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

I-Corps项目更广泛的影响和商业潜力是开发一种微创、经济、可靠的方法来治疗咽鼓管功能障碍（ETD）和中耳炎伴积液（OME）。OME是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，导致美国每年支出超过50亿美元。在美国，每年有近70万儿童因为慢性中耳积液和频繁的耳部感染而植入鼓膜造瘘管。患有ETD/OME的治疗抵抗儿童受到传导性听力损失、语言发展问题、学习成绩差的影响，并且更有可能在成年后出现慢性中耳问题。这个问题同样令人担忧的是，尽管有手术治疗，许多成年人仍然患有ETD。在美国，ETD/OME是就诊的主要原因之一，估计有1100万美国成年人受到影响。慢性ETD患者（约占美国所有ETD病例的11%）对因ETD/OME问题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，保险公司因报销效果有限的外科手术而蒙受损失。这个I-Corps项目的基础是开发一种技术，用于治疗慢性咽鼓管功能障碍（ETD）和持续性积液的潜在原因。认识到现有的治疗局限性，提出的技术是一种非侵入性装置，用于将药物靶向递送到咽鼓管（ET）咽口。所提出的方法有可能通过联合给予ET的制剂的治疗作用（例如，减少粘膜炎症、分泌过多、粘连）来提高慢性ETD/积液中耳炎（OME）患者的疗效。以及气流和气压辅助下鼻翼的打开和充气。假设该入路可能会增强鼻腔后部区域的颗粒沉积，并使制剂能够输送到鼻翼孔和腔。局部给药到ET可能是治疗导致慢性ETD和持续积液的潜在原因（如粘膜炎症）的有效方法，同时最大限度地减少全身副作用。提出的技术有可能成为慢性ETD/OME的新治疗方法。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.