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Liquid-infused tympanostomy tubes with novel material design for efficient drug transport

采用新颖材料设计的液体灌注鼓膜造口管可实现高效药物运输

基本信息

批准号：
10324862
负责人：
Ida Pavlichenko
金额：
$ 34.95万
依托单位：
PIONEAR TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-07-08 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10324862
关键词：
Acute Adhesions Affect Age Antibiotics Applied Research Award Bacteria Biological Markers Biomedical Engineering Blood Cells Chemicals Child Chinchilla (genus)Chronic Ciprofloxacin Clinical Collaborations Contracts Dexamethasone Direct Costs Disease Dose Drainage procedure Drops Drug Delivery Systems Drug Transport Ear Economic Burden Engineering Eye Facilities and Administrative Costs Fibroblasts Frequencies Future Geometry Goals Gold Health Care Visit Image Implant In Vitro Infection Inflammation Inflammatory Institutes Legal patent Liquid substance Massachusetts Measurement Medical Medical Device Microbial Biofilms Modeling Morphology Mucins Nontypable Haemophilus influenza Operative Surgical Procedures Otitis Media Otitis Media with Effusion Otolaryngologist Otorrhea Penetration Performance Persons Pharmaceutical Preparations Phase Prize Pump Pus Recurrence Regimen Research Resistance Resolution Schools Small Business Innovation Research Grant Stains Suspensions Techniques Technology Testing Therapeutic Topical Antibiotic Topical application Tube Tympanic membrane Tympanostomy Tympanostomy Tube Insertions Update Water Work biomaterial compatibility college combat commercialization design ear infection efficacy validation experimental study flexibility implantation improved in vivo innovation keratinocyte liquid chromatography mass spectrometry middle ear middle ear fluid millimeter minimally invasive novel pathogen pathogenic bacteria pre-clinical preservation pressure prevent programs standard care stem symposium translational medicine ventilation

项目摘要

Project Summary Otitis media (OM) is the leading cause of healthcare visits in the world, affecting more than 700 million people worldwide1 and accruing a significant economic burden of over $5 billion annually in direct and indirect costs in the US alone2. Children are particularly susceptible to this disease; 90% of children will contract OM by the age of five3,4, with 40% of cases eventually becoming recurrent or chronic5. The gold standard for treatment of recurrent acute OM and chronic OM with effusion is myringotomy surgery with tympanostomy tube insertion, in which a small tube is inserted into the tympanic membrane to ventilate and drain fluids out of the middle ear. Nearly 700,000 children in the US are treated with tympanostomy tubes (TTs) annually. To help resolve infection and prevent otorrhea, tube insertion is commonly supplemented with a regimen of topical antibiotics. However, due to their lumen geometry and material composition, existing TTs are not optimized for reliable delivery of drugs into the middle ear and frequently become occluded by cellular debris, pathogenic bacteria, blood, and pus. Such challenges hinder OM treatment and prompt invasive TT replacement surgeries in up to 20% of children with TTs.6 To combat these challenges simultaneously, PionEar Technologies Inc. is developing tympanostomy tubes (PionEar TTs) with a patent-pending material design that synergistically reduces the pressure barrier for drugs to penetrate into the middle ear and suppresses bioadhesion, thus maximizing the therapeutic benefit of topical drugs and facilitating earlier eradication of infection. Novel bio-inspired PionEar TTs possess (1) precisely engineered lumen geometry that is optimized to promote spontaneous transport of therapeutics even without tragal pumping, and (2) slippery liquid-infused materials that further minimize contact line pinning while suppressing bioadhesion7–9. PionEar tubes are biocompatible and non-ototoxic, minimally invasive, and simple-to-manufacture. They preserve critical functionality of existing tympanostomy tubes: to enable ventilation and drainage of the middle ear and prevent water from entering the middle ear.10,11 In an SBIR Phase I, we propose to assess the in vivo performance of PionEar tubes for promoting more efficient drug delivery and resolution of OM compared to commercial tubes in a gold-standard OM chinchilla model. Demonstration of proof-of-concept will prepare the technology for successful Phase II application and future commercialization. If successful, PionEar TTs would alleviate the prevalent issue of recurrent ear infections and complications, and open up new avenues for the treatment of OM. PionEar Technologies Inc. was born out of three years of rigorous translational medicine research and collaboration between Harvard’s Wyss Institute, J.A. Paulson School of Engineering and Applied Sciences, and Massachusetts Eye and Ear. Its novel TT technology was awarded the Grand Prize at the Collegiate Inventors Competition by NIHF and USPTO as well as five other prestigious awards.

项目摘要中耳炎（OM）是世界上医疗保健就诊的主要原因，影响超过7亿人 1，每年直接和间接造成超过50亿美元的重大经济负担。仅在美国的成本2。儿童特别容易患上这种疾病; 90%的儿童会感染OM， 5岁3，4，40%的病例最终成为复发或慢性5。治疗的黄金标准复发性急性OM和慢性OM伴积液的最佳治疗方法是鼓膜切开术加鼓膜置管，其中将小管插入鼓膜中以将液体排出中耳。在美国，每年有近70万儿童接受鼓膜造口管（TT）治疗。帮助解决为了防止感染和防止耳鼻喉，插管通常辅以局部抗生素方案。然而，由于它们的管腔几何形状和材料组成，现有的TT并没有针对以下方面进行优化：可靠地将药物输送到中耳中并经常被细胞碎片堵塞，病原菌血液和脓液这些挑战阻碍了OM治疗并促使侵入性TT 多达20%的TT儿童接受了替代手术。6 为了同时应对这些挑战，PionEar Technologies Inc.正在开发鼓膜造口管（PionEar TT）采用正在申请专利的材料设计，药物渗透到中耳的压力屏障，并抑制生物粘附，使局部药物的治疗益处最大化并促进感染的早期根除。小说生物启发的PionEar TT具有（1）精确设计的管腔几何形状，即使没有耳屏泵送，治疗剂也能自发输送，以及（2）光滑的液体注入材料这进一步使接触线钉扎最小化，同时抑制生物粘附7 -9。PionEar管具有生物相容性并且无耳毒性、微创且易于制造。它们保留了现有的鼓膜造口管：使中耳通气和引流，并防止水进入在SBIR第一阶段，我们建议评估PionEar管的体内性能，与黄金标准中的商业管相比，促进更有效的药物递送和OM的分辨率 OM栗鼠模型。概念验证的演示将为成功的第二阶段做好技术准备应用和未来商业化。如果成功，PionEar TT将缓解普遍存在的问题，复发性耳部感染和并发症，并为OM的治疗开辟了新的途径。 PionEar技术公司诞生于三年严格的转化医学研究，哈佛大学的韦克斯曼研究所和J.A.保尔森工程与应用科学学院，以及马萨诸塞州眼耳。其新颖的TT技术获得了大学发明家大奖由NIHF和USPTO以及其他五个著名奖项的竞争。