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

SBIR 第一阶段：通过电刺激诱发反应进行微创或机器人手术期间的输尿管检测

• 批准号: 1746570
• 负责人: Albert Huang
• 金额: $ 22.48万
• 依托单位: Allotrope Medical
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1746570&HistoricalAwards=false
• 关键词: SBIR; Phase; Ureter; Detection; during

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.

该项目的广泛影响/商业潜力直接解决了美国每年300万例腹部和骨盆手术中因医源性输尿管损伤而产生的约32亿美元的医疗负担。同种异体医疗公司创造了创新的手术解决方案，以改善患者的治疗效果并降低手术成本，直接解决了这种情况。同素异形体吗?S装置改善了解剖结构定位和组织识别，从而减少了受伤的可能性，同时提高了外科医生的工作效率。S置信度，减少程序时间。使用平滑肌刺激，同素异形体？StimSite是一种一次性使用的无菌电池供电设备，它可以安全可靠地识别输尿管位置，避免在腹部和骨盆手术过程中受伤。输尿管在将尿液从肾脏排入膀胱时自然收缩。在解剖和挤压过程中，这种平滑肌结构有损伤的危险，目前的标准手术方法是机械地引起这种收缩，从而在手术中定位输尿管。同素异形体已经证明了StimSite？在不进行手术剥离的情况下也能引起同样的收缩，从而降低了损伤风险，同时也显著缩短了手术时间。这项小企业创新研究（SBIR）第一阶段项目将推进StimSite中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限制的理解，同时通过更好地与腹腔镜成像系统集成以显示稳定的输尿管位置指示，增加产品的临床实用性。该项目包括三个目标：首先，使用仪表面包板设备，研究专有的电脉冲波形，表征波形参数的变化如何影响组织收缩响应。其次，优选波形的性能将在猪模型中进行评估，以确认独立配置的体内性能。第三，评估可用的图像处理软件，跟踪和追踪输尿管收缩，并保留输尿管位置的路线图，在输尿管放松，不再直接可视化后显示在监视器上。这三个目标将大大推进Allotrope的平滑肌电刺激技术平台的当前设备使用和有针对性的未来应用在食管，胃和肠组织识别等。