Telemetric Implantable Intraocular Pressure Sensor Syste

遥测植入式眼压传感器系统

• 批准号: 6631393
• 负责人: Lawrence Wan
• 金额: $ 27.23万
• 依托单位: BIOMEMS, LLC
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-05-01 至 2004-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6631393
• 关键词: biomedical equipment development; computer simulation; diagnosis design /evaluation; eye disorder diagnosis; glaucoma; implant; intraocular pressure; medical implant science; microprocessor /microchip; miniature biomedical equipment; monitoring device; telemetry

DESCRIPTION (provided by applicant): This research will assess the technical feasibility of developing a new and unique miniature ophthalmic lOP sensor, to be retrofitted into the cannula of a conventional Glaucoma Drainage Device and surgically implanted under the sclera for the purpose of continuous measurement and transmission of these lOP readings to a remote receiver. With this technology, physicians will have the ability to measure the effects that medications and other life-style factors have on the lOP of their patients in a real-time and continuous mode. Current technology does not allow for real-time, continuous (24/7, diurnal and nocturnal readings) monitoring of intraocular pressure (lOP) to enable physicians to study, diagnose and more clearly understand the response mechanism relating to lOP that can lead to more effective development and titration of glaucoma medications or other timely therapeutic options. Elevated and fluctuating (lOP) 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 research is dedicated to developing technologies that assist physicians to more effectively treat the glaucoma patient. With regard to glaucoma, Brian Francis, MD, of the Doheny Eye Institute, has stated that: "lntraocular Pressure (lOP) is the only treatable risk factor known. Three (3) recent NIH clinical trials have shown the importance of IOP control, even in the normal tension glaucoma patient. These are the 1) Normal Tension Glaucoma Study, the 2) Advanced Glaucoma Intervention Study, part 7, and 3) The Ocular Hypertension Treatments Study. The Importance of lOP has been clearly established, and is the gauge by which all current drug and surgical treatments are measured." The initial stage of research and development delineated here will consist of proving the proposed concept by means of a "breadboard design". An original MEMS lOP sensor chip will be designed and fabricated which will employ a capacitive resonance and resistance effect, and the interface electronics materials and electronic chip (ASIC) and other items which form the telemetry signal will be outsourced. Advanced work will involve bonding an lOP MEMS sensor to the electronic chip (ASIC) and integrating it into a conventional Glaucoma Drainage Device (GDD) for implantation into humans. For this project, a computer designed silicon, piezoelectric pressure sensor and computer simulation of the lOP sensor and process will be developed along with a bench-top proof-of-concept prototype and functional process of 1) the lOP sensor, 2) the ASIC chip signal processor, and 3) the remote hand control device. Validations will be performed in the computer simulation of the MEMS pressure sensor chip and its ability to detect the pressure over the expected eye pressure ranges (0-40 mm Hg) from a remote distance of 4-6 feet. The bench-top model will demonstrate three functions, which will be initiated and activated remotely, A) intraocular pressure sensing, B) signal processing of those pressures using an inductance energy field, and C) transmission of the pressure readings to a remote device. Two extensive reports will be generated, i) a pressure sensor design, ASIC design, and MEMS lOP specification sheet with drawings, and I1)documentation of the experiment using the prototype configuration and commonly accepted intraocular testing rigs used to calibrate commercially available tonometers, that can lead researchers to develop more effective pharmaceuticals or therapeutic protocols for the glaucoma patent.

描述（由申请人提供）：本研究将评估开发新的独特微型眼科LOP传感器的技术可行性，将在常规青光眼排水装置的插座中进行改装，并在巩膜下进行手术植入，以进行连续测量和连续测量和连续测量将这些LOP读数传输到远程接收器。借助这项技术，医生将有能力衡量药物和其他生活方式因素对患者的LOP的实时和连续模式的影响。 当前的技术不允许对眼内压（LOP）进行实时，连续（24/7，昼夜读数）监测，以使医生能够研究，诊断并更清楚地了解与LOP有关的反应机制，从而导致更多的反应机制有效开发和滴定青光眼药物或其他及时的治疗选择。在24/7期间，升高和波动（LOP）是短期内眼睛损害的独立且可证明的风险因素，长期内的青光眼进展，如果保持不受控制或未受管理的话，可能会导致失明。这项研究致力于开发技术，以帮助医生更有效地治疗青光眼患者。 关于青光眼，Doheny Eye Institute的医学博士Brian Francis表示：“ Lntrocular Werferwe（LOP）是已知的唯一可治疗的风险因素。三（3）个NIH最近的NIH临床试验表明，IOP对照的重要性，IOP控制的重要性，IOP控制的重要性，即使在正常的张力青光眼患者中。 高血压治疗研究。 LOP的重要性已经明确确定，是测量当前药物和手术治疗的量规。将设计和制造一个原始的MEMS LOP传感器芯片，该芯片将采用电容性共振和电阻效果，以及接口电子材料和电子芯片（ASIC）和电子芯片（ASIC）和 构成遥测信号的其他项目将被外包。高级工作将涉及将LOP MEMS传感器粘合到电子芯片（ASIC），并将其集成到常规的青光眼排水装置（GDD）中，以植入人类。对于该项目，将开发一款计算机设计的硅，压电压力传感器和LOP传感器的计算机模拟，并将与台式概念验证原型和功能过程一起开发1）LOP传感器，2）ASIC芯片信号处理器和3）远程手部控制设备。将在MEMS压力传感器芯片的计算机模拟中进行验证，并在预期的眼压范围（0-40 mm HG）上检测到从4-6英尺的远程检测压力的能力。台面模型将展示三个函数，将远程启动并激活，a）眼内压力感应，b）使用电感能场对这些压力进行信号处理，c）压力读数的传播 到远程设备。将生成两项广泛的报告，i）带有图纸的压力传感器设计，ASIC设计和MEMS LOP规范表，以及I1）使用原型配置和常见的经常接受的眼内测试钻机进行实验的文档，用于校准商业可用的TOMENOMETERS，这些钻机（可以领导研究人员为青光眼专利开发更有效的药物或治疗方案。

项目成果

Prevention of Staphylococcus aureus endophthalmitis with topical gatifloxacin in a rabbit prophylaxis model.

在兔预防模型中用局部加替沙星预防金黄色葡萄球菌眼内炎。

• DOI: 10.1089/jop.2006.22.132
• 发表时间: 2006
• 期刊: Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics
• 作者: deCastro,LuisEFernandez;Sandoval,HelgaP;Bartholomew,LuannaR;Vroman,DavidT;Solomon,KerryD
• 通讯作者: Solomon,KerryD