ES2376063T3 - Aparato para sellar y cortar tejido. - Google Patents

Aparato para sellar y cortar tejido. Download PDF

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ES2376063T3
ES2376063T3 ES05013895T ES05013895T ES2376063T3 ES 2376063 T3 ES2376063 T3 ES 2376063T3 ES 05013895 T ES05013895 T ES 05013895T ES 05013895 T ES05013895 T ES 05013895T ES 2376063 T3 ES2376063 T3 ES 2376063T3
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effector
tissue
complementary
chassis
electrodes
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Thomas Patrick Ryan
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Covidien AG
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1442—Probes having pivoting end effectors, e.g. forceps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601—Cutting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/0063—Sealing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00875—Resistance or impedance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1442—Probes having pivoting end effectors, e.g. forceps
    • A61B2018/145—Probes having pivoting end effectors, e.g. forceps wherein the effectors remain parallel during closing and opening

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Un instrumento quirúrgico bipolar que está adaptado para conectarse a una fuente de energía radioeléctrica de RF, que comprende: un chasis (15) que tiene un eje longitudinal (A) dispuesto a su través; una extensión (17) que se extiende desde el chasis teniendo un primer efector (22) fijado al mismo, en donde el primer efector incluye un primer electrodo (26); un tubo (19) dispuesto dentro del chasis, teniendo un segundo efector (21) fijado al mismo, e donde el segundo efector incluye un segundo electrodo (20) y el en donde el segundo efector es movible con respecto al chasis, y el primer efector mediante un activador mecánico (32) a lo largo del eje longitudinal para acoplar el tejido entre el primer y segundo electrodos; caracterizado porque: el primer y segundo electrodos definen unas superficies (33, 34) de contacto con los vasos complementarios curvilíneos, los cuales se acoplan entre si con el movimiento de los efectores terminales entre si, en donde al menos una de las superficies de contacto con los vasos complementarias tienen una ranura que define un borde afilado de corte del tejido, en donde las superficies de contacto con los vasos curvilíneas complementarias incluyen el borde de corte del tejido afilado configurado para sellar y cortar selectivamente el tejido entre el primer y segundo electrodos dependientes de la energía electroquirúrgica aplicada entre el primer y segundo electrodos; y un sensor (31) para medir la impedancia entre el primer y segundo electrodos.

Description

Aparato para sellar y cortar tejido
1.
Campo de la invención
Esta invención está relacionada con un aparato para cortar y sellar vasos sanguíneos o el tejido utilizando un dispositivo de desplazamiento líneas bipolares que comprende el tejido o los vasos y en donde se aplica energía de radiofrecuencia (RF) para sellar el tejido y cortar el mismo.
2.
Antecedentes de la exposición
Con el fin de sellar los vasos sanguíneos durante las operaciones de cirugía, para el propósito de la anulación de las funciones de los vasos sanguíneos o para detener el sangrado, puede aplicarse una energía de radiofrecuencia (RF) en la estructura de los vasos en lugar de utilizar presillas o grapas. Tradicionalmente, los forceps se utilizan para crear un único sellado para la aplicación con la energía bipolar de RF). Normalmente, los forceps que tienen una bisagra entre los dientes que presionan contra cada lado del vaso están amordazados alrededor del tejido y aplicándose entonces la energía. Se encuentran algunas veces problemas con esta técnica debido al doblado de los forceps o a la falta de paralelismo entre los dientes que afectan a la forma en que el tejido o los vasos se comprimen
o se sellan.
La patente de los EE.UU. numero 4985030 describe un instrumento de coagulación bipolar que incluye un cilindro exterior. El extremo distal del cilindro incorpora un manguito, que incorpora a su vez un miembro de mordaza, cuyas mitades están dispuestas en una relación separada entre si. Además de ello, el instrumento incluye un cilindro interno que tiene en su extremo distal un miembro de mordaza en ángulo oblicuo formado por dos mitades dispuestas en una relación separada entre si. El instrumento está adaptado para recibir unos forceps de corte separados para cortar el tejido coagulado.
La patente de los EE.UU. número 5585896 tiene un dispositivo percutáneo para sellar las aberturas en los vasos sanguíneos. Se inserta un balón en el vaso y después se infla para forzar la pared del vaso en un collar de fijación.
La patente de los EE.UU. número 5383897 tiene un dispositivo para el sellado de pinchazos en los vasos sanguíneos mediante la conformación de un lúmen interior del vaso y por la colocación de lengüetas en el vaso para el fin del sellado.
La patente de los EE.UU.: numero 5391183 tiene un dispositivo para el sellado de los pinchazos en los vasos, mediante la inserción de material hemostático dentro del punto del pinchado y alrededor del vaso, con el fin de poder cerrar el punto del pinchado.
La patente de los EE.UU. numero 5437292 tiene un dispositivo percutáneo para sellar los puntos arteriales o venosos de pinchazos, sean accidentales o intencionales, en donde se mezclan el fibrinógeno y la trombina para formar un gel alrededor del lugar del pinchado para proporcionar la oclusión.
La patente de los EE.UU. numero 5411520 tiene un dispositivo para el sellado percutáneo de los vasos sanguíneos que se desliza en un catéter y que entra en el vaso sanguíneo con un anclaje y un tapón de colágeno.
La patente de los EE.UU. número 5415657 tiene un dispositivo que aborda el pinchazo en el vaso sanguíneo, se acopla a la superficie exterior y que aplica energía para proporcionar hemostasia.
La patente de los EE.UU. numero 5429616 tiene un dispositivo para sellar pinchazos en los vasos mediante la aplicación de un fluido y comprimiendo después los bordes mientras que se produce el sellado.
La patente de los EE.UU. numero 5441517 tiene un sistema para el sellado de pinchazos en los vasos sanguíneos mediante la inserción mecánica de un tapón con un anclaje para sellar el pinchazo.
La patente de los EE.UU. numero 5425739 expone un stent colocado dentro del vaso para sellar el mismo o colocado de una forma tal que se realice la anastomosis de los bordes del vaso.
La patente de los EE.UU. numero 5354271 expone una vaina deslizante para el cierre de los puntos de pinchazos que tiene dos partes que se expanden radialmente hacia fuera y que pueden utilizar una forma de acordeón en un catéter.
La patente de los EE.UU. número 5342393 es un dispositivo que repara pinchazos en los vasos, mediante la fijación del tejido de ambos lados interior y exterior del vaso. Se utiliza el remachado para cerrar las secciones amordazadas y pudiendo aplicar calor para separar el remache del sistema de suministro. Este dispositivo aplica energía térmica pero solo para separar el remache del punto de cierre,
La patente de los EE.UU. numero 5176695 es un dispositivo de corte mecánico laparoscópico con una cuchilla de movimiento de vaivén lineal que corta el tejido que resida en su ranura. La invención bipolar presente no contiene una cuchilla afilada puesto que sella y corta con la utilización de la energía de RF.
La patente de los EE.UU. numero 3862630 es un dispositivo en donde se utiliza la energía ultrasónica para cerrar los vasos sanguíneos por la vibración mecánica y por el frotado friccional. Cualquier calentamiento del tejido es un producto mínimo y superficial de la vibración mecánica utilizada para sellar los vasos.
La patente de los EE.UU. numero 2011169 es un electrodo quirúrgico con mordazas terminales que son de forma de U y que se anidan unas dentro de otras. No están aisladas entre si y por tanto son monopolares. En la presente invención las mordazas están aisladas y son bipolares. Las mordazas de la patente ‘169 están montadas en un endoscopio. No encajan conjuntamente como en la presente invención y están diseñadas más para el fin de eliminar los trozos de los tejidos y para coagular los mismos al mismo tiempo.
Todos los anteriores dispositivos son distintos en la exposición presente por varias razones. Estos dispositivos están hechos para el cierre de pinchazos de heridas. Esto implica que un canal de flujo viable permanecerá dentro del lumen del vaso sanguíneo después de aplicar cada dispositivo. El dispositivo ahora expuesto permanece externo al vaso sanguíneo en donde no existiría normalmente antes o después del procedimiento. El presente dispositivo y método sellan el vaso sanguíneo, y por tanto no proporcionan un recorrido para la sangre tal como se expone en los dispositivos anteriores. En la mayor parte de los casos después del sellado con el dispositivo presente y el método, el vaso estará todavía intacto, aunque con un sellado a través del mismo. Además de ello, el mero amordazado por el dispositivo expuesto no sella el vaso sanguíneo. Es la aplicación de la energía de RF la que forma una mordaza autóloga provocando una fusión de la intima para proporcionar el sellado.
Por tanto, para solventar las dificultades de los dispositivos anteriores se muestra y se describe un instrumento de contacto con el paciente para retener y aplicar la energía electroquirúrgica. Durante la disección quirúrgica, se encuentran frecuentemente vasos sanguíneos que necesitan sellarse y por tanto anular su función. Para su realización de una forma segura y fiable de forma que el vaso se selle debidamente y que no tenga fugas, se requiere una herramienta y un método que pueda crear una presilla autóloga. El dispositivo y método se describen brevemente. Un tubo largo está conectado a un lado de una fuente de alimentación bipolar. El tubo se mueve longitudinalmente, es decir a lo largo de su eje para el encuentro y compresión del vaso con una pieza terminal. Las dos piezas que se encuentran en ambos lados del vaso podrían ser planas, curvadas, triangulares, en ángulo, con ranura, o bien con otras formas, en tanto que una se encada en la otra. Si las piezas terminales son de otra forma distinta a la de forma plana, esto incrementará el área superficial que atraviesa el vaso creando un sellado más largo en el vaso sin incrementar el diámetro de las piezas terminales. El impulso aplicado de la energía de RF puede cortar el tejido después del sellado. El dispositivo y método al probarse sobre unos vasos nuevos producirán una presión concentrada adecuada para probar una junta sólida.
Las ventajas del dispositivo y método actuales son el cierre axial paralelo de las piezas terminales para proporcionar un sellador bipolar compacto y prevenir el cortocircuito. Un transductor de fuerza en línea podría proporcionar información de realimentación en la fuerza aplicada utilizada durante la cirugía. El dispositivo es bipolar para asegurar una seguridad añadida por el confinamiento de la corriente de RF a través del tejido entre los electrodos bipolares en el extremo del dispositivo.
SUMARIO DE LA INVENCIÓN
La presente invención proporciona un instrumento quirúrgico bipolar según lo expuesto adelante en la reivindicación
1. Las reivindicaciones dependientes están dirigidas a las características opcionales y preferidas.
El sellador o cortador de tejidos bipolar axialmente alargado para la aplicación de la energía electroquirúrgica por parte de un cirujano en el tejido y fluidos corporales de un paciente tiene preferiblemente un asa para la retención y manipulación por el cirujano. El chasis soportado en el asa puede extenderse axialmente con respecto al asa y alejándose del cirujano. El chasis puede ser movible hacia/desde el asa a lo largo del chasis. El chasis puede tener un extremo del asa y un extremo distal. Podría incorporar un tubo alargado con respecto al chasis y teniendo un extremo para el cirujano y un extremo para el paciente dispuestos a lo largo de su eje en la realización preferida. Un efector sobre el extremo del paciente y más preferiblemente está en posición para primeramente hacer contacto con el tejido con el movimiento axial desde el asa por parte del cirujano. El efector es preferiblemente de un material para la conducción de la energía electroquirúrgica. Un miembro puede estar soportado por el extremo distal del chasis en la posición opuesta del extremo del paciente del tubo. Una parte del miembro en el extremo distal del mismo está situado preferiblemente en forma transversal con respecto al eje del tubo. La parte puede estar hecha por un material de conducción de la energía electroquirúrgica y para actuar como un efector de extremo opuesto.
Un prime electrodo electroquirúrgico bipolar puede estar conectado eléctricamente al efector del extremo del paciente. Un segundo electrodo electroquirúrgico bipolar podría estar conectado eléctricamente a la parte del efector del extremo opuesto. El segundo electrodo electroquirúrgico bipolar está eléctricamente aislado del primer electrodo electroquirúrgico bipolar. El generador electroquirúrgico puede estar acoplado eléctricamente al primer y segundo electrodos electroquirúrgicos. El generador electroquirúrgico puede estar dispuesto para selectivamente suministrar energía electroquirúrgica bipolar a través del primer y segundo electrodos electroquirúrgicos bipolares.
El activador mecánico está soportado preferiblemente en forma movible sobre el asa mediante el uso por parte del cirujano. El activador más preferiblemente se conecta al tubo para mover axialmente el extremo del paciente y su efector hacia o alejándose desde la parte opuesta del efector terminal. El tejido el fluido corporal entre los efectores terminales pueden sellarse o cortarse por la aplicación de una compresión axial y una energía electroquirúrgica bipolar entre el primer y segundo electrodos electroquirúrgicos.
El efector terminal y la parte o efecto terminal opuesto incluyen unas superficies de sellado o de corte complementarias de acoplo para el acoplamiento parcial durante el movimiento axial a lo largo del eje entre si. El efector terminal y/o la abertura pueden fijarse en forma eliminable al paciente y/o al miembro. Las superficies complementarias están acopladas parcialmente y en forma curvilínea para proporcionar una mayor área de contacto del tejido que lo harían las superficies planas. Las superficies complementarias de acoplo parcial podrían ser paralelas pero oblicuas con el eje para proporcionar un contacto alargado con el movimiento axial entre los efectores terminales y la abertura. Las superficies complementarias de acoplo parcial podrían ser sustancialmente planas. Las superficies complementarias de acoplo parcial podrían ser circulares. Las superficies complementarias de acoplo parcial podrían ser elípticas. Las superficies complementarias de acoplo parcial podrían ser también triangulares. Las superficies complementarias de acoplo parcial pueden incluir al menos una nervadura y ranura conjugadas. Las superficies complementarias de acoplo parcial podrían incluir una o más nervaduras y ranuras de acoplo.
Un método de utilización de un sellador o cortador de tejido axial se describe para la aplicación por parte de una energía electroquirúrgica bipolar en el tejido y en los fluidos corporales de un paciente que pueda sellarse o cortar. El método puede tener los pasos de retención y manipulación por parte de un cirujano de un asa. La extensión axial de un chasis y/o un tubo soportado en el asa podría constituir una etapa. El método puede tener la etapa de movimiento a lo largo del eje del chasis y/o el tubo con el asa. El soporte del tubo para el movimiento axial con respecto al chasis podría constituir una etapa del método. El transporte del tubo para el movimiento axial y a lo largo del chasis podría ser una etapa del método. La etapa del método puede incluir el posicionamiento de un efector en el extremo del paciente del tubo para el primer contacto con el tejido axialmente alejándose del asa por parte del cirujano. Utilizando un miembro soportado en un extremo distal del chasis en posición alejada desde el extremo del paciente del tubo podría constituir una etapa del método. El método puede tener la etapa de tener una parte localizada transversalmente con respecto al eje en el miembro.
El método de utilización puede ejecutarse con un primer electrodo electroquirúrgico bipolar acoplado al efecto terminal del extremo del paciente y un segundo electrodo electroquirúrgico bipolar acoplado a la pieza. El aislamiento eléctrico del segundo electrodo bipolar electroquirúrgico del primer electrodo electroquirúrgico bipolar es otra etapa preferida del método de utilización. El método puede tener la etapa de acoplar selectiva y eléctricamente un generador electroquirúrgico al primer y segundo electrodos electroquirúrgicos para suministrar energía de RF electroquirúrgica bipolar desde el generador electroquirúrgico al primer y segundo electrodos electroquirúrgicos. El método puede tener la etapa de un cirujano que utilice un activador mecánico el cual esté soportado en forma movible en el asa. Al moverse axialmente con el activador, el extremo del paciente y/o el efector terminal opuesto de forma que el fluido corporal intermedio pueda sellarse o cortarse entre la parte a través de la aplicación de la compresión y la energía electroquirúrgica bipolar entre el primer y segundo electrodos electroquirúrgicos, en donde todo lo cual podría constituir una etapa preferida.
El método puede tener las etapas de aplicación del efector provisto con las superficies complementarias de acoplo parcial de sellado o de corte, y el acoplo parcial de las superficies complementarias con el movimiento axial entre si a lo largo del eje. El método podría utilizar la etapa de disposición en forma eliminable de la parte y/o del efector en el miembro y el chasis respectivamente. El método tiene la etapa de utilizar las superficies complementarias parciales acoplables a lo largo de los recorridos curvilíneos con un área de contacto del tejido mayor que entre las superficies planas. El método tiene la etapa de utilizar el acoplo parcial de las superficies complementarias paralelas pero a lo largo de un plano oblicuo con el eje para proporcionar el contacto alargado con el movimiento axial entre el efector terminal y la abertura.
El método puede tener la etapa de utilizar las superficies planas complementarias de acoplo parcial que existen quizás a lo largo de los planos de las superficies planas. El método podría tener la etapa de utilizar las superficies circulares complementarias de acoplo parcial que podrían estar presentes a lo largo de los arcos de las superficies circulares. El método podría tener la etapa de utilizar las superficies elípticas complementarias de acoplo parcial que existen preferiblemente a lo largo de las curvas de las elipses. El método puede tener la etapa de utilizar las superficie triangulares complementarias de acoplo parcial a lo largo de los bordes de los triángulos. El método podría tener la etapa de utilizar las superficies complementarias de acoplo parcial por el acoplamiento al menos de una nervadura al menos conjugada con una ranura. El método puede tener la etapa de utilización parcial de las superficies complementarias de acoplo que pueden incluir una o más nervaduras y ranuras asociadas.
BREVE DESCRIPCIÓN DE LOS DIBUJOS
La figura 1 es una vista en perspectiva de un sellador o cortador de tejido bipolar alargado para su aplicación por parte de un cirujano de emergía electroquirúrgica en el tejido, en donde el sellador o el cortador se deslizan a lo largo de su eje con una porción deslizante concéntrica interna para axialmente desplazar conjuntamente los efectores terminales.
La figura 2 es una vista en sección transversal tal como se vería a lo largo de las líneas 2-2 en la figura 1.
La figura 3 es una vista lateral de un sellador o cortador de tejido bipolar tubular alargado reutilizable como en la figura 1, en donde uno de los distintos efectores tienen unas superficies complementarias de acoplo parcial.
La figura 4 es una vista lateral de un sellador o cortador de tejido bipolar tubular desechable, tal como en la figura 1 en donde uno de los distintos efectores tienen unas superficies complementarias de acoplo parcial.
La figura 5 es una vista superior ampliada de la parte y del efector terminal con unas superficies complementarias de acoplo parcial que se anidan con unas mordazas conjugadas en forma de V.
La figura 6 es una vista superior ampliada de la parte y del efector terminal con superficies complementarias de acoplo parcial que se anidan con unas mordazas de nervaduras y ranuras conjugadas.
La figura 7 es una vista superior ampliada de la parte del efector terminal con superficies complementarias de acoplo parcial que se anidan con unas secciones macho y hembra enrasadas, en donde ambas son mordazas conjugadas en forma de V.
La figura 8 es una vista superior ampliada de la parte y del efector terminal con superficies complementarias de acoplo parcial, que se anidan con secciones macho y hembra enrasadas, en donde ambas son mordazas conjugadas en forma de U.
La figura 9 es una vista superior ampliada de la parte y del efector terminal con superficies complementarias de acoplo parcial que se anidan con unas secciones macho escalonadas y secciones hembra hendidas conformadas para encajar como unas mordazas conjugadas.
La figura 10 es una vista superior ampliada de la parte y el efector terminal con superficies de acoplo complementarias parciales que se anidan con un par de nervaduras verticales un par conjugado de sangrías conjugadas.
La figura 11 es una vista superior ampliada de la parte de un efector terminal con superficies complementarias de acoplo marcial que se anidan con una única nervadura vertical y unas sangrías conjugadas como las mordazas.
La figura 12 es una vista superior ampliada de la parte y del efector terminal con superficies complementarias de acoplo parcial que se anidan con un par de nervaduras verticales y sangrías conjugadas en donde una nervadura está sobre el efector terminal y a través de su sangría compañera y la nervadura de la parte como las mordazas.
La figura 13 ilustra las mordazas conjugadas de la figura 5 con un vaso sanguíneo intermedio con antelación al sellado.
La figura 14 ilustra las mordazas conjugadas de la figura 5 con un vaso intermedio durante el sellado.
La figura 15 es una vista ampliada parcial del efector terminal y la parte de la figura 1 vista desde arriba con un vaso abierto amordazado en forma intermedia durante el proceso del sellado.
La figura 16 es una ilustración en perspectiva de un vaso sellado.
La figura 17 muestra el voltaje, corriente, impedancia, potencia y energía capturados durante el sellado de una arteria esplénica.
DESCRIPCIÓN DETALLADA DE LA INVENCIÓN
La figura 1 es una vista en perspectiva de un sellador de tejido bipolar alargado o cortador 10 por la aplicación para la aplicación por un cirujano de energía electroquirúrgica en un tejido. El asa 11, para la retención y manipulación por el cirujano, se encuentra en el extremo proximal 12 del sellador o cortador 10 de tejido bipolar alargado. El asa 11 tiene un primer y segundo agarres 13 y 14 respectivamente. El chasis 15, soportado sobre el asa 11 por conexión mecánica con el primer agarre manal 13, se extiende axialmente a lo largo del eje “A” con respecto al asa 11 y alejándose del cirujano a una distancia adecuada para alcanzar el lugar operativo del paciente. El chasis 15 está compuesto por al menos dos partes. La primera es un tubo exterior 16 que se extiende desde el asa 11 a lo largo del eje “A”. El tubo exterior 16 está fijado en el chasis 15. La segunda parte es un miembro o extensión del chasis 17 que se extiende desde un extremo del paciente 18 del tubo exterior 16, también a lo largo del eje “A”. El tubo 19 interior es movible hacia/desde el asa 11 en la realización preferida. El tubo interior 19 está guiado a lo largo del eje “A”. El tubo interior 19 se conecta al segundo agarre 14 del asa para el acceso del cirujano. El extremo distal 20 está en el tubo interior 19 y está enfrentado en el emplazamiento operativo. El sellador tubular alargado o el cortador 10 por tanto en parte se desliza a lo largo de su eje “A”, con el tubo interno 19 el cual es deslizante interno y concéntrico para traer axialmente los efectores 21 y 22. El tubo interno 19 está soportado telescópicamente en la realización preferida, sobre el chasis 15 para el movimiento axial relativo y a lo largo del mismo. El tubo interior 19 tiene con respecto al chasis 15, un extremo 23 del cirujano y el extremo distal 20 que están dispuestos a lo largo del eje “A”, tal como se muestra en las figuras 1 y 3. La figura 2 es una vista de los tubos internos y externo 19 y 16 en sección transversal tal como se vería a lo largo de las líneas 2-2 en la figura 1. Los tubos preferidos exterior e interior 16 y 19 son metálicos entre si y desde el usuario por el revestimiento 19’ tal como se observa en la figura 2.
El efector terminal 21 en el extremo distal 20 está en posición de contacto con el tejido con el movimiento axial mediante el asa 11 por la manipulación del cirujano del segundo agarre del asa 14. La figura 3 es un vista lateral de la estructura tubular aplanada reutilizable de la figura 1, en donde ambos efectores 21 y 22 se observan desde el lado. El efector 21 y 22 están hechos de materiales para conducir la energía electroquirúrgica tal como un metal, polimero conductor o cerámica. El efector terminal 22 tiene un miembro 24 soportado por la extensión del chasis 17 normal al mismo en la posición opuesta al extremo del paciente 20 del tubo interior 19. La parte 25 en el miembro 24 está localizada transversalmente con respecto al eje “A” en la figura 1. Los efectores terminales 21 y 22 están por tanto opuestos para su acoplamiento con el desplazamiento axial del tubo interior 19 y/o chasis 15. La figura 4 es una vista lateral de una estructura tubular alargada desechable de la figura 1 con uno de los distintos efectores 21 y 22 que se muestran desde el lado de la figura 3. Tal como se muestra en la figura 3 la extensión del chasis 17, el miembro 24 y la parte 25 están hechos para conducir la energía electroquirúrgica. Por supuesto, el aislamiento puede añadirse según sea preciso para dirigir la energía electroquirúrgica bipolar al espacio entre los efectores terminales 21 y 22.
El electrodo 26 electro quirúrgico bipolar para el contacto con el tejido del paciente o los fluidos corporales está acoplado eléctricamente al efecto 22 más allá del extremo del paciente 18. El segundo electrodo 27 electro quirúrgico bipolar está acoplado eléctricamente a los efectores 21 y 22 para el contacto con el tejido del paciente o los fluidos corporales. El segundo electrodo 27 electro quirúrgico bipolar está aislado eléctricamente del primer electrodo 26 electroquirúrgico bipolar pero en posición para el suministro de la energía electroquirúrgica bipolar a través del tejido situado en forma intermedia. El generador 28 electroquirúrgico, en la figura 3, está acoplado eléctricamente al primer y segundo electrodos electroquirúrgicos 26 y 27 a través de los terminales 29 y 30m respectivamente. El generador electroquirúrgico 28 puede estar dispuesto para el suministro selectivo de energía electroquirúrgica bipolar al primero y segundo electrodos electroquirúrgicos bipolares 26 y 27. La aplicación selectiva de la energía electroquirúrgica es en respuesta al control de los cirujanos y/o al sensor 31 en el generador electroquirúrgico 28. El sensor 31 puede medir la impedancia a través del tejido entre los electrodos 26 y 27.
El activador mecánico 32, en la figura 3, está soportado preferiblemente en forma movible sobre el asa 11 para su uso por el cirujano. El activador mecánico 32 conecta el tubo interior 19 para el movimiento axial que desplaza el efector terminal 21 hacia delante o alejándose del efector terminal 22 en la realización preferida. El tejido y el fluido corporal intermedio pueden sellarse o cortarse entre los efectores 21 y 22, a través de la aplicación combinada de la compresión y de la energía electroquirúrgica bipolar entre el primero y segundo electrodos electroquirúrgicos 26 y
27.
Los efectores terminales 21 y 22 incluyen el sellado y complementario o las superficies de corte 33 y 34 para el acoplo parcial con el movimiento axial entre si, a lo largo del eje “A”. La figura 13 ilustra los efectores terminales 21 y 22 no de acuerdo con la invención, o las mordazas conjugadas de la figura 5 no de acuerdo con la invención con un vaso intermedio con antelación al sellado. De forma similar, la figura 14 ilustra los efectores 21 y 22 o las mordazas conjugadas de la figura 5 con un vaso intermedio durante el sellado. Los efectores terminales 21 y 22 podrían fijarse en forma desmontable al miembro 24 y/o al tubo interno 19, respectivamente. La figura 15 es una vista ampliada parcial de los efectores terminales 21 y 22 de la figura 1, vistos desde el lado con un vaso abierto amordazado en forma intermedia durante el método o proceso de sellado. Las superficies 33 y 34 complementarias conjugadas parciales en la figura 8 son curvilíneas para proporcionar más superficie de contacto del tejido del mismo ancho. En la figura 8 los efectores terminales 21 y 22 tienen unas superficies 33 y 34 complementarias conjugadas, que se anidan y se configuran con una parte 49 macho y una parte 50 hembra en forma de U para las mordazas.. La figura 9 es una vista superior ampliada de los efectores 21 y 22 no de acuerdo con la invención que muestra las superficies de conjugación que se anidan con una parte macho 35 escalonada y una parte hembra 36 en forma para encajar como mordazas. La figura 10 es una vista superior ampliada de los efectores terminales 21 y 22 no de acuerdo con la invención mostrando las superficies de conjugación que se anidan con un par de nervaduras verticales 38 y un par complementario de sangrías 37 como las mordazas. La figura 11 es una vista superior ampliada de los efectores terminales 21 y 22 no de acuerdo con la invención que muestran las superficies de conjugación que se anidan con una única nervadura vertical 39 y una sangría complementaria 40 tal como las mordazas. La figura 12 es una vista superior ampliada de los efectores terminales 21 y 22 no de acuerdo con la invención, que muestran las superficie de conjugado que se anidan con un par de nervaduras opuestas verticales 41 y las sangrías 42 opuestas complementarias en donde existe una nervadura 41 en cada uno de los efectores opuestos 21 ó 22.
Cualquiera de las mordazas curvilíneas de acoplo complementario incluso las de forma en “S” o las mostrada en la figura 1 podrían disponerse para proporcionar más área superficial para el contacto de las superficies planas definidas por los cordones transversales. La figura 5 es una vista superior ampliada de los efectores 21 y 22 no de acuerdo con la invención, que muestran las superficies conjugadas 33 y 34 que se anidan con las mordazas complementarias en forma de V no de acuerdo con la invención de las mordazas 43 y 44. La figura 6 es una vista superior ampliada de los efectores 21 y 22 que muestran las superficies conjugadas 33 y 34 que se anidan con una nervadura 45 y un canal 46 como las mordazas complementarias no de acuerdo con la invención. La figura 7 es una vista superior ampliada de los efectores terminales 22 y 23 no de acuerdo con la invención que muestran las superficies conjugadas 33 y 34 que se anidan con una parte macho 47 y una parte 48 hembra en forma de V como las mordazas complementarias no de acuerdo con la invención. Las superficies 33 y 34 complementarias de acoplo parcial no de acuerdo con la invención podrían ser paralelas pero sesgadas con el eje “A” como en la figura 15, para proporcionar un contacto alargado con el movimiento axial entre el tubo interno 19 y el chasis 15, pero manteniendo la dimensión del portal laparoscópico con los efectores 21 y 22 que tienen que pasar hacia una dimensión transversal mínima. Las superficies complementarias 33 y 34 de acoplo parcial no de acuerdo con la invención podrían ser substancialmente planas como en las figuras 3 y 4. Las superficies 33 y 34 de acoplo parcial pueden ser secciones circulares tales como las que aparecen en las figuras 1 y 8. Las superficies 33 y 34 complementarias parciales podrían ser elípticas y por tanto similares a las figuras 1 y 8 en donde las curvaturas son una parte de una elipse en lugar de ser un círculo. Debido a la perspectiva mostrada en la figura 1, las diferencias que se observan en tal ilustración entre un círculo y una elipse no pueden percibirse. Las superficies 33 y 34 complementarias de acoplo parcial podrían también ser triangulares como en las figuras 5, 7, 13 y 14. Las superficies complementarias 33 y 34 de acoplo parcial pueden incluir al menos una nervadura conjugada y ranuras como en las figuras 6 y 11. Las superficies 33 y 34 complementarias de acoplo parcial podrían incluir varias nervaduras como en las figuras 10 y 12.
Un método de aplicar el sellador o cortador 10 bipolar tubular alargado a lo largo del eje “A” incluye el uso por un cirujano para suministrar energía electroquirúrgica bipolar al tejido y a los fluidos corporales de un paciente. El método tiene las etapas de fijación y manipulación del asa 11 por el cirujano. El tubo 19 interno que se extiende axialmente y/o el chasis 15 soportado en el asa 11 por el cirujano es una etapa. El método puede tener la etapa de mover el tubo interno 19 con respecto al chasis 15 a lo largo del eje “A”. El transporte del tubo 19 interno para el movimiento axial con respecto y a lo largo del chasis 15 es una etapa del método preferido. La etapa del método incluye el posicionamiento de un efector 22 sobre el extremo del paciente 18 para el primer contacto con el movimiento axial del tubo interno 19 por parte del cirujano. Utilizando un miembro soportado 24 el chasis 15 es una etapa del método. El método puede tener la etapa de utilizar una parte 25 localizada transversalmente con respecto al eje “A” y sobre el miembro 24.
El método de utilización tiene un primer electrodo 26 electroquirúrgico bipolar acoplado al efector 22, extendiéndose desde el extremo del paciente 18 y un segundo electrodo 27 electroquirúrgico bipolar 27 acoplados al efector terminal 21. El aislamiento eléctrico del segundo electrodo 27 electroquirúrgico bipolar desde el primer electrodo 26 electroquirúrgico bipolar es otra etapa preferida del método. El método preferiblemente tiene la etapa de acoplar selectivamente un generador 28 electroquirúrgico para el primer y segundo electrodos electroquirúrgicos para suministrar energía electroquirúrgica bipolar desde el generador electroquirúrgico al primer y segundo electrodos electroquirúrgicos bipolares. 26 y 27. El método tiene más preferiblemente la etapa de utilizar un activador mecánico 32 soportado en forma movible sobre el asa 11. Al moverse axialmente con el activador mecánico 32 el tubo interior 19 y el efecto 21 hacia o alejándose del efecto terminal 22, de forma que el tejido y el fluido corporal intermedio puedan sellarse o cortarse entre los efectores 21 y 22 la aplicación y la compresión de la energía electroquirúrgica bipolar entre el primero y segundo electrodos electroquirúrgicos 26 y 27, siendo ello una etapa preferida.
El método puede tener las etapas de aplicar los efectores terminales previstos con superficies 33 y 34 de sellado o cortado complementarias parcialmente, y un acoplo parcial de las superficies 33 y 34 de sellado o cortado, con el movimiento axial entre si a lo largo del eje “A”. La figura 16 es una ilustración en perspectiva de un vaso sellado 51 como una consecuencia de la ejecución del método para formar el sellado 52. El método podría utilizar la etapa de elegir la fijación desmontable de los efectores 26 y 27, el tubo interno 19 y el chasis 15, respectivamente. El método tiene la etapa de utilizar el acoplo parcial de las superficies complementarias 33 y 34 acoplables a lo largo de los recorridos curvilíneos para proporcionar más área de contacto del tejido que entre las superficies planas. El método tiene la etapa de utilizar un acoplo parcial de las superficies complementarias 33 y 34 que son preferiblemente paralelas a lo largo de un plano sesgado “A” para proporcionar un contacto alargado con el movimiento axial entre el tubo interno 19 y el chasis 15.
El método tiene la etapa de utilizar las superficies 33 y 34 planas complementarias de acoplo parcial que se disponen a lo largo de los planos de las superficies planas. El método tiene la etapa de utilizar las superficies 33 y 34 circulares complementarias de acoplo parcial que podrían estar a lo largo de los arcos de las superficies circulares. El método tiene la etapa de utilizar las superficies 33 y 34 elípticas complementarias de acoplo parcial, las cuales se disponen preferiblemente a lo largo de las curvas de las elipses. El método tiene la etapa de utilizar las superficies triangulares 33 y 34 complementarias de acoplo parcial, que pueden ser los bordes de los triángulos. El método tiene la etapa de utilizar las superficies 33 y 34 complementarias de acoplo parcial mediante el acoplo de una nervadura y una ranura conjugadas. El método tiene la etapa de utilizar las superficies 33 y 34 complementarias de acoplo parcial que incluyen una o más nervaduras.
Como resultado de las pruebas de laboratorio de un modelo del sellador o cortador de tejidos bipolar, los resultados han demostrado un rendimiento excelente en el sella de una amplia gama de vasos de distintos tamaños. El sellador o cortador de tejidos bipolar con un recorrido lineal fue probado sobre unas arterias esplénicas de porcino fresco de 1,8 a 3,3 mm. La simple activación de energía (14 W, 500 kHz) se utilizó en cada vaso firmemente amordazado entre los electrodos extremos bipolares del efector terminal. La figura 17 muestra el voltaje, la corriente, impedancia, potencia y energía durante la activación en una arteria selénica de porcino de 2,6 mm con el dispositivo bipolar mostrado en la figura 15. El voltaje abarca desde 18-23 voltios hasta que la impedancia se eleva en aproximadamente 14 segundos. En este punto, el vaso es sellado y la potencia se conmuta manualmente desactivándose. La curva de la impedancia muestra una reducción inicial conforme el vaso se calienta con energía de radiofrecuencia, hasta aproximadamente 20 ohmios. El rápido incremento de aproximadamente 200 ohmios señaliza que el vaso está desecado y que se ha terminado el proceso de sellado.
Los datos mostrados en los gráficos de la figura 17, visualizan el voltaje, corriente, impedancia, potencia y energía durante la activación de 17 segundos, que se consiguen con un sellador o cortador de tejido bipolar tubular alargado, tal como se muestra en la figura 15. Los tiempos de activación abarcan de 12 a 28 segundos. La energía aplicada varía de 170 a 400 joules. La impedancia de contacto varía de 20-80 ohmios, dependiendo de la dimensión y forma del vaso y de la forma de los efectores terminales. Si los efectores terminales de la figura 5 se utilizaran, la impedancia de contacto disminuiría debido a la mayor área de contacto en el vaso. La dimensión del vaso afecta a la impedancia también.
Los vasos fueron examinados perfectamente después de cada sellado y se encontró que no estaban carbonizados. En 2 pruebas de 13 pruebas, el vaso estaba adherido a uno de los efectores terminales. Los análisis histológicos mostraron que las paredes de los vasos estaban completamente soldadas a la integridad de la íntima, adventicia y totalmente perdida la media. Las proteínas estaban fundidas y dando lugar a una soldadura semi-translucida. Adyacente al punto de la soldadura, la pared del vaso estaba relativamente normal.
El sellador o cortador 10 de tejido bipolar tubular alargado preferido para la aplicación de energía electroquirúrgica a
5 un tejido por un cirujano tal como se expone en las reivindicaciones que siguen tienen una estructura que se desliza a lo largo de su eje “A” con una porción deslizante interna y concéntrica. El tubo 19 interno o deslizante interior está fijado a un efector 21 proximal y el tubo o chasis 15 fijado externamente conecta con el efector 22 distal en la realización preferida. Los dos efectores terminales 21 y 22 están acoplados de forma que el efector distal 22 se encaje en forma ajustada contra el efector proximal 21. Estos efectores 21 y 22 pueden ser cualquier número de
10 pares conformados conjugados, incluyendo la forma triangular, esférica, rectangular, con o sin ranura. La ranura no es solo para el alineamiento sino también puede definir un borde afilado para cortar el tejido o vaso por la aplicación de un impulso de RF de alta potencia en el emplazamiento amordazado del tejido entre los efectores 21 y 22. En la realización preferida, el asa 11 es comprimida, de forma que el tubo 19 interior se desliza alejándose del usuario y en donde el chasis 15 está fijo en relación con el tubo interno 19 conforme los efectores 21 y 22 actúan sobre el
15 tejido en la zona intermedia. Por supuesto, ello puede invertirse de forma que el chasis se desplace y en donde el tubo interior 19 esté fijo.

Claims (5)

  1. REIVINDICACIONES
    1. Un instrumento quirúrgico bipolar que está adaptado para conectarse a una fuente de energía radioeléctrica de RF, que comprende:
    un chasis (15) que tiene un eje longitudinal (A) dispuesto a su través;
    una extensión (17) que se extiende desde el chasis teniendo un primer efector (22) fijado al mismo, en donde el primer efector incluye un primer electrodo (26);
    un tubo (19) dispuesto dentro del chasis, teniendo un segundo efector (21) fijado al mismo, e donde el segundo efector incluye un segundo electrodo (20) y el en donde el segundo efector es movible con respecto al chasis, y el primer efector mediante un activador mecánico (32) a lo largo del eje longitudinal para acoplar el tejido entre el primer y segundo electrodos;
    caracterizado porque: el primer y segundo electrodos definen unas superficies (33, 34) de contacto con los vasos complementarios curvilíneos, los cuales se acoplan entre si con el movimiento de los efectores terminales entre si, en donde al menos una de las superficies de contacto con los vasos complementarias tienen una ranura que define un borde afilado de corte del tejido, en donde las superficies de contacto con los vasos curvilíneas complementarias incluyen el borde de corte del tejido afilado configurado para sellar y cortar selectivamente el tejido entre el primer y segundo electrodos dependientes de la energía electroquirúrgica aplicada entre el primer y segundo electrodos; y
    un sensor (31) para medir la impedancia entre el primer y segundo electrodos.
  2. 2.
    El instrumento bipolar de acuerdo con la reivindicación 1, en donde el primer efector es desmontable con respecto a la extensión.
  3. 3.
    El instrumento bipolar de acuerdo con la reivindicación 1, en donde el segundo efector es desmontable del tubo.
  4. 4.
    El instrumento bipolar de acuerdo con cualquiera de las reivindicaciones anteriores, en donde el activador mecánico incluye un asa (11).
  5. 5.
    El instrumento bipolar de acuerdo con cualquiera de las reivindicaciones anteriores, en donde el segundo electrodo está aislado eléctricamente del primer electrodo.
ES05013895T 1997-09-09 1998-09-04 Aparato para sellar y cortar tejido. Expired - Lifetime ES2376063T3 (es)

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ES05015635T Expired - Lifetime ES2349545T3 (es) 1997-09-09 1998-09-04 Instrumento para obturar y cortar tejido.
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AU9223598A (en) 1999-03-29
EP1011492A1 (en) 2000-06-28
DE69832391T2 (de) 2006-08-03
EP1011492A4 (en) 2000-12-20
EP1586280A3 (en) 2005-12-07
ES2349545T3 (es) 2011-01-04
EP1586279B1 (en) 2011-11-02
EP1586279A2 (en) 2005-10-19
DE69841834D1 (de) 2010-09-23
US20060020265A1 (en) 2006-01-26
US6267761B1 (en) 2001-07-31
US6932810B2 (en) 2005-08-23
WO1999012487A1 (en) 1999-03-18
US20050101965A1 (en) 2005-05-12
EP1586279A3 (en) 2005-12-07
ES2248917T3 (es) 2006-03-16
US7270660B2 (en) 2007-09-18
DE69832391D1 (de) 2005-12-22
EP1011492B1 (en) 2005-11-16
EP1586280A2 (en) 2005-10-19
US20080004616A1 (en) 2008-01-03
EP1586280B1 (en) 2010-08-11

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