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Title:
DISPOSABLE INHALATION SUBSTANCE APPLICATOR AND FACE MASK WITH SUCH AN APPLICATOR
Document Type and Number:
WIPO Patent Application WO/2023/169613
Kind Code:
A1
Abstract:
The subject invention is a disposable applicator (1) of an inhalation substance and a face mask having such an applicator (1), wherein the disposable applicator (1) includes an inhalation substance source (2) and an impregnation element (3) in contact with the inhalation substance source (2), the impregnation element (3) being breathable and adapted to absorb the inhalation substance (4). The inhalation substance source (2) includes the first capsule (5) and the inhalation substance (4) disposed within the first capsule (5), wherein the disposable applicator (1) further includes a heating element (6) for heating the impregnation element (3) in contact with the first capsule (5) over a majority of the surface of the first capsule (5).

Inventors:
DOHNAL JAROSLAV (CZ)
JANOŠTÍK ZDENĚK (CZ)
Application Number:
PCT/CZ2023/000008
Publication Date:
September 14, 2023
Filing Date:
March 07, 2023
Export Citation:
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Assignee:
DOHNAL JAROSLAV (CZ)
JANOSTIK ZDENEK (CZ)
International Classes:
A41D13/11; A61J3/07; A61K9/00; A61M15/00; A61M16/10; F24V30/00
Domestic Patent References:
WO2014045025A22014-03-27
Foreign References:
EP3892119A12021-10-13
US20150313286A12015-11-05
US4790307A1988-12-13
US20170239428A12017-08-24
Attorney, Agent or Firm:
ING. PAVEL NÁDVORNÍK S.R.O. (CZ)
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Claims:
PATENT CLAIMS A disposable applicator (1) of an inhalation substance comprising an inhalation substance source (2) and an impregnation element (3) in contact with an inhalation substance source (2), the impregnation element (3) being breathable and adapted to absorb an inhalation substance (4), characterised in that wherein the inhalation substance source (2) comprises a first capsule (5) and the inhalation substance source (4) contained within the first capsule (5), and further comprising a heating element (6) for heating the impregnation element (3) In direct contact with the impregnation element (3), wherein the impregnation element (3) is in contact with the first capsule (5) over a majority of the surface of the first capsule (5). The disposable applicator (1) of the inhalation substance according to claim 1 , characterised in that the heating element (6) comprises an exothermically crystallising substance (7) and an activator for initiating crystallisation (8) for activating crystallisation of the exothermically crystallising substance (7). The disposable applicator (1) of the inhalation substance according to claim 2, characterised in that the heating element (6) further comprises a second capsule (9), wherein the activator for initiating crystallisation (8) is disposed inside the second capsule (9). Disposable applicator (1 ) for an inhalation substance according to claims 1 to 3, characterised in that it is connected to a mouthpiece (10), the mouthpiece (10) being oriented towards the impregnation element (3). Face mask (11), characterised in that it comprises a disposable applicator (1) for the inhalation substance according to claims 1 to 3. The face mask according to claim 5, characterised in that the face mask (11) comprises at least two breathable layers, wherein the disposable applicator (1) of the inhalation substance is disposed between the two breathable layers of the face mask (11).
Description:
Disposable inhalation substance applicator and face mask with such an applicator

Field of the Invention

The invention relates to a disposable applicator for inhaling substances at elevated temperatures, in particular for use in combination with a mouthpiece or as an element implemented in a face mask, such as a face mask or respirator.

Background of the invention

In the present state of the art, a number of inhaler devices are known for inhaling medicinal substances or essences used, for example, in the treatment of asthma, bronchitis or other respiratory diseases. Thermal conditions are very important for the optimum properties of inhalation substances, according to which inhalation can be distinguished into cool (hypothermal), indifferent (isothermal) and warm (hyperthermal). In cool mist inhalation, the vapour temperature is close to the ambient temperature and there is no need to heat the inhalation substance, but in indifferent and warm mist inhalation, it is advisable to heat the inhalation substance to body temperature or higher to increase the blood supply to the mucous membranes. For the purpose of warm mist inhalation, currently mainly electric heating of the inhaled substance is used. The disadvantages of such heated inhaler devices and instruments are often their larger size, weight, cost, dependence on a power source and the spatial limitation of use in healthcare facilities. When heating electric inhalers without mains power, the availability of another portable power source (battery, power bank) is required.

One solution for portable inhaler devices is described in a patent file W020061 12798 A1 describing an inhalation element with an inhalation substance that is additionally applied to the inside of the face masks, whereby when the protective film is torn off, the inhalation substance is released into the space between the face mask and the respiratory system of the wearer. The inhalation element further includes a coloured indicator for monitoring the concentration of the inhalation substance, and the applicator can be replaced when the inhalation substance is exhausted. However, this inhalation element is not adapted for warm mist inhalation and does not include any means of heating of the inhalation substance. Another document CN 107467744 A describes a respirator with a filter element located on the outer side of the respirator. The fitter element comprises an inlet valve, an outlet valve and an openable lid under which a replaceable filter insert is inserted. Solid or liquid inhalation substance is applied to the filter insert, and the inhaled air enters the filter element through the inlet valve, is enriched with the inhalation substance and exits through the outlet valve oriented towards the user's respiratory system. However, even this document does not describe the possibility of heating the inhalation substance and, moreover, does not protect the inhalation substance from premature evaporation.

While both of the above solutions allow therapy by inhalation of the active substances from a respirator or face mask wherever the user is, they do not include a temperature control element to allow warm mist inhalation. Thus, there is currently no known solution for a universal and easy-to-use disposable inhaler device containing the selected inhalation substance that would prevent premature evaporation of the inhalation substance while providing the conditions necessary to perform warm mist inhalation anywhere and anytime without relying on electrical heating.

Detailed Description of the Invention

The above deficiencies are to some extent eliminated by the disposable inhalation substance applicator according to the present invention, which includes an inhalation substance source and an impregnation element in contact with the inhalation substance source, the impregnation element being breathable and adapted to absorb the inhalation substance. The inhalation substance source includes a first capsule and the inhalation substance disposed within the first capsule, wherein the disposable applicator further includes a heating element for heating the impregnation element in contact with the first capsule over a majority of a surface of the first capsule. The disposable inhalation substance applicator with a heating element makes it easy to induce conditions for warm mist inhalation, yet is universally applicable to a variety of inhalation and protective aids. Another advantage is the storage of the inhalation substance in the first capsule, which prevents unwanted release of the inhalation substance before the inhalation process begins.

The impregnation element is in contact with the first capsule on most of the surface of the first capsule. Most of the surface of the first capsule is meant to be more than 50% of its surface. The greater the surface area of the first capsule with which the impregnation element is in contact, the more uniform the absorption of the inhalation substance into the impregnation element. Preferably the impregnation element is in contact with at least more than 75 % of the surface of the first capsule, ideally the impregnation element is preferably completely surrounding the first capsule and is therefore in contact with 100 % of the surface of the first capsule in terms of absorbency. Ideally, the first capsule is surrounded by the impregnation element on at least two opposite sides of the first capsule. Preferably, the first capsule has a round or rounded shape.

In an advantageous design, the heating element of the disposable inhalation substance applicator includes an exothermically crystallising substance and an activator for initiating crystallisation that activates crystallisation of the exothermically crystallising substance and thus the heating function of the heating element. The use of exothermically crystallising substance for heating is not tied to any power source, it is fast, simple and applicable anywhere and anytime.

The heating element of the disposable inhalation substance applicator further preferably includes a second capsule, wherein the activator for initiating crystallisation is disposed within the second capsule. The advantage of placing the activator for initiating crystallisation inside the second capsule is the possibility of precise positioning of the activator for initiating crystallisation and avoiding premature activation of the heating function of the heating element.

The disposable inhalation substance applicator is preferably coupled to a mouthpiece, the mouthpiece being oriented towards the impregnation element. The combination of the disposable applicator with the mouthpiece forms a full-fledged portable inhaler, as the mouthpiece serves to direct the flow of cold air as it passes through the disposable applicator, where it is heated and enriched with the inhalation substance, and on to the user.

The disposable inhalation substance applicator is preferably implemented in a face mask, e.g. a face mask or a respirator. The face mask preferably comprises at least two breathable layers, wherein the disposable applicator is disposed between the layers of the face mask. The face mask thus acts as a protection against dust particles, viruses and bacteria, and at the same time allows the wearer to inhale an inhalation substance, e.g. a drug or fragrance. Once the inhalation substance is exhausted, the original protective function of the face mask is maintained.

Brief Description of the Drawings

The nature of the invention is further explained by examples of its designs, which are described using the accompanying drawings, where:

Fig. 1 illustrates a transverse and longitudinal section through a disposable inhalation substance applicator according to the first exemplary design.

Fig. 2 shows a transverse and longitudinal section through a disposable inhalation substance applicator (of a different external shape) according to the first exemplary design.

Fig. 3 shows a disposable inhalation substance applicator with a heating element in the shape of a hollow cylinder using a mouthpiece.

Fig. 4 illustrates a design of a disposable inhalation substance applicator implemented in a face mask.

Examples

The invention will be further explained by reference to examples of designs with reference to the relevant drawings. A first example design is a single-use applicator 1 of an inhalation substance having a heating element 6 in the form of a hollow ring, which is shown in Fig. 1. The heating element 6 includes an exothermically crystallising substance 7 inside, namely a supersaturated sodium acetate solution. In this design, the activator for initiating crystallisation 8 is contained in a second capsule 9 disposed within the heating element 9 and surrounded by the exothermically crystallising substance 7, wherein the sodium acetate and the activator for initiating crystallisation 8 are separated by a perforated wall of the second capsule 9. The activator for initiating crystallisation 8 in this design is soda or any other substance activating the crystallisation of sodium acetate. The second capsule 9 is positioned closer to the outer surface of the heating element 6, so that the wall of the second capsule 9 can be easily penetrated by fingers or the second capsule 9 can be cracked. The outer casing 12 of the heating element is made of a rigid yet flexible polymeric material, wherein the strength of the material is adapted to firmly enclose the sodium acetate within the heating element 6 so that the sodium acetate can expand volumetrically due to crystallisation processes. In a first exemplary design, the casing 12 of the heating element is made of polyethylene (PE), but may also be made of another polymer or elastomer (e.g., PP, PET, PA6, etc.).

The impregnation element 3 is adjacent to the inner side of the ring of the heating element 6 around its entire circumference. The impregnation element 3 is also ring-shaped and made of a breathable absorbent material (medical gauze, felt, etc.), the first capsule 5 containing the inhalation substance 4 being firmly seated inside this ring of the impregnation element 3. The contact area of the impregnation element 3 with the heating element 6 defines the so-called heat transfer surface area 13. The first capsule 5 comprising the inhalation substance 4 is spherical in shape and fills the interior space of the ring of the impregnation element 3, with which it is in direct contact around the entire circumference of the first capsule 5 at its widest point, but not over its entire surface. The poles of the first capsule 5 forming the upper and lower ends of the first capsule 5 are not in contact with the impregnation element 3 in the first exemplary design, in particular for reasons of compactness, ease of manufacture and to maximise the volume of the first capsule 5. However, the remainder of the surface of the first capsule 5 is in contact with the Impregnation element 3, and this remainder of the surface constitutes the majority of the surface of the first capsule 5, which is a sufficiently large surface on which the impregnation element 3 uniformly absorbs the inhalation substance 4 after the first capsule 5 has burst. For example, if the first capsule 5 were in contact with the impregnation element 3 on only one side thereof, the adjacent portion of the impregnation element 3 would be supersaturated with the inhalation substance 4 and the inhalation substance 4 might not be absorbed as uniformly into the entire volume of the impregnation element 3 as in the design where the impregnation element 3 surrounds the first capsule 5 around its entire circumference. The first capsule 5 is made of any suitable non-swelling material with sufficient handling strength (e.g., also polyethylene, glycerin gel, etc.) to guarantee the stability of the inhalation substance 4_and to prevent adverse reactions. The release and application of the inhalation substance 4 to the impregnation element 3 always occurs after the first capsule 5 has been ruptured, which initiates the start of the inhalation process.

The inhalation substance 4 within the protective first capsule 5 may be one or a plurality of substances from a set including fragrances, essences, substances used in the treatment of colds, rhinitis, asthma and other upper and lower respiratory tract diseases (over-the-counter or prescription-only), disinfectants, etc. The inhalation substances 4_specifically include e.g. hyaluronic acid, tantum verde (benzydamini hydrochloridum), octenidine 0.12%, damylmetacresol, sodium chloride, iodine, potassium, ambroxol, thioctic acid, nicotine, balsamic essential oils, essential oils, fragrances used in the food industry (menthol, mint, lemon balm, lavender, mexican mint, aloe vera), and others.

The warm mist inhalation using the disposable applicator 1. according to the invention is initiated by perforating the first capsule 5 with the inhalation substance 4 (only by manually squeezing the first capsule 5, or using the inserted perforation aid) and further activating the heating element 6 by perforating the wall of the second capsule 9 with the activator for initiating crystallisation 8. The rupture of the two capsules can be achieved, for example, by squeezing all or part of the disposable applicator 1 where the first capsule 5 and the second capsule 9 are located. The second capsule 9 releases the activator for initiating crystallisation 8, i.e., crystallisation germs, into the space of the heating element 6, which causes subsequent crystallisation of the supersaturated solution, an exothermic reaction in which heat is released. The sodium acetate is simultaneously expanded in volume, and the pressure on the impregnation element 3 and the adjacent first capsule 5 with the inhalation substance 4 promotes the release of the inhalation substance 4 into the environment. The inhalation substance 4 is absorbed onto the impregnation element 3 after rupture of the first capsule 5, whereby the contact surface of the heating element 6 and the impregnation element 3 (heat transfer surface area 13) heats the inhalation substance 4 to a temperature optimum for indifferent or warm mist inhalation and controlled evaporation (approximately 40 °C). In addition to contact heating, radiant heat from the heating element 6 contributes to heating the air and the inhalation substance 4. In inhalation using the disposable applicator 1 of the inhalation substance according to the invention, cold air from the vicinity of the applicator passes through the impregnation element 3, being heated and enriched with the vapours of the inhalation substance 4, and then the enriched and heated air continues to points of lower pressure, for example to the mouth of the user who is currently sucking air through the disposable applicator T The optimum evaporation time of the inhalation substance 4 is approximately 15 minutes, this time being determined individually for each inhalation substance 4 separately and depending on the amount of inhalation substance 4, the size of the first capsule 5, the thickness of the impregnation element 3, the heat output time of the heating element 6, etc. In this design of the activator for initiating crystallisation 8, the crystallisation of sodium acetate is irreversible, and the heating element 6 is therefore disposable.

In further designs, the disposable applicator 1 according to the invention may have different shapes, respectively the heating element 6 and the impregnation element 3 may have different shapes, for example Fig. 2 shows a square design of a disposable applicator 1 according to the invention. Important for the correct functionality of the invention is the relative arrangement of the components, that is, that the heating element 6 surrounds the impregnation element 3 over as much of its circumference as possible, and in particular that the impregnation element 3 surrounds the first capsule 5 over at least its entire circumference.

In another design of the disposable applicator 1 according to the invention, the heating element 6 comprises the activator for initiating crystallisation 8 in the form of a knurled convex metal plate disposed directly in the sodium acetate solution (not shown). The crystallisation of the sodium acetate solution and the exothermic reaction is activated manually by bending the metal plate from which the first microcrystals (crystallisation germs) are released into the sodium acetate solution. This design of the activator for initiating crystallisation 8 allows the reuse of the heating element 6, which can be brought back to its original state before crystallisation by an application of heat.

In an alternative design of the disposable applicator X the heating element 6 may comprise, instead of an exothermically crystallising substance 7, another active substance that is oxidised upon contact with air and subsequently heated. The heating element 6 in this design has an impermeable outer casing 12, wherein perforation of the outer casing 12 releases oxygen access to the active substance and initiates heating. Another design of the outer casing 12 of such a heating element 6 may include a microporous portion of the outer casing 12 covered with a protective film that is manually removed prior to activation of the heating element 6. In this design, the active substance is for example a mixture of iron powder, activated carbon, salt, water and optionally metal filings. This method of heating is suitable for longer warm inhalation times, which exceed the recommended application time for pharmaceuticals (15 min), but allows use, e.g. for inhalation of fragrances. The disposable applicator 1 may further comprise a fixed outer sleeve (not shown), so that the thermal and expansion effect of the heating element 6 is directed only to the interior of the disposable applicator 1.

The above designs of the disposable applicator 1. of the inhalation substance according to the invention are applicable for use with inhalation aids. A design of the disposable applicator 1 according to the invention in conjunction with the mouthpiece 10 is shown in Fig. 3. In this design, the disposable applicator 1 and the mouthpiece 10 have the shape of an elongated hollow cylinder for efficient suction and enrichment of air with the inhalation substance 4. The mouthpiece 10 is rigidly connected to the disposable applicator 1 in such a way that the mouthpiece 10 has one end adjacent to the ring of the heating element 6, the cavity of the mouthpiece 10 being directly connected to the impregnation element 3. Further, the mouthpiece 10 together with the disposable applicator 1 may be rigidly connected by the added outer sleeve mentioned above (this design includes the annular heating element 6 and is not shown in the figure). Mouthpiece 10 is disposable in this design. In a further design, the mouthpiece 10 is removably coupled to the disposable applicator 1 by sliding it onto the disposable applicator 1 or the outer sleeve, and once the inhalation substance 4 has been exhausted, the mouthpiece 10 can be fitted onto a new disposable applicator T For both the fixed and detachable connection of the mouthpiece 10 to the disposable applicator 1., the tightness of this connection during inhalation Is most important. The mouthpiece 10 may be of a simple cylindrical design or include arbitrary shaping.

A disposable applicator .1 of an inhalation substance according to the invention implemented in a face mask 11 is schematically shown in Fig. 4, where face mask 11 means a face mask, respirator, etc. The disposable applicator 1 has the same design as the disposable applicator 1 in the first design according to the invention (circular or square outer shape), or as in the second design (see below). The impregnation element itself 3 of the disposable applicator 1 implemented in the face mask 11 may include, in addition to the absorbent material, other layers, in particular with a filtering function (e.g. a nanofibrous membrane), which further support the protective function of the face mask 11. The face mask 11 comprises at least two breathable filter layers, preferably more. The face mask 11 may comprise, for example, 4 layers: a non-woven protective coating, a dust filter, a microbacterial filter and a nanofibrous filter, wherein the disposable applicator 1 is placed between the layers of the face mask 11 (when used for single inhalation). Alternatively, the disposable applicator 1 may be placed on the inside of the face mask 11 facing the respiratory system of the wearer (after the inhalation is complete, the disposable applicator 1 with the exhausted inhalation substance 4 may be replaced with a new one).

The placement of the disposable applicator 1 in the face mask 11 is advantageous for inhalation of both drugs in the treatment of disease and substances that can make the wearer feel more comfortable when wearing the protective face mask 11 for long periods of time. The insertion of the disposable applicator 1. into the protective face mask 11 does not interfere in any way with its original protective function, which continues to serve its purpose of protecting the wearer from fine dust particles, viruses and bacteria even after the inhalation substance 4 has been exhausted.

In a second exemplary design suitable for application to the face mask 11 , the disposable applicator 1 is pillow-shaped and includes a pocket-shaped impregnation element 3 made of an absorbent and permeable material, wherein the first capsule 5 with the Inhalation substance 4 is inserted and firmly sealed in the inner portion of the capsule, the contact surface of the first capsule 5 and the impregnation element 3 in this design occupying the entire surface of the first capsule 5. The heating element 6 in this design is a pad comprising sodium acetate and a metal plate as the activator for initiating crystallisation 8. The heating element 6 is attached to the impregnation element 3, which are then inserted and welded together in a rigid outer casing. The rigid outer casing includes two types of material, wherein the casing wall adjacent to the heating element 6 is made of impermeable material and the casing wall adjacent to the impregnation element 3 is made of breathable material. The breathable wall of the casing adjacent to the impregnation element 3 shall be oriented towards the respiratory system and shall be permeable to air and vapour of the inhalation substance 4. The advantages of this version of the disposable applicator 1 are its compact shape, small thickness and ease of manufacture and assembly. The disadvantage is the smaller contact area of the heating element 6 and the impregnation element 3, and therefore the rate of heat exchange between them.

An alternative design of the disposable applicator 1 may include a combination of any number of impregnation elements 3 and first capsules 5 with inhalation substance 4, to which the dimensions of the heating element 6 are adapted. For the purpose of cold mist inhalation, the disposable applicator 1 can be made completely without the heating element 6.

Industrial Application

Furthermore, the above-described disposable inhalation substance applicator can be used in any respiratory aid.

List of reference numbers

1 - disposable applicator

2 ~ inhalation substance source

3 - impregnation element

4 - inhalation substance

5 - first capsule 6 - heating element

7 - exothermically crystallising substance

8 - activator for initiating crystallisation

9 - second capsule

10 - mouthpiece

11 - face mask

12 - outer casing of the heating element

13 ~ heat transfer surface area