OCT-Guided Free-Hand Semi-Automated Microsurgical Tool for Enhanced Retinal Surge

描述(申请人提供)：当代视网膜显微外科手术是由熟练的外科医生通过操作显微镜，利用自由手技术和手动操作的精密显微仪器进行的。我们组建了一支跨学科团队，其中包括一名临床科学家和玻璃体视网膜外科医生、一名光学设备科学家和一名系统集成商，以将我们实验室现有的和正在开发的技术转化为实际应用。为此，我们将在干模型和湿模型中进行生产和测试，并在体内验证所提出的仪器(S)。在这里，我们将在我们之前和正在进行的光纤成像、传感以及运动检测和控制方面的工作的基础上，建立一个平台，以增强外科医生可视化光学透明组织、识别和跟踪组织边缘、保持手术位置、检测与组织的早期器械接触以及评估组织渗透深度的能力。为了提供这些扩展功能，我们将把基于光学传感器的表面拓扑、运动限制和补偿技术整合到可以放入眼睛的显微手术引导工具中。该系统将能够一维实时跟踪深度、限制刀具运动、运动补偿和主动手术靶向和介入。从最初的设计，该平台将演变为一种紧凑、轻便以及符合人体工程学设计的工具，供显微外科医生自由使用。三种功能性手术工具将被集成到可视化和引导系统中，以便在工具与视网膜接触的位置提供扩展的手术能力。这将包括一个简单的微量注射插管，它将允许评估工具尖端位置、工具与视网膜的接触和视网膜穿透深度，以及将治疗剂直接输送到视网膜。第二种手术功能将是刀刃，刀轴运动和切割深度受曲面拓扑的约束，以及用于工具引导的运动限制和补偿技术。该工具的手术目的是在对视网膜损伤最小的情况下切割内界膜。减少损害的策略将是限制自动切割深度，限制刀具运动，并改善刀尖相对于视网膜表面的可视化和控制。第三种手术工具将是微型钳子，它将利用我们集成的正向公共路径光学相干断层扫描功能，以帮助识别视觉透明的手术边缘和跟踪手术进展。每种独特的工具应用都将使用我们实验室中使用的演示干模体和湿模体以及体外猪眼模型进行定量评估。在评估过程的所有环节，经验丰富的玻璃体视网膜外科医生都将对临床相关的工具进行严格的评估，并提出改进和改进建议。最后，使用兔眼模型进行体内测试和工具验证，将用于推动该技术进入临床研究准备和应用。 公共卫生相关性：这项建议通过开发功能性徒手手术工具，解决了当前玻璃体视网膜手术的根本局限性，使微外科医生能够实现手术目标，降低手术风险，并改善所有显微外科领域的结果。此外，这些功能广泛适用于其他显微外科问题，这些工具将使眼科和其他显微外科学科得到进一步发展。

DESCRIPTION (provided by applicant): Contemporary retinal microsurgery is performed by skilled surgeons through operating microscopes, utilizing free hand techniques and manually operated precision micro-instruments. We have assembled an interdisciplinary team including a clinician scientist and vitreoretinal surgeon, an optical device scientist and a systems integrator to translate existing and developing technology in our laboratories into practical application. To this end we will produce, test in dry and wet models and validate the proposed instrument(s) in vivo. Here we will build upon our previous and ongoing work in fiber optic imaging, sensing and motion detection and control to build a platform for enhancing the surgeon's ability to visualize optically transparent tissues, to identify and track tissue edges, to maintain surgical position, to detect early instrument contact with tissue and to assess depth of tissue penetration. In order to provide these extended capabilities we will incorporate our optical sensor based surface topology, motion limiting and compensation technology into a microsurgery guidance tool that can be placed into the eye. The system will be capable of one-dimensional real-time depth tracking, limitation of tool motion, motion compensation and active surgical targeting and intervention. From initial design the platform will evolve towards a compact and lightweight as well as ergonomically designed tool for free hand use by a micro-surgeon. Three functional surgical tools will be integrated into the visualization and guidance system in order to provide extended surgical capabilities at the site of tool to retina contact. These will include a simple microinjection cannula that will allow assessment of tool tip position, tool-retina contact and depth of retinal penetration as well as to directly deliver therapeutic agents into the retina. The second surgical function will be a surgical blade with tool axis motion and incision depth constrained by surface topology as well as motion limiting and compensation technology utilized for tool guidance. The surgical objective of the tool is to incise the internal limiting membrane with minimal damage to the underlying retina. The strategy for minimizing damage will be to constrain automated cut depth, to limit tool motion and to improve visualization and control of the tool tip relative to the retinal surface. The third surgical tool will be a micro-forceps that will utilize our integrated forward directed common-path optical coherence tomography function in order to assist in identifying visually transparent surgical edges and in tracking surgical progress. Each unique tool application will be quantitatively evaluated using demonstrative dry and wet phantoms in use in our laboratory as well as the ex vivo porcine eye model. At all points in the evaluation process an experienced vitreoretinal surgeon will critically evaluate and propose clinically relevant tool refinements and modifications. Finally, in vivo testing and tool validation, using a rabbit eye model, will be used to advance the technology to a clinical research ready, application. PUBLIC HEALTH RELEVANCE: This proposal addresses fundamental limitations in current vitreoretinal surgery by developing functional free-hand surgical tools that could empower micro-surgeons to achieve surgical objectives, diminish surgical risk and improve outcomes in all microsurgical fields. Further, these capabilities are broadly applicable in other microsurgical problems, and the tools will enable further advances both for ophthalmology and for other microsurgical disciplines.