ES2546393T3 - Implante quirúrgico tipo malla - Google Patents
Implante quirúrgico tipo malla Download PDFInfo
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- ES2546393T3 ES2546393T3 ES05732926.0T ES05732926T ES2546393T3 ES 2546393 T3 ES2546393 T3 ES 2546393T3 ES 05732926 T ES05732926 T ES 05732926T ES 2546393 T3 ES2546393 T3 ES 2546393T3
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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
- 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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/507—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
-
- 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
- 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
- A61L31/04—Macromolecular materials
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
- C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L23/10—Homopolymers or copolymers of propene
- C08L23/12—Polypropene
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L5/00—Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
- C08L5/04—Alginic acid; Derivatives thereof
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L67/00—Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
- C08L67/02—Polyesters derived from dicarboxylic acids and dihydroxy compounds
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L67/00—Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
- C08L67/04—Polyesters derived from hydroxycarboxylic acids, e.g. lactones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
- A61F2250/0031—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
- C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L23/10—Homopolymers or copolymers of propene
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Vascular Medicine (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Dermatology (AREA)
- Polymers & Plastics (AREA)
- Chemical Kinetics & Catalysis (AREA)
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- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Abstract
Una prótesis quirúrgica para la reparación de un defecto de una pared abdominal o una pared de la cavidad pélvica, que comprende: una malla tridimensional que comprende al menos dos tipos de hilo enrollados entre sí o entrelazados para definir al menos dos capas, en la que una de las al menos dos capas es sustancialmente no biodegradable y porosa para permitir el crecimiento del tejido hacia el interior y otra de las al menos dos capas es sustancialmente biodegradable; y una barrera de adhesión en forma de una película, espuma o gel, en la que la barrera de adhesión está interconectada con la capa sustancialmente biodegradable, en la que la capa sustancialmente no biodegradable define una primera superficie exterior de la prótesis y la barrera de adhesión define una segunda superficie exterior de la prótesis; y en la que la capa sustancialmente biodegradable está posicionada entre la capa sustancialmente no biodegradable y la barrera de adhesión.
Description
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segunda defensa contra la prevención de adhesiones. Como se describe anteriormente, la capa 37 es absorbida por el cuerpo durante un período de aproximadamente 60 a 90 días. Como resultado de esto, cualquier adhesión que se pudiera formar debido a un fallo de la barrera de adhesión 20, o después de que la barrera de adhesión 20 sea absorbida, se liberará a medida que la capa 37 es absorbida.
Mientras que tanto la barrera de adhesión 20 como la capa 37 son absorbidas por el cuerpo de un paciente, la capa 33 de la prótesis quirúrgica 10 se incorpora en la pared 110. La capa 33, hecha sustancialmente de hilo no biodegradable 34, proporciona una estructura macroporosa sólida que permite el crecimiento de tejido (por ejemplo, la capa 33 tiene un tamaño de poro de 100 micrómetros o mayor) para reparar la abertura 100.
En general, la prótesis quirúrgica 10 se puede preparar usando cualquier procedimiento deseado. En ciertas realizaciones, la prótesis quirúrgica 10 se prepara como sigue. En primer lugar, la malla tridimensional 30 se crea usando hilo biodegradable 32 e hilo no biodegradable 34. Los hilos 32, 34 están enhebrados en una máquina de tejer industrial, tal como una máquina de tejer de barra con doble aguja. Los hilos 32 y 34 se tejen juntos usando cualquier patrón de tejido que crea una estructura tridimensional macroporosa que tiene una capa biodegradable (por ejemplo, la capa 37) y una capa no biodegradable (por ejemplo, la capa 33). En ciertas realizaciones, la malla 30 se forma tejiendo juntos un hilo no biodegradable, un primer hilo biodegradable, y un segundo hilo biodegradable, en el que el hilo no biodegradable y el primer hilo biodegradable forman las capas 33 y 37, respectivamente, y el segundo hilo biodegradable une las capas 33 y 37 juntas. Para aplicar la barrera de adhesión 20 a la malla 30, se añade una formulación líquida que incluye un fotoiniciador y componentes precursores de la barrera de adhesión a una bandeja de vidrio. A continuación, la malla 30 se coloca dentro de la bandeja con el lado bioabsorbible (capa 37) orientado hacia el fondo de la bandeja (por ejemplo, la capa bioabsorbible en contacto de fluido con la formulación líquida). La formulación líquida se fotopolimeriza mediante la exposición de la bandeja a una fuente de luz que activa el fotoiniciador (por ejemplo, una fuente de luz que tiene una longitud de onda de aproximadamente 450 nm a aproximadamente 550 nm y una intensidad de aproximadamente 1 mW / cm2 a aproximadamente 100 mW / cm2). Como resultado de la fotoiniciación, se forma un hidrogel dentro de la bandeja de aproximadamente al menos una parte de la capa 37. El hidrogel se seca a continuación, de manera que la malla / hidrogel resultante tiene un contenido de humedad de menos de aproximadamente el 2% (por ejemplo, menos de aproximadamente el 1,2%, tal como aproximadamente el 0,8%). Después, la malla / hidrogel secado se esteriliza para formar la prótesis quirúrgica 10.
Se cree que el hidrogel no se forma dentro de la estructura porosa de la capa 33 durante la fotopolimerización por al menos tres motivos. En primer lugar, la cantidad de formulación líquida añadida a la bandeja de vidrio se controla para producir un hidrogel que tiene un espesor que es igual o menor que el espesor de la capa 37. Por ejemplo, se añade aproximadamente un mililitro de solución que incluye un fotoiniciador y componentes precursores de la barrera de adhesión por 6,4 cm2 de bandeja. Después, se añade a la bandeja una malla que tiene una densidad de área de 156 g / m2 con una capa biodegradable que tiene un espesor no comprimido de aproximadamente 2,5 milímetros. En segundo lugar, porque existe una incompatibilidad entre el hilo no biodegradable 34 (por ejemplo, hidrófobo) y los componentes precursores hidrófilos, la formulación líquida no tiende a subir en la estructura de poros de la capa 33. Como resultado de esto, cuando se polimeriza la formulación líquida se forma el hidrogel sólo alrededor de la capa 37. En tercer lugar, cuando el hidrogel polimerizado, que es principalmente agua, se seca al aire, disminuye en gran medida en espesor. Como resultado de esto, la barrera de adhesión solamente está alrededor de la capa 37.
Los siguientes ejemplos son ilustrativos y no pretenden ser limitantes.
Ejemplo 1
Para la fabricación de la malla tridimensional, se enhebraron dos fibras monofilamento de polipropileno de 0,127 mm (Shakespeare Monofilament y Specialty Polymers, Columbia, Carolina del Sur), una fibra multifilamento de ácido poliglicólico de 45 denier (Teleflex Medical, Coventry, CT), y una fibra multifilamento de ácido poliglicólico de 90 denier (Teleflex Medical, Coventry, CT) en una máquina de tejer de barra con doble aguja (Karl Mayer Textimaschinenfabrik GmbH, Oberlshausen, Alemania). En relación con las Figuras 2A-C, las fibras se tejieron en conjunto por Secant Medical, Perkasie, PA usando el patrón de barras que figura a continuación para crear una malla que tenía una capa formada sustancialmente de ácido poli (glicólico), delante (Fig. 2C), una capa formada sustancialmente de polipropileno, detrás (Fig. 2B), y una fibra de unión de ácido poliglicólico que conectaba las dos capas juntas (Fig. 2A).
Tabla 1: Patrón de barra de malla
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Veintiocho días después de la cirugía, los conejos fueron sacrificados y se evaluó el rendimiento general de los materiales, incluyendo la formación de adhesiones y el crecimiento de tejido. Se evaluó la formación de adhesiones y se registró visualmente la extensión de la cobertura por adhesión. Se usó la siguiente escala durante el examen visual: 0 = sin adhesiones, 1 = el 25% o menos del defecto cubierto por adhesiones, 2 = del 26% al 50%
5 del defecto cubierto por adhesión, 3 = del 51% al 75% del defecto cubierto por adhesiones, 4 = más del 75% del defecto cubierto por adhesiones.
Además de los exámenes visuales, se usó el análisis de imágenes para calcular la superficie total de los defectos y el área de superficie cubierta por adhesiones. También se recogieron y analizaron ensayos mecánicos y muestras SEM.
10 Los resultados se describen en las Tablas 2 y 3 a continuación.
Tabla 2: Resultados de la eficacia de la reducción de adhesión en la reparación de hernia de conejo con intestino abrasado
- Grupo N = 10
- Extensión media de adhesiones % Defecto con adhesiones % Animales sin adhesiones % sin adhesión densa al intestino
- Malla de polipropileno
- 2,9 ± 0,3 47,3 ± 6,3 0 0
- Prótesis quirúrgica como se prepara en el Ejemplo 3
- 1,3 ± 0,2* 14,3 ± 5,0* 0 60**
- *p < 0,05 Análisis HSD Tukey Kramer **p < 0,05 Análisis Chi-Cuadrado
Tabla 3: Resultados de la incorporación de tejido en la reparación de hernia de conejo con intestino abrasado
- Grupo
- Carga máxima (N) ± SEM
- Malla de polipropileno
- 33,7 ± 1,2
- Prótesis quirúrgica como se prepara en el Ejemplo 3
- 29,7 ± 1,3
- ^ p < 0,05 Análisis HSD Tukey Kramer
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Los resultados de la Tabla 2 indican que la prótesis quirúrgica como se describe en el Ejemplo 3 se realizó significativamente bien en la prevención de adhesiones intestinales densas in vivo. Además, la prótesis quirúrgica descrita en el Ejemplo 3 tenía una excelente resistencia a la incorporación de tejido como se muestra en la Tabla 3.
Ejemplo 5
20 Se preparó una prótesis quirúrgica colocando el lado del ácido poliglicólico bioabsorbible de la malla tal como se describe en el Ejemplo 1 en 10 a 12 ml de una formulación líquida en un plato de poliestireno que tiene un área de 56,7 centímetros cuadrados. Para la formulación líquida, se mezcló 2 gramos de HA / CMC en polvo modificada con carbodiimida en 90 gramos de agua con macrómero 20kTLA2 al 5% en 100 gramos de agua desionizada. Se añadió una solución adicional que estaba constituida por 40 ppm de eosina Y, 4,000 ppm de N-vinilcaprolactama,
25 1,08 gramos de trietanolamina, y 1,6 gramos de fosfato potásico en agua desionizada para llegar al volumen final de 200 gramos.
La formulación líquida se polimerizó después en un hidrogel usando una disposición de LED (450 -550 nm) a una intensidad de aproximadamente 4 mW / cm2 durante 45 segundos. La malla con hidrogel se secó por congelación a aproximadamente -30°C y 26,7 Pa, antes de separarla de la placa de poliestireno. La prótesis quirúrgica
30 resultante se comprimió con 22,2 kN de fuerza durante 10 segundos entre placas recubiertas con teflón y se envasó doblemente en bolsas permeables al vapor. La prótesis quirúrgica se esterilizó por exposición a óxido de etileno antes de su uso.
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de tejido de punto atlas de polipropileno con una masa / área de 9,4 mg / cm2 y hecha de fibra de polipropileno de 6 mm. La tela de fieltro no tejida de PGA se obtuvo de Scaffix Internacional (Dover, MA) y la malla de tejido de punto atlas de polipropileno se obtuvo de Genzyme Biosurgery (Fall River, MA).
La tela de fieltro no tejida se cosió a la malla de polipropileno usando un tamaño de sutura 6 – 0 de ácido poliglicólico de Bondek® (proporcionado por Genzyme Biosurgery, Coventry, CT ahora Teleflex Medical, Coventry, CT) en una máquina de coser convencional. La masa / área de la malla cuando se cosieron juntas era de 16 mg / cm2a 17 mg / cm2.
Para formar una prótesis quirúrgica, la malla se colocó con la tela de fieltro no tejida de PGA hacia abajo en 10 ml de una formulación líquida de 20kTLA2 al 2,5%, 40 ppm de eosina Y, 4.000 ppm de N-vinilcaprolactama, trietanolamina al 0,54%, y fosfato de potasio al 0,8% en un plato de poliestireno que tiene una superficie de 56,7 cm2. La formulación líquida se fotopolimerizó en un hidrogel con cinco ciclos de 40 segundos a partir de una fuente de luz de xenón. La malla con el hidrogel se secó por congelación a -30°C y 26,7 Pa. El resultado fue una muestra seca flexible, bien incorporada. La prótesis quirúrgica se esterilizó por exposición a óxido de etileno. Después de la hidratación inicial, la prótesis quirúrgica tuvo una buena durabilidad de la manipulación con humedad.
Ejemplo 9
Se formó una malla para una prótesis quirúrgica usando el procedimiento descrito en el Ejemplo 8. La parte de la tela de fieltro no tejida se colocó hacia abajo en un plato de poliestireno de 56,7 cm2 con 12 gramos de una suspensión que incluye 2,3% HA / CMC modificado por carbodiimida, tal como se obtuvo de Genzyme Corporation (Framingham, MA) y 0,073 ml de glicerol, un plastificante. El plato que incluía la suspensión y la malla se dejó secar al aire durante la noche.
Como resultado se obtuvo una muestra de material compuesto de alta calidad con todos los componentes firmemente unidos y una relación masa / área de 21,7 mg / cm2. Mediante el uso de microscopía electrónica de barrido (SEM), se observó que la membrana de HA / CMC plastificada se integraba en las fibras de la parte de la tela de fieltro no tejida de la malla. Se apreciaron algunos vacíos, posiblemente debido a las burbujas de aire, dentro de la barrera de adhesión.
La muestra se calentó durante 7 horas a 100°C en un horno de convección para eliminar la humedad residual. Tras la hidratación, la capa hidrófila lubricada de HA / CMC era visualmente perceptible en la superficie de la prótesis quirúrgica. La prótesis quirúrgica tenía buenas propiedades de manipulación con humedad después de la hidratación inicial y después de 24 horas de remojo en agua a temperatura ambiente. La muestra hidratada se podía frotar enérgicamente entre el dedo pulgar y el índice sin deslaminación y no se podía separar con la mano.
Ejemplo 10
Se formó una malla para una prótesis quirúrgica usando el procedimiento descrito en el Ejemplo 8. La parte de la tela de fieltro no tejida se colocó hacia abajo en un plato de poliestireno de 56,7 cm2 que tiene 5 ml de una solución de 20kTLA2 al 5%, 40 ppm de eosina Y, 4.000 ppm de N-vinilcaprolactama, trietanolamina al 0,54%, fosfato de potasio al 0,8%, y ácido hialurónico al 5%. La solución se fotopolimerizó después en un hidrogel con cuatro ciclos de 40 segundos a partir de una fuente de luz de xenón obtenida de Genzyme Biosurgery (Lexington, MA).
La prótesis quirúrgica tenía muy buena durabilidad de manipulación con humedad y se podría usar de esta forma o seca por congelación para usar en un momento posterior.
Ejemplo 11
Se formó una malla para una prótesis quirúrgica cosiendo una malla tejida Vicryl® formada por poliglactina 910, un copolímero de fibras de ácido poliglicólico y poliláctico y obtenido de Ethicon (New Brunswick, NJ) a una malla de tejido de punto atlas de polipropileno con una superficie de masa de 9,4 mg / cm2 y hecha de fibra de polipropileno de 6 mm y obtenida de Genzyme Biosurgery (Fall River, MA).
La malla tejida Vicryl® se cosió a la malla de polipropileno usando un tamaño de sutura 6 – 0 de ácido poliglicólico de Bondek® (proporcionado por Genzyme Biosurgery, Coventry, CT ahora Teleflex Medical, Coventry, CT) en una máquina de coser convencional. La masa / área de la malla ya cosida era de aproximadamente 15 mg / cm2.
Para formar la prótesis quirúrgica, la malla se colocó con la superficie de Vicryl® hacia abajo en 5 ml de una solución de 20kTLA2 al 5%, 40 ppm de Eosina Y, 4.000 ppm de N-vinilcaprolactama, trietanolamina al 0,54%, y potasio al 0,8% en un plato de poliestireno con un área de 56,7 cm3. La solución se fotopolimerizó después en un hidrogel con cuatro ciclos de 40 segundos de una fuente de luz de xenón. La prótesis quirúrgica se secó por congelación a -30°C y 26,7 Pa. Como resultado se obtuvo una prótesis quirúrgica, seca, flexible, bien incorporada. Después de la hidratación inicial, la prótesis quirúrgica tenía buena durabilidad de manipulación con humedad.
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PCT/US2005/012312 WO2005105172A1 (en) | 2004-04-20 | 2005-04-12 | Surgical mesh-like implant |
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ES2546393T3 true ES2546393T3 (es) | 2015-09-23 |
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ES05732926.0T Active ES2546393T3 (es) | 2004-04-20 | 2005-04-12 | Implante quirúrgico tipo malla |
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EP (1) | EP1744796B1 (es) |
JP (1) | JP4977600B2 (es) |
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-
2005
- 2005-04-12 ES ES05732926.0T patent/ES2546393T3/es active Active
- 2005-04-12 JP JP2007509511A patent/JP4977600B2/ja active Active
- 2005-04-12 WO PCT/US2005/012312 patent/WO2005105172A1/en active Application Filing
- 2005-04-12 CA CA2563347A patent/CA2563347C/en active Active
- 2005-04-12 AU AU2005237985A patent/AU2005237985B2/en active Active
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JP2007533405A (ja) | 2007-11-22 |
WO2005105172A1 (en) | 2005-11-10 |
EP1744796B1 (en) | 2015-03-18 |
CN101035574B (zh) | 2011-05-11 |
AU2011200200B2 (en) | 2011-12-22 |
AU2011200200A1 (en) | 2011-02-10 |
US20050244455A1 (en) | 2005-11-03 |
EP1744796A1 (en) | 2007-01-24 |
BRPI0510042A (pt) | 2007-10-16 |
US20130045327A1 (en) | 2013-02-21 |
AU2005237985B2 (en) | 2010-10-21 |
US8460695B2 (en) | 2013-06-11 |
CA2563347A1 (en) | 2005-11-10 |
CN101035574A (zh) | 2007-09-12 |
CA2563347C (en) | 2014-01-14 |
BRPI0510042B8 (pt) | 2021-06-22 |
AU2005237985A1 (en) | 2005-11-10 |
JP4977600B2 (ja) | 2012-07-18 |
US8323675B2 (en) | 2012-12-04 |
BRPI0510042B1 (pt) | 2017-04-25 |
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