Micromechanical Device for Intracochlear Drug Delivery

用于耳蜗内药物输送的微机械装置

• 批准号: 7201598
• 负责人: Jeffrey T. Borenstein
• 金额: $ 84.67万
• 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/7201598
• 关键词: Animal Experiments; Animals; Biomedical Engineering; Catheters; Chronic; Cochlear implant procedure; Condition; Development; Devices; Drug Delivery Systems; Drug Storage; Ear; Electronics; Engineering; Eye; Goals; Human; Individual; Inflammatory; Infusion procedures; Laboratories; Labyrinth; Liquid substance; Massachusetts; Mastoid process; Methodology; Modeling; Molecular Biology; Operative Surgical Procedures; Perilymph; Pharmaceutical Preparations; Pharmacology; Physiology; Power Sources; Principal Investigator; Pump; Range; Research; Safety; Scala Tympani; Scientist; Sensorineural Hearing Loss; Specific qualifier value; System; Technology; Telemetry; Temporal bone structure; Testing; Therapeutic; Work; age related; base; concept; controlled release; design; experience; hearing impairment; implantable device; implantation; inner ear diseases; innovation; microsystems; miniaturize; novel; pressure; prevent; programs; prototype; sensor

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（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，为了实现这一目标，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。德雷珀实验室的生物医学工程师在药物输送微系统的开发方面具有丰富的经验和专业知识，马萨诸塞州眼耳医院的临床医生和科学家在内耳生理学、药理学和耳科外科方面具有专业知识，他们将共同努力，设计、评估和完善治疗内耳疾病的药物输送系统。该装置将有广泛的应用，并有可能彻底改变听力损失的治疗。设计概念包括一个植入装置，适合人类的乳突腔。该装置包括一个用于淋巴周围循环的外部可编程泵，一个通过耳蜗造口插入鼓室的耳蜗内导管，一个可编程的外部混合室，用于输送浓缩的生物活性化合物，以及用于检测和传输流量和压力信息的传感器。该系统的核心源自一种新型药物分配微系统，该系统是Draper团队在过去几年中设计、制造和测试的。超小型设备是一个完整的，长期（一年以上）的给药系统，包含治疗化合物，点药机构，控制电子设备和电源。该提案的目的是：(1)开发一种内耳接口，适合慢性、连续的再循环和输注化合物到淋巴管周围；(2)开发集成的微机械流体控制系统；(3)建立手术程序，确定乳突腔内植入的器械形状因素限制；(4)开发一种适合于一系列候选疗法的可植入药物储存、填充和释放机制；(5)开发低功耗控制电子、遥测、指定电源；(6)在初步动物实验中评估安全性和有效性，使用原型装置将化合物输送到内耳。