Novel Inner Ear Drug Delivery System

新型内耳药物输送系统

• 批准号: 6549763
• 负责人: Tomasz J Petelenz
• 金额: $ 10.06万
• 依托单位: STERLING RESEARCH CORPORATION
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6549763
• 关键词: Meniere's disease; bioengineering /biomedical engineering; biomedical equipment development; cochlear implants; drug delivery systems; ear disorder chemotherapy; implant; injection /infusion; labyrinth; labyrinth disorder; telemetry

DESCRIPTION (provided by applicant): Sarcos Research Corporation proposes a novel microinfusion system for administration of medications for treatment of middle ear and cochlear diseases, such as sudden hearing loss, Menieres disease, instances of tinnitus, and for providing pharmacological hearing protection in chemotherapy. Methods that are currently in use cause systemic toxicity, do not provide suffient dose control (injections, wicks) or are impractical (waist-mounted pumps) and expensive. The proposed system will be small size, light-weight, will fit safely and comfortably behind the patient's ear, and will deliver medications into the middle ear in precise, controlled programmable and convenient manner, increasing effectiveness, reducing side effects and improving compliance with the therapy. In the future, the system will evove into totally implantable unit for treatment of chronic and/or recurrent conditions. In addition to improving the existing treatment regimens, the system will enable application of chronotherapy and other temporal dose patterns to increase effectiveness and reduce side effects, and will allow administration of medications in the head-and-neck area for treament of cancer in both hospital and at-home settings. For this application, Sarcos will adapt its microinfusion pump and microcatheter technologies to create a system that will consist of a micropump, a programmer with a wireless data link, and a drug delivery catheter. Due to the significant advancement of the already developed technology base that is available at Sarcos for this project, and in order to accelerate the development of the commercial product, Sarcos proposes a joint Phase I/Il (Fast Track) effort that will result in a validated system ready for commercialization and clinical implementation. Phase I of this project will result in a definitive feasibiility prototype, wherease the projected Phase II will end with a commercial product and completed regulatory submission to the FDA. The proposed system will have significant health and economic impact as it it is estimated that more than 28 millions Americans suffer from preventable hearing loss, at least 3 million are affected by Menieres disease, and 40 to 45 million have life-impairing tinnitus, resulting in an estimated cost of lost productivity that exceeds 30 billion dollars per year.

描述（由申请人提供）：Sarcos Research Corporation提出了一种新型的微型灌注系统，用于治疗中耳和耳蜗疾病的药物治疗，例如突然的听力损失，Menieres疾病，耳鸣实例，以及在化学疗法中提供药理听力保护。当前使用的方法会导致全身毒性，不提供足够的剂量控制（注射，灯芯）或不切实际（腰部泵）且昂贵。拟议的系统将是小尺寸，轻量重量，将安全，舒适地贴合患者的耳朵后面，并以精确，可控制的可编程和方便的方式将药物运送到中耳中，增强有效性，降低副作用并改善对治疗的遵守。将来，该系统将发现完全可植入的单元，以治疗慢性和/或经常性疾病。除了改善现有的治疗方案外，该系统还将实现年代疗法和其他时间剂量模式的应用，以提高有效性并降低副作用，并允许在头颈区域进行药物治疗，以在医院和家庭环境中进行癌症治疗。 对于此应用，Sarcos将适应其微型灌注泵和微导管技术，以创建一个系统，该系统由微型泵组成，具有无线数据链路的程序员和药物输送导管。由于该项目的Sarcos可以使用的已经开发的技术基础的显着进步，并为了加速商业产品的开发，Sarcos提出了联合阶段I/IL（快速轨道）工作，该努力将导致验证的已验证的系统，准备进行商业化和临床实施。该项目的第一阶段将导致确定的可行性原型，在此期间，预计的II期将以商业产品结束，并完成对FDA的监管提交。 拟议的系统将对健康和经济影响产生重大的影响，因为据估计，超过2800万美国人的听力损失，至少300万受梅尼耶雷斯病的影响，而40至4500万的人的耳鸣造成了损失，估计损失的生产力成本超过每年300亿美元。