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

SBIR 第一阶段：手持式视网膜成像仪，配有平面透镜和全内反射照明

• 批准号: 1941226
• 负责人: Eric Hassey
• 金额: $ 22.43万
• 依托单位: PREVENTA MEDICAL CORPORATION
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-01 至 2021-04-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1941226&HistoricalAwards=false
• 关键词: SBIR; Phase; hand; held; retinal

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.

该SBIR I期项目的更广泛/商业影响是促进初级（非眼科医生）护理点的视网膜筛查。糖尿病性视网膜病变是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具有成本效益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、经济实惠的手持式视网膜成像仪的第一步，该成像仪专门针对初级保健医生和非眼科医生的医疗保健提供者。 在初级保健点进行广泛的糖尿病视网膜病变筛查将为以前服务不足的患者群体，包括贫困的城市和农村地区，带来预防性筛查。允许初级保健医生提供这些服务将减少负担过重的眼科专家的工作量。释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形状，使成像过程中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失败沿着设备尺寸和成本，从而提高可靠性，视网膜筛查效率和可访问性。该项目建立在对视网膜筛查的陷阱和失败模式的经验性见解的基础上。将制作具有新几何形状的透镜原型，并使用物理和生物眼睛模型测试透镜和照明系统的光学性能。简而言之，计算建模将用于预测性质（例如，视网膜照明的均匀性）。接下来，将组装光学和电子组件的物理原型，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。这些重要成果将指导该公司努力完善其设计，从原型过渡到生产模式，以实现成本效益的制造，并计划将这种手持式视网膜成像仪推向临床的试点试验。该奖项反映了NSF的法定使命，并被认为值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估来支持。