DESCRIPTION

[0001]The present invention is a nebulizer device for the administration of a substance, preferably a drug or a therapeutic agent or another appropriate substance.

[0002]In particular, the nebulizer device falls within the field of application of devices for the administration of drugs, therapeutic agents, or any other appropriate substance via inhalation. [0003]Specifically, the present invention is an

"ultrasonic pump" nebulizer device for the production of a specific aerosol mist for inhalation, i.e. specific for crossing the respiratory tract. In particular, the nebulizer device of the present invention is suitable to fall within the field of the art comprising MDI ("Metered Dose Inhaler") devices and aerosol devices.

[0004]A multitude of embodiments of devices for the administration of substances via inhalation are known from the prior art. In particular, the nebulizer device of the present invention belongs to the field of the art which includes devices for the administration of substances via inhalation which are suitable to allow the administration of a substance in nebulized form starting from the substance supplied in liquid form. In particular, the nebulizer device of the present invention falls within the field of the art which includes ultrasonic pump nebulizers comprising a plate-like element comprising a plurality of micro through-holes (also known as mesh), in metallic material or in another material, the vibratory movement of which involves the nebulization of the liquid substance. An example of such known embodiments is shown in JP-U-3-15674.

[0005]In other words, in the known forms of application, the substance is supplied in liquid form and is nebulized and dispensed through the respiratory tract of the user by means of such devices.

[0006]In the known embodiments, said substances are supplied, and therefore available on the market, in liquid form, preferably placed in special openable containers and pourable into certain reservoir portions of the devices in which they are subject to nebulization operations .

[0007]Moreover, in many known preferred embodiments, said substances are already inserted in the dispensing device of the manufacturer or the pharmaceutical company.

[0008]It is a problem of the known solutions from the prior art to provide and allow the user to use a certain and measured dose of the substance in a simple and practical manner. [0009]The substance is often dispensed incorrectly in the known solutions: with an excessive speed, with particles of variable diameter and/or in an undefined amount, causing poor absorption, waste, and environmental pollution. [0010]Furthermore, in the known solutions, an amount of the substance often remains in the openable containers in which it is supplied or remains in the portions of the reservoir into which it is poured.

[0011]It is intuitive that the aforementioned situations are undesirable both for economic reasons and especially for the user's health.

[0012]The need is therefore strongly felt to solve the aforementioned problems by obviating the occurrence of the aforementioned issues. [0013]It is the object of the present invention to provide a nebulizer device for the administration of a substance which fulfills the aforesaid requirement. In other words, it is the object of the present invention to provide a nebulizer device which minimizes, up to eliminating, the occurrence of such events, ensuring a nebulization/atomization of the substance having constant features and a definite amount.

[0014]Such an object is achieved by a nebulizer device for the administration of a substance as claimed in claim 1. [0015]The claims dependent thereon show preferred embodiments involving further advantageous aspects.

[0016]Further features and advantages of the invention will become apparent from the description provided below of preferred exemplary embodiments thereof, given by way of non-limiting example, with reference to the accompanying drawings, in which:

[0017]- figure 1 is a perspective view of the nebulizer device in accordance with an embodiment, according to the present invention; [0018]- figure 2 is a perspective view with separate parts of the nebulizer device in figure 1;

[0019]- figure 3 is a sectional view with separate parts of the nebulizer device in figures 1 and 2;

[0020]- figure 4 is a perspective view with separate parts of a capsule of a nebulizer device according to the present invention, in accordance with an alternative embodiment;

[0021]- figure 5 is a sectional view of the capsule in figure 4; [0022]- figures 6a and 6b are two sectional views of two capsules according to certain alternative embodiments; [0023]- figures 7a and 7b are two perspective views of the nebulizer device in accordance with a further embodiment, according to the present invention; [0024]- figures 8a and 8b are two perspective views of the nebulizer device in accordance with a still further embodiment, according to the present invention;

[0025]- figure 9 is a perspective view of the capsule of a nebulizer device according to the present invention, in accordance with an alternative embodiment;

[0026]- figure 10 is a sectional view of the capsule in figure 8.

[0027]With particular reference to the accompanying figures, reference numeral 1 shows a nebulizer device in its entirety.

[0028]The nebulizer device 1 allows the administration of a substance S. Preferably, said substance S is a drug or a therapeutic agent.

[0029]In accordance with the present invention, as widely described below, the substance S is dispensed by the nebulizer device 1 in nebulized form starting from the liquid state thereof.

[0030]The nebulizer device 1 of the present invention comprises a main body 2 extending along an axis X-X between a head region 20 and a base region 21.

[0031]Preferably, the main body 2 has dimensions that make it grippable by a user.

[0032]Preferably, the main body 2 has dimensions that make it restable on a surface, e.g. on a table. [0033]Furthermore, according to the present invention, the main body 2 comprises gripping means 25 positioned at said head region 20. Said gripping means 25 will be fully described successively.

[0034]In accordance with a preferred embodiment, the nebulizer device 1 comprises a command group 3 housed in the main body 2 suitable to command the atomization of the substance S.

[0035]According to a preferred embodiment, the command group 3 is suitable to produce a vibratory action in a direction parallel to the axis X-X.

[0036]In accordance with a preferred embodiment, the command group 3 comprises a vibratory element of the piezo-electric type 31, comprising a command head 315 suitable to protrude from the main body 2. [0037]Preferably, said command head 315 vibrates at a frequency of about 200kHz.

[0038]Preferably, said command head 315 travels a stroke along the axis X-X of a measurement between 15 and 60 microns. [0039]Preferably, said command head 315 protrudes into a receiving area 200 comprised in the head region 20.

[0040]In accordance with the present invention, the nebulizer device 1 comprises a capsule 5 containing the substance S. [0041]In particular, the substance is contained in the capsule 5 in a liquid state. When subjected to a vibratory action, the capsule 5 is further suitable to dispense said substance in atomized form.

[0042]In fact, the capsule 5 is engageable with the main body 2 so as to engage the command group 3.

[0043]In accordance with the present invention, the capsule 5 extends with respect to the axis X-X. Preferably, the capsule 5 has a substantially cylindrical shape. [0044]According to a preferred embodiment, in an engaged configuration with the main body 2, the capsule 5 is engaged by the command head 315 of the piezo-electric vibratory element 31.

[0045]In fact, preferably a portion of the capsule 5 is suitable to find housing in the receiving area 200 so as to directly contact the command head 315.

[0046]In fact, the capsule 5 is removably engageable with the main body 2, and in particular engageable with the gripping means 25. [0047]In accordance with a preferred embodiment, said gripping means 25 comprise an annular engagement collar 250, removably engageable from the specially-shaped capsule 5. Preferably, said annular engagement collar 250 extends in height parallel to the axis X-X. Preferably said annular engagement collar 250 defines the receiving area 200.

[0048]According to a preferred embodiment, the capsule 5 is removably engageable with the gripping means 25.

[0049]In fact, preferably, in accordance with a preferred embodiment, the engagement collar 250 comprises a thread 255. Preferably, the capsule 5 comprises an engagement surface 55 screwable to said thread 255.

[0050]Preferably, the thread 255 faces radially outwards. Preferably, the engagement surface 55 faces radially inwards.

[0051]Preferably, the capsule 5 is removably engageable by the gripping means 25.

[0052]In fact, according to a preferred embodiment, the engagement collar 250 comprises elastically yielding teeth 251; said elastically yielding teeth 251 are radially movable between a holding configuration and a release configuration.

[0053]Preferably, the capsule 5 comprises an engagement groove 58 in which said elastically yielding teeth 251 are suitable to find housing in the holding configuration .

[0054]In accordance with a preferred embodiment, the elastically yielding teeth 251 are normally in the holding configuration, so that the capsule 5, in order to be fixed to the main body 2, must overcome the elastic action of the elastically yielding teeth 251.

[0055]In accordance with the present invention, the capsule 5 comprises a lower half-container 6 and an upper half-container 7 in sealed mutual engagement, delimiting a reservoir chamber 50 in which the substance S is contained. In other words, in accordance with the present invention, the mutual coupling between the lower half container 6 and the upper half-container 7 delimits a reservoir chamber 50 in which the substance S is housed in a liquid state.

[0056]In accordance with the present invention, the lower half-container 6 comprises a lower plate 61 with an extension substantially orthogonal to the axis X-X engageable by the command group 3. [0057]In other words, in accordance with the present invention, in a configuration with the capsule 5 mounted to the main body 2, the lower half-container 6 is directly engaged with the command head 315 to receive the vibratory action. [0058]In particular, in accordance with a preferred embodiment, the lower plate 61 comprises an engagement portion 610 suitable to be engaged by the command group 3 and to receive the command action thereof.

[0059]According to a preferred embodiment, the engagement portion 610 is made of a material belonging to the family of metals and metal alloys. For example, in a preferred embodiment, the engagement portion 610 is made of titanium. For example, in a preferred embodiment, the engagement portion 610 is made of platinum. For example, in a preferred embodiment, the engagement portion 610 is made of stainless steel.

[0060]According to a further preferred embodiment, the engagement portion 610 is made of a polymeric material or a ceramic material. For example, in a preferred embodiment, the engagement portion 610 is polyether- ether-ketone (PEEK).

[0061]In accordance with a preferred embodiment, the gripping means 25 engage said lower half-container 6.

[0062]According to a preferred embodiment, the lower half- container 6 is firmly and rigidly engageable with the main body 2.

[0063]In accordance with the present invention, the upper half-container 7 comprises an upper plate 71 with an extension substantially parallel to the lower plate 61. [0064]Preferably, said upper plate 71 comprises a reticular outflow portion 710 comprising a plurality of holes 710'.

[0065]In accordance with a preferred embodiment, said holes 710' are accurately sized as a function of the desired average diameter of the substance particles in the dispensing step.

[0066]According to a preferred embodiment, said holes 710' have a conical section parallel to the axis X-X so as to facilitate the atomization of the substance particles along the axis X-X. In accordance with a preferred embodiment, the conical section has a circular or elliptical base. In accordance with a further preferred embodiment, the conical section has a polygonal base, for example it has a hexagonal or triangular base. [0067]In accordance with this preferred embodiment, said holes 710' have different diameters between the upper part and the lower part of the lower plate. In particular, said holes 710' have a smaller diameter section in the upper part and a larger diameter section in the lower part, i.e. that in contact with the substance to be nebulized.

[0068]According to a preferred embodiment, the reticular outflow portion 710 is made of a material belonging to the family of metals and metal alloys. For example, in a preferred embodiment, the reticular outflow portion 710 is made of titanium. For example, in a preferred embodiment, the reticular outflow portion 710 is made of platinum. For example, in a preferred embodiment, the reticular outflow portion 710 is made of stainless steel. [0069]According to a further preferred embodiment, the reticular outflow portion 710 is made of a polymeric material or a ceramic material. For example, in a preferred embodiment, the reticular outflow portion 710 is polyether-ether-ketone (PEEK). [0070]In accordance with the present invention, the lower plate 61 and the upper plate 71 are mutually movable relative to each other in the direction of the axis X-X. Preferably, this movement corresponds to the atomization of the substance S through the reticular outflow portion 710.

[0071]According to the present form of the invention, the movement of the upper plate 71 involves the nebulization of the liquid substance, which outflows through the area 710. [0072]In other words, the movement of the upper plate 71 results in a pump effect on the substance S, which, crossing the holes 710' of the reticular outflow portion 710, is dispensed towards the outside of the capsule 5. [0073]In accordance with a preferred embodiment, the vibratory action produced by the command group 3 on the lower plate 61 is transmitted to the upper plate 71 by the substance S present in the reservoir chamber 50. That is to say, the vibrations emitted by the command group 3 on the lower plate 61 create a series of longitudinal waves in the substance S, parallel to the axis X-X that are discharged on the upper plate 71.

[0074]According to a preferred embodiment, the upper half container 7 comprises an annular element 72 engaged with the upper plate 71. Said annular element 72 has an elastically yielding behavior so as to allow the vibrational movement of the upper plate 71 with respect to said axis X-X.

[0075]In accordance with a preferred embodiment, said annular element 72 is an O-ring integrally connected with the upper plate 71.

[0076]According to a preferred embodiment, the upper plate 71 is suitable, due to the annular element 72, to perform a translational movement parallel to the axis X-X.

[0077]In accordance with a preferred embodiment, the reservoir chamber 50 comprises an atomization region 51 comprised between the lower plate 61 and the upper plate 71 where the substance S is arranged before being dispensed.

[0078]In accordance with a preferred embodiment, the lower plate 61 and the upper plate 71 are spaced along the axis X-X by a distance depending on the nature of the substance to be nebulized and on the desired features of the atomized particles.

[0079]According to a preferred embodiment, the lower plate 61 and the upper plate 71 are spaced along the axis X-X by a distance between 2 and 12 tenths of a millimeter.

Preferably, said distance varies according to the features of the substance and therefore according to the capillarity of said substance. [0080]Therefore, preferably a liquid film of the substance

S is arranged between the lower plate 61 and the upper plate 71.

[0081]In accordance with a preferred embodiment, the substance S is positioned between the lower plate 61 and the upper plate 71 by capillarity.

[0082]According to a preferred embodiment, the reservoir chamber 50 comprises an atomization region 51, corresponding to the space present between the lower plate 61 and the upper plate 71. [0083]In particular, the substance S arranged in said atomization region 51 transmits the longitudinal waves which the lower plate 61 is subject to, to discharge them to the upper plate 71. Free to vibrate axially, the upper plate 71 is therefore suitable to perform a pumping action on the substance itself, which is then dispensed out of the capsule 5. In other words, the combined vibrations of the lower plate 61 and of the upper plate 71 create a pump effect, which generates the aerosolization of the substance S generated in crossing the holes of the upper plate 71. [0084]In accordance with a preferred embodiment the reservoir chamber 50 comprises a reservoir region 52 distal from the axis X-X and surrounding the atomization region 51. [0085]In accordance with a preferred embodiment, the reservoir region 52 has, when moving away from the axis

X-X, a larger section than the section of the atomization region 51.

[0086]In accordance with a preferred embodiment, the reservoir region 52 extends in height parallel to the axis X-X. In particular, the reservoir region 52 extends in height substantially starting from the lower plate 61. [0087]Therefore, preferably the substance S, subject to the force of gravity, flows towards the atomization region 51.

[0088]In accordance with a preferred embodiment, the reservoir region 52 is inclined towards the axis X-X. In other words, the reservoir region 52 has such an extension as to be incident towards the X-X axis at the lower plate 61 or at an imaginary area below the lower plate 61.

[0089]In accordance with a preferred embodiment, the lower half-container 6 comprises a lower body 63 supporting the above-described components, suitable to engage the upper half-container 7 and the main body 2. [0090]Preferably, the lower body 63 is a single element made of plastic material.

[0091]In a preferred embodiment, the lower body 63 comprises the engagement portion 610. [0092]According to a preferred embodiment, the lower body

63 is obtained by molding.

[0093]Preferably, the engagement portion 610 is obtained in one piece with the lower body 63.

[0094]Preferably, the engagement portion 610 is obtained by co-molding operations with the lower body 63.

[0095]In accordance with a preferred embodiment, the lower body 63 is shaped to house the annular engagement collar 250.

[0096]In accordance with a preferred embodiment, the upper half-container 7 comprises an upper body 73 supporting the above-described components comprised therein. In particular, the upper body 73 is suitable to support and/or comprise the upper plate 71 and/or the annular element 72. [0097]Preferably, the upper body 73 is suitable to engage the lower body 63.

[0098]Preferably, the upper body 73 is shaped to house the lower body 63 and the reservoir chamber 50.

[0099]Preferably, the upper body 73 is a single element made of plastic material. [00100] In a preferred embodiment, the upper body 73 comprises the upper plate 71.

[00101] In a preferred embodiment, the upper body 73 comprises the elastic element 72. [00102] In accordance with other embodiments, the upper plate 71 and/or the elastic element 72 are mounted to the upper body 73.

[00103] According to a preferred embodiment, the upper body 73 is obtained by molding. [00104] In accordance with a preferred embodiment, the upper half-container 7, preferably the upper body 73, comprises a diffuser 730, positioned in a region axially consecutive to the upper plate 71, suitable to facilitate the atomization of the substance S in the axial direction.

[00105] Preferably, the upper plate 71 is axially positioned on the bottom of the diffuser 730.

[00106] In accordance with a preferred embodiment, the command group 3 further comprises a command motherboard 32 operatively connected to the piezo-electric vibratory element 31 to switch it on and command it in vibration. [00107] Furthermore, according to a preferred embodiment, the command group 3 comprises a power supply member 33 suitable to electrically power the piezo- electric vibratory element 31 and the command motherboard 32. Preferably, the power supply member 33 is a rechargeable battery.

[00108] In accordance with a preferred embodiment, the command group 3 also comprises switch-on elements suitable to command the automatic switching on of the command group 3, with consequent atomization of the substance, according to the user's presence.

[00109] Preferably, the command group 3, and in particular the command motherboard 32 thereof, is configurable in accordance with the type of capsule 5 to be dispensed. That is to say, depending on the capsule 5 and in particular on the amount of substance S comprised therein, the command motherboard 32 is suitable to regulate a vibratory action of varying length in time. [00110] For example, said switch-on elements detect the user's presence by detecting the inhalation action thereof.

[00111] For example, said switch-on elements detect the user's presence by detecting the pressure action thereof on the nebulizer device 1.

[00112] According to a preferred embodiment, the nebulizer device 1 comprises a conveyor element 90, of the nasal type 91 and/or of the oral type 92 suitable to convey the substance S towards the user's airways. [00113] Preferably, the conveyor element 90 comprises openings 900 suitable to allow the entry of air from the external environment. Preferably, said air mixes with the atomized substance S into the conveyor element 90 to then reach the user's airways. [00114] According to a preferred embodiment, the conveyor element 90 is removably mountable to the main body 2. According to a preferred alternative embodiment, the conveyor element 90 is removably mountable to the capsule 5 mounted to the main body 2. Preferably, the mounted conveyor element 90 is suitable to contain the capsule 5.

[00115] In accordance with what has been described above, and with what is shown by way of example in the accompanying figures, the capsule 5 has an axial symmetrical structure with respect to an axis of extension, which in the mounted capsule configuration corresponds to the axis X-X.

[00116] In accordance with a preferred embodiment, a plurality of atomization capsules 5, for example corresponding to a therapeutic cycle of cures, is suppliable in a container group. In said container group, each capsule 5 is housed in a sealed and safe manner, in a preferred housing.

[00117] Preferably, said container group is suitable to have the dimensions of a pillbox already known on the market.

[00118] Innovatively , the nebulizer device fully solves the purpose for which it is provided.

[00119] Advantageously, the nebulizer device is suitable to solve the problems of the prior art, allowing a simple and foolproof use of the substance.

[00120] Advantageously, the nebulizer device is suitable to perform an atomization (and spraying) action of the substance so as to present an effective distribution of the substance in the inhalation flow.

[00121] Advantageously, the substance is nebulized homogeneously. Advantageously, the atomized substance particles all have the same features.

[00122] Advantageously, the nebulizer device obviates the problem of wasting the substance to be administered. Advantageously, the substance is entirely consumed with certainty. Advantageously, once the capsule is finished, the problem of the substance remaining inside the same is obviated. [00123] Advantageously, as the substance is consumed, it is disposed in the atomization region of the reservoir chamber by capillarity. Advantageously, as the substance is consumed, it is disposed in the atomization region of the reservoir chamber, because it is subject to the force of gravity. Advantageously, as the substance is consumed it is disposed in the atomization region of the reservoir chamber, subject to a suction action.

[00124] Advantageously, the capsule is mountable and dismountable. [00125] Advantageously, the capsule is provided as a disposable instrument.

[00126] Advantageously, the capsule does not run the risk of obstruction phenomena, for example of the holes. [00127] Advantageously, the use of the nebulizer device is foolproof.

[00128] Advantageously, the substance is hygienically sealed in the capsule, thus making it impossible to contaminate it from the outside.

[00129] Advantageously, a cycle of therapies can include the consumption and use of a predefined number of capsules. Advantageously, the capsules are easy to transport (similarly to the transport of a tablet or a blister of tablets for oral use).

[00130] Advantageously, the nebulizer device is suitable to be used for different therapies, by replacing the capsules.

[00131] Advantageously, the nebulizer device performs the atomization operations of the substance only when the user is inhaling, while it blocks the atomization operations when the user is exhaling, avoiding any waste of substance, and therefore of drug.

[00132] It is apparent that, in order to meet contingent needs, those skilled in the art may make changes to the subject of the present invention described above, all contained within the scope of protection defined by the following claims.