A Minimally Invasive Device for Endometrial Imaging

描述（由申请人提供）：异常子宫出血（AUB）是女性去看妇科医生的最常见原因之一，每年有300万人次就诊。我们建议开发一种微创子宫内膜成像探头（EIP），以方便这些患者的评估。该设备将能够创建子宫内膜的高分辨率视觉图。该程序将涉及一个简单的基于办公室的程序，需要大约一分钟，而不是像宫腔镜检查所要求的那样涉及子宫扩张。在第一阶段，我们开发了外径为3.25 mm的原型探针，一种新型的全向尖端和一个可拆卸的探针。专业的去扭曲和拼贴软件将数百帧图像组合成子宫内膜腔（从眼底到宫颈）轴向段的单个高分辨率图。我们成功地获得了概念验证的离体人类子宫成像。我们现在提出了先进的二维视觉运动跟踪的发展。这将使探针能够自由移动，并允许以类似于子宫探测器或子宫内膜活检Pipelle的方式对其进行操纵。最重要的是，它将使子宫内膜的成像远离基底的主轴到子宫颈。因此，角将被成像，并产生整个子宫内膜腔的视觉图。该系统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EIP图像相对于子宫切除术时子宫内膜腔的大体和组织病理学评估的准确性。我们的长期目标是生产一种简单的设备，用于研究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.