EP3193990A1

EP3193990A1 - Adherence monitor for a dry powder medicament delivery device

Info

Publication number: EP3193990A1
Application number: EP15791793.1A
Authority: EP
Inventors: Garth Campbell Sutherland
Original assignee: Adherium NZ Ltd
Current assignee: Adherium NZ Ltd
Priority date: 2014-09-15
Filing date: 2015-09-15
Publication date: 2017-07-26
Also published as: AU2015318726A1; JP2017527415A; WO2016043601A1; CN106999682A

Abstract

An adherence monitor for a dry medicament dispenser having a rotatable base. The monitor has an opening including internal resilient projections, so that the base can be received and retained in the opening, and the base can be rotated by rotating the monitor. Also disclosed is a cap detection sensor for use with a monitor or in the dispenser, including a lever extending generally parallel to the axis of rotation of the base, the lever at one end extending past the base towards the cap, and extending into the dispenser or monitor so as to engage a switch, the arrangement being such that the lever is engaged by the cap as it is attached, and thereby enables the switch.

Description

ADHERENCE MONITOR FOR A DRY POWDER MEDICAMENT DELIVERY DEVICE

Technical Field

[0001 ] The present invention relates to methods, devices and systems for monitoring adherence to medication regimes for dry powder medicaments.

Background of the Invention

[0002] The invention is concerned with adherence monitors for dry powder inhalers. These are often used in the treatment of respiratory diseases such as asthma, COPD, cystic fibrosis, and bronchiectasis. However, such devices may also be used to deliver other medications, for example for the treatment of pain, heart conditions, erectile dysfunction, diabetes, and other indications.

[0003] There are several different types of dry powder inhalers in commercial use. One type is in the form of a disk, which includes an external lever. The lever may be actuated by a user to deposit a dose of medicament into an inhalation chamber, after which it may be inhaled by the user via a mouthpiece.

[0004] Another common type of dry powder inhaler is in the form of a generally tube- shaped body, which includes an internal store of a suitable medicament; a rotatable base for dispensing a single dose of the medicament into an appropriate inhalation chamber; and a mouthpiece, through which a user may inhale the medicament that has been dispensed into the inhalation chamber. Such dry powder inhalers usually come with a removable and replaceable cap, adapted to cover the mouthpiece and tube-shaped body of the inhaler when the inhaler is not in use.

[0005] An example of such a dry powder inhaler is the TURBUHALER^® which is manufactured and marketed by AstraZeneca AB. Another example is TWISTHALER^®, and is manufactured and marketed by Merck & Co. The TWISTHALER^® is similar to the TURBUHALER^®, except that the TWISTHALER^® dispenses a dose of medicament when the cap is unscrewed from the tube-shaped body. That is, the unscrewing of the cap from the tube-shaped body portion serves to automatically rotate the tube-shaped body with respect to the base portion, and it is this action which dispenses a dose of medicament into the inhalation chamber.

[0006] A problem associated with the use of all medicament inhalers is poor adherence. Many studies have shown that users frequently do not take their medicament at the predetermined or prescribed times and/or in the required amounts. The consequences of this non-adherence can include reduced disease control, lower quality of life, lost productivity, hospitalisation and avoidable deaths. This represents a considerable cost to the users, as well as to the health system.

[0007] Adherence monitoring devices have been developed for use with medicament inhalers, principally for use with pressurized metered dose inhalers, rather than dry powder inhalers. The mechanical structures required for pressurized metered dose inhalers differ significantly from those required for dry powder inhalers.

[0008] NZ Patent No. 614928 by the present applicant discloses a compliance monitor for dry powder inhalers, formed form two portions, which are screwed together on the inhaler. Screwing the two portions of the adherence monitor together can be a fiddly and time consuming process. In some cases the portion may be cross threaded, resulting in the two portions not being properly secured, or with the compliance monitor not working correctly, or not at all.

[0009] Further, the action of screwing or unscrewing the two portions of the adherence monitor with respect to each other can sometimes inadvertently rotate the rotatable base of the inhaler at the same time, to thus release (or "half release") a dose of medicament into the inhalation chamber.

[0010] The applicant's NZ Patent No. 622000 describes a two part, push-fit compliance monitor for dry powder inhalers. Whilst avoiding the complexities of screw fitting, this still requires the user to assemble a monitor around an inhaler.

[001 1 ] Another issue relates to the correct use of the cap by the user. It is important that the cap be replaced when it is not in use, to ensure that dust and moisture do not contaminate the medication. Further, it is clinically useful to understand the behavior of users with the inhaler. Some patient repetitively play with their inhalers, putting the cap on and taking it off. Others may not be paying attention, open the inhaler, become distracted, and replace the cap without taking the medication.

[0012] The ability to record adherence data, including when the cap is removed and replaced would be very useful and important information, both for training purposes or feedback for the user, as well as for general medicament compliance data gathering purposes.

[0013] US Patent Publication No. 2004/0187869 (Bjorndal et al) describes a training device for a dry powder inhaler, which prevents the device operating if the cap is still on. It does not however collect adherence data. [0014] US Patent Publication No. 201 1/0226242 (Von Hollen et al) describes an inhaler which is adapted to emit an audible instruction (and/or provide audible usage feedback) upon the cap being removed. However, Von Hollen does not allow for compliance data to be gathered relating to how many times the user attempts to use the inhaler with the cap on and/or when, and how often, the cap is removed and/or closed.

It is an object of the present invention to provide an effective adherence monitor which can be easily and reliably fitted to a dry medicament inhaler.

Summary of the Invention

[0015] In a first broad form, the present invention provides an adherence monitor for a dry medicament dispenser with a rotatable base, the adherence monitor including an opening with internal resilient projections, arranged so that the base can be received and retained in the opening, and operatively rotated by rotating the monitor.

[0016] According to one aspect, the present invention provides adherence monitor for a dry medicament dispenser, the dispenser having a rotatable base, the adherence monitor including a body having an opening therein, the opening including internal resilient projections, arranged so that operatively the base can be received and retained in the opening, and the base can be rotated by rotating the monitor.

[0017] According to another aspect, the present invention provides an adherence monitor for a dry medicament dispenser, the dispenser including a rotatable base, a mouthpiece, and a removable cap for the mouthpiece, the adherence monitor including an opening for operatively receiving the base of said dispenser, and a cap detection sensor for detecting the removal or engagement of the cap, the sensor including a lever extending generally parallel to the axis of rotation of the base, the lever at one end extending past the base towards the cap, and extending into the monitor so as to engage a switch, the arrangement being such that the lever is operatively engaged by the cap as it is attached, and thereby changes the state of the switch.

[0018] According to a further aspect, the present invention provides an adherence monitor including a dose detection sensor and a cap detection sensor, wherein the adherence monitor further includes a dose detection mechanism, and the dose detection mechanism is disabled until the cap detection sensor detects that the cap is removed.

[0019] According to another aspect, the present invention provides a method of retaining a dry medicament dispenser in an adherence device, the method including: providing a recess in the adherence device, the recess including resilient projections, inserting the rotatable base of the adherence device within the recess, the insertion compressing the resilient projections, so as to retain the base of the dispenser within the adherence device, and so that rotation of the adherence device also rotates the rotatable base.

[0020] According to another aspect, the present invention provides a cap detection sensor for a dry medicament dispenser, the dispenser including a rotatable base, a mouthpiece, and a removable cap for the mouthpiece, the sensor including a lever extending generally parallel to the axis of rotation of the base, the lever at one end extending past the base towards the cap, and extending into the dispenser so as to engage a switch, the arrangement being such that the lever is operatively engaged by the cap as it is attached, and thereby changes the state of the switch.

[0021 ] It can therefore be seen that implementations of the present invention provide an adherence monitor that can be fitted without the need for assembly or screw fitting by the user.

[0022] Further, implementations of the present invention allow for an effective cap detection system which can be employed with a push fit or similar attachment.

Brief Description of the Drawings

[0023] An illustrative embodiment of the present invention will be described with reference to the accompanying figures, in which:

[0024] Figure 1 A and 1 B are perspective views of a first embodiment of an adherence monitor for monitoring according to the present invention;

[0025] Figure 2 is a partially exploded view of the embodiment illustrated in Figs 1 A and 1 B, showing how the adherence monitor is fitted to a medicament delivery device;

[0026] Figure 3 is a view of the embodiment illustrated in Fig 2, with a cap fitted to the medicament delivery device;

[0027] Figure 4 is a plan view of a second embodiment of the present invention;

[0028] Figures 5A and 5B is a perspective views of a third embodiment of an adherence monitor; [0029] Figure 6A is an inverted exploded view of an embodiment of the adherence monitor, showing angled views of each component of the adherence monitor;

[0030] Figure 6B is an upright exploded view of the embodiment illustrated in Fig 6A;

[0031 ] Figure 7 A and 7B are cross sectional views illustrating the operation of the cap detection sensor in disengaged and engaged states respectively;

[0032] Figure 8 is a perspective view of a fourth embodiment of the present invention; and

[0033] Figure 9 is a flow chart of the processing steps of an algorithm employed to detect cap state change events and activate dose detection mechanism.

Detailed Description of the Invention

[0034] Throughout this specification, the terms "patient" or "user" or "person" or "patient usage", when used in relation to the use of a medicament delivery device, are to be understood to refer to any person that uses a medicament delivery device.

[0035] The present invention will be described in relation to various specific implementations, which it will be understood are intended to be illustrative and not limitative of the scope of the present invention. It will be appreciated in particular that various additional features and functions, indicators and the like may be included in monitors which implement the present invention. These may be selected for specific application at the option of the product designer.

[0036] The following implementations will be described with reference primarily to the TURBUHALER^® and TWISTHALER^® products, as these are in widespread commercial use. However, the present invention may, with suitable modifications as will be apparent to those skilled in the art, be applied to other designs of dry powder medicament dispensing devices, present or yet to be developed.

[0037] Similarly, whilst the discussion below is principally in relation to respiratory related medicaments, it is applicable to any use of dry powder medicament dispensing devices, including by way of example only pain medication, diabetes, erectile dysfunction, or other conditions. The present invention is concerned with the monitoring of how the medication is used and dispensed, and should in no way be considered as limited to any particular medicament or condition. [0038] As a general explanation, the implementations described are intended to be attached by a user to a dry powder medicament dispensing device. They include systems to detect that a dose has been dispensed, and retain or communicate a record of this to a remote system, for example via Bluetooth® to a smartphone, tablet or other device. The intention is to automatically create a record of usage, to assist in clinical management. They may also provide reminders to the user, detect whether or not a dispensing device is attached, provide error indications, or provide other functions.

[0039] Referring to figures 1 A, 1 B, 2 and 3 there is shown an adherence monitor 1 used for monitoring patient usage of a dry powder inhaler, generally indicated by arrow 2. The dry powder inhaler 2 illustrated is a TURBUHALER^®, which is manufactured and marketed by AstraZeneca AB. For further information about TURBUHALER^®, the reader is referred to the material made available by AstraZeneca AB at

[0040] The inhaler 2 includes a store of medicament (not shown) which is housed within a main body portion 3. The inhaler 2 also includes a rotatable base 4, which is rotatable with respect to the main body portion 3. The inhaler 2 has a mouthpiece 5, through which a dose of medicament may be inhaled by a user. Also included is a removable and replaceable cap 6. Inhaler 2 also includes a medicament dispensing means (not shown) for dispensing a dose of the medicament into an inhalation chamber (not shown).

[0041 ] The store of medicament is in the form of a single and solid mass, housed within the main body portion 3, and the rotating of the rotatable base 4 with respect to the main body portion 3 causes internal scrapers (not shown) to scrape a small amount of medicament from off the single mass, after which the removed medicament is directed into the inhalation chamber - in the form of a metered amount of dry powder. The dry powder is then inhaled by the user who sucks strongly on the mouthpiece 5.

[0042] The internal workings of the inhaler 2 (not shown) are usually configured to create an enhanced internal airflow when the user is sucking on the mouthpiece 5. This draws the dry powder medicament out through the mouthpiece 5, and into the mouth of the user. The intention is to ensure that a maximum amount of the dry powder medicament reaches, and/or is deposited in, the airways and/or lungs of the user.

[0043] The adherence monitor 1 includes a recess 35 in which rotor 7 is disposed. The inner surface 9 of rotor 7 projects into the open centre of rotor 7, and a is shaped to include projections 10 so as to be complementary to the external grip surface 8 on the outer side of the rotatable base 4 of inhaler 1 . The inner surface 9 is coated, for example by an overmoulding process, in a resilient, rubber material. For example, the projections may be manufactured in a dual stage injection mould where the rigid part is moulded first and then inserted into a second injection tool to allow for the soft projections to be moulded. This provides a set of shaped internal resilient projections 10 which extend from inner surface 9 into the centre of rotor 7. In the form illustrated, projections 10 reformed as a sets of teeth, however, other shapes and configurations may be used consistent with the grip surfaces 8 and the nature of the particular inhaler with which it is intended that the adherence monitor be used.

An alternative method generating the internal resilient projections is to mould them as a separate part which is then clipped onto corresponding openings in inner surface 9 of rotor 7 or bonded into place.

[0044] The rubber material may be a synthetic rubber material. For example the rigid part may be manufactured using an Acetal or Nylon type material and the soft teeth could be a TPU, silicon or natural rubber compound, preferably with a shore hardness between 40 and 90 shore A. The preferred shore hardness will depend on the final size and shape of the protrusions (a larger cross section requires a softer material to gain the same compression).

[0045] To place monitor 1 and inhaler 2 into an operative state, the rotatable base 4 of the inhaler 2 is pushed into the centre of rotor 7 within recess 35 of adherence monitor 1 . The external grip surface 8 is oriented to align with projections 10. The shaped projections 10 will be compressed, so as to provide an effective interference fit. However, the fit is releasable with the application of suitable force, so that the monitor may be readily moved, for example, to a new inhaler when the original inhaler 1 is empty.

[0046] To remove the adherence monitor 1 from the inhaler 2, the patient first removes the cap 6 from the inhaler 2 and holding the mouthpiece with one hand, slowly pulls the adherence monitor 1 off the rotatable base 4 with the other hand.

[0047] Once the monitor 1 and inhaler 2 are attached, subsequent rotation of the adherence monitor 1 also causes rotation of the rotatable base 4, as required for the discharge of medication by the inhaler. That is, the adherence monitor 1 act effectively as an outer rotation grip for the inhaler base 4.

[0048] In some embodiments the projections 10 may be spaced evenly along the inner surface 9 of the rotor 7. In another embodiment, the projections 10 may be grouped into two sets located opposite each other on the inner surface 9. Figure 4 illustrates an alternative embodiment of the adherence monitor 1 of this invention, wherein there are three sets of projections 10, spaced evenly along the inner surface 9 of the rotor 7. It will be appreciated that other configurations may be used. Further, the shape and size of the projections may be varied and selected for a particular design, consistent with the mechanical requirements of the interface with the grip surface 8 of inhaler 2. [0049] Referring to figures 2 and 3, the interior surface of cap 6 is provided with a first threaded portion 14 (shown as a dotted line, as not visible from this angle), and the outside of the main body portion 3 is provided with a complimentary second threaded portion 15, whereby the cap 6 may be attached to the inhaler 2 by placing it over the main body portion 3, and screwing the two threads 14, 15 together. Likewise, the cap 6 may be removed from the inhaler 2 by unscrewing the threads 14, 15 from each other, and subsequently removing the cap 6.

[0050] Despite the adherence monitor being formed as a device which attaches only to the base, there is still a need for a cap detection sensor. WO 2015030610 by the present applicant discloses a cap detection device suitable for a two part inhaler. However, for the present application, an alternative mechanism has been developed.

[0051 ] Figure 1 shows a protrusion 12 extending out from monitor 1 , with a lever 13 inside. It can be seen that lever 13 is located so that it projects into the space that is occupied by cap 6 when monitor 1 is attached to inhaler 2.

[0052] The action of screwing cap 6 to the main body portion 3 causes cap 6, when it reaches the appropriate degree of travel along the thread 15, to applying pressure to lever 13. This pressure causes the lever 13 to pivot and engage a cap detection switch 21 (Fig 6B). The cap detection switch 21 is therefore closed and the cap 6 is thus detected as being attached to main body portion 3 of the inhaler 2.

[0053] Likewise, the removal of the cap 6, by unscrewing the cap 6 with respect to the main body portion 3, has the effect of releasing the pressure of the cap 6 from the lever 13. The lever 13 then pivots away from the cap detect switch 21 . The switch 21 is therefore opened and the removal of cap 6 from the main body portion 3 is detected.

[0054] Figures 7 A and 7B illustrate the operation of the cap detection sensor in more detail. In figure 7A, it can be seen that lever 13 has a lug 30 on the outer end, to assist in engaging cap 6. Lever 13 is biased so as to adopt the attitude with lug 30 urged into the centre of housing 29, in the absence of a cap. At the other end 31 of lever 13, end 31 is urged outwardly, and therefore out of contact with switch 21 . This represents the ordinary state of monitor 1 and lever 13, in the absence of cap 6.

[0055] Figure 7B shows the situation when cap 6 is attached. For clarity, cap 6 is not shown, but can be assumed to be present and screwed into the attached position. Cap 6 6 forces lug 30 back, pivoting lever 13, so that inner end 31 is moved inwardly. This causes lever 31 to engage switch 21 , and indicate that cap 6 is attached. [0056] It will be appreciated that the cap detection system may also be applied to other types of adherence monitors, including those which have a two part or multi-component assembly, in addition to its utility in relation to a push fit or similarly attached device. For example, it could be used with device which attach with a squeeze fit, bayonet style rotational locking fit, or other such devices.

[0057] Once the adherence monitor 1 has been fitted to the inhaler 2, a dose of medicament may be dispensed as follows. Cap 6 is unscrewed from the main body portion 3 of the inhaler 1 , and this action is detected by the cap detection mechanism, as described previously.

[0058] The adherence monitor 1 is then rotated back and forth once with respect to the main body portion 3, which has the effect of rotating the rotatable base 4 back and forth once with respect to the main body portion 3. As described previously, this results in a metered dose of dry powder medicament being placed within the inhalation chamber, from where it may be inhaled by a user - by the user sucking strongly on the mouthpiece 5. The cap 6 may then be screwed back onto the main body portion 3 of the inhaler 2 - and again this action is detected by the cap detection mechanism, as described previously.

[0059] Figs 5A and 5B show a further embodiment of adherence monitor 1 of the present invention, wherein adherence monitor 1 does not include the cap detection mechanism.

[0060] The adherence monitor 1 accordingly to implementations of the invention also includes dose detection means for determining if a dose of medicament has been dispensed, and/or if the rotatable base 4 has been rotated with respect to the main body portion 3 in a way which is required to dispense a dose of medication.

[0061 ] The dose detection means according to this implementation comprises a calibrated torque detection system, embedded within adherence monitor 1 .

[0062] When rotatable base 4 is rotated in relation to the body portion 3 of the inhaler 2 with sufficient torque, the torque detection system actuates an electromechanical switch. The On' signal is then recorded by the ECM (described below). Rotation of the rotatable base 4 in the opposite direction (until a click is heard) also requires a specific minimum torque. If that correct level of torque for the specific device is used, then the torque detection system actuates an electromechanical switch and, again, the On' signal is recorded by the ECM.

[0063] The ECM may, for example and without limiting other methods, be calibrated to: (a) confirm and log that a dose was correctly dispensed if both On' signals are detected; (b) confirm and log that a dose was incorrectly dispensed if the second On' signal is not detected:

(c) measure the time delay between the first switch actuation and the second actuation and if the delay between them exceeds a pre-set value, confirm and log that the dose was incorrectly dispensed, and/or

(d) detect and time-out occurrences where the device is jammed in one position.

[0064] In one embodiment, the dose detection means is provided by leaf springs 16, 16' (Figure 6A) housed within the housing 17 of the adherence monitor 1 . The pressure of rotating the adherence monitor 1 with respect to the main body portion 3 (to thereby rotate the rotatable base 4 with respect to the main body portion 3) results in the leaf springs 16 and or 16' actuating the dose detect switch 22.

[0065] Referring to figure 6A and 6B, the adherence monitor 1 consists of the housing 17, the base 18, the circuit board 19, and the leaf springs 16 and 16' held within the housing 17. Rotor 7 is attached to housing 17 in a way which allows rotor 7 to rotate either way in relation to housing 17. The protrusions 20 and 20' located on the base of the rotor 7 are positioned so that in a 'rest' position they abut the leaf springs 16 and 16'. When the adherence monitor 1 and the rotatable base 4 are turned one way in relation to the main body portion 3 to the point of resistance, the resistance of the rotatable base 4 causes the rotor 7 to move separately from the rest of the adherence monitor 1 . The protrusions 20 or 20' (depending on the direction of the turn) push the leaf spring 16 or 16' respectively. When the force with which the leaf springs 16 or 16' are pushed exceeds the pre-set torque level, the rotor 7 turns in relation to housing 17 and the leaf springs bend. The movement of the rotor 7 causes the leaf springs 16, 16' to engage the dose detect switch 22 on the circuit board 19. Each leaf spring 16, 16' may have its own switch or a two-way directional switch may be placed between the leaf springs.

[0066] In an alternative embodiment, additional protrusions on the base of the rotor 7 may engage the dose detect switch 22 on the circuit board 19. Other positions of the dose detect switch 22 on the circuit board 19 and other methods of activating the dose detect switch 22 via the movement of the rotor 7 are also possible. The leaf springs 16, 16' may be adjusted so that the torque required to engage the dose detect switch 22 differs, depending on the torque required to dispense a dose of the medicament from the inhaler 2.

[0067] In other embodiments of the dose detection means, other spring systems could be used, for example, the dose detection arrangements disclosed in the various references incorporated herein by reference.

[0068] In another embodiment, the spring system may consist of one leaf spring positioned on the side nearest the rotation required to dispense the medicament. One leaf spring based torque system may include one or more protrusions required to detect rotation either one way or both ways.

[0069] In one embodiment, the dose detection means may be set up so as to only record a dose as having been dispensed when the adherence monitor 1 (and therefore rotatable base 4) has been rotated back and forth once with respect to the main body portion 3 (which is the usual way of dispensing a dose for the TURBUHALER^® device illustrated). Hence, the dose detection means serves to detect and/or record every time a dose of medicament has been dispensed.

[0070] Additionally, the dose detection means may be set up so as to also detect and/or record when the adherence monitor 1 (and therefore rotatable base 4) has only been rotated once, and in one direction, with respect to the main body portion 3. Many users inadvertently or erroneously believe that a dose of medicament has been dispensed by such an action, whereas a dose will only be dispensed once this action has been completed twice (that is, forward and then back). Hence, and in such an embodiment, the dose detection means can determine incorrect usage of the inhaler 2 by a user, that is, an incorrect technique for dispensing a dose of medicament.

[0071 ] Additionally, the dose detection means may also be set up so as to detect and/or record each time that an attempt is made to rotate the adherence monitor 1 (and therefore the rotatable base 4) with respect to the main body portion 3, when the cap 6 is still attached (as detected or recorded by the cap detection mechanism). It is not possible to dispense a dose of medicament with the cap 6 still attached. However, a user may nonetheless erroneously believe that they have dispensed a dose of medicament, and they may subsequently remove the cap 6 and suck on the mouthpiece 5, believing that they have received a dose of medicament. Hence, the dose detection means serves to detect and/or record such erroneous techniques. For example, such erroneous use of the inhaler 1 may be detected by the adherence monitor 1 including an electronic pressure switch, which may closed when a sufficient and predetermined rotational pressure is applied to it (even if the rotation of the rotatable base 4 is not actually permitted, for example because the cap 6 is still attached).

[0072] Furthermore, the dose detection means and/or the cap detection may be adapted, or able, to differentiate between when a user dispenses a dose of medicament normally, as compared to when a dose of medicament is inadvertently dispensed when the cap is being removed or replaced. This may be achieved, for example, by determining that the timing of the dispensing of a dose of medicament was at substantially the same time as the cap being removed or replaced. [0073] In a preferred form, the dose detection mechanism may be disabled for recording a dose until the cap detection system determines that the cap has been removed. This minimises the risk of false dose detection.

[0074] Figure 9 illustrates one example of an algorithm employed to activate the dose detection mechanism in response to cap state change. A state change of the cap detect switch 21 causes the electronics control module (ECM or processor) to commence running the algorithm. In response to the cap state change signal at step 101 , the ECM checks if the cap status is ON at step 102. If the cap 6 is on the mouthpiece 5, the algorithm disables the dose detection mechanism (i.e. rotation sensor) at step 103 and checks for inhaler in/out status at step 104. If no inhaler is detected at step 105, the algorithm is completed and no logs are entered into the adherence monitor memory- no inhaler is attached to the adherence monitor - and no dose detection mechanism activation occurs. If, at step 105, the inhaler is installed in the adherence monitor 1 , the ECM checks, at step 106, if the previous cap log stored in the memory was a CAP ON log. If the previous cap log is not a CAP ON log, the ECM stores a CAP ON log in the adherence monitor memory 107. Where the previous log was a CAP ON log, another inhaler in/out check is performed at step 108, until timeout occurs. In both those instances, cap 6 remains on and the dose detection mechanism is not activated. If the algorithm establishes, at step 102, that cap 6 is off, an inhaler status check is performed at step 109. If no inhaler is detected at step 109, the dose detection mechanism is not activated and another inhaler in/out check is performed at step 1 10, until timeout. If inhaler is in, the algorithm establishes if the previous cap log in the memory was a CAP OFF. No log is generated, if the previous log is a CAP OFF log and the dose detection mechanism is not enabled. If the previous log was a CAP ON log, the ECM stores a CAP OFF log in the adherence monitor memory at step 1 12 and at step 1 13 the ECM enables the dose detection mechanism (i.e. rotation sensor).

[0075] Once the dose detection mechanism is enabled, certain pre-set rotation sequences will be logged as medication events while other may be logged as respective rotations only. For example, an anticlockwise rotation of the grip base in relation to the inhaler body, followed by a clockwise rotation within 60s of the first anticlockwise rotation will result in a medication log being entered into the adherence monitor memory and further in a transmission of the medication event log to a paired smartphone and/or the web server.

[0076] The adherence monitor 1 may further be adapted to detect the absence or presence of the medicament delivery device. The device detection means may include an optical device recognition and detection means as described in our patent application NZ 625105, the content of which is incorporated herein by reference. [0077] Having regard to Figs 1 A and 1 B, and Figs 6A and 6B, a device detection means 1 1 may be embedded into the housing 29 of the adherence monitor 1 , under the opening 23 within the rotor 7.

[0078] Adherence monitor 1 includes an ECM (general position indicated by arrow 37), with the ECM being adapted to monitor and/or manipulate and/or store and/or transmit all adherence data gathered, relating to the patient usage of the medicament delivery device. The ECM may be a suitable microprocessor device.

[0079] The use of ECM's, in conjunction with adherence monitors for medicament delivery devices, are well known, and it is not intended therefore to describe them in any significant detail herein. For example, these systems are in general terms in commercial use in products available from the present applicant and related companies, as well as disclosed in the applicant's prior patent filings, for example those incorporated by reference herein. An example of an adherence monitor, used in conjunction with an ECM and/or transmitter can be found in our US Patent No. 8424517 and our US Patent Publication No. 2014/0000598.

[0080] Referring to figures 6A and 6B adherence monitor 1 and the ECM are powered by a battery 24, and either a rechargeable or replaceable battery may be used. The ECM and/or the adherence monitor may be alternatively be powered by any suitable alternative means, for example a kinetic charger, or by solar power.

[0081 ] The ECM stores and transmits the adherence data gathered, so that analysis can determine if the user has used the inhaler correctly and/or incorrectly. The inhaler use logs generated in the adherence monitor are uploaded into smartphone application, a PC or a central communication hub, and through those into a web based server. In some embodiments, the inhaler use logs may also be uploaded from the adherence monitor directly into a web based server.

[0082] Adherence monitor 1 includes a memory. In some embodiments, a volatile type computer memory, including for example RAM, DRAM, SRAM, may be used. In such instances, the adherence monitor may continually transmit information to the computing device external to the adherence monitor or medicament delivery device. In other embodiments non-volatile memory formats may be used, including for example ROM, EEPROM, flash memory, ferroelectric RAM (F-RAM), optical and magnetic computer memory storage devices, and others.

[0083] The adherence monitor 1 also includes indication means, such as LED 25 to indicate an event and/or to alert the user if the ECM determines that the user has used the inhaler correctly and/or incorrectly. For example, the indication means may be utilised to alert the user if they have only rotated adherence monitor 1 (and therefore the rotatable base 4) once, and in one direction. The indication means may be utilised to alert the user if they have attempted to dispense a dose of medicament with the cap 6 still attached. Alternatively, the indication means may be used to alert if medication has not been dispensed within certain timeframe, e.g. every 12h or 24h.

[0084] The indication means may be in the form of one or more LEDs as illustrated, or in the form of some other visual and/or audio and/or vibrational indicator. Adherence monitor 1 also includes a multi-function user button 26 for monitoring and controlling several aspects of operation. For example, pushing the button once may result in a green light showing if the adherence monitor 1 is fitted to the inhaler 2 correctly, and in normal working order. Conversely, a red light may indicate a problem. Pushing the button twice may provide for another aspect of the adherence monitor to be checked or reported, and furthermore pushing and holding the button may result in yet another function or check being done.

[0085] The adherence monitor 1 may also include user interface enabling the user to access data recorded or received by the adherence monitor and also change the settings of the adherence monitor (for example, date/time, visual/audio alert settings). The user interface may also be used to access any data received (or transmitted) by the adherence monitor or to control the upload of the data from the adherence monitor to an external electronic device.

[0086] The embodiments of the adherence monitor 1 and/or the ECM described herein may be able to monitor for any type of non-dose counting information relating to the operation of the inhaler 2, and/or patient usage of the inhaler 2. For example, the ECM may include a real time clock (or be in electronic communication with one) to enable the adherence monitor 1 to record a date and time for each dose of medicament dispensed. The ECM may be calibrated to compare the actual doses dispensed against the table of pre-set dosage times and, if the dose is not dispensed at the pre-set time, alert the user that a dose is due.

[0087] Furthermore, and for example only, adherence monitor 1 and/or the ECM may also be able to monitor criteria such as geographical location, temperature, humidity, the orientation of the inhaler 2, the condition of the medicament, the amount of medicament left, the condition of the battery or whether it is installed, the flow or pressure of the user's inhalation, an audio sensor for detecting inhalation or for determining if the main body portion has been rotated with respect to the base portion, and so on. To this effect, the ECM may include an audio or optical inhalation sensor, thermistor sensor or accelerometer, or be connected to a GPS (e.g. the adherence data from the smartphone paired with the adherence monitor 1 may be matched with the GPS data relating to the location of adherence events received by the smartphone). [0088] Adherence monitor 1 may also include a communication device for transmitting the adherence data. In one embodiment, this may be a USB port 27 located on the housing 17 of the adherence monitor 1 . Any other suitable wired connections or ports may be used.

[0089] Alternatively and/or additionally, the adherence monitor 1 and/or ECM may be provided with a wireless transmitter and/or a wireless transceiver e.g. Bluetooth Low Energy® module 28 to be able to transmit and/or receive data respectively. Any other suitable wireless technology known in the art may be used, including for example Wi-Fi (IEEE 802.1 1 ), Bluetooth®, other radio frequencies, Infra-Red (IR), GSM, CDMA, GPRS, 3G, 4G, W-CDMA, EDGE or DCDMA200 or similar.

[0090] The data may be transmitted to a remote computer server or to an adjacent electronic device such as a smart phone or electronic tablet. The adherence monitor may be paired with a smartphone loaded with a software application which allows the smartphone to access, process, and/or present the data collected by the adherence monitor. The smartphone may be configured to transfer the data obtained from the adherence monitor to a web services platform. The data may be transmitted in real time, manually or at predetermined set times.

[0091 ] Having regard to figure 8, an alternative embodiment of the adherence monitor of the present invention is shown. The adherence monitor 51 includes an alarm function 32. The alarm switch allows the user to choose between 12h, 24h or no alarm option. When the ECM detects a medication log, the real time clock is reset and if no subsequent medication log occurs within the present timeframe (12 or 24 h), the ECM causes the indication means to sound an alarm.

[0092] 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.

[0093] For example, the cap detection mechanism may be in the form of an electromechanical, optical or pressure switch which is actuated, and de-actuated, when the cap is attached to, and removed from, the medicament delivery device, respectively. The engagement aspect of the present invention is not limited to the specific cap detection system disclosed.

[0094] Preferably, the ECM may utilise the adherence data gathered to determine if the user has used the medicament delivery device correctly and/or incorrectly. This may be achieved by incorporating an appropriate algorithm(s) within the ECM or other user devices, for example a tablet or smartphone, or a remote system, to analyse the adherence data gathered and/or to draw an appropriate conclusion.

[0095] Further, the cap detection mechanism of the present invention may be embedded directly in an electronically enabled medicament dispenser, rendering the use of separate adherence monitor unnecessary. It will be appreciated that the lever mechanism would need to be disposed within or along the thread of the dispenser, with provision for the processor, switch, etc. in the dispenser.

[0096] For example a rotatable base of the inhaler may be modified to include a circuit board, an ECM, a memory, user interface, a battery, a dose detection mechanism and the cap detection mechanism of the present invention. The rotatable base of the inhaler could be modified to include the cap detection sensor. This could be achieved by including a lever extending at one end past the rotatable base of the inhaler towards the cap, and, at the other end, extending into the rotatable base so as to engage a cap detection switch embedded in the rotatable base. The lever may be positioned so that it is operatively engaged by the cap as it is attached, and thereby changes the state of the cap detect switch. Alternatively, another form of cap detect sensor could be embedded in the rotatable base.

[0097] The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates.

[0098] All patent and other references noted in the specification, including websites, are hereby incorporated by reference.

Claims

1 . An adherence monitor for a dry medicament dispenser, the dispenser having a rotatable base, the adherence monitor including a body having an opening therein, the opening including internal resilient projections, arranged so that operatively the base can be received and retained in the opening, and the base can be rotated by rotating the monitor.

2. An adherence monitor according to claim 1 , wherein the monitor has a body formed from a first polymer material, and the resilient projections are formed within the opening as an overmould of a second polymer material, the second material being more compliant than the first polymer material.

3. An adherence monitor according to any one of the preceding claims, wherein the base is retained in the opening by compressing the projections, so as to form an interference fit.

4. An adherence monitor for a dry medicament dispenser, the dispenser including a rotatable base, a mouthpiece, and a removable cap for the mouthpiece, the adherence monitor including an opening for operatively receiving the base of said dispenser, and a cap detection sensor for detecting the removal or engagement of the cap, the sensor including a lever extending generally parallel to the axis of rotation of the base, the lever at one end extending past the base towards the cap, and extending into the monitor so as to engage a switch, the arrangement being such that the lever is operatively engaged by the cap as it is attached, and thereby changes the state of the switch.

5. An adherence monitor according to claim 4, wherein the monitor includes a processor, and the processor is in communication with the switch so as to receive an indication of the state of the switch.

6. An adherence monitor according to claim 5, wherein the monitor is adapted to send external communications indicative of the usage of the dispenser, said communications selectively including an indication of whether the cap detection sensor has sensed that the cap is attached or has been removed.

7. An adherence monitor according to claim 6, wherein the indication is associated with record of a usage event at the dispenser.

8. An adherence monitor according to any one of claims 4 to 7, wherein the adherence monitor further includes a dose detection mechanism, and the dose detection mechanism is disabled until the cap detection sensor detects that the cap is removed.

9. An adherence monitor according to any one of claims 4 to 8, wherein the opening includes internal resilient projections, arranged so that operatively the base can be received and retained in the opening, and the base can be rotated by rotating the monitor.

10. An adherence monitor according to any one of claims 4 to 9, wherein the monitor has a body formed from a first polymer material, and the resilient projections are formed within the opening as an overmould of a second polymer material, the second material being more compliant than the first polymer material.

1 1 . An adherence monitor according to any one of claims 4 to 10, wherein the base is retained in the opening by compressing the projections, so as to form an interference fit.

12. An adherence monitor including a dose detection sensor and a cap detection sensor, wherein the adherence monitor further includes a dose detection mechanism, and the dose detection mechanism is disabled until the cap detection sensor detects that the cap is removed.

13. A method of retaining a dry medicament dispenser in an adherence device, the method including:

providing a recess in the adherence device, the recess including resilient projections, inserting the rotatable base of the adherence device within the recess, the insertion compressing the resilient projections, so as to retain the base of the dispenser within the adherence device, and so that rotation of the adherence device also rotates the rotatable base.

14. A cap detection sensor for a dry medicament dispenser, the dispenser including a rotatable base, a mouthpiece, and a removable cap for the mouthpiece, the sensor including a lever extending generally parallel to the axis of rotation of the base, the lever at one end extending past the base towards the cap, and extending into the dispenser so as to engage a switch, the arrangement being such that the lever is operatively engaged by the cap as it is attached, and thereby changes the state of the switch.

15. A cap detection sensor according to claim 14, wherein the dispenser includes a processor, and the processor is in communication with the switch so as to receive an indication of the state of the switch.

16. A cap detection sensor according to claim 15, wherein the dispenser is adapted to send external communications indicative of the usage of the dispenser, said communications selectively including an indication of whether the cap detection sensor has sensed that the cap is attached or has been removed.

17. A cap detection sensor according to claim 16, wherein the indication is associated with record of a usage event at the dispenser.

18. A dry medicament dispenser including a cap detection sensor according to any one of claims 14 to 17.

19. A dry medicament dispenser according to claim 18, wherein the dispenser further includes a dose detection mechanism, and the dose detection mechanism is disabled until the cap detection sensor detects that the cap is removed.