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

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The broader impact/commercial potential of this project is to completely change how criticalanatomic structures such as the ureter are identified and protected during surgery. As surgicaltechnology advances and procedures are done using robots and through millimeter-sizedincisions, there is an ever-increasing need for technology that quickly and easily identifiesdifferent 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 standpointas well as surgical complications. Precise electrical stimulation that generates targeted smoothmuscle structure contractions make them immediately visible to the surgeon without needingto 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 duringsurgery will change how we operate both today, and in the future. It can help surgeons identifytissue structures with the push of a button, help determine healthy and unhealthy tissues fromeach other, and can guide clinical decision making. With an ever-increasing need to deliverquality care to patients, technology that increases surgical efficiency, patient safety anddecreases healthcare costs will have high demand and significant commercial impact.This Small Business Innovation Research (SBIR) Phase II project will greatly advance the field ofsurgery through design, development and clinical use of an innovative smooth musclestimulation device. Surgeons currently spend up to 40% of their operating time looking forstructures such as the ureter to prevent accidental injury in over 3 million operations done eachyear in the US alone, and injuries to this structure accounts for over $3 billion in annualhealthcare over-spending. This Phase II project will bring a unique smooth muscle stimulationtechnology into the operating room to benefit surgeons and patients. A signal generator will bedesigned and built (with safety features in place), tested, and paired with sterile surgicalinstruments. These will be tested first in large animal models as well as in-silico studies toconfirm safety and efficacy, and then a clinical pilot study will be performed in the hospitalsetting in patients that consent to participate. The anticipated result of this project is to have amedical device system that passes all standard electrical safety requirement for human use thatis shown to be clinically effective in assisting surgeons in identification of structures such as theureter 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.