Multi-lumen steerable needles for transoral access to lung nodules

描述（由申请人提供）：本提案旨在开发、建立和评估一种新的医疗系统，该系统将使用多腔可导向针将支气管镜的范围扩展到外周肺的安全位置，以在早期诊断和治疗肺癌。肺癌每年造成的死亡人数超过任何其他癌症，每年有超过15万美国人死于肺癌。生存取决于早期诊断，这需要活检来确定。不幸的是，目前用于活检可疑结节的方法要么有肺萎陷（气胸）的风险，要么无法准确到达不靠近支气管的外周肺结节，这使得准确到达超过一半的肺结节是危险的，或者是不可能的。新系统将利用多腔可操纵针头的能力，可靠安全地进入肺中的任何结节，包括外周区。多腔可操纵针由预弯曲的嵌套管组成。独立旋转和轴向平移每个管允许医生控制针的曲线形状。拟议的系统将包括支气管镜，通过它可以部署多腔可操纵针头。要使用该系统，医生将首先引导支气管镜靠近结节。接下来，使用图像引导，多腔可操纵针将从支气管镜尖端部署，刺穿支气管，并通过实质移动到结节。不同于现有的只能沿着支气管移动的经气道设备，我们的设备将能够在肺的任何地方移动。此外，在支气管镜下使用多腔导向针可以降低出血和气胸的严重风险（因为在图像引导下可以避免软组织中的重要血管）（因为与经胸穿刺活检相比，我们的设备从不穿刺肺周围的胸膜）。具体目标是：(1)开发用于肺部手术的支气管镜部署的多腔可操纵针，(2)用设备硬件和图像引导规划软件构建原型系统，以及(3)通过ct引导实验在充气的离体猪肺中评估系统的有效性。该项目汇集了一个多学科团队，跨越了实现这些目标所需的专业领域，包括心胸外科、支气管镜检查、放射学、机械工程和计算机科学方面的专业知识。我们将在北卡罗来纳大学教堂山分校进行评估实验，在用于培训外科医生和住院医生的模拟器中使用动画的离体猪肺。这个被提议的新系统将为未来对活体动物、尸体以及最终对人类的研究奠定基础。这项拟议的研究有可能通过低风险，可靠地获得肺中任何地方的结节，以早期明确诊断肺，从而增强公众健康

DESCRIPTION (provided by applicant): This proposal aims to develop, build, and assess a new medical system that will use a multi-lumen steerable needle to extend the reach of a bronchoscope to safely access locations in the peripheral lung for diagnosing and treating lung cancer at earlier stages. Lung cancer is responsible for more deaths per year than any other cancer, with more than 150,000 Americans dying from it each year. Survival depends on early diagnosis, which requires biopsy to be definitive. Unfortunately, current approaches for accessing suspicious nodules for biopsy either risk lung collapse (pneumothorax) or are unable to accurately reach nodules in the peripheral lung not adjacent to a bronchial tube, making it dangerous at best, or impossible at worst, to accurately access nodules in over half the lung. The new system will harness the capabilities of multi-lumen steerable needles to reliably and safely access any nodule in the lung, including in the peripheral zone. Multi-lumen steerable needles consist of pre-curved, nested tubes. Independently rotating and axially translating each tube allows a physician to control the needle's curvilinear shape. The proposed system will include the bronchoscope through which multi-lumen steerable needles can be deployed. To use the system, a physician will first guide a bronchoscope close to the nodule. Next, using image-guidance, the multi-lumen steerable needle will deploy from the bronchoscope's tip, pierce the bronchial tube, and maneuver through the parenchyma to the nodule. Unlike existing trans-airway devices that are restricted to moving along bronchial tubes, our device will be able to steer anywhere in the lung. Furthermore, using multi-lumen steerable needles deployed from a bronchoscope will decrease the serious risks of bleeding (since significant vessels in the parenchyma can be avoided by image-guided steering) and pneumothorax (since, in contrast to transthoracic needle biopsy, our device never punctures the pleura around the lung). The specific aims are to (1) develop a bronchoscope-deployed multi-lumen steerable needle for lung procedures, (2) build a prototype system with device hardware and image-guidance planning software, and (3) assess the effectiveness of the system via CT-guided experiments in inflated, ex vivo porcine lungs. This project brings together a multidisciplinary team that spans the areas of expertise necessary to accomplish these aims, including expertise in cardiothoracic surgery, bronchoscopy, radiology, mechanical engineering, and computer science. We will conduct the evaluation experiments at the University of North Carolina at Chapel Hill using animated, ex vivo porcine lungs in a simulator that is used for training surgeons and residents. The proposed new system will lay the groundwork for future studies with live animals, cadavers, and, ultimately, humans. This proposed research has the potential to enhance public health by enabling low-risk, reliable access to nodules anywhere in the lung for early-stage, definitive diagnosis of lung cancer. Once the multi-lumen steerable needles safely reach the nodule, the new device will also be able to deliver local therapy via chemotherapy instillation, ablation, and brachytherapy.