Humidifeye Plug for Dry Eye Disease

项目摘要 1600多万美国人被诊断出患有干眼症(DED)。这 由于屏幕时间增加和人口老龄化等加剧因素，这一数字正在增长。 据估计，它对美国医疗体系的影响为65.8亿美元，对美国医疗体系的影响为700亿美元 由于生产率下降而造成的整体经济影响。造成这一负担的两个因素 这一价格是现有治疗方法的不足吗？常见的治疗方法包括药物 滴液、润滑剂滴液和点状插头。总体而言，这些疗法都受到穷人的困扰 依从性、疗效差、不适感和难以为继的费用。药物滴剂(即 环孢素)也可能需要几个月的时间才能达到效果。点状插头可迅速缓解症状 但容易出现尺寸问题、患者不适，在某些情况下需要手术 移走。它们的设计和材质与 他们四十多年前的发明。 我们的目标是开发一种患者可适应的点状插头，使用环境 具有反向相变的敏感水凝胶。丰富的文学作品，包括 我们团队成员先前的学术研究表明了N-的可取性质 生物医用异丙基丙烯酰胺共聚物。这些应用中的大多数 是以药物释放为目标的，到目前为止还没有人设计出一种适合长期使用的材料 医疗插入物。耐用性、可靠的长期过渡行为和可扩展的制造和 加工都是发展的功能性障碍。AesculaTech团队开发了一种早期的 这种材料的模型和一个可以储存两个月的涂抹器原型。什么时候 插入后，塞子以液体的形式流入导管，在固化之前对患者的解剖结构进行成型。 在标准的灌溉过程中，这种物质会恢复成可流动的凝胶进行去除。短的 期初数据也显示出初步的生物相容性。作为一种新的医用材料，这个塞子 需要优化和可靠的行为才能长期使用具有商业竞争力的产品。如果这个项目 如果成功，它将提供关于新的响应性水凝胶的丰富信息，并产生 Plug可改善结果，并为大多数患者提供更安全、更容易的替代方案。 第一阶段将研究新的智能水凝胶，使用流变学和模拟用途来识别 商业上合适的材料。Applicator还将针对可用货架寿命进行优化。 阶段2-1将严格测试设备的化学和生物安全性，使用基于萃取物的 以及直接接触方法以及生成违禁产品清单。 阶段2-2将在临床上验证该产品的性能。

Project Summary More than 16 million Americans have been diagnosed with Dry Eye Disease (DED). This number is growing due to aggravating factors like increased screen time, and an aging population. It already has an estimated impact of $6.58 billion on the US healthcare system and $70 billion overall economic impact due to decrease in productivity. Two contributing factors to this burden are the price an inadequacy of existing treatments. Common treatments include pharmaceutical drops, lubricant drops, and punctal plugs. Collectively, these therapies are plagued by poor compliance, poor efficacy, discomfort, and untenable costs. Pharmaceutical drops (i.e. Cyclosporine) can also take months to achieve an effect. Punctal plugs offer rapid symptom relief but are prone to sizing issues, patient discomfort, and in some cases the need for surgical removal. They are made in approximately the same designs and with the same materials as at their invention over forty years ago. Our objective is to develop a patient-adaptable punctal plug using environmentally sensitive hydrogels which exhibit a reverse phase transition. An abundance of literature, including prior academic research by members of our team, illustrates the desirable properties of N- isopropylacrylamide copolymers for biomedical applications. The majority of these applications are aimed at drug release, and to-date no one has designed a material suitable for a long-term medical insert. Durability, reliable long-term transition behavior, and scalable manufacture and processing are all functional barriers to development. The AesculaTech team developed an early model of such a material and a prototype applicator which can store it for two months. When inserted, the plug flows into the duct as a liquid, molding to patient anatomy before solidifying. Upon a standard irrigation procedure, this material reverts back to flowable gel for removal. Short term early data has also shown preliminary biocompatibility. As a new medical material, this plug requires optimized and reliable behavior for commercially competitive long-term use. If this project is successful, it will provide a wealth of information on new responsive hydrogels and produce a plug which improves outcomes and provides a safer and easier alternative for most patients. Phase 1 will research new smart hydrogels, using rheology and simulated use to identify a commercially suitable material. The Applicator will also be optimized for usable shelf-life. Phase 2-1 will rigorously test the chemical and biological safety of the device using extract-based and direct contact methods along with generating a list of contraindicated products. Phase 2-2 will clinically validate the performance of the product.