Inhalation device system

Abstract

The present invention provides an inhalation device system for inhalation administration of a medically active liquid in nebulized form.SOLUTION: The system comprises an inhalation device and a replaceable reservoir for holding a medically active liquid, wherein the inhalation device comprises a housing having a receiving unit, wherein the receiving unit has a connection unit adapted for releasable fluid connection to a connection port of the replaceable reservoir, wherein the receiving unit comprises a housing adapted for receiving and fluid connection to the replaceable reservoir, a nozzle for nebulizing the medically active liquid, and a nebulizer arranged in the housing and adapted for fluid connection to the reservoir (via the connection unit of the receiving unit) and the nozzle; A pump unit adapted to convey (pressurize, pump) the medically active liquid in a downstream direction from the reservoir to the nozzle.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to the field of inhalation devices for medically active liquids, in particular to an inhalation device system comprising an inhalation device and a replaceable reservoir for holding a medically active liquid, the replaceable reservoir being provided in the form of a cartridge system comprising a container portion and an extension element. [Background technology]

[0002] Nebulizers or other aerosol generators for liquids have long been known in the art. Among other uses, such devices are used in medicine and therapy. There, they function as inhalation devices for administering an active ingredient in the form of an aerosol, i.e., small droplets embedded in a gas. Such an inhalation device is known, for example, from European Patent No. 0,627,230. The essential components of this inhalation device include a reservoir containing the liquid to be aerosolized, a pumping device for generating a pressure high enough to atomize the liquid, and an atomizing device in the form of a nozzle. The pumping device draws the liquid from the reservoir in discrete amounts, i.e., not continuously, and delivers it to the nozzle. The pumping device operates without a propellant and generates pressure mechanically.

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

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

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

[0006] WO 2019 / 016409 discloses a container and a nebulizer for spraying a liquid from such a container. The nebulizer includes a fluid pump for drawing doses of liquid from the container and pressurizing each dose for spraying. The container includes an air pump with a piston / cylinder configuration for pressurizing the liquid in the container and assisting in drawing the liquid from the container. A control valve limits the air pressure acting on the liquid.

[0007] However, known inhaler devices or inhaler systems can only be used with replaceable cartridges that are specially adapted to fit into the inhaler. However, it may be desirable to provide a system in which replaceable cartridges of different sizes and filling volumes can be inserted and used, depending on the amount and nature of the medically active liquid or compound contained therein.

[0008] It is therefore an object of the present invention to provide an inhaler system that allows for the use of an interchangeable cartridge system that allows for the storage and administration of different amounts of medically active liquid within the same system. Further objects of the present invention will become apparent based on the following description of the invention, examples and claims. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] European Patent No. 0,627,230 [Patent Document 2] International Publication No. 91 / 14468 Brochure [Patent Document 3] International Publication No. 2018 / 197730 Brochure [Patent Document 4] International Publication No. 2017 / 076938 Brochure [Patent Document 5] International Publication No. 2019 / 016409 Brochure Summary of the Invention

[0010] In a first aspect, the present invention provides an inhalation device system for administering by inhalation a medically active liquid in atomized form, comprising an inhalation device and a replaceable reservoir for holding the medically active liquid; The inhalation device a housing having a storage unit, the storage unit having a connection unit adapted to releasably and fluidly connect to a connection port of the replaceable reservoir, the storage unit adapted to receive the replaceable reservoir and to fluidly connect to the replaceable reservoir; a nozzle for spraying a medically active liquid, and a pump unit disposed within the housing and adapted to be fluidly connected to the reservoir and the nozzle, the pump unit adapted to transport a medically active liquid in a downstream direction from the reservoir to the nozzle; The replaceable reservoir has a total volume of V o and an effective volume V for holding a medically active liquid. e and a connection port adapted to releasably and fluidly connect the cartridge system to a pump unit, wherein the cartridge system has an additional volume V a wherein the extension element is attached to the outer surface of the canister portion.

[0011] In a second aspect, the present invention provides a replaceable cartridge system for holding a medically active liquid for nebulization, preferably adapted for use in an inhaler system according to the first aspect of the invention, the cartridge system having a total volume V o and an effective volume V for holding a medically active liquid. e and a connection unit adapted to releasably and fluidly connect the cartridge system to a pump unit of an inhalation device, wherein the cartridge system has an additional volume V a wherein the extension unit is attached to the outer surface of the container portion.

[0012] In a third aspect, the present invention provides a method for determining a total volume V o 1. A method for providing a replaceable reservoir for an inhalation device system of the first aspect of the invention in the form of a cartridge system having a) a cartridge system having an effective volume V for holding a medically active liquid, the effective volume V being provided with a connection port (preferably in the form of a cap) adapted to releasably and fluidly connect the cartridge system to a pump unit of an inhaler system; e providing a container portion having b) additional volume V a providing an extension element having c) attaching the extension element to the exterior surface of the container portion. [Brief explanation of the drawings]

[0013] [Figure 1] 1 shows a cross-sectional view of an inhaler system with a cartridge inserted into the inhaler.

[0014] [Figure 2] 1 shows a cross-sectional view of an inhaler system with a cartridge inserted into the inhaler, the cartridge including an extension element.

[0015] [Figure 3] 1 shows a replaceable cartridge system with a container portion and an extension element in an exploded state.

[0016] [Figure 4] 4A and 4B show different perspective views of the cartridge system shown in FIG. 3.

[0017] [Figure 5] 1 shows a replaceable cartridge system with a container portion and an extension element in an assembled state.

[0018] [Figure 6] 10A-10C show different cartridge systems with extension elements having enlarged diameters in a disassembled state.

[0019] [Figure 7] 10 shows a different cartridge system having an extension element with an enlarged diameter in an assembled state. DETAILED DESCRIPTION OF THE INVENTION

[0020] In a first aspect, the present invention provides an inhalation device system for administering by inhalation a medically active liquid in aerosol form, comprising an inhalation device and a replaceable reservoir for holding the medically active liquid, the inhalation device comprising: a housing having a storage unit, the storage unit having a connection unit adapted to releasably and fluidly connect to a connection port of the replaceable reservoir, the storage unit adapted to receive the replaceable reservoir and to fluidly connect to the replaceable reservoir; a nozzle for spraying a medically active liquid, and a pump unit disposed within the housing and adapted to be fluidly connected to the reservoir and the nozzle (via the connection unit of the containing unit) and adapted to convey (pressurize, pump) the medically active liquid in a downstream direction from the reservoir to the nozzle; The replaceable reservoir has a total volume of V o and an effective volume V for holding a medically active liquid. e and a connection port (preferably in the form of a cap) adapted to releasably and fluidly connect the cartridge system to a pump unit, wherein the cartridge system provides an additional volume V a wherein the extension element is attached to the outer surface of the container portion.

[0021] The inhalation device system according to the present invention is suitable for inhalation administration of a medically active liquid in aerosol form, and the term "medically active liquid" as used herein refers to a liquid compound or composition that has pharmacological activity or that includes a compound or composition that has pharmacological activity and can ameliorate or prevent symptoms associated with a disease, disorder, or condition, particularly a disease, disorder, or condition of the respiratory system, e.g., a pulmonary disease, disorder, or condition, in a subject, particularly a warm-blooded animal or human, particularly a human. Specific examples of such diseases, disorders, or conditions include, but are not limited to, pulmonary diseases or conditions such as asthma and / or chronic obstructive pulmonary disease (COPD), particularly COPD, or interstitial lung diseases affecting the interstitium of the lungs and lung tissue, e.g., those associated with the airways and / or air sacs (alveoli), e.g., pulmonary fibrosis, e.g., idiopathic pulmonary fibrosis (IPF), interstitial pneumonia, or sarcoidosis.

[0022] 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 subject's lungs, by inhalation of an airstream of a carrier gas containing the medically active liquid in nebulized or aerosolized form. As used herein, the terms "nebulized," "aerosolized," or "atomized" synonymously refer to the state of a medically active liquid in the form of an aerosol having at least two phases: a gas, such as air or another carrier gas, a continuous phase containing a dispersed liquid phase in the form of small droplets, and a liquid phase, i.e., the medically active liquid, which may itself represent a liquid solution, dispersion, suspension, or emulsion. In certain embodiments, such aerosols preferably have respirable particles or droplets, each having a mass median aerodynamic diameter (measured by laser diffraction) of about 10 μm or less, particularly about 7 μm or less, or about 5 μm or less.

[0023] In certain embodiments, the term "medically active liquid" as used herein refers to a medically active liquid in the form of a pharmaceutical composition comprising at least one active pharmaceutical ingredient (API), more particularly at least one inhalable active pharmaceutical ingredient. More specifically, such at least one inhalable active pharmaceutical ingredient may be selected, for example, from long-acting muscarinic antagonists (LAMAs), long-acting beta-agonists (LABAs) and inhalable glucocorticosteroids (ICS), as well as analgesics and antidiabetic agents, either alone or in combination with each other.

[0024] Examples of long-acting muscarinic antagonists (LAMAs) include, but are not limited to, aclidinium bromide, glycopyrronium salts such as glycopyrronium bromide, lebefenacin, tiotropium such as tiotropium bromide, umeclidinium bromide, oxitropium bromide, flutropium bromide, ipratropium bromide, trospium chloride, and tolterodine.

[0025] Examples of long-acting beta agonists (LABA) include, but are not limited to, albuterol, alloformoterol, bambuterol, bitolterol, broxaterol, carbuterol, clenbuterol, fenoterol, formoterol, hexoprenaline, ibuterol, indacaterol, indacterol, isoetharine, isoprenaline, levosalbutamol, mabuterol, melaudrine, metaproterenol, olodaterol, orciprenaline, pirbuterol, procaterol, reproterol, rimiterol, ritodrine, salmeterol, salmefamol, soterenoto, sulfonterol, tialamide, terbutaline, and terbuterol.

[0026] Examples of inhalable glucocorticosteroids (ICS) include, but are not limited to, prednisolone, prednisone, butixocort propionate, flunisolide, beclomethasone, triamcinolone, budesonide, fluticasone, mometasone, ciclesonide, rofleponide, dexamethasone, etiprednisolone dichloroacetate, deflazacort, etiprednol, loteprednol, RPR-106541, NS-126, and ST-26.

[0027] Furthermore, the active pharmaceutical ingredient may be selected from analgesics such as opioid analgesics (e.g., morphine, fentanyl) or non-opioid analgesics (e.g., salicylic acid derivatives, e.g., acetylsalicylic acid) or cannabinoids (e.g., tetrahydrocannabinol), antidiabetic drugs such as insulin.

[0028] The medically active liquid or liquid pharmaceutical composition that can be nebulized or aerosolized by the inhalation device system can contain at least one active pharmaceutical ingredient as described above, but can also contain a mixture of two or more active pharmaceutical ingredients that can be administered by inhalation.

[0029] Medically active liquid or pharmaceutical compositions that can be aerosolized by an inhalation device system according to the present invention are preferably formulated as compositions that are suitable and adapted for use in inhalation, in other words, compositions that can be nebulized or aerosolized for inhalation and that are physiologically acceptable for inhalation by a subject.

[0030] The medically active liquid or pharmaceutical composition that can be administered by the inhalation device system or contained in a corresponding replaceable reservoir can be in the form of a dispersion, for example in the form of a suspension having a liquid continuous phase and a solid dispersed phase, or in the form of a solution.

[0031] In further embodiments, the medically active liquid or pharmaceutical composition may optionally contain one or more physiologically acceptable excipients suitable for use in inhalation. Excipients that may be featured in the composition may include, but are not limited to, one or more buffers for adjusting or controlling the pH of the solution, salts, flavoring agents, surfactants, lipids, antioxidants, and cosolvents, which may be used to enhance or improve solubility, for example, ethanol or glycol.

[0032] In certain embodiments, the medically active liquid may be essentially free of propellants, such as hydrofluoroalkane (HFA) propellants.

[0033] In a further specific embodiment, the medically active liquid may be an aqueous solution, in which one or more active pharmaceutical ingredients are dissolved and solubilized in a liquid carrier solution containing water. Such an aqueous solution may also optionally contain one or more excipients.

[0034] The inhalation device system of the present invention comprises an inhalation device and a replaceable reservoir for holding a medically active liquid. In certain embodiments, the inhalation device of the inhalation device system of the present invention may be a handheld device, i.e., a mobile device that can be conveniently held and used in one hand and is suitable for delivering the above-described nebulized medically active aerosol for inhalation therapy. To be suitable for inhalation therapy, the device must be capable of emitting a medically active aerosol whose particle size is respirable, i.e., small enough to be taken up by the patient's or user's lungs in the above-described range of respirable particles. In this respect, the inhalation device is substantially different from devices that emit sprays for oral or nasal administration, such as those disclosed in U.S. Patent Application Publication No. 2004 / 0068222.

[0035] The inhalation device of the present system includes a housing defining an outer casing of the inhalation device, specifically an outer casing in which further components of the inhalation device are housed and / or attached. The housing can have a user-facing side that can be contacted by a user of the inhalation device, particularly for the inhalation administration described above. In certain embodiments, the user-facing side can be a mouthpiece that can be placed in the user's mouth, particularly for inhalation or administration of the nebulized medically active liquid. Furthermore, the housing can have a removable, or at least partially removable, lower portion, preferably located at the upstream end of the inhalation device, to open the housing and allow access to a storage unit into which a replaceable cartridge can be inserted. As used herein, the term "upstream" refers to a direction or location in relation to the present inhalation device, inhalation device system, cartridge system, or other component, toward which the medically active liquid is delivered by the inhalation device during operation. In contrast, the term "downstream" refers to a direction or location opposite to which the medically active liquid is delivered by the inhalation device during operation. The inhalation device, and more specifically, the housing of the present inhalation device, includes a storage unit adapted to receive a replaceable reservoir or cartridge system, as described in further detail below. The storage unit has a connection unit adapted to releasably and fluidly connect to a connection port of the replaceable reservoir. As used herein, the term "fluidly connect" means, in relation to two elements, that a preferably airtight and / or liquidtight connection is or may be established that allows the transfer of a fluid, such as a gas or liquid, from one element to the other, preferably in such a way that such fluid is completely transferred from one element to the other.

[0036] The storage unit of the housing is adapted to house, or in some embodiments completely house and fluidly connect to, the replaceable reservoir, as described in more detail below, which, particularly with respect to the term "completely housed" as used herein, means that such a replaceable reservoir can be completely installed in the storage unit of the housing, such that the storage unit and the housing can completely enclose or house the replaceable reservoir, preferably such that the surface of the replaceable reservoir when installed in the storage unit is completely enclosed by the housing of the inhalation device.

[0037] The inhalation device of the present system further comprises a nozzle for spraying the medically active liquid. Those skilled in the art are aware of different types of nozzles suitable for spraying, aerosolizing, or atomizing the medically active liquid administered by the present system, such as impingement nozzles, swirl nozzles, orifice nozzles, surface impingement nozzles, or multi-fluid nozzles. However, in certain embodiments, the nozzle of the present inhalation device is impingement type. This means that the nozzle is adapted to emit at least two liquid jets that are directed to collide and break into small aerosol droplets. In certain embodiments, the nozzle is fixed to the housing, particularly the side of the inhalation device housing facing the user, so that it is immobile or immovable relative to the housing, or at least the side or portion of the housing facing the user (e.g., patient), or more specifically, is fixed to the housing, particularly the side facing the user, so that it can be introduced into the user's mouth when the device is used.

[0038] The inhalation device of the system of the present invention further comprises a pump unit disposed within the housing of the inhalation device. The pump unit is adapted to be fluidly connected to the reservoir, particularly via the connection unit of the storage unit. In certain embodiments, the pump unit is fluidly connected to the reservoir via the connection unit of the storage unit. Furthermore, the pump unit is also adapted to be fluidly connected to the nozzle, or in certain embodiments, connected to the nozzle, and further adapted to transport, or in other words pump, the medically active liquid in a downstream direction from the reservoir to the nozzle.

[0039] In certain embodiments, the pump unit included in the inhalation device of the present invention is adapted to deliver nebulized medically active liquid in a discontinuous manner, i.e., in the form of individual units, with one unit delivered per pump cycle. In this aspect, the inhalation device differs from commonly known nebulizers, such as jet nebulizers, ultrasonic nebulizers, vibrating mesh nebulizers, or electrohydrodynamic nebulizers, which generate and deliver nebulized aerosol continuously, typically over a period of several seconds to several minutes, thereby requiring multiple successive breathing maneuvers for the aerosol to be inhaled by the patient or user. Instead, the inhalation device of the present invention is adapted to generate and emit individual aerosol units, each unit corresponding to the amount (i.e., volume) of fluid (i.e., medically active liquid) pumped by the pump unit into the nozzle in one pumping cycle, where it is immediately aerosolized and delivered to the user or patient. Conversely, the amount of liquid pumped by the pump unit in one pumping cycle determines the amount of pharmacologically active agent the patient receives per dose. Therefore, it is very important that the pump unit operates accurately, reliably, and reproducibly with respect to achieving the desired therapeutic effect. Such inhalation devices exhibiting high accuracy and reproducibility, particularly inhalation devices incorporating pump units as described in further detail below, are known to those skilled in the art and are described in International Publication No. 2018 / 197730, the disclosure of which is incorporated herein in its entirety. However, it should be noted that the specific design of the pump unit may vary, and additional pump units, such as those described in U.S. Patent Application Publication No. 2012 / 0090603, which is incorporated herein by reference in its entirety, may also be used in the inhalation devices of the present invention.

[0040] In certain embodiments, the pump unit may also be disposed within the housing and adapted to function as a piston pump, also referred to as a plunger pump, with the riser pipe functioning as a piston or plunger longitudinally movable within a hollow cylinder. The pump unit may have an upstream end fluidly connected to a replaceable reservoir and a downstream end fluidly connected to a nozzle. In further particular embodiments, the pump unit may include a riser pipe adapted to function as a piston within the pump unit, a hollow cylinder, and lockable means for storing potential energy. The lockable means may be capable of storing potential energy when locked and may be adapted to release the stored energy when unlocked, such as a spiral spring or other elastic element. The lockable means may be disposed outside the hollow cylinder and mechanically coupled to it, such that unlocking the means propels the cylinder longitudinally toward the downstream end of the pump unit. The inner segment of such hollow cylinder, through which the upstream end of the riser pipe moves, forms a pump chamber having a variable volume depending on the position of the riser pipe relative to the cylinder.

[0041] The hollow cylinder providing the pump chamber may be fluidly connected, directly or indirectly, to a replaceable reservoir, or more specifically to a connection port of the replaceable reservoir, such as by an optional reservoir pipe (or reservoir pipe section). Similarly, a riser pipe having an internal (upstream) end facing the reservoir and which may be housed within the hollow cylinder, may be fluidly connected, at its downstream or external end, directly or indirectly, in a liquid-tight manner to a nozzle.

[0042] In this context, the expression "hollow cylinder" refers to a part or member that is hollow in the sense that it has a cylindrical shape or includes an internal cavity with a segment having a cylindrical space. In other words, the external shape of the respective part or member does not have to be cylindrical, as is applicable to other types of piston pumps. Furthermore, the expression "hollow cylinder" does not exclude an operating state of the respective part or member in which the "hollow" space can be filled with a material, for example, a liquid to be sprayed.

[0043] As used herein, longitudinal motion is motion along the major axis of the hollow cylinder, and propulsive motion is motion of the portion in the downstream (or forward) direction.

[0044] In certain embodiments, the riser pipe of the pump unit of the inhalation device of the present invention may be disposed downstream of the cylinder and may be rigidly fixed to the user-facing side of the housing so as to be immovable relative to the housing or at least a portion of the housing, including the user-facing side of the housing. For the avoidance of doubt, the term "rigidly fixed" means fixed, directly or indirectly (i.e., via one or more connections), so as to prevent relative movement between the respective parts. Since the nozzle is also preferably immovable relative to the housing or a respective portion of the housing, the riser pipe is also preferably immovable relative to the nozzle, and the pumping action in these embodiments is provided by longitudinal movement of the hollow cylinder. In this embodiment, the forward movement of the cylinder, which is disposed upstream relative to the riser pipe, 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 pipe maintains its position relative to the housing, and the hollow cylinder can change its position relative to the housing, particularly along its longitudinal axis, to perform piston-in-cylinder-type movement of the immovable riser pipe within the movable cylindrical member.

[0045] This arrangement differs from other impingement-type suction devices, such as those disclosed in U.S. Patent Application Publication No. 2012 / 0090603, which rely on a pump unit with a riser pipe in an upstream position and a cylindrical member in a downstream position where the riser pipe is movable and the cylindrical member is fixed to the housing. A key advantage of devices with a fixed riser pipe, such as those described above, is that the passage between the pump chamber and the replaceable reservoir can be designed with fewer restrictions regarding its dimensions. Very large inlet valves (also known as check valves) can be accommodated and are easier to manufacture because they do not need to be accommodated within the narrow riser pipe. Instead, the fixed riser pipe design of the pump unit allows for the use of check valves whose size is limited only by the internal size of the housing or the dimensions of the means for storing potential energy. In other words, the diameters of the valve, riser pipe, and reservoir pipe, if used, do not need to match each other. Furthermore, because this embodiment does not require a movable piston to be connected to the replaceable reservoir, the components that form the fluid connection to the reservoir can be designed independently of the movable component, i.e., the hollow cylinder, allowing each part to be adapted to its individual function. In this regard, the fixed riser pipe design according to this particular embodiment offers greater design flexibility, as the movable hollow cylinder, due to its robust structure and dimensions, offers a better opportunity for designing a mechanically stable connection with the reservoir than a less robust movable riser pipe. Also, in this embodiment, the connection between the hollow cylinder and the replaceable reservoir can be designed with a larger diameter, allowing for faster flow rates and fluid viscosities to be achieved. Furthermore, the support for the replaceable reservoir can be integrated into any component, including the cylinder. Furthermore, in this embodiment, any vent for pressure balancing of the replaceable reservoir can be moved away from the reservoir body itself, for example, to a connector that forms the interface between the replaceable reservoir and the hollow cylinder of the pump unit, thus facilitating construction and avoiding the need for an essentially "open" reservoir body.This is particularly important when the reservoir is designed as a replaceable reservoir, as is the case in the present invention.

[0046] As described above, the lockable means for storing potential energy may be adapted to store energy in its locked state and release the stored energy when unlocked. In certain embodiments, the lockable means is mechanically coupled to the hollow cylinder such that unlocking the means causes the hollow cylinder to move in a propulsive longitudinal direction toward the downstream end of the pump unit. During this movement, the internal volume of the cylinder, i.e., the volume of the pump chamber, decreases. Conversely, when the means for storing potential energy is in the locked state, the hollow cylinder is in its most upstream position where the volume of the pump chamber is greatest. The locked state can also be considered a priming state. When the state of the energy storing means is changed from the unlocked state to the locked state, which may be referred to as priming the device, the hollow cylinder undergoes a repulsive longitudinal movement, i.e., moves from its most downstream position toward its most upstream position. A pumping cycle consists of two subsequent opposing movements of the hollow cylinder, driven by the lockable means for storing potential energy, commencing from its most downstream position to its most upstream (or primed) position and then releasing that energy, and returning to its most downstream position.

[0047] In certain embodiments, the pump unit is a high-pressure pump unit and is adapted to operate or eject fluid at a pressure of at least about 50 bar. In other preferred embodiments, the operating pressure of the pump unit is at least about 10 bar, or at least about 100 bar, or from about 2 bar to about 1000 bar, or from about 50 bar to about 250 bar, respectively. As used herein, the operating pressure is the pressure at which the pump unit ejects the pharmaceutically active liquid to be administered, such as an inhalable aqueous liquid formulation of the pharmaceutically active liquid, from its pump chamber downstream, i.e., toward the nozzle. In this context, the phrase "adapted to operate" means that the components of the pump unit are selected with respect to materials, dimensions, surface quality, and finish to allow operation at the specified pressure.

[0048] Furthermore, such a high pressure pump unit means that the lockable means for storing potential energy is capable of storing and releasing sufficient amounts of energy to drive longitudinal propulsive movement of the cylinder with such force that the respective pressure is obtained.

[0049] The lockable means for storing potential energy may be designed as a tension or pressure spring. Alternatively, a metal or plastic body, or a gaseous medium or magnetic material, may also be used as the energy storage means. Potential energy is supplied to the means by compression or tension. One end of the means may be supported in a housing or within a housing at a suitable position. This end is therefore essentially immobile. The other end may be connected to a hollow cylinder of a pump unit comprising a pump chamber. This end may therefore be essentially movable. The means for storing potential energy may be locked after being charged with a sufficient amount of energy and may store energy until unlocked. Once unlocked, the means may release potential energy (e.g., spring energy) into a cylinder comprising a pump chamber, which is then driven to perform a movement (in this case, longitudinal). Because the energy release typically occurs suddenly, high pressure may build up in the pump chamber before a significant amount of medically active liquid is released, resulting in a pressure drop. In fact, during a significant portion of the release phase, there is an equilibrium between the pressure delivered by the potential energy storage means and the amount of medically active liquid already released. Thus, the amount of medically active liquid remains essentially constant during this phase, which is a significant advantage over devices that use the user's manual force for release, such as those disclosed in US Patent Application Publication Nos. 2005 / 0039738, 2009 / 0216183, 2004 / 0068222, or 2012 / 0298694, because manual force is highly user-dependent and likely to vary significantly during the release phase, resulting in non-uniform droplet formation, size, and volume. In contrast to the prior art, the measures of the present invention ensure that the inhalation device produces highly reproducible results.

[0050] In a further embodiment, the means for storing potential energy may also be provided in the form of a highly pressurized gas container. By proper placement and its repeatable intermittent actuation (i.e., opening), a portion of the energy stored in the gas container can be released into the cylinder. This process can be repeated until the remaining energy is insufficient to re-establish the desired pressure in the pump chamber, after which the gas container must be refilled or replaced.

[0051] In certain embodiments, the lockable means for storing potential energy is a spring having a load of at least 10 N in a deflected state. In preferred embodiments, the means for storing potential energy is a steel compression spring having a load of about 1 N to about 500 N in a deflected state. In other preferred embodiments, the steel compression spring has a load of about 2 N to about 200 N, or about 10 N to about 100 N in a deflected state.

[0052] In one preferred embodiment, a single dose of medication (i.e., a nebulized aerosol of a medically active liquid) is contained in one unit, i.e., the amount delivered from the pump unit to the nozzle to generate the aerosol in one pumping cycle, in which case the user or patient primes and actuates the device only once and inhales the emitted aerosol in one breathing maneuver per dose (i.e., per dosing event).

[0053] In another preferred embodiment, a single dose of medication consists of two units of aerosol, thus requiring two pumping cycles. Typically, the user or patient primes the inhaler, activates the inhaler to release and inhale a unit of aerosol, and then repeats the process. Alternatively, three or more aerosol units may constitute a single dose.

[0054] The volume of fluid (e.g., medically active liquid) pumped by the pump unit of the inhalation device system in one pumping cycle may preferably range from about 0.1 μL to about 1000 μL, or from about 1 μL to about 250 μL, or from about 2 μL to about 150 μL. In particular, the volume may range from about 2 μL to about 50 μL, or from about 5 μL to about 25 μL, more specifically from about 10 μL to about 20 μL, e.g., about 15 μL. These volume ranges are approximately the same as the volume of the liquid phase contained in one unit of aerosol generated by the inhalation device, with slight variations possibly due to minute losses of liquid within the device.

[0055] In a further specific embodiment, the pump unit of the inhalation device includes an inlet valve, also referred to as a check valve or inlet check valve, disposed within the hollow cylinder. According to this embodiment, the interior space of the hollow cylinder, i.e., the pump chamber, is fluidly connected to the fluid reservoir via the inlet check valve. The inlet valve allows the inflow of liquid into the pump chamber but prevents backflow of the medically active liquid into or from the replaceable fluid reservoir. In a preferred embodiment, the inlet valve may be located at or near the upstream end of the cylinder, making substantially the entire interior volume of the hollow cylinder available to function as the pump chamber. Alternatively, it may be more centrally located along the main (longitudinal) axis of the hollow cylinder, defining an upstream segment and a downstream segment of the cylinder, the upstream segment being upstream of the inlet valve and the downstream segment being downstream of the valve. In this case, the pump chamber is located in the downstream segment.

[0056] As mentioned above, one of the advantages of certain embodiments of pump units with fixed or stationary pistons is that a relatively large inlet valve can be accommodated in this position, i.e., at the upstream end of the pump chamber. This is particularly beneficial because it allows for larger fluid conduits within the valve, thus enabling higher fluid velocities to be achieved, resulting in rapid filling of the pump chamber during priming of the inhalation device. Furthermore, this allows for the use of medically active liquids with higher viscosities than typical liquid formulations for inhalation, such as highly concentrated solutions of soluble active ingredients, for inhalation therapy.

[0057] In a further embodiment, 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, exceeds a predetermined threshold value and remain closed as long as the pressure difference remains below the threshold. In this context, the term "pressure difference" means that only the relative pressure difference between the two sides is relevant for determining whether the valve blocks or opens, regardless of the absolute pressure value. For example, if the pressure on the upstream (reservoir) side is already positive (e.g., 1.01 bar due to thermal expansion) but the pressure on the downstream (pump chamber) side is ambient pressure (e.g., 1.0 bar, without device activation), the pressure difference (here, 0.01 bar) is below the threshold value (e.g., 20 mbar), so the valve remains closed even when positive pressure is applied in the opening direction. This means that the check valve remains closed until the threshold pressure is met, thus safely closing the passage between the reservoir and the pump chamber, for example, when the inhalation device is not in use. Examples of threshold pressure differences are in the range of 1 to 1000 mbar, more preferably between about 10 and about 500 mbar, or between about 1 and about 20 mbar.

[0058] When the inhaler of the inhaler system is actuated, the potential energy storing means changes its state from locked to unlocked, releasing energy that causes the cylinder to perform its propulsive longitudinal motion, building up significant pressure in the pump chamber, which creates a significant pressure differential due to the high pressure in the pump chamber and the substantially lower pressure in the fluid reservoir exceeding the pressure differential threshold, resulting in the check valve opening and allowing the pressure chamber to fill with medical fluid from the replaceable reservoir.

[0059] A valve type that can be designed to operate at such a threshold pressure differential is a spring-loaded ball valve. The spring presses the ball into its seat, and the ball valve opens only when the pressure acting on the spring exceeds the spring force. Other valve types that can operate at such a threshold pressure differential, depending on their construction, are duckbill or flap valves.

[0060] The advantage of such a valve operating at a threshold pressure differential is that the reservoir can remain closed until the inhalation device is actively used, thus reducing undesirable splashing of the medically active liquid stored in the cartridge system during device transport or evaporation during long-term storage of the device.

[0061] In a further specific embodiment, the inhalation device of the system according to the present invention may further include an outlet valve inside or at the end of the riser pipe to prevent backflow of liquid or air from the riser pipe into the hollow cylinder. The use of such an outlet valve proves advantageous in many cases. Typically, the downstream end of the riser pipe is located near the nozzle, which is in fluid communication with the outside air. After the amount of medically active liquid delivered from the pump unit through the nozzle in aerosolized form, driven by the longitudinal propulsive movement of the cylinder, the pump chamber must be recharged. To this end, the pump chamber slides back along the riser pipe to its previous upstream position (i.e., performs a repulsive longitudinal movement) so that the internal volume of the pump chamber increases. This generates a relative negative pressure (sometimes referred to as "underpressure") inside the pump chamber, drawing liquid into the pump chamber from a replaceable reservoir located upstream of the pump chamber. However, such a relative negative pressure can also propagate downstream through the riser pipe to the outside of the nozzle, potentially leading to air being sucked into the device through the nozzle or nozzle opening, respectively. This problem can be avoided by providing an outlet valve, also called an outlet check valve, which opens towards the nozzle opening and blocks in the opposite direction.

[0062] Optionally, the outlet valve is of the type that shuts off below (and opens above) a threshold pressure difference, as described in the context of the inlet valve above. If a spring-loaded ball valve is used, the force of the spring must be directed toward 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 value. The advantages of such a valve correspond to the respective advantages described above.

[0063] As mentioned above, the outlet valve may be located within the riser pipe as described above. Alternatively, the suction device is not integrated within the riser pipe, but rather comprises an outlet valve located at or near one end of the riser pipe, particularly at or near its downstream end, for example, at or near a separate connector between the riser pipe and the nozzle. This embodiment may be advantageous in certain cases, for example, when a riser pipe with a particularly small diameter is required, which makes integrating a valve difficult. By accommodating the outlet valve downstream of the riser pipe, a valve with a relatively large diameter can be used, thus simplifying the valve design requirements.

[0064] In a further alternative embodiment, there is no outlet valve. This embodiment may be feasible because the fluid channel of the impingement nozzle can have a relatively small cross-section, resulting in little or very slow backflow of the medically active liquid at given pressure conditions during priming of the inhalation device. If the amount of backflow is deemed acceptable given the particular product application, the inhaler design may be simplified by avoiding the outlet valve.

[0065] In either case, the inhalation device can be designed with or without an outlet valve, and all other options and preferences discussed with respect to other device features are applicable to both of these alternative embodiments.

[0066] The replaceable reservoir for holding the medically active liquid contained in the inhalation device system of the present invention is provided in the form of a cartridge system. The cartridge system of the present invention has a total volume V o The term "total volume" as used herein refers to the accommodation of the entire cartridge system, including all its components, such as the outer wall of the cartridge system. o In typical embodiments, the volume may be selected within the range of about 0.1 mL to about 100 mL, or about 0.1 mL to about 50 mL, or about 0.2 mL to about 30 mL, for example, about 2.5 mL to about 20 mL, or about 5 mL to about 15 mL.

[0067] The replaceable cartridge system of the present invention has an upstream end and a downstream end and has an effective volume V for holding a medically active fluid. e and a connection port adapted to releasably and fluidly connect the cartridge system to a pump unit, in particular via a connection unit of a receiving unit of an inhalation device.

[0068] In a typical embodiment, the container portion of the replaceable cartridge system has an effective volume V selected within a range of about 0.1 to about 50 mL, or about 0.1 mL to about 25 mL, or about 1 mL to about 15 mL, or about 1 to about 10 mL, specifically about 3 mL to about 6 mL, or about 6 mL to about 9 mL, more specifically about 4.0 mL to about 5.0 mL, or about 7.0 mL to about 8.0 mL. e It has.

[0069] In certain embodiments, the connection port of the container portion may be in the form of a cap, such as a cap attached to the downstream end of the container portion. The connection port may have an opening that allows for establishing a fluid connection to the lumen of the container portion and the medically active liquid contained therein. The term "effective volume" refers to the containment of the entire container portion, including all its components, such as the outer wall of the container portion or a connection port, such as a cap. The term "cavity" or "lumen" as used herein in connection with a hollow body, such as a container portion, an extension element, etc., refers to the interior space or cavity inside such a hollow body, regardless of whether such interior space or cavity is completely or only partially surrounded by the outer wall of said hollow body.

[0070] In further specific embodiments, the container portion of the replaceable cartridge system may be in the form of a flexible container, or may be in the form of a rigid, or in other words, dimensionally stable, container. As used herein, the terms "rigid" or "dimensionally stable" mean that the container portion does not change its shape or volume when the medically active liquid contained therein is expelled from the container during standard operation of the inhaler system, or in other words, when the medically active liquid is drawn from the container portion by the pump unit during nebulization and administration of the medically active liquid. In certain embodiments of the inhaler system, the container portion of the replaceable cartridge system is in the form of a dimensionally stable container. In further specific embodiments, the container portion of the replaceable cartridge system is in the form of a dimensionally stable container comprising a flexible or collapsible inner container, as described in more detail below, which contains the medically active liquid to be administered by the inhaler system of the present invention.

[0071] Generally, the container portion, particularly 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 of the present inhalation device system. In certain embodiments, suitable shapes include, but are not limited to, bottle-shaped, tubular, or cylindrical shapes, and symmetrical and asymmetrical shapes can be implemented. In particular, regarding the axial symmetry of the entire container device or cartridge system with respect to the main rotational axis of the container device or cartridge system connecting the center of its upstream end to the center of its downstream end, this can enable advantageous embodiments in which the container device or cartridge system may or may not be inserted into the inhalation device only in a specific orientation. However, in preferred embodiments, the entire inhalation device or cartridge system may have a substantially circular cross-sectional shape so that the container device or cartridge system can be introduced into the inhalation device regardless of the rotational direction about the main longitudinal axis.

[0072] In a further embodiment, the container part may be in the form of a bottle having a (main) opening, preferably at its downstream end, for filling or discharging the medically active liquid to be stored and administered, although it should be noted that the container part may also be provided with further (minor) openings, e.g. for ventilation purposes.

[0073] In further specific embodiments, the extension element of the replaceable cartridge system may be in the form of a rigid, i.e., dimensionally stable, container or hollow body. The terms "rigid" or "dimensionally stable" as used herein in relation to the extension element mean that the extension element does not change its shape or volume during standard operation of the inhaler system, or in other words, when drawn from the container portion by the pump unit during nebulization and administration of the medically active liquid. In specific embodiments of the inhaler system, the extension element of the replaceable cartridge system is in the form of a dimensionally stable hollow body or container.

[0074] In a further particular embodiment, both the container part and the extension element of the replaceable cartridge system are provided in a dimensionally stable form, for example in the form of a dimensionally stable container element or hollow body.

[0075] In general, both the container portion and the extension element 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 of the present inhalation device system, especially when provided in a dimensionally stable form. In certain embodiments, suitable shapes include, but are not limited to, bottle-shaped, tubular, or cylindrical shapes, and symmetrical and asymmetrical shapes can be implemented. In particular, regarding the axial symmetry of the entire container device or cartridge system with respect to the main rotational axis of the container device or cartridge system connecting the center of its upstream end to the center of its downstream end, this can enable advantageous embodiments in which the container device or cartridge system may or may not be inserted into the inhalation device only in a specific orientation. However, in preferred embodiments, the entire inhalation device or cartridge system may have a substantially circular cross-sectional shape so that the container device or cartridge system can be introduced into the inhalation device regardless of the rotational direction about the main longitudinal axis.

[0076] In a further embodiment, the container part may be in the form of a bottle having a (main) opening, preferably at its downstream end, for filling or discharging the medically active liquid to be stored and administered, although it should be noted that the container part may also be provided with further (minor) openings, e.g. for ventilation purposes.

[0077] In further specific embodiments, the extension element and the container portion may be provided independently of each other, particularly in a dimensionally stable form as described above, in the form of a container or hollow body including at least one elastic portion. In this context, the term "elastic" as used herein means that at least a portion of the container or hollow body of the extension element and / or the container portion can be reversibly deformed, particularly by applying an external force to the outer wall of such a container or hollow body, such that the temporarily deformed container or hollow body relaxes back to its original shape after the external force applied to the extension element or container portion is removed. For example, the container portion and / or extension element may be provided in a dimensionally stable form and may include a portion or region that can be deformed by the user, for example, by manually compressing such portion or region of the container portion and / or extension element. This may be useful, for example, for attaching the extension element to the container portion, as described in more detail below.

[0078] In certain embodiments, the reservoir portion and the extension element are provided in a dimensionally stable form and include at least one elastic portion. In other embodiments, both the reservoir portion and the extension element are provided in a dimensionally stable form, with only the reservoir portion or the extension element including at least one elastic portion. Preferably, the reservoir portion and the extension element are provided in a dimensionally stable form, with only the extension element including at least one elastic portion. However, in further embodiments, the reservoir portion and the extension element are provided in a dimensionally stable form, with only the reservoir portion including at least one elastic portion.

[0079] In certain embodiments, the container portion of the replaceable reservoir holds a medically active liquid and has a maximum internal volume V i As used herein with respect to a container portion, an "internal volume" (V iThe term V ) refers to the total internal volume of the container portion that can be filled (partially or completely) with a liquid, in particular with a medically active liquid to be administered by the inhaler system according to the present invention. Thus, the internal volume V of a container portion that is completely filled with a medically active liquid is i corresponds to the volume of medically active liquid contained in such a fully filled container portion. In typical embodiments, the maximum internal volume V i is the effective volume of the container V e and may be selected within the range of preferably 0.1 to about 15 mL, or about 1 to about 10 mL, specifically about 3 mL to about 6 mL, or about 6 mL to about 9 mL, more specifically about 4.0 mL to about 5.0 mL, or about 7.0 mL to about 8.0 mL. However, in further embodiments, the maximum internal volume V of the optional inner container may be selected within the range of i is the effective volume of the container V e may be smaller than 100 mm, resulting in a situation where the entire lumen of the container portion is not filled with the optional inner container.

[0080] For example, the inner container housed in the reservoir portion may be designed to be foldable, such as by having flexible or elastic walls. The advantage of such a design is that during repeated use of the device, including gradually emptying the reservoir, the flexible or elastic walls buckle or collapse, reducing the internal volume of the reservoir, so that the negative pressure required to extract a given amount of liquid does not need to increase substantially over the period of use. In particular, the optional inner container of a replaceable reservoir may be designed as a collapsible bag. The advantage of a collapsible bag is that the pressure inside the reservoir is largely independent of the fill level and the effects of thermal expansion are largely negligible. Furthermore, the structure of such a reservoir type is fairly simple and has already been well established. However, in further embodiments, the inner container may have a non-flexible or rigid form in which pressure equilibrium with the ambient atmosphere during administration of the medical liquid stored therein is achieved by other means, such as an inlet valve or a movable piston.

[0081] The cartridge system of the inhalation device system of the present invention has an additional volume V a In a preferred embodiment, the container portion further comprises an extension element having an effective volume V e and the additional volume of the extension element V a The sum of these is the total volume V of the cartridge system described above. o , specifically in an assembled state as described in more detail below. In certain embodiments, the effective volume V e corresponds to the entire internal volume of the container section, and the additional volume V a corresponds to the entire interior volume of the extension element. In an exemplary embodiment, the additional volume V of the extension element a is the specific overall length L of the cartridge system o and the selected effective volume V of the vessel section e In certain embodiments, the additional volume V of the extension element may be selected within a range of about 0.1 mL to about 100 mL, as needed. a may be selected within the range of about 0.1 mL to about 25 mL, or about 0.1 mL to about 10 mL, or about 0.2 mL to about 5.0 mL, or about 0.5 mL to about 3.5 mL. The extension element may be attached to an outer surface of the container portion, more specifically, as described in more detail below.

[0082] In a further embodiment, the replaceable cartridge system has an overall length L, which corresponds to the length of the replaceable cartridge system measured from the upstream end to the downstream end of the cartridge system in the assembled state, or in other words with the container portion attached to the extension element of the cartridge system. o In a further embodiment, the reservoir portion has an effective length L measured from the upstream end to the downstream end of the reservoir portion. e In yet another embodiment, the extension element has a length L measured from the upstream end to the downstream end of the extension element. a In an exemplary embodiment, the container portion has an effective length L eIn a further exemplary embodiment, the additional length L of the container portion may be selected within a range of about 0.5 cm to about 20 cm, or about 1 cm to about 15 cm, or about 2.5 cm to about 10 cm, or about 4.0 cm to about 8.0 cm. a may be selected within the range of about 0.5 cm to about 19.5 cm, or about 1.5 cm to about 10 cm, or about 2.5 cm to about 5.0 cm.

[0083] In certain embodiments, in the assembled state, i.e., with the extension element attached or mounted to the outer surface of the container element, the overall length L of the resulting replaceable cartridge system is o is the effective length of the container L e and the additional length of the extension element L a It should further be noted that the relative lengths and volumes of the elements of the cartridge system should be understood as corresponding values ​​in the assembled state. In the disassembled state, these values ​​may differ due to any additional components or structures that may be required to attach the elements to one another, as described in more detail below.

[0084] In certain embodiments, the storage unit of the inhalation device may be adapted to receive or completely receive and fluidly connect to a replaceable cartridge system, as described above. In these cases, the storage unit preferably has a defined overall length L o and total volume V o The replaceable reservoir is adapted to receive a replaceable reservoir having a defined overall length L as described above. o and total volume V o In these cases, the replaceable reservoir is provided in the form of a cartridge system having an effective length L e and a container portion having an additional length L a and an extension element having an effective length L of the container portion. e and the additional length of the extension element L a The sum of these is the total length of the cartridge system (assembled) L oIt may be advantageous to be equal to

[0085] This reduces the total length of the assembled cartridge system, L o corresponds to the total length of the cartridge system that can be introduced into and received by the receiving unit of the inhalation device. e Length and extension factor L a This allows for the use of interchangeable cartridge systems in which the length of the cartridge can be varied depending on the specific effective volume required. This allows for the use of cartridges with the same overall length L, such as cartridge systems that hold different medically active liquids or different amounts of a specific medically active liquid. o but with a specific effective length L e the container part and the extension element having a specific additional length L a It may be particularly advantageous if the inhalation device can be used with different cartridge systems having different combinations with extension elements having a volume V. In these cases, the effective volume V depends on the individual amount of medically active liquid to be stored. e It would be advantageous to provide a cartridge system that allows for the adaptation of a medically active liquid to a given volume. Furthermore, it would be advantageous to provide an inhaler system and a corresponding inhaler that offers the possibility of accepting a cartridge system having an effective volume that can be freely selected depending on the medically active liquid or amount thereof to be administered.

[0086] As mentioned above, the extension element may be attached to the outer surface of the container element. As used herein, the terms "attached" or "fixed to" mean that the respective parts are attached or fixed to each other so as to substantially prevent their movement relative to each other during normal operation. In other words, two parts fixed or attached to each other may only move together and may be immovable or immobile relative to each other under normal use conditions. When the extension element is attached or fixed to the container element, this means that the resulting cartridge system can be introduced into at least the storage unit of the inhalation device without disassembling the cartridge system.

[0087] In certain embodiments, the extension element of the cartridge system is permanently attached to the outer surface of the container portion. As used herein in this context, the terms "permanently attached" or "permanently fixed" mean that the extension element is attached to or fixed to the container portion such that the two components cannot be detached or removed from one another without destroying the permanent physical connection between the two components, such that the connection cannot be restored without further technical means, equipment, or other assistance. For example, the permanent connection may be achieved by gluing, welding, or soldering (in the case of metal parts).

[0088] In alternative specific embodiments, the extension element of the cartridge system is removably attached to the outer surface of the container portion, in other words, detachably attached. As used herein, the terms "removably attached" or "removably attached" mean that the physical connection between the container portion and the extension element can be established and released by a user without the use of additional technical means, instruments, or other aids. In certain embodiments, the connection between the container portion and the extension element can be established and reversed only once. In alternative embodiments, the connection between the container portion and the extension element can be established and reversed repeatedly. In further specific embodiments, the extension element can be removed from the container portion without damaging or destroying the extension element, the container portion, or both, so that the connection between the extension element and the container portion can be reestablished, as described in more detail below.

[0089] In certain embodiments, the extension element may be fixed or attached to only a portion of the outer surface or to a connecting structure (such as a sticky or adhesive area, a screw thread or a hook-and-loop element) located on the outer surface of the container part to form a cartridge system of the present invention. In more specific embodiments, the extension element may be attached or fixed to a portion of the outer surface of the container part located at the upstream end of the container part, especially when the container part is provided in the form of a bottle having a (main) opening, preferably at its downstream end, for filling or discharging the medically active liquid to be stored and administered.

[0090] In certain embodiments, the extension element is attached to the outer surface of the container part by a press-fit or form-fit connection, such as a snap-fit ​​connection. In these cases, both the container part and the extension element include corresponding structures or elements, such as rings, protrusions, or corresponding recesses, that allow the form-fit or snap-fit ​​connection to be established. Depending on the physical force required to establish or reverse such a press-fit, form-fit, or snap-fit ​​connection, such a connection may be permanent or reversible, or in other words, removable, as described above. In the case of a substantially reversible, non-permanent connection between the extension element and the container part of the cartridge system, it may be advantageous for the force required to detach and remove the extension element from the outer surface of the container part to be higher than the force required to remove the cartridge system from the storage unit of the inhalation device. This allows, for example, the cartridge system to be removed from the storage unit of the inhalation device by pulling it out of the storage unit, especially when the cartridge system can be introduced or inserted from the upstream end of the inhalation device in a downstream direction along the main longitudinal axis of the inhalation device.

[0091] However, in alternative embodiments, it may be beneficial for the force required to remove the extension element from the container part to be lower than the force required to remove the cartridge system from the storage unit or the connection unit of the inhalation device, respectively, thereby allowing selective removal of the extension element from the storage unit, with the container part remaining in the storage unit of the inhalation device.

[0092] In further exemplary embodiments, the connection between the extension element and the container portion may be established by other reversible fastening means or materials, such as removable adhesive, magnetic forces, hook-and-loop fasteners, screws, threads, luer locks, etc. However, in these embodiments, it may be advantageous for the container portion and / or extension element to be provided in a dimensionally stable form without flexible portions.

[0093] In certain embodiments, the replaceable cartridge system of the inhalation device system (in an assembled state) may have a generally cylindrical shape with a central longitudinal axis connecting the connection port of the container portion located at the downstream end of the cartridge system to the bottom of the cartridge system located at the opposite upstream end of the cartridge system.

[0094] In further particular embodiments, the container portion has an upstream end and a downstream end, the connection port of the container portion may be located at the downstream end of the container portion, and the extension element may be attached to the upstream end of the container portion, preferably by a press-fit, form-fit or snap-fit ​​connection.

[0095] The container portion of the cartridge system can, in certain embodiments, be made or manufactured from a polymeric material, specifically a thermoplastic polymer such as polyethylene, polypropylene, polyoxymethylene (POM), polystyrene, etc. In alternative embodiments, the container portion may be made from a metal, such as stainless steel, aluminum, or other suitable metal or mixtures thereof. However, in preferred embodiments, the container portion is made from polyethylene or polypropylene, preferably polypropylene. However, it should be noted that separate structures of the container portion, such as a connection port, preferably in the form of a cap, may be formed from the same or another metallic or non-metallic material as described above.

[0096] In certain embodiments, the extension unit of the cartridge system can have substantially the same cross-sectional diameter as the container portion of the cartridge system, particularly with respect to the upstream end of the container portion and the downstream end of the extension element. This is particularly beneficial when the two elements are attached or secured to one another by a form-fit, press-fit, or snap-fit ​​connection. However, further embodiments are possible in which the container portion has a smaller cross-sectional diameter than the extension element, for example, when the container portion is attached or secured to the extension element by introduction (e.g., at the upstream end of the container portion) into an opening (e.g., at the downstream end) of the extension element. In further embodiments, the opposite configuration is possible in which the container portion has a larger cross-sectional diameter than the extension element, for example, when the container portion is attached or secured to the extension element by introduction (e.g., at the downstream end) of the container portion into an opening (e.g., at the upstream end) of the container portion.

[0097] In general, the cartridge system may have a symmetrical or asymmetrical cross-sectional shape. An asymmetrical cross-section may be advantageous when it is important that the cartridge system can only be introduced into or accommodated in the accommodation unit of the inhalation device in a specific orientation. On the other hand, it may be beneficial for the cartridge system to have a symmetrical cross-section, such as a circular cross-section (perpendicular to the main central axis connecting the downstream end with the upstream end of the replaceable cartridge system), particularly to facilitate insertion of the cartridge system for infants or disabled users. Thus, in certain embodiments, both the extension element and the container portion of the cartridge system have circular cross-sections. In further embodiments, the container portion and / or extension element may have a constant diameter throughout, resulting in a cylindrical cartridge after assembly. However, in alternative embodiments, the container unit and / or extension element may have other cylindrical shapes with varying diameters, particularly in the case of an extension element that can widen in diameter toward its upstream end.

[0098] In certain embodiments, the extension element of the cartridge system also has an upstream end (i.e., corresponding to the upstream end of the cartridge system) and a downstream end, and may have an opening at the downstream end, with the opening having an inner diameter corresponding to the outer diameter of the upstream end of the container portion. As outlined above, particularly when the extension element is attached to the container portion by a form-fit or snap-fit ​​connection, it may be advantageous for additional structures, such as corresponding protrusions or recesses, to be provided on the contact surface. In further embodiments where the extension element is attached to the container portion by a press-fit connection, it may be advantageous for such additional structures not to be present. For example, when the upstream end of the container portion is inserted into the corresponding opening at the downstream end of the extension element, such opening has an inner diameter that matches the outer diameter of the (upstream end) of the container portion.

[0099] The extension element may, in certain embodiments, be made from the same material as described above for the container element, or from a different material. In either case, however, the extension element may be made from a polymer material, in particular a thermoplastic polymer such as polyethylene, polypropylene, polyoxymethylene (POM), polystyrene, etc. In certain embodiments, it may be advantageous to use polyethylene or polypropylene, in particular polypropylene.

[0100] In certain embodiments, the extension element of the cartridge system may be a hollow body having a hollow space or lumen, or may be a filled body without an internal space. However, in preferred embodiments, the extension element of the cartridge system may be a hollow body having at least one internal space or cavity housed therein. In these cases, particularly when the container portion is provided in the form of a (substantially) sealed container and the extension element is provided in the form of a hollow body having a hollow internal space, the resulting cartridge system includes at least two separate spaces or compartments within the cartridge system that allow for the storage of different components of the inhalation device system. Furthermore, in further embodiments, for example, the extension element may include two or more separate hollow spaces or cavities.

[0101] In certain embodiments, at least one interior space or cavity may include additional elements of a functional or non-functional nature. In this context, the term "functional element" as used herein means an element that is necessary for or enables the extension element or cartridge system to perform a function other than storage of the medically active liquid dispensed by the inhalation device system.

[0102] In certain embodiments, the extension element may be a hollow body without any functional elements contained therein. However, in alternative embodiments, the extension element of the cartridge system may include one or more functional elements housed within the extension element's internal space. In exemplary, non-limiting embodiments, such functional elements may be selected from the group consisting of an indicator device, a blocking mechanism, an electronic interface such as a Bluetooth interface, an electronic coding system, an electronic data logger, a coding element such as an RFID tag or chip, a pressure reservoir, a command means, a visualization element, an electromechanical interface, a display, and the like. In particular, if the internal space or cavity of the extension element contains an indicator device, a blocking element, or an equivalent function, the internal space may also contain mechanical elements such as a gear unit, a drive element such as a drive shaft, gears, a push button, and the like. This allows for efficient use of the space or volume corresponding to the internal space or lumen of the extension element, often allowing for the introduction of additional functionality into the inhaler system, preferably a handheld inhaler system, without the need to increase its overall size.

[0103] On the other hand, it may be advantageous for the extension element to not include a functional element, particularly if the extension element may be exposed to potentially damaging conditions, such as exposure to reactive gases or radiation during sterilization. Thus, in certain embodiments, the extension element of the cartridge system does not include a functional element, particularly an electronic device or interface. In further specific embodiments, the extension element does not include or house an indicator device for counting the number of uses of the inhalation device or replaceable reservoir.

[0104] In the preferred embodiments described above, the extension element is a hollow body having an internal space or lumen opening on one side, specifically the downstream end of the extension element, and is adapted to be permanently or removably fixed or attached to the container element holding the medically active liquid to be administered. Thus, in certain embodiments, the extension element, more specifically the internal space of the extension element, does not contain the medically active liquid or another compound to be administered. In further specific embodiments, the extension element of the cartridge system has a vent opening for connecting the internal space or lumen of the extension element to the ambient atmosphere when attached to the outer surface of the container portion. This can be advantageous, particularly if the cartridge system is sterilized before being filled with the medically active liquid, since the cartridge system, or more specifically the container portion and the extension element, can be assembled, attached, or fixed to each other before filling the container portion with the medically active liquid, especially if the sterilization is performed by exposure to a reactive gas such as ethylene oxide, ozone, or other gas suitable for sterilization. Thus, in certain embodiments, the container portion and the extension element are assembled and sterilized before filling the cartridge system with the medically active liquid.

[0105] As outlined above, the cartridge system has a usable volume V e and the additional volume V of the extension element a In an exemplary embodiment, the extension element has an additional volume V a Effective volume V of the container e The ratio of is in the range of about 20:1 to about 1:20, specifically about 10:1 to about 1:10, or about 5:1 to about 1:5, or about 2.5:1 to about 1:2.5, or about 2:1 to about 1:1. As also outlined above, the cartridge system may have an effective length L of the container portion. e and the additional length of the extension element L a In an exemplary embodiment, the effective length L e and the additional length of the extension element L ais in the range of about 20:1 to about 1:20, specifically about 10:1 to about 1:10, or about 5:1 to about 1:5, or about 2.5:1 to about 1:2.5, or about 2:1 to about 1:1.

[0106] A further advantage of the present inhaler system is that it has a total length L o and volume V o A cartridge system having the same overall length L o and volume V o The advantage of this modular design is that it can be replaced with a corresponding (standard) cartridge, i.e., a cartridge containing only the container element, that does not include the extension element. This modular design allows for maximum flexibility in terms of compatibility of the inhaler system, and more particularly, the inhaler of the system, as the inhaler may or may not be used with a standard replacement cartridge of a specified length and volume that does not include a removable or non-removable extension element. Thus, in certain embodiments of the inhaler system, the cartridge system can be replaced with a cartridge system without an extension element.

[0107] In further embodiments, the replaceable cartridge system may also be attached to the housing of the inhalation device, more specifically, to a part of the housing. For example, the cartridge system may be attached or fixed to a removable lower part of the housing. More specifically, the replaceable cartridge system may be attached to the lower part of the housing via an extension element. This connection may be established, for example, between the outer surface of the extension element and the inner surface of the housing, particularly the inner surface of the removable lower part of the housing, where the term "inner surface" refers to the surface facing the interior of the housing or the inhalation device. The optional connection between the replaceable cartridge system and the housing, particularly the lower part of the housing, of the extension element of the cartridge system may be permanent or removable. Thus, in some embodiments, the extension element of the cartridge system may be removably attached to the housing of the inhalation device, such as by a press-fit or form-fit connection as described above. In alternative embodiments, the extension element of the cartridge system may be permanently attached or fixed to the housing, preferably to a removable part of the housing.

[0108] However, in preferred embodiments, the extension element may be removably attached to the inhalation device housing. This may be advantageous because it allows for the replacement of a particular extension element, i.e., an extension element having a particular additional length and volume, with another extension element having a different additional length and volume as may be required to fit a container portion of a given size. Again, this allows for a modular design of the inhalation device system that can operate with different cartridge systems and container portions adapted to the amount and nature of the medically active liquid stored therein.

[0109] In a further preferred embodiment, in which the extension element is removably attached to both the receptacle unit and the housing, in particular to the removable lower part of the housing, it may be advantageous for the force required to remove the extension element from the receptacle part and to remove or disconnect the extension element from the housing to be greater than the force required to remove the cartridge system from the storage part of the inhalation device, thereby making it possible to remove the entire cartridge system from the storage unit by removing the removable part of the housing from the inhalation device in a single operation.

[0110] However, in alternative embodiments, it may also be advantageous for the force required to remove or disconnect the extension element from the housing to be lower than the force required to remove the extension element from the container portion and the force required to remove the cartridge system from the storage unit of the inhalation device. This makes it possible to remove the removable portion of the housing from the inhalation device without removing the cartridge system from the storage unit of the inhalation device. In further alternative embodiments, it may be advantageous for the force required to remove the extension unit from the container portion to be lower than the force required to remove the container portion from the connection unit of the storage unit and the force required to separate or disconnect the extension unit from the removable portion of the housing. In these embodiments, it is possible to remove the removable portion of the housing together with the extension unit, but in the case of the inhalation device, without removing the container portion from the storage unit.

[0111] In a second aspect, the present invention provides a replaceable cartridge system for holding a medically active liquid for nebulization, preferably adapted for use in an inhaler system according to the first aspect of the invention, the cartridge system having a total volume V o and an effective volume V for holding a medically active liquid. e and a connection unit adapted to releasably and fluidly connect the cartridge system to a pump unit of an inhalation device, wherein the cartridge system has an additional volume Va In a preferred embodiment of this second aspect of the invention, the cartridge system further comprises an extension element having an effective volume V e and the additional volume of the extension element V a The sum of these is the total volume of the cartridge system (when assembled) V o is equal to.

[0112] In certain embodiments, the replaceable cartridge system of this second aspect of the invention is particularly suitable as a replaceable reservoir included in an inhaler system according to the first aspect of the invention.

[0113] It should be noted that all embodiments, features and ranges described above in relation to the first aspect of the invention, as well as all preferred features, embodiments, ranges, and combinations thereof, may be applied to or combined with the second aspect of the invention and all further aspects of the invention accordingly.

[0114] In a third aspect, the present invention provides a method for determining a total volume V o 1. A method for providing a replaceable reservoir for an inhalation device system of the first aspect of the invention in the form of a cartridge system, in particular in the form of a replaceable cartridge system of the second aspect of the invention, comprising: a) a cartridge system having an effective volume V for holding a medically active liquid, the effective volume V being provided with a connection port (preferably in the form of a cap) adapted to releasably and fluidly connect the cartridge system to a pump unit of an inhaler system; e providing a container portion having b) additional volume V a and preferably providing an extension element having an effective volume V of the container portion. e and the additional volume of the extension element V a The sum of these is the total volume of the cartridge system (when assembled) V o providing a step equal to, and c) attaching the extension element to the exterior surface of the container portion.

[0115] According to step a) of the method of this aspect of the invention, a cartridge system is provided with a usable volume V for holding a medically active liquid, the cartridge system being provided with a connection port (preferably in the form of a cap) adapted to releasably and fluidly connect the cartridge system to a pump unit of an inhaler system. e A container portion having:

[0116] In a preferred embodiment of this third aspect of the invention, the container part is provided in the form of a dimensionally stable container, more particularly in the form of a stable hollow body or container having at its downstream end a connection port (adapted to releasably and fluidly connect the cartridge system to a pump unit of an inhaler system) and at its opposite upstream end a surface part adapted to releasably or permanently connect, preferably releasably, to an extension element.

[0117] According to step b), the additional volume V a and preferably has an extension element having an effective volume V e and the additional volume of the extension element V a The sum of these is the total volume of the cartridge system (when assembled) V o is equal to.

[0118] In a further embodiment of this aspect of the invention, the extension element is provided in the form of a dimensionally stable hollow body, preferably having an opening or other connection means at its downstream end. As described in detail above in relation to the inhalation device system of the first aspect of the invention, the extension element can have, for example, an opening or another surface area having fastening means adapted for releasably or permanently connecting, preferably releasably, to the container portion. In a preferred embodiment, this opening or other fastening means is located at the downstream end of the extension element.

[0119] According to step c) of this aspect of the invention, the extension element is attached to the outer surface of the container portion. In certain embodiments, the extension element is releasably attached to the outer surface of the container portion, for example, by contacting an opening or other connection means on the surface of the extension element with a corresponding surface portion or connection means on the container portion. In certain embodiments, the fastening means of the extension element may be manually pressed onto the corresponding fastening means or outer surface of the container portion. However, in alternative embodiments, the extension element may be threaded into a corresponding thread on the outer surface of the container portion.

[0120] In a further particular embodiment, the method of this aspect of the invention further comprises the additional step a1) after step a), followed by step b):

[0121] a1) introducing the container part into the storage unit of the inhaler system of the first aspect of the present invention and optionally connecting the connection port of the container part to the pump unit of the inhaler system;

[0122] In this embodiment, the method further comprises the additional step b1) following step b) and then step c). b1) further comprising the step of introducing the extension element into the receiving unit of the inhalation device.

[0123] Detailed Description of the Drawings 1 shows an inhalation device system 10 comprising an inhalation device 20 and a replaceable reservoir in the form of a cartridge system 30 (different elements of the cartridge system are not shown) that is inserted into the inhalation device. The inhalation device 20 has a housing 21 with a lower portion 22 that can be separated and removed from the inhalation device 20 to open the housing 21 and allow access to a storage unit 23 into which the replaceable cartridge system 30 can be inserted. The storage unit 23 further has a connection unit 24 adapted for releasable and fluid connection to a connection port 32 of the replaceable reservoir.

[0124] The inhalation device (20) further comprises a nozzle (25) disposed at the downstream end of the inhalation device for spraying the medically active liquid. The inhalation device further comprises a pump unit (40) disposed within the housing (21). As described in detail above, the pump unit is fluidly connected to the reservoir (via the connection unit (24) of the containing unit (23)) and the nozzle (25) and is adapted to pump the medically active liquid in a downstream direction from the reservoir (30) to the nozzle (25).

[0125] The pump unit (40) has an upstream end (41) fluidly connected to the replaceable reservoir (30) and a downstream end (42) fluidly connected to the nozzle (25), and the pump unit (40) further comprises: (i) a riser pipe (43) having an upstream end (44), the riser pipe (43) adapted to function as a piston within the pump unit (40) and fixedly secured to the user-facing (downstream) side of the housing (21) so as to be immovable relative to the housing (21); and (ii) a hollow cylinder (45) located upstream of the riser pipe (43), the upstream end of the riser pipe (43) being inserted into the cylinder (45) so that the cylinder (45) is longitudinally movable on the riser pipe (44).

[0126] As also shown in FIG. 1 , pump unit (40) includes (iii) lockable means for storing potential energy (46) when locked and releasing the stored energy when unlocked, the means (46) being disposed outside cylinder (41) and mechanically coupled to cylinder (45), such that unlocking of the means (46) causes longitudinal propulsive movement of cylinder (45) toward the downstream end of pump unit (42).

[0127] In Figure 2, the inhaler system 10 is shown with the same inhaler 20, but from a different angle, and the reference numerals of the elements described in Figure 1 have been omitted. As can be seen herein, the inhaler housing 21 includes a cap 26 that is located at and covers the downstream end 27, i.e., the side of the housing that faces the user, when in a closed state. The housing 21 further includes a removable lower portion 22 located at the opposite upstream end of the inhaler. When removed from the inhaler, the removable lower portion 22 of the housing allows access to a storage unit 23 into which the cartridge system 30 can be inserted or removed by movement along the main longitudinal axis A. See Figure 4.

[0128] As also shown in Figure 2, the replaceable reservoir (30) in the form of a cartridge system has a container portion (31) with a connection port (32) in the form of a cap. The container portion (31) may also have an inner container (not shown), such as a flexible bag, capable of holding a medically active liquid. The connection port (32) is adapted to releasably and fluidly connect the cartridge system (30) to a pump unit (40). The cartridge system (30) of the inhaler system (10) further comprises an extension element (33) attached to the outer surface of the container portion (31), more particularly to the upstream end (34) of the container portion. As can be seen in Figure 2, the effective length L of the container portion (31) is e and the additional length L of the extension element (33) a The sum of these is the total length L of the cartridge system (30) when assembled as shown in the figure. o , which in this case corresponds to the overall length of the cartridge shown in Figure 1. As also shown in Figure 2, the container portion (31) has an effective volume V e and the extension element (33) has an additional volume V a and the effective volume V of the container portion (31) e and the additional volume V of the extension element (33) a The sum of these is the total volume V of the assembled cartridge system (30). oAdditionally, FIG. 2 (like FIG. 1) shows an inlet check valve (47) located at the upstream end of the hollow cylinder.

[0129] 3 shows a side view of the replaceable cartridge system (30) in a disassembled state or before assembly, respectively. The cartridge system (30) has a container portion (31) with a connection port or unit (32) in the form of a cap located and attached to the downstream end (35) of the container portion (31). The container portion has a generally cylindrical shape. In the example shown, the upstream end (34) of the container portion narrows in diameter and has a protrusion (36) for establishing a connection to the extension element (33) by form-fitting or snap-fitting.

[0130] FIG. 4 shows a perspective view of the cartridge system 30 of FIG. 3 , with a connection port or unit 32 in the form of a cap positioned and attached to the downstream end 35 of the container portion 31, either before or after assembly. As can be seen, the extension element 33 is in the form of a hollow body having an opening 37 at the downstream end of the extension element 33 and a lumen, space, or cavity 39b. On the inner surface of the extension element 33, in the illustrated example, the opening 37 of the extension element is surrounded by a recess 38, establishing a form or snap-fit ​​connection to a corresponding protrusion 36 of the container portion 31. It should be noted, however, that in the reverse configuration, the container portion can be provided in the recess and the extension element can be provided in the corresponding protrusion. In either case, the connection can be established, for example, by manually pressing the opening 37, or, in other words, the downstream end of the extension element 33 at the upstream end 34 of the container portion 31. It should be noted that, depending on the specific shape and configuration of the projections (36) and recesses (38), they may establish a shape or snap-fit ​​connection that is permanent or that can be reversed, for example, by manually removing or pulling the extension element (33) from the container portion (31). As also seen in FIG. 4, the extension element has a small vent opening (39) that establishes a fluid connection between the lumen (39b) of the extension element (33) and the ambient atmosphere after assembly of the cartridge system (30). Additionally, FIG. 4 shows a major longitudinal axis (A) that connects the center of the downstream end of the cartridge system in the form of the cap (32) with the center of the upstream end of the cartridge system, more specifically, with the center of the upstream end of the extension element (33).

[0131] Figure 5 shows the effective length L e The container part (31) has a connection port or unit (32) in the form of a cap (32) having an additional length L a1 shows the assembled cartridge system (30) attached or secured to an extension element (33) having a vent opening (39). As can be seen, in this example, the resulting cartridge system (30) has a generally cylindrical shape with the container portion (31) and extension element (33) having the same diameter. The vent opening (39) allows the assembled cartridge system (30) to be sterilized by gas sterilization before filling the container portion (31) or inner container, if present, with a medically active liquid, respectively.

[0132] 6 shows another example of a cartridge system 30 having an extension element 33 with an enlarged diameter in the disassembled state. In this example, the extension element 33 has a diameter at its downstream end that corresponds to the diameter of the upstream end 34 of the reservoir portion 31 for establishing a form-fit or snap-fit ​​connection. In this example, the extension element 33 has a larger additional volume V (compared to an extension element 33 having the same diameter as the reservoir portion 31) due in part to the enlarged diameter. a This may be advantageous in particular when one or more functional elements such as indicator devices, blocking mechanisms, electronic interfaces, electronic code systems, electronic data loggers, code elements, pressure reservoirs, indicating means, etc. are arranged within the extension element (33). The illustrated extension element (33) further has a further opening in the form of a window (39a) allowing physical or visual access to functional elements optionally arranged in the extension element (33).

[0133] FIG. 7 shows the cartridge system (30) of FIG. 6 in an assembled state. [Explanation of symbols]

[0134] 10. Inhalation Device System 20 Inhaler 21 Housing 22 Lower part of housing 23 Containment Unit 24 connection units 25 nozzles 26 Cap 30 Interchangeable Cartridge System 31 Container part 32 connection port 33 Extension element 34 Upstream end of vessel section 35 Downstream end of vessel section 36 Protrusion 37 Extension element opening 38 depression 39 Ventilation opening 39a Window 39b Inner space, lumen of extension element 40 Pump Unit 41 Upstream end of pump unit 42 downstream end of pump unit 43 Riser Pipe 44 Upstream end of riser pipe 45 Hollow cylinder of pump unit 46 Lockable means for storing potential energy 47 Inlet check valve A Cartridge system center axis L e Effective length of the container L a Additional length of extension element L o Cartridge system overall length V e Effective volume of the container V a Additional volume of extension elements V o Total volume of the cartridge system

[0135] Below is a list of numbered embodiments E1-E30 included in the present invention.

[0136] E1 An inhalation device system (10) for administering by inhalation a medically active liquid in aerosol form, comprising an inhalation device (20) and a replaceable reservoir (30) for holding the medically active liquid; The inhalation device (20) a housing (21) having a storage unit (23), the storage unit having a connection unit (24) adapted to releasably and fluidly connect to a connection port (31) of a replaceable reservoir (30), the storage unit (24) adapted to receive the replaceable reservoir (30) and to fluidly connect to the replaceable reservoir (30); a nozzle (25) for spraying a medically active liquid, and a pump unit (40) disposed within the housing (21) and adapted to be fluidly connected to the reservoir (30) and the nozzle (25), and adapted to transport a medically active liquid in a downstream direction from the reservoir (30) to the nozzle (25); The replaceable reservoir (30) has a total volume V o and an effective volume V for holding a medically active liquid. e and a connection port (32) adapted to releasably and fluidly connect the cartridge system (30) to a pump unit (40), wherein the cartridge system (30) has an additional volume V a The inhaler system (10) further comprises an extension element (33) having a first end (34) and a second end (35) attached to the outer surface of the container portion (31).

[0137] E2 Effective volume V of the container part (31) e and the additional volume V of the extension element (33) a The sum of these is the total volume V of the cartridge system (30). o The inhalation device system (10) of embodiment E1, wherein

[0138] E3 The container portion (31) of the replaceable reservoir (30) holds a medically active liquid and has a maximum volume V i An inhalation device system (10) according to any one of embodiments E1 or E2, comprising an inner container having:

[0139] E4 An inhalation device system (10) according to any one of embodiments E1 to E3, wherein the inner container of the container portion (31) is provided in the form of a bag, in particular in the form of a foldable bag.

[0140] E5 An inhalation device system (10) according to any one of embodiments E1 to E4, wherein the reservoir portion (31) is provided in a dimensionally stable form.

[0141] E6 An inhalation device system (10) according to any one of embodiments E1 to E5, wherein the extension element (33) is provided in a dimensionally stable form.

[0142] E7 An inhalation device system (10) according to any one of embodiments E1 to E6, wherein the container portion (31) and the extension element (33) are provided in a dimensionally stable configuration.

[0143] E8 An inhalation device system (10) according to any one of embodiments E1 to E7, wherein the container portion (31) comprises at least one elastic portion.

[0144] E9 An inhalation device system (10) according to any one of embodiments E1 to E8, wherein the extension element (33) comprises at least one elastic portion.

[0145] E9 An inhalation device system (10) according to any one of embodiments E1 to E8, wherein the extension element (33) and the container portion (31) comprise at least one elastic portion.

[0146] E10 An inhalation device system (10) according to any one of embodiments E1 to E9, wherein the extension element and the container portion are provided in a dimensionally stable form, and the extension element and the container portion comprise at least one elastic portion.

[0147] E11 The accommodation unit (23) has a specified total length L o and total volume V o The replaceable reservoir (30) is adapted to receive and fluidly connect with a replaceable reservoir (30) having a defined overall length L o and total volume V o An inhalation device system (10) according to any one of embodiments E1 to E10, provided in the form of a cartridge system having:

[0148] E12 The replaceable reservoir (30) has an effective length L e and a container portion (31) having an additional length L a and an extension element (33) having an effective length L of the container portion (31). e and the additional length L of the extension element (33) a The sum of these is the total length L of the cartridge system (30) (in the assembled state). o An inhalation device system according to any one of embodiments E1 to E11, wherein

[0149] E13 An inhalation device system (10) according to any one of embodiments E1 to E12, wherein the extension element (33) of the cartridge system (30) is removably attached to the outer surface of the container portion (31).

[0150] E14 An inhalation device system (10) according to any one of embodiments E1 to E13, wherein the extension element (33) is attached to only a portion of the outer surface of the container portion.

[0151] E15 An inhalation device system (10) according to any one of embodiments E1 to E14, wherein the extension element (33) is attached to a part of the outer surface of the container portion (31) located at the upstream end of the container portion.

[0152] E16 An inhalation device system (10) according to any one of embodiments E13 to E15, wherein the force required to remove the extension element (33) from the outer surface of the container portion (31) is higher than the force required to remove the cartridge system (30) from the storage unit (23) of the inhalation device (20).

[0153] E17 The inhalation device system (10) according to any one of embodiments E1 to E12, wherein the extension element (33) of the cartridge system (30) is permanently attached to the outer surface of the container portion (31).

[0154] E18 An inhalation device system (10) described in any one of embodiments E1 to 17, wherein the replaceable cartridge system (30) (in assembled state) has a cylindrical shape with a central longitudinal axis (A) connecting the connection port (32) of the container portion (31) located at the downstream end of the cartridge system (30) with the bottom of the cartridge system (30) located at the opposite upstream end of the cartridge system (30).

[0155] E19 An inhalation device system (10) according to any one of embodiments E1 to E18, wherein the container portion (31) has an upstream end (34) and a downstream end (35), the connection port (32) is located at the downstream end (34) of the container portion (31), and the extension element (33) is attached to the upstream end (35) of the container portion.

[0156] E20 The inhalation device system (10) of any one of embodiments E1 to E19, wherein the extension element (33) is attached to the outer surface of the container portion (31) by a press-fit or form-fit connection.

[0157] E21 An inhalation device system (10) according to any one of embodiments E1 to E20, wherein the extension element (33) has substantially the same cross-sectional diameter as the container portion (31) of the cartridge system (30).

[0158] E22 An inhalation device system (10) according to any one of embodiments E1 to E21, wherein the extension element (33) and the container portion (31) of the cartridge system (30) have a circular cross section.

[0159] E23 An inhalation device system (10) according to any one of embodiments E1 to E22, wherein the extension element (33) has an opening (37) at its downstream end, the opening having a diameter corresponding to the (outside) diameter of the upstream end (34) of the container part.

[0160] E24 An inhalation device system (10) according to any one of embodiments E1 to E23, wherein the extension element (33) of the cartridge system (30) is a hollow body without any functional element contained therein.

[0161] E25 An inhalation device system (10) according to any one of embodiments E1 to E24, wherein the extension element (33) does not contain any medically active liquid or other compound to be administered.

[0162] E26 An inhalation device system (10) according to any one of embodiments E1 to E25, wherein the extension element (33) of the cartridge system (30) has a ventilation opening (39) to the ambient atmosphere (to the lumen of the extension element (33)) when attached to the outer surface of the container portion (31).

[0163] E27 An inhalation device system (10) according to any one of embodiments E1 to E26, wherein the container portion (31) and the extension element (33) are assembled and sterilized before filling the cartridge system (30) with the medically active liquid.

[0164] E28 The inhalation device system of any one of embodiments E1 to E27, wherein the extension element (33) comprises a functional element housed in an inner cavity of the extension element (33).

[0165] E29 The inhalation device system (10) of embodiments E1 to E28, wherein the functional element is selected from an indicator device, a blocking mechanism, an electronic interface, an electronic encoding system, an electronic data logger, an encoding element, a pressure reservoir, and an indicating means.

[0166] E30 An inhalation device system (10) according to any one of embodiments E1 to E29, wherein the extension element (33) of the cartridge system (30) does not comprise an indicator device for counting the number of uses of the inhalation device or the replaceable reservoir.

[0167] E31 The replaceable cartridge (30) has a total volume V selected within the range of about 0.2 mL to about 30 mL. o The inhalation device system (10) of any one of embodiments E1 to E30, comprising:

[0168] E32 The container portion (31) of the replaceable cartridge system (30) has a usable volume V selected within a range of about 1 mL to about 15 mL, or about 1 to about 10 mL, specifically about 3 mL to about 6 mL, or about 6 mL to about 9 mL, more specifically about 4.0 mL to about 5.0 mL, or about 7.0 mL to about 8.0 mL. e The inhalation device system (10) of any one of embodiments E1 to E31, comprising:

[0169] E33 The additional volume V of the extension element (33) a The inhalation device system (10) of any one of embodiments E1 to E32, wherein the volume of the solution may be selected within the range of about 0.1 ml to about 25 mL, or about 0.2 mL to about 5.0 mL, or about 0.5 mL to about 3.5 mL.

[0170] E34 An inhalation device system (10) according to any one of embodiments E1 to E33, wherein the cartridge system (30) can be replaced with a cartridge system without an extension element.

[0171] E35 A pump unit (40) of the suction device (20) an upstream end fluidly connected to a replaceable reservoir (30); a downstream end fluidly connected to a nozzle (25); The pump unit is (i) a riser pipe (43) having an upstream end, adapted to function as a piston in a pump unit; a riser pipe (43) fixedly secured to the side of the housing (21) facing the user so as to be immovable relative to the housing (21); and (ii) An inhalation device (10) as described in embodiments E1 to E34, further comprising a hollow cylinder (41) located upstream of the riser pipe (44), wherein the upstream end of the riser pipe (43) is inserted into the cylinder (41) so that the cylinder (41) is longitudinally movable on the riser pipe (43).

[0172] E36 The pump unit (40) (iii) An inhalation device system (10) as described in embodiment 35, comprising: (iii) a lockable means for storing potential energy (46) when locked and releasing the stored energy when unlocked, the means (46) being arranged outside the cylinder (41) and mechanically coupled to the cylinder (41), and unlocking the means (46) causes longitudinal propulsive movement of the cylinder (41) towards the downstream end of the pump unit.

[0173] E37 A replaceable cartridge system (30) for holding a medically active liquid for nebulization and adapted for use in an inhaler system (10) according to any of embodiments E1 to E36, wherein the cartridge system (30) has a total volume V o and an effective volume V for holding a medically active liquid. eand a connection unit (24) adapted to releasably and fluidly connect the cartridge system (30) to a pump unit (40) of the inhalation device (20), wherein the cartridge system (30) has an additional volume V a The cartridge system (30) further comprises an extension element (33) having a

[0174] E38 Effective volume V of the container part (31) e and the additional volume V of the extension element (33) a The sum of these is the total volume V of the cartridge system (30) (in the assembled state). o The replaceable cartridge system of embodiment E37, which is equal to

[0175] E39 The shape of the cartridge system, specifically the overall volume V o A method for providing a replaceable reservoir for an inhalation device system according to any one of embodiments E1 to E36 in the form of a replaceable cartridge system according to embodiment 37 or 38, comprising: a) a cartridge system having an effective volume V for holding a medically active liquid, the effective volume V being provided with a connection port (preferably in the form of a cap) adapted to releasably and fluidly connect the cartridge system to a pump unit of an inhaler system; e providing a container portion having b) additional volume V a and preferably providing an extension element having an effective volume V of the container portion. e and the additional volume of the extension element V a The sum of these is the total volume of the cartridge system (when assembled) V o providing a step equal to, and c) attaching the extension element to an exterior surface of the container portion.

[0176] E40 39. The method of embodiment 39, comprising: a1) A method further comprising the step of introducing a container part into a storage unit of an inhaler system of the first aspect of the present invention and optionally connecting a connection port of the container part to a pump unit of the inhaler system.

[0177] E41 41. The method of embodiment 40, comprising: b1) The method further comprising the step of introducing an extension element into the storage unit of the inhalation device.

Claims

1. An inhalation device system (10) for inhalation administration of a medically active liquid in aerosol form, comprising an inhalation device (20) and a replaceable reservoir (30) for holding said medically active liquid; The inhalation device (20) a housing (21) having a storage unit (23), the storage unit having a connection unit (24) adapted for releasable fluid connection to a connection port (31) of the replaceable reservoir (30), the storage unit (24) adapted to receive the replaceable reservoir (30) and to be fluidly connected to the replaceable reservoir (30); a nozzle (25) for spraying said medically active liquid, and a pump unit (40) disposed within said housing (21), adapted to be fluidly connected to said reservoir (30) and said nozzle (25), and adapted to transport said medically active liquid in a downstream direction from said reservoir (30) to said nozzle (25); The replaceable reservoir (30) has a total volume (V ｏ ) and has an effective volume (V) for holding said medically active liquid. ｅ ) and a connection port (32) adapted to releasably and fluidly connect said cartridge system (30) to said pump unit (40), said cartridge system (30) having an additional volume (V ａ ) wherein the extension element (33) is attached to the outer surface of the container portion (31).

2. The effective volume V of the container portion (31) ｅ and the additional volume V of the extension element (33). ａ The sum of these is the total volume V of the cartridge system (30). ｏ 2. The inhaler system (10) of claim 1, wherein the inhaler system (10) is equal to:

3. The container portion (31) of the replaceable reservoir (30) holds the medically active liquid and has a maximum volume V ｉ 3. An inhalation device system (10) according to claim 1 or 2, comprising an inner container having:

4. 4. An inhaler system (10) according to any one of claims 1 to 3, wherein the inner container of the container part (31) is provided in the form of a bag, in particular in the form of a foldable bag.

5. The storage unit (23) has a specified overall length L ｏ and total volume V ｏ and adapted to receive and fluidly connect a replaceable reservoir (30) having a defined overall length L ｏ and total volume V ｏ 5. An inhaler system (10) according to any one of claims 1 to 4, provided in the form of a cartridge system having:

6. The replaceable reservoir (30) has an effective length L ｅ and a container portion (31) having an additional length L ａ and an extension element (33) having the effective length L of the container portion (31). ｅ and the additional length L of the extension element (33). ａ The sum of these is the total length L of the cartridge system (30) (in the assembled state). ｏ 6. The inhalation device system of claim 1, wherein the inhalation device system is equal to:

7. 7. The inhaler system (10) according to any one of claims 1 to 6, wherein the extension element (33) of the cartridge system (30) is removably attached to the outer surface of the container portion (31).

8. 8. The inhalation device system (10) of claim 7, wherein the force required to remove the extension element (33) from the outer surface of the container portion (31) is greater than the force required to remove the cartridge system (30) from the storage unit (23) of the inhalation device (20).

9. 7. The inhaler system (10) according to any one of claims 1 to 6, wherein the extension element (33) of the cartridge system (30) is permanently attached to the outer surface of the container part (31).

10. 10. An inhaler system (10) according to any one of claims 1 to 9, wherein the container part (31) is provided in a dimensionally stable form.

11. 11. An inhaler system (10) according to any one of claims 1 to 10, wherein the extension element (33) is provided in a dimensionally stable form.

12. 12. The inhaler system (10) according to any one of claims 1 to 11, wherein the extension element (33) comprises at least one elastic portion.

13. 13. The inhaler system (10) according to any one of claims 1 to 12, wherein the extension element (33) is attached to a part of the outer surface of the container part (31) located at the upstream end of the container part.

14. An inhalation device system (10) as described in any one of claims 1 to 13, wherein the replaceable cartridge system (30) (in the assembled state) has a cylindrical shape having a central longitudinal axis (A) connecting the connection port (32) of the container portion (31) located at the downstream end of the cartridge system (30) with the bottom of the cartridge system (30) located at the opposite upstream end of the cartridge system (30).

15. 15. An inhalation device system (10) according to any one of claims 1 to 14, wherein the container portion (31) has an upstream end (34) and a downstream end (35), the connection port (32) is located at the downstream end (34) of the container portion (31), and the extension element (33) is attached to the upstream end (35) of the container portion.

16. 16. The inhaler system (10) according to any one of the preceding claims, wherein the extension element (33) is attached to the outer surface of the container part (31) by a press-fit or form-fit connection.

17. 17. An inhaler system (10) according to any one of claims 1 to 16, wherein the extension element (33) has substantially the same cross-sectional diameter as the container portion (31) of the cartridge system (30).

18. 18. An inhalation device system (10) according to any one of claims 1 to 17, wherein the extension element (33) and the container portion (31) of the cartridge system (30) have a circular cross section.

19. 19. An inhalation device system (10) according to any one of claims 1 to 18, wherein the extension element (33) has an opening (37) at the downstream end, the opening having a diameter corresponding to the (outside) diameter of the upstream end (34) of the container portion.

20. 20. An inhaler system (10) according to any one of claims 1 to 19, wherein the extension element (33) of the cartridge system (30) is a hollow body with no functional elements contained therein.

21. 21. An inhalation device system (10) according to any one of claims 1 to 20, wherein the extension element (33) does not contain the medically active liquid or other compound to be administered.

22. An inhalation device system (10) as described in any one of claims 1 to 21, wherein the extension element (33) of the cartridge system (30) has a ventilation opening (39) to the ambient atmosphere (to the inner cavity of the extension element (33)) when attached to the outer surface of the container portion (31).

23. 23. The inhaler system (10) of any one of claims 1 to 22, wherein the container part (31) and the extension element (33) are assembled and sterilized before filling the cartridge system (30) with the medically active liquid.

24. 24. An inhalation device system according to any one of claims 1 to 19 and 21 to 23, wherein the extension element (33) comprises a functional element housed in the lumen of the extension element (33).

25. 25. The inhaler system (10) of claim 24, wherein the functional element is selected from an indicator device, a blocking mechanism, an electronic interface, an electronic encoding system, an electronic data logger, a coding element, a pressure reservoir, and an indicating means.

26. An inhalation device system (10) as described in any one of claims 1 to 25, wherein the extension element (33) of the cartridge system (30) does not include an indicator device for counting the number of uses of the inhalation device or replaceable reservoir.

27. The replaceable cartridge (30) has a total volume V selected within the range of about 0.2 mL to about 30 mL. ｏ 27. An inhalation device system (10) according to any one of claims 1 to 26, comprising:

28. The container portion (31) of the replaceable cartridge system (30) has an effective volume V selected within the range of about 0.1 to about 15 mL. ｅ 28. An inhalation device system (10) according to any one of claims 1 to 27, comprising:

29. The additional volume V of the extension element (33) ａ The inhalation device system (10) of any one of claims 1 to 28, wherein the volume of the inhaler may be selected within the range of about 0.1 ml to about 25 mL.

30. 30. The inhaler system (10) of any one of claims 1 to 29, wherein the cartridge system (30) is replaceable with a cartridge system without an extension element.

31. The pump unit (40) of the suction device (20) an upstream end fluidly connected to said replaceable reservoir (30); a downstream end fluidly connected to the nozzle (25); The pump unit comprises: (i) a riser pipe (43) having an upstream end, adapted to function as a piston within said pump unit; a riser pipe (43) fixedly secured to the side of the housing (21) facing the user so as to be immovable relative to the housing (21); and 31. The inhaler system (10) of any one of claims 1 to 30, further comprising: (ii) a hollow cylinder (41) located upstream of the riser pipe (44), the upstream end of the riser pipe (43) being inserted into the cylinder (41) such that the cylinder (41) is longitudinally movable on the riser pipe (43).

32. The pump unit (40) 32. The inhaler system (10) of claim 31, further comprising: (iii) lockable means (46) for storing potential energy (46) when locked and releasing the stored energy when unlocked, the lockable means (46) being located outside the cylinder (41) and mechanically coupled to the cylinder (41), such that unlocking the means (46) causes longitudinal propulsive movement of the cylinder (41) towards the downstream end of the pump unit.

33. 33. A replaceable cartridge system (30) for holding a medically active liquid for nebulization and adapted for use in an inhaler system (10) according to any one of claims 1 to 32, said cartridge system (30) having a total volume V ｏ and an effective volume V for holding said medically active liquid. ｅ and a connection unit (24) adapted to releasably and fluidly connect said cartridge system (30) to said pump unit (40) of an inhalation device (20), said cartridge system (30) comprising an additional volume V ａ wherein the extension element (33) is attached to the outer surface of the container portion (31).

34. The effective volume V of the container portion (31) ｅ and the additional volume V of the extension element (33). ａ The sum of these gives the total volume V of the cartridge system (30) (in the assembled state). ｏ 34. The replaceable cartridge system of claim 33, wherein:

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