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: 8917949
• 负责人: Behzad Moslehi
• 金额: $ 24.73万
• 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 2017-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8917949
• 关键词: Ablation; Adopted; Animal Model; Animal Testing; Antineoplastic Agents; Awareness; Biological; Biomedical Engineering; Biopsy; Breast biopsy; 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; Health; 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; 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; cost; design; digital; flexibility; haptics; healing; image guided; image processing; imaging modality; imaging platform; improved; in vivo; industry partner; innovation; interest; liver biopsy; medical schools; meetings; millimeter; miniaturize; minimally invasive; new technology; oncology; operation; optical fiber; professor; prostate biopsy; prototype; radiologist; research study; robot assistance; sensor; signal processing; 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（由申请人提供）：这项研究的目的是开发一种创新的原型医疗设备处理系统，能够在磁共振成像（MRI）或其他图像辅助介入的介入放射学过程中检测和可视化活检针头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（Bruce Daniel）小组合作完成，斯坦福大学设计研究中心（CDR）和HeartVista教授的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，Northern Digital（NDI）和Hologic将提供指导和其他实物贡献，以帮助我们加速技术的发展并协助FDA批准过程。最小的侵入性程序，包括硬性肿瘤活检，依赖于小型工具和机器人援助的进步来减少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使用优势的实时位置意识。由于高度减少位置误差并最大程度减少多个针头的需求，因此选择肝脏作为器官受试者，从而改善了临床结局，尤其是在因潜在的肝病而容易出血的患者中。在组织诊断中可以很好地认识到在横截面成像研究中观察到异常的活检的能力，而MRI比其他成像方式具有许多重要的优势。随着新的长期生活对比代理的出现，只能与MRI协同作用，这是更真实的。主要的特定目的是证明，可以与MRI同时使用创新的针头设计用于指导的光纤传感器（3D）和力反馈，以增强肝脏活检的行为。我们的临床和行业合作伙伴向我们建议我们对介入的介入程序的兴趣日益增长，例如在不断扫描的MR扫描下进行的活检，消融和冷冻效果。在第一阶段，将沿光纤沿光纤的传感器嵌入18量规活检针中，并用于提供整个针头形状的实时可视化，包括针尖位置。力传感设计功能集成到同一针头尖端，从而增加了这一点。在II阶段期间，将扩展工作，以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，第二阶段将将力传感能力与纤维bragg光栅（FBG）和IFOS的询问器技术相结合，以提供力反馈。工作将在原型MRI兼容的，由医师控制的针头系统中达到最终形象，用于图像引导的肝脏程序。该技术可以适应其他成像方式，包括超声（US）和计算机断层扫描（CT）。拟议的工作将通过潜在的肿瘤学，生物成像和生物工程中的基于广泛的衍生应用来推动机器人手术的智能针头开发领域。