Measuring Endoscopic Probe - A Novel Supportive Tool for Endoscopy

描述(申请人提供)：在许多工业领域中，难以接近区域的非接触式远程尺寸测量是无损远程视觉评估的重要组成部分。内窥镜是用于这一目的的主要设备。然而，不可能使用不配备附加特征的内窥镜测量成像物体的实际尺寸，因为仪器根据其与内窥镜尖端的距离放大物体细节，而该距离是未知的，并且在检查期间不断变化。这种测量情况在1996年发生了变化，奥林巴斯工业公司推出了一种双目标测量内窥镜，该内窥镜产生了一种光学立体视，可以通过经典的双相机摄影测量中使用的三角测量法来确定距离。该内窥镜的外轴直径为4.4 mm，该装置在工业领域应用广泛。然而，医学界没有接受这种设备，很可能是因为两个原因：(I)与内窥镜视觉检查中使用的更大视角(超过1100)相比，视角(700)更小；(Ii)测量过程中涉及的高成本。诊断性内窥镜检查通常是定性的。医生通过观察组织颜色和异常情况得出结论。正在使用的是具有大视场的高质量彩色再现设备。然而，随着医学诊断的进步，在内窥镜检查过程中对定量测量的要求越来越高。开发一种具有测量能力的内窥镜支持工具，不仅不会中断内窥镜检查过程，而且可以快速为诊断提供定量支持，这对医生来说是有价值的。该工具最好通过内窥镜的器械通道输送，其他支持工具也是如此。然而，仪器通道的直径是有限制的，两个透镜的探头，如奥林巴斯探头，不能安装在通道中。智能光学系统公司(IOS)正在与加州大学洛杉矶分校医学中心和工程学院合作，开发专门致力于制造新型独特手术工具和MEMS设备的技术，以增强内窥镜测量能力。IOS已经开发并证明了一种方法，使用单个透镜，在透镜前面有光学透明的倾斜板来生产立体视觉。加州大学洛杉矶分校的研究人员制造并演示了一种结合了光学透明板的MEMS设备的可操作性。在这个项目中，iOS-UCLA团队提议开发一种直径不超过2.5 mm的单透镜内窥镜测量探头。在第一阶段，该团队将在已经制造的倾斜板的基础上制造和演示直径5.5 mm的测量内窥镜探头原型；开发测量算法和软件，并修改MEMS制造流程以将设备尺寸缩小到2.5 mm。测量内窥镜探头的商用前原型将在第二阶段结束时提交，供FDA批准。 公共卫生相关性：在内窥镜诊断过程中，量化病变、息肉和其他组织病理部分的大小的要求正在增长。然而，不存在可靠、低成本、高精度的工具来支持具有定量数据的内窥镜检查程序。内部监督办公室与加州大学洛杉矶分校的研究人员合作，提议开发一种测量内窥镜探头，这是一种可以插入内窥镜仪器通道的工具，将在内窥镜检查过程中提供生物物体的尺寸测量。这一新的工具将有助于减少内窥镜诊断中仍然存在的不确定性数量。

DESCRIPTION (provided by applicant): Noncontact remote dimensional measurements in difficult to access areas are an important part of nondestructive remote visual evaluation in many industrial fields. Endoscopes are the major devices that are used for this purpose. It is impossible, however, to measure the actual size of the imaged objects using an endoscope that is not equipped with additional features, as the instrument magnifies object details depending on its distance from the endoscope tip, and this distance is unknown, and is constantly changing during the examination. This measurement situation changed, in 1996, when Olympus Industrial introduced a two objective measuring endoscope that produced an optical stereopair that could be used to determine distance via the triangulation method used in classical two-camera photogrammetry. The diameter of the outer shaft of this endoscope is 4.4mm, and the device is widely used in the industrial field. The medical community, however, has not embraced this device, most likely for two reasons: (i) a reduced angle of view (700) compared to the larger angle of view (more than1100) used in endoscopic visual examination; and (ii) the high cost involved in the measurement process. Diagnostic endoscopy is typically qualitative. The physicians make conclusions from observation of the tissue colors and abnormalities. High quality color reproduction devices with a wide field of view are in use. As medical diagnostics progresses, however, there are more requests for quantative measurements during endoscopy. The development of an endoscopic supportive tool with measurement capabilities, that will not interrupt the endoscopic procedure, but can rapidly provide quantative support to the diagnosis, would be valuable to medical practitioners. This tool would best be delivered through the instrumental channel of the endoscope, as are other supportive tools. The diameter of the instrumental channel is restricted, however, and a two lens probe, such as the Olympus probe, will not fit in the channel. Intelligent Optical Systems (IOS) is collaborating with the UCLA Medical Center and School of Engineering to develop technologies specifically focused on the fabrication of novel unique surgical tools and MEMS devices to enhance endoscope measurement capabilities. IOS has developed and proven a method of producing a stereopair using a single lens with an optically transparent tilting plate in front of the lens. UCLA researchers have fabricated and demonstrated the operability of a MEMS device incorporating an optically transparent plate. In this project, the IOS-UCLA team proposes to develop a single lens endoscopic measuring probe no more than 2.5mm in diameter. In Phase I, the team will fabricate and demonstrate a measuring endoscope probe prototype 5.5mm in diameter, based on an already fabricated tilting plate; develop measurement algorithms and software, and modify the MEMS fabrication flow process to downsize the device to the 2.5mm dimension. A precommercial prototype of the measuring endoscopic probe, ready for FDA approval, will be presented at the end of Phase II. PUBLIC HEALTH RELEVANCE: Requirements for quantifying the size of lesions, polyps, and other pathological parts of tissue during endoscopy diagnostics, are growing. Reliable, low cost, high accuracy tools to support endoscopy procedures with quantative data, however, do not exist. IOS, in collaboration with UCLA researchers, proposes to develop a measuring endoscopic probe, a tool that can be inserted into the instrumental channel of the endoscope, and will provide dimensional measurements of biological objects during endoscopic procedures. This novel tool will help to reduce the number of uncertainties that still exist in endoscopy diagnosis.