Optically Actuated Needles for Oncological Applications

用于肿瘤学应用的光驱动针

• 批准号: 9098643
• 负责人: Richard J Black
• 金额: $ 73.91万
• 依托单位: INTELLIGENT FIBER OPTIC SYSTEMS CORP
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-12 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9098643
• 关键词: Address; Air; Algorithms; Alloys; Animals; Area; Back; Biopsy; Brachytherapy; Caliber; Cannulas; Clinical; Clinical Research; Collaborations; Complex; Development; Devices; Effectiveness; Ethylene Oxide; Evaluation; Feedback; Fiber Optics; Fluoroscopy; Freedom; Hand; Hardness; Health; Hemorrhage; Hour; Human; Image; Imaging Techniques; In Situ; Intervention; Lasers; Lateral; Lead; Liver; Magnetic Resonance Imaging; Magnetism; Measurement; Measures; Mechanics; Medical; Memory; Methods; Modeling; Motion; Motor; Needle biopsy procedure; Needles; Obstruction; Operative Surgical Procedures; Optics; Organ; Patients; Performance; Phase; Physicians; Power Sources; Procedures; Property; Prostate; Protocols documentation; Proxy; Reaction; Research; Research Design; Robotics; Rotation; Route; Safety; Series; Shapes; Small Business Innovation Research Grant; Software Design; Speed; Sterilization; Structure; Surface; Surgeon; System; Techniques; Technology; Temperature; Tendon structure; Testing; Time; Tissues; Training; Transition Temperature; Ultrasonography; Validation; Variant; Work; base; biomaterial compatibility; bone; clinical efficacy; cold temperature; commercialization; conditioning; design; dexterity; flexibility; image guided; image guided intervention; imaging modality; improved; in vivo; innovation; instrumentation; irritation; medical schools; minimally invasive; novel; novel strategies; operation; patient safety; prevent; prostate biopsy; prototype; research study; soft tissue; success; tissue phantom; tool; tumor; user-friendly

DESCRIPTION (provided by applicant): In this FastTrack Phase I/II SBIR application, IFOS, in collaboration with the Stanford Center for Design Research (CDR) proposes to develop and validate an actively steered, photo-actuated, small-caliber needle for precise imaging-assisted percutaneous procedures. This innovation specifically addresses the need for precise needle placement in procedures targeting deep tissue, where routes of entry are restricted due to anatomical obstructions and the need to avoid vital organs. The proposed active steering can compensate for the deflection encountered during needle insertion into soft tissue, which becomes increasingly significant as the path to the target lengthens. Such deviations from the planned path can result in multiple reinsertions, adding to patient discomfort and procedure time, and compromising the effectiveness of minimally invasive procedures. The active steering concept is based on optical activation of a shape memory alloy (SMA) embedded within a flexible stylet. Design features compatible with standard needle tips and outer cannula sheaths will be employed. Unlike other techniques based on electrical or magnetic actuation, the proposed approach is compatible with all major imaging techniques, including MRI. By using fiber-optic connections, the stand-off distance from the laser power source to the needle can be greater than that for actuation motors required for tendon approaches. The technique requires minimal power input and can be implemented in a user-friendly hand-held biopsy needle system. While the basic needle concept does not rely on complex algorithms and robotic needle insertion systems, the basic design includes a streamlined back-end that affords a ready connection to more complex instrumentation, including advanced online-imaging interface capabilities. In prior work, bending rates of over 2� per second have been repeatably achieved in phantoms that mimic the properties of human prostate tissue. Also, the collateral temperature rise in surrounding tissue was shown to be minimal, effectively eliminating thermal damage as a concern. The Phase I effort is designed to demonstrate still greater deflection efficiency using various needle insertion strategies in ex vivo prostate tissue, using a novel approach involving low-transition-temperature SMAs and optimized superelastic biopsy needle structures and control. This work will lead to further development activities in Phase II, including thinner needl designs, a console design, and a closed-loop control system that enables real-time needle curvature and in situ tissue reaction force measurements. In Phase II, we also will investigate steering protocols that would take advantage of axial rotation and other known passive control strategies, thereby adding bending degrees-of freedom and dexterity to the needle system. These studies will culminate in a series of in vivo experiments, targeting prostate biopsy and brachytherapy procedures under imaging modalities such as ultrasound and MRI, to establish key clinical efficacy and safety parameters, and validate practical/clinical aspects for facilitatig FDA approval and the successful introduction of the new active needle to end users.

描述（由申请人提供）：在本FastTrack I/II期SBIR申请中，IFOS与斯坦福大学设计研究中心（CDR）合作，拟开发并确认用于精确成像辅助经皮手术的主动转向、光驱动、小口径针头。这一创新特别解决了在针对深部组织的手术中对精确针放置的需求，其中由于解剖学障碍和避免重要器官的需要，进入路径受到限制。所提出的主动转向可以补偿在针插入到软组织中期间遇到的偏转，该偏转随着到目标的路径变长而变得越来越显著。这种偏离计划路径的情况可能导致多次重新插入，增加患者不适和手术时间，并损害微创手术的有效性。主动转向概念基于嵌入柔性管芯针内的形状记忆合金（SMA）的光学激活。将采用与标准针尖和外套管鞘兼容的设计特征。与基于电或磁致动的其他技术不同，所提出的方法与所有主要成像技术兼容，包括MRI。通过使用光纤连接，从激光功率源到针的间距可以大于肌腱方法所需的致动电机的间距。该技术需要最小的功率输入，并且可以在用户友好的手持式活检针系统中实现。虽然基本的针头概念不依赖于复杂的算法和机器人针头插入系统，但基本设计包括一个流线型后端，可随时连接到更复杂的仪器，包括先进的在线成像接口功能。在先前的工作中，在模拟人类前列腺组织特性的模型中，已经重复实现了每秒超过2英寸的弯曲率。此外，周围组织的附带温升被证明是最小的，有效地消除了热损伤作为一个问题。第一阶段的努力旨在证明更大的偏转效率使用各种针插入策略在离体前列腺组织，使用一种新的方法，涉及低转变温度SMA和优化的超弹性活检针结构和控制。这项工作将导致第二阶段的进一步开发活动，包括更薄的针设计，控制台设计和闭环控制系统，使实时针曲率和原位组织反作用力测量。在第二阶段，我们还将研究转向协议，将利用轴向旋转和其他已知的被动控制策略，从而增加弯曲度的自由度和灵活性的针系统。这些研究将在一系列体内实验中达到高潮，目标是在超声和MRI等成像模式下进行前列腺活检和近距离放射治疗程序，以确定关键的临床疗效和安全性参数，并验证实用/临床方面，以促进FDA批准并将新的有源针成功引入最终用户。