MRI-Compatible Fiber-Optically Sensorized Biopsy Needles for Oncological Applicat

描述（由申请人提供）：本研究的目标是开发一种创新的原型医疗器械治疗系统，该系统能够在磁共振成像（MRI）或其他图像辅助介入放射手术期间检测和可视化活检针的三维形状和尖端位置。这项工作将与斯坦福大学医学院的介入放射学家布鲁斯丹尼尔教授的小组、斯坦福大学设计研究中心（CDR）的Mark Cutkosky教授的小组和HeartVista合作完成，用于临床成像平台软件集成。此外，我们的潜在客户和战略合作伙伴Civco，北方数字（NDI）和Hologic将提供指导和其他实物捐助，以帮助我们加快技术的开发并协助FDA的批准过程。微创手术，包括硬肿瘤活检，依赖于小型化工具和机器人辅助的进步，以减少对患者的创伤并加快愈合时间。目前的工具缺乏外科医生在开放式手术中使用的优势的实时位置意识。选择肝脏作为器官受试者是因为高度需要减少位置误差并最大限度地减少多次进针，从而改善临床结局，特别是在因基础肝脏疾病而易发生过度出血的患者中。在组织诊断中，引导对横断面成像研究中发现的异常进行活检的能力是公认的，MRI提供了许多优于其他成像方式的显著优势。随着只能与MRI协同工作的新型长效造影剂的出现，这一点更加真实。主要的具体目的是证明，一种创新的针设计部署光纤传感器的指导（在3D）和力反馈，可用于串联与MRI，以加强肝活检的进行。我们的临床和行业合作伙伴建议我们对介入手术越来越感兴趣，例如在连续MR扫描下进行的活检、消融和冷冻手术。在阶段I期间，沿沿着光纤复用的传感器被嵌入到18号活检针中，并用于提供整个针弯曲形状的实时可视化，包括针尖位置。这通过集成到同一针尖中的力传感设计特征来增强。在第二阶段，工作将扩展到通过更详细的体外工作，然后在动物模型中选择体内实验来证明可靠的形状传感。此外，第二阶段将把力传感能力与光纤布拉格光栅（FBG）和IFOS的力反馈技术相结合，以提供力反馈。这项工作将最终在一个原型MRI兼容，医生控制的针系统的图像引导肝脏程序。该技术可以适用于其他成像模式，包括超声（US）和计算机断层扫描（CT）。拟议的工作将推进机器人手术的智能针开发领域，在肿瘤学、生物成像和生物工程方面具有潜在的广泛副产品应用。

DESCRIPTION (provided by applicant): The goal of this research is to develop an innovative prototypical medical device treatment system capable of detecting and visualizing three dimensional shape and tip position of a biopsy needle during Magnetic Resonance Imaging (MRI) or other image-assisted interventional radiological procedures. This work will be done in collaboration with interventional radiologist Professor Bruce Daniel's group at the Stanford Medical School, Professor Mark Cutkosky's group at the Stanford Center for Design Research (CDR) and HeartVista, for clinical imaging platform software integration. In addition, our potential clients and strategic partners Civco, Northern Digital (NDI) and Hologic will provide guidance and other in-kind contributions to help us accelerate the development of the technology and assist in the FDA approval process. Minimally invasive procedures, including biopsies of hard tumors, rely on advances in miniaturized tools and robotic assistance to reduce trauma to patients and speed healing times. Present tools lack the real-time position awareness that surgeons use to an advantage in open surgery. The liver was chosen as an organ subject due to the high need to reduce positional error and minimize multiple needle passes, thus improving clinical outcomes, especially in patients susceptible to excessive bleeding due to underlying liver disease. The ability to guide biopsy of abnormalities seen on cross-sectional imaging studies is well recognized in tissue diagnosis, and MRI provides a number of significant advantages over other imaging modalities. This is all the more true with the advent of new long lived contrasting agents that can only work in tandem with MRI. The principal specific aim is to demonstrate that an innovative needle design deploying fiber optic sensors for guidance (in 3D) and force-feedback can be used in tandem with MRI to enhance the conduct of liver biopsies. Our clinical and industry partners advise us of a growing interest towards interventional procedures, such as biopsies, ablations, and cryosurgeries performed under continual MR scanning. During Phase I, sensors multiplexed along optical fibers were embedded into 18 gauge biopsy needles and used to provide real-time visualization of the entire needle bend shape, including the needle tip position. This was augmented by force sensing design features integrated into the same needle tip. During Phase II, the work will be extended to demonstrate reliable shape sensing through more detailed in vitro work followed by selected in vivo experiments in animal models. In addition, Phase II will integrate force sensing capability with fiber Bragg gratings (FBG) and IFOS' interrogator technology to provide force feedback. Work will culminate in a prototype MRI-compatible, physician-controlled needle system for image-guided liver procedures. The technology can be adapted to other imaging modalities, including ultrasound (US) and computer tomography (CT). The proposed work will advance the field of smart needle development for robotic surgery with potentially broad-based spin-off applications in oncology, biological imaging and bioengineering.