ES2356757T3 - Herramienta de corte ultrasónica. - Google Patents

Herramienta de corte ultrasónica. Download PDF

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ES2356757T3
ES2356757T3 ES06709922T ES06709922T ES2356757T3 ES 2356757 T3 ES2356757 T3 ES 2356757T3 ES 06709922 T ES06709922 T ES 06709922T ES 06709922 T ES06709922 T ES 06709922T ES 2356757 T3 ES2356757 T3 ES 2356757T3
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Michael John Radley Young
Stephen Michael Radley Young
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SRA Developments Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320069—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic for ablating tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320072—Working tips with special features, e.g. extending parts
    • A61B2017/320074—Working tips with special features, e.g. extending parts blade
    • A61B2017/320075—Working tips with special features, e.g. extending parts blade single edge blade, e.g. for cutting

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  • Orthopedic Medicine & Surgery (AREA)
  • Surgical Instruments (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)
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Abstract

Herramienta quirúrgica ultrasónica que comprende unos medios de guía de ondas alargados (1), una fuente de vibraciones ultrasónicas acoplada o acoplable de manera operativa a un extremo proximal de dichos medios de guía de ondas, un elemento operativo adyacente a un extremo distal generalmente cilíndrico de dichos medios de guía de ondas, y que comprende unos medios de arista (2) que se extienden radialmente determinados entre un par de medios de ranura (4) sustancialmente paralelos que se extienden longitudinalmente con respecto a los medios de guía de ondas desde un extremo distal de la misma, caracterizada porque dicho elemento operativo está curvado en un plano transversal con respecto al de los medios de arista y en el que la fuente de vibraciones ultrasónicos comprende una fuente de vibraciones ultrasónicas de modo torsional.

Description

La presente invención se refiere a una herramienta quirúrgica ultrasónica, tal como una herramienta laparoscópica ultrasónica para cortar tejidos blandos del cuerpo humano. Más en particular, pero no exclusivamente, se refiere a una herramienta de este tipo que presenta una punta operativa que está perfilada para mejorar la ergonomía de su utilización.
Las herramientas de corte con vibración ultrasónica han demostrado ser muy beneficiosas para la cirugía, particularmente la cirugía laparoscópica (denominada cirugía de “orificio clave”). Se introduce una herramienta quirúrgica estrecha, alargada, por lo general junto con un sistema de visión endoscópica por fibra óptica, por una pequeña incisión en el cuerpo de un paciente, y se dirige a una zona exacta de tejido que requiere cirugía. En procedimientos más complejos, pueden introducirse otras herramientas, por medio de otras incisiones, dirigirse a continuación al mismo lugar, aunque esta acción se evita siempre que sea posible. En cualquier caso, un objetivo básico de la cirugía laparoscópica es minimizar el tamaño y número de incisiones (o “accesos”) realizados en el cuerpo del paciente.
Las limitaciones inherentes en el trabajo con herramientas estrechas, largas, en un espacio reducido bajo visión a distancia (por ejemplo en unos medios de pantalla de monitor) implican que el diseño ergonómico de las herramientas laparoscópicas es de suma importancia.
Las herramientas ultrasónicamente vibratorias aportan importantes beneficios en dichos procedimientos poco invasivos, puesto que pueden activarse de manera selectiva para cortar únicamente tejidos objetivo, y pueden adaptarse fácilmente para cauterizar el tejido a medida que se corta. De este modo, los vasos sanguíneos tanto pueden cortarse como sellarse en una operación, por ejemplo, reduciendo el sangrado de manera significativa. Dicho corte hemostático es particularmente ventajoso en la cirugía laparoscópica, en la que la visibilidad es un beneficio.
Las vibraciones ultrasónicas de modo torsional han demostrado ser particularmente eficaces, puesto que pueden transmitirse eficazmente y con precisión a tejidos objetivo seleccionados con una fuga externa mínima de energía ultrasónica, mientras que las vibraciones ultrasónicas de modo longitudinal (o de onda de compresión) alternativas pueden conducir a la propagación no conveniente de energía longitudinalmente fuera de un extremo distal de una herramienta a tejidos (no objetivo) adyacentes.
Una herramienta laparoscópica ultrasónicamente vibratoria convencional, sea de modo torsional
o modo longitudinal, comprende un elemento o elementos operativo(s) que se extiende(n) desde un extremo distal de una guía de ondas alargada. Un cirujano manipula la herramienta asiendo una empuñadura montada adyacente al extremo proximal de la guía de ondas, que se extiende a través de un acceso limitado en un cuerpo de paciente. Los elementos operativos están dispuestos de este modo de manera ideal para ser utilizados en tejidos de manera sustancial directamente en línea con el eje de la guía de ondas. Sin embargo, para trabajar en un tejido situado a un lado del eje de la guía de ondas, el cirujano debe retirar parcialmente la herramienta y alinearla de nuevo, limitada por las dimensiones del acceso y manipulando en todo momento la herramienta por su extremo proximal. La reposición continua requerida en un procedimiento complejo puede conducir rápidamente a la fatiga por parte del cirujano. Existe, por lo tanto, la necesidad de proporcionar una herramienta ergonómicamente superior que permita al cirujano trabajar durante más tiempo y con un control mejorado.
Tal como se ha mencionado anteriormente, otra cuestión importante en laparoscopia es una visualización clara de los elementos operativos de la herramienta y el tejido objetivo. Se introduce un sistema de visión endoscópica a través de otra incisión, pero este puede llegar al tejido objetivo en un ángulo tan agudo con la herramienta que la visualización tridimensional resulta difícil.
Por lo tanto, un objetivo de la presente invención consiste en proporcionar una herramienta de corte y/o coagulación ultrasónica que evite los inconvenientes anteriores y permita a un usuario dirigir una cirugía laparoscópica de manera más conveniente y con un control mejorado.
En la solicitud de patente europea nº EP 1 138 264 A1, se da a conocer una herramienta quirúrgica ultrasónica que presenta las características del preámbulo de la reivindicación 1.
Según la presente invención, se proporciona una herramienta quirúrgica ultrasónica que comprende unos medios de guía de ondas alargados acoplados de manera funcional o que pueden acoplarse en un extremo proximal a una fuente de vibraciones ultrasónicas, dispuesta adyacente a un extremo distal generalmente cilíndrico y con un elemento operativo que comprende unos medios de arista que se extienden radialmente determinados entre un par de medios de ranura sustancialmente paralelos que se extienden longitudinalmente con respecto a la guía de ondas desde un extremo distal de la misma, caracterizado porque dicho elemento operativo está curvado en un plano transversal al de los medios de arista y en el que la fuente de vibraciones ultrasónicos comprende una fuente de vibraciones ultrasónicas de modo torsional.
Preferentemente, el elemento operativo es cónico hacia su extremo distal.
Ventajosamente, el elemento operativo comprende dos caras convergentes que se extienden transversalmente al plano de curvatura del elemento operativo.
Dicha primera cara convergente puede ser de este modo curvada cóncava y dicha segunda cara convergente curvada convexa.
El elemento operativo puede comprender una punta distal sustancialmente roma.
Preferentemente, los medios de arista se extienden en un plano que generalmente corta en dos partes iguales los de las caras convergentes.
Ventajosamente, la primera cara convergente, cóncava, converge hacia el plano de los medios de arista más gradualmente que la segunda cara convergente convexa.
El elemento operativo comprende de este modo más material entre el plano de los medios de arista y la cara convergente, cóncava que entre el plano de los medios de arista y la cara convergente convexa.
Preferentemente, los medios de arista forman un borde cortante del elemento operativo.
Ventajosamente, el elemento operativo comprende un elemento de mordaza que puede desplazarse giratoriamente de manera controlable hacia el acoplamiento con los medios de arista y fuera del mismo.
El elemento de mordaza puede ser curvado de manera que se corresponda con los medios de arista.
El elemento de mordaza puede comprender una superficie de contacto formada de este modo para que pueda cooperar con los medios de arista.
En una forma de realización preferida, la herramienta comprende una fuente de vibraciones ultrasónicas de modo torsional.
La herramienta comprende preferentemente unos medios con los cuales puede hacerse girar de manera seleccionable el elemento operativo alrededor de un eje longitudinal de la guía de ondas para que se presente ante un elemento de tejido deseado en el cual debe actuar.
A continuación se describe más particularmente una forma de realización de la presente invención, a título de ejemplo, y haciendo referencia a los dibujos adjuntos, en los que:
La figura 1 es una vista en planta superior de una punta de una herramienta ultrasónica que se incluye la presente invención, en una primera etapa de su producción;
la figura 2 es un vista en sección transversal de la punta de la herramienta representada en la figura 1, por la línea II-II;
la figura 3 es una vista en planta superior de la punta de la herramienta representada en la figura 1, en una segunda etapa de su producción;
la figura 4 es una vista en sección transversal de la punta de la herramienta representada en la figura 3, por la línea IV-IV;
la figura 5 es una vista en planta superior de la punta de la herramienta representada en la figura 1, en una última etapa de su producción; y
la figura 6 es una vista de alzado del extremo distal de la punta de la herramienta representada en la figura 5.
Haciendo referencia a continuación a las figuras, y a las figuras 1 y 2 en particular, una guía de ondas 1 cilíndrica, alargada, estrecha comprende un material duro, resistente a la corrosión, idealmente titanio o una aleación del mismo. La figura 1 muestra la guía de ondas 1 después de una primera etapa de la producción de una punta de herramienta en la misma. Dos ranuras paralelas 4 se extienden longitudinalmente en la guía de ondas 1 desde su extremo distal 3, determinando entre las mismas una nervadura 2. Dichas ranuras 4 se unen en la superficie cilíndrica de la guía de ondas 1 en su extremo proximal 6, y profundizan hacia el extremo distal 3 de la guía de ondas 1. La nervadura 2 se extiende en paralelo a un eje longitudinal 9 de la guía de ondas 1. (Para los fines de la presente descripción, la
En una segunda etapa de la producción de la punta de la herramienta, cuyo resultado se muestra en las figuras 3 y 4, el extremo distal 3 de la guía de ondas 1 se hace cónico mediante la mecanización de un par de superficies que se extienden verticalmente 11, 12 en la misma. Las superficies 11, 12 convergen hacia el extremo distal 3, pero si se prolongaran únicamente se encontrarían más allá del mismo. De este modo, dejan una punta distal plana, estrecha 8, que es más ancha que la nervadura 2.
Las superficies 11, 12 comienzan a nivelarse entre sí en sus extremos proximales, pero se extienden en ángulos ligeramente distintos, extendiéndose una primera superficie 11 en un ángulo menor con respecto a la nervadura 2 que una segunda superficie 12. Por lo tanto, la punta 8 es asimétrica, quedando ligeramente más material en un lado de la nervadura 2 adyacente a la primera superficie 11 que en un lado de la nervadura 2 adyacente a la segunda superficie 12.
En sección transversal (figura 4), la guía de ondas 1 comienza a continuación a adoptar la forma de una cuchilla con una primera cara 14 y una segunda cara 15 formadas por las respectivas superficies 11, 12.
En la etapa final de la producción, cuyo resultado se muestra en las figuras 5 y 6, una parte distal de la guía de ondas 1 está curvada alrededor de un mandril que se extiende verticalmente, de manera que la primera cara 14 adopta un perfil cóncavo 17 y la segunda cara 15 adopta un perfil convexo ligeramente más inclinado 18. Por lo tanto, la nervadura 2 también está curvada, y la punta 8 se desvía hacia fuera, separándose del eje 9 de la guía de ondas 1, hasta que se extiende más allá de un volumen cilíndrico que se extiende de manera distante de una extremidad distal de la guía de ondas 1.
La punta de la guía de ondas representada en la figura 5 forma la cuchilla de corte de una herramienta quirúrgica laparoscópica vibratoria de manera ultrasónica. La guía de ondas 1 está acoplada en su extremo proximal a un generador de vibraciones ultrasónicas de modo torsional y a una empuñadura que puede ser asida por un cirujano, y está dispuesta a lo largo de casi toda su longitud con un manguito para aislar el tejido, a través del cual pasa, de las vibraciones ultrasónicas transmitidas por la guía de ondas 1. La nervadura 2, y en particular, las zonas de las ranuras 4 inmediatamente al lado de la nervadura 2 transmitirán mejor la energía ultrasónica al tejido con el que ha entrado en contacto la guía de ondas 1.
La conicidad de la guía de ondas 1 hacia la punta distal 8 produce una herramienta con un perfil cortador mucho más fino que lo sería un extremo distal no cónico 3 de una guía de ondas 1. La conicidad también facilita la etapa de curvar la guía de ondas 1 alrededor del mandril. Otra ventaja consiste en que la conicidad hacia la punta distal 8, que está ahora considerablemente desplazada del eje longitudinal/torsional 9, reduce el momento de inercia de la punta 8. Esto reduce cualquier tendencia a generar unos modos vibratorios transversales desequilibrados, no convenientes, adyacentes a la punta distal 8. Tal como puede apreciarse en la figura 6, la punta distal 8 se recorta hasta un mínimo compatible con el soporte de la nervadura 2. Si fuera mucho más estrecha, podría presentar el riesgo de cortar físicamente en el tejido cuando se introduce en el cuerpo, mientras que una herramienta laparoscópica ideal es funcionalmente roma hasta el momento en que se activa.
La forma de la herramienta representada permite utilizarla como una sonda o disector muy delicado hasta que se lleva una parte distal de la nervadura 2 entra en contacto con el tejido que debe tratarse, y se hace vibrar de manera ultrasónica, momento en el cual se convierte en una herramienta de corte/coagulación muy precisa.
Dicha forma es particularmente ventajosa respecto a la de las herramientas existentes cuando la guía de ondas 1 se realiza de manera que puede girar alrededor del eje 9, por ejemplo utilizando una disposición tal como la que se da a conocer en nuestra solicitud de patente británica en trámite nº 0500937.8. Esta permite aplicar la punta distal 8 al tejido alrededor del extremo 3 de la guía de ondas 1, simplemente “seleccionando” una alineación angular deseada de la punta distal 8, deslizándola a continuación, por ejemplo, bajo un vaso adyacente, y activándola de manera ultrasónica para realizar el corte requerido.
Una punta operativa convencional de una herramienta laparoscópica ultrasónica se extiende longitudinalmente desde el extremo distal de la guía de ondas, y de este modo puede actuar únicamente con facilidad en el tejido directamente delante de la herramienta. El cirujano tendría que realinear a continuación toda la herramienta alargada, limitada por el tamaño de la incisión por la que pasa, para trabajar en un tejido seleccionado que no esté directamente en el recorrido inicial de la herramienta. La forma de la punta 8 representada proporciona al cirujano un radio de acción mucho mayor sin requerir colocar de nuevo toda la herramienta, una mejora ergonómica importante.
El perfil de la punta 8 distal representado también puede utilizarse con un mecanismo de mordazas no vibratorias que puede girar de manera controlable, de la forma utilizada en las herramientas dispuestas linealmente convencionales. Dicho mecanismo comprende un elemento de mordaza (no representado) con una curvatura que se corresponde con la de la nervadura 2, que se llevaría a entrar en contacto con una superficie superior de la nervadura 2 para atrapar el tejido que debe cortarse y coagularse entre las mismas. Opcionalmente, una superficie de contacto del elemento de mordaza estaría
5 de este modo perfilada para cooperar con el perfil en sección transversal de la nervadura 2 y por lo menos las zonas laterales de las ranuras 4 cuando ésta se cierra.
El perfil de la punta distal 8 representado es particularmente ventajoso en procedimientos tales
como una colecistectomía en la vesícula biliar, en los cuales se prefieren planos de corte curvados sobre
cortes planos sencillos.
10 Evidentemente, con la punta distal 8 desplazada hacia fuera desde la guía de ondas 1, resulta también más fácil ver en el campo de visión de un visor endoscópico dispuesto convencionalmente. La visibilidad mejorada ayuda al cirujano en la realización de procedimientos rápidos y precisos.

Claims (10)

1. Herramienta quirúrgica ultrasónica que comprende unos medios de guía de ondas alargados (1), una fuente de vibraciones ultrasónicas acoplada o acoplable de manera operativa a un extremo proximal de dichos medios de guía de ondas, un elemento operativo adyacente a un extremo distal generalmente cilíndrico de dichos medios de guía de ondas, y que comprende unos medios de arista
(2) que se extienden radialmente determinados entre un par de medios de ranura (4) sustancialmente paralelos que se extienden longitudinalmente con respecto a los medios de guía de ondas desde un extremo distal de la misma, caracterizada porque dicho elemento operativo está curvado en un plano transversal con respecto al de los medios de arista y en el que la fuente de vibraciones ultrasónicos comprende una fuente de vibraciones ultrasónicas de modo torsional.
2.
Herramienta según la reivindicación 1, en la que el elemento operativo está curvado en un plano sustancialmente perpendicular al de los medios de arista.
3.
Herramienta según la reivindicación 1 ó 2, en la que el elemento operativo es de sección decreciente hacia su extremo distal.
4.
Herramienta según cualquiera de las reivindicaciones anteriores, en la que el elemento operativo presenta una punta distal sustancialmente roma.
5.
Herramienta según cualquiera de las reivindicaciones anteriores, en la que el elemento operativo comprende dos caras convergentes que se extienden transversalmente con respecto al plano de curvatura del elemento operativo, siendo preferentemente dicha primera cara convergente curvada de manera cóncava y dicha segunda cara convergente de manera convexa.
6.
Herramienta según la reivindicación 5, en la que los medios de arista se extienden en un plano que generalmente bisecciona los de las caras convergentes, y la primera cara convergente cóncava converge hacia el plano de los medios de arista más gradualmente que la segunda cara convergente convexa.
7.
Herramienta según cualquiera de las reivindicaciones anteriores, en la que el elemento operativo comprende además un elemento de mordaza giratorio que puede desplazarse de manera controlable pivotando en el acoplamiento y desacoplamiento con los medios de arista.
8.
Herramienta según la reivindicación 7, en la que el elemento de mordaza o su superficie de contacto está curvado de manera correspondiente con los medios de arista.
9.
Herramienta según cualquiera de las reivindicaciones anteriores, que comprende además unos medios según los cuales puede hacerse girar el elemento operativo de manera seleccionable alrededor de un eje longitudinal de la guía de ondas para que se presente ante un elemento de tejido deseado sobre la cual debe actuar.
10.
Herramienta según la reivindicación 7, en la que el elemento de mordaza presenta una curvatura que corresponde con la de los medios de arista, pudiéndose accionar dicho elemento de mordaza para que entre en contacto con una superficie superior de los medios de arista y atrapar el tejido que debe cortarse y coagularse entre los mismos.
ES06709922T 2005-03-03 2006-02-28 Herramienta de corte ultrasónica. Expired - Lifetime ES2356757T3 (es)

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GB0504321 2005-03-03
GB0504321A GB2423931B (en) 2005-03-03 2005-03-03 Ultrasonic cutting tool

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EP (1) EP1916950B1 (es)
AT (1) ATE493943T1 (es)
DE (1) DE602006019440D1 (es)
ES (1) ES2356757T3 (es)
GB (1) GB2423931B (es)
WO (1) WO2006092576A1 (es)

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US9387004B2 (en) 2016-07-12
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US20130238004A1 (en) 2013-09-12
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