ES2368125T3 - Endoprótesis bioerosionable con capas inorgánicas bioestables. - Google Patents
Endoprótesis bioerosionable con capas inorgánicas bioestables. Download PDFInfo
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- A—HUMAN NECESSITIES
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
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Abstract
Una cánula (10,30) que comprende una estructura subyacente bioerosionable (25,35), caracterizada por una capa delgada, bioestable (11,31) sobre la estructura subyacente bioerosionable (25,35), teniendo la capa bioestable un espesor en el rango de menos de 1000 mn, donde la capa bioestable es aproximadamente el 5% o menos del espesor de la pared.
Description
Endoprótesis bioerosionable con capas inorgánicas bioestables
Campo técnico
Esta invención se relaciona con dispositivos médicos, tales como endoprótesis, y métodos para hacer y utilizar las mismas.
Antecedentes
El cuerpo incluye diversas vías de paso que incluyen vasos sanguíneos tales como arterias, y otros pasos corporales. Estas vías de pasos algunas veces se ocluyen o debilitan. Por ejemplo, pueden ocluirse como consecuencia de un tumor, ser restringidas por placas o debilitadas por una aneurisma. Cuando esto ocurre, las vías de paso pueden abrirse
o reforzarse, o incluso reemplazarse, con una endoprótesis médica. Una endoprótesis es un implante artificial que se coloca típicamente en una vía de paso o paso en el cuerpo. Muchas endoprótesis son miembros tubulares, ejemplos de los cuales incluyen cánulas, injertos de cánula y cánulas cubiertas.
Muchas endoprótesis pueden administrarse dentro del cuerpo mediante un catéter. Típicamente el catéter soporta una forma de tamaño reducida o compactada de la endoprótesis a medida que es transportado a un sitio deseado en el cuerpo, por ejemplo, el sitio de debilitamiento u oclusión de un paso corporal. Al alcanzar el sitio deseado la endoprótesis se instala de tal manera que puede entrar en contacto con las paredes del paso.
Un método de instalación involucra expandir la endoprótesis. El mecanismo de expansión utilizado para instalar la endoprótesis puede incluir forzarla para que se expanda radialmente. Por ejemplo, la expansión puede alcanzarse con un catéter que porta un balón en conjunción con una endoprótesis expandible mediante el balón reducida en tamaño con respecto a su forma final en el cuerpo. El balón se infla para deformar y/o expandir la endoprótesis con el fin de fijarla en una posición predeterminada en contacto con la pared del paso. El balón luego puede desinflarse, y retirarse el catéter.
Cuando la endoprótesis avanza a través del cuerpo, su progreso puede ser monitorizado, por ejemplo, seguido de tal forma que la endoprótesis puede colocarse apropiadamente en el sitio de objetivo. Después de que la endoprótesis se coloca en el sitio objetivo, la endoprótesis puede motorizarse para determinar si ha sido colocada apropiadamente y/o está funcionando apropiadamente. Los métodos para seguimiento y motorización de un dispositivo medico incluyen fluoroscopía de rayos X e imágenes de resonancia magnética (MRI).
La EP 1 752 167 A2 divulga un implante médico reabsorbible que tiene un cuerpo al menos parcialmente de un material que se reabsorbe en el cuerpo del receptor.
La WO 01/80920 A2 divulga materiales bioabsorbibles con recubrimientos antimicrobianos o polvos que proveen un efecto antimicrobiano efectivo y sostenible.
La US 2004/039438 A1 divulga una cánula vascular o endoluminal para ser implantado en un vaso, conducto o tracto de un cuerpo humano para mantener un paso abierto en el sitio del implante. La pared lateral de la estructura tubular abierta en el extremo de la cánula es una capa de base de un metal biológicamente compatible con la sangre y los tejidos del cuerpo humano.
La US 2005/159805 A1 divulga un implante que puede ser conformado únicamente para potenciar su funcionalidad y que también puede ser recubierto con un sistema de recubrimiento que afecta su funcionalidad.
La US 6 245 104 B1 divulga un método para conformar un recubrimiento de óxido de iridio sobre una cánula metálica para alcanzar una unión firme de un recubrimiento biocompatible delgado del óxido de iridio de tal manera que el óxido de iridio se resiste a ser desalojado de la cánula por expansión del mismo en un vaso del cuerpo humano durante la implantación de la cánula.
Resumen
La presente invención está dirigida a una cánula como se define en la reivindicación 1.
Las reivindicaciones dependientes representan realizaciones ventajosas de la presente invención.
Las realizaciones pueden incluir una o más de las siguientes características. La capa bioestable de la cánula tiene una o más de las siguientes características: un espesor en promedio de aproximadamente 10 a 20 nm; un volumen promedio en el rango de aproximadamente 5000 a 20000 micrómetros cúbicos por milímetro cuadrado de área superficial de la cánula; incluye material cerámico; incluye uno o más óxidos metálicos; incluye uno o más de óxido de titanio, óxido de rutenio, u óxido de iridio; incluye una forma cristalina de óxido de titanio; incluye una pluralidad de nódulos de aproximadamente 15-20 nm en tamaño; está sobre superficie de la cánula, por ejemplo, una superficie interior, una superficie exterior o una pared lateral de la cánula; está cubierta, en totalidad o en parte, por una capa bioerosionable; y/o es una monocapa. En realizaciones, la estructura subyacente bioerosionable incluye uno o más materiales bioerosionables escogidos de uno o más de un metal bioerosionable, una aleación metálica bioerosionable o un no metal bioerosionable.
En realizaciones, la cánula incluye: una o más monocapas de un óxido metálico, un material orgánico, un material polimérico o un material biológico; y/o incluye adicionalmente al menos un agente terapéutico, por ejemplo, paclitaxel.
Realizaciones adicionales pueden incluir una o más de las siguientes características. La capa bioestable se forma mediante un proceso sol-gel. En realizaciones, el proceso para hacer la capa bioestable incluye: modificar una porción seleccionada de la superficie de la estructura subyacente con grupos hidroxilo; permitir que los grupos hidroxilo reaccionen con uno o más alcóxidos metálicos para formar una capa bioestable unida de forma covalente de uno o más de los alcóxidos metálicos; (opcionalmente) retirar el exceso de alcóxido metálico adsorbido; e hidrolizar la superficie enlazada de forma covalente de la capa bioestable. En realizaciones, el proceso para hacer tal cánula que tenga una capa bioestable y una estructura bioerosionable incluye: aplicar la capa bioestable sobre una superficie de un polímero sustancialmente tubular; exponer la capa bioestable a una temperatura suficientemente elevada para retirar el polímero tubular sin afectar sustancialmente la capa bioestable; y aplicar un polímero bioerosionable a la capa bioestable. En realizaciones, el proceso incluye adicionalmente aplicar una capa de polímero bioerosionable sobre al menos una porción de la capa de bioestable.
Realizaciones adicionales pueden incluir uno o más de los siguientes aspectos: al menos una porción de la cánula se degrada durante un periodo de tiempo dentro del organismo y libera el agente terapéutico, y/o la cánula se implanta en una vía de paso cardiovascular.
Una cánula erosionable o bioerosionable se refiere a un dispositivo, o a una porción del mismo, que exhibe una sustancial reducción de masa o densidad o transformación química, después que es introducida en un paciente, por ejemplo, un paciente humano. La reducción de masa puede ocurrir, por ejemplo, por disolución del material que forma el dispositivo, y/o fragmentación del dispositivo. La transformación química puede incluir oxidación/reducción, hidrólisis sustitución reacciones electroquímicas, reacciones de adición, u otras reacciones químicas del material del cual está hecho el dispositivo o una porción del mismo. La erosión puede ser el resultado de una interacción química y/o biológica del dispositivo con el ambiente del cuerpo, por ejemplo, el cuerpo mismo o fluidos corporales, en los cuales está implantado y/o la erosión puede dispararse aplicando una influencia iniciadora, tal como un reactivo químico o energía al dispositivo, por ejemplo, incrementando una rata de reacción. Por ejemplo, un dispositivo, o una porción del mismo, pueden formarse a partir de un metal activo, por ejemplo, Mg o Ca o una aleación de los mismos, y que pueden erosionarse por reacción con agua, produciendo el correspondiente óxido metálico y gas hidrógeno (una reacción redox). Por ejemplo, un dispositivo o una porción del mismo, pueden formarse a partir de un polímero erosionable o bioerosionable, o una aleación o mezcla erosionable o bioerosionable de polímeros que pueden erosionarse por hidrólisis con agua. La erosión se presenta hasta un grado deseable en un marco de tiempo que puede proveer un beneficio terapéutico. Por ejemplo, en realizaciones, el dispositivo exhibe una reducción sustancial de masa después de un periodo de tiempo después del cual no se necesita o es deseable una función del dispositivo, tal como soporte de la pared del paso o suministro de un fármaco. En realizaciones particulares, el dispositivo exhibe una reducción de masa de aproximadamente 10% o más, por ejemplo, aproximadamente 50% o más, después de un periodo de implantación de un día o más, por ejemplo, aproximadamente 60 días o más, aproximadamente 180 días o más, aproximadamente 600 días o más, o 1000 días o menos. En realizaciones, el dispositivo exhibe fragmentación por procesos de erosión. La fragmentación ocurre, por ejemplo, a medida que algunas regiones del dispositivo se erosionan más rápidamente que otras regiones. Las regiones de erosión más rápidas se debilitan más rápidamente erosionando a través del cuerpo de la endoprótesis y fragmentos de las regiones de erosión más lento. Las regiones de erosión más rápida y erosión más lenta pueden ser aleatorias o predefinidas. Por ejemplo, las regiones de erosión más rápida pueden predefinirse tratando las regiones para potenciar la reactividad química de las regiones. Alternativamente, las regiones pueden tratarse para reducir las ratas de erosión, por ejemplo, utilizando recubrimientos. En realizaciones, solo porciones del dispositivo exhiben erosionabilidad. Por ejemplo, una capa exterior o recubrimiento puede ser erosionable, mientras que una capa interior o cuerpo no es erosionable. En realizaciones, la endoprótesis se forma a partir de un material erosionable disperso dentro de un material no erosionable tal que después de la erosión, el dispositivo ha incrementado su porosidad por erosión del material erosionable.
Las ratas de erosión pueden medirse con un dispositivo de prueba suspendido en una corriente de solución de Ringer que fluye a una velocidad de 0.2m/segundo. Durante la prueba, todas las superficies del dispositivo de prueba pueden exponerse a la corriente. Para propósito de esta divulgación, la solución de Ringer es una solución de agua destilada recién hervida que contiene 8.6 gramos de cloruro de sodio, 0.3 gramos de cloruro de potasio y 0.33 gramos de cloruro de calcio por litro.
Los aspectos y/o realizaciones pueden tener una o más de las siguientes ventajas adicionales. La presencia de una capa bioestable en un dispositivo médico bioerosionable ofrece varias ventajas incluyendo una o más de: proveer un sustrato firme a una estructura de otra forma erosionable, facilitando así el crecimiento de células endoteliales y/o la unión mientras se retiene suficiente flexibilidad para facilitar la colocación y despliegue de la cánula; proveer una capa bioestable que ofrece una flexibilidad incrementada para hacer a la medida una superficie de cánula (por ejemplo hacer a la medida uno o más de: textura espesor, unión de grupo funcional y/o formación de cavidades tamaño molecular al retirar plantillas orgánicas o “impresiones moleculares”); y/o controlar la erosión (por ejemplo, bioerosión) de las endoprótesis protegiendo la estructura subyacente de la corrosión. Colocando una o más capas bioestables en localizaciones predeterminadas, la rata de erosión de las diferentes porciones de las endoprótesis puede controlarse. La liberación de un agente terapéutico desde las endoprótesis puede contralarse puesto que la rata de erosión está controlada. Además, la visibilidad de la endoprótesis, por ejemplo, endoprótesis biodegradable, frente a los métodos de imágenes, por ejemplo, rayos X y/o imágenes por resonancia magnética nuclear (MRI), puede potenciarse, aun después de que la endoprótesis se halla erosionada parcialmente, por ejemplo, incorporando un material radioopaco en la capa bioestable.
Otros aspectos, características y ventajas serán evidentes a partir de la descripción y dibujos, y a partir de las reivindicaciones.
DESCRIPCIÓN DE DIBUJOS
FIGS. 1A-1B son una vista en perspectiva y una vista en sección transversal a través de la pared de la
cánula, respectivamente, de una cánula.
FIGS. 2A-2D son vistas en sección transversal longitudinal que ilustran la colocación de una cánula en un
estado colapsado (figura 2A), expansión de la cánula (figura 2B), despliegue de la cánula (figura
2C) y degradación de la cánula (figura 2D).
FIGS. 3A-3B son vistas transversales de una pared de cánula antes y después de la erosión de una capa
erosionable, respectivamente.
FIGS. 4A-4B son una vista en perspectiva y una vista en sección transversal, respectivamente, de una cánula
texturizada.
FIGS 5 es una micrografía de microscopia electrónica de barrido (SEM) ve una cánula texturizada de
ejemplo.
FIGS 6 es un esquema general de la superficie del proceso sol-gel
FIGS 7A -7F son vistas en perspectiva y transversales de un proceso para hacer la cánula que tienen una
estructura subyacente bioestable y bioerosionable. Símbolos de referencia similares en diversos
dibujos indican elementos similares.
Descripción detallada
Con referencia a las FIGS. 1A-1B, la cánula 10 es generalmente un dispositivo tubular definido por una pared de cánula 21 que incluye fenestraciones 22 separadas por tirantes 23. Con referencia también a la figura 1B, una sección transversal a través de la pared de la cánula, una capa bioestable delgada continua 11 se provee en la parte exterior de una capa erosionable 25. En esta realización, la capa bioerosionable es erosionada por exposición a fluidos corporales desde el interior de la cánula, mientras que la capa bioestable proporciona una estructura firme para potenciar la endotelización y reducir el desalojamiento de fragmentos de la capa bioerosionable. Con referencias a las FIGS. 2A-2D, durante el uso, la cánula 10 se coloca sobre un balón 15 portado cerca del extremo distal de un catéter 14, y se dirige a través de un paso 16 (FIG. 2A) hasta que la porción que porta el balón y la cánula alcanzan la región de una oclusión
- 18.
- La cánula 10 se expande entonces radialmente inflando el balon15 y se presiona contra la pared del vaso con el resultado de que la solución 18 es comprimida (FIG.2B). La pared del vaso que rodea la cánula de 10 sufre una expansión radial (FIG. 2B). La presión se libera entonces desde el balón 15, y el catéter 14 es retirado del vaso (FIG. 2C). Con el tiempo, la estructura subyacente 25 de la cánula 10 se erosiona en el cuerpo, creando a veces fragmentos
- 19.
- La capa bioestable 11 permanece dejando una estructura firme para la endotelización de la pared del paso que envuelve la cánula, y hasta cierto grado, reduciendo la erosión y/o desalojamiento de los fragmentos (FIG. 2D).
Con referencia las FIGS. 3A y 3B en otra realización, la cánula 30 que tiene una capa bioestable no continua 31 sobre la parte superior de una estructura subyacente bioerosionable 35 se ilustra antes y después de la exposición a fluidos externos, respectivamente. La capa no continua 31 define una ventana 32 a través de la cual la estructura bioerosionable se expone al cuerpo desde el exterior de la cánula. Antes de la exposición a los fluidos corporales, la estructura subyacente bioerosionable 35 está sustancialmente intacta (FIG. 3A). con el tiempo, porción o porciones de la estructura subyacente 35 expuestas a los fluidos internos se erosionan a una rata más rápida que las áreas correspondientes cubiertas por la capa bioestable 31 creando así una estructura de cánula fragmentada diferencialmente (FIG. 3B).
La estructura de cánula subyacente puede incluir uno o más materiales bioerosionable escogidos de, por ejemplo, un metal bioerosionable, una aleación de metálica bioerosionable, o un no metal bioerosionable. En realizaciones particulares, la estructura de cánula tiene un grosor, rigidez y otras propiedades mecánicas globales suficientes para mantener la patencia de la región ocluida de un paso después de un procedimiento de angioplastia. A medida que la estructura erosionable se degrada con el tiempo, el espesor de la pared se reduce y se incrementa la flexibilidad de la cánula. La endotelización de la estructura erosionable puede ser inhibida típicamente por la erosión continua. La capa bioestable proporciona una superficie no erosionable en la cual puede presentarse el crecimiento celular. La capa bioestable es suficientemente flexible, por ejemplo, debido a su delgadez, de tal manera que no inhibe sustancialmente las propiedades mecánicas de la cánula necesarias para colocación y despliegue o para inhibir el movimiento natural del vaso sanguíneo. La capa bioestable también puede ser texturizada para potenciar la endotelización. La capa bioestable puede proveerse, y pueden formarse morfologías texturadas, por los procesos de baja temperatura, tales como procesos sol-gel.
En realizaciones particulares, el material bioestable es una cerámica y el material bioerosionable es un polímero. La capa bioestable constituye hasta aproximadamente el 5%, 1%, 0.5%, o 0.05% o menos del espesor de la pared de la cánula en el momento de la implantación. Típicamente, la delgadez relativa de la capa bioestable se ajusta de tal forma que la cánula retiene la flexibilidad necesaria para la colocación y despliegue de la cánula. La cánula típicamente retiene al menos aproximadamente 50%, 75%, 90% o más de la flexibilidad de una cánula idéntica en otros aspectos, pero sin la capa bioestable. La flexibilidad de la cánula puede medirse por técnicas conocidas en la técnica. Por ejemplo, la cánula puede expandirse en un tubo de ensayo de caucho de silicona con propiedades mecánicas similares a un vaso sanguíneo. Después de la expansión, puede medirse el cambio en flexibilidad del área del vaso cánulado doblando el vaso en una prueba de flexión en tres puntos. La prueba de flexión en tres puntos es conocida en la técnica como una manera de evaluar la rigidez de la cánula (o su recíproco la flexibilidad). Típicamente involucran determinar la pendiente de una curva de fuerza-desplazamiento midiendo la deflexión de la cánula cuando la cánula es asegurada en dos puntos extremos separados a una distancia predeterminado, por ejemplo, 20 mm de distancia, y aplicando una fuerza vertical o tracción a medio camino entre dos puntos extremos asegurado (por ejemplo, aplicando una fuerza a un gancho suspendido por un Instrón), lo cual proporciona al tercer punto de la prueba de flexión en tres puntos . La prueba de flexión en tres puntos se describe adicionalmente Ormiston, J. et al. (2000) Catherization and Cardiovascular Interventions 50:120-124. Alternativamente, la flexión de la cánula sobre el catéter de balón puede medirse, por ejemplo, llevando a cabo una prueba de vía. La prueba de vía es conocida en la técnica, y se describe, por ejemplo, en los parágrafos 47-53 de U.S. 2004-0210211.
Ejemplos de cerámicas incluyen óxidos metales, por ejemplo, óxidos que incluyen uno o más de óxido de titanio, óxido de rutenio u óxido de iridio. Por ejemplo, uno o más capas de óxido de titanio pueden ser utilizados debido a su buena biocompatibilidad e inducción de endotelización. El óxido de titanio puede utilizarse en forma cristalina o amorfa. Las formas cristalinas pueden potenciar la unión y/o crecimiento de células endoteliales. Los óxidos de titanio se discuten adicionalmente en Chen, J.Y., Wan, G.J. (2004) Surface & Coating Technology 186:270-276. El espesor de la capa bioestable puede variar según sea necesario, pero sustancialmente es delgado para proporcionar una estructura de cánula flexible para facilitar, por ejemplo, el despliegue de la cánula, a la vez que proporciona un sustrato sustancialmente firme para facilitar la endotelización. Típicamente, la capa bioestable 11 tiene un espesor en el rango de menos de 1000 nm, típicamente menos de 100 nm micrones, y aproximadamente 1 a 50 nm, más típicamente, aproximadamente de 10 a 20 nm. La capa bioestable puede tener un volumen con un promedio de volumen en el rango de aproximadamente 2000 a 30000, más típicamente 5000 a 20000 micrómetros cúbicos por milímetro cuadrado de área superficial de cánula. El volumen puede medirse, por ejemplo, indirectamente haciendo estadísticamente una medición lineal a lo largo de la superficie de la cánula utilizando, por ejemplo, microscopía de fuerza atómica (AFM), o un haz de iones enfocados para producir líneas entrecruzadas a lo largo. Alternativamente, la microscopía de barrido electrónico de emisión de campo (FSEM) puede utilizarse para examinar la topología de la superficie y/o el porcentaje de la superficie de la cánula que está cubierto con la capa bioestable. La capa bioestable 11 puede extenderse sobre una superficie completa de la cánula 10 (por ejemplo, una superficie interna o externa, o una pared lateral, o cualquier combinación de las mismas), o pueden cubrir una porción de la cánula (Por ejemplo, 25%, 50%, 75% de la longitud de la superficie de la cánula). La capa bioestable puede cubrir una o más de los superficies interior o exterior de la cánula y/o paredes laterales, dejando la superficie abluminal expuesta. En realizaciones, la superficie interior está recubierta. Pueden retirarse porciones seleccionadas de la capa bioestable según se desee utilizando, por ejemplo, un láser para controlar la rata y/o localización de la erosión. La cánula puede tener una, dos o más capas de materiales bioestables si se desea. En otras realizaciones, una o más capas de materiales bioestables pueden embeberse con un
o más materiales bioerosionables (por ejemplo, materiales orgánicos, poliméricos, biológicos o metálicos), formando así una estructura híbrida de capas múltiples.
La capa bioestable ofrece ventajas adicionales, tales como permitir la hechura a medida de la superficie de la cánula (por ejemplo, hechura a medida de uno o más de: textura, espesor, enlace de grupos funcionales y /o impresión molecular formando cavidades de tamaño de molécula por eliminación de plantillas orgánicas). Con referencia a las FIGS. 4A-4B, una vista en perspectiva de una cánula 40 que tiene una superficie texturizada 41, y una vista transversal de la región A de la FIG. 4A, respectivamente, la capa bioestable 45 puede tener una textura (también denominada aquí como "nanotextura") caracterizada por una pluralidad de nódulos 44 que facilita la migración y/o unión celular endotelial. Con Referencia a la FIG. 5, una micrografía con microscopio electrónico de barrido (SEM) de una vista superior de ejemplo a alta magnificación de una capa superficial texturizada de titania muestra una morfología de grano esférica de una pluralidad de nódulos alrededor de 15-20 nm en tamaño ( la barra de escala en la FIG. 5 corresponde a aproximadamente 70 nm). Las morfologías de superficie de las capas cerámicas se describen adicionalmente en Daoud, W. et al. (2005) Journal of Non-Crystalline Solids 351:1486-1490. El diámetro del nódulo es típicamente inferior a 100 nm, por ejemplo, menor de 50 nm, típicamente alrededor de 5 a 30 nm, más típicamente alrededor de 10 a 20 nm. La textura define espacios entre los nódulos de aproximadamente 50 a 500 nm, por ejemplo, alrededor de 200 nm, o aproximadamente el tamaño de una célula endotelial típica. Los recogimientos texturizados potencian el crecimiento y la migración tanto de músculos lisos como de células endoteliales. Con el fin de reducir el cubrimiento de los músculos lisos, la capa bioestable texturizada puede incluir un fármaco que inhiba preferencialmente el crecimiento celular del músculo lisos, por ejemplo, paclitaxel, maximizando por lo tanto el recubrimiento con células endoteliales de la cánula.
La capa bioestable puede formarse mediante procesos sol-gel. Los Procesos sol-gel, en particular, los proceso sol-gel a baja temperatura, son útiles para crear un recubrimiento de óxido metálico cristalino de sobre un sustrato (Daoud, W. et al. (2005) supra; Yun, Y-J et al. (2004) Materials Letters 58:3703-3706; Nishio, K. et al. (1999) Thin Solid Films 350:96-100; Wu, L. et al. (2005) Journal of Solid State Chemistry 178:321-328).En realizaciones, el óxido de metal se aplica al polímero. En otras realizaciones, el polímero se aplica al óxido de metal. Los procesos Sol-gel pueden formar recubrimientos delgados, sin un calentamiento excesivo que podría destruir el polímero u otros sustratos. Por ejemplo, pueden depositarse películas delgadas de dióxido de titanio cristalino (TiO2) sobre una cánula erosionable a temperaturas bajas utilizando un recubrimiento por goteo sol-gel. El sol de titanio puede prepararse, por ejemplo, a temperatura ambiente mezclando tetraisopropóxido de titania (TTIP) en soluciones acuosas ácidas y subsecuentemente se somete a reflujo a 80°C durante 8 horas para facilitar la formación de cristalitas de anatasa. Las películas de óxido de titanio depositadas pueden calentarse a 115°C. Pueden formarse superficies homogéneas de esferoides típicamente alrededor de 20 -60 nm de tamaño. Pueden prepararse una o más capas bioestable de óxido de iridio, por ejemplo, por un proceso de recubrimiento por goteo sol-gel donde se utiliza cloruro de iridio como material de partida. La solución de recubrimiento también puede prepararse haciendo reaccionar cloruro de iridio, etanol y ácido acético tal como se describe en Nishio, K. et al. (1999) supra. Los procesos Sol-solvo-térmicos pueden ser utilizados para formar dióxido de titanio nanocristalino mesoporoso con actividad fotocatalítica tal como se describe en Wu et al. (2005) supra. En realizaciones, la deposición de las capas bioestables se lleva a cabo a temperatura ambiente.
Un proceso de superficie de sol-gel que involucra una metodología capa por capa puede utilizarse para agregar una o más monocapas de óxidos metálicos, materiales orgánicos, poliméricos, y/o biológicos (por ejemplo, péptidos tales como péptidos RGD para promover el enlazamiento de las células endoteliales) (véase, por ejemplo, Kunitake, T., Lee, S-W. (2004) Analytica Chimica Acta 504:1-6). Con Referencia a la FIG. 6, un esquema general de proceso de superficie sol-gel muestra un sustrato sólido con grupos hidroxilo sobre su superficie, el cual se deja reaccionar con alcóxidos metálicos en solución para formar una superficie enlazada de forma covalente en monocapa del alcóxido metálico. El alcóxido adsorbido en exceso puede retirarse por enjuague. La monocapa de alcóxido quimiosorbida se hidroliza entonces para dar una superficie hidroxilada nueva. El espesor de la capa de óxido metálico puede ser tan delgado, aproximadamente de 1 nm. En realizaciones, los compuestos de polihidroxilo absorbidos sobre la superficie proporcionan grupos hidroxilo libres, y los alcóxidos metálicos se absorben subsecuentemente. El proceso puede repetirse tanto como se desee para formar una o más capas múltiples del mismo o diferentes materiales, por ejemplo, otros óxidos metálicos, materiales orgánicos (por ejemplo, grupos funcionales), materiales poliméricos y /o los materiales biológicos (por ejemplo, péptidos). La capa bioestable puede derivarse como se desee alterando las composiciones de las capas, creando así grupos funcionalizados y/o sitios de impresión molecular selectivos. Por ejemplo, los compuestos orgánicos de polihidróxilo (por ejemplo, ácidos carboxílicos) pueden incorporarse fácilmente sobre una superficie de una capa de óxido metálico. Por eliminación de la plantilla orgánica, se forman cavidades con tamaño de molécula imprimiendo una cavidad que refleja las características estructurales y enantioselectiva de la plantilla. La capa bioestable puede ser sometida a derivación adicional, por ejemplo, para incluir polímeros biodegradables para crear características de superficie que potencien la función de las células endoteliales. Por ejemplo, pueden utilizarse polímeros biodegradables, tales como ácido poliláctico y/o ácido poliglicólico (por ejemplo, poli (ácido láctico -glicólico) (PLGA)) como andamios para soporte de la unión de las células endoteliales. Se describen técnicas adecuadas en Miller, D. C. et al. (2004) Biomaterials 25:53-61. Puesto que la unión tanto de células de músculos lisos como endoteliales se incrementa típicamente utilizando PLGA, el polímero puede incluir opcionalmente un inhibidor de células de músculos lisos, tales como el paclitaxel.
La capa bioestable puede aplicarse a la cánula antes o después de agregar la estructura bioerosionable. Por ejemplo, la capa bioestable puede aplicarse a la cánula antes de formar la estructura bioerosionable. En esas realizaciones, las capas bioestables (por ejemplo, capa de cerámica) pueden exponerse a altas temperaturas antes de que se conecten a la estructura bioerosionable.
Con referencia a las figuras. 7A-7F, vistas en perspectiva y transversales de las etapas de recubrimiento que sufre la cánula 7A-7E (paneles superior e inferior, respectivamente), empezando desde la etapa 7A, un polímero sólido de forma tubular 50 (por ejemplo, un tubo hecho de nylon, poli (óxido de etileno), poliimina (PI)) que tiene una superficie sustancialmente suave se muestra aquí. Con Referencia a la FIG. 7B, puede formarse un patrón de cánulas 54 sobre el tubo de polímero 50, por ejemplo, escribiendo la forma de la cánula sobre el tubo de polímero 50 utilizando una pluma de tinta que contiene una solución espesa sol-gel. En otras realizaciones, puede utilizarse una solución metálica para escribir una capa metálica sobre el tubo de polímero. Las plumas de tinta son obtenibles comercialmente de Ohm Craft, Honeoye Falls, NY bajo la marca registrada MicroPen (R). Con referencia de nuevo a las FIGS 7B y 7C, aplicando condiciones de calentamiento de acuerdo con las especificaciones de la cerámica, un recubrimiento de óxido de titanio se convierte en un estado anatasa (por ejemplo, calentando el polímero a aproximadamente 500°C durante aproximadamente 6 horas) y el tubo de polímero se elimina, dando como resultado por lo tanto una película muy delgada bioestable (por ejemplo cerámica) en la forma de la cánula. La película bioestable 56 puede acoplarse entonces dentro de un tubo cilíndrico (no mostrado) con un diámetro interior del tamaño del diámetro interno deseado de la cánula final y un diámetro externo ligeramente más grande que la película bioestable 56 (por ejemplo cerámica). Con Referencia a la FIG. 7D, se deposita un polímero bioerosionable dentro del tubo cilíndrico, dando como resultado un tubo bioerosionable 58 con una capa 56 bioestable (por ejemplo, cerámica) que tiene una forma de cánula encastrada dentro de sí misma. Las porciones del tubo bioerosionable 58 pueden ser retiradas selectivamente, por
ejemplo, utilizando un láser excimer para extirpar el polímero, formando por lo tanto una película de cerámica recubierta 60 (por ejemplo, una película de cerámica 56 recubierta con una capa biodegradable 58). Con referencia de nuevo a la FIG 7D la eliminación puede hacerse, por ejemplo, apuntando el láser radialmente hacia el tubo bioerosionable 58 y enfocando el láser en un número de etapas hacia el cilindro completo a un nivel de fluencia que es suficientemente alto para extirpar el polímero, pero más bajo que el umbral de extirpación de la película 56 bioestable, por ejemplo, cerámica. El polímero biodegradable 58 adyacente a la película 56 bioestable, por ejemplo, cerámica, permanecerá sustancialmente intacto, puesto que está bajo la sombra de la película bioestable, por ejemplo, cerámica. Con Referencia a la figura. 7E, el polímero en medio puede ser extirpado, dando como resultado una cánula 60 hecha de un polímero biodegradable 58 con un capa externa 56 bioestable, por ejemplo, cerámica. Con Referencia a la figura. 7F, realizaciones adicionales (opcionalmente) incluyen aplicar (por ejemplo, por aspersión) a la cánula 60 de la FIG 7E, una o más capas de un polímero bioerosionable (por ejemplo, el mismo o diferente polímero bioerosionable que se usó para formar el tubo bioerosionable 58), de tal forma que se encastra la película 56 bioestable (por ejemplo, cerámica) (totalmente o una porción de la misma) dentro de una película polimérica bioerosionable delgada 58. En la realización mostrada en la FIG 7F, el mismo polímero bioerosionable se aplica a la cánula 60 como el usado en las FIGS 7D-7E. Se espera que el polímero bioerosionable se degrade en el cuerpo a una velocidad rápida, aunque se espera que reduzca la propensión de la capa de cerámica bioestable a separarse después de la expansión. Con referencia de nuevo a las FIGS 7A-7F, la capa bioestable, por ejemplo, cerámica, puede alterarse adicionalmente para potenciar el enlace entre las capas bioerosionable y bioestable. En realizaciones, puede formarse una pluralidad de indentaciones o marcas sobre el patrón de la cánula 54, utilizando, por ejemplo, un láser excimer. Tales indentaciones o marcas pueden crear pozos sobre el interior de la forma de cerámica una vez que ha tenido lugar la quema, potenciando así el enlace entre el polímero biodegradable y la capa bioestable, por ejemplo, cerámica.
En realizaciones, la capa bioestable puede ser utilizada para la protección frente a la corrosión cuando la estructura subyacente bioerosionable de la cánula es un metal bioerosionable, tal como el magnesio, hierro y níquel (Cheng, M et al (2004). Scripta Materilia 51:1041-1045, Atik, M. et al. (1995) Cerámica Internacional 21:403-406). Otros recubrimientos que pueden utilizarse para formar capas delgadas por sol-gel para protección frente a la corrosión incluyen dióxido de circonio (ZrO2), composiciones binarias de dióxido de titanio y dióxido de silicio (TiO2-SiO2) y óxido de aluminio y dióxido de silicio (Al2O3-SiO2) (Atik, M. et al. (1995) supra).
La cánula puede incluir adicionalmente uno o más materiales bioestables, además de una o más capas bioestables descritas arriba.
Ejemplos de materiales bioestable incluyen acero inoxidable, tantalio, niobio, platino, níquel-cromo, aleaciones cobalto-cromo, tales como Elgiloy (R) y Phynox (R), Nitinol (por ejemplo, 55% de níquel, 45% de titanio), y otras aleaciones basadas en titanio, incluyendo aleaciones níquel-titanio, materiales de aleación con termomemoria. Las cánulas que incluyen regiones bioestable y bioerosionable se describen, por ejemplo, en US 2006-0122694, titulado "Medical Devices and Methods of Making the Same." El material puede ser adecuado para su uso, por ejemplo, en una cánula expandible por balón, una cánula auto-expandible, o una combinación de ambos (véase, por ejemplo, la patente US N°. 5,366,504). Los componentes del dispositivo médico pueden manufacturarse, o puede obtenerse comercialmente. Los métodos para fabricar dispositivos médicos tales como cánulas se describen, por ejemplo, en la Patente US N° 5,780,807, y en la Publicación de Solicitud de Patente de US N° 2004-0,000,046-A1. Las cánulas también son disponibles, por ejemplo, de Boston Scientific Corporation, Natick, MA, EE.UU., y Maple Grove, MN, USA.
Los Materiales bioerosionables se describen, por ejemplo, en la patente U.S. N°. 6,287,332 de Bolz, la publicación de solicitud de Patentes U.S. N° 2002/0004060 A1 de U.S. Heublein; las patentes de EE.UU. Nos. 5,587,507 y 6,475,477 a Kohn et al. Ejemplos de metales bioerosionable incluyen metales alcalinos, metales alcalinotérreos (por ejemplo, magnesio), hierro, zinc y aluminio. Ejemplos de aleaciones de metálicas bioerosionable incluyen aleaciones de metales alcalinos, aleaciones de metales alcalinotérreos (por ejemplo, aleaciones de magnesio), aleaciones de hierro (por ejemplo, aleaciones que incluyen hierro y hasta siete por ciento de carbono), aleaciones de zinc, y aleaciones de aluminio. Ejemplos de no metales bioerosionable incluyen polímeros bioerosionables, tales como, por ejemplo, polianhídridos, poliortoésteres, poliláctidos, poliglicólidos, polisiloxanos, derivados de celulosa y mezclas o copolímeros de cualquiera de estos. Los Polímeros bioerosionable se divulgan en la solicitud de patente publicada de US. N° 2005/0010275, presentada el 10 de octubre 2003; la Solicitud de patente publicada de US. N° 2005/0216074, presentada el 05 de octubre, 2004; y la patente de US. N°. 6.720.402.
La cánula puede ser manufacturada, o la cánula de partida puede ser obtenida comercialmente. Los métodos para hacer cánulas se describen, por ejemplo, en la patente de US.N°. 5.780.807 y en la publicación de solicitud de Estados Unidos U.S. 2.004 a 0.000.046-A1. Las cánulas también son disponibles, por ejemplo, de Boston Scientific Corporation, Natick, MA, U.S.y Maple Grove, MN, U.S. La cánula puede formarse a partir de cualquier material biocompatible, por ejemplo, un metal o una aleación, tan como se describe aquí. El material biocompatible puede ser adecuado para uso en una cánula auto-expandible, una cánula expandible por balón, o ambas. Ejemplos de otros materiales que pueden ser utilizados para una cánula expandible por balón incluyen metales nobles, materiales radioopacos, acero inoxidable y aleaciones que incluyen el acero inoxidable y uno o más materiales radioopacos.
La cánula puede incluir adicionalmente al menos un agente terapéutico presente en la porción bioestable y/o bioerosionable de la cánula. Si el agente terapéutico se encuentra en la porción bioerosionable de la cánula (por
ejemplo, interesparcido a través de la misma o localizados en un sitio predeterminado), la liberación del agente terapéutico puede controlarse a medida que la porción erosionable de la cánula se erosiona. Los términos " agente terapéutico "," agente farmacéuticamente activo "," material farmacéuticamente activo "," ingrediente farmacéuticamente activo ", "fármaco" y otros términos relacionados pueden utilizarse de forma intercambiable aquí e incluyen, pero no se limitan, a moléculas orgánicas pequeñas, péptidos, oligopéptidos, proteínas, los ácidos nucleicos, oligonucleótidos, agentes terapéuticos genéticos, agentes terapéuticos no genéticos , vectores para liberación de agentes terapéuticos genéticos, células, y agentes terapéuticos identificados como candidatos para regímenes de tratamiento vascular, por ejemplo, como agentes que reducen o inhiben la restenosis. Por molécula orgánica pequeña se entiende una molécula orgánica que tiene 50 o menos átomos de carbono, y menos de 100 átomos diferentes a hidrógeno en total.
El agente terapéutico puede ser escogido a partir de uno o más, por ejemplo, un agente antitrombogénico, un agente antiproliferativo /antimitótico, un inhibidor de proliferación de células de músculos lisos, un antioxidante, un agente antiinflamatorio, un agente anestésico, un agente anticoagulante, un antibiótico o un agente que estimule el
crecimiento celular endotelial y/o la unión. Agentes terapéuticos de ejemplos incluyen, por ejemplo, agentes antitrombogénicos (por ejemplo, heparina); agentes antiproliferativos/antimitóticos (por ejemplo, paclitaxel, 5 fluorouracil, cisplatino, vinblastina, vincristina, inhibidores de la proliferación de células de músculos lisos (por ejemplo, anticuerpos monoclonales), e inhibidores de la timidina quinasa); antioxidantes; agentes antiinflamatorios (por ejemplo, dexametasona, prednisolona, corticosterona); agentes anestésicos (por ejemplo, lidocaína, bupivacaína y ropivacaína), anticoagulantes; antibióticos (por ejemplo, eritromicina, triclosan, cefalosporinas, y aminoglucósidos), agentes que estimulen el crecimiento celular endotelial y/o su unión. Los agentes terapéuticos pueden ser no iónicos, o pueden ser aniónicos y/o catiónicos por naturaleza. Los agentes terapéuticos pueden utilizarse de forma singular, o en combinación. Agentes terapéuticos preferidos incluyen inhibidores de de restenosis (por ejemplo, paclitaxel), agentes antiproliferativos (por ejemplo, cisplatina) y antibióticos (por ejemplo, eritromicina). Ejemplos adicionales de agentes terapéuticos se describen en la solicitud de patente publicación en U.S N° 2005/0216074.
Para potenciar la radioopacidad de una cánula, puede incorporarse un material radioopaco, tal como nanopartículas de oro en la endoprótesis, por ejemplo, en la capa bioestable o en el cuerpo de la cánula. Por ejemplo, las nanopartículas de oro pueden hacerse cargadas positivamente aplicando una capa externa de lisina a las nanopartículas, por ejemplo, tal como se describe en (“DNA Mediated Electrostatic Assembly of Gold Nanoparticles into Linear Arrays by a Simple Dropcoating Procedure"Murali Sastrya and Ashavani Kumar, Applied Physics Letters, Vol. 78, No. 19, 7 May 2001. Otros materiales radioopacos incluyen, por ejemplo, tantalio, platino, paladio, tungsteno, iridio y sus aleaciones.
Dependiendo de la aplicación especifica, las cánulas pueden tener un diámetro de entre, por ejemplo, 1 mm y 46 mm. En ciertas realizaciones, una cánula coronaria puede tener un diámetro expandido que va desde aproximadamente 2 mm hasta aproximadamente 6 mm. En algunas realizaciones, una cánula periférica puede tener un diámetro expandido que va desde aproximadamente 4 mm hasta aproximadamente 24 mm. En ciertas realizaciones, una cánula gastrointestinal y/o para urología puede tener un diámetro expandido que va desde aproximadamente 6 mm hasta aproximadamente 30 mm. En algunas realizaciones, una cánula para neurología puede tener un diámetro expandido que va desde aproximadamente 1 mm hasta aproximadamente 12 mm. Una cánula para aneurisma aórtico abdominal (AA) y una cánula para una aneurisma aórtico torácico (TAA) puede tener un diámetro que va desde aproximadamente 20 mm hasta aproximadamente 46 mm. Las cánulas también pueden ser preferiblemente bioerosionables, tales como una cánula para aneurisma aórtico abdominal bioerosionable (AA), o un injerto para vaso bioerosionable.
En algunas realizaciones, la cánula se utiliza para tratar temporalmente un sujeto sin permanecer de forma constante en el cuerpo del sujeto. Por ejemplo, en algunas realizaciones, el dispositivo médico puede ser utilizado durante un cierto periodo de tiempo (por ejemplo, para soportar un paso de un sujeto), y luego se desintegra después de ese periodo de tiempo. Los sujetos pueden ser sujetos mamíferos, tales como sujetos humanos (por ejemplo, un adulto o un niño). Ejemplos no limitantes de tejidos y órganos para tratamientos incluyen el corazón, sistema vascular coronario o periférico, pulmones, tráquea, esófago, cerebro, hígado, riñones, vejiga, uretra y uréteres, ojo, intestinos, estómago, colon, páncreas, ovario, próstata, tracto gastrointestinal, tracto biliar, tracto urinario, músculos fibrosos, músculos lisos, senos, cartílagos y huesos.
Claims (15)
- REIVINDICACIONES1. Una cánula (10,30) que comprende una estructura subyacente bioerosionable (25,35), caracterizada por una capa delgada, bioestable (11,31) sobre la estructura subyacente bioerosionable (25,35), teniendo la capa bioestable un espesor en el rango de menos de 1000 mn, donde la capa bioestable es aproximadamente el 5%o menos del espesor de la pared.
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- 2.
- La cánula de la reivindicación 1, donde la capa bioestable (11,31) tiene un espesor de menos de 100 mn.
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- 3.
- La cánula de la reivindicación 1, donde la capa bioestable (11,31) es aproximadamente de 1 a 50 nm.
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- 4.
- La cánula de la reivindicación 1, donde la capa bioestable (11,31) es aproximadamente 1 a 20 nm.
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- 5.
- La cánula de una de las reivindicaciones precedentes, donde la capa bioestable tiene un volumen promedio en el rango de aproximadamente 2000 a 30000 micrómetros cúbicos por milímetro cuadrado de aérea superficial de la cánula.
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- 6.
- La cánula de una de las reivindicaciones 1 a 4, donde la capa bioestable tiene un volumen promedio en el rango de aproximadamente 5000 a 20000 micrómetros cúbicos por milímetro cuadrado de área de superficie de la cánula.
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- 7.
- La cánula de las reivindicaciones precedentes, donde la estructura subyacente bioerosionable (25, 35) es una capa.
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- 8.
- La cánula de una de las reivindicaciones precedentes, donde la estructura subyacente bioerosionable (25,35) incluye uno o más materiales bioerosionable escogido de un metal bioerosionable, una aleación metálica bioerosionable o un no metal bioerosionable.
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- 9.
- La cánula de una las reivindicaciones precedentes, donde el material de la capa delgada bioestable (11,31) es una cerámica y el material de la estructura subyacente bioerosionable (25,35) es un polímero.
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- 10.
- La cánula de la reivindicación 9, donde la cerámica es un óxido metálico.
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- 11.
- La cánula de la reivindicación 10, donde es óxido metálico incluye uno o más de óxido de titanio, óxido de ruteno, u óxido de iridio.
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- 12.
- La cánula de una de las reivindicaciones precedentes, donde la capa bioestable es texturizada.
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- 13.
- La cánula de una de las reivindicaciones precedentes, donde la capa delgada, bioestable (31) es no continua definiendo una venta (32) a través de la cual la estructura bioerosionable (35) está expuesta al cuerpo desde el exterior de la cánula (30).
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- 14.
- La cánula de una de las reivindicaciones precedentes donde la capa bioestable se extiende sobre una superficie completa de la cánula.
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- 15.
- La cánula de una de las reivindicaciones precedentes, que incluyen adicionalmente al menos un agente terapéutico.
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-
2007
- 2007-09-14 ES ES10159664T patent/ES2368125T3/es active Active
- 2007-09-14 EP EP07842485A patent/EP2121068B1/en not_active Not-in-force
- 2007-09-14 ES ES07842485T patent/ES2357661T3/es active Active
- 2007-09-14 CA CA002663304A patent/CA2663304A1/en not_active Abandoned
- 2007-09-14 EP EP11174306A patent/EP2399616A1/en not_active Withdrawn
- 2007-09-14 EP EP10159664A patent/EP2210625B8/en not_active Not-in-force
- 2007-09-14 AT AT10159664T patent/ATE516827T1/de not_active IP Right Cessation
- 2007-09-14 JP JP2009528493A patent/JP2010503491A/ja active Pending
- 2007-09-14 AT AT07842485T patent/ATE490794T1/de not_active IP Right Cessation
- 2007-09-14 DE DE602007011114T patent/DE602007011114D1/de active Active
- 2007-09-14 WO PCT/US2007/078476 patent/WO2008034048A2/en active Application Filing
- 2007-09-14 US US11/855,542 patent/US8128689B2/en not_active Expired - Fee Related
-
2012
- 2012-02-14 US US13/372,692 patent/US20120150286A1/en not_active Abandoned
Also Published As
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DE602007011114D1 (de) | 2011-01-20 |
US20120150286A1 (en) | 2012-06-14 |
US8128689B2 (en) | 2012-03-06 |
JP2010503491A (ja) | 2010-02-04 |
CA2663304A1 (en) | 2008-03-20 |
ATE516827T1 (de) | 2011-08-15 |
WO2008034048A2 (en) | 2008-03-20 |
EP2121068B1 (en) | 2010-12-08 |
EP2210625A1 (en) | 2010-07-28 |
EP2399616A1 (en) | 2011-12-28 |
US20080071352A1 (en) | 2008-03-20 |
ES2357661T3 (es) | 2011-04-28 |
ATE490794T1 (de) | 2010-12-15 |
EP2210625B8 (en) | 2012-02-29 |
WO2008034048A3 (en) | 2009-03-19 |
EP2210625B1 (en) | 2011-07-20 |
EP2121068A2 (en) | 2009-11-25 |
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