ES2260610T3 - Implante de titanio que sirve para reemplazar una articulacion del cuerpo comprendiendo uno o varios cuerpos de base. - Google Patents

Implante de titanio que sirve para reemplazar una articulacion del cuerpo comprendiendo uno o varios cuerpos de base.

Info

Publication number
ES2260610T3
ES2260610T3 ES03708087T ES03708087T ES2260610T3 ES 2260610 T3 ES2260610 T3 ES 2260610T3 ES 03708087 T ES03708087 T ES 03708087T ES 03708087 T ES03708087 T ES 03708087T ES 2260610 T3 ES2260610 T3 ES 2260610T3
Authority
ES
Spain
Prior art keywords
implant
titanium
bone
base bodies
implant according
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.)
Expired - Lifetime
Application number
ES03708087T
Other languages
English (en)
Inventor
Hans-Georg Neumann
Peter Zeggel
Giles Melsom
Egidius Hermsen
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.)
DOT GmbH
Diocom BV
Original Assignee
DOT GmbH
Diocom BV
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 DOT GmbH, Diocom BV filed Critical DOT GmbH
Application granted granted Critical
Publication of ES2260610T3 publication Critical patent/ES2260610T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/30Inorganic materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/42Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4241Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for hands, e.g. fingers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02Inorganic materials
    • A61L27/04Metals or alloys
    • A61L27/06Titanium or titanium alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/30Inorganic materials
    • A61L27/306Other specific inorganic materials not covered by A61L27/303 - A61L27/32
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    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/30Inorganic materials
    • A61L27/32Phosphorus-containing materials, e.g. apatite
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
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    • A61F2/36Femoral heads ; Femoral endoprostheses
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3662Femoral shafts
    • A61F2/367Proximal or metaphyseal parts of shafts
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3662Femoral shafts
    • A61F2/3676Distal or diaphyseal parts of shafts
    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/38Joints for elbows or knees
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30016Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in hardness, e.g. Vickers, Shore, Brinell
    • AHUMAN NECESSITIES
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30028Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
    • AHUMAN NECESSITIES
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    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30062(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • A61F2002/30064Coating or prosthesis-covering structure made of biodegradable material
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    • A61F2002/30317The prosthesis having different structural features at different locations within the same prosthesis
    • A61F2002/30322The prosthesis having different structural features at different locations within the same prosthesis differing in surface structures
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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Abstract

Implante de titanio que sustituye a una articulación del cuerpo, con uno o varios cuerpos de base (1, 5, 6) que se fijan en el hueso, caracterizado porque una parte del implante (3, 8, 9) presenta una capa oxidada anódicamente (tipo II) que contiene oxígeno y silicio.

Description

Implante de titanio que sirve para reemplazar una articulación del cuerpo comprendiendo uno o varios cuerpos de base.
La invención está relacionada con un implante de titanio que posee uno o varios cuerpos de base que quedan anclados en el hueso.
En el campo de la ortopedia se emplean titanio o aleaciones de titanio como o material para la producción de implantes dado que, por una parte, son mas ligeras que las aleaciones de acero y, por otra parte, resultan biocompatibles. Esto permite que el implante se adhiera, por ejemplo a las células óseas.
Sin embargo, en el caso de algunos implantes es deseable que la adherencia sea solamente parcial. Para lograr, por ejemplo, una buena adherencia de un implante de cadera no cementado es preciso estimular por su parte proximal el crecimiento de las células óseas a fin de conseguir una buena unión entre el hueso y el implante. Dado que la neoformación del hueso resulta más fuerte en el punto en el que existe una carga fisiológica óptima existe el riesgo de que la zona de neoformación del hueso se desplace hacia la zona distal del implante, tal como nos enseña la ley de Wolff. En esta zona el crecimiento del hueso se estimula de forma especialmente intensa y el implante se une más fuerte al hueso. Existe, por lo tanto, el riesgo de que en la zona proximal se produzca una osteólisis y que el implante se afloje. En el peor de los casos, esta circunstancia da lugar a la rotura del implante. Con objeto de evitar el riesgo de aflojamiento del implante, los implantes de cadera presentan en parte una zona proximal configurada de manera especial y dotada de una superficie rugosa y/o de un recubrimiento de fosfatos cálcicos con lo que se pretende fomentar el crecimiento del hueso y conseguir un buen anclaje del hueso. No obstante, estas medidas no pueden evitar la neoformación del hueso y, por consiguiente, el anclaje del implante en la zona distal. Para contrarrestar el aflojamiento del implante en la zona proximal existen implantes que poseen en la zona distal superficies pulidas. Una superficie pulida retrasa ciertamente la generación de células óseas en la superficie metálica pero no puede impedir el anclaje fijo en el hueso.
El objetivo de la presente invención consiste en configurar la superficie de la zona de un implante de titanio, en el que no se desea una adherencia a l tejido óseo o a las células óseas, de manera que se impida la neoformación de células óseas en la superficie metálica.
De acuerdo con la invención, este objetivo se consigue porque una parte del implante de titanio presenta una capa obtenida por oxidación anódica del tipo II que contiene oxígeno y silicio.
El procedimiento de la oxidación anódica del tipo II se describe en el documento AMS 2488 editado por SAE International, Warrendale, EE.UU. 1994. En la oxidación anódica del tipo II no se forma ninguna capa de TiO_{2} sino que más bien se trata de incorporar oxígeno y silicio en la capa cercana a la superficie, definida como capa de conversión, que forman parte integrante del material. Esta capa obstaculiza, por una parte, la adherencia de células óseas consiguiéndose, por otra parte y gracias a la misma, una mayor resistencia del material de titanio. Esto significa para un implante de cadera que en la zona oxidada anódicamente (tipo II) no se produce ningún anclaje fijo del implante en el hueso. La zona de carga necesaria para la generación del hueso se limita, por lo tanto, a la zona proximal del implante. De este modo se evita un aflojamiento del implante. Si a largo plazo se produjera, a pesar de todo, una adhesión en la zona distal se reduce, gracias a la mayor resistencia a la carga de rotura , el riesgo de rotura del implante. Lo anteriormente expuesto se puede aplicar igualmente a los implantes de rodilla.
En los implantes de titanio con elementos de enclavamiento móviles el recubrimiento del elemento obstaculiza la adherencia al tejido conjuntivo. Otra de las ventajas consiste en la mejora de la capacidad de deslizamiento del elemento de enclavamiento dado que el recubrimiento evita una soldadura en frío de las dos partes del elemento de enclavamiento.
En las reivindicaciones dependientes se describen otras configuraciones ventajosas del implante según la invención.
A continuación se describen con mayor detalle algunos ejemplos de la invención por medio de los dibujos.
Se ve en la:
Figura 1 una representación esquemática de un implante de cadera y en la
Figura 2 una representación esquemática de un implante de dedo.
El implante de cadera de la figura 1 consta de un cuerpo de base 1 que en su parte proximal presenta una zona 2 que ha de anclarse firmemente en el hueso. Esta zona posee preferiblemente una superficie rugosa que se puede obtener aplicando chorros de arena de granulado grueso o un recubrimiento de titanio. A fin de estimular el crecimiento del hueso resulta conveniente que la superficie rugosa se recubra de una o varias capas de fosfato cálcico que pueden ser resorbidas. A esta zona sigue, en la parte distal del implante, una zona 3 que no debe adherirse al hueso y que, por este motivo, se oxida anódicamente (tipo II). Durante esta modificación de la superficie se incorporan a la superficie de titanio oxígeno y silicio formando allí una parte integrante de la capa de conversión. La zona no presenta ninguna capa de TiO_{2}. Si se desea, también se pueden incorporar a la capa de conversión carbono y nitrógeno.
La capa de conversión obstaculiza, por una parte, la adhesión de células óseas. Por otra parte, conduce también a una mayor dureza y, por consiguiente, a una mayor resistencia a la carga de rotura de esta parte rediciendo además la corrosión por fricción.
El implante de cadera posee igualmente un cono 4 para una cabeza de enclavamiento. Puesto que en las intervenciones quirúrgicas de revisión se desea que el cuerpo de base del implante de cadera permanezca en el hueso es conveniente proceder también a la oxidación anódica del tipo II del cono 4. Así la cabeza de enclavamiento se puede retirar con mayor facilidad del cuerpo de base. La mayor dureza proporciona además una protección contra el deterioro del
cono.
En la figura 2 se representa un implante de una articulación falángica compuesto por los cuerpos de base 5 y 6 que han de adherirse a las correspondientes falanges. Estos cuerpos tienen una superficie rugosa y están dotados ventajosamente de una o varias capas de fosfato cálcico resorbibles. A través de una pieza articulada 7 los dos cuerpos de base 5 y 6 se unen a los conos 8 y 9 que se introducen en los casquillos de anclaje 10, 11 situados en los cuerpos de base 5 y 6. Con objeto de facilitar el movimiento de los conos 8 y 9 en los casquillos 10, 11 es preciso que la disposición sea móvil. La movilidad también debe quedar garantizada después de la colocación del implante de articulación falángica y en todo caso hay que evitar que la adhesión al tejido conjuntivo la obstaculice. Por este motivo se dota a los conos 8 y 9 así como a los casquillos de anclaje 10, 11 de una capa de óxido anódico del tipo II. Además de impedir la adherencia de tejido conjuntivo, el recubrimiento ofrece la ventaja de que se evita una soldadura en frío de los conos y casquillos de anclaje y de que se obtienen buenas superficies de deslizamiento.

Claims (10)

1. Implante de titanio que sustituye a una articulación del cuerpo, con uno o varios cuerpos de base (1, 5, 6) que se fijan en el hueso, caracterizado porque una parte del implante (3, 8, 9) presenta una capa oxidada anódicamente (tipo II) que contiene oxígeno y silicio.
2. Implante de titanio según la reivindicación 1, caracterizado porque la capa contiene además carbono y/o nitrógeno.
3. Implante de titanio según la reivindicación 1 ó 2, caracterizado porque la parte no recubierta que se une al hueso (2, 5, 6) posee una superficie rugosa.
4. Implante de titanio según la reivindicación 3, caracterizado porque la superficie rugosa se recubre de fosfatos cálcicos resorbibles.
5. Implante de titanio según la reivindicación 4, caracterizado porque la capa de fosfato cálcico está formada por varias capas.
6. Implante de titanio según cualquiera de las reivindicaciones 1 a 5, caracterizado porque se trata de un implante de cadera.
7. Implante de titanio según la reivindicación 7, caracterizado porque el cono (4) para una cabeza de enclavamiento presenta igualmente una capa oxidada anódicamente (tipo II).
8. Implante de titanio según cualquiera de las reivindicaciones 1 a 5, caracterizado porque en el caso del implante se trata de un implante de rodilla.
9. Implante según cualquiera de las reivindicaciones 1 a 5, caracterizado porque en el caso del implante se trata de una articulación falángica compuesta por dos cuerpos de base unidos entre sí a través de una articulación, presentando la articulación una capa oxidada anódicamente (tipo II).
10. Implante según la reivindicación 9, caracterizado porque el implante del dedo se compone de los cuerpos de base (5, 6) y de una parte articulada (7) separada de los mismos presentando los conos (8, 9) de la parte articulada (7) y los casquillos de anclaje de los cuerpos de base (5, 6) capas oxidadas anódicamente (tipo II).
ES03708087T 2002-02-15 2003-02-10 Implante de titanio que sirve para reemplazar una articulacion del cuerpo comprendiendo uno o varios cuerpos de base. Expired - Lifetime ES2260610T3 (es)

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DE10206627A DE10206627A1 (de) 2002-02-15 2002-02-15 Körpergelenk ersetzendes Titanimplantat mit einem oder mehreren Grundkörpern
DE10206627 2002-02-15

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CA (1) CA2475168C (es)
DE (2) DE10206627A1 (es)
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JP2005525152A (ja) 2005-08-25
DE50303189D1 (de) 2006-06-08
CN1633312A (zh) 2005-06-29
WO2003068286A1 (de) 2003-08-21
ATE324916T1 (de) 2006-06-15
US20050119760A1 (en) 2005-06-02
CA2475168A1 (en) 2003-08-21
DE10206627A1 (de) 2003-08-28
AU2003212236A1 (en) 2003-09-04
AU2003212236B2 (en) 2007-05-24
EP1474185A1 (de) 2004-11-10
CN1273200C (zh) 2006-09-06
DK1474185T3 (da) 2006-07-03
PT1474185E (pt) 2006-08-31
CA2475168C (en) 2011-08-16
EP1474185B1 (de) 2006-05-03

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