Bronchoscopic lung navigation system for accurately excising lung nodules

摘要 该项目的长期目标是开发一种能够准确地 在肺癌手术过程中实时确定边缘。手术是目前早期治疗的标准。 肺癌分期。一个关键的挑战是可靠地识别早期的小肿瘤，并用 足够的切缘(肿瘤边缘与切除线之间的距离)。差距太小就是 与较高的复发率和死亡率相关。为了应对这一挑战，这个团队开发了一种 一种新的外科手术，称为影像引导电视胸腔镜术(IVATS)，外科医生在这种手术中定位 并通过使用基准标记(一种小的被动金属)经皮标记来切除微小的肺结节 一种名为T-bar的标签，放置在C臂CT图像引导下。一种新的导航技术--NaviSci™ 开发的目的是通过使用一种名为J-1的主动感测结节标志物来帮助识别和切除肺部肿瘤 Bar，它被放置在紧挨着肿瘤的肺部，可以实时跟踪肿瘤的位置并帮助评估 利润率。然而，J-Bar的使用需要术中成像或近似的视觉定位 在手术中从肺表面看不到的非常小的肿瘤。 导航科学公司现在正在开发一种可以用支气管镜定位的肿瘤标记物，它可以 手术中不需要CT成像。此第一阶段STTR项目的目标是开发和验证 NaviSci-EndoMarkerTM(以下称为EndoMarker)可精确定位小肺部肿瘤。这个 EndoMarker将根据计划使用的导航，通过支气管镜定位在肿瘤附近 诊断CT图像。这将简化临床工作流程，并使医院能够访问该程序 没有先进的术中成像技术。目标1是设计和开发 支气管镜EndoMarker。目标2是验证部署EndoMarker的工作流程、机械稳定性、 以及在3D打印的肺模型、体外猪肺和2头活猪中电隔离EndoMarker。 这个STTR项目是导航科学和Brigham和 妇女医院(马萨诸塞州波士顿)。拟议的研发项目意义重大，因为它解决了一个重要的 在保持健康肺功能的同时准确定位和切除肺结节的问题，这可能 每年使数以千计的患者受益。新奇之处在于EndoMarker的设计，它将允许 通过支气管镜准确放置J-Bar标记物，以便它可以容易地定位小肿瘤并确定 手术期间的利润率。该项目的成功完成将带来一种创新的颠覆性产品 这将为确保早期肺癌以可接受的方式充分切除提供外科指导。 医疗中心无需任何额外的成像设备即可获得利润率。

ABSTRACT The long-term goal of this project is to develop and commercialize a navigation system that can accurately determine margins in real-time during surgery for lung cancer. Surgery is currently the standard of care for early stage lung cancer. A critical challenge is to reliably identify small, early-stage tumors and resect them with sufficient margins (distance between the edge of tumor and the line of resection). Too close a margin is associated with a higher incidence of recurrence and death. To address this challenge, this team developed a new surgical procedure called image-guided video thoracoscopic surgery (iVATS), in which the surgeon localizes and resects small lung nodules by marking them percutaneously using a fiducial marker, a small passive metal tag called T-bar, placed under C-arm CT image-guidance. A novel navigation technology, NaviSci™, was developed to aid in identifying and removing lung tumors by using an active sensing nodule marker, called J- Bar, that is placed in the lung just next to the tumor and can track the tumor position in real-time and help assess margins. However, use of the J-Bar requires either intraoperative imaging or approximate visual positioning of very small tumors that may not be visible during surgery from the lung surface. Navigation Sciences is now developing a tumor marker that can be positioned with a bronchoscope and does not require CT imaging during surgery. The objective of this Phase I STTR project is to develop and validate the NaviSci-EndoMarkerTM (called EndoMarker hereafter) to accurately localize small lung tumors. The EndoMarker will be positioned adjacent to the tumor with a bronchoscope based on navigation planned using diagnostic CT images. This will simplify the clinical workflow and make this procedure accessible to hospitals that do not have advanced intra-operative imaging technologies. Aim 1 is to design and develop the bronchoscopic EndoMarker. Aim 2 is to validate the workflow for deploying the EndoMarker, mechanical stability, and electrical isolation of the EndoMarker in a 3D printed lung phantom, ex vivo porcine lungs and 2 live pigs. This STTR project is a collaboration between Navigation Sciences and ongoing collaborators at the Brigham and Women’s Hospital (Boston, MA). The proposed R&D project is significant since it addresses an important problem of accurately localizing and resecting lung nodules while preserving healthy lung function, which could benefit thousands of patients each year. The novelty lies in the design of the EndoMarker, which will allow the J-Bar marker to be placed accurately via a bronchoscope so that it can readily localize small tumors and define their margins during surgery. Successful completion of this project will result in an innovative disruptive product that will provide surgical guidance to ensure sufficient resection of early-stage lung cancer with acceptable margins without any additional imaging equipment at the medical center.