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

描述(由申请人提供)：磁共振兼容的光纤传感活检针用于肿瘤学应用智能光纤系统公司(IFOS)2363Calle del Mundo，Santa Clara，CA 95054-1008www.ifos.com项目摘要/摘要(最多30行)微创程序，包括硬肿瘤的活组织检查，依赖于微型工具和机器人辅助的进步，以减少对患者的创伤和加快愈合时间。然而，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。在提交给国家癌症研究所(NCI)的这份第一阶段SBIR提案中，IFOS与斯坦福大学的一个跨学科团队合作，建议展示实时针形确定作为针尖跟踪的基础，以及可引导针的下游应用。特别是，IFOS和团队成员的目标是开发和测试与磁共振成像(MRI)兼容的光纤传感活检针，使用叠加在MRI图像上的实时针形信息来可视化介入区域。这解决了人们对介入性MRI程序的日益增长的兴趣，例如在连续MR扫描下进行的活检、消融和冷冻外科手术。特别是，引导横断面成像研究中所见异常的活检的能力被公认为是实现组织诊断的有效和有效的手段，与其他成像方法相比，MRI提供了许多显著的优势，尤其是随着新的长寿命造影剂的出现，这些造影剂只能与MRI协同工作。该团队的初步工作已经表明，将基于光纤布拉格光栅(FBG)技术的微型光纤(FO)力和挠度传感器集成到机器人工具中进行形状传感和力反馈具有潜力。与传统应变计相比，光纤技术具有抗电磁干扰(EMI)、生物兼容性和卓越的稳健性，特别适合于MRI系统中的仪器操作。拟议的项目旨在展示将FBG传感器阵列集成到活检针等机器人工具中的3D、高密度集成，以提供可视化的针道跟踪和实时操作。在第一阶段，沿光纤多路复用的传感器将被嵌入超薄活检针中，并用于确定整个针头弯曲形状，包括针尖位置，用于MRI引导的活检程序。3D针轮廓将在术中获得的MR图像上进行注释。测试将在模拟肝脏组织的幽灵物体上进行。选择肝脏作为器官受试者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。尤其是容易出血过多的患者，例如，由于潜在的肝病而导致的肝周出血。作为次要目标，将开发包括工具可操作性的初步设计，这将在第二阶段进行详细的体外和动物研究，用于铺设临床前测试和商业化分析。 与公共卫生相关：本研究旨在向活检针中添加微型光纤形状和力传感器，以提高诊断活检和肝组织微创手术的精确度、安全性和有效性(利用直径较小的生物兼容光纤传感器的突破性敏感性，以提高成功率和患者舒适度，并通过精确定位可疑肿瘤(减少对多根针插入的需求)来减少出血并发症，例如，使用超薄(创建更小的孔)的感应针)。在第一阶段，将论证一种系统的设计可行性，该系统包括工作传感器和相关的图像处理和针头转向概念，应用于幻影肝脏，在第二阶段工作扩展到更高级的体外和体内工作，最终形成用于图像引导肝脏手术的与MRI兼容的医生控制的针头系统原型。这项拟议的工作将推进机器人手术工具的智能针头开发领域，可能会在肿瘤和非肿瘤医学领域产生广泛的副产品应用。

DESCRIPTION (provided by applicant): MRI Compatible Fiber Optically Sensorized Biopsy Needles for Oncological Applications Intelligent Fiber Optic Systems Corporation (IFOS) 2363 Calle del Mundo, Santa Clara, CA 95054-1008 www.ifos.com PROJECT SUMMARY/ABSTRACT (MAXIMUM 30 LINES) 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. However, present tools lack the real- time position awareness that surgeons use to an advantage in open surgery. In this Phase I SBIR proposal to the National Cancer Institute (NCI), IFOS, in collaboration with an interdisciplinary team at Stanford University, proposes to demonstrate real-time needle shape determination as a basis for needle tip tracking, as well as downstream applications for steerable needles. In particular, IFOS and team members aim to develop and test magnetic resonance imaging (MRI)-compatible, optical fiber-sensorized, biopsy needles using real- time needle shape information superposed on MRI images to visualize the intervention area. This addresses the growing interest towards interventional MRI procedures, such as biopsies, ablations, and cryosurgeries performed under continual MR scanning. In particular, the ability to guide biopsy of abnormalities seen on cross-sectional imaging studies is well recognized as an efficient and effective means of achieving a tissue diagnosis, and MRI provides a number of significant advantages over other imaging modalities, all the more so with the advent of new long lived contrasting agents that can only work in tandem with MRI. Preliminary work by the team has already indicated the potential of integrating miniaturized fiber optic (FO) force and deflection sensors based on optical fiber Bragg grating (FBG) technology into robotic tools for shape sensing and force feedback. Fiber optic techniques are especially suited for instrument manipulation within MRI systems due to their immunity to electromagnetic interference (EMI), bio-compatibility and superior robustness as compared with conventional strain gauges. The proposed project aims to demonstrate 3D, high-density integration of FBG sensor arrays into robotic tools such as biopsy needles to provide visual needle path tracking and manipulation in real-time. During Phase I, sensors multiplexed along optical fibers will be embedded into ultrathin biopsy needles and used to determine the entire needle bend shape, including the needle tip position, for MRI-guided biopsy procedures. The 3D needle profiles will be annotated over MR images acquired intraoperatively. Testing will be performed on phantom objects mimicking liver tissue. Liver is chosen as an organ subject due to the high need to reduce positional error and minimize multiple needle passes, thus improving clinical outcomes. This is especially the case in patients susceptible to excessive bleeding, e.g., perihepatic bleeding due to underlying liver disease. As a secondary objective, preliminary designs will be developed to include tool maneuverability, which will be carried into detailed in-vitro and animals studies used to lay out pre-clinical testing and commercialization analysis during Phase II. PUBLIC HEALTH RELEVANCE: This research aims to add miniature fiber-optic shape and force sensors to biopsy needles in order to enhance the precision, safety and efficacy of diagnostic biopsy and minimally invasive surgical procedures on liver tissue (exploiting the breakthrough sensitivity of reduced diameter biocompatible fiber sensors to enable increased success rates and patient comfort, and reduced bleeding complications by precision targeting (reduced need for multiple needle insertions) of suspected tumors, for example, with sensorized needles that are ultrathin (create smaller holes)). During Phase I, design feasibility will be demonstrated for a system that includes working sensors and related image processing and needle steering concepts, applied to phantom livers, with the work extended to more advanced in vitro and in vivo work during Phase II, culminating in a prototype MRI compatible, physician- controlled needle system for image-guided liver procedures. The proposed work will advance the field of intelligent needle development for robotic surgery tools with potentially broad-based spin-off applications for both oncological and non-oncological medical fields.