Wireless Implantable Intraocular Pressure Sensor System

描述(申请人提供)：这项研究将评估开发一种新型和独特的微型眼压(IOP)传感器的技术可行性，该传感器将改装到传统青光眼引流装置(GDD)的套管中，并通过手术植入巩膜下，以连续测量这些眼压读数并将其传输到远程接收器。目前的技术不允许实时、连续地监测眼压(全天候、日间和夜间读数)。该项目的长期目标是使医生能够研究、诊断和更清楚地了解与眼压有关的反应机制，从而能够更有效地开发和滴定青光眼药物或其他及时的治疗方案。眼压全天候升高和波动是短期内眼睛受损和长期青光眼进展的独立且已被证实的风险因素，如果不加控制或不加以管理，可能会导致失明。这项第二阶段的研究致力于开发帮助医生更有效地治疗青光眼患者的技术。这与国家眼科研究所的使命是一致的。在第二阶段，具体目标包括系统微型化、包装和生物兼容性。研发将具体涉及设计、制造各种MEMS和ASIC芯片，并将其集成到一个单元化的微型芯片中，以执行一系列系统活动(即功率传输[RF-ID]、芯片询问、IOP数据捕获和存储、无线数据传输、修复、解决方案等)。这些方法包括设计输入、产品开发、产品集成(MEMS传感器、ASIC和生物兼容材料)以及产品验证和测试。总之，有了这种遥测眼压传感技术，医生将能够以实时和连续的模型测量药物和生活方式因素对患者眼压的影响。

DESCRIPTION (provided by applicant): This research will assess the technical feasibility of developing a new and unique miniature ophthalmic intraocular pressure (IOP) sensor, to be retrofitted into the cannula of a conventional Glaucoma Drainage Device (GDD) and surgically implanted under the sclera for the purpose of continuous measurement and transmission of these IOP readings to a remote receiver. Current technology does not allow for real-time, continuous monitoring of IOP (24/7, diurnal and nocturnal readings). The long-term objective of this project is to enable physicians to study, diagnose and more clearly understand the response mechanism relating to IOP that can lead to more effective development and titration of glaucoma medications or other timely therapeutic options. Elevated and fluctuating IOP over a 24/7 period is an independent and proven risk factor for eye damage in the short term and glaucoma progressions in the long term, which if left unchecked or unmanaged could lead to blindness. This Phase II research is dedicated to developing technologies that assist physicians to more effectively treat the glaucoma patient. This is inline with the mission of the National Eye Institute. Under Phase II, specific aims include system microminiaturization, packaging and biocompatibility. Research and development will specifically involve designing, fabricating, and integrating various MEMS and ASIC chips into a unitized singular micro scale chip to perform a number of systems activities (i.e. power transfer [RF-ID], chip interrogation, IOP data capture and storage, wireless data transfer, remediation, resolution, etc.) involving methods researched and determined in the successful portion of Phase I. These sequential methods include design input, product development, product integration (MEMS sensor, ASIC & biocompatible materials) and product validation and testing. In conclusion, with this telemetric IOP sensing technology, physicians will be able to measure the effects that medications and life-style factors have on the IOP of their patients in a real- time and continuous model.