Improved glycemic control with insulin pump therapy in patients with type 1 diabetes mellitus has shown gradual reductions in nephropathy and retinopathy. More recently, the emerging concept of the artificial pancreas, comprising an insulin pump coupled to a continuous glucose meter and a control algorithm, would become the next major breakthrough in diabetes care. The patient safety and the efficiency of the therapy are directly derived from the delivery accuracy of rapid-acting insulin. For this purpose, a specific precision-oriented design of micropump has been built. The device, made of a stack of three silicon wafers, comprises two check valves and a pumping membrane that is actuated against stop limiters by a piezo actuator. Two membranes comprising piezoresistive strain gauges have been implemented to measure the pressure in the pumping chamber and at the outlet of the pump. Their high sensitivity makes possible the monitoring of the pumping accuracy with a tolerance of ±5% for each individual stroke of 200 nL. The capability of these sensors to monitor priming, reservoir overpressure, reservoir emptying, outlet occlusion and valve leakage has also been studied.
We report on the fabrication of the first MEMS micropump including an integrated pressure sensor. The signal of this sensor allows direct insight into the pump's operating dynamics and enables real-time self-monitoring. We demonstrate the changes in the sensor signal under different pumping conditions, including the presence of air in the pumping chamber and a downstream occlusions. Deviations from normal operating conditions create clear and characteristic deviations from the normal signal. These deviations will be exploited to detect extraordinary or faulty pumping conditions during use.
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