Electronic module for an inhaler and inhaler assembly comprising an electronic module - Patents.com

Abstract

The electronic module for the inhaler includes a printed circuit board (24) and electronic components (25, 26, 27) configured to detect at least a status and / or at least an operating parameter of the inhaler (2) when the electronic module (3) is attached to the inhaler (2). A battery (28) is permanently attached to the printed circuit board (24). The first terminal (33) and the second terminal (34) are electrically connectable from one to the other by a main switch (100) to close a circuit between the battery (28) and the electronic components (25, 26, 27). In a rest configuration, the first and second terminals (33, 34) are electrically isolated from one another by the main switch (100). In an operating configuration, the first terminal (33) and the second terminal (34) are electrically connected from one to the other by the main switch (100).

Description

[Technical field]

[0001] The present invention describes an electronic module for an inhaler and relates to an assembly comprising an inhaler and an electronic module. The inhaler is preferably a device for delivering a powdered medicament formulation by inhalation. The device is in particular a portable, multi-dose, breath-activated dry powder inhaler without propellant gas, equipped with a metering device for delivering doses from a medicament container. The electronic module is configured to detect at least a status and / or at least an operating parameter of the inhaler, and possibly to perform 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 function, thereby avoiding unintended dosing. Nowadays, every user has an electronic device, such as a computer, a smartphone or a tablet, which can be used in daily life and has applications that can be useful for managing the administration of medicines. WO 2016 / 000983, a document by the same applicant, discloses a powder inhaler similar to that of WO 2004 / 012801.

[0005] The powder inhalers of WO 2004 / 012801 and of WO 2016000983 do not include any electronic devices for interfacing with external electronic devices.

[0006] Inhalers are also known which are provided with electronic devices arranged to detect actuation of the inhaler itself and / or to collect data.

[0007] The document EP 2414978 discloses a reusable and portable communication device that can be attached to an electronic drug delivery device, such as an electronic drug inhaler. The communication device may include a battery for powering the device. The battery may be a disposable battery or a rechargeable battery.

[0008] The document EP 3113817 discloses a compliance monitoring device for a dry powder drug delivery device. The compliance monitoring device includes a first part for receiving and / or holding a base part of the drug delivery device and a second part for releasably securing the drug delivery device to the first part. The compliance monitoring device may be powered by a battery (rechargeable or replaceable), a kinetic charger, or by solar power.

[0009] The document WO2017178865 discloses an add-on device for a metered dose inhaler. The add-on device comprises an observation system housing component comprising an observation system having at least one pressure sensor. The observation system allows to register certain predefined events. The device comprises a power source, for example a removable and / or rechargeable battery.

[0010] The use of rechargeable batteries as described in some of the documents above implies the adoption of a battery charger, which may increase the cost of the device.

[0011] The use of replaceable batteries as described in some of the other documents above means that the connections between the battery and the device, such as the contacts of the printed circuit board, do not provide a robust power source against mechanical forces, such as those that occur during dropping the device or various shocks and vibrations. In fact, commonly used battery holders that allow the removal and reinsertion of battery cells are prone to deformation during shocks and mechanical disturbances, thus causing interruptions in the supply of power from the battery to the electronic circuitry (when the battery temporarily loses contact with the battery holder and / or the printed circuit board). These power interruptions cause the electronic control unit of the known device to be reset, which may cause persistent software failures depending on the internal state of the control unit at the time its power was lost.

[0012] The document US5505195 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 a 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 a main battery for primary power to the device and an additional battery for powering the ram memory in case the main battery is ever removed or the main battery is nearly depleted of energy. The redundant power supply in US5505195 is not cost effective. Summary of the Invention

[0013] SUMMARY OF THE PRESENT EMBODIMENT An object of the present invention is to overcome the above-mentioned drawbacks of electronic modules for inhalers known hitherto.

[0014] In particular, it is an object of the present invention to provide an electronic module for an inhaler having a power supply that is robust against mechanical forces and therefore prevents power failures.

[0015] It is also an object of the present invention to provide an electronic module for an inhaler that makes it possible to maintain the battery at least between the manufacture of the device and its first use, i.e. during long-term storage of the device before it is sold.

[0016] A further object of the present invention is to minimize the power load placed on the battery during long term storage.

[0017] At least one of the above objects is substantially achieved by an electronic module for an inhaler and for an inhaler assembly as set forth 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, there is provided an electronic module for an inhaler, the electronic module being attached or attachable to the inhaler, the electronic module comprising: a printed circuit board comprising electronic components configured to detect at least a status and / or at least an operating parameter of the inhaler when the electronic module is attached to the inhaler; at least one battery permanently attached to the printed circuit board; Equipped with the printed circuit board includes a first terminal and a second terminal electrically connectable from one to the other by a main switch to close a circuit between the battery and the electronic component to energize the electronic component; In a rest configuration of the electronic module, the first terminal and the second terminal are electrically isolated by a main switch; In an operational configuration of the electronic module, the first terminal and the second terminal are electrically connected from one to the other by the main switch, and the electronic module includes a latch circuit operatively electrically interposed between the battery and the electronic component, the latch circuit being configured to maintain power supply to the electronic component during a momentary disconnection of the first terminal from the second terminal due to a fault in the main switch when the electronic module is in the operational configuration.

[0020] In one embodiment according to the first aspect, the electronic module optionally comprises a removable electrically insulating pull tab, the main switch comprises at least one spring-loaded contact, in a resting configuration of the electronic module the first terminal and the second terminal are electrically isolated by the removable electrically insulating pull tab, and in an operating configuration of the electronic module the removable electrically insulating pull tab is removed and the first terminal and the second terminal are electrically connected one to the other by the at least one spring-loaded contact, and the latch circuit is configured to maintain power supply to the electronic component during momentary disconnection of the first terminal from the second terminal due to shock and / or vibration causing a temporary loss of the spring-loaded contact.

[0021] According to a second independent aspect, there is provided an electronic module for an inhaler, the electronic module being attached or attachable to the inhaler, the electronic module comprising: a printed circuit board comprising electronic components configured to detect at least a status and / or at least an operating parameter of the inhaler when the electronic module is attached to the inhaler; at least one battery permanently attached to the printed circuit board; Equipped with the printed circuit board includes a first terminal and a second terminal electrically connectable from one to the other by at least one spring-loaded contact to close a circuit between the battery and the electronic component to energize the electronic component; the electronic module includes a removable electrically insulated pull tab; In a rest configuration of the electronic module, the first terminal and the second terminal are electrically isolated by a removable electrically insulating pull tab; In an operational configuration of the electronic module, the removable electrically insulative pull tab is removed and the first terminal and the second terminal are electrically connected one to the other by the at least one spring-loaded contact.

[0022] In one embodiment according to the second aspect, the electronic module optionally comprises a latch circuit operatively and electrically interposed between the battery and the electronic component, wherein when the electronic module is in an operational configuration, the latch circuit is configured to maintain electrical current to the electronic component during momentary disconnection of the first terminal from the second terminal due to shock and / or vibration causing a momentary loss of the spring-loaded contact.

[0023] In a third independent aspect, an inhaler assembly includes: An inhaler; An electronic module according to any of the preceding aspects or according to one or more of the following aspects; Equipped with The electronic module is attached or configured to be removably attached to the inhaler, and the electronic module is configured to detect at least a status and / or at least an operating parameter of the inhaler when the electronic module is attached to the inhaler.

[0024] The applicant has confirmed that the invention makes it possible to prevent a power failure of the electronic module due to a failure of the main switch (e.g. of said at least one spring-loaded contact) and a subsequent interruption of the electrical contact between the battery(ies) and the printed circuit board when the electronic module is in operation. Indeed, since the battery is permanently bonded to the printed circuit board, a momentary failure of the main switch, e.g. due to shock and / or vibration, cannot cause a loss of contact. In this specification and in the appended claims, the term "permanently connected" means that the battery cannot be removed from the printed circuit board without breaking the physical contact.

[0025] In particular, the applicant has determined that the latch circuit is capable of preventing disconnection of the power supply from the battery to the electronic components of the electronic module if at least one spring-loaded contact is temporarily lost during mechanical shock and vibration.

[0026] The use of this latching load switch circuit design provides a solution that minimizes the power consumption of the electronic module during its storage life while ensuring that the power supplied from the battery is robust against mechanical shock and vibration. The applicant has determined that the present invention makes it possible to preserve the battery and minimize the power load placed on the battery during long-term storage. In fact, a removable, electrically insulating pull tab, inserted into the electronic module during manufacture and removed by the user before first use, prevents connection between the battery and the electronic circuitry of the printed circuit board and preserves battery life during long-term storage.

[0027] In one aspect, the electronic module is removably attachable to the powder inhaler, optionally via a clip-on coupling, such that coupling and uncoupling is 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] The electronic module is intended to be provided separately from the inhaler and to be assembled by the user upon first use.

[0030] In one aspect, the removable electrically insulating pull tab, once removed, cannot be inserted back to separate the first terminal from the second terminal.

[0031] In one aspect, the removable electrically insulative pull tab is disposable.

[0032] In one aspect, the latch circuit comprises a load switch.

[0033] In one aspect, the load switch has an input, an output, and an enable input.

[0034] In one embodiment, the first terminal is electrically connected to the battery and to the input.

[0035] In one embodiment, the second terminal is electrically connected to the enable input.

[0036] In one aspect, the electronic component is electrically connected to the output.

[0037] In one aspect, the load switch includes a feedback path electrically connecting an output of the load switch to an enable input of the load switch.

[0038] In one aspect, the feedback path comprises passive or active components.

[0039] In one aspect, the passive component is a feedback resistor.

[0040] In one embodiment, the feedback resistor is greater than 50 kOhm.

[0041] In one embodiment, the feedback resistor is less than 150 kOhm.

[0042] In one embodiment, the feedback resistor is greater than 80 kOhm.

[0043] In one embodiment, the feedback resistor is less than 120 kOhm.

[0044] In one embodiment, the passive component is a diode.

[0045] In one aspect, the active component is a microcontroller or processing circuit.

[0046] In one aspect, the latch circuit provides isolation of the battery from the electronic components when the electronic module is in a resting configuration.

[0047] In one aspect, when the main switch is on or the removable electrically insulating pull tab is removed and the first terminal and the second terminal are electrically connected from one to the other, the load switch is enabled and electrically connects the input to the output to power the electronic component.

[0048] In one aspect, during a momentary disconnection of the first terminal from the second terminal due to a fault in the main switch or in the spring-loaded contacts, e.g., due to shock and / or vibration, the signal in the feedback path is configured to keep the load switch enabled and to keep the electronic component energized.

[0049] In one aspect, the load switch has a quiescent current that is comparable to a self-discharge rate of the at least one battery.

[0050] In one embodiment, the quiescent current is less than 2 μA, optionally less than 1 μA.

[0051] Applicants have determined that the load switch adds minimal additional energy demand to the system.

[0052] In one embodiment, at least one battery is soldered to a printed circuit board, optionally using through-hole mounted tabs.

[0053] In one aspect, the at least one battery comprises a plurality of batteries, optionally a battery pack.

[0054] In one aspect, the batteries are permanently joined together, optionally welded together, optionally using metal tabs.

[0055] Soldering and / or welding ensures a safe and robust electrical contact.

[0056] In one embodiment, the at least one battery is non-rechargeable.

[0057] The electronic module is disposable and once at least one battery is discharged, the electronic module is not reusable.

[0058] In one aspect, the removable electrically insulative pull tab is made from plastic.

[0059] In one aspect, the removable electrically insulating pull tab is a film.

[0060] In one aspect, the removable electrically insulating pull tab comprises an isolation portion that electrically isolates or is configured to electrically isolate the first terminal from the second terminal.

[0061] In one aspect, a removable electrically insulating pull tab comprises a portion configured to be manually grasped to enable removal of said removable electrically insulating pull tab.

[0062] In one aspect, an electronic module includes a housing.

[0063] In one aspect, the printed circuit board is disposed inside the housing.

[0064] In one aspect, the removable electrically insulating pull tab has a portion that protrudes from the housing to allow for manual removal of the removable electrically insulating pull tab.

[0065] In one aspect, the removable electrically insulating pull tab has an easy thumb grip area for ease of removal.

[0066] In one aspect, the at least one spring loaded contact comprises a metallic spring.

[0067] In one aspect, in a rest configuration of the electronic module, a removable, electrically insulating pull tab is interposed between the metal spring and the first and second terminals.

[0068] In one aspect, in an operational configuration of the electronic module, the metal spring is resiliently held against the first terminal and the second terminal, electrically connects the first terminal to the second terminal, and can momentarily disconnect from the first terminal and / or from the second terminal due to said shock and / or vibration.

[0069] In one embodiment, the first and second terminals are pads, optionally copper pads, on a printed circuit board.

[0070] In one embodiment, the metal spring is a metal leaf having a first end bonded to a printed circuit board or to a housing of an electronic module and a second end resiliently held against the first and second terminals.

[0071] In one embodiment, the main switch is a magnetic switch or an optical switch or a relay or an optocoupler or a touch switch.

[0072] In one aspect, the electronic components comprise an electronic control unit, optionally a microprocessor, and at least one sensor operatively connected to the electronic control unit and configured to detect said at least a status and / or said at least an operating parameter of the inhaler.

[0073] In one aspect, the electronic component comprises a storage memory.

[0074] In one aspect, the electronic component comprises a communication interface, optionally a wireless communication interface, optionally a Bluetooth® communication interface.

[0075] In one aspect, the communication interface is configured to connect the electronic module to an external electronic device, such as a computer, a smartphone, a tablet, etc. All operational parameters and data of the inhaler detected via the electronic module may be transferred to the external electronic device.

[0076] In one aspect, the electronic module includes a button switch operatively connected to the wireless communication interface for initiating pairing of the electronic module with the external electronic device.

[0077] In one aspect, the button switch is the main switch or is operatively connected to the main switch such that a transition of the electronic module from a dormant configuration to an operational configuration is triggered via the button switch.

[0078] In one embodiment, the inhaler is a powder inhaler.

[0079] In one aspect, the inhaler comprises a container for storing the powdered medicament.

[0080] 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.

[0081] In one aspect, the inhaler comprises a mouthpiece and an inhalation channel connected to the mouthpiece.

[0082] In one aspect, the inhaler comprises a metering device having a dosing recess.

[0083] In one aspect, the metering device is 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.

[0084] In one aspect, the electronic components of the electronic module comprise a sensor positioned and configured to sense the position of at least a portion of the metering device when the electronic module is attached to the inhaler to at least detect when the metering device is in a triggered state.

[0085] In one aspect, the sensor is a non-contact sensor, optionally an optical proximity sensor.

[0086] In one aspect, the optical proximity sensor operates in the near infrared spectrum.

[0087] In one aspect, the sensor is powered by said at least one battery.

[0088] In one aspect, the powder inhaler comprises a casing, optionally a plastic casing, and the electronic module comprises a housing, optionally a plastic housing.

[0089] 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.

[0090] In one aspect, the container, the intake channel, and the metering device are housed in a casing.

[0091] In one aspect, the casing has a corresponding window and the housing has a corresponding window.

[0092] 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 sensor faces at least a portion of the metering device.

[0093] In one aspect, the sensor is disposed within the housing.

[0094] 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.

[0095] In one aspect, the electronic control unit comprises: - reading an output signal from the non-contact sensor at regular intervals; - optionally filtering 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

[0096] In one aspect, the inhaler comprises a casing and a cover rotatably coupled to the casing.

[0097] In one aspect, the electronics module is attached or attachable to a portion of the inhaler opposite the cover.

[0098] 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.

[0099] In one aspect, the electronic module comprises a cover open switch configured to detect the opening of the cover of the inhaler.

[0100] In one aspect, the cover opening switch is operatively connected to the electronic control unit.

[0101] In one aspect, the cover opening switch is mounted on a printed circuit board.

[0102] In one embodiment, the cover opening switch is powered by the at least one battery.

[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 optionally causes activation of a non-contact sensor.

[0104] In one aspect, the cover opening switch is the main switch or is operatively connected to the main switch such that the transition of the electronic module from a dormant configuration to an operational configuration is triggered via the cover opening switch.

[0105] In one aspect, the electronic module includes an attachment detection switch that interacts with the inhaler when the electronic module is attached to the inhaler to detect connection or disconnection of the electronic module to / from the inhaler.

[0106] In one aspect, the attachment detection switch is operatively connected to the electronic control unit.

[0107] In one aspect, the attachment detection switch is mounted on a printed circuit board.

[0108] In one aspect, the attachment detection switch is powered by the at least one battery.

[0109] In one aspect, attachment of the electronic module to the inhaler triggers an attachment detection switch, which optionally causes activation of a cover open switch.

[0110] In one aspect, the attachment detection switch is the main switch or is operatively connected to the main switch such that the transition of the electronic module from the dormant configuration to the operational configuration is triggered via the attachment detection switch.

[0111] In one embodiment, the electronic control unit is configured to store data relating to inhaler events, 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 the cover, in a storage memory and / or to transmit to an external electronic device via a communication interface.

[0112] 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 electronic device.

[0113] In one aspect, the electronic control unit is configured to send said data to an external electronic device upon request. While a connection with an external electronic 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 electronic device to operate properly and save data. [Brief description of the drawings]

[0114] [Figure 1]FIG. 1 is an isometric view of an inhaler assembly including an inhaler and an electronic module according to the present invention in a closed configuration. [Diagram 2] FIG. 2 is an isometric view of the inhaler assembly of FIG. 1 in an open configuration. [Diagram 3] 3 is an isometric view of an embodiment of an electronics module of the inhaler assembly of FIGS. 1 and 2 prior to use, with an isolation pull tab inserted. FIG. [Figure 4] FIG. 3 is another isometric view of the electronics module of the inhaler assembly of FIGS. 1 and 2. [Diagram 5] FIG. 2 is a cross-sectional view of the inhaler assembly of the previous figure with the cover closed. [Figure 6] FIG. 2 is a cross-sectional view of the inhaler assembly of the previous figure with the cover open; [Figure 7] FIG. 2 is an isometric view of the printed circuit board of the electronic module of the previous figure. [Figure 8] 8 is another isometric view of the printed circuit board embodiment of FIG. 7 with an isolation pull tab inserted. [Figure 9] FIG. 9 is an enlarged portion of the printed circuit board of FIGS. 7 and 8. [Figure 10] FIG. 2 is a diagram of a portion of an electronic module with some components removed and in a first configuration. [Figure 11] FIG. 11 shows the portion of FIG. 10 in another configuration. [Figure 12] FIG. 12 is a block diagram of a portion of the printed circuit board of FIGS. 7 to 11. [Figure 13] FIG. 12 is an electrical diagram of a portion of the printed circuit board of FIGS. 7 to 11. [Figure 14] FIG. 13 is a block diagram of an alternative embodiment of FIG. 12. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0115] With reference to the accompanying drawings, Figures 1 and 2 show an inhaler assembly 1 according to the invention. The 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. The electronic module 3 (additional module) is intended to be provided separately from the inhaler 2 and to be assembled by the user upon first use. For example, the electronics in the electronic module 3 are fully constructed and assembled at most two years before the first use in the field, thus requiring a minimum shelf life of 24 months before its use life is specified as a further 12 months.

[0116] powder inhaler The powder inhaler 2 shown in Figure 1 comprises a plastic casing 4 and a plastic cover 5 pivotally or rotatably connected to the casing 4. As shown in 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 for an air inlet.

[0117] 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 (Figure 5). 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 Figure 5.

[0118] 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. The metering device 10 is a mechanism comprising multiple moving components.

[0119] The metering device 10 is movable relative to the container 8 and relative to the inhalation channel 9 between an idle state (as shown in Figure 5), 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 (not shown in the accompanying figures), in which the dosing recess 11 is positioned below and 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.

[0120] 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 (FIG. 6). The filling position corresponds to the idle state of the metering device 10 (FIG. 5), 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 and triggered states 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 (FIG. 6).

[0121] The shuttle 13 is mechanically coupled to the cover 5 such that opening the cover 5 beyond the 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. For example, the range of rotational movement that causes the shuttle to slide from the fill position to the suction position is 80 degrees.

[0122] 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).

[0123] 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.

[0124] 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 of the protective member 14, as disclosed in Table 1 below. [Table 1] In the idle state, the shuttle 13 is in the filling 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 (Figure 5).

[0125] In the ready state, 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 powdered medicament contained in the dosing recess 11 from entering the inhalation channel 9 (Figure 6).

[0126] In the triggered state (not shown), 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 a user to inhale a dose of powdered medicament contained therein.

[0127] The powder inhaler 2 further comprises an inhalation or breath-activated mechanism 15 coupled to the protective member 14. The inhalation-activated mechanism 15 comprises an inhalation-activated member 16 shaped like a flap, a coupling member 17 and an elastic element, not shown. 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 approaches 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. In the second position, 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.

[0128] In order to move protective member 14 from a closed position to an open position when coupling member 17 moves from its respective first position to its respective second position and vice versa, coupling member 17 is provided with an extension portion which engages with an opening 18 formed in protective member 14.

[0129] The casing 4 has an optically transparent window 19 disposed adjacent to the metering device 10 such that the metering device 10 is at least partially visible through the window 19 from outside the casing 4. In particular, the shuttle 13, the protective member 14 and the end of the connecting member 17 are visible through the window 19. The protective member 14 has a smooth surface finish that reflects light like a mirror (specular reflection), whereas the shuttle 13 and the extension reflect light more diffusely (scattered reflection). All elements of the powder inhaler 2 may be made of a plastic material.

[0130] 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.

[0131] The electronic module 3 comprises a plastic housing 20 which is removably attachable to the casing 4 of the powder inhaler via a clip-on connection. A non-limiting embodiment of the housing 20 of the electronic module 3 shown in the accompanying figures comprises a rigid clip 21 and a flexible clip 22 shaped to mate with respective recesses in the casing 4 of the powder inhaler 2.

[0132] The housing 20 has an upper surface that is configured to face the lower surface of the powder inhaler 2 having the optically transparent window 19 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 respective optically transparent window 23, and the window 19 of the casing 4 faces the window 23 of the housing 20 when the electronic module 3 is attached to the powder inhaler 2.

[0133] The interior of the housing 20 contains a printed circuit board (PCB) 24. The printed circuit board (PCB) 24 supports electronic components, one or more of which are configured to sense at least a status and / or at least an operating parameter of the dry powder inhaler 2 when the electronic module 3 is attached to the dry powder inhaler 2.

[0134] The electronic component comprises an electronic control unit (i.e. 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 electronic device, such as a computer, a smartphone, a tablet, etc. All operating parameters and data of the powder inhaler 2 detected via the electronic module 3 may be stored in the storage memory and / or transferred to the external electronic device.

[0135] The electronic component further comprises at least one sensor operatively connected to the electronic control unit, the sensor being configured to detect said at least a status and / or said at least an operating parameter of the inhaler.

[0136] In the non-limiting embodiment shown in the attached figures, the electronics of the electronic module 3 comprises an optical proximity sensor 25 operating in the near infrared spectrum. The optical proximity sensor 25 is arranged in the housing 20 and is arranged and configured to sense the position of at least a part of the metering device 10 when the electronic module 3 is attached to the powder inhaler 2, and to at least detect when the metering device 10 is in a triggered state. Indeed, when the electronic module 3 is attached to the powder inhaler 2, the window 19 of the casing 4 faces the window 23 of the housing 20, as shown in Figure 5, such that the optical proximity sensor 25 faces at least a part of the metering device 10. The microprocessor may be configured to carry out the tasks including at least the steps of reading the output signal from the optical proximity sensor 25 at regular intervals, filtering the output, and comparing the output to a threshold value to identify whether the metering device 10 is in a triggered state or not.

[0137] In the non-limiting embodiment shown in the accompanying figures, the electronic components of the electronic module 3 further comprise a cover open switch 26 and an installation detection switch 27. The cover open switch 26 and the installation detection switch 27 are mounted on a printed circuit board (PCB) 24 and are operatively connected to the microprocessor.

[0138] The cover opening switch 26 comprises a mechanical detector switch mounted on a printed circuit board (PCB) 24 and operatively connected to the microprocessor, and a spring-loaded mechanical part shaped as an arm 26a (FIGS. 7, 8, 9, 10 and 11). A portion of said arm 26a is disposed outside the housing 20 of the electronic module 3 so as to mechanically interact with the cover 5 of the dry powder inhaler 2 when the cover 5 is opened beyond the range of rotational movement of said cover 5 from the closed position. Opening the cover 5 beyond the range of rotational movement of said cover 5 from the closed position of said cover triggers the cover opening switch 26, which causes the activation of the optical proximity sensor 25.

[0139] The attachment detection switch 27 is a mechanical detector switch mounted on the printed circuit board (PCB) 24, operatively connected to the microprocessor, and includes pins (FIGS. 3 and 4) protruding from the top surface of the housing 20 through respective apertures to mechanically interact with the powder inhaler 2 when the electronic module 3 is attached to the powder inhaler 2. Attachment of the electronic module 3 to the powder inhaler 2 triggers the attachment detection switch 27, which allows monitoring of the cover open switch 26.

[0140] The microprocessor is configured to store data relating to events of the powder inhaler 2, such as triggering of the metering device 10, and / or attachment / detachment of the electronic module 3 to / from the powder inhaler 2, and / or opening / closing of the cover 5, in a storage memory and / or to transmit the data to an external electronic device via the communication interface.

[0141] The electronic module 3 comprises a pack of non-rechargeable batteries 28, e.g., two primary coin cells, permanently bonded to a printed circuit board 24. The batteries 28 of the pack are welded together via metal tabs 29 and soldered to the printed circuit board (PCB) 24 by through-hole mounted tabs 30 (FIG. 7). Because the batteries 28 are non-rechargeable and non-removable, the electronic module 3 is disposable, i.e., once the batteries 28 are discharged, the electronic module 3 is not reusable and must be ejected.

[0142] A pack of non-rechargeable batteries 28 is electrically connectable or connected to the electronic components and provides power to said electronic components via spring-loaded contacts 31 (FIGS. 8 and 9) and latch circuitry 32 (FIGS. 12, 13 and 14).

[0143] The printed circuit board (PCB) 24 comprises a first terminal 33 and a second terminal 34 (FIG. 9) defined by copper pads electrically connectable from one to the other by said spring-loaded contacts 31 to close a circuit between the battery 28 and the electronic component to energize the electronic component. The spring-loaded contacts 31 comprise a metal spring defined by a metal leaf having a first end bonded to the printed circuit board (PCB) 24 or to the housing 20 and a second end resiliently held against the first terminal 33 and the second terminal 34 (FIGS. 8 and 9).

[0144] During manufacture of the electronic module 3, a removable electrically insulating pull tab 35 is interposed between the metal leaf and the first and second terminals 33, 34 (FIG. 8). The removable electrically insulating pull tab 35 remains in place during long term storage of the electronic module 3 and until first use by a user. The removable electrically insulating pull tab 35 is made of a plastic film and comprises an isolation portion 36 configured to electrically isolate or electrically isolate the first terminal 33 from the second terminal 34, and a portion 37 having an easy thumb grip area and configured to be grasped to allow removal of the removable electrically insulating pull tab 35.

[0145] The removable electrically insulating pull tab 35 is removed by the user prior to first use and before attaching the electronic module 3 to the inhaler 2, and the removable electrically insulating pull tab 35 is in place.

[0146] In the rest configuration of the electronic module 3 (during long term storage and before first use), the isolation portion 36 is inserted and interposed between the metal leaf and the first and second terminals 33, 34. A portion 37 protrudes from the housing 20 to allow manual removal of said removable electrically insulating pull tab 35.

[0147] In the operational configuration of the electronic module 3 (after initial use, when the removable electrically insulative pull tab 35 has been removed), the metal spring is resiliently held against the first terminal 33 and the second terminal 34, electrically connecting the first terminal 33 to the second terminal 34. The metal spring shorts to contacts on the printed circuit board 24, which then begins to energize the remainder of the circuit.

[0148] Since the described electrical contact is provided by the resilient force of a metal spring, shock and / or vibration may accidentally and momentarily disconnect the first terminal from the second terminal. Thus, in the disclosed embodiment, the electronic module 3 includes a latch circuit 32 operatively and electrically interposed between the battery 28 and the electronic components.

[0149] The latch circuit 32 is configured to maintain electrical current to the electronic component during an accidental and momentary disconnection of the first terminal 33 from the second terminal 34 due to shock and / or vibration.

[0150] The latch circuit 32 includes a load switch 38 having an input 39 electrically connected to the first terminal 33 and the battery 28, an output 40 electrically connected to the electronic components 25, 26, 27, and an enable input 41 electrically connected to the second terminal 34 (FIG. 13). A feedback path 42 having a 100 kOhm feedback resistor 43 electrically connects the output 40 of the load switch 38 to the enable input 41 of the load switch 38. The load switch 38 has a quiescent current of less than 1 μA, which is compatible with the self-discharge rate of the battery 28.

[0151] In the rest configuration of the electronic module 3 (during long term storage and before first use), a removable electrically insulating pull tab 35 keeps the battery 28 disconnected from the enable input 41 of the load switch 38. The load switch 38 is not enabled (input 39 and output 40 are electrically disconnected) providing isolation of the electronic components 25, 26, 27 from the battery 28. The load switch 38 adds minimal additional energy demand to the system.

[0152] When the removable electrically insulating pull tab 35 is removed and the first terminal 33 and the second terminal 34 are electrically connected from one to the other to form a circuit between the battery 28 and the load switch enable input 41 (the operational configuration of the electronic module 3), the load switch 38 is enabled and electrically connects the input 39 to the output 40 to energize the electronic components 25, 26, 27.

[0153] In an operational configuration of the electronic module, during an accidental momentary disconnection of the first terminal from the second terminal due to shock and / or vibration, when the metal spring is deflected away from the printed circuit board 28, the signal in the feedback path 42 is configured to keep the load switch 38 enabled and to keep the electronic components 25, 26, 27 energized. The on / off signal at the enable input 41 of the load switch 38 remains high, thus preventing disconnection of the power supply.

[0154] In another embodiment of the electronic module 3, the first terminal 33 and the second terminal 34 are electrically isolated by a main switch 100 (schematically shown in Figs. 12 and 14) that is different from the spring-loaded contacts 31 and the removable electrically insulating pull tab 35. The main switch 100 is used to release the electronic device 3 from a storage mode. The latch circuit 32 is configured to maintain power supply to the electronic components 25, 26, 27 during a momentary disconnection of the first terminal 33 from the second terminal 34 due to a failure of the main switch 100. When the main switch 100 is on, the first terminal 33 and the second terminal 34 are electrically connected from one to the other, and the load switch 32 is enabled and electrically connects the input 39 to the output 40 to power the electronic components 25, 26, 27. During a momentary disconnection of the first terminal 33 from the second terminal 34 due to a fault in the main switch 100, the signal in the feedback path 42 is configured to keep the load switch 100 enabled and to keep the electronic components 25, 26, 27 energized. The main switch 100 may be a magnetic switch or an optical switch or a relay or an optocoupler or a touch switch.

[0155] In the embodiment of Figure 13, the feedback is realized as a resistor 43. Depending on the topology of the load switch 38, other passive components such as diodes can be used. Also, active processing methods can be used, such as a general purpose microcontroller or hardware processing circuitry.

[0156] According to Fig. 12, the main switch 100 connects the battery 28 to the enable input 41 of the load switch 38, as in Fig. 13. When enabled, the system current flows through the load switch 38 and substantially not through the main switch 100 itself. According to Fig. 14, the main switch 100 is used as a parallel path for the flow of system current. In this case, the system current flows through both the main switch 100 and the load switch 38 when enabled.

[0157] In some other embodiments, the cover open switch 26 or the attachment detection switch 27 may be configured to release the electronic device 3 from the storage mode. The cover open switch 26 or the attachment detection switch 27 may be the main switch 100 or may be operatively connected to the main switch 100 such that a transition of the electronic module 3 from a dormant configuration to an operational configuration is triggered via the cover open switch 26 or the attachment detection switch 27.

[0158] In some other embodiments, the electronic module 3 comprises a button switch, not shown in the accompanying figures, operatively connected to the wireless communication interface for initiating pairing of the electronic module 3 with an external electronic device. This button switch is the main switch 100 or is operatively connected to the main switch 100 such that the transition of the electronic module 3 from a resting configuration to a working configuration is triggered via said button switch.

[0159] When the cover opening switch 26 or the installation detection switch 27 or the button switch operates as a main switch and is configured to enable the load switch 38, an interface circuit may be present and is electrically connected to the latch circuit 32 and the cover opening switch 26 or the installation detection switch 27 or the button switch.

Claims

1. 1. An electronics module for an inhaler, said electronics module being attached or attachable to said inhaler, said electronics module comprising: a printed circuit board (24) comprising electronic components (25, 26, 27), said electronic components (25, 26, 27) configured to detect at least a status and / or at least an operating parameter of said inhaler (2) when said electronic module (3) is attached to said inhaler (2); at least one battery (28) permanently attached to said printed circuit board (24); Equipped with the printed circuit board (24) comprises a first terminal (33) and a second terminal (34) electrically connectable from one to the other by a main switch (100) to close a circuit between the battery (28) and the electronic components (25, 26, 27) and energize the electronic components (25, 26, 27); In a rest configuration of the electronic module (3), the first terminal (33) and the second terminal (34) are electrically isolated by the main switch (100); In an operational configuration of the electronic module (3), the first terminal (33) and the second terminal (34) are electrically connected from one to the other by the main switch (100), and the electronic module:

1. An electronic module comprising: a latch circuit (32) operatively and electrically interposed between the battery (28) and the electronic components (25, 26, 27), the latch circuit (32) being configured to maintain power supply to the electronic components (25, 26, 27) during a momentary disconnection of the first terminal (33) from the second terminal (34) due to a fault in the main switch (100) when the electronic module (3) is in the operational configuration.

2. The latch circuit (32), a load switch (38) having an input (39), an output (40), and an enable input (41), the first terminal (33) being electrically connected to the battery (28) and the input (39), the second terminal (34) being electrically connected to the enable input (41), and the electronic components (25, 26, 27) being electrically connected to the output (40); a feedback path (42) electrically connecting the output (40) of the load switch (38) to the enable input (41) of the load switch (38); Equipped with when the main switch (100) is on and the first terminal (33) and the second terminal (34) are electrically connected from one to the other, the load switch (38) is enabled and electrically connects the input (39) to the output (40) to energize the electronic components (25, 26, 27); 2. The electronic module of claim 1, wherein during a momentary disconnection of the first terminal from the second terminal, a signal in the feedback path is configured to keep the load switch enabled and to keep the electronic components energized.

3. 3. The electronic module of claim 1, wherein the main switch comprises at least one spring-loaded contact, wherein in the resting configuration of the electronic module, the first terminal and the second terminal are electrically isolated by the removable, electrically insulating pull tab, and in the operating configuration of the electronic module, the removable, electrically insulating pull tab is removed and the first terminal and the second terminal are electrically connected one to the other by the at least one spring-loaded contact, and wherein the latch circuit is configured to maintain power supply to the electronic components during momentary disconnection of the first terminal from the second terminal due to shock and / or vibration causing a temporary loss of the spring-loaded contact.

4. 3. The electronic module of claim 1, further comprising: a wireless communication interface configured to connect the electronic module to an external electronic device; and a button switch operatively connected to the wireless communication interface to initiate pairing of the electronic module with the external electronic device, the button switch being the main switch or operatively connected to the main switch such that a transition of the electronic module from the rest configuration to the operating configuration is triggered by the button switch.

5. 3. The electronic module of claim 1 or 2, further comprising a cover opening switch (26) configured to detect an opening of a cover (5) of the inhaler (2), the cover opening switch (26) comprising: a mechanical detector switch mounted on the printed circuit board (24) and operatively connected to an electronic control unit; and a spring-loaded mechanical component configured to mechanically interact with the cover (5) of the inhaler (2) when the cover (5) is opened, the opening of the cover (5) of the inhaler (2) triggering the cover opening switch (26), the cover opening switch (26) being the main switch (100) or operatively connected to the main switch (100) such that a transition of the electronic module (3) from the rest configuration to the operating configuration is triggered by the cover opening switch (26).

6. An electronic module as described in claim 1 or 2, comprising an attachment detection switch (27) configured to detect connection or disconnection of the electronic module (3) to / from the inhaler (2), the attachment detection switch (27) being a mechanical detector switch mounted on the printed circuit board (24) and operatively connected to an electronic control unit, the attachment detection switch (27) comprising a pin configured to mechanically interact with the inhaler (2) when the electronic module (3) is attached to the inhaler (2), and the attachment detection switch (27) being the main switch (100) or operatively connected to the main switch (100) such that a transition of the electronic module (3) from the rest configuration to the operating configuration is triggered by the attachment detection switch (27).

7. The electronic module according to claim 2 or any one of claims 3 to 6 depending on claim 2, wherein the feedback path (42) comprises a passive component or an active component.

8. 8. The electronic module of claim 2 or any one of claims 3 to 7 dependent on claim 2, wherein the load switch (38) has a quiescent current that is comparable to a self-discharge rate of the at least one battery (28).

9. 9. The electronic module of claim 8, wherein the quiescent current is less than 2 μA.

10. The electronic module of any one of the preceding claims, wherein the at least one battery (28) is soldered to the printed circuit board (24).

11. Electronic module according to any one of the preceding claims, wherein the at least one battery (28) is non-rechargeable.

12. An electronic module according to claim 3 or any one of claims 7 to 11 when dependent on claim 3, wherein the removable, electrically insulating pull tab (35) is made of plastic.

13. 13. An electronic module according to claim 3 or any one of claims 7 to 12 when dependent on claim 3, wherein the electronic module (3) comprises a housing (20), the printed circuit board assembly (24) is disposed inside the housing (20), and the removable, electrically insulating pull tab (35) has a portion (37) that protrudes from the housing (20) to enable manual removal of the removable, electrically insulating pull tab (35).

14. 14. The electronic module according to claim 3 or any one of claims 7 to 13 when dependent on claim 3, wherein the at least one spring-loaded contact (31) comprises a metal spring, and in the rest configuration of the electronic module (3), the removable, electrically insulating pull tab (35) is interposed between the metal spring and the first terminal (33) and the second terminal (34), and in the operating configuration of the electronic module (3), the metal spring is elastically held against the first terminal (33) and the second terminal (34) and electrically connects the first terminal (33) to the second terminal (34).

15. 1. An inhaler assembly comprising: An inhaler (2); An electronic module (3) according to any one of claims 1 to 14, Equipped with An inhaler assembly, wherein the electronic module (3) is attached or configured to be removably attached to the inhaler (2), and the electronic module (3) is configured to detect at least a status and / or at least an operating parameter of the inhaler (2) when the electronic module (3) is attached to the inhaler (2).

16. The 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 16. An inhaler assembly as claimed in claim 15, wherein the electronic components (25, 26, 27) of the electronic module (3) comprise a sensor (25) arranged and configured to sense the position of at least a part of the metering device (10) when the electronic module (3) is attached to the inhaler (2) and to detect at least when the metering device (10) is in the triggered state.

17. 17. An inhaler assembly according to claim 16, wherein the sensor (25) is an optical proximity sensor, the inhaler (2) comprises a casing (4), the electronic module (3) comprises a housing (20), the container (8), the inhalation channel (9) and the metering device (10) are housed in the casing (4), the casing (4) has a corresponding window (19) and the housing (20) has a corresponding window (23), and when the electronic module (3) is attached to the powder inhaler (2), the window (19) of the casing (4) faces the window (23) of the housing (20) such that the sensor (25) faces at least a part of the metering device (10).

Images