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

这项小企业创新研究（SBIR）二期项目的更广泛/商业影响将继续从一期开始，实现一种新的手术工具系统，以安全、精确地输送用于眼科应用的干细胞和基因，特别是用于修复和恢复视网膜变性患者的视力。视力障碍发生在自然衰老过程中，有些情况可能通过手术解决。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、能够进行微小操作的工具和通知手术操作的智能算法。提出的技术通过结合机器视觉改善成像，在眼科治疗和其他领域的应用。该SBIR二期项目将推进光学相干断层扫描（OCT）引导视网膜下注入系统的开发。技术任务包括进行研究，以测试人体尸体眼睛和活体猪眼睛的临床安全性和程序有效性。具体来说，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显微注射程序相关的任务的能力，确定任务完成的时间，并表征错误的大小和频率。该系统将用组织学样本进行验证，并与目前的徒手性能护理标准进行比较。将进行优化和验证研究，以推进该技术的翻译。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值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.