Vitreoretinal Surgery via Robotic Microsurgical System with Image Guidance, Force Feedback, Virtual Fixture, and Augmented Reality

项目总结/摘要 本提案的目的是扩展我们在眼内机器人介入和 手术系统（IRISS），并将其用于远程操作的玻璃体视网膜手术。虽然新技术 例如术中光学相干断层扫描（i-OCT），玻璃体视网膜外科医生仍然 在手术期间缺乏关键信息（例如，视网膜前膜和视网膜之间的距离）， 显示和反馈不足。此外，生理能力是一个限制因素，因为视网膜 是人体最小最脆弱的组织之一手术失败率在复杂 由于目前手术能力的限制，视网膜病例仍然很高（10-15%）， 这些患者失明[1-3]。 我们的团队通过内部资金和最近的R21赠款的组合开发了IRISS [4-10 (NIH/R21EY024065）。这种支持使我们的团队能够开发IRISS平台， 离体猪眼的白内障手术。我们还证明了IRISS的安全性能- 基于术前实时解剖检测和遥控操作的用于透镜移除的运动引导 玻璃体视网膜操作的能力，包括视网膜静脉插管和核心玻璃体切除术[4]。此外，委员会认为， Raven II是一种开源手术机器人系统[11-22]，由罗森在过去16年中共同开发 用于一般微创手术。在本研究中，Raven II系统的手术驾驶舱将 作为改进的机器人手术系统的用户界面的基础。累计 我们小组通过之前的工作获得的经验将从严格的角度指导拟议的研究工作 申报系统设计、开发和评价的临床要求。 本研究由三个独立、平行的轨道组成。首先，机械设计和 机器人手术系统的装配将得到改进，以实现5 µm的工具尖端位置精度， 大约比人类外科医生精确十倍[23]。其次，我们将加强外科医生的 在视网膜操作过程中通过应用高分辨率来感知和解释解剖细节的能力 (10μm），实时术中i-OCT扫描，以检测对特定玻璃体视网膜至关重要的解剖特征 程序.第三，感兴趣的手术特征将通过人机手术系统呈现给外科医生。 驾驶舱，提供创新的3D，增强现实可视化和听觉和触觉反馈。每个 该计划将通过一系列的评估程序进行评估，以确保其成功。的安全性和有效性 系统也将与没有提出的改进（机器人控制，增强的传感， 除了体模和生物眼睛模型之外，还在虚拟现实模拟器上进行增强反馈） 选择最佳评估手术结果。重要的是要注意，虽然最终目标是整合 所有这三个目标，他们的发展仍然是独立的，成功或失败的一个不影响 另一个的结果。 我们假设，一个外科医生机器人手术系统，结合了增强的传感和反馈， 丰富外科医生对解剖细节的感知和解释将提高手术安全性， 手术并发症的发生率，以改善健康结果并减少与手术相关的费用 并发症

PROJECT SUMMARY/ABSTRACT The aims of the present proposal are to extend our work with the Intraocular Robotic Interventional and Surgical System (IRISS) and augment it for teleoperated vitreoretinal surgery. Although novel technologies such as intraoperative optical coherence tomography (i-OCT) have been developed, vitreoretinal surgeons still lack critical information during surgery (e.g., the distance between pre-retinal membrane and retina) due to inadequate display and feedback. In addition, physiological capabilities are a limiting factor because the retina is one of the smallest and most delicate tissues of the human body. The rate of surgical failure in complex retinal cases remains high (10–15%) due to the limits of current surgical capabilities, thereby condemning these patients to blindness [1-3]. Our group has developed the IRISS [4-10] through a combination of internal funding and a recent R21 grant (NIH/R21EY024065). This support enabled our group to develop the IRISS platform to perform fully automated cataract surgery on ex-vivo pig eyes. We have also demonstrated the ability of the IRISS to perform safe- motion guidance for lens removal based on per-operative, real-time anatomical detection, and teleoperated capabilities for vitreoretinal maneuvers, including retinal vein cannulation and core vitrectomy [4]. Furthermore, Raven II, an open-source surgical robotics system [11-22], was co-developed by Rosen over the past 16 years for general minimally invasive surgery. In the present study, the surgical cockpit of the Raven II system will serve as the foundation of the user interface for the improved robotic surgical system. The accumulated experience of our group through this previous work will guide the proposed research effort from the stringent clinical requirements to the design, development, and evaluation of the proposed system. The present study is composed of three independent, parallel tracks. First, the mechanical design and assembly of the robotic surgical system will be improved to achieve tool-tip positional precision of 5 µm, approximately ten times more precise than a human surgeon [23]. Second, we will enhance the surgeon's abilities in sensing and interpreting anatomical details during retinal manipulation by applying high-resolution (10 µm), real-time intraoperative i-OCT scans to detect anatomical features critical to specific vitreoretinal procedures. Third, surgical features of interest will be presented to the surgeon via a human–robot surgical cockpit that provides innovative 3D, augmented-reality visualization and auditory and haptic feedback. Each aim will be assessed by a series of evaluation protocols to ensure their success. The safety and efficacy of the system will also be compared with and without the proposed improvements (robotic control, enhanced sensing, and augmented feedback) on a virtual reality simulator in addition to phantom and biological eye models chosen to best assess surgical outcome. It is important to note that while the ultimate goal is the integration of all three aims, their development remains independent and success or failure in one does not affect the outcome of another. We hypothesize that a surgeon–robot surgical system that incorporates enhanced sensing and feedback to enrich the surgeon's perception and interpretation of anatomical details will improve surgical safety and reduce the rate of surgical complications to improve health outcomes and abate the costs associated with surgical complications.