SBIR Phase II: Optical Coherence Tomography(OCT)-Sensor Guided Sub-Retinal Injector

这个小企业创新研究(SBIR)第二阶段项目的更广泛/商业影响从第一阶段继续到实现新的手术工具系统，以实现安全和精确地输送干细胞和基因用于眼科应用，特别是修复和恢复视网膜变性患者的视力。视力损害发生在衰老的自然过程中，有些情况可能会通过手术解决。生活质量的相关改善和医疗保健支出的减少可以通过一个系统来解决，该系统包括增强的实时可视化技术、能够进行微小动作的工具以及通知手术行动的智能算法。这项拟议的技术通过将机器视觉结合在眼科治疗等领域来改善成像。这项SBIR第二阶段项目将推动光学相干断层扫描(OCT)引导的视网膜下注射器系统的开发。技术任务包括在身体人眼和活体猪眼上进行临床安全性和手术有效性的研究。具体地说，训练有素的外科医生将使用该系统来验证执行与视网膜下微注射程序相关的任务的能力，确定完成任务的时间，并表征错误的程度和频率。该系统将与组织学样本进行验证，并与当前徒手操作的标准进行比较。将进行优化和验证研究，以推进这项技术的翻译。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader/commercial impact of this Small Business Innovation Research (SBIR) Phase II Project continues from Phase I to realize a new surgical tool system to enable safe and precise delivery of stem cells and genes for ophthalmic application, specifically to repair and restore vision for patients with retinal degeneration. Visual impairment occurs in the natural course of aging, with some conditions potentially addressed surgically. Associated improvements in both quality of life and reduced health care expenditures can be addressed with a system involving augmented real-time visualization technology, tools capable of minute actions, and smart algorithms informing surgical actions. The proposed technology improves imaging by incorporating machine vision, with applications in ophthalmic treatment and beyond.This SBIR Phase II project will advance the development of an optical coherence tomography (OCT) guided sub-retinal injector system. Technical tasks include conducting studies to test clinical safety and procedure efficacy on both cadaveric human eyes and in-vivo porcine eyes. Specifically, trained surgeons will use the system to validate the capability to execute tasks related to subretinal microinjection procedures, determine the time to task completion, and characterize the magnitude and frequency of errors. The system will be validated with histology samples and compared to current the standard of care of freehand performance. Optimization and validation studies will take place to advance the translation of this technology.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.