Enabling technology for image-guided robot-assisted sub-retinal injections

项目摘要 本提案的目标是设计、开发和评估一种新型的临床兼容手术平台 用于增强视网膜外科医生对视网膜下区域提供治疗的能力。高效、安全、可重复 递送方法将能够安全和精确地递送干细胞、纳米颗粒和基因疗法， 流行的眼部疾病，包括但不限于与视网膜相关的黄斑变性（AMD）。拟议 协作手术机器人利用由4D术中光学引导的力传感仪器 相干断层扫描（4D-iOCT）成像，用于直观的外科医生-机器人-患者界面。 公认的是，精确的手术进入视网膜下和视网膜内空间将提供新颖的治疗方法。 许多流行性眼部疾病的治疗选择; AMD仍然是导致 老年人的失明及其高昂的护理费用使其成为一种战略性的原型条件， 治疗的进步在过去的十年中，干细胞和基因治疗已经被广泛探索， 治疗AMD。初步结果表明有希望的安全性特征，并表明对以下疾病的潜在疗效： 两者然而，将这些方法转化为临床护理标准在一定程度上受限于缺乏一种有效的方法。 本发明提供了一种容易、安全、可重复和有效地将完全有活力的试剂递送到视网膜下腔的方法。 通过推进机器人技术，我们寻求安全可靠地增强对视网膜下腔的访问， 允许在流行性视网膜疾病的情况下靶向递送新的治疗剂， AMD.我们的目标是：（1）开发和评估临床兼容的合作控制机器人助手， 实现精确的工具操作。增强的功能将允许精确的目标交付，适当的 细胞和遗传货物在视网膜下腔中的定向，以及增强治疗性生物制品的存活。 智能体;（2）开发并集成一种新的路径规划功能到工作站，这将有助于机器人- 辅助视网膜下注射：利用实时术中3D OCT图像，我们将检测和跟踪先前的 隐形视网膜下显微结构，优化入路轨迹，实现安全、可控和精确 视网膜下注射到目标空间。虚拟固定装置将被纳入设计，以避免危险 （3）系统集成和临床前评估：我们将开发辅助控制方案， 融合由力传感仪器捕获的工具-组织相互作用和视觉 OCT系统提供的信息。此外，将新技术与当前手术 技术，在体内，将进行证明我们的方法的可行性。 这种高度创新的系统将使外科医生能够在无震颤的情况下进行复杂的操作。 环境具有比以前更高的精度水平，并具有感知工具到组织的能力 以前无法察觉的互动。我们设想这一发展是合乎逻辑的下一步， 人、机器和计算机的集成，以实现前所未有的显微手术操作。

Project Summary The goal of this proposal is to design, develop and evaluate a novel clinically compatible surgical platform for enhancing the retina surgeon's ability to provide therapy to the subretinal domain. Efficient, safe, reproducible delivery methods would enable safe and precise delivery of stem cell, nanoparticle and gene therapies for prevalent ocular diseases including but not limited to Age-related Macular Degeneration (AMD). The proposed cooperative surgical robot utilizes force-sensing instruments that are guided by 4D intraoperative Optical Coherence Tomography (4D-iOCT) imaging for intuitive surgeon-robot-patient interfaces. It is recognized that precise surgical access to the subretinal and intraretinal spaces would provide novel treatment options for a number of prevalent ocular diseases; the fact that AMD remains the leading cause of blindness in the elderly as well as its extraordinary cost of care makes it a strategic prototype condition for advances in therapy. During the last decade, stem cells and gene therapy have been extensively explored as treatments for AMD. Preliminary results indicate a promising safety profile, and suggest potential efficacy for both. However, translation of these methods into a clinical standard of care has in part, been limited by lack of a method to easily, safely, reproducibly and effectively deliver fully viable agents to the subretinal space. By advancing robotic technology, we seek to safely and reliably enhance access to the subretinal space to allow for the targeted delivery of novel therapeutic agents in the setting of prevalent retinal diseases, such as AMD. Our aims are: (1) Develop and evaluate a clinically compatible cooperative-controlled robotic assistant to enable precise tool manipulation. The enhanced functionality will allow for precise targeted delivery, proper orientation of cells and genetic cargo in the subretinal space, and enhanced survival of therapeutic biological agents; (2) Develop and integrate a novel path planning function to the workstation that will facilitate robot- assisted subretinal injections: utilizing real-time intraoperative 3D OCT images we will detect and track previously invisible subretinal microstructure, optimize approach trajectories to achieve safe, controlled and precise subretinal injections into the target space. Virtual fixtures will be incorporated into the design to avoid dangerous motions; (3) System integration and preclinical evaluation: we will develop assistive control schemes and workflow that fuse the tool-tissue interactions captured by the force-sensing instruments and the visual information provided by the OCT system. In addition, comparison of the new technology against current surgical techniques, in vivo, will be conducted to demonstrate the feasibility of our approach. This highly innovative system will enable surgeons to perform complex maneuvers in a tremor free environment with a higher level of precision than previously possible and with the ability to sense tool-to-tissue interactions that have been previously imperceptible. We envision this development as a logical next step in the integration of man, machine and computer for the performance of unprecedented microsurgical maneuvers.