Several million people worldwide have chronic conditions, and millions more will develop them as the older adult population grows. A major part of these people have chronic lung diseases, like asthma. This trend will continue in the future. Traditionally, one of the means for therapeutic intervention for patients with chronic lung diseases has been large inhalator devices at hospitals or other facilities, which represented and still represent one of the possibilities for local delivering of a specific medication to the patient. A disadvantage with this kind of aerosol distribution devices are that they are large and can most often only be used stationary. During the last decades other types of mobile (pocket) aerosol inhalation devices emerged making it possible to have a certain dose of medication available when needed.

Aerosol inhalation devices are preliminary used for local application of pharmaceutical preparations to the lower part of the respiratory tract. Inhalation, the process by which gas is drawn into the lungs through the trachea, delivers the pharmaceutical preparation locally and directly to the place of treatment.

Nowadays inhalation administration of aerosols is most common for treatment of pulmonary diseases. An aerosol, which is the preferred administration form for treating pulmonary diseases, is a colloidal dispersion of a solid or liquid in a gas. The commonly used aerosol inhalators contain an inert propellant liquefied under pressure. Using this pressure the pharmaceutical preparation conveys the medicament directly into the mouth and further on to the lower respiratory tract. This kind of local administration of such a pharmaceutical preparation, gives more rapid results compared to systematic administration of the same pharmaceutical preparation.

Mobile (pocket) aerosol inhalation devices used for administration of a pharmaceutical preparation must have certain distinctive characters that make them easy to handle, visible and accessible under all kind of circumstances. First of all, it is important that such an inhalator is simple and functional with regard to transportation as well as it is important that this inhalation device is easy to use. Additionally, it is very important to achieve uniform spray properties that should result in a fine spray. The reason for this is that larger spray particles can remain in the oral cavity or the aspiratory attract. Also

this is a reason to make in inhalator as simple as possible. Another fact is that it is often necessary to use the inhalator in the evening or at night due to sudden breathing difficulties. Usual inhalators are not marked with certain materials which can make it difficult to find these devices within a short time period, when needed.

There are a lot of inhalators on the market, which have been there for a long time. Such known inhalators are usually one or two types. The first type includes a cap with a mouthpiece, which can be retracted into the inhalator body when the inhalator is not in use and extracted when needed. The reason for this structure is mainly to obtain more hygienic conditions. The second type comprises a cover device on a fixed mouth peace, which is in connection with an aerosol container. The aerosol container, when being opened, releases a gas that, in combination with a pharmaceutical preparation, constitutes an aerosol in spray form and transfers said combination through the mouthpiece directly into the oral cavity and further on to the lower respiratory tract.

The purpose of the mouthpiece as such, is to convey the spray including pharmaceutical preparation direct into the area to be treated to avoid loss of the pharmaceutical preparation to the surrounding air as well as to avoid contamination from the outside environment. This type of inhalator is represented by the present invention and will be explained more detailed in the following description.

As mentioned above, the recognition of said inhalator in the darkness is very important in case of sudden breathing difficulties. Most of the time an immediate use of the inhalator is the only way to relieve or stop said breathing difficulties. Each year many patients suffering from pulmonary diseases are affected of such a problem. The inventor of the present invention recognised this problem and, by using a photoluminescent material, which is both safe and does not contain either radioactivity or phosphorous materials, this issue can be solved both with respect to economic and health matters. The inhalator of the present invention can be disposable, or it has optionally multi use.

Photoluminescence is often used for blood irradiation and finds a lot of applications in laser technology. Other applications are in the compound-semi-conductor manufacture business as well as in photoluminescence spectroscopy for analysis of surfaces and interfaces. Actually, luminescence is the emitting of light by substance for any reason other than a rise in its temperature. In general, atoms of substances emit photons of electromagnetic energy when they return to the ground state after having been in an excited state. The causes of the excitations are various. If the exciting cause is a

photon, the process is called photoluminescence. In the present invention this kind of illuminating material is used to make the inhalator device according to the present invention visible in the darkness.

Conventional inhalation devices, such as described in US 4,137,914 provide for an aerosol inhalation device, which is designed to use a capsule having a single dose of medication and the propellant. The device includes a hollow needle, which perforates the capsule to release the medication. The capsules used with the revise include a single dose of medication and an appropriate quantity of propellant.

Another description, as shown in US 4,641,644, shows an aerosol inhalation device in pocket-size which has one dosage dispending position and one storage position, and which comprises a two-part telescoping deceleration chamber with rectangular cross- section and a socket for an exchangeable aerosol container. The above-mentioned patent consists of several parts, which represent a difficult construction, and is as such probably more expensive with respect to production costs compared to the inhalator device of the present invention. Cheaper production costs will thus lead to lower costs for the consumer.

Additionally, another patent (US 4,969,455) shows an inhalator for use with aerosol containers of the type with an extendable and retractable mouth piece which comprises a tubular body intended to receive the aerosol container and having in its upper portion a coloured and a hinge pin for the delivery mouth piece. The delivery mouthpiece is provided on one side with the hinge, which mates with the hinge pin, which is fixed to the tubular body. The inhalator device represented by this patent is much to complicated for having single use features and additionally no retracting or extracting mouthpiece is needed for the inhalation device of the present invention.

With basis in the above-mentioned information it is evident that it is desirable to provide and that there is a need for an inhalation device that is simple and functional with regard to the construction of said device. Thus one of the most obvious advantages with the inhalator device of the present invention are the very low production costs made possible by a simple construction providing easy to use properties.

Additionally, there is a need for marking said inhalation device to make these devices visible in the darkness. Prior art inhalation devices show similar constructions but none

of them has both the combination of this new type of inhalation apparatus together with said marking.

Another important advantage of the inhalator device of the present invention is that this device is very easy to recycle due to the simple construction as well as the materials used for production of said device.

Summary of the invention In accordance with the invention, there is provided an inhalator device comprising an inhalator housing consisting of a central housing part, housing a container comprising an aerosol, and a laterally situated inhalation part on the lower part of said inhalator housing for consuming said aerosol and a recognition part on said inhalator housing for recognizing said inhalator device in darkness as well as optionally a cover device which can be used to close and open said laterally situated inhalation part of said inhalator device.

In a preferred embodiment the recognition part is comprised of a luminous material, preferably a photoluminescent material.

In a most preferable embodiment the photoluminescent material is PGS-F-10 or PGS-F- 20. Said materials are further explained in the following technical documentation.

Said recognition part is optionally only partially present on the side of the opening of said inhalator part being laterally situated to said inhalator device having a shape enabling immediate recognition of said opening in the darkness.

In accordance with a further aspect of the invention, the above-mentioned shape is a V- shape limited by both ends of said recognition part.

Another embodiment of the present invention is that the central housing part comprises a distribution structure which is located centrally on the bottom and on the inside of said central housing part and which, in connection with said container, is responsible for distribution of said aerosol.

Another embodiment of the inhalator device of the present invention is that said distribution structure can optionally be a mounted distribution structure or a moveable and optionally exchangeable distribution structure.

For a better understanding of the present invention, reference is made to the following description, which must be seen in conjunction with the enclosed drawings, and its scope will be determined by the appended claims.

Brief description of the Drawings Figure 1 is a cross-sectional view of an inhalation device in accordance with the invention.

Figure 2 shows the inhalator's total appearance from the bottom and the top as well as from both sides.

Figures 3a and 3b show the preferred embodiment of the distribution structure of the inhalator device of the present invention in a cross-sectional view as well as in a front view seen from the side of the opening of the laterally situated inhalation part.

Description of the invention Referring to figure 1, there is shown an inhalator device in a cross-sectional view along the line AA. The drawing shows said inhalator device comprising an inhalator housing consisting of a central housing part (1) housing a container (2) which comprises an aerosol, and a laterally situated inhalation part (3) with a mouthpiece on the lower part of said inhalator housing for consuming said aerosol. The drawing additionally reveals the recognition part (4) on said inhalator housing for recognizing said inhalator device in the darkness. Additionally, a cover device (not shown) can optionally be used to close and open said laterally situated inhalation part (3) of said inhalator device.

As can been seen from figure 1, said central housing part (1) comprises a distribution structure (5) which is located centrally on the bottom and on the inside of said central housing part (1) and which, in connection with said container (2), is responsible for distribution of an aerosol. This distribution structure (5) can be adjusted to the aerosol container, but it is preferably a tube-like hollow structure, with an opening on the top continuing in the centre of said tube as well as with an opening at the lower part of said

structure pointing towards the laterally situated inhalation part (3), for punctuating the aerosol container and further leading a concentrated amount of aerosol through said distribution structure (5) and releasing the aerosol via said inhalation part (mouthpiece) into the patient's mouth. Said distribution structure (5) can be mounted to provide cheap and disposable inhalators or optionally being a moveable and/or exchangeable structure together with a stabilizing device for multi use purposes. It will be evident to those skilled in the art that the same results may be achieved if the distribution structure (5) is movable or not, because both methods can be used individually to effectuate puncture of the aerosol container.

Additionally the sidewall of said central housing part (1) is, if necessary, provided with receiving and leading members on the inside of said central housing part to effectively stabilize the container comprising the aerosol in the central housing part (1). This embodiment is possible, but not necessary due to the fact that several different aerosol containers with different measurements can be used together with the inhalator device of the present invention.

As mentioned above said inhalator device comprises a recognition part (4) which totally covers the upper and/or medium part of said central housing part (1), but which is preferably only partially present on the side of the opening of said inhalator part (3) being laterally situated at said inhalator device having a shape enabling immediate- recognition of said opening in the darkness. Preferably, the shape of this recognition part is a V-shape limited by both ends of said recognition part where the smaller part of this"V-shape"points towards the opening of said inhalator part (3) being laterally situated at said inhalator device. This marking gives a clear indication regarding the handling of said inhalation device.

More detailed said recognition part (4) is comprised of a luminous material, preferably a photoluminescent material. Photoluminescent materials are safe products and contain neither radioactive nor phosphorous materials. The products contain a natural substance called aluminate crystals. When exposed to artificial light or day light for a short time, the material absorbs and stores light energy.

In darkness the light is emitted as a bright glow lasting over a period of several hours.

Further exposure to light for a few minutes will recharge the material and make it ready for further use.

The usual application of the photoluminescent inhalator of the present invention is, as mentioned above, to charge the inhalator before darkness. Usual charging times are: Daylight: 5 minutes Fluorescent tube: 10 minutes Fluorescent lamp: 15 minutes Incandescent lamp: Unsuitable The following materials have been developed by the applicant in three different qualities to be used as the photoluminescent material of the present invention: PGS-F-4 PGS-F-10 PGS-F-20 The quality of these products makes the material suitable for use as an inexpensive and totally reliable escape route marking system.

The qualities of PGS-F-10 and PGS-F-20, which are mainly important for the present invention, are described on the next pages in the following technical documentation with a view of construction, light and charging specifics.

Figure 2 shows said inhalator device from a central view as well of both sides revealing the mentioned recognition part (4) in a most preferable embodiment of the present invention as well as the upper top of an inserted aerosol container (2). Additionally this figure shows the inhalator device of the present invention from the bottom as well as from the top showing the inside of said inhalator device, which houses the aerosol container.

Figures 3 a and 3b show the preferred embodiment of the distribution structure (5) of the inhalator device of the present invention in a cross-sectional view as well as in a front view seen from the side of the opening of the laterally situated inhalation part.

Additionally the central housing part (1), the inhalation part (3) as well as the preferred embodiment of the recognition part (4) can be seen in these figures.

It will be evident to those skilled in the art that the measurements and the proportions of the distribution structure as well as of the other parts of the inhalator device can vary

due to different aerosol containers making said inhalator device suitable for many types of aerosol containers as well as due to different modes of use.

The material of the inhalator device of the present invention is preferably plastic due to the low weight and partial stability of such a material. Said inhalation device is most simply produced by conventional injection moulding of a plastics material such as for example HD-polyethylene (HE7028 from Borealis AB/Ashland Sweden AB). The polyethylene preferably used for production of the inhalator device of the present invention is a natural HD polyethylene with high melt index and very narrow molecular weight distribution, produced in a low-pressure gas phase process. The material is characterized by excellent flow properties, minor distortion and high stiffness.

The production costs for this device are very low and as such said inhalator device has both single and multiple use properties. Additionally it is very important to notice that the inhalator of the present invention is very easy to recycle and, when burned, for example, only a few parts carbon dioxide as well as water remains. With regard to the protection of the environment, this is a very important feature of the inhalator device of the present invention.

To activate the inhalation device, a patient places an aerosol container (2), fixed by said receiving and leading members inside said central housing part (1). Afterwards, the patient puts pressure on the top of said container to press the container on the mounted distribution structure (5) to release said aerosol. Alternatively (not shown), it is possible to place said aerosol container inside the central housing part (1) and, by using a moveable needle on a mounted stabilization structure, it is possible to drive said needle through a central opening to puncture the container and therefore release its contents in aerosol through said mounted stabilization structure and out of the laterally situated inhalation part (3).

The inhalator according to the present invention provides thus both the immediate recognition of the inhalator device in the darkness as well as the immediate recognition of the inhalation part (3) at a lower part of a usual inhalator which is shaped as a mouth piece and which, together with the use of said aerosol container by punctuating it, is necessary to transfer the aerosol into the patient's mouth and further on into the respiratory tract.

While there has been described what are believed to be preferred embodiments of the invention, those skilled in the art will recognise that other and further modifications may be made thereto, without departing from the spirit of the invention, and it is intended to claim all such embodiments as followed within the true scope of the invention.

Technical documentation of the photoluminenscent material.

The abbreviations PGS-F-10 or PGS-F-20 (Prolink-guideline-system) used in the description of the inhalator device of the present invention are type designations of the product from the producer.

Additionally a Type Approval Certificate (D. N. V. E5151) (enclosure 1) is enclosed to give more information regarding the luminating materials used together with the inhalator device of the present invention.

1. Ambient charging light (lux) opposite luminance All measurements are carried out in a light laboratory with a special light source in accordance with DIN 67510 standard test method. The product luminance will therefore vary depending on the light source available on the location where installed.

Bear in mind that the charging light type can greatly affect the resulting luminance.

In the graphics below the material was exposed to fluorescent light type Lumilux Daylight L36/11-860. The graphics represent the two different materials and their luminance after 60 minutes when exposed to the above light source at different Lux values.

The luminance is measured on the product surface.

Photoluminescent material Type PGS-F-10 217/30-3152 (DIN 67510)

Photoluminescent material Type PGS-F-20 362/50-4760 (DIN 67510) 2. Degree of luminance against time in minutes Regarding the light density for this kind of photoluminescent materials, the following properties can be given: PGS-F-10 Photoluminescent properties 217/30-3152 according to DIN 67510 Luminance after 10 minutes 217, 0 mcd/m2 Luminance after 30 minutes 67,3 mcd/m2 Luminance after 60 minutes 30,5 mcd/m2 Luminance after 120 minutes 13,4 mcd/m2 Luminance after 3152 minutes 0,3 mcd/m2 "Tabell 3"

PGS-F-20 Photoluminescent properties 362/50-4760 according to DIN 67510 Luminance after 10 minutes 362,0 mcd/m2 Luminance after 30 minutes 111,7 mcd/m2 Luminance after 60 minutes 50,6 mcd/m2 Luminance after 120 minutes 22,3 mcd/m2 Luminance after 4760 minutes 0,3 mcd/m2 "Tabell 4"