Robotic Haptic Feedback System for Bx/RFA of Breast Tumor under Continuous MRI

描述(申请人提供)：美国癌症协会估计，2008年，仅在美国就有182,460名妇女被诊断出患有乳腺癌，40,480名妇女将死于乳腺癌。今天出生的女性中，每8个人中就有一个可能在有生之年被诊断出患有乳腺癌。尽管这些统计数字令人沮丧，但由于过去十年在诊断和治疗方面的创新，积极的趋势是显而易见的。最近，医学杂志《柳叶刀》和《新英格兰医学杂志》上报道的大规模研究表明，MRI作为诊断乳腺癌的有效工具的价值。因此，将诊断与基于MRI的活检(Bx)相结合将有助于更好地描绘肿瘤边缘。对于乳腺癌的治疗，射频消融(RFA)已经成为早期乳腺癌的一种有前途的方法，在不需要完全手术干预的情况下，最大限度地有效地保护了健康的乳腺组织。虽然超声(US)和计算机断层扫描(CT)是RFA的成像手段，但它们也不是没有缺点。在美国，针头放置的精确度是有限制的，在RFA过程中形成的微泡导致的图像失真模糊了肿瘤的可视化。CT缺乏提供像MRI那样好的软组织对比的能力，而且还使患者暴露在辐射剂量下。另一方面，MRI提供良好的软组织对比度，无电离辐射，并在消融部位提供准确的热像图。尽管射频消融术在治疗多种类型的病变中已被证明是有效的，但肿瘤的复发率并不像人们所希望的那样低(8-47%)。使用US、CT或MRI进行乳腺活检时，肿瘤在RFA后复发或被误诊，可能是基于早期获得的图像而不是在连续的MRI引导下计划朝向肿瘤的轨迹的结果。尽管在置针后会进行主观评估，但即使是轨迹上的微小错误也可能导致活检和RFA的结果不太理想。因此，我们提出了一种新的机器人方法，在连续MRI下使用触觉反馈，具有正面访问(从磁孔头部)和倾斜角度针驱动的能力，用于乳腺活检和射频消融，其方式是最大限度地减少活检期间的采样误差，并在射频消融期间提供最佳治疗。建议的系统将是对目前MRI引导的有限角度针轨迹的侧(左或右)入路的重大改进。在最基本的层面上，该项目旨在为医生提供：1)在连续核磁共振下进行活组织检查和准确输送RFA探头的能力；2)具有触觉反馈能力的远程操作机器人系统，以帮助医生引导活组织检查和RFA针，其正面通道和斜角针驱动能力，使医生能够以更宽的角度接触乳房不同区域。为了实现这一目标，我们为这一极其重要的医疗保健项目组建了一支由马里兰大学医学院和美国国立卫生研究院的优秀工程师和临床医生组成的团队。 与公共健康相关：美国癌症协会估计，2008年，仅在美国，就有182,460名女性被诊断出患有乳腺癌，40,480名女性将死于乳腺癌。该项目的目的是开发一种新型的机器人系统，该系统将在连续磁共振成像下工作，用于乳腺肿瘤的活检(Bx)和射频消融(RFA)。

DESCRIPTION (provided by applicant): The American Cancer Society estimates that 182,460 women will be diagnosed with breast cancer and that 40,480 women will die of breast cancer in the United States alone in 2008. One in 8 women born today is likely to be diagnosed with breast cancer during their lifetime. Although these statistics are discouraging, positive trends are evident as a result of innovations in diagnosis and treatment over the past decade. Recent, large scale studies reported in The Lancet and The New England of Journal of Medicine demonstrate the value of MRI as an effective tool in the diagnosis of breast cancer. Hence, coupling diagnosis with MRI based biopsy (Bx) will lead to better delineation of the tumor margin. For breast cancer treatment, radiofrequency ablation (RFA) has emerged as a promising approach for early stage breast cancer with maximum effectiveness and conservation of healthy breast tissue without full surgical intervention. While Ultrasound (US) and Computed tomography (CT) is the imaging modality for RFA, they are not without their drawbacks. In US, there is limitation on the precision with which a needle placement can be performed and the image distortion due to the formation of microbubbles during RFA obscures the visualization of the tumor. CT lacks the ability of providing soft tissue contrast as good as MRI and also exposes the patients to radiation dose. MRI on the other hand provides excellent soft-tissue contrast, no ionizing radiation, and accurate thermographic maps at the ablation site. Although the utility of RFA has been demonstrated in treating several types of lesion, the recurrence rate of tumors has not been as low as one would desire (8-47%). The recurrence of cancer after RFA or misdiagnosis in a breast biopsy using US, CT, or MRI could be a result of planning the trajectory towards the tumor based on images obtained earlier and not under continuous MRI guidance. Although a subjective evaluation is performed after the placement of the needle, even small errors in the trajectory could lead to sub- optimal results for biopsy and RFA. Hence, we propose a novel robotic approach with haptic feedback under continuous MRI with frontal access (from the head of the magnet bore) and oblique angle needle driving capability for both breast biopsy and RF ablation in a manner that minimizes sampling errors during biopsy and delivers optimal therapy during RF ablation. The proposed system will be a significant improvement of the current MRI 'guided' lateral (left or right side) approach with limited angle needle trajectory. At the very fundamental level, this project seeks to provide physicians with: 1) the ability to perform biopsy and accurate delivery of RFA probe under continuous MRI and 2) a teleoperated robotic system with haptic feedback capability to help the physician guide the biopsy and RFA needle with frontal access and oblique angle needle driving capability, enabling a wider access angle to various regions of the breast. To accomplish this, we have assembled an excellent team of engineers and clinicians from the University Of Maryland School Of Medicine and the NIH for this extremely important health-care project. PUBLIC HEALTH RELEVANCE: The American Cancer Society estimates that 182,460 women will be diagnosed with breast cancer and that 40,480 women will die of breast cancer in the United States alone in 2008. The purpose of this project is to develop a novel robotic system that will work under continuous magnetic resonance imaging for both breast biopsy (Bx) and radiofrequency ablation (RFA) of breast tumor.