ES2287155T3 - Grapadora quirurgica. - Google Patents
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- ES2287155T3 ES2287155T3 ES01967641T ES01967641T ES2287155T3 ES 2287155 T3 ES2287155 T3 ES 2287155T3 ES 01967641 T ES01967641 T ES 01967641T ES 01967641 T ES01967641 T ES 01967641T ES 2287155 T3 ES2287155 T3 ES 2287155T3
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
- A61B17/0684—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil having a forming anvil staying above the tissue during stapling
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/128—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for applying or removing clamps or clips
- A61B17/1285—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for applying or removing clamps or clips for minimally invasive surgery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00646—Type of implements
- A61B2017/00668—Type of implements the implement being a tack or a staple
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00672—Locating means therefor, e.g. bleed back lumen
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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
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/062—Measuring instruments not otherwise provided for penetration depth
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Abstract
Una grapadora quirúrgica para recibir y suministrar una grapa, incluyendo dicha grapadora: un eje, un localizador deslizantemente móvil con respecto al eje entre una posición avanzada donde el localizador sobresale más allá de un extremo libre del eje para entrar en un lugar de punción en un vaso de transporte de líquido, para colocar por ello el extremo libre del eje en el lugar de punción, y una posición situada hacia atrás donde el localizador está retirado con relación al eje, cabalgando dicha grapa sobre el localizador en la práctica y pudiendo deslizar hacia adelante encima, y un accionador para mover la grapa hacia adelante a lo largo del localizador y para retirar el localizador en coordinación con el movimiento de la grapa de tal manera que el localizador se retire de entre las patas de la grapa a tiempo para permitir que las patas de la grapa grapen conjuntamente bordes opuestos del lugar de punción.
Description
Grapadora quirúrgica.
La presente invención se refiere a un
instrumento, aquí llamado una grapadora quirúrgica, para cerrar una
punción en un vaso de transporte de líquido aplicando una grapa a
través de la punción con el fin de efectuar un cierre. La invención
se refiere en concreto a grapadoras quirúrgicas para cerrar
punciones en vasos sanguíneos.
Al realizar procedimientos de cateterización,
tales como angiografía o angioplastia, generalmente se introduce un
catéter en el sistema vascular penetrando primero la piel, tejidos
subyacentes y vaso sanguíneo con una aguja hueca de punta afilada.
A continuación, se introduce comúnmente un alambre de guía a través
del lumen de la aguja hueca y se hace que entre en el vaso
sanguíneo seleccionado. Posteriormente la aguja se quita
típicamente del alambre de guía y se alimenta una combinación de un
dilatador y/o introductor (o un introductor solo) sobre el alambre
de guía y se empuja a través de la piel de manera que entre en el
vaso sanguíneo. El alambre de guía se puede quitar entonces y se
introduce un catéter deseado para llevar a la práctica el
procedimiento a través del lumen del introductor y se avanza a
través del sistema vascular hasta que el extremo operativo del
catéter se coloca apropiadamente. Después de la terminación del
procedimiento de cateterización se retirará el catéter operativo y
posteriormente también se quitará el dilatador y/o introductor de la
herida. Después de este procedimiento, hay que cerrar la punción
del vaso con el fin de evitar la pérdida de sangre a través del
agujero de la punción.
La herida se cierra normalmente manteniendo
presión externa sobre el vaso hasta que la punción se cierra
naturalmente. Este procedimiento puede tardar aproximadamente 30
minutos, siendo el tiempo generalmente mayor si el paciente es
hipertensivo o anticoagulado. El procedimiento también puede ser
incómodo para el paciente e implica tiempo profesional costoso por
parte del personal del hospital. Se han empleado otras técnicas de
presión tales como vendas de presión, bolsas de arena o pinzas,
pero éstas también implican asegurar que el paciente permanezca sin
moverse durante un período de tiempo prolongado y sea monitorizado
para asegurar la efectividad del procedimiento.
Se han desarrollado varios dispositivos en los
últimos tiempos que realizan una obstrucción en la zona de la
punción con el fin de evitar el sangrado. Por ejemplo, las Patentes
de Estados Unidos 4.852.568 y 4.890.612 describen un dispositivo
que utiliza un tapón de colágeno que, cuando se coloca en el agujero
del vaso sanguíneo, absorbe fluidos corporales, se hincha y realiza
un cierre hermético. Otros dispositivos parecidos a tapones, por
ejemplo, US 5.222.974 y US 5.282.827, describen un dispositivo de
tapón y anclaje, colocándose el anclaje dentro del vaso y el tapón
de colágeno fuera del vaso, intercalando por ello la punción entre
ambos y efectuando un cierre.
WO 98/17179 describe una grapadora quirúrgica
que tiene un tubo localizador de sangre junto al cabezal de
grapado. Un alambre de guía pasa a través de un agujero en el
extremo del tubo y a través de un agujero hueco en el tubo, de modo
que la grapadora pueda ser alimentada por el alambre de guía y hasta
el lugar de punción. Cuando el dispositivo llega al lugar de
punción, la punta del tubo entra en el flujo de sangre dentro de la
arteria y pasa sangre a través del tubo y sale por el extremo distal
en un punto visible para el clínico. El clínico puede accionar
entonces el mecanismo de grapado en el conocimiento de que el
cabezal de grapado está en el lugar de punción en la pared
arterial.
Un objeto de la presente invención es
proporcionar un instrumento para cerrar por grapado una punción en
un vaso de transporte de líquido.
Según la presente invención se facilita una
grapadora quirúrgica incluyendo un eje, un localizador que se puede
mover deslizantemente con respecto al eje entre una posición
avanzada donde el localizador sobresale más allá de un extremo
libre del eje para entrar en un lugar de punción en un vaso de
transporte de líquido, para colocar por ello el extremo libre del
eje en el lugar de punción, y una posición situada hacia atrás
donde el localizador está retirado con relación al eje, estando
dicha grapa a horcajadas del localizador en la práctica y pudiendo
deslizar hacia delante en él, y un accionador para mover la grapa
hacia delante a lo largo del localizador y para retirar el
localizador en coordinación con el movimiento de la grapa de tal
manera que el localizador se retire de entre las patas de la grapa
a tiempo para permitir que las patas de la grapa grapen
conjuntamente bordes opuestos del lugar de punción.
En otro aspecto la invención proporciona un
método de cerrar por grapado un lugar de punción en un vaso de
transporte de líquido en un cuerpo humano o animal, incluyendo los
pasos de:
introducir un mecanismo de grapado en la
posición del vaso;
colocar el mecanismo de grapado en el lugar de
punción por medio de un localizador asociado con el mecanismo de
grapado y que sobresale hacia delante de él, detectando el
localizador la posición del lugar de punción entrando en el vaso en
el lugar;
suministrar una grapa al lugar de punción, y
deformar la grapa para cerrarlo; y
en coordinación con la suministración y
deformación de la grapa, extraer el localizador del lugar de punción
de tal manera que el localizador se retire completamente del vaso
antes de que la grapa se deforme completamente para cerrar el lugar
de punción.
Preferiblemente, los pasos de suministrar y
deformar la grapa y en coordinación con ellos extraer el localizador
se efectúan accionando un solo control en un mecanismo de
accionamiento de la grapadora.
Una realización de la invención se describirá
ahora, a modo de ejemplo, con referencia a los dibujos acompañantes,
en los que:
La figura 1 es una vista en perspectiva de una
realización de una grapadora quirúrgica según la invención.
La figura 1(A) es una vista en
perspectiva ampliada del extremo libre del eje de la grapadora de la
figura 1.
La figura 2 es una vista en perspectiva de la
grapadora de la figura 1 con el mango izquierdo quitado.
La figura 3 es una vista en perspectiva de la
grapadora de la figura 1 con el mango derecho y el eje quitados.
La figura 4 es una vista en perspectiva
despiezada de los componentes vistos en la figura 3, omitiendo
también el mango izquierdo.
La figura 5 es una vista en perspectiva
despiezada de los componentes internos en el extremo libre del
eje.
La figura 6 es una vista en perspectiva de los
componentes internos en el extremo libre del eje en la posición de
predisparo y omitiendo el lado izquierdo del eje.
La figura 7 es una vista en alzado lateral de
los componentes de la figura 6 en la posición de predisparo.
La figura 8 es una vista en alzado frontal de
los componentes de la figura 6 en la posición de predisparo.
La figura 9 es una vista en perspectiva de los
componentes internos del extremo libre, que representa la posición
de los componentes en el ciclo medio con la grapa completamente
formada.
La figura 10 es una vista en alzado lateral de
los componentes de la figura 9 en la posición
post-disparo.
La figura 11 es una vista en perspectiva del
tubo localizador de sangre con vistas ampliadas de las porciones
delantera y trasera, figura 11A y figura 11B respectivamente.
La figura 12 es una vista en alzado en sección
lateral de la porción delantera de una realización alternativa del
tubo localizador de sangre de la grapadora.
La figura 13 es una vista en perspectiva de la
porción delantera del tubo localizador de sangre representado en la
figura 12.
La figura 13(A) es una vista en
perspectiva de la porción delantera de una realización alternativa
del tubo localizador de sangre representado en la figura 12.
La figura 14(A) es una vista en
perspectiva de la grapa quirúrgica en el estado de predisparo
(predeformado).
La figura 14(B) es una vista en
perspectiva de la grapa quirúrgica en el estado de
post-disparo (deformado).
La figura 15 es una vista en perspectiva
ampliada del mecanismo excéntrico.
La figura 16 es una vista en alzado lateral del
mecanismo excéntrico.
La figura 17 es una vista en alzado lateral de
la sección de eje del dispositivo y orificio de aspiración.
Y la figura 18 es una vista de extremo de la
grapa quirúrgica, tubo localizador e inserto.
Con referencia a los dibujos, la grapadora
incluye un eje rígido 10 que se extiende desde un alojamiento de
plástico moldeado 12 en forma de una empuñadura de pistola. El eje
10, que es hueco para acomodar varios componentes móviles a
describir, incluye lados derecho e izquierdo 10A, 10B
respectivamente que están fijados conjuntamente en el extremo
distal libre por una sección de tubo termocontráctil 91 en
combinación con pasadores de interferencia y cavidades de
acoplamiento 15A y 15B (figuras 4 y 5) a lo largo de los bordes de
la punta distal, y en el extremo próximo por pasadores 17A que
acoplan en un ajuste de interferencia con cavidades correspondientes
17B (figura 2 y 3) capturadas dentro del alojamiento 12.
Igualmente, el alojamiento 12 incluye lados izquierdo y derecho
12A, 12B respectivamente.
La parte principal de la longitud expuesta del
eje 10 tiene una sección transversal circular constante, pero en su
extremo libre el eje 10 tiene una porción 14 de diámetro
incrementado que tiene un perfil de "bala". Un extremo de esta
porción de bala 14 está ahusado hacia una ranura de salida de grapa
16 mientras que el otro extremo está ahusado a la sección restante
del eje, que vuelve al alojamiento 12. La relación del diámetro
máximo de la porción de bala 14 al diámetro de la sección restante
del eje expuesto es aproximadamente 5:4. Un manguito
termocontráctil 91 asienta a nivel con la superficie de la porción
de bala 14, para asegurar la entrada atraumática, de forma
percutánea, en el tejido.
La razón del perfil de bala es que el eje 10 sea
lo más atraumático posible durante la introducción en el cuerpo
para minimizar la cantidad de fuerza y dilatación del tejido
necesarias al deslizar el dispositivo de forma percutánea sobre un
alambre de guía 18 y sobre la superficie de un vaso sanguíneo
adyacente a un agujero de punción, como se describirá. En una
realización alternativa, no representada, la porción de bala 14 es
de sección transversal oval, siendo el eje principal del óvalo
coincidente con la ranura de salida de grapa 16, con el fin de
minimizar la longitud circunferencial para una anchura de grapa
dada.
La porción de bala 14 del eje 10 aloja una grapa
40 y un mecanismo de suministro de grapa (figuras 4 a 7). El
mecanismo de suministro de grapa incluye un yunque basculable 24 y
un par de elementos de accionamiento en forma de varilla, a saber
un soporte de yunque alargado 30 y un formador de grapa alargado 52,
pudiendo deslizar éste último en el eje 10 y ser accionado por un
mecanismo excéntrico accionado por disparo 62 en el alojamiento del
mango 12.
El yunque 24 tiene un par de dedos rectos 24A en
la parte delantera y un par de brazos basculantes inclinados hacia
abajo 24B en la parte trasera. El yunque 24 está montado
basculantemente en la porción de bala 14 por un par de alas 26 que
pueden pivotar en rebajes 28 en el lado derecho 10A del eje 10 (las
alas 26 se retienen en los rebajes por el lado inferior de
salientes 54 en el formador 52).
El basculamiento del yunque 24 lo efectúa el
mecanismo excéntrico 62 mediante el soporte de yunque 30, que es
axialmente deslizante dentro del lado derecho del eje 10A en canal
32. El extremo delantero del soporte de yunque 30 está bifurcado
para formar dos brazos 34 que tienen salientes laterales 36 (figuras
6 y 7). Los brazos deslizan en rebajes 38 en el lado derecho del
eje 10A. El soporte de yunque 30 se puede mover, por el mecanismo
excéntrico 62, de una posición avanzada, figuras 6 y 7, donde los
brazos 34 se extienden debajo de las alas de soporte del yunque 25
para soportar los dedos de formación de yunque 24A directamente en
la parte delantera de una grapa quirúrgica 40 a suministrar, a una
posición situada hacia atrás, figura 10, donde los brazos 34 están
retirados debajo de los brazos basculantes inclinados hacia abajo
24B en la parte trasera del yunque 24 con el fin de bascular el
yunque hacia la izquierda (según se ve en la figura 10) y desplazar
los dedos 24A del recorrido de la grapa 40. El ángulo de inclinación
de los brazos basculantes 24B se puede incrementar para producir la
separación de las dos mitades de eje, además de desplazar los dedos
24A del recorrido de la grapa formada, para contribuir a la
liberación de la grapa. Esto se logra cuando el yunque (en su
posición completamente basculada) aplica presión al lado inferior
del formador 52 y la superficie superior del eje derecho 10A.
Con referencia también a las figuras 11, 11A y
11B, un tubo localizador de sangre hueco 92 puede deslizar
axialmente dentro del eje 10 en un canal 44 en el soporte de yunque
30 y en un canal en forma de U opuesto 53 en el formador de grapa
52. El tubo 92 se extiende toda la longitud del eje 10 y tiene una
sección transversal constante, generalmente oval o alargada,
excepto en su punta distal 14 donde el tubo localizador 92 se forma
en un agujero estrecho 96 y en una región rizada 94 hacia la parte
trasera del tubo 92 que se forma para dejar que solamente el
alambre de guía 18 y no la sangre salgan por la parte trasera del
tubo localizador.
Bajo la acción del mecanismo excéntrico 62 el
tubo 92 puede deslizar axialmente en el eje 10 entre una posición
avanzada, figuras 6 y 7, donde su extremo delantero sobresale más
allá de la porción de bala 14 del eje 10 bajo la influencia de un
resorte de lámina 88 a describir, y una posición situada hacia
atrás, figuras 9 y 10, donde el extremo delantero del tubo 92 está
retirado dentro de la porción de bala 14 detrás de los dedos 24A
del yunque 24 durante la rotación de la excéntrica 62.
La finalidad del tubo localizador de sangre 92
es seguir un alambre de guía previamente colocado 18 a un lugar de
punción en un vaso sanguíneo, para colocar por ello el extremo libre
de porción de bala 14 del eje 10 contra la pared exterior del vaso
sanguíneo en el lugar de punción. Para colocar adecuadamente la
porción de bala 14, el extremo delantero del tubo 92 debe penetrar
realmente en la pared del vaso sanguíneo en el lugar de punción y
esto se indica porque fluye sangre a través del tubo 92 y sale a
través de un orificio de salida de sangre 93 (figura 11) en el
tubo. Un canal (no representado) en la parte del lado izquierdo 10B
del eje 10 dentro del alojamiento 12 proporciona comunicación entre
el orificio 93 y un orificio de salida de sangre 50 (figura 1) en
el lado del alojamiento 12B, de modo que la sangre que vuelve a
través del tubo 92 sea visible en el exterior del alojamiento.
Se puede fijar un adaptador de orificio de
salida de sangre 51 (figura 1) al agujero del orificio de salida de
sangre 50 mediante un ahusamiento luer macho de adaptación 51A para
mejorar la visibilidad de la sangre que sale. El adaptador de
orificio de salida de sangre tiene un diámetro interno reducido, con
relación al agujero del orificio de salida de sangre 50, que para
un flujo constante de sangre incrementa la presión de la sangre
saliente, haciendo un efecto de chorro de la sangre saliente.
En la ausencia del adaptador de orificio de
salida de sangre, el agujero ahusado luer hembra del orificio de
salida de sangre concuerda con el del ahusamiento luer macho de una
jeringa estándar haciendo posible en cualquier tiempo durante el
uso del dispositivo inyectar fluido mediante el orificio de salida
de sangre al lumen del tubo localizador de manera que salga en su
punta distal. Esto puede ser necesario ocasionalmente para quitar
del lumen del tubo localizador la sangre coagulada y el tejido
blando atrapado. Alternativamente, se puede inyectar un medio de
contraste radioopaco mediante el tubo localizador para confirmar por
fluoroscopia la posición relativa de la punta distal del tubo
localizador con respecto a la de la pared del vaso sanguíneo, o se
puede inyectar fluidos inyectables por razones de diagnóstico o
terapéuticas.
El orificio de salida de sangre 93 está
dimensionado de manera que tenga una zona mínima correspondiente a
la zona de entrada de sangre disponible en la punta distal; sin
embargo, es más estrecho (en un aspecto transversal) que el
diámetro del alambre de guía 18 para evitar que el alambre de guía
salga accidentalmente por el orificio de salida de sangre durante
la introducción, en lugar de salir por el extremo próximo previsto
del tubo localizador.
Se ha hallado que la forma natural de las
heridas de punción en paredes arteriales es alargada más bien que
redonda. Mientras que el agujero se forma introduciendo instrumentos
generalmente de sección transversal redonda, la pared tiende a
abrirse generalmente a lo largo de una línea transversal que está en
la dirección de la circunferencia de la arteria (más bien que a lo
largo del eje de la arteria). Al tener un tubo localizador de
sangre generalmente oval, el tubo localizador (cuando es introducido
por el clínico con el eje principal del óvalo perpendicular al eje
de la arteria), ajustará más naturalmente dentro del agujero
arterial. La consecuencia de esto es que los bordes de la herida
que se han de grapar conjuntamente, están más próximos que si se
usase un tubo de sección transversal circular.
A su vez, esto tiene la consecuencia de que la
grapa usada no tiene que ser tan grande, y a su vez, se pueden
reducir las dimensiones del eje, que debe acomodar la grapa en su
estado no formado, dando lugar a menos trauma para el tejido en el
que se introduce el eje.
Otra consecuencia de tener una sección
transversal generalmente oval o alargada para el tubo localizador es
que el tubo se dispondrá más en el centro de la punción que con un
tubo redondeado. La presente realización tiene una grapa que
cabalga sobre el tubo localizador, incrementando por ello la
probabilidad de la grapa cierre la herida alargada en su centro más
bien que hacia un extremo u otro de la herida.
El agujero 96 en la parte delantera del tubo 92
tiene una porción aproximadamente circular 96A en la punta situada
más hacia delante del tubo que es de diámetro mayor que la anchura
de la porción restante 96B del agujero 96. La porción 96B tiene
forma de una ranura alineada con el eje principal de la sección
transversal alargada del tubo 92 y se inclina hacia atrás de la
porción circular 96A. El alambre de guía 18, que pasa a través del
tubo 92, figura 11, se elige de manera que sea de diámetro
suficientemente más pequeño que el diámetro del agujero 96A en el
extremo delantero del tubo 92 para introducir fácilmente el alambre
de guía 18 en el tubo 92 y pasarlo a través del agujero 96A. Sin
embargo, el alambre de guía también se elige de manera que sea
demasiado grande para ajustar dentro del resto 96B del agujero 96.
De esta forma, el alambre de guía 18 se retiene en el agujero 96A,
y el tamaño de agujero 96A establece un límite superior al diámetro
de alambre de guía que puede ser usado con el dispositivo. Se
podría introducir un cuello estrecho o constricción en el agujero
96 justo encima del agujero 96A (en los puntos indicados por 96C)
para asegurar que alambres de guía muy pequeños se retengan dentro
del agujero ampliado 96A, pero en general esto no es necesario
porque el alambre de guía se suministrará normalmente con el
dispositivo, o el dispositivo solamente se suministrará para uso
con un alambre de guía de un calibre concreto.
El rizo trasero 94 y el agujero de la punta 96A
están colocados para promover que el alambre de guía esté a lo
largo de la superficie inferior curvada del tubo, es decir, la
porción del tubo que está en una línea directa entre el agujero en
el extremo rizado y el agujero 96A. Esto ayuda a evitar que el
alambre de guía 18 se coloque contra el interior del orificio de
salida de sangre 93 y evite la salida de sangre, figuras 11A y
11B.
La naturaleza curvilínea del agujero 96
incrementa la zona de entrada disponible de manera que concuerde con
la zona disponible dentro del cuerpo del tubo localizador con el
alambre de guía 18 in situ.
El agujero en forma de ranura 96B se inclina
alejándose del agujero circular 96A para facilitar la introducción
en el agujero del vaso y para reducir la posibilidad de trauma en la
pared interior del vaso enfrente del agujero que se grapa. Esto se
logra porque el alambre de guía 18 que sobresale de agujero 96A
tenderá a empujar la pared opuesta del vaso alejándola de la punta
del tubo localizador, y el punto en el que el alambre de guía
sobresale (debido a la retención en el agujero 96A) es la parte más
alejada hacia adelante de la punta. Así, la forma de la punta se
hace aerodinámica lejos del agujero 96A para evitar que alguna parte
de la punta entre o dañe de otro modo las paredes interiores del
vaso. Además, los bordes periféricos 95 del agujero 96 están
curvados hacia dentro para evitar bordes afilados que podrían dañar
tejido blando y la pared del vaso.
El extremo distal de una realización alternativa
de un tubo localizador 42 se representa en las figuras 12 y 13.
Esta realización también tiene una sección transversal alargada
sustancialmente constante, que en este caso converge a un agujero
de alambre de guía aproximadamente circular 46 en la punta más hacia
delante del tubo. El alambre de guía 18, que pasa a través del tubo
42, se elige generalmente de manera que sea de diámetro
suficientemente más pequeño que el diámetro del agujero 46 para que
pueda haber un intervalo adecuado para que la sangre vuelva a
través del tubo 42 incluso en la presencia del alambre de guía. Sin
embargo, se disponen más agujeros 46A en lados opuestos del tubo 42
justo detrás del agujero delantero 46 para permitir un acceso más
fácil de la sangre al interior del tubo en casos donde el alambre de
guía 18 puede no dejar un intervalo suficientemente grande para el
paso de sangre únicamente a través del agujero 46. De hecho, los
tres agujeros 46, 46A, 46A forman respectivas porciones de un solo
agujero delantero, siendo en realidad tres lóbulos conectados,
todos conectados por canales limitados 47, y todos en comunicación
con el interior del tubo.
Una realización alternativa se representa en la
figura 13(A) donde los tres agujeros 46, 46A y 46A, aunque
constituyen colectivamente el agujero delantero del tubo 42, son
independientes uno de otro. De nuevo, el agujero 46 en la parte
delantera del tubo está dimensionado para recibir un alambre de guía
de máximo tamaño y los agujeros 46A están dimensionados para dejar
que entre un flujo suficiente de sangre en el tubo localizador.
Puede surgir un problema en dispositivos de este
tipo donde se usa un alambre de guía sobredimensionado que cierra
el hueco interior del tubo localizador de sangre y por ello evita el
retroceso de sangre a través del tubo. Para evitar esta situación,
el lóbulo 46 a través del que emerge el alambre de guía en la punta
del tubo de las figuras 12, 13 y 13A es de un diámetro más pequeño
que el agujero interno del tubo. Las dimensiones de este lóbulo 46
establecen un diámetro máximo del alambre de guía a usar con el
dispositivo, y aseguran que incluso cuando se use este alambre de
guía de diámetro máximo, todavía haya suficiente holgura interna
dentro del tubo agujero para permitir un flujo intenso de sangre a
través del tubo desde los otros lóbulos 46A.
La grapa 40 cabalga sobre el tubo localizador de
sangre 92 dentro de la porción de bala 14 del eje 10, véase las
figuras 6 y 8, y puede deslizar encima de él hacia delante hacia el
extremo libre de la porción de bala 14. En particular (véase
también la vista ampliada de la figura 14), la grapa 40 incluye una
parte trasera o porción de base 40A de la que se extienden
perpendicularmente en cada extremo patas respectivas 40B que
terminan en puntas afiladas. La porción de base 40A y las patas 40B
están sustancialmente en un plano común excepto con respecto a una
porción central 40C de la porción de base 40A que se deforma en una
dirección perpendicular a las patas 40B de manera que tenga una
forma en \Omega (omega) generalmente complementaria del perfil
externo en sección transversal del tubo localizador de sangre 92 y
la sección transversal interna de un inserto 160, a describir. La
sección de base 40A está precurvada entre 150º y 170º en los puntos
A y B equidistantes del centro de la base, colocada para maximizar
el cierre de la grapa cerrada (y es relevante para la profundidad
de las alas formadoras 54 en el formador 52). La sección de base
también se deforma en los puntos C y D con el fin de estrechar la
anchura en sección transversal del alambre en ambos puntos,
dirigiendo por ello la grapa para curvarla en estos puntos. La
grapa 40 se monta en el tubo localizador de sangre 92 de tal manera
que la porción central 40C de la grapa asiente en la mitad superior
del tubo 92, según se ve en la figura 6 y 8, donde la sección
estrecha abierta de la forma de omega es aproximadamente igual a la
anchura del tubo y con las patas 40B apuntando hacia adelante en
lados opuestos del tubo 92. La profundidad de la porción central
40C de la grapa 40 es tal que las patas 40B de la grapa estén
sustancialmente directamente en lados opuestos del eje central del
tubo 92. Esto asegurará que la grapa 40 se coloque en el centro a
través del agujero de la punción en el vaso sanguíneo. Con el fin
de evitar que el alambre de guía 18 manche la grapa 40 cuando ésta
se cierre en el lugar de punción, el agujero 96A está desviado por
debajo del plano que contiene las patas 40B de la grapa, figura
8.
El inserto metálico 160 se recibe en un rebaje
en el lado izquierdo del eje 10B dentro de la sección de bala 14.
El inserto 160 proporciona soporte mecánico para la sección de omega
40C de la grapa 40 durante el proceso de formación de la grapa y es
enganchado por el formador 52 durante la fase de expulsión de grapa
del proceso con el fin de separar ambas mitades de la sección de
bala para fácil liberación de la grapa. El inserto está perfilado
de manera que corresponda generalmente con el perfil externo de la
porción en forma de omega 40C de la grapa. En el extremo distal el
perfil del inserto se ahúsa de manera que se aproxime estrechamente
a la porción en forma de omega de la grapa 40C (figura 18). Esto
tiene el efecto de ofrecer soporte mecánico a la porción en forma
de omega de la grapa durante el proceso de formación de la grapa,
durante el que la sección de base se curva alrededor de los dedos
de yunque. A su vez, este movimiento de curvatura hace que la omega
se abra hacia arriba o aplane. El inserto metálico evita que suceda
esto permitiendo solamente que la base de la grapa se deforme
alrededor del yunque. El sistema de enclavamiento en forma de omega
entre la grapa 40 y el inserto 160 (figura 18) también estabiliza
la grapa, verticalmente, dentro de la salida de la grapa durante el
proceso de formación, permitiendo al mismo tiempo la fácil
liberación de la grapa una vez formada, debido a la zona de
contacto relativamente pequeña entre la grapa y el inserto.
El formador de grapa 52 tiene una sección
transversal que se adapta a la del tubo localizador de sangre 92 y
puede deslizar en el tubo localizador de sangre 92 axialmente dentro
del eje 10. El formador 52 está situado detrás de la grapa 40 en el
tubo 92 y es operado por el mecanismo excéntrico 62. El formador 52
tiene en su extremo delantero un par de brazos de formación 54 que
están conformados de modo que, cuando el formador 52 sea desplazado
hacia delante por el mecanismo excéntrico 62, la grapa 40 se mueva
contra y deforme alrededor de los dedos de yunque 24A de modo que
las patas 40B de la grapa se cierren (figura 9) sobre el lugar de
punción. La superficie de los brazos de formación que contactan la
grapa 55 puede estar perfilada para adaptación a la geometría en
sección transversal de la grapa. Este perfil de adaptación
estabiliza la grapa en las superficies de formación de los brazos
de formación 54 durante el contacto de alta presión con la grapa
durante la formación y el cierre de la grapa. Durante el movimiento
hacia delante de la grapa, las patas de la grapa deslizan hacia el
yunque 24 a lo largo de una pista definida por la ranura de salida
de grapa 16 entre las mitades opuestas de la porción de bala 14. La
ranura 16 proporciona un ligero ajuste de interferencia en las patas
de la grapa 40B para evitar que la grapa 40 se mueva hacia delante
durante el almacenamiento del dispositivo o antes del disparo. La
ranura 16 también evita que la grapa gire en el plano horizontal
(figura 7 y 10) durante su recorrido hacia delante. Una vez
terminada la formación de la grapa alrededor del yunque, se quita la
fuerza de formación del formador 52 por un rebaje en la excéntrica,
se baja el yunque y el formador se avanza de nuevo para expulsar la
grapa del dispositivo. Durante este movimiento hacia delante (fase
de expulsión), los bordes inclinados 52A y 52B del formador
enganchan con el inserto metálico 160 abrir la sección de bala del
conjunto de eje facilitando así la liberación de la grapa.
El mecanismo excéntrico 62 se puede ver en la
figura 3 y en las vistas ampliadas de las figuras 15 y 16. El
mecanismo 62 consta de una primera excéntrica 58 y una segunda
excéntrica 60 montadas en un eje común 62 que asienta en un rebaje
64 en el lado izquierdo 10A del eje (figura 4) y un rebaje
correspondiente (no representado) en el lado derecho 10B. El
gatillo 56 está montado igualmente en el eje por un par de ejes
cortos 66 que son recibidos en un rebaje de asiento de gatillo 68
en cada mitad del eje 10, figura 4.
Un pasador de accionamiento 70 se extiende a
través de las excéntricas primera y segunda 58, 60. Este pasador de
accionamiento es accionado por una superficie excéntrica de
accionamiento 72 (figura 3) dispuesta en el gatillo 56, de modo que
cuando se aprieta el gatillo, la superficie de accionamiento mueve
el pasador de accionamiento en una dirección hacia la izquierda
alrededor del eje 62. Dado que el pasador de accionamiento se
extiende a través de ambas excéntricas 58, 60 del mecanismo 62, las
excéntricas se giran simultáneamente el mismo ángulo que el
determinado por el apriete del gatillo. El uso de este mecanismo
excéntrico asegura la exacta temporización y desplazamientos
mecánicos positivos de todos los componentes móviles y el movimiento
exacto de los componentes uno con relación a otro. La geometría de
los pasadores de pivote del gatillo 66 y la superficie de
accionamiento 72 con relación al pivote de excéntrica 62 y el
pasador de accionamiento por excéntrica 70 está configurada para
minimizar la rotación del gatillo a solamente 23 grados mientras que
la excéntrica gira un total de 90 grados. Esta configuración
también proporciona una ventaja mecánica que el gatillo suministra
al pasador de accionamiento por excéntrica 70 de aproximadamente
1:4. Esta geometría también está configurada para distribuir la
mejor ventaja mecánica en la fase durante el ciclo de formación de
grapa, que requiere las fuerzas de formación más altas, lo que
tiene la ventaja de minimizar el esfuerzo de disparo y de asegurar
un esfuerzo de disparo constante en todo el ciclo. El gatillo 56
incluye además una palanca de trinquete 73B, representada en la
figura 3, que engancha con la tira de trinquete 73A, que está
montada en el mango derecho 12A, figura 3. Este sistema de
trinquete sin retorno asegura que el ciclo de disparo de la grapa
sea ininterrumpido, no repetible y que proporcione una indicación
positiva de que el dispositivo ha sido usado.
Con referencia de nuevo a la figura 3, se ha
colocado un resorte de lámina 88 en un rebaje en el lado izquierdo
10A del eje y un rebaje correspondiente (no representado) en el lado
derecho 10B. Los extremos libres del muelle están formados en un
bucle de manera que pivoten libremente en los rebajes de esquina
curvados en los que asienta y de facilitar el montaje. El vértice
de este muelle se coloca en una ranura 74 en la porción rizada 94
del tubo localizador de sangre 92 asumiendo así el papel de seguidor
de excéntrica para el tubo localizador de sangre. Este seguidor de
excéntrica del tubo localizador de sangre 74 es accionado por la
primera excéntrica 58. Igualmente, la primera excéntrica 58 actúa
en un primer seguidor de excéntrica 76, mientras que la segunda
excéntrica 60 actúa en los seguidores de excéntrica de soporte de
yunque 78A y 78B. La forma de las excéntricas primera y segunda 58,
60 se representa en alzado en la figura 16 (la segunda excéntrica
60 se representa en contorno de puntos puesto que la oculta la
primera excéntrica). La figura 16 también representa el pasador de
accionamiento 70, y un puntal de refuerzo 80 montado entre las
excéntricas primera y segunda diametralmente enfrente del pasador de
accionamiento 70.
Las excéntricas se representan en las posiciones
iniciales en la figura 15 y 16. El apriete completo del gatillo (un
ángulo de 23 grados) hace que las excéntricas giren hacia la
izquierda 90 grados.
El vértice del resorte de lámina 88 que engancha
con y opera como un seguidor de excéntrica para el tubo localizador
de sangre (vértice de resorte de lámina) actúa contra la superficie
trasera 82 de la primera excéntrica 58. Cuando la primera
excéntrica gira hacia la izquierda desde la posición representada en
la figura 15, se incrementa la distancia entre el seguidor de
excéntrica del tubo localizador de sangre 74 y el eje 62. Esto hace
que el tubo localizador de sangre retroceda cuando se aprieta el
gatillo.
El primer seguidor de excéntrica 76 actúa contra
la superficie delantera 84 de la primera excéntrica 58. De nuevo la
distancia entre el primer seguidor de excéntrica 76 y el eje 62
aumenta a través de las etapas iniciales del apriete del gatillo.
El perfil de la superficie 84 está diseñado con dos eficiencias no
lineales distintas, que pasan de baja eficiencia mecánica/alto
desplazamiento a alta eficiencia mecánica/bajo desplazamiento. La
primera tasa de subida es para desplazamiento de la grapa de su
posición inicial a la formación inicial contra el yunque, que
requiere el desplazamiento más grande de la grapa con carga mínima.
La segunda tasa de subida no lineal está diseñada para
correlacionar la eficiencia mecánica de las excéntricas con el
perfil de carga requerido para formar la grapa cerrada, minimizar
el esfuerzo de disparo requerido y asegurar un esfuerzo de disparo
constante en todo el ciclo. Una sección en forma de V 84A de la
sección delantera 84 hace que el formador 52 interrumpa
momentáneamente su movimiento hacia delante cuando la grapa se haya
formado completamente. El efecto de esto es liberar momentáneamente
la presión de la grapa formada contra el yunque, dejando que el
yunque baje. La geometría de la punta distal del formador está
diseñada para proporcionar suficiente tensión elástica intrínseca
para permitir que los brazos de formación 54 compriman más la grapa
formada, una vez que el yunque ha bajado, para cerrar más la grapa
formada. Dado que la excéntrica continúa girando, el perfil elevado
84B en la excéntrica hace que el formador avance de nuevo hacia
adelante, expulsando la grapa del dispositivo.
Se puede ver que una joroba elevada 82A en el
perfil de la superficie trasera 82 de la primera excéntrica está
situada casi diametralmente enfrente de la sección en forma de V
84A. La razón de esto es aumentar la tasa a la que el tubo
localizador de sangre es sacado del lugar de punción justo antes de
que la grapa se forme y libere completamente. La intención es dejar
el tubo en la punción hasta lo más tarde posible para proporcionar
soporte a las paredes del vaso sanguíneo durante el mayor tiempo
posible y también asegurar que el cabezal del dispositivo
permanezca centrado sobre el agujero de la punción. El tubo
localizador de sangre 92 es empujado hacia adelante por el resorte
de lámina del tubo localizador de sangre 88 que también mantiene la
presión entre el vértice del muelle y la superficie trasera 82 de la
primera excéntrica 58.
El resorte de lámina del tubo localizador de
sangre 88 permite que el tubo localizador sea desplazado en una
dirección próxima (de nuevo al eje del dispositivo) contra la
tensión del muelle en el caso de que el tubo localizador encuentra
una resistencia significativa durante la introducción del
dispositivo, para evitar el trauma innecesario en tejidos blandos,
el vaso o su pared trasera.
Un ejemplo de la especial utilidad de esto es si
la grapadora llega demasiado lejos en el vaso, de modo que la punta
del tubo 92 encuentre la pared interior. El tubo localizador de
sangre se desplazará entonces de nuevo al eje, y puede estar
diseñado de manera que sobresalga a través del extremo del
alojamiento del mango para dar una indicación visual de que el
dispositivo se ha insertado contra la pared. Además, el dispositivo
puede estar diseñado de modo que el orificio de salida de sangre 93
en el tubo 92 se ponga en correspondencia con el orificio de salida
de sangre 50 en el alojamiento del mango cuando el tubo se desplace
hacia atrás, de modo que el clínico notará la interrupción del el
flujo de sangre cuando el tubo encuentre la pared interior del vaso
de esta forma.
El mecanismo excéntrico 62, sin embargo, realiza
desplazamientos mecánicos positivos para extraer el tu-
bo localizador en el tiempo apropiado, para asegurar que no haya posibilidad de formación de la grapa mientras el
tubo localizador esté en una posición avanzada y que interfiera potencialmente con la formación de la
grapa.
bo localizador en el tiempo apropiado, para asegurar que no haya posibilidad de formación de la grapa mientras el
tubo localizador esté en una posición avanzada y que interfiera potencialmente con la formación de la
grapa.
Otra razón de dejar el tubo localizador de
sangre en el agujero de la punción hasta lo más tarde posible es
que la retracción continuada del tubo realiza la eversión o el giro
hacia fuera de los bordes opuestos de la punción herida y
contribuye a la penetración de las patas de la grapa en la pared
arterial. La eversión de los bordes de la punción ayuda a evitar la
formación de trombos dentro del vaso. Otra razón de dejar el tubo
localizador de sangre en el agujero de la punción hasta lo más tarde
posible es asegurar que el cabezal de la grapadora permanezca
centrado sobre el agujero durante el proceso de suministro de
grapas. Cuando el tubo localizador está completamente retirado,
solamente el alambre de guía queda dentro de la herida, y éste se
retirará fácilmente de la herida cerrada después de sacar la
grapadora del lugar de punción.
El seguidor de excéntrica de soporte de yunque
78B actúa contra la superficie trasera 90 de la segunda excéntrica
60. Se puede ver que esta superficie trasera 90 proporciona a la
sección 90A el mayor aumento de distancia con relación al eje de
aproximadamente 60 a 90 grados por debajo de la horizontal. La razón
de esto es que el yunque se mantiene en posición hasta que la grapa
ha sido formada y la presión en el formador se ha relajado
ligeramente para dejar que el yunque baje. El yunque se mantiene en
posición durante los 60 grados iniciales de rotación por el
seguidor de excéntrica de soporte de yunque 78A que está en contacto
con la superficie excéntrica 98 de la excéntrica 60, evitando que
el soporte de yunque 30 se desplace de su posición inicial. La
superficie excéntrica 98 para los primeros 60 grados de rotación
excéntrica está a una distancia constante del eje de excéntrica 62
(en pa-
rada).
rada).
En la práctica, la grapadora está inicialmente
en la configuración de "predisparo" representada en las figuras
6 a 8. El extremo delantero del tubo localizador de sangre 92 está
en una posición completamente avanzada que sobresale más allá del
extremo libre de la porción de bala 14 del eje 10, el soporte de
yunque 30 está en una posición completamente avanzada con sus
brazos 36 extendiéndose debajo de las alas de soporte del yunque
25, asegurando que los dedos de yunque 24A estén directamente en la
parte delantera de la grapa 40, el formador 52 está en una posición
completamente retirada lejos de los dedos de yunque 24A, y la grapa
40 está en su posición completamente retirada contra los brazos de
formación 54.
En esta configuración, el extremo externo de un
alambre de guía previamente colocado 18 se introduce en el agujero
96A en el extremo delantero del tubo localizador de sangre 92 y
alimenta a través del tubo 92 hasta que sale por un orificio de
salida del alambre de guía en la parte trasera del alojamiento 12.
La grapadora es alimentada ahora a lo largo del alambre de guía 18
hasta que la punta 95 del tubo 92 entra en el lumen del vaso
sanguíneo a través del agujero de la punción del vaso. Esto lo
indica la sangre que sale por el orificio de salida de sangre 50 o,
si está presente, el adaptador 51. En este punto, el extremo
delantero de la porción de bala 14 del eje 10 descansará contra la
pared exterior del vaso sanguíneo.
Ahora se aprieta el gatillo 56, haciendo que las
excéntricas del mecanismo excéntrico 62 giren 90 grados. Como se ha
mencionado, el extremo trasero de cada uno del tubo localizador de
sangre 92, el soporte de yunque 30 y el formador 52 están acoplados
al mecanismo excéntrico mediante seguidores de excéntrica y el
siguiente movimiento coordinado de estos componentes tiene lugar
cuando las excéntricas giran 90 grados.
\newpage
(A).
0 grados: Grapadora en configuración de
predisparo.
32 grados: formador 52 suficientemente
hacia delante para fijar la grapa contra los dedos de yunque 24A, el
tubo localizador de sangre comienza a retirarse. En este punto las
patas de la grapa habrán perforado la pared del vaso sanguíneo,
pero la grapa todavía no se ha deformado completamente.
50 grados: formador 52 suficientemente
hacia adelante para deformar las patas de la grapa alrededor de los
dedos de yunque 24A y cerrar la grapa en el lugar de punción: tubo
localizador de sangre 42 completamente retirado. En algún punto
entre 32 y 50 grados, el tubo localizador de sangre se habrá
retirado de entre las patas de la grapa a tiempo para dejar que se
cierren. Éste deberá permanecer todo lo posible para proporcionar
soporte a las paredes del vaso sanguíneo durante el mayor tiempo
posible.
65 grados: fuerza de fijación liberada de
la grapa (debido a rebaje en el perfil de la excéntrica). El soporte
de yunque 30 comienza a retirarse.
75 grados: soporte de yunque 30 retirado
suficientemente para actuar contra los brazos basculantes inclinados
del yunque 24B. Los dedos de yunque 24A comienzan a caer.
83 grados: soporte de yunque 30
completamente retirado. Los dedos de yunque 24A han caído para
permitir la liberación de la grapa. La tensión intrínseca en los
brazos del formador 54 cierra más la grapa. El formador 52 comienza
a desplazarse de nuevo hacia delante para expulsar la grapa. El
formador 52 comienza a interferir con el inserto 160 para extender
la porción de bala 14 del eje para permitir la libre liberación de
la grapa.
90 grados: formador 52 completamente
hacia adelante; grapa expulsada del dispositivo.
El uso de excéntricas en el mecanismo excéntrico
62 asegura la exactitud de la secuencia y la temporización relativa
entre eventos además de asegurar los desplazamientos mecánicos
positivos de todos los componentes.
En otra realización del dispositivo antes
descrito, a la terminación del ciclo descrito anteriormente, la
rotación adicional de la excéntrica hace que el soporte de yunque 30
vuelva a su posición completamente avanzada, elevando los dedos de
yunque 24A a su posición subida detrás de la grapa formada que se
mantiene en los brazos de formación 54. El formador se retira
entonces en una dirección próxima (de vuelta al eje) haciendo que la
parte trasera de la grapa cerrada entre en los dedos subidos del
yunque 24A, para ser expulsada positivamente de dentro de los
brazos de formación 54 y el dispositivo. Los movimientos adicionales
del soporte de yunque y del formador pueden ser facilitados por
lóbulos adicionales en la excéntrica 58; o alternativamente movidos
por muelle, asistidos y temporizados por ranuras radiales colocadas
apropiadamente en la excéntrica 58 para que el seguidor de
excéntrica del soporte de yunque se pueda mover hacia delante y el
seguidor de excéntrica del formador se puede desplazar hacia
atrás.
atrás.
En otra realización el gatillo activa un ciclo
automático de disparo, no representado. Un muelle de tensión unido
a las excéntricas es liberado de su estado extendido con el fin de
girar la excéntrica de accionamiento un arco de 90 grados
produciendo los mismos movimientos de los componentes que los
descritos anteriormente.
En una realización alternativa, no representada,
una vez que la grapa se ha formado, el extremo situado hacia
delante del formador 52 se retrae y engancha brazos de tracción en
el soporte de yunque 30 haciendo que se mueva en una dirección
hacia atrás. Cuando lo hace, engancha con el extremo trasero del
yunque 24, que está inclinado hacia abajo al recorrido de la
corredera móvil. En alas centralmente opuestas se extienden desde
el yunque y están situadas de manera que pivoten en ranuras de ala
opuestas formadas en el lado derecho 10A del eje. Una vez
enganchado con la corredera, el extremo trasero del yunque es
empujado hacia arriba haciendo que pivote alrededor de las alas y
arquee hacia abajo el extremo situado hacia delante del yunque.
Cuando lo hace, se desengancha de la grapa de modo que el
dispositivo se pueda sacar del tracto de punción a lo largo del
alambre de
guía.
guía.
En otra realización el perfil inverso 82 en la
primera excéntrica 58 que engancha con el seguidor de excéntrica 74
en el tubo localizador de sangre 92 se extiende de modo que cuando
se termine el ciclo de formación de grapa, la primera excéntrica
siga girando haciendo que el tubo localizador de sangre se desplace
más en una dirección próxima. El tubo localizador de sangre tiene
en su extremo distal alas que cuando se mueve en una dirección
próxima, enganchan con los brazos de tracción del soporte de yunque
30 haciendo que se mueva en una dirección próxima y enganche los
brazos basculantes del yunque, desenganchando por ello el extremo
distal del yunque de la grapa formada. En esta realización la
segunda excéntrica es redundante y se puede omitir.
En otra realización, figura 17, la cabeza de
bala 14 del eje 10, que se aproxima a la pared del vaso sanguíneo
208, incluye varios orificios de aspiración 200. Estos orificios
están en comunicación con un adaptador de aspiración 202 mediante
capilares 204 dentro de la sección de eje. Se suministra aspiración,
desde una salida de aspiración de pared estándar o una bomba de
aspiración independiente, al adaptador de aspiración 202 mediante
una espita de apertura/cierre 206. Una vez que el dispositivo está
en posición en la pared arterial, como indica la sangre que sale
por el orificio de salida de sangre, la espita 206 se gira a la
posición de abertura, para suministrar por ello aspiración a los
orificios 200 en la cabeza de bala 14. A su vez, esto aspira la
pared del vaso sanguíneo 208 contra la cara del cabezal 14 con el
fin de estabilizarla durante el suministro de la grapa. Una vez
suministrada, la aspiración se desactiva con el fin de sacar el
dispositivo de la pared del vaso sanguíneo y el tracto del
tejido.
Claims (17)
-
\global\parskip0.900000\baselineskip
1. Una grapadora quirúrgica para recibir y suministrar una grapa, incluyendo dicha grapadora:un eje,un localizador deslizantemente móvil con respecto al eje entre una posición avanzada donde el localizador sobresale más allá de un extremo libre del eje para entrar en un lugar de punción en un vaso de transporte de líquido, para colocar por ello el extremo libre del eje en el lugar de punción, y una posición situada hacia atrás donde el localizador está retirado con relación al eje, cabalgando dicha grapa sobre el localizador en la práctica y pudiendo deslizar hacia adelante encima, yun accionador para mover la grapa hacia adelante a lo largo del localizador y para retirar el localizador en coordinación con el movimiento de la grapa de tal manera que el localizador se retire de entre las patas de la grapa a tiempo para permitir que las patas de la grapa grapen conjuntamente bordes opuestos del lugar de punción. - 2. Una grapadora quirúrgica según la reivindicación 1, incluyendo además un yunque contra el que la grapa se puede deformar para grapar conjuntamente bordes opuestos del lugar de punción.
- 3. Una grapadora quirúrgica según la reivindicación 1 o 2, donde el accionador mueve la grapa mediante un formador alargado deslizante axialmente del eje.
- 4. Una grapadora quirúrgica según la reivindicación 2 o 3, donde el yunque puede bascular con relación al eje entre una primera posición donde el yunque está en una posición para enganche por la grapa y una segunda posición donde el yunque está libre de la grapa.
- 5. Una grapadora quirúrgica según la reivindicación 4, donde el accionador incluye además un mecanismo basculante para bascular el yunque en coordinación con el movimiento del localizador y la grapa de tal manera que el yunque bascule de la primera posición a la segunda posición después del cierre de la grapa en el lugar de punción.
- 6. Una grapadora quirúrgica según la reivindicación 5, donde el mecanismo basculante para bascular el yunque incluye un elemento alargado deslizante axialmente dentro del eje.
- 7. Una grapadora quirúrgica según cualquier reivindicación precedente, donde el localizador tiene una sección transversal generalmente oval.
- 8. Una grapadora quirúrgica según cualquier reivindicación precedente, donde el extremo situado hacia delante del localizador está ahusado.
- 9. Una grapadora quirúrgica según cualquier reivindicación precedente, donde las patas de la grapa están sustancialmente directamente en lados opuestos de un eje central del localizador en la práctica.
- 10. Una grapadora quirúrgica según cualquier reivindicación precedente, donde el localizador incluye un tubo hueco que tiene un agujero en el extremo situado hacia delante para poder detectar flujo de líquido dentro de un vaso de transporte de líquido para localizar por ello el lugar de punción en el vaso.
- 11. Una grapadora quirúrgica según la reivindicación 10, donde un alambre de guía es soportado dentro del tubo localizador y donde dicho alambre de guía emerge de dicho tubo en el agujero.
- 12. Una grapadora quirúrgica según la reivindicación 11, donde el agujero en el extremo situado hacia delante del tubo localizador está dispuesto en el tubo con el fin de hacer que el alambre de guía salga desviado de entre las patas de la grapa.
- 13. Una grapadora quirúrgica según cualquier reivindicación precedente, donde una porción del eje tiene un diámetro incrementado en su extremo libre.
- 14. Una grapadora quirúrgica según cualquier reivindicación precedente, donde el eje está unido a un mango y el accionador incluye un mecanismo excéntrico montado en el mango.
- 15. Una grapadora quirúrgica según la reivindicación 14, en cuanto dependiente de la reivindicación 3, donde el mecanismo excéntrico incluye una excéntrica que mueve el formador hacia adelante para deformar la grapa contra el yunque, y que está conformada para relajar la fuerza de accionamiento una vez que la grapa se ha formado para permitir por ello la grapa salga del yunque.
- 16. Una grapadora quirúrgica según la reivindicación 14 o 15, donde el mecanismo excéntrico es accionado por gatillo.
- 17. Una grapadora quirúrgica según cualquier reivindicación precedente, incluyendo además dicha grapa recibida por la grapadora.
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|---|---|---|---|
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| IE2000/0724 | 2000-09-08 | ||
| IE20000724 | 2000-09-08 | ||
| IE20000722 | 2000-09-08 |
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|---|---|
| ES2287155T3 true ES2287155T3 (es) | 2007-12-16 |
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ID=26320303
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| Application Number | Title | Priority Date | Filing Date |
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| ES01967641T Expired - Lifetime ES2287155T3 (es) | 2000-09-08 | 2001-09-07 | Grapadora quirurgica. |
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| EP (3) | EP1294289B8 (es) |
| JP (2) | JP2004508092A (es) |
| AT (3) | ATE361702T1 (es) |
| AU (5) | AU8800901A (es) |
| CA (2) | CA2421856A1 (es) |
| DE (3) | DE60144328D1 (es) |
| ES (1) | ES2287155T3 (es) |
| IE (1) | IES20010815A2 (es) |
| WO (3) | WO2002019920A1 (es) |
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- 2001-09-07 AU AU8800901A patent/AU8800901A/xx active Pending
- 2001-09-07 WO PCT/IE2001/000117 patent/WO2002019920A1/en not_active Ceased
- 2001-09-07 IE IE20010815A patent/IES20010815A2/en not_active IP Right Cessation
- 2001-09-07 AT AT01967641T patent/ATE361702T1/de not_active IP Right Cessation
- 2001-09-07 AU AU2001288006A patent/AU2001288006A1/en not_active Abandoned
- 2001-09-07 AT AT01967640T patent/ATE503423T1/de not_active IP Right Cessation
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- 2001-09-07 AU AU8800801A patent/AU8800801A/xx active Pending
- 2001-09-07 AU AU2001288008A patent/AU2001288008B8/en not_active Ceased
- 2001-09-07 WO PCT/IE2001/000115 patent/WO2002019915A1/en not_active Ceased
- 2001-09-07 EP EP01967641A patent/EP1294289B8/en not_active Expired - Lifetime
- 2001-09-07 DE DE60144328T patent/DE60144328D1/de not_active Expired - Lifetime
- 2001-09-07 JP JP2002524410A patent/JP2004508092A/ja active Pending
- 2001-09-07 ES ES01967641T patent/ES2287155T3/es not_active Expired - Lifetime
- 2001-09-07 US US09/948,813 patent/US6582452B2/en not_active Expired - Lifetime
- 2001-09-07 DE DE60143324T patent/DE60143324D1/de not_active Expired - Lifetime
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- 2001-09-07 JP JP2002524408A patent/JP2004508090A/ja active Pending
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2003
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2005
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2008
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2009
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