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

该项目的广泛影响/商业潜力直接解决了因医源性输尿管损伤而产生的估计32亿美元的医疗负担，这些损伤发生在美国每年进行的300万例腹部和盆腔手术中。Alltrope Medical创造了创新的手术解决方案，直接解决了这种情况，以改善患者的预后并降低手术成本。同素异形体？S装置改善了解剖结构的定位和组织识别，从而减少了损伤的可能性，同时增强了外科医生S减少手术时间的信心。利用平滑肌肉刺激，Alltrope？S StimSite是一种无菌一次性电池供电的设备，可以安全可靠地识别输尿管位置，以避免在这些腹部和盆腔外科手术中受到伤害。输尿管自然收缩，同时将尿液从肾脏排入膀胱。这种平滑肌结构在解剖和挤压过程中有受伤的风险，这是目前的标准手术方法，通过机械方式引起这种收缩，从而在手术中定位输尿管。同素异形体已经证明StimSite？S有能力在不进行手术解剖的情况下引起相同的收缩，从而降低受伤风险，同时显著减少手术时间。这项小企业创新研究(SBIR第一阶段项目)将推动StimSite使用的平滑肌电刺激技术。该项目将改善产品开发和临床对设计操作极限的理解，同时通过与腹腔镜成像系统更好地集成来显示输尿管位置的稳定指示，增加产品的临床实用性。该项目包括三个目标：首先，使用仪表板设备，研究专有的电脉冲波形，以表征不同的波形参数如何影响组织收缩反应。其次，将在猪模型中评估首选波形的性能，以确认独立配置的体内性能。第三，将评估现有的图像处理软件，以跟踪和追踪输尿管收缩，并在输尿管放松后保留在监视器上显示的输尿管位置路线图，不再直接可视化。这三个目标将极大地推动Alltrope的平滑肌电刺激技术平台在当前设备中的使用，并有针对性地在未来在食道、胃和肠道组织识别等方面应用。

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.