SBIR Phase I: A hand-held retinal imager that incorporates a flat lens and total internal reflection illumination

这个SBIR第一阶段项目的更广泛的商业影响是促进在主要(非眼科医生)医疗点进行视网膜筛查。糖尿病视网膜病变是导致20-74岁美国人失明的主要原因。为数百万高危患者提供高效且经济实惠的视网膜筛查既是当务之急，也是一项紧迫的工程挑战。该项目将测试一种独特的透镜设计和成像方法，作为构建直观、负担得起的手持视网膜成像仪的第一步，专门针对初级保健医生和非眼科医生保健提供者。在初级医疗点启用广泛的糖尿病视网膜病变筛查将为以前未得到充分服务的患者群体带来预防性筛查，包括贫穷的城市和农村地区。允许初级保健医生提供这些服务将减轻负担过重的眼科专家的工作量。解放专家的时间和资源以更有效地利用也将降低医疗保健系统的成本。该项目旨在开发一种新的透镜几何结构，使成像过程中能够更有效地照明视网膜。该公司的创新和改进的方法将减少成像故障以及设备尺寸和成本，从而提高可靠性、视网膜筛查效率和可及性。这个项目建立在对视网膜筛查的陷阱和失败模式的经验洞察的基础上。具有新几何结构的透镜将被制成原型，透镜和照明系统的光学性能将使用物理和生物眼睛模型进行测试。简而言之，计算模型将被用来预测用5 mm口径挑战的候选透镜几何形状的特性(例如，视网膜照明的一致性)。接下来，将组装光学和电子部件的物理原型，然后使用眼睛的物理和生物模型进行概念验证测试，以将原型镜片的性能与预测值进行比较。这些关键的结果将指导公司努力改进其设计，从原型过渡到生产模式，以实现成本效益的制造，并在将这种手持视网膜成像仪推向临床的过程中计划试点试验。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 SBIR Phase I project is to facilitate retinal screening at primary (non-ophthalmologist) points of care. Diabetic retinopathy is the leading cause of blindness in Americans aged 20-74. Delivering efficient and cost-effective retinal screening to the millions of at-risk patients is both imperative and a pressing engineering challenge. This project will test a unique lens design and imaging method as the first steps toward building an intuitive, affordable hand-held retinal imager specifically targeted to primary care physicians and non-ophthalmologist healthcare providers. Enabling widespread diabetic retinopathy screening at primary points of care will bring preventive screening to previously under served patient populations, including poor urban and rural areas. Allowing primary care physicians to offer these services will reduce the workload for over-burdened eye specialists. Freeing up specialists’ time and resources to be utilized more efficiently will also reduce costs to the healthcare system. This project seeks to develop a novel lens geometry that will enable more efficient illumination of the retina during imaging. The company's innovative and improved methodology will decrease imaging failure along with device size and cost, resulting in increased reliability, retinal screening efficiency, and accessibility. This project builds on empirical insights into the pitfalls and failure modes of retinal screening. Lenses with the novel geometry will be prototyped, and the optical performance of the lens and illumination system will be tested using physical and biological eye models. Briefly, computational modeling will be used to predict the properties (e.g., uniformity of retinal illumination) of candidate lens geometries challenged with a 5 mm aperture. Next, a physical prototype for the optical and electronic components will be assembled, followed by proof-of-concept tests with physical and biological models of the eye to compare the performance of prototype lenses to predicted values. These critical results will guide the company’s efforts to refine its design, transition from prototype to production model for cost-effective manufacturing, and to plan pilot trials as it moves this hand-held retinal imager toward the clinic.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.