Inhalation system

Abstract

It is an intake system. An inhalation device operable to deliver a dose of an inhaled active ingredient includes a housing having a mouthpiece, a removable flow regulator supported at least in part within the housing, the flow regulator having a cavity for receiving a container containing the active ingredient, and an electronic component for monitoring inhalation data and transmitting the inhalation data to a remote device. The inhalation system includes both the inhalation device and the inhalation cap, and a computer program application, when running on a client device, causes the client device to receive the inhalation data from the electronic component.

Description

[Technical Field]

[0001] The present invention relates to inhaler devices, such as metered dose inhaler devices, dry powder inhaler devices, and soft mist inhaler devices. The present invention relates particularly, but not exclusively, to inhalation devices having an "electronic component" capable of communicating with an external client device. Such inhalation devices are sometimes referred to as "smart inhalers" and can also be used in an inhalation system that includes an inhalation device and an external client device that communicates with the inhalation device. [Background technology]

[0002] An inhaler is a medical device that delivers medication, usually in the form of a powder or liquid (such as an aerosol or mist), into the body via the lungs. Such devices are primarily used to treat respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). However, the inhalation device can be used to deliver any inhaled medication (e.g., aerosolized pain relievers, medical marijuana, breath fresheners, etc.).

[0003] A typical inhalation device comprises a "housing" that receives a vessel containing one or more doses of medication to be delivered. In the case of a metered dose inhaler, such a container is typically a "canister," which operates to deliver a dose of a substance (eg, a medication) held therein. In dry powder inhalation devices, such a container may comprise a "blister" containing a single dose of powdered medication, or a "reservoir" containing multiple doses of such powdered medication. In soft mist inhaler devices, such containers are equipped with "cartridges" that contain multiple doses of liquid medication. In each case, the general housing includes a "mouthpiece." In use, the user of the inhaler triggers the inhaler by pressing a button on the housing, by pressing the canister itself (in the case of metered dose inhalers), or by twisting the cartridge (in the case of soft mist inhalers) to deliver a dose of medication. The user then inhales the aerosolized dose of substance / medication through the mouthpiece. Some inhalation devices are activated by the user inhaling to deliver a dose (such inhalation devices are called breath-actuated inhalation devices).

[0004] One problem with typical inhaler devices is that the user may not know when they need to be replaced or refilled. It is important for users of inhalation devices to maintain a regular medication regime. Many existing inhaler devices are difficult to use unless the user is on a different reminder schedule. Furthermore, it is often useful for medical professionals associated with a user to know details about how and when that user utilizes an inhalation device in order to improve future treatment. Such information is difficult or impossible to obtain using typical inhaler devices unless the user keeps track of their own use.

[0005] Smart inhaler devices have continually offered the ability to monitor inhaled doses. However, these smart inhaler devices still experience poor user uptake. Some users may acknowledge that there is a social stigma associated with using inhalation systems and may therefore be reluctant to use such inhalation devices as recommended by medical professionals. Additionally, many such inhaler devices suffer from poor ergonomics and incorrect use.

[0006] The present invention aims to provide an improved inhalation device and inhalation system that alleviates the above problems. Summary of the Invention

[0007] According to a first aspect of the present invention there is provided an inhalation device operable to deliver a dose of an active ingredient. The inhalation device comprises: a housing having a mouthpiece; a removable flow regulator supported at least in part within said housing, said flow regulator having a "cavity" operable to receive a vessel containing an active ingredient; an electronic component operable to monitor and transmit inhalation data to a remote device; It is equipped with:

[0008] Such an inhalation device is conveniently reusable and can be used as part of an inhalation system as described below.

[0009] The "flow regulator" may be a filter. Depending on the type of inhalation device, the "vessel" may comprise a cartridge, reservoir, canister, blister, or the like.

[0010] The electronic component is mounted within the removable filter such that the removable filter and the electronic component together comprise a "removable core." This "detachable core" allows the inhaler device to be easily removed and cleaned.

[0011] The electronic component includes a power source such as a battery, a solar cell, or a kinetic charger. This eliminates the need to connect to an external power source to operate the inhaler. However, the inhaler may also be connected to an external power source or a rechargeable battery via a wired or wireless connection.

[0012] Additionally, the inhaler device includes a "cap" that covers the mouthpiece of the inhaler device. The cap secures the filter and housing by utilizing an "electromagnetic closure." If desired, the electronic components may be contained within the cap of the inhaler, or may be partly within the inhaler and partly within the cap. The cap keeps the inhaler clean, and the electromagnetic closure allows the cap to be easily removed and replaced.

[0013] The inhalation data may include one or more of: "usage data", "location data", and "dosage data".

[0014] The inhaler may include a "dose counter" that counts or determines dosage data, such as the number of doses delivered by the inhaler. The electronic component may send an alert about the number of doses delivered, for example, when the number of doses administered exceeds a predetermined threshold, or when the number of doses administered does not match a minimum threshold.

[0015] The inhaler may include a "location sensor," such as a GPS receiver, that operates to determine "location data," such as the current location of the inhaler.

[0016] The inhalation device may include one or more sensors operable to determine "usage data." Such sensors may include, but are not limited to, one or more of a microphone, an image sensor, an airflow meter, an accelerometer, and a magnetometer.

[0017] Additionally, the inhalation device includes an "indicator component." The indicator component may be an indicator ring connectable between the housing and a "detachable filter."

[0018] The removable filter is configured to regulate the flow rate of fluid through the inhalation device. For example, areas of the surface may be configured to regulate fluid flow. In one example, the removable filter has one or more "channels" or operable "openings" to regulate the flow rate of fluid through the inhalation device.

[0019] The housing may have a "body portion" having a first longitudinal axis and a "mouthpiece portion" having a second longitudinal axis oriented at an angle to the first longitudinal axis. Here, the angle is preferably within a range of 125° to 140° (for example, 130° to 135°), and most preferably 133°. The angle of the housing may be selected to mirror or conform to geometries in existing medical inhalation devices.

[0020] The housing may have a translucent portion or may be translucent. The housing may also be opaque, for example metallic.

[0021] The outer surface of the filter may abut the "inner wall" of the housing. When a vessel, such as a "canister," is inserted into the filter cavity, the filter may fill the space between the vessel and the interior wall of the housing.

[0022] According to a second aspect of the present invention, there is provided a "cap" for covering the mouthpiece of an inhalation device. The cap includes electronic components operable to monitor and transmit inhalation data to a remote device. Inhalation data includes one or more of the following: "patient data", "usage data", "location data", and "dosage data".

[0023] The cap may be provided in combination with an inhalation device operable to deliver a dose of the inhalable active ingredient. The inhalation device comprises a housing having a mouthpiece and a removable "flow regulator" supported at least partially within the housing. The flow regulator consists of a "cavity" that is operable to receive a vessel containing the active ingredient. In particular, a cap may be provided in combination with or adapted for use with an inhalation device according to the first aspect of the invention. Alternatively, the cap may be provided as a "stand alone" device that can be fitted to existing inhaler devices.

[0024] The "inhalation system" provided by the third aspect of the present invention comprises: an inhaler according to the first aspect of the invention and / or a cap according to the second aspect of the invention; a computer program application that, when running on a client device, causes the client device to receive inhalation data from the electronic component; It is equipped with:

[0025] Additionally, the computer program application may be operable to receive supplemental data from data sources other than the electronic component. Here, the supplemental data includes one or more of user data, sensor data, and environmental data.

[0026] Additionally, the computer program application may be operable to transmit received inhalation data and supplemental data to a "remote server" on a network. The transmitted data is stored in a cloud-based storage system and is accessed by a user from a client device or other device that can communicate over a network.

[0027] Additionally, the computer program application may operate to store the received inhalation data and supplemental data in memory on the client device.

[0028] The inhalation data may include location data indicating the physical location of the inhalation device and / or cap. Additionally, the computer program application may be operable to display the current location of the inhalation device on the user's client device. The inhalation data may include "usage data" indicating the number of doses administered using the inhalation device or the number of doses not administered using the inhalation device, and the computer program application may further display the usage data to a user of the client device. The inhalation data may include "dosage data" indicating the number of doses taken using the inhalation device, and the computer program application may display the dosage data to the user of the client device.

[0029] A computer program application communicates with the network, and the computer program application may use the network to perform operations to search for and retrieve environmental data.

[0030] The computer program application communicates with a network, and the computer program application may be operable to receive anonymized intake data and anonymized supplemental data from other users of the system.

[0031] According to the third aspect of the invention, selected features from the specification as well as features from the first and second aspects of the invention may be combined in any order. [Brief explanation of the drawings]

[0032] Embodiments of the invention will now be described, by way of example, with reference to the drawings in which: [Figure 1] 1 is a schematic diagram of an inhalation device in an inhalation system. [Figure 2] FIG. [Figure 3] FIG. 3 is a front view of the inhaler of FIG. 2. [Figure 4] FIG. 3 is a plan view of the inhaler of FIG. 2. [Figure 5]3 is an exploded side view of the inhaler of FIG. 2, showing the internal structure in the dashed line portion. [Figure 6] FIG. 3 is a cross-sectional view of the inhaler of FIG. 2. [Figure 7] FIG. 3 is an exploded perspective view of the inhaler of FIG. 2. [Figure 8] FIG. 3 is an exploded front view of the inhaler of FIG. 2. [Figure 9] FIG. 3 is a schematic diagram of airflow through the inhaler of FIG. 2. DETAILED DESCRIPTION OF THE INVENTION

[0033] Referring to FIG. 1, an inhalation system is illustrated, in this case a metered dose inhaler system. The system includes an inhaler 12 and a computer program application 14 that is installed and operated on a client 16 remote from the inhaler. In the example shown in FIG. 1, the client device 16 is a mobile phone and belongs to the user of the inhaler device 12 .

[0034] Inhaler 12 in FIG. 1 is a metered dose inhaler, although it could alternatively be other types of inhalers such as a dry powder inhaler or a soft mist inhaler. Inhaler device 12 is a smart inhaler device that includes an electronic component 18 that monitors inhalation data and transmits the inhalation data to a remote device (e.g., client device 16), as indicated by arrow 20 in FIG.

[0035] The computer program application 14 is operable while running on the client device 16 to cause the client device 16 to receive inhalation data from the electronic component 18 . Additionally, computer program application 14 operates to cause client device 16 to receive supplementary data from data sources other than electronic component 18 as indicated by arrow 22 . Such data sources are remote computers or servers 24 with which the computer program application 14 communicates over a network 26 such as the Internet. Alternatively, or additionally, the data source may be another component of the client device (such as the client device's internal memory 28 or sensors on or available to the client device, such as an accelerometer or heart rate monitor).

[0036] Additionally, the computer program application 14 is operable to transmit the received inhalation data and supplemental data to a remote server 30 . Such communication may occur over network 26, as indicated by arrow 32, or via a direct wired or wireless connection, as indicated by arrow . The transmitted data is securely stored on a highly secure cloud platform for access by authorized device users and healthcare professionals. Alternatively, or additionally, the computer program application may be operable to store the received inhalation data and supplemental data in memory 28 of the client device.

[0037] The core purpose of the system 10 shown in Figure 1 is to help patients, carers, general practice, government agencies and the pharmaceutical industry improve the quality of life for users of inhalation devices, such as those with asthma, chronic obstructive pulmonary disease (COPD), and those who require other inhaled medications or solutions.

[0038] As described above, the system 10 operates to record "inhalation data" such as "usage data," "location data," and "dosage data," along with "supplemental data" such as patient information and environmental factors to aid in disease management. This data may be provided to the user (e.g., displayed to the user on a client device via computer program application 14) to enable the user to better understand triggers associated with the user's condition. The data may also be provided to medical professionals associated with the user to assist them in improving the treatment options available to the user. Additionally, collected data (preferably anonymized) may be communicated to government agencies and industry entities. Such notifications may be made, for example, to assist in planning and management for those affected by a situation, to gain better insight into hotspots (such as locations and durations of poor air quality or high pollen counts), or to better understand user behavior. If necessary, all collected data may be stored on a cloud platform so that any entity with appropriate permissions can access the collected data.

[0039] "Usage data" may include, for example, but is not limited to, inhalation rate, inhalation sound, one or more images of the user's throat or oral cavity, and dispense time. To achieve this, the inhalation device may be equipped with an airflow meter that records one or more of the following: maximum inhalation velocity, maximum exhalation velocity, average velocity, and duration. Alternatively, or additionally, to assist in measuring respiratory function, the inhalation device may include a microphone to record or monitor sounds made when the user inhales or exhales. Alternatively, or additionally, the inhaler device may include a camera or other image sensor (such as the Sonicare® FlexCare Platinum) for capturing images of the user's mouth and throat area.

[0040] "Location data" may include, for example, but is not limited to, the location where administration is to occur, the current location of the inhaler, and the last known location of the inhaler. To achieve this, the inhalation device (eg, electronic components) may be equipped with a location sensor, such as a GPS sensor.

[0041] "Dose data" may include, for example, but is not limited to, the number of doses administered by the inhaler device and the number of doses held within the inhaler device. To achieve this, the inhaler device may be equipped with a dose counter.

[0042] As noted above, a primary goal of the present system 10 is to improve disease management through smart technology and personalized applications that record inhaler dosage, location, environmental, and other data to inform patients (and other stakeholders) and enable treatment review.

[0043] However, a secondary purpose of the present system 10 is to promote user compliance with the healthcare system. Many common inhalation devices are disposable, and therefore they are often made from low-cost materials and are unattractive or difficult to use correctly. To improve the experience of such users, the applicant has found it desirable to improve the perceived quality and value of inhalation devices. This encourages users to keep the inhaler nearby at all times. Furthermore, it would be desirable to make inhalation devices more attractive, comfortable and efficient to use.

[0044] Designing an inhaler device that has a longer lifespan than disposable inhalers presents many challenges. Reusable devices must be easily cleanable and ergonomically equipped with the smart electronic components needed to track inhaler dosage and use. Such a reusable inhalation device 12 is shown in FIGS. Although Figures 2-9 show metered dose inhalers, it will be understood that the principles discussed below are equally applicable to other types of inhalers, such as dry powder inhalers and soft mist inhalers.

[0045] 2, 3 and 4 respectively show side, front and plan views of a metered dose inhaler device 12 that delivers a metered dose of aerosolized active ingredient, often a liquid. 5, 7 and 8 show an exploded side view, an exploded perspective view and an exploded front view, respectively, of metered dose inhaler 12, while FIG. 6 shows a cross-sectional view of metered dose inhaler 12. FIG. The metered dose inhaler 12 includes a housing 36 with a mouthpiece 38 having an opening through which a user of the metered dose inhaler inhales the aerosolized active ingredient during use of the device.

[0046] In this example, the mouthpiece 38 is integral with the housing 36 . Thus, the housing 36 has a “body portion” 40 and a “mouthpiece portion” 42 . Each of these sections has a longitudinal axis. A longitudinal axis 44 of mouthpiece portion 42 is at an angle 46 relative to a longitudinal axis 48 of body portion 40 . In this example, the angle 46 is approximately 133°, but the angle may be in the range of 125° to 140°, for example in the range of 130° to 135°. This angle range is centered around 133° and has been selected to provide more clearance for the user's nose than typical disposable inhaler devices, and to allow the inhaler to be gripped comfortably when in use. However, it will be appreciated that the angles may alternatively be selected to reflect or conform to the geometry of existing inhalation devices. Both the body portion 40 and the mouthpiece portion 42 are cylindrical in shape to provide a compact configuration for the inhaler device. However, if desired, the inhaler device can have other cross sections and shapes.

[0047] The mouthpiece may have an opening that is wider than the opening of a typical inhaler device. The opening of a typical inhalation device has a circular periphery. In contrast, the inhalers shown in Figures 2 to 9 have an opening with flat edges at the top and bottom so that it has a roughly oval shape. As a result, the mouthpiece takes on a more organic shape and feels more natural in use. In this example, the mouthpiece opening has a maximum width along the horizontal axis of approximately 22 mm and a radius of approximately 9 mm, while the maximum width along the vertical axis (perpendicular to the horizontal) is smaller than the horizontal axis, for example 90%, 85%, or 80% of the horizontal axis (in this example, approximately 18 mm).

[0048] The cross section of the mouthpiece varies along its length. For example, the mouthpiece may taper towards the opening. In the example shown, the mouthpiece has a circular cross section where it abuts the housing (which has a diameter of about 26 mm). The cross section of the mouthpiece is tapered and flattened towards the mouthpiece opening. Of course, if desired, a standard circular cross section may be used instead.

[0049] Additionally, the inhalation device 12 includes a removable flow regulator 50 (also referred to herein as a "detachable filter"). A removable flow regulator 50 is supported at least in part within the housing 36 . The removable flow regulator 50 has a cavity 52 operable to receive a vessel containing the medication to be delivered. The inhaler shown in Figures 2 to 9 is a metered dose inhaler, so in this example the container is a canister 54 containing an aerosolized active ingredient. "Detachable" in this context means that the inhaler device can be disassembled by removing the flow regulator and reassembled by replacing it with the same flow regulator (or another similar flow regulator).

[0050] In the illustrated example, the housing has an inner wall 58 that defines an interior space 60 . The outer surface 62 of the flow regulator 50 has a shape that complements the inner wall, so that when the flow regulator 50 is inserted into the interior space 60 of the housing 36, the outer surface 62 of the flow regulator abuts the inner wall 58 of the housing. This ensures that when the canister 54 is inserted into the cavity 52 in the flow regulator 50, there is very little free space between the canister 54 and the inner wall 58 of the housing. Like the body portion of the housing, the flow regulator 50 is cylindrical. However, the flow regulator may have other shapes if necessary to make use of the internal space within the inhaler device.

[0051] Typical inhalation devices have a large gap between the medication containing container (eg, an aerosol canister) and the housing to allow dirt and dust to collect in the space adjacent to the canister. This debris can be inhaled by the user when using the inhaler, creating a potential hazard that can cause anxiety and loss of confidence in the inhaler. The detachable flow regulator 50 prevents the buildup of such deposits and filters the inhaled air, removing particles such as those picked up from a pocket or bag (hence the flow regulator is also referred to herein as a "detachable filter"). This is because the filter 50 is removable and can be easily cleaned to remove filtered particles.

[0052] The flow regulator 50 / filter 50 may regulate the rate at which airflow is drawn through the inhaler device when in use. In this example, the flow regulator comprises a plurality of ribs 51 with "air flow channels 53" between adjacent ribs 51. Each rib is curved in an elongated S-shape. The channel 53 has a U-shaped cross section. The filter regulates airflow through the inhaler by restricting the space between the ribs to control the velocity of air drawn through the filter. The rib configuration increases the path length of airflow through the filter. Adjusting the airflow in this manner encourages the user to extend the length of their inhaler, allowing time for accurate delivery of the medication to the lungs. The U-shaped cross-section of the channel ensures that the filter can be easily cleaned when removed from the housing.

[0053] Other designs of filters are possible that accomplish the function of regulating airflow through the inhalation device. For example, the airflow channels may have other path shapes than those shown, and may be tailored to, for example, limit the velocity of air flowing through the inhalation device. Likewise, the channels may have different cross sections. Alternatively, or additionally, air flow may be controlled by constrictions or openings of a size selected to adjust the limit or flow rate. Airflow may be controlled by careful design of the outer surface of the filter, for example by providing golf ball dimples. The airflow can be controlled jointly or independently by the shape and size of the mouthpiece opening and the internal arrangement of the actuator body. Additionally, the flow regulation features (eg, channels, dimples, etc.) may be located on the housing rather than on the flow regulator, or part of the flow regulation features may be located on the housing and part on the flow regulator.

[0054] As mentioned above, the inhalation device 12 includes an electronic component 18 that operates to monitor and transmit inhalation data to a remote client device. In this example, the electronic component 18 is disposed within the removable filter 50 such that the removable filter 50 and the electronic component 18 collectively form a "removable core 56." The removable core 56 is removed from the inhaler device to disassemble the device, and then replaced to reassemble the device. Such an electronic component with a detachable core 56 allows for efficient cleaning of not only the filter 50 but also the housing 36 (including the mouthpiece). Additionally, the electronic component with the detachable core 56 allows for easy assembly and maintenance of the electronic component 18 . For example, electronic components are stored within the filter 50 using removable fasteners 63, such as screws. However, if desired, the electronic components can be separated from the removable filter and located in a different location on the inhaler device. For example, the electronic components may be provided within the cap. The electronic device may be located between two (or more) electronic components located in different parts of the inhaler device (eg, an electronic component in the filter and an electronic component in the cap). Wherever the electronic components are located, they are contained within a waterproof or watertight enclosure.

[0055] In the illustrated example, to accommodate the electronic component 18, the filter 50 has an "extended portion 50a" below the filter portion that accommodates the canister. To this end, filter 50 has a chamfered cylindrical shape so that the filter fits snugly within body portion 40 of housing 36 . The electronic components are located below the canister and may be housed within an extension of the filter. The cavity 52 holding the canister 54 may, for example, extend into an extended portion 50 a so that both the canister 54 and the electronic component are housed within one and the same cavity 52 .

[0056] The electronic components 18 may have a power source (not shown) and may be self-powered so that the inhaler does not need to be connected to an external power source or charger. The power source may be a kinetic charger. Such chargers convert kinetic energy into electrical power and are required to emulsify the propellant in the aerosol canister, encouraging the user to shake the inhaler device before use. Alternatively, a power source such as a battery or solar cell may be used if preferred. The battery may be rechargeable and may be charged by an external power source.

[0057] The electronic component 18 may operate to collect inhalation data. Such data may include, for example, "usage data" indicating when the inhaler device was activated to deliver a dose of active ingredient. Such data may also include dosage data indicating the number of doses administered by the inhaler device. Such data may also include "location data" indicating the location of the inhaler using, for example, GPS coordinates.

[0058] To aid in the collection of inhalation data, the electronic component may include an internal processor with a timing clock. The processor communicates with a dose counter 64 , such as a pressure or piezoelectric switch, and a GPS receiver 66 .

[0059] If necessary, one or more "usage sensors" (not shown) such as a microphone, image sensor, airflow sensor, particle sensor, gyroscope, accelerometer, or magnetometer may be incorporated into the inhalation device. These sensors may be in communication with a processor and may be operable to collect data (e.g., audio data as the user inhales or exhales, one or more internal images of the user's throat or mouth, and data regarding inhalation rate) and send that data to the processor. One or more usage sensors that record usage data are used to listen to and calculate flow rate and length of inhalation. The recorded peak inspiratory flow rate (PIFR) or peak flow rate is used as a baseline. The microphone will also be used to listen to lung function and lung health.

[0060] The electronic component may also include a transmitter-receiver 68, such as a Bluetooth® transmitter-receiver or transceiver, for transmitting the collected inhalation data to an application 14 installed on the client device 16.

[0061] Additionally, the inhalation device 12 shown in Figures 2-9 includes an "indicator component 70." In this example, the indicator component 70 is in the form of a ring that can be connected between the housing 36 and the filter 50, for example by snap-fitting or threading to frictionally engage both the housing and the filter. Such an indicator component 70 is used to provide an indication of the medication contained within the canister 54 . For example, the name of the medication may be written on the display component 70 . The display component may be color-coded to provide a remote indication of the medication contained within the inhaler device, and may also include a Braille medication display for the visually impaired. The indicator component helps prevent confusion when a user owns multiple inhaler devices. In the illustrated example, the user must have access to the indicator component because the inhalation device cannot be properly assembled without it (because without it the filter cannot be safely seated in the housing). However, other configurations of the inhaler device may omit the indicator component if not required.

[0062] The inhalation device 12 of this example, and in particular the cavity 52 within the filter 50, is configured to accommodate common commercially available medication dispensing canisters. Such canisters typically have an internal metering valve and actuator, and when the actuator is activated (usually pressure-activated), a fixed dose of the active ingredient within the canister is aerosolized.

[0063] To use the inhalation device 12, the user first shakes the inhalation device to emulsify the propellant in the canister. This advantageously also dynamically charges the electronic components. The user must then depress the canister 54 to activate the canister actuator 72 . This will deliver a fixed dose of the active ingredient in the canister. This action advantageously also activates the dose counter 64 .

[0064] In other examples, the cavity 52 in the flow regulator 50 / filter 50 may be configured to receive other types of containers, and may receive commercially available drug containers such as dry powder blisters, blister packs, reservoirs, or soft mist cartridges. The outer dimensions of such removable filters may be the same to provide a standard size for use with a variety of different filter types within the same inhaler housing (e.g., the shape of the outer surface 62 may complement the shape of the inner wall 58 of the housing 36 such that the outer surface 62 of the flow regulator abuts the inner wall 58 of the housing when the filter 50 is inserted into the interior space 60 of the housing).

[0065] Additionally, the inhaler 12 includes a cap 74 that protects the mouthpiece when the inhaler is not in use. The cap has a closure, such as the electromagnetic closure shown in this example. A first portion 76a of the electromagnetic closure is provided within the housing 36 (eg, within the detachable core 56) when the inhaler is assembled. A second portion 76b of the electromagnetic closure is provided within cap 74 (eg, below upper cap 78). The inclusion of cap 74 with electromagnetic clasp 76 allows for quick removal in an emergency and provides comfort and satisfaction during normal use. For further minimization, it can be configured without a typical cap. The cap may contain all or part of the electronic components. For example, the cap may be hung from the inhaler device so that it remains attached to the inhaler device even when the cap is removed. The pressure or touch sensitive dose counter may be a strap that connects the inhaler to the cap. For example, such a strap may be placed around the base of the inhaler device where the user's thumb or fingers rest. As described above, the dosage sensor communicates with electronic components within the cap that send data (eg, dosage data) to the client device.

[0066] In configurations with an electromagnetic closure, the electromagnetic closure provides a data and power connection between the cap and electronic components in the inhaler body (eg, filter). For example, the cap may have a charging connector and the electromagnetic closure may transfer power from the cap to a battery located within the filter to charge the battery within the filter. Inhalation data collected by the filter is transmitted via a data link within the electromagnetic closure to the cap (and subsequently to the client device) and vice versa.

[0067] The inhaler device may have an "inhalation rate indicator" that indicates to the user that they are inhaling at a suitable rate (eg, fast enough). Such an inhalation rate indicator may be "mechanical" (e.g., a moving element that indicates flow proportional to the distance displaced); "digital" (e.g., signaled by an airflow sensor as described above); or "acoustic" (e.g., producing a sound when a velocity threshold is reached or exceeded, e.g., the sound is generated due to a filter shape, such as the shape of the airflow channel).

[0068] Similarly, the inhalation device may include a start-up or activation indicator to assure the user that the dose of medication is working properly. For example, there may be a mechanical, physical, digital or audible indication when the canister is properly depressed to deliver a dose.

[0069] The inhalation device may have one or more light sources, such as, for example, one or more LEDs. The light source assists in indicating the location of the inhalation device (eg, the electronic component operates the light source in response to instructions from an application on the client device). Additionally, the light source illuminates to provide the user with information regarding use, dosage, inhalation technique, battery, etc.

[0070] The inhalation device may include luminescent material, for example luminescent paint. This helps indicate the location of the inhaler, is particularly convenient for patients with visual impairments, and can also draw the attention of children to the inhaler.

[0071] When not in communication with the inhalation system 10, the inhalation device 12 operates like a typical (non-smart) inhalation device. To use the inhalation device 12 within the inhalation system 10, a user first downloads the inhalation device computer program application 14 onto a client device 6, such as a mobile phone, tablet, or personal computer. The user then pairs the inhaler device 12 with the application 14 installed on the client device. This pairing may use an existing handshake pairing method such as Bluetooth® compliant. In particular, the client device may send a connection request to an electronic component of the inhaler that accepts the connection request and sends a response (or vice versa). Once pairing is established, the user may desynchronize the inhaler from their client device. This ensures the security of the inhaler device in case of loss of traceability.

[0072] Once pairing is established, the electronic component 18 of the inhalation device 12 is able to send inhalation data to and receive data from the client device 16 . Such data may be sent at regular time intervals or after usage events. The data may be transmitted only when the inhalation device 12 is within communication range of the client device 16, for example, in response to a request from the client device. Thus, the electronic component may have internal memory for storing the inhalation data until it can be transmitted. The received inhalation data is stored in one or more records in the memory of the client device.

[0073] The computer program application 14 retrieves supplemental data such as environmental data including data related to air quality (eg, air quality index), weather, pollen counts, and other environmental factors germane to the deterioration of the patient's condition. The environmental data is stored in the memory of the client device in association with the stored inhalation data. For example, data associated with a particular use event (eg, sensor data, time, dosage measurements, location) may be stored in a record along with data associated with environmental conditions at the time of the use event.

[0074] The application may take action to alert the user when environmental conditions worsen the user's condition (e.g., when air quality drops below a threshold or pollen counts rise above a threshold). In this way, the user is reminded to carry the inhaler device with them.

[0075] The application may communicate with external services such as e-prescriptions, doctor consultations (user's registered doctor), hospitals (nearest emergency department), and ambulance services. From the usage data it receives, the application can determine if the patient is experiencing severe breathing difficulties (for example, a severe asthma attack). This functionality is achieved by using AI and machine learning to compare incoming usage data with historical usage data (either from the patient themselves or collected from other patients). If it determines that a serious attack is occurring, the application will prompt the user to call emergency services or will automatically call emergency services. Data collected by the application, such as inhalation and environmental data, is provided to emergency services. In this way, emergency physicians are aided in locating the patient and diagnosing the patient's condition.

[0076] The application alerts the patient when the number of doses administered by the inhaler device rises above a threshold value. This provides an incentive for the user to replace the medication dispensing canister. Similarly, the application will also alert the user when the number of doses administered by the inhaler device does not meet a minimum threshold. This provides an incentive for the user to use the inhaler device.

[0077] The application requests inhalation data from the electronic component when instructed by the user. For example, a user may request location data from an inhaler from an application, which then displays the requested location information on a map to the user so that the user can locate their inhaler. Similarly, the user may instruct the application to request usage information from the inhalation device. The application then displays to the user information obtained from the inhaler device sensors, such as inhalation rate, to help the user improve their inhalation technique.

[0078] The application may also be user configurable to provide alerts or notifications when it detects that the client device has been moved, or when the inhaler device is not nearby or present. In this way, the user is reminded to carry the inhaler device with them.

[0079] Additionally, users may input personal data into the application, such as their own condition. The application may also obtain other user data via the client device, such as data related to the user's activity, such as step count and heart rate.

[0080] The application may include software that presents a treatment regime to the user. Gamification encourages users to comply with a treatment regime (eg, rewards may be given for compliance). Additionally, the application may use sensor data recorded from the inhalation device to provide guidance in lung function training and to measure and improve the user's lung function.

[0081] If desired, all data received by the computer program application may be transmitted to a remote server, such as a computer associated with a medical professional or research institution. Alternatively, or additionally, such data may be securely stored on a highly secure cloud platform for access by users and other entities from other internet-enabled computing devices.

[0082] The inhalation system 10 described in this example provides a data log that correlates closely to three core pieces of data. (A) Personal information: treatment, number of dose measurements, heart rate, etc. (B) Information about the patient's environment: current location, planned outings, weather, pollen count, pollution (C) Health, treatment and medication information

[0083] Such data allows individuals to better understand their health status and triggers. Such data also allows medical professionals to improve the treatment of patients' illnesses, such as by allowing them to easily review their treatment. The system allows medical professionals to make treatment changes and recommendations to patients via the application.

[0084] User data from multiple users is collected and anonymized by the system to assist researchers and medical professionals in understanding the effectiveness of treatment regimes. Such usage analysis helps to share experiences across a cross-section of user populations. For example, anonymized usage data may be provided to a client device for access by a user of the client device. "Dull" usage data may be provided along with location data to allow co-located users to benefit from information about other users on the system. Similarly, desensitized data may be provided along with anonymized user data such as details of user activities such as exercise and details of the user's health. This allows users with a particular health condition to understand what activities (such as types of exercise) have affected other users with the same or similar health condition.

[0085] Data collected by the inhalation device and from complementary data sources can be used to construct data models for attack prediction and disease insights. This functionality is enabled by scientific data tools such as artificial intelligence and machine learning. This data will be collected anonymized for use in patient-disease comparisons in research, deep learning and modeling, and to monitor health metrics such as BPM and SpO2 levels before, during and after illness, as well as analyzing various data such as the ambient AQI (Air Quality Index).

[0086] The inhalation devices described herein have a long lifespan as they are easily removable for efficient cleaning. If desired, the components of the inhaler device may be selected so that the components of the inhaler device are fully recyclable. The inhalation device may be fabricated using a material palette aligned with premium personal devices and accessories such as smartphones and car phones to potentially change patients' perceptions of inhalation devices. For example, if an inhaler device is perceived as an important personal accessory, it will be carried more frequently and users will be less likely to refrain from using it in public. Personalization can be achieved through color and material selection or imagery. Examples of materials used for the housing include metal (e.g., aluminum), resin, plastic, PCR plastic or bioplastic, and acetate. The housing may have user selectable colors and user customizable printing. The filter may be made of aluminum or other materials as described for the housing. Of course, if desired, the inhaler device may be made from other materials, including lower grade materials such as those used in existing inhaler devices.

Claims

1. 1. An inhalation device operable to deliver a dose of an inhalable active ingredient, comprising: a housing having a mouthpiece; a removable flow regulator supported at least in part within the housing, the flow regulator having a cavity operable to receive a container containing an active ingredient; an electronic component operable to monitor inhalation data, including one or more of usage data, location data, and dosage data, and to transmit the inhalation data to a remote device; Equipped with The flow regulator When a container is inserted into the cavity of the flow regulator, an outer surface of the flow regulator abuts against an inner wall of the housing to fill a space between the container and the inner wall of the housing; a plurality of ribs for increasing the path length of airflow, with airflow channels between adjacent ribs, thereby regulating the velocity of airflow drawn through the inhaler and also functioning as a removable filter for filtering the inhaled air by removing particles picked up from a pocket or bag; In addition, the flow regulator has a structure for adjusting the flow rate of fluid passing through the inhalation device, the structure having one or more channels, dimples, or openings; The electronic component is disposed within the flow regulator, such that the electronic component and the flow regulator together form a removable core that can be removed from the inhaler to disassemble the inhaler and replaced to reassemble the inhaler. An inhalation device characterized by being configured as follows.

2. 2. The inhalation device of claim 1, The electronic component is disposed with the detachable flow regulator such that the detachable flow regulator and the electronic component collectively form a detachable core. An inhalation device characterized by being configured as follows.

3. 3. The inhaler according to claim 1 or 2, The electronic component is power supply, Equipped with An inhalation device characterized by being configured as follows.

4. 4. The inhalation device according to claim 3, Electromagnetic closures, Equipped with The first portion 76a of the electromagnetic closure is provided within the housing 36 when the inhaler is assembled; A second portion 76b of the electromagnetic closure is provided within a cap 74 that covers the mouthpiece; The cap 74 has an electromagnetic closure for quick removal in an emergency and for comfort and satisfaction during normal use. An inhalation device characterized by being configured as follows.

5. 4. The inhalation device according to claim 3, a dose counter that counts the number of doses administered by the inhaler; Equipped with An inhalation device characterized by being configured as follows.

6. 6. The inhalation device according to claim 5, The electronic component sends an alert when the number of administered doses exceeds a predetermined threshold or when the number of administered doses does not match a predetermined number. An inhalation device characterized by being configured as follows.

7. 4. The inhalation device according to claim 3, indicator component, Furthermore, The indicator component is an indicator ring connectable between the housing and the removable flow regulator. An inhalation device characterized by being configured as follows.

8. 4. The inhalation device according to claim 3, The housing includes: a body portion having a first longitudinal axis; a mouthpiece portion having a second longitudinal axis oriented at an angle relative to the first longitudinal axis; It has The angle is in the range of 130° to 135°. An inhalation device characterized by being configured as follows.

9. 4. The inhalation device according to claim 3, (i) the housing has a translucent portion or is translucent; and / or (ii) The housing is made of metal or opaque colored parts. An inhalation device characterized by being configured as follows.

10. 4. The inhalation device according to claim 3, The inhaler is a metered dose inhaler, a dry powder inhaler, a breath-actuated inhaler, or a soft mist inhaler. An inhalation device characterized by being configured as follows.

11. 4. The inhalation device according to claim 3, The electronic components are housed in water-resistant or waterproof components. An inhalation device characterized by being configured as follows.

12. 1. An inhalation system comprising: An inhalation device according to any one of claims 1 to 11; a computer program application that, when running on a client device, causes the client device to receive inhalation data from an electronic component; Equipped with An inhalation system characterized by being configured as follows.

13. 13. An inhalation system according to claim 12, The computer program application receiving supplemental data from a data source other than said electronic component; The supplemental data includes at least one of user data, sensor data, and environmental data. An inhalation system characterized by being configured as follows.

14. 14. An inhalation system according to claim 12 or 13, The computer program application Sends received inhalation data and supplemental data to a remote server on the network An inhalation system characterized by being configured as follows.

15. 15. An inhalation system according to claim 14, The computer program application Storing the received inhalation data and supplemental data in memory of the client device. An inhalation system characterized by being configured as follows.

16. 15. An inhalation system according to claim 14, (i) the inhalation data includes location data indicating a physical location of the inhalation device, and the computer program application displays the current location of the inhalation device on a user's client device; and / or (ii) the inhalation data includes a number of doses administered using the inhalation device and usage data indicating that no doses have been administered using the inhalation device; the computer program application displays the usage data to a user of the client device; and / or (iii) the inhalation data includes dosage data indicating the number of doses administered using the inhalation device; The computer program application displays the dosage data to a user of a client device. An inhalation system characterized by being configured as follows.

17. 15. An inhalation system according to claim 14, The computer program application Communicate with the network, Use the network to search for and retrieve environmental data An inhalation system characterized by being configured as follows.

18. 15. An inhalation system according to claim 14, The computer program application Communicate with the network, Receive anonymized inhalation data and anonymized supplemental data from other users of the inhalation system. An inhalation system characterized by being configured as follows.

Images