ES2556909T3 - Instrumental de cirugía ortopédica personalizado y específico para el paciente - Google Patents

Instrumental de cirugía ortopédica personalizado y específico para el paciente Download PDF

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ES2556909T3
ES2556909T3 ES08835726.4T ES08835726T ES2556909T3 ES 2556909 T3 ES2556909 T3 ES 2556909T3 ES 08835726 T ES08835726 T ES 08835726T ES 2556909 T3 ES2556909 T3 ES 2556909T3
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patient
femur
bone
personalized
contour
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Luke J. Aram
Alan Ashby
Daniel D. Auger
Richard Beech
Travis Bennett
Bryan Rose
Jeffrey R. Roose
Chris Aker
Janell Sheaks-Hoffman
Matthew D. Smith
Mark B. Lester
Joseph G. Wyss
Matt Rhodes
Eric Zajac
Laban Cook
Dimitri Sokolov
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DePuy Products Inc
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DePuy Products Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/14Surgical saws
    • A61B17/15Guides therefor
    • A61B17/154Guides therefor for preparing bone for knee prosthesis
    • A61B17/155Cutting femur
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/14Surgical saws
    • A61B17/15Guides therefor
    • A61B17/154Guides therefor for preparing bone for knee prosthesis
    • A61B17/157Cutting tibia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/16Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1764Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00526Methods of manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B2017/568Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor produced with shape and dimensions specific for an individual patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/108Computer aided selection or customisation of medical implants or cutting guides
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T409/00Gear cutting, milling, or planing
    • Y10T409/30Milling
    • Y10T409/30084Milling with regulation of operation by templet, card, or other replaceable information supply

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Dentistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Transplantation (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

Un instrumento ortopédico personalizado y específico para el paciente, que comprende una tabla de corte para el fémur personalizada y específica para el paciente (1400) que comprende: (i) un cuerpo anterior (1402) que tiene una superficie situada frente al hueso (1412) que tiene un contorno negativo -personalizado y específico para el paciente- configurado para alojar una parte de un lado anterior del fémur de un paciente que tiene un contorno positivo correspondiente; el cuerpo tiene una ranura de corte (1432) que sirve de guía para el filo de una sierra, y la ranura de corte se encuentra en el cuerpo anterior o en una guía de corte (1430) que está unida al cuerpo anterior y está fabricada a partir de un material diferente al del cuerpo; la ranura de corte está posicionada de manera que permita a un cirujano realizar un corte distal en el fémur de un paciente, (ii) una pestaña principal (1404) que sale del cuerpo y se prolonga hacia su parte posterior; la pestaña principal tiene una superficie situada frente al hueso (1140) que tiene un contorno negativo -personalizado y específico para el paciente- configurado para alojar una parte del extremo distal del fémur del paciente que tiene un contorno positivo correspondiente, (iii) un borde principal (1408) que se prolonga hacia arriba desde el extremo de la pestaña principal; el borde principal tiene una superficie situada frente al hueso (1472) que tiene un contorno negativo -personalizado y específico para el paciente- configurado para alojar una parte de un lado posterior del fémur de un paciente que tiene un contorno positivo correspondiente, y que se caracteriza por el hecho de que el instrumento incluye: (iv) una pestaña secundaria (1406) que sale del cuerpo y se prolonga hacia la parte posterior; la pestaña secundaria tiene una superficie situada frente al hueso (1442) que tiene un contorno negativo -personalizado y específico para el paciente- configurado para alojar una parte del extremo distal del fémur del paciente que tiene un contorno positivo correspondiente, de manera que la pestaña principal y la pestaña secundaria crean una abertura (1405) entre ellas, (v) un borde secundario (1410) que se prolonga hacia arriba desde el extremo de la pestaña secundaria; el borde tiene una superficie situada frente al hueso (1474) que tiene un contorno negativo -personalizado y específico para el paciente- configurado para alojar una parte del lado posterior del fémur del paciente que tiene un contorno positivo correspondiente, en los que el borde principal y el borde secundario (1408, 1410) tienen una ranura ciega (1484) que se prolonga lateralmente por el lado que está frente al hueso y que se encuentra en un plano transversal con respecto a la ranura de corte (118) del cuerpo anterior, de tal manera que las ranuras ciegas pueden alojar el extremo distal del filo de una sierra que se introduce a través de la ranura de corte del cuerpo anterior.

Description

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segmento intermedio/lateral en el modelo tridimensional del hueso pertinente del paciente. El segmento intermedio/lateral se define o, si no, se selecciona para que se prolongue desde un punto que se halla en la superficie intermedia del hueso del paciente hasta un punto que se halla en la superficie lateral del hueso del paciente. El punto de la superficie intermedia y el punto de la superficie lateral se seleccionan para definir básicamente la anchura local intermedia/lateral máxima del hueso del paciente. [0046] En el paso 64, se dispone un segmento anterior/posterior en el modelo tridimensional del hueso pertinente del paciente. El segmento anterior/posterior se define o, si no, se selecciona para que se prolongue desde un punto que se halla en la superficie anterior del hueso del paciente hasta un punto que se halla en la superficie posterior del hueso del paciente. El punto de la superficie anterior y el punto de la superficie posterior se seleccionan para definir básicamente la anchura local anterior/posterior máxima del hueso del paciente. [0047] El punto de referencia a partir del que se tomará la escala para el contorno de referencia se define en el paso 66 como el punto de intersección del segmento intermedio/lateral y el segmento anterior/posterior. Por ello, debe advertirse que el punto de superficie intermedio, el punto de superficie lateral, el punto de superficie anterior y el punto de superficie posterior se hallan en el mismo plano. Después de que el punto de referencia se establezca inicialmente en el paso 66, el punto de referencia se mueve o se desplaza hacia un extremo del hueso del paciente. Por ejemplo, cuando el hueso del paciente es un fémur, el punto de referencia se mueve hacia abajo hacia el extremo distal del fémur del paciente. De manera inversa, cuando el hueso del paciente es una tibia, el punto de referencia se mueve hacia arriba hacia el extremo proximal de la tibia del paciente. Por ejemplo, el punto de referencia se desplaza una distancia igual a aproximadamente la mitad de la longitud del segmento anterior/posterior, tal y como se establece en el paso 64. Sin embargo, el punto de referencia puede desplazarse otras distancias siempre que sean suficientes para equilibrar el contorno de referencia y el grosor del cartílago presente en el hueso del paciente. [0048] Una vez que la localización del punto de referencia se ha determinado en el paso 68, se aumenta la distancia entre el punto de referencia y cada punto que se halla en el contorno de referencia y que lo define parcialmente (paso 70). Para ello, en una realización particular, cada punto del contorno de referencia se aleja del punto de referencia basándose en el valor porcentual de la distancia original, definido entre el punto de referencia y el punto particular en el contorno de referencia. Por ejemplo, cada punto que se halla en el contorno de referencia, y lo define parcialmente, puede alejarse del punto de referencia una distancia igual al valor porcentual de la distancia original entre el punto de referencia y el punto particular. En una realización, el valor porcentual está en un rango que va aproximadamente del 5% al 30%. En una realización particular, el valor porcentual es aproximadamente del 10%. [0049] Haciendo referencia a las FIGS. 4 a 9, en otra realización se modifica la escala del contorno de referencia seleccionando manualmente un punto local “elevado” en el contorno de la superficie de la imagen tridimensional del hueso del paciente. Por ejemplo, cuando el hueso pertinente del paciente es una tibia, tal y como se ilustra en las FIGS. 4 a 6, el punto de referencia 90 se localiza inicialmente en el punto elevado de la meseta tibial del modelo tibial 92. Puede usarse cualquier lado de la meseta tibial. Una vez que el punto de referencia 90 se ha fijado inicialmente en el punto elevado de la meseta tibial, el punto de referencia 90 se desplaza al centro aproximado de la meseta tal y como se ilustra en la FIG. 5, de tal manera que el eje Z que define el punto de referencia es paralelo al eje mecánico del modelo tibial 92. Posteriormente, tal y como se ilustra en la FIG. 6, el punto de referencia se mueve en dirección distal una cantidad predeterminada. En una realización particular, el punto de referencia se mueve en dirección distal unos 20 milímetros, pero también pueden usarse otras distancias. Por ejemplo, la distancia en la que se desplaza el punto de referencia puede basarse en el valor del grosor del cartílago. [0050] De manera inversa, cuando el hueso pertinente del paciente es un fémur, tal y como se ilustra en las FIGS. 7 a 9, el punto de referencia 90 se localiza inicialmente en en el punto más distal del extremo distal del modelo femoral
94. Puede usarse cualquier cóndilo del modelo femoral 94. Una vez que el punto de referencia 90 se fija inicialmente en el punto más distal, el punto de referencia 90 se desplaza al centro aproximado del extremo distal del modelo femoral 94, tal y como se ilustra en la FIG. 8, de tal manera que el eje Z que define el punto de referencia 90 es paralelo al eje mecánico del modelo femoral 92. También se determina la anchura 96 anterior/posterior del extremo distal del modelo femoral 94. Posteriormente, tal y como se ilustra en la FIG. 9, el punto de referencia se mueve o desplaza una distancia 98 en una dirección proximal o superior. En una realización particular, el punto de referencia se mueve o desplaza en una dirección proximal o superior una distancia 98 igual a aproximadamente la mitad de la distancia 96. Por ello, debe advertirse que puede usarse una de las múltiples técnicas diferentes para fijar la localización del punto de referencia basándose, por ejemplo, en el tipo de hueso. [0051] Refiriéndonos de nuevo a la FIG. 2, una vez que se ha modificado la escala del contorno de referencia en el paso 46, los lados intermedios/laterales del contorno de referencia se ajustan en el paso 48. Para ello, se puede disminuir la distancia entre el punto de referencia y cada uno de los puntos que se hallan en el lado intermedio y el lado lateral -y los definen parcialmente-del contorno de referencia. Por ejemplo, la distancia entre el punto de referencia y los puntos en los lados intermedio y lateral del contorno de referencia escalado se reduce, de manera opcional, a la distancia original entre dichos puntos. Por ello, debe advertirse que el contorno de referencia se iguala o, si no, agranda con respecto a al lado anterior del hueso del paciente, y prácticamente se corresponde con los lados intermedios y laterales del hueso del paciente, o no está escalado con respecto a ellos. [0052] El contorno de referencia también puede ajustarse en el paso 48 en las zonas del hueso del paciente que tengan un grosor del cartílago más reducido. Estas zonas con un grosor del cartílago más reducido pueden determinarse basándose en la existencia de un contacto entre hueso y hueso detectado en una imagen médica, en una simulación o similares. Adicionalmente, el cirujano ortopédico puede proporcionar información relevante de dichas zonas basándose en su experiencia y conocimientos. Si se localizan una o más zonas con un grosor reducido del cartílago, se reducirá el contorno de referencia (esto es, se disminuirá su escala) correspondiente a dichas zonas
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del hueso del paciente. [0053] De forma adicional, se pueden identificar uno o más osteofitos (excrecencias óseas) en el hueso del paciente, y el contorno de referencia puede equilibrarse con dicha presencia de osteofitos. Al compensar la diferencia debida a dichos osteofitos, el contorno de referencia se corresponde más estrechamente con el contorno de la superficie del hueso del paciente. Además, un extremo distal (cuando el hueso del paciente es una tibia) o un extremo proximal (cuando el hueso del paciente es un peroné) del contorno de referencia se pueden ajustar para mejorar la correspondencia entre el contorno de referencia y el contorno de superficie del hueso. Por ejemplo, cuando el hueso del paciente es un fémur, el extremo superior del contorno de referencia escalado puede reducirse o, si no, puede acercarse al contorno de superficie del fémur del paciente en la zona localizada por encima de la línea de demarcación del cartílago señalada en el fémur del paciente. De manera inversa, cuando el hueso del paciente es una tibia, el extremo inferior del contorno de referencia escalado puede reducirse o, si no, puede acercarse al contorno de superficie de la tibia del paciente en la zona localizada por debajo de la línea de demarcación del cartílago señalada en la tibia del paciente. Por ello, debe advertirse que el contorno de referencia escalado se agranda inicialmente para igualarlo con el grosor del cartílago en el hueso del paciente. Después, se reducen algunas zonas del contorno de referencia escalado o, si no, se mueven a sus posiciones originales y/o hacia el punto de referencia en aquellas zonas en las que falta el cartílago, éste es reducido o no está presente de otra forma. [0054] Una vez que el contorno de referencia se ha escalado y ajustado en los pasos 46 y 48, la posición de la guía de corte se define en el paso 50. En particular, la posición de la guía de corte se define basándose en el ángulo que existe entre el eje mecánico del fémur del paciente y el eje mecánico de la tibia del paciente. El ángulo puede determinarse fijando un segmento o línea que vaya desde el extremo proximal del fémur del paciente hasta el extremo distal del fémur del paciente, y fijando un segundo segmento o línea que salga del tobillo del paciente y atraviese el extremo proximal de la tibia del paciente. El ángulo entre estos dos segmentos/líneas es igual al ángulo entre el eje mecánico del fémur y la tibia del paciente. Después, se determina la posición de la guía para cortar huesos basándose en el ángulo entre los ejes mecánicos del fémur y la tibia del paciente. Debe advertirse que la posición de la guía de corte define la posición y la orientación del plano de corte de la tabla de corte personalizada y específica para el paciente. Posteriormente, en el paso 52, se define un contorno o relieve negativo de la tabla de corte personalizada y específica para el paciente basándose en el contorno de referencia escalado y ajustado y en el ángulo entre el eje mecánico del fémur y la tibia. [0055] Volviendo a la FIG. 1, después de que el modelo del instrumento de cirugía ortopédica personalizado y específico para el paciente se haya generado en el paso 26, se da validez al modelo en el paso 28. Por ejemplo, se puede dar validez al modelo analizando el modelo renderizado junto con el modelo tridimensional de la anatomía del paciente para verificar la correlación de las guías de corte y los planos, las guías para la fresadora y los puntos para el taladro previstos, y/o similares. Adicionalmente, se puede dar validez al modelo transfiriendo o proporcionando de cualquier otra forma el modelo generado en el paso 26 al cirujano ortopédico para que lo revise. Por ejemplo, cuando el modelo es un modelo renderizado en tres dimensiones, el modelo y las imágenes tridimensionales del hueso (o huesos) pertinente(s) del paciente pueden ser enviados al cirujano para que los revise. Cuando el modelo es un prototipo físico, el modelo puede ser enviado al cirujano ortopédico para que le dé validez. [0056] Después de que se haya dado validez al modelo en el paso 28, el instrumento de cirugía ortopédica personalizado y específico para el paciente se fabrica en el paso 30. El instrumento de cirugía ortopédica personalizado y específico para el paciente puede fabricarse utilizando cualquier método y herramienta de fabricación adecuados. Adicionalmente, el instrumento de cirugía ortopédica personalizado y específico para el paciente puede fabricarse a partir de cualquier material adecuado como, por ejemplo, un material mecánico, un material plástico, o una combinación de ambos, dependiendo, por ejemplo, del uso previsto para el instrumento. Posteriormente, el instrumento ortopédico personalizado y específico para el paciente, ya faricado, es enviado o se transfiere de cualquier otra forma al cirujano ortopédico. El cirujano lleva a cabo la intervención de cirugía ortopédica en el paso 32 utilizando el instrumento de cirugía ortopédica personalizado y específico para el paciente. Tal y como se ha explicado previamente, puesto que el cirujano ortopédico no necesita determinar la localización correcta del instrumento de cirugía ortopédica intraoperatoriamente, lo cual requiere habitualmente que el cirujano tenga que hacer estimaciones en cierta medida, se reducen las conjeturas o suposiciones y las decisiones que el cirujano ortopédico debe tomar durante la operación. [0057] Refiriéndonos ahora a las FIGS. 10 a 12, el instrumento de cirugía ortopédica personalizado y específico para el paciente puede ser una tabla de corte para el fémur 100. La tabla de corte 100 está configurada para que se acople a un fémur 124 de un paciente tal y como se ilustra en la FIG. 12. La tabla de corte 100 incluye un cuerpo 102 configurado para que se una con el lado anterior del fémur 124. Dos pestañas 104, 106 se prolongan ortogonalmente desde el cuerpo 102 y están configuradas para rodear el extremo del fémur 124 tal y como se explica con más detalle más adelante. Cada una de las pestañas 104, 106 tiene un borde que se curva hacia adentro 108, 110, respectivamente, y que se corresponde con los cóndilos posteriores del fémur. La tabla de corte para el fémur 100 tiene una superficie en contacto con el hueso o dispuesta frente al mismo 112, y que se ubica en el interior del cuerpo 102, las pestañas 104, 106 y los bordes 108, 110. La superficie en contacto con el hueso 112 tiene un contorno negativo 114 configurado para acoger una parte del hueso del paciente que tiene un contorno que se corresponde con él. Tal y como se ha explicado previamente, el contorno negativo 114 de la superficie en contacto con el hueso 112 permite colocar la tabla de corte 100 sobre el hueso del paciente en una única y predeterminada localización y orientación. [0058] De manera opcional, la superficie en contacto con el hueso 112 de la tabla de corte 100 (así como cada superficie en contacto con el hueso analizada en relación con otras estructuras) puede ser o puede no ser un negativo exacto del modelo óseo tridimensional generado a partir de una imagen médica (ver paso 26 del algoritmo
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10 ilustrado y descrito previamente en relación con la FIG. 1). En su lugar, la superficie en contacto con el hueso puede tener una desviación respecto al modelo óseo para compensar el cartílago del paciente que puede aparecer o puede no aparecer en la imagen médica. Habitualmente, esta desviación varía desde aproximadamente 0,5 milímetros hasta aproximadamente 5 milímetros dependiendo de la localización, el género del paciente y el estado de la enfermedad de la articulación del paciente. Normalmente, el cartílago es más grueso en las zonas 112b, 112d y 112e. A menudo es fino o inexistente en las zonas 112a y 112c. Así, la tabla de corte para el fémur 100 incluye diversas desviaciones o rangos en su superficie en contacto con el hueso 112. [0059] La tabla de corte 100 incluye una plataforma 116 para las guías de corte que se alza sobre el cuerpo 102. La plataforma 116 para las guías de corte incluye una guía de corte 118 señalada. La plataforma 116 también incluye un par de clavijas de guía anteriores 120. Las pestañas 104, 106 tienen señaladas un par de clavijas de guía distales
121. De manera opcional, las clavijas de guía 118 pueden usarse como guías de taladro para fijar agujeros para clavijas de guía en el fémur 124 del paciente. Sin embargo, no es necesario utilizar clavijas de guía. Esto es, la tabla de corte 100 puede unirse con el fémur 124 del paciente mediante presión aplicada a través del cuerpo 102 y las pestañas 104, 106, tal y como se explica más adelante. [0060] En la práctica, la tabla de corte para el fémur 100 se une con el extremo 122 del fémur de un paciente 124, tal y como se ilustra en la FIG. 12. De nuevo, puesto que la superficie en contacto con el hueso 112 de la tabla de corte 100 tiene un contorno negativo 114, la tabla 100 puede unirse con el fémur 124 en una posición única y prevista con antelación. Cuando se une de este modo, las pestañas 104, 106 rodean el extremo distal 126 del fémur 124 y los bordes 110, 112 de las pestañas 104, 106 rodean el lado posterior del fémur 124. Adicionalmente, cuando la tabla 100 se acopla con el fémur del paciente 124, una parte del lado anterior del fémur 124 se aloja en el contorno negativo 112 del cuerpo 102, una parte del extremo distal 126 se aloja en el contorno negativo 112 de las pestañas 104, 106, y una parte del lado posterior del fémur 124 se aloja en el contorno negativo (si lo hubiere) de los bordes 110, 112. Por ello, las superficies anterior, distal y posterior del fémur 124 tienen el apoyo de la tabla de corte para el fémur 100. El cuerpo 102, las pestañas 140, 106 y los bordes 110, 112 de la tabla de corte para el fémur 100 trabajan conjuntamente para asegurar el instrumento 100 al fémur 124. Esto es, el cuerpo 102, las pestañas 140, 106 y los bordes 110, 112 aplican presión sobre el fémur 124 para sujetar la tabla 100. Sin embargo, varias clavijas de guía (no se muestra en la ilustración) pueden introducirse en las guías para clavijas 120, 121 y en el fémur 124 para asegurar la tabla de corte 100 al fémur 124. Es más, las guías para clavijas 120, 121 pueden usarse para hacer agujeros en el fémur 124 que sirven como referencias útiles para futuras acciones, como orientar una tabla de recortar (no se muestra) o un bloque de bisel (no se muestra). [0061] Después de que la tabla 100 se haya asegurado al fémur del paciente (124), el cirujano ortopédico puede utilizar la tabla de corte para el fémur para extirpar una cantidad de fémur 124 prevista previamente. Es decir, el corte en el hueso realizado con la guía de corte 118 se corresponde con el plano de corte determinado durante la fabricación de la tabla de corte 100 (ver paso 24 del algoritmo 10 descrito previamente en la FIG. 1). Debe advertirse que, puesto que la plataforma para las guías de corte 116 está por encima del cuerpo 102, se aumenta la profundidad de la guía de corte 118, lo que procura estabilidad al filo de la sierra para huesos ortopédica o a otros aparatos de corte utilizados. [0062] Refiriéndonos ahora a las FIGS. 13 a 15, el instrumento de cirugía ortopédica personalizado y específico para el paciente puede ser una tabla de corte para el fémur 1300. La tabla de corte 1300 está configurada para que se una a un fémur de un paciente de manera similar a la tabla de corte descrita previamente. La tabla de corte 1300 incluye un cuerpo 1302 configurado para unirse al lado anterior del fémur de un paciente y dos brazos o pestañas 1304, 1306 que salen del cuerpo 1302 en dirección trasera. Las pestañas 1304, 1306 están configuradas para rodear un extremo distal del fémur, tal y como se explica con más detalle más adelante. Cada pestaña 1304, 1306 tiene un borde 1308, 1310 que se curva hacia adentro o se extiende hacia arriba, respectivamente, lo que da apoyo a los cóndilos posteriores del fémur. La tabla de corte 1300 puede fabricarse a partir de cualquier material adecuado. Por ejemplo, la tabla de corte 1300 puede fabricarse con plástico o con un material de resina. Opcionalmente, la tabla de corte 1300 puede fabricarse con una resina fotocurable o una resina curada con láser. En una realización particular, la tabla de corte 1300 se fabrica con una resina Vero, que se puede adquirir comercialmente a través de Objet Geometries Ltd. de Rehovot (Israel), utilizando un proceso de fabricación para prototipos rápidos. Sin embargo, la tabla de corte 1300 puede fabricarse a partir de otros materiales. Por ejemplo, en otra realización particular, la tabla de corte 1300 se fabrica a partir de una resina de poliimida termoplástica, como la resina Ultem, que se puede adquirir a través de Saudi Basic Industries Corporation Innovative Plastics de Riad (Arabia Saudí). [0063] El cuerpo 1302 tiene una superficie en contacto con el hueso o situada frente a él 1312 y una superficie exterior 1314 opuesta a la superficie situada frente al hueso 1312. La superficie exterior 1314 tiene una depresión o zona hueca 1316, que indica al cirujano donde aplicar presión al cuerpo 1302 al acoplar la tabla de corte 1300 al fémur del paciente. Adicionalmente, pueden encontrarse varios agujeros para clavijas de guía o pasajes 1318 que atraviesan el cuerpo 1302 y que tienen un diámetro cuyo tamaño es adecuado para alojar las correspondientes clavijas de guía con el objetivo de asegurar la tabla 1300 al fémur del paciente. Opcionalmente, uno o más de los agujeros para clavijas de guía 1318 pueden ser oblicuos o formar un ángulo con respecto a los restantes agujeros para clavijas de guía 1318, con el objetivo de asegurar aún más la tabla 1300 al hueso del paciente. [0064] El cuerpo 1302 tiene una guía de corte modular 1320. Esto es, el cuerpo 1302 tiene una ranura receptora para guías de corte 1322 en la que se aloja la guía de corte 1320. Un pestillo 1324 u otro aparato de cierre asegura la guía de corte 1320 a la ranura receptora para guías de corte 1322. Por ello, una de las diferentes guías de corte 1320 que tiene una ranura para guías de corte 1326 dispuesta en varias posiciones alternativas puede unirse con el cuerpo 1302 para permitir que el cirujano determine de manera selectiva la cantidad de hueso del paciente que se extraerá durante la intervención para cortar el hueso. Por ejemplo, una guía de corte 1320 que tiene una ranura para
10
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[0081] La máquina fresadora 300 incluye un procesador 5304, un periférico de entrada 5306 y un molino o trituradora 5310. El procesador 5304 puede ser cualquier tipo de procesador incluyendo, por ejemplo, un circuito de procesamiento discreto (esto es, una variedad de aparatos de lógica), circuitos integrados para uso general y/o circuitos integrados para aplicaciones específicas (por ejemplo, ASICs). El periférico de entrada 5306 puede ser cualquier tipo de periférico de entrada configurado para aceptar un soporte multimedia portátil (no se muestra) como, por ejemplo, un CD, un disco de vídeo digital, un USB u otros. Así, el periférico de entrada 5306 puede ser cualquier tipo de periférico de serie, periférico paralelo, un puerto para unidades flash u otro puerto o periférico de datos capaz de comunicarse con el soporte multimedia portátil y almacenar datos en él. El procesador 5304 está intercomunicado con el periférico de entrada 5306 a través de varios enlaces 5308. Estos enlaces 5308 pueden ser cualquier tipo de enlaces de comunicación capaces de facilitar la comunicación entre el procesador y 5304 y el periférico de entrada 5306. Por ejemplo, los enlaces 5308 pueden ser varios tipos de cables, cables de fibra óptica, señales inalámbricas y/o similares. [0082] La máquina fresadora 5300 también tiene un molino 5310 que está intercomunicado con el procesador 5304 a través de varios enlaces o links de comunicación 5312. De manera similar a los enlaces 5308, los enlaces 5312 pueden ser cualquier tipo de enlaces capaces de facilitar la comunicación entre el procesador 5304 y el molino. Por ejemplo, los enlaces de comunicación 5312 pueden ser varios tipos de cables, cables de fibra óptica, señales inalámbricas y/o similares. El molino 5310 puede incluir cualquier tipo de molino y aparatos relacionados y circuitos capaces de fabricar un instrumento de cirugía ortopédica personalizado y específico para el paciente a partir de materiales adecuados como plástico o metal. [0083] En la práctica, el procesador 5304 está configurado para controlar el molino 5310 y fabricar el instrumento de cirugía ortopédica personalizado y específico para el paciente. El procesador 5304 puede configurarse para controlar el molino 5310 basándose en un algoritmo de un software que se recibe a través del periférico de entrada 5306. Por ejemplo, el algoritmo del software que el procesador 5304 ejecuta para comtrolar el molino 5310 puede cargarse a través de un CD o un USB, conectados al periférico o puerto de entrada. En algunas realizaciones, el algoritmo del software puede adquirirse a través de un comerciante o vendedor. Por ejemplo, volviendo a la FIG. 1, el modelo del instrumento de cirugía ortopédica personalizado y específico para el paciente generado en el paso 526 del algoritmo 510 puede ser un algoritmo de un software que pueda ser utilizado por la máquina fresadora 5300. El comerciante puede enviar o pasar el algoritmo del software al cirujano ortopédico para que lo descargue en la máquina fresadora 5300. Así, la máquina fresadora 5300 está configurada para fabricar el instrumento de cirugía ortopédica personalizado y específico para el paciente basándose en las instrucciones del algoritmo del software. De este modo, la fabricación del instrumento de cirugía ortopédica personalizado y específico para el paciente se lleva a cabo de manera local, mientras que el diseño del instrumento puede realizarse fuera del centro de salud 5302. [0084] Una manera de facilitar la fabricación remota del instrumento de cirugía ortopédica personalizado y específico para el paciente es utilizar una red de trabajo (como Internet). En este caso, el cirujano u otro sanitario solicitan un instrumento incluyendo datos relevantes para un paciente específico. La petición puede incluir datos e información como imágenes médicas que muestran huesos del paciente como el fémur y la tibia. Una máquina cliente 5314 relacionada con el cirujano u otro proveedor de servicios sanitarios (por ejemplo, situada en el centro de salud) podrá usarse para realizar la solicitud del instrumento al comerciante. [0085] El comerciante o vendedor puede tener un sistema para planes de diseño 5316. El sistema para planes de diseño 5316 puede recibir una solicitud para realizar un instrumento a través de la red utilizada por la máquina cliente 5314 situada, por ejemplo, en el centro de salud 5302, generar un plan de diseño que ha sido personalizado basándose en la información recibida junto con la solicitud y, a través de la red, proporcionar al centro de salud 5302 el plan de diseño personalizado. El sistema para planes de diseño 5316 puede incluir uno o más aparatos informáticos y softwares, middlewares y/o firmwares asociados, los cuales trabajan conjuntamente para llevar a cabo las personalizaciones de los planes de diseño. [0086] Una vez que el plan de diseño se ha enviado al centro de salud 5302, se transfiere a la máquina fresadora 5300. Después, la máquina fresadora 5300 utiliza el plan de diseño para fabricar el instrumento de cirugía ortopédica personalizado y específico para el paciente.
13

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ES15174404T Active ES2800031T3 (es) 2007-09-30 2008-09-29 Método para generar una instrumentación quirúrgica ortopédica específica para un paciente personalizada
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