ES2310255T3 - Implante de disco intervertebral. - Google Patents

Implante de disco intervertebral. Download PDF

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Publication number
ES2310255T3
ES2310255T3 ES03788497T ES03788497T ES2310255T3 ES 2310255 T3 ES2310255 T3 ES 2310255T3 ES 03788497 T ES03788497 T ES 03788497T ES 03788497 T ES03788497 T ES 03788497T ES 2310255 T3 ES2310255 T3 ES 2310255T3
Authority
ES
Spain
Prior art keywords
intervertebral disc
disc
end plates
membrane
disk
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
ES03788497T
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English (en)
Inventor
Justin K. Coppes
David Gerber
David Paul
Andrew Lee
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.)
Synthes GmbH
Original Assignee
Synthes GmbH
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 Synthes GmbH filed Critical Synthes GmbH
Application granted granted Critical
Publication of ES2310255T3 publication Critical patent/ES2310255T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • 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
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • 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
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/441Joints for the spine, e.g. vertebrae, spinal discs made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
    • 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
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • A61F2/4425Intervertebral or spinal discs, e.g. resilient made of articulated components
    • 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
    • A61F2/08Muscles; Tendons; Ligaments
    • 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
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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
    • A61F2/30721Accessories
    • A61F2/30742Bellows or hose-like seals; Sealing membranes
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    • A61F2/3094Designing or manufacturing processes
    • A61F2/30965Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
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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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    • A61F2/4455Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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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
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • A61F2002/2835Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
    • 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
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    • 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
    • A61F2002/30014Material 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 elasticity, stiffness or compressibility
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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Prostheses (AREA)
  • Polishing Bodies And Polishing Tools (AREA)
  • Magnetic Treatment Devices (AREA)
  • Electrochromic Elements, Electrophoresis, Or Variable Reflection Or Absorption Elements (AREA)

Abstract

Un disco intervertebral (10) para su ubicación entre la primera y segunda vértebra incluye: una placa terminal superior (12) con una primera superficie interna y una primera superficie externa, la primera superficie externa contacta a la primera vértebra; una placa terminal inferior (14) que tiene segunda superficie interna y una segunda superficie externa, la segunda superficie externa contacta a la segunda vértebra, una membrana (16) que se extiende desde la placa terminal superior (12) y la placa terminal inferior (14), un volumen interior (19) definido entre las placas terminales (12, 14) y la membrana elástica (16), una válvula (20) en comunicación con el volumen interior (19) llenando por lo menos parcialmente el volumen con un fluido (22), en donde una de las primeras y segundas superficies internas tiene un alvéolo (32) y la otra de la primera y segunda superficies interna tienen una protrusión (34), en donde la protrusión (34) se configura de manera convexa para articular dentro del alvéolo cóncavo (32), caracterizado porque el alvéolo (32) y la protrusión (34) están configurados y poseen las dimensiones para acoplarse o para que generalmente encastren entre si, y la membrana elástica (16) está configurada alrededor del alvéolo (32) y la protrusión (34), permitiendo flexión, extensión, curvatura lateral, rotación y traslación, en donde la traslación es un movimiento generalmente transverso al eje de la columna vertebral por lo que permite movimiento instantáneo de rotación del eje.

Description

Implante de disco intervertebral.
Campo de la invención
La presente invención se refiere a los dispositivos y métodos para el tratamiento de los traumatismos y enfermedades de la columna vertebral. Especialmente, a la invención referida al cambio de los discos intervertebrales.
Antecedentes de la invención
Una gran variedad de condiciones como la espondilólisis, hernia de disco, compresión de los nervios espinales, enfermedad degenerativa de disco, y traumatismo son conocidos por causar malestar severo que requiere de atención médica. Entre los procedimientos por lo general utilizados para aliviar dichas condiciones se encuentra la fusión espinal, como la intervertebral y la fusión posterolateral o artródesis. En estos procedimientos, se fusionan juntos dos cuerpos vertebrales adyacentes. Primero se extirpa el disco intervertebral afectado, y se inserta un implante que acomoda el crecimiento del hueso entre los dos cuerpos vertebrales para unir de manera efectiva la brecha creada por la remoción del disco. Se han utilizado diferentes materiales o diseños de implantes para la fusión resultando en diferentes grados de éxito. Aunque la fusión intervertebral y la posterolateral son ampliamente utilizadas, las desventajas que se pueden observar incluyen un rango reducido de movilidad fisiológica y otras complicaciones relacionadas a la fusión como la degeneración de los discos adyacentes y desestabilización de la unidad funcional espinal. Como resultado, se prefieren tratamientos alternativos que presentan menores complicaciones pero que tienen una eficacia similar para la fusión. Una de esas alternativas para la fusión espinal es la artroplastia y el uso de disco prostésico o artificial.
Por lo general, la artroplastia se utiliza para el reemplazo de las articulaciones enfermas. La artroplastia incluye un conjunto de procedimientos destinados a mantener la movilidad de la articulación, es decir, preserva su integridad y evita el deterioro de los segmentos adyacentes, como suele suceder luego de la fusión. Dependiendo de la ubicación y de la condición de la articulación afectada, se pueden utilizar procedimientos específicos de artroplastia. Por ejemplo, cirugía de reconstrucción interposicional, la cual reforma la articulación y agrega un disco protésico entre los dos huesos formando la articulación y se utiliza por lo general en las articulaciones del codo, hombro, tobillo y dedos. El reemplazo total de la articulación, o la artroplastia total, reemplaza a la totalidad de la articulación enferma por una prótesis artificial y, en los últimos años se ha convertido en la operación preferida para la mayoría de los problemas de rodilla y cadera.
Los reemplazos de cadera y rodilla se han extendido hasta alcanzar aproximadamente 300.000 reemplazos de cadera casi igualando la cantidad de reemplazos de rodilla realizados en los Estados Unidos durante el año 2001. Con respecto a las cirugías de reemplazo de articulación de rodilla y cadera, existen varios implantes o protésicos disponibles. Para el protésico de cadera, de manera ejemplificadora, hay dos componentes, uno es una bola metálica adjunta a un tallo metálico que se coloca dentro del fémur, y el segundo es un alvéolo plástico que se implanta en la pelvis. Las piezas metálicas por lo general se encuentran formadas acero inoxidable, aleaciones de cobalto y cromo, titanio, y aleaciones de titanio, las piezas plásticas por lo general están formadas por polietileno de alta densidad. Para el protésico de rodilla, en una incorporación ejemplificadora, se utilizan nuevamente componentes de metal y plástico para reemplazar las extremidades dañadas del hueso y el cartílago. Las piezas metálicas por lo general se forman de acero inoxidable, aleaciones de cobalto y cromo, titanio, y aleaciones de titanio; las piezas plásticas por lo general están formadas de polietileno de alta densidad. Para los protésicos de rodilla, en una incorporación ejemplificadora, se utilizan también componentes metálicos y plásticos para el reemplazo de las extremidades del hueso dañado y del cartílago. Las piezas metálicas por lo general se encuentran formadas por acero inoxidable, aleaciones de cobalto y cromo, titanio, y aleaciones de titanio, las piezas plásticas se encuentran formadas por polietileno de alta densidad.
Aunque la evolución de la artroplastia espinal y el uso de los protésicos en la médula ha sido similar a la evolución de las otras articulaciones del cuerpo, la evolución de la fusión de la articulación al reemplazo de la articulación funcional, el surgimiento de la artroplastia espinal, ha sido más lento que la artroplastia en otras articulaciones mayores del cuerpo. Algunas de las pocas razones posibles por las cuales la artroplastia espinal se desarrolló más lentamente son que los problemas espinales relacionados a la degeneración del disco son difíciles de diagnosticar, los procedimientos espinales son típicamente llevados a cabo luego de una crisis y como consecuencias se aceptan soluciones conservadoras como la fusión, y la anatomía espinal es compleja.
Durante los últimos 40 años, la tecnología sobre artroplastia espinal ha estado en desarrollo y en los últimos 10 años, la artroplastia espinal ha ganado la atención de los principales cirujanos y fabricantes de implantes. La evolución de la artroplastia comenzó básicamente en la década de 1950 y uno de los variados conceptos emergentes fue el concepto esférico de las prótesis de disco. El concepto esférico se refiere simplemente la colocación de la bola, en esencia una circunferencia, en la cavidad del núcleo pulposo luego de realizar el procedimiento de disectomia. El annulus se mantiene en su lugar y la bola sirve como dispositivo núcleo de reemplazo. Se han experimentado materiales diversos para el concepto esférico. Por ejemplo, en la década de 1960, se colocaron implantes con soporte para las bolas de silicona en la región cervical de los pacientes, pero los resultados eran inciertos. A mediados de la década de 1960 se implantaron prótesis de acero inoxidable (soportes de bola) en los pacientes. Los resultados de los procedimientos fueron al comienzo alentadores pero con el transcurso del tiempo los espacios de los discos perdieron altura debido al hundimiento de las bolas de acero dentro de los cuerpos vertebrales. En la actualidad, el concepto de las prótesis esféricas continúa siendo estudiado utilizando diferentes materiales, el último de ellos es fibra de carbón modificado.
Otro concepto emergente es el de diseño mecánico. El concepto de diseño mecánico es esencialmente el del reemplazo total del disco con el fin de reparar la movilidad del segmento vertebral. Estos dispositivos por lo general están hechos de placas terminales fijas a los cuerpos vertebrales adyacentes mediante el mecanismo de estabilización y su núcleo está formado de polietileno u otros materiales poliméricos. Alternativamente, en lugar de un núcleo, se pueden utilizar superficies de soporte con materiales tales como cerámica sobre cerámica, metal sobre metal, o metal sobre polietileno. El concepto de diseño mecánico se basa en los mismos principios de los productos de reconstrucción de articulación, como los reemplazos de rodilla y cadera, y se han propuesto y aún se siguen proponiendo varios conceptos de prótesis mecánicas.
Otro concepto es el fisiológico. El concepto fisiológico utiliza un hidrogel, elastómero, o un núcleo de poliuretano que se utiliza para restaurar la función del disco mediante la absorción y la emisión de fluido entre las placas terminales del paciente, mientras que también mantiene el shock natural de las funciones de absorción y de efecto amortiguador del disco. El concepto fisiológico de los dispositivos es por lo general considerado sólo una solución parcial ya que estos son diseñados para reemplazar sólo el núcleo o una porción del disco.
Todos los enfoques destinados al reemplazo del disco tienen como objetivo algunos o todos de los siguientes: alivio del dolor discogénico, restauración de la movilidad, la mantención de la función natural de shock de absorción del disco, restauración de la forma normal o altura del disco, y la restauración de la cinemática fisiológica. Por lo general, se han desarrollado ejemplos de discos artificiales intervertebrales para el reemplazo de una parte o de todo el disco extirpado: elastómero/llenado de fluido, discos, bola y alvéolos de discos tipo, resorte de disco mecánico y discos híbridos.
Elastómero/discos llenos de fluido típicamente incluyen un amortiguador de elastómero o una cámara llena de fluido ubicada entre las placas terminales rígidas inferiores y superiores. Los amortiguadores y cámaras de estos implantes funcionan de manera ventajosa y mecánica, similar a un tejido de disco intervertebral removido.
Los discos de tipo bola o alvéolos típicamente incorporan dos placas miembro que tienen una bola de cooperación interna y porciones de alvéolos que permiten el movimiento articulatorio de los miembros durante los movimientos de la columna.
Los resortes mecánicos típicamente incorporan uno o más resortes graduables dispuestos entre placas terminales de metal. Los resortes graduables definen un resorte acumulativo constante que se diseña para que sea suficiente para mantener la distribución del espacio de la vértebra adyacente mientras permite el movimiento normal de las vértebras durante la flexión y extensión de la espina en cualquier dirección.
El cuarto tipo de disco intervertebral artificial, el disco híbrido, incorpora dos o más de los principios de diseño antes mencionado. Por ejemplo, una de las distribuciones conocidas de los discos híbridos incluye la bola y el alvéolo de la articulación rodeada de un anillo de elastómero.
Mientras que cada una de las presentes prótesis hace referencia a algunos de los problemas relacionados al reemplazo de disco intervertebral, cada implante presenta desventajas significativas. Por eso, existe la necesidad de un implante intervertebral que acomode la anatomía y la geometría del espacio intervertebral que se busca rellenar tan bien como la anatomía y geometría de los extremos de los cuerpos vertebrales adyacentes, y que además cuente con confiabilidad y simplicidad en el diseño. En especial, existe la necesidad de un implante de disco espinal que provea estabilidad para soportar las grandes cargas aplicadas a las vértebras, que permita suficiente movilidad para que el paciente puede aproximarse a un rango de movilidad normal, y que brinde compresión axial entre las vértebras adyacentes, como así también que cuente con habilidades de shock de absorción.
El documento FRA-A1-2723841, Gauchet Fabien, da a conocer un disco intervertebral para la ubicación entre la primera y segunda vértebra que comprende placas terminales y una membrana que se extiende entre las placas terminales y el volumen interior definido entre las placas terminales y la membrana elástica. Un movimiento horizontal de translación no es posible debido a la bola 7 en el tallo 6, es limitado por una cámara cilíndrica 8 que lo rodea y que tiene como fin permitir el desplazamiento angular relativo y la variación de distancia entre las placas. No muestra alvéolos convexos o cóncavos ni protrusiones y tiene dimensiones que encajan o corresponden generalmente con cada flexión, extensión, curvatura lateral, rotación y translación por lo que permite un eje de rotación de movimiento instantáneo.
El documento US-B1-6375682, Fleischmann Lewis W, et al., da a conocer un disco intervertebral para ser ubicado entre la primera y segunda vértebra formando placas terminales y un fuelle que se extiende entre las placas terminales y un volumen interior definido entre las placas terminales y el fuelle elástico. Descubre una unión de soporte para la rotación del fuelle entre las placas terminales. Sin embargo, no se demuestra un alvéolo convexo o cóncavo y protrusión que tengan las dimensiones que correspondan por lo general entre si.
US-A-6113637, Gilí Stevans S, et al., da a conocer un disco intervertebral para la ubicación entre la primera y la segunda vértebra que forman la placa terminal. Las placas terminales superior e inferior poseen una protrusión o alvéolo que están directamente en contacto entre si. Sin embargo no demuestra una membrana que se extiende entre las placas terminales y que encierra un volumen interior definido entre las placas terminales.
US-B1-6419704, Ferree Bret, da a conocer un cuerpo con forma que tiene una medida de volumen final y que consume al menos una porción del espacio de disco intervertebral. El exterior del cuerpo del espacio intervertebral se encuentra recubierto por una pieza flexible de material 420 adjunto a las vértebras adyacentes o que retiene miembros 422. Sin embargo no da a conocer placas terminales superiores e inferiores ni alvéolos cóncavos o convexos y protrución que tenga las dimensiones que correspondan generalmente entre si.
US-A1-2002/045944, Muhanna Nabil, L, et al., da a conocer espaciadores de vértebra en cunea que tienen una superficie inferior y otra superior. Sin embargo, no da a conocer una membrana que se extiende entre las placas terminales que encierran a un volumen interior definido entre las placas terminales.
Síntesis de la invención
La invención se refiere a un disco intervertebral que es preferentemente diseñado para restaurar la altura del disco y lordosis, permite el movimiento natural, absorbe el shock y provee resistencia al movimiento y la compresión axial. Además, el disco intervertebral puede utilizarse en las regiones cervicales, torácicas, o lumbares de la columna.
El disco intervertebral incluye un cuerpo con una huella que preferentemente se adapta en medida y forma con al menos una porción de los extremos adyacentes de las vértebras. Las formas de los discos intervertebrales son, pero no están limitadas a, la forma circular, oval, elipsoide, en forma de alubia, anular, en forma de C, en forma de D, etc.
El cuerpo de los discos intervertebrales incluye una placa terminal superior, una placa terminal inferior, y una membrana elástica dispuesta entre las placas terminales superior e inferior. Alternativamente, la membrana elástica puede rodear y encapsular a las placas terminales. La membrana elástica define un interior que se encuentra al menos parcialmente lleno por un fluido. Preferentemente, el fluido se selecciona de un grupo que consiste en un gas, un liquido, un gel o cualquier combinación de los mismos. Además, el fluido puede ser compresible, y puede ser seleccionado de un grupo que consiste de, por ejemplo, gas, liquido, o hidrogel, o puede ser incompresible, y se puede seleccionar del grupo que consiste, por ejemplo, la solución salina.
El disco también incluye una válvula que permite la inserción del fluido al interior del disco intervertebral. La válvula puede ubicarse sobre una membrana elástica, alternativamente, sin embargo, la válvula puede ubicarse en las placas terminales superior o inferior del disco.
Las placas terminales superior e inferior son preferentemente de metal, como el titanio, acero inoxidable, aleaciones de titanio, aleaciones de cromo de cobalto, o aleaciones amorfas. Alternativamente, sin embargo, las placas terminales superior e inferior pueden estar formadas de cerámica, compuestos, polímeros, como el polieteretercetona (por ejemplo, PEEK), o un polietileno ultra liviano molecular (por ejemplo, ÜHMWPE), hueso, que incluye, cortical, hueso esponjoso, aloinjerto, autoinjerto, xenoinjerto, hueso desmineralizado o parcialmente desmineralizado, o cualquier otro material que sirva como soporte de peso. Los materiales elegidos para las placas terminales, en combinación con el fluido deseado, son preferentemente seleccionados para reducir el uso, y por consiguiente brindan una mayor vida a la articulación.
La superficie externa de las placas terminales superior e inferior puede ser sustancialmente plana, en forma de cuña, etc. Las superficies exteriores de las placas terminales superior e inferior pueden tener forma de cúpula con sus radios definidos entre los planos sagital y coronal y que generalmente coinciden con los extremos de la vértebra adyacente. La forma de cúpula permite que las placas terminales superior e inferior se adapten mejor a los extremos adyacentes de las vértebras para un mejor encastre in situ.
El disco intervertebral además preferentemente cuenta con la resistencia a la migración de estructuras provista por la superficie externa de al menos una o ambas de las placas terminales con el fin de impedir el movimiento, dislocación o expulsión de las placas terminales dentro y desde los extremos de las vértebras adyacentes. Las estructuras resistentes a la migración incluyen, pero no están limitadas a: separadores, clavos, dientes, placas, clavos desplazables, dientes desplazables, clavos flexibles, dientes flexibles, alternativamente, dientes con forma, placas insertables o expansibles, tornillos, ganchos, serraciones, en forma de costilla, y superficies texturadas.
Además, las placas terminales superior e inferior se encuentran recubiertas con un crecimiento óseo que induce o conduce sustancia para promover el crecimiento interno del hueso con el fin de asegurar de permanentemente el disco a las vértebras adyacentes. Alternativamente, las placas terminales superior e inferior pueden tener una superficie más rígida; una superficie porosa, capas en las placas terminales tratadas con láser; integrar un andamio osteoconductivo/osteoinductivo; o puede ser provisto o estar hecho de un material integral osteoconductivo y/o osteoinductivo para promover el crecimiento óseo. Las placas terminales pueden también incluir una membrana y/o barrera para limitar la cantidad y/o profundidad del crecimiento interno óseo.
Las placas terminales superior e inferior pueden contener un implante adjunto de instrumentación, y estructuras de guía y retención. Por ejemplo, las placas terminales pueden tener orificios, ranuras, hilos, o cola de milano para la implantación del implante y/o para la distracción de las vértebras adyacentes. Por ejemplo, el disco puede incluir una ranura formada de placas terminal superior y/o inferior, la ranura está configurada para recibir un inserción de instrumento de implante, o distraer, o ambos.
Las placas terminales superior e inferior incluyen superficies articuladas, lo que provee de mayor movilidad al disco intervertebral. Las superficies articuladas preferentemente incluyen una superficie lustrada o con un acabado similar al del diamante, acabado TiNi, etc., con el fin de reducir el uso, disminuir la generación de partículas, y lograr una mayor vida del disco.
El disco intervertebral puede implantarse en módulos, si es posible, o puede implantarse prearmado. Un enfoque quirúrgico anterior, anteriolateral, o lateral puede utilizarse para implantar el disco intervertebral. Además, dependiendo del disco intervertebral que se implante, se puede utilizar un método quirúrgico mínimamente invasivo o distracción simultánea e implante. Además dependiendo del disco intervertebral que se implante, se puede adjuntar un Ligamento Anterior Longitudinal al disco o a los cuerpos vertebrales adyacentes. El Ligamento Anterior Longitudinal puede estar formado por autoinjerto, aloinjerto, o xenoinjerto parcialmente desmineralizado o desmineralizado. Alternativamente, el Ligamento Anterior Longitudinal puede estar formado por materiales biocomplatibles como los elastómeros, o por polímeros trenzados. Con el fin de asistir al implante del disco intervertebral, éste debe incluir marcadores de alineación.
Descripción breve de los dibujos
Con el fin de facilitar la compresión y con el propósito de ilustrar la presente invención, se demuestran características ejemplificadoras y preferidas en los dibujos que siguen, cabe entender, sin embargo, que la invención no se encuentra limitada a los arreglos precisos e instrumentaciones mostradas, en donde caracteres similares de referencia denotan elementos similares mediante las distintas experiencias, y en donde:
La Figura 1 es una vista en perspectiva de un disco intervertebral.
La Figura 2 es una vista de sección cruzada del disco artificial intervertebral de la Figura 1 a lo largo de la línea A-A;
La Figura 2a es una vista de sección cruzada alternativa del disco artificial intervertebral de la Figura 1 a lo largo de la línea A-A;
La Figura 3a es una vista lateral de un clavo desplazable según la presente invención.
La Figura 3b es una vista lateral de otro clavo desplazable según la presente invención.
La Figura 3c es una vista lateral de un clavo flexible según la presente invención.
La Figura 3d es una vista lateral de un diente alternativamente modelado de acuerdo con la presente invención.
La Figura 3e es una vista lateral de soportes de acuerdo con la presente invención.
Descripción detallada sobre las formas de realización preferidas
Cualquiera de la amplia variedad de implantes diferentes pueden prepararse de acuerdo con las enseñanzas mostradas por los ejemplos ilustrativos de los discos intervertebrales que aquí se muestran. Los discos intervertebrales de la presente invención son preferentemente diseñados para restaurar la lordosis espinal, la altura de disco, para permitir movimientos naturales, absorber el shock y proveer resistencia al movimiento y a la compresión axial.
Los discos intervertebrales cuentan con el tamaño y la adaptación para el uso en las regiones cervical, tórax, y lumbar de la espina. Además, los discos intervertebrales pueden hacerse a la medida de cualquier paciente permitiendo por las características del disco adecuarse a cada paciente individual. Por ejemplo, el núcleo de disco puede incluir diferentes uniones, diferente componentes, y/o distintos tipos de materiales para crear las características deseadas para cada uno de los pacientes.
Además, los discos intervertebrales permiten flexión, extensión, movimiento lateral, rotación, y traslación. La flexión es un tipo de movimiento que hace que dos partes de la articulación o cuerpo se vuelvan en una posición curvada; en la espina, este es un movimiento en que ésta comienza en una posición recta y luego se vuelve en una posición curva hacia adelante. La extensión es un movimiento que hace que dos partes que se encontraban separadas entre si se junten, en la espina, este es un movimiento en el cual la espina comienza en una posición recta y luego se vuelve en una posición curva hacia atrás. La inclinación lateral es un movimiento en curva hacia un lateral; en la espina, este movimiento generalmente incluye la curvatura (lateral) y la rotación acoplada. La Rotación es un movimiento que hace que una parte de la espina se retuerza, rote o doble con respecto a un eje de la columna vertebral. La Traslación es un movimiento limitado que por lo general es transversal a un eje de la columna vertebral.
Además, similares a los discos intervertebrales naturales, los discos intervertebrales artificiales preferentemente permiten el movimiento instantáneo del eje de rotación. A cada instante de un cuerpo en un plano de movimiento existe una línea en el cuerpo o una extensión hipotética de esta línea que no se mueve. El eje instantáneo de rotación es esta línea. Un eje de movimiento instantáneo de rotación se refiere a la habilidad del eje instantáneo de rotación para moverse (por ejemplo, traslación), como un resultado de diferentes condiciones de carga, en otras palabras, la ubicación del eje instantáneo de rotación se mueve con respecto al disco. La principal ubicación preferida del eje de movimiento instantáneo de rotación para la región lumbar de la espina se encuentra principalmente en la mitad posterior del espacio del disco o próximo a la placa terminal adyacente, especialmente próximo a la placa terminal inferior/caudal, la principal ubicación del movimiento instantáneo del eje de rotación para la región torácica de la espina se encuentra en la porción inferior del espacio del disco o próximo al caudal del cuerpo vertebral que se extiende posteriormente dentro del canal medular, y la principal ubicación del movimiento instantáneo del eje de rotación de la región cervical de la espina se encuentra preferentemente en la mitad posterior del cuerpo del caudal vertebral.
También similar al disco intervertebral natural, las características de respuesta del disco intervertebral artificial son preferentemente no lineales. Por ejemplo, en respuesta a la continua compresión del eje, el disco artificial intervertebral preferentemente se somete a una gran cantidad inicial de compresión seguida de una disminución no lineal de la compresión.
En referencia a los dibujos adjuntos, las formas de realización preferidas y las características del disco intervertebral artificial son meramente ilustrativas. Se contempla que una o más características o elementos de las distintas formas de realización pueden ser combinadas o usadas singularmente, y que las modificaciones o de las distintas formas de realización, tan bien como, las otras formas de realización se contemplan y serán evidentes en las personas detalladas en el articulo.
En referencia inicial a las Figuras 1 y 2, se muestra una vista perspectiva de una forma de realización como ejemplo de un disco artificial intervertebral 10. Como se observa, el disco 10 tiene forma de alubia que incluye un lado anterior 11, un lado posterior 13, y primero y segundo lado lateral 15, 17, respectivamente. El lado anterior 11 y laterales 15, 17 son todos sustancialmente convexos en forma mientras que el lado posterior 13 es sustancialmente cóncavo en forma. Sin embargo, el disco 10 puede tomar otras formas que preferentemente concuerdan geométricamente y anatómicamente con los cuerpos vertebrales adyacentes que incluye, pero no está limitado a la forma circular, oval, elipsoide, anular, en forma de D, en forma de C, etc.
Como se muestra, el disco intervertebral 10 incluye una placa terminal superior 12, una placa terminal inferior 14 y una membrana elástica 16, la membrana elástica 16 generalmente se extiende desde la placa terminal superior 12 a la placa terminal inferior 14 y está ubicada, preferentemente, próxima a la periferia externa del disco 10. Alternativamente, la membrana elástica 16 puede rodear y/o encapsular las placas terminales superior e inferior 12, 14. La membrana elástica 16 en combinación con las placas terminales superior e inferior 12, 14 puede definir un volumen interior que puede estar parcialmente lleno con un fluido 22. La membrana elástica 16 preferentemente está formada de un elastómero como el poliuretano, silicona, un polímero trenzado, o cualquier otro material elástico apropiado conocido en este articulo. La membrana elástica puede no ser permeable. Alternativamente la membrana elástica 16 puede ser permeable o semipermeable para permitir que el fluido fluya dentro y fuera del interior del disco (de la manera descripta más detalladamente abajo). Preferentemente, la membrana elástica 16 puede resistir el movimiento de traslación entre las placas terminales superior e inferior 12, 14, y puede además evitar el crecimiento interno del tejido blando entre las placas terminales 12, 14, tan bien como contener cualquier tipo de partículas gastadas generadas dentro del volumen interior. La membrana elástica 16 puede estar adjunta a las placas terminales superior e inferior 12, 14 mediante cualquier método de fijación conocido en este arte, que incluye, pero sin limitación, a agentes de unión, soldadura ultrasónica, tornillo, uñas, cuñas mecánicas y clavijas.
Alternativamente, la membrana elástica 16 puede encontrarse en la forma de fuelle asumiendo la forma de "acordeón", permitiendo la expansión y contracción según las distintas condiciones de carga. El fuelle debe estar adjunto de manera rígida a las placas terminales superior e inferior 12, 14 por cualquier método conocido en este arte. Que incluye, pero no está limitado a un surco circular formado en cada placa terminal 12, 14, agentes de unión, soldadura ultrasónica, tornillos, uñas, cuñas mecánicas y clavijas. Preferentemente, el fuelle está hecho de metal, aunque cualquier otro material como elastómero o polímero puede usarse.
El disco 10 también puede incluir un válvula 20, la válvula 20 provee acceso al interior 19 del disco 10 para que el fluido pueda ser inyectado dentro, o removido del interior 19 del disco 10. La válvula 20 es preferentemente de un solo corredor, como es sabido por los especialistas en este articulo, para que el fluido, una vez inyectado, no pueda escapara desde el interior 19 del disco 10. Como se muestra en las Figuras 1 y 2, la válvula 20 preferentemente se ubica entre la membrana elástica 16, y alternativamente, sin embargo, la válvula 20 puede estar ubicada entre las placas terminales superior y/o inferior 12, 14 como se muestra en la Figura 2a. Cuando se ubica la válvula sobre las placas terminales superior y/o inferior 12, 14, se incluye preferentemente un corredor 30 para interconectar la válvula 20 con el interior 19 del disco 10.
El fluido 22 provisto en el volumen interior puede ser un gas, un liquido, un gel, o la combinación de los mismos. Cuando se provee un gas como medio de llenado para el volumen interior, o cuando se provee la combinación de gas y liquido, la última presión de gas dentro del volumen interior debe ser seleccionada para proveer un shock de absorción adecuado durante la compresión del eje del disco 10. El fluido también puede permitir la articulación o movimiento limitado de la placa terminal superior 12 y la placa terminal inferior 14 entre ellas. Preferentemente, el fluido es un liquido incompresible, por ejemplo, una solución salina. En el uso, el fluido 22 puede inyectarse dentro del interior 19 del disco 10 antes de la inserción del disco 10 entre las vértebras adyacentes. Alternativamente, el fluido 22 se puede inyectar in situ para facilitar la inserción del disco 10 y la subsecuente distracción entre las vértebras adyacentes. Las capacidades de rigidez y distracción del disco 10 puede ser una función de la cantidad de liquido de fluido 22 inyectado dentro del interior 19 del disco 10 y/o la naturaleza elástica de la membrana 16. Generalmente, cuanto más fluido 22 se inyecte en el interior 19 del disco 10, más rígido será el disco 10, y tendrá mayor capacidad de distracción. Además, la flexibilidad y la mayor articulación pueden alcanzarse mediante el llenado de sólo una porción del interior del volumen 19 del disco 10. Finalmente, el llenado variable del interior 19 del disco 10 con fluido 22 permite la totalidad altura H del disco 10 para que cambie según sea necesario dependiendo de las necesidades individuales del paciente.
Según se muestra en la Figura 2a, la placa terminal superior 12 posee una superficie interna provista de un alvéolo arqueado 32, mientras que la placa termina inferior 14 posee una superficie interna provista de una protrusión arqueada 34, o viceversa. El alvéolo 32 y la protrusión 34 están configurados y dimensionados para encastrar, o para corresponder generalmente entre si. El tipo y cantidad de articulación deseada puede dictar la curvatura del alvéolo 32, luego el disco 10 puede proveer mayor soporte pero menor movimiento predeterminado. Alternativamente, si el alvéolo 32 tiene un mayor radio que la profusión 34, el disco contará con mayor articulación. Además, la profusión 34 y/o el alvéolo 32 pueden también incorporar una porción plana que permita el movimiento de translación de la placa terminal superior 12 con respecto a la placa terminal inferior 14. Al permitir la traslación, el disco 10 puede proveer un movimiento instantáneo del eje de rotación de la manera en que fue explicado anteriormente.
También es posible para el alvéolo 32 y la profusión 34 adquirir contornos más allá de los descriptos más arriba con el fin de lograr la articulación deseada. Además, mientras el alvéolo 32 y la profusión 34 se muestran con contornos que por lo general permiten unir sus superficies, es posible proveer contornos que no se unan para que el alvéolo 32 y la protusión 34 adquieran la articulación deseada.
El uso de un volumen interior lleno de fluido 19 en combinación con una superficie de articulación puede permitir al alvéolo 32 y la protrusión 34 que se traslade más fácilmente con respecto a cada uno de ellos reduciendo la fricción entre las superficies deslizantes.
Alternativamente, cuando el fluido es un gas comprimido, las superficies de la articulación puede estar de manera no constante comprometida, pero puedo sólo comprometerse cuando la suficiente fuerza de compresión se ubica en el disco mediante las vértebras adyacentes. Además, el disco de esta forma de realización tendría un aspecto de desempeño dual, de acuerdo con un escenario de carga que se desempeñe como disco lleno de fluido, y según un segundo escenario que se desempeñe como un disco articulado de protrusión/alvéolo.
Según la ubicación en la espina en donde se implante, el disco 10 puede restaurar con preferencia la altura en un rango que se extiende de aproximadamente 4 milímetros (mm) a aproximadamente 2 6 mm. Además, el disco 10 con preferencia también soluciona la lordosis en un rango que se extiende de aproximadamente 0º a aproximadamente 20º. El disco 10 con preferencia también puede restaurar la rigidez en un rango que se extiende de aproximadamente 1 metro Newton por grado (Nm/gr) a aproximadamente 11 Nm/gr en rotación axial, de aproximadamente 0 Nm/gr a aproximadamente 7 Nm/gr en flexión/extensión, y de aproximadamente 0 Nm/gr a aproximadamente 5 Nm/gr en curvatura lateral. Además, el disco 10 provee con preferencia una rigidez de compresión de aproximadamente 100 N/mm a aproximadamente 5000 N/mm y una rigidez de tensión de aproximadamente 50 N/mm a aproximadamente 1000 N/mm. Además, según la ubicación de la espina donde se implante el disco 10, el disco intervertebral 10 permite con preferencia un rango de movimiento de aproximadamente 5º a aproximadamente 45º en la flexión/extensión, de aproximadamente 3º a aproximadamente 33º en la curvatura lateral, y de aproximadamente 1º a aproximadamente 60º en la rotación axial. El disco intervertebral 10 también permite con preferencia la compresión axial en un rango de aproximadamente 0,2 mm a aproximadamente 2 mm.
Preferentemente las placas terminales superior e inferior 12, 14 están formadas de metal, como el titanio, acero inoxidable, aleaciones de titanio, aleaciones de cromo-cobalto, aleaciones amorfas. Alternativamente, sin embargo, las placas terminales superior e inferior 12, 14 pueden estar formadas por cerámica, compuestos, polímeros, como PEEK o ÜHMWPE, hueso, que incluye hueso cortical, hueso esponjoso, aloinjerto, autoinjerto, xenoinjerto, hueso desmineralizado o parcialmente desmineralizado, o cualquier otro tipo de material adecuado que sirva como soporte de la carga. Con mayor preferencia, los materiales elegidos para las placas terminales, en combinación con el fluido, pueden ser seleccionados para minimizar el uso.
Además, con preferencia, cualquier superficie de articulación en los discos intervertebrales de la presente invención incluye una superficie lustrada o de acabado similar al acabo del diamante. Acabado tipo TiNi, etc., con el fin de minimizar el uso, disminuir la generación de partículas, e incrementar la vida del disco.
La superficie externa de las placas terminales superior e inferior pueden ser sustancialmente planas, en forma de cuña, etc. Las superficies externas de las placas terminales superior e inferior 12, 14, además pueden tener forma de cúpula con su radio definido en los planos sagital y coronal para que generalmente coincida la forma del de los extremos de la vértebra adyacente, por lo tanto provee un mejor encastre in situ.
Además, como se demuestra en las Figuras 1 a 2a, el disco 10 puede incluir características de migración resistentes, como por ejemplo, estructuras similares al clavo 18 sobre las superficies externas de las placas terminales superior e inferior 12, 14. Las características de resistencia migratoria pueden facilitar el compromiso del disco 10 con los extremos de las vértebra adyacente mediante la provisión de un interbloqueo mecánico como resultado de la penetración y/o deformación de las extremidades de las vértebras adyacentes. El mecanismo de estabilidad inicial logrado por los clavos 18, por ejemplo, minimiza los riesgos de inestabilidad postoperatoria, movimiento, dislocación o expulsión del disco 10. Otras características resistentes a la migración pueden incluir, sin limitarse a, separadores, dientes, dientes desplazables, clavos desplazables, clavos flexibles, placas, placas insertables o expansibles, soportes, tornillos, bordes, serraciones, u otras texturas similares sobre las superficies externas de las placas terminales superior e inferior 12, 14. Como se muestra en la Figura 3a, los clavos desplazables 21 pueden ser provistos, y un mecanismo de leva 23 se puede utilizar para desplazare los clavos 21. Alternativamente, y como se muestra en la Figura 3b, un instrumento se puede utilizar para desplazar a los clavos 21. Como se muestra en las Figuras 3c hasta 3e, respectivamente, se muestran ejemplos de clavos flexibles 24, dientes en forma 25, y soportes 26. Alternativamente y además, los agentes de unión como los cementos de fosfato de calcio, etc., pueden también utilizarse para asegurar el disco 10 de la vértebra adyacente.
Además, las placas terminales superior e inferior 12, 14 también pueden estar recubiertas por un crecimiento óseo induciendo sustancia, como la hidroxiapatita, con el fin de promover en crecimiento interno óseo para asegurar permanentemente el disco 10 de las vértebras adyacentes. Alternativamente, las placas terminales superior e inferior 12, 14 pueden tener una superficie áspera o porosa que facilite el crecimiento interno óseo. Alternativamente, las placas terminales superior e inferior 12, 14 pueden tener láminas de placas terminales tratadas con láser para crear una estructura porosa, o pueden formar un puente osteoconductor y/u osteoinductivo. Las placas terminales 12, 14 también pueden estar formadas por material osteoconductor y/u osteoinductor para promover el crecimiento interno óseo. Las placas terminales 12, 14 además incluyen una membrana y/o barrera que limita la profundidad permitida del crecimiento interno óseo.
Las placas terminales 12, 14 también pueden tener un implante adjunto de instrumentación, que guía y retiene las estructuras. Por ejemplo, las placas terminales 12, 14 pueden tener perforaciones, ranuras, hilos, o cola de milano con el fin de permitir la utilización de la herramienta para realizar el implante del disco 10 y/o para distraer las vértebras. Por ejemplo, el disco puede incluir una ranura formada por las placas terminales superior e inferior 12, 14, la ranura configurada para recibir el instrumento de implante, un distractor o ambos.
Como resultado de los componentes materiales y estructurales utilizados, el disco 10 puede permitir flexión/exten-
sión, curvatura lateral, rotación axial, y translación, dependiendo de la carga impartida en el disco vertebral. Además, según las distintas condiciones de carga espinales que resultan de los movimientos espinales, el fluido 22 puede moverse dentro del volumen interior, ya sea por la compresión (en el caso de un gas), o por el movimiento radial hacia fuera a medida que la membrana se expande, permitiendo que las placas terminales se muevan entre si. Esta variación de movimiento o desplazamiento del fluido 22 provee un movimiento instantáneo del eje de rotación.
La presente invención no se limita a las formas de realización especificas descriptas en el presente.
Además, se debe comprender que el alcance de las variaciones y modificaciones de esta invención puede ocurrir para aquellos experimentados en el arte hacia los cuales esta invención es dirigida. Por ejemplo, algunas porciones de implantes que se muestran en el presente pueden estar formadas por hueso, como aloinjerto, autoinjerto, y xenoinjerto, que pueden estar parcialmente o totalmente desmineralizados. Además, algunos implantes pueden incluir material óseo u otro tipo de crecimiento óseo induciendo material en su interior o sobre/en las placas terminales. Dichas sustancias en los interiores pueden interactuar con la anatomía que las rodea, como canales u otro tipo de orificios formados por paredes de implantes. Además, los marcadores de alineación postoperación pueden utilizarse para asistir con el implante de los discos vertebrales. También, los discos intervertebrales pueden ser rígidos en situaciones donde es necesaria una fusión. Los discos intervertebrales pueden ser rígidos, por ejemplo, permitiendo la fusión entre las placas terminales, insertando espaciadores entre las placas terminales, o inyectando un líquido solidificado entre las placas terminales. Según esto, todas las modificaciones convenientes que se encuentren disponibles para aquellos experimentados en este arte mediante la revelación que aquí se realiza y que se encuentran dentro del alcance y el espíritu de la presente invención, deben ser incluidas como formas de realización adicionales a la presente invención. El alcance de la presente invención se encuentra debidamente definido como es establecido en las reivindicaciones adjuntas.

Claims (20)

  1. \global\parskip0.900000\baselineskip
    1. Un disco intervertebral (10) para su ubicación entre la primera y segunda vértebra incluye:
    una placa terminal superior (12) con una primera superficie interna y una primera superficie externa, la primera superficie externa contacta a la primera vértebra;
    una placa terminal inferior (14) que tiene segunda superficie interna y una segunda superficie externa, la segunda superficie externa contacta a la segunda vértebra,
    una membrana (16) que se extiende desde la placa terminal superior (12) y la placa terminal inferior (14),
    un volumen interior (19) definido entre las placas terminales (12, 14) y la membrana elástica (16),
    una válvula (20) en comunicación con el volumen interior (19) llenando por lo menos parcialmente el volumen con un fluido (22), en donde
    una de las primeras y segundas superficies internas tiene un alvéolo (32) y la otra de la primera y segunda superficies interna tienen una protrusión (34), en donde la protrusión (34) se configura de manera convexa para articular dentro del alvéolo cóncavo (32), caracterizado porque
    el alvéolo (32) y la protrusión (34) están configurados y poseen las dimensiones para acoplarse o para que generalmente encastren entre si, y la membrana elástica (16) está configurada alrededor del alvéolo (32) y la protrusión (34), permitiendo flexión, extensión, curvatura lateral, rotación y traslación,
    en donde la traslación es un movimiento generalmente transverso al eje de la columna vertebral
    por lo que permite movimiento instantáneo de rotación del eje.
  2. 2. Un disco intervertebral (10) de acuerdo con la reivindicación 1, en donde la protrusión (34) posee el mismo radio que el alvéolo (32) lo que provee de un mayor soporte pero de un movimiento más limitado.
  3. 3. Un disco intervertebral (10) de acuerdo con la reivindicación 1, en donde el alvéolo (32) tiene un radio mayor que la protrusión (34) que brinda una mayor articulación.
  4. 4. Un disco intervertebral (10) de acuerdo con la reivindicación 1, en donde la protrusión (34) y/o alvéolo (32) incorpora una porción plana que permite el movimiento de traslación de la placa terminal superior (12) con respecto a la placa terminal inferior (14).
  5. 5. Un disco intervertebral (10) de acuerdo con la reivindicación 1, en donde al menos una porción de la válvula (20) se coloca dentro de la membrana (16) .
  6. 6. Un disco intervertebral (10) de acuerdo con cualquiera de las reivindicaciones anteriores 1-2, en donde al menos una porción de membrana (16) se encuentra entre las placas superior e inferior (12, 14).
  7. 7. Un disco intervertebral (10) de acuerdo con cualquiera de las reivindicaciones anteriores 1-3, en donde la membrana (16) encapsula las placas terminales superior e inferior (12, 14).
  8. 8. Un disco intervertebral (10) de acuerdo con cualquiera de las reivindicaciones anteriores 1-4, en donde la membrana (16) está formada por material elastomérico.
  9. 9. Un disco intervertebral (10) de acuerdo con cualquiera de las reivindicaciones anteriores 1-5, en donde la membrana (16) forma un fuelle.
  10. 10. Un disco intervertebral (10) de acuerdo con cualquiera de las reivindicaciones anteriores 1-6 en donde el fluido (22) es incompresible.
  11. 11. Un disco intervertebral (10) de acuerdo con cualquiera de las reivindicaciones anteriores 1-7, en donde al menos una de las placas terminales (12, 14) está formada de material seleccionado de un grupo de metal consistente, polímero, cerámica o compuesto.
  12. 12. Un disco intervertebral (10) de acuerdo con cualquier de las reivindicaciones anteriores 1-8, en donde al menos una de las placas terminales (12, 14) está formada por material óseo seleccionado de un grupo cortical, hueso esponjoso, aloinjerto, xenoinjerto, hueso desmineralizado o parcialmente desmineralizado.
  13. 13. Un disco intervertebral (10) de acuerdo con cualquier de las reivindicaciones anteriores 1-9, que además comprende las estructuras resistentes a la migración dispuestas sobre al menos una de la primera o segunda superficie externa.
    \global\parskip1.000000\baselineskip
  14. 14. Un disco intervertebral (10) de acuerdo con cualquier de las reivindicaciones anteriores 1-10, que además comprende los medios de fijación permanente dispuestos sobre al menos una de la primera o segunda superficie externa.
  15. 15. Un disco intervertebral (10) de acuerdo con cualquier de las reivindicaciones anteriores 1-11, que además comprende un adjunto de instrumento de implante, que guía o retiene las estructuras dispuestas sobre al menos una de la primera o segunda superficie externa.
  16. 16. Un disco intervertebral (10) de acuerdo con la reivindicación 1, en donde al menos una de las placas terminales (12, 14) posee una forma de cúpula con su radio que encastra con los extremos de la vértebra adyacente.
  17. 17. Un disco intervertebral (10) de acuerdo con la reivindicación 13, en donde las estructuras resistentes a la migración son clavos (18), clavos desplazables (21), clavos flexibles (24), dientes (25) o soportes en forma de estructuras (26).
  18. 18. Un disco intervertebral (10) de acuerdo con la reivindicación 17, en donde el mecanismo de leva (23) o un instrumento es utilizado para operar los clavos desplazables (21).
  19. 19. Un disco intervertebral (10) de acuerdo con la reivindicación 1, en donde el disco (10) tiene forma de alubia que incluye un lado anterior (11), un lado posterior (13) y el primer y segundo lado lateral (15, 17) son sustancialmente convexos en forma y el lado posterior (13) es sustancialmente cóncavo.
  20. 20. Un disco intervertebral (10) de acuerdo con la reivindicación 19, en donde el disco (10) posee una forma que se adapta geométrica y anatómicamente con los cuerpos de la vértebra adyacente y son circulares, ovales, elipsoides, anular, en forma de D, en forma de C.
ES03788497T 2002-08-15 2003-08-15 Implante de disco intervertebral. Expired - Lifetime ES2310255T3 (es)

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