A Minimally Invasive Device for Endometrial Imaging

描述（由申请人提供）：子宫内膜癌是美国最常见的妇科癌症，在其一生中影响超过1/50的妇女。在诊断子宫内膜病理方面，宫腔镜引导下活检明显比盲法子宫内膜活检（EMB）更敏感。然而，大多数妇科医生不使用宫腔镜，主要是由于陡峭的学习曲线。因此，我们建议开发一种自动化微创成像设备，它与EMB一样易于使用。 该器械使用3 mm刚性杆式光学内窥镜。它是由一个自动控制，以产生一个单一的二维图像的整个子宫内膜腔，包括可视化病变。随后，可以使用子宫内膜定位系统和来自子宫内膜图的病变坐标来完成定向活检。 第一阶段的原型将包括一个360度全景成像内窥镜，特殊的图像处理软件，和全色CCD技术，以产生一个单一的集成子宫内膜地图。我们将在离体人类子宫中测试该系统，并表征其相对于解剖子宫的目视检查的性能。如果我们获得成像系统的概念验证，我们希望进入第二阶段，该阶段将专注于活检设备的集成，并在动物模型和临床研究中测试该设备。我们的长期目标是将该设备用作准确识别和子宫内膜病理活检的微创工具。 建议的商业应用：仅今年就将有38，300例女性子宫内膜癌新发病例。 如果该设备被证明可以创建一种简单的方法来成像子宫内膜和直接活检，它将对妇科临床实践产生重大影响。

DESCRIPTION (provided by applicant):Endometrial carcinoma is the most common gynecological cancer in the United States, affecting over 1 in 50 women during her lifetime. Image-guided biopsy using the hysteroscope is significantly more sensitive than blind endometrial biopsy (EMB) for diagnosis of endometrial pathology. However, the majority of gynecologists do not use hysteroscopy, largely due to a steep learning curve. Therefore, we propose development of an automated minimally invasive imaging device which is as easy to use as an EMB. The device uses a 3mm rigid rod-optic endoscope. It is automatically controlled by a servomotor to produce a single two-dimensional image of the entire endometrial cavity, including visualization of lesions. Subsequently, a directed biopsy may be accomplished using the servomotor system and the coordinates of the lesion from the Endometrial Map. The Phase I prototype will incorporate a 360-degree panoramic imaging endoscope, special image-processing software, and full color CCD technology to produce a single integrated Endometrial Map. We will test this system in ex-vivo human uteri and characterize its performance relative to visual inspection of the dissected uterus. If we obtain proof-of-concept of the imaging system, we hope to proceed to Phase II, which will focus on integration of the biopsy apparatus, and testing the device in an animal model and in a clinical study. It is our long-term goal that the device will be used as a minimally invasive tool for accurate identification and directed biopsy of endometrial pathology. PROPOSED COMMERCIAL APPLICATION: This year alone there will be 38,300 new cases of endometrial cancer in women. If the device proves to create a simple method to image the endometrium and direct biopsies, it will have a major impact on the clinical practice of gynecology.