ES2217796T3 - Separador de injerto intervertebral. - Google Patents

Separador de injerto intervertebral.

Info

Publication number
ES2217796T3
ES2217796T3 ES99940102T ES99940102T ES2217796T3 ES 2217796 T3 ES2217796 T3 ES 2217796T3 ES 99940102 T ES99940102 T ES 99940102T ES 99940102 T ES99940102 T ES 99940102T ES 2217796 T3 ES2217796 T3 ES 2217796T3
Authority
ES
Spain
Prior art keywords
implant
implant according
bone
separator
parts
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
ES99940102T
Other languages
English (en)
Inventor
David Paul
Hansjuerg Emch
Beat Schenk
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.)
AO Technology AG
Original Assignee
Synthes AG Chur
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 AG Chur filed Critical Synthes AG Chur
Priority claimed from US09/814,214 external-priority patent/US7087082B2/en
Application granted granted Critical
Publication of ES2217796T3 publication Critical patent/ES2217796T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/006Pressing and sintering powders, granules or fibres
    • 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
    • A61F2/28Bones
    • 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
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • 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
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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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    • A61F2/30724Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity
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    • A61F2/30965Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
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    • A61F2/02Prostheses implantable into the body
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    • A61F2/442Intervertebral or spinal discs, e.g. resilient
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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
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • 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
    • A61F2/4465Joints 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 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
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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 for implanting artificial joints
    • A61F2/4603Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
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    • 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
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    • A61F2/46Special tools for implanting artificial joints
    • A61F2/4644Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material
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    • A61F2/28Bones
    • A61F2002/2817Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
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    • A61F2002/30011Material 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 porosity
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    • A61F2002/30057Material 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 made from both cortical and cancellous adjacent parts
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    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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Abstract

Implante (10, 40, 50 70, 80) comprendiendo una porción de hueso alógeno y teniendo una pluralidad de paredes laterales planas o curvas (18, 22, 26, 28), una superficie superior (14) y una superficie inferior (16) con el fin de ajustarse como un injerto entre las superficies del hueso o de los fragmentos de huesos adyacentes, caracterizado porque A) las dichas superficies superior e inferior (14, 16) están provistas de una estructura en tres dimensiones para interconectarse con dichas superficies de hueso o de fragmentos de hueso adyacentes, y porque B) dicho implante (10, 40, 50, 70, 80) esta combinado con un separador discreto (120) comprendiendo una porción de tejido oseó alógeno conformada en tamaño y forma con una parte de un placa vertebral y teniendo un perfil en forma acuñada, en el cual las superficies superior e inferior (14, 16) de dicho separador (120) son sensiblemente lisas y el pasaje entre las superficies superior e inferior y los lados anterior (26) y laterales (18, 22) del separador tiene lugar por los bordes curvos (30) para facilitar la implantación del separador (120).

Description

Separador de injerto intervertebral.
La presente invención esta dirigida a un implante alógeno de acuerdo con la definición de la reivindicación 1. La misma hace referencia mas particularmente a un implante alógeno intervertebral en correspondencia en tamaño y en forma con las placas extremas de las vértebras.
Un determinado número de condiciones médicas como una compresión de las raíces nerviosas de la medula espinal, enfermedades degenerativas de los discos y la espondilolistesis pueden provocar dolores severos en la parte inferior de la espalda. La fusión intervertebral es un procedimiento quirúrgico para reducir el dolor en la parte inferior de la espalda. En una fusión intervertebral lumbar posterior ("PLIF") dos cuerpos de vértebras adyacentes son fusionados juntos mediante la retirada del disco afectado y la inserción de un implante que permitirá al hueso crecer entre los dos cuerpos vertebrales para cubrir la separación dejada por la retirada del disco.
Un determinado número de diferentes implantes y de materiales de implante han sido utilizados en el procedimiento PLIF con un éxito variable. Los implantes utilizados actualmente para el PLIF comprenden unas cajas en titanio roscadas y los injertos. Las cajas en titanio roscadas presentan el inconveniente de tener que agujerear y taladrar las placas vertebrales extremas para las finalidades de inserción. Además, la incidencia de una compresión durante un uso prolongado no es conocida. Debido a la incompatibilidad del titanio con el IRM, la fusión es difícil de determinar. Finalmente, la restauración de la lordosis, es decir la curvatura natural de la columna lumbar, es muy difícil cuando se utiliza una caja cilíndrica en titanio.
Los injertos son secciones de hueso efectuadas en un hueso largo de un donante. Una sección transversal del hueso es efectuada y tratada utilizando las técnicas conocidas para preservar el injerto hasta la implantación y reducir el riesgo de una reacción inmunológica negativa cuando el mismo es implantado. Por ejemplo, la patente US nº 4 678.470 divulga un procedimiento para tratar un material de injerto óseo que utiliza el curtido al glutaraldehido para producir un material no antígeno bio-compatible. Los injertos tienen propiedades mecánicas que son similares al blindaje que tiene lugar con los implantes metálicos. Los mismos son también compatibles con el IRM de forma que es posible el asegurar más precisamente la fusión y favorecer la formación ósea, es decir la osteoconductividad. Aun cuando la naturaleza osteoconductora del injerto suministra una interconexión biológica entre el injerto y las vértebras para una resistencia mecánica de larga duración, la resistencia mecánica inicial y a corto plazo la resistencia mecánica de la superficie de contacto entre el injerto y las vértebras fueron defectuosas como lo prueba la posibilidad de que el injerto sea expulsado después de la implantación.
Los injertos actualmente disponibles en el comercio son simplemente secciones de hueso que no están específicamente destinadas a ser utilizados en el procedimiento PLIF. Por consiguiente, la fusión de los cuerpos vertebrales no tiene lugar en una posición anatómica óptima. Un cirujano puede proceder a una determinada colocación en forma y en dimensión intra-operatoria mínima para adaptar el injerto a la anatomía espinal del paciente. Sin embargo, una importante adaptación en forma y dimensión no es posible por razón de la naturaleza del injerto. Incluso si una colocación en forma y en dimensión extensiva fuera posible, la capacidad de un cirujano para colocar el injerto manualmente en la forma y en las dimensiones deseadas esta severamente limitada.
La mayoría de los implantes PLIF, tanto se trate de cajas roscadas o un injerto, están disponibles en diferentes tamaños y tienen longitudes que varían en función de la altura del implante. Por ejemplo, la longitud de una caja cilíndrica será sensiblemente equivalente a la altura del implante. Aunque las alturas más grandes pueden ser clínicamente indicadas, los implantes más grandes no son en general deseados, teniendo en cuenta que una anchura incrementada requiere la retirada de una parte más grande de la cara, lo que puede arrastrar a una disminución de la estabilidad y una retracción más grande de las raíces de los nervios, lo cual puede conducir a un daño temporal o permanente de los nervios.
Se conoce por la patente US-A 5 514 180 concedida a HEGGENESS ET AL. Un dispositivo intervertebral protético bajo la forma de un simple cuerpo cilíndrico teniendo unas paredes laterales curvadas y unas superficies superior e inferior lisas con el fin de adaptarse entre las superficies de las vértebras adyacentes. Este implante conocido puede comprender unas secciones de injerto sin divulgar los detalles de una tal forma de realización.
Como ilustra la argumentación anterior, se tiene necesidad de un implante mejor para fusionar las vértebras.
La invención resuelve el problema propuesto con un implante que presenta las características de la reivindicación 1. Realizaciones ventajosas adicionales de la invención están caracterizadas en las sub-reivindicaciones.
La presente invención hace referencia a un implante intervertebral alógeno para utilización cuando la fusión quirúrgica de los cuerpos vertebrales esta indicada. En una forma de realización, el implante comprende una porción de hueso alógeno en correspondencia de tamaño y forma con una parte de las placas vertebrales y que tiene un perfil en forma de cuña con una pluralidad de dientes situados sobre las superficies superior e inferior. Las superficies superior e inferior pueden ser unas superficies de placas lisas planas o curvas para imitar la topografía de las placas extremas. El implante tiene un canal sobre al menos un lado para recibir una herramienta quirúrgica. Este canal se desplaza en la dirección anterior para aceptar una variedad de aproximaciones quirúrgicas. Un orificio roscado sobre el lado anterior, posterior, posterior-lateral o lateral puede estar previsto para recibir un brazo roscado de una herramienta de inserción.
En una otra forma de realización, el implante tiene un espacio interior para recibir un material osteo-conductor destinado a favorecer la formación de un hueso nuevo.
En otra forma de realización, el implante esta hecho en dos mitades; una parte superior teniendo una superficie de conexión superior y una parte inferior teniendo una superficie de conexión inferior. La superficie de conexión superior se acopla con la superficie de conexión inferior cuando las partes superior e inferior son unidas. Las partes superior e inferior tienen unos orificios que se alinean para recibir un pasador con el fin de asegurar las partes superior e inferior. El pasador puede estar hecho de un hueso alógeno.
En una forma de realización suplementaria, el lado medio del implante tiene un canto escotado de forma que, cuando un primer implante es implantado con un segundo implante con los lados medios enfrentados entre sí, los bordes escotados definen un espacio cilíndrico.
La presente invención hace referencia también a un separador discreto utilizado con una cualquiera de las otras formas de realización del implante. En una forma de realización, el separador comprende una porción de hueso alógeno de conformidad en tamaño y forma con una parte de las placas vertebrales extremas y un perfil en forma de cuña con las superficies superior e inferior sensiblemente lisas. Las regiones de intersección entre las superficies superior e inferior y al menos dos lados laterales y la región de intersección entre los lados anterior y posterior y el mismo lado lateral tienen unas superficies curvas para facilitar la implantación del separador. Por consiguiente, el separador podría ser implantado por una abertura sobre un lado del canal raquídeo y desplazado con un instrumento quirúrgico hacia el lado opuesto.
La invención y las formas de realización suplementarias de la invención son explicadas de una forma todavía más detallada haciendo referencia a la ilustración en parte esquemática de las formas de realización.
En las figuras:
La Figura 1, es una vista en planta superior de una primera realización del implante de acuerdo con la invención;
La Figura 2, es una vista lateral del implante de la figura 1,
La Figura 3, es una vista posterior del implante de la Figura 1.
La Figura 4, es una vista en planta superior de una segunda forma de realización del implante,
La Figura 5, es una vista lateral del implante de la figura 4.
La Figura 6, es una vista en planta superior de una tercera forma de realización del implante;
La Figura 7, es una vista lateral del implante de la figura 6,
La Figura 8A, es una vista en planta superior de una superficie de conexión superior de una parte superior del implante de la figura 6,
La Figura 8B, es una vista en planta superior de una superficie de conexión inferior de una parte inferior del implante de la figura 6,
La Figura 9, es una vista en perspectiva de una cuarta forma de realización del implante,
La Figura 10A, es una vista lateral de una forma de realización del dentado del implante,
La Figura 10B, es una vista lateral de una segunda forma de realización del dentado del implante,
La Figura 11, es una vista lateral de una forma de realización del implante similar a la realización de las figuras 6-8,
La Figura 12, es una vista en planta superior de un hueso vertebral característico de aquellos de la columna cervical, torácica o lumbar,
La Figura 13, es una vista lateral de los huesos vertebrales alineados secuencialmente, tales como los que se encuentran en la columna cervical, torácica o lumbar.
La Figura 14, es una vista posterior de una secuencia de vértebras, y
La Figura 15, es una vista del extremo de otra forma de realización del implante.
La Figura 1, muestra una vista en planta superior de una primera forma de realización de un separador de injerto intervertebral o de un implante (10) de acuerdo con la presente invención. El implante (10) de conformidad en tamaño y en forma con una parte de las placas vertebrales extremas entre las cuales el implante (10) será implantado. Como el implante (10) es un injerto, el implante (10) favorece la formación de un nuevo hueso para fusionar los dos cuerpos vertebrales juntos. Aunque el implante (10) sea susceptible de ser utilizado de forma predominante en la región lumbar de la columna, el implante (10) puede ser configurado para la implantación en cualquier región de la columna. El implante tiene una pluralidad de dientes (12) sobre las superficies superior e inferior (14), (16) que suministran una interconexión mecánica entre el implante y las placas extremas. Los dientes (12) suministran la interconexión mecánica penetrando en las placas extremas. La estabilidad mecánica inicial suministrada por los dientes (12) minimiza el riesgo de expulsión postoperatoria del implante (10). Los dientes pueden ser de forma piramidal (Figura 10A). Preferiblemente, el ángulo formado desde la punta a la base es aproximadamente de 60º. Alternativamente, los dientes (12) tienen una forma en diente de sierra con el diente de la sierra desplazándose en el sentido antero-posterior (Figura 10B).
Como lo muestran las figuras 2 y 3, un primer lado lateral (18) tiene un canal (20) y un segundo lado lateral (22) tiene también un canal (20). Los canales (20) están dimensionados para recibir un instrumento quirúrgico como un injertador para implantar el implante (10). Si el injertador tiene un brazo fileteado, el implante (10) puede estar provisto de un orificio fileteado (24). En la figura 2, el canal (20) es mostrado como prolongado solamente en parte a lo largo de un primer lado lateral (18). El canal (20) puede extenderse a lo largo de toda la longitud del primer lado lateral (18) como es mostrado en la forma de realización de la figura 5. En la figura 3, los canales (20) están mostrados sobre el primer y el segundo lado lateral (18), (22). Es de señalar que el implante (10) puede también no tener ningún canal o no tener canal más que sobre un lado lateral como muestra la forma de realización de la figura 9.
Las dimensiones del implante (10) pueden variar para adaptarse a la anatomía de un paciente. De forma típica, el implante (10) tendría una anchura entre 6 y 15 mm (en el sentido medio-lateral), una longitud entre 15 y 30 mm (en el sentido antero-posterior) y una altura entre 4 y 30 mm (altura máxima en el sentido superior-inferior). El tamaño del implante (10) permite el implantar el implante (10) utilizando los procedimientos convencionales de la cirugía abierta o los procedimientos poco invasivos, como la cirugía por laparoscopía. Adicionalmente, puesto que la anchura es mantenida en una escala de tamaño restringida y no se incrementa necesariamente con la altura del implante, unos implantes más grandes pueden ser utilizados sin que los implantes más anchos sean necesarios. Por consiguiente, la retirada de la cara y la retracción de las raíces nerviosas pueden permanecer en un mínimo.
Con el fin de restaurar la curvatura natural de la columna después de que el disco afectado ha sido retirado, el implante (10) tiene un perfil en forma de cuña. Como se muestra en la figura 2, esta forma de cuña da como resultado una disminución gradual de la altura de un lado anterior (26) a un lado posterior (28). En términos anatómicos, la curva natural de la columna lumbar es designada por el termino lordosis. Cuando el implante (10) es utilizado en la región lumbar, el ángulo formado por la cuña debería de ser aproximadamente entre 4,2º y 15º con el fin de que la forma de la cuña sea de una forma lordotica que imite a la anatomía de la columna lumbar.
Con vistas a facilitar la inserción del implante (10) el pasaje del lado anterior (26) a las superficies superior e inferior (14), (16) se efectúa por los bordes redondeados (30). Los bordes redondeados (30) permiten al implante (10) deslizarse entre las placas extremas minimizando la distracción necesaria de las placas extremas.
Aun cuando el implante (10) es típicamente una pieza sólida de hueso alógeno, el implante (10) puede estar provisto con un interior hueco para formar un espacio interior. Este espacio interior puede ser rellenado de fragmentos de hueso o de cualquier otro material osteo-conductor para favorecer todavía más la formación de nuevo hueso.
La Figura 4, muestra una vista en planta superior de una segunda forma de realización de un implante (40) de acuerdo con la presente invención. En general la mayor parte de la estructura del implante (40) es similar o comparable a la estructura del implante (10). Por consiguiente, la discusión de los componentes similares no se considera necesaria. Las superficies superior e inferior (14), (16) del implante (10) son unas superficies planas lisas. Como se ve mejor sobre la figura 5, las superficies superior e inferior (14), (16) del implante (40) son unas superficies curvas que conservan todavía el perfil en forma de cuña. Las superficies curvas de las superficies superior e inferior (14), (16) del implante (40) son una imagen espejo de la topografía de las placas vertebrales. Por consiguiente, las superficies curvas se conforman a los contornos de las placas extremas.
La Figura 6, muestra una vista en planta superior de una tercera forma de realización de un implante (50) de acuerdo con la presente invención. En general, la mayor parte de la estructura del implante (50) es similar o comparable a la estructura de los implantes (10), (40). Por consiguiente, la discusión de los componentes similares no se considera necesaria. Como se ve mejor sobre la figura 7, el implante (50) comprende una parte superior (52) unida a una parte inferior (54). Como puede ser difícil de obtener una sola sección de hueso alógeno a partir de la cual el implante (50) será fabricado, la fabricación del implante (50) en dos porciones, es decir la parte superior e inferior (52), (54) permite el utilizar unas secciones más pequeñas de hueso alógeno. Una superficie de conexión superior (56) y una superficie de conexión inferior (58) definen la superficie de contacto entre las partes superior e inferior (52), (54). Como muestran las figuras 8A y 8B, las superficies superior e inferior (56), (58) tienen unos nervios (60) que se acoplan con las ranuras (62) para interconectar las partes superior e inferior (52), (54). Los nervios (60) y las ranuras (62) son formados preferentemente, mediante fresado de las superficies superior e inferior (56) (58) en una primera dirección y a continuación fresando una segunda vez con las superficies superior e inferior (56), (58) orientados a 90º con respecto a la primera dirección.
Un pasador (64) pasando por unos orificios (56) alineados en las partes superior e inferior (52), (54) sirve para retener las porciones superior e inferior (52), (54) juntas. Aunque el pasador (64) puede ser fabricado en no importa que material bio-compatible, el pasador (64) esta hecho preferentemente en hueso alógeno. El número y la orientación de los pasadores (64) pueden variar.
La Figura 11, muestra una forma de realización de un implante (80) que, como el implante (50), esta hecho de múltiples piezas. En general, la mayor parte de la estructura del implante (80) es similar o comparable a la estructura de los implantes (10), (40) y (50). Por consiguiente, la discusión de los componentes similares no se estima necesaria. El implante (80) tiene una parte superior (82), una parte central (84) y una parte inferior (86). Como era el caso para el implante (50) las superficies entre las partes son unas superficies de acoplamiento con unos elementos de superficie interconectandose, como unos nervios y unas ranuras. Uno o varios pasadores mantienen preferentemente juntas las partes superior central e inferior (82), (84), (86).
La Figura 9, muestra una vista en perspectiva de una cuarta realización de un primer implante (70) de acuerdo con la presente invención. Un segundo implante (70) que es sensiblemente similar al primer implante (70) es igualmente mostrado. En general, la mayor parte de la estructura del primer y del segundo implante (70), (70') es similar o comparable a la estructura de los implantes (10), (40) (50). Por consiguiente, la discusión de los componentes similares no se ha estimado necesaria. Los primeros lados laterales (18) del primer y del segundo implante (70), (70') están escotados para tener una forma en C. Cuando el primero y el segundo implante (70), (70') son situados lado a lado con los primeros lados laterales (18) encarados, un espacio cilíndrico (72) es formado. Cuando el primer y el segundo implante (70), (70') son implantados juntos, el espacio cilíndrico (72) es llenado de material osteo-conductor para ayudar a favorecer la formación del hueso nuevo. El primer y segundo implantes (70), (70') pueden estar equipados con pasadores de enclavamiento (74) que se encajan en las aberturas (76) para mantener la relación espacial entre el primero y el segundo implantes (70), (70').
La utilización del implante de acuerdo con la presente invención será a continuación descrita haciendo referencia a las figuras (12), (14) y utilizando la artrodesis inter-somática lumbar por vía posterior como ejemplo. Como el implante de acuerdo con la presente invención se encuentra en correspondencia en tamaño y forma a una porción de las placas extremas (100) una planificación pre-operatoria es recomendada para una toma de dimensión adecuada. Es conveniente el determinar la altura apropiada del implante midiendo los discos intervertebrales (102) adyacentes sobre una radiografía lateral. El implante tiene que ser asentado firmemente estando estrechamente ajustado entre las placas (100) cuando el segmento es completamente distribuido. Es conveniente el utilizar el implante más grande posible para maximizar la estabilidad segmental. En razón de la variabilidad de los grados de magnificación de las radiografías las medidas son solamente una estimación.
Cuando el paciente esta en posición alargada sobre un cuadro lumbar, el equipo radiográfico puede ayudar a confirmar la posición intra-operatoria precisa del implante. El cirujano incide y disecciona lateralmente la piel a partir de una línea central y localiza la apófisis espinosa (104) la lamina (106) la duramáter (108) y las raíces nerviosas a los niveles apropiados. Conviene el preservar tanto como sea posible las caras (110) para suministrar una estabilidad al segmento intervertebral. El cirujano practica una laminotomía del aspecto medial de la faceta (110) refleja la duramáter (108) para exponer una ventana de aproximadamente 13 mm hacia el espacio del disco. El disco (102) es retirado por la ventana hasta que solamente permanece el anillo anterior (112) y el anillo lateral (114). Las capas superficiales de la totalidad de las placas extremas (100) cartilaginosas son igualmente retiradas para exponer el hueso. Una retirada excesiva del hueso subchondral puede debilitar la columna anterior. Además si la totalidad de la placa extrema es retirada, esto puede dar como resultado un hundimiento y una perdida de estabilidad segmental.
La separación puede ser efectuada por medio de un separador quirúrgico o de un implante separador de ensayo. En el primer procedimiento, las láminas del separador deben de ser insertadas completamente en el espacio discal con el fin de que las aristas en el extremo de las láminas descansen sobre el cuerpo vertebral (116). La fluoroscopia puede ayudar a confirmar que las lamas del separador son paralelas a las placas (100). La situación correcta orientara las empuñaduras del separador cranealmente, en particular en L5 - S1. La empuñadura del separador es presionada para separar el espacio interior. La separación es asegurada mediante la fijación de la tuerca rápida sobre la empuñadura.
Utilizando el tamaño determinado antes de la operación, un separador de ensayo es insertado en el espacio discal contra-lateral por impactación suave. La fluoroscopía y el juicio por tacto pueden ayudar a confirmar el ajuste del separador de ensayo hasta que un ajuste seguro es alcanzado. Utilizando bien las hendiduras bien el orificio roscado sobre el implante, el implante seleccionado es insertado en el espacio discal contra-lateral. Alternativamente, los canales sobre el implante permiten que la separación y la inserción tengan lugar del mismo lado. Independientemente del lado en el cual el implante es insertado, del tejido óseo reticulado autógeno o un sustituto óseo debe de ser situado en el aspecto anterior y medial del espacio discal vertebral antes de la colocación del segundo implante. El separador es retirado y un segundo implante de la misma altura que el primer implante es insertado en el espacio recurriendo a una impactación suave como precedentemente. Los implantes son preferentemente rebajados 2 - 4 mm más allá del borde posterior del cuerpo vertebral.
Como se ha señalado precedentemente, el implante de acuerdo con la presente invención puede ser insertado utilizando unos procedimientos poco invasivos. En determinados de estos procedimientos, solo un lado del cordón espinal debe de ser aproximado. Esto minimiza la retirada muscular, el tejido cicatricial en el canal y la retracción de las raíces nerviosas y la manipulación. En las situaciones clínicas en las cuales el emplazamiento bilateral de un implante es requerido, una implantación correcta sobre el lado opuesto a la incisión puede ser difícil. La Figura 15, muestra un separador achaflanado (120) que facilita el emplazamiento sobre el lado contra-lateral de la incisión. En general y a menos que no sea descrito de otra forma, la mayor parte de la estructura del separador achaflanado (120) es similar o comparable a la estructura de los implantes (10), (40), (50) y (80). Por consiguiente, la discusión de los componentes similares no se ha estimado necesaria. Los pasajes del primer lado lateral (18) a los lados anterior y posterior (26), (28) tienen lugar por los bordes redondeados (30). Además el separador (120) no tiene dientes. La ausencia de dientes y el borde redondeado (30) permiten al separador (20) deslizarse entre la placa extrema y en el espacio evacuado (de un anillo lateral al otro), hasta el lado contra-lateral. El primer lado lateral (18) es el lado que debe de favorecer el movimiento del separador (120). Después de que el espaciador (120) ha sido situado contra el lado contra-lateral con la única incisión utilizando un instrumento quirúrgico para empujar el separador (120), un material de injerto óseo u otro material osteo-conductor es situado en el espacio discal. Finalmente, el implante (no importa que implante 10, 40, 50, 70 ó 70' pueden ser utilizados), es implantado en el lado proximal de la incisión.
Aun cuando es aparente que las formas de realización ilustrativas de la invención divulgadas aquí cumplimentan los objetivos mencionados anteriormente, será de apreciar que numerosas modificaciones y otras formas de realización pueden ser concebidas por las personas expertas en la técnica. Por consiguiente, será evidente que el alcance de la presente invención esta únicamente limitado por las reivindicaciones adjuntas.

Claims (26)

1. Implante (10, 40, 50, 70, 80) comprendiendo una porción de hueso alógeno y teniendo una pluralidad de paredes laterales planas o curvas (18, 22, 26, 28), una superficie superior (14) y una superficie inferior (16) con el fin de ajustarse como un injerto entre las superficies del hueso o de los fragmentos de
huesos adyacentes,
caracterizado porque
A) las dichas superficies superior e inferior (14, 16) están provistas de una estructura en tres dimensiones para interconectarse con dichas superficies de hueso o de fragmentos de hueso adyacentes, y por-
que
B) dicho implante (10, 40, 50, 70, 80) esta combinado con un separador discreto (120) comprendiendo una porción de tejido óseo alógeno conformada en tamaño y forma con una parte de una placa vertebral y teniendo un perfil en forma acuñada, en el cual las superficies superior e inferior (14, 16) de dicho separador (120) son sensiblemente lisas y el pasaje entre las superficies superior e inferior y los lados anterior (26) y laterales (18, 22) del separador tiene lugar por los bordes curvos (30) para facilitar la implantación del separador (120).
2. Implante de acuerdo con la Reivindicación 1, caracterizado porque el implante (10, 40, 50, 70, 80) tiene un perfil en forma acuñada.
3. Implante de acuerdo con las Reivindicaciones 1 ó 2, caracterizado porque al menos una pared lateral (18, 22, 26, 28) tiene un canal (20) para recibir un instrumento quirúrgico.
4. Implante de acuerdo con la Reivindicación 1, caracterizado porque el canal (20) se desplaza en una dirección antero-posterior.
5. Implante de acuerdo con una de las Reivindicaciones 1 a 4, caracterizado porque la estructura en tres dimensiones comprende una pluralidad de dientes (12).
6. Implante de acuerdo con la Reivindicación 5, caracterizado porque los dientes (12) tienen una forma piramidal.
7. Implante de acuerdo con la Reivindicación 6, caracterizado porque los dientes (12) tienen una forma de dientes de sierra.
8. Implante de acuerdo con una de las Reivindicaciones 1 a 7, caracterizado porque al menos una de las paredes laterales (18, 22, 26, 28) del implante (10, 40, 50, 70, 80) tiene al menos un orificio (24) para la fijación de un aplicador.
9. Implante de acuerdo con la 8, caracterizado porque el dicho al menos un orificio (24) esta fileteado.
10. Implante de acuerdo con las Reivindicaciones 8 a 9, caracterizado porque el dicho al menos un orificio (24) esta previsto de un lado anterior, posterior, posterior-lateral o lateral.
11. Implante de acuerdo con una de las Reivindicaciones 1 a 10, caracterizado porque las superficies superior e inferior (14, 16) están definidas por unas superficies planas lisas.
12. Implante de acuerdo con una de las Reivindicaciones 1 a 11, caracterizado porque una región entre las superficies superior e inferior (14, 16) y un lado anterior del implante es un borde curvo (30) para facilitar la implantación del implante.
13. Implante de acuerdo con una de las Reivindicaciones 1 a 12, caracterizado porque el mismo es un implante intervertebral (10, 40, 50, 70, 80).
14. Implante de acuerdo con la Reivindicación 13, caracterizado porque las superficies superior e inferior (14, 16) son definidas por unas superficies curvas.
15. Implante de acuerdo con una de las Reivindicaciones 1 a 15, caracterizado porque el implante (10, 40, 50, 70, 80) tiene un espacio inferior (72) para recibir el material osteoconductor.
16. Implante de acuerdo con una de las Reivindicaciones 1 a 15, caracterizado porque el implante (10, 40, 50, 70, 80) esta dividido en dos partes, una parte superior (52) teniendo una superficie de conexión superior (56) y una parte inferior (54) teniendo una superficie de conexión inferior (58) acoplándose la superficie de conexión superior (56) con la parte de conexión inferior (58) cuando las partes superior es inferior (52, 54) están unidas.
17. Implante de acuerdo con la Reivindicación 16, caracterizado porque las superficies de conexión superior e inferior (56, 58) están provistas con nervios (60) y con ranuras (62) que se acoplan las unas con las otras con vistas a interconectar las partes superior e inferior (52, 54).
18. Implante de acuerdo con las Reivindicaciones 16 ó 17, caracterizado porque un pasador (64) es insertado por un orificio (66) en la parte superior (52) y por un orificio (66) en la parte inferior (54) para fijar juntas las partes superior e inferior (52, 54).
19. Implante de acuerdo con la Reivindicación 18, caracterizado porque el pasador (64) esta hecho de hueso alógeno.
20. Implante de acuerdo con una de las Reivindicaciones 1 a 19, caracterizado porque el mismo esta dividido en una primera y en una segunda parte (70, 70') teniendo cada una un lado medial (18) con un borde escalonado de forma que cuando las dos partes (70, 70') son implantadas con sus lados mediales (18) enfrentados entre sí, los bordes escalonados de dichos lados mediales (18) de dichas dos partes (70, 70') definen un espacio cilíndrico (72).
21. Implante de acuerdo con la Reivindicación 20, caracterizado porque la primera parte (70') esta provista de un pasador de enclavamiento (74) sobre el lado medial (18) y la segunda parte (70) esta
provista de una abertura (76) sobre el lado medial (18) configurada y dimensionada para recibir el pasador de enclavamiento (74) para mantener la relación espacial entre dichas dos partes (70, 70').
22. Implante de acuerdo con la Reivindicación 21, caracterizado porque el pasador de enclavamiento (74) es en hueso alógeno.
23. Implante de acuerdo con una de las Reivindicaciones 1 a 22, caracterizado porque el implante (10, 40, 50, 70, 80) tiene una longitud entre 6 - 15 mm.
24. Implante de acuerdo con una de las Reivindicaciones 1 a 23, caracterizado porque el implante (10, 40, 50, 70, 80) tiene una longitud entre 15 - 30 mm.
25. Implante de acuerdo con una de las Reivindicaciones 1 a 24, caracterizado porque el implante (10, 40, 50, 70, 80) tiene una longitud entre 4 - 30 mm.
26. Implante de acuerdo con una de las Reivindicaciones 1 a 25, caracterizado porque el implante (80) esta hecho de una pluralidad de secciones (82, 84, 86) de interconexión, teniendo cada una de dichas secciones (82, 84, 86) una superficie acoplándose
con una superficie de la sección de interconexión adyacente.
ES99940102T 1998-08-03 1999-07-30 Separador de injerto intervertebral. Expired - Lifetime ES2217796T3 (es)

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US09/814,214 US7087082B2 (en) 1998-08-03 2001-03-22 Bone implants with central chambers

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DE69916280D1 (de) 2004-05-13
US6258125B1 (en) 2001-07-10
EP1100417B1 (en) 2004-04-07
US7300465B2 (en) 2007-11-27
CA2338881A1 (en) 2000-02-17
US20050261771A1 (en) 2005-11-24
DE69916280T2 (de) 2005-05-25
US20080046090A1 (en) 2008-02-21
US20020062153A1 (en) 2002-05-23
US6554863B2 (en) 2003-04-29
ATE263526T1 (de) 2004-04-15
EP1100417A1 (en) 2001-05-23
US20050256574A1 (en) 2005-11-17
PT1100417E (pt) 2004-08-31
WO2000007527A1 (en) 2000-02-17
US7347873B2 (en) 2008-03-25
HK1036747A1 (en) 2002-01-18
CA2338881C (en) 2005-03-15
DK1100417T3 (da) 2004-08-02

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