WO2022161937A1 - Corps d'inhalateur formant un passage - Google Patents
Corps d'inhalateur formant un passage Download PDFInfo
- Publication number
- WO2022161937A1 WO2022161937A1 PCT/EP2022/051601 EP2022051601W WO2022161937A1 WO 2022161937 A1 WO2022161937 A1 WO 2022161937A1 EP 2022051601 W EP2022051601 W EP 2022051601W WO 2022161937 A1 WO2022161937 A1 WO 2022161937A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- conduit
- inhaler
- passage
- compound
- inhaler body
- Prior art date
Links
- 239000000126 substance Substances 0.000 claims abstract description 43
- 150000001875 compounds Chemical class 0.000 claims description 173
- 238000009423 ventilation Methods 0.000 claims description 115
- 239000000443 aerosol Substances 0.000 claims description 21
- 238000011144 upstream manufacturing Methods 0.000 claims description 15
- 239000007788 liquid Substances 0.000 claims description 13
- 239000011148 porous material Substances 0.000 claims description 12
- 229940071648 metered dose inhaler Drugs 0.000 claims description 6
- 210000004072 lung Anatomy 0.000 description 16
- 239000003595 mist Substances 0.000 description 14
- 230000009467 reduction Effects 0.000 description 10
- 230000015572 biosynthetic process Effects 0.000 description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 9
- 239000000654 additive Substances 0.000 description 8
- 230000000996 additive effect Effects 0.000 description 8
- 230000000694 effects Effects 0.000 description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 7
- 230000009286 beneficial effect Effects 0.000 description 7
- 238000009826 distribution Methods 0.000 description 7
- 238000004519 manufacturing process Methods 0.000 description 7
- 239000000463 material Substances 0.000 description 7
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- 238000001746 injection moulding Methods 0.000 description 6
- 239000013543 active substance Substances 0.000 description 5
- 230000008901 benefit Effects 0.000 description 5
- 239000003814 drug Substances 0.000 description 5
- 229940079593 drug Drugs 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- SNICXCGAKADSCV-JTQLQIEISA-N (-)-Nicotine Chemical compound CN1CCC[C@H]1C1=CC=CN=C1 SNICXCGAKADSCV-JTQLQIEISA-N 0.000 description 3
- 239000004677 Nylon Substances 0.000 description 3
- 230000001133 acceleration Effects 0.000 description 3
- 230000003247 decreasing effect Effects 0.000 description 3
- 229960002715 nicotine Drugs 0.000 description 3
- SNICXCGAKADSCV-UHFFFAOYSA-N nicotine Natural products CN1CCCC1C1=CC=CN=C1 SNICXCGAKADSCV-UHFFFAOYSA-N 0.000 description 3
- 229920001778 nylon Polymers 0.000 description 3
- 239000004094 surface-active agent Substances 0.000 description 3
- 241000217377 Amblema plicata Species 0.000 description 2
- 239000004745 nonwoven fabric Substances 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 229920000136 polysorbate Polymers 0.000 description 2
- 229950008882 polysorbate Drugs 0.000 description 2
- 239000003380 propellant Substances 0.000 description 2
- 230000002685 pulmonary effect Effects 0.000 description 2
- 238000005549 size reduction Methods 0.000 description 2
- 239000002759 woven fabric Substances 0.000 description 2
- FUFLCEKSBBHCMO-UHFFFAOYSA-N 11-dehydrocorticosterone Natural products O=C1CCC2(C)C3C(=O)CC(C)(C(CC4)C(=O)CO)C4C3CCC2=C1 FUFLCEKSBBHCMO-UHFFFAOYSA-N 0.000 description 1
- MFYSYFVPBJMHGN-ZPOLXVRWSA-N Cortisone Chemical compound O=C1CC[C@]2(C)[C@H]3C(=O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 MFYSYFVPBJMHGN-ZPOLXVRWSA-N 0.000 description 1
- MFYSYFVPBJMHGN-UHFFFAOYSA-N Cortisone Natural products O=C1CCC2(C)C3C(=O)CC(C)(C(CC4)(O)C(=O)CO)C4C3CCC2=C1 MFYSYFVPBJMHGN-UHFFFAOYSA-N 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 229910000831 Steel Inorganic materials 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 229960004544 cortisone Drugs 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 150000005828 hydrofluoroalkanes Chemical class 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000002452 interceptive effect Effects 0.000 description 1
- 229930003658 monoterpene Natural products 0.000 description 1
- 150000002773 monoterpene derivatives Chemical class 0.000 description 1
- 235000002577 monoterpenes Nutrition 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 210000002200 mouth mucosa Anatomy 0.000 description 1
- 231100000957 no side effect Toxicity 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 1
- -1 polypropylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920000053 polysorbate 80 Polymers 0.000 description 1
- 229940068968 polysorbate 80 Drugs 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 229920006395 saturated elastomer Polymers 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 239000010959 steel Substances 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
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
- A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
-
- 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
- A61M11/001—Particle size control
-
- 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
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0021—Mouthpieces therefor
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
- B05B1/00—Nozzles, spray heads or other outlets, with or without auxiliary devices such as valves, heating means
- B05B1/14—Nozzles, spray heads or other outlets, with or without auxiliary devices such as valves, heating means with multiple outlet openings; with strainers in or outside the outlet opening
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
- B05B1/00—Nozzles, spray heads or other outlets, with or without auxiliary devices such as valves, heating means
- B05B1/34—Nozzles, spray heads or other outlets, with or without auxiliary devices such as valves, heating means designed to influence the nature of flow of the liquid or other fluent material, e.g. to produce swirl
- B05B1/3402—Nozzles, spray heads or other outlets, with or without auxiliary devices such as valves, heating means designed to influence the nature of flow of the liquid or other fluent material, e.g. to produce swirl to avoid or to reduce turbulencies, e.g. comprising fluid flow straightening means
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
- B05B1/00—Nozzles, spray heads or other outlets, with or without auxiliary devices such as valves, heating means
- B05B1/34—Nozzles, spray heads or other outlets, with or without auxiliary devices such as valves, heating means designed to influence the nature of flow of the liquid or other fluent material, e.g. to produce swirl
- B05B1/3405—Nozzles, spray heads or other outlets, with or without auxiliary devices such as valves, heating means designed to influence the nature of flow of the liquid or other fluent material, e.g. to produce swirl to produce swirl
- B05B1/341—Nozzles, spray heads or other outlets, with or without auxiliary devices such as valves, heating means designed to influence the nature of flow of the liquid or other fluent material, e.g. to produce swirl to produce swirl before discharging the liquid or other fluent material, e.g. in a swirl chamber upstream the spray outlet
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D83/00—Containers or packages with special means for dispensing contents
- B65D83/14—Containers or packages with special means for dispensing contents for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a propellant
- B65D83/75—Aerosol containers not provided for in groups B65D83/16 - B65D83/74
- B65D83/753—Aerosol containers not provided for in groups B65D83/16 - B65D83/74 characterised by details or accessories associated with outlets
-
- A—HUMAN NECESSITIES
- A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
- A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
- A24F40/00—Electrically operated smoking devices; Component parts thereof; Manufacture thereof; Maintenance or testing thereof; Charging means specially adapted therefor
- A24F40/40—Constructional details, e.g. connection of cartridges and battery parts
- A24F40/48—Fluid transfer means, e.g. pumps
- A24F40/485—Valves; Apertures
-
- A—HUMAN NECESSITIES
- A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
- A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
- A24F42/00—Simulated smoking devices other than electrically operated; Component parts thereof; Manufacture or testing thereof
- A24F42/60—Constructional details
-
- 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
- A61M11/001—Particle size control
- A61M11/003—Particle size control by passing the aerosol trough sieves or filters
-
- 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
- A61M2206/00—Characteristics of a physical parameter; associated device therefor
- A61M2206/10—Flow characteristics
- A61M2206/18—Coaxial flows, e.g. one flow within another
Definitions
- the invention relates to an inhaler body for an inhaler for administering a substance to a person.
- the invention also relates to an inhaler comprising such an inhaler body.
- a metered-dose inhaler is a device that delivers a specific amount of a substance, e.g. medication, to the lungs.
- the substance may be delivered in a compound the form of a short burst of aerosol that is usually self-administered by the user via inhalation.
- Administration in lungs needs only a fraction, e.g. 3/7, of the active substance in oral administration. This may reduce side effects. For example, with cortisone, no side effects seem to appear when administered in lungs. Also, administering medical drugs over the lungs also may mean a full effect immediately, whereas orally it can take up to 3 hours or more until there is a full effect.
- Inhalers may be provided in different types, e.g. as pressurized metered-dose inhalers (pMDI), dry powder inhalers (DPI), or water based inhalers.
- pMDI pressurized metered-dose inhalers
- DPI dry powder inhalers
- water based inhalers water based inhalers.
- Inhalers for metered dose aerosols typically comprise a housing for receiving a substance container.
- a container may contain a propellant and the active substance.
- the container may comprise a valve, and upon actuation of the valve a defined amount of the substance is delivered.
- An inhaler body of the inhaler typically comprises a conduit forming an atomizing nozzle through which an aerosol is emitted into a mouthpiece of the inhaler body, which aerosol can be inhaled by the user.
- a problem with known inhalers is that they emit a relatively short puff with high particle velocity. This requires good coordination in actuating the puff and inhaling the aerosol cloud. Usually, part of the drug is not inhaled.
- a challenge with inhalers is to obtain small droplet sizes in the mist produced by the inhaler. Small droplet sizes will contribute to effectively distribute the substance to the user’s body.
- Some water based inhalers give a good plume, but they are complicated to manufacture and therefore expensive. Also, such inhalers may require for each administration a relatively large dose.
- US2010059050A1 discloses an inhaler with components having an aerodynamic crosssection, arranged in a star shape relative to one another. It is suggested that this prevents relatively large particles from passing through the inhalation channel.
- US2007175469A1 relates to MDIs, and describes a nozzle duct with a flat cross section. It is suggested that a higher delivery efficiency can be achieved than by a circular or quasi circular duct, since the larger cross sectional perimeter results in a larger duct surface that is in contact with the drug or liquid so that better breaking up can be achieved due to higher sheer forces without changing the mass flow significantly.
- an inhaler body for an inhaler for administering a substance to a person wherein the inhaler body forms a passage.
- the passage has a cross-sectional area that varies along the passage, and the passage comprises a conduit which forms the narrowest part of the passage.
- the ratio of the square of the conduit perimeter length and the cross-sectional area of the conduit is higher than 4 times 7t, wherein the inhaler body comprises a conduit body, and the conduit is formed in the conduit body, wherein, at an outlet of the conduit, the conduit body presents an outlet surface which is angled so as to face partly in a downstream direction of the conduit, and partly radially outwardly in relation to the conduit.
- the inhaler body may comprise the passage.
- the passage may be adapted to guide a compound including the substance from a container to an outlet opening of the inhaler body.
- the conduit may be adapted to guide the compound, in a longitudinal direction of the conduit.
- the cross-sectional area of the passage may be an area in a cross-section that is transverse to the longitudinal direction of the conduit.
- the conduit may have a maximum transverse dimension of less than 1 mm.
- the conduit may form an orifice or an atomizing nozzle.
- the substance may be a medicament or some other substance, such as nicotine.
- the substance may be administered to a person via the lungs of the person.
- the outlet opening of the inhaler body may be adapted to be positioned at or in a person’s mouth to direct the compound into the person’s mouth.
- the inhaler body may form a part of an inhaler.
- the inhaler may be adapted for a metered dose aerosol.
- the inhaler may be arranged to release the compound from the container by means of a so-called bag-on-valve (BoV) arrangement.
- the conduit may be provided downstream of the bag-on-valve arrangement.
- the conduit may be formed in a conduit body of the inhaler body.
- the conduit may provide an orifice in the inhaler body.
- the conduit may create an aerosol, or reduce the droplet size of an aerosol.
- the compound In the container, the compound may be in liquid form. When reaching the conduit, the compound may be an aerosol. The transition from a liquid to an aerosol may be provided by an expansion of the compound when leaving the container.
- the passage may comprise an expansion chamber upstream of the conduit.
- the inhaler body may form an expansion chamber upstream of the conduit.
- the expansion chamber may have any suitable volume, for example 100-300 pl 3 , e.g. 175 l 3 . Preferably, the expansion chamber volume is at least five times the volume of the liquid released.
- the expansion chamber may be gradually narrowed towards the conduit. In the expansion chamber, the compound may form droplets, which are mixed with gas.
- an additive in liquid state in the container, may turn into a gaseous state in the expansion chamber.
- the compound may move into a droplet state in the expansion chamber, mixed with the additive in a gaseous form.
- the inhaler body may be adapted to receive the compound from the container, and the inhaler body may be adapted to guide the compound towards the conduit.
- the conduit is preferably adapted to guide the compound, in the conduit longitudinal direction, towards the outlet opening of the inhaler body.
- the conduit longitudinal direction may be defined by a line intersecting a center of the conduit at an inlet of the conduit, and a center of the conduit at an outlet of the conduit.
- the transverse direction of the conduit may be perpendicular to the longitudinal direction.
- the inhaler body may form the conduit such that, in a transverse cross-section of the conduit, the ratio of the square of the conduit perimeter length and the cross-sectional area of the conduit is higher than that of a circle.
- Said ratio is 4 multiplied by 7t, approximately 12.57, for a circle.
- a circle can be viewed as a special case of an ellipse where the major and minor axes are of equal length.
- said ratio is higher than 4 times by it throughout the entire conduit.
- the ratio of the square of the conduit perimeter length and the cross- sectional area of the conduit is higher than 15, or higher than 20.
- the conduit is formed in the conduit body, wherein at an outlet of the conduit, the conduit body presents an outlet surface which is angled so as to face partly in a downstream direction of the conduit, and partly radially outwardly in relation to the conduit.
- the angled outlet surface may form a limitation of the passage adapted to guide the compound from the container to the outlet opening of the inhaler body.
- the angled outlet surface may form a limitation of a transport chamber downstream of the conduit.
- the transport chamber may form a part of the passage.
- the transport chamber may have, in a cross-section perpendicular to the conduit longitudinal direction, a periphery which is radially completely outside of any part of the conduit periphery in a conduit transverse cross-section.
- the angled outlet surface may extend partly upstream, and partly outwards, from the conduit outlet.
- said perimeter length to area ratio of the conduit will provide for a longer perimeter for a given compound flow.
- the inner surface of the conduit will be larger in relation to a volume of the conduit, compared to a conduit with a circular cross-section. Thereby, the compound will be exposed to a larger surface. Since droplets, in parts of the flow which are close to the conduit surface, will tend to break up more easily, the inhaler body will serve to tear apart droplets of the compound to a greater extent.
- the increased parameter to cross-sectional area ratio will increase the turbulence at an exit of the compound from the conduit outlet. This will further increase the breaking up of the droplets of the compound. Thereby, the droplet mass median aerodynamic diameter (MMAD) of the compound will be decreased.
- MMAD droplet mass median aerodynamic diameter
- the outlet surface may be angled so as to face radially outwardly in the downstream direction of the conduit.
- the invention allows for the outlet surface being swept backwards in relation to the flow direction in the conduit. Thereby, there is a reduced tendency of the boundary surfaces of the transport chamber downstream of the conduit interfering with the mist of the compound.
- a turbulent flow forming at the outlet of the conduit may have a tendency to expand in the downstream direction, as well as outwardly in the transverse direction.
- the turbulent flow forming at the outlet of the conduit may also have a tendency to expand in the upstream direction, transversely outside of the conduit outlet.
- a surface oriented in the transverse direction of the conduit may disturb the turbulence formation. The backwards angle of the outlet surface allows this upstream expansion, without disturbing it. This enhances the turbulence formation at the conduit outlet. This further facilitates the breaking up of the compound droplets. This will improve the administration of the substance in the lungs of the user.
- the outlet surface is angled, so that it leans towards the upstream direction, as seen in a crosssection of the inhaler body, coinciding with the longitudinal direction of the conduit.
- the outlet surface may be conical. Thereby, the conduit outlet would be at the apex of the cone.
- the outlet surface may be pyramid-shaped, with the conduit outlet at the apex of the pyramid.
- the outlet surface may form an angle with the transverse direction of the conduit of at least 10 degrees.
- the outlet surface forms an angle with the transverse direction of the conduit of at least 20 degrees, for example 30 degrees.
- the outlet surface may form an angle with the transverse direction of the conduit of less than 70 degrees, preferably less than 50 degrees, preferably less than 45 degrees. Where said angle is less than 45 degrees.
- manufacturing problems may be avoided. Specifically, enough material may be ensured for an expansion chamber, located upstream of the conduit.
- the outlet surface may be straight. However, in some embodiments, the outlet surface may be curved in a crosssection which is parallel to the conduit longitudinal direction. Thereby, the outlet surface may form a plurality of angles with the transverse direction of the conduit. These angles may be within 20-45 degrees.
- the inhaler body may form a transport chamber downstream of the conduit.
- the transport chamber may have a width, in any direction which is transverse to the conduit, of at least 3.0 mm, preferably at least 4.0 mm.
- the transport chamber may be delimited transversely at the conduit outlet by one or more transport chamber surfaces of the transport chamber.
- the transport chamber surfaces may be sufficiently far from the conduit outlet, to not disturb the formation of turbulence of compound exiting the conduit.
- the angled outlet surface may form limitation of the transport chamber at an upstream end of the transport chamber.
- the one or more transport chamber surfaces may extend from the angled outlet surface and in a downstream direction in the passage.
- the one or more transport chamber surfaces may extend to a permeable sheet, exemplified below.
- the conduit may have a constant cross-section.
- the compound may gain velocity due to a reduced cross-sectional area of the conduit in relation to the expansion chamber.
- the conduit transverse cross-sectional shape is such that any position in the conduit is within 0.3 mm from the conduit wall. As exemplified below, this may secure that all droplets in the compound are broken up. Thereby, the droplet size distribution of the inhaler can be reduced.
- the conduit may have a maximum transverse dimension which is at least 0.2 mm, preferably at least 0,27 mm, for example 0.35 mm.
- the inhaler body forms the conduit such that, in the conduit, at least one portion of the surface of the inhaler body is convex as seen in a transverse cross-section of the conduit.
- the inhaler body may form the conduit such that at least one portion of the conduit cross-section perimeter is convex.
- the at least one portion of the surface of the inhaler may curve outwards in the conduit.
- the curvature may provide a smooth surface, or the surface may present one or more comers in the transverse cross-section of the conduit.
- the inhaler body may form a convex shape of the perimeter. One or more parts may be shaped inwards in the conduit. Thereby, the likelihood of the compound droplets being in the vicinity of the conduit wall, to thereby be broken up, is increased.
- the inhaler body forms the conduit by at least one, preferably at least two, preferably at least three ridges in the conduit extending at least partly in the conduit longitudinal direction. Where there are at least two or at least three ridges, the ridges are preferably circumferentially distributed in the conduit. In a transverse cross-section of the conduit, the one or more ridges may extend towards a centerline of the conduit.
- the transverse cross-sectional shape of the conduit may be twisted in the longitudinal direction of the conduit.
- the ridges may, in addition to extending in the conduit longitudinal direction, extend in a circumferential direction.
- the ridges may form helices in the conduit.
- the inhaler body may form the conduit such that, in a crosssection of the inhaler body perpendicular to the longitudinal direction of the conduit, the conduit presents a center and at least three legs extending radially from the center.
- the ratio between the length of the perimeter of the conduit cross-section, and the conduit cross- sectional area may be relatively high.
- This perimeter length to area ratio will serve to tear apart droplets of the compound to a high extent.
- the conduit cross-sectional perimeter will be partly closer to the center of the compound flow. Thereby, the droplets in a larger portion of the administered compound, or all of it, may be close to the conduit wall, and thereby broken when passing through the conduit.
- the one or more ridges in the conduit will increase the turbulence at an exit of the compound from the conduit outlet. As suggested, this will further increase the breaking up of the droplets of the compound.
- MMAD droplet mass median aerodynamic diameter
- the number of ridges is 3-7, for example 4.
- a radial distance from a top of any of the ridges to a bottom of the respective ridge is less than 0.3 mm, preferably less than 0.2 mm, preferably less than 0.15 mm.
- the radial distance from a top of any of the ridges to a bottom of the respective ridge is at least 0.05 mm.
- the distance between tops of two adjacent ones of any of the ridges is less than 0.3 mm, preferably less than 0.2 mm, preferably less than 0.15 mm.
- the distance between tops of two adjacent ones of any of the ridges is at least 0.05 mm.
- the radial extension of any of the legs formed by the conduit, in a transverse cross-section of the conduit may be less than less than 0.3 mm, preferably less than 0.2 mm, preferably less than 0.15 mm, for example 0.1 mm.
- the lateral extension of any of the legs formed by the conduit, in a transverse cross-section of the conduit may be less than less than 0.3 mm, preferably less than 0.2 mm, preferably less than 0.15 mm, for example 0.12 mm.
- Embodiments of the invention provides significantly reduced droplet sizes.
- An inhaler body conduit with a circular cross-section may, with a diameter of 1.0 mm, provide a breaking up of the compound within a distance of 0.3 mm from the conduit wall. This means that there will be a center part of the conduit, with a diameter of 0.4 mm, where the compound droplets are not broken up. As a result, the aerosol downstream of the conduit will include relatively large droplets.
- embodiments of the invention with said ridges forming the conduit, may provide for any position in the conduit being within 0.3 mm from the conduit wall. Thereby all droplets in the compound may be broken up. More generally, the droplet size distribution of the inhaler can be reduced.
- the reduced droplet size allows for reducing the amount of the active substance administered with each “puff’ of the inhaler.
- Embodiments of the invention allows for a droplet mass median aerodynamic diameter (MMAD) of below 5 pm.
- MMAD droplet mass median aerodynamic diameter
- the body absorption of the active substance may be improved.
- the amount of compound released at each administration may be reduced.
- the released amount of compound at an administration may be e.g. 35 pl in liquid form.
- the number of dosages may thereby be 270/35.
- the reduced amount of compound released at each administration may reduce the density of the compound in the passage. This facilitates the formation of turbulence in the passage of the inhaler body. This in turn contributes to reducing the compound droplet sizes.
- a synergistic effect may be provided since the reduced amount of compound released, allowed by features of the inhaler body according to embodiments of the invention, allows for further reducing the droplet size, since it facilitates turbulence formation.
- the reduced amount of compound released at each administration makes inhalation of the compound easier for the user.
- the small droplet size may be reached with embodiments of the invention, without any heating or burning of any substance.
- the inhaler may be waterbased without polypropylene, or hydrofluoroalkane (HF A) propellants.
- HF A hydrofluoroalkane
- inventions of the inhaler body according to the invention provides manufacturing advantages.
- the inhaler body is advantageously made in plastic.
- any attempt to manufacture, with injection molding, an inhaler body with a conduit having a circular cross-section with a small diameter, e.g. 0.1-0.15 mm, will not be feasible, due to a lack of material in the injection molding tool.
- the cross-section of the conduit may be in the shape of a cross.
- the conduit may have a maximum transverse dimension of less than 1.0 mm, preferably less than 0.6 mm, preferably less than 0.5 mm, for example 0.35 mm.
- the conduit has a length in the longitudinal direction of at least 0.2 mm, preferably at least 0.4 mm.
- the conduit has a length in the longitudinal direction of less than 1.2 mm, preferably at least 0.9 mm, for example 0.65 mm.
- the expansion chamber presents an area, in a cross-section which is perpendicular to the conduit longitudinal direction, which is larger than a transverse cross-sectional area of the conduit, wherein the expansion chamber gradually narrows towards the conduit.
- a first reduction of the droplet sizes of the compound may be provided in the expansion chamber, due to the liquid expansion, turbulence from the walls in the expansion chamber, and the compound moving into a droplet state, mixed with the additive in a gaseous form, as exemplified below.
- an aspect of the invention provides an inhaler body according to claim 8.
- the inhaler body may, or may not, comprise a conduit body which presents, at an outlet of the conduit, an outlet surface which is angled so as to face partly in a downstream direction of the conduit, and partly radially outwardly in relation to the conduit.
- the inhaler body forms a turbulence generating surface at an inlet of the conduit which turbulence generating surface forms a limitation of the expansion chamber, which turbulence generating surface forms an angle to the conduit transverse direction which is less than 30 degrees, preferably less than 15 degrees, for example 0 degrees.
- a step in the transverse cross-sectional area of the passage may be at the inlet of the conduit, a step in the transverse cross-sectional area of the passage.
- the turbulence generating surface promotes turbulence in the compound flow entering the conduit. Thereby, a compound droplet size reduction at the conduit will be facilitated.
- the passage comprises a transport chamber downstream of the conduit, wherein the transport chamber has, in a cross-section perpendicular to the conduit longitudinal direction, a periphery which is radially completely outside of any part of the conduit periphery in a conduit transverse cross-section.
- the inhaler body forms the transport chamber downstream of the conduit.
- the transport chamber may be provided between the conduit and the outlet opening of the inhaler body.
- a general direction of a flow of the compound in the transport chamber is parallel with the conduit longitudinal direction.
- the transverse shape of the conduit serves to increase the turbulence of the flow with the compound, and this turbulence stimulates the reduction of compound droplet sizes when the compound leaves the conduit.
- the inhaler body comprises, downstream of the conduit, a sheet that is permeable to an aerosol of the compound flowing out of the conduit.
- the permeable sheet may be provided between the conduit and the outlet opening of the inhaler body.
- the permeable sheet may extend transversely to the longitudinal direction of the conduit.
- the transport chamber may extend from the conduit to the permeable sheet.
- the permeable sheet may be formed by a nonwoven fabric, a woven fabric, or a mesh.
- the permeable sheet may be formed by a steel mesh, or a nylon net, e.g. a nylon weave.
- the sheet may reduce the droplet size further.
- a first reduction of the droplet sizes of the compound may be provided by the conduit, and a second reduction of the droplet sizes of the compound may be provided by the permeable sheet.
- a first reduction of the droplet sizes of the compound may be provided in the expansion chamber
- a second reduction of the droplet sizes of the compound may be provided by the conduit
- a third reduction of the droplet sizes of the compound may be provided by the permeable sheet.
- the reduced droplet size provided by embodiments of the invention facilitates the passing of the compound through the permeable sheet. This in turn facilitates the further reduction of the droplets by the sheet.
- the sheet may reduce the velocity of the compound mist, which facilitates inhaling of the mist.
- the compound velocity may be reduced by 50%. This reduces the need for the user’s coordination in actuating a puff and inhaling the aerosol cloud. This will increase the amount of the substance being inhaled by the user.
- an aspect of the invention provides an inhaler body according to claim 11.
- the inhaler body may, or may not, comprise a conduit body which presents, at an outlet of the conduit, an outlet surface which is angled so as to face partly in a downstream direction of the conduit, and partly radially outwardly in relation to the conduit.
- the sheet has pores with diameters within the range of 40pm - 100pm, preferably 60pm - 80pm. With a pore diameter with said range, the sheet may reduce the droplet size further.
- a particular advantage is provided by the combination of the permeable sheet downstream of the conduit, and the ratio of the square of the conduit perimeter length and the cross-sectional area of the conduit being higher than that of a circle, as exemplified above.
- a “queue” may be formed if the amount of released compound is too large.
- the reduced droplet size provided by the conduit allows a reduced pore diameter of the sheet. As a result, the strings of the sheet, between the pores, will be denser.
- MMAD droplet mass median aerodynamic diameter
- said ratio of the square of the conduit perimeter length and the cross-sectional area of the conduit may be selected to control the droplet MMAD, e.g. by changing the number of ridges in the conduit.
- the sheet pore diameter as exemplified above, may be selected to control the droplet MMAD.
- the droplet MMAD may also be controlled by the metered amount of compound delivered; an increased amount delivered gives more liquid through the inhaler body passage, relating in more droplets having to be broken, giving a larger droplet MMAD.
- the MMAD may be larger than 20pm.
- the MMAD may be 10pm - 20pm, for example 15pm.
- the MMAD may be 5pm - 10pm, for example 7.5pm.
- the MMAD may be smaller than 5pm.
- the sheet may increase the temperature of the compound mist. This will make it more pleasant to inhale, avoiding any “cold-shock”.
- the sheet is adapted to flex by means of the pressure of a flow of compound aerosol from the conduit.
- the pressure may be provided from a “puff’ of the compound.
- the resistance to the compound flow, caused by the sheet may create a pressure gradient across the sheet, causing it to flex.
- Said flexing may be allowed by a suitable stiffness of the sheet.
- the net may obtain a curved form, as seen transversely to the compound flow.
- the compound droplets are spread in the mouth of the inhaler user.
- the sheet works as a deflector.
- Embodiments of the invention provides a broader compound plume at the throat. As a result, a larger portion of the droplets reaches the lungs. In other words, the wide plume gives low standard deviation in lung distribution. Also, the broader plume reduces tendencies of droplets to congregate and form larger droplets.
- a test has shown that an inhaler with an inhaler body with features of an embodiment of the invention allowed 60% of the released compound to reach the lungs. This is a substantial improvement compared to may prior art inhalers.
- the test involved a representation of the mouth and throat of a person, and a so called Next Generation Pharmaceutical Impactor (NGI) as a measuring device in the throat.
- NKI Next Generation Pharmaceutical Impactor
- the distance from the conduit to the sheet is within the range of 2-8 mm, preferably 3-6 mm, for example 4.2 mm.
- the compound mist will be distributed over the sheet so as to avoid the risk of saturation of the sheet while keeping the compound flow within the perimeter of the sheet.
- the maximum extension of the sheet is 7-14 mm.
- the sheet may have a circular shape.
- the diameter of the sheet may be 7-14 mm, for example 10 mm.
- the inhaler body comprises, downstream of the conduit, a mouthpiece forming an outlet chamber as a part of the passage, which outlet chamber presents the outlet opening,
- orientations of the ventilation openings are such that the ventilation flows through the ventilation openings are at least partly directed along the centerline of the outlet chamber
- the outlet chamber formed by the mouthpiece, may have a circular or substantially elliptical cross-section transversely to the centerline of the outlet chamber.
- the outlet chamber may have a constant cross-section.
- the outlet chamber may be formed downstream of the sheet.
- the outlet chamber may be terminated by the outlet opening.
- the outlet opening may open into the outlet chamber.
- the row of ventilation openings comprises a plurality of ventilation openings.
- the ventilation openings may be formed in the mouthpiece, at an end of the mouthpiece which is opposite to the end with the outlet opening.
- the ventilation opening may be located, in a transverse direction in relation to the outlet chamber centerline, at a distance from the outlet chamber centerline.
- the row of ventilation opening may extend circumferentially around the outlet chamber centerline.
- the ventilation openings may be equally distributed circumferentially around the outlet chamber centerline.
- the row of ventilation openings may form a ring of ventilation openings.
- the center of the ring of ventilation openings may be concentric with the centerline of the outlet chamber.
- the ventilation openings may be arranged to direct respective ventilation flows of air from the exterior of the mouthpiece into the outlet chamber.
- air from the surroundings may be introduced to the outlet chamber.
- the ventilation flows may be caused by inhalation of the user.
- the user may put the outlet opening to his/her mouth, maneuver the inhaler to release an amount of the compound from the container, and simultaneously inhale.
- the ventilation flows may be introduced into the outlet chamber simultaneously with the compound flowing through the outlet chamber.
- the ventilation openings will prevent a vacuum effect in the outlet chamber when inhaling.
- the orientation of the ventilation openings may be such that the air flows through the ventilation openings are directed with a component along the outlet chamber centerline, preferably substantially in parallel with the outlet chamber centerline.
- the ventilation flows through the ventilation openings may be substantially parallel with a general flow of the compound in the outlet chamber.
- the general flow of the compound in the outlet chamber may have a direction in parallel with the outlet chamber centerline. While droplets of the compound may move at least partly transversely to the outlet chamber centerline, e.g. due to turbulence, a vector sum of the droplet movements, at a certain point in time, may define the general flow direction.
- a combination of the ventilation flows may surround the flow of the compound through the outlet chamber. Due to the circumferential distribution of the ventilation openings, and the direction of the ventilation flows, the ventilation flows may form a wall of air in the outlet chamber. In other words, the ventilation flows may form a barrier of air in the outlet chamber. The air wall may serve as a buffer between the compound mist and the mouthpiece. Thereby, the risk that the compound mist reaches the mouthpiece is reduced or eliminated. Thereby, a conglomeration of compound droplets on the mouthpiece, reducing the substance administration efficiency, may be prevented.
- the combination of the ventilation flows may surround the flow of the compound as the compound enters through the outlet chamber, and into the user’s mouth and into the user’s mouth.
- the orientation of the ventilation openings being such that the air flows through the ventilation openings are directed with a component along the outlet chamber centerline, allows for keeping the air towards the periphery of the outlet chamber. Thereby the compound plume may be relatively wide.
- the row of ventilation openings has a substantially elliptical shape.
- the row may be defined by a line passing through center points of the openings.
- the major axis of the ellipse formed by the row of ventilation openings may be 35-55 mm, e.g. about 45 mm.
- the minor axis of the ellipse formed by the row of ventilation openings may be 25-45 mm, e.g. about 35 mm.
- the major axis of the ellipse formed by a periphery of the outlet chamber may be 35-65 mm, preferably 40-60 mm, preferably 45-55 mm, e.g. 50 mm.
- the minor axis of the ellipse formed by the periphery of the outlet chamber may be 30-55 mm, preferably 35-50 mm, preferably 40-45 mm, e.g. 42 mm.
- the longitudinal wall portion 2071 may be relatively large. This causes the mouth of the user to open to a relatively large extent. This facilitates the inhalation.
- embodiments of the inhaler body forming the outlet chamber as exemplified herein provide for the wall of air surrounding the plume, and provided by the ventilation openings, mixing, in the mouth of the user, with the compound in a beneficial manner.
- the ventilation openings, and the geometry of the outlet chamber, according to embodiments of the invention allows for controlling the width of the plume of the compound. Thereby the delivery of a substantially constant amount of the substance to the lungs may be secured from one administration to another.
- the extension, along the row of ventilation openings, of material of the mouthpiece between any two of the ventilation openings is less than 10%, preferably less than 5%, for example 1.8%, of the length of the row of ventilation openings.
- the extension, along the row of ventilation openings each intermediate portion will be around 1.8% of the length of the row.
- a ratio of the extension of the ventilation openings along the row of ventilation openings, and the extension, along the row of ventilation openings, of material of the mouthpiece between the ventilation openings is at least 0.5, preferably at least 0.75, for example 1.0. This may assist in providing a sufficient distribution of the ventilation flows around the compound flow.
- respective outlets of the ventilation openings are provided in an interior ventilation surface of the envelope, which ventilation surface is at least partly facing in a direction along the centerline of the outlet chamber.
- the ventilation surface may face towards the outlet opening.
- the mouthpiece may comprise a longitudinal wall portion which extends mainly around the outlet chamber and along the centerline of the outlet chamber.
- the ventilation surface of the mouthpiece is preferably provided on an end portion of the mouthpiece, which is located at an end of the mouthpiece which is opposite to the end presenting the outlet opening.
- said facing of the ventilation surface at least partly in the direction along the outlet chamber centerline is facilitated.
- respective outlets of the ventilation openings are located closer to the longitudinal wall portion than to the centerline of the outlet chamber, or on an interior surface of the longitudinal wall portion.
- the row of ventilation openings comprises at least five, preferably at least ten, preferably at least fifteen, ventilation openings.
- the ventilation openings may be cylindrical.
- the ventilation openings may have a circular crosssection.
- the ventilation openings each have a diameter of 0.5-1.5 mm, for example 1.0 mm.
- a relatively large amount of ventilation openings allows for providing relatively small cylindrical ventilation openings. Such narrow ventilation openings may provide for an acceleration of the air passing through the ventilation openings.
- the ventilation flow may create a jetstream of air.
- the cylindrical shape may facilitate manufacturing, since it facilitates manufacturing a tool for injection molding of the inhaler body.
- the ventilation openings are elongate and extend along the row of openings.
- the width of the ventilation openings are preferably 0.2-1.0 mm, preferably 0.3-0.8 mm, for example about 0.5 mm.
- the respective ventilation opening is narrower between an inlet and an outlet of the ventilation opening, than at the inlet and the outlet. Thereby, a venturi effect may be provided.
- the decreased MMAD of the compound provided by the conduit will be beneficial to the capability of the permeable sheet to reduce the velocity of the compound.
- the reduced compound velocity combined with the acceleration of the ventilation flows provided by the ventilation opening, allows for the compound flow and the ventilation flows to reach the same velocity.
- an inhaler with an inhaler body as claimed herein, comprising a container holding a compound including the substance.
- the inhaler may be a water based inhaler (WBI).
- WBI water based inhaler
- the inhaler may be arranged to release the compound from the container by means of a bag-on-valve (BoV) arrangement.
- the inhaler may be a metered-dose inhaler (MDI).
- MDI metered-dose inhaler
- the inhaler may be for a metered dose aerosol.
- the conduit may adapted to guide the compound, in a longitudinal direction of the conduit, wherein the passage comprises an expansion chamber upstream of the conduit, wherein the expansion chamber presents an area, in a cross-section which is perpendicular to the conduit longitudinal direction, which is larger than a transverse cross-sectional area of the conduit, wherein the expansion chamber gradually narrows towards the conduit.
- the inhaler body may form a turbulence generating surface at an inlet of the conduit which turbulence generating surface forms a limitation of the expansion chamber, which turbulence generating surface forms an angle to the conduit transverse direction which is less than 30 degrees, preferably less than 15 degrees, for example 0 degrees.
- the conduit may have a maximum transverse dimension of less than 1.0 mm, preferably less than 0.6 mm, preferably less than 0.5 mm, for example 0.35 mm.
- the inhaler body may form the conduit such that, in the conduit, at least one portion of the surface of the inhaler body is convex as seen in a transverse cross-section of the conduit.
- the inhaler body may comprise a conduit body, wherein at an outlet of the conduit, the conduit body presents an outlet surface.
- the outlet surface may be angled so as to face partly in a downstream direction of the conduit, and partly radially outwardly in relation to the conduit.
- the outlet surface may be angled so as to face partly in a downstream direction of the conduit, and partly radially inwards in relation to the conduit. In further embodiments, the outlet surface may face in a downstream direction of the conduit.
- the inhaler body may form a transport chamber downstream of the conduit, wherein, at the outlet of the conduit, the transport chamber has a width, in any direction which is transverse to the conduit, of at least 3.0 mm, preferably at least 4.0 mm.
- the passage may be adapted to guide a compound including the substance from the container to an outlet opening of the inhaler body, wherein the inhaler body comprises, downstream of the conduit, a sheet that is permeable to an aerosol of the compound flowing out of the conduit.
- the inhaler may be adapted to release, for an administration of the substance, 15-55 pl, preferably 25-45 pl, for example 35 pl, of the compound in liquid form.
- the conduit preferably has the geometry and dimensions as exemplified above.
- the inhaler body of the inhaler comprises a permeable sheet, as exemplified above.
- the sheet pore diameter may be as exemplified above.
- the substance of the compound may be any substance that is to be administered to the user, for example nicotine.
- the compound may also comprise a mix of water, an acidulant, an alcohol and a surfactant.
- the surfactant may be a polysorbate, e.g. polysorbate 80.
- the acidulant may be citric acid.
- the alcohol may be ethanol.
- the compound may for example comprise the following components: Water at 85 to 99 wt. %, ethanol at 0.5 to 3 wt. %, polysorbate at 0.5 to 3 wt. %, nicotine at 0.2 to 1 wt. %, citric acid at 0.1 to 0.3 wt. %, and monoterpene at 0.02 to 0.1 wt. %.
- the alcohol and surfactant of the compound will contribute to a particular low surface tension.
- This in combination with the released mount of the compound as exemplified herein, the geometry and dimensions of the conduit as exemplified herein, and the pore diameter of the permeable sheet as exemplified herein, will provide a particularly low droplet size of the inhaled compound.
- the amount of released compound has a big impact on the behavior of the compound at the permeable sheet. If the released amount is too high, and the pore size of the sheet is too small, the sheet may become saturated with the compound. Nevertheless, the conduit with geometries as exemplified herein may reduce the droplet size to reduce the risk of such a saturation of the sheet.
- the MMAD of the inhaler was 2.3 pm.
- the MMAD for a prior art pMDI tested was 3.9 pm. Thus, a significant reduction of the MMAD may be accomplished.
- the test was made using NGI, mentioned above.
- the container may have an elongated shape. With a bag-on-valve arrangement, the container can be in any orientation for releasing the compound. Thereby, the container may be aligned with the inhaler body conduit longitudinal direction. Thereby, the inhaler may easily be used at any angle around said longitudinal direction. Further, the container being aligned with the inhaler body conduit longitudinal direction allows for doses of the compound to be released into the expansion chamber, in line with the conduit longitudinal direction. This allows a beneficial flow in expansion chamber. In particular, the flow may be symmetrical in relation to at least two orthogonal planes through which the conduit longitudinal direction extends. Further, the general flow direction in the expansion chamber may be straight.
- a pressurized metered-dose inhaler will typically be arranged so that the is an angled general compound flow in the expansion chamber.
- the straight general flow direction in the expansion chamber will provide a higher velocity in the conduit. This facilitates the breaking up of the droplets in the compound.
- fig. 1 shows an inhaler according to an embodiment of the invention
- fig. 2 shows a longitudinal cross-section of the inhaler in fig 1, partly disassembled
- fig. 2a and fig. 2b show schematic cross-sectional views of a valve of the inhaler in fig. 1
- fig. 3 shows a detail of fig. 2
- fig. 3 a shows a detail of the view in fig. 3, with a flow phenomenon in a passage of the inhaler illustrated
- fig. 4 shows a transverse cross-section of a conduit in the passage of the inhaler in fig. 1
- fig. 5 shows a front view of the inhaler in fig. 1, fig.
- FIG. 6 shows a detail of the view in fig. 3, with flow phenomena in the passage of the inhaler illustrated
- fig. 7 shows a front view of an inhaler according to an alternative embodiment of the invention
- fig. 8 shows a view corresponding to a detail of fig. 3, of an inhaler according to a further alternative embodiment of the invention
- fig. 9a - 9f show transverse cross-sections of conduits in passages of inhalers according to additional embodiments of the invention.
- Fig. 1 shows an inhaler 1 for administering a substance to a person.
- the inhaler comprises an inhaler body 2, with a housing 231 for holding a container 3 for holding a compound including the substance.
- the housing has an elongated shape.
- the housing 231 is aligned with the inhaler body 2.
- the container 3 is aligned with the inhaler body 2.
- the container has a cylindrical shape.
- the housing has a cylindrical shape.
- the inhaler body comprises an outlet opening 204 for releasing doses of the compound into the mouth of a user.
- the inhaler is arranged to release the compound from the container 3 by means of a so-called bag-on-valve (BoV) arrangement 301.
- the container comprises a bag 302 holding the compound.
- the container holds an increased pressure around the bag 302. Said pressure is for example about 6 bar, i.e. 600,000 Pa.
- the inhaler may be adapted to release, for an administration of the substance, a predetermined amount of the compound, e.g. 35 pl in liquid form.
- the bag-on-valve arrangement 301 is arranged to release a metered dose of the compound.
- the container 3 is pushed towards the outlet opening 204, as exemplified below.
- the bag-on-valve arrangement 301 comprises a stem 3011 and a collar 3012 externally of the stem. A seal is provided between the stem 3011 and the collar 3012. A cavity 3013 is formed in the stem.
- the volume of the cavity is the volume of a dose of the compound.
- stem cavity 3013 is aligned with a collar opening 3014.
- the collar 3012 is moved in relation to the stem 3011. Thereby, the collar opening 3014 is moved so as to expose the stem cavity to release the dose.
- the inhaler body forms a passage 201, 203, 205, 208 adapted to guide the compound from the container 3 to the outlet opening 204 of the inhaler body.
- the passage may be formed by a passage body 221 of the inhaler body.
- the passage body may form a part of the inhaler body.
- the inhaler body, or at least the passage body 221, may be produced by injection molding.
- the housing 231 presents a housing opening 232, at an end of the inhaler body 2 which is opposite to the end at which the outlet opening 204 is located.
- the container 3 may be moved into the housing 231 via the housing opening 232.
- the container may also be moved out of the housing, e.g. to be replaced.
- the inhaler also comprises a maneuvering device 4.
- the maneuvering device is arranged to allow a user to activate the inhaler to release, for an administration of the substance, a dose of the compound.
- the maneuvering device is provided in the form of a sleeve.
- the sleeve has a cylindrical shape, and is open at one of its ends.
- the sleeve 4 is adapted to enclose the housing 231. Thereby, the sleeve 4 can be removed from the housing, so as to expose the housing opening 232, e.g. for inserting or removing the container 3.
- the inhaler body 2 forms an expansion chamber 201 downstream of the bag-on-valve arrangement 301. 1.e. the expansion chamber 201 is formed downstream of the container. The expansion chamber forms a part of the passage adapted to guide the compound from the container 3 to the outlet opening 204.
- the inhaler body further comprises conduit body 202 forming a conduit 203, described further below.
- the conduit 203 forms a part of the passage adapted to guide the compound from the container 3 to the outlet opening 204.
- the passage has a cross-sectional area that varies along the passage, and the conduit forms the narrowest part of the passage.
- the conduit body 202 may form a part of the passage body 221.
- the expansion chamber 201 is adapted to guide the compound towards the conduit.
- the conduit is adapted to guide the compound, in a longitudinal direction of the conduit, towards the outlet opening 204 of the inhaler body.
- the outlet opening 204 is formed by a mouthpiece 207 forming an outlet chamber 208.
- the outlet chamber 208 forms a part of the passage adapted to guide the compound from the container 3 to the outlet opening 204.
- the mouthpiece comprises a longitudinal wall portion 2071 which extend mainly around the outlet chamber and in the longitudinal direction of the conduit.
- the longitudinal wall portion 2071 has a substantially elliptical shape in a cross-section transverse to the conduit longitudinal direction.
- the longitudinal wall portion 2071 has a substantially elliptical shape in a cross-section transverse to the general direction of the compound flow.
- a lip abutment protrusion 209 is provided externally of the longitudinal wall portion 2071. The lip abutment protrusion extends around the longitudinal wall portion 2071.
- the sleeve 4 is at an end which is opposite to its open end provided with a pushing arrangement, in this example in the form of a sleeve end wall 401 and one or more ribs 402 fixed thereto.
- a pushing arrangement in this example in the form of a sleeve end wall 401 and one or more ribs 402 fixed thereto.
- the sleeve 4 is arranged to that, when the sleeve 4 is enclosing the housing 231, a user may put his/her lip around the longitudinal wall portion 2071, and push the pushing arrangement 401, 402. Thereby the lip abutment protrusion will abut the user’s lips, which provide a reaction force to the pushing of the pushing arrangement.
- the pushing arrangement will push the container 3 so as to release a dose of the compound.
- the external transverse shape of the longitudinal wall portion 2071 may be substantially elliptical.
- the major axis of the ellipse may be 37-67 mm, preferably 42-62 mm, preferably 47-57 mm, e.g. 52 mm.
- the minor axis of the ellipse may be 32-57 mm, preferably 37-52 mm, preferably 42-47 mm, e.g. 44 mm.
- the longitudinal wall portion 2071 may be relatively large. This causes the mouth of the user to open to a relatively large extent. This facilitates the inhalation.
- the inhaler body forms a transport chamber 205 downstream of the conduit 203. Thereby, a widening of the path of the compound is provided.
- the transport chamber forms a part of the passage adapted to guide the compound from the container 3 to the outlet opening 204.
- the inhaler body comprises, downstream of the conduit 203, a sheet 206 that is permeable to an aerosol of the compound flowing out of the conduit.
- the permeable sheet is provided between the conduit 203 and the outlet opening 204 of the inhaler body.
- the permeable sheet may be formed by a nonwoven fabric, a woven fabric, or a mesh.
- the sheet has pores with diameters within the range of 60pm - 80pm.
- the distance from the conduit to the sheet is 4.2 mm.
- the sheet is adapted to flex by means of the pressure of a flow of compound aerosol from the conduit.
- the outlet chamber 208 is formed downstream of the sheet 206.
- the outlet chamber 208 is formed downstream of the conduit 203.
- the compound may be mixed with an additive.
- the container may be pressurized.
- the pressure in the container may be 4-8 bar, e.g. around 6 bar, i.e. 600,000 Pa.
- the additive may be in a liquid state in the container.
- the compound may move into a droplet state in the expansion chamber, mixed with the additive in a gaseous form.
- the droplets may have a size (diameter) of e.g. 100-200 pm.
- the volume of the expansion chamber is preferable large enough to promote a high expansion of the compound, but small enough to not reduce the velocity of the liquid too much. If the compound velocity is too small, the droplet breaking effect of the conduit will be absent, or too low.
- the expansion chamber 201 presents an area, in a cross-section which is perpendicular to the conduit longitudinal direction, which is larger than a transverse cross-sectional area of the conduit 203.
- the expansion chamber narrows gradually towards the conduit.
- the inhaler body forms a turbulence generating surface 225 at an entrance of the conduit.
- the entrance of the conduit is formed where the compound enters the conduit.
- the turbulence generating surface forms a limitation of the expansion chamber.
- the turbulence generating surface 225 circumvents the entrance of the conduit 203.
- the turbulence generating surface forms an angle to the conduit transverse direction which 0 degrees; i.e. the turbulence generating surface extends in this example in the conduit transverse direction. Thereby, there is at the inlet of the conduit, a step in the transverse cross-sectional area of the passage.
- the turbulence generating surface promotes a compound droplet size reduction at the conduit.
- the inhaler body forms the conduit 203 by four circumferentially distributed ridges 211 extending in the conduit longitudinal direction, and towards a centerline CLC of the conduit. Thereby, the inhaler body forms the conduit such that the conduit presents a center CLC and four legs 212 extending radially from the center.
- the cross-section of the conduit is in the shape of a cross. Thereby, in a transverse crosssection of the conduit, the ratio of the square of the conduit perimeter length and the cross- sectional area of the conduit is higher than that of a circle.
- the conduit has a maximum transverse dimension TD of 0.35 mm.
- the radial extension RE of any of the legs 212 formed by the conduit, in a transverse cross-section of the conduit, is in this example 0.1 mm.
- the lateral extension LE of any of the legs formed by the conduit, in a transverse cross-section of the conduit is in this example 0.12 mm.
- a radial distance RD from a top of any of the ridges to a bottom of the respective ridge is in this example 0.15 mm.
- a distance DAT between tops of two adjacent ones of any of the ridges is in this example 0.15 mm.
- the conduit 203 in this example has a length LC in the longitudinal direction of 0.65 mm.
- the conduit body presents an outlet surface 213.
- the outlet surface 213 is angled so as to face partly in a downstream direction of the conduit, and partly radially outwardly in relation to the conduit.
- the outlet surface 213 forms an angle with a transverse direction of the conduit of 30 degrees.
- the outlet surface forms a limitation of the transport chamber 205 at an upstream end of the transport chamber.
- the transport chamber has a circular cross-section transverse to the conduit longitudinal direction.
- a transport chamber surface 2051 extends from the angled outlet surface 213 to the permeable sheet 206. Starting from the angled outlet surface, the transport chamber surface 2051 extends in parallel with the conduit longitudinal direction. Closer to the sheet 206, the transport chamber surface 2051 extends partly outwardly, so as to widen the transport chamber.
- the transport chamber has a width WT, in any direction which is transverse to the conduit, of about 5.0 mm.
- a turbulent flow forming at the outlet 2131 of the conduit 203 may also have a tendency to expand in the upstream direction, transversely outside of the conduit outlet.
- the backwards angle of the outlet surface 213 allows this upstream expansion, without disturbing it.
- the transport chamber surface 2051 is sufficiently far from the conduit outlet to not disturb the formation of the turbulence. This enhances the turbulence formation at the conduit outlet. This further facilitates the breaking up of the compound droplets.
- a row of twenty-eight ventilation openings 214 are formed in the mouthpiece 207 of the outlet chamber. As can be seen in fig. 3, the ventilation openings 214 are formed at an end of the outlet chamber 208 which is opposite to the outlet opening 204. The ventilation openings are at a distance transversely to a centerline CLO of the outlet chamber. Further, the ventilation openings are distributed circumferentially around the outlet chamber centerline CLO.
- the mouthpiece 207 comprises a longitudinal wall portion 2071 which extends mainly around the outlet chamber 208 and along the centerline CLO of the outlet chamber.
- Outlets 2141 of the ventilation openings 214 are provided in an interior ventilation surface 2142 of the envelop.
- the ventilation openings 214 are, in a transverse direction in relation to the outlet chamber centerline CLO, located outside of the sheet.
- the outlets 2141 of the ventilation openings 214 are located closer to the longitudinal wall portion 2071 than to the centerline CLO of the outlet chamber 208.
- the ventilation surface is facing in a direction along the centerline CLO of the outlet chamber.
- the ventilation surface 2142 of the mouthpiece 207 is provided on an end portion 2072 of the mouthpiece, which is located at an end of the mouthpiece which is opposite to the end presenting the outlet opening 204.
- the ventilation openings 214 are arranged to direct respective ventilation flows from the exterior of the mouthpiece into the outlet chamber.
- the orientations of the ventilation openings are such that the ventilation flows through the ventilation openings are parallel with the centerline CLO of the outlet chamber.
- the ventilation openings are cylindrical. They each have a diameter of 1.0 mm. Centerlines of the cylinders formed by the openings are parallel with the outlet chamber centerline CLO.
- the extension, along the row of ventilation openings 214, of material 2075 of the mouthpiece 207 between any two of the ventilation openings is about 2% of the length of the row of ventilation openings 214.
- a ratio of the extension of the ventilation openings 214 along the row of ventilation openings, and the extension, along the row of ventilation openings, of material 2075 of the mouthpiece 207 between the ventilation openings, is about 1.0.
- a combination of the ventilation flows surrounds the flow of the compound through the outlet chamber.
- the ventilation flows form a wall of air WO A in the outlet chamber.
- a boundary BMC of a mist of the compound extends from the permeable sheet 206 to the wall of air WOA.
- the wall of air prevents the compound mist to expand further.
- the compound mist and the wall of air may mix as the mist moves into the mouth of the user. This mix is illustrated as vortexes MV along the wall of air. As suggested, this provides a beneficial shape of the plume in the mouth, providing for a dependable delivery of the compound to the throat and lungs of the user.
- the ventilation openings 214 are elongate and extend along the row of openings.
- the width of the ventilation openings may be about 0.5 mm.
- the ventilation openings 214 are angled so as to guide the flows of air partly towards the outlet opening 204, and partly inwards in the outlet chamber 208. Thereby, the outlets 2141 of the ventilation openings 214 are located on an interior surface 2072 of the longitudinal wall portion 2071.
- inventive concept is applicable to devices other than an inhaler body for an inhaler for administering a substance to a person.
- the inventive concept may be used as follows, optionally with embodiments as disclosed herein:
- a nozzle for fire-fighting wherein the nozzle forms a passage adapted to guide water to an outlet opening of the nozzle, wherein the passage comprises a conduit, wherein the conduit is adapted to guide the water, in a longitudinal direction of the conduit, towards the outlet opening of the nozzle, wherein, in a transverse cross-section of the conduit, the ratio of the square of the conduit perimeter length and the cross-sectional area of the conduit is higher than 4 times by TI.
- the conduit may serve to reduce the droplet size on the water spray produce by the nozzle.
- the nozzle may be provided with any feature, e.g. of the conduit, of embodiments of the inhaler body described herein.
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Abstract
L'invention porte sur un corps d'inhalateur (2) pour un inhalateur destiné à administrer une substance à une personne, le corps d'inhalateur formant un passage (201, 203, 205, 208), le passage ayant une aire de section transversale qui varie le long du passage, le passage comprenant un conduit (203) qui forme la partie la plus étroite du passage. Dans une section transversale du conduit, le rapport du carré de la longueur de périmètre de conduit et de l'aire de section transversale du conduit est supérieur à 4 fois π, le corps d'inhalateur comprenant un corps (202) de conduit, et le conduit (203) étant formé dans le corps de conduit. Au niveau d'une sortie du conduit, le corps de conduit présente une surface de sortie (213) qui est inclinée de sorte à faire face en partie à une direction aval du conduit, et en partie radialement vers l'extérieur par rapport au conduit.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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SE2150102-8 | 2021-01-28 | ||
SE2150102 | 2021-01-28 |
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WO2022161937A1 true WO2022161937A1 (fr) | 2022-08-04 |
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Application Number | Title | Priority Date | Filing Date |
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PCT/EP2022/051601 WO2022161937A1 (fr) | 2021-01-28 | 2022-01-25 | Corps d'inhalateur formant un passage |
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WO (1) | WO2022161937A1 (fr) |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2001058508A2 (fr) * | 2000-02-09 | 2001-08-16 | Glaxo Group Limited | Buse d'actionneur pour aerosol-doseur |
US20070175469A1 (en) | 2005-12-02 | 2007-08-02 | Boehringer Ingelheim International Gmbh, | Dispensing device |
US20080203193A1 (en) * | 2007-02-28 | 2008-08-28 | Abbott Laboratories | Nozzle-based atomization system |
WO2009095160A1 (fr) * | 2008-01-30 | 2009-08-06 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Buse et inhalateur et procédé de production de buse |
US20100059050A1 (en) | 2006-04-11 | 2010-03-11 | Herbert Wachtel | Mouthpiece for an inhaler |
DE202017005165U1 (de) * | 2017-10-06 | 2017-10-18 | WERRTA GmbH Düsen- und Zerstäubungstechnik | Düsenkörper |
-
2022
- 2022-01-25 WO PCT/EP2022/051601 patent/WO2022161937A1/fr active Application Filing
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2001058508A2 (fr) * | 2000-02-09 | 2001-08-16 | Glaxo Group Limited | Buse d'actionneur pour aerosol-doseur |
US20070175469A1 (en) | 2005-12-02 | 2007-08-02 | Boehringer Ingelheim International Gmbh, | Dispensing device |
US20100059050A1 (en) | 2006-04-11 | 2010-03-11 | Herbert Wachtel | Mouthpiece for an inhaler |
US20080203193A1 (en) * | 2007-02-28 | 2008-08-28 | Abbott Laboratories | Nozzle-based atomization system |
WO2009095160A1 (fr) * | 2008-01-30 | 2009-08-06 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Buse et inhalateur et procédé de production de buse |
DE202017005165U1 (de) * | 2017-10-06 | 2017-10-18 | WERRTA GmbH Düsen- und Zerstäubungstechnik | Düsenkörper |
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