Electronic module for a metered dose inhaler and metered dose inhaler assembly comprising the electronic module

Abstract

An electronic module for a metered dose inhaler comprises a casing (10) having a front wall (13) configured to face a back side (6a) of a housing (6) of a metered dose inhaler (2), a back wall (16) opposite the front wall (13) and a side wall (17) extending between the front wall (13) and the back wall (16). An electronic unit (11) is installed inside the casing (10) and comprises a capacitive proximity device (29) having a capacitive sensor antenna (30). The capacitive sensor antenna (30) is placed against or close to an inner surface of the back wall (16) and / or the side wall (17) of the casing (10).

Description

[0001] “Electronic module for a metered dose inhaler and metered dose inhaler assembly comprising the electronic module”

[0002] DESCRIPTION

[0003] Technical field of the invention

[0004] The present invention relates to an electronic module for a metered dose inhaler (MDI) and to an assembly comprising a metered dose inhaler and the electronic module. The metered dose inhaler is a device for dispensing a medicament preparation by inhalation. The metered dose inhaler may be a pressurized metered dose inhaler (pMDI). The electronic module is provided with a capacitive proximity device capable of detecting several grip types of a user.

[0005] Background art

[0006] The administering of a medicament preparation by inhalation from an MDI or a pMDI is commonly known. MDI or pMDI inhalers comprising sensors and electronics to check the correctness and regularity of medication intake by the user are also known. The inhalers may include sensor / s and electronics or may be coupled to electronic modules comprising sensors and electronics configured to monitor the use.

[0007] Electronic devices attached to inhalers and capable of sensing the human touch are also known in the art.

[0008] Document US2016144141A1 discloses a detachable cap for measuring usage of an inhaler. The cap includes a hollow receiving portion adapted to removably receive the inhaler. An extension portion is provided for containing electronic components, including an electronic circuit comprising a controller coupled to a storage device and a power source. A capacitive touch film is embedded on the grooves for the finger at the top of the cap and is monitored by either dedicated capacitive touch sensor chipset or micro-controller. The capacitive touch sensor is always on, looking for an external human touch. Upon sensing the human touch, controller chipset turns the board on and then the microcontroller software differentiates between accidental touch or intentional inhaler use.

[0009] Document US2016256639A1 discloses a usage monitoring device embodied as an attachment device configured to be selectively coupled to one of a variety of different inhalers. While operating in a low-power mode, a first sensor is monitored for a signal indicative of handling of the medicament dispenser by a user. In response to detecting such handling, the device exits the low-power mode and begins to monitor a second sensor for a signal indicative of dispensing of the medicament. The entire body of the attachment device for a dry powder inhaler may act as a capacitive sensor.

[0010] Document US2019224426A1 discloses devices and methods to detect or sense one or more parameters of a medicament device, like shake parameters, actuation parameters or inhalation airflow parameters. A sensor device or sensor package is configured to be attached to a medicament device. The sensor device comprises a housing for containing the one or more sensors including touch sensors like an electrode, a capacitive or resistive touch sensor.

[0011] Document US2020155775A1 discloses a fluid dispenser device having a body provided with a mouthpiece, a fluid reservoir containing a fluid and a propellant gas and a metering valve including a valve member. The reservoir is mounted in the body to slide between a rest position in which the metering valve is closed and a dispensing position in which it is open to dispense a dose of fluid. The device includes a capacitive sensor provided on a distal end surface of the body receiving the electronic modules, so as to detect the pressure of the user’s fingers.

[0012] Document US2019125990 discloses a disposable usage-recording smart label for inhalers. The usage recording smart label comprises a capacitive touch sensing plate to detect the presence of an activating body organ such as a hand or finger. The usage recording smart label is adhered to the bottom surface and sidewalls of an MDI.

[0013] Summary

[0014] The Applicant realized that the devices of the prior art are not able to properly and easily discern between a grip of the user employed to pick and move the metered dose inhaler (MDI), for instance to put it in a bag or pocket or to move it from one place to another, and one of the specific grips, also defined by a protocol, for delivering a dose and inhaling the medicament.

[0015] The Applicant realized that the capacitive sensors or switches of the MDIs disclosed in documents US2016144141A1 , US2019224426A1 and US2020155775A1 are all positioned on the top of the canister to sense the pressure exerted by the tip of the finger of the user. Anyway, an unintentional pressure on the top portion may be also applied while handling the device to move it from one place to another and is not indicative of the user's intention to take a medicament dose. Indeed, the microcontroller of US2016144141A1 must make use of a flow sensor and of an accelerometer and an algorithm to differentiate between accidental touch and actual inhaler use.

[0016] The Applicant also realized that the capacitive sensors cited in document US2016256639A1 refer to a dry powder inhaler (not to an MDI) and that, if the entire body of the attachment device operates as a capacitive sensor, as disclosed in the description of US2016256639A1 , discerning between accidental touch and actual inhaler use is quite challenging.

[0017] It is an object of the present invention to eliminate the above drawbacks of hitherto known electronic modules for metered dose inhalers.

[0018] It is an object of the present invention to provide an electronic module for metered dose inhalers capable of discerning between accidental touch or generic handling and the actual use for medicament inhalation.

[0019] It is in particular object of the present invention to provide an electronic module for metered dose inhalers capable of understanding when the metered dose inhaler is gripped to actuate it, in particular for any grip actuation style adopted by the user.

[0020] It is also object of the present invention to provide an electronic module for metered dose inhalers understanding when the metered dose inhaler is going to be actuated in safe and reliable manner.

[0021] It is also object of the present invention to provide an electronic module for metered dose inhalers which can be woken up only when the user intends to use the inhaler. It is an object of the present invention to provide an electronic module for metered dose inhalers waking up sufficiently fast that the inhalation events detected through specific sensors will not be missed.

[0022] At least one of the above objects is substantially achieved by an electronic module for metered dose inhalers and to a meter dose inhaler assembly according to one or more of the appended claims and / or of the following aspects.

[0023] In accordance with a 1stindependent aspect, an electronic module for metered dose inhalers, comprises: a casing having: a front wall configured to face a back side of a housing of a metered dose inhaler when the electronic module is attached to said metered dose inhaler, the housing accommodating or being configured to accommodate a canister protruding from the housing, the canister being movable in the housing parallel to said back side, a back wall opposite the front wall, and a side wall extending between the front wall and the back wall; an electronic unit installed inside the casing; the electronic unit comprising a capacitive proximity device having a capacitive sensor antenna, the capacitive sensor antenna being placed against or close to an inner surface of the back wall and / or the side wall of the casing.

[0024] In accordance with a 2ndindependent aspect, a metered dose inhaler assembly comprises:

[0025] - a hollow body comprising: a housing accommodating or configured to accommodate a canister containing a drug formulation to be dispensed; a mouthpiece in fluid communication with the housing; a valve seat located in the hollow body, between the housing and the mouthpiece and accommodating or configured to accommodate a valve dispensing nozzle of the canister; the housing having an aperture delimited by a rim and a part of the canister protruding or being configured to protrude from said aperture; the metered dose inhaler being operated by pushing the part of the canister inside the housing;

[0026] - the electronic module according to the preceding aspect or to one or more of the following aspects.

[0027] The Applicant verified that the electronic module according to the invention is capable to detect the grip of the user indicating the intent to use the metered dose inhaler. Indeed, the position of the capacitive sensor antenna is such to detect substantially all style grips commonly used when the metered dose inhaler is grabbed with the intent to use it and inhale.

[0028] The Applicant verified that the electronic module according to the invention is able to perform the above detection in safe and reliable manner.

[0029] The Applicant verified that the capacitive proximity device implemented to carry out the above detection is relatively inexpensive and sensitive enough.

[0030] In an aspect, the electronic module is attached or is configured to be attached in removable manner to the metered dose inhaler.

[0031] In an aspect, the metered dose inhaler may be a pressurized metered dose inhaler. In an aspect, the capacitive sensor antenna is placed at a first end of the casing, said first end being configured to be placed close to a rim delimiting an aperture of the housing of the metered dose inhaler, the canister protruding from said aperture. In an aspect, the housing extends along a respective main axis and the mouthpiece protrudes laterally on a front side of the housing opposite a back side of said housing with respect to the main axis; the electronic module and the capacitive sensor antenna being placed on the back side.

[0032] In an aspect, the back wall and the side wall delimit a corner of the casing and the capacitive sensor antenna extends at least in part along said corner or parallel to said corner.

[0033] In an aspect, the side wall comprises a first end wall at the first end of the casing, a second end wall opposite the first end wall and two lateral walls joining the first end wall to the second end wall.

[0034] In an aspect, the capacitive sensor antenna is placed along a portion of the corner between the first end wall and the back wall.

[0035] In an aspect, the capacitive sensor antenna extends along portions of the corner between the lateral walls and the back wall.

[0036] In an aspect, the capacitive sensor antenna is elongated.

[0037] In an aspect, the electronic unit comprises a printed circuit board and the capacitive sensor antenna is fashioned on said printed circuit board.

[0038] In an aspect, the capacitive sensor antenna is implemented as a trace in the printed circuit board.

[0039] In an aspect, said trace is positioned to run close to the inside of the casing of the electronic module. This sensitizes one region of the casing of the electronic module to the touch of the user.

[0040] In an aspect, the capacitive sensor antenna is placed at least in part along an edge of the printed circuit board.

[0041] In an aspect, the printed circuit board comprises a portion having said edge and said edge is placed along the corner delimited by the back wall and the side wall or parallel to said corner.

[0042] In an aspect, said portion is attached to the back wall or placed side by side with the back wall or parallel to the back wall.

[0043] In an aspect, the electronic unit comprises a controller unit operatively connected to the capacitive proximity device. In an aspect, the capacitive proximity device is configured to detect, through the capacitive sensor antenna, the hand of a user grabbing the electronic module and to send a signal to the controller unit.

[0044] In an aspect, said signal is configured to wake up the controller unit from a sleep state and / or to activate at least one further sensor or at least one functionality of the electronic module.

[0045] The Applicant verified that the electronic module of the invention is able to wake up reliably the electronic unit of the module when touched by the user according to all styles of commonly used grips.

[0046] The Applicant verified that the electronic module of the invention allows to save power consumption of the power battery. Indeed, the other detection sensors and devices of the electronic module are relatively high power consumers if left enabled all the time. Therefore, such other detection sensors and devices are kept disabled and are enabled by the capacitive proximity device, which is a quite low power consumer. If the user’s hand comes close to, or contacts, the casing in this region, the capacitive proximity device asserts its touch output to issue a wake-up event to the electronic controller. This allows the inhalation and activation detection sensors and devices to be enabled, awaiting inhalation and activation events. If no such events occur within a timeout period, the electronic module may be placed back in a low-power sleep mode.

[0047] In an aspect, the electronic unit comprises at least one further sensor, for instance a pressure sensor or a flowmeter to sense flows of air in an air path of the assembly and inhalation, or an inductive sensor to detect position of the canister.

[0048] In an aspect, the electronic unit comprises an accelerometer.

[0049] In an aspect, the electronic unit is configured to execute the following procedure: waking up the controller unit from the sleep state and / or activating the at least one further sensor or functionality of the electronic module when receiving the signal from the capacitive proximity device; receiving an acceleration signal from the accelerometer qualifying readiness for use.

[0050] In an aspect, the acceleration signal from the accelerometer is indicative of an orientation of the electronic module and of the metered dose inhaler relative to the ground. In an aspect, the acceleration signal from the accelerometer is indicative of a stable angle of the electronic module and of the metered dose inhaler relative to the ground.

[0051] The capacitive proximity device responds to the touch of the user when the electronic module is touched prior to, or during, actuation of the metered dose inhaler device. This is used to wake the system from its low power, deep sleep mode. The accelerometer is used to monitor the attitude of the electronic module, and hence the metered dose inhaler device itself. This may be used to further qualify the wake-up event and also the attitude of the metered dose inhaler during inhalation events for adherence monitoring.

[0052] In a different aspect, the electronic unit is configured to execute the following procedure: powering the capacitive proximity device when receiving from the accelerometer an acceleration signal above a threshold; and then waking up the controller unit from the sleep state and / or activating the at least one further sensor or functionality of the electronic module when receiving the signal from the capacitive proximity device.

[0053] In an aspect, the casing is made of plastic.

[0054] In an aspect, the back wall is flat or substantially flat.

[0055] In an aspect, the capacitive sensor antenna is U-shaped.

[0056] In an aspect, the back wall has a rectangular outline with rounded edges.

[0057] In an aspect, said portion of the printed circuit board has substantially the same outline of the back wall.

[0058] In an aspect, the printed circuit board comprises an additional portion placed in the casing and parallel to said portion.

[0059] In an aspect, the portion and the additional portion are rigid, optionally made of fiberglass resin.

[0060] In an aspect, the portion and the additional portion are joined by a flexible part of the printed circuit board.

[0061] In an aspect, the printed circuit board carries a power battery.

[0062] In an aspect, the power battery is mounted on the portion.

[0063] In an aspect, the power battery is placed between the portion and the additional portion. This allows to improve the usage of space and to keep the electronic device compact.

[0064] In an aspect, the front wall of the casing is complementary to the back side of the housing, i.e. the front wall of the casing is shaped to match the back side of the housing.

[0065] In an aspect, the front wall of the casing is concave and the back side of the housing is convex.

[0066] In an aspect, the casing comprises at least one hook engaging or configured to engage the rim of the housing.

[0067] In an aspect, the at least one hook is located at the first end or close to the first end of the casing.

[0068] In an aspect, the casing comprises a projection, optionally an elastic projection, spaced from the at least one hook, the projection being configured to clip on the housing at a zone spaced from the rim of the housing.

[0069] In an aspect, the elastic projection is located at a second end of the casing opposite the first end.

[0070] In an aspect, the casing is elongated along a respective axis.

[0071] In an aspect, when the electronic module is attached to the metered dose inhaler, said respective axis is parallel to the main axis of the housing.

[0072] In an aspect, the second extremity of the housing comprises an elbow fashioned on an opposite side from the mouthpiece.

[0073] In an aspect, the projection of the casing is clipped on or is configured to clip on said elbow.

[0074] In an aspect, a lever is fashioned in the front wall and is coupled to a switch connected to the power battery, the lever engaging the back side of the housing when the electronic module is mounted on the metered dose inhaler, in order to connect the power battery to the electronic unit.

[0075] In an aspect, the lever and the switch are configured to connect the power battery to the electronic unit at the first use of the electronic module, i.e. first use after storage.

[0076] In an aspect, the switch remains depressed while the electronic module is attached to the metered dose inhaler.

[0077] In an aspect, the switch is configured to provide the electronic unit with a signal indicating the attachment of the electronic module to the metered dose inhaler. In an aspect, the switch is configured to hold electronically the connection of the power battery with electronic unit permanently after the first use.

[0078] The Applicant verified that the shelf life, i.e. the time the electronic module spends in storage prior to first use, is increased, since the power battery, while in storage, is fully disconnected from the electronic unit.

[0079] In an aspect, the lever is cut out in the front wall.

[0080] In an aspect, the lever has a proximal end integral with the front wall and a distal end interacting with the switch.

[0081] In an aspect, a part of the lever located between the proximal end and the distal end protrudes from the front wall to engage the back side of the housing when the electronic module is mounted on the metered dose inhaler.

[0082] In an aspect, the switch is on the printed circuit board, optionally on the additional portion of the printed circuit board facing the front wall of the casing.

[0083] In an aspect, the mouthpiece has a respective central axis.

[0084] In an aspect, the main axis and the central axis are skew with respect to each other such that the hollow body is L-shaped or substantially L-shaped.

[0085] In an aspect, the main axis and the central axis delimit an angle between 90° and 120°.

[0086] In an aspect, the hollow body is made of plastic.

[0087] In an aspect, the canister is made of metal.

[0088] Further features and advantages will be clearer from the detailed description of preferred but not exclusive embodiments of an electronic module for a metered dose inhaler and of a metered dose inhaler assembly according to the present invention.

[0089] Description of the drawings

[0090] Figures 1 and 2 show 3D views of a metered dose inhaler assembly comprising a metered dose inhaler and an electronic module according to the present invention;

[0091] Figures 3 and 4 show 3D views of the electronic module;

[0092] Figure 5 is an exploded view of the electronic module of figures 3 and 4;

[0093] Figure 6 shows a printed circuit board of the electronic module of the preceding figures;

[0094] Figure 7 is a further 3D view of the electronic module with transparent parts to show internal elements; Figure 8 is a schematic representation of electronic components of the electronic module;

[0095] Figure 9 shows various style grips of the metered dose inhaler;

[0096] Figure 10 is a block diagram of a procedure implemented by the electronic module; Figure 11 show graphs of a test carried out with the electronic module of the present invention.

[0097] Detailed description

[0098] With reference to the appended drawings, Figures 1 and 2 show a metered dose inhaler assembly 1 according to the present invention. The metered dose inhaler assembly 1 comprises a metered dose inhaler 2 (MDI) and an electronic module 3. The electronic module 3 is configured to be easily mounted on and dismounted from the metered dose inhaler 2 using no tools.

[0099] Metered dose inhaler

[0100] The metered dose inhaler 2 may be per se known and commercially available on the market. The metered dose inhaler 2 shown as example in Figures 1 and 2 comprises a hollow body 4, or actuator, and a canister 5 containing a drug formulation to be dispensed. The canister 5 is accommodated in the hollow body 4. The hollow body 4 comprises a housing 6 accommodating or configured to accommodate the canister 5 and a mouthpiece 7 which is in fluid communication with the housing 6. A valve seat, not shown in the appended drawings, is located in the hollow body 4 between the housing 6 and the mouthpiece 7. The housing 6, the mouthpiece 7 and the valve seat may be a single part of molded plastic.

[0101] The housing 6 is a sort of tubular element extending along a main axis “X-X”. The mouthpiece 7 is a sort of tubular element extending along a central axis “Y-Y”. The main axis “X-X” and the central axis “Y-Y” are skew with respect to each other, such that the hollow housing 6 is L-shaped or substantially L-shaped. The main axis “X- X” and the central axis “Y-Y” of the embodiment of the appended Figures delimit an angle of about 100° - 110°.

[0102] A first extremity of the housing 6 has an opening delimited by a rim 9. An opposite second extremity of the housing 6 is connected to the mouthpiece 7 and an elbow is fashioned on an opposite side from the mouthpiece 7. The canister 5 may be metallic, for instance produced in aluminum or stainless steel, and comprises a valve dispensing nozzle or metering valve, which may be per se known and is not shown. The drug formulation in the canister comprises a liquefied gas propellant (pressurized MDI) and, in many cases, stabilizing excipients.

[0103] When the canister 5 is accommodated in the housing 6 of the hollow body 4, like in Figures 1 and 2, the valve dispensing nozzle of the canister 5 is placed in the valve seat of the hollow body 4 and a part of the canister 5, opposite the valve dispensing nozzle, protrudes from the opening. A gap 8 is delimited between the canister 5 and the edge 9 and surrounds the canister 5.

[0104] In order to intake the medicament, the metered dose inhaler 2 is actuated by pushing the canister 5 towards the housing 6, i.e. by pressing the part of the canister 5 protruding from the gap 8. The canister 5 moves parallel to the main axis “X-X” and to the front side 6b and back side 6a of the housing 6.

[0105] This way, the valve dispensing nozzle is pressed in the valve seat and ejects the drug formulation. Meanwhile or just after pressing, the user draws from the mouthpiece 7, air enters the hollow body 4 through the gap 8 and flows in the mouthpiece 7 where air and drug medicament mix and are inhaled by the user through an opening in the mouthpiece 7.

[0106] Electronic module

[0107] The electronic module 3 is configured to be attached in removable manner to the metered dose inhaler 2, so that the same electronic module 3 may be used with another new metered dose inhaler once the medicament in the old metered dose inhaler is over.

[0108] The electronic module 3 comprises a casing 10, for instance a plastic casing, enclosing an electronic unit 11 and a power battery 12, for instance a lithium battery, connected to the electronic unit 11 to power said electronic unit 11 .

[0109] The electronic module 3 further comprises sensors operatively connected to the electronic unit 11 and configured to detect, for instance, manipulation by the user and / or actuation of the metered dose inhaler and / or proper inhalation and / or attachment of the electronic module 3 to the metered dose inhaler 2. The sensors may operate on an outer surface of the casing 10 or may be placed inside the casing 10. The electronic module 3 may comprise a signaling device, not shown, e.g. a led or a speaker, operatively connected to the electronic unit 11 and configured to alert the user (e.g. through a visual or audio signals) of the status and / or of the operation of the electronic module 3 and / or of the metered dose inhaler 2.

[0110] As shown in Figures 3 and 4, the casing 10 has a front wall 13 which is complementary to a back side 6a of the housing 6 of the hollow body 4 of the metered dose inhaler 2 opposite to a front side 6b from which the mouthpiece 7 protrudes. Said front wall 13 is concave to match the convex rounded side of the back side 6a of the housing 6.

[0111] The casing 10 is elongated along a respective axis “Z-Z” which, when the electronic module 3 is attached to the metered dose inhaler 2, is parallel to the main axis “X- X” of the housing 6. A first end of the casing 10 comprises a hooking assembly which protrudes from the front wall 13 and comprises two hooks 14. A second end of the casing 10, opposite the first end along the respective axis “Z-Z”, comprises an elastic projection 15.

[0112] The two hooks 14 are configured to engage the rim 9 of the housing 6 and the elastic projection 15 is configured to clip on the housing 6 at the elbow. When the electronic module 3 is clipped on the metered dose inhaler 2, said electronic module 3 is placed on the back side 6a.

[0113] The front wall 13, the two hooks 14 and the elastic projection 15 are part of a first molded part shown in figure 5.

[0114] The casing 10 comprises a second molded part shaped like a shell and comprising a back wall 16 (Figures 1 and 7), opposite the front wall 13, and a side wall 17 extending between the front wall 13 and the back wall 16.

[0115] The back wall 16 has a substantially rectangular outline with rounded edges and is flat or substantially flat.

[0116] The side wall 17 comprises a first end wall 18 defining or delimiting the first end of the casing 10, a second end wall 19, opposite the first end wall 18, and two lateral walls 20 joining the first end wall 18 to the second end wall 19.

[0117] In the embodiment shown in the appended Figures, the back wall 16 and the side wall 17 join each other at a corner 21 of the casing 10 which surrounds the back wall 16 and is chamfered.

[0118] The electronic unit 11 installed inside the casing 10 comprises a printed circuit board (PCB - laminated sandwich structure of conductive and insulating layers) of semi flexible type. The printed circuit board comprises a portion 22 and an additional portion 23 of rigid type, e.g. made of fiberglass resin. The portion 22 and the additional portion 23 are joined to each other by a flexible part 24 having flexible conductive paths connecting conductive paths and electronic components on the portion 22 and on the additional portion 23.

[0119] The portion 22 and the additional portion 23 are installed inside the casing 10 parallel to each other, as shown in Figure 5. The power battery 12 is installed on the portion 22 and, when the portion 22 and the additional portion 23 are properly lodged in the casing 10, the power battery 12 is placed between the portion 22 and the additional portion 23.

[0120] The portion 22 and the additional portion 23 carry a controller unit and other electronic components part of the electronic unit 11. The controller unit may be a Microcontroller MCU (schematically shown in Figure 8) comprising a CPU, flash and RAM memories, peripherals controllers, receiver / transmitter devices (such as BLE). The additional portion 23 may comprise an inductive sensor 25 shaped like an inductive coil operatively connected to the Microcontroller MCU through an analog- to-digital converter. The inductive sensor 25 may provide to the Microcontroller MCU signals correlated to positions and movement of the canister 5.

[0121] The portion 22 may carry a digital pressure sensor 26 operatively connected to the Microcontroller MCU. The digital pressure sensor 26 is in fluid connection with a pressure port 27 which, when the electronic module 3 is assembled, opens on the front wall 13 between the two hooks 14. The pressure sensor 26 may detect air flow through the gap 8 and may act like a flowmeter to sense inhalation.

[0122] The portion 22 or the additional portion 23 further comprises an accelerometer 28 (shown schematically in Figure 8) operatively connected to the Microcontroller MCU. The accelerometer 28 is configured to provide the Microcontroller MCU with signals correlated to position and / or orientation and / or motion of the electronic module 3. Also LEDs and switches may be mounted on or connected to the portion 22.

[0123] The electronic unit 11 further comprises a capacitive proximity device 29 having a capacitive sensor antenna 30 and a capacitive proximity detector 31 (Figure 8). The capacitive proximity detector 31 is operatively connected to the Microcontroller MCU.

[0124] The capacitive sensor antenna 30 is implemented as a trace in the printed circuit board. In the example embodiment of the attached Figures, the capacitive sensor antenna 30 is an elongated trace extending along an edge 32 of the portion 22. The portion 22 has substantially the same outline of the back wall 16, i.e. the shape of the edge 32 is similar to the shape of the corner 21 . When the printed circuit board is installed in the casing 10, the portion 22 is placed close to the back wall 16 and side by side with the back wall 16. In case LEDs are placed on a back of the portion 22 facing the back wall 16, between said portion 22 and the back wall 16, a light shield 33 may be positioned (shown in Figure 5).

[0125] When the printed circuit board is installed in the casing 10, the edge 32 extends parallel to the corner 21 and substantially all along said corner 21 . The edge 32 and the capacitive sensor antenna 30 are also close to an inner surface of the side wall 17. Except from the position of the flexible part 24, the edge 32 copies the outline of the side wall 17 and of the corner 21 .

[0126] The capacitive sensor antenna 30 of Figures 6 and 7 is substantially U-shaped and follows an upper part of the edge 32 and of the corner 21 close to the first end of the casing 10. The U-shaped capacitive sensor antenna 30 is placed at a first end of the casing 10 and said first end is placed close to the rim 9 of the metered dose inhaler 2. An auxiliary part 30a of the capacitive sensor antenna 30 may also extend along other parts of the edge 32 and of the side wall 17, as shown in Figure 6.

[0127] The capacitive proximity device 29 is configured to detect, through the capacitive sensor antenna 30, 30a, the hand of a user grabbing the electronic module 3 attached to the metered dose inhaler 2, for each grip style shown in Figure 9, and to send a signal to the Microcontroller MCU.

[0128] The additional portion 23 carries a switch 34 facing the front wall 13 of the casing 10. The switch 34 is connected to the power battery 12 and possibly to the Microcontroller MCU. A lever 35 is fashioned in the front wall 13 of the casing 10 and is coupled to the switch 34. The lever 35 is cut out in the front wall 13 and has a proximal end integral with the front wall 13 and a distal end interacting with the switch 34.

[0129] A part of the lever 35 located between the proximal end and the distal end protrudes from the front wall 13 to engage the back side 6a of the housing 6. When the electronic module 3 is mounted on the metered dose inhaler 2, the lever 35 engages the back side 6a of the housing 6 and the back side 6a pushes the switch 34 causing connection of the power battery 12 to the electronic unit 11 and activation of the electronic unit 11 . The switch 34 remains depressed while the electronic module 3 is attached to the metered dose inhaler 2 to provide the electronic unit 11 with a signal indicating the attachment of the electronic module 3 to the metered dose inhaler 2.

[0130] The switch 34 may also be a shelf-life-latch switch configured to connect the power battery 12 to the electronic unit 11 at the first use of the electronic module 3 (i.e. first use after manufacturing and storage) and to hold electronically the connection of the power battery 12 with electronic unit 11 permanently thereafter.

[0131] In use, the electronic module 3 picked up from the shelf is in a shelf-life mode. When the electronic module 3 is clipped on the metered dose inhaler 2, the switch 34 connects the power battery 12 and the electronic unit 11 is put in a deep sleep mode. A very low power of a wake-up signal is required to bring the Microcontroller MCU out of the deep sleep mode.

[0132] According to a first example procedure (Figure 10), in the deep sleep mode, the capacitive proximity device 29 is active. When the user grabs the metered dose inhaler assembly 1 with pinch grip handling gesture (Figure 10 - Touch), a change in capacitance is detected by the capacitive proximity device 29 through the capacitive sensor antenna 30. A wake-up signal from the capacitive proximity device 29 is sent to the Microcontroller MCU and wakes up the Microcontroller MCU from the deep sleep state. Also the accelerometer 28, the pressure sensor 26 and the inductive sensor 25 are powered.

[0133] The accelerometer 28 is configured to send signals to the Microcontroller MCU qualifying readiness for use. For instance, if a stable angle of the metered dose inhaler assembly 1 relative to the ground is detected by the Microcontroller MCU through signals from the accelerometer 28 (Figure 10 - Attitude qualified), the Microcontroller MCU is ready to detect an inhalation event and / or activation event. If both activation and inhalation are detected through the pressure sensor 26 and the inductive sensor 25, the electronic module 3 will then determine the coordination between those two events and store the information for later retrieval, for instance via a Bluetooth wireless connection. If any one of the above events does not occur within a specified timeout interval, the electronic module 3 will re-enter the deep sleep mode without storing any information.

[0134] According to another example procedure, in the deep sleep mode, the accelerometer is active. When the user grabs the metered dose inhaler assembly 1 and the Microcontroller MCU receives from said accelerometer 28 an acceleration signal above a threshold, the Microcontroller MCU wakes up from the deep sleep state and the capacitive proximity device 29 is powered.

[0135] When the user grabs the metered dose inhaler assembly 1 with pinch grip handling gesture, a change in capacitance is detected by the capacitive proximity device 29 through the capacitive sensor antenna 30 and further sensors or functionalities of the electronic module 3 are activated. For instance, the Microcontroller MCU is ready to detect an inhalation event and / or activation event as disclosed above.

[0136] According to another example procedure, in the deep sleep mode, the accelerometer is active. When the user moves the metered dose inhaler assembly 1 and an acceleration signal above a threshold is generated, the acceleration signal above a threshold powers the capacitive proximity device 29. When the user grabs the metered dose inhaler assembly 1 with pinch grip handling gesture, a change in capacitance is detected by the capacitive proximity device 29 through the capacitive sensor antenna 30. A wake-up signal from the capacitive proximity device 29 is sent to the Microcontroller MCU and wakes up the Microcontroller MCU from the deep sleep state.

[0137] Figure 11 shows the result of a test whereby a human user picks up the metered dose inhaler assembly 1 through each of the six grips shown in Figure 9. In Figure 9, only the metered dose inhaler 2 is depicted. Anyway, the same grips apply also to the metered dose inhaler assembly 1 of the present invention. Each grip was cycled through in order twice, so the graphs show twelve events.

[0138] The first top graph of Figure 11 is the raw output of the inductive sensor 25 which detects the canister 5 position during actuation.

[0139] The second graph is a combination of a high pass and low pass filter outputs used to process the inductive sensor 25 data and the decision threshold “T” for detection of an actuation.

[0140] The third graph shows dosage events detected in real-time by the device and in post-processing.

[0141] The fourth bottom graph plots the output of the capacitive proximity device 29 during use.

[0142] As can be appreciated, an event has been detected by the capacitive proximity device 29 corresponding to each of the actuations during the test. List of parts

[0143] 1 metered dose inhaler assembly

[0144] 2 metered dose inhaler

[0145] 3 electronic module

[0146] 4 hollow body

[0147] 5 canister

[0148] 6 housing

[0149] 6a back side

[0150] 6b front side

[0151] 7 mouthpiece

[0152] 8 gap

[0153] 9 rim

[0154] 10 casing

[0155] 11 electronic unit

[0156] 12 power battery

[0157] 13 front wall

[0158] 14 hooks

[0159] 15 elastic projection

[0160] 16 back wall

[0161] 17 side wall

[0162] 18 first end wall

[0163] 19 second end wall

[0164] 20 lateral walls

[0165] 21 corner

[0166] 22 portion

[0167] 23 additional portion

[0168] 24 flexible part

[0169] 25 inductive sensor

[0170] 26 digital pressure sensor

[0171] 27 pressure port

[0172] 28 accelerometer

[0173] 29 capacitive proximity device

[0174] 30 capacitive sensor antenna

[0175] 31 capacitive proximity detector 32 edge

[0176] 33 light shield

[0177] 34 switch

[0178] 35 lever

[0179] X-X main axis

[0180] Y-Y central axis

[0181] Z-Z respective axis

Claims

CLAIMS1. An electronic module for a metered dose inhaler, wherein the electronic module is attached or attachable to the metered dose inhaler; the metered dose inhaler (2) comprising: a hollow body (4) comprising: a housing (6) accommodating or configured to accommodate a canister (5) containing a drug formulation to be dispensed; a mouthpiece (7) in fluid communication with the housing (6); a valve seat located in the hollow body (4), between the housing (6) and the mouthpiece (7) and accommodating or configured to accommodate a valve dispensing nozzle of the canister (5); the housing (6) having an aperture (8) delimited by a rim (9) and a part of the canister (5) protruding or being configured to protrude from said aperture (8); the metered dose inhaler (2) being operated by pushing the part of the canister (5) inside the housing (6); wherein the housing (6) extends along a respective main axis (X-X) and the mouthpiece (7) protrudes laterally on a front side (6b) of the housing (6) opposite a back side (6a) of said housing (6) with respect to the main axis (X- X); the canister (5) being movable in the housing (6) parallel to said back side (6a); the electronic module (3) comprising: a casing (10) having: a front wall (13) facing the back side (6a) of the housing (6) of the metered dose inhaler (2) when the electronic module (3) is attached to said metered dose inhaler (2), a back wall (16) opposite the front wall (13), and a side wall (17) extending between the front wall (13) and the back wall (16); an electronic unit (11 ) installed inside the casing (10); the electronic unit (11 ) comprising a capacitive proximity device (29) having a capacitive sensor antenna (30), the capacitive sensor antenna (30) being placed against or close to an inner surface of the back wall (16) and / or the side wall (17) of the casing (10) such that the electronic module (3) and the capacitive sensorantenna (30) are placed on the back side (6a) of the metered dose inhaler (2) when the electronic module (3) is attached to the metered dose inhaler (2).

2. The electronic module according to claim 1 , wherein the capacitive sensor antenna (30) is placed at a first end of the casing (10), said first end being configured to be placed close to the rim (9) delimiting the aperture (8) of the housing (6) of the metered dose inhaler (2).

3. The electronic module according to claim 1 or 2, wherein the back wall (16) and the side wall (17) delimit a corner (21 ) of the casing (10) and the capacitive sensor antenna (30) extends at least in part along said corner (21 ) or parallel to said corner (21 ).

4. The electronic module according to claim 3 when depending on claim 2, wherein the side wall (17) comprises a first end wall (18) at the first end of the casing (10), a second end wall (19) opposite the first end wall (18) and two lateral walls (20) joining the first end wall (18) to the second end wall (19); wherein the capacitive sensor antenna (30) is placed along a portion of the corner (21 ) between the first end wall (18) and the back wall (16).

5. The electronic module according to claim 4, wherein the capacitive sensor antenna (30) extends along portions of the corner (21 ) between the lateral walls (20) and the back wall (16).

6. The electronic module according to any of claims 1 to 5, wherein the capacitive sensor antenna (30) is elongated.

7. The electronic module according to any of claims 1 to 6, wherein the electronic unit (11 ) comprises a printed circuit board and the capacitive sensor antenna (30) is fashioned on said printed circuit board.

8. The electronic module according to claim 7, wherein the capacitive sensor antenna (30) is implemented as a trace in the printed circuit board.

9. The electronic module according to claim 7 or 8, wherein the capacitive sensor antenna (30) is placed at least in part along an edge (32) of the printed circuit board.

10. The electronic module according to claim 7 or 8 or 9 when claim 7 depends on claim 3, 4 or 5, wherein the printed circuit board comprises a portion (22) having said edge (32) and said edge (32) is placed along the corner (21 ) delimited by the back wall (16) and the side wall (17) or parallel to said corner (21 ); said portion (22) being attached to the back wall (16) or placed side by side with the back wall (16) or parallel to the back wall (16).

11. The electronic module according to any of claims 1 to 10, wherein the electronic unit (11 ) comprises a controller unit operatively connected to the capacitive proximity device (29); the capacitive proximity device (29) being configured to detect, through the capacitive sensor antenna (30), the hand of a user grabbing the electronic module (3) and to send a signal to the controller unit.

12. The electronic module according to claim 11 , wherein said signal is configured to wake up the controller unit from a sleep state and / or to activate at least one further sensor or at least one functionality of the electronic module (3).

13. The electronic module according to claim 12, wherein the electronic unit (11 ) comprises an accelerometer (28) and is configured to execute the following procedure: waking up the controller unit from the sleep state and / or activating the at least one further sensor or functionality of the electronic module (3) when receiving the signal from the capacitive proximity device (29); receiving an acceleration signal from the accelerometer (28) qualifying readiness for use.

14. The electronic module according to any of claims 1 to 13, wherein the front wall (13) of the casing (10) is shaped to match the back side (6a) of the housing (6).

15. A metered dose inhaler assembly comprising:- the metered dose inhaler (2), optionally a pressurized metered dose inhaler, as disclosed in claim 1 ; and- the electronic module (3) according to one of the preceding claims 1 to 14.

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