iOP-Connect System for Long-Term Continuous Monitoring of Glaucoma Therapy by means of an Implantable Autonomous Intraocular Pressure Sensor

iOP-Connect 系统通过植入式自主眼压传感器长期连续监测青光眼治疗

• 批准号: 10383459
• 负责人: Kevin Douglas BERG
• 金额: $ 99.35万
• 依托单位: INJECTSENSE, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-01 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10383459
• 关键词: Address; Adverse effects; Adverse event; Affect; Animal Testing; Animals; Blindness; Ceramics; Charge; Clinical; Clinical Research; Country; Custom; Data; Data Collection; Data Science; Development; Devices; Effectiveness; Engineering; Eye; Eye Injuries; Feasibility Studies; Funding; Future; Glaucoma; Goals; Gold; Human; Implant; Implantation procedure; Individual; Injectable; Institutes; Investigation; Length; Lithium; Manufacturer Name; Measurement; Measures; Medical; Medical Device; Microfabrication; Miniaturization; Monitor; Office Visits; Oryctolagus cuniculus; Outcome; Patient Care; Patients; Performance; Persons; Phase; Phosphorus; Physicians; Physiologic Intraocular Pressure; Pressure Transducers; Procedures; Production; Quality of life; Research Personnel; Risk; Safety; Sampling; System; Technology; Telemetry; Testing; Time; Tissues; Treatment Cost; Treatment Effectiveness; Treatment outcome; Universities; Vision; Work; aged; biomaterial compatibility; body position; commercialization; conjunctiva; data exchange; data integrity; design; experience; implantable device; implantation; improved; in vivo; innovation; innovative technologies; integrated circuit; microelectronics; millimeter; miniaturize; miniaturized sensor; minimally invasive; novel; operation; overtreatment; performance tests; personalized medicine; pre-clinical; preservation; pressure; pressure sensor; programs; prototype; remote assessment; research clinical testing; response; seal; sensor; sensor technology; solid state; standard of care; success; tonometry; tool; transmission process

Project Summary The iOP-Connect system is a medical device that incorporates novel microelectronics technology and data science to revolutionize glaucoma patient care by enabling long-term continuous monitoring of glaucoma therapy effectiveness. The iOP-Connect is the only continuous IOP-monitoring system technology to receive a Breakthrough Device Program designation from FDA. The goal of this Phase II project is to build on prior successful “Feasibility” outcomes (Phase I equivalent) by implementing innovative advancements in the iOP-Connect system design to achieve a final product configuration and prepare for future pivotal clinical study(s). The outcomes will inform and drive the rigorous GLP animal and clinical studies roadmap to generate safety and effectiveness data to support FDA approval. The iOP-Connect system innovates IOP measurement/monitoring beyond the current gold standard and, for the first time, enables real-time (e.g., daily remote) assessment of IOP-reduction effectiveness for glaucoma treatment. Injectsense enables this product by engineering innovative product features such as: 1) long-term ocular implant (IPM) with in-vivo safety and pressure sensor stability, 2)direct measurement of true IOP intravitreally, and 3) microbattery-enabled autonomous (non-disruptive) continuous logging of uninfluenced IOP. The IPM is the core enabling innovation of the system and is built on Injectsense’s proprietary microfabrication technology. The IPM is a millimeter-scale, long-term implantable device. It combines a capacitive microelectromechanical system (MEMS) pressure sensor, a sampling and digitizing application-specific integrated circuit (ASIC), an energy storage layer (battery), and a telemetry coil integrated and enclosed in an injectable carrier. In Feasibility studies, Injectsense used fundamentally novel miniaturization and packaging technologies to develop a functional implantable prototype (without the microbattery). Short-term non-GLP animal studies demonstrated: 1) the prototype can be safely implanted in the eyeball using a minimally invasive procedure with no adverse effects, 2) the prototypes were able to transmit IOP data on demand for one week, and 3) the IOP measurements were within 3mmHg of a reference tonometer. The Phase II objective is to develop a production-ready system that performs autonomous continuous measurement and logging of IOP data and telemetrically transmits the data via IOP-Connect. Aim 1 is to design, develop and build an implantable autonomous IOP sensor module, where the existing pressure sensing module incorporates: 1) a custom LiPON (lithium phosphorus oxynitride) solid-state microbattery for autonomous IOP data collection, and 2) an embedded ceramic inductor to improve reliability and stability of power transfer and telemetry. Aim 2 is to conduct non-GLP animal testing to verify in-animal autonomous system efficacy.

项目摘要 IOP连接系统是一种融合新型微电子技术和的医疗设备 数据科学通过长期连续监测来彻底改变青光眼患者护理 青光眼治疗有效性。 IOP连接是唯一连续的IOP监控系统 从FDA接收突破设备计划的技术。 该第二阶段项目的目标是建立以前成功的“可行性”结果（同等的）。 在IOP连接系统设计中实施创新的进步以实现最终产品 配置并为将来的关键临床研究做准备。结果将告知并驱动严格的 GLP动物和临床研究路线图，以生成安全性和有效性数据，以支持FDA批准。 IOP连接系统创新的IOP测量/监视超出了当前的黄金标准，并且 第一次，启用对青光眼的IOP降低有效性的实时（例如，每日远程）评估 治疗。注射史通过工程创新的产品功能，例如：1）长期来实现该产品 具有体内安全性和压力传感器稳定性的眼科植入物（IPM），2）直接测量真实IOP 玻璃体内和3）启用微生物的自主（非破坏性）连续记录未受影响的IOP。 IPM是使系统创新的核心 技术。 IPM是一种毫米规模的长期植入器设备。它结合了电容 微电动机电系统（MEMS）压力传感器，采样和数字化应用特定于 集成电路（ASIC），储能层（电池）和遥测线圈集成并封闭在一个 注射载体。 在可行性研究中，注射义从根本上使用新颖的小型化和包装技术来 开发功能性植入原型（没有微生物）。短期非GLP动物研究 证明：1）可以使用最小的侵入性步骤在眼球中安全地实现原型 没有不利影响，2）原型能够按需传输IOP数据，而3）IOP 测量值在参考文能计的3mmHg之内。 第二阶段目标是开发一种可以执行自动连续的生产的系统 IOP数据的测量和记录并通过IOP连接传输数据。目标1是设计， 开发并建立一个可植入的自动iop传感器模块，现有压力传感器模块 合并：1）自主iop的定制lipon（磷氯磷氯二硝酸锂）固态微生物 数据收集，以及2）诱导的嵌入式陶瓷，以提高电力传输的可靠性和稳定性和 遥测。 AIM 2是进行非GLP动物测试以验证自主系统效率。