ES2328965T3 - Sistema para la obturacion de tejidos. - Google Patents

Sistema para la obturacion de tejidos. Download PDF

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ES2328965T3
ES2328965T3 ES07001481T ES07001481T ES2328965T3 ES 2328965 T3 ES2328965 T3 ES 2328965T3 ES 07001481 T ES07001481 T ES 07001481T ES 07001481 T ES07001481 T ES 07001481T ES 2328965 T3 ES2328965 T3 ES 2328965T3
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Darren Odom
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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
    • A61B18/1445—Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
    • 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
    • A61B18/1206—Generators therefor
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00684—Sensing and controlling the application of energy using lookup tables
    • 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
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body

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Abstract

Un fórceps electroquirúrgico bipolar (10) para cerrar un tejido (400), que comprende: al menos un miembro de eje (12) que tiene un conjunto actuador final (100) dispuesto en un extremo distal (14) de él, incluyendo el conjunto actuador final dos miembros de mandíbula (110, 120) que pueden moverse desde una primera posición en relación espaciada de uno con respecto a otro hasta al menos una posición subsiguiente en la que los miembros de mandíbula cooperan para asir el tejido entre ellos a presión constante; incluyendo cada uno de los miembros de mandíbula una placa de cierre conductora de electricidad (112, 122) adaptada para conectarse a una fuente de energía (2) que comunica energía electroquirúrgica a través del tejido sujeto entre ellos, en donde la energía electroquirúrgica se comunica a un voltaje constante; y circuitos del sensor (11) operativamente conectados a las placas de cierre conductoras de electricidad, estando configurados los circuitos del sensor para medir la impedancia inicial del tejido y para transmitir un valor de la impedancia inicial a un controlador (4), caracterizado porque el controlador está configurado para determinar la presión constante y el voltaje constante para aplicar al tejido basándose en el valor de la impedancia inicial.

Description

Sistema para la obturación de tejidos.
Antecedentes Campo técnico
La presente exposición se refiere a un sistema y método electroquirúrgicos para realizar procedimientos electroquirúrgicos. Más particularmente, la presente exposición se refiere al cierre de vasos, en donde la energía es administrada a un voltaje constante predeterminado durante un periodo de tiempo predeterminado.
Antecedentes de la técnica anterior
La electrocirugía implica la aplicación de una corriente eléctrica de frecuencia de radio alta en un sitio de cirugía para cortar, extirpar, o coagular el tejido. En la electrocirugía monopolar, una fuente o electrodo activo suministra energía de radiofrecuencia del generador electroquirúrgico al tejido y un electrodo de retorno lleva la corriente de vuelta al generador. En la electrocirugía monopolar el electrodo fuente es normalmente parte del instrumento quirúrgico que sujeta el cirujano y que aplica al tejido que va a ser tratado. Un electrodo de retorno del paciente se coloca alejado del electrodo activo para llevar la corriente de vuelta al generador.
En electrocirugía bipolar uno de los electrodos del instrumento sujeto por la mano funciona como el electrodo activo y el otro como el electrodo de retorno. El electrodo de retorno está situado muy próximo al electrodo activo, de forma que se forma un circuito eléctrico entre los dos electrodos (por ejemplo, el fórceps electroquirúrgico). De esta forma, la corriente eléctrica aplicada está limitada al tejido corporal situado entre los electrodos. Cuando los electrodos están suficientemente separados entre sí, el circuito eléctrico está abierto y un contacto inadvertido del tejido corporal con cualquiera de los electrodos separados no hace que fluya la corriente.
La electrocirugía bipolar generalmente implica el uso de fórceps. Un fórceps es un instrumento similar a unas pinzas que dependen de la acción mecánica entre sus mandíbulas para asir, apretar y estrechar vasos o tejido. El denominado "fórceps abierto" es comúnmente usado en procedimientos quirúrgicos abiertos en tanto que el "fórceps endoscópico" o "fórceps laparoscópico" es, como su nombre indica, usado en procedimientos quirúrgicos endoscópicos invasivos. El fórceps electroquirúrgico (abierto o endoscópico) utiliza una acción de apriete mecánica y energía eléctrica para efectuar hemostasis en el tejido apretado. El fórceps incluye placas conductoras electroquirúrgicas que aplican energía electroquirúrgica al tejido apretado. Controlando la intensidad, frecuencia y duración de la energía electroqui-
rúrgica aplicada a través de las placas conductoras al tejido el cirujano puede coagular, cauterizar y/o cerrar el tejido.
El cierre de un tejido o de un vaso es un proceso de licuación del colágeno, de la elastina y de las sustancias base en el tejido de manera que puedan convertirse en una masa fundida con una delimitación muy reducida entre las estructuras de tejido opuestas. La cauterización implica el uso de calor para destruir el tejido, y la coagulación es un proceso de desecación del tejido en el que sus células son desgarradas y desecadas.
Como los procedimientos de cierre del tejido implican más que una simple cauterización del tejido, para crear un cierre efectivo los procedimientos implican el control preciso de una variedad de factores. Con el fin de realizar un cierre correcto de los vasos o tejido se ha determinado que se deben controlar con precisión dos importantes parámetros mecánicos: la presión aplicada al tejido; y la distancia y el espacio entre los electrodos (es decir, la distancia entre los miembros opuestos de las mandíbulas cuando las placas opuestas conductoras de electricidad están sobre el tejido).
Muchos de los instrumentos del pasado incluyen elementos de cuchillas o elementos de corte que simplemente cortan el tejido de una forma mecánica y/o electromecánica. La acción de otros instrumentos generalmente se basa en una presión de apriete solamente para procurar el espesor de cierre adecuado y a menudo no están diseñados para tener en cuenta las tolerancias de espacio y/o las exigencias de paralelismo y de planidad que son parámetros que, si se controlan adecuadamente, pueden asegurar un cierre del tejido consistente y efectivo.
Existe una continua necesidad de desarrollar nuevos sistemas y métodos electroquirúrgicos que permitan la creación de cierres de tejido durables capaces de resistir unas mayores presiones de separación.
El documento EP 1.500.578 expone un sistema de cierre electroquirúrgico de un tejido.
Resumen
La presente exposición se refiere a un sistema y método de cierre de un vaso o tejido. En particular, el sistema expone un fórceps bipolar que tiene dos miembros de mandíbula configurados para asir el tejido. Cada uno de los miembros de la mandíbula incluye una placa de cierre que comunica energía electroquirúrgica al tejido. Al comienzo del procedimiento el sistema transmite un impulso interrogativo inicial para determinar la impedancia inicial del tejido. Basándose en la impedancia inicial el sistema determina la presión y el voltaje óptimos, así como la duración de la aplicación de la energía. Durante el procedimiento se aplica una presión inicial al tejido y se aplica una energía electroquirúrgica con un voltaje constante durante un espacio de tiempo predeterminado.
Una realización de acuerdo con el presente invento, y como se expone en la reivindicación 1, se refiere a un fórceps electroquirúrgico bipolar para cerrar el tejido. El fórceps incluye uno o más miembros de eje que tienen un conjunto actuador final dispuesto en el extremo distal. El conjunto actuador final incluye dos miembros de mandíbula que pueden moverse desde una primera posición abierta a una posición cerrada en la que los miembros de mandíbula cooperan para asir el tejido a presión constante. Cada uno de los miembros de mandíbula incluye una placa de cierre conductora de electricidad conectada a una primera fuente de energía que comunica energía electroquirúrgica a través del tejido sujeto entre ellos. La energía electroquirúrgica se comunica a un voltaje constante. Las placas de cierre conductoras de electricidad están operativamente conectadas a los circuitos del sensor que está configurado para medir la impedancia inicial del tejido y para transmitir un valor de la impedancia inicial a un controlador. El controlador determina la presión constante y el voltaje constante que hay que aplicar al tejido basándose en el valor de la impedancia inicial.
Otra realización preferida del presente invento, y expuesta en la reivindicación 8, trata de un sistema electroquirúrgico. El sistema incluye un generador electroquirúrgico para suministrar energía electroquirúrgica y el fórceps bipolar anteriormente descrito para el tejido que se trata.
También se expone, pero no se menciona en las reivindicaciones, un método para cerrar un tejido. El método incluye los pasos de proporcionar un fórceps electroquirúrgico bipolar que incluye uno o más miembros de eje que tienen un conjunto actuador final dispuesto en el extremo distal. El conjunto actuador final incluye dos miembros de mandíbula que pueden moverse desde una primera posición abierta a una posición cerrada en la que los miembros de mandíbula cooperan para asir el tejido a presión constante. Cada uno de los miembros de mandíbula incluye una placa de cierre conductora de electricidad conectada a una fuente de energía que comunica energía electroquirúrgica a través del tejido sujeto entre ellos. La energía electroquirúrgica se comunica a un voltaje constante. El método también incluye los pasos de medir la impedancia inicial del tejido y transmitir un valor de la impedancia inicial a un controlador y determinar la presión constante y el voltaje constante que hay que hay que aplicar al tejido sobre la base del valor de la impedancia inicial.
Breve descripción de los dibujos
A continuación se describen diversas realizaciones de la presente exposición haciendo referencia a los dibujos, en los que:
la Figura 1 es una vista en perspectiva de una realización de un sistema electroquirúrgico de acuerdo con la presente exposición;
la Figura 2 es un diagrama de bloques esquemático de un generador de acuerdo con la presente exposición;
la Figura 3 es una vista en perspectiva desde atrás del actuador final de la Figura 1 mostrado con tejido asido en él;
la Figura 4 es una vista interna, parcial, lateral de un fórceps endoscópico de acuerdo con la presente exposición;
la Figura 5 muestra un diagrama de flujos que muestra un método de cierre que usa el fórceps bipolar endoscópico de acuerdo con la presente exposición;
la Figura 6 muestra un gráfico que ilustra los cambios que ocurren en la impedancia del tejido durante el cierre utilizando el método mostrado en la Figura 5; y
la Figura 7 es una vista en perspectiva de un fórceps bipolar abierto de acuerdo con la presente exposición.
Descripción detallada
A continuación se describirán unas realizaciones particulares del presente invento haciendo referencia a los dibujos que se acompañan. En la siguiente descripción no se describen en detalle funciones o estructuras ya bien conocidas a fin de no entorpecer la presente exposición con detalles innecesarios. Los expertos en la técnica entenderán que el invento de acuerdo con la presente exposición puede ser adaptado para uso bien con un instrumento endoscópico o con un instrumento abierto. Se debería considerar que las diferentes conexiones eléctricas y mecánicas y otras consideraciones se aplican a cada tipo particular de instrumento, sin embargo los aspectos innovadores referentes al cierre de vasos son coherentes con respecto a los diseños abiertos o endoscópicos.
En los dibujos y en la descripción que sigue, el término "próximo" se refiere al extremo del fórceps 10 que está más cerca del usuario, mientras que el término "distal" se refiere al extremo del fórceps que está más alejado del usuario.
La Figura 1 es una ilustración esquemática de un sistema electroquirúrgico 1. El sistema 1 incluye un fórceps electroquirúrgico 10 para tratar el tejido de un paciente. La energía RF electroquirúrgica es suministrada al fórceps 10 por un generador 2 a través de un cable 18 que permite que el fórceps cierre el tejido.
Como se muestra en la Figura 1 el fórceps 10 es un fórceps bipolar endoscópico que cierra el vaso. El fórceps 10 está configurado para soportar un conjunto actuador 100. Más particularmente, el fórceps 10 incluye generalmente un alojamiento 20, un conjunto de empuñadura 30, un conjunto rotativo 80, y un conjunto activador 70 que coopera mutuamente con el conjunto actuador final 100 para asir, cerrar y, si es necesario, dividir el tejido. El fórceps 10 incluye también un eje 12 que tiene un extremo distal 14 que se aplica mecánicamente en el conjunto actuador final 100, y un extremo próximo 16 que se aplica mecánicamente en el alojamiento 20 próximo al conjunto rotativo 80.
El fórceps 10 incluye también un enchufe (no mostrado) que conecta el fórceps 10 a una fuente de energía electroquirúrgica, por ejemplo al generador 2, a través del cable 18. El conjunto de empuñadura 30 incluye una empuñadura fija 50 y una empuñadura móvil 40. La empuñadura móvil 40 se mueve con relación a la empuñadura fija 50 para accionar el conjunto el conjunto actuador final 100 y permitir a un usuario asir y manipular el tejido 400 como se muestra en la Figura 3.
Con respecto a las Figuras 1, 3 y 4, el conjunto actuador final 100 incluye un par de miembros de mandíbula opuestos 110 y 120 teniendo cada uno de ellos una placa de cierre conductora de electricidad 112 y 122, respectivamente, unida a él para conducir energía electroquirúrgica a través del tejido 400 sujeto entre ellas. Más particularmente, los miembros de mandíbula 110 y 120 se mueven como respuesta a un movimiento de la empuñadura 40 desde una posición abierta a una posición cerrada. En la posición abierta las placas de cierre 112 y 122 están dispuestas en relación espaciada una con otra. En una posición de apriete o cerrada las placas de cierre 112 y 122 cooperan para asir el tejido y para aplicar a ellas energía electroquirúrgica.
Los miembros de mandíbula 110 y 120 son activados utilizando un conjunto de impulsión (no mostrado) encerrado en el alojamiento 20. El conjunto de impulsión coopera con la empuñadura móvil 40 para proporcionar movimiento a los miembros de mandíbula 110 y 120 desde la posición abierta a la posición de apriete o cerrada. Ejemplos de conjuntos de empuñadura se muestran y describen en la Solicitud de Patente de propiedad conjunta US 2003-0229344 A1 titulada "Cierrer y divisor de vasos y método de fabricación del mismo", y en la Solicitud de Patente de propiedad conjunta US 7.156.846 titulada "Cierrer y divisor de vasos para uso con pequeños trocares y cánulas".
Los miembros de mandíbula 110 y 120 incluyen también unos alojamientos externos 116 y 126 que conjuntamente con las dimensiones de las placas conductoras 112 y 122 de los miembros de mandíbula 110 y 120 están configurados para limitar y/o reducir muchos de los efectos no deseados relacionados con el cierre del tejido, por ejemplo el salto de la corriente, la dispersión térmica y la disipación de corrientes parásitas.
El conjunto de la empuñadura 30 de esta exposición particular puede incluir un enlace mecánico de cuatro barras que proporciona una única ventaja mecánica al cerrar un tejido entre los miembros de mandíbula 110 y 120. Una vez determinada la posición deseada del sitio de cierre y estando los miembros de mandíbula 110 y 120 correctamente situados, la empuñadura 40 puede ser comprimida totalmente para juntar las placas de cierre conductoras de la electricidad 112 y 122 en una posición cerrada contra el tejido. Los detalles relativos a las relaciones de intercooperación de los componentes que trabajan en el interior de un fórceps previsto 10 se exponen en la Solicitud de Patente de propiedad conjunta anteriormente citada US 2003-0229344 A1. Otro ejemplo de un conjunto de empuñadura endoscópico que tiene una empuñadura tipo palanca descentrada se expone en la patente US 7.156.846 anteriormente citada.
El fórceps 10 también incluye un conjunto rotativo 80 asociado mecánicamente al eje 12 y al conjunto de impulsión (no mostrado). El movimiento del conjunto rotativo 80 proporciona un movimiento rotativo similar al eje 12 que, a su vez, hace rotar el conjunto actuador final 100. Las diversas características junto con las diversas configuraciones eléctricas para la transferencia de la energía electroquirúrgica a través del conjunto de la empuñadura 20 y del conjunto rotativo 80 se describen más detalladamente en la Solicitud de Patente de propiedad común anteriormente mencionada US 2003-0229344 A1 y la Patente US 7.156.846.
Como se puede apreciar mejor con respecto a las Figuras 1 y 4, el conjunto actuador final 100 está unido al extremo distal 14 del eje 12. Los miembros de mordaza 110 y 120 pueden pivotar alrededor de un pivote 160 desde las posiciones abierta a la cerrada con movimiento alternativo, es decir un movimiento longitudinal, del conjunto de impulsión (no mostrado). Nuevamente, las relaciones mecánicas y de cooperación con respecto a los diversos elementos móviles del conjunto actuador final 100 se describen más adelante por ejemplo con respecto a la Solicitud de Patente de propiedad conjunta US 2003-0229344 A1 y la Patente US 7.156.846.
Se ha considerado que el fórceps 10 puede ser diseñado de tal forma que sea total o parcialmente disponible dependiendo de un determinado fin o para conseguir un particular resultado. Por ejemplo, el conjunto actuador final 100 puede ser selectiva y de forma soltable aplicable en el extremo distal 14 del eje 12 y/o el extremo próximo del eje 12 puede ser selectiva y de forma soltable aplicable en el alojamiento 20 y en el conjunto de la empuñadura 30. En cualquiera de estos dos casos el fórceps 10 puede bien ser parcialmente disponible o utilizable, tal como cuando un conjunto actuador final 100 nuevo o diferente o conjunto actuador final 100 y eje 12 se usan para sustituir selectivamente el conjunto actuador final 100 caso de ser necesario.
El generador 2 incluye controles de entrada (por ejemplo, botones, activadores, conmutadores, pantallas táctiles, etc) para controlar el generador 2. Además, el generador 2 incluye una o más pantallas de visualización para proveer al cirujano de diversa información de salida (por ejemplo, graduaciones de intensidad, indicadores de tratamiento completos, etc). Los controles permiten al cirujano ajustar la potencia de la energía RF, la forma de la onda, y otros parámetros para conseguir la forma de onda adecuada deseada para una tarea determinada (por ejemplo, coagulación, cierre de tejido, fijación de la intensidad, etc). También se ha considerado que el fórceps 10 puede incluir una pluralidad de controles de entrada que pueden ser redundantes con ciertos controles del generador 2. Situando los controles de entrada en el fórceps 10 se facilita una mejor y más rápida modificación de los parámetros de la energía RF durante el procedimiento quirúrgico sin necesidad de interacción del usuario en el generador 2.
La Figura 2 muestra un diagrama de bloques esquemático del generador 2 que tiene un controlador 4, un suministro de potencia de corriente continua de alto voltaje 7 ("HVPS"), una etapa de salida RF 8, y unos circuitos del sensor 11. El suministro de potencia de corriente continua 7 proporciona un suministro de potencia de corriente continua 7 a una etapa de salida RF 8 que después convierte la potencia de corriente continua en energía RF y suministra la energía RF al fórceps 10. El controlador 4 incluye un microprocesador 5 conectado operativamente a una memoria 6 que puede ser una memoria de tipo no permanente (por ejemplo, RAM) y/o una memoria de tipo permanente (por ejemplo, medios "flash", medios de disco, etc). El microprocesador 5 incluye un puerto de salida que está conectado operativamente al HVPS 7 y/o a la etapa de salida RF 8 que permite al microprocesador 5 controlar la salida del generador 2 de acuerdo con los esquemas de bucle de control abierto y/o cerrado. Un esquema de control de bucle cerrado puede ser un bucle de control de retroalimentación en el que los circuitos del sensor 11, que puede incluir una pluralidad de mecanismos de detección (por ejemplo, la impedancia del tejido, la temperatura del tejido, la corriente de salida y/o el voltaje, etc), proporcionan una retroalimentación al controlador 4. El controlador 4 avisa entonces al HVPS 7 y/o a la etapa de salida RF 8 que a continuación ajustan la corriente continua y/o el suministro de potencia RF, respectivamente. El controlador 4 recibe también señales de entrada de los controles de entrada del generador 2 y/o del fórceps 10. El controlador 4 utiliza las señales de entrada para ajustar la potencia suministrada por el generador 2 y/o realiza otras funciones de control en él.
Con respecto a esta realización particular, se sabe que el cierre del tejido 400 se lleva a cabo mediante una única combinación de control de separación, presión y control eléctrico. En otras palabras, el control de la intensidad, frecuencia y duración de la energía electroquirúrgica aplicadas al tejido a través de la placa cierrera 112 y 122 son consideraciones eléctricas importantes para cerrar el tejido. Además, dos factores mecánicos desempeñan un papel importante en la determinación del espesor resultante del tejido cerrado y de la efectividad del cierre, esto es la presión aplicada entre los miembros de mandíbula opuestos 110 y 120 (entre aproximadamente 3 kg/cm^{2} hasta aproximadamente 16 kg/cm^{2}) y la separación "G" entre las placas de cierre opuestas 112 y 122 de los miembros de mandíbula 110 y 120, respectivamente, durante el proceso de cierre (entre aproximadamente 0,001 pulgadas hasta 0,006 pulgadas). Uno o más miembros de detención 90 se emplean normalmente en una o ambas placas de cierre para controlar la separación. Se ha determinado recientemente un tercer factor mecánico que contribuye a la calidad y consistencia de un cierre de tejido, o sea la velocidad de cierre de las superficies conductoras de electricidad o de las placas de cierre durante la activación.
Como el fórceps 10 aplica energía a través de electrodos, cada uno de los miembros de mandíbula 110 y 120 incluye un par de placas de cierre eléctricas 112 y 122 respectivamente, dispuestas en una superficie de una cara interior de ellos. De este modo, una vez que los miembros de mandíbula 110 y 120 están completamente comprimidos sobre el tejido 400, el fórceps 10 está ahora preparado para la aplicación selectiva de energía electroquirúrgica como se muestra en la Figura 4. En este punto, las placas de cierre eléctricas 112 y 122 cooperan para cerrar el tejido 400 sujeto entre ellas tras la aplicación de energía electroquirúrgica.
El sistema 1 de acuerdo con la presente exposición regula la aplicación de energía y presión para conseguir un cierre eficaz capaz de resistir altas presiones de separación. El generador 2 aplica energía al tejido a voltaje constante y a presión regulada. La presión se regula cerrando los miembros de mandíbula 110 y 120 a una velocidad predeterminada. La aplicación de la energía es regulada por el controlador 4 de acuerdo con un algoritmo almacenado dentro de la memoria 6. El algoritmo mantiene la energía suministrada al tejido a un voltaje constante. El algoritmo varía la potencia de salida según el tipo de tejido que se está cerrando. Por ejemplo, un tejido más grueso requiere más potencia aplicada sobre él, mientras que un tejido más fino requiere menos. Por lo tanto, el algoritmo ajusta la salida basándose en el tipo de tejido modificando variables específicas (por ejemplo, el voltaje que se está manteniendo durante la aplicación de la potencia, etc).
El algoritmo se discutirá más adelante con más detalle más adelante haciendo referencia a la Figura 5. Además, la Figura 6 muestra un gráfico que ilustra los cambios que se espera que ocurran al colágeno cuando es sometido a un cierre que utiliza el método de la Figura 5.
Durante el paso 300 las placas de cierre 112 y 122 son activadas y están en contacto con el tejido 400 pero no están totalmente cerradas. Cuando las placas de cierre 112 y 122 hacen contacto con el tejido 400, en el paso 302, se aplica un impulso de interrogación al tejido 400. El impulso de interrogación se usa para detectar la impedancia inicial del tejido por medio de los circuitos del sensor 11. El impulso es de pequeño voltaje y de corta duración.
En el paso 304 la impedancia inicial es transmitida al controlador 4 que determina el voltaje óptimo para el procedimiento de cierre y la duración de la aplicación de la energía. En particular, el microprocesador 5 puede usar una tabla de consulta situada en la memoria 6. La tabla de consulta puede tener valores del voltaje y de la duración para una pluralidad de intervalos de impedancia iniciales. Por ejemplo, si la impedancia inicial se mide para ser desde aproximadamente 70 hasta aproximadamente 100 Ohmios, para un intervalo particular la tabla de consulta proporciona el valor óptimo del voltaje de 150 V y con una duración de 30 segundos. El microprocesador 5 extrae los valores de la tabla de consulta y regula en consecuencia el generador 2.
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También se ha considerado que el voltaje y duración óptimos de la aplicación de la energía pueden fijarse manualmente. La impedancia inicial puede ser visualizada en una pantalla de visualización del generador 2 y el cirujano puede fijar el voltaje y duración óptimos de acuerdo con la impedancia inicial medida.
En el paso 305 el fórceps 10 ase y comienza a aplicar presión al tejido 400 usando los miembros de mandíbula 110 y 120. La presión que se aplica se mantiene constante durante todo el procedimiento de cierre como muestra la línea P(t).
Se contemplan diversos métodos y dispositivos para regular automáticamente el cierre de los miembros de mandíbula 110 y 120 sobre el tejido para mantener la presión constante durante el proceso de cierre. Por ejemplo, el fórceps 10 puede ser configurado para incluir un mecanismo de trinquete que inicialmente cierre los miembros de mandíbula 110 y 120 contra el tejido bajo una presión del tejido deseada y después incremente la presión de acuerdo con la orden del microprocesador 5 hasta una presión óptima del tejido. El mecanismo de trinquete está configurado para ajustar la presión basándose en la reacción del tejido. También se ha considerado que la presión pueda ser controlada de una forma similar hacia el final del ciclo de cierre, es decir la presión de liberación. Un mecanismo de trinquete similar o el mismo puede ser empleado también para este fin.
También se han considerado otros mecanismos de cierre controlables que pueden ser asociados con el conjunto de empuñadura 30, con el alojamiento 20 y/o con los miembros de mandíbula 110 y 120 (es decir, mecanismos de engranaje, mecanismos asistidos por presión, mecanismos hidráulicos, mecanismos electromecánicos, etc). Cualquiera de estos mecanismos puede estar alojado en el alojamiento 20 o formar una parte de cada estructura particular.
También se ha considerado que uno o más miembros de detención 90 pueden ser selectivamente controlables para regular la presión de cierre y la distancia de apertura para influir en el cierre. La Solicitud de Patente de propiedad compartida US 2005-0021027 A1 describe un sistema de tope de este tipo que puede usarse para este fin.
En el paso 308 la energía electroquirúrgica se aplica al tejido a un voltaje constante. El colágeno contenido en él se desnaturaliza y se hace más móvil (es decir, se licúa). Simultáneamente, se permite que el agua contenida dentro del tejido 400 se escape del sitio de cierre. Como consecuencia, se reduce la temperatura pico a la que se crea un cierre. Después de esto, el colágeno previamente fundido es mezclado con el fin de facilitar que intervengan sus componentes estructurales (por ejemplo, los polímeros). El mezclado puede conseguirse aplicando energía electroquirúrgica de una frecuencia determinada al sitio de cierre mediante las placas de cierre 112 y 122 a una presión predeterminada. La frecuencia y amplitud óptimas de las ondas depende de las estructuras del colágeno que están siendo mezcladas y pueden ser automáticamente controladas como se ha especificado anteriormente. Una vez que se ha mezclado el colágeno, a continuación es curado mediante la aplicación continua de energía electroquirúrgica y de presión.
La aplicación de energía puede finalizarse cuando ha expirado el periodo de duración predeterminado. Se ha considerado que la aplicación de energía puede detenerse una vez que se ha aplicado al tejido una cantidad de energía predeterminada. De este modo, la misma o diferente tabla de consulta puede también almacenar la energía total para ser aplicada al tejido para crear un cierre. Después de obtenida la impedancia inicial el microprocesador 5 carga el valor de la energía total y en consecuencia ajusta la salida del generador.
La duración de la aplicación de energía puede ser determinada de forma iterativa durante el procedimiento. El microprocesador 5 incluye un reloj que permite que el microprocesador 5 determine la duración de la aplicación de energía durante el proceso de cierre. Se ha considerado además que el controlador 4 puede calcular la cantidad de tiempo que transcurre para que la impedancia inicial descienda y/o el tiempo para que la impedancia suba de nuevo al valor original, mostrándose ambos valores como T_{drop} T_{rise} en el gráfico de la Figura 5.
El algoritmo de acuerdo con la presente exposición favorece la lenta desecación del tejido y que además el colágeno se desnaturalice lentamente. La aplicación de energía durante un periodo relativamente largo de tiempo (por ejemplo, 30 segundos) a voltaje constante permite que el tejido cambie muy lentamente. A medida que avanza la desecación el cierre resultante gana cualidades de tipo plástico, haciéndose duro y claro, lo que hace que el cierre sea capaz de resistir unas mayores presiones de separación.
De todo lo anterior y haciendo referencia a los diversos dibujos de las figuras, los expertos en la técnica apreciarán que en la presente exposición pueden también hacerse ciertas modificaciones sin apartarse del alcance de la misma. Por ejemplo, y como se ha mencionado antes, se ha contemplado que cualquiera de las diversas disposiciones de las mandíbulas expuestas aquí pueden emplearse en un fórceps abierto tal como el fórceps abierto 700 mostrado en la Figura 7. El fórceps 700 incluye un conjunto actuador final 600 que está unido a los extremos distales 516a y 516b de los ejes 512a y 512b, respectivamente. El conjunto actuador final 600 incluye un par de miembros de mandíbula opuestos 610 y 620 que están conectados de forma pivotante sobre un pasador-pivote 665 y que pueden moverse uno con respecto al otro para asir vasos y/o tejido. Cada uno de los miembros de mandíbula opuestos 610, 620 incluye unas placas de cierre eléctrico 112, 122 que permiten que el fórceps abierto 700 sea usado para apretar el tejido para cierre, coagulación o cauterización.
Cada eje 512a y 512b incluye una empuñadura 515 y 517, respectivamente, dispuesta en el extremo próximo 514a y 514b de él, definiendo cada una un agujero para un dedo 515a y 517a, respectivamente, a través de ella para recibir un dedo del usuario. Los agujeros para dedo 515a y 517a facilitan el movimiento de los ejes 512a y 512b entre sí que, a su vez, hacen pivotar los miembros de mandíbula 610 y 620 desde una posición abierta en la que los miembros de mandíbula 610 y 620 están dispuestos en relación espaciada entre sí hasta una posición de apriete o cerrada en la que los miembros de mandíbula 610 y 620 cooperan para asir tejidos o vasos entre ellos. Otros detalles relativos a un fórceps abierto particular se exponen en la Solicitud de Patente de propiedad común US 2005-0154387 A1 presentada el 8 de octubre de 2004 y titulada "Instrumento para cerrar vasos abiertos con mecanismo de corte y cierre por fuera distal".
Mientras en los dibujos se han mostrado y/o discutidos aquí varias realizaciones de la exposición, no se pretende que la exposición esté limitada a ellas, ya que se pretende que la exposición sea tan amplia en alcance como la técnica permita y que la especificación sea interpretada del mismo modo. Por lo tanto, la anterior descripción no debería ser considerada como limitativa, sino solamente como ejemplificaciones de realizaciones particulares. Los expertos en la técnica considerarán otras modificaciones dentro del alcance de las reivindicaciones anejas.

Claims (8)

1. Un fórceps electroquirúrgico bipolar (10) para cerrar un tejido (400), que comprende:
al menos un miembro de eje (12) que tiene un conjunto actuador final (100) dispuesto en un extremo distal (14) de él, incluyendo el conjunto actuador final dos miembros de mandíbula (110, 120) que pueden moverse desde una primera posición en relación espaciada de uno con respecto a otro hasta al menos una posición subsiguiente en la que los miembros de mandíbula cooperan para asir el tejido entre ellos a presión constante;
incluyendo cada uno de los miembros de mandíbula una placa de cierre conductora de electricidad (112, 122) adaptada para conectarse a una fuente de energía (2) que comunica energía electroquirúrgica a través del tejido sujeto entre ellos, en donde la energía electroquirúrgica se comunica a un voltaje constante; y
circuitos del sensor (11) operativamente conectados a las placas de cierre conductoras de electricidad, estando configurados los circuitos del sensor para medir la impedancia inicial del tejido y para transmitir un valor de la impedancia inicial a un controlador (4), caracterizado porque el controlador está configurado para determinar la presión constante y el voltaje constante para aplicar al tejido basándose en el valor de la impedancia inicial.
2. Un fórceps electroquirúrgico bipolar de acuerdo con la reivindicación 1, en el que la energía electroquirúrgica es comunicada durante un periodo de tiempo predeterminado.
3. Un fórceps electroquirúrgico bipolar de acuerdo con la reivindicación 1 ó 2, en el que el controlador está además configurado para determinar la duración de un ciclo de cierre basándose en el valor de la impedancia inicial.
4. Un fórceps electroquirúrgico bipolar de acuerdo con la reivindicación 1, 2 ó 3, en el que el controlador accede a una tabla de consulta que almacena al menos uno de los siguientes datos, la duración, un valor de la presión constante y un valor de voltaje constante, seleccionando el controlador al menos un valor de la duración, el valor de la presión constante y el valor del voltaje constante basándose en el valor de la impedancia inicial.
5. Un fórceps electroquirúrgico bipolar de acuerdo con cualquiera de las reivindicaciones anteriores, que además comprende:
un conjunto rotativo (80) asociado mecánicamente con el miembro de eje, en el que la rotación del conjunto rotativo proporciona un movimiento rotativo similar al miembro de eje y al conjunto actuador final.
6. Un fórceps electroquirúrgico bipolar de acuerdo con cualquiera de las reivindicaciones anteriores, en el que la energía electroquirúrgica que es comunicada hasta una cantidad predeterminada de energía es suministrada al tejido.
7. Un fórceps electroquirúrgico bipolar de acuerdo con la reivindicación 6, en el que el controlador determina la cantidad predeterminada de energía basándose en el valor de la impedancia inicial.
8. Un sistema electroquirúrgico, que comprende:
un generador electroquirúrgico (2) que suministra energía electroquirúrgica; y
un fórceps bipolar de acuerdo con cualquiera de las reivindicaciones anteriores, en el que cada placa de cierre conductora de electricidad está adaptada para conectarse al generador electroquirúrgico como fuente de energía.
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US20090292283A1 (en) 2009-11-26
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DE602007001539D1 (de) 2009-08-27
CA2574865A1 (en) 2007-07-24
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AU2007200271A1 (en) 2007-08-09
JP5362957B2 (ja) 2013-12-11

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