RELEASABLE MONITOR WITH OPTICAL DOSE COUNTER FOR A MEDICAMENT INHALER

Abstract

Some embodiments are directed to a device for monitoring patient usage of a medicament inhaler, being adapted to deliver doses of medicament. The device includes a housing, for releasable attachment to the medicament inhaler, and a sensor configured to determine when a dose of medicament has been dispensed from the medicament inhaler. The device is attachable to the medicament inhaler, and is subsequently operable without any modifications being required to be made to the medicament inhaler. The device may also include an electronic control module which is in communication with the sensor, the electronic control module being adapted to monitor and/or store data relating to patient usage of the medicament inhaler.

Claims

1. A device for monitoring patient usage of a medicament inhaler, the medicament inhaler being adapted to deliver doses of medicament, the medicament inhaler including an actuator and medicament container, the device comprising: a sensor configured to determine when a dose of medicament has been dispensed from the medicament inhaler; and a housing configured to support the sensor, said housing being releasably attachable to said medicament inhaler; the housing including: a body portion, the body portion including an interior portion configured to receive the medicament inhaler, a plurality of ledge portions and at least one opening provided between the plurality of ledge portions, the plurality of ledge portions configured to engage with an underside of the actuator of the medicament inhaler when the medicament inhaler is received in the housing; and a hinged portion coupled to the body portion and movable between an open position and a closed position, in the open position the hinged portion is configured to enable the medicament inhaler to be received in or removed from the body portion and when the medicament inhaler is received in the body portion, the closed position is configured to retain the medicament inhaler in the housing: wherein the housing is configured to be coupled to said medicament inhaler, and the medicament inhaler is subsequently operable, without any modifications being required to be made to said medicament inhaler and without the device participating in the way in which the medicament inhaler moves to deliver each dose of medicament from the medicament container; and wherein the device is located outside an airflow path of the medicament inhaler and does not interfere with the airflow characteristics within the medicament inhaler; and wherein the housing is configured to be removable from the said medicament inhaler to which said housing is releasably coupled, by opening said hinged portion and sliding the said medicament inhaler out of the body portion of the housing.

2. The device according to claim 1, wherein the housing is formed of transparent material.

3. The device according to claim 1, wherein the plurality of ledge portions includes two opposing ledge portions with the at least one opening provided therebetween.

4. The device according to claim 1, wherein, in use, the plurality of ledge portions form a bearing surface for the underside of the actuator of the medicament inhaler to bear against when the actuator is actuated to deliver a dose of medicament.

5. The device according to claim 1, wherein the housing further includes a releasable latch mechanism configured to secure the hinged portion in the closed position.

6. The device according to claim 1, further comprising an electronic module supported by the housing and coupled with the sensor.

7. The device according to claim 1, wherein the sensor is an optical dose counter adapted to determine when a dose of medicament has been dispensed by transmitting an electromagnetic signal directed towards the medicament inhaler in use.

8. The device according to claim 7, wherein the optical dose counter includes: a. an electromagnetic transmitter configured to transmit an electromagnetic signal towards a portion of the medicament inhaler in use; and b. an electromagnetic receiver configured to receive the electromagnetic signal after the electromagnetic signal has engaged with the portion of the medicament inhaler in use.

9. The device according to claim 7, wherein the optical dose counter is integrated into the housing.

10. The device according to claim 7, wherein the optical dose counter is configured to determine when a dose of medicament has been dispensed by detecting a change in a characteristic of the electromagnetic signal when a moving component associated with the medicament inhaler is moved from a first position to a second position in use.

11. The device according to claim 10, wherein the moving component is located within the medicament inhaler.

12. The device according to claim 10, wherein the moving component includes at least a portion of the medicament container of the medicament inhaler.

13. The device according claim 33, wherein the characteristic is a change in the intensity of the electromagnetic signal.

14. The device according claim 10, wherein the characteristic is a change in the direction of the electromagnetic signal.

15. The device according to claim 10, wherein at least one of the first position and the second position is a rest position, the rest position being a non-dose dispensing position.

16. The device according to claim 10, wherein at least one of the first position and the second position is a dose dispensing position.

17. A method of treating a respiratory disease, comprising: a. delivering a dose of medicament to a patient using a medicament inhaler, the medicament inhaler being adapted to deliver doses of medicament to the patient, and wherein the medicament inhaler includes an actuator and medicament container; and b. monitoring patient usage of the medicament inhaler using a device for monitoring patient usage of the medicament inhaler, the device including: i. a sensor configured to determine when a dose of medicament has been dispensed from the medicament inhaler; and ii. a housing configured to support the sensor, said housing being releasably attachable to said medicament inhaler; the housing including: a body portion including an interior portion configured to receive the medicament inhaler and a plurality of ledge portions and at least one opening provided between the plurality of ledge portions, the plurality of ledge portions configured to engage with an underside of the actuator of the medicament inhaler when the medicament inhaler is received in the housing; and a hinged portion coupled to the body portion and movable between an open position and a closed position, in the open position the hinged portion is configured to enable the medicament inhaler to be received in or removed from the body portion and when the medicament inhaler is received in the body portion, the closed position is configured to retain the medicament inhaler in the housing; wherein the housing is configured to be coupled to said medicament inhaler, and the medicament inhaler is subsequently operable, without any modifications being required to be made to said medicament inhaler and without the device participating in the way in which the medicament inhaler moves to deliver each dose of medicament from the medicament container; and wherein the device is located outside an airflow path of the medicament inhaler and does not interfere with the airflow characteristics within the medicament inhaler; and wherein the housing is configured to be removable from the said medicament inhaler to which said housing is releasably coupled, by opening said hinged portion and sliding the said medicament inhaler out of the body portion of the housing.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0118] FIG. 1 is a front perspective view of one possible embodiment of the present invention,

[0119] FIG. 2 is a front perspective view of the embodiment illustrated in FIG. 1, when attached to a pMDI medicament inhaler,

[0120] FIG. 3 is a side view of the embodiment illustrated in FIG. 2,

[0121] FIG. 4 is a cut-away view of the embodiment illustrated in FIG. 3,

[0122] FIG. 5 is cut away view illustrating one possible embodiment of an optical dose counter for use with the present invention, when a medicament canister is in a rest position,

[0123] FIG. 6 is a view of the embodiment illustrated in FIG. 5, with the medicament canister in a dose dispensing position,

[0124] FIG. 7 is a rear view of a prior art medicament canister,

[0125] FIG. 8 is a rear view of the prior art medicament canister illustrated in FIG. 7, when housed within the embodiment illustrated in FIG. 1,

[0126] FIG. 9A is a perspective view of another possible embodiment of the present invention, when attached to a DPI medicament inhaler,

[0127] FIG. 9B is front view of a DPI medicament inhaler housed within the embodiment illustrated in FIG. 9A,

[0128] FIG. 9C is a perspective view of the embodiment illustrated in FIG. 9A, and

[0129] FIG. 10 is a simplified system block diagram showing one possible embodiment of an electronic control module and optical dose counter for use with the present invention.

DETAILED DESCRIPTION

[0130] Having regard to the drawings, there is shown a device, generally indicated by arrow 1, for monitoring the patient usage of a medicament inhaler, generally indicated by arrow 2 (see FIG. 2).

[0131] The device 1 includes a housing, generally indicated by arrow 3, for releasable attachment to the inhaler 2. The housing 3 is adapted to fully encircle and/or fully contain the inhaler 2.

[0132] The inhaler 2 is a pMDI inhaler which includes an actuator 4 and a medicament canister 5.

[0133] The housing 3 is comprised of an injection molded plastics material and is substantially translucent in appearance.

[0134] The housing 3 is provided with a main body portion 6 and a hinged body portion 7.

[0135] The main body portion 6 is substantially hollow and includes an interior portion 8 which is adapted to substantially match the exterior configuration of the inhaler 2, whereby the inhaler 2 may be snugly retained within the interior portion 8 of the main body portion 6. The main body portion 6 also includes lower ledge portions 9, upon which the underside 10 of the actuator 4 rests, once the inhaler 2 has been placed within the main body portion 6.

[0136] The hinged portion 7 in FIG. 1 is shown in an open position which allows the inhaler 2 to be placed into the interior portion 8 of the main body portion 6. Once the inhaler 2 has been placed in the main body portion 6, the hinged portion 7 is closed, as shown in FIG. 2. The hinged portion 7 is releasably secured to the main body portion 6 by the use of a latch (not shown).

[0137] It may be seen from the drawings that the housing 3 is releasably attachable to, or around, the inhaler 2, and subsequently operable, without any modifications being required to the inhaler 2. The inhaler 2 may be operated as normal once retained within the device 1.

[0138] Furthermore, the attaching of the housing 3 to or around the inhaler 2 does not require the use of any tools in order to be fitted; instead the inhaler 2 is simply placed within the housing 3 of the device 1.

[0139] The device 1 includes an electronic control module 11 (not physically shown, but represented in FIG. 10) housed within a side 12 of the housing 3. The electronic control module 11 is adapted to monitor and/or store data relating to patient usage of the inhaler 2.

[0140] The side 12 of the housing 3 includes a user interface, generally indicated by arrow 13. The user interface 13 allows the patient to access data recorded or received by the electronic control module, and also to change the settings of the device 1. The user interface 13 includes operational buttons 14 and a LCD display 15. One of the operational buttons 14 may be an on/off switch.

[0141] The device 1 includes an optical dose counter, generally indicated by arrow 16 (see FIG. 4). The optical dose counter 16 is housed within the housing 3, and is in electronic communication with the electronic control module 11 (see FIG. 10). The optical dose counter 16 is adapted to determine when a dose of medicament has been dispensed by the inhaler 2, by transmitting optical signals through the inhaler, 2, and from a position outside of the inhaler 2 (the operation of the optical dose counter 16 is described in more detail later).

[0142] Having regard to FIG. 4, the medicament canister 5 includes a spray stem 20, which is adapted to engage with the spray-directing element 21 formed integrally within the actuator 4.

[0143] When a patient wishes to dispense a dose of medicament, he/she places their mouth over the mouthpiece 17 of the actuator 2, and presses down on the top 18 of the medicament canister 5in the direction shown by arrow 19. This has the effect of pushing the spray stem 20 into the spray directing element 21, which releases a metered dose of medicament, and which is directed out of the mouthpiece 17 and into the mouth of the patient. The patient will generally inhale deeply at the same time that the medicament is dispensed so that the medicament is inhaled into the lungs of the patient.

[0144] FIGS. 5 and 6 show the operation of the optical dose counter 16.

[0145] FIG. 5 shows the canister 5 in the non-dispensing, or rest position, whereas FIG. 6 shows the canister 5 in the position it would be when dispensing a dose of medicament.

[0146] Having regard to FIG. 5, it may be seen that the optical dose counter 16 includes a light transmitter 22 housed within the housing 3 on one side of the actuator 4, and a light receiver 23, housed within the housing 3 on the opposite side of the actuator 4.

[0147] The light transmitter 22 is adapted to constantly transmit a beam of infrared light 24, which disperses outwardly from the point of transmission, as shown. An alternative arrangement may be to have the light transmitter 22 transmit a strobe.

[0148] The outwardly dispersing nature of the beam of light 24, occurs naturally, but this may also be accentuated by diffraction caused by the beam of light 24 passing through the outside of the actuator 4.

[0149] The light transmitter 22 may preferably transmit a continuous beam of light 24.

[0150] The light receiver 23 is constantly monitoring receipt of the beam of light 24 from the light transmitter 22. In a preferred embodiment, the light receiver may take a reading of the beam of light 24 approximately 30 times per second. Alternatively, other reading times may be utilized so long as the readings are frequent enough to detect movement of the canister 5 during the dispensing of a dose of medicamentthe movement time of the canister (or dispensing time) is typically around 100 milliseconds.

[0151] When the canister 5 is in the rest position, as shown in FIG. 5, the canister 5 remains immobile within the actuator 4. The characteristics (such as intensity and direction) of the beam of light 24, as it passes through the actuator 4, are therefore not affected in any significant way. The light receiver 23 constantly monitors this.

[0152] However, when a dose of medicament is dispensed by the canister 5, as shown in FIG. 6, the movement of the canister 5 within the actuator 4 has the effect of changing the characteristics of the beam of light 24, and this is noted by the light receiver 23and hence the optical dose counter 16 is thus able to determine that a dose has been dispensed.

[0153] The optical dose counter 16 is electronically connected to the electronic control module 11 (see FIG. 10), so that data relating to the dispensing of doses by the optical dose counter 16 may be communicated to the electronic control module 11, where it may be stored in memory, and also have other patient usage data associated with it, for example, date and time.

[0154] It may be seen from FIGS. 5 and 6 that the optical dose counter 16 is able to determine when a dose of medicament has been dispensed without impacting in any way whatsoever on the operation of the inhaler 2 or on the medicament delivery channel (namely the inside of the actuator 4 and mouthpiece 17). This is because the optical dose counter 16 is housed within, and operable from, a position outside of the actuator 4. Furthermore, the use of light to record the dispensing of a dose is non-intrusive, and does not involve or require any physical connection whatsoever with the moving parts (canister 5 and spray stem 20) within the actuator 4 during the dispensing of a dose. This is a significant advantage of the present invention over and above the prior art devices referred to previously.

[0155] The electronic control module 11 is represented in the simplified system block diagram of FIG. 10.

[0156] The electronic control module 11 includes a central processor/controller unit 25. The processor/controller unit 25 is adapted to control and manage the overall operation of the device 1, as well as being responsible for processing or performing operations on the data.

[0157] For example, the electronic control module may be able to monitor and/or record the date/time of events such as the opening and/or closing of the hinged portion 7 of the housing 3; the replacement of the battery; when any alarm notifications were made and whether the patient received them or responded to them; when a canister has been removed and/or replaced, and so on.

[0158] The electronic control module 11 is in electronic communication with the optical dose counter 16, as shown in FIG. 10.

[0159] The electronic control module 11 includes a real time clock 26, which is able to note the date and time of each dose of medicament dispensed by the inhaler 2. Furthermore, the time may be displayed on the LCD display 15, if required.

[0160] The electronic control module 11 includes a power management system 27. The power management system 27 includes a battery (not shown), and may also include warning features whereby if the battery is getting low, the patient maybe alerted to this. The battery may be a replaceable battery or a rechargeable battery.

[0161] The electronic control module 11 includes a memory 28 for storing patient usage data, or any other data relating to the use of the device 1. The memory, for example, may be RAM and/or ROM.

[0162] The electronic control module 11 includes a notification means which includes an audio/visual output 29. The audio output is in the form of a small speaker (not shown) and the visual output is in the form of a second small LCD screen (also not shown).

[0163] The audio/visual output 29 is in communication with the central processor/controller 25 and is adapted to notify the patient of a particular event. For example, audio/visual output 29 may sound an alarm to remind the patient to take a dose of medicament should it be determined that the patient has not taken a dose within a predetermined time. Likewise, the audio/visual output 29 may be adapted to alert the patient to a situation where they have taken too much of a medicament over a predetermined time period, which may be indicative of an exacerbation event. Furthermore, the notification means and audio/visual output may combine to sound alerts for any particular event, such as a dose having been recorded (a beep may sound for example), the dose counter reaching a predetermined number, and so on.

[0164] The electronic control module 11 includes a user interface 13, which includes operational buttons 14 and a LCD screen 15 (see FIG. 3). The patient may utilize the user interface to change the operational settings of the device 1.

[0165] The electronic control module 11 includes a wireless transmitter and receiver to enable the wireless transmitting and receiving of data or instructions. The wireless transmitter/receiver is an integrated component and is represented as a transceiver 30 in FIG. 10. The transceiver 30 is essentially a means to allow the device to operate interactively (ie, two-way) with any number or type of outside electronic devices, for example a cell phone (via a cell phone network) or laptops (via an internet server).

[0166] The wireless transceiver 30 is in the form of a cell phone chip (not shown) housed within the electronic control module 11 (or the housing 3). The significant cost of installing a cell phone chip is mitigated by the fact that the device 1 is reusable and has an indefinite lifetime.

[0167] The wireless transceiver 30 is able to transmit data to a third party or to another electronic device. For example, the wireless transceiver 30 may transmit patient usage data to a medical practitioner or to a parent or care giver. It may do this by transmitting the data to a cell phone network 31, and subsequently to an internet server 32 (and therefore to a mobile phone or laptop respectively).

[0168] The wireless transceiver 30 is also adapted to transmit the data in real time. Alternatively, the wireless transceiver 30 may be adapted to transmit data at a predetermined time(s), or in response to when a predetermined condition eventuates, for example if too many doses of medicament have been dispensed in a set time period indicating that an exacerbation event may be imminent. An appropriate warning may then be made to either the patient or a third party such as a parent or medial practitioner.

[0169] The transceiver 30 is also able to wirelessly receive data or instructions. For example, the transceiver 30 may be utilized to enable the patient (or perhaps a third party) to send instructions from a remote location or electronic device to change one or more of the settings of the device 1. The transceiver 30 may also be utilized to receive outside instructions to sound an alert or alarm. For example, if a third party such as a parent or medical practitioner had received data from the device 1 which indicated that a exacerbation was imminent, that third party may be able to transmit a warning to the device 1, for example by the use of a laptop or mobile phone.

[0170] The LCD screen 15 may be utilized, if required, as a dose counter display, for example for displaying the number of doses of medicament remaining in the canister 5, or alternatively for displaying the number of doses taken by the patient over a set time period.

[0171] Preferably, the dose counter display may be updated each time a dose of medicament is dispensed.

[0172] The device 1 may be used by the patient to serve as an absolute dose counter. For example, the patient may utilize the user interface 13 to choose this option and then enter the total number of doses remaining to be dispensed by the medicament canister 5with this number then being displayed by the dose display counter on the LCD screen 15. After the dispensing of each dose of medicament by the inhaler 2, the dose counter display will reduce the number of doses remaining by one.

[0173] The device 1 may also be used by the patient to serve as a non-absolute dose counter. For example, the patient may utilize the user interface 13 to choose this option and then reset the dose display counter to zero. After the dispensing of each dose of medicament by the inhaler 2, the dose counter display will increase the number of doses taken by one. Because the device is reusable across a range of medicament inhalers 2 or canisters 5, the patient may keep an ongoing total of the number of doses of medicament dispensed over a set period of time, rather than just in relation to one supply of medicament.

[0174] FIGS. 7 and 8 illustrate how the device 1 may be utilized with a prior art inhaler 37 which has a medicament canister 33 with an inbuilt mechanical dose counter. The prior art inhaler 37 is the GSK prior art device referred to previously. The canister 33 includes an absolute dose counter display 34which indicates that there are 10 doses remaining in the canister 33. The canister 33 is adapted to fit within its own dedicated actuator 35.

[0175] FIG. 8 shows the device 1 from the rear, and with the prior art inhaler 37 housed within the housing 3 of the device 1. The housing 3 is provided with a cut-away portion 36 which enables the dose counter display 34 to be viewable once the prior art inhaler 37 has been placed within the housing 3 of the device 1. An advantage associated with such an embodiment is that the prior art inhaler 37 may continue to function as an absolute dose counter with respect to the current canister of medicament 33. Furthermore, the device 1 may be utilized by the patient to act as a non-absolute dose counter (as described above), and for a length of time covering the use of many canisters 33. Hence, the patient may obtain two useful sets of dataone relating to the patient usage in relation to each canister 33 of medicament, and the second relating to general usage information over a significant (or predetermined) length of time.

[0176] FIGS. 9A-9C illustrate another embodiment of the present invention, for use with a DPI inhaler 38.

[0177] The DPI inhaler 38 is in the form of a disk which includes a store of dry powder (not shown) for the treatment of a respiratory disease such as asthma. The inhaler 38 includes a powder release lever 39 and a mouthpiece 40. As a skilled addressee would understand a portion 38a of the DPI inhaler 38 must be rotated from a closed position to an open position to reveal and provide access to the powder release lever 39 and the mouthpiece 40 by the user. In normal use, the lever 39 is moved in the direction indicated by arrow 41, and this releases a metered dose of dry powder into an internal cavity (not shown) adjacent the mouthpiece 40. The patient may then inhale the powder by sucking strongly through the mouthpiece 40.

[0178] Releasably attached to the inhaler 38 is a device, generally indicated by arrow 42, for monitoring patient usage of the inhaler 38. FIG. 9B shows the DPI inhaler in the closed position, where the mouthpiece and the lever are not accessible. To reveal the mouthpiece 40 and the lever 39, as shown in FIG. 9A, the patient moves the portion 38a of the inhaler 38 in direction indicated by arrow 141, shown in FIG. 9B.

[0179] The device 42 includes a housing 43 which is substantially U-shaped and which is designed to slide over and fit snugly around a substantial portion of the inhaler 38. The housing 43 is also provided with a hinge 46 to enable the housing 43 to hingedly open up into two halves in order to be fitted to the inhaler 38, if so desired or required.

[0180] As shown in FIGS. 9A and 9B, inhaler portion 38a is shown to indicate which part of the inhaler 38 moves relative to the inhaler mouthpiece cover to reveal the mouthpiece 40 and the lever 39. Portion 38a points to the element of the inhaler 38. Arrow 141 shows in which direction the inhaler portion 38a needs to be moved relative to the mouthpiece cover of the inhaler. FIGS. 9A-9C also show possible locations 116 of the optical dose counter on the inner surface of the device 42.

[0181] The housing 43 includes an optical dose counter (not shown) which is able to determine when a dose of medicament has been dispensed from the inhaler 38 by transmitting optical signals through the inhaler 38, and sensing movement of the internal parts of the inhaler 38 during the dispensing of a dose of powder. The optical dose counter 116 includes a light transmitter(s) (not shown) and a light receiver(s) (not shown), both housed within the housing 43. In one embodiment, the light receiver(s) may be positioned substantially opposite the light transmitter(s) in order to receive a substantially direct beam of light. In such an embodiment, the movement of part(s) within the inhaler during the dispensing of a dose may temporarily block the beam of light, thus enabling the dose counter to register that a dose of medicament has been dispensed.

[0182] In an alternative embodiment, the light transmitter(s) may transmit a normal beam of light, which will generally disperse outwardly from the point of transmission. The movement of part(s) within the inhaler during the dispensing of a dose will therefore affect the light signal, for example by the light reflecting off the part(s) as they move. This will alter the intensity of light being received by the light receiver(s), thus enabling the dose counter to register that a dose of medicament has been dispensed. In such an embodiment, it is not necessary that the moving part(s) actually block the light signal to enable a dose to be detected and/or counted. Hence, the light transmitter(s) and light receiver(s) need not necessarily be positioned substantially opposite each other. It is also possible that the light transmitter(s) and light receiver(s) could be positioned next to each other or side by side.

[0183] Having regard to FIG. 9C, alternative positions of the optical dose counter 116 are illustrated. In some embodiments, the light transmitter(s) and the light receiver(s) will be positioned substantially opposite each other. In other embodiments, the light transmitter(s) and the light receiver(s) may be positioned next to each other. The device 42 also includes a an electronic control module (not shown in FIG. 9A-9C, but also represented in the system block diagram of FIG. 10) which works substantially the same as the electronic control module associated with the pMDI inhaler 2. Furthermore, the housing 43 includes a user interface which includes an LCD screen 44 and operational buttons 45.

[0184] The device 42 only differs from the device 1 in its shape and designin order for the device 42 to be able to fit a DPI inhaler 38 as compared to a pMDI inhaler 2. The device 42 may therefore have some or all of the same features and operational capabilities as the device 1 described previously in relation to the pMDI inhaler 2. For convenience therefore, a detailed description of the workings of the device 42 is not considered necessary, and the reader is instead referred to the detailed description previously provided in relation to the workings of the device 1 for use with the pMDI inhaler 2.

[0185] An advantage associated with the device (1, 42) generally is that it may serve as both a patient compliance monitor (for example to monitor patient compliance in relation to a medicament such as a preventer or combination medicament) and also as a device to monitor patient usage of an emergency drug such as a reliever. The patient (or a third party such as a parent or medical practitioner) may therefore obtain important and useful information relating to a patient's compliance generally, as well as the ability to be forewarned of the possibility of an event such as an exacerbation event.

[0186] The invention may be particularly useful for use with large clinical trials, for example those used to determine whether a particular medicament may have unwanted side effects. Such trials may include a number of people in a trial group (those using the medicament being tested) and a number of people in the control group (those not using the medicament being tested). There may be upwards of 3000 people in each group, and the results of the clinical trial may be very important. Hence, it is imperative that the people running the trial know for certain whether the trial group and/or control group has been taking the medicament as prescribed, and over the set time period of the trial (which may be many months). Because the present invention is reusable in relation to each new container of medicament being tested, it may be used by each patient in the trial, for the entire duration of the trial.

[0187] The invention may also be useful as a diagnostic tool by a respiratory specialist for use with their patients. For example, a specialist may be unsure whether a patient has asthma or heart disease. The specialist may therefore supply the device to a patient for use with asthma medicament over a period of time and the usage information being used by the specialist to diagnose the disease. Moreover, the patient may return the device to the specialist at the conclusion of the trial, whereby it may be supplied the next patient of the specialist.

[0188] The invention may also be useful as a self-diagnosis device for a patient. That is, a patient may use the device to self-monitor their own personal usage and make conclusions or changes as a result. Alternatively, it may be used by a parent or care giver as a tool for ascertaining if someone in their care has been taking their medicament correctly, or otherwise.

[0189] This may be of particular advantage during clinical trials where the ongoing monitoring of a patient is being undertaken over a considerable time period, and perhaps whereby the patient changes medication half way through the trial.

[0190] While the embodiments described above are currently preferred, it will be appreciated that a wide range of other variations might also be made within the general spirit and scope of the invention and/or as defined by the appended claims.