ES2543082T3 - Apósito para heridas - Google Patents
Apósito para heridas Download PDFInfo
- Publication number
- ES2543082T3 ES2543082T3 ES03789851.7T ES03789851T ES2543082T3 ES 2543082 T3 ES2543082 T3 ES 2543082T3 ES 03789851 T ES03789851 T ES 03789851T ES 2543082 T3 ES2543082 T3 ES 2543082T3
- Authority
- ES
- Spain
- Prior art keywords
- absorbent core
- silicone
- support layer
- layer
- dressing
- 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.)
- Expired - Lifetime
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- 239000002250 absorbent Substances 0.000 abstract description 41
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Landscapes
- Health & Medical Sciences (AREA)
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- Epidemiology (AREA)
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- Hematology (AREA)
- Dispersion Chemistry (AREA)
- Manufacturing & Machinery (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Materials For Medical Uses (AREA)
- Absorbent Articles And Supports Therefor (AREA)
- Laminated Bodies (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Un apósito para heridas, que comprende: un núcleo absorbente que tiene superficies opuestas proximal y distal, y que define porciones de borde y central a lo largo de la superficie distal del mismo; y una capa de soporte permeable al vapor e impermeable a los líquidos conectada al núcleo absorbente, teniendo dicha capa de soporte al menos un reborde compatible disociado del núcleo absorbente, en el que el al menos un reborde compatible corresponde a una porción intermedia del núcleo absorbente interpuesta entre las porciones de borde y central del mismo, en el que el núcleo absorbente tiene un espesor en la porción central del mismo que es menor que el espesor en la porción intermedia.
Description
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E03789851
20-07-2015
Las partículas súper absorbentes están preferentemente en la forma de gránulos o escamas para proporcionar un hidrocoloide de mayor área superficial disponible. El tamaño de las partículas súper absorbentes está típicamente dentro del intervalo de 1 a 1000 micrómetros cuando se seca. Preferentemente, el intervalo de tamaño de partícula de las partículas absorbentes es de 100 a 900 micrómetros. Las partículas que son insolubles en un entorno de la herida tienen una capacidad de absorción mayor que 0,5 de agua por gramo de partículas secas.
En otra realización, el material absorbente puede ser un gel hidrófilo que se hincha al contacto con agua. El gel hidrófilo carece generalmente de una estructura interna celular o vacía, y está en forma de un sólido o semi-sólido. El gel hidrófilo se puede interpretar en el sentido de hidrocoloides, hidrogeles y combinaciones de los mismos, siempre y cuando el material sea fisiológicamente tolerable y clínicamente aceptable. Una descripción de geles hidrófilos adecuados se proporciona en el documento US 6.566.575 concedido a Stickels et al. y dichos geles hidrófilos están disponibles en el mercado.
En otra realización del apósito para heridas, el núcleo absorbente puede incluir una pluralidad de porciones discretas de material absorbente enredadas en el núcleo absorbente. Tales porciones discretas de material absorbente pueden ser granulados, escamas o polvos poliméricos superabsorbentes discretos que se disponen libremente en el núcleo absorbente para que puedan migrar dentro del núcleo absorbente, y preferentemente hacia la superficie distal del mismo. En otra realización adicional del apósito para heridas, el núcleo absorbente puede incluir tanto material absorbente enredado en el mismo como los receptáculos que contienen porciones discretas de material absorbente.
En resumen, en cada una de las realizaciones de núcleo absorbente descritas hasta ahora, es notable que la absorción del fluido en la porción del núcleo absorbente cerca o en su porción proximal se minimiza, y la absorción de fluido maximiza la absorción del material absorbente en o más allá de los receptáculos. Tal mecanismo maximiza la cantidad de líquido que el apósito puede absorber, en combinación con la configuración de la capa de soporte, y permite además un mayor tiempo de desgaste para el paciente ya que el fluido no está en contacto con la piel.
Una capa de soporte puede estar presente en todas las realizaciones del apósito de la presente invención. Preferentemente, la capa de soporte se puede adaptar a superficies anatómicas animales (incluidos los humanos), es impermeable a líquido y es permeable al vapor. Como se ha descrito anteriormente, la capa de soporte, en combinación con el núcleo absorbente, se puede construir para definir un reservorio entremedio cuando el apósito está en un estado cargado con humedad y expandido. Si bien la capa de soporte no permite el paso de un líquido o exudado, la humedad en el exudado absorbido pasa a través de la capa de soporte en forma de vapor hasta la atmósfera.
La realización preferida para la capa de soporte es un revestimiento de película elástico o flexible polimérico fino que proporciona una barrera bacteriana formada a partir de un material de elastómero flexible permeable al vapor de agua. La película es continua porque no tiene perforaciones o poros que se extienden a través del espesor de la película. Las películas de este tipo son conocidas y, generalmente, son materiales poliméricos hidrófilos a través de los que el vapor de agua se puede difundir.
La capa de soporte se fija a la superficie proximal del núcleo absorbente, y en una realización preferida, la capa de soporte se fija solo a la superficie distal del núcleo absorbente y no penetra ninguno de los poros, células o cavidades en su interior. Generalmente, la película es de 15 a 45 micrómetros de espesor, con un espesor preferido de aproximadamente 30 micrómetros. La capa de soporte puede comprender poliuretano, tal como una película de poliuretano disponible por InteliCoat Technologies (South Hadley, MA) bajo la designación de producto INSPIRE, poliéster elastomérico, mezclas de poliuretano y poliéster, cloruro de polivinilo, y copolímero de bloques de poliéteramida. La capa de soporte preferida para su uso en la presente invención es una película de poliuretano ya que exhibe una propiedad resiliente que permite que la película tenga buena capacidad de conformación y tenga además un alto grado de capacidad de estiramiento.
Se prefiere que la capa de soporte de la presente invención sea al menos translúcida, y más preferentemente, suficientemente transparente para que el sitio de la herida al que se aplica el apósito se pueda observar a través del apósito. Es ventajoso observar para evaluar la herida y la curación de la misma sin necesidad de retirar el apósito para evitar la manipulación innecesaria del apósito y la exposición de la herida al medio ambiente, lo que reduce la probabilidad de contaminación.
Las capas de soporte adaptables continuas adecuadas tendrán una tasa de transmisión de vapor de humedad (MVTR) desde la capa de soporte solamente de 1.500 a 14.600 g/m^2/24 horas, preferentemente de 2500 a 2700 g/m^2/24 horas a 38°C. El espesor de la capa de soporte está preferentemente en el intervalo de 10 a 1000 micrómetros, más preferentemente de 100 a 500 micrómetros. La capa de revestimiento de la presente invención es preferentemente una capa hidrófoba, impermeable a líquido y a la humedad unida a la superficie proximal del núcleo absorbente. En una realización preferida, la capa de revestimiento es un gel de elastómero de silicona reticulado, tal como, por ejemplo, una silicona reticulada (gel de polidimetilsiloxano) fabricada por NuSil Technology (Carpenteria, CA) bajo la designación de producto MED-6340. La capa de revestimiento tiene preferentemente un espesor en el intervalo de 0,05 mm a 0,5 mm, y más preferentemente de 0,1 mm. La capacidad de conformación del apósito a la herida es algo dependiente de espesor de los componentes, de tal manera que cuando se aplica el apósito a una
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El espesor de la capa de revestimiento puede variar a través de la longitud de la misma. Por ejemplo, la capa de revestimiento puede incluir regiones que tienen mayor espesor cerca de la porción de borde del apósito para heridas en oposición a la porción central a fin de proporcionar una mayor resistencia a la capa de revestimiento en tales regiones de la misma con una capa de revestimiento más gruesa.
En otra realización, la capa de revestimiento puede incluir al menos dos capas diferentes con propiedades diferentes. Por ejemplo, se puede proporcionar una capa más blanda para utilizarse directamente adyacente al sitio de la herida que se ajusta estrechamente al área de la herida, mientras que se puede proporcionar una capa más dura que esta interpuesta entre la capa más blanda y el núcleo absorbente para proporcionar durabilidad y resistencia al apósito. La capa de revestimiento de durómetro de múltiples capas o más acertadamente dual adopta los principios descritos en la patente de Estados Unidos 6.136.039 concedida el 24 de octubre de 2000 propiedad del cesionario de la invención descrita en la presente memoria, cuya descripción cual se incorpora en la presente memoria.
En otra realización, la capa de revestimiento de la presente invención puede comprender una capa de silicona del tipo mencionado anteriormente que está reforzada con una capa de soporte perforada incrustada. Una capa de soporte de este tipo puede incluir un material textil no tejido, de punto o tejido, o una película polimérica tal como una fabricada de poliuretano. En esta realización, las aberturas en la capa de silicona se corresponden generalmente con las perforaciones de la capa de soporte.
Se entenderá que capas de revestimiento que no son de silicona se pueden emplear en el apósito de la presente invención sin apartarse del alcance de la misma. Preferentemente, tales capas de revestimiento deben ser blandas, flexibles, adaptables, no irritantes y no sensibles. El apósito puede incluir capas de revestimiento que comprenden una película de base perforada construida de una diversidad de polímeros tales como poliuretano, polietileno, polipropileno, poliamida o material de poliéster con un adhesivo sensible a presión. Además, la capa de revestimiento puede estar en la forma de películas permeables al vapor de humedad, películas perforadas, bandas tejidas, no tejidas o de punto o cañamazos. El adhesivo puede ser una microesfera o adhesivo fibroso con propiedades de trauma bajas y tener buena adherencia a la piel húmeda. Se entenderá que el adhesivo puede estar revestido solo en una porción de la capa de revestimiento, por ejemplo, el adhesivo se puede aplicar solamente alrededor de la porción de borde del apósito con la porción central careciendo de un adhesivo. Preferentemente, la capa de revestimiento se debe perforar para permitir el transporte del fluido a través del mismo hasta el núcleo absorbente.
El apósito de la presente invención puede incluir diversas combinaciones de ingredientes, sin apartarse del alcance de la presente invención, incluyendo, por ejemplo, medicamentos, jabones, agentes de desinfección y esterilización, agentes de gestión de olores, hemostáticos, proteínas, enzimas y ácidos nucleicos. Preferentemente, estos agentes se pueden incorporar directamente o dispersarse en el núcleo absorbente, o dispersarse con el material absorbente. Como alternativa, estos ingredientes se pueden incorporar en el apósito por cualquier medio adecuado, incluyendo una capa adicional en el núcleo absorbente que incorpore tales ingredientes.
Los medicamentos, jabones, agentes de desinfección y esterilización, proteínas, y enzimas adecuados están disponibles en el mercado. Preferentemente, tales medicamentos pueden incluir agentes antifúngicos, agentes antibacterianos, agentes que promueven la angiogénesis y otros agentes apropiados.
Como se ha mencionado anteriormente en la observación de la Figura 10, la capa 12 de revestimiento puede incluir un adhesivo que se proporciona cerca de o en una porción de borde periférica de la capa de revestimiento. Preferentemente, este adhesivo es una silicona sensible a presión, tal como un adhesivo de silicona fabricado por NuSil Tecnology (Carpenteria, CA) bajo la designación de producto MED-1356 o una silicona muy pegajosa fabricada por NuSil Tecnology (Carpenteria, CA) bajo la designación de producto MED-6345. El adhesivo de silicona se puede aplicar a una capa de revestimiento de silicona después de que la capa de revestimiento se cura de tal manera que el adhesivo de silicona se aplica a la capa de revestimiento cuando se encuentra en un estado parcialmente curado y se termina de curar después cuando está en la capa de revestimiento. Como alternativa, el adhesivo puede ser un pegamento de acrilato o pegamento de fusión en caliente aplicado sobre la capa de revestimiento utilizando procedimientos convencionales para aplicar un adhesivo a un sustrato.
En un procedimiento preferido de la invención, el gel de silicona pegajoso se prepara a partir de una silicona de dos componentes, tales como las partes MED-6340 A y B producidas por NuSil Technology (Carpenteria, CA). Las dos partes A y B incluyen cada una la misma base, poli (dimetilsiloxano) sustituido con vinilo. Además, la parte A incluye un catalizador de platino para facilitar una reacción entre las partes A y B cuando se mezclan. La parte B incluye una silicona que contiene hidruro, reticulada. Ambas partes A y B se mezclan fácilmente, y se manipulan por separado, no reaccionan ni se curan.
El gel de silicona pegajoso se produce mezclando a fondo las partes A y B en una proporción de 1:1, permitiendo así que el grupo vinilo en la silicona sustituida con vinilo se active por el catalizador y el hidruro que contiene silicona. Esto da lugar a reticulación de la silicona de manera que comenzará a curarse. Uno de los factores que influye en el tiempo requerido para el curado es la temperatura de la combinación mixta de las partes A y B. Un intervalo de temperatura adecuado es de 50-150°C, preferentemente 100-130°C. Otro factor que influye en el tiempo de curado
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es la cantidad de catalizador que se utiliza en la combinación de las partes A y B, sin embargo, el catalizador puede influir también indeseablemente en la pegajosidad del gel de silicona. Típicamente, en la presente invención, el tiempo de curado de un 0,1 mm de espesor capa de revestimiento de gel de silicona curado a 100°C es de aproximadamente 1 minuto, y la capa de revestimiento de gel de silicona se transfiere normalmente al núcleo absorbente cuando está en un estado parcialmente curado en un intervalo de 3 a 12 segundos después de que las partes A y B se han mezclado.
Se entenderá que se proporcionan las etapas antes mencionadas para la preparación del gel de silicona pegajoso para fines ejemplares y que la invención no pretende estar limitada a dichas etapas. Cualquier etapa adecuada para la preparación de una capa de revestimiento pegajosa parcialmente curada se puede utilizar siempre que se encuentre dentro del alcance de la presente invención.
En el contexto de la presente invención, una silicona "parcialmente curada" denota que la silicona no está completamente curada y, por lo tanto, la silicona no está totalmente reticulada. Típicamente, los parámetros para la obtención de una capa de silicona parcialmente curada se deben establecer empíricamente con respecto a la mezcla de gel y el material absorbente utilizado. Si bien los parámetros para la obtención de una capa de silicona "parcialmente curada" pueden variar, la proporción de tiempo requerido para el gel de silicona para convertirse en completamente curada se puede emplear para determinar si la capa de silicona se cura parcialmente. Específicamente, en la presente invención, la capa de silicona se cura parcialmente entre el 5-70% del tiempo total requerido para curar el gel de silicona. De ello se deduce que el intervalo de tiempo para aplicar la capa de revestimiento al núcleo absorbente está entre el 5-40%, o más preferentemente el 5-20%.
Cuando se cura la capa de silicona, se puede utilizar un catalizador para acelerar el tiempo de curado y reducir la pegajosidad del gel de silicona. Un catalizador de silicona está disponible comercialmente por NuSil Technology (Carpenteria, CA) bajo la designación de producto CAT-50.
Un procedimiento para asegurar la capa 16 de soporte al núcleo 14 absorbente y formar el elemento 26 compatible se realiza preferentemente como se ilustra en las Figuras 14-19. En un procedimiento preferido, una placa 66 de presión, como se muestra en la Figura 14, se puede proporcionar y configurar con una superficie 70 perfilada que corresponde al elemento 26 compatible y a las porciones 22 central, 23 intermedia y de borde 24 de un apósito de una realización de un apósito para heridas de la invención. La placa 66 de presión está selectivamente en comunicación con un vacío configurado para extraer un vacío a lo largo de su superficie 70 perfilada y se calienta a una temperatura en el intervalo de 150-200°C, preferentemente 185°C. En una realización preferida, la placa 66 de presión incluye una ranura 68 que se extiende alrededor de la superficie 70 perfilada que define la forma del elemento 26 compatible. La placa 66 incluye al menos un paso 72 en comunicación con la ranura 68 y un vacío. La placa 66 puede incluir también un borde 74 de cuchilla que se extiende alrededor del borde periférico de la superficie 72 perfilada y una porción 76 biselada cerca del borde periférico.
La placa 66 de presión incluye al menos una porción rebajada, tal como las porciones 78, 80, 82 y 84 rebajadas mostradas en la Figura 14, que se puede disponer alrededor de una porción central de la placa 66 de presión. Las porciones 78, 80, 82 y 84 rebajadas se definen preferentemente en una configuración escalonada con la porción 84 central rebajada que es relativamente más profunda que una primera porción 78 rebajada. La al menos una porción rebajada se proporciona para reducir la presión ejercida en la región localizada del núcleo absorbente correspondiente. Esto da como resultado, al menos en parte, la disminución del nivel de adherencia de la capa de soporte en dicha región localizada en el núcleo absorbente. Se observará que la placa de presión no está limitada teniendo porciones rebajadas solo en una porción central de la misma y que se puede proporcionar a lo largo de cualquier porción de la placa donde se desea tener una región localizada de menor adherencia de una capa de soporte a un núcleo absorbente.
La placa 66 de presión puede incluir una pluralidad de tales pasos 72 que se utilizan para comunicar el vacío con una capa 16 de soporte. Por ejemplo, la placa 66 de presión puede incluir 8 pasos igualmente separados alrededor de la ranura 68 cuando un núcleo absorbente tiene una forma generalmente rectangular. En este ejemplo, un paso se puede proporcionar en una ubicación correspondiente con la porción intermedia del núcleo absorbente y un paso se puede proporcionar entre cada esquina. Por otra parte, la placa de presión puede incluir al menos un paso 73 adicional que está en comunicación con el aire comprimido, y se tal manera que al menos un paso adicional se puede disponer sobre la placa de presión en correspondencia con cualquiera de las porciones central o de borde.
Se observará que la placa de presión se pueden configurar de acuerdo con la forma del apósito para heridas eventual y sus características individuales. Por ejemplo, la placa de presión se puede disponer en una forma generalmente circular con una ranura que es generalmente circular.
Como se muestra en la Figura 15, la capa 16 de soporte se coloca sobre el núcleo 14 absorbente y, a continuación, como se muestra en la Figura 16, la placa 66 de presión se sitúa contra la capa 16 de soporte y extrae la capa 16 de soporte hacia su superficie 70 perfilada por el vacío. La placa 66 de presión se extrae continuamente hacia el núcleo 14 absorbente mientras que extrae la capa 16 de soporte en contra de su superficie 70 perfilada. Cabe destacar que una porción de la capa 16 de soporte se extrae preferentemente en la ranura 68, formando de ese modo al menos una porción del elemento 26 compatible. En la Figura 16, la placa 66 de presión se calienta en las porciones de la
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