BRITESEED, LLC — Department of Health and Human Services SBIR Phase II: NICHD

Description

PROJECT SUMMARY ABSTRACT The goal of this small business innovation research grant is to develop and commercialize a cost effectivecontrast assisted intraoperative ureter detection systemwhich integrates into existing surgical tools to identify ureters in real time and prevent iatrogenic injuriesof iatrogenic ureteral injuries are detected postoperativelyup todays after hospital dischargeThese injuries can cause ureteral obstructionfistula eand eventually renal failure when not repaired immediatelyand cost hospitals an average of $per patient with an added hospitalization time ofdaysCurrentlythe only available technologies that assist in ureter detectionincluding cystoscopy and lighted stentsare costly and have led to additional complications such as reflux anuria and urinary tract infectionsThe RUD system would be the first unobtrusive and costeffective alternative with the potential to decrease the incidence of ureteral complications during surgeryIn this SBIR projectBriteseed will miniaturize and further prepare its current ureter detection systemand validate its capabilities in both ex vivo and in vivo porcine studiesThis rapid ureter detectionRUDsystem will use optical technology to non invasively detect the ureters in real time and prevent iatrogenic injury during surgeryThis system will enable users to detect the ureters using methylene blueMBan FDA approved and clinically utilized dyeas a contrast agent during surgeryNo additional tools such as cathetersstents and cystoscopy will be usedtherefore avoiding any complications caused by these toolsBy preventing ureteral injury through real time detectionthis technology will lead to safer surgical outcomes for patients and lessen the financial burden on healthcare providersIn Phase I of the SBIRthe RUD system was optimized and validated to provideareal timeautomated ureter detection andbability to differentiate between the ureter and surrounding tissuesIn Phase IIthe RUD system will be modified to integrate into a laparoscopic grasperand it will be used in pre clinical validation of the technologyincluding a head to head comparison with ureteral stentsThis technology will profoundly affect gynecological procedureswhere the ureter is at high risk with no proven detection method currently available to prevent injury PROJECT NARRATIVE This SBIR project aims to develop and commercialize a Rapid Ureter DetectionRUDsystem which would be the first universalunobtrusive and cost effective ureter detection technology with the potential to decrease the incidence of ureteral complications during minimally invasive gynecological surgeryStudies have shown thatof iatrogenic ureteral injuries are detected postoperativelyup todays after hospital dischargeand these injuries can cause ureteral obstructionfistula eand eventually renal failure when not repaired immediatelyFurtherthey can cost hospitals an average of $per patient with an added hospitalization time ofdays !