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Multi-lumen steerable needles for transoral access to lung nodules

用于经口腔进入肺结节的多腔可操纵针

基本信息

批准号：
8744690
负责人：
Ron Alterovitz
金额：
$ 17.6万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-30 至 2016-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8744690
关键词：
Ablation American Animals Area Biopsy Blood Vessels Brachytherapy Bronchoscopes Bronchoscopy Cadaver Caliber Cessation of life Chest Tubes Clinical Computer software Devices Diagnosis Early Diagnosis Early treatment Effectiveness Engineering Ensure Environmental air flow Evaluation Family suidae Funding Mechanisms Future Hemorrhage Human Image Life Local Therapy Location Lung Lung nodule Malignant Neoplasms Malignant neoplasm of lung Mechanics Medical Methods Modeling Motion Motor Needle biopsy procedure Needles Nodule North Carolina Operative Surgical Procedures Patients Perfusion Peripheral Physicians Pleura Pneumothorax Positron-Emission Tomography Procedures Public Health Puncture procedure Radiofrequency Interstitial Ablation Radiology Specialty Research Risk Rotation Shapes Site Solutions Staging Structure Surgeon Survival Rate System Technology Thoracoscopic Surgical Procedures Training Translating Translations Tube Universities Work X-Ray Computed Tomography base cancer site chemotherapy clinical application clinically relevant computer science design high reward high risk imaging Segmentation instrument low-dose spiral CT minimal risk minimally invasive multidisciplinary novel prototype public health relevance research study respiratory

项目摘要

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.

描述（由申请人提供）：本提案旨在开发、构建和评估一种新的医疗系统，该系统将使用多腔可控针来扩展支气管镜的范围，以安全进入外周肺中的位置，从而在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，这需要活检才能确定。不幸的是，目前用于接近可疑结节进行活检的方法存在肺萎陷（气胸）的风险，或者不能准确地到达不邻近支气管的外周肺中的结节，这使得在最好的情况下危险，或者在最坏的情况下不可能准确地接近超过一半的肺中的结节。新系统将利用多腔可操纵针的能力，可靠、安全地进入肺中的任何结节，包括外周区。多腔可控针由预弯、嵌套管组成。独立地旋转和轴向平移每个管允许医生控制针的曲线形状。申报系统将包括支气管镜，可通过支气管镜展开多腔可控针。为了使用该系统，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的尖端展开，刺穿支气管，并通过实质移动到结节。不像现有的经气道装置，这些装置被限制在沿着支气管移动，我们的装置将能够在肺中的任何地方转向。此外，使用从支气管镜展开的多腔可控针将降低出血（因为可以通过图像引导转向避免实质中的重要血管）和气胸（因为与经胸穿刺活检相比，我们的器械从不穿刺肺部周围的胸膜）的严重风险。具体目标是（1）开发用于肺部手术的支气管镜展开多腔可控针，（2）使用器械硬件和图像引导计划软件构建原型系统，以及（3）通过在充气的离体猪肺中进行CT引导实验评估系统的有效性。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。我们将在查佩尔山的北卡罗来纳州大学进行评估实验，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。拟议中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。这项拟议中的研究有可能通过实现低风险，可靠地获取肺部任何地方的结节，以进行早期，明确的肺部诊断，从而增强公共卫生。癌一旦多腔可操纵针安全到达结节，新设备还将能够通过化疗灌注，消融和近距离放射治疗提供局部治疗。