INHALER

Description

[0001] The present invention relates to an inhaler comprising a housing, an air duct extending between at least one air inlet opening and a suction opening in the housing, a delivery element for nebulizing or vaporizing liquid supplied by the delivery element for mixing with air flowing in the air duct, an electronic control device, an electronic data storage device and a sensor system with a flow measuring device for measuring the volume and / or mass flow of the air flowing through the air duct.

[0002] Such an inhaler is known, for example, from EP 3 574 779 A2.

[0003] Modern electronic cigarette products and inhalers deliver the active ingredient via a preset, user-independent delivery mechanism comprising a control unit and a delivery element. The control unit activates the delivery element, for example, in response to a negative pressure measured by a sensor during an inhalation. The amount of active ingredient delivered is essentially determined by the activation duration of the delivery element. A delivery element can be a heating element, an ultrasonic nebulizer that vaporizes or atomizes liquid using a piezoelectric element, a gas compressor that builds up gas pressure and thereby atomizes or vaporizes liquid through a nozzle, or a nebulizing membrane in which liquid is vaporized or atomized by high-frequency vibration of the membrane.

[0004] Since there is currently no correlation between the dosage control and the user-specific amount of air drawn through the inhaler during a single inhalation (e.g., the amount of air drawn differs between a strong and a weak inhalation), the vapor quality—that is, the amount of active ingredient per volume of air and the droplet size distribution—is essentially dependent on the individual user's inhalation technique. This can negatively affect both the reproducible smoking experience and a defined drug delivery in terms of quantity and timing within the inhaled air volume.

[0005] US Patent 10,602,781 B2 discloses a device for generating aerosols, comprising an atomizer with a heater. The device also includes a sensor for measuring flow rate or pressure. To adjust the power supplied to the heater, the values ​​measured by the sensor are compared to threshold values. If these threshold values ​​are exceeded or fallen below, the power supplied to the heater is adjusted.

[0006] US patent 2019 / 0289919 A1 discloses a capsule for an electronic evaporation device with a memory on which information is stored that is used to control the evaporation.

[0007] US patent 2017 / 0318861 A1 discloses an inhalation device with a heater for vaporizing liquid. It also includes a draft detection device that can detect when a user pulls on the inhalation device and consequently activate the heater.

[0008] US patent 9,854,841 B2 discloses an electronic smoking device with a liquid capacity sensor.

[0009] WO 2017 / 192767 A1 discloses a droplet dispensing device with a device designed to measure aerosol dispensing.

[0010] US Patent 5,363,842 A discloses an inhaler that can signal the success or failure of an inhaler activation.

[0011] Furthermore, CA 3 098 180 A1 describes an inhalation device that can capture and measure characteristic patterns in real time during use. The inhalation device can be used in a wireless communication mode to communicate with a display and to assess the subject's use of the inhalation system simultaneously with inhalation.

[0012] The object of the present invention is to provide an inhaler with improved reproducibility of both the smoking or vapor experience and the dosage of the active ingredient.

[0013] The invention solves this problem with the features of the independent claims.

[0014] According to the invention, a plurality of airflow measurements are acquired over part or all of the duration of an inhalation. These measurements are then compared with a breath profile stored in the data memory. A control signal is output based on the result of this comparison. The stored breath profile can be considered a calibration. The airflow measurements are volumetric and / or mass flow values, and / or pressure changes, measured by the flow meter over time within the area of ​​the inhaler through which the mass flow passes during the inhalation.A draw profile within the meaning of the invention is a defined ideal temporal profile of an air or air-vapor volume flow (and / or mass flow) that flows through the inhaler during at least part or during the entire ideal inhalation draw of the user. According to the invention, a comparison is made between the predetermined draw profile and measured values ​​recorded during a specific inhalation draw.

[0015] The invention provides, in particular, feedback based on the measured airflow profile during an inhalation, and preferably also on the amount of active ingredient / liquid delivered during the inhalation. Due to the preferred feedback between the airflow profile during an inhalation, and preferably also on the amount of active ingredient / liquid delivered during the inhalation, based on the result of a comparison with an ideal inhalation profile, a defined and reproducible drug delivery or an indication to the user of incorrect inhaler use is possible. Through the control system according to the invention, the inhaler essentially adapts to a user by taking into account the individual user's breath during the delivery of the active ingredient or liquid into the airflow.

[0016] Alternatively, it is conceivable that the inhaler has a fixed drug delivery profile and the user is trained to adhere to a matching airflow - i.e., inhalation profile - through appropriate feedback, by signaling deviations to the user accordingly.

[0017] According to the invention, if the airflow measurements deviate from the stored airflow profile in a defined manner, the control signal triggers a suitable action. The suitable action preferably comprises adjusting the control of the heating element (more precisely, the heating current flowing through the heating element and / or the heating duration and / or a pulse-pause ratio of the control), adjusting the vibration speed of a piezoelectric element or a nebulizing membrane, or adjusting the exit velocity of a compressed gas from a nozzle by setting a gas pressure, e.g., the atmospheric pressure for the amount of liquid to be administered, and / or signaling corresponding information to a user on a signaling device.

[0018] Based on the comparison of flow rate measurements and inhalation profile, various alternative responses are possible. One preferred option is to signal to the inhaler user via a suitable signaling device if, for example, the amount of medication delivered during the inhalation was insufficient. In the event of an excessively strong inhalation and a potential overdose, the electronic control system can prevent the administration of the medication, thus avoiding adverse drug reactions or, in an emergency, initiating appropriate measures (e.g., calling an ambulance or emergency physician).

[0019] Another preferred approach involves adjusting the drug delivery into the air / air-vapor volume flow based on the degree of deviation of the measured values ​​from the draft profile. This adjustment is achieved by appropriately controlling the delivery device or the heating element, piezoelectric element, nebulizer membrane, or air compressor. For this purpose, the heating current flowing through the heating element is adjusted based on the control signal. If the heating current is advantageously controlled using digital pulse-width modulation (PWM) with two discrete states, one or more of the following parameters can be used to adjust the heating current: duration of the ON state (voltage applied); duration of the OFF state (no voltage applied); the ratio between the duration of the ON state and the duration of the OFF state (pulse-pause ratio); other activation / deactivation limits, such as the resistance limits of the heater; and the level of the signal.the voltage applied to the heating element during the ON state.

[0020] It is also possible to carry out both of the previously described reactions. For example, an attempt can first be made to adjust the amount of active ingredient delivered via vaporization control, i.e., adjusting the control of the heating element or the heating current flowing through the heating element. If this is no longer possible during the respective inhalation, e.g., due to a significant deviation of the measured values ​​from the inhalation profile, the user can be notified of the deviation from the inhalation profile at the end and / or after the inhalation, allowing them to adjust their inhalation. Should such an adjustment of the inhalation prove insufficient, the user can be notified of an incorrect dosage.

[0021] The feedback system preferred according to the invention can advantageously be implemented by a suitable control loop, in particular comprising a digital electronic control device (for example, a microprocessor), an electronic, in particular non-volatile, data storage device, and a sensor system or a part thereof. The electronic data storage device is configured to permanently store at least one inhalation profile. The sensor system has a flow measuring device configured to measure the temporal profile of the air / air-vapor volume flow during a specific inhalation. The electronic control device is expediently connected to the sensor system, the data storage device, the heating element, and any signaling device that may be present.

[0022] The flow meter can advantageously be a differential pressure meter, which enables reliable measurement of the air volume flow (or air mass flow) in a portable inhaler using simple means. In this embodiment, the differential pressure meter comprises a first pressure sensor arranged to measure the ambient air pressure of the inhaler and a second pressure sensor arranged to measure the air pressure in the inhaler's air channel. Knowing the cross-sectional area of ​​the air channel at the measuring point of the second pressure sensor and the pressure difference measured between the first and second pressure sensors, the air volume flow through the inhaler can be determined.

[0023] In another embodiment, the flow measuring device can advantageously be a hot-wire measuring device (thermal anemometer). In this device, at least one wire element arranged in the air duct of the inhaler is electrically heated. The flow around the wire element causes heat transfer into the flowing air, i.e., the wire element is cooled. By measuring the temperature-dependent electrical resistance, the flow velocity, and thus the volumetric flow rate, of the air flowing through the air duct can be determined.

[0024] The flow measuring device also allows for the determination of the air volume flow over time. This advantageously yields a "puff" profile or a measured draft profile of the entire train.

[0025] Preferably, the sensor system includes a liquid volume sensor for measuring the amount of liquid delivered by a vaporization device during an inhalation. This allows for a more precise adjustment of the amount of liquid to be vaporized to the individual inhalation profile of the consumer.

[0026] In an advantageous embodiment, the liquid quantity sensor is a humidity sensor. The humidity sensor preferably comprises two humidity sensors arranged in the air duct of the inhaler to measure the humidity. The first humidity sensor is located in the air inlet area or upstream of the heating element in the air duct and measures a reference humidity value before the addition of liquid vapor. The second humidity sensor is located downstream of the heating element in the air duct, for example, in the mouthpiece area, and measures the humidity immediately before the user inhales the air-aerosol vapor mixture. With a known amount of water in the liquid to be vaporized and a calibrated second humidity sensor, the increase in humidity, i.e.,The difference in measured values ​​from the second and first moisture measuring elements determines the amount of liquid that has evaporated and is subsequently taken into account.

[0027] A changing water content in the liquid due to differential distillation during the emptying of the cartridge can be advantageously compensated by determining the residual liquid quantity in the liquid tank using a level sensor (see below) or by estimating it by counting the puffs in conjunction with measuring the puff duration.

[0028] Based on the determined residual liquid volume and the knowledge of differential distillation, the current water content can be calculated, and the measured humidity value can be corrected accordingly. Furthermore, the amount of active ingredient evaporated can be determined from the determined or estimated amount of evaporated liquid, taking into account the concentration of the active ingredient in the liquid.

[0029] The sensor system advantageously includes a level sensor for detecting the remaining liquid quantity in the inhaler's liquid tank. The level sensor can, for example, be a capacitive sensor. The remaining liquid quantity in the tank can be easily determined from the liquid level measured by the level sensor. The electronic control device is preferably configured to determine the time remaining until a cartridge change is required, based on the remaining liquid quantity measured by the level sensor, for example, taking into account a previous usage profile stored in the data memory.

[0030] Alternatively, the level sensor can be based on absorption measurement. For this, a light source with a defined wavelength, such as an LED or a laser, and a light-sensitive element (photocell), such as a photodiode, are arranged in or relative to the air duct such that the airflow through the duct passes through the area between the light source and the light-sensitive element. The wavelength of the light emitted by the light source is selected such that the active ingredient vaporized into the gas phase by the heater has a high absorption cross-section at this wavelength specific to the active ingredient (e.g., in the IR or UV range). As the air enriched with the active ingredient flows through it, the photocell measures the absorption (attenuation) of the light emitted by the light source.The measured absorption value over time, in conjunction with the determination of the air volume flow through the air duct, is proportional to the amount of active ingredient evaporated into the air stream.

[0031] The signaling device can, for example, comprise one or more LEDs, a digital display, a screen, a haptic signal transmitter, and / or an acoustic signal transmitter. The electronic control device is configured to compare the measured values ​​of the sensor system, specifically the flow meter, with the at least one draft profile. If the result of the comparison is a deviation between the measured values ​​and the draft profile that exceeds a certain threshold, the electronic control device is configured to control the heating element and / or the signaling device in such a way that a predetermined reaction occurs depending on the specific deviation. A predetermined reaction can, for example, be an increase or decrease in the heating time of the heating element to change the vaporization, or a change in the pulse-pause ratio and thus the release of the active ingredient into the air / air-vapor volume flow.A predetermined response could, for example, be a signaling instruction to the user to adjust their inhalation. Alternatively, the user could be notified that an incorrect dose of the active ingredient has been administered.

[0032] Particularly for the application of the invention in the medical field, the inhalation profile can be determined in advance in an initialization procedure, for example, based on a series of inhalation puffs taken by a patient; that is, a user- or patient-specific inhalation profile is determined. The initialization procedure described below is not limited to medical applications but can also be used in non-medical applications, such as recreational applications.

[0033] Several inhalation puffs without drug delivery can be measured by vaporizing the medication at the heating element before actual use ("dry puffs"). It is also conceivable that one or more breaths of air can be taken, for example, to measure lung volume and / or function. Such measurements could be performed externally by a physician or with the inhaler itself. Externally recorded data can be transmitted via the inhaler's communication device (e.g., wirelessly based on Bluetooth, WLAN, RFID, ZigBee, optically, or via cable) to the electronic control unit and / or the data storage device.

[0034] By comparing the inhaler's performance with a theoretical puff profile, the patient's individual puff profile can be determined. This patient-specific puff profile is stored in the electronic memory. During actual use of the inhaler with drug delivery, the electronic control device compares this patient-specific puff profile with the measured values ​​of the current inhalation and reacts accordingly, as described above.

[0035] The patient-specific dosage profile can also take into account the amount of medication desired by the patient. This amount of medication can be specified, for example, by a doctor or pharmacist (e.g., based on a digital prescription) and transmitted to the electronic control device and / or data storage device via the aforementioned communication device.

[0036] Preferably, user data can be stored in the data storage device. For example, the frequency of use and / or the number of successful inhalations can be recorded depending on the date and time. By reading this data, a physician can monitor the correct (timing) use of the inhaler and administration of the active ingredient, adjust the patient's treatment plan if necessary, and consider the data in further diagnostics and therapy.

[0037] Furthermore, it is possible that the aforementioned user data and / or the train profile are stored in cloud storage via the communication device, either additionally or as an alternative to the data storage device. In this case, a doctor can remotely monitor the use of the inhaler by accessing the data in the cloud storage.

[0038] Preferably, stored data can be transferred to a mobile electronic device, such as a smartphone, laptop, smartwatch, or tablet, using the communication device. In this case, the user can monitor the use of the inhaler themselves using the mobile device. They can also set reminders on the mobile device if the inhaler is to be used at specific times or at recurring intervals.

[0039] For example, in clinical trials from Phase I onwards, the regular use of the inhaler can be advantageous, ensuring complete documentation of its application. Furthermore, when transferring data to a mobile device, users can record their personal sensations before and after using the inhaler. This allows for the detailed documentation of a causal relationship between specific physical reactions and the use of the inhaler or the medication administered with it. The information gained in this way, for example regarding the tolerability of a medication, can also be relevant for physicians when treating a disease with an already approved drug.

[0040] Controlled and reproducible drug delivery is a prerequisite for the use of the invention, or rather the inventive control of the heating current flowing through the heating element, in the field of medical applications. In other words, the present invention forms the basis for opening up a completely new field of application.

[0041] The invention thus solves the problem of a defined delivery of active ingredient or liquid per volume of air in a time-varying airflow.

[0042] The invention is explained below with reference to preferred embodiments and the accompanying figures.

[0043] This shows Fig. 1 a longitudinal section through an inhaler; Fig. 2 a schematic representation of an electronic arrangement of the inhaler with a sensor system; Fig. 3 a cross-section through a liquid tank with a centrally located internal air channel; Fig. 4 a flowchart for the use of an inhaler; and Fig. 5 a flowchart for the initialization of an inhaler.

[0044] The inhaler 10, here an electronic cigarette product, comprises a housing 11 in which an air channel 30 is provided between at least one air inlet opening 31 and an air outlet opening 24 at a mouthpiece 32 of the inhaler 10. When the user draws on the mouthpiece 32 for inhalation, the inhaler 10 is thereby subjected to a negative pressure and an airflow 34 is generated in the air channel 30.

[0045] The inhaler 10 advantageously comprises a liquid reservoir 18, an electrical energy storage device 14, and a vaporization device.

[0046] 20 with an electrical resistance heating element 21, an electrical arrangement 22 and a sensor system 33. The liquid reservoir 18 is advantageously arranged in a consumption unit 17 of the inhaler 10. The consumption unit 17 can advantageously be designed as a replaceable cartridge.

[0047] The electrical energy storage device 14 is advantageously arranged in a base part 16 of the inhaler 10. The energy storage device 14 can, in particular, be a disposable electrochemical battery or a rechargeable electrochemical battery, for example, a lithium-ion battery. Preferably, the energy storage device 14 is arranged in a part of the inhaler 10 located away from the mouthpiece 32. The delivery unit 17 is advantageously arranged between the energy storage device 14 and the mouthpiece 32.

[0048] The electrical arrangement 22 of the inhaler 10, which is in Figure 2As shown schematically, the electrical resistance heating element 21 comprises a digital electronic control device 15 and an electronic data storage device 35. The electronic control device 15 is a digital data processing device and preferably includes a microprocessor and / or a microcontroller. The electrical arrangement 22 may preferably include a communication device 13 and / or a signaling device 19. The communication device 13 is wireless, for example based on Bluetooth, WLAN, RFID, ZigBee, optical or wired, and is preferably configured for communication with a mobile electronic device, such as a mobile phone or smartphone, an external computer and / or a cloud storage device.The signaling device 19 comprises optical, acoustic and / or haptic signaling elements, for example one or more LEDs, a digital display, a display, a haptic signal transmitter and / or an acoustic signal transmitter.

[0049] Parts of the electrical arrangement 22 are preferably arranged in the base part 16, for example, control device 15, data storage 35, optionally communication device 13 and / or optionally signaling device 19. Parts of the electrical arrangement 22 can be arranged in the consumption unit 17, for example, the heating element 21. In other embodiments, the heating element 21 is arranged in the base part 16.

[0050] The air drawn in through the inlet opening 31 is guided in the air duct 30 to, through, or past the evaporation device 20. The evaporation device 20 is connected or connectable to the liquid reservoir 18, in which a liquid or liquid mixture is stored. The evaporation device 20 evaporates the liquid supplied to it from the liquid reservoir 18 and releases the evaporated liquid as an aerosol / vapor into the airflow 34.

[0051] The sensor system 33 advantageously comprises a pressure or flow switch 36 arranged in the air duct 30, or in flow connection thereto, which triggers, for example, when a predefined pressure threshold in the air duct 30 is undershot. Based on a signal issued by the pressure or flow switch 36, the control device 15 can detect that a consumer is drawing on the mouthpiece 32 of the cigarette product 10 to inhale. The flow measuring device 37 (see below) can perform the function of the flow switch 36, or a separate flow switch 36 may be provided. The control device 15 then controls the vaporization device 20 to add liquid from the liquid reservoir 18 as an aerosol / vapor to the airflow 34.

[0052] The liquid 50 stored in the liquid reservoir 18, which is to be dosed, is, for example, a mixture comprising one or more of the following components: 1,2-propylene glycol, glycerin, water, at least one flavor, optionally an active ingredient, for example nicotine.

[0053] The evaporation device 20 comprises at least one resistance heating element 21 and may include a wick element (not shown) for supplying liquid from the liquid reservoir 18 to the heating element 21. Due to its ohmic resistance, a current flowing through the electrically conductive heating element 21 causes it to heat up and therefore evaporates any liquid in contact with the heating element 21. The vapor / aerosol produced in this way escapes from the evaporation device 20 and is mixed with the airflow 34 (see figure). Figure 1The evaporation temperature, depending on the liquid to be evaporated, is preferably in the range between 100°C and 450°C, more preferably between 150°C and 350°C, and even more preferably between 190°C and 290°C.

[0054] The data storage device 35 is advantageously non-volatile and serves, for example, to store information or parameters relating to the consumption unit 17. The data storage device 35 can be part of the electronic control device 15. The data storage device 35 advantageously stores information on the composition of the liquid stored in the liquid reservoir 18, information on the evaporation profile, in particular on power / temperature control, data for condition monitoring or system testing, for example, leak testing, data relating to copy protection and anti-counterfeiting measures, an ID for the unique identification of the consumption unit 17, serial number, manufacturing date, expiry date, number of puffs (number of inhalations by the consumer), and / or usage time.

[0055] The sensor system 33 includes a flow measuring device 37, which is configured here as a differential pressure measuring device. The flow measuring device 37 includes a first pressure sensor 42 (see Figure 1 ), which is arranged to measure the atmospheric pressure outside the housing 11 of the inhaler 10. For example, a measuring port may be provided in the housing 11 to connect the first pressure sensor 42 to the atmosphere in a flow-conducting manner. The flow measuring device 37 further comprises a second pressure sensor 43 (see Figure 1), which is arranged to measure the air pressure prevailing in the air duct 30. The electronic control device 15 can calculate the air volume flow through the inhaler 10 by knowing the cross-section of the air duct at the measuring point of the second pressure sensor 43 and the pressure difference measured between the first and second pressure sensors 42, 43, and can determine a flow profile, i.e., the air volume flow over time, by repeatedly measuring the air volume.

[0056] The sensor system 33 includes a vapor quantity sensor 38 for measuring the quantity of liquid or vapor vaporized and released by the vaporization device 20 during an inhalation. The vapor quantity sensor 38 is, in this context, a humidity sensor. The vapor quantity sensor 38 includes a first humidity measuring element 40 (see Figure 1), which is located in the air duct 30 upstream of the heating element 21, for example in the area of ​​the air inlet opening 31. The steam quantity sensor 38 also has a second humidity measuring element 41 (see Figure 1 ), which is arranged in the air duct 30 downstream of the heating element, for example in or in the area of ​​the mouth section 32. With a known amount of water in the liquid to be evaporated and a calibration of the second humidity measuring element 41, the amount of liquid or vapor evaporated can be determined by the electronic control device 15 from the increase in humidity, i.e., the difference between the readings of the second humidity measuring element 41 and the first humidity measuring element 40.

[0057] The liquid tank 18 is preferably elongated with a centrally located internal air channel 30 ( Figure 3 shows a section perpendicular to the longitudinal axis L through the liquid tank 18). The in Figure 3For the sake of clarity, the evaporation device 20, which is not shown, evaporates the liquid supplied from the liquid tank 18 and releases it as vapor / aerosol to the airflow flowing through the internal air duct 30.

[0058] The sensor system 33 preferably includes a level sensor 39 for detecting the residual amount of liquid in the liquid tank 18 of the inhaler 10. The level sensor 39 is a capacitive sensor and has at least one pair of electrodes 44A, 45A; 44A, 45B; 44C, 45C (see Figure 3), which are arranged on opposite walls 46, 47 of the liquid tank 18. The electrodes 44A, 45A; 44A, 45B; 44C, 45C are preferably formed by metallized areas, in particular metallic (longitudinal) strips, which run continuously along the longitudinal axis of the liquid tank 18. Advantageously, at least one first electrode 44A, 44B, 44C is arranged on the, for example, cylindrical outer wall 46 of the liquid tank 18 and at least one second electrode 45A, 45B, 45C is arranged on the, for example, cylindrical inner wall 46 of the liquid tank 18 (and / or on the, for example, cylindrical outer wall of the air duct 30).

[0059] The level sensor 39 preferably has a plurality of electrode pairs, for example at least or exactly three electrode pairs 44A, 45A; 44A, 45B; 44C, 45C. The electrode pairs 44A, 45A; 44A, 45B; 44C, 45C are advantageously arranged at equal angular intervals, in Figure 3For example, at an angle of 120° to the central axis of the liquid tank 18, they are arranged alternately relative to each other. The first electrodes 44A, 44B, 44C and / or the second electrodes 45A, 45B, 45C can each be connected to form a continuous electrode 44 or 45, respectively.

[0060] Each electrode pair 44A, 45A; 44A, 45B; 44C, 45C forms a capacitor 46A, 46B, 46C with the (residual) liquid in the tank as a dielectric. The capacitance of each capacitor 46A, 46B, 46C is continuously measured. The measured capacitance of each capacitor 46A, 46B, 46C is proportional to the liquid level between the electrodes 44A, 45A; 44A, 45B; 44C, 45C. The arrangement and number of capacitors 46A, 46B, 46C allow the liquid level in the liquid tank 18 to be determined in any spatial orientation of the inhaler 10 or the cartridge or consumption unit 17.

[0061] The remaining amount of liquid in liquid tank 18 can be determined from the measured liquid level in the tank. Based on this remaining amount of liquid, a prediction can be made, for example, as to when a change of the consumption unit 17 (cartridge change) is likely to be necessary, based on the current user's previous usage profile.

[0062] The following describes a preferred method for controlling inhaler 10 based on the Figure 4 explained.

[0063] In step S1, the volume flow rate Q = dV / dt (see diagram on the right) of the airflow (or air / vapor flow) through the air duct 30 is measured over time using the flow meter 37. The volume flow rate Q is measured at the current time ta, and preferably the resulting inhalation profile Q(t) is measured over an entire inhalation. Plotting the volume flow rate Q over time t for an entire inhalation by the user yields an inhalation profile Q(t), as shown, for example, in the diagram on the right of step S1.

[0064] The electronic data storage device 35 of the inhaler 10 contains an ideal draft profile Qi(t), see diagram to the right of step S2.

[0065] In step S2, the electronic control device 15 performs a comparative analysis. This involves comparing the current volume flow rate Q(t=ta) measured in step S1 with a corresponding ideal value Qi(t=ta) derived from the stored draft profile Qi(t), and preferably comparing the draft profile Q(t) measured in step S1 (particularly during the period t0 corresponding to the start of the draft until ta) with the stored ideal draft profile Qi(t). The comparative analysis further includes determining any deviation of the current volume flow rate Q(t=ta) measured in step S1 from the corresponding ideal value Qi(t=ta), and preferably determining any deviation of the draft profile Q(t) measured in step S1 from the ideal draft profile Qi(t). In step S2, the measured current volume flow rate Q(t=ta) can be an instantaneous value corresponding to a single measurement, or a value averaged over a plurality of measurements Q(t=ta1), Q(t=ta2), ...

[0066] In the subsequent step S3, it is checked whether the current inhalation has ended. If the current inhalation has not ended (N), in step S4 it is checked whether the deviation of the measured current or instantaneous volume flow Q(t=ta) from the corresponding ideal value Qi(t=ta) determined in step S2 exceeds a threshold value stored in data memory 35.

[0067] If the current deviation considered in step S4 is above the stored threshold value (Y), in step S5 the active ingredient delivery into the airflow is adjusted, preferably based on the degree of the current deviation, by controlling the evaporation device 20, in particular by changing the heating current flowing through the heating element 21 and / or the heating duration of the heating element 21.

[0068] In addition or alternatively to step S5, step S6 can be used to indicate to the user the faulty or non-ideal current application of the inhaler 10 via at least one signal element of the signaling device 19 by the electronic control device 15, e.g. the indication of an incorrect amount of air and / or amount of active ingredient.

[0069] Following step S5 and / or S6, or if the current deviation considered in step S4 is below the stored threshold (N), step S2 is performed again. This feedback loop continues until step S3 determines that the inhalation is complete (Y).

[0070] Once it is determined in step S3 that the inhalation puff is complete (Y), in step S7 it is preferably checked whether a deviation of the puff profile Q(t) measured in step S1 from the ideal puff profile Qi(t), in each case over the entire inhalation puff (total deviation), is above a threshold value stored in the data memory 35.

[0071] If in step S7 it is determined that the total deviation is above the stored threshold value (Y), in step S8 a notification of the faulty or non-ideal use of the inhaler 10 to the user can be initiated by the electronic control device 15 via at least one signal element of the signaling device 19, e.g. the indication of an incorrect amount of air and / or amount of active ingredient via the inhalation in question.

[0072] In addition to or as an alternative to step S8, in step S9 the data from the comparative analysis of step S2 can be transmitted, for example via wireless communication, to a remote receiver 48, for example a cloud storage, for further analysis.

[0073] If in step S7 it is determined that the total deviation is below the stored threshold value (N), in step S9 the electronic control device 15 can indicate to the user the successful use of the inhaler 10 via at least one signal element of the signaling device 19, e.g. the indication of a correct amount of air and / or drug quantity for the relevant inhalation puff.

[0074] In addition or alternatively to step S9, in step S10 the data from the comparative analysis of step S2 can be transmitted, for example via wireless communication, to a remote receiver 48, for example a cloud storage, for further analysis.

[0075] An initialization procedure for the inhaler is described below using the following: Figure 5 explained.

[0076] In step S20, trajectory profiles are measured over several inhalation tranches, preferably without drug delivery, using the flow measuring device 37 and generated by the electronic control device 15.

[0077] In step S21, the electronic control device 15 performs a comparison of the measured train profiles with a theoretical train profile, which is advantageously stored in the data storage device 35.

[0078] In step S22, the electronic control device 15 performs a fitting (adjustment) of the theoretical train profile to the measured train profiles.

[0079] In step S23, the fitted train profile is stored as the ideal (user) train profile by the electronic control device 15 in the data storage device 35 in order to be available for comparisons or comparative analyses during the usage phase.

Claims

1. Inhaler (10) comprising a housing (11), an air channel (30) extending between at least one air inlet opening (32) and a suction opening (24) in the housing (11), a delivery element (21) for nebulizing or vaporizing liquid, supplied by the delivery element (21), for mixing with air flowing in the air channel, an electronic control device (15), an electronic data memory (35), and a sensor system (33) having a flow measuring device (37) for measuring the volume flow rate and / or mass flow rate of the airflow flowing through the air channel (30), the electronic control device (15) being configured to acquire a plurality of airflow measurements over at least part of the duration of an inhalation puff by means of the flow measuring device (37), to compare the plurality of airflow measurements with a puff profile stored in the data memory (35), and to output a control signal on the basis of the comparison of the plurality of airflow measurements with the stored puff profile, the puff profile being a defined ideal time profile of an air or air-vapor volume flow rate and / or mass flow rate that flows through the inhaler during at least part of or during the entire ideal inhalation puff of a user, characterized in that in the event of a defined deviation of the airflow measurements from the stored puff profile, the control signal triggers a suitable measure, the triggered measure being an adjustment of the actuation of the delivery element (21) for the amount of liquid to be vaporized or nebulized.

2. Inhaler (10) according to claim 1, characterized in that the triggered measure is - adjusting the actuation of the delivery element (21) for the amount of liquid to be vaporized or nebulized and - signaling relevant information to a user by means of a signaling apparatus (19).

3. Inhaler (10) according to either of the preceding claims, characterized in that the flow measuring device (37) is a differential pressure measuring device or a hot wire measuring device.

4. Inhaler (10) according to claim 3, characterized in that the differential pressure measuring device has a first pressure sensor (42) for measuring the atmospheric air pressure and a second pressure sensor (43) for measuring the air pressure prevailing in the air channel (30).

5. Inhaler (10) according to any of the preceding claims, characterized in that the sensor system (33) has a vapor amount sensor (38) for detecting the amount of liquid dispensed by a vaporization device (20) during an inhalation puff.

6. Inhaler according to claim 5, characterized in that the vapor amount sensor (38) is a humidity sensor.

7. Inhaler (10) according to claim 6, characterized in that the humidity sensor has a first humidity measuring element (40) arranged in the air channel upstream of the delivery element (21) and a second humidity measuring element (41) arranged in the air channel downstream of the delivery element.

8. Inhaler (10) according to claim 5, characterized in that the liquid amount sensor (38) is an optical absorption sensor.

9. Inhaler (10) according to any of claims 5 to 8, characterized in that the electronic control device (15) is configured to compensate for a changing water content in the liquid during the emptying of the liquid tank (18) by determining the residual amount of liquid in the liquid tank (18) by means of a level sensor (39) or by estimation by counting the puffs in conjunction with measuring the puff duration.

10. Inhaler (10) according to any of claims 5 to 9, characterized in that the electronic control device (15) is configured to calculate the amount of active ingredient vaporized from the determined amount of liquid vaporized.

11. Inhaler (10) according to any of the preceding claims, characterized in that the sensor system (33) has a level sensor (39) for detecting a residual amount of liquid in a liquid tank (17) of the inhaler (10).

12. Inhaler (10) according to claim 11, characterized in that that the level sensor (39) is a capacitive sensor.

13. Inhaler (10) according to claim 11 or 12, characterized in that the electronic control device (15) is configured to ascertain the duration until a cartridge change is required on the basis of the residual amount of liquid measured by means of the level sensor (39).

14. Inhaler (10) according to any of the preceding claims, characterized in that the electronic control device (15) is configured to carry out an initialization procedure prior to actual use comprising the following steps: - measuring a plurality of airflow measurements over one or more inhalation puffs by means of the flow measuring device (37); - comparing the airflow measurements with a theoretical puff profile stored, for example, in the data memory (35); - determining a user-specific ideal puff profile from the comparison of the airflow measurements with the theoretical puff profile; and - storing the user-specific ideal puff profile in the data memory (35).