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-Connect系统是一种融合了新型微电子技术的医疗器械， 数据科学通过实现长期连续监测，彻底改变青光眼患者护理 青光眼治疗效果。iOP-Connect是唯一的持续IOP监控系统 技术获得FDA的突破性器械计划认定。 第二阶段项目的目标是在先前成功的“可行性”成果（相当于第一阶段）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 配置和准备未来的关键临床研究。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，支持FDA批准。 iOP-Connect系统创新了IOP测量/监测，超越了当前的黄金标准， 第一时间，使能实时（例如，每日远程）评估IOP降低对青光眼的有效性 治疗Injectsense通过设计创新的产品功能使该产品成为可能，例如：1）长期 具有体内安全性和压力传感器稳定性的眼植入物（IPM），2）直接测量真实IOP 玻璃体内，和3）微电池使能的自主（非破坏性）连续记录未受影响的IOP。 IPM是该系统的核心创新，建立在Injectsense专有的微加工基础上。 技术. IPM是一种毫米级的长期植入式设备。它结合了电容式 微机电系统（MEMS）压力传感器，一种采样和数字化应用特定的 集成电路（ASIC）、能量存储层（电池）和遥测线圈，其被集成和封装在一个或多个集成电路（ASIC）中。 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， 开发一个功能性的可植入原型（没有微电池）。短期非GLP动物研究 证明：1）原型可以使用微创手术安全地植入眼球中， 无不良影响，2）原型能够按需传输IOP数据一周，3）IOP 测量值在参考眼压计的3 mmHg内。 第二阶段的目标是开发一个生产就绪的系统， 测量和记录IOP数据，并通过IOP连接遥测传输数据。目标1是设计， 开发和构建可植入自主IOP传感器模块，其中现有的压力传感模块 包括：1）定制的LiPON（锂磷氮氧化物）固态微电池，用于自主IOP 数据收集，以及2）嵌入式陶瓷电感器，以提高功率传输的可靠性和稳定性，以及 遥测技术目的2是进行非GLP动物试验，以验证动物自主系统的有效性。