Low-Power Cost-Effective Silicon Microvalves for Drug Delivery and Insulin Therap

描述（由申请人提供）：该项目的地址，建议，开发和原型的NIH动机计划的核心组成部分，以开发基于硅的闭环药物输送系统，针对糖尿病胰岛素治疗。该组件是一个硅微阀，满足了对低功率、低成本和小型化（< 0.25 cm 3）胰岛素计量装置的需求，该装置能够控制精确和分数（纳升）的液体体积。创新的新设计、材料的有效使用以及用于在硅晶片上的压电致动器的可重复的、可制造的和晶片规模的制造和组装的新兴方法允许在相同或更低的功率水平下并且以更低的成本实现比先前可获得的静态位移和力大10-100倍的静态位移和力。第一阶段将解决设计问题，组装，材料和流体兼容性的挑战，并为最终用户的工程规格驱动的微型阀原型。这些规范将详细说明可接受的泄漏率、峰值和平均功率水平、工作压力范围、闭塞管理和长期循环载荷条件。将使用这些指标评估技术可行性。第二阶段的验证将来自最终用户的反馈，并将导致设计改进，过程改进和成本降低。所提出的组件的适应性，其低功耗的便携性，以及其大的动态范围的应用在阀门，计量和压力调节的体外和体内药物输送，眼内压（IOP）缓解青光眼，脑积水的压力管理，和气体流量控制呼吸测醉器。设计理念和所采取的制造方法，在产生许多祖组件产品的同时，广泛地适用于传感器和电子器件集成的硅平台，并且在这种特定情况下，适用于符合闭环胰岛素输送系统愿景的微阀技术。 公共卫生相关性：糖尿病影响着美国2400万人，另有5700万人是糖尿病前期，而且人数和百分比都在增长。该项目开发了“人工胰腺”的核心部件-硅微阀。人工胰腺替代了I型糖尿病患者的功能失调的真实的器官。微型阀将满足低功率和廉价的胰岛素输送装置的需要，利用新的设计和材料，以满足以前无法达到的性能规格。微型阀是迈向集成系统的关键一步，该系统比传统解决方案体积更小，成本更低，更智能，并且是在制造平台上开发的，用于传感器和电子器件的高效和快速集成。

DESCRIPTION (provided by applicant): This project addresses, proposes, develops, and prototypes a core component of an NIH-motivated program to develop a silicon-based closed-loop drug delivery system targeted for insulin therapy of diabetics. The component, a silicon microvalve, fulfills a need for a low-power, low-cost and miniaturized (< 0.25 cm3) insulin metering device with the ability to control precise and fractional (nanoliter) volume of fluids. Innovative new designs, efficient usage of materials, and emerging methods for repeatable, manufacturable, and wafer-scale fabrication and assembly of piezoelectric actuators on silicon wafers, allow for 10-100 times larger static displacements and forces than previously attainable, at the same or lower power levels, and at lower cost. Phase I will address design issues, challenges in assembly, materials and fluids compatibility, and prototyping of engineering-spec-driven microvalves for end-users. These specifications will be detailed in acceptable leak rates, peak and average power-levels, operating pressure ranges, management of occlusions, and long-term cyclic loading conditions. The technical feasibility will be assessed using these metrics. Validation for Phase II will come from end-user feedback, and will lead to design refinements, process improvements, and cost- reduction. The adaptability of the proposed component, its low-power capabilities for portability, and its large dynamic range has applications in valving, metering, and pressure regulation for in-vitro and in-vivo drug delivery, intraocular pressure (IOP) relief for glaucoma, pressure management for hydrocephalus, and gas flow control in breathalyzers. The design philosophy and the manufacturing approach taken, while generating many progenitor component products, lends itself broadly to a silicon platform for integration of sensors and electronics, and in this specific case, to a microvalve technology that fits into a vision for a closed-loop insulin delivery system. PUBLIC HEALTH RELEVANCE: Diabetes affects 24 million people in the United States, an additional 57 million are pre-diabetic, and the numbers and percentages are growing. This project develops a core component of an "artificial pancreas" - a silicon microvalve. An artificial pancreas substitutes for the real organ that in Type 1 patients has become dysfunctional. The microvalve will fulfill a need for a low-power and inexpensive insulin delivery device utilizing new designs and materials to meet performance specifications previously unattainable. The microvalve is a key step towards an integrated system that will be less bulky, less expensive, and more intelligent than conventional solutions, and is developed on a manufacturing platform for efficient and ready integration of sensors and electronics.