SBIR Phase I: Novel, point-of-service device for use in diagnosing the severity of anterior eye injures with an objective measure of the ocular tear film

该小型企业创新研究（SBIR）第一阶段项目的更广泛影响是通过开发可用于评估眼外伤患者的新医疗器械，实现了前角膜损伤初始评估和分诊的范式转变。美国每年有240万眼外伤。最严重的眼部损伤称为开放性地球仪损伤。据报道，开放性眼球的发病率在成人中为每100，000人2-6人，在儿童中为每100，000人15.2人。准确的诊断和及时的治疗是视力恢复的关键。对这些专利做出正确的诊断是非常具有挑战性的，第一反应者几乎没有可用的工具。如果怀疑存在地球仪破裂，则将患者转移到三级护理中心，以便获得待命眼科医生。这种效率低下的多转诊方法对我们的医疗保健系统来说代价高昂，并延误了适当的护理。 美国每年花费660万美元用于开放式球体损伤。使用可靠、准确、手持式的生物传感器系统可以解决这个问题，为非眼科医生提供客观的工具来改善诊断，以便对眼外伤进行适当的管理，从而挽救视力。拟议的项目将验证这种生物传感器在眼睛损伤的评估。6.8%-14.7%的眼外伤是由前部损伤引起的。这种生物传感器使用一种复杂的基于纳米技术的方法，通过传感纸内的酶负载镀金电极，可以插入眼外伤患者的眼泪膜中，以获得关于损伤程度的即时结果。本研究的范围是通过优化传感器的基底材料来最大限度地提高生物传感器测试条的灵敏度。拟议系统的当前配置是沉积在纸上，该团队将转向玻璃或二氧化硅作为基层，以提高设备的灵敏度。接下来，该团队将研究可变聚合物涂层及其在小流体体积稳健检测中的作用，以优化再现性。将对采集的眼内液样本进行检测。从他们的初步工作，该团队预计实现准确的结果，灵敏度超过90%。该设备的影响是前角膜损伤的初始评估和分类的范式转变。这避免了不必要的高水平专业咨询，并利用技术进步以更低的成本提供更好的护理。

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is a paradigm shift in the initial evaluation and triage of anterior corneal injuries, through the development of a new medical device that can be used to evaluate a patient with an eye trauma. There are 2.4 million eye injuries per year in the United States. The most serious eye injury is called an open globe injury. The incidence of open globes has been reported to be between 2-6 per 100,000 in adults and 15.2 per 100,000 in children. Accurate diagnosis and timely management are critical for visual recovery. Making the correct diagnosis on these patents is very challenging and first responders have very little tools available to them. If suspicion for ruptured globe exists, the patients are transferred to a tertiary care center in order to have access to an on-call eye doctor. This inefficient, multi-referral approach is very costly to our health care system and delays proper care. The United States spends $6.6 million dollars each year on open globes injuries. Access to a reliable, accurate, hand-held, biosensor system can solve this problem by providing non-ophthalmologists with a objective tool to improve diagnosis in order to initiate the proper management for eye traumas which could save vision. The proposed project will validate this biosensor in the evaluation of eye injuries. 6.8-14.7% of ocular traumas that present to the emergency department are from anterior injuries. This biosensor uses a sophisticated nanotechnology-based approach through an enzyme-loaded gold plated electrode within sensing paper that can be inserted in the ocular tear film of patients with eye trauma to obtain immediate results on the degree of injury. The scope of this study is to maximize the sensitivity of the biosensor test strips by optimizing the base material of the sensor. The current configuration of the proposed system is deposited on paper, and the team will move to glass or silica as a base layer to improve the sensitivity of the device. Next, the team will study the variable polymer coatings and their effect in robust detection of small fluid volumes to optimize reproducibility. Testing will be on samples of collected ocular fluid. From their preliminary work, the team anticipates achieving accurate results with sensitivity of greater than 90%. The impact of this device is a paradigm shift in the initial evaluation and triage of anterior corneal injuries. This prevents unnecessary high-level specialty consultation and uses technology advancements to provide better care with lower cost approaches.