Humidifeye Plug for Dry Eye Disease

用于干眼病的湿眼塞

• 批准号: 10604903
• 负责人: Niki Bayat
• 金额: $ 25.05万
• 依托单位: AESCULATECH, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10604903
• 关键词: Adhesions; Adoption; Adverse event; Aging; American; Anatomy; Application procedure; Back; Behavior; Biocompatible Materials; Biological; Biomedical Engineering; COVID-19 pandemic; Chemicals; Clinic; Clinical; Clinical Research; Corneal Diseases; Cyclosporine; Data; Development; Device Safety; Devices; Diagnosis; Disincentive; Drops; Dry Eye Syndromes; Duct (organ) structure; Dwarfism; Economic Burden; Economics; Engineering; Environment; Excision; Exhibits; Family; Financial Hardship; Foreign Bodies; Formulation; Gel; Healthcare Systems; Human; Hydrogels; In Vitro; Injections; Irrigation; Life; Liquid substance; Literature; Lubricants; Marketing; Mechanics; Medical; Medical emergency; Methods; Modality; Modeling; Molds; Molecular Structure; N-isopropylacrylamide; Outcome; Patient-Focused Outcomes; Patients; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Phase Transition; Polymers; Positioning Attribute; Price; Procedures; Productivity; Property; Protocols documentation; Radiation; Recommendation; Recovery; Research; Resistance; Rheology; Risk Assessment; Safety; Site; Solid; Strategic Planning; Structure-Activity Relationship; Symptoms; Temperature; Testing; Thinness; Time; Toxic effect; Toxicology; aging population; biomaterial compatibility; bodily sensation; burden of illness; commercialization; common treatment; copolymer; cost; crosslink; design; economic impact; experience; eye dryness; improved; improved outcome; in vivo; innovation; invention; manufacture; member; monomer; multidisciplinary; nanocomposite; novel; prototype; reduce symptoms; response; sealant; systemic toxicity; tv watching; usability; veterinary science

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.

项目摘要 超过1600万美国人被诊断出患有干眼病（DED）。这 由于屏幕时间增加和人口老龄化等因素加重，数量正在增长。 它已经对美国医疗保健系统和700亿美元产生了65.8亿美元的影响 由于生产率下降而导致的总体经济影响。这两个负担的两个因素 价格是现有治疗的不足。常见治疗包括药物 液滴，润滑剂滴和点状插头。总的来说，这些疗法受到穷人的困扰 合规性，效力不佳，不适和失去的成本。药物滴（即 环孢菌素）也可能需要几个月才能实现效果。点状塞提供快速症状缓解 但容易大小的问题，患者不适，在某些情况下需要手术 移动。它们以大致相同的设计和与AT相同的材料制成 他们四十年前的发明。 我们的目的是使用环境开发具有患者适应的点状插头 敏感水凝胶表现出反向相变。大量文学，包括 我们团队成员的事先学术研究说明了n-的理想特性 用于生物医学应用的异丙基丙烯酰胺共聚物。这些申请中的大多数 针对释放药物，迄今为止，没有人设计适合长期的材料 医疗插件。耐用性，可靠的长期过渡行为以及可扩展的制造和 处理都是发展的功能障碍。 Aesculatech团队发展了早期 这种材料和原型涂抹器的模型，可以存储两个月。什么时候 插入后，插头以液体作为液体流入管道，在凝固之前向患者解剖结构成型。 按照标准的灌溉程序，该材料将其恢复为可流动的凝胶以除去。短的 术语早期数据还显示了初步的生物相容性。作为一种新的医疗材料，此插头 需要优化和可靠的行为才能进行商业竞争性的长期使用。如果这个项目 成功，它将提供有关新反应性水凝胶的大量信息，并产生 插头可以改善结果，并为大多数患者提供更安全，更容易的替代方法。 第1阶段将使用流变学和模拟用途研究新的智能水凝胶，以识别 商业上合适的材料。涂抹器还将针对可用的保质期进行优化。 第2-1阶段将使用基于提取物的化学和生物安全进行严格测试 并直接接触方法以及生成禁忌产品列表。 第2-2阶段将在临床上验证产品的性能。