Multi-lumen steerable needles for transoral access to lung nodules

描述(申请人提供)：这项提案旨在开发、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来扩大支气管镜的范围，以安全地进入周围肺的位置，用于早期诊断和治疗肺癌。肺癌每年造成的死亡人数比任何其他癌症都多，每年有超过15万美国人死于肺癌。生存取决于早期诊断，而早期诊断需要活检才能确诊。不幸的是，目前获取可疑结节以进行活检的方法要么存在肺塌陷(气胸)的风险，要么无法准确接触到周围肺中不与支气管处相邻的结节，这使得准确获取一半以上肺内的结节往好了说是危险的，往坏了说是不可能的。新系统将利用多腔可控针头的能力，可靠和安全地进入肺内的任何结节，包括外围区域。多腔可控针头由预弯、嵌套的管子组成。每根管子独立旋转和轴向平移，医生可以控制针的曲线形状。拟议的系统将包括支气管镜，通过它可以部署多腔可控针头。要使用该系统，医生首先要引导支气管镜靠近结节。接下来，在图像引导下，多腔可控针会从支气管镜的尖端展开，刺穿支气管管，穿过实质到达结节。与现有的限制沿着支气管行的跨气道设备不同，我们的设备将能够控制肺部的任何地方。此外，使用支气管镜部署的多腔可控针头将降低出血(因为通过图像引导引导可以避免实质内的重大血管)和气胸(因为与经胸针活检不同，我们的设备从不刺穿肺周围的胸膜)的严重风险。其具体目标是(1)开发用于肺部手术的支气管镜部署的多腔可控针头，(2)利用设备硬件和图像引导规划软件构建原型系统，以及(3)通过在体外扩张的猪肺进行CT引导实验来评估该系统的有效性。这个项目汇集了一个多学科团队，他们跨越了实现这些目标所需的专业知识领域，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活生生的体外猪肺。拟议中的新系统将为未来对活体动物、身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、可靠地获取肺部任何部位的结节来早期、明确地诊断肺部，从而提高公众健康。 癌症。一旦多腔可控针头安全到达结节，新设备还将能够通过化疗滴注、消融和近距离放射治疗提供局部治疗。

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.