Powder Inhaler Assembly

Abstract

The powder inhaler assembly comprises a powder inhaler (2) having a metering device (10) having a dosing recess (11) and movable relative to the container (8) and the inhalation channel (9) between an idle state in which the dosing recess (11) is in communication with an opening (12) of the container (8) so as to be filled with a dose of powdered medicament, and a triggered state in which the dosing recess (11) is in communication with the inhalation channel (9) to enable inhalation of a dose of powdered medicament contained in the dosing recess (11) through the mouthpiece (6). An electronics module (3) is attachable to the powder inhaler (2) and comprises a non-contact sensor (29) arranged and configured to sense the position of at least a portion of the metering device (10) to at least detect when the metering device (10) is in the triggered state.

Description

[Technical field]

[0001] The present invention relates to a powder inhaler assembly, i.e. a device for delivering a powdered drug formulation by inhalation. The device is in particular a portable, propellant-free, multi-dose, breath-activated dry powder inhaler equipped with a metering device for delivering doses from a drug container. The device is in particular a portable, multi-dose dry powder inhaler equipped with a removable electronic module configured to detect activation of the metering device, and possibly other related functions. [Background technology]

[0002] The administration of powdered pharmaceutical formulations by inhalation from an inhaler is generally known. Multi-dose powder inhalers are also known which comprise a powder container and a metering member for metering and delivering unit doses.

[0003] The same applicant's document WO 2004 / 012801 discloses a powder inhaler comprising a container for storing a powdered medicament, a metering member having a dosing recess into which a dose of the powdered medicament is filled, and a mouthpiece in communication with the inhalation channel of the powder inhaler. The powder inhaler comprises a protective member slidably movable on the metering member between a closed position, in which the protective member covers the dosing recess of the metering member when the metering member is in the inhalation position, and an open position, in which the protective member exposes the dosing recess, thereby allowing inhalation of a dose of powdered medicament contained in the dosing recess. The protective member is coupled to an inhalation actuated mechanism such that the inhalation actuated mechanism moves the protective member from its closed position to its open position when there is an inhalation suction force exerted by the user that exceeds a predetermined level.

[0004] The mechanical structure of the powder inhaler of WO 2004 / 012801 can provide a powder inhaler with improved dosing functionality, thereby avoiding unintentional dosing. Nowadays, every user owns an electronic device, such as a computer, a smartphone or a tablet, that has applications that can be used in daily life and that can be useful for managing the administration of medicines.

[0005] WO 2016 / 000983, a document by the same applicant, discloses a powder inhaler similar to that of WO 2004 / 012801.

[0006] The powder inhalers of WO 2004 / 012801 and WO 2016 / 000983 do not include any electronic devices for interfacing with external electronic devices.

[0007] Inhalers are also known which are provided with electronic devices arranged to detect actuation of the inhaler itself and / or to collect data.

[0008] The document US6182655 discloses an inhaler for multiple dose administration of pharmacological dry powder, which externally consists of a housing and a protective cap that can be removed from the mouthpiece attached to the housing. A slide rail, a dosing slide, a shutter, a carriage, a funnel device, a counter device, a valve shield and a valve guide are arranged inside. Dosing is initiated by removal of the protective cap, and the dose received in the dosing cavity is transported by the dosing slide to the mouthpiece. The inhaler can be supplemented with a plug-in reusable electronic module and a controllable nozzle so that data related to the inhalation can be recorded and the flow conditions can be adjusted. To measure the parameters, membrane / bending beam technology or piezoresistive elements are used in combination with a diaphragm or in combination with the Venturi measurement principle. To monitor the inhalation procedure, mechanically and / or electronically generated acoustic and / or optical signals can be emitted upon completion of a successful or unsuccessful inhalation.

[0009] The document US6182655 does not disclose in detail the structure of the reusable electronic module and how such a module monitors the inhalation procedure. Moreover, the sensor used is configured to sense the airflow and is not reliable and fault tolerant.

[0010] The document US Patent No. 5,505,195 discloses a dry powder inhaler device adapted to be attached to a conventional pharmaceutical dry powder dispenser having a mouthpiece built into one end of the dispenser. The device is designed to monitor the prescribed dosage of dry powder pharmaceutical that is received through the mouthpiece, lips, and into the mouth, throat, and respiratory system of the device user. The device includes an electronic housing attached to the dispenser to calculate and record on the electronic housing when the appropriate amount of dry powder is released inside the dispenser, when the appropriate amount of airflow is inhaled through the dispenser for mixing with the dry powder, and when each dispenser or dry powder container is removed and replaced.

[0011] The document US5505195 detects the delivery of the drug via a thermistor, a pressure device or an audio element device to detect the airflow of the user's inhalation. These sensors are not reliable and fault tolerant. Furthermore, the structure of the dry powder inhaler device of US5505195 does not prevent unintentional dosing like WO2004 / 01280.

[0012] Document WO 2015 / 133909 discloses a compliance monitoring device for monitoring patient use of a dry powder drug delivery device. The drug delivery device includes a drug reservoir housed in a body portion and a base portion rotatable relative to the body portion. The drug delivery device also includes drug supply means for supplying a dose of drug into an inhalation chamber, a mouthpiece through which the dose of drug may be inhaled by a user, and a replaceable cap. The compliance monitoring device includes a first portion for receiving and / or holding the base portion of the drug delivery device and a second portion for releasably securing the drug delivery device to the first portion. The compliance monitoring device may further include an electronics control module adapted to monitor and / or manipulate and / or store and / or transmit all collected compliance data related to patient use of the drug delivery device. An optical dose detector may be utilized to detect the rotation of the base portion relative to the body portion.

[0013] The structure of the dry powder inhaler device of WO 2015 / 133909 also does not prevent unintentional dosing like WO 2004 / 01280. Summary of the Invention

[0014] SUMMARY OF THE PRESENT EMBODIMENT It is an object of the present invention to overcome the above-mentioned drawbacks of previously known powder inhalers and to provide a powder inhaler with improved electronic detection of drug dosage.

[0015] In particular, it is an object of the present invention to provide a powder inhaler assembly provided with an electronic module capable of detecting movements of the mechanical parts of the powder inhaler and inferring drug dosing in a safe and reliable manner.

[0016] It is also an object of the present invention to provide an electronic module that is able to read the movements of such mechanical parts of a powder inhaler without imparting associated structural modifications to existing powder inhalers, such as, for example, those disclosed in the same applicant's WO 2004 / 012801 or WO 2016 / 000983.

[0017] At least one of the above objects is substantially achieved by an assembly, an electronic module, and a powder inhaler as described in one or more of the accompanying claims and / or according to one or more of the following aspects.

[0018] Aspects of the present invention are disclosed below.

[0019] According to a first independent aspect, a powder inhaler assembly comprises: 1. A powder inhaler comprising: a container for storing the powdered medicament; a mouthpiece and an inhalation channel connected to the mouthpiece; a metering device having a dosing recess, the metering device being movable relative to the container and the inhalation channel between an idle state in which the dosing recess is in communication with an opening of the container so as to be filled with a dose of powdered medicament, and a triggered state in which the dosing recess is in communication with the inhalation channel to enable inhalation through the mouthpiece of a dose of powdered medicament contained in the dosing recess; The present invention relates to a powder inhaler.

[0020] The powder inhaler assembly comprises: 1. An electronic module attached or attachable to a dry powder inhaler, comprising: a non-contact sensor, optionally an optical proximity sensor, arranged and configured to sense the position of at least a portion of the metering device to at least detect when the metering device is in a triggered state; The device further comprises an electronic module comprising:

[0021] In a second, separate aspect, the electronic module is attached or attachable to the powder inhaler.

[0022] Powder inhalers are a container for storing the powdered medicament; a mouthpiece and an inhalation channel connected to the mouthpiece; a metering device having a dosing recess, the metering device being movable relative to the container and the inhalation channel between an idle state in which the dosing recess is in communication with an opening of the container so as to be filled with a dose of powdered medicament, and a triggered state in which the dosing recess is in communication with the inhalation channel to enable inhalation through the mouthpiece of a dose of powdered medicament contained in the dosing recess; Equipped with.

[0023] The electronic module includes a non-contact sensor. The non-contact sensor is positioned and configured to sense a position of at least a portion of the metering device to at least detect when the metering device is in a triggered state, the non-contact sensor being an optical proximity sensor.

[0024] In a third independent aspect, a powder inhaler comprises: a container for storing the powdered medicament; a mouthpiece and an inhalation channel connected to the mouthpiece; a metering device having a dosing recess, the metering device being movable relative to the container and the inhalation channel between an idle state in which the dosing recess is in communication with an opening of the container so as to be filled with a dose of powdered medicament, and a triggered state in which the dosing recess is in communication with the inhalation channel to enable inhalation through the mouthpiece of a dose of powdered medicament contained in the dosing recess; - a casing with a corresponding window, in which the metering device and optionally the container and the intake channel are housed, the metering device being at least partially visible through the window; Equipped with the dry powder inhaler is configured to be attached to an electronics module that includes an optical proximity sensor; When the electronic module is attached to the powder inhaler, the window in the casing faces a window in the housing of the electronic module such that the optical proximity sensor faces at least a portion of the metering device to detect the position of said at least a portion of the metering device, at least to detect when the metering device is in a triggered state.

[0025] The applicant has determined that the present invention makes it possible to infer the delivery of a medicament dose in a safe and reliable manner by reading the configuration, position and actuation of the mechanical metering device of a powder inhaler via a non-contact sensor. The powder inhaler incorporates a breath-activated mechanism that is triggered when the inhalation flow exceeds a minimum level required to move a balancing part of the mechanism, which then releases a metered dose provided in the dosing recess. The actuation is achieved by releasing a spring part, a coupling member, which then moves a transparent plastic part called the dose protector forward, thus exposing the formulation to the inhalation channel in the mouthpiece. An attached electronic module is configured to detect at least a portion of this triggering of the mechanism and thus infer the release of the metered dose.

[0026] The Applicant has determined that the present invention makes it possible to carry out this detection without imparting any relevant structural modifications to existing powder inhalers, such as those disclosed in WO 2004 / 012801 or WO 2016 / 000983: in fact, there is no direct access to the internal volume of the powder inhaler.

[0027] In one aspect, the electronic module is removably attachable to the powder inhaler, optionally by a clip-on coupling. Coupling and uncoupling are easy and quick.

[0028] In one aspect, when the electronic module is removed from the dry powder inhaler, it is reusable with another dry powder inhaler, and when the medication in the old inhaler is exhausted, the same electronic module can be used with another new dry powder inhaler.

[0029] In one embodiment, the container is filled or configured to be filled with a quantity of powdered medicament corresponding to multiple doses, optionally 100-200 doses.

[0030] In one aspect, the non-contact sensor is a proximity sensor. A proximity sensor is a sensor that can detect the presence of a nearby object without any physical contact. Proximity sensors emit an electromagnetic field, or a beam of electromagnetic radiation, and look for a change in the field or return signal. Examples of proximity sensors are capacitive, inductive, optical, or photoelectric sensors.

[0031] In one aspect, the proximity sensor is an optical proximity sensor.

[0032] In one aspect, the optical proximity sensor operates in the near infrared spectrum.

[0033] In one aspect, the optical proximity sensor detects changes in reflected electromagnetic waves, optionally light, caused by movement of at least a portion of the metering device.

[0034] In one aspect, the powder inhaler comprises a casing, optionally a plastic casing, and the electronic module comprises a housing, optionally a plastic housing.

[0035] In one aspect, the housing is removably attachable to the casing, optionally by clipping the housing onto the casing or clipping the casing onto the housing.

[0036] In one aspect, the container, the intake channel, and the metering device are housed in a casing.

[0037] In one aspect, the casing has a corresponding window and the housing has a corresponding window.

[0038] In one aspect, when the electronic module is installed in the powder inhaler, the window in the casing faces the window in the housing such that the optical proximity sensor faces at least a portion of the metering device.

[0039] In one aspect, the optical proximity sensor is disposed within the housing.

[0040] In one aspect, the casing window and the housing window are optically transparent windows, said windows being transparent in the relevant electromagnetic spectrum for the optical proximity sensor.

[0041] There are no relevant modifications disclosed in existing inhalers, e.g. WO 2004 / 012801 or WO 2016 / 000983, other than a small optically transparent window forming part of the outer shell of the inhaler, which is located directly beneath the part of the mechanism that is triggered by the user's inhalation.

[0042] In one aspect, the optical proximity sensor comprises an emitter for emitting light, optionally in the near infrared spectrum, and an optical receiver having a light-sensitive portion, the output signal of the optical receiver being dependent on electromagnetic waves, optionally light, reflected by said at least part of the metering device.

[0043] In one embodiment, the emitter is a light emitting diode (LED) or a vertical-cavity, surface emitting laser (VCSEL).

[0044] In one aspect, the electronic module comprises an electronic control unit, optionally a microprocessor, operatively connected to the non-contact sensor.

[0045] In one aspect, the optical proximity sensor or the electronic control unit comprises a lock-in amplifier configured to reject optical noise, in particular to reject contributions from external light.

[0046] In one aspect, the shape and / or size of the casing window and / or the housing window are configured to modify the field of view (optical mask) of the optical proximity sensor to improve detection of the position of said at least a portion of the metering device.

[0047] In one aspect, a pinhole sensor cover is interposed between the optical proximity sensor and the at least a portion of the weighing device to modify the field of view (optical mask) of the optical proximity sensor to improve detection of the position of the at least a portion of the weighing device.

[0048] In one embodiment, at least one lens is interposed between the optical proximity sensor and said at least a portion of the metering device to better redirect and / or re-image the emitted and / or reflected light.

[0049] In one embodiment, the pinhole sensor cover and / or the at least one lens are part of the electronic module and / or the powder inhaler.

[0050] In one aspect, the electronic module comprises a printed circuit board (PCB).

[0051] In one aspect, the electronic module comprises a storage memory.

[0052] In one aspect, the electronic module comprises a communication interface, optionally a wireless communication interface, optionally a Bluetooth® communication interface.

[0053] In one aspect, the communication interface is configured to connect the electronic module to an external device, such as a computer, a smartphone, a tablet, etc. All operational parameters and data of the powder inhaler detected via the electronic module may be transferred to the external device.

[0054] In one aspect, the electronic module comprises at least a battery for powering the non-contact sensor, the electronic control unit, and the communication interface.

[0055] In one aspect, the non-contact sensor, electronic control unit, communication interface, storage memory, and battery are mounted on a printed circuit board.

[0056] In one aspect, the electronic control unit is disposed within the housing.

[0057] In one aspect, the electronic control unit comprises: - reading an output signal from the non-contact sensor at regular intervals; - optionally filtering and optionally normalizing the output; - comparing the output with a threshold value to identify whether the metering device is in a triggered state; The apparatus is configured to perform tasks including at least

[0058] In one embodiment, reading of the output signal from the non-contact sensor is performed at a rate greater than 10 Hz, optionally greater than 100 Hz, optionally 25 Hz (at regular intervals of less than 100 ms, optionally less than 10 ms, optionally 40 ms).

[0059] In one aspect, the optical components of the optical proximity sensor are active for only a fraction of a millisecond, optionally 125 μs, optionally in the range of 100-300 μs, and can be thought of as taking a "snapshot" of the current position of the metering device at regular intervals.

[0060] In one aspect, signal processing algorithms are implemented in the electronic control unit to filter the output.

[0061] In one aspect, the signal processing is performed at least in part by a non-contact sensor.

[0062] In one aspect, the step of filtering the output, optionally via a signal processing algorithm, comprises: - running a median filter on a number of samples, where the median filter output selects elements after sorting the samples in ascending order; - subtracting a previous median filter output from a current median filter output; Includes.

[0063] In one aspect, the metering device comprises a shuttle having a dosing recess, hi one aspect the shuttle is movable between a fill position corresponding to an idle state of the metering device, where the dosing recess is aligned with an opening of the container to be filled with a dose of powdered medicament, and an inhalation position corresponding at least to a triggered state of the metering device, where the dosing recess is aligned with the inhalation channel.

[0064] In one aspect, the shuttle is slidable between a fill position and an inlet position.

[0065] In one aspect, the metering device includes a protective member disposed between the shuttle and the intake channel.

[0066] In one aspect, the protective member is movable between a closed position, in which the protective member covers the dosing recess of the shuttle when the shuttle is in the inhalation position, thereby preventing powdered medicament contained in the dosing recess from entering the inhalation channel, and an open position, in which the protective member does not cover the dosing recess, thereby exposing the dosing recess to the inhalation channel to enable inhalation of a dose of powdered medicament contained in the dosing recess.

[0067] In one aspect, the protective member is disposed on a shuttle that is slidably movable between a closed position and an open position.

[0068] In one aspect, the non-contact sensor is positioned and configured to sense the position of at least the shuttle and / or the protective member.

[0069] In one aspect, in the triggered state, the shuttle is in the inhalation position and the guard is in the open position.

[0070] In one aspect, the metering device is movable relative to the container and the inlet channel to a ready state in which the shuttle is in the inlet position and the protective member is in the closed position.

[0071] In one aspect, the non-contact sensor is positioned and configured to detect a transition between the ready state and the triggered state.

[0072] In one aspect, the powder inhaler comprises an inhalation or breath-actuated mechanism coupled to the protective member such that when the protective member is in the closed position and inhalation suction force generated by the user exceeds a predetermined value, the inhalation actuated mechanism moves the protective member to the open position.

[0073] In one aspect, the inhalation actuated mechanism comprises an inhalation actuated member, optionally a flap, movable between a first position and a second position, the inhalation actuated member being coupled to the protective member such that when there is inhalation suction above a predetermined value, the inhalation actuated member is moved from the first position to the second position thereby moving the protective member from the closed position to the open position.

[0074] In one aspect, the non-contact sensor is positioned and configured to sense a position of at least a portion of the inhalation actuated mechanism.

[0075] In one aspect, the optical proximity sensor detects changes in reflected electromagnetic waves, optionally light, caused by movement of at least a portion of the inhalation actuated mechanism.

[0076] In one aspect, the inhalation actuated mechanism includes a coupling member coupling the inhalation actuated member to the protective member.

[0077] In one aspect, the suction actuated mechanism comprises at least a resilient element, optionally disposed on the coupling member.

[0078] In one aspect, the resilient element is positioned such that when the cover is closed and the shuttle is in the loading position, the resilient element holds the suction actuated member in its first position.

[0079] In one aspect, when the shuttle is pushed forward to the inhalation position by opening the cover, the resilient element releases the inhalation actuated member to allow the inhalation actuated member to be moved from its first position to its second position by inhalation suction forces exceeding a predetermined value.

[0080] In one aspect, the coupling member includes an extension that engages an opening formed in the protective member.

[0081] In one aspect, the coupling member extension is movably positioned within a longitudinal opening formed in the shuttle along its length such that the coupling member extension is freely movable within the longitudinal opening of the shuttle from its initial position to its end position, while movement of the shuttle from the suction position to the filling position moves the coupling member back to its initial position by abutting the coupling member extension against an edge of the longitudinal opening.

[0082] In one aspect, the non-contact sensor is positioned and configured to sense the position of at least a portion of the coupling member, optionally an extension of the coupling member.

[0083] In one aspect, the non-contact sensor is positioned and configured to sense a position of at least a portion of the metering device and / or at least a portion of the inhalation actuated mechanism.

[0084] In one embodiment, the optical proximity sensor detects changes in reflected electromagnetic waves, optionally light, due to movement of the shuttle and / or the protective member and / or the coupling member, optionally an extension of the coupling member.

[0085] In one aspect, the protective member has a specularly reflective surface and the shuttle has a diffusely reflective surface.

[0086] In one aspect, the coupling member has a surface that diffusely reflects light.

[0087] In one embodiment, the protective member has a smooth surface finish that reflects light like a mirror (specular reflection), while the other two components, the shuttle and the coupling member, reflect light more diffusely, also known as diffuse reflection.

[0088] In one embodiment the shuttle and / or the protective member and / or the coupling member have at least one marker detectable by an optical proximity sensor.

[0089] In one embodiment, the marker is part of the shuttle and / or protective member and / or coupling member or is an appendage coupled to said shuttle and / or protective member and / or coupling member.

[0090] In one aspect, the markers are diffusely reflective or specularly reflective markers.

[0091] In one aspect, the markers are diffusely reflective markers disposed on a specularly reflective surface, such as the surface of the protective member or of the shuttle.

[0092] In one aspect, the markers are specular reflective markers disposed on a diffusely reflective surface, such as the surface of the coupling member.

[0093] In one aspect, the non-contact sensor detects a transition to a triggered state when light is primarily reflected by the protective member.

[0094] In one aspect, the output signal of the optical receiver reaches a maximum when the light is primarily reflected by the protective member.

[0095] In one aspect, when the protective member is in the open position, the protective member faces the non-contact sensor.

[0096] In one aspect, the total light received by the optical proximity sensor is dominated by the combination of light reflected from all three portions (protector, coupling member and shuttle) and will be at its highest when the dominant reflection source is the dose protector. Due to the positioning of the optical proximity sensor, this occurs when the inhalation actuated mechanism of the dry powder inhaler is triggered.

[0097] In one aspect, a powder inhaler includes a casing and a cover rotatably coupled to the casing.

[0098] In one aspect, the electronics module is attached or attachable to a portion of the powder inhaler opposite the cover.

[0099] In one aspect, the cover is movable between a closed position in which the cover covers the mouthpiece and an open position in which the cover exposes the mouthpiece.

[0100] In one aspect, the electronic module includes a cover opening switch.

[0101] In one aspect, the cover opening switch is operatively connected to the electronic control unit.

[0102] In one aspect, the shuttle is moved from the fill position to the inlet position by overcoming the range of rotational movement of the cover and releasing the cover from its closed position.

[0103] In one aspect, releasing the cover from its closed position beyond the range of rotational travel of the cover triggers a cover open switch, which causes activation of a non-contact sensor.

[0104] In one embodiment, the range of rotational movement is about 80 degrees.

[0105] In one aspect, closing the cover causes the shuttle to move from the intake position to the fill position.

[0106] In one aspect, closing the cover releases a cover open switch, which causes the non-contact sensor to deactivate.

[0107] In one aspect, the non-contact sensor (and detection of the state of the metering device) is only active when the cover is opened beyond said range of rotational travel.

[0108] In one aspect, the cover opening switch comprises a mechanical detector switch and a spring loaded mechanical part, optionally shaped like an arm.

[0109] In one aspect, the spring-loaded mechanical part is movable between a rest position in which the spring-loaded mechanical part does not activate the mechanical detector switch when the cover is in the closed position, and an operating position in which the spring-loaded mechanical part presses the mechanical detector switch when the cover is in the open position.

[0110] In one aspect, the spring is configured to move the spring-loaded mechanical part toward a rest position when the cover is in the closed position.

[0111] In one aspect, the electronics module includes an attachment detection switch that interacts with the powder inhaler when the electronics module is attached to the powder inhaler.

[0112] In one aspect, the attachment detection switch is a mechanical detector switch.

[0113] In one aspect, the attachment detection switch is operatively connected to the electronic control unit.

[0114] In one aspect, attachment of the electronic module to the dry powder inhaler triggers an attachment detection switch, which causes activation of a cover open switch.

[0115] In one aspect, removal of the electronic module from the dry powder inhaler releases the attachment detection switch, which causes the cover opening switch to be deactivated.

[0116] In one aspect, the closed or open state of the cover is monitored only when the electronic module is installed.

[0117] In one embodiment, the electronic module uses two mechanical switches to determine a) when it is attached to the inhaler and b) when the cover of the inhaler is open and therefore actuation of the internal mechanism can occur.

[0118] In one aspect, the electronic module comprises: an idle state, in which the electronic module is attached to the dry powder inhaler, the attachment detection switch is triggered, the cover is closed, the cover opening switch is released, and inhalation cannot occur; a ready state, in which the cover is open, the cover opening switch is triggered and the metering device can be triggered; - a triggered state in which the inhalation flow released the protective element and a metered dose could be delivered; The system is structured to distinguish between three states:

[0119] In one embodiment, the electronic control unit is configured to store data regarding events of the powder inhaler, such as triggering of the metering device, and / or attachment / detachment of the electronic module to / from the powder inhaler, and / or opening / closing of a cover, in a storage memory and / or to transmit to an external device via a communication interface.

[0120] In one aspect, the electronic control unit is configured to first store the data in a storage memory and then, after a time delay, transmit the data to an external device.

[0121] In one aspect, the electronic control unit is configured to send said data to an external device upon request. While a connection to an external device is not available, the data can be stored only in the electronic control unit. Thus, the electronic control unit does not require an external device to operate properly and save data. [Brief description of the drawings]

[0122] [Figure 1] FIG. 1 is an isometric view of a powder inhaler assembly according to the present invention in a closed configuration. [Diagram 2] FIG. 1 is an isometric view of a powder inhaler assembly according to the present invention in an open configuration. [Diagram 3] FIG. 3 is an isometric view of the electronics module of the powder inhaler assembly of FIGS. 1 and 2. [Figure 4] FIG. 4 is another isometric view of the electronic module of FIG. 3. [Diagram 5] FIG. 5 is a cross-sectional view of the powder inhaler assembly of FIGS. 1 to 4 in a first state. [Figure 6] FIG. 6 is an enlarged portion of FIG. 5. [Figure 7] FIG. 7 is a cross-sectional view of the powder inhaler assembly of FIGS. 1 to 6 in a second state. [Figure 8] FIG. 8 is an enlarged portion of FIG. [Figure 9] FIG. 9 is a cross-sectional view of the powder inhaler assembly of FIGS. 1 to 8 in a third state. [Figure 10] FIG. 10 is an enlarged portion of FIG. [Figure 11] FIG. 1 is an isometric view of some internal elements of a powder inhaler. [Figure 12] FIG. 12 is another isometric view of the internal elements of FIG. 11. [Figure 13] FIG. 12 is a further isometric view of the internal elements of FIG. 11. [Figure 14]1A-1D are diagrams of a portion of the electronic module in each configuration. [Figure 15] FIG. 15 shows the portion of FIG. 14 in another configuration. [Figure 16] FIG. 16 is a diagram of signals associated with the powder inhaler assembly of FIGS. 1 to 15. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0123] With reference to the accompanying drawings, Figures 1 and 2 show a powder inhaler assembly 1 according to the invention. The powder inhaler assembly 1 comprises a powder inhaler 2 and an electronic module 3. The powder inhaler 2 may be substantially the same as that disclosed in the document WO 2004 / 012801 or in the document WO 2016 / 000983 of the same applicant. Therefore, the following description details only the main parts and the differences with respect to WO 2004 / 012801 or WO 2016 / 000983.

[0124] powder inhaler The powder inhaler 2 shown in Figure 1 comprises a casing 4 and a cover 5 pivotally or rotatably connected to the casing 4. As can be seen from Figure 2, the cover 5 can be opened to expose a mouthpiece 6 through which a user can inhale powdered medicament. At the top front side of the mouthpiece 6, a slot 7 is formed in the casing 4 to allow an air inlet.

[0125] The powder inhaler 2 comprises a container 8 for storing the powdered medicament, an inhalation channel 9 connected to the mouthpiece 6, and a metering device 10. The inhalation channel 9 has a first opening connected to the mouthpiece and a second opening opposite to the first opening. All these elements are housed inside a casing 4, as shown in Figures 5, 7 and 9.

[0126] The container 8 is filled or adapted to be filled with a quantity of powdered medicament corresponding to multiple doses, for example up to 100-200 doses.

[0127] The metering device 10 is movable relative to the container 8 and relative to the inhalation channel 9 between an idle state in which the dosing recess 11 is in communication with an opening 12 of the container 8 so as to be filled with a dose of powdered medicament, and a triggered state in which the dosing recess 11 is in communication with the inhalation channel 9 to enable inhalation of a dose of powdered medicament contained in the dosing recess 11 through the mouthpiece 6.

[0128] The metering device 10 comprises a shuttle 13 having a dosing recess 11 made in its upper surface like a cup-shaped recess. The shuttle 13 is slidably movable between a filling position (FIG. 5) and an inhalation position (FIGS. 7 and 9). The filling position corresponds to the idle state (FIG. 5) of the metering device 10, in which the dosing recess is aligned with the opening 12 of the container 8 so as to be filled with a dose of powdered medicament. The inhalation position corresponds to the ready state (FIG. 7) and to the triggered state (FIG. 9) of the metering device 10, which will be described in more detail later, in which the dosing recess 11 is aligned with the inhalation channel 9.

[0129] The shuttle 13 is mechanically coupled to the cover 5 such that opening the cover 5 beyond a range of rotational movement from the closed position causes the shuttle 13 to move from the fill position to the suction position. Closing the cover 5 causes the shuttle 13 to move from the suction position back to the fill position. Figure 5 shows the cover 5 in the closed position and the shuttle 13 in the fill position. Figures 7 and 9 show the cover 5 in the open position and the shuttle 13 in the suction position. For example, the range of rotational movement that causes the shuttle to slide from the fill position to the suction position is 80 degrees.

[0130] The metering device 10 further comprises a protective member 14 provided between the shuttle 13 and the suction channel 9. The protective member 14 is a transparent or translucent plate arranged between the second opening of the suction channel 9 and the shuttle 13. The protective member 14 has a smooth surface finish that reflects light in a mirror-like manner (specular reflection).

[0131] The protective member 14 is parallel to the shuttle 13 and is slidable on the shuttle 13 between a closed position and an open position. In the closed position, the protective member 14 is shifted rearward, towards the second opening of the suction channel 9 and towards the container 8. In the closed position, the rear part of the protective member 14 may at least partially close the second opening of the suction channel 9. In the open position, the protective member 14 is shifted forward, towards the wall of the casing 4. In the open position, the rear part of the protective member 14 leaves the second opening of the suction channel 9 open.

[0132] When the shuttle 13 is in the filling position, the protective member 14 is in the closed position. When the shuttle 13 is in the intake position, the protective member 14 may be moved between the closed and open positions. The metering device 10 is therefore configured to assume the three different states described above (idle, ready, triggered), which are determined by the positions of the shuttle 13 and the protective member 14, as disclosed in Table 1 below. [Table 1] In the idle state of Figures 5 and 6, the shuttle 13 is in the loading position and the protective member 14 is in the closed position. The protective member 14 does not cover the dosing recess 11. The dosing recess 11 is in communication with the opening 12 of the container 8 for receiving a drug dose.

[0133] 7 and 8, the shuttle 13 is in the inhalation position and the protective member 14 is in the closed position. The protective member 14 covers the dosing recess 11. The protective member 14 prevents the powdered medicament contained in the dosing recess 11 from entering the inhalation channel 9 and being lost when the inhaler is rotated or moved at an angle before an inhalation maneuver or when the user blows into the mouthpiece.

[0134] 9 and 10, the shuttle 13 is in the inhalation position and the protective member 14 is in the open position. The protective member 14 does not cover the dosing recess 11, thereby exposing it to the inhalation channel 9 to enable the user to inhale a dose of powdered medicament contained therein.

[0135] The powder inhaler 2 comprises a breath or inhalation actuated mechanism 15 coupled to a protective member 14. The inhalation actuated mechanism 15 comprises an inhalation actuated member 16 shaped like a flap, a coupling member 17 and an elastic element 18 arranged on the coupling member 17 (see Figs. 11, 12 and 13). A further elastic element, not shown in the attached drawings, may be attached to the coupling member 17 on the opposite side to the elastic element 18 (as in WO 2016 / 000983). The flap 16 is coupled to the protective member 14 via the coupling member 17 such that in the presence of an inhalation suction force exceeding a predetermined value, the flap 16 is moved from a first position to a second position, thereby moving the protective member 14 from a closed position to an open position. The flap 16 is arranged inside the casing 4 and close to the slot 7. In the first position (Fig. 5), the flap 16 separates the slot 7 from the inhalation channel 9 and is located in the main air flow path. The flap 16 provides resistance and positive feedback when a user breathes into the device. In the second position (FIG. 9), the flap 16 is rotated relative to the first position to open the slot 7 and allow air to flow through the slot 7 into the inhalation channel 9 and out of the mouthpiece 6.

[0136] The elastic element 18 is arranged such that said elastic element 18 holds the flap 16 in its first position. When the shuttle 13 is pushed forward by opening the cover 5, the elastic element 18 is compressed and loaded, and the restoring force exerted on the flap 16 is released, so that the flap 16 can pivot or rotate from the first position to a second position, pivoted downwards relative to the first position, if there is a sufficiently high inhalation suction force in the inhalation channel 9. The further elastic element provides the coupling member 17 with a suitable force that is released during inhalation. The downward movement of the flap 16 during inhalation releases part of the force exerted by the further elastic element on the coupling member 17, while closing the cover 5 tensions the further elastic element.

[0137] 11-13, the flaps 16 are hinged to the casing 4 for rotation between first and second positions about respective axes of rotation XX substantially perpendicular to the main axis ZZ of the suction channel 9 (FIGS. 5, 7 and 9). The coupling members 17 are also hinged to the casing 4 for rotation between respective first and second positions about respective axes of rotation YY substantially perpendicular to the main axis ZZ of the suction channel 9 and parallel to the axis of rotation XX.

[0138] The coupling member 17 includes an arm 19 that projects toward and engages with the flap 16 such that counterclockwise rotation of the flap 16 from a first position to a second position (with reference to Figures 5, 7, 9, 11, 12 and 13) causes clockwise rotation of the coupling member 17 from its respective first position toward its respective second position.

[0139] In order to move the protective member 14 from a closed position to an open position when the coupling members 17 move from their respective first positions to their respective second positions and vice versa, the coupling members 17 are provided with extensions 20 which engage with openings 21 formed in the protective member 14.

[0140] The extension 20 of the coupling member 17 is also movably positioned within a longitudinal opening 22 formed in the shuttle 13 along its length such that while the extension 20 is free to move within the longitudinal opening 22, movement of the shuttle 13 from the suction position to the filling position causes the extension 20 of the coupling member 17 to abut against the edge of the longitudinal opening 22, thereby moving the coupling member 20 back to its initial first position.

[0141] The casing 4 has an optically transparent window 23 located adjacent to the metering device 10 such that the metering device 10 is at least partially visible through the window 23 from outside the casing 4. In particular, the shuttle 13, the protective member 14 and the end of the extension 20 are visible through the window 23. The protective member 14 has a smooth surface finish that reflects light like a mirror (specular reflection), whereas the shuttle 13 and the extension 20 reflect light more diffusely (scattered reflection). All elements of the powder inhaler 2 may be made of a plastic material.

[0142] Electronic Module The electronic module 3 is configured to be removably attached to the powder inhaler 2 so that the same electronic module 3 can be used with another new powder inhaler 2 once the medicament in the old inhaler has been exhausted. In the embodiment shown in the accompanying figures, the electronic module 3 is attached or attachable to a part of the powder inhaler 2 opposite to the cover 5.

[0143] The electronic module 3 comprises a plastic housing 24 which is removably attachable to the casing 4 of the powder inhaler by a clip-on connection. A non-limiting embodiment of the housing 24 of the electronic module 3 shown in the accompanying figures comprises a rigid clip 25 and a flexible clip 26 shaped to mate with respective recesses in the casing 4 of the powder inhaler 2.

[0144] The housing 24 has an upper surface that is configured to face the lower surface of the powder inhaler 2, which has an optically transparent window 23, when the electronic module 3 is attached to the powder inhaler 2. The upper surface of the electronic module 3 is also provided with a corresponding optically transparent window 27, such that the window 23 of the casing 4 faces the window 27 of the housing 24 when the electronic module 3 is attached to the powder inhaler 2.

[0145] Inside the housing 24, a printed circuit board (PCB) 28 is housed. The printed circuit board (PCB) 28 supports a microprocessor, a wireless communication interface (e.g. Bluetooth®) and a storage memory, electronically connected from one to the other. The communication interface is configured to connect the electronic module to an external device, such as a computer, a smartphone, a tablet, etc. All operating parameters and data of the dry powder inhaler 2 detected via the electronic module 3 may be stored in the storage memory and / or transferred to the external device.

[0146] A non-contact sensor 29 is mounted on the printed circuit board (PCB) 28 and is operatively connected to the microprocessor. The non-contact sensor 29 shown in the attached figures is an optical proximity sensor and comprises an emitter and a receiver arranged side by side. The emitter emits light, for example in the near infrared spectrum, and the receiver is an optical receiver having a light sensitive portion. The emitter may be an LED (light emitting diode) or a VCSEL (vertical cavity surface emitting laser). The position of the optical proximity sensor 29 on the printed circuit board (PCB) 28 and the position of the printed circuit board (PCB) 28 in the housing 24 are such that the optical proximity sensor 29 is disposed in the housing 24 and faces the optically transparent window 27 of said housing 24.

[0147] The emitted and reflected light of the optical proximity sensor 29 passes through an optically transparent window 27 of the housing 24. When the electronic module 3 is mounted in the powder inhaler 2, the optical proximity sensor 29 faces the shuttle 13, the protective member 14 and the end of the extension 20. The output signal of the optical receiver depends on the amount of light reflected by said parts. The optical proximity sensor 29 is arranged and configured to sense the position of at least a part of the metering device 10 to at least detect when the metering device 10 is in a triggered state. In particular, the optical proximity sensor 29 is arranged and configured to sense the position of the shuttle 13, the protective member 14 and the extension 20 of the coupling member 17.

[0148] In order to ensure proper optical detection of the metering device (to better detect signal changes due to movement of the metering device 10), the shape and / or size of the window 23 in the casing 4 of the powder inhaler 2 and / or the window 27 in the plastic housing 24 of the electronic module 3 may be configured to change the specific field of view (optical mask) of the optical proximity sensor 29.

[0149] The electronic module 3 further comprises an attachment detection switch 30 that interacts with the powder inhaler 2 when the electronic module 3 is attached to the powder inhaler 2. The attachment detection switch 30 is a mechanical detector switch mounted on the printed circuit board (PCB) 28, operatively connected to the microprocessor, and comprises a pin 31 (FIGS. 3, 4, 14 and 15) protruding from the top surface of the housing 24 through a corresponding aperture so as to mechanically interact with the powder inhaler 2 when the electronic module 3 is attached to the powder inhaler 2.

[0150] The electronic module 3 further comprises a cover opening switch 32 operatively connected to the microprocessor. The cover opening switch 32 comprises a mechanical detector switch 33 mounted on the printed circuit board (PCB) 28 and operatively connected to the microprocessor, and a spring-loaded mechanical part 34 shaped like an arm (FIGS. 4, 14 and 15). A part of said arm 34 is arranged outside the housing 24 of the electronic module 3 so as to mechanically interact with the cover 5 of the powder inhaler 2 when the cover 5 is opened beyond the range of rotational movement of said cover 5 from the closed position. When the cover 5 is closed, the arm 34 is in a rest position in which it does not activate the mechanical detector switch 33. When the cover 5 is opened beyond said range of rotational movement, the arm 34 is in an operating position in which it presses the mechanical detector switch 33. A spring is configured to move the spring-loaded arm 34 towards the rest position when the cover 5 returns to the closed position.

[0151] Attaching the electronic module 3 to the dry powder inhaler 2 triggers the attachment detection switch 30, which causes the activation of the cover open switch 32. The closed or open state of the cover 5 is monitored only when the electronic module 3 is attached. Opening the cover 5 beyond the range of rotational movement of the cover, e.g. 80 degrees, triggers the cover open switch 32, which causes the activation of the optical proximity sensor 29. Closing the cover 5 releases the cover open switch 32, which causes the deactivation of the optical proximity sensor 29. Removing the electronic module 3 from the dry powder inhaler 2 releases the attachment detection switch 30, which causes the deactivation of the cover open switch 32.

[0152] The electronic module 3 uses an attachment detection switch 30 and a cover open switch 32 to determine a) when the electronic module 3 is attached to the powder inhaler 2 and b) when the cover 5 of the powder inhaler is open and therefore operation of the internal mechanism can occur.

[0153] The electronic module 3 further comprises a battery 35 mounted on the printed circuit board (PCB) 28 and configured to power electronic elements such as the optical proximity sensor 29, the microprocessor, the communication interface, the storage memory, the installation detection switch 30 and the cover opening switch 32.

[0154] Figures 5 and 6 show an electronic module 3 attached to a powder inhaler 2 to form a powder inhaler assembly 1 with a metering device 10 in an idle state, with the cover 5 closed. In the idle state, the attachment detection switch 30 is triggered, the cover opening switch 32 is active and the optical proximity sensor 29 is inactive. No light is emitted by the emitter of the optical proximity sensor 29.

[0155] 7 and 8 show a powder inhaler assembly with a metering device 10 in a ready state, with the cover 5 open. In the ready state, the cover open switch 32 is triggered and the optical proximity sensor 29 is active. The emitter emits light towards the shuttle 13, the protective member 14 and the end of the extension 20. The light is reflected by the shuttle 13, the protective member 14 and the end of the extension 20 (reflecting the light so that it is scattered) and is captured by the optical receiver. The microprocessor reads the output signal from the optical receiver at regular intervals, for example at a rate of 25 Hz (every 40 ms). The optical receiver is only active for a fraction of a millisecond, for example 125 μs, and can be thought of as taking a "snapshot" of the current position of the metering device at regular intervals.

[0156] Inhalation by the user moves the metering device 10 to the triggered state of Figures 9 and 10, where the emitted light is primarily reflected off the guard member 14 (which reflects light specularly) and then captured by the optical receiver. When the inhalation actuated mechanism 15 is triggered, it takes approximately 4ms for the metering device 10 to move from its ready state to its triggered state. This transition is detected by the optical proximity sensor 29, which infers the triggering of the inhalation actuated mechanism 15 when the light is primarily reflected off the guard member 14.

[0157] An exemplary time series output from the optical proximity sensor 29 during triggering of the inhaler's internal mechanisms is shown in the top graph of Figure 16. The optical proximity sensor 29 is counting starting around 1140 (baseline reading) and suddenly rising around 2.5s to reach over 1160, resulting in a signal level difference (contrast) of over 20. Fluctuations in the sensor's output can also be observed at 1.2s and 3.8s in the plot due to mechanical forces resulting from manual manipulation of the powder inhaler assembly and also from moving the mouthpiece cover 5 which is directly connected to the position of the shuttle 13.

[0158] A signal processing algorithm is implemented in the microprocessor to distinguish between these and signals caused by state transitions of the metering device 10 and the inhalation actuated mechanism 15. This algorithm can be thought of as a kind of "edge detector" since it is tuned to respond to fast positive signal increases caused by the transient movement of the extension 20 of the coupling member 17 and the guard member 14 when the powder inhaler 2 is triggered to release a metered dose.

[0159] The algorithm performs the following tasks: -Perform a median filter on the last 7 samples, where the median filter output selects the 4th element after sorting the samples in ascending order. -Subtract the previous median filter output from the current median filter output. This requires a previous valid median filter output to produce a value. -Compare the value obtained above with a threshold, and if the value is greater than the threshold, it is determined to be "triggered", otherwise it is determined to be "not triggered".

[0160] Figure 16 shows the filtered signal (middle graph) as well as the output signal of the algorithm over time (bottom graph) as a function of the received reflected light. As shown in the bottom graph of Figure 16, the triggering of the inhalation actuated mechanism 15 and the triggering of the metering device 10 at approximately 2.5s on the graph results in a sharp peak of over 20 counts in the output of the algorithm, which is detected as a successful actuation.

[0161] The above behavior means that when the electronic module 3 is correctly installed in the powder inhaler 2 and actively monitors the position of the internal mechanisms, mainly the shuttle 13, the extension 20 and the protective member 14, the electronic module 3 is able to infer the successful release of a metered dose of drug formulation, so that it can capture the fast transitions that occur when the inspiratory flow triggers the release of drug.

[0162] The electronic module 3 may be provided with indicators 36, such as LED indicators, operatively connected to the printed circuit board (PCB) 28 and positioned on the housing 24 for visibility to a user. These indicators may provide information regarding the status of the powder inhaler 2. For example, the indicators may signal when the electronic module 3 is properly attached to the powder inhaler 2, and / or upon successful emission of a metered dose of drug, and / or when the electronic module 3 is wirelessly connected to an external device, and / or when the cover 5 is opened or closed.

[0163] In some embodiments not shown, to improve the configuration of the moving part optical detection and metering device 10, the shuttle 13, and / or the protective member 14, and / or the coupling member 17 have at least one diffuse or specular reflective marker that is easily detectable by the optical proximity sensor 29. For example, a diffuse reflective marker may be attached to the specular reflective surface of the protective member 14, facing the optical proximity sensor 29.

[0164] In some other embodiments not shown, the position of the optical proximity sensor 29 relative to the metering device 10 may be other than that shown in Figs. 5-10, so that the part or parts of the metering device 10 that are detected may also be different. With reference to Figs. 6, 8 or 10, the optical proximity sensor 29 may be located a little further to the left on the printed circuit board (PCB) 28. In one embodiment, when the metering device 10 is in the ready state, the emitted light is mainly reflected off the clear protective member 14 (which reflects light in a specular manner), and when the metering device 10 is in the triggered state, the emitted light is mainly reflected off the diffuse reflecting markers of the protective member 14. In one embodiment, when the metering device 10 is in the ready state, the emitted light is mainly reflected off the clear protective member 14 (which reflects light in a specular manner), and when the metering device 10 is in the triggered state, the emitted light is mainly reflected off the coupling member 17 (which reflects light in a scattered manner). In one embodiment, when the metering device 10 is in the ready state, the emitted light hits nothing, and when the metering device 10 is in the triggered state, the emitted light hits and is primarily reflected off of the diffuse reflective markers of the protective member 14 .

[0165] In some other embodiments not shown, a pinhole sensor cover (a cover provided with a small aperture) and / or at least one lens, not shown, may be interposed between the optical proximity sensor 29 and said at least part of the metering device 10. The pinhole sensor cover and / or the lens may be located in the plastic housing 24 of the electronic module 3 or in the casing 4 of the powder inhaler 2. These elements may be useful to better detect signal changes due to movements of the metering device 10.

[0166] The pinhole sensor cover is employed to change the inherent field of view (optical mask) of the optical proximity sensor 29 (in addition to, or instead of, the shape and / or size of the window 23 in the casing 4 and / or the window 27 in the plastic housing 24).

[0167] Lenses are used to redirect and / or re-image the emitted and / or reflected light. The emitted light can be better focused onto the target portion of the metering device 10. The reflected light can be better re-imaged onto the optical receiver.

[0168] In other embodiments the optical proximity sensor 29 or the electronic control unit may comprise a lock-in amplifier configured to eliminate noise, in particular noise due to contributions from optical signals outside the casing (e.g. ambient light). A lock-in amplifier is a type of amplifier that is known per se and is able to extract a signal with a known carrier from a noisy environment.

Claims

1. A powder inhaler assembly comprising a powder inhaler (2) and an electronic module (3) attached or attachable to said powder inhaler (2), The powder inhaler (2), A container (8) for storing a powdered medicament; a mouthpiece (6) and an inhalation channel (9) connected to said mouthpiece (6); a metering device (10) having a dosing recess (11), said metering device (10) being movable relative to said container (8) and said inhalation channel (9) between an idle state, in which said dosing recess (11) is in communication with an opening (12) of said container (8) so as to be filled with a dose of said powdered medicament, and a triggered state, in which said dosing recess (11) is in communication with said inhalation channel (9) to enable inhalation of said dose of said powdered medicament contained in said dosing recess (11) through said mouthpiece (6); Equipped with The metering device (10) a shuttle (13) having the dosing recess (11), the shuttle (13) being movable between a filling position corresponding to the idle state of the metering device (10), the dosing recess (11) being aligned with the opening (12) of the container (8) so that the dose of the powdered medicament is filled, and an inhalation position corresponding at least to the trigger state of the metering device (10), the dosing recess (11) being aligned with the inhalation channel (9); a protective member (14) provided between the shuttle (13) and the inhalation channel (9), the protective member (14) being movable between a closed position, in which the protective member (14) covers the dosing recess (11) of the shuttle (13) when the shuttle (13) is in the inhalation position, thereby preventing the powdered medicament contained in the dosing recess (11) from entering the inhalation channel (9), and an open position, in which the protective member (14) does not cover the dosing recess (11), thereby exposing the dosing recess (11) to the inhalation channel (9) to allow inhalation of the dose of the powdered medicament contained in the dosing recess (11); Further equipped with The electronic module (3) a non-contact sensor (29) positioned and configured to sense a position of at least a portion of said weighing device (10) to at least detect when said weighing device (10) is in said triggered state; Equipped with A powder inhaler assembly, wherein the non-contact sensor (29) is positioned and configured to detect the position of the shuttle (13) and the position of the protective member (14).

2. 2. The powder inhaler assembly of claim 1, wherein the powder inhaler (2) comprises a casing (4), the electronic module (3) comprises a housing (24), the metering device (10) as well as the container (8) and the inhalation channel (9) are housed in the casing (4), the casing (4) has a corresponding window (23), and the housing (24) has a corresponding window (27), and when the electronic module (3) is attached to the powder inhaler (2), the window (23) of the casing (4) faces the window (27) of the housing (24) such that the non-contact sensor (29) faces at least a part of the metering device (10).

3. 3. The powder inhaler assembly of claim 2, wherein the non-contact sensor (29) is an optical proximity sensor and the window (23) in the casing (4) and the window (27) in the housing (24) are optically transparent windows.

4. 4. A powder inhaler assembly according to claim 1, wherein the metering device (10) is movable relative to the container (8) and the inhalation channel (9) to a ready state in which the shuttle (13) is in the inhalation position and the protective member (14) is in the closed position, and the non-contact sensor (29) is arranged and configured to detect a transition between the ready state and the trigger state.

5. 5. The powder inhaler assembly of claim 1, wherein the powder inhaler (2) comprises an inhalation actuated mechanism (15) coupled to the protective member (14) such that the inhalation actuated mechanism (15) moves the protective member (14) to the open position when an inhalation suction force generated by a user when the protective member (14) is in the closed position exceeds a predetermined value, and the non-contact sensor (29) is positioned and configured to detect the position of at least a part of the inhalation actuated mechanism (15).

6. 6. The powder inhaler assembly of claim 5, wherein the inhalation actuated mechanism (15) comprises an inhalation actuated member (15) and a coupling member (17) coupling the inhalation actuated member (15) to the protective member (14), and the non-contact sensor (29) is positioned and configured to detect the position of at least a portion of the coupling member (17).

7. A powder inhaler assembly as described in claim 6 when claim 5 is dependent on claim 3, wherein the optical proximity sensor (29) is configured to detect a change in reflected electromagnetic waves due to movement of the shuttle (13) and / or the protective member (14) and / or the connecting member (17).

8. Powder inhaler assembly according to any one of the preceding claims, wherein the protective member (14) faces the non-contact sensor (29) when the protective member (14) is in the open position.

9. The electronic module (3) comprises an electronic control unit operatively connected to the non-contact sensor (29), the electronic control unit comprising: reading an output signal from the non-contact sensor (29); filtering the output; comparing said output with a threshold value to identify whether said metering device (10) is in said triggered state; A powder inhaler assembly according to any one of claims 1 to 8, configured to perform tasks including at least:

10. The powder inhaler (2) comprises a casing (4) and a cover (5) rotatably coupled to the casing (4) such that the cover (5) is movable between a closed position in which the cover (5) covers the mouthpiece (6) and an open position in which the cover (5) exposes the mouthpiece (6), and the electronic module (3) comprises a cover opening switch (32) and is adapted to open the cover (5) when the cover (5) is moved from the closed position to a position beyond the range of rotational movement of the cover (5).

10. The powder inhaler assembly according to claim 1, wherein opening the cover (5) moves the shuttle (13) from the charging position to the inhalation position and triggers the cover opening switch (32) thereby activating the non-contact sensor (29), and closing the cover (5) moves the shuttle (13) from the inhalation position to the charging position and releases the cover opening switch (32) thereby deactivating the non-contact sensor (29).

11. The powder inhaler assembly of claim 10, wherein the electronic module (3) comprises an attachment detection switch (30) that interacts with the powder inhaler (2) when the electronic module (3) is attached to the powder inhaler (2), and wherein attaching the electronic module (3) to the powder inhaler (2) triggers the attachment detection switch (30), thereby activating the cover opening switch (32), and removing the electronic module (3) from the powder inhaler (2) releases the attachment detection switch (30), thereby causing deactivation of the cover opening switch (32).

12. Powder inhaler assembly according to any one of the preceding claims, wherein the electronic module (3) is removably attachable to the powder inhaler (2) by a clip-on connection.

13. A powder inhaler assembly according to any one of claims 1 to 12, wherein the electronic module (3) comprises an electronic control unit and a storage memory, the electronic control unit being configured to first store data in the storage memory and then, after a time delay, send the data to an external device.

14. An electronic module attached or attachable to a powder inhaler, said powder inhaler (2) comprising: A container (8) for storing a powdered medicament; a mouthpiece (6) and an inhalation channel (9) connected to said mouthpiece (6); a metering device (10) having a dosing recess (11), said metering device (10) being movable relative to said container (8) and said inhalation channel (9) between an idle state, in which said dosing recess (11) is in communication with an opening of said container (8) so as to be filled with a dose of said powdered medicament, and a triggered state, in which said dosing recess (11) is in communication with said inhalation channel (9) to enable inhalation of said dose of said powdered medicament contained in said dosing recess (11) through said mouthpiece (6); Equipped with The metering device (10) a shuttle (13) having the dosing recess (11), the shuttle (13) being movable between a filling position corresponding to the idle state of the metering device (10), the dosing recess (11) being aligned with the opening (12) of the container (8) so that the dose of the powdered medicament is filled, and an inhalation position corresponding at least to the trigger state of the metering device (10), the dosing recess (11) being aligned with the inhalation channel (9); a protective member (14) provided between the shuttle (13) and the inhalation channel (9), the protective member (14) being movable between a closed position, in which the protective member (14) covers the dosing recess (11) of the shuttle (13) when the shuttle (13) is in the inhalation position, thereby preventing the powdered medicament contained in the dosing recess (11) from entering the inhalation channel (9), and an open position, in which the protective member (14) does not cover the dosing recess (11), thereby exposing the dosing recess (11) to the inhalation channel (9) to allow inhalation of the dose of the powdered medicament contained in the dosing recess (11); Further equipped with The electronic module (3) a non-contact sensor (29) arranged and configured to sense a position of at least a portion of the weighing device (10) to at least detect when the weighing device (10) is in the triggered state, the non-contact sensor (29) being an optical proximity sensor; The non-contact sensor (29) is positioned and configured to sense the position of the shuttle (13) and the position of the protective member (14), an electronic module.

15. An electronic module as described in claim 14, comprising an electronic control unit and a storage memory, the electronic control unit configured to first store data in the storage memory and then send the data to an external device after a time delay.

16. 1. A powder inhaler comprising: A container (8) for storing a powdered medicament; a mouthpiece (6) and an inhalation channel (9) connected to said mouthpiece (6); A metering device (10) having a dosing recess (11), said metering device (10) being movable relative to said container (8) and said inhalation channel (9) between an idle state, in which said dosing recess (11) is in communication with an opening (12) of said container (8) so as to be filled with a dose of said powdered medicament, and a trigger state, in which said dosing recess (11) is in communication with said inhalation channel (9) to enable inhalation of said dose of said powdered medicament contained in said dosing recess (11) through said mouthpiece (6), said metering device (10) comprising a shuttle (13) having said dosing recess (11), said shuttle (13) having a filling position corresponding to said idle state of said metering device (10), in which said dosing recess (11) is aligned with said opening (12) of said container (8) so as to be filled with said dose of said powdered medicament, and a filling position corresponding to at least said trigger state of said metering device (10). a shuttle (13) movable between an inhalation position, in which the dosing recess (11) is aligned with the inhalation channel (9), and a protective member (14) provided between the shuttle (13) and the inhalation channel (9), the protective member (14) movable between a closed position, in which the protective member (14) covers the dosing recess (11) of the shuttle (13) when the shuttle (13) is in the inhalation position, thereby preventing the powdered medicament contained in the dosing recess (11) from entering the inhalation channel (9), and an open position, in which the protective member (14) does not cover the dosing recess (11), thereby exposing the dosing recess (11) to the inhalation channel (9) to allow inhalation of the dose of the powdered medicament contained in the dosing recess (11); a casing (4) having a corresponding window (23), in which the container (8), the intake channel (9) and the metering device (10) are housed, the casing (4) being at least partially visible through the window (23); Equipped with the powder inhaler (2) is adapted to be attached to an electronic module (3) comprising an optical proximity sensor (29); A powder inhaler, wherein when the electronic module (3) is attached to the powder inhaler (2), the window (23) of the casing (4) faces a window (27) of the housing (24) of the electronic module (3) such that the optical proximity sensor (29) faces at least a part of the metering device (10) to detect the position of the at least a part of the metering device (10) and at least detects when the metering device (10) is in the trigger state, and the optical proximity sensor (29) is arranged and configured to detect the position of the shuttle (13) and the position of the protective member (14).

Images