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EP-4735352-A1 - CARTRIDGE FOR INHALATION DEVICE

EP4735352A1EP 4735352 A1EP4735352 A1EP 4735352A1EP-4735352-A1

Abstract

The invention provides a cartridge (1) for an inhalation device for the generation and administration of a medically active liquid (2) in aerosolized form, the cartridge comprising - a dimensionally stable outer casing (10), and - a collapsible inner tube (20) for holding the medically active liquid, being located inside the outer casing in the assembled state of the cartridge, wherein the collapsible inner tube comprises an outlet end (21) having an outlet opening (22) and a closed end (23) opposite of the outlet end, the outlet opening and the (the center of the) closed end defining a main axis (X) of the inner tube connecting the outlet opening and closed end of the tube, wherein the closed end of the tube being closed by a welded seam (24) oriented transverse (preferably substantially perpendicular) to the main axis of the inner tube; and wherein the outer casing comprises a deformation element (11) contacting the welded seam (in the assembled state of the cartridge) such that the welded seam is deformed to a radially curved form by the contact between the welded seam and the deformation element.

Inventors

  • Rawert, Jürgen
  • MADDEN, STEVEN

Assignees

  • InvoX Belgium NV

Dates

Publication Date
20260506
Application Date
20240627

Claims (15)

  1. 1. A cartridge (1) for an inhalation device for the generation and administration of a medically active liquid in aerosolized form, the cartridge comprising - a dimensionally stable outer casing (10), - a deformation element (11), and - a collapsible inner tube (20) for holding the medically active liquid comprising: an outlet end (21) having an outlet opening (22) and a closed end (23) opposite of the outlet end, wherein the outlet opening and the (the center of the) closed end defining a main axis (X) of the inner tube connecting the outlet opening and closed end of the tube; wherein the closed end of the tube is closed by a welded seam (24) oriented transverse (preferably substantially perpendicular) to the main axis of the inner tube; wherein in the assembled state of the cartridge the collapsible inner tube is located inside the outer casing; characterized in that in the assembled state the deformation element (11) contacts the welded seam such that the welded seam is deformed to deviate from a traversal line (L) to the main axis of the inner tube by the contact between the welded seam and the deformation element.
  2. 2. The cartridge according to claim 1, wherein the outer casing comprises - a shell (12) comprising an outlet opening and an opposite base opening; - a cap (13) adapted to be attached to the outlet opening of the shell; and - a base (14) adapted to be attached to the base opening of the shell.
  3. 3. The cartridge according to claim 2, wherein the deformation element is provided on the base of the outer casing.
  4. 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. 5. The cartridge according to claim 3, wherein the deformation element is provided in the form of groove provided on the base of the outer casing.
  6. 6. The cartridge according to any one of the preceding claims, wherein the deformation element contacts the welded seam of the collapsible tube only and does not substantially contact the collapsible sidewalls of the collapsible tube.
  7. 7. The cartridge according to any one of the preceding claims, wherein the deformation element upon contact with the welded seam of the collapsible tube does not substantially reduce the inner volume of the collapsible tube.
  8. 8. The cartridge according to any one of the preceding claims, wherein the collapsible tube comprises a pouch portion (26) and a collar portion (27), wherein the collar portion comprises the outlet opening and is adapted to be attached to the shell of the outer casing of the cartridge.
  9. 9. The cartridge according to any one of the preceding claims, wherein the outer casing has a volume in the range about 0.1 to about 200 mL, optionally about 0.5 to about 50 ml, further optionally between about 1 mL to 10 ml.
  10. 10. The cartridge according to any one of the preceding claims, wherein the inner tube has a volume in the range of from about 2 to about 8 mL.
  11. 11. The cartridge according to any one of the preceding claims, wherein the welded seam is in a radially curved form comprising a deviation of up to 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 an ideal straight line at the furthest point.
  12. 12. The cartridge according to any one of the preceding claims, wherein the medically active liquid comprises at least one pharmaceutically active ingredient and a liquid vehicle.
  13. 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, in particular natural oils, and semifluorinated alkanes.
  14. 14. An inhalation device adapted to comprise a cartridge according to any of the preceding claims comprising a cartridge according to any one of the preceding claims.
  15. 15. A method for the assembly of a cartridge according to any one of claims 1 to 13, the method comprising the steps of a] providing an inner tube and a dimensionally stable outer casing comprising a deformation element; b] introducing the inner tube into outer casing, thereby contacting the welded seam of the inner tube with the deformation element of the outer casing and deforming the welded seam of the inner tube; c] filling of the inner tube with the medically active liquid; d] optionally sealing the container after filling.

Description

CARTRIDGE FOR INHALATION DEVICE FIELD OF THE INVENTION The present invention relates to the field of inhalation devices for medically active liquids. In particular, the invention relates to a cartridge for an inhalation device for the generation and administration of 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 relates to an inhalation device comprising such cartridge as well as a method for the assembly of such cartridge. BACKGROUND OF THE INVENTION Nebulizers or other aerosol generators for liquids have long been known from the art. Amongst others, such devices are used in medical science and therapy. There, they serve as inhalation devices for the application of active ingredients in the form of aerosols, i.e., small liquid droplets embedded in a gas. Such an inhalation device is known, e.g., from document EP 0 627 230 Bl. Essential components of this inhalation device are a reservoir, often in the form of a cartridge, in which the liquid that is to be aerosolized is contained; a pumping device for generation of a pressure being sufficiently high for nebulizing the liquid; as well as an atomizing device in the form of a nozzle. By means of the pumping device, the liquid is drawn in a discrete amount, i.e., not continuously, from the reservoir and fed to the nozzle. The pumping device works without propellant and generates pressure mechanically. Cartridges for holding the medically active liquids are, for example, described in US 2004/0143235 Al. The document discloses a container for a medicinal liquid, the container being gas-tight and liquid-tight so that it is storable over many months. The container includes a collapsible foil bag on which a flange, which is stable in respect of shape, is disposed. The flange is designed for fitting onto a discharge connection member. The container can be disposed in a casing which is stable in respect of shape. The medicinal liquid does not come into contact with air and is protected from the effect of light. The medicinal liquid may be dispensed from the foil bag in many partial quantities over a prolonged period of time, with a respective partial amount thereof being converted into an aerosol by means of an atomizer. WO 2009/115200 Al discloses a reservoir for a nebulizer, a nebulizer and a method of filling a reservoir. To avoid undesirable rises in pressure a fluid chamber of the reservoir is pre-collapsed and filled with an initial amount of fluid which is less than the maximum volume of the fluid chamber. A device may be used to pre-collapse the fluid chamber, wherein the device may have at least manipulating or abutment element. As a result of the external placement of the abutment elements against the wall of the fluid chamber or the deformation thereof, the actual volume of the fluid chamber available during the filling with the fluid is reduced, i.e., it is less than the maximum volume of the fluid chamber. This results in the desired pre-collapsing. A technical problem associated with the withdrawal of a the medically active fluid from such fluid bags or chambers, especially when withdrawn in a plurality of discrete small amounts, however, is the formation of an unwanted underpressure inside the foil bag or chamber which can potentially affect the precise dosing of the medically active liquid as well as the withdrawal of the intended total amount of medically active liquid to be provided by the fluid bag or chamber. It is thus an object of the present invention to provide for a cartridge for an inhalation device that allows for the storage of a broad variety of medically active liquids including aqueous or organic liquids and for the withdrawal or dispensing thereof, especially in a plurality of discrete steps. A further object of the present invention is to provide a cartridge for an inhalation device that allows for the withdrawal or dispensing of a medically active liquid in a large number of precise consecutive aliquots or doses. Further objects of the invention will be clear on the basis of the following description of the invention, examples and claims. SUMMARY OF THE INVENTION In a first aspect, the invention relates to a cartridge (1) for an inhalation device for the generation and administration of a medically active liquid (2) in aerosolized form, the cartridge comprising - a dimensionally stable outer casing (10), - at least one deformation element (11), and - a collapsible inner tube (20) for holding the medically active liquid comprising: an outlet end (21) having an outlet opening (22) and a closed end (23) opposite of the outlet end, wherein the outlet opening and the (the center of the) closed end defining a main axis (X) of the inner tube connecting the outlet opening and closed end of the tube; wherein the closed end of the tube is closed by a welded seam (24) oriented transverse (preferably substantial