ES2537088T3 - Tejido multicapa absorbible reforzado para su uso en dispositivos médicos y método de fabricación - Google Patents
Tejido multicapa absorbible reforzado para su uso en dispositivos médicos y método de fabricación Download PDFInfo
- Publication number
- ES2537088T3 ES2537088T3 ES05813103.8T ES05813103T ES2537088T3 ES 2537088 T3 ES2537088 T3 ES 2537088T3 ES 05813103 T ES05813103 T ES 05813103T ES 2537088 T3 ES2537088 T3 ES 2537088T3
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- Prior art keywords
- fabric
- spun
- absorbable
- multilayer
- tissue
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Abstract
Un tejido multicapa que comprende un primer tejido no hilado absorbible y un segundo tejido hilado o tricotado absorbible, caracterizado porque: el primer tejido no hilado absorbible comprende un copolímero de glicólido y láctido; el segundo tejido hilado o tricotado absorbible comprende celulosa oxidada regenerada; y el peso de dicho primer tejido no hilado absorbible es de 10% a 80% del peso total del tejido multicapa.
Description
DESCRIPCIÓN
Tejido multicapa absorbible reforzado para su uso en dispositivos médicos y método de fabricación.
Campo de la invención 5
La presente invención se refiere a un tejido multicapa absorbible reforzado que es útil en dispositivos médicos y su método de fabricación.
Antecedentes de la invención 10
Generalmente se conoce el uso de tejidos multicapa en relación con procedimientos médicos. Por ejemplo, se usan tejidos multicapa como almohadillas multiusos, apósitos, mallas quirúrgicas, incluyendo mallas para reparación de hernias, malla para prevención de adhesiones y mallas para refuerzo de tejidos, dispositivos para cierre de defectos y hemostatos. 15
USP 5.593.441 de Lichtenstein et al describe una prótesis compuesta que tiene preferentemente una lámina de malla de polipropileno que permite el crecimiento del tejido, tal como malla Marlex®. Esta referencia desvela que pueden utilizarse otros materiales quirúrgicos que son adecuados para refuerzo de tejidos y cierre de defectos, incluyendo malla absorbibles tales como una malla de poliglactina 910 (Vicryl®). La prótesis compuesta de 20 Lichtenstein et al también tiene una barrera de adhesión, preferentemente una lámina de elastómero de silicona. Esta referencia generalmente sugiere que puede usarse una barrear de adhesión absorbible de celulosa oxidada regenerada tal como Interceed® (TC7) (comercialmente disponible en Ethicon, Inc., en Somerville, Nueva Jersey) como la barrera de adhesión para producir una prótesis compuesta que tiene efectividad a corto plazo. La prótesis compuesta de Lichtenstein et al se describe para uso en el refuerzo y reparación de una pared muscular debilitada 25 mientras limita la incidencia de adhesiones post-operativas.
USP 5.686.090 de Schilder et al describe el uso de un vellón en combinación con una película no absorbible o absorbible para prevenir crecimientos no deseados en tejido adyacente y para reducir adhesiones. Schilder et al generalmente desvela que polipropileno, poliéster, poliglactina, polidioxanona o poliglecaprone 25 30 pueden usarse como el material de vellón o el material película. El término “vellón” como se usa en esta referencia se describe por su porosidad, que se describe por estar en el rango de 10 a 1000 l/(m2s) flujo de gas, medido con una presión de entrada de 200 Pa, una superficie de test de 50 cm2 y un grosor de test de 1 mm. El compuesto de Schilder et al generalmente se describe como un implante multicapa.
35
WO 91/08726 (Compañía Procter and Gamble) y US 5.026.589 (Schechtman) desvelan prendas sanitarias desechables que comprenden materiales para lámina superior y/o lámina trasera preparados a partir de polímeros basados en ácido glicólico, ácido láctico y mezclas de los mismos. También se proporcionan artículos sanitarios desechables que tienen núcleos absorbentes que comprenden celulosa oxidada.
40
EP 0 388 829 (Mitsui Petrochemical Industries, Ltd) desvela un tejido no hilado multicapa que comprende capas de tejido tricotado o hilado y capas de tejido no hilado puestas juntas, consistiendo dichas capas de tejido tricotado o hilado en multifilamentos de resina sintética orientados en al menos una dirección y con un módulo de elasticidad a la tracción de 20 GPa o más y una fuerza de tracción de 1,2 GPa o más y dichas capas de tejido no hilado consisten en fibras de resina sintética dispuestas aleatoriamente. 45
US 5.683.794 (Wadsworth) desvela una red compuesta no hilada multicapa particularmente útil como un sustituto para una red hilada tal como una red textil, que comprende una primera capa de material fibroso y una segunda capa de fibras con base de celulosa; la primera y segunda capa están térmicamente unidas sobre aproximadamente 5 a 75% del área de superficie de la red. 50
EP 1 462 122 (Ethicon, Inc.) se dirige a un apósito hemostático que utiliza un sustrato fibroso de tejido hecho de celulosa oxidada carboxílica y que contiene una primera superficie y una segunda superficie opuesta a la primera superficie, teniendo el tejido flexibilidad, fuerza y porosidad efectivas para su uso como un hemostato; y además tiene una matriz porosa y polimérica homogéneamente distribuida sobre la primera y segunda superficie y a 55 través del tejido, la matriz porosa y polimérica está hecha de polímero de celulosa biocompatible, soluble en agua o hinchable en agua, donde antes de la distribución de la matriz polimérica en y a través del tejido, el tejido contiene aproximadamente 3 por ciento por peso o más de oligosacáridos solubles en agua.
EP 1 574 229 (Gunze Ltd) desvela una película médica que es excelente en biocompatibilidad y 60 bioabsorbencia y tiene una fuerza excelente en sutura y adhesión. Un material de refuerzo hecho de un polímero biodegradable se colca en una solución de gelatina para permitir que la solución se filtre en el material de refuerzo y después la gelatina se seque. Esto permite que la gelatina que se haya filtrado por completo en una parte interna del material de refuerzo se solidifique, formando así una película de gelatina. De este modo, se obtiene una película médica en la que el material de refuerzo y la película de gelatina están integrados. 65
EP 0 815 879 (Johnson & Johnson Medical, Inc.) desvela dispositivos médicos bioabsorbibles preparados oxidando derivados de celulosa, incluyendo metilcelulosa, carboximetilcelulosa y acetato de celulosa. El material resultante se forma en películas, esponjas y geles, y se dice que los dispositivos resultantes son útiles en la limitación de adhesiones quirúrgicas y para hemostasia.
5
Además, los tejidos multicapa son útiles para ingeniería de tejidos y aplicaciones ortopédicas. La reciente emergencia de ingeniería de tejidos ofrece numerosas técnicas para reparar y regenerar tejido dañado/enfermo. Las estrategias de ingeniería de tejidos han explorado el uso de biomateriales que finalmente pueden restablecer o mejorar la función del tejido. Se ha estudiado ampliamente el uso de materiales de andamiaje que pueden colonizarse y remodelarse como plantillas de tejido, conductos, barreras y depósitos. En particular, materiales 10 sintéticos y naturales en forma de espumas, esponjas, geles, hidrogeles, textiles y no hilados se han usado in vitro e in vivo para reconstruir/regenerar tejido biológico, así como administrar agentes quimiotácticos para inducir el crecimiento de tejidos. Las diferentes formas de andamios pueden laminarse para formar un andamio multicapa para ingeniería de tejidos.
15
Sin embargo, la técnica anterior falla en describir o sugerir un tejido multicapa absorbible reforzado que tiene un primer tejido no hilado absorbible reforzado por un segundo tejido hilado o tejido absorbible.
Como aquí se usan, los términos “tejido no hilado” incluyen, aunque no se limitan a, tejidos adheridos, tejidos formados o tejidos diseñados, que se fabrican mediante procesos diferentes a tejer, hilar o tricotar. Más 20 específicamente, los términos “tejido no hilado” se refieren a un material poroso de tipo textil, normalmente en forma de lámina plana, compuesto principalmente o enteramente por fibras de grapa montadas en una red, lámina o guata. La estructura del tejido no hilado se basa en la disposición, por ejemplo, de fibras de grapa que típicamente están dispuestas más o menos aleatoriamente. Las propiedades de tensión, presión-deformación y táctiles del tejido no hilado generalmente detienen a la fibra de la fricción de fibra creada por el entrelazamiento y refuerzo de, por 25 ejemplo, fibras de grapa, y de la unión adhesiva, química o física. Sin embargo, las materias primas usadas para fabricar el tejido no hilado pueden ser hilos, telas tejidas, mallas o filamentos hechos mediante procesos que incluyen tejer, hilar o tricotar.
Resumen de la invención 30
En un primer aspecto, la presente invención proporciona un tejido multicapa que comprende un primer tejido no hilado absorbible y un segundo tejido hilado o tricotado absorbible, caracterizado porque: el primer tejido no hilado absorbible comprende un copolímero de glicólido y láctido; el segundo tejido hilado o tricotado absorbible comprende celulosa oxidada regenerada; y el peso de dicho primer tejido no hilado absorbible es de 10% a 80% del 35 peso total del tejido multicapa.
En un segundo aspecto, la presente invención proporciona un método para hacer el tejido multicapa de acuerdo con la presente invención, que comprende las etapas de: (a) rizar fibras o hilos de un copolímero de glicólido y láctido en el rango de 3,9 a 11,8 rizos por cm (10 a 30 rizos por pulgada); (b) cortar las fibras o hilos 40 rizados a una longitud de grapa de entre 1,9 y 6,4 cm (0,75 a 2,5 pulgadas); (c) cardar la grapa para formar el primer tejido no hilado absorbible; (d) unir el primer tejido no hilado absorbible con el segundo tejido hilado o tricotado absorbible ; mientras (e) controlar la humedad del medio para la etapa (c) de 40 a 60%, a una temperatura ambiente de 15,6 a 23,9 ºC.
45
Descripción detallada de la invención
El primer tejido no hilado absorbible está formado por fibras que comprenden un copolímero de glicólido y láctido. Los poliésteres alifáticos típicamente se sintetizan en una polimerización de abertura de anillo de monómeros que incluyen, aunque no se limitan a, ácido láctico, láctido (incluyendo, mezclas L-, D-, meso y D, L), ácido glicólico y 50 glicólido.
Preferentemente, el primer tejido no hilado absorbible comprende dicho copolímero de glicólido y láctido en una cantidad que oscila entre 70 y 95% por base molar de glicólido y el resto láctido.
55
En una realización alternativa, el primer tejido no hilado absorbible comprende fibras formadas por el copolímero de glicólido y láctido, en combinación con fibras oxidadas de polisacárido. El tejido no hilado puede prepararse a partir de hilo, telas tejidas, mallas o filamentos que se hayan hecho mediante procesos que incluyen tejer, hilar o tricotar. El hilo, las telas tejidas, malla y/o filamentos se rizan para aumentar el entrelazamiento entre ellos y se unen al segundo tejido hilado o tricotado absorbible. Tales hilos, telas tejidas, mallas y/o filamentos rizados 60 pueden después en grapas que sean lo suficientemente largas para enredarse. La grapa puede medir entre 3,8 y 5,1 cm (1,4 y 2,0 pulgadas). La grapa puede cardarse para crear una guata no hilada, que después puede someterse a punzonado o calandrado en el primer tejido no hilado absorbible. Además, la grapa puede estar enroscada o apilada.
Pueden utilizarse otros métodos conocidos para la producción de tejidos no hilados e incluyen procesos 65 tales como colocación de aire, formación de humedad y adhesión con puntos. Tales procedimientos se analizan de
manera general en la Enciclopedia de Ciencia e Ingeniería de Polímeros, Vol. 10, páginas 204-253 (1987) ye Introducción a No Hilados por Albin Turbank (Tappi Press, Atlanta, GA 1999).
El grosor del tejido no hilado puede oscilar entre 0,25 y 2 mm. El peso base del tejido no hilado oscila entre 16 y 310 g/m2 (0,01 y 0,2 g/plg2) preferentemente entre 47 y 160 g/m2 (0,03 y 0,1 g/plg2) y más preferentemente 5 entre 62 y 120 g/m2 (0,04 y 0,8 g/plg2). El porcentaje de peso del primer tejido no hilado absorbible oscila entre 10 y 80 por ciento, en base al peso total del tejido multicapa absorbible reforzado.
El segundo tejido hilado o tricotado absorbible funciona como el tejido de refuerzo y comprende celulosa oxidada regenerada. La celulosa regenerada es preferente debido a grado más alto de uniformidad frente a celulosa 10 que no has sido regenerada. La celulosa regenerada y una descripción detallada de cómo hacer celulosa oxidada regenerada se expone en USP 3.364.200, USP 5.180.398 y USP 4.626.253.
Ejemplos de tejidos que pueden utilizarse como el tejido de refuerzo incluyen, aunque no se limitan a, barrera de adhesión absorbible Interceed®, hemostato absorbible Surgicel®; hemostato absorbible Surgicel Nu-15 Knit® y hemostato absorbible fibrilar Surgicel® (cada uno disponible en Johnson & Johnson Wound Management Worlwide o Gynecare Worlwide, divisiones de Ethicon, Inc., Somerville, Nueva Jersey).
El tejido de refuerzo utilizado en la presente invención puede hilarse o tricotarse, siempre y cuando el tejido posea las propiedades físicas necesarias para su uso en aplicaciones contempladas. Tales tejidos, por ejemplo, se 20 describen en USP 4.626.253, USP 5.002.551 y USP 5.007.916. En realizaciones preferentes, el tejido de refuerzo es un tejido de punto por urdimbre construido de hilo brillante de rayón que posteriormente se oxida para incluir porciones de carboxilo o aldehído en cantidades efectivas para proporcionar biodegradabilidad a los tejidos.
En una realización alternativa, el segundo tejido hilado o tricotado absorbible comprende fibras de celulosa 25 oxidada regenerada en combinación con fibras compuestas por polímeros de poliéster alifático, copolímeros o combinaciones de los mismos.
El segundo tejido hilado o tricotado absorbible comprende celulosa oxidada regenerada y puede tener un peso base que oscila entre 0,00016 y 0,031 g/cm2 (0,001 a 0,2 g/plg2), preferentemente en el rango de 0,0016 a 30 0,016 g/cm2 (0,01 a 0,1 g/plg2), y más preferentemente en el rango de 0,0062 a 0,011 g/cm2 (0,04 a 0,07 g/plg2).
El primer tejido no hilado absorbible está unido al segundo tejido hilado o tricotado absorbible, directamente o indirectamente. Por ejemplo, el tejido no hilado puede incorporarse al segundo tejido hilado o tricotado absorbible por medio de punzonado, calandrado, grabado en relieve o hidroentrelazamiento, o adhesión química o térmica. La 35 grapa del primer tejido no hilado absorbible puede estar entrelazada e introducirse en el segundo tejido hilado o tricotado absorbible. Más particularmente, para métodos diferentes a la adhesión química o térmica, el primer tejido no hilado absorbible puede estar unido al segundo tejido hilado o tricotado absorbible de tal manera que al menos el 1% de la grapa del primer tejido no hilado absorbible está expuesto en el otro lado del segundo tejido hilado o tricotado absorbible, preferentemente 10-20% y preferentemente no más del 50%. Esto asegura que el primer tejido 40 no hilado absorbible y el segundo tejido hilado o tricotado absorbible permanezcan unidos y no se laminen bajo condiciones normales de manipulación. El tejido multicapa absorbible reforzado es uniforme de tal manera que sustancialmente ninguna parte del segundo tejido hilado o tricotado absorbible está visiblemente libre de cobertura por el primer tejido no hilado absorbible.
45
Un método para hacer el tejido multicapa aquí descrito es mediante el siguiente proceso. Fibras de polímero absorbible, con un dtex por fibra de 1,12 a 4,4 dtex (de 1 a 4 denier) pueden consolidarse en hilo multifilamento de 88 a 132 dtex (de 80 a 120 denier) y después a hilos de 880 a 1320 dtex (de 800 a 1200 denier), rizados térmicamente y después cortados en una grapa que tiene una longitud de entre 1,9 y 2,81 cm (0,74 a 1,5 pulgada). La grapa puede introducirse en una máquina de cardado en seco con múltiples rodillos una o más veces y 50 cardarse en una guata no hilada uniforme, mientras se controla la humedad entre 40-60% a una temperatura ambiente de 15,6 a 23,9 ºC (60 a 75 ºF). Por ejemplo, la guata no hilada uniforme puede estar hecha usando un cardado superior por un rollo cilíndrico que tiene un cilindro principal cubierto por un rodillo que quita lo cardado y lo deposita en un rodillo colector. La guata puede procesarse después por medio de punzonado o cualquier otro medio tal como calandrado. Después, el primer tejido no hilado absorbible puede unirse al segundo tejido hilado o tricotado 55 absorbible mediante varias técnicas tales como punzonado. El tejido multicapa absorbible reforzado puede después limpiarse mediante lavado en un disolvente apropiado bajo condiciones suaves durante 30 minutos.
Es deseable controlar los parámetros del proceso tales como longitud de grapa, abertura de grapa, velocidad de introducción de grapa y humedad relativa. De acuerdo con la invención, los hilos consolidados tienen 60 de 3,9 a 11,8 rizos por cm (10 a 30 rizos por pulgada). Es deseable el corte eficiente de los hilos rizados, ya que cualquier grapa larga y cortada incompletamente tiende a pegarse en la máquina de cardado y provoca pelusa. De acuerdo con la invención, la longitud de grapa es de 1,9 a 6,4 cm (0,75 a 2,5 pulgadas) y preferentemente de 3,81 a 5,08 cm (1,5 a 2,0 pulgadas).
65
Para optimizar la uniformidad y minimizar la acumulación de electricidad estática, la humedad relativa se controla durante el procesamiento de guata, preferentemente durante el cardado para formar la guata no hilada uniforme. La guata no hilada se procesa usando un proceso de cardado en seco en una humedad relativa de 40 a 60% a una temperatura ambiente de 15,6 a 23,9 ºC (60 a 75 ºF). Más preferentemente, la guata no hilada se procesa en una humedad relativa de desde 50% a 60%. 5
El tejido multicapa se limpia usando disolventes adecuados para disolver cualquier acabado de hilo. Los disolventes incluyen, aunque no se limitan a, alcohol isopropílico, acetato de etilo y cloruro de metileno. El tejido multicapa después se seca bajo condiciones para proporcionar un suficiente secado mientras se minimiza su encogimiento. 10
El tejido multicapa absorbible reforzado puede tener un grosor medio de entre 0,75 y 3,00 mm, preferentemente entre 1,00 y 2,5 mm, y más preferentemente entre 1,2 y 2,0 mm. El peso base del tejido multicapa absorbible reforzado es entre 0,0078 y 0,039 g/cm2 (0,05 y 0,25 g/plg2), preferentemente entre 0,012 y 0,031 g/cm2 (0,08 y 0,2 g/plg2), y más preferentemente entre 0,016 y 0,028 g/cm2 (0,1 y 0,18 g/plg2). El tejido multicapa 15 absorbible reforzado es uniforme de manera que no hay más del 10% de variación (desviación estándar relativa de la media) en el peso base o grosor en cada centímetro cuadrado (pulgada).
Además, el tejido multicapa absorbible reforzado puede contener agentes biológicamente activos, tales como agentes hemostáticos. Los agentes hemostáticos que pueden usarse incluyen, sin limitación, enzimas, 20 proteínas y péptidos pro-coagulantes, que ocurren de manera natural, recombinantes o sintéticos. Más específicamente, puede utilizarse protrombina, trombina, fibrinógeno, fibrina, fibronectina, Factor X/Xa, Factor VII/VIIa, Factor XI/XIa, Factor XII/XIIa, factor de tejido, Factor de von Willebrand, elastina, gelatina, péptidos sintéticos con actividad hemostática, derivados de los anteriores y cualquier combinación de los mismos.
25
Además, el tejido no hilado puede comprender agentes farmacológicamente y biológicamente activos, incluyendo aunque sin limitar, agentes curativos de heridas, agentes antibacterianos, agentes antimicrobianos, factores del crecimiento, agentes analgésicos y anestésicos. Cuando se usa como andamio para tejido, el tejido multicapa absorbible reforzado puede sembrarse o cultivarse con tipos apropiados de célula antes de la implantación en el tejido al que va dirigido. 30
Ejemplo 1 Tejido PGL no hilado con tejido COR
Poli(glicólido-co-láctido) (PGL, 90/10 mol/mol) se torneó en estado de fusión en la fibra. Un hilo multi-filamento se consolidó, rizó y cortó en una grapa que tenía una longitud de 4,45 cm (1,75 pulgadas). La grapa se 35 cardó para crear una guata no hilada y después se compactó a un grosor de 1,25 mm y una densidad de 98,1 mg/cc. El tejido no hilado después se sometió a punzonado en una celulosa oxidada regenerada (COR) carboxílica tejida, disponible en Ethicon, Inc., bajo el nombre comercial Interceed®, para asegurar el tejido no hilado al tejido COR. El tejido multicapa final comprendió 60 por ciento de peso del tejido no hilado.
40
Ejemplo 2 Tejido PGL no hilado con tejido COR
Poli(glicólido-co-láctido) (PGL, 90/10 mol/mol) se torneó en estado de fusión en la fibra. Un hilo multi-filamento se consolidó, rizó y cortó en una grapa que tenía una longitud de 4,45 cm (1,75 pulgadas). La grapa se cardó para crear una guata no hilada y después se compactó a un grosor de 1,22 mm y una densidad de 103,4 45 mg/cc. El tejido no hilado después se sometió a punzonado en una celulosa oxidada regenerada (COR) carboxílica tejida, disponible en Ethicon, Inc., bajo el nombre comercial Surgicel NuKnit®, para asegurar el tejido no hilado al tejido COR. El tejido multicapa final comprendió 25 por ciento de peso del tejido no hilado.
Ejemplo 3 Tejido PGL no hilado con tejido COR 50
Poli(glicólido-co-láctido) (PGL, 90/10 mol/mol) se torneó en estado de fusión en la fibra. Un hilo multi-filamento se consolidó, rizó y cortó en una grapa que tenía una longitud de 4,45 cm (1,75 pulgadas). La grapa se cardó para crear una guata no hilada y después se compactó a un grosor de 1,1 mm y una densidad de 102,8 mg/cc. El tejido no hilado después se sometió a punzonado en una celulosa oxidada regenerada (COR) carboxílica tejida, 55 disponible en Ethicon, Inc., bajo el nombre comercial Surgicel®, para asegurar el tejido no hilado al tejido COR. El tejido multicapa final comprendió 60 por ciento de peso del tejido no hilado.
Ejemplo 4 Tejido PGL no tejido con tejido COR
60
Poli(glicólido-co-láctido) (PGL, 90/10 mol/mol) se torneó en estado de fusión en la fibra. Un hilo multi-filamento de 88 dtex (80 denier) se consolidó en un hilo consolidado de 880 dtex (800 denier). El hilo consolidado se rizó a 110 grados C. El hilo rizado se cortó en una grapa que tenía una longitud de 3,18 cm (1,25’’). 20 g de la grapa rizada se pesó de manera precisa y se colocó uniformemente en la cinta transportadora de alimentación de una máquina de cardado con múltiples rodillos. Se controlaron las condiciones ambientales (temp: 21,1 ºC (70 grados 65
F)/55% HR). La grapa después se cardó para crear una guata no hilada. La guata se retiró del rodillo de recogida y se cortó en 4 partes iguales. Estas se volvieron a introducir en la máquina de cardado perpendicularmente a la dirección de recogida. Después de este segundo paso la guata se pesó (19,8 g: 99% producción de tejido) y después se compactó en un fieltro. El fieltro compacto se colocó de manera precisa en un tejido COR y se unió por medio de 2 pasos en el equipo de punzonado. El tejido multicapa se recortó y limpió en 3 baños distintos de alcohol 5 isopropílico para retirar el acabado de hilo y cualquier aceite de la máquina. El tejido multicapa limpiado se secó en un horno a 70 grados C durante 30 minutos, se enfrió y se pesó.
El “grosor” del tejido multicapa se midió como aquí se describe. Las herramientas de medición fueron:
(1) Calibrador Mitutoyo Absolute Modelo número ID-C125EB [Código número –543—452B]. En el calibrador se usó 10 el pie de diámetro de 2,54 cm (1’’).
(2) Se usó un recipiente magnético para inmovilizar en su sitio el calibrador en la plantilla matriz.
(3) Dos placas de metal de 6,99 x 5,08 x 1,52 cm (2,75’’ x 2’’ x 0,60’’) que pesaban entre 40,8 g y 41,5 g [combinadas total de ~82,18 g].
15
El tejido multicapa se colocó en una superficie de platina que es una superficie lisa y fabricada. Las dos placas de metal se colocaron una sobre otra en el tejido multicapa y se apretaron suavemente en sus esquinas para asegurar que el tejido multicapa estuviera plano. El pie del calibrador se colocó sobre la parte superior de las placas de metal y después se volvió a levantar y se volvió a colocar, momento en el cual se hizo una lectura.
20
12 piezas de 2,54 x 2,54 cm (1’’ x 1’’) se tallaron del tejido multicapa limpiado y se pesaron de manera precisa. El grosor de cada pieza de 2,54 x 2,54 cm (1’’ x 1’’) se midió 4-5 veces en diferentes áreas de la placa de metal con el fin de obtener un promedio fiable. El peso y grosor de cada pieza se muestra en la tabla 1. Los valores indican la cobertura de ambas capas es similar en todas las direcciones.
25
TABLA 1
- Muestra #
- Lámina #1 Peso (g) Grosor (mm) Lámina #2 Peso (g) Grosor (mm)
- 1
- .132 1,53 .13 1,58
- 2
- .132 1,58 .124 1,57
- 3
- .131 1,59 .13 1,62
- 4
- .129 1,55 .134 1,64
- 5
- .126 1,58 .126 1,56
- 6
- .125 1,5 .131 1,59
- 7
- .129 1,56 .136 1,7
- 8
- .127 1,52 .131 1,62
- 9
- .132 1,55 .131 1,57
- 10
- .123 1,58 .136 1,58
- 11
- .128 1,58 .135 1,65
- 12
- .13 1,51 .133 1,55
- Promedio
- .1287 1,5525 0.1314 1,6025
- Desv. Est.
- 0.0029 0,031 0.0037 0,044
- CB (%)
- 2,304 2,002 2,837 2,767
30
35
40
45
50
55
Ejemplo 5. Efecto de humedad en el procesamiento de grapa de poliglactina 910
Hilo consolidado de poliglactina 910 de 88 dtex (80 denier) se rizó y cortó en una grapa de 4,45 cm (1,75 pulgadas). La temperatura ambiente se mantuvo entre 20,6-21,1 ºC (69-70 ºF) y la humedad relativa se controló con 60 un humidificador en la habitación y varió de 36-60%. La grapa rizada se cardó en una guata de 81,3 x 20,3 cm (32’’ x 8’’). El porcentaje de grapa incorporada en la guata después de dos pasos a través de la máquina de cardado, esto es, la producción aumentó con mayor humedad, y la calidad de la guata mejoró con la producción.
Tabla 2: Efecto de humedad relativa en el procesamiento
- Peso de grapa (g)
- %HR Peso de guata (g) Producción % Calidad de guata
- 27
- 36 17 63 3,5
- 27
- 38-45 18,4 68 4,0
- 20,9
- 40 13,8 66 3,0
- 20,1
- 49 14,9 74 4,5
- 33
- 49 24,4 74 5,0
- 25,5
- 60 21,9 86 5,0
5
10
15
*La calidad se midió en una escala de 1-5 en base a inspección visual.
1=áreas grandes desprovistas de poliglactina 910, manchas, pelusa
3=algunas manchas escasas y pequeñas de poliglactina 910 o manchas muy finas con cobertura mínima de poliglactina 910
5=uniforme mediante inspección visual – sin manchas, sin manchas muy finas, sin pelusa 20
Ejemplo 6. Efecto de longitud de grapa en el procesamiento de grapa de poliglactina 910
Hilo consolidado de poliglactina 910 de 88 dtex (80 denier) se rizó y cortó en una grapa de una longitud de 3,18 cm (1,25’’), 3,81 cm (1,5’’) y 4,45 cm (1,75’’). La temperatura ambiente se mantuvo entre 20,6-21,1 ºC (69-70 25 ºF) y la humedad relativa se controló en ~55% con un humidificador en la habitación. La grapa rizada se cardó en una guata de 81,3 x 20,3 cm (32’’ x 8’’).
Tabla 3: Efecto de longitud de grapa en calidad y producción de guata en 55% HR.
30
- Longitud de grapa (plg) cm
- Peso de grapa (g) Peso de guata (g) Producción % Calidad de guata
- (1,75) 4,45
- 25 13,94 56 4,0
- (1,75) 4,45
- 25 16,0 64 5,0
- (1,5) 3,81
- 30,7 28,0 91 ND
- (1,5) 3,81
- 25 21,8 87 ND
- (1,25) 3,18
- 25 24,1 96 5,0
- (1,25) 3,18
- 25 24,2 97 5,0
35
40
*La calidad se midió en una escala de 1-5 en base a inspección visual.
1=áreas grandes desprovistas de poliglactina 910, manchas, pelusa 45
3=algunas manchas escasas y pequeñas de poliglactina 910 o manchas muy finas con cobertura mínima de poliglactina 910
5=uniforme mediante inspección visual – sin manchas, sin manchas muy finas, sin pelusa
Ejemplo 7. Reparación de manguito rotador usando tejido multicapa absorbible reforzado 50
En el caso de problema con un manguito rotador, el cirujano primer mira la extensión de la lesión usando un artroscopio. Después, bajo anestesia general, el paciente se someta a cirugía abierta para reparar la rotura.
Después de administrar la anestesia y de preparar el hombro, se realiza una incisión cosmética sobre la 55 esquina delantera superior del hombro. Esta incisión permite el acceso a la unión entre las partes delanteras y medias del músculo deltoides. La escisión de esta unión permite el acceso al manguito rotador sin separar o dañar el músculo deltoides importante, que es responsable de una parte significativa de la fuerza del hombro. Se retira todo el tejido cicatricial del espacio bajo el deltoides y el acromion (parte de la escápula a la que está unido el hombro). También se alisan la bolsa engrosada y los bordes rugosos del manguito rotador y el húmero (hueso del brazo 60 superior) para asegurar que pasen suavemente bajo el acromion y deltoides.
Se identifican los bordes de los tendones del manguito y se determina la calidad y cantidad del tejido del manguito. El objetivo de la reparación es volver a unir un tendón de buena calidad a la localización sobre el hueso del brazo del que se ha desgarrado. Se moldea una ranura o depresión en el sitio normal de unión para el manguito. 65 Para sujetar el tendón y ayudar a su curación el cirujano sutura un parche de tejido multicapa absorbible reforzado
en su lugar sobre él. Las suturas (longitudes de hilo quirúrgico) dibujan el borde del tendón de manera segura en la ranura en la que se curará.
Después el cirujano completa la cirugía cerrando el músculo deltoides y la incisión en la piel. Con el paso del tiempo, el cuerpo crea tejido nuevo en el área que corresponde al tejido circundante. El cuerpo también absorbe 5 el parche implantado en un periodo de dos a cuatro meses.
Ejemplo 8. Reparación de cartílago de rodilla usando tejido multicapa absorbible reforzado
Primero, el cirujano examina la rodilla a través de un artroscopio, un pequeño dispositivo que permite al 10 doctor ver el interior de la articulación de la rodilla. Si se detecta una lesión se realiza un procedimiento quirúrgico.
Después de administrar la anestesia y de preparar la rodilla, se realiza una incisión cosmética a través de la piel sobre la esquina delantera superior de la rótula. Primero, se retira el cartílago dañado. Después, el tejido multicapa absorbible reforzado se implanta en la lesión. El tejido puede unirse al sitio de la lesión con suturas, 15 chinchetas o cualquier número de pegamentos biocompatibles.
Después el cirujano completa la cirugía cerrando la incisión en la piel. Las células del cartílago migran y se multiplican en el tejido implantado, y el implante de células/tejido se integra con el cartílago circundante. Con el paso del tiempo, las células madurarán y rellenarán la lesión con cartílago hialino. 20
Todos los tejidos de refuerzo descritos en los ejemplos abajo son los materiales no estériles de los correspondientes productos comerciales referidos con sus nombres comerciales.
Claims (11)
- REIVINDICACIONES1. Un tejido multicapa que comprende un primer tejido no hilado absorbible y un segundo tejido hilado o tricotado absorbible, caracterizado porque:el primer tejido no hilado absorbible comprende un copolímero de glicólido y láctido; 5el segundo tejido hilado o tricotado absorbible comprende celulosa oxidada regenerada; yel peso de dicho primer tejido no hilado absorbible es de 10% a 80% del peso total del tejido multicapa.
- 2. El tejido multicapa de la reivindicación 1, donde el segundo tejido absorbible es un tejido tricotado.10
- 3. El tejido multicapa de la reivindicación 1, donde dicho tejido multicapa consiste en dicho primer tejido no hilado absorbible y dicho segundo tejido hilado o tricotado absorbible.
- 4. El tejido multicapa de la reivindicación 1, donde dicho primer tejido no hilado absorbible se ha unido a dicho segundo tejido hilado o tricotado absorbible mediante punzonado. 15
- 5. Un método para hacer el tejido multicapa de cualquier reivindicación precedente, que comprende las etapas de:(a) rizar fibras o hilos de un copolímero de glicólido y láctido en el rango de 3,9 a 11,8 rizos por cm (10 a 30 rizos por pulgada);(b) cortar las fibras o hilos rizados a una longitud de grapa de entre 1,9 y 6,4 cm (0,75 a 2,5 pulgadas); 20(c) cardar la grapa para formar el primer tejido no hilado absorbible;(d) unir el primer tejido no hilado absorbible con el segundo tejido hilado o tricotado absorbible; mientras (e) controlar la humedad del medio para la etapa (c) de 40 a 60%, a una temperatura ambiente de 15,6 a 23,9 ºC.
- 6. El método de la reivindicación 5, donde dicho copolímero de glicólido y láctido comprende de 70 a 95% por base 25 molar de glicólido y el resto láctido.
- 7. El método de la reivindicación 5 ó 6, donde las fibras de un copolímero de glicólido y láctido oscilan entre 1,1 y 4,4 dtex (1 a 4 denier) por filamento.30
- 8. El método de una cualquiera de las reivindicaciones 5 a 7, donde el primer tejido no hilado absorbible tiene un peso base de 16 a 310 g/m2 (0,01 a 0,2 g/plg2); y el segundo tejido no hilado o tricotado tiene un peso base de 1,6 a 310 g/m2 (0,001 a 0,2 g/plg2).
- 9. El método de la reivindicación 5, donde dicha grapa tiene una longitud de 3,8 a 5,1 cm (1,5 a 2,0 pulgadas). 35
- 10. El método de la reivindicación 6, donde dicha grapa tiene una longitud de 3,8 a 5,1 cm (1,5 a 2,0 pulgadas).
- 11. El método de la reivindicación 6, donde el primer tejido no hilado absorbible está unido a dicho segundo tejido hilado o tricotado absorbible mediante punzonado. 40
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US62062404P | 2004-10-20 | 2004-10-20 | |
US620624P | 2004-10-20 | ||
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- 2005-10-17 WO PCT/US2005/037402 patent/WO2006044878A2/en active Application Filing
- 2005-10-17 EP EP11161264.4A patent/EP2345430B1/en active Active
- 2005-10-17 US US11/252,120 patent/US7666803B2/en active Active
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- 2005-10-17 CN CN2005800436170A patent/CN101137402B/zh active Active
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