Electronic module for metered-dose inhaler, and metered-dose inhaler assembly equipped with the electronic module

Abstract

The electronic module for a metered-dose inhaler comprises a housing (10) having a front wall (13) configured to face the rear surface (6a) of the housing (6) of the metered-dose inhaler (2), a rear wall (16) opposite to the front wall (13), and a side wall (17) extending between the front wall (13) and the rear wall (16). The electronic unit (11) is incorporated inside the housing (10) and comprises a capacitive proximity device (29) equipped with a capacitive sensor antenna (30). The capacitive sensor antenna (30) is positioned in contact with or close to the inner surface of the rear wall (16) and / or side wall (17) of the housing (10).

Description

Technical Field

[0001] The present invention relates to an electronic module for a metered dose inhaler (MDI), and an assembly comprising a metered dose inhaler and the electronic module. A metered dose inhaler is a device that dispenses a pharmaceutical formulation by inhalation. The metered dose inhaler may be a pressurized metered dose inhaler (pMDI). The electronic module is provided with a capacitance proximity device capable of detecting several types of gripping methods of a user.

Background Art

[0002] Administration of a pharmaceutical formulation by inhalation from an MDI or pMDI is generally known. MDI or pMDI inhalers equipped with sensors and electronic devices for checking the accuracy and regularity of drug intake by a user are also known. The inhaler may comprise one or more sensors and electronic devices, or may be coupled to an electronic module comprising sensors and electronic devices configured to monitor use.

[0003] Electronic devices attached to an inhaler and capable of sensing human contact are also known in the art.

[0004] The document, U.S. Patent Application Publication 2016 / 0144141 A1, discloses a removable cap for measuring the usage of an inhaler. The cap comprises a hollow receiving portion configured to removably receive an inhaler. An extension is provided for housing electronic components comprising an electronic circuit with a controller coupled to a memory device and a power supply. A capacitive touch film is fitted into a finger groove on the top of the cap and is monitored by a dedicated capacitive touch sensor chipset or microcontroller. The capacitive touch sensor is always on and awaits human contact from the outside. When the controller chipset detects human contact, it turns on the circuit board, and the microcontroller software then distinguishes whether the contact is accidental or intentional use of the inhaler.

[0005] The literature, U.S. Patent Application Publication 2016 / 0256639 A1, discloses a usage monitoring device embodied as an accessory device configured to selectively couple to one of a variety of different inhalers. While operating in low-power mode, a first sensor monitors a signal indicating user handling of the drug dispenser. In response to detection of such handling, the device exits low-power mode and begins monitoring a second sensor for a signal indicating drug dispensing. The entire body of the accessory device for a dry powder inhaler may act as a capacitive sensor.

[0006] The document, U.S. Patent Application Publication 2019 / 0224426 A1, discloses a device and method for detecting or sensing one or more parameters of a drug device, such as a shake parameter, an operating parameter, or an inhalation airflow parameter. The sensor device or sensor package is configured to be attached to the drug device. The sensor device comprises a housing that contains one or more sensors, including electrodes and touch sensors such as capacitive or resistive touch sensors.

[0007] The document, U.S. Patent Application Publication 2020 / 0155775 A1, discloses a fluid dispenser device comprising a body equipped with a mouthpiece, a fluid reservoir for housing fluid and propellant gas, and a throttle valve with a valve member. The reservoir is attached to the body and slides between a stop position in which the throttle valve is closed and a dispensing position in which it is open for dispensing a certain volume of fluid. The device comprises a capacitive sensor provided on the distal end surface of the body, which receives an electronic module, for detecting the pressure of the user's finger.

[0008] The document, U.S. Patent Application Publication 2019 / 0125990 A1, discloses a disposable usage record smart label for an inhaler. The usage record smart label comprises a capacitive contact sensing plate that detects the presence of an active body organ, such as a hand or finger. The usage record smart label is affixed to the bottom and side walls of the MDI. [Prior art documents] [Patent Documents]

[0009] [Patent Document 1] U.S. Patent Application Publication No. 2016 / 0144141 A1 [Patent Document 2] U.S. Patent Application Publication No. 2016 / 0256639 A1 [Patent Document 3] U.S. Patent Application Publication No. 2019 / 0224426 A1 [Patent Document 4] U.S. Patent Application Publication No. 2020 / 0155775 A1 [Patent Document 5] U.S. Patent Application Publication No. 2019 / 0125990 A1 [Overview of the project]

[0010] The applicant recognized that, with prior art devices, it is not possible to correctly and easily distinguish between the way a user grasps a metered-dose inhaler (MDI) for the purpose of picking it up and moving it, for example, by placing the MDI in a bag or pocket, or moving it from one place to another, and one of the specific ways of grasping it for dose delivery and drug inhalation, as also defined by the implementation guidelines.

[0011] The applicant acknowledges that all capacitive sensors or switches for MDIs disclosed in the documents, U.S. Patent Publication No. 2016 / 0144141 A1, U.S. Patent Publication No. 2019 / 0224426 A1, and U.S. Patent Publication No. 2020 / 0155775 A1, are located on top of the canister to sense pressure applied by the user's fingertips. In any case, when handling the device and moving it from one place to another, unintended pressure may be applied to the top portion, and this pressure does not indicate the user's intention to take a drug dose. In fact, the microcontroller in U.S. Patent Publication No. 2016 / 0144141 A1 must use a flow sensor and an accelerometer, as well as an algorithm to distinguish between accidental contact and actual use of the inhaler.

[0012] The applicant also recognized that the capacitive sensor referred to in the document, U.S. Patent Application Publication 2016 / 0256639 A1, refers to a dry powder metered-dose inhaler (not an MDI), and that if the entire body of the accessory device operates as a capacitive sensor, as disclosed in the description of U.S. Patent Application Publication 2016 / 0256639 A1, it would be extremely difficult to distinguish between accidental contact and actual inhaler use.

[0013] The objective of the present invention is to eliminate the aforementioned drawbacks of conventional electronic modules for metered-dose inhalers.

[0014] The object of the present invention is to provide an electronic module for a metered-dose inhaler that can distinguish between accidental contact or general handling and actual use for drug inhalation.

[0015] In particular, an object of the present invention is to provide an electronic module for a metered-dose inhaler that can understand when the user is gripping the metered-dose inhaler in order to activate it, especially with respect to any gripping style adopted by the user.

[0016] Another objective of the present invention is to provide an electronic module for a metered-dose inhaler that understands when the metered-dose inhaler is to operate safely and reliably.

[0017] Another objective of the present invention is to provide an electronic module for a metered-dose inhaler that can be activated only when the user intends to use the inhaler.

[0018] The object of the present invention is to provide an electronic module for a metered-dose inhaler that activates quickly enough so that inhalation events detected through specific sensors are not missed.

[0019] At least one of the above objectives is substantially achieved by an electronic module for a metered-dose inhaler and a metered-dose inhaler assembly according to the appended claims and / or one or more of the following embodiments.

[0020] According to a first independent embodiment, the electronic module for a metered-dose inhaler is: A front wall configured to face the rear surface of the housing of a metered-dose inhaler when an electronic module is attached to the metered-dose inhaler, the housing housing or configured to house a canister protruding from the housing, the canister being movable within the housing parallel to the rear surface, The front wall and the rear wall on the opposite side, and, Side walls extending between the front wall and the rear wall, Equipped with, housing, Electronic units incorporated inside the enclosure, comprises an electronic unit that includes a capacitive proximity device with a capacitive sensor antenna, the capacitive sensor antenna being disposed in contact with or in proximity to the inner surface of the rear wall and / or side wall of the housing.

[0021] According to a second independent aspect, a metered-dose inhaler assembly includes a housing that houses or is configured to house a canister containing a pharmaceutical formulation to be dispensed, a mouthpiece in fluid communication with the housing, a hollow body located between the housing and the mouthpiece, the hollow body including a valve seat that houses or is configured to house a valve dispensing nozzle of the canister, the housing including an opening defined by a periphery and a portion of the canister that protrudes or is configured to protrude from the opening, and the metered-dose inhaler being operated by pushing a portion of the canister inside the housing. An electronic module according to one or more of the foregoing aspects or the following aspects is provided.

[0022] The applicant has verified that the electronic module according to the present invention can detect the way a user holds the metered-dose inhaler indicating an intention to use it. In fact, the position of the capacitive sensor antenna is adapted to detect substantially all styles of gripping commonly used when holding the metered-dose inhaler with the intention of inhaling.

[0023] The applicant has verified that the electronic module according to the present invention can perform the above detection safely and reliably.

[0024] The applicant has verified that the capacitive proximity device equipped to perform the above detection is relatively low-cost and sufficiently sensitive.

[0025] In one aspect, the electronic module is removably attached or configured to be attached to a metered-dose inhaler.

[0026] In one embodiment, the metered-dose spray inhaler may be a pressurized spray metered-dose inhaler.

[0027] In one embodiment, a capacitive sensor antenna is positioned at a first end of the housing, the first end being positioned close to the periphery defining the opening of the housing of the metered-dose spray inhaler, and the canister protrudes from the opening.

[0028] In one embodiment, the housing extends along its respective main axis, the mouthpiece protrudes laterally from the front of the housing on the side opposite to the rear of the housing with respect to the main axis, and the electronic module and capacitive sensor antenna are located on the rear.

[0029] In one embodiment, the rear wall and side wall define the corners of the housing, and the capacitive sensor antenna extends at least partially along or parallel to the corners.

[0030] In one embodiment, the side wall comprises a first end wall at the first end of the housing, a second end wall opposite the first end wall, and two lateral walls joining the first end wall to the second end wall.

[0031] In one embodiment, the capacitive sensor antenna is positioned along a portion of the corner between the first end wall and the rear wall.

[0032] In one embodiment, the capacitive sensor antenna extends along the portion of the corner between the side wall and the rear wall.

[0033] In one embodiment, the capacitive sensor antenna is elongated.

[0034] In one embodiment, the electronic unit includes a printed circuit board, and the capacitive sensor antenna is formed on the printed circuit board.

[0035] In one embodiment, the capacitive sensor antenna is mounted as a trace on a printed circuit board.

[0036] In one embodiment, the trace is positioned to extend close to the inside of the electronic module's housing. This makes one area of ​​the electronic module's housing highly sensitive to user contact.

[0037] In one embodiment, the capacitive sensor antenna is positioned at least partially along the edge of the printed circuit board.

[0038] In one embodiment, the printed circuit board comprises a portion having the edge, the edge being arranged along or parallel to a corner defined by the rear wall and the side wall.

[0039] In one embodiment, the portion is attached to the rear wall, or is arranged alongside or parallel to the rear wall.

[0040] In one embodiment, the electronic unit includes a controller unit operably connected to a capacitive proximity device.

[0041] In one embodiment, the capacitive proximity device is configured to detect the user's hand holding the electronic module through a capacitive sensor antenna and transmit a signal to the controller unit.

[0042] In one embodiment, the signal is configured to wake the controller unit from a sleep state and / or activate at least one other sensor or at least one function of the electronic module.

[0043] The applicant has verified that the electronic module of the present invention can reliably activate the module's electronic units in all commonly used gripping styles when touched by a user.

[0044] The applicant has verified that the electronic module of the present invention enables power saving of the power supply battery. In fact, other detection sensors and devices of the electronic module consume a relatively large amount of power if left constantly enabled. Therefore, such other detection sensors and devices are kept disabled and enabled by a capacitive proximity device with very low power consumption. When a user's hand approaches or touches this area of ​​the housing, the capacitive proximity device asserts a contact output and issues an activation event to the electronic controller. This enables the inhalation and activation detection sensors and devices, allowing them to wait for inhalation and activation events. If no such event occurs within the timeout period, the electronic module may return to a low-power sleep mode.

[0045] In one embodiment, the electronic unit includes at least one other sensor, such as a pressure sensor or flow meter that senses the airflow in the air path and intake of the assembly, or an induction sensor that detects the position of the canister.

[0046] In one embodiment, the electronic unit includes an accelerometer. In one embodiment, the electronic unit is Upon receiving a signal from a capacitive proximity device, the controller unit is woken from sleep mode and / or activated at least one other sensor or function of the electronic module. Receiving an acceleration signal from the accelerometer indicating that it is ready for use. It is configured to perform a procedure consisting of the following steps.

[0047] In one embodiment, the acceleration signal from the accelerometer indicates the orientation of the electronic module and the metered-dose spray inhaler relative to the ground.

[0048] In one embodiment, the acceleration signal from the accelerometer indicates the stable angle of the electronic module and the metered-dose spray inhaler relative to the ground.

[0049] A capacitive proximity device responds to user contact when the electronic module is touched before or during the operation of the metered-dose inhaler device. The capacitive proximity device is used to wake the system from a low-power deep sleep mode. An accelerometer is used to monitor the orientation of the electronic module, and consequently, the orientation of the metered-dose inhaler itself. The accelerometer may also be used to ensure the orientation of the metered-dose inhaler is qualified to monitor the activation event and compliance during inhalation events. In another embodiment, the electronic unit is When an acceleration signal exceeding a threshold is received from the accelerometer, power is supplied to the capacitive proximity device, and subsequently Upon receiving a signal from a capacitive proximity device, the controller unit is woken from sleep mode and / or activated by at least one other sensor or function of the electronic module. It is configured to perform a procedure consisting of the following steps.

[0050] In one embodiment, the casing is made of plastic.

[0051] In one embodiment, the rear wall is flat or substantially flat.

[0052] In one embodiment, the capacitive sensor antenna is U-shaped.

[0053] In one embodiment, the rear wall has a rectangular outline with rounded edges.

[0054] In one embodiment, the portion of the printed circuit board has substantially the same contour as the rear wall.

[0055] In one embodiment, the printed circuit board is arranged inside the housing and includes an additional portion parallel to the aforementioned portion.

[0056] In one embodiment, the aforementioned portion and additional portion are rigid and optionally made of glass fiber resin.

[0057] In one embodiment, the aforementioned portion and the additional portion are joined together by a flexible portion of the printed circuit board.

[0058] In one embodiment, the printed circuit board supports a power battery.

[0059] In one embodiment, the power battery is mounted in the aforementioned part.

[0060] In one embodiment, the power battery is located between the aforementioned part and the additional part.

[0061] This makes it possible to improve space utilization and keep electronic devices small.

[0062] In one embodiment, the front wall of the enclosure is complementary to the rear surface of the housing. That is, the front wall of the enclosure has a shape that matches the rear surface of the housing.

[0063] In one embodiment, the front wall of the housing is concave, and the rear surface of the housing is convex.

[0064] In one embodiment, the housing includes at least one hook that engages with or is configured to engage with the periphery of the housing.

[0065] In one embodiment, at least one hook is positioned at or near the first end of the housing.

[0066] In one embodiment, the housing comprises projections spaced apart from at least one hook, optionally elastic projections, the projections configured to clip onto the housing in a zone spaced apart from the periphery of the housing.

[0067] In one embodiment, the elastic projection is located at the second end of the housing, opposite to the first end.

[0068] In one embodiment, the housing is elongated along each of its axes.

[0069] In one embodiment, when the electronic module is attached to a metered-dose inhaler, each of the axes is parallel to the principal axis of the housing.

[0070] In one embodiment, the second end of the housing includes an elbow portion formed on the side opposite to the mouthpiece.

[0071] In one embodiment, the protrusion of the housing is clipped to the elbow portion, or is configured to be clipped to it.

[0072] In one embodiment, a lever is coupled to a switch formed on the front wall and connected to a power battery, and when the electronic module is mounted in a metered-dose inhaler, the lever engages with the rear surface of the housing to connect the power battery to the electronic unit.

[0073] In one embodiment, the lever and switch are configured to connect the power battery to the electronic unit when the electronic module is used for the first time, that is, when it is used for the first time after storage.

[0074] In one embodiment, the switch remains pressed while the electronic module is attached to the metered-dose inhaler.

[0075] In one embodiment, the switch is configured to supply a signal to the electronic unit indicating that the electronic module is attached to a metered-dose inhaler.

[0076] In one embodiment, the switch is configured to electronically and permanently maintain a connection with the electronic unit of the power battery after its initial use.

[0077] The applicant verified that because the power battery is completely disconnected from the electronic unit during storage, the storage life, i.e., the time the electronic module spends in storage before its first use, is increased.

[0078] In one embodiment, the lever is provided by a notch in the front wall.

[0079] In one embodiment, the lever comprises a proximal end integrated with the front wall and a distal end that interacts with a switch.

[0080] In one embodiment, a portion of the lever located between its proximal and distal ends protrudes from the front wall and engages with the rear surface of the housing when the electronic module is attached to a metered-dose inhaler.

[0081] In one embodiment, the switch is located on the printed circuit board, and optionally, on an additional portion of the printed circuit board facing the front wall of the housing.

[0082] In one embodiment, the mouthpiece has its own central axis.

[0083] In one embodiment, the main axis and the central axis intersect each other diagonally such that the hollow body is L-shaped or substantially L-shaped.

[0084] In one embodiment, the principal axis and the central axis are defined at an angle of 90° to 120°.

[0085] In one embodiment, the hollow body is made of plastic.

[0086] In one embodiment, the canister is made of metal.

[0087] Further features and advantages will become clearer from the detailed description of preferred but non-exclusive embodiments of the electronic module for metered-dose inhalers and metered-dose inhaler assemblies according to the present invention. [Brief explanation of the drawing]

[0088] [Figure 1] This is a 3D drawing of a metered-dose inhaler assembly comprising a metered-dose inhaler and an electronic module according to the present invention. [Figure 2] This is a 3D drawing of a metered-dose inhaler assembly comprising a metered-dose inhaler and an electronic module according to the present invention. [Figure 3] This is a 3D model of an electronic module. [Figure 4] This is a 3D model of an electronic module. [Figure 5] Figures 3 and 4 are exploded views of the electronic module. [Figure 6] Figures 1 to 5 show the printed circuit boards of the electronic modules. [Figure 7] This is a further 3D view of the electronic module, featuring a transparent section that reveals its internal components. [Figure 8] This is a schematic diagram of the electronic components of an electronic module. [Figure 9] This diagram shows various ways to hold a metered-dose inhaler. [Figure 10] This is a block diagram of the procedure performed by the electronic module. [Figure 11] This is a graph of the results of a test conducted using the electronic module of the present invention. [Modes for carrying out the invention]

[0089] Referring to the attached 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 removed from the metered-dose inhaler 2 without the use of tools.

[0090] Metered dose inhaler The metered-dose inhaler 2 may be known in itself and commercially available on the market. The metered-dose inhaler 2 shown as an example in Figures 1 and 2 comprises a hollow body 4, i.e., an actuator, and a canister 5 for storing the drug formulation to be dispensed. The canister 5 is housed in the hollow body 4.

[0091] The hollow body 4 comprises a housing 6 that houses or is configured to house a canister 5, and a mouthpiece 7 that is in fluid communication with the housing 6. A valve seat, not shown in the accompanying drawings, is located within the hollow body 4, between the housing 6 and the mouthpiece 7. The housing 6, mouthpiece 7, and valve seat may be a single piece made of molded plastic.

[0092] The housing 6 is a type of tubular element extending along the main axis "XX". The mouthpiece 7 is a type of tubular element extending along the central axis "YY". The main axis "XX" and the central axis "YY" intersect each other at an angle such that the hollow housing 6 is L-shaped or substantially L-shaped. In the embodiment shown in the attached diagram, the main axis "XX" and the central axis "YY" define an angle of approximately 100° to 110°.

[0093] The first end of the housing 6 has an opening defined by a periphery 9. The second end of the housing 6, on the opposite side, is connected to the mouthpiece 7, and an elbow portion is formed on the opposite side of the mouthpiece 7.

[0094] Canister 5 may be made of metal, for example, aluminum or stainless steel, and may be known in itself, and comprises a valve dispensing nozzle or throttle valve not shown. The chemical formulation in the canister contains a liquefied gas propellant (pressurized spray MDI) and, often, a stabilizing excipient.

[0095] As shown in Figures 1 and 2, when the canister 5 is housed in the housing 6 of the hollow body 4, the valve dispensing nozzle of the canister 5 is positioned on the valve seat of the hollow body 4, and a portion of the canister 5 opposite the valve dispensing nozzle protrudes from the opening. A gap 8 is defined between the canister 5 and the edge 9, surrounding the canister 5.

[0096] The metered-dose inhaler 2 is operated by pushing the canister 5 toward the housing 6, that is, by pressing a portion of the canister 5 that protrudes from the gap 8, in order to take medication. The canister 5 moves parallel to the main axis line "XX" and the front 6b and rear 6a of the housing 6.

[0097] The valve dispensing nozzle is thus pressed against the valve seat, spraying out the drug formulation. When the user inhales through the mouthpiece 7 at the same time as or immediately after pressing, air enters the hollow body 4 through the gap 8 and flows into the mouthpiece 7, where the air and drug are mixed and inhaled by the user through the opening of the mouthpiece 7.

[0098] Electronic module The electronic module 3 is configured to be detachably attached to the metered-dose inhaler 2, so that when the medication in the old metered-dose inhaler runs out, the same electronic module 3 may be used in another new metered-dose inhaler.

[0099] The electronic module 3 comprises an electronic unit 11 and a housing 10, such as a plastic housing, that surrounds a power battery 12, such as a lithium battery, which is connected to the electronic unit 11 and supplies power to the electronic unit 11.

[0100] The electronic module 3 is operably connected to the electronic unit 11 and further includes sensors configured to detect, for example, user operation, activation of the metered-dose inhaler, proper inhalation, and / or attachment of the electronic module 3 to the metered-dose inhaler 2. The sensors may operate on the exterior of the housing 10 or be located inside the housing 10. The electronic module 3 may also include signal notification devices, not shown, such as LEDs or speakers, operably connected to the electronic unit 11 and configured to notify the user of the status and / or operation of the electronic module 3 and / or the metered-dose inhaler 2 (for example, through visual or audio signals).

[0101] As shown in Figures 3 and 4, the housing 10 has a front wall 13 that is complementary to the rear surface 6a of the housing 6 of the hollow body 4 of the metered-dose inhaler 2, on the side opposite to the front surface 6b from which the mouthpiece 7 protrudes. The front wall 13 is concave and conforms to the convex, rounded side surface of the rear surface 6a of the housing 6.

[0102] The housing 10 is elongated along each axis "ZZ" which is parallel to the main axis "XX" of the housing 6 when the electronic module 3 is attached to the metered-dose inhaler 2. The first end of the housing 10 protrudes from the front wall 13 and comprises a hook assembly with two hooks 14. The second end of the housing 10 is located opposite the first end along each axis "ZZ" and comprises an elastic projection 15.

[0103] Two hooks 14 are configured to engage with the periphery 9 of the housing 6, and an elastic projection 15 is configured to clip onto the housing 6 at the elbow. When the electronic module 3 is clipped onto the metered-dose inhaler 2, the electronic module 3 is positioned on the rear surface 6a.

[0104] The front wall 13, the two hooks 14, and the elastic projection 15 are part of the first molded part shown in Figure 5.

[0105] The housing 10 comprises a second molded part in the shape of a shell, a front wall 13 and a rear wall 16 opposite to it (Figures 1 and 7), and a side wall 17 extending between the front wall 13 and the rear wall 16.

[0106] The rear wall 16 has a substantially rectangular contour, including a rounded edge, and is flat or substantially flat.

[0107] The side wall 17 comprises a first end wall 18 that defines or delineates the boundary of the first end of the housing 10, a second end wall 19 opposite to the first end wall 18, and two lateral walls 20 that join the first end wall 18 to the second end wall 19.

[0108] In the embodiment shown in the attached figure, the rear wall 16 and the side wall 17 are joined to each other at the corner 21 of the housing 10 that surrounds the rear wall 16 and has a chamfered edge.

[0109] The electronic unit 11, incorporated inside the housing 10, includes a semi-flexible type printed circuit board (PCB: printed circuit board, a laminated sandwich structure of conductive and insulating layers). The printed circuit board includes a rigid type, for example, a portion 22 and an additional portion 23 made of glass fiber resin. The portion 22 and the additional portion 23 are joined to each other by a flexible portion 24, which has conductive paths connecting the conductive paths of the portion 22 and the additional portion 23 and the electronic components.

[0110] Part 22 and the additional part 23 are assembled inside the housing 10 parallel to each other, as shown in Figure 5. The power battery 12 is incorporated into part 22, and when part 22 and the additional part 23 are properly housed in the housing 10, the power battery 12 is positioned between part 22 and the additional part 23.

[0111] Part 22 and additional part 23 support the controller unit and other electronic components of the electronic unit 11. The controller unit may be a microcontroller MCU (Schematically shown in Figure 8) equipped with a CPU, flash memory and RAM memory, peripheral device controllers and a receive / transmit device (such as BLE).

[0112] The additional section 23 may include an induction sensor 25, shaped like an induction coil, which is operably connected to a microcontroller MCU through an analog-to-digital converter. The induction sensor 25 may supply the microcontroller MCU with signals correlated with the position and movement of the canister 5.

[0113] Part 22 may carry a digital pressure sensor 26 operably connected to a microcontroller MCU. The digital pressure sensor 26 is fluidly connected to a pressure port 27 that opens between two hooks 14 on the front wall 13 when the electronic module 3 is assembled. The pressure sensor 26 may also detect the flow of air through the gap 8 and may act as a flow meter that senses suction.

[0114] Part 22 or additional part 23 further comprises an accelerometer 28 ( schematically shown in Figure 8) operably connected to a microcontroller MCU. The accelerometer 28 is configured to supply signals to the microcontroller MCU that correlate with the position, orientation, and / or motion of the electronic module 3. LEDs and switches may also be mounted on or connected to part 22.

[0115] The electronic unit 11 further comprises a capacitive proximity device 29, which includes a capacitive sensor antenna 30 and a capacitive proximity detector 31 (Figure 8). The capacitive proximity detector 31 is operably connected to a microcontroller MCU.

[0116] The capacitive sensor antenna 30 is mounted as a trace on the printed circuit board. In the exemplary embodiment shown in the attached figure, the capacitive sensor antenna 30 is an elongated trace extending along the edge 32 of portion 22.

[0117] The portion 22 has substantially the same contour as the rear wall 16. That is, the shape of the edge 32 is similar to the shape of the corner 21. When the printed circuit board is assembled into the housing 10, the portion 22 is close to the rear wall 16 and positioned alongside it. If the LEDs are located on the back of the portion 22 facing the rear wall 16, a light shielding plate 33 may be placed between the portion 22 and the rear wall 16 (as shown in Figure 5).

[0118] When the printed circuit board is assembled into the housing 10, the edge portion 32 extends parallel to the corner portion 21, and substantially along its entire length. The edge portion 32 and the capacitive sensor antenna 30 are also close to the inner surface of the side wall 17. The edge portion 32 mimics the contours of the side wall 17 and the corner portion 21, except for the location of the flexible portion 24.

[0119] The capacitive sensor antenna 30 in Figures 6 and 7 is substantially U-shaped and extends along the edge 32 and the upper part of the corner 21 adjacent to the first end of the housing 10. The U-shaped capacitive sensor antenna 30 is positioned at the first end of the housing 10, which is positioned adjacent to the periphery 9 of the metered-dose spray inhaler 2. As shown in Figure 6, an auxiliary portion 30a of the capacitive sensor antenna 30 may further extend along the edge 32 and other parts of the side wall 17.

[0120] The capacitive proximity device 29 is configured to detect the user's hand gripping the electronic module 3 attached to the metered-dose spray inhaler 2 for each gripping style shown in Figure 9, via the capacitive sensor antennas 30, 30a, and to transmit a signal to the microcontroller MCU.

[0121] The additional section 23 supports a switch 34 facing the front wall 13 of the housing 10. The switch 34 is connected to a power battery 12 and, in some cases, to a microcontroller MCU. A lever 35 is formed on the front wall 13 of the housing 10 and is coupled to the switch 34. The lever 35 has a notch in the front wall 13 and has a proximal end that is integrated with the front wall 13 and a distal end that interacts with the switch 34.

[0122] A portion of the lever 35 located between its proximal and distal ends protrudes from the front wall 13 and engages with the rear surface 6a of the housing 6. When the electronic module 3 is installed in the metered-dose inhaler 2, the lever 35 engages with the rear surface 6a of the housing 6, and the rear surface 6a presses the switch 34, connecting the power battery 12 to the electronic unit 11 and activating the electronic unit 11.

[0123] While the electronic module 3 is attached to the metered-dose inhaler 2, the switch 34 remains pressed, supplying a signal to the electronic unit 11 indicating that the electronic module 3 is attached to the metered-dose inhaler 2.

[0124] Switch 34 may also be a shelf-life latch switch configured to connect the power battery 12 to the electronic unit 11 upon the first use of the electronic module 3 (i.e., the first use after manufacturing and storage), and thereafter to electronically and permanently maintain the connection of the power battery 12 to the electronic unit 11.

[0125] During use, the electronic module 3, when removed from the shelf, is in storage life mode. When the electronic module 3 is clipped to the metered-dose inhaler 2, the switch 34 is connected to the power battery 12, and the electronic unit 11 enters deep sleep mode. A very low-power wake signal is required to wake the microcontroller MCU from deep sleep mode.

[0126] According to the first exemplary procedure (Figure 10), the capacitive proximity device 29 is active in deep sleep mode. When the user grasps the metered-dose inhaler assembly 1 with a pinch-grip motion (Figure 10, contact), the capacitive proximity device 29 detects a change in capacitance through the capacitive sensor antenna 30. An activation signal from the capacitive proximity device 29 is transmitted to the microcontroller MCU, waking the microcontroller MCU from deep sleep. Power is also supplied to the accelerometer 28, pressure sensor 26, and induction sensor 25.

[0127] The accelerometer 28 is configured to transmit a signal to the microcontroller MCU indicating that it is ready for use. For example, when the microcontroller MCU detects through the signal from the accelerometer 28 that the angle of the metered-dose spray inhaler assembly 1 is stable relative to the ground (Figure 10, the orientation is deemed qualified), the microcontroller MCU is ready to detect inhalation events and / or activation events.

[0128] When both operation and suction are detected via the pressure sensor 26 and induction sensor 25, the electronic module 3 determines how to coordinate between the two events, stores the information, and retrieves it later, for example, via a Bluetooth® wireless connection. If neither of the above events occurs within a specified timeout interval, the electronic module 3 returns to deep sleep mode without storing any information.

[0129] According to another exemplary procedure, in deep sleep mode, the accelerometer is active. When the user grasps the metered-dose inhaler assembly 1 and the microcontroller MCU receives an acceleration signal from the accelerometer 28 that exceeds a threshold, the microcontroller MCU wakes up from deep sleep and the capacitive proximity device 29 is powered.

[0130] When the user grasps the metered-dose inhaler assembly 1 in a pinch-grip manner, the capacitive proximity device 29 detects a change in capacitance through the capacitive sensor antenna 30, and other sensors or functions of the electronic module 3 are activated. The microcontroller MCU is ready to detect inhalation events and / or activation events, for example, as disclosed above.

[0131] According to another exemplary procedure, the accelerometer is active in deep sleep mode. When the user moves the metered-dose inhaler assembly 1 and an acceleration signal exceeding a threshold is generated, the acceleration signal exceeding the threshold powers the capacitive proximity device 29. When the user grasps the metered-dose inhaler assembly 1 in a pinch-grip manner, the capacitive proximity device 29 detects a change in capacitance through the capacitive sensor antenna 30. An activation signal from the capacitive proximity device 29 is sent to the microcontroller MCU, waking the microcontroller MCU from deep sleep.

[0132] Figure 11 shows the results of a test in which a human user picked up the metered-dose inhaler assembly 1 using each of the six gripping methods shown in Figure 9. Figure 9 only depicts the metered-dose inhaler 2. In any case, the same gripping methods apply to the metered-dose inhaler assembly 1 of the present invention. Since each gripping method was repeated twice in sequence, the graph shows 12 events.

[0133] The first upper graph in Figure 11 shows the raw output of the induction sensor 25, which detects the position of the operating canister 5.

[0134] The second graph shows the combinations of the high-pass filter output and low-pass filter output used to process the data from the induction sensor 25, along with the decision threshold "T" for detecting operation.

[0135] The third graph shows dose events detected by the device in real time and in post-processing.

[0136] The fourth graph at the bottom plots the output of the capacitive proximity device 29 in use.

[0137] To make it easier to understand, each event corresponding to the operation during the test is detected by the capacitive proximity device 29. [Explanation of Symbols]

[0138] 1 Metered dose inhaler assembly 2 Metered dose inhaler 3. Electronic Modules 4 Hollow body 5 Canister 6 Housing 6a Rear 6b Front 7 Mouthpiece 8 gaps 9 Periphery 10 cabinets 11 Electronic Units 12 power battery 13 Front wall 14 hooks 15 Elastic protrusion 16 Back wall 17 Side wall 18. First End Wall 19. Second End Wall 20 Side wall 21 Corner 22 parts 23 Additional parts 24 Flexible part 25 Induction Sensor 26 Digital pressure sensors 27 pressure ports 28 Accelerometer 29 Capacitive proximity devices 30 Capacitive Sensor Antenna 31 Capacitive proximity detector 32 Edge 33 Light shielding plate 34 switches 35 Lever XX Main axis YY center axis ZZ Each axis

Claims

1. An electronic module for a metered-dose inhaler, The electronic module is attached to or can be attached to the metered-dose spray inhaler. The aforementioned metered-dose spray inhaler (2) comprises a hollow body (4), The hollow body (4) A housing (6) which contains or is configured to contain a canister (5) for storing a pharmaceutical preparation to be dispensed, A mouthpiece (7) that is in fluid communication with the housing (6), and A valve seat located between the housing (6) and the mouthpiece (7) of the hollow body (4), which houses or is configured to house the valve dispensing nozzle of the canister (5), It is equipped with, The housing (6) comprises an opening (8) defined by a periphery (9) and a part of the canister (5) that protrudes from or is configured to protrude from the opening (8), and the metered-dose spray inhaler (2) is operated by pressing the part of the canister (5) inside the housing (6). The housing (6) extends along each main axis (X-X), the mouthpiece (7) protrudes laterally from the front surface (6b) of the housing (6) on the side opposite to the rear surface (6a) of the housing (6) with respect to the main axis (X-X), and the canister (5) is movable within the housing (6) parallel to the rear surface (6a). The aforementioned electronic module (3) is The enclosure (10) and The electronic unit (11) is incorporated inside the housing (10), It is equipped with, The housing (10) is When the electronic module (3) is attached to the metered-dose inhaler (2), the front wall (13) of the housing (6) of the metered-dose inhaler (2) facing the rear surface (6a), The rear wall (16) opposite to the front wall (13), and A side wall (17) extending between the front wall (13) and the rear wall (16), It is equipped with, The electronic unit (11) comprises a capacitive proximity device (29) equipped with a capacitive sensor antenna (30), The capacitive sensor antenna (30) is positioned in contact with or close to the inner surface of the rear wall (16) and / or the side wall (17) of the housing (10), and when the electronic module (3) is attached to the metered-dose spray inhaler (2), the electronic module (3) and the capacitive sensor antenna (30) are positioned on the rear surface (6a) of the metered-dose spray inhaler (2). Electronic module.

2. The electronic module according to claim 1, wherein the capacitive sensor antenna (30) is located at a first end of the housing (10), and the first end is located close to the periphery (9) that defines the opening (8) of the housing (6) of the metered-dose spray inhaler (2).

3. The electronic module according to claim 1 or 2, wherein the rear wall (16) and the side wall (17) define a corner (21) of the housing (10), and the capacitive sensor antenna (30) extends at least partially along or parallel to the corner (21).

4. The aforementioned side wall (17) The first end wall (18) at the first end of the housing (10), The first end wall (18) and the second end wall (19) on the opposite side, Two side walls (20) join the first end wall (18) to the second end wall (19), Equipped with, The electronic module according to claim 3, in which the capacitive sensor antenna (30) is arranged along a portion of the corner (21) between the first end wall (18) and the rear wall (16), as specified in claim 2.

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

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

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

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

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

10. The printed circuit board comprises a portion (22) having the edge portion (32), The edge portion (32) is arranged along the corner portion (21) defined by the rear wall (16) and the side wall (17), or parallel to the corner portion (21). The portion (22) is attached to the rear wall (16), or is arranged alongside or parallel to the rear wall (16), The electronic module according to claim 7, 8, or 9, where claim 7 is dependent on claim 3, 4, or 5.

11. The electronic unit (11) comprises a controller unit operably connected to the capacitive proximity device (29), The electronic module according to any one of claims 1 to 10, wherein the capacitive proximity device (29) is configured to detect the user's hand holding the electronic module (3) through the capacitive sensor antenna (30) and transmit a signal to the controller unit.

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

13. The electronic unit (11) includes an accelerometer (28), The aforementioned electronic unit (11) When the signal from the capacitive proximity device (29) is received, the controller unit is woken from the sleep state and / or the at least one other sensor or function of the electronic module (3) is activated. Receiving an acceleration signal from the accelerometer (28) indicating that it is ready for use, The electronic module according to claim 12, configured to perform a procedure comprising the following steps.

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

15. The metered-dose spray inhaler (2) disclosed in claim 1, optionally a pressurized spray metered-dose inhaler, An electronic module (3) according to any one of claims 1 to 14, A metered-dose spray inhaler assembly equipped with the following features.

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