Electromagnetic Tracking for MRI-guided Interventions

描述（申请人提供）：研究的长期目标 是开发一种最佳的跟踪技术，用于MRI扫描仪。的 具体目标是完成跟踪系统的开发;测试 其用于图像引导、微创诊断和治疗 神经外科、乳腺活检和前列腺的临床应用 近距离放射治疗;并完成所有必要的任务，以获得监管 销售许可。目前用于MRI的跟踪技术具有许多优点。 限制和改进的技术可以扩大MRI引导的使用 许多临床领域的干预措施，降低医疗保健成本，并提高 患者的结果。在第二阶段，我们计划完成 商业跟踪系统的原型，开发一种新型的低成本， 一次性传感器，在领先的临床中心安装这个原型， MRI引导的干预，以测试其准确性和可靠性，并使用它 有三种临床应用-神经外科、乳腺活检和前列腺 近距离放射治疗技术开发的完成和 临床应用的证明将使上市前申请 通知FDA和跟踪系统的首次上市。使用 先进的微电子制造方法来开发跟踪传感器 有可能为新的体内植入提供创新的微传感器， 跟踪应用程序。 拟定商业应用： 1. MRI扫描仪跟踪系统（硬件和软件的初始安装、服务， 升级）。 2.一次性跟踪传感器：小的粘性垫，用于跟踪头部位置， 用于诊断和介入性脑部MRI扫描的运动;连接到 或集成到一次性使用设备中-活检和抽吸针、导管;传感器 集成到多用途器械中-微创手术工具、内窥镜。

DESCRIPTION (Provided by Applicant): The long-term objectives of the research are to develop an optimal tracking technology for use with MRI scanners. The specific aims are to complete the development of the tracking system; to test its use with image-guided, minimally-invasive diagnostic and therapeutic clinical applications for neurosurgery, breast biopsy, and prostate brachytherapy; and to complete all tasks necessary to obtain regulatory clearance for marketing. Current tracking technologies for MRI have many limitations and improved technology can expand the use of MRI-guided interventions to many clinical fields, reduce healthcare costs, and improve the outcome of patients. During the Phase II project we plan to complete the prototype of the commercial tracking system, to develop a new type of low-cost, disposable sensors, to install this prototype in a leading clinical center for MRI-guided interventions, to test its accuracy and reliability, and to use it with three clinical applications - neurosurgery, breast-biopsy, and prostate brachytherapy. The completion of the technical development and the demonstration of clinical applications will enable the filing of premarket notification to the FDA and initial marketing of the tracking system. Using advanced microelectronic fabrication methods to develop the tracking sensors has the potential to provide innovative micro-sensors for new intrabody tracking applications. PROPOSED COMMERCIAL APPLICATION: 1. Tracking systems for MRI scanners (initial installation of hardware and software, service, upgrades). 2. Disposable tracking sensors: small adhesive pads to track head position and motion for diagnostic and interventional brain MRI scanning; disposable sensors attached to or integrated into single-use-devices-biopsy and aspiration needles, catheters; sensors integrated into multiple-use devices - minimal invasive surgery tools, endoscopes.