Improved valve

Abstract

An inhalation device for generating an aerosol of a medically active liquid, the inhalation device comprising a check valve (4); a housing (1); a reservoir (2) within the housing (1) for storing the medically active liquid (L); a pumping unit (3) downstream of the reservoir (2) for generating pressure, the pumping unit being connected to mechanical energy delivery means (6) which deliver mechanical energy to the pumping unit (3); and a nozzle (5) downstream of the pumping unit (3); wherein the pumping unit (3) comprises a hollow cylindrical part (3A) and a piston (3B), the cylindrical part (3A) having an inner space (3C) configured to receive an end (3B ') of the piston (3B), and wherein the cylindrical part (3A) and the piston (3B) are linearly movable relative to each other, thereby forming a pumping chamber (3D) having a variable volume.

Description

Technical Field

[0001] The present invention relates to the field of inhalation devices for liquids. In particular, the present invention relates to a pumping unit for an inhalation device, the pumping unit having a piston that moves relative to a pumping chamber to generate a pumping pressure. Background Art

[0002] Sprayers or other aerosol generators for liquids have long been known in the art. Such devices are particularly used in medicine and treatment. They are used as inhalation devices in medicine and treatment for applying active ingredients in the form of aerosols (i.e., small droplets embedded in a gas). Such inhalation devices are known from document EP0627230B1, for example. The basic components of such inhalation devices are: a reservoir, wherein a liquid to be aerosolized is contained; a pumping unit, for generating a sufficiently high pressure for atomization; and an atomizing device in the form of a nozzle. A pumping unit is defined as a unit, device or component capable of moving or compressing a fluid material, and it includes at least one pumping chamber, and optionally also includes auxiliary components, such as a valve body, an interface, etc. With the aid of a pumping unit, liquid will be drawn out from the reservoir in discrete amounts (i.e., discontinuously) and fed to the nozzle. The pumping unit works without a propellant and mechanically generates pressure.

[0003] The inhalation device utilizes a fixed pumping chamber into which a movable hollow piston can be inserted to reduce the internal volume of the chamber, thereby increasing the pressure inside the chamber and the piston, ultimately causing atomization of the liquid from the nozzle. By withdrawing the piston from the chamber again, its internal volume increases, and the resulting negative pressure causes liquid to be drawn from the reservoir into the chamber, so that a new atomization cycle can begin.

[0004] The improvement of this suction device is disclosed in the international patent application WO2018 / 197730A1 submitted by the same applicant as the present invention, and its content is fully incorporated herein. According to this improvement, the suction device provides a fixed piston and a movable pumping chamber with a hollow cylindrical part. By pressing the cylindrical part onto the hollow piston, the pressure in the pumping chamber increases and the liquid is pressed out of the nozzle. By pulling the cylindrical part out from the piston, the pressure becomes negative pressure and fresh liquid is sucked into the increasing volume of the chamber.

[0005] Usually, in order to prevent the liquid from flowing back from the pumping chamber to the reservoir during the high pressure stage, a check valve is fluidly located between the pumping chamber and the reservoir. When the pressure in the pumping chamber increases, the check valve closes so that the pressurized liquid can only flow toward the nozzle.

[0006] As valve, preferably a ball valve is used, which comprises a movable valve body and a valve seat, which is correspondingly shaped to provide adequate sealing when the valve body is pressed against the valve seat in the high-pressure phase. In contrast, in the refilling (low-pressure) phase, the valve body leaves the valve seat, allowing liquid to pass from the reservoir into the pumping chamber through the valve. The area or volume in which the valve body must move in order to fulfill its task is referred to below as the "working area".

[0007] However, measures must be taken to prevent the movable valve body from leaving the working area and entering the pumping chamber, as such uncontrolled movement could jam the device and / or damage the valve body, which is usually fragile due to its very small and delicate shape. To this end, the valve body is located within a "cage" formed by an obstruction structure located at the downstream end of the working area.

[0008] When the low-pressure phase begins, the valve body is at its farthest distance from the valve seat. As a result, the amount of liquid located between the valve seat and the valve body will pass through the valve seat before the ball is transported backwards by the liquid and finally contacts the valve seat, thereby closing the valve. This amount of liquid does not contribute to atomization because it is transported back and forth; therefore, it can be called a "dead volume" and, in general, should be minimized. Although the distance must have a certain minimum size in order to provide a sufficiently low flow resistance, a gap that is too large between the valve body and the valve seat will not further reduce the flow resistance in the downstream direction, but when the liquid flows in the upstream direction, it will increase the amount of the liquid volume during valve closing, that is, the aforementioned "dead volume". Therefore, when the valve is open, the position of the obstruction structure is preferably close to the valve body, and it is preferred to leave as small a gap as possible between the valve body and the valve seat.

[0009] If the outer wall of the pumping chamber is made of a deformable material such as metal or a thermoplastic synthetic material, the obstruction structure can be formed by simply pressing into the outer wall of the pumping chamber. This simple technical solution has the advantage that no additional components are required. However, the position and depth of the indentation must be precisely controlled, which is difficult to achieve and reproduce. In addition, forming the indentation requires an additional manufacturing step.

[0010] Another technical solution for providing an obstruction structure is based on the insertion of an additional mechanical component, such as a ring or a grille leaving one or more openings smaller than the effective diameter of the valve body. The component is located downstream of the valve body at the desired end of the working volume. As a result, the inner diameter of the tube in which the valve body is movably arranged is reduced and the valve body cannot pass over the obstruction component. The advantage of using an additional mechanical component is that the control over the size of the working area is improved. The disadvantage of this technical solution is that the formation and precise insertion of such a component are difficult to achieve. Furthermore, for the insertion, at least one additional manufacturing step is required. In addition, if measures are not taken to keep the component firmly in place, the component may move along the tube, causing the volume of the working area to increase or decrease. As a result, such movement may lead to an undesirable increase in the "dead volume" or inhibit any valve body movement, so that the valve is continuously closed.

[0011] Purpose of the Invention

[0012] The object of the present invention is to provide a device which avoids the disadvantages of the prior art.

[0013] More specifically, the valve should have a precisely controllable, stable working area size. The dead volume should be easily minimized, and as few additional working steps as possible should be required to achieve the improved valve. Summary of the invention

[0014] According to a first aspect, the present invention provides an inhalation device for generating an aerosol of a medically active liquid and for inhaled administration of the aerosol of the medically active liquid, the inhalation device comprising:

[0015] a housing; a reservoir within the housing for storing the medically active liquid; a pumping unit for generating pressure downstream of the reservoir, the pumping unit being connected to a mechanical energy delivery device that delivers mechanical energy to the pumping unit; and a nozzle downstream of the pumping unit;

[0016] wherein the pumping unit comprises a hollow cylindrical part and a piston, the cylindrical part having an interior space configured to receive an end of the piston, wherein the cylindrical part and the piston are linearly movable relative to each other to form a pumping chamber having a variable volume;

[0017] The suction device further comprises a check valve, thereby allowing the liquid to flow in a downstream direction and preventing the liquid from flowing in an opposite direction, the check valve comprising a movable valve body and a valve seat arranged upstream of the movable valve body, the valve seat being arranged at a downstream opening of a hollow valve seat extension section having an upstream opening, and

[0018] The valve body of the check valve includes a protrusion on a side facing the valve seat, the protrusion extending through the valve seat and passing through the opening of the valve seat extension section, the size of the protrusion being set to leave a gap between its side surface and the inner side of the hollow valve seat extension section, wherein further, the upstream end of the protrusion is configured to mechanically interact with the upstream end of the hollow valve seat extension section, thereby being prevented from entering the hollow valve seat extension section, thereby limiting the movement of the valve body in the downstream direction.

[0019] In a second aspect, the present invention provides the use of an inhalation device according to the first aspect of the invention for treating or preventing a respiratory disorder by inhaled administration of an aerosol of a medicinally active liquid.

[0020] In a third aspect, the present invention provides a use of an inhalation device according to the first aspect of the present invention for preventing or treating a respiratory disorder.

[0021] In a fourth aspect, the invention relates to a method of treating a subject suffering from a lung disease or condition, the method comprising the step of administering to the subject a pharmaceutical composition in nebulised (aerosolised) form using an inhalation device according to the first aspect of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 A medically active liquid nebulizer is schematically shown before first use;

[0023] Figure 2 shows the initial filling of the pumping chamber before Figure 1 implementation plan;

[0024] Figure 3 The situation during the first activation is shown;

[0025] Figure 4 The situation at the end of the first activation is shown;

[0026] Figure 5 shows a schematic cross-sectional view of a valve known in the art;

[0027] Figure 6 A schematic cross-sectional view of a first embodiment of a check valve included in an inhalation device according to the present invention is shown;

[0028] Figure 7 A schematic cross-sectional view of a second embodiment of a check valve included in an inhalation device according to the present invention is shown;

[0029] Figure 8 A schematic cross-sectional view showing a third embodiment of a check valve included in an inhalation device according to the present invention;

[0030] Fig. 9 , Fig.10 An embodiment of the upstream end of the protrusion of the non-return valve comprised by the inhalation device according to the invention is shown. DETAILED DESCRIPTION

[0031] Introductory terms are given which are used in the specification and claims. These definitions should be used to determine the meaning of each expression unless the context requires a different meaning.

[0032] An "inhaler" or "inhalation device" is a device configured and adapted to produce an inhalable mist, vapor or spray.

[0033] "Nebulization" and "atomization" in inhalers refer to the production of fine, inhalable droplets. The typical size of atomized droplets is in the range of a few micrometers.

[0034] An "aerosol" is a dispersion of a solid or liquid phase in a gas phase. The dispersed phase, also known as a discontinuous phase, is composed of a plurality of solid or liquid particles. The aerosol produced by the inhalation device of the present invention is a dispersion of a liquid phase in the form of inhalable droplets in a gas phase, usually air. The dispersed liquid phase may optionally include solid particles dispersed in the liquid.

[0035] A "liquid" is a fluid material that is able to change its shape with the shape of the container in which it is contained, but maintains a nearly constant volume independent of pressure. Liquid can refer to a single-phase liquid solution or a dispersion having a continuous liquid phase and a dispersed phase, which may or may not be a liquid.

[0036] "Plurality" means two or more.

[0037] As used herein, the term "comprising" and related terms "including" or "comprising" should be understood to mean that in addition to the features listed after the term, other features may be present. Conversely, the term "consisting of" and related terms will be understood to mean that in addition to those features listed after the term, other features are not present, and if present, they are present only in trace or residual amounts, so as not to confer technical advantage or relevance with respect to the purposes of the present invention.

[0038] "Inner" means inside, but is also designated as facing inward; "outer" means outside, but is also designated as facing outward.

[0039] A "nozzle" is a device for atomizing / spraying a liquid. Usually, the term refers to the entire unit. However, a nozzle may include one or more groups of separate, identical or different subunits. A nozzle may have multiple spray channels for discharging one or more liquids.

[0040] The "principal axis" of a nozzle is its central axis which is parallel to or co-linear with the direction in which the majority of the emitted aerosol exits the nozzle.

[0041] A "horizontal" plane is a plane perpendicular to the main axis.

[0042] As used herein, the term "upstream" refers to a direction towards the reservoir.

[0043] As used herein, the term "downstream" refers to a direction towards the nozzle.

[0044] Further definitions are provided in the description that follows.

[0045] In a first aspect, the underlying object of the present invention is solved by an inhalation device for generating an aerosol of a medically active liquid and for inhaled administration of the aerosol of the medically active liquid, the inhalation device comprising:

[0046] a housing; a reservoir within the housing for storing the medically active liquid; a pumping unit for generating pressure downstream of the reservoir, the pumping unit being connected to a mechanical energy delivery device that delivers mechanical energy to the pumping unit; and a nozzle downstream of the pumping unit;

[0047] wherein the pumping unit comprises a hollow cylindrical part and a piston, the cylindrical part having an interior space configured to receive an end of the piston, wherein the cylindrical part and the piston are linearly movable relative to each other to form a pumping chamber having a variable volume;

[0048] The suction device further comprises a check valve, thereby allowing liquid to flow in a downstream direction and preventing liquid from flowing in an opposite direction, the check valve comprising a movable valve body and a valve seat arranged upstream of the movable valve body, the valve seat being arranged at and fluidly connected to a downstream opening of a hollow (e.g., bore-like) valve seat extension section, the hollow valve seat extension section also having an upstream opening, and wherein

[0049] The valve body of the check valve includes a protrusion on a side facing the valve seat, the protrusion extending through the valve seat and passing through the upstream opening of the valve seat extension section, the size of the protrusion being set to leave a gap between its side surface and the inner side of the hollow valve seat extension section, wherein further, the upstream end of the protrusion is configured to mechanically interact with the upstream end or upstream end region of the hollow valve seat extension section, thereby being prevented from entering the hollow valve seat extension section, thereby limiting the movement of the valve body in the downstream direction.

[0050] With regard to the feature of the relative movement of the hollow cylindrical part and the piston of the pumping unit, this can preferably be achieved by attaching the cylindrical part to the housing of the present inhalation device and the piston being movable therein, or by attaching the piston to the housing and the cylindrical part being movable therein, or both parts being movable relative to the housing and to each other. For further explanation, reference is made to the following description and the accompanying drawings.

[0051] This object is further solved by other aspects of the invention which are described further below. Advantageous embodiments are described in the respective dependent claims, the following description and the drawings.

[0052] The inhalation device according to the present invention is intended to be used to generate an aerosol from a medically active liquid for inhalation therapy. In particular, the inhalation device is adapted to generate and discharge an atomized aerosol for pulmonary delivery of a pharmaceutically active ingredient in a dosed manner. The inhalation device according to the present invention comprises a valve, or more specifically, a check valve as described in further detail below.

[0053] Usually, this suction device comprises housing, and in housing, there is the reservoir for storing liquid (for example medical active liquid).Reservoir can have the capacity of storing about 1mL to about 100mL liquid volume, preferably about 2mL to about 50mL, particularly preferably about 4mL to about 10mL, for example about 4.5mL.Downstream of reservoir, described device comprises preferably the pumping unit based on piston pump or plunger pump principle and the nozzle in described pumping unit downstream.Obviously, pumping unit is connected to nozzle and reservoir fluidly.

[0054] The pumping unit of the inhalation device is used to generate pressure and is connected to or driven by a mechanical energy delivery device that delivers mechanical energy to the pumping unit. By means of the device, a predetermined, relatively constant peak value of mechanical energy can be supplied to the pumping unit, which is sufficient to generate the required discharge pressure. Therefore, the discharge or delivery performance of the device has excellent reproducibility compared to devices in which the discharge pressure is manually provided by the user and therefore the discharge pressure varies greatly during the discharge phase.

[0055] More specifically, the pumping unit comprises a hollow cylindrical part having an interior space. Note that the term "cylindrical part" refers to a part having a cylindrical inner surface; the exterior and interior that are not in contact with components that can move relative to the cylindrical part do not have to be cylindrical.

[0056] The pumping unit of this suction device further comprises a piston. The inner space of the cylindrical part as described above has a limited cross section, and usually its diameter is in the scope of about 0.5mm to about 10.0mm, preferably in the scope of about 1mm to about 3mm, and particularly preferably in the scope of about 1.5mm to about 2.5mm, and is configured to receive the end of the piston. The cross section of the piston is preferably basically matched with the cross section of the inner space. One or more seals or gaskets can be present to minimize the loss of the little but inevitable space between the inner space of the piston and the cylindrical part with the pressure. If there are such parts, then preferably the cross section is designed accordingly.

[0057] Further, the cylindrical part and the piston of the pumping unit can move linearly relative to each other, thereby forming a pumping chamber with variable volume according to the position of the piston in the cylindrical part. Therefore, by changing the volume, the pressure in the pumping chamber also changes accordingly. Both situations are possible, i.e., immovable cylindrical part and movable piston, and movable cylindrical part and immovable piston. However, in a preferred embodiment of this inhalation device, the pumping unit comprises an immovable or fixed piston and a movable cylindrical part.

[0058] The inhalation device of the present invention further comprises a valve, or more specifically a check valve, which can be fluidly arranged between the reservoir and the pumping unit and / or between the pumping unit and the nozzle, thereby allowing the liquid to flow in the downstream direction and preventing the liquid from flowing in the opposite direction. In other words, the check valve is used to establish the desired flow direction of the liquid from the reservoir to the nozzle (i.e., the downstream direction).

[0059] The check valve comprises a movable valve body and a valve seat arranged upstream of the valve body. The valve seat is arranged at a downstream opening of a hollow valve seat extension section, which also has an upstream opening. The medically active liquid must be able to flow into the upstream opening of the hollow valve seat extension section, pass through the hollow valve seat extension section, and leave the hollow valve seat extension section from its downstream opening into the valve seat. The downstream opening can also be described as forming an upstream opening of the valve seat, because they are fluidly connected to each other.

[0060] According to the invention, in contrast to known valves and pumping chambers, in particular for inhalation devices with a pumping unit with a fixed piston, the valve body of the non-return valve comprises a protrusion on its side facing the valve seat, which extends through the valve seat towards the reservoir and through the downstream opening of a "hollow valve seat extension section" arranged upstream, which has a corresponding upstream opening. This means that the area forming the actual valve seat is preceded by a hollow section, the walls of which are preferably formed of solid material, for example, of the same material from which the valve seat is formed. In a further preferred embodiment, the hollow section, or more specifically the walls of the hollow section and the valve seat are formed integrally, or in other words, as an integral unit.

[0061] Further, the size of the protrusion is set to leave a gap between its side surface and the inner side of the valve seat extension section. This means that due to the existence of the gap, liquid can flow through the extension section because the protrusion is correspondingly thinner than the width of the opening.

[0062] Finally, the upstream end of the protrusion is configured to physically or mechanically interact with the upstream end or upstream end region or surface of the hollow valve seat extension section, thereby being prevented from entering the hollow valve seat extension section, thereby limiting the movement of the valve body in the downstream direction, wherein "mechanically" refers to all types of interactions that lead to the desired restriction, regardless of whether there is actual physical surface contact. For example, as described in further detail below, in this regard, magnetic forces can also be suitable for providing such physical or mechanical interaction. This means that the valve body cannot move any distance away from its closed position when it is in contact with the valve seat. In fact, its movement, more precisely, the maximum distance between the valve body and the valve seat, is generally defined as a maximum distance in the range of from about 0.01 mm to about 5 mm, preferably from about 0.1 mm to about 2 mm, and particularly preferably from about 0.5 mm to about 1.5 mm.

[0063] Contrary to known technical solutions, this movement is not limited by the known "cage" structure (i.e., components or features arranged downstream of the working area), but according to the present invention, it is limited by components or features arranged upstream of the working area. Further, in order to implement the non-return valve of the inhalation device of the present invention described, it is not necessary to modify the working area of ​​the valve, but only the valve body, because the protrusion is a feature that is an integral part of the valve body. By controlling the length of the protrusion, the range of motion of the valve body can be adjusted, and the dead volume can be adjusted, for example, as small as possible.

[0064] Although the protrusion extends through the hollow seat extension area and the valve seat, resulting in a possible slight increase in fluid resistance through the valve, it will be appreciated that the valve body and protrusion will not (completely) prevent or interrupt liquid flow in the downstream direction.

[0065] Therefore, due to the easy to achieve sufficiently accurate manufacture of the valve body with projection using available manufacturing technology, the check valve provides a precisely controllable, stable working area size without the need to modify the area. Therefore, the dead volume can be easily minimized, which is particularly important when used in an inhalation device for administering medically active liquids as in the present invention. In addition, no additional working steps are required to manufacture or assemble the improved check valve, because the valve body is simply inserted into the valve seat, automatically establishing a mechanical interaction in the valve seat, which will be further described below.

[0066] Another advantage of the non-return valve as described above in the context of the inhalation device of the invention is that the presence of the protrusion acts as a means of guiding the valve body by allowing the protrusion to slide along the inner wall of the hollow valve seat extension section. Since the valve body is connected to the protrusion, the risk of the valve body tilting is reduced compared to a valve body that floats freely against a mechanical stop. In the known art, a valve body that provides sufficient security against tilting must have a cross-section that is almost as large as the space around it in order to be guided; however, if the remaining clearance to said space is too small, i.e. only one tenth or one hundredth of a micrometer, the flow resistance becomes undesirably high.

[0067] According to a specific embodiment, the check valve as described above is fluidly arranged between the reservoir and the pumping unit. In this way, the valve prevents the liquid from flowing back into the reservoir from the pumping chamber; especially in the high pressure stage. If there is no such valve, part of the liquid present in the pumping chamber will be lost during the actual suction process, which is obviously undesirable. In particular, in the case where the pumping unit of the suction device of the present invention includes an immovable or fixed piston and a movable cylindrical part as described above, the check valve included in the present suction device may be particularly advantageous: because all parts of the check valve that limit the movement of the valve body, such as the protrusion of the valve body or the valve seat extension section are located upstream of the valve body, when used as an inlet check valve, the dead zone between the valve and the movable pumping chamber can be minimized or completely eliminated.

[0068] In a further specific embodiment, which may be combined with the preceding embodiments, a check valve may be fluidly arranged between the pumping unit and the nozzle. In this embodiment, the check valve serves to avoid a backflow of liquid or ambient air from the nozzle into the pumping chamber when a refilling phase occurs, which is characterized by a negative pressure within the pumping chamber. Without the valve, the negative pressure provided by the pump would not only result in refilling the chamber with fresh liquid from the reservoir, but also with unwanted air or droplets escaping from the nozzle outlet, reducing the efficiency of the refilling process and resulting in possible contamination of the interior of the volume upstream of the nozzle.

[0069] According to a further embodiment, the upstream end of the projection of the non-return valve included in the inhalation device of the present invention comprises at least one flexible structure (e.g., a hook-like structure), which is configured to be elastically deformable so that when in a deformed state, it fits in the hollow valve seat extension section and is arranged to be permanently unfolded when passing through the hollow valve seat extension section so that the upstream end extends laterally beyond the width of the upstream opening of the hollow valve seat extension section. In other words, when the valve is assembled, i.e., by pushing the projection through the valve seat and the hollow valve seat extension section thereafter, the end of the projection can be temporarily folded or compressed so as to be inserted into the hollow valve seat extension section. When the valve body is sufficiently close to its valve seat, the structure will automatically unfold due to the length dimension of the projection being set accordingly, because it has now passed through the area of ​​limited width (the hollow valve seat extension area) and is now located in front of the upstream opening of the hollow valve seat extension section, i.e., upstream, where sufficient space is available. However, once the unfolding is completed, according to these embodiments of the present invention, the structure can no longer slide back into the upstream opening without applying excessive forces that are not present during normal use. The structure remains in the deployed state unless excessive forces are applied, which are not expected during normal use.

[0070] The shape and material of the end of the projection may be such that it is permanently deformed (damaged) even when pulled back through the opening. It may also be configured so that it is not permanently deformed; thus, it is possible to repair the valve and then reassemble its parts. In this way, if necessary, the valve body may be replaced without the risk of damaging the valve seat and / or the valve seat extension area during disassembly.

[0071] In another embodiment, a ring-like or rod-like structure can be attached to the upstream end of the check valve protrusion, which increases the overall lateral dimension of the upstream end so that it is greater than the width of the opening. After the protrusion has been guided through the hollow valve seat extension section, the structure as an additional component can be firmly connected to the end. In this way, the design of the upstream end including the additional component allows, on the one hand, a greater difference in the size (e.g. diameter) of the hollow valve seat extension section, and on the other hand, a greater difference in the size of the components, because during assembly, the components must not fit within the hollow valve seat extension section. Therefore, it can also be made of a rigid, inflexible material and / or have such dimensions that, despite any possible flexibility, it will not fit within the hollow valve seat extension section.

[0072] In yet another embodiment, the upstream end of the protrusion of the check valve can be configured to provide a magnetic force that counteracts a magnetic force of corresponding magnitude arranged inside the hollow valve seat extension section and / or at the upstream end of the hollow valve seat extension section, such that a balance of the magnetic forces limits the movement of the valve body. In other words, it is not the force generated by the mechanical contact of the different components, but the magnetic force that prevents the valve body from passing the desired maximum position, which allows a sufficiently small fluid resistance during the low-pressure stage while providing the smallest possible dead volume when switching to the high-pressure stage. For the avoidance of doubt, in the context of the present invention, such a magnetic force as described above will be understood as a mechanical interaction.

[0073] If necessary, the magnetic force can be easily adjusted so that the valve opens only after a minimum (positive) pressure threshold is exceeded, i.e. there is a sufficiently high pressure difference between the reservoir and the pumping chamber, or between the pumping chamber and the nozzle, respectively. Thus, during storage of the inhalation device, the valve can be permanently closed; while the force required to open the valve during refilling of the pressure chamber is very small (but not zero), only little additional energy (pressure loss) is required to open the pressure chamber. This may also be the case when the valve is arranged before the nozzle; it can be opened already at the very beginning of the high pressure phase, but the conduit can be kept closed during storage.

[0074] The protrusion may then be, for example, rod-shaped, so that any increase in the size of its upstream end is obsolete, since even the rod-shaped part itself may be designed to provide said magnetic force.

[0075] In other embodiments, the described threshold feature can be achieved by a resilient element, such as a tension or compression spring, more specifically, a coil spring or an elastic polymer element, such as a rubber element, or a pressurized hydraulic or pneumatic actuator, which is dimensioned accordingly and positioned between the upstream end of the hollow valve seat extension section and the upstream end of the protrusion.

[0076] In yet another embodiment, the elastic element may be arranged on the downstream side of the hollow valve seat extension section, pulling or pushing the valve body against the valve seat. The spring force provided by such an elastic element should be small relative to the drag force provided by the liquid when the liquid flows in the opposite direction to the spring force, for example, less than 20% of the drag force provided by the flowing liquid, preferably less than 10%, and particularly preferably less than 5%.

[0077] According to a further embodiment, the diameter of the valve body is about 1 mm ± 0.3 mm, and / or the length of the protrusion is about 0.5 mm ± 0.4 mm, and / or the width of the gap is between 50 μm and 1000 μm, preferably between 100 μm and 300 μm, and / or the upstream end laterally extends beyond the opening by at least about 0.5 mm. The diameter of the pumping chamber is preferably between about 0.5 mm and about 10 mm, and preferably between about 1 mm and about 3 mm. The length of the pumping chamber is preferably in the range of about 0.5 mm to about 50 mm, and preferably in the range of about 2 mm to about 25 mm, and particularly preferably in the range of about 5 mm to about 20 mm. The dead volume of the check valve is preferably below 500 μm. 3 , and preferably at about 0.001 μm 3 To about 100 μm 3 is selected within the range of about 0.01 μm, and is particularly preferably selected within the range of about 0.01 μm 3 To about 1μm 3 Select within the range.

[0078] In a specific embodiment, with respect to a single dose of a medically active liquid administered by the inhalation device according to the invention, the percentage of the non-return valve dead volume is less than 10% of the volume of the dose, preferably less than 2% of its volume, particularly preferably less than 1% of its volume.

[0079] In a further embodiment, the flow rate of the medically active liquid through the open valve is selected in the range of about 1 μl / sec to about 100 μl / sec. In a further embodiment, the check valve comprised by the inhalation device of the present invention, or more specifically, the dynamic characteristics of the check valve, allows for an opening and closing time of up to 100 msec, for example from about 1 msec to about 50 msec.

[0080] As mentioned above, suction device according to the present invention comprises housing, and the shape and size of said housing are preferably arranged to make and can be held with one hand and can operate with a finger (for example thumb).Correspondingly, in a specific embodiment, suction device according to the present invention or inhaler can be a handheld device.Described suction device comprises the reservoir that is used to store medical active liquid, and as described in further detail below, described reservoir can be positioned at housing interior.

[0081] Suction devices according to the present invention may include a collapsible reservoir. In a specific embodiment, the reservoir may have elastic or at least soft walls that may bend when emptying so that the necessary negative pressure for extracting a certain amount of medically active liquid does not increase or hardly increases. In an alternative embodiment, the reservoir may be a rigid container with a removable bottom through which the internal volume of the reservoir may also be continuously reduced.

[0082] Further, as described above, the inhalation device may include a pumping unit located within the housing, the pumping unit having a pumping chamber for generating a desired pressure, the pressure being necessary for discharging the medically active liquid and atomizing the medically active liquid. The pumping unit may also include additional components, such as buttons, locking devices, etc.

[0083] The pumping unit may comprise a hollow piston and a cylindrical part adapted to receive at least one end of the piston, preferably a fixed piston as described above, wherein the cylindrical part and the piston are linearly movable relative to each other to form the aforementioned pumping chamber with variable volume.

[0084] As described above, the pumping chamber may be fluidly connected to the reservoir via an inlet check valve as described in detail above. The check valve may be used to allow the medically active liquid to flow into the pumping chamber and may prevent the medically active liquid from flowing back into the reservoir when the locking mechanism is released. There may also be an outlet check valve to prevent liquid or ambient air from flowing back into the pumping unit through the nozzle.

[0085] Downstream of the pumping unit, at least one nozzle may preferably be arranged for atomizing the liquid pressurized by the pumping unit. Preferably, the nozzle is of the impact type, having at least two jet channels, which are arranged to eject at least two jets of the medically active liquid as described below along respective jet trajectories, which intersect each other at a collision point.

[0086] In a specific embodiment, the inhalation device for inhalation administration of aerosols of pharmaceutically active liquids according to this aspect of the invention comprises a pharmaceutically active liquid in the form of a pharmaceutical composition comprising at least one active pharmaceutical ingredient (API), more specifically at least one inhalable active pharmaceutical ingredient, which inhalable active pharmaceutical ingredient may preferably be selected from long-acting muscarinic antagonists (LAMAs), long-acting beta agonists (LABAs) and inhaled glucocorticoids (ICSs), as well as analgesics and antidiabetics, alone or in combination with each other.

[0087] Examples of long-acting muscarinic antagonists (LAMAs) include, but are not limited to, aclidinium bromide, glycopyrrolate salts such as glycopyrrolate, revenacin, troponium bromides such as tiotropium, umeclidinium, oxitropium, flutropium, ipratropium, trospium chloride, tolterodine.

[0088] Examples of long-acting beta agonists (LABAs) include, but are not limited to, albuterol, aformoterol, bambuterol, bitolterol, brosaterol, carbuterol, clenbuterol, fenoterol, formoterol, hexadrenaline, ibuterol, indacaterol, isetaline, isoproterenol, levalbuterol, mabuterol, isobutyl acetate, metaproterenol, olodaterol, metaproterenol, pirbuterol, procaterol, reproterol, rimaterol, ritodrine, salmeterol, samethamine, sotenot, sulphonterol, tiaramde, terbutaline, terbuterol.

[0089] Examples of inhaled corticosteroids (ICS) include, but are not limited to, prednisolone, prednisone, butixocortpropionate, flunisolide, beclomethasone, triamcinolone acetonide, budesonide, fluticasone, mometasone, ciclesonide, roflenide, dexamethasone, eprednolate, deflazacort, etiprednol, loteprednol, RPR-106541, NS-126, ST-26.

[0090] Furthermore, the active pharmaceutical ingredient may be selected from: analgesics, such as opioid analgesics (eg fentanyl) or non-opioid analgesics (salicylic acid derivatives, such as acetylsalicylic acid); antidiabetic drugs, such as insulin.

[0091] The medically active liquid or liquid drug composition that is nebulized or aerosolized by the present inhalation device may include at least one active pharmaceutical ingredient as described above, but may also include a mixture of two or more active pharmaceutical ingredients that can be administered by inhalation.

[0092] The medically active liquid or pharmaceutical composition administered by the inhalation device according to the invention is preferably formulated as a composition suitable and adapted for use with inhalation, in other words a composition which can be nebulized or atomized for inhalation and which is physiologically acceptable for inhalation by a subject.

[0093] The medically active liquid or pharmaceutical composition administered by the inhalation device of the invention or contained in the inhalation device and reservoir may be in the form of a dispersion, such as a suspension having a liquid continuous phase and a solid dispersed phase, or in the form of a solution.

[0094] In further embodiments, the medically active liquid or pharmaceutical composition may optionally include one or more physiologically acceptable excipients suitable for use by inhalation. Excipients that may be characterized in the composition may include, but are not limited to, one or more buffers that adjust or control the pH of the solution, salts, taste masking agents, surfactants, lipids, antioxidants, and cosolvents that can be used to increase or improve solubility, such as ethanol or ethylene glycol.

[0095] In a particular embodiment, the liquid composition administered by the inhalation device of the invention is substantially free of propellant.

[0096] In a further specific embodiment, the medically active liquid or liquid composition can be an aqueous solution, wherein one or more active pharmaceutical ingredients as described above are dissolved or solubilized in a liquid carrier solution comprising water. This aqueous solution may optionally also contain one or more excipients as described above.

[0097] It should be noted that all embodiments, features and combinations thereof described above in relation to the inhalation device of the first aspect of the present invention are correspondingly applicable to the other aspects of the present invention.

[0098] In a second aspect, the present invention relates to the use of an inhalation device according to the first aspect of the invention as described above for treating or preventing a respiratory disease, disorder or condition by inhalation administration of an aerosol of a medically active liquid as described above. In particular, an inhalation device according to the present invention may be used to treat or prevent a pulmonary disease or condition. As understood herein, a pulmonary disease, disorder or condition may affect one or more anatomical aspects and / or functions of the lungs and associated respiratory airways of a subject.

[0099] The term "treatment" as used herein refers to the administration of a medically active liquid or pharmaceutical composition for the treatment of a lung disease, disorder, or condition, such as to improve, reduce, or alleviate at least one symptom of the disease or condition, or to stop or slow the development of at least one symptom of the disease, disorder, or condition, such as to maintain lung function. The term "prevention" as used herein, such as a lung disease or condition, can be understood as prophylactic treatment, and refers to the administration of a medically active liquid or pharmaceutical composition to a subject who may not have developed such a disease (e.g., a lung disease, disorder, or condition) but is at risk or susceptible to the disease, disorder, or condition.

[0100] In both the treatment and prevention of respiratory disorders or pulmonary diseases, disorders or conditions, the medically active liquids or pharmaceutical compositions may be administered in therapeutically effective amounts via the inhalation devices and embodiments described herein.

[0101] In a particular embodiment, the respiratory disorder may be a pulmonary disease, disorder or condition, such as asthma and / or chronic obstructive pulmonary disease (COPD), in particular COPD. In a further particular embodiment, the pulmonary disease, disorder or condition may be an interstitial lung disease affecting the interstitium of the lungs and lung tissue, such as an interstitial lung disease associated with the airways and / or air sacs (alveoli), such as pulmonary fibrosis, interstitial pneumonia or sarcoidosis.

[0102] In a third aspect, the present invention provides the use of an inhalation device according to the first aspect of the invention as described above, for treating or preventing a respiratory disease, disorder or condition by inhaled administration of an aerosol of a medically active liquid or pharmaceutical composition as described above.

[0103] In particular embodiments of this aspect of the invention, the respiratory disease, disorder or condition may be a pulmonary disease, disorder or condition, in particular asthma and / or chronic obstructive pulmonary disease (COPD), or an interstitial lung disease, such as pulmonary fibrosis, in particular idiopathic pulmonary fibrosis (IPF).

[0104] In a further aspect, the present invention also relates to the use of an inhalation device according to the second aspect of the invention for preventing or treating a respiratory disease, disorder or condition as described above.

[0105] In a fourth aspect, the present invention provides a method for treating a subject, particularly a human subject or patient, suffering from a respiratory disease, disorder or condition, or preventing a subject from suffering from such a respiratory disease, disorder or condition, such as a lung disease, disorder or condition, particularly asthma and / or chronic obstructive pulmonary disease (COPD), or in a further embodiment, an interstitial lung disease, such as pulmonary fibrosis, in particular idiopathic pulmonary fibrosis (IPF), the method comprising the step of administering to the subject a medically active liquid or pharmaceutical composition in nebulized (aerosolized) form using an inhalation device according to the first aspect of the invention.

[0106] In a particular embodiment, the inhalation device of the first aspect of the invention for use in the method of this aspect of the invention is a handheld, i.e. portable, device, whereby administration of the medically active liquid or pharmaceutical composition and actuation of the device is performed by the human subject or patient himself directly and in accordance with prescription instructions attached to the device.

[0107] Detailed Description of the Drawings

[0108] exist Figures 1 to 4 In the figure, an exemplary inhalation device for medically active liquids is depicted schematically and not to scale, as is known from international patent application WO 2018 / 197730 A1. Figure 1 The situation before first use is shown.

[0109] The inhalation device comprises a housing 1, the shape and size of which are preferably arranged so that it can be held with one hand and can be operated with one finger, such as a thumb (not shown). A reservoir 2 for storing a medically active liquid L is located inside the housing 1. The depicted reservoir 2 is designed to be collapsible; this means that when emptying, the elastic or at least soft walls bend so that the negative pressure necessary for extracting a certain amount of liquid L does not increase or hardly increases. A similar effect can be obtained when the rigid container has a removable bottom, by which the internal volume (not shown) of the reservoir 2 can also be continuously reduced.

[0110] Further, the inhalation device comprises a pumping unit 3 having a pumping chamber 3D in the housing 1 for generating a desired pressure necessary for discharging and atomizing the liquid L. The pumping unit 3 may also comprise other components (buttons, locking devices, etc.) not depicted.

[0111] The pumping unit 3 comprises a hollow cylindrical part 3A having an inner space 3C configured to receive an end 3B' of the piston 3B, wherein the cylindrical part 3A and the piston 3B are linearly movable relative to each other, thereby forming a pumping chamber 3D with a variable volume.

[0112] The pumping chamber 3D is fluidly connected to the reservoir 2 via an inlet check valve 4. The check valve 4 is used to allow the liquid L to flow into the pumping chamber 3D and to prevent the liquid L from flowing back into the reservoir 2 when a locking mechanism, not shown, is released.

[0113] In other words, the piston 3B can be at least partially pushed into the hollow cylindrical part 3A, causing the internal volume of the pumping chamber 3D to decrease. The term "internal volume" describes the volume extending from the inlet of the pumping chamber 3D facing the reservoir, where the valve 4 is arranged, to the location of the upstream end of the piston 3B, where the additional outlet valve 7 is located. Figure 1 In the depicted situation, the piston 3B is almost completely housed in the hollow cylindrical part 3 A. As a result, the internal volume of the pumping chamber 3D between the non-return valve 4 and the upstream end of the piston 3B is at a minimum.

[0114] As the potential energy storage device 6, there is provided a spring, one end of which is coupled (upward) to the hollow cylindrical part 3A, and which is supported on the housing 1 (lower part of the figure).

[0115] Preferably, in the area for receiving the piston 3B, the pumping chamber 3D has a circular inner cross section, which corresponds to the (then also) circular outer cross section of the corresponding piston part. Of course, other cross-sectional shapes are also possible.

[0116] According to the depicted embodiment, a non-return valve 4 is arranged between the reservoir 2 and the inlet of the pumping chamber 3D.

[0117] An optional outlet valve 7 inside the piston 3B is also depicted, which is used to avoid a backflow of liquid L or air from the outside to the outer end of the piston 3B. The outlet valve 7 is arranged in the inner end of the piston 3B. The liquid L can pass through the outlet valve 7 in the direction of the nozzle 5, but the outlet valve 7 prevents any undesired backflow in the opposite direction.

[0118] Finally, the suction device comprises a nozzle 5, which is fluid-tightly connected to the outer downstream end of the piston 3B. The nozzle 5 can be any known nozzle suitable for atomizing\atomizing liquid. The nozzle 5 described as an example has used the atomization principle by means of two colliding liquid jets. Preferably, the cross section accommodating the liquid passage is relatively small, and is usually within the range of microns.

[0119] from Figure 1 As can be seen in the figure, in the depicted example, the piston 3B is designed to be immovable and firmly attached to the housing 1, as indicated by the connection with the housing 1 in its outer end region. The piston 3B is also firmly attached to the nozzle 5, which in turn is attached to the housing 1. Conversely, the hollow cylindrical part 3A is designed to be movable relative to the housing 1 and the nozzle 5. Note that the invention can also be used in the case of a fixed hollow cylindrical part 3A and a movable piston 3B.

[0120] Figure 2 shows when the pumping chamber 3D is initially filled Figure 1 , in which some already introduced reference numerals are omitted. The hollow cylindrical part 3A is pulled down, loading the potential energy storage device 6. The outlet valve 7 is closed due to the negative pressure in the pumping chamber 3D, and the check valve 4 is opened to the reservoir 2. In the following, this situation is also referred to as the "low-pressure phase". The gradual collapse of the wall of the reservoir 2 allows its internal pressure to remain almost constant, while the pressure inside the pumping chamber 3D drops, because the downward movement pulls the hollow cylindrical part 3A away from the piston 3B, increasing the internal volume of the pumping chamber 3D. As a result, the pumping chamber 3D is filled with liquid L from the reservoir 2.

[0121] exist Figure 3 , the situation during the first activation of the inhalation device is shown. Figure 2 As shown, the potential energy storage device 6 has been released from the loaded position. It pushes the hollow cylindrical part 3A comprising the pumping chamber 3D onto the piston 3B, the inner end of which is closer to the now closed non-return valve 4. As a result, the pressure in the pumping chamber 3D increases and keeps the inlet valve 4 in the closed position, but opens the outlet valve 7. The liquid L rises inside the piston 3B towards its outer end and the nozzle 5. This situation is also called the "high pressure phase".

[0122] Figure 4 The situation at the end of the first (or any subsequent) activation is shown. The potential energy storage device 6 is in its most relaxed end position (the spring is fully extended). In addition, the hollow cylindrical part 3A is almost completely pushed onto the piston 3B, so that the internal volume of the pumping chamber 3D reaches its minimum value. Most of the liquid L previously contained in the pumping chamber 3D has entered the piston 3B through the outlet valve 7. The liquid L already contained in the piston 3B has been pushed toward and through the nozzle 5, where the desired atomization occurs, producing a spray, or more specifically, an aerosol to be applied. This situation is also called the "discharge phase", which is also part of the aforementioned "high pressure phase".

[0123] like Figures 1 to 4 As shown, both check valves 4, 7 are designed as ball valves having a valve seat and a cage-like blocking structure to limit the movement of the ball in the downstream direction.

[0124] exist Figure 5 In the figure, a cross-sectional schematic diagram of a valve known in the field of suction devices is shown. For the sake of clarity, liquid is not shown in the figure. In this figure and the following figures, the desired flow direction points upward.

[0125] The valve 4 comprises a valve body 4A adapted to be mounted in a valve seat 4B. The valve body 4A is movable in the vertical direction. A ring 4H is fixedly inserted downstream of the valve body 4A so as to limit the movement of the latter. When the valve body 4A is in its most downstream position (not shown), the vertical distance between its upstream side and the valve seat 4B defines the aforementioned dead volume.

[0126] The valve body 4A is exemplarily shown as a cylinder with an upstream end in the shape of a truncated cone, and the valve seat 4B is correspondingly shaped as a funnel. However, the valve body 4A may also have a full or hemispherical shape, and the valve seat 4B may have a correspondingly shaped design. It should be noted that this also applies to the valve body and valve seat discussed in the following figures.

[0127] Figure 6 A schematic cross-sectional view of a first embodiment of a non-return valve comprised by an inhalation device according to the invention is shown.In addition to the features known in the prior art and already shown in the previous figures, a protrusion 4C is attached to the upstream side of the valve body 4A.

[0128] The projection 4C extends in the upstream direction toward the reservoir (not shown) through the valve seat 4B having an opening, and passes through the hollow valve seat extension section 4D arranged upstream, the hollow valve seat extension section having a downstream opening (no reference numeral) facing the valve seat 4B and fluidly connected thereto, and an upstream opening 4G of the upstream end of the hollow valve seat extension section 4D arranged in the opposite direction. The projection 4C is sized to leave a gap G between its side surface and the inner side of the hollow valve seat extension section 4D. Further, the upstream end 4E of the projection 4C is configured to mechanically interact with the upstream end 4F of the hollow valve seat extension section 4D, thereby being prevented from (re)entering the latter when pulled or pushed in the downstream direction, thereby limiting the movement of the valve body 4A in the said direction.

[0129] In the depicted embodiment, the upstream end 4E of the protrusion 4C comprises a flexible hook-like structure, which is configured to be elastically deformable so as to fit within the hollow valve seat extension section 4D in a deformed state (not shown), since in the deployed state it is only slightly wider than the width of the upstream opening 4G and the internal space behind the hollow valve seat extension section 4D. As shown in the figure, the structure is arranged to assume the deployed state when passing through the hollow valve seat extension section 4D, more precisely, passing through its upstream end 4F. As a result, the upstream end 4E of the protrusion 4C extends transversely beyond the width of the upstream opening 4G of the hollow valve seat extension section 4D, and the movement of the valve body 4A in the downstream direction is restricted.

[0130] exist Figure 7 , a schematic cross-sectional view of a second embodiment of a non-return valve 4 included in an inhalation device according to the present invention is depicted. In this embodiment, the upstream end 4E of the protrusion 4C receives a detachable annular structure 4I, which increases the overall lateral dimension of the upstream end 4E so that it is larger than the width of the upstream opening 4G. As a result, when the annular structure 4I contacts the upstream end 4F of the hollow valve seat extension section 4D, the movement of the protrusion 4C is blocked, and therefore, the valve body 4A is blocked from moving further away from the valve seat 4B.

[0131] exist Figure 8, another embodiment of the check valve 4 included in the inhalation device of the present invention is schematically depicted. In this embodiment, the upstream end 4E of the protrusion 4C is configured to provide a magnetic force originating from the first magnet 4J, which offsets the magnetic force of the corresponding magnitude arranged inside the hollow valve seat extension section 4D and located at its upstream end 4F, so that the balance of the magnetic force limits the movement of the valve body 4A. In the figure, the black rectangle represents the "north pole" of the magnet and the white rectangle represents the "south pole". In order to avoid doubt, it should be mentioned that the opposite "magnetic pole" arrangement will produce the same desired effect. It can also be seen from the figure that the protrusion 4C can be pulled through the hollow valve seat extension section 4D without damaging any surface; however, during normal use, the resistance of the flowing liquid (not shown) to the movable part must always be lower than the force required to overcome the holding force provided by the magnets 4J and 4K.

[0132] One of the advantages of this embodiment is the possibility of repairing or replacing the valve body 4A.

[0133] Fig. 9 and Fig.10 FIG. 4 shows another embodiment of the upstream end 4E of the protrusion 4C of the check valve included in the present invention. The end 4E of the protrusion 4C is formed by a structure composed of beams arranged along the edges of a two-dimensional or three-dimensional rhombus, and the structure can be deformed perpendicular to the longitudinal direction of the protrusion 4C ( Fig.10 ). The angles, stiffness, etc. of the structure can be selected to withstand deformations that are too strong during normal use, so that mechanical interaction is always provided. However, when the valve body is pulled strongly, for example for maintenance (not shown), the diamond-shaped structure deforms so that the protrusion 4C can be pulled through the hollow seat extension area (not shown). In addition, reinsertion is possible. When in the undeformed state, the structure has a lateral dimension that provides the desired mechanical interaction with the upstream end 4F of the seat extension section 4D (not shown).

[0134] List of reference numerals:

[0135] 1 Shell

[0136] 2 Storage

[0137] 3 Pumping unit

[0138] 3A Hollow cylindrical parts

[0139] 3B Piston

[0140] 3B' (piston) end

[0141] 3C Interior Space

[0142] 3D pumping chamber

[0143] 4 valves, inlet valve

[0144] 4A valve body

[0145] 4B valve seat

[0146] 4C protrusion

[0147] 4D valve seat extension section

[0148] 4E (protruding) upstream end

[0149] 4F Upstream end (of valve seat extension)

[0150] 4G Upstream opening (of valve seat extension)

[0151] 4H Ring

[0152] 4I ring structure

[0153] 4JJ First Magnet

[0154] 4K Second Magnet

[0155] 5 Nozzles

[0156] 6 Mechanical Energy Delivery Devices

[0157] 7 Check valve, outlet valve

[0158] Liquid

[0159] G Clearance

[0160] The following is a list of numbered embodiments E1 to E14 encompassed by the present invention:

[0161] E1. A valve (4) for an inhalation device for generating an aerosol of a medically active liquid, the inhalation device comprising:

[0162] A housing (1); a reservoir (2) for storing the medically active liquid (L) within the housing (1); a pumping unit (3) for generating pressure downstream of the reservoir (2), the pumping unit being connected to a mechanical energy delivery device (6) for delivering mechanical energy to the pumping unit (3); and a nozzle (5) downstream of the pumping unit (3);

[0163] wherein the pumping unit (3) comprises a hollow cylindrical part (3A) and a piston (3B), the cylindrical part (3A) having an inner space (3C) configured to receive an end (3B') of the piston (3B), wherein the cylindrical part (3A) and the piston (3B) are linearly movable relative to each other to form a pumping chamber (3D) with a variable volume;

[0164] The suction device further comprises a check valve (4) to allow the liquid (L) to flow in a downstream direction and prevent the liquid (L) from flowing in an opposite direction, the check valve (4) comprising a movable valve body (4A) and a valve seat (4B) arranged upstream of the movable valve body (4A), the valve seat (4B) being arranged at a downstream opening of a hollow valve seat extension section (4D) having an upstream opening (4G), and wherein

[0165] The valve body (4A) of the check valve includes a protrusion (4C) on the side facing the valve seat (4B), and the protrusion (4C) extends through the valve seat (4B) and passes through the upstream opening (4G) of the valve seat extension section (4D), and the size of the protrusion (4C) is set to leave a gap (G) between its side surface and the inner side of the hollow valve seat extension section (4D), wherein further, the upstream end (4E) of the protrusion (4C) is configured to mechanically interact with the upstream end (4F) of the hollow valve seat extension section (4D), thereby being prevented from entering the hollow valve seat extension section (4D), thereby limiting the movement of the valve body (4A) in the downstream direction.

[0166] E2. Valve (4) according to embodiment E1, wherein the valve is fluidly arranged between the reservoir (2) and the pumping unit (3).

[0167] E3. The valve (4) according to embodiment E1, wherein the valve is fluidly arranged between the pumping unit (3) and the nozzle (5).

[0168] E4. A valve (4) according to any one of embodiments E1 to E3, wherein the upstream end (4E) of the protrusion (4C) includes at least one flexible structure, which is configured to be elastically deformable so as to fit within the hollow valve seat extension section (4D) in a deformed state, and is permanently expanded when arranged to pass through the hollow valve seat extension section (4D), so that the upstream end (4E) extends laterally beyond the width of the upstream opening (4G) of the hollow valve seat extension section (4D).

[0169] E5. A valve (4) according to any one of embodiments E1 to E3, wherein a ring-like or rod-like structure is attached to the upstream end (4E) of the protrusion (4C), which increases the overall lateral dimension of the upstream end (4E) so that it is larger than the width of the opening (4G).

[0170] E6. A valve (4) according to any one of embodiments E1 to E3, wherein the upstream end (4E) of the protrusion (4C) is configured to provide a magnetic force that offsets a magnetic force of a corresponding magnitude arranged inside the valve seat extension section (4D) and / or at its upstream end, so that the balance of the magnetic forces limits the movement of the valve body (4A).

[0171] E7. A valve (4) according to any of the preceding embodiments, wherein the diameter of the valve body (4A) is 1 mm ± 0.3 mm, and / or the length of the protrusion (4C) is 0.5 mm ± 0.4 mm, and / or the width of the gap (G) is between 50 μm and 1000 μm, and / or the upstream end (4E) laterally extends beyond the opening (4G) by at least 0.5 mm.

[0172] E8. An inhalation device for inhalation administration of an aerosol of a medically active liquid, comprising a valve according to any one of embodiments E1 to E7.

[0173] E9. An inhalation device according to embodiment E8, wherein the medically active liquid is a pharmaceutical composition comprising at least one inhaled active ingredient selected from a long-acting muscarinic antagonist (LAMA), a long-acting beta agonist (LABA) and an inhalable corticosteroid (ICS).

[0174] E10. Use of an inhalation device according to embodiment E8 or E9 for the treatment or prevention of respiratory disorders by inhaled administration of an aerosol of a medicinally active liquid.

[0175] E11. Use of an inhalation device according to embodiment E10, wherein the respiratory disorder is a lung disease or condition.

[0176] E12. Use of an inhalation device according to embodiment E10 or E11, wherein the pulmonary disease or disorder is asthma and / or chronic obstructive pulmonary disease (COPD).

[0177] E13. Use of an inhalation device according to any of embodiments E8 or E9 for the prevention or treatment of a respiratory disorder.

[0178] E14. A method for treating a subject suffering from a lung disease or condition, in particular asthma and / or chronic obstructive pulmonary disease (COPD), comprising the step of administering to the subject a pharmaceutical composition in nebulized (aerosolized) form using an inhalation device according to embodiments E8 to E10.

Claims

1. An inhalation device for generating an aerosol of a medically active liquid and for inhalation administration of the aerosol of the medically active liquid, the inhalation device comprising: A housing (1); a reservoir (2) in the housing (1) for storing the medically active liquid (L); a pumping unit (3) for generating pressure downstream of the reservoir (2), the pumping unit being connected to a mechanical energy delivery device (6) which delivers mechanical energy to the pumping unit (3); and a nozzle (5) downstream of the pumping unit (3); wherein the pumping unit (3) comprises a hollow cylindrical part (3A) and a piston (3B), the cylindrical part (3A) having an inner space (3C) configured to receive an end (3B') of the piston (3B), wherein the cylindrical part (3A) and the piston (3B) are linearly movable relative to each other to form a pumping chamber (3D) with a variable volume; The suction device further comprises a check valve (4) to allow the liquid (L) to flow in a downstream direction and prevent the liquid (L) from flowing in an opposite direction, the check valve (4) comprising a movable valve body (4A) and a valve seat (4B) arranged upstream of the movable valve body (4A), the valve seat (4B) being arranged at a downstream opening of a hollow valve seat extension section (4D) having an upstream opening (4G), and wherein The valve body (4A) of the check valve includes a protrusion (4C) on the side facing the valve seat (4B), and the protrusion (4C) extends through the valve seat (4B) and passes through the upstream opening (4G) of the valve seat extension section (4D), and the size of the protrusion (4C) is set to leave a gap (G) between its side surface and the inner side of the hollow valve seat extension section (4D), wherein further, the upstream end (4E) of the protrusion (4C) is configured to mechanically interact with the upstream end (4F) of the hollow valve seat extension section (4D), thereby being prevented from entering the hollow valve seat extension section (4D), thereby limiting the movement of the valve body (4A) in the downstream direction.

2. Inhalation device according to claim 1, wherein the non-return valve (4) is arranged fluidly between the reservoir (2) and the pumping unit (3).

3. Inhalation device according to claim 1, wherein the non-return valve (4) is arranged fluidically between the pumping unit (3) and the nozzle (5).

4. An inhalation device according to any one of the preceding claims, wherein the upstream end (4E) of the protrusion (4C) of the non-return valve (4) comprises at least one flexible structure, which is configured to be elastically deformable so as to fit within the hollow valve seat extension section (4D) in a deformed state, and to be permanently unfolded when arranged to pass through the hollow valve seat extension section (4D), so that the upstream end (4E) extends laterally beyond the width of the upstream opening (4G) of the hollow valve seat extension section (4D).

5. An inhalation device according to any one of claims 1 to 3, wherein a ring-like or rod-like structure is attached to the upstream end (4E) of the protrusion (4C) of the non-return valve (4), which increases the overall lateral dimension of the upstream end (4E) so that it is larger than the width of the opening (4G).

6. An inhalation device according to any one of claims 1 to 3, wherein the upstream end (4E) of the protrusion (4C) of the check valve (4) is configured to provide a magnetic force that offsets a magnetic force of a corresponding magnitude arranged inside the valve seat extension section (4D) and / or at its upstream end, so that the balance of the magnetic forces limits the movement of the valve body (4A).

7. An inhalation device according to any one of the preceding claims, wherein the diameter of the valve body (4A) is 1 mm ± 0.3 mm, and / or the length of the protrusion (4C) is 0.5 mm ± 0.4 mm, and / or the width of the gap (G) is between 50 μm and 1000 μm, and / or the upstream end (4E) laterally extends beyond the opening (4G) by at least 0.5 mm.

8. Inhalation device according to any of the preceding claims, wherein the pumping unit (3) comprises an immovable or fixed piston (3B) and a movable cylindrical part (3A).

9. Inhalation device according to any of the preceding claims, wherein the dead volume of the non-return valve (4, 7) is preferably below 500 μm 3 .

10. An inhalation device according to any one of the preceding claims, wherein the dead volume of the non-return valve (4, 7) is in the range of from about 0.001 μm 3 To about 100 μm 3 Select within the range.

11. Inhalation device according to any of the preceding claims, wherein the flow rate of the medically active liquid (L) through the opened non-return valve (4, 7) is selected in the range from about 1 μl / sec to about 100 μl / sec.

12. Inhalation device according to any of the preceding claims, wherein the non-return valve (4, 7) allows an opening and closing time of a maximum of 100 msec.

13. Inhalation device according to any of the preceding claims, wherein the medically active liquid (L) is a pharmaceutical composition comprising at least one inhalable active ingredient selected from the group consisting of long-acting muscarinic antagonists (LAMA), long-acting beta agonists (LABA) and inhaled glucocorticoids (ICS).

14. Use of an inhalation device according to any of the preceding claims for treating or preventing diseases, disorders or conditions of the respiratory system by inhaled administration of an aerosol of a medicinally active liquid (L).

15. Use of an inhalation device according to claim 14, wherein the respiratory disease, disorder or condition is a pulmonary disease, disorder or condition.

16. Use of an inhalation device according to claim 14 or 15, wherein the pulmonary disease, disorder or condition is asthma and / or chronic obstructive pulmonary disease (COPD).

17. Use of an inhalation device according to any one of claims 1 to 13 for the prevention or treatment of a respiratory disease, disorder or condition.

18. A method of treating a subject suffering from a pulmonary disease, disorder or condition or preventing a subject from developing a pulmonary disease, disorder or condition, in particular asthma and / or chronic obstructive pulmonary disease (COPD), comprising the step of administering to the subject a pharmaceutical composition in nebulized (aerosolized) form using an inhalation device according to any one of claims 1 to 13.

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