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.

摘要 该项目的长期目标是开发和商业化一种导航系统， 在肺癌手术期间实时确定边缘。手术目前是早期糖尿病的标准治疗方法。 晚期肺癌一个关键的挑战是可靠地识别小的早期肿瘤并切除它们， 足够的边缘（肿瘤边缘与切除线之间的距离）。差距太小 与较高的复发率和死亡率相关。为了应对这一挑战，该团队开发了一个 一种新的外科手术，称为图像引导视频胸腔镜手术（iVATS），其中外科医生定位 并切除小的肺结节， T形杆标签，置于C形臂CT图像引导下。一种新的导航技术，NaviSci™， 开发用于通过使用称为J-的主动传感结节标记来帮助识别和去除肺肿瘤。 棒，即放置在肺部肿瘤旁边，可以实时跟踪肿瘤位置并帮助评估 利润率然而，使用J形杆需要术中成像或近似视觉定位， 非常小的肿瘤，在手术过程中可能无法从肺表面看到。 导航科学公司正在开发一种肿瘤标记物，可以用支气管镜定位， 手术期间不需要CT成像。第一阶段STTR项目的目标是开发和验证 NaviSci-EndoMarkerTM（以下称为EndoMarker）用于准确定位肺部小肿瘤。的 使用支气管镜根据计划的导航将EndoMarker定位在肿瘤附近， 诊断CT图像。这将简化临床工作流程，并使医院能够使用该程序 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。目的2是确认展开EndoMarker的工作流程、机械稳定性， 以及EndoMarker在3D打印肺体模、离体猪肺和2头活猪中的电隔离。 这个STTR项目是导航科学与布里格姆大学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）。拟议的研发项目意义重大，因为它涉及一个重要的 在保持健康肺功能的同时精确定位和切除肺结节的问题， 每年有数千名患者受益。创新之处在于EndoMarker的设计， 通过支气管镜准确放置J形棒标记，以便轻松定位小肿瘤并确定 在手术过程中切缘这个项目的成功完成将导致一个创新的颠覆性产品 这将提供手术指导，以确保充分切除早期肺癌， 医疗中心无需任何额外的成像设备即可获得利润。