DESIGN OF A STEROTAXIC BREAST BIOPSY COIL FOR MRI

MRI 立体定向乳腺活检线圈的设计

• 批准号: 2104158
• 负责人: SUSAN A STRENK
• 金额: $ 19.66万
• 依托单位: DIAGNOSTIC INSTRUMENTS, INC.
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-07 至 1997-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2104158
• 关键词: biomedical equipment development; biopsy; breast neoplasm /cancer diagnosis; computer program /software; computer system design /evaluation; human subject; magnetic resonance imaging; phantom model

Magnetic resonance imaging (MRI) has detected breast lesions that had previously been sub-clinical. However, MRI's 40% false positive detection rate necessitates biopsy of these lesions to confirm diagnosis. No commercially available device exists which allows this procedure to be performed without open biopsy. Several designs for a stereotaxic MRI breast biopsy device have been offered in recent literature however, none provide the l mm needle positioning accuracy required for clinical effectiveness. Our Phase l efforts produced a radio frequency (rf) receiver coil for breast MR imaging with excellent signal-to-noise ratio characteristics and integrated stereotaxic capabilities resulting in submillimeter needle positioning accuracy in phantom studies. This device is a modification of breast coil T803 which has received FDA approval to market and was designed by PI, a Ph.D. biomedical engineer. Phase II support is requested to expand the capabilities of the device to allow biopsy of lesions near the chest wall, to automate the calculation of needle position coordinates and to address clinical issues including breast compression so that l mm needle positioning accuracy can be obtained clinically. Two thousand MR imagers in the U.S. alone indicate commercial application potential for this device. PROPOSED COMMERCIAL APPLICATION: The successful development of a stereotaxic breast biopsy coil will allow physicians to detect and biopsy suspected cancerous lesions with significantly greater sensitivity than current methods allow. Estimated market potential for this device is over $60 million based on 2000 MR imagers in the United States.

磁共振成像（MRI）检测到乳腺病变， 以前是亚临床的。然而，核磁共振成像40%的假阳性检测 因此，需要对这些病变进行活检以确诊。没有 市场上有一种装置，它可以使这一过程 不进行开放性活检。 立体定位MRI的几种设计 在最近的文献中已经提供了乳房活检装置，但是，没有 提供临床所需的l mm针定位精度 有效性 我们的第一阶段工作产生了一个无线电频率（rf） 具有优良信噪比的用于乳房MR成像的接收器线圈 特征和综合立体定位能力， 体模研究中的亚毫米针定位精度。 这个设备 是乳房线圈T803的改进，已获得FDA批准， 市场，并由PI设计，博士。生物医学工程师 二期 要求提供支持，以扩展设备的功能， 胸壁附近病变的活检，以自动计算 针位置坐标，并解决临床问题，包括 乳房压缩，使l毫米针定位精度可以 临床上获得的。 仅在美国就有2000台磁共振成像仪 该装置的商业应用潜力。 建议的商业应用：成功开发一种 立体定位乳腺活检线圈将允许医生检测和活检 疑似癌性病变的敏感性显著高于 目前的方法允许。估计该设备的市场潜力已经超过 6000万美元，基于美国2000台MR成像仪。