ES2348273T3 - Dispositivo de grapado quirurgico. - Google Patents
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- ES2348273T3 ES2348273T3 ES08003414T ES08003414T ES2348273T3 ES 2348273 T3 ES2348273 T3 ES 2348273T3 ES 08003414 T ES08003414 T ES 08003414T ES 08003414 T ES08003414 T ES 08003414T ES 2348273 T3 ES2348273 T3 ES 2348273T3
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- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
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- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
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- A—HUMAN NECESSITIES
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- A61B2017/07214—Stapler heads
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- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
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- A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
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Abstract
Dispositivo de grapado quirúrgico (10), que comprende: un conjunto de mango; una parte de cuerpo endoscópica (18) y un conjunto de herramientas (12) que está montado para la articulación con respecto a la parte de cuerpo endoscópica (18), que incluye: un yunque (14); un conjunto de cartucho de grapas (16) que incluye un cartucho (16a) provisto de una pluralidad de grapas quirúrgicas; y un elemento de sujeción dinámico (32) provisto de un rebaje (68), estando provisto el elemento de sujeción dinámico de un reborde superior (36a) para el acoplamiento del yunque y de un reborde inferior (36b) para el acoplamiento del conjunto de cartucho (16), siendo el yunque (14) y el conjunto de cartucho (16) móviles uno con relación al otro entre posiciones separadas y aproximadas, siendo el elemento de sujeción dinámico (32) móvil para expulsar las grapas desde el cartucho (16a) y para mantener un espacio máximo del tejido entre el yunque (14) y el conjunto de cartucho (16); y caracterizado porque: el dispositivo comprende además un elemento flexible (62) unido al elemento de sujeción dinámico (32) y móvil de forma distal para hacer avanzar el elemento de sujeción dinámico (32) de forma distal a través del cartucho de grapas (16a), estando conformado un extremo distal del elemento flexible (62) para adaptarse al rebaje (68), de tal modo que el extremo distal del elemento flexible (62) pueda ser recibido por el rebaje (68).
Description
Dispositivo de grapado quirúrgico.
La presente solicitud reivindica la prioridad de
la solicitud provisional US nº de serie 60/416,088, presentada el 4
de octubre de 2002.
La presente exposición se refiere a un conjunto
de herramientas para tratar tejidos. Más particularmente, la
presente revelación se refiere a un conjunto de herramientas
quirúrgicas endoscópicas capaces de articular y girar para el
tratamiento de tejidos.
Las engrapadoras quirúrgicas para sujetar un
tejido entre estructuras de mordazas opuestas de un conjunto de
herramientas y después de ello fijar el tejido sujeto son muy
conocidas en la técnica. Estos dispositivos pueden incluir un
bisturí para realizar una incisión en el tejido fijado. Las
engrapadoras de este tipo provistas de configuraciones
laparoscópicas o endoscópicas son también muy conocidas en la
técnica. Ejemplos de estas engrapadoras quirúrgicas endoscópicas se
describen en las patentes US nº 6.330.965; nº 6.250.532; nº
6.241.139; nº 6.109.500 y nº 6.079.606.
Típicamente, estas engrapadoras incluyen un
elemento de herramienta provisto de un cartucho de grapas para el
alojamiento de una pluralidad de grapas dispuestas en por lo menos
dos filas lateralmente separadas y un yunque el cual incluye una
pluralidad de bolsas para la formación de la grapa para recibir y
conformar las patas de las grapas cuando las grapas son dirigidas
desde el cartucho. El yunque, típicamente, está sostenido de forma
articulada de manera adyacente al cartucho y puede articular entre
posiciones abierta y cerrada.
Durante los procedimientos quirúrgicos
laparoscópicos o endoscópicos, el acceso al lugar quirúrgico se
consigue a través una pequeña incisión o a través de una cánula
estrecha insertada a través de una pequeña herida de entrada en un
paciente. Debido a la limitada área para acceder al lugar
quirúrgico, muchas engrapadoras endoscópicas incluyen mecanismos
para girar la parte de cuerpo endoscópica del dispositivo o para la
articulación del conjunto de herramientas del dispositivo.
Típicamente, cada mecanismo está controlado por un accionamiento el
cual tiene que ser manipulado por un cirujano para orientar
apropiadamente el conjunto de herramientas con relación al tejido
que se va a tratar. Las manipulaciones de este tipo consumen tiempo
y pueden no resultar en la orientación exacta del conjunto
herramientas deseada por el cirujano.
Por consiguiente, existe la necesidad de un
dispositivo de grapado quirúrgico endoscópico que incluya un
mecanismo para el ajuste de la orientación de un conjunto de
herramientas el cual es fácil de accionar y pueda colocar un
conjunto de herramientas en cualquier orientación deseada.
La patente US nº 5.797.537 revela un instrumento
quirúrgico articulado para utilizarlo en procedimientos quirúrgicos
laparoscópicos. El instrumento incluye un elemento de accionamiento
de compresión flexible el cual está dispuesto de forma deslizante en
el árbol y se extiende a través del espacio que se extiende
longitudinalmente entre el árbol y la punta del instrumento.
Según la presente invención, se da a conocer un
instrumento quirúrgico que incluye un conjunto de herramientas
provisto de un par de mordazas. El conjunto de herramientas incluye
un yunque y un conjunto de cartucho del cual tiene una pluralidad de
elementos de fijación sostenidos en su interior. El conjunto de
cartucho es móvil con relación al yunque entre una posición separada
y una posición aproximada. Un elemento de sujeción es móvil desde
una posición retraída hasta una posición avanzada para desplazar el
conjunto de cartucho con relación al yunque desde la posición
separada hasta la posición aproximada. Un elemento de sujeción
dinámico está colocado de forma móvil con relación al yunque y al
conjunto de cartucho desde una posición retraída hasta una avanzada
para expulsar la pluralidad de elementos de fijación desde el
conjunto de cartucho. Un elemento de accionamiento formado a partir
de un cable flexible está funcionalmente conectado al elemento de
sujeción y al elemento de sujeción dinámico y es móvil para
desplazar el elemento de sujeción y el elemento de sujeción dinámico
entre sus posiciones retraídas y avanzadas.
Preferentemente, el elemento de accionamiento
incluye un cable coaxial que incluye una fundada exterior y una
varilla central. La varilla central es axialmente móvil y puede
girar con relación a la funda exterior. La funda exterior está
funcionalmente conectada al elemento de sujeción y la varilla
central está funcionalmente conectada al elemento de cierre.
Preferentemente, un collar está sujeto
articuladamente a una parte del cuerpo de un dispositivo de grapado.
La parte del cuerpo puede formar el extremo distal de un dispositivo
de grapado quirúrgico o el extremo proximal de un conjunto de carga
desechable.
Preferentemente, el conjunto de herramientas
está montado de forma giratoria en el elemento de collar. En una
forma de realización preferida, la varilla central del cable coaxial
está conectada al dispositivo de sujeción dinámico, de tal modo que
el giro de la varilla central efectúe el giro del elemento de cierre
para efectuar el giro del conjunto de herramientas con relación al
elemento de collar para facilitar el giro independiente del conjunto
de herramientas.
En una forma de realización preferida, el
elemento de sujeción dinámico incluye una primera parte de reborde
colocada para acoplar una superficie del yunque y una segunda parte
de reborde colocada para acoplar una superficie del conjunto de
cartucho. La primera y segunda partes de reborde juntas definen un
espacio máximo del tejido entre el yunque y el conjunto de
cartucho.
Diversas formas de realización del dispositivo
de grapado quirúrgico actualmente dado a conocer se describen a
continuación en la presente memoria haciendo referencia a los
dibujos, en los que:
la figura 1 es una vista lateral en perspectiva
de una forma de realización preferida del dispositivo de grapado
quirúrgico actualmente dado a conocer con el yunque y el conjunto de
cartucho en la posición separada;
la figura 1A es una vista lateral en perspectiva
del extremo proximal del yunque, el collar de giro y el adaptador
del dispositivo de grapado quirúrgico representado en la figura
1;
la figura 2 es una vista lateral del dispositivo
de grapado quirúrgico representado en la figura 1;
la figura 3 es una vista desde arriba con los
componentes interiores en líneas discontinuas del dispositivo de
grapado quirúrgico representado en la figura 2;
la figura 4 es una vista en sección transversal
del dispositivo de grapado quirúrgico representado en la figura 2
tomada a lo largo de un eje longitudinal del dispositivo a través
del conjunto de cartucho;
la figura 5 es una vista en sección transversal
del dispositivo de grapado quirúrgico representado en la figura 3
tomada a lo largo de un eje transversal a través del elemento de
sujeción dinámico con el elemento de herramienta aproximado;
la figura 6 es una vista en sección transversal
del dispositivo de grapado quirúrgico representado en la figura 3
tomada a lo largo de un eje transversal del conjunto de herramientas
a través del conjunto de cartucho y el yunque;
la figura 7 es una vista superior en perspectiva
del elemento de sujeción dinámico del dispositivo de grapado
quirúrgico representado en la figura 1;
la figura 8 es una vista superior en perspectiva
del elemento de sujeción del dispositivo de grapado quirúrgico
representado en la figura 1;
la figura 9 es una vista superior en perspectiva
del collar de accionamiento del dispositivo de grapado quirúrgico
representado en la figura 1;
la figura 10 es una vista lateral en perspectiva
del despiece del conjunto de herramientas del dispositivo de grapado
quirúrgico representado en la figura 1;
la figura 11 es una vista a mayor escala del
extremo proximal del conjunto de herramientas representado en la
figura 10;
la figura 12 es una vista lateral en perspectiva
del despiece de la parte de cuerpo endoscópica del dispositivo de
grapado quirúrgico representado en la figura 1;
la figura 13 es una vista lateral en sección
transversal del dispositivo de grapado quirúrgico representado en la
figura 1;
la figura 14 es otra forma de realización del
elemento de cierre según la presente revelación;
la figura 15 es una vista en planta superior del
alojamiento del cartucho de la presente revelación;
las figuras 16A y 16B son unas vistas en
perspectiva de los elementos de corredera e impulsor de la presente
revelación;
la figura 17A es una vista extrema en sección
transversal de una parte del conjunto de cartucho de la figura 16B,
tomada a lo largo de las líneas 17A, ilustrando la disposición de la
corredera, el elemento impulsor y la grapa según una forma de
realización de la presente exposición; y
la figura 17B es una vista extrema en sección
transversal de una parte del conjunto de cartucho ilustrando la
disposición de la corredera, el elemento impulsor y la grapa según
otra forma de realización de la presente exposición.
Las formas de realización preferidas del
dispositivo de grapado quirúrgico actualmente revelado se
describirán a continuación en detalle haciendo referencia a los
dibujos en los cuales números de referencia iguales designan
elementos idénticos o correspondientes en cada una de las diversas
vistas.
Las figuras 1-13 ilustran una
forma de realización preferida del dispositivo de grapado quirúrgico
actualmente revelado mostrado globalmente como 10. El dispositivo de
grapado 10 incluye un conjunto de herramientas 12 provisto de un
yunque 14 y un conjunto de cartucho 16, una parte de cuerpo
endoscópica 18, un elemento de sujeción 20 y un collar de giro 22.
El conjunto de herramientas 12 está articuladamente sostenido en el
extremo distal de la parte de cuerpo endoscópica 18 alrededor de un
elemento de articulación 24. Un adaptador 26 está unido al extremo
distal de la parte del cuerpo 18 e incluye extensiones superior e
inferior 28. Un separador 18a (figura 12) puede estar colocado en el
interior del cuerpo anterior 8 para mantener la colocación de los
componentes internos del dispositivo. Alternativamente, un adaptador
26 puede estar formado monolíticamente con la parte de cuerpo
endoscópica 18. El elemento de articulación 24 se extiende entre
extensiones superior e inferior 28 y una parte proximal 22a (figura
1A) del collar de giro 22 de tal forma que el conjunto de
herramientas 12 puede articular con relación al eje longitudinal de
la parte endoscópica 18 aproximadamente 90º. Se contempla que puedan
estar provistas una variedad de tipos de juntas de articulación
diferentes, por ejemplo de bola y casquillo adaptador, un
acoplamiento flexible, una junta universal, etc., para permitir
mayores grados de articulación.
El conjunto de cartucho 16 incluye un cartucho
16a que aloja una pluralidad de grapas (no representadas), una parte
de canal 30 que define un rebaje para recibir el cartucho 16a, un
elemento de sujeción dinámico 32 (figura 7) y una corredera 31. El
elemento de sujeción dinámico 32 preferentemente está colocado de
manera proximal a la corredera 31 en el interior del cartucho 16a.
Una cuchilla de bisturí 34 está preferentemente colocada en una
parte del cuerpo intermedia, preferentemente central, 32a del
elemento de sujeción dinámico 32 para la incisión del tejido fijado.
La cuchilla del bisturí 34 puede estar mecanizada directamente en el
elemento de sujeción dinámico o puede estar sujeta al mismo de forma
fija o de forma que se pueda extraer. Alternativamente, la cuchilla
del bisturí 34 puede estar formada o sujeta de forma fija, de forma
que se puede extraer o articuladamente en la corredera. La corredera
31 está colocada de forma deslizante para trasladarse a través del
cartucho 16a para expulsar las grapas del cartucho de una manera
conocida. El elemento de sujeción dinámico 32 incluye rebordes
superior e inferior 36a y 36b. Como se representa en la figura 5, el
reborde 36a está colocado en el interior de una muesca o rebaje 38
formado en el cartucho 16a y el reborde 36b está colocado en el
interior de un rebaje 40 formado en el yunque 14. Alternativamente,
los rebordes 36a y 36b no tienen que estar colocados de forma
deslizante en rebajes sino que únicamente necesitan acoplar una
superficie de apoyo superior en el yunque 14 y una superficie de
apoyo inferior en el conjunto de cartucho 16. Tal como se ilustra en
la figura 7, los rebordes 36a y 36b preferentemente son arqueados o
semicirculares para hacer mínima la flexión y mantener la alineación
del yunque o del cartucho durante la actuación de la engrapadora. El
elemento de sujeción dinámico 32 está colocado de manera proximal a
la corredera en acoplamiento con la misma y se puede trasladar a
través del cartucho. Un elemento de cierre 32 provee, restablece o
mantiene un espacio deseado en el tejido, preferentemente uniforme,
en el área del conjunto de herramientas 12 adyacente a la corredera
31 durante el disparo del dispositivo 10. El movimiento del elemento
de sujeción dinámico 32 a través del conjunto de cartucho 16 avanza
la corredera a través del conjunto de cartucho.
Se contempla que el yunque o el elemento de
sujeción dinámico, preferentemente ambos, este formado de un
material y sea de un espesor o anchura de tal tipo que haga mínima
la flexión del respectivo yunque o elemento de sujeción dinámico
durante la sujeción, traslación a través y disparo del dispositivo.
Los materiales de este tipo incluyen acero inoxidable de grado
quirúrgico. Preferentemente, el yunque está formado como un conjunto
de una pieza maciza. Alternativamente, como es conocido en la
técnica, el yunque puede estar formado por un conjunto de piezas que
incluyen un cuerpo del yunque y una placa del yunque provista de una
pluralidad de bolsas para la formación de grapas. Se desea que el
yunque sea tan resistente como sea razonablemente posible y
necesario para minimizar la distorsión, por ejemplo, que el extremo
distal del yunque se arquee hacia arriba durante la sujeción o la
sujeción previa o durante el disparo de la grapa.
Haciendo referencia a la figura 1A, el extremo
proximal de yunque 14 incluye una parte cilíndrica 14a provistas de
un rebaje angular 14b. La parte cilíndrica 14a está dimensionada
para ser recibida en el interior de un taladro 22a del collar 22.
Por lo menos un pasador de articulación 23 (figura 1) se extiende a
través del collar 22 en el interior de un rebaje 14b para fijar
axialmente el extremo proximal del yunque 14 en el interior del
taladro 22a. Puesto que el pasador 23 está colocado en el interior
de un rebaje anular 14b, el yunque 14 puede girar en el interior del
collar 22. Se contempla que puedan estar provistos otros medios para
unir de forma giratoria el yunque 14 al collar 22. Un segundo
pasador 22 (figura 1) se extiende a través del collar 22 para
sujetar el collar 22 a un extremo distante del enlace de
articulación 52 como se describirá a continuación en la presente
memoria.
Aunque no está representado, de una manera
conocida, el extremo proximal de la parte de canal 30 del conjunto
de cartucho 16 incluye un rebaje para recibir un elemento de
articulación, por ejemplo, una lengüeta o pasador, formado o unido
al extremo proximal de yunque 14. Los extremos proximales del yunque
14 y el cartucho 16 están encajados en el interior del collar 22
para evitar que el elemento de articulación del yunque se desacople
del rebaje en la parte de canal 30 del conjunto de cartucho 16.
Alternativamente, se pueden utilizar otras disposiciones mecánicas
conocidas en la técnica para sujetar articuladamente el yunque 14 al
conjunto de cartucho 16. Se observa que puesto que el conjunto de
cartucho 16 está unido de forma articulada al yunque 14, ambos
pueden girar con respecto al collar 22.
Haciendo referencia a las figuras 1 y 4, está
provisto un mecanismo de articulación para articular el conjunto de
herramientas 12 con relación a la parte de cuerpo endoscópica 18. El
mecanismo de articulación incluye un enlace de articulación proximal
50 y un enlace de articulación distal 52. El enlace de articulación
proximal 50 tiene un primer extremo 50a que se extiende desde el
extremo proximal de la parte de cuerpo endoscópica 18 y un segundo
extremo 50b colocado en el interior de la parte de cuerpo 18 y
articuladamente conectado a un primer extremo 52a del segundo enlace
de articulación 52. Un segundo extremo 52b del enlace de
articulación 52 está articuladamente conectado al collar de giro 22
mediante un pasador 25 (figura 1) en un punto de desplazamiento
desde el elemento de articulación 24, esto es el eje de articulación
del conjunto de herramientas 12. El enlace de articulación 52 está
encajado en una muesca 54 formada en la parte de cuerpo endoscópica
18. Debido a la restricción, el mecanismo de articulación es
únicamente capaz de la articulación del conjunto de herramientas 12
sobre un arco en un lado del eje longitudinal del dispositivo.
Preferentemente, cada una de las conexiones articuladas
identificadas anteriormente en la presente memoria incluye un
pasador de articulación. Alternativamente, los elementos
articulación pueden estar formados integralmente con los componentes
anteriores o se pueden utilizar elementos de articulación que no
incluyan pasadores. También
se contemplan otros tipos de enlaces de articulación.
se contemplan otros tipos de enlaces de articulación.
En utilización, cuando el eje longitudinal del
conjunto de herramientas 12 está alineado con el eje longitudinal de
la parte del cuerpo 18 y el enlace de articulación proximal 50 se
retrae en la dirección indicada mediante la flecha "A" en la
figura 4, el enlace 50 retrae el enlace 52 para efectuar la
articulación del conjunto de herramientas 12 alrededor del elemento
de articulación 24 en la dirección indicada mediante la flecha
"B" en la figura 4. El conjunto de herramientas 12 puede ser
devuelto a una posición no articulada avanzando el enlace 50 en la
dirección indicada mediante la flecha "C". El mecanismo para
controlar el movimiento del mecanismo de articulación se describirá
más adelante en la presente memoria.
Haciendo referencia a las figuras
3-9, está provisto un mecanismo de accionamiento
para la aproximación del yunque 14 y el conjunto de cartucho 16,
disparar las grapas y girar el conjunto de herramientas 12 con
relación al collar 22. El mecanismo de accionamiento incluye un
cable coaxial o elemento de accionamiento 60 (figura 3) provisto de
una varilla central 62, una funda exterior 64, un collar de
accionamiento 66 (figura 9), un elemento de sujeción, aquí
representado como un anillo de sujeción 20 y un elemento de sujeción
dinámico 32. La varilla central 62 es o incluye un elemento flexible
provisto de una resistencia a la compresión adecuada para empujar al
elemento de sujeción dinámico 32 a través del cartucho 16a.
Preferentemente, la varilla central 62 incluye un cable flexible
enrollado hacia el lado izquierdo o el derecho. Alternativamente,
también se pueden utilizar otros materiales que tengan
características de resistencia adecuadas, por ejemplo,
Nitinol^{TM}. El diámetro de la varilla central 62 debe ser lo
suficientemente pequeño como para ser colocado en el interior del
espacio disponible dentro del cartucho 16a. La funda exterior 64
está colocada alrededor de la varilla central 62 y en parte funciona
para estabilizar y prevenir el pandeo de la varilla central 62
mientras está comprimida. Preferentemente, la funda exterior 64
también es un cable flexible formado a partir de una malla de acero,
plástico reforzado o una aleación de titanio de níquel tal como, por
ejemplo, Nitinol^{TM}. También se contempla que para formar la
funda exterior también se puedan utilizar otros materiales adecuados
que tengan los requisitos de resistencia requeridos incluyendo un
material parafenilenotereftalamida tal como Kevlar^{TM},
comercialmente disponible por DuPont.
La varilla central 62 está colocada de forma
deslizante en el interior de la funda exterior 64 e incluye un
primer extremo proximal 62a (figura 4) que se extiende
preferentemente desde el extremo proximal de la parte de cuerpo
endoscópica 18 y un segundo extremo 62b unido al elemento de
sujeción dinámico 32. El elemento de sujeción dinámico 32
preferentemente incluye un rebaje 68 (figura 7) formada en su
interior para recibir un segundo extremo 62b de la varilla central
62. El segundo extremo 62b puede estar sujeto al elemento de
sujeción dinámico 32 mediante engarzado, soldadura como en la figura
4, soldadura fuerte, pasadores, etc., en el interior o utilizando,
por ejemplo, el rebaje 68 y también puede estar mecanizado para
adaptarse a la forma del rebaje 68.
La funda exterior 64 tiene un primer extremo
proximal 64a que se extiende preferentemente desde el extremo
proximal de la parte del cuerpo alargada 18 y un segundo extremo
distal 64b fijamente conectado al collar de accionamiento 66. El
collar de accionamiento 66 (figura 9) preferentemente incluye un
taladro central 70 para recibir la funda exterior 64 y proporcionar
un canal para el paso de la varilla central 62 a través del mismo.
La superficie exterior del collar de accionamiento 66
preferentemente incluye una estructura de acoplamiento, por ejemplo
entalladuras 72, para el acoplamiento del elemento de sujeción o
anillo 20 en una relación giratoriamente fijo. El anillo de sujeción
20 también incluye una estructura de acoplamiento, por ejemplo,
vetas o prolongaciones 74, para acoplarse con la estructura de
acoplamiento del collar de accionamiento 66 para fijar
giratoriamente el collar de accionamiento 66 al anillo de sujeción
20 de modo que puedan girar juntos. El extremo distal 20a del anillo
de sujeción 20 incluye un par de muescas 76 configuradas para
recibir y acoplar las partes de reborde 36a y 36b del elemento de
sujeción dinámico 32.
En utilización, la varilla central 62 y la funda
exterior 64 son móviles juntas desde una posición retraída hasta una
posición parcialmente avanzada para avanzar el collar de
accionamiento 66, el anillo de sujeción 20 y el elemento sujeción
dinámico 32 hasta una primera posición avanzada. El anillo de
sujeción 20, preferentemente, está colocado alrededor del extremo
proximal del yunque 14 y el conjunto de cartucho 16. El conjunto de
cartucho 16 incluye una superficie de leva 80 (figura 2) formada en
una superficie exterior del mismo. Cuando el elemento de sujeción
dinámico 32 se desplaza desde la posición retraída hasta la primera
posición avanzada, el reborde 36b del elemento de sujeción dinámico
32 acopla la superficie de leva 80 del conjunto de cartucho 16 para
articular el conjunto de cartucho 16 desde la posición abierta hasta
la posición cerrada o sujeta. El anillo de sujeción 20 también es
desplazado de manera distal desde la primera posición avanzada hasta
una posición envolviendo las partes proximales del yunque 14 y del
conjunto de cartucho 16. En esta posición, el anillo de sujeción 20
evita que el espacio entre las partes proximales del yunque 14 y el
conjunto de cartucho y 16 exceda de una distancia previamente
determinada.
Después de que la varilla central 62 y la funda
exterior 64 hayan sido desplazadas hasta la primera posición
avanzada para desplazar el conjunto de cartucho 16 y, por
consiguiente, el yunque 14 a la posición sujetada, la varilla
central 62 puede ser avanzada independientemente de la funda
exterior 64 hasta una segunda posición avanzada para desplazar el
elemento de sujeción dinámico 32 a través del cartucho 16a para
expulsar las grapas desde el conjunto de cartucho y cortar el tejido
mediante la utilización de la cuchilla del bisturí 34 del elemento
de cierre 32. Se contempla que, alternativamente, los rebordes 36a y
36b del elemento de cierre 32 puedan acoplar una superficie de leva
en el yunque 14 o en el conjunto de cartucho 16 para articular uno o
ambos para proveer sujeción del tejido. Haciendo referencia a las
figuras 5 y 6, en el cartucho 16a se forma un canal 82 para proveer
soporte lateral a la varilla central 62 para evitar que la varilla
central 62 pandee durante el movimiento de la varilla central 62
desde la posición retraída hasta la segunda posición avanzada.
Tal como ha sido descrito anteriormente en la
presente memoria, el yunque 14 está sujeto de forma giratoria al
collar 22, la varilla central 62 está unida fijamente al elemento de
sujeción dinámico 32 y la funda exterior 64 esta unida fijamente al
collar de accionamiento 66. Cuando el elemento coaxial 60 es girado,
el conjunto de herramientas entero gira alrededor del eje central
del collar 22. Más específicamente, puesto que el elemento de
sujeción dinámico 32 está encajado en el interior del yunque 14 y el
conjunto de cartucho 16, cualquier momento de torsión aplicado a la
varilla central 62 es transferido a través del elemento de sujeción
dinámico 32 al conjunto de herramientas 12. De este modo, el
elemento coaxial 60 puede ser girado para girar el conjunto de
herramientas 12 alrededor del eje longitudinal del collar 22.
El conjunto de herramientas descrito
anteriormente en la presente memoria puede ser, se puede modificar,
o puede estar incorporado dentro de un conjunto de carga desechable
como se describe en la patente US nº 6.330.965 o unido directamente
al extremo distal de cualquier dispositivo de grapado quirúrgico
conocido. Aunque no hayan sido dados a conocer específicamente en la
presente memoria un conjunto de mango para el accionamiento del
elemento de articulación ni los mecanismos para la aproximación o
sujeción, disparo y giro de la herramienta, se comprenderá que se
contempla la utilización de una amplia variedad de mecanismos de
accionamiento diferentes y de configuraciones de mangos incluyendo
palancas acordadas, pomos giratorios y deslizantes, palancas
articuladas o disparadores, empuñaduras de pistola, mangos en línea,
sistemas remotamente accionados y cualquier combinación de los
mismos. Por ejemplo, tal como se representa en la figura 13A, el
conjunto de mango puede incluir un tipo de pistola 200 que incluye
un pomo de giro del conjunto de herramientas 210, una palanca de
articulación 212 y un pomo de giro del cuerpo 214. La utilización de
un conjunto de herramientas descrito antes en la presente memoria
como parte de un sistema robótico también se contempla.
Se contempla que la utilización de un material
de referencia más pesado para el conjunto de yunque sólo y
preferentemente también para el elemento de cierre y el anillo de
sujeción proporcione una presión de sujeción mejorada a lo largo de
la longitud del tejido el cual, a su vez, provee un espacio más
uniforme del tejido entre las respectivas superficies del yunque y
el cartucho adyacentes y por delante de las cuales se forman las
grapas a través del tejido. Además, utilizando el anillo de sujeción
para sujetar previamente el tejido, es decir, sujetar el tejido
antes de la deformación de las grapas, tiende a forzar algo del
fluido del tejido distalmente y radialmente hacia fuera lo cual
reduce la probabilidad de desplazar hidráulicamente las grapas
durante su deformación. La utilización de un elemento de cierre o
similar el cual sujeta a medida que se traslada a lo largo del
elemento de herramienta ayuda a compensar el flujo de fluido o desde
el interior del tejido o el arqueado hacia fuera del extremo distal
del yunque y, de ese modo, mantener el espacio deseado del tejido
entre el yunque y el conjunto de cartucho.
En otra forma de realización preferida como se
representa en la figura 14, el elemento de cierre 132 incluye
rebordes superior e inferior 136a, 136b separados y unidos a una
parte intermedia 132a. Al igual que en la forma de realización
anterior, el elemento de cierre 132 preferentemente está colocado de
manera proximal a la corredera 140 parcialmente en el interior de un
cartucho 118 el conjunto de cartucho 116. Una cuchilla de bisturí
134 está preferentemente colocada en la parte intermedia 132a del
elemento de cierre 132 para la incisión del tejido fijado. La
cuchilla de bisturí 134 puede estar mecanizada directamente en una
sección de la parte intermedia 132a o puede estar unida de forma
fija o de forma que se pueda desmontar a la parte intermedia 132a.
Alternativamente, la cuchilla del bisturí 134 puede estar formada
como parte de la corredera 140 o puede estar sujeta de forma fija o
de forma que se pueda desmontar a la corredera 140. Los rebordes
superior e inferior 136a, 136b son estructuras globalmente arqueadas
con curvaturas sustancialmente idénticas. Alternativamente, la
curvatura de los rebordes superior e inferior 136a, 136b puede ser
diferente para proveer mayor o menor soporte estructural. Cada
reborde 136a, 136b adicionalmente incluye una superficie interior
135a, 135b y una superficie exterior 137a, 137b. Preferentemente, el
elemento de cierre 132 está construido de tal modo que las
superficies interiores 135a, 135b están encaradas entre sí. Los
rebordes superior e inferior 136a, 136b funcionan para definir el
espacio máximo del tejido entre las superficies del yunque y
el
cartucho.
cartucho.
En una forma de realización preferida, el
conjunto de cartucho 116 incluye una pluralidad de muescas de
retención 122 dispuestas a lo largo de un eje longitudinal del
alojamiento del cartucho 118. Tal como se representa en la figura
15, las muescas de retención 122 están dispuestas para formar grupos
primero y segundo 124, 126. Preferentemente, cada grupo 124, 126
incluye tres filas de muescas de retención 122 configuradas de tal
modo que por lo menos una de las filas está desplazada
longitudinalmente de las filas restantes. Se prefiere además que por
lo menos dos filas de muescas de retención 122 estén dispuestas en
cada grupo 124, 126 del conjunto de cartucho 118 de tal modo que
cada muesca de retención 122 de una fila interior está en alineación
sustancialmente longitudinal con una muesca de retención
correspondiente 122 en la fila exterior y la fila intermedia de
muescas de retención 122 está longitudinalmente desplazada de las
filas interior y exterior. De ese modo, las filas interior y
exterior de muescas de retención 122 están longitudinalmente
alineadas desde la ubicación más proximal hasta la ubicación más
distal del alojamiento de cartucho 118. Preferentemente, una muesca
de retención 122 en las filas interior y exterior definen las
muescas de retención más proximal y más distal. La colocación
ventajosa de las muescas de retención 122 como ha sido descrita
mejora la fijación del tejido y hace mínimo el sangrado.
Haciendo referencia a las figuras
16A-17B, se ilustran formas de realización
adicionales de la corredera 140 y el elemento impulsor 150. El
elemento impulsor 150 incluye una parte de base 152. En la figura
16A, la corredera 140 ha sido avanzada longitudinalmente en el
alojamiento del cartucho 118 y empieza a acoplar la base 152 del
elemento impulsor 150. A medida que la corredera 140 es avanzada
adicionalmente en una dirección longitudinal (figura 16B), la base
152 del elemento impulsor 150 acopla las cuñas de leva levantadas
144 de la corredera 140. El movimiento longitudinal de la corredera
140 transfiere las fuerzas motrices longitudinales a lo largo de las
cuñas de leva 144 y, de ese modo, a los elementos impulsores 150.
Preferentemente, los elementos impulsores 150 están en una relación
fija con respecto al movimiento longitudinal de la corredera 140 y
se desplazan sustancialmente ortogonales al eje longitudinal del
conjunto de cartucho 118, transfiriendo de ese modo las fuerzas
motrices al tramo posterior 162 de la grapa 160 para el
desplazamiento de la grapa 160 a través de la muesca de retención
122. En una forma de realización preferida, como se ilustra en la
figura 17A, las cuñas de leva 144 de la corredera 140 acoplan un
rebaje 154 en el elemento impulsor 122. El rebaje 154 está
configurado y adaptado para el acoplamiento deslizante de la cuña de
leva 144. Una vez que la cuña de leva 144 acopla el rebaje 154, un
movimiento longitudinal adicional de la corredera 140 actúa para
mantener el elemento impulsor 150 en una alineación sustancialmente
vertical con el eje longitudinal. De ese modo configurado, una vez
acoplado por la corredera 140, el elemento impulsor 150 mantiene su
relación sustancialmente ortogonal con relación al eje longitudinal
a medida que se desplaza a través de la muesca de retención 122.
Alternativamente, el elemento impulsor 150a puede estar configurado
para residir en un espacio 146a entre las cuñas de leva 144a de la
corredera 140a, se representa en la figura 17B. Al igual que en la
forma de realización anterior, la base 152a del elemento impulsor
150a está configurada y adaptada para el acoplamiento deslizante con
el espacio 146a de la corredera 140a. Todavía adicionalmente, puesto
que el elemento impulsor 150a acopla la cuña de leva 144a de la
corredera 140a, el elemento impulsor 150a mantiene su relación
sustancialmente ortogonal con el eje longitudinal a medida que se
desplaza a través de la muesca de retención 122.
Aspectos adicionales de la presente invención se
establecen a continuación en la presente memoria en los siguientes
párrafos numerados.
1. Conjunto de herramientas que comprende:
- un yunque y un conjunto de cartucho, el
conjunto de cartucho, estando provisto de una pluralidad de
elementos de fijación y siendo móvil con relación al yunque entre
una posición separada y una posición aproximada, definiendo el
conjunto de cartucho y el yunque un espacio del tejido en la
posición aproximada;
- un elemento de sujeción que es móvil desde una
posición retraída hasta una posición avanzada para desplazar el
conjunto de cartucho con relación al yunque desde la posición
separada hasta la posición aproximada; y
- un elemento de sujeción dinámico colocado de
forma móvil con relación al yunque y el conjunto de cartucho, el
elemento de sujeción dinámico siendo móviles desde una posición
retraída hasta una posición avanzada para expulsar la pluralidad de
elementos de fijación desde el conjunto de cartucho; y
- un elemento de accionamiento que está
funcionalmente conectado al elemento de sujeción y al elemento de
sujeción dinámico, el elemento de accionamiento estado formado a
partir de un cable flexible y siendo móvil para desplazar el
elemento de sujeción y el elemento de sujeción dinámico entre sus
posiciones retraída y avanzada.
2. Conjunto de herramientas según el párrafo 1,
en el que el elemento de accionamiento incluye un cable de
accionamiento coaxial, el cable de accionamiento coaxial incluyendo
una funda exterior y una varilla central.
3. Conjunto de herramientas según el párrafo 2,
en el que la varilla central es móvil con relación a la varilla
central.
4. Conjunto de herramientas según el párrafo 2,
en el que la varilla central es axialmente móvil con respecto a la
funda exterior.
5. Conjunto de herramientas según el párrafo 2,
en el que la varilla central es giratoria con respecto a la funda
exterior.
6. Conjunto de herramientas según cualquiera de
los párrafos 2-5, en el que la funda exterior está
funcionalmente conectada al elemento de sujeción.
7. Conjunto de herramientas según cualquiera de
los párrafos 2-6, en el que la varilla central está
funcionalmente conectada al elemento de sujeción dinámico.
8. Conjunto de herramientas según cualquiera de
los párrafos anteriores, en el que el conjunto de herramientas está
articuladamente sujeto a una parte del cuerpo.
9. Conjunto de herramientas según el párrafo 8,
en el que el conjunto de herramientas está funcionalmente conectado
a un elemento de collar y el elemento de collar está articuladamente
sujeto a la parte del cuerpo.
10. Conjunto de herramientas según el párrafo 9,
en el que el conjunto de herramientas está montado de forma
giratoria en el elemento de collar.
11. Conjunto de herramientas según cualquiera de
los párrafos 2-10, en el que la varilla central del
cable coaxial está funcionalmente conectada al elemento de sujeción
dinámico de tal modo que el giro de la varilla central efectúa al
giro del elemento de sujeción dinámico el cual efectúa el giro del
conjunto de herramientas.
12. Conjunto de herramientas según cualquiera de
los párrafos anteriores, en el que el elemento de sujeción dinámico
incluye una primera parte de reborde colocada para acoplar una
superficie del yunque y una segunda parte de reborde colocada para
acoplar una superficie del conjunto de cartucho, las partes de
reborde primera y segunda estando colocadas para definir un espacio
máximo del tejido durante el desplazamiento del elemento de sujeción
dinámico desde su posición retraída a su posición avanzada.
13. Conjunto de herramientas según cualquiera de
los párrafos anteriores, en el que el elemento de sujeción es anular
y cuando está colocado alrededor de un extremo proximal del yunque y
del conjunto de cartucho y está en su posición avanzada, el elemento
de sujeción define un espacio máximo del tejido en un extremo
proximal del conjunto de herramientas.
14. Conjunto de herramientas según el párrafo 2,
en el que la varilla central está formada a partir de un cable
flexible enrollado.
15. Conjunto de herramientas según el párrafo 2,
en el que la funda exterior se selecciona a partir de grupo que
consta de malla de acero, plástico, Nitonol y Klevar.
16. Conjunto de herramientas según el párrafo 1,
adicionalmente incluyendo una cuchilla de bisturí asociada con el
elemento de sujeción dinámico.
17. Conjunto de herramientas según el párrafo
14, en el que la cuchilla de bisturí está formada en el elemento de
sujeción dinámico.
18. Conjunto de herramientas según cualquiera de
los párrafos 2-17, en el que el conjunto de
herramientas incluye un collar de accionamiento y la funda exterior
está unida al collar de accionamiento.
19. Conjunto de herramientas para su utilización
con una engrapadora quirúrgica comprendiendo:
- un yunque;
- un conjunto de cartucho provisto de por lo
menos una grapa, el conjunto de cartucho siendo móvil con relación
al yunque entre posiciones separada y aproximada;
- un elemento de sujeción colocado adyacente a
un extremo proximal del conjunto de herramientas, el elemento de
sujeción siendo móvil desde una posición retraída hasta una posición
avanzada para desplazar el yunque y el conjunto de cartucho hasta la
posición aproximada; y
- un elemento de sujeción dinámico colocado en
el interior del conjunto de herramientas y móvil desde una posición
retraída a través del conjunto de herramientas hasta una posición
avanzada para expulsar grapas desde el conjunto de cartucho, el
elemento de sujeción dinámico incluyendo una parte de reborde
superior que acopla una superficie del yunque y una parte de reborde
inferior que acopla una superficie del conjunto de cartucho, por lo
menos una de las partes de reborde superior e inferior estando
provista de una sección transversal arqueada a lo largo de un eje
transversal al eje longitudinal del conjunto de cartucho.
20. Conjunto de herramientas según el párrafo
19, adicionalmente incluyendo una cuchilla de bisturí asociada con
el elemento de sujeción dinámico.
21. Conjunto de herramientas según el párrafo 19
ó 20, en el que la cuchilla de bisturí está formada en una parte del
cuerpo central del elemento de sujeción dinámico.
22. Conjunto de herramientas según cualquiera de
los párrafos 19-21, en el que el conjunto de
cartucho incluye una corredera y un impulsor asociado con cada una
de la por lo menos una grapa, la corredera siendo accionada por el
elemento de cierre al acoplamiento con el impulsor para accionar el
impulsor al acoplamiento con la por lo menos una grapa para expulsar
la grapa del conjunto de cartucho.
23. Conjunto de herramientas según el párrafo
22, en el que el conjunto de cartucho incluye una pluralidad de
grapas e impulsores.
24. Conjunto de herramientas según cualquiera de
los párrafos 19-23, en el que el reborde superior y
el reborde inferior están sustancialmente alineados
verticalmente.
25. Conjunto de herramientas según cualquiera de
los párrafos 20-24, en el que la cuchilla del
bisturí está dispuesta en la parte del cuerpo central entre los
rebordes superior e inferior.
Se comprenderá que se pueden realizar diversas
modificaciones a las formas de realización dadas a conocer en la
presente memoria. Por ejemplo, aunque el conjunto de herramientas se
describe exclusivamente como un dispositivo de grapado, puede ser
utilizado para aplicar elementos de fijación distintos de grapas
incluyendo unos elementos de fijación de dos piezas. Por lo tanto,
la descripción anterior no debe ser considerada como limitativa,
sino únicamente como una ejemplificación de las formas de
realización preferidas. Los expertos en la materia contemplarán
otras modificaciones dentro del alcance de las reivindicaciones
adjuntas a la presente memoria.
Claims (5)
1. Dispositivo de grapado quirúrgico (10), que
comprende:
un conjunto de mango;
una parte de cuerpo endoscópica (18) y
un conjunto de herramientas (12) que está
montado para la articulación con respecto a la parte de cuerpo
endoscópica (18), que incluye:
- un yunque (14);
- un conjunto de cartucho de grapas (16) que incluye un cartucho (16a) provisto de una pluralidad de grapas quirúrgicas; y
- un elemento de sujeción dinámico (32) provisto de un rebaje (68), estando provisto el elemento de sujeción dinámico de un reborde superior (36a) para el acoplamiento del yunque y de un reborde inferior (36b) para el acoplamiento del conjunto de cartucho (16), siendo el yunque (14) y el conjunto de cartucho (16) móviles uno con relación al otro entre posiciones separadas y aproximadas, siendo el elemento de sujeción dinámico (32) móvil para expulsar las grapas desde el cartucho (16a) y para mantener un espacio máximo del tejido entre el yunque (14) y el conjunto de cartucho (16); y
caracterizado porque:
el dispositivo comprende además un elemento
flexible (62) unido al elemento de sujeción dinámico (32) y móvil de
forma distal para hacer avanzar el elemento de sujeción dinámico
(32) de forma distal a través del cartucho de grapas (16a), estando
conformado un extremo distal del elemento flexible (62) para
adaptarse al rebaje (68), de tal modo que el extremo distal del
elemento flexible (62) pueda ser recibido por el rebaje (68).
2. Dispositivo de grapado quirúrgico (10) según
la reivindicación 1, que comprende además un anillo de sujeción (20)
colocado alrededor de un extremo proximal del yunque (14) y de un
extremo proximal del conjunto de cartucho (16).
3. Dispositivo de grapado quirúrgico (10) según
la reivindicación 2, que comprende además una funda (64) colocada
alrededor del elemento flexible (62), estando conectada la funda
(64) al anillo de sujeción (20).
4. Dispositivo de grapado quirúrgico (10) según
la reivindicación 1, en el que el conjunto de herramientas (12) está
unido a un elemento de articulación (24), de tal modo que el
conjunto de herramientas (12) esté montado para la articulación con
respecto a la parte de cuerpo endoscópica (18).
5. Dispositivo de grapado quirúrgico (10) según
la reivindicación 1, que comprende además un collar de giro (22),
siendo el elemento flexible (62) giratorio para hacer girar el
conjunto de herramientas (12) alrededor del eje longitudinal del
collar de giro (22).
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US41608802P | 2002-10-04 | 2002-10-04 | |
| US416088P | 2002-10-04 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2348273T3 true ES2348273T3 (es) | 2010-12-02 |
Family
ID=32093815
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| ES03773180T Expired - Lifetime ES2337248T3 (es) | 2002-10-04 | 2003-10-06 | Conjunto de herramienta para un dispositivo de grapado quirurgico. |
| ES09013099T Expired - Lifetime ES2380101T3 (es) | 2002-10-04 | 2003-10-06 | Conjunto de instrumento para un dispositivo de grapado quirúrgico. |
| ES10006453T Expired - Lifetime ES2414857T3 (es) | 2002-10-04 | 2003-10-06 | Conjunto de instrumento para un dispositivo de grapado quirúrgico |
| ES08003414T Expired - Lifetime ES2348273T3 (es) | 2002-10-04 | 2003-10-06 | Dispositivo de grapado quirurgico. |
| ES10009127T Expired - Lifetime ES2377813T5 (es) | 2002-10-04 | 2003-10-06 | Conjunto de herramienta para un dispositivo de grapado quirúrgico |
| ES10165409T Expired - Lifetime ES2398459T3 (es) | 2002-10-04 | 2003-10-06 | Conjunto de herramienta para un dispositivo de grapado quirúrgico |
Family Applications Before (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES03773180T Expired - Lifetime ES2337248T3 (es) | 2002-10-04 | 2003-10-06 | Conjunto de herramienta para un dispositivo de grapado quirurgico. |
| ES09013099T Expired - Lifetime ES2380101T3 (es) | 2002-10-04 | 2003-10-06 | Conjunto de instrumento para un dispositivo de grapado quirúrgico. |
| ES10006453T Expired - Lifetime ES2414857T3 (es) | 2002-10-04 | 2003-10-06 | Conjunto de instrumento para un dispositivo de grapado quirúrgico |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES10009127T Expired - Lifetime ES2377813T5 (es) | 2002-10-04 | 2003-10-06 | Conjunto de herramienta para un dispositivo de grapado quirúrgico |
| ES10165409T Expired - Lifetime ES2398459T3 (es) | 2002-10-04 | 2003-10-06 | Conjunto de herramienta para un dispositivo de grapado quirúrgico |
Country Status (8)
| Country | Link |
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| US (14) | US7588177B2 (es) |
| EP (7) | EP2263562B2 (es) |
| JP (3) | JP4545589B2 (es) |
| AU (1) | AU2003279854B2 (es) |
| CA (1) | CA2500832C (es) |
| DE (2) | DE60333607D1 (es) |
| ES (6) | ES2337248T3 (es) |
| WO (1) | WO2004032762A1 (es) |
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- 2003-10-06 EP EP10165416A patent/EP2228017A1/en not_active Withdrawn
- 2003-10-06 US US10/529,800 patent/US7588177B2/en not_active Expired - Lifetime
- 2003-10-06 DE DE60333607T patent/DE60333607D1/de not_active Expired - Lifetime
- 2003-10-06 ES ES03773180T patent/ES2337248T3/es not_active Expired - Lifetime
- 2003-10-06 ES ES09013099T patent/ES2380101T3/es not_active Expired - Lifetime
- 2003-10-06 DE DE60330473T patent/DE60330473D1/de not_active Expired - Lifetime
- 2003-10-06 ES ES10006453T patent/ES2414857T3/es not_active Expired - Lifetime
- 2003-10-06 EP EP10006453.4A patent/EP2241266B1/en not_active Expired - Lifetime
- 2003-10-06 EP EP10165409A patent/EP2238917B1/en not_active Expired - Lifetime
- 2003-10-06 ES ES08003414T patent/ES2348273T3/es not_active Expired - Lifetime
- 2003-10-06 CA CA2500832A patent/CA2500832C/en not_active Expired - Lifetime
- 2003-10-06 ES ES10009127T patent/ES2377813T5/es not_active Expired - Lifetime
- 2003-10-06 EP EP09013099A patent/EP2163210B1/en not_active Expired - Lifetime
- 2003-10-06 EP EP08003414A patent/EP1927319B1/en not_active Expired - Lifetime
- 2003-10-06 AU AU2003279854A patent/AU2003279854B2/en not_active Expired
- 2003-10-06 WO PCT/US2003/031652 patent/WO2004032762A1/en active Application Filing
- 2003-10-06 ES ES10165409T patent/ES2398459T3/es not_active Expired - Lifetime
- 2003-10-06 EP EP03773180A patent/EP1545333B1/en not_active Expired - Lifetime
- 2003-10-06 JP JP2004543421A patent/JP4545589B2/ja not_active Expired - Fee Related
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2007
- 2007-11-28 US US11/998,037 patent/US8033442B2/en not_active Expired - Lifetime
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2008
- 2008-05-28 US US12/128,004 patent/US7690547B2/en not_active Expired - Lifetime
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2009
- 2009-08-31 US US12/550,993 patent/US7819896B2/en not_active Expired - Lifetime
- 2009-11-19 JP JP2009264421A patent/JP4934186B2/ja not_active Expired - Fee Related
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2010
- 2010-10-08 US US12/900,778 patent/US8061577B2/en not_active Expired - Lifetime
- 2010-11-26 JP JP2010264404A patent/JP2011083618A/ja not_active Withdrawn
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2011
- 2011-09-26 US US13/245,239 patent/US8408442B2/en not_active Expired - Lifetime
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2013
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2016
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2017
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2018
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2020
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