WO2010076012A1 - Composant et inhalateur ainsi que procédé de fabrication d'un composant - Google Patents

Composant et inhalateur ainsi que procédé de fabrication d'un composant Download PDF

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Publication number
WO2010076012A1
WO2010076012A1 PCT/EP2009/009290 EP2009009290W WO2010076012A1 WO 2010076012 A1 WO2010076012 A1 WO 2010076012A1 EP 2009009290 W EP2009009290 W EP 2009009290W WO 2010076012 A1 WO2010076012 A1 WO 2010076012A1
Authority
WO
WIPO (PCT)
Prior art keywords
component
amino
fluid
nozzle opening
nozzle
Prior art date
Application number
PCT/EP2009/009290
Other languages
German (de)
English (en)
Inventor
Matthias Hausmann
Waldemar Masur
Hartmut Walcher
Original Assignee
Boehringer Ingelheim International Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boehringer Ingelheim International Gmbh filed Critical Boehringer Ingelheim International Gmbh
Publication of WO2010076012A1 publication Critical patent/WO2010076012A1/fr

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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
    • 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
    • B05B1/3421—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 with channels emerging substantially tangentially in the swirl chamber
    • B05B1/3431—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 with channels emerging substantially tangentially in the swirl chamber the channels being formed at the interface of cooperating elements, e.g. by means of grooves
    • B05B1/3436—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 with channels emerging substantially tangentially in the swirl chamber the channels being formed at the interface of cooperating elements, e.g. by means of grooves the interface being a plane perpendicular to the outlet axis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B15/00—Details of spraying plant or spraying apparatus not otherwise provided for; Accessories
    • B05B15/40—Filters located upstream of the spraying outlets
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
    • B22F3/22—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces for producing castings from a slip
    • B22F3/225—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces for producing castings from a slip by injection molding
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
    • B22F5/00—Manufacture of workpieces or articles from metallic powder characterised by the special shape of the product
    • B22F5/10—Manufacture of workpieces or articles from metallic powder characterised by the special shape of the product of articles with cavities or holes, not otherwise provided for in the preceding subgroups
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B28—WORKING CEMENT, CLAY, OR STONE
    • B28B—SHAPING CLAY OR OTHER CERAMIC COMPOSITIONS; SHAPING SLAG; SHAPING MIXTURES CONTAINING CEMENTITIOUS MATERIAL, e.g. PLASTER
    • B28B1/00—Producing shaped prefabricated articles from the material
    • B28B1/24—Producing shaped prefabricated articles from the material by injection moulding
    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B35/00—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
    • C04B35/01—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics
    • C04B35/10—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on aluminium oxide
    • C04B35/111—Fine ceramics
    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B35/00—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
    • C04B35/01—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics
    • C04B35/48—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on zirconium or hafnium oxides, zirconates, zircon or hafnates
    • C04B35/49—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on zirconium or hafnium oxides, zirconates, zircon or hafnates containing also titanium oxides or titanates
    • C04B35/491—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on zirconium or hafnium oxides, zirconates, zircon or hafnates containing also titanium oxides or titanates based on lead zirconates and lead titanates, e.g. PZT
    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B35/00—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
    • C04B35/515—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on non-oxide ceramics
    • C04B35/56—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on non-oxide ceramics based on carbides or oxycarbides
    • C04B35/565—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on non-oxide ceramics based on carbides or oxycarbides based on silicon carbide
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
    • B05B11/10—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle
    • B05B11/1001—Piston pumps
    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B2235/00—Aspects relating to ceramic starting mixtures or sintered ceramic products
    • C04B2235/60—Aspects relating to the preparation, properties or mechanical treatment of green bodies or pre-forms
    • C04B2235/602—Making the green bodies or pre-forms by moulding
    • C04B2235/6027—Slip casting

Definitions

  • the present invention relates to a component for dispensing, in particular sputtering, a fluid, particularly preferably, a liquid or pharmaceutical preparation, according to the preamble of claim 1, an inhaler for atomizing a fluid according to the preamble of claim 8 or 9 and to methods for producing a in particular, such a component.
  • a quantity of active substance as precisely defined as possible should be converted into an aerosol for inhalation.
  • the aerosol should be characterized by a small mean droplet size with a narrow droplet size distribution and by a low pulse (low propagation velocity).
  • drug formulation in the present invention also refers to therapeutics or the like, in particular to any type of inhalation or other use agent.
  • the present invention is not limited to the atomization of inhalation agents, but may be used for other purposes, although the following description is directed primarily to the preferred atomization of a drug formulation for inhalation.
  • liquid or “liquid” is to be understood in a broad sense and in particular also includes dispersions, suspensions and so-called suspensions (mixtures of solutions and suspensions) or the like.
  • suspension mixture of solutions and suspensions
  • fluid is primarily referred to below, although preferably a liquid is used.
  • anosol in the present invention is meant a preferably cloud-like accumulation of a plurality of droplets of atomized fluid having preferably substantially unregulated or wide spatial distribution of the directions of movement and preferably low velocities of the droplets, but may also be an example conical or radial droplet cloud with
  • BESTATIGUNGSKOPIE a main direction corresponding to the main exit direction or exit pulse direction.
  • WO 2007/101557 A2 discloses the production of a vortex nozzle from two superimposed plate-shaped pieces of material and an inhaler provided with the vortex nozzle. Again, the production and construction are relatively expensive. Furthermore, the vortex nozzle must be sealed and assembled with a pump or a pressure generator of the inhaler. This is also expensive.
  • the powder casting (Powder Injection Molding, called "PIM”) is known.
  • the process consists essentially of the four steps of molding material preparation, molding by injection molding, removal of a binder and sintering.
  • a metal or ceramic powder is produced by displacement with a mostly polymeric binder, a molding compound, a so-called feedstock.
  • the molding compound can then be processed on an injection molding machine, whereby a molded part, the so-called green body, is produced.
  • the green compact is debinded in a special oven, that is, the binder is removed thermally or degradatively.
  • the remaining powder framework is then sintered in a high-temperature furnace to the actual component.
  • PIM technology is generally to be understood as meaning a powder injection molding process, with particular subsequent sintering of the component, and particularly preferably a method as described above.
  • the present invention When a metal powder is used as the base or starting material for the feedstock, the present invention is also referred to as MIM (Metal Injection Molding) or MIM technology.
  • MIM Metal Injection Molding
  • CIM Ceramic Injection Molding
  • the PIM technology has not heretofore been used in the manufacture of inhaler components in contact with a drug formulation. This may be due to the requirements with regard to metering accuracy, sterility or the like in medical inhalers or in the atomizer of pharmaceutical formulations.
  • the present invention has for its object to provide a component for dispensing, in particular atomization, of a fluid, an inhaler for atomizing a fluid and method for producing a component, wherein a simple and / or cost-effective production, in particular of components with microstructures is possible ,
  • One aspect of the present invention is to produce the component for dispensing, in particular atomization, of a fluid in one piece and at least essentially in PIM technology. This allows a simple and cost-effective production, in particular if the component has a nozzle opening, a preferably radial fluid inlet, a preferably radial vortex chamber, a filter and / or a pumping space for the fluid. This allows a simple and / or cost-effective production.
  • a einstü kiges component which forms a nozzle opening and at least partially a pump space.
  • the component is preferably installed in an inhaler, a high-pressure pump or the like or forms a high-pressure pump, in particular for a medical fluid or device, such as an inhaler. This allows a simple and / or cost-effective production.
  • an inhaler for atomizing a fluid wherein a fluid-conducting component is made at least substantially in PIM technology. This allows a simple and / or cost-effective production.
  • a method for producing a one-piece component wherein both microstructures and macrostructures of the component are produced at least substantially or exclusively in PIM technology.
  • the microstructures preferably form a nozzle orifice, a fluid inlet, a vortex chamber and / or a filter.
  • the macrostructures preferably form a pumping space, a holding element for holding or fastening the component and / or a receptacle for an inside cover of a nozzle opening of the component or an associated nozzle. This allows a simple and / or cost-effective production.
  • a method for producing a component wherein the component is produced at least substantially or exclusively in PIM technology in a casting mold, which itself consists of sintered material or is produced in PIM technology, in particular to reduce molded microstructures by shrinkage.
  • a casting mold which itself consists of sintered material or is produced in PIM technology, in particular to reduce molded microstructures by shrinkage.
  • a method for producing a component with a nozzle opening is proposed, wherein the component is produced at least substantially or exclusively in PIM technology, wherein a molding for at least partially forming the Düsenöffhung is poured, wherein the molding before , is removed at or after sintering or by sintering.
  • the molded piece is in particular a lost part, which is preferably removed only during sintering or thereafter, for example by etching. This allows a simple and / or cost-effective production, in particular also of fine nozzle openings.
  • a method of manufacturing a component having a nozzle opening is proposed, wherein the component is made at least substantially or exclusively in PIM technology, wherein the nozzle opening is formed or opened by laser ablation or laser drilling of the already sintered component.
  • no mechanical post-processing then takes place. This allows a simple and / or cost-effective production.
  • a method for producing a component with a nozzle opening, wherein the component is at least substantially or exclusively in PIM
  • FIG. 1 shows a schematic section of a proposed inhaler in the untensioned state.
  • FIG. 2 shows a schematic section of the inhaler in the tensioned state rotated by 90 ° with respect to FIG. 1;
  • FIG. 3 is a fragmentary, enlarged section of a nozzle of the inhaler according to Figures 1 and 2.
  • Fig. 4 is a section of Figure 3 taken along line IV-IV;
  • 5 is a sectional view of a pump or an inhaler according to another embodiment
  • 6 shows a schematic section of a reservoir for the inhaler according to a further embodiment
  • FIG. 7 shows a perspective, partially cutaway illustration of a component of the reservoir according to FIG. 6.
  • Fig. 8 is a schematic section when casting a component.
  • FIG. 1 and 2 show a proposed inhaler 1 for the atomization of a fluid 2, in particular a liquid or pharmaceutical preparation, in a schematic representation in the unstressed state (FIG. 1) and in the tensioned state (FIG. 2).
  • the inhaler 1 is designed in particular as a portable inhaler and / or preferably operates without propellant gas.
  • the inhaler 1 has a preferably usable and possibly exchangeable reservoir 3 with the fluid 2, as shown in FIGS. 1 and 2.
  • the reservoir 3 contains a sufficient amount (typically 2 to 10 or 2 to 15 ml) of fluid 2 or drug for multiple doses, so as to allow multiple atomizations or applications.
  • the reservoir 3 is preferably substantially cylindrical or cartouche-like and / or designed as a particularly rigid container and / or, for example, from below, after opening the inhaler 1, inserted into this and optionally interchangeable.
  • the reservoir 3 has a fluid space 4, preferably designed as a bag or formed thereby, with the fluid 2.
  • the fluid space 4 or a wall bounding the fluid space is preferably-at least regionally-flexible, deformable and / or collapsible.
  • the inhaler 1 preferably has a conveying device, preferably a pump, in particular a high-pressure and / or metering pump or a Pressure generator 5, for the promotion and / or atomization of the fluid 2, in particular in each case in a predetermined, optionally adjustable dosing.
  • a conveying device preferably a pump, in particular a high-pressure and / or metering pump or a Pressure generator 5, for the promotion and / or atomization of the fluid 2, in particular in each case in a predetermined, optionally adjustable dosing.
  • the inhaler 1 or pressure generator 5 has a holder 6 for the reservoir 3, an associated, only partially shown drive spring 7 preferably with an associated, manually operated for unlocking
  • Blocking element 8 a preferably designed as a capillary conveying element or conveying pipe 9, an optional valve, in particular check valve 10, a pump or pressure chamber 11 (FIG. 2) and / or a nozzle 12 on.
  • the nozzle 12 preferably serves for the direct discharge or atomization of the fluid 2, opens directly into the open air and / or is arranged in particular in the region of a mouthpiece 13 or other end piece of the inhaler 1.
  • the reservoir 3 is so fixed in the inhaler 1 via the holder 6, in particular by clamping or rastend, that the conveying element is immersed in the fluid space 4 and / or fluidly connected thereto.
  • the holder 6 can be designed such that the reservoir 3 can be replaced.
  • the holder 6 with the reservoir 3 and the delivery element is moved downwards in the representations and the fluid 2 - more precisely the next dose - from the reservoir 3 via the check valve 10 into the pressure chamber 11 of the pressure generator 5 sucked.
  • the fluid space 4 (bag) collapses in response to the removal of fluid 2.
  • the fluid 2 in the pressure chamber 11 is pressurized by the delivery element being moved upwards now, with the check valve 10 now closed, solely by the force of the drive spring 7, and now acts as a plunger. This pressure expels the fluid 2 through the nozzle 12, where it is atomized.
  • respirable aerosol 14 (FIG. 1), which may be received, in particular inhaled or inhaled, by a user or patient (not shown).
  • inhalation takes place at least once a day, in particular several times a day, wise at predetermined intervals, in particular depending on the disease of the patient.
  • supply air can be sucked into the mouthpiece 13 via at least one supply air opening 15.
  • the reservoir 3 is moved back by the drive spring 7 back to its original position.
  • the reservoir 3 thus preferably performs a lifting movement during the tensioning process and during the atomization process.
  • the inhaler 1 has a first housing part (upper part) 16 and a rotatable inner part 17 (FIG. 2) with an upper part 17a and a lower part 17b (FIG. 1), wherein on the inner part 17 there is an especially manually operable or rotatable, second housing part (lower part) 18 preferably by means of a security fastener or holding element 19 releasably secured, in particular attached thereto, is.
  • the safety closure or the holding element 19 is designed such that accidental opening of the inhaler 1 or removal of the second housing part 18 is excluded.
  • the retaining element 19 must be pressed against spring force.
  • the second housing part 18 is detachable from the inhaler 1.
  • the second housing part 18 preferably forms a cap-like housing lower part and / or encompasses or engages over a lower free end region of the reservoir 3.
  • the second housing part 18 can be rotated relative to the first housing part 16, wherein the inner part 17 is rotated.
  • the drive spring 7 is tensioned in the axial direction via a gear not shown in detail, acting on the holder 6.
  • the holder 6 or the reservoir 3 With the clamping, the holder 6 or the reservoir 3 becomes axially downwards or with its end region (farther) into the second housing part 18 or towards its end-face end moves until the reservoir 3 occupies an indicated in Fig. 2 end position. In this state, the drive spring 7 is tensioned.
  • the inhaler 1 preferably has a device for forcibly aerating the reservoir 3, in particular an optional outer shell 23 of the reservoir 3.
  • a piercing or opening of the outer sheath 23 takes place as required or optionally.
  • an axially acting spring 20 arranged in the housing part 18 comes into contact with the bottom 21 of the reservoir 3, which bears the outer sheath with a piercing element 22 23 or a bottom-side, in particular gas-tight seal at the first plant for ventilation abuts.
  • the means for forced ventilation is thus formed here by the piercing element 22, which is held or formed by the spring 20.
  • the piercing element 22 which is held or formed by the spring 20.
  • the flexible or deformable bag or fluid space 4 collapses.
  • the ambient air can flow into the reservoir 3 or the outer casing 23 via the ventilation or piercing opening.
  • the forced ventilation device is optional.
  • the device for forced ventilation can be omitted altogether, for example if the outer shell 23 of the reservoir 3 is anyway not at least substantially gas-tight and / or if another device, such as a valve, is provided for ventilation.
  • the reservoir 3 To use the inhaler 1, the reservoir 3 must first be used. This preferably takes place in that the second housing part 18 is removed or withdrawn. Subsequently, the reservoir 3 is inserted or inserted axially into the inner part 17. This is a head-side Opening or connecting. This is done by the conveying element, so here the delivery pipe 9, which pierces a preferably provided, in particular end or head seal of the reservoir 3 and / or then by a particular head-side closure 24, preferably with a septum into the interior of the reservoir 3 and Fluid space 4 is introduced.
  • the delivery pipe 9 which pierces a preferably provided, in particular end or head seal of the reservoir 3 and / or then by a particular head-side closure 24, preferably with a septum into the interior of the reservoir 3 and Fluid space 4 is introduced.
  • the second housing part 18 is placed again or pushed. Now the first time tensioning of the inhaler 1 can take place.
  • the reservoir 3 is then pierced on the bottom side by the piercing element 22, that is, forcibly ventilated, as already explained.
  • the inhaler 1 Before the first use after insertion or fluidic connection of the reservoir 3, preferably a repeated clamping and triggering of the inhaler 1. This so-called priming is displaced in the conveying element and / or in the pressure generator 5 to the nozzle 12 possibly existing air from the fluid 2 , Subsequently, the inhaler 1 is ready for dispensing or inhalation.
  • the inhaler 1 preferably has a component 25, which is particularly preferably produced at least substantially or exclusively in PIM technology.
  • the component 25 serves in particular for the conduction or guidance and / or atomization of the fluid 2.
  • the component 25 particularly preferably forms the nozzle 12 or at least a substantial part of the nozzle 12.
  • FIG. 3 shows in a schematic, fragmentary section of FIGS. 1 and 2 the component 25 or the nozzle 12 in an enlarged representation.
  • the component 25 is preferably formed in one piece and / or cast in one piece.
  • the component 25 is preferably pot-shaped or container-shaped towards the fluid or pump chamber 11.
  • the component 25 preferably has a nozzle opening 26.
  • the nozzle opening 26 is preferably formed in an axial or end wall 27 of the component 25, in a bottom of the component 25 or the like.
  • the component 25 preferably has or forms a fluid inlet 28 for the nozzle opening 26.
  • the fluid inlet 28 extends radially and / or transversely to the preferably axially extending nozzle opening 26.
  • the component 25 has a vortex chamber 29 upstream of the nozzle opening 26 or forms it.
  • the component 25 preferably has or forms a filter 30 for the fluid 2.
  • the filter 30 is preferably arranged in a (radial) plane with the fluid inlet 28 and / or the vortex chamber 29.
  • the component 25 preferably forms at least partially the wall of the pumping space or the pressure chamber 11, as shown in FIG.
  • the pump chamber 11 is preferably formed as a hollow cylinder or pot-shaped.
  • the end wall 27 preferably forms at least part of a bottom of the pump space 11 or of the component 25.
  • the component 25 preferably forms a receiving area 31 for receiving a cover 32, such as a nozzle plug, for the inside cover of the Düsenöffiiung 26, the vortex chamber 29, the fluid inlet 28 and / or the filter 30.
  • the receiving portion 31 is preferably formed in a hollow cylinder or pot-like and / or preferably has an at least slightly smaller diameter than the adjoining pump chamber 11.
  • the end wall 27 forms with the nozzle opening 26, a bottom or axial termination of Aufhahme Suites 31.
  • the cover 32 is particularly preferably cylindrical or plug-like design and / or received or held by clamping in the Aufhahme Geb 31.
  • other constructive solutions are possible here.
  • the cover 32 preferably has at least one here in particular axially extending channel 33 for the fluid 2, as indicated in Figure 3, to To connect the pumping space 11 fluidly with the nozzle 12 and the filter 30 or fluid supply 28 or the vortex chamber 29.
  • FIG. 4 shows a section of the component 25 along line IV-IV according to FIG. 3 or a view from the inside onto the end wall 27 without cover 32.
  • the optional filter 30 is preferably arranged upstream of the fluid inlet 28, the optional filter 30 is preferably arranged.
  • the filter 30 is preferably formed in the illustrated example by a plurality of small, very closely spaced elevations 34, which are distributed in particular over a circumference at a small distance from each other.
  • the projections 34 protrude in the axial direction of the end wall 27 and preferably extend substantially to the cover 32.
  • the filter 30 is designed so that the fluid 2 between the elevations 34 and / or must flow across them to in to get the fluid inlet 28. Accordingly, the filter 30 can filter out particles from the fluid 2, which could otherwise clog the channels of the fluid inlet 28 which preferably flow toward the nozzle opening 26 or the swirl chamber 29.
  • the filter elements or elevations 34 are arranged here between an inner annular channel 35 and an outer annular channel 36.
  • the inner annular channel 35 is connected via the fluid inlet 28 to the swirl chamber 29 or Düsenöffhung 26.
  • the outer annular channel 36 is fluidly connected here via the channel 33 to the pumping chamber (pressure chamber 11).
  • the filter 30 is provided only optional, so if necessary, can also be omitted.
  • a pre-filter may also be connected upstream.
  • the fluid inlet 28 is preferably formed by a plurality of channels, at least two substantially tangential and / or radial and / or tapering towards the nozzle opening 26 or the vortex chamber 29.
  • the channels forming the fluid inlet 28 open radially. is located to Düsenöffiiung 26 in the vortex chamber 29, which accordingly has a preferably larger diameter than the Düsenöffiiung 26 and / or extends radially.
  • the swirl chamber 29 may also have at least substantially the same diameter as the nozzle opening 26, which adjoins in particular axially or transversely, and / or the fluid inlet 28 may open directly into the nozzle opening 26.
  • the nozzle 12 forms a "vortex nozzle" instead of a "vortex chamber nozzle".
  • structures or channel geometries as shown in WO 2007/101557 A2, can be realized.
  • the fluid inlet 28 is preferably limited by elevated areas 37 and the end wall 27.
  • the channels forming the fluid inlet 28, leading to the nozzle opening 26 or swirl chamber 29, are formed between the raised areas 37.
  • other constructive solutions are possible.
  • the component 25 at least substantially forms the nozzle 12 or has these.
  • the nozzle 12 preferably has the filter 30, the fluid inlet 28 and / or the vortex chamber 29 beyond the nozzle opening 26.
  • the nozzle 12 is designed here in particular as a vortex or vortex chamber nozzle.
  • the nozzle opening 26 is designed in particular as an at least substantially cylindrical opening of the end wall 27.
  • the nozzle opening 26 preferably ends directly outside.
  • a further beam shaping or other atomizing device is preferably not provided.
  • nozzle opening 26 it is also possible to provide a plurality of nozzle openings 26, if appropriate also a plurality of nozzles 12, in particular vortex nozzles, as disclosed for example in FIG. 4 of WO 2007/101557 A2.
  • the nozzle orifices 26 are then preferably oriented so that the exiting fluid jets intersect to achieve a finer atomization and / or slowing of the aerosol 14.
  • the nozzle opening 26 preferably has an at least substantially constant diameter over the length of the nozzle opening 26.
  • the nozzle opening 26 can also be widened or formed in particular conically or funnel-shaped on the inlet side and / or outlet side.
  • the (narrowest or average) diameter of the nozzle opening 26 is preferably 10 to 200 .mu.m, in particular 20 to 80 .mu.m, most preferably 25 to 45 microns.
  • the nozzle orifice 26 is preferably formed to be substantially cylindrical and / or at least circular in the region of the narrowest cross section.
  • the nozzle opening 26 can also be designed basically funnel-shaped or at least partially funnel-shaped. Also in this case, however, it preferably has an area with a preferably substantially round cross-section.
  • the length of the nozzle opening 26 is about 0.5 to 2 times the diameter of the Düsenöffhung 26 in the region of its narrowest cross section.
  • the length of the nozzle opening 26 preferably corresponds at least substantially to the thickness of the end wall 27.
  • the length is preferably about 30 to 200 .mu.m, in particular about 40 to 150 .mu.m, more preferably about 50 to 90 microns.
  • the component 5 has microstructures in the illustrated example. These are preferably formed by the filter 30, the fluid inlet 28, the swirl chamber 29 and / or the nozzle opening (s) 26.
  • the microstructures of the component 25 preferably form the nozzle 12, in particular a spray nozzle and / or vortex nozzle or vortex chamber nozzle.
  • the microstructures preferably have structure depths and / or widths in the size range between 1 and 200 ⁇ m, in particular approximately 5 to 120 ⁇ m.
  • the microstructures are preferably formed by the end wall 27 or another wall, which in particular have a layer thickness of about 25 to 200 .mu.m, more preferably about 25 to 100 .mu.m.
  • the maximum or average texture depth and / or width of the microstructures is preferably about 10 to 30%, most preferably substantially 20%, of the aforementioned layer thickness.
  • the fluid inlet 28 preferably channels having structure widths between 10 to 120 .mu.m, in particular between 80 to 100 microns.
  • the structure depths are preferably between 5 and 35 ⁇ m.
  • the structure depth or height (for example, the height of the elevations 34 and / or the raised areas 37) is preferably substantially 5 to 20 .mu.m, more preferably about 10 to 15 .mu.m.
  • the microstructures are preferably formed on the bottom side and / or axially on the component 25 or formed.
  • the component 25 preferably also has macrostructures in addition to the mentioned microstructures, which are distinguished in particular by feature sizes of less than 200 ⁇ m.
  • macrostructures are here preferably elements or regions with feature sizes of more than 500 microns to understand.
  • the macrostructures preferably have a dimensional accuracy which is substantially below this limit and in particular corresponds at least substantially to the molding tolerances of the microstructures.
  • the macrostructures preferably include the pumping space and the pressure chamber 11, respectively.
  • the macrostructures are preferably characterized by a radial shaping in contrast to the axial shaping of the microstructures.
  • the macrostructures are preferably characterized by an outer-side design, in contrast to the preferred inner-side design of the microstructures.
  • the macrostructures may also have the elements exemplified below, wherein the macrostructures are preferably formed integrally with the microstructures or formed by or in the one-piece component 25.
  • the component 25 preferably has a projecting and / or peripheral edge 38, which forms a macrostructure in the aforementioned sense, for protecting the nozzle 12 or nozzle opening 26 and / or for other purposes, for example for guiding an air flow.
  • the edge 38 is preferably integrally formed.
  • the component 25 preferably has at least one in particular integrally molded holding element 39, as indicated in Figures 1 and 2.
  • the holding element 39 serves for holding, fastening, supporting or guiding the component 25 in the inhaler 1 and forms a macrostructure in the aforementioned sense.
  • the holding element 39 is preferably circumferential, annular or flange-like or formed as a lateral projection and / or arranged on the outside in the illustrated example.
  • the macrostructures in their relevant dimensions are preferably at least a factor of 10, in particular by a factor of 20, 100, 1000 or more, larger than the microstructures.
  • the macrostructures are particularly preferably formed by radial shaping and / or on the outside of the component 25.
  • axial and radial refer preferably to the Entformungscardi of the component 25 during injection molding, especially in the production in PIM technology, on the direction of movement of the conveying element, here the conveyor pipe 9, and / or on the Hauptaustrags- direction of the nozzle 12 and the longitudinal extension of the Düsenöffhung 26th
  • the component 25 is preferably at least substantially rotationally symmetrical in the axial direction.
  • the nozzle opening 26 is preferably in this main axis. Due to the preferred one-piece design of the component 25, the nozzle opening 26, on the one hand, and the fluid inlet 28 and / or filter 30, on the other hand, are preferably fluid-tightly connected to one another and / or correspondingly integrally formed without sealing.
  • the component 25 preferably forms a pump, in particular a high-pressure pump or a central part thereof, and / or an inhaler nozzle, in particular wherein a conveying element, such as the conveying tube 9, a piston or the like, is inserted or engaged in the pumping space 11.
  • a conveying element such as the conveying tube 9, a piston or the like
  • FIG. 5 shows, in a sectioned enlarged section, another embodiment of a pump or a central part of the inhaler 1-forming component 25.
  • the component 25 preferably has a reinforcing element 40, which is injected or cast in particular at least partially into the component 25.
  • the reinforcing element 40 is preferably made of a different material, such as metal or plastic, but may also be made in PIM technology.
  • the reinforcing element 40 is completely molded into the component 25 in the illustration example.
  • the reinforcing element 40 can also protrude from the component 25, for example to form a holding element 39 in the aforementioned sense, in particular for holding the component 25 and / or connection of the component 25.
  • the reinforcing element 40 may additionally form or limit a surface and / or wall of the component 25, for example the pump chamber 11, an outer surface, a stop and / or the like.
  • the reinforcing element 40 is preferably formed annular or hollow cylindrical. Its shape may vary depending on the purpose.
  • the component 25 itself is preferably partially re-injected or injected.
  • the component 25 comprises a material, preferably a plastic 41, in particular a thermoplastic or duroplastic or an elastomer, on, with which the component 25, for example, on the outside in the region of contact with the housing part 16 or another holding part for mounting the component 25 or for other purposes is encapsulated.
  • the component 25 may alternatively or additionally be installed, attached and / or held in any other way.
  • the component 25 is held or secured by means of a spring lock 42 on or in the housing part 16 or other holding part, in particular in such a way that the component 25 only has to be inserted and automatically or automatically by the Federverrastung 42nd is secured.
  • the component 25 or its holding element 39 a projection or stop, in particular here an undercut 43 to hold a preferably metallic spring member 44 (for example, the spring member 44 is bent or crimped so that it engages behind the undercut 43).
  • the spring member 44 has in the illustrated example on at least one abragmenting spring leg 45, the at least one shoulder 46 - in the illustration example of several annular successively and in particular diameter-increasing annular shoulders 46 - engage and / or can support to the component 25 in the desired Save manner in the housing part 16 or the like.
  • the spring member 44 may also be partially injected into the component 25 and thereby firmly connected thereto.
  • FIG. 5 further shows a preferably dynamic seal 47, preferably built into the component 25, for sealing between the pumping space 11 and the conveying element (conveying tube 9).
  • the component 25 has a receiving space for the seal 47.
  • the pumping space 1 1 is stepped and / or reduced in diameter, as required, to the nozzle opening 26 or the receiving area 31 for the cover 32, around the cover 32 after the component 25 has been produced in the receiving area 31 in particular to be able to use clamping.
  • the cover 32 and / or other elements it is also possible for the cover 32 and / or other elements to be injected directly into the component 25.
  • the nozzle 12 or the nozzle opening 26 is preferably formed directly from the component 25, which also forms the pump chamber 11.
  • static seals between the pump chamber 1 1 on the one hand and the nozzle 12 on the other hand omitted.
  • the component 25 forms a central component for the inhaler 1 or pressure generator 5 or a pump / high-pressure pump for dispensing and in particular direct atomization of the fluid 2.
  • the component 25 forms in addition to the above-mentioned micro and macrostructures preferably also the reservoir 3 for the fluid 2, in particular only for a single dose of the fluid 2.
  • FIG. 6 shows in a schematic section of the further embodiment.
  • FIG. 7 shows in a perspective, partially sectioned view the component 25 without associated housing part 16 or other holding part. And without cover 32, so that the microstructured bottom (end wall 27) is schematically visible.
  • the pump chamber 11 or the component 25 on the piston side that is sealed at the preferably on the inlet side widening insertion opening for the piston 48 or completed in most other way largely fluid and gas tight.
  • This seal or this closure is apparently before or during use, for example, pierced by an actuating element, not shown.
  • the piston 48 - for example, by the aforementioned actuating element - to the nozzle 12 and passage opening 26 toward shifted ben, so that the located in the pump chamber 11 fluid 2 is expelled via the nozzle 12 and preferably atomized directly.
  • the nozzle 12 can also be sealed on the outlet side or otherwise sealed in a fluid-tight and preferably gastight manner or covered. The opening then preferably takes place before the fluid 2 is dispensed.
  • the reservoir 3 or component 25 according to the embodiment shown in FIGS. 6 and 7 can also be used independently of the inhaler 1 as a system for applying a dose of the fluid 2.
  • the present invention comprises in particular the following basic ideas and aspects:
  • Microstructures or microstructured vortex (chamber) nozzles 12 are produced in PIM technology.
  • Injection molding processes such as the preferred PIM technology, are large-scale, mass-produced processes, so that inexpensive components 25 can be created, which can be used in particular in single-use devices.
  • a plurality of components or components and / or functions can be combined, for example, in addition to the nozzle 12 and air flow-determining components or the like. This results in more geometrical variation possibilities compared to the metal holders for nozzles or the like which are usually produced in cutting turning processes.
  • Corrosion resistant materials can be used.
  • the production of the component 25 is at least substantially made of ceramic, particularly preferably in CIM technology.
  • a particular aspect of the present invention is that injection molding based methods are proposed which allow macrostructures to combine with microstructures in the component 25.
  • the microstructures such as a vortex nozzle 12 not only with holder geometries, but also with the entire pump body, pump chamber 11 or the like, which among other things, the previously built static sealing elements can be omitted between existing components.
  • static seals storage and operating losses of the fluid volume in the individual atomization processes or doses can be minimized.
  • a core component 25 with the intended microstructures from a PIM material other than the remainder of the component, since in particular relatively expensive, fine-grained injection mixtures (feedstocks) must be used in particular for spraying microstructures in the particle size ratios can quickly pose difficulties in processability.
  • the component 25 for a high-pressure atomizing pump, only a closed-pore material is used, that is to say that the finished component 25 is sufficiently fluid-tight and gas-tight in the desired manner.
  • ceramic materials are preferably used for the production of the components 25 or of the microstructures and possibly also of the macrostructures.
  • Al 2 O 3 , SiC and barium zirconate titanate for CIM technologies are particularly suitable for this purpose.
  • the feedstock mixtures prepared from the starting materials additionally contain binders, such as polyolefins. These binders are preferably removed from the component 25 or the green compact (usually before sintering) in a temperature process step following the injection process (casting process).
  • a particular aspect of the present invention is to cascade molding and sintering process steps. Namely, in each sintering process following a PIM process step, the respective components 25 undergo some material shrinkage, for example typically 20% for Al 2 O 3 components. To produce the corresponding microstructures that are so fine that they are difficult or impossible can no longer bring in a machining tool in a molding tool, preferably a tool (a mold) for the Zielbau- part 25 also created directly from an injection-sintering process or produced in PIM technology (the corresponding original tool can this particular per Precision sink EDM in the ECM process or microzerspanung be created).
  • the lower structural limits of the PIM technology are essentially determined by the particle sizes of the feedstock mixtures for the injection molding process.
  • the mean particle sizes are in particular substantially 0.7 ⁇ m. From the mean grain size and the associated particle size variation (grain sizes of 1.5 microns are also represented) result in imaging accuracy, ie smallest possible structure sizes or depths of 5 to 10 microns (at 5-times grain size). Accordingly, the structures proposed in WO 2007/101557 A2 and particularly preferred with dimensions of 10 to 20 ⁇ m can be readily implemented or realized.
  • the microstructures can definitely be applied to a ner also thin carrier layer - like the end wall 27 - protrude or be formed in this. Only the 5- to 10-fold structural height or depth is required by injection molding technology, so that in the microstructured region minimum thicknesses of the carrier layer of 25 ⁇ m can be realized with the finest possible microstructuring.
  • the proposed methods and the PIM technology allow the production of nozzles with very high reliability and accuracy, in particular, a mass production is possible.
  • the present invention allows a nebulizer unit or an inhaler 1 to be constructed with inexpensive and, if possible, fewer individual components or components, so that the production of the overall apparatus is also cheaper and potential device weaknesses can be reduced.
  • microstructures are produced in PIM technology.
  • both macrostructures and microstructures in a component are combined or produced in an injection-molding-based method, particularly preferably in a casting step and / or sintering step and / or in the same casting mold.
  • the microstructures such as a vortex chamber nozzle, not only with particular outside and / or outlet side geometries or component sections for mounting, support, air duct or the like., As the edge 38, but also with the entire pump body (pump chamber 11) combined.
  • the high pressure pump or the nebulizer or inhaler 1 preferably comes without static seal for the nozzle 12.
  • the fluid inlet 28 and / or the vortex chamber 29 is formed.
  • WO 2007/101 557 A2 is therefore introduced as a supplementary disclosure regarding the structure and / or channel training.
  • "coarser" classical vortex chamber nozzle arrangements can also be realized, as exemplified by the above embodiments.
  • the membrane-like or very small layer thicknesses or wall thicknesses in the microstructured region (in this case the end wall 27) can already be produced directly by injection molding or in PIM technology, in particular in connection with the here desired macroscopically markedly material-thicker structures in the same component 25 Due to the preferred material reinforcement from the nozzle opening 26 toward the outside, a higher strength of the component 25 is produced, which is particularly helpful in component areas in which annular channels 35, 36 and / or the fluid inlet 28 run.
  • the local precision is also remarkable in the injection molding process. It is possible to position the microstructured region itself or the nozzle orifice 26 within the scope of 5 ⁇ m accuracy in the axial and / or radial direction.
  • a corresponding direct injection molding realization in the component 25 is not possible or desirable, depending on certain geometries, Anspritzgunen or the like, the materials and manufacturing methods used here are also very good for grinding up to a layer thickness of about 60 to 200 ⁇ m, in particular substantially to 90 to 110 ⁇ m.
  • corresponding microbores such as the nozzle opening 26, structurally mounted in the component 25 and from the opposite side depending on the requirements, for example by means of disc or ball pin grinding processes, be opened.
  • the nozzle opening 26 is mapped together with the other microstructures first by corresponding contours in a primal tool (original or template or pattern) positive.
  • the original casting Tool is used to produce an intermediate tool (an intermediate mold) by molding the master mold, especially in PIM technology, so that the intermediate mold for the later Düsenöfmung 26 forms a corresponding pin or pin or projection as a negative mold, it shrinks during sintering, so that from a smaller opening can be molded than directly from a tool, with a solid, machined pin, bolt or projection.
  • this method can only be used when creating comparatively large outlet openings, in particular with a diameter greater than 150 ⁇ m, since in the case of particularly small through-hole structures, formation difficulties such as core damage and material break-outs can very easily occur.
  • the nozzle opening is formed by a so-called “lost" part, which is initially injected with it.
  • the "lost" part is made of a suitable material so that it can be removed either directly by melting and / or evaporation, for example during sintering, or in a separate process step, for example by etching. This process is suitable for creating nozzle openings in the size range of 50 to 200 ⁇ m.
  • the nozzle opening 26 can be produced by laser ablation of the already finished and / or sintered component 25, in particular by laser drilling. As a result, nozzle openings 26 with a (minimum) diameter of less than 50 ⁇ m can be produced.
  • laser processing it is in particular possible to produce nozzle openings 26 or other bores with a diameter of about 20 to 30 microns at a depth or length of about 30 to 200 microns.
  • the nozzle opening 26 can have a largely constant diameter at least over the majority of the entire length. Particularly preferred can be created by the laser inlet and / or outlet side widening, in particular a funnel-like region.
  • FIG. 8 shows a sectional schematic section of a casting mold with an inner part 49 and an outer member 50 and a cavity formed therebetween, in which the member 25 is injection molded.
  • a shaped piece 51 is preferably also included as a "lost" part in order to form the nozzle opening 26.
  • the molding 51 constitutes a "lost" part that is removed before, during or after sintering the injection molded greenware 25 so as to at least partially form the nozzle opening 26.
  • the removal of the molding 51 can be done, for example, by melting and / or evaporation during sintering, by etching away or in any other suitable manner.
  • the "lost" part 51 does not constitute the entire nozzle opening 26 but, for example, only a part thereof.
  • the shaped piece 51 is cast in such a way that a side, here the outlet side, remains covered by a material region 52.
  • the nozzle opening 26 is preferably opened by removal of a flat side, in this case the outside.
  • the removal can be carried out, for example, by grinding, laser ablation or in any other suitable manner.
  • a pulsed laser is preferably used.
  • other suitable removal methods can additionally be used.
  • a wire or the like is preferably used in the illustrated example.
  • the molding 51 may also be fixed to the mold, here the inner part 49, connected or formed thereof.
  • the nozzle opening 26 is formed at least partially directly during molding of the injection-molded green compact.
  • the casting mold is preferably itself produced as an injection-molded sintered component, in particular in PIM technology, particularly preferably in MIM or CIM technology, as already mentioned.
  • the casting mold then provides an intermediate tool that molds a tool.
  • the above-mentioned occurring shrinkage of the intermediate tool or the mold during sintering has the consequence that the microstructures shrink accordingly.
  • the sintered intermediate tool - that is, the already sintered mold - directly finer microstructures are accordingly molded in the green compact.
  • a further shrinkage takes place, so that the microstructuring accordingly becomes even finer or smaller.
  • the component 25 is thus produced by being made at least substantially or exclusively in PIM technology in the mold, which in turn is made of sintered material and / or produced in PIM technology to reduce microstructures.
  • shrinkage may be used in PIM technology or in sintering to use the size of negatively-molded microstructures as a template for further molding.
  • the materials 53 and 54 may differ in particular with regard to their composition and / or particle sizes or particle size distributions.
  • a particularly fine-grained material 53 can be used to ensure a highly accurate impression of the microstructures.
  • the further, here outer material 54 can, for example, be coarser in order to form macrostructures and / or outer retaining structures or reinforcements.
  • the different materials 53 and 54 may be injected successively and / or simultaneously, more preferably into the same mold and / or by means of different molds, for example by changing the outer part 50 after the first material 53 has been cast against the inner part 49.
  • both microstructures and macrostructures of the component 25 are produced in one piece and / or at least substantially or exclusively in PIM technology, particularly preferably in CIM technology, or made of ceramic.
  • the structures are preferably produced in the same working step and / or in the same casting mold.
  • the component 25 is produced with a nozzle opening 26 in that the component 25 is produced at least substantially or exclusively in PIM technology, the nozzle opening 26 being formed or opened by laser irradiation and / or laser drilling of the already sintered component 25.
  • nozzle opening 26 can also be introduced into the already finished microstructured or finished sintered component 25 by a separate removal process, ie not only by this processing or laser drilling.
  • the CIM injection molding is preferably carried out with low-relieving temperatures in the feed zone of only about 25 to 50 ° C and / or at temperatures at the entrance of the casting mold of preferably a maximum of 120 to 150 0 C.
  • the remaining heating power or heating preferably takes place only in the casting mold.
  • the proposed component 25 is particularly preferably made of ceramic, especially in CIM technology.
  • the component 25 can in principle also be produced in another way from ceramic or another suitable material.
  • the filter 30 preferably has small passage cross sections compared to inlet and / or outlet channels.
  • the microstructures are preferably arranged on the inside and with respect to an output direction of the nozzle opening 26 and / or around the nozzle opening 26.
  • microstructures preferably serve not only for fluid atomization, but also for microscopic filtering or fine filtering.
  • the component 25 preferably also has macroscopic media guide structures, in particular for air guidance, particularly preferably on the outlet side of the nozzle 12 or nozzle opening 26, in addition to the microstructures.
  • macroscopic media guide structures in particular for air guidance, particularly preferably on the outlet side of the nozzle 12 or nozzle opening 26, in addition to the microstructures.
  • an inlet air opening 15, not shown, may be formed in the collar or rim 38 and / or an outlet-side funnel or the like.
  • the inhaler 1 preferably has only one dynamic seal, in this case the seal 47, but no static seals.
  • the component 12 may be made of at least two different PIM starting materials 53, 54.
  • the pulverulent starting materials 53, 54 may differ, in particular, in their granule size and / or particle size distribution.
  • the structures forming the nozzle 12 or the microstructures are embodied in ceramic, while other areas, such as the outer structure of the pump housing, may be formed from another material, in particular also from metal.
  • the component 12 preferably has no potentially corrosive material, in particular only ceramic, in particular no metallic material, in the areas in contact with the fluid 2.
  • sealing elements can also be molded directly onto the component 25 or formed by this or its plastic 41.
  • At least one component made in PIM technology are injection-molded or injection-molded as an insert in a further injection molding process in order to form the component 25. This can also be done directly in a mold designed for this purpose.
  • the component 25 and / or the pump chamber 11 is at least substantially pot- or container-shaped or are that the component 25 is at least substantially rotationally symmetrical that the Nozzle opening 26 axially and the fluid inlet 28 extends radially thereto and / or extend transversely to each other and / or that the
  • Nozzle opening 26 is conical or funnel-shaped, that the component 25 has a receiving space for a particular a movable conveying element sealing gasket 47, that the component 25 as a reservoir 3 for the fluid 2, in particular only a single dose of the fluid 2, is formed
  • the component 25 is at least essentially made of ceramic or consists of the component 25 being made of different materials 53, 54 with respect to the composition and / or grain in PIM technology, that the component 25 is a retaining element 39, in particular integrally formed for holding of the component 25 and / or an at least partially injected, preferably metallic holding or reinforcing element 39, 40, and / or that the component 25 has an air-guiding structure, in particular a rim 38, preferably on the outlet side, that the component 25 at least partially, in particular with a plastic 41, is encapsulated that the B 25, in particular by means of a spring brace 42, in which inhaler 1 is held, that the component 25 is produced by a method according to any one of the following claims, that both microstructure
  • the structures are produced in the same working step and / or in the same casting mold, that the casting mold is or has been produced by PIM technology, and / or that microstructures with structure depths and / or broad in the range of 1 to 200 microns, preferably about 5 to 120 microns, more preferably substantially 10 to 90 microns are formed.
  • the fluid 2 is a liquid, as already mentioned, in particular an aqueous or ethanolic pharmaceutical formulation.
  • it may also be another drug formulation, a suspension or the like, or else particles or powder.
  • preferably medical fluid 2 preferred ingredients, compounds and / or formulations of the preferably medical fluid 2 are listed. As already mentioned, they may be aqueous or non-aqueous solutions, mixtures, ethanol-containing or solvent-free formulations or the like. Particular preference is given in fluid 2:
  • W is a pharmacologically active agent and (for example) selected from the group consisting of betamimetics, anticholinergics, corticosteroids, PDE4 inhibitors, LTD4 antagonists, EGFR inhibitors, dopamine agonists, HIV antihistamines, PAF antagonists and PB kinase inhibitors.
  • a pharmacologically active agent selected from the group consisting of betamimetics, anticholinergics, corticosteroids, PDE4 inhibitors, LTD4 antagonists, EGFR inhibitors, dopamine agonists, HIV antihistamines, PAF antagonists and PB kinase inhibitors.
  • two- or three-fold combinations of W can be combined and used for application in the device according to the invention. Exemplary combinations of W would be:
  • W represents a betamimetic combined with an anticholinergic, corticosteroid, PDE4 inhibitor, EGFR inhibitor or LTD4 antagonist
  • W represents a corticosteroid combined with a PDE4 inhibitor, EGFR inhibitors or LTD4 antagonists
  • W represents a PDE4 inhibitor combined with an EGFR inhibitor or LTD4 antagonist
  • W represents an EGFR inhibitor combined with a LTD4 antagonist.
  • Preferred betamimetics are compounds selected from the group consisting of albuterol, arformoterol, bambuterol, bitolterol, broxaterol, carbuterol, clenbuterol, fenoterol, formoterol, hexoprenaline, ibuterol, isoetharines, isoprenaline, levosalbutamol, mabuterol , Meluadrine, Metaproterenol, Orciprenaline, Pirbuterol, Procaterol, Reproterol, Rimiterol, Ritodrine, Salmefamol, Salmeterol, Soterenol, Sulphone terol, Terbutaline, Tiaramide, Tolubuterol, Zinterol, CHF-1035, HO-KU-81, KUL-1248 and
  • N-adamantan-2-yl-2- (3- ⁇ 2- [2-hydroxy-2- (4-hydroxy-3-hydroxymethylphenyl) -ethylamino] -propyl ⁇ -phenyl) -acetamide optionally in the form of their racemates, enantiomers, diastereomers and optionally in the form of their pharmacologically acceptable acid addition salts, solvates or hydrates.
  • the acid addition salts of the betamimetics are selected from the group consisting of hydrochloride, hydrobromide, hydroiodide, hydrosulfate, hydrophosphate, hydromethanesulfonate, hydronitrate, hydromaleate, hydroacetate, hydrocitrate, hydro fumarate, hydrotartrate, hydroxalate, hydrosuccinate, hydrobenzoate and hydro-p-toluenesulfonate.
  • Preferred anticholinergic compounds are compounds which are selected from the group consisting of tiotropium salts, preferably the bromide salt, oxitropium salts, preferably the bromide salt, flutropium salts, preferably the bromide salt, ipratropium salts, preferably the bromide salt, glycopyrronium salts, preferably the bromide salt, trospi - salt, preferably the chloride salt, tolterodine.
  • the cations are the pharmacologically active ingredients.
  • the aforementioned salts may preferably contain chloride, bromide, iodide, sulfate, phosphate, methanesulfonate, nitrate, maleate, acetate, citrate, fumarate, tartrate, oxalate , Succinate, benzoate or p-toluenesulfonate, with chloride, bromide, iodide, sulfate, methanesulfonate or p-toluenesulfonate being preferred as counterions.
  • the chlorides, bromides, iodides and methanesulfonates are particularly preferred.
  • anticholinergics are selected from the salts of the formula AC-I
  • X ⁇ is a singly negatively charged anion, preferably an anion selected from the group consisting of fluoride, chloride, bromide, iodide, sulfate, Phosphate, methanesulfonate, nitrate, maleate, acetate, citrate, fumarate, tartrate, oxalate, succinate, benzoate and p-toluenesulfonate, preferably a single negatively charged anion, more preferably an anion selected from the group consisting of fluoride, chloride, bromide, methanesulfonate and p-toluenesulfonate, particularly preferably bromide, optionally in the form of their racemates, enantiomers or hydrates.
  • anion selected from the group consisting of fluoride, chloride, bromide, methanesulfonate and p-toluenesulfonate, particularly preferably bromide, optionally in the form
  • the compound of formula AC-2 may also be in the form of the free base AC-2-base.
  • Preferred corticosteroids are compounds selected from the group consisting of beclomethasone, betamethasone, budesonide, butixocort, ciclesonide, deflazacort, dexamethasone, etiprednol, flunisolide, fluticasone, loteprednol, mometasone, prednisolone, prednisone, rofleponide, Triamcinolone, RPR-106541, NS-126, ST-26 and
  • Examples of possible salts and derivatives of steroids may be: alkali metal salts, such as sodium or potassium salts, sulfobenzoates, phosphates, isonicotinates, acetates, dichloroacetates, propionates, dihydrogen phosphates, palmitates, pivalates or furoates.
  • alkali metal salts such as sodium or potassium salts, sulfobenzoates, phosphates, isonicotinates, acetates, dichloroacetates, propionates, dihydrogen phosphates, palmitates, pivalates or furoates.
  • Preferred PDE4 inhibitors here are compounds selected from the group consisting of enprofylline, theophylline, roflumilast, ariflo (cilomilast), tofimilast, pumafentrin, lirilmast, arofylline, atizoram, D-4418, bay 198004, BY343, CP-325,366, D-4396 (Sch-351591), AWD-12-281 (GW-842470), NCS-613, CDP-840, D-4418, PD-168787, T-440, T-2585, V-11294A, Cl-1018, CDC-801, CDC-3052, D-22888, YM-58997, Z-15370 and
  • the acid addition salts of the betamimetics are selected from the group consisting of hydrochloride, hydrobromide, hydroiodide, hydrosulfate, hydrophosphate, hydromethanesulfonate, hydronitrate, hydromaleate, hydroacetate, hydrocitrate, hydro fumarate, hydrotartrate, hydroxalate, hydrosuccinate, hydrobenzoate and hydro p-toluenesulfonate.
  • Preferred LTD4 antagonists here are compounds selected from the group consisting of montelukast, pranlukast, zafirlukast, MCC-847 (ZD-3523), MN-001, MEN-91507 (LM-1507), VUF-5078 , VUF-K-8707, L-733321 and
  • the acid addition salts of the betamimetics are selected from the group consisting of hydrochloride, hydrobromide, hydroiodide, hydrosulfate, hydrophosphate, hydromethanesulfonate, hydronitrate, hydromaleate, hydroacetate, hydrocitrate, hydro fumarate, hydrotartrate, hydroxalate, hydrosuccinate, hydrobenzoate and hydro p-toluenesulfonate.
  • salts or derivatives whose formation the LTD4 antagonists are capable of are: alkali metal salts, such as, for example, sodium or potassium salts, alkaline earth salts, sulfobenzoates, phosphates, isonicotinates, acetates, propionates, dihydrogen phosphates, palmitates, pivalates or also furoate.
  • alkali metal salts such as, for example, sodium or potassium salts, alkaline earth salts, sulfobenzoates, phosphates, isonicotinates, acetates, propionates, dihydrogen phosphates, palmitates, pivalates or also furoate.
  • the EGFR inhibitors used are preferably compounds selected from the group consisting of cetuximab, trastuzumab, ABX-EGF, Mab ICR-62 and
  • the acid addition salts of the betamimetics are selected from the group consisting of hydrochloride, hydrobromide, hydroiodide, hydrosulfate, hydrophosphate, hydromethanesulfonate, hydronitrate, hydromaleate, hydroacetate, hydrocitrate, hydro fumarate, hydrotartrate, hydroxalate, hydrosuccinate, hydrobenzoate and hydro-p-toluenesulfonate.
  • Preferred dopamine agonists are compounds selected from the group consisting of bromocriptine, cabergoline, alpha-dihydroergocryptine, lisuride, pergolide, pramipexole, rooxinol, ropinirole, talipexol, terguride and viozan, optionally in the form of their racemates , Enantiomers, diastereomers and optionally in the form of their pharmacologically acceptable acid addition salts, solvates or hydrates.
  • the acid addition salts of the betamimetics are selected from the group consisting of hydrochloride, hydrobromide, hydroiodide, hydrosulfate, hydrophosphate, hydromethanesulfonate, hydronitrate, hydromaleate, hydroacetate, hydrocitrate, hydrofumarate, hydrotartrate, hydroxalate, hydrosuccinate, hydrobenzoate and hydro-p -toluolsulfonat.
  • Hl -Antihistaminika here are preferably compounds used, which are selected from the group consisting of epinastine, cetirizine, azelastine, fexofenadine, levocabastine, loratadine, mizolastine, ketotifen, emedastine, dimetindene, clemastine, bamipine, Cexchlorpheniramin, phenamine , Doxylamine, chlorphenoxamine, dimenhydrinate, diphenhydramine, promethazine, ebastine, desloratidine and meclocine, optionally in the form of their racemates, enantiomers, diastereomers and optionally in the form of their pharmacologically acceptable acid addition salts, solvates or hydrates.
  • the acid addition salts of the betamimetics are selected from the group consisting of hydrochloride, hydrobromide, hydroiodide, hydrosulfate, hydrophosphate, hydromethanesulfonate, hydronitrate, hydromaleate, hydroacetate, hydrocitrate, hydrofumarate, hydrotartrate, hydroxalate, hydrosuccinate, hydrobenzoate and hydro-p -toluolsulfonat.
  • inhalable macromolecules may be used as disclosed in EP 1 003 478 A1 or CA 2297174 A1.
  • the compound may be derived from the group of derivatives of ergot alkaloids, triptans, CGRP inhibitors, phosphodiesterase V inhibitors, optionally in the form of their racemates, enantiomers or diastereomers, optionally in the form of their pharmacologically acceptable acid addition salts, their solvates and / or hydrates.

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  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Ceramic Engineering (AREA)
  • Manufacturing & Machinery (AREA)
  • Health & Medical Sciences (AREA)
  • Materials Engineering (AREA)
  • Structural Engineering (AREA)
  • Organic Chemistry (AREA)
  • Mechanical Engineering (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Composite Materials (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)

Abstract

L'invention concerne un composant de pulvérisation d'un fluide, un inhalateur et un procédé de fabrication du composant. Le composant présente des microstructures et des macrostructures qui forment une tuyère et une chambre de pompage. Le composant est formé d'un seul tenant et est réalisé en céramique ou en métal par la technologie PIM (moulage de poudre par injection).
PCT/EP2009/009290 2009-01-02 2009-12-28 Composant et inhalateur ainsi que procédé de fabrication d'un composant WO2010076012A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09000004 2009-01-02
EP09000004.3 2009-01-02

Publications (1)

Publication Number Publication Date
WO2010076012A1 true WO2010076012A1 (fr) 2010-07-08

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PCT/EP2009/009290 WO2010076012A1 (fr) 2009-01-02 2009-12-28 Composant et inhalateur ainsi que procédé de fabrication d'un composant

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102011082740B4 (de) 2011-09-15 2022-03-03 Robert Bosch Gmbh Verfahren zur Herstellung einer Kolbenpumpe mit einem Gehäuse und mindestens einem in einer Kolbenführung des Gehäuses angeordneten axial bewegbaren Kolben
WO2022241925A1 (fr) * 2021-05-19 2022-11-24 余姚市丹丹喷雾器有限公司 Tête de pressage de matériau tout-pp
EP4230377A3 (fr) * 2022-01-26 2023-09-20 Aero Pump GmbH Corps de buse
GB2623309A (en) * 2022-10-10 2024-04-17 Merxin Ltd Nozzle holder
EP4389295A1 (fr) * 2022-12-23 2024-06-26 Aero Pump GmbH Filtre pour corps de buse conique creuse
DE102022134680A1 (de) 2022-12-23 2024-07-04 Aero Pump Gmbh Doppelstrahldüsenkörper

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993017820A1 (fr) * 1992-03-05 1993-09-16 Abb Cerama Ab Procede de retrait des noyaux pendant le moulage par injection d'objets a partir de metaux et/ou de ceramiques a l'etat de poudres
US5435884A (en) 1993-09-30 1995-07-25 Parker-Hannifin Corporation Spray nozzle and method of manufacturing same
DE19622124A1 (de) * 1996-06-01 1997-12-04 Alfred Von Schuckmann Gerät zum Aufbringen von Flüssigkeiten
CA2297174A1 (fr) 1997-08-04 1999-02-18 Boehringer Ingelheim Pharma Kg Preparations d'aerosols aqueuses contenant des macromolecules biologiquement actives et procede de production des aerosols correspondants
EP0970741A1 (fr) 1997-07-17 2000-01-12 Shiseido Company Limited Emulsion a phases multiples de type huile/eau/huile
WO2002043942A1 (fr) * 2000-11-30 2002-06-06 Ceram Research Limited Moule a injection muni d'une surface poreuse et procede d'utilisation
US20030075623A1 (en) * 1992-09-29 2003-04-24 Frank Bartels Atomising nozzel and filter and spray generating device
US7198201B2 (en) * 2002-09-09 2007-04-03 Bete Fog Nozzle, Inc. Swirl nozzle and method of making same
WO2007101557A2 (fr) 2006-03-07 2007-09-13 Boehringer Ingelheim International Gmbh Buse à turbulence

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993017820A1 (fr) * 1992-03-05 1993-09-16 Abb Cerama Ab Procede de retrait des noyaux pendant le moulage par injection d'objets a partir de metaux et/ou de ceramiques a l'etat de poudres
US20030075623A1 (en) * 1992-09-29 2003-04-24 Frank Bartels Atomising nozzel and filter and spray generating device
US5435884A (en) 1993-09-30 1995-07-25 Parker-Hannifin Corporation Spray nozzle and method of manufacturing same
US5951882A (en) 1993-09-30 1999-09-14 Parker Intangibles Inc. Spray nozzle and method of manufacturing same
DE19622124A1 (de) * 1996-06-01 1997-12-04 Alfred Von Schuckmann Gerät zum Aufbringen von Flüssigkeiten
EP0970741A1 (fr) 1997-07-17 2000-01-12 Shiseido Company Limited Emulsion a phases multiples de type huile/eau/huile
CA2297174A1 (fr) 1997-08-04 1999-02-18 Boehringer Ingelheim Pharma Kg Preparations d'aerosols aqueuses contenant des macromolecules biologiquement actives et procede de production des aerosols correspondants
EP1003478A1 (fr) 1997-08-04 2000-05-31 Boehringer Ingelheim Pharma KG Preparations d'aerosols aqueuses contenant des macromolecules biologiquement actives et procede de production des aerosols correspondants
WO2002043942A1 (fr) * 2000-11-30 2002-06-06 Ceram Research Limited Moule a injection muni d'une surface poreuse et procede d'utilisation
US7198201B2 (en) * 2002-09-09 2007-04-03 Bete Fog Nozzle, Inc. Swirl nozzle and method of making same
WO2007101557A2 (fr) 2006-03-07 2007-09-13 Boehringer Ingelheim International Gmbh Buse à turbulence

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102011082740B4 (de) 2011-09-15 2022-03-03 Robert Bosch Gmbh Verfahren zur Herstellung einer Kolbenpumpe mit einem Gehäuse und mindestens einem in einer Kolbenführung des Gehäuses angeordneten axial bewegbaren Kolben
WO2022241925A1 (fr) * 2021-05-19 2022-11-24 余姚市丹丹喷雾器有限公司 Tête de pressage de matériau tout-pp
EP4230377A3 (fr) * 2022-01-26 2023-09-20 Aero Pump GmbH Corps de buse
GB2623309A (en) * 2022-10-10 2024-04-17 Merxin Ltd Nozzle holder
EP4389295A1 (fr) * 2022-12-23 2024-06-26 Aero Pump GmbH Filtre pour corps de buse conique creuse
DE102022134681A1 (de) 2022-12-23 2024-07-04 Aero Pump Gmbh Filter für Hohlkegeldüsenkörper
DE102022134680A1 (de) 2022-12-23 2024-07-04 Aero Pump Gmbh Doppelstrahldüsenkörper

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