SBIR-STTR Award

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.

The broader impact/commercial potential of this project is to completely change how critical anatomic structures such as the ureter are identified and protected during surgery. As surgical technology advances and procedures are done using robots and through millimeter-sized incisions, there is an ever-increasing need for technology that quickly and easily identifies different structures in the body during surgery to increase the safety of these techniques, shorten the operations and decrease healthcare costs both from a procedure length standpoint as well as surgical complications. Precise electrical stimulation that generates targeted smooth muscle structure contractions make them immediately visible to the surgeon without needing to perform complex and risky dissections, and eliminates the need for costly (and invasive) products such as ureteral stents to keep patients safe. Smooth muscle stimulation during surgery will change how we operate both today, and in the future. It can help surgeons identify tissue structures with the push of a button, help determine healthy and unhealthy tissues from each other, and can guide clinical decision making. With an ever-increasing need to deliver quality care to patients, technology that increases surgical efficiency, patient safety and decreases healthcare costs will have high demand and significant commercial impact. This Small Business Innovation Research (SBIR) Phase II project will greatly advance the field of surgery through design, development and clinical use of an innovative smooth muscle stimulation device. Surgeons currently spend up to 40% of their operating time looking for structures such as the ureter to prevent accidental injury in over 3 million operations done each year in the US alone, and injuries to this structure accounts for over $3 billion in annual healthcare over-spending. This Phase II project will bring a unique smooth muscle stimulation technology into the operating room to benefit surgeons and patients. A signal generator will be designed and built (with safety features in place), tested, and paired with sterile surgical instruments. These will be tested first in large animal models as well as in-silico studies to confirm safety and efficacy, and then a clinical pilot study will be performed in the hospital setting in patients that consent to participate. The anticipated result of this project is to have a medical device system that passes all standard electrical safety requirement for human use that is shown to be clinically effective in assisting surgeons in identification of structures such as the ureter during lower abdominal/pelvic operations. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.