WO2002091293A1

WO2002091293A1 - Counter

Info

Publication number: WO2002091293A1
Application number: PCT/GB2002/002112
Authority: WO
Inventors: Philip Braithwaite
Original assignee: Ml Laboratories Plc
Priority date: 2001-05-01
Filing date: 2002-05-10
Publication date: 2002-11-14
Also published as: GB0111329D0

Abstract

There is described a counter mechanism (1) which comprises a resiliently deformable actuator member (2) which is operably linked to a counter member (3), the actuator being moveable from a first position, in which it has a raised profile, to a second position in which it has a lowered profile and wherein the link between the actuator and the counter converts the movement of the actuator into rotational movement of the counter. There is also described a medicament delivery device, e.g. an inhaler, such as MDI or DPI comprising such a counter mechanism.

Description

Counter

This invention relates to a novel form of counter mechanism and to devices comprising the novel counter.

It is well established that a medicament delivery device, e.g. such as an inhaler, requires a dose counter so as to assist, inter alia, patient compliance,

European Patent Application No. 0 448 204 describes an inhaler device with a counter means. An electronic counter is connecting to the main body of the inhaler.

International Patent Application No. WO 00/59806 describes an inhaler which comprises a pressurised container housed in an inner housing, said housing being provided with an external helical groove. A ring fits around the pressurised container and is provided with a pair of pins which sit in the groove. When the container is actuated, the pins slide in the groove and thus each actuation is counted.

However, one disadvantage of known counter mechanisms is that they may require a high force for the counter to be activated. Furthermore, prior art counters tend to be complex in construction and therefore may be difficult to incorporate into a delivery system, may be more difficult to manufacture and/or may be costly. Thus, there is a need to develop a counter which is simple in construction and overcomes or mitigates some of the disadvantages of prior art counter systems.

One particular disadvantage of the counter mechanisms of the prior art is that they are unsuitable for use with breath actuated systems. Thus, there is a need for a counter mechanism which requires minimum or low force to actuate the counter.

However, we have now found a counter mechanism which requires minimal movement and minimum force. The mechanism is suitable for use in a variety of medicament delivery systems but may be especially suited for the delivery of medicament in a breath actuated inhaler.

Thus, according to the invention we provide a counter mechanism which comprises a resiliently deformable actuator member which is operably linked to a counter member, the actuator being moveable from a first position, in which it has a raised profile, to a second position in which it has a lowered profile and wherein the link between the actuator and the counter converts the movement of the actuator into movement of the counter.

The movement of the counter may in a different plane to that of the actuator. The movement of the counter may be linear but is, preferably substantially rotational.

Preferentially, at least one outer region of the actuator is provided with an engaging member adapted to engage with a counter member. More particularly, when the actuator is deformed the engaging means urges the counter to move from a first position to a second position. More especially, as the actuator is deformed, the counter moves relative to the engaging means.

In a particular embodiment of the invention the engaging means comprises a peripheral pin. The counter member may thus be provided with a guide track to engage the pin. The track may be shaped so as to move the counter relative to the pin as the actuator is deformed. The guide track may preferably follow a "staggered" or "zig-zag" path. Thus, the track will comprise a plurality of shoulders adjacent the periphery of the counter member and a plurality of shoulders distal to the periphery, i.e. towards the centre, of the counter member. When the actuator is in the rest position the actuator pin rests against the distal shoulder. When the actuator is deformed the c'ounter is urged to move, e.g. rotate, so as to enable the actuator pin to move to the peripheral shoulder. In an especially preferred embodiment the actuator member is provided with a plurality of pins.

In a further embodiment the actuator may comprise a resiliently deformable member which comprises a plurality of limbs, e.g. from 2 to 5 limbs. Each limb may preferentially be provided with a pin, e.g. at the terminal end of the limb.

Thus according to the invention we provide a delivery device, e.g. a medicament delivery device comprising a medicament counter mechanism as hereinbefore described.

Thus, for example, we provide a delivery device comprising a medicament reservoir, a metering member and a delivery channel characterised in that the delivery device comprises a counter mechanism as hereinbefore described.

The delivery device of the invention may comprise any conventionally known medicament device. However, the mechanism of the present invention is especially suited for use as an inhaler, including, for example, an MDI, a DPI, an insufflator and a nebuliser.

By the term inhaler used herein, it is intended to mean any of the aforementioned devices. In a preferred embodiment, the inhaler of the invention may comprise an MDI and/or a DPI.

Furthermore, although oral administration is referred to, it would be well understood by the skilled man that the delivery device may be suitable for use in relation to other routes of administration, e.g. nasal administration.

Thus according to the invention we provide a delivery device as hereinbefore described characterised in that the device is an inhaler. The medicament reservoir may be a bulk reservoir, in which a separate metering mechanism is provided. Such an arrangement is described in International Patent application No. WO 92/00771, which is incorporated herein by reference. Alternatively, if the medicament reservoir comprises unit dosage means, then the medicament reservoir and metering mechanism may comprise a single unit. Such an arrangement is described in European Patent No. 664 239, which is also incorporated herein by reference. Alternatively, the reservoir may comprise a pressurised aerosol.

In the invention the inhaler may optionally include a conventionally known breath actuated mechanism. Thus, the counter mechanism of the invention may be actuated separately, simultaneously or sequentially with such breath actuated mechanism.

According to a yet further aspect of the invention we provide a method of treating a patient with a respiratory disorder which comprises administering a therapeutically effective amount of a medicament using an inhaler as hereinbefore described.

According to a further feature of the invention we provide a method of drug delivery to a patient which comprises administering a medicament to a patient suffering a respiratory disorder which comprises administering a therapeutically effective amount of a medicament using an inhaler as hereinbefore described.

The inhaler of the invention is advantageous in that, inter alia, it enables the delivery of dispersions of finely divided forms of medicament and avoids some if the disadvantageous of agglomeration experienced with some known DPIs.

A variety of medicaments maybe administered by using the inhaler of the invention, such medicaments may have a systemic or non-systemic activity on the patient. Such medicaments are generally (but not limiting) antibiotics, bronchodilators or other drugs for the treatment of asthma, COPD and/or respiratory infection. Such medicaments include, but are not limited to β₂-agonists, e.g. fenoterol, formoterol, pirbuterol, reproterol, rimiterol, salbutamoL salmeterol and terbutaline; non-selective beta-stimulants such, as isoprenaline; xanthine bronchodilators, e.g. theophylline, aminophylline and choline theophyllinate; anticholinergics, e.g. ipratropium bromide; mast cell stabilisers, e.g. sodium cromoglycate and ketotifen; bronchial anti-inflammatory agents, e.g. nedocromil sodium; and steroids, e.g. beclomethasone dipropionate, fluticasone, budesonide and flunisolide; and combinations thereof.

Specific combinations of medicaments which may be mentioned include combinations of steroids, such as, beclomethasone dipropionate, fluticasone, budesonide and flunisolide; and combinations of to β₂-agonists, such as, formoterol and salmeterol. It is also within the scope of this invention to include combinations of one or more of the aforementioned steroids with one or more of the aforementioned β₂-agonists.

Thus, according to a yet further feature of the invention we provide a method of treating a patient with a respiratory disorder which comprises administering a therapeutically effective amount of a medicament using an inhaler as hereinbefore described.

Further medicaments which may be mentioned include syste ically active materials, such as, proteinaceous compounds and/or macromolecules, for example, leuprolide and alpha interferon; growth factors, anticoagulants, immunomodulators, cytokines, nucleic acids, hormones, such as insulin human growth hormone and parathyroid hormone.

We also provide the use of an aerosol delivery device of the invention in the manufacture of an medicament delivery device as hereinbefore described.

It is within the scope of this invention to include combinations of any of the aforementioned medicaments. The invention will now be described by way of example only and with reference to the accompanying drawings, in which Figure 1 is a perspective cutaway representation of the invention;

Figure 2 is a perspective side view of the invention in the rest position;

Figure 3 is a perspective side view of the counter mechanism of the invention in the actuated position;

Figure 4 is a schematic representation of counter in a first position; and

Figure 5 is a schematic representation of a counter in the second position.

Referring to Figure 1, a counter mechanism (1) comprises an actuator (2) and an actuator face (3). The actuator (2) comprises limbs (4) stemming from a body (5). Each of the limbs (4) is provided with a pin (6) at the end (7) of the limb (4) distal to the body (5). Each pin (6) is provided on a first face (8) of the limb (4). The first face (8) is adjacent the actuator face (3).

The actuator face (3) comprises an annular ring (9). The ring (9) comprises a circumferential guide track (10). The track (10) has a zig-zag shape and is thus provided with peripheral shoulders (11) and inner shoulders (12).

Referring to Figures 2 and 3, when the actuator (3) is in the rest position, the pins (6) rest against the inner shoulder (12). The actuator (2) has an arcuate or raised profile.

When the actuator (2) is depressed, pins (6) are urged to the periphery of the annular actuator face (3). Thus, the actuator (2) is in a fixed position and the actuator face (3) is urged to rotate so that the pin rests against the peripheral shoulder (11). When the actuator (2) is released it returns to the raised position and is primed for the next actuation. Referring to Figures 4 and 5 the counter mechanism (1) is provided with a counter facia (12). When the actuator is engaged as described above, the counter facia moves from a first numbered position to a second numbered position.

Claims

1. A counter mechanism which comprises a resiliently deformable actuator member which is operably linked to a counter member, the actuator being moveable from a first position, in which it has a raised profile, to a second position in which it has a lowered profile and wherein the link between the actuator and the counter conveήs the movement of the actuator into movement of the counter.

2. A counter mechanism according to claim 1 characterised in that the link between the actuator and the counter converts the movement of the actuator in a first plane into movement of the counter in a second plane.

3. A counter mechanism according to claim 1 characterised in that the movement of the counter is substantially rotatable.

4. A counter mechanism according to claim 1 characterised in that when the actuator is deformed an engaging means causes the counter to move from a first position to a second position.

5. A counter mechanism according to claim 1 characterised in that when the actuator is deformed, the counter moves relative to the engaging means.

6. A counter mechanism according to claim 1 characterised in that the engaging means comprises a peripheral pin.

7. A counter mechanism according to claim 6 characterised in that the counter member is provided with a guide track to engage the pin.

8. A counter mechanism according to claim 1 characterised in that the track is shaped so as to move the counter relative to the pin as the actuator is deformed.

9. A counter mechanism according to claim 7 characterised in that the guide track follows a "staggered" or "zig-zag" path such that the track comprises a plurality of first shoulders adjacent the periphery of the counter member and a plurality of second shoulders distal to the periphery of the counter member.

10. A counter mechanism according to claim 9 characterised in that when the actuator is in the rest position the actuator pin rests against a distal or second shoulder.

11. A counter mechanism according to claim 9 characterised in that when the actuator is deformed the counter is urged to move, e.g. rotate, so as to enable the actuator pin to move to the peripheral shoulder.

12. A counter mechanism according to claim 6 characterised in that the actuator member is provided with a plurality of pins.

13. A counter mechanism according to claim 1 characterised in that the actuator comprises a resiliently deformable member which comprises a plurality of limbs.

14. A counter mechanism according to claim 13 characterised in that the actuator comprises from 2 to 5 limbs.

15. A counter mechanism according to claim 13 characterised in that each limb is provided with a pin.

16. A counter mechanism according to claim 15 characterised in that each pin is provided at the terminal end of the corresponding limb.

17. A medicament delivery device comprising a medicament counter mechanism according to claim 1.

18. A medicament delivery device according to claim 1 characterised in that the delivery device comprises a medicament reservoir, a metering member and a delivery channel.

19. A medicament delivery device according to claim 17 characterised in that the device is an inhaler.

20. A medicament delivery device according to claim 19 characterised in that the inhaler is a DPI.

21. A medicament delivery device according to claim 19 characterised in that the inhaler is an MDI.

22. A medicament delivery device according to claim 19 characterised in that the inhaler includes a breath actuated mechanism.

23. A medicament delivery device according to claim 21 characterised in that the counter mechanism is actuated separately, simultaneously or sequentially with the breath actuated mechanism.

24. A medicament delivery device according to claim 19 characterised in that the medicament is selected from the group, antibiotics, bronchodilators, anti-asthma drugs, such as β₂-agonists; fenoterol, formoterol, pirbuterol, reproterol, rimiterol, salbutamol, salmeterol and terbutaline; non-selective beta-stimulants such as isoprenaline; xanthine bronchodilators; theophylline, aminophylline and choline theophyllinate; anticholinergics such as ipratropium bromide; mast cell stabilisers, such as sodium cromoglycate and ketotifen; bronchial anti-inflammatory agents, such as nedocromil sodium; steroids, such as beclomethasone dipropionate, fluticasone, budesonide and flunisolide; and combinations thereof.

25. A medicament delivery device according to claim 24 characterised in that the combination of medicaments is selected from steroids, such as beclomethasone dipropionate, fluticasone, budesonide and flunisolide; and combinations of to β - agonists, such as, formoterol and salmeterol.

26. A medicament delivery device according to claim 1 characterised in that the medicament is systemically active.

27. A medicament delivery device according to claim 17 characterised in that the medicament is selected from a proteinaceous compound and/or macromolecules, such as hormones and mediators, such as insulin, human growth hormone, leuprolide and alpha interferon; growth factors, anticoagulants, immunomodulators, cytokines and nucleic acids.

28. A medicament delivery device according to claim 17 characterised in that the medicament is a combination selected from a medicament as defined in claim 22 and a medicament as defined in claim 23.

29. A method of administering a medicament which comprises the use of a medicament delivery device according to claim 17.

30. A method of treatment of a patient which comprises the administration of a medicament using ah inhaler according to claim 19.

31. A method according to claim 30 characterised in that the disorder is a respiratory disorder.

32. A method of treatment of a patient with a systemic disorder which comprises the administration of a medicament using an inhaler according to claim 19.

33. The use of a counter mechanism according to claim 1 in the manufacture of an medicament delivery device according to claim 17.

34. A counter mechanism or a delivery device substantially as described with reference to the accompanying examples and drawings.