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

描述（由申请人提供）：该项目涉及、提出、开发和原型化nih驱动项目的核心组件，以开发针对糖尿病患者胰岛素治疗的硅基闭环药物输送系统。该组件是一个硅微阀，满足了低功耗、低成本和小型化（< 0.25 cm3）胰岛素计量设备的需求，能够控制精确和分数（纳升）的液体体积。创新的新设计，有效的材料使用，以及在硅片上可重复，可制造和晶圆级制造和组装压电致动器的新兴方法，允许在相同或更低的功率水平下，以更低的成本实现比以前可实现的大10-100倍的静态位移和力。第一阶段将解决设计问题、装配挑战、材料和流体兼容性，以及为最终用户提供工程规范驱动的微阀原型。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，操作压力范围，闭塞管理和长期循环加载条件。将使用这些度量来评估技术可行性。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、工艺改进和成本降低。该组件的适应性、便携的低功耗能力和大动态范围在体外和体内给药的阀门、计量和压力调节、青光眼的眼内压缓解、脑积水的压力管理以及呼气测醉器中的气体流量控制等方面都有应用。设计理念和制造方法，在产生许多祖先组件产品的同时，广泛适用于集成传感器和电子设备的硅平台，在这种特殊情况下，适合于闭环胰岛素输送系统的微阀技术。

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.