ES2703216T3 - Conjunto de tornillo espinal de ángulo variable - Google Patents

Conjunto de tornillo espinal de ángulo variable Download PDF

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ES2703216T3
ES2703216T3 ES04734306T ES04734306T ES2703216T3 ES 2703216 T3 ES2703216 T3 ES 2703216T3 ES 04734306 T ES04734306 T ES 04734306T ES 04734306 T ES04734306 T ES 04734306T ES 2703216 T3 ES2703216 T3 ES 2703216T3
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body member
screw
rod
assembly
bushing
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Thomas Purcell
Don Hair
Tamas Frech
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Alphatec Manufacturing Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/7037—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/7038—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other to a different extent in different directions, e.g. within one plane only
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7032—Screws or hooks with U-shaped head or back through which longitudinal rods pass

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Neurology (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Un conjunto de tornillo espinal de ángulo variable (10) adaptado para fijarse a una vértebra que comprende un miembro de cuerpo (14, 114, 214) que define una pared lateral en general cilíndrica (34) que tiene una abertura inferior (30) que se abre en una superficie interior curvilínea (26) dispuesta alrededor de la abertura inferior; incluyendo el miembro de cuerpo un par de ranuras paralelas opuestas (32) adaptadas para recibir una varilla de fijación (19) entre las mismas; un tornillo (12, 112, 212) que tiene un árbol roscado y una parte de cabeza superior sustancialmente esférica (20, 210, 220); cargándose la parte de cabeza superior en el interior del miembro de cuerpo y extendiéndose el árbol a través de la abertura inferior con el fin de permitir un movimiento angular variable del tornillo con respecto al miembro de cuerpo durante el montaje; estando el montaje caracterizado por que el conjunto incluye: un buje ranurado circular (16) localizado en el miembro de cuerpo (14, 114, 214) y en contacto con la parte de cabeza superior (20, 210, 220) del tornillo (12, 112, 212) antes de la inserción y la sujeción de la varilla de fijación (19) para proporcionar una estabilidad básica al conjunto (10); estando el buje configurado para proporcionar un accesorio de presión alrededor de la parte de cabeza superior del tornillo, de tal manera que el tornillo, el miembro de cuerpo y el buje no se muevan libremente antes de la inserción y la sujeción de la varilla de fijación.

Description

DESCRIPCIÓN
Conjunto de tomillo espinal de ángulo variable
Antecedentes de la invención
La presente invención se refiere, en general, a un aparato para la fijación interior de la columna vertebral y, más específicamente a un conjunto de tornillo espinal de ángulo variable que facilita la implantación, un amplio intervalo de movimiento, facilidad de desmontaje para el ajuste o reemplazo de la varilla de estabilización y elimina los acoplamientos roscados convencionales y la rosca cruzada, el apriete y otros problemas asociados con los mismos. Ciertas afecciones de la columna vertebral, que incluyen una fractura de una vértebra y una hernia de disco, indican un tratamiento por inmovilización de la columna. Se conocen varios métodos de inmovilización de la articulación de columna vertebral, incluida la fusión quirúrgica y la unión de clavos y placas óseas a las vértebras afectadas. Un dispositivo conocido es un anclaje de interfaz ósea que se inserta en al menos dos vértebras separadas, con una varilla de estabilización que interconecta los dos o más anclajes para estabilizar las vértebras extendidas por los anclajes. Específicamente, se recibe un tornillo para huesos dentro de un conector formado en el anclaje. El anclaje incluye además un canal, que se extiende perpendicular al eje longitudinal del tornillo para huesos, para recibir la varilla de estabilización. El anclaje comprende además una parte roscada por encima del canal. Después de que el tornillo para huesos y el anclaje se hayan insertado en el material óseo, la varilla se coloca dentro del canal y una tuerca se acopla con las roscas exteriores del anclaje. La tuerca aplica una fuerza de compresión entre la varilla y la cabeza de tornillo para fijar firmemente la varilla entre las vértebras extendidas y estabilizar de este modo las vértebras de la columna vertebral.
Durante la implantación quirúrgica de estos sistemas de estabilización de la técnica anterior, la zona quirúrgica está llena de masas de tejido, esponjas y otros instrumentos quirúrgicos que obstruyen el acceso a las roscas de anclaje. Dado el difícil acceso, es posible que el cirujano realice una rosca cruzada de la tuerca con las roscas del anclaje una vez que la varilla de fijación esté en su lugar. Si las roscas del anclaje son de rosca cruzada, el acoplamiento de rosca cruzada debe retirarse y reemplazarse antes de que la cirugía pueda continuar. Además, el elemento de sujeción roscado (por ejemplo, la tuerca) se retira con frecuencia y a continuación se vuelve a instalar a medida que el cirujano realiza curvas progresivas para contornear la varilla de fijación. Esto aumenta la cirugía con cada iteración de encendido apagado y aumenta aún más las posibilidades de roscas cruzadas.
Otro problema asociado con las uniones roscadas es el par de torsión ejercido en el anclaje durante el apriete del elemento de fijación roscado sobre la parte de extremo superior del dispositivo de fijación. Este par de torsión puede introducir inadvertidamente puntos de tensión a lo largo de la varilla, doblar la varilla o incluso aflojar el acoplamiento roscado del anclaje en el hueso.
El ángulo en el que los tornillos de anclaje se extienden desde el pedículo de vértebra está dictado por la curvatura de la columna, la orientación de la vértebra individual dentro de la columna vertebral, y la colocación del cirujano del tornillo dentro del pedículo. Por ejemplo, hay una curvatura de columna vertebral considerable en la región de la unión vertebral S1-L5 y el ángulo entre el eje longitudinal de los tornillos y la vértebra en esa región varía en un amplio intervalo. Además, puede ser necesario desplazar uno o más de los anclajes de la línea media de rotación para efectuar la estabilización de columna vertebral máxima.
Por lo tanto, los canales de recepción de varilla son normalmente no colineales ni coplanares y, la varilla debe conformarse o contornearse por el cirujano durante el procedimiento de implantación para ajustarse dentro de los canales a lo largo de la columna vertebral. Los sistemas de la técnica anterior permiten que la unidad de acoplamiento gire con respecto al tornillo en un intervalo de aproximadamente 20 a 30, proporcionando algo de margen para que el cirujano coloque la varilla dentro del canal.
Uno de los desafíos con los sistemas de ángulo variable o poliaxiales actuales es alinear las unidades de acoplamiento de una manera que minimice el contorno de la varilla de preinserción al tiempo que permite al cirujano el intervalo máximo para optimizar la colocación del tornillo pedicular. Esto es especialmente difícil cuando se fusiona la unión S1-L5. Las unidades de acoplamiento de la técnica anterior permiten solo un intervalo limitado de movimiento con respecto a la cabeza de tornillo.
El documento EP 1190678A desvela un conjunto para la fijación ortopédica en el que un miembro superior tiene una ranura abierta para recibir una varilla y una tapa de cierre de bloqueo por torsión para fijar la varilla.
El documento US 2002/143341 y el documento US 2002/0082602 desvelan también un elemento de anclaje para una varilla y que comprende una parte de receptor que tiene unos brazos para recibir la varilla entre los mismos. La parte del receptor también tiene un orificio para recibir la cabeza esférica de un miembro de tornillo y la disposición tiene otros medios para unir firmemente la varilla y el miembro de tornillo.
El documento FR 2796545 A desvela un conector multiaxial que tiene un conector que tiene un asiento para recibir una varilla y un asiento deformable para recibir la cabeza de un anclaje de hueso.
Sumario de la invención
De acuerdo con un aspecto de la invención, se proporciona un conjunto de tomillo espinal de ángulo variable como en la reivindicación 1.
Las realizaciones preferidas se proporcionan en las reivindicaciones dependientes.
Las realizaciones pueden proporcionar un conjunto de tornillo espinal de ángulo variable para proporcionar una sujeción ajustable de una varilla de estabilización entre al menos dos vértebras separadas para efectuar la fijación interior de la columna vertebral a través de la vértebra afectada. El conjunto se usa con al menos otro conjunto de este tipo para fijar la varilla de fijación e incluye un tornillo pedicular, un miembro de cuerpo y una tapa de bloqueo. El tornillo pedicular tiene una parte de cabeza sustancialmente esférica que define una ranura en la misma que se usa para introducir el tornillo en una vértebra. El miembro de cuerpo es en general de configuración cilíndrica y está adaptado para recibir la parte de cabeza del tornillo pedicular y trabajar junto con el mismo para definir una rótula modificada para permitir un movimiento angular variable del miembro de cuerpo con respecto al tornillo pedicular con la parte de árbol roscado del tornillo que se extiende a través de una abertura en el extremo interior del miembro de cuerpo (o extremo inferior como se ve desde la perspectiva mostrada en los dibujos). El miembro de cuerpo define adicionalmente un par de ranuras paralelas opuestas dispuestas axialmente en la pared lateral del mismo para recibir una parte de la varilla de fijación cilíndrica. Las paredes interiores de la parte superior del miembro de cuerpo están provistas de bordes dentados que definen una pluralidad de dientes de trinquete alineados axialmente. Los dientes de trinquete están adaptados para trabajar junto con los dientes de acoplamiento opuestos formados en la superficie exterior de una tapa de bloqueo, de tal manera que al presionar la tapa de bloqueo hacia abajo dentro del miembro de cuerpo del conjunto contra la varilla de fijación y la varilla contra la cabeza de tornillo pedicular, los dientes entrelazados mantendrán la tapa en su lugar y fijarán la varilla de fijación en su lugar dentro del conjunto. Al rotar la tapa de bloqueo con respecto al miembro de cuerpo, los dientes de trinquete se desacoplan, aliviando la presión de la tapa en la varilla de fijación y liberando de este modo la sujeción de la varilla.
Al proporcionar al miembro de cuerpo del conjunto con una superficie interior redondeada alrededor de la abertura inferior que se acopla con la superficie inferior redondeada de la cabeza de tornillo esférica y con las superficies exteriores cóncavas en la parte inferior del miembro de cuerpo alrededor de dicha abertura, la orientación angular del eje central del miembro de cuerpo en relación con el tornillo pedicular es muy variable, lo que proporciona un intervalo de extensión del movimiento para facilitar la instalación quirúrgica. A través del trabajo conjunto de los dientes de trinquete entrelazados en el miembro de cuerpo y la tapa de bloqueo, se facilita aún más la instalación y se evitan las desventajas de los elementos de sujeción roscados convencionales.
De acuerdo con la presente invención, se emplea un buje dentro del miembro de cuerpo para distribuir mejor las fuerzas longitudinales ejercidas sobre el tornillo pedicular. El buje puede tener una configuración en general cilíndrica, colocarse adyacente a la pared lateral interior del miembro de cuerpo y definir un asiento para la varilla de fijación y un faldón dependiente bifurcado que se apoya y se acopla con las partes de la cabeza del tornillo pedicular al empujarse contra el mismo mediante la tapa de bloqueo presionando hacia abajo sobre la varilla de fijación. Como resultado, la fuerza ejercida sobre el tornillo se distribuye alrededor de la cabeza del tornillo para mejorar la sujeción de bloqueo entre el tornillo y el miembro de cuerpo.
Además, al proporcionar una interfaz de enchavetado entre la cabeza de tornillo pedicular y el miembro de cuerpo, el tornillo pedicular puede insertarse en el hueso por el cirujano sin que estorbe el miembro de cuerpo. A continuación, el miembro de cuerpo puede alinearse con la cabeza del tornillo incrustado, deslizarse sobre y a lo largo de la cabeza de tornillo, reorientarse con el fin de acoplarse a la superficie inferior interior del miembro de cuerpo con la cabeza de tornillo para definir la rótula modificada descrita anteriormente y el ángulo variable resultante o la relación poliaxial. Puede proporcionarse una interfaz enchavetada mediante un acoplamiento roscado entre el extremo inferior del miembro de cuerpo y la cabeza de tornillo fijo, mediante el que puede atornillarse el miembro de cuerpo sobre y a lo largo de la cabeza del tornillo incrustado. Como alternativa, la abertura de cabeza de tornillo y de miembro de cuerpo pueden ser de múltiples lados y configurarse con el fin de permitir que el miembro de cuerpo se deslice a lo largo de la cabeza de tornillo solo cuando los dos componentes están en una alineación dada. Una vez que el miembro de cuerpo se desliza a lo largo de la cabeza y se hace rotar con el fin de desalinear los lados respectivos, el miembro de cuerpo se bloquea en la cabeza de tornillo y se forma la relación de acoplamiento de ángulo variable entre los mismos.
Breve descripción de los dibujos
La figura 1 es una vista en perspectiva del conjunto de tornillo espinal de ángulo variable de la presente invención.
La figura 2 es una vista en perspectiva de la parte de tornillo de hueso del conjunto de la presente invención.
Las figuras 3A y 3B son vistas en perspectiva del miembro de cuerpo del conjunto de la presente invención. La figura 4 es otra vista en perspectiva del miembro de cuerpo de la presente invención que muestra la superficie inferior del mismo.
La figura 5 es una vista en perspectiva del buje empleado en la presente invención.
Las figuras 6A y 6B son vistas en perspectiva de una primera realización de la tapa de la presente invención. La figura 7 es una segunda realización de la tapa de la presente invención.
La figura 8 es una vista lateral del conjunto de tornillo espinal de ángulo variable de la presente invención.
La figura 9A es una vista en sección tomada a lo largo de la línea A - A de la figura 8
La figura 9B es una vista en sección tomada a lo largo de la línea B - B de la figura 8.
La figura 10 es una vista en despiece de una forma modificada del tornillo pedicular y del miembro de cuerpo empleado en la presente invención.
La figura 11 es una vista en perspectiva del tornillo pedicular modificado y del miembro de cuerpo de la figura 10 mostrada en la posición adjunta antes de roscar el miembro de cuerpo a lo largo de la cabeza de tornillo para formar la relación de acoplamiento entre la parte inferior esférica de la cabeza de tornillo y la superficie inferior interior del miembro de cuerpo.
La figura 12 es una vista en perspectiva en despiece de otra forma modificada del tornillo pedicular y del miembro de cuerpo empleados en la presente invención.
La figura 13 es una vista lateral representativa de la realización del tornillo pedicular y del miembro de cuerpo mostrado en la figura 12 con el miembro de cuerpo en el tornillo en la posición de ángulo variable acoplamiento.
Descripción detallada de la realización preferida
Haciendo referencia ahora en detalle a los dibujos, el conjunto de tornillo espinal de ángulo variable 10 de la presente invención comprende un tornillo pedicular 12, un miembro de cuerpo 14, un buje 16 y una tapa de bloqueo 18. El conjunto 10 se usa con al menos otro conjunto de este tipo y una varilla de estabilización o fijación 19 para conectar los conjuntos y estabilizar las vértebras en las que se insertan los conjuntos. El tornillo 12 de pedículo empleado preferentemente en el conjunto 10 tiene una cabeza esférica 20 que define una ranura 22 en la misma usada para introducir el tornillo en el hueso. La superficie redondeada 24 definida por la parte inferior de la cabeza de tornillo 20 descansa sobre y se acopla con una superficie interior redondeada 26 formada en el extremo interior o inferior del miembro de cuerpo 14 del conjunto 10 con el fin de formar una rótula modificada que proporciona el movimiento angular variable deseado del miembro de cuerpo con respecto al tornillo pedicular incrustado. La parte de árbol roscado 28 del tornillo 12 se extiende desde el mismo a través de la abertura 30 en el extremo inferior del miembro de cuerpo 14.
El miembro de cuerpo 14 del conjunto 10 define además un par de ranuras paralelas opuestas 32 dispuestas axialmente en la pared lateral 34 del mismo, que terminan en sus extremos inferiores en superficies curvilíneas 36. Las dos ranuras 32 están dimensionadas para recibir la varilla de fijación como se muestra en los dibujos, con las paredes 35 que definen las ranuras, extendiéndose preferentemente hacia arriba más allá del punto medio de la varilla y pueden inclinarse ligeramente para proporcionar una fuerza de sujeción ligera sobre la varilla antes de fijar la varilla con la tapa de bloqueo 18. Por lo tanto, durante el montaje, el cirujano ejerce una fuerza ligera hacia abajo sobre la varilla, encajando la varilla en el canal transversal definido por las ranuras alineadas 32.
La superficie interior exterior o superior de las paredes laterales 34 del miembro de cuerpo 14 tienen ambas unos bordes dentados que sobresalen radialmente de las mismas que definen en su interior una pluralidad de dientes de trinquete alineados axialmente 38. La superficie inferior exterior 40 del miembro de cuerpo 14 tiene una superficie cóncava que se extiende hacia fuera separada 42 formada en la misma y un par de superficies cóncavas dispuestas perpendicularmente 44. Las superficies 42 y 44, junto con las superficies de acoplamiento 24 y 26 en la cabeza de tornillo y en el miembro de cuerpo del conjunto, proporcionan un intervalo extendido del movimiento del miembro de cuerpo 14 con respecto al tornillo pedicular 12. En una realización, el intervalo del movimiento es aproximadamente ±30° en todas las direcciones (según se mide desde el eje longitudinal del tornillo) y aproximadamente ±40° en la dirección inferior-superior, las superficies cóncavas hacia fuera (como se ve desde la cabeza de tornillo) proporcionan el intervalo de movimiento de ± 40°, para un intervalo de movimiento total de 80°. Este intervalo de movimiento extendido, en comparación con la técnica anterior, le permite al cirujano una libertad adicional para localizar los tornillos y facilita el proceso de montaje al reducir la necesidad de contornear una varilla.
Para fijar la varilla de fijación 19 dentro del miembro de cuerpo 14 del conjunto, se proporciona la tapa 18 de bloqueo. La tapa 18 define una parte superior 48, un par de partes de pata dependientes arqueadas opuestas 50 y un saliente dependiente centralmente dispuesto 52, equidistantemente separado de las partes de pata 50. El saliente central 52 define preferentemente una superficie inferior o fondo plano 54. Las partes de pata 50 de la tapa 18 tienen cada una de las mismas una pluralidad de bordes dentados que sobresalen radialmente formados en las mismas que definen una pluralidad de dientes de trinquete alineados axialmente 56 adaptados para acoplar los dientes 38 en las paredes laterales interiores opuestas 34 del miembro de cuerpo 14, como se describirá.
Se emplea un buje 16 dentro del miembro de cuerpo 14 del conjunto 10 de paredes laterales adyacentes 34 para distribuir mejor las fuerzas longitudinales ejercidas sobre el tornillo pedicular. El buje 16 define un par de superficies cóncavas opuestas formadas en el extremo superior de un faldón circular 62 con el fin de definir un asiento 64 para la varilla de fijación 19. La parte inferior del faldón del buje 62 está ranurado en 66 para proporcionar flexibilidad en la misma y define unas superficies de extremo ahusadas dependientes 68 adaptadas para apoyarse en los lados opuestos de la cabeza de tornillo redondeada 20. Un par de pestañas elásticas opuestas que sobresalen hacia fuera se proporcionan en los extremos superiores del buje 16 entre las superficies cóncavas 60 que están adaptadas para recibirse en un accesorio a presión dentro de un par de aberturas opuestas 72 formadas en la pared lateral 34 del miembro de cuerpo 14, tras lo cual el asiento de varilla 64 en el buje 16 se alinea con el canal en el miembro de cuerpo. Obsérvese que solo una de las aberturas 72 se ilustra en las figuras 3A y 3B para ilustrar mejor la configuración de los dientes de trinquete 38. En una realización alternativa, las pestañas podrían retirarse del buje 16 (como se ve en la figura 4) y localizarse en el miembro de cuerpo 14 para su acoplamiento con las aberturas u otros miembros de recepción formados en lados opuestos del buje.
Para proporcionar una estabilidad básica al sistema durante el montaje inicial, el buje 16 con su parte de faldón inferior ranurada está configurado para proporcionar un accesorio de prensión sobre la cabeza de tornillo 20 de tal manera que el tornillo pedicular 12, un miembro de cuerpo 14 y el buje 16 no se moverán libremente antes de la inserción y la sujeción de la varilla de fijación. Además, la parte superior del buje podría configurarse de tal manera que las superficies de pared 60 que definen el asiento de varilla 64 en el mismo se extiendan hacia arriba más allá del punto medio de la varilla y se inclinen ligeramente hacia el interior. Esto proporcionaría la misma fuerza ligera de sujeción cuando la varilla se empuja hacia el asiento de buje 64 que se ha descrito anteriormente haciendo referencia a las paredes de canal 35 en el miembro de cuerpo 14 del conjunto 10.
Tras la fijación del buje 16 en el elemento de cuerpo 14 y la varilla de fijación 12 en el asiento de buje 64, la tapa de bloqueo 18 se coloca de tal manera que las partes de pata dependientes 50 sobre la misma se alinean con las paredes laterales 34 del miembro de cuerpo 14. Al presionar la tapa 18 hacia abajo en el miembro de cuerpo 14, los dientes de trinquete 38 y 56 en el cuerpo del conjunto y la tapa se entrelazan con el fin de permitir que la tapa se presione hacia abajo pero no se retraiga. Cuando la tapa 18 se presiona hacia abajo en el miembro de cuerpo del conjunto, la superficie inferior plana 54 del saliente central 52 sobre la misma se apoya en la varilla de fijación 19 y presiona la varilla en y contra el asiento 64 formado en el extremo superior del buje 16. La presión resultante en el buje hace que las superficies ahusadas 68 en el extremo inferior del buje presionen contra la superficie redondeada de la cabeza de tornillo 20, fijando de este modo la varilla en el asiento 64 y proporcionando una fuerza descentralizada y uniformemente distribuida que actúa a lo largo del eje longitudinal del tornillo. Por lo tanto, el uso del buje 16 crea un bloqueo ahusado entre el tornillo pedicular y el miembro de cuerpo y aumenta el área de contacto entre los mismos. El resultado es una sujeción de bloqueo mejorada sobre la proporcionada por el contacto directo descrito anteriormente de la varilla de fijación contra el extremo superior de la cabeza de tornillo.
Los dientes de trinquete entrelazados permitirán al cirujano ejercer la fuerza de sujeción sobre la varilla de fijación presionando simplemente hacia abajo sobre la tapa de bloqueo 18. Los dientes sostendrán las partes de componente en su lugar. Para ajustar o retirar la varilla 19, se hace rotar la tapa de bloqueo 18 simplemente 90 grados alrededor de su eje longitudinal, con lo que los dientes 38 en las partes de pata dependientes 50 de la tapa se alinean con las ranuras abiertas 32 en el miembro de cuerpo 14, permitiendo que la tapa se separe hacia arriba de la varilla de fijación 19. Se proporciona una ranura 71 configurada hexagonalmente en la parte superior 48 de la tapa 18 para facilitar la rotación de la tapa de bloqueo con una herramienta de acoplamiento de tamaño adecuado.
Durante el funcionamiento, al menos dos de los tornillos pediculares 12 con los elementos de cuerpo 14 y los bujes adjuntos 16 dispuestos alrededor del tornillo se insertan en los pedículos de vértebra que abarcan la vértebra a fijar. El cirujano perfila de manera preliminar la varilla de fijación y verifica la alineación entre la varilla y los canales de acoplamiento formados por las ranuras en el buje y el miembro de cuerpo de los conjuntos. Ya que en general se requiere un perfilado adicional para mejorar la alineación, el cirujano ajusta de manera incremental la forma de la varilla y verifica el ajuste dentro de los canales hasta que la varilla encaje correctamente en todos los canales. Durante el proceso de perfilado, una tapa de bloqueo 18 puede acoplarse con uno o más de los miembros de cuerpo 14 (presionando la tapa axialmente en el miembro de cuerpo para crear el entrelazado entre los dientes de trinquete en el miembro de cuerpo y la tapa) para mantener temporalmente la varilla en su lugar, ayudando de este modo al cirujano a lograr un ajuste preciso. Las tapas de bloqueo pueden entonces quitarse fácilmente (haciendo rotar la tapa un cuarto de vuelta para desacoplar los dientes entrelazados), permitiendo que la varilla se perfile aún más. Una vez perfilada correctamente, la varilla se inserta en los canales y la tapa de bloqueo se presiona firmemente en cada miembro de cuerpo y el buje para fijar la varilla en su lugar. Para efectuar la sujeción de la varilla en cada uno de los conjuntos de tomillo pedicular, solo es necesario presionar la tapa de bloqueo longitudinalmente en el miembro de cuerpo de tal manera que la superficie inferior 54 del saliente central 52 en la tapa se presione contra la varilla de fijación 19, haciendo que la varilla presione hacia abajo contra el buje 16, que a su vez se acopla con y presiona contra la cabeza del tornillo pedicular.
Una forma modificada del conjunto de tornillo espinal de ángulo variable se ilustra en las figuras 10 y 11. Esta forma modificada del conjunto permite que el cirujano inserte el tornillo pedicular en el hueso, por sí mismo, sin que estorbe el miembro de cuerpo. En la realización anterior, el tornillo pedicular 12 debe insertarse a través del miembro de cuerpo 14 antes de que el tornillo pueda introducirse en el hueso. Con el miembro de cuerpo unido, la sujeción del tornillo en el hueso puede ser algo difícil. En el conjunto modificado 100, la superficie exterior de la parte de cabeza esférica 120 del tornillo pedicular 112 está provista de roscas 121, como se ve en la figura 10. Como en la realización anterior, el extremo superior de la parte de cabeza 120 está provisto de una ranura vertical 122 usada para introducir el tornillo en su lugar. La parte interior inferior 113 del elemento de cuerpo 114 a usar con el tornillo pedicular modificado 112 está provista de unas roscas 115 adaptadas para acoplar las roscas 121 en el tornillo. Como resultado, el miembro de cuerpo 114 puede enroscarse sobre (véase la figura 11) y a lo largo de la cabeza 120 del tornillo 112 después de que el tornillo se introduzca en su lugar. Con la excepción de las roscas 121 y 115, el tornillo pedicular 112 y el miembro de cuerpo 114 son idénticos en configuración al tornillo 12 y al miembro de cuerpo 14 de la realización anterior. De este modo, después de que el miembro de cuerpo 114 se enrosque sobre y a lo largo de la cabeza de tornillo y que se disponga dentro del interior del extremo inferior del miembro de cuerpo 114, como se ve en la figura 11, la relación angular variable entre los mismos se forma como en la realización anterior.
Una segunda forma modificada del conjunto de tornillo espinal de ángulo variable que permite al cirujano insertar el tornillo pedicular en el hueso, por sí mismo, sin que estorbe el miembro de cuerpo se ilustra en las figuras 12 y 13. Como se ve en la misma, las roscas de acoplamiento en el tornillo pedicular 112 y en el miembro de cuerpo 114 se han reemplazado con superficies octagonales de acoplamiento. En este segundo conjunto modificado 200, la superficie exterior de la parte de cabeza esférica 220 del tornillo 212 está provista de una parte octagonal. La parte octagonal está compuesta por ocho superficies de contacto 221, una de las cuales (por ejemplo, la 221a) tiene una longitud desigual con respecto a las superficies restantes. La parte interior inferior 213 del miembro de cuerpo 214 a usar con el tornillo pedicular modificado 212 también está provista de una parte configurada octagonalmente adaptada para acoplarse con las superficies octagonales en la cabeza de tornillo. Debido a la inclusión de una superficie de diferente tamaño tanto en el tornillo como en el miembro de cuerpo, el tornillo pedicular 212 solo se alineará con el miembro de cuerpo 214 en una sola posición, es decir, donde la superficie de contacto acortada en la cabeza de tornillo se alinea con la superficie acortada correspondientemente en el interior inferior del miembro de cuerpo. En consecuencia, el tornillo pedicular 212 puede insertarse nuevamente en el hueso sin estar unido al miembro de cuerpo 214. Después de que el tornillo 212 se introduce en su lugar, el miembro de cuerpo 214 puede insertarse a lo largo de la cabeza de tornillo con las superficies octagonales alineadas con las superficies correspondientes en la cabeza de tornillo. Al presionar el cuerpo de tornillo hacia abajo, se inserta completamente en la cabeza de tornillo y las superficies octagonales de acoplamiento se mueven fuera de acoplamiento. Al rotar el miembro de cuerpo y tirar hacia arriba del miembro de cuerpo, de tal manera que la cabeza esté dispuesta dentro del interior del extremo inferior del miembro de cuerpo 214, la relación angular variable entre los mismos ilustrada en la figura 13 se forma como en las realizaciones anteriores. Debe entenderse que esta forma de la presente invención no se limita al uso de superficies octagonales de acoplamiento. Cualquier configuración poligonal podría emplearse en la cabeza de tornillo y en el miembro de cuerpo, en la que al menos una de las superficies de acoplamiento en la cabeza de tornillo y en el miembro de cuerpo se configura correspondientemente de tamaño diferente o de otra manera diferente de las superficies restantes en la cabeza de tornillo y en el miembro de cuerpo.
A diferencia de estas realizaciones de la invención, y de acuerdo con un ejemplo útil en explicar la presente invención, no se emplea el buje 16. Las ranuras axiales opuestas 32 en la pared lateral 34 del miembro de cuerpo del conjunto definen un asiento para la varilla de fijación 19. Cuando la tapa de bloqueo se presiona en el miembro de cuerpo con la varilla de fijación que se extiende a través de la misma, la superficie inferior plana 54 del saliente central 52 se apoya nuevamente en la varilla de fijación y, en este caso, presiona la varilla contra el extremo superior de la cabeza de tornillo pedicular. Para tales aplicaciones, el miembro de cuerpo y el tornillo pedicular deberían dimensionarse de tal manera que la superficie superior del tornillo sobresalga por encima de la parte inferior del asiento definido por las ranuras axialmente opuestas 32 con el fin de permitir que la varilla presione contra el tornillo y cree una sujeción rígida, pero ajustable, entre el miembro de cuerpo y el tornillo pedicular. Este ejemplo también puede utilizarse con las formas modificadas del tornillo pedicular 128 y el miembro de cuerpo 114 mostradas en las figuras 10 y 11. En todas estas realizaciones, los componentes del conjunto de tornillo espinal de ángulo variable están formados preferentemente de titanio.
Debería observarse que aunque la configuración preferida de la tapa de bloqueo proporciona un montaje redondeado y al ras en los extremos superiores del miembro de cuerpo 14 cuando la tapa de bloqueo se inserta completamente contra la varilla de fijación, podrían emplearse otras configuraciones de tapa de bloqueo. Por ejemplo, la figura 7 ilustra una tapa de bloqueo que tiene una parte perimetral en general cilíndrica en la que los dientes de trinquete 56 sobresalen radialmente a lo largo de las partes de pata 50. Esta configuración se ilustra en la figura 1. Como resultado, el extremo superior de la tapa de bloqueo estaría desplazado hacia dentro desde el extremo superior del miembro de cuerpo sin afectar adversamente el funcionamiento del conjunto de tomillo espinal de ángulo variable. Otros cambios y modificaciones diversas también podrían hacerse al realizar la presente invención.
Aunque la presente invención se ha descrito a modo de realizaciones a modo de ejemplo, debería entenderse que pueden realizarse muchos cambios y sustituciones por los expertos en la materia sin alejarse del alcance de la presente invención, que se define por las reivindicaciones adjuntas.

Claims (5)

REIVINDICACIONES
1. Un conjunto de tomillo espinal de ángulo variable (10) adaptado para fijarse a una vértebra que comprende un miembro de cuerpo (14, 114, 214) que define una pared lateral en general cilíndrica (34) que tiene una abertura inferior (30) que se abre en una superficie interior curvilínea (26) dispuesta alrededor de la abertura inferior; incluyendo el miembro de cuerpo un par de ranuras paralelas opuestas (32) adaptadas para recibir una varilla de fijación (19) entre las mismas; un tornillo (12, 112, 212) que tiene un árbol roscado y una parte de cabeza superior sustancialmente esférica (20, 210, 220); cargándose la parte de cabeza superior en el interior del miembro de cuerpo y extendiéndose el árbol a través de la abertura inferior con el fin de permitir un movimiento angular variable del tornillo con respecto al miembro de cuerpo durante el montaje; estando el montaje caracterizado por que el conjunto incluye:
un buje ranurado circular (16) localizado en el miembro de cuerpo (14, 114, 214) y en contacto con la parte de cabeza superior (20, 210, 220) del tornillo (12, 112, 212) antes de la inserción y la sujeción de la varilla de fijación (19) para proporcionar una estabilidad básica al conjunto (10); estando el buje configurado para proporcionar un accesorio de presión alrededor de la parte de cabeza superior del tornillo, de tal manera que el tornillo, el miembro de cuerpo y el buje no se muevan libremente antes de la inserción y la sujeción de la varilla de fijación.
2. El conjunto de la reivindicación 1, en el que el buje (16) comprende un par de superficies de pared cóncavas opuestas (60) formadas en un extremo superior del mismo con el fin de definir un asiento (64) para la varilla de fijación (19), y una parte inferior que define unas superficies de extremo ahusadas (68) adaptadas para apoyarse en lados opuestos de la parte de cabeza superior (20, 210, 220), en el que la presión de la varilla dentro y contra el asiento (64) hace que las superficies ahusadas (68) presionen contra la parte de cabeza de tornillo (20), fijando de este modo la varilla en el asiento (64) y proporcionando una fuerza descentralizada y distribuida uniformemente que actúa a lo largo de un eje longitudinal del tornillo.
3. El conjunto de la reivindicación 2, que incluye una tapa de bloqueo (18) que, cuando se une con el miembro de cuerpo (14, 114, 214) en una configuración completamente ensamblada alrededor de una varilla de fijación (19), se soporta contra la varilla de fijación que a su vez se soporta contra el asiento (64) del buje (16) para aplicar presión en la parte de cabeza superior (20, 210, 220) contra la superficie interior curvilínea (26) del miembro de cuerpo con el fin de fijar la posición angular del miembro de cuerpo con respecto al tornillo (12, 112, 212).
4. El conjunto de la reivindicación 2 o 3, en el que el par de superficies de pared cóncavas opuestas (60) definen el asiento de varilla (64) que se extiende hacia arriba más allá de un punto medio de la varilla de fijación (19) y están ligeramente inclinadas hacia el interior para proporcionar una fuerza de sujeción cuando la varilla se introduce en el asiento de varilla.
5. El conjunto de cualquier reivindicación anterior, en el que el miembro de cuerpo (14, 114, 214) tiene una primera pestaña sobresaliente y una abertura de recepción de pestaña (70, 72); teniendo el buje (16) una segunda pestaña sobresaliente y una abertura de recepción de pestaña (70, 72), de tal manera que cuando el buje se localiza dentro del miembro de cuerpo, la pestaña sobresaliente se acopla de manera flexible con la abertura de recepción de pestaña para mantener la alineación correcta del buje con el miembro de cuerpo.
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