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 研究公司提出了一种新型微输注系统，用于给药治疗中耳和耳蜗疾病，例如突发性听力损失、梅尼埃病、耳鸣，并在化疗中提供药理学听力保护。目前使用的方法会导致全身毒性，不能提供足够的剂量控制（注射、吸芯）或不切实际（腰部安装泵）且昂贵。所提出的系统体积小、重量轻，将安全舒适地安装在患者耳后，并以精确、受控、可编程和方便的方式将药物输送到中耳，从而提高有效性、减少副作用并提高依从性。治疗。未来，该系统将演变成完全植入式装置，用于治疗慢性和/或复发性疾病。除了改进现有的治疗方案外，该系统还将支持时间疗法和其他时间剂量模式的应用，以提高疗效并减少副作用，并将允许在两家医院的头颈部区域进行癌症治疗药物治疗和家庭设置。 对于此应用，Sarcos 将采用其微输液泵和微导管技术来创建一个系统，该系统由微泵、带有无线数据链路的编程器和药物输送导管组成。由于 Sarcos 可用于该项目的已开发技术基础的显着进步，并且为了加速商业产品的开发，Sarcos 提出了联合阶段 I/II（快速通道）工作，这将导致经过验证的系统已准备好商业化和临床实施。该项目的第一阶段将产生一个明确的可行性原型，而预计的第二阶段将最终推出商业产品并完成向 FDA 的监管提交。 拟议的系统将产生重大的健康和经济影响，因为据估计，超过 2800 万美国人患有可预防的听力损失，至少 300 万人受到梅尼埃病的影响，40 至 4500 万人患有危及生命的耳鸣，从而导致据估计，每年生产力损失造成的损失超过 300 亿美元。