WO2016116267A1 - Inhalateur à poudre, ses modules, son récipient à poudre et son logement de canal à air ainsi qu'utilisation de l'inhalateur à poudre - Google Patents

Inhalateur à poudre, ses modules, son récipient à poudre et son logement de canal à air ainsi qu'utilisation de l'inhalateur à poudre Download PDF

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Publication number
WO2016116267A1
WO2016116267A1 PCT/EP2016/000080 EP2016000080W WO2016116267A1 WO 2016116267 A1 WO2016116267 A1 WO 2016116267A1 EP 2016000080 W EP2016000080 W EP 2016000080W WO 2016116267 A1 WO2016116267 A1 WO 2016116267A1
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WO
WIPO (PCT)
Prior art keywords
air
powder container
powder
receiving cavity
air duct
Prior art date
Application number
PCT/EP2016/000080
Other languages
German (de)
English (en)
Inventor
Klaus-Dieter Beller
Original Assignee
Klaus-Dieter Beller
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 Klaus-Dieter Beller filed Critical Klaus-Dieter Beller
Publication of WO2016116267A1 publication Critical patent/WO2016116267A1/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
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/002—Details of inhalators; Constructional features thereof with air flow regulating means
    • 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
    • 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
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/12—Preparation of respiratory gases or vapours by mixing different gases
    • A61M16/122—Preparation of respiratory gases or vapours by mixing different gases with dilution
    • A61M16/125—Diluting primary gas with ambient air
    • A61M16/127—Diluting primary gas with ambient air by Venturi effect, i.e. entrainment mixers
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/064—Powder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6063—Optical identification systems

Definitions

  • the following invention relates to a powder inhaler, the constituent constituent units powder container and air duct housing and the use of the powder inhaler.
  • Powder inhalers for sublingual, nasal and inhalative administration of powdered, solid-state drugs or other active agent-containing agents are known. They can be designed as propellant-free application devices and release an aerosol through the inspiratory process, respectively a deep inhalation process. The energy for the dispersion is gained through the inspiratory flow.
  • the powdery substance is contained in a storage container; Special storage containers such as blisters, capsules, containers, cartridges and other pharmaceutical packaging are also known.
  • the pure active ingredient or the active ingredient is used with a carrier which is a safe excipient such as lactose or glucose for adhered drug particles.
  • the storage container has stored the powdered medicament in a multiple metering amount, a metering device must be assigned to the container or to the powder inhaler which is used with the container.
  • a metering device is unnecessary when the powder container used in the powder inhaler contains a single dose.
  • a main focus of these single-dose inhalers is therefore on the opening of the powder container.
  • the single-dose container inserted in a powder inhaler is perforated, for example, with needles or thorns, or a sealing film is peeled off so that the inhaled air flows through the perforated or opened container or passes through the opened container and entrains the powder contained.
  • US Pat. No. 7,305,986 B1 discloses single-dose capsules as storage containers for use in a powder inhaler.
  • a capsule consists of two sleeves, which are arranged inside each other and can be rotated against each other between a locked and unlocked position. In the unlocked position, at least one opening in the first sleeve is aligned with an opening in the second sleeve, so that the capsule with a
  • CONFIRMATION COPY Drug can be filled.
  • at least two further openings in the first sleeve are aligned with at least two openings in the second sleeve so that air can pass through the capsule, thereby releasing the drug in the capsule.
  • vortex-generating structures are called cones extending from the inner walls of the sleeves.
  • WO 2009/121020 A1 discloses an inhalation system comprising a powder container and an easy-to-use and insensitive powder inhaler with uniform release of active substance.
  • the powder inhaler includes a housing having a mouthpiece engaging portion having an air inlet, a powder container chamber, and an air outlet.
  • the mouthpiece is movable in the engagement portion of the housing in an engaged position and can be disengaged from the housing in a predetermined position.
  • WO 2014/012069 A2 describes a powder inhaler with a mouthpiece component and a component which receives a powder container. There are at least two rigid air ducts in the components, at least one of which, in use, is configured to have a baffle or pegs to direct movement of the dry powder in the powder container.
  • the powder inhaler may include a movable member for moving the powder container from a storage position to a metering configuration.
  • the further object is to provide a powder container for a powder to be inhaled, so that it can be easily and skillfully administered with a suitable inhaler, and is achieved by a powder container having the features of independent claim 12
  • An inventive powder inhaler consists of the assemblies air duct housing and powder container, which - depending on the embodiment - releasably or permanently, but is movably received in a receiving cavity of the air duct housing.
  • the powder container has at least one chamber which can contain or receive a powder dose and which is delimited by a wall with at least one air inlet opening and air outlet opening.
  • the wall of the chamber of the powder container is shaped and dimensioned according to the receiving cavity of the air duct housing.
  • the air duct housing in turn limits at least one air duct, which connects an air inlet with the receiving cavity and the receiving cavity with an air outlet, which is formed as a mouthpiece or nosepiece.
  • the air duct is advantageously located on an axis with the air inlet and the air outlet, which are formed at opposite ends of the air duct housing, so that the breath stream used during inhalation is used efficiently.
  • the air duct housing is immovable with the air inlet and the air outlet; with a suitable choice of material (non-elastic plastic or metal) one can speak of a rigid housing. "Immovable” herein means essentially non-elastic and is also meant to include materials which are slightly flexurally elastic and thus are not considered to be completely rigid.
  • the powder container has an actuating element which is arranged adjacent to the at least one chamber.
  • the powder container may be transferred by means of the actuating element from a blocking position, in which at least one closed wall portion of the wall of the powder container forms a barrier in the air channel between the air inlet and the air outlet of the air duct housing in a release position.
  • a fluid path is released or also provided, which is supplied from the air inlet through the air channel of the air container. through the air inlet opening, the chamber and the air outlet opening of the powder container and through the air channel to the air outlet of the air channel housing.
  • the powder container can be moved directly by means of the actuating element in the receiving cavity.
  • the powder container according to the invention which can be easily inserted into the receiving cavity, by actuation of the Actuator be moved directly into a release position.
  • the air duct housing can thus be extremely simple, without joints and without bypass, are constructed and therefore cost manufacturable.
  • the actuator of the arranged in the receiving cavity of the air duct housing powder container may protrude from the receiving cavity or uncovered be present within a receiving opening of the receiving cavity, so that the actuator can be used directly and directly.
  • Each chamber may have a filling opening which is not the air inlet or outlet opening and which may preferably be present on a base surface of the wall opposite the actuating element. Through this filling opening the powder dose can get into the chamber.
  • an edge portion of the wall may be formed about the fill opening with prongs, whereby blockage of the powder container when installed in the receiving cavity or in the release position can be prevented by the powder present in the chamber or the receiving cavity.
  • the receiving cavity may have a receiving base opposite to a receiving opening through which the powder container is received, so be closed on one side, or have a further opening.
  • This further opening may or may be closed by a cover hinged to the air duct housing adjacent to the further opening, which is preferably manufactured in one piece with the air duct housing, or by a separate cover.
  • cover here are closing elements in the broad sense to be understood: There are covers by films, such as plastic or metal, just as a lid to understand as solid cover. The closure can, in particular, if a repeated use of the air duct housing is provided, reversible, ie again be apparent.
  • the receiving cavity has a receiving bottom relative to a receiving opening, ie is closed on one side, or has a further opening.
  • the air inlet and outlet openings of the powder container can be closed with an openable closure means, so that the powder container is sealed outside of an air duct housing, and when stored no powder and no air or moisture can penetrate.
  • the air inlet and outlet openings may also be closed only by the wall of the receiving cavity in the blocking position.
  • the filling opening of the chamber for. B.
  • the filling opening of the chamber can also be closed by closing this further opening of the receiving cavity by the separate lid which can be fastened to the receiving cavity or by a lid hinged to the air duct housing.
  • air inlet and outlet openings on the powder container in shape and cross section correspond to the air inlet and outlet openings of the air channel housing on the receiving cavity.
  • the air inlet and outlet openings and the filling opening are closed by means of a sleeve closed on one side, in which the wall of the powder container or within the wall rotationally and / or is recorded translationally movable.
  • This sleeve has at least two openings which correspond in number, dimensions and relative position to one another the chamber associated with air inlet and -auslassö Anlagenen.
  • this sleeve has at least one fitting or latching element for engagement with a corresponding counter-pass or latching element which is present in the receiving cavity of the air duct housing and is positioned such that the at least two openings of the sleeve are connected to the air duct of the air duct housing and thus to the air inlet housing. and -auslassö réelle the powder container in the release position are aligned.
  • the powder container can have one or more latching elements and alternatively or additionally one or more stops and the air duct housing on or in the receiving cavity at least one corresponding latching element and / or a corresponding stop, so that the corresponding latching elements and / or stops are engaged with each other can be used to ensure correct positioning of the powder container in the receiving cavity of the air duct housing.
  • the receiving cavity of the air duct housing may be cylindrically shaped with circular or polygonal base, so that the wall of the powder container is shaped and dimensioned correspondingly cylindrical with a circular or polygonal base, wherein the wall with the actuating element in one piece, preferably made of injection molded plastic, can be made.
  • the wall with the actuating element in one piece preferably made of injection molded plastic
  • a rotational, translational movement or a combination of both movements of the powder container in the receiving cavity in question For rotary or combined mobility circular cylindrical walls are required, while a pure translational movement for both cylinders with polygonal and circular, or even elliptical or ovoid base is possible.
  • the actuator for the corresponding rotating or sliding or pulling operation can be formed.
  • the actuator may for example also mushroom-like designed as a push button.
  • the air duct housing may be integrally formed in a preferred embodiment.
  • the air outlet can be formed as a mouthpiece or nose, depending on the requirements, a mouthpiece can be round or square with rounded contours or oval, which u. a. also influences the flow behavior of the drawn-in air flow in the application of the powder inhaler.
  • the powder container may have two or more chambers that are longitudinally stacked with respect to the longitudinal axis of the cylindrical wall. possibly on both sides of the actuating element, are arranged.
  • the air inlet opening and the air outlet opening of each chamber can here-as in the case of the simple powder containers with only one chamber-be formed opposite in the wall, ie on an imaginary diameter line, whereby an air inlet opening and an air outlet opening of the air channel at the receiving cavity accordingly is provided opposite arranged.
  • the powder container may have two or more sector-cylindrical chambers, which are arranged in cross-section adjacent to each other within the cylindrical wall.
  • Such a multi-chambered powder container can then be used in multiple inhalation applications with an air duct housing to inhale a dose of powder each time.
  • the actuator also allows the simple and correct positioning of the respective chamber in the air duct housing.
  • the air inlet and outlet openings of each chamber within the respective cylinder sector lie in the wall and thus no longer on an imaginary diameter line, so that the air inlet and outlet openings of the air channel are arranged on the receiving cavity corresponding to the air inlet and outlet openings of each chamber.
  • Each chamber may contain one or more air turbulence structures. This may, for example, be understood to mean an air swirling structure extending from an inner wall of the chamber, which is preferably formed integrally therewith.
  • a separate disagglomerator loosely present in the chamber may be provided, which is dimensioned such that it does not fit in any orientation through the air inlet and outlet openings.
  • a loose disagglomerator is not solid, but designed with air passages to prevent blockage of the air outlet port in the application of the powder inhaler.
  • the air inlet opening may have a larger diameter than the air outlet opening; Furthermore, for this purpose, a profile of the air inlet and / or air outlet in the wall can be sharp-edged, chamfered or rounded.
  • the actuator may include one or more markers that provide information about the orientation of the air inlet and outlet ports with respect to provides the actuator and thus allows a check of the correct positioning of the powder container in the receiving cavity of the air duct housing.
  • the air channel in the air channel housing may taper in diameter from the air inlet to the receiving cavity such that the flow rate increases and widens in diameter from the receiving cavity to the air outlet so that the speed decreases again.
  • the taper and the expansion can each be uniform and continuous or alternatively divided into at least two sections / steps with different pitch.
  • At least a portion of the inlet or outlet air duct may be parabolic.
  • provision may be made for the air inlet to have air guiding structures, at least in the first section, on the inner wall, which may preferably be helical or spirally extending guide webs which set the drawn-in air stream in torsion.
  • other sections in air inlet and outlet can be equipped with air guiding structures.
  • a further article according to the invention is a powder container for a powder inhaler which has an air duct housing with a receiving cavity for the powder container, wherein the powder container has at least one chamber for receiving a powder dose which is bounded by a wall with at least one air inlet opening and air outlet opening.
  • a powder container according to the invention is designed for releasable placement in a powder inhaler according to the invention.
  • An air duct housing according to the invention as a structural unit for forming a powder inhaler in cooperation with a powder container according to the invention has an air inlet, a receiving cavity for the powder container and an air outlet formed as an oral or nasal piece, wherein at least one air duct the air inlet with the receiving cavity and the receiving cavity with the air outlet combines.
  • the air duct housing is ungelenkig, substantially rigid and immovable in the above sense (when using inelastic materials), or formed with slight bending elasticity when using elastic plastics with the air inlet and the air outlet at opposite ends and theMonkavmaschine is shaped according to a wall of the powder container and dimensioned.
  • the powder container can thus be received in such a way through the receiving opening in the receiving cavity. that the actuating element of the arranged in the receiving cavity of the air duct housing powder container is freely operated.
  • a use according to the invention of the powder inhaler for inhaling a powder dose comprises transferring the powder container from the blocking position into the release position by actuating the actuating element.
  • FIG. 1 perspective views of a powder inhaler according to the invention a) before
  • FIG. 2 shows longitudinal sectional views of a powder inhaler according to the invention with air duct housing and powder container in a) closure position and b) release position and c) an enlarged detailed representation from a),
  • FIG. 4 shows front views of the mouth outlet of a powder inhaler according to the invention with air duct housing and powder container in a) closure position and b) release position and rear views on the air inlet of a powder inhaler according to the invention with air duct housing and powder container in c) closure position and d) release position,
  • Fig. 5 are side views of a powder container with different sized Amsterdamein- and
  • FIG. 6 a) a side view of a powder container with prongs, and b) a perspective view of a powder container with prongs and an alternative actuating element, 7 is a partial perspective sectional view of a powder inhaler according to the invention with a powder container with tines,
  • FIG. 8 is a longitudinal sectional view a) and a perspective view b) of an air duct housing of a powder inhaler according to the invention
  • FIG. 10 shows longitudinal, transverse and detail views a) to f) of a powder container accommodated in the air duct housing with a hinged lid with an alternative actuating element
  • FIG. 11 is a perspective view a) and a longitudinal sectional view b) of a powder container of a powder inhaler according to the invention
  • FIG. 13 is a bottom view a) and a longitudinal sectional view b) of a powder container with integrated BeerverwirbelungsFig an alternative embodiment of a powder inhaler according to the invention
  • FIG. 15 shows a bottom view a) and a longitudinal sectional view b) of a powder container with integrated air swirling structure of an alternative embodiment of a powder inhaler according to the invention
  • 16 is a bottom view a) and a longitudinal sectional view b) of a powder container with integrated BeerverwirbelungsFig an alternative embodiment of a powder inhaler according to the invention
  • FIG. 17 is a bottom view a) and a longitudinal sectional view b) of a powder container with integrated BeerverwirbelungsFig an alternative embodiment of a powder inhaler according to the invention
  • 18 is a bottom view a) and a longitudinal sectional view b) of a powder container with integrated BeerverwirbelungsFig an alternative embodiment of a powder inhaler according to the invention
  • 19 is a perspective view a) and a longitudinal sectional view b) of a powder container with hexagonal base of a powder inhaler according to the invention
  • Fig. 20 is a partial perspective sectional view of one in a correspondingly shaped
  • 21 is a perspective view a) and a longitudinal sectional view b) of a powder container with two chambers,
  • FIG. 22 is a cross-sectional view of a dual chamber powder container in an alternative embodiment
  • FIG. 23 is a longitudinal sectional view a), a plan view b) of a powder inhaler according to the invention with air duct housing with alternative mouthpiece and powder container in the release position and a perspective view c) of this powder inhaler with powder container in the closed position,
  • FIG. 24 shows schematic side sectional views of production steps of a powder container for a powder inhaler according to the invention
  • 25 is a side sectional view through a powder inhaler according to the invention with a capped receiving cavity by 2k injection molding process
  • 26 shows side sectional views of a powder inhaler according to the invention according to an alternative production method
  • FIG. 27 is side and cross-sectional views of manufacturing steps of a hexagonal powder container powder inhaler according to the invention.
  • Fig. 31 a) a perspective view, b) a top view, c) a view of the
  • Mouthpiece d) a view of the air inlet, e) a side sectional view for filling, f) a side sectional view during storage and g) a side sectional view during the use of an alternative shaped powder inhaler according to the invention,
  • the device according to the invention relates to a powder container and an air duct housing and a powder inhaler formed therefrom.
  • the air duct housing defines an air inlet, a receiving cavity for the powder container and an air outlet formed as a mouthpiece or nosepiece. At least one air duct connects the air inlet with the receiving cavity and this with the air outlet.
  • the powder container disposed in the receiving cavity projects out of the receiving cavity with an actuator so that the powder container can be moved by means of the actuating member in the receiving cavity between a blocking position in which the powder container closes the air channel between the air inlet and the air outlet, and a release position wherein a fluid communication between the air duct and the interior of the powder container is provided.
  • the receiving cavity is quasi a valve chamber, in which the powder container is arranged as a valve.
  • the powder container in the receiving cavity about its longitudinal axis, which is perpendicular to an axis defined by the air duct, rotated or moved longitudinally to its longitudinal axis.
  • the receiving cavity or the powder container can be designed so that the active ingredient-containing powder is absorbed either by a direct air flow, by local underpressure formation (Venturi principle) or by whirling up into the air flow.
  • the air duct housing can be formed in one piece and can be manufactured cost-effectively in plastic injection molding.
  • Air inlet and outlet are on the air duct housing, immovable, d. H. is executed without articulation, preferably formed at opposite ends.
  • the air outlet can be formed not only as a mouthpiece, but also as a nose trunk.
  • FIGS. 1 to 4 show various views of an exemplary powder inhaler 1 according to the invention, which consists of a powder container 2 and an air duct housing 3.
  • the powder container 2 is shown prior to placement in the receiving cavity 32.
  • the powder container 2 is in the blocking position, since the air outlet opening 23 '(the air inlet opening is not visible in this illustration) and a corresponding web 24 as a mark on the running knurled actuator 22 is perpendicular to the air duct, axially through the air duct housing 3 runs.
  • the air duct extends from the air inlet 31 with a first funnel-shaped to the receiving cavity 32, and thence to the air outlet 33 having a first, widening portion 33 'and a second mouthpiece shaped portion 33 ".
  • the powder container 2 is shaped and dimensioned with its wall 21 corresponding to the receiving cavity 32, so that it can be inserted precisely through the receiving opening 32 'into the receiving cavity 32.
  • the running as a thumbwheel actuator 22 of the powder container 2 comes to lie on the receiving opening 32 ', so that a tangentially shaped stop 22' of the knurl 22 comes to rest with its first stop side on a counter-stop 35 'of the receiving cavity 32.
  • the cross-sectional widening there initially ensures a reduction in the flow velocity and thus achieves a spacer effect, ie the active substance particles are distributed uniformly in the air flow, which then reaches the user through the mouthpiece 33 "at the air outlet 33.
  • the powder container 2 used can not be accidentally removed from the receiving cavity 32, as shown in the detail illustration Fig. 2c, on the wall 21 of the container 2, a circumferential annular bead 21 "be formed in a corresponding annular groove 35" in the wall of the receiving cavity 32 can engage detent.
  • 3c shows, in addition to the web 24, which marks the position of the air outlet opening 23 ', a recess 24 "which marks the position of the air inlet opening 23 on the powder container 2 in the blocking position and recess differ, are used.
  • Fig. 4a-d illustrate the locking and release positions in views from the axial direction.
  • 4a, b show the view of the mouthpiece 33 "and Fig. 4c, d on the air inlet funnel 31 '.
  • the wall 21 of the powder container is in each case to be seen, which blocks the air channel, while in b) the air inlet opening 23 and in d) the air outlet opening 23 'of the powder container can be seen.
  • Fig. 5 shows an exemplary powder container 2, which adjacent to the wall 21 bounded by the chamber has a thumbwheel as actuator 22, by means of which the powder container 2 can be transferred from the lock to the release position, when the powder container in the receiving cavity of an air duct housing is arranged as shown in the examples of Figures 1 to 4.
  • the air inlet and outlet openings 23, 23 'of the powder container 2 can be seen in FIG. 5, the illustration showing that the air inlet opening 23 is larger than the air outlet opening 23'.
  • This embodiment has the advantage that the air flow entering the chamber 25 through the air inlet opening 23 can not escape from the chamber unhindered or unbraked without whirling up the powder contained therein and accompanying it.
  • the flow path through the chamber can also be influenced by varying the bore profiles in the air inlet and outlet openings 23, 23 '.
  • FIG. 6a and b An alternative powder container 2 can be seen in Fig. 6a and b, in which the wall 21 is not continuous: At the end facing away from the actuator 22 end, the wall 21 in tines 21 'over. These tines 21 'provide in certain embodiments of the powder inhaler or certain production variants, which will be explained later, that the powder container is not blocked by a powder dose when installed in the receiving cavity or during the transfer to the release position, which in the chamber or the receiving cavity is present. Furthermore, this way material can be saved.
  • Fig. 6b also shows an alternative actuator 22, which is designed here as a cock with two wings 24 '.
  • these wings 24 ' can also serve as a marker to indicate to the user, whether the powder container is in lock or release position.
  • FIG. 7 shows the powder container 2 from FIG. 6b arranged in the receiving cavity of an air duct housing 3 in the release position, in which the air outlet opening 23 'is aligned with the air outlet opening 37' of the air duct housing 3 and, correspondingly, the air inlet opening 23 is aligned with the air inlet opening of the air inlet.
  • the wings 24 ' are perpendicular to the axis defined by the air duct.
  • the orientation of the vanes can also be chosen so that it coincides with the axis defined by the air duct in the release position. From the illustration in FIG. 7 it is also clear that only the tines 21 'of the powder container 2 make contact with the bottom 32 "of the receiving cavity of the air channel housing 3.
  • FIGS. 8 and 9 each show an air duct housing 3, with both substantially identical with air inlet 31 and air outlet 33 except for the design of the receiving cavity 32. Also, the upper edge 35 of the receiving cavity 32 is formed in both cases with the counter-stop 35 'for the stop 22' of the powder container. While the bottom 32 "of the receiving cavity 32 is closed in Figure 8, the variant of Figure 9 has a hinged lid 38 for closing the receiving cavity 32 at the lower end Cover 38 is connected via a film hinge 38 "with the air duct housing 3, which can thus be made in one piece. Furthermore, a plug portion 38 'is seen extending from the lid 38 and sealing the lower opening of the receiving cavity 32 can close.
  • locking means may be provided on the lid 38 and the lower opening of the receiving cavity 32, here in the form of a latching recess 39 in the plug section 38 'and one extending from the inner wall of the receiving cavity 32 latching tongue 39 '.
  • FIG. Fig. 10a shows a section of the air duct housing with the receiving cavity 32, the lower opening is closed with the lid 38.
  • the powder container is arranged in the locked position.
  • a cross-sectional view at the level of the receiving cavity 32 is shown with the lid open in Fig. 10c and with the lid closed in Fig. 10b.
  • Detail section A with latching tongue 39 'and locking recess 39 on the inner wall of the receiving cavity 32 and the plug portion 38' is in Fig.
  • FIG. 10e and detail B with the annular bead 21 "on the outer surface of the wall 21 in engagement in a corresponding annular groove 35" in the Inner wall of the receiving cavity 32 can be seen in Fig. 10f.
  • Fig. 10d shows in cross section the powder container 2 in the release position.
  • 11 to 18 show different powder containers 2 with a circular cylindrical wall 21, which have a knurling wheel as the actuating element 22, and thus can be provided both for rotational and translational movement in the receiving cavity.
  • a knurling wheel as the actuating element 22
  • all variations shown may also be connected in conjunction with a tap as an actuator in a powder container or a deviating from the circular cylinder wall.
  • 11a and b illustrate a first variant of a powder container 2 in which a circular cylindrical wall 21 with air inlet and outlet openings 23, 23 'surrounds the chamber 25.
  • the stop 22' At the knurled wheel 22 directly adjoins the stop 22 'in the axial direction - in the case of a cock as seen in Fig. 6b, the stop 22' can also be offset from the actuator 22.
  • a loose deagglomerator 26 ' examples of which are shown in FIG.
  • Integral air swirling structures 26 which are fabricated integrally with the powder container 2 and also serve to enhance deagglomeration and dispersion of the powder, are shown in bottom view and longitudinal sectional view, respectively, of FIGS. 12-18.
  • the Heilverwirbelungs- or air deflection structures 26 may be baffle, helical or spiral and / or columnar structures, extending from the inner wall of the chamber 25 on the actuating element 22 mainly in the longitudinal direction to a through the Lucasein- and outlet opening 23,23 'axis defined away.
  • Fig. 19 shows a powder container 2, which differs from the powder container
  • Fig. 11 has a cylindrical wall 21 with hexagonal cross-section, and therefore for translational mobility of the powder container 2 in a correspondingly shaped receiving cavity 32 of an air duct housing 3, as seen in Fig. 20, is provided.
  • corresponding locking means on the wall 21 of the powder container 2 and 32 are provided in the inner wall of the receiving cavity, which is a snap in the locked position and optionally also allow a second engagement in the release position.
  • the powder container 2 is not yet fully inserted, whereby here the blocking position is reached, in which the air outlet opening 37 of the air duct housing 3 (and correspondingly, of course, the corresponding air inlet opening) are closed by a continuous wall section of the wall 21.
  • the opening of the receiving cavity 32 which is not closed by the powder container 2, is closed by a separate lid 4 or a sealing film 4.
  • FIGS. 21 and 22 illustrate two variants of a powder container 2, which has more than one chamber 25, in each of which there is a powder dose.
  • the two chambers 25 are arranged in the axial direction separated by the knurling wheel-like actuating means 22.
  • the filling opening 25 'and the air inlet and outlet openings 23, 23' of the chamber 25, which is not arranged in the receiving cavity of an air duct housing are closed.
  • both filling openings 25 'and the respective air inlet and outlet openings 23, 23' can be closed, so that the powder container 2 can also be stored separately from the air channel housing.
  • closure of the filling opening unopenable, z. B. by gluing or sealing can be designed, the Lucasein- and -auslassö réelleen 23,23 'must be closed with closure means that open, for example, shear or peel, preferably by the movement in the receiving cavity in the transfer of the Lock in the release position.
  • each chamber 25 in FIG. 22 is arranged adjacent to one another axially, with each chamber 25 having associated air inlet and outlet openings 23, 23 '.
  • the air inlet and outlet openings 23, 23 'of each chamber 25 are arranged rotationally symmetrically on a secant parallel to the dividing wall 25 ".
  • a multiple duct cartridge as in Fig. 22 requires an air duct housing with air inlet and outlet ports respectively offset from the centerline , Theoretically, more than two such adjacent chambers are conceivable, but the Heilein- and -auslassö réelleen 23,23 'together in a corresponding manner, which would then make a corresponding design of the air duct housing would be required.
  • the air outlet 33 shaped as a mouthpiece has an outlet contour 36 deviating from the other examples.
  • the outlet section 33 "expands significantly, which leads to a slowing down of the air flow with the associated spacer effect after the acceleration due to the narrow sections 31", 33 'adjoining the receiving cavity 32.
  • various variants for the production of a powder inhaler according to the invention are disclosed. All have in common that both the powder container 2 and the air duct housing 3 can be made by injection molding of plastic.
  • the powder container is placed in the receiving cavity of the air duct housing in the blocking position before or after a powder dose and possibly also a loose deagglomerator have been filled into the powder container or the receiving cavity.
  • the procedure here is also dependent on the variant of the air duct housing, depending on whether or not its receiving cavity has a bottom.
  • the illustrated variants are only to be understood as examples and not exclusively.
  • FIG. 24 shows a powder container 2 in which, after filling with a powder dose (not shown) and in this example with a loose deagglomerator 26 ', the filling opening 25' is provided with a seal 28 and the air inlet and outlet openings 23, 23 '. be closed with a closure means 27. Since such powder containers 2 can be stored separately from an air duct housing, this variant is suitable for multiple use of the air duct housing. Since the filling opening of the powder container 2 is closed by the seal, can be dispensed with the associated air duct housing on the bottom of the receiving cavity. If the seal 28 is also transparent, this method can also be checked after application if the powder dose has been completely inhaled.
  • the closure means may, for example, be a molded or otherwise applied plastic or elastomeric layer which is present in or above the openings 23, 23 'and, in a preferred embodiment, may easily project beyond the wall 21. These nipples can then be guided in corresponding grooves of the receiving cavity of the air duct housing during insertion of the powder container in the receiving cavity in the locked position. These grooves terminate at predetermined locations, so that upon movement of the powder container from the blocking to the release position, the sealing layer is pushed away or sheared off and so the openings 23,23 'are exposed.
  • a powder inhaler 1 is shown, in which the filling opening of the powder container 2 and the receiving cavity of the air duct housing 3 are closed by a separate cover 4, which can be glued, sealed or welded, for example.
  • This powder inhaler can be produced as a disposable article inexpensively with little material in a 2k injection molding process.
  • the powder container 2 is injection molded by plastic injection molding and in the next step the air duct housing 3 to the positioned in the blocking position powder container 2, wherein the filling opening of the powder container 2 and the receiving cavity 32 is left open at this point.
  • the powder dose 10 possibly also a loose disagglomerator
  • the air duct housing 3 can also be designed according to the embodiment of FIG. 9 with the integrally hinged lid.
  • a separately manufactured powder container in which the air inlet and outlet openings can be closed or can be closed with an open closure means, can be arranged in the blocking position in the receiving cavity of a powder inhaler that is open on both sides in order to pass through the open receiving cavity and to fill the fill port with the powder dose (and optionally a loose deagglomerator). Subsequently, the opening of the receiving cavity and thus the filling opening are sealed or closed with the hinged or a separate lid.
  • FIG. 26 illustrates a production variant of a powder inhaler according to the invention, in which first the powder container 2 is filled with the powder dose 10 (and optionally a loose deagglomerator). The powder container 2 is then placed in the blocking position with the open filling opening 25 'in the receiving cavity 32 of the air duct housing 3, wherein the bottom 32 "of the receiving cavity 32 closes the chamber 25.
  • the powder dose 10 in the with the Bottom 32 "unilaterally closed receiving cavity 32 of the air duct housing 3 is filled, whereupon the powder container 2 is arranged in the blocking position in the receiving cavity 32.
  • powder containers are suitable with a wall 21 which ends in tines 21 ', as described in connection with FIGS. 6 and 7, since the Prongs 21 'prevent blocking during insertion and movement of the powder container in the receiving cavity.
  • Fig. 27 the preparation and commissioning of a Pulverinhalators invention is indicated, in which the wall 21 of the powder container 2 and, correspondingly, the receiving cavity of the air duct housing 3 has a hexagonal cross-section.
  • the filling of the powder container 2 with the powder dose 10 can take place before or after the powder container 2 is arranged in the receiving cavity 32 in the blocking position, before the receiving cavity 32 is closed with the separate lid 4 (FIGS. 27a and c).
  • Fig. 27b illustrates in cross-sectional view the blocking position in which the powder container 2 is not yet completely inserted into the receiving cavity, so that the air outlet 23 'of the powder container 2 is closed by a closed wall portion of the receiving cavity.
  • Fig. 27b illustrates in cross-sectional view the blocking position in which the powder container 2 is not yet completely inserted into the receiving cavity, so that the air outlet 23 'of the powder container 2 is closed by a closed wall portion of the receiving cavity.
  • the powder inhaler may be designed for multiple use or as a disposable item.
  • Disposable products may be preferred in the medical field because they provide the patient and physician with a high degree of safety in terms of functionality and sterility.
  • the use of disposable articles can minimize the risk of cross-contamination or infection transmission.
  • no functional restrictions due to signs of wear or contamination will occur.
  • due to the simple structure easily cleaned air duct housing can also be used several times with disposable powder containers - if its openings are closed or sealed - are used.
  • a multiple use of an air duct housing z. B. with hinged lid be more useful than that of an air duct housing in which therackavtician is sealed.
  • a wall with tines (as shown in FIGS. 6 and 7) can be used instead of a continuous wall to save material, as there the Kam- Mer 25 is limited not only by the wall 21 of the powder container 2 but also by the inner wall of the receiving cavity 32.
  • both the integral air swirling structures 26 and the loose deagglomerators provide for deagglomeration, especially by impact of the fluid being swirled on the structure.
  • the deagglomerators 26 'shown there are essentially spherically shaped, but it is also possible to use regularly or irregularly polyhedral shaped deagglomerators.
  • such a deagglomerator 26 serves to desaggregate, comminute and possibly also mix the powder - for example if a powder mixture is present there.
  • a deagglomerator 26 ' In order for such a deagglomerator 26 'to remain in the chamber 25 during the application of the powder inhaler, it is dimensioned to be larger than the air inlet and outlet openings 23, 23' of the powder container 2. Further, in order not to block the air outlet opening 23 'of the powder container 3 as a result of the air flow generated by the inhalation of the user, the deagglomerator 26' is not solid, but designed with air passages.
  • 29a and b are designed as hollow spheres with symmetrically arranged openings, which are slot-like in FIG. 29a and round in FIG. 29b.
  • the deagglomerator 26 'of FIG. 29c is also based on a spherical body, but is provided with asymmetrical openings, as can be seen in the side view in FIG. 29d.
  • a so asymmetrically designed deagglomerator 26 ' is carried around in the powder container in the air stream "staggering" and thereby provides for additional turbulence.
  • FIG. 30 shows an embodiment of a powder inhaler according to the invention, in which the air inlet and outlet openings 23, 23 'and the filling opening of the powder container 2 are closed by a sleeve 29 closed on one side.
  • the wall 21 of the powder container 2 and the sleeve 29 are formed coordinated and dimensioned so that the wall 21 is exactly received in the sleeve 29, as seen in Fig. 30a, or conversely, the sleeve 29 can be accommodated exactly within the wall 21 (not shown).
  • the sleeve 29 has in the lateral surface openings 29 'and on the bottom surface fitting or locking elements 29 ", which in arrangement of the sleeve 29 in the receiving cavity 32 of the air duct housing 3 in such a manner with counter-pass or locking means of the air duct housing 3 (not shown) engage (key-lock principle) that the openings 29 ', which are provided in the lateral surface of the sleeve 19 in position and dimensioning accordingly , align with the air inlet and outlet openings of the air duct housing 3.
  • the sleeve 29 is shown in the position in which it can engage with its mating elements 29 "when placed in the receiving cavity 32 with the corresponding Gegenpasslementen so that the openings 29 'the air passage from the air inlet 31 to the air outlet 33rd
  • the powder container 2 shown in the blocking position is transferred to the sleeve 29 by rotating by 90 ° (clockwise in this embodiment) in the release position in which the stopper 22 'of the powder container 2 to the counter-stop 35' comes to rest and the air inlet and outlet openings 23, 23 'are aligned with the openings 29' in the sleeve 29 and the air inlet and outlet openings of the air duct housing 3.
  • this embodiment of the powder container closed with the sleeve can be used as a disposable item, it is preferred Reusable designed, as not only the air duct housing reuse enden, probe Also simply remove the powder container emptied after use, refill it and close it again by means of the sleeve.
  • FIG. 31 a) to g) shows a further alternative embodiment of a powder inhaler 1 according to the invention, in which both the mouth outlet 33 and the air inlet 31 are formed flattened.
  • the cross-section of air inlet 31 and outlet 33 has the shape of a rounded rectangle, as can be seen from the views c) and d).
  • the plan view in b) the curved course of the air ducts from the air inlet to the receiving cavity and from there to the air outlet is shown in dashed lines.
  • the taper or expansion are continuous, but with different slopes in the course of the sections 31 ', 31 ", 33', 33".
  • FIGS. 31 e) to f) show the filling, storage and use of this powder inhaler which, like the exemplary embodiment in FIG. 30, is equipped with an additional sleeve 29.
  • a powder inhaler has an air duct housing 3 according to the example shown in Fig. 31, in which a powder container 2 is accommodated, which is not closed by a sleeve 29, but by another of the embodiments described above.
  • Fig. 32 shows an alternatively manufactured air duct housing 3, which consists of two parts 3a, 3b, which are joined together, for example, folded to form the air duct housing.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

La présente invention concerne un inhalateur à poudre (1), constitué par un logement (3) de canal à air présentant une cavité de réception (32), dans laquelle est disposé un récipient à poudre (3), le récipient à poudre (2) présentant au moins une chambre (25) destinée à recevoir une dose de poudre (10). La chambre est délimité par une paroi (21) présentant au moins une ouverture (23) d'entrée d'air et au moins une ouverture (23') de sortie d'air et étant formée et dimensionnée conformément à la cavité de réception (32) du logement (3) de canal à air. Le logement (3) de canal à air délimite au moins un canal à air, qui relie une entrée d'air (31) à la cavité de réception (32) et la cavité de réception (32) à une sortie d'air (33), réalisée sous forme d'embout nasal ou buccal. Le logement (3) de canal à air est réalisé de manière immobile, présentant l'entrée d'air (31) et la sortie d'air (33) en des extrémités mutuellement opposées et le canal à air, l'entrée d'air (31) et la sortie d'air (33) se situant sur un axe. Le récipient à poudre (2) présente un élément d'actionnement (22) qui est disposé de manière adjacente à au moins une chambre (25). A l'aide de l'élément d'actionnement, le récipient à poudre (2) peut être amené d'une position de blocage, dans laquelle au moins une section fermée de la paroi (21) du récipient à poudre (2) forme un barrage dans le canal à air entre l'entrée d'air (31) et la sortie d'air (33) du logement (3) de canal à air, dans une position de libération, dans laquelle une voie fluidique est libérée, qui s'étend à partir de l'entrée d'air (31) à travers le canal à air du logement (3) de canal à aitre, à travers l'ouverture (23) d'entrée d'air, la chambre (25) et l'ouverture (23') de sortie d'air du récipient à poudre (2), et à travers le canal à air à la sortie d'air (33) du logement (3) du canal à air. En outre, l'invention concerne un récipient à poudre (2), un logement (3) de canal à air ainsi qu'une utilisation d'un inhalateur à poudre (1).
PCT/EP2016/000080 2015-01-19 2016-01-19 Inhalateur à poudre, ses modules, son récipient à poudre et son logement de canal à air ainsi qu'utilisation de l'inhalateur à poudre WO2016116267A1 (fr)

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DE102015000351.8A DE102015000351B3 (de) 2015-01-19 2015-01-19 Pulverinhalator,dessen Baueinheiten Pulverbehältnis und Luftkanalgehäuse sowie Verwendung des Pulverinhaltor
DE102015000351.8 2015-01-19

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KR20210117265A (ko) * 2019-01-14 2021-09-28 필립모리스 프로덕츠 에스.에이. 건조 분말 흡입기 장치
CN109966603B (zh) * 2019-03-05 2021-07-02 董艳 一种用于吸入治疗的雾化给药护理装置

Citations (5)

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Publication number Priority date Publication date Assignee Title
US3938516A (en) * 1975-01-13 1976-02-17 Syntex Puerto Rico, Inc. Inhalation device
US5337740A (en) * 1991-08-01 1994-08-16 New England Pharmaceuticals, Inc. Inhalation devices
US7305986B1 (en) * 1999-07-23 2007-12-11 Mannkind Corporation Unit dose capsules for use in a dry powder inhaler
WO2009121020A1 (fr) * 2008-03-27 2009-10-01 Mannkind Corporation Système d’inhalation de poudre sèche
WO2014012069A2 (fr) * 2012-07-12 2014-01-16 Mannkind Corporation Systèmes et procédés de libération de médicament en poudre sèche

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Publication number Priority date Publication date Assignee Title
DE102006006647B3 (de) * 2006-02-14 2007-01-18 Braunform Gmbh Vorrichtung zum Inhalieren eines in einer Kapsel sich befindenden Pulvers

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3938516A (en) * 1975-01-13 1976-02-17 Syntex Puerto Rico, Inc. Inhalation device
US5337740A (en) * 1991-08-01 1994-08-16 New England Pharmaceuticals, Inc. Inhalation devices
US7305986B1 (en) * 1999-07-23 2007-12-11 Mannkind Corporation Unit dose capsules for use in a dry powder inhaler
WO2009121020A1 (fr) * 2008-03-27 2009-10-01 Mannkind Corporation Système d’inhalation de poudre sèche
WO2014012069A2 (fr) * 2012-07-12 2014-01-16 Mannkind Corporation Systèmes et procédés de libération de médicament en poudre sèche

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