ES2422332B1 - Dispositivo quirúrgico - Google Patents

Dispositivo quirúrgico Download PDF

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ES2422332B1
ES2422332B1 ES201230330A ES201230330A ES2422332B1 ES 2422332 B1 ES2422332 B1 ES 2422332B1 ES 201230330 A ES201230330 A ES 201230330A ES 201230330 A ES201230330 A ES 201230330A ES 2422332 B1 ES2422332 B1 ES 2422332B1
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blade
tightening
staples
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ES2422332A1 (es
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Iv�n Jes�s ARTEAGA GONZ�LEZ
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Priority to US13/786,380 priority patent/US20130248578A1/en
Priority to EP20130382073 priority patent/EP2636377A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07228—Arrangement of the staples

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Dispositivo quirúrgico, apto para acoplarse al mango (5) de una endograpadora con un medio de accionamiento para un canal (1) de apriete y un yunque (2) de apriete, donde el canal (1) de apriete incluye un cartucho (3) con una cuchilla (4) y con al menos una línea de impulsores (8) para las grapas a cada lado de la cuchilla (4), y donde el yunque (2) comprende una ranura (6) para la cuchilla (4) y al menos una línea de alvéolos (7) a cada lado de dicha cuchilla (4), siendo dichas líneas de alvéolos (7) correspondientes con las líneas de impulsores (8) para las grapas, donde el número de líneas de impulsores (8) y el número de líneas de alvéolos (7) para las grapas es diferente a cada lado de la cuchilla (4) y la ranura (6) respectivamente.

Description

Dispositivo quirúrgico
OBJETO DE LA INVENCIÓN
La presente invención trata de un dispositivo quirúrgico para endograpadora que aporta más seguridad en el borde de resecci�n que permanece en el paciente, y suprimiendo grapas innecesarias en el borde a eliminar. Para ello, el dispositivo quirúrgico de la invención comprende un canal de apriete y un yunque de apriete de localización asimétrica o lateral, de manera que existe mayor número de líneas de impulsores de grapas y alvéolos a un lado de la cuchilla y ranura respectivamente, que en el lado opuesto.
ANTECEDENTES DE LA INVENCIÓN
Existen en el estado de la técnica una pluralidad de dispositivos de grapado y sección de tejido post-operatorio, llamados comúnmente grapadoras quirúrgicas o endograpadoras.
Una grapadora quirúrgica es un dispositivo m�dico que se utiliza para colocar grapas quirúrgicas en los procesos u operaciones que precisen resecci�n de vísceras.
Las grapadoras quirúrgicas han ido desarrollándose para aportar mayor seguridad y rapidez en la resecci�n de vísceras, as� como en la realización de anastomosis, mejorando los resultados de las suturas manuales tradicionales, pues la fuga y sangrado postoperatorio de la línea de grapas son las causas más frecuentes de complicaciones, incluida la muerte de los pacientes.
El desarrollo de las grapadoras quirúrgicas aporta ventajas en velocidad de la operación, precisión y uniformidad en la realización de los procedimientos, lo que lo convierte en un elemento imprescindible en la sala de operaciones.
Las endograpadoras o grapadoras quirúrgicas más utilizadas actualmente, tienen la doble función de cortar y grapar. Para la realización de estas funciones, disponen de una serie de filas de grapas dispuestas longitudinalmente que se colocan a ambos lados de un surco central por donde se desplaza una cuchilla que va cortando el tejido a la vez que se grapan los extremos del corte. Estos instrumentos facilitan de esta forma los procedimientos quirúrgicos en términos de rapidez, seguridad y uniformidad, evitando los errores técnicos de las suturas manuales.
El incremento de líneas de suturas o filas de grapas, que ha pasado de cuatro a seis en los últimos modelos de endograpadoras, tres hileras a cada lado, aumenta la seguridad en el sellado de los tejidos, disminuyendo el número de episodios de sangrado o fuga.
Sin embargo, las endograpadoras lineales est�n especialmente diseñadas para cirugía laparosc�pica y presentan un ancho límite de doce milímetros para que sea posible su introducción a través de los puertos de entrada, utilizados en esta vía de abordaje, de doce milímetros de espesor como máximo. Disponen de un cabezal donde se alinean un número simétrico o equivalente de filas de grapas, a ambos lados del canal por el que discurre la cuchilla que corta. De esta forma, una vez seccionados, los tejidos quedan herméticamente cerrados a ambos lados del corte de igual manera, con dos o tres líneas de grapas como máximo según el modelo de endograpadora que se utilice. Este mecanismo es especialmente útil en la cirugía de reconstrucción intestinal, es decir, cuando se realiza la unión o anastomosis entre dos vísceras, porque interesa una unión estanca a ambos lados del corte. Sin embargo, en la cirugía de resecci�n, como podría ser la gastrectom�a vertical, realizada para el tratamiento de la Obesidad Patológica, uno de los lados del corte va a corresponder al borde del remanente gástrico resecado, que se eliminar� del paciente. Por lo tanto, este borde de resecci�n no es necesario que quede reforzado con dos o tres líneas de grapas, pues se va a eliminar. Mientras, el borde de resecci�n del estómago que se queda en el paciente y que va a ser el lugar de potenciales complicaciones, sólo va a tener como máximo tres líneas de grapas.
Esto se traduce en que las grapadoras quirúrgicas o endograpadoras actuales, cuando se utilizan para la cirugía resectiva, desaprovechan sistemáticamente, la mitad de las filas de grapas dispuestas a un lado del corte, como consecuencia de que son aparatos, conceptualmente fabricados para la realización de anastomosis intestinales. Por otro lado, este mecanismo también funciona adecuadamente para procedimientos en los que se necesita la misma seguridad en los dos extremos de la sección, por ejemplo, en la hemostasia de un vaso de gran calibre. Sin embargo, en los procedimientos quirúrgicos que implican la extirpaci�n de un órgano completo o parcialmente, como estómago o pulmón, la disposición de un número equivalente y simétrico de líneas de sutura a los dos lados del corte es incoherente, debido a que refuerza por igual el borde de resecci�n que permanece y el que se extirpa del organismo del paciente.
ES 2 422 332 Al
DESCRIPCI�N DE LA INVENCIÓN
La invención que se propone resuelve de forma plenamente satisfactoria la problem�tica anteriormente expuesta. Se trata de dispositivo quirúrgico para endograpadora, provisto de un cabezal con canal de sección desplazado lateralmente, disponiendo de un mayor número de filas de grapas a un lado que al otro lado del corte.
De este modo, se consigue que el borde de resecci�n de la víscera que se corta y que va a permanecer en el paciente disponga de más líneas de grapas, mientras se disponen menos líneas de grapas en el borde de resecci�n que se va a extraer del paciente y que por tanto no necesita estar reforzado. Por ejemplo, en una endograpadora de seis filas de grapas y tamaño estándar de 12 milímetros, se consigue en el borde que permanece en el paciente hasta cinco líneas de grapas, mientras el borde que se extrae tendría únicamente una línea de grapas. De esta manera, se aumenta sustancialmente la seguridad del corte, disminuyendo significativamente los episodios de ruptura y sangrado de la línea de grapado y por lo tanto de muerte postoperatoria.
La grapadora quirúrgica propuesta permite utilizar en un cabezal con la misma anchura, un mayor número de grapas en el extremo de sección que nos interese aportar una mayor seguridad, desplazando la cuchilla y la ranura a un lado de la línea central longitudinal del canal y del yunque de apriete.
Por tanto, gracias a esta configuración asimétrica, la invención propuesta, que permite un mayor número de líneas de grapas en un lado del corte, aporta más seguridad, además de permitir la posibilidad de diseñar instrumentos de menor tamaño que los actuales.
DESCRIPCI�N DE LOS DIBUJOS
Para complementar la descripción que se est� realizando del objeto de la invención y para ayudar a una mejor comprensión de las características que lo distinguen, se acompaña la presente memoria descriptiva, como parte integrante de la misma, de un juego de planos, en los que con carácter ilustrativo y no limitativo se ha representado lo siguiente:
La Figura 1.- muestra una vista de una posible realización preferente de la invención, estando acoplada al mango de una endograpadora.
La Figura 2.- muestra el canal de apriete del dispositivo quirúrgico, en vista en alzado y planta, viendo en la planta la disposición de las diferentes líneas de grapas, y donde la cuchilla no se encuentra en el centro del canal de apriete.
La Figura 3.- muestra el yunque de apriete del dispositivo quirúrgico de la invención, en vista en alzado y planta, donde en la planta se observa la disposición de los alvéolos para las grapas y la ranura para la cuchilla.
REALIZACI�N PREFERENTE DE LA INVENCIÓN
La presente invención describe un dispositivo quirúrgico, apto para acoplarse al mango (5) de una endograpadora que comprende un medio de accionamiento, que aporta ventajas respecto a los dispositivos actuales.
El medio de accionamiento de la endograpadora actúa sobre un canal (1) de apriete y un yunque (2) de apriete, donde el canal (1) de apriete incluye un cartucho (3) con una cuchilla (4) y con al menos una línea de impulsores (8) para las grapas a cada lado de la cuchilla (4). El yunque (2) de apriete comprende una ranura (6) para la cuchilla (4) y al menos una línea de alvéolos (7) a cada lado de dicha cuchilla (4). De este modo, el número de líneas de impulsores (8) para las grapas y líneas de alvéolos (7) para dichas grapas es el mismo, coincidiendo en el apriete las grapas en los alvéolos (7).
Para conseguir el objeto de la invención, donde el borde de resecci�n que permanece en el paciente disponga de mayor estanqueidad y seguridad que el borde que se elimina, el número de grapas que se disponga en este borde de resecci�n del paciente ha de ser mayor. Para ello, el número de líneas de impulsores (8) de grapas, as� como el número de líneas de alvéolos (7) para las grapas es diferente a cada lado de la cuchilla (4) y la ranura (6) respectivamente.
De este modo, se consigue un dispositivo que disponga mayor número de grapas en el lado de resecci�n que permanece en el paciente, aumentando seguridad y estanqueidad.
Adem�s, se permite el diseño de dispositivos de menor tamaño para el mismo número de filas de impulsores (8) de grapas, pues se desplaza a un lado la cuchilla (4) y la ranura (6), pudiendo aumentar el número de líneas de impulsores (8) de grapas del lado deseado sin necesidad de aumentar el tamaño del dispositivo de grapado. Es decir, tanto la cuchilla (4) como la ranura (6) se encuentran desplazadas a un lado de la línea central longitudinal (L,
L’) del canal (1) y del yunque (2) de apriete.
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Por tanto, es evidente que ser� deseado que el número de líneas de impulsores (8) para las grapas y alvéolos sea mayor para el lado del grapado del borde de resecci�n que permanece en el paciente que para el lado que se elimina, ahorrando costes en la parte desechada y aumentando la estanqueidad y seguridad en el borde de resecci�n del paciente.
ES 2 422 332 Al

Claims (3)

  1. REIVINDICACIONES
    1.- Dispositivo quirúrgico, apto para acoplarse al mango (5) de una endograpadora con un medio de accionamiento para un canal (1) de apriete y un yunque (2) de apriete, que comprende un medio de accionamiento de un canal (1) 5 de apriete y un yunque (2) de apriete, donde el canal (1) de apriete incluye un cartucho (3) con una cuchilla (4) y con al menos una línea de impulsores (8) para las grapas a cada lado de la cuchilla (4), y donde el yunque (2) comprende una ranura (6) para la cuchilla (4) y al menos una línea de alvéolos (7) a cada lado de dicha cuchilla (4), siendo dichas líneas de alvéolos (7) correspondientes con las líneas de impulsores (8) para las grapas, caracterizado porque el número de líneas de impulsores (8) y el número de líneas de alvéolos (7) para las grapas
    10 es diferente a cada lado de la cuchilla (4) y la ranura (6) respectivamente.
  2. 2.- Dispositivo quirúrgico, según reivindicación 1, caracterizado porque tanto la cuchilla (4) como la ranura (6) se encuentran desplazadas a un lado de la línea central longitudinal (L, L’) del canal (1) y del yunque (2) de apriete.
    15 3.- Dispositivo quirúrgico, según reivindicaciones anteriores, caracterizado porque el número de líneas de impulsores (8) para las grapas y número de líneas de alvéolos (7) es mayor para el lado del grapado del borde de resecci�n que permanece en el paciente.
    ES 2 422 332 Al
    L
    2
    OFICINA ESPAÑOLA DE PATENTES Y MARCAS
    N.� solicitud: 201230330
    ESPA�A
    Fecha de presentación de la solicitud: 05.03.2012
    Fecha de prioridad:
    INFORME SOBRE EL ESTADO DE LA TECNICA
    DOCUMENTOS RELEVANTES
    Categoria
    @ Documentos citados Reivindicaciones afectadas
    X A A US 2011089221 A1 (MASIAKOS et al.) 21.04.2011, párrafos [26-32]; figuras 2-3,9. US 4848637 A (PRUITT) 18.07.1989, columna 2, líneas 36-39; columna 5, líneas 36-42; figura 6. US 3795034 A (STREKOPYTOV et al.) 05.03.1974, columna 4, línea 60 – columna 5, línea 10; figuras 1-2. 1-3 1-3 1,3
    Categoría de los documentos citados X: de particular relevancia Y: de particular relevancia combinado con otro/s de la misma categoría A: refleja el estado de la técnica O: referido a divulgación no escrita P: publicado entre la fecha de prioridad y la de presentación de la solicitud E: documento anterior, pero publicado después de la fecha de presentación de la solicitud
    El presente informe ha sido realizado � para todas las reivindicaciones � para las reivindicaciones n�:
    Fecha de realizaci6n del informe 27.08.2013 Examinador J. Cuadrado Prados Pagina 1/4
    INFORME DEL ESTADO DE LA TÉCNICA
    N� de solicitud: 201230330
    Documentaci�n mínima buscada (sistema de clasificación seguido de los símbolos de clasificación) A61B Bases de datos electrónicas consultadas durante la búsqueda (nombre de la base de datos y, si es posible, términos de
    b�squeda utilizados) INVENES, EPODOC, WPI, PAJ.
    Informe del Estado de la Técnica Página 2/4
    OPINION ESCRITA
    N� de solicitud: 201230330
    Fecha de Realización de la Opinión Escrita: 27.08.2013 Declaraci6n
    Novedad (Art. .1 LP 11/198 )
    Reivindicaciones Reivindicaciones 2 1, 3 SI NO
    Actividad inventiva (Art. 8.1 LP11/198 )
    Reivindicaciones Reivindicaciones 1-3 SI NO
    Se considera que la solicitud cumple con el requisito de aplicación industrial. Este requisito fue evaluado durante la fase de examen formal y técnico de la solicitud (Artículo 31.2 Ley 11/1986).
    Base de la Opini6n.
    La presente opinión se ha realizado sobre la base de la solicitud de patente tal y como se publica.
    Informe del Estado de la Técnica Página 3/4
    OPINION ESCRITA
    N� de solicitud: 201230330
    1. Documentos considerados.-
    A continuación se relacionan los documentos pertenecientes al estado de la técnica tomados en consideración para la realización de esta opinión.
    Documento
    Numero Publicaci6n o Identificaci6n Fecha Publicaci6n
    D01
    US 2011089221 A1 (MASIAKOS et al.) 21.04.2011
  3. 2. Declaraci6n motivada segun los articulos 29. y 29.7 del Reglamento de ejecuci6n de la Ley 11/198 , de 20 de marzo, de Patentes sobre la novedad y la actividad inventiva; citas y explicaciones en apoyo de esta declaraci6n
    La solicitud se refiere a un dispositivo quirúrgico para una endograpadora, provisto de un cabezal con un canal de sección desplazado lateralmente, de manera que se disponen un mayor número de filas de grapas a un lado que al otro lado del corte.
    El objeto de la invención que se deriva de la reivindicaci6n principal de la solicitud se puede considerar que carece de novedad ya que el documento D01 citado en el Informe sobre el estado de la Técnica (IET), divulga un objeto idéntico al que se desprende de la redacción de la reivindicación.
    En efecto, en el documento D01 (ver partes citadas en el IET) se describen (las referencias entre parentesis se aplican a ese documento) un:
    -
    Dispositivo quirúrgico, apto para acoplarse al mango (12, 14) de una endograpadora con un medio de accionamiento (parrafo 27, f inal) para un canal (20) de apriete y un yunque (30) de apriete, que comprende un medio de accionamiento de un canal (20) de apriete y un yunque (30) de apriete, donde el canal (20) de apriete incluye un cartucho (parrafo 29) con una cuchilla (34, figura 2) y con al menos una línea de impulsores (328, 321, en figuras 7-8) para las grapas (24, 324, parrafo 3@) a cada lado de la cuchilla (34), y donde el yunque (30) comprende una ranura (parrafo 32) para la cuchilla (34) y al menos una línea de alvéolos (parrafo 31) a cada lado de dicha cuchilla (34), siendo dichas líneas de alvéolos (parrafo 31) correspondientes con las líneas de impulsores (28, 328) para las grapas, y en el que el número de líneas de impulsores (28, 128, 328) y el número de líneas de alvéolos (parrafo 31) para las grapas es diferente (ver figuras 2-3, parrafo 32) a cada lado de la cuchilla (34) y la ranura (parrafo 32) respectivamente.
    Aunque los alveolos y la ranura para la cuchilla del yunque no se muestran expresamente ni se referencian en las figuras, se consideran incluidos inequívocamente de forma implícita a partir de lo indicado en los párrafos 31 y 32. As� pues, el documento D01 contiene todas las características técnicas de la reivindicación primera, por lo que esta no es nueva, y por lo tanto no cumple los requerimientos del artículo 6.1 de la Ley de Patentes (LP 11/1986).
    El objeto de la segunda reivindicaci6n, dependiente de la principal, se considera carente de actividad inventiva a partir del propio documento D01, ya que en el mismo se anticipa un modo de realización (ver figuras @ y , parrafo 39) en el que
    “tanto la cuchilla como la ranura se encuentran desplazadas a un lado de la línea central longitudinal del canal y del yunque de apriete”. Aunque en esos modos concretos de realización (figuras @ y ) no se muestra que el “número de líneas de impulsores y el número de líneas de alvéolos para las grapas sea diferente a cada lado de la cuchilla y la ranura respectivamente”, tal como se limita en la reivindicación principal, parece claro que cualquier experto en la materia consideraría la posibilidad de llegar al objeto de esta segunda reivindicación sin un esfuerzo inventivo, esto es, llegar a un modo de realización en el que el número de líneas de impulsores y de alveolos sea diferente a cada lado de la cuchilla y en el que a su vez esta cuchilla se encuentre desplazada a un lado de la línea central longitudinal. El propio párrafo 29 de D01 da un indicio para considerar esta posibilidad, al indicar que se puede incluir un número de filas diferentes, dando la solución de la figura 6 solo a modo de ejemplo.
    El objeto de la tercera reivindicaci6n, al depender de la principal, se considera que carece de novedad a la vista de D01, ya que en este documento se anticipa también la característica aquí incluida de que “el número de líneas de impulsores para las grapas y número de líneas de alvéolos es mayor para el lado del grapado del borde de resecci�n que permanece en el paciente” (ver por ejemplo parrafos 2 , 32, 33, figura 9).
    Informe del Estado de la Técnica Página 4/4
ES201230330A 2012-03-05 2012-03-05 Dispositivo quirúrgico Expired - Fee Related ES2422332B1 (es)

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ES201230330A ES2422332B1 (es) 2012-03-05 2012-03-05 Dispositivo quirúrgico
US13/786,380 US20130248578A1 (en) 2012-03-05 2013-03-05 Surgical device
EP20130382073 EP2636377A1 (en) 2012-03-05 2013-03-05 Surgical device

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ES2422332B1 true ES2422332B1 (es) 2014-07-01

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US9072535B2 (en) 2011-05-27 2015-07-07 Ethicon Endo-Surgery, Inc. Surgical stapling instruments with rotatable staple deployment arrangements
US11998198B2 (en) 2004-07-28 2024-06-04 Cilag Gmbh International Surgical stapling instrument incorporating a two-piece E-beam firing mechanism
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