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: 8061060
• 负责人: Behzad Moslehi
• 金额: $ 19.64万
• 依托单位: INTELLIGENT FIBER OPTIC SYSTEMS CORP
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-03-01 至 2012-08-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8061060
• 关键词: Ablation; Address; Animals; Area; Automobile Driving; Awareness; Biocompatible; Biopsy; Breast; Caliber; Calibration; Cirrhosis; Clinical; Collaborations; Computer software; Contrast Media; Coupled; Cryosurgery; Development; Diagnosis; Diagnostic; Electromagnetics; Feedback; Fiber; Fiber Optics; Freedom; Goals; Hand; Healed; Hemorrhage; Image; Image Guided Biopsy; Imaging Techniques; Immunity; In Vitro; Individual; Intervention; Lesion; Life; Liver; Liver diseases; Magnetic Resonance Imaging; Malignant neoplasm of liver; Measures; Medical; Methods; Minimally Invasive Surgical Procedures; National Cancer Institute; Needle biopsy procedure; Needles; Operative Surgical Procedures; Optics; Organ; Outcome; Patients; Phase; Physicians; Positioning Attribute; Primary carcinoma of the liver cells; Procedures; Prostate; Research; Research Design; Risk; Robotics; Safety; Sampling; Scanning; Shapes; Signal Transduction; Slave; Small Business Innovation Research Grant; Speed; Surgeon; System; Techniques; Technology; Test Result; Testing; Time; Tissues; Trauma; United States National Institutes of Health; Universities; Visual; Work; abstracting; base; capsule; commercialization; cost effective; density; design; healing; image processing; imaging modality; improved; in vivo; instrument; interest; liver biopsy; medical schools; member; miniaturize; minimally invasive; operation; optical fiber; professor; prototype; radiologist; research clinical testing; research study; robot assistance; sensor; success; tissue phantom; tool; tumor

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.

描述（由申请人提供）：用于肿瘤学应用的MRI兼容光纤传感活检针智能光纤系统公司（IFOS）2363 Calle del Mundo，Santa Clara，CA 95054-1008 www.ifos.com项目概要/摘要（最多30行）微创手术，包括硬肿瘤活检，依靠小型化工具和机器人辅助的进步来减少对患者的创伤并加快愈合时间。然而，目前的工具缺乏外科医生在开放式手术中有利使用的真实的时间位置意识。在向美国国家癌症研究所（NCI）提交的第一阶段SBIR提案中，IFOS与斯坦福大学的一个跨学科团队合作，提出将实时针形确定作为针尖跟踪的基础，以及可操纵针的下游应用。IFOS和团队成员的目标是开发和测试磁共振成像（MRI）兼容的光纤传感活检针，使用叠加在MRI图像上的真实的针形信息来可视化介入区域。这解决了人们对介入性MRI手术日益增长的兴趣，例如在连续MR扫描下进行的活检、消融和冷冻手术。特别地，引导对在横截面成像研究上看到的异常进行活检的能力被公认为是实现组织诊断的高效且有效的手段，并且MRI提供了优于其他成像模式的许多显著优点，随着只能与MRI协同工作的新的长寿命造影剂的出现，更是如此。该团队的初步工作已经表明，将基于光纤布拉格光栅（FBG）技术的小型光纤（FO）力和偏转传感器集成到机器人工具中，用于形状传感和力反馈的潜力。光纤技术特别适用于MRI系统内的仪器操作，因为与传统应变仪相比，光纤技术具有抗电磁干扰（EMI）、生物相容性和上级鲁棒性。该项目旨在展示FBG传感器阵列与机器人工具（如活检针）的3D高密度集成，以提供实时的可视化针路径跟踪和操作。在第一阶段，沿沿着光纤复用的传感器将被嵌入活检针中，并用于确定整个针弯曲形状，包括针尖位置，以进行MRI引导的活检手术。将在术中采集的MR图像上注释3D针轮廓。将在模拟肝脏组织的体模对象上进行测试。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。对于易出血过多的患者尤其如此，例如，基础肝病导致的肝周出血。作为次要目标，将开发初步设计，以包括工具可操作性，这将在详细的体外和动物研究中进行，用于在第II阶段进行临床前试验和商业化分析。 公共卫生关系：本研究旨在将微型光纤形状和力传感器添加到活检针中，以提高诊断性活检和肝组织微创外科手术的精度，安全性和有效性（利用直径减小的生物相容性纤维传感器的突破性灵敏度来实现增加的成功率和患者舒适度，并且通过精确定位（减少对多个针插入的需要）疑似肿瘤来减少出血并发症，例如，使用被定位的传感器化针（产生更小的孔）。在第I阶段，将证明系统的设计可行性，该系统包括工作传感器和相关图像处理和针转向概念，应用于体模肝脏，在第II阶段，工作扩展到更先进的体外和体内工作，最终形成MRI兼容的原型，医生控制的针系统，用于图像引导肝脏手术。拟议的工作将推进机器人手术工具的智能针开发领域，并在肿瘤和非肿瘤医疗领域具有潜在的广泛副产品应用。

项目成果

MR-compatible biopsy needle with enhanced tip force sensing.

• DOI: 10.1109/whc.2013.6548393
• 发表时间: 2013-04
• 期刊: World Haptics Conference. World Haptics Conference
• 作者: Elayaperumal S;Bae JH;Christensen D;Cutkosky MR;Daniel BL;Costa JM;Black RJ;Faridian F;Moslehi B
• 通讯作者: Moslehi B