GB2552539A

GB2552539A - System and method for use with an inhaler, nebuliser or other such similar device

Info

Publication number: GB2552539A
Application number: GB1613074.2A
Authority: GB
Inventors: Rudin John; Kitson Stephen; Simon Taphouse Timothy; webb Alexander
Original assignee: Folium Optics Ltd
Current assignee: Folium Optics Ltd
Priority date: 2016-07-28
Filing date: 2016-07-28
Publication date: 2018-01-31
Also published as: GB201613074D0

Abstract

A system 100 for use with inhalers or nebulizers, the system comprising at least one inhaler apparatus 101 configured to attach to an inhaler and adapted to detect operation or actuation thereof. A user-wearable or mountable apparatus 103 configured to receive data from the/each inhaler apparatus 101 is also provided as a part of the system 100. The inhaler apparatus 101 is preferably configured to attach to the top of the inhaler, the mouthpiece, the mouthpiece cover or the actuating mechanism thereof. The wearable device 103 is further preferably able to transmit the data received from the inhaler apparatus 101 to a server 111, such that the information may be remotely accessed by a carer 113, clinician 115 or otherwise interested party. The user-wearable apparatus 103 may further comprise a processor configured to discriminate between multiple inhaler apparatuses 101 such that is may track the use of individual ones of multiple inhaler apparatuses 101.

Description

(71) Applicant(s):

Folium Optics Ltd

Unit 28,Cooper Road, Thornbury, Bristol, BS35 3UP, United Kingdom (72) Inventor(s):

John Rudin

Stephen Kitson Timothy Simon Taphouse Alexander Webb (56) Documents Cited:

WO 2016/049066 A1 WO 2015/174856 A1

WO 2014/184293 A1 WO 2001/026021 A1

US 20150335834 A1 US 20110225008 A1 (58) Field of Search:

INT CLA61M

Other: WPI, EPODOC, TXTA (74) Agent and/or Address for Service:

Bryers LLP

Gay Street, BATH, BA1 2PH, United Kingdom (54) Title of the Invention: System and method for use with an inhaler, nebuliser or other such similar device Abstract Title: Apparatus for transmitting information regarding the operation of an inhaler to a userwearable apparatus (57) A system 100 for use with inhalers or nebulizers, the system comprising at least one inhaler apparatus 101 configured to attach to an inhaler and adapted to detect operation or actuation thereof. A user-wearable or mountable apparatus 103 configured to receive data from the/each inhaler apparatus 101 is also provided as a part of the system 100. The inhaler apparatus 101 is preferably configured to attach to the top of the inhaler, the mouthpiece, the mouthpiece cover or the actuating mechanism thereof. The wearable device 103 is further preferably able to transmit the data received from the inhaler apparatus 101 to a server 111, such that the information may be remotely accessed by a carer 113, clinician 115 or otherwise interested party. The userwearable apparatus 103 may further comprise a processor configured to discriminate between multiple inhaler apparatuses 101 such that is may track the use of individual ones of multiple inhaler apparatuses 101.

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SYSTEM AND METHOD FOR USE WITH AN INHALER, NEBULISER OR OTHER SUCH SIMILAR DEVICE

TECHNICAL FIELD

Aspects relate, in general, to a system and method for use with an inhaler, nebuliser or other such similar device.

BACKGROUND

Inhalers are medical devices typically used on either a regular basis (also known as a ‘preventer’) or on an occasional basis (also known as a ‘reliever’). They are generally metered dose devices that are used to deliver medication via the lungs, but they may also include devices that are designed for nasal use in order to deliver a decongestant for example, and devices that provide an unmetered dose.

For conditions, such as asthma for example, there is evidence that regular use of the preventer is important in avoiding incidents leading to costly hospitalisation, and that excessive use of a reliever is an early indication of more serious problems, which can result in death. Management and correct use of inhalers, which can be uncontrolled (particularly with children and adolescents) is therefore an important issue.

Systems exist which incorporate dose and actuation tracking as part of the inhalation device, either as part of the drug dispensing system, or as an attached additional device to the inhaler. Typically these incorporate all the system electronics including feedback mechanisms such as displays and lights, and typically have a high cost per unit, and are bulky. Multiple inhalers are managed separately, leading to system complexity.

SUMMARY

According to an example, there is provided a system for use with inhalers or nebulisers configured to deliver a medicament to a user, the system comprising at least one inhaler apparatus, the or each inhaler apparatus configured to attach to respective inhalers and adapted to detect operation or actuation of an inhaler and user-wearable or -mountable apparatus configured to receive data from the or each inhaler apparatus. The system can further comprise a remote server operable to receive data from the user-wearable or -mountable apparatus and transmit configuration data thereto and/or to the inhaler apparatus. An inhaler apparatus can be so profiled as to enable it to attach or otherwise fit on a canister, for example, of an inhaler. In this connection, a face of the inhaler apparatus may be convex for example, whereby to enable it to fit within the concave end portion of a typical inhaler canister. The inhaler apparatus may be disposable or reusable.

The inhaler apparatus is configured to attach to the top of the inhaler, or on an actuating mechanism thereof. It may attach to the canister of an inhaler. The inhaler apparatus can attach to or as part of a mouthpiece cover of the inhaler. The inhaler apparatus can comprise a transceiver configured to transmit event data to the userwearable or -mountable apparatus representing one or both of a predefined identity of the inhaler apparatus and an inhaler actuation. The user-wearable or -mountable apparatus, or wearable device, can comprise a transceiver operable to receive data from the inhaler apparatus, and to transmit data to the remote server. The inhaler apparatus can further comprise a memory configured to store historic data representing a number of inhaler actuations. The inhaler apparatus can transmit the historic data to the user-wearable or -mountable apparatus at periodic intervals and/or when the inhaler apparatus is within a communication range of the userwearable or -mountable apparatus. The inhaler apparatus can further comprise a photo-voltaic cell configured to provide power for the inhaler apparatus or a battery thereof. The inhaler apparatus can further comprise motion energy harvesting means. That is, motion of an inhaler to which the inhaler apparatus is attached can be used to harvest energy. The wearable device may include motion energy harvesting means.

The user-wearable or -mountable apparatus can further comprise a processor configured to discriminate between multiple inhaler apparatus using received predefined identities of the inhaler apparatus. The processor can be used to track use of individual ones of the multiple inhaler apparatus. The processor can be configured to generate a warning signal representing an indication that an inhaler apparatus or the contents thereof are out of date, compromised or otherwise should not be used. The user-wearable or -mountable apparatus can further comprise a processor configured to generate a reminder signal representing an indication for the user to administer an inhalation dose from a selected inhaler or set of inhalers or an indication of the availability of an inhalation dose. The user-wearable or -mountable apparatus can generate an alert signal for the user in the event of over/under -use of the inhaler apparatus, such as use exceeding a predefined number of actuations within in a given period of time. The user-wearable or -mountable apparatus can further comprise a display configured to provide the alert signal and/or wherein the user-wearable or mountable apparatus comprises means to generate a haptic, acoustic, or tactile feedback alert to the user in the form of a vibration, wrist squeeze or electrostimulation signal. The user-wearable or -mountable apparatus can further comprise an accelerometer or gyroscope configured to detect a predefined movement profile representing shaking of the inhaler apparatus or estimate the position of the user’s hand. The user-wearable or -mountable apparatus can further comprise means configured to enable it to determine a current geographic location thereof. The userwearable or -mountable apparatus can further comprise a network module configured to connect to a network, such as the internet, either directly or by using an established connection of another device such as a mobile device or hub. The user-wearable or mountable apparatus can generate an alert signal for the user on the basis of the proximity of an inhaler apparatus. The alert signal can be generated in the event that the user-wearable or -mountable apparatus is within or out of communications range of the inhaler apparatus.

The inhaler apparatus can attach to or can be configured or profiled to be provided as part of a spacer structure or of a nebuliser associated with an inhaler. An inhaler apparatus can be provided on both an inhaler and a spacer structure for example, in order to enable a determination that both are being used. That is, inhaler apparatus on an inhaler and spacer can be independently tracked to confirm correct usage (e.g. if one is used without the other, this can indicate incorrect usage, or if one is located elsewhere from the other). The user-wearable or -mountable apparatus can further comprise a colour-changing display, such as a reflective display. The inhaler apparatus can further comprise one or more display portions configured to display an alert signal or information for the user. The wearable device can detect the location of an inhaler apparatus within a predetermined range of the wearable device. The wearable device can detect the motion of an inhaler apparatus, whereby to determine whether an inhaler is being shaken, by using, inferring or determining motion of the wearable device and using proximity information representing the proximity of the wearable device and the inhaler apparatus. The wearable device can detect the motion and/or position thereof, whereby to determine user hand motion and/or position representing the action and timing of inhalation. Data can be generated at the wearable device representing correct usage of an inhaler and providing feedback data to the user using display, acoustic, haptic, or tactile means. A reminder device can receive data from the server and display or otherwise provide a reminder or user inhaler usage pattern.

The wearable device can provide an alert to the user generated on the basis of data received from the server indicating a potentially dangerous situation. The system can use location and time information to aggregate across a number of users to identify trigger conditions at certain locations or conditions in real time

According to an example, there is provided a method for use with inhalers or nebulisers configured to deliver a medicament to a user, the method comprising attaching an inhaler apparatus to an inhaler, detecting, using the inhaler apparatus, operation or actuation of an inhaler, receiving, at a user-wearable or -mountable apparatus, data from the inhaler apparatus. The method can further comprise receiving, at a remote server, data from the user-wearable or -mountable apparatus; and transmitting configuration data from the remote server to the user-wearable or mountable apparatus and/or to the inhaler apparatus. The inhaler apparatus can comprise a transceiver, the method further comprising transmitting event data to the user-wearable or -mountable apparatus representing one or both of a predefined identity of the inhaler apparatus and an inhaler actuation. The user-wearable or mountable apparatus can comprise a transceiver, the method further comprising receiving data from the inhaler apparatus, and to transmit data to the remote server. The method can further comprise storing historic data representing a number of inhaler actuations in a memory of the inhaler apparatus. The method can further comprise transmitting the historic data to the user-wearable or -mountable apparatus at periodic intervals and/or when the inhaler apparatus is within a communication range of the user-wearable or -mountable apparatus. The user-wearable or mountable apparatus can comprise a processor, the method further comprising discriminating between multiple inhaler apparatus using received predefined identities of the inhaler apparatus. The method can further comprise tracking use of individual ones of the multiple inhaler apparatus. The method can further comprise generating a warning signal representing an indication that an inhaler apparatus or the contents thereof are out of date, compromised or otherwise should not be used. The method can further comprise generating a reminder signal representing an indication for the user to administer an inhalation dose from a selected inhaler or set of inhalers or an indication of the availability of an inhalation dose. The method can further comprise generating an alert signal for the user in the event of over/under -use of the inhaler apparatus, such as use exceeding a predefined number of actuations within in a given period of time. The method can further comprise generating a haptic, acoustic, or tactile feedback alert to the user in the form of a vibration, wrist squeeze or electrostimulation signal. The method can further comprise detecting a predefined movement profile representing shaking of the inhaler apparatus. The method can further comprise determining a current geographic location of the wearable device.

The method can further comprise generating an alert signal for the user on the basis of the proximity of an inhaler apparatus to the wearable device. The alert signal can be generated in the event that the user-wearable or -mountable apparatus is within or out of communications range of the inhaler apparatus. The method can further comprise detecting the location of an inhaler apparatus within a predetermined range of the wearable device. The method can further comprise detecting the motion of an inhaler apparatus, whereby to determine whether an inhaler is being shaken. The method can further comprise detecting the motion thereof, whereby to determine user hand motion representing the action and timing of inhalation. The method can further comprise generating data, at the wearable device, representing correct usage of an inhaler and providing feedback data to the user using display, acoustic, haptic, or tactile means.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which:

Figure I is a schematic representation of a system according to an example;

Figure 2 is a schematic representation of a wearable device according to an example;

Figure 3 is a schematic representation of an inhaler apparatus; and

Figure 4 is a block diagram of a machine in the example form of a computer system according to an example.

DESCRIPTION

Example embodiments are described below in sufficient detail to enable those of ordinary skill in the art to embody and implement the systems and processes herein described. It is important to understand that embodiments can be provided in many alternate forms and should not be construed as limited to the examples set forth herein.

Accordingly, while embodiments can be modified in various ways and take on various alternative forms, specific embodiments thereof are shown in the drawings and described in detail below as examples. There is no intent to limit to the particular forms disclosed. On the contrary, all modifications, equivalents, and alternatives falling within the scope of the appended claims should be included. Elements of the example embodiments are consistently denoted by the same reference numerals throughout the drawings and detailed description where appropriate.

The terminology used herein to describe embodiments is not intended to limit the scope. The articles “a,” “an,” and “the” are singular in that they have a single referent, however the use of the singular form in the present document should not preclude the presence of more than one referent. In other words, elements referred to in the singular can number one or more, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises,” “comprising,” “includes,” and/or “including,” when used herein, specify the presence of stated features, items, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, items, steps, operations, elements, components, and/or groups thereof.

Unless otherwise defined, all terms (including technical and scientific terms) used herein are to be interpreted as is customary in the art. It will be further understood that terms in common usage should also be interpreted as is customary in the relevant art and not in an idealized or overly formal sense unless expressly so defined herein.

According to an example, there is provided a system for use with inhalers or nebulisers configured to deliver a medicament to a user. At least one inhaler apparatus is provided and the or each inhaler apparatus is configured to attach to respective inhalers and adapted to detect operation or actuation of an inhaler. An inhaler apparatus can be single use, disposable, or reusable. A user-wearable or mountable apparatus (wearable device) is configured to receive data from an inhaler apparatus and a remote server operable to receive data from the user-wearable or mountable apparatus and transmit configuration data thereto and/or to the inhaler apparatus. Herein, an inhaler can be a metered-dose inhaler, a non-metered inhaler or a nebuliser or other attachment associated with an inhaler or inhalation-type treatment. In an example, a wearable device is configured to communicatively or operatively connect or link with one or more inhaler apparatus, each of which is provided in association with or otherwise attached to respective inhalers. That is, a system can provide a wearable device that can monitor the use of multiple inhaler or inhaler-type products.

In an example, an inhaler apparatus is a device that can be attached to the end of a canister of an inhaler, or on the actuating button, or as part of a mouthpiece cover of an inhaler or as part of a spacer used with a nebuliser for example. The inhaler apparatus can be positioned on an inhaler and the like to enable actuation thereof as the inhaler is used. The inhaler apparatus can be reusable or single use/disposable, and may therefore be removably attachable, whereby to enable it to be used with another device as desired. For example, when the medicament of one inhaler to which the inhaler apparatus is attached has been exhausted, the inhaler apparatus may be removed and attached to another inhaler. The inhaler apparatus may be a retrofit device in the form of a ‘dot’ or ‘button’ that can be attached to existing inhalers or pressurised cartridges without compromising their licences, design or function. It may be adhered to an inhaler using, for example a low tack adhesive that enables it to be removed, or by way of a magnetic connection. Alternatively, or in addition, the inhaler apparatus, or a portion thereof (such as a portion configured to attach to an inhaler) may be so profiled or shaped as to enable a form-fitting engagement with an inhaler or a portion thereof.

Figure I is a schematic representation of a system 100 according to an example. Multiple inhaler apparatuses 101 (or sensors) can be communicatively or operatively linked to one wearable device 103 (user-wearable or -mountable apparatus). In an example, a short range radio frequency communications protocol, such as Bluetooth, Zigbee and so on, can be used to link an inhaler apparatus and the wearable device. In an example, the wearable device 103 can be communicatively or operatively linked to a mobile device 105 using a short range radio frequency (R.F) communications protocol, the device 105 belonging to a user 107 of an inhaler to which an inhaler apparatus 101 is attached. The wearable device 103 can be linked using a long or short range R.F communications protocol, such as WiFi or Bluetooth LE for example, to an access point or node 109 which may be communicatively linked to a server I 11 over a wired or wireless link. A user 107, parent/carer I 13 and/or clinician I 15 may be able to access data on the server I I I, either directly or via a PC, device or browser etc. In an example, the mobile device 105 may be able to link directly with the server I I I using a cellular network connection or WiFi and so on. In an example, access point 109 can be a mobile device such as a smart phone or tablet, a desktop device, such as a PC or internet enabled television, or generally any internet connected device, or it may be a dedicated hub or gateway provided only for use with the system as described herein, or a publicly available access point such as in a LoRa or NB-loT system

According to an example, an inhaler apparatus 101 can communicate with the wearable device 103 in order to transmit data representing a number of inhaler actuations. For example, data representing a number of actuations over a predefined period time can be transmitted to the device 103. The data can include the time of an actuation, and an inhaler apparatus may include a clock module to provide a time value that can be linked to an actuation in the form of metadata for example. If the inhaler apparatus 101 has a means of determining location, or was in communications range of the device 103 at the time of actuation, and the device 103 had current location data (from GPS, network or other means), then the location of the actuation event can be determined. Accordingly, a picture of user location at the time of actuation can be built up, and this can be used to determine areas where there is increased (or decreased) inhaler activity, which may indicate areas to be avoided at certain times for example.

Typically, as a short range RF protocol between an inhaler apparatus 101 and device 103 is used, the transmission will only occur when the inhaler apparatus 101 is within range of the device 103. Accordingly, the device 103 and/or an inhaler apparatus 101 can periodically poll for the presence of one another. In an example, if the device 103 and an inhaler apparatus 101 are not within range for a period of time this may indicate a communications failure.

In an example, data from the device 103 representing the actuations of an inhaler apparatus, such as the number of actuations in a given period of time, the time and/or location of an actuation and so on, can be transmitted from the device 103 to mobile device 105, either periodically or in the form of a push notification from the device 103 or a periodic pull from device 105 for example. The data can be used by device 105 to provide user 107 (or parent/carer I 13, clinician I 15 and so on) with information related to inhaler use. For example, an application can be provided on device 103 that can provide a graphical representation of inhaler actuations for a user, which can be modified by the user to indicate actuations by time and/or location and/or by inhaler device. Alternatively, the data can be provided via server I I I, for example using a graphical interface provided in a web browser or as part of an application. In this case, the mobile device can act as a bridge between an inhaler apparatus and the server to facilitate/enable the forwarding of data to the server from an inhaler apparatus.

In an example, device 103 and mobile device 105 can be communicatively linked to server I I I, either directly, or via an access point 109. The server I I I can receive data from the device 103 and/or mobile device 105 representing the actuations of an inhaler apparatus 101, such as the number of actuations in a given period of time, the time and/or location of an actuation and so on, as described above. This data can be used to generate a profile I 17 for a user indicating inhaler usage patterns, such as the number of actuations within a specific period of time, at a specific location and so on, in order to enable a user or other stakeholders to make better decisions, such as not visiting a particular area at a particular time as this tends to aggravate an ailment requiring a higher number of inhaler actuations than would otherwise be the case for example. Location and time of actuations can therefore be used to correlate and predict situations to avoid, or to require increased prophylactic doses. Data from other feeds can also be used in the generation of a profile for a user. For example, weather and/or pollen count information at the location/times of inhaler apparatus actuation can be used to track certain environmental aspects that may have affected the user’s inhaler usage. Also, data from fitness trackers can be used in order to map user activity to inhaler usage as part of the profile.

In an example, an inhaler apparatus can include environmental sensors, such as temperature, humidity sensors and so on. This can be useful for providing a track and trace function. For example, if an inhaler has been exposed to high temperatures/humidity, this can indicate that the contents may be unsuitable for inhalation or that the expiry is shortened. These data can also be made available to be associated with inhaler actuation events to determine environmental trigger conditions.

Figure 2 is a schematic representation of a wearable device according to an example. Device 200 may include a microprocessor 201, display 203, haptic feedback mechanism 205, local RF interface module 207, a clock 209, memory 21 I, long range RF interface module 213, GPS module 215, battery management device 217 and accelerometer and/or gyroscope 219. The device may also include a display driver, audio driver and speakers, and the above is not intended to be limiting.

The display 203 can be a monotone or colour display, can be fabricated from glass or plastic, and configured to present information to a user relating to inhaler usage, such as the number of inhaler actuations and so on as described above. It may also provide information such as an estimated number of doses remaining in an inhaler. For example, if a metered-dose inhaler provides a given number of doses each providing a set volume of medicament, the number of actuations of the inhaler can be used to determine the amount of medicament remaining in an inhaler, and the display can therefore be used to present the number of doses remaining. In an example, display 203 can be a colour changing display (or displays) used to provide indicators of reminder/inhaler status.

A haptic feedback mechanism 205 can be used to provide tactile or other user feedback, such as a reminder for user to administer a dose of medication from an inhaler. In an example, a reminder can be configured and stored in memory 21 I. At a predetermined time, determinable using clock 209, the reminder can be issued to the user using the haptic feedback engine 205. In addition, an audible and/or visual reminder may be provided. A further reminder provided using the mobile device 105 can also be provided in addition or in place of this reminder. In an example, the system may be configured to only give a prompt to the user if they have forgotten to administer a dose of medication during a certain time window.

In an example, a reminder can be an indication that an inhaler can be used (for example, in the case of a PRN (“taken as required” up to a limit) dose).

Local RF interface module 207 is used to provide short range RF communication to the inhaler apparatus. For example, the module 207 may be a Bluetooth or Zigbee module. In an example, the device may be able to communicate with an inhaler apparatus using infra-red or ultrasound instead of, or in addition to, RF communication. Clock 209 can be used to provide a real time signal for the device 200. In an example, it may derive a time signal using the GPS module 215. A long range RF interface module 213 is used to provide WiFi connectivity (802.1 lx), for example, 3G/4G or other low power wide area network protocols such as LoRa or NB-loT for example. Battery management device 217 is used to control a power supply (battery) for the device. For example, power supply from a battery can be monitored and controlled in order to provide a warning signal indicating low power when a certain low voltage threshold for a battery is reached. The device 200 may be adapted to harvest energy from movement and/or using photo-voltaic cells for example.

An accelerometer and/or gyroscope 219 is provided to enable a motion and/or position of the device 200 to be determined. For example, the action of shaking an inhaler can be linked to a predetermined motion that can be detected using a signal from the accelerometer and/or gyroscope 219. If the inhaler apparatus is in close proximity to the device 200, then the action of shaking the inhaler as part of the correct dosing procedure can be inferred. The approximate position of the user’s hand whilst holding the inhaler and inhaler apparatus may also be inferred and used to determine whether the inhalation process has been correctly followed. Incorrect inhalation process can be detected and information can be fed back to the user to aid improved inhalation methods. Poor inhalation technique can be monitored and data fed back to the server for further analysis and reporting to users, carers and clinicians. In an example, the wearable device can time how long an inhaler is shaken and the time between shakes (to infer time between breaths - typical dose may be 2 breaths). That feedback could be shown in a display of the device - e.g. shake for longer, wait for longer between doses etc.

In an example, a wearable device does not rely on a real-time link to the server, but buffers up event and tracking information that can be transmitted periodically or on demand. The wearable device can provide an alert to the user generated on the basis of data received from the server indicating a potentially dangerous situation. For example, if a profile for a user indicates that certain weather, locations and/or times of time result in higher than average use of an inhaler, and such conditions, locations and times are detected, an alert can be provided to the user in order to give them chance to remove themselves from a potentially dangerous situation. The alert may also be provided using the mobile device. For example, an email or text message alert or notification can be provided.

According to an example, an inhaler apparatus can have a similar form factor to a coin cell and can be configured to fit neatly into the dimple on the end of an inhaler canister. It will typically be small and unobtrusive as it is adapted to use short range RF communications and does not therefore require bulky long range RF modules and associated power supplies and does not include any means for providing feedback on the inhaler apparatus itself.

According to an example, an inhaler apparatus actuation sensor could be integrated with an inhaler mouthpiece cap such that a removal of the cap could be detected and logged. That is, removing the cap would automatically send a signal indicating that the inhaler has been used.

The wearable device sits between the inhalers and the connection to the data server, which may be a cloud-based server for example, by using the mobile device, which may be a smartphone for example, as a bridging device, or going directly to the cloud using a low power wide area network protocol (e.g. LoRa or NB-loT).

The wearable device 200 can be locally programmable via an application for example, or can be remotely programmable via the server I I I. For example, reminders can be set, and inhaler details can be updated or modified as required (e.g. if the device is linked to more than one inhaler apparatus). The device can be used to give an indication of the proximity of an inhaler so that they are not forgotten (e.g. when leaving the house), and can give feedback on adherence and warnings of trigger conditions.

Figure 3 is a schematic representation of an inhaler apparatus according to an example. The apparatus (300) includes a microprocessor (301), a power source (302), a memory (303), a realtime clock (304), a means for detecting the actuation of the inhaler (305) and a local communications interface (306). The parts 301,303,304 and 306 may be practically incorporated into a single electronic component, minimising cost and physical size.

The communications interface (306) may be via radio frequency (RF) means, or any other suitable means, ultrasonic or infrared for example.

The actuation detection (305) may be a simple contact switch for example on the canister or body of the inhaler, or to detect the removal of the mouthpiece, or presence of the user’s mouth, or acoustically detecting the expulsion of medication for example. The actuation detection (305) may also be an optical, magnetic or electromagnetic sensor to determine dose release or the change in state of the delivery mechanism.

The power source (302) may be a simple primary battery cell, or rechargeable secondary cell, or may incorporate energy harvesting from the actuation of the inhaler for example.

In an example the inhaler apparatus (300) may also be attached to a spacer, nebuliser or other component of an inhalation medication system, and the proximity of these additional devices used to indicate correct use of the system. A spacer structure can be in the form of a cavity used to receive a gaseous medicament for inhalation for example.

In an example, the server III, which can be provided as part of a cloud based system can manage multiple users and multiple medications/inhalers per user and provide views on real time and historic data. Data received from mobile devices and/or wearable devices can be used to correlate location and other environmental data with inhaler usage and can automatically produce trigger warnings based on location, recent use and public information (pollen counts for example). A separate reminder device I 18 may be provided that can receive data from server I I I and provide reminders and/or provide feedback/prompts to a user, parents etc.

In an example, the server I I I may provide data to a remote information device I 18 which is capable of showing the status of the user’s inhaler system, and for example the level of adherence to a regular regime of ‘preventor’ inhalation, or current trend in the use of ‘reliever’ inhalers. This remote information device may be located for example in the home of the user, or the home of their carer or family member to provide reassurance and passive monitoring.

In an example the server I I I may analyse data in real time and provide alert message by means of SMS, email or other messaging services to indicate usage patterns, unexpected or dangerous situations to the user, carers or clinicians.

Certain embodiments are described herein as including logic or a number of components, modules, or mechanisms. Modules may constitute either software modules (e.g., code embodied on a machine-readable medium or in a transmission signal) or hardware modules. A hardware module is a tangible unit capable of performing certain operations and may be configured or arranged in a certain manner. In example embodiments, one or more computer systems (e.g., a standalone, client, or server computer system) or one or more hardware modules of a computer system (e.g., a processor or a group of processors) may be configured by software (e.g., an application or application portion) as a hardware module that operates to perform certain operations as described herein.

In various embodiments, a hardware module may be implemented mechanically or electronically. For example, a hardware module may comprise dedicated circuitry or logic that is permanently configured (e.g., as a special-purpose processor, such as a field programmable gate array (FPGA) or an application-specific integrated circuit (ASIC)) to perform certain operations. A hardware module may also comprise programmable logic or circuitry (e.g., as encompassed within a general-purpose processor or other programmable processor) that is temporarily configured by software to perform certain operations. It will be appreciated that the decision to implement a hardware module mechanically, in dedicated and permanently configured circuitry, or in temporarily configured circuitry (e.g., configured by software) may be driven by cost and time considerations.

Accordingly, the term “hardware module”, “module”, “system component” or “engine” should be understood to encompass a tangible entity, be that an entity that is physically constructed, permanently configured (e.g., hardwired) or temporarily configured (e.g., programmed) to operate in a certain manner and/or to perform certain operations described herein. Considering embodiments in which hardware modules are temporarily configured (e.g., programmed), each of the hardware modules need not be configured or instantiated at any one instance in time. For example, where the hardware modules comprise a general-purpose processor configured using software, the general-purpose processor may be configured as respective different hardware modules at different times. Software may accordingly configure a processor, for example, to constitute a particular hardware module at one instance of time and to constitute a different hardware module at a different instance of time.

Hardware modules can provide information to, and receive information from, other hardware modules. Accordingly, the described hardware modules or system components may be regarded as being communicatively coupled. Where multiple of such hardware modules exist contemporaneously, communications may be achieved through signal transmission (e.g., over appropriate circuits and buses) that connect the hardware modules. In embodiments in which multiple hardware modules are configured or instantiated at different times, communications between such hardware modules may be achieved, for example, through the storage and retrieval of information in memory structures to which the multiple hardware modules have access. For example, one hardware module may perform an operation and store the output of that operation in a memory device to which it is communicatively coupled.

A further hardware module may then, at a later time, access the memory device to retrieve and process the stored output. Hardware modules may also initiate communications with input or output devices and can operate on a resource (e.g., a collection of information).

The various operations of example methods described herein may be performed, at least partially, by one or more processors that are temporarily configured (e.g., by software) or permanently configured to perform the relevant operations. Whether temporarily or permanently configured, such processors may constitute processorimplemented modules that operate to perform one or more operations or functions. The modules referred to herein may, in some example embodiments, comprise processor-implemented modules.

Similarly, the methods described herein may be at least partially processorimplemented. For example, at least some of the operations of a method may be performed by one or more processors or processor-implemented modules. The performance of certain of the operations may be distributed among the one or more processors, not only residing within a single machine, but deployed across a number of machines. In some example embodiments, the processor or processors may be located in a single location (e.g., within a home environment, an office environment or as a server farm), while in other embodiments the processors may be distributed across a number of locations.

The one or more processors may also operate to support performance of the relevant operations in a “cloud computing” environment or as a “software as a service” (SaaS). For example, at least some of the operations may be performed by a group of computers (as examples of machines including processors), these operations being accessible via a network and via one or more appropriate interfaces (e.g., APIs).

Example embodiments may be implemented in digital electronic circuitry, or in computer hardware, firmware, software, or in combinations of them. Example embodiments may be implemented using a computer program product, e.g., a computer program tangibly embodied in an information carrier, e.g., in a machinereadable medium for execution by, or to control the operation of, data processing apparatus, e.g., a programmable processor, a computer, or multiple computers.

A computer program can be written in any form of programming language, including compiled or interpreted languages, and it can be deployed in any form, including as a stand-alone program or as a module, subroutine, or other unit suitable for use in a computing environment. A computer program can be deployed to be executed on one computer or on multiple computers at one site or distributed across multiple sites and interconnected by a communication network.

In example embodiments, operations may be performed by one or more programmable processors executing a computer program to perform functions by operating on input data and generating output. Method operations can also be performed by, and apparatus of example embodiments may be implemented as, special purpose logic circuitry (e.g., a FPGA or an ASIC).

A computing system can include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. In embodiments deploying a programmable computing system, it will be appreciated that both hardware and software architectures merit consideration. Specifically, it will be appreciated that the choice of whether to implement certain functionality in permanently configured hardware (e.g., an ASIC), in temporarily configured hardware (e.g., a combination of software and a programmable processor), or a combination of permanently and temporarily configured hardware may be a design choice. Below are set out hardware (e.g., machine) and software architectures that may be deployed, in various example embodiments.

Figure 4 is a block diagram of a machine in the example form of a computer system 800 within which instructions 824 for causing the machine to perform any one or more of the methodologies discussed herein may be executed, in accordance with an example embodiment. In alternative embodiments, the machine operates as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine may operate in the capacity of a server or a client machine in a server-client network environment, or as a peer machine in a peer-topeer (or distributed) network environment. The machine may be a personal computer (PC), a tablet PC, a set-top box (STB), a Personal Digital Assistant (PDA), a cellular telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. Further, while only a single machine is illustrated, the term “machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein.

The example computer system 800 includes a processor 802 (e.g., a central processing unit (CPU), a graphics processing unit (GPU) or both), a main memory 804 and a static memory 806, which communicate with each other via a bus 808. The computer system 800 may further include a video display unit 810 (e.g., a liquid crystal display (LCD) or a cathode ray tube (CRT)). The computer system 800 also includes an alphanumeric input device 812 (e.g., a keyboard), a user interface (Ul) navigation (or cursor control) device 814 (e.g., a mouse), a disk drive unit 816, a signal generation device 818 (e.g., a speaker) and a network interface device 820.

The disk drive unit 816 includes a machine-readable medium 822 on which is stored one or more sets of data structures and instructions 824 (e.g., software) embodying or utilized by any one or more of the methodologies or functions described herein. The instructions 824 may also reside, completely or at least partially, within the main memory 804 and/or within the processor 802 during execution thereof by the computer system 800, the main memory 804 and the processor 802 also constituting machine-readable media. The instructions 824 may also reside, completely or at least partially, within the static memory 806.

While the machine-readable medium 822 is shown in an example embodiment to be a single medium, the term machine-readable medium may include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) that store the one or more instructions 824 or data structures. The term machine-readable medium shall also be taken to include any tangible medium that is capable of storing, encoding or carrying instructions for execution by the machine and that cause the machine to perform any one or more of the methodologies of the present embodiments, or that is capable of storing, encoding or carrying data structures utilized by or associated with such instructions. The term machinereadable medium shall accordingly be taken to include, but not be limited to, solidstate memories, and optical and magnetic media. Specific examples of machinereadable media include non-volatile memory, including by way of example semiconductor memory devices (e.g., Erasable Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM), and flash memory devices); magnetic disks such as internal hard disks and removable disks; magneto-optical disks; and compact disc-read-only memory (CD-ROM) and digital versatile disc (or digital video disc) read-only memory (DVD-ROM) disks.

The instructions 824 may further be transmitted or received over a communications network 826 using a transmission medium. The instructions 824 may be transmitted using the network interface device 820 and any one of a number of well-known transfer protocols (e.g., HTTP). Examples of communication networks include a LAN, a WAN, the Internet, mobile telephone networks, POTS networks, and wireless data networks (e.g., WiFi and WiMax networks). The term transmission medium shall be taken to include any intangible medium capable of storing, encoding, or carrying instructions for execution by the machine, and includes digital or analog communications signals or other intangible media to facilitate communication of such software.

Although an embodiment has been described with reference to specific example embodiments, it will be evident that various modifications and changes may be made to these embodiments without departing from the scope of the present disclosure. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense. The accompanying drawings that form a part hereof, show by way of illustration, and not of limitation, specific embodiments in which the subject matter may be practiced. The embodiments illustrated are described in sufficient detail to enable those skilled in the art to practice the teachings disclosed herein.

Other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. This description, therefore, is not to be taken in a limiting sense, and the scope of various embodiments is defined only by the appended claims, along with the full range of equivalents to which such claims are entitled.

Although specific embodiments have been illustrated and described herein, it should be appreciated that any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

The present inventions can be embodied in other specific apparatus and/or methods. The described embodiments are to be considered in all respects as illustrative and not restrictive. In particular, the scope of the invention is indicated by the appended claims rather than by the description and figures herein. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

1. A system for use with inhalers or nebulisers configured to deliver a medicament to a user, the system comprising:

at least one inhaler apparatus, the or each inhaler apparatus configured to attach to respective inhalers and adapted to detect operation or actuation of an inhaler; and user-wearable or -mountable apparatus configured to receive data from the or each inhaler apparatus.

2. A system as claimed in claim I, further comprising a remote server operable to: receive data from the user-wearable or -mountable apparatus; and transmit configuration data thereto and/or to the inhaler apparatus.

3. A system as claimed in claim I or 2, wherein the inhaler apparatus is configured to attach to the top of the inhaler, or on an actuating mechanism thereof.

4. A system as claimed in any preceding claim, wherein the inhaler apparatus is configured to attach to or as part of a mouthpiece, or mouthpiece cover of the inhaler.

5. A system as claimed in any preceding claim, wherein the inhaler apparatus comprises a transceiver configured to transmit event data to the user-wearable or mountable apparatus representing one or both of a predefined identity of the inhaler apparatus and an inhaler actuation.

6. A system as claimed in any preceding claim, wherein the user-wearable or mountable apparatus comprises a transceiver operable to receive data from the inhaler apparatus, and to transmit data to the remote server.

7. A system as claimed in any preceding claim, wherein the inhaler apparatus further comprises a memory configured to store historic data representing a number of inhaler actuations.

8. A system as claimed in claim 7, wherein the inhaler apparatus is configured to transmit the historic data to the user-wearable or -mountable apparatus at periodic intervals and/or when the inhaler apparatus is within a communication range of the user-wearable or -mountable apparatus.

9. A system as claimed in any preceding claim, wherein the inhaler apparatus further comprises a photo-voltaic cell configured to provide power for the inhaler apparatus or a battery thereof.

10. A system as claimed in any of claims I to 9, wherein the inhaler apparatus further comprises motion energy harvesting means.

I I. A system as claimed in any preceding claim, wherein the user-wearable or mountable apparatus further comprises a processor configured to discriminate between multiple inhaler apparatus using received predefined identities of the inhaler apparatus.

12. A system as claimed in claim I I, wherein the processor is further configured to track use of individual ones of the multiple inhaler apparatus.

13. A system as claimed in claim I I or 12, wherein the processor is further configured to generate a warning signal representing an indication that an inhaler apparatus or the contents thereof are out of date, compromised or otherwise should not be used.

14. A system as claimed in any preceding claim, wherein the user-wearable or mountable apparatus further comprises a processor configured to generate a reminder signal representing an indication for the user to administer an inhalation dose from a selected inhaler or set of inhalers or an indication of the availability of an inhalation dose.

15. A system as claimed in any preceding claim, wherein the user-wearable or mountable apparatus is configured to generate an alert signal for the user in the event of over/under -use of the inhaler apparatus, such as use exceeding a predefined number of actuations within in a given period of time.

16. A system as claimed in claim 15, wherein the user-wearable or -mountable apparatus further comprises a display configured to provide the alert signal and/or wherein the user-wearable or -mountable apparatus comprises means to generate a haptic, acoustic, or tactile feedback alert to the user in the form of a vibration, wrist squeeze or electrostimulation signal.

17. A system as claimed in any preceding claim, wherein the user-wearable or mountable apparatus further comprises an accelerometer or gyroscope configured to detect a predefined movement profile representing shaking of the inhaler apparatus or estimate the position and movement of the user’s hand.

18. A system as claimed in any preceding claim, wherein the user-wearable or mountable apparatus further comprises means configured to enable it to determine a current geographic location thereof.

19. A system as claimed in any preceding claim, wherein the user-wearable or mountable apparatus further comprises a network module configured to connect to a network, such as the internet, either directly or by using an established connection of another device such as a mobile device or hub.

20. A system as claimed in any preceding claim, wherein the user-wearable or mountable apparatus is configured to generate an alert signal for the user on the basis of the proximity of an inhaler apparatus.

21. A system as claimed in claim 20, wherein the alert signal is generated in the event that the user-wearable or -mountable apparatus is within or out of range of the inhaler apparatus.

22. A system as claimed in any preceding claim, wherein the inhaler apparatus is configured to attach to or is configured to be provided as part of a spacer structure or of a nebuliser.

23. A system as claimed in any preceding claim, wherein the user-wearable or mountable apparatus further comprises a colour-changing display.

24. A system as claimed in any preceding claim, wherein the inhaler apparatus further comprises one or more display portions configured to display an alert signal or information for the user.

25. A system as claimed in any preceding claim, wherein the wearable device is configured to detect the location of an inhaler apparatus within a predetermined range of the wearable device.

26. A system as claimed in any preceding claim, wherein the wearable device is configured to detect the motion of an inhaler apparatus, whereby to determine whether an inhaler is being shaken, by using, inferring or determining motion of the wearable device and using proximity information representing the proximity of the wearable device and the inhaler apparatus.

27. A system as claimed in any preceding claim, wherein the wearable device is configured to detect the motion and/or position thereof, whereby to determine user hand motion and/or position representing the action and timing of inhalation.

28. A system as claimed in any preceding claim, further comprising generating data, at the wearable device, representing correct usage of an inhaler and providing feedback data to the user using display, acoustic, haptic, or tactile means.

29. A system as claimed in any preceding claim, further comprising a reminder device configured to receive data from the server and display or otherwise provide a reminder or user inhaler usage pattern.

30. A system as claimed in any preceding claim, wherein the wearable device is configured to provide an alert to the user generated on the basis of data received from the server indicating a potentially dangerous situation.

3 I. A system as claimed in any preceding claim, wherein the system uses location and time information to aggregate across a number of users to identify trigger conditions at certain locations or conditions in real time

32. A method for use with inhalers or nebulisers configured to deliver a medicament to a user, the method comprising:

attaching an inhaler apparatus to an inhaler; detecting, using the inhaler apparatus, operation or actuation of an inhaler; and receiving, at a user-wearable or -mountable apparatus, data from the inhaler apparatus.

33. A method as claimed in claim 32, further comprising:

receiving, at a remote server, data from the user-wearable or -mountable apparatus; and transmitting configuration data from the remote server to the userwearable or -mountable apparatus and/or to the inhaler apparatus.

34. A method as claimed in claim 32 or 33, wherein the inhaler apparatus comprises a transceiver, the method further comprising transmitting event data to the user-wearable or -mountable apparatus representing one or both of a predefined identity of the inhaler apparatus and an inhaler actuation.

35. A method as claimed in claim 32 or 35, wherein the user-wearable or mountable apparatus comprises a transceiver, the method further comprising receiving data from the inhaler apparatus, and to transmit data to the remote server.

36. A method as claimed in any of claims 32 to 35, further comprising storing historic data representing a number of inhaler actuations in a memory of the inhaler apparatus.

37. A method as claimed in claim 36, further comprising transmitting the historic data to the user-wearable or -mountable apparatus at periodic intervals and/or when the inhaler apparatus is within a communication range of the user-wearable or mountable apparatus.

38. A method as claimed in any of claims 32 to 37, wherein the user-wearable or mountable apparatus comprises a processor, the method further comprising discriminating between multiple inhaler apparatus using received predefined identities of the inhaler apparatus.

39. A method as claimed in claim 38, further comprising tracking use of individual ones of the multiple inhaler apparatus.

40. A method as claimed in claim 38 or 39, further comprising generating a warning signal representing an indication that an inhaler apparatus or the contents thereof are out of date, compromised or otherwise should not be used.

41. A method as claimed in any of claims 32 o 40, further comprising generating a reminder signal representing an indication for the user to administer an inhalation dose from a selected inhaler or a selected set of inhalers or an indication of the availability of an inhalation dose.

42. A method as claimed in any of claims 32 to 41, further comprising generating an alert signal for the user in the event of over/under -use of the inhaler apparatus, such as use exceeding a predefined number of actuations within in a given period of time.

43. A method as claimed in any of claims 32 to 42, further comprising generating a haptic, acoustic, or tactile feedback alert to the user in the form of a vibration, wrist squeeze or electrostimulation signal.

44. A method as claimed in any of claims 32 to 43, further comprising detecting a predefined movement profile representing shaking of the inhaler apparatus.

45. A method as claimed in any of claims 32 to 44, further comprising determining a current geographic location of the wearable device.

46. A method as claimed in any of claims 32 to 45, further comprising generating an alert signal for the user on the basis of the proximity of an inhaler apparatus to the wearable device.

47. A method as claimed in claim 46, wherein the alert signal is generated in the event that the user-wearable or -mountable apparatus is within or out of communications range of the inhaler apparatus.

48. A method as claimed in any of claims 32 to 47, further comprising detecting the location of an inhaler apparatus within a predetermined range of the wearable device.

49. A method as claimed in any of claims 32 to 48, further comprising detecting the motion of an inhaler apparatus, whereby to determine whether an inhaler is being shaken.

50. A method as claimed in any of claims 32 to 49, further comprising detecting the motion and/or position thereof, whereby to determine user hand motion and/or position representing the action and timing of inhalation.

51. A method as claimed in any of claims 32 to 50, further comprising generating data, at the wearable device, representing correct usage of an inhaler and providing feedback data to the user using display, acoustic, haptic, or tactile means.

52. A system, substantially as hereinbefore described, with reference to and as shown in the accompanying drawings.

53. A method, substantially as hereinbefore described, with reference to the accompanying drawings.

Intellectual

Property

Office

Application No: GB1613074.2 Examiner: Mr Geraint Davies