ES2341641T3 - Un dispositivo de bolsa de malla porosa expansible y su uso para cirugia osea. - Google Patents

Un dispositivo de bolsa de malla porosa expansible y su uso para cirugia osea. Download PDF

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Publication number
ES2341641T3
ES2341641T3 ES01955877T ES01955877T ES2341641T3 ES 2341641 T3 ES2341641 T3 ES 2341641T3 ES 01955877 T ES01955877 T ES 01955877T ES 01955877 T ES01955877 T ES 01955877T ES 2341641 T3 ES2341641 T3 ES 2341641T3
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ES
Spain
Prior art keywords
bag
cavity
bone
vertebra
filling
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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
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ES01955877T
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English (en)
Inventor
Stephen D. Kuslich
Leon J. Grobler
Steven J. Wolfe
James W. Ahern
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.)
Spineology Group LLC
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Spineology Group LLC
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Application filed by Spineology Group LLC filed Critical Spineology Group LLC
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Abstract

Un sistema corrector de fractura por compresión vertebral que comprende: medios (14) para la creación de una cavidad (16) dentro de un hueso (10), una bolsa porosa expansible y una herramienta de relleno (20) construida para suministrar material de relleno óseo (19) a presión en la bolsa porosa; caracterizado por: los medios (14) para la creación de la cavidad (16) son un escariador dispuesto para formar una cavidad dentro de la vértebra (10); medios para la inserción de la bolsa porosa expansible (22) en la cavidad (16) dentro de la vértebra (10); y la herramienta (20) de relleno está dispuesta para inyectar el material de relleno óseo (19) a presión en la bolsa porosa (22), cuando está en su sitio en la cavidad (16) dentro de la vértebra, para expandir la bolsa porosa expansible (22) hacia los límites de la cavidad (16).

Description

Un dispositivo de bolsa de malla porosa expansible y su uso para cirugía ósea.
Esta invención se refiere a un sistema corrector de fractura por compresión vertebral.
Las patentes de los EE.UU. 5.549.679 y 5.571.189 para Kuslich describen un dispositivo y un método para la estabilización del segmento espinal con un implante expansible de tela porosa para su inserción en el interior de un disco escariado que se carga con material para facilitar la fusión ósea. En la presente invención, se usa una bolsa similar para tratar fracturas por compresión de la columna vertebral.
Las patentes de los EE.UU. 5.108.404 y 4.969.888 para Scholten y otros describen un sistema para la fijación de hueso osteoporótico mediante un globo inflable que compacta el hueso para formar una cavidad en la que se inyecta cemento óseo después de retirar el globo. La invención requiere el uso de fluoroscopia para observar la inyección y para ayudar a prevenir las fugas de cemento a través de fisuras en los huesos. Lamentablemente, tales fugas se sabe que ocurren a pesar de estas precauciones. Dado que una fuga puede provocar lesiones graves, incluyendo parálisis, es necesario un dispositivo y un método mejorados.
La patente de EE.UU. 5.972.015 para Scribner y otros describe un sistema de despliegue de un tubo catéter en el interior de la vértebra y la expansión de un globo no poroso configurado de manera especial ahí dentro para compactar el hueso poroso para formar una cavidad. La solución del documento 5.972.015 de Scribner utiliza un globo no poroso que se infla dentro del hueso para producir compresión. La cavidad así formada se puede llenar después con cemento óseo.
Desafortunadamente, la bolsa utilizada por Scribner puede romperse durante la expansión para compactar el hueso esponjoso debido a salientes cortantes que se encuentran dentro de la cavidad que se va a expandir, dando lugar a fugas del medio de inflado. Además, el llenado de la cavidad formada finalmente podría permitir la fuga de cemento óseo fuera de los huesos, contra los vasos o los nervios lo que puede provocar complicaciones no deseadas.
La presente invención consiste en una mejora de todos los sistemas anteriores y evita las complicaciones que pueden ocurrir con el sistema del documento de los EE.UU. 5.972.015.
De acuerdo con la invención, se proporciona un sistema corrector de fractura por compresión vertebral que comprende: medios para la creación de una cavidad dentro de un hueso; una bolsa porosa expansible; y una herramienta de relleno construida para suministrar material de relleno óseo a presión en la bolsa porosa, caracterizado porque: los medios para la creación de la cavidad son un escariador dispuesto para formar una cavidad dentro de una vértebra; medios para la inserción de la bolsa porosa expansible en la cavidad dentro de la vértebra; y la herramienta de relleno se dispone para inyectar el material de relleno óseo a presión en la bolsa porosa, cuando está en su lugar en la cavidad dentro de la vértebra, para expandir la bolsa porosa expansible hacia los límites de la cavidad.
Así, la invención permite un método para corregir las fracturas por compresión de la columna mediante el acceso en primer lugar y perforación en el tejido o hueso dañado y escariado de la zona dañada y/o enferma usando cualquiera de los procedimientos actualmente aceptados o se puede preparar la zona dañada al expandir una bolsa dentro del tejido dañado el hueso debe ser estabilizado.
El escariador puede ser cualquier escariador convencional. Ejemplos de escariadores se describen en la patente de EE.UU. nº. 5.015.255. Se conocen y se pueden utilizar otros ejemplos de escariadores. Después de que el hueso dañado o tejido ha sido eliminado por el escariador, se pueden insertar unos medios de reparación ósea en la cavidad así formada, a través de un catéter y una bolsa de tela expansible como se describe en las patentes de EE.UU. 5.549.679 y 5.571.189.
Una descripción detallada de la invención se describe a continuación en esta memoria con referencia específica hecha a los dibujos en los que:
La Fig. 1 es una vista en alzado lateral de la vértebra que está fracturada y necesita reparación;
La Fig. 2 es una vista lateral de la vértebra de la Fig. 1 que está siendo escariada con una herramienta de escariado desde la vía de acceso anterior;
La Fig. 3 es una vista superior de la vértebra de la Fig. 1 que muestra el escariador formando un par de cavidades dentro de la vértebra desde la vía de acceso anterior;
La Fig. 4 es una vista en alzado lateral de la vértebra de la Fig. 2 que muestra la colocación de una bolsa de tela expansible de la invención;
La Fig. 5 es una vista en alzado superior de la vértebra de la Fig. 3 que muestra la segunda de dos bolsas de tela expansibles de la invención que está siendo colocada;
La Fig. 6 es una vista lateral de la vértebra que está siendo escariada desde una vía de entrada posterior;
La Fig. 7 es una vista superior de la vértebra de la Fig. 6 con una bolsa en su lugar y una segunda cavidad que se está escariando;
La Fig. 8 es una vista en alzado lateral de la vértebra de la Fig. 6 con una bolsa de tela expansible de la invención en su sitio; y
La Fig. 9 es una vista superior de la vértebra de la Fig. 7 con una bolsa inflada y la segunda bolsa desinflada.
En la siguiente descripción detallada se utilizan números de referencia similares para describir elementos similares de las diferentes figuras.
La Fig. 1 muestra una vértebra típica 30 que tiene fracturas 12 por compresión, que está necesitada de reparación. Como se indicó anteriormente la parte dañada de la vértebra 10 es escariada. Por ejemplo, la Fig. 2 muestra un escariador 14 entrando en la vértebra 10 desde la parte anterior para hacer una abertura 15 y la cavidad 16. Alternativamente, se pueden formar varias cavidades 16 tal como se muestra en la Fig. 3.
En la Fig. 4 se ve un tubo de suministro o catéter 20 en el proceso de suministro de una bolsa de tela expansible 22 dentro de la vértebra 10 o en una cavidad 16 presente allí dentro. Una vez que la bolsa 22 se coloca dentro de la vértebra 10, la bolsa 22 puede ser inflada o expandida hacia los límites de la cavidad 16 formada así por medio de la inserción o la inyección de material de relleno 19 en el interior 21 de la bolsa 22.
La Fig. 5 muestra una única bolsa rellena 22 de tela expansible en su sitio con una segunda bolsa expansible que se está insertando y expandiendo dentro de la cavidad 16.
Las Figs. 6-9 ilustran un procedimiento en el que la abertura 15 y la cavidad 16 se crean por la parte posterior. Independientemente de la dirección a través de la que se opera la vértebra 10, en todas formas, la cavidad 16 que se forma se rellena después con material óseo de sustitución aceptable.
El material óseo de sustitución 19 puede ser uno o más de los siguientes, o cualquier material biocompatible que se considere que tiene la respuesta fisiológica deseada:
A)
Material óseo desmineralizado, injerto de hueso morselizado, cortical, esponjoso, o córtico-esponjoso, incluyendo autoinjerto, aloinjerto o el xenoinjerto.
B)
Cualquier sustituto de injerto óseo o combinación de sustitutos de injerto óseo, o combinaciones de injertos óseos y sustitutos de injerto óseos, o sustancias de inducción de hueso, incluyendo pero no limitado a: fosfatos tricalcio, sulfatos tricalcio, carbonatos tricalcio, hidroxiapatita, proteína ósea morfogénica, derivados óseos calcificados y/o descalcificados.
C)
cementos óseos, tales como cementos óseos cerámicos y de polimetilmetacrilato.
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El material de sustitución de hueso se inserta en la bolsa 22 a través de una aguja, un catéter 20 u otro tipo de herramienta de relleno. El material de sustitución de hueso expande la bolsa hacia los límites de la cavidad 16.
La bolsa 22 puede ser una bolsa de tela pequeña, aproximadamente de uno a cuatro centímetros de diámetro, siendo más o menos de forma esférica, aunque se pueden utilizar otras formas elípticas y otras formas geométricas. La bolsa es flexible y maleable antes de que su espacio interior 21 se rellene con el contenido que se describirá. El material de la bolsa 22 puede ser configurado para asumir la forma de la cavidad en la que se coloca la bolsa. Si bien en este estado inicial, la bolsa puede pasar, sin inflar, a través de un portal o tubo relativamente pequeño, quizás de aproximadamente tres milímetros a aproximadamente un cm de diámetro.
La bolsa 22, tal como se puede observar mejor en la figura 9, se construye de una manera especial y novedosa. La bolsa 22 puede ser construida de una tela 23. La tela 23 puede ser tejida, tramada, trenzada o moldeada con forma con una densidad que permita la entrada y la salida de fluidos y soluciones y permitirá el crecimiento interno y el crecimiento a través de vasos sanguíneos y tejido fibroso y trabecula ósea, pero la porosidad de la tela es lo suficientemente estrecha para retener las partículas pequeñas de material encerrado, tal como injerto óseo o sustituto de injerto óseo triturado, tales como hidroxiapatita u otros materiales biocompatibles osteoinductivos conocidos por promover la formación de hueso. La tela 23 define una pluralidad de poros 25. En general, los poros 25 de la tela 23 tendrá un diámetro de aproximadamente 0,25 mm o menos, a aproximadamente 5,0 mm. El tamaño se selecciona para permitir el crecimiento tisular a la vez que contiene el material compactado en la bolsa. Si se utiliza cemento óseo u otro material que no experimentará crecimiento óseo, los poros 25 pueden ser mucho más estrechos para evitar la salida de los medios desde dentro de la bolsa 22 afuera a la cavidad 16. Esto evita las fugas que podrían afectar a los nervios, vasos sanguíneos o similares si se les permite salir del hueso.
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Uno o más de los poros 25 puede ser usado como abertura 27 de relleno, en la que la tela 23 puede ser manipulada para ampliar un poro hasta un diámetro potencialmente superior a 5 mm pero no más de aproximadamente 1 cm. Preferentemente, la abertura 27 de llenado es de diámetro inferior a aproximadamente 5 mm. Este poro/abertura de llenado 27 es suficientemente amplio para permitir que un catéter, aguja, tubo de llenado u otro dispositivo inserten o inyecten material de relleno que pasa a través de la tela 23 y en el interior 21 de la bolsa 22, sin dañar la integridad de la bolsa 22.
Cuando la bolsa 22 está totalmente llena de material de relleno, la bolsa formará una forma de auto-retención que sustancialmente llena la cavidad 16. Una vez lo suficientemente repleta, la herramienta de relleno utilizada para colocar material de relleno en el interior 21 de la bolsa se retira de la abertura 27. Cuando la abertura 27 no es un poro 25, sino una abertura distinta y separada en la bolsa 22, la abertura 27 puede tener un diámetro fijado que requiere obturación tal como por ligado, fijación, soldadura, encolado o cualquier otro medio de cierre de la apertura 27 después de que la bolsa se haya llenado. Cuando la abertura 27 es un poro 25, tras la retirada del catéter o herramienta de relleno de la abertura 27 la tela 23 se contraerá para reducir el diámetro de la abertura 27 para ser substancialmente similar al de los otros poros.
El tamaño y la densidad de los poros determinan la facilidad o dificultad con que los materiales pueden pasar a través de la malla. Por ejemplo, unos poros muy pequeños (<0,5 mm) prohíben el paso de todas las partículas excepto las más pequeñas y los líquidos. El tamaño de poro y la densidad pueden ser controlados en el proceso de fabricación, de manera que el producto final estaría adaptado a las necesidades del cirujano. Por ejemplo, si se utilizara cemento óseo de metilmetacrilato, el tamaño de los poros tendría que ser muy pequeño, tal como aproximadamente menos de 0,5 mm a aproximadamente 1,0 mm, mientras que, cuando se utilizan injertos óseos o gránulos de cerámica biocompatibles, se puede permitir tamaño de poros que puede ir desde aproximadamente 1,0 mm a aproximadamente 5,0 mm o más. El hecho de que la tela 16 es adecuadamente porosa le permite restringir el flujo potencialmente peligroso del material de relleno fuera de los confines de la bolsa.
La tela es ligera, biocompatible, flexible y fácil de manejar, y tiene muy buena resistencia a la tracción, y así es improbable que se desgarre o desmenuce durante la inserción y el inflado. Cuando se infla el dispositivo, el dispositivo se expande hasta rellenar una cavidad 16 previamente excavada.
El uso del término "tela" en esta memoria se pretende que incluya la definición habitual de ese término y que incluya cualquier material que funcione como una tela, es decir, la "tela" de la invención debe tener una pluralidad de poros 25, a través de los que se permite el flujo de material y de líquido bajo las condiciones descritas, y la "tela" debe ser lo suficientemente flexible para permitir que sea aplastada e insertada en una abertura más pequeña que el tamaño de la bolsa inflada.
La bolsa 22 no tiene por qué ser tejida y puede ser moldeada o formada de otra manera como se conoce bien en la técnica. El material preferido puede proporcionar la capacidad de adaptar tasas de absorbencia biológica. Se puede utilizar cualquier material de tipo sutura utilizado médicamente para formar la bolsa 22. La bolsa puede estar formada por plástico o incluso de metal. En al menos una realización la bolsa 22 se forma utilizando una combinación de hilo reabsorbible y/o no reabsorbible. La bolsa 22 puede incluir una abertura de llenado 27 que puede ser un casquillo que puede ser un plástico, cerámica o metal bioabsorbible y/o no bioabsorbible. La apertura 27 también puede ser tal como hidroxiapatita o podría ser de plástico o de metal. La abertura 27 también puede ser caracterizada como un poro 25, en la que un poro 25 de la tela 23 se ha expandido para permitir que un catéter 20 u otro dispositivo de llenado pase al interior 21 de la bolsa 22. La bolsa 22, puede formarse a partir de un material sólido al que se añaden perforaciones. La bolsa 22 puede ser parcial o totalmente absorbible, metal, plástico, tejido, sólido, una película o un globo extruido.
El sistema de la presente invención puede ser utilizado para tratar una vértebra dañada 10, de acuerdo con los siguientes procedimientos descritos en las figuras 1-9:
Inicialmente, la vértebra 10 que necesita reparación se expone quirúrgicamente mediante la formación de al menos una cavidad 16. La cavidad o cavidades 16 se forman por escariado. El escariado puede conseguirse por diversos medios tales como el uso de un escariador 14, como se muestra por ejemplo en la patente de EE.UU. nº. 5.015.255. A continuación, la bolsa de malla sin expandir o Dispositivo de Bolsa de Tela Expansible (EFBD: Expandable Fabric Bag Device) 22 se inserta en la cavidad o cavidades a través de un catéter 20 o por otros medios. En algún momento, el material de relleno 19 está preparado para la inserción o la inyección en el EFBD 22. A continuación de la preparación del material de relleno 19, el material se inyecta o se inserta de otra manera en la bolsa 22 usando suficiente presión para llenar la bolsa 22 hasta su estado expandido, produciendo así rigidez y tensión dentro de la cavidad o cavidades 16 para alcanzar el grado de corrección requerido en virtud de las fracturas por compresión. Por último, la abertura de llenado 27 se cierra para impedir la salida de material de inflado 19.

Claims (1)

1. Un sistema corrector de fractura por compresión vertebral que comprende: medios (14) para la creación de una cavidad (16) dentro de un hueso (10), una bolsa porosa expansible y una herramienta de relleno (20) construida para suministrar material de relleno óseo (19) a presión en la bolsa porosa; caracterizado por: los medios (14) para la creación de la cavidad (16) son un escariador dispuesto para formar una cavidad dentro de la vértebra (10); medios para la inserción de la bolsa porosa expansible (22) en la cavidad (16) dentro de la vértebra (10); y la herramienta (20) de relleno está dispuesta para inyectar el material de relleno óseo (19) a presión en la bolsa porosa (22), cuando está en su sitio en la cavidad (16) dentro de la vértebra, para expandir la bolsa porosa expansible (22) hacia los límites de la cavidad (16).
ES01955877T 2000-07-21 2001-07-20 Un dispositivo de bolsa de malla porosa expansible y su uso para cirugia osea. Expired - Lifetime ES2341641T3 (es)

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US7226481B2 (en) 2007-06-05
US20040073308A1 (en) 2004-04-15
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US20140067066A1 (en) 2014-03-06
US9526621B2 (en) 2016-12-27
US20060149379A1 (en) 2006-07-06
US20020068974A1 (en) 2002-06-06

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