Accessory for an inhaler

Abstract

An accessory (100, 605, 950) for obtaining inhalation data of an inhaler is provided. The accessory comprises one or more airflow-induced vibration generators (110, 611, 952) configured to generate mechanical oscillations. The accessory further comprises a monitoring system comprising one or more accelerometer sensors (135) configured to receive the generated mechanical oscillations from the airflow-induced vibration generators and configured to generate acceleration signals based on the received mechanical oscillations. The accessory further comprises an electronic processing unit (350) electrically connected to the accelerometer sensors and configured to receive the generated acceleration signals from the accelerometer sensors and configured to extract inhalation data from the received acceleration signals.

Description

[0001] This disclosure relates to accessories for inhalers.

[0002] This application claims priority to European patent application 24156167.9, filed on February 6, 2024. Background Technology

[0003] Inhalers are the primary treatment for patients with lung diseases such as asthma and chronic obstructive pulmonary disease (COPD). The three main types of inhalers are: metered-dose inhalers (MDI), dry powder inhalers (DPI), and soft mist inhalers (SMI).

[0004] Of all these types of inhalers, the effectiveness of respiratory medication therapy depends particularly on proper inhalation technique. Correct use of the inhaler is crucial, especially in cases where patients need to regularly self-medicate to control their condition.

[0005] Current clinical evidence suggests that inhalation therapy often fails to achieve the desired effect due to poor inhalation technique by patients.

[0006] Some researchers have attempted to address these issues by combining the inhaler with an accelerometer-based device, which generates inhalation data directly from the inhaler by sensing mechanical oscillations during the subject's inhalation. However, such devices may not be optimal for inhalers that do not produce clear and distinguishable mechanical oscillations.

[0007] For example, some inhalers may exhibit weaker mechanical oscillations due to reduced airflow turbulence during inhalation, while other inhalers may be designed to limit the propagation of mechanical oscillations through the inhaler material. The problem of weak mechanical oscillations is further amplified when airflow is low during inhalation, making it difficult to accurately measure airflow characteristics using accelerometer-based devices.

[0008] US2023 / 293830 describes a vibratory delivery device for a capsule-based single-dose dry powder inhaler.

[0009] US2020 / 171251 discloses an accessory for an inhaler that is adapted to be detachably assembled onto the housing of the inhaler.

[0010] US2009308387 describes a dry powder or aerosol inhaler with a sound / vibration sensor detachably attached to it.

[0011] The examples disclosed herein are intended to at least partially alleviate one or more of the aforementioned problems. Summary of the Invention

[0012] According to a first aspect, an accessory for obtaining inhalation data from an inhaler is provided. The accessory includes one or more airflow-induced vibration generators configured to generate mechanical oscillations. The accessory further includes a monitoring system comprising one or more accelerometer sensors configured to receive the generated mechanical oscillations from the airflow-induced vibration generators and configured to generate an acceleration signal based on the received mechanical oscillations. The monitoring system also includes an electronic processing unit electrically connected to the accelerometer sensors, configured to receive the generated acceleration signal from the accelerometer sensors, and configured to extract inhalation data from the received acceleration signal.

[0013] According to this aspect, an accessory is provided for obtaining and / or generating inhalation data related to an inhaler. The accessory is an accelerometer device having a simple and low-cost airflow-induced vibration generator that produces mechanical oscillations with specific characteristics (and thus generates a vibration signal), thereby enabling accurate and reliable measurement of inhalation data, including airflow characteristics, even when the airflow is low during inhalation by a subject using the inhaler. The airflow-induced vibration generator generates detectable and measurable mechanical oscillations in response to airflow through the inhaler, thereby providing highly accurate measurements of inhalation data and airflow characteristics without compromising cost-effectiveness.

[0014] In another aspect, a kit is provided. The kit includes the accessories and inhaler described in the first aspect.

[0015] In some examples, the inhaler is one of the following: a metered-dose inhaler, a dry powder inhaler, or a soft fog inhaler.

[0016] Therefore, the inhaler can be used with three main types of inhalers: metered-dose inhalers (MDI), dry powder inhalers (DPI), and soft fog inhalers (SMI). Attached Figure Description

[0017] Non-limiting examples of this disclosure will now be described with reference to the accompanying drawings, in which: Figure 1 An example of an inhaler and a perspective view of an accessory mounted on the inhaler are shown schematically; Figure 2 schematically shown Figure 1 An exploded view of the inhaler and the accessories mounted on it. Figure 3 schematically shown Figure 1 and Figure 2 Top sectional view of the attached document; Figures 4a-4dThe steps of an example of a method for using an inhaler with the inhaler shown in the foregoing figures are illustrated. Figure 5 Another example of an inhaler and a perspective view of an accessory mounted on the inhaler are schematically shown, wherein the inhaler is in a closed configuration; Figure 6 schematically shown Figure 5 A perspective view of the inhaler and accessories shown, wherein the inhaler is in an open configuration; Figure 7 schematically shown Figure 5 and Figure 6 The attached diagram is an exploded view. Figure 8 schematically shown Figure 5-7 An example of the attachment detection unit and the opening detection unit in the inhaler and accessories shown; Figure 9 A schematic three-dimensional view of yet another inhaler is shown; Figure 10 schematically shown Figure 9 A perspective view of the inhaler shown (including an example of an accessory). Detailed Implementation

[0018] Figure 1 A perspective view schematically illustrates an example of an inhaler 10 and an example of an accessory 100 mounted on the inhaler. In this particular example, the inhaler 10 is a metered-dose inhaler. However, in some other examples, the inhaler 10 may be a dry powder inhaler or a soft fog inhaler.

[0019] The inhaler 10 includes a body 15 for housing a medication canister (not visible in this figure). The medication canister may be made of aluminum or stainless steel. The body 15 includes a mouthpiece 25 through which the atomized contents of the medication canister are dispensed. The formulation itself may consist of a drug, a liquefied gas propellant, and, in many cases, a stabilizing excipient.

[0020] The inhaler 10 also includes a metering valve (not visible) that allows for the dispensing of a measured amount of formulation upon each trigger. The inhaler may also include a cap (not shown) for covering the mouthpiece 25. In this example, accessory 100 may act as a trigger, allowing the user to operate the device and deliver the aerosol into the user's lungs. The body 15 may be equipped with a digital or mechanical dose counter or dose indicator.

[0021] Typically, a metered-dose inhaler operates as follows: the user uses the inhaler by pressing the top of the inhaler while supporting the lower part of the main body with their thumb. Upon activation, the device releases a single dose of formulation containing a drug dissolved or suspended in a propellant. The volatile propellant breaks down into droplets, which then rapidly evaporate, creating an aerosol containing micron-sized drug particles, which are then inhaled. The operation of this particular inhaler 10 will be described in more detail below.

[0022] like Figure 1 As shown, the nozzle 25 can be integrally formed with the body 15. However, in some other examples, the nozzle 25 can be detachably attached to the body 15, allowing the nozzle 25 to be removed. For example, the nozzle 25 can be rotatably or slidably attached to the body 15. The nozzle 25 can be replaced and selected according to desired characteristics.

[0023] As described above, accessory 100 is mounted on inhaler 10. Accessory 100 is configured to measure airflow characteristics, such as the characteristics of the airflow directed to the user's mouth caused by the user inhaling through mouthpiece 25.

[0024] In this example, accessory 100 can be integrally molded with the inhaler body 15. This allows for a relatively simple and more compact design. In some other examples, accessory 100 can be permanently or detachably attached to the inhaler body 15. When the accessory is detachably attached to the inhaler body 15, accessory 100 can be reused with different compatible inhalers. Overall, these configurations provide a flexible and versatile accessory 100 that can be used with a wide variety of inhaler designs. It should be noted that attaching and detaching accessory 100 from the inhaler body 15 can be easily performed by the user without the need for any professional personnel.

[0025] In this example, accessory 100 is configured to be connected to inhaler 10. Figure 2 As shown, accessory 100 includes accessory body 140 and a separate cover 150 for closing the top of accessory body 140. The separate cover 150 can be engaged with accessory body 140 by means of threaded connection or other means.

[0026] The accessory body 140 may include one or more sidewalls 140a extending between a top 140b and a bottom 140c of the accessory body. Space is formed between the sidewalls within the accessory body 140.

[0027] Attachment 100 may also include a base frame 160, which is disposed inside the attachment body 140 during use. The base frame 160 may include a central opening 160a, in which a central support 180 (for supporting the PCB) may be placed.

[0028] In this example, the base frame 160 may include an annular top platform 160b and one or more outer side walls 160c. The base frame 160 may also include one or more slots 160c. The slots form female connecting elements and are adapted to receive and mate with other connecting elements, such as those located in the central support 180. These elements can act as anti-rotation elements, preventing the central support 180 from rotating relative to the base frame 160 during use.

[0029] The base frame 160 may also include one or more airflow-induced vibration generators. In this example, two airflow-induced vibration generators 110a and 110b are provided. The airflow-induced vibration generators 110a and 110b may be attached to a portion of the outer side wall 160c and a portion of the annular top platform 160b. In some other examples, the airflow-induced vibration generators 110a and 110b may be integrally formed with the base frame 160. The structure and operation of the airflow-induced vibration generators 110a and 110b will be described below.

[0030] Continuing with this example, the center support 180 may include a plurality of male (e.g., resilient) connecting members 180a and a top platform 180b. As described above, the center support 180 may be located within a central opening 160a, thus allowing the center support 180 to be held in position within the central opening 160a of the base frame 160. For example, the center support 180 may be attached to the inner wall of the central opening 160a. Furthermore, the male connecting members 180a are adapted to attach to the upper part of the canister. Specifically, the connecting members 180a deform slightly during canister insertion, so that once the canister is installed in the center support 180, the male connecting members resiliently and centripetally press against the canister. With this arrangement, the center support 180 can be releasably engaged with the canister of an inhaler using, for example, a snap-locking mechanism.

[0031] The central support 180 also includes a plurality of elastic elements 180c. These elastic elements are configured to hold the attachment in a first operating position when no pressure is applied to the top of the inhaler. However, if the user uses the inhaler by pressing the top of the inhaler, the elastic elements can bend, causing the attachment to be displaced to a second operating position, in which a single dose of formulation is released. This will be referred to... Figures 4a-4d To describe in more detail.

[0032] See you again Figure 2The accessory 100 may also include a printed circuit board 130 disposed within the accessory body 140 and mechanically coupled to the top platform 180b of the central support 180 (and thus coupled to the accessory body 140). The printed circuit board 130 includes one or more accelerometer sensors 135 electrically (and mechanically) connected to the printed circuit board 130. As will be explained below, the printed circuit board 130 will be affected by mechanical oscillation signals generated by the induced vibration generators 110a, 110b during user inhalation. Typically, the mechanical connection between the printed circuit board 130 and the central support 180 (and thus to the accessory body 140 and the base 160) allows the mechanical oscillations generated by the vibration generators 110a, 110b to propagate, for example, from the accessory's base 160 to the printed circuit board 130 without (significant) attenuation. Such a mechanical connection can be rigid and / or elastic; for example, it can be rigid in some locations and elastic in others.

[0033] Accelerometer 135 may be, for example, a MEMS accelerometer. Each accelerometer may be sensitive to acceleration in one or more directions (e.g., three directions). In this specification and claims, the term "accelerometer" should be understood as a sensor that converts the sensor's own (dynamic and static) acceleration into an electronic signal. Specifically, accelerometer 135 is configured to measure mechanical oscillations generated by an airflow-induced vibration generator as described above. In this respect, the acceleration sensor may be configured to receive the mechanical oscillations generated by the airflow-induced vibration generator and generate an acceleration signal (which will be processed by a processing module).

[0034] The accelerometer can be located at or near the airflow-induced vibration generator, for example, at a distance between 0.1 cm and 5 cm. The inventors have found it advantageous to place the accelerometer relatively close to the airflow-induced vibration generator. This is because the intensity of vibration tends to decrease and decay as it propagates through different materials. The farther the vibration propagates, the more of its original intensity and characteristics are lost. It should be noted that several factors may affect the ideal distance, such as material properties (e.g., dense materials may allow vibrations to propagate further with less loss compared to more porous materials) or the design of intermediate elements.

[0035] In the example, the accelerometer sensor may have a sampling frequency equal to or lower than 2 kHz to accurately process frequencies within the band of interest, specifically between 200 Hz and 900 Hz, from 100 Hz to 1 kHz. Advantageously, such a relatively low sampling frequency allows for reliable generation of intake data while reducing processing and storage requirements and optimizing system power consumption and cost.

[0036] A battery 190 is also provided. The battery 190 can be electrically connected to the printed circuit board 130.

[0037] Annex 100 also includes an inner cover 200 for at least partially closing the top of the airflow-induced vibration generators 110a and 110b. The inner cover extends longitudinally from a first end 200a to a second end 200b. A first cover 210 for at least partially closing the top of the airflow-induced vibration generator 110a and a second cover 220 for at least partially closing the top of the airflow-induced vibration generator 110b are provided at or near the first end 200a. Each cover includes an outer ring 210a, 220a and a central opening 210b, 220b.

[0038] The inner cover 200 also includes one or more pins located at or near the second end 200b of the inner cover. In this particular example, a first pin 230a and a second pin (not visible) are provided. Pin 230a can be configured to be mechanically attached to, for example, soldered to, a printed circuit board 130. Thus, in use, mechanical oscillations generated by the airflow-induced vibration generators 110a, 110b can be amplified and transmitted from the first cover 210 and the second cover 220 that close the respective airflow-induced vibration generators 110a, 110b to the printed circuit board 130 (and thus to the accelerometer 135 that is electrically and mechanically connected to the printed circuit board 130).

[0039] like Figure 3 As shown, the accessory body 140 (and the corresponding airflow-induced vibration generator) may include one or more air inlets 230a, 230b, configured to receive airflow generated by a user applying suction to the mouthpiece of the inhaler in the direction of the arrow (arrow A), and to introduce this airflow into the accessory 100, specifically into the airflow-induced vibration generators 110a, 110b. In particular, each air inlet 230a, 230b is configured to direct the airflow to the corresponding airflow-induced vibration generator 110a, 110b. The air inlets 103a, 103b may have different sizes. The larger the size or the greater the number of air inlets, the lower the resistance provided by the inhaler 100 to inhalation. This provides suitable resistance to inhalation. In this particular example, two air inlets 230a, 230b are provided.

[0040] The accessory body 140 may also include an air outlet (not visible) configured to deliver airflow previously received in the accessory 100 via air inlets 230a, 230b to the user for inhalation.

[0041] As described above, Annex 100 includes one or more airflow-induced vibration generators 110a, 110b. In this particular example, two airflow-induced vibration generators 110a, 110b are depicted. Airflow-induced vibration generator 110a can be activated by airflow through a corresponding air inlet and can be configured to generate mechanical oscillations. The airflow-induced vibration generators can be located anywhere on the base of Annex 100, as long as they are near the accelerometer.

[0042] Specifically, the airflow-induced vibration generator 110b may include an airflow-induced vibration generator chamber 111 that houses one or more rotating elements, in this example, a rotating element 112. The rotating element 112 is a component capable of moving in response to airflow through the chamber 111 during patient inhalation. In this respect, the rotating element 112 can move freely within the vibration generator chamber 111. The rotating element 112 is configured to interact with the inner surface of the enclosed chamber 111, thereby generating mechanical oscillations.

[0043] In some other examples, not shown, guide pins may be provided to guide the rotating element within the vibration generator chamber 111. The vibration generator chamber 111 may also include elements (not shown) configured to interfere with the movement of the rotating element, thereby amplifying the vibrations induced by the rotating element.

[0044] In use, the patient's inhalation through the suction nozzle causes airflow to enter the airflow-induced vibration generator chamber 111 via the air inlet 230b in the direction of the arrow (arrow A). The tangential airflow causes the rotating element 112 housed in chamber 111 to rotate. This generates mechanical oscillations and thus a vibration signal. These mechanical oscillations can occur via, for example, the sidewall of the base frame (not visible in this figure, but shown in...). Figure 2 (See component 160) and the pin of the inner cover (not visible in this figure, but shown in) Figure 2 (See component 200) is transmitted to printed circuit board 130 (and thus to accelerometer 135 electrically connected to the printed circuit board).

[0045] In this example, the rotating element 112 is a spherical ball, but it can also be some other rotating element, such as a bone-shaped rotating element, a T-shaped rotating element, or a helix.

[0046] In this example, a single air inlet 230b is connected to the corresponding airflow-induced vibration generator chamber 111. However, in some other examples, two or more air inlets may be connected to the corresponding airflow-induced vibration generator chamber 111.

[0047] In some other examples not shown, the airflow-induced vibration generator 110b may include an annular raceway that houses a rotating element, such as a spherical ball, which is capable of free movement along a circular path under the influence of airflow passing through the air inlet 230b of the airflow-induced vibration generator 110b. The air inlet 230b may include a smooth quadrilateral aperture and may be tangentially oriented relative to the annular raceway. The interaction between the spherical ball and the annular raceway can generate mechanical oscillations.

[0048] To enhance the mechanical oscillations of the spherical balls during their circular path motion, the vibration generator may further include components disposed within the annular raceway, which the spherical balls contact as they move due to airflow. Alternatively, the vibration generator may include multiple spherical balls within the annular raceway that interact both with the raceway and with each other.

[0049] In some other examples not shown, the rotating element of the airflow-induced vibration generator may be a propeller (not shown). The propeller may be designed to rotate when airflow is introduced into the vibration generator chamber of the airflow-induced vibration generator via an air inlet. In this example, the air inlet may be positioned and oriented perpendicular to the axis of rotation of the propeller.

[0050] Airflow-induced vibration generator 110a may have the same structure as airflow-induced vibration generator 110b. However, the difference between airflow-induced vibration generator 110a and airflow-induced vibration generator 110b is that airflow-induced vibration generator 110a does not include a rotating element. Therefore, airflow-induced vibration generator 110b can be a “pseudo” airflow-induced vibration generator, included to reduce the airflow resistance provided by inhaler 10 during user inhalation via mouthpiece, and thus does not include a rotating element. In this respect, the lower the airflow resistance of accessory 100, the higher the inhalation airflow required to displace (and thus rotate) the rotating element.

[0051] It should be noted that the vibration signal generated by the airflow-induced vibration generator can have a signal-to-noise ratio (SNR) equal to or greater than 4:1. This ratio is determined by the root mean square error (RMSE) of the vibration signal and may become more favorable as the strength of the inhaled airflow increases. A higher SNR indicates that the vibration signal is stronger and more easily distinguishable relative to any background noise or interference present in the measurement.

[0052] In the example, the (detrended) vibration signal can exhibit a dominant frequency above 100 Hz, specifically between 200 Hz and 400 Hz. The inventors discovered that by providing a vibration signal focused within this range, Annex 100 optimizes its sensitivity in capturing major vibrations associated with airflow.

[0053] In the example, the spectral power associated with the dominant frequency of the vibration signal between 200 Hz and 400 Hz can be positive, and specifically at least five times the spectral power of the vibration signal in the absence of external excitation (noise). This criterion ensures that a significant portion of the signal energy is concentrated within the desired frequency range, thereby contributing to the accurate interpretation of airflow characteristics.

[0054] In some other examples, a significant portion of the total spectral energy of the vibration signal is concentrated within a 100Hz bandwidth centered on the dominant frequency. Specifically, at least 50% of the spectral energy of the vibration signal is concentrated within this 100Hz bandwidth. More specifically, 75% of the spectral energy of the vibration signal falls within this bandwidth. This energy concentration ensures that the most relevant and informative components of the vibration signal are captured.

[0055] Annex 100 (particularly the monitoring system) may also include a detection unit 300 arranged to detect triggering of the inhaler to dispense a predetermined amount of formulation to be expelled. For example, as will be explained below, the detection unit 300 may include a mechanical switch configured to be activated upon triggering of the inhaler. The detection unit is configured to generate a first signal upon activation (and thus upon triggering of the inhaler). An electronic processing unit 350 may be configured to receive from the detection unit a signal indicating that the inhaler has been triggered, thereby confirming that the inhaler has been triggered.

[0056] Annex 100 may further include an electronic processing unit 350 electrically connected to the printed circuit board 130. The electronic processing unit 350 is configured to receive acceleration signals from the accelerometer 135 and to receive signals when the detection unit 300 is activated. Receipt of a signal from the detection unit can trigger the electronic processing unit to process the signal from the accelerometer to generate intake data. In this example, the accelerometer 135 and the electronic processing unit 350 may remain in a sleep or low-power mode and be activated by a signal from the detection unit 300. This allows the detection unit 300 to optimize signal processing and battery consumption.

[0057] The detection unit 300 may also be configured to generate a signal when it detects an airflow generated by a user applying suction to the mouthpiece of the inhaler. For example, the detection unit 300 may include a sensor configured to be activated once the user applies suction to the mouthpiece and generates an airflow.

[0058] The electronic processing unit 350 is configured to receive from the detection unit a signal indicating that an airflow generated by the user applying suction to the mouthpiece of the inhaler has been detected, and to confirm that the start of inhalation has been detected.

[0059] The electronic processing unit 350 can also be configured to confirm whether a signal indicating that the inhaler has been triggered has been received before detecting the first signal of airflow generated by the user applying inhalation to the mouth of the inhaler. This indicates whether the user can effectively synchronize the inhalation action with the inhaler's triggering process. Generally, the best drug delivery effect is obtained when the user begins inhaling slightly before triggering the inhaler and continues inhaling for a period of time after triggering.

[0060] The electronic processing unit 350 can also be configured to recognize the moment when a signal indicating that an airflow generated by the user applying inhalation to the mouthpiece of the inhaler is detected is received. The electronic processing unit 350 is also configured to recognize the moment when a signal indicating that the inhaler has been triggered is received. The electronic processing unit 350 can also be configured to determine the time difference between receiving the signal indicating that the inhaler has been triggered and receiving the signal indicating that an airflow has been generated. For example, if the time difference between the signal indicating that an airflow has been generated and the subsequent inhaler trigger is in the range of 0.1 to 1 second (specifically, not exceeding 0.5 seconds), it can be determined that the user has effectively synchronized their inhalation action with the triggering of the inhaler.

[0061] The processor can also be configured to determine whether the time difference between the moment when a signal indicating the detection of airflow generated by the user is received and the moment when the signal is no longer received is within (or above) a threshold. For example, if the time difference after the inhaler is triggered is between 2 and 5 seconds (or above 2.5 seconds), it can be determined that the user has inhaled for a sufficient duration.

[0062] The electronic processing unit 350 is configured to process signals from the accelerometer in order to provide inhalation data and estimate one or more airflow characteristics based on vibrations generated by the airflow vibration generator.

[0063] These parameters can be, for example, the intake air volume (the air inhaled during a single intake), peak intake flow rate (the maximum airflow rate during intake), intake duration (the length of time intake is complete), and intake acceleration (the rate of change of airflow during intake).

[0064] In this example, the electronic processing unit 350 can also be configured to estimate or evaluate the aforementioned parameters based on the mechanical and / or design characteristics of the inhaler. Specifically, when estimating these parameters, the electronic processing unit 350 may take into account the characteristics of the inhaler body 140, the mouthpiece 25, and / or the printed circuit board 130, such as the geometry and / or arrangement of each of these components. For example, the specific configuration of the inhaler body 140 and / or the air inlets 230a, 230b may be considered. These characteristics may, for example, be pre-stored in a memory electrically connected to the electronic processing unit.

[0065] Annex 100 may further include a transceiver unit 400 electrically connected to a printed circuit board 130. The transceiver unit is configured to enable at least one radio communication with one or more external electronic devices, such as smartphones or remote servers. Such radio communication may use standards in short-range dependent protocols for communication over WPANs (including BLE, Bluetooth 5, and IEEE 802.15.4 and all variants thereof) and WLANs (including IEEE 802.11 and all variants thereof), or a direct internet connection using long-range dependent protocols (including LoRaWAN, SigFox, EC-GSM, LTE, NPlio, LTE-M and all variants thereof) without the need for an internet gateway. The transceiver unit may be configured to wirelessly exchange incoming data generated by the processing unit.

[0066] Figures 4a-4d The diagram schematically illustrates a series of scenarios that may occur during the operation of a metered-dose inhaler with the attached accessories as described above. The same reference numerals denote the same elements. See below for further details. Figures 4a-4d The sequence of scenarios shown describes this method.

[0067] Figure 4a The initial configuration is shown. In this initial configuration, no pressure is applied to the top of the inhaler (specifically, the upper surface of the accessory cover 150) in the direction of the arrow (arrow B). Therefore, the accessory cover 150 is held in the first operating position via the elastic element of the central support. Typically, the lower surface of the cover can rest on one end of the elastic element 155, so that the cover does not contact the lever 300a that forms part of the detection unit 300.

[0068] exist Figure 4b In this configuration, the top of the accessory (specifically, the upper surface of the accessory cover 150) has been pressed in the direction of the arrow (arrow B), while the user's thumb supports the lower part of the inhaler body. Consequently, the elastic element 155 has been bent, and the first sub-assembly, comprising the cover 15, accessory body, base frame (not visible in this figure), and inner cover (not visible in this figure), has been displaced relative to the second sub-assembly of the inhaler in the direction of the arrow (arrow B) until it reaches the intermediate operating position. The second sub-assembly includes a central support, a printed circuit board, and a battery.

[0069] Once the intermediate operating position is reached, the lower part of the cover 150 contacts the lever 300a, which forms part of the detection unit 300 (electrically connected to the PCB), thereby generating a signal by the detection unit 300. This signal can be received by an electronic processing unit, which forms part of the printed circuit board, and can trigger the electronic processing unit to process the signal from the accelerometer to generate suction data. Essentially, the function of the lever 300a and the detection unit 300 is to "wake up" the accessory and inform it that suction may have occurred or may have already occurred within a certain time interval since the switch was activated.

[0070] exist Figure 4c In the middle, the top of the accessory has been further pressed in the direction of the arrow (arrow B), while the user's thumb supports the lower part of the main body. The first sub-group element is further displaced relative to the second sub-group element until the lower part of the cover 150 reaches the upper part of the post 155 that forms part of the central support 180 (four posts in this example, although in Figure 4c Only one column is visible in the middle.

[0071] exist Figure 4d In this case, the top of the attachment has been pressed further in the direction of the arrow (arrow B), while the user's thumb supports the lower part of the main body. This causes the attachment 100 to shift as a single entity in the direction of the arrow (arrow B). Therefore, pressure is applied to the upper part of the canister, thereby triggering the inhaler.

[0072] The inhaler triggers the release of a single dose of formulation containing a drug dissolved or suspended in a propellant. The volatile propellant breaks down into droplets, which then rapidly evaporate, creating an aerosol containing micron-sized drug particles, which are then inhaled.

[0073] In the example, the user's inhalation (which can trigger the rotation of the ball, and thus trigger the vibration detected by the accelerometer as previously described) can occur almost in parallel with, or slightly earlier than, the activation of the accessory and the triggering of the inhaler.

[0074] Figure 5 A perspective view schematically illustrates another example of an inhaler in a closed configuration and another example of an accessory mounted on the inhaler. Figure 6 A perspective view schematically shows an inhaler in an open configuration and the same accessory mounted on it.

[0075] In this particular example, inhaler 600 is a dry powder inhaler. This inhaler can be substantially similar to the "ELLIPTA" inhaler. Figure 6As shown, the inhaler 600 includes a body enclosed by a housing 601 and a mouthpiece 604. The housing 601 includes an air inlet 603 configured to receive an airflow generated by a user applying suction to the mouthpiece 604 of the inhaler.

[0076] The inhaler 600 also includes an accessory 605, which may be detachably attached to the inhaler 600 or integrally formed with the inhaler. The accessory 605 is configured to measure airflow characteristics, such as the characteristics of the airflow directed to the user's mouth caused by inhalation through the mouthpiece 604. These characteristics are the same as those described in the foregoing examples.

[0077] See Figure 7 Attachment 605 includes a sliding cover assembly 680, which includes an upper curved wall 606, a first side wall 607, and a second side wall 608.

[0078] The first sidewall 607 may include a central opening 616 in which the printed circuit board 609, as described above, is located. A battery 610, as described above, is also provided. The battery 610 may be electrically connected to the printed circuit board 609. The accessory 605 may also include one or more airflow-induced vibration generators 611 having an airflow-induced vibration generator chamber 611a, as described above, that accommodates one or more rotating elements 612.

[0079] In this example, a single airflow-induced vibration generator 611 is located at or near the first end 607a of the first sidewall 607. The airflow-induced vibration generator 611 includes an air inlet 613 configured to receive, during use, an airflow generated by a user applying suction to the mouthpiece of the inhaler and direct that airflow to the rotating element 612. A separate cover or cap 614 may also be provided for closing the top surface of the first sidewall 607 of the sliding cover assembly 680 (and thus the accessory).

[0080] The sliding cap assembly 680 (and thus accessory 605) can be mounted on the inhaler housing 601, from which... Figure 5 The upper curved wall 652 shown covers the closed position of the suction nozzle 604 and pivots to, as shown Figure 6 The exposed nozzle 604 is shown in its open position. The sliding cover assembly 680 (and thus accessory 605) is from... Figure 5 The closed position shown Figure 6 The opening movement of the shown open position can cause the inhaler 600 to be loaded, i.e., to prepare a drug blister for subsequent administration by inhalation. In the example, the blister with the corresponding drug dose can be placed within the housing 601 of the inhaler 600 during the manufacture of the inhaler 600.

[0081] Furthermore, when the sliding cover assembly 680 (and thus accessory 605) is in the open position ( Figure 6When the air inlet 603, which forms part of the housing 601, is connected to the airflow-induced vibration generator (not visible in this figure, but shown in...),... Figure 7 The air intake 613 (not visible in this figure, but shown in) Figure 7 Alignment. Therefore, the air inlet 613 of the airflow-induced vibration generator is configured to receive airflow generated by the user applying suction to the mouthpiece 604 of the inhaler via the air inlet 603, and direct this airflow to the rotating element 612. Similar to the foregoing example, the airflow-induced vibration generator can be activated by the airflow through the corresponding air inlet 613 and can be configured to generate mechanical oscillations. The accessory may include a monitoring system having the structure and operation described above. In short, the electronic processing unit (see [reference]) forming part of the printed circuit board 609... Figure 7 It can process acceleration signals from accelerometer sensors (which are generated based on mechanical oscillations received by the accelerometer sensors) and obtain inhalation data (e.g., estimate one or more airflow characteristics) based on these received signals.

[0082] like Figure 6 As shown, on the upper surface 601a of the inhaler housing (as the sliding cover assembly (and thus the accessory) moves from the closed position to the open position), the air inlet of accessory 605 (not visible in this figure, but...) Figure 8 (As can be seen) sliding on this upper surface can include different upper surface heights, i.e., heights closer to or farther from the center of the inhaler. For example, surface 601aa and surface 601ab are at different heights.

[0083] In order to allow the air inlet of the accessory (in) when the sliding cover assembly 680 moves from the closed position to the open position. Figure 6 Invisible in the middle, but in Figure 7 As can be seen from the attached drawing (reference numeral 613), the first end 607a of the first sidewall 607 of the accessory (and thus the air inlet of the accessory) can be elastically pressed against the surface of the housing 601, i.e., the first end is held in place by elastic force. Therefore, during the sliding of the accessory between the open and closed positions, the first end 607a of the first sidewall 607 of the accessory (and thus the air inlet 613 of the airflow-induced vibration generator) remains properly pressed against the surface of the housing.

[0084] Specifically, when the accessory is in the open position, the airflow-induced vibration generator (in) Figure 6 Invisible in the middle, but in Figure 7 The air intake 613 (as shown by reference numeral 611 in the attached figure) is located in the figure. Figure 6 Invisible in the middle, but in Figure 7(As can be seen with reference numeral 613 in the attached figure) Keep it properly pressed against the air inlet 603 of the inhaler. This is important to ensure that no air leakage occurs during air transfer between the respective air inlets.

[0085] In the example, the above appropriate fit can be achieved using one or more spring elements (e.g., steel springs or plastic springs).

[0086] In some other examples, the first end 607a of the first sidewall 607 of the attachment may be designed with a suitable flexible material so that during the sliding of the attachment between the open and closed positions, the first end 607a of the first sidewall 607 of the attachment (and thus the air inlet 613 of the airflow-induced vibration generator 611) remains properly pressed against the surface of the housing.

[0087] Suitable materials can possess good elastic properties and high yield strength. These materials can be metals (e.g., steel) or plastic resins (e.g., polyoxymethylene).

[0088] like Figure 8 As shown, accessory 100 may also include an attachment detection unit 690, which is arranged to detect the fact that the accessory has been attached to the inhaler. For example, detection unit 690 may include a mechanical switch configured to be activated when the accessory is attached to the inhaler. Figure 8 In the diagram, attachment detection unit 690 is shown in an active state. Attachment detection unit 690 is configured to generate a signal once the attachment has been attached to the inhaler. This signal can be processed by the processing unit.

[0089] The accessory may also include an open / close detection unit 691, which is arranged to detect whether the accessory is in an open or closed position. For example, the detection unit may include a mechanical switch configured to be activated when the accessory is in the closed position (i.e., the switch is pressed against the upper surface of the inhaler housing: see...). Figure 8 The switch is configured to be deactivated when the accessory is in the open position (i.e., the switch is not pressed against the upper surface of the inhaler housing). The open / close detection unit 691 is configured to generate a signal once the accessory is pressed against the upper surface of the inhaler housing.

[0090] Figure 9 A 3D view of yet another inhaler is shown schematically. Figure 10 A perspective view of the inhaler and accessories mounted on it is shown schematically.

[0091] In this particular example, inhaler 900 is a soft mist inhaler. This inhaler corresponds to a nebulizer used for atomizing fluids (invisible), particularly highly effective pharmaceutical compositions, etc. This nebulizer is specifically constructed as a portable inhaler.

[0092] When a fluid (invisible) (preferably a liquid, more particularly a pharmaceutical composition) is nebulized, it forms an aerosol that can be inhaled or breathed by a user (not shown). Typically, inhalation is performed at least once a day, more particularly several times a day, preferably at set intervals. The nebulizer has an insertable and preferably replaceable container (invisible) that holds the fluid, forming a reservoir for the fluid to be nebulized.

[0093] The atomizer has a pressure generator for delivering and atomizing the fluid, particularly delivering and atomizing the fluid at a preset and optionally adjustable dose. A user (not shown) can inhale the aerosol while supplied air is drawn into the mouthpiece 901 through at least one air supply opening 905.

[0094] The attachment described above can be installed. Before installing the attachment, the cap (not shown) covering the mouthpiece 901 can be removed. Once the cap is removed, the attachment 950 can be installed at or near the mouthpiece of the inhaler and on the support 951.

[0095] Similar to the previous example, Annex 950 includes an airflow-induced vibration generator 952, which includes an air inlet 953 configured to receive, during use, an airflow generated by a user applying suction to the mouthpiece of the inhaler via an air supply opening 905, and direct that airflow to a corresponding rotating element. The corresponding air inlets can be aligned. These mechanical vibrations generated by the rotating element can be transmitted to a printed circuit board (not shown) and the accelerometer sensor. An electronic processor can receive the generated acceleration signal from the accelerometer sensor and extract inhalation data from the received acceleration signal.

[0096] For completeness, various aspects of this disclosure are set forth in the following numbered clauses: Clause 1. An accessory for obtaining inhalation data from an inhaler, wherein the accessory is integrally formed with or attachable to the inhaler, the accessory comprising: One or more airflow-induced vibration generators are configured to produce mechanical oscillations. The monitoring system includes: One or more accelerometer sensors are configured to: The mechanical oscillations generated are received from the airflow-induced vibration generator. Acceleration signals are generated based on the received mechanical oscillations. An electronic processing unit, electrically connected to the accelerometer sensor, is configured to: The acceleration signal generated is received from the accelerometer sensor. Inhalation data is extracted from the received acceleration signal.

[0097] Clause 2. As per the annex described in Clause 1, the inhalation data are one or more of the following: Inhalation flow rate; Inhalation volume; Peak inhalation flow rate; Inhalation duration.

[0098] Clause 3. An appendix according to any one of Clauses 1-2, wherein the appendix comprises an appendix body having one or more sidewalls extending between the top and bottom of the appendix body, and a space is formed between the sidewalls inside the container body.

[0099] Clause 4. The annex as described in Clause 3, wherein the annex includes a base frame disposed in use within the space formed within the body of the annex, wherein the base frame includes an annular top platform and one or more outer side walls, the annular top platform including a central opening configured to receive a central support member, wherein the airflow-induced vibration generator forms part of the base frame.

[0100] Clause 5. An appendix to any one of Clauses 1-4, wherein at least one of the airflow-induced vibration generators includes an airflow-induced vibration generator chamber, the airflow-induced vibration generator chamber including one or more rotating elements, wherein the rotating elements are configured to interact with an inner surface of the airflow-induced vibration generator chamber to generate mechanical oscillations.

[0101] Clause 6. The appendix as described in Clause 5, wherein the airflow-induced vibration generator includes one or more air inlets configured to receive airflow generated by a user applying suction to the mouthpiece of an inhaler, wherein the air inlets are further configured to direct the received airflow into the interior of a corresponding airflow-induced vibration generator chamber, thereby causing the rotating element to move to interact with the inner surface of the airflow-induced vibration generator chamber.

[0102] Clause 7. An appendix to any one of Clauses 1-6, wherein at least one of the airflow-induced vibration generators does not include a rotating element.

[0103] Clause 8. The appendix according to any one of Clauses 3-7, wherein the monitoring system further comprises a printed circuit board mechanically coupled to the body of the appendix, wherein the electronic processing unit and the accelerometer sensor are electrically connected to the printed circuit board, wherein the printed circuit board is configured to transmit mechanical oscillations from the inhaler body to the accelerometer sensor.

[0104] Clause 9. The annex as described in Clause 8, wherein the connection between the printed circuit board and the body of the annex is rigid and / or resilient.

[0105] Clause 10. The appendix according to any one of Clauses 5-9 further includes an inner cover configured to at least partially enclose the vibration generator chamber of the airflow-induced vibration generator.

[0106] Clause 11. The appendix according to Clause 10, wherein the inner cover extends from a first end to a second end, wherein the second end includes one or more pins configured to mechanically attach to the printed circuit board, thereby transmitting mechanical oscillations from the airflow-induced vibration generator to the printed circuit board.

[0107] Clause 12. An appendix to any one of Clauses 1-11, wherein the monitoring system includes a detection unit configured to generate a signal when the inhaler is triggered to dispense a predetermined amount of formulation to be expelled, and the processing unit is configured to receive from the detection unit the signal indicating that the inhaler has been triggered.

[0108] Clause 13. An appendix to any one of Clauses 1-12, wherein the monitoring system includes a detection unit configured to generate a signal upon detecting an airflow generated by a user applying suction to the mouthpiece of the inhaler, and the processing unit configured to receive from the detection unit the signal indicating that an airflow generated by a user applying suction to the mouthpiece of the inhaler has been detected. Clause 14. The annex described in Clause 13, which is subordinate to Clause 12, wherein the processing unit is configured to: identify the moment when a signal indicating that an airflow generated by a user applying suction to the mouthpiece of the inhaler is detected, identify the moment when a signal indicating that the inhaler has been triggered is received, and determine the time difference between the moment when the signal indicating that the inhaler has been triggered is received and the moment when the signal indicating that an airflow has been detected is received.

[0109] Clause 15. The annex as described in Clause 14, wherein the processing unit is further configured to: determine whether the time difference is within a time interval, specifically the time interval falling within the range of 0.1 to 1 second.

[0110] Clause 16. An appendix to any one of Clauses 1-2 and 5-6, wherein the appendix includes a sliding cover assembly comprising an upper curved wall, a first sidewall, and a second sidewall.

[0111] Clause 17. The annex of Clause 16, wherein the monitoring system further includes a printed circuit board mechanically coupled to the first sidewall, wherein the electronic processing unit and the accelerometer sensor are electrically connected to the printed circuit board, wherein the printed circuit board is configured to transmit vibration signals from the first sidewall to the accelerometer sensor.

[0112] Clause 18. The appendix according to any one of Clauses 16-17, wherein the airflow-induced vibration generator is located at or near the first end of the first sidewall.

[0113] Clause 19. An appendix to any one of Clauses 16-18, wherein the sliding cap assembly is configured to shift between a closed position in which the upper curved wall covers the mouthpiece of the inhaler and an open position in which the upper curved wall does not cover the mouthpiece of the inhaler.

[0114] Clause 20. The appendix described in Clause 19, which is subordinate to Clause 6, wherein when the sliding cover is in the open position, the air inlet of the corresponding airflow-induced vibration generator is aligned with the air inlet located in the housing of the inhaler.

[0115] Clause 21. According to the appendix of Clause 20, the respective air inlet of the airflow-induced vibration generator is configured to receive, via the air inlet located in the housing of the inhaler, an airflow generated by the user applying suction on the mouthpiece of the inhaler, and direct the airflow to the airflow-induced vibration generator.

[0116] Clause 22. An accessory according to any one of Clauses 18-21, wherein a first end of the first sidewall of the accessory is resiliently pressed against the surface of the inhaler housing.

[0117] Clause 23. An appendix to any one of Clauses 16-22, wherein the monitoring system further comprises an attachment detection unit configured to generate a signal once the attachment has been attached to the inhaler, and the electronic processing unit is configured to receive the signal generated by the attachment detection unit to detect the attachment of the attachment.

[0118] Clause 24. An appendix to any one of Clauses 16-23, wherein the monitoring system further comprises an opening detection unit configured to generate a signal once the sliding cover is in a closed position, and the electronic processing unit is configured to receive the signal generated by the attached detection unit to detect the closed position of the sliding cover.

[0119] Clause 25. A kit comprising: an accessory according to any one of Clauses 1-24, and an inhaler.

[0120] Clause 26. The kit described in Clause 25, wherein the inhaler is one of the following: a metered-dose inhaler, a dry powder inhaler, or a soft fog inhaler.

[0121] Although only a few examples have been disclosed herein, other alternatives, modifications, uses, and / or equivalents are possible. Furthermore, all possible combinations of the described examples are also included. Therefore, the scope of this disclosure should not be limited to the specific examples, but should be determined solely by a reasonable interpretation of the appended claims.

Claims

1. An accessory for obtaining inhalation data from an inhaler, the accessory comprising: One or more airflow-induced vibration generators, the airflow-induced vibration generators being configured to generate mechanical oscillations. The monitoring system includes: One or more accelerometer sensors, the accelerometer sensors being configured to: The mechanical oscillations generated are received from the airflow-induced vibration generator. Acceleration signals are generated based on the received mechanical oscillations. An electronic processing unit, electrically connected to the accelerometer sensor, is configured to: The acceleration signal generated is received from the accelerometer sensor. Inhalation data is extracted from the received acceleration signal.

2. The appendix according to claim 1, wherein the inhalation data are one or more of the following: Inhalation flow rate; Inhalation volume; Peak inhalation flow rate; Inhalation duration.

3. The accessory according to any one of claims 1-2, wherein the accessory comprises an accessory body having one or more sidewalls extending between the top and bottom of the accessory body, and a space is formed between the sidewalls inside the container body.

4. The accessory of claim 3, wherein the accessory includes a base frame disposed in the space formed within the body of the accessory during use, wherein the base frame includes an annular top platform and one or more outer side walls, the annular top platform including a central opening configured to receive a central support member, wherein the airflow-induced vibration generator forms part of the base frame.

5. The appendix according to any one of claims 1-4, wherein at least one of the airflow-induced vibration generators includes an airflow-induced vibration generator chamber, the airflow-induced vibration generator chamber including one or more rotating elements, wherein the rotating elements are configured to interact with the inner surface of the airflow-induced vibration generator chamber to generate mechanical oscillations.

6. The appendix of claim 5, wherein the airflow-induced vibration generator includes one or more air inlets configured to receive airflow generated by a user applying suction to the mouthpiece of an inhaler, wherein the air inlets are further configured to direct the received airflow into the interior of a corresponding airflow-induced vibration generator chamber, thereby causing the rotating element to move to interact with the inner surface of the airflow-induced vibration generator chamber.

7. The appendix according to any one of claims 1-6, wherein at least one of the airflow-induced vibration generators does not include a rotating element.

8. The accessory according to any one of claims 3-7, wherein the monitoring system further comprises a printed circuit board mechanically coupled to the accessory body, wherein the electronic processing unit and the accelerometer sensor are electrically connected to the printed circuit board, wherein the printed circuit board is configured to transmit mechanical oscillations from the inhaler body to the accelerometer sensor.

9. The attachment according to claim 8, wherein the connection between the printed circuit board and the attachment body is rigid or elastic.

10. The accessory according to any one of claims 5-9, further comprising an inner cover configured to at least partially enclose the vibration generator chamber of the airflow-induced vibration generator.

11. The accessory of claim 10, wherein the inner cover extends from a first end to a second end, wherein the second end includes one or more pins configured to mechanically attach to the printed circuit board, thereby transmitting mechanical oscillations from the airflow-induced vibration generator to the printed circuit board.

12. The appendix of any one of claims 1-11, wherein the monitoring system includes a detection unit configured to generate a signal when the inhaler is triggered to dispense a certain amount of formulation to be expelled, and the processing unit is configured to receive from the detection unit the signal indicating that the inhaler has been triggered.

13. The appendix of any one of claims 1-12, wherein the monitoring system includes a detection unit configured to generate a signal when an airflow is detected by a user applying suction to the mouthpiece of the inhaler, and the processing unit is configured to receive from the detection unit the signal indicating that an airflow is detected by a user applying suction to the mouthpiece of the inhaler.

14. The appendix according to claim 13, which is dependent on claim 12, wherein the processing unit is configured to: identify the moment when a signal indicating that an airflow generated by a user applying suction to the mouthpiece of the inhaler is detected, identify the moment when a signal indicating that the inhaler has been triggered is received, and determine the time difference between the moment when the signal indicating that the inhaler has been triggered is received and the moment when the signal indicating that an airflow has been detected is received.

15. The appendix according to claim 14, wherein the processing unit is further configured to: determine whether the time difference is within a time interval, specifically the time interval falling within the range of 0.1 to 1 second.

16. The accessory according to any one of claims 1-2 and 5-6, wherein the accessory includes a sliding cover assembly, the sliding cover assembly including an upper curved wall, a first side wall and a second side wall.

17. The appendix according to any one of claims 16, wherein the airflow-induced vibration generator is located at or near the first end of the first sidewall.

18. The appendix according to any one of claims 16-17, wherein the sliding cap assembly is configured to shift between a closed position in which the upper curved wall covers the mouthpiece of the inhaler and an open position in which the upper curved wall does not cover the mouthpiece of the inhaler.

19. The appendix according to claim 18, which is dependent on claim 6, wherein, When the sliding cover is in the open position, the air inlet of the corresponding airflow-induced vibration generator is aligned with the air inlet located in the housing of the inhaler.

20. The appendix of claim 19, wherein the corresponding air inlet of the airflow-induced vibration generator is configured to receive, via the air inlet located in the housing of the inhaler, an airflow generated by a user applying suction to the mouthpiece of the inhaler, and direct the airflow to the airflow-induced vibration generator.

21. The accessory according to any one of claims 17-20, wherein a first end of the first sidewall of the accessory is elastically pressed against the surface of the inhaler housing.

22. The accessory according to any one of claims 16-21, wherein the monitoring system further comprises an attachment detection unit configured to generate a signal once the accessory has been attached to the inhaler, and the electronic processing unit is configured to receive the signal generated by the attachment detection unit to detect the attachment of the accessory.

23. The appendix of any one of claims 16-22, wherein the monitoring system further comprises an opening detection unit configured to generate a signal once the sliding cover is in a closed position, and the electronic processing unit configured to receive the signal generated by the opening detection unit to detect the closed position of the sliding cover.

24. The accessory according to any one of claims 1-21 and 23, wherein the accessory is integrally formed with the inhaler.

25. The accessory according to any one of claims 1-23, wherein the accessory is adapted to be releasably attached to an inhaler.

26. A kit comprising: The accessory and inhaler according to any one of claims 1-25.

27. The kit of claim 26, wherein the inhaler is one of the following: a metered-dose inhaler, a dry powder inhaler, or a soft fog inhaler.

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