Cartridge for inhalation device

Abstract

The present invention provides a cartridge (1) for an inhalation device for generating and administering a medically active liquid (2) in an aerosolized form, the cartridge is -Dimensionally stable outer casing (10), - A collapsible inner tube (20) located inside the outer casing when the cartridge is assembled, for holding the medically active fluid. Equipped with The foldable inner tube comprises an outlet end (21) having an outlet opening (22), and a closed end (23) opposite the outlet end, the outlet opening and the closed end (centers) define the main axis (X) of the inner tube connecting the outlet opening and the closed end of the tube, The closed end of the tube is closed by a welded joint (24) oriented laterally with respect to the main axis of the inner tube (preferably substantially perpendicular to it). The outer casing includes a deformation element that contacts the welded seam (with the cartridge assembled) such that the welded seam deforms into a radially curved shape due to contact between the welded seam and the deformation element (11).

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 a cartridge for an inhalation device for generating and administering a medically active liquid (2) in aerosolized form, the cartridge comprising a dimensionally stable outer casing and a collapsible inner tube. Furthermore, the present invention also relates to an inhalation device comprising such a cartridge, as well as a method for assembling such a cartridge.

Background Art

[0002] Nebulizers, or other aerosol generators for liquids, were known from the art. In particular, such devices are used in medicine and therapy. In that regard, such devices serve as inhalation devices for applying an active ingredient in the form of an aerosol, i.e., in the form of small droplets embedded in a gas. Such an inhalation device is known, for example, from European Patent No. 0627230 (B1). Indispensable components of such an inhalation device are a reservoir, often in the form of a cartridge, containing the liquid to be aerosolized, a pump device for generating a pressure high enough to atomize the liquid, and further an atomization device in the form of a nozzle. Using the pump device, discrete amounts, i.e., not continuously, of the liquid are withdrawn from the reservoir and supplied to the nozzle. The pump device operates without an aerosol agent and generates pressure mechanically.

[0003] A cartridge for holding medically active liquids is described, for example, in U.S. Patent Publication 2004 / 0143235(A1). This document discloses a container for medical liquids that is airtight and liquid-tight so that it can be stored for months. The container includes a collapsible foil bag with a flange that is stable in shape. The flange is designed to fit onto a discharge connector. The container can be housed in a casing that is stable in shape. The medical liquid is kept out of contact with air and protected from the effects of light. The medical liquid is dispensed from the foil bag in large portions over a long period of time, and each portion of the medical liquid is converted into an aerosol using an atomizer.

[0004] International Publication No. 2009 / 115200(A1) discloses a reservoir for a nebulizer, a nebulizer, and a method for filling the reservoir. To avoid undesirable pressure rises, the liquid chamber of the reservoir is pre-folded and filled with an initial amount of liquid less than the maximum volume of the liquid chamber. The liquid chamber may be pre-folded using an apparatus, which may have at least an operating element or a contact element. As a result of placing the contact element externally in contact with the wall of the fluid chamber, or as a result of deforming the fluid chamber, the actual volume of the fluid chamber available during filling is reduced, i.e., less than the maximum volume of the fluid chamber. As a result, pre-folding is desirable.

[0005] However, a technical problem associated with extracting medically active fluid from such a fluid bag or chamber, especially when drawing multiple small discrete amounts, is the formation of undesirable underpressures inside the fluid bag or chamber, which can potentially affect not only the accurate dispensing of the medically active fluid but also the extraction of the total amount of medically active fluid that the fluid bag or chamber is intended to provide. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] European Patent No. 0627230(B1) [Patent Document 2] U.S. Patent Publication No. 2004 / 0143235(A1) [Patent Document 3] International Publication No. 2009 / 115200(A1) Pamphlet [Patent Document 4] International Publication No. 2011 / 198151(A1) Pamphlet [Patent Document 5] International Publication No. 2023 / 001750(A1) brochure [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] Therefore, an object of the present invention is to provide cartridges for inhalation devices that enable the storage of a wide variety of medically active liquids, including aqueous or organic liquids, in multiple discrete stages, and for drawing out or dispensing these liquids. Another object of the present invention is to provide cartridges for inhalation devices that enable the drawing out or dispensing of medically active liquids in a number of precise, continuous aliquots or doses. Other objects of the present invention will become apparent based on the following description, examples, and claims relating to the present invention. [Means for solving the problem]

[0008] In a first aspect, the present invention relates to a cartridge (1) for an inhalation device for generating and administering a medically active liquid (2) in an aerosolized form, wherein the cartridge is -Dimensionally stable outer casing (10), -At least one deformation element (11), - A collapsible inner tube (20) for holding a medically active fluid, An outlet end (21) having an outlet opening (22), and The closed end (23) opposite to the outlet end defines the main axis (X) of the inner tube connecting the outlet opening and the closed end (center), The closed end of the tube is closed by a welded joint (24) oriented laterally with respect to the main axis of the inner tube (preferably substantially perpendicular to it). closed end It has a foldable inner tube and Equipped with, In the assembled cartridge, the foldable inner tube is located inside the outer casing of the cartridge. In the assembled state, the deformation element (11) contacts the welded joint such that the welded joint deforms and deviates from the transverse line with respect to the main axis of the inner tube due to contact between the welded joint and the deformation element. This relates to a cartridge characterized by the following features.

[0009] In a second aspect, the present invention relates to an inhalation device adapted to utilize a cartridge according to the first aspect of the present invention.

[0010] In a third aspect, the present invention relates to an inhalation device (100) adapted to include a cartridge according to the present invention, and an inhalation system comprising a cartridge according to the present invention.

[0011] In a fourth aspect, the present invention is a method for assembling a cartridge according to the present invention, a) Providing an inner tube and a dimensionally stable outer casing comprising at least one deformation element, b) A step of introducing an inner tube into an outer casing, thereby bringing the welded joint of the inner tube into contact with at least one deformation element and deforming the welded joint of the inner tube, c) The step of filling the inner tube with a medically active liquid, d) Optionally, a step of sealing the cartridge after filling. Regarding methods for providing such a system. [Brief explanation of the drawing]

[0012] [Figure 1] Draw a schematic view of a cartridge for an inhalation device. [Figure 2A] Draw a cross-section of a cartridge for an inhalation device according to the present invention. The assembled cartridge is shown. [Figure 2B] Draw a cross-section of a cartridge for an inhalation device according to the present invention. Cross-sections of some parts of the cartridge are shown. [Figure 2C] Draw a cross-section of a cartridge for an inhalation device according to the present invention. Cross-sections of some parts of the cartridge are shown. [Figure 3A] Illustrate the deformation of the welded seam of the inner tube. [Figure 3B] Illustrate the deformation of the welded seam of the inner tube. [Figure 3C] Illustrate the deformation of the welded seam of the inner tube. [Figure 4] Show an exemplary inhaler with a cartridge.

Embodiments for Carrying out the Invention

[0013] The inventors have found that a new cartridge design, particularly suitable for cartridges with an inner tube made of a stable and / or rigid material, such as thicker plastic or metal, can overcome the disadvantages of the prior art. The inventors have found that dosing and removing fluid from an inner tube containing the fluid can be improved when the inner tube has a welded seam and the welded seam is deformed and deviates from an ideal straight line.

[0014] Accordingly, in a first embodiment, the present invention is a cartridge (1) for an inhalation device for generating and administering a medicinally active liquid (2) in aerosolized form, the cartridge comprising - a dimensionally stable outer casing (10), and - at least one deformation element (11), and - A collapsible inner tube (20) for holding a medically active fluid, An outlet end (21) having an outlet opening (22), and The closed end (23) opposite to the outlet end defines the main axis (X) of the inner tube connecting the outlet opening and the closed end (center), The closed end of the tube is closed by a welded joint (24) oriented laterally with respect to the main axis of the inner tube (preferably, practically perpendicular to it). closed end It has a foldable inner tube and Equipped with, When the cartridge is assembled, the foldable inner tube is located inside the outer casing. In cartridges, In the assembled state, the deformation element (11) contacts the welded joint such that the welded joint deforms and deviates from the ideal transverse line with respect to the main axis of the inner tube due to contact between the welded joint and the deformation element. This relates to a cartridge characterized by the following features.

[0015] In relation to the present invention, the term “welded seam” refers to a welded seam located on the opposite side of the outlet end of the inner tube. The inner foldable tube may have additional welded seams, but in a preferred embodiment, the inner foldable tube has a single welded seam that closes one end of the tube.

[0016] In some embodiments, the welded seam extends laterally with respect to the main axis (X) of the bag. Preferably, the welded seam is rectangular in shape, however, it may be of other shapes, such as U-shape. In preferred embodiments, the welded seam is rectangular in shape.

[0017] The welded seam preferably has a weld height sufficient to effectively close the bag and allows deformation of the seam without substantially creating prepressure on the unwelded portion of the inner foldable tube.

[0018] The welded joint preferably has a height of at least 0.1 mm and up to 0.5 mm. In some embodiments, the height is between 0.1 mm and 5 mm, preferably between 0.1 mm and 2 mm, and more preferably between 0.3 mm and 6 mm. In preferred embodiments, the joint is as small as possible, preferably 3 mm or less, and more preferably between 0.5 mm and 2 mm in height. In some embodiments, the joint has a height selected from 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, and 2 mm.

[0019] The collapsible inner tube is made from any suitable material. More specifically, suitable materials include materials that enable the production of a collapsible tube, which would otherwise still be a rigid type of tube. Preferred materials exhibit a stable form and do not substantially deform when the tube is folded due to the removal of the fluid. Preferably, the collapsible inner tube maintains its overall general shape and substantially shrinks when the fluid is removed.

[0020] The material used for the foldable inner tube also depends on the fluid being used. In some embodiments of the present invention, the cartridge is for an ethanol-based fluid. Accordingly, in some embodiments, the foldable inner bag is made from or comprises a material that does not permeate ethanol. In preferred embodiments, the foldable inner tube is ethanol-impermeable.

[0021] Stable materials include polyethylene, specifically high-density polyethylene, nylon, ethylene vinyl alcohol (EVOH), polyamide, and metals such as polypropylene, aluminum, or mixtures of different materials.

[0022] In some specific embodiments, the collapsible inner tube is made from multiple materials. In some embodiments, the tube is made from layers of different materials, or comprises layers of different materials. When the tube is made from different materials, it may be adapted according to the requirements of the fluid. One layer of material may provide sufficient stability for the inner tube, and a second layer of material may provide fluid impermeability.

[0023] In certain embodiments, the present invention relates to a cartridge as defined above, wherein the inner foldable tube comprises at least two distinct material layers. In some embodiments, the inner foldable tube comprises three or more layers.

[0024] In certain embodiments of the present invention, the foldable inner bag comprises at least three layers: an outer layer comprising a polymer and / or copolymer, a core layer comprising a metal layer, and an inner layer comprising a polymer and / or copolymer. In relation to the present invention, the term outer layer refers to a layer facing the outside of the foldable tube, and the inner layer refers to a layer facing the inside of the foldable tube. The term core layer refers to a layer positioned between the inner and outer layers.

[0025] The foldable inner tube may be any suitable general shape. In some embodiments, the foldable tube is effectively tubular in shape. More specifically, the foldable tube comprises a pouch portion and a collar portion, apart from a welded seam. In these embodiments, the pouch portion is generally closed at one end by a welded seam and connected into the collar portion. The collar portion preferably includes an outlet opening. In some embodiments, the collar portion is further adapted to be attached to or connected to the outer shell of the casing.

[0026] Accordingly, in some embodiments, the present invention relates to a cartridge as defined above, wherein the foldable tube comprises a pouch portion (26) and a collar portion (27), the collar portion having an outlet opening and being adapted to be attached to the shell of the outer casing of the cartridge.

[0027] In some embodiments, the present invention relates to a cartridge as defined above, wherein the pouch portion of the collapsible tube comprises polyethylene, more specifically high-density polyethylene, nylon, ethylene vinyl alcohol (EVOH), polyamide, and a metal such as polypropylene, or aluminum or a mixture thereof. In some embodiments, the pouch portion comprises a number of material layers, each layer independently comprising polyethylene, more specifically high-density polyethylene, nylon, ethylene vinyl alcohol (EVOH), polyamide, and a metal such as polypropylene, or aluminum or a mixture thereof.

[0028] In some embodiments, the present invention relates to a cartridge as defined above, wherein the collapsible tube color portion comprises polyethylene, high-density polyethylene, polylactic acid, and / or polyoxymethylene. The selected material should be compatible with the material of the pouch portion.

[0029] The material selection also allows for the selection of the wall thickness of the foldable inner bag, more specifically, the pouch portion (26) of the foldable inner bag. The thickness may be adjusted according to the requirements of the fluid and the type of inhaler. Preferably, the wall of the foldable inner tube has a thickness of 1 mm or less, excluding the welded seams. In some embodiments, the wall of the inner tube has a thickness between 100 μm and 250 μm. In some embodiments, the thickness is between 125 μm and 225 μm. In preferred embodiments, the thickness is between approximately 150 μm and 200 μm. In specific embodiments, the thickness is approximately 175 μm.

[0030] The inventors have found that when a welded joint deforms within the cartridge, the extraction of fluid from the inner tube containing the welded joint is improved and more controllable. In relation to the present invention, the term "deformed and deviating from the ideal transverse line" means that the welded joint deviates from an angle of 180° rather than following a straight line corresponding to 180°. The deviation may be that the welded joint curves, forms an angle, bends, warps, or otherwise deforms, preferably radially.

[0031] Deviation can be defined by the deviation from the ideal transverse line with respect to the main axis of the foldable inner tube. The furthest point of the weld seam may ideally deviate by at least 1 mm, preferably 1.5 mm, and more preferably 2 mm from the ideal straight transverse line. In some embodiments, the weld seam may deviate by up to 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, or 5 mm from the ideal straight line at its furthest point.

[0032] The aforementioned deviation is caused by a deformation element. In relation to the present invention, the term “deformation element” refers to any element of the cartridge that interacts with or comes into contact with the welded seam of the foldable inner tube and causes deformation of the welded seam.

[0033] The deformation of the welded joint does not necessarily contribute to the pre-folding of the foldable inner tube. The present invention is particularly suitable for foldable inner tubes made from more rigid materials. The deformation of the welded joint allows for controllable folding of the tube. In contrast to the reservoir described in International Publication No. 2009 / 115200(A1), the problem to be solved is not an undesirable increase in pressure inside the inner foldable tube, but rather to avoid underpressure such that the tube does not need to fold completely when fluid is extracted. This problem can be avoided by deformation of the welded joint.

[0034] The deformation element is preferably part of a dimensionally stable outer casing. The outer casing may be a single part or comprise multiple parts. In some embodiments, the dimensionally stable outer casing is integrally molded, comprising a foldable inner tube and an opening that allows for the insertion of the deformation element. In some embodiments, part of the dimensionally stable outer casing comprises multiple components. For example, the dimensionally stable outer casing may comprise multiple parts, such as the casing as defined above and a cap for preventing movement of the foldable inner tube.

[0035] In a preferred embodiment, the present invention relates to a cartridge as defined above, wherein the outer casing is: - A shell (12) having an exit opening and a base opening on the opposite side, - A cap (13) fitted to attach to the exit opening of the shell, - A base (14) fitted to attach to the base opening of the shell and It comprises, or consists of, these.

[0036] The outer casing may include additional components, such as a cartridge extension as described in International Publication No. 2011 / 198151(A1). The cartridge extension may interact with other parts of the inhaler, for example, in the form of a combined counting and blocking device as described in International Publication No. 2023 / 001750(A1).

[0037] The deformation element is positioned within the dimensionally stable outer casing in a manner that allows for deformation of the welded joint as defined above. In most embodiments, the deformation element is located on the opposite side of the casing opening. In embodiments where the dimensionally stable outer casing has a base, it is preferable to provide the deformation element on the base of the outer casing.

[0038] Accordingly, in a preferred embodiment, the present invention relates to a cartridge, wherein the outer casing is - A shell (12) having an exit opening and a base opening on the opposite side, - A cap (13) fitted to attach to the exit opening of the shell, - A base (14) fitted to attach to the base opening of the shell and Equipped with, The deformation element is provided on the base of the outer casing.

[0039] The outer casing and its parts may be made from any suitable material. In some embodiments, the outer casing and its parts are made from the same material as the collapsible inner tube, or partially from the same material. If the outer casing is made from a number of parts, including but not limited to the shell, cap, and base, these parts may be made from the same material or different materials.

[0040] In some embodiments, the present invention relates to a cartridge as defined above, wherein the shell and / or base of the outer casing comprises high-density polyethylene, polyethylene, polypropylene, polyoxymethylene, metal, such as aluminum, acrylonitrile-butadiene-styrene, or combinations and mixtures thereof.

[0041] In some embodiments, the present invention relates to a cartridge as defined above, wherein the cap of the outer casing comprises low-density polyethylene, polyethylene, elastomer, silicone, ethylene propylene diene monomer rubber, metal / elastomer combinations, and / or combinations and mixtures thereof.

[0042] An advantage of the present invention is that the volume of the cartridge can be adapted to the requirements of the nebulizer as needed. The volume of the outer casing can be adapted to accommodate the size of the foldable inner tube. The outer casing may have any volume required by the nebulizer, as long as the volume of the outer casing is sufficient to include the foldable inner tube.

[0043] In some embodiments of the present invention, the outer casing has a volume in the range of about 0.1 ml to 200 ml. In certain embodiments, the volume of the outer casing is between about 0.5 ml and about 50 ml. In certain embodiments, the volume of the outer casing is between about 1 ml and 10 ml.

[0044] The volume of the foldable inner bag is generally smaller than the volume of the casing so that the foldable inner tube fits inside the outer casing. More specifically, the volume of the foldable inner tube is between 0.1 and 0.9 times the volume of the dimensionally stable outer casing. In some embodiments, the volume is about 0.3 to 0.7 times the volume of the outer casing. In some embodiments, the volume of the foldable inner tube is selected from 0.1, 0.2, 0.3, 0.4, 0.5, 0.7, 0.8, and 0.9 times the volume of the outer casing.

[0045] In some embodiments of the present invention, the inner tube has a volume in the range of about 2 ml to about 8 ml. In some embodiments, the volume of the inner tube is selected from 2 ml, 2.5 ml, 3 ml, 3.5 ml, 4 ml, 4.5 ml, 5 ml, 5.5 ml, 6 ml, 6.5 ml, 7 ml, 7.5 ml, and 8 ml. In some specific embodiments, the volume of the inner tube is about 3 ml.

[0046] The deformation element may be provided in any suitable form. Preferably, the deformation element is provided in the form of a projection or a number of projections. The projection may be of any suitable shape. In some embodiments, the projection may take the form of a guide wall. In different embodiments, the deformation element may be a recess in the form of a guide channel or groove that receives a weld joint, for example.

[0047] If the deformation element is provided in the form of a projection, it is preferable that it be oriented parallel to the principal axis (X) of the inner tube. In some specific embodiments, at least one deformation element is oriented on the principal axis (X) of the inner collapsible tube.

[0048] In some embodiments, the deformation element is a projection or a pair of projections. In a preferred embodiment, the pair of projections is pin-shaped. Accordingly, in a particular embodiment, the present invention relates to a cartridge as defined above, and the deformation element is provided in the form of at least one pin (15) extending from the base of the outer casing. The pin may have any reasonable shape, however, it is preferred that the pin generally has a round shape. In a preferred embodiment, the deformation element is provided in the form of a pin, and the pin has a circular cross-section.

[0049] In preferred embodiments, the deformation element is a projection extending from the bottom of the dimensionally stable casing toward the opening of the dimensionally stable casing, such as a pin or a plurality of pins as defined above. In some embodiments of the present invention, where at least one deformation element is provided in the form of at least one pin, it is preferable that at least one pin is oriented parallel to the principal axis (X) of the inner tube.

[0050] In some embodiments of the present invention, the deformation element is provided in the form of a plurality of pins. Any suitable number of pins may be used. The number and arrangement of the pins will allow the deformation to be adapted and adjusted as needed, depending on the foldable inner bag. A particular suitable arrangement is based on three pins. Accordingly, in one embodiment, the present invention relates to a cartridge as defined above, and the deformation element is provided in the form of three pins. In a particular embodiment, the three pins are arranged on a base plate as defined above, and as a result, when the weld seam comes into contact and deforms, one pin is located on one broad side (25) of the weld seam and two pins are located on the opposite broad side of the weld seam.

[0051] As already noted, it is preferable that the deformation element does not come into contact with the non-welded portion of the foldable inner bag. In such embodiments, in some parts of the present invention, the deformation element does not substantially come into contact with the foldable sidewall of the foldable tube. In preferred embodiments, the deformation element comes into contact only with the welded seams of the foldable inner tube. In particular, the deformation element is preferably designed not to substantially reduce the internal volume of the foldable inner tube.

[0052] Accordingly, in some embodiments of the present invention, the present invention relates to a cartridge as defined above, wherein the deformation element, when in contact with the welded seam of the foldable tube, does not substantially reduce the internal volume of the foldable tube.

[0053] The cartridge according to the present invention is intended for use in an inhalation device for administering a medically active liquid. As such, in one embodiment of the present invention, the cartridge, and more specifically a foldable inner bag, comprises a medically active liquid. The medically active liquid is to be administered by an inhaler.

[0054] The cartridge is suitable for any medically active liquid administered by inhaler. In some embodiments, this medically active liquid is a liquid active agent. In other embodiments, the medically active liquid comprises a pharmacoactive component and a liquid vehicle. The medically active liquid may be any suitable liquid of any kind.

[0055] In certain embodiments, the present invention relates to a cartridge as defined above, comprising a medically active liquid, wherein the medically active liquid comprises at least one pharmaceutically active component and a liquid vehicle.

[0056] Liquid vehicles suitable for medically active compounds are known to those skilled in the art. Such liquid vehicles include solutions, suspensions, and emulsions. Preferred liquid vehicles include a solvent. In some embodiments, the liquid vehicle comprises water, ethanol, polyethylene glycol, liquid fatty acids, oils, particularly natural oils, and semi-fluorinated alkanes, with at least one solvent selected from this group. In certain preferred embodiments, the liquid vehicle comprises a solvent, the solvent being ethanol.

[0057] In another aspect of the present invention, the present invention is a method for assembling a cartridge as defined above, a) A step of providing a dimensionally stable outer casing with a foldable inner tube and a deformation element, b) A step of introducing an inner tube into an outer casing, thereby bringing the welded joint of the inner tube into contact with a deformation element of the outer casing and deforming the welded joint of the inner tube, c) The step of filling the inner tube with a medically active liquid, d) Optionally, a step of sealing the container after filling. Regarding methods for providing such a system.

[0058] In a preferred embodiment, step (d) is not optional.

[0059] In other embodiments, the present invention relates to an inhalation device (100) adapted to include a cartridge as defined above. In particular embodiments, the present invention relates to a kit comprising an inhalation device (100) adapted to include a cartridge as defined above, and a cartridge according to any one of the prior claims. The cartridge may be removable or permanently provided in the inhalation device.

[0060] The inhalation device may be any type of liquid inhalation device. In a preferred embodiment, the inhalation device is a soft mist inhalation device, preferably a soft mist inhalation device equipped with an impact nozzle.

[0061] In other embodiments, the present invention is a method for assembling a cartridge as defined above, a) A step of providing an inner tube and a dimensionally stable outer casing comprising deformation elements, b) A step of introducing an inner tube into an outer casing, thereby bringing the welded joint of the inner tube into contact with a deformation element of the outer casing and deforming the welded joint of the inner tube, c) The step of filling the inner tube with a medically active liquid, d) Optionally, a step of sealing the container after filling. Regarding methods for providing such a system.

[0062] The present invention further relates to the following numbered embodiments.

[0063] 1. A cartridge (1) for an inhalation device for generating and administering a medically active liquid in an aerosolized form, -Dimensionally stable outer casing (10), -Deformation element (11), - A collapsible inner tube (20) for holding a medically active fluid, An outlet end (21) having an outlet opening (22), and The closed end (23) opposite to the outlet end defines the main axis (X) of the inner tube connecting the outlet opening and the closed end (center), The closed end of the tube is closed by a welded joint (24) oriented laterally with respect to the main axis of the inner tube (preferably substantially perpendicular to it). Closed end(21) It has a foldable inner tube (20) and Equipped with, When the cartridge is assembled, the foldable inner tube is located inside the outer casing. In cartridges, In the assembled state, the deformation element (11) contacts the welded joint such that the welded joint deforms and deviates from the transverse line (L) with respect to the main axis of the inner tube due to contact between the welded joint and the deformation element. This relates to a cartridge characterized by the following features.

[0064] 2. The outer casing is - A shell (12) having an exit opening and a base opening on the opposite side, - A cap (13) fitted to attach to the exit opening of the shell, - A base (14) fitted to attach to the base opening of the shell and A cartridge according to Embodiment 1, comprising the following features.

[0065] 3. The deformation element is provided on the base of the outer casing, as described in Embodiment 2 of the cartridge.

[0066] 4. The cartridge according to Embodiment 2 or 3, wherein the deformation element is provided in the form of at least one pin (15) (preferably having a circular cross-section) extending from the base of the outer casing (towards the exit opening).

[0067] 5. The cartridge according to Embodiment 4, wherein at least one pin is oriented parallel to the main axis (X) of the inner tube.

[0068] 6. The cartridge according to embodiment 4 or 5, wherein the deformation element is provided in the form of multiple pins.

[0069] 7. The deformation element is provided in the form of three pins, as described in any one embodiment of Embodiments 4 to 6.

[0070] 8. The cartridge according to Embodiment 7, wherein the three pins are positioned on a base plate such that when the welded joint comes into contact and deforms, one pin is positioned on the broad side (25) of the welded joint and the other two pins are positioned on the broad side opposite the welded joint.

[0071] 9. The cartridge according to Embodiment 3, wherein the deformation element is provided in the form of a groove provided on the base of the outer casing (to receive the welded joint of the foldable tube).

[0072] 10. A cartridge according to any one embodiment of Embodiments 1 to 9, wherein the deformation element contacts only the welded seams of the foldable tube and does not substantially contact the foldable side walls of the foldable tube.

[0073] 11. A cartridge according to any one embodiment of Embodiments 1 to 10, wherein the deformation element, when in contact with the welded seam of the foldable tube, does not substantially reduce the internal volume of the foldable tube.

[0074] 12. A cartridge according to any one embodiment of Embodiments 1 to 11, wherein the foldable tube comprises a pouch portion (26) and a collar portion (27), the collar portion having an outlet opening and being adapted to be attached to the shell of the outer casing of the cartridge.

[0075] 13. The cartridge according to Embodiment 12, wherein the foldable tube pouch portion comprises polyethylene, more specifically high-density polyethylene, nylon, ethylene vinyl alcohol (EVOH), polyamide, and metals such as polypropylene, aluminum, or a mixture thereof.

[0076] 14. The cartridge according to embodiment 12 or 13, wherein the collapsible tube color portion comprises polyethylene, high-density polyethylene, polylactic acid, and / or polyoxymethylene.

[0077] 15. A cartridge according to any one embodiment of Embodiments 2 to 14, wherein the outer casing shell comprises high-density polyethylene, polyethylene, polypropylene, polyoxymethylene, metal, such as aluminum, acrylonitrile-butadiene-styrene, or combinations and mixtures thereof.

[0078] 16. A cartridge according to any one embodiment of Embodiments 2 to 15, wherein the cap of the outer casing comprises low-density polyethylene, polyethylene, elastomer, silicone, ethylene propylene diene monomer rubber, metal / elastomer combinations, and / or combinations and mixtures thereof.

[0079] 17. A cartridge according to any one embodiment of Embodiments 2 to 16, wherein the base of the outer casing comprises high-density polyethylene, polyethylene, polypropylene, polyoxymethylene, metal, such as aluminum, acrylonitrile-butadiene-styrene, or combinations and mixtures thereof.

[0080] 18. A cartridge according to any one embodiment of Embodiments 1 to 17, wherein the outer casing has a volume in the range of approximately 0.1 ml to approximately 200 ml, optionally in the range of approximately 0.5 ml to approximately 50 ml, and optionally in the range of approximately 1 ml to 10 ml.

[0081] 19. A cartridge according to any one of embodiments 1 to 18, wherein the inner tube has a volume in the range of approximately 2 ml to approximately 8 ml.

[0082] 20. A cartridge according to any one embodiment of Embodiments 1 to 19, wherein the radially curved welded joint morphology has a deviation of up to 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, or 5 mm from the ideal straight line at the furthest point.

[0083] 21. A cartridge according to any one embodiment of Embodiments 1 to 20, comprising at least one pharmaceutically active ingredient and a liquid vehicle.

[0084] 22. The cartridge according to Embodiment 21, wherein the liquid vehicle comprises at least one solvent selected from the group consisting of water, ethanol, polyethylene glycol, liquid fatty acids, oils, more specifically natural oils, and semi-fluorinated alkanes.

[0085] 23. An inhalation device (adapted to include a cartridge according to any one of Embodiments 1 to 22), the inhalation device comprising a cartridge according to any one of Embodiments 1 to 22.

[0086] 24. A method for assembling the cartridges described in Embodiments 1 to 22, a) A step of providing an inner tube and a dimensionally stable outer casing comprising deformation elements, b) A step of introducing an inner tube into an outer casing, thereby bringing the welded joint of the inner tube into contact with a deformation element of the outer casing and deforming the welded joint of the inner tube, c) The step of filling the inner tube with a medically active liquid, d) Optionally, a step of sealing the container after filling. A method for providing this.

[0087] Detailed description of the drawing Figure 1 shows a schematic diagram of the cartridge (1) for the inhalation device (30) in its assembled form. The cartridge (1) comprises a dimensionally stable outer casing (10) which includes at least one outer shell (12) and a cap (13) that closes the cartridge (1). The foldable inner tube (20) is not visible in this figure.

[0088] Figures 2A and 2B show cross-sections of a cartridge (1) for an inhalation device (30) according to the present invention. Figure 2A shows the assembled inhalation device (1). In the illustrated embodiment, the dimensionally stable outer casing (10) of the cartridge (1) comprises a base (14), an outer shell (12), and a cap (13). The base includes a deformation element (11) in the form of a pin (15). A foldable inner tube (20) is inserted into the dimensionally stable outer casing (10), which is immobilized by the cap (13). The foldable inner tube has an outlet end (21) with an outlet opening (22) that interacts with the cap (13) of the outer casing. The closed end (23) is closed by a welded seam (24) in which the deformation element (11) comes into contact, causing a deviation from a straight line. The main axis (X) of the cartridge is schematically drawn to show the deviation of the welded seam. The foldable inner tube (20) comprises a pouch portion (26) on one side, filled with a medically active liquid and ending at a welded seam, and a collar portion (27) on the other side. The collar portion indicates the position of the outlet end and provides an outlet opening.

[0089] Figure 2B shows the same embodiment of the cartridge (1) in a disassembled state. The figure shows in detail a cross-section of the base (14) of the dimensionally stable outer casing (10) which has a deformation element (11) in the form of a pin (15). The figure further gives a better depiction of the foldable inner tube (20) which is still inserted into the shell (12) of the outer casing (10). The foldable inner tube has an outlet end (21) with an outlet opening (22), a closed end (23) with a welded seam (24), and a pouch portion (26).

[0090] Figure 2C shows another drawing of the cartridge elements in a formalized form, rather than in cross-sectional form. The figure depicts the different components of the cartridge (1) before assembly, namely the base (14), the foldable inner bag (20), the shell (12), and the cap (13), oriented along the cartridge's main axis (X).

[0091] Figures 3A, 3B, and 3C show the base (14) at different angles with a deformation element (11) in the form of a pin (15) that interacts with the broad side (25) of the welded seam (24) of the foldable inner tube (20). All figures show that the welded seam (24) deforms into a radially curved form that deviates from the ideal transverse line (L) with respect to the principal axis (X). Figure 3C illustrates the deviation by depicting the transverse line (L) as an example.

[0092] Figure 4 shows an inhaler (30) with an inserted cartridge (1) according to the present invention. [Explanation of Symbols]

[0093] 1 cartridge 10 Dimensionally stable outer casing 11 deformation elements 12 shells 13 caps 14 Base 15 pins 20 foldable inner tubes 21 Outlet end 22 Exit opening 23 Closed end 24 Welded joints 25. Wide side of welded joint 26 Pouch section 27 Color section 30 Inhaler X main axis L-shaped crossing

Claims

1. A cartridge (1) for an inhalation device for generating and administering a medically active liquid in an aerosolized form, wherein the cartridge is - Dimensionally stable outer casing (10), - Deformation element (11), - A collapsible inner tube (20) for holding the aforementioned medically active liquid, An outlet end (21) having an outlet opening (22), and The closed end (23) opposite to the outlet end, wherein the outlet opening and the closed end (center) define the main axis (X) of the inner tube connecting the outlet opening and the closed end of the tube, The closed end of the tube is closed by a welded joint (24) oriented laterally with respect to the main axis of the inner tube (preferably substantially perpendicular to it). closed end It has a foldable inner tube and Equipped with, When the cartridge is assembled, the foldable inner tube is located inside the outer casing. In cartridges, In the assembled state, the deformation element (11) contacts the welded joint such that the welded joint deforms and deviates from the transverse line (L) of the inner tube relative to the main axis due to contact between the welded joint and the deformation element. A cartridge characterized by the following features.

2. The outer casing is, - A shell (12) having an exit opening and a base opening on the opposite side, - A cap (13) fitted to be attached to the outlet opening of the shell, - A base (14) adapted to be attached to the base opening of the shell and The cartridge according to claim 1, comprising:

3. The cartridge according to claim 2, wherein the deformation element is provided on the base of the outer casing.

4. The cartridge according to claim 2 or 3, wherein the deformation element is provided in the form of at least one pin (15).

5. The cartridge according to claim 3, wherein the deformation element is provided in the form of a groove provided on the base of the outer casing.

6. The cartridge according to any one of claims 1 to 5, wherein the deformation element contacts only the welded seam of the foldable inner tube and does not substantially contact the foldable side wall of the foldable inner tube.

7. The cartridge according to any one of claims 1 to 6, wherein the deformation element, when in contact with the welded seam of the foldable inner tube, does not substantially reduce the internal volume of the foldable inner tube.

8. The cartridge according to any one of claims 1 to 7, wherein the foldable inner tube comprises a pouch portion (26) and a collar portion (27), the collar portion comprising the outlet opening and being adapted to be attached to the shell of the outer casing of the cartridge.

9. The cartridge according to any one of claims 1 to 8, wherein the outer casing has a volume in the range of about 0.1 ml to about 200 ml, optionally in the range of about 0.5 ml to about 50 ml, and optionally in the range of about 1 ml to 10 ml.

10. The cartridge according to any one of claims 1 to 9, wherein the inner tube has a volume in the range of about 2 ml to about 8 ml.

11. The cartridge according to any one of claims 1 to 10, wherein the welded joint has a radially curved shape with a deviation of up to 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, or 5 mm from the ideal straight line at the furthest point.

12. The cartridge according to any one of claims 1 to 11, wherein the medically active liquid comprises at least one pharmaceutically active component and a liquid vehicle.

13. The cartridge according to claim 12, wherein the liquid vehicle comprises at least one solvent selected from the group consisting of water, ethanol, polyethylene glycol, liquid fatty acids, oils, more specifically natural oils, and semi-fluorinated alkanes.

14. An inhalation device adapted to include a cartridge according to any one of claims 1 to 13, the inhalation device comprising a cartridge according to any one of claims 1 to 13.

15. A method for assembling the cartridges described in claims 1 to 13, a) A step of providing an inner tube and a dimensionally stable outer casing comprising deformation elements, b) A step of introducing the inner tube into the outer casing, thereby bringing the welded joint of the inner tube into contact with the deformation element of the outer casing and deforming the welded joint of the inner tube, c) The step of filling the inner tube with a medically active liquid, d) Optionally, a step of sealing the container after filling. A method for providing this.

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