Image-guided catheter biopsy of peripheral lung cancer

描述(由申请人提供) 经支气管针吸细胞学刷检是肺癌早期诊断的首选方法。然而，由于活检过程中组织不能清晰地成像，在较外围的肺内采样病变的诊断良率(敏感性)较低。主要问题是缺乏一种超薄和灵活的支气管镜，在提供活检通道的同时保持高分辨率成像。一种新的微制造技术已经被开发出来，它将一根商业光纤微加工成谐振悬臂梁，从而产生大视场的定向激光照射，以实现低成本的活体成像。光纤扫描仪可以安装在直径为2 mm的范围内，从而可以构造出类似导管的柔性范围。这种类似导管的显微镜可以用于成像人体的区域，这些区域已经被更大、更不灵活和更昂贵的显微镜基于没有活检通道空间的相干光纤束而无法接触到。 宾得公司有权从华盛顿大学获得这项纤维扫描导管镜技术的许可，双方已经建立了联合伙伴关系，将这项技术开发成设备的原型，并开发出制造工艺的原型，这将导致具有一次性远端的活体成像仪器。这个项目的目标是(I)建造一个直径2.0 mm的导管镜原型，其活组织检查通道可以通过22号针头；(2)使用低成本部件并开发大批量制造工艺，从而使远端的总成本为100英镑；(3)使用体外模型和适当的动物模型测试图像引导活检的原型；以及(4)促进从学术发明者到医疗器械制造商的技术转让，以便在降低医疗成本的同时显著提高对周围肺癌症的成功诊断。在未来的临床实践中，导管镜将通过更大的支气管镜的活检通道引入周围肺，并可能在没有透视的情况下使用，进一步降低肺癌诊断的成本。由于直接激光照明，光纤扫描导管可以与基于激光的诊断和治疗结合使用，例如405 nm激光诱导的本征荧光，以改进活检点的选择，未来的应用是胰腺癌、乳腺癌、膀胱癌和其他管腔癌的诊断。

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.