SBIR Phase I: Ureter Detection during Minimally Invasive or Robotic Surgery by Electrical Stimulus Evoked Responses

The broader impact/commercial potential of this project directly addresses the estimated $3.2 billion healthcare burden that develops from iatrogenic ureteral injuries that occur across the three million abdominal and pelvic surgeries being performed annually in the United States. Allotrope Medical creates innovative surgical solutions to improve patient outcomes and reduce procedure costs, directly addressing this situation. Allotrope?s devices improve anatomical structure location and tissue identification thereby reducing the potential for injury while enhancing a surgeon?s confidence for reduced procedure time. Using smooth muscle stimulation, Allotrope?s StimSite is a sterile single-use, battery powered device that safely and reliably identifies the ureter location to avoid injury during these abdominal and pelvic surgical procedures. The ureter naturally contracts while draining urine from the kidneys into the bladder. This smooth muscle structure is at risk of injury during dissection and pinching, the current standard surgical method, to mechanically elicit this contraction and thereby locating the ureter during surgery. Allotrope has demonstrated StimSite?s ability to elicit the same contraction without surgical dissection, thereby diminishing the injury risk while also significantly reducing the surgical procedure time. This Small Business Innovation Research (SBIR Phase I project will advance the smooth muscle electrical stimulation technology used in StimSite. The project will improve product development and clinical understanding of the design's operating limits while increasing the product's clinical utility through better integration with the laparoscope's imaging system to display a stable indication of the ureter position. This project encompasses three objectives: First, using an instrumented breadboard device, the proprietary electrical pulse waveform will be studied characterizing how varying the waveform parameters affect tissue contraction responses. Second, the performance of the preferred waveform will be evaluated in a porcine model to confirm in-vivo performance of a stand-alone configuration. Third, available image processing software will be evaluated to track and trace the ureter contraction and retain a road-map of the ureter position displayed on the monitor after the ureter has relaxed and is no longer directly visualized. These three objectives will substantially advance Allotrope's smooth muscle electrical stimulation technology platform for the current device use and targeted future applications in esophageal, stomach and bowel tissue identification, etc.