DK166129B - Kateter - Google Patents
Kateter Download PDFInfo
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- DK166129B DK166129B DK583083A DK583083A DK166129B DK 166129 B DK166129 B DK 166129B DK 583083 A DK583083 A DK 583083A DK 583083 A DK583083 A DK 583083A DK 166129 B DK166129 B DK 166129B
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- catheter
- end piece
- distal end
- wall
- catheter according
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/0069—Tip not integral with tube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Pulmonology (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Biophysics (AREA)
- Child & Adolescent Psychology (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Description
i
DK 166129B
Opfindelsen angår et kateter, som angivet i krav l's indledning.
Ved anvendelse af sådanne katetre indføres disse i et legemes karsystem for f.eks. at indføre strålingsuigennemtrængelige kontrastmidler til diagnosticering eller medikamenter som en del af en behandling. Disse katetre består sædvanligvis af bøjelige plastslanger med en bestemt lille diameter, der er betydeligt mindre end tværsnittet af det kar, som katetret skal føres igennem. Ved andre former for katetre, der anvendes i forbindelse med hjertepacemakere, består kateteret af en bøjelig kappe, der omgiver elektriske ledere, som ved den distale ende ender i en eller flere overfladeelektroder, der kan bringes i berøring med endocardialt væv. Disse kendte angiografiske eller diagnostiske katetre består sædvanligvis af polyethylen, polyurethan, polypropylen, silikonegummi eller et andet ikke-trombogent materiale. For at katetrene skal kunne føres gennem karsystemet uden bule- eller foldedannelser, skal det have en vis vægtykkelse og hårdhed. Dette medfører imidlertid fare for beskadi gelse af karvævet, navnlig dersom katetrets distale ende er stump eller har en skarp kant. Der er således allerede sket uheld, hvor et kateter med lille diameter og en skarpkantet ende er trængt gennem aortavæggen og har forårsaget patientens død.
Fra DE Al 28 18 119 kendes et kateter, der især tjener til katete- ' risering af urinblæren. Dette kateter består af en bøjelig slange, der ved sin distale ende har et afsnit med en dobbeltvæg, således at der i hele dette afsnit er dannet et ringformet hulrum i selve slangematerialet. Ved indførsel af et fluid under tryk i dette hulrum i slangematerialet pumpes det yderste afsnit af katetrets distale ende op og danner en tragt, der indmunder i katetrets hovedkanal. Herved kan det indførte kateters distale ende fastholdes i en fast stilling i et hulrum i legemet. Hertil træder tragtens udvendige flader i berøring med legemsvævet i legemets hulrum. Imidlertid medfører den fremspringende tragtring en fare for beskadigelse af legemsvæv ved katetrets glidning gennem karsystemet.
Trods den forøgede udvendige diameter af katetret opnås der ingen fordelagtig fordeling af den kraft, som et kateter på dets vej ind i et legemshulrum udøver på karvæggene.
Fra DE Al 28 47 633 kendes et kateter, der består af et indvendigt
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2 og et udvendigt rør, der teleskopagtigt kan skydes ind i hinanden og bevæges aksialt i forhold til hinanden. Til de to rørs distale ender er der fastgjort en ballon, der ved ændring af afstanden mellem de to rørs distale ender kan opblæses til en ønsket form. Et sådant kateter tjener navnlig til ekstraktion eller fjernelse af fremmedlegemer eller fremmedstoffer, såsom galdeslam eller galdesten fra et legeme. Dette kateter har i dets grundstilling en cylindrisk form, hvor fastgørelsen af en ballon til ydersiden af de to rør ved deres distale ender udgør en alvorlig fare for beskadigelse af legemsvæv.
Den teleskopagtige indskydning af de to rør i hinanden medfører desuden fare for indklemning af legemsvæv mellem rørene.
Fra US patentskrift 43 85 635 kendes endvidere et angiografi-kateter bestående af en bøjelig slange, der ved sin distale ende har et blødt endeafsnit. Endefladen af dette afsnit er plan og forløber vinkelret på katetrets længdeakse. Selv om dette kateter er udformet med et blødt endeområde, har dets distale ende stadig stumpe kanter, der udgør en fare for beskadigelse af karsystemet og vanskeliggør indførslen af katetret gennem karsystemets kar. Dertil kommer, at den flade, som katetrets distale ende frembyder til fordeling af kræfter, som katetret udøver på karvæggene, er lille.
Formålet med opfindelsen er derfor at tilvejebringe et kateter af den i krav l's indledning angivne art, ved hvilket faren for beskadigelse af legemsvæv er minimal.
Denne opgave løses ifølge opfindelsen ved hjælp af et kateter med de i krav l's kendetegnende del angivne ejendommeligheder.
Opfindelsen forklares nærmere i det følgende under henvisning til de på tegningen anskuel iggjorte udførelsesformer. På tegningen viser:
Fig. 1 det distale endeafsnit af et kendt angiografisk eller diagnostisk kateter, fig. 2 et længdesnit gennem et kateter med et derpå fastgjort oppusteligt endestykke, fig. 3 et længdesnit gennem et kateter med et oppusteligt endeaf-
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3 snit af ikke-strækbart materiale, samt en anordning, ved hjælp af hvilken endestykket over en kanal kan betjenes med et fluid, fig. 4 et længdesnit gennem et angiografisk kateter med et sammentrykkel igt endestykke i dets ikke-sammentrykte stilling, fig. 5 det i fig. 4 viste angiografiske kateter med endestykket i sammentrykket stilling, og fig. 6 et snit gennem yderligere en udførelsesform for et deformerbart endestykke til et kateter.
Fig. 1 viser et længdesnit gennem den distale ende af et kendt angiografisk kateter, der består af en længde af en bøjelig plastikslange 10 med en central kanal 11, der strækker sig i hele katetrets længde fra dettes (ikke viste) proximale ende til dets distale ende 12. Angiografiske farvestoffer eller andre medikamenter kan indføres i katetrets ved dettes proximale ende, der befinder sig uden for legemet og over kanalen 11 føres til et bestemt sted i legemet, ved hvilket katetrets distale ende 12 befinder sig.
Det i fig. 1 viste kateters distale ende 12 har en brat afslutningskant 13, der er forholdsvis skarp. For at kunne indføres i karsystemet, skal katetret have en vis stivhed, hvilket medfører, at katetrets skarpe afslutningskant, når katetret føres gennem karsystemet, kan forårsage beskadigelse af karvævet, navnlig af dettes endoteliale lag (tunica intima).
Til eliminering af dette problem er kateteri egernet 10 ifølge en første i fig. 2 vist udførelsesform udformet med to kanaler, nemlig den centrale kanal 11, som angiografiske farvestoffer eller andre væsker kan strømme igennem, og en anden kanal 14, der strækker sig i hele katetrets længde. Ved den distale ende af kateteri egernet 10 befinder der sig et bøjeligt oppusteligt ballonagtigt endestykke 15, der består af ikke-strækbart materiale og i ekspanderet tilstand antager en i det væsentlige torusformet form. Kanalen 14 står i forbindelse med det indvendige hulrum i det torusformede endestykke 15, medens kanalen 11 står i forbindelse med det torusformede
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4 endestykkes centrale åbning. Væske, der indføres i katetret ved dettes proximale ende kan strømme gennem katetrets centrale kanal 11 og ud gennem åbningen 17 i det bløde bøjelige endestykke 15, medens fluid, der indføres i kanalen 14, strømmer ind i endestykkets ringformede kammer 16 og bevirker en oppustning af endestykket 15. Endestykket 15 dannes fortrinsvis af en bioaksialt orienteret eller tværbunden polyolefinfolie og kan have en tykkelse i størrelsesordenen 25,4-63,5 /an. I ikke-oppustet eller evakueret stilling er endestykket 15 ikke i besiddelse af nogen stivhed og lægger sig ind mod kateterlegemet 10's endestykke og svarer i det væsentlige til dettes form. Når endestykkets indvendige rum på egnet måde sættes under tryk, ekspanderer endestykket og forøger derved på ønsket måde berøringsområdet mellem katetrets ende og legemsvæv, som kateterenden eventuelt støder imod under katetrets indførsel i legemet eller ved dets anbringelse i dette. Graden af det ballonagtige endestykkes oppustning bestemmer graden af endestykkets blødhed eller deformer- barhed. Dermed har lægen mulighed for at afpasse egenskaberne af katetrets endestykke, således at beskadigelse af væv reduceres til et minimum.
Det ringformede ballonagtige endestykke 15 fremstilles fortrinsvis separat og fastgøres derefter ved termisk eller kemisk klæbning til kateterlegemet. Endestykket kan dog også være udformet som et hulrum i væggen ved den distale ende af katetret, således at selve katetrets væg buler udad ved indførsel af et trykfluid i hulrummet.
Fig. 3 viser en alternativ udførelsesform med en udvidelig elastomer manchet 18 til styring af trykket i det indvendige hulrum i det ikke-strækbare endestykke 15. Den udvidelige elastomere manchet 18 kan være anbragt et sted langs længden af kateteri egernet 10 og er fortrinsvis anbragt ved den yderste proximale ende af katetret ved et sted, der efter katetrets indførsel i legemet befinder sig uden for dette. Den elastomere manchet 18 er fortrinsvis anbragt i en udvendig ringformet udsparing i kateterlegemet 10 og er som vist ved 19 og 20 ved sine endekanter forbundet fluidtæt med kateteri egernet 10, f.eks. ved klæbning. En radial boring 21 strækker sig gennem den ringformede udsparings ringbund og indmunder i kanalen 14. Den radiale boring 21 og den del af Kanalen 14, der strækker sig fra boringen 21 og hen til enden af katetret samt kammeret 16 i det
DK 166129B
5 deformerbare endestykke 15 er fyldt med et inkompressibelt fluid. I den fra den radiale boring 21 mod katetrets proximale ende forløbende del af kanalen 14 er der anbragt en egnet prop 22.
Når der udøves en kraft på endestykket 15 ifølge fig. 3, forøges det indvendige tryk i endestykket 15, hvilket bevirker en udbuling af den elastomere manchet 18 og en tilsvarende sammentrykning af endestykket 15. Graden af sammentrykningen er proportional med den på endestykket 15 udøvede kraft, der igen er en funktion af den elastomere manchet 18's "stivhed". En formindskelse af voluminet i endestykket 15 medfører en forøgelse af berøringsområdet mellem dette og en flade, som det trykkes imod. Dersom manchetten 18 er anbragt ved et sted på katetret, der ligger uden for legemet efter katetrets indførsel, kan manchetten på egnet måde forbindes med en signalomformer, der direkte viser fluidtrykket i det system, der forårsager ekspansionen af manchetten 18.
Ved det i fig. 3 viste endestykke dannes den ringformede åbning 17 hensigtsmæssigt af en kraftigere ring 23. Ringen 23 har en udvendig diameter, der ikke er større end den indvendige diameter af et eventuelt indførselsredskab, som katetret skal føres igennem under implanteringen. Ved denne konstruktion kan endestykket 15 tilpasse sig efter et volumen med en mindre diameter end det helt udvidede endestykke 15's diameter, idet en del af det fluid, der befinder sig i hulrummet i endestykket derved kan trykkes tilbage gennem kanalen 14 og tværboringen 21 og ekspandere den elastomere manchet 18.
I praksis kan kanalen 14 have en diameter i størrelsesordenen 50,8-101,6 /im og strække sig fra endestykket 15 og gennem den radiale boring 21. Kanalen 14 kan strække sig helt hen til den proksimale ende af katetret, hvor den elastomere manchet 18 og den radiale boring 21 kan være anbragt.
Ligesom ved den i fig. 2 viste udførelsesform er endestykket 15 frotrinsvis fremstillet af en ikke-strækbar polyolefinfolie og kan have en tykkelse i størrelsesordenen 25,4-63,5 /im.
Ved den i fig. 4 viste udførelsesform har katetret et dertil fastgjort blødt deformerbart endestykke, der er udformet som en
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6 eftergivelig slangeformet mundingsdel 24, der omgiver den distale ende af kateterlegemet 10 og er forbundet med denne ved hjælp af en overlapningsforbindelse og strækker sig et bestemt stykke ud forbi kateterlegemets distale ende. Den bøjelige plastmundingsdel 24 er ikke udformet med konstant vægtykkelse, men er derimod udformet på en sådan måde, at den, dersom den med sin yderste ende 25 med en forudbestemt ringe kraft støder mod et ubevægeligt objekt vil blive sammentrykket og antage den i fig. 5 viste form. Hertil er vægtykkelsen af det afsnit af endestykket, der strækker sig ud forbi enden af kateterlegemet 10, konstant bortset fra et ringformet område 27, hvor væggen har en mindre vægtykkelse, således at der langs en ringformet linie ved dette sted kan ske en foldning af vægmaterialet. På tilsvarende måde foldes det bløde kompressi ble endestykke 24 ved stedet 28 langs den udvendige omkreds af enden af katetret. I stedet for denne mindre vægtykkelse af mundingsdelen til opnåelse af en foretrukken foldelinie er det også muligt at opnå den ønskede foldeevne ved at udforme mundingsdelen på en sådan måde, at vægmaterialet har en mindre stivhed i det ringformede område 27.
Ved egnet valg af hårdheden af plastmaterialet til det bløde sammentrykkel ige endestykke 24 gives dette en "formgenantagelses" -egenskab, således at endestykket, når det ikke længere trykkes mod et fastere objet, genantager den i fig. 4 viste form. Det er, som antydet ved 30 i fig. 4 og 5, fordelagtigt at forøge den materialemængde, der omgiver den centrale åbning 29. Af denne forøgede materialemængde er der dannet en ring, der stabiliserer og forstærker åbningen og forhindrer, at det omgivende område af endestykket klapper indad.
Af fig. 5 ses, at berøringsområdet mellem endestykket og et objekt, som endestykket trykkes mod, forøges ved sammentrykningen af endestykket, hvorved det effektive tryk, som katetret udøver på vævet, formindskes.
Den centrale kanal i katetret kan f.eks. have en diameter på 0,114 cm. Kateterlegemet kan f.eks. have en vægtykkelse på 0,022 cm ved den distale ende. Det i fig. 4 og 5 viste bløde endestykke 24 kan f.eks. have en vægtykkelse på ca. 0,0127 cm, der dog reduceres til en vægtykkelse på ca. 0,010 cm ved den ringformede omkredslinie
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7 27. Endestykket kan i dets ikke-sammentrykte stilling have et ? tværsnitsareal på ca. 0,0077 cm og i dets i fig. 5 viste sammen-trykte stilling have et tværsnitsareal på ca. 0,0265 cm, hvilket er en forøgelse af tværsnitsarealet på 3,41 gange det oprindelige tværsnitsareal.
Ved den i fig. 6 viste udførelsesform er et slangeformet cylindrisk endestykke 31 bestående af si lastik eller et andet blødt deformerbart plastmateriale fastgjort til den distale ende af katetret. Når dette bløde plastendestykke støder mod en hindring, vil det under forøgelse af den udvendige diameter og under bøjningen deformeres og frembyde et større berøringsområde med hindringen.
Claims (9)
1. Kateter (10) bestående af en bøjelig slange med en slangevæg, der omgiver en centralt gennem katetret i hele dettes længde førende kanal (11) og til forøgelse af katetrets (10) diameter ved dettes distale ende kan bøjes udad, kendetegnet ved, at katetret (10) til dets indføring i et levende legemes karsystem har et blødt, deformerbart, slangeformet, til katetrets distale ende fastgjort endestykke (15,24,31), der med dets yderside flugter med ydersiden af kateterslangevæggen og strækker sig ud forbi katetrets (10) distale ende og ved en mod katetrets (10) distale ende rettet trykpåvirkning deformeres og antager en torusform rundt om endestykkets mundingsåbning (17,29), således at berøringsområdet mellem det i et legemes karsystem indførte kateters (10) distale ende og legemsvævet forøges.
2. Kateter ifølge krav 1, kendetegnet ved, at det distale endestykke (15) er udformet som et oppusteligt eftergiveligt ballonelement af et ikke-strækbart materiale og danner en beholder, der ringformet omgiver kateterslangens (10) distale ende (12), og hvis indre rum står i forbindelse med en kanal (14), gennem hvilken der til forøgelse af katetrets (10) vægtykkelse udad i det distale endestykkes (15) område kan indføres et fluid i beholderens indre rum.
3. Kateter ifølge krav 1 eller 2, kendetegnet ved, at endestykket (15) består af en ikke-strækbar polyolefi nfolie.
4. Kateter ifølge krav 1, kendetegnet ved, at det distale endestykke (24) er udformet som en eftergivelig slangeformet mundingsdel med en åbning (29) og i den del, hvormed det strækker sig ud forbi kateterslangens (10) distale ende, har en ringformet zone (27), der danner et foretrukkent foldeområde, i hvilket endestykkets (24) væg bøjes udad, når enden af endestykket (24) trykkes mod en forholdsvis ueftergivelig flade.
5. Kateter ifølge krav 4, kendetegnet ved, at endestykket (24) består af polyurethan. DK 166129B
6. Kateter ifølge et hvilket som helst af kravene 1-5, ken detegnet ved, at åbningen (17,29) begrænses af en forstærkningsring (23,30).
7. Kateter ifølge et hvilket som helst af kravene 2-4, ken detegnet ved, at en manchet (18) af eftergive!igt materiale er anbragt tæt om katetrets bøjelige slangevæg (10) ved et sted i afstand fra endestykket (15), og at der i slangevæggen (10) neden under den eftergivelige manchet (18) er udformet en radial boring (21), der står i forbindelse med kanalen (14).
8. Kateter ifølge krav 7, kendetegnet ved, at den eftergivelige manchet (18) er et elastomert bånd, der omgiver den slangeformede del (10) og dækker den radiale boring (21).
9. Kateter ifølge et hvilket som helst af kravene 4-6, ken detegnet ved, at mundingsdelens (24) udvendige diameter og den udvendige diameter af katetrets bøjelige, slangeformede del er ens.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US52099683 | 1983-08-08 | ||
US06/520,996 US4531943A (en) | 1983-08-08 | 1983-08-08 | Catheter with soft deformable tip |
Publications (4)
Publication Number | Publication Date |
---|---|
DK583083D0 DK583083D0 (da) | 1983-12-16 |
DK583083A DK583083A (da) | 1985-02-09 |
DK166129B true DK166129B (da) | 1993-03-15 |
DK166129C DK166129C (da) | 1993-08-09 |
Family
ID=24074909
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK583083A DK166129C (da) | 1983-08-08 | 1983-12-16 | Kateter |
Country Status (9)
Country | Link |
---|---|
US (1) | US4531943A (da) |
JP (1) | JPS6040069A (da) |
CA (1) | CA1207206A (da) |
DE (1) | DE3341850A1 (da) |
DK (1) | DK166129C (da) |
FR (1) | FR2550454B1 (da) |
GB (1) | GB2144635B (da) |
IT (1) | IT1171896B (da) |
NL (1) | NL187049C (da) |
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EP0273618A3 (en) * | 1986-12-23 | 1989-09-13 | BAXTER INTERNATIONAL INC. (a Delaware corporation) | Soft tip catheter |
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US4867174A (en) * | 1987-11-18 | 1989-09-19 | Baxter Travenol Laboratories, Inc. | Guidewire for medical use |
JPH01227766A (ja) * | 1988-03-04 | 1989-09-11 | Yuichi Furukawa | 血管造影用カテーテル |
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US5078702A (en) * | 1988-03-25 | 1992-01-07 | Baxter International Inc. | Soft tip catheters |
US4898591A (en) * | 1988-08-09 | 1990-02-06 | Mallinckrodt, Inc. | Nylon-PEBA copolymer catheter |
DE3833361C2 (de) * | 1988-09-30 | 1996-07-11 | Hohla Kristian | Katheter für die Angioplastie |
JP2729275B2 (ja) * | 1988-10-05 | 1998-03-18 | 則雄 大工園 | レーザ光による加温装置 |
US5017259A (en) * | 1988-10-13 | 1991-05-21 | Terumo Kabushiki Kaisha | Preparation of catheter including bonding and then thermoforming |
US4990138A (en) * | 1989-07-18 | 1991-02-05 | Baxter International Inc. | Catheter apparatus, and compositions useful for producing same |
US4976690A (en) * | 1989-08-10 | 1990-12-11 | Scimed Life Systems, Inc. | Variable stiffness angioplasty catheter |
US5019040A (en) * | 1989-08-31 | 1991-05-28 | Koshin Sangyo Kabushiki Kaisha | Catheter |
US5024655A (en) * | 1989-09-05 | 1991-06-18 | Freeman Andrew B | Epidural catheter apparatus and associated method |
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IT8349583A0 (it) | 1983-12-27 |
DE3341850A1 (de) | 1985-02-28 |
DE3341850C2 (da) | 1990-08-09 |
CA1207206A (en) | 1986-07-08 |
GB2144635B (en) | 1987-04-23 |
NL187049C (nl) | 1991-05-16 |
DK583083A (da) | 1985-02-09 |
JPS6040069A (ja) | 1985-03-02 |
IT1171896B (it) | 1987-06-10 |
FR2550454A1 (fr) | 1985-02-15 |
NL8303940A (nl) | 1985-03-01 |
FR2550454B1 (fr) | 1988-07-15 |
JPH0128588B2 (da) | 1989-06-05 |
GB8330312D0 (en) | 1983-12-21 |
DK166129C (da) | 1993-08-09 |
US4531943A (en) | 1985-07-30 |
DK583083D0 (da) | 1983-12-16 |
GB2144635A (en) | 1985-03-13 |
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