Ocular Therapeutic Delivery Through Real-time Endoscopic B-scan OCT-guided Tools and Robotic Assistance

通过实时内窥镜 B 扫描 OCT 引导工具和机器人辅助进行眼部治疗

• 批准号: 10238850
• 负责人: KAREN MARGARET JOOS
• 金额: $ 38.19万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10238850
• 关键词: Accelerometer; Address; Affect; Aging; Anatomy; Biological; Blindness; Cell Therapy; Cells; Climacteric; Clinical Trials; Disease; Economic Burden; Evaluation; Extravasation; Funding; Future; Genes; Goals; Image; Image-Guided Surgery; Inherited; Injections; Investigational New Drug Application; Investigational Therapies; Laparoscopic Surgical Procedures; Laser In Situ Keratomileusis; Location; Manuals; Measurement; Measures; Methods; Microscope; Molecular; Monitor; Motion; Needles; Operative Surgical Procedures; Optical Coherence Tomography; Perception; Physiological; Population; Preventive; Procedures; Protocols documentation; Reflux; Research; Research Personnel; Resources; Retina; Retinal Diseases; Retinal Perforations; Robot; Robotics; Role; Safety; Scanning; Supportive care; Surgeon; System; Techniques; Technology; Testing; Therapeutic; Therapeutic Agents; Therapeutic procedure; Thick; Time; Tissues; Translating; Tremor; Vision; Vision Disorders; Visual impairment; Visualization; Vitrectomy; Work; age related; cost; cost effective treatment; design; gene replacement therapy; gene therapy; image guided; improved; infancy; instrument; minimally invasive; negative affect; new technology; novel; porcine model; pre-clinical; preservation; prevent; regenerative; robot assistance; robotic system; safety outcomes; skills; stem cells; subretinal injection; telemanipulation; therapeutic target; tool

Project Summary Therapeutic protocols using gene therapy or stem cells for treating ocular diseases are still in their infancy, but promise a paradigm shift in treating a variety of visual disorders. Functional cellular preservation is expected to reduce progression of vision impairment, thereby reducing suffering and economic burden. With an aging world population, developing efficient and cost-effective therapies for age-related ocular diseases have become critical. Although less common, inherited retinal disorders cause untreatable vision loss in the young with only supportive care available. New molecular therapeutic agents for these and other blinding diseases present a potential for sight preservation. However, robust translatable injection techniques to enable pre-clinical researchers and clinicians to visualize and accurately deliver therapies to the favored subretinal location are lacking. A safe and accurate subretinal injection procedure is hampered by lack of simultaneous real-time visualization of the cross-sectional retinal layers and the needle tip. Moreover, subretinal injections require extreme accuracy and steadiness beyond the physiological tremor of most surgeons. Due to these perception and technical challenges, the current injection technique may disrupt adjacent anatomical structures. In addition, agent or cells may be injected into the incorrect layer or reflux through the internal retinal hole into the vitreous cavity. Such complications may negatively affect potential vision preservation. The reliability and safety of delivering ocular therapeutics are ongoing FDA concerns, which may affect advancement of the dramatically increasing treatments with >80 Investigational New Drug applications in 2015. Our goal is to directly address the FDA concerns by offering solutions to the critical accuracy barriers of perception and maneuverability by using a novel concept of a direct approach for subretinal injections using needles equipped with B-scan optical coherence tomography (OCT)-guided visualization and by using robotic assistance with online segmentation for localized therapeutic delivery. Our main hypothesis is that the proposed approach with technological augmentation of surgeons’ visualization and manipulation skills for subretinal injections will enable a less invasive, more accurate, and safer therapeutic delivery procedure for ocular diseases. Aim I of our research includes the merging of novel B-scan OCT-guided needles with robotic assistance to achieve therapeutic delivery with minimal anatomical disruption. Aim II of our research includes testing our hypothesis by translating our systems to a preclinical porcine model to evaluate the role of visualization and maneuver augmentation in improving accuracy and time efficiency. This proposed work will develop efficacious OCT image-guided robotic-assisted surgical technologies and methods to enable the accurate delivery, of biologicals being discovered for future preventive, therapeutic and regenerative ocular treatments, with reduced procedural complexity and time.

项目摘要 使用基因疗法或干细胞治疗眼部疾病的治疗方案仍处于起步阶段，但 保证在治疗各种视觉障碍时会发生范式转变。功能性细胞制剂有望 减少视力障碍的进展，从而减轻痛苦和经济负担。随着老化的世界 人口，为与年龄有关的眼部疾病发展有效且具有成本效益的疗法已成为 批判的。尽管不常见，但遗传残留障碍导致年轻人的视力丧失，仅 提供支持护理。这些和其他盲目疾病的新分子治疗剂呈现 视力保存的潜力。但是，可靠的可翻译注射技术可实现临床前 研究人员和临床医生可视化并准确地将疗法运送到视网膜下部位置 缺乏。由于缺乏同时的实时，可以阻碍安全准确的视网膜下注射程序 横截面永久层和针尖的可视化。此外，视网膜下注射需要 超出大多数外科医生的物理树的极端准确性和稳定性。由于这些感知 和技术挑战，当前的注射技术可能会破坏相邻的解剖结构。在 此外，可以将试剂或细胞注入不正确的层或通过内部残留孔反射到 玻璃腔。这种并发症可能会对潜在的视力保存产生负面影响。可靠性和 提供眼疗的安全是FDA的持续关注，这可能会影响 2015年通过> 80种调查新药应用动态增加治疗方法。我们的目标是 通过为关键的感知准确性障碍提供解决方案，直接解决FDA的关注 通过使用针对视网膜下注射的直接方法的新颖概念使用针头 使用B扫描光学相干断层扫描（OCT）指导的可视化，并使用机器人辅助 在线细分，用于局部治疗交付。我们的主要假设是拟议的方法 随着外科医生的可视化和视网膜下注射的操纵技巧的技术增强 为眼部疾病启用侵入性较小，更准确，更安全的治疗性递送程序。目的我 我们的研究包括与机器人辅助的新型B-Scan Oct指导针的合并以实现 治疗性递送，最小的解剖学破坏。我们研究的目标II包括检验我们的假设 通过将我们的系统转换为临床前猪模型，以评估可视化和操纵的作用 提高准确性和时间效率的增强。这项拟议的工作将提高有效的OCT 图像引导的机器人辅助手术技术和方法，以实现准确的传递， 发现了用于未来预防，治疗和再生眼疗法的生物学家 降低程序复杂性和时间。