INHALATION SYSTEM WITH A MESH NEOFLOWER AND A FACE MASK

Description

FIELD OF INVENTION

[0001] The present invention relates to an inhalation system and its use for administering an active ingredient into the respiratory tract of a user.

[0002] More specifically, the present invention relates to a system for inhaling an aerosol produced by a sieve nebulizer. STATE OF THE ART

[0003] Aerosol therapy involves administering an aerosol into a user's respiratory tract (or airways). This technique can be used for various purposes, such as administering active ingredients that act locally on the airways, humidifying the airways to thin bronchial secretions, or administering a pathogen or marker for clinical or research trials. The aerosol is produced by a nebulizer, which transforms the liquid into fine droplets (aerosol) that are then injected into a mask (nasal, facial, oral, or nasal) for inhalation by the user.

[0004] However, known inhalation systems are not satisfactory.

[0005] Indeed, the deposition of aerosols in the user's lungs is inefficient with existing systems because, during the exhalation phase, a significant proportion of droplets are lost to the surrounding air. Furthermore, the mask's volume includes a dead volume that limits aerosol penetration into the user's airways, resulting in aerosol deposition primarily in the upper respiratory tract and, to a lesser extent, in the lungs. This effect is particularly noticeable in young children, whose inhaled volume is much lower than that of adults and, in some cases, even lower than the mask's volume.

[0006] This low efficiency of aerosol deposition in the lungs can also be caused by the type of nebulizer used. Indeed, most known nebulizers have a low efficiency, resulting in a high proportion (up to 50%) of residual liquid remaining in the nebulizer at the end of the session.

[0007] Some systems are equipped with a mesh nebulizer connected to a T-piece with two openings. One opening is connected to a mask, while the other is open to ambient air. During exhalation, the patient's exhaled air exits through the open opening, carrying the aerosol produced by the nebulizer into the outside air and thus generating aerosol loss. During inhalation, outside air enters through the open opening, carrying the aerosol produced by the nebulizer to the mask and ultimately to the patient. Since the inside of the mask is aerosol-free at the beginning of inhalation, a portion of the inhaled air does not contain aerosol. This reduces the amount of aerosol entering the respiratory tract.The amount of aerosol entering the airways is reduced in masks with a nebulizer that opens directly into the center of the mask and injects the aerosol perpendicularly to the user's face. However, during pauses in breathing or at low inspiratory flow rates, when the user is sitting or lying down, the aerosol is projected directly onto the individual's face. Furthermore, during the expiratory phase, the direction of the aerosol is altered by the patient's exhaled airflow. The airflow opposite the aerosol production point carries it toward the mask's outlet, resulting in a loss of aerosol during exhalation.

[0008] Chinese patent application CN 113 181 496 discloses an inhalation system comprising a sieve nebulizer and a face mask. However, the introduction of the aerosol into the mask is not directed towards the nasal part.

[0009] The Chinese utility model CN ​​206 675 800 discloses an inhalation system comprising a nebulizer and a face mask. However, the aerosol delivered to the mask is not directed towards the nasal area.

[0010] French patent application FR 2 886 127 discloses an inhalation system comprising a nebulizer and a face mask. However, the incoming and outgoing airflows during the patient's breathing while wearing the mask are not directed towards the nasal part (for the aerosol introduced into the mask) or from the mouth part outwards (for exhalation).

[0011] Finally, the Chinese utility model CN ​​214 912 223 discloses a child-sized atomizing mask for administering medication. However, the inflow and outflow patterns during the patient's respiration while wearing the mask are not clearly described.

[0012] Furthermore, some systems, such as those described in French patent applications FR2985909 and FR2879465, are equipped with valves—possibly unidirectional—allowing air or aerosol to enter the mask through a different opening than the air outlet. However, these valves do not open instantaneously at the beginning of each inspiratory phase due to the expansion of gases within the mask, particularly for small respiratory volumes. This effect contributes to a decrease in aerosol delivery through the mask and therefore also to a reduction in the effectiveness of these systems. Moreover, in this type of system, the mask volume always represents a dead space, reducing the amount of aerosol inhaled by the patient.

[0013] Furthermore, known systems lead to aerosol deposition on the inner walls of the mask due to the coalescence effect, which causes droplets to clump together, and the condensation effect. The aerosol droplets thus deposited and lost will therefore not contribute to aerosol deposition in the lungs.

[0014] Ultimately, the seal of known systems is not optimal, implying expulsion of the aerosol outside the mask during exhalation, which leads to a risk of contamination of the ambient air.

[0015] The aim of the invention is to provide a system that avoids one or more of these problems by promoting aerosol inhalation with greater deposition efficiency in the lower respiratory tract (lungs) or by reducing contamination of outside air or deposition on the walls of the mask. SUMMARY

[0016] To this end, the present invention relates to an inhalation system comprising a mesh nebulizer and a face mask comprising: A mask body configured to cover the nose and mouth of a user when said mask body is placed on the user and delimited by a mask edge defining a surface characterized by a mean plane; a first opening comprising a tube opening into the nasal part of the mask body and comprising a first end whose intersection with the mask body defines a surface whose normal direction forms an angle greater than 10° and less than 90°, preferably less than or equal to 75° with the mean plane, and a second end connected to the mesh nebulizer; the nasal part of the mask body being the part of the mask body located, when the mask is worn by a seated or standing user, above the tip of the nose.and A second opening comprising a tube leading into the mouthpiece of the mask body and comprising a first end whose intersection with the mask body defines a surface whose normal direction forms an angle greater than 0° and less than 90° with the mean plane, the mouthpiece of the mask body being the part of the mask body located, when the mask is worn by a seated or standing user, below the lower lip.

[0017] Indeed, the use of a sieve nebulizer allows, thanks to the absence of gas injection into the aerosol, a higher yield than other known nebulizers, thus leading to an increase in the efficiency of deposition in the lower respiratory tract (or airways) (lungs).

[0018] Furthermore, because the face mask covers the user's nose and mouth, it allows for simultaneous treatment of the upper and lower respiratory tracts, as the user can inhale through both their nose and mouth. Additionally, the nebulizer, connected to the first opening in the nasal (or upper) portion of the mask body, allows the aerosol to be diffused on either side of the user's nose and directed, by gravity, towards the oral portion of the mask body during exhalation and pauses in breathing. The second opening in the oral (or lower) portion of the mask body increases the effectiveness of nebulization in the respiratory tract by allowing the inhalation of a greater proportion of the aerosol that accumulated in this oral portion of the face mask during the expiratory phase.

[0019] According to another advantageous aspect of the invention, the second opening comprising a tube includes a second end connected to a one-way valve allowing communication from the outside to the inside of the mask body, the face mask further comprising a third opening comprising a tube opening into the central part of the mask body and comprising a first end whose intersection with the mask body defines a surface whose normal direction is substantially perpendicular to the mean plane.

[0020] Indeed, the inclusion of a third opening leading into the central part of the mask body helps to limit the expulsion of the aerosol from the mask body and therefore the loss of aerosol because, thanks to the diffusion of the aerosol on either side of the user's nose, the aerosol is outside the path of the exhaled air.

[0021] This advantage is further enhanced by the use of a one-way valve in the second opening, allowing exhaled air to be directed only through the third opening.

[0022] According to another advantageous aspect of the invention, the third opening comprising a tube includes a second end connected to a one-way valve allowing communication from the inside of the mask body to the outside.

[0023] Indeed, the use of a one-way valve in the third opening allows outside air to be inhaled only through the second opening. This increases the efficiency of deposition in the respiratory tract by inhaling the air containing the highest proportion of aerosols, namely the air contained in the mouthpiece of the face mask.

[0024] According to another advantageous aspect of the invention, the longitudinal dimension of the tubes of each of the openings is less than 2 centimeters, preferably less than 1 centimeter.

[0025] Indeed, using small-diameter tubing allows for better control of the airflow entering the mask. Furthermore, the reduced overall volume of the mask enables faster activation of any one-way valves that may be present in the mask's tubing.

[0026] According to another advantageous aspect of the invention, the third opening includes a second end connected to a filter.

[0027] Indeed, the use of a filter helps to further reduce the expulsion of aerosol droplets from the mask body and therefore the contamination of the outside air.

[0028] According to another advantageous aspect of the invention, the second opening further includes an inlet intended to be connected to a dry gas source, the one-way valve of the second opening being located between said inlet and the mask body.

[0029] Indeed, using a dry gas source connected to the second opening allows, during the inspiratory phase, the inhalation of dry air or dry oxygen, which limits the condensation of water vapor on the droplets, preventing their deposition on the inner surface of the face mask. This helps to recover aerosol droplets and thus increases the effectiveness of deposition in the respiratory tract.

[0030] According to another advantageous aspect of the invention, the mask body further comprises a distributor for directing an aerosol produced by the sieve nebulizer to either side of the user's nose when the face mask is placed on the user, said distributor being positioned between the first and third openings.

[0031] Indeed, using a nasal spray nozzle directs the aerosol flow to either side of the nose, reducing the amount of aerosol deposited on the patient's nose. This contributes to decreasing outdoor air contamination and increasing the effectiveness of aerosol deposition in the respiratory tract.

[0032] According to another advantageous aspect of the invention, the mask body has a volume of less than 500 millilitres.

[0033] Indeed, this air volume corresponds to the average volume of air inhaled by an adult with each breath. This reduces the dead volume and therefore increases the proportion of aerosol inhaled.

[0034] According to another advantageous aspect of the invention, the mask body has a volume of less than 100 millilitres for use on a child.

[0035] Indeed, this air volume corresponds to the average volume of air inhaled by a child with each breath. This reduces the dead volume and therefore increases the proportion of aerosol inhaled.

[0036] According to another advantageous aspect of the invention, the edge of the mask body is made of a flexible material.

[0037] Indeed, this feature increases the seal of the mask and thus reduces contamination from the outside air.

[0038] This disclosure also relates to the use of the system according to one of the embodiments for administering a product into the respiratory tract of a user, including the steps of: Introduction of a liquid active ingredient into the sieve nebulizer, Installation of the system on the user's nose and mouth, Continuous generation of an aerosol by the sieve nebulizer, preferably with a flow rate between 0.01 and 1 milliliter / minute, preferably between 0.05 and 0.1 milliliter / minute and / or a liquid droplet size of the aerosol between 0.1 and 10 microns, preferably between 2 and 5 microns.

[0039] Indeed, using this flow rate range helps to limit aerosol loss through condensation of droplets on the internal surface of the mask.

[0040] Furthermore, a small droplet size allows for better deposition efficiency in the lower respiratory tract. DEFINITIONS

[0041] In the present invention, the terms below are defined as follows: "MMAD" Or "Median Mass Aerodynamic Diameter" Or "Mass Aerodynamic Diameter" This relates to the median value of the diameter of the aerosol droplets produced by the nebulizer. This size can be measured, for example, by a cascade impactor.

[0042] "Mouth part of a mask" concerns the part of a face mask located, when the mask is worn by a user sitting or standing, below the lower lip.

[0043] "Central part of a mask" concerns the part of a face mask located, when the mask is worn by a user, between the lower lip and the tip of the nose.

[0044] "Nasal part of a mask"concerns the part of a face mask located, when the mask is worn by a user sitting or standing, above the tip of the nose.

[0045] "Nebulization efficiency" concerns the ratio between the amount of aerosol deposited in the respiratory tract (lower and upper) in liquid form at the end of the nebulization session and the amount of liquid introduced into the nebulizer before the start of the nebulization session.

[0046] "Lung efficiency" concerns the ratio between the amount of aerosol deposited in the lower respiratory tract (lungs) at the end of the nebulization session and the amount of liquid introduced into the nebulizer before the start of the nebulization session.

[0047] "Volume of a mask"concerns the sum of the volume of the mask body completed by an average surface defined by the edge of the mask and the volume of the openings each completed by an average surface defined by the edge of its end not opening into the mask body.

[0048] "Dead volume" relates to the volume of air contained in the face mask and free of inhaled aerosol with each breath. BRIEF DESCRIPTION OF THE FIGURES

[0049] Other features and advantages of the present invention will become apparent from the description below, with reference to the accompanying drawings which illustrate non-limiting examples of embodiments. In the figures: Figure 1 shows an inhalation system according to an embodiment of the invention. Figure 2 shows the face mask according to an embodiment of the invention as it is positioned during its use. Figure 3shows the inhalation system in the embodiment in which the face mask includes three openings. Figure 4 shows the inhalation system in the embodiment in which the face mask includes three openings and two one-way valves. Figure 5 shows the inhalation system in the embodiment in which the face mask includes three openings and a filter. Figure 6 shows the inhalation system in the embodiment in which the face mask includes three openings, two one-way valves and an inlet intended to be connected to a dry air reservoir. Figure 7 shows the face mask in the embodiment in which it includes three openings and a distributor. Figure 8 shows the use of the inhalation system according to the invention during a respiratory cycle. Figure 9shows a comparison of the effectiveness of aerosol deposition in the respiratory tract using a known prior art face mask (left) and the face mask according to an embodiment of the invention (right). Figure 10A shows an aerosol flow generated in the face mask according to an embodiment of the invention while the Figure 10B shows an aerosol flow generated in a face mask known from prior art. Figure 11 shows a comparison of a known prior art face mask (left) and the face mask according to an embodiment of the invention (right). DETAILED DESCRIPTION

[0050] There figure 1 shows an inhalation system (100) comprising in particular a face mask. The face mask comprises a mask body (102), a first opening and a second opening.

[0051] The mask body (102) is configured to cover a user's nose and mouth when the system is placed on (or worn by) a user. Wearing the mask allows the mask body (102) to be virtually separated into three parts, defined according to the portion of the face covered by each part. Thus, as shown in the figure 2 , the mask body (102) includes a nasal part (hatched on the figure 2 ) extending, when the mask is worn by a user, above the tip of the nose, a mouth area (dotted on the figure 2 extending below the lower lip and a central part (checkered on the figure 2 ) between the lower lip and the tip of the nose. Equivalently, these parts can respectively correspond to the top, bottom and center of the mask, the top and bottom being defined vertically when the user wearing the mask is sitting or standing.

[0052] The mask body (102) is delimited by a mask rim, which can be defined as the part of the mask body (102) that comes into contact with the user's face when worn. Advantageously, the mask rim can be an element added to the mask body (102) and made from a flexible material. For example, the flexible material can be silicone or another soft elastomer, or even an inflatable rim that adapts to the shape of the face. This increases the mask's seal and thus reduces contamination of the outside air by the aerosol and increases the efficiency of aerosol deposition in the user's respiratory tract.

[0053] The mask edge defines a surface (in gray on the figure 1characterized by a mean plane (S). Thus, the mask body (102) and the mean plane (S) define an inner (or internal) part and an outer (or external) part of the face mask. Furthermore, the mask body (102) can also be characterized by a vertical plane, substantially perpendicular to the mean plane (S) and passing through the axis of symmetry of the user's face.

[0054] The first opening comprises a tube (104), also called a nebulizing tube, which opens into the nasal (or upper) part of the mask body (102). The tube (104) has, by definition, two ends. The end opening into the mask body (102) forms an intersection surface with it, characterized by a normal direction (N1). The normal direction (N1) forms an angle (δ) greater than 10° and less than or equal to 90° with the mean plane (S), preferably between 10° and 75°. Having an angle (δ) less than 75° is advantageous because it allows the aerosol flow to be directed longitudinally towards the patient's face and the bottom of the mask. Thus, the aerosol can quickly accumulate in the lower part of the mask due to the initial velocity of the particles and gravity. The second end of the tube (104) is connected to a mesh nebulizer (103).Thus, the mesh nebulizer is connected to the outside of the mask, allowing it to be operated while the inhalation system is in use. Furthermore, this external connection helps maintain a compact shape for the mask body, thereby minimizing its volume.

[0055] A nebulizer (or mist sprayer) transforms liquids into a cloud of extremely fine droplets (aerosol). The operation of screen nebulizers is based on the passage of liquid through the holes of the screen to generate droplets with a diameter roughly equivalent to the diameter of the holes. Screen nebulizers can have a static or vibrating membrane. In the case of a vibrating membrane screen nebulizer, the mechanical force required to force the liquid through the screen can be achieved using a vibrating piezoelectric quartz crystal. The piezoelectric quartz crystal can also be integrated with the screen. In this case, the vibration creates an extrusion effect, projecting the liquid through the holes and thus producing a calibrated aerosol.The use of a mesh nebulizer avoids the injection of gas into the aerosol and allows for a higher yield than other known nebulizers, thus increasing the effectiveness of deposition in the respiratory tract. This mesh nebulizer (103) is included in the system (100) according to the present invention.

[0056] Advantageously, the longitudinal axis of the nebulizing tube (104) can be contained within the vertical plane of the mask body (102). This is advantageous because the tube (104) is then aligned with the bridge of the user's nose. The nose then acts as a separator (or deflector), separating the aerosol projected by the nebulizer and directing it, by gravity, towards the mouthpiece of the mask body, passing along the face on either side of the user's nose. Thus, since the aerosol does not pass in front of the user's nose, it is not carried away by the user's exhaled air and is neither lost nor does it contaminate the outside air.

[0057] The second opening includes a tube (108), also called an inhalation tube, leading into the mouthpiece (or lower part) of the mask body (102). The tube (108) has, by definition, two ends. The tube may simply be a hole in the mask body, its length being the thickness of the mask body. In a particular case, the hole may also be composed of a series of holes grouped together in a relatively small area of ​​the mouthpiece of the mask body (102). This series of holes can then be considered the tube (108). The end of the tube (108) leading into the mask body (102) forms an intersection surface with the latter, characterized by a normal direction (N2). The normal direction (N2) forms an angle (α) greater than or equal to 0° and less than or equal to 90°, preferably between 10° and 75°, with the mean plane (S).This opening allows outside air to pass into the mask during inhalation by the user. The position of the intersection surface on the mask body (102) within the mouthpiece of the mask body (102), as described above, is advantageous because, due to gravity, the aerosol that entered through the first opening accumulates in the mouthpiece of the mask. The air inhaled by the user then enters through the second opening (108), which also opens into the mouthpiece of the mask. Thus, a large proportion of the aerosol that has accumulated in this lower (mouthpiece) part of the mask will be inhaled and can be deposited in the respiratory tract. Advantageously, the longitudinal axis of the tube (108) can lie in the vertical plane of the mask body (102).This is advantageous because the inhalation tube (108) is then aligned with the user's nostrils and mouth, thus allowing a more natural movement of the air breathed by the user.

[0058] In one embodiment shown at the figure 3The face mask further includes a third opening. This opening comprises a tube (106), also called an exhalation tube, which opens into the central part of the mask body (102). The tube (106) has, by definition, two ends. The tube may simply be a hole in the mask body, its length being the thickness of the mask body. The end opening into the mask body (102) forms an intersection surface with the latter, characterized by a normal direction (N3). The normal direction (N3) is substantially perpendicular to the mean plane (S). Advantageously, the longitudinal axis of the exhalation tube (106) may lie in the vertical plane of the mask body (102). This is advantageous because the tube (106) is then aligned simultaneously with the user's nostrils and mouth, thus allowing for a more natural movement of the air exhaled by the user.

[0059] When the face mask includes the third opening, the second end of the inhalation tube (108) is connected to a one-way valve (109) that allows communication only from the outside to the inside of the mask body (102). This is advantageous because the one-way valve (109) prevents exhaled air from escaping through the second opening. Thus, exhaled air exits only through the third opening, which includes the exhalation tube (106). The aerosol accumulated in the mouthpiece of the mask is therefore not expelled during exhalation.

[0060] In an advantageous embodiment represented at the figure 4The second end of the exhalation tube (106) is connected to a one-way valve (105) allowing communication from the inside of the mask body (102) to the outside. This is advantageous because the air inhaled by the user then passes only through the inhalation tube (108). Thus, this allows for the inhalation of a greater proportion of aerosol because, as explained above, the aerosol accumulates by gravity in the mouthpiece of the mask, where the second opening containing the inhalation tube (108) is located.

[0061] In an advantageous embodiment represented at the figure 5 The second end of the exhalation tube (106) is connected to a filter (107). In one specific embodiment, the filter (107) is an expiratory filter that retains fine droplets during exhalation. This is advantageous because the filter helps protect the outside air from aerosol contamination during exhalation.

[0062] The one-way valve (105) and the filter (107) can be connected separately or simultaneously to the exhalation tube (106). In one embodiment, only the one-way valve (105) is connected to the exhalation tube (106). In an alternative embodiment, only the filter (107) is connected to the exhalation tube (106). In another embodiment, both the one-way valve (105) and the filter (107) are connected to the exhalation tube (106). In this embodiment, the filter (107) can be positioned upstream of the one-way valve (105), i.e., between the one-way valve (105) and the inside of the mask body (102). This protects the valve (105) from contamination by aerosol droplets and from potential malfunction due to clogging.

[0063] In the embodiment in which the inhalation tube (108) includes a one-way valve (109), the inhalation tube (108) may further include an inlet (110), shown in the figure 6intended to be connected to a dry gas source such as a dry air or dry oxygen reservoir. The dry gas source can be a pressurized cylinder connected directly to the face mask via, for example, a corrugated tube connected to the inlet (110). In an alternative embodiment, for example in a hospital setting, the dry gas source is a central reservoir. The inlet (110) of the face mask is then connected via, for example, a corrugated tube and a wall-mounted regulator to one of the air outlets of the central reservoir. The use of dry air or dry oxygen is advantageous because it allows for more effective mask rinsing during inhalation. Indeed, the dry gas limits the condensation of water vapor on the aerosol droplets to prevent deposition on the inner wall of the mask body (102). This therefore reduces aerosol loss and increases the efficiency of aerosol deposition in the user's airways.The addition of dry gas also allows the evaporation of droplets and therefore better lung penetration.

[0064] In one embodiment shown in the figure 7The mask body (102) further includes a distributor (114) (or deflector) that more effectively directs the aerosol to either side of the user's nose and limits aerosol deposition on the user's nose. The distributor (114) can be a rigid or semi-rigid component. The distributor (114) can be reversibly attached (allowing it to be repeatedly attached and detached) inside the mask body (102). Alternatively, the distributor (114) can be permanently integrated inside the mask body (102) during its manufacture. In a specific embodiment, the distributor (114) has an arched shape. In another specific embodiment, the distributor (114) is positioned between the first opening containing the nebulizing tube (104) and the third opening containing the exhalation tube (106).In a more specific embodiment, the arc-shaped distributor is fixed so that the midpoint of the arc is positioned between the first opening containing the nebulizing tube (104) and the tip of the user's nose. This is advantageous because it allows for more even distribution of the aerosol on either side of the nose. In an even more specific embodiment, the arc-shaped distributor is extended on either side of the user's nose to create two airtight passage channels between the nose and the side walls of the mask. This is advantageous because it directs the aerosol trajectory towards the lower part of the mask and increases the efficiency of directing the aerosol on either side of the nose. The aerosol is then directed away from the path of the air exhaled by the user, which reduces the amount of aerosol ejected into the outside air.This contributes to reducing outdoor air contamination and increasing deposition efficiency in the respiratory tract.

[0065] Advantageously, the tubes (104, 106, 108) define small volumes. This is advantageous because it allows for a reduction in the mask volume. The mask volume is defined as the sum of the volume defined by the mask body (102) and the mean plane (S), and the volume of each of the tubes (104, 106, 108). A small mask volume allows, when one-way valves are present in the face mask, for faster opening of these valves by reducing the gas expansion volume. For example, the mask volume can be reduced by decreasing the length of the tubes (104, 106, 108). Thus, the longitudinal dimension of the tubes (104, 106, 108) at each of the openings can be less than 2 centimeters, preferably less than 1 centimeter. In a specific embodiment, the mask volume is substantially equal to or less than the lung capacity of an average user.For example, for an adult user, the volume of the mask may be less than 500 milliliters while for a child, the volume of the mask may be less than 100 milliliters, preferably close to 50 milliliters.

[0066] For example, the mask and tubing are made of a material such as polypropylene (PP), polyethylene (PE), or polyetheretherketone (PEEK). The mask and tubing are preferably phthalate- and PVC-free. The mask and tubing are preferably made of a material that is not prone to electrostatic charge buildup.

[0067] This disclosure also relates to the use of the system (100) described above to administer a product into the airways of a user.

[0068] The first step in operation is to introduce a liquid active ingredient into the mesh nebulizer (103). The active ingredient may be a drug used in therapeutic treatment. It may also be a pathogen or a marker used in clinical trials or research. In this case, minimizing the dispersion of the pathogen outside the mask is important, and efficient—quantitative—administration of the pathogen allows for the use of smaller quantities of hazardous substances.

[0069] The introduction of the active ingredient can be done by dissolution in the case of a liquid active ingredient or by dispersion in the case of a non-soluble active ingredient.

[0070] The system (100) is then placed over the user's nose and mouth. This is advantageous because it allows simultaneous administration to the upper and lower respiratory tracts, enabling the user to inhale through both the nose and mouth. In one specific embodiment, to increase the system's effectiveness, the user is positioned sitting, standing, or in a semi-seated / semi-reclined position.

[0071] The sieve nebulizer (103) continuously generates an aerosol containing the introduced active ingredient. Another advantage of using the sieve nebulizer is that it allows the aerosol flow rate and droplet size to be adapted to the user. Thus, in a specific embodiment, the nebulizer flow rate is between 0.01 and 1 milliliter / minute and / or the size of the aerosol droplets produced is between 0.1 and 10 microns. Preferably, the aerosol flow rate is between 0.05 and 0.5 milliliters / minute, optimally between 0.05 and 0.1 milliliters / minute. Furthermore, and regardless of the nebulizer flow rate, the size of the aerosol droplets produced is preferably between 0.5 and 5 microns, optimally between 2 and 5 microns. This is advantageous because the use of these flow ranges helps to limit the loss of aerosol through condensation of droplets on the inner wall of the mask.Furthermore, this droplet size range is small enough to allow for better deposition efficiency in the lower respiratory tract.

[0072] The continuous generation of the aerosol allows the system (100) of the present invention to be used as efficiently as possible. Indeed, a breathing cycle is divided into three phases represented in the figure 8 : expiration (P1), respiratory pause (P2) and inspiration (P3).

[0073] During exhalation (P1), the air contained in the user's respiratory tract is expelled from the mask body (102). In the embodiment of the figure 8 The mask body comprises three tubes (104, 106, and 108). The inhalation tube (108) includes a one-way valve (not shown) allowing air to flow from the outside to the inside of the mask. Exhaled air can therefore only exit the mask body (102) through the exhalation tube (106).

[0074] During the respiratory pause (P2), the aerosol (represented by a cloud of points in the figure 8 ) accumulates in the mask due to its continuous production by the mesh nebulizer (103). Advantageously, for a user standing, sitting, or semi-sitting / semi-reclining, with the nebulizing tube (104) positioned above the bridge of the nose, the aerosol produced by the mesh nebulizer (103) is mainly directed to either side of the user's nose, preferably substantially parallel to the user's face, and falls, by gravity, into the mouthpiece of the mask ( Figure 10A ). A small mask volume allows for faster mask filling.

[0075] In known face masks, the aerosol is sent into the mask via an opening located in the central part of the mask body and perpendicular to the mean plane (S) ( figure 10BTherefore, the aerosol flow is not directed from either side of the bridge of the nose towards the mouthpiece of the mask. Consequently, no accumulation in the mouthpiece of the mask is possible because the aerosol flow is directed perpendicular to the force of gravity. During the inspiratory pause (P2), the aerosol flow does not have time to change direction and move towards the mouthpiece of the mask. This reduces the effectiveness of deposition in the airways.

[0076] During inhalation (P3), outside air is drawn in through the inhalation tube (108). In the embodiment where the exhalation tube (106) does not include a one-way valve, air can also be drawn in through the exhalation tube (106). The mask is then rinsed by the inhaled air, and the aerosol droplets are then inhaled and deposited in the user's respiratory tract.

[0077] A similar result is obtained when system (100) is used on a person lying down. EXAMPLES

[0078] The present invention is also illustrated by the following examples. The equipment used and the results of Examples 1-3 are summarized in Table 1. [Table 1]

[0079] Experimental results Table 1 Example 1 Example 2 Example 3 INV AA INV AA AA INV INV Condition In vivo In vivo In vitro In vitro In vivo In vitro In vitro In vivo Mask Fig. 3 Fig. 3 Fig. 3 AA AA Fig. 3 Fig. 3 Fig. 3 Nebulizer Static sieve Micro Cirrus ™< Static sieve Static sieve Static sieve Static sieve Static sieve Vibrating sieve Flow rate (mL / min) 0,8 0,7 0,5 07 0,7 1 0,2 0,08 Droplet size (µm) 4 4 4,2 4,2 4,2 3,2 3,2 3,2 Nebulization efficiency (%) 36 2,8 27 9 16 29 52 41 Lung efficiency (%) 12,5 0,5 24 7 6 25 43 17 Example 1 Comparison of nebulization efficiencies:

[0080] In this example, the nebulization efficiency is compared, after a 10-minute nebulization session, between an inhalation system according to the implementation method of the figure 3 of the invention (INV) – that is, comprising a mesh nebulizer and a face mask with three openings – and a system comprising the same face mask and a commercial Micro Cirrus™ (AA) type pneumatic nebulizer. The mesh nebulizer includes a static membrane producing a 4-micron MMAD radioactive aerosol at a flow rate of 0.8 mL / minute. The pneumatic nebulizer operates using a compressed air source introduced at a flow rate of 8 liters / minute and produces a 4-micron MMAD radioactive aerosol at a flow rate of 0.7 mL / minute. These radioactive aerosols were administered to three non-human macaque primates.

[0081] The results showed a nebulization efficiency in the macaques' airways of 2.8% with the pneumatic nebulizer (AA) and 36% with the mesh nebulizer (INV) according to the invention. The pulmonary efficiency was 0.5% with the pneumatic nebulizer (AA) and 12.5% ​​with the mesh nebulizer (INV).

[0082] The use of a mesh nebulizer therefore effectively increases nebulization efficiency and deposition in the lungs compared to a pneumatic nebulizer. The system according to the invention, comprising a mesh nebulizer, thus effectively increases nebulization efficiency. Example 2 : Comparison with known face masks

[0083] In this example, the deposition rate is compared after a 10-minute nebulization session with a mesh nebulizer producing a 4.2-micron MMAD aerosol, connected successively to two different face masks. The first mask, known from the prior art (AA), is an embodiment of the mask described in French patent application FR 2985909. It is equipped with one-way valves and a storage chamber connected to one of the one-way valves on one side and to the mask body on the other. The aerosol is produced in the storage chamber. During the expiratory phase, the user exhales air through the one-way valve not connected to the storage chamber. During inhalation, the aerosol accumulated in the storage chamber is inhaled by the user using the air drawn in through the second one-way valve. With this mask, the flow rate of the mesh nebulizer is 0.7 mL / minute.The second face mask (INV) is the face mask according to the embodiment shown in the figure. figure 3 comprising three openings and a sieve nebulizer producing an aerosol with a flow rate of 0.5 mL / minute.

[0084] Aerosols were administered to an in vitro anatomical model of Vervet monkey connected to a respiratory pump simulating the animal's breathing (25 mL, 30 breaths / minute, inspired air volume (I) equal to the exhaled air volume € - I / E=1).

[0085] In vitro results showed a nebulization efficiency in the airways of 9% with the first system (AA) and 27% with the second system (INV). Pulmonary nebulization efficiency was 7% with the first system (AA) and 24% with the second system (INV).

[0086] The aerosol was also administered to three non-human macaque primates (in vivo) with the known prior art (AA) mask and with a nebulization rate of 0.7 mL / minute.

[0087] The distribution of aerosol deposition in the lower and upper respiratory tracts of the three macaques (in vivo, measured by scintigraphy) is shown on the left side of the figure 9 In the greyscale image, the larger the deposit, the darker the area. In vivo results showed a 16% airway efficiency and a 6% pulmonary efficiency.

[0088] The system according to the invention therefore makes it possible to increase the nebulization efficiency and the deposition in the lungs compared to a pneumatic nebulizer compared to a system comprising a face mask known from the prior art. Example 3 Efficiency as a function of flow rate

[0089] In this example, an initial comparison of the in vitro nebulization efficiency is performed after two nebulization sessions using the system according to the implementation method of the figure 3 (INV) – that is, comprising three openings and a mesh nebulizer. At each nebulization session, the droplet size produced by the nebulizer is identical, while the nebulization flow rate differs. Thus, during the first session, the mesh nebulizer produces a 3.2-micron aerosol at a flow rate of 1 mL / minute, while during the second session, the mesh nebulizer produces a 3.2-micron aerosol at a lower flow rate of 0.2 mL / minute. The aerosols were administered to an in vitro anatomical model of a Vervet monkey connected to a respiratory pump simulating the animal's respiration (25 mL, 30 breaths / minute, I / E=1).

[0090] In vitro results showed a nebulization efficiency in the airways of 29% with the highest flow rate and 52% with the lowest flow rate. Pulmonary nebulization efficiency was 25% with the highest flow rate and 43% with the lowest flow rate.

[0091] The nebulization efficiency was also measured in vivo after a nebulization session using the system according to the implementation method of the figure 3 (INV) – that is, comprising three openings and a sieve nebulizer. The sieve nebulizer produces a radioactive aerosol of 3.2 microns at an even lower flow rate of 0.08 mL / minute. The aerosol was administered to three non-human macaque primates.

[0092] The distribution of aerosol deposition in the lower and upper respiratory tracts of the three macaques (in vivo, measured by scintigraphy) is shown on the right side of the figure 9 In the greyscale image, the larger the deposit, the darker the area. In vivo results showed a respiratory tract efficiency of 41% and a pulmonary efficiency of 17%.

[0093] This example clearly demonstrates that a lower flow rate results in higher nebulization efficiency. Since the invention is used with a low flow rate (between 0.01 and 1 mL / minute, preferably between 0.05 mL / minute and 0.5 mL / minute), this allows for greater nebulization and pulmonary efficiency. Example 4 Comparison of nebulization efficiencies as a function of the position of the first opening

[0094] In this example, the nebulization efficiency is compared, after a 10-minute nebulization session, between an inhalation system according to the implementation method of the figure 3 of the invention - that is to say comprising a mesh nebulizer and a face mask comprising three openings - shown on the right of the figure 11 and a system comprising the same nebulizer but mounted on a face mask comprising only two openings, the opening of which, connected to the nebulizer, is positioned in the central part of the mask body as shown on the left of the figure 11 This latter system therefore sends the aerosol perpendicularly to the subject's face.

[0095] The sieve nebulizer includes a static membrane producing a radioactive aerosol of 4 microns MMAD at a flow rate of 0.8 mL / minute. This radioactive aerosol was administered to three non-human macaque primates.

[0096] The nebulization efficiencies for each of the two masks were measured. The results show that the face mask with only two openings delivers only 12% of the dose to the respiratory tract, while the mask on the right, according to the invention, delivers 54% of the dose. The placement of the first opening and the distance between the first and second openings therefore significantly improve nebulization efficiency.

Claims

1. An inhalation system (100) comprising a mesh nebulizer (103) and a face mask comprising: - a mask body (102) configured to cover the nose and the mouth of a user when said mask body (102) is placed on the user and bounded by a mask edge defining a surface characterized by a mean plane (S), - a first opening comprising a tube (104) opening into the nasal portion of the mask body (102) and comprising a first end whose intersection with the mask body (102) defines a surface whose normal direction (N1) forms an angle (δ) greater than 10° and less than or equal to 90°, preferably less than or equal to 75°, with the mean plane (S), and a second end connected to the mesh nebulizer (103), the nasal portion of the mask body (102) being the part of the mask body (102) located, when the mask is worn by a seated or standing user, above the tip of the nose, and - a second opening comprising a tube (108) opening into the buccal portion of the mask body (102) and comprising a first end whose intersection with the mask body (102) defines a surface whose normal direction (N2) forms an angle (α) greater than 0° and less than or equal to 90° with the mean plane (S), the buccal portion of the mask body (102) being the part of the mask body (102) located, when the mask is worn by a seated or standing user, below the lower lip.

2. The system (100) according to claim 1, wherein the second opening comprising a tube (108) comprises a second end connected to a one-way valve (109) allowing communication from the outside to the inside of the mask body (102), the face mask further comprising a third opening comprising a tube (106) opening into the central portion of the mask body (102) and comprising a first end whose intersection with the mask body (102) defines a surface whose normal direction (N3) is substantially perpendicular to the mean plane (S).

3. The system (100) according to claim 2, wherein the third opening comprising a tube (106) comprises a second end connected to a one-way valve (105) allowing communication from the inside of the mask body (102) to the outside.

4. The system (100) according to claim 2 or 3, wherein the longitudinal dimension of the tubes of each of the openings (104, 106, 108) is less than 2 centimeters, preferably less than 1 centimeter.

5. The system (100) according to any one of claims 2 to 4, wherein the third opening (106) comprises a second end connected to a filter (107).

6. The system (100) according to any one of claims 2 to 5, wherein the second opening (108) further comprises an inlet (110) intended to be connected to a dry gas source, the one-way valve (109) of the second opening (108) being located between said inlet (110) and the mask body (102).

7. The system (100) according to any one of claims 2 to 6, wherein the mask body (102) further comprises a deflector (114) allowing an aerosol produced by the mesh nebulizer (103) to be directed on either side of the user's nose when the face mask is placed on the user, said deflector (114) being positioned between the first opening (104) and the third opening (106).

8. The system (100) according to any one of claims 1 to 7, wherein the mask body (102) has a volume of less than 500 milliliters.

9. The system (100) according to any one of claims 1 to 8, wherein the edge of the mask body (102) is made of a flexible material.