Inhalation training device and system for practicing of an inhalation process of a patient

Abstract

An inhalation training device and inhalation training system for practicing of an inhalation process of a patient. The inhalation training device has a that is housing attachable to and detachable from a mouthpiece of an inhaler designed to provide a drug to the patient and a microphone adapted to measure the airflow occurring in the mouthpiece of the inhaler during an inhalation process of the patient. The inhalation training system includes the inhalation training device, an inhaler and an electronic device configured for evaluation of a signal received from the inhalation training device and for visual and/or audio feedback to the patient.

Claims

1. An inhalation training system for practicing of an inhalation process of a patient, the inhalation training system comprising: an inhalation training device; an inhaler constructed to provide a drug to the patient and having a mouthpiece at an outlet end thereof; and an electronic portable communications device configured for evaluation of an electronic signal received from the inhalation training device and for visual and audio feedback to the patient; wherein the inhalation training device comprises: a housing attachable to and detachable from the mouthpiece of the inhaler; a microphone adapted to directly measure sound produced by the airflow occurring in the mouthpiece of the inhaler during an inhalation process of the patient and from which said electronic signal is produced; and interface means for communicating the electronic signal to the electronic portable communications device, wherein the housing is constructed to prevent drug release during training by a finger-shaped blocking device covering an actuation element of the inhaler.

2. An inhalation training device for practicing of an inhalation process of a patient, the inhalation training device comprising a housing attachable to and detachable from a mouthpiece of an inhaler constructed to provide a drug to the patient, wherein the housing has a finger-shaped blocking device covering an actuation element of the inhaler in a manner acting to prevent drug release during an inhalation process of the patient, and wherein the inhalation training device comprises a microphone adapted to directly measure sound produced by the airflow occurring in the mouthpiece of the inhaler during an inhalation process of the patient, and wherein the microphone is positioned at a location in the inhalation training device that will be adjacent to an air-vent or nozzle of the mouthpiece of the inhaler, when the housing of the inhalation training device is attached to the mouthpiece of the inhaler, and removed from the inhaler, when the housing of the inhalation training device is detached from the mouthpiece of the inhaler.

3. The inhalation training device according to claim 2, wherein the housing comprises at least one of a pad and a sleeve around the microphone that is made of foam plastic or soft silicone.

4. The inhalation training device according to claim 2, wherein the microphone is adapted to measure the noise of the airflow through the air-vent or nozzle of the mouthpiece of the inhaler.

5. The inhalation training device according to claim 2, wherein the microphone is a directional or bi-directional microphone.

6. The inhalation training device according to claim 2, wherein the microphone is adapted to produce an electronic signal and the inhalation training device has an interface for communicating the electronic signal to an electronic portable communications device.

7. The inhalation training device according to claim 6, wherein the interface comprises a TRRS headset connector and wherein the inhalation training device comprises electronics configured to swap the electric connection to the microphone and to ground in dependence of a connection scheme of the TRRS headset connector.

8. The inhalation training device according to claim 6, wherein the inhalation training device comprises electronics configured to adjust a frequency range in which the microphone operates as a function of an analog front-end sensitivity of the electronic portable communications device.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 schematically shows a perspective view of a preferred embodiment of an inhalation training device according to the present invention, in a state prior to its final assembly and together with a smartphone;

(2) FIG. 2 schematically shows a section through a housing of the inhalation training device after final assembly of the housing;

(3) FIG. 3 schematically shows a section through an inhaler with the inhalation training device attached to a mouthpiece of the inhaler which is in a relaxed state;

(4) FIG. 4 schematically shows the inhaler of FIG. 3 axially rotated about 90? in a tensioned state; and

(5) FIG. 5 schematically shows a perspective view of an inhalation training system according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

(6) In the figures, the same reference numbers are used for the same or similar parts, corresponding properties and advantages being achieved even if a repeated description is omitted.

(7) FIG. 1 schematically shows a perspective view of a preferred embodiment of an inhalation training device 1 according to the present invention in a state prior to its final assembly.

(8) The inhalation training device 1 is or can be used for practicing an inhalation process of a patient who is not shown.

(9) The inhalation training device 1 comprises a housing 2 attachable to and preferably detachable from a mouthpiece 3 or any other component of an inhaler 4, in particular a so-called RESPIMAT? inhaler as shown, e.g., in WO 2008/151796 A1 and corresponding U.S. Patent Application Publication 2008/0314380. The inhaler 4 is designed to provide a drug to a patient.

(10) In the preferred embodiment, the inhalation training device 1 only works in combination with a specified or definite inhaler 4, such as the RESPIMAT? inhaler 4. In particular, the inhalation training device 1 only works as intended when mounted over or to the inhaler 4, in particular its mouthpiece 3.

(11) The inhalation training device 1 comprises a microphone 5 adapted to measure the airflow occurring in or into the mouthpiece 3 during an inhalation process of the patient.

(12) In the preferred embodiment, the microphone 5 is an electret microphone.

(13) Preferably, the inhalation training device 1 or microphone 5 is adapted to measure the noise of the airflow through an air-vent, such as an opening 34 shown in FIG. 3, of the inhaler 4 or the mouthpiece 3.

(14) Preferably, the housing 2 of the inhalation training device 1 comprises or consists of two housing parts 2a, 2b, preferably a lower housing part 2a and an upper housing part 2b.

(15) Preferably the housing 2 or lower housing part 2a has a holding or cylindrical section 2aa, which has preferably the shape of a hollow oblique cylinder with an elliptic base. The shape of the section 2aa is preferably similar or adapted to the shape of the mouthpiece 3 of the inhaler 4, preferably so that the section 2aa can be pushed onto the mouthpiece 3.

(16) In particular, the circumference of the cylindrical section 2aa of the lower housing part 2a is greater than the circumference of the mouthpiece 3 of the inhaler 4.

(17) The section 2aa or lower housing part 2a comprises preferably an outward or essentially radial protrusion 2ab.

(18) The lower housing part 2a preferably comprises a finger or cover 2ac protruding from or connected to the cylindrical section 2aa. Preferably, the finger 2ac is spaced from the protrusion 2ab of the lower housing part 2a along the circumference of the cylindrical section 2aa.

(19) The upper housing part 2b comprises preferably a cylindrical section 2ba, which has preferably the shape of a hollow oblique cylinder with an elliptic base. The circumference of the cylindrical section 2ba of the upper housing part 2b is preferably greater than the circumference of the cylindrical section 2aa of the lower housing part 2a. The height of the cylindrical section 2ba of the upper housing part 2b is preferably smaller than the height of the cylindrical section 2aa of the lower housing part 2a. The cylindrical section 2ba of the upper housing part 2b comprises preferably an outward protrusion 2bb. The upper housing part 2b comprises preferably a finger or cover 2bc. Preferably, the finger or cover 2bc protrudes from the cylindrical section 2ba of the upper housing part 2b and/or is spaced from the protrusion 2bb of the upper housing part 2b along the circumference of the cylindrical section 2ba of the upper housing part 2b.

(20) During assembly of the housing 2, the microphone 5 is mounted in the protrusion 2ac of the lower housing part 2a and an audio cable 6 connected to the microphone 5 is lead out of the protrusion 2ac of the lower housing part 2a alongside the cylindrical section 2aa and the cover 2ac of the lower housing part 2a. Furthermore, the upper housing part 2b is put over the lower housing part 2a and both housing parts 2a, 2b are snap-clicked together such that the cylindrical section 2ba of the upper housing part 2b surrounds the cylindrical section 2aa of the lower housing part 2a and that the protrusion 2bb of the upper housing part 2b covers the protrusion 2ab of the lower housing part 2a and that the cover 2bc of the upper housing part 2b covers the cover 2ac of the lower housing part 2a.

(21) Preferably, the housing parts 2a and 2b are connected with each other by snap-fit and/or form-fit.

(22) Preferably, the housing 2 holds or receives the microphone 5 and/or an associated cable 6.

(23) Preferably, the microphone 5 is received between the housing parts 2a and 2b.

(24) Preferably, the cable 6 is received and/or guided between the housing parts 2a and 2b and/or the sections 2ac and 2bc.

(25) The inhalation training device 1 or housing 2 comprises preferably a blocking device 2c for blocking actuation of the inhaler 4. Preferably, the blocking device 2c is formed by the section 2ac and/or 2bc.

(26) Preferably, the blocking device 2c is formed or realized as a finger covering a blocking element 15 of the inhaler 4 as schematically shown in FIGS. 4 and 5.

(27) Preferably, the blocking device 2c and/or sections 2ac, 2bc extend at least partially in axial direction and/or parallel to a longitudinal direction of the inhaler 4 and/or to a longitudinal axis of the housing 2 or holding section 2aa.

(28) The holding section 2aa is adapted to mount the inhalation training device 1 or its housing 2 to the associated inhaler 4, in particular to its mouthpiece 3 or any other component. Most preferably, the section 2aa allows a mechanical connection by press-fit to the mouthpiece 3 or the like.

(29) Preferably, the outer contour of the mouthpiece 3 and the inner contour of the section 2aa are slightly tapered towards the free end and adapted so that the desired clamping can be achieved when the section 2aa is pushed onto the mouthpiece 3. However, other forms and/or constructional solutions are possible.

(30) FIG. 2 schematically shows a section through the housing 2 of the inhalation training device 1 after final assembly of the housing 2, but without microphone 5, cable 6, and the like.

(31) Both housing parts 2a, 2b are made preferably of molded plastic with a smoothed surface. Thus, handling noise caused by the patient practicing an inhalation process, e.g., by sliding or scratching with his fingers over the inhalation training device 1, is reduced. Therefore, measurement accuracy is increased.

(32) The inhalation training device 1 provides an interface and/or is connectable to an electronic device 7. In the preferred embodiment of FIG. 1, the electronic device 7 is a smartphone.

(33) In the preferred embodiment, the interface and/or connection to the electric device 7 is realized preferably by means of cable 6 and/or a connector 8, such as an audio jack, in particular a 3.5 mm TRRS headset connector or the like.

(34) As the 3.5 mm TRRS headset connector 8 is the globally most common connector for smartphones, the inhalation training device 1 is preferably compatible to a wide range of smartphones and is required only in one variant. This enables a comfortable and cost-efficient training of an inhalation process of a patient and a patient-friendly real-time feedback.

(35) Additionally or alternatively, the inhalation training device 1 can be connected with the electric device 7 wireless, e.g., via Bluetooth.

(36) In the preferred embodiment, the inhalation training device 1 comprises electronics 5a (indicated in FIGS. 1 and 3) configured to process any microphone signal and/or to generate a reference tone during training. Thus, the reference tone accompanies the signal of the microphone 5 at all times and makes available a known reference. In particular, this reference tone is realized preferably by implementing a precise oscillator of a well-defined frequency of about 10 kHz and an amplitude of preferably 1.2 V into the electronics 5a of the inhalation training device 1 and mixing the reference tone into the microphone signal.

(37) FIG. 3 schematically shows a section through the inhaler 4 with the inhalation training device 1 attached to the mouthpiece 3 of the inhaler 4. FIG. 4 schematically shows also a section through the inhaler 4 with the inhalation training device 1 attached to the mouthpiece 3 of the inhaler 4, whereas the inhaler 4 and the attached inhalation training device 1 are axially rotated about 90?.

(38) The two housing parts 2a, 2b are designed preferably to exactly fit together and to firmly fit over the mouthpiece 3 of the inhaler 4. This ensures minimal leakage between the mouthpiece 3 of the inhaler 4 and the housing 2 of the inhalation training device 1. Thus, high measurement accuracy and high mechanical stability is achieved. At the same time, the housing 2 has adequate space inside to contain and protect the microphone 5, audio cable 6 and further electronics 5a.

(39) Furthermore, the described design of the housing 2, in particular non-circular cross-section of the section 2aa and the mouthpiece 3, prevents wrong positioning of the housing 2 when being attached to the mouthpiece 3 of the inhaler 4.

(40) In the illustrated and preferred embodiment, the housing 2 is designed such that drug release during training is prevented. In particular, the blocking device 2c or covers 2ac, 2bc of the two housing parts 2a, 2b cover a drug release actuator, such as blocking element 15, of the inhaler 4 when the inhalation training device 1 is attached to the mouthpiece 3 of the inhaler 4.

(41) When the inhalation training device 1 is attached to the mouthpiece 3 of the inhaler 4, the microphone 5 is positioned preferably automatically, outside the mouthpiece 3 of the inhaler 4 and/or near an air-vent or opening 34 of the mouthpiece 3 of the inhaler 4. This enables a precise flow measurement without any need of intervention within the function of the inhaler 4 or fluid flow in the mouthpiece 3 and without the need of changing the design of the inhaler 4. Preferably, the aerodynamic behavior of the flow path of the inhaler 4 is not changed by the inhalation training device 1. In that manner, the medical compliance of the inhaler 4 is not affected by the presence (or absence) of the inhalation training device 1.

(42) Measurements were taken using calibrated TetraTec flow measuring equipment (TetraTec Instruments GmbH, 71144 Steinenbronn, Germany) and comparison was made using a stand-alone inhaler 4 and then the same inhaler 4 where the inhalation training device 1 was mounted over the mouthpiece 3 of the inhaler 4. In both situations the flow resistance was measured for a tube connected to the mouthpiece 3 (not covering the air vents). Measurements showed that airflow is not restricted by the presence of the inhalation training device 1. The flow resistance when using the inhalation training device 1 is unchanged compared to the stand-alone inhaler 4 thereby supporting the requirements to not train patients with another type of inhalation experience.

(43) In the following, the inhaler 4 is described in more detail.

(44) The inhaler 4 is designed to atomize a fluid 9, particularly a highly effective pharmaceutical composition, medicament or the like, diagrammatically shown in a relaxed state (FIG. 3) and in a tensioned state (FIG. 4). The inhaler 4 is constructed, in particular, as a portable inhaler and preferably operates only mechanical and/or without propellant gas.

(45) The inhaler 4 is provided with or comprises an insertable or replaceable container 10 containing the fluid 9. The container 10 thus forms a reservoir for the fluid 9, which is to be nebulized. Preferably, the container 10 contains multiple doses of fluid 9 or active substance in particular sufficient to provide up to 200 dosage units or doses, for example, i.e., to allow up to 200 sprays or applications. A typical container 10, as disclosed in WO 96/06011 A1 and corresponding U.S. Pat. No. 5,833,088, holds, e.g., a volume of about 2 to 20 ml.

(46) It is noted that the dose can vary, in particular depending on the fluid 9 or medicament. The inhaler 4 can be adapted respectively.

(47) Further, the number of doses contained in the container 10 and/or the total volume of the fluid 9 contained in the container 10 can vary depending on the fluid 9 or respective medicament and/or depending on the container 10 and/or depending on the necessary medication or the like.

(48) Preferably, the container 10 can be replaced or exchanged, wherein the number of containers 10, which can be used with the same inhaler 4, is preferably restricted, e.g., to a total number of four or five containers 10.

(49) The container 10 is preferably substantially cylindrical or cartridge-shaped and once the inhaler 4 has been opened the container 10 can be inserted therein preferably from below and changed if desired. It is preferably of rigid construction, the fluid 9 in particular being held in a collapsible bag 11 in the container 10. In particular, the container 10 comprises a venting opening or hole 30 which is opened before or during first use.

(50) The inhaler 4 comprises a delivery mechanism, preferably a pressure generator 12, for conveying and nebulizing the fluid 9, particularly in a preset and optionally in an adjustable dosage amount.

(51) The inhaler 4 or pressure generator 12 comprises preferably a holder 13 for releasably holding the container 10, a drive spring 14 associated to the holder 13, only partly shown, and/or a blocking element 15 preferably in form of or with a button for preferably manual actuation or depressing. The blocking element 15 can catch and block the holder 13 and can be manually operated to release the holder 13 allowing drive spring 14 to expand.

(52) The inhaler 4 or pressure generator 12 comprises preferably a conveying element, such as a conveying tube 16, a non-return valve 17, a pressure chamber 18 and/or a nozzle 19 for nebulizing the fluid 9 into the mouthpiece 3.

(53) The completely inserted container 10 is fixed or held in the inhaler 4 via the holder 13 such that the conveying element fluidically connects the container 10 to the inhaler 4 or pressure generator 12. Preferably, the conveying tube 16 penetrates into the container 10.

(54) The inhaler 4 or holder 13 is preferably constructed so that the container 10 can be exchanged.

(55) When the drive spring 14 is axially tensioned in the tensioning process, the holder 13 with the container 10 and the conveying tube 16 are moved downwards in the drawings and fluid 9 is sucked out of the container 10 into the pressure chamber 18 of the pressure generator 12 through the non-return valve 17. In this state, the holder 13 is caught by the blocking element 15 so that the drive spring 14 is kept compressed. Then, the inhaler 4 is in the tensioned state.

(56) If actuation or pressing of the blocking element 15 was possible (which is not the case when the inhalation training device 1 is attached to the inhaler 4) a relaxation would follow in the nebulization process, during which the fluid 9 in the pressure chamber 18 would be put under pressure as the conveying tube 16 with its then closed non-return valve 17 would be moved back in the pressure chamber 18, here in the drawings upwards, by the relaxation or force of the drive spring 14 and then would act as a pressing ram or piston. This pressure would force the fluid 9 through the nozzle 19, whereupon it would be nebulized into an aerosol and, thus, dispensed.

(57) Generally, the inhaler 4 operates with a spring pressure of 5 to 200 MPa, preferably 10 to 100 MPa on the fluid 2, and/or with a volume of fluid 2 delivered per stroke of 10 to 50 preferably 10 to 20 ?l, most preferably about 15 ?l. The fluid 9 is converted into or nebulized as aerosol, the droplets of which have an aerodynamic diameter of up to 20 ?m, preferably 3 to 10 ?m. Preferably, the generated jet spray has an angle of 20? to 160?, preferably 80? to 100?.

(58) The inhaler 4 comprises preferably a housing 31 and/or (upper) housing part 23 and optionally a biasing or inner part 24 preferably which is rotatable relative thereto (FIG. 4) and/or has an upper part 24a and a lower part 24b (FIG. 3).

(59) The inhaler 4 or housing 31 comprises preferably a (lower) housing part 25. This part 25 is in particular manually operable, and/or releasable fixed, particularly fitted or held onto the inner part 24, preferably by means of a retaining element 26.

(60) Preferably, the housing parts 23 and 25 and/or other parts form the housing 31 of the inhaler 4.

(61) In order to insert and/or replace the container 10, preferably the housing 31 can be opened and/or the housing part 25 can be detached from the inhaler 4, inner part 24 or housing 31.

(62) Generally and preferably, the container 10 can be inserted before the housing 31 is closed and/or before the housing part 25 is connected to the housing 31. Preferably, the container 10 is inserted, opened and/or fluidically connected to the delivery mechanism automatically or simultaneously when (completely) connecting the housing part 25 to the housing 31/inhaler 4 and/or when (completely) closing the housing 31/inhaler 4.

(63) Preferably, the inhaler 4 or drive spring 14 can be manually activated or tensioned, in particular by actuation of an actuation member, here preferably by rotating housing part 25 or any other component.

(64) The actuation member, preferably the housing part 25, can be actuated, here rotated relative to the upper housing part 23, carrying with it or driving the inner part 24. The inner part 24 acts on a gear or transmission to transform the rotation in an axial movement. As a result, the drive spring 14 is tensioned in the axial direction by means of the gear or transmission (not shown) formed between the inner part 24, in particular its upper part 24a, and the holder 13 and acting on the holder 13. During tensioning the container 10 is moved axially downwards until the container 10 assumes an end position as shown in FIG. 4. In this activated or tensioned state the drive spring 14 is under tension and can be caught or held by the blocking element 15. During the nebulizing process the container 10 is moved back into its original position (non-tensioned position or state shown in FIG. 3) by (the force of) the drive spring 14. Thus, the container 10 executes a lifting or stroke movement during the tensioning process and during the nebulizing process.

(65) The housing part 25 preferably forms a cap-like lower housing part and/or fits around or over a lower free end portion of the container 10. As the drive spring 14 is tensioned the container 10 moves with its end portion (further) into the housing part 25 or towards the end face thereof, while an aeration means, such as an axially acting spring 27 arranged in the housing part 25, comes in contact with base 28 of the container 10 and pierces the container 3 or a base seal or foil 50 thereon with a piercing element 22 when the container 3 makes contact with it for the first time, to allow air in or aeration, preferably by opening or piercing venting hole 23.

(66) The inhaler 4 comprises preferably an indicator device 25, which counts in particular actuations of the inhaler 4, preferably by detecting tensioning of the drive spring 14 or the rotation of the inner part 24 relative to the upper part 23 or housing 31. Preferably, the counter device 32 or an associated locking device 33 locks the inhaler 4 against (further) actuation or use, e.g., blocks further rotation of the housing part 25/inner part 24 and, thus, tensioning of the inhaler 4 or its drive spring 14 and/or blocks actuation of the blocking element 15, in a locked state when a certain number of actuations or operations or discharged doses has been reached or exceeded.

(67) Unlike freestanding equipment or the like, the inhaler 4 is preferably designed to be portable, and in particular, is a portable hand operated device.

(68) Preferably, the fluid 9 is an aqueous pharmaceutical formulation or an ethanolic pharmaceutical formulation. However, it may also be some other pharmaceutical formulation, a suspension or the like.

(69) Alternatively, the fluid 9 may also comprise particles or powder. In this case, instead of the expulsion nozzle 17, some other kind of supply device may be provided, especially an expulsion opening (not shown) or a supply channel (not shown) for supplying the fluid to or powder or the like into the mouthpiece 3. An optional air supply opening (not shown) then serves to supply ambient air preferably in parallel so as to generate or allow an airflow with a sufficient volume for breathing in or inhaling through the mouthpiece 3.

(70) If necessary, the fluid 9 may also be atomized by means of a propellant gas.

(71) Preferred ingredients and/or formulations of the preferably medicinal fluid 9 are listed in particular in WO 2009/115200 A1, preferably on pages 25 to 40, and in corresponding U.S. Pat. No. 8,650,840, or in EP 2 614 848 A1, paragraphs [0040] to [0087], which are incorporated herein by reference. In particular, these fluids may be aqueous or non-aqueous solutions, mixtures, formulations containing ethanol or free from any solvent, or the like.

(72) FIG. 5 schematically shows a perspective view of a preferred embodiment of an inhalation training system 35 according to the present invention.

(73) The inhalation training system 35 is used or usable or designed for practicing of an inhalation process of a patient.

(74) The inhalation training system 35 comprises the inhalation training device 1 as described above, an inhaler 4 preferably as described above, and a separate and/or mobile electronic device 7, preferably a smartphone.

(75) The smartphone 7 is configured for evaluation of a signal received from the inhalation training device 1 and for visual and/or audio feedback to the patient, in particular via a display 7a, a loud speaker 7b or the like.

(76) The purpose of the inhalation training system 35 is to further educate the patient to inhale correctly with the range of inhalers. Due to the preferred soft mist technology of the inhalers which generate a homogeneous droplet aerosol cloud of 1 to 1.5 seconds duration and where the instructions for correct inhalation is to inhale with relative low flow over an extended period of time, some patients may potentially be confused on correct use as they previously might have been subjected to other inhalers specifically requiring them to inhale forcefully and with only very short duration (e.g., passive dry powder inhalers).

(77) The inhalation training system 35 enables an effective, simple, reliable, comfortable and cost-efficient training of an inhalation process of a patient and a precise measurement of a flow generated by the patient during training and a patient-friendly real-time feedback.

(78) In the preferred embodiment, the inhalation training system 35 is configured to non-invasive detection (i.e., with unchanged flow resistance of the inhaler 4) of correct inhalation flow in the range of at least 20 to 40 l/min with an accuracy of at least +/?50% but preferably better than +/?20%.

(79) The electronic device 7 is configured preferably to detect the presence of the inhalation training device 1 by means of the reference tone generated by the inhalation training device 1 during training as described above. Thus, the electronic device 7 can detect if an inhalation training device 1 has been plugged via connector 8 into the electronic device 7. The electronic device 7 is configured to not provide any feedback related to flow detection if this is not the case.

(80) The electronic device 7 is capable of interfacing to the external microphone 5 of the inhalation training device 1.

(81) In the preferred embodiment, the electronic device 7 is equipped with a dedicated App which in combination is capable of real-time measuring and displaying information (preferably via display 7a) related to patient inhalation flow thereby providing feedback regarding correct and incorrect inhalation techniques.

(82) The App presents flow feedback to the patient in a simple and intuitive manner (non-scientific) and is available for download onto the electronic device 7. For this purpose, the App is developed for all main platforms, especially iOS and Android.

(83) Even if the App has been developed to contain all technical analysis capabilities as presented above, the App is targeted at a very broad audience of patients and hence leverages a very simple and intuitive user interface. Preferably, the App and/or electronic device 7 are adapted to give an audible and/or visible feedback, preferably via the display 7a of the electronic device 7 and/or most preferably by showing one or more respective symbols 7, such as a balloon or the like, which can be easily understood by most people (compare FIG. 5 which shows as an example a balloon as symbol 7d for indicating the inhalation process or the like).

(84) In particular, a balloon concept was finally chosen as the core element to provide feedback regarding patient inhalation flow pattern. According to this concept, the patient's inhalation flow rate determines the balloon flight level. If the patent performs a forceful inhalation (e.g., more than 60 l/min) the balloon will fly high on the screen, whereas a very weak inhalation (e.g., less than 10 l/min) will result in the balloon hovering at the bottom of the screen. In the center range of 20-40 l/min the balloon shifts color from red (amber) to green and two sharp arrows start to close in from the sides. After two seconds of correct flow rate the arrows puncture the balloon thereby indicating a successful inhalation. When the balloon pops the screen turns to a 10 seconds countdown clock allowing training of breath holding following inhalation (similar to the use instructions).

(85) The App is split in two parts, a passive guide part and an active training part, and the patient is carefully introduced to the guide before being subject to real training.

(86) The patient initially accept the terms of use and then enters into the guide part of the App where he is carried through all patient related installation steps of mounting the inhalation training device 1 over the mouthpiece 3 of the inhaler 4 and plugging the connector 8 into the electronic device 7. The patient is introduced to the features of the App using animated screens of both balloon flying and breath holding. At any point in the guide the patient may press a highlighted X to exit the guide and begin training, otherwise he will on the very last guide page be redirected to the training part of the App by simple button confirmation to Start training. When entering the training part the App requires the presence of the inhalation training device 1 to function. If the inhalation training device 1 is not mounted then a warning will be presented to the patient.

(87) Generally, the user or patient could also press a button 7c, the touch screen or the like of the electronic device 7 for input or confirmation purposes.

(88) Then, the flow training takes place by inhaling through the inhalation training device 1 mounted over the inhaler 4 and completing the quest to balance the balloon in the green zone for two seconds and following to hold the breath for 10 seconds. After successfully having completed both steps, the green colored symbol will fly into a history bar showing the last five attempts. Since the App has no means to detect the patient holding his/her breath, the last step in this training sequence will never be able to disqualify an otherwise perfect inhalation sequence only the final result adding to the history awaits the 10 seconds delay.

(89) Since the primary training objective of the inhalation training device 1 is to help patients reduce inhalation flow to a much lower level than, e.g., required with a passive DPI the one element that can cause an unsuccessful inhalation is if the patient inhales too strongly (above 40 l/min) for two seconds (or longer). In this situation the inhalation sequence will be unsuccessful and the negative result will be added directly to the history without going through the sequence of breath holding.

(90) After every test completion, successful or unsuccessful, the patient is presented with the option to Try again to motivate him/her to continue training until he/she safely and reliably can balance the balloon right every time (at least for five consecutive trials).

(91) Instructions are preferably stored on an information storage medium and when executed by a processor cause the execution of the steps described above.

(92) Other steps can be added to the described steps of the App. Individual steps of the App can also be omitted. The sequence of the individual steps can be changed and different steps can be combined with one another. Individual steps of the App can also be implemented independently of other steps.

(93) Flow measurement accuracy also depends on the production tolerances of the microphone 5 which potentially could exhibit +/?3 dB variation in acoustic sensitivity. If no other sources to error did exist such microphone tolerance variation would translate to a measuring uncertainty around +/?35%. This uncertainty does not appear to be critical to perform the inhalation training process where e.g., a measuring uncertainty of +/?50% has been communicated being acceptable.

(94) To mitigate the microphone tolerance variation, the microphone gain and/or the reference tone amplitude can be calibrated. Preferably, each electronics module including the microphone 5 is subjected (prior to mounting in the housing 2 of the inhalation training device 1) to a test using a reference acoustic signal allowing assessment of variation from ideal reference. In case of deviations, e.g., the reference tone amplitude is adjusted to produce the desired relation to the measured microphone signal. Adjustment could be as simple as cutting a wire on the carrying flexible printed circuitry board (cutting, e.g., a parallel resistor controlling reference voltage attenuation).

(95) Alternatively, the final assembled inhalation training device 1 could be tested to create a code based on the individual acoustic deviation. The code can then be imported into the App prior to use. For example, the inhalation training device 1 can have an individual serial number containing a single digit reference to categorize the inhalation training device 1. In order to improve measuring accuracy the patient can manually enter the code upon start of the App. Alternatively, a barcode can be printed on the housing 2 of the inhalation training device 1. The patient can then scan the barcode with a camera of the smartphone 7 during the initialization procedure of the App.

(96) FIG. 5 shows another preferred aspect of the present invention. Preferably, the inhalation training device or its housing 2 comprises the blocking device 2c for blocking any dispensing of fluid 9 by the inhaler 4 when the inhalation training device 1 is mounted to or with the inhaler 4. Preferably, the blocking device 2c covers an actuation element or button, such as blocking element 15 of the inhaler 4 in order to block or prevent any possible actuation and, thus, any possible dispensing of fluid 9. However, other construction solutions are possible as well.

(97) Preferably, the inhalation training device 1 does not (significantly) amend or restrict the flow of air which is drawn through the at least one opening 34 into the mouthpiece 3 during inhalation. However, the microphone 5 might protrude into an associated opening 34 and/or is preferably located adjacent, most preferably as near as possible, to one venting opening 34.

(98) In the embodiment, the inhalation training device 1 or its housing 2 does not cover the other opening 34. For this purpose, the inhalation training device 1 or housing 2 comprises preferably a recess 2d as indicated in FIGS. 1 to 3.

(99) In order to not restrict flow of air that is sucked through opening(s) 34 into the mouthpiece 3 during inhalation, the inhalation training device 1 or its housing 2 comprises preferably at least one supply opening 2e or the like as schematically shown in FIGS. 1 and 3.

(100) Preferably, the cable 6 is guided within the inhalation training device 1 or its housing 2 from the mouthpiece 3 towards the other end of the inhaler 4, preferably through the blocking device 2c and/or preferably thinner like portions or sections 2ac and/or 2bc.

(101) Preferably, the microphone 5 and electronics 5a form a unit or assembly. In particular, the electronics 5a is integrated into the microphone 5 or vice versa.

(102) Preferably, the training inhalation device 1 or its housing 2 holds the unit or assembly of microphone 5 and/or electronics 5a by snap-fit and/or form-fit. A possible realization is indicated in FIG. 3 schematically. For example, the unit or assembly can be inserted into or through a holding recess 2f or the like or mounted, with the microphone 5 preferably pointing towards the mouthpiece 3, adjacent to air vent opening 34 and/or adjacent to the nozzle 19 of the inhaler 4 and/or pointing radially inwards.

(103) Preferably, the blocking device 2c is supported or abuts against the inhaler housing 31, preferably an upper housing part 23 of the inhaler 4. For this purpose, the blocking device 2c or section 2ac may comprise a respective protrusion or contact portion 2ca as indicated in FIGS. 4 and 5.

(104) Preferably, the blocking device 2c covers the blocking element 15 or any other actuation element, necessary for triggering or initiating dispensing of fluid 9 from the nebulizer 4, preferably completely, such that any dispensing of fluid 9 from the inhaler 4 is securely prevented when the inhalation training device 1 is mounted to the inhaler 4 or vice versa.