Optically Actuated Needles for Oncological Applications

描述（由申请人提供）：在这个快速通道I/II期SBIR申请中，IFOS与斯坦福设计研究中心（CDR）合作，提出开发和验证一种主动导向、光驱动、小口径的针，用于精确的成像辅助经皮手术。这项创新特别解决了在针对深层组织的手术中对精确针头放置的需求，在深层组织中，由于解剖障碍和需要避开重要器官，进入路径受到限制。所提出的主动转向可以补偿针头插入软组织时遇到的偏转，随着到达目标的路径延长，这种偏转变得越来越重要。这种偏离计划路径可能导致多次重新插入，增加患者的不适和手术时间，并损害微创手术的有效性。主动转向概念是基于嵌入在柔性样式中的形状记忆合金（SMA）的光学激活。将采用与标准针尖和外套管兼容的设计特点。与其他基于电或磁驱动的技术不同，该方法与包括MRI在内的所有主要成像技术兼容。通过使用光纤连接，从激光电源到针头的距离可以大于肌腱接近所需的驱动电机的距离。该技术需要最小的功率输入，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的后端，可以随时连接到更复杂的仪器，包括先进的在线成像接口功能。在之前的工作中，已经在模拟人类前列腺组织特性的模型中重复实现了超过每秒2¿的弯曲速率。此外，周围组织的侧枝温升被证明是最小的，有效地消除了热损伤的担忧。第一阶段的工作旨在通过使用低过渡温度sma和优化的超弹性活检针结构和控制的新方法，在离体前列腺组织中使用各种针插入策略来证明更高的挠曲效率。这项工作将导致第二阶段的进一步开发活动，包括更细的针头设计，控制台设计和闭环控制系统，可以实现实时针头曲率和原位组织反力测量。在第二阶段，我们还将研究转向方案，该方案将利用轴向旋转和其他已知的被动控制策略，从而增加针系统的弯曲自由度和灵活性。这些研究将在一系列体内实验中达到高潮，针对前列腺活检和成像模式下的近距离治疗程序，如超声和MRI，以建立关键的临床疗效和安全性参数，并验证实际/临床方面，以促进FDA批准和向最终用户成功引入新的活性针。

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.