Patent Publication Number: US-2020282160-A1

Title: Device for inhalation-synchronised dispensing of a fluid product

Description:
The present invention relates to a fluid dispenser device in which dispensing is synchronized with inhaling, and more particularly it relates to an inhaler device of the aerosol type synchronized with inhaling. 
     Breath actuated inhaler (BAI) devices are well known in the state of the art. The main advantage of this type of device is that the dispensing of fluid is synchronized with the patient inhaling, so as to guarantee that the fluid is properly dispensed into the airways. Thus, in the field of aerosol devices, i.e. devices in which the fluid is dispensed by means of a propellant gas, numerous types of breath actuated inhaler device, have been proposed. However, those devices present the drawback of including a large number of parts, i.e. they are complicated and costly to manufacture and to assemble, which is obviously disadvantageous. It is also difficult to find the right balance between reliable triggering on each inhalation, without the trigger threshold being too high, and a latch that is robust enough to prevent accidental or unwanted actuation. Unfortunately, when the latch releases accidentally, the device is actuated automatically and the dose is dispensed, even when the user does not want it. 
     Thus, in order to dispense the dose properly, what is more important than actuating the device automatically, is for dispensing to be synchronized with the user inhaling, even if actuation or triggering remains manual. 
     Documents FR 2 775 668, WO 2017/178764, WO 2017/178765, and WO 2017/178768 describe prior-art devices. 
     A drawback of those devices resides in the risk of the device jamming if the actuation force of the user is too great, i.e. if the user exerts an axial actuation force on the end wall of the reservoir that is too great. 
     An object of the present invention is to provide an inhalation-synchronized fluid dispenser device that does not have the above-mentioned drawbacks. 
     Another object of the present invention is to provide an inhalation-synchronized fluid dispenser device that improves operational reliability by guaranteeing effective actuation on each inhalation, without risk of jamming. 
     Another object of the present invention is to provide an inhalation-synchronized fluid dispenser device that minimizes the risks of accidental or unwanted actuation. 
     Another object of the present invention is to provide an inhalation-synchronized fluid dispenser device that does not present a trigger threshold that is too high, thereby making it possible for people who are relatively weak, such as the sick or the elderly, to use the device in safe and reliable mariner. 
     Another object of the present invention is to provide an inhalation-synchronized fluid dispenser device that is simple and inexpensive to manufacture and to assemble. 
     The present invention thus provides an inhalation-synchronized fluid dispenser device comprising a body provided with a mouthpiece, a fluid reservoir containing a fluid and a propellant gas being mounted to slide axially in said body, a metering valve including a valve member being assembled on said reservoir for selectively dispensing the fluid, said device further comprising: 
     a blocking element that is movable and/or deformable between a non-actuation position in which said metering valve cannot be actuated, and an actuation position in which said metering valve can be actuated, said blocking element, in its non-actuation position, co-operating firstly with the body and secondly with the reservoir so as to prevent said reservoir from moving axially in the body; and 
     an inhalation-controlled trigger system including an inhalation-sensitive member that is deformable and/or movable under the effect of inhaling, said inhalation-sensitive member, when it is deformed and/or moved, moving and/or deforming said actuator element from its non-actuation position towards its actuation position; 
     said device including an actuator that is fastened on said reservoir, said actuator comprising a proximal wall that is fastened, in particular force-fitted, on the end of the reservoir, a body that slides axially past said proximal wall, and a spring that is arranged between said proximal wall and a distal wall of said body, said body sliding axially past said proximal well between a rest position and a cocked position in which said spring is compressed, such that on said inhalation-controlled trigger system being actuated, said compressed spring moves said reservoir axially in said body so as to actuate said metering valve. 
     Advantageously, said blocking element is a blocking ring that is fastened, in particular snap-fastened, on said reservoir, and that includes at least one axial tab, in particular three axial tabs, co-operating with a shoulder that is secured to said body so as to prevent said reservoir from moving axially in said body. 
     Advantageously, said at least one axial tab is deformable radially outwards so as to pass from the non-actuation position towards the actuation position, a trigger element being provided so as to hold said at least one axial tab in the non-actuation position. 
     Advantageously, said trigger element is mounted to move between a blocking position in which it blocks said blocking element in its non-actuation position, and a release position in which it does not block said blocking element. 
     Advantageously, said inhalation-sensitive member of said inhalation-controlled trigger system includes a deformable membrane that defines a deformable air chamber, said deformable membrane being fastened to said trigger element, said deformable membrane being deformed during inhaling, so that it moves said trigger element from its blocking position towards its release position. 
     Advantageously, said spring is a coil spring. 
     In a variant, said spring may be a plastics spring. 
     In a variant, said spring may be a foam element. 
     Advantageously, said the actuator includes a radial flange that extends radially outwards on either side of said body. 
     Advantageously, the rest position of said actuator is defined by an axial abutment that is formed between a bottom axial edge of said proximal wall and an inner radial shoulder of said body. 
     Advantageously, the cocked position of said actuator is defined by an axial abutment that is formed between a bottom axial edge of said body and a top axial edge of an inner sleeve that is secured to said body. 
    
    
     
       These and other characteristics and advantages appear more clearly from the following detailed description, given by way of non-limiting example, and with reference to the accompanying drawings, in which: 
         FIG. 1  is a diagrammatic section view of a fluid dispenser device, shown in its rest position; 
         FIG. 2  is a view similar to the view in  FIG. 1 , shown in the non-dispensing position before suction; 
         FIG. 3  is a larger-scale view of a detail A in  FIG. 2 ; 
       FIG. A is a larger-scale view of a detail B in  FIG. 2 ; 
         FIG. 5  is a view similar to the view in  FIG. 2 , shown in the position after suction; 
         FIG. 6  is a view similar to the view in  FIG. 5 , shown in the position for dispensing a dose of fluid; 
         FIG. 7  is a larger-scale detail view of a portion of  FIG. 1 ; 
         FIG. 8  is a diagrammatic perspective view of the  FIG. 1  actuator; 
         FIG. 9  is a diagrammatic plan view of the  FIG. 1  actuator; 
         FIG. 10  is a diagrammatic section view of the  FIG. 1  actuator; and 
         FIG. 11  is a view similar to the view in  FIG. 10 , showing a variant embodiment. 
     
    
    
     In the description, the terms “top”, “bottom”, “upwards”, and “downwards” are relative to the position of the device as shown in particular in  FIG. 1 . The terms “axial” and “radial” are relative to the vertical central axis X shown in particular in  FIG. 1 . The terms “proximal” and “distal” are relative to the mouthpiece. 
     The invention applies more particularly to inhaler devices of the aerosol-valve type for oral dispensing, as described in greater detail below, but it could also apply to other types of inhaler device, e.g. of the nasal type. 
     The figures show an advantageous embodiment of the invention, but naturally one or more of the component parts described below could be made in some other way, while providing functions that are similar or identical. 
     With reference to the drawings, the device includes a main body  10  provided with a mouthpiece  400 . The mouthpiece  400  defines a dispenser orifice through which the user inhales while the device is being used. A removable protective cap  410  may be provided on said mouthpiece  400 , in particular while it is being stored, that the user removes before use.  FIG. 1  shows such a protective cap that could be of any shape. 
     An inner sleeve  800  may be provided inside said body  10 , as can be seen in the figures. 
     The body  10  contains a reservoir  100  that contains the fluid to be dispensed and a propellant gas, such as a gas of the hydrofluoroalkane (HFA) type, a metering valve  200  being mounted on said reservoir  100  for selectively dispensing the fluid. The metering valve  200  comprises a valve body  201 , and a valve member  210  that, during actuation, is axially movable relative to said valve body  201 , and thus relative to said reservoir  100 . The metering valve  200  can be of any appropriate type. It may be fastened to the reservoir  100  via a fastener element, preferably a crimped cap  5 , preferably with a neck gasket  4  interposed therebetween. 
     Advantageously, during actuation, the valve member  210  is stationary relative to the body  10 , and it is the reservoir  100  that is moved axially relative to the body  10  between a distal position, which is the rest position, and a proximal position. In the embodiment in the figures, the reservoir slides axially inside said inner sleeve  800 . 
     The outlet orifice of the valve member  210  of said metering valve  200  is connected via a channel  300  to said mouthpiece  400  through which the user inhales the fluid to be dispensed. In known manner, said valve member  210  is received in a valve well  700  that defines said channel  300 , at least in part. The valve well  700  may be formed integrally with the body  10 , or, as in the embodiment shown, it may be formed by a part that is assembled on said body  10 . 
     In the invention, the device includes an actuator  20 . The actuator  20  is mounted, in particular force-fitted, on the end of the reservoir  100 , and it includes a spring  21  that is adapted to be compressed when the user presses axially on said actuator  20 . The spring  21  may be a conventional coil spring, as shown in particular in  FIG. 10 , or, in a variant, a plastics spring or a foam element, as can be seen in  FIG. 11 . The actuator  20  makes it possible to guarantee an actuation force for actuating the valve  200  that is well controlled, reproducible, and independent of the actuation force exerted by the user. It is always the compressed spring  21  that moves the reservoir  100  axially so as to actuate the valve  200 . This makes it possible in particular to avoid any risk of jamming that could occur if the user exerts an actuation force that is too great. 
     As can be seen in particular in  FIGS. 10 and 11 , the actuator  20  comprises a proximal wall  22  that is fastened, in particular force-fitted, on the end of the reservoir  100 , and a body  23  that extends around said proximal wall  22  and slides axially past it, with the spring  21  arranged between said proximal wall  22  and a distal wall  24  of said body  23 . Firstly, said body  23  slides axially past said proximal wail  22  between a rest position, shown in  FIGS. 1, 10, and 11 , and a cocked position, shown in  FIGS. 2 and 5 , in which said spring  21  is compressed as much as possible. Secondly, said body  23  slides axially past said proximal wall  22  between said cocked position and an actuated position, shown in  FIG. 6 , in which the spring  21  has transmitted its force, so as to move the reservoir  100  in the body  10 , so as to actuate the valve  200 . 
     Advantageously, the actuator  20  may include radial lugs  25  that extend radially outwards on either side of the body  23 , making it easier for the user to press axially. Naturally, the radial lugs  25  are not essential, and the user can press axially on said distal wall  24  of the body  23 . 
     In the embodiment shown in the figures, the rest position of the actuator  20  is advantageously defined by an axial abutment that is formed between a bottom axial edge  29  of said proximal wall  22  and an inner radial shoulder  26  of the body  23 . The cocked position is advantageously defined by an axial abutment that is formed between a bottom axial edge  27  of the body  23  and a top axial edge  801  of the inner sleeve  800 . In a variant, the axial abutment of the cocked position could also be formed with a top axial edge of the body  10 . 
     The device includes a blocking element  500  that is movable and/or deformable between a non-actuation position in which said metering valve  200  cannot be actuated, and an actuation position in which said metering valve  200  can be actuated. In the rest position, said blocking element  500  is in its non-actuation position, and it is the user inhaling through the mouthpiece  400  that moves and/or deforms said blocking element  500  towards its actuation position. In other words, so long as the user does not inhale, it is impossible to actuate the metering valve  200 , and it is only when the user inhales that said metering valve  200  can be actuated. 
     As described in greater detail below, the blocking element  500 , in its non-actuation position, prevents the reservoir  100  from moving axially in the body  10 . During inhaling, the blocking element  500  is moved and/or deformed so that it no longer prevents the reservoir  100  from moving axially in the body  10 . Thus, after inhaling, such axial movement of the reservoir  300  causes the metering valve  200  to be actuated and a dose of fluid to be dispensed, synchronously with the inhaling. 
     Thus, in the absence of inhaling, there is no risk of an active dose of fluid being lost by accidental or incomplete actuation during which the user does not inhale. Actuating the valve  200  and expelling a dose of fluid are thus possible only when the user inhales and the reservoir  100  is moved simultaneously in the body  10  so as to actuate the valve  200 . 
     The device includes a trigger system that is controlled by the user inhaling, and that is for moving and/or deforming said blocking element  500  from its non-actuation position towards its actuation position, when the user inhales through the mouthpiece  400 . 
     The trigger system includes an inhalation-sensitive member  60  that is deformable and/or movable under the effect of inhaling, the inhalation-sensitive member  60  being adapted, when it is deformed and/or moved, to move and/or deform said blocking element  500  from its non-actuation position towards its actuation position. 
     As described in greater detail below, the inhalation-sensitive member  60  may be made in the form of a deformable air chamber, e.g. a bellows or a deformable pouch. 
     Advantageously, the non-actuation position corresponds to a position in which the reservoir  100  is blocked in the body  10 . In this blocked position, the reservoir  100  is prevented from moving by said blocking element  500  that is released only at the moment of inhaling. 
     The blocking element  500  is advantageously formed by a blocking ring that includes at least one, and preferably three, axial blocking tabs  501  that are elastically deformable radially outwards. The blocking ring is fastened, in particular snap-fastened, on the reservoir  100 , in particular on the cap  5  that fastens the metering valve  200  on the reservoir  100 . In the rest position, said blocking tabs  501  bear against a radial shoulder  710  (as can be seen more clearly in  FIGS. 4 and 7 ) of said valve well  700 . The radial shoulder  710  preferably slopes downwards and radially outwards, forming an angle y with the longitudinal central axis X of the valve  200 , such that when the reservoir  100  slides axially in the body  10  during actuation, said axial blocking tabs  501  slide over said sloping shoulder  710 , thereby deforming them radially outwards. 
     Advantageously, the angle y is greater than 20°, preferably greater than 30°, and it is naturally less than 90°. 
     A trigger element  600  is mounted around said valve well  700  to slide axially between a blocking position in which it blocks said blocking element  500  in its non-actuation position, and a release position in which it no longer blocks said blocking element  500 . In particular, said trigger element  600 , in its blocking position, co-operates with said blocking tabs  501 , preventing any deformation radially outwards of said blocking tabs  501 . Thus, when said trigger element  600  is in its blocking position, it prevents said blocking tabs  501  from deforming radially outwards, which blocking tabs consequently remain blocked axially by said shoulder  710  of the valve well  700 , thereby preventing the reservoir  100  from moving axially and the metering valve  200  from thus being actuated. Advantageously, the surface  610  of the trigger element  600  chat co-operates with said blocking tabs  501  in its blocking position, slopes and forms an angle x with the longitudinal central, axis X of the valve  200 , as shown in  FIG. 7 . The angle x is advantageously less than 30°, preferably less than 15°. 
     In the specifications required, it is possible to optimize the angles x and y so as to make it easier to actuate the inhalation-controlled trigger system. 
     The trigger element  600  is connected to said inhalation-controlled trigger system, in particular to said inhalation-sensitive member  60 , so that when said inhalation-sensitive member deforms and/or moves, it causes said trigger element  600  to pass from its blocking position towards its release position. 
     In its blocking position, the trigger element  600  advantageously co-operates in substantially airtight manner with the outside of the valve well  700 , so as to use most of the inhalation flow to actuate the inhalation-controlled trigger system. When the trigger element  600  leaves its blocking position and moves towards its release position, it opens an air passage around said valve well, as can be seen in  FIGS. 5  and  6 . This facilitates inhaling by drawing in air, thereby improving dose-taking effectiveness. In addition, drawing air in this way makes the inhaling process more comfortable for the user. 
     The trigger element  600  is advantageously fastened to an outer sleeve  650  that forms a cover and that slides axially over the outside of the body  10 . The cover  650  co-operates with an opening  13  for substantially opening the opening  13  in the blocking position, and for substantially closing the opening  13  in the release position. Since the opening  13  is open at the start of inhaling, it enables the inhalation trigger system, and in particular the inhalation-sensitive member  60 , to be actuated reliably, by avoiding any suction outside said inhalation-sensitive member  60  when it deforms. This makes it possible to optimize such triggering by inhaling. When the trigger element  600  is moved axially towards its release position under the effect of inhaling, and thus when the metering valve  200  can be actuated so as to dispense a dose of fluid, the cover  650  closes the opening  13 . 
     Advantageously, said cover  650  is accessible from the outside. This makes it possible, if necessary, to move the trigger element  600  manually, so as to be able to actuate the metering valve  200  even without inhaling, e.g. when the person that needs to receive the dose of fluid is incapable of inhaling sufficiently. This is thus a safety measure. 
     The inhalation-sensitive member  60  is advantageously made in the form of a deformable air chamber. Advantageously, the air chamber comprises a deformable membrane that is connected firstly to the body  10  and secondly to said trigger element  600 . 
     During inhaling, the deformable membrane of the inhalation-sensitive member  60  deforms and/or contracts under the effect of the suction generated by inhaling, causing the trigger element  600  to move from its blocking position towards its release position. This then enables said blocking tabs  501  to deform radially, and thus enables said blocking element  500  to move from its non-actuation position towards its actuation position. The figures show a deformable membrane made in the form of a pouch or a diaphragm, but said membrane could be made in some other way, e.g. in the form of a bellows. Naturally, other forms can also be envisaged. 
     The valve  200  is thus actuated only at the moment of inhaling, such that the dose of fluid is expelled out of the dispenser orifice simultaneously with inhaling. 
     When the user wishes to use the device, the user places the mouthpiece  400  in the mouth, and presses manually on the actuator  20 . The actuator can thus slide axially past the reservoir  100  between its rest position. and its cocked position so as to compress the spring  21 , until the actuator  20  comes into abutment with the body  10 , as can be seen in  FIG. 2 . The compressed spring  21  exerts an axial force on the reservoir  100  via said proximal wall  22 , but said reservoir  100  is blocked and prevented from sliding in the body  10  by the blocking tabs  501  of the blocking element  500 , which blocking tabs bear against the shoulder  710  of the valve well  700 . Optionally, the reservoir  100  may perform an initial short axial stroke before becoming blocked, this initial short stroke however being insufficient to actuate the metering valve  200 .  FIG. 1  shows the device at rest, and  FIG. 2  shows the device in the position with the reservoir  100  blocked, after the actuator  20  has been cocked and before inhaling. 
     When the user inhales through the mouthpiece  400 , the inhalation-sensitive member  60  deforms, and this causes the trigger element  600  that is fastened to said inhalation-sensitive member  60  to slide, as can be seen in  FIG. 4 . The movement of the trigger element  600  over the valve well  700  releases the tabs  501  of the blocking element  500  radially. Under the effect of the axial force transmitted by the spring  21  of the actuator  20  to the reservoir  100 , the axial tabs  501  are able to deform radially outwards, and thus pass over said shoulder  710 , so as to enable the reservoir  100  to slide towards its dispensing position, and the valve  200  thus to be actuated. The dispensing position is shown in  FIG. 6 . 
     At the end of inhaling, the trigger element  600  is returned upwards by the springiness of the membrane of the inhalation-sensitive member  60 . If necessary, the trigger element can also be returned manually to its rest position, by sliding the cover  650  axially upwards. 
     When the user releases the pressure on the actuator  20 , the reservoir  100  returns towards the rest position under the effect of the return spring of the valve  200 , and the valve member  210  of the metering valve simultaneously returns to the rest position, once again filling the valve chamber with a new dose of fluid. In parallel, the actuator  20  also returns to its rest position under the effect of the spring  21 . The device is thus ready for another utilization. 
     It should be observed that with the actuator  20 , the device can also be actuated correctly when the user inhales before pressing on the actuator. Nevertheless, in order to optimize the inhalation-synchronized dispensing of a dose, it is preferable for the actuator  20  to be in its cocked position when the user starts inhaling. 
     The present invention applies, in particular, to treating asthma attacks or chronic obstructive pulmonary disease (COPD), by using formulations of the following types: salbutamol, aclidinium, formoterol, tiotropium, budesonide, fluticasone, indacaterol, glycopyrronium, salmeterol, umeclidinium bromide, vilanterol, olodaterol, or striverdi, or any combination of these formulations. 
     The present invention is described above with reference to an advantageous embodiment, but naturally any modification could be applied thereto by the person skilled in the art, without going beyond the ambit of the present invention, as defined by the accompanying claims.