ES2731049T3 - Sistema de cirugía por orificio natural - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B17/3439—Cannulas with means for changing the inner diameter of the cannula, e.g. expandable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/42—Gynaecological or obstetrical instruments or methods
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B2017/345—Cannulas for introduction into a natural body opening
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B2017/345—Cannulas for introduction into a natural body opening
- A61B2017/3452—Cannulas for introduction into a natural body opening for the rectum, e.g. for hemorrhoid surgery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
- A61B2017/3466—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals for simultaneous sealing of multiple instruments
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
- A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
- A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
- A61B2017/3486—Balloon
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Abstract
Un sistema (6100) de puerta de acceso quirúrgico para realizar operaciones quirúrgicas en un orificio natural que comprende: un anillo exterior (6120), cuyo anillo exterior está configurado para disponerse cerca del orificio natural del paciente; y un cuerpo tubular (6130) que tiene un eje geométrico longitudinal, un extremo proximal y un extremo distal, en el que el extremo proximal del cuerpo tubular está acoplado al anillo exterior (6120); una serie de brazos (6105) dispuestos a lo largo del eje longitudinal del cuerpo tubular, teniendo cada brazo un extremo proximal unido a un primer anillo (6103) y un extremo distal unido a un segundo anillo, en el que el segundo anillo (6101) está fijo al cuerpo tubular; caracterizado por que comprende, además: un globo mecánico (6114) dispuesto alrededor del cuerpo tubular (6130), comprendiendo el globo mecánico (6114) dicha serie de brazos (6105) dispuestos a lo largo del eje longitudinal del cuerpo tubular (6130); y un tercer anillo dispuesto alrededor del cuerpo tubular proximal al primer anillo, estando el tercer anillo (6102) adaptado para moverse a lo largo del cuerpo tubular (6130) para acoplarse al primer anillo (6103) y empujar el primer anillo (6103) hacia el extremo distal del cuerpo tubular (6130), aplicando así una carga a los brazos (6105) y haciendo que se abran desde el cuerpo tubular (6130).
Description
DESCRIPCIÓN
Sistema de cirugía por orificio natural
ANTECEDENTES
La presente solicitud se refiere, en general, a dispositivos quirúrgicos y, más particularmente, a un dispositivo de acceso adaptado para su uso con una tapa, que es útil en operaciones quirúrgicas de entrada única por orificio natural y que es particularmente útil en operaciones quirúrgicas vaginales.
Los dispositivos de acceso se usan comúnmente en cirugía para facilitar la introducción de diversos instrumentos quirúrgicos en cavidades, orificios, conductos, vasos biológicos naturales y en otras regiones internas del cuerpo. Estos dispositivos de acceso incluyen, por ejemplo, dispositivos que facilitan la introducción de una aguja en un vaso y trocares que facilitan la introducción de instrumentos laparoscópicos en el abdomen del cuerpo.
Algunos de estos dispositivos de acceso se introducen en regiones que incluyen un fluido o gas a presión. En el caso de un dispositivo de acceso con aguja, la presión puede provenir de un líquido, como la sangre. En el caso de un trocar, la presión puede provenir de un gas, como un gas de insuflación. En cualquier caso, es deseable hacer posible la introducción del instrumento quirúrgico en la cavidad sin permitir el escape del gas o fluido presurizado.
En el caso de los trocares, una cánula en el extremo distal del trocar está típicamente conectada a un alojamiento de junta de obturación en el extremo proximal del trocar. Juntos, la cánula y el alojamiento, forman un canal de trabajo a través del cual se pueden insertar varios instrumentos para acceder a la cavidad. Los mecanismos de junta de obturación generalmente están dispuestos en el alojamiento e incluyen una válvula de diafragma que obtura el canal de trabajo cuando un instrumento está colocado en su lugar, y una válvula de cierre cero que obtura el canal de trabajo cuando se retira el instrumento.
Se pueden encontrar ejemplos de puertas o lumbreras de acceso quirúrgico del tipo general anterior en las solicitudes de patente con los números de publicación US 2013/245381 A 1, WO 2009/117435 A2 y US 2011/144443 A1.
Las puertas de acceso quirúrgico convencionales permiten el acceso de un solo instrumento a través de cada puerta, o permiten el acceso de múltiples instrumentos a través de una cánula rígida. Algunos dispositivos, como las unidades de microcirugía endoscópica transanal (MET) requieren que el dispositivo se fije a la mesa de operaciones para soportar el peso del dispositivo, así como para ubicar la posición del dispositivo respecto del paciente. Estos dispositivos no proporcionan flexibilidad al cirujano para seleccionar el tamaño del instrumento y restringen el movimiento del instrumento con sus cánulas rígidas. Además, los cirujanos realizan operaciones quirúrgicas laparoscópicas a través de uno solo o de un número limitado de puertas de acceso. Las operaciones se pueden realizar a través de una única incisión de dos (2) centímetros en el ombligo o, en ciertos casos, por vía transvaginal o transanal. Lo que se necesita es un sistema que satisfaga las necesidades de estos nuevos procedimientos, facilitando el movimiento más flexible de los instrumentos laparoscópicos a través de una sola o de un número limitado de puertas mientras se evita el escape de gases o fluidos presurizados y se permite la extracción de grandes muestras. Lo que se necesita particularmente es un sistema de acceso que se pueda desplegar en una cavidad natural del cuerpo, como la vagina, que proporcione un sistema obturado para la insuflación y una plataforma para la introducción de múltiples instrumentos quirúrgicos de diferentes tamaños, mientras se mantiene la estabilidad suficiente para anclar el sistema dentro de la cavidad sin dañar la pared de la cavidad del cuerpo.
COMPENDIO DE LA INVENCIÓN
La reivindicación 1 define la invención, y las reivindicaciones dependientes describen las realizaciones preferidas. La invención se refiere a un sistema de puerta de acceso quirúrgico adaptado para realizar operaciones quirúrgicas en un orificio natural, que comprende un anillo exterior, en el que el anillo exterior está configurado para estar dispuesto cerca del orificio natural del paciente; un cuerpo tubular que tiene un eje geométrico longitudinal, un extremo proximal y un extremo distal, en donde el extremo proximal del cuerpo tubular está acoplado al anillo exterior; y un globo mecánico dispuesto alrededor del cuerpo tubular, comprendiendo el globo mecánico una serie de brazos dispuestos a lo largo del eje longitudinal del cuerpo tubular, teniendo cada brazo un extremo proximal unido a un primer anillo y un extremo distal unido a un segundo anillo, en donde el segundo anillo está fijado al cuerpo tubular; y un tercer anillo dispuesto alrededor del cuerpo tubular proximal al primer anillo, estando el tercer anillo adaptado para moverse a lo largo del cuerpo tubular para aplicarse al primer anillo y empujar el primer anillo hacia el extremo distal del cuerpo tubular, aplicando así una carga en los brazos y haciendo que se separen del cuerpo tubular. El globo mecánico también se puede usar en combinación con una pestaña de compresión o un cono de refuerzo.
Opcionalmente, los brazos consisten en un material semirrígido. En algunas realizaciones, cada uno de los brazos comprende, además, una unión articulada a lo largo de la longitud del brazo.
La puerta de acceso puede comprender una pluralidad de dientes dispuestos a lo largo de la superficie exterior del cuerpo tubular y una pluralidad de fiadores dispuestos a lo largo de una superficie interior del ánima del tercer anillo, estando los dientes adaptados para aplicarse a los fiadores para facilitar el movimiento unidireccional del cuerpo
tubular a través el ánima del tercer anillo.
BREVE DESCRIPCIÓN DE LOS DIBUJOS
La Figura 1 es una vista lateral de un paciente en cirugía que ilustra una realización de un dispositivo de acceso colocado en el abdomen y en uso.
La Figura 2 es una vista lateral en sección transversal que ilustra una realización de un dispositivo de acceso, con el retractor de herida retrayendo la vagina de una paciente, y una tapa de gel que obstruye la abertura del retractor de herida.
La Figura 3 es una vista frontal que ilustra una realización de un dispositivo de acceso desplegado y en uso en la boca del paciente.
La Figura 4 es una vista superior ilustrada de un paciente en decúbito prono con una realización del dispositivo de acceso desplegado y en uso en el ano del paciente.
La Figura 5A es una imagen de los componentes de un sistema de dispositivo de acceso útil para cirugía por orificio natural; la Figura 5B es una vista en perspectiva del retractor de la Figura 5A.
La Figura 6A es una vista en perspectiva de un ejemplo de un retractor de orificio natural que tiene una pestaña de oclusión.
La Figura 6B es un corte lateral del retractor de orificio natural de la Figura 6A.
La Figura 6C es una vista lateral de un ejemplo de un retractor de orificio natural que tiene una pestaña de compresión.
La Figura 6D es un corte lateral del retractor de orificio natural de la Figura 6C.
La Figura 6E es una vista en perspectiva de un ejemplo de un retractor de orificio natural que tiene un cono de refuerzo.
La Figura 6F es una vista lateral de una realización de un retractor de orificio natural de acuerdo con la presente invención que tiene un globo mecánico, mostrado en un estado sin comprimir, o retraído.
La Figura 6G es una vista lateral del retractor de orificio natural de la Figura 6F, mostrado en un estado comprimido o expandido.
DESCRIPCIÓN DETALLADA DE CIERTAS REALIZACIONES
Las realizaciones de un sistema de dispositivo de acceso de instrumento quirúrgico son útiles, por ejemplo, para operaciones de cirugía laparoscópica de incisión única, puerta única y/o puerta limitada, por ejemplo, para operaciones abdominales (Figura 1), transvaginales (Figura 2), transorales (Figura 3) y transanales (Figura 4). Varios dispositivos de acceso de instrumentos quirúrgicos se describen en la publicación de solicitud de patente estadounidense número 2009/0187079, titulada "SURGICAL INSTRUMENT ACCESS DEVICE", presentada el 22 de enero de 2009, y en la patente estadounidense número 7.727.146, titulada "WOUND RETrAc TOR WITH GEL CAP".
La Figura 5A muestra un ejemplo de un sistema de dispositivo de acceso que comprende un retractor 6100, un introductor 6400 mostrado insertado en el retractor como para colocarlo en un orificio del cuerpo, una tapa 6200, uno o más orificios 6310 y un obturador 6600, que es útil en procedimientos de orificio único y/o limitado. El retractor 6100 se coloca y/o se ubica en, por y/o a través de una incisión quirúrgica y/o un orificio corporal para agrandar, darle otra forma y/o aislar la incisión u orificio corporal. La tapa 6200 proporciona una pared corporal artificial a través de la cual los instrumentos acceden al interior del cuerpo de un paciente, por ejemplo, una cavidad corporal, a través de puertas 6310. El retractor 6100 puede introducirse en un orificio usando el introductor 6400; las puertas 6310 se pueden colocar a través de la tapa de gel usando el obturador 6600. Los componentes del dispositivo de acceso comprenden cualquier material compatible biológicamente adecuado.
Con la tapa de gel 6200 unida al retractor 6100, el sistema de dispositivo de acceso permite al usuario insuflar el orificio, como el canal vaginal. La distensión del canal causada por la insuflación proporciona una mayor visualización de la anatomía (cuando se compara, por ejemplo, con la histerectomía vaginal tradicional) y se elimina la necesidad del uso de retractores mecánicos rígidos que pueden causar daño a los tejidos blandos. La tapa de gel puede ser desprendida en cualquier momento durante el procedimiento quirúrgico para permitir la extracción de muestras.
El retractor 6100 está hecho de un polímero termoestable o elastómero termoplástico semi-maleable. Para su uso en operaciones vaginales, una longitud de aproximadamente 4 cm a 7 cm y un diámetro de aproximadamente 3 cm a 5 cm se adaptarán bien a una amplia gama de anatomías. El retractor retrae y ocluye la vagina. Sujetadores de sutura 6160 en el extremo proximal 6152 y/o una pestaña 6110 a lo largo del cuerpo tubular pueden ayudar a evitar que el retractor se desprenda una vez colocado. La tapa de gel 6200 se puede unir con la ayuda de una palanca 6135 que se bloquea debajo del anillo proximal 6120 del retractor 6100. Esto crea una obturación resistente a la presión y es posible la insuflación a través de puertas de insuflación 6145 en la tapa de gel. La evacuación de humo es posible a través de la puerta que no se use para la insuflación. Las puertas 6310 para instrumentos se pueden colocar en la tapa de gel 6200 para permitir el uso de varios instrumentos laparoscópicos. Luego se puede separar la tapa de gel y las muestras pueden retirarse a través del retractor 6100.
Volviendo a la Figura 5B, el anillo exterior 6120 es proximal a una sección de embudo 6140. El anillo exterior 6120 mostrado tiene una planta sustancialmente circular. El anillo exterior 6120 puede estar dimensionado y configurado
para acoplarse herméticamente a una tapa u otro dispositivo de acceso sobre el mismo. Pueden estar dispuestos uno o más puntos de sutura 6160 en el retractor 6100 adyacente al anillo exterior 6120. Dos puntos de sutura 6160 son, en general, diametralmente opuestos con relación al perfil generalmente circular del anillo exterior 6120. El retractor puede incluir más o menos de dos puntos de sutura dispuestos en varias ubicaciones con respecto al anillo exterior 6120.
Continuando con la referencia a la Figura 5B, el cuerpo tubular 6130 tiene un perfil generalmente circular que define un paso 6150 generalmente cilíndrico. Se desea que el paso generalmente cilíndrico sea lo suficientemente grande como para acomodar más de un instrumento laparoscópico en el mismo, de modo que se pueda usar un dispositivo de acceso único por orificio natural para proporcionar acceso a múltiples instrumentos quirúrgicos en una cavidad corporal. Además, se desea que el paso generalmente cilíndrico sea lo suficientemente grande para que múltiples instrumentos quirúrgicos colocados a través de él se puedan trasladar o puedan pivotar entre sí, para permitir al cirujano manipular los instrumentos como desee durante una operación quirúrgica. El paso generalmente cilíndrico se extiende entre un extremo proximal 6152 del retractor 6100 adyacente al anillo exterior 6120 hasta un extremo distal 6154 del retractor 6100 adyacente a la pestaña 6110. En las Figuras 5A y 5B, el cuerpo tubular 6130 tiene una sección transversal circular, pero el cuerpo tubular 6130 puede tener otra forma, por ejemplo, una sección transversal oval, una sección transversal octagonal, u otras formas que puedan ser apropiadas para el orificio natural de interés. Algunos ejemplos del cuerpo tubular 6130 pueden comprender uno o más recubrimientos que proporcionan funcionalidad adicional, por ejemplo, un recubrimiento antimicrobiano.
En la realización ilustrada, el segmento de embudo 6140 proporciona una reducción diametral entre el diámetro relativamente grande del anillo exterior 6120, que está dimensionado y configurado para ser acoplado de manera separable a un dispositivo de acceso tal como una tapa, y el diámetro relativamente más pequeño del paso 6150, que está dimensionado para ajustar dentro de un orificio natural con una distensión mínima del orificio. El segmento de embudo 6140 tiene una superficie interior que puede proporcionar una superficie de apoyo para un obturador o introductor usado para hacer avanzar el retractor 6100 hacia el interior de una cavidad del cuerpo. El segmento de embudo puede tener un estrechamiento sustancialmente lineal entre el diámetro relativamente grande y el diámetro relativamente más pequeño, de modo que la superficie interior sea un segmento troncocónico. En otros ejemplos, el segmento de embudo 5 puede tener un perfil curvado entre el diámetro relativamente grande y el diámetro relativamente más pequeño. En otros ejemplos, puede no haber ninguna sección de embudo, y que el cuerpo tubular se conecte directamente al anillo exterior.
Puede ser deseable que el anillo exterior 6120 sea relativamente rígido en comparación con el cuerpo tubular 6130 relativamente flexible del retractor 6100, de modo que el anillo exterior 6120 pueda aplicarse de forma hermética un dispositivo de acceso tal como una tapa. Con referencia a la Figura 5B, se ilustra una vista en perspectiva del retractor con un corte parcial del anillo exterior 6120. En la realización ilustrada, el anillo exterior 6120 incluye una ranura anular 6122 formada en el mismo, en la que está dispuesto un elemento de refuerzo 6124. El elemento de refuerzo 6124 puede consistir en un elemento metálico tal como un alambre con forma de anillo. Por ejemplo, el elemento de refuerzo 6124 puede consistir en un anillo de acero inoxidable colocado dentro de la ranura 6122 durante la fabricación del retractor 6100. El número de refuerzo 6124 puede consistir en un elemento no metálico inyectable. Por ejemplo, se puede inyectar un material de polímero o policarbonato cargado de vidrio en la ranura 6122 durante la fabricación del retractor 6100.
Aunque las realizaciones ilustradas del retractor 6100 incluyen un elemento de refuerzo para mejorar la rigidez del anillo exterior 6120, en otras realizaciones, el retractor 6100 puede formarse en un proceso de moldeo de múltiples pasos. Por ejemplo, en algunos ejemplos, se forma un segmento interno del retractor definido por el cuerpo tubular 6130 y la pestaña 6110 en una operación de moldeo a partir de un material flexible, y se forma un segmento externo del retractor 6100 definido por el segmento de embudo 6140 y el anillo exterior 6120 en otra operación de moldeo a partir de un material relativamente rígido tal como un material de policarbonato u otro material adecuado.
Continuando con la referencia a la Figura 5B, el ejemplo ilustrado incluye una ranura continua generalmente anular. En otros ejemplos, cada una de una pluralidad de cavidades no contiguas puede recibir uno de una pluralidad de elementos de refuerzo. Además, en algunos ejemplos, el anillo exterior puede incluir dos o más ranuras concéntricas generalmente anulares, cada una de las cuales reciba un elemento de refuerzo correspondiente.
Se pueden usar varios tipos de pestañas para ayudar a asegurar el retractor en el orificio del cuerpo. Un ejemplo de un retractor 6100 del dispositivo de acceso por orificio natural, ilustrado en la Figura 6A, puede estar adaptado para su uso en una operación quirúrgica transvaginal. El retractor 6100 comprende una pestaña de oclusión 6111, un anillo exterior o proximal 6120, y un cuerpo tubular 6130 y un segmento de embudo 6140 que se extiende y se acopla entre la pestaña de oclusión 6111 y el anillo exterior 6120. La pestaña de oclusión 6111 es semirrígida, con un diámetro de aproximadamente 5 a 10 cm (2 pulgadas a 4 pulgadas). Cuando se inserta en el orificio de la vagina, por ejemplo, la pestaña está bajo compresión desde las paredes del canal vaginal, creando una obturación para ayudar en el mantenimiento de la insuflación. En algunos ejemplos, la pestaña de oclusión tiene "forma de copa" con un reborde 6109 circular que circunscribe un canal 6107, lo que proporciona suficiente flexibilidad para permitir que la pestaña 6111 se flexione para acomodarse a diferentes anatomías mientras se mantiene una obturación.
Con referencia a la Figura 6C, se muestra una vista lateral de un ejemplo de un retractor 6100 para su uso en el sistema de dispositivo de acceso por orificio natural que tiene una pestaña diferente. En este ejemplo, el retractor 6100 se muestra con una pestaña de compresión 6112. La pestaña de compresión 6112 tiene aproximadamente de 5 a 10 cm (2 pulgadas a 4 pulgadas) de diámetro y está dispuesta alrededor del retractor distal respecto del anillo exterior o proximal 6120. La distancia entre la pestaña de compresión y el anillo exterior está diseñada para ser menor que el grosor de los tejidos que comprenden la abertura del orificio natural. En el caso de la abertura vaginal, la distancia es de aproximadamente 0,25 a 1,25 cm (0,1 pulgadas a 0,5 pulgadas). Esto crea una fuerza de compresión en el tejido entre la pestaña y el anillo exterior del retractor. Esta fuerza y la geometría "en forma de copa" de la pestaña (véase la Figura 6D) ocluyen la vagina y sirven para evitar un desprendimiento. Se pueden usar sujetadores de sutura 6160 para mitigar los desprendimientos.
Con referencia a la Figura 6E, se muestra una vista en perspectiva de un retractor 6100 para su uso en el sistema de dispositivo de acceso por orificio natural que tiene aún otra disposición de pestaña. En este ejemplo, el retractor 6100 se muestra con un cono de refuerzo 6113. Se puede añadir al retractor el cono de refuerzo de polímero termoestable blando o de elastómero termoplástico (que se estrecha con un diámetro máximo de aproximadamente 2 pulgadas a aproximadamente 4 pulgadas (5 a 10 cm) para su uso en la vagina). Durante el uso, el retractor avanza hacia el interior del orificio del cuerpo, como una vagina, mientras que el cono de refuerzo sirve como un tope para ocluir la vagina en forma externa. El cono de refuerzo puede ser fijo o móvil a lo largo del cuerpo tubular 6130 del retractor 6100. Los sujetadores de sutura 6160 evitan que el retractor se desprenda y mantienen la compresión del cono de refuerzo contra la abertura del orificio. El diseño puede incluir opcionalmente una pestaña similar a otras descritas en la presente memoria.
Con referencia a las Figuras 6F y 6G, se muestra una vista lateral de un retractor de acuerdo con la presente invención, y para su uso en el sistema de dispositivo de acceso por orificio natural, que tiene una pestaña diferente. En esta realización, el retractor se muestra con una particularidad de expansión mecánica (un "globo mecánico") 6114. El globo mecánico comprende una serie de brazos 6105 circunferencialmente alrededor del canal 6130 que corren, cada uno, a lo largo del canal 6130. Los brazos están unidos en un extremo proximal a un primer anillo 6103 y en un extremo distal a un segundo anillo 6101. El primer anillo 6103 se puede mover a lo largo de la longitud del canal 6130, mientras que el segundo anillo está fijo en o cerca del extremo distal del canal 6130. Un tercer anillo móvil 6102, dispuesto alrededor del canal tubular proximal al primer anillo, puede avanzar hacia el extremo distal del canal, aplicando a los brazos una carga que hace que estos se abran hacia fuera para adoptar una forma de globo, como se muestra en la Figura 6G. Los brazos ejercen una fuerza sobre la anatomía del orificio natural, lo que hace que el retractor quede anclado en su lugar sin dañar el tejido circundante.
En algunas realizaciones, el tercer anillo móvil está roscado a lo largo de su superficie interior y está adaptado para acoplarse con las roscas dispuestas alrededor del canal. Véase la Figura 6G. En otras realizaciones, se puede usar un mecanismo de trinquete para mover el tercer anillo a lo largo del canal.
El anillo deslizante puede ser de cualquier material rígido o semirrígido, plástico o metálico, mientras que los brazos pueden ser de un metal o plástico semirrígido suficientemente flexible para abrirse hacia fuera bajo una carga. Alternativamente, los brazos pueden ser de un material rígido con una unión articulada ubicada aproximadamente a la mitad de la longitud de cada brazo, facilitando un ensanchamiento similar.
El globo mecánico tiene un diámetro de aproximadamente 5 cm (2 pulgadas) a aproximadamente 10 cm (4 pulgadas) y está dispuesto alrededor del cuerpo tubular en el extremo distal del retractor. El globo mecánico puede recubrirse con un material no poroso y flexible para permitir la oclusión y evitar el desprendimiento cuando está expandido, o no recubierto para servir únicamente de fijación. La cantidad de expansión puede ser variable para adaptarse a diferentes anatomías. El elemento inicialmente no está expandido para facilitar la inserción y luego se expande, según sea necesario.
En algunas realizaciones, el globo mecánico se puede usar en combinación con una pestaña de compresión como se muestra en la Figura 6C. En esta realización, la pestaña de compresión está dispuesta alrededor del cuerpo tubular proximal al globo mecánico y ayuda a obturar el retractor dentro del orificio natural. En una realización alternativa, el globo mecánico puede usarse en combinación con un cono de refuerzo, como se muestra en la Figura 6E. El cono de refuerzo actuará para obturar el retractor dentro del orificio, mientras que el globo mecánico ayuda a anclarlo.
Si bien ciertas realizaciones se han mostrado y descrito particularmente con referencia a las realizaciones de ejemplo de las mismas, los expertos en la técnica entenderán que se pueden realizar diversos cambios en la forma y en los detalles sin apartarse del alcance de las mismas, como se define en las siguientes reivindicaciones.
Claims (6)
1. Un sistema (6100) de puerta de acceso quirúrgico para realizar operaciones quirúrgicas en un orificio natural que comprende:
un anillo exterior (6120), cuyo anillo exterior está configurado para disponerse cerca del orificio natural del paciente; y
un cuerpo tubular (6130) que tiene un eje geométrico longitudinal, un extremo proximal y un extremo distal, en el que el extremo proximal del cuerpo tubular está acoplado al anillo exterior (6120); una serie de brazos (6105) dispuestos a lo largo del eje longitudinal del cuerpo tubular, teniendo cada brazo un extremo proximal unido a un primer anillo (6103) y un extremo distal unido a un segundo anillo, en el que el segundo anillo (6101) está fijo al cuerpo tubular;
caracterizado por que comprende, además:
un globo mecánico (6114) dispuesto alrededor del cuerpo tubular (6130), comprendiendo el globo mecánico (6114) dicha serie de brazos (6105) dispuestos a lo largo del eje longitudinal del cuerpo tubular (6130); y un tercer anillo dispuesto alrededor del cuerpo tubular proximal al primer anillo, estando el tercer anillo (6102) adaptado para moverse a lo largo del cuerpo tubular (6130) para acoplarse al primer anillo (6103) y empujar el primer anillo (6103) hacia el extremo distal del cuerpo tubular (6130), aplicando así una carga a los brazos (6105) y haciendo que se abran desde el cuerpo tubular (6130).
2. La puerta de acceso quirúrgico de acuerdo con la reivindicación 1, en la que los brazos (6105) son de un material semirrígido.
3. La puerta de acceso quirúrgico de acuerdo con la reivindicación 1, en la que cada uno de los brazos (6105) comprende, además, una unión articulada a lo largo de la longitud del brazo.
4. La puerta de acceso quirúrgico de acuerdo con la reivindicación 1, que comprende, además, una pestaña (6109) dispuesta alrededor del cuerpo tubular, proximal al globo mecánico.
5. La puerta de acceso quirúrgico de acuerdo con la reivindicación 1, que comprende además un refuerzo (6113) dispuesto alrededor del cuerpo tubular, próximo al globo mecánico.
6. El sistema de puerta de acceso quirúrgico de acuerdo con la reivindicación 1, en el que el extremo proximal del cuerpo tubular comprende un segmento de embudo.
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