Electromagnetic Tracking for MRI-guided Interventions

描述(由申请人提供)：研究的长期目标 是开发一种与核磁共振扫描仪一起使用的最佳跟踪技术。这个 具体目标是完成跟踪系统的开发；测试 它在影像引导、微创诊断和治疗中的应用 神经外科、乳腺活检和前列腺的临床应用 近距离放射治疗；并完成获得监管所需的所有任务 市场营销许可。目前用于磁共振成像的跟踪技术有许多 限制和改进的技术可以扩大MRI引导的使用 对多个临床领域进行干预，降低医疗成本，改善 病人的转归。在第二阶段项目期间，我们计划完成 商业跟踪系统的原型，以开发一种新型的低成本， 一次性传感器，将此原型安装在领先的临床中心 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。技术开发和技术开发完成 临床申请的演示将使上市前的备案成为可能 通知FDA和跟踪系统的初步营销。vbl.使用 发展跟踪传感器的先进微电子制造方法 有潜力为新的体内提供创新的微型传感器 跟踪应用程序。 建议的商业应用： 1.磁共振扫描仪的跟踪系统(硬件和软件的初始安装、服务、 升级)。2.一次性跟踪传感器：用于跟踪头部位置和 诊断性和介入性脑核磁共振扫描的运动；连接到 或集成到一次性设备中-活组织检查和抽吸针头、导管；传感器 集成到多用途设备中--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.