Patent EP-2537548-A3 (EP)
Inventor: FLORKIEWICZ EMIL
IPC: A61M15/00
Filed: 2012-06-19
Abstract: The invention refers to a method for controlling and monitoring of the device (A) for generation of the aerosol during metering of a medicament dose by the inhalation method through the device (U) for controlling the aerosol generation and for monitoring the dose, which utilizes any type of the supervised device (A) for generation of the aerosol during metering of the medicament dose by the inhalation method, preferably a pressure nebuliser, ultrasonic inhaler or other similar type inhaler of known operational parameters, wherein during generation of the aerosol while metering of the dose by the supervised device the exceeding of the pressure threshold value in the pressure line, connected to a mouthpiece of the supervised device is read, which means the start of the inspiration phase and the start of the generation of the aerosol by the supervised inhalation device, until the moment of re-exceeding of the threshold pressure value in the pressure line, which is interpreted as an exhalation phase, or a break of breathing, characterized in that the supervised device (A) is combined into a single unit with a device (U) for controlling of the generation of an aerosol and monitoring of the metered dose, which unit is controlled according to the respiratory phases of the inspiration and exhalation, wherein individual calibration of the device (U) is performed for each unit formed in this way, determining for it the individual threshold pressure value for pressure sensor (4), which is recognized as the beginning of the inspiration phase and exhalation phase and the threshold aerosol volume value and the threshold time value of the duration of the aerosol generation, afterwards the generation of the aerosol during metering of the pre-set dose is started, during which, the individual measured instantaneous volumes of the aerosol, used to metering of the dose in each single measuring cycle are recorded and summed at a real time by the controlling and monitoring device (U), as well as the instantaneous aerosol generation times, measured in single measurement cycles are recorded and summed, and the metering of the delivered dose is controlled and monitored, wherein the process of the generation of the aerosol during metering of the dose in the supervised inhalation device (A) is completed at a time when the volume of the generated aerosol used for metering of the dose, which is a sum of the instantaneous volumes measured in single measurement cycles exceeds the threshold value of the aerosol volume described by the volume of the aerosol, in which a dose equal to the pre-set dose is contained and/or when the time used effectively for the generation of the aerosol during metering of the dose, which is the sum of the instantaneous times of the generation of the aerosol, measured in single measurement cycles, exceeds the threshold time value of the generation of the aerosol, determined by the total time required to disperse the pre-set dose. 
     The invention also relates to the control and monitoring device (U) of the supervised device (A) to generate the aerosol during the medicament dose metering.