ES2602110T3 - Instrumentos quirúrgicos mejorados - Google Patents

Instrumentos quirúrgicos mejorados Download PDF

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ES2602110T3
ES2602110T3 ES11175923.9T ES11175923T ES2602110T3 ES 2602110 T3 ES2602110 T3 ES 2602110T3 ES 11175923 T ES11175923 T ES 11175923T ES 2602110 T3 ES2602110 T3 ES 2602110T3
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terminal effector
tissue
frequency
transducer
effector
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Eitan T. Wiener
Kenneth S. Kramer
Foster B. Stulen
Ashvani K. Madan
Kevin L. Houser
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Ethicon Endo Surgery LLC
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Ethicon Endo Surgery LLC
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N7/02—Localised ultrasound hyperthermia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00084—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00106—Sensing or detecting at the treatment site ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00115—Electrical control of surgical instruments with audible or visual output
    • A61B2017/00128—Electrical control of surgical instruments with audible or visual output related to intensity or progress of surgical action
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00353—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery one mechanical instrument performing multiple functions, e.g. cutting and grasping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320071—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with articulating means for working tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320089—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic node location
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A61B2017/320094—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw additional movable means performing clamping operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A61B2017/320095—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw with sealing or cauterizing means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00607—Coagulation and cutting with the same instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature

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Abstract

Un dispositivo quirúrgico que comprende: un transductor (40, 1006, 1306) para recibir una señal eléctrica de un generador (30, 1004, 1304) a una frecuencia de activación, el transductor (40, 1006, 1306) para proporcionar vibraciones a la frecuencia de activación; y un efector terminal (180, 1008, 1308) acoplado con el transductor (40, 1006, 1306) y que se extiende desde el transductor (40, 1006, 1306) a lo largo de un eje longitudinal; y caracterizado por un circuito de control (1002, 1302) configurado para: detectar un cambio en una frecuencia de vibración del efector terminal (180, 1008, 1308) y para identificar como un resultado una condición de tejido en contacto con el efector terminal (180, 1008, 1308); y para generar una señal que indica la existencia de esa condición; y medios sensibles a la señal para indicar la condición a un practicante clínico.

Description

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DESCRIPCION
Instrumentos quirurgicos mejorados ANTECEDENTES
Los instrumentos ultrasonicos, incluyendo los instrumentos tanto de nucleo hueco como de nucleo macizo, son utilizados para el tratamiento seguro y eficaz de muchas afecciones medicas. Los instrumentos ultrasonicos son ventajosos porque pueden ser utilizados para cortar y/o coagular tejido organico utilizando energfa en forma de vibraciones mecanicas transmitidas a un efector terminal quirurgico a frecuencias ultrasonicas. Las vibraciones ultrasonicas, cuando son transmitidas al tejido organico a niveles adecuados de energfa y utilizando un efector terminal adecuado, pueden ser utilizadas para cortar, disecar, elevar o cauterizar tejido o para separar tejido muscular del hueso. Tales instrumentos pueden ser utilizados para procedimientos abiertos o procedimientos mfnimamente invasivos, tales como procedimientos endoscopicos o laparoscopicos, en los que se pasa el efector terminal a traves de un trocar para alcanzar el sitio quirurgico.
La activacion o excitacion del efector terminal (por ejemplo, hoja de corte) de tales instrumentos a frecuencias ultrasonicas induce un movimiento vibratorio longitudinal que genera calor localizado en el tejido adyacente, facilitando tanto el corte como la coagulacion. Debido a la naturaleza de los instrumentos ultrasonicos, se puede disenar un efector terminal particular accionado ultrasonicamente para llevar a cabo numerosas funciones, incluyendo, por ejemplo, el corte y la coagulacion.
La vibracion ultrasonica es inducida en el efector terminal quirurgico al excitar electricamente un transductor, por ejemplo. El transductor puede estar construido de uno o mas elementos piezoelectricos o magnetoestrictivos en la empunadura del instrumento. Las vibraciones generadas por la seccion del transductor son transmitidas al efector terminal quirurgico por medio de un guiaondas ultrasonico que se extiende desde la seccion del transductor hasta el efector terminal quirurgico. Los guiaondas y los efectores terminales estan disenados para resonar a la misma frecuencia que el transductor. Por lo tanto, cuando un efector terminal esta fijado a un transductor la frecuencia del sistema en su conjunto es la misma frecuencia que la del propio transductor.
La amplitud de cero a pico de la vibracion ultrasonica longitudinal en la punta, d, del efector terminal se comporta como una sinusoide sencilla en la frecuencia resonante dada por:
d = Asen(Dt)
en la que:
o = la frecuencia angular, que es igual a 2% veces la frecuencia cfclica, f; y A = la amplitud de cero a pico.
La carrera longitudinal esta definida como la amplitud de pico a pico (p-t-p), que es justo el doble de la amplitud de la onda sinusoidal o 2A.
Los instrumentos quirurgicos ultrasonicos pueden ser divididos en dos tipos, dispositivos de efector terminal de un unico elemento y dispositivos de efector terminal de multiples elementos. Los dispositivos de efector terminal de un unico elemento incluyen instrumentos tales como bisturfs y coaguladores esfericos. Los instrumentos de efector terminal de un unico elemento tienen una capacidad limitada para aplicar una presion entre la hoja y el tejido cuando el tejido es blando y esta soportado sin apretar. A veces, puede ser necesaria una presion sustancial para acoplar de forma eficaz la energfa ultrasonica al tejido. Esta incapacidad para agarrar el tejido tiene como resultado una incapacidad adicional para coaptar completamente superficies de tejido mientras que se aplica una energfa ultrasonica, lo que da lugar a una union del tejido y a una hemostasia inferiores a las deseadas. En estos casos, se pueden utilizar efectores terminales de multiples elementos. Los dispositivos de efector terminal de multiples elementos, tales como coaguladores de apriete, incluyen un mecanismo para presionar tejido contra una hoja ultrasonica que puede superar estos defectos.
Aunque los instrumentos quirurgicos ultrasonicos son utilizados de forma generalizada en muchas aplicaciones quirurgicas, su utilidad esta limitada por su incapacidad para reaccionar a condiciones del tejido y del efector terminal. Por ejemplo, segun se utiliza el efector terminal de un instrumento ultrasonico para coagular y/o cortar tejido, se calienta a menudo. Esto puede provocar incoherencias en el rendimiento del instrumento. Ademas, no existe forma de que un clfnico que utilice el instrumento sepa cuando el instrumento ha comenzado a coagular el tejido, cuando el instrumento ha comenzado a cortar tejido, o cualquier otra informacion acerca del tejido.
Otro conjunto de inconvenientes de los instrumentos ultrasonicos surge de los disenos existentes de efectores terminales. En los disenos existentes, solo la punta del efector terminal (por ejemplo, la hoja) es ultrasonicamente activa. En consecuencia, puede que el tejido que hace contacto con la hoja mas de una fraccion de una longitud de onda desde la punta no se vea afectado en absoluto. Ademas, debido a que las ondas deben
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propagarse desde el transductor hasta la punta del efector terminal, los efectores terminales existentes no son muy flexibles, limitando por consiguiente su capacidad para articular y limitar su utilidad en aplicaciones quirurgicas laparoscopicas y endoscopicas.
En el documento EP 1 199 045 se da a conocer un metodo para diferenciar entre hojas sintonizadas ultrasonicamente que estan rotas o agrietadas y hojas que estan mugrientas evaluando las diferencias de impedancia medidas cuando se excita un sistema con una senal de desplazamiento baja y con una senal de desplazamiento alta. Tambien puede detectarse la presencia de desechos por mediciones de impedancia
RESUMEN
La presente invencion proporciona un dispositivo quirurgico como se reivindica en la reivindicacion 1 anadida. El dispositivo quirurgico comprende un transductor, y un efector, un generador y un circuito de control. El transductor esta configurado para proporcionar vibraciones. El efector terminal esta acoplado con el transductor y se extiende desde el transductor a lo largo del eje longitudinal. El generador esta configurado para proporcionar una senal electrica al transductor.
En otro aspecto general, las diversas realizaciones estan dirigidas a un instrumento quirurgico que comprende un transductor, un mecanismo de apriete y un circuito de control. El transductor puede estar configurado para proporcionar vibraciones. El efector terminal puede estar acoplado con el transductor y puede extenderse desde el transductor a lo largo del eje longitudinal. El mecanismo de apriete puede ser trasladable hacia el efector terminal. El circuito de control puede calcular una curva que representa un coeficiente de desnaturalizacion de colageno a traves del tiempo. El coeficiente de desnaturalizacion de colageno puede calcularse considerando: un polvo administrado por el efector terminal a una porcion del tejido; una fuerza de apriete aplicada a la porcion del tejido entre el efector terminal y el mecanismo de apriete; un desplazamiento del efector terminal; y una frecuencia de vibracion del efector terminal. De acuerdo con varias realizaciones, el circuito de control puede tambien identificar un primer cambio en una pendiente de la curva desde una pendiente sustancialmente negativa a una pendiente sustancialmente neutra e indicar un comienzo de coagulacion de tejido en respuesta al primer cambio. Tambien, de acuerdo con varias realizaciones, el circuito de control puede identificar una primera region de la curva que tiene una pendiente sustancialmente constante. El circuito de control puede calcular una propiedad de la region que describe la primera region y derivar una propiedad del tejido de la porcion de tejido en contacto con el efector terminal.
En otro aspecto general, las varias realizaciones estan dirigidas a un dispositivo quirurgico que comprende un efector terminal. El efector terminal puede comprender un miembro central que se extiende longitudinalmente a traves del efector terminal y una pluralidad de transductores de modo radial. Los transductores de modo radial pueden estar posicionados alrededor del miembro central, y pueden configurarse para responder a una senal electrica vibrando en una direccion perpendicular al eje longitudinal. Las ondas estacionarias pueden ser ultrasonicas.
FIGURAS
Las caracterfsticas novedosas de las diversas realizaciones se definen con particularidad en las reivindicaciones adjuntas. Sin embargo, se pueden comprender mejor las diversas realizaciones, tanto en cuanto a la organizacion como en cuanto a los procedimientos de operacion, junto con objetos y ventajas adicionales de las mismas, por referencia a la siguiente descripcion, tomada en conjunto con los dibujos adjuntos como siguen.
La FIG. 1 ilustra una realizacion de un sistema quirurgico que incluye un instrumento quirurgico y un generador ultrasonico.
La FIG. 2 ilustra una realizacion del instrumento quirurgico mostrado en la FIG. 1.
La FIG. 3 ilustra una vista despiezada de una realizacion del instrumento quirurgico mostrado en la FIG. 1.
La FIG. 4 ilustra una realizacion de un mecanismo de apriete que puede ser utilizado con el instrumento quirurgico mostrado en la FIG. 1.
La FIG. 5 ilustra una vista recortada de una realizacion del instrumento quirurgico mostrado en la FIG. 1.
La FIG. 6 ilustra diversos componentes internos de una realizacion del instrumento quirurgico mostrado en la FIG. 1.
La FIG. 7 ilustra una realizacion de un yugo de accionamiento del instrumento quirurgico mostrado en la FIG. 1.
La FIG. 8 ilustra una realizacion de un collar de accionamiento del instrumento quirurgico mostrado en la FIG. 1.
La FIG. 9 ilustra una realizacion de un sistema quirurgico que incluye un instrumento quirurgico que tiene un efector terminal de un unico elemento.
La FIG. 10 ilustra un diagrama de bloques de una realizacion de un dispositivo quirurgico.
La FIG. 11 muestra un grafico que ilustra los resultados de una prueba ejemplar de un dispositivo quirurgico. La FIG. 12 muestra un grafico que ilustra una relacion entre la frecuencia del efector terminal y la temperatura del efector terminal.
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La FIG. 13 ilustra un diagrama de bloques de una realizacion de un dispositivo quirurgico.
La FIG. 14 muestra un grafico que ilustra un coeficiente de curva de desnaturalizacion del colageno.
La FIG. 15 muestra un grafico que ilustra un coeficiente de curva de desnaturalizacion del colageno.
La FIG. 16 muestra una serie de curvas que ilustran relaciones entre un valor normalizado de una primera region de un coeficiente de curva de desnaturalizacion del colageno y la fuerza de apriete, nivel de potencia, diametro externo y grosor de la pared.
La FIG. 17 ilustra una realizacion de un efector terminal para un dispositivo quirurgico que incluye transductores de modo radial.
La FIG. 18 ilustra una realizacion del efector terminal de la FIG. 17 instalado en un instrumento quirurgico que incluye un brazo de apriete.
La FIG. 19 ilustra una realizacion del efector terminal de la FIG. 17 que incluye un miembro central flexible.
La FIG. 20 ilustra una realizacion del efector terminal de la FIG. 17 que incluye un transductor que define una
concavidad.
La FIG. 21 ilustra una realizacion del efector terminal de la FIG. 20.
DESCRIPCION
Antes de explicar las diversas realizaciones con detalle, se deberfa hacer notar que las realizaciones no estan limitadas en aplicacion o uso a los detalles de construccion y a la disposicion de las piezas ilustradas en los dibujos adjuntos y en la descripcion. Las realizaciones ilustrativas pueden ser implementadas o incorporadas en otras realizaciones, variaciones y modificaciones, y pueden ser puestas en practica o llevadas a cabo de diversas formas. Por ejemplo, las configuraciones de los instrumentos quirurgicos y de la hoja dadas a continuacion son unicamente ilustrativas y no se pretende que limiten el alcance ni la aplicacion de los mismos. Ademas, los disenos de la hoja y del efector terminal descritos a continuacion en el presente documento pueden ser utilizados junto con cualquier dispositivo adecuado. Ademas, a no ser que se indique lo contrario, los terminos y expresiones empleados en el presente documento han sido escogidos con el fin de describir las realizaciones ilustrativas para la comodidad del lector y no para limitar el alcance del presente documento.
En las patentes U.S. nos 5.322.055 y 5.954.736, 6.309.400 B2, 6.278.218 B1, 6.283.981 B1 y 6.325.811 B1 se dan a conocer ejemplos de instrumentos y hojas quirurgicas ultrasonicas. Estas referencias dan a conocer disenos de instrumentos quirurgicos ultrasonicos y disenos de hojas en los que se excita un modo longitudinal de la hoja. El resultado es una onda estacionaria longitudinal en el instrumento. En consecuencia, el instrumento tiene nodos, en los que el movimiento transversal es igual a cero, y antinodos, en los que el movimiento transversal se encuentra en su maximo. A menudo, el efector terminal de tejido del instrumento esta colocado en un antinodo para maximizar su movimiento longitudinal.
Se describiran ahora diversas realizaciones para proporcionar una comprension general de los principios de la estructura, la funcion, la fabricacion, y el uso de los dispositivos y de los procedimientos dados a conocer en el presente documento. En los dibujos adjuntos se ilustran uno o mas ejemplos de estas realizaciones. Las personas con un nivel normal de dominio de la tecnica comprenderan que los dispositivos y los procedimientos descritos especfficamente en el presente documento e ilustrados en los dibujos adjuntos son realizaciones no limitantes y que el alcance de las diversas realizaciones solo esta definido por las reivindicaciones. Las caracterfsticas ilustradas o descritas en conexion con una realizacion pueden combinarse con las caracterfsticas de otras realizaciones. Se pretende que tales modificaciones y variaciones esten incluidas dentro del alcance de las reivindicaciones.
Se apreciara que en el presente documento los terminos “proximal” y “distal” se utilizan con referencia a un clfnico que agarra un dispositivo quirurgico en su conjunto de empunadura, u otra pieza comparable. Por lo tanto, el efector terminal es distal con respecto al conjunto de empunadura mas proximal. Ademas, se apreciara que, en aras de la conveniencia y de la claridad, tambien se utilizan en el presente documento terminos espaciales tales como “superior” e “inferior” con respecto al clmico que agarra el conjunto de empunadura, o pieza comparable. Sin embargo, se utilizan instrumentos quirurgicos en muchas orientaciones y posiciones, y no se pretende que estos terminos sean limitantes ni absolutos.
La FIG. 1 ilustra una realizacion de un sistema quirurgico que incluye un instrumento quirurgico y un generador ultrasonico. La FIG. 2 ilustra una realizacion del aparato mostrado en la FIG. 1. En la realizacion ilustrada en las FIGURAS 1-2, el sistema quirurgico 10 incluye un instrumento ultrasonico coagulador 120 de apriete y un generador ultrasonico 30. El instrumento quirurgico 120 incluye una unidad 50 de accionamiento ultrasonico. Como se describira adicionalmente, un transductor ultrasonico de la unidad 50 de accionamiento, y un efector terminal ultrasonico 180 del instrumento 120 de apriete proporcionan conjuntamente un conjunto acustico del sistema quirurgico 10, proporcionando el conjunto acustico energfa ultrasonica para procedimientos quirurgicos cuando es alimentado por el generador 30. Se debe hacer notar que, en algunas aplicaciones, la unidad 50 de accionamiento ultrasonico es denominada “conjunto de empunadura” debido a que el instrumento quirurgico 120 del sistema quirurgico 10 esta configurado de forma que un clfnico agarra y manipula la unidad 50 de accionamiento ultrasonico durante diversos procedimientos y operaciones. El instrumento 120 puede incluir una disposicion de agarre similar a la de unas tijeras, lo que facilita la colocacion y la manipulacion del instrumento 120 ademas de la manipulacion de la
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unidad 50 de accionamiento ultrasonico.
El generador 30 del sistema quirurgico 10 envfa una senal electrica a traves de un cable 32 en una carrera, una frecuencia y una fase seleccionadas determinadas por un sistema de control del generador 30. Como se describira adicionalmente, la senal provoca que uno o mas elementos piezoelectricos del conjunto acustico del instrumento quirurgico 120 se expandan y contraigan a lo largo de un eje longitudinal, convirtiendo de ese modo la energfa electrica en movimiento mecanico. El movimiento mecanico tiene como resultado ondas longitudinales de energfa ultrasonica que se propagan a traves del conjunto acustico en una onda estacionaria acustica para hacer vibrar el conjunto acustico con una frecuencia y una carrera seleccionadas. Se coloca el efector terminal 180 en contacto con el tejido del paciente para transmitir la energfa ultrasonica al tejido. Por ejemplo, se puede poner una porcion distal de la hoja 180' del efector terminal en contacto con el tejido. Como se describe adicionalmente a continuacion, se puede utilizar una herramienta quirurgica, tal como, un mecanismo de mordaza o de apriete, para presionar el tejido contra la hoja 180'.
Segun se acopla el efector terminal 180 con el tejido, se genera energfa termica o calor como resultado del rozamiento, de la absorcion acustica, y de perdidas viscosas en el tejido. El calor es suficiente para romper enlaces protefnicos de hidrogeno, haciendo que la protefna altamente estructurada (por ejemplo, colageno y protefna muscular) se desnaturalice (por ejemplo, se vuelva menos organizada). Segun se desnaturalizan las protefnas, se forma un coagulo viscoso para sellar o coagular vasos sangufneos pequenos. Se obtiene una coagulacion profunda de vasos sangufneos mayores cuando se prolonga el efecto.
La transferencia de la energfa ultrasonica al tejido provoca otros efectos incluyendo desgarro mecanico, corte, cavitacion, disrupcion celular, y emulsificacion. La cantidad de corte, al igual que el grado de coagulacion obtenido, varfa con la carrera del efector terminal 180, la frecuencia de vibracion, la cantidad de presion aplicada por el usuario, lo afilado del efector terminal 180, y el acoplamiento entre el efector terminal 180 y el tejido.
En la realizacion ilustrada en la FIG. 1, el generador 30 incluye un sistema de control integral con el generador 30, un interruptor 34 de alimentacion, y un mecanismo 36 de activacion. El interruptor 34 de alimentacion controla la energfa electrica al generador 30, y cuando esta activado por el mecanismo 36 de activacion, el generador 30 proporciona energfa para accionar el conjunto acustico de frecuencia del sistema quirurgico 10 y para accionar el efector terminal 180 con un nivel predeterminado de carrera. El generador 30 acciona o excita el conjunto acustico a cualquier frecuencia resonante adecuada del conjunto acustico.
Cuando se activa el generador 30 por medio del mecanismo 36 de activacion, se aplica continuamente energfa electrica por medio del generador 30 a un conjunto o pila 40 de transductores del conjunto acustico. Un bucle bloqueado por fase en el sistema de control del generador 30 monitoriza la realimentacion del conjunto acustico. El bucle bloqueado por fase ajusta la frecuencia de la energfa electrica enviada por el generador 30 para igualar la frecuencia resonante del modo longitudinal seleccionado de vibracion del conjunto acustico. Ademas, un segundo bucle de realimentacion en el sistema de control mantiene la corriente electrica suministrada al conjunto acustico en un nivel constante preseleccionado para conseguir una carrera sustancialmente constante en el efector terminal 180 del conjunto acustico.
La senal electrica suministrada al conjunto acustico provocara que el extremo distal del efector terminal 180, por ejemplo, la hoja 180', vibre longitudinalmente en el intervalo, por ejemplo, aproximadamente desde 20 kHz hasta 250 kHz. Segun diversas realizaciones, la hoja 180' puede vibrar en el intervalo desde aproximadamente 54 kHz hasta 56 kHz, por ejemplo, a aproximadamente 55,5 kHz. En otras realizaciones, la hoja 180' puede vibrar a otras frecuencias incluyendo, por ejemplo, aproximadamente 31 kHz o aproximadamente 80 kHz. Se puede controlar la carrera de las vibraciones en la hoja, por ejemplo, al controlar la amplitud de la senal electrica aplicada al conjunto 40 de transductores del conjunto acustico por medio del generador 30.
Como se ha hecho notar anteriormente, el mecanismo 36 de activacion del generador 30 permite que un usuario active el generador 30, de forma que se pueda suministrar continuamente energfa electrica al conjunto acustico. El mecanismo 36 de activacion puede comprender un interruptor de activacion de pedal que esta acoplado o fijado de forma desmontable al generador 30 por medio de un cable o conductor flexible. De forma alternativa, el mecanismo de activacion puede estar configurado como un interruptor de mano incorporado en la unidad 50 de accionamiento ultrasonico para permitir que el generador 30 sea activado por un usuario.
El generador 30 tambien tiene una lfnea 38 de alimentacion para su insercion en una unidad electroquirurgica o en un enchufe electrico convencional. Se contempla que el generador 30 tambien pueda estar alimentado por una fuente de corriente continua (CC), tal como una baterfa. El generador 30 puede comprender cualquier generador adecuado, tal como el modelo n° GEN04, disponible en Ethicon Endo Surgery, Inc.
En la realizacion ilustrada en las FIGURAS 1 y 3, la unidad quirurgica 50 de accionamiento del instrumento quirurgico incluye un alojamiento 52 de multiples piezas adaptado para aislar al operario de las vibraciones del conjunto acustico. El alojamiento 52 de la unidad de accionamiento puede estar formado para ser sujetado por un
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usuario de forma convencional, pero se contempla que el presente instrumento coagulador 120 de apriete sea agarrado y manipulado principalmente por medio de una disposicion similar a la de unas tijeras proporcionada por un alojamiento del aparato, como se describira. Aunque se ilustra el alojamiento 52 de multiples piezas, el alojamiento 52 puede comprender un componente unico o unitario.
El alojamiento 52 de la unidad 50 de accionamiento ultrasonico incluye, en general, un extremo proximal, un extremo distal, y una cavidad que se extiende longitudinalmente en el mismo. El extremo distal del alojamiento 52 incluye una abertura 60 configurada para permitir que el conjunto acustico del sistema quirurgico 10 se extienda a traves de la misma, y el extremo proximal del alojamiento 52 esta acoplado al generador 32 por medio del cable 32. El cable 32 puede incluir conductos o respiraderos 62 para permitir que se introduzca aire u otros fluidos en el alojamiento 52 de la unidad 50 de accionamiento ultrasonico para enfriar el conjunto 40 de transductores del conjunto acustico.
El alojamiento 52 de la unidad 50 de accionamiento ultrasonico puede estar construido a partir de un plastico resistente, tal como ULTEM®. Tambien se contempla que el alojamiento 52 pueda estar fabricado, de forma alterna, de una variedad de materiales incluyendo otros plasticos (por ejemplo, polfmero de cristal lfquido (LCP), nailon, o policarbonato) y/o metales (por ejemplo, aluminio, acero, etc.). Una unidad 50 de accionamiento ultrasonico es el modelo n° HP054, disponible en Ethicon Endo Surgery, Inc.
El conjunto acustico del instrumento quirurgico incluye una primera porcion acustica y una segunda porcion acustica. La primera porcion acustica puede ser portada por la unidad 50 de accionamiento ultrasonico, y la segunda porcion acustica (en forma de un efector terminal 180, como se describira) es portada por el coagulador ultrasonico 120 de apriete. El extremo distal de la primera porcion acustica esta acoplado de forma operativa al extremo proximal de la segunda porcion acustica, preferentemente por medio de una conexion roscada.
En la realizacion ilustrada en la FIG. 2, la primera porcion acustica incluye el conjunto o pila 40 de transductores y un dispositivo 84 de montaje, y la segunda porcion acustica incluye el efector terminal 180. El efector terminal 180 puede comprender, a su vez, un componente de transmision, o guiaondas 181 (FIG. 3), al igual que una porcion distal, u hoja 180', para hacer contacto con el tejido.
Los componentes del conjunto acustico pueden estar sintonizados acusticamente, de forma que la longitud de cada componente sea un numero entero de la mitad de las longitudes de onda (nX/2), siendo la longitud de onda X la longitud de onda de una frecuencia de vibracion longitudinal operativa o preseleccionada fo del conjunto acustico, y n es cualquier numero entero no negativo. Tambien se contempla que el conjunto acustico puede incorporar cualquier disposicion adecuada de elementos acusticos.
El conjunto 40 de transductores del conjunto acustico convierte la senal electrica procedente del generador 30 en energfa mecanica que tiene como resultado un movimiento vibratorio longitudinal del efector terminal 180 a frecuencias ultrasonicas. Cuando se energiza el conjunto acustico, se genera una onda estacionaria de movimiento vibratorio a traves del conjunto acustico. La carrera del movimiento vibratorio en cualquier punto a lo largo del conjunto acustico depende de la ubicacion a lo largo del conjunto acustico en el que se mide el movimiento vibratorio. Un cruce mfnimo o nulo en la onda estacionaria de movimiento vibratorio es denominado, en general, un nodo (por ejemplo, cuando el movimiento es normalmente mfnimo), y un valor absoluto local maximo o pico en la onda estacionaria es denominado, en general, antinodo. La distancia entre un antinodo y su nodo mas cercano es un cuarto de la longitud de onda (X/4).
En la realizacion ilustrada en la FIG. 2, el conjunto de transductores del conjunto acustico, que es tambien conocido como una “pila de Langevin”, incluye, en general, una porcion 90 de transduccion, un primer resonador 92, y un segundo resonador 94. El conjunto 40 de transductores puede tener una longitud de un numero entero de semilongitudes de onda (nX/2) del sistema. Se debe comprender que otras realizaciones del conjunto 40 de transductores pueden comprender un transductor magnetoestrictivo, electromagnetico o electrostatico.
El extremo distal del primer resonador 92 esta conectado al extremo proximal de la seccion 90 de transduccion, y el extremo proximal del segundo resonador 94 esta conectado al extremo distal de la porcion 90 de transduccion. Los resonadores primero y segundo 92 y 94 pueden estar fabricados de titanio, aluminio, acero, o cualquier otro material adecuado, y mas preferentemente, el primer resonador 92 esta fabricado de acero inoxidable 303 y el segundo resonador 94 esta fabricado de aluminio 7075-T651. Los resonadores primero y segundo 92 y 94 tienen una longitud determinada por un numero de variables, incluyendo la longitud de la seccion 90 de transduccion, la velocidad del sonido en el material utilizado en los resonadores 92 y 94, y la frecuencia fundamental deseada f0 del conjunto 40 de transductores. El segundo resonador 94 puede estar ahusado hacia dentro desde su extremo proximal hasta su extremo distal para funcionar como un transformador de velocidad y amplificar la carrera de la vibracion ultrasonica.
La porcion 90 de transduccion del conjunto 40 de transductores puede comprender una seccion piezoelectrica de electrodos positivos 96 y electrodos negativos 98 alternantes, con los elementos piezoelectricos
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100 alternantes entre los electrodos 96 y 98. Los elementos piezoelectricos 100 pueden estar fabricados de cualquier material adecuado, tal como, por ejemplo, titanato y zirconato de plomo, metaniobato de plomo, titanato de plomo, u otro material piezoelectrico. Cada uno de los electrodos positivos 96, de los electrodos negativos 98, y de los elementos piezoelectricos 100 tiene un orificio que se extiende a traves del centro. Los electrodos positivos y negativos 96 y 98 estan acoplados electricamente a hilos 102, y 104, respectivamente. Los hilos 102 y 104 transmiten la senal electrica desde el generador 30 hasta los electrodos 96 y 98.
Los elementos piezoelectricos 100 pueden ser mantenidos en compresion entre los resonadores primero y segundo 92 y 94 por medio de un tornillo 106. El tornillo 106 puede tener una cabeza, un cuerpo, y un extremo distal roscado. El tornillo 106 puede ser insertado desde el extremo proximal del primer resonador 92 a traves de los orificios del primer resonador 92, de los electrodos 96 y 98, y de los elementos piezoelectricos 100. El extremo distal roscado del tornillo 106 es atornillado en un orificio roscado en el extremo proximal del segundo resonador 94. El tornillo 106 puede estar fabricado de acero, titanio, aluminio, u otro material adecuado. Por ejemplo, el tornillo 106 puede estar fabricado de titanio Ti-6A1-4V, o de acero bajo en carbono aleado 4037.
Los elementos piezoelectricos 100 pueden ser energizados en respuesta a la senal electrica suministrada desde el generador 30 para producir una onda estacionaria acustica en el conjunto acustico. La senal electrica provoca un campo electromagnetico a traves de los elementos piezoelectricos 100, provocando que los elementos piezoelectricos 100 se expandan y contraigan de forma continua a lo largo del eje longitudinal del gradiente de tension, produciendo ondas longitudinales de alta frecuencia de energfa ultrasonica. La energfa ultrasonica es transmitida al efector terminal 180 a traves del conjunto acustico.
El dispositivo 84 de montaje del conjunto acustico tiene un extremo proximal, un extremo distal, y puede tener una longitud sustancialmente igual a un numero entero de semilongitudes de onda (nX/2) del sistema. El extremo proximal del dispositivo 84 de montaje puede estar alineado de forma axial y acoplado al extremo distal del segundo resonador 94 por medio de una conexion roscada interna cerca de un antinodo. Tambien se contempla que el dispositivo 84 de montaje puede estar fijado al segundo resonador 94 mediante cualquier medio adecuado, y el segundo resonador 94 y el dispositivo 84 de montaje pueden estar formados como un componente unico o unitario.
El dispositivo 84 de montaje esta acoplado al alojamiento 52 de la unidad 50 de accionamiento ultrasonico cerca de un nodo. El dispositivo 84 de montaje puede incluir un reborde integral 108 de montaje dispuesto en torno a su periferia. El reborde 108 de montaje puede estar dispuesto en una muesca anular 110 formada en el alojamiento 52 de la unidad 50 de accionamiento ultrasonico para acoplar el dispositivo 84 de montaje al alojamiento 52. Puede haber colocado un miembro o material compatible 112, tal como un par de juntas toricas de caucho de silicona fijadas por medio de separadores, entre la muesca anular 110 del alojamiento 52 y el reborde integral 108 del dispositivo 86 de montaje para reducir la transmision de una vibracion ultrasonica, o evitar que se transmita la misma, desde el dispositivo 84 de montaje al alojamiento 52.
El dispositivo 84 de montaje puede estar fijado en una posicion axial predeterminada por medio de una pluralidad de pasadores 114, por ejemplo, cuatro. Los pasadores 114 estan dispuestos en una direccion longitudinal separados noventa (90) grados entre si en torno a la periferia externa del dispositivo 84 de montaje. Los pasadores 114 estan acoplados al alojamiento 52 de la unidad 50 de accionamiento ultrasonico y estan dispuestos a traves de cortes en el reborde acustico 108 de montaje del dispositivo 84 de montaje. Los pasadores 114 pueden estar fabricados de acero inoxidable. Segun diversas realizaciones, los pasadores 114 pueden estar formados como componentes integrales del alojamiento 52.
El dispositivo 84 de montaje puede estar configurado para amplificar la carrera de la vibracion ultrasonica que es transmitida a traves del conjunto acustico hasta el extremo distal del efector terminal 180. En una realizacion, el dispositivo 84 de montaje comprende una bocina ahusada maciza. Segun se transmite energfa ultrasonica a traves del dispositivo 84 de montaje, se amplifica la velocidad de la onda acustica transmitida a traves del dispositivo 84 de montaje. Se contempla que el dispositivo 84 de montaje este configurado como cualquier forma adecuada, tal como, por ejemplo, una bocina escalonada, una bocina conica, una bocina exponencial, una bocina de ganancia unitaria, o similar.
El dispositivo 84 de montaje puede estar acoplado acusticamente a la segunda porcion acustica del instrumento coagulador ultrasonico 120 de apriete. El extremo distal del dispositivo 84 de montaje puede estar acoplado al extremo proximal de la segunda porcion acustica por medio de una conexion roscada interna cerca de un antinodo, pero se pueden emplear disposiciones alternativas de acoplamiento.
La FIG. 3 ilustra una vista despiezada de una realizacion del instrumento quirurgico mostrado en la FIG. 1. Preferentemente, el extremo proximal del instrumento coagulador ultrasonico 120 de apriete recibe el extremo distal, y esta encajado en el mismo, de la unidad 50 de accionamiento ultrasonico por medio de la insercion de la unidad 50 de accionamiento en el alojamiento 52, como se muestra en la FIG. 2. El instrumento coagulador ultrasonico 120 de apriete puede estar fijado a la unidad 50 de accionamiento ultrasonico, y puede ser extrafdo de la misma como una unidad. El coagulador ultrasonico 120 de apriete puede ser desechado despues de un unico uso.
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El instrumento coagulador ultrasonico 120 de apriete puede incluir un conjunto de mango o un alojamiento 130, que puede comprender porciones 131, 132 de acoplamiento del alojamiento, y una porcion alargada o endoscopica 150. Cuando el presente aparato esta configurado para un uso endoscopico, la construccion puede estar dimensionada de forma que la porcion 150 tenga un diametro externo de aproximadamente 5,5 mm. La porcion alargada 150 del instrumento coagulador ultrasonico 120 de apriete puede extenderse de forma sustancialmente ortogonal desde el alojamiento 130 del aparato. La porcion alargada 150 puede ser girada de forma selectiva con respecto al alojamiento 130, como se describe a continuacion. La porcion alargada 150 puede incluir un miembro tubular externo o vaina 160, un miembro tubular interno 170 de accionamiento, y la segunda porcion acustica del sistema acustico en forma de un efector terminal 180, incluyendo una hoja 180'. Como se describira, la vaina externa 160, el miembro 170 de accionamiento, y el efector terminal 180 pueden estar unidos entre si para una rotacion indexada como una unidad (junto con la unidad 50 de accionamiento ultrasonico) con respecto al alojamiento 130.
El extremo proximal del efector terminal 180 de la segunda porcion acustica puede estar acoplado de forma desmontable al dispositivo 84 de montaje de la unidad 50 de accionamiento ultrasonico cerca de un antinodo, como se ha descrito anteriormente. El efector terminal 180 puede tener una longitud sustancialmente igual a un numero entero de semilongitudes onda (nX/2) del sistema. El efector terminal 180 puede estar fabricado de un eje de nucleo macizo construido de material que propaga energfa ultrasonica de forma eficaz, tal como una aleacion de titanio (por ejemplo, Ti-6A1-4V) o una aleacion de aluminio. Se contempla que el efector terminal 180 puede estar fabricado, de forma alternativa, de cualquier otro material adecuado.
Como se describe, el efector terminal 180 puede incluir un guiaondas 181. El guiaondas 181 puede ser sustancialmente semiflexible. Se reconocera que, el guiaondas 181 puede ser, de forma alternativa, sustancialmente rfgido o puede comprender un hilo flexible. El guiaondas 181 puede estar configurado para amplificar las vibraciones mecanicas transmitidas a traves del guiaondas a la hoja, como es bien conocido en la tecnica. El guiaondas 181 puede tener, ademas, caracterfsticas para controlar la ganancia de la vibracion longitudinal a lo largo del guiaondas 181 y caracterfsticas para sintonizar el guiaondas a la frecuencia de resonancia del sistema.
Se reconocera que el efector terminal 180 puede tener cualquier dimension adecuada en corte transversal. Por ejemplo, el efector terminal 180 puede tener un corte transversal sustancialmente uniforme o el efector terminal 180 puede estar ahusado en diversas secciones o puede estar ahusado a lo largo de toda su longitud.
Con referencia ahora a la FIG. 3, se muestra que la porcion de guiaondas 181 del efector terminal 180 comprende una primera seccion 182, una segunda seccion 184, y una tercera seccion. La primera seccion 182 puede extenderse de forma distal desde el extremo proximal del efector terminal 180, y tiene una dimension sustancialmente continua en corte transversal. La primera seccion 182 puede incluir al menos un agujero o abertura radial 188 que se extiende diametralmente a traves de la misma, sustancialmente perpendicular al eje del efector terminal 180. La abertura 188 puede estar colocada en un nodo, pero puede ser colocada de otra manera. Se reconocera que la abertura 188 puede tener cualquier profundidad adecuada y puede tener cualquier forma adecuada. La abertura 188 esta configurada para recibir un miembro pasador de conexion que conecta entre si el guiaondas 181, el miembro tubular 170 de accionamiento, y la vaina externa tubular 160 para una rotacion conjunta indexada con respecto al alojamiento 130 del aparato.
La segunda seccion 184 del guiaondas 181 se extiende distalmente desde la primera seccion 182. Preferentemente, la segunda seccion 184 tambien tiene un corte transversal sustancialmente continuo. El diametro de la segunda seccion 184 puede ser menor que el diametro de la primera seccion 182 y mayor que el diametro de la tercera seccion 186. Segun pasa energfa ultrasonica desde la primera seccion 182 del efector terminal 180 hasta la segunda seccion 184, el estrechamiento de la segunda seccion 184 tendra como resultado una mayor amplitud de la energfa ultrasonica que pasa a traves de la misma.
La tercera seccion 186 se extiende distalmente desde el extremo distal de la segunda seccion 184. La tercera seccion 186 tambien tiene un corte transversal sustancialmente continuo. La tercera seccion 186 tambien puede incluir pequenos cambios de diametro a lo largo de su longitud. Segun diversas realizaciones, la transicion desde la segunda seccion 184 hasta la tercera seccion 186 puede colocarse en un antinodo, de forma que el cambio de diametro en la tercera seccion no provoca un aumento en la amplitud de la vibracion.
La tercera seccion 186 puede tener una pluralidad de muescas o cortes (no mostrados) formados en su circunferencia externa. Las muescas pueden estar ubicadas en nodos del efector terminal 180 para actuar como indicadores de alineacion para la instalacion de una vaina de amortiguamiento (no mostrada) y anillos estabilizadores de silicona o soportes compatibles durante la fabricacion. Se puede proporcionar una junta en el nodo mas distal, mas cercano a la hoja 180', para reducir el paso de tejido, sangre u otro material en la region entre el guiaondas y el miembro 170 de accionamiento.
La hoja 180' del efector terminal 180 puede ser integral con el mismo y pueden estar formados como una unica unidad. De forma alternativa, la hoja 180' puede estar conectada por medio de una conexion roscada, o por
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medio de una union soldada. Segun diversas realizaciones, la hoja 180' puede ser mecanicamente afilada o mecanicamente roma. El extremo distal de la hoja 180' esta dispuesto cerca de un antinodo para sintonizar el conjunto acustico a una frecuencia de resonancia preferente fo cuando el conjunto acustico no esta cargado con tejido. Cuando el conjunto de transductores esta energizado, el extremo distal de la hoja 180' esta configurado para moverse longitudinalmente en el intervalo, por ejemplo, de aproximadamente 10-500 micrometros de pico a pico, y preferentemente en el intervalo desde aproximadamente 10 hasta aproximadamente 100 micrometros a una frecuencia de vibracion fo predeterminada.
Segun la realizacion ilustrada, la hoja 180' puede ser cilmdrica para cooperar con el mecanismo de apriete asociado del coagulador 120 de apriete. El efector terminal 180 puede recibir un tratamiento superficial adecuado, como es conocido en la tecnica.
La FIG. 4 ilustra una realizacion de un mecanismo de apriete que puede ser utilizado con el instrumento quirurgico mostrado en la FIG. 1. El mecanismo de apriete puede estar configurado para una accion cooperativa con la hoja 180' del efector terminal 180. El mecanismo de apriete incluye un brazo 190 de apriete amovible de forma pivotante, que esta conectado de forma pivotante en el extremo distal del mismo al extremo distal de la vaina tubular externa 160. El brazo 190 de apriete incluye una almohadilla 192 del brazo de apriete del tejido, formado preferentemente de TEFLON® u otro material adecuado de bajo rozamiento, que esta montado para cooperar con la hoja 180', colocando con un movimiento pivotante del brazo 190 de apriete la almohadilla 192 de apriete en una relacion sustancialmente paralela a la hoja 180', y en contacto con la misma. Mediante esta construccion, el tejido que va a ser apretado es agarrado entre la almohadilla 192 del tejido y la hoja 180'. La almohadilla 192 del tejido puede estar dotado de una configuracion similar a dientes de sierra que incluye una pluralidad de dientes 197 de agarre separados axialmente que se extienden de forma proximal para mejorar el agarre del tejido en cooperacion con la hoja 180'.
El movimiento pivotante del brazo 190 de apriete con respecto a la hoja 180' es efectuado por la provision de al menos una porcion 193 de palanca, y preferentemente un par de ellas, del brazo 190 de apriete en el extremo proximal del mismo. Las porciones 193 de palanca estan colocadas en lados opuestos respectivos del efector terminal 180 y de la hoja 180', y estan acopladas de forma operativa con una porcion 194 d e accionamiento del miembro 170 de accionamiento de vaiven. El movimiento de vaiven del miembro 170 de accionamiento, con respecto a la vaina tubular externa 160 y al efector terminal 180, efectua de ese modo un movimiento pivotante del brazo 190 de apriete con respecto a la hoja 180'. Las porciones 193 de palanca pueden ser colocadas respectivamente en un par de aberturas definidas por la porcion 194 de accionamiento, o pueden estar acopladas mecanicamente, si no, de forma adecuada con la misma, por lo que un movimiento recfproco del miembro 170 de accionamiento actua a traves de la porcion 194 de accionamiento y de las porciones 193 de palanca para pivotar el brazo 190 de apriete.
La FIG. 5 ilustra una vista recortada de una realizacion del instrumento quirurgico mostrado en la FIG. 1, mientras que la FIG. 6 ilustra diversos componentes internos de una realizacion del instrumento quirurgico mostrado en la FIG. 1. La FIG. 7 ilustra una realizacion de un yugo de accionamiento, y la FIG. 8 ilustra una realizacion de un collar de accionamiento del instrumento quirurgico mostrado en la FIG. 1. En la realizacion ilustrada en las FIGURAS 3 y 5-8, se efectua un movimiento recfproco del miembro 170 de accionamiento por medio de la provision de un collar 200 de accionamiento montado en el extremo proximal del miembro 170 de accionamiento para una rotacion conjunta. El collar 200 de accionamiento puede incluir un par de brazos diametralmente opuestos 202 que se extienden de forma axial, teniendo cada uno una orejeta 204 de accionamiento, estando empujadas las orejetas 204 de accionamiento por medio de los brazos 202 hasta acoplarse con aberturas adecuadas 206 definidas por la porcion proximal del miembro tubular 170 de accionamiento. La rotacion del collar 200 de accionamiento junto con el miembro 170 de accionamiento es efectuada ademas por la provision de un par de chavetas 208 diametralmente acoplables con aberturas adecuadas 210 definidas por el extremo proximal del miembro 170 de accionamiento. Una muesca circunferencial 211 en el miembro 170 de accionamiento recibe una junta torica 211' (FIG. 3) para un acoplamiento con la superficie interna de la vaina externa 160.
La rotacion del miembro 170 de accionamiento junto con la vaina externa tubular 160 y el efector terminal interno 180 esta proporcionada por medio de un pasador 212 de conexion que se extiende a traves de estos componentes del instrumento 120. El miembro tubular 170 de accionamiento define una ranura alargada 214 a traves de la cual se extiende el pasador 212 de conexion para acomodar un movimiento de vaiven del miembro de accionamiento con respecto a la vaina tubular externa y al guiaondas interno.
Un mando 216 de rotacion montado en la vaina tubular externa facilita la colocacion rotativa de la porcion alargada 150 con respecto al alojamiento 130 del instrumento coagulador 120 de apriete. Preferentemente, el pasador 212 de conexion une al mando 216 junto con la vaina 160, el miembro 170, y el efector terminal 180 para que giren como una unidad con respecto al alojamiento 130. En la realizacion, la porcion 216' de cubo del mando 216 de rotacion actua para montar de forma giratoria la vaina externa 160, el miembro 170 de accionamiento, y el efector terminal 180 (como una unidad con el mando 216), en el alojamiento 130.
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El collar 200 de accionamiento proporciona una porcion del mecanismo de accionamiento de apriete del instrumento 120, que efectua un movimiento pivotante del brazo 190 de apriete mediante el vaiven del miembro 170 de accionamiento. El mecanismo de accionamiento de apriete incluye, ademas, un yugo 220 de accionamiento que esta conectado de forma operativa con un palanca 222 de operacion, interconectada asf la palanca de operacion, por lo tanto, con el miembro 170 de accionamiento de vaiven por medio del yugo 220 de accionamiento y del collar 200 de accionamiento. La palanca 222 de operacion esta conectada de forma pivotante al alojamiento 130 del aparato (por medio de una montura 223 de pivote) para cooperar de forma similar a unas tijeras con una porcion 224 de empunadura del alojamiento. El movimiento de la palanca 222 hacia la porcion 224 de empunadura traslada el miembro 170 de accionamiento de forma proximal, pivotando de ese modo el brazo 190 de apriete hacia la hoja 180'.
La conexion operativa del yugo 220 de accionamiento con la palanca 222 de operacion esta proporcionada por un resorte 226, que preferentemente comprende un resorte helicoidal 226 de compresion. El resorte 226 encaja dentro de la ranura 228 de resorte definido por el yugo 220 de accionamiento, que a su vez esta colocado entre un par de rebordes 230 de retencion del resorte de la palanca 222 de operacion. El yugo 220 de accionamiento es amovible de forma pivotante con respecto a los rebordes 230 del resorte (en torno a la montura 223 de pivote del alojamiento 130) en oposicion al resorte helicoidal de compresion, que se apoya contra las superficies de las ranuras de resorte definidas por cada uno de los rebordes 230 del resorte. De esta forma, la fuerza que puede ser aplicada sobre el miembro 170 de accionamiento, por medio del movimiento pivotante de la palanca 222 de operacion que actua a traves del yugo 220 de accionamiento y del collar 200 de accionamiento, esta limitada por la fuerza con la que el resorte 226 se apoya en los rebordes 230 del resorte de la palanca 222 de operacion en oposicion al resorte 226. Las porciones de tope del alojamiento 130 limitan el recorrido de la palanca 222 de operacion para evitar una compresion excesiva del resorte 226. En diversas realizaciones, se puede limitar la fuerza aplicada sobre el miembro 170 de accionamiento por medio de uno o mas resortes (no mostrados) colocados de forma operativa entre el collar 200 de accionamiento y el miembro 170. Por ejemplo, se pueden utilizar uno o mas resortes cilfndricos, tales como resortes ondulados. En la patente U.S. n° 6.458.142, que esta incorporada en el presente documento por referencia, se describe una realizacion ejemplar que utiliza un resorte ondulado de esta forma.
Se puede proporcionar una colocacion rotativa indexada de la porcion alargada 150 del presente instrumento coagulador 120 de apriete por medio de la provision de un mecanismo de reten incorporado en el mecanismo de accionamiento de apriete del instrumento 120. Especfficamente, el collar 200 de accionamiento puede incluir un par de rebordes 232 de accionamiento separados de forma axial. Se puede proporcionar una superficie de recepcion del reten entre los rebordes 232 de accionamiento, y puede definir una pluralidad de dientes 234 separados de forma circunferencial. Los dientes 234 pueden definir depresiones de recepcion de retenes generalmente en torno a la periferia del collar 200 de accionamiento. En la realizacion ilustrada en la FIG. 7, se proporcionan doce (12) de los dientes 234, proporcionando de ese modo una colocacion indexada de la porcion alargada 150 del aparato con intervalos de 30° con respecto al alojamiento 130 del aparato.
Se puede conseguir, ademas, un movimiento rotativo indexado mediante la provision de al menos uno, y preferentemente un par, de retenes 236 diametralmente opuestos proporcionados respectivamente en los brazos 238 del yugo en voladizo del yugo 220 de accionamiento. Por medio de esta disposicion, los brazos 238 del yugo estan colocados entre los rebordes 232 de accionamiento para acoplarse con las superficies opuestas de los mismos, y empujan a los retenes 236 hasta acoplarse con el collar 200 de accionamiento. De esta manera, se consigue una rotacion relativa indexada, cooperando los retenes 236 de los brazos 238 del yugo con los rebordes 238 de accionamiento para efectuar un vaiven del miembro 170 de accionamiento. Segun diversas realizaciones, el yugo 220 de accionamiento puede estar formado de un material polimerico adecuado, actuando la fuerza de empuje creada por los brazos 238 del yugo sobre los retenes 236 del mismo cooperando con las depresiones radiales definidas por el collar de accionamiento para resistir un par giratorio relativo inferior a aproximadamente desde 5 a 20 pulgadas-onzas. En consecuencia, se mantiene la porcion alargada 150 del instrumento coagulador 120 de apriete en cualquiera de sus posiciones indexadas de rotacion seleccionadas, con respecto al alojamiento 130, a no ser que se aplique un par (tal como por medio del mando 216 de rotacion) que supere este nivel predeterminado de par. De esta manera, se proporciona una accion de indexado de tipo rapido.
La rotacion de la porcion alargada 150 del presente instrumento coagulador 120 de apriete puede ser efectuada junto con el movimiento rotativo relativo de la unidad 50 de accionamiento ultrasonico con respecto al alojamiento 130. Para unir la porcion alargada 150 con la unidad 50 de accionamiento ultrasonico en una relacion de transmision ultrasonica, la porcion proximal de la vaina tubular externa 160 puede estar dotada de partes planas 240 para una llave (FIG. 3). Las partes planas para una llave permiten que se aplique un par por medio de una llave dinamometrica adecuada o similar para permitir, de ese modo, que el efector terminal 180 sea unido a la unidad 50 de accionamiento ultrasonico. Por lo tanto, la unidad 50 de accionamiento ultrasonico, al igual que la porcion alargada 150, es girable, como una unidad, mediante una manipulacion adecuada del mando 216 de rotacion, con respecto al alojamiento 130 del aparato. El interior del alojamiento 130 esta dimensionado para acomodar tal rotacion relativa de la unidad 50 de accionamiento.
La FIG. 9 ilustra una realizacion de un sistema quirurgico 250 que incluye un instrumento quirurgico 251
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que tiene un efector terminal 256 de un unico elemento. El sistema 250 puede incluir un conjunto 252 de transductores acoplado al efector terminal 256 y una vaina 254 colocada en torno a las porciones proximales del efector terminal 256, como se muestra. El conjunto 252 de transductores y el efector terminal 256 pueden operar de forma similar a la del conjunto 50 de transductores y del efector terminal 180 descrita anteriormente para producir energfa ultrasonica que puede ser transmitida al tejido por medio de una hoja 256'.
La FIG. 10 ilustra un diagrama de bloques de una realizacion de un dispositivo quirurgico 1000, que puede estar configurado con una funcionalidad de realimentacion de la temperatura. Por ejemplo, el circuito 1002 de control puede ajustar una amplitud de la corriente de una senal electrica proporcionada por el generador 1004 al transductor 1006 en respuesta a cambios en una frecuencia de vibracion del efector terminal 1008. Segun diversas realizaciones, cuando se reduce la frecuencia de vibracion del efector terminal 1008, se puede reducir la amplitud de la senal electrica. Esto puede permitir al dispositivo quirurgico 1000 mantener el efector terminal 1008 a una temperatura relativamente constante y, de esta manera proporcionar al dispositivo 1000 un rendimiento mas uniforme.
Durante los procedimientos quirurgicos, el efector terminal 1008 puede ser puesto en contacto con el tejido y puede hacerse que vibre para cortar y/o coagular el tejido, como se ha descrito anteriormente. Cuando esto ocurre, el rozamiento entre el efector terminal 1008 y el tejido puede provocar que aumente la temperatura del efector terminal 1008. Segun aumenta la temperatura del efector terminal 1008, sus propiedades materiales pueden cambiar, provocando cambios en el dispositivo 1000 en su conjunto. Por ejemplo, segun aumenta la temperatura del efector terminal 1008, la relacion entre el desplazamiento del efector terminal 1008 y la amplitud de la corriente de la senal electrica puede cambiar, de forma que el desplazamiento del efector terminal 1008 aumenta sin un aumento correspondiente en la amplitud de la corriente. Ademas, segun aumenta la temperatura del efector terminal 1008, se puede reducir la frecuencia resonante de vibracion del efector terminal 1008. Por ejemplo, las propiedades materiales cambiadas del efector terminal 1008 pueden reducir la frecuencia de resonancia del dispositivo 1000. Como resultado, el generador 1004 puede reducir la frecuencia de la senal electrica de excitacion provoca una reduccion paralela en la frecuencia de vibracion de accionamiento del efector terminal 1008.
El circuito 1002 de control puede monitorizar la senal electrica proporcionada por el generador 1004. Como se describe, una disminucion en la frecuencia de la senal electrica puede indicar un aumento en la temperatura del efector terminal 1008, al igual que un aumento en su desplazamiento. Cuando el circuito 1002 de control detecta una disminucion en la frecuencia de la senal electrica puede ordenar que el generador 1004 reduzca la amplitud de la corriente de la senal electrica. Se puede reducir la amplitud de la corriente de la senal electrica en una cantidad adecuada para mantener la frecuencia del efector terminal 1008 sustancialmente constante, lo que tiene como resultado una temperatura sustancialmente constante del efector terminal 1008. Se puede determinar la cantidad de cambio de amplitud de la corriente necesaria para compensar un cambio dado de frecuencia por medio de un procedimiento experimental o teorico adecuado.
Se apreciara que el dispositivo 1000 puede estar implementado ffsicamente como cualquier dispositivo o sistema ultrasonico adecuado incluyendo, por ejemplo, los sistemas 10 y 250 descritos anteriormente. El circuito 1002 de control puede estar implementado como cualquier circuito analogico o digital adecuado. Por ejemplo, el circuito 1002 de control puede comprender un procesador, por ejemplo, un procesador de senales digitales (DSP).
Ademas de la funcionalidad de realimentacion de la temperatura, o en vez de la misma, descrita anteriormente, una realizacion del dispositivo 1000 mostrado en la FIG. 10 puede estar configurada para detectar una cavitacion, transfiriendose la senal acustica de cavitacion desde el tejido hasta el efector terminal 1008. Esto puede proporcionar al clfnico informacion acerca del estado del tejido. Por ejemplo, antes de que se deseque el tejido, se puede eliminar sustancialmente toda el agua presente en el tejido, bien mediante evaporacion o bien mediante ebullicion. Segun se evapora o hierve el agua, puede generar cavitaciones en el tejido. La deteccion de la presente de estas cavitaciones puede permitir al dispositivo 1000 proporcionar al clfnico una indicacion de que el tejido esta desecado, o esta a punto de estarlo. Se pueden indicar otras transiciones de tejido que se producen durante un corte y/o una coagulacion por medio de otras diversas cavitaciones.
Las cavitaciones del tejido que se originan a partir del tejido en contacto con el efector terminal 1008 (y/o a partir de fluido incluido en el tejido) pueden afectar a la vibracion del efector terminal 1008 y, en consecuencia, la senal electrica entre el generador 1004 y el transductor 1006. Como se ha descrito anteriormente, los elementos piezoelectricos (no mostrados) pueden generar un movimiento en respuesta a una carga electrica. Ademas, los elementos piezoelectricos pueden funcionar inversamente y generar y/o modificar una carga electrica en respuesta a un movimiento. En consecuencia, las cavitaciones del tejido transferidas al efector terminal 1008 pueden ser, a su vez, transferidas a los elementos piezoelectricos del transductor 1006. Esto puede provocar que los elementos piezoelectricos generen cargas que modifiquen la senal electrica entre el generador 1004 y el transductor 1006 de forma proporcional a las cavitaciones del tejido. El aislamiento de la porcion de la senal electrica debido a las cavitaciones de tejido puede indicar la presencia de cavitaciones del tejido, al igual que su frecuencia o sus frecuencias dominantes, y otra informacion.
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La porcion de la senal electrica debido a la cavitacion del tejido puede ser aislada de cualquier forma adecuada. Por ejemplo, el circuito 1002 de control puede incluir un circuito (no mostrado) de filtro para filtrar la frecuencia de accionamiento y cualquier armonico de la misma de la senal electrica. Los componentes restantes de la senal electrica pueden ser debidos a la cavitacion del tejido. El circuito de filtro puede comprender cualquier filtro analogico o digital adecuado.
Muchas cavitaciones del tejido tienen una duracion relativamente breve y, por lo tanto, un contenido relativamente amplio de frecuencia. En consecuencia, las cavitaciones del tejido pueden no ser evidentes a ninguna frecuencia diferenciada y pueden servir, en cambio, para excitar el efector terminal 1008 en su frecuencia de resonancia (por ejemplo, la frecuencia de vibracion) y los armonicos de la misma. Para gestionar este escenario, el circuito 1002 de control puede incluir un procesador u otra funcionalidad para comparar la senal electrica con una senal electrica de comparacion medida cuando el efector terminal 1008 esta sin carga, o no hace contacto con el tejido. La diferencia entre la senal electrica medida y la senal electrica de comparacion puede indicar la presencia de cavitaciones del tejido. Cuando el circuito 1002 de control detecta la presencia de cavitaciones del tejido, puede comunicarlo al clfnico mediante cualquier procedimiento adecuado incluyendo, por ejemplo, utilizando una luz, un medio de visualizacion y/o una senal audible.
La FIG. 11 muestra un grafico 1100 que ilustra los resultados de una prueba ejemplar de una realizacion de un dispositivo quirurgico. En la prueba ejemplar, las cavitaciones externas son identificadas al analizar el contenido de frecuencia de una senal electrica entre un transductor y un efector terminal. En la prueba, se utilizo un efector terminal LCS 14C junto con un transductor HP054 y un generador GEN 300 operado con una frecuencia nominal de accionamiento de 55,5 kHz. Todos estos componentes estan disponibles en Ethicon Endo Surgery, Inc. Se llevo a cabo un ensayo de control al energizar el efector terminal en el aire con una configuracion de potencia de nivel 5 durante un periodo de 100 milisegundos. Durante este tiempo, la senal electrica entre el transductor y el generador fue monitorizada con un osciloscopio AGILENT modelo 5483d. Para cada ensayo experimental, se coloco el efector terminal en un vaso de precipitacion de plastico lleno con 400 cm3 de agua dulce de grifo. Entonces, se energizo el efector terminal con un nivel dado de potencia durante un periodo de 100 milisegundos mientras que se monitorizo la senal electrica entre el transductor y el generador con el osciloscopio. Se realizan tres ensayos experimentales con configuraciones del generador 1, 3 y 5, respectivamente.
El grafico 1100 ilustra las amplitudes de picos de bajo Q en la senal electrica observadas durante los ensayos de control y experimentales a la frecuencia de accionamiento y en los armonicos de la frecuencia de accionamiento. La lfnea 1102 ilustra la frecuencia de accionamiento de 55,5 kHz, la lfnea 1104 ilustra un primer armonico a 45 kHz, y la lfnea 1106 ilustra un segundo armonico a 63 kHz. Puede verse que la amplitud del pico de bajo Q a la frecuencia de accionamiento fue considerablemente mayor durante los ensayos experimentales que durante el ensayo de control. Asimismo, la amplitud de los picos de bajo Q en los armonicos fue mayor durante los ensayos experimentales. Se cree que estas mayores amplitudes a la frecuencia 1102 de accionamiento y los armonicos 1104, 1106 fueron debidas a cavitaciones provocadas cuando se libero el gas disuelto en el agua de grifo por medio de la vibracion del efector terminal. Para apoyar esta conclusion, se debe hacer notar que cuando no se cambio el agua de grifo entre ensayos, los picos de bajo Q fueron significativamente menores, lo que sugiere que todo el gas disuelto habfa sido liberado. Cuando el efector terminal encuentra cavitaciones de tejido, serfan evidentes efectos similares en los picos de bajo Q en las frecuencias de accionamiento y los armonicos del dispositivo.
Ademas de la funcionalidad descrita anteriormente, o en vez de ella, el dispositivo 1000 mostrado en la FIG. 10 puede tener una funcionalidad para monitorizar cambios en la frecuencia del efector terminal 1008. Por ejemplo, el circuito 1002 de control puede monitorizar la frecuencia de vibracion del efector terminal para detectar cambios. Los cambios en la frecuencia del efector terminal pueden indicar cambios en el tejido que hace contacto con el efector terminal. La FIG. 12 muestra un grafico 1200 que ilustra una relacion entre la frecuencia 1202 del efector terminal y la temperatura 1204 del efector terminal durante el procedimiento de coagulacion y de corte. El eje horizontal 1201 representa el tiempo mientras que el eje vertical 1203 representa la temperatura con respecto a la curva 1204 y la frecuencia de vibracion del efector terminal con respecto a la curva 1202. La lfnea vertical 1206 representa el comienzo aproximado de la coagulacion del tejido (por ejemplo, la desnaturalizacion del colageno descrita anteriormente). La lfnea vertical 1208 representa el comienzo aproximado de la desecacion y la transeccion incipiente.
Durante el curso del procedimiento de corte/coagulacion mostrado en el grafico 1200, la curva 1204 de la temperatura aumenta. Antes del comienzo de la coagulacion 1206, la curva 1204 de la temperatura aumenta bruscamente. Entre la coagulacion 1206 y la desecacion 1208, se reduce el aumento en la pendiente de la curva 1204 de la temperatura en funcion del tiempo. Despues de la desecacion 1208, la curva 1204 de la temperatura comienza de nuevo a aumentar mas rapidamente. La curva 1202 de la frecuencia del efector terminal puede ser una imagen especular de la curva 1204 de la temperatura. Por ejemplo, la curva 1202 de la frecuencia puede disminuir rapidamente antes del comienzo de la coagulacion 1206. Al principio de la coagulacion 1206, la curva 1202 de la frecuencia continua disminuyendo, pero lo hace menos rapidamente, demostrando un codo caracterfstico 1210. Aproximadamente en el inicio de la desecacion 1208, la curva 1208 de la frecuencia puede comenzar a disminuir
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mas rapidamente.
Segun diversas realizaciones, el circuito 1002 de control puede estar programado para reconocer los cambios en la tasa de disminucion en la curva 1202 de la frecuencia para derivar una indicacion de cuando ha comenzado a coagularse el tejido, y cuando ha comenzado la desecacion. En una realizacion, el circuito 1002 de control puede monitorizar la frecuencia de vibracion del efector terminal 1008 al monitorizar la frecuencia de la senal electrica entre el generador 1004 y el transductor 1006. Se apreciara que estas dos frecuencias pueden ser la misma. Cuando el circuito 1002 de control detecta que la tasa de disminucion de la frecuencia del efector terminal ha declinado (por ejemplo, la curva 1202 ha alcanzado el codo caracterfstico 1210), el circuito 1002 de control puede generar una indicacion de que la coagulacion ha comenzado. Cuando el circuito 1002 de control detecta que la tasa de disminucion de la frecuencia del efector terminal ha aumentado de nuevo, puede indicar el comienzo de la desecacion. Se pueden comunicar las diversas indicaciones al clfnico por medio del dispositivo 1000 segun cualquier procedimiento adecuado incluyendo, por ejemplo, una luz, un medio de visualizacion y una senal audible. Segun diversas realizaciones, el circuito 1002 de control puede desenergizar el efector terminal 1008, o reducir su amplitud de vibracion, en respuesta a una transicion a la coagulacion o a la desecacion. Esto puede permitir que el clfnico inspeccione el tejido antes de la coagulacion y/o de la desecacion para garantizar que el procedimiento prosigue de forma satisfactoria.
Segun diversas realizaciones, el dispositivo 1000 de la FIG. 10 puede combinar una funcionalidad de cambio de frecuencia con una funcionalidad de deteccion de cavitacion de tejido para indicar el estado del tejido en contacto con el efector terminal 1008. Por ejemplo, aunque la curva 1202 de frecuencia mostrada en la FIG. 12 ilustra un codo caracterfstico 1210 en el inicio de la coagulacion 1206, su tasa de cambio de frecuencia puede cambiar mas progresivamente en el inicio de la desecacion 1208. En consecuencia, puede ser diffcil identificar con precision el inicio de la desecacion 1208 al monitorizar unicamente la frecuencia del efector terminal. Por otra parte, las cavitaciones de tejido son mas habituales aproximadamente en el inicio de la desecacion 1208. Por ejemplo, segun se evacua agua del tejido, puede hervir intensamente, provocando cavitaciones. En consecuencia, el circuito 1002 de control puede estar configurado para identificar el inicio de la coagulacion 1206 al identificar el codo 1210 en la curva 1202 de frecuencia del efector terminal, como se ha descrito anteriormente. Ademas, el circuito 1002 de control puede estar configurado para identificar el inicio de la desecacion 1208 al identificar cavitaciones de tejido, por ejemplo, junto con un aumento en la tasa de reduccion de la curva 1202 de frecuencia del efector terminal. De nuevo, se pueden comunicar diversas indicaciones al clfnico por medio del dispositivo 1000 segun cualquier procedimiento adecuado incluyendo, por ejemplo, una luz, un medio de visualizacion y una senal audible. Ademas, el dispositivo 1000 puede ser desenergizado, o se puede reducir la frecuencia de vibracion del efector terminal 1008, tras una transicion a la coagulacion o a la desecacion, como se ha descrito anteriormente.
La FIG. 13 ilustra un diagrama de bloques de una realizacion de un dispositivo quirurgico 1300 configurado para derivar una realimentacion del efector terminal teniendo en cuenta un coeficiente de desnaturalizacion del colageno (CCD). El CCD puede representar una cantidad de rozamiento entre el efector terminal 1308 y una porcion de tejido (no mostrada). El analisis de una curva de CCD tomada durante el curso de un procedimiento de corte y/o de coagulacion puede proporcionar informacion acerca del progreso del corte y de la coagulacion, al igual que informacion acerca de la porcion de tejido incluyendo, por ejemplo, su grosor y diametro exterior.
Segun diversas realizaciones, se puede calcular el CCD como una funcion de variables, por ejemplo, incluyendo: (i) potencia proporcionada al efector terminal 1308; (ii) la frecuencia de vibracion del efector terminal 1308; (iii) el desplazamiento del efector terminal 1308 durante un ciclo; y (iv) una fuerza de apriete aplicada a la region de tejido entre el mecanismo 1310 de apriete y el efector terminal. El propio mecanismo 1310 de apriete puede ser cualquier mecanismo adecuado para apretar o ejercer de otra manera una fuerza sobre la region de tejido contra el efector terminal. Segun diversas realizaciones, el mecanismo 1310 de apriete puede ser similar al mecanismo 190 de apriete descrito anteriormente. El circuito 1302 de control del dispositivo 1300 puede hallar los valores de las anteriores variables en el tiempo. Por ejemplo, se puede hallar la potencia proporcionada al efector terminal 1308 al considerar la senal electrica entre el generador 1304 y el transductor 1306 mientras que el efector terminal 1308 esta bajo carga (por ejemplo, en contacto con la region de tejido). El desplazamiento por ciclo del efector terminal 1308 puede ser una funcion de la amplitud de la corriente de la senal electrica. Ademas, como se ha descrito anteriormente, la frecuencia de vibracion del efector terminal 1308 puede ser sustancialmente similar a la de la senal electrica.
Se puede hallar la fuerza de apriete del efector terminal 1308 y del mecanismo 1310 de apriete segun cualquier procedimiento adecuado. Por ejemplo, segun diversas realizaciones, el mecanismo 1310 de apriete puede ser accionado por medio de un motor electrico. Por ejemplo, con referencia a la realizacion mostrada en la FlG. 2, el miembro 170 de accionamiento de vaiven puede ser trasladado de forma distal y proximal por medio del motor 1312. En esta realizacion, se puede derivar la fuerza de apriete entre el mecanismo 1310 de apriete y el efector terminal 1308 de un sensor 1314 en comunicacion con el circuito 1302 de control. El sensor puede estar colocado en cualquier ubicacion adecuada en comunicacion con el efector terminal 1308, el mecanismo 1310 de apriete y/o una porcion de la empunadura (no mostrada en la FIG. 13) del dispositivo. La realizacion mostrada en la FIG. 4 ilustra un ejemplo de un sensor 1316 colocado entre la almohadilla 192 del tejido del brazo de apriete y el brazo 190 de
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apriete. Ademas, la realizacion mostrada en la FIG. 2 ilustra un sensor 1318 colocado entre una porcion de la palanca 222 de operacion y el collar 200 de accionamiento. En una realizacion, se puede considerar a la fuerza de apriete como una constante y puede ser tenida en cuenta en los calculos de CCD como tal.
El dispositivo 1300 puede utilizar la curva de CCD para detectar cuando la porcion de tejido entra en las etapas de coagulacion y de desecacion. La FIG. 14 muestra un grafico que ilustra una curva 1402 de CCD durante una transeccion completa de coagulacion y de corte. La curva 1402 de CCD fue derivada con un instrumento ultrasonico que tenia un efector terminal de nucleo macizo alimentado por un dispositivo generador GEN03 disponible en Ethicon Endo Surgery, Inc. La potencia del generador estaba fijada en el nivel tres (3); el desplazamiento del efector terminal 1408 estaba fijado en 55 micrometros; la frecuencia de vibracion del efector terminal estaba configurada a 55,5 kHz; y se utilizo una fuerza de apriete de 2 libras. Se puede dividir la curva 1402 en tres regiones. Una primera region 1408 puede corresponderse a momentos anteriores al inicio de la coagulacion 1404 y puede tener una pendiente sustancialmente negativa. Una segunda region 1410 puede corresponderse a momentos entre el inicio de la coagulacion 1404 y el inicio de la desecacion 1406 y puede tener una pendiente sustancialmente neutra. Una tercera region 1412 puede corresponderse a momentos posteriores al inicio de la desecacion 1406 y puede tener una pendiente sustancialmente positiva. Segun diversas realizaciones, el circuito de control puede monitorizar la pendiente de la curva 1402 de CCD para determinar el estado de la porcion de tejido. Las transiciones a la coagulacion o a la desecacion pueden ser indicadas al clinico segun cualquier procedimiento adecuado incluyendo, por ejemplo, una luz, un medio de visualizacion y/o una senal audible. Ademas, segun se describe, el circuito 1302 de control puede desenergizar el efector terminal 1308 en respuesta a una transicion a la coagulacion o a la desecacion.
El circuito 1302 de control tambien puede utilizar la curva 1402 de CCD para determinar otras caracteristicas de la porcion de tejido incluyendo, por ejemplo, su grosor y diametro exterior. Se apreciara que la porcion de tejido puede ser una porcion maciza de tejido, o puede definir una luz (por ejemplo, una arteria, una vena u otro tejido tubular). La FIG. 15 muestra un grafico que ilustra un coeficiente de curva 1502 de desnaturalizacion del colageno. La curva 1502 fue derivada durante la coagulacion y la desecacion de una arteria carotida utilizando un instrumento ultrasonico que tenia un efector terminal de nucleo macizo alimentado por un dispositivo generador GEN03. La potencia del generador estaba fijada en el nivel cinco (5). El desplazamiento del efector terminal 1408 estaba fijada en 55 micrometres; la frecuencia de vibracion del efector terminal estaba configurada a 55,5 kHz; y se utilizo una fuerza de apriete de 2 libras. La curva 1502 de CCD ha sido dividida en nueve regiones 1504, 1506, 1508, 1510, 1512, 1514, 1516, 1518 y 1520 que tienen una pendiente sustancialmente constante.
Diversas propiedades de cada una de las nueve regiones de la curva 1402 de CCD pueden correlacionarse con propiedades de la porcion de tejido, tal como el grosor y el diametro externo. En un experimento ejemplar, se coagularon y cortaron catorce arterias carotidas de diversos diametros con un instrumento ultrasonico que tenia un efector terminal de nucleo macizo alimentado por un dispositivo generador GEN03. La siguiente Tabla 1 muestra el diametro externo y el grosor de la pared de las arterias carotidas, al igual que la fuerza de apriete y el nivel de potencia utilizados. La columna de ajuste polinomico enumera el exponente del ajuste polinomico de la primera region 1504 de la curva de CCD para cada ensayo. El valor normalizado de CCD muestra el valor de CCD para cada ensayo normalizado al dividir cada valor individual de CCD por el valor de CCD al final de la primera region 1504.
Tabl a 1:
Ensayo
Fuerza de apriete Nivel de potencia Diametro externo (pulgadas) Grosor de la pared (cm) Ajuste polinomico Valor normalizado de CCD
1
0,4 3 0,169 0,107 0,0181 1,2826
2
1 3 0,169 0,107 0,254 *
3
0,4 5 0,117 0,10 0,227 *
4
1 5 0,117 0,10 0,251 *
5
0,4 4 0,146 0,107 0,251 1,16738
6
1 4 0,146 0,107 0,361 1,47
7
0,4 4 0,136 0,13 0,266 1,14
8
1 4 0,136 0,13 1,231 1,23
9
0,7 3 0,094 0,114 1,765 1,05
10
0,7 5 0,094 0,114 0,744 1,35
11
0,7 3 0,156 0,114 0,15 1,1
12
0,7 5 0,156 0,114 0,214 1,49
13
0,7 4 0,119 0,089 0,791 1,27
14
0,7 4 0,119 0,089 0,295 1,23
La FIG. 16 muestra una serie de curvas 1602, 1604, 1606, 1608 que ilustran relaciones entre el valor normalizado del primer punto de la primera region de la fuerza de apriete, del nivel de potencia, del diametro exterior
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y del grosor de pared de la curva de CCD para los ensayos mostrados en la Tabla 1. El grado de la pendiente de las curvas 1602, 1604, 1606, 1608 puede indicar el grado de correlacion entre la variable correspondiente y el valor normalizado del primer punto de la primera region de la curva de CCD. Se puede ver que todas las curvas 1602, 1604, 1606 y 1608 tienen pendientes no nulas y, por lo tanto, se correlacionan todas sus variables correspondientes con la curva de CCD. Se puede ajustar un modelo matematico, tal como un modelo cuadratico, a los resultados de los ensayos, tales como los mostrados en la Tabla 1, para derivar una o mas ecuaciones relacionadas con el valor normalizado del primer punto de la primera region de la curva de CCD, la fuerza de apriete, el nivel de potencia, el diametro exterior y el grosor de la pared.
Con referencia de nuevo a la realizacion mostrada en la FIG. 13, el circuito 1302 de control puede monitorizar una curva de CCD generada segun el dispositivo 1300 coagula y/o corta la porcion de tejido. Tras identificar una region de la curva de CCD que tiene una pendiente sustancialmente similar, el circuito 1302 de control puede derivar una propiedad que describe la region incluyendo, por ejemplo, una pendiente de la region, un valor normalizado de la curva en la region y/o una longitud de la primera region. Entonces, el circuito 1302 de control puede derivar una propiedad de la porcion de tejido que incluye, por ejemplo un diametro exterior de la porcion de tejido o un grosor de la porcion de tejido. Las propiedades del tejido pueden ser derivadas segun cualquier procedimiento adecuado. Por ejemplo, se pueden desarrollar modelos matematicos que relacionan propiedades de la region con propiedades del tejido, por ejemplo, como se ha descrito anteriormente. El circuito 1302 de control puede utilizar un modelo matematico predeterminado para relacionar la propiedad de la region y la propiedad del tejido. Ademas, segun diversas realizaciones, se pueden generar tablas de consulta que relacionan propiedades de la region con propiedades del tejido.
La FIG. 17 ilustra una realizacion de un efector terminal 1700 para un dispositivo quirurgico que incluye transductores 1702, 1704, 1706 de modo radial. Cuando son excitados por una senal electrica (por ejemplo, procedente de un generador), los transductores 1702, 1704, 1706 de modo radial pueden generar vibraciones ultrasonicas perpendiculares a un eje longitudinal 1710. Las vibraciones ultrasonicas pueden tener antinodos en las superficies radiales de los transductores 1702, 1704, 1706. Como resultado, toda la superficie radial del efector terminal 1700 puede estar activa para coagular y cortar el tejido. Un miembro central 1708 puede extenderse a lo largo del eje longitudinal 1710 y puede servir de electrodo para algunos de los transductores 1702, 1704, 1706 de modo radial, o para todos ellos. Ademas, la superficie radial externa de los transductores 1702, 1704, 1706 de modo radial puede estar recubierta con una sustancia electricamente conductora o, de forma alternativa, puede estar encerrada en una vaina tubular metalica, cualquiera de las cuales puede servir de electrodo. Aunque se muestran multiples transductores 1702, 1704, 1706, se apreciara que algunas realizaciones pueden incluir unicamente un transductor de modo radial.
La FIG. 18 ilustra una realizacion del efector terminal 1700 de la FIG. 17 instalado en un instrumento quirurgico 1800 que incluye un brazo 1802 de apriete. Se muestran transductores 1701 y 1703 de modo radial adicionales, aunque se apreciara que se puede utilizar cualquier numero adecuado de transductores. El brazo 1802 de apriete puede ser pivotable hacia el efector terminal 1700 de forma similar a la forma en la que el brazo 190 de apriete es pivotable hacia el efector terminal 180 en la realizacion mostrada en la FIG. 4. Segun diversas realizaciones, el miembro central 1708 del efector terminal 1700 puede ser flexible. Esto puede permitir que los diversos transductores 1702, 1704, 1706 de modo radial se flexionen entre si. La FIG. 19 ilustra una realizacion del efector terminal 1700 de la FIG. 17 en la que el miembro central 1708 es flexible. La flexibilidad del miembro central 1708 puede permitir que los distintos transductores de modo radial, aquf 1706 y 1704, se flexionen entre si, lo que da lugar a un efector terminal flexible y articulatable 1700. La articulacion del efector terminal 1700 puede ser proporcionada de cualquier forma adecuada. Por ejemplo, el miembro central flexible 1708 puede definir una luz central (no mostrada). Los hilos metalicos (no mostrados) pueden discurrir en el interior del miembro central 1708 en lados opuestos de la luz central. Se puede utilizar un mando de articulacion u otro implemento articulado cerca de una porcion de mango del instrumento para retraer uno de los hilos metalicos. Cuando se retrae un hilo metalico, puede provocar que el miembro central flexible 1708 y, por lo tanto, el efector terminal 1700 se articulen en la direccion del hilo retrafdo. Por ejemplo, si se retrae un hilo en el lado derecho del miembro central 1708, entonces el efector terminal 1700 puede articularse hacia la derecha. Se apreciara que esto es unicamente un ejemplo de un mecanismo de articulacion y que se puede utilizar cualquier procedimiento adecuado de articulacion.
Las FIGURAS 20-21 ilustran una realizacion del efector terminal 1700 de la FIG. 17 que incluye un transductor 2002 que define una concavidad 2004. El transductor 2002 puede utilizar la concavidad 2004 para dirigir la energfa ultrasonica al tejido que no hace contacto ffsico directo con el transductor 2002 ni con el efector terminal 1700. Por ejemplo, la concavidad del transductor 2002 puede servir para concentrar energfa ultrasonica en los puntos 2006. Segun diversas realizaciones, la concavidad 2004 puede extenderse de forma radial en torno al transductor 2002, como se muestra en la realizacion de la FIG. 21. En consecuencia, el punto focal 2006 se extiende de forma radial en torno al transductor 2002 formando un toroide.
Los dispositivos dados a conocer en el presente documento pueden estar disenados para ser desechados despues de un unico uso, o pueden estar disenados para ser utilizados multiples veces. En cualquier caso, sin embargo, el dispositivo puede ser reacondicionado para ser reutilizado despues de al menos un uso. El
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reacondicionamiento puede incluir cualquier combinacion de las etapas de desmontaje del dispositivo, seguido de una limpieza o sustitucion de elementos particulares, y un nuevo montaje subsiguiente. En particular, el dispositivo puede ser desmontado, y se puede sustituir o retirar cualquier numero de elementos o componentes particulares del dispositivo en cualquier combinacion. Tras la limpieza y/o sustitucion de componentes particulares, se puede volver a montar el dispositivo para un uso subsiguiente bien en una instalacion de reacondicionamiento, o bien por un equipo quirurgico inmediatamente antes de un procedimiento quirurgico. Los expertos en la tecnica apreciaran que el reacondicionamiento de un dispositivo puede utilizar una variedad de tecnicas para el desmontaje, la limpieza/sustitucion, y el nuevo montaje. Tanto el uso de tales tecnicas y el dispositivo reacondicionado resultante se encuentran dentro del alcance de la presente solicitud.
Preferentemente, las diversas realizaciones descritas en el presente documento seran procesadas antes de una cirugfa. En primer lugar, se obtiene un instrumento nuevo o usado y si es necesario es limpiado. Entonces, se puede esterilizar el instrumento. En una tecnica de esterilizacion, se coloca el instrumento en un recipiente cerrado y sellado, tal como una bolsa de plastico o una bolsa TYVEK®. Entonces, se colocan el recipiente y el instrumento en un campo de radiacion que puede penetrar el recipiente, tal como radiacion gamma, rayos X o electrones de alta energfa. La radiacion mata las bacterias en el instrumento y en el recipiente. Entonces, se puede almacenar el instrumento esterilizado en el recipiente esteril. El recipiente sellado mantiene al instrumento esteril hasta que es abierto en la instalacion medica.
Es preferente que el dispositivo sea esterilizado antes de la cirugfa. Esto puede llevarse a cabo de cualquier numero de formas conocidas por los expertos en la tecnica, incluyendo radiacion beta o gamma, oxido de etileno, vapor.
Aunque se han descrito diversas realizaciones en el presente documento, se pueden implementar muchas modificaciones y variaciones a esas realizaciones. Por ejemplo, se pueden emplear distintos tipos de efectores terminales. Ademas, cuando se dan a conocer materiales para ciertos componentes, se pueden utilizar otros materiales. Se pretende que la anterior descripcion abarquen todas las modificaciones y las variaciones de ese tipo.

Claims (9)

  1. 5
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    Reivindicaciones
    1. Un dispositivo quirurgico que comprende:
    un transductor (40, 1006, 1306) para recibir una senal electrica de un generador (30, 1004, 1304) a una frecuencia de activacion, el transductor (40, 1006, 1306) para proporcionar vibraciones a la frecuencia de activacion;
    y un efector terminal (180, 1008, 1308) acoplado con el transductor (40, 1006, 1306) y que se extiende desde el transductor (40, 1006, 1306) a lo largo de un eje longitudinal; y caracterizado por un circuito de control (1002, 1302) configurado para:
    detectar un cambio en una frecuencia de vibracion del efector terminal (180, 1008, 1308) y para identificar como un resultado una condicion de tejido en contacto con el efector terminal (180, 1008, 1308); y
    para generar una senal que indica la existencia de esa condicion; y medios sensibles a la senal para indicar la condicion a un practicante clfnico.
  2. 2. El dispositivo quirurgico de la reivindicacion 1, en el que el circuito de control (1002) esta configurado para implementar un filtro para filtrar la frecuencia de activacion de las frecuencias de vibracion.
  3. 3. El dispositivo quirurgico de la reivindicacion 1, en el que el circuito de control (1002) esta configurado para implementar un filtro para filtrar al menos un harmonico de la frecuencia de activacion de las frecuencias de vibracion.
  4. 4. El dispositivo quirurgico de la reivindicacion 1, en el que el circuito (1002) esta configurado tambien para comparar una frecuencia de vibracion del efector terminal con una frecuencia de vibracion sin cargar del efector terminal cuando el efector terminal no esta en contacto con el tejido.
  5. 5. El dispositivo quirurgico de la reivindicacion 1, en el que el circuito de control (1002) esta configurado ademas para detectar una reduccion en una tasa de reduccion de la frecuencia de vibracion y para identificar como un resultado el inicio de la coagulacion del tejido.
  6. 6. El dispositivo quirurgico de la reivindicacion 1, en el que el circuito de control (1002) esta configurado ademas para detectar un aumento en una tasa de reduccion de la frecuencia de vibracion y para identificar como un resultado el inicio de la desecacion del tejido.
  7. 7. El dispositivo quirurgico de la reivindicacion 1, en el que el circuito de control (100) esta ademas configurado para:
    detectar un aumento en una tasa de reduccion de una frecuencia de vibracion;
    detectar la presencia de una frecuencia de vibracion que no sea la frecuencia de activacion, originandose del tejido en contacto con el efector terminal; y
    tras detectar el aumento en la tasa de reduccion de la frecuencia de vibracion y detectar la presencia de dicha otra frecuencia de vibracion, identificar el comienzo de la desecacion del tejido.
  8. 8. El dispositivo quirurgico de la reivindicacion 5, en el que el circuito de control (1002) esta tambien configurado para:
    detectar una frecuencia de vibracion que no sea la frecuencia de activacion, originandose del tejido en contacto con el efector terminal; y
    identificar el inicio de desecacion en respuesta a la deteccion de esa otra frecuencia de vibracion.
  9. 9. El dispositivo quirurgico de la reivindicacion 5, en el que el circuito de control (1002) esta tambien configurado para:
    detectar un aumento en una tasa de reduccion de la frecuencia de vibracion; y identificar un inicio de desecacion en respuesta a ese aumento.
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