Laser endoscopy for guided biopsy in the bile duct

描述(由申请人提供)：本申请涉及广泛的挑战领域(06)使能技术和具体的挑战主题，06-DK-103：使能成像技术。胆管良性狭窄和恶性狭窄的鉴别是很困难的。虽然非侵入性成像手段可以定位狭窄，但没有细胞和组织的光学测量就不能做出明确的诊断，因为没有生物标记物存在。经口腔胆道镜是对胆管进行光学成像的最小侵入性方法，但要达到狭窄，需要长的、灵活的和小直径的内窥镜。目前的技术是为采集图像中的每个像素配备成像传感器或光纤，不允许同时进行超薄和高分辨率内窥镜检查，这使得临床医生在为胆管成像时合法地失明。提出了一种新技术，将一个小型微型扫描仪放在导管的顶端，制作一个只有9 mm的刚性尖端和一个弯曲半径为6 mm的坚固软轴。以前，这种带远端微扫描仪的导管镜可以在30赫兹(视频率)下获得600线彩色图像，并在活体猪身上进行了胆管成像。在这项建议中，将在HDTV(1024行)上增加尖端弯曲和加倍的光学分辨率，以开发一种新的可操纵的“带眼导丝”。拟议的新带眼导轨的直径将为1.2至1.6毫米，大约是标准导轨直径的两倍。新的插管式刷子和钳子工具将被开发用于图像引导活检，并首先在猪胆管中进行测试，然后在至少20名人类受试者中进行测试，分为良性和恶性狭窄原因。由于1毫米导管镜可能能够穿过狭窄，任何可疑的癌的分期或侧向范围都将被测量。这种扫描导管镜的其他临床优势是低功率、红、绿、蓝激光固有的窄带，增强的光谱成像和变焦放大都是用户控制的实时功能。通过增强图像对比度和特征大小，可以改进活检部位的选择，临床医生在内窥镜逆行胆管造影术过程中不再需要在法律上失明。未来，当胆道监测变得更加普遍时，激光照明可以改变，以测量早期癌症和癌前病变的荧光生物标志物信号，而不会增加探头的尺寸、成本或复杂性。 公共卫生相关性：确定胆管疾病的诊断和程度是极其困难的，而且在目前的内窥镜技术下，这些决定是在临床医生合法盲目的情况下做出的。因此，提出了一种新的激光扫描技术，用于图像引导胆管疾病的诊断，提供高质量的视频图像。这项新技术将被开发和测试，目的是提高诊断胆道疾病的效率和准确性，特别是可以模仿这种致命疾病的良性并发症导致的癌症。该项目的目标是提供更高的准确性和诊断产量的活检，同时引入一种侵入性较小的临床仪器。拥有一种更有效、侵入性更小的临床工具有望降低治疗不明胆管狭窄患者的总体成本。

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (06) Enabling Technologies and specific Challenge Topic, 06-DK-103: Enabling Technologies in Imaging. Determination between benign and malignant strictures in the bile ducts is difficult. Although non-invasive imaging modalities can locate the stricture, a definitive diagnosis cannot be made without an optical measurement of cells and tissue as no biomarker exists. Peroral cholangioscopy is the least invasive method to optically image the bile ducts but to reach a stricture requires a long, flexible, and small-diameter endoscope. The current technology of an imaging sensor or optical fiber for each pixel in the acquired image does not allow both ultrathin and high-resolution endoscopy, making the clinician legally blind when imaging the bile duct. A new technology is proposed that puts a small microscanner at the tip of a catheter, making a rigid tip of only 9-mm and a rugged flexible shaft with a 6-mm bending radius. Previously this catheterscope with distal-tip microscanner can acquire 600-line color images at 30 Hz (video rate) and bile duct imaging has been performed in a live pig. In this proposal, the addition of tip bending and a doubling of the optical resolution to HDTV (1024 lines) will be developed for a new steerable "guidewire with eyes". The proposed new guidewire with eyes will be 1.2 to 1.6 mm in diameter, approximately twice the diameter of a standard guidewire. New cannula-style brush and forceps tools will be developed for image-guided biopsy and tested first in pig bile ducts and then in at least 20 human subjects, split between having benign and malignant causes of the stricture. Since the 1-mm catheterscope may be able to traverse the stricture, staging or lateral extent of any suspected carcinoma will be measured. Additional clinical advantages of this scanning catheterscope are that the low-power, red, green, and blue laser light is inherently narrow band and both enhanced spectral imaging and zoom magnification are user-controlled real-time features. By enhancing image contrast and feature size, biopsy site selection can be improved and no longer does the clinician have to be legally blind during an endoscopic retrograde cholangiography procedure. In the future, when bile duct surveillance is more common, the laser illumination can be changed to measure fluorescence biomarker signatures of early cancer and pre-cancer without adding size, cost, or complexity to the probe. PUBLIC HEALTH RELEVANCE: Determining diagnosis and extent of disease in the bile duct is extremely difficult, and with current endoscope technology these decisions are being made with clinicians legally blind. Therefore, a new laser scanning technology for image-guided diagnosis of disease in the bile duct is proposed that affords high quality video imaging. This new technology will be developed and tested for the purpose of improving the efficiency and accuracy of diagnosing bile duct diseases, especially cancer from benign complications that can mimic this deadly disease. The goal of this project is to provide biopsies with higher accuracy and diagnostic yields, while introducing a less invasive clinical instrument. Having a more effective and less invasive clinical instrument is expected to lower overall cost for managing patients with indeterminate biliary strictures.