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

这项小企业创新研究（SBIR）第一阶段项目的广泛影响是，通过开发一种可用于评估眼部创伤患者的新型医疗设备，在角膜前损伤的初步评估和分诊方面实现了范式转变。在美国，每年有240万人眼部受伤。最严重的眼部损伤被称为开放性眼球损伤。据报道，成人开放地球仪的发病率为每10万人中2-6例，儿童为每10万人中15.2例。准确的诊断和及时的治疗对视力恢复至关重要。对这些专利做出正确的诊断是非常具有挑战性的，急救人员几乎没有可用的工具。如果怀疑眼球破裂，患者将被转移到三级护理中心，以便有机会获得随叫随到的眼科医生。这种低效的多转诊方法对我们的卫生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660万美元用于治疗开放性损伤。一个可靠、准确、手持式的生物传感器系统可以解决这个问题，为非眼科医生提供一个客观的工具来提高诊断，从而开始对眼睛创伤进行适当的管理，从而挽救视力。该项目将在眼部损伤评估中验证这种生物传感器。在急诊科就诊的眼外伤中，6.8-14.7%是由眼前损伤引起的。这种生物传感器采用了一种复杂的基于纳米技术的方法，通过在传感纸内装载酶的镀金电极，可以将其插入眼睛创伤患者的眼泪膜中，以立即获得损伤程度的结果。本研究的范围是通过优化传感器的基材，最大限度地提高生物传感器试纸的灵敏度。该系统的当前配置是沉积在纸上，团队将转向玻璃或二氧化硅作为基础层，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体积流体检测中的作用，以优化再现性。测试将在收集的眼液样本上进行。从他们的初步工作来看，该团队预计将获得灵敏度超过90%的准确结果。该装置的影响是在角膜前损伤的初步评估和分类的范式转变。这可以防止不必要的高级专科会诊，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.