Inhalation device system with counting and blocking assembly

Abstract

The present invention relates to an inhalation device system for inhalation administration of a medically active liquid in aerosol form, the inhalation device system comprising an inhalation device (20) and a replaceable reservoir (30) for holding a plurality of doses of the medically active liquid, one dose of the medically active liquid being dispensed from the inhalation device with each actuation of the inhalation device system, the inhalation device (20) comprising: a housing (21) having a receiving unit (23), the receiving unit having a connection unit (24) adapted for releasably and fluidly connecting to a connection port (31) of the replaceable reservoir (30), the receiving unit (24) adapted for receiving the replaceable reservoir (30) and for fluidly connecting to the replaceable reservoir (30); a nozzle (25) for spraying the medically active liquid; and a pump unit (40) arranged in the housing (21), adapted for fluidly connecting to the replaceable reservoir (30) and the nozzle (25). and a pump unit (40) adapted to transport (in a downstream direction) a medically active liquid from a replaceable reservoir (30) to a nozzle (25) and adapted to move the replaceable reservoir from a rest position to a priming position upon priming of the pump unit, wherein the inhalation device system comprises a combined counting and blocking assembly comprising a counting unit for counting the number of actuations of the inhalation device system (after insertion of the replaceable reservoir into the inhalation device) and a blocking unit for blocking movement of the replaceable reservoir from the rest position to the priming position when a predetermined number of actuations is reached (after insertion of the replaceable reservoir into the inhalation device), wherein the counting unit and the blocking unit are physically separated from each other when the replaceable reservoir is in the rest position and interact with each other each time the replaceable reservoir is moved from the rest position to the priming position.

Description

[Technical field]

[0001] The present invention relates to the field of inhalation devices for medically active liquids, in particular to an inhalation device system comprising an inhalation device and a replaceable reservoir for holding a medically active liquid, the inhalation device system comprising a combined counting and prevention assembly. [Background technology]

[0002] Nebulizers or other aerosol generators for liquids have been known in the art for a long time. Among other things, such devices are used in medicine and therapy. There, they function as inhalation devices for applying an active ingredient in the form of an aerosol, i.e. small droplets embedded in a gas. Such an inhalation device is known, for example, from EP 0627230. The essential components of this inhalation device are a reservoir in which the liquid to be aerosolized is contained, a pumping device for generating a sufficiently high pressure to atomize the liquid, as well as an atomizing device in the form of a nozzle. By means of the pump device, the liquid is drawn from the reservoir in discrete amounts, i.e. not continuously, and is fed to the nozzle. The pump device operates without a propellant and generates the pressure mechanically.

[0003] Known embodiments of such an inhalation device are presented, for example, in WO 91 / 14468. In such a device, the pressure in a pump chamber connected to a housing is generated by the movement of a movable hollow piston. The piston is movably arranged inside a stationary cylinder or pump chamber. An inlet arranged on the upstream side of the hollow piston is fluidly connected to the interior of the reservoir (i.e. the reservoir tube section). Its downstream-arranged tip leads to the pump chamber. Also, a check valve is arranged inside the tip of the piston, which prevents the liquid from flowing back into the reservoir.

[0004] A further inhalation device is known from WO 2018 / 197730. The handheld inhalation device disclosed therein comprises a housing having a side facing the user, an impingement nozzle for generating a nebulized aerosol by the impingement of at least two liquid jets, the impingement nozzle being rigidly attached to the side facing the user of the housing so as to be immovable relative to the housing, a fluid reservoir arranged in the housing, and a pump unit arranged in the housing, the pump unit having an upstream end fluidly connected to the fluid reservoir and a downstream end fluidly connected to the nozzle. The pump unit is adapted to pump fluid from the fluid reservoir to the nozzle and comprises a riser pipe adapted to act as a piston in the pump unit and rigidly fixed to the side facing the user of the housing so as to be immovable relative to the housing.

[0005] WO 2017 / 076938 discloses a system with a sprayer, as well as a container with a fluid and an indicator device for such a sprayer. A check scheme is used to indicate the number of containers that have already been used with the sprayer or that can still be used with the sprayer. The indicator device indicates the number of uses that have been performed or are still possible with the current container.

[0006] WO 2019 / 016409 discloses a sprayer for spraying liquid from a container and such a container. The sprayer includes a fluid pump for drawing a dose of liquid from the container and pressurizing each dose for spraying. The container includes an air pump having a piston / cylinder arrangement for pressurizing the liquid in the container to assist in drawing the liquid from the container. A control valve limits the air pressure acting on the liquid.

[0007] Known inhalation devices or inhalation device systems generally utilize a counting and blocking system that typically counts the number of activations of a container and blocks further use of the nebulizer until the container is replaced. This combined system is often attached to the container and replaced together with the container, making the container more expensive to manufacture.

[0008] It is an object of the present invention to provide an inhalation system with a novel combined counting and blocking assembly that allows for more flexibility when used in an inhalation device or inhalation device system. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] International Publication No. 2018 / 197730 Brochure [Patent Document 2] International Publication No. 2017 / 076938 Brochure [Patent Document 3] International Publication No. 2019 / 016409 Brochure Summary of the Invention

[0010] In a first aspect, the present invention relates to an inhalation device system for administering by inhalation a medically active liquid in aerosol form, comprising: The system includes an inhalation device (20) and a replaceable reservoir (30) for holding multiple doses of the medically active liquid, such that each actuation of the inhalation device system dispenses one dose of the medically active liquid from the inhalation device; The suction device (20) - a housing (21) having a receiving unit (23), the receiving unit having a connection unit (24) adapted to releasably and fluidly connect to a connection port (31) of a replaceable reservoir (30), the receiving unit (24) adapted to receive the replaceable reservoir (30) and to fluidly connect to the replaceable reservoir (30); a nozzle (25) for spraying the medically active liquid; - a pump unit (40) arranged in the housing (21), adapted to be fluidly connected to the replaceable reservoir (30) and to the nozzle (25) and adapted to transport (in a downstream direction) a medically active liquid from the replaceable reservoir (30) to the nozzle (25) and adapted to move the replaceable reservoir from a rest position to a priming position upon priming of the pump unit; Equipped with the inhaler system comprises a combined counting and blocking assembly comprising a counting unit for counting a number of actuations of the inhaler system (after insertion of the replaceable reservoir into the inhaler) and a blocking unit for blocking movement of the replaceable reservoir from a rest position to a priming position when a predetermined number of actuations (after insertion of the replaceable reservoir into the inhaler) is reached; The counting unit and the blocking unit are physically separated from each other when the replaceable reservoir is in the rest position and are adapted to interact with each other each time the replaceable reservoir is moved from the rest position to the priming position. [Brief description of the drawings]

[0011] [Figure 1] 1 shows a cross-sectional view of an inhaler system with a prior art cartridge inserted into the inhaler; [Diagram 2] 1 shows a schematic embodiment of an inhalation device system according to the present invention; [Diagram 3] FIG. 2 shows a schematic view of the lower part of an inhalation device system showing the lower part of the device with a counting unit and a replaceable reservoir in the form of a container system with an interdiction unit. [Figure 4A] 1 shows an overview of an exemplary embodiment of a counting unit. [Figure 4B] 1 shows an overview of an exemplary embodiment of a counting unit. [Figure 4C] 1 shows an overview of an exemplary embodiment of a counting unit. [Figure 5A] 13 shows an overview of an exemplary embodiment of a blocking unit attached to an optionally replaceable reservoir. [Figure 5B] 13 shows an overview of an exemplary embodiment of a blocking unit attached to an optionally replaceable reservoir. [Figure 6A] 1 illustrates an exemplary embodiment of a counting unit and its potential interactions with a blocking unit. [Figure 6B] 1 illustrates an exemplary embodiment of a counting unit and its potential interactions with a blocking unit. [Figure 6C] 1 illustrates an exemplary embodiment of a counting unit and its potential interactions with a blocking unit. [Figure 7A] 4 shows another exemplary embodiment of the counting unit. [Figure 7B] 4 shows another exemplary embodiment of the counting unit. [Figure 7C] 4 shows another exemplary embodiment of the counting unit. [Figure 7D] 4 shows another exemplary embodiment of the counting unit. [Figure 8A] 1 shows an exemplary embodiment of a blocking unit and a blocking mechanism. [Figure 8B] 1 shows an exemplary embodiment of a blocking unit and a blocking mechanism. [Figure 8C] 1 shows an exemplary embodiment of a blocking unit and a blocking mechanism. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] The present invention provides an inhalation device system for administering by inhalation a medically active liquid in aerosol form, comprising: The system includes an inhalation device (20) and a replaceable reservoir (30) for holding multiple doses of the medically active liquid, such that each actuation of the inhalation device system dispenses one dose of the medically active liquid from the inhalation device; The suction device (20) - a housing (21) having a receiving unit (23), the receiving unit having a connection unit (24) adapted to releasably and fluidly connect to a connection port (31) of a replaceable reservoir (30), the receiving unit (24) adapted to receive the replaceable reservoir (30) and to fluidly connect to the replaceable reservoir (30); a nozzle (25) for spraying the medically active liquid; - a pump unit (40) arranged in the housing (21), adapted to be fluidly connected to the replaceable reservoir (30) and to the nozzle (25) and adapted to transport (in a downstream direction) a medically active liquid from the replaceable reservoir (30) to the nozzle (25) and adapted to move the replaceable reservoir from a rest position to a priming position upon priming of the pump unit; Equipped with the inhaler system comprises a combined counting and blocking assembly comprising a counting unit for counting a number of actuations of the inhaler system (after insertion of the replaceable reservoir into the inhaler) and a blocking unit for blocking movement of the replaceable reservoir from a rest position to a priming position when a predetermined number of actuations (after insertion of the replaceable reservoir into the inhaler) is reached; The counting unit and the blocking unit are physically separated from each other when the replaceable reservoir is in the rest position and are adapted to interact with each other each time the replaceable reservoir is moved from the rest position to the priming position.

[0013] The inhalation device system according to the invention is suitable for inhalation administration of a medically active liquid in aerosol form, the term "medically active liquid" as used herein refers to a liquid compound or composition that has pharmacological activity or that includes a compound or composition that has pharmacological activity and can ameliorate or prevent symptoms associated with a disease, disorder or condition of the respiratory system, such as a disease, disorder or condition, in a subject, particularly a warm-blooded animal or human, particularly a human disease, disorder or condition. Specific examples of such diseases, disorders or conditions include, but are not limited to, asthma and / or chronic obstructive pulmonary disease (COPD), particularly COPD, or interstitial lung diseases affecting the interstitium of the lungs and lung tissue, such as those associated with the airways and / or air sacs (alveoli), such as pulmonary fibrosis, such as idiopathic pulmonary fibrosis (IPF), interstitial pneumonia, or sarcoidosis.

[0014] Furthermore, the term "inhalation administration" as used herein refers to a route of administration in which a medically active liquid is transported to the respiratory system, particularly the lower respiratory system, such as the lungs of a subject, by inhalation by a subject of an air stream of an airborne or other carrier gas containing the medically active liquid in aerosolized form. The terms "nebulized", "aerosolized" or "atomized" as used herein synonymously refer to a state in which a medically active liquid exists in the form of an aerosol having at least two phases: a gas, such as air or another carrier gas, a continuous phase containing a dispersed liquid phase in the form of small droplets, and a liquid phase, i.e., the medically active liquid, which may itself represent a liquid solution, dispersion, suspension, or emulsion. In certain embodiments, such aerosols have respirable particles or droplets, preferably having a mass median aerodynamic diameter (measured by laser diffraction) of about 10 μm or less, particularly about 7 μm or less, or about 5 μm or less, respectively.

[0015] In certain embodiments, the term "medically active liquid" as used herein refers to a medically active liquid in the form of a pharmaceutical composition comprising at least one active pharmaceutical ingredient (API), more particularly at least one inhalable active pharmaceutical ingredient. More particularly, such at least one inhalable active pharmaceutical ingredient may be selected, for example, from long-acting muscarinic antagonists (LAMAs), long-acting beta agonists (LABAs) and inhalable glucocorticosteroids (ICS), as well as analgesics and antidiabetics, either alone or in combination with each other.

[0016] Examples of long-acting muscarinic antagonists (LAMAs) include, but are not limited to, aclidinium bromide, glycopyrronium salts such as glycopyrronium bromide, brefenacin, tiotropium such as tiotropium bromide, umeclidinium bromide, oxitropium bromide, flutropium bromide, ipratropium bromide, trospium chloride, and tolterodine.

[0017] Examples of long-acting beta agonists (LABA) include, but are not limited to, albuterol, alloformoterol, bambuterol, bitolterol, broxaterol, carbuterol, clenbuterol, fenoterol, formoterol, hexoprenaline, ibuterol, indacaterol, indacterol, isoetharine, isoprenaline, levosalbutamol, mabuterol, meladoline, metaproterenol, olodaterol, orciprenaline, pirbuterol, procaterol, reproterol, rimiterol, ritodrine, salmeterol, salmefamol, soterenoto, sulfonterol, tialamide, terbutaline, terbuterol.

[0018] Examples of inhalable glucocorticosteroids (ICS) include, but are not limited to, prednisolone, prednisone, butixocort propionate, flunisolide, beclomethasone, triamcinolone, budesonide, fluticasone, mometasone, ciclesonide, rofleponide, dexamethasone, etiprednisolone-dichloroacetate, deflazacort, etiprednol, loteprednol, RPR-106541, NS-126, and ST-26.

[0019] Further, the active pharmaceutical ingredient may be selected from analgesics such as opioid analgesics (e.g., morphine, fentanyl) or non-opioid analgesics (e.g., salicylic acid derivatives, e.g., acetylsalicylic acid) or cannabinoids (e.g., tetrahydrocannabinol), antidiabetic drugs such as insulin.

[0020] The medically active liquid or liquid pharmaceutical composition that can be nebulized or aerosolized by the inhalation device system can contain at least one active pharmaceutical ingredient as described above, but can also contain a mixture of two or more active pharmaceutical ingredients that can be administered by inhalation.

[0021] Medically active liquid or pharmaceutical compositions that can be aerosolized by the inhalation device system of the present invention are preferably formulated as compositions that are suitable and adapted for inhalation use, in other words, compositions that can be nebulized or aerosolized for inhalation and that are physiologically acceptable for inhalation by a subject.

[0022] The medically active liquid or pharmaceutical composition that may be administered by the inhalation device system or contained in a corresponding replaceable reservoir may be in the form of a dispersion, e.g., in the form of a suspension having a liquid continuous phase and a solid dispersed phase, or in the form of a solution.

[0023] In further embodiments, the medically active liquid or pharmaceutical composition may optionally include one or more physiologically acceptable excipients suitable for inhalation use. Excipients that may be featured in the composition may include, but are not limited to, one or more buffers to adjust or control the pH of the solution, salts, flavorings, surfactants, lipids, antioxidants, and co-solvents that may be used to enhance or improve solubility, e.g., ethanol or glycol.

[0024] In certain embodiments, the medically active liquid may be essentially free of propellants, such as hydrofluoroalkane (HFA) propellants.

[0025] In further particular embodiments, the medically active liquid may be an aqueous solution in which one or more of the active pharmaceutical ingredients are dissolved and solubilized in a liquid carrier solution that includes water. Such an aqueous solution may also optionally include one or more of the excipients described above.

[0026] The inhalation device system of the present invention comprises an inhalation device and a replaceable reservoir for holding a medically active liquid. The inhalation device of the inhalation device system of the present invention may in certain embodiments be a handheld device, in other words a mobile device that can be conveniently held and used in one hand and is suitable for delivering a nebulized medically active aerosol as described above for inhalation therapy. To be suitable for inhalation therapy, the device must be able to emit a medically active aerosol whose particle size is respirable, i.e. small enough to be taken up by the lungs of the patient or user with respirable particles in the aforementioned range. In this respect, the inhalation device is substantially different from devices that emit a spray for oral or nasal administration, such as those disclosed in US Patent Application Publication No. 2004 / 0068222.

[0027] The inhalation device of the present system comprises a housing defining an outer casing of the inhalation device, in particular an outer casing in which further components of the inhalation device are received and / or attached. The housing may have a user-facing side that can be contacted by a user of the inhalation device, in particular for the aforementioned inhalation administration. In a particular embodiment, the user-facing side may be a mouthpiece that can be introduced into the mouth of a user, in particular for inhalation or administration of the atomized medically active liquid.

[0028] Further, the housing may have a lower portion, preferably located at the upstream end of the inhalation device, which may be moved, opened, or removed, at least partially removed, to open the housing and allow access to a receiving unit into which a replaceable reservoir may be inserted. As used herein, the term "upstream" refers to the direction or location in relation to the present inhalation device, inhalation device system, cartridge system, or other component, along which the medically active liquid is delivered by the inhalation device during operation. In contrast, as used herein, the term "downstream" refers to the opposite direction or location in relation to which the medically active liquid is delivered by the inhalation device during operation.

[0029] Said lower part of the housing is preferably movable to give access to the receiving unit as defined below. In one embodiment this corresponds to a movable element providing access to the receiving unit. In some embodiments said movable element is permanently attached to the housing, in certain embodiments said movable element is connected to the housing, for example by a hinge. In other embodiments the movable element is removable from the housing.

[0030] In some embodiments, the housing of the inhalation device has a fixed part comprising the pump unit, the nozzle and the receiving unit, and at least one movable part, which is movable from a closed state and an open state, and / or from a rest position to a priming position.

[0031] The inhalation device, more specifically the housing of the inhalation device, comprises a receiving unit adapted to receive a replaceable reservoir or cartridge system, as described in more detail below. The receiving unit has a connection unit adapted to releasably and fluidly connect to a connection port of the replaceable reservoir. The term "fluidly connect" as used herein means that, with respect to two connection elements, a preferably gas-tight and / or liquid-tight connection is established or may be established, preferably allowing the transfer of a fluid, such as a gas or a liquid, from one element to the other, such that such fluid is preferably transferred completely from one element to the other.

[0032] In some embodiments, the movable part of the housing is in the form of a cap that closes over the receiving unit of the housing.

[0033] The receiving unit of the housing is adapted to receive or, in some embodiments, completely receive and fluidly connect with the replaceable reservoir, as will be explained in more detail below, which, in particular with regard to the term "completely receive" as used herein, means that such a replaceable reservoir can be completely introduced into the receiving unit of the housing, such that the receiving unit and the housing can completely enclose or contain the replaceable reservoir, preferably such that a surface of the replaceable reservoir when introduced into the receiving unit is completely enclosed by the housing of the inhalation device.

[0034] The inhalation device of the system of the present invention further comprises a nozzle for spraying the medically active liquid. The skilled person knows different types of nozzles suitable for spraying, aerosolizing or atomizing the medically active liquid administered by the system of the present invention, such as impingement nozzles, swirl nozzles, orifice nozzles, surface impingement nozzles or multi-fluid nozzles. However, in a particular embodiment, the nozzle of the inhalation device is of the impingement type. This means that the nozzle is adapted to emit at least two liquid jets that are directed to collide and break into small aerosol droplets. In a particular embodiment, the nozzle is rigidly fixed to the housing, in particular to the side of the housing of the inhalation device that faces the user, so that it is immobile or immovable relative to the housing, or at least to the side or part of the housing that faces the user (e.g., patient), or more specifically, to be introduced into the mouth of the user when the device is used.

[0035] The inhalation device of the system of the invention further comprises a pump unit arranged in the housing of the inhalation device. The pump unit is adapted to be fluidly connected to the reservoir, in particular via a connection unit of the receiving unit. In a particular embodiment, the pump unit is fluidly connected to the reservoir via a connection unit of the receiving unit. Furthermore, the pump unit is also adapted to be fluidly connected to the nozzle, or in a particular embodiment, is connected to the nozzle, and further adapted to convey, in other words pump, the medically active liquid in a downstream direction from the reservoir to the nozzle.

[0036] The pump unit included in the inhalation device of the present invention is suitable and adapted to deliver the nebulized medically active liquid in a discontinuous manner, i.e., in the form of individual units, in a particular embodiment, one unit per pump cycle. In this aspect, the inhalation device differs from commonly known nebulizers, such as jet nebulizers, ultrasonic nebulizers, vibrating mesh nebulizers, or electrohydrodynamic nebulizers, which generate and deliver nebulized aerosol continuously, typically over a period of several seconds to several minutes, so that the aerosol requires multiple successive breathing maneuvers to be inhaled by the patient or user. Instead, the inhalation device of the present invention is adapted to generate and release individual aerosol units, each unit corresponding to the amount (i.e., volume) of fluid (i.e., medically active liquid) pumped by the pump unit in one pumping cycle to the nozzle, where it is immediately aerosolized and delivered to the user or patient. Conversely, the amount of liquid pumped by the pump unit in one pumping cycle determines the amount of pharmacologically active agent that the patient receives per dose. It is therefore very important that the pump unit operates accurately, reliably and reproducibly with respect to achieving the desired therapeutic effect. Such inhalation devices exhibiting high accuracy and reproducibility, in particular inhalation devices incorporating pump units as described in more detail below, are known to those skilled in the art and are described in WO 2018 / 197730, the disclosure of which is incorporated herein in its entirety. However, it should be noted that the specific design of the pump unit may be modified and further pump units, such as those described in US 2012 / 0090603, the disclosure of which is incorporated herein by reference in its entirety, may also be used in the inhalation device of the present invention.

[0037] In a particular embodiment, the pump unit may also be arranged in the housing and may be adapted to function as a piston pump, also called a plunger pump, with the riser pipe acting as a piston or plunger that is longitudinally movable in a hollow cylinder. The pump unit may have an upstream end fluidly connected to a replaceable reservoir and a downstream end fluidly connected to a nozzle. In a further particular embodiment, the pump unit may comprise a riser pipe that may be adapted to function as a piston in the pump unit, a hollow cylinder, and lockable means for storing potential energy. The lockable means may be adapted to store potential energy when locked and release the stored energy when unlocked, such as a spiral spring or other elastic element. The lockable means may be arranged outside the hollow cylinder and mechanically coupled to it, such that unlocking the means propels the cylinder longitudinally towards the downstream end of the pump unit. An inner segment of such a hollow cylinder, in which the upstream end of such a riser pipe moves, forms a pump chamber with a variable volume depending on the position of the riser pipe relative to the cylinder.

[0038] In general, when the lockable means for storing potential energy is locked and storing potential energy, the inhaler system is in a primed state and in said primed state the reservoir is in a primed position, and when the lockable means for storing potential energy is released and unlocked the inhaler system is in a rest state and the replaceable reservoir is in a rest position.

[0039] The hollow cylinder providing the pump chamber may be fluidly connected, directly or indirectly, to a replaceable reservoir, or more specifically to a connection port of the replaceable reservoir, such as by an optional reservoir pipe (or reservoir pipe section). Similarly, a riser pipe having an internal (upstream) end facing the reservoir and which may be received in the hollow cylinder, may be fluidly connected, directly or indirectly, at its downstream or external end in a liquid-tight manner to a nozzle.

[0040] In this context, the expression "hollow cylinder" refers to a part or member that is hollow in the sense that it has a cylindrical shape or contains an internal cavity with a segment having a cylindrical space. In other words, the external shape of the respective part or member does not have to be cylindrical, as is applicable to other types of piston pumps. Moreover, the expression "hollow cylinder" does not exclude an operating condition of the respective part or member in which the "hollow" space may be filled with a material, for example a liquid to be sprayed.

[0041] As used herein, longitudinal motion is motion along the major axis of the hollow cylinder, and propulsive motion is motion of the part in the downstream (or forward) direction.

[0042] In certain embodiments, the riser pipe of the pump unit of the inhalation device of the present invention may be arranged downstream of the cylinder and may be rigidly fixed to the user-facing side of the housing so as to be immovable relative to the housing or at least a part of the housing including the user-facing side of the housing. For the avoidance of doubt, the term "rigidly fixed" means fixed directly or indirectly (i.e. via one or more connections) so as to prevent relative movement between the respective parts. Since the nozzle is also preferably immovable relative to the housing or the respective part of the housing, the riser pipe is also preferably immovable relative to the nozzle and the pumping action is in these embodiments brought about by the longitudinal movement of the hollow cylinder. The propulsive movement of the cylinder, which in this embodiment is arranged in an upstream position relative to the riser pipe, leads to a decrease in the volume of the pump chamber and the repulsive movement of the cylinder leads to an increase in the volume. In other words, in these embodiments, the riser pipe maintains its position relative to the housing and the hollow cylinder can change its position relative to the housing to perform an in-cylinder piston-type movement of the immovable riser pipe in the movable cylindrical member, in particular along its longitudinal axis.

[0043] This configuration differs from other impingement type suction devices that rely on a pump unit with its riser pipe in an upstream position and a cylindrical member in a downstream position, as disclosed in US Patent Application Publication No. 2012 / 0090603, in which the riser pipe is movable and the cylindrical member is fixed to the housing. An important advantage of devices with fixed riser pipes as described above is that the passage between the pump chamber and the replaceable reservoir can be designed with fewer restrictions regarding its dimensions. Such devices are easier to manufacture, since they can accommodate very large inlet valves (also called check valves), which do not have to be accommodated in the narrow riser pipe. Instead, the fixed riser pipe design of the pump unit allows the use of check valves whose size is limited only by the internal size of the housing or the dimensions of the means for storing potential energy. In other words, the diameters of the valve, the riser pipe, and, if used, the reservoir pipe, do not have to match each other. Moreover, since in this embodiment there is no need to connect the movable piston to the replaceable reservoir, the component providing the fluid connection to the reservoir can be designed independently of the movable component, i.e. the hollow cylinder, allowing the individual parts to be adapted to suit their respective individual functions. In this respect, the fixed riser pipe design according to this particular embodiment offers greater design flexibility, since the movable hollow cylinder, due to its robust structure and dimensions, offers a better opportunity to design a mechanically stable connection with the reservoir than the less robust movable riser pipe. Also, in this embodiment, the connection between the hollow cylinder and the replaceable reservoir can be designed with a larger diameter, so that higher flow rates and fluid viscosities are feasible. Furthermore, the support of the replaceable reservoir can be integrated into any component, including the cylinder. Furthermore, in this embodiment, any vent for pressure equalization of the replaceable reservoir can be moved away from the reservoir body itself, for example to a connector forming an interface between the replaceable reservoir and the hollow cylinder of the pump unit, thus facilitating the construction and avoiding the need to provide an essentially "open" reservoir body.This is particularly important when the reservoir is designed as a replaceable reservoir, as is the case in the present invention.

[0044] As mentioned above, the lockable means for storing potential energy may be adapted to store energy in its locked state and to release the stored energy when unlocked. In a particular embodiment, the lockable means is mechanically coupled to the hollow cylinder such that unlocking the means results in a propulsive longitudinal movement of the hollow cylinder towards the downstream end of the pump unit. During this movement, the internal volume of the cylinder, i.e. the volume of the pump chamber, decreases. Conversely, when the means for storing potential energy is in the locked state, the hollow cylinder is in its most upstream position where the volume of the pump chamber is maximum. The locked state can also be considered as a priming state. When the state of the means for storing energy is changed from the unlocked state to the locked state, which may be referred to as priming of the device, the hollow cylinder undergoes a repulsive longitudinal movement, i.e. from its most downstream position towards its most upstream position. A pumping cycle consists of two subsequent opposing movements of the hollow cylinder, starting from its most downstream position to its most upstream (or primed) position and then driven by a lockable means for storing potential energy which then releases that energy, back to its most downstream position. In a preferred embodiment, the replaceable reservoir moves with the hollow cylinder during said movements.

[0045] In a particular embodiment, the pump unit is a high pressure pump unit and is adapted to operate or expel fluid at a pressure of at least about 50 bar. In other preferred embodiments, the operating pressure of the pump unit is at least about 10 bar, or at least about 100 bar, or from about 2 bar to about 1000 bar, or from about 50 bar to about 250 bar, respectively. As used herein, the operating pressure is the pressure at which the pump unit expels the medically active liquid to be administered, such as an inhalable aqueous liquid formulation of a medically active ingredient, from its pumping chamber in a downstream direction, i.e., towards the nozzle. In this context, the expression "adapted to operate" means that the components of the pump unit are selected with respect to materials, dimensions, surface quality and finish to allow operation at the specified pressure.

[0046] Furthermore, such a high pressure pump unit means that the lockable means for storing potential energy is capable of storing and releasing a sufficient amount of energy to drive propulsive longitudinal movement of the cylinders with such force that the respective pressures are obtained.

[0047] The lockable means for storing potential energy may be designed as a tension or pressure spring. Alternatively, besides metal or plastic bodies, gaseous media or magnetic materials may also be used as energy storage means. By compression or tension, potential energy is supplied to the means. One end of the means may be supported in a housing or in a housing at a suitable position, so that this end is essentially immobile. The other end may be connected to a hollow cylinder of the pump unit providing the pump chamber, so that this end may be essentially mobile. The means for storing potential energy may be locked after loading a sufficient amount of energy and may store energy until unlocking occurs. When unlocked, the means may release potential energy (e.g. spring energy) to the cylinder with the pump chamber, which is then driven to perform a (in this case longitudinal) movement. Typically, the energy release occurs suddenly, so that a high pressure may build up in the pump chamber before a significant amount of medically active liquid is released, which causes the pressure to drop. In fact, during a significant portion of the ejection phase, there is an equilibrium between the pressure delivered by the potential energy storage means and the amount of medically active liquid already ejected.The amount of medically active liquid therefore remains essentially constant during this phase, which is a great advantage over devices that use the user's manual force for ejection, such as those disclosed in documents US2005 / 0039738, US2009 / 0216183, US2004 / 0068222 or US2012 / 0298694, because the manual force depends on the individual user or patient and is very likely to vary significantly during the ejection phase, resulting in non-uniform droplet formation, size and amount.In contrast to the prior art, the measures according to the present invention ensure that the inhalation device delivers highly reproducible results.

[0048] In a further embodiment, the means for storing potential energy may also be provided in the form of a highly pressurized gas container. By proper placement and its repeatable intermittent activation (i.e., opening), a portion of the energy stored in the gas container can be released into the cylinder. This process can be repeated until the remaining energy is insufficient to re-establish the desired pressure in the pump chamber. After this, the gas container must be refilled or replaced.

[0049] In certain embodiments, the lockable means for storing potential energy is a spring having a load of at least 10 N in a deflected state. In preferred embodiments, the means for storing potential energy is a steel compression spring having a load of about 1 N to about 500 N in a deflected state. In other preferred embodiments, the steel compression spring has a load of about 2 N to about 200 N, or about 10 N to about 100 N in a deflected state.

[0050] In one preferred embodiment, a single dose of medicament (i.e., aerosol of a medically active liquid) is contained in one unit, i.e., the amount delivered from the pump unit to the nozzle to generate the aerosol in one pumping cycle, in which case the user or patient primes and actuates the device only once and inhales the emitted aerosol in one breathing maneuver per dose (i.e., per dosing event).

[0051] In another preferred embodiment, a single dose of the drug consists of two units of aerosol, thus requiring two pumping cycles. Typically, a user or patient primes the inhalation device, activates the inhalation device to release and inhale a unit of aerosol, and then repeats the procedure. Alternatively, three or more aerosol units may constitute a single dose.

[0052] The amount of fluid (e.g., medically active liquid) pumped by the pump unit of the inhalation device system in one pumping cycle may preferably be in the range of about 0.1 μL to about 1000 μL, or about 1 μL to about 250 μL, or about 2 μL to about 150 μL. In particular, the amount may be in the range of about 2 μL to about 50 μL, or about 5 μL to about 25 μL, more specifically about 10 μL to about 20 μL, for example about 15 μL. These amount ranges are approximately the same as the volume of the liquid phase contained in one unit of aerosol generated by the inhalation device, with slight differences possibly due to minute losses of liquid in the device.

[0053] In a further particular embodiment, the pump unit of the inhalation device comprises an inlet valve, also called a check valve or inlet check valve, arranged in the hollow cylinder. According to this embodiment, the interior space of the hollow cylinder, i.e. the pump chamber, is fluidly connected with the fluid reservoir via the inlet check valve. The inlet valve allows the inflow of liquid into the pump chamber but prevents the backflow of medically active liquid into or into the replaceable fluid reservoir. In a preferred embodiment, the location of the inlet valve may be at or near the upstream end of the cylinder, so as to make almost the entire internal volume of the hollow cylinder available to function as the pump chamber. Alternatively, the inlet valve may be more centrally located along the main (longitudinal) axis of the hollow cylinder, so as to define an upstream segment and a downstream segment of the cylinder, the upstream segment being upstream of the inlet valve and the downstream segment being downstream of the valve. In this case, the pump chamber is located in the downstream segment.

[0054] As mentioned above, one of the advantageous effects of certain embodiments of pump units with fixed or immovable pistons is that an inlet valve with a relatively large size can be accommodated at this position, i.e., at the upstream end of the pump chamber.This is particularly beneficial, since it allows for a large size of the fluid conduit in the valve, and thus allows for a high fluid velocity that leads to a rapid filling of the pump chamber during the priming of the inhalation device.Furthermore, the use of medically active liquids with a higher viscosity than normal liquid formulations for inhalation, such as high-concentration solutions of soluble active ingredients, becomes feasible for inhalation therapy.

[0055] In a further embodiment, the inlet valve may be adapted to open only if the pressure difference between the upstream and downstream sides of the valve, i.e. the fluid reservoir side and the pump chamber side, exceeds a certain threshold value, and remains closed as long as the pressure difference is below the threshold value. In this context, the term "pressure difference" means that only the relative pressure difference between the two sides is relevant to determine whether the valve blocks or opens, regardless of the absolute pressure value. For example, if the pressure on the upstream (reservoir) side is already positive (e.g. 1.01 bar due to thermal expansion), but the pressure on the downstream (pump chamber) side is at ambient pressure (e.g. 1.0 bar, without activation of the device), the valve will remain closed even if a positive pressure is applied in the opening direction, since the pressure difference (here 0.01 bar) is below the threshold value (e.g. 20 mbar). This means that the check valve remains closed until the threshold pressure is met, thus safely keeping the passage between the reservoir and the pump chamber closed, for example when the suction device is not in use. Examples of threshold pressure differentials are in the range of 1 to 1000 mbar, more preferably between about 10 to about 500 mbar, or between about 1 to about 20 mbar.

[0056] When the inhaler of the inhaler system is actuated, when the potential energy storing means changes its state from a locked state to an unlocked state, energy is released that causes the cylinder to perform its propulsive longitudinal movement, and a significant pressure builds up in the pump chamber, which creates a significant pressure differential due to the high pressure in the pump chamber and the substantially lower pressure in the fluid reservoir exceeding the pressure differential threshold, resulting in the check valve opening and allowing the pressure chamber to fill with medical fluid from the replaceable reservoir.

[0057] A valve type that can be designed to operate at such a threshold pressure differential is a spring preloaded ball valve. The spring presses a ball into its seat and the ball valve opens only if the pressure acting on the spring force exceeds the spring force. Other valve types that can operate at such a threshold pressure differential, depending on their construction, are duckbill or flap valves.

[0058] The advantage of such a valve operating at a threshold pressure differential is that the reservoir can remain closed until the inhalation device is actively used, thus reducing undesirable splashing of medically active liquid stored in the cartridge system during transport of the device, or evaporation during long-term storage of the device.

[0059] In a further particular embodiment, the suction device of the system according to the invention may further comprise an outlet valve inside the riser pipe or at the end of the riser pipe in order to avoid a return flow of liquid or air from the riser pipe into the hollow cylinder. In many cases, the use of such an outlet valve proves to be advantageous. Typically, the downstream end of the riser pipe is located near the nozzle. The nozzle is in fluid communication with the outside air. After releasing in aerosolized form the amount of medically active liquid delivered from the pump unit through the nozzle, driven by the longitudinal propulsive movement of the cylinder, the pump chamber must be refilled. For this purpose, it slides back on the riser pipe to its previous upstream position (i.e. performs a repulsive longitudinal movement) so that the internal volume of the pump chamber increases. This creates a relative negative pressure "negative pressure" inside the pump chamber, which draws liquid into the pump chamber from a replaceable reservoir located upstream of the pump chamber. However, such a relative negative pressure can also propagate downstream through the riser pipe to the outside of the nozzle, which may lead to air being sucked into the device through the nozzle or through the nozzle opening. This problem can be avoided by providing an outlet valve, also called an outlet check valve, which opens towards the nozzle opening and blocks in the opposite direction.

[0060] Optionally, the outlet valve is of the type that blocks below a threshold pressure difference (and opens above a threshold pressure difference), as described in connection with the inlet valve above. If a ball valve with a spring is used, the spring force must be directed towards the pump chamber so that the outlet valve opens when the difference between the internal pressure of the pump chamber and the ambient pressure exceeds a threshold pressure difference value. The advantages of such a valve correspond to the respective advantages discussed above.

[0061] As mentioned above, the outlet valve may be located in the riser pipe as mentioned above. Alternatively, the suction device is not integrated in the riser pipe, but comprises an outlet valve located at or near one end of the riser pipe, in particular at or near its downstream end, for example in a separate connector between the riser pipe and the nozzle. This embodiment may be advantageous in certain cases, for example when a riser pipe with a particularly small diameter is required, which makes the integration of the valve difficult. By accommodating the outlet valve downstream of the riser pipe, a valve with a relatively large diameter can be used, thus simplifying the valve design requirements.

[0062] In a further alternative embodiment, there is no exit valve. This embodiment may be feasible since the fluid channel of the impingement nozzle may have a relatively small cross section, resulting in little or very slow backflow of medically active liquid at given pressure conditions during priming of the inhalation device. If the amount of backflow is deemed acceptable given the particular product application, the inhaler design may be simplified by avoiding the exit valve.

[0063] In either case, whether the inhalation device has an outlet valve or not, all other options and preferences discussed with respect to other device features are applicable to both of these alternative embodiments.

[0064] The replaceable reservoir for holding the medically active liquid contained in the inhalation device system of the present invention is provided in the form of a cartridge system. The cartridge system of the present invention has a total volume V o The term "total volume" as used herein refers to the containment of the entire cartridge system, including all its components such as the outer wall of the cartridge system. o In typical embodiments, may be selected within the range of about 0.1 mL to about 100 mL, or about 0.1 mL to about 50 mL, or about 0.2 mL to about 30 mL, for example, about 2.5 mL to about 20 mL, or about 5 mL to about 15 mL.

[0065] The replaceable cartridge system of the present invention has an upstream end and a downstream end and has an effective volume V for holding a medically active fluid. e and a connection port adapted to releasably and fluidly connect the cartridge system to a pump unit, in particular via a connection unit of a receiving unit of an inhalation device.

[0066] In a typical embodiment, the container portion of the replaceable cartridge system has an effective volume V selected within a range of about 0.1 to about 50 mL, or about 0.1 mL to about 25 mL, or about 1 mL to about 15 mL, or about 1 to about 10 mL, specifically about 3 mL to about 6 mL, or about 6 mL to about 9 mL, more specifically about 4.0 mL to about 5.0 mL, or about 7.0 mL to about 8.0 mL. e has.

[0067] In certain embodiments, the connection port of the container part may be in the form of a cap, such as a cap attached to the downstream end of the container part. The connection port may have an opening that allows for establishing a fluid connection to the inner lumen of the container part and the medically active liquid contained therein. The term "effective volume" refers to the containment of the entire container part, including all its components, such as the outer wall of the container part or a connection port, such as a cap. The term "lumen" or "inner lumen" as used herein in relation to a hollow body, such as a container part, refers to an internal space or cavity inside such a hollow body, regardless of whether such an internal space or cavity is completely or only partially surrounded by the outer wall of said hollow body.

[0068] In further particular embodiments, the container part of the replaceable cartridge system may be in the form of a flexible container, or in the form of a rigid or in other words dimensionally stable container. The terms "rigid" or "dimensionally stable" as used herein mean that the container part does not change its shape or volume when the medically active liquid contained therein is expelled from the container during standard operation of the inhalation device system, or in other words when the medicamentously active liquid is drawn from the container part by the pump unit during nebulization and administration of the medically active liquid. In a particular embodiment of the inhalation device system, the container part of the replaceable cartridge system is in the form of a dimensionally stable container. In a further particular embodiment, the container part of the replaceable cartridge system is in the form of a dimensionally stable container comprising a flexible or collapsible inner container, as described in more detail below, the inner container comprising the medically active liquid to be administered by the inhalation device system of the present invention.

[0069] In general, the container part can have any suitable shape that allows the container part or the entire replaceable cartridge system including such a container part to be introduced into the inhalation device of the inhalation device system, especially when provided in a dimensionally stable form. In certain embodiments, suitable shapes include, but are not limited to, bottle-shaped or tubular or cylindrical, and symmetrical and asymmetrical shapes can be implemented. In particular, with regard to the axial symmetry of the entire container device or cartridge system with respect to the main rotation axis of the container device or cartridge system connecting the center of its upstream end to the center of its downstream end, this can allow advantageous embodiments in which the container device or cartridge system may or may not be inserted into the inhalation device only in a certain orientation. However, in a preferred embodiment, the entire inhalation device or cartridge system may have a substantially circular cross-sectional shape so that the container device or cartridge system can be introduced into the inhalation device regardless of the rotation direction around the main longitudinal axis.

[0070] In a further embodiment, the container part may be in the form of a bottle, preferably with a (main) opening at its downstream end, for filling or discharging the medically active liquid to be accumulated and administered. It should be noted, however, that the container part may also be provided with further (smaller) openings, e.g. for ventilation purposes.

[0071] In certain embodiments, the container portion of the replaceable reservoir holds a medically active liquid and has a maximum internal volume V i As used herein in reference to the container portion, an "inner volume" (V i The term V ) refers to the total internal volume of the container part that can be filled (partially or completely) with a liquid, in particular with a medically active liquid to be administered by the inhalation device system according to the present invention. Thus, the internal volume V of the container part that is completely filled with a medically active liquid is i corresponds to the volume of medically active liquid contained in such a completely filled container section. In an exemplary embodiment, the maximum internal volume V i is the effective volume of the container V e , and may be selected within the range of preferably 0.1 to about 15 mL, or about 1 to about 10 mL, specifically about 3 mL to about 6 mL, or about 6 mL to about 9 mL, more specifically about 4.0 mL to about 5.0 mL, or about 7.0 mL to about 8.0 mL. However, in a further embodiment, the maximum internal volume Vi of the optional inner container is selected within the range of the effective volume V of the container part. e may be smaller than the optional inner container, resulting in a situation where the entire lumen of the container part is not filled with the optional inner container.

[0072] For example, the inner container that may be accommodated in the container part of the reservoir may be designed to be foldable, such as by flexible or elastic walls. The effect of such a design is that upon repeated use of the device, including the gradual emptying of the reservoir, the flexible or elastic walls buckle or fold, reducing the internal volume of the reservoir, so that the negative pressure required for the extraction of a certain amount of liquid does not have to increase substantially over the period of use. In particular, the optional inner container of the replaceable reservoir may be designed as a collapsible bag. The advantage of a collapsible bag is that the pressure in the reservoir is almost independent of the filling level and the effects of thermal expansion are almost negligible. Also, the structure of such a reservoir type is rather simple and already well established. However, in further embodiments, the inner container may have a non-flexible or rigid form in which pressure equilibrium with the ambient atmosphere during administration of the medical liquid stored inside is achieved by other means, such as an inlet valve or a movable piston.

[0073] The container part of the cartridge system can in certain embodiments be made or manufactured from a polymeric material, in particular from a thermoplastic polymer such as polyethylene, polypropylene, polyoxymethylene (POM), polystyrene, etc. In another embodiment, the container part may be made from a metal such as stainless steel, aluminum or other suitable metal or mixtures thereof. However, in a preferred embodiment, the container part is made from polyethylene or polypropylene, preferably polypropylene. However, it should be noted that separate structures of the container part, such as the connection port, preferably in the form of a cap, may be formed from the same or another metallic or non-metallic material as previously mentioned.

[0074] In general, the cartridge system may have a symmetrical or asymmetrical cross-sectional shape. An asymmetrical cross-section may be advantageous when it may be important that the cartridge system can only be introduced or received in a receiving unit of an inhalation device in a specific orientation. On the other hand, it may be beneficial for the cartridge system to have a symmetrical cross-section, such as a circular cross-section (perpendicular to the main central axis connecting the downstream end with the upstream end of the replaceable cartridge system), especially to facilitate the insertion of the cartridge system, for example for infants or disabled users.

[0075] The inhaler system of the present invention comprises a combined counting and blocking assembly comprising a counting unit for counting the number of actuations of the inhaler system and a blocking unit for blocking movement of the replaceable reservoir from the rest position to the priming position when a predetermined number of actuations is reached, the counting unit and the blocking unit being physically separated from each other when the replaceable reservoir is in the rest position and interacting with each other every time the replaceable reservoir moves from the rest position to the priming position.

[0076] In a preferred embodiment, the blocking and counting assembly is manually operated and does not include any electronic elements.

[0077] The blocking unit of the assembly prevents further use of the reservoir after a predetermined number of uses. The inhaler system may comprise further blocking mechanisms that prevent use of the inhaler system under certain conditions. An example of such a blocking system can be found in WO 2019 / 122451. If further blocking systems are included in the inhaler system, the blocking systems can operate in conjunction with each other or independently of each other.

[0078] The counting and blocking assembly of the invention is characterized in that while the replaceable reservoir is in the rest position, the blocking unit and the counting unit are physically separated from each other, as a result both units can be reset and / or replaced separately from each other.

[0079] Physically separated from each other in the context of the present invention means that the moving parts of the counting assembly are not in contact with the moving parts of the blocking assembly when the reservoir is in the rest position. In some embodiments, the counting unit and the blocking unit may each independently include a housing that separates the two compounds. The housings of the respective units may or may not be in permanent contact and are provided with openings that allow the moving parts of the blocking unit and the counting unit to interact with each other when the reservoir is moving.

[0080] In a preferred embodiment, the blocking unit and the counting unit each comprise a housing that separates the two systems. Preferably, the two housings do not touch each other when the replaceable reservoir is in the rest position, and are in contact or at least in close proximity when the replaceable reservoir is in the priming position.

[0081] When the inhalation device is ready for use and the reservoir is moved to the priming position, the counting assembly and the blocking assembly interact. In the context of the present invention, interaction refers to the physical proximity of at least two units. In a preferred embodiment of the present invention, the counting unit and the blocking unit of the combined counting and blocking assembly interact with each other upon the movement of the reservoir.

[0082] The interaction can be a two-sided interaction or a one-sided interaction. Preferably, the type of interaction depends on the state of the inhalation device system. For example, in one embodiment, when a replaceable reservoir is replaced and no longer in use, the blocking unit and the counting unit interact in both directions, the blocking unit resets the counting unit and the counting unit activates the blocking unit. When a predefined number of uses of the reservoir is reached, the interaction activates a blocking mechanism of the blocking unit, preventing further use of the reservoir. If the reservoir is in use and the predefined number of uses has not been reached, the blocking unit can activate the counting unit.

[0083] The outcome of said interaction between the blocking unit and the counting unit preferably depends on the state of the inhalation device and the replaceable reservoir. For example, if a new reservoir is inserted, the interaction between the counting unit and the blocking unit can reset the counting unit and / or initialize the blocking unit. After a certain number of uses, the interaction between the counting unit and the blocking unit activates the blocking unit and prevents further use of the reservoir. Between these two states, the interaction can be limited and can only involve contacting the two units, i.e. contacting a movable part of one unit with a movable part of the other unit, or the interaction is limited to moving a part of one unit by the other unit entering an opening in the housing of the unit. In some embodiments, the counting unit is preferably resettable after or by replacement of the reservoir. Preferably, the counting unit comprises indexing means for indexing the number of actuations and / or the number of remaining uses of the inhalation device system before replacement of the reservoir.

[0084] In a particular embodiment, the blocking unit resets or activates the counting unit after a new replaceable reservoir is inserted during an interaction, and the counting unit activates an inhibition mechanism within the blocking unit. If the device is used after the replaceable reservoir is inserted but the maximum number of uses with the reservoir has not been reached, the blocking unit activates the counting unit to count the number of uses during each interaction. Once a predetermined number of uses has been reached, the counting unit activates the blocking unit to prevent further use of the reservoir.

[0085] In some embodiments, the interaction of the units is achieved by a movement of one of the units. In a preferred embodiment, the blocking unit is movable or moves axially or longitudinally during the priming step of the device, thereby interacting with the counting unit, while the counting unit remains in the same axial position. In some embodiments, the counting unit is movable or moves axially or longitudinally during the priming step of the device, thereby interacting with the blocking unit.

[0086] The counting unit and the blocking unit may be rigidly attached to the inhaler system or a part thereof. The counting and blocking units may be attached or connected to different parts of the inhaler system. In some embodiments, one unit is attached to the housing and the other unit is attached to a replaceable reservoir. In some embodiments, one unit is reversibly replaceably attached to the housing and the other unit is fixed to the replaceable reservoir. In some embodiments, one unit is permanently attached to the housing or a part thereof and the other unit is permanently attached to the replaceable reservoir and is replaced with the reservoir.

[0087] In some embodiments, the metering unit is attached to the housing of the inhalation device system. In certain embodiments, the metering unit is attached to a lower housing part. In some embodiments, the housing part is movable or removable. In some embodiments, the metering unit is removably connected to the housing part. In other embodiments, the metering unit is permanently connected to the housing part. The housing part can be moved or removed to allow replacement of the replaceable reservoir.

[0088] In some embodiments, the metering unit is attached to an inner surface of a housing of the inhalation device system. In certain embodiments, the metering unit is removably attached to the inner surface of the housing. In other embodiments, the metering unit is permanently attached to the inner surface of the housing. In some embodiments, the metering unit is attached to the inner surface of a movable portion of the housing.

[0089] In some embodiments, one unit of the counting and blocking assembly is attached to the replaceable reservoir. In a preferred embodiment, the blocking unit of the combined assembly is attached to the replaceable reservoir. In some embodiments, the blocking unit is rigidly attached to the replaceable reservoir and is replaced with the reservoir. In these embodiments, the blocking unit moves with the reservoir in the inhaler system. To allow smooth operation of the inhaler system, it is preferred that the entire cartridge assembly does not interfere with the inhaler body. Therefore, it is preferred that the blocking unit has substantially the same cross-sectional diameter as the replaceable reservoir. In some embodiments, the cross-sectional diameter is smaller than the cross-sectional diameter of the reservoir. It is particularly preferred that the blocking unit and the replaceable reservoir have a circular cross-section.

[0090] The blocking unit can be attached to the replaceable reservoir by any means. A person skilled in the art will know suitable attachment means. The blocking unit may be glued or welded to the replaceable reservoir. Preferably, the blocking unit is attached to the outer surface of the replaceable reservoir. In some embodiments, the blocking unit is attached to the outer surface of the replaceable reservoir by a pressure-fit or form-fit connection.

[0091] The blocking unit can be attached to the replaceable reservoir via a housing of the blocking unit. The housing of the blocking unit may comprise an opening at its downstream end which connects to the replaceable reservoir. The opening of the housing of the blocking unit ideally has a diameter corresponding to the outer diameter of the upstream end of the replaceable reservoir. Said opening may, for example, comprise a screw thread for connecting the blocking unit to the replaceable reservoir.

[0092] The replaceable reservoir may be in the form of a replaceable cartridge having an upstream end and a downstream end, with the blocking unit attached to the upstream end of the replaceable reservoir.

[0093] If the inhibition unit is attached to a replaceable reservoir, the inhibition unit and the replaceable reservoir are preferably assembled and sterilized prior to filling the reservoir with the medically active liquid.

[0094] It is preferred if the blocking unit cannot or is difficult to remove from the reservoir. In preferred embodiments where the blocking unit is attached to a replaceable reservoir, the force required to remove the blocking unit from the replaceable reservoir is higher than the force required to remove the replaceable reservoir from the receiving unit of the inhalation device. In these embodiments, the blocking unit is replaced together with the reservoir.

[0095] In some embodiments, the replaceable reservoir is provided in the form of a bag, in particular in the form of a cartridge having an outer (dimensionally stable) shell comprising an inner container for holding the medically active liquid in the form of a collapsible bag, and the blocking unit is attached to the shell.

[0096] In some embodiments, the replaceable reservoir with the blocking unit has a cylindrical shape with a central longitudinal axis (A) connecting the connection port (32) of the replaceable reservoir (30) located at the downstream end of the replaceable reservoir (31) with the upstream end of the blocking unit attached to the upstream end of the replaceable reservoir.

[0097] The blocking unit includes a blocking mechanism.

[0098] In some embodiments, the blocking unit further comprises a housing comprising the blocking mechanism. In a preferred embodiment, the blocking unit comprises a housing and a blocking mechanism, the housing of the blocking unit comprising an opening for interaction between the counting unit and the blocking mechanism. In some embodiments, said opening is located at an upstream end of the blocking unit.

[0099] The blocking mechanism preferably prevents the replaceable reservoir from moving from the rest position to the priming position after activation.

[0100] Movement may be prevented by the blocking unit itself or by interacting with other parts of the inhaler system. In a preferred embodiment, said blocking mechanism blocks movement of the replaceable reservoir in association with the activation mechanism of the counting unit.

[0101] The counting unit comprises a counting mechanism and an actuation mechanism. The counting mechanism counts actuations of the inhaler system. The term actuation of the inhaler system refers to all steps for initiating the release of fluid. These steps include actuating a mechanism that rotates the lower housing part, thereby moving the reservoir to the priming position, and actuating an actuator member to release the reservoir from the priming position and release the fluid.

[0102] Therefore, in the context of the present invention, the counting mechanism preferably comprises: Rotation of at least one housing part, -Exchangeable reservoir transfer, - Activation of actuator members, At least one of the following is counted.

[0103] In a preferred embodiment, the counting mechanism counts actuations as soon as possible. For example, if the counting mechanism counts rotations of the lower housing part, said rotations are preferably counted early during the rotation. In a preferred embodiment, the counting mechanism is activated by vertical movement of a counting member which is moved by rotating the lower housing part. The counting member may be part of the blocking unit.

[0104] The counting unit may comprise indicator means for indicating the number of uses, in some embodiments the indicator means indicates the number of uses of the remaining reservoir, in other embodiments the indicator means indicates the number of uses of the reservoir.

[0105] Alternatively, it is an option that the counting mechanism is activated when the replaceable reservoir is moved from the rest position to the priming position by interaction of the blocking unit with the counting unit.

[0106] The counting unit comprises a counting mechanism as well as an actuation mechanism, which in a preferred embodiment interacts with the blocking unit, preferably with a blocking mechanism of the blocking unit.

[0107] The outcome of the interaction of the activation mechanism with the prevention unit depends on the state of the prevention unit and the counting unit. In a preferred embodiment of the invention, the interaction of the activation mechanism with the prevention unit results in one of the following: If the reservoir is replaced after a given number of uses, the interaction results in a reset of the counting unit. If the reservoir is in use and a predetermined number of uses is reached, the interaction activates an inhibition mechanism, preventing further use of the reservoir. If the reservoir is in use and the predetermined number of uses has not yet been reached, the interaction has no effect or the interaction activates a counting unit to count one use of the inhaler system.

[0108] In some embodiments, the actuation mechanism includes an actuation member. In preferred embodiments, the actuation mechanism includes a movable actuation member. The actuation member may be a gear or a pin. In preferred embodiments, the actuation member is a pin. The actuation mechanism in some embodiments is driven by a counting mechanism. In other embodiments, the actuation mechanism may be driven independently of the counting mechanism.

[0109] In some embodiments, the actuation member of the actuation mechanism interacts with the blocking mechanism and / or the counting mechanism. In some embodiments, the actuation member interacts with a movable element within the blocking mechanism. In some embodiments, the actuation member is a pin and interacts with the blocking mechanism after a predetermined number of uses. For example, the actuation member moves a movable member within the blocking mechanism to activate the blocking mechanism after a predetermined number of uses of the reservoir. In some embodiments, the actuation of said blocking mechanism is reversible. In preferred embodiments, said actuation of said blocking mechanism is irreversible.

[0110] In a preferred embodiment, an actuation member of the actuation mechanism of the counting unit enters an opening in the blocking unit to interact with the blocking mechanism when the replaceable reservoir is moved from the rest position to the priming position. The movable actuation member activates the blocking mechanism as soon as a predetermined number of uses is reached.

[0111] In some embodiments, the movable actuation member is driven by the counting mechanism. In some embodiments, the movable actuation member is moved gradually or stepwise with each actuation of the counting mechanism. In this case, the actuation member may be a pin emerging from the counting unit and interacting with the blocking unit upon movement of the reservoir. The pin may change position upon actuation of the counting unit. In this way, the position of the actuation member is controlled by the counting unit.

[0112] In a preferred embodiment, the actuation member is movable, for example by incremental movement, the position of the member being dependent on the number of uses of the replaceable reservoir.

[0113] In preferred embodiments, the actuation member is controlled by a counting mechanism. In some embodiments, the counting mechanism comprises a rotatable member having an optionally circular inclined ramp on which the actuation member is supported. In preferred embodiments, each actuation of the counting mechanism moves the rotatable member on the inclined ramp, and preferably the member is moved incrementally by sliding on a top inclined ramp.

[0114] In a preferred embodiment, the rotatable member is driven by a counting mechanism to move, preferably gradually, along the inclined surface of the ramp. The movement of the rotatable member also drives an actuation member, which moves slowly upwards in an axial or downstream direction as the rotatable member moves on the inclined surface. When the rotating member reaches the highest point of the incline, the actuation member is at its highest position.

[0115] In a particular embodiment of the invention, the actuation member is at the highest point of the ramp after said predetermined number of uses and / or is at the highest point when a new replaceable reservoir is inserted. After replacement of the reservoir, the next actuation of the inhaler system moves the actuation member to the lowest position on the ramp, preferably simultaneously resetting the counting unit. Each actuation of the inhaler system then moves the actuation member gradually, for example by a stepwise movement, to the highest position on the ramp, until it reaches the highest position after the predetermined number of uses, thereby activating the blocking mechanism of the blocking unit.

[0116] The rotatable member and the motive member may be a single part or may be two separate parts, in a preferred embodiment the rotatable member and the motive member are a single part or the motive member is connected to the rotatable member.

[0117] In a particular embodiment, the blocking mechanism comprises an opening for the actuation member. The opening allows access to the actuation member that is restricted by a blocking element after the blocking mechanism is activated. After a predetermined number of uses, the actuation member is preferably positioned towards the top end of the ramp, preventing larger movements of the reservoir when the space behind the opening is limited, as the blocking member can no longer move until the reservoir is replaced, which allows the counting mechanism to be reset.

[0118] In a particular embodiment, the blocking system comprises two members that can be connected to each other. The members have a moving configuration and a blocking configuration. The first member or fixed member comprises a hollow tube in which at least a part of the second member or moving member can move. In the moving configuration, the second member is driven by the actuation member of the counting unit during the movement of the reservoir and moves inside the hollow tube of the first member. The members may be realized as a plunger and a cam. In the moving configuration, the non-moving part maintains the same relative position with respect to the reservoir. If the actuation member is moved far enough, after a predefined number of uses, the two members interlock in a blocking configuration. In the blocking configuration, both members move to a blocking position and optionally interlock, limiting the space for the actuation member. In the blocking position, both members are fixed and cannot move.

[0119] In another embodiment, the blocking system may comprise two members: a moving member and a guide member. The guide member comprises a hollow tube that allows the moving member to move. The moving member and the guide member may be realized in the form of a plunger and a cam. The movement of the moving element is driven by an actuation member of the counting unit. The moving member or the guide member may comprise a protruding element. The blocking unit optionally comprises a recess or a corresponding protruding part that fits into a protruding element of one of the members. The moving element moves during the operation of the inhalation device system depending on the number of uses. After a certain number of uses, the protruding part of the moving or guide element moves into said recess, thereby preventing further movement of the moving element, thereby limiting the space behind the opening, allowing only partial entry of the actuation member through the opening in the case of the housing of the blocking unit, thus avoiding full entry of the actuation member.

[0120] In a further aspect, the present invention relates to a cartridge system for holding a medically active liquid for nebulization, the cartridge system being adapted to an inhaler system (10) as defined above. The replaceable cartridge system of the present invention has an upstream end and a downstream end and has an effective volume V for holding a medically active liquid. eand a connection port adapted to releasably and fluidly connect the cartridge system to a pump unit, in particular via a connection unit of a receiving unit of an inhalation device, and the blocking unit defined above is connected to the upstream end of the container part.

[0121] The cartridge system is generally defined and described in detail above, and the above details can be combined with the specific embodiments defined below.

[0122] In a further particular embodiment, the container part of the replaceable cartridge system is in the form of a dimensionally stable container fitted with a blocking unit as defined above.

[0123] The blocking unit may be permanently or removably attached. Preferably, the blocking unit is permanently attached. The blocking unit is as defined above and preferably comprises a housing which connects to the container. The housing may be of the same or different material as the container, the outer shell of the cartridge.

[0124] As noted above, the cartridge system is preferably assembled and sterilized before it is filled with medical fluid.

[0125] In a further aspect, the present invention relates to an inhalation device for use in an inhalation device system, the inhalation device comprising: a housing having a receiving unit, the receiving unit having a connection unit adapted to releasably and fluidly connect to a connection port of a replaceable reservoir, the receiving unit adapted to receive the replaceable reservoir and to fluidly connect to the replaceable reservoir; a nozzle for the atomization of a medically active liquid; a pump unit disposed within the housing, the pump unit adapted to be fluidly connected to the nozzle, the pump unit adapted to be connectable to a replaceable reservoir and adapted to transport a medically active liquid in a downstream direction from the replaceable reservoir to the nozzle, and adapted to move the replaceable reservoir from a rest position to a priming position upon priming of the pump unit; Equipped with The inhalation device a counting unit as defined above, adapted to interact with the blocking unit, and / or a blocking unit as defined above, adapted to interact with the counting unit; The present invention is characterized in that it comprises at least one of the following:

[0126] In a preferred embodiment, the inhalation device comprises a counting unit as defined above, adapted to interact with the blocking unit. In a particular embodiment, the blocking unit with which the counting unit interacts is part of the replaceable reservoir. The inhalation device may comprise a further blocking device for blocking operation, said blocking device however not interacting with the counting unit as defined above.

[0127] The present invention further relates to the following numbered embodiments:

[0128] 1. An inhalation device system (10) for administering by inhalation a medically active liquid in aerosol form, comprising an inhalation device (20) and a replaceable reservoir (30) for holding multiple doses of the medically active liquid, wherein each actuation of the inhalation device system dispenses one dose of the medically active liquid from the inhalation device; An inhalation device (20), - a housing (21) having a receiving unit (23), the receiving unit having a connection unit (24) adapted to releasably and fluidly connect to a connection port (31) of a replaceable reservoir (30), the receiving unit (24) adapted to receive the replaceable reservoir (30) and to fluidly connect to the replaceable reservoir (30); a nozzle (25) for spraying the medically active liquid; - a pump unit (40) arranged in the housing (21), adapted to be fluidly connected to the replaceable reservoir (30) and the nozzle (25) and adapted to convey (in a downstream direction) a medically active liquid from the replaceable reservoir (30) to the nozzle (25) and adapted to move the replaceable reservoir from a rest position to a priming position upon priming of the pump unit; Equipped with the inhaler system comprises a combined counting and blocking assembly comprising a counting unit for counting the number of actuations of the inhaler system (after insertion of the replaceable reservoir into the inhaler) and a blocking unit for blocking movement of the replaceable reservoir from a rest position to a priming position when a predetermined number of actuations (after insertion of the replaceable reservoir into the inhaler) is reached, the counting unit and the blocking unit are physically separated from each other when the replaceable cartridge is in a rest position and are adapted to interact with each other each time the replaceable cartridge moves from the rest position to the priming position; An inhalation device system (10).

[0129] 2. An inhalation device system as described in item 1, wherein the counting unit is attached to the housing of the inhalation device.

[0130] 3. An inhalation device system according to item 1 or 2, wherein the blocking unit is attached to a replaceable reservoir.

[0131] 4. An inhalation device system according to any one of claims 1 to 3, wherein the combined blocking and counting unit is operated without any electronic elements.

[0132] 5. An inhalation device system described in any one of items 1 to 4, wherein the housing of the inhalation device has a stationary part (comprising a pump unit, a nozzle, and a receiving unit) and a movable part (movable from a closed state and an open state and from a rest position to a priming position), and the counting unit is attached to the movable part of the housing.

[0133] 6. An inhalation device system as described in item 5, wherein the movable part of the housing is in the form of a cap that covers and closes the receiving unit of the housing.

[0134] 7. An inhalation device system according to any one of claims 1 to 6, wherein the counting unit is (permanently) attached to an inner surface of the (movable part of) the housing of the inhalation device.

[0135] 8. An inhalation device system according to any one of claims 1 to 7, wherein the counting unit is resettable (upon replacement of the replaceable reservoir).

[0136] 9. An inhalation device system according to any one of claims 1 to 8, wherein the blocking unit is firmly attached to the replaceable reservoir.

[0137] 10. An inhalation device system according to any one of claims 1 to 8, wherein the blocking unit is releasably attached to a replaceable reservoir.

[0138] 11. An inhalation device system according to any one of claims 1 to 10, wherein the replaceable reservoir is in the form of a replaceable cartridge having an upstream end and a downstream end, and the blocking unit is attached to the upstream end of the replaceable cartridge.

[0139] 12. An inhalation device system described in any one of items 1 to 11, wherein the blocking unit has a housing that accommodates the blocking mechanism.

[0140] 13. An inhalation device system as described in item 12, wherein the housing of the blocking unit is provided with an opening for physical interaction between the counting unit and the blocking mechanism.

[0141] 14. An inhalation device system as described in paragraph 13, wherein the opening of the blocking unit is located at the upstream end of the blocking unit.

[0142] 15. An inhalation device system according to any one of claims 1 to 14, wherein the counting unit comprises a counting mechanism and a starting mechanism.

[0143] 16. An inhalation device system according to any one of claims 1 to 15, wherein the activation mechanism interacts with the blocking mechanism of the blocking unit.

[0144] 17. An inhalation device system according to any one of clauses 1 to 16, wherein the activation mechanism comprises an activation member (in the form of a pin) for interacting with the blocking mechanism of the blocking unit.

[0145] 18. An inhalation device system as described in paragraph 17, wherein the actuation member of the counting unit enters an opening in the blocking unit to interact with the blocking mechanism when the replaceable reservoir moves from the rest position to the priming position.

[0146] 19. An inhalation device system according to claim 17 or 18, wherein the position of the actuation member is controlled by a counting mechanism.

[0147] 20. An inhalation device system described in any one of clauses 1 to 19, wherein the counting mechanism is operated by (physical / mechanical) interaction with the blocking unit when the replaceable reservoir moves from the rest position to the priming position.

[0148] 21. An inhaler system according to any one of clauses 1 to 20, wherein the counting mechanism comprises indexing means for indexing the number of actuations of the inhaler system (after insertion of the replaceable cartridge).

[0149] 22. An inhalation device system according to any one of clauses 1 to 21, wherein the counting mechanism comprises a rotatable member having a (circular) inclined ramp on which the actuation member is supported.

[0150] 23. An inhalation device system as described in any one of clauses 1 to 22, wherein the blocking unit is provided with a blocking member that is initially activated so as to "transition" to a blocking state when interacting with a counting mechanism after a predetermined number of actuations of the inhalation device system (after insertion of a replaceable cartridge).

[0151] 24. An inhalation device system according to any one of claims 1 to 23, wherein the blocking member of the blocking unit is moved to the blocking position when a predetermined number of actuations is reached (after insertion of the replaceable reservoir into the inhalation device).

[0152] 25. An inhalation device system (10) according to any one of claims 1 to 24, wherein the replaceable reservoir is provided in the form of a bag, in particular in the form of a cartridge having an outer (dimensionally stable) shell with an inner container for holding the medically active liquid in the form of a collapsible bag.

[0153] 26. An inhalation device system (10) described in any one of paragraphs 10 to 25, wherein the force required to remove the blocking unit from the replaceable reservoir is higher than the force required to remove the replaceable reservoir from the receiving unit (23) of the inhalation device (20).

[0154] 27. An inhalation device system (10) described in any one of items 1 to 26, wherein the replaceable reservoir with the blocking unit has a cylindrical shape with a central longitudinal axis (A) connecting the connection port (32) of the replaceable reservoir (30) located at the downstream end of the replaceable reservoir (31) with the upstream end of the blocking unit attached to the upstream end of the replaceable reservoir.

[0155] 28. An inhalation device system (10) described in any one of items 1 to 27, wherein the replaceable reservoir (31) has an upstream end (34) and a downstream end (35), the connection port (32) is located at the downstream end (34) of the replaceable reservoir (31), and the blocking unit is attached to the upstream end (35) of the replaceable reservoir.

[0156] 29. An inhalation device system (10) according to any one of claims 1 to 28, wherein the blocking unit (33) is attached to the outer surface of the replaceable reservoir (31) by a pressure-fit or form-fit connection.

[0157] 30. An inhalation device system (10) according to any one of claims 1 to 29, wherein the blocking unit (33) has substantially the same cross-sectional diameter as the replaceable reservoir (31).

[0158] 31. An inhalation device system (10) according to any one of claims 1 to 30, wherein the blocking unit (33) and the replaceable reservoir (30) have a circular cross section.

[0159] 32. An inhalation device system (10) described in any one of items 1 to 31, wherein the blocking unit (33) (the housing thereof) has an opening (37) at its downstream end, the opening having a diameter corresponding to the diameter (outer diameter) of the upstream end (34) of the replaceable reservoir.

[0160] 33. An inhalation device system (10) as described in any one of paragraphs 1 to 32, wherein the replaceable reservoir (31) and blocking unit (33) are assembled and sterilized prior to filling the cartridge system (30) with the medically active liquid.

[0161] 34. The replaceable reservoir (30) has a usable volume V selected within the range of about 0.1 to about 15 mL. e Item 34. An inhalation device system (10) according to any one of items 1 to 33, comprising:

[0162] 35. The pump unit (40) of the suction device (20) an upstream end fluidly connected to a replaceable reservoir (30); a downstream end fluidly connected to a nozzle (25); Equipped with The pump unit is (i) a riser pipe (43) having an upstream end, -It acts as a piston in the pump unit, - rigidly fixed to the side of the housing (21) facing the user so as to be immovable relative to the housing (21); A riser pipe (43); (ii) a hollow cylinder (41) located upstream of a riser pipe (44), the upstream end of the riser pipe (43) being inserted into the cylinder (41) so that the cylinder (41) is longitudinally movable on the riser pipe (43); Item 35. The inhalation device system (10) according to any one of items 1 to 34, further comprising:

[0163] 36. The pump unit (40) (iii) lockable means (46) for storing potential energy when locked and releasing the stored energy when unlocked, the means (46) being disposed outside of and mechanically coupled to the cylinder (41) such that unlocking the means (46) propels longitudinal movement of the cylinder (41) toward the downstream end of the pump unit; Item 36. An inhalation device system (10) according to item 35, comprising:

[0164] 37. An inhalation device system according to any one of claims 1 to 36, wherein the inhalation device is a handheld inhalation device.

[0165] 38. An inhalation device system according to any one of the preceding claims, wherein the inhalation device is a soft mist inhaler having at least one impingement nozzle.

[0166] 39. An inhalation device system as described in paragraph 38, wherein at least one impingement nozzle has at least two channels for ejecting at least two jets of medically active liquid, and the at least two liquid channels are oriented such that the trajectories of the at least two jets intersect at at least one impingement point.

[0167] 40. An inhalation device system according to any one of the preceding claims, wherein the inhalation device system and / or the medically active liquid does not contain a propellant, such as a hydrogen fluoride (HFC) propellant.

[0168] 41. A replaceable cartridge system (30) for holding a medically active liquid for nebulization, the replaceable cartridge system (30) being adapted for use in an inhalation device system (10) according to any one of paragraphs 1 to 40, the effective volume V for holding a medically active liquid. e and a connection port adapted to releasably and fluidly connect the cartridge system to a pump unit, in particular via a connection unit of a receiving unit of an inhalation device, wherein a blocking unit is connected to the upstream end of the container portion. Detailed Description of the Drawings

[0169] The invention will now be further explained with reference to the drawings, which show illustrative but non-limiting embodiments of the invention.

[0170] 1 shows a prior art inhalation device system (10) comprising an inhalation device (20) and a replaceable reservoir in the form of a cartridge system (30) (different elements of the cartridge system are not shown) inserted into the inhalation device. The inhalation device (20) comprises a housing (21) having a lower part (22) which can be removed from the inhalation device (20) to open the housing (21) and allow access to a receiving unit (23) into which the replaceable cartridge system (30) can be inserted. The receiving unit (23) further comprises a connection unit (24) adapted to releasably and fluidly connect to a connection port (32) of the replaceable reservoir.

[0171] The inhalation device (20) further comprises a nozzle (25) located at the downstream end of the inhalation device for spraying the medically active liquid. The inhalation device further comprises a pump unit (40) disposed within the housing (21). As explained in detail above, the pump unit is fluidly connected to the reservoir (via the connection unit (24) of the receiving unit (23)) and to the nozzle (25) for pumping the medically active liquid in a downstream direction from the reservoir (30) to the nozzle (25).

[0172] The pump unit (40) has an upstream end (41) fluidly connected to the replaceable reservoir (30) and a downstream end (42) fluidly connected to the nozzle (25), and the pump unit (40) further comprises: (i) a riser pipe (43) having an upstream end (44), the riser pipe (43) acting as a piston within the pump unit (40), the riser pipe (43) being rigidly fixed to the user-facing (downstream) side of the housing (21) such that the riser pipe (43) is immovable relative to the housing (21); and (ii) a hollow cylinder (45) located upstream of the riser pipe (43), the upstream end of the riser pipe (44) being inserted into the cylinder (45) such that the cylinder (45) is longitudinally movable on the riser pipe (43).

[0173] As also shown in FIG. 1 , the pump unit (40) (iii) includes lockable means (46) for storing potential energy when locked and releasing the stored energy when unlocked, the means (46) being disposed outside of and mechanically coupled to the cylinder (45) such that unlocking the means (46) propels the cylinder (45) in the longitudinal direction toward the downstream end of the pump unit (42).

[0174] 2 shows an exemplary embodiment of an inhalation device system (10) according to the present invention in a fully assembled state. The inhalation device system comprises an inhalation device (20) with an inserted replaceable reservoir in the form of a cartridge system (30). In this particular embodiment, the inhalation device comprises a counting unit (32) and the cartridge system of the reservoir comprises a blocking unit (33).

[0175] The counting unit is part of a lower housing part 22 of the inhalation device 20. The lower housing part 22 can be removably removed or opened, for example by means of a hinge (not shown).

[0176] The cartridge system (30) comprises a blocking unit (33) adapted to interact with the counting unit (32).

[0177] 3 shows a schematic view of the lower part of the housing (22) without the upper housing part. The counting unit (32) is arranged on the removable base (27) of the inhalation device system. The replaceable cartridge system (30) comprises a container part (31) and a blocking unit (33). The blocking unit (33) is physically separated from the counting unit (32) and comprises a counting member (65) capable of interacting with the counting unit.

[0178] Figures 4A-4C show an exemplary embodiment of a counting unit (32) according to the present invention. Figure 4A shows a view of the inside of the housing of the counting unit (51) showing the counting unit in an assembled state. Figure 4B shows a detailed view of the components of the counting unit, and Figure 4C shows the counting unit assembled without the inhalation device.

[0179] The counting unit (32) comprises a housing (51) in which a counting mechanism is disposed. The counting mechanism includes a movable sley (54) which drives a counting gear (53) to move an indicator member (55) having surface teeth and an inclined ramp (58). Outside the indicator member (55) there is an indexing means (56) for indicating the number of uses of the inhaler system. The counting unit further comprises an actuation member (52) movable to an increasing height on the inclined ramp based on a position on the inclined ramp. The actuation member is adapted to interact with the blocking mechanism.

[0180] Figure 5 shows an overview of an embodiment of a cartridge system according to the invention including a blocking unit according to the invention. Figure 5A shows the receptacle part (31) of the cartridge system which can be connected to a housing of a blocking unit (61) which includes a counting member (65) for interacting with a counting unit. The blocking system comprises a plunger (62) and a cam (63) which can interact and are held by a spring (64) mechanism.

[0181] FIG. 5B shows the inside of the housing of the blocking unit (62), which includes protrusions (66) that limit the movement of the plunger (62) and cam (63) depending on the state of the blocking unit.

[0182] Figures 6A-6C show an embodiment of the counting mechanism and possible interactions between the blocking unit and the counting unit. Figure 6A shows the inhalation device system in a rest position. The counting member of the blocking system is above the opening of the counting unit and does not interact with it. The movable sley (54) of the counting mechanism is in a neutral position. The position of the actuation member (52) on the inclined ramp (58) of the indicator member (55) depends on the number of previous uses. Figure 6A shows the initial stage, just after inserting a new replaceable reservoir, where the actuation member (62) is in a low position on the inclined ramp.

[0183] Figure 6B shows the inhaler system in a priming position. The counting member (65) of the blocking unit enters an opening (57) in the counting unit, thereby moving the movable sley (54). The movement of the movable sley drives the counting gear (53), which moves the indicator member (55), advancing the indexing means (56) and causing the actuation member (52) to rise up the inclined ramp. Figure 6B further shows that the actuation member does not interact with the blocking unit until a predetermined number of uses has been reached.

[0184] 6C shows the counting unit and the blocking unit interacting after a predetermined number of uses. The actuation member (52) has moved on an inclined ramp (58) and can interact with the blocking unit by interacting with the plunger (62).

[0185] 7A-7D show another embodiment of the counting mechanism. The counting mechanism comprises an actuation member (52) disposed on an inclined ramp (58) that interacts with a clocking mechanism after a predetermined number of actuations.

[0186] Figure 7A shows the counting mechanism through a cross section within the housing (51), Figure 7B shows a cross section of the counting mechanism, and Figure 7C shows the inner portion of the housing (51) and the actuation member (52) positioned on an inclined ramp (58).

[0187] FIG. 7D shows the parts of the counting mechanism separately.

[0188] The alternative counting mechanism comprises a drive member (57) instead of the movable sley (54). The drive member comprises a helical guide thread (70) and radially arranged gear teeth (69). The helical guide thread (69) interacts with a guide member (68) arranged in the housing (51) of the counting unit. The drive member is movable and can be returned to its original position by a spring (64).

[0189] To activate the counting unit, the counting member (55) of the blocking unit enters the opening (57) in the housing (51) and moves the drive member (67). The drive member is guided by the guide member (68) to move the gear (53) and thus the indexing means (56), which in turn moves the actuation member along the inclined ramp (58) until it interacts with the blocking unit. In some embodiments, it is also possible for the drive member to move the indexing means directly.

[0190] Figures 8A-8C show one embodiment of the blocking mechanism. Figure 8A shows the blocking mechanism in an initial position where the cam (63) is held in place by a protrusion (66) on the inside of the housing of the blocking unit (61). The plunger (62) is movable inside the cam (63) and can be actuated by an actuating member (52) of the counting unit. The cam and plunger are held in place by a spring (not shown).

[0191] Figures 8B and 8C show the activation of the blocking mechanism. After activation by the actuation member (52) of the counting unit, the plunger (62) moves and activates the cam (63), moving it away from the protrusion (66) (Figure 8B). Due to a spring mechanism (not shown), the cam (62) moves along the protrusion (66) to a blocking position (Figure 8C), which prevents further movement of the plunger (62) and the cam (63). In this case, the actuation member (52) of the counting unit prevents further movement of the cartridge, and thus prevents further use of the cartridge. [Explanation of symbols]

[0192] 10. Inhalation Device System 20 Inhaler 21 Housing 22 Lower part of housing 23 Reception Unit 24 Connection Unit 25 Nozzles 26 Cap 27 Removable Base 30 Interchangeable Cartridge System 31 Container section 32 Counting Unit 33 Blocking Unit 40 Pump unit 41 Upstream end of pump unit 42 Downstream end of pump unit 43 Riser Pipe 44 Upstream end of riser pipe 45 Hollow cylinder of pump unit 46 Lockable means for storing potential energy 51 Counting unit housing 52 Starting member 53 Gear 54 Movable Slay 55 Indicator member with inclined ramp and surface teeth 56 Indexing means 57 Aperture 58 Inclined Ramp 61 Blocking Unit Housing 62 Plunger 63 Cam 64 Spring 65 Counting elements 66 Protrusion 67 Driving member 68 Guide member 69 gear teeth 70 helical guide threads

Claims

1. An inhalation device system (10) for the inhalation administration of a medically active liquid in spray form, the inhalation device system comprising an inhalation device (20) and a replaceable reservoir (30) for holding a plurality of doses of the medically active liquid, wherein one dose of the medically active liquid is dispensed from the inhalation device with each actuation of the inhalation device system, wherein the inhalation device (20) comprises - a housing (21) having a receiving unit (23), the receiving unit having a connection unit (24) adapted to be releasably and fluidly connected to a connection port (31) of the replaceable reservoir (30), the receiving unit (24) being adapted to receive the replaceable reservoir (30) and to be in fluid connection with the replaceable reservoir (30), a housing (21); - a nozzle (25) for spraying the medically active liquid; - a pump unit (40) arranged within the housing (21), the pump unit being fluidly connected to the replaceable reservoir (30) and the nozzle (25) and being adapted to convey the medically active liquid from the replaceable reservoir (30) to the nozzle (25), the pump unit being adapted to move the replaceable reservoir from a rest position to a priming position during priming of the pump unit, a pump unit (40); in an inhalation device system (10), the inhalation device system comprises a combined counting and blocking assembly comprising a counting unit for counting the number of actuations of the inhalation device system and a blocking unit for preventing the movement of the replaceable reservoir from the rest position to the priming position when a predetermined number of actuations is reached, the counting unit and the blocking unit being physically separated from each other when the replaceable cartridge is in the rest position and interacting with each other each time the replaceable cartridge moves from the rest position to the priming position, the blocking unit being attached to the replaceable reservoir and the counting unit being attached to the housing of the inhalation device, or the counting unit being attached to the replaceable reservoir and the blocking unit being attached to the housing of the inhalation device, characterized in that it is an inhalation device system (10).

2. The inhalation device system according to claim 1, wherein the counting unit is attached to the housing of the inhalation device and the blocking unit is attached to the replaceable reservoir.

3. The inhalation device system according to claim 1, wherein the replaceable reservoir is in the form of a replaceable cartridge having an upstream end and a downstream end, and the blocking unit is attached to the upstream end of the replaceable cartridge.

4. The inhalation device system according to claim 1, wherein the blocking unit has a housing that houses a blocking mechanism.

5. The inhalation device system according to claim 4, wherein the housing of the blocking unit has an opening for interaction between the counting unit and the blocking mechanism.

6. The inhalation device system according to claim 4, wherein the counting unit includes a counting mechanism and an activation mechanism.

7. The inhalation device system according to claim 6, wherein the activation mechanism interacts with the blocking mechanism of the blocking unit.

8. The inhalation device system according to claim 7, wherein the activation mechanism includes an activation member for interacting with the blocking mechanism of the blocking unit, the activation member is movable, and the position of the activation member changes with each operation of the inhalation device system.

9. The inhalation device system according to claim 8, wherein the activation member moves gradually or stepwise with each operation.

10. The activation member of the blocking unit of the inhalation device system according to claim 8 enters the opening of the blocking unit to interact with the blocking mechanism when the replaceable reservoir moves from the rest position to the priming position.

11. The inhalation device system according to claim 1, wherein the counting mechanism is operated by interaction with the blocking unit when the replaceable reservoir moves from the rest position to the priming position.

12. The inhalation device system according to claim 6, wherein the blocking unit includes a blocking mechanism that limits the space for the activation member after a predetermined number of uses so that the replaceable reservoir can no longer move to the priming position.

13. A replaceable cartridge system for an inhalation device system comprising the composite counting and blocking assembly according to any one of claims 1 to 12 for holding a medicinally active liquid for spraying, the replaceable cartridge system being adapted for use in an inhalation device system according to any one of claims 1 to 12, wherein the cartridge system has an effective volume V for holding a medicinally active liquid ｅ comprising a container part having, and a connection port adapted to releasably and fluidly connect the cartridge system to the pump unit, in particular via the connection unit of the receiving unit of the inhalation device, the cartridge system comprising a blocking unit adapted to interact with a counting unit of an inhalation device comprising the composite counting and blocking assembly according to any one of claims 1 to 12. A replaceable cartridge system.

14. An inhalation device for an inhalation device system comprising a combined counting and blocking assembly according to any one of claims 1 to 12, wherein the inhalation device is - A housing having a receiving unit, the receiving unit having a connection unit adapted to be releasably and fluidly connected to the connection port of the replaceable reservoir, the receiving unit being adapted to receive the replaceable reservoir and be fluidly connected to the replaceable reservoir, a housing; - A nozzle for spraying the medically active liquid; - A pump unit disposed within the housing, the pump unit being fluidly connected to the nozzle and connectable to a replaceable reservoir, the pump unit being adapted to convey the medically active liquid downstream from the replaceable reservoir to the nozzle, and the pump unit being adapted to move the replaceable reservoir from a rest position to a priming position during priming of the pump unit, a pump unit; In an inhalation device comprising: - A counting unit adapted to interact with the blocking unit of the composite counting and blocking assembly according to any one of claims 1 to 12, and / or - A blocking unit adapted to interact with the counting unit of the composite counting and blocking assembly according to any one of claims 1 to 12, An inhalation device, characterized in that it comprises at least one of the above.

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