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）：人工耳蜗生理和分子生物学方面的最新发展为治疗和预防感官听力损失的新的和创新的方法铺平了道路。这些进步最终将使数百万个人受益。但是，为此，有必要开发一种安全可靠的机制，将生物活性化合物直接传递到内耳。这项协作研究工作的目的是设计和开发一种用于治疗内耳疾病的多功能长期药物输送系统。从Draper实验室的生物医学工程师共同努力，具有在药物输送微型系统开发方面的经验和专业知识，以及来自马萨诸塞州的眼睛和耳朵医务人员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，将工程，评估和完美的药物输送系统，以治疗内耳耳朵分离的药物。该设备将具有广泛的应用，并具有彻底改变听力损失治疗的潜力。设计概念包括适合人类乳突腔的植入设备。该设备包含一个外部编程的泵，以循环围绕Perilymph，一个通过耳蜗造口术插入了Scala Tympani，这是一个可插入Scala Tympani，这是一个混合室，具有外部可编程的浓缩生物活性化合物的混合室，以及用于检测和传输流动和压力和压力信息的传感器。该系统的核心源自Draper团队在过去几年中设计，制造和测试的新型药物分配微系统。超级初步的设备是一个完整的，长期的（一年及更高）的输送系统，其中包含治疗化合物，分配机制，控制电子和电源。该提案的目的是（1）与内耳建立一个界面，适合于慢性，连续再循环并输注化合物对PerilyMph； （2）开发一个集成的微机械，流体控制系统； （3）建立手术程序并确定乳突腔中植入的装置形式限制； （4）开发适合各种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，遥测和指定电源； （6）使用原型设备来评估初步动物实验中的安全性和功效。