ES2905408T3 - Sistema de retención de materiales de refuerzo entrelazados - Google Patents

Sistema de retención de materiales de refuerzo entrelazados Download PDF

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ES2905408T3
ES2905408T3 ES14168904T ES14168904T ES2905408T3 ES 2905408 T3 ES2905408 T3 ES 2905408T3 ES 14168904 T ES14168904 T ES 14168904T ES 14168904 T ES14168904 T ES 14168904T ES 2905408 T3 ES2905408 T3 ES 2905408T3
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cartridge
staple
backing material
anvil
retention system
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Megan L Prommersberger
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/10—Surgical instruments, devices or methods for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
    • A61B17/105—Wound clamp magazines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
    • A61B17/0686—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil having a forming anvil staying below the tissue during stapling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07292—Reinforcements for staple line, e.g. pledgets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00893—Material properties pharmaceutically effective
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320052—Guides for cutting instruments

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Abstract

Un sistema de retención de refuerzo del cartucho (30) para retener un material de refuerzo del cartucho (26) en un cartucho de grapas (122) antes de grapar el tejido que comprende: un material de refuerzo del cartucho (26) retenido en el cartucho de grapas (122); un cartucho de grapas (122) que incluye un canal exterior en forma de U (108) que rodea un inserto que contiene grapas (110); un poste (116) formado en un extremo distal (118) del inserto que contiene grapas (110) y configurado para acoplar el refuerzo del cartucho, y dedos o proyecciones que se extienden distalmente (124, 126) formados en un extremo proximal (128) del inserto que contiene grapas (110) configurados para acoplar el material de refuerzo del cartucho (26) en donde el material de refuerzo del cartucho (26) está provisto de ranuras correspondientes (134, 136) formadas en un extremo proximal (138) del material de refuerzo del cartucho (26) configuradas para acoplar los dedos o proyecciones (124, 126) del inserto que contiene grapas (110), caracterizado porque el poste (116) se divide en mitades (116a, 116b) para acomodar el paso de una hoja de cuchilla para cortar tejido y el material de refuerzo del cartucho (26) incluye un orificio correspondiente (120) formado en un extremo distal (122) del material de refuerzo del cartucho configurado para encajar sobre el poste (116).

Description

DESCRIPCIÓN
Sistema de retención de materiales de refuerzo entrelazados
Antecedentes
1. Campo técnico
La presente divulgación se refiere a sistemas de fijación para materiales de refuerzo de líneas de grapas. Más particularmente, la presente divulgación se refiere a sistemas para la fijación temporal de materiales de refuerzo de líneas de grapas a un yunque y un cartucho que contiene grapas de un instrumento de grapado quirúrgico.
2. Antecedentes de la técnica relacionada
Los instrumentos de grapado quirúrgico o "dispositivos de grapado", se emplean por los cirujanos para aplicar de manera secuencial o simultánea una o más filas de sujetadores, por ejemplo, grapas o sujetadores de dos partes, al tejido corporal con el fin de unir los segmentos de tejido corporal. Tales dispositivos generalmente incluyen un par de mordazas o estructuras en forma de dedos entre las cuales se coloca el tejido corporal a unir. Cuando el dispositivo de grapado se acciona, o "dispara", las barras de disparo que se mueven longitudinalmente contactan los miembros de empuje de grapas en una de las mordazas. Los miembros de empuje de grapas empujan las grapas quirúrgicas a través del tejido corporal y dentro de un yunque en la mordaza opuesta que cierra las grapas. Si se va a retirar o separar el tejido, se puede proporcionar una hoja de cuchilla en las mordazas del dispositivo para cortar el tejido entre las líneas de grapas.
Al grapar tejidos relativamente delgados o frágiles, es importante sellar eficazmente las líneas de grapas contra fugas de aire o fluido. Además, a menudo es necesario reforzar las líneas de grapas contra el tejido para evitar desgarres en el tejido o tirar de las grapas a través del tejido. Un método para prevenir desgarres o tirones implica la colocación de un material de reforzamiento de tela biocompatible, o material de "refuerzo", entre la grapa y el tejido subyacente. En este método, se coloca una capa de material de refuerzo contra el tejido y el tejido se grapa de manera convencional. En métodos más recientes, el material de refuerzo se posiciona en el propio instrumento de grapado antes de grapar el tejido. Un ejemplo ilustrativo de esto se divulga en la Patente de los Estados Unidos núm. 5,542,594 de McKean y otros. En McKean y otros, se desliza un tubo de material de refuerzo sobre la mordaza de la grapadora. A continuación, se acciona la grapadora para grapar el tejido en cuestión y asegurar el material de refuerzo entre el tejido y la línea de grapas para reforzar el tejido y la línea de grapas.
El documento US 6704210 describe una tira de sellado de bioprótesis que se retiene en las mordazas de una grapadora quirúrgica. La tira se fija a las mordazas mediante pasadores.
El documento EP 1759640 describe un dispositivo para unir un material de refuerzo a un dispositivo de sujeción quirúrgica. El refuerzo se asegura con adhesivo o con dedos formados en una pared lateral de una mordaza que retiene un inserto de yunque.
El documento US 5542594 describe un aparato de grapado quirúrgico que tiene una tela quirúrgica biocompatible unida de forma liberable a las mordazas. La unión se logra a través de tiras de tela que se pasan alrededor del costado de la mordaza.
Algunas grapadoras quirúrgicas novedosas utilizan sujetadores o prensadores para conectar temporalmente el material de refuerzo a las mordazas de las grapadoras. Sin embargo, en algunos casos, sería deseable moldear o maquinar la estructura en las propias mordazas para facilitar la fijación de materiales de refuerzo estructurados correspondientemente. Además, sería deseable proporcionar tal estructura de una manera que no interfiera con el funcionamiento de una hoja de cuchilla asociada con las mordazas.
Resumen
De acuerdo con la invención, se proporciona un sistema de refuerzo de cartucho como se indica en la reivindicación independiente. Las características preferidas de la invención se enumeran en las reivindicaciones dependientes. Se divulga una grapadora quirúrgica que tiene un par de mordazas que incluyen un cartucho de grapas y un yunque. Al menos una de las mordazas incluye al menos dos proyecciones que se extienden longitudinalmente situadas en un primer extremo de la primera mordaza. La grapadora quirúrgica también tiene un material de refuerzo de la línea de grapas fijado de forma liberable a al menos una mordaza e incluye rebajes para recibir al menos dos proyecciones. En una modalidad, cada una de las al menos dos proyecciones incluye una porción de cuello y una porción bulbosa. En una modalidad alternativa, cada una de las al menos dos proyecciones es relativamente recta. La al menos una mordaza incluye una ranura de cuchilla que se extiende longitudinalmente, estando separadas las al menos dos proyecciones por la ranura de cuchilla.
En otra modalidad, la al menos una mordaza incluye dos conjuntos de al menos dos proyecciones y la al menos una mordaza incluye una ranura de cuchilla que se extiende longitudinalmente. La ranura de cuchilla separa los dos conjuntos de al menos dos proyecciones.
En modalidades particulares, la al menos una mordaza incluye un poste en un segundo extremo y el material de refuerzo incluye un orificio para recibir el poste. En una primera versión, el poste está dividido para permitir el paso de una cuchilla entre ellos, mientras que en una segunda versión el poste es macizo.
En una modalidad específica, el poste forma una protrusión en forma de hongo que tiene una tapa y la tapa define un reborde para acoplarse con una parte del material de refuerzo.
En otra modalidad, la al menos una mordaza incluye un par de postes y el material de refuerzo incluye un par de orificios para recibir el par de postes. Cada poste del par de postes se coloca adyacente a un borde exterior del material de refuerzo. La al menos una mordaza también incluye una ranura que se extiende longitudinalmente de manera que el par de postes están separados por la ranura.
En una modalidad particular, la al menos una mordaza incluye una ranura que se extiende longitudinalmente y el poste está posicionado distalmente de un extremo distal de la ranura y el material de refuerzo tiene un orificio para recibir el poste. El material de refuerzo incluye además una hendidura longitudinal que se extiende a través del área del material de refuerzo que define el orificio.
Descripción de los dibujos
Varias modalidades de los sistemas de retención de refuerzo entrelazados actualmente divulgados se divulgan en la presente descripción con referencia a los dibujos, las Figuras 1-10 y 18-26 que son modalidades ilustrativas y las Figuras 11-17 que muestran la invención tal como se define en la reivindicación 1 adjunta, en donde:
La Figura 1 es una vista en perspectiva de un instrumento de grapado quirúrgico que incorpora modalidades de sistemas de retención para la fijación de materiales de refuerzo de la línea de grapa a un yunque y a un cartucho que contiene grapas del instrumento de grapado quirúrgico;
La Figura 2 es una vista en perspectiva ampliada del extremo distal del instrumento de grapado quirúrgico de la Figura 1;
La Figura 3 es una vista en perspectiva, con partes separadas, de una modalidad de un yunque y un sistema de retención del material de refuerzo;
La Figura 4 es una vista en perspectiva del sistema de retención del material de refuerzo del yunque ensamblado;
La Figura 5 es una vista superior del extremo distal del sistema de retención del material de refuerzo del yunque de la Figura 4;
La Figura 6 es una vista en sección transversal que se toma a lo largo de la línea 6-6 de la Figura 4;
La Figura 7 es una vista en perspectiva, con partes separadas, del extremo proximal del sistema de retención del refuerzo del yunque de la Figura 4;
La Figura 8 es una vista en sección transversal que se toma a lo largo de la línea 8-8 de la Figura 7;
La Figura 9 es una vista en perspectiva, con partes separadas, de una modalidad alternativa del extremo proximal de un sistema de retención del refuerzo del yunque;
La Figura 10 es una vista en sección transversal que se toma a lo largo de la línea 10-10 de la Figura 9; La Figura 11 es una vista en perspectiva, con partes separadas, de una modalidad de un cartucho que contiene grapas y un sistema de retención del material de refuerzo;
La Figura 12 es una vista en perspectiva del sistema de retención del refuerzo del cartucho ensamblado de la Figura 11;
La Figura 13 es una vista superior del extremo proximal del sistema de retención del refuerzo del cartucho de la Figura 12;
La Figura 14 es una vista superior de una modalidad alternativa de un extremo proximal de un sistema de retención del refuerzo del cartucho;
La Figura 15 es una vista en sección transversal que se toma a lo largo de la línea 15-15 de la Figura 12; La Figura 16 es una vista en perspectiva, con partes separadas, del extremo distal del sistema de retención del refuerzo del cartucho de la Figura 12;
La Figura 17 es una vista en sección transversal que se toma a lo largo de la línea 17-17 de la Figura 16; La Figura 18 es una vista en perspectiva, con partes separadas, de una modalidad alternativa de un extremo distal del sistema de retención del refuerzo del cartucho;
La Figura 19 es una vista en sección transversal que se toma a lo largo de la línea 19-19 de la Figura 18; La Figura 20 es una vista en perspectiva, con partes separadas, de una modalidad alternativa adicional de un extremo distal de un sistema de retención del refuerzo del cartucho;
La Figura 21 es una vista en sección transversal que se toma a lo largo de la línea 21-21 de la Figura 20; La Figura 22 es una vista en perspectiva del extremo distal del instrumento de grapado quirúrgico de la Figura 1 colocado alrededor de una sección de tejido;
La Figura 23 es una vista lateral, parcialmente mostrada en sección, del extremo distal del instrumento de grapado quirúrgico colocado alrededor de la sección de tejido;
La Figura 24 es una vista lateral, parcialmente mostrada en sección, durante el accionamiento inicial del instrumento de grapado quirúrgico de la Figura 1;
La Figura 25 es una vista en perspectiva de la sección de tejido grapado y dividido; y
La Figura 26 es una vista en sección transversal que se toma a lo largo de la línea 26-26 de la Figura 25. Descripción detallada de las modalidades
Las modalidades de los sistemas de retención de material de refuerzo entrelazado divulgados en la presente para su uso con instrumentos de grapado quirúrgico, se describirán ahora en detalle con referencia a los dibujos, en los que, los numerales similares designan elementos idénticos o correspondientes en cada una de las diversas vistas. Como es común en la técnica, el término "proximal" se refiere a esa parte o componente más cercano al usuario u operador, es decir, cirujano o médico, mientras que el término "distal" se refiere a esa parte o componente más alejado del usuario.
Con referencia ahora a la Figura 1, se divulga un instrumento de grapado quirúrgico lineal o una grapadora quirúrgica 10 para su uso en el grapado de tejido y la aplicación de capas de material de refuerzo entre las grapas y el tejido subyacente. Un ejemplo ilustrativo de este tipo de instrumento de grapado quirúrgico se divulga en la Patente de los Estados Unidos número 7,128,253. La grapadora quirúrgica 10 generalmente incluye un mango 12 que tiene un miembro tubular alargado 14 que se extiende distalmente desde el mango 12. Un conjunto de mordaza 16 se monta en un extremo distal 18 del miembro tubular alargado 14. El conjunto de mordaza 16 incluye un yunque de remachado de grapas 20 y un cartucho que contiene grapas o cartucho de grapas 22. El cartucho de grapas 22 puede fijarse permanentemente al miembro tubular alargado 14 o puede ser desmontable y, por lo tanto, reemplazable con un nuevo cartucho de grapas 22. El yunque de remachado de grapas 20 se monta de forma móvil en el extremo distal 18 del miembro tubular alargado 14 y puede moverse entre una posición abierta separada del cartucho de grapas 22 a una posición cerrada sustancialmente adyacente al cartucho de grapas 22.
El yunque de remachado de grapas 20 se proporciona con una capa de material de refuerzo del yunque 24 y el cartucho de grapas 22 se proporciona con una capa de material de refuerzo del cartucho 26 en las formas que se describen con más detalle a continuación. Un sistema de retención del refuerzo del yunque 28 se incorpora en el yunque 20 y el material de refuerzo del yunque 24 y se proporciona para asegurar de forma liberable el material de refuerzo del yunque 24 al yunque de remachado de grapas 20. Asimismo, un sistema de retención del refuerzo del cartucho 30 incorporado en el cartucho de grapas 22 y el material de refuerzo del cartucho 26, se proporciona para asegurar de manera liberable el material de refuerzo del cartucho 26 al cartucho de grapas 22. El material de refuerzo del yunque 24 y el material de refuerzo del cartucho 26 se proporcionan para reforzar y sellar las líneas de grapas aplicadas al tejido por la grapadora quirúrgica 10.
El sistema de retención del refuerzo del yunque 28 y el sistema de retención del refuerzo del cartucho 30 se configuran particularmente para permitir que los respectivos materiales de refuerzo se ubiquen en las superficies orientadas hacia adentro del yunque 20 y el cartucho de grapas 22 para facilitar el paso de la grapadora quirúrgica 10 dentro del cuerpo de un paciente sin riesgo de desgarramiento o arrugamiento de los respectivos materiales de refuerzo cuando la grapadora quirúrgica 10 se inserta y se manipula dentro del cuerpo de un paciente.
La grapadora quirúrgica 10 incluye además un gatillo 32 que se monta de forma móvil en el mango 12. El accionamiento del gatillo 32 opera inicialmente para mover el yunque 20 desde la posición abierta a la cerrada con relación al cartucho de grapas 22 y, posteriormente, acciona la grapadora quirúrgica 10 para aplicar líneas de grapas al tejido. Para orientar correctamente el conjunto de mordaza 16 con respecto al tejido a grapar, la grapadora quirúrgica 10 se proporciona adicionalmente con una perilla de rotación 34 que se monta en el mango 12. La rotación de la perilla de rotación 34 con respecto al mango 12 hace girar el miembro tubular alargado 14 y el conjunto de mordaza 16 con respecto al mango 12 para orientar adecuadamente el conjunto de mordaza 16 con respecto al tejido a grapar.
Con referencia a las Figuras 1 y 2, se proporciona un impulsor 36 para mover el yunque 20 entre las posiciones abierta y cerrada con respecto al cartucho de grapas 22. El impulsor 36 se mueve entre una ranura longitudinal 38 que se forma en el yunque 20. Una hoja de cuchilla (no mostrada) se asocia con el impulsor 32 para cortar el tejido capturado entre el yunque 20 y el cartucho de grapas 22 cuando el impulsor 36 pasa a través de la ranura 38.
Con referencia a la Figura 3, para mover el yunque 20 entre las posiciones abierta y cerrada, el yunque 20 incluye un borde 40 proximal, en ángulo o inclinado que se configura para ser acoplado por el impulsor 36 con el fin de mover el yunque 20 a la posición cerrada. La ranura 38 se extiende distalmente desde el borde inclinado 40 y termina en una ranura transversal 42 que se configura para capturar el impulsor 36 tras el accionamiento completo de la grapadora quirúrgica 10 para evitar cualquier accionamiento adicional de la grapadora quirúrgica 10. Para asegurar las grapas proporcionadas por el cartucho de grapas 22 alrededor de los tejidos y los materiales de refuerzo, el yunque 20 se proporciona con filas de cavidades de remachado de grapas 44 que se extienden longitudinalmente, ubicadas a cada lado de la ranura longitudinal 38.
Con referencia todavía a la Figura 3, se describirá ahora el sistema de retención del refuerzo del yunque 28, incorporado en el yunque 20 y el material de refuerzo del yunque 24. El material de refuerzo del yunque 24, así como el material de refuerzo del cartucho 26. El material de refuerzo para el cartucho de grapas 22 y/o el yunque 20 pueden hacerse de cualquier material natural o sintético biocompatible. El material a partir del cual se forma el material de refuerzo puede ser bioabsorbible o no bioabsorbible. Debe entenderse por supuesto que cualquier combinación de materiales naturales, sintéticos, bioabsorbibles y no bioabsorbibles puede usarse para formar el material de refuerzo.
Algunos ejemplos no limitantes de materiales a partir de los cuales se puede hacer el material de refuerzo incluyen, pero no se limitan a, poli (ácido láctico), poli (ácido glicólico), poli (hidroxibutirato), poli (fosfazina), poliésteres, polietilenglicoles, óxidos de polietileno, poliacrilamidas, polihidroxiethilmetilacrilato, polivinilpirrolidona, alcoholes de polivinilo, ácido poliacrílico, poliacetato, policaprolactona, polipropileno, poliésteres alifáticos, gliceroles, poli (aminoácidos), copoli (éter-ésteres), oxalatos de polialquileno, poliamidas, poli (iminocarbonatos), oxalatos de polialquileno, polioxaésteres, poliortoésteres, polifosfacenos y copolímeros, copolímeros de bloque, homopolímeros, mezclas y sus combinaciones.
En las modalidades, se usan polímeros biológicos naturales para formar el material de refuerzo. Los polímeros biológicos naturales adecuados incluyen, pero no se limitan a colágeno, gelatina, fibrina, fibrinógeno, elastina, queratina, albúmina, hidroxietilcelulosa, celulosa, hidroxipropilcelulosa, carboxietilcelulosa, quitan, quitosano, y sus combinaciones. Además, los polímeros biológicos naturales pueden combinarse con cualquiera de los otros materiales poliméricos descritos en el presente documento para producir el material de refuerzo.
El material de refuerzo puede ser poroso o no poroso, o combinaciones de capas porosas y no porosas. Cuando el material de refuerzo es no poroso, el material de refuerzo puede retardar o evitar el crecimiento hacia adentro de tejidos circundantes, actuando de esta manera como una barrera de adhesión y evitando la formación de tejido cicatricial no deseado. Por lo tanto, en las modalidades, el material de refuerzo posee propiedades antiadherentes. Las técnicas para formar capas no porosas a partir de dichos materiales están dentro del alcance de los expertos en la técnica e incluyen, por ejemplo, fundición, moldeo y similares.
En las modalidades, el material de refuerzo es poroso y posee propiedades hemostáticas. Cuando el material de refuerzo es poroso, tiene aberturas o poros sobre al menos una porción de una superficie del mismo. Los materiales adecuados para formar la capa porosa incluyen, pero no se limitan a, espumas (por ejemplo, espumas de celdas abiertas o cerradas). En las modalidades, los poros pueden tener un número y un tamaño suficientes para interconectarse a través del grosor completo de la capa porosa. En otras modalidades, los poros no se interconectan a través del grosor completo de la capa porosa. En aún otras modalidades, los poros no se extienden a través del grosor completo de la capa porosa, sino que están presentes en una porción de la superficie de la misma. En las modalidades, las aberturas o poros se ubican en una porción de la superficie de la capa porosa, con otras porciones de la capa porosa que tienen una textura no porosa. Los expertos en la técnica que lean la presente divulgación visualizarán otros patrones de distribución de poros y configuraciones para la capa porosa.
Cuando el material de refuerzo es poroso, los poros se pueden formar mediante el uso de cualquier método adecuado para formar una espuma o esponja que incluye, pero no se limita a, la liofilización o congelación-secado de una composición. Las técnicas adecuadas para fabricar espumas están dentro del alcance de los expertos en la técnica. Los materiales de refuerzo porosos pueden tener al menos 0,2 cm de grosor, en las modalidades de aproximadamente 0,3 a aproximadamente 1,5 cm de grosor. Los materiales de refuerzo porosos pueden tener una densidad de no más de aproximadamente 75 mg/cm2 y, en las modalidades por debajo de aproximadamente 20 mg/cm2. El tamaño de los poros en los materiales de refuerzo porosos puede ser de aproximadamente 20 pm a aproximadamente 300 pm, en las modalidades de aproximadamente 100 pm a aproximadamente 200 pm.
El material de refuerzo también puede incluir un miembro de reforzamiento. El miembro de reforzamiento puede asociarse con una capa porosa o no porosa o puede colocarse entre una capa no porosa y una capa porosa del material de refuerzo. Alternativamente, el miembro de reforzamiento puede colocarse completamente dentro de una o más de las capas individuales (es decir, incrustado dentro de la capa porosa, la capa no porosa, o ambas) del material de refuerzo. También se visualiza que el miembro de reforzamiento pueda colocarse en la superficie de una de las capas que forman el material de refuerzo y, en las modalidades, se pueda colocar en una superficie exterior del material de refuerzo.
Algunos ejemplos no limitantes adecuados de los miembros de reforzamiento incluyen telas, mallas, monofilamentos, trenzas multifilamento, fibras cortadas (a veces referidas en la técnica como fibra corta) y sus combinaciones. Cuando el miembro de reforzamiento es una malla, se puede preparar mediante el uso de cualquier técnica conocida por los expertos en la técnica, tal como tejido de punto, tejedura, encaje, nudo o similares. Cuando se usan monofilamentos o trenzas multifilamento como el miembro de reforzamiento, los monofilamentos o trenzas multifilamento pueden orientarse de cualquier manera deseada. Por ejemplo, los monofilamentos o trenzas multifilamento pueden posicionarse aleatoriamente entre sí dentro del material de refuerzo. Como otro ejemplo, los monofilamentos o trenzas multifilamentos pueden orientarse en una dirección común dentro del material de refuerzo. Cuando se usan fibras cortadas como el miembro de reforzamiento, las fibras cortadas pueden orientarse de cualquier manera deseada. Por ejemplo, las fibras cortadas pueden orientarse aleatoriamente o pueden orientarse en una dirección común. Las fibras cortadas pueden por lo tanto formar un material no tejido, tal como una esterilla o un fieltro. Las fibras cortadas pueden unirse entre sí (por ejemplo, mediante fusión por calor) o pueden soltarse entre sí. Las fibras cortadas pueden ser de cualquier longitud adecuada. Por ejemplo, el corte puede ser de 0,1 mm a 100 mm de longitud, en las modalidades, de 0,4 mm a 50 mm de longitud. En una modalidad ilustrativa, el material de refuerzo tiene fibras cortadas orientadas aleatoriamente que no se han fusionado previamente, incrustadas dentro del material de refuerzo.
Se visualiza que el miembro de reforzamiento pueda formarse a partir de cualquier material bioabsorbible, no bioabsorbible, natural, o sintético descrito previamente en el presente documento y sus combinaciones. Cuando se usan monofilamentos o trenzas multifilamento como el miembro de reforzamiento, cualquier material de sutura disponible comercialmente puede emplearse ventajosamente como el miembro de reforzamiento.
En las modalidades, al menos un agente bioactivo puede combinarse con el material de refuerzo y/o cualquiera de los componentes individuales (la capa porosa, la capa no porosa y/o el miembro de reforzamiento) que se usan para construir el material de refuerzo. En estas modalidades, el material de refuerzo también puede servir como vehículo para la administración del agente bioactivo. El término "agente bioactivo", como se usa en el presente documento, se usa en su sentido más amplio e incluye cualquier sustancia o mezcla de sustancias que tienen un uso clínico. En consecuencia, los agentes bioactivos pueden o no tener actividad farmacológica per se, por ejemplo, un tinte o fragancia. Alternativamente, un agente bioactivo podría ser cualquier agente que proporcione un efecto terapéutico o profiláctico, un compuesto que afecte o participe en el crecimiento de tejidos, el crecimiento de células, la diferenciación de células, un compuesto antiadhesivo, un compuesto que puede invocar una acción biológica tal como una respuesta inmune, o podría desempeñar cualquier otro papel en uno o más procesos biológicos.
Los ejemplos de clases de agentes bioactivos que pueden utilizarse de acuerdo con la presente divulgación incluyen antiadhesivos, antimicrobianos, analgésicos, antipiréticos, anestésicos, antiepilépticos, antihistamínicos, antiinflamatorios, fármacos cardiovasculares, agentes de diagnóstico, simpatomiméticos, colinomiméticos, antimuscarínicos, antiespasmódicos, hormonas, factores de crecimiento, relajantes musculares, bloqueadores de las neuronas adrenérgicas, antineoplásicos, agentes inmunogénicos, inmunosupresores, fármacos gastrointestinales, diuréticos, esteroides, lípidos, lipopolisacáridos, polisacáridos y enzimas. También se pretende que puedan usarse combinaciones de agentes bioactivos.
Pueden usarse agentes antiadhesivos o antiadhesión para, evitar que se formen adherencias entre el material de refuerzo y los tejidos circundantes opuestos al tejido tratado. Algunos ejemplos de estos agentes incluyen, entre otros, poli (vinilpirrolidona), carboximetilcelulosa, ácido hialurónico, óxido de polietileno, alcoholes polivinílicos y sus combinaciones.
Los agentes antimicrobianos adecuados que pueden incluirse como agente bioactivo en el material de refuerzo de la presente divulgación incluyen triclosán, también conocido como 2,4,4'-tricloro-2'-hidroxidifenil éter, clorhexidina y sus sales, incluyendo acetato de clorhexidina, gluconato de clorhexidina, clorhidrato de clorhexidina y sulfato de clorhexidina, plata y sus sales, incluidos acetato de plata, benzoato de plata, carbonato de plata, citrato de plata, yodato de plata, yoduro de plata, lactato de plata, laurato de plata, nitrato de plata, óxido de plata, palmitato de plata, proteína de plata y sulfadiazina de plata, polimixina, tetraciclina, aminoglucósidos, tales como tobramicina y gentamicina, rifampicina, bacitracina, neomicina, cloranfenicol, miconazol, quinolonas, como ácido oxolínico, norfloxacina, ácido nalidíxico, pefloxacina, enoxacina y ciprofloxacina, penicilinas tales como oxacilina y pipracil, nonoxinol 9, ácido fusídico, cefalosporinas y sus combinaciones. Además, las proteínas y péptidos antimicrobianos tales como la lactoferrina bovina y la lactoferricina B pueden incluirse como agente bioactivo en el recubrimiento bioactivo de la presente divulgación.
Otros agentes bioactivos que pueden incluirse como agente bioactivo en el material de refuerzo de acuerdo con la presente divulgación incluyen: anestésicos locales; agentes antifertilidad no esteroideos; agentes parasimpaticomiméticos; agentes psicoterapéuticos; tranquilizantes; descongestionantes; hipnóticos sedantes; esteroides; sulfonamidas; agentes simpaticomiméticos; vacunas; vitaminas; antipalúdicos; agentes antimigraña; agentes antiparkinsonianos tales como L-dopa; antiespasmódicos; agentes anticolinérgicos (por ejemplo, oxibutinina); antitusivos; broncodilatadores; agentes cardiovasculares tales como vasodilatadores coronarios y nitroglicerina; alcaloides; analgésicos; narcóticos tales como codeína, dihidrocodeinona, meperidina, morfina y similares; no narcóticos tales como salicilatos, aspirina, acetaminofeno, d-propoxifeno y similares; antagonistas de los receptores de opioides, tales como la naltrexona y la naloxona; agentes anticancerígenos; anticonvulsivos; antieméticos; antihistamínicos; agentes antiinflamatorios tales como agentes hormonales, hidrocortisona, prednisolona, prednisona, agentes no hormonales, alopurinol, indometacina, fenilbutazona y similares; prostaglandinas y fármacos citotóxicos; estrógenos; antibacterianos; antibióticos; antifúngicos; antivirales; anticoagulantes; anticonvulsivos; antidepresivos; antihistamínicos; y agentes inmunológicos.
Otros ejemplos de agentes bioactivos adecuados que pueden incluirse en la composición de recubrimiento incluyen virus y células; péptidos, polipéptidos y proteínas, análogos, muteínas y fragmentos activos de las mismas, tales como inmunoglobulinas, anticuerpos, citocinas (por ejemplo, linfocinas, monocinas, quimiocinas), factores de coagulación de la sangre, factores hemopoyéticos, interleucinas (IL-2, IL-3, IL-4, IL-6), interferones (p-IFN, (a-IFN y Y-IFN), eritropoyetina, nucleasas, factor de necrosis tumoral, factores estimulantes de colonias (por ejemplo, GCSF, GM-CSF, MCSF), insulina, agentes antitumorales y supresores de tumores, proteínas de la sangre, gonadotropinas (por ejemplo, FSH, LH, CG, etc.), hormonas y análogos hormonales (por ejemplo, hormona de crecimiento), vacunas (por ejemplo, antígenos tumorales, bacterianos y virales); somatostatina; antígenos; factores de coagulación de la sangre; factores de crecimiento (por ejemplo, factor de crecimiento nervioso, factor de crecimiento insulínico); inhibidores de proteínas, antagonistas de proteínas y agonistas de proteínas; ácidos nucleicos tales como moléculas antisentido, ADN y ARN; oligonucleótidos; polinucleótidos y ribozimas.
Se proporciona un sistema de retención del refuerzo del yunque 28 para asegurar de forma liberable el material de refuerzo del yunque 24 al yunque 20 antes de grapar al tejido. El sistema de retención del refuerzo del yunque 28 incluye una región que se eleva distalmente 46 formada en una superficie inferior 48 del yunque 20. Como se muestra mejor en las Figuras 3 y 5, la región que se eleva distalmente 46 incluye un par de dedos o proyecciones 50 y 52 que se extienden proximalmente que se configuran para asegurar de forma liberable un extremo distal del material de refuerzo del yunque 24 en el yunque 20. Como se usa en la presente descripción, el término "proyecciones" se refiere a aquellas estructuras que se proporcionan en las mordazas del instrumento que se asemejan a dedos y se configuran para acoplarse con el material de refuerzo colocado entre los dedos en forma de ajuste por fricción. Las proyecciones 50 y 52 incluyen cuellos respectivos 54, 56 y porciones bulbosas 58, 60 que se extienden proximalmente desde los cuellos 54 y 56. Se proporcionan los cortes 62 y 64 en un extremo distal 66 del material de refuerzo 24 para acoplarlo con las proyecciones 50 y 52 del yunque 20. Los cortes 62 y 64 se configuran con los cuellos respectivos 68, 70 y las porciones bulbosas 72 y 74 que corresponden a los cuellos 54, 56 y las porciones bulbosas 58, 60 del yunque 20. Las proyecciones 50 y 52 junto con los cortes 62 y 64 forman pares de dedos entrelazados para sujetar el material de refuerzo del yunque 24 en el yunque 20.
El sistema de retención del refuerzo del yunque 28 incluye además un poste 76 que se forma en un extremo proximal 78 del yunque 20. El material de refuerzo del yunque 24 se proporciona con un orificio 80 en un extremo proximal 82 que se configura para acoplarse al poste 76 y mantener el material de refuerzo del yunque 24 tenso a través de la superficie inferior 48 del yunque 20.
Como se muestra mejor en las Figuras 3-6, el poste 76 se divide en las mitades de poste 76a y 76b que definen un canal 84 entre ellas. El canal 84 corresponde a la ranura 38 en el yunque 20 y permite el movimiento del impulsor 36, así como de la cuchilla asociada con el impulsor 36, a través de la ranura 38 para cerrar el yunque 20 y cortar el material de refuerzo del yunque 24 por la mitad después del grapado.
Con referencia de vuelta por el momento a las Figuras 3 y 4, para ensamblar el material de refuerzo del yunque 24 al yunque 20 usando el sistema de retención del refuerzo del yunque 28, los cortes 62 y 64 en el extremo distal 66 del material de refuerzo del yunque 24 se colocan sobre las proyecciones 50 y 52 en la región que se eleva distalmente 46 del yunque 20. A continuación, el material de refuerzo del yunque 24 se tensa proximalmente y el orificio 80 se coloca sobre el poste 76 en el extremo proximal 78 del yunque 20 para asegurar el material de refuerzo del yunque 24 contra la superficie inferior 48 del yunque 20.
Con referencia a las Figuras 7 y 8, se divulga una modalidad alternativa de un sistema de retención 86 para asegurar el extremo proximal 82 del material de refuerzo del yunque 24 al yunque 20 de manera que permita el paso del impulsor 36 a través de la ranura 38 en el yunque 20. El sistema de retención 86 incluye un poste o protrusión 88 en forma de hongo que tiene una tapa agrandada 90 que se coloca a través del orificio 80 en el material de refuerzo del yunque 24. La tapa 90 define una superficie inferior o brida 92 que se configura para acoplarse con el material de refuerzo del yunque 24. De manera similar al poste 76 descrito anteriormente, la protrusión 88 se divide en mitades de protrusión 88a y 88b que definen una ranura 94 entre ellas para el paso del impulsor 36 y una hoja de cuchilla asociada. La tapa 90 ayuda a impedir la liberación prematura del extremo proximal 82 del material de refuerzo del yunque 24. Aunque no se muestra específicamente, el área alrededor del orificio 80 puede incluir un área perforada para facilitar la separación del material de refuerzo del yunque 24 de la protrusión 88.
Con referencia a las Figuras 9 y 10, se ilustra otra modalidad alternativa de un sistema de retención 94 para retener el extremo proximal 82 del material de refuerzo del yunque 24 en el yunque 20. El yunque 20 se proporciona con un par de postes 96 y 98 separados horizontalmente colocados a cada lado de la ranura 38. El extremo proximal 82 del material de refuerzo del yunque 24 se proporciona con un par de orificios correspondientes 100 y 102 que se configuran para acoplarse con los postes 96 y 98, respectivamente. Los postes 96 y 98 ubican el área que asegura el material de refuerzo del yunque 24 hacia fuera de la ranura 38 en el yunque 20. Esto ayuda a mantener tensos los bordes exteriores 104 y 106 del material de refuerzo del yunque 24 durante el uso de la grapadora quirúrgica 10. Con referencia ahora a las Figuras 11 y 12, se describirá ahora el sistema de retención del refuerzo del cartucho 30. Como se indicó anteriormente, el sistema de retención del refuerzo del cartucho 30 se proporciona para retener el material de refuerzo del cartucho 26 en el cartucho de grapas 22 antes de grapar el tejido. El cartucho de grapas 22 incluye generalmente un canal exterior en forma de U 108 que rodea un inserto que contiene grapas 110. El inserto que contiene grapas 110 se proporciona con filas de cavidades de grapas 112, cuya función se describe con más detalle a continuación. Un canal de cuchilla 114 pasa longitudinalmente a través del inserto que contiene grapas 110 entre las filas de cavidades de grapas 12.
Con referencia por el momento a las Figuras 11 y 15, el sistema de retención del refuerzo del cartucho 30 incluye un poste 116 que se forma en un extremo distal 118 del inserto que contiene grapas 110. El poste 116 es similar al poste 76 descrito anteriormente y se divide en las mitades 116a y 116b para acomodar el paso de una hoja de cuchilla para cortar el tejido y el material de refuerzo del cartucho 26. El material de refuerzo del cartucho 26 incluye un orificio correspondiente 120 que se forma en un extremo distal 122 del material de refuerzo del cartucho y que se configura para encajar en el poste 116 sobre el inserto que contiene grapas 110.
Volviendo a las Figuras 11 y 12, y con respecto a la Figura 13, el sistema de retención del refuerzo del cartucho 30 incluye además un par de dedos o proyecciones 124 y 126 espaciados y relativamente rectos que se extienden distalmente formados en un extremo proximal 128 del inserto que contiene grapas 110. Las proyecciones 124 y 126 se colocan a ambos lados del canal de cuchilla 114 para asegurar el material de refuerzo del cartucho 26 adyacentes a los bordes exteriores 130 y 132 del material de refuerzo del cartucho 26. El material de refuerzo del cartucho 26 se proporciona con las ranuras correspondientes 134 y 136 que se forman en un extremo proximal 138 del material de refuerzo del cartucho 26. Las ranuras 134 y 136 se configuran para acoplarse a las proyecciones 124 y 126 del inserto que contiene grapas 110 en forma de ajuste por fricción para retener el extremo proximal 138 del material de refuerzo del cartucho 26 en el extremo proximal 128 del inserto que contiene grapas 110.
Para ensamblar el sistema de retención del refuerzo del cartucho 30, el orificio 120 en el material de refuerzo del cartucho 26 se coloca sobre la protrusión 116 en el extremo distal 118 del inserto que contiene grapas 110. A continuación, el extremo proximal 138 del material de refuerzo del cartucho 26 se coloca sobre el extremo proximal 128 del inserto que contiene grapas 110. Las ranuras 134 y 136 en el material de refuerzo del cartucho 26 se fuerzan sobre las proyecciones 124 y 126 en el inserto que contiene grapas 110 para acoplar el material de refuerzo del cartucho 26 con el inserto que contiene grapas 110 en forma de ajuste por fricción.
Con referencia por el momento a la Figura 14, en una modalidad alternativa, el extremo proximal 128 del inserto que contiene grapas 110 se proporciona con múltiples conjuntos de dedos o proyecciones 140, 142 y 144, 146 que se colocan a cada lado del canal de cuchilla 114. Las proyecciones 140, 142 y 144, 146 se acoplan a los conjuntos correspondientes de ranuras 148, 150 y 152, 154, respectivamente, para asegurar el extremo proximal 138 del material de refuerzo del cartucho 26 al extremo proximal 128 del inserto que contiene grapas 110. Al proporcionar múltiples conjuntos de dedos en la mordaza y las ranuras correspondientes en el material de refuerzo, se aumenta el área de superficie disponible para el contacto por fricción, proporcionando una conexión más segura. Aunque no se muestra específicamente, se pueden proporcionar más de dos conjuntos de dedos y ranuras en dependencia de la naturaleza del material de refuerzo y la cantidad de contacto por fricción requerido.
Con referencia ahora a las Figuras 16-21, e inicialmente con respecto a las Figuras 16 y 17, se describirán ahora métodos alternativos para asegurar de forma liberable el material de refuerzo a una mordaza de un instrumento quirúrgico. Una protrusión dividida 156, similar a la protrusión 88 descrita anteriormente, se forma en un extremo distal 118 del inserto que contiene grapas 110 e incluye las mitades de tapa 158a y 158b que definen las bridas 160a y 160b. El orificio 120, en el extremo distal 122 del material de refuerzo del cartucho 26, se ajusta sobre la protrusión dividida 156 para asegurar el extremo distal 122 del material de refuerzo del cartucho 26 al extremo distal 118 del inserto que contiene grapas 110.
Con referencia a las Figuras 18 y 19, los extremos distales 118 y 120 del inserto que contiene grapas 110 y el material de refuerzo del cartucho 26 se pueden proporcionar con postes separados 162, 164 y orificios separados 166, 168, respectivamente. Los postes 162, 164 y los orificios 166, 168 funcionan sustancialmente de manera idéntica a los postes 96, 98 y los orificios 100, 102, descritos anteriormente, para asegurar el extremo distal 122 del material de refuerzo del cartucho 26 al extremo distal 118 del inserto que contiene grapas 110.
Con respecto a las Figuras 20 y 21, un poste sólido no dividido 170, se proporciona en el extremo distal 118 del inserto que contiene grapas 110. El poste 170 se ubica de forma distal de un extremo distal 172 del canal de cuchilla 114. Se proporciona un orificio 174 en el extremo distal 120 del material de refuerzo del cartucho 26 y se forma una hendidura longitudinal 176 a través del área que define el orificio 174. En uso, una cuchilla que se asocia con la grapadora quirúrgica 10 corta completamente el material de refuerzo del cartucho 26 a lo largo del canal de cuchilla 114. Una vez que el material de refuerzo del cartucho 26 se ha grapado al tejido y se ha cortado casi por completo por la mitad, la hendidura longitudinal 176 permite que el material de refuerzo del cartucho 26 se separe por la mitad sin que se desgarre o enganche.
Con referencia ahora a las Figuras 22 a 26, e inicialmente con respecto a las Figuras 22 y 23, se describirá ahora el uso de la grapadora quirúrgica 10 para grapar y dividir una sección T de tejido tubular. Inicialmente, el conjunto de mordaza 16, que incluye el yunque 20 y el cartucho que contiene grapas 22, se colocan alrededor del tejido T que se va a grapar. El impulsor 36 está en una posición proximal con respecto a la ranura 38 del yunque. Como se muestra mejor en la Figura 23, el inserto que contiene grapas 110 incluye grapas 178 colocadas dentro de las cavidades de grapas individuales 180 de la fila de cavidades de grapas 112. Las grapas 178 son de tipo convencional e incluyen un tramo posterior 182 que tiene un par de patas 184 y 186 que se extienden desde el tramo posterior 182. Las patas 184 y 186 terminan en las puntas penetrantes de tejido 188 y 190. Los empujadores 192 se ubican dentro de las cavidades de grapas 180 y se posicionan entre las grapas 178 y la trayectoria de una barra de empuje 194.
Con referencia ahora a la Figura 24, la grapadora quirúrgica 10 se acciona inicialmente mediante el movimiento del gatillo 32 respecto al mango 12 (Figura 1) haciendo que el impulsor 36 se mueva en la dirección de la flecha B y contra el borde inclinado 40 del yunque 20 dando lugar a que el yunque 20 se mueva a la posición cerrada con respecto al cartucho de grapas 22. A medida que la barra de empuje 194 avanza distalmente dentro del inserto que contiene grapas 110, la barra de empuje 194 impulsa a los empujadores 192 hacia arriba contra los tramos posteriores 182 de las grapas 178 empujando las grapas 178 a través del material de refuerzo del cartucho 26, el tejido T, el material de refuerzo del yunque 24 y hacia las cavidades de remachado de grapas 44 en el yunque 20. Las puntas penetrantes de tejido 188 y 190 se doblan dentro de las cavidades de remachado de grapas 44 en el yunque 20 para asegurar de ese modo el material de refuerzo del yunque 24 contra el tejido T mientras que el tramo posterior 182 asegura el material de refuerzo del cartucho 26 contra el tejido T.
Aunque no se muestra específicamente, tras el accionamiento completo de la grapadora quirúrgica 10, una hoja de cuchilla asociada con la grapadora quirúrgica 10 y trasladada por el impulsor 36 corta el tejido T, así como el material de refuerzo del yunque 24 y el material de refuerzo del cartucho 26 entre las filas de grapas 102 ahora remachadas. Tras el movimiento del yunque 20 a la posición abierta separada del cartucho de grapas 22, el material de refuerzo del yunque 24 se separa del yunque 20 y el material de refuerzo del cartucho 26 se separa del cartucho de grapas 22. Específicamente, el extremo distal 122 del material de refuerzo del cartucho 26 se corta completamente por la cuchilla y se libera del poste 116. El extremo proximal 138 del material de refuerzo del cartucho 26 se libera de las proyecciones longitudinales 124, 126 en el extremo proximal 128 del inserto que contiene grapas 110. Asimismo, el extremo distal 66 del material de refuerzo del yunque 24 se libera de las proyecciones 50, 52 que se extienden proximalmente y el extremo proximal 82 del material de refuerzo del yunque 24 se libera del poste 78.
El tejido T resultante, dividido y cerrado con grapas 178, se ilustra mejor en las Figuras 25 y 26. Específicamente, el material de refuerzo del cartucho 26 se asegura contra el tejido T por los tramos posteriores 182 de las grapas 178 y el material de refuerzo del yunque 24 se asegura contra el tejido T por las puntas penetrantes de tejido 188 y 190 de las grapas 178 ahora remachadas. De esta manera, el material de refuerzo del yunque 24 y el material de refuerzo del cartucho 26 se grapan al tejido T sellando y reforzando así estas líneas de grapas creadas por las grapas 178.
Se comprenderá que pueden hacerse diversas modificaciones a las modalidades divulgadas en el presente documento. Por ejemplo, pueden proporcionarse varios números de dedos o proyecciones entrelazados para aumentar el contacto por fricción entre una mordaza y un material de refuerzo asociado. Además, los materiales de refuerzo divulgados pueden proporcionarse con varias regiones perforadas para facilitar su liberación de los dedos o proyecciones y postes descritos. Por lo tanto, la descripción anterior no debe ser interpretada como limitante, sino meramente como ejemplificaciones de modalidades particulares. Los expertos en la técnica visualizarán otras modificaciones dentro del alcance de las reivindicaciones adjuntas a la misma.

Claims (6)

  1. REIVINDICACIONES
    1 Un sistema de retención de refuerzo del cartucho (30) para retener un material de refuerzo del cartucho (26) en un cartucho de grapas (122) antes de grapar el tejido que comprende:
    un material de refuerzo del cartucho (26) retenido en el cartucho de grapas (122);
    un cartucho de grapas (122) que incluye un canal exterior en forma de U (108) que rodea un inserto que contiene grapas (110);
    un poste (116) formado en un extremo distal (118) del inserto que contiene grapas (110) y configurado para acoplar el refuerzo del cartucho, y
    dedos o proyecciones que se extienden distalmente (124, 126) formados en un extremo proximal (128) del inserto que contiene grapas (110) configurados para acoplar el material de refuerzo del cartucho (26) en donde el material de refuerzo del cartucho (26) está provisto de ranuras correspondientes (134, 136) formadas en un extremo proximal (138) del material de refuerzo del cartucho (26) configuradas para acoplar los dedos o proyecciones (124, 126) del inserto que contiene grapas (110), caracterizado porque el poste (116) se divide en mitades (116a, 116b) para acomodar el paso de una hoja de cuchilla para cortar tejido y el material de refuerzo del cartucho (26) incluye un orificio correspondiente (120) formado en un extremo distal (122) del material de refuerzo del cartucho configurado para encajar sobre el poste (116).
  2. 2. El sistema de retención de refuerzo del cartucho (30) de acuerdo con la reivindicación 1, en donde el inserto que contiene grapas (110) está provisto de filas de cavidades para grapas (112) y un canal de cuchilla (114) que pasa longitudinalmente a través del inserto que contiene grapas (110) entre las filas de cavidades para grapas (112).
  3. 3. El sistema de retención de refuerzo del cartucho (30) de acuerdo con cualquiera de las reivindicaciones anteriores, en donde los dedos o proyecciones (124, 126) están colocados a ambos lados de un canal de cuchilla (114) para asegurar el material de refuerzo del cartucho (26) adyacentes a los bordes exteriores (130) y (132) del material de refuerzo del cartucho (26).
  4. 4. El sistema de retención de refuerzo del cartucho (30) de acuerdo con cualquiera de las reivindicaciones anteriores, en donde el extremo proximal (128) del inserto que contiene grapas (110) está provisto de múltiples conjuntos de dedos o proyecciones (140, 142, 144, 146) colocados a cada lado de un canal de cuchilla (114).
  5. 5. El sistema de retención de refuerzo del cartucho (30) de acuerdo con la reivindicación 4, en donde las proyecciones (140, 142, 144, 146) se acoplan a conjuntos correspondientes de ranuras (148, 150, 152, 154), respectivamente, para asegurar el extremo proximal (138) del material de refuerzo del cartucho (26) al extremo proximal (128) del inserto que contiene grapas (110).
  6. 6. El sistema de retención de refuerzo del cartucho (30) de acuerdo con la reivindicación 1, en donde el poste (116) es una protrusión dividida (156) que incluye mitades de tapa (158a, 158b) que definen pestañas (160a, 160b).
    7 El sistema de retención de refuerzo del cartucho (30) de acuerdo con la reivindicación 6, en donde un orificio (120) en un extremo distal (122) del material de refuerzo del cartucho (26) encaja sobre la protrusión dividida (156) para asegurar el extremo distal (122) del material de refuerzo del cartucho (26) al extremo distal (118) del inserto que contiene grapas (110).
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