Department of Radiology, University of Michigan Health System, 1500 East Medical Drive, Ann Arbor, MI 48109-0030, USA.
Acad Radiol. 2010 Feb;17(2):142-5. doi: 10.1016/j.acra.2009.09.005. Epub 2009 Nov 11.
Current wire localization compression paddles provide a limited access window with no compression in this window. We describe a new compression paddle that addresses these issues and report on preliminary patient testing.
Four mechanical engineering students collaborated with a medical physicist, a radiographer, and two radiologists. Several concept designs were developed, one of which used a mesh surface. This went on to prototype development. After phantom testing, internal review board approval, US Food and Drug Administration waiver for nonsignificant risk device, and Medicare Part A exemption were obtained, the device was used in 10 patients going to wire localization for medical indications. Informed consent was obtained and a range of breast size was included. Wires were positioned from superior, lateral, and medial approach.
A total of 10 wires were successfully positioned in nine patients. The one technical failure was due to inadequate access to the axillary region because of the single prototype size. The grid system provided accurate localization of suspicious findings. The mesh was not visible in digital mammograms so there was no interference.
The new paddle improves on currently available models. Advantages included lack of visual (on imaging) and technical interference from the compression mesh, and compression of the active window allowed localization of subtle findings. The large active area facilitated multiple wire placements within a single window. All localizations were easily performed on the initial image because of the large active window, obviating the need for acquisition of additional images and the associated additional radiation.
目前的导丝定位压缩板在这个窗口中提供了有限的进入窗口，且没有压缩。我们描述了一种新的压缩板，解决了这些问题，并报告了初步的患者测试结果。
四名机械工程专业的学生与一名医学物理学家、一名放射技师和两名放射科医生合作。开发了几个概念设计，其中一个使用了网格表面。这进一步发展为原型开发。在进行了体模测试、内部审查委员会批准、美国食品和药物管理局对非显著风险设备的豁免以及医疗保险 A 部分豁免之后，该设备在 10 名因医疗指征而进行导丝定位的患者中使用。获得了知情同意，并纳入了一系列不同乳房大小的患者。导丝从上方、外侧和内侧进入进行定位。
总共在 9 名患者中的 10 根导丝成功定位。只有一次技术失败是由于单个原型尺寸导致腋部进入不足。网格系统提供了可疑发现的准确定位。网格在数字乳腺 X 线照片中不可见，因此没有干扰。
新的压缩板改进了现有的模型。优点包括缺乏视觉（在成像上）和压缩网格的技术干扰，以及主动窗口的压缩允许对细微发现进行定位。较大的活动区域便于在单个窗口内放置多个导丝。由于较大的活动窗口，所有的定位都可以在初始图像上轻松进行，无需获取额外的图像和相关的额外辐射。
