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: 10556408
• 负责人: Kevin Douglas BERG
• 金额: $ 62.4万
• 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 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10556408
• 关键词: Address; Adverse effects; Adverse event; Affect; Animal Testing; Animals; Blindness; Breakthrough device; Ceramics; Charge; Clinical; Clinical Research; Country; Custom; Data; Data Collection; Data Science; Development; Devices; Effectiveness; Electronics; Engineering; Eye; Eye Injuries; Feasibility Studies; Funding; Future; Glaucoma; Goals; Human; Implant; Implantation procedure; Individual; Injectable; Length; Lithium; Manufacturer; 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 Reduction; Safety; Sampling; Specific qualifier value; 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; manufacturing technology; microelectronics; millimeter; miniaturize; miniaturized sensor; minimally invasive; novel; operation; performance tests; personalized medicine; pre-clinical; preservation; pressure; pressure sensor; programs; prototype; research clinical testing; response; seal; sensor; sensor technology; solid state; standard of care; success; technology platform; 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.

项目概要 iOP-Connect 系统是一种医疗设备，融合了新颖的微电子技术和 数据科学通过长期连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 IOP 监测系统 技术获得 FDA 突破性设备计划指定。 该第二阶段项目的目标是在先前成功的“可行性”成果（第一阶段等效）的基础上 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好准备。结果将告知并推动严格的 GLP 动物和临床研究路线图，用于生成安全性和有效性数据以支持 FDA 批准。 iOP-Connect 系统对 IOP 测量/监测进行了创新，超越了当前的黄金标准，并且 首次实现青光眼眼压降低效果的实时（例如每日远程）评估 治疗。 Injectsense 通过设计创新产品功能来实现该产品，例如：1) 长期 具有体内安全性和压力传感器稳定性的眼部植入物（IPM），2）直接测量真实眼压 玻璃体内，3) 微电池支持的自主（无中断）连续记录不受影响的 IOP。 IPM 是系统创新的核心，建立在 Injectsense 专有的微加工技术之上 技术。 IPM 是一种毫米级的长期植入设备。它结合了电容 微机电系统 (MEMS) 压力传感器，采样和数字化特定应用 集成电路 (ASIC)、能量存储层（电池）和集成并封装在一个封装中的遥测线圈 可注射载体。 在可行性研究中，Injectsense 使用了全新的小型化和封装技术 开发功能性植入原型（无微电池）。短期非 GLP 动物研究 证明：1）原型可以通过微创手术安全地植入眼球 无不良影响，2) 原型机能够按需传输一周的 IOP 数据，以及 3) IOP 测量值与参考眼压计的误差在 3mmHg 以内。 第二阶段的目标是开发一个可立即生产的系统，该系统可以执行自主连续操作 测量和记录 IOP 数据，并通过 IOP-Connect 遥测传输数据。目标 1 是设计， 开发并构建植入式自主 IOP 传感器模块，其中现有压力传感模块 包含：1) 用于自主 IOP 的定制 LiPON（氮磷锂）固态微电池 数据收集，以及 2) 嵌入式陶瓷电感器，以提高电力传输的可靠性和稳定性 遥测。目标 2 是进行非 GLP 动物测试，以验证动物自主系统的功效。