Patent Description:
In the treatment of certain diseases affecting the respiratory tract, it is known to administer a substance, such as a drug containing the active ingredient, in the form of an aerosol. For this type of administration, there are devices that make it possible to nebulise the drug after mixing it with a physiological solution. Such equipment includes a mouthpiece or mask for delivering the nebulised drug. It is also known to administer drugs via inhalers, in which the drug is not nebulised but aspirated directly by the user.

More recently, natural treatment methods have been developed involving the use of sodium chloride ("halotherapy"), which is "micronised", i.e. finely pulverised into particles having a size such as between <NUM> and <NUM> micrometres in size.

Halotherapy basically consists in inhaling an aerosol consisting of micronised sodium chloride. In a halotherapy session, the user is in a "salt chamber" where the atmosphere is saturated with sodium chloride, using salt micronising devices that dry-reduce pharmaceutical grade salt into micrometre-sized particles, which are then ionised. The micronising device is usually programmed to synchronise particle size, concentration, temperature (<NUM>°-<NUM>) and humidity (<NUM>-<NUM>%) by mixing the micronised salt with a regulated stream of air, which is then evenly dispersed throughout the salt chamber. The tiny negatively ionised salt particles create an aerosol, which is able to travel deep into the respiratory system and even reach the lungs at alveolar level.

The known devices have several drawbacks.

Delivering medical salt by aerosol does not allow to control the actual salt uptake by the user.

In addition, the treatments involve the use of a mixture of salts having different grain sizes. Therefore, it is difficult to determine the optimal dosage of the salts in the mixture, which varies depending on the user.

Recently, "helmets" for the assisted ventilation, e.g. in the continuous positive airway pressure (CPAP) ventilation, have often been used to treat breathing difficulties. However, it is difficult to use a product to be associated with such ventilation. Furthermore, it is not possible to control the dosage of such product.

<CIT>, <CIT>, <CIT> are known from the Patent Literature. However, they are suitable for therapies that are extremely different from halotherapy, as they require interventions on the product to make it inhalable, such as vaporisation, heating, etc. Thus, they represent a diversion towards devices which do not require any product treatment.

The object of the present invention is to overcome all or some of the drawbacks of the prior art.

A preferred object of the present invention is to enable a product used in a treatment to be better assimilated.

A further object of the present invention is to allow an optimal dosage of the product depending on the user.

According to the present invention, a delivery unit having the characteristics defined in claim <NUM> is provided.

The delivery unit allows the product to be picked up by the user aspiring the product, and to control the delivery depending on the aspiration force. The product is therefore completely assimilated by the user, without any dispersion.

According to an unclaimed aspect, an inhalation cartridge is provided.

The filter at the outlet opening is a selective filter to prevent crystals larger than a predetermined threshold from exiting and to allow air to exit, while the filtering material placed to close the perforation preferably only allows the passage of air but not of the crystals contained in the cartridge.

The cartridge contains the mixture suitable for a particular treatment, and does not need to be calibrated each time.

According to another unclaimed aspect , an inhalation kit is provided, comprising the delivery device and the cartridge containing the suitable mixture, which is connected to the delivery device to be optimally administered.

The delivery unit can be associated with an assisted ventilation system, particularly of the "CPAP" type, allowing treatment to be carried out even during ventilation by controlling the dosage of the product.

Further advantages and features of the present technology will be more apparent in the following detailed description, made with reference to the accompanying drawings, which represent a non-limiting example thereof, wherein:.

In <FIG>, a device for delivering at least a product to be inhaled is referred to as <NUM>. The device <NUM> is used in particular for inhaling micronised salt crystals.

The delivery device <NUM> comprises at least one chamber <NUM> having a first inlet opening <NUM> adapted to be connected to a cartridge <NUM> containing at least a product to be inhaled and a second outlet opening <NUM> adapted to be connected to an element for aspiring the product. The second opening <NUM> is arranged at a predetermined distance from the first opening <NUM>.

According to the technology, the delivery device <NUM> comprises at least one compensation valve <NUM> arranged at a third opening <NUM> made on a wall <NUM> of the chamber <NUM>, wherein the compensation valve <NUM> is adapted to maintain a closed configuration when the pressure inside the chamber <NUM> is substantially equal to the pressure outside the chamber <NUM> at the first inlet opening <NUM> and an open configuration when the pressure inside the chamber <NUM> is below a predetermined value.

The compensation valve <NUM> is shaped so as to have an opening proportional to the difference of pressure existing inside the chamber <NUM> and outside the chamber <NUM> at the inlet opening <NUM>.

The pressure inside the chamber is therefore maintained at a constant value during aspiration. This allows a constant dose of product to be delivered regardless of the inhalation force exerted by the user.

When the pressure inside chamber <NUM> is equal to the external pressure, i.e. when inhalation by the user does not occur, the valve <NUM> is closed. When inhalation occurs, the valve <NUM> opens and the opening increases proportionally with respect to the aspiration force, i.e. the difference of pressure generated inside the chamber <NUM>.

In a first embodiment, the delivery device <NUM> is used as a common inhaler, in which aspiration occurs via a mouthpiece.

In this embodiment, the compensation valve <NUM> connects the inside of chamber <NUM> directly with the outside environment. When inhalation occurs, the valve <NUM> opens and the opening increases proportionally to the negative pressure generated inside chamber <NUM>.

In other words, if the aspiration force is low, for instance because
exerted by a child, the valve tends to stay closed, so that the entire dose is inhaled. If, on the other hand, the aspiration force is high, the valve opens wide enough to generate a significant flow of air into the chamber, to prevent the delivery of an excessive dose of product.

<FIG> shows a first type of compensation valve of the duckbill check valve type. The valve <NUM> comprises a first lip <NUM> and a second lip <NUM> adjacent to each other in a closed configuration. The valve <NUM> is advantageously made of an elastic material, such as rubber.

In a closed configuration (<FIG>), the valve <NUM> has a substantially trapezoidal cross-section, with the larger base open arranged at the third opening <NUM> obtained on the wall <NUM> of the chamber <NUM>. The shorter base consists of the ends of the first lip <NUM> and the second lip <NUM> in an adjacent position, and is arranged inside the chamber <NUM>.

In the illustrated embodiment, when inhalation does not occur, the first lip <NUM> is in contact with the second lip <NUM>, and the valve <NUM> is closed.

When inhalation occurs, depending on the aspiration force by the user, the pressure inside the chamber <NUM> decreases, and the valve <NUM> opens allowing air to enter the chamber (<FIG>). The valve <NUM> is calibrated in such a way that the greater the inhalation, the greater the opening of the valve <NUM>, so that the negative pressure inside the chamber <NUM> during inhalation is kept at a constant predefined value and the same dose is always delivered.

The predefined value is determined on the basis of various parameters such as the size of the valve, the thickness of the first and second lip and the flexibility of the valve material.

<FIG> shows a second type of compensation valve, of the poppet valve type.

The poppet valve <NUM>' has a stem <NUM> having a substantially flat head <NUM> arranged at a first end <NUM> of the stem <NUM>.

The valve <NUM>' has a containment <NUM>, preferably circular, having a first open end <NUM> connected to the chamber <NUM> of the delivery device <NUM> at the third opening <NUM> and a second open end <NUM>. The head <NUM> of the valve <NUM>' is arranged at the opening of the first end <NUM> of the containment <NUM>. In the embodiment of <FIG>, the first end <NUM> of the containment <NUM> is advantageously associated with a connecting pipe <NUM> with the third opening <NUM> of the chamber <NUM>.

A guide support <NUM> of the stem <NUM> is arranged within the containment <NUM>. The return action is advantageously exerted by a spring <NUM>, such as a coil spring, interposed between the guide support <NUM> and the second end <NUM>' of the stem <NUM>.

In the embodiment shown, the valve is arranged outside the chamber. In an alternative embodiment, not shown, the valve is arranged inside the chamber.

In the embodiment of <FIG>, when inhalation does not occur, the head <NUM> of the valve <NUM>' is held by the spring <NUM> resting on the first end <NUM> of the containment <NUM>, closing the passage to the third opening <NUM> of the chamber <NUM> of the delivery device <NUM>.

When inhalation occurs, a force is exerted which brings the head <NUM> of the valve <NUM>' away from the first end <NUM> of the containment <NUM> opening the passage to the inside of the chamber <NUM>. The passage of air from outside the chamber <NUM> is proportional to the force exerted. Some parameters such as the opening size, the material of the head, the spring and the stem length are selected to maintain a constant negative pressure within the chamber.

In the embodiment shown, the containment <NUM> of the valve <NUM>' is substantially cylindrical. The opening of the first end <NUM> of the containment <NUM> and the head <NUM> of the valve are substantially circular.

In the embodiment shown in <FIG>, the guide support <NUM> is disc-shaped, preferably having an outer ring <NUM> and an inner ring <NUM> and connecting arms <NUM>, for example four, between the outer ring <NUM> and the inner ring <NUM>.

In a preferred embodiment, the compensation valve is adjustable.

<FIG> shows a variant <NUM>" of the valve of <FIG>, wherein the containment <NUM>'' has an inner threaded wall <NUM> and the guide support <NUM>" has a counter threaded outer wall <NUM>, so that the guide support <NUM>" can be screwed inside the containment <NUM>''.

When the guide support <NUM>'' is fully screwed in, the force of the spring <NUM> is minimal, whereas by unscrewing the guide support <NUM>'' the spring <NUM> is compressed, thus increasing the force required to open the valve. Thereby, the preload on the spring can be varied depending on the conditions of use.

The guide support <NUM>'' is preferably provided with a scale to indicate the set opening pressure in order to facilitate adjusting the valve based on the user.

<FIG> shows the guide support <NUM>'' of the valve of <FIG>. The guide support <NUM>" is substantially cylindrical and has an outer threaded wall <NUM>. The support <NUM>" has at one first end <NUM> a central ring <NUM>'' inside which the stem <NUM> of the valve <NUM>" can slide. The central ring <NUM>'' is connected by means of four arms <NUM>'' to the side wall <NUM>. The second end <NUM> of the guide support <NUM>" is open and surrounded by a flange <NUM>.

Advantageously, the poppet valve <NUM>', <NUM>'' has a sealing ring <NUM>, such as an O-ring, arranged between the outer side wall <NUM> of the guide support <NUM>, <NUM>" and the inner wall <NUM> of the containment <NUM>, <NUM>'' of the valve <NUM>', <NUM>'' (<FIG>).

In an advantageous embodiment, the guide support <NUM>, <NUM>'' has an extension <NUM> extending beyond the containment <NUM>, <NUM>'' of the valve <NUM>', <NUM>'' (<FIG>).

<FIG> shows a variant of the valve of <FIG>, wherein the valve <NUM>'' has a sealing ring <NUM>, such as an O-ring, arranged between the outer side wall <NUM> of the guide support <NUM> and the inner wall <NUM> of the valve containment <NUM>. In such an embodiment, the guide support <NUM> has an extension <NUM> extending beyond the valve containment <NUM>.

In particular, as illustrated in <FIG>, the outer wall <NUM> of the guide support <NUM> has a first threaded portion <NUM> and a thread-free portion <NUM> on which the sealing ring <NUM> is arranged. The thread-free portion <NUM>, which extends outside the containment <NUM>, allows the valve to be connected to an external pipe.

The embodiments shown in <FIG> are advantageous when using the delivery device in a continuous positive airway pressure "CPAP" assisted ventilation system, as will be described below.

According to an aspect of the present disclosure, a cartridge <NUM> connectable to a delivery device <NUM> is provided.

The cartridge <NUM> contains at least a product to be inhaled, namely micronised salt crystals. In a preferred implementation the cartridge contains <NUM>-<NUM> grams of micronised salt. The size of the salt particles varies depending on the treatment to be carried out. They may be basically of four types.

The first type of 'A' particles is <NUM> to <NUM> in size and has the main function of transporting the salt particles, preventing them from aggregating.

A second type of 'B' particles is up to <NUM> microns in size.

A third type of 'C' particles is <NUM> to <NUM> microns in size.

A fourth type of 'D' particles is <NUM> to <NUM> microns in size.

For exemplary purposes, the cartridge <NUM> may contain a mixture consisting of <NUM>% of "A" particles, <NUM>% of "B" particles, <NUM>% of "C" particles and <NUM>% of "D" particles. The composition varies depending on the treatment required.

The cartridge <NUM> can be replaced and connected to the delivery device <NUM> as required.

The cartridge <NUM> comprises a containment element <NUM> with a product outlet opening <NUM>. The cartridge <NUM> is advantageously made of plastic. The walls <NUM> of the cartridge <NUM> are at least partially perforated and preferably lined with a filtering material.

In the embodiment shown in <FIG>, the cartridge <NUM> has a substantially parallelepiped shape. The cartridge <NUM> is perforated on one or more sides to allow air to pass through. The perforated sides are advantageously lined with a filtering material to prevent salt particles from exiting.

A filter is arranged at the outlet opening <NUM>,
preferably a <NUM>-<NUM> micron filter, in order to prevent larger salt particles from reaching the user's mouth.

In an embodiment not shown, the containment <NUM> has a door for inserting an envelope already provided with a filtering net.

According to an aspect of the present disclosure, an inhalation kit is provided comprising a delivery device <NUM> and a cartridge <NUM> to be connected to the delivery device.

According to the present invention, a delivery unit <NUM> of at least one product to be inhaled is provided.

<FIG> shows an embodiment wherein the delivery unit <NUM> is arranged in an assisted ventilation system <NUM>, such as of the continuous positive airway pressure (CPAP) type. Such system <NUM> involves the use of a helmet <NUM>, which allows to provide artificial ventilation to a patient with breathing difficulties. The helmet <NUM> is normally connected to at least two pipes:
a pipe <NUM> for air/oxygen supply and a discharge pipe <NUM>.

The system <NUM> comprises a gas mixer <NUM> with an oxygen inlet duct <NUM> and an air inlet duct <NUM>. The gas leaving the mixer <NUM> is at a pressure of about <NUM> mbar and is led to a humidifier/heater <NUM>. The outlet pipe <NUM> from the humidifier/heater is connected to a compensation tank <NUM> to maintain a constant pressure.

The pipe <NUM> is connected to the delivery unit <NUM>.

According to the invention, the delivery unit <NUM> comprises a delivery device <NUM>, wherein the second outlet opening <NUM> is adapted to be connected to a first pipe <NUM>; at least one cartridge <NUM> comprising a containment element <NUM> for at least a product to be inhaled, in particular comprising micronised salt crystal particles of different sizes, having an inlet <NUM> adapted to be connected to a second pipe <NUM> and an outlet <NUM> associated with the inlet opening <NUM> of the delivery device <NUM>; and a first compensation duct <NUM> having a first end <NUM> adapted to connect the second pipe <NUM> upstream of the cartridge <NUM> and a second end <NUM> connected to the compensation valve <NUM> of the delivery device <NUM>.

In the embodiment shown in <FIG>, the delivery unit <NUM> advantageously comprises a by-pass valve <NUM> having an inlet <NUM>, a first outlet <NUM> and a second outlet <NUM>, wherein the inlet <NUM> is adapted to be connected to the second pipe <NUM>; a second supply duct <NUM> having a first end <NUM> connected to the first outlet <NUM> of the by-pass valve <NUM> and a second end <NUM> connected to the inlet <NUM> of the cartridge <NUM>; and a third by-pass duct <NUM> having a first end <NUM> connected to the second outlet <NUM> of the by-pass valve <NUM> and a second end <NUM> adapted to be connected to the first pipe <NUM>.

In particular, the by-pass valve <NUM> has an inlet <NUM> adapted to be connected to the pipe coming from the humidifier/heater <NUM>. When the by-pass valve <NUM> is closed, the air/oxygen mixture is sent directly to the pipe <NUM> connected to the helmet. When the by-pass valve <NUM> is open, the pressurised air/oxygen mixture passes through the cartridge <NUM> picking up the product and enters the chamber <NUM> of the delivery device <NUM>.

Upon each inhalation by the user, the pressure inside the chamber <NUM> of the delivery device <NUM> decreases and the pressure change causes the compensation valve <NUM> to open. The valve <NUM> is sized to maintain a constant difference of pressure within chamber <NUM> during inhalation, so that the correct dose of product can be inhaled.

It is possible to administer the product to the user only when require by adjusting the opening and closing of the by-pass valve <NUM>.

<FIG> shows an embodiment of the cartridge <NUM>', which can be used in particular in the delivery unit.

The cartridge <NUM>' has a first substantially rectangular-shaped adapter <NUM> placed at the inlet <NUM>, to be connected to the supply duct <NUM>. The cartridge <NUM>' further has a second substantially circular-shaped output adapter <NUM>, to be connected to the first inlet opening <NUM> of the delivery device <NUM>.

Advantageously, in the delivery unit <NUM> the delivery device <NUM> described with reference to <FIG> may be used, wherein the extension <NUM> of the guide support <NUM> enables the connection with the compensation duct <NUM>.

In understanding the object of the present invention, the term "comprising" and its derivatives, as used herein, are intended as open-ended terms that specify the presence of declared characteristics, elements, components, groups, integers and/or steps, but do not exclude the presence of other undeclared characteristics, elements, components, groups, integers and/or steps. The above also applies to words, which have similar meanings, such as the terms "comprised", "have" and their derivatives. Furthermore, the terms "part", "section", "portion", "member" or "element" when used in the singular can have the double meaning of a single part or a plurality of parts. As used herein to describe the above executive embodiment(s), the following directional terms "forward", "backward", "above", "under", "vertical", "horizontal", "below" and "transverse", as well as any other similar directional term, refers to the embodiment described in the operating position. Finally, terms of degree, such as "substantially", "about" and "approximately", as used herein, are intended as a reasonable amount of deviation of the modified term such that the final result is not significantly changed.

Claim 1:
A unit for delivering at least one product to be inhaled comprising a delivery device,
wherein said delivery device comprises at least one chamber (<NUM>) having a first inlet opening (<NUM>) adapted to be connected to a cartridge (<NUM>) containing at least a product to be inhaled, a second outlet opening (<NUM>) adapted to be connected to at least one product aspirating element, the second outlet opening (<NUM>) being arranged at a predetermined distance from the first inlet opening (<NUM>), wherein the device further comprises at least one compensation valve (<NUM>) arranged at a third opening (<NUM>) made on a wall (<NUM>) of the chamber (<NUM>), wherein the compensation valve (<NUM>) is adapted to maintain a closed configuration when the pressure inside the chamber (<NUM>) is substantially equal to the pressure in a first compensation duct (<NUM>) and an open configuration when the pressure inside the chamber (<NUM>) is lower than a predetermined value,
wherein the second outlet opening (<NUM>) is adapted to be connected to a first pipe (<NUM>); at least one cartridge (<NUM>) comprising a containment element (<NUM>) for a product to be inhaled, in particular micronized salt crystal particles of different sizes, having an inlet (<NUM>) adapted to be connected to a second pipe (<NUM>) and an outlet (<NUM>) adapted to be associated with the inlet opening (<NUM>) of the delivery device (<NUM>); and the first compensation duct (<NUM>) having a first end (<NUM>) adapted to be connected to the second pipe (<NUM>) upstream of the cartridge (<NUM>) and a second end (<NUM>) connected to the valve (<NUM>) of the delivery device (<NUM>).