Bronchoscopic Steerable Needles for Transparenchymal Access to Lung Nodules

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Project Summary/Abstract The objective of this proposal is to create a new robotic system that deploys bronchoscopic steerable needles that can steer through the lung parenchyma to safely biopsy nodules that are currently inaccessible bronchoscop- ically. The need for better lung biopsy approaches is motivated by the fact that lung cancer kills over 150,000 Americans each year and that survival depends on early diagnosis, which requires biopsy to be definitive. Cur- rent approaches for accessing suspicious nodules for biopsy either are unable to accurately reach many nodules in the peripheral lung (i.e., those not adjacent to a bronchial tube) or risk pneumothorax (lung collapse), which is a particularly significant risk for patients with chronic obstructive pulmonary disease. To broaden the class of patients for which early-stage definitive diagnosis is accurate and safe, the new system we propose will harness the capabilities of a new class of steerable needles to extend the range of bronchoscopes and reliably and safely biopsy nodules throughout the lung. Compared to percutaneous biopsy, the new system will decrease the risk of pneumothorax since the needles are deployed from within the lung, without puncturing the pleura. Our new system will be clinically innovative since it will provide transbronchial access to nodules throughout the lung, increase targeting accuracy through steering and semi-automatic control, and be able to avoid major bleeding by steering the needle around blood vessels. It will be technically innovative since its novel 3-stage design facilitates deployment of a flexure-tip steerable needle through a bronchoscope into the lung parenchyma, will integrate biopsy collection with a steerable needle for the first time ever, and will utilize human-robot collabo- ration to optimize needle steering and ensure patient safety. Our approach is to use a three-stage robotic device. The physician will first guide a bronchoscope through the airways to a desired exit point, then deploy a concentric tube needle through the bronchoscope's port and out through the bronchial wall. This concentric tube needle will aim at the desired nodule and be the launch point for a flexure-tip steerable needle that will travel through the lung parenchyma under image guidance with feedback from electromagnetic tracking. To create this system, our specific aims are to (1) design and build a robotically-controlled steerable needle deployed via a bronchoscope, (2) develop an intuitive physician interface with semi-automatic needle steering, and (3) conduct preclinical system validation studies using lung phantoms, ex vivo porcine lungs, and live animal studies. This project brings together a multidisciplinary team that spans the areas of expertise necessary to accomplish these aims, including expertise in interventional pulmonology, cardiothoracic surgery, radiology, medical image analysis, mechanical engineering, and computer science. This proposed research has the potential to enhance public health by enabling low-risk, reliable access to nodules throughout the lung for early-stage, definitive diagnosis of lung cancer.