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

项目摘要 IOP-Connect系统是一种医疗设备，它结合了新的微电子技术和 数据科学通过实现对青光眼患者的长期持续监测来彻底改变青光眼患者的护理 青光眼治疗效果。IOP-Connect是唯一的连续眼压监测系统 获得FDA指定的突破性设备计划的技术。 该第二阶段项目的目标是在之前成功的“可行性”成果(相当于第一阶段)的基础上，通过 在IOP-Connect系统设计中实施创新进步，以实现最终产品 配置并为未来的关键临床研究做准备(S)。结果将告知并推动严格的 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的批准。 IOP-Connect系统创新了眼压测量/监控，超越了当前的黄金标准，对于 首次启用青光眼降眼压效果的实时(例如，每日远程)评估 治疗。InjectSense通过设计创新的产品功能来支持该产品，例如：1)长期 具有体内安全性和压力传感器稳定性的眼科植入物(IPM)，2)直接测量真实眼压 玻璃体内，以及3)启用微电池的自主(无中断)连续记录不受影响的眼压。 IPM是实现系统创新的核心，并建立在InjectSense的专有微制造基础上 技术IPM是一种毫米级的长期可植入设备。它结合了一个电容式 微型机电系统(MEMS)压力传感器，特定于采样和数字化应用 集成电路(ASIC)、储能层(电池)和遥测线圈集成并封装在 可注射载体。 在可行性研究中，InjectSense从根本上使用了新颖的微型化和包装技术 开发功能可植入的原型(不带微电池)。短期非GLP动物研究 证明：1)原型可以安全地植入眼球，使用微创程序 没有不良影响，2)原型能够按需传输IOP数据一周，以及3)IOP 测量结果与参考眼压计的测量结果在3毫米汞柱以内。 第二阶段的目标是开发一个生产准备就绪的系统，该系统可以自动连续地执行 测量和记录眼压数据，并通过IOP-Connect远程传输数据。目标1是设计， 开发和构建可植入的自主眼压传感器模块，其中现有的压力传感模块 集成：1)用于自主IOP的定制LiPon(锂磷氮化物)固态微电池 数据采集，2)嵌入式陶瓷电感，提高电能传输的可靠性和稳定性 遥测技术。目的2是进行非GLP动物试验，以验证动物体内自主系统的有效性。

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.