Image-guided catheter biopsy of peripheral lung cancer

描述（由申请人提供） 经支气管针吸活检和刷检细胞学是肺癌早期诊断的首选方法。然而，在更外围的肺中采样病变具有低诊断率（灵敏度）的概率，因为组织在活检程序期间不能被清楚地成像。主要的问题是缺乏一个灵活的支气管镜，保持高分辨率成像，同时提供活检通道。已经开发出一种新的微加工技术，该技术将单个商业光纤微加工成谐振悬臂，该谐振悬臂产生用于低成本体内成像的定向激光照明的宽视场。光纤扫描仪可以安装在2 mm直径内，以便可以构造类似于导管的柔性范围。这种导管状内窥镜可用于对人体的区域进行成像，这些区域对于基于相干光纤束的更大、更不灵活和更昂贵的内窥镜是不可接近的，这些光纤束没有用于活检通道的空间。 宾得公司可以选择从华盛顿大学获得该光纤扫描导管技术的许可，并且已经形成了一个联合伙伴关系，以将该技术开发为器械的原型以及原型制造过程，这将导致具有一次性远端的体内成像仪器。该项目的目标是（I）构建一个直径为2.0 mm的原型导管镜，其活检通道可以通过22号针，（2）使用低成本组件并开发大批量制造工艺，因此远端的总成本<100美元，（3）使用体外模型和适当的动物模型测试原型的图像引导活检，以及（4）促进从学术发明者到医疗设备制造商的技术转移，使得可以显著提高外周肺中癌症的成功诊断，同时降低医疗保健成本。在未来的临床实践中，将通过更大的支气管镜的活检通道将导管镜引入周围肺，并可能在不借助透视的情况下使用，进一步降低肺癌诊断的成本。由于定向激光照明，光纤扫描导管镜可以与基于激光的诊断和治疗结合使用，例如在405 nm处的激光诱导固有荧光，用于改进活检部位的选择，未来的应用是胰腺癌、乳腺癌、膀胱癌和其他内腔癌的诊断。

DESCRIPTION (provided by applicant) Transbronchial needle aspiration and cytological brush sampling of the bronchi are the methods of choice for early diagnosis of lung cancer. However, sampling lesions in the more peripheral lung have low probability of diagnostic yield (sensitivity) because the tissue cannot be clearly imaged during the biopsy procedure. The major problem is the lack of an ultrathin and flexible bronchoscope that maintains high-resolution imaging while providing a biopsy channel. A new microfabrication technique has been developed that micromachines a single, commercial optical fiber into a resonant cantilever that produces wide a field-of-view of directed laser illumination for low-cost in vivo imaging. The fiberoptic scanner can be fit within a 2 mm diameter, so that a flexible scope resembling a catheter can be constructed. This catheter-like scope can be used for imaging regions of the human body that have been inaccessible to larger, less flexible, and more expensive scopes based on coherent fiberoptic bundles that do not have room for a biopsy channel. The Pentax Corporation has an option to license this fiber-scanning catheterscope technology from the University of Washington, and a joint partnership has been formed to develop this technology to a prototype the device and also to prototype manufacturing processes that will lead to an in vivo imaging instrument with a disposable distal end. The goals of this project are to (I) construct a 2.0 mm diameter prototype catheterscope with a biopsy channel that can pass a 22-gauge needle, (2) use low-cost components and develop high-volume manufacturing processes so the total cost of the distal end is <$100, (3) test the prototype for image-guided biopsy using an in vitro model and an appropriate animal model, and (4) facilitate technology transfer from the academic inventors to the medical device manufacturer so that the successful diagnosis of cancer in the peripheral lung can be significantly improved while healthcare costs are reduced. In future clinical practice, the catheterscope will be introduced into the peripheral lung through the biopsy channel of a larger bronchoscope, and possibly used without the aid of fluoroscopy, further reducing the cost of lung cancer diagnosis. Due to the directed laser illumination, the fiber-scanning catheterscope can be used in conjunction with laser-based diagnoses and therapies, such as laser-induced intrinsic fluorescence at 405 nm for improved selection of biopsy sites, Applications in the future are the diagnosis of pancreatic, breast, bladder, and other lumenal cancers.