DEVICE WITH FLOW RATE INDICATOR

Abstract

A drug receptacle for use with a respiratory inhaler device. The drug receptacle has a fluid flow rate indicator on an outer surface thereof. The fluid flow rate indicator comprises a corrugated portion having at least one and preferably a plurality of corrugations extending radially from the outer surface of the drug receptacle. The flow rate indicator is operable to generate a sound signal. The present invention also relates to a corrugated flow rate indicator having a connection portion for connection to the outer surface of a drug receptacle.

Claims

1. A drug receptacle for use with a respiratory inhaler device, the drug receptacle having a fluid flow rate indicator on an outer surface thereof.

2. A drug receptacle according to claim 1 wherein the fluid flow rate indicator comprises a corrugated portion having at least one and preferably a plurality of corrugations extending radially from the outer surface of the drug receptacle, the flow rate indicator being operable to generate a sound signal.

3. A drug receptacle according to claim 1 wherein the corrugated portion is integrally formed as part of the outer surface of the drug receptacle.

4. A drug receptacle according to claim 1 wherein the flow rate indicator/corrugated portion is separately formed and affixed to the outer surface of the drug receptacle.

5. A drug receptacle according to claim 1 wherein the corrugated portion completely encircles the outer surface of the drug receptacle.

6. A drug receptacle according to claim 1 wherein the corrugated portion extends the entire axial length of the drug receptacle.

7. A drug receptacle according to claim 1 wherein the corrugated portion has an axial length of between 2 and 70 mm.

8. A flow rate indicator having a connection portion for connection to an outer surface of a drug receptacle for use with a respiratory inhaler device.

9. A flow rate indicator according to claim 8 wherein the connection portion forms or is formable into a complete or partial sleeve defining a bore for housing at least part of the drug receptacle.

10. A flow rate indicator according to claim 8 wherein the connection portion is a sleeve or clip defining a bore for forming an interference fit with the tubular body of the drug receptacle.

11. A flow rate indictor according to claim 8 wherein the connection portion is flexible for flexing into a profile conforming to at least a portion of the outer surface of the drug receptacle.

12. A flow rate indicator according to claim 11 wherein the connection portion comprises an adhesive layer for adhesively securing the connection portion to the outer surface of the drug receptacle.

13. A flow rate indicator according to claim 8 wherein the flow rate indicator comprises a corrugated portion having at least one and preferably a plurality of corrugations provided on an outer surface of the connection portion.

14. A respiratory inhaler device for delivery of a drug to a patient, the device comprising: an aperture for inlet of air into the device; a mouthpiece for communication with the mouth of a patient; a device body defining an air flow path extending from the aperture to the mouthpiece along which air is drawn to the mouthpiece by inhalation by the patient, the device body housing a drug receptacle according to claim 1.

15. A system comprising a device according to claim 14 and a sound receiver for detecting the sound signal.

16. A system according to claim 15 wherein the sound receiver comprises a computer software application for running on a mobile device.

17. A method of monitoring actuation of a respiratory inhaler device for delivery of a drug to a patient, the method comprising: providing a system according to claim 15, detecting the sound signal generated when the air flow rate along the air flow path is at or above the predetermined minimum level suitable for delivery of the drug to the patient, detecting a change in frequency of the sound signal upon actuation of the device by the patient.

18. A method according to claim 17 further comprising recording the change in the sound signal upon actuation of the device.

19. A method according to claim 17 further comprising recording the duration of the sound signal after actuation of the device.

20. A respiratory inhaler device for delivery of a drug to a patient, the device comprising: an aperture for inlet of air into the device; a mouthpiece for communication with the mouth of a patient; a device body defining an air flow path extending from the aperture to the mouthpiece along which air is drawn to the mouthpiece by inhalation by the patient, the device body housing a drug receptacle fitted with a flow rate indictor device according to claim 8.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0082] Embodiments of the invention will now be described by way of example with reference to the accompanying drawings in which:

[0083] FIG. 1 shows a longitudinal cross-sectional view through a first embodiment of a respiratory inhaler device according to an aspect of the present invention;

[0084] FIG. 2 shows a perspective view of a first embodiment of a flow rate indicator according to an aspect of the present invention;

[0085] FIG. 3a shows a perspective view of a second embodiment of a flow rate indicator according to an aspect of the present invention;

[0086] FIG. 3b shows the flow rate indicator of FIG. 3a, as applied to a drug canister

[0087] FIG. 4 shows a perspective view of a third embodiment of a flow rate indicator according to an aspect of the present invention;

[0088] FIG. 5a shows a perspective view of a fourth embodiment of a flow rate indicator according to an aspect of the present invention;

[0089] FIG. 5b shows the flow rate indicator of FIG. 5a, as applied to a drug canister; and

[0090] FIG. 6 shows a perspective view of a fifth embodiment of a flow rate indicator according to an aspect of the present invention.

DETAILED DESCRIPTION AND FURTHER OPTIONAL FEATURES OF THE INVENTION

[0091] FIG. 1 shows a longitudinal cross-sectional view through a first embodiment of the present invention which comprises a pressurised metered dose inhaler (pMDI) 1 adapted to deliver respiratory drugs to a patient. The body of the pMDI 1 comprises an upright portion 2 having an aperture 3 for inlet of air into the pMDI and a transverse mouthpiece 4 for communication with the mouth of a patient. The upright portion 2 defines an air flow path extending from the aperture 3 to the transverse mouthpiece 4. The upright portion 2 is substantially cylindrical (with a substantially circular transverse cross-section) and the transverse mouthpiece 4 has a substantially oval or barrel-shaped transverse cross-section. This provides an oval or barrel-shaped mouthpiece 4 that can easily form a seal with the patient's mouth.

[0092] The upright portion has an internal diameter of around 24-28 mm.

[0093] The pMDI further comprises a seat 5 for location of a drug canister 6 containing a respiratory drug at the junction between the upright portion 2 and the transverse mouthpiece 4. The canister 6 is inserted into the upright portion 2 of the body through the aperture 3 and is housed in the upright portion 2.

[0094] The drug canister 6 comprises a tubular body having an integrally formed corrugated portion 7 which comprises a series of parallel ridges 8 and troughs 9. The ridges 8 and troughs 9 are integrally formed (moulded) into the outer surface of the tubular body of the drug canister 6 and are oriented substantially perpendicularly to the axis of the tubular body of the drug canister 6 and the air flow path 10.

[0095] The ridges 8 and troughs 9 partially encircle the canister 6 and extend the entire axial length of the tubular body of the drug canister from the closed axial end 12 to the open axial end 13 fitted with a metering valve 14 housed in the seat 5.

[0096] The axial length of the corrugated portion 7 is approximately 30 mm in length and comprises ridges 8 and troughs 9 having a pitch of 3 mm.

[0097] The corrugated portion 7 comprises a lead-in ridge (not pictured) at its axial end proximal the closed axial end 12 such that as air first enters the corrugated portion 7 it is directed away from the axis of the tubular body of the drug canister 6 by the inclined surface of the lead-in ridge.

[0098] To use the pMDI 1, the patient will insert the mouthpiece 4 into their mouth and inhale. The air flowing into the upright portion 2 of the body through the aperture 3 will flow around the canister 6, over the corrugated portion 7 and into the transverse mouthpiece.

[0099] At the predetermined minimum flow rate which is the minimum air flow rate for optimal drug inhalation, the air drawn along the air flow path will become turbulent as a result of the air tumbling over the ridges 8 and troughs 9 of the corrugated portion 7. When the oscillations match the resonant frequency of the corrugated portion of the body, a sound signal having a narrow frequency width will be generated and the patient will know that the optimal inhalation rate has been achieved.

[0100] The generation of the sound signal may be detected by ear by the patient or the patient may be provided with software (e.g. in the form of a mobile phone app) to detect the generation of the sound signal and thus the attainment of the predetermined minimum flow rate for optimal drug delivery.

[0101] When the optimal inhalation rate has been achieved, the patient will then know to actuate the drug canister 6 to release the drug into the air flow path for inhalation. Actuation of the canister 6 is typically achieved by depressing the canister 6 into the upright portion 2 of the body. This causes an interaction between the canister 6 and the seat 5 that causes a metered dose of liquid to be ejected from the canister 6, along with a propellant gas. The liquid is aerosolized, for inhalation by the patient. A drug of particular interest is salbutamol, marketed under the example trade names Ventolin, Aerolin, Ventorlin, Asthalin, Asthavent, Proventil and ProAir, for the management of asthma and other respiratory diseases.

[0102] Upon depression of the canister 6, the frequency/pitch of the sound signal will change as a result of the change in the axial length/geometry of the corrugated portion 7. In situations where there is a desire to monitor patient compliance and/or monitor the alteration in the frequency/pitch of the sound signal, the sound signal could be monitored/recorded (e.g. by the computer software/mobile app) to detect the point of actuation of the canister. The duration of the sound signal after actuation could also be monitored/recorded to help ensure that the optimal flow rate is maintained for a sufficient period of time after actuation.

[0103] FIGS. 2 to 6 show flow rate indicators for fitting to an off-the-shelf drug canister 6.

[0104] FIG. 2 shows a flow rate indicator 20 having a flexible corrugated portion 7 provided on a flexible adhesive connection portion (not shown). The connection portion/corrugated portion is flexible and can be deformed from a planar profile to a sleeve profile matching the profile of the outer surface of the drug canister and defining a bore for surrounding the outer surface of a drug canister. The adhesive layer can be used to affix the flow rate indicator to a drug canister. Flow rate indicator 20 may therefore be considered as being part of a label (e.g. adhesive label) for application to a drug canister.

[0105] FIG. 3a shows a flow rate indicator 30 where the connection portion comprises a full, rigid sleeve defining a bore 15 into which a drug canister can be housed in an interference fit. Flow rate indicator 30 may be considered as being part of a sleeve (e.g. rigid sleeve) for application to a drug canister 6.

[0106] FIG. 3b shows the flow rate indicator 30 of FIG. 3a, as applied to a drug canister 6.

[0107] FIG. 4 shows a flow rate indicator 40 where the connection portion comprises a continuous clip portion 16 defining a bore 15 into which a drug canister can be fitted. Flow rate indicator 40 may therefore be considered as being part of a clip (e.g. semi-rigid or rigid clip) for application to a drug canister.

[0108] FIG. 5a shows a flow rate indicator 50, similar to the flow rate indicator 40 of FIG. 4, except for the fact that the clip portion 16 comprises two arms, which jointly only extend part of the way around the body of the drug canister 6, e.g. 50-60% of the way around. The arms of the clip portion 16 are, as with the clip portion 16 of flow rate indicator 40, rigid or semi-rigid.

[0109] FIG. 5b shows the flow rate indicator of FIG. 5a, as applied to a drug canister 6.

[0110] FIG. 6 shows a flow rate indicator 60, similar to the flow rate indicators 50 of FIG. 5, except for the fact that the two arms of the clip portion 16 extend almost all of the way around the drug canister 6, e.g. between 90-100% of the way around the drug canister.

[0111] pMDI drug canisters typically have a tubular body with a diameter of between 20 and 25 mm, and an axial length of between 30 and 100 mm.

[0112] The flow rate indicator may thus have a height, in the axial direction (e.g. the axial direction when mounted on a drug canister), of 10-100 mm. The flow rate indicator may have a width (e.g. in the circumferential direction when mounted on a drug canister) of up to 78 mm. Accordingly, the flow rate indicator may cover only a part of the tubular body portion of a drug canister (e.g. where the canister has a tubular length of 100 mm and a tubular diameter of 25 mm, and the flow rate indicator has a length of less than 100 mm, and/or a width of less than 78 mm).

[0113] Alternatively, the flow rate indicator can cover the entire tubular body portion of a drug canister (e.g. where the canister has a tubular length of 100 mm and a tubular diameter of 25 mm, and the flow rate indicator has a length of 100 mm, and/or a width of 78 mm).

[0114] While the invention has been described in conjunction with the exemplary embodiments described above, many equivalent modifications and variations will be apparent to those skilled in the art when given this disclosure. Accordingly, the exemplary embodiments of the invention set forth above are considered to be illustrative and not limiting. Various changes to the described embodiments may be made without departing from the spirit and scope of the invention.

[0115] All references referred to above are hereby incorporated by reference.