Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/0065—Inhalators with dosage or measuring devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
  • A61M11/005—Sprayers or atomisers specially adapted for therapeutic purposes using ultrasonics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
  • A61M11/06—Sprayers or atomisers specially adapted for therapeutic purposes of the injector type
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/0065—Inhalators with dosage or measuring devices
  • A61M15/0066—Inhalators with dosage or measuring devices with means for varying the dose size
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/0085—Inhalators using ultrasonics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/22—Valves or arrangement of valves
  • A61M39/24—Check- or non-return valves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/02—Inhalators with activated or ionised fluids, e.g. electrohydrodynamic [EHD] or electrostatic devices; Ozone-inhalators with radioactive tagged particles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/22—Valves or arrangement of valves
  • A61M39/24—Check- or non-return valves
  • A61M2039/2426—Slit valve
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/22—Valves or arrangement of valves
  • A61M39/24—Check- or non-return valves
  • A61M2039/2473—Valve comprising a non-deformable, movable element, e.g. ball-valve, valve with movable stopper or reciprocating element
  • A61M2039/248—Ball-valve
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/33—Controlling, regulating or measuring
  • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
  • A61M2205/3386—Low level detectors
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
  • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
  • A61M2205/584—Means for facilitating use, e.g. by people with impaired vision by visual feedback having a color code

Definitions

• Inhalation devices are devices capable of delivering aerosols to the body via the lungs.
• An aerosol is a dispersion of small solid particles or fine liquid droplets in a continuous gas phase. Aerosols of liquid formulations containing a bioactive agent or drug are required for numerous medical applications, such as the inhalative treatment of asthma, cystic fibrosis (CF), and a number of other respiratory diseases.
• inhalation devices may also be used for the inhalative administration of prophylactic or diagnostic formula- tions.
• the inhalation can either be through the mouth (oral inhalation) or through the nose (nasal inhalation); both routes requiring specifically shaped patient interfaces, such as mouthpieces, to reduce aerosol losses to ambient air. More common, especially when targeting the central and/or peripheral airways of the lungs, is oral inhalation.
• the administered aerosol reaches even the smallest branches of the peripheral lungs, such as bronchioles and alveoli to ensure optimal absorption.
• liquid formulations are typically atomized by the inhalation device.
• the formed droplets may solidify to minute powder particles upon evaporation of the liquid carrier, once the aerosol cloud is expelled from the inhalation device.
• Typical inhalation devices include dry powder inhalers (DPI), pressurized metered dose inhalers (pMDI), soft mist inhalers or Rayleigh spray inhalers (such as Respimat ® inhaler, Medspray ® ) and nebulizers (such as ultrasonic nebulizers, jet nebulizers or vibrating mesh nebulizers).
• DPI dry powder inhalers
• pMDI pressurized metered dose inhalers
• soft mist inhalers or Rayleigh spray inhalers such as Respimat ® inhaler, Medspray ®
• nebulizers such as ultrasonic nebulizers, jet nebulizers or vibrating mesh nebulizers.
• Nebulizes are inhalation devices capable of converting a liquid into an inhalable aerosol in a continuous manner using a nebulizing means (or atomizing means, or aerosol generator), for example a piezo-electrically driven vibrating mesh assembly.
• a nebulizing means or atomizing means, or aerosol generator
• pMDIs and soft mist inhalers which emit metered aerosols only upon actuation and within a very short time frame of few milliseconds
• nebulizers operate continuously over the course of a few breaths up to about 45 min (or even longer if the patient requires breaks during an inhalation treatment).
• Nebulizers further differ from the afore mentioned inhalation devices (DPIs, pMDIs and soft mist inhalers) in that they do not per se emit metered amounts of aerosols, because they operate continuously, unless switched off, until the reservoir for the liquid formulation is empty.
• nebulizer is capable of ensuring that only the prescribed amount of liquid is delivered in aerosol form.
• a dosing system for such purpose is shown in EP 1 465 692 Bl which discloses a nebulizer including nebulization device and a reservoir which has a metering chamber and a second chamber.
• the metering chamber defines the volume of the substance to be nebulized and is arranged so as to feed said volume to the nebulization device, while any substance poured into the metering chamber in excess of its volume is received and retained in the second chamber.
• the metering chamber is filled until the liquid overflows into the second chamber, and only the metered volume inside the metering chamber is subsequently nebulized.
• This approach is also not very flexible.
• dosing reproducibility may be negatively affected e.g. if the user does not keep the device in a horizontal orientation during filling or use.
• any changes in the prescribed dose would require substantial modification of the device and a complete replacement of the metering chamber assembly.
• the metering system is not suitable for metering very small amounts of liquids which are substantially affected by adhesive and cohesive forces and do not easily flow from one chamber to another.
• GB 2 272 389 A discloses another dosing system which is equipped with a manually actuated, syringe-type metering pump comprising a cylinder of defined inner volume and a movable piston.
• a manually actuated, syringe-type metering pump comprising a cylinder of defined inner volume and a movable piston.
• liquid from a larger liquid supply tank is filled into the cylinder via an inlet valve.
• a droplet of liquid e.g. 20 ⁇
• An actual metering step occurs only with complete in/out strokes of the piston, making the system inflexible to the dosed volume. Further, due to the manual operation mode the system may fail to provide dosing ac- curacy and reproducibility.
• Another object is to provide a dosing system which is easy for the user to assemble and/or use and which has limited (losable) components.
• a further object is to provide a dosing system with high dosing accuracy even for small volumes.
• the invention provides the dosing system according to claims 1 and 13, an inhalation device with said dosing system and a method of dosing according to claim 15, meeting one or more of the objectives.
• Advantageous embodiments are provided in the dependent claims.
• the invention provides a dosing system for an inhalation device, comprising
• a filling chamber for receiving a liquid to be aerosolized, the filling chamber having a lateral wall, an inlet opening and an outlet opening with a closing means for closing the outlet opening;
• the inhalation device may be, or comprise, a nebulizer selected from a vibrating mesh nebulizer, a jet nebulizer, an ultrasonic nebulizer or a Rayleigh spray nebulizer, preferably a vibrating mesh nebulizer.
• the nebulizer is selected from a jet nebulizer, an ultrasonic nebulizer and a vibrating mesh nbebulizer.
• the mesh of the vibrating mesh nebulizer may be positioned below the outlet opening, and it may have a horizontal orientation while the inhalation device is held in the operating orientation.
• the inlet opening may be located at the upper end of the filling chamber.
• the outlet opening may be located at the lower end of the filling chamber, and may be closable by means of a capillary tube, a liquid flow resistor, a nozzle, a valve, a one-way valve, a duckbill valve, a slit valve or a ball valve.
• the filling chamber, or the portion of the filling chamber into which the plunger or the insertable portion of the plunger (4) is inserted; and/or the plunger, or the portion of the plunger which is inserted into the filling chamber, may be substantially cylindrical and/or may be of a flexible material.
• the filling chamber may be closable prior to and during operation of the inhalation device.
• the plunger which may be connectable to, or an integral part, of a lid, may be sized and shaped such as to be capable of closing the filling chamber.
• the lid may be a flip-top lid.
• the plunger may be connectable to, or be an integral part of, a lid wherein said lid is capable of closing the filling chamber.
• the plunger may be at least partially inserted into the filling chamber when closing the lid, thereby pushing a metered volume of liquid - which is smaller than the fill volume - out from the filling chamber through the outlet opening and into the nebulizer and/or onto the nebulizing means. During this at least partial insertion into the filling chamber, the plunger may seal the filling chamber towards the inlet opening such that no liquid leaves the filling chamber through the inlet opening.
• the outlet opening of the dosing system may further be surrounded by a residual pocket which is positioned below the outlet opening and into which the plunger cannot be inserted.
• the dosing system further comprises an outer wall of the overflow chamber, both walls having a respective upper end.
• a bulge may be formed at the upper end of the lateral wall and/or at the upper end the outer wall of the overflow chamber.
• the lateral wall has an outer side and the outer wall has an inner side, both facing the overflow chamber. The outer side and/or the inner side may be concavely curved or leaning towards the overflow chamber (5).
• the invention further comprises a dosing system for an inhalation device, comprising
• a filling chamber for receiving a liquid to be aerosolized formed by the nebulizer chamber (7) and the aerosol head component (14), the filling chamber having a lateral wall, an inlet opening and an outlet opening and a mesh (8) affixed to the outlet opening (3);
• a plunger which is at least partially insertable into the filling chamber, and which sealingly contacts the lateral wall of the filling chamber upon being at least partially inserted into the filling chamber after the filling chamber has received at least a predefined fill volume of the liquid such as to isolate a metered volume of the liquid; wherein the metered volume is smaller than the fill volume.
• the invention further provides an inhalation device with the dosing system described above.
• the invention further provides a method for dosing a liquid to be aerosolized comprising the steps of:
• a filling chamber for receiving a liquid to be aerosolized, the filling chamber having (a) a lateral wall, (b) an inlet opening and (c) an outlet opening with a closing means for closing the outlet opening ;
• the "predefined fill volume” is the minimum volume which must be filled into the filling chamber in order to achieve reproducible dosing.
• the volume of liquid actually filled into the filling chamber may be slightly or even substantially larger than the predefined fill volume, or minimum fill volume.
• the liquid can be provided, for instance, in pre-filled single-use containers, such as vials, or ampoules, as commonly available for many commercialized inhalative medications.
• the fill volume may vary between containers, and the volume withdrawn from a container may also depend on the user.
• the invention provides a means for delivering a prescribed dose of inhalation liquid in aerosol form in spite of these variations.
• the "metered volume”, as used herein, is the predefined volume of liquid which the dosing system feeds to the aerosol generator, and which is converted into an aerosol delivered to the user.
• the metered volume is a part of the fill volume.
• An “aerosol generator” is a device or device component capable of generating an aerosol.
• a “nebulizing means” is an aerosol generator which generates an aerosol from a liq- uid.
• the aerosol comprises a liquid phase consisting of small, typically inhalable droplets dispersed in a gas phase such as air.
• overflow chamber refers to a chamber associated with the dosing system or parts thereof, which takes up a fraction of any volume in excess to the metered volume, irrespective of whether this fraction is spontaneously (over)flowing due to gravity or whether it is actively transferred during operation of the dosing system; e.g. by displacement.
• a “nebulizer” may refer to a nebulizing means to an inhalation device comprising a nebulization means, depending on the context.
• Figure 1 shows a prior art dosing system for a nebulizer as disclosed in
• Figures 2A-C show a dosing system according to an embodiment of the invention
• Figures 3 A-B show a duckbill valve for a dosing system according to an embodiment of the invention, provided as a separate part (B] or as an integral part (A) of the filling chamber's outlet opening (3)
• Figure 4 shows a dosing system according to an embodiment of the invention in open state with the fill component folded down
• Figure 5 shows an exploded view of the hinged components of a dosing system according to an embodiment of the invention
• Figures 6A-B show a dosing system according to an embodiment of the invention in open state (A] and in closed state (B); dashed lines represent exemplary liquid levels
• Figures 7A-C show a dosing system according to an embodiment of the invention in open state (A), upon insertion of the plunger (B] and in closed state (C]
• Figures 8A-B show a dosing system according to an embodiment of the invention in open state (A) and in closed state (B)
• Figure 9 shows a simplified display of a dosing system according to an embodiment of the invention
• the dashed line marks the fill level of e.g. 1 ml poured in the fill chamber
• the dotted area represents the volume to be dosed
• Figures 10A-B show a dosing system according to an embodiment of the invention in open state [A] and in closed state (B); dashed lines represent exemplary liquid levels
• Figures 11A-B show a dosing system according to an embodiment of the invention in open state (A) and in closed state (B); dashed lines represent liquid levels
• Figures 13A-E show a dosing system according to an embodiment of the invention in different steps of the filling procedure (A-C), in open state (D) and in closed state (E); dashed lines represent liquid levels
• Aerosol head component 38 One-way-valve
• the invention provides a dosing system for an inhalation device, comprising
• a filling chamber for receiving a liquid to be aerosolized, the filling chamber having a lateral wall, an inlet opening and an outlet opening with a closing means for closing the outlet opening;
• a plunger which is at least partially insertable into the filling chamber, and which sealingly contacts the lateral wall while being at least partially inserted into the filling chamber such as to push, after the filling chamber has received at least a predefined fill volume of the liquid, a metered volume of the liquid out from the filling chamber through the outlet opening, wherein the metered volume is smaller than the fill volume.
• the volume which is displaceable by the plunger, or the volume of the plunger which is insertable into the filling chamber is smaller than the predefined fill volume.
• the inhalation device is, or comprises, a nebulizer selected from ultrasonic nebulizers, jet nebulizers or vibrating mesh nebulizers.
• a nebulizer selected from ultrasonic nebulizers, jet nebulizers or vibrating mesh nebulizers.
• the nebulizer is a vibrating mesh nebulizer.
• the dosing system has an operating orientation, and the filling chamber of the dosing system has an upper end and a lower end.
• the inlet opening when in operating orientation, is located at the upper end of the filling chamber and the outlet opening is located at its lower end.
• the liquid to be aerosolized may flow from the inlet opening towards the outlet opening when the filling chamber is filled.
• the outlet opening of the dosing system is closable by means of a capillary tube, a liquid flow resistor, a nozzle, a valve, a one-way valve, a duckbill valve, a slit valve or a ball valve.
• the outlet opening of the dosing system is in fluid connection with an aerosol generator; i.e. the outlet opening is not closed by a closing means but instead is located at a higher level than the inlet opening when in operating orientation.
• the mesh of the vibrating mesh nebulizer may be positioned below the outlet opening and may have a horizontal orientation when in operating orientation.
• the filling chamber has a portion into which the plunger or an insertable portion of the plunger (4) is inserted.
• the plunger is inserted, or has a portion which is inserted, into the filling chamber.
• the filling chamber, or the portion of the filling chamber into which the plunger or the insertable portion of the plunger is inserted, and/or the plunger, or the portion of the plunger that is inserted into the filling chamber may be somewhat cylindrical in overall shape, or even substantially cylindrical.
• the cylindrical filling chamber may have a vertical, or approximately vertical orientation under operating conditions.
• the filling chamber, or the portion of the filling chamber into which the plunger or the insertable portion of the plunger is inserted; and/or the plunger, or the insertable portion of the plunger may also have quite different shapes; e.g. polygonal or "doughnut-shaped" with the plunger being the convex part and the filling chamber being the concave counterpart.
• the volume dis- placeable by the plunger, or the volume of the plunger insertable into the filling chamber is always smaller than the predefined fill volume.
• the filling chamber, or the portion of the filling chamber into which the plunger or the insertable portion of the plunger is inserted; and/or the plunger, or the insertable portion of the plunger may be made of a flexible material.
• a flexible plunger may be combined with a rigid filling chamber, or a rigid plunger may be combined with a flexible filling chamber.
• the filling chamber is closable prior to and during the operation of the inhalation device; i.e. before and during the onset of nebulization.
• the dosing system comprises a lid and the plunger is connecta- ble to, or an integral part, of the lid, and may be sized and shaped such as to be capable of closing the filling chamber such as to be capable of closing the filling chamber.
• the plunger is connectable to, or an integral part of, the lid and the lid is capable of closing the filling chamber.
• the plunger is at least partially inserted into the filling chamber when the lid is closed.
• the lid is a flip-top lid; preferably a lid attached with an off-centered hinge.
• the plunger seals the filling chamber towards the inlet opening during its at least partial insertion into the filling chamber, such that no liquid leaves the filling chamber through the inlet opening.
• the outlet opening is surrounded by a residual pocket which is positioned at a lower level than the outlet opening and into which the plunger cannot be inserted.
• such residual pocket is divided into a plurality of compartments.
• the dosing system further comprises an outer wall of the overflow chamber; each having a respective upper end.
• a bulge or rim is formed at the upper end of the lateral wall of the filling chamber and/or at the upper end of the outer wall of the dosing system.
• the lateral wall of the filling chamber has an outer side facing the overflow chamber and the outer wall of the overflow chamber has an inner side facing the overflow chamber.
• One or both sides may be concavely curved or leaning towards the overflow chamber.
• the invention further comprises a dosing system for an inhalation device, comprising
• a filling chamber for receiving a liquid to be aerosolized formed by the nebulizer chamber (7) and the aerosol head component (14), the filling chamber having a lateral wall, an inlet opening, an outlet opening and a mesh affixed to the outlet opening;
• a plunger which is at least partially insertable into the filling chamber, and which sealingly contacts the lateral wall of the filling chamber upon being at least partially inserted into the filling chamber after the filling chamber has received at least a predefined fill volume of the liquid such as to isolate a metered volume of the liquid; wherein the metered volume is smaller than the fill volume.
• the here invented device reduces the influence of liquid properties to a minimum.
• the actually metered volume is controlled by the well-defined displacement, or pumping effect, of the plunger, in combination with the well-defined opening pressures of the valve (s).
• any excess volumes of liquid which are not supposed to be administered to the user are isolated in a separate overflow chamber and cannot be re-dosed accidentally, which increases the operational safety of the dosing device.
• the invention further provides an inhalation device with the dosing system according to the invention.
• the invention further provides a method for dosing a liquid to be aerosolized com- prising the steps of:
• a filling chamber (1) for receiving a liquid to be aerosolized, the filling chamber having (a) a lateral wall, (b) an inlet opening and (c) an outlet opening with a closing means for closing the outlet opening
• Figures 2A-C show a dosing system according to a specific embodiment of the invention, comprising
• a substantially cylindrical filling chamber (1) for receiving a liquid to be aerosolized the filling chamber having a substantially circular inlet opening (2) and a substantially circular outlet opening (3) which is closed by a duckbill valve (11) such as to prevent the liquid received by the filling chamber (1) from flowing through the outlet opening (3) by gravity;
• a substantially cylindrical plunger (4) which is at least partially insertable into the filling chamber (1), and which sealingly contacts the lateral wall (42) while being at least partially inserted into the filling chamber (1) such as to push, after the filling chamber (1) has received at least a pre-defined fill volume of the liquid, a metered volume of the liquid out from the filling chamber (1) through the outlet opening's duckbill valve (11), wherein the metered volume is smaller than the fill volume.
• the cylindrical shape chosen in this particular embodiment allows for an easier insertion of the plunger (4), especially since in this embodiment the plunger (4) is initially inserted into the filling chamber (1) at a slight angle to the filling chamber's longitudinal axis, as can be seen in figure 2B.
• the plunger (4) is an integral part of a lid (9) which is fixed with a hinge (10) at an off-centered position.
• the filling chamber (1) is accommodated within a housing (15) affixed to the same hinge (10).
• An exploded view of a lid assembly with a hinge is depicted in figure 5.
• Such flip-top lid assemblies are preferred for the present invention from a user's perspective, since they reduce the number of components which may be lost and/or assembled incorrectly.
• the filling chamber (1) is closable prior to and during operation of the inhalation device. More specifically, the plunger (4) is at least partially inserted into the filling chamber (1) when closing the lid. During its insertion, the plunger (4) seals the filling chamber (1) towards the inlet opening (2) such that no liquid leaves the filling chamber (1) through the inlet opening (2). This is achieved by the plunger (4) being sized and shaped such as to be capable of closing the filling chamber.
• the plunger (4) in this specific embodiment matches the size and shape of the inlet opening (2) of the filling chamber (1) (both being cylindrical, the outer diameter of the plunger (4) corresponding to the inner diameter of the filling chamber (1) and the length of the plunger (4) being similar to, or slightly shorter than, the height of the filling chamber (1)), the plunger (4) itself closes and seals the inlet opening (2) during its insertion into the filling chamber (1).
• the contact between the plunger (4) and the filling cham- ber's lateral wall (42) at the inlet opening (2) is further enhanced by the fact that the filling chamber's lateral wall (42) is made of a flexible material and tilts slightly towards the plunger (4), as also shown in the enlarged views in figures 3A and B.
• This is advantageous because no further sealing means are required; such as the additional O-ring seals around the plunger (4) used in some of the prior art.
• this allows the plunger (4) to slide smoothly into the filling chamber (1) and avoids undesirable friction below the inlet open- ing (2).
• the plunger (4) is sized and shaped such as to match the size and shape of the inlet opening (2) in order to allow the plunger (4) to reproducibly displace liquid and push it through the outlet opening (3).
• the plunger (4) could have the same shape and a precisely fitting diameter, but may have a length shorter than that of the filling chamber; or the plunger may have the same shape and a precisely fitting diameter only at the plunger's tip (the plunger part which is inserted into the filling chamber first) while the rest of the plunger may have a different shape and diameter.
• the plunger may not even have to close and seal the complete inlet opening (2) in order to displace the metered volume from the filling chamber (1).
• hard and/or inflexible materials are polyoxymethylene (POM; also known as acetal, polyacetal or polyformaldehyde) or polypropylene (PP), polyether-ether-ketone (PEEK) and polyamide (PA).
• POM polyoxymethylene
• PP polypropylene
• PEEK polyether-ether-ketone
• PA polyamide
• An overflow chamber (5) surrounds the inlet opening (2) of the filling chamber (1), e.g. circimferentially, in order to receive any excess volume of liquid which cannot be contained within the filling chamber (1).
• This offers the important advantage that the excess volume in the overflow chamber (5) is prevented from unintentionally flowing back into the filling chamber (1) upon withdrawal of the plunger (4) from the filling chamber (1) after the dosing step; i.e. after the step of closing the lid (9) and thereby moving the plunger
• a bulge (44), such as a rim, may be formed at the upper end of the lateral wall (42) and/or at the upper end of the outer wall (45) of the overflow chamber.
• the bulge (44) may be leaning towards the overflow chamber (5) and away from the filling chamber (1).
• Such a bulge (44) at the upper end of the lateral wall (42) can be seen exem- plarily in figures 2A to 4, in particular in the enlarged views of figures 3A and B.
• the outer side (46) of the lateral wall (42) facing the overflow chamber (5) and/or the inner side (47) of the outer wall (45) facing the overflow chamber (5) may be concavely curved or leaning towards the overflow chamber (5).
• the bulge (44) and/or the orientation and shape of the outer and inner sides (46 and 47) facing the overflow chamber (5) reduce the risk of unintended re-dosing even further, because even if the device is tilted a bit by the user, or moderately moved out of the operating orientation, the excess volume of liquid contained in the overflow chamber
• a volume of liquid to be nebulized is filled into the filling chamber (1).
• the actual fill volume matches or exceeds the minimal fill volume, also referred to as pre-defined fill volume.
• the liquid may be withdrawn from single- use container as available for many commercialized inhalative medications.
• the inhalation device is best placed on an even surface, the lid (9) opened wide with the housing (15) resting on the aerosol head component (14). Then the pre-filled fill volume can be poured easily through the wide top opening of the housing (15) and through the inlet opening (2) into the filling chamber (1). If more liquid is filled into the device than can be held by the filling chamber (1), some of the liquid may flow into an overflow cham- ber (5).
• the pre-defined (or minimum) fill volume is at least slightly larger than the metered volume.
• the overflow chamber (5) surrounds the inlet opening (2) of the filling chamber (1) and/or the filling chamber (1) circumferentially.
• the plunger (4) is inserted into the filling chamber (1) by clos- ing the filling chamber (1) with the hinged lid (9), thereby displacing a part of the liquid in the filling chamber (1), which is pushed out through the duckbill-valve (11) of the outlet opening (3).
• the plunger (4) is not inserted, or insertable, into the overflow chamber (5).
• the plunger (4) may be directly immersed into the liquid filled into the filling chamber (1).
• the dosing system may also be configured such that plunger (4) is not immersed into the liquid upon its insertion into the filling chamber (1).
• the metered volume of liquid is indirectly displaced by the plunger (4) via entrapped air.
• the outlet opening (3) is in fluid connection with the nebulizing means (6), or aero- sol generator.
• the metered volume of liquid which is pushed through the outlet opening (3) will flow freely into the nebulizing means (6); more specifically into the nebulizing means' (6) internal cavity, herein also called the nebulizer chamber (7).
• the outlet opening is closable by means of a capillary tube, a liquid flow resistor, a nozzle, a valve, a one-way valve, a slit valve, a ball valve, or a duckbill valve (11) as shown in figures 2A-C, at least to the extent as to prevent the liquid received by the filling chamber from flowing through the outlet opening by gravity.
• the embodiment in figures 2A-C shows a vibrating mesh nebulizer as the nebulizing means (6).
• An exemplary nebulizing means according to this invention is described e.g. in EP 2 091 663 Bl.
• the mesh (8) of the vibrating mesh nebulizer is positioned below the outlet opening (3) and has a horizontal orientation while the inhalation device is held in the operating orientation.
• the nebulizing means (6) comprises an internal cavity for containing the liquid to be aerosolized, the nebulizer chamber (7).
• the volume of the nebulizer chamber (7) is larger than the target volume to be metered so that the metered volume can be accommodated completely within the nebulizer chamber (7).
• the liquid is held in the nebulizer chamber (7) by the horizontally arranged mesh (8) until the onset of operation of the vibrating mesh nebulizer. Then the mesh (8) will be vibrated, e.g. by a piezo-electric ceramic element, and the liquid will gradually be passed through the mesh (8) in the form of minute droplets.
• a small opening for venting (not shown in figures 2 A-C) in the lateral wall of the nebulizing means (6) to avoid the build-up of any under- pressure when the liquid in the nebulizer chamber (7) is gradually removed by nebuliza- tion through the mesh (8).
• such an opening should be positioned slightly below the outlet opening (3), but above the uppermost level of the liquid column resting in the nebulizer chamber (7), such that none of the metered volume is lost through said venting opening.
• this opening may also be provided with a one-way valve to prevent any loss of the metered volume of liquid even if the user tilts the inhalation device.
• the volume of liquid pushed through the outlet opening (3) is metered by displacement, i.e. by the volume of the plunger (4), or the respective portion of the plunger (4), which is inserted into the filling chamber (1). Therefore, only small changes in the geometry of the plunger, such as the length of the plunger, are required to adjust the metered vol- ume to a different target volume, thus providing a major advantage over prior art systems. For instance, different plungers could be provided for the different doses required for adults, kids and infants or to account for dose adaptations that can become necessary when the condition of a patient changes. Moreover, a plunger with a variable insertion depth may be used, and the insertion depth may be adjusted e.g. by a wheel.
• a color-coding system and/or an embossed letter at the top of the plunger may optionally be used to allow for a clear and easy distinction between different plungers.
• a plunger (4) which is connectable to the lid (9) may be more advantageous, because it could be exchanged more easily and/or with less material consumption than exchanging the whole lid (9).
• small exchangeable components such as the plunger (4) may easily get lost when not connected to the lid; e.g. the may fall into the sink during the cleaning of the dosing system. They may also be harder to handle for elderly and kids. Thus, both options should be considered with care and with regard to the potential user.
• Figure 2C shows the plunger (4) after its complete insertion, i.e. when the lid (9) is fully closed and shut by a snap-fit-lock (13).
• a re- sidual pocket (12) surrounds the outlet opening (3), from which liquid cannot be pushed out while the plunger (4) is at least partially inserted into the filling chamber (1). This is because the residual pocket is positioned at a lower level than the outlet opening (3) and further because the plunger cannot be inserted into the residual pocket even when the plunger reaches its final position in the filling chamber.
• Such a residual pocket (12) can be used to increase the tolerance of the dosing system to variable fill volumes of liquid filled into the filling chamber (1), in particular for small metered volumes, and may reduce the need for large overflow chambers (5).
• An enlarged view of the outlet opening (3), duckbill valve (11) and the residual pocket (12) can also be seen in figures 3A and B.
• the residual pocket (12) should preferably be positioned and shaped such as to minimize the risk of accidental re-dosing, e.g. by opening and closing the lid (9) after nebu- lization without first emptying and cleaning the device. Unintended opening and closing of the lid (9) after the dosing step is also impeded by the snap-fit lock (13).
• the duckbill valve (11), or any other means for closing the outlet opening (3) at least to the extent as to prevent the liquid received by the filling chamber (1) from flowing through the outlet opening (3) by gravity, such as a capillary tube, liquid flow resistor, nozzle, valve, one-way valve, duckbill valve, slit valve or ball valve, may be formed as an inte- gral part of the filling chamber's outlet opening (3) as shown in figure 3A, or alternatively as a separated part which is attached, insertable and/or connectable to the dosing system's filling chamber and/or outlet opening; e.g. by a snap-fit mechanism, as shown in figure 3B.
• FIG 4 An alternative embodiment of a dosing system provided with a slit valve (22) - instead of a duckbill valve (11) - closing the outlet opening (3) is shown in figure 4, with the dashed lines representing the fill level in the filling chamber (1) and an exemplary fill level in the overflow chamber (5).
• Exemplary slit valves are single slit or cross slit valves.
• An exploded view of the hinged components of the dosing systems depicted in figures 2A-C or 4 is depicted in figure 5. Hinged flip-top lids advantageously allow for simple yet reproducible closing, opening, and cleaning, while at the same time reducing the risks of incorrect assembly and/or loss of any loose parts.
• the assembly shown in figure 5 comprises a lid (9) with the plunger (not shown), a housing (15) for the filling chamber (1), a fixture (16) and an aerosol head component (14).
• the aerosol head component (14) comprises, or is connected to, the nebulizing means (6) (not shown), a central opening (18) to allow for fluid connection between the dosing system's outlet opening (3) and the nebulizer chamber (7) and one part of the snap-fit lock (13) which secures the lid (9) upon closure.
• An exemplary aerosol head component (14) with a nebulizing means (6) is described e.g. in EP application no. 12190139.1.
• the housing (15) comprises the filling chamber (1) with its inlet- and outlet openings (2, 3) and the overflow chamber (5), and has an annular groove (17) around its circumference.
• the annular groove (17) allows for the correct and secure placement of the housing (15) in the fixture (16) via a snap-fit.
• this fixture (16) comprises a part which upon assembly and connection with a bolt (not shown) forms a sturdy hinge (10).
• One of the purposes of providing a housing (15) with a separate fixture (16) is to allow an easy exchange of the housing (15) without the need to unhinge all components.
• the hinge (10) can be configured with different latching positions so as to allow the user to more easily space apart the lid (9), the housing (15) in its fixture (16) and the aerosol head component (14), without the need to hold them apart manually. This is particularly useful e.g. when cleaning the device with water after the inhalation.
• latching positions can be applied to prevent the housing (15) in its fixture (16) from being flipped off from the aerosol head component (14) at angles of more than e.g. 45-55°.
• the housing (15) "shields" the opening of the nebulizer chamber (7) and thereby guides the user not to fill the nebulizer chamber (7) rather than the housing (15).
• the embodiment depicted in figures 6A-B is particularly suitable for relatively large fill volumes from which only a relatively small portion is metered and fed to the nebulizing means.
• the dashed line indicates an exemplary liquid level after filling the filling chamber (1).
• the overflow chamber (5) may optionally surround the inlet opening (2) of the filling chamber (1) and/or the filling chamber (1) itself circumferentially.
• the lateral wall of the filling chamber (1) widens towards the inlet opening such as to prevent the user from accidentally filling liquid into the overflow chamber (5), which decreases the risk for potential dosing inaccuracies.
• One or more outlets are provided in the lateral wall of the filling chamber (1). Their function is to allow liquid to flow, or be pushed, from the filling chamber (1) into the overflow chamber (5) until a predefined liquid level in the filling chamber (1) is reached. Typically, this pre-defined liquid level is similar to, or the same as, the pre-defined fill volume.
• the flow of liquid into the overflow chamber (5) requires some pres- sure, e.g. as exerted during the initial phase of the insertion of the plunger (4) into the filling chamber (1).
• the one-way valve (s) (19) also prevent(s) liquid from flowing back from the overflow chamber (4) into the filling chamber (1), thus further reducing the risk of dosing inaccuracy.
• the resistance of the one-way valves (19) is lower than that of the duck-bill valve (11). Further inserting the plunger (4), i.e. beyond the level of the lateral one-way valve (s) (19), causes the displacement of the metered volume of liquid which is pushed from the filling chamber (1) through the outlet opening (3) via the duck-bill valve (11).
• Figure 6B shows the plunger (4) after its completed insertion, i.e. when the lid (9) is fully closed and shut by the snap-fit lock (13).
• the length of the plunger (4) is the maximum length in combination with the filling chamber (1) reaching down all the way to the outlet opening (3), so that almost all of the liquid in the filling chamber (1) which was not pushed through the low resistance one-way valve(s) (19) is displaced and pushed out through the duckbill valve (11).
• the plunger (4) can have various lengths, shapes and/or volumes to allow for dosing flexibility.
• the metered volume may be a relatively small or a relatively large portion of the fill volume.
• the lid (9) is capable of closing the filling chamber (1), not the plunger (4) itself; e.g. if a cylindrical plunger has a smaller diameter than the respective cylindrical filling chamber so that no seal would be formed between plunger and the filling chamber walls.
• the plunger (4) may be either an integral part of the lid (9) or it may be connectable to it. If the plunger (4) is connectable to the lid (9), the connection between lid (9) and plunger (4) may be designed to allow an easy exchange of the plunger (4) (e.g. when the dose required by the patient changes), while at the same time being sturdy enough to prevent unintentional loss of the plunger, e.g. during the cleaning routine. In analogy, if the plunger is an integral part of the lid, the connection between lid (9) and hinge (10) may be designed to allow an easy exchange of the lid, while at the same time being sturdy enough to prevent unintentional loss of the lid.
• the lid (9) of the dosing system may be e.g. a hinged flip-top lid, a screw-on lid or a snap-on lid.
• the lid is provided with a sealing lip.
• Figures 6C shows a further embodiment with a screw-on lid, together with a funnel- shaped filling chamber (1), and a specifically shaped aerosol head component (14) which houses the overflow chamber (5).
• the dosing funnel (20) is placed into the aerosol head component (14) and the fill volume is poured into the cylindrical filling chamber (1) through the wide inlet opening (2).
• Overflow slits (21) are provided along the perimeter of the dosing funnel (20).
• the bottom end of the plunger (4) Upon insertion of the cylindrical plunger (4) into the cylindrical part of the filling chamber (1), using the screw-on lid (9), the bottom end of the plunger (4) first forms a seal with the lateral wall (42) of the filling chamber (1) and starts to displace a metered volume of liquid, pushing it through the duckbill valve (11) of the outlet opening (3) into the nebulizer chamber (7). Due to the specific shape of the filling chamber (1), the risk of entrapping air in it upon insertion of the plunger (4) is greatly reduced.
• the wider base of the plunger (4) forms a second seal with the lateral wall of the widened portion of the dosing funnel (20) at or near the inlet opening (2), just above the overflow slits (21), and depending on the fill volume pushes excess liquid through the overflow slits (21) into the overflow chamber (5), as indicated by the black arrows.
• the residual volume of non-metered liquid remaining in the filling chamber (1) after complete insertion of the plunger (4), as depicted in figure 7C, will again depend on the chosen dimensions and the volume of the plunger (4).
• the funnel-shaped filling chamber (1) is attached to the aerosol head component (14) in order to not be lost or misplaced, e.g. by a flexible strap.
• the funnel-shaped filling chamber (1) and the aerosol head component (14) are configured in such a way that the lid (9) can only be closed if the filling chamber (1) is positioned correctly, e.g. the thread of the screw-on lid catches only in a respective counter thread formed by the aerosol head component (14) and the correctly positioned filling chamber (1) together.
• inlet opening (2) and the outlet opening (3) of the filling chamber (1) are typically separate, with the outlet opening (3) typically being positioned below the inlet opening (2) when in operational orientation, there may also be embodiments wherein the two openings are the same and/or wherein alternatively one opening includes the other.
• Figures 8A and B show an embodiment of the invention wherein the inlet opening (2) comprises the outlet opening (3) in such a way that the outlet opening (3) is radially surrounded by the inlet opening (2). It also represents an embodiment wherein the plung- er (4) and the filling chamber (1) are not cylindrical but configured as matching ring- shaped forms; the plunger being the convex part (or curving out, or bulging outward, or protruding, or positive) and the filling chamber being the respective concave counter-part (or curving in, or bulging inwards, or negative).
• the user Prior to use of the inhalation device, the user would pour the pre-defined fill volume into the filling chamber (1), i.e. the inner of the two ring segments. Pouring liquid into the outlet opening (3) and thus the nebulizer chamber (7) should be avoided.
• a filling aid may be provided which covers the outlet opening (3) and guides the pre-defined fill volume into the two outer ring segments filling chamber (1) and which is then removed before mounting the screw-on lid (9). Depending on the volume of liquid filled into the de- vice, some excess liquid may flow into the overflow chamber (5), i.e. the outer of the two ring segments.
• the outlet opening (3) in this embodiment is positioned above the maximum fill level of the filling chamber (1), no closing means are required to avoid filled liquid flowing out the outlet opening (3) by gravity. Only upon insertion of the plunger (4), a seal is formed (see seal 3 in figure 8B) between the lateral walls of the filling chamber (1) and the bottom end of the plunger (4), such that liquid displaced in the filling chamber (1) is pushed upwards. In effect, the metered volume flows into the nebulizer chamber (7).
• the embodiment depicted in figure 8 further exhibits a safety plunger (26), which is does not determine the metered volume.
• FIG. 9 shows a simplified display of an alternative dosing system according to the invention without overflow chamber, but with a large residual space for excess liquid which is not to be nebulized.
• the system has a filling chamber (1) with an inlet opening (2) and a vertical pipe (24) positioned, approximately centered, at the bottom of the filling chamber (1).
• the vertical pipe may function as a capillary tube which closes the outlet opening (3) and keeps the liquid from flowing out of the filling chamber (1) by gravity.
• the pipe (24) may be wider and provided with a closing means, such as a duckbill valve (11) a liquid flow resistor, a nozzle, a valve, a one-way valve, a slit valve, a ball valve or the like.
• a closing means such as a duckbill valve (11) a liquid flow resistor, a nozzle, a valve, a one-way valve, a slit valve, a ball valve or the like.
• the fill volume Prior to use of the inhalation device, the fill volume is poured into the filling cham- ber (1); an exemplary fill level being indicated by the dashed line in figure 9.
• the excess liquid above a sealing edge (25) is first displaced and rises around the plunger (4).
• the wall of the filling chamber (1) is shaped to accommodate this rising liquid level without any spills, even when the filling chamber (1) is slightly overfilled and/or if the user tilts the device slightly out of the operational orientation.
• FIG. 10A and B show an embodiment wherein the filling chamber (1) is housed in the screw-on lid (9), as a part of a separation chamber (28).
• the separation chamber (28) mainly comprises a flexible funnel-shaped filling chamber (1), e.g.
• the widened upper section (29) of the filling chamber (1) is attached to a sealing lip (31) of the lid (9) via several (e.g. 3 to 8) thin, rigid funnel ribs (30) spaced around the upper perimeter of the filling chamber (1).
• the funnel ribs are tilted sideways in such a way that the perimeter of the upper section (29) is held locked against the lid's sturdy central cylinder (34). This is to ensure that filled liquid does not spill from the filling chamber (1) during minor handling errors such as slight tilting of the dosing system.
• the lid (9) Prior to use of the inhalation device, the lid (9) is positioned on the aerosol head component (14), but not screwed on yet, and the liquid is poured into the filling chamber (1) by inserting an opened cartridge, or vial, or ampoule (27) with the open end first into the lid's (9) cartridge port (32).
• a puncture pin (33) extending from the lid (9) causes the disruption of any surface tension of the liquid in the cartridge (27), such that the liquid will flow out freely through the inlet opening (2) into the filling chamber (1), where it is held back by the closed slit valve (22) at the outlet opening (3).
• An exemplary fill level is indicated by the dashed line in figure 10A.
• the filling chamber (1) rests on the central cylinder (35) of the aerosol head component (14), so that when the lid (9) is screwed on, it gradually gets pressed against the plunger (4) and the lid (9).
• the plunger (4) is inserted into the filling chamber (1) and pushes the metered volume through the slit valve (22) at the outlet opening (3) into the nebulizer chamber (7).
• the funnel ribs (34) recover from their tilted positions. As they straighten up, the perimeter of the widened upper section (29) is pressed downwards, away from the central cylinder of the lid (34) until it is inverted, or folded down, as shown in figure 10B.
• this displacement into the nebulizer chamber (7) involves pushing the metered volume through a valve at the outlet open- ing (3). This means that the metered volume is actively separated from an excess by the movement of the plunger.
• the plunger in the embodiments in figures 11 to 14 does not displace, or push, the metered volume to the nebulizer chamber (7) but merely isolates it from an excess of liquid (not to be dosed) once the plunger has reached its final position.
• This approach may be understood as a kind of "reverse dosing" in that an excess is actively separated from the metered volume by the movement of the plunger, rather than vice versa.
• the metered volume is either allowed to simply flow freely, by gravity, into the nebulizer chamber (7) as depicted in figures 12A and B; or the nebulizer chamber (7) itself forms the filling chamber (la) from the metered volume may be nebulized directly, as depicted in figures 11, 13A to E and 14A and B. This is explained in more detail below and with regard to the figures.
• Figures 12A and B show another embodiment with an overflow chamber (5a) ac- commodated in the lid (9), and more specifically within a hollow plunger (4); i.e. the overflow chamber (5a) is associated with the plunger (4).
• Low resistance one-way valves (19) provided near the bottom end of the plunger (4) allow a unidirectional flow of excess liquid from the filling chamber (1) into the overflow chamber (5) under slight pressure, i.e. when the plunger (4) is at least partially inserted into the filling chamber (la).
• the plunger is fully inserted, (e.g.
• the metered volume is still controlled by the dimensions and /or insertion depth of the plunger (4) but it is transferred to the nebulizer chamber (7) by the action of the release pin (23), not by the plunger (4) pushing it out. It is actually the excess volume which is displaced here by the plunger (4), whereas the metered volume flows through the slit valve (22) when opened by the release pin (23).
• the invention further provides a dosing system for an inhalation device, comprising:
• a plunger (4) which is at least partially insertable into the filling chamber (la), and which sealingly contacts the lateral wall (42) of the filling chamber (la) upon being at least partially inserted into the filling chamber after the filling chamber has received at least a predefined fill volume of the liquid such as to isolate a metered volume of the liquid; wherein the metered volume is smaller than the fill volume.
• the inhalation device comprises a nebulizer.
• the nebu- lizer may be a vibrating mesh nebulizer.
• the essential function of the plunger (4) is to isolate the metered volume from the non-metered portion of the fill volume by forming a seal with the lateral wall (42) of the filling chamber (la) in the inserted state.
• the metered volume of liquid can then be nebulized directly or transferred to a nebulizing means (6).
• Figures 11A and B show a simplified representation of a dosing system according to this embodiment, with dashed lines representing exemplary liquid levels.
• the dosing system comprises a filling chamber (la) with a slightly tapered lateral wall (42) and an inlet opening (2) through which the fill volume is received.
• the outlet opening (3) is closed by the mesh (8) of a vibrating mesh nebulizer; i.e.
• the filling chamber (la) and the nebulizer chamber (7) are identical.
• the plunger (4) is at least partially inserted (as shown in figure 11B), causing some excess liquid to rise around the plunger (4) until the sealing surface of the plunger (4; in figure 11B the bottom end of the plunger) sealingly contacts the lateral walls (42) of the filling chamber (la), or nebulizer chamber (7).
• the metered volume is isolated below the plunger (4) and can now gradually pass through the vibrating mesh (8) in the form of an aerosol, as indicated by the dotted lines below the mesh (8).
• the simplified dosing system in figures 11A and B further comprises an overflow chamber (5), which may be associated with the plunger (4), such as the overflow chamber (5a) depicted in figures 13A to E and 14A and B.
• the inlet opening (2) when in an operating orientation, is located at an upper end of the filling chamber (la) and the outlet opening is located at its lower end, so that the liquid to be aerosolized flows freely by gravity from the inlet opening (2) towards the outlet opening (3) when the filling chamber is filled.
• the mesh (8) of the vibrating mesh nebulizer may be positioned at the outlet opening (3) and may have a horizontal orientation when in the operating mode.
• the filling chamber, or the portion of the filling chamber into which the plunger or the insertable portion of the plunger is inserted, and/or the plunger, or the portion of the plunger that is inserted into the filling chamber is somewhat cylindrical, or substantially cylindrical.
• the filling chamber, or the portion of the filling chamber into which the plunger or the insertable portion of the plunger is inserted, and/or the plunger, or the portion of the plunger which is insertable into the filling chamber may be made of a flexible material.
• the filling chamber is closable prior to and during operation of the inha- lation device.
• the plunger is sized and shaped such as to be capable of closing the filling chamber; or the plunger is connectable to, or an integral part of, a lid which is capable of closing the filling chamber.
• the plunger is at least partially inserted into the filling chamber by closing the filling chamber.
• the plunger seals the filling chamber towards the inlet opening during its at least partial insertion into the filling chamber, such that no liquid leaves the filling chamber through the inlet opening.
• a funnel-shaped filling chamber (la) is formed by the nebulizer chamber (7) and the aerosol head component (14).
• the aerosol head component (14) is further equipped with a flexible gasket component (36), made e.g. from silicone.
• the gasket component comprises a sealing lip (31), a cylindrical plunger (4) with a central channel (39), an overflow chamber (5a), a one-way valve (38) and a gasket (37).
• An opened vial (27) or other container holding a liquid may be inserted into the gasket (37) head first, i.e. upside down. Surface tension or a slight underpressure may prevent the liquid to immediately empty into the filling chamber (la).
• Exemplary liquid levels are shown as dashed lines in figure 13A.
• the central gasket opening (41) serves as the inlet opening (2) of the filling chamber (la).
• a mesh (8) is affixed to the outlet opening (3).
• the gasket (37) forms a seal around it, and the air trapped between the aerosol head component (14) and the gas- ket component (36) escapes through a one-way valve (38), e.g. a duckbill valve, as indicated by the arrow in figure 13B.
• a one-way valve e.g. a duckbill valve
• the flexible gasket component (36) flips back into its original shape (as shown in figure 13C), thereby creating an underpressure sufficient to suck out the liquid from the vial (27).
• the liquid is conducted, through the channel (39) of the plunger (4) into the filling chamber (la).
• the seal between the gasket (37) and the vial (27) opens so that air can be drawn in (as indicated by the arrows in figure 13C) and the empty vial (27) can be removed from the gasket (37).
• a lid (9) is screwed on to the aerosol head component (14), as shown in figures 13D and E.
• the lid (9) comprises a central stopper (40) that is shaped and sized such as to match the gasket (37) and close the central gasket opening (41).
• the flexible gasket component (36) and the plunger (4) attached to it are pressed down such that the gasket component (36) forms a funnel-shaped overflow chamber (5a) at the upper side of the gasket component (36), whereby air and excess liquid trapped between the aerosol head (14) and the lower side of the gasket component (36) are displaced and pushed through the one-way valve (38) into the overflow chamber (5a), as indicated by the arrow in figure 13E.
• the flow resistance of the mesh (8) is higher than that of the one-way valve (38) so that no liquid is pushed through the mesh (8) upon screwing on the lid (9).
• the gasket component (36) Upon complete closure of the lid (9), the gasket component (36) is pressed against the aerosol head component (14), with the outer zone of the gasket component (36) forming a sealing lip (31) between the lid (9) and the aerosol head component (14). Thereby, the metered volume is isolated and separated from excess liquid which is pushed through the one-way valve (38) into the overflow chamber (5a). The metered volume remains in the lower part of the filling chamber (la) which is formed by the nebulizer chamber (7), in the channel (39) in the plunger (4) and in the gap formed between the lateral wall (42) of the nebulizer chamber (7) and the plunger (4). Exemplary liquid levels are shown as dashed lines in figure 13E.
• the dosing system depicted comprises a funnel-shaped filling chamber (la) for receiving a liquid to be aerosolized (an exemplary fill level indicated by a dashed line).
• the filling chamber (la) has a lateral wall
• the funnel-shaped filling chamber (la) is formed by the nebulizer chamber (7) and the aerosol head component (14).
• the dosing system further comprises a plunger (4) which is at least partially insert- able into the filling chamber (la), and which is sized and configured such as to sealingly contact the lateral wall (42) of the filling chamber (la) upon being at least partially inserted, such as to isolate a metered volume of the liquid which is smaller than the fill volume.
• the upper section of the plunger (4) further comprises, or is associated with, an overflow chamber (5a) which is shaped like a funnel or an inverted umbrella having a funnel wall
• the plunger (4) is gradually inserted into the filling chamber (la) by screwing on the lid (9). Some excess liquid may be displaced by the plunger (4) and pushed into the overflow chamber (5a); more specifically the plunger (4) and the funnel wall (43) displace the excess such that it overflows into the overflow chamber (5a).
• the sealing lip (31) forms a seal between the lid (9) and the aerosol head component (14) while the plunger (4) seal- ingly contacts the lateral walls (42) of the filling chamber (la).
• the funnel wall (43) associated with the plunger (4) forms a seal with the upper part of the filling chamber (la) formed by the aerosol head component (14).
• the metered volume is separated from the non-metered portion of the liquid and ready for nebulization through the mesh (8).
• figures 14A and B depict a rather large plunger (4) which is intended for dosing very small volumes
• this embodiment is also suitable for larger volumes in that the diameter and/or length of the plunger (4) can be reduced, such as to displace less excess from filling chamber (la).
• the dosing system according to the invention and/or the inhalation device according to the invention are equipped with a sensor means which allows detecting when the filling chamber (1) is empty, such as to prompt the automatic switching off of the nebulizing means.
• the inhalation device may further comprise a signaling means (or feedback means) in order to provide specific information to the user, such as that the aerosolization of the metered volume is completed.
• the lid (9) may be removed, excess liquid may be discarded and the dosing system rinsed out with water.
• the dosing system according to the invention allows precise, accurate and reproducible dosing, even in cases when the metered volume is sub- stantially smaller than the fill volume, or the pre-defined, or minimal, fill volume.
• the metered volume is not more than 90 % of the pre-defined fill volume.
• the metered volume is not more than 80 % of the pre-defined fill volume.
• the metered volume is not more than 70 %, 60 %, or 50 % of the pre-filled fill volume.
• the metered volume ranges from e.g. 10 % up to 90 %, or from 20 % to 80 %, of the pre-defined fill volume.
• the metered volume is typically not more than about 5 ml. In many cases, it is not more than about 3 ml, or not more than about 2 ml, or not more than about 1 ml, respectively. Optionally, the metered volume may also be not more than about 0.5 ml, or not more than about 0.4 ml, or even not more than about 0.3 ml.
• the residual volume of liquid in the dosing system i.e. the volume which is not metered and fed to the nebulizing means, is typically at least about 10 ⁇ .
• the re- sidual volume is at least about 20 ⁇ , or 30 ⁇ , or 50 ⁇ , or 100 ⁇ , or 200 ⁇ , or 300 ⁇ , or 500 ⁇ , or 1 ml, or 2 ml, or 3 ml, respectively.
• the invention comprises a dosing system for an inhalation device, comprising
• a filling chamber for receiving a liquid to be aerosolized, the filling chamber having an inlet opening and an outlet opening which is closable at least to the extent as to prevent the liquid received by the filling chamber from flowing through the outlet opening by gravity;
• a plunger which is at least partially insertable into the filling chamber, and which is sized and configured such as to push, while being at least partially inserted into the filling chamber after the filling chamber has received at least a pre-defined fill volume of the liquid, a metered volume of the liquid out from the filling chamber through the outlet opening, wherein the metered volume is smaller than the fill volume.
• the invention provides a dosing system for an inhalation device, comprising:
• a filling chamber for receiving a liquid to be aerosolized, the filling chamber having a lateral wall, an inlet opening and an outlet opening which is configured so as to and/or closable at least to the extent as to prevent the liquid received by the filling chamber from flowing through the outlet opening by gravity;
• a plunger which is at least partially insertable into the filling chamber, and which is sized and configured such as to sealingly contact the lateral wall of the filling chamber upon being at least partially inserted into the filling chamber after the filling chamber has received at least a predefined fill volume of the liquid such as to isolate a metered volume of the liquid; wherein the metered volume is smaller than the fill volume.
• the filling chamber for receiving a liquid to be aerosolized, the filling chamber having (a) an inlet opening and (b) an outlet opening which is closable at least to the extent such as to prevent the liquid received by the filling chamber from flowing through the outlet opening by gravity;

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• 2014
  • 2014-08-18 CN CN201480056129.2A patent/CN105636628B/zh active Active
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