DK169376B1 - Kateterballon, fremgangsmåde til fremstilling heraf, og udvidelsesballonkateter omfattende en sådan kateterballon - Google Patents
Kateterballon, fremgangsmåde til fremstilling heraf, og udvidelsesballonkateter omfattende en sådan kateterballon Download PDFInfo
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- DK169376B1 DK169376B1 DK328384A DK328384A DK169376B1 DK 169376 B1 DK169376 B1 DK 169376B1 DK 328384 A DK328384 A DK 328384A DK 328384 A DK328384 A DK 328384A DK 169376 B1 DK169376 B1 DK 169376B1
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- balloon
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- catheter
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- stretched
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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
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
- Y10T428/139—Open-ended, self-supporting conduit, cylinder, or tube-type article
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
- Y10T428/1397—Single layer [continuous layer]
Description
DK 169376 B1 i
Den foreliggende opfindelse angår en kateterballon af fleksibel polymer, en fremgangsmåde til fremstilling af en sådan ballon og et udvidelsesballonkateter omfattende en sådan kateterballon.
5 I "Nonoperative Dilatation of Coronary Artery Stenoses - Percutaneous Transluminal Coronary Angioplasty", The New England Journal of Medicine, bd. 301, nr. 2, side 61-68, 12. juli 1979, omtaler Griintzig en forbedret teknik ved brug af et udvidelseskateter til afhjælpning af arteriel 10 stenose. ifølge Griintzig m.fl. indførtes teknikken med transluminal angioplasti til behandling af atherosclerotisk·· .obstruktion af arteria fémoralis først i 1964 af Dotter og Judkins.
Brugen af ballonkatetere er ikke begrænset til af-15 hjælpning af arteriel stenose, men har vist sig anvendelig til mange medicinske formål, herunder ikke blot indførelse i blodkar, men også indførelse i en række forskellige legemshulheder .
Der findes, især i USA, en betydelig mængde litteratur 20 vedrørende anvendelse af ballonkatetere og deres fremstilling. Som eksempler kan nævnes USA patent skrifterne nr. 4.093.484, 4.154.244 og 4.254.774. Balloner kan fremstilles af en række forskellige materialer, som i reglen er af den termoplastiske polymertype. Blandt materialer, der er omtalt 25 i de ovennævnte patentskrifter, kan nævnes ethylen/butylen/-styren-blokcopolymére blandet med polystyren med lav molekylvægt og eventuelt polypropylen og lignende sammensætninger, hvor der anvendes butadien eller isopren i stedet for ethylen og butylen; poly(vinylchlorid); polyurethaner; copolyestere? 30 termoplastiske gummisorter; silicone/polycarbonatcopolymere og ethylen/vinylacetatcopolymere.
Opfindelsen angår en kateterballon af fleksibel polymer, hvilken ballon er ejendommelig ved, at polymeren er en højmolekylær, biaksialt orienteret polyethylenterephthalat-35 homo- eller copolyester med et grænseviskositetstal på 0,8- 1,1, bestemt ifølge ANSI/ASTM D 2857-70.
2 DK 169376 B1
Opfindelsen angår endvidere en fremgangsmåde til fremstilling af en kateterballon ifølge opfindelsen, hvilken fremgangsmåde er ejendommelig ved, at et rør af polyethylen-terephthalat-homo- eller copolyesteren, fortrinsvis en poly-5 ethylenterephthalat-(PET)-homopolyesterrør med en endelig længde (¾) og en indvendig diameter (ID), der fortrinsvis er ca. halvdelen af den udvendige diameter (OD), ved en temperatur i intervallet fra overgangstemperaturen af anden orden til overgangstemperaturen af første orden, fortrinsvis 10 en temperatur på 84-99ec, især 86-96eC, strækkes til en længde (L2), der er 3-6 L^, og at det strakte rør med en indvendig diameter ID^ og en udvendig diameter OD^ ved hjælp af gas eller væske under tryk derefter udvides til en indvendig diameter (ID2), som er 6-8 ID, og en udvendig diameter 15 (0D2), der fortrinsvis er 3-4 OD, efterfulgt af afkøling af det strakte og udvidede rør til under dets overgangstemperatur af anden orden.
Opfindelsen angår endelig også et udvidelsesballonkateter, som er ejendommeligt ved, at det omfatter en kateter-20 ballon ifølge opfindelsen.
Kateterballonerne ifølge den foreliggende opfindelse udviser en overlegen trækbrudstyrke i forhold til de kendte balloner. De kan derfor fremstilles med mindre vægtykkelser end dem, der almindeligvis anvendes til balloner, og kan 25 på grund af deres fleksibilitet og tynde vægge lettere klap-pes sammen og lettere kan transporteres i kroppen. I forhold til kendte balloner udviser kateterballonerne ifølge opfindelsen endvidere en meget ringe radial forlængelse eller krybning, her kollektivt omtalt som radial udvidelse, når 30 de pustes op til det tryk, der er nødvendigt for at udføre den ønskede lægelige procedure.
Opfindelsen vil i det følgende blive forklaret under henvisning til tegningen, på hvilken fig. 1 i snit viser den bageste halvdel af en form, 35 en ballon, og rørledninger og tilhørende dele i et apparat, der kan anvendes til dannelse af en ballon ifølge opfindelsen 3 DK 169376 B1 ud fra strakt polymerslange, og fig. 2 viser den radielle udvidelse (%) og bristnings-trykket (MPa) for tre balloner ifølge opfindelsen C, D og E sammenlignet med radiel udvidelse (%) og bristningstryk 5 (MPa) for to kendte balloner A og B.
Den ved fremgangsmåden ifølge opfindelsen dannede kateterballon har et bristningstryk, dvs. det indvendige tryk, ved hvilket ballonen brister, på mindst 1,4 MPa og en radiel udvidelse ud over nominel oppustet diameter på mindre 10 end 5% ved 1,4 MPa, og den foretrukne PET-homopolymer efter omdannelse til rør og ballon har et grænseviskositetstal på 0,8-1,1. Det foretrukne rør kan i reglen dannes ved gængs ekstrus ionsteknik ud fra PET-homopolyesterharpiks med et grænseviskositetstal på 1,0-1,3 og en massefylde på 1,35-15 1,45 g/cm3. Ballonen ifølge opfindelsen udviser en usædvan lig kombination af filmegenskaber såsom sejhed, fleksibilitet og trækbrudstyrke. Således har ballonen ifølge opfindelsen et bristningstryk på mindst 1,4 MPa, fortrinsvis mindst 2,8 MPa, især mindst 3,5 MPa ved omgivelsernes temperatur (20°C). 20 Desuden har ballonen ifølge opfindelsen en radiel udvidelse udover den nominelle oppustede diameter på mindre end 5% ved et tryk på 1,4 MPa og mindre end 10% ved et tryk på 2,8 MPa. På tegningens fig. 2 vises bristningstryk som funktion af radiel udvidelse for to balloner A og B, der fås på marke-25 det, og som består af poly(vinylchlorid) og for tre balloner C, D og E ifølge opfindelsen og som består af PET-homopoly-ester. Ballonerne A og C har en nominel udvendig diameter på 3,7 mm, ballonerne B og D på 5,0 mm, og E på 6 mm. Vægtykkelserne for A-E er hhv. ca. 0,028, 0,038, 0,028, 0,038 og 30 0,045 mm. De radielle udvidelsesdata for ballonerne ifølge opfindelsen beregnes ud fra den velkendte membranligning σ2 = pr/h, hvor σ2 er trækstyrken af membranen, p er det påførte tryk, r er radius, og h er vægtykkelse, jf. S. Timoshenko, "Strength of Materials", del 2, 2. udg., side 165, D. van 35 Nostrand Company, Inc., New York, New York (1941), og den maksimale forlængelse målt på flade folieprøver, som på DK 169376 B1 4 lignende måde er biaksialt orienterede. Lignende beregninger foretages for poly(vinylchlorid)-balloner med undtagelse af, at der anvendes kendte data til den maksimale forlængelse. Det fremgår, at bristningstrykkene for ballonerne 5 ifølge opfindelsen er hhv. 3,2, 3,4 og 3,5 gange så høje som for de kendte balloner. Med hensyn til data for brist-ningstryk og radial udvidelse, der er angivet her, bestemmes radiel udvidelse fra det punkt, hvor ballonen er under så stort tryk, at den er uden folder, dvs. efter at den er 10 oppustet fra sammenklappet stilling til den nominelle oppustede diameter? et gastryk på 0,5-0,7 MPa er nødvendigt for at nå denne første udvidede form med PET-homopolyesterbal-Ionen ifølge opfindelsen. Almindeligvis kan der fremstilles en ballon med større styrke ud fra polymerrøret ved at ar-15 bejde ved højere strækningsforhold, dvs. i den øverste ende af stræknings- og udvidelsesforholdene. Den således fremstillede ballon har lavere forlængelse, hvilket afspejles i lavere udvidelsesværdier ved et givet oppustningstryk sammenlignet med en ballon fremstillet ved lavere strækningsbetin-20 gelser.
Grænseviskositetstallet bestemmes her ved hjælp af ANSI/ASTM D 2857-70 og massefylden ved hjælp af ASTM D 1505. Bristningstrykket bestemmes ved en enkel laboratorieprocedu-re, hvorved den ene ende på polymerballonen lukkes af, og 25 der indføres gas under tryk trinvis i den anden ende. Oppustningstrykket, ved hvilket ballonen brister ved ca. 20°C (omgivelsernes temperatur), omtales heri som bristningstrykket.
Den fremgangsmåde, ved hvilken ballonen fremstilles, 30 kan udføres på gængs måde med gængs udstyr ved hjælp af en specialpolymer som fabrikationsmateriale. Således strækkes et rør af polymeren med passende dimensioner først ved passende temperatur fra en længde L]_ til en længde L2. Det strakte rør udvides derpå i en form, f.eks. som vist i fig.
35 1 på tegningen. Som vist her kan den ene ende af røret fyldes med en væske under tryk under fremgangsmådens udvidelsestryk.
5 DK 169376 B1
Formen har en hulhed med dimensioner, der svarer til den størrelse ballon, der skal fremstilles. Den åbne ende af røret udstyres med et passende armatur, så at der kan indføres et fluidum under tryk i røret. Et hvilket som helst 5 egnet fluidum kan anvendes til dannelse af tryk til oppustning af det strakte rør, f.eks. en gas såsom nitrogen. Hvis røret strækker sig ud over formen, som vist i fig. 1, foretrækkes det at anvende begrænsende midler for at opretholde rørets dimensioner i afsnittet uden for formen, medens der 10 påføres tryk på rørets indervæg. Begrænsningsmidlerne kan være af et hvilket som helst materiale, der ikke er deformerbart ved rørets udvidelsesbetingelser. Efter at det strakte rør er anbragt i formen, påføres der varme for at hæve rørets temperatur. Der kan anvendes samme temperaturer til både 15 stræknings- og udvidelsestrinnet. En passende temperatur ligger i intervallet, der går fra overgangstemperaturen af anden orden til overgangstemperaturen af første orden for den polymer, hvoraf røret er blevet fremstillet. For PET-homopolymeren, der her anvendes som eksempel, ligger den 20 foretrukne temperatur på 84-89”C, især 86-89”C. Da ballonen skal anvendes ved lægelige procedurer, der indebærer berøring med væv, skal det polymere fremstillingsmateriale være vævsforligeligt.
Det er afgørende for opfindelsen, at grænseviskosi-25 tetstallet, et mål for polymerens molekylvægt, er højt.
særlige, men kendte metoder anvendes til at forøge molekylvægten til det nødvendige niveau. Den PET-homopolyester, der er lettest at skaffe, har i reglen et grænseviskositetstal på ca. 0,5-0,6, godt under det nødvendige 1,0-1,3.
30 En vis justering af stræknings- og ekspansionsforhol dene og stræknings- og ekspansionstemperaturerne samt grænseviskositetstallet (molekylvægt) og massefylde, kan være nødvendig for at lempe sig efter forskellen med hensyn til grundlæggende fysiske egenskaber mellem PET-homopolyesteren, 35 der er anvendt som eksempel heri, og PET-copolyestere, der kan anvendes til fremstilling af ballonen. Selv om rørets DK 169376 B1 6 strækningstrin udføres før ekspansionstrinnet, kan sidstnævnte udføres umiddelbart efter strækning af røret, eller det kan udføres på et senere tidspunkt. Selv om strækningen af røret kan udføres ved hjælp af et hvilket som helst stræk-5 ningsapparatur, kan det dog bedst ske i et apparat som afbildet i fig. 1, så at det strakte rør allerede er på plads, når ekspansionen skal udføres. På grund af restitutionsegenskaberne hos de formede polymerstrukturer, der strækkes ved de her anvendte metoder, kan det være nødvendigt at oprethol-10 de aksial spænding på det strakte rør under udvidelsestrin net. Stræknings- og udvidelsestrinnet kan udføres ved ens eller forskellige temperaturer. Den ønskede temperatur kan opnås ved hjælp af en hvilken som helst egnet opvarmning. I eksperimenter, der er udført her med hensyn til anvendelsen 15 af PET-homopolyester, blev der anvendt varmt vand. Strækning af røret i det foreliggende eksempel opnås ved hjælp af formens vægt.
Et udvidelsesballonkateter, der omfatter en ballon ifølge opfindelsen, kan fremstilles ved hjælp af gængs tek-20 nik, og et sådant kateter kan anvendes i overensstemmelse med anerkendte medicinske procedurer.
Nedenstående er en beskrivelse af et repræsentativt eksempel på fremgangsmåden ifølge opfindelsen. Henvisninger til fig. li dette eksempel sker af hensyn til en beskrivelse 25 af cylinderdimensionerne A, B, C og D, eftersom dette eksempels udførelsesform kun delvis er afspejlet i figuren, hvilket vil fremgå af beskrivelsen. Et rør (1,5 mm OD x 0,75 mm ID) indføres i en form med en hulhed udformet som en cylinder, i lighed med den , der er vist i fig. 1, med ender, 30 der spidser til mod cylindre med mindre diametre på lidt over rørets OD. Hulhedens diameter D er ca. 5 mm og den længde A + B + C ca. 15 mm. Røret klemmes af ved formens nederste ende, og der fastgøres vægte på formen for at give det nødvendige aksiale træk (ca. 3 x) . Formens og væg-35 tenes samlede vægt er ca. 150 g. Vægten af det hele (form, rør og vægte) bæres af røret, der i sin øverste ende er 7 DK 169376 B1 fastgjort ved indføring i et rørarmatur. Alle delene indføres i et væskemedium ved 87'C og får lov at varme op i ca. 1 minut. I dette tidsrum sker der aksial orientering, fordi delenes vægt i den opvarmede væske bæres af i røret. Der 5 påføres et gastryk på 1,4 MPa på røret, hvilket orienterer røret radialt (ca. 3,33 x) i formens hulhed. Trykudøvelsestrinnet varer ca. 2 minutter, hvorunder der forekommer et vist yderligere aksialt træk. Det hele afkøles ved ned-dypning i en kold væske, trykket ophæves, og den færdige 10 ballon fjernes fra formen.
Fremgangsmåden i dette eksempel anvendes til fremstilling af balloner med vægtykkelser på ca. 0,028-0,045 mm og bristningsstyrker på 3,3-3,6 MPa som vist i fig. 2. Når sådanne balloner svigter (ved bristning), fremkommer der et 15 ellipseformet hul, hvis største akse går i det væsentlige langs den aksiale retning.
Ved en anden fremstillingsmetode, der er mere egnet til massefremstilling, anvendes en stationær form med indvendige strømningskanaler til varme og kolde væsker. Røret 20 bliver aksialt orienteret efter forud bestemte forhold ved hjælp af en trinmotor frem for med en fastgjort vægt. Under den radiale udvidelsesfase kan yderligere aksial strækning være nødvendig.
25 30 35
Claims (7)
1. Kateterballon af fleksibel polymer, kendetegnet ved, at polymeren er en højmolekylær, biaksialt orienteret polyethylenterephthalat-homo- eller -copolyester 5 med et grænseviskositetstal på 0,8-1,1, bestemt ifølge ANSI/-ASTM D 2857-70.
2. Kateterballon ifølge krav 1, kendetegnet ved, at den har en vægtykkelse på 0,028 til 0,045 mm.
3. Fremgangsmåde til fremstilling af en kateterballon 10 ifølge krav 1, hvorved et rør af polyethylenterephthalat- -homo- eller copolyesteren opvarmes og strækkes i længderetningen, og det opvarmede rør udvides radialt, kendetegnet ved, at et polymerrør med en endelig længde (L^) og en indvendig diameter (ID), der fortrinsvis er ca. 15 halvdelen af den udvendige diameter (OD), ved en temperatur i intervallet fra overgangstemperaturen af anden orden til overgangstemperaturen af første orden strækkes til en længde (L2), der er 3-6 Llf og at det strakte rør med en indvendig diameter ID^ og en udvendig diameter OD^ ved hjælp af gas 20 eller væske under tryk derefter udvides til en indvendig diameter (ID2), som er 6-8 ID, og en udvendig diameter (OD2), der fortrinsvis er 3-4 OD, efterfulgt af afkøling af det strakte og udvidede rør til under dets overgangstemperatur af anden orden.
4. Fremgangsmåde ifølge krav 3, kendeteg net ved, at røret dannes ved ekstrusion af polyethylen-terephthalat-homopolyesterharpiks med et grænseviskositetstal på 1,0-1,3 og en massefylde på 1,35-1,45 g/ciP.
5. Fremgangsmåde ifølge krav 4, kendeteg-30 net ved, at temperaturen ligger i intervallet 84-99eC, fortrinsvis 86-96°C.
6. Fremgangsmåde ifølge krav 4, kendetegnet ved, at rørets strækningstemperatur afviger fra dets udvidelsestemperatur.
7. Udvidelsesballonkateter, kendetegnet ved, at det omfatter en kateterballon ifølge et af kravene 1-4.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US06/510,812 US4490421A (en) | 1983-07-05 | 1983-07-05 | Balloon and manufacture thereof |
US51081283 | 1983-07-05 |
Publications (3)
Publication Number | Publication Date |
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DK328384D0 DK328384D0 (da) | 1984-07-04 |
DK328384A DK328384A (da) | 1985-01-06 |
DK169376B1 true DK169376B1 (da) | 1994-10-17 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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DK328384A DK169376B1 (da) | 1983-07-05 | 1984-07-04 | Kateterballon, fremgangsmåde til fremstilling heraf, og udvidelsesballonkateter omfattende en sådan kateterballon |
Country Status (9)
Country | Link |
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US (1) | US4490421A (da) |
EP (2) | EP0135990B1 (da) |
JP (3) | JPS6034452A (da) |
AT (2) | ATE56885T1 (da) |
CA (1) | CA1257171A (da) |
DE (2) | DE3486414T2 (da) |
DK (1) | DK169376B1 (da) |
ES (1) | ES8605713A1 (da) |
GR (1) | GR82175B (da) |
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-
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- 1983-07-05 US US06/510,812 patent/US4490421A/en not_active Ceased
-
1984
- 1984-07-02 JP JP59135372A patent/JPS6034452A/ja active Granted
- 1984-07-04 DE DE3486414T patent/DE3486414T2/de not_active Expired - Lifetime
- 1984-07-04 EP EP84304570A patent/EP0135990B1/en not_active Expired - Lifetime
- 1984-07-04 AT AT84304570T patent/ATE56885T1/de not_active IP Right Cessation
- 1984-07-04 AT AT89202699T patent/ATE130772T1/de not_active IP Right Cessation
- 1984-07-04 DK DK328384A patent/DK169376B1/da not_active IP Right Cessation
- 1984-07-04 ES ES534024A patent/ES8605713A1/es not_active Expired
- 1984-07-04 DE DE8484304570T patent/DE3483295D1/de not_active Expired - Lifetime
- 1984-07-04 EP EP89202699A patent/EP0355937B1/en not_active Expired - Lifetime
- 1984-07-04 GR GR75200A patent/GR82175B/el unknown
- 1984-07-05 CA CA000458246A patent/CA1257171A/en not_active Expired
- 1984-09-10 JP JP59188265A patent/JPS60185565A/ja active Granted
-
1987
- 1987-10-21 JP JP62264044A patent/JPS63192456A/ja active Granted
Also Published As
Publication number | Publication date |
---|---|
EP0355937A2 (en) | 1990-02-28 |
JPH0363908B2 (da) | 1991-10-03 |
CA1257171A (en) | 1989-07-11 |
EP0135990B1 (en) | 1990-09-26 |
ES534024A0 (es) | 1986-04-01 |
US4490421A (en) | 1984-12-25 |
DE3486414T2 (de) | 1996-06-05 |
JPS6034452A (ja) | 1985-02-22 |
JPS63192456A (ja) | 1988-08-09 |
DE3483295D1 (de) | 1990-10-31 |
DK328384A (da) | 1985-01-06 |
JPS6326655B2 (da) | 1988-05-31 |
GR82175B (da) | 1984-12-13 |
DK328384D0 (da) | 1984-07-04 |
EP0355937A3 (en) | 1990-04-11 |
EP0355937B1 (en) | 1995-11-29 |
ATE56885T1 (de) | 1990-10-15 |
EP0135990A1 (en) | 1985-04-03 |
JPS60185565A (ja) | 1985-09-21 |
JPH0228341B2 (da) | 1990-06-22 |
ATE130772T1 (de) | 1995-12-15 |
ES8605713A1 (es) | 1986-04-01 |
DE3486414D1 (de) | 1996-01-11 |
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