ES2501466T3 - Sistema de retención de material de apoyo de grapas quirúrgicas - Google Patents

Sistema de retención de material de apoyo de grapas quirúrgicas Download PDF

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ES2501466T3
ES2501466T3 ES08251989.3T ES08251989T ES2501466T3 ES 2501466 T3 ES2501466 T3 ES 2501466T3 ES 08251989 T ES08251989 T ES 08251989T ES 2501466 T3 ES2501466 T3 ES 2501466T3
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Megan L. Prommersberger
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    • A61B17/10—Surgical instruments, devices or methods for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
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    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • 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
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    • 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
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • 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
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    • 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
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Abstract

Una grapadora quirúrgica (10) que comprende: un par de mandíbulas (16) que incluyen un cartucho (22) de grapas y un yunque (20), al menos una de las mandíbulas (16) incluye al menos dos salientes que se extienden longitudinalmente en una dirección proximal (50, 52), situados en un extremo distal de la al menos una mandíbula (16) y un poste (76) en el extremo proximal (78) de la al menos una mandíbula (16); y un material (24) de apoyo de la línea de grapas que incluye unos entrantes para recibir el enclavamiento de los al menos dos salientes (50, 52) y el poste (76), de modo que sea fijado de forma liberable a la al menos una mandíbula (16).

Description

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DESCRIPCIÓN
Sistema de retención de material de apoyo de grapas quirúrgicas
Antecedentes
1. Campo técnico
La presente descripción se refiere a sistemas de sujeción de materiales de apoyo de una línea de grapas. Más particularmente, la presente descripción se refiere a sistemas de materiales de apoyo de una línea de grapas de unión temporal a un yunque y a un cartucho que contiene grapas de un instrumento de grapado quirúrgico.
2. Antecedentes de la técnica anterior
Los instrumentos de grapado quirúrgicos o “dispositivos de grapado” son empleados por los cirujanos para aplicar de forma secuencial o simultánea una o más filas de fijadores, por ejemplo grapas o fijadores de dos piezas, a un tejido corporal con el fin de unir segmentos de tejido corporal conjuntamente. Tales dispositivos generalmente incluyen un par de mandíbulas o estructuras similares a dedos entre las cuales se coloca el tejido corporal que va a unirse. Cuando se acciona el dispositivo de grapado, o se “dispara”, unas barras de disparo móviles hacen contacto con los miembros de impulsión de la grapa en una de las mandíbulas. Los miembros de impulsión de las grapas empujan las grapas quirúrgicas a través del tejido corporal y a un yunque en la mandíbula opuesta, el cual dobla las grapas estrechamente. Si el tejido ha de ser retirado o separado se puede disponer una hoja de cuchilla en las mandíbulas del dispositivo para cortar el tejido entre las líneas de grapas.
Cuando se grapan tejidos relativamente delgados o frágiles es importante sellar de forma efectiva la línea de grapas para que no haya fugas de aire o de fluidos. Adicionalmente, a menudo es necesario reforzar la línea de grapas contra el tejido para impedir el rasgado del tejido o tirar de las grapas a través del tejido. Un método para impedir rasgaduras o tirones implica la colocación de un material biocompatible de tejido de refuerzo, o material “de apoyo”, entre la grapa y el tejido subyacente. En este método se coloca una capa de material de apoyo contra el tejido y el tejido es grapado de una forma convencional. En los métodos más recientes el material de apoyo se coloca en el instrumento de grapado propiamente dicho antes de grapar el tejido. Un método como ejemplo de esto se describe en la Patente de EEUU Nº 5.542.594 de McKean y otros, un tubo de material de apoyo es deslizado sobre la mandíbula de la grapadora. A continuación la grapadora es accionada para grapar el tejido objeto y para asegurar el material de apoyo entre el tejido y la línea de grapas para reforzar el tejido y la línea de grapas.
Algunas grapadoras quirúrgicas nuevas utilizan unos fijadores o pinzas para conectar temporalmente el material de apoyo con las mandíbulas de las grapadoras. No obstante, en algunos casos, sería conveniente moldear o mecanizar una estructura en las mandíbulas propiamente dichas para facilitar la sujeción de los materiales de apoyo correspondientemente estructurados. También sería conveniente proporcionar tal estructura de una forma que no interfiriera en la operación de una hoja de cuchilla con las mandíbulas.
Compendio
Se ha descrito una grapadora quirúrgica que tiene un par de mandíbulas que incluyen un cartucho de grapas y un yunque. Al menos una de las mandíbulas incluye al menos dos salientes que se extienden longitudinalmente situados en un primer extremo de la primera mandíbula. La grapadora quirúrgica tiene también un material de apoyo de la línea de grapas fijado de forma liberable a la al menos una mandíbula y que incluye unos entrantes para recibir los al menos dos salientes. En una realización cada uno de los al menos dos salientes incluye una parte de cuello y una parte bulbosa. En una realización alternativa cada uno de los dos salientes es relativamente recto. La al menos una mandíbula incluye una ranura de la cuchilla, que se extiende longitudinalmente, en donde los al menos dos salientes están separados por la ranura de la cuchilla.
En una realización posterior la al menos una mandíbula incluye una ranura de la cuchilla, que se extiende longitudinalmente. La ranura de la cuchilla separa los al menos dos salientes.
En las realizaciones la al menos una mandíbula incluye un poste en un segundo extremo y el material de apoyo incluye un agujero para recibir el poste. El poste está partido para permitir el paso de una cuchilla entre las dos partes.
En una realización específica el poste forma un saliente en forma de hongo que tiene una tapa, y la tapa define un ala para la aplicación con una parte del material de apoyo.
En otra realización la al menos una mandíbula incluye un par de postes y el material de apoyo incluye un par de agujeros para recibir el par de postes. Cada poste del par de postes está situado contiguo a un borde exterior del material de apoyo. La al menos una mandíbula incluye también una ranura que se extiende longitudinalmente, de modo que los dos postes están separados por la ranura.
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Descripción de los dibujos
Diversas realizaciones actualmente descritas de los sistemas de retención del material de apoyo de enclavamiento
se describen aquí con referencia a los dibujos, en donde: la Figura 1 es una vista en perspectiva de un instrumento de grapado quirúrgico que incorpora unas realizaciones de sistemas de retención para la sujeción de los materiales de apoyo de la línea de grapas a un yunque y 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 las piezas separadas, de una realización de un yunque y un sistema de retención del material de apoyo;
la Figura 4 es una vista en perspectiva del sistema de retención del material de apoyo del yunque montado;
la Figura 5 es una vista desde arriba del extremo distal del sistema de retención del material de apoyo del yunque de la Figura 4; la Figura 6 es una vista de la sección recta realizada a lo largo de la línea 6-6 de la Figura 4; la Figura 7 es una vista en perspectiva, con las piezas separadas, del extremo proximal del sistema de retención del
apoyo del yunque de la Figura 4; la Figura 8 es una vista de la sección recta realizada a lo largo de la línea 8-8 de la Figura 7; la Figura 9 es una vista en perspectiva, con las piezas separadas, de una realización alternativa de un sistema de
retención del apoyo del yunque; la Figura 10 es una vista de la sección recta realizada a lo largo de la línea 10-10 de la Figura 9; la Figura 11 es una vista en perspectiva, con las piezas separadas, de un ejemplo de un cartucho que contiene
grapas y de un sistema de retención del material de apoyo; la Figura 12 es una vista en perspectiva del sistema de retención del apoyo del cartucho montado de la Figura 11; la Figura 13 es una vista desde arriba del extremo proximal del sistema de retención del apoyo del cartucho de la
Figura 12;
la Figura 14 es una vista desde arriba de un ejemplo de un extremo proximal del sistema de retención del apoyo del cartucho; la Figura 15 es una vista de la sección recta realizada a lo largo de la línea 15-15 de la Figura 12; la Figura 16 es una vista en perspectiva, con las piezas separadas, del extremo distal del sistema de retención del
apoyo del cartucho de la Figura 12; la Figura 17 es una vista de la sección recta realizada a lo largo de la línea 17-17 de la Figura 16; la Figura 18 es una vista en perspectiva, con las piezas separadas, de otro ejemplo de un extremo distal del sistema
de retención del apoyo del cartucho; la Figura 19 es una vista de la sección recta realizada a lo largo de la línea 19-19 de la Figura 18; la Figura 20 es una vista en perspectiva, con las piezas separadas, de un ejemplo alternativo adicional de un
extremo distal de un sistema de retención del apoyo del cartucho; la Figura 21 es una vista de la sección recta realizada 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
situado alrededor de una sección del tejido;
la Figura 23 es una vista lateral, mostrada parcialmente en sección, del extremo distal del instrumento de grapado quirúrgico situado alrededor de la sección del tejido; la Figura 24 es una vista lateral, mostrada parcialmente en sección, durante el accionamiento inicial del instrumento
de grapado quirúrgico de la Figura 1; la Figura 25 es una vista en perspectiva de una sección del tejido grapada y dividida; y
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la Figura 26 es una vista de la sección recta realizada a lo largo de la línea 26-26 de la Figura 25.
Descripción detallada de las realizaciones
Las realizaciones de los sistemas de retención del apoyo del enclavamiento actualmente descritas para uso con instrumentos de grapado quirúrgico se describirán a continuación en detalle con referencia a los dibujos, en los que números iguales designan elementos idénticos o correspondientes en cada una de las varias vistas. Como es común en la técnica, el término “proximal” se refiere a la pieza o componente más cercano al usuario u operador, es decir el cirujano o médico, en tanto que el término “distal” se refiere a la pieza o componente más alejado del usuario.
Con referencia a la Figura 1, se describe un instrumento de grapado quirúrgico lineal o grapadora quirúrgica 10 para uso en el grapado de tejido y la aplicación de capas de un material de apoyo entre las grapas y el tejido subyacente. Un ejemplo ejemplar de este tipo de instrumento de grapado quirúrgico se describe en la Patente de EEUU Nº
7.128.253. La grapadora quirúrgica 10 generalmente incluye una empuñadura 12 que tiene un miembro tubular 14 que se extiende distalmente desde la empuñadura 12. Un conjunto de mandíbula 16 está montado en un extremo distal 18 del miembro tubular alargado 14. El conjunto de mandíbula 16 incluye un yunque 20 de remachado de las grapas y un cartucho que contiene grapas o cartucho 22 de grapas. El cartucho 22 de grapas puede estar permanentemente fijado al miembro tubular alargado 14 o puede ser separable y por tanto sustituible por un nuevo cartucho 22 de grapas. El yunque 20 de remachado de las grapas está montado de forma móvil en el extremo distal 18 del miembro tubular alargado 14 y puede moverse entre una posición abierta separada del cartucho 22 de grapas hasta una posición cerrada sustancialmente contigua al cartucho 22 de grapas.
El yunque 20 de remachado de las grapas está provisto de una capa de un material 24 de apoyo del yunque y el cartucho 22 de grapas está provisto de una capa de un material 26 de apoyo del cartucho en las formas descritas en adelante con más detalle. Un sistema de retención 28 del apoyo del yunque está incorporado en el yunque 20 y el material 24 de apoyo del yunque, y está dispuesto para asegurar de forma liberable el material 24 de apoyo del yunque al yunque 20 de remachado de las grapas. Igualmente, un sistema de retención 30 del apoyo del cartucho está incorporado en el cartucho 22 de grapas y en el material 26 de apoyo del cartucho y está dispuesto para asegurar de forma liberable el material 26 de apoyo del cartucho al cartucho 22 de grapas. El material 24 de apoyo del yunque y el material 26 de apoyo del cartucho están dispuestos para reforzar y sellar las líneas de grapas aplicadas al tejido por la grapadora quirúrgica 10.
El sistema de retención 28 del apoyo del yunque y el sistema de retención 30 del cartucho están particularmente configurados para permitir que los respectivos materiales de apoyo estén situados en las superficies frontales hacia dentro del yunque 20 y al cartucho 22 de grapas con el fin de facilitar el paso de la grapadora quirúrgica 10 al interior del cuerpo de un paciente sin el riesgo de rasgar o arrugar los respectivos materiales de apoyo a medida que la grapadora quirúrgica 10 es insertada en y manipulada dentro del cuerpo de un paciente.
La grapadora quirúrgica 10 incluye además un disparador 32 montado de forma móvil en la empuñadura 12. El accionamiento del disparador 32 funciona inicialmente para mover el yunque 20 de la posición abierta a la posición cerrada con relación al cartucho 22 de grapas y a continuación accionar la grapadora quirúrgica 10 para aplicar líneas de grapas al tejido. Con el fin de orientar apropiadamente el conjunto 16 de la mandíbula con relación al tejido que se va a grapar, la grapadora quirúrgica 10 está adicionalmente provista de un pomo de rotación 34 montado en la empuñadura 12. La rotación del pomo de rotación 34 con relación a la empuñadura 12 hace rotar el miembro tubular alargado 14 y el conjunto 16 de la mandíbula con relación a la empuñadura 12 para orientar apropiadamente el conjunto 16 de la mandíbula con relación al tejido que va a ser grapado.
Con referencia a las Figuras 1 y 2, un impulsor 36 está dispuesto para mover el yunque 20 entre las posiciones abierta y cerrada con relación al cartucho 22 de grapas. El impulsor 36 se mueve entre una ranura longitudinal 38 formada en el yunque 20. Una hoja de cuchilla (no mostrada) está asociada con el impulsor 32 para cortar el tejido aprisionado entre el yunque 20 y el cartucho 22 de grapas a medida que el impulsor 36 pasa a través de la ranura
38.
Con referencia a la Figura 3, con el fin de mover el yunque 20 entre las posiciones abierta y cerrada, el yunque 20 incluye un borde 40 proximal, en ángulo o en pendiente configurado para ser aplicado por el impulsor 36 con el fin de fijar el yunque 20 en la posición cerrada. La ranura 38 se extiende distalmente desde el borde 40 en pendiente y termina en una ranura transversal 42 que está configurada para aprisionar el impulsor 36 tras el accionamiento completo de la grapadora quirúrgica 10 para impedir cualquier accionamiento posterior de la grapadora quirúrgica
10. Con el fin de asegurar las grapas proporcionadas por el cartucho 22 de grapas alrededor de los tejidos y los materiales de apoyo, el yunque 20 está provisto de unas filas que se extienden longitudinalmente de bolsas 44 de remachado de las grapas situadas a uno u otro lado de la ranura longitudinal 38.
Con referencia también a la Figura 3, a continuación se describirá el sistema de retención 28 del apoyo del yunque, incorporado en el yunque 20 y el material 24 de apoyo del yunque. El material 24 de apoyo del yunque, así como el material 26 de apoyo del cartucho. El material de apoyo del cartucho 22 de grapas y/o del yunque 20 pueden estar hechos de cualquier material biocompatible natural o sintético. El material del que está formado el material de apoyo puede ser bioabsorbible o no bioabsorbible. Por supuesto que se debería comprender que cualquier combinación de
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materiales naturales, sintéticos, bioabsorbibles y no bioabsorbibles podría ser usada para formar el material de apoyo.
Algunos ejemplos no limitativos de materiales de los que puede estar hecho el material de apoyo incluyen pero no están limitados al poli(ácido láctico), poli(ácido glicólico), poli(hidroxibutirato), poli(fosfacina), poliésteres, glicoles de polietileno, óxidos de polietileno, poliacrilamidas, polihidroxietilmetilacrilato, polivinilpirrolidona, alcholes polivinílicos, ácido poliacrílico, poliacetato, policaprolactona, polipropileno, poliésteres alifáticos, gliceroles, poli(aminoácidos), copoli(ésteres de éter), oxalatos de polialkileno, poliamidas, poli(iminocarbonatos), oxalatos de polialkileno, polioxaésteres, poliortoésteres, polifosfacenos y copolímeros, copolímeros en bloque, homopolímeros, mezclas y sus combinaciones.
En realizaciones los polímeros biológicos naturales se usan en la formación del material de apoyo. Los polímeros biológicos naturales apropiados incluyen, aunque no están limitados a, colágeno, gelatina, fibrina, fibrinógeno, elastina, keratina, albúmina, hidroxietilo celulosa, celulosa, hidroxipropilo celulosa, carboxietilo celulosa, quitano, quitosano, y sus combinaciones. Además, los polímeros biológicos naturales pueden ser combinados con cualquiera de los otros materiales poliméricos aquí descritos para producir el material de apoyo.
El material de apoyo puede ser poroso o no poroso, o combinaciones de capas porosas y no porosas. Cuando el material de apoyo no es poroso, el material de apoyo puede retardar o impedir la invasión de tejido procedente de los tejidos circundantes, lo que actúa como una barrera de adherencia y que impide la formación de un tejido de cicatriz no deseado. De este modo, el material de apoyo posee unas propiedades antiadherentes. Las técnicas para la formación de capas no porosas a partir de tales materiales están dentro de la competencia de los expertos en la técnica e incluyen, por ejemplo, la fundición, el moldeo y similares.
En realizaciones el material de apoyo es poroso y posee propiedades hemostáticas. Cuando el material de apoyo es poroso, tiene unas aberturas o poros en al menos una parte de su superficie. Los materiales apropiados para la formación de la capa porosa incluyen, pero no están limitados a, espumas (por ejemplo, espumas celulares abiertas
o cerradas). En realizaciones los poros pueden ser en un número y tamaño suficiente para interconectar a través de todo el espesor de la capa porosa. En otras realizaciones los poros no interconectan a través de todo el espesor de la capa porosa. También en otras realizaciones los poros no se extienden a través de todo el espesor de la capa porosa, sino que más bien están presentes en una parte de su superficie. En realizaciones las aberturas o poros están situados en una parte de la superficie de la capa porosa con otras partes de la capa porosa que tienen una textura no porosa. Los expertos en la técnica que lean la presente descripción preverán otros patrones y configuraciones de distribución de los poros para la capa porosa.
Cuando el material de apoyo es poroso los poros pueden ser formados mediante el uso de cualquier método apropiado para la formación de una esponja que incluye, pero no está limitado a, la liofilización o desecación por congelación de un compuesto. Las técnicas apropiadas para hacer espumas están dentro de la competencia de los expertos en la técnica. Los materiales de apoyo porosos pueden tener al menos 0,2 cm de espesor, en realizaciones desde aproximadamente 0,3 a aproximadamente 1,5 cm de espesor. Los materiales de apoyo porosos pueden tener una densidad de no más de aproximadamente 75 mg/cm2 y, en realizaciones, por debajo de aproximadamente 20 mg/cm2. El tamaño de los poros en los materiales de apoyo porosos pueden ser desde aproximadamente 20 μm hasta aproximadamente 300 μm, en realizaciones, desde aproximadamente 100 μm hasta aproximadamente 200 μm.
El material de apoyo puede también incluir un miembro de refuerzo. El miembro de refuerzo puede estar asociado con una capa porosa o no porosa o puede estar situado entre una capa no porosa y una capa porosa del material de apoyo. Alternativamente, el miembro de refuerzo puede estar situado totalmente dentro de una o más de cada una de las capas (es decir, incorporado dentro de la capa porosa, la capa no porosa, o ambas) del material de apoyo. También se ha previsto que el miembro de refuerzo pueda estar situado en la superficie de una de las capas que constituyen el material de apoyo y, en realizaciones, puede estar situado en una superficie exterior del material de apoyo.
Algunos ejemplos no limitativos apropiados de miembros de refuerzo incluyen telas, mallas, trenzas de monofilamentos o multifilamentos, fibras troceadas (a veces denominadas en la técnica como fibras cortadas) y sus combinaciones. Cuando el miembro de refuerzo es una malla, puede ser preparado mediante el uso de cualquier técnica conocida por los expertos en la técnica, tal como tejido de punto, tejido, encaje de lanzadera, encaje de bolillos, o similares. Cuando las trenzas de monofilamentos o multifilamentos se usan como el miembro de refuerzo, las trenzas de monofilamentos o multifilamentos pueden estar orientadas de cualquier manera que se desee. Por ejemplo, las trenzas de monofilamentos o multifilamentos pueden estar colocadas aleatoriamente una con respecto a otra dentro del material de apoyo. Como otro ejemplo, las trenzas de monofilamentos o multifilamentos estar orientadas en una dirección común dentro del material de apoyo. Cuando las fibras troceadas se usan como el miembro de refuerzo las fibras troceadas pueden estar orientadas de cualquier manera deseada. Por ejemplo, las fibras troceadas pueden estar orientadas aleatoriamente o pueden estar orientadas en una dirección común. Las fibras troceadas pueden de este modo formar un material no tejido tal como una estera o un fieltro. Las fibras troceadas pueden estar unidas conjuntamente (por ejemplo, mediante fusión por calor) o pueden estar sin sujeción entre sí. Las fibras troceadas pueden tener cualquier longitud apropiada. Por ejemplo, el troceo puede ser de 0,1 mm
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hasta 100 mm de longitud, en realizaciones 0,4 mm a 50 mm de longitud. En una realización ilustrativa el material de apoyo tiene unas fibras orientadas aleatoriamente que no han sido fundidas antes conjuntamente incorporadas dentro del material de apoyo.
Se ha previsto que el miembro de refuerzo pueda ser formado a partir de cualquier material bioabsorbible, no bioabsorbible, natural o sintético previamente descrito aquí y sus combinaciones. Cuando se usan trenzas de monofilamentos o multifilamentos como miembro de refuerzo, cualquier material de sutura comercialmente disponible puede ser empleado ventajosamente como miembro de refuerzo.
En realizaciones, al menos se puede combinar un agente bioactivo con el material de apoyo y/o con cualquiera de cada uno de los componentes (la capa porosa, la capa no porosa y/o el miembro de refuerzo) usados para construir el material de apoyo. En estas realizaciones el material de apoyo puede también servir como un vehículo para la entrega del agente bioactivo. El término “agente bioactivo”, como se ha usado aquí, se usa en su sentido más amplio e incluye cualquier sustancia o mezcla de sustancias que tenga uso clínico. Por consiguiente, los agentes bioactivos pueden o pueden no tener una actividad farmacológica por sí mismos, por ejemplo un tinte, o fragancia. Alternativamente un agente bioactivo podría ser cualquier agente que proporcionase un efecto terapéutico o profiláctico, un compuesto que afectase o que participase en el crecimiento del tejido, el crecimiento celular, la diferenciación celular, un compuesto antiadherente, un compuesto que pueda ser capaz de provocar una acción biológica tal como una respuesta inmune, o podría desempeñar cualquier otro cometido en uno o más procesos biológicos.
Ejemplos de clases de agentes bioactivos que pueden ser utilizados de acuerdo con la presente descripción incluyen los antiadherentes, antimicrobianos, analgésicos, antipiréticos, anestésicos, antiepiléticos, antihistaminas, antiinflamatorios, medicinas cardiovasculares, agentes de diagnóstico, simpatomiméticos, colinomiméticos, antimuscarínicos, antiespasmódicos, hormonas, factores de crecimiento, relajantes musculares, bloqueantes neuronales adrenérgicos, antineoplásticos, agentes inmunogénicos, inmunosupresores, medicamentos gastrointestinales, diuréticos, esteroides, lípidos, lipopolisacáridos, polisacáridos y enzimas. También se pretende que se puedan usar combinaciones de agentes bioactivos.
Los agentes antiadherentes o antiadherentes se pueden usar para impedir la formación de adherencias entre el material de apoyo y los tejidos circundantes opuestos al tejido objetivo. Algunos ejemplos de estos agentes incluyen, pero no están limitados a, poli(vinilo de pirrolidona), carboximetil celulosa, ácido hialurónico, óxido de polietileno, alcholes de polivinilo y sus combinaciones.
Agentes antimicrobianos apropiados que pueden ser incluidos como un agente bioactivo en el material de apoyo de la presente descripción incluyen triclosano, también conocido como 2,4,4’-tricloro-2’-hidroxidifenilo éter, clorhexidina y sus sales, que incluyen acetato de clorhexidina, gluconato de clorhexidina, hidroclorato de clorhexidina, y sulfato de clorhexidina, plata y sus sales, que incluyen acetato de plata, benzoato de plata, carbonato de plata, citrato de plata, iodato de plata, ioduro 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, aminoglicósidos tales como tobramicina y gentamicina, rifampicina, bacitracina, neomicina, cloranfenicol, miconazola, quinolonas tales como ácido oxolínico, norfloxacina, ácido nalidíxico, pefloxacina, enoxacina y ciprofloxacina, penicilinas tales como oxacilina y pipracilo, nonoxinol 9, ácido fusídico, cefalosporinas, y las cominaciones de ellos. Además, las proteínas y péptidos antimicrobianos tales como la lactoferrina bovina y la lactoferrina B pueden ser incluidos como agente bioactivo en el revestimiento bioactivo de la presente descripción.
Otros agentes bioactivos que pueden ser incluidos como un agente bioactivo en el material de apoyo de acuerdo con la presente descripción incluyen: anestésicos locales; agentes antifertilidad no esteroideos; agentes parasimpatomiméticos; agentes psicoterapéuticos; tranquilizantes; descongestivos; hipnóticos sedantes; esteroides; sulfonamidas; agentes simpatomiméticos; vacunas; vitaminas; antimaláricos; agentes antimigraña; agentes antiparkinson tales como L-dopa; antiespasmódicos; agentes anticolinérgicos (por ejemplo, oxibutinino); antitusivos; broncodilatadores; agentes cardiovasculares tales como los vasodilatadores coronarios y la nitroglicerina; alcaloides; analgésicos; narcóticos tales como la codeína, dihidrocodeína, mepiridina, morfina y similares; no narcóticos tales como los salicilatos, aspirina, acetaminofeno, d-propoxifeno y similares; antagonistas del receptor opiáceo, tales naltrexona y naloxona; agentes anticancerígenos; anticonvulsivos; antieméticos; antihistaminas; agentes antiinflamatorios tales como los agentes hormonales, hidrocortisona, prednisolona, prednisona, agentes no hormonales, alopurinol, indometacina, fenilbutazona y similares; prostaglandinas y medicamentos citotóxicos; estrógenos; antibacterianos; antibióticos; antihongos; antivirales; anticoagulantes; anticonvulsivos; antidepresivos; antihistaminas; y agentes inmunológicos.
Otros ejemplos de agentes bioactivos apropiados que pueden ser incluidos en la composición del revestimiento incluyen virus y células, péptidos, polipéptidos y proteínas, analógicos, muteínas, y los fragmentos activos de ellos, tales como inmunoglobulinas, anticuerpos, citocinas (por ejemplo, linfocinas, monocinas, quimiocinas), factores coagulantes de la sangre, factores hemopoiéticos, interleucinas (IL-2, IL-3, IL-4, IL-6), interferones (-IFN), -IFN y -IFN), eritropoietina, nucleasas, factor de necrosis tumoral, factores estimuladores del colon (por ejemplo, GCSF, GM-CSF, MCSF), insulina, agentes antitumorales y supresores tumorales, proteínas de la sangre, gonadotropinas (por ejemplo, FSH, LH, CG, etc), hormonas y análogos de las hormonas (por ejemplo, hormona del crecimiento), vacunas
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(por ejemplo, agentes tumorales, bacterianos y virales); somatostatina; antígenos; factores de coagulación de la sangre; factores del crecimiento (por ejemplo, el factor de crecimiento de los nervios, factor del crecimiento similar a la insulina); inhibidores de las proteínas, antagonistas de las proteínas, y agonistas de las proteínas; ácidos nucleicos, tales como las moléculas antisentido, ADN y ARN; oligonucleótidos; polinucleótidos; y ribozimas.
El sistema de retención 28 del soporte del yunque está dispuesto para asegurar de modo liberable el material 24 del soporte del yunque al yunque 20 antes de graparlo al tejido. El sistema de retención 28 del soporte del yunque incluye una zona 46 elevada distalmente formada en la superficie inferior 48 del yunque 20. Como se aprecia mejor en las Figuras 3 y 5, la zona 46 elevada distalmente incluye un par de dedos o salientes 50 y 52 que se extienden proximalmente, configurados para asegurar de forma liberable un extremo distal del material 24 de apoyo del yunque en el yunque 20. Como se ha utilizado aquí, el término “salientes” se refiere a las estructuras dispuestas en las mandíbulas del instrumento que se asemejan a dedos y están configuradas para aplicar el material de apoyo situado entre los dedos en un modo de ajuste por fricción. Los salientes 50 y 52 incluyen los respectivos cuellos 54, 56 y las partes bulbosas 58, 60 que se extienden proximalmente desde los cuellos 54 y 56. Los recortes 62 y 64 están dispuestos en un extremo distal 66 del material 24 de apoyo del yunque para aplicación con los salientes 50 y 52 del yunque 20. Los recortes 62 y 64 están configurados con los respectivos cuellos 68, 70 y las partes bulbosas 72 y 74 que corresponden a los cuellos 54, 56 y las partes bulbosas 58, 60 del yunque 20. Los salientes 50 y 52 junto con los recortes 62 y 64 forman pares de dedos de enclavamiento para mantener el material 24 de apoyo del yunque en el yunque 20.
El sistema 28 del sistema de apoyo del yunque incluye además un poste 76 formado en un extremo proximal 78 del yunque 20. El material 24 de apoyo del yunque está provisto de un agujero 80 en un extremo proximal 82 que está configurado para aplicar el poste 76 y mantener el material 24 de apoyo del yunque tirante a lo largo de la superficie inferior 48 del yunque 20.
Como se aprecia mejor en las Figuras 3-6, el poste 76 está partido en dos mitades 76a y 76b del poste que definen un canal 84 entre ellas. El canal 84 corresponde a la ranura 38 en el yunque 20 y favorece el movimiento del impulsor 36, así como la cuchilla asociada con el impulsor 36, a través de la ranura 38 para cerrar el yunque 20 y cortar el material 24 de apoyo del yunque por la mitad después de grapado.
Con referencia de nuevo por el momento a las Figuras 3 y 4, con el fin de montar el material 24 de apoyo del yunque en el yunque 20 mediante el uso del sistema 28 de retención del apoyo del yunque, los recortes 62 y 64 en el extremo distal 66 del material 24 de apoyo del yunque están situados sobre los salientes 50 y 52 en la zona 46 elevada distalmente del yunque 20. Después de esto, el material 24 de apoyo del yunque es estirado tirante proximalmente y el agujero 80 es situado sobre el poste 76 en el extremo proximal 78 del yunque 20 para asegurar el material 24 de apoyo del yunque contra la superficie inferior 48 del yunque 20.
Con referencia a las Figuras 7 y 8, en ellas se ha descrito una realización alternativa de un sistema de retención 86 para asegurar el extremo proximal 82 del material 24 de apoyo del yunque al yunque 20 de una 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 resalto 88 en forma de hongo que tiene una tapa 90 ampliada para la colocación a través del agujero 80 en el material 24 de apoyo del yunque. La tapa 90 define una superficie del lado inferior o ala 92 configurada para aplicar el material 24 de apoyo del yunque. Similar al poste 76 descrito aquí anteriormente, el resalto 88 está partido en las mitades 88a y 88b de un resalto que definen una ranura 94 entre ellas para el paso del impulsor 36 y de una hoja de cuchilla asociada. La tapa 90 ayuda a impedir la liberación prematura del extremo proximal 82 del material 24 de apoyo del yunque. En tanto que no se ha mostrado específicamente, el área alrededor del agujero 80 puede incluir un área perforada para facilitar la separación del material 24 de apoyo del yunque del resalto 88.
Con referencia a las Figuras 9 y 10, se ha ilustrado en ellas una realización alternativa adicional de un sistema de retención 94 para retener el extremo proximal 82 del material 24 de apoyo del yunque en el yunque 20. El yunque 20 está provisto de un par de postes 96 y 98 separados horizontalmente situados a uno u otro lado de la ranura 38. El extremo proximal 82 del material 24 de apoyo del yunque está provisto de un par de agujeros correspondientes 100 y 102 configurados para ser aplicados por los postes 96 y 98, respectivamente. Los postes 96 y 98 sitúan el área que asegura el material 24 de apoyo del yunque hacia fuera de la ranura 38 en el yunque 20. Esto ayuda a mantener los bordes exteriores 104 y 106 del material 24 de apoyo del yunque tirantes durante el uso de la grapadora quirúrgica 10.
Con referencia ahora a las Figuras 11 y 12, se describirá ahora el sistema de retención 30 del apoyo del cartucho. Como se ha observado antes, el sistema de retención 30 del apoyo del cartucho está dispuesto para retener el material 26 de apoyo del cartucho en el cartucho 22 de grapas antes del grapado del tejido. El cartucho 22 de grapas generalmente incluye un canal exterior 108 en forma de U que rodea un inserto 110 que contiene las grapas. El inserto 110 que contiene las grapas está provisto de unas filas de bolsas 112 de grapas cuya función se describe más adelante con más detalle. Un canal 114 de la cuchilla pasa longitudinalmente a través del inserto 110 que contiene las grapas entre las filas de las bolsas 12 de grapas.
Con referencia por el momento a las Figuras 11 y 15, el sistema de retención 30 del apoyo del cartucho incluye un poste 116 formado en un extremo distal 118 del inserto 110 que contiene las grapas. El poste 116 es similar al poste
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76 descrito antes y está partido en las mitades 116a y 116b para alojar el pasaje de una hoja de cuchilla para cortar el tejido y el material 26 de apoyo del cartucho. El material 26 de apoyo del cartucho incluye un agujero correspondiente 120 formado en un extremo distal 122 del material de apoyo del cartucho y configurado para ajustarse sobre el poste 116 en el inserto 110 que contiene las grapas.
Con referencia nuevamente a las Figuras 11 y 12, y teniendo en cuenta la Figura 13, el sistema de retención 30 del apoyo del cartucho incluye además un par de dedos o salientes 124 y 126 separados que se extienden distalmente y relativamente rectos formados en un extremo proximal 128 del inserto 110 que contiene las grapas. Los salientes 124 y 126 están situados a uno u otro lado del canal 114 de la cuchilla para asegurar el material 26 de apoyo del cartucho contiguo a los bordes exteriores 130 y 132 del material 26 de apoyo del cartucho. El material 26 de apoyo del cartucho está provisto de unas ranuras correspondientes 134 y 136 formadas en un extremo proximal 138 del material 26 de apoyo del cartucho. Las ranuras 134 y 136 están configuradas para aplicar los salientes 124 y 126 del inserto 110 que contiene las grapas en un ajuste por fricción para retener el extremo proximal 138 del material 26 de apoyo del cartucho en el extremo proximal 128 del inserto 110 que contiene las grapas.
Con objeto de montar el sistema de retención 30 del apoyo del cartucho, el agujero 120 en el material 26 de apoyo del cartucho es situado sobre el saliente 116 en el extremo distal 118 del inserto 110 que contiene las grapas. Después de esto, el extremo proximal 138 del material 26 de apoyo del cartucho es situado sobre el extremo proximal 128 del inserto 110 que contiene las grapas. Las ranuras 134 y 136 en el material 26 de soporte del yunque son empujadas sobre los salientes 124 y 126 en el inserto 110 que contiene las grapas para aplicar el material 26 de apoyo del cartucho con el inserto 110 que contiene las grapas en un modo de ajuste por fricción.
Con referencia por el momento a la Figura 14, en un ejemplo alternativo el extremo proximal 128 del inserto 110 que contiene las grapas está provisto de varios conjuntos de dedos o salientes 140, 142 y 144, 146 situados a uno u otro lado del canal 114 de la cuchilla. Los salientes 140, 142 y 144, 146 aplican los correspondientes conjuntos de ranuras 148, 150 y 152, 154 respectivamente para asegurar el extremo proximal 138 del material 26 de apoyo del cartucho en el extremo proximal 128 del inserto 110 que contiene las grapas. Mediante la disposición de varios conjuntos de dedos en la mandíbula y las correspondientes ranuras en el material de apoyo se aumenta el área superficial disponible para un contacto por fricción que proporciona una conexión más segura. En tanto que no se ha mostrado específicamente, más de dos conjuntos de dedos y ranuras pueden ser dispuestos según la naturaleza del material de apoyo del cartucho y de la cantidad del contacto de fricción requerido.
Con referencia ahora a las Figuras 16-21, e inicialmente con respecto a las Figuras 16 y 17 se describirán ahora unos métodos alternativos del aseguramiento liberable del material de soporte a una mandíbula de un instrumento quirúrgico. Un resalto partido 156, similar al resalto 88 descrito antes aquí, está formado en un extremo distal 118 del inserto 110 que contiene las grapas e incluye las mitades 158a y 158b de la tapa que definen las alas 160a y 160b. El agujero 120 en el extremo distal 122 del material 126 de soporte del cartucho se ajusta sobre el saliente partido 156 para asegurar el extremo distal 122 del material 26 de soporte del cartucho al extremo distal 118 del inserto 110 que contiene las grapas.
Con referencia a las Figuras 18 y 19, los extremos distales 118 y 120 del inserto 110 que contiene las grapas y el material 26 de soporte del cartucho pueden estar provistos de unos postes 162, 164 separados y de unos agujeros 166, 168 separados, respectivamente. Los postes 162, 164 y los agujeros 166, 168 funcionan sustancialmente de forma idéntica a los postes 96, 98 y los agujeros 100, 102 antes descritos para asegurar el extremo distal 122 del material 26 de soporte del cartucho al extremo distal 118 del inserto 110 que contiene las grapas.
Con respecto a las Figuras 20 y 21, un poste 170 macizo no partido está dispuesto en el extremo distal 118 del inserto 110 que contiene las grapas. El poste 170 está situado distalmente de un extremo distal 172 del canal 114 de la cuchilla. Un agujero 174 está dispuesto en el extremo distal 120 del material 26 de soporte del cartucho y una hendidura longitudinal 176 se forma a través del área que define el agujero 174. En uso, una cuchilla asociada con la grapadora quirúrgica 10 corta a través del material 26 de soporte del cartucho a lo largo de la longitud del canal 114 de la cuchilla. Después de que el material 26 de soporte del cartucho haya sido grapado al tejido y cortado casi completamente por la mitad, la hendidura longitudinal 176 permite que el material 26 de soporte del cartucho se separe por la mitad sin rasgaduras o roces.
Con referencia ahora a las Figuras 22 a 26, e inicialmente con respecto a las Figuras 22 y 23, ahora se describirá el uso de la grapadora quirúrgica 10 para grapar y dividir una sección T de tejido tubular. Inicialmente, el conjunto 16 de la mandíbula, que incluye el yunque 20 y el cartucho 22 que contiene las grapas, está situado alrededor del tejido T que va a ser grapado. El impulsor 36 está en una posición proximal con respecto a la ranura 38 del yunque. Como se aprecia mejor en la Figura 23, el inserto 110 que contiene las grapas incluye las grapas 178 situadas dentro de cada una de las bolsas 180 de grapas de la fila de bolsas 112 de grapas. Las grapas 178 son de un tipo convencional e incluyen un tirante trasero 182 que tiene un par de patillas 184 y 186 que se extienden desde el tirante trasero 182. Las patillas 184 y 186 terminan en unas puntas 188 y 190 que penetran en el tejido. Los empujadores 192 están colocados dentro de las bolsas 180 de las grapas y están situados entre las grapas 178 y el recorrido de una barra 194 de impulsión.
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Con referencia ahora a la Figura 24, la grapadora quirúrgica 10 es inicialmente accionada por el movimiento del disparador 32 relativo a la empuñadura 12 (Figura 1) que hace que el impulsor 36 se mueva en la dirección de la flecha B y contra el borde en pendiente 40 del yunque 20, lo que hace que sea movido hasta la posición cerrada con relación al cartucho 22 de las grapas. A medida que la barra de impulsión 194 avanza distalmente dentro del inserto 110 que contiene las grapas, la barra 194 de impulsión obliga a los empujadores 192 hacia arriba contra los tirantes traseros 182 de las grapas 178 que impulsan las grapas 178 a través del material 26 de apoyo del cartucho, el tejido T, el material 24 de apoyo del yunque y hacia las bolsas 44 de remache de grapas en el yunque 20. Las puntas 188 y 190 que penetran en el tejido son dobladas dentro de las bolsas 44 de remachado de las grapas en el yunque 20 para de este modo asegurar el material 24 de apoyo del yunque contra el tejido T en tanto que el tirante trasero 182 asegura el material 26 de apoyo del cartucho contra el tejido T.
En tanto que no se ha mostrado específicamente, tras el accionamiento total de la grapadora quirúrgica 10, una hoja de cuchilla asociada con la grapadora quirúrgica 10 y llevada por el impulsor 36 corta el tejido T, así como el material 24 de apoyo del yunque y el material 26 de apoyo del cartucho entre las filas de las grapas 102 ahora remachadas. Tras el movimiento del yunque 20 hasta la posición separada del cartucho 22 de las grapas, el material 24 de apoyo del yunque tira separando del cartucho 22 de las grapas y el material 26 de apoyo del cartucho tira separando del cartucho 22 de las grapas. Específicamente, el extremo distal 122 del material 26 de apoyo del cartucho es cortado a través por la cuchilla y es liberado del poste 116. El extremo proximal 138 del material 26 de apoyo del cartucho se suelta de los salientes longitudinales 124, 126 en el extremo proximal 128 del inserto 110 que contiene las grapas. Igualmente, el extremo distal 66 del material 24 de apoyo del yunque se suelta de los salientes 50, 52 que se extienden proximalmente y el extremo proximal 82 del material 24 de apoyo del yunque se suelta del poste 78.
El tejido resultante T, dividido y grapado estrechamente con las grapas 178, está mejor ilustrado en las Figuras 25 y
26. Específicamente, el material 26 de apoyo del cartucho es asegurado contra el tejido T por medio de los tirantes traseros 182 de las grapas 178 y el material 24 de apoyo del yunque es asegurado contra el tejido T por las puntas 188 y 190 ahora remachadas que penetran en el tejido de las grapas 178. De este modo, el material 24 de apoyo del yunque y el material 26 de apoyo del cartucho son grapados al tejido T, que de este modo sella y refuerza estas líneas de grapas creadas por las grapas 178.
Se entenderá que se pueden realizar diversas modificaciones en las realizaciones aquí descritas. Por ejemplo, los diversos números de los dedos o salientes de enclavamiento pueden ser dispuestos para aumentar el contacto de fricción entre una mandíbula y un material de apoyo asociado. Además, los materiales de apoyo descritos pueden estar provistos de diversas zonas perforadas para facilitar la liberación de los dedos o salientes y postes descritos. Por lo tanto, la anterior descripción no debería ser interpretada como limitativa, sino solamente como ejemplificaciones de unas realizaciones particulares. Los expertos en la técnica preverán otras modificaciones dentro del alcance de las reivindicaciones aquí anejas.

Claims (11)

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    REIVINDICACIONES
    1. Una grapadora quirúrgica (10) que comprende:
    un par de mandíbulas (16) que incluyen un cartucho (22) de grapas y un yunque (20), al menos una de las mandíbulas (16) incluye al menos dos salientes que se extienden longitudinalmente en una dirección proximal (50, 52), situados en un extremo distal de la al menos una mandíbula (16) y un poste (76) en el extremo proximal (78) de la al menos una mandíbula (16); y
    un material (24) de apoyo de la línea de grapas que incluye unos entrantes para recibir el enclavamiento de los al menos dos salientes (50, 52) y el poste (76), de modo que sea fijado de forma liberable a la al menos una mandíbula (16).
  2. 2.
    La grapadora quirúrgica (10) mencionada en la reivindicación 1, en donde cada uno de los al menos dos salientes (50, 52) incluye una parte de cuello (54, 56) y una parte bulbosa (58, 50).
  3. 3.
    La grapadora quirúrgica (10) mencionada en cualquier reivindicación anterior, en donde cada uno de los al menos dos salientes (50, 52) es relativamente recto.
  4. 4.
    La grapadora quirúrgica (10) mencionada en cualquier reivindicación anterior, en donde la al menos una mandíbula (16) incluye una ranura de la cuchilla que se extiende longitudinalmente, en donde la ranura de la cuchilla separa los al menos dos salientes (50, 52).
  5. 5.
    La grapadora quirúrgica (10) mencionada en cualquier reivindicación anterior, en donde el material (24) de apoyo incluye un agujero (80) para recibir el poste (76).
  6. 6.
    La grapadora quirúrgica (10) mencionada en la reivindicación 5, en donde el poste forma un saliente (88) en forma de hongo que tiene una tapa (90), en donde la tapa (90) define un ala (92) para aplicación con una parte del material (24) de apoyo.
  7. 7.
    La grapadora quirúrgica (10) mencionada en cualquier reivindicación anterior, en donde el poste (76) está partido.
  8. 8.
    La grapadora quirúrgica (10) mencionada en cualquier reivindicación anterior, en donde la al menos una mandíbula (16) incluye un par de postes (96, 98).
  9. 9.
    La grapadora quirúrgica (10) mencionada en la reivindicación 8, en donde el material (24) de apoyo incluye un par de agujeros (100, 102) para recibir el par de postes (96, 98).
  10. 10.
    La grapadora quirúrgica mencionada en la reivindicación 8, en donde cada poste del par de postes (96, 98) está situado contiguo a un borde exterior del material (24) de apoyo.
  11. 11.
    La grapadora quirúrgica (10) mencionada en las reivindicaciones 8, 9 ó 10, en donde la al menos una mandíbula (16) incluye una ranura (38) que se extiende longitudinalmente, en donde los dos postes (96, 98) están separados por la ranura (38).
    10
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