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

该项目更广泛的影响/商业潜力是完全改变关键解剖结构（如输尿管）在手术过程中的识别和保护方式。随着医疗技术的进步和手术使用机器人并通过毫米大小的切口完成，对在手术期间快速轻松地识别体内不同结构的技术的需求不断增加，以提高这些技术的安全性，缩短手术时间并从手术长度和手术并发症的角度降低医疗成本。精确的电刺激产生有针对性的平滑肌结构收缩，使它们立即被外科医生看到，而无需执行复杂和危险的解剖，并消除了对昂贵（和侵入性）产品的需求，如输尿管支架，以保证患者的安全。手术过程中的平滑肌刺激将改变我们现在和未来的手术方式。它可以帮助外科医生通过按下按钮来识别组织结构，帮助确定健康和不健康的组织，并指导临床决策。随着为患者提供高质量护理的需求不断增长，提高手术效率、患者安全性和降低医疗成本的技术将具有很高的需求和重大的商业影响。这一小型企业创新研究（SBIR）第二期项目将通过设计、开发和临床使用创新的平滑肌测量设备，极大地推动手术领域的发展。目前，仅在美国，每年就有超过300万例手术，外科医生花费高达40%的手术时间寻找输尿管等结构，以防止意外损伤，而该结构的损伤导致每年超过30亿美元的医疗保健超支。该二期项目将把一种独特的平滑肌刺激技术带入手术室，使外科医生和患者受益。将设计和构建信号发生器（具有适当的安全功能），测试并与无菌手术工具配对。这些将首先在大型动物模型和计算机模拟研究中进行测试，以确认安全性和有效性，然后将在医院环境中对同意参与的患者进行临床试点研究。该项目的预期结果是使医疗设备系统通过所有人类使用的标准电气安全要求，证明其在临床上有效地帮助外科医生在下腹部/盆腔手术中识别输尿管等结构。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.