SBIR-STTR Award

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 continue the development of a 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 hospitals. In Phase I of the SBIR, the RUD system will be 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 surgical tools most commonly used near the ureters during gynecological procedures (i.e. thermal ligature devices, grasper/dissectors). This technology will profoundly affect gynecological procedures, where the ureter is at high risk with no highly adopted detection method currently available to prevent injury.

Public Health Relevance Statement:
PROJECT NARRATIVE Studies have shown that 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. This SBIR project aims to develop and commercialize the Rapid Ureter Detection (RUD) system which would be the first unobtrusive and cost-effective alternative with the potential to decrease the incidence of ureteral complications during surgery. 

Project Terms:
Accidental Injury; Adopted; Affect; Algorithms; Anatomy; Anuria; Automation; base; Catheterization; Catheters; Characteristics; Contrast Media; cost; cost effective; Custom; Cystoscopy; Data; design; Detection; Development; Devices; Dyes; Excision; Family suidae; FDA approved; Fistula; Generations; Goals; Gynecologic Surgical Procedures; high risk; Hospital Costs; Hospitalization; Hospitals; Housing; improved; in vivo; Incidence; injured; Injury; Kidney Failure; Kinetics; Lead; Life; Ligature; Light; Medical Device; Methods; Methylene blue; Miniaturization; Morphologic artifacts; Motion; Operative Surgical Procedures; Optics; Patient-Focused Outcomes; Patients; Pelvis; Phase; prevent; Prevention; Procedures; Process; prototype; Reflux; repaired; Reporting; signal processing; Signal Transduction; Small Business Innovation Research Grant; Speed; Staining method; Stains; Stents; Structure; System; Systems Analysis; Technology; Testing; Time; Tissues; tool; Ultrasonics; Ureter; Ureteral obstruction; Urinary tract infection; Work

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.

Thesaurus Terms:
Adoption; Affect; Algorithmic Software; Anuria; Base; Blood Vessels; Catheters; Clinical; Colorectal; Complex; Computer Software; Consult; Contrast Media; Cost; Cost Effective; Cystoscopy; Design; Detection; Development; Devices; Dyes; Effectiveness; Family Suidae; Fda Approved; Feedback; Fistula; Goals; Graphical User Interface; Gynecologic Surgical Procedures; Gynecology; Head; Head-To-Head Comparison; Health Care Costs; Health Personnel; Healthcare Systems; High Risk; Histologic; Hospital Costs; Hospitalization; Hospitals; Housing; Hysterectomy; Iatrogenesis; Imagery; In Vivo; Incidence; Infection; Information Display; Injury; Inpatients; Interruption; Intervention; Jaw; Kidney Failure; Length Of Stay; Location; Methods; Methylene Blue; Miniaturization; Miniaturize; Minimally Invasive; Modeling; Morphologic Artifacts; Operative Surgical Procedures; Optical Sensor; Optics; Patient-Focused Outcomes; Patients; Peritoneal; Phase; Postoperative Period; Pre-Clinical; Prevent; Procedures; Process; Programs; Prototype; Recovery; Reflux; Research; Resolution; Risk; Running; Safety; Signal Transduction; Site; Small Business Innovation Research Grant; Speed; Stents; Success; Surgeon; Surgery Outcome; System; System Architecture; Tactile; Techniques; Technology; Technology Validation; Testing; Time; Tissues; Tool; Translating; Ureter; Ureteral Obstruction; Urinary Tract Infection; Urologic; Usability; Validation; Visualization Software;