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CN-122003265-A - Inhalation device with integral piston

CN122003265ACN 122003265 ACN122003265 ACN 122003265ACN-122003265-A

Abstract

The invention provides a hand-held inhalation device for delivering a medically active fluid (F) in atomized (nebulized) form for inhalation therapy, comprising (a) a housing (1) having a user-facing side, (b) a nozzle (6) for generating a nebulized aerosol by collision of at least two liquid jets, the nozzle (6) being firmly attached to the user-facing side of the housing (1) so as to be immobilized with respect to the housing (1), (c) a fluid reservoir (2) arranged within the housing (1) for containing the medically active fluid, and (d) a pumping unit arranged within the housing (1), the pumping unit comprising a stand pipe and a holder in the form of a one-piece unit.

Inventors

  • J. Lovett
  • S horse steps on
  • S. Dudley

Assignees

  • 英沃克斯比利时公司

Dates

Publication Date
20260508
Application Date
20241004
Priority Date
20231004

Claims (16)

  1. 1. A hand-held inhalation device for delivering a medically active fluid (F) in an atomized form for inhalation therapy, comprising: (a) A housing (1) having a user facing side; (b) -a nozzle (6) for generating a nebulized aerosol by impingement of at least two liquid jets, the nozzle (6) being firmly attached to the user facing side of the housing (1) so as to be stationary with respect to the housing (1); (c) A fluid reservoir (2) arranged within the housing (1) for containing the medically active fluid, and (D) A pumping unit arranged within the housing (1), the pumping unit having: -an upstream end fluidly connected to the fluid reservoir (2), and -A downstream end fluidly connected to the nozzle (6); wherein the pumping unit is adapted to pump the medically active fluid (F) from the fluid reservoir (2) to the nozzle (6); Wherein the pumping unit further comprises: (i) A riser (5) having an upstream end and a downstream end, wherein the riser (5) is adapted to function as a piston in the pumping unit; (ii) A retainer (10) downstream of the riser, firmly attached to the user facing side of the housing (1) so as to be stationary relative to the housing (1) for retaining the riser; (iii) A hollow barrel (9) located upstream of the riser (5), wherein the upstream end of the riser (5) is inserted into the barrel (9) such that the barrel (9) is longitudinally movable on the riser (5), and (Iv) Lockable means (7) for storing potential energy when locked and for releasing stored energy when unlocked, the means (7) being arranged outside the cartridge (9) and mechanically coupled to the cartridge (9) such that unlocking the means (7) results in a push-on longitudinal movement of the cartridge (9) towards the downstream end of the pumping unit; wherein the retainer (10) and the riser (5) are a one-piece unit.
  2. 2. Inhalation device according to claim 1, wherein the holder (10) and the riser (5) comprise an injection moldable polymer material, optionally at least one thermoplastic injection moldable polymer material.
  3. 3. Inhalation device according to any of the preceding claims, wherein the holder (10) and the riser (5) comprise the same injection mouldable polymeric material.
  4. 4. A high pressure medical pumping device according to claim 2 or 3, wherein the injection mouldable polymeric material is selected from the group consisting of Polyoxymethylene (POM), polyetheretherketone (PEEK) and polyphenylene ether (PPO/PPE), preferably PEEK.
  5. 5. The high pressure medical pumping device according to any of claims 2 to 4, wherein the injection moldable polymer material is a mixture or blend comprising at least one injection moldable material selected from the group consisting of PEEK, PPO/PPE and POM and at least one further injection moldable polymer material selected from the group consisting of acrylonitrile butadiene styrene copolymer (ABS), acrylonitrile Styrene Acrylate (ASA), styrene acrylonitrile copolymer (SAN), polyacrylic acid (such as polymethyl methacrylate (PMMA)), acrylonitrile butadiene styrene copolymer (ABS), polyamide, polylactic acid (polylactide, PLA), polybenzimidazole (PBI), polycarbonate (PC), polyethersulfone (PES), polyoxymethylene (POM), polyetheretherketone (PEEK), polyetherimide (PEI), polyethylene (PE) (such as Ultra High Molecular Weight Polyethylene (UHMWPE), high Density Polyethylene (HDPE), medium density polyethylene (mdpp), low density polyethylene (PP), polyvinylidenecarbon (PPO), polyvinylidenecarbon (PPS).
  6. 6. The high pressure medical pumping device according to any of claims 2 to 5, wherein the at least one injection moldable material is Polyetheretherketone (PEEK).
  7. 7. High pressure medical pumping device according to any of the preceding claims, wherein the one-piece unit comprising the riser (5) and the retainer (10) comprises a composite material comprising an injection moldable material.
  8. 8. A high pressure medical pumping device according to any of the preceding claims, wherein the riser consists essentially of the injection mouldable material.
  9. 9. The inhalation device of any preceding claim, wherein the standpipe comprises a fluid channel fluidly connecting the upstream end of the standpipe with the downstream end of the standpipe for delivering the medically active fluid, optionally wherein the diameter of the fluid channel is selected in the range of about 0.1mm to about 1 mm.
  10. 10. An inhalation device as claimed in any preceding claim, wherein the diameter of the standpipe is selected in the range of from about 1mm to about 3 mm.
  11. 11. An inhalation device as claimed in any preceding claim, wherein the length of the standpipe is selected in the range of from about 10mm to about 30 mm.
  12. 12. An inhalation device as claimed in any preceding claim, wherein the nozzle comprises an impingement nozzle.
  13. 13. Inhalation device according to any of the preceding claims, wherein the pumping unit is a high pressure pumping unit adapted to expel the fluid (F) at a pressure of at least 50 bar.
  14. 14. Inhalation device according to any of the preceding claims, wherein the means (7) for storing potential energy is a spring having a load of at least 40N in a deflected state.
  15. 15. An inhalation device according to any preceding claim, adapted to discontinuously administer the nebulized pharmaceutically active aerosol in discrete units, wherein one unit is administered per pumping cycle, optionally wherein a unit of the aerosol contains 2 μl to 150 μl of liquid phase.
  16. 16. A hand-held inhalation device for delivering a medically active fluid (F) in an atomized form for inhalation therapy, comprising: (a) A housing (1) having a user facing side, the housing further comprising a container configured for attaching a riser (5); (b) -a nozzle (6) for generating a nebulized aerosol by impingement of at least two liquid jets, the nozzle (6) being firmly attached to the user facing side of the housing (1) so as to be stationary with respect to the housing (1); (c) A fluid reservoir (2) arranged within the housing (1) for containing the medically active fluid, and (D) A pumping unit arranged within the housing (1), the pumping unit having: -an upstream end fluidly connected to the fluid reservoir (2), and -A downstream end fluidly connected to the nozzle (6); wherein the pumping unit is adapted to pump the medically active fluid (F) from the fluid reservoir (2) to the nozzle (6); Wherein the pumping unit further comprises: (i) A riser (5) integrally comprising: A riser section having an upstream end and a downstream end; A retainer section (10) at a downstream end of the riser section, the retainer section being attached to the container of the housing and fixedly attaching the riser (5) to the user facing side of the housing (1) so as to be stationary relative to the housing (1); (ii) A hollow barrel (9) located upstream of the riser (5), wherein the upstream end of the riser (5) is inserted into the barrel (9) such that the barrel (9) is longitudinally movable on the riser section, and (Iii) Lockable means (7) for storing potential energy when locked and for releasing stored energy when unlocked, the means (7) being arranged outside the cartridge (9) and mechanically coupled to the cartridge (9) such that unlocking the means (7) results in a push-on longitudinal movement of the cartridge (9) towards the downstream end of the pumping unit.

Description

Inhalation device with integral piston Technical Field The present invention relates to the field of inhalation devices for the administration of a medically active fluid in an aerosolized form for inhalation therapy. In particular, the invention relates to a hand-held inhalation device comprising a pumping unit having a stand pipe and a corresponding holder in the form of a one-piece unit. The invention also relates to a corresponding method. Background Pumping devices or units for medical devices, in particular for pumping medical fluids, have long been known in the prior art. Such devices are found, for example, in inhalation devices for administering medical fluids or active ingredients in aerosol form (i.e. in the form of small droplets embedded in a gas). Such inhalation devices are known, for example, from WO 91/14468 A1. The essential components of such inhalation devices are a reservoir containing the liquid to be nebulized, pumping means for generating a sufficiently high pressure for nebulization, and a nebulizing device in the form of a nozzle. By means of pumping means, liquid is drawn from the reservoir in discrete amounts (i.e. discontinuously) and fed to the nozzle. The pumping device works without the need for a propellant and generates pressure mechanically. This document further discloses an embodiment wherein the pressure in the pumping chamber connected to the housing is generated by the movement of a movable hollow piston. The piston is movably arranged inside a stationary cylinder or pumping chamber. The inlet (arranged upstream) of the hollow piston is fluidly connected to the interior of the reservoir (reservoir pipe section). The end of the hollow piston (arranged downstream) opens into the pumping chamber. Further, a check valve that suppresses backflow of the liquid into the reservoir is arranged inside the tip end of the piston. To fill the piston, the piston is directly connected to the reservoir by its upstream end. By pulling out the piston of the pumping chamber provided inside the hollow cylinder, the internal volume of the pumping chamber is enlarged, so that an increased pressure shortage is established inside the pumping chamber. The pressure is transferred through the hollow piston into the reservoir such that liquid is drawn from the reservoir into the piston. At the same time, the valve is open at its end, since the pressure inside the reservoir is higher than the pressure inside the (still empty) pumping chamber. The pumping chamber is being filled. At the same time, the spring is loaded and locked at the end of the movement when the movable piston has reached its bottom dead centre (in the case of a vertically arranged device) and the pumping chamber is filled. An additional example of a pumping device for generating a discrete amount of medical fluid in pressurized form for inhalation is disclosed in US 2014/0076308 A1. This document discloses a specific inhaler having a pumping unit with a pressure chamber and a delivery tube acting as a piston within the pressure chamber. The delivery tube has a one-way valve positioned at its downstream end within the pressure chamber. The piston is arranged inside a compression spring designed as a helical spring, so that its outer diameter is limited. Furthermore, the piston is designed with a small inner diameter (usually also the outer diameter) due to the typically small volume (e.g. 15 μl). Such a generally small internal diameter of the delivery tube (or in other words of the movable piston), for example 0.3mm to 1.0mm, together with the small size of the non-return valve arranged therein, is a disadvantage of the described construction. The small diameter results in a high flow resistance so that, in particular, a medium of higher viscosity can only flow very slowly into and through the piston. In other words, the described construction is particularly suitable for low viscosity (aqueous) liquids and for spraying low doses of such liquids. In addition, there are difficulties in producing a sufficiently tight small diameter check valve. An improved inhalation device using an immovable piston is disclosed in WO 2018/197730 A1. Which overcomes some of the disadvantages of the prior art described above. Furthermore, the pumping unit of the above-described device is designed for generating discrete portions of the medical fluid to be atomized under the high pressure conditions necessary for atomizing the respective medical fluid, which is typically in the range of about 10 bar to about 100 bar and above. The components of the respective pumping unit, in particular the respective piston for generating the pressure, are thus made of a mechanically stable and pressure-resistant material, typically a metal such as stainless steel. However, this is particularly relevant to the above-mentioned space constraints and results in the need to provide precisely machined metal parts which significantly increase the overall manufacturing c