GB2419292A

GB2419292A - Inhaler with hinged cap

Info

Publication number: GB2419292A
Application number: GB0423511A
Authority: GB
Inventors: Graham Walker
Original assignee: Individual
Current assignee: Individual
Priority date: 2004-10-22
Filing date: 2004-10-22
Publication date: 2006-04-26
Also published as: GB0423511D0

Abstract

An inhaler that includes an actuating plunger (3), a mouthpiece (9) and a hinged mouthpiece cap (2). The inhaler is operated such that with the cap (2) in an open position the inhaler is adapted to be held between the thumb and the forefingers of a user with the thumb pressing at least partially against a surface of the cap and the forefingers acting on the actuating plunger. Alternatively the inhaler could be held between the thumb and the forefingers with the forefingers pressing against a surface of the cap and the thumb acting on the actuating plunger. Air inlets (15) may be located around the mouthpiece (9).

Description

Inhaler

Field of Invention

The present invention relates to a new kind of inhaler.

Backaround of the Invention

Inhalers for the delivery of medication to the lungs have been available for a number of years. They are most commonly used by asthmatics to alleviate the symptoms of their condition, but may also be used in the treatment of other conditions, for example Chronic Obstructive Pulmonary Disease (COPD). Inhalers also provide a convenient means of delivering a medicament systemically by way of absorption through the lungs.

The number of asthma and COPD sufferers has progressively increased throughout the world over recent decades. While no absolute cure is currently available for these conditions, the use of inhalers provides a growing number of people with relief from these and other respiratory disorders.

Inhalers are usually carried by their users at all times, since regular dosing of medication is often required throughout the day and asthmatics never know when they may suffer an asthma attack. It is therefore important that the inhalers are as comfortable and practical as possible both in use and when being carried.

One of the most familiar inhalers currently on the market is the EvohalerTM, manufactured by the GlaxoSmithKline company. This inhaler consists of a plastic outer chamber, which houses a pressurised aluminium alloy canister. The medication is contained within the canister. The base of the outer chamber has a hollow, horizontal protrusion, which serves as the mouthpiece. The mouthpiece end has a removable dust cap that serves to keep the mouthpiece clean when not in use, whereas the other end of the chamber is open to allow for the intake of air.

Each alloy canister contains 80-200 metered doses, providing, for example, 100 micrograms of VentolinTM (Salbutamol) per dose for the treatment of asthma. Canisters may contain different medications depending on the clinical condition being treated. A further example of a medication often used in inhalers to treat asthma is Becotide_ (Beclometasone dipropionate). Canisters and inhalers are often colour coded. For example, VentolinTM canisters and inhalers are coloured blue, whereas BecotideTM canisters and inhalers are coloured orange.

A conventional inhaler of the type generally available is shown in Figure 7, the arrows indicate the direction of airflow into the open top of the inhaler when the user inhales through the mouthpiece.

In order to deliver the medication to the lungs with a conventional inhaler, the user first removes the mouthpiece and may also blow-out the device to remove any dust or contaminants that may have found their way in through the open end of the chamber.

Holding the inhaler vertically, the user places their lips around the mouthpiece. The user then depresses the pressurised canister in order to release a metered dose of medication into the mouthpiece while simultaneously inhaling the medication into the lungs.

The act of inhalation causes air to enter the top of a conventional inhaler, pass down through the main outer chamber of the inhaler and mix with the medication spray. A vacuum would result during inhalation if there is no free passage of air between the canister and the outer chamber. Thus, conventional inhalers remain open at one end all of the time. However, this design makes conventional inhalers vulnerable to contamination by dust, pollutants and micro-organisms.

Inhalers according to the above description have been used for a number of years.

Nevertheless, they have a number of significant drawbacks. Foremost of these drawbacks is the fact that the mouthpiece caps are completely detachable and are easily lost, thereby increasing the risk of contaminants entering the chamber.

Conventional inhalers can also be awkward to use. Inhalers of the type described above are held vertically and require a reasonable amount of force to operate. This action can be difficult for smaller hands and the smooth concave top of the canister can be slippery.

Furthermore, the mouthpiece of inhalers of the type described protrudes from the main outer chamber of the inhaler producing an 'L' shape. This mouthpiece protrusion and the general angular design are uncomfortable when the inhaler is being carried, as is often the case, in a trouser pocket.

Another drawback is that because conventional inhalers are always open at one end, they are prone to contamination by dust, pollutants or microorganisms. The presence of these contaminants in an inhaler is to be avoided since these may aggravate the very symptoms that the medication is trying to control. Although, as mentioned above, experienced inhaler users will attempt to clean-out their inhalers before use, such fastidiousness is not always practically possible, for example, when an asthmatic is suffering an asthma attack or when the inhaler is being used by a child.

A further drawback is that because of the 'L' shape of the inhalers described above, the emission aperture is located at the juncture between the base of the outer chamber and the mouthpiece. As a result of this arrangement, a significant proportion of the medication is often sprayed onto the inner surfaces of the mouthpiece rather than directly into the user's airways.

The present invention is a new kind of inhaler designed to overcome these drawbacks and offer further improvement.

Obiect of the Invention It is an object of the present invention to provide an inhaler that is hygienic, compact, comfortable and practical.

Summary of the Invention

In a first broad aspect of the present invention there is provided an inhaler, comprising an actuating plunger, a mouthpiece and a hinged mouthpiece cap, such that with the cap in the open position the inhaler is either, adapted to be held between the thumb and the forefingers with the thumb pressing at least partially against a surface of the cap and the forefingers pressing against the actuating plunger, or adapted to be held between the thumb and the forefingers with the forefingers pressing against a surface of the cap and the thumb pressing against the actuating plunger.

There is further provided an inhaler according to the first broad aspect of the present invention, wherein the hinged mouthpiece cap includes a recess which accommodates the mouthpiece when the cap is in the closed position. Preferably, the upper surfaces of the mouthpiece and the recess are sloped to allow for a close fit between the mouthpiece and the hinged mouthpiece cap.

There is further provided an inhaler according to the first broad aspect of the present invention, wherein the actuating plunger fits snugly within the main body of the inhaler.

Air inlet apertures positioned adjacent to the mouthpiece allow air to freely circulate through the mouthpiece during inhalation of the medication.

In one embodiment of the invention the medication is contained within a replaceable pressurised canister.

In a further embodiment of the invention, the emission aperture, from which the medication spray is released, is positioned within the mouthpiece.

Definitions Definitions of terms within the context of this document are detailed below.

The term "inhaler" includes any kind of device that is used to deliver a medicament to the respiratory tract, oral cavity or oropharynx by way of inhalation.

The term "canister" includes any kind of medicament- or drug-containing pressurised cartridge or canister suitable for use with an inhaler. The canister may be a permanent component of the inhaler, which is perhaps refillable, or may be a replaceable canister.

Examples of medicaments currently used in such canisters include VentolinTM (Salbutamol) and BecotideTM (Beclometasone dipropionate). The canisters may also contain medicaments other than small molecular weight pharmacetucial compounds, for example nucleic acids for gene therapy products, or proteins, for example monoclonal antibodies.

The term "micro-organisms" includes bacteria, viruses, fungi and all other microscopic life forms.

General Descrintion of the Invention Inhalers of the present invention overcome the limitations of conventional inhalers by the incorporation of a hinged mouthpiece cap, arranged in such a way that it provides not only a more hygienic inhaler, sealed against contaminants and micro-organisms when not in use, but also a novel and inventive means of holding an inhaler and delivering medication therefrom.

In one embodiment of the present invention, the cap in the open position provides a stable surface against which the user places their thumb. The inhaler is of a size that fits comfortably within the hand so that the forefingers can reach to the other end of the device and be brought to rest against the actuating plunger. When so held, inhalers of the present invention are very stable and comfortable in use, thereby providing an easy and convenient means of drug delivery.

In a less preferable embodiment, the inhaler can be held with the forefingers against the hinged mouthpiece cap and the thumb against the actuating plunger.

With the cap in the closed position, the inhaler has a smooth, cylindrical shape which is more comfortable to carry, for example in a trouser pocket, than a conventional inhaler.

In order to actuate drug delivery, while holding the inhaler, the user places their lips around the mouthpiece and simply moves their forefingers towards their thumb in a clasping motion. In one embodiment of the present invention, stability for said movement is provided by the thumb pressing against the inner surface of the hinged mouthpiece cap and the area directly beneath the mouthpiece. As the forefingers move towards the thumb they press against the actuation plunger causing it to move inwards, which in turn exerts a force onto the canister pushing the canister nozzle into the nozzle housing. When the pressure exerted by the actuation plunger on the canister nozzle reaches a critical point it causes a dose of drug or medicament to be aerosolised and released from the canister nozzle. The drug or medicament then passes through the emission aperture in the nozzle housing and out through the mouthpiece. By simultaneous inhalation, the user receives a dose of drug or medicament into their lungs.

Free passage of air into the inhaler and out through the mouthpiece is provided by inlet apertures in the main chamber of the inhaler positioned on either side of the mouthpiece.

Inhalers of the present invention can be made compatible with those canisters currently on the market, the process by which pressure is applied to the canister nozzle causing the medication to be aerosolised and released from the emission aperture remaining the same. Unlike conventional inhalers however, the canister when used in inhalers of the present invention is neither visible when the inhaler is in use nor when the hinged mouthpiece cap is closed. As well as helping to prevent contamination of the canister by dust or micro-organisms, this arrangement is more attractive in form and appearance.

It is anticipated that inhalers of the present invention are manufactured from the same material as those currently on the market, for example, polypropylene. However, the inhalers could be made from any material, which is sufficiently rigid, for example, stainless steel, titanium, or any other suitable metal or plastic.

List of Drawings Figure 1. Side and end views of an inhaler of the present invention with the hinged mouthpiece cap in the closed position.

Figure2. Side views of an inhaler of the present invention with the hinged mouthpiece cap in a partially open position in the upper drawing and fully open in the lower drawing.

Figure 3. Side and end views of an inhaler of the present invention with the hinged mouthpiece cap in the open position.

Figure 4. Side view of the actuating plunger of the present invention, showing the convex surface of the actuating plunger recess, shaped to fit against the concave top of a replaceable pressurised canister. Lower drawing depicts how the mouthpiece cap recess and the mouthpiece can be shaped to allow for the opening and closing of the cap.

Figure 5. Underside, cross sectional views of an inhaler of the present invention, which include actuation plunger and canister detail. The lower drawings show an end view of the actuating plunger and an underside view of an inhaler of the present invention.

Figure 6. Illustration of how an inhaler of one embodiment of the present invention is held between the thumb and forefingers in use. Arrows 'A' indicate the direction in which the actuating plunger is pressed in use, whereas arrows 'B' indicate the direction of flow of spray from the mouthpiece.

Figure 7. Side view of a conventional inhaler with arrows indicating the passage of air.

Detailed Descrintion of the Invention with Reference to the Drawings There now follows a detailed description of one embodiment of the present invention with reference to the above list of Figures 1 to 6.

In the embodiment shown in the Figures, the inhaler is cylindrical in shape when in the closed configuration. Main chamber 1 forms the central portion of the inhaler, while hinged mouthpiece cap 2 and actuating plunger 3 form the ends, Figure 1. Main chamber 1 and hinged mouthpiece cap 2 have flattened sections 4 on their undersides, and similarly actuating plunger 3 has a corresponding flattened section 5, Figures 1 and 5. Hinged mouthpiece cap 2 is attached to main chamber 1 by hinges 6. Hinged mouthpiece cap 2 further comprises opening tab 7 that sits slightly proud of the otherwise smooth upper surface of the inhaler. Opening tab 7 facilitates moving hinged mouthpiece cap 2 from the closed position to the open position. Actuating plunger 3 further comprises indentations 8, sculpted to accommodate the contours of the forefingers, thereby making the inhaler more comfortable in use. The outer surface of actuating plunger 3 may also be textured, or coated with a tactile grip, for example a synthetic rubber material, in order to provide extra grip for the forefingers and to prevent slippage.

Main chamber 1 and hinged mouthpiece cap 2 can be colour-coded in the same way as those inhalers currently available, thereby identifying an inhaler of the present invention as containing a particular type of medication.

The end of main chamber 1 that is connected by means of hinges 6 to hinged mouthpiece cap 2 further comprises an elongated hollow protrusion, which serves as mouthpiece 9, Figures 2. Mouthpiece 9 is shaped with a sloping top edge. This is because the inner surfaces of hinged mouthpiece cap 2 fit closely over mouthpiece 9 when moving the cap between the open and closed positions. The 180 arc of rotation of hinged mouthpiece cap 2 determines the angle of the slope on the top edge of mouthpiece 9. Nevertheless, the shape of mouthpiece 9 is comfortable in use and provides extra purchase for the top lip of the mouth.

In an alternative embodiment, the mouthpiece could be curved rather than straight. In this embodiment the inhaler could be held vertically or at an angle, with the thumb pressing against the actuating plunger and the forefingers pressing against a surface of the hinged mouthpiece cap. The user would then actuate the inhaler by pressing the actuating plunger with their thumb. The pressure of the forefingers against the hinged mouthpiece cap would provide stability during inhalation.

In the embodiment shown in Figure 2, hinged mouthpiece cap 2 pivots on hinges 6 through 180 when moving to and from the open position. As such, when the inhaler is in the fully open position ready for use, the edge of main chamber 1 and the inner surface of hinged mouthpiece cap 2 are in vertical alignment with their flattened sections 4 mated. In this position, the contact area 10 upon which the thumb exerts pressure during use of the inhaler includes both the inner surface of hinged mouthpiece cap 2 and the surface of main chamber 1 below mouthpiece 9. These surfaces that bridges the area around the open hinge may be textured 14 to enhance grip, Figure 3.

This whole arrangement ensures that the inhaler remains stable in use as a reasonable amount of force is required to actuate the inhaler.

Hinged mouthpiece cap 2 is held in place around mouthpiece 9 and against the main chamber 1 by cap-stay mouldings 11 and 12, Figures 2 and 3, and clicks shut when moved into the closed position.

Hinged mouthpiece cap 2 further includes recess 13, which accommodates mouthpiece 9 when the inhaler is in the closed position, Figures 3 and 4. Cap-stay mouldings 11 and 12 are provided on the inner surface of recess 13 and the upper surface of mouthpiece 9 respectively ensuring that hinged mouthpiece cap 2 holds fast in the closed position until pressure is applied to opening tab 7 when moving cap 2 from the closed to the open position.

Main chamber 1 further comprises inlet apertures 15 either side of mouthpiece 9, Figure 3. In use, as medication is released into mouthpiece 9 through the emission aperture 16, the user simultaneously inhales. The purpose of inlet apertures 15 is to allow for the free flow of air into main chamber 1 and out through mouthpiece 9 during inhalation of medication. As the air enters through inlet apertures 15, it mixes with the medication as it is released from the emission aperture 16 and is inhaled through mouthpiece 9. Raised sections 17, mirroring the shape of inlet apertures 15, are incorporated into the moulding of the inner surface of hinged mouthpiece cap 2. When hinged mouthpiece cap 2 is in the closed position, raised sections 17 are partly received by inlet apertures 15, further preventing dust, pollutant and micro-organism penetrating into the inhaler.

Hinged mouthpiece cap 2 thus completely covers mouthpiece 9 and inlet apertures 15 when the inhaler is not in use.

Since actuating plunger 3 fits snugly within main chamber 1, Figure 4, there would be no free passage of air in the absence of inlet apertures 15 and the user would be unable to inhale the medication. The provision of inlet apertures 15 therefore solves this problem and allows free passage of air into main chamber 1, thus preventing the formation of a vacuum, which would result if there was no means of allowing air to enter main chamber 1 during inhalation of medication. Inlet apertures 15 are hidden behind hinged mouthpiece cap 2 when in the closed position and are only visible when the inhaler is in use, thereby limiting exposure of the inner surfaces of the inhaler to contaminants.

Main chamber 1 also serves as a sleeve, into which actuating plunger 3 can slide.

Actuating plunger 3 and main chamber 1 can be precisely made so that the actuating plunger fits snugly within the main chamber, Figures 4 and 5.

Actuating plunger 3 includes recess 18 with a convex inner surface 19 at the end of the recess, Figures 4 and 5. The purpose of recess 18 is to accommodate a replaceable pressurised canister 20. Convex inner surface 19 is so shaped to fit against the concave top of a replaceable pressurised canister 20 compatible with the present invention.

To insert a canister 20, the user simply withdraws actuation plunger 3 from main chamber 1 and inserts the canister into recess 18. Removal of actuation plunger 3 from main chamber 1 also provides the user with an opportunity to undertake a thorough cleaning of the inside of the inhaler, if required. Actuation plunger 3 and the canister are then reinserted into main chamber 1. As a consequence of flattened sections 4 and 5, there is only one way of fitting actuating plunger 3 into main chamber 1. Once actuating plunger 3 and canister 20 are inserted in place, canister nozzle 21 rests inside nozzle housing 22 within mouthpiece 9, Figures 4 and 5.

The emission aperture 16 is located on one side of nozzle housing 22 at the centre of mouthpiece 9, Figures 3 and 4. This is an improved positioning over conventional inhalers where the emission aperture is placed further back from the mouthpiece opening. By positioning the emission aperture 16 at the centre of mouthpiece 9, it is situated closer to the mouth, resulting in a more effective delivery of the medication to the user with less of the spray ending up on the inside of the chamber and mouthpiece as commonly occurs with conventional inhalers.

In use, the inhaler of one embodiment of the present invention is held horizontally between the forefingers and the thumb of one hand, Figure 6, with the forefingers pressing against actuating plunger 3 and the thumb pressing against the thumb contact area 10 around hinges 6. The user then places their lips around mouthpiece 9 and actuates the inhaler by depressing actuating plunger 3 in the direction of movement shown by the arrows 'A', thereby simultaneously pushing canister 20 into main chamber 1. Once actuating plunger 3 and canister 20 have moved a sufficient distance, a dose of medication is released from emission aperture 16 in a spray. As the user simultaneously inhales, air flows into main chamber 1 through inlet apertures 15 adjacent to mouthpiece 9. As the air enters main chamber 1, it mixes with the drug and is inhaled into the lungs through mouthpiece 9. On release, the canister's inbuilt return spring pushes both canister 20 and actuating plunger 3 back out into the starting position.

In alternative embodiments, the inhaler could be held vertically or at an angle.

It is anticipated that inhalers according to the present invention could be made in alternative styles and colour schemes. Users could therefore purchase the inhaler in a particular style or colour to suit their tastes and simply insert an appropriate type of canister within it according to their own medical needs. Inhalers of the present invention could thus be personalized and provide a means for their users to express their personality.

Component List 1. Main chamber 2. Hinged mouthpiece cap 3. Actuating plunger 4. Flattened sections on main chamber 1 and cap 2 5. Flattened section on actuating plunger 3 6. Hinges 7. Opening tab on cap 2 8. Indentations for forefingers on actuating plunger 3 9. Mouthpiece 10. Thumb contact area 1 1. Cap-stay moulding in cap recess 13 12. Cap-stay moulding on mouthpiece 9 13. Recess for mouthpiece 9 in cap 2 14. Texture on thumb contact area 10 15. Inlet apertures 16. Emission aperture for sprayed medication in canister nozzle housing 22 17. Raised sections to fit into inlet apertures 15 18. Recess in actuating plunger 3 19. Convex inner surface of recess 18 20. Pressurised canister containing medication 21. Canister nozzle 22. Nozzle housing for canister nozzle in mouthpiece 9

Claims

Claims An inhaler, comprising an actuating plunger, a mouthpiece and a

hinged mouthpiece cap, such that with the cap in the open position the inhaler is either, adapted to be held between the thumb and the forefingers with the thumb pressing at least partially against a surface of the cap and the forefingers pressing against the actuating plunger, or adapted to be held between the thumb and the forefingers with the forefingers pressing against a surface of the cap and the thumb pressing against the actuating plunger.
2. An inhaler as claimed in claim 1, wherein the hinged mouthpiece cap includes a recess, which accommodates the mouthpiece when the cap is in the closed position.
3. An inhaler as claimed in claim 2, wherein the upper surfaces of the mouthpiece and the recess are sloped to allow for a close fit between the mouthpiece and the hinged mouthpiece cap.
4. An inhaler as claimed in any one of claims 1 to 3, wherein the actuation plunger fits snugly within the main body of the inhaler.
5. An inhaler as claimed in any one of claims 1 to 4, wherein air inlet apertures are positioned adjacent to the mouthpiece.
6. An inhaler as claimed in any one of claims 1 to 5, wherein the medication is contained within a replaceable pressurised canister.
7. An inhaler as claimed in claim 6, wherein the actuating plunger includes a recess to accommodate the canister.
8. An inhaler as claimed in claim 7, wherein the recess that accommodates the canister has a convex surface to receive a canister having a concave top.
9. An inhaler as claimed in any one of claims 1 to 8, wherein an emission aperture is positioned within the mouthpiece.
10. An inhaler substantially as described herewith by reference to the drawings 1 to 6.