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

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.