FIELD OF THE INVENTION The present invention relates to a method of counting medicament doses dispensed by an inhaler; an electronic device for counting medicament doses dispensed by the inhaler; a system comprising the inhaler and the electronic device and a container, such as a pressurised metered dose inhaler canister or a dry powder reservoir, comprising the medicament to be administered by the inhaler.

BACKGROUND OF THE INVENTION

Inhalers are well known for providing medicament to patients. Well known inhaler types include pressurised metered dose inhalers (pMDIs) and dry powder inhalers (DPIs). They each have a container including a medicament. A user uses a pMDI to deliver an amount of an aerosolized medicament from the container to their lungs. A user uses a DPI to deliver medicament from the container or reservoir in the form of a dry powder to their lungs. Both types of inhaler are used for treating asthma, chronic obstructive pulmonary disease (COPD) as well as other conditions.

Effective treatment of many conditions using inhalers of these types requires the regular administration of a dose of medicament. An inhaler, and in particular the medicament container of an inhaler, provides only a limited number of doses. It is useful to count the number of doses so that a user knows when an inhaler will run out of medicament to deliver to a user. In regulated markets, a dose counter is mandatory for bronchodilators, and other rescue medication that patients take in the event of an exacerbation.

Many mechanical arrangements are known for counting medicament doses provided by an inhaler. One example is described in international patent application with publication No. WO 98/28033 in the name of Norton Healthcare Limited and it is illustrated in Figures 1 to 3 in which like features have been given like reference numerals. The inhaler dose counting mechanism 10 illustrated uses a pawl and ratchet mechanism 12 that is stepwise rotated each time canister 14 with medicament is pushed down to rotate a counter 16. As with this type of mechanical arrangement generally, this example is complex and bulky. This type of mechanism adds significantly to the cost of an inhaler. Many "smart" inhalers are known that provide electronic communication from an inhaler to a computer such as a smartphone, tablet, laptop or desktop computer.

These arrangements include the Smartinhaler Platform from Adherium that is used with inhalers provided by GSK and Boehringer Ingelheim; the SmartTurbo2 and Turbu+ systems again provided by Adherium that integrates with inhalers from AstraZeneca; Propeller Health's Propeller Sensor; Gecko Health's arrangement called CareTRx; Cohero Health's HeroTracker and Spirothor products; LifeMap Solutions' product that communicates with their Asthma Health application; and Amiko's Amiko Smart Tracker device. These many arrangements all use Bluetooth (registered trade mark) wireless technology for communication between inhaler and computer. Bluetooth is a standard for exchanging data between electronic devices over short distances using short-wavelength radio waves. Both the transmitter and receiver of a pair of devices communicating using Bluetooth require an electrical power source either from a battery or mains supply. "Classic" Bluetooth has quite high power requirements and the more recent version called Bluetooth Low Energy has lower power requirements, but still requires an appreciable power supply. Thus, all of these types of "smart" inhaler require a battery as a power supply. This impacts considerably on the cost of providing a "smart" inhaler even though in these arrangements the "smart" Bluetooth transceiver part of the inhaler is provided in a detachable and reusable portion.

BRIEF SUMMARY OF THE INVENTION

The inventors of the arrangement described herein have appreciated that a "smart" inhaler that communicates with a computer such as a smartphone, tablet or smartwatch or other separate electronic device can be provided using a near field communication (NFC) tag attached to an inhaler for the communication. In the embodiments described herein, the inhaler is used for counting medicament doses provided by the inhaler for which the use of NFC is particularly advantageous. Near field communication uses electromagnetic induction between an antenna of the NFC tag and an antenna of the electronic device communicating with it for communication between the NFC tag and the electronic device. The NFC tag does not have or require its own power supply. Power is provided from the electronic device (for example, the smartphone or smartwatch) communicating with the tag. In this way, a simple and low cost "smart" inhaler is provided particularly for medicament dose counting. Compared to a Bluetooth arrangement, this arrangement is more secure, smaller and no time-consuming pairing is required (where Bluetooth devices form a communication connection with one another) between the inhaler and electronic device. Additionally, it is significantly lower cost and physically smaller in size. It could even be utilised within a stick-on label, for example.

In the arrangements described below, the inhaler comprising a NFC tag is located near to or touched against a separate electronic device to which an appropriate software application is installed. Each time a user takes a medicament dose from the inhaler, the inhaler is located near to or touched against the separate electronic device and a dose count is incremented by one. The dose counter may be provided by a store or memory of the NFC tag or by a store or memory of the electronic device. While the inventors of the arrangement have appreciated that this arrangement may not give a completely accurate measure of the dose count if the user fails to locate the inhaler near to or touch it against the separate electronic device after every dose, the inventors have appreciated that such a dose counter is good enough for many purposes and provides surprisingly useful data despite the simplicity of the device.

The invention in its various aspects is defined in the independent claims below to which reference should now be made. Advantageous features are set forth in the dependent claims. According to the present invention it is provided a method of counting medicament doses dispensed by an inhaler, the inhaler comprising a passive electronic tag for communication with a separate electronic device, the method comprising: locating the inhaler near or touching the inhaler against the separate electronic device such that communication is established between the passive electronic tag and the separate electronic device; and in response, the separate electronic device incrementing a dose counter associated with the inhaler.

In a preferred embodiment the passive electronic tag comprises a near field communication tag, possibly comprising a store. Such store can include one or more of the following: an identifier of the inhaler, the dose counter, a location associated with the inhaler, wherein the location can comprise position of registration of the inhaler; also the store can include storing time of registration of the inhaler.

The separate electronic device can comprise a computer, and is selected from a smartphone, a laptop computer, a desktop computer, a tablet computer, a smartwatch or another electronic wearable device. In an embodiment the separate electronic device includes the dose counter. In an embodiment the inhaler is a pressurised metered dose inhaler (pMDI) or a dry powder inhaler (DPI).

In an embodiment, in response to the fact that the inhaler is located near to or touched against the separate electronic device, the said separate electronic device also provides data input means for inputting data into the separate electronic device associated with the inhaler.

The inhaler can comprise a container, selected from a pMDI canister or a reservoir of a DPI, both including the medicament and wherein the passive electronic tag is located on the container.

According to another aspect of the present invention it is provided an electronic device for counting medicament doses dispensed by an inhaler, the electronic device comprising: a passive electronic tag reader; and the electronic device being configured such that, in use: when an inhaler comprising a passive electronic tag that can form a communication connection with the electronic device is located near to, or touching the electronic device, communication is established between the passive electronic tag and the passive electronic tag reader; and the electronic device increments a dose counter associated with the inhaler. The electronic device can further comprise one or more components for implementing the method steps described above.

Also, the present invention provides a system comprising: an inhaler including a passive electronic tag for communication with an electronic device; and an electronic device including: a passive electronic tag reader; and the electronic device being configured such that, in use: when an inhaler comprising a passive electronic tag that can form a communication connection with the electronic device is located near to or touching the electronic device, communication is established between the passive electronic tag and the passive electronic tag reader; and the electronic device increments a dose counter associated with the inhaler. The system can further comprise one or more components for implementing the method steps described above.

Also provided is a container comprising a medicament for an inhaler, the container comprising a passive electronic tag for communication with an electronic device; the container being configured such that, in use: when the container is located near to or touching the electronic device, communication is established between the passive electronic tag and the passive electronic tag reader; and the electronic device increments a dose counter associated with the container. The container can be adapted to be used in the system defined above. An inhaler, including the container is also provided.

According to a further aspect of the present invention a computer program comprises computer program code means which, when run on a computer, implement the method steps described above.

Arrangements are described in more detail below and take the form of a method of counting medicament doses dispensed by an inhaler, the inhaler comprising a passive electronic tag for communication with a separate electronic device. The method comprises: locating the inhaler near or touching the inhaler against the separate electronic device such that communication is established between the passive electronic tag and the separate electronic device. In response, the separate electronic device increments the dose counter associated with the inhaler.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described in more detail, by way of example, with reference to the accompanying drawings, in which:

Figure 1 (prior art) is a cross-sectional view through a pMDI showing a counter mechanism;

Figure 2 (prior art) is a cross-sectional view taken at right angles to the view of Figure 1 ; Figure 3 (prior art) is a schematic perspective view of part of the pMDI of Figures 1 and 2;

Figure 4 is a perspective view of a pMDI for use in the method embodying an aspect of the present invention; Figure 5 is a cross section through the inhaler of Figure 4 for use in the method embodying an aspect of the present invention;

Figure 6 is a schematic diagram illustrating the method embodying an aspect of the present invention; and

Figure 7 is a cross section through a pMDI embodying an aspect of the present invention. DETAILED DESCRIPTION OF THE INVENTION

An example method of counting medicament doses dispensed by an inhaler 100 will now be described with reference to Figures 4 to 6 as well as an electronic device 102 for counting medicament doses dispensed by the inhaler and a container, such as a canister, for the inhaler. Like features in Figures 4 to 6 have been given like reference numerals. The features of Figures 4 to 7 relate to an inhaler provided with a NFC tag which is a pMDI. The same NFC, with same functionality, can also be applied to an inhaler represented by a multidose DPI, which delivers multiple, single doses of a medicament powder from a reservoir or, in alternative, also by a single-dose DPI that delivers single doses of a medicament powder packaged separately. These kinds of inhalers are all included in the present invention.

The NFC tag may be attached on the external surface of the inhaler (pMDI or DPI) or on the external surface of the medicament container which is the aerosol canister for a pMDI or the medicament reservoir for a multidose DPI.

The inhaler 100 of Figures 4 and 5 is a pMDI largely of known arrangement. It includes a container in the form of a canister 104 containing medicament to be released in aerosol form. The canister is housed in a housing portion 106 of a plastics casing 108. The casing also includes a mouthpiece 1 10 for inserting into a user's mouth that extends laterally to the housing portion. An outlet 1 12 of the canister, through which medicament is released from the canister, is located within a fluid dispenser 1 14. The fluid dispenser is arranged such that as the outlet of the canister is pushed against it, fluid is released from the canister laterally to the canister and out through the mouthpiece. In Figures 4 and 5, a cap 1 16 is shown covering the mouthpiece.

To dispense medicament from the inhaler, the cap 1 16 is removed by a user. The mouthpiece 1 10 is then inserted by a user into his mouth. The user then presses the canister 104 against the fluid dispenser 1 14 and a dose of medicament is released from the outlet 1 12 of the canister and the dispensed medicament passes laterally from the outlet of the canister through the mouthpiece, into the user's mouth and onwards to their lungs.

Significantly, the inhaler 100 of Figures 4 and 5 also includes an NFC tag or label 120 . The NFC tag is located on the outside of the inhaler on the casing 108 and, in particular, on a base 122 of the housing portion 106 of the casing. The NFC tag is located adjacent the mouthpiece 1 10 and facing the canister 104. The NFC tag is attached to the casing by adhesive. The NFC tag is a passive electronic tag. It is called a passive electronic tag because it does not have its own power supply. The NFC tag has an antenna (not shown). It uses electromagnetic induction between this antenna and an antenna of an NFC tag reader of the electronic device communicating with it for communication between the NFC tag and the NFC tag reader of the electronic device. The NFC tag has stored in it a unique identifier to uniquely identify the inhaler. While an NFC tag is illustrated, a different passive electronic tag in the form of another radio frequency identification (RFID) tag could be provided.

Figure 6 illustrates the method of counting medicament doses dispensed by the inhaler 100 using a separate electronic device 102 comprising a passive electronic tag reader in the form of an NFC tag reader, and dose counter implemented in software. In this example, the separate electronic device is a smartphone. However, the electronic device may comprise another type of computer including a passive electronic tag reader and appropriate software, such as a laptop computer, desktop computer, tablet computer, smartwatch or other electronic wearable device including a display.

Firstly, as illustrated at step 200, a user takes a dose of medicament from the inhaler 100 as described above. As illustrated at the next step, step 210, the user then locates the inhaler near the smartphone 102 or touches the inhaler against the smartphone. Communication is then established between the NFC tag 120 and the NFC tag reader of the smartphone. In response, as illustrated at step 220, the smartphone increments the dose counter by one as illustrated by the indication of the number of doses taken 222 displayed on the display 224 of the smartphone.. The smartphone display also displays other useful data such as the doses remaining 226 and the time until the next dose needs to be taken 228.

The doses remaining is initiated by the user when the user has a new inhaler 100 based on the expected number of doses from the inhaler. As mentioned above, each NFC tag 120 has stored in it a unique identifier for the inhaler. When a user locates the inhaler near the smartphone 102 or touches the inhaler against the smartphone for the first time, the smartphone asks the user if this is a new inhaler that they are to use. If the user responds that it is new, the smartphone uses the unique identifier provided by the NFC tag to identify the inhaler type and its known total number of doses based on data stored in the smartphone or in a remote database (not illustrated) in communication with the smartphone. The total number of doses is then stored in the smartphone's memory. The smartphone then decrements this number by one every time that the dose counter is incremented by one and the new number of doses remaining is stored in the smartphone's memory and displayed on the smartphone's display 224. Rather than the identity of the inhaler being used to obtain information on the total number of doses that can be provided by the inhaler, the NFC tag may store the number of doses that can be delivered and this information can be provided to the smartphone directly. The NFC tag 120 is also used to provide the time between doses. In a similar way to how the total number of doses is provided described above, the time between doses may be provided to the smartphone 102 based on the identity of the inhaler as provided by the NFC tag and then by interrogation of a database that holds the time between doses for the identified inhaler where the database is either stored on the smartphone or remotely. The NFC tag may also store the time between doses on it and this may be provided directly to the smartphone the first time that the inhaler communicates with the smartphone.

Significantly, the use of a passive electronic tag means that the smartphone does not need to connect to a remote computer server based or cloud based service in order to obtain relevant information.

An alternative arrangement to that of Figures 4 to 6 is illustrated in Figure 7. The arrangement of Figure 7 is similar in most respects to that illustrated in Figures 4 to 6, the significant difference between arrangements can be seen by comparing Figure 5 to Figure 7.

In the arrangement of Figure 7, the passive electronic tag or NFC tag 300 is located on the container (or canister) 104 of the inhaler (pMDI) 100 rather than on the casing 108 or housing of the inhaler as in the arrangement of Figure 5. In particular, the NFC tag is located on the exposed outer portion of the canister that is pressed to dispense a medicament dose. This is significant because it means that the NFC tag is associated with a canister of the inhaler (that is not reusable once empty) rather the inhaler casing or housing (which is reusable). In this way, a new NFC tag is provided whenever a new canister is used.

Another difference of the arrangement of Figure 7 over that of Figures 4 to 6, is that the store or memory of the NFC tag 300 includes the dose counter rather than the separate electronic device (although the arrangement of Figures 4 to 6 could also have the dose counter located on the NFC tag rather than in the smart phone). The NFC tag obtains power through electromagnetic induction between an antenna of the NFC tag and an antenna of the electronic device communicating with it and this is sufficient for the store or memory of the NFC tag to act as a dose counter. Thus, even in this arrangement, the NFC tag does not have or require its own power supply. The counter is incremented, as described above, with reference to Figures 4 to 6 by locating the NFC tag of the inhaler near the electronic device or touching the inhaler against the electronic device. In this example, the store can store 16 bits or up to a count of 65,535 doses. The store is initialised to 0 by the manufacturer (that is, all of the 16 bits are set to 0) and this indicates a new canister or inhaler which has not provided a medicament dose.

The store of the NFC tag may store a location associated with the inhaler or canister. This may be, for example, a representation of the user's address such as their house number and postcode so that by a third party interrogating the NFC tag this information may be ascertained. In this way, if a lost inhaler or canister is found it can be returned to the user's address. Another identifier of the user could be used, such as a telephone number or e-mail address.

The location may also or alternatively include a position of registration of the inhaler or canister. That is to say, the position or location at which the inhaler or canister is first in communication connection with a separate electronic device, such as a smartphone. The location may be provided directly from the smartphone such as from its Global Positioning System (GPS) sensor. In this arrangement, it is assumed that the position or location of first use of the inhaler or canister is their home or other location where the user could be readily contacted. This is a very user-friendly feature.

The store (either in the NFC tag or smart phone) may also store a time of registration of the inhaler or canister. This time can be ascertained by the smartphone when in close proximity to the NFC tag. The smartphone can have stored on it the shelf life or usable lifetime of the inhaler or canister or alternatively this could be stored in the store of the NFC tag. Thus, by comparing the time of registration or first use of the inhaler or canister with the shelf life, the smart phone can provide an indication or warning to the user that the inhaler or canister has expired (or is close to expiry) and should not be used (or should be replaced soon).

The store (of the NFC tag or separate electronic device) may also store time and location pairs of when and where the inhaler is used. The NFC tag has capacity to store, for example, two or three time location pairs. A further alternative arrangement includes a microprocessor, located on or into the inhaler inhaler (pMDI or DPI) which may store, update and/or write on the NFC tag additional information related, among others, to localisation, time, inhalation flow of the patient during the administration for communication with a separate electronic by locating near or touching the inhaler against the separate electronic device such that communication is established.

The separate electronic device or smartphone may provide a data input means for inputting data into it associated with the inhaler in response to the NFC tag of the inhaler or canister being located near the electronic device or touching the inhaler against the electronic device. This allows a user to enter notes regarding their use of the inhaler or how they are feeling. This can be reviewed, for example, to see the effect if a user has previously missed a dose or doses. A condition management application, which is more sophisticated, may alternatively be launched by the electronic device in response to the NFC tag of the inhaler or canister being located near the electronic device or touching the inhaler against the electronic device. Such an application may ask the user particular questions about how they are feeling or use of the inhaler again so the effect of the inhaler can be ascertained. Information entered by the user may be uploaded from the electronic device to a remote computer server or servers, or cloud. This information may be used by the inhaler or canister manufacturer or research institution to monitor the efficacy of the inhaler or canister or the user's use of it. The illustrations described above have focused on the MDI as the electronically enabled inhaler. The features are equally applicable to a multidose DPI that delivers multiple single doses of a medicament from a reservoir or, in alternative, also to a single-dose DPI that delivers single doses of a medicament packaged separately. Embodiments of the present invention have been described. It will be appreciated that variations and modifications may be made to the described embodiments within the scope of the present invention.