I-Corps: A New Delivery Technology for Treating Chronic Eustachian Tube Dysfunction and Otitis Media with Effusion

I-Corps：一种治疗慢性咽鼓管功能障碍和渗出性中耳炎的新型输送技术

• 批准号: 2219880
• 负责人: Khaled Sallam
• 金额: $ 5万
• 依托单位: Oklahoma State University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2023-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2219880&HistoricalAwards=false
• 关键词: Corps; New; Delivery; Technology; Treating

The broader impact/commercial potential of this I-Corps project is the development of minimal-invasive, cost effective, and reliable way of treating eustachian tube dysfunction (ETD) and otitis media with effusion (OME). OME is one of the leading causes of medical consultations and the most frequent reason for antibiotic prescription and surgery in children resulting in over $5 billion annual expenditures in the United States. In the US, each year nearly 700,000 children have tympanostomy tubes inserted because of chronic middle ear fluid and frequent ear infections. Treatment-resistant children with ETD/OME are affected by conductive hearing loss, language development issues, poor school performance, and are much more likely to have chronic middle ear problems in adulthood. The problem is equally concerning for many adults who continue to suffer from ETD despite available surgical treatments. ETD/OME is one of the main reasons for office visits in the USA and is estimated to affect 11 million US adults. Patients with chronic ETD (which occurs in ~11% of all ETD cases in the US) get frustrated and anxious about recurring visits for ETD/OME issues, while clinicians cannot provide effective care for these patients and insurance companies incur losses by reimbursing surgical procedures with limited efficacy.This I-Corps project is based on the development of a technology for the treatment of the underlying causes of chronic eustachian tube dysfunction (ETD) and persistent effusions. Recognizing existing treatment limitations, the proposed technology is a non-invasive device for targeted delivery of medications into the eustachian tube (ET) pharyngeal opening. The proposed approach has the potential to enhance outcomes for chronic ETD/otitis media with effusion (OME) patients from combining therapeutic action of formulations delivered into the ET (e.g., in reducing mucosal inflammation, hypersecretion, adhesion), and airflow and air pressure-assisted opening and insufflation of the ET. The hypothesis is that the approach may enhance particle deposition in the posterior region of the nasal cavity and enable formulation delivery to the ET orifice and lumen. Local delivery into the ET potentially may be an efficient approach for treating underlying causes (e.g., mucosal inflammation) that contribute to chronic ETD and persistent effusions while minimizing systemic side effects. The proposed technology has the potential to become a new treatment for chronic ETD/OME.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 I-Corps 项目更广泛的影响/商业潜力是开发微创、具有成本效益且可靠的治疗咽鼓管功能障碍 (ETD) 和渗出性中耳炎 (OME) 的方法。 OME 是儿童医疗咨询的主要原因之一，也是儿童抗生素处方和手术的最常见原因，导致美国每年花费超过 50 亿美元。在美国，每年有近 700,000 名儿童因慢性中耳积液和频繁的耳部感染而被插入鼓膜造口管。患有 ETD/OME 的难治性儿童会受到传导性听力损失、语言发展问题、学习成绩差的影响，并且在成年后更有可能患有慢性中耳问题。对于许多尽管进行了手术治疗但仍继续患有 ETD 的成年人来说，这个问题同样令人担忧。 ETD/OME 是到美国办公室就诊的主要原因之一，估计影响 1100 万美国成年人。患有慢性 ETD 的患者（约占美国所有 ETD 病例的 11%）对因 ETD/OME 问题而反复就诊感到沮丧和焦虑，而临床医生无法为这些患者提供有效的护理，保险公司也因效果有限的外科手术报销而蒙受损失。该 I-Corps 项目基于开发一种治疗慢性咽鼓管功能障碍根本原因的技术 (ETD) 和持续性积液。认识到现有治疗的局限性，所提出的技术是一种非侵入性装置，用于将药物有针对性地输送到咽鼓管（ET）咽部开口中。所提出的方法有可能通过结合递送到 ET 中的制剂的治疗作用（例如，减少粘膜炎症、分泌过多、粘连）以及气流和气压辅助 ET 的打开和吹气，来增强慢性 ETD/渗出性中耳炎 (OME) 患者的治疗效果。假设该方法可以增强鼻腔后部区域的颗粒沉积，并使制剂能够输送到 ET 孔口和管腔。局部递送至 ET 可能是治疗导致慢性 ETD 和持续性积液的根本原因（例如粘膜炎症）的有效方法，同时最大限度地减少全身副作用。拟议的技术有潜力成为慢性 ETD/OME 的新疗法。该奖项反映了 NSF 的法定使命，并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，被认为值得支持。