ES2317347T3 - Dispositivo sellador y divisor de tejido con dispositivo sellador y de corte rotatorio. - Google Patents
Dispositivo sellador y divisor de tejido con dispositivo sellador y de corte rotatorio. Download PDFInfo
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- ES2317347T3 ES2317347T3 ES06000707T ES06000707T ES2317347T3 ES 2317347 T3 ES2317347 T3 ES 2317347T3 ES 06000707 T ES06000707 T ES 06000707T ES 06000707 T ES06000707 T ES 06000707T ES 2317347 T3 ES2317347 T3 ES 2317347T3
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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
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B2017/2926—Details of heads or jaws
- A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
- A61B2017/2929—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft with a head rotatable about the longitudinal axis of the shaft
-
- 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
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00404—Blood vessels other than those in or around the heart
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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
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
- A61B2090/034—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself
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- Surgical Instruments (AREA)
Abstract
Un instrumento electroquirúrgico (10) para sellar y dividir tejido, que comprende: un alojamiento (20) que tiene un eje (12) unido al mismo, definiendo el eje (12) un eje geométrico longitudinal (A); miembros de mordaza opuestos primero (110) y segundo (120), acoplados al eje (12), teniendo el primer miembro de mordaza (110) una superficie conductora (112) y siendo movible con relación al segundo miembro de mordaza (120), y estando el segundo miembro de mordaza (120) fijo con relación al eje (12), e incluyendo un electrodo (122) giratorio alrededor del eje geométrico longitudinal (A), incluyendo el electrodo giratorio (122) una primera superficie (134) para sellar tejido, y una segunda superficie (130) para cortar tejido; adaptado cada miembro de mordaza para ser conectado a una fuente (310) de energía electroquirúrgica, tal que los miembros de mordaza sean capaces de conducir selectivamente energía a través del tejido (150) sujeto entre ellos; y al menos un miembro de tope no conductor (140) dispuesto en al menos uno de los miembros de mordaza primero (110) y segundo (120), que controla la distancia de separación entre los miembros de mordaza cuando está sujeto el tejido (150) entre ellos.
Description
Dispositivo sellador y divisor de tejido con
dispositivo sellador y de corte rotatorio.
La presente exposición se refiere a un
instrumento electroquirúrgico para realizar procedimientos
quirúrgicos endoscópicos. Más en particular, la presente exposición
se refiere a unos fórceps electroquirúrgicos bipolares endoscópicos
y a un método para usar los mismos que incluye un ejecutor final que
tiene una mordaza movible y una mordaza fija, incluyendo la mordaza
fija un electrodo giratorio que tiene una superficie de sellado y
un borde de corte. Además, un miembro de tope no conductor está
asociado con uno o con los dos miembros de mordaza opuestos. El
miembro de tope no conductor está diseñado para controlar la
distancia de separación entre los miembros de mordaza opuestos y
mejorar la manipulación y el agarre del tejido durante el proceso de
sellado y de división.
Los fórceps endoscópicos utilizan acción
mecánica para apretar, coger, disecar y/o pinzar tejido. Los fórceps
electroquirúrgicos endoscópicos utilizan tanto la acción de pinzado
mecánico como la energía eléctrica para efectuar la hemostasia
calentando para ello el tejido y los vasos sanguíneos para coagular,
cauterizar y/o sellar el tejido.
Los instrumentos endoscópicos se insertan en el
paciente a través de una cánula, o toma que se haya practicado con
un trocar o con uno de tales dispositivos similares. Los tamaños
típicos para las cánulas oscilan desde tres milímetros a doce
milímetros. Usualmente se prefieren las cánulas más pequeñas, y ello
plantea un reto para los fabricantes de instrumentos en cuanto al
diseño, pues deben encontrar formas de fabricar instrumentos
quirúrgicos que ajusten a través de las cánulas.
Ciertos procedimientos quirúrgicos endoscópicos
requieren cortar vasos sanguíneos o tejido vascular. Sin embargo,
debido a las limitaciones de espacio, los cirujanos pueden tener
dificultades para suturar vasos o realizar otros métodos
tradicionales de control del sangrado, por ejemplo, el pinzado y/o
la ligadura de los vasos sanguíneos que seccionen. Los vasos
sanguíneos que estén en el margen de menos de dos milímetros de
diámetro, pueden frecuentemente cerrarse usando técnicas
electroquirúrgicas estándar. Sin embargo, si se corta un vaso
mayor, puede ser necesario que el cirujano convierta el
procedimiento endoscópico en un procedimiento de cirugía abierta y
renuncie por consiguiente a las ventajas de la laparoscopia.
En varios artículos de revistas se han descrito
métodos para sellar los vasos sanguíneos pequeños usando la
electrocirugía. En un artículo titulado "Studies on Coagulation
and the Development of an Automatic Computerized Bipolar
Coagulator" ("Estudios sobre Coagulación y Desarrollo de un
Coagulador Bipolar Computerizado Automático"), aparecido en J.
Neurosurg., Vol. 75, julio de 1991, se describe un coagulador
bipolar que se usa para sellar vasos sanguíneos pequeños. En el
artículo se afirma que no es posible coagular con seguridad arterias
de un diámetro de más de 2 a 2,5 mm. En un segundo artículo
titulado "Automatically Controlled Bipolar Electrocoagulation"
- "COA-OMP", aparecido en la revista Neurorurg.
(1984), págs. 187-190, se describe un método para
cesar la alimentación de energía electroquirúrgica aplicada al
vaso, de modo que se pueda evitar el chamuscado de las paredes del
vaso.
Como se ha mencionado en lo que antecede,
utilizando unos fórceps electroquirúrgicos, un cirujano puede o
bien cauterizar, o coagular/desecar, y/o simplemente reducir o
ralentizar el sangrado, controlando para ello la intensidad, la
frecuencia y la duración de la alimentación de energía
electroquirúrgica aplicada al tejido a través de miembros de
mordaza. El electrodo de cada miembro de mordaza está cargado a un
potencial eléctrico diferente, de tal modo que cuando los miembros
de mordaza agarran tejido, se puede transferir selectivamente
energía eléctrica a través del tejido.
Con objeto de efectuar un sellado correcto de
los vasos mayores, se han de controlar con precisión dos parámetros
mecánicos predominantes -la presión aplicada al vaso y la distancia
de separación entre los electrodos- que ambos están afectados por
el grosor del vaso sellado. Más en particular, es importante la
aplicación precisa de presión a las paredes opuestas del vaso, para
reducir la impedancia del tejido a un valor suficientemente bajo
que permita que pase suficiente energía electroquirúrgica a través
del tejido; vencer las fuerzas de dilatación durante el
calentamiento del tejido; y contribuir al grosor final del tejido,
el cual es una indicación de un buen sellado. Se ha determinado que
una pared de un vaso fundida típica es óptima entre 0,0254 mm y
0,1524 mm. Por debajo de ese margen, el sello puede desintegrarse o
desgarrarse, y por encima de ese margen puede que los vasos no
queden sellados correcta o efectivamente.
Los métodos electroquirúrgicos pueden servir
para sellar los vasos mayores usando una curva de energía
electroquirúrgica apropiada, acoplada con un instrumento capaz de
aplicar una gran fuerza de cierre a las paredes del vaso. Se piensa
que el proceso de coagulación de vasos pequeños es fundamentalmente
diferente al de sellado electroquirúrgico de un vaso. Para los
fines que aquí se persiguen, la "coagulación" se define como un
proceso de desecación del tejido en el que las células del tejido
se rompen y se desecan. El sellado de un vaso se define como el
proceso de licuación del colágeno que hay en el tejido, de modo que
éste se transforme en una masa fundida. Por consiguiente, la
coagulación de los vasos pequeños es suficiente para cerrar
permanentemente los mismos. Los vasos mayores han de ser sellados
para asegurar un cierre permanente.
La Patente de EE.UU. Nº 2.176.479, concedida a
Willis, las Patentes de EE.UU. Números 4.005.714 y 4.031.898,
concedidas a Hiltebrandt, las Patentes de EE.UU. Números 5.827.274,
5.290.287 y 5.312.433, concedidas a Boebel y otros, las Patentes de
EE.UU. Números 4.370.980, 4.552.143, 5.026.370 y 5.116.332,
concedidas a Lottick, la Patente de EE.UU. Nº 5.443.463 concedida a
Stern y otros, la Patente de EE.UU. Nº 5.484.436, concedida a
Eggers y otros, y la Patente de EE.UU. Nº 5,951.549 concedida a
Richardson y otros, se refieren todas a instrumentos
electroquirúrgicos para coagular, cortar y/o sellar vasos o tejido.
Sin embargo, algunos de estos diseños pueden no proporcionar una
presión reproducible uniformemente en el vaso sanguíneo, y pueden
dar por resultado un sellado ineficaz o no uniforme.
En su mayoría, estos instrumentos se basan en
solamente la presión de pinzado para obtener un apropiado grosor
del sellado, y no están diseñados para tener en cuenta las
tolerancias en la distancia de separación y/o los requisitos de
paralelismo y planeidad, que son parámetros que, debidamente
controlados, pueden asegurar un sellado consistente y efectivo del
tejido. Por ejemplo, es sabido que es difícil controlar
adecuadamente el grosor del tejido sellado resultante, controlando
para ello solamente la presión de pinzado, por una de dos razones:
1) si se aplica demasiada fuerza, existe la posibilidad de que se
toquen los dos polos y que no sea transferida la energía a través
del tejido, lo que da por resultado un sellado no efectivo; o 2) si
se aplica una fuerza demasiado pequeña, el tejido puede moverse
prematuramente antes de la activación y el sellado, y/o se puede
crear un sellado más grueso, menos fiable.
Típicamente, y en particular con respecto a los
procedimientos electroquirúrgicos endoscópicos, una vez sellado un
vaso el cirujano ha de retirar el instrumento de sellar de la zona
de la operación, sustituirlo por un nuevo instrumento a través de
la cánula y cortar con precisión el vaso a lo largo del sellado
recién formado en el tejido. Como puede apreciarse, ese paso
adicional puede llevar mucho tiempo (en particular cuando se sellen
un número significativo de vasos) y puede contribuir a una
separación imprecisa del tejido a lo largo de la línea de sellado,
debido a la desalineación o a una colocación defectuosa del
instrumento de corte a lo largo del centro de la línea de sellado
del tejido.
Se han hecho varios intentos para diseñar un
instrumento que incorpore una cuchilla o miembro de hoja de corte
que corte efectivamente el tejido después de formar un sellado en el
tejido. Por ejemplo, en la Patente de EE.UU. Nº 5.674.220,
concedida a Fox y otros, se describe un instrumento de sellar vasos
transparente que incluye una cuchilla de desplazamiento alternativo
en dirección longitudinal, la cual corta el tejido una vez sellado.
El instrumento incluye una pluralidad de aberturas que hacen posible
la visualización directa del tejido durante el proceso de sellado y
corte. Esa visualización directa permite al usuario regular visual
y manualmente la fuerza de cierre y la distancia de separación entre
los miembros de mordaza para reducir y/o limitar ciertos efectos no
deseables que se sabe que se producen cuando se sellan vasos, como
los de dilatación térmica, chamuscado, etc. Como puede apreciarse,
el éxito en general de crear un sello en un tejido con este
instrumento se basa en gran medida en la pericia, la visión, la
destreza y la experiencia del usuario para juzgar sobre la fuerza
de cierre, la distancia de separación y la longitud del movimiento
alternativo de la cuchilla que sean las apropiadas para sellar
uniforme, consistente y efectivamente el vaso y separar el tejido en
el sello.
En las Patentes de EE.UU. Números 5.702.390 y
5.944.716, concedidas a Austin y otros, se describe un instrumento
para sellar vasos que incluye un electrodo pivotante de forma
triangular que es giratorio desde una primera posición para
coagular tejido, a una segunda posición para cortar el tejido. Como
se ha descrito en lo que antecede, el usuario debe confiar en la
visualización directa y en la pericia para controlar los diversos
efectos del sellado y el corte del tejido. Además, puesto que no hay
medio de controlar la distancia de separación, existe el riesgo de
que los electrodos del instrumento establezcan contacto entre sí,
con independencia de la posición del electrodo de forma triangular,
y produzcan un cortocircuito entre los electrodos que dé por
resultado daños en el instrumento y/o en la fuente de energía
conectada, por ejemplo, en un generador electroquirúrgico. Además,
para cambiar la operación del instrumento de coagular a cortar, se
debe retirar el instrumento de la zona de la operación y se ha de
hacer girar el electrodo, aflojando para ello un tornillo
prisionero, lo que hace que aumente el tiempo de duración y la
complejidad del procedimiento.
Existe, por lo tanto, una necesidad de
desarrollar un instrumento electroquirúrgico endoscópico que selle
y separe de un modo efectivo y consistente el tejido vascular, y
resuelva los antes mencionados problemas. Ese instrumento regula la
distancia de separación entre los miembros de mordaza opuestos,
reduce las posibilidades de cortocircuitos entre las mordazas
opuestas durante la activación, y ayuda a la manipulación, el agarre
y la sujeción del tejido antes de, y durante, la activación y la
separación del tejido.
De acuerdo con un aspecto de la presente
exposición, un instrumento electroquirúrgico para sellar y dividir
tejido incluye un alojamiento que tiene un eje unido al mismo, el
cual define un eje geométrico longitudinal. Miembros de mordaza
opuestos primero y segundo están acoplados al eje, teniendo el
primer miembro de mordaza una superficie conductora y siendo
movible con relación al segundo miembro de mordaza, y estando el
segundo miembro de mordaza fijado con relación al eje y teniendo un
electrodo conductor giratorio a lo largo del eje geométrico
longitudinal. El electrodo giratorio incluye una superficie de
sellar en un lado del mismo, y un borde de corte en un segundo lado
del mismo. Una fuente de energía electroquirúrgica está conectada a
cada miembro de mordaza, de tal modo que los miembros de mordaza
son capaces de conducir energía a través del tejido sujeto entre
ellos. El instrumento electroquirúrgico incluye también al menos un
miembro de tope no conductor asociado para funcionamiento con al
menos uno de los miembros de mordaza primero y segundo, el cual
controla la distancia, por ejemplo, una distancia de separación,
entre los miembros de mordaza cuando se sujeta tejido entre ellos.
En otro aspecto, la distancia de separación entre los miembros de
mordaza es fija. La distancia de separación está típicamente
comprendida entre aproximadamente 0,0254 mm movible y
aproximadamente 0,1524 mm.
El instrumento electroquirúrgico incluye además
un conjunto giratorio para hacer girar al electrodo del segundo
miembro de mordaza y/o para hacer girar al segundo miembro de
mordaza. El conjunto giratorio incluye un cuadrante indicador
dispuesto dentro del alojamiento para establecer una posición
deseada del electrodo y un tubo alargado dispuesto dentro del eje
que copla el cuadrante indicador al electrodo. El cuadrante
indicador orienta selectivamente al electrodo del segundo miembro
de mordaza desde una primera posición operable, en la que la
superficie de sellado del electrodo es en general paralela a la
superficie conductora del primer miembro de mordaza para sellar
tejido, a una segunda posición operable en la que el borde de corte
del electrodo es en general perpendicular a la superficie
conductora del primer miembro de mordaza para dividir tejido.
De acuerdo con otro aspecto de la presente
exposición, los fórceps incluyen un alojamiento que tiene un eje
unido al mismo, definiendo el eje un eje geométrico longitudinal.
Miembros de mordaza opuestos primero y segundo están acoplados al
eje. El primer miembro de mordaza incluye una superficie conductora,
y es movible con respecto al segundo miembro de mordaza, y el
segundo miembro de mordaza es fijo con respecto al eje e incluye un
electrodo giratorio a lo largo del eje geométrico longitudinal. El
electrodo giratorio incluye una superficie de sellado y un borde de
corte. Al menos un miembro de tope no conductor está dispuesto en al
menos uno de los miembros de mordaza primero y segundo, y el cual
controla la distancia entre los miembros de mordaza cuando está
sujeto el tejido entre ellos. Está incluido un conjunto giratorio
que hace girar al electrodo del segundo miembro de mordaza desde
una primera posición operable, en la que la superficie de sellado
del electrodo es en general paralela a la superficie conductora del
primer miembro de mordaza para sellar tejido, a una segunda posición
operable en la que el borde de corte del electrodo es en general
perpendicular a la superficie conductora del primer miembro de
mordaza para dividir tejido.
Un método para sellar y dividir tejido
utilizando un instrumento de acuerdo con el presente invento incluye
los pasos de:
proporcionar un instrumento electroquirúrgico
que comprende un alojamiento que tiene:
un eje unido al mismo, que define un eje
geométrico longitudinal;
miembros de mordaza opuestos primero y segundo
acoplados al eje, teniendo el primer miembro de mordaza una
superficie conductora y siendo movible con respecto al segundo
miembro de mordaza, y estando el segundo miembro de mordaza fijo
con respecto al eje y teniendo un electrodo giratorio a lo largo del
eje geométrico longitudinal, teniendo el electrodo giratorio una
superficie de sellado y un borde de corte; y
al menos un miembro de tope no conductor
dispuesto en al menos uno de los miembros de mordaza primero y
segundo, el cual controla distancia entre los miembros de mordaza
cuando está sujeto tejido entre ellos;
situar la superficie de sellado del electrodo
giratorio ara que sea en general paralela a la superficie conductora
del primer miembro de mordaza;
aproximar el tejido, cerrando para ello los
miembros de mordaza primero y segundo;
aplicar energía electroquirúrgica a los miembros
de mordaza primero y segundo para sellar el tejido;
abrir los miembros de mordaza primero y segundo
y modificar la posición del electrodo de modo que el borde de corte
quede en general perpendicular a la superficie conductora del primer
miembro de mordaza; y
cerrar los miembros de mordaza primero y segundo
sobre el sello en el tejido y aplicar energía electroquirúrgica
para dividir el tejido en el sello.
Se describen aquí varias realizaciones del
instrumento de que se trata, con referencia a los dibujos, en los
que:
La Fig. 1 es una vista en perspectiva de unos
fórceps endoscópicos en la que se muestra un mango y un ejecutor
final, de acuerdo con la presente exposición;
La Fig. 2A es una vista en perspectiva por la
izquierda, ampliada, del conjunto ejecutor final con los miembros
de mordaza representados en una configuración de abiertos para
sellar vasos;
La Fig. 2B es una vista en perspectiva por la
izquierda, ampliada, del conjunto ejecutor final con los miembros
de mordaza representados en una configuración de abiertos para
cortar vasos;
La Fig. 3A es una vista por un extremo del
conjunto ejecutor final de la Fig. 2A, en la que se han representado
las superficies conductoras en una configuración para sellar
vasos;
La Fig. 3B es una vista por un extremo del
conjunto ejecutor final de la Fig. 2B, en la que se han representado
las superficies conductoras en una configuración para cortar
vasos;
La Fig. 4 es una vista lateral, ampliada, del
conjunto ejecutor final;
La Fig. 5 es una vista en perspectiva ampliada
del conjunto giratorio;
La Fig. 6A es una vista en perspectiva ampliada
de un lugar de sellado en un vaso tubular;
La Fig. 6B es un corte trasversal longitudinal
del lugar de sellado, dado a lo largo de la línea
6B-6B de la
Fig. 6A; y
Fig. 6A; y
La Fig. 6C es una vista en corte transversal
longitudinal del lugar de sellado de la Fig. 6A, después de la
separación del vaso tubular.
Pasando ahora a las diversas figuras, se ha
representado una realización de unos fórceps bipolares endoscópicos
10 para uso en varios procedimientos quirúrgicos, y que incluye en
general un alojamiento 20, un conjunto de mango 30, un conjunto
giratorio 80, y un conjunto ejecutor final 100, los cuales cooperan
mutuamente para agarrar, sellar y dividir vasos tubulares y tejido
vascular 150 (Fig. 6A). Aunque la mayor parte de los dibujos de las
figuras representan unos fórceps bipolares 10 para uso en relación
con procedimientos quirúrgicos endoscópicos, la presente exposición
puede ser usada para procedimientos quirúrgicos de cirugía abierta,
más tradicionales. Para los fines que aquí se persiguen, los
fórceps 10 se describen en términos de un instrumento endoscópico,
aunque está contemplado que una versión de los fórceps para cirugía
abierta pueda también incluir los mismos o similares componentes y
características operativas, como se describe en lo que sigue.
Los fórceps 10 incluyen un eje 12 que tiene une
extremo distal 16 dimensionado para aplicarse mecánicamente al
conjunto ejecutor final 100, y un extremo proximal 14 que se aplica
mecánicamente al alojamiento 20. En los dibujos y en las
descripciones que siguen, el término "proximal" se referirá,
como es tradicional, al extremo de los fórceps 10 que está más
próximo al usuario, mientras que el término "distal" se
referirá al extremo que está más alejado del usuario. Además. el
eje 12 define un eje geométrico longitudinal "A" a través de
los fórceps 10.
Como se ve mejor en la Fig. 1, los fórceps 10
incluyen también un cable electroquirúrgico 310 que conecta los
fórceps 10 con una fuente de energía electroquirúrgica, por ejemplo,
con un generador (no representado). Se usan generadores tales como
los comercializados por la firma Valleylab -una división de la Tyco
Healthcare LP, con sede en Boulder, Colorado (EE.UU.), como fuente
de energía electroquirúrgica, por ejemplo, el Generador
Electroquirúrgico FORCE EZ^{TM}, el Generador Electroquirúrgico
FORCE FX^{TM}, el FORCE 1C^{TM}, el Generador FORCE 2^{TM},
y el SurgiStat^{TM} II. Uno de tales sistemas se ha descrito en la
Patente de EE.UU. Nº 6.033.399, de propiedad común, titulada
"ELECTROSURGICAL GENERATOR WITH ADAPTIVE POWER CONTROL"
(Generador Electroquirúrgico con Control de Potencia Adaptativo).
Otros sistemas se han descrito en la Patente de EE.UU. Nº
6.187.003, de propiedad común, titulada "BIPOLAR ELECTROSURGICAL
INSTRUMENT FOR SEALING VESSELS" (Instrumento Electroquirúrgico
Bipolar para Sellar Vasos).
El generador incluye varias características de
seguridad y de actuaciones, que incluyen salida aislada y activación
independiente de accesorios. El generador electroquirúrgico incluye
características de la tecnología de Instant Response^{TM} de
Valley lab, las cuales proporcionan un sistema de realimentación
avanzado para percibir los cambios en el tejido 200 veces por
segundo y ajustar el voltaje y la corriente para mantener una
potencia apropiada. Se cree que la tecnología Instant
Response^{TM} proporciona uno o más de los siguientes beneficios
para el procedimiento quirúrgico:
* Efecto clínico consistente para todo tipo de
tejidos;
* Dilatación térmica y riesgo de daños
colaterales en tejidos reducidos;
* Menor necesidad de "conectar el
generador" y
* Diseñado para un ambiente mínimamente
invasivo.
\vskip1.000000\baselineskip
El cable 310 está dividido internamente en una
pluralidad de conductores 310a, 210b, 310c del cable, que cada uno
transmite energía electroquirúrgica a través de sus respectivos
caminos de alimentación a través de los fórceps 10 hasta el
conjunto ejecutor final 100, como se explica con más detalle en lo
que sigue.
El conjunto de mango 30 incluye un mango fijo 50
y un mango movible 40. El mango fijo 50 está asociado integralmente
con el alojamiento 20, y el mango 40 es movible con respecto al
mango 150, como se explica con más detalle en lo que sigue en
relación con la operación de los fórceps 10. El conjunto giratorio
80 puede estar asociado integralmente con el alojamiento 20, y es
giratorio en aproximadamente 180 grados en uno u otro sentido,
alrededor del eje geométrico longitudinal
"A-A". Los detalles del conjunto giratorio 80
se describen con más detenimiento con respecto a las Fig. 2A, 2B,
3A, 3B y 5.
Como se ha mencionado en lo que antecede, el
conjunto ejecutor final 100 está unido al extremo distal 16 del eje
12 e incluye un par de miembros de mordaza opuestos 110 y 120, como
se ha ilustrado en las Figs. 2A y 2B. El mango movible 40 del
conjunto de mango 30 está finalmente conectado a un conjunto de
accionamiento (no representado) y los cuales, juntos, cooperan
mecánicamente para comunicar movimiento a los miembros de mordaza
110 y 120 desde una posición de abiertos, en la que los miembros de
mordaza 110 y 120 están dispuestos en relación de espaciados cada
uno con respecto al otro, a una posición de pinzado o de cerrados,
en la que los miembros de mordaza 110 y 120 cooperan para agarrar
tejido 150 (Fig. 6B) entre ellos, o para cortar tejido (Fig. 6C).
Las funciones específicas y las relaciones operativas de estos
elementos y los diversos componentes de trabajo internos de los
fórceps 10 se han descrito con más detalle en la Publicación de
Patente concedida en común US 2004-0254573 A1,
titulada "VESSEL SEALER AND DIVIDER FOR USE WITH SMALL TROCARS AND
CANULAS" (Sellador y Divisor de Vasos para Uso con Trocares
Pequeños y Cánulas) de Dycus y otros.
Está contemplado que los fórceps 10 puedan ser
diseñados de tal modo que sean total o parcialmente desechables,
dependiendo de la finalidad particular que se persiga o de que se
quiera conseguir un resultado particular. Por ejemplo, el conjunto
ejecutor final 100 puede ser susceptible de aplicación selectiva y
liberablemente con el extremo distal 16 del eje 12 y/o el extremo
proximal 14 del eje 12 puede ser susceptible de aplicación
selectiva y liberablemente con el alojamiento 20 y con el conjunto
de mango 30. En cualquiera de estos dos casos, los fórceps 10
serían considerados como "parcialmente desechables" o
"reemplazables", es decir, que un conjunto ejecutor final 100
nuevo o diferente (o un conjunto ejecutor final 100 y eje 12)
reemplazan selectivamente al conjunto ejecutor final 100 antiguo,
cuando sea necesario. Como puede apreciarse, las conexiones
eléctricas que actualmente se exponen tendrían que ser alteradas
para modificar el instrumento para unos fórceps reemplazables.
Como se ha ilustrado mejor en las Figs. 2A y 2B,
el conjunto ejecutor final 100 incluye miembros de mordaza opuestos
110 y 120 que cooperan para agarrar efectivamente tejido 150 para
fines de sellado, y para dividir el tejido 150 una vez sellado. El
conjunto ejecutor final 100 está diseñado como un conjunto
unilateral, es decir, que el miembro de mordaza 120 es fijo con
respecto al eje 12, y el miembro de mordaza 110 pivota alrededor de
un pasador de pivote 103, para agarrar el tejido 150.
Más en particular, el conjunto ejecutor final
100 unilateral incluye un miembro de mordaza estacionario o fijo
120 montado en relación de fijo con respecto al eje 12, y el miembro
de mordaza pivotante 110 montado alrededor de un pasador de pivote
103 unido al miembro de mordaza estacionario 120. Un manguito 60 de
movimiento alternativo está dispuesto para deslizamiento dentro del
eje 12 y es operable a distancia mediante el conjunto de
accionamiento (no representado). En la antes mencionada Publicación
de Patente de EE.UU. US 2004-0254573 A1 se describe
un ejemplo de un conjunto de accionamiento que puede ser utilizado
para este fin. El miembro de mordaza pivotante 110 incluye un
fiador o saliente 117 que se extiende desde el miembro de mordaza
110, a través de una abertura 62 dispuesta dentro del manguito de
movimiento alternativo 60. El miembro de mordaza pivotante 110 es
accionado mediante el deslizamiento del manguito 60 axialmente
dentro del eje 12, de tal modo que un extremo distal 63 de la
abertura 62 apoya a tope contra el fiador 117 sobre el miembro de
mordaza pivotante 110 (véase la Fig. 4). Tirando del manguito 60 en
dirección proximal, se cierran los miembros de mordaza 110 y 120
alrededor del tejido 150 cogido entre ellos, y empujando el manguito
60 en dirección distal se abren los miembros de mordaza 110 y 120
para fines de agarre.
Como se aprecia mejor en la Fig. 2A, el miembro
de mordaza 110 incluye también un alojamiento de mordaza 116 que
tiene un sustrato aislante o aislador 114 y una superficie
conductora eléctrica 112. El aislador 114 está dimensionado,
preferiblemente, para aplicarse con seguridad a la superficie de
sellado conductora eléctrica 112. Esto puede conseguirse por
estampación, por sobremoldeo, por sobremoldeo de una placa de
sellado conductora eléctrica estampada, y/o por sobremoldeo de una
placa de sello metálica moldeada por inyección.
Por todas estas técnicas de fabricación se
produce el miembro de mordaza 110 que tiene una superficie
conductora eléctrica 112 que está sustancialmente rodeada por un
sustrato aislante 114. El aislador 114, la superficie de sellado
conductora eléctrica 112 y el alojamiento de mordaza no conductor
exterior 116 pueden estar dimensionados para limitar y/o reducir
muchos de los efectos no deseables conocidos relacionados con el
sellado de tejido, por ejemplo, el salto de arco, la dilatación
térmica y la disipación de las corrientes parásitas. Como
alternativa, está también contemplado que el miembro de mordaza 110
pueda ser fabricado de un material similar a la cerámica, y que la
superficie conductora eléctrica 112 esté recubierta sobre los
miembros de mordaza similares a cerámica 110.
Está contemplado que la superficie de sellado
conductora eléctrica 112 pueda incluir también un borde periférico
exterior que tenga un radio predefinido y que el aislador 114
encuentre a la superficie de sellado conductora eléctrica 112 a lo
largo de un borde contiguo de la superficie de sellado 112 en una
posición en general tangencial. Preferiblemente, en la interfaz, la
superficie conductora eléctrica 112 está elevada en relación con el
aislador 114. Estas y otras realizaciones contempladas se analizan
en la Publicación de Patente de EE.UU. cedida en común pendiente de
tramitación junto con la presente, WO 2002/080786 titulada
"ELECTROSURGICAL INSTRUMENT WHICH REDUCES COLLATERAL DAMAGES TO
ADJACENT TISSUE" (Instrumento Electroquirúrgico que Reduce los
Daños Colaterales al Tejido Adyacente) de Johnson y otros, y en la
Publicación de Patente de EE.UU. cedida en común pendiente de
tramitación junto con la presente WO 2002/080785, titulada
"ELECTROSURGICAL INSTRUMENT WHICH IS DESIGNED TO REDUCE THE
INCIDENCE OF FLASHOVER" (Instrumento Electroquirúrgico que está
Diseñado para Reducir la Incidencia de Saltos de Arco) de Johnson y
otros.
El miembro de mordaza 120 incluye elementos
similares a los del miembro de mordaza 110, tales como el
alojamiento de mordaza 126, que tiene un aislador 124. A diferencia
del miembro de mordaza 110, el miembro de mordaza 120 incluye un
electrodo giratorio 122. El electrodo giratorio 122 tiene al menos
dos posiciones operables. Una primera posición se emplea durante el
sellado de vasos, y una segunda posición se emplea durante la
división o corte de vasos. Como puede verse mejor en las Figs. 3A y
3B, el electrodo giratorio 122 incluye tres superficies, a saber:
una primera superficie 134, una segunda superficie 136 y una tercera
superficie 138.
Con referencia a la Fig. 3A, cuando está en una
primera posición operable, la primera superficie 134 del electrodo
122 es en general y sustancialmente paralela a la superficie de
sellado conductora 112 del primer miembro de mordaza 110. En esa
posición, la primera superficie 134 y la superficie de sellado
conductora 112 facilitarán el agarre del tejido. Al tener lugar la
activación de energía electroquirúrgica y al ser aplicada presión
dentro del margen previamente definido de aproximadamente 3
kg/cm^{2} a aproximadamente 16 kg/cm^{2} y al agarrar el tejido
dentro de un margen de distancia de separación previamente definido
de aproximadamente 0,0254 mm a aproximadamente 0,1524 mm, y
preferiblemente desde aproximadamente 0,0508 mm a aproximadamente
0,1016 mm, el tejido dispensado entre los miembros de mordaza
quedará sellado en una sola masa fundida con una demarcación
limitada entre capas de tejido. Como se explica con más detalle en
lo que sigue, una serie de miembros de tope están asociados
operativamente con al menos uno de los miembros de mordaza para
mantener una distancia de separación "G" (Fig. 6A) entre las
superficies que contienen tejidos opuestas 112 y 134. Como se
explica en la antes identificada Publicación de Patente de EE.UU. US
200-0254573 A1, el mango 40 y el mango fijo 50
incluyen un mecanismo de acción de leva que, al ser activado,
mantiene la presión entre las superficies de sellado opuestas en un
valor comprendido entre aproximadamente 3 kg/cm^{2} y
aproximadamente 16 kg/cm^{2}. La Publicación de Patente de EE.UU.
US 2005-0203504 A1 y la Patente de EE.UU. Nº
7.137.980 incluyen detalles que sirven de ejemplos relativos a los
diversos parámetros eléctricos que han de ser estrechamente
vigilados y controlados para optimizar el proceso de sellado de
vasos, para varios grosores de tejido y tipos de tejido.
Con referencia a la Fig. 3B, la segunda
superficie 136 y la tercera superficie 138 del electrodo 122 se
encuentran para formar el borde de corte 130. Cuando se hacen girar
los fórceps selectivamente a la segunda posición operable, el borde
de corte 130 es en general perpendicular a una superficie de sellado
112. Cuando se mueven los miembros de mordaza 110, 120 a una
posición de cerrados, el borde de corte 130 queda en estrecha
proximidad a la superficie de sellado 112 para cortar o separar
electromecánicamente el tejido sellado, como se describirá en
relación con la Fig. 1C.
Como se ha mencionado en lo que antecede, el
electrodo giratorio 122 (y/o el miembro de mordaza 110 de la
superficie de sellado 112) incluye al menos uno, y preferiblemente
una pluralidad, de miembros de tope 140 asociados operativamente
con la primera superficie 134 del electrodo 122. Los miembros de
tope 140 están configurados para definir un espacio de separación
"G" (Fig. 6A) entre las superficies de sellado opuestas 112 y
134 de los miembros de mordaza 110 y 120 durante el sellado del
tejido. Está contemplado que se puedan emplear una serie de
miembros de tope 140 en uno o en los dos miembros de mordaza 110 y
120 (y/o en las superficies de sellado 112 y 134) dependiendo de la
finalidad particular que se persiga o del resultado que se desee
conseguir. Un estudio detallado de estos y otros miembros de tope
140 contemplados, así como de varios procesos de fabricación y
montaje para unir y/o fijar los miembros de tope 140 a los miembros
de mordaza 110, 120, se han descrito en la Publicación cedida en
común y pendiente de tramitación juntamente con la presente,
titulada "VESSEL SEALER AND DIVIDER WITH NON CONDUCTING STOP
MEMBERS" (Sellador y Divisor de Vasos con Miembros de Tope no
Conductores) de Dycus y otros.
Los miembros de tope 140 están fijados/unidos al
miembro o miembros de mordaza por estampación, por rociado térmico,
por sobremoldeo y/o mediante un adhesivo. Los miembros de tope se
proyectan desde aproximadamente 0,0254 mm hasta aproximadamente
0,1524 mm, y, preferiblemente, desde aproximadamente 0,0508 mm hasta
aproximadamente 0,1016 mm desde la superficie que mira hacia el
interior de al menos uno de los miembros de mordaza. Está
contemplado que los miembros de tope puedan fabricarse de un
material aislante, tal como de parileno, de nilón y/o de cerámica.
Se han contemplado también otros materiales, por ejemplo, los
polietilenos sindiotácticos, tales como el QUESTRA® fabricado por
la DOW Chemical, el poliestireno sindiotáctico (SPS), el
poli(tereftalato de butileno) (PBT), el policarbonato (PC)
el Acrilonitrilo Butadieno Estireno (ABS), la Poliftalamida (PPA),
la Poliimida, el Poli(tereftalato de etileno) (PET), la
Poliamida-imida (PAI), la Acrílica (PMMA), el
Poliestireno (PS y HIPS), la Poliéter Sulfona (PES), la Policetona
Alifática, el Copolímero de Acetal (POM), el Poliuretano (PU y
TPU), la dispersión de Nilón con Óxido de Polifenileno, y el
Acrilato de Acrilonitrilo Estireno.
Como se explica en detalle en lo que sigue y
como se aprecia mejor en la Fig. 5, el electrodo giratorio 122 está
diseñado para ser fijado al extremo de un tubo giratorio 162 que es
parte del conjunto giratorio 80, de tal modo que la rotación del
tubo 162, por m3dio del cuadrante indicador 82, comunicará rotación
al electrodo 122. En contraste con la Publicación de Patente de
EE.UU. US 2004-0254573 A1, el conjunto giratorio
está diseñado para hacer que gire el electrodo 122 y no el conjunto
ejecutor final 100. Más en particular, el tubo giratorio 162
incluye una ranura de guía alargada 160 dispuesta en una parte
superior del mismo, que está dimensionada para conducir a lo largo
de la misma el conductor 310a. El conductor 210a lleva un primer
potencial eléctrico a la mordaza movible 110. Como se explica con
más detalle en lo que sigue, con respecto a las conexiones
eléctricas internas de los fórceps, una segunda conexión eléctrica
desde el conductor 310c es conducida a través de un tubo 160 al
electrodo 134 del miembro de mordaza fija 120.
Los conductores eléctricos 310a, 310b, 310c y
311 son alimentados a través del alojamiento 20 por el cable
electroquirúrgico 310. Más en particular, el cable electroquirúrgico
310 es alimentado a la parte inferior del alojamiento 20 a través
del mango fijo 50. El conductor 310c se extiende directamente desde
el cable 310 adentro del conjunto giratorio 80 y conecta con el
electrodo 122 para conducir el segundo potencial eléctrico al
miembro de mordaza fija 120. Los conductores 310a y 310b se
extienden desde el cable 310 y conectan con el conmutador manual o
con el conmutador de dos direcciones o de palanca 200. Las funciones
específicas y las relaciones operativas de estos elementos y de los
varios componentes de trabajo internos de los fórceps 10 se han
descrito con más detalle en la Publicación de Patente de EE.UU.
cedida en común y pendiente de tramitación junto con la presente US
2004-0254573 A1, titulada "VESSEL SEALER AND
DIVIDER FOR USE WITH SMALL TROCARS AND CANNULAS" (Sellador y
Divisor de Vasos para Uso con Trocares Pequeños y Cánulas) de Dycus
y otros.
Cuando se oprime el conmutador 200, se
transfiere energía electroquirúrgica a través de los conductores
310a y 310c a los miembros de mordaza 110 y 12, respectivamente.
Está contemplado que se pueda emplear un conmutador o circuito de
seguridad (no representado) tal que el conmutador no pueda actuar a
menos que los miembros de mordaza 110 y 120 estén cerrados y/o a
menos que los miembros de mordaza 110 y 120 tengan sujeto entre
ellos tejido 150. En este último caso, se puede emplear un sensor
(no representado) para determinar si está sujeto tejido 150 entre
ellos. Además, se pueden emplear otros mecanismos de sensor que
determinen las condiciones quirúrgicas (es decir, durante la
cirugía) y/o post quirúrgicas que concurran. Todavía otros
mecanismos de sensor, por ejemplo, un conmutador de palanca o
similar, pueden ser situados en el tubo 162 para determinar la
posición relativa del electrodo 122, es decir, la activación del
sellado o la activación del corte.
Los mecanismos de sensor pueden también ser
utilizados con un sistema de realimentación de bucle cerrado
acoplado al generador electroquirúrgico para regular la energía
electroquirúrgica en base a una o más condiciones pre
electroquirúrgicas, o quirúrgicas o post quirúrgicas concurrentes.
Se han descrito varios mecanismos de sensor y sistemas de
realimentación en la Patente de EE.UU. cedida en común, pendiente de
tramitación junto con la presente, Nº 7.137.980 titulada "METHOD
AND SYSTEM FOR CONTROLLING OUTPUT OF RF MEDICAL GENERATOR"
(Método y Sistema para Controlar la Salida de un Generador de RF
Médico), concedida con fecha 21 de noviembre de 2006.
Está contemplado que los conductores 310a y 310c
del cable sean alimentados a través de respectivas mitades 82a y
82b del conjunto giratorio 80, de tal manera que permitan la
rotación del eje 162 (por medio de la rotación del conjunto
giratorio 80) en sentido a derechas o a izquierdas, sin enredos ni
retorcimientos indebidos de los conductores 310a y 310c del cable.
Más en particular, cada conductor 310a y 310c del cable es
alimentado a través de una serie de ranuras contiguas, por ejemplo,
84, situadas en las dos mitades 82a y 82b del conjunto giratorio
80. Cada par de ranuras contiguas son lo suficientemente grandes
como para permitir la rotación del conjunto giratorio 80 sin
forzamiento ni enredo indebidos de los conductores 310a y 310c del
cable. El camino de alimentación de los conductores del cable
actualmente descrito está contemplado para permitir la rotación del
conjunto de rotación aproximadamente 180 grados en uno u otro
sentido, lo que, a su vez, hace girar al electrodo 122 desde una
primera posición para sellar tejido a una segunda posición para
cortar el tejido.
En las Figs. 6A a 6C se ha ilustrado el sellado
y el corte de tejido empleando los fórceps 10 de acuerdo con la
presente exposición. Antes de aproximar el tejido, el usuario
seleccionará una posición operable del electrodo giratorio 122 por
medio del conjunto giratorio 80. Aquí, se coloca el electrodo 122 en
la primera posición operable para efectuar el sellado del vaso
donde la primera superficie 134 es en general paralela a la
superficie de sellado 112 (véase la Fig. 3A). Al oprimir el mango
40, se tira del manguito 80 de movimiento alternativo en la
dirección proximal, lo que, a su vez, hace que la abertura 82 del
manguito 60 se desplace en la dirección proximal al fiador 117 de
leva y cierre el miembro de mordaza 110 con relación al miembro de
mordaza 120. La carga del manguito de movimiento alternativo 60 es
convertida en un par de torsión alrededor del pivote de mordaza
103. Como resultado, se puede transmitir una fuerza de cierre
específica a los miembros de mordaza opuestos 110 y 120,
comprendida entre aproximadamente 3 kg/cm^{2} y aproximadamente 16
kg/cm^{2}.
Como puede apreciarse y como se ha analizado en
la Publicación de Patente de EE.UU. Nº US
2004-0254573 A1, la combinación única de la ventaja
mecánica del pivote de centrado, juntamente con la fuerza de
compresión asociada con el conjunto de accionamiento, facilitan y
aseguran una presión de cierre consistente, uniforme y precisa,
alrededor del tejido 150 dentro del margen de presiones de trabajo
deseado de aproximadamente 3 kg/cm^{2} a aproximadamente 16
kg/cm^{2} y, preferiblemente, entre aproximadamente 7 kgcm^{2} y
aproximadamente 13 kg/cm^{2}. Controlando la intensidad, la
frecuencia y la duración de la energía electroquirúrgica aplicada
al tejido 150, el usuario puede sellar el tejido. Como se ha
mencionado en lo que antecede, dos factores mecánicos desempeñan un
papel importante en la determinación del grosor resultante del
tejido sellado, y en la eficacia del sellado 150, es decir, la
presión aplicada entre los miembros de mordaza opuestos 110 y 120 y
la distancia de separación "G" entre las superficies de
sellado opuestas 112, 134 de los miembros de mordaza 110 y 120
durante el proceso de sellado. Sin embargo, el grosor del sello del
tejido resultante 152 no puede ser controlado adecuadamente con
solamente la fuerza, en otras palabras, con demasiada fuerza los dos
miembros de mordaza 110 y 120 se tocarían y posiblemente se
produciría un cortocircuito que haría que circulase poca energía a
través del tejido 150, dando así por resultado un mal sellado 152
del tejido. Una fuerza demasiado pequeña haría que el sellado 152
fuese demasiado grueso.
La aplicación de la fuerza correcta es también
importante por otras razones: para oponer las paredes del vaso;
para reducir la impedancia del tejido a un valor lo suficientemente
bajo que permita que pase suficiente corriente a través del tejido
150; y para superar las fuerzas de dilatación durante el
calentamiento del tejido, además de contribuir a la creación del
grosor final requerido del tejido, lo que es una indicación de un
buen sellado 150.
Como se ha mencionado en lo que antecede, al
menos un miembro de mordaza, por ejemplo, el 120, puede incluir un
miembro de tope 140 asociado operativamente con el mismo, que limite
el movimiento de los dos miembros de mordaza opuestos 110 y 120
cada uno con relación al otro. Por ejemplo, el miembro de tope 140
puede extenderse desde la superficie de sellado 134 en una
distancia predeterminada de acuerdo con las propiedades específicas
del material (por ejemplo, la resistencia a la compresión, la
dilatación térmica, etc.) para obtener una distancia de separación
"G" consistente y precisa durante el sellado (Fig. 6A). La
distancia de separación entre las superficies de sellado opuestas
112 y 114 durante el sellado varía desde aproximadamente 0,0254 mm
hasta aproximadamente 0,1524 mm y, más preferiblemente, desde
aproximadamente 0,0508 mm hasta aproximadamente 0,1016 mm.
Como alternativa, los miembros de tope no
conductores 140 pueden ser moldeados sobre los miembros de mordaza
110 y 120 (por ejemplo, por sobremoldeo, por moldeo por inyección,
etc.), estampados sobre los miembros de mordaza 110 y 120, o
depositados (por ejemplo, por deposición) sobre los miembros de
mordaza 110 y 120. Por ejemplo, una técnica comporta rociar
térmicamente un material cerámico o de porcelana sobre la superficie
del miembro de mordaza 110 y 120 para formar los miembros de tope
149. Están contempladas varias técnicas de rociado térmico, que
comportan depositar un amplio margen de materiales resistentes al
calor y aislantes sobre varias superficies, para crear miembros de
tope para controlar la distancia de separación entre las superficies
conductoras eléctricas 112 y 134.
Puesto que la energía se trasfiere
selectivamente al conjunto ejecutor final 100 a través de los
miembros de mordaza 110 y 120 y a través del tejido 150, se forma
un sello 152 en el tejido aislando dos mitades del tejido 150a y
150b. En este punto, y con otros instrumentos de sellado de vasos
conocidos, el usuario debe retirar y reemplazar los fórceps 10 por
un instrumento de corte (no representado), para dividir las mitades
del tejido 150a y 150b a lo largo de una línea central aproximada
B-B del sello 152 del tejido. Como puede
apreciarse, esto a la vez que lleva tiempo es tedioso y puede dar
por resultado una división inexacta del tejido a través del sello
152 del tejido, debido a la desalineación o a una colocación
defectuosa del instrumento de corte a lo largo del plano de corte
ideal del tejido, por ejemplo, de la línea central
B-B.
Una vez formado el sello 152 en el tejido, se
pueden abrir los miembros de mordaza 110 y 120 asiendo para ello de
nuevo el mango 40. Una vez abiertos los miembros de mordaza, se
mueve el electrodo giratorio 122 llevándolo a su segunda posición
operable por medio del conjunto giratorio 80, donde el borde de
corte 130 es en general perpendicular a la superficie de sellado
112. Una vez situado el electrodo 122, se vuelve a asir el mango 40
cerrando los miembros de mordaza 110 y 120 y llevando el borde de
corte 130 a estrecha proximidad con la superficie de sellado 112
para dividir el tejido 150 a lo largo por el punto 154. El tejido
puede ser cortado utilizando una acción de corte mecánica, una
acción de corte electromecánica, o simplemente una acción de corte
eléctrica, dependiendo de la finalidad particular que se persiga y
dependiendo de la configuración particular del borde de corte
130.
Puede apreciarse que dado que los fórceps 10
pueden sellar y dividir el tejido sin retirar los fórceps 10 de la
zona de la operación, se puede llevar a cabo más rápidamente el
procedimiento previsto. Además, el sello 152 será dividido
uniformemente, ya que el usuario no tendrá que situar el centro del
sello después de insertar un instrumento diferente, por ejemplo, un
instrumento de corte.
De lo expuesto en lo que antecede, y con
referencia a los diversos dibujos de las figuras, quienes sean
expertos en la técnica apreciarán que también se pueden efectuar
ciertas modificaciones en la presente exposición sin rebasar el
alcance de la misma. Por ejemplo, los fórceps 10 (y/o el generador
electroquirúrgico usado en relación con los fórceps 10) pueden
incluir un sensor o mecanismo de realimentación (no representado)
que seleccione automáticamente la cantidad apropiada de energía
electroquirúrgica para sellar efectivamente el tejido de las
dimensiones particulares cogido entre los miembros de mordaza 110 y
120, y seleccionar subsiguientemente la energía apropiada para
cortar el tejido selectivamente. El sensor o mecanismo de
realimentación puede también medir la impedancia a través del
tejido durante el sellado, y proporcionar un indicador (visual y/o
audible) de que se ha creado un sello efectivo entre los miembros
de mordaza 110 y 120. Ejemplos de tales sistemas de sensor se han
descrito en la Patente de EE.UU. cedida en común Nº 7.137.980
titulada "METHOD AND SYSTEM FOR CONTROLLING OUTPUT OF RF MEDICAL
GENERATOR" (Método y Sistema para Controlar la Salida del
Generador de RF Médico), concedida con fecha 21 de noviembre de
2006.
Está contemplado que la superficie exterior del
conjunto ejecutor final 100 pueda incluir un material a base de
níquel, de recubrimiento por estampación, por moldeo por inyección
metálica, que está diseñado para reducir la adherencia entre los
miembros de mordaza 110 y 120 con el tejido circundante durante la
activación y el sellado. Además, está también contemplado que las
superficies conductoras 112 y 134 de los miembros de mordaza 110 y
120 pueden ser fabricadas de uno (o de una combinación de uno o más)
de los siguientes materiales: cromo-níquel, nitruro
de cromo, MedCoat 2000 fabricado por The Electrolizing Corporation
de OHIO (EE.UU.), Inconel 600 y aleación de
estaño-níquel. Las superficies conductoras del
tejido 112 y 134 pueden también ser recubiertas con uno o más de
los anteriores materiales para conseguir el mismo resultado, es
decir, una "superficie no adherente". Como puede apreciarse,
reduciendo la intensidad con que se "adhiere" el tejido durante
el sellado y el corte, se mejora la eficacia total del
instrumento.
Una clase particular de materiales aquí
descritos ha mostrado propiedades de no adherencia superiores y, en
algunos casos, una calidad de sellado superior. Por ejemplo, los
recubrimientos de nitruro que incluyen, aunque no quedan limitados
a: TiN, ZrN, TiAIN, y CrN, son materiales preferidos usados para
fines de no adherencia. El CrN se ha visto que es particularmente
útil para fines de no adherencia debido a sus propiedades generales
de superficie y a sus óptimas actuaciones. También se ha comprobado
que otras clases de materiales reducen la adherencia en general.
Por ejemplo, las aleaciones con alto contenido de níquel/cromo, con
una relación de Ni/Cr de aproximadamente 5:1, se ha visto que
reducen significativamente la adherencia en los instrumentos
bipolares. Un material no adherente particularmente útil de esta
clase es el Inconel 600. Los instrumentos bipolares que tienen
superficies de sellado 112 y 134 hechas de, o recubiertas con,
Ni200, Ni201 (-100% Ni), también han mostrado mejores actuaciones
en cuanto a no adherencia sobre los electrodos de acero inoxidable
bipolares típicos.
Como puede apreciarse, la colocación del
conmutador 200 en los fórceps 10 tiene muchas ventajas. Por ejemplo,
el conmutador 200 reduce la cantidad de cable eléctrico en la sala
de operaciones, y elimina la posibilidad de que se active el
instrumento equivocado durante un procedimiento quirúrgico, debido a
la activación en la "línea de mira". También está contemplado
que el conmutador 200 pueda ser dispuesto en otra parte de los
fórceps 10, por ejemplo, en el mango 150, en el conjunto giratorio
80, en el alojamiento 20, etc.
Está también contemplado que los fórceps puedan
ser dimensionados para incluir un espacio de separación fijo dentro
del margen de aproximadamente 0,0254 mm hasta aproximadamente 0,1524
mm, proporcionando para ello un miembro de tope en otra parte del
conjunto ejecutor final, por ejemplo, proximal y/o distal a las
superficies conductoras, en el alojamiento aislante 110 y/o 126,
y/o como parte del pivote 103. Está además contemplado que la
disposición de fiador 117 y abertura 62 pueda ser dimensionada para
limitar la distancia entre las superficies conductoras 112 y
122.
Aunque en los dibujos se han representado varias
realizaciones de la exposición, no se pretende que esta exposición
quede limitada a ellas, ya que lo que se pretende es que la
exposición sea entendida en cuanto a su alcance con tanta amplitud
como permita la técnica, y que así sea igualmente leída la memoria
descriptiva. Por lo tanto, la anterior descripción no deberá ser
entendida como limitadora, sino simplemente como ejemplos de
realizaciones preferidas. Quienes sean expertos en la técnica
contemplarán otras modificaciones, dentro del alcance de las
reivindicaciones que aquí se acompañan.
Claims (9)
1. Un instrumento electroquirúrgico (10) para
sellar y dividir tejido, que comprende:
un alojamiento (20) que tiene un eje (12) unido
al mismo, definiendo el eje (12) un eje geométrico longitudinal
(A);
miembros de mordaza opuestos primero (110) y
segundo (120), acoplados al eje (12), teniendo el primer miembro de
mordaza (110) una superficie conductora (112) y siendo movible con
relación al segundo miembro de mordaza (120), y estando el segundo
miembro de mordaza (120) fijo con relación al eje (12), e incluyendo
un electrodo (122) giratorio alrededor del eje geométrico
longitudinal (A),
incluyendo el electrodo giratorio (122) una
primera superficie (134) para sellar tejido, y una segunda
superficie (130) para cortar tejido;
adaptado cada miembro de mordaza para ser
conectado a una fuente (310) de energía electroquirúrgica, tal que
los miembros de mordaza sean capaces de conducir selectivamente
energía a través del tejido (150) sujeto entre ellos; y
al menos un miembro de tope no conductor (140)
dispuesto en al menos uno de los miembros de mordaza primero (110)
y segundo (120), que controla la distancia de separación entre los
miembros de mordaza cuando está sujeto el tejido (150) entre
ellos.
2. Un instrumento electroquirúrgico (10) de
acuerdo con la reivindicación 1, que comprende además un conjunto
giratorio (80) que hace girar al electrodo (122) del segundo miembro
de mordaza (120), asociado el conjunto giratorio (80)
operativamente con el alojamiento (20) y accionable para establecer
la orientación del electrodo (122) entre una primera posición
operable para sellar tejido, y una segunda posición operable para
cortar tejido.
3. Un instrumento electroquirúrgico (10) de
acuerdo con la reivindicación 2, en el que cuando el electrodo
(122) está dispuesto en la primera posición operable, una superficie
de sellado (134) del electrodo (122) es en general paralela a la
superficie conductora (112) del primer miembro de mordaza (110) para
hacer posible el sellado del tejido al tener lugar la
activación.
4. Un instrumento electroquirúrgico (10) de
acuerdo con la reivindicación 2 ó 3, en el que cuando el electrodo
(122) está dispuesto en la segunda posición operable, un borde de
corte (130) del electrodo (122) es perpendicular a la superficie
conductora (112) del primer miembro de mordaza (110), para hacer
posible el corte del tejido.
5. Un instrumento electroquirúrgico (10) de
acuerdo con la reivindicación 4, construido y dispuesto de tal modo
que, en uso, la energía electroquirúrgica es conducida
selectivamente entre el borde de corte (130) del electrodo (122) y
la superficie conductora (112) del primer miembro de mordaza (110)
para hacer posible el corte del tejido.
6. Un instrumento electroquirúrgico (10) de
acuerdo con una cualquiera de las reivindicaciones precedentes, en
el que los miembros de tope (140) controlan la distancia entre las
superficies conductoras eléctricas en un margen desde
aproximadamente 0,0254 mm hasta aproximadamente 0,1524 mm.
7. Un instrumento electroquirúrgico de acuerdo
con la reivindicación 6, en el que los miembros de tope controlan
la distancia entre las superficies conductoras eléctricas desde
aproximadamente 0,0508 mm hasta aproximadamente 0,1016 mm.
8. Un instrumento electroquirúrgico (10) de
acuerdo con una cualquiera de las reivindicaciones precedentes, en
el que el al menos un miembro de tope no conductor (140) está
dispuesto en la superficie de sellado (134) del electrodo
giratorio.
9. Un instrumento electroquirúrgico (10) de
acuerdo con una cualquiera de las reivindicaciones precedentes, que
comprende además un conjunto de mango (30) que mantiene una presión
de cierre de sellado de tejido en un margen desde aproximadamente 3
kg/cm^{2} entre los miembros de mordaza primero (110) y segundo
(120).
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ES2317347T3 true ES2317347T3 (es) | 2009-04-16 |
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ES06000707T Active ES2317347T3 (es) | 2005-01-14 | 2006-01-13 | Dispositivo sellador y divisor de tejido con dispositivo sellador y de corte rotatorio. |
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EP (1) | EP1681027B1 (es) |
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US7686804B2 (en) | 2010-03-30 |
EP1681027B1 (en) | 2008-12-31 |
EP1681027A1 (en) | 2006-07-19 |
AU2006200138A1 (en) | 2006-08-03 |
US7951150B2 (en) | 2011-05-31 |
US20060167450A1 (en) | 2006-07-27 |
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AU2006200138B2 (en) | 2011-05-12 |
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