Bronchoscopic lung navigation system for accurately excising lung nodules

用于精确切除肺结节的支气管镜肺部导航系统

• 批准号: 10325793
• 负责人: Jayender Jagadeesan
• 金额: $ 32.4万
• 依托单位: NAVIGATION SCIENCES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-02 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10325793
• 关键词: 3D Print; Address; Boston; Bronchoscopes; Cessation of life; Clinical; Collaborations; Couples; Development; Devices; Diagnostic; Doctor of Philosophy; Electromagnetics; Ensure; Equipment; Excision; Family suidae; Future; Goals; Health Care Costs; Hospitals; Image; Image-Guided Surgery; Imaging technology; Incidence; Location; Lung; Lung Neoplasms; Lung nodule; Malignant neoplasm of lung; Measures; Mechanics; Medical center; Metals; Methods; Modernization; Navigation System; Needles; Nodule; Operative Surgical Procedures; Outcome; Patients; Performance; Phase; Positioning Attribute; Procedures; Recurrence; Robotics; Science; Signal Transduction; Small Business Technology Transfer Research; Structure of parenchyma of lung; Surface; Surgeon; Surgical Staplers; Technology; Thoracic Surgical Procedures; Thoracoscopic Surgical Procedures; Time; TimeLine; Tumor Markers; Tumor stage; Validation; Video-Assisted Thoracic Surgery; Visual; Woman; X-Ray Computed Tomography; arm; base; cancer diagnosis; design; image guided; imaging capabilities; innovation; instrument; low dose computed tomography; lung preservation; manufacturing process; minimally invasive; novel; preclinical study; preservation; pulmonary function; research and development; screening; sensor; software development; standard of care; tool; tumor

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.

抽象的 该项目的长期目标是开发和商业化可以准确的导航系统 在肺癌手术期间实时确定边缘。手术目前是早期的护理标准 期肺癌。一个关键的挑战是可靠地识别出小的早期肿瘤，并将其切除 足够的边缘（肿瘤边缘和切除线之间的距离）。太近的边距是 与更高的复发和死亡事件有关。为了应对这一挑战，该团队开发了一个 新的手术程序称为图像引导的视频胸腔镜手术（IVAT），外科医生本地化 并通过使用基准标记（一种小的被动金属）将其标记得分来切除小肺结节 标签称为T-bar，放置在C-ARM CT图像螺旋下。一种新颖的导航技术Navisci™是 开发的是通过使用主动敏感性结节标记（称为J-）来帮助识别和去除肺部肿瘤 酒吧，放置在肿瘤旁边的肺部，可以实时跟踪肿瘤位置并帮助评估 利润。但是，使用J-bar需要术中成像或近似的视觉定位 在肺表面手术期间可能看不到的非常小的肿瘤。 导航科学现在正在开发一个可以用支气管镜定位的肿瘤标记物 在手术过程中不需要CT成像。 I阶段I STTR项目的目的是开发和验证 Navisci-endomarkertm（以下称为内域），可以准确定位小肺肿瘤。这 胚胎标志物将根据计划使用的导航，将肿瘤与肿瘤相邻 诊断CT图像。这将简化临床工作流程，并使医院可以访问此过程 没有先进的术中成像技术。目标1是设计和开发 支气管镜内归因于。 AIM 2是验证工作流程以部署内构的机械稳定性的工作流程， 以及在3D印刷肺幻影，离体猪肺和2个活猪中的内粒子的电隔离。 这个STTR项目是导航科学与杨百翰正在进行的合作者之间的合作 妇女医院（马萨诸塞州波士顿）。拟议的研发项目很重要，因为它解决了重要的 在保留健康的肺功能的同时，准确定位和切除肺结节的问题，这可能 每年受益数千名患者。新颖性在于内域的设计，这将允许 J-bar标记将通过支气管镜准确放置，以便可以轻松地定位小肿瘤并定义 他们在手术期间的边缘。该项目的成功完成将导致创新的破坏性产品 这将提供手术指导，以确保足够的早期肺癌切除 保证金在医疗中心没有任何其他成像设备。