Inhalation device system

Abstract

The present invention provides an inhalation device system for inhalation administration of a medically active liquid in a spray form, the system 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 for releasable fluid connection to a connection port of the replaceable reservoir, the storage unit adapted to store the replaceable reservoir and to be fluidly connected to the replaceable reservoir, a nozzle for spraying the medically active liquid, and a pump unit disposed within the housing and adapted to be fluidly connected to the reservoir (via the connection unit of the storage unit) and to the nozzle, and adapted to convey (pressurize, pump) the medically active liquid in a downstream direction from the reservoir to the nozzle.

Description

[Technical Field]

[0001] The present invention relates to the field of inhalation devices for medically active liquids. In particular, the present invention relates to an inhalation device system comprising an inhalation device and a replaceable reservoir for holding a medically active liquid, wherein the replaceable reservoir is 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. In particular, such devices are used in medicine and therapy, where they function as inhalation devices for applying active ingredients in the form of aerosols, i.e., small droplets embedded in a gas. Such inhalation devices are known, for example, from European Patent No. 0,627,230. 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 spray 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 supplies it to the nozzle. The pumping device operates without propellant and generates pressure mechanically.

[0003] Known embodiments of such suction devices are presented, for example, in International Publication No. 91 / 14468. In such devices, the pressure in a pump chamber connected to a housing is generated by the movement of a movable hollow piston. The piston is movably positioned inside a stationary cylinder or pump chamber. An inlet located upstream of the hollow piston is fluidly connected to the inside of a reservoir (i.e., the reservoir tube portion). The tip located downstream leads to the pump chamber. A check valve is also located inside the tip of the piston to prevent backflow of fluid into the reservoir.

[0004] Further inhalation devices are known from International Publication No. 2018 / 197730. The handheld inhalation device disclosed herein includes a housing having a side facing the user, an impact nozzle for generating a spray aerosol by the impact of at least two liquid jets, the nozzle being firmly attached to the user-facing side of the housing so as to be immovable relative to the housing, a fluid reservoir located within the housing, and a pump unit located within the housing, the pump unit having an upstream end fluid-connected to the fluid reservoir and a downstream end fluid-connected to the nozzle. The pump unit includes a riser pipe adapted to pump fluid from the fluid reservoir to the nozzle and adapted to function as a piston of the pump unit, and firmly fixed to the user-facing side of the housing so as to be immovable relative to the housing.

[0005] International Publication No. 2017 / 076938 discloses a system with a nebulizer, as well as a container with fluid and an indicator device for such a nebulizer. A check mechanism 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 performed or still possible with the current container.

[0006] International Publication No. 2019 / 016409 discloses a container and a nebulizer for spraying liquid from such a container. The nebulizer comprises a fluid pump for drawing a dose of liquid from the container and pressurizing each dose for spraying. The container comprises an air pump having a piston / cylinder configuration for pressurizing the liquid in the container to help draw the liquid from the container. A control valve limits the air pressure acting on the liquid.

[0007] However, known inhalation devices or inhalation device systems can only be used with replaceable cartridges that are specially fitted to the inhalation device. However, depending on the amount and properties of the medically active liquid or medically active compound contained therein, it may be desirable to provide a system that can be used by inserting replaceable cartridges of different sizes and volumes.

[0008] Therefore, an object of the present invention is to provide an inhalation device system that enables the use of a replaceable cartridge system that allows for the storage and administration of different amounts of medically active liquids within the same system. Further objects of the present invention will become apparent based on the following description, examples and claims of the present invention. [Prior art documents] [Patent Documents]

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

[0010] In a first aspect, the present invention relates to an inhalation device system for administering a medically active liquid in spray form by inhalation, comprising an inhalation device and a replaceable reservoir for holding the medically active liquid, The inhalation device is A housing having a housing unit, the housing unit having a connection unit adapted to be openable and fluidly connected to a connection port of a replaceable reservoir, the housing receiving a replaceable reservoir and adapted to be fluidly connected to a replaceable reservoir, A nozzle for spraying medically active liquids, and The system comprises a pump unit, which is housed within a housing and adapted to be fluidly connected to a reservoir and nozzle, and adapted to transport a medically active fluid downstream from the reservoir to the nozzle, The replaceable reservoir has a total volume of V o It has an effective volume V for holding a medically active liquid. e The cartridge system is provided in the form of a container portion having a container portion and a connection port adapted to allow the cartridge system to be opened and fluidly connected to a pump unit, the cartridge system having an additional volume V a The present invention relates to an inhalation device system further comprising an extension element having a portion attached to the outer surface of the container portion.

[0011] In a second aspect, the present invention relates to a replaceable cartridge system for holding a medically active liquid for spraying, which is preferably adapted for use in an inhalation device system according to a first aspect of the present invention, wherein the cartridge system has a total volume V o It has an effective volume V for holding a medically active liquid. e The cartridge system comprises a container portion having an additional volume V, and a connection unit adapted to allow the cartridge system to be releasably and fluidly connected to the pump unit of the suction device, wherein the cartridge system has an additional volume V a The cartridge system further comprises an extension element having the extension unit, which is attached to the outer surface of the container portion.

[0012] In a third aspect, the present invention relates to the total volume V o A method for providing a replaceable reservoir for an inhalation device system of a first embodiment of the present invention in the form of a cartridge system having, a) providing a container portion having an effective volume V e for holding a medically active liquid, the container portion comprising a connection port (preferably in the form of a cap) adapted releasably and fluidly connect the cartridge system to a pump unit of an inhalation device system, b) providing an extension element having an additional volume V a , and c) attaching the extension element to an outer surface of the container portion. The present invention relates to a method comprising the steps of: BRIEF DESCRIPTION OF THE DRAWINGS

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

[0014] [Figure 2] 2 shows a cross-sectional view of an inhalation device system with a cartridge inserted into the inhalation device, wherein the cartridge comprises an extension element.

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

[0016] [Figure 4] 4 shows a different perspective view of the cartridge system shown in FIG. 3.

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

[0018] [Figure 6] 6 shows a different cartridge system having an extension element with an enlarged diameter in an exploded state.

[0019] [Figure 7] 7 shows a different cartridge system having an extension element with an enlarged diameter in an assembled state. [Modes for carrying out the invention]

[0020] In a first aspect, the present invention relates to an inhalation device system for administering a medically active liquid in spray form by inhalation, comprising an inhalation device and a replaceable reservoir for holding the medically active liquid, the inhalation device is A housing having a housing unit, the housing unit having a connection unit adapted to be openable and fluidly connected to a connection port of a replaceable reservoir, the housing receiving a replaceable reservoir and adapted to be fluidly connected to a replaceable reservoir, A nozzle for spraying medically active liquids, and It comprises a pump unit positioned within the housing and adapted to be fluidly connected to the reservoir and nozzle (via a connecting unit of the housing unit), and adapted to transport (pressurize, pump) a medically active fluid downstream from the reservoir to the nozzle, The replaceable reservoir has a total volume of V o It has an effective volume V for holding a medically active liquid. e The cartridge system is provided in the form of a container portion having a container portion and a connection port (preferably in the form of a cap) adapted to allow the cartridge system to be opened and fluidly connected to a pump unit, the cartridge system having an additional volume V a The present invention relates to an inhalation device system further comprising an extension element having a portion attached to the outer surface of the container portion.

[0021] The inhalation device system according to the present invention is suitable for the inhalation administration of medically active liquids in spray form, and as used herein, the term “medically active liquid” means a liquid compound or composition having pharmacological activity or having pharmacological activity that can improve or prevent symptoms associated with diseases, disorders or conditions of subjects, particularly warm-blooded animals or humans, particularly humans, particularly diseases, disorders or conditions of the respiratory system, e.g., lung diseases, disorders or conditions. Specific examples of such diseases, disorders or conditions include, but are not limited to, asthma and / or chronic obstructive pulmonary disease (COPD), particularly COPD, or interstitial lung diseases affecting the interstitium of the lungs and lung tissue, e.g., those relating to the airways and / or air sacs (alveoli), e.g., pulmonary fibrosis, e.g., idiopathic pulmonary fibrosis (IPF), interstitial pneumonia, or lung diseases or conditions such as sarcoidosis.

[0022] Furthermore, as used herein, the term “inhalation administration” refers to an administration route in which a medically active liquid is delivered to the respiratory system, particularly the lower respiratory system such as the lungs of the subject, by inhalation by the subject of an airflow of another carrier gas containing the medically active liquid in the form of a spray or aerosol. As used herein, the terms “sprayed,” “aerosolized,” or “atomized” are synonymous with a state of a medically active liquid that exists in the form of an aerosol having at least two phases: a gas such as air or another carrier gas, which comprises a continuous phase containing a dispersed liquid phase in the form of small droplets, and a liquid phase which itself may represent a liquid solution, dispersion, suspension, or emulsion, i.e., the medically active liquid. In certain embodiments, such an aerosol preferably has breathable particles or droplets having an aerodynamic mass median 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 specifically, at least one inhalable active pharmaceutical ingredient. More specifically, such at least one inhalable active pharmaceutical ingredient may be selected, for example, alone or in combination with long-acting muscarinic antagonists (LAMAs), long-acting beta-agonists (LABAs), and inhalable glucocorticosteroids (ICS), as well as analgesics and antidiabetic agents.

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

[0025] Examples of long-acting beta-agonists (LABAs) include, but are not limited to, albuterol, alloformoterol, bambuterol, bitolterol, broxaterol, carbuterol, clenbuterol, fenoterol, formoterol, hexoprenaline, ibuterol, indacaterol, indacterol, isoetaline, isoprenaline, levosalbutamol, mabuterol, meladoline, metaproterenol, orodaterol, orciprenaline, pirbuterol, procaterol, reproterol, limiterol, ritodrine, salmeterol, salmefamol, soterenoto, sulfonterol, thiaramdo, 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, lofreponide, 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), or antidiabetic drugs such as insulin.

[0028] The medically active liquid or liquid pharmaceutical composition that can be sprayed or aerosolized by this inhalation device system may contain at least one of the above-mentioned active pharmaceutical ingredients, but may also contain a mixture of two or more active pharmaceutical ingredients that can be administered by inhalation.

[0029] The medically active liquid or pharmaceutical composition that can be aerosolized by the inhalation device system according to the present invention is preferably formulated as a composition suitable and adapted for use by inhalation, in other words, a composition that can be atomized or aerosolized for inhalation and is physiologically acceptable for inhalation by the subject.

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

[0031] In further embodiments, the above-described medically active liquid or pharmaceutical composition may optionally contain one or more physiologically acceptable excipients suitable for inhalation use. Excipients that may be featured in the composition may include, but are not limited to, one or more buffers 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 above-mentioned medically active liquid may not inherently contain propellants such as hydrofluoroalkane (HFA) propellants.

[0033] In further specific embodiments, the above-mentioned medically active liquid may be an aqueous solution in which one or more of the above-mentioned 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 of the above-mentioned 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, in other words, a mobile device that can be conveniently held and used with one hand and is suitable for delivering a medically active aerosol sprayed as described above for inhalation therapy. To be suitable for inhalation therapy, the device must be able to release a medically active aerosol whose particle size is breathable, i.e., breathable particles within the range described above, small enough to be taken into the lungs of the patient or user. In this respect, the inhalation device is substantially different from devices that release sprays for oral or nasal administration, such as those disclosed in U.S. Patent Application Publication No. 2004 / 0068222.

[0035] The inhalation device of this system comprises a housing that defines an outer casing for the inhalation device, specifically an outer casing that houses and / or mounts further components of the inhalation device. The housing may have a user-facing side that can be touched by the user of the inhalation device, particularly for the inhalation administration described above. In certain embodiments, the user-facing side may be a mouthpiece that can be placed in the user's mouth, particularly for the inhalation or administration of a sprayed medically active liquid. Furthermore, the housing may have a lower section, preferably located at the upstream end of the inhalation device, that is removable and at least partially removable, in order to open the housing and allow access to a housing unit into which a replaceable cartridge can be inserted. As used herein, “upstream” means the direction or location in which the medically active liquid is delivered by the inhalation device during operation with respect to the inhalation device, the inhalation device system, the cartridge system, or other components. In contrast, as used herein, “downstream” means the opposite direction or location in which the medically active liquid is delivered by the inhalation device during operation. The inhalation device, more specifically the housing of the inhalation device, comprises a housing unit adapted to receive a replaceable reservoir or cartridge system, as will be described in more detail below. The housing unit has a connection unit adapted to be openable and fluidly connected to a connection port of a replaceable reservoir. As used herein, the term “fluidly connected” means, with respect to two elements, a preferably airtight and / or liquid-tight connection is established, or may be established, that allows the transfer of a fluid, preferably such as a gas or liquid, from one element to the other, preferably in a manner that allows such fluid to be completely transferred from one element to the other.

[0036] The housing unit of the housing is adapted to house a replaceable reservoir, or in some embodiments, to fully house and fluidize it, as will be described in more detail below. This means that, with respect to the term “fully housed” as used herein, such a replaceable reservoir can be fully introduced into the housing unit of the housing, preferably so that the surface of the replaceable reservoir is fully sealed by the housing of the suction device when introduced into the housing unit, so that the housing unit and housing can fully seal or house the replaceable reservoir.

[0037] The inhalation device of the system of the present invention further comprises a nozzle for spraying a 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 system of the present invention, such as impingement nozzles, swirling nozzles, orifice nozzles, surface impingement nozzles, or multifluid nozzles. However, in certain embodiments, the nozzle of the inhalation device is impingement type. This means that the nozzle is adapted to release at least two liquid jets directed to impinge and break down into small aerosol droplets. In certain embodiments, the nozzle is fixed firmly to the housing, particularly the user-facing side of the housing of the inhalation device, so as to be immovable or immovable relative to the housing, or at least relative to the side or portion of the housing facing the user (e.g., the patient), or more specifically, so as to be introduced into the user's mouth when the device is used.

[0038] The suction device of the system of the present invention further comprises a pump unit located within the housing of the suction device. The pump unit is specifically adapted to be fluidly connected to a reservoir via a connecting unit of the housing unit. In certain embodiments, the pump unit is fluidly connected to a reservoir via a connecting unit of the housing unit. Furthermore, the pump unit is also adapted to be fluidly connected to a nozzle, or in certain embodiments, connected to a nozzle and further adapted to transport, in other words, pump a medically active fluid downstream 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 a sprayed medically active liquid in a discontinuous manner, i.e., in the form of individual units, with one unit delivered per pump cycle. In this embodiment, the inhalation device generates and delivers a sprayed aerosol continuously over a period typically ranging from a few seconds to several minutes, and as a result, the aerosol differs from commonly known nebulizers such as jet nebulizers, ultrasonic nebulizers, vibrating mesh nebulizers, or electrohydrodynamic nebulizers, which require numerous continuous breathing operations for inhalation by the patient or user. Instead, the inhalation device of the present invention is adapted to generate and release individual aerosol units, each unit corresponding to the amount (i.e., volume) of fluid (i.e., medically active liquid) pumped into the nozzle by the pump unit in a single 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 a single pumping cycle determines the amount of pharmacologically active drug the patient receives with each dose. Therefore, it is extremely important that the pump unit operates accurately, reliably, and reproducibly in relation to achieving the desired therapeutic effect. Such inhalation devices exhibiting high precision and reproducibility, specifically inhalation devices incorporating pump units as described in more 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 by reference in its entirety. However, it should be noted that the specific design of the pump unit may be modified, and further pump units, such as the unit 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 housed within a housing and may be adapted to function as a piston pump, also known as a plunger pump, where the riser pipe functions as a longitudinally movable piston or plunger 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 specific embodiments, the pump unit may comprise a riser pipe which can be adapted to function as a piston within the pump unit, a hollow cylinder, and a lockable means for storing potential energy. The lockable means can store 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 located outside the hollow cylinder and mechanically coupled to the hollow cylinder such that when the means is unlocked, the cylinder moves longitudinally toward the downstream end of the pump unit. The inner segment of such a hollow cylinder on which the upstream end of such a riser pipe moves forms a pump chamber having a variable volume depending on the position of the riser pipe relative to the cylinder.

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

[0042] In this context, the term "hollow cylinder" refers to a part or component that is hollow in the sense that it has a cylindrical shape or contains an internal void with a segment having a cylindrical space. In other words, the external shape of each part or component does not need to be cylindrical, as is applicable to other types of piston pumps. Furthermore, the term "hollow cylinder" does not preclude the operating state of each part or component in which the "hollow" space may be filled with material, such as a sprayed liquid.

[0043] As used herein, longitudinal motion is motion along the main axis of a hollow cylinder, and propulsion motion is motion of the downstream (or forward) portion.

[0044] In certain embodiments, the riser pipe of the pump unit of the suction device of the present invention may be located downstream of the cylinder and may be firmly fixed to the user-facing side of the housing so as to be immobile with respect to the housing or at least a portion of the housing, including the user-facing side of the housing. To avoid misunderstanding, the term “firmly fixed” means to be 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 immobile with respect to the housing or each portion of the housing, the riser pipe is also preferably immobile with respect to the nozzle, and the pumping action is brought about in these embodiments by the longitudinal movement of the hollow cylinder. In this embodiment, the propulsive motion of the cylinder, which is located upstream of the riser pipe, results in a decrease in the volume of the pump chamber, and the repulsive motion of the cylinder results in an increase in the volume. In other words, in these embodiments, the riser pipe maintains its position relative to the housing, and the hollow cylinder can change its position relative to the housing, particularly along its longitudinal axis, to perform in-cylinder piston-like movement of the immobile riser pipe within a movable cylindrical member.

[0045] This arrangement differs from other impingement suction devices, such as those disclosed in U.S. Patent Application Publication No. 2012 / 0090603, in which the riser pipe is located upstream in the pump unit, and the riser pipe is movable and the cylindrical member is fixed to the housing in the downstream position. A key advantage of devices with a fixed riser pipe as described above is that the passage between the pump chamber and the replaceable reservoir can be designed with fewer constraints in terms of its dimensions. Very large inlet valves (also called check valves) can be accommodated, and are easier to manufacture because they do not need to be housed in a narrow riser pipe. Instead, the fixed riser pipe design of the pump unit allows the use of check valves whose size is limited only by the internal size of the housing or the dimensions of the means for storing potential energy. In other words, the diameters of the valve, riser pipe, and reservoir pipe, if used, do not need to match each other. Furthermore, in this embodiment, since the movable piston does not need to be connected to the replaceable reservoir, the components making up the fluid connection to the reservoir can be designed independently of the movable components, i.e., the hollow cylinder, and the individual parts can be made to fit their respective individual functions. In this respect, the fixed riser pipe design according to this particular embodiment offers greater design flexibility because the movable hollow cylinder, due to its robust structure and dimensions, provides a better opportunity to design 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 to enable faster flow velocities and fluid viscosities. Furthermore, the support for the replaceable reservoir can be integrated with any component including the cylinder. Moreover, in this embodiment, any vent for pressure equilibrium of the replaceable reservoir can be moved away from the reservoir body itself, for example, to a connector forming the interface between the replaceable reservoir and the hollow cylinder of the pump unit, thus simplifying the structure and avoiding the need to provide an essentially "open" reservoir body.This is particularly important when the reservoir is designed as a replaceable reservoir, as in the present invention.

[0046] As described above, a 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 a hollow cylinder such that when the means is unlocked, the hollow cylinder moves longitudinally 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 locked, the hollow cylinder is at its upstream position where the volume of the pump chamber is maximum. The locked state can also be thought of as a priming state. When the state of the energy storage means changes from an unlocked state, which may be called priming of the device, to a locked state, the hollow cylinder moves in a repulsive longitudinal motion, i.e., from its furthest downstream position toward its furthest upstream position. The pumping cycle consists of two subsequent opposing movements of the hollow cylinder, starting from its most downstream position to its most upstream (or primed) position, then driven by a lockable means for storing potential energy that releases 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 at or discharge 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 about 2 bar to about 1000 bar, or about 50 bar to about 250 bar, respectively. As used herein, operating pressure is the pressure at which the pump unit discharges a administered pharmaceutically active liquid, such as an aspirable aqueous liquid formulation of a pharmaceutically active liquid, downstream from its pump chamber, i.e., toward the nozzle. In this context, the expression “adapted to operate” means that the components of the pump unit are selected with respect to materials, dimensions, surface quality and finish so as to enable operation at a specified pressure.

[0048] Furthermore, such a high-pressure pump unit means that the lockable means for storing potential energy can store and release enough energy to drive the longitudinal propulsive motion of the cylinder with a force such that the respective pressures are obtained.

[0049] The lockable means for storing potential energy may be designed as a tension or compression spring. Alternatively, in addition to a metal or plastic body, a gaseous medium or a magnetic material can also be used as an energy storage means. The potential energy is supplied to the means by compression or tension. One end of the means may be supported in or within a housing at a suitable position. Thus, this end is essentially immovable. The other end may be connected to a hollow cylinder of a pump unit having a pump chamber. Thus, this end may be essentially movable. The means for storing potential energy can be locked after a sufficient amount of energy has been loaded and can store energy until unlocking occurs. Once unlocked, the means can release the potential energy (e.g., spring energy) into the cylinder having the pump chamber, which is then driven to perform motion (in this case, longitudinally). Typically, the energy release occurs abruptly, so high pressure may build up in the pump chamber before a considerable amount of medically active fluid is released, causing the pressure to drop. In fact, for a considerable 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 fluid already released. Thus, the amount of medically active fluid remains essentially constant during this phase, which is a significant advantage for devices that use the user's manual force for release, such as those disclosed in U.S. Patent Application Publication No. 2005 / 0039738, U.S. Patent Application Publication No. 2009 / 0216183, U.S. Patent Application Publication No. 2004 / 0068222, or U.S. Patent Application Publication No. 2012 / 0298694, because manual force depends on the individual user or patient and is very likely to vary greatly during the release phase, resulting in non-uniform droplet formation, size, and volume. In contrast to the prior art, the means according to the present invention ensure that the inhalation device produces highly reproducible results.

[0050] In further embodiments, means for storing potential energy may also be provided in the form of a highly pressurized gas container. By appropriate arrangement and its repeatable intermittent operation (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 rebuild the desired pressure in the pump chamber. After this, the gas container must be replenished 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 the 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 the deflected state. In other preferred embodiments, the steel compression spring has a load of about 2 N to about 200 N, or about 10 N to about 100 N, in its deflected state.

[0052] In one preferred embodiment, a single dose of the drug (i.e., a medically active liquid aerosol) 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 this case, the user or patient primes and activates the device only once and inhales the released aerosol in one breathing operation per administration (i.e., per administration event).

[0053] In another preferred embodiment, a single dose of the drug consists of two aerosol units, thus requiring two pumping cycles. Typically, the user or patient primes the inhaler, activates the inhaler to release and inhale the aerosol units, and then repeats the procedure. 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 this inhalation device system in a single pumping cycle may preferably be in the range of about 0.1 μL to about 1000 μL, or about 1 μL to about 250 μL, or about 2 μL to about 150 μL. In particular, the volume may be in the range of about 2 μL to about 50 μL, or about 5 μL to about 25 μL, more specifically about 10 μL to about 20 μL, for example, about 15 μL. These volume ranges are approximately the same as the volume of the liquid phase contained in one unit of aerosol produced by the inhalation device, with only slight differences, possibly due to minute liquid losses within the device.

[0055] In further specific embodiments, the pump unit of the suction device comprises an inlet valve, also called a check valve or inlet check valve, located within a hollow cylinder. According to this embodiment, the internal space of the hollow cylinder, i.e., the pump chamber, is fluidly connected to a fluid reservoir via the inlet check valve. The inlet valve allows the flow of fluid into the pump chamber but prevents backflow of a medically active fluid into or to a replaceable fluid reservoir. In preferred embodiments, the inlet valve may be located at or near the upstream end of the cylinder so as to make substantially the entire internal volume of the hollow cylinder available to function as the pump chamber. Alternatively, it may be located more centrally along the (longitudinal) principal axis of the hollow cylinder so as to define the upstream and downstream segments of the cylinder, with 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 described above, one of the advantageous effects of certain embodiments of pump units having a fixed or immovable piston is that an inlet valve having relatively large dimensions can be housed in this position, i.e., at the upstream end of the pump chamber. This is particularly beneficial because it allows for a large dimension of fluid conduit within the valve and thus a high fluid velocity that transitions to rapid filling of the pump chamber during priming of the inhalation device. Furthermore, the use of medically active liquids with higher viscosity than ordinary liquid formulations for inhalation, such as highly concentrated solutions of soluble active ingredients, becomes feasible for inhalation therapy.

[0057] In further embodiments, the inlet valve may be adapted to open only when the pressure difference between the upstream and downstream sides of the valve, i.e., the fluid reservoir side and the pump chamber side, exceeds a predetermined threshold, and remains closed as long as the pressure difference is below the threshold. In this context, the term “pressure difference” means that only the relative pressure difference between the two sides, regardless of absolute pressure values, is relevant to determining whether the valve blocks or opens. 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, no device startup), the pressure difference (0.01 bar in this case) is below the threshold value (e.g., 20 mbar), so the valve remains closed even if positive pressure is applied in the direction of opening. This means that the check valve remains closed until the threshold pressure is met, and therefore safely keeps the passage between the reservoir and the pump chamber closed, for example, when the suction device is not in use. Examples of threshold pressure differences include those in the range of 1 to 1000 mbar, more preferably between about 10 to about 500 mbar, or between about 1 to about 20 mbar.

[0058] When the suction device of this suction device system is activated, the means for storing potential energy changes its state from locked to unlocked, releasing energy that causes the cylinder to perform its propulsive longitudinal motion, and a considerable amount of pressure is accumulated in the pump chamber. This creates a significant pressure difference due to the substantially low pressure in the fluid reservoir, which exceeds the high pressure and pressure difference threshold in the pump chamber, resulting in the check valve opening and the pressure chamber being filled with medical fluid from the replaceable reservoir.

[0059] One type of valve that can be designed to operate at such threshold pressure differences is a spring-loaded ball valve. The spring pushes the ball into its seat, and the ball valve opens only when the pressure acting on the spring force exceeds the spring force. Depending on their structure, other types of valves that can operate at such threshold pressure differences are duckbill valves or flap valves.

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

[0061] In further specific embodiments, the suction 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 avoid a return flow of liquid or air from the riser pipe to the hollow cylinder. In many cases, the use of such an outlet valve proves advantageous. Typically, the downstream end of the riser pipe is located near the nozzle. The nozzle is in fluid communication with the outside air. After releasing in an aerosolized form an amount of medically active liquid delivered from the pump unit through the nozzle, driven by the longitudinal propulsive motion of the cylinder, the pump chamber must be refilled. For this purpose, the riser pipe slides back to its previous upstream position (i.e., performing a repulsive longitudinal movement) so as to increase the internal volume of the pump chamber. This generates a relative negative pressure (sometimes called "low pressure") 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 drawn 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 toward 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) the threshold pressure difference, as described in the context of the inlet valve above. If a spring-loaded ball valve is used, the spring force must be directed towards the pump chamber so that the outlet valve opens when the difference between the internal pressure of the pump chamber and the ambient pressure exceeds the threshold pressure difference. The advantages of such a valve correspond to the respective advantages described above.

[0063] As described above, the outlet valve may be located within the riser pipe as described above. Alternatively, the suction device may not be integrated within the riser pipe, but may include an outlet valve located at or near one end of the riser pipe, particularly at or near its downstream end, for example, at 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 would make valve integration difficult. By housing 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 further alternative embodiments, the outlet valve is absent. This embodiment may be feasible because the fluid channel of the impingement nozzle can have a relatively small cross-section, resulting in a small or very slow backflow of the medically active fluid under given pressure conditions during priming of the inhaler. If the amount of backflow is considered acceptable considering the specific product application, the inhaler design can be simplified by avoiding the outlet valve.

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

[0066] The replaceable reservoir for holding the medically active fluid 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 means the housing of the entire cartridge system, including all its components such as the outer wall of the cartridge system. Total volume of the entire cartridge system V o In typical embodiments, the amount may be selected from a 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 liquid. e It comprises a container portion having a connection port adapted to allow the cartridge system to be opened and fluidly connected to the pump unit, particularly via a connection unit of the inhalation device housing unit.

[0068] In a typical embodiment, the container portion of this replaceable cartridge system has an effective volume V selected from approximately 0.1 to approximately 50 mL, or approximately 0.1 mL to approximately 25 mL, or approximately 1 mL to approximately 15 mL, or approximately 1 to approximately 10 mL, more specifically approximately 3 mL to approximately 6 mL, or approximately 6 mL to approximately 9 mL, more specifically approximately 4.0 mL to approximately 5.0 mL, or approximately 7.0 mL to approximately 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 the establishment of a fluid connection to the lumen of the container portion and the medically active liquid contained therein. The term “effective volume” means the containment of the entire container portion, including the outer wall of the container portion or all its components, such as the connection port, such as a cap. The terms “cavity” or “lumen” as used herein in relation to hollow bodies such as container portions, extension elements, etc., mean the internal space or cavity inside such a hollow body, whether or not such an internal space or cavity is completely or partially enclosed by the outer wall of the hollow body.

[0070] In more specific embodiments, the container portion of the replaceable cartridge system may be in the form of a flexible container, or it 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 discharged from the container during the standard operation of the inhalation device system, or in other words, when the medically active liquid is drawn from the container portion by the pump unit during the spraying and administration of the medically active liquid. In specific embodiments of the inhalation device system, the container portion of the replaceable cartridge system is in the form of a dimensionally stable container. In more specific embodiments, the container portion of the replaceable cartridge system is in the form of a dimensionally stable container including a flexible or foldable inner container, as will be described in more detail below, the inner container containing the medically active liquid administered by the inhalation device system of the present invention.

[0071] In general, the container portion 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 inhalation device system, especially if provided in a dimensionally stable form. In particular 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, with respect to the axissymmetry of the container device or cartridge system as a whole, with respect to the main axis of rotation of the container device or cartridge system connecting the center of its upstream end to the center of its downstream end, this may allow advantageous embodiments in which the container device or cartridge system may or may not be inserted into the inhalation device in only a particular 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 direction of rotation around the longitudinal principal axis.

[0072] In further embodiments, the container portion may be in the form of a bottle, preferably having a (main) opening at its downstream end, for filling or discharging the medically active liquid to be stored and administered. However, it should be noted that the container portion may also have additional (smaller) openings, for example, for ventilation purposes.

[0073] In further specific embodiments, the extension element of the replaceable cartridge system may be in the form of a rigid, in other words, 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 when it is drawn out from the container portion by the pump unit during the standard operation of the inhalation device system, or in other words, during the spraying and administration of a medically active liquid. In specific embodiments of the inhalation device system, the extension element of the replaceable cartridge system is in the form of a dimensionally stable hollow body or container.

[0074] In further specific embodiments, both the container portion 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 a hollow body.

[0075] In general, both the container portion and the extension element may 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 inhalation device system, especially if provided in a dimensionally stable form. In particular 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, with respect to the axissymmetry of the entire container device or cartridge system with respect to the main axis of rotation of the container device or cartridge system, with respect to the axissymmetry of the entire container device or cartridge system, with respect to the main axis of rotation of the container device or cartridge system connecting the center of its upstream end to the center of its downstream end, this may allow advantageous embodiments in which the container device or cartridge system may or may not be inserted into the inhalation device in only a particular 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 direction of rotation around the longitudinal principal axis.

[0076] In further embodiments, the container portion may be in the form of a bottle, preferably having a (main) opening at its downstream end, for filling or discharging the medically active liquid to be stored and administered. However, it should be noted that the container portion may also have additional (smaller) openings, for example, for ventilation purposes.

[0077] In further specific embodiments, the extension element and the container portion may be provided independently of each other, particularly in the form of a container or hollow body including at least one elastic portion, especially when provided in a dimensionally stable form as described above. The term “elastic” as used herein means that at least a portion of the container or hollow body of the extension element and / or container portion can be reversibly deformed, particularly by applying an external force to the outer wall of such container or hollow body, thereby allowing the temporarily deformed container or hollow body to relax and return to its original shape after the removal of the external force applied to the extension element or container portion. 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 a 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 will be described in more detail below.

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

[0079] In certain embodiments, the replaceable reservoir container portion holds a medically active liquid and has a maximum internal volume V i It may include an inner container having an internal volume (V) as used herein in relation to the container portion. iThe term ) refers to the total internal volume of a container portion that can be filled (partially or completely) with a liquid, specifically a medically active liquid administered by the inhalation device system according to the present invention. Thus, the internal volume V of the container portion completely filled with the medically active liquid. i This corresponds to the volume of the medically active liquid contained in such a fully filled container portion. In a typical embodiment, the maximum internal volume V i The effective volume V of the container portion. e This corresponds to approximately 0.1 to about 15 mL, or about 1 to about 10 mL, more 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, which may be selected within this range. However, in further embodiments, the maximum internal volume V of the optional inner container may be selected. i The effective volume V of the container portion. e It may be smaller than that, resulting in a situation where the entire lumen of the container portion is not filled with an optional inner container.

[0080] For example, an inner container that can be housed in the reservoir's container portion may be designed to be foldable by means of a flexible or elastic wall. The effect of such a design is that, during repeated use of the device, including progressively emptying the reservoir, the flexible or elastic wall buckles or folds to reduce the internal volume of the reservoir, and as a result, the negative pressure required to extract a certain amount of liquid does not need to increase substantially over the period of use. In particular, an optional inner container of a replaceable reservoir may be designed as a foldable bag. The advantage of a foldable bag is that the pressure inside the reservoir is largely independent of the fill level and the effects of thermal expansion are negligible. Also, the structure of such a reservoir type is fairly simple and already well established. However, in further embodiments, the inner container may have a non-flexible or rigid form in which pressure equilibrium with the ambient atmosphere during the administration of the medical fluid stored inside 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 includes an additional volume V a It further comprises an extension element having the following: In a preferred embodiment, the effective volume V of the container portion e and the additional volume V of the extension element a The sum of these is the total volume V of the cartridge system as described above. o It is equivalent to, and is assembled in a manner that will be described in more detail below. In certain embodiments, the effective volume V e This corresponds to the entire internal volume of the container, and the additional volume V a This corresponds to the entire internal volume of the extension element. In a typical embodiment, the additional volume V of the extension element a The specific total length L of the cartridge system o and the selected effective volume V of the container portion e Taking this into consideration, it may be selected as needed within the range of approximately 0.1 mL to approximately 100 mL. In certain embodiments, the additional volume V of the extension element a The volume may be selected within the range of approximately 0.1 mL to approximately 25 mL, or approximately 0.1 mL to approximately 10 mL, or approximately 0.2 mL to approximately 5.0 mL, or approximately 0.5 mL to approximately 3.5 mL. The extension element may be attached to the outer surface of the container portion, more specifically, as will be described in more detail below.

[0082] In a further embodiment, the replaceable cartridge system has a total length L corresponding to the length of the replaceable cartridge system, measured from the upstream end to the downstream end of the cartridge system when assembled, or in other words, with the container portion attached to the extension element of the cartridge system. o In a further embodiment, the container portion has an effective length L measured from the upstream end to the downstream end of the container 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 It has (additional length). In a typical embodiment, the effective length L of the container portion. eThe additional length L of the container portion may be selected from a range of approximately 0.5 cm to approximately 20 cm, or approximately 1 cm to approximately 15 cm, or approximately 2.5 cm to approximately 10 cm, or approximately 4.0 cm to approximately 8.0 cm. In a more typical embodiment, the additional length L of the container portion may be selected from a range of approximately 0.5 cm to approximately 20 cm, or approximately 1 cm to approximately 15 cm, or approximately 2.5 cm to approximately 10 cm, or approximately 4.0 cm to approximately 8.0 cm. a The length may be selected within the range of approximately 0.5 cm to approximately 19.5 cm, or approximately 1.5 cm to approximately 10 cm, or approximately 2.5 cm to approximately 5.0 cm.

[0083] In certain embodiments, when assembled, i.e., with the extension element attached to or mounted on the outer surface of the container element, the total length L of the resulting replaceable cartridge system is o The effective length L of the container portion. e and the additional length L of the extension element a It is equal to the sum of the above. Furthermore, it should be noted that the relevant 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 necessary to attach the elements to each other, as will be described in more detail below.

[0084] In certain embodiments, the housing unit of the inhalation device may be adapted to receive, or fully receive, a replaceable cartridge system and fluid connection, as described above. In these cases, the housing unit preferably has a specified total length L o and total volume V o Adapted to accommodate a replaceable reservoir having the specified total length L as described above, the replaceable reservoir is fitted to accommodate a replaceable reservoir having the specified total length L o and total volume V o It is provided in the form of a cartridge system having a replaceable reservoir with an effective length L. e A container portion having an additional length L a It comprises an extension element having the effective length L of the container portion. e and the additional length L of the extension element a The sum of these is the total length L of the cartridge system (when assembled). oBeing equal to can be advantageous.

[0085] This reduces the total length of the assembled cartridge system L o However, insofar as it corresponds to the total length of the cartridge system that is introduced into the housing unit of the inhalation device and can be received by the housing unit of the inhalation device, the container portion L e Length and extension element L a This allows for the use of interchangeable cartridge systems, where the length can be varied according to the specific effective volume required. This includes cartridge systems that hold different medically active fluids or different amounts of specific medically active fluids, while maintaining the same overall length L. o It has a specific effective length L e A container portion having a specific additional length L of the extension element a This can be particularly advantageous when the inhalation device can be used with different cartridge systems having different combinations of extension elements. In these cases, the effective volume V depends on the individual amount of medically active liquid stored. e It may be advantageous to provide a cartridge system that enables such compatibility. Furthermore, it may be advantageous to provide an inhalation device system and a corresponding inhalation device that offers the possibility of accepting a cartridge system having an effective volume that can be freely selected depending on the amount of the medically active liquid to be administered.

[0086] As described 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 in such a way that their movement relative to each other is substantially prevented during standard operation. In other words, two fixed or attached parts may be movable only together and immovable or stationary relative to each other under standard operating conditions. If the extension element is attached or fixed to the container part, this means that the resulting cartridge system can be introduced into at least the housing 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 element in such a way that the two components cannot be removed or detached from each other without destroying a permanent physical connection between the two components, and as a result, the connection cannot be restored without further technical means, tools or other aids. For example, the permanent connection may be achieved by bonding, welding, or soldering (in the case of metal parts).

[0088] In alternative, specific embodiments, the extension element of the cartridge system is detachably attached to the outer surface of the container portion, in other words, removable. As used herein, the terms “detachably attached” or “removably attached” mean that the physical connection between the container portion and the extension element can be established and released by the user without the use of further technical means, tools or other aids. In specific 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 or the container portion or both, and as a result, the connection between the extension element and the container portion can be re-established, as will be 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 an adhesive or bonding area, threaded or hook-and-loop fastener element) located on the outer surface of the container portion, in order to form the 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 portion located at the upstream end of the container portion, particularly when the container portion is provided in the form of a bottle having a (main) opening preferably at its downstream end for filling or discharging a medically active liquid to be stored and administered.

[0090] In certain embodiments, extension elements are attached to the outer surface of the container portion by press-fit or shape-fit connections, such as snap-fit ​​connections. In these cases, both the container portion and the extension element include corresponding structures or elements, such as rings or projections or corresponding recesses, that enable the establishment of the shape-fit or snap-fit ​​connection. Depending on the physical force required to establish or reverse such press-fit, shape-fit, or snap-fit ​​connection, such connection may be permanent or reversible, in other words, removable as described above. In the case of a substantially reversible and non-permanent connection between the extension element and the container portion of the cartridge system, it may be advantageous that the force required to detach and remove the extension element from the outer surface of the container portion is greater than the force required to remove the cartridge system from the inhalation device housing unit. This makes it possible to remove the cartridge system from the inhalation device housing unit by pulling the cartridge system out of the inhalation device housing unit, for example, when the cartridge system may be introduced or inserted downstream along the longitudinal principal axis of the inhalation device from the upstream end of the inhalation device.

[0091] However, in alternative embodiments, it may be beneficial that the force required to remove the extension element from the container portion is lower than the force required to remove the cartridge system from the inhalation device's housing unit or connection unit, respectively. This allows for selective removal of the extension element from the housing unit, while the container portion remains within the housing 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, magnetism, hook-and-loop fasteners, screws, threads, or Luer locks. 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 having a flexible portion.

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

[0094] In further specific 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 press-fit, shape-fit or snap-fit ​​connection.

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

[0096] In certain embodiments, the extension unit of the cartridge system may 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, which is particularly beneficial when the two elements are attached or secured to each other by shape fitting, press-fit, or snap-fit ​​connections. 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 into an opening (e.g., the upstream end of the container portion) of the extension element (e.g., the downstream end). 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 in which the container portion is attached or secured to the extension element by introduction into an opening (e.g., the downstream end of the extension element) of the container portion (e.g., the upstream end of the extension element).

[0097] In general, cartridge systems may have symmetrical or asymmetrical cross-sectional shapes. An asymmetrical cross-section may be advantageous if it is important that the cartridge system can be introduced into or housed in the inhalation device housing unit only 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 (with the downstream end perpendicular to the main central axis connecting to the upstream end of the replaceable cartridge system), particularly to facilitate the 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 a circular cross-section. 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 extension elements whose diameter can widen towards the upstream end of the extension element.

[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 the downstream end may have an opening, the opening having an inner diameter corresponding to the outer diameter of the upstream end of the container portion. As outlined above, in particular when the extension element is attached to the container portion by shape fitting or snap-fit ​​connection, it may be beneficial to have additional structures, such as corresponding projections or recesses, on the contact surfaces. In further embodiments where the extension element is attached to the container portion by press-fit connection, it may be beneficial that such additional structures are absent. For example, when the upstream end of the container portion is introduced 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] In certain embodiments, the extension elements may be made from the same materials as those described above for the container elements, or from different materials. However, in either case, the extension elements may be made from polymer materials, specifically thermoplastic polymers such as polyethylene, polypropylene, polyoxymethylene (POM), and polystyrene. In certain embodiments, it may be advantageous to use polyethylene or polypropylene, particularly polypropylene.

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

[0101] In certain embodiments, at least one internal space or cavity may include further elements of a functional or non-functional nature. As used herein, the term “functional element” means any element required for an extension element or cartridge system, or an element that enables the function of an extension element or cartridge system, other than the storage of the medically active liquid dispensed by the inhalation device system.

[0102] In certain embodiments, the extension element may be a hollow body that does not contain any functional elements. However, in alternative embodiments, the extension element of the cartridge system may include one or more functional elements housed within the internal space of the extension element. In exemplary, non-limiting embodiments, such functional elements may be selected from the group consisting of indicator devices, block mechanisms, electronic interfaces such as Bluetooth® interfaces, electronic coding systems, electronic data loggers, coding elements such as RFID tags or chips, pressure reservoirs, command means, visualization elements, electromechanical interfaces, displays, and the like. In particular, if the internal space or cavity of the extension element contains an indicator device, a block element, or an equivalent function, the internal space may include mechanical elements such as gear units, drive elements such as drive shafts, gears, push buttons, and the like. This allows for the effective use of the space or volume corresponding to the internal space or lumen of the extension element, and in many cases, allows for the introduction of further functionality into the inhalation device system without the need to increase the overall size of the handheld inhalation device system, preferably.

[0103] On the other hand, it may be advantageous for the extension element to not include functional elements, particularly if the extension element may be exposed to potentially damaging conditions such as exposure to reactive gases or radiation during sterilization. Therefore, in certain embodiments, the extension element of the cartridge system does not include functional elements, in particular electronic devices or interfaces. In even more 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 at the downstream end of the extension element, and is adapted to be permanently or removablely fixed or attached to a container element that holds 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 ventilation 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, in particular, 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 the container portion is filled with the medically active liquid, especially if 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 the cartridge system is filled with the medically active liquid.

[0105] As outlined above, the cartridge system has an effective volume V of the container portion. e and additional volume V of the extension element a It has an additional volume V of the extension element in an exemplary embodiment. a Effective volume V of the container portion e The ratio ranges from approximately 20:1 to approximately 1:20, specifically from approximately 10:1 to approximately 1:10, or from approximately 5:1 to approximately 1:5, or from approximately 2.5:1 to approximately 1:2.5, or from approximately 2:1 to approximately 1:1. As outlined above, the cartridge system has an effective length L of the container portion. e and the additional length L of the extension element a It has the following characteristics. In an exemplary embodiment, the effective length L of the container portion e and the additional length L of the extension element aThe ratio is in the range of approximately 20:1 to 1:20, specifically approximately 10:1 to 1:10, or approximately 5:1 to 1:5, or approximately 2.5:1 to 1:2.5, or approximately 2:1 to 1:1.

[0106] A further advantage of this inhalation device system is that it includes the container portion and extension elements, and the total length L o and volume V o A cartridge system having the same total length L o and volume V o The system has the ability to be replaced with a corresponding (standard) cartridge that does not include extension elements, i.e., a cartridge containing only the container element. This modular design allows for maximum flexibility with respect to the inhalation device system, more specifically, the suitability of the inhalation device of the system, and the inhalation device may or may not be used with standard replacement cartridges of specified length and volume that do not have removable or non-removable extension elements. Thus, in certain embodiments of the inhalation device system, the cartridge system can be replaced with a cartridge system without extension elements.

[0107] In further embodiments, the replaceable cartridge system may also be attached to the housing of the inhalation device, more specifically, to a portion of the housing. For example, the cartridge system may be attached to 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” means a surface facing the inside of the housing or inhalation device. The extension element of the cartridge system is an optional connection between the replaceable cartridge system and the housing, specifically the lower part of the housing, and the connection may be permanent or removable. Thus, in some embodiments, the extension element of the cartridge system may be removablely attached to the housing of the inhalation device by press-fit or shape-fit connection as described above. In alternative embodiments, the extension element of the cartridge system may be permanently attached to or fixed to the housing, preferably a removable portion of the housing.

[0108] However, in a preferred embodiment, the extension element may be detachably attached to the housing of the inhalation device. 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. In this case as well, this enables a modular design of the inhalation device system that can operate with different cartridge systems and container portions suited to the volume and properties of the medically active liquid stored inside.

[0109] In a more preferred embodiment, where the extension element is detachably attached to both the container unit and the housing, specifically the detachable lower part of the housing, it may be advantageous that the force required to remove the extension element from the container portion and the force required to remove or disconnect the extension element from the housing are greater than the force required to remove the cartridge system from the inhalation device housing. This allows the entire cartridge system to be removed from the housing unit by removing the detachable portion of the housing from the inhalation device in a single operation.

[0110] However, in alternative embodiments, it may be advantageous that the force required to remove or disconnect the extension element from the housing is 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 inhalation device housing unit. This makes it possible to remove the removable portion of the housing from the inhalation device without removing the cartridge system from the inhalation device housing unit. In further alternative embodiments, it may be advantageous that the force required to remove the extension unit from the container portion is smaller than the force required to remove the container portion from the housing unit connection 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 housing unit.

[0111] In a second aspect, the present invention relates to a replaceable cartridge system for holding a medically active liquid for spraying, which is preferably adapted for use in an inhalation device system according to a first aspect of the present invention, wherein the cartridge system has a total volume V o It has an effective volume V for holding a medically active liquid. e The cartridge system comprises a container portion having an additional volume V, and a connection unit adapted to allow the cartridge system to be releasably and fluidly connected to the pump unit of the suction device, wherein the cartridge system has an additional volume Va The cartridge system further comprises an extension element having a, and the extension unit is attached to the outer surface of the container portion. In a preferred embodiment of this second aspect of the present invention, the effective volume V of the container portion e and the additional volume V of the extension element a The sum of these is the total volume V of the cartridge system (in its assembled state). o It is equal to.

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

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

[0114] In a third aspect, the present invention relates to the total volume V o A method for providing a replaceable reservoir for an inhalation device system of the first aspect of the present invention, having a cartridge system form, specifically a replaceable cartridge system form of the second aspect of the present invention, a) A cartridge system having a connection port (preferably in the form of a cap) adapted to be openable and fluidly connected to the pump unit of an inhalation device system, with an effective volume V for holding a medically active fluid. e A step of providing a container portion having, b) Additional volume V a A step of providing an extension element having, preferably, the effective volume V of the container portion e and the additional volume V of the extension element a The sum of these is the total volume V of the cartridge system (when assembled). o The steps provided are equivalent to, and c) A method comprising the step of attaching an extension element to the outer surface of a container portion.

[0115] According to step a) of this embodiment of the present invention, the cartridge system comprises a connection port (preferably in the form of a cap) adapted to be openable and fluidly connected to the pump unit of the inhalation device system, with an effective volume V for holding a medically active liquid. e A container portion having the above is provided.

[0116] In a preferred embodiment of this third aspect of the present invention, the container portion is provided in the form of a dimensionally stable container, more specifically in the form of a stable hollow body or container having a connection port at the downstream end (adapted to allow the cartridge system to be opened and fluidly connected to the pump unit of the suction device system), and having a surface portion at the upstream end opposite the container that is adapted to be opened or permanently, preferably openly connected to an extension element.

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

[0118] In a further embodiment of this aspect of the present invention, the extension element is provided in the form of a dimensionally stable hollow body and preferably has an opening or other fastening means at the downstream end of the extension element. As described in detail above in relation to the suction device system of the first aspect of the present invention, the extension element may have an opening or another surface area having fastening means adapted to connect, for example, releasably or permanently, preferably releasably, to a 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 embodiment of the present 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 by, for example, bringing an opening on the surface of the extension element or other connecting means into contact with a corresponding surface portion or connecting means of the container portion. In certain embodiments, the fastening means of the extension element may be manually pressed against the corresponding fastening means or the outer surface of the container portion. However, in alternative embodiments, the extension element may be screwed into a corresponding thread on the outer surface of the container portion.

[0120] In further specific embodiments, the method of this aspect of the present invention further includes an additional step a1) after step a), followed by step b):

[0121] a1) The step of introducing a container portion into a housing unit of an inhalation device system according to a first aspect of the present invention, and optionally connecting the connection port of the container portion to the pump unit of the inhalation device system.

[0122] In this embodiment, the method further includes an additional step b1) following step b), and a subsequent step c). b1) Further includes the step of introducing the extension element into the housing unit of the suction device.

[0123] Detailed description of the drawing Figure 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) inserted into the inhalation device. The inhalation device (20) has a housing (21) having a lower part (22), the lower part can be separated and removed from the inhalation device (20) to open the housing (21) and allow access to a housing unit (23) into which the replaceable cartridge system (30) can be inserted. The housing unit (23) further has a connection unit (24) adapted to be openable and fluidly connected to a connection port (32) of the replaceable reservoir.

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

[0125] The pump unit (40) has an upstream end (41) fluid-connected to a replaceable reservoir (30) and a downstream end (42) fluid-connected to a nozzle (25), and the pump unit (40) further comprises (i) a riser pipe (43) having an upstream end (44), which is adapted to function as a piston within the pump unit (40) and is firmly fixed 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 as to be longitudinally movable on the riser pipe (44).

[0126] As also shown in Figure 1, the pump unit (40) is a lockable means for (iii) storing potential energy (46) when locked and releasing the stored energy when unlocked, the means (46) being located outside the cylinder (41) and mechanically coupled to the cylinder (45), and when the means (46) is unlocked, the cylinder (45) moves longitudinally toward the downstream end of the pump unit (42).

[0127] Figure 2 shows the inhalation device system (10) with the same inhalation device (20), but viewed from a different angle, and the reference signs of the elements described with reference to Figure 1 are partially omitted. As can be seen herein, the housing (21) of the inhalation device, when in the closed state, comprises a cap (26) arranged at the downstream end (27), in other words on the side of the housing facing the user, covering said downstream end. The housing (21) further comprises a removable lower portion (22) located at the upstream end on the opposite side of the inhalation device. The removable lower portion (22) of the housing, when removed from the inhalation device, allows access to a receiving unit (23) into or from 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 the pump unit (40). The cartridge system (30) of the inhalation device system (10) further comprises an extension element (33) attached to the outer surface of the container portion (31), more specifically to the upstream end (34) of the container portion. As can be seen from Figure 2, the effective length L of the container portion (31) e and the additional length L of the extension element (33) a sum to the total length L of the cartridge system (30) in the assembled state as shown in the figure o , which in this case corresponds to the total 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 , the effective volume V of the container portion (31) e and the additional volume V of the extension element (33) a sum to the total volume V of the cartridge system (30) in the assembled state oIt is equal to. Furthermore, Figure 2 (as in Figure 1) shows the inlet check valve (47) located at the upstream end of the hollow cylinder.

[0129] Figure 3 shows side views of the replaceable cartridge system (30) in a disassembled state or before assembly. The cartridge system (30) has a container portion (31) having a connection port or unit (32) in the form of a cap, which is located at the downstream end (35) of the container portion (31) and attached. The container portion has a substantially cylindrical shape. In the illustrated example, the diameter narrows at the upstream end (34) of the container portion and has a projection (36) for establishing a connection to an extension element (33) by shape fitting or snap fitting.

[0130] Figure 4 shows a perspective view of the cartridge system (30) of Figure 3, which has 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) before assembly or after disassembly. As can be seen from the figure, 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) to establish a shape or snap-fit ​​connection to the corresponding projection (36) of the container portion (31). However, it should be noted that in the reverse configuration, the container portion can be provided in the recess and the extension element can be provided in the corresponding projection. In either case, the connection can be established, for example, by 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) by hand. It should be noted that, depending on the specific shape and structure of the projection (36) and recess (38), a shape or snap-fit ​​connection can be established that is permanent or can be reversed by, for example, manually removing or pulling away the extension element (33) from the container portion (31). As also seen in Figure 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 the assembly of the cartridge system (30). Furthermore, Figure 4 shows a longitudinal principal axis (A) connecting the center of the downstream end of the cartridge system in the form of a cap (32) to the center of the upstream end of the cartridge system, and more specifically, to the center of the upstream end of the extension element (33).

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

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

[0133] Figure 7 shows the cartridge system (30) of Figure 6 in an assembled state. Description of Reference Numerals

[0134] 10 Inhaler system 20 Inhaler 21 Housing 22 Lower part of housing 23 Receiving unit 24 Connection unit 25 Nozzle 26 caps 30 replaceable cartridge system 31 Container part 32 connection ports 33 Extension elements 34 Upstream end of the container section 35 Downstream end of the container section 36 Protrusion 37 Opening of extension element 38. Indentation 39 Ventilation openings 39a Window 39b Inner space, lumen of extension element 40 Pump Units 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. The central axis of the cartridge system L e Effective length of the container portion L a Additional length of extension element L o Total length of the cartridge system V e Effective volume of the container V a Additional volume of extension element V o Total volume of the cartridge system

[0135] The following is a list of numbered embodiments E1 to E30 included in the present invention.

[0136] E1 An inhalation device system (10) for inhaling a medically active liquid in spray form, comprising an inhalation device (20) and a replaceable reservoir (30) for holding the medically active liquid, The inhalation device (20) is A housing (21) having a housing unit (23), the housing unit having a connection unit (24) adapted to be openable and fluidly connected to a connection port (31) of a replaceable reservoir (30), the housing (24) receiving the replaceable reservoir (30) and adapted to be fluidly connected to the replaceable reservoir (30), A nozzle (25) for spraying a medically active liquid, and The system comprises a pump unit (40) located within a housing (21), adapted to be fluidly connected to a reservoir (30) and a nozzle (25), and adapted to transport a medically active fluid downstream from the reservoir (30) to the nozzle (25), The replaceable reservoir (30) has a total volume V o It has an effective volume V for holding a medically active liquid. e The cartridge system is provided in the form of a container portion (31) having a container portion (31) and a connection port (32) adapted to allow the cartridge system (30) to be opened and fluidly connected to a pump unit (40), wherein the cartridge system (30) has an additional volume V a An inhalation device system (10) further comprising an extension element (33) having a container portion (31), the extension element (33) being attached to the outer surface of the container portion (31).

[0137] E2 Effective volume V of 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 An inhalation device system (10) according to Embodiment E1, which is equivalent to the above.

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

[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, specifically in the form of a foldable bag.

[0140] E5 The container portion (31) is provided in a dimensionally stable form, and is an inhalation device system (10) according to any one of embodiments E1 to E4.

[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 form.

[0143] E8 The container portion (31) is an inhalation device system (10) according to any one of embodiments E1 to E7, comprising at least one elastic portion.

[0144] E9 An inhalation device system (10) according to any one embodiment 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) include at least one elastic portion.

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

[0147] E11 The storage unit (23) has a specified total length L o and total volume V o Adapted to receive and fluidize a replaceable reservoir (30) having a specified total 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 the following:

[0148] E12 A replaceable reservoir (30) with an effective length L e A container portion (31) having an additional length L a The container portion (31) has an extension element (33) and an effective length L 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 its assembled state). o An inhalation device system according to any one of embodiments E1 to E11, which is equivalent to the one described above.

[0149] E13 An inhalation device system (10) according to any one of embodiments E1 to E12, wherein an extension element (33) of the cartridge system (30) is detachably 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 only to 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 greater than the force required to remove the cartridge system (30) from the housing unit (23) of the inhalation device (20).

[0153] E17 An inhalation device system (10) according to any one of embodiments E1 to E12, wherein an 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) according to any one of embodiments E1 to 17, wherein the replaceable cartridge system (30) (when assembled) has a cylindrical shape with a central longitudinal axis (A) that connects the connection port (32) of the container portion (31) located at the downstream end of the cartridge system (30) to 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), a connection port (32) is located at the downstream end (34) of the container portion (31), and an extension element (33) is attached to the upstream end (35) of the container portion.

[0156] E20 An inhalation device system (10) according to any one of embodiments E1 to E19, wherein an extension element (33) is attached to the outer surface of a container portion (31) by press-fitting or shape-fitting 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 The cartridge system (30) has an extension element (33) and a container portion (31) having a circular cross-section, as described in any one of embodiments E1 to E21, inhalation device system (10).

[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, and the opening has a diameter corresponding to the (outer) diameter of the upstream end (34) of the container portion.

[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 that does not contain any functional elements.

[0161] E25 An inhalation device system (10) according to any one of embodiments E1 to E24, wherein the extension element (33) does not contain a 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 Inhalation device system (10) according to any one of embodiments E1 to E26, wherein the container portion (31) and extension element (33) are assembled and sterilized before filling the cartridge system (30) with a medically active liquid.

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

[0165] E29 A suction device system (10) according to embodiments E1 to E28, wherein the functional elements are selected from an indicator device, a block mechanism, an electronic interface, an electronic coding system, an electronic data logger, a coding element, a pressure reservoir, and an indicator 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 include an indicator device for counting the number of uses of the inhalation device or replaceable reservoir.

[0167] E31 The replaceable cartridge (30) is selected within the range of approximately 0.2 mL to approximately 30 mL, for a total volume V. o An inhalation device system (10) according to any one of embodiments E1 to E30, having the above characteristics.

[0168] E32 The container portion (31) of the replaceable cartridge system (30) has an effective volume V selected within the range of approximately 1 mL to approximately 15 mL, or approximately 1 to approximately 10 mL, specifically approximately 3 mL to approximately 6 mL, or approximately 6 mL to approximately 9 mL, more specifically approximately 4.0 mL to approximately 5.0 mL, or approximately 7.0 mL to approximately 8.0 mL. e An inhalation device system (10) according to any one of embodiments E1 to E31, having the above characteristics.

[0169] E33 Additional volume V of extension element (33) a However, the inhalation device system (10) according to any one of Embodiments E1 to E32 may be selected from within the range of approximately 0.1 ml to approximately 25 ml, or approximately 0.2 ml to approximately 5.0 ml, or approximately 0.5 ml to approximately 3.5 ml.

[0170] E34 The cartridge system (30) is replaceable with a cartridge system without extension elements, as described in any one of embodiments E1 to E33, in the inhalation device system (10).

[0171] E35 The pump unit (40) of the suction device (20) The upstream end is fluid-connected to a replaceable reservoir (30), The nozzle (25) has a downstream end that is fluid-connected to it. The pump unit is (i) A riser pipe (43) having an upstream end, Adapted to function as a piston within a pump unit, A riser pipe (43) is securely fixed to the side of the housing (21) facing the user, so as to be immovable relative to the housing (21), and (ii) The suction device (10) according to embodiments E1 to E34, further comprising 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).

[0172] E36 The pump unit (40) is (iii) A suction device system (10) according to Embodiment 35, comprising a lockable means for storing potential energy (46) when locked and releasing the stored energy when unlocked, the means (46) being located outside the cylinder (41) and mechanically coupled to the cylinder (41), such that when the means (46) is unlocked, the cylinder (41) moves longitudinally toward the downstream end of the pump unit.

[0173] E37 A medically active liquid for spraying is held in an inhalation device system (10) according to any of embodiments E1 to E36. Use Suitable for doingA replaceable cartridge system (30), comprising a container portion (31) having a total volume Vo and an effective volume Ve for holding a medically active liquid, and a connecting unit (24) adapted to allow the cartridge system (30) to be released and fluidly connected to a pump unit (40) of an inhalation device (20), wherein the cartridge system (30) further comprises an extension element (33) having an additional volume Va, the extension element (33) being attached to the outer surface of the container portion (31).

[0174] E38 Effective volume V of 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) (in its assembled state). o A replaceable cartridge system equivalent to the one described in Embodiment E37.

[0175] E39 The form of the cartridge system, specifically the total 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 having, a) A cartridge system having a connection port (preferably in the form of a cap) adapted to be openable and fluidly connected to the pump unit of an inhalation device system, with an effective volume V for holding a medically active fluid. e A step of providing a container portion having, b) Additional volume V a A step of providing an extension element having, preferably, the effective volume V of the container portion e and the additional volume V of the extension element a The sum of these is the total volume V of the cartridge system (when assembled). o The steps provided are equivalent to, and c) A method comprising the step of attaching an extension element to the outer surface of a container portion.

[0176] E40 The method according to Embodiment 39, a1) A method further comprising the step of introducing a container portion into a housing unit of an inhalation device system according to a first aspect of the present invention, and optionally connecting the connection port of the container portion to a pump unit of the inhalation device system.

[0177] E41 The method according to Embodiment 40, b1) A method further comprising the step of introducing an extension element into a housing unit of an inhalation device.

Claims

1. An inhalation device system (10) for administering a medically active liquid in spray form by inhalation, comprising an inhalation device (20) and a replaceable cartridge system (30) for holding the medically active liquid, The aforementioned suction device (20) A housing (21) having a housing unit (23), wherein the housing unit has a connection unit (24) adapted to be openable and fluidly connected to a connection port (32) of the replaceable cartridge system (30), and the housing unit (23) is adapted to house the replaceable cartridge system (30) and to be fluidly connected to the replaceable cartridge system (30), A nozzle (25) for spraying the aforementioned medically active liquid, and The housing (21) comprises a pump unit (40) which is arranged within the housing (21), is adapted to be fluidly connected to the cartridge system (30) and the nozzle (25), and is adapted to transport the medically active liquid downstream from the cartridge system (30) to the nozzle (25), The replaceable cartridge system (30) has a total volume (V ｏ ) has an effective volume (V) for holding the medically active liquid. ｅ The cartridge system (30) comprises a container portion (31) having an additional volume (V) and a connection port (32) adapted to allow the cartridge system (30) to be discharged and fluidly connected to the pump unit (40), wherein the cartridge system (30) has an additional volume (V) ａ An inhalation device system (10) further comprising an extension element (33) having ), wherein the extension element (33) is removably attached to the outer surface of the container portion (31), and 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 housing unit (23) of the inhalation device (20).

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 the above is the total volume V of the cartridge system (30). ｏ An inhalation device system (10) according to claim 1, which is equivalent to the one described in claim 1.

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

4. The inhalation device system (10) according to any one of claims 1 to 3, wherein the inner container of the container portion (31) is provided in the form of a bag.

5. Said accommodation unit (23) is adapted to receive and make fluid connection with an exchangeable cartridge system (30) having a specified total length L ｏ and a total volume V ｏ , said exchangeable cartridge system (30) is provided in the form of a cartridge system having a specified total length L ｏ and a total volume V ｏ , wherein the inhalation device system (10) according to any one of claims 1 to 4.

6. The replaceable cartridge system (30) has an effective length L ｅ A container portion (31) having an additional length L ａ The container portion (31) comprises an extension element (33) having the effective length L ｅ and the additional length L of the extension element (33) ａ The sum of the above is the total length L of the cartridge system (30). ｏ An inhalation device system according to any one of claims 1 to 5, which is equivalent to the one described above.

7. The container portion (31) is provided in a dimensionally stable form, as described in the suction device system (10) according to any one of claims 1 to 6.

8. The suction device system (10) according to any one of claims 1 to 7, wherein the extension element (33) is provided in a dimensionally stable form.

9. The suction device system (10) according to any one of claims 1 to 8, wherein the extension element (33) comprises at least one elastic portion.

10. The inhalation device system (10) according to any one of claims 1 to 9, 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.

11. The inhalation device system (10) according to any one of claims 1 to 10, wherein the replaceable cartridge system (30) has a cylindrical shape having a central longitudinal axis (A) that connects the connection port (32) of the container portion (31) located at the downstream end of the cartridge system (30) to the bottom of the cartridge system (30) located at the opposite upstream end of the cartridge system (30).

12. The inhalation device system (10) according to any one of claims 1 to 11, 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.

13. The suction device system (10) according to any one of claims 1 to 12, wherein the extension element (33) is attached to the outer surface of the container portion (31) by press-fitting or shape-fitting connection.

14. The inhalation device system (10) according to any one of claims 1 to 13, wherein the extension element (33) has substantially the same cross-sectional diameter as the container portion (31) of the cartridge system (30).

15. The inhalation device system (10) according to any one of claims 1 to 14, wherein the extension element (33) and the container portion (31) of the cartridge system (30) have a circular cross-section.

16. The inhalation device system (10) according to any one of claims 1 to 15, wherein the extension element (33) has an opening (37) at its downstream end, and the opening has a diameter corresponding to the (outer) diameter of the upstream end (34) of the container portion.

17. The suction device system (10) according to any one of claims 1 to 16, wherein the extension element (33) of the cartridge system (30) is a hollow body.

18. The inhalation device system (10) according to any one of claims 1 to 17, wherein the extension element (33) does not contain the medically active liquid to be administered.

19. The inhalation device system (10) according to any one of claims 1 to 18, 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).

20. The suction device system according to any one of claims 1 to 16 and 18 to 19, wherein the extension element (33) includes a functional element selected from an indicator device, a block mechanism, an electronic interface, an electronic coding system, an electronic data logger, a coding element, a pressure reservoir, and an indicating means.

21. The inhalation device system (10) according to any one of claims 1 to 20, wherein the extension element (33) of the cartridge system (30) is not equipped with an indicator device for counting the number of uses of the inhalation device or the replaceable cartridge system.

22. The replaceable cartridge system (30) has a total volume V selected within the range of approximately 0.2 mL to approximately 30 mL. ｏ An inhalation device system (10) according to any one of claims 1 to 21, comprising:

23. The container portion (31) of the replaceable cartridge system (30) has an effective volume V selected within the range of approximately 0.1 to approximately 15 mL. ｅ An inhalation device system (10) according to any one of claims 1 to 22, comprising:

24. The additional volume V of the extension element (33) ａ The inhalation device system (10) according to any one of claims 1 to 23, wherein the amount may be selected within the range of approximately 0.1 ml to approximately 25 ml.

25. The inhalation device system (10) according to any one of claims 1 to 24, wherein the cartridge system (30) can be replaced with a cartridge system without extension elements.

26. The pump unit (40) of the suction device (20) The upstream end of the replaceable cartridge system (30) is fluid-connected to the above-mentioned replaceable cartridge system (30), The nozzle (25) has a downstream end that is fluid-connected to it, The aforementioned pump unit is (i) A riser pipe (43) having an upstream end, Adapted to function as a piston within the aforementioned pump unit, A riser pipe (43) is firmly fixed to the user-facing side of the housing (21) so as to be immovable relative to the housing (21), and (ii) The suction device system (10) according to any one of claims 1 to 25, 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) such that the cylinder (41) is longitudinally movable on the riser pipe (43).

27. The pump unit (40) is (iii) A lockable means for storing potential energy (46) when locked and releasing the stored energy when unlocked, the means (46) being located outside the cylinder (41) and mechanically coupled to the cylinder (41), wherein when the means (46) is unlocked, the cylinder (41) moves longitudinally toward the downstream end of the pump unit, the suction device system (10) according to claim 26.

28. A replaceable cartridge system (30) for holding a medically active liquid for spraying, adapted for use in an inhalation device system (10) according to any one of claims 1 to 27, wherein the cartridge system (30) has a total volume V ｏ It has an effective volume V for holding the medically active liquid. ｅ The system comprises a container portion (31) having a cartridge system (30) and a connecting unit (24) adapted to allow the cartridge system (30) to be releasably and fluidly connected to the pump unit (40) of the suction device (20), wherein the cartridge system (30) has an additional volume V ａ A cartridge system (30) further comprising an extension element (33) having, the extension element (33) being removably attached to the outer surface of the container portion (31), 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 housing unit (23) of the inhalation device (20).

29. 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 A replaceable cartridge system according to claim 28, which is equivalent to the one described in claim 28.

30. The form of the cartridge system, specifically the total volume V ｏ A method for providing a replaceable cartridge system for an inhalation device system according to any one of claims 1 to 27, having a form of the replaceable cartridge system according to claim 28 or 29, a) A cartridge system with a connection port adapted to allow for retractable and fluid connection to the pump unit of the inhalation device system, with an effective volume V for holding a medically active fluid. ｅ A step of providing a container portion having, b) Additional volume V ａ A step of providing an extension element having the effective volume V of the container portion ｅ and the additional volume V of the extension element ａ The sum of these is the total volume V of the cartridge system. ｏ The steps provided are equivalent to, and c) A method comprising the step of attaching an extension element to the outer surface of a container portion.

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