SBIR Phase I: Actively-Controlled Transtympanic (ACT) Drug Delivery System

SBIR 第一阶段：主动控制经鼓室 (ACT) 给药系统

• 批准号: 1315779
• 负责人: Reza Shekarriz
• 金额: $ 15万
• 依托单位: Yainax Medical, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-01 至 2013-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1315779&HistoricalAwards=false
• 关键词: SBIR; Phase; Actively; Controlled; Transtympanic

This Small Business Innovation Research Phase I project proposes to demonstrate and develop a prototype of a minimally-invasive drug delivery technology to address the need for a more practical and effective transtympanic drug delivery system. The technology combines a proprietary trocar catheter with a MEMS-based microfluidic system for controlled, sustained delivery of vestibulo-active or cochleo-active drugs into the middle ear for absorption to the inner ear, for common hearing and vestibular disorders for applications in the otolaryngology, office-based setting. This Phase I project will utilize preliminary research, including prior catheter studies with human temporal bones, as well as research around dosing and micropumping to design and develop a breadboard prototype for controlled, transtympanic delivery that includes: (a) insertion technology and circulating system for improved drug perfusion, and (b) a microfluidics technology to deliver drugs with the optimal protocol. The feasibility with physician testers using both plastic ears and temporal bone cores will be evaluated. The broader impact/commercial potential of this project is anticipated to be in more effective treatment of common inner ear diseases such as Meniere?s disease, chronic labyrinthitis, sudden sensorineural hearing loss and intractable tinnitus that impact millions of people worldwide. Meniere?s disease affects approximately 12 in 1000 individuals worldwide, and it is estimated that 7.9 million individuals in the U.S. suffer from tinnitus. Although the advantages of transtympanic delivery are generally understood, control remains a major challenge to realizing optimal and consistent outcomes. Wide inter-subject, and even intra-subject, variability in outcomes has presented a major problem with current practice, introducing the potential of serious side effects, such as oto-toxicity, that can lead to permanent hearing loss and vestibular hypofunction, or dysfunction. Recent studies indicate these shortcomings can be largely overcome with precise, controlled, sustained, low concentration delivery to the round window membrane. While research is underway to develop products for surgically-implanted controlled or passive time-release delivery, there is significant value for advancing a non-surgical, less invasive and more actively-controlled delivery. It is expected that this technology will overcome both efficacy and practical shortcomings of the technologies on the market and in development.

这个小型企业创新研究第一阶段项目建议展示和开发一种微创药物输送技术的原型，以满足对更实用和有效的经鼓室药物输送系统的需求。该技术将专利套管针导管与基于MEMS的微流体系统相结合，可控制、持续地将前庭活性或耳蜗活性药物输送到中耳，吸收到内耳，治疗常见的听力和前庭疾病，用于耳鼻咽喉科办公室设置。这个第一阶段的项目将利用初步研究，包括先前对人类颞骨的导管研究，以及有关剂量和微泵的研究，以设计和开发用于受控、经鼓室输送的面包板原型，其中包括：(A)用于改善药物灌流的插入技术和循环系统，以及(B)以最佳方案输送药物的微流体技术。将评估使用塑料耳朵和颞骨核心的医生测试仪的可行性。该项目的更广泛影响/商业潜力预计将是对常见内耳疾病的更有效治疗，如梅尼埃？S病、慢性迷路炎、突发性感音神经性耳聋和影响全球数百万人的顽固性耳鸣。梅尼埃？S病在全世界大约每1000人中就有12人受到影响，据估计，美国有790万人患有耳鸣。虽然人们普遍了解经鼓室分娩的优点，但控制仍然是实现最佳和一致结果的主要挑战。受试者之间，甚至受试者内，结果的广泛差异已经成为当前实践的一个主要问题，这带来了严重副作用的可能性，如耳毒性，可能导致永久性听力损失和前庭功能减退或功能障碍。最近的研究表明，通过精确、可控、持续、低浓度的圆窗膜给药，这些缺点可以在很大程度上得到克服。虽然正在研究开发用于手术植入的受控或被动时间释放递送的产品，但对于推进非手术、侵入性更小和更主动控制的递送具有重大价值。预计这项技术将克服市场上和开发中的技术的有效性和实用缺点。