Compliance monitor for a medicament inhaler

Abstract

Some embodiments are directed to a compliance monitor for monitoring patient usage of a medicament inhaler, the medicament inhaler including a store of medicament, a first housing for housing the store of medicament, a medicament dispenser for delivering a dose of medicament, a mouthpiece for directing the dose of medicament into the mouth of the patient, and a removable and replaceable cap for the mouthpiece. The compliance monitor includes a cap detector, such as a switch, for determining when the cap is covering the mouthpiece and/or for determining that the cap is being removed or replaced, with respect to the mouthpiece. The compliance monitor may also include a dose detector, such as a switch, for determining that a dose of medicament has been dispensed. Furthermore the cap is attached to the first housing by a tether or hinge.

Claims

1. A compliance monitor for monitoring patient usage of a medicament inhaler, the medicament inhaler including: (a) a store of medicament, (b) a first housing for housing the store of medicament, (c) a medicament dispenser for delivering a dose of medicament, (d) a mouthpiece for directing the dose of medicament into the mouth of the patient, (e) a removable and replaceable cap for the mouthpiece, and the compliance monitor comprising: (f) a cap detector configured to perform at least one of: determining when the cap is covering the mouthpiece, and determining that the cap is being removed or replaced, with respect to the mouthpiece, (g) a dose detector configured to determine that a dose of medicament has been dispensed, wherein the compliance monitor is housed within a second housing, wherein the second housing is releasably attachable to the medicament inhaler, and wherein the compliance monitor is configured to determine when the user dispenses a dose of medicament as the cap is being removed or replaced based on data from the dose detector and the cap detector.

2. The compliance monitor as claimed in claim 1, wherein the compliance monitor is configured to determine when the user dispenses, or attempts to dispense, the dose of medicament when the cap is covering the mouthpiece of the medicament inhaler based on data from the dose detector and the cap detector.

3. The compliance monitor as claimed in claim 1, wherein the compliance monitor further includes an electronics control module (ECM), the ECM being in electronic communication with the dose detector and the cap detector.

4. The compliance monitor as claimed in claim 3, wherein the ECM is configured to monitor and/or manipulate and/or store and/or transmit data relating to patient usage of the medicament inhaler.

5. The compliance monitor as claimed in claim 1, wherein the cap is attached to the first housing of the medicament inhaler by a tether.

6. The compliance monitor as claimed in claim 5, wherein the cap detector includes a switch, and this switch is configured to be actuated, or de-actuated, by the tether during the action of removing or replacing the cap.

7. The compliance monitor as claimed in claim 6, wherein the switch is located on the first housing.

8. The compliance monitor as claimed in claim 6, wherein the switch is located on the second housing.

9. The compliance monitor as claimed in claim 5, wherein the cap detector includes a switch, and this switch is configured to be actuated by the tether when the cap is covering the mouthpiece.

10. The compliance monitor as claimed in claim 1, wherein the cap is attached to the second housing by a tether.

11. The compliance monitor as claimed in claim 1, wherein the second housing is adapted to partially enclose the medicament inhaler.

12. The compliance monitor as claimed in claim 1, wherein the second housing is adapted to full enclose and/or encircle the medicament inhaler.

13. The compliance monitor as claimed in claim 1, wherein the compliance monitor further includes a spacer detector configured to determine that a spacer is being removed from or replaced on the medicament inhaler and the compliance monitor is configured to determine when the user dispenses the dose of medicament as the spacer is being removed or replaced.

14. The compliance monitor as claimed in claim 1, the second housing comprising: a) a first portion for receiving and/or retaining a base portion of the medicament inhaler, b) a second portion for releasably securing the medicament inhaler to the first portion, thereby releasably attaching the compliance monitor to the medicament inhaler, the arrangement and construction being such that a fitting of the second portion of the second housing to the first portion of the second housing includes: a screw fit.

15. A compliance monitor for monitoring patient usage of a medicament inhaler, the medicament inhaler including: (a) a store of medicament, (b) a first housing for housing the store of medicament, (c) a medicament dispenser for delivering a dose of medicament, (d) a mouthpiece for directing the dose of medicament into the mouth of the patient, (e) a removable and replaceable cap for the mouthpiece, and the compliance monitor comprising: (f) a cap detector configured to perform at least one of: determining when the cap is covering the mouthpiece, and determining that the cap is being removed or replaced, with respect to the mouthpiece, (g) a dose detector configured to determine that a dose of medicament has been dispensed, wherein the compliance monitor is housed within a second housing, wherein the second housing is releasably attachable to the medicament inhaler, and wherein data gathered by the dose detector and the cap detector is configured to be sent to an ECM, which is configured to determine if the user has dispensed the dose of medicament as the cap is being removed or replaced based on the data.

16. A compliance monitor for monitoring patient usage of a medicament inhaler, the medicament inhaler including: (a) a store of medicament, (b) a first housing for housing the store of medicament, (c) a medicament dispenser for delivering a dose of medicament, (d) a mouthpiece for directing the dose of medicament into the mouth of the patient, (e) a removable and replaceable cap for the mouthpiece, and the compliance monitor comprising: (f) a cap detector configured to perform at least one of: determining when the cap is covering the mouthpiece, and determining that the cap is being removed or replaced, with respect to the mouthpiece, (g) a dose detector configured to determine that a dose of medicament has been dispensed, wherein the compliance monitor is housed within a second housing, wherein the second housing is releasably attachable to the medicament inhaler, and wherein data gathered by the dose detector and the cap detector is configured to be sent to an ECM, which is configured to determine if the user has dispensed, or attempted to dispense, the dose of medicament when the cap is covering the mouthpiece of the medicament inhaler based on the data.

17. The compliance monitor as claimed in claim 15 or claim 16, wherein the compliance monitor further includes an indicator configured to alert the user if the ECM determines that: (a) with regard to claim 15, the user has dispensed the dose of medicament as the cap is being removed or replaced or (b) with regard to claim 16, if the user has dispensed, or attempted to dispense, the dose of medicament when the cap is covering the mouthpiece of the medicament inhaler.

18. The compliance monitor as claimed in claim 17, wherein the indicator is in the form of a visual and/or audio and/or audio-visual indicator.

Description

DRAWINGS

(1) FIG. 1: is a cut-away side view showing one possible embodiment of the invention, with the cap removed from the mouthpiece of a pMDI medicament inhaler,

(2) FIG. 2: is a view of the embodiment illustrated in FIG. 1, with the cap attached to the mouthpiece of the pMDI medicament inhaler,

(3) FIG. 3: is a rear view of the embodiments illustrated in FIGS. 1 & 2,

(4) FIG. 4: is a view of another possible embodiment of the present invention, when applied to a TURBUHALER DPI,

(5) FIG. 5: is a perspective view of another possible embodiment of the present invention, when applied to a TURBUHALER DPI,

(6) FIG. 6: is a perspective view of the compliance monitor illustrated in FIG. 5,

(7) FIG. 7: is an exploded view of the compliance monitor illustrated in FIG. 6,

(8) FIG. 8: is an inverted perspective view of the exploded view illustrated in FIG. 7, and

(9) FIG. 9: is an inverted perspective front view of the compliance monitor illustrated in FIGS. 1 to 3.

DESCRIPTION OF PREFERRED EMBODIMENTS

(10) Having regard to FIGS. 1 and 2 there is shown a pMDI medicament inhaler, generally indicated by arrow 1.

(11) The medicament inhaler 1 includes a store of medicament in the form of a pressurised medicament canister 2, and a first housing (for housing the canister 2) in the form of an actuator 3.

(12) The inhaler 1 is also provided with a medicament dispensing means for delivering a dose of medicament. The medicament dispensing means is in the form of a spray stem 4 extending from the canister 2, which is adapted to engage with a spray-directing element 5 housed within the actuator 3. When the canister 2 is pushed down into the actuator 3, the spray stem 4 and spray-directing element 5 combine to deliver a metered dose of medicament out through the mouthpiece 6 of the actuator 3, and into the mouth of the user (who sucks on the mouthpiece 6 at the same time that the medicament is dispensed).

(13) The inhaler 1 is also provided with a removable and replaceable cap 7, which is adapted to close off the mouthpiece 6 when the inhaler 1 is not in use.

(14) The cap 7 ensures that the mouthpiece 6 remains clean, and free from dust and grime, and also ensures that no foreign objects (such as coins) can enter the mouthpiece 6 (for example when the inhaler is not in use or being carried in a pocket or purse), which may otherwise present a choking hazard.

(15) The cap 7 is attached to the rear of the actuator 3 by a tether 15. Having the cap 7 tethered to the actuator 3 in such a fashion ensures that the cap 7 is not inadvertently dropped or lost once it has been removed. Furthermore, having a tethered cap 7 ensures that the cap 7 does not become a choking hazard (that is, the cap 7 could not inadvertently be swallowed by a user because it is attached to the actuator 3, via the tether 15).

(16) The inhaler 1 also includes a compliance monitor, generally indicated by arrow 8.

(17) The compliance monitor 8 is housed within a second housing 9, which is releasably attachable to the inhaler 1 (or more specifically to the actuator 3).

(18) As may be best seen in FIG. 3, the second housing 9 only partially encloses the inhaler 1. That is, the second housing 9 encloses the sides and front of the inhaler 1, however the rear of the second housing 9 is left open. This rear opening allows for the inhaler 1 to be placed into, and removed from, the second housing 9. When the inhaler 1 is placed into the second housing 9, the bottom 10 of the actuator housing 3 rests on the ledges 11 formed along the bottom sides of the second housing 9.

(19) The compliance monitor 8 includes an ECM (not shown, but see FIG. 3) which is included within one side 13 of the second housing 9.

(20) The ECM is adapted to monitor and/or manipulate and/or store and/or transmit compliance data relating to patient usage of the inhaler 1.

(21) Because the second housing 9 is releasably attachable to the inhaler 1, it may be appreciated that the compliance monitor 8 may be portable and/or reusable across a range of different medicament inhalers.

(22) The compliance monitor 8 includes a dose detection means in the form of a first electromechanical switch 14, which is in electronic communication with the ECM. The first switch 14 is located on a lower internal surface of the second housing 9, and the first switch 14 therefore abuts the bottom 10 of the actuator 2.

(23) When a dose of medicament is dispensed, the canister 2 is pushed down into the actuator 3, as described previously. This pressure forces the bottom 10 of the actuator 3 against the first switch 14, which closes (or actuates) the first switch 14, and thus the dispensing of the dose is detected, and an appropriate signal is sent to the ECM, where the dispensing of the dose is recorded, and the date and time of the dispensing of the dose is also recorded. Such a dose detecting apparatus has been previously described in our patent application WO2013/043063, which is incorporated herein, in its entirety, by reference.

(24) The compliance monitor 8 also includes a cap detection means.

(25) The cap detection means includes a second switch 16 located on the underside of the lower surface of the second housing 9 (that is, the underside of the compliance monitor 8). Further, the tether 15 includes a protrusion 17 which is adapted to butt up against, and therefore actuate (or de-actuate), the second switch 16 during the action of removing and replacing the cap 7 (with respect to the mouthpiece 6 of the inhaler 1).

(26) Hence, the action of removing and/or replacing the cap 7 results in an actuation (or de-actuation) of the second switch 16 (by the protrusion 17 of the tether 15), and an appropriate electrical signal is sent to the ECM.

(27) If, at the same time as removing or replacing the cap 7, the user inadvertently dispenses a dose of medicament, the cap detection means and the dose detection means (second switch 16 and first switch 14 respectively) will combine to detect this, and appropriate electrical signals will be sent to the ECM. The ECM will, upon receiving both signals (more or less simultaneously) be able to determine that a dose of medicament has not in fact been dispensed to the user, and that instead a user error has occurred, and this determination may be stored and/or transmitted, as described previously.

(28) Furthermore, (and as illustrated in FIG. 2) the protrusion 17 of the tether 15 is adapted to butt up against, and therefore continually actuate, the second switch 16 when the cap 7 is covering the mouthpiece 6 of the inhaler 1.

(29) Hence, an appropriate electrical signal may be continually sent to the ECM indicating that the cap 7 is attached to the mouthpiece 6. If the user dispenses, or attempts to dispense, a dose of medicament whilst the cap 7 is attached to the mouthpiece 6, the cap detection means and the dose detection means (second switch 16 and first switch 14 respectively) will combine to detect this, and appropriate electrical signals will be sent to the ECM. The ECM, will thus be able to determine that the dose was dispensed (or attempted to be dispensed) with the cap 7 attached, and this determination may be stored and/or transmitted, as described previously.

(30) Alternatively, and/or additionally, the user may be alerted to either of the above two errors by an indication means, substantially as described previously (indication means not shown in the drawings).

(31) In such a fashion, it may be appreciated that compliance data relating to two common user errors of medicament inhalers may be collected, stored and/or used to provide feedback to the user regarding their techniques, and/or prompt a health professional to provide or schedule further training for the user in relation to their use of the medicament inhaler 1.

(32) Furthermore, either the user or a health care professional may be alerted to the fact that the user has not taken their medicament, even though a dose has been dispensed. This is an important consideration for a user who thought that they did in fact take their medicament (in the situation where the cap 7 is left on during the administering of a dose of medicament), and so that person can be alerted to take another dose (with the cap 7 removed). Hence, as well as ensuring proper medicament compliance generally, the compliance monitor 8 may also potentially prevent an exacerbation event.

(33) It is fairly common for users to either inadvertently leave the cap 7 on when administering a dose of medicament and/or inadvertently dispense a dose of medicament when removing or replacing the cap 7, and these type of errors have potentially adverse consequences. For example, the patient may become ill or incapacitated (or worse) as a result of not having received their medicament at the required time.

(34) Furthermore, a health care professional upon reviewing skewed compliance data (that is, data supplied by an inhaler that does not utilise the compliance monitor 8) may change the dosage regime that the user is currently on, without releasing that not as many doses of medicament have been taken as was thought. This scenario is clearly undesirable, and the compliance monitor 8 therefore serves as a very useful and important tool to address these type of issues.

(35) Having regard to FIGS. 4 to 8, there is shown further possible embodiments of the present invention. FIGS. 4 to 8 illustrate medicament inhalers in the form of TURBUHALER DPI inhalers, generally indicated by arrow 21.

(36) Having regard to FIG. 4, the inhaler 21 includes a store of medicament in the form of a dry powder (not shown) housed within a first (circular) housing 22. The inhaler 21 includes a medicament dispensing means in the form of a rotatable base 23. A metered dose of medicament is dispensed into a dispensing chamber (not shown) by rotating the base 23 back and forth once. The inhaler 21 also includes a mouthpiece 24 and the medicament is inhaled by the user via the mouthpiece 24. The internal workings of the inhaler 21 assist is forcing the medicament out of the dispensing chamber, and into the mouth of the user.

(37) The inhaler 21 is also provided with a removable and replaceable (circular) cap 25, which is adapted to close off the mouthpiece 24, and also serves to close off (or enclose) the first housing 22 when the inhaler 21 is not in use.

(38) The inside surface of the lower portion of the cap 25 contains a thread 28 (shown in dotted outline).

(39) The inhaler 21 also includes a compliance monitor, generally indicated by arrow 26.

(40) The compliance monitor 26 includes a dose detection means housed within a releasably attachable second housing 27. The second housing 27 is releasably attachable to the bottom of the first housing 22, and is fixed with respect to the rotatable base 23. The action of rotating the rotatable base 23 back and forth once (to release a dose of medicament) is detected by the dose detection means, and the dispensing of a dose is therefore recorded and an electrical signal is sent to the ECM (ECM not shown, but it is also housed within the second housing 27)

(41) The compliance monitor 26 also includes a cap detection means.

(42) The cap detection means includes a circular sleeve 29, which is adapted to sit directly above the second housing 27, and is connected and/or retained thereto by a screw fit (not shown in FIG. 4). In FIG. 4 only, the inside surface of the upper portion of the circular sleeve 29 contains a thread 30 (shown in dotted outline), which is complimentary to the thread 28, whereby the cap 25 may be screwed into the circular sleeve 29, to thereby securely retain the cap 25 with respect to the circular sleeve 29 (and thereby retain the cap 25 with respect to the inhaler 21 and/or second housing 27).

(43) In FIG. 4, the action of screwing the cap 25 into the circular sleeve 29 has the effect of closing two electrical contacts (not shown), and when these contacts are closed, an electrical signal is sent to the ECM to indicate that the cap is attached to the inhaler 21. Likewise, when the cap 25 is unscrewed from the circular sleeve 29, the electrical contacts are opened, and an appropriate signal is again sent to the ECM to indicate that the cap has been removed from the inhaler 21.

(44) If the ECM receives a signal that a dose of medicament has been dispensed at substantially the same time that that cap 25 has been removed, it can be determined that the dose has been inadvertently dispensed during the removal of the cap 25. Likewise, if the ECM receives a signal that a dose of medicament has been dispensed with the cap 25 still secured to the inhaler 21, the ECM can determine this. Furthermore if doses of medicament are continually dispensed with the cap 25 remaining on, it can be determined that the user has not been taking their medicament.

(45) Hence, a person reviewing such compliance data can be alerted to these incorrect techniques and the user can thus be alerted, with possibly a view to further training in the use of the inhaler 21.

(46) Having regard to FIGS. 5 to 8, the cap detection means includes the circular sleeve 29, which is adapted to sit directly above the second housing 27, and is connected and/or retained thereto by a screw fit.

(47) The outside top portion of the second housing 27 contains a thread 31 which is complimentary to the thread 32 of the inside lower surface of the circular sleeve 29. Once the base of the inhaler 21 is placed in the grip portion 33 of the second housing 27, the circular sleeve 29 can be screwed onto the second housing 27 thereby securing the compliance monitor 26 to the inhaler 21.

(48) In FIGS. 5 to 8, the cap 25 is screwed onto the base of the inhaler (rather than being screwed into the circular sleeve 29as per FIG. 4).

(49) When the inhaler 21 is fitted into the compliance monitor 26 without the cap 25, spring switches 34 are left open. When the cap 25 is fitted onto the inhaler 21 and screwed onto it tightly, the base of the inhaler 21 is pulled up towards the rim 35 of the circular sleeve 29 and the spring switches 34 are therefore closed.

(50) The compliance monitor 26 further includes a PCB contact switch 36 on the top outer portion of the second housing 27 which engages with contact point 37 on the inside of the circular sleeve 29 to detect that the parts are fitted together.

(51) The compliance monitor 26 may also include a latch 38 which secures the circular sleeve 29 and second housing 27 together, until the latch 38 is released before the parts are unscrewed.

(52) The compliance monitor 26 may further include a LED light 39, for example to indicate that the parts 27 and 29 are properly attached and/or to indicate that the compliance monitor 26 has been properly attached to the inhaler 21.

(53) Having regard to FIG. 9, there is shown an inverted perspective front view of the compliance monitor 8 illustrated in FIGS. 1 to 3.

(54) In FIG. 9, the switch 16, which is part of the cap detection means, is shown in greater detail on the underside of the second housing 9.

(55) As previously mentioned, the tether 15 includes a protrusion 17 which is adapted to butt up against, and therefore actuate (or de-actuate), the switch 16 during the action of removing and replacing the cap 7 (with respect to the mouthpiece 6 of the inhaler 1). Hence, the action of removing and/or replacing the cap 7 results in an actuation (or de-actuation) of the switch 16 (by the protrusion 17 of the tether 15), and an appropriate electrical signal is sent to the ECM.

(56) Furthermore, the protrusion 17 of the tether 15 is adapted to butt up against, and therefore continually actuate, the switch 16 when the cap 7 is continuously covering the mouthpiece 6 of the inhaler 1.

VARIATIONS

(57) 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.