with no proven detection method currently available to prevent injury.