A Minimally Invasive Device for Endometrial Imaging

描述（由申请人提供）：子宫异常出血（AUB）是女性去看妇科医生最常见的原因之一，每年有300万次就诊。我们建议开发一种微创子宫内膜成像探针（EIP），以促进对这些患者的评估。该设备将能够创建子宫内膜的高分辨率视觉地图。该过程将包括一个简单的基于办公室的程序，大约需要一分钟，而不是宫腔镜所要求的子宫扩张。在第一阶段，我们开发了一个外径为3.25mm的原型探头，一个新颖的全方位尖端和一个伺服马达。专门的去翘曲和拼贴软件将数百个图像帧组合成子宫内膜腔轴向段（从眼底到子宫颈）的单一高分辨率地图。我们成功地通过体外人子宫成像获得了概念验证。我们现在建议发展先进的二维视觉运动跟踪。这将使探针能够自由移动，并允许它以类似于子宫声音或子宫内膜活检管道的方式进行操作。最重要的是，它将使从眼底主轴到宫颈的子宫内膜成像成为可能。因此，将对角膜进行成像，并生成整个子宫内膜腔的视觉图。该系统随后将在试点临床研究中进行测试。使用半定量子宫内膜腔评估系统（SECES），我们将确定子宫切除术时相对于子宫内膜腔的大体和组织病理学评估的EIP图像的准确性。我们的长期目标是生产一种简单的设备来调查办公室环境中异常出血的患者。

DESCRIPTION (provided by applicant): Abnormal uterine bleeding (AUB) is one of the most common reasons for a woman to visit her gynecologist, resulting in 3 million visits per year. We propose the development of a minimally invasive Endometrial Imaging Probe (EIP) to facilitate the evaluation of these patients. This device would enable creation of high- resolution visual maps of the endometrium. The procedure would involve a simple office-based procedure requiring about one minute, and not involve distention of the uterus as is required by hysteroscopy. During Phase I we developed a prototype probe with an outer diameter of 3.25mm, a novel omni-directional tip, and a servomotor. Specialized dewarping and collaging software combines several hundred image frames into a single high-resolution map of an axial segment of the endometrial cavity (from the fundus to the cervix). We successfully obtained proof-of-concept by imaging ex vivo human uteri. We now propose the development of advanced two-dimensional visual motion tracking. This will enable free-hand motion of the probe and allow it to be manipulated in a fashion similar to a uterine sound or an endometrial biopsy Pipelle. Most importantly, it will enable imaging of endometrium away from the primary axis of the fundus to the cervix. Thus, the cornua will be imaged and a visual map of the entire endometrial cavity will be produced. The system will then be tested in a pilot clinical study. Using a Semi-quantitative endometrial cavity evaluation system (SECES), we will determine the accuracy of EIP image relative to gross and histopathological evaluation of the endometrial cavity at the time of hysterectomy. It is our long term goal to produce a simple device to investigate patients with abnormal bleeding in the office setting.