Inhalation device system with a counting and blocking assembly

Abstract

and being adapted to move the exchangeable reservoir from a resting position to a primed position upon priming of the pumping 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 (following the insertion of the exchangeable reservoir into the inhalation device) and a blocking unit for blocking the movement of the exchangeable reservoir from the resting position to the primed position when a defined number of actuations (following the insertion of the exchangeable reservoir into the inhalation device) is reached, wherein the counting unit and the blocking unit are physically separated from each other when the exchangeable reservoir is in the resting position and adapted to interact with each other upon each movement of the exchangeable reservoir from the resting position to the primed position.

Description

[Technical Field]

[0001] This invention relates to the field of inhalation devices for medically active liquids. Specifically, this invention relates to an inhalation device system comprising an inhalation device and a replaceable reservoir for holding a medically active liquid, wherein the inhalation device system includes a combined counting and blocking assembly. [Previous Technology]

[0002] Nebulizers or other aerosol generators for liquids are well known in the art. Such devices are used in medicine and therapy. They serve as inhalation devices for administering active ingredients in the form of aerosols (i.e., small droplets embedded with gas). Such inhalation devices are known, for example, from publication EP 0 627 230 B1. The basic components of this inhalation device are a reservoir containing the liquid to be aerosolized; a pumping device for generating sufficiently high pressure to nebulize the liquid; and an atomizing device in the form of a nozzle. The liquid is drawn from the reservoir in discrete amounts (i.e., discontinuously) and supplied to the nozzle via the pumping device. The pumping device operates without a propellant and mechanically generates pressure.

[0003] A known embodiment of such an inhalation device is proposed, for example, in publication WO 91 / 14468 A1. In this device, pressure in a pump chamber connected to the housing is generated by the movement of a movable hollow piston. This piston is movably arranged within a stationary cylinder or pump chamber. An inlet fluid located upstream of the hollow piston is connected to the interior of a reservoir (i.e., the reservoir tube section). A tip located downstream of the hollow piston leads to the pump chamber. Furthermore, a check valve preventing liquid backflow into the reservoir is arranged within the tip of the piston.

[0004] Another inhalation device is known from WO 2018 / 197730 A1. The handheld inhalation device disclosed therein includes a housing having a user-facing side; an impact nozzle for generating an atomized aerosol through the collision of at least two liquid jets, the nozzle being securely fixed to the user-facing side of the housing so that it cannot move relative to the housing; a fluid reservoir disposed within the housing; and a pumping unit disposed within the housing, the pumping unit having an upstream end fluidly connected to the fluid reservoir and a downstream end fluidly connected to the nozzle. The pumping unit is adapted to pump fluid from the fluid reservoir to the nozzle, and it includes a riser pipe adapted to function as a piston in the pumping unit and securely fixed to the user-facing side of the housing so that it cannot move relative to the housing.

[0005] WO 2017 / 076938 A1 discloses a system having an atomizer, a container containing fluid, and an indicator device for such atomizer. The system is used to indicate the number of containers that have been used with the atomizer or can still be used with it. The indicator device indicates the number of uses performed or still possible with the current container.

[0006] WO 2019 / 016409 A2 describes an atomizer for atomizing a liquid from a container and such a container. The atomizer includes a fluid pump for dispensing liquid from the container in doses and pressurizing the agents used for atomization. The container includes an air pump with a piston / cylinder device to pressurize the liquid in the container to facilitate dispensing the liquid from the container. A control valve limits the air pressure acting on the liquid.

[0007] Known inhalation devices or inhalation device systems typically utilize a counting and blocking system that usually counts the number of times the container is activated and blocks further use of the atomizer until the container is replaced. This combined system is usually attached to the container and replaced along with it, making the production of the container more expensive.

[0008] The object of the present invention is to provide an inhalation system with a novel combined counting and blocking component, which allows for greater flexibility when used in an inhalation device or inhalation device system. [Summary of the Invention]

[0009] In a first aspect, the present invention relates to an inhalation device system for inhalation administration of a medically active liquid in atomized form, the system comprising an inhalation device (20) and a replaceable reservoir (30) for holding multiple doses of the medically active liquid, wherein each time the inhalation device system is actuated, a dose of the medically active liquid is dispensed from the inhalation device, wherein the inhalation device (20) comprises: - a housing (21) having a receiving unit (23) having a connecting 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 and fluidly connect to the replaceable reservoir (30); - a nozzle (25) for atomizing the medically active liquid; and - A pumping unit (40), disposed within the housing (21) and adapted to be fluidly connected to the replaceable reservoir (30) and the nozzle (25), and adapted to deliver the medically active liquid from the replaceable reservoir (30) (downstream) to the nozzle (25), and adapted to move the replaceable reservoir from a rest position to an activated position when the pumping unit is activated, wherein the inhalation device system includes a combined counting and blocking assembly comprising: a counting unit for counting the number of actuations of the inhalation device system (after the replaceable reservoir is inserted into the inhalation device); and a blocking unit for preventing the replaceable reservoir from moving from the rest position to the activated position when a predetermined number of actuations is reached (after the replaceable reservoir is inserted 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 are adapted to interact each time the replaceable reservoir moves from the rest position to the activated position.

Implementation Method

[0011] The present invention provides an inhalation device system for inhalation administration of a medically active liquid in atomized form, the system comprising an inhalation device (20) and a replaceable reservoir (30) for holding multiple doses of the medically active liquid, wherein each time the inhalation device system is actuated, a dose of the medically active liquid is dispensed from the inhalation device, wherein the inhalation device (20) comprises: - a housing (21) having a receiving unit (23) having a connecting 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 and fluidly connect to the replaceable reservoir (30); - a nozzle (25) for atomizing the medically active liquid; and - A pumping unit (40), disposed within the housing (21) and adapted to be fluidly connected to the replaceable reservoir (30) and the nozzle (25), and adapted to deliver the medically active liquid from the replaceable reservoir (30) (downstream) to the nozzle (25), and adapted to move the replaceable reservoir from a rest position to an activated position when the pumping unit is activated, wherein the inhalation device system includes a combined counting and blocking assembly comprising: a counting unit for counting the number of actuations of the inhalation device system (after the replaceable reservoir is inserted into the inhalation device); and a blocking unit for preventing the replaceable reservoir from moving from the rest position to the activated position when a predetermined number of actuations is reached (after the replaceable reservoir is inserted 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 are adapted to interact each time the replaceable reservoir moves from the rest position to the activated position.

[0012] The inhalation device system according to the invention is suitable for the inhalation administration of a nebulized medically active liquid, wherein the term "medically active liquid" as used herein refers to a liquid compound or composition of a compound or composition that is pharmacologically active and capable of improving or preventing symptoms associated with a disease, disorder, or condition, particularly those of a respiratory disease, disorder, or condition (e.g., lung disease, disorder, or condition in a subject, particularly a warm-blooded animal or human, especially a human). Specific examples of such diseases, disorders, or conditions include, but are not limited to, lung diseases or conditions such as asthma and / or chronic obstructive pulmonary disease (COPD), especially COPD, or interstitial lung diseases affecting the interstitium of the lungs and lung tissue (e.g., tissues associated with the airways and / or alveoli), such as pulmonary fibrosis, such as idiopathic pulmonary fibrosis (IPF), interstitial pneumonia, or sarcoidosis.

[0013] Furthermore, as used herein, the term "inhalation administration" refers to a route of administration in which a medically active liquid is delivered to the respiratory system, particularly the lower respiratory system, such as the lungs of a subject, by inhalation of an air stream or other carrier gas stream containing a medically active liquid in a nebulized or aerosolized form. The terms "nebulized," "aerosolized," or "atomized" as used synonymously herein refer to the state of the medically active liquid, wherein it exists in the form of an aerosol having at least two phases: a continuous gaseous phase, such as air or another carrier gas, comprising 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 solution, dispersion, suspension, or emulsion. In a specific implementation, the aerosol has inhalable particles or droplets, preferably having a mass median aerodynamic diameter (measured by laser diffraction) of no more than about 10 μm, particularly no more than about 7 μm, or no more than about 5 μm.

[0014] In specific embodiments, the term "medical active liquid" as used herein refers to a medical active liquid in the form of a pharmaceutical composition containing at least one active pharmaceutical ingredient (API), and more specifically, at least one inhalable active pharmaceutical ingredient. More specifically, for example, such at least one inhalable active pharmaceutical ingredient may be selected from long-acting muscarinic antagonists (LAMA), long-acting beta-agonists (LABA), inhalable corticosteroids (ICS), analgesics, and antidiabetic drugs, alone or in combination with each other.

[0015] Examples of long-acting muscarinic antagonists (LAMA) include, but are not limited to, alidinium bromide, glycopyrronium salts such as glycopyrronium bromide, revenacin, tiotropium salts such as tiotropium bromide, umeclidinium bromide, oxitropium bromide, flutropium bromide, ipratropium bromide, trospium chloride, and tolterodine.

[0016] Examples of long-acting β-agonists (LABAs) include, but are not limited to, albuterol, artoformoterol, bambuterol, bitolterol, broxaterol, carbuterol, clenbuterol, fenoterol, formoterol, hexoprenaline, ibuterol, indacaterol, indacterol, isoetharine, isoprenaline, and levosalbutanol. Vosalbutamol), Mabuterol, Meluadrine, Metaproterenol, Olodaterol, Orciprenaline, Pirbuterol, Procaterol, Reproterol, Rimitelol, Ritodrine, Salmeterol, Salmefamol, Soterenot, Sulphonterol, Tiaramde, Terbutaline, Terbuterol.

[0017] Examples of inhalable corticosteroids (ICS) include, but are not limited to, prednisolone, prednisone, butixocort propionate, flunisolide, beclomethasone, triamcinolone, budesonide, fluticasone, mometasone, ciclesonide, rofleponide, dexamethasone, etiprednol-dichloroacetat, deflazacort, etiprednol, loteprednol, RPR-106541, NS-126, and ST-26.

[0018] In addition, 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, such as acetylsalicylic acid), or cannabinoids (e.g., tetrahydrocannabinol), or antidiabetic drugs, such as insulin.

[0019] A medical active liquid or liquid pharmaceutical composition that can be nebulized or aerosolized by the inhalation device system of the present invention may contain at least one active pharmaceutical ingredient as described above, but may also contain a mixture of two or more active pharmaceutical ingredients that can be administered by inhalation.

[0020] The medically active liquid or pharmaceutical composition that can be atomized by the inhalation device system according to the invention is preferably formulated as a composition suitable for inhalation, in other words, a composition that can be nebulized or aerosolized for inhalation and is physiologically acceptable for the subject to inhalation.

[0021] The medically active liquid or pharmaceutical composition that can be administered through the inhalation device system of the present invention or that can be contained in a corresponding replaceable reservoir can be in the form of a dispersion, such as a suspension having a liquid continuous phase and a solid dispersed phase, or in the form of a solution.

[0022] In other embodiments, the medically active liquid or pharmaceutical composition described above may optionally contain one or more physiologically acceptable excipients suitable for inhalation. Excipients that can be characterized in the composition may include, but are not limited to, one or more buffers to adjust or control the pH of the solution, salt, taste-masking agent, surfactant, lipid, antioxidant, and cosolvent (which may be used to enhance or improve solubility, such as ethanol or ethylene glycol).

[0023] In a specific embodiment, the medical active liquid described above may be substantially free of propellants, such as hydrofluorocarbon (HFA) propellants.

[0024] In other specific embodiments, the medically active liquid described above may be an aqueous solution in which one or more of the above-described active pharmaceutical ingredients are dissolved and solubilized in a liquid carrier solution containing water. Such aqueous solutions may also optionally contain one or more excipients as described above.

[0025] The inhalation device system of the present invention includes an inhalation device and a replaceable reservoir for holding a medically active liquid. In a specific embodiment, the inhalation device of the inhalation device system of the present invention may be a handheld device, or in other words, a mobile device that can be easily held and used with one hand and is suitable for delivering atomized medically active liquid for inhalation therapy as described above. For suitability for inhalation therapy, the device must be able to release a medically active aerosol with an inhalable particle size, i.e., a particle size small enough to be absorbed by the lungs of a patient or user, with inhalable particles within the aforementioned range. In this respect, the inhalation device differs significantly from, for example, devices disclosed in US 2004 / 0068222 A1 that release sprays for oral or nasal administration.

[0026] The inhalation device of this system includes a housing that defines an outer casing of the inhalation device, particularly an outer casing for receiving and / or connecting other components of the inhalation device. The housing may have a user-facing side accessible to the user of the inhalation device, particularly for inhalation administration as described above. In a specific embodiment, the user-facing side may be a nozzle that can be introduced into the user's mouth, particularly for the inhalation or administration of atomized medical active liquids.

[0027] Furthermore, the housing may have a lower portion, preferably located upstream of the inhalation device, which may be movable, opened, or detached and at least partially removed to open the housing and allow access to the receiving unit into which a replaceable reservoir can be inserted. With respect to the inhalation device, inhalation device system, cartridge system, or other components of the present invention, the term “upstream” as used herein refers to the direction or location in which the delivery of the medically active liquid by the inhalation device begins during operation. Conversely, the term “downstream” as used herein refers to the opposite direction or location to which the delivery of the medically active liquid by the inhalation device arrives during operation.

[0028] The lower portion of the housing is preferably movable to provide access to the receiving unit defined below. In one embodiment, this corresponds to a movable component that provides access to the receiving unit. In some embodiments, the movable component is permanently attached to the housing; in certain embodiments, the movable component is attached to the housing via, for example, a hinge. In other embodiments, the movable component is detachable from the housing.

[0029] In some embodiments, the housing of the inhalation device has a fixed portion including a pumping unit, a nozzle and a receiving unit and at least one movable portion, wherein the movable portion can be moved from a closed state and an open state and / or from a stationary position to an activated position.

[0030] The inhalation device, or more specifically, the housing of the inhalation device of the present invention includes a receiving unit adapted to receive a replaceable reservoir or cartridge system as described in further detail below. The receiving unit has a connecting unit adapted to be releasably and fluidly connected to a connection port of the replaceable reservoir. The term "fluid connection" as used herein refers to establishing or being able to establish a connection with respect to two components, preferably an airtight and / or liquidtight connection, to allow fluid (e.g., gas or liquid) to transfer from one component to another, preferably in such a manner as to allow complete transfer of fluid from one component to another.

[0031] In some embodiments, the movable part of the housing is in the form of a cover that covers and closes the receiving unit of the housing.

[0032] As described in further detail below, the receiving unit of the housing is adapted to receive, or in some embodiments, fully receive and fluidly connect to the replaceable reservoir. This means, particularly with respect to the term "fully receive" as used herein, that the replaceable reservoir can be fully introduced into the receiving unit of the housing such that the receiving unit and the housing can completely enclose or encase the replaceable reservoir, preferably in such a manner that the surface of the replaceable reservoir is completely surrounded by the housing of the suction device when introduced into the receiving unit.

[0033] The inhalation device of the system of the present invention further includes a nozzle for atomizing the medically active liquid. Those skilled in the art are familiar with various types of nozzles suitable for nebulization, aerosolization, or atomization of the medically active liquid applied by the system of the present invention, such as impingement nozzles, swirl nozzles, orifice nozzles, surface impact nozzles, or multi-fluid nozzles. However, in a specific embodiment, the nozzle of the inhalation device of the present invention is impingement type. This means that the nozzle is adapted to release at least two liquid jets that are guided to collide and break down into small aerosol droplets. In a specific embodiment, the nozzle is securely fixed to the housing, particularly to the user-facing side of the housing of the inhalation device, such that it is stationary or immovable relative to the housing or at least relative to the user-facing (e.g., patient-facing) side of the housing, or more specifically, the nozzle is introduced into the user's mouth during use of the device.

[0034] The inhalation device of the system of the present invention further includes a pumping unit disposed within the housing of the inhalation device. The pumping unit is adapted to be fluidly connected to a reservoir, particularly through a connection unit of the receiving unit. In a specific embodiment, the pumping unit is fluidly connected to the reservoir through the connection unit of the receiving unit. Furthermore, the pumping unit is also adapted to be fluidly connected to a nozzle, or, in a specific embodiment, connected to a nozzle, and further adapted to deliver (or in other words, pump) the medically active liquid from the reservoir to the nozzle in a downstream direction.

[0035] The pumping unit included in the inhalation device of the present invention, in a specific embodiment, is adapted and suitable for delivering atomized medical active liquid in a discontinuous manner (i.e., in the form of discrete units), wherein each pumping loop delivers one unit. In this respect, the inhalation device differs from known nebulizers, such as jet nebulizers, ultrasonic nebulizers, vibrating mesh nebulizers, or electrohydrodynamic nebulizers, which typically generate and deliver atomized aerosol continuously over time periods of seconds to minutes, requiring multiple consecutive breathing actions for the aerosol to be inhaled by the patient or user. In contrast, the inhalation device of the present invention is adapted to generate and release aerosol in discrete units, wherein each unit corresponds to the amount (i.e., volume) of fluid (i.e., medical active liquid) pumped by the pumping unit to the nozzle in one pumping loop, which is directly atomized at the nozzle and delivered to the user or patient. Conversely, the amount of liquid pumped by the pumping unit in one pumping loop determines the amount of pharmacologically active agent received by the patient with each administration. Therefore, accurate, reliable, and reproducible operation of the pump unit is crucial for achieving the desired therapeutic effect. Such inhalation devices exhibiting high precision and reproducibility, particularly in conjunction with the pump unit described in further detail below, are well known to those skilled in the art and are described in WO 2018 / 197730 A1 (the disclosure of which is incorporated herein by reference in its entirety). However, it should be noted that the specific design of the pump unit can vary, and additional pump units, such as those described in US 2012 / 0090603 A1 (the entire contents of which are incorporated herein by reference), can also be used in the inhalation device of the present invention.

[0036] In a specific embodiment, the pumping unit may also be arranged within a housing and may be adapted to function as a piston pump, also known as a plunger pump, wherein the riser serves as a piston or plunger that can move longitudinally within the air cylinder. The pumping unit may have an upstream end fluidly connected to a replaceable reservoir and a downstream end fluidly connected to a nozzle. In other specific embodiments, the pumping unit may include a riser adapted to function as a piston in the pumping unit, an air cylinder, and a lockable device for storing potential energy. The lockable device (e.g., a coil spring or other elastic element) is capable of storing potential energy when locked and is adapted to release the stored energy when unlocked. The lockable device may be arranged outside the air cylinder and mechanically coupled to the air cylinder such that unlocking the device causes a longitudinally advancing movement of the cylinder toward the downstream end of the pumping unit. The internal portion of such air cylinder (in which the upstream end of the riser moves) forms a pump chamber having a variable volume depending on the position of the riser relative to the cylinder.

[0037] Generally, if the lockable device for storing potential energy is locked and stores potential energy, the inhalation device system is in the activated state; in the activated state, the reservoir is in the activated position. If the lockable device for storing potential energy is released and unlocked, the inhalation device system is in the stationary state, and the replaceable reservoir is in the stationary position.

[0038] The air cylinder providing the pump chamber can be fluidly connected to a replaceable reservoir, or more specifically, directly or indirectly to a connection port of the replaceable reservoir, for example, through an optional reservoir tube (or reservoir tube segment). Similarly, the riser can be fluidly connected directly or indirectly to the nozzle in a liquid-tight manner at its downstream or external end, the internal (upstream) end of the riser facing the reservoir being housed in the air cylinder.

[0039] In this document, the term "hollow cylinder" refers to a hollow component or member, including one with an internal cavity having a cylindrical shape, or a component or member including a portion having a cylindrical space. In other words (this also applies to other types of piston pumps), it is not required that the external shape of the corresponding component or member be cylindrical. Furthermore, the term "hollow cylinder" does not preclude the operational state of the corresponding component or member in which the "hollow" space can be filled with material (e.g., a liquid to be atomized).

[0040] As used herein, longitudinal motion is the motion along the main shaft of the air cylinder, while propulsion motion is the motion of the component in the downstream (or forward) direction.

[0041] In a specific embodiment, the riser of the pumping unit of the inhalation device of the present invention can be arranged downstream of the cylinder and can be securely fixed to the user-facing side of the housing, such that it is stationary relative to the housing or at least relative to the user-facing portion of the housing. For the avoidance of doubt, the term "securely fixed" means fixed directly or indirectly (i.e., through one or more connecting members) to prevent relative movement between the components. Since the nozzle is preferably also stationary relative to the housing or a corresponding part of the housing, the riser is also preferably stationary relative to the nozzle, and in these embodiments, the pumping action is influenced by the longitudinal movement of the cylinder. In this embodiment, the pushing movement of the cylinder, located upstream of the riser, results in a decrease in the volume of the pump chamber, and the repulsive movement of the cylinder results in an increase in volume. In other words, in these embodiments, the riser maintains its position relative to the housing, and the cylinder can change position relative to the housing, particularly along its longitudinal axis, for example, to perform piston movement of the stationary riser within the cylinder in a movable cylindrical member.

[0042] This arrangement differs from other impact suction devices, such as those disclosed in US 2012 / 0090603 A1, which rely on a pumping unit (with its riser located upstream) and a cylindrical member located downstream, wherein the riser is movable and the cylindrical member is fixed to the housing. The main advantage of the fixed riser arrangement described above is that there are fewer dimensional constraints when designing the passage between the pump chamber and the replaceable reservoir. Significantly larger inlet valves (also known as check valves) can be accommodated, and these are easier to manufacture because they do not have to be contained within the narrow riser. Conversely, the fixed riser design of the pumping unit allows for the use of check valves, the size of which is limited only by the internal dimensions of the housing or the size of the device used to store potential energy. In other words, the diameters of the valve, riser, and (if used) reservoir do not need to match each other. Furthermore, since this embodiment does not require connecting the movable piston to the replaceable reservoir, the components providing fluid connection to the reservoir can be designed independently of the movable component (i.e., the air cylinder), allowing for adjustments to each component to suit its respective function. In this regard, the fixed riser design according to this particular embodiment offers greater design flexibility because the movable air cylinder, due to its robust construction and size, provides better opportunities for designing a mechanically stable connection to the reservoir compared to a less robust movable riser. Additionally, in this embodiment, the connection between the air cylinder and the replaceable reservoir can be designed with a larger diameter, enabling higher flow rates and fluid viscosities. Furthermore, the support for the replaceable reservoir can be integrated into any component including the cylinder. Additionally, in this embodiment, any venting ports for pressure balancing of the replaceable reservoir can be moved from the reservoir body itself to a connector, for example, forming an interface between the replaceable reservoir and the air cylinder of the pumping unit, thus facilitating construction and avoiding the need to provide a substantially "open" reservoir body. This is especially important when the reservoir is designed to be replaceable (as in the case of this invention).

[0043] As described above, the lockable device for storing potential energy is adapted to store energy in its locked state and release the stored energy when unlocked. In a specific embodiment, the lockable device is mechanically coupled to the air cylinder in such a way that unlocking the device causes the air cylinder to move longitudinally toward the downstream end of the pumping unit. During this movement, the internal volume of the cylinder, i.e., the volume of the pump chamber, decreases. Conversely, when the device for storing potential energy is in the locked state, the air cylinder is in its upstream position, at which point the volume of the pump chamber is at its maximum. The locked state can also be considered as the primed state. When the state of the device for storing energy changes from the unlocked state to the locked state (also referred to as the priming device), the air cylinder performs a longitudinal repulsive movement, i.e., a movement from its downstream position toward its upstream position. The pumping cycle includes two consecutive and opposite movements of the air cylinder—a movement from its downstream position to its upstream (or priming) position, and a movement back to its downstream position (driven by the lockable device for storing potential energy that is releasing energy). In a preferred embodiment, the replaceable reservoir moves together with the air cylinder during the movement.

[0044] In a specific embodiment, the pumping unit is a high-pressure pumping unit and is adapted to operate or discharge fluid at a pressure of at least about 50 bar. In other preferred embodiments, the operating pressure of the pumping unit is at least about 10 bar, or at least about 100 bar, or about 2 bar to about 1000 bar, or about 50 bar to about 250 bar. As used herein, the operating pressure is the pressure at which the pumping unit discharges the medically active liquid to be administered (e.g., an inhalable aqueous liquid formulation of a pharmacologically active ingredient) from its pump chamber in a downstream direction (e.g., toward a nozzle). In this document, the expression "adapted to operate" means that the selection of the components of the pumping unit in terms of materials, dimensions, surface quality, and gloss enables operation at a specified pressure.

[0045] Furthermore, this high-pressure pumping unit means that the lockable device for storing potential energy can store and release a sufficient amount of energy to drive the longitudinal propulsion motion of the cylinder by utilizing the force that obtains the corresponding pressure.

[0046] The lockable device for storing potential energy can be designed as a tension or compression spring. Alternatively, a gaseous medium or a magnetically-based material, in addition to metal or plastic, can also be used as an energy storage device. Potential energy is supplied to the device through compression or tension. One end of the device can be supported at or within a suitable location on the housing; therefore, this end is essentially stationary. The other end of the device can be connected to an air cylinder in the pumping unit that provides the pump chamber; therefore, this end is essentially movable. After a sufficient amount of energy has been loaded, the device for storing potential energy can be locked, thus enabling the storage of energy until unlocking occurs. When unlocked, the device can release potential energy (e.g., spring energy) into the cylinder with the pump chamber, which then drives the cylinder to perform (in this case, longitudinal) movement. Typically, the energy release occurs abruptly, thus establishing high pressure in the pump chamber before a large volume of medically active fluid is discharged, which causes a pressure drop. In fact, for most of the jetting phase, the pressure delivered by the device for storing potential energy is balanced with the amount of medically active fluid that has been discharged. Therefore, during this phase, the amount of medically active liquid remains substantially constant. This is a significant advantage for devices that rely on the user's manual force for dispensing (e.g., those disclosed in publications US 2005 / 0039738 A1, US 2009 / 0216183 A1, US 2004 / 0068222 A1, or US 2012 / 0298694 A1), as the manual force depends on the individual user or patient and can vary considerably during the dispensing phase, resulting in uneven droplet formation, size, and quantity. Unlike prior art, the device according to the invention ensures highly reproducible results from the inhalation device.

[0047] In other embodiments, the device for storing potential energy may also be provided in the form of a high-pressure gas container. Through suitable arrangement and the same repetitive intermittent start-up (i.e., opening), some 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 build the required pressure in the pump chamber again. After this, the gas container must be refilled or replaced.

[0048] In a specific embodiment, the lockable device for storing potential energy is a spring having a load of at least 10 N in its deflected state. In a preferred embodiment, the device for storing potential energy is a steel compression spring having a load of about 1 N to about 500 N in its 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 its deflected state.

[0049] In a preferred embodiment, a single dose of the drug (i.e., an aerosol of a medically active liquid) is contained in a single unit, specifically in the volume delivered from the pumping unit to the nozzle to generate the aerosol in a single pumping cycle. In this case, the user or patient will only turn on and actuate the device once per dose (i.e., per dose event) and inhale the released aerosol in a single breathing action.

[0050] In another preferred embodiment, a single dose of the drug consists of two units of aerosol, thus requiring two pump cycles. Typically, the user or patient will turn on the inhalation device, actuate it to release and inhale one unit of aerosol, and then repeat the process. Alternatively, a single administration may consist of three or more aerosol units.

[0051] The volume of fluid (e.g., a medically active liquid) pumped by the pumping unit of the inhalation device system of the present invention in a pumping loop is preferably 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 volume can be in the range of about 2 μL to about 50 μL, or about 5 μL to about 25 μL, more specifically in the range of about 10 μL to about 20 μL (e.g., about 15 μL). These volume ranges are almost the same as the volume of liquid phase contained in a unit of aerosol generated by the inhalation device (may vary slightly due to minor liquid loss in the device).

[0052] In other embodiments, the pumping unit of the inhalation device includes an inlet valve (also referred to as a check valve or inlet check valve) located within the central air cylinder. According to this embodiment, the internal space of the central air cylinder (i.e., the pump chamber) is fluidly connected to a fluid reservoir via the inlet check valve. The inlet valve allows fluid to flow into the pump chamber but prevents backflow of the medically active fluid toward or into the replaceable fluid reservoir. In a preferred embodiment, the inlet valve may be located at or near the upstream end of the cylinder, such that almost the entire internal volume of the central air cylinder is available as the pump chamber. Alternatively, it may be more centrally located along the (longitudinal) main axis of the central air cylinder to define an upstream section and a downstream section of the cylinder, the upstream section being upstream of the inlet valve and the downstream section being downstream of the inlet valve. In this case, the pump chamber is located in the downstream section.

[0053] As previously described, an advantageous embodiment of the pumping unit having a fixed or stationary piston as described above is that an inlet valve of relatively large size can be accommodated at this location (i.e., the upstream end of the pump chamber). This is particularly advantageous because it allows for a large-sized fluid conduit within the valve, thereby enabling high fluid velocities, which will translate into rapid filling of the pump chamber during startup of the inhalation device. Furthermore, it becomes feasible to use medically active liquids with a higher viscosity than conventional inhalation liquid formulations (e.g., high-concentration solutions of soluble active ingredients) in inhalation therapy.

[0054] In other embodiments, the inlet valve may be adapted to open only when the pressure difference between the upstream and downstream sides of the valve (i.e., the fluid reservoir side and the pump chamber side) is above a predetermined threshold, and to remain closed when the pressure difference is below the threshold. Herein, the term "pressure difference" means that whether the valve is blocked or open depends only on the relative pressure difference between the two sides, and not on 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 ambient pressure (e.g., 1.0 bar, with the device not activated), the pressure difference (in this case, 0.01 bar) is below a threshold (e.g., 20 mbar), which causes the valve to remain closed even when subjected to positive pressure in the opening direction. This means that the check valve remains closed until the threshold pressure is reached, thereby keeping the passage between the reservoir and the pump chamber safely closed (e.g., when the suction device is not in use). Examples of threshold pressure differences are in the range of 1 mbar to 1000 mbar, more preferably between about 10 mbar and about 500 mbar, or between about 1 mbar and about 20 mbar.

[0055] When the inhalation device of the inhalation device system of the present invention is actuated, energy is released as the device for storing potential energy changes its state from a locked state to an unlocked state, thereby affecting the cylinder to perform its longitudinal propulsion motion and establishing a significant pressure in the pump chamber. Due to the high pressure in the pump chamber and the significantly lower pressure in the fluid reservoir, this creates a significant pressure difference (exceeding the pressure difference threshold), thereby opening the check valve and allowing medical active liquid from the replaceable reservoir to fill the pump chamber.

[0056] A type of valve designed to operate under this threshold pressure difference is a spring-loaded ball valve. The spring pushes the ball into its seat, and the ball valve only opens when the pressure resisting the spring force exceeds the spring force. Other valve types that can operate under such threshold pressure differences (depending on their construction) are duckbill valves or flap valves.

[0057] The advantage of this valve, which operates based on a threshold pressure difference, is that the reservoir can be kept closed before the inhalation device is actively used, thereby reducing accidental splashing of the medical active liquid stored in the cartridge system during device transport or evaporation during long-term storage of the device.

[0058] In other embodiments, the suction device of the system according to the invention may further include an outlet valve inside the riser or at the end of the riser to prevent liquid or air from flowing back from the riser into the air cylinder. In many cases, the use of such an outlet valve will prove advantageous. Typically, the downstream end of the riser is close to the nozzle. The nozzle is in fluid communication with the outside air. After a certain amount of medically active liquid is released in atomized form (driven by the longitudinal propulsive motion of the cylinder and delivered through the nozzle from the pumping unit), the pump chamber must be refilled. For this purpose, it slides back to its previous upstream position on the riser (i.e., performs a longitudinal repulsive motion), thereby increasing the internal volume of the pump chamber. Simultaneously, a relative negative pressure (sometimes referred to as "under-pressure") is generated inside the pump chamber, causing liquid to be drawn into the pump chamber from a replaceable reservoir located upstream of the pump chamber. However, this relative negative pressure may also propagate downstream through the riser to the outside of the nozzle, and may cause air to be drawn into the device through the nozzle or nozzle opening, respectively. This problem can be avoided by providing an outlet valve (also known as an outlet check valve) that opens toward the nozzle opening and blocks in the opposite direction.

[0059] Optionally, the outlet valve is blocked below the threshold pressure difference described above regarding the inlet valve (opens above this threshold pressure). If a spring-loaded ball valve is used, the spring force must act directly on 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 the threshold pressure difference. The advantages of this valve correspond to the advantages described above.

[0060] As mentioned, the outlet valve can be located within the riser as described above. Alternatively, the suction device includes an outlet valve that is not integrated within the riser but is located at or near one end of the riser, particularly at or near its downstream end, for example in a separate connector between the riser and the nozzle. This implementation may be advantageous in certain situations, such as when a riser with a particularly small diameter is required (which makes valve integration difficult). By placing the outlet valve downstream of the riser, a larger diameter valve can be used, thus simplifying the requirements for valve design.

[0061] In another alternative embodiment, there is no outlet valve. This embodiment may be feasible because the fluid passage of an impingement nozzle may have a relatively small cross-section, resulting in only a small amount of medically active liquid backflow or very slow backflow of the medically active liquid under a given pressure condition during startup of the inhalation device. If the backflow rate is considered acceptable in a particular product application, the design of the inhaler can be simplified by avoiding the outlet valve.

[0062] In any case, whether the inhalation device is designed with an outlet valve or not, all other options and preferences described regarding the other device features apply to these alternative implementations.

[0063] The replaceable reservoir for holding medically active liquids included 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 Vo, wherein the term "total volume" as used herein refers to the volume of the entire cartridge system, including all its components, such as the outer wall of the cartridge system. In a typical embodiment, the total volume Vo of the entire cartridge system can be selected in 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 (e.g., about 2.5 mL to about 20 mL, or about 5 mL to about 15 mL).

[0064] The replaceable cartridge system of the present invention has an upstream end and a downstream end, and includes a container portion having an effective volume Ve for holding a medically active liquid and a connection port adapted to releasably and fluidly connect the cartridge system to a pumping unit (specifically through a connection unit of the receiving unit of the inhalation device).

[0065] In a typical embodiment, the container portion of this replaceable cartridge system has an effective volume Ve selected in the 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, particularly in the range of about 3 mL to about 6 mL, or about 6 mL to about 9 mL, and more particularly in the range of about 4.0 mL to about 5.0 mL, or about 7.0 mL to about 8.0 mL.

[0066] In a specific embodiment, the connection port of the container portion may be in the form of a cap, such as a cap mounted on the downstream end of the container portion. The connection port may have an opening that allows for the establishment of a fluid connection with the inner cavity of the container portion and the medically active liquid contained therein. The term “effective volume” refers to the volume of the entire container portion, including all its components, such as the outer wall of the container portion or the connection port (e.g., the cap). As used herein in relation to hollow bodies (e.g., container portions, or other devices), the term “lumen” or “inner lumen” refers to the internal space or cavity within such hollow bodies, whether that internal space or cavity is wholly or only partially surrounded by the outer wall of the hollow body.

[0067] In other embodiments, the container portion of the replaceable cartridge system of the present invention may be in the form of a flexible container or a rigid (or in other words, a dimensionally stable) container. As used herein, the terms “rigid” or “dimensionally stable” mean that during standard operation of the inhalation device system of the present invention, the container portion does not change its shape or volume when the medically active liquid contained therein is discharged from the container (or in other words, when the medically active liquid is drawn from the container portion through the pumping unit during nebulization and administration of the medically active liquid). In a particular embodiment of the inhalation device system of the present invention, the container portion of the replaceable cartridge system of the present invention is in the form of a dimensionally stable container. In other embodiments, the container portion of the replaceable cartridge system of the present invention is in the form of a dimensionally stable container comprising a flexible or foldable inner container as further described in detail below, wherein the inner container contains the medically active liquid to be administered by the inhalation device system of the present invention.

[0068] Generally, the container portion, especially when provided in a dimensionally stable form, can have any suitable shape that allows the container portion or the entire replaceable cartridge system including such a container portion to be introduced into the inhalation device system of the present invention. In specific embodiments, suitable shapes include, but are not limited to, bottle-shaped, tubular, or cylindrical shapes, wherein symmetrical and asymmetrical shapes can be implemented. In particular, axial symmetry with respect to the main axis of rotation connecting the upstream and downstream centers of the container device or the entire cartridge system allows for advantageous implementations (where the container device or cartridge system can be inserted into the inhalation device only or not only in a particular orientation). However, in a preferred embodiment, the inhaler device or the entire cartridge system may have a substantially circular cross-sectional shape, such that the container device or cartridge system can be introduced into the inhalation device independently of the direction of rotation about the longitudinal main axis.

[0069] In other embodiments, the container portion may be in the form of a bottle with a (main) opening, preferably at its downstream end, for filling or draining the medically active liquid to be stored and administered. However, it should be noted that the container portion may include additional (smaller) openings, for example, for ventilation purposes.

[0070] In a specific embodiment, the container portion of the replaceable reservoir may include an inner container that holds the medically active liquid and has a maximum internal volume Vi. As used herein, the term "internal volume" (Vi) in relation to the container portion refers to the total internal volume of the container portion that can be (partially or completely) filled with liquid (partially or completely) of the medically active liquid administered by the inhalation device system according to the invention. Thus, the internal volume Vi of a container portion fully filled with the medically active liquid corresponds to the volume of the medically active liquid contained in such a fully filled container portion. In a typical embodiment, the maximum internal volume Vi generally corresponds to the effective volume Ve of the container portion and can preferably be selected in the range of about 0.1 to about 15 mL, or about 1 to about 10 mL, particularly in the range of about 3 mL to about 6 mL, or about 6 mL to about 9 mL, and more particularly in the range of about 4.0 mL to about 5.0 mL, or about 7.0 mL to about 8.0 mL. However, in another embodiment, the maximum internal volume Vi of the optional inner container may be less than the effective volume Ve of the container portion, resulting in the optional inner container not filling the entire cavity of the container portion.

[0071] For example, the inner container, which may be included in the container portion of the reservoir, can be designed to be foldable, for example, through flexible or elastic walls. The effect of this design is that, during repeated use of the device involving the gradual emptying of the reservoir, the flexible or elastic walls bend or fold to reduce the internal volume of the reservoir, thereby eliminating the need to significantly increase the negative pressure required to extract a certain amount of liquid during use. In particular, the optional inner container of the replaceable reservoir can be designed as a foldable bag. The advantage of a foldable bag is that the pressure inside the reservoir is almost independent of the fill level, and the effects of thermal expansion are negligible. Moreover, the construction of this type of reservoir is quite simple and well-established. However, in another embodiment, the inner container can have a non-flexible or rigid form, wherein pressure equalization with the surrounding atmosphere during the administration of the medical fluid stored therein is achieved by other means, such as an inlet valve or a movable piston.

[0072] In specific embodiments, the container portion of the cylinder system may be made or manufactured from a polymeric material (particularly thermoplastic polymers such as polyethylene, polypropylene, polyoxymethylene (POM), polystyrene, etc.). In alternative embodiments, the container portion may be made from a metal (e.g., stainless steel, aluminum, or other suitable metals or mixtures thereof). However, in a preferred embodiment, the container portion is made of polyethylene or polypropylene, preferably polypropylene. It should be noted, however, that the separation structures of the container portion, such as connection ports (preferably in the form of caps), may be formed from the same or another metallic or non-metallic material as described above.

[0073] Typically, the cartridge system may have a symmetrical or asymmetrical cross-sectional shape. An asymmetrical cross-section may be advantageous where the cartridge system can only be introduced or received in a specific orientation, and where the receiving unit of the inhalation device may be important. On the other hand, a symmetrical cross-section, such as a circular cross-section (perpendicular to the main central axis connecting the downstream and upstream ends of the replaceable cartridge system), may be beneficial, especially to facilitate insertion of the cartridge system, for example, for infants or users with disabilities.

[0074] The inhalation device system of the present invention includes a combined counting and blocking assembly, which includes a counting unit for counting the number of actuations of the inhalation device system and a blocking unit for blocking the movement of a replaceable reservoir from a rest position to an activated position when a predetermined number of actuations is reached. When the replaceable reservoir is in the rest position, the counting unit and the blocking unit are physically separated from each other and are adapted to interact with each other each time the replaceable reservoir moves from the rest position to the activated position.

[0075] In a preferred embodiment, the blocking and counting components are manually operated and do not include electronic components.

[0076] The blocking unit of this component prevents further use of the reservoir after a predetermined number of uses. The inhalation device system may include a further blocking mechanism that prevents use of the inhalation device system under defined conditions. An example of such a blocking system can be found in WO 2019 / 122451 A1. If the inhalation device system includes a further blocking system, the blocking systems may work in conjunction with each other or independently of each other.

[0077] The counting and blocking assembly of the present invention is characterized in that the blocking unit and the counting unit are physically separated from each other when the replaceable reservoir is in the stationary position. Therefore, the two units can be restarted and / or replaced independently of each other.

[0078] In the context of this invention, physical separation means that when the reservoir is in a stationary position, the movable portion of the counting component does not contact the movable portion of the blocking component. In some embodiments, the counting unit and the blocking unit may each include a housing that separates the two components. The housings of the respective units may or may not be in permanent contact and include openings that allow the movable portions of the blocking unit and the counting unit to interact as the reservoir moves.

[0079] In a preferred embodiment, the blocking unit and the counting unit each include a housing, thereby separating the two systems. Preferably, the two housings do not contact each other when the replaceable reservoir is in the rest position, but are in contact or at least very close to each other when the replaceable reservoir is in the start position.

[0080] When the inhalation device is ready for use and the reservoir is moved to the activation position, the counting component and the blocking component interact. In the context of this invention, interaction means bringing at least two units into physical proximity. In a preferred embodiment of the invention, the counting unit and the blocking unit of the combined counting and blocking component interact as the reservoir moves.

[0081] The interaction can be a reciprocal interaction or a unilateral interaction. Preferably, the type of interaction depends on the state of the inhaler device system. For example, in one embodiment, when the replaceable reservoir is replaced and not in use, the blocking unit and the counting unit can interact reciprocally, with the blocking unit restarting the counting unit and the counting unit initializing the blocking unit. If a predetermined number of uses of the reservoir is reached, the interaction causes the blocking mechanism of the blocking unit to actuate and prevent further use of the reservoir. If the reservoir is in use and the predetermined number of uses has not been reached, the blocking unit can activate the counting unit.

[0082] The outcome of the 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 may restart the counting unit and / or initialize the blocking unit. After a predetermined 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 may be limited and may only involve contact between the two units, i.e., the moving part of one unit contacts the moving part of another unit, or the interaction may be limited to a portion of one unit being moved by another unit through an opening in the housing of that unit. In some embodiments, the counting unit is restartable, preferably after or through a reservoir replacement. Preferably, the counting unit includes a scale device for indicating the number of actuations of the inhalation device system and / or the remaining number of uses before the reservoir is replaced.

[0083] In one particular embodiment, the blocking unit restarts or activates the counting unit after a new replaceable reservoir is inserted during an interaction, and the counting unit initializes the blocking mechanism in the blocking unit. When the device is used after the replaceable reservoir is inserted, but the reservoir has not yet reached its maximum number of uses, the blocking unit activates the counting unit to count the number of uses during each interaction. Once the predetermined number of uses is reached, the counting unit activates the blocking unit and prevents further use of the reservoir.

[0084] In some embodiments, the interaction between the units is achieved through the movement of one of the units. In a preferred embodiment, the blocking unit is movable, axially or longitudinally moved during the device startup step, thereby interacting with the counting unit, while the counting unit remains in the same axial position. In some embodiments, the counting unit is movable, axially or longitudinally moved during the device startup step, thereby interacting with the blocking unit.

[0085] The counting unit and the blocking unit can be securely attached to the inhalation device system or a portion thereof. The counting unit and the blocking unit can be attached to or attached to different parts of the inhalation device system. In some embodiments, one unit is attached to the housing, while the other unit is attached to a replaceable reservoir. In some embodiments, one unit is reversibly and replaceably attached to the housing, while the other unit is fixed to the replaceable reservoir. In some embodiments, one unit is permanently attached to the housing or a portion thereof, while the other unit is permanently attached to the replaceable reservoir and replaced along with the reservoir.

[0086] In some embodiments, the counting unit is connected to the housing of the inhalation device system. In a particular embodiment, the counting unit is connected to a lower housing portion. In some embodiments, the housing portion is movable or removable. In some embodiments, the counting unit is detachably connected to the housing portion. In another embodiment, the counting unit is non-detachably connected to the housing portion. The housing portion can be moved or detached to allow replacement of the replaceable reservoir.

[0087] In some embodiments, the counting unit is connected to the inner surface of the housing of the inhalation device system. In a particular embodiment, the counting unit is detachably connected to the inner surface of the housing. In other embodiments, the counting unit is permanently connected to the inner surface of the housing. In some embodiments, the counting unit is connected to the inner surface of a movable portion of the housing.

[0088] In some embodiments, a unit of the counting and blocking assembly is connected to a replaceable reservoir. In a preferred embodiment, the blocking unit of the combined assembly is connected to the replaceable reservoir. In some embodiments, the blocking unit is securely connected to the replaceable reservoir and is replaced along with the reservoir. In these embodiments, the blocking unit moves with the reservoir in the inhalation device system. For smooth operation of the inhalation device system, it is preferable that the entire cylinder assembly does not interfere with the inhaler body. Therefore, it is preferable that the blocking device has a cross-sectional diameter substantially the same as that of the replaceable reservoir. In some embodiments, the cross-sectional diameter is smaller than that of the reservoir. Particularly preferred is that both the blocking unit and the replaceable reservoir have circular cross-sections.

[0089] The blocking unit can be attached to the replaceable reservoir in any manner. A skilled technician knows suitable attachment methods. The blocking unit can 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 via a force-fit or form-fit connection.

[0090] The connection between the blocking unit and the replaceable reservoir can be made through the housing of the blocking unit. The housing of the blocking unit may include an opening at its downstream end that connects to the replaceable reservoir. The opening of the housing of the blocking unit preferably has a diameter corresponding to the outer diameter of the upstream end of the replaceable reservoir. The opening may, for example, include threads for connecting the blocking unit to the replaceable reservoir.

[0091] The replaceable reservoir may be in the form of a replaceable cylinder having an upstream end and a downstream end, and the blocking unit is connected to the upstream end of the replaceable reservoir.

[0092] If the blocking unit is connected to the replaceable reservoir, it is preferable that the blocking unit and the replaceable reservoir are assembled and sterilized before the reservoir is filled with medical active liquid.

[0093] It is preferable if the blocking unit cannot be removed from the reservoir or is difficult to remove from the reservoir. In a preferred embodiment, the blocking unit is connected to a replaceable reservoir, and the force required to remove the blocking unit from the replaceable reservoir is greater 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.

[0094] In some embodiments, the replaceable reservoir is provided in the form of a cylinder having an outer (dimensionally stable) housing including an inner container in the form of a bag (specifically, a collapsible bag) for containing medically active liquids, and a blocking unit is attached to the housing.

[0095] In some embodiments, the replaceable reservoir including the blocking unit has a cylindrical shape, and its central longitudinal axis (A) connects the connection port (32) of the replaceable reservoir (31) located at the downstream end of the replaceable reservoir (30) to the upstream end of the blocking unit connected to the upstream end of the replaceable reservoir.

[0096] The blocking unit includes a blocking mechanism.

[0097] In some embodiments, the blocking unit further includes a housing containing a blocking mechanism. In a preferred embodiment, the blocking unit includes a housing and a blocking mechanism, wherein the housing of the blocking unit includes an opening for interaction between the counting unit and the blocking mechanism. In some embodiments, the opening is located at the upstream end of the blocking unit.

[0098] The blocking mechanism preferably prevents the replaceable reservoir from moving from the rest position to the start position after startup.

[0099] This movement can be prevented by the blocking unit itself or through interaction with other parts of the inhaler device system. In a preferred embodiment, the blocking mechanism prevents movement of the replaceable reservoir associated with the activation mechanism of the counting unit.

[0100] The counting unit includes a counting mechanism and an actuation mechanism. The counting mechanism counts the actuations of the inhaler device system. The term actuation of the inhaler device system refers to all steps that initiate the release of the liquid. These steps include rotating the lower housing portion to actuate the mechanism, bringing the reservoir into the actuated position; actuating the actuator components to release the reservoir from the actuated position and release the fluid.

[0101] In the context of the present invention, the counting mechanism is therefore preferably used to count at least one of the following: l rotation of at least one housing portion; l movement of a replaceable reservoir; l activation of an actuator component.

[0102] In a preferred embodiment, the counting mechanism counts the actuation as early as possible. For example, if the counting mechanism counts the rotation of the lower housing portion, it is preferable that the rotation is counted in advance during the rotation. In a preferred embodiment, the counting mechanism is activated by the vertical movement of a counting member that moves by rotating the lower housing portion. The counting member may be part of a blocking unit.

[0103] The counting unit may include an indicator device that displays the number of uses. In some embodiments, the indicator device displays the remaining number of uses of the reservoir; in other embodiments, the indicator device displays the number of uses of the reservoir.

[0104] Alternatively, the counting mechanism can be operated by the interaction between the blocking unit and the counting unit when the replaceable reservoir is moved from the rest position to the start position.

[0105] In addition to the counting mechanism, the counting unit also includes a starting mechanism. In a preferred embodiment, the starting mechanism interacts with the blocking unit, and preferably interacts with the blocking mechanism of the blocking unit.

[0106] The result of the interaction between the activation mechanism and the blocking unit depends on the states of the blocking unit and the counting unit. In a preferred embodiment of the invention, the interaction between the activation mechanism and the blocking unit will result in one of the following: l If the reservoir is replaced after a predetermined number of uses, the interaction will cause the counting unit to restart; l If the reservoir has been in continuous use and the predetermined number of uses has been reached, the interaction will activate the blocking mechanism and prevent further use of the reservoir; l If the reservoir has been in continuous use and the predetermined number of uses has not yet been reached, the interaction will have no effect, or the interaction will activate the counting unit to count one use of the inhalation device system.

[0107] In some embodiments, the starting mechanism includes an starting member. In a preferred embodiment, the starting mechanism includes a movable starting member. The starting member can be a gear or a pin. In a preferred embodiment, the starting member is a pin. In some embodiments, the starting mechanism is driven by a counting mechanism. In other embodiments, the starting mechanism can be driven independently of the counting mechanism.

[0108] In some embodiments, the actuating member of the actuating mechanism interacts with the blocking mechanism and / or the counting mechanism. In some embodiments, the actuating member interacts with a movable component in the blocking mechanism. In some embodiments, the actuating member is a pin that interacts with the blocking mechanism after a predetermined number of uses. For example, after a predetermined number of uses of the reservoir, the actuating member causes the movable component in the blocking mechanism to move, resulting in the blocking mechanism being actuated. In some embodiments, the actuation of the blocking mechanism is reversible. In a preferred embodiment, the actuation of the blocking mechanism is irreversible.

[0109] In a preferred embodiment, the actuating member of the actuating mechanism of the counting unit enters the opening of the blocking unit when the replaceable reservoir is moved from the rest position to the actuating position, so as to interact with the blocking mechanism. Once a predetermined number of uses is reached, the movable actuating member activates the blocking mechanism.

[0110] In some embodiments, the movable actuating member is driven by a counting mechanism. In some embodiments, the movable actuating member moves gradually or stepwise with each activation of the counting mechanism. In this case, the actuating member may be a pin exposed from the counting unit, thereby interacting with the blocking unit as the reservoir moves. The pin can change position when the counting unit is activated. Therefore, the position of the actuating member is controlled by the counting unit.

[0111] In a preferred embodiment, the activation component is movable and moves gradually, for example, step by step, and the position of the component depends on the number of times the replaceable reservoir is used.

[0112] In a preferred embodiment, the actuating member is controlled by a counting mechanism. In some embodiments, the counting mechanism includes a rotatable member having a selectable circular ramp on which the actuating member is supported. In a preferred embodiment, each actuation of the counting mechanism causes the rotatable member to move on the ramp, preferably by sliding gradually on the upper surface ramp.

[0113] In a preferred embodiment, the rotatable component moves along the inclined surface of the ramp under the drive of the counting mechanism, preferably gradually. The movement of the rotatable component also drives the actuating component, which moves slowly upward in the axial or downstream direction as the rotatable component moves on the inclined surface. When the rotatable component reaches the highest point of the ramp, the actuating component is in its highest position.

[0114] In a specific embodiment of the invention, the actuating member is at the highest point of the ramp surface after the predetermined number of uses, and / or at the highest point when a new replaceable reservoir is inserted. After the reservoir is replaced, the next actuation of the inhalation device system will move the actuating member to the lowest position on the ramp surface, preferably simultaneously restarting the counting unit. Then, each actuation of the inhalation device system will cause the actuating member to gradually move (e.g., by stepwise movement) to the highest position on the ramp member, which is reached after the predetermined number of uses, thereby activating the blocking mechanism of the blocking unit.

[0115] The rotatable component and the actuating component can be a single piece or two separate components. In a preferred embodiment, the rotatable component and the actuating component are a single piece, or the actuating component is connected to the rotatable component.

[0116] In one particular embodiment, the blocking mechanism includes an opening for an initiating member. This opening allows the initiating member to enter and, after the blocking mechanism is activated, restricts the blocked component. After a predetermined number of uses, the initiating member is positioned at the upper end of the ramp and, when the space behind the opening is limited to prevent significant movement of the reservoir, the blocking member is preferably no longer movable until the reservoir is replaced so that the counting mechanism can be restarted.

[0117] In a particular embodiment, the blocking system includes two components that are interconnectable. The components have a movable configuration and a blocking configuration. The first component or fixed component includes a hollow tube, wherein at least a portion of the second component or movable component is movable. In the movable configuration, the second component is driven by an actuating component of the counting unit during reservoir movement and moves within the hollow tube of the first component. The components can be implemented as plungers and cams. In the movable configuration, the non-moving component maintains the same relative position to the reservoir. If the actuating component is moved far enough, after a predetermined number of uses, the two components lock together, entering the blocking configuration. In the blocking configuration, both components move to the blocking position, optionally interlock, and restrict the space of the actuating component. In the blocking position, both components are fixed and cannot move.

[0118] In an alternative embodiment, the blocking system may include two components: a moving component and a guiding component. The guiding component includes a hollow tube that allows the moving component to move. The moving component and the guiding component may be implemented in the form of a plunger and a cam. The movement of the moving component is driven by an actuation component of the counting unit. The moving component or the guiding component may include a protruding element. The blocking unit may optionally include a groove or a corresponding protrusion that mates with a protruding element in one of the components. During actuation of the inhaler device system, the moving component moves according to the number of uses. After a predetermined number of uses, the protrusion of the moving or guiding component moves into the groove, thereby preventing further movement of the moving component and thus limiting the space behind the opening to allow the actuation component to enter only through the opening portion of the housing of the blocking unit, and correspondingly, preventing the actuation component from fully entering.

[0119] In another aspect, the present invention relates to a cartridge system for containing a medically active liquid for atomization and suitable for use in an inhalation device system (10) as defined above. The replaceable cartridge system of the present invention has an upstream end and a downstream end, and includes a container portion having an effective volume Ve for containing the medically active liquid and a connection port suitable for releasably and fluidly connecting the cartridge system to a pumping unit, specifically through a connection unit of the receiving unit of the inhalation device, wherein a blocking unit as defined above is connected to the upstream end of the container portion.

[0120] The general cylindrical system has been defined and explained in detail above. The above details can be combined with the specific implementation schemes defined below.

[0121] In a further specific embodiment, the container portion of the interchangeable ink cartridge system of the present invention is in the form of a dimensionally stable container, to which the blocking unit defined above is connected.

[0122] The blocking unit can be permanently or detachably connected. Preferably, the blocking unit is permanently connected. The blocking unit is a blocking unit as defined above, preferably including a housing connected to the container. The housing can be made of the same or different material as the outer shell of the container or cylinder.

[0123] As described above, it is preferable to assemble and sterilize the cylinder system before filling it with medical fluid.

[0124] In another aspect, the present invention relates to an inhalation device for an inhaler device system, wherein the inhalation device comprises: - a housing having a receiving unit having a connecting unit adapted to be releasably and fluidly connected to a connection port of a replaceable reservoir, the receiving unit being adapted to receive and fluidly connected to the replaceable reservoir; - a nozzle for atomizing the medically active liquid; and - a pumping unit disposed within the housing and adapted to be fluidly connected to the nozzle and connectable to the replaceable reservoir, and adapted to deliver the medically active liquid from the replaceable reservoir downstream to the nozzle, and adapted to move the replaceable reservoir from a rest position to an activated position when the pumping unit is activated; characterized in that the inhalation device comprises at least one of: a counting unit as defined above, adapted to interact with a blocking unit; and / or a blocking unit as defined above, adapted to interact with the counting unit.

[0125] In a preferred embodiment, the inhalation device includes a counting unit as defined above—which is adapted to interact with a blocking unit. In a particular embodiment, the blocking unit interacting with the counting unit is part of a replaceable reservoir. The inhalation device may include additional blocking devices for blocking operation, but these blocking devices do not interact with the counting unit in the manner defined above.

[0126] The present invention further relates to embodiments numbered as follows.

[0127] 1. An inhalation device system (10) for inhalation administration of a medically active liquid in atomized form, the system comprising an inhalation device (20) and a replaceable reservoir (30) for holding multiple doses of the medically active liquid, wherein each time the inhalation device system is actuated, a dose of the medically active liquid is dispensed from the inhalation device, wherein the inhalation device (20) comprises: - a housing (21) having a receiving unit (23) 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 and fluidly connect to the replaceable reservoir (30); - a nozzle (25) for atomizing the medically active liquid; and - A pumping unit (40), disposed within the housing (21) and adapted to be fluidly connected to the replaceable reservoir (30) and the nozzle (25), and adapted to deliver the medically active liquid from the replaceable reservoir (30) (downstream) to the nozzle (25), and adapted to move the replaceable reservoir from a rest position to an activated position when the pumping unit is activated, wherein the inhalation device system includes a combined counting and blocking assembly comprising: a counting unit for counting the number of actuations of the inhalation device system (after the replaceable reservoir is inserted into the inhalation device); and a blocking unit for preventing the replaceable reservoir from moving from the rest position to the activated position when a predetermined number of actuations is reached (after the replaceable reservoir is inserted into the inhalation device), wherein the counting unit and the blocking unit are physically separated when the replaceable reservoir is in the rest position, and are adapted to interact each time the replaceable reservoir moves from the rest position to the activated position.

[0128] 2. The inhalation device system according to claim 1, wherein the counting unit is connected to the housing of the inhalation device.

[0129] 3. The inhalation device system according to claim 1 or 2, wherein the blocking unit is connected to the replaceable reservoir.

[0130] 4. The inhalation device system according to any of the foregoing claims, wherein the operation of the combined blocking and counting unit does not include electronic components.

[0131] 5. The inhalation device system according to any one of the foregoing claims, wherein the housing of the inhalation device has a fixed portion (including the pumping unit, nozzle and receiving unit) and a movable portion (movable from a closed state to an open state and from a stationary position to an activated position), wherein the counting unit is connected to the movable portion of the housing.

[0132] 6. The inhalation device system according to claim 5, wherein the movable portion of the housing is in the form of a cover that covers and closes the receiving unit of the housing.

[0133] 7. The inhalation device system according to any of the foregoing claims, wherein the counting unit is (permanently) connected to the inner surface of the (movable portion) of the housing of the inhalation device.

[0134] 8. The inhalation device system according to any of the foregoing claims, wherein the counting unit (when the replaceable reservoir is replaced) is restartable.

[0135] 9. The inhalation device system according to any of the foregoing claims, wherein the blocking unit is securely connected to the replaceable reservoir.

[0136] 10. The inhalation device system according to any one of claims 1 to 8, wherein the blocking unit is releasably connected to the replaceable reservoir.

[0137] 11. The inhalation device system according to any of the preceding claims, 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 connected to the upstream end of the replaceable cartridge.

[0138] 12. The inhalation device system according to any of the preceding claims, wherein the blocking unit has a housing containing a blocking mechanism.

[0139] 13. The inhalation device system according to claim 12, wherein the housing of the blocking unit includes an opening for physical interaction between the counting unit and the blocking mechanism.

[0140] 14. The inhalation device system according to claim 13, wherein the opening of the blocking unit is located at the upstream end of the blocking unit.

[0141] 15. The inhalation device system according to any of the preceding claims, wherein the counting unit includes a counting mechanism and an actuation mechanism.

[0142] 16. The inhalation device system according to any of the preceding claims, wherein the actuation mechanism interacts with the blocking mechanism of the blocking unit.

[0143] 17. The inhalation device system according to any of the preceding claims, wherein the actuation mechanism includes an actuation member (in the form of a pin) for interacting with the blocking mechanism of the blocking unit.

[0144] 18. The inhalation device system according to claim 17, wherein the actuation member of the counting unit enters the opening of the blocking unit to interact with the blocking mechanism when the replaceable reservoir moves from the rest position to the actuation position.

[0145] 19. The inhalation device system according to claim 17 or 18, wherein the position of the actuating member is controlled by the counting mechanism.

[0146] 20. The inhalation device system according to any of the preceding claims, wherein the counting mechanism operates through (physical / mechanical) interaction with the blocking unit when the replaceable reservoir is moved from the rest position to the activation position.

[0147] 21. The inhalation device system according to any of the preceding claims, wherein the counting mechanism includes a scale device for indicating (after insertion of the replaceable cartridge) the number of times the inhalation device system is actuated.

[0148] 22. The inhalation device system according to any of the preceding claims, wherein the counting mechanism includes a rotatable member having a (circular) ramp, and the actuation member is supported on the ramp.

[0149] 23. The inhalation device system according to any of the preceding claims, wherein the blocking unit includes a blocking member that is initially activated so as to "transfer" to a blocking state after interacting with the counting mechanism (after insertion of the replaceable cartridge) a defined number of actuations of the inhalation device system.

[0150] 24. The inhalation device system according to any of the preceding claims, wherein when (after the replaceable reservoir is inserted into the inhalation device) a predetermined number of actuations is reached, the blocking member of the blocking unit is moved to the blocking position.

[0151] 25. The inhalation device system (10) according to any of the preceding claims, wherein the replaceable reservoir is provided in the form of a cylinder having an outer (dimensionally stable) housing including an internal container for containing a medically active liquid, in the form of a bag, specifically a collapsible bag.

[0152] 26. An inhalation device system (10) according to any one of claims 10 to 25, wherein the force required to remove the blocking unit from the replaceable reservoir is greater than the force required to remove the replaceable reservoir from the receiving unit (23) of the inhalation device (20).

[0153] 27. The inhalation device system (10) according to any of the foregoing claims, wherein the replaceable reservoir of the blocking unit has a cylindrical shape, and its central longitudinal axis (A) connects the connection port (32) of the replaceable reservoir (31) located at the downstream end of the replaceable reservoir (30) to the upstream end of the blocking unit connected to the upstream end of the replaceable reservoir.

[0154] 28. The inhalation device system (10) according to any of the preceding claims, wherein the replaceable reservoir (31) has an upstream end (34) and a downstream end (35), wherein the connection port (32) is located at the downstream end (34) of the replaceable reservoir (31), and wherein an extension of the blocking unit is connected to the upstream end (35) of the replaceable reservoir.

[0155] 29. The inhalation device system (10) according to any of the foregoing, wherein the blocking unit (33) is connected to the outer surface of the replaceable reservoir (31) by force fit or form fit.

[0156] 30. The inhalation device system (10) according to any of the foregoing claims, wherein the cross-sectional diameter of the blocking unit (33) is substantially the same as that of the replaceable reservoir (31).

[0157] 31. The inhalation device system (10) according to any of the preceding claims, wherein the blocking unit (33) and the replaceable reservoir (30) have a circular cross-section.

[0158] 32. The inhalation device system (10) according to any of the foregoing claims, wherein the (housing) of the blocking unit (33) has an opening (37) at its downstream end, the diameter of which corresponds to the (outer) diameter of the upstream end (34) of the replaceable reservoir.

[0159] 33. The inhalation device system (10) according to any of the preceding claims, wherein the replaceable reservoir (31) and the blocking unit (33) are assembled and sterilized before the cartridge system (30) is filled with the medical active liquid.

[0160] 34. The inhalation device system (10) according to any of the preceding claims, wherein the replaceable reservoir (30) has an effective volume Ve selected from the range of about 0.1 to about 15 mL.

[0161] 35. The inhalation device system (10) according to any of the preceding claims, wherein the pumping unit (40) of the inhalation device (20) comprises: - an upstream end fluidly connected to the replaceable reservoir (30); - a downstream end fluidly connected to the nozzle (25); wherein the pumping unit further comprises (i) a riser (43) having an upstream end, wherein the riser (43) is - adapted to serve as a piston in the pumping unit; and - firmly attached to the user-facing side of the housing (21) so as not to move relative to the housing (21); and (ii) an air cylinder (41) located at the upstream end of the riser (44), wherein the upstream end of the riser (43) is inserted into the cylinder (41) such that the cylinder (41) is longitudinally movable on the riser (43).

[0162] 36. The inhalation device system (10) according to claim 35, wherein the pumping device (40) includes (iii) a lockable device for storing potential energy (46) when locked and releasing the stored energy when unlocked, the device (46) being arranged outside and mechanically coupled to the cylinder (41) such that unlocking the device (46) causes the cylinder (41) to move longitudinally in a pushing manner toward the downstream end of the pumping unit.

[0163] 37. The inhalation device system according to any of the preceding claims, wherein the inhalation device is a handheld inhalation device.

[0164] 38. The inhalation device system according to any of the preceding claims, wherein the inhalation device is a soft mist inhaler, which includes at least one impact nozzle.

[0165] 39. The inhalation device system according to claim 38, wherein the at least one impact nozzle includes at least two channels for spraying at least two jets of medically active liquid, wherein the orientation of the at least two liquid channels is such that the trajectories of the at least two jets intersect at at least one point of impact.

[0166] 40. The inhalation device system according to any of the preceding claims, wherein the inhalation device system and / or medical active liquid do not include a propellant, such as a hydrofluorocarbon (HFC) propellant.

[0167] 41. A replaceable cartridge system (30) for containing a medically active liquid for atomization and adapted for use in an inhalation device system (10) according to any of the preceding items, wherein the cartridge system includes a container portion having an effective volume Ve for containing the medically active liquid and a connection port adapted to releasably and fluidly connect the cartridge system to the pumping unit, particularly through the connection unit of the receiving unit of the inhalation device, wherein a blocking unit is connected to the upstream end of the container portion.

[0168] Detailed Description of the Attached Drawing

[0169] The present invention will be further described with reference to the accompanying drawings. The drawings show specific, but not limiting, embodiments of the invention.

[0170] Figure 1 illustrates an inhalation device system (10) according to the prior art, comprising an inhalation device (20) and a replaceable reservoir in the form of a cartridge system (30) inserted into the inhalation device (different components of the cartridge system are not shown). The inhalation device (20) has a housing (21) with a lower portion (22) that can be detached from and 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) also has a connecting unit (24) adapted to be releasably and fluidly connected to a connection port (32) of the replaceable reservoir.

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

[0172] The pumping unit (40) has an upstream end (41) fluidly connected to a replaceable reservoir (30); a downstream end (42) fluidly connected to a nozzle (25); wherein the pumping unit (40) further includes (i) a riser (43) having an upstream end (44), wherein the riser (43) is adapted to serve as a piston in the pumping unit (40), and wherein the riser (43) is securely fixed to the user-facing (downstream) side of the housing (21) so as to be immovable relative to the housing (21); and (ii) an air cylinder (45) located upstream of the riser (43), wherein the upstream end of the riser (44) is inserted into the cylinder (45) such that the cylinder (45) is longitudinally movable on the riser (43).

[0173] Also as shown in FIG1, the pumping unit (40) includes (iii) a lockable device (46) for storing potential energy (46) when locked and releasing the stored energy when unlocked. The device (46) is arranged outside the cylinder (45) and mechanically coupled to the cylinder (45), such that unlocking the device (46) causes the cylinder (45) to move longitudinally toward the downstream end of the pumping unit (42).

[0174] FIG2 shows an exemplary embodiment of an inhalation device system (10) according to the invention in a fully assembled state. The inhalation device system includes an inhalation device (20) having an insertable replaceable reservoir in the form of a cartridge system (30). In this particular embodiment, the inhalation device includes a counting unit (32), and the cartridge system of the reservoir includes a blocking unit (33).

[0175] The counting unit is part of the lower housing portion (22) of the inhalation device (20). The lower housing portion (22) can be detachably separated or opened, for example, via a hinge (not shown).

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

[0177] Figure 3 shows a schematic diagram of the lower part of the outer casing (22), without the upper outer casing portion. The counting unit (32) is located in the movable base (27) of the inhalation device system. The replaceable cartridge system (30) includes a container portion (31) and a blocking unit (33). The blocking unit (33) is physically separate from the counting unit (32) and includes a counting member (65) that can interact with the counting unit.

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

[0179] The counting unit (32) includes a housing (51) in which a counting mechanism is disposed. The counting mechanism includes a movable sled-like component (54) that drives a counting gear (53) to move an indicator component (55) comprising faceted teeth and a ramp (58). A scale device (56) is located on the outside of the indicator component (55) for indicating the number of uses of the inhaler device system. The counting unit also includes an actuation component (52) that can move on the ramp according to its position on the ramp to increase the height. This actuation component is adapted to interact with a blocking mechanism.

[0180] Figure 5 shows an overview of one embodiment of a cylinder system according to the invention, which includes a blocking device according to the invention. Figure 5A shows the container portion (31) of the cylinder system, which can be connected to the housing of the blocking unit (61), and includes a counting member (65) to interact with the counting unit. The blocking system includes a plunger (62) and a cam (63), which can interact and are held together by a spring (64) mechanism.

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

[0182] Figures 6A to 6C show embodiments of the counting mechanism and possible interactions between the blocking unit and the counting unit. Figure 6A shows the inhalation device system in a stationary position. The counting member of the blocking system is located above the opening of the counting unit and does not interact with the counting unit. The movable sled (54) of the counting mechanism is in a neutral position. The position of the activation member (52) on the ramp (58) of the indicator member (55) depends on the number of previous uses. Figure 6A shows an early stage shortly after the insertion of a new replaceable reservoir, where the activation member (62) is in a low position on the ramp.

[0183] Figure 6B shows the inhalation device system in the activating position. The counting component (65) of the blocking unit has entered the opening (57) of the counting unit, thereby moving the movable sled (54). The movement of the movable sled drives the counting gear (53), which in turn moves the indicator component (55), causing the indexing device (56) to advance and the activating member (52) to move upward on the ramp. Figure 6B further shows that the activating member does not interact with the blocking unit until a predetermined number of uses has been reached.

[0184] Figure 6C shows the interaction between the counting unit and the blocking unit after a predetermined number of uses has been reached. The starting member (52) has moved on the ramp (58) and is now able to interact with the blocking unit through its interaction with the plunger (62).

[0185] Figures 7A to 7D show another embodiment of the counting mechanism. The counting mechanism includes an actuation member (52) which is placed on a ramp (58) to interact with a timing mechanism after a predetermined number of actuations.

[0186] Figure 7A shows the counting mechanism through a cross-section of the housing (51), and Figure 7B shows a cross-section of the counting mechanism. Figure 7C shows the interior portion of the housing (51) and the actuating member (52) placed on the ramp (58).

[0187] Figure 7D shows the various parts of the counting mechanism.

[0188] This alternative counting mechanism includes a drive member (57) instead of a movable sled-like object (54). The drive member includes 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 device. The drive member is movable and can return to its original position under the action of a spring (64).

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

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

[0191] Figures 8B and 8C show the activation of the blocking mechanism. After the activation member (52) of the counting unit is activated, the plunger (62) moves and activates the cam (63), causing the cam to disengage from the protrusion (66) (Figure 8B). Due to the spring mechanism (not shown), the cam (62) moves along the protrusion (66) to the blocking position (Figure 8C), thereby preventing further movement of the plunger (62) and the cam (63). In this case, the activation member (52) of the counting unit prevents further movement of the cartridge, thereby preventing further use of the cartridge. [Figure 1] depicts a cross-sectional view of an inhalation device system, according to the prior art, the system having a cartridge inserted into the inhalation device. [Figure 2] depicts a schematic embodiment of an inhalation device system according to the invention. [Figure 3] depicts a schematic diagram of the lower part of an inhalation device system, showing the lower part of the device with a counting unit and a replaceable reservoir, which is in the form of a container system containing the blocking unit. [Figures 4A, 4B and 4C] show an overview of an exemplary embodiment of the counting unit. [Figures 5A and 5B] show an overview of an exemplary embodiment of a blocking unit that can be selectively connected to an interchangeable container. [Figures 6A, 6B, and 6C] show an exemplary embodiment of a counting unit and its potential interaction with the blocking unit. [Figures 7A, 7B, 7C, and 7D] show another exemplary embodiment of a counting unit. [Figures 8A, 8B, and 8C] show an exemplary embodiment of a blocking unit and a blocking mechanism.

Claims

1. An inhalation device system (10) for inhalation administration of a medically active liquid in atomized form, the system comprising an inhalation device (20) and a replaceable reservoir (30) for holding multiple doses of the medically active liquid, wherein each time the inhalation device system is actuated, a dose of the medically active liquid is dispensed from the inhalation device, wherein the inhalation device (20) comprises: - A housing (21) having a receiving unit (23) having a connecting 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 and fluidly connect to the replaceable reservoir (30); - A nozzle (25) for atomizing the medical active liquid; And a pumping unit (40), which is disposed within the housing (21) and adapted to be fluidly connected to the replaceable reservoir (30) and the nozzle (25), and adapted to deliver the medically active liquid from the replaceable reservoir (30) (downstream) to the nozzle (25), and adapted to move the replaceable reservoir from a rest position to an activated position when the pumping unit is activated, characterized in that the inhalation device system includes a combined counting and blocking assembly comprising: a counting unit for counting the number of actuations of the inhalation device system (after the replaceable reservoir is inserted into the inhalation device); and a blocking unit for preventing the replaceable reservoir from moving from the rest position to the activated position when a predetermined number of actuations is reached (after the replaceable reservoir is inserted 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 are adapted to interact (physically) each time the replaceable reservoir moves from the rest position to the activated position; Alternatively, the blocking unit may be connected to the replaceable reservoir, while the counting unit may be connected to the housing of the inhalation device; or the counting unit may be connected to the replaceable reservoir, while the blocking unit may be connected to the housing of the inhalation device.

2. The inhalation device system as claimed in claim 1, wherein the counting unit is connected to the housing of the inhalation device, and wherein the blocking unit is connected to the replaceable reservoir.

3. The inhalation device system as described in any of the preceding claims, wherein, The replaceable reservoir is in the form of a replaceable cylinder having an upstream end and a downstream end, and the blocking unit is connected to the upstream end of the replaceable cylinder.

4. The inhalation device system as claimed in any of the preceding claims, wherein the blocking unit has a housing containing a blocking mechanism.

5. The inhalation device system as claimed in claim 4, wherein the housing of the blocking unit includes an opening for interaction between the counting unit and the blocking mechanism.

6. The inhalation device system as claimed in any of the preceding claims, wherein the counting unit includes a counting mechanism and an actuation mechanism.

7. The inhalation device system as claimed in any of the preceding claims, wherein the actuation mechanism interacts with the blocking mechanism of the blocking unit.

8. The inhalation device system as claimed in any of the preceding claims, wherein the actuation mechanism includes an actuation member for interacting with the blocking mechanism of the blocking unit; wherein the actuation member is movable, and the position of the actuation member changes with each actuation of the inhaler device system.

9. The inhalation device system as claimed in claim 8, wherein the actuating member moves gradually or incrementally with each actuation.

10. The inhalation device system as claimed in claim 8 or 9, wherein the actuation member of the blocking unit enters the opening of the blocking unit to interact with the blocking mechanism when the replaceable reservoir moves from the rest position to the actuation position.

11. The inhalation device system of any of the preceding claims, wherein the counting mechanism operates through interaction with the blocking unit when the replaceable reservoir is moved from the rest position to the activation position.

12. The inhalation device system as claimed in any of the preceding claims, wherein the blocking unit includes a blocking mechanism that, after a predetermined number of uses, restricts the space available for the activation member so that it is no longer possible to move the replaceable reservoir to the activation position.

13. A replaceable cartridge system for an inhalation device system comprising a combined counting and blocking assembly as claimed in any one of claims 1 to 12, the replaceable cartridge system being for containing a medically active liquid for nebulization and adapted for use in an inhalation device system as described in any one of the preceding claims, wherein, The cartridge system includes a container portion having an effective volume Ve for containing the medically active liquid and a connection port adapted to releasably and fluidly connect the cartridge system to the pumping unit, particularly through the connection unit of the receiving unit of the inhalation device, wherein the cartridge system includes a blocking unit adapted to interact with a counting unit of the inhalation device, as described in any one of claims 1 to 12, which includes a combined counting and blocking assembly.

14. An inhalation device for an inhalation device system including a combined counting and blocking component as claimed in any one of claims 1 to 12, wherein the inhalation device comprises: - A housing having a receiving unit having a connecting unit adapted to be releasably and fluidly connected to a connection port of the replaceable reservoir, the receiving unit being adapted to receive and fluidly connect to the replaceable reservoir; - A nozzle used for atomizing the medical active liquid; And - a pumping unit disposed within the housing and adapted to be fluidly connected to the nozzle and connectable to a replaceable reservoir, and adapted to deliver the medically active liquid from the replaceable reservoir downstream to the nozzle, and adapted to move the replaceable reservoir from a rest position to an activated position when the pumping unit is activated; characterized in that the inhalation device comprises at least one of: - a counting unit adapted to interact with a blocking unit of the combined counting and blocking assembly as described in any one of claims 1 to 12; and / or - a blocking unit adapted to interact with a counting unit of the combined counting and blocking assembly as described in any one of claims 1 to 12.

Images