CA2389927A1 - Device for inhaling medicaments using supported pressure respiration - Google Patents

Device for inhaling medicaments using supported pressure respiration Download PDF

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Publication number
CA2389927A1
CA2389927A1 CA002389927A CA2389927A CA2389927A1 CA 2389927 A1 CA2389927 A1 CA 2389927A1 CA 002389927 A CA002389927 A CA 002389927A CA 2389927 A CA2389927 A CA 2389927A CA 2389927 A1 CA2389927 A1 CA 2389927A1
Authority
CA
Canada
Prior art keywords
reservoir
gas
distributor
mouthpiece
wall
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
Application number
CA002389927A
Other languages
French (fr)
Inventor
Michael Hermanussen
Karl-Heinz Rolli
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of CA2389927A1 publication Critical patent/CA2389927A1/en
Abandoned legal-status Critical Current

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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
    • A61M15/0086Inhalation chambers
    • 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
    • A61M15/0086Inhalation chambers
    • A61M15/0088Inhalation chambers with variable volume
    • 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
    • A61M16/0057Pumps therefor
    • A61M16/0078Breathing bags
    • 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
    • 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
    • A61M16/209Relief valves

Abstract

The invention relates to a small, light device (1) for inhaling medicaments using supported pressure respiration, comprising a mouthpiece (2), a reservoir (5; 12), which has a variable volume for receiving respiratory gas and which can be connected to the mouthpiece (2) and into the flow either directly or using a distributor (3), an adjustable, gas-tight closure (8) between the mouthpiece (2) and the reservoir (5; 12) and at least one connecting element (10; 17) for the medicament supply to the reservoir, (5; 12), said medicament being supplied either directly or indirectly, using a distributor (3). The reservoir (5; 12) has a wall which adjusts to its change in volume. Said wall can be expanded against a restoring force by the pressurised influx of respiratory gas, in such a way that the supported pressure respiration takes place using the effect of the restoring force during inhalation of the respiratory gas which contains the medicament.

Description

'~ CA 02389927 2002-05-03 PGT/EP00I11512 (1N0 01/87910 A1) BN 6C13 PCT-CA
Device for inhaling pharmaceutical drugs with auxiliary positive-pressur~ respiration Tho invention relates to a device for inhaling pharmaceutical drugs by means of auxiliary positive-pressure respiration.
During normal spontaneous human breathing, inhalation occurs in that the respiratory muscles actively expand the thorax, thereby creating a pressure gradient, with the result that air is drawn irt, i.e. flows into the lungs in accordance with the pressure gradient. F~chaling occurs passively in that a pressure rise takes place in the lung as the thorax is restored elastically to its default position, wifih the result that the consumed air is expelled from the thorax and the lungs. The mean pressure level by means of which inhalation and exhalation occur alternately corresponds to the atmospheric pressure.
Under condftlons of illness or disease, e.g. in the case of asthma, small and medium-sized respiratory tracts (bronchial tubes) in the lungs can become constricted. The flow resistance in them increases, particularly during exhalation, with the result that the patient is forced to work actively by means of his muscles even during exhalation. As a consequence an additional pressure increase occurs in the thorax which can r~sult in a complete collapse of the constricted respiratory tracts and it being impossible to expel air from the relevant sections of the lungs (1e. air is trapped). Such situations oft~n occur in the farm of attacks and can be acutely life-threatening for the patient (acute asthma attack), Devices with which the patient can inhale pharmaeeutioal drugs himself are known in the art. These pharmaceutical drugs are g~neral introduced into the r~spiretory tracts via the mouth as an aerosol or powder inhalant by means of a nebuliser or atomiser. An advantageous embodiment is also represented by retarding chambers, such as spacers, in which a particular volume of air is enrichQd with aerosol or powder inhalant before being inhaled and then made available for inhalation. This improves the effectiveness of the inhaled pharmaceutical drugs.
The disadvantage of suoh simple, easily portable, non-electrically operated inhalation systems that can be used by the patient himself in an emergency is that they can only be operated at atmospheric pressure. Lung sections which cannot ,, take part in spontaneous breathing because of the above-described collapse of small respiratory tracts therefore remain inaccessible at atmospheric pressure even during emergency treatment with inhaled pharmaceutical drugs.
Respiration under positive pressure is known in the art. Such mefihods are applied in particular in breathing apparatus used in a non-breathable atmosphere and by divers. The disadvantage of such methods is that they are not designed for patients suffering from acute breathing difficulties and are also complex, requiring valves, tubing and also, if appropriate, as with breathing apparatus with a closed breathing circuit and diving equipment, a carbon dioxide absorber to process the exhaled air which is rich in carbon dioxide. The standard positive-pressure respiration system for treating patients with severe breathing difficulties is generally in the form of complox, fixed respirators in hospital areas designed for this purpose and proceeds either automatically (mechanical respiration without action by the patient) or in assisted mode (with action by the patient), or -if the patient is breathing spontaneously - also via CPAP (continuous positive airway pressure). Respiration can be carried out with positive pressure either continuously or intermittently. Simple, non-electrically-operated manual devices for this purpose are not known in the art.
It is the object of this invention to create a very simple, small, portable, easily operated, integrated, self contained device which is independent of electrical power and is suitable in particular for asthmatics and patients with other obstructive lung diseases for temporarily improving the inhalation of pharmaceutical drugs which efficiently combines the therapeutic effect of inhaled pharmaceutical drugs, the advantages of a retarding chamber and the physical effect of positive-pressure respiration for a brief period, i.e. for the limited period of acute breathing difficulties.
The object is resolved by a device with the characteristic features of claim 1.
In accordance with the invention a very simple, small, portable, easily operated, integrated and self contained device is proposed which can comfortably be stored in a (hand)bag. The devices consists of a closed system into which the patient can exhale without a breathing air circuit being created. By contrast with the complex respirators which operate with a closed breathing circuit and at a pressure greater b than atmospheric pressure, there is no provision here for the necessary valves and tubing. Similarly, no processing of the exhaled gas, e.g. in a carbon dioxide absorber, takes place, meaning that a device in accordance with the invention is limit~d to a few minutes of use, i.e. to th~ duration of the acut~ breathing difficulties, because of the accumulation of carbon dioxide.
The device comprises a mouthpiece which can be fully encompassed by the lips;
a reservoir which has a variable volume to accommodate inhalant gas, can be connected to the mouthpiece in the direction of flow either directly or via a distributor and provides the characteristic features of a retarding chamber;
an adjustable airtight closure between the mouthpiece and the reservoir; and at least one connection for the pharmaceutical drug feed in the farm of an aerosol or powder inhalant to the reservoir, with the pharmaceutical drug feed being either direct or indirect via a distributor. An essential feature is that the reservoir has a variable wall to enable it to change its volume, where said wall can be expanded under the pressure of inflowing inhalant gas against a restoring foroe such that, a3 8 result of the action of the restoring force, auxiliary positive-pressure respiration occurs when the inhalant gas containing the pharmaceutical drug is inhaled.
Advantageous embodiments of the invention are described in the dependent claims.
The variable wall of the reservoir can be embodied in various ways so that it is at least partially movable, for example being formed of a combination of rigid and movable sections. In accordance with a preferred embodiment the variable wall has at least one elastic wall and an elastic balloon in particular forms the reservoir.
A further variant provides for the reservoir to have at least one rigid wall section on which a distributor andlor at least one connection for the mouthpiece, the inhalant gas filler connection or the pharmaceutical drug feed are provided.
A preferred embodiment provides for a gas reservoir with a compression-proof wall containing comer~ssed inhalant gas to be connected to the reservoir directly or indirectly via a distributor and for a reclosable valve to be configured between the gas reservoir and th~ reservoir. In this device the gas reservoir is frlled when in transport mode, and the reservoir, which is preferably in the form of a balloon with a floppy elastic wall, is empty. In accordane~ with the invention the pharmaceutical drugs are inhaled by first opening the filled gas reservoir with a compression-proof wall by means of a valve, allowing oxygen or oxygen-rich air to flow into the elastic-walled reservoir. As soon as the elastic-walled reservoir is sufficiently full, thQ valve between the gas reservoir with a compression-proof wall and the elastic-walled reservoir can b~ closed again, for example by the uscr. This means that, as GG-of r. ~~rr~ ...~ --in a balloon, the pressure in the elastic-walled reservoir is slightly higher than atmospheric pressure, at between greater than 0 and approx. 30 cm water column.
This is caused by the elastic wall tension of the reservoir. Pharmaceutical drugs which act on the respiratory tracts can now be introduced into the elastic-walled reservoir, which thus takes on the function of a retarding chamber, from at least one commercially available bottle far the spray inhalation of pharmaceutical drugs.
The device is now ready for use and can be used by the patient.
The patient encompasses the mouthpiece firmly with his lips, then either fits a nose clip or actively blocks his palate to prevent the physiological route for air through the nose, and then opens the airtight closure between the mouthpiece and the elastic-walled reservoir by pressing with his finger or by means of s device which automatically opens the closure when the patient first inhales. The increased pressure in the elastic-walled reservoir is also transferred to the patient's lungs via the respiratory tracts, thereby allowing oxygen and pharmaceutical drugs to enter the patient's lungs until the pressure gradient between the elastic-walled reservoir and the lungs has equalised. In this process oxygen and pharmaceutical drugs are also forced into those sections of the lungs which were inaccessible as a result of constricted and previously collapsed respiratory tracts at atmospheric pressure.
The lungs are therefore pre-inflated for the p~riod that the dovice in accordance with the invention is in use, and the pressure in them corresponds no longer to atmospheric pressure 'but to the pressure set by the elasticity of the reservoir wall or by a sprung device in the case of reservoir wall elements which can slide over each other. Continued inhalation and exhalation occurs, as in the case of the previous spontaneous breathing at atmospheric pressure, by alternate active muscular expansion and elastic contraction of the fihorax_ This counteracts the collapse of the small respiratory tracts which occurs as a result of disease and also enables those lung sections to be treated by means of inhalation which were inaccessible, l.c. were not reached by spontaneous breathing, at atmospheric pressure.
Because the patient draws inhalant gas and pharmaceutical drugs from a closed system into which he exhales again without processing of the exhaled gas, oxygen is consumed, and the carbon dioxide level is enriched_ Because of the latter feature in particular, the patient must cease inhalation with the device in accordance with the invention after a short period within which the state of acute breathing difficulty should have improved.

~) _ s If pharmaceutical drugs need to be inhaled again by means of auxiliary positive-pressure respiration, the consumed inhalant gas is discharged from the reservoir via the closure and the mouthpiece, and the gas reservoir is opened again via the valve. The process as described above is then repeated.
The volume and elasticity or restoration properties of the reservoir can be individually adjusted by s~lecting en appropriate balloon or restoration device such as a spring.
If it is decided to dispense with multiple use of the device in accordance with the invention and instead to use it only for single-use emergency treatment, the gas reservoir with a compression-proof wall in a further advantageous embodiment of the invention with improved handling only needs to contain oxygen for a single use. This enables the device to be designed such that it is even smaller and lighter, and it is also possible to dispense with a reclosable valve between the g8s reservoir with a compression-proof wall and the reservoir with a variable wall. In this case, however, a new gas reservoir must be fitted before each new use.
The central functional element of the invention is the reservoir with a variable or at least partially elastic wall which is both responsible for tho respiration pressure and also, like a retarding chamber, delivers a certain volume of inhalant gas which is enriched with aerosol or powder inhalant before being inhaled. Various practical embodiments of the invention are possible; in particular, the various elements of the device in accordance with the invention can either be connected separately to a central distributor or, like a set of bagpipes, the mouthpiece and the connections for the gas reservoir with a compression-proof wall and the bottles far the spray inhalation of pharmaceutical drugs can open directly into the elastic-walled reservoir.
Embodiments of the device in accordance with the description are described below with reference to the drawings, in which:
Fig. 1 is a schematic front view of a first embodiment of a device for inhaling pharmaeetrtical drugs in accordance with the invention;
Fig. 2 is a side view of the inhalation device;
Fig. 3 is a view of the inhalation device; and p'ig. 4 is a schematic side view of a second embodiment of a device in accordance with the invention.
A first embodiment of a device 1 for improved inhalation of pharmaceutical drugs by means of auxiliary positive-pressure respiration comprises a mouthpiece 2 and a distributor 3 to which the mouthpiece 2 is connected. An adjustable, airtight closure 8 is configured between the mouthpiece 2 and the distributor 3. A gas reservoir 4 with a compression-proof wall and a reservoir 5 with an elastic wall and variable volume, for example a balloon, are mounted on separate Connections 6 and 7, respectively, of the distributor 3. The reservoir 5 can also take the form of a conc~rtlna with an internal tension spring (not shown), which acts on the concertina to reduce its volume. Compressed inhalant gas can flow out of the gas reservoir 4 by means of a valve 11 on the connection 7 and then through the distributor 3 into the reservoir 5, thereby increasing the volume of the latter against the elastic force of the wall of the reservoir 5.
A commercially available bottle 9 for the spray inhalation of pharmaceutical drugs is mounted on a s~parate connection 10 of the distributor ~. The pharmaceutical drug can be introduced in the form of an aerosol or powder inhalant from the bottle 9, e.g. at the press of a finger, via the distributor 3 into the reservoir 5, which acts like a retarding chamber.
The mouthpiece 2 and the distributor 3 are preferably made of easily cleaned plastic. The gas reservoir 4 with a compression-proof wall can be a standard pressurised-gas bottle which preferably contains at least one or a plurality of inhalant gas doses for the reservoir 5 or the balloon.
If, in a variant of the device according to the invention, a distributor 3 is dispensed with, the mouthpiece 2 is connected to the adjustable, airtight closure 8, and the gas reservoir 4 with a compression-proof wall and at least one commercially available bottle 9 far the spray inhalation of pharmaceutical drugs is connected directly to the elastio-walled reservoir 5 (not shown) by means of separate connections.
The operation of the device 1 for the improved inhalation of pharmacEUtical drugs by means of auxiliary positive-pressure respiration without a distributor corresponds in principle to that of the variant with a distributor.

~ 7 ,>
in a device {not shown) which has been mod~ed by comparison with the above-described device 1, the distributor 3 contains only three connections for the mouthpiece 3, the botkle 9 and the reservoir 5, with the fourth connection 7 having been omitted. The inhalant gas used to support inhalation by means of positive pressure is introduced into the reservoir 5 by connecting the latter to and filling it from an inhalant gas source, e.g. an inhalant gas bottle or an inhalant gas connection in a laboratory. The rEServoir 5 is then connected to the connection 6 of the distributor 3, the pharmaceutical drug is introduced into the reservoir 5 from the bottle 9, and the inhalant gas containing the pharmaceutical drug can be inhaled via the mouthpiece 2 after the closure 8 has been opened. If a balloon is used as the reservoir 5, the elastic balloon connection is attached to the inhalant gas source and, after Flling, is temporarily closed by squeezing the neck as with a standard play balloon, until the balloon connection has been attached to the connection 6 of the distributor 3.
A further embodiment of the device shown in Fig. 4 contains a reservoir 12 with a wall enclosing the variable volume made of two solid, telescvpable - e_g.
cylindrical - wall elements 13 and 14 which are pre-tensioned to reduce the volume of the reservoir 12 by means of, for example, a tension spring 15 mounted inside the reservoir 12. The mouthpiece 2 is directly connected to the wall element 14 of the reservoir 12 via a connectfon pipe 16 which contains a closure 8 that Is operated manually or automatically when the patient inhales far the first time.
Furthermore, the wall element 14 contains a connection 17 for the bottle 9 containing a pharmaceutical drug and a filler connection 18 for inhalant gas on which a locking valve 19 is mounted.
In this device the reservoir 12 therefore comprises a wall made of rigid wall elements, though said wall elements form en e(a~stic wall with reference to the variable volume because of the elastic restoring force of the tension spring 15.
To prepare the device for inhalation, the inhalant gas filler connection 18 is connected to an inhalant gas source, and the reservoir 12 is filled with pressurised inhalant gas, during which the two wall elements 13 and 14 move relative to each other against the force of the tension spring to increase the volume_ knee the required volume of inhalant gas has flowed into the reservoir 12, the locking valve 19 is closed, and the reservoir 12 is removed from the inhalant gas source_ After the pharmaceutical drug has been introduced into the reservoir 12 from the bottle 9, the device is ready for inhalation.

f. . . g The mutual movement of the two wall elements 13 and 14 to increase the volume is limited by means flf, for example, a stop. A pressure relief valve can be provided in the wall of the reservoir 12 to avoid exceeding the maximum permissible inhalant gas pressure when filling the reservoir 12 with inhalant gas.
To provide a larger inhalant gas volume of approx. 3-4 litres for this device, an unfoldable, airtight, elastically extendable or non-extendable bag or similar can be attached tv the slidable wall element 13, When not in use, this bag remains folded away and therefore small; when the device is in use, it can be unfolded and filled with inhalant gas. If the volume change as a result of the movable wall element is insufficient for positive-pressure support for inhalation, the elastic, balloon-like bag can provide the additional assistance.

Claims (11)

Claims
1. Device (1) for inhaling pharmaceutical drugs by means of auxiliary positive-pressure respiration, containing a mouthpiece (2), a reservoir (5; 12) which has a variable volume to accommodate inhalant gas and can be connected to the mouthpiece (2) in the flow path either directly or via a distributor (3), an adjustable, airtight closure (8) between the mouthpiece (2) and the reservoir (5;
12), and at least one connection (10; 17) to feed the pharmaceutical drugs to the reservoir (5; 12), with said pharmaceutical drug feed being either direct or indirect via a distributor (3), in which said reservoir (5; 12) has a variable wall to change its volume which can be extended by inflowing pressurised inhalant gas acting against a restoring force, with the result that there is positive-pressure assistance when the inhalant gas containing the pharmaceutical drug is inhaled because of the action of the restoring force.
2. Device as claimed in claim 1, characterised therein that the variable wall is at least partially movable.
3. Device as claimed in claim 1 or 2, characterised therein that the variable wall is, at least in part, an elastic wall and in particular is a balloon forming the reservoir (5).
4. Device as claimed in claim 1 or 2, characterised therein that the reservoir (12) comprises at least one rigid wall section (14), to which a distributor and/or at least one connection (16) for the mouthpiece (2), the inhalant gas filler connection (18) or the pharmaceutical drug feed (17) are attached.
5. Device as claimed in claim 4, characterised therein that the reservoir (12) comprises at least two wall elements (13, 14) which can move over each other, can be displaced relative to each other to increase the volume and are elastically pre-tensioned against a sliding motion to increase the volume by means of a sprung device (15).
6. Device as claimed in any one of claims 1 to 5, characterised therein that the reservoir (5; 12) has a lockable inhalant gas filler connection.
7. Device as claimed in claim 6, characterised therein that the inhalant gas filler connection (7) can be locked by means of a closure (11).
8. Device as claimed in claim 6, characterised therein that the reservoir (5) has an elastic wall at its filler opening which can be locked by squeezing it together.
9. Device as claimed in any one of claims 1 to 8, characterised therein that a gas reservoir (4) with a compression-proof wall containing pressurised inhalant gas is connected to the reservoir (5) either directly or indirectly via a distributor (3), and that a reclosable valve (11) is configured between the gas reservoir (4) and the reservoir (5).
10. Device as claimed in any one of claims 1 to 9, characterised therein that the distributor is a three-way distributor to connect the mouthpiece (2), the reservoir (5) and the pharmaceutical drug feed (10) or a four-way distributor (3) to connect the mouthpiece (2), the reservoir (5), the pharmaceutical drug feed (10) and the gas reservoir (4).
11. Device as claimed in any one of claims 1 to 10, characterised therein that the inhalant gas has an oxygen level of between 21%
and 100%.
CA002389927A 1999-11-20 2000-11-20 Device for inhaling medicaments using supported pressure respiration Abandoned CA2389927A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19955902 1999-11-20
DE19955902.3 1999-11-20
PCT/EP2000/011512 WO2001037910A1 (en) 1999-11-20 2000-11-20 Device for inhaling medicaments using supported pressure respiration

Publications (1)

Publication Number Publication Date
CA2389927A1 true CA2389927A1 (en) 2001-05-31

Family

ID=7929755

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002389927A Abandoned CA2389927A1 (en) 1999-11-20 2000-11-20 Device for inhaling medicaments using supported pressure respiration

Country Status (6)

Country Link
US (1) US6701915B1 (en)
EP (1) EP1409052A1 (en)
JP (1) JP2003514630A (en)
AU (1) AU1703401A (en)
CA (1) CA2389927A1 (en)
WO (1) WO2001037910A1 (en)

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WO2017181228A1 (en) * 2016-04-18 2017-10-26 Telethon Kids Institute Spacer device for an inhaler
KR102458332B1 (en) * 2020-09-25 2022-10-24 인제대학교 산학협력단 Inhaler for tracheostomy patients

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Also Published As

Publication number Publication date
WO2001037910A1 (en) 2001-05-31
US6701915B1 (en) 2004-03-09
EP1409052A1 (en) 2004-04-21
JP2003514630A (en) 2003-04-22
AU1703401A (en) 2001-06-04

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Legal Events

Date Code Title Description
EEER Examination request
FZDE Discontinued