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

用于肿瘤学应用的 MRI 兼容光纤传感活检针

• 批准号: 8525173
• 负责人: Behzad Moslehi
• 金额: $ 49.48万
• 依托单位: INTELLIGENT FIBER OPTIC SYSTEMS CORP
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2016-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8525173
• 关键词: Ablation; Adopted; Animal Model; Animal Testing; Antineoplastic Agents; Awareness; Biological; Biomedical Engineering; Biopsy; Breast; Calibration; Client; Clinical; Collaborations; Communities; Computer software; Computers; Contrast Media; Coupled; Cryosurgery; Data; Destinations; Development; Diagnosis; Diagnostic; Electromagnetics; Electronics; FDA approved; Feedback; Fiber; Fiber Optics; Freedom; Future; Goals; Hand; Healed; Hemorrhage; Image; Image Guided Biopsy; Imagery; In Vitro; Life; Liver; Liver diseases; Magnetic Resonance Imaging; Marketing; Measures; Medical; Medical Device; Methods; Miniaturization; Minimally Invasive Surgical Procedures; Needle biopsy procedure; Needles; Operative Surgical Procedures; Optics; Organ; Outcome; Pathway interactions; Patients; Phase; Physicians; Positioning Attribute; Price; Procedures; Process; Prostate; Research; Research Design; Robotics; Safety; Sampling; Scanning; Series; Shapes; Signal Transduction; Speed; Surgeon; System; Technology; Testing; Time; Tissue Sample; Tissues; Trauma; Ultrasonography; Universities; Visual; Work; base; computerized data processing; cost; design; digital; flexibility; haptics; healing; image processing; imaging modality; improved; in vivo; industry partner; innovation; interest; liver biopsy; medical schools; meetings; millimeter; miniaturize; minimally invasive; new technology; oncology; operation; optical fiber; professor; prototype; public health relevance; radiologist; research study; robot assistance; sensor; technology development; tissue phantom; tomography; tool; tumor

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.

描述(申请人提供)：这项研究的目标是开发一种创新的原型医疗设备治疗系统，能够在磁共振成像(MRI)或其他图像辅助介入放射学过程中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医学院的介入放射学家布鲁斯·丹尼尔教授的团队、斯坦福大学设计研究中心(CDR)的Mark Cutkosky教授的团队以及HeartVista的临床成像平台软件集成合作完成。此外，我们的潜在客户和战略合作伙伴CIVCO、北方数据(NDI)和霍洛奇将提供指导和其他实物捐助，以帮助我们加快技术开发并协助FDA的审批过程。微创手术，包括硬性肿瘤的活组织检查，依赖于微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手术中利用的实时位置感知。选择肝脏作为器官对象是因为非常需要减少位置误差和最大限度地减少多次穿针，从而改善临床结果，特别是在容易因潜在肝病而过度出血的患者。在组织诊断中，对横断面成像研究中所见的异常进行引导活检的能力是公认的，与其他成像方法相比，MRI提供了许多显著的优势。随着新的长寿命造影剂的出现，这一点更加正确，这些造影剂只能与MRI协同工作。主要的具体目的是证明一种创新的针头设计，使用光纤传感器进行引导(3D)和力反馈，可以与MRI一起使用，以加强肝脏活检的进行。我们的临床和行业合作伙伴告诉我们，人们对介入性手术越来越感兴趣，例如在连续磁共振扫描下进行的活检、消融和冷冻手术。在第一阶段，沿着光纤多路复用的传感器被嵌入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。这一点通过集成到同一针尖的力感应设计功能得到了加强。在第二阶段，这项工作将扩大到通过更详细的体外工作来证明可靠的形状感知，然后在动物模型上进行选定的体内实验。此外，第二阶段将把力传感能力与光纤布拉格光栅(FBG)和IFOS的询问器技术相结合，以提供力反馈。这项工作将最终形成一个与MRI兼容的、医生控制的用于图像引导肝脏手术的针头系统原型。该技术还可用于其他成像方式，包括超声(US)和计算机断层扫描(CT)。这项拟议的工作将推进机器人手术的智能针开发领域，并可能在肿瘤学、生物成像和生物工程方面产生广泛的衍生应用。