EP2823798A1 - Vorrichtung zur Zusammenführung von Substanzen, insbesondere zur Rekonstitution von Injektionslösungen - Google Patents
Vorrichtung zur Zusammenführung von Substanzen, insbesondere zur Rekonstitution von Injektionslösungen Download PDFInfo
- Publication number
- EP2823798A1 EP2823798A1 EP13176031.6A EP13176031A EP2823798A1 EP 2823798 A1 EP2823798 A1 EP 2823798A1 EP 13176031 A EP13176031 A EP 13176031A EP 2823798 A1 EP2823798 A1 EP 2823798A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- housing
- bag
- pressure plate
- syringe
- injection
- 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.)
- Withdrawn
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D83/00—Containers or packages with special means for dispensing contents
- B65D83/0055—Containers or packages provided with a flexible bag or a deformable membrane or diaphragm for expelling the contents
- B65D83/0077—Containers or packages provided with a flexible bag or a deformable membrane or diaphragm for expelling the contents moves by a spring-like mechanism
Definitions
- the invention relates to a device for combining substances, in particular for the reconstitution of injection solutions.
- Such devices are needed, for example, for injection solutions whose ingredients are not storable in a mixed form, so that, for example, a lyophilized drug is mixed with a solvent before administration and then drawn into a syringe.
- a disadvantage of the known systems is that in some cases up to 20 working steps have to be carried out until the injection solution is drawn up in the syringe and ready for injection. It also requires a degree of care and skill, with frequent misuse. Finally, in many systems, different components must be stored separately, which increases the overall cost.
- the handling should be as simple and safe as possible.
- a device having the features in claim 1.
- the arranged in a housing, flexible bag serves to receive a liquid, which is usually a solvent.
- a dispensing device is arranged, which is usually an injection syringe.
- Other dispensers such as e.g. Dropper, Sprühgefässe or the like would be conceivable without further ado.
- a transfer channel for the direct or indirect transfer of the liquid leads from the bag into the delivery device.
- the hydraulic pressure for the transfer of the liquid is applied by at least one pressable against the bag pressure plate for squeezing the bag. These at least one pressure plate is housed in the mentioned housing, so that the device forms a compact unit, which can be easily stored and transported.
- the device is equipped with two printing plates, between which the bag is arranged.
- the bag can be squeezed out so that it always remains approximately in the same plane, each of the two pressure plates must perform a smaller movement, as with a single pressure plate.
- each pressure plate has two articulated sections which are movable from an angled rest position to an extended squish position.
- the pressure plates do not act plane-parallel to the flexible bag, but there is squeezing out from the outer edge towards the center of the bag.
- the two sections can be connected to each other, for example via a film hinge.
- the printing plates may be made of plastic material and be produced for example by injection molding. It is also possible that the printing plates are structured on the side facing away from the bag and functional elements such. Reinforcing ribs, cams or the like.
- the housing may have a connecting piece for connecting a container containing a second substance, wherein the connecting piece communicates via a valve device with the transfer channel and / or with the flexible bag.
- This connection piece can be provided with coupling means for holding a container mouth as well as with a hollow needle for penetrating the closure element on the container. In this way, a container with an arbitrary substance can be connected to the device.
- an additional container preferably also a flexible bag, is arranged, which communicates via a valve device with the transfer channel.
- a valve device preferably also a liquid.
- valve device for shutting off the fluid connection between the flexible bag and the dispensing device is arranged in the transfer channel, wherein the valve device can be brought into the open position by a lifting movement.
- An activatable by means of stroke movement valve device can be controlled very easily.
- other valve functions would be conceivable such. a flap valve or a tap.
- a particularly advantageous function can be achieved if a mechanical energy store, in particular a spring mechanism is arranged as a drive in the housing, with which the pressure plate can be pressed against the bag.
- a mechanical energy store in particular a spring mechanism is arranged as a drive in the housing, with which the pressure plate can be pressed against the bag.
- Such an energy storage causes the pressure plate is almost always applied position-independent with the same force, wherein the transfer of the liquid always takes place in the same time.
- a spring mechanism is particularly advantageous for this purpose, because it can be applied safely and lossless sufficient forces.
- Alternative energy storage such as e.g. Compressed air storage or batteries for driving a micromotor would be conceivable.
- a magnetic actuation of the printing plate would be possible in principle.
- the lifting movement on the valve device and the pressure plate are activated with the same drive.
- these movements can be performed sequentially.
- the lifting movement or another movement for valve actuation is performed manually and that with the help of the drive, only the pressure plate is activated.
- a spring mechanism with at least one coil spring is arranged in the housing.
- Such a spring mechanism is simple and inexpensive to produce and depending on the design of the coil spring is sufficient energy for various functions available.
- Spring mechanisms of this type are also well known and common in other fields of technology.
- the drive axle of the spring mechanism can be connected to a cam disk for forming the rotational movement into at least one linear force component.
- By means of the cam can be converted into a linear force in a relatively simple manner, the torque of the spring mechanism.
- the at least one pressure plate can be mounted linearly displaceable together with the bag in the housing and in particular relative to the cam. In this way, there is a lifting movement with which a valve device can be activated. In the case of using a cam, this can cooperate with engagement members on the pressure plate such that it initially performs a linear movement and is then pressed while maintaining the reached end position against the bag. This results in a composite movement, with the help of which the valve is first actuated, in order subsequently to effect the transfer of the liquid.
- the squeezing of the bag could also be done with other mechanical means, for example via a linkage or over against the pressure plate pressable rollers or pins or directly via a spring which presses directly against the pressure plate.
- the housing may have a lid, wherein the drive can be activated by opening the lid.
- the drive can be activated by opening the lid.
- the lid With the help of the lid, in particular the removable from the housing dispenser is protected and held in position.
- Activation of the drive by means of the lid movement has the advantage that the transfer of the liquid from the flexible bag takes place automatically, without the need for activating further actuating means.
- Activation of the drive would of course also be conceivable via a pushbutton or the like.
- a particularly advantageous transfer of the liquid into an injection syringe with a filling opening mounted in the housing can take place in that the injection syringe has a needle holder which communicates with the transfer channel, wherein the filling opening can be closed during removal of the injection syringe from a syringe holder.
- the piston is retracted.
- the solution for injection is taken up via the filling opening by actuation of the piston and when removing it from the syringe holder, the filling opening closes automatically so that the solution for injection can only be dispensed via the needle.
- Such mechanisms are already known per se and, for example, in the EP 2 559 414 described.
- hypodermic syringe or another type of dispensing device is stored in the housing, which already contains a second substance. In this way, the reconstitution of the liquid to be dispensed would take place directly in the dispenser itself.
- the flexible bag is advantageously arranged between two printing plates, which can be activated either via a common drive or individually assigned to the printing plates drives.
- each pressure plate can be associated with a spring mechanism with its own cam.
- These two cams can also have such differently shaped curve sections that the printing plates can be pressed in an asymmetrical movement against the bag. This will ensure that the bag is squeezed in such a way that no pockets of fluid remain.
- a designated 1 device essentially of a housing 2, with a lid 24. This is mounted on a cover joint 36 pivotally mounted on the housing.
- a syringe holder 29 is formed, which receives a syringe designated 5 play.
- Parallel to the syringe holder two congruent pressure plates are arranged, of which only the one pressure plate 7 is visible here.
- a spring mechanism 16 is fixedly mounted in the housing, whose function will be described in more detail below.
- Below the two pressure plates protrudes a connection piece 9 from the housing 2, in which a container 10 can be inserted.
- the syringe 5 has a piston 25, which, however, in the starting position according to FIG. 2 retracted.
- the needle of the injection syringe which is not visible here, rests in a quiver 37, which runs approximately parallel to the connecting piece 9.
- FIGS. 3 to 6 show further structural details, according to the FIGS. 3 and 4 the device is rotated such that the cover 24 is below and the connecting piece 9 above.
- FIG. 4 is visible between the two pressure plates 7, 7 'a flexible bag 3, in which a liquid, such as a solvent is filled.
- the two printing plates are present in a starting position the squeezing out of the bag 3.
- each of the two pressure plates consists of two separate sections 8a, 8b, which are hinged together along a film hinge 38.
- Each pressure plate 7 and 7 ' is assigned its own spring mechanism 16 and 16', wherein each spring mechanism has a spiral spring 17.
- FIG. 6 is still a piercing mandrel 34 visible in the center of the connecting piece, with the aid of a closure element of the container 10 can be pierced.
- FIGS. 7 and 8 show the device according to the FIGS. 3 and 4 However, after the squeezing of the bag 3. This is now flat between the two pressure plates 7 and 7 ', which are moved together plane-parallel under the action of the two spring mechanisms 16 and 16'. The originally slightly angled plate sections 8a, 8b, are now stretched flat.
- the coil spring 17 of a spring mechanism 16 surrounds in several turns a drive axle 18 which is formed in the present case as a hollow hub and which is mounted in the side wall of the housing.
- the free end 39 of the coil spring is laterally supported on a spring stop 40.
- the spring mechanism can be mounted from the outside, so that the coil spring exerts a torque on the drive axle 18.
- a locking gear 32 ensures that a cam 19 is rotatable only in the drive direction, while it is prevented from rotating when mounting the spring mechanism by a stop 30.
- the cam 19 further has a press wedge segment 21, which is curved in the circumferential direction, as well as a lifting cam 20 which bears against a stroke stop 22 of the pressure plate 7.
- the printing plate also has a support shoulder 33 with a corresponding to the press wedge segment 21 curvature.
- a similar spring mechanism is arranged, which is also associated with a press wedge segment 21 '.
- the latter has a somewhat flatter wedge inclination, so that the two pressure plates are acted upon by force unbalanced.
- the two pressure plates with the flexible bag arranged therebetween are linearly displaceable relative to the two spring mechanisms, wherein they can cover a stroke of, for example, about 2 to 3 mm.
- FIG. 11 shows the situation after activation of the spring mechanism and thus after the squeezing of the bag.
- the lifting cam 20 ( FIG. 10 ) has the stroke stop 22 in the course of the rotational movement of the cam 19 is shifted upward, so that the entire unit consisting of the two pressure plates 7, 7 'and the flexible bag has made a lifting movement.
- the press wedge segment 21 engages under the support shoulder 33, so that reversing of the lifting movement is no longer possible.
- the locking gear 32 continues to rotate when relaxing the coil spring 17, the cam 19, wherein the press wedge segment 21 exerts a pressing force on the pressure plate 7. Exactly the same process takes place on the opposite side. Over the stroke h returned by the linear displacement of the press plates, the flexible bag is short-circuited to the transfer channel.
- FIGS. 12 to 15 The valve functions and the fluid connections are in the FIGS. 12 to 15 shown.
- the device is in the starting position, in which the bag 3 is shut off from a fluid channel 6 via the valve device 12.
- This shut-off relates both to the connection to the piercing spike 34 on the connecting piece 9 and to a filling opening 28 on a needle holder 27 of the injection syringe 5.
- the injection needle 26 is held by the needle holder 27.
- FIG. 12 is also apparent that the lid 24, a hold-down element 41 is arranged, with which the pressure plate assembly is held with the bag 3 in the starting position.
- the filling of the liquid in the flexible bag 3 is carried out in the fully assembled state via a filling channel 44. This is then inextricably closed by means of a plug 46.
- FIGS. 14 and 15 show the state after opening the lid, for reasons of clarity, no container is shown in the connection piece 9.
- the spring mechanism relaxes and this arrangement sets the stroke h ( FIG. 11 ) back.
- the valve device 12 is opened and the pressure plates press the flexible bag 3 together, wherein the contents of which are emptied into the container connected to the connecting piece 9, so that the injection liquid is processed.
- the dashed line F1 shows the flow of fluid through the discharge channel 45 out of the flexible bag through the open valve device 12 and through the connecting posts 9 into the connected container.
- the transfer channel 6 and the filling opening 28 are opened in this process, so that the liquid can also expand against the injection syringe, as far as the piston 25 and the compressed air below it allows.
- the piston 25 of the syringe can be pulled out, so that via the transfer channel 6 and the filling opening 28, the contents of the container is sucked into the syringe.
- a ventilation opening 42 ensures that no vacuum builds up in the container.
- FIGS. 16 and 17 is shown in an alternative sectional view, the connection between the bag 3 and the connecting piece 9, wherein the position 35 shows the bag connection. Since the cutting plane is not in the central axis of the connecting piece 9, this is shown only as a sub-segment.
- FIG. 18 shows the outside of a device (without lid) with inserted container 10 and drawn-out piston 25 of the syringe.
- the lateral housing walls have a bearing opening 43, in which the hollow drive axle 18 of the spring mechanism 16 is mounted. This storage is in FIG. 19 shown. Through the opening 43, the spring mechanism is mounted after assembly of the device and after closing the lid.
- a device 1 according to the invention and a sealed container 10 with a lyophilisate 11 are provided.
- the container 10 is pressed into the connecting piece 9, so that the centrally arranged piercing spike penetrates the closure of the container and the container is held firmly in the device (illustration b).
- the lid 24 can now be opened, wherein the previously described Auspressvorgang takes place.
- the injection solution can be transferred out of the container 10 by pulling the piston 25 into the injection syringe 5 in any position, but preferably in an overhead position.
- the injection syringe is then removed from the housing 2, wherein the empty syringe after application for safety reasons, in turn, can be pushed back into the housing. Subsequently, the entire unit can be disposed of.
- FIGS. 21 and 22 show by way of illustration again the positions of the pressure plate sections 8a and 8b and 8a 'and 8b' before pressing ( FIG. 21 ) and after pressing ( FIG. 22 ).
- Well visible here are the pressing tracks 23a, 23b, against which the press wedge segments of the cam press in the course of the rotational movement.
- the outsides of the press plate sections are also provided with reinforcing ribs.
- FIGS. 23 to 26 an alternative embodiment is shown, in which the Auspressmechanismus differs from that of the aforementioned embodiment.
- a common spring mechanism 50 with a locking gear 51 serves to activate both printing plates.
- a first gear segment 52 is driven via the locking gear, which meshes with a second gear segment 53.
- the axes of rotation of the two gear segments lie on both sides of the pressure plate assembly.
- the gear segments move in opposite directions and they are provided with pressing elements 55 which are pressed against the pressure plates 54 ( FIG. 25 ).
- the opposite movement of the two gear segments 52 and 53 causes a squeezing of the bag 3.
- FIG. 27 Analogous to FIG. 20 shows FIG. 27 the flow of liquid transfer in the alternative embodiment.
- the container 10 is first connected to the connecting piece 9 and then the lid 24 is opened.
- the spring mechanism is activated (c) after which the squeezing process begins.
- the complete Reconstitution of the solution for injection in the container 10 its contents can be included in the syringe.
- FIGS. 28 to 35 show a further embodiment in which no connection piece 9 is provided for connecting a container.
- an additional container 13 is arranged in the form of another bag within the housing and approximately at right angles to the first bag between the two pressure plates 7.
- the function of the pressure plate assembly after the release of the spring mechanism is the same as in the first embodiment, ie the pressure plate assembly with the first bag first returns a lifting movement, so that the lift valve 15 ( FIG. 31 and 33 ) is opened.
- the liquid passes via the transfer channel 6 and via a valve device 14 first into the additional tank 13. This is likewise a lifting valve analogous to the lifting valve 15 on the first bag.
- the treated injection liquid enters the injection syringe 5 as described above.
- the additional container 13 may be associated with a second substance, which may be either solid or liquid.
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- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Hematology (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP13176031.6A EP2823798A1 (de) | 2013-07-11 | 2013-07-11 | Vorrichtung zur Zusammenführung von Substanzen, insbesondere zur Rekonstitution von Injektionslösungen |
US14/898,784 US9801789B2 (en) | 2013-07-11 | 2014-07-07 | Device for bringing together substances, in particular for reconstitution of injection solutions |
PCT/EP2014/064441 WO2015004056A1 (de) | 2013-07-11 | 2014-07-07 | Vorrichtung zur zusammenführung von substanzen, insbesondere zur rekonstitution von injektionslösungen |
CN201480039133.8A CN105407856B (zh) | 2013-07-11 | 2014-07-07 | 用于组合物质、特别用于重组注射溶液的装置 |
EP14735596.0A EP3019139B1 (de) | 2013-07-11 | 2014-07-07 | Vorrichtung zur zusammenführung von substanzen, insbesondere zur rekonstitution von injektionslösungen |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP13176031.6A EP2823798A1 (de) | 2013-07-11 | 2013-07-11 | Vorrichtung zur Zusammenführung von Substanzen, insbesondere zur Rekonstitution von Injektionslösungen |
Publications (1)
Publication Number | Publication Date |
---|---|
EP2823798A1 true EP2823798A1 (de) | 2015-01-14 |
Family
ID=48808162
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP13176031.6A Withdrawn EP2823798A1 (de) | 2013-07-11 | 2013-07-11 | Vorrichtung zur Zusammenführung von Substanzen, insbesondere zur Rekonstitution von Injektionslösungen |
EP14735596.0A Active EP3019139B1 (de) | 2013-07-11 | 2014-07-07 | Vorrichtung zur zusammenführung von substanzen, insbesondere zur rekonstitution von injektionslösungen |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP14735596.0A Active EP3019139B1 (de) | 2013-07-11 | 2014-07-07 | Vorrichtung zur zusammenführung von substanzen, insbesondere zur rekonstitution von injektionslösungen |
Country Status (4)
Country | Link |
---|---|
US (1) | US9801789B2 (zh) |
EP (2) | EP2823798A1 (zh) |
CN (1) | CN105407856B (zh) |
WO (1) | WO2015004056A1 (zh) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106176223A (zh) * | 2016-08-30 | 2016-12-07 | 无锡兰桂医疗股份有限公司 | 一种新型自动配药装置 |
US11752070B2 (en) * | 2017-11-21 | 2023-09-12 | Sanofi | Mixing and/or reconstitution system |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2012133052A1 (ja) * | 2011-03-25 | 2012-10-04 | 株式会社湯山製作所 | 混注装置 |
WO2013003951A1 (en) | 2011-07-06 | 2013-01-10 | Duoject Medical Systems Inc. | Reconstitution device |
EP2559414A1 (de) | 2011-08-18 | 2013-02-20 | Weibel CDS AG | Adapter für eine Transfervorrichtung für ein Fluid sowie Transfervorrichtung |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6056157A (en) * | 1994-03-14 | 2000-05-02 | Gehl's Guernsey Farms, Inc. | Device for dispensing flowable material from a flexible package |
US8292848B2 (en) * | 2006-07-31 | 2012-10-23 | Bio Quiddity, Inc. | Fluid dispensing device with additive |
US8225824B2 (en) * | 2007-11-16 | 2012-07-24 | Intelligent Hospital Systems, Ltd. | Method and apparatus for automated fluid transfer operations |
EP2627604A4 (en) * | 2010-10-12 | 2016-01-13 | Tripp Middleton | LIQUID DISTRIBUTION SYSTEMS |
-
2013
- 2013-07-11 EP EP13176031.6A patent/EP2823798A1/de not_active Withdrawn
-
2014
- 2014-07-07 WO PCT/EP2014/064441 patent/WO2015004056A1/de active Application Filing
- 2014-07-07 US US14/898,784 patent/US9801789B2/en active Active
- 2014-07-07 CN CN201480039133.8A patent/CN105407856B/zh active Active
- 2014-07-07 EP EP14735596.0A patent/EP3019139B1/de active Active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2012133052A1 (ja) * | 2011-03-25 | 2012-10-04 | 株式会社湯山製作所 | 混注装置 |
WO2013003951A1 (en) | 2011-07-06 | 2013-01-10 | Duoject Medical Systems Inc. | Reconstitution device |
EP2559414A1 (de) | 2011-08-18 | 2013-02-20 | Weibel CDS AG | Adapter für eine Transfervorrichtung für ein Fluid sowie Transfervorrichtung |
Also Published As
Publication number | Publication date |
---|---|
CN105407856B (zh) | 2019-01-04 |
US20160136053A1 (en) | 2016-05-19 |
CN105407856A (zh) | 2016-03-16 |
EP3019139B1 (de) | 2017-04-19 |
US9801789B2 (en) | 2017-10-31 |
WO2015004056A1 (de) | 2015-01-15 |
EP3019139A1 (de) | 2016-05-18 |
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