EP0433422A1 - Appareil pour l'injection de quantites dosees de divers agents therapeutiques liquides - Google Patents

Appareil pour l'injection de quantites dosees de divers agents therapeutiques liquides

Info

Publication number
EP0433422A1
EP0433422A1 EP19900910109 EP90910109A EP0433422A1 EP 0433422 A1 EP0433422 A1 EP 0433422A1 EP 19900910109 EP19900910109 EP 19900910109 EP 90910109 A EP90910109 A EP 90910109A EP 0433422 A1 EP0433422 A1 EP 0433422A1
Authority
EP
European Patent Office
Prior art keywords
spraying device
container
cannula
housing
therapeutic agent
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Withdrawn
Application number
EP19900910109
Other languages
German (de)
English (en)
Inventor
Gesine Hirsch
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.)
HIRSCH Gesine
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 EP0433422A1 publication Critical patent/EP0433422A1/fr
Withdrawn legal-status Critical Current

Links

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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2448Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/19Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3128Incorporating one-way valves, e.g. pressure-relief or non-return 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/20Blood composition characteristics
    • A61M2230/201Glucose concentration

Definitions

  • the invention relates to a spray device for injecting metered amounts of various liquid therapeutic agents, in particular insulins.
  • Such a sprayer for example, the insulin injection device Hoechst that 'the market under the name "OptiPen ⁇ ” link.
  • Spare sheet pen can be applied.
  • the disadvantage of these devices is that only one injection at a time with these devices
  • Insulin type for example normal insulin, long-term insulin or mixed insulin
  • Insulin type can be injected per injection.
  • the invention is based on the task of creating a spraying device of the type mentioned at the beginning with which several liquid therapeutic agents, in particular the above-mentioned insulin types with their individual components in freely selectable mixing ratios, simultaneously or simultaneously or in succession with a single injection can administer.
  • 1 shows a longitudinal section through a spraying device according to the invention with a spray housing with a cannula body which can be attached at one end, with a spray cannula system which is connected to two containers with liquid therapeutic agents arranged in a therapeutic agent container chamber - And dosing and with a Spritzaüsl ⁇ se sensible; 2 shows a cross section through the sprayer along the section line II-II in Fig.l;
  • Spare part 3 shows a cross section through the sprayer along the section line III-III in Fig.l; 4 shows a cross section through a therapeutic agent container chamber with two individual chambers separated from one another by an intermediate wall, in each of which a separate chamber
  • Therapeutic container (a cartridge) is arranged, the cross section of which has the shape of a semicircular surface; 5 shows a cross section through a one-piece therapeutic agent container chamber with two separate therapeutic agent containers, the cross section of which each has the shape of a semicircular surface; 6 shows an enlarged illustration of a spray cannula system in a second embodiment of the spray device according to the invention for connection to three containers arranged spatially next to one another or in a triangle at mutually equal distances, each with different therapeutic agents; 7 shows a cross section through a therapeutic agent container chamber with three individual chambers separated by partition walls, in each of which a separate therapeutic agent container (a cartridge), the cross section of which has the shape of a third circle area (for the second embodiment of the spraying device according to FIG Fig.6); 8 shows a cross section through a one-piece therapeutic agent container chamber with three separate therapeutic agent containers, the cross section of which each has the shape of a third circle area (for the second embodiment of the spraying device according to FIG.
  • FIG. 6 shows an enlarged illustration of a syringe cannula system in a third embodiment of the spraying device according to the invention for connection to four containers arranged spatially next to one another or in a square with mutually equal spacing, each with different therapeutic agents;
  • FIG. 10 shows a cross section through a therapeutic agent container chamber with four individual chambers separated by partition walls.
  • Spare sheet 1 m in each of which a separate therapeutic agent container (a cartridge) is arranged, the cross section of which in each case has the shape of a quarter circle area (for the third embodiment of the spraying device 6 according to FIG. 9);
  • FIG. 11 shows a cross-section through a one-piece therapeutic agent container with four therapeutic agent containers, the cross-section of which each has the shape of a quarter circle surface (for the third embodiment of the spraying device according to FIG. 9);
  • 12 shows a schematic illustration of a further embodiment of the fixing of the cannula body to the container housing by means of a locking system
  • 13 shows a schematic illustration of a further embodiment of the fixing of the cannula body to the container housing by means of a spring clip system (in the manner of a beer bottle closure)
  • 14 shows a schematic illustration of a further embodiment of the fixing of the cannula body to the container housing by means of a spring ring system
  • Liquid / therapeutic agent container shows a schematic illustration of a piston of the refillable liquid / therapeutic agent container according to FIG. 15;
  • FIG. 17 shows a schematic representation of the front part of a spraying device with a cannula body which can be displaced along the longitudinal axis in order to interrupt the supply of liquid (in the open position);
  • FIG. 18 shows a representation of the front part of the spraying device corresponding to the representation in FIG.
  • 17 (in the closed position); 19 shows a schematic illustration of the front part of a spraying device with a cannula body which can be rotated about the longitudinal axis in order to interrupt the supply of liquid (in the opening division) and 20 shows a schematic representation of the front part of a spraying device with a cannula body rotatable about the longitudinal axis and an additional closing body which can be inserted into the spraying cannula in the direction of the arrow X from the rear of the spraying device to interrupt the
  • Liquid supply (in the open position).
  • a spray device 1 has a spray cannula system 5 which can be attached to one end 3 of the same and is arranged in a cannula body 4, a cup-shaped container housing 6 with two therapeutic agent container chambers (cartridge chambers) 7, 8 for receiving one container each ( a cartridge) 9, 10 with liquid therapeutic agents and two counting and metering units 12, 13 arranged and stored in a housing element 11, each with a triggering device 14, 15 at the other end 16 of the spraying device 1.
  • a spray cannula system 5 which can be attached to one end 3 of the same and is arranged in a cannula body 4, a cup-shaped container housing 6 with two therapeutic agent container chambers (cartridge chambers) 7, 8 for receiving one container each ( a cartridge) 9, 10 with liquid therapeutic agents and two counting and metering units 12, 13 arranged and stored in a housing element 11, each with a triggering device 14, 15 at the other end 16 of the spraying device 1.
  • the cannula body 4 which is preferably made of plastic or the like, has an essentially fully cylindrical part 2.
  • the syringe cannula system 5 is embedded in such a way that the cannula tip 18 protrudes at one end on the front shoulder surface 26 and at the other end two feed channels 19, 20 protrude from the cannula body 4 on the rear shoulder surface 27.
  • An axially extending annular extension 21 is connected to part 2 on the side on which the feed channels 19, 20 protrude.
  • the feather keys 24, 25 can also be integrally formed on the extension 21 and can be designed to protrude accordingly.
  • the container housing 6 has a container base 28 with an axially front outer surface 29 and an axially rear inner surface 30.
  • the container bottom 28 has two bores 36, 37 penetrating it in the axial direction.
  • ErsaizbJatt Container bottom 28 is connected to a step-shaped, approximately ring-cylindrical container wall 31.
  • two diametrically arranged grooves 34, 35 which run in the longitudinal direction are preferably formed.
  • An external thread 40 is formed on the outer surface 38 of the next second step region 39.
  • the outer lateral surface 41 of the next third step area 42 is preferably designed as a knurled surface for better handling of the spraying device 1.
  • An external thread 45 is formed on the outer lateral surface 43 of the next fourth step region 44.
  • two diametrically arranged grooves 48, 49 are formed on the outer lateral surface 46 of the next fifth step area 47 of the container wall 31.
  • the inside of the container housing 6 preferably has two therapeutic agent container chambers (cartridge chambers) 7, 8 starting from the container base 28 and preferably separated from one another by a partition 50.
  • the interior of the container housing 6 preferably has two or more therapeutic container chambers (cartridge chambers) 7, 8 starting from the container base 28, optionally separated from one another by a partition 50.
  • the housing element 11 is also essentially cup-shaped and has a housing base 51 with an axially outer housing base surface 52 and an axially inner housing base surface 53.
  • a housing base 51 with an axially outer housing base surface 52 and an axially inner housing base surface 53.
  • the Man ⁇ telinnen Chemistry 56 preferably two longitudinally verlau- Fende, preferably Diame "tral arranged grooves 57,58 made ⁇ forms, in each of which a feather key is inserted 59.60.
  • the parallel keys 59, 60 can also be formed in one piece with the housing element 11.
  • the housing base 51 has two bores 61, 62 which penetrate it in the axial direction.
  • Counters and metering units 12, 13 are preferably arranged in the interior of the housing element 11 and are preferably detachably fastened in the interior of the housing.
  • the counters and metering units 12, 13 are preferably attached to the inner housing bottom surface 53 of the housing element 11.
  • the triggering devices 14, 15 are preferably piston rods 65, 66 that run in the axial direction and are provided with actuating buttons 63, 64 on one end or on the outside, which are operatively connected to the counting and metering mechanisms 12, 13 and on the other hand or on the inside Printing stamps 67.68 are provided.
  • Further parts of the spraying device 1 according to the invention are a front fixing cap 91, a rear fixing cap 71 and one or more therapeutic agent containers 80.
  • the front fixing cap 91 is a cup-shaped body with a bottom wall 95 having an inner bottom surface 94 and a tubular jacket part 96.
  • the jacket part 96 is provided with an internal thread 92 in the front region of its inside jacket surface.
  • the bottom wall 95 of the fixing cap 91 has a centrally arranged bore 97.
  • the rear fixing cap 71 is a cup-shaped body with a bottom wall 75 having an inner bottom surface 74 and a tubular jacket part 76.
  • the jacket part 76 is provided with an internal thread 72 in the front area of its inner jacket surface.
  • the bottom wall 75 of the fixing cap 71 has a centrally arranged bore 77.
  • Replacement bill and / or the bottom wall 75 of the fixing cap 71 is provided with at least one viewing and actuation opening 78.
  • the commercially available therapeutic agent container 80 consists essentially of a-a as a piece of pipe with two openings 81, 82.
  • the filled therapeutic agent container 80 is provided at its opening 81 facing the feed channels 19, 20 with a pierceable or perforable membrane 87 and at its opening 82 facing the plunger 67 of the triggering device 14 with a closure which can be displaced in the tube piece, in particular with a piston 83, closed.
  • the therapeutic agent containers used with the spraying device 1 according to the invention can not only be round in cross-section, but also, according to the invention, in other cross-sectional shapes, for example semicircular, third or quarter-circular , be trained.
  • the container designed in this way can keep the space to be provided in the spraying device 1 for the container chambers 9, 10 for the therapeutic agent containers to be accommodated.
  • the external dimensions (length and diameter) of the spraying device 1 according to the invention can also be kept small, which improves the possibilities of its storage and its manageability.
  • the spraying device in such a way that the counting and dosing of different therapeutic agents contained in different therapeutic agent containers 9, 10 are carried out with only a single counting and metering unit.
  • electrical servomotors which are controlled by permanently programmed or freely programmable microprocessors, instead of springs or spring motors, to control and drive the counting and metering devices.
  • microelectronics in the field of correct dosing of therapeutic agents It is particularly recommended for spraying devices that are used by (especially young or old) patients who inherently have problems handling technical equipment properly.
  • the "counting" is carried out by a mini-computer, the "dosing" by an electric servomotor.
  • a built-in rechargeable battery which can be charged by means of solar cells or via power packs at each socket, provides the necessary power supply.
  • the container housing 6 is "loaded” with two therapeutic agent containers 9, 10, that is to say two containers 9, 10 are inserted into the container chambers 7, 8 of the container housing 6 in the insertion direction E until the front channels ten of the containers 9, 10 come to rest on the inner surface 30 of the container bottom 28.
  • the housing element 11 is then attached to the step region 47 of the container wall 31 of the container housing 6, the feather keys 59, 60 arranged on the region 54 of the jacket wall 55 of the housing element 11 in the step region 47 of the container wall 31 of the container housing 6 trained grooves 48.49 are fitted.
  • the housing element 11 is arranged in a rotationally fixed manner with respect to the container housing 6.
  • the two pressure stamps 67, 68 of the piston rods 65, 66 lie exactly in front of the openings 81, 82 and the displaceable closures 83, 84 of the two therapeutic agent containers 9, 10 arranged there.
  • the feather keys 24, 25 of the cannula body 4 and the grooves 34, 35 of the container housing 6 are aligned or arranged or positioned such that the feed channels 19, 20 of the spray cannula system 5 are exactly in front of those on the container bottom 28 of the container housing 6 formed bores 36, 37 and in front of the openings 85, 86 lying immediately behind the bores 36, 37 and the pierceable or perforable membranes 87, 88 of the therapeutic agent containers 9, 10 arranged there.
  • a protective cap 99 is placed over the injection cannula 18 protruding from the front fixing cap 91.
  • Ers is inserted in order to protect the user from injuries and to protect the injection cannula 18.
  • the disassembly of the spraying device 1 according to the invention is generally carried out in reverse order for cleaning, maintenance or refilling purposes.
  • only the cannula body 4 can also be removed by removing only the front fixing cap 91 for renewal.
  • only the cannula body 4 remains on the spraying device 1, only the rear part of the spraying device 1 can be opened, for example in order to replace one or both therapeutic agent containers 9, 10 or the counters and metering units 12, 13 to clean, adjust or repair.
  • Figs. 4, 5, 7, 8, 10 and 11 end views of therapeutic containers 9, 10 ... are shown, from which it can be seen that these are not necessarily round, but definitely also other, in particular semi, third, quarter circle surfaces - Can have chen-shaped cross sections.
  • the containers 9, 10 ... can be separate containers, but they can also be integrated in reservoirs made in one piece, which have special containers, each with a half, third, quarter circle cross-section, in which the same or different therapeutic agents, in particular various insulins are included.
  • the liquid / therapeutic agent containers should be designed to be refillable.
  • a refill valve device 89 is provided on the therapeutic agent container.
  • a chamber 90 which is filled with a sterilizing agent and is even closed off by a piston is provided for re-usability in front of and / or behind a piston 83, the sterilizing agent during the filling process; the therapeutic agent container wall is wetted.
  • the piston 83 itself can be constructed in such a way that it contains the sterilizing agent and / or contains chambers 90 for the sterilizing agent.
  • a blood glucose meter can be structurally integrated in the insulin injection device, wherein a microprocessor can be used for the blood glucose measurement, which also includes the control unit for the required display elements and dose measurements and / or delivered doses and / or piston displacements.
  • Both the measured blood sugar values and the insulin doses delivered can be called up and / or transmitted at the appropriate times, both in the viewing / display window of the syringe / blood glucose meter and to / from a PC / AT or terminal (bidirectional data transmission from measuring device to PC / AT and PC / AT measuring device possible).
  • the insulin syringe / blood glucose meter contains a dosing calculation program which is also patient-oriented and / or makes a modified dosing proposal to the patient, the modified program being loadable / transferable to the 1 insulin syringe / blood glucose meter at any time on a PC / AT terminal is.
  • Closure device body or the cannula holder itself
  • Replacement b be provided by which the connection between the feed channels 19, 20 and the injection needle or syringe cannula 18 can be interrupted.
  • a cannula body 112 (possibly loaded by a spring 113) is arranged and supported in a housing 129 along the longitudinal axis L of the spraying device in the arrow directions X-Y.
  • the liquid supply from the supply channels 119, 120 to the injection needle or spray cannula 118 can be interrupted by a body formed on the cannula body 112, preferably by the cannula 111 itself.
  • a (possibly spring-loaded) cannula body 114 is provided, which is designed and arranged to be rotatable about the longitudinal axis L of the spraying device.
  • the liquid supply from the supply channels 119, 120 to the injection needle or spray cannula 118 can be interrupted via a channel system 115, which is formed in the cannula body 114 and in the housing 116 accommodating the cannula body 114.
  • the twisting of the cannula body 114 can take place in particular by means of a closure cap (not shown here) which protects the cannula tip of the spraying device.
  • a (possibly spring-loaded) cannula body 117 can be displaced along the longitudinal axis L of the spraying device in the arrow directions X-Y and can be rotated and arranged about the longitudinal axis L of the spraying device.
  • the liquid supply from the supply channels 119, 120 to the injection needle or syringe cannula 118 can be interrupted by a body 121 formed on the cannula body 117 and by a channel system 122, which is formed in the cannula body 117 and in the housing 123 receiving the cannula body 117 become.
  • the closure device or the body 121 should be of the
  • the closure device or the body 111 can be actuated from the front of the spraying device, that is to say from the needle tip 118.
  • the cannula body 112 is preferably attached to a spring plate 124 which is supported on a shoulder 125 of a housing part 126.
  • the housing part 126 is in turn with a
  • the (compression) spring 113 is clamped between the housing part 126 and the housing element 127.
  • the spring 113 presses the spring plate 124 against the shoulder 125 in the direction of the arrow X.
  • the cannula body 112 is, as shown in FIG. 18, by means of a closure cap 128
  • the force of the spring 113 is displaceable in the direction of the arrow Y, which presses against the cannula body 112 in the direction of the arrow Y when screwing onto the housing 129 of the spraying device.
  • the injection needle 118 of the injection system 130 is detachably attached to the cannula body 112, preferably screwed 131, as shown in FIGS. 17, 18 show.
  • closure device closing the feed channels 119, 120 in the inoperative position of the spraying device or the body could also be attached directly to the closure cap 128. Since the closure device or the body must be made very thin, there is a risk that this (r) improper
  • the locking devices 111, 121 could, however, also be operable from the longitudinal side of the spraying device with a corresponding structural design. 35
  • the closure devices 111, 121 should advantageously be insertable at the mouth of the feed channels 119, 120 into the injection channel 132, as shown in FIGS. 17, 18, 20.
  • an injection and closure position can be realized, in which not only the mixing of the liquids, but also an airtight seal is ensured.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un appareil pour l'injection de quantités dosées d'agents thérapeutiques liquides, notamment d'insuline, comprenant une enveloppe pour récipients, une canule d'injection raccordée de façon amovible à un récipient d'agent thérapeutique disposé dans ladite enveloppe pour récipients, un compteur et un doseur pour le comptage et le dosage de la quantité d'agent thérapeutique à appliquer, ainsi qu'un dispositif de déclenchement destiné à expulser l'agent thérapeutique à travers la canule d'injection, appareil dans lequel plusieurs récipients (9, 10) remplis de divers agents thérapeutiques, notamment de diverses sortes d'insuline, sont disposés dans l'enveloppe pour récipients (6); la canule d'injection (17) fait partie d'un dispositif de canule d'injection (5) logé dans/ou sur un corps de canule (4), dispositif présentant un élément d'injection (18) et une pluralité de canaux d'amenée (19, 20) débouchant dans l'élément d'injection (18), s'étendant éventuellement jusqu'à la pointe de la canule (18a), les extrémités des canaux d'amenée (19, 20) étant conformées à arêtes vives en vue du percement de la membrane (87) des récipients d'agents thérapeutiques (9, 10), ou étant raccordables autrement, en particulier par l'intermédiaire d'un ensemble de tuyaux souples ou analogues, auxdits récipients d'agents thérapeutiques (9, 10), au moins un compteur et un doseur (12, 13) ou, le cas échéant, un nombre de compteurs et de doseurs (12, 13) correspondant au nombre de récipients d'agents thérapeutiques (9, 10) étant prévus.
EP19900910109 1989-07-08 1990-07-09 Appareil pour l'injection de quantites dosees de divers agents therapeutiques liquides Withdrawn EP0433422A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE8908349U 1989-07-08
DE8908349 1989-07-08

Publications (1)

Publication Number Publication Date
EP0433422A1 true EP0433422A1 (fr) 1991-06-26

Family

ID=6840915

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19900910109 Withdrawn EP0433422A1 (fr) 1989-07-08 1990-07-09 Appareil pour l'injection de quantites dosees de divers agents therapeutiques liquides

Country Status (5)

Country Link
EP (1) EP0433422A1 (fr)
JP (1) JPH04500622A (fr)
AU (1) AU5930990A (fr)
DE (5) DE9010361U1 (fr)
WO (1) WO1991000748A1 (fr)

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PL214940B1 (pl) * 2009-07-31 2013-09-30 Lozano Platonoff Alberto Mechanizm wskaznikowy automatycznego aplikatora, zwlaszcza do insuliny
WO2012072556A1 (fr) * 2010-11-29 2012-06-07 Sanofi-Aventis Deutschland Gmbh Composant d'interface de distribution pour un dispositif d'administration de médicaments
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Also Published As

Publication number Publication date
DE9090119U1 (de) 1992-10-08
DE4021809C2 (de) 1995-01-26
JPH04500622A (ja) 1992-02-06
DE4090909D2 (en) 1992-04-23
DE4090909A1 (fr) 1992-04-23
DE4021809A1 (de) 1991-02-28
AU5930990A (en) 1991-02-06
DE9010361U1 (de) 1991-02-07
WO1991000748A1 (fr) 1991-01-24

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