ES2620372T3 - Sistemas de retención de material de refuerzo separable para uso con un dispositivo quirúrgico de grapado - Google Patents
Sistemas de retención de material de refuerzo separable para uso con un dispositivo quirúrgico de grapado Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/10—Surgical instruments, devices or methods, e.g. tourniquets for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
- A61B17/105—Wound clamp magazines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00477—Coupling
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00889—Material properties antimicrobial, disinfectant
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00893—Material properties pharmaceutically effective
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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
Abstract
Una grapadora quirúrgica (10) para desplegar grapas en un tejido, que comprende: una pareja de mordazas para acoplarse con el tejido, incluyendo la pareja de mordazas un cartucho de grapas (22) y un yunque (124), definiendo al menos una de las mordazas una pluralidad de cavidades (132), un material de refuerzo (24) de la hilera de grapas situado sobre una de las mordazas, y una pluralidad de retenedores (130) que pasan a través del material de refuerzo (24) de la hilera de grapas, estando dispuesto cada uno de los retenedores (130) en una de las cavidades (132) de modo que retengan de modo liberable el material de refuerzo (24) de la hilera de grapas sobre la al menos una mordaza, caracterizada por que el material de refuerzo (24) de la hilera de grapas incluye una pluralidad de ranuras (136) y las cavidades (132) están formadas como ranuras.
Description
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DESCRIPCION
Sistemas de retencion de material de refuerzo separable para uso con un dispositivo quirurgico de grapado Antecedentes
1. Campo de la invencion
La presente descripcion se refiere a sistemas de union de materiales de refuerzo para hileras de grapas. Mas concretamente, la presente descripcion se refiere a sistemas para unir temporalmente materiales de refuerzo para hileras de grapas a un yunque y a un cartucho de grapas de un instrumento quirurgico de grapado.
2. Antecedentes de la invencion
Los instrumentos quirurgicos de grapado, o "dispositivos de grapado", se emplean por los cirujanos para aplicar secuencial o simultaneamente una o mas filas de fijaciones, por ejemplo, grapas o fijaciones en dos partes, a un tejido corporal a los efectos de unir segmentos del tejido corporal entre sf. Tales dispositivos incluyen generalmente una pareja de mordazas o estructuras a modo de dedos entre las cuales se situa el tejido corporal que va a ser unido. Cuando el dispositivo de grapado se acciona, o se "dispara", unas barras de disparo de movimiento longitudinal hacen contacto con miembros de accionamiento de grapas en una de las mordazas. Los miembros de accionamiento de grapas empujan las grapas quirurgicas a traves del tejido corporal y en un yunque en la mordaza opuesta lo que pliega las grapas cerrandolas. Si el tejido va a ser retirado o separado, se puede disponer una cuchilla de corte en las mordazas del dispositivo para cortar el tejido entre las hileras de grapas.
Al grapar tejidos relativamente delgados o fragiles, es importante sellar de modo efectivo la hilera de grapas frente a fugas de aire o fluido. Ademas, a menudo es necesario reforzar la hilera de grapas frente al tejido para impedir desgarros en el tejido o la extraccion de las grapas a traves del tejido. Un procedimiento para impedir desgarros o extracciones implica situar un material de refuerzo de tejido biocompatible, o material "de refuerzo", entre la grapa y el tejido subyacente. En este procedimiento, se situa una capa de material de refuerzo contra el tejido y el tejido se grapa de un modo convencional. En procedimientos mas recientes, el material de refuerzo se situa sobre el propio instrumento de grapado antes de grapar el tejido. Un ejemplo ejemplar de esto se divulga en la patente norteamericana n° 5.542.594 de McKean et al. En McKean et al. se desliza un tubo de material de refuerzo sobre la mordaza de la grapadora. La grapadora se acciona a continuacion para grapar el tejido objeto y asegurar el material de refuerzo entre el tejido y la hilera de grapas para reforzar el tejido y la hilera de grapas.
El documento US5.542.594 divulga un aparato quirurgico de grapado que tiene un tejido quirurgico biocompatible unido de modo liberable al mismo. El tejido se sostiene de modo liberable a superficies del aparato de grapado mediante clavijas lineales que se asientan en cavidades circulares en la superficie del cartucho de grapas o con pinzas que se extienden alrededor del cartucho de grapas.
Al situar el material de refuerzo sobre las mordazas de la grapadora quirurgica, es deseable retener de modo liberable el material de refuerzo contra las mordazas. Asf pues, es deseable proporcionar retenedores para retener de modo liberable el material de refuerzo contra las mordazas del instrumento quirurgico.
Sumario
La presente invencion se refiere a la reivindicacion 1.
Se divulga una grapadora quirurgica para desplegar grapas en tejido, la grapadora quirurgica tiene una pareja de mordazas para acoplarse con el tejido, incluyendo un cartucho de grapas y un yunque, en la que al menos una de las mordazas define una pluralidad de cavidades. Un material de refuerzo de la hilera de grapas se situa sobre una de las mordazas y una pluralidad de retenedores pasa a traves del material de refuerzo de la hilera de grapas. Cada uno de los retenedores esta dispuesto en una de las cavidades en las mordazas de modo que retiene de modo liberable el material de refuerzo de la hilera de grapas sobre la al menos una mordaza.
El material de refuerzo de la hilera de grapas incluye una pluralidad de ranuras y las cavidades estan formadas igualmente como ranuras. Los retenedores son grapas que pasan a traves de las ranuras en el material de refuerzo de la hilera de grapas y la mordaza. En un modo de realizacion, el retenedor es una pinza que tiene una placa y un labio en angulo que se extiende desde la placa, acoplandose el labio en angulo con el material de refuerzo de la hilera de grapas. La pinza tiene un borde en angulo a lo largo de un lado, siendo acoplable el borde en angulo con un arrastre de la grapadora quirurgica.
En un modo de realizacion adicional, la pinza es una viga en I que tiene una porcion central y vigas superior e inferior que se extienden desde extremos de la porcion central. Una cara inferior de la viga superior se acopla con el material de refuerzo de la hilera de grapas y extremos de la viga inferior se acoplan por friccion con superficies que definen las cavidades.
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En ciertos modos de realizacion, el retenedor es absorbible en el cuerpo de un paciente.
Se divulga asimismo un procedimiento ejemplar para aplicar un material de refuerzo de la hilera de grapas a una hilera de grapas quirurgicas. El procedimiento incluye proporcionar una grapadora quirurgica que tiene una pareja de mordazas que incluye un cartucho de grapas y un yunque, teniendo la grapadora quirurgica un material de refuerzo dispuesto de modo liberable sobre al menos una de las mordazas y una pluralidad de retenedores que pasan a traves del material de refuerzo de la hilera de grapas y al interior de cavidades formadas en la al menos una mordaza.
En el procedimiento divulgado, la grapadora quirurgica es accionada para conducir grapas contenidas en el cartucho de grapas a traves del material de refuerzo y el tejido capturado entre las mordazas y al interior del yunque de modo que grape el material de refuerzo al tejido. En un ejemplo del procedimiento, los retenedores son retenidos en la al menos una mordaza una vez que material de refuerzo ha sido grapado al tejido. En un modo de realizacion alternativo del procedimiento divulgado, los retenedores son retenidos en el material de refuerzo una vez que el material de refuerzo ha sido grapado al tejido.
En un modo de realizacion del procedimiento divulgado los retenedores son grapas inversas retenidas por friccion en las cavidades, mientras que en un modo de realizacion alternativo del procedimiento divulgado los retenedores son pinzas que pasan a traves del material de refuerzo. Una superficie de las pinzas se acopla con el material de refuerzo.
Descripcion de los dibujos
Diversos modos de realizacion de los sistemas actualmente divulgados para unir materiales de refuerzo de hileras de grapas a un instrumento quirurgico de grapado se divulgan aqrn con referencia a los dibujos, en los cuales:
la figura 1 es una vista en perspectiva de un instrumento quirurgico de grapado que incorpora modos de realizacion de sistemas de retencion para unir materiales de refuerzo de hileras de grapas a un yunque y a un cartucho de grapas;
la figura 2 es una vista en perspectiva ampliada del extremo distal del instrumento quirurgico de grapado de la figura 1;
la figura 3 es una vista en perspectiva, con piezas separadas, de un modo de realizacion de un sistema de retencion del yunque y el material de refuerzo;
la figura 4 es una vista en perspectiva, mostrada parcialmente en seccion, tomada a lo largo de la lmea 4-4 de la figura 2;
la figura 5 es una vista lateral, mostrada parcialmente en seccion, tomada a lo largo de la lmea 5-5 de la figura 3, que ilustra el montaje inicial de un sistema de retencion del refuerzo del yunque;
la figura 6 es una vista lateral, mostrada parcialmente en seccion, que ilustra el plegado parcial de una pinza de retencion del sistema de retencion del refuerzo del yunque;
la figura 7 es una vista en perspectiva, con piezas separadas, de un modo de realizacion de un sistema de retencion del cartucho de grapas y el material de refuerzo;
la figura 8 es una vista en perspectiva de un conjunto de cartucho de grapas que ilustra el sistema de retencion del refuerzo del cartucho de grapas parcialmente montado;
la figura 9 es una vista lateral, mostrada parcialmente en seccion, tomada a lo largo de la lmea 9-9 de la figura 8;
la figura 10 es una vista lateral, mostrada parcialmente en seccion, similar a la figura 9, que ilustra el plegado de una grapa inversa del sistema de retencion del refuerzo del cartucho de grapas;
la figura 11 es una vista en perspectiva del extremo distal del instrumento quirurgico de grapado de la figura 1, situado alrededor de una seccion de tejido;
la figura 12 es una vista en seccion transversal de la seccion de tejido situada entre el conjunto de yunque y el conjunto de cartucho del instrumento quirurgico de grapado de la figura 1;
la figura 13 es una vista en seccion transversal, similar a la figura 12, durante el accionamiento inicial del instrumento quirurgico de grapado de la figura 1;
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la figura 14 es una vista en seccion transversal, similar quirurgico de grapado para grapar la seccion de tejido;
la figura 15 es una vista en seccion transversal, similar a de la seccion de tejido grapado;
la figura 16 es una vista en perspectiva de la seccion de tejido grapado con materiales de refuerzo unidos;
la figura 17 es una vista en seccion transversal tomada a lo largo de la lmea 17-17 de la figura 16;
la figura 18 es una vista en perspectiva ampliada del extremo distal del instrumento quirurgico de grapado de la figura 1 que incorpora modos de realizacion alternativos de sistemas de retencion para unir materiales de refuerzo de hileras de grapas a un yunque y cartucho de grapas;
la figura 19 es una vista en perspectiva, con piezas separadas, de otro modo de realizacion de un sistema de retencion del yunque y material de refuerzo de acuerdo con la figura 18;
la figura 20 es una vista en perspectiva de una pinza de retencion del sistema de retencion del refuerzo del yunque de la figura 19;
la figura 21 es una vista en perspectiva, mostrada parcialmente en seccion, tomada a lo largo de la lmea 21-21 de la figura 18;
la figura 22 es una vista en perspectiva de una pinza de retencion alternativa para su uso en el sistema de retencion del refuerzo del yunque de la figura 18;
la figura 23 es una vista en perspectiva de una pinza de retencion alternativa adicional para su uso en el sistema de retencion del refuerzo del yunque de la figura 18;
la figura 24 es una vista en perspectiva, con piezas separadas, de otro modo de realizacion de un sistema de retencion del cartucho de grapas y material de refuerzo de acuerdo con la figura 18;
la figura 25 es una vista en perspectiva de una grapa que ilustra el sistema de retencion del refuerzo del cartucho de grapas de la figura 24 parcialmente montado;
la figura 26 es una vista lateral, mostrada parcialmente en seccion, que ilustra la insercion de una grapa inversa que esta siendo insertada en un alojamiento de grapas;
la figura 27 es una vista lateral, mostrada parcialmente en seccion, que ilustra la grapa inversa retenida por friccion en el alojamiento de grapas;
la figura 28 es una vista en perspectiva del extremo distal del instrumento quirurgico de grapado ilustrado en la figura 18 situado alrededor de una seccion de tejido,
la figura 29 es una vista en seccion transversal tomada a lo largo de la lmea 29-29 de la figura 28;
la figura 30 es una vista en seccion transversal, similar a la figura 29, durante el accionamiento inicial;
la figura 31 es una vista en seccion transversal, similar a la figura 30, durante el accionamiento para grapar la seccion de tejido;
la figura 32 es una vista en seccion transversal, similar a la figura 31, tras el accionamiento ilustrando la liberacion de la seccion de tejido grapado;
la figura 33 es una vista en perspectiva de la seccion de tejido grapado con el material de refuerzo unido;
la figura 34 es una vista lateral, mostrada parcialmente en seccion, tomada a lo largo de la lmea 34-34 de la figura
33;
la figura 35 es una vista en perspectiva ampliada del extremo distal del instrumento quirurgico de grapado de la figura 1 que incorpora modos de realizacion alternativos adicionales de sistemas de retencion para unir materiales de refuerzo de hileras de grapas a un yunque y cartucho de grapas;
la figura 36 es una vista en perspectiva, con piezas separadas, de un sistema de retencion del refuerzo del cartucho de grapas de acuerdo con la figura 35;
a la figura 13, durante la accionamiento del instrumento la figura 14, tras el accionamiento que ilustra la liberacion
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la figura 37 es una vista en perspectiva de una pinza de retencion de viga en I del sistema de retencion del refuerzo del cartucho de grapas de la figura 36;
la figura 38 es una vista lateral, mostrada parcialmente en seccion, de la pinza de retencion de viga en I retenida por friccion en el cartucho de grapas;
la figura 39 es una vista en seccion transversal de una seccion de tejido situada entre los conjuntos del yunque y cartucho de la figura 35;
la figura 40 es una vista en seccion transversal, similar a la figura 39, durante el accionamiento inicial;
la figura 41 es una vista en seccion transversal, similar a la figura 40, durante el accionamiento para grapar la seccion de tejido;
la figura 42 es una vista en seccion transversal, similar a la figura 41, tras el accionamiento que ilustra la liberacion de la seccion de tejido grapado;
la figura 43 es una vista en perspectiva de la seccion de tejido grapado; y
la figura 44 es una vista en seccion transversal de la seccion de tejido grapado tomada a lo largo de la lmea 44-44 de la figura 43.
Descripcion detallada de modos de realizacion
A continuacion se describiran en detalle modos de realizacion de los sistemas de retencion de material de refuerzo separable divulgados actualmente para su uso con instrumentos quirurgicos de grapado, en referencia a los dibujos en los cuales numeros similares designan elementos identicos o correspondientes en cada una de las diversas vistas. Como es habitual en el estado de la tecnica, el termino "proximal" se refiere a aquella pieza o componente mas proximo al usuario u operario, esto es, al cirujano o medico, mientras que el termino "distal" se refiere a aquella pieza o componente mas alejado del usuario.
En referencia a continuacion a la figura 1, se divulga un instrumento quirurgico de grapado lineal o grapadora quirurgica 10 usado para grapar tejido y aplicar capas de material de refuerzo entre las grapas y el tejido subyacente. Un ejemplo ejemplar de este tipo de instrumento quirurgico de grapado se divulga en la patente norteamericana n° 7.128.253. La grapadora quirurgica 10 incluye generalmente un mango 12 que tiene un miembro tubular alargado 14 que se extiende de modo distal desde el mango 12. Un conjunto de mordazas 16 esta montado en un extremo distal 18 del miembro tubular alargado 14. El conjunto de mordazas 16 incluye un yunque de remachado de grapas 20 y un cartucho conteniendo grapas o cartucho de grapas 22. El cartucho de grapas 22 puede estar fijado permanentemente al miembro tubular alargado 14 o puede ser separable y sustituible asf por un nuevo cartucho de grapas 22. El yunque de remachado de grapas 20 esta montado de modo movible sobre el extremo distal 18 del miembro tubular alargado 14 y es desplazable entre una posicion abierta, separada del cartucho de grapas 22, y una posicion cerrada, sustancialmente contigua al cartucho de grapas 22.
El yunque de remachado de grapas 20 esta dotado de una capa de material de refuerzo del yunque 24 y un cartucho 22 esta dotado de una capa de material de refuerzo del cartucho 26 del modo descrito en mas detalle a continuacion. Una pluralidad de retenedores del refuerzo del yunque en forma de pinzas se dispone para asegurar de modo liberable el material de refuerzo del yunque al yunque de remachado de grapas 20. Igualmente, una pluralidad de retenedores del refuerzo del cartucho en la forma de pinzas desmontables se dispone para asegurar de modo 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 estan dispuestos para reforzar y sellar hileras de grapas aplicadas al tejido mediante la grapadora quirurgica 10.
La grapadora quirurgica 10 incluye un gatillo 32 montado de modo movible en el mango 12. El accionamiento del gatillo 32 funciona inicialmente para mover el yunque 20 de la posicion abierta a la posicion cerrada con relacion al cartucho de grapas 22 y acciona subsecuentemente la grapadora quirurgica 10 para aplicar hileras de grapas al tejido. Con el fin de orientar adecuadamente el conjunto de mordazas 16 con relacion al tejido que va ser grapado, la grapadora quirurgica 10 esta dotada adicionalmente de un boton giratorio montado en el mango 12. El giro del boton giratorio 34 con relacion al mango 12 hace girar el miembro tubular alargado 14 y el conjunto de mordazas 16 con relacion al mango 12 de modo que el conjunto de mordazas 16 se orienta adecuadamente con relacion al tejido que va a ser grapado.
En referencia a la figura 2, se proporciona un arrastre 36 para desplazar el yunque 20 entre las posiciones abierta y cerrada con relacion al cartucho de grapas 22. El arrastre 36 se mueve entre una ranura longitudinal 38 formada en el yunque 20. Una cuchilla (no mostrada) esta asociada con el arrastre 32 para cortar tejido capturado entre el yunque 20 y el cartucho de grapas 22 a medida que el arrastre 36 pasa a traves de la ranura 38.
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El yunque 20, el material de refuerzo del yunque 24 y los retenedores del refuerzo del yunque se combinan para formar un sistema de union del refuerzo del yunque 40 que permite que el material de refuerzo del yunque 24 sea soportado y fijado de modo liberable sobre el yunque 20. De modo similar, el cartucho de grapas 22, el material de refuerzo del cartucho 26 y los retenedores del refuerzo del cartucho se combinan para formar un sistema de union del refuerzo del cartucho 42 que permite que el material de refuerzo del cartucho 26 sea soportado y fijado de modo liberable sobre el cartucho de grapas 22. El sistema de union del refuerzo del yunque 40 y el sistema de union del refuerzo del cartucho 42 estan configurados concretamente para permitir que los materiales de refuerzo respectivos sean situados sobre superficies enfrentadas hacia dentro del yunque 20 y del cartucho de grapas 22 con el fin de facilitar el paso de la grapadora quirurgica 10 al interior del cuerpo de un paciente sin el riesgo de rasgar o arrugar los materiales de refuerzo respectivos a medida que la grapadora quirurgica 10 es insertada y manipulada en el cuerpo de un paciente.
En 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 proximal 44 en angulo o inclinado, configurado para acoplarse con el arrastre 36 con el fin de empujar el yunque 20 la posicion cerrada. La ranura 38 se extiende de modo distal desde el borde inclinado 44 y termina en una ranura transversal 46 que esta configurada para atrapar el arrastre 36 tras el accionamiento completo de la grapadora quirurgica 10 para impedir cualquier accionamiento subsiguiente de la grapadora quirurgica 10. Con el fin de asegurar las grapas suministradas por el cartucho de grapas 22 alrededor de los tejidos y materiales de refuerzo, el yunque 20 esta dotado de filas de alojamientos de remachado de grapas 48 que se extienden longitudinalmente, situadas a cada lado de la ranura longitudinal 38. Aunque tan solo se ilustra una unica fila de alojamientos de remachado de grapas 48 a cada lado de la ranura 38, se contempla que se puedan proporcionar sobre el yunque 20 filas multiples y/o escalonadas de alojamientos de remachado de grapas 48.
En referencia todavfa a la figura 3, se describira a continuacion un sistema de union del refuerzo del yunque 40, que incluye el yunque 20, el material de refuerzo del yunque 24 y retenedores del refuerzo del yunque. El material de refuerzo del yunque 24, asf como el material de refuerzo del cartucho 26. El material de refuerzo para el cartucho de grapas 22 y/o el yunque 20 puede estar fabricado de cualquier material biocompatible natural o sintetico. El material del que se forma el material de refuerzo puede ser bioabsorbible o no bioabsorbible. Se debe entender por supuesto que cualquier combinacion de materiales naturales, sinteticos, bioabsorbibles y no bioabsorbibles puede ser utilizada para formar el material de refuerzo.
Algunos ejemplos no limitativos de materiales a partir de los cuales se puede fabricar el material de refuerzo incluyen, aunque no se limitan a, acido polilactico, acido poliglicolico, polihidroxibutirato, polifosfacina, poliesteres, glicoles de polietileno, oxidos de polietileno, poliacrilamidas, acrilato metflico polihidroxietilico, polivinilpirrolidona, alcoholes de polivinilo, acido poliacnlico, poliacetato, policaprolactona, polipropileno, poliesteres alifaticos, gliceroles, poliaminoacidos, copoli(eter-ester), oxalatos de polialquilo, poliamidas, poli(iminocarbonatos), oxalatos de polialquilo, polioxaesteres, poliortoesteres, polifosfacenos y copolfmeros, copolfmeros de bloque, homopolfmeros, mezclas y combinaciones de los mismos.
En modos de realizacion, se utilizan polfmeros biologicos naturales para formar el material de refuerzo. Polfmeros biologicos naturales adecuados incluyen, aunque sin limitarse a, colageno, gelatina, fibrina, fibrinogeno, elastina, queratina, albumina, hidroxietilcelulosa, celulosa, hidroxipropilcelulosa, carboxietilcelulosa, chitan, chitosan y combinaciones de los mismos. Ademas, los polfmeros biologicos naturales pueden ser combinados con cualquiera de los otros materiales de polfmero descritos aqrn 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 impedir el crecimiento hacia dentro de tejido a partir de los tejidos circundantes, actuando asf como una barrera de adhesion e impidiendo la formacion de tejido cicatricial indeseado. Asf pues, en modos de realizacion, el material de refuerzo posee propiedades antiadhesivas. Las tecnicas para formar capas no porosas a partir de tales materiales estan dentro del alcance de aquellos expertos en la tecnica e incluyen, por ejemplo, vaciado, moldeo y similares.
En modos de realizacion, el material de refuerzo es poroso y posee propiedades hemostaticas. Cuando el material de refuerzo es poroso, tiene aberturas o poros sobre al menos una porcion de una superficie del mismo. Materiales adecuados para formar la capa porosa incluyen, aunque sin limitarse a, espumas (por ejemplo, espumas de celula abierta o cerrada). En modos de realizacion, los poros pueden ser de tamano y numero suficiente para interconectarse a traves de la totalidad del espesor de la capa porosa. En otros modos de realizacion, los poros no se interconectan a traves de la totalidad del espesor de la capa porosa. Todavfa en otros modos de realizacion, los poros no se extienden a traves de la totalidad del espesor de la capa porosa, sino que estan presentes en una porcion de la superficie de la misma. En modos de realizacion, las aberturas o poros se situan en una porcion de la superficie de la capa porosa, teniendo otras porciones de la capa porosa una textura no porosa. Aquellos expertos en la tecnica que lean la presente descripcion imaginaran otros patrones de distribucion de poros y configuraciones de la capa porosa.
Cuando el material de refuerzo es poroso, los poros pueden ser formados utilizando cualquier procedimiento adecuado para formar una espuma o esponja incluyendo, aunque sin limitarse a, la liofilizacion o secado por
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congelacion de una composicion. Tecnicas adecuadas para fabricar espumas estan dentro del alcance de aquellos expertos en la tecnica. Los materiales de refuerzo porosos pueden tener al menos un espesor de 0,2 cm, en modos de realizacion de, aproximadamente, 0,3 a 1,5 cm de espesor. Los materiales del refuerzo porosos pueden tener una densidad no superior a, aproximadamente, 75 mg/cm2 y, en modos de realizacion por debajo de, aproximadamente, 20 mg/cm2. El tamano de los poros en los materiales de refuerzo porosos puede ser de, aproximadamente, 20 |im a, aproximadamente, 300 |im, en modos de realizacion de, aproximadamente, 100 |im a, aproximadamente 200 |im.
El material de refuerzo puede incluir asimismo un miembro de refuerzo. El miembro de refuerzo puede estar asociado con una capa porosa o no porosa, o puede ser situado entre una capa no porosa y una capa porosa del material de refuerzo. Alternativamente, el miembro de refuerzo puede estar situado completamente dentro de una o mas de las capas individuales (esto es, embebido en la capa porosa, en la capa no porosa, o en ambas) del material de refuerzo. Asimismo se preve que el miembro de refuerzo puede estar situado en la superficie de una de las capas que constituyen el material de refuerzo y, en modos de realizacion, puede estar situado en una superficie exterior del material de refuerzo.
Algunos ejemplos no limitativos adecuados de miembros de refuerzo incluyen tejidos, mallas, monofilamentos, multifilamentos trenzados, fibras troceadas (algunas veces denominados en la tecnica como fibras discontinuas) y combinaciones de los mismos. Cuando el miembro de refuerzo es una malla, esta puede ser preparada utilizando cualquier tecnica conocida por aquellos expertos en la tecnica, tal como tricotado, tejido, fabricacion de encaje, calados o similares. Cuando se utilizan monofilamentos o multifilamentos trenzados como el miembro de refuerzo, los monofilamentos o multifilamentos trenzados pueden ser orientados de cualquier modo deseado. Por ejemplo, los monofilamentos o multifilamentos trenzados pueden ser situados aleatoriamente relativamente entre sf en el material de refuerzo. Como otro ejemplo, los monofilamentos o multifilamentos trenzados pueden estar orientados en una direccion comun en el material de refuerzo. Cuando se utilizan fibras troceadas como el miembro de refuerzo, las fibras troceadas pueden estar orientadas de cualquier modo deseado. Por ejemplo, las fibras troceadas pueden estar orientadas aleatoriamente o pueden estar orientadas en una direccion comun. Las fibras troceadas pueden formar asf un material no tejido, tal como estera o fieltro. Las fibras troceadas pueden ser unidas entre sf (por ejemplo, mediante fusion termica) o pueden permanecer desunidas entre sf Las fibras troceadas pueden ser de cualquier longitud adecuada. Por ejemplo, los trozos pueden tener una longitud de 0,1 mm a 100 mm, en modos de realizacion, una longitud de 0,4 mm a 50 mm. En un modo de realizacion ilustrativo, el material de refuerzo tiene fibras troceadas orientadas aleatoriamente que no han sido fundidas entre sf previamente, embebidas en el material de refuerzo.
Se preve que el material de refuerzo puede estar formado de cualquier material bioabsorbible, no bioabsorbible, natural o sintetico descrito anteriormente aqrn y combinaciones de los mismos. Cuando se utilizan monofilamentos o multifilamentos trenzados como el miembro de refuerzo, cualquier material de sutura disponible comercialmente puede ser empleado ventajosamente como el miembro de refuerzo.
En modos de realizacion, al menos un agente bioactivo puede ser combinado con el material de refuerzo y/o con cualquiera de los componentes individuales (la capa porosa, la capa no porosa y/o el miembro de refuerzo) utilizados para construir el material de refuerzo. En estos modos de realizacion, el material de refuerzo puede servir asimismo como vefuculo para suministrar el agente bioactivo. El termino "agente bioactivo", como se utiliza aqrn, se utiliza en su sentido mas amplio e incluye cualquier sustancia o mezcla de sustancias que tenga un uso clmico. Consecuentemente, los agentes bioactivos pueden tener o no una actividad farmacologica por sf mismos, esto es, por ejemplo, un tinte o una fragancia. Alternativamente, un agente bioactivo podna ser cualquier agente que proporcione un efecto terapeutico o profilactico, un compuesto que afecte o participe en el crecimiento de tejido, crecimiento celular, diferenciacion celular, un compuesto antiadhesivo, un compuesto que pueda ser capaz de invocar una accion biologica tal como una respuesta inmune, o podna jugar cualquier otro papel en uno o mas procesos biologicos.
Ejemplos de clases de agentes bioactivos que pueden ser utilizados de acuerdo con la presente descripcion incluyen antiadhesivos, antimicrobianos, analgesicos, antipireticos, anestesicos, antiepilepticos, antihistammicos, antiinflamatorios, medicamentos cardiovasculares, agentes de diagnostico, simpaticomimeticos, colinomimeticos, antimuscannicos, antiespasmodicos, hormonas, factores de crecimiento, relajantes musculares, bloqueantes de neuronas adrenergicos, antineoplasicos, agentes inmunogenicos, inmunosupresores, medicamentos gastrointestinales, diureticos, esteroides, lfpidos, lipopolisacaridos, polisacaridos, y enzimas. Se pretende asimismo que se puedan utilizar combinaciones de agentes bioactivos.
Se pueden utilizar agentes antiadhesivos o antiadhesion para impedir la formacion de adhesiones entre el material de refuerzo y los tejidos circundantes opuestos al tejido objetivo. Algunos ejemplos de estos agentes incluyen, aunque sin limitarse a, polivinilpirrolidona, carboximetilcelulosa, acido hialuronico, oxido de polietileno, alcoholes de polivinilo y combinaciones de los mismos.
Agentes antimicrobianos adecuados que pueden ser incluidos como un agente bioactivo en el material de refuerzo de la presente descripcion incluyen el triclosan, conocido asimismo como 2,4,4'-tricloro-2'-hidroxidifenil eter, la
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clorhexidina y sus sales, incluyendo acetato de clorhexidina, gluconato de clorhexidina, clorhidrato de clorhexidina, y sulfato de clorhexidina, plata y sus sales, incluyendo 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, oxido de plata, palmitato de plata, protema de plata, y sulfadiazina de plata, polimixina, tetraciclina, aminoglucosidos tales como la tobramicina y gentamicina, rifampicina, bacitracina, neomicina, cloranfenicol, miconazol, quinolonas tales como el acido oxolmico, norfloxacina, acido nalid^xico, pefloxacina, enoxacina y ciprofloxacino, penicilinas tales como la oxacilina y la piperacilina, nonoxinol-9, acido fusfdico, cefalosporinas, y combinaciones de los mismos. Ademas, se puede incluir como un agente bioactivo en el recubrimiento bioactivo de la presente descripcion protemas y peptidos antimicrobianos tales como lactoferrina bovina y lactoferricina B.
Otros agentes bioactivos los que pueden ser incluidos como un agente bioactivo del material de refuerzo de acuerdo con la presente descripcion incluyen: anestesicos locales; agentes antifertilidad no esteroideos; agentes parasimpaticomimeticos; agentes psicoterapeuticos; tranquilizantes; descongestivos; hipnoticos sedativos; esteroides; sulfonamidas; agentes simpaticomimeticos; vacunas; vitaminas; antimalariales; agentes antimigranas; agentes antiparkison tales como la L-dopa; antiespasmodicos; agentes anticolinergicos (por ejemplo, oxibutinina); antitusfgenos; broncodilatadores; agentes cardiovasculares tales como vasodilatadores coronarios y nitroglicerina; alcaloides; analgesicos; narcoticos tales como codema, dihidrocodeinona, meperidina, morfina y similares; no narcoticos tales como salicilatos, aspirina, acetaminofeno, d-propoxifeno y similares; antagonistas de los receptores opiaceos, tales como la naltrexona y la naloxona; agentes anticancer; anticonvulsivos; antiemeticos; antihistammicos; agentes antiinflamatorios tales como agentes hormonales, hidrocortisona, prednisolona, prednisona, agentes no hormonales, alopurinol, indometacina, fenilbutazona y similares; prostaglandinas y medicamentos citotoxicos; estrogenos; antibacterianos; antibioticos; antihongos; antivirales; anticoagulantes; anticonvulsivos; antidepresivos; antihistammicos; y agentes inmunologicos.
Otros ejemplos de agentes bioactivos adecuados que pueden ser incluidos en la composicion del recubrimiento incluyen virus y celulas, peptidos, polipeptidos y protemas, analogos, muteinas, y fragmentos activos de los mismos, tales como inmunoglobulinas, anticuerpos, citoquinas (por ejemplo, linfoquinas, monoquinas y quimioquinas), factores de coagulacion, factores hemopoyeticos, interleuquinas (IL-2, IL-3, IL-4, IL-6), interferones (P-IFN, a-IFN y y- IFN), eritropoyetina, nucleasas, factores de necrosis tumorales, factores de estimulacion de colonias (por ejemplo, GCSF, GM-CSF, MCSF), insulina, agentes antitumorales y supresores de tumores, protemas sangumeas, gonadotropinas (por ejemplo, FSH, LH, CG, etc.), hormonas y analogos hormonales (por ejemplo, hormona del crecimiento), vacunas (por ejemplo, antfgenos tumorales, bacterianos y virales); somatostatinas; antfgenos; factores de coagulacion; factores de crecimiento (por ejemplo, factores de crecimiento nervioso, factores de crecimiento similares a la insulina); inhibidores de protemas, antagonistas de protemas, y agonistas de proteinas; acido nucleicos, tales como moleculas antisentido , ADN y ARN; oligonucleotidos; polinucleotidos; y ribozomas.
En referencia a continuacion a las figuras 3-6, y con referencia inicialmente a las figuras 3 y 5, se describiran ahora los detalles del sistema de retencion del refuerzo del yunque 40 ejemplar. Como se apunto anteriormente, el sistema de retencion del refuerzo del yunque 40 incluye una pinza o grapa inversa 28 para asegurar el material de refuerzo del yunque 24 al yunque 20. La grapa inversa 28 tiene un vano o arco 50 que tiene una pareja de patas 52 y 54 que se extiende desde el arco 50. Las patas 52 y 54 acaban en puntas afiladas 56 y 58, respectivamente, que se proporcionan para penetrar en el material de refuerzo del yunque 24 cuando el sistema de retencion del yunque 40 es ensamblado.
Como se apunto anteriormente, el yunque 20 esta dotado de filas de alojamientos de remachado de grapas 48. En este modo de realizacion, se perforan parejas de orificios 60 en el yunque 20 para permitir que las patas 50 y 54 de las grapas inversas 28 pasen a traves de los mismos. Las parejas de orificios 60 se situan alineadas con las filas de alojamientos de remachado de grapas 48 y ocupan el lugar de uno o mas conjuntos de alojamientos de remachado de grapas 48 en las filas, como se muestra. En un modo de realizacion espedfico, las parejas de orificios 60 se situan en las filas mas externas de los alojamientos de remachado de grapas 48 para asegurar el material de refuerzo del yunque 24 a lo largo de sus bordes exteriores.
En referencia a continuacion a las figuras 3-6, con el fin de ensamblar el sistema de retencion del refuerzo del yunque 40, las patas 52 y 54 de las grapas inversas 28 se insertan a traves de parejas de orificios 60 en el yunque 20 de tal modo que las puntas 56 y 58 penetran en el material de refuerzo del yunque 24 (figura 5). Alternativamente, el material de refuerzo del yunque 24 puede estar dotado de orificios preformados para alojar las patas 52 y 54. Una vez que las patas 52 y 54 han sido situadas a traves del yunque 20 y del material de refuerzo del yunque 24, las patas 52 y 54 se doblan o pliegan para formar patas 62 y 64 dobladas hacia dentro (vease la figura 6) que aseguran el material de refuerzo del yunque 24 contra el yunque 20. Como se muestra, el arco 50 de la grapa inversa 28 es contiguo a una cara superior 66 del yunque 20 mientras que el material de refuerzo del yunque 24 se asegura contra una cara inferior 68 del yunque 20 mediante las patas 62 y 64 dobladas hacia dentro (figuras 4 y 6). La longitud de las patas 62 y 64 dobladas hacia dentro es lo suficientemente corta para que el material de refuerzo del yunque 24 pueda ser extrafdo del yunque 20 una vez que el material de refuerzo del yunque 24 ha sido grapado al tejido.
En referencia a continuacion a las figuras 7-10, se describiran ahora los detalles y el montaje del sistema de
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retencion del refuerzo del cartucho 42 ejemplar. En referencia inicialmente a la figura 7, y como se apunto anteriormente, el sistema de retencion del refuerzo del cartucho 42 incluye generalmente un cartucho de grapas 22, un material de refuerzo del cartucho 26 y pinzas separables o grapas inversas 30 que aseguran de modo liberable el material de refuerzo del cartucho 26 al cartucho de grapas 22. Las grapas inversas 30 son similares a las grapas, descritas a continuacion, utilizadas para grapar el tejido. Al contrario que las grapas inversas 28 asociadas con el sistema de retencion del refuerzo del yunque 40 descritas anteriormente, las grapas inversas 30 estan destinadas a separarse del cartucho de grapas 22 y desplazarse con el material de refuerzo del cartucho 26 cuando el material de refuerzo del cartucho 26 es grapado a un cuerpo. La grapas inversas 30 estan formadas de un material biocompatible y pueden estar formadas de un material absorbible o reabsorbible de modo que se deterioren en el cuerpo a lo largo del tiempo. Al contrario que las grapas inversas 28 asociadas con el sistema de retencion del refuerzo del yunque 40 descrito anteriormente, las grapas inversas 30 estan destinadas a separarse del cartucho de grapas 22 y desplazarse con el material de refuerzo del cartucho 26 cuando el material de refuerzo del cartucho 26 es grapado a un cuerpo.
El cartucho de grapas 22 incluye generalmente una porcion de cuerpo de plastico 70 y un canal externo 72. El cartucho de grapas 22 esta soportado sobre un miembro tubular alargado 14 mediante el canal externo 72. La porcion de cuerpo 70 incluye una pluralidad de filas de alojamientos de contencion de grapas 74 dispuestos para contener las grapas utilizadas para grapar el tejido, como se describe a continuacion. Un canal de cuchilla 78 esta situado entre filas de alojamientos de contencion de grapas 74 para el paso de una cuchilla utilizada para cortar el tejido grapado junto con el material de refuerzo del cartucho 26.
Las filas de alojamientos de contencion de grapas 74 incluyen alojamientos vados o falsos 78, separados longitudinalmente, para recibir las grapas inversas 30 con el fin de asegurar el material de refuerzo del cartucho 26 al cartucho de grapas 22.
Como se muestra en la figura 8, con el fin de ensamblar el sistema de retencion del refuerzo del cartucho 42, el material de refuerzo del cartucho 26 se situa sobre la porcion de cuerpo 70 de cartucho de grapas 22 y las grapas inversas 30 se insertan a traves del material de refuerzo del cartucho 26 y en el interior de los alojamientos falsos 78 (figura 9). Con referencia a las figuras 9 y 10, se proporciona una matriz de plegado 80 para asegurar por friccion las grapas inversas 30 en el alojamiento falso 78. Concretamente, la grapa inversa 30 incluye un arco 82 y una pareja de patas 84 y 86 que se proyectan desde el arco 82. Las patas 84 y 86 acaban en puntas o picos 88 y 90, respectivamente.
En referencia a las figuras 9 y 10, una vez que las patas 84 y 86 han sido insertadas a traves del material de refuerzo del cartucho 26 y en el interior del alojamiento falso 78, la matriz de plegado 80 es empujada hacia arriba en el alojamiento falso 78 de tal modo que los alojamientos de plegado 92 y 94 en la matriz de plegado 80 se acoplan con las puntas 88 y 90 y las doblan o pliegan para formar los extremos plegados 96 y 98 (figura 10). Cuando la grapa inversa 30 ha sido plegada en el alojamiento falso 78, las patas 84 y 86 se fuerzan o expanden hacia afuera de modo que se acoplan por friccion con las paredes 100 del alojamiento falso 78, reteniendo asf por friccion la grapa inversa 30 en el alojamiento falso 78.
En referencia a continuacion a las figuras 11 a 17, y con relacion inicialmente a las figuras 11 y 12, se describira ahora el uso de la grapadora quirurgica 10 para grapar y dividir una seccion tubular de tejido T. Inicialmente, el conjunto de mordazas 16, incluyendo el yunque 20 y el cartucho de grapas 22 se situa alrededor del tejido T que va a ser grapado. El arrastre 36 esta en una posicion proximal con relacion a la ranura del yunque 38. Como se muestra mejor en la figura 11, el inserto conteniendo grapas o porcion de cuerpo de plastico 70 incluye grapas 102 situadas en alojamientos individuales de grapas 104 de la fila de alojamientos de grapas 74. Las grapas 102 son de tipo convencional e incluyen un arco 106 que tiene una pareja de patas 108 y 110 que se extienden desde el arco 106. Las patas 108 y 110 acaba en puntas 112 y 114 que penetran en el tejido. Empujadores 116 se situan en los alojamientos de grapas 104 y estan situados entre las grapas 102 y la trayectoria de una barra de arrastre 118.
En referencia a continuacion a la figura 13, la grapadora quirurgica 10 es accionada inicialmente mediante el movimiento del gatillo 32 con relacion al mango 12 (figura 1) que provoca que el arrastre 36 se desplace en la direccion de la flecha B y contra el borde inclinado 44 del yunque 20, provocando asf que el yunque 20 se desplace a la posicion cerrada con relacion al cartucho de grapas 22. Como se muestra mejor en la figura 14, a medida que la barra de arrastre 118 avanza distalmente en la porcion de cuerpo de plastico 74, la barra de arrastre 118 empuja a los empujadores 116 hacia arriba contra los arcos 106 de las grapas 102, conduciendo las grapas 102 a traves del material de refuerzo del cartucho 26, el tejido T, el material de refuerzo del yunque 24 y hacia los alojamientos de remachado de grapas 48 en el yunque 20. Las puntas 112 y 114 que penetran en el tejido se curvan en los alojamientos de remachado de grapas 48 en el yunque 20 para asegurar asf el material de refuerzo del yunque 24 contra el tejido T mientras que el arco 106 asegura el material de refuerzo del cartucho 26 contra el tejido T.
Aunque no se muestra espedficamente, tras el accionamiento completo de la grapadora quirurgica 10, una cuchilla de corte asociada con la grapadora quirurgica 10 y transportada por el arrastre 36 corta el tejido T, asf como el material de refuerzo del yunque 24 y el material de refuerzo del cartucho 26 entre las filas de grapas 102 ya remachadas.
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Como se muestra en la figura 15, en un modo de realizacion, tras el movimiento del yunque 20 a la posicion abierta separada del cartucho de grapas 22, el material de refuerzo del yunque 24 se retira del yunque 20 y de los retenedores del refuerzo del yunque 28. Concretamente, el material de refuerzo del yunque 24 se suelta de las patas 62 y 64 dobladas hacia adentro de los retenedores del refuerzo del yunque 28, dejando los retenedores del refuerzo del yunque 28 unidos al yunque 20. Ademas, a medida que el yunque 20 se desplaza a la posicion abierta, el material de refuerzo del cartucho 26 se separa del cartucho de grapas 22. Como se apunto anteriormente, los retenedores del refuerzo del cartucho 30 estan retenidos por friccion en los alojamientos falsos 78. A medida que el material de refuerzo del cartucho 26 se separa del cartucho de grapas 22, los retenedores del refuerzo del cartucho 30 se sueltan de los alojamientos falsos 78 y permanecen con el tejido grapado T y el material de refuerzo del cartucho 26. Como se apunto anteriormente, los retenedores del refuerzo del cartucho 30 pueden estar formados de materiales absorbibles o reabsorbibles, que se degradan en el cuerpo lo largo del tiempo.
El tejido T resultante, dividido y cerrado con las grapas 102, se ilustra mejor en las figuras 16 y 17. Concretamente, el material de refuerzo del cartucho 26 esta asegurado contra el tejido T mediante los arcos 106 de las grapas 102 y el material de refuerzo del yunque 24 esta asegurado contra el tejido T por las puntas 112 y 114 que penetran en el tejido de las grapas 102, ya remachadas. De este modo, el material de refuerzo del yunque 24 y el material de refuerzo del cartucho 26 son grapados al tejido T, sellando y reforzando asf estas hileras de grapas creadas por las grapas 102.
En referencia a continuacion a las figuras 18-34, se divulgan modos de realizacion de un sistema de retencion del refuerzo del yunque 120 y de un sistema de retencion del refuerzo del cartucho 122 para su uso en el instrumento quirurgico de grapado 10. En referencia inicialmente a las figuras 18 y 19, se proporciona el sistema de retencion del refuerzo del yunque 120 para retener el material de refuerzo del yunque 24 contra un yunque 124 antes de graparlo al tejido. El yunque 124 es similar al yunque 20 descrito anteriormente e incluye un borde proximal inclinado 136 para acoplarse con un arrastre 36 con el fin de desplazar el yunque 124 entre posiciones abierta y cerrada con relacion al cartucho de grapas 22. El yunque 124 incluye ademas una ranura 128 para el paso de una cuchilla asociada con el instrumento quirurgico de grapado 10. El sistema de retencion del refuerzo del yunque 120 incluye una pluralidad de retenedores o pinzas 130 novedosos para ayudar a retener el material de refuerzo del yunque 24 sobre el yunque 124. El yunque 124 esta dotado de una serie de ranuras para pinzas 132, para recibir las pinzas 130, que estan separadas a lo largo de alojamientos de remachado de grapas 134 formados en el yunque 124. El material de refuerzo del yunque 24 contiene asimismo ranuras 136 del material de refuerzo para el paso de las grapas 130 a traves de las mismas.
En referencia por el momento a la figura 20, la pinza 130 esta formada generalmente como una placa 138 que tiene un borde inclinado 140 a lo largo de un primer extremo 142 de la placa 138 y un reborde o labio 144 que se proyecta aproximadamente en un angulo recto desde un segundo extremo 146 de la placa 138. El borde inclinado 140 esta configurado para ser acoplado por el arrastre 36 para forzar la salida de la pinza 130 del yunque 124 mientras que el labio 144 esta dispuesto para retener el material de refuerzo del yunque 24 contra el yunque 124 antes del grapado. Como se muestra mejor en las figuras 20 y 21, la pinza 130 esta retenida por friccion en una ranura de la pinza 132 del yunque 124 y una cara inferior 148 del labio 144 retiene el material de refuerzo del yunque 24 contra el yunque 124.
En un modo de realizacion alternativo mostrado en la figura 22, se puede proporcionar una pinza 150 alternativa con una pareja de labios separados 152 y 154 que se proyecta en un angulo generalmente recto desde una placa 156 de la pinza 150. Los labios 152 y 154 estan configurados para retener el material de refuerzo del yunque 24 contra el yunque 124 de un modo similar al de la pinza 130. La pinza 150 incluye asimismo un borde en angulo 158 para acoplarse con el arrastre 36 del instrumento quirurgico de grapado 10 para separar la pinza 150 y el material de refuerzo del yunque 24 del yunque 124.
Un modo de realizacion adicional de una pinza de retencion 160 se ilustra en la figura 23. La pinza 160 esta formada asimismo como una placa 162 que tiene un borde en angulo 164 para su acoplamiento con el arrastre 30 del instrumento quirurgico de grapado 10. La pinza 160 esta dotada de una pareja de labios 166 y 168 enfrentados que se extiende generalmente en angulo recto desde la placa 162 para aumentar la cantidad de superficie proporcionada para asegurar el material de refuerzo del yunque 24 al yunque 124.
En referencia a continuacion a las figuras 22-27, y con referencia inicialmente a la figura 24, el sistema de retencion del refuerzo del cartucho 122 es similar al sistema de retencion del refuerzo del cartucho 42 descrito anteriormente, incluyendo el cartucho de grapas 22 que tiene una porcion de cuerpo de plastico 70 y un canal externo 72 y el material de refuerzo del cartucho 26. Como se describio anteriormente, la porcion de cuerpo de plastico incluye filas de alojamientos de grapas 74 separadas por un canal de cuchilla 76. Sin embargo, en lugar de las grapas inversas 30, el sistema de retencion del refuerzo del cartucho 122 utiliza pinzas o grapas inversas 182 que no estan destinadas a ser plegadas en los alojamientos falsos 78 en la porcion de cuerpo de plastico 70. Antes bien, como se muestra mejor en las figuras 26 y 27, las patas 184 y 186 de la grapa inversa 182 se acoplan por friccion con las superficies internas 100 de los alojamientos falsos 78 mientras que un arco 188 de la grapa inversa 182 sostiene el material de refuerzo del cartucho 26 contra el cartucho de grapas 22.
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Con referencia a las figuras 28 y 29, en uso, el conjunto de mordazas 16 esta situado inicialmente alrededor de la seccion de tejido T con el yunque 124 la posicion abierta, separado del cartucho de grapas 22. El arrastre 36 esta en una posicion proximal con relacion al borde proximal inclinado 126 del yunque 24. Las pinzas 130 se situan a traves de ranuras 136 en el yunque 124 reteniendo el material de refuerzo del yunque 24 contra el yunque 124. Como se discutio anteriormente, la porcion de cuerpo de plastico 70 contiene grapas 102 situadas en los alojamientos de grapas 104. Las grapas inversas 182 estan situadas en alojamientos falsos 78 reteniendo el material de refuerzo de grapas 26 contra el cartucho de grapas 22.
En referencia a continuacion a la figura 30, tras accionar la grapadora quirurgica 10, el arrastre 36 se mueve distalmente en la direccion de la flecha B y contra el borde inclinado 126 del yunque 124, provocando que el yunque 124 se mueva a la posicion cerrada con relacion al cartucho de grapas 22 comprimiendo el tejido T entre ambos.
Como se observa mejor en la figura 31, a medida que el arrastre 36 continua moviendose distalmente lo largo del yunque 124, el arrastre 36 se acopla con el borde inclinado 140 de las pinzas 130 forzando las pinzas 130 hacia abajo dentro de las ranuras 132 en el yunque 124. Esto inicia la liberacion del material de refuerzo del yunque 24 del yunque 124. Al igual que se describio anteriormente, a medida que la barra de arrastre 118 avanza distalmente en respuesta al accionamiento de la grapadora quirurgica 10, la barra de arrastre 118 empuja a los empujadores 116 hacia arriba dentro de los alojamientos de grapas 104, conduciendo las puntas 112 y 114 de la grapa 102 que penetran en el tejido a traves del material de refuerzo del cartucho 26, el tejido T, el material de refuerzo del yunque 24 y en el interior de los alojamientos de remachado de grapas 134 en el yunque 124. Las puntas 112 y 114 se pliegan en los alojamientos de remachado de grapas 124, asegurando asf el material de refuerzo del yunque 24 al tejido T. Los arcos 106 se las grapas 102 aseguran el material de refuerzo del cartucho 26 al tejido T. Como se discutio anteriormente, una cuchilla asociada con la grapadora quirurgica 10 divide el tejido T, asf como el material de refuerzo del yunque 24 y el material de refuerzo del cartucho 26, entre las filas de grapas 102 ya remachadas.
En referencia por el momento a la figura 32, tras el movimiento del yunque 124 a la posicion abierta, el material de refuerzo del yunque tira de las pinzas 134 hacia fuera de las ranuras de pinzas 132 en el yunque 124 de tal modo que el material de refuerzo del yunque 24 se separa del yunque 124. Las grapas inversas 182 se sueltan de los alojamientos falsos 78 (figura 31), liberando el material de refuerzo del cartucho 26 del cartucho de grapas 22. Asf pues, tanto las grapas inversas 182 como las pinzas 130 permanecen con el tejido grapado T y, como se apunto anteriormente, estan formadas de un material degradable que se disolvera en el cuerpo a lo largo del tiempo.
Las secciones de tejido grapado T resultantes se ilustran mejor en las figuras 33 y 34. El material de refuerzo del cartucho 26 y el material de refuerzo del yunque 24 estan grapados al tejido T mediante las grapas 102, reforzando asf la hilera de grapas formada por las grapas 102 y sellando las grapas y los extremos cortados del tejido T.
En referencia a continuacion a las figuras 35-44, se divulga un modo de realizacion adicional alternativo de un sistema de retencion del refuerzo del cartucho 190 para su uso con la grapadora quirurgica 10 y el sistema de retencion del refuerzo del yunque 40 descrito anteriormente. El sistema de retencion del refuerzo del cartucho 190 incluye generalmente un cartucho de grapas 22 y un material de refuerzo del cartucho 26. Se proporciona una pluralidad de retenedores del refuerzo del cartucho o retenedores de viga en I 192 para acoplarse por friccion con el cartucho de grapas 22 y asegurar temporalmente el material de refuerzo del cartucho 26 al cartucho de grapas 22.
En referencia por el momento a la figura 37, el retenedor de viga en I incluye generalmente una porcion central rectangular 194 que tiene una viga superior rectangular 196 y una viga inferior 198 unida a la misma. Al igual que con los dispositivos de retencion descritos anteriormente, el retenedor 192 puede estar formado de un material que se degrada en el cuerpo a lo largo del tiempo. El material de refuerzo del cartucho 26 incluye una pluralidad de ranuras 200 que estan alineadas con los alojamientos falsos 78 en el cartucho de grapas 22 y permite el paso parcial del retenedor de viga en I 192 a traves de las mismas (figura 36).
Con referencia continuada a la figura 37 y asimismo a la figura 38, una superficie inferior 102 de la viga superior 196 del retenedor de viga en I 192 asegura material de refuerzo del cartucho 26 contra el cartucho de grapas 22. Extremos opuestos 204 y 206 de la viga inferior 198 del retenedor de viga en I 192 se acoplan por friccion con superficies internas 100 de los alojamientos falsos 78 para retener parcialmente por friccion el retenedor de viga en I 192 en el cartucho de grapas 22.
Con referencia a las figuras 39-42, el funcionamiento del sistema de retencion del refuerzo del cartucho 190 es similar al de los sistemas de retencion de refuerzo del cartucho 42 y 122 descritos anteriormente. Inicialmente, el conjunto de mordazas 16 esta situado alrededor del tejido T con el yunque 20 en la posicion abierta separado del cartucho de grapas 22. Tras accionar la grapadora quirurgica 10, el arrastre 36 avanza distalmente desplazando el yunque 20 a la posicion cerrada (figura 40). La barra de arrastre 118 avanza distalmente acoplandose con los empujadores 116 y conduciendo las grapas 102 a traves del material de refuerzo del cartucho 26, el tejido T, el material de refuerzo del yunque 24 y al interior de los alojamientos de remachado de grapas 48 para remachar las puntas 112 y 114 de las grapas 102 sobre el material de refuerzo del yunque 24 (figura 41). Tras el movimiento del yunque 20 a la posicion abierta, el material de refuerzo del yunque 24 se suelta de las grapas inversas 28. La viga
inferior 198 es lo suficientemente flexible para permitir que retenedor de viga en I 192 se suelte de los alojamientos falsos 78 y permanezca fijado al material de refuerzo del cartucho 26 (figura 42).
El tejido T resultante, dividido y cerrado con las grapas 102 se muestra en las figuras 43 y 44. Como se muestra, el 5 material de refuerzo del yunque 24 y el material de refuerzo del cartucho 26 estan grapados al tejido T, reforzando asf la hilera de grapas formada por las grapas 102 y sellando la seccion de tejido T. De este modo, el sistema de retencion del refuerzo del cartucho 190 permite que el material de refuerzo del cartucho 26 quede retenido de modo separable sobre el cartucho de grapas 22 y liberado una vez grapado al tejido.
Claims (8)
- 510152025303540REIVINDICACIONES1. Una grapadora quirurgica (10) para desplegar grapas en un tejido, que comprende:una pareja de mordazas para acoplarse con el tejido, incluyendo la pareja de mordazas un cartucho de grapas (22) y un yunque (124), definiendo al menos una de las mordazas una pluralidad de cavidades (132),un material de refuerzo (24) de la hilera de grapas situado sobre una de las mordazas, yuna pluralidad de retenedores (130) que pasan a traves del material de refuerzo (24) de la hilera de grapas, estando dispuesto cada uno de los retenedores (130) en una de las cavidades (132) de modo que retengan de modo liberable el material de refuerzo (24) de la hilera de grapas sobre la al menos una mordaza,caracterizada por que el material de refuerzo (24) de la hilera de grapas incluye una pluralidad de ranuras (136) y las cavidades (132) estan formadas como ranuras.
- 2. La grapadora quirurgica (10) de acuerdo con la reivindicacion 1, en la que el retenedor (130) es una pinza que pasa a traves de las ranuras (136) en el material de refuerzo (24) de la hilera de grapas y las ranuras (132) en la al menos una mordaza.
- 3. La grapadora quirurgica (10) de acuerdo con la reivindicacion 2, en la que el retenedor (130) es una pinza que tiene una placa (13) y un labio inclinado (144) que se extiende desde la placa (138), acoplandose el labio inclinado (144) con el material de refuerzo (24) de la hilera de grapas.
- 4. La grapadora quirurgica (10) de acuerdo con la reivindicacion 3, en la que la pinza (130) tiene un borde inclinado (140) a lo largo de un lado, pudiendose acoplar el borde inclinado (140) con un arrastre (36) de la grapadora quirurgica (10).
- 5. La grapadora quirurgica (10) de acuerdo con la reivindicacion 2, 3 o 4, en la que la pinza (130) es una viga en I (192) que tiene una porcion central (194) y unas vigas superior e inferior (196, 198) que se extienden desde la porcion central (194).
- 6. La grapadora quirurgica (10) de acuerdo con la reivindicacion 5, en la que un lado inferior de la viga superior (196) se acopla con el material de refuerzo (24) de la hilera de grapas.
- 7. La grapadora quirurgica (10) de acuerdo con la reivindicacion 5 o 6, en la que los extremos de la viga inferior (198) se acoplan por friccion con las superficies que definen las cavidades (132).
- 8. La grapadora quirurgica (10) de acuerdo con cualquiera de las reivindicaciones anteriores, en la que el retenedor (130) es absorbible en el cuerpo del paciente.
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| ES08252052T Active ES2393015T3 (es) | 2007-06-22 | 2008-06-13 | Sistema de retención de material de refuerzo separable para uso con un dispositivo quirúrgico de grapado |
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2007
- 2007-06-22 US US11/821,330 patent/US7845533B2/en active Active
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2008
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| US20080314960A1 (en) | 2008-12-25 |
| AU2008202670A1 (en) | 2009-01-22 |
| CN102319093A (zh) | 2012-01-18 |
| CA2634850A1 (en) | 2008-12-22 |
| EP2005895A3 (en) | 2010-04-21 |
| US20110036895A1 (en) | 2011-02-17 |
| US9198663B1 (en) | 2015-12-01 |
| JP2013150817A (ja) | 2013-08-08 |
| CN101336835B (zh) | 2011-09-21 |
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| EP2005895A2 (en) | 2008-12-24 |
| CN101336835A (zh) | 2009-01-07 |
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| JP5335299B2 (ja) | 2013-11-06 |
| US20140027490A1 (en) | 2014-01-30 |
| EP2417918A1 (en) | 2012-02-15 |
| JP5757669B2 (ja) | 2015-07-29 |
| EP2005895B1 (en) | 2012-08-08 |
| EP2417918B1 (en) | 2016-12-21 |
| CN102319093B (zh) | 2014-01-15 |
| US20150327865A1 (en) | 2015-11-19 |
| US7845533B2 (en) | 2010-12-07 |
| AU2008202670B2 (en) | 2013-08-29 |
| ES2694952T3 (es) | 2018-12-28 |
| EP3162303A1 (en) | 2017-05-03 |
| US8512402B2 (en) | 2013-08-20 |
| US9113873B2 (en) | 2015-08-25 |
| JP2009000531A (ja) | 2009-01-08 |
| CA2634850C (en) | 2016-01-05 |
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