Micromechanical Device for Intracochlear Drug Delivery

用于耳蜗内药物输送的微机械装置

• 批准号: 7010469
• 负责人: Jeffrey T. Borenstein
• 金额: $ 86.23万
• 依托单位: CHARLES STARK DRAPER LABORATORY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-15 至 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7010469
• 关键词: action potentials; bioengineering /biomedical engineering; biomaterial compatibility; biomedical device power system; biomedical equipment development; cochlea; drug delivery systems; ear disorder chemotherapy; guinea pigs; human tissue; implant; labyrinth disorder; medical implant science; microfluidics; miniature biomedical equipment; otoacoustic emission; perfusion; perilymph; postmortem; sensorineural hearing loss; telemetry; temporal bone

DESCRIPTION (provided by applicant): Recent developments in cochlear physiology and molecular biology have paved the way for new and innovative ways of treating and preventing sensorineural hearing loss. These advances will ultimately benefit millions of individuals. However, for this to occur, it will be necessary to develop a safe and reliable mechanism for delivering bioactive compounds directly to the inner ear. The goal of this collaborative research effort is to design and develop a versatile long-term drug delivery system for the treatment of inner ear disorders. Working together, biomedical engineers from Draper Laboratory with experience and expertise in the development of drug delivery microsystems, and clinicians and scientists from the Massachusetts Eye and Ear Infirmary with expertise in inner ear physiology, pharmacology and otologic surgery will engineer, evaluate and perfect a drug delivery system for the treatment of inner ear disorders. This device will have broad application and the potential for revolutionizing the treatment of hearing loss. The design concept includes an implanted device that fits within the mastoid cavity of humans. The device contains an externally-programmable pump to recirculate perilymph, an intracochlear catheter inserted into the scala tympani through a cochleostomy, a mixing chamber with externally programmable delivery of concentrated bioactive compounds, and sensors for detecting and transmitting flow and pressure information. The core of the system is derived from a novel drug dispensing microsystem that the Draper team has designed, fabricated, and tested over the past several years. The ultra-miniaturized device is a complete, longterm (one year and greater) delivery system, containing therapeutic compound, dispensing mechanism, control electronics, and power supply. The aims of the proposal are to (1) develop an interface to the inner ear suitable for chronic, continuous recirculation of and infusion of compounds into perilymph; (2) develop an integrated, micromachined, fluid control system; (3) establish surgical procedures and determine device form factor constraints for implantation in the mastoid cavity; (4) develop an implantable drug storage reservoir, filling, and release mechanism appropriate for a range of candidate therapies; (5) develop low power control electronics, telemetry, and specify power source; and (6) evaluate safety and efficacy in preliminary animal experiments, using prototype devices to deliver compounds to the inner ear.

描述（由申请人提供）：耳蜗生理学和分子生物学的最新发展为治疗和预防感音神经性听力损失的新方法铺平了道路。这些进步最终将使数百万人受益。然而，为了实现这一点，有必要开发一种安全可靠的机制，将生物活性化合物直接输送到内耳。这项合作研究的目标是设计和开发一种多功能的长期药物输送系统，用于治疗内耳疾病。来自德雷珀实验室的生物医学工程师在药物输送微系统开发方面具有经验和专业知识，来自马萨诸塞州眼耳医院的临床医生和科学家在内耳生理学，药理学和耳科手术方面具有专业知识，他们将共同设计，评估和完善用于治疗内耳疾病的药物输送系统。该设备将具有广泛的应用和彻底改变听力损失治疗的潜力。该设计概念包括一种植入式器械，可植入人体乳突腔。该装置包含一个外部可编程泵，以再循环外淋巴液，一个耳蜗内导管插入鼓阶通过耳蜗造口术，一个混合室与外部可编程输送浓缩的生物活性化合物，和传感器，用于检测和传输流量和压力信息。该系统的核心来自一种新型的药物分配微系统，该系统是德雷珀团队在过去几年中设计、制造和测试的。超小型化装置是一个完整的长期（一年或更长时间）输送系统，包含治疗化合物、分配机制、控制电子设备和电源。该提案的目的是（1）开发一种适合于化合物慢性、连续再循环和输注到外淋巴中的内耳接口;（2）开发一种集成的、微机械加工的流体控制系统;（3）建立外科手术程序并确定植入乳突腔中的装置形状因子限制;（4）开发适合于一系列候选疗法的可植入药物储存库、填充和释放机制;（5）开发低功率控制电子器件、遥测技术和指定电源;和（6）在初步动物实验中使用原型装置将化合物递送至内耳，评价安全性和有效性。