WO2004041336A1 - Inhalation therapy device - Google Patents

Inhalation therapy device Download PDF

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Publication number
WO2004041336A1
WO2004041336A1 PCT/EP2003/012404 EP0312404W WO2004041336A1 WO 2004041336 A1 WO2004041336 A1 WO 2004041336A1 EP 0312404 W EP0312404 W EP 0312404W WO 2004041336 A1 WO2004041336 A1 WO 2004041336A1
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WO
WIPO (PCT)
Prior art keywords
membrane
inhalation
aerosol
valve
mixing chamber
Prior art date
Application number
PCT/EP2003/012404
Other languages
German (de)
French (fr)
Inventor
Thomas Gallem
Markus Urich
Uwe Hetzer
Original Assignee
Pari GmbH Spezialisten für effektive Inhalation
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 Pari GmbH Spezialisten für effektive Inhalation filed Critical Pari GmbH Spezialisten für effektive Inhalation
Publication of WO2004041336A1 publication Critical patent/WO2004041336A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0085Inhalators using ultrasonics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0013Details of inhalators; Constructional features thereof with inhalation check valves
    • A61M15/0015Details of inhalators; Constructional features thereof with inhalation check valves located upstream of the dispenser, i.e. not traversed by the product
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0018Details of inhalators; Constructional features thereof with exhalation check valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20Valves specially adapted to medical respiratory devices
    • A61M16/201Controlled valves
    • A61M16/206Capsule valves, e.g. mushroom, membrane valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20Valves specially adapted to medical respiratory devices
    • A61M16/208Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves

Definitions

  • the invention relates to an inhalation therapy device with an aerosol membrane generator and a mixing chamber and an inhalation valve.
  • Inhalation therapy devices of this type can be used to nebulize medicated liquids, liquid medications or other therapeutically usable liquids, for example salt solutions, in order to provide the patient with an aerosol for inhalation.
  • Vibration generator is set in vibration, whereby a liquid present on one side of the membrane is atomized through the membrane and released into a mixing chamber.
  • the aerosol mixes with ambient air during the inhalation process, which is fed to the mixing chamber through an annular gap formed around a liquid storage container.
  • a flat circular inhalation valve is provided in the annular gap, which releases the annular gap during the inhalation phase and closes it during the exhalation phase.
  • the problem to be solved by the invention is to provide an inhalation therapy device in which the inhalation valve is designed in such a way that the risk of contamination of the aerosol membrane generator by the patient's breathing air during the exhalation phases is reduced.
  • Liquid storage container into which a medicinal liquid can be filled, with a membrane which is connected on one side to the liquid container in such a way that one in the
  • Liquid reservoir filled liquid comes into contact with one side of the membrane, and with a vibration generator, through which the membrane can be set in vibration, so that one in the
  • Liquid reservoir filled liquid is atomized through openings in the membrane on the other side of the membrane to form an aerosol, a mixing chamber into which the aerosol membrane generator generates the aerosol, and an inhalation valve which allows the inflow of ambient air into the mixing chamber during inhalation phases and during exhalation phases prevents the aerosol from escaping from the mixing chamber, which forms a wall section of the mixing chamber which has a funnel-like area, the tapering end of which
  • Valve opening includes and extends to the aerosol membrane generator, so that an edge surrounding the valve opening in the rest position of the inhalation valve on a surface of the aerosol membrane generator is arranged surrounding the membrane.
  • the funnel-like design of the valve according to the invention has the effect that, on the one hand, a dimensionally stable and flexible valve element provides the function as an inhalation valve and, on the other hand, a favorable flow of the supply air is achieved, since the valve opening surrounds the membrane and thus the supply air the aerosol it produces.
  • the design which resembles a funnel, ensures that the aerosol is deposited to a lesser extent in the mixing chamber during inhalation phases.
  • the inhalation valve By designing the inhalation valve as a wall section, it also defines the dimensions of the mixing chamber, which immediately minimizes the space that comes into contact with aerosol.
  • the funnel-like design according to the invention in the form of a wall section avoids an area for the inhalation valve which is to be provided in addition to the mixing chamber and then also comes into contact with aerosol. The cleaning of the therapy device is correspondingly easier.
  • the funnel-like area of the inhalation valve is rounded, conical-flat, stepped or meandering.
  • the edge of the valve opening advantageously has a thickening or a bead all around.
  • the inhalation valve has an edge section next to the valve element.
  • the edge area is preferably for holding the Inhalation valve, in particular designed for clamping between the aerosol generator and the mixing chamber.
  • Inhalation valve preferably made of an elastic material.
  • FIG. 1A shows a sectional view of an inhalation device according to the invention with the inhalation valve closed;
  • IB is a sectional view of an inhalation device according to the invention with the inhalation valve open;
  • 3A and 3B are perspective views of an inhalation valve according to the invention.
  • FIGS. 1A and IB show an exemplary embodiment of an inhalation therapy device 1 according to the invention, which has an aerosol membrane generator 2 and a mixing chamber 3.
  • the two components are designed as separate units, which are connected to one another in a suitable manner in the region of the inhalation valve, so that both components as functional unit can be handled safely.
  • the aerosol generator 2 of the exemplary embodiment from FIG. 1A comprises a liquid storage container 4, into which a medicament-containing liquid 5 can be filled, and a membrane 6, which seals off the liquid storage container 4 on an open surface.
  • the membrane 6 is connected on one side to the liquid container 4 in such a way that the liquid 5 filled into the liquid storage container touches one side of the membrane 6.
  • a vibration generator 7, 'for example, a piezo element is arranged to vibrate through which the membrane 6 when the vibration generator is driven. 7
  • Vibration generator 7 is designed to be rotationally symmetrical, so that the vibration generator 7 concentrically surrounds the membrane.
  • the membrane 6 If the vibration generator 7 is excited, for example an alternating voltage is applied to the piezo element, the membrane 6 is set in vibration, so that the liquid 5 which is filled into the liquid reservoir and is present on the membrane passes through openings in the membrane to the other side of the membrane Membrane promoted and atomized there to an aerosol. The aerosol is released into the mixing chamber 3.
  • the vibration generator 7 for example an alternating voltage is applied to the piezo element, the membrane 6 is set in vibration, so that the liquid 5 which is filled into the liquid reservoir and is present on the membrane passes through openings in the membrane to the other side of the membrane Membrane promoted and atomized there to an aerosol.
  • the aerosol is released into the mixing chamber 3.
  • a mouthpiece 10 is also provided, which in the example shown is formed in one piece with the mixing chamber 3, but which, in a modified embodiment, can also be designed to be separable from the mixing chamber 3. Via the mouthpiece 10, the patient inhales that generated by the aerosol membrane generator 2 and into the mixing chamber 3 dispensed aerosol when inhaled through the mouthpiece.
  • an inhalation valve 20 is provided for controlling / checking the supply air, which in the inhalation phases detects the inflow of
  • Ambient air allows into the mixing chamber, as shown in FIG. IB, but which closes the supply air channels 9 in exhalation phases such that the exhaled breathing air does not flow through the supply air channels 9, as shown in FIG. 1A.
  • the inhalation valve 20 according to the invention thus prevents
  • the aerosol with the respiratory air by the air supply channels 9 from the mixing chamber and that breath air into the supply air ducts passes'. 9
  • the area around the liquid container 4 in the aerosol generator 2 in which there are often also other components, for example electrical connections for controlling the piezo crystal is protected from breathing air and thus from contaminants which enter the therapy device with the breathing air .
  • the inhalation valve according to the invention thus protects the interior of the aerosol generator during the exhalation phases.
  • the exhaled air is led out of the mixing chamber 3 or the mouthpiece 10 in a different way, for example via the known mouthpiece valve 32, 321, 322, the functioning of which is not discussed in detail here.
  • the valve element 21 of the inhalation valve 20 forms a wall section of the mixing chamber 3 in which it is open Closing wall area of the mixing chamber 3 supplemented.
  • the valve element 21 of the inhalation valve 20 comprises a valve opening 22, which is formed by the valve element 21, as can be seen in FIGS. 1A and IB, tapering at least in regions like a funnel.
  • a sufficiently dimensionally stable valve element 21 is created through the funnel-like region 23 of the inhalation valve 20, through the opening 22 of which the supply air can flow into the mixing chamber 3 when the patient inhales.
  • valve element 21 which resembles a funnel, is deflected out of the rest position, into which it always returns automatically due to its dimensional stability and elasticity, and, as shown in FIG. 1B, releases a gap through which the supply air passes the inhalation valve 20 can.
  • the gap is formed in the immediate vicinity of the membrane 6 and surrounds it, flow guidance of the supply air that supports aerosol generation is achieved. This is because the supply air to a certain extent encloses the aerosol emitted by the membrane 6 and thus reduces the risk that the aerosol will quickly hit a wall of the mixing chamber 3 and separate there. This is also a particular advantage of the inhalation valve according to the invention.
  • valve element 21 rests on a surface of the aerosol generator 2, as shown in FIG. 1A, so that there is no gap between the aerosol generator and the valve element 21.
  • the edge 24 of the valve opening 22 surrounds the membrane 6 of the aerosol generator, the valve opening 22 preferably being circular, in particular if the membrane 6 and the vibration generator 7 are also circular.
  • 1A and IB thus show that the tapering region 23 of the valve element 21 extends according to the invention to the aerosol membrane generator 2 in such a way that the edge 24 surrounding the opening is arranged on a surface of the aerosol generator 2 and surrounds the membrane ⁇ .
  • the surface of the aerosol generator 2 thus forms, as it were, that shown in FIG. 1A
  • valve element 21 has a circumferential bulge or thickening 24 at the edge of the valve opening 22, as a result of which the opening edge is strengthened and the dimensional stability is increased.
  • this design of the edge of the valve opening 22 makes it possible, in the case of the normally occurring breathing air flows, to reliably prevent the valve element 21 from being deflected by the breathing air flow to such an extent that it extends completely into the mixing chamber 3 and thereby assumes a new, dimensionally stable position from which it does not return to the rest position shown in FIG. 1A.
  • the bead 24 on the edge of the valve opening 22 reduces the risk that this area of the valve element 21 is damaged.
  • the funnel-like shape of the valve element 21 according to the invention can be achieved by a rounded wall profile; however, other wall shapes are also conceivable, for example the conical, flat profile shown in FIG. 2A, the stepped profile shown in FIG. 2B or the meandering profile shown in FIG. 2C.
  • the inhalation valve 20 is between a wall section 31 of the aerosol generator 2 and a wall section 31 of the mixing chamber 3 and preferably held, for example clamped, in such a way that the inhalation valve 20 is securely fixed and its valve opening 22 is exactly positioned.
  • the inhalation valve 20 has an outer edge section 25 for the
  • FIGS. 1A and IB are also particularly advantageous because the inhalation valve 20 is used to seal the connection point between the aerosol generator 2 and the mixing chamber 3.
  • the edge section 25 of the inhalation valve 20 is adapted to the end cross sections of the aerosol generator 2 and the mixing chamber 3.
  • Figures 3A and 3B show that the adjustment of the
  • Edge section 25 can go very far, but a transition to the funnel-like valve element 21 according to the invention with valve opening 22 can always be easily created.
  • this type of adaptation ensures that the material of the inhalation valve 20 which is fundamentally suitable for sealing purposes is also used for sealing the transition between the aerosol generator 2 and the mixing chamber 3. It also follows that the inhalation valve 20 according to the invention is preferably formed in one piece.

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  • Health & Medical Sciences (AREA)
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Abstract

The inhalation therapy device comprises an aerosol generator (2) and a mixing chamber (3). The introduction of atmospheric air is achieved by means of ventilation channels (9), controlled by an inspiration valve (20), comprising a funnel-like region (23) and a valve opening (22). The valve opening (22) surrounds the membrane (6) of the aerosol generator (2), whereby the edge (24) of the valve rests on a surface of the aerosol generator (2).

Description

Inhalationstherapievorrichtung Inhalation therapy device
Die Erfindung betrifft eine Inhalationstherapievorrichtung mit einem Aerosolmembrangenerator und einer Mischkammer sowie einem Einatemventil.The invention relates to an inhalation therapy device with an aerosol membrane generator and a mixing chamber and an inhalation valve.
Mit Inhalationstherapievorrichtungen dieser Art können medikamenthaltige Flüssigkeiten, flüssige Medikamente oder andere therapeutisch einsetzbare Flüssigkeiten, beispielsweise Salzlösungen, vernebelt werden, um dem Patienten ein Aerosol für die Inhalation darzubieten.Inhalation therapy devices of this type can be used to nebulize medicated liquids, liquid medications or other therapeutically usable liquids, for example salt solutions, in order to provide the patient with an aerosol for inhalation.
DE 199 53 317 A beschreibt eine derartige Inhalationstherapievorrichtung mit einem Membranaerosolgenerator, dessen Membran durch einenDE 199 53 317 A describes such an inhalation therapy device with a membrane aerosol generator, the membrane of which is penetrated by a
Schwingungsgenerator in Schwingungen versetzt wird, wodurch eine auf der einen Seite der Membran anstehende Flüssigkeit durch die Membran hindurch vernebelt und in eine Mischkammer hinein abgegeben wird. In der Mischkammer durchmischt sich das Aerosol während des Einatmungsvorgangs mit Umgebungsluft, die der Mischkammer durch einen um einen Flüssigkeitsvorratsbehälter gebildeten Ringspalt zugeführt wird. In dem Ringspalt ist ein ebenes kreisförmiges Einatemventil vorgesehen, das den Ringspalt während der Einatemphase freigibt und während der Ausatemphase verschließt .Vibration generator is set in vibration, whereby a liquid present on one side of the membrane is atomized through the membrane and released into a mixing chamber. In the mixing chamber, the aerosol mixes with ambient air during the inhalation process, which is fed to the mixing chamber through an annular gap formed around a liquid storage container. A flat circular inhalation valve is provided in the annular gap, which releases the annular gap during the inhalation phase and closes it during the exhalation phase.
Wenn bei dem bekannten Therapievernebler der Patient in die Vorrichtung hinein ausatmet, gelangt zwar ein großer Teil der Atemluft über ein in einem Mundstück der Vorrichtung vorgesehenes Ausatemventil unmittelbar in Umgebung, jedoch sind auch der Aerosolmembrangenerator und der Bereich des Flüssigkeitsvorratsbehälters einem Teil der Atemluft ausgesetzt. Es kommt auf diese Weise zu unerwünschten Verunreinigungen des Aerosolgenerators. Das von der Erfindung zu lösende Problem besteht vor dem Hintergrund dieses Standes der Technik darin, eine Inhalationstherapievorrichtung anzugeben, bei der das Einatemventil derart gestaltet ist, dass das Risiko einer Verunreinigung des Aerosolmembrangenerators durch die Atemluft des Patienten während der Ausatemphasen verringert ist.When the patient exhales into the device in the known therapy nebulizer, a large part of the breathing air gets directly into the environment via an exhalation valve provided in a mouthpiece of the device, but the aerosol membrane generator and the area of the liquid storage container are also exposed to part of the breathing air. This leads to undesirable ones Contamination of the aerosol generator. Against the background of this prior art, the problem to be solved by the invention is to provide an inhalation therapy device in which the inhalation valve is designed in such a way that the risk of contamination of the aerosol membrane generator by the patient's breathing air during the exhalation phases is reduced.
Dieses Problem wird gelöst durch eineThis problem is solved by a
Inhalationstherapievorrichtung mit einem Aerosolmembrangenerator, mit einemInhalation therapy device with an aerosol membrane generator, with a
Flüssigkeitsvorratsbehälter, in den eine medikamenthaltige Flüssigkeit einfüllbar ist, mit einer Membran, die auf einer Seite mit dem Flüssigkeitsbehälter derart in Verbindung steht, dass eine in denLiquid storage container into which a medicinal liquid can be filled, with a membrane which is connected on one side to the liquid container in such a way that one in the
Flüssigkeitsvorratsbehälter eingefüllte Flüssigkeit in Berührung mit einer Seite der Membran gelangt, und mit einem Schwingungsgenerator, durch den die Membran in Schwingungen versetzbar ist, so dass eine in denLiquid reservoir filled liquid comes into contact with one side of the membrane, and with a vibration generator, through which the membrane can be set in vibration, so that one in the
Flüssigkeitsvorratsbehälter eingefüllte Flüssigkeit durch Öffnungen der Membran hindurch auf der anderen Seite der Membran zu einem Aerosol zerstäubt wird, einer Mischkammer, in die hinein der Aerosolmembrangenerator das Aerosol erzeugt, und einem Einatemventil, das in Einatemphasen den Zustrom von Umgebungsluft in die Mischkammer zulässt und in Ausatemphasen das Austreten des Aerosols aus der Mischkammer verhindert, das einen Wandabschnitt der Mischkammer bildet, das einen trichterartig zulaufenden Bereich aufweist, dessen zulaufendes Ende eineLiquid reservoir filled liquid is atomized through openings in the membrane on the other side of the membrane to form an aerosol, a mixing chamber into which the aerosol membrane generator generates the aerosol, and an inhalation valve which allows the inflow of ambient air into the mixing chamber during inhalation phases and during exhalation phases prevents the aerosol from escaping from the mixing chamber, which forms a wall section of the mixing chamber which has a funnel-like area, the tapering end of which
Ventilöffnung umfasst und sich zum Aerosolmembrangenerator erstreckt, so dass ein die Ventilöffnung umschließender Rand in der Ruhelage des Einatemventils auf einer Oberfläche des Aerosolmembrangenerators die Membran umschließend angeordnet ist. Die trichterartige Gestaltung des Ventils gemäß der Erfindung bewirkt, dass einerseits ein formstabiles und flexibles Ventilelement die Funktion als Einatemventil bereitstellt und das andererseits eine günstige Strömungsführung der Zuluft erzielt wird, da die Ventilöffnung die Membran und damit die Zuluft das von ihr erzeugte Aerosol umgibt. Durch die einem Trichter ähnelnde Gestaltung wird somit erreicht, dass in Einatemphasen sich das Aerosol in geringerem Umfang in der Mischkammer niederschlägt.Valve opening includes and extends to the aerosol membrane generator, so that an edge surrounding the valve opening in the rest position of the inhalation valve on a surface of the aerosol membrane generator is arranged surrounding the membrane. The funnel-like design of the valve according to the invention has the effect that, on the one hand, a dimensionally stable and flexible valve element provides the function as an inhalation valve and, on the other hand, a favorable flow of the supply air is achieved, since the valve opening surrounds the membrane and thus the supply air the aerosol it produces. The design, which resembles a funnel, ensures that the aerosol is deposited to a lesser extent in the mixing chamber during inhalation phases.
Indem das Einatemventil als Wandabschnitt ausgebildet ist, legt es die Dimensionen der Mischkammer mit fest, wodurch unmittelbar eine Minimierung des mit Aerosol in Kontakt kommenden Raumes erzielt wird. Mit anderen Worten, durch die erfindungsgemäße trichterartige Gestaltung in Form eines Wandabschnitts wird ein Bereich für das Einatemventil vermieden, der zusätzlich zu der Mischkammer vorzusehen ist und dann auch mit Aerosol in Berührung kommt. Die Reinigung des Therapiegerät ist entsprechend einfacher.By designing the inhalation valve as a wall section, it also defines the dimensions of the mixing chamber, which immediately minimizes the space that comes into contact with aerosol. In other words, the funnel-like design according to the invention in the form of a wall section avoids an area for the inhalation valve which is to be provided in addition to the mixing chamber and then also comes into contact with aerosol. The cleaning of the therapy device is correspondingly easier.
In einer vorteilhaften Ausgestaltung ist der trichterartige Bereich des Einatemventils abgerundet, konisch-eben, stufig oder meanderförmig ausgestaltet ist.In an advantageous embodiment, the funnel-like area of the inhalation valve is rounded, conical-flat, stepped or meandering.
Zur Erhöhung der Formstabilität und zum Schutz des Ventils gegen Beschädigungen weist vorteilhafterweise der Rand der Ventilöffnung umlaufend eine Verdickung oder einen Wulst auf.To increase the dimensional stability and to protect the valve against damage, the edge of the valve opening advantageously has a thickening or a bead all around.
Damit das Einatemventil einfacher handhabbar und gegen Beschädigungen geschützt wird, weist das Einatemventil neben dem Ventilelement einen Randabschnitt auf. Der Randbereich ist vorzugsweise für die Halterung des Einatemventils, insbesondere für das Einklemmen zwischen dem Aerosolgenerator und der Mischkammer ausgestaltet.So that the inhalation valve is easier to handle and protected against damage, the inhalation valve has an edge section next to the valve element. The edge area is preferably for holding the Inhalation valve, in particular designed for clamping between the aerosol generator and the mixing chamber.
Um einerseits ausreichend formstabil und andererseits gleichzeitig ausreichend flexibel zu sein, ist dasIn order to be sufficiently dimensionally stable on the one hand and at the same time sufficiently flexible, that is
Einatemventil vorzugsweise aus einem elastischen Material hergestellt .Inhalation valve preferably made of an elastic material.
Die Erfindung wird im Folgenden anhand eines Ausführungsbeispiels und unter Bezugnahme auf dieThe invention is described below using an exemplary embodiment and with reference to FIG
Zeichnungen genauer erläutert. In den Zeichnungen zeigt:Drawings explained in more detail. In the drawings:
Fig. 1A eine geschnittene Ansicht einer erfindungsgemäßen Inhalationsvorrichtung mit geschlossenem Einatemventil;1A shows a sectional view of an inhalation device according to the invention with the inhalation valve closed;
Fig. IB eine geschnittene Ansicht einer erfindungsgemäßen Inhalationsvorrichtung mit geöffnetem Einatemventil;IB is a sectional view of an inhalation device according to the invention with the inhalation valve open;
Fig. 2A, 2B und 2C alternative Ausgestaltungen eines erfindungsgemäßen Einatemventils; und2A, 2B and 2C alternative configurations of an inhalation valve according to the invention; and
Fig. 3A und 3B perspektivische Ansichten eines erfindungsgemäßen Einatemventils .3A and 3B are perspective views of an inhalation valve according to the invention.
Die Figuren 1A und IB zeigen ein Ausführungsbeispiel eines erfindungsgemäßen Inhalationstherapiegerätes 1, -das einen Aerosolmembrangenerator 2 und eine Mischkammer 3 aufweist. In dem gezeigten Ausführungsbeispiel sind die beiden Komponenten als getrennte Einheiten ausgelegt, die im Bereich des Einatemventil miteinander auf geeignete Weise verbunden werden, so dass beide Komponenten als funktionsfähige Einheit sicher gehandhabt werden können.FIGS. 1A and IB show an exemplary embodiment of an inhalation therapy device 1 according to the invention, which has an aerosol membrane generator 2 and a mixing chamber 3. In the exemplary embodiment shown, the two components are designed as separate units, which are connected to one another in a suitable manner in the region of the inhalation valve, so that both components as functional unit can be handled safely.
Der Aerosolgenerator 2 des Ausführungsbeispiels aus Figur 1A umfasst einen Flüssigkeitsvorratsbehälter 4, in den eine medikamenthaltige Flüssigkeit 5 einfüllbar ist, und eine Membran 6, die den Flüssigkeitsvorratsbehälter 4 an einer geöffneten Fläche abschließt. Dadurch steht die Membran 6 auf einer Seite mit dem Flüssigkeitsbehälter 4 derart in Verbindung, dass die in den Flüssigkeitsvorratsbehälter eingefüllte Flüssigkeit 5 die eine Seite der Membran 6 berührt. An der Membran 6 ist ein Schwingungsgenerator 7,' beispielsweise ein Piezo-Element, angeordnet, durch den die Membran 6 in Schwingungen versetzt wird, wenn der Schwingungsgenerator 7 angesteuert wird. In dem hier gezeigten Ausführungsbeispiel sind Membran 6 undThe aerosol generator 2 of the exemplary embodiment from FIG. 1A comprises a liquid storage container 4, into which a medicament-containing liquid 5 can be filled, and a membrane 6, which seals off the liquid storage container 4 on an open surface. As a result, the membrane 6 is connected on one side to the liquid container 4 in such a way that the liquid 5 filled into the liquid storage container touches one side of the membrane 6. At the membrane 6 is a vibration generator 7, 'for example, a piezo element, is arranged to vibrate through which the membrane 6 when the vibration generator is driven. 7 In the embodiment shown here, membrane 6 and
Schwingungsgenerator 7 rotationssymmetrisch ausgelegt, so dass der Schwingungsgenerator 7 die Membran konzentrisch umgibt .Vibration generator 7 is designed to be rotationally symmetrical, so that the vibration generator 7 concentrically surrounds the membrane.
Wird der Schwingungsgenerator 7 angeregt, also beispielsweise das Piezo-Element mit einer Wechselspannung beaufschlagt, wird die Membran 6 in Schwingungen versetzt, so dass die in den Flüssigkeitsvorratsbehälter eingefüllte und an der Membran anstehende Flüssigkeit 5 durch Öffnungen in der Membran hindurch auf die anderen Seite der Membran gefördert und dort zu einem Aerosol zerstäubt wird. Das Aerosol wird in die Mischkammer 3 hinein abgegeben.If the vibration generator 7 is excited, for example an alternating voltage is applied to the piezo element, the membrane 6 is set in vibration, so that the liquid 5 which is filled into the liquid reservoir and is present on the membrane passes through openings in the membrane to the other side of the membrane Membrane promoted and atomized there to an aerosol. The aerosol is released into the mixing chamber 3.
Bei dem in Figur 1A gezeigten Ausführungsbeispiel ist ferner ein Mundstück 10 vorgesehen, das in dem gezeigten Beispiel einstückig mit der Mischkammer 3 ausgebildet ist, das aber in einer abgewandelten Ausführungsform auch von der Mischkammer 3 trennbar ausgestaltet werden kann. Über das Mundstück 10 inhaliert der Patient das von dem Aerosolmembrangenerator 2 erzeugte und in die Mischkammer 3 abgegebene Aerosol, wenn er durch das Mundstück einatmet.In the exemplary embodiment shown in FIG. 1A, a mouthpiece 10 is also provided, which in the example shown is formed in one piece with the mixing chamber 3, but which, in a modified embodiment, can also be designed to be separable from the mixing chamber 3. Via the mouthpiece 10, the patient inhales that generated by the aerosol membrane generator 2 and into the mixing chamber 3 dispensed aerosol when inhaled through the mouthpiece.
Während der Einatemphase strömt Umgebungsluft durch Zuluftkanäle 8, die in dem Aerosolmembrangenerator 2 ausgebildet sind, in das Therapiegerät und gelangt in die Mischkammer 3, wie insbesondere aus Figur IB ersichtlich ist; der Strömungsverlauf der Zuluft ist in Figur IB mit den Pfeillinien 9 angedeutet. Erfindungsgemäß ist zur Steuerung/Kontrolle der Zuluft ein Einatemventil 20 vorgesehen, das in Einatemphasen den Zustrom vonDuring the inhalation phase, ambient air flows through supply air channels 8, which are formed in the aerosol membrane generator 2, into the therapy device and reaches the mixing chamber 3, as can be seen in particular from FIG. 1B; the flow of the supply air is indicated in FIG. IB by the arrow lines 9. According to the invention, an inhalation valve 20 is provided for controlling / checking the supply air, which in the inhalation phases detects the inflow of
Umgebungsluft in die Mischkammer zulässt, wie Figur IB zeigt, das aber in Ausatemphasen die Zuluftkanäle 9 derart verschließt, dass die ausgeatmete Atemluft nicht durch die Zuluftkanäle 9 strömt, wie Figur 1A zeigt. Damit verhindert das erfindungsgemäße Einatemventil 20, dass inAmbient air allows into the mixing chamber, as shown in FIG. IB, but which closes the supply air channels 9 in exhalation phases such that the exhaled breathing air does not flow through the supply air channels 9, as shown in FIG. 1A. The inhalation valve 20 according to the invention thus prevents
Ausatemphasen das Aerosol mit der Atemluft durch die Zuluftkanäle 9 aus der Mischkammer transportiert wird und dass Atemluft in die Zuluftkanäle '9 gelangt. Dadurch wird in dem Aerosolgenerator 2 der Bereich um den Flüssigkeitsbehälter 4 herum, in dem sich oftmals auch andere Komponenten, beispielsweise elektrische Anschlüsse für die Ansteuerung des Piezo-Kristalls befinden, vor Atemluft und damit vor Verunreinigungen geschützt, die mit der Atemluft in das Therapiegerät gelangen. Somit schützt das erfindungsgemäße Einatemventil das Innere des Aerosolgenerators während der Ausatemphasen.Is transported exhalation phases, the aerosol with the respiratory air by the air supply channels 9 from the mixing chamber and that breath air into the supply air ducts passes'. 9 As a result, the area around the liquid container 4 in the aerosol generator 2, in which there are often also other components, for example electrical connections for controlling the piezo crystal, is protected from breathing air and thus from contaminants which enter the therapy device with the breathing air , The inhalation valve according to the invention thus protects the interior of the aerosol generator during the exhalation phases.
Die Ausatemluft wird auf andere Weise aus der Mischkammer 3 bzw. dem Mundstück 10 geführt, beispielsweise über das bekannte Mundstückventil 32, 321, 322, auf dessen Funktionsweise hier nicht näher eingegangen wird.The exhaled air is led out of the mixing chamber 3 or the mouthpiece 10 in a different way, for example via the known mouthpiece valve 32, 321, 322, the functioning of which is not discussed in detail here.
Erfindungsgemäß bildet das Ventilelement 21 des Einatemventils 20, wie in Figur 1A und IB gezeigt, einen Wandabschnitt der Misch ammer 3, in dem es einen offen Wandbereich der Mischkammer 3 verschließend ergänzt. Das Ventilelement 21 des Einatemventils 20 umfasst eine Ventilöffnung 22, die gebildet wird, indem das Ventilelement 21, wie aus Figur 1A und IB entnehmbar ist, zumindest bereichsweise sich trichterartig verjüngend ausgebildet ist. Durch den trichterartig zulaufenden Bereich 23 des Einatemventils 20 wird ein ausreichend formstabiles Ventilelement 21 geschaffen, durch dessen Öffnung 22 die Zuluft in die Mischkammer 3 strömen kann, wenn der Patient einatmet. Denn in den Einatemphasen wird das einem Trichter ähnelnde Ventilelement 21 aus der Ruhelage, in die es aufgrund seiner Formstabilität und Elastizität stets selbsttätig zurückkehrt, ausgelenkt und gibt, wie in Figur IB gezeigt ist, einen Spalt frei, durch den die Zuluft das Einatemventil 20 passieren kann.According to the invention, the valve element 21 of the inhalation valve 20, as shown in FIGS. 1A and IB, forms a wall section of the mixing chamber 3 in which it is open Closing wall area of the mixing chamber 3 supplemented. The valve element 21 of the inhalation valve 20 comprises a valve opening 22, which is formed by the valve element 21, as can be seen in FIGS. 1A and IB, tapering at least in regions like a funnel. A sufficiently dimensionally stable valve element 21 is created through the funnel-like region 23 of the inhalation valve 20, through the opening 22 of which the supply air can flow into the mixing chamber 3 when the patient inhales. Because in the inhalation phases, the valve element 21, which resembles a funnel, is deflected out of the rest position, into which it always returns automatically due to its dimensional stability and elasticity, and, as shown in FIG. 1B, releases a gap through which the supply air passes the inhalation valve 20 can.
Da der Spalt sich unmittelbar in der Nähe der Membran 6 und diese umgebend ausbildet, wird eine die Aerosolerzeugung unterstützende Strömungsführung der Zufluft erreicht. Denn die Zuluft umschließt gewissermaßen das von der Membran 6 abgegebene Aerosol und verringert so das Risiko, dass das Aerosol rasch auf eine Wand der Mischkammer 3 trifft und sich dort abscheidet. Auch hierbei handelt es sich um einen besonderen Vorteil des erfindungsgemäßen Einatemventils.Since the gap is formed in the immediate vicinity of the membrane 6 and surrounds it, flow guidance of the supply air that supports aerosol generation is achieved. This is because the supply air to a certain extent encloses the aerosol emitted by the membrane 6 and thus reduces the risk that the aerosol will quickly hit a wall of the mixing chamber 3 and separate there. This is also a particular advantage of the inhalation valve according to the invention.
In der Ruhelage liegt demgegenüber das Ventilelement 21 auf einer Oberfläche des Aerosolgenerators 2 auf, wie Figur 1A zeigt, so dass kein Spalt zwischen dem Aerosolgenerator und dem Ventilelement 21 vorhanden ist. Ferner umgibt in der Ruhelage der Rand 24 der Ventilöffnung 22 die Membran 6 des Aerosolgenerators, wobei die Ventilöffnung 22 vorzugsweise kreisförmig ausgestaltet ist, insbesondere wenn auch die Membran 6 und der Schwingungsgenerator 7 ebenfalls kreisförmig ausgelegt sind. Aus Figur 1A und IB ergibt sich somit, dass sich der zulaufende Bereich 23 des Ventilelements 21 erfindungsgemäß derart zum Aerosolmembrangenerator 2 erstreckt, dass der die Öffnung umschließende Rand 24 auf einer Oberfläche des Aerosolgenerators 2 die Membran β umschließend angeordnet ist.. Die Oberfläche des Aerosolgenerators 2 bildet somit gewissermaßen bei dem in Figur 1A gezeigtenIn the rest position, in contrast, the valve element 21 rests on a surface of the aerosol generator 2, as shown in FIG. 1A, so that there is no gap between the aerosol generator and the valve element 21. Furthermore, in the rest position, the edge 24 of the valve opening 22 surrounds the membrane 6 of the aerosol generator, the valve opening 22 preferably being circular, in particular if the membrane 6 and the vibration generator 7 are also circular. 1A and IB thus show that the tapering region 23 of the valve element 21 extends according to the invention to the aerosol membrane generator 2 in such a way that the edge 24 surrounding the opening is arranged on a surface of the aerosol generator 2 and surrounds the membrane β . , The surface of the aerosol generator 2 thus forms, as it were, that shown in FIG. 1A
Ausführungsbeispiel den Ventilsitz für das Ventilelement 21 des Einatemventils 20.Embodiment the valve seat for the valve element 21 of the inhalation valve 20th
In Figur 1A und IB ist ferner gezeigt, dass das Ventilelement 21 am Rand der Ventilöffnung 22 einen umlaufenden Wulst oder Verdickung 24 aufweist, wodurch der Öffnungsrand verstärkt und nebenbei die Formstabilität erhöht wird. Insbesondere ist es durch diese Gestaltung des Randes der Ventilöffnung 22 möglich, bei den normalerweise auftretenden Atemluftströmungen sicher zu verhindern, dass durch die Atemluftströmung das Ventilelement 21 soweit ausgelenkt wird, dass es sich vollständig in die Mischkammer 3 hinein erstreckt und dabei eine neue formstabile Lage einnimmt, aus der es nicht in die in Figur 1A gezeigte Ruhelage zurückkehrt. Gleichzeitig verringert der Wulst 24 am Rand der Ventilöffnung 22 das Risiko, dass dieser Bereich des Ventilelements 21 beschädigt wird.1A and IB also show that the valve element 21 has a circumferential bulge or thickening 24 at the edge of the valve opening 22, as a result of which the opening edge is strengthened and the dimensional stability is increased. In particular, this design of the edge of the valve opening 22 makes it possible, in the case of the normally occurring breathing air flows, to reliably prevent the valve element 21 from being deflected by the breathing air flow to such an extent that it extends completely into the mixing chamber 3 and thereby assumes a new, dimensionally stable position from which it does not return to the rest position shown in FIG. 1A. At the same time, the bead 24 on the edge of the valve opening 22 reduces the risk that this area of the valve element 21 is damaged.
Wie in Figur 1A und IB gezeigt, kann die trichterartige Form des erfindungsgemäßen Ventilelements 21 durch einen abgerundeten Wandverlauf erzielt werden; jedoch sind auch andere Wandformen denkbar, beispielsweise der in Figur 2A dargestellte konisch-ebene Verlauf, der in Figur 2B dargestellte stufige Verlauf oder der in Figur 2C dargestellte meanderförmige Verlauf.As shown in FIGS. 1A and IB, the funnel-like shape of the valve element 21 according to the invention can be achieved by a rounded wall profile; however, other wall shapes are also conceivable, for example the conical, flat profile shown in FIG. 2A, the stepped profile shown in FIG. 2B or the meandering profile shown in FIG. 2C.
Bei dem in Figur 1A und IB gezeigten Ausführungsbeispiel ist das Einatemventil 20 zwischen einem Wandabschnitt 31 des Aerosolgenerators 2 und einem Wandabschnitt 31 der Mischkammer 3 angeordnet und vorzugsweise derart gehaltert, beispielsweise eingeklemmt, dass das Einatemventil 20 sicher fixiert und dessen Ventilöffnung 22 exakt positioniert ist. Das Einatemventil 20 weist dazu einen äußeren Randabschnitt 25 auf, der für dieIn the exemplary embodiment shown in FIGS. 1A and IB, the inhalation valve 20 is between a wall section 31 of the aerosol generator 2 and a wall section 31 of the mixing chamber 3 and preferably held, for example clamped, in such a way that the inhalation valve 20 is securely fixed and its valve opening 22 is exactly positioned. The inhalation valve 20 has an outer edge section 25 for the
Halterung/Fixierung an dem Aerosolgenerator 2 und/oder der Mischkammer 3 ausgebildet ist. Besonders vorteilhaft ist das in Figur 1A und IB gezeigte Ausführungsbeispiel auch deshalb, weil das Einatemventil 20 zur Abdichtung der Verbindungsstelle zwischen Aerosolgenerator 2 und Mischkammer 3 eingesetzt wird. Dazu ist der Randabschnitt 25 des Einatemventils 20 an die stirnseitigen Querschnitte des Aerosolgenerators 2 und der Mischkammer 3 angepasst. Die Figuren 3A und 3B zeigen, dass die Anpassung desBracket / fixation on the aerosol generator 2 and / or the mixing chamber 3 is formed. The exemplary embodiment shown in FIGS. 1A and IB is also particularly advantageous because the inhalation valve 20 is used to seal the connection point between the aerosol generator 2 and the mixing chamber 3. For this purpose, the edge section 25 of the inhalation valve 20 is adapted to the end cross sections of the aerosol generator 2 and the mixing chamber 3. Figures 3A and 3B show that the adjustment of the
Randabschnitts 25 sehr weit gehen kann, wobei aber stets leicht ein Übergang zu dem erfindungsgemäßen trichterartig zulaufenden Ventilelement 21 mit Ventilöffnung 22 geschaffen werden kann. Jedoch wird durch diese Art der Anpassung erreicht, dass das für Abdichtungszwecke grundsätzlich geeignete Material des Einatemventils 20 auch für die Abdichtung des Übergangs zwischen Aerosolgenerator 2 und Mischkammer 3 herangezogen wird. Daraus ergibt sich ferner, dass das erfindungsgemäße Einatemventil 20 vorzugsweise einstückig ausgebildet ist. Edge section 25 can go very far, but a transition to the funnel-like valve element 21 according to the invention with valve opening 22 can always be easily created. However, this type of adaptation ensures that the material of the inhalation valve 20 which is fundamentally suitable for sealing purposes is also used for sealing the transition between the aerosol generator 2 and the mixing chamber 3. It also follows that the inhalation valve 20 according to the invention is preferably formed in one piece.

Claims

Patentansprüche claims
halationstherapievorrichtung mithalation therapy device with
a. einem Aerosolmembrangenerator (2), i. mit einem Flüssigkeitsvorratsbehälter (4), in den eine therapeutisch einsetzbare Flüssigkeit (5) einfüllbar ist, ii. mit einer Membran (6), die auf einer Seite' mit dem Flüssigkeitsbehälter (4) derart in Verbindung steht, dass eine in den FlüssigkeitsVorratsbehälter eingefüllte Flüssigkeit (5) in Berührung mit einer Seite der Membran (6) gelangt, und iii. mit einem Schwingungsgenerator (7), durch den die Membran (6) in Schwingungen versetzbar ist, so dass eine in den Flüssigkeitsvorratsbehälter eingefülltea. an aerosol membrane generator (2), i. with a liquid reservoir (4) into which a therapeutically usable liquid (5) can be filled, ii. with a membrane (6) which is connected on one side 'to the liquid container (4) in such a way that a liquid (5) filled into the liquid storage container comes into contact with one side of the membrane (6), and iii. with a vibration generator (7), by means of which the membrane (6) can be set in vibration, so that one is filled into the liquid storage container
Flüssigkeit (5) durch Öffnungen der Membran (β) hindurch auf der anderen Seite der Membran zu einem Aerosol zerstäubt wird,Liquid (5) is atomized through openings in the membrane (β) on the other side of the membrane to form an aerosol,
b. einer Mischkammer (3), in die hinein derb. a mixing chamber (3) into which the
Aerosolmembrangenerator (2) das Aerosol erzeugt, undAerosol membrane generator (2) which produces aerosol, and
c. einem Einatemventil (20, 21), i. das in Einatemphasen den Zustrom vonc. an inhalation valve (20, 21), i. that in inhalation phases the influx of
Umgebungsluft in die Mischkammer (3) zulässt und in Ausatemphasen das Austreten des Aerosols aus der Mischkammer (3) verhindert, ii. das einen Wandabschnitt der Mischkammer (3) bildet, iii. das einen trichterartig zulaufenden Bereich (23) aufweist, dessen zulaufendes Ende eine Ventilöffnung (22) umfasst und sich zum Aerosolmembrangenerator (2) erstreckt, so dass ein die Ventilöffnung (22) umschließender Rand (24) in der Ruhelage des Einatemventils (20, 21) auf einer Oberfläche des Aerosolmembrangenerators (2) die Membran (3) umschließend angeordnet ist.Allows ambient air into the mixing chamber (3) and prevents the aerosol from escaping from the mixing chamber (3) in exhalation phases, ii. that forms a wall section of the mixing chamber (3), iii. which has a funnel-like region (23), the end of which comprises a valve opening (22) and extends to the aerosol membrane generator (2), so that an edge (24) surrounding the valve opening (22) in the rest position of the inhalation valve (20, 21 ) on a surface of the aerosol membrane generator (2) surrounding the membrane (3).
2. Inhalationstherapievorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass der trichterartige Bereich (23) des Einatemventils (20) abgerundet, konisch-eben, stufig oder meanderförmig ausgestaltet ist.2. Inhalation therapy device according to claim 1, characterized in that the funnel-like area (23) of the inhalation valve (20) is rounded, conical-flat, step-like or meandering.
3. Inhalationstherapievorrichtung nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass der Rand (24) der Ventilöffnung (21) umlaufend eine Verdickung oder einen Wulst aufweist.3. Inhalation therapy device according to claim 1 or 2, characterized in that the edge (24) of the valve opening (21) has a thickening or a bead all around.
4. Inhalationstherapievorrichtung nach Anspruch 1, 2 oder 3, dadurch gekennzeichnet, dass das Einatemventil (20) ein Ventilelement (21) und einen Randabschnitt (25) aufweist.4. Inhalation therapy device according to claim 1, 2 or 3, characterized in that the inhalation valve (20) has a valve element (21) and an edge portion (25).
5. Inhalationstherapievorrichtung nach Anspruch 4, dadurch gekennzeichnet, dass Randbereich (25) für die Halterung des Einatemventils (20) , insbesondere für das Einklemmen zwischen Aerosolgenerator (2) und Mischkammer (3) ausgestaltet ist.5. Inhalation therapy device according to claim 4, characterized in that the edge region (25) is designed for holding the inhalation valve (20), in particular for the clamping between the aerosol generator (2) and the mixing chamber (3).
6. Inhalationstherapievόrrichtung nach einem der vorangegangenen Ansprüche, dadurch gekennzeichnet, dass das Einatemventil (20) aus einem elastischen Material hergestellt ist. 6. inhalation therapy device according to one of the preceding claims, characterized in that the inhalation valve (20) consists of an elastic Material is made.
PCT/EP2003/012404 2002-11-07 2003-11-06 Inhalation therapy device WO2004041336A1 (en)

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DE10251865A DE10251865B3 (en) 2002-11-07 2002-11-07 Inhalation unit comprises an aerosol membrane generator with a vessel for a therapeutic liquid, a membrane and an oscillation generator
DE10251865.3 2002-11-07

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