Disposable miniature check valve design suitable for scalable manufacturing

• We describe a novel, low-cost, passive one-way valve design.
• Valves are made independently, but can be readily integrated into fluidic systems.
• The valve cracking pressure can be tuned by varying easily controllable dimensions.
• The valves have low dead volume, in the range of 3–4 μL.
• The valves are compatible with nucleic acid amplification.

We present a passive, miniature check valve which can be manufactured using standard techniques ideal for low-cost, disposable systems used in medical devices and other applications. The body of the valve consists of a hollow cylindrical core, closed at one end, with a side port and a cylindrical elastomeric sleeve placed over the core body, covering the side port. The pressure required for initial opening of the valve, referred to as cracking pressure, can be adjusted, and depends predominantly on the valve core outer diameter, the sleeve inner diameter, the sleeve wall thickness, and the sleeve material's modulus of elasticity. These parameters can be controlled to tight tolerances, while the tolerances on other features can be relaxed, which simplifies valve manufacturing and assembly. Valve embodiments produced from different materials, and with varying critical dimensions, exhibited distinct and reproducible cracking pressures in the range of 2–20 PSI. The cracking pressure did not vary significantly as a function of flow rate. No back flow leakage was encountered up to 30 PSI, the pressure limit of the sensor used in this experiment. Most of the valves tested had small internal volumes of 3–4 μL. The internal volume can be further reduced by selecting a core of smaller inner diameter. In contrast to lithography-based microvalves that generally must be manufactured in situ within the fluidic device, the herein presented valve can be manufactured independently of, and can be readily integrated into fluidic systems manufactured via a wide selection of fabrication methods.