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.

这项小型企业创新研究阶段I项目提议展示和开发微创药物输送技术的原型，以满足对更实用和有效的倍跨药物输送系统的需求。该技术将专有的Trocar导管与基于MEMS的微流体系统相结合，用于控制，持续的前庭或耳蜗激活药物进入中耳中的中耳，以吸收内耳，以吸收常见的听力和前庭疾病，用于用于耳鼻喉科学，基于办公的基于办公室的设置。该阶段I项目将利用初步研究，包括先前具有人类暂时骨骼的导管研究，以及针对剂量和微型倾斜的研究，以设计和开发面包板原型，用于控制的，跨脑剂的交付，其中包括：（a）插入技术和循环系统，用于改进的药物灌注以及（b）一项小型技术，以及（b）提供最佳药品。将评估使用塑料耳和颞骨核的医师测试仪的可行性。预计该项目的更广泛的影响/商业潜力将更有效地治疗常见的内耳疾病，例如脑膜病，慢性迷宫炎，突然的感官性听力损失和可治不性的耳鸣，影响了全球数百万的人。 Meniere疾病影响了全世界约12个人，据估计，美国有790万人患有耳鸣。尽管通常了解了倍跨交付的优势，但控制仍然是实现最佳和一致的结果的主要挑战。结局的范围内，甚至是受试者的变异性，引入了当前实践的一个主要问题，引入了严重的副作用的潜力，例如OTO毒性，可能导致永久性听力损失和前庭性障碍和功能障碍。最近的研究表明，这些缺点可以在很大程度上以精确，控制，持续的，低浓度的递送到圆形窗户膜。尽管正在进行研究以开发用于手术植入的受控或被动时间释放传递产品的产品，但推进非手术，侵入性较小且更具积极控制的交付具有显着价值。预计该技术将克服市场和开发技术的疗效和实际缺陷。