ES2377641T3 - Introductor de instrumento - Google Patents

Introductor de instrumento Download PDF

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Publication number
ES2377641T3
ES2377641T3 ES03728374T ES03728374T ES2377641T3 ES 2377641 T3 ES2377641 T3 ES 2377641T3 ES 03728374 T ES03728374 T ES 03728374T ES 03728374 T ES03728374 T ES 03728374T ES 2377641 T3 ES2377641 T3 ES 2377641T3
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distal end
instrument
end portion
introducer
surgical instrument
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Bruce Jankowski
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Covidien LP
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Tyco Healthcare Group LP
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis, e.g. in a single operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/31—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the rectum, e.g. proctoscopes or sigmoidoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis, e.g. in a single operation
    • A61B17/1155—Circular staplers comprising a plurality of staples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3498—Valves therefor, e.g. flapper valves, slide valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/685—Elements to be fitted on the end of screws or wires, e.g. protective caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00296—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means mounted on an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B2017/3441—Cannulas with means for changing the inner diameter of the cannula, e.g. expandable with distal sealing means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0801—Prevention of accidental cutting or pricking
    • A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/40—Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment

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

Abstract

Un introductor (10) de instrumento para facilitar la inserción de un instrumento quirurgico (S) dentro de una cavidad o una abertura corporal de un paciente protegiendo el tejido que rodea a la abertura corporal contra el trauma causado por las superficies extremas distales del instrumento, comprendiendo el introductor: una porción de envoltura tubular (12) que define un lumen (18) a traves de ella, teniendo la porción de envoltura tubular un extremo proximal abierto para recibir el instrumento fuera de la abertura corporal, y un extremo distal; y una porción extrema distal (14) fijada al extremo distal (12a) de la porción de envoltura tubular, incluyendo la porción extrema distal una pared extrema distal (20), incluyendo ademas la porción extrema distal una pared lateral anular (22) pendiente del borde terminal exterior de la pared extrema distal, caracterizado porque la pared extrema distal de la porción extrema distal limita una abertura circular abierta (26) formada en ella e incluye una superficie interior para hacer contacto con el extremo distal del instrumento quirurgico, en el que la porción extrema distal esta configurada y adaptada para facilitar el paso de un instrumento quirurgico a traves de la abertura;y en el que la pared extrema distal de la porción extrema distal (14) esta formada para definir un bolsillo (30) extendido en dirección distal que tiene un diametro menor que el diametro de la pared lateral anular, en el que la abertura esta formada en el bolsillo.

Description

Introductor de instrumento
Antecedentes
1.
Campo tecnico�
La presente exposici6n se refiere a introductores o manguitos protectores de instrumentos y, mas particularmente, a vainas protectoras nuevas configuradas para facilitar la introducci6n de instrumentos quirurgicos dentro de una cavidad o una abertura corporal de un paciente.
2.
Antecedentes de tecnica relacionada
Los instrumentos quirurgicos configurados para uso a distancia dentro del cuerpo de un paciente definen tipicamente un eje longitudinal central que incluye una porci6n extrema distal y una porci6n extrema proximal. La porci6n extrema distal del instrumento quirurgico puede incluir configuraciones que tienen caras romas o redondeadas y/o en ciertos casos incluir subconjuntos mas agudos que incluyen cuchillas electroquirurgicas o mecanicas para cortar asi como grapas para sujetar porciones de tejido. Tipicamente, las porciones extremas distales y, en particular, las superficies extremas distales de estos instrumentos quirurgicos son tales que pueden causar irritaci6n o trauma en el tejido que rodea a la abertura del cuerpo a traves de la cual el instrumento ha de ser insertado. Como un resultado de la complejidad mecanica de estos instrumentos quirurgicos, las porciones extremas distales de estos instrumentos han sido provistos de una envoltura o cubierta que puede encerrar parcial o totalmente la porci6n extrema distal del instrumento quirurgico.
Por ejemplo, actualmente, diversos instrumentos quirurgicos intra-anales, tales como grapadoras quirurgicas anastom6ticas intraluminales, requieren la inserci6n dentro del colon o intestino a traves del ano. En ciertas realizaciones, estas grapadoras quirurgicas tienen porciones de yunques de grapas montadas separablemente en un extremo distal de ellas. Generalmente, la grapadora quirurgica es insertada con la porci6n de yunque unida, sin embargo, ciertos procedimientos quirurgicos requieren que la grapadora quirurgica sea insertada dentro del colon o intestino a traves del ano con la porci6n de yunque quitada.
Tipicamente, en casos donde la grapadora quirurgica ha de ser insertada dentro del colon o intestino del paciente con la porci6n de yunque montada en un extremo distal de ella, La porci6n de yunque es ahusada hacia dentro hacia la punta y formada para tener un extremo atraumatico, facilitando asi la inserci6n del extremo distal del instrumento quirurgico dentro del colon o intestino del paciente. Sin embargo, en casos donde la grapadora quirurgica ha de ser insertada dentro del colon o intestino sin la porci6n de yunque montada en el extremo distal de ella, el extremo distal sustancialmente cuadrado o no c6nico del instrumento quirurgico puede causar irritaci6n y trauma en el tejido circundante.
Asi, existe una necesidad de un introductor de instrumento en la forma de una vaina, cuyo introductor de instrumento facilita el paso del instrumento quirurgico al interior del cuerpo del paciente y que puede ser adaptado para ser montado separablemente en el extremo distal del instrumento quirurgico o ser usado como un dispositivo separado adaptado para ser situado al menos parcialmente dentro del cuerpo del paciente (o sea, dentro del ano) y en el que el instrumento quirurgico es situado posteriormente dentro del introductor de instrumento para facilitar la inserci6n del instrumento quirurgico dentro del cuerpo del paciente. El documento US-A-5792074 expone un cateter para introducir un cateter de muestreo. La forma en dos partes de la reivindicaci6n 1 esta basada en este documento.
Sumario
La presente exposici6n se refiere a introductores de instrumentos configurados para facilitar la introducci6n de instrumentos quirurgicos dentro de una cavidad o una abertura corporal de un paciente. La presente invenci6n es definida en la reivindicaci6n 1 siguiente, y las reivindicaciones dependientes estan dirigidas a caracteristicas 6ptimas y preferidas de la invenci6n. El introductor de instrumento incluye una porci6n de envoltura tubular que define un lumen a traves de ella, teniendo la porci6n de envoltura tubular un extremo proximal y un extremo distal y una porci6n extrema distal sujeta al extremo distal de la porci6n de envoltura tubular, incluyendo la porci6n extrema distal una pared extrema distal configurada y adaptada para facilitar el paso de un instrumento quirurgico a traves de ella.
La porci6n extrema distal incluye una pared lateral anular pendiente de un borde de terminal exterior de la pared extrema distal. Preferiblemente, la porci6n extrema distal es fabricada de un material elastomerico. La pared extrema distal de la porci6n extrema distal incluye una abertura formada en ella, en la que la abertura esta alineada de modo preferiblemente coaxial con un eje longitudinal central de la porci6n de envoltura tubular.
En una realizaci6n, la porci6n extrema distal esta sujeta al extremo distal de la porci6n de envoltura tubular tal que la pared lateral anular solapa al menos parcialmente el extremo distal de la porci6n de envoltura tubular. En otra realizaci6n, la porci6n extrema distal esta sujeta al extremo distal de la porci6n de envoltura tubular tal que la pared lateral anular solapa completamente el extremo distal de la porci6n de envoltura tubular. En otra realizaci6n mas, un borde terminal proximal de la pared lateral anular de la porci6n extrema distal esta sujeto al borde terminal distal del
extremo distal de la envoltura tubular. La porci6n extrema distal es fijada al extremo distal de la envoltura tubular por fusi6n, sobremoldeo, encolado y/o ligaz6n.
La porci6n de envoltura tubular es fabricada preferiblemente de polipropileno. En una realizaci6n, el introductor de instrumento incluye una pestana extendida radialmente hacia fuera desde el extremo proximal de la porci6n de envoltura tubular.
La pared extrema distal de la porci6n extrema distal puede ser provista de una regi6n de resistencia debilitada. La regi6n de resistencia debilitada puede incluir lineas de estrias, perforaciones, reticulado y/o espesor reducido. La pared extrema distal de la porci6n extrema distal esta formada para definir un bolsillo extendido en direcci6n distal. El bolsillo tiene un diametro menor que el diametro de la pared lateral anular.
En una realizaci6n de la presente invenci6n, el introductor de instrumento incluye una envoltura cilindrica alargada hueca que incluye una porci6n extrema distal que termina en un borde distal y una porci6n extrema proximal, definiendo la envoltura cilindrica un eje longitudinal central, y una caperuza elastomerica fijada a la porci6n extrema distal de la envoltura cilindrica, incluyendo la caperuza una pared extrema distal que tiene un borde terminal exterior y una pared lateral anular pendiente del borde terminal exterior de ella. La pared extrema distal incluye una abertura formada en ella, en la que el centro de la abertura esta alineado coaxialmente con el eje longitudinal central. La envoltura cilindrica esta configurada y adaptada para recibir un instrumento quirurgico a traves de ella.
En una realizaci6n, el introductor de instrumento incluye ademas una pestana extendida radialmente hacia fuera desde un borde terminal proximal de la porci6n extrema proximal de le envoltura cilindrica.
En una realizaci6n, la caperuza esta fijada al extremo distal de la envoltura cilindrica tal que la pared extrema distal de la caperuza esta separada en una distancia del borde terminal distal de la envoltura cilindrica. En otra realizaci6n, la caperuza esta fijada al extremo distal de la envoltura cilindrica tal que un borde terminal proximal de la pared lateral anular esta fijado al borde terminal distal de la envoltura cilindrica.
La pared extrema distal de la caperuza esta formada para definir un bolsillo extendido en direcci6n distal y en la que la abertura esta formada en el bolsillo. El bolsillo tiene un diametro menor que el diametro de la pared lateral anular.
La presente invenci6n es usada en metodos para introducir un instrumento quirurgico dentro de una cavidad o una abertura corporal de un paciente. Un metodo tal incluye el paso de proporcionar un introductor de instrumento, en el que el introductor de instrumento incluye una envoltura tubular hueca que tiene una porci6n extrema distal y una porci6n extrema proximal que definen un lumen entre ellas, y una caperuza elastica fijada al extremo distal de la envoltura tubular, teniendo la caperuza una abertura formada en ella. El metodo incluye ademas los pasos de4 insertar el extremo distal del introductor de instrumento dentro de la cavidad o abertura corporal del paciente, insertar un instrumento quirurgico dentro del lumen de la envoltura tubular del introductor de instrumento a traves del extremo proximal de la envoltura tubular y avanzar el instrumento quirurgico a traves del lumen de la envoltura tubular del introductor de instrumento hasta que el extremo distal del instrumento quirurgico sobresale a traves de la abertura de la caperuza, en el que la caperuza crea una selladura alrededor del perimetro del instrumento quirurgico extendido desde ella.
En otro metodo tal, el extremo distal de un instrumento quirurgico es insertado primero dentro del extremo proximal de la envoltura tubular del introductor de instrumento, el extremo distal del instrumento quirurgico, teniendo el introductor de instrumento situado sobre el, es insertado despues dentro de la cavidad o abertura corporal del paciente, entonces el instrumento quirurgico es avanzado a traves del introductor de instrumento hasta que el extremo distal del instrumento quirurgico sobresale a traves de la abertura de la caperuza.
La presente exposici6n habilita un introductor de instrumento quirurgico que facilita la inserci6n del extremo distal del instrumento quirurgico dentro de una cavidad o una abertura corporal de un paciente.
La presente exposici6n proporciona un introductor de instrumento que reduce el potencial de irritaci6n y/o trauma como un resultado de la inserci6n del instrumento quirurgico dentro de la cavidad o abertura corporal del paciente si el instrumento quirurgico fuera a ser insertado dentro de la cavidad o abertura corporal del paciente sin el introductor de instrumento acoplado operativamente a el.
El introductor de instrumento expuesto actualmente, junto con ventajas relacionadas, sera ilustrado mas claramente a continuaci6n por la descripci6n de los dibujos y la descripci6n detallada de las realizaciones preferidas.
Otros objetos y caracteristicas de la presente exposici6n resultaran evidentes a partir de la consideraci6n de la descripci6n siguiente tomada en conjunci6n con los dibujos adjuntos.
Descripci6n breve de los dibujos
A modo de ejemplo solamente, una realizaci6n preferida de la invenci6n sera descrita con referencia a los dibujos adjuntos de las Figuras 3, 3A, 4 y 4A.
La Figura 1 es una vista en perspectiva desde arriba de un introductor de instrumento que no es una realizaci6n de la presente invenci6n, teniendo una pestana adyacente al extremo proximal;
la Figura 1A es una vista en perspectiva desde arriba en despiece ordenado del introductor de instrumento representado en la Figura 1;
la Figura 1B es una vista lateral en corte transversal, tomada a lo largo del eje longitudinal, del extremo distal del introductor de instrumento representado en la Figura 1;
la Figura 1C es una vista en perspectiva desde abajo del introductor de instrumento representado en la Figura 1, con la pestana suprimida;
la Figura 2A es una vista desde el extremo de una pared extrema distal alternativa de la porci6n extrema distal de un introductor de instrumento que no es una realizaci6n de la presente invenci6n,
la Figura 2B es una vista en alzado lateral en corte trasversal de la porci6n extrema distal de un introductor de instrumento, representando otra pared extrema distal alternativa de un introductor de instrumento que no es una realizaci6n de la presente invenci6n;
la Figura 3 es una vista en perspectiva, con porciones separadas, de una realizaci6n de la presente invenci6n de una porci6n extrema distal del introductor de instrumento, con una porci6n extrema distal de instrumento quirurgico de diametro relativamente menor insertada dentro del extremo distal de el;
la Figura 3A es una vista en alzado lateral en corte transversal, tomada a lo largo del eje longitudinal, del introductor de instrumento representado en la Figura 3, representando el extremo distal del instrumento quirurgico de diametro relativamente menor insertado en el:
la Figura 4 es una vista en perspectiva, con porciones separadas, del introductor de instrumento representado en la Figura 1, con la porci6n extrema distal de un instrumento quirurgico de diametro relativamente mayor insertada dentro del extremo distal de el;
la Figura 4A es una vista en alzado lateral en corte transversal, tomada a lo largo del eje longitudinal, del introductor representado en la Figura 4, representando el extremo distal del instrumento quirurgico de diametro relativamente mayor insertado en el;
la Figura 5 es una vista en perspectiva de un introductor de instrumento que no es una realizaci6n de la presente invenci6n, como se representa en la Figura 1, ilustrando el peso de un conjunto de yunque de un instrumento quirurgico a traves de un pasaje formado en la superficie extrema distal de el;
la Figura 6 es una vista lateral en corte transversal, tomada a lo largo del eje longitudinal, de un introductor de instrumento que no es una realizaci6n de la presente invenci6n; y
la Figura 7 es una vista lateral en corte transversal, tomada a lo largo del eje longitudinal, de un introductor de instrumento que no es una realizaci6n de la presente invenci6n.
Descripci6n detallada de realizaciones preferidas
El dispositivo segun la presente invenci6n es especialmente adecuado para introducir una porci6n extrema distal de un instrumento quirurgico dentro de cavidades corporales tales como, por ejemplo, orificios anales, la abertura uretral externa o la boca de un paciente, para realizar, por ejemplo, aplicaciones hemorroidales o anastom6ticas de extremo a extremo, tambien puede ser usado en conexi6n con otros procedimientos quirurgicos para realizar cualquier numero de otros instrumentos quirurgicos endosc6picos o laparosc6picos en los que instrumentos quirurgicos de extremos romos son introducidos dentro de los cuerpos de pacientes.
En los dibujos y en la descripci6n que sigue, el termino "proximal", como es tradicional, se referira al extremo de la entidad que esta mas cerca del operador mientras que el termino "distal" se referira al extremo del dispositivo que esta mas lejos del operador.
Refiriendose ahora con detalle especifico a los dibujos, en los que los numero de referencia iguales identifican elementos similares o identicos, las Figuras 1, 1A, 1B y 1C ilustran un introductor 10 de instrumento quirurgico designado generalmente con el numero 10 de referencia. El introductor de instrumento quirurgico esta en la forma de una vaina, revestimiento, mango, manguito, cobertura, envoltura, preservativo, etc. Por consiguiente, como se usa en esto, el introductor 10 de instrumento puede materializar uno cualquiera de estos terminos.
Como sera descrito adicionalmente despues, el introductor 10 de instrumento esta configurado y adaptado para ser montado separablemente en la porci6n extrema distal de un instrumento quirurgico (por ejemplo, grapadora anastom6tica) antes de la inserci6n del instrumento quirurgico dentro de un orificio del cuerpo o para colocaci6n inicial dentro del orificio del cuerpo y para colocaci6n inicial dentro del orificio del cuerpo y para inserci6n
subsiguiente en el de la porci6n extrema distal del instrumento quirurgico. Preferiblemente, el introductor 10 de instrumento tiene una forma que facilita su entrada dentro del orificio del cuerpo y que tambien es compatible con la porci6n extrema distal del instrumento quirurgico. Se considera que el introductor 10 de instrumento funciona como una vaina o manguito protector para tapar el extremo distal de, y facilitar la entrada de la porci6n extrema distal de, el instrumento quirurgico dentro del orificio del cuerpo. Ademas, el introductor 10 de instrumento puede actuar como una barrera aisladora y/o una barrera aislante entre el instrumento quirurgico y el cuerpo del paciente.
Preferiblemente, el introductor 10 tiene dos secciones principales, a saber, una secci6n tubular hueca 12 y una porci6n extrema distal 14 unida adyacente al borde distal 12a (vease la Figura 1A) de la secci6n tubular 12. Se considera que el introductor 10 de instrumento puede ser construido a partir de una secci6n tubular 12 y una porci6n extrema distal 14 fabricadas de materiales diferentes que, a su vez, son unidas entre si, o el introductor 10 puede ser formado monoliticamente en cuyo caso la secci6n tubular 12 y la porci6n extrema distal 14 son fabricadas de un solo material seleccionado especificamente dependiendo de su aplicaci6n deseada.
La secci6n tubular hueca 12 incluye una pared anular 16 que define un lumen 18 a traves de ella, cuyo lumen 18 define un eje longitudinal central "A". Preferiblemente, la pared auxiliar 16 tiene un diametro interior dimensionado para recibir la porci6n extrema distal del instrumento quirurgico. Se preve que la secci6n tubular 12 puede variar en longitud dependiendo del instrumento quirurgico que va a ser insertado dentro del orificio del cuerpo a traves del lumen 18 y dependiendo de la aplicaci6n quirurgica particular en la que el introductor 10 de instrumento va a ser usado. Preferiblemente, la secci6n tubular 12 variara en longitud desde unos cinco centimetros a unos veinte centimetros.
La secci6n tubular 12 es fabricada preferiblemente de un material de plastico moldeable adecuado con maleabilidad suficiente para proporcionar desviaci6n controlada y rigidez suficiente para retener la forma durante la inserci6n y el uso. La secci6n tubular 12 es fabricada preferiblemente de polipropileno o material de calidad medica aceptable similar capaz de esterilizaci6n.
Preferiblemente, la porci6n extrema distal 14 esta en la forma de una caperuza que tiene una pared extrema distal 20 preferiblemente circular y una pared lateral anular 22 dependiente de modo sustancialmente ortogonal de un borde terminal exterior 24 de la pared extrema 20. La pared extrema 20 limita un agujero pasante circular 26 formado en ella, en donde el eje central del agujero pasante 26 es sustancialmente coaxial con el eje longitudinal central "A" del lumen 18. Aunque el eje central del agujero pasante 26 ha sido descrito como siendo coaxial con el eje longitudinal "A", se preve que el agujero pasante 26 no necesita ser concentrico con el lumen 18 o que la pared extrema 20 puede definir agujeros adicionales que tienen alineaciones y orientaciones direccionales variables para el paso de porciones de un instrumento quirurgico a traves de ellos.
La porci6n extrema distal 14 del introductor 10 de instrumento, y preferiblemente al menos la pared extrema distal 20 de la porci6n extrema distal 14, es fabricada de un material flexible/maleable/estirable, preferiblemente un material termoformable, mas preferiblemente un material extrudible o moldeable por inyecci6n, y mas preferiblemente un elast6mero o material elastomerico. La porci6n extrema distal 14 esta configurada y adaptada para recibir en ella el extremo distal del instrumento quirurgico, y para deformarse y ceder alrededor del extremo distal del instrumento quirurgico durante el avance del extremo distal del instrumento quirurgico a traves del lumen 18 de la secci6n tubular 12 y contra la superficie interior de la pared extrema distal 20 de la porci6n extrema distal 14.
Las reivindicaciones definen un introductor con una abertura circular abierta. En una alternativa, se considera que el agujero pasante 26 puede ser cerrado parcial o completamente, o la pared extrema distal 20 puede ser debilitada por lineas 26A de estrias (vease la Figura 2A), adelgazada (vease la Figura 2B), provista de perforaciones o porciones reticuladas (no mostradas) que definen los limites del agujero pasante 26. En una alternativa mas, el agujero pasante 26 puede ser una rendija formada en la pared extrema 20 de la porci6n extrema distal 14. En esta alternativa, el agujero pasante 26 de la porci6n extrema distal 14 es abierta o creada despues por el operador del instrumento quirurgico y/o el introductor 10 de instrumento o por la aplicaci6n de una fuerza axial a la superficie interior de la pared extrema distal 20 por avance del extremo distal del instrumento quirurgico a traves del lumen 18 del introductor 10 de instrumento y contra la pared extrema distal 20 debilitada.
Volviendo a las Figuras 1 a 1C y en particular a la Figura 1B, preferiblemente, la pared lateral anular 22 de la porci6n extrema distal 14 tiene un diametro interior que es sustancialmente igual que el diametro exterior de la secci6n tubular 12. Como tal, la porci6n extrema distal 14 es ajustada exactamente sobre la porci6n extrema distal de la secci6n tubular 12. Por consiguiente, se restringe o impide que la porci6n extrema distal 14 deslice fuera del borde distal 12a de la secci6n tubular 12, reduciendo de tal modo la propensi6n de la porci6n extrema distal 14 a separarse de la secci6n tubular 12.
Como se ve en la Figura 1B, la porci6n extrema distal 14 es fijada preferiblemente en "B" alrededor del extremo distal de la secci6n tubular 12. Se considera que la porci6n extrema distal 14 es fijada alrededor del extremo distal de la secci6n tubular 12 por fusi6n, un tto shot, sobremoldeo, encolado u otros procesos de adherencia conocidos por los expertos en la tecnica. Ademas, toda la longitud de la pared lateral anular 22 de la porci6n extrema distal 14 esta en contacto preferiblemente.
Como se ve en las Figuras 1 y 1A, la secci6n tubular 12 incluye una estructura que tiene una o mas porciones extendidas hacia fuera radialmente tales como orejetas o mas preferiblemente tal como una pestana continua 28 (representada como lineas de trazos en las Figuras 1 y 1A) integral con o conectada al borde proximal 29 de la secci6n tubular 12. En un aspecto de la exposici6n, la pestana 28 funciona para limitar la profundidad de entrada del introductor 10 de instrumento dentro del cuerpo del paciente. La pestana 28 puede proporcionar ventajosamente una superficie adecuada para la colocaci6n de adhesivos o cintas, por ejemplo tales como los vendidos con la marca de fabrica Steri-strip, para fijar o sujetar el introductor 10 de instrumento y potencialmente el instrumento quirurgico con respecto al paciente y limitar la profundidad de penetraci6n del introductor 10 de instrumento y/o del extremo distal del instrumento quirurgico dentro del cuerpo del paciente. Aunque se preve que la pestana 28 ha de ser usada cuando el introductor 10 de instrumento es empleado como un dispositivo aut6nomo que no esta conectado a un instrumento quirurgico, se preve que un introductor 10 de instrumento que tiene una pestana 28 tambien puede ser empleado cuando el introductor 10 de instrumento es conectado al instrumento quirurgico antes de la inserci6n del introductor 10 del instrumento dentro de la cavidad o abertura corporal del paciente.
Aunque la porci6n extrema distal 14 del introductor 10 de instrumento es preferiblemente de un material flexible/maleable/estirable adaptado para acomodar la porci6n extrema distal de un instrumento quirurgico, se preven realizaciones alternativas donde la porci6n extrema distal 14 utiliza pliegues predispuestos o formados o combinaciones de pliegues que flexionan y/o se estiran y tienen una forma adecuada para penetraci6n y paso de la punta, cabeza, conjunto, subconjunto o efector extremo del instrumento del instrumento quirurgico. En una realizaci6n alternativa adicional, la porci6n extrema distal 14 puede ser fabricada a partir de una malla radialmente expansible tal que la porci6n extrema distal 14 es expansible para acomodar la porci6n extrema distal del instrumento quirurgico.
Aunque dos materiales diferentes han sido descritos en esto con referencia a la secci6n tubular 12 y la porci6n extrema distal 14 respectivas, se preve que un solo elast6mero o combinaciones de elast6meros y materiales flexibles/estirables de medidas de dureza diferentes, teniendo caracteristicas adecuadas, pueden ser usadas para fabricar el introductor 10 de instrumento. Por ejemplo, la pared extrema distal puede tener una medida de dureza que la hace mas flexible que la pared lateral anular 22, permitiendo de tal modo que la porci6n extrema distal de un instrumento quirurgico pase mas facilmente a traves del agujero pasante 26 de la porci6n extrema distal 14.
Volviendo ahora a las Figuras 3 y 3A, se ilustra una realizaci6n de un introductor 10 de instrumento de la presente invenci6n. Como se muestra en las Figuras 3 y 3A, el introductor 10 de instrumento incluye una porci6n extrema distal 14 en la que la pared extrema distal de ella define un bolsillo 30. El bolsillo 30 se extiende en direcci6n distal desde la pared extrema distal 20 y es definido por tener un diametro que es menor que el diametro de la pared lateral anular 22. Ademas el bolsillo 30 esta provisto del agujero pasante 26 formado centralmente en el. Preferiblemente, el diametro del bolsillo 30 corresponde sustancialmente al diametro del extremo distal de un instrumento quirurgico "S" que tiene un diametro relativamente menor que el diametro interior de la pared anular 16 de la secci6n tubular 12. Por consiguiente, cuando el instrumento quirurgico "S" de diametro relativamente menor es recibido dentro del introductor 10 de instrumento, el extremo distal del instrumento quirurgico "S" de diametro menor es recibido ajustado exactamente dentro del bolsillo 30. Cuando el instrumento quirurgico "S" de diametro menor es avanzado en direcci6n distal a traves del introductor 10 de instrumento, el bolsillo 30 se estira/flexiona en direcci6n distal y el agujero pasante 26 se estira/flexiona radialmente hacia fuera hasta un diametro suficiente para acomodar el paso a traves de el del instrumento quirurgico "S" de diametro menor.
Volviendo ahora a las Figuras 4 y 4A, un instrumento quirurgico "L" de diametro relativamente mayor, que tiene un diametro exterior ligeramente menor que el diametro interior de la pared anular 16 de la secci6n tubular 12, es mostrado insertado dentro del introductor 10 de instrumento. Cuando el instrumento quirurgico "L" de diametro mayor es avanzado en direcci6n distal a traves del introductor 10 de instrumento, el bolsillo 30 se estira/flexiona para adaptarse a la forma del extremo distal del instrumento quirurgico "L" de diametro mayor. Cuando el instrumento quirurgico "L" de diametro mayor es avanzado mas a traves del introductor 10 de instrumento, el agujero pasante 26 se estira/flexiona radialmente hacia fuera hasta un diametro suficiente para acomodar el paso a traves de el del instrumento quirurgico "L" de diametro mayor.
Como se ve en la Figura 5, la porci6n extrema distal 14, incluyendo el agujero pasante 26, puede tener elasticidad suficiente para acomodar el paso una cabeza "H" del instrumento quirurgico "S" o "L" de diametro menor o mayor a traves del agujero pasante 26, y es predispuesto adecuadamente en cada caso para volver al primer estado no estirado despues del paso de la cabeza "H" a traves de el. El introductor 10 de instrumento esta configurado para estirarse/flexionar para acomodar el paso a traves de el de la cabeza "H" del instrumento quirurgico "S" o "L" de diametro menor o mayor cuando la cabeza "H" pasa en direcci6n proximal y distal a traves del agujero pasante 26.
Volviendo ahora a las Figuras 6 y 7, se exponen introductores 10 de instrumentos alternativos. Como se ve en las Figuras 6 y 7, se preve que la pared extrema distal 20 de la porci6n extrema distal 14 esta separada en una distancia "Y" del borde distal 12a de la secci6n tubular 12. En la realizaci6n mostrada en la Figura 6, la superficie interna de la pared lateral anular 22 de la porci6n extrema distal 14 esta en contacto con la superficie exterior del extremo distal de la pared anular 16 de la secci6n tubular 12 tal que la pared extrema distal 20 esta separada en una distancia "Y" del borde distal 12a de la secci6n tubular 12. Ademas, la pared lateral anular 22 de la porci6n extrema
distal 14 se solapa con el extremo distal de la pared anular 16 de la secci6n tubular 12 en una magnitud "Y1". Como se describi6 antes, preferiblemente, la superficie interior de la pared anular 22 de la porci6n extrema distal 14 es fusionada, adherida, etc., en "B", a la superficie exterior de la pared anular 16 de la secci6n tubular 12.
En la Figura 7, se preve que el borde proximal 33 de la pared lateral anular 22 de la porci6n extrema distal 14 sea fusionado, adherido, etc., en "B", al borde distal 12a de la secci6n tubular 12. De esta manera, toda la longitud de la pared anular 22 de la porci6n extrema distal 14 se extiende desde la secci6n tubular 12.
El funcionamiento del introductor 10 de instrumento sera descrito ahora con referencia a las Figuras 1 a 5. En un metodo preferido de uso, el introductor 10 de instrumento es situado inicialmente sobre la porci6n extrema distal de un instrumento quirurgico. Cuando la porci6n extrema distal del instrumento quirurgico, con el introductor 10 de instrumento situado sobre ella, es insertada y/o introducida dentro de una cavidad o abertura corporal de un paciente (por ejemplo, el ano), la pared extrema distal flexible/estirable 20 de la porci6n extrema distal 14 del introductor 10 de instrumento es flexionada/estirada en la direcci6n axial como resultado de que las paredes laterales de la cavidad
o abertura corporal del paciente crean una resistencia al avance del introductor 10 de instrumento y del avance distal continuado del instrumento quirurgico a traves del lumen 18 del introductor 10 de instrumento. Cuando el instrumento quirurgico es avanzado mas en direcci6n distal, la porci6n extrema distal del instrumento quirurgico deforma y/o estira al menos parcialmente la porci6n extrema distal 14 del introductor 10 de instrumento y deforma y/o estira el agujero pasante 26, aumentandolo radialmente, hasta un diametro suficiente para acomodar el paso de la cabeza "H" del instrumento quirurgico a traves del introductor 10 de instrumento y, si es necesario, acomodar el paso de la porci6n extrema distal del instrumento quirurgico (no mostrado).
En un metodo alternativo de uso, el introductor 10 de instrumento es colocado inicialmente dentro de la cavidad o abertura corporal del paciente tal que la porci6n extrema distal 14 del introductor 10 de instrumento es retenida dentro de ella. Con el introductor 10 de instrumento en su lugar, el extremo distal de un instrumento quirurgico es insertado dentro del lumen 18 del introductor 10 de instrumento y es avanzado hasta que el extremo distal del instrumento quirurgico hace contacto con la superficie interior de la pared extrema distal 20 de la porci6n extrema distal 14 del introductor 10 de instrumento. De modo similar al metodo descrito anteriormente, cuando el instrumento quirurgico es avanzado mas en direcci6n distal dentro del introductor 10 de instrumento, la porci6n extrema distal del instrumento quirurgico empieza a deformar y/o estirar parcialmente la porci6n extrema distal 14 del introductor 10 de instrumento y a deformar y/o estirar el agujero 26 y aumentarlo radialmente hasta un diametro suficiente para acomodar el paso de la cabeza "H" del instrumento quirurgico a traves del introductor 10 de instrumento y, si es necesario, acomodar el paso de la porci6n extrema distal del instrumento quirurgico (no mostrado).
En cualquier metodo, los expertos en la tecnica comprenden que la pestana 28 limitara la profundidad de penetraci6n del introductor 10 de instrumento dentro de la cavidad o la abertura corporal del paciente. Adicionalmente, en cualquier metodo, se considera que un lubricante es aplicado a la superficie exterior del introductor 10 de instrumento para facilitar la inserci6n del introductor 10 de instrumento dentro de la cavidad o abertura corporal del paciente, y opcionalmente a la superficie interior del introductor 10 de instrumento y/o a la superficie exterior del instrumento quirurgico para facilitar la inserci6n del instrumento quirurgico dentro del introductor 10 de instrumento.

Claims (10)

  1. REIVINDICACIONES
    1. Un introductor (10) de instrumento para facilitar la inserci6n de un instrumento quirurgico (S) dentro de una cavidad o una abertura corporal de un paciente protegiendo el tejido que rodea a la abertura corporal contra el trauma causado por las superficies extremas distales del instrumento, comprendiendo el introductor:
    una porci6n de envoltura tubular (12) que define un lumen (18) a traves de ella, teniendo la porci6n de envoltura tubular un extremo proximal abierto para recibir el instrumento fuera de la abertura corporal, y un extremo distal; y
    una porci6n extrema distal (14) fijada al extremo distal (12a) de la porci6n de envoltura tubular, incluyendo la porci6n extrema distal una pared extrema distal (20), incluyendo ademas la porci6n extrema distal una pared lateral anular
    (22) pendiente del borde terminal exterior de la pared extrema distal, caracterizado porque
    la pared extrema distal de la porci6n extrema distal limita una abertura circular abierta (26) formada en ella e incluye una superficie interior para hacer contacto con el extremo distal del instrumento quirurgico, en el que la porci6n extrema distal esta configurada y adaptada para facilitar el paso de un instrumento quirurgico a traves de la abertura; y
    en el que la pared extrema distal de la porci6n extrema distal (14) esta formada para definir un bolsillo (30) extendido en direcci6n distal que tiene un diametro menor que el diametro de la pared lateral anular, en el que la abertura esta formada en el bolsillo.
  2. 2.
    El introductor de instrumento segun la reivindicaci6n 1, en el que la porci6n extrema distal es fabricada de un material elastomerico.
  3. 3.
    El introductor de instrumento segun cualquiera de las reivindicaciones precedentes, en el que la abertura esta alineada coaxialmente con un eje longitudinal central (A) de la porci6n de envoltura tubular.
  4. 4.
    El introductor de instrumento segun cualquiera de las reivindicaciones precedentes, en el que la porci6n extrema distal esta fijada al extremo distal de la porci6n de envoltura tubular tal que la pared lateral anular solapa al menos parcialmente el extremo distal de la porci6n de envoltura tubular.
  5. 5.
    El introductor de instrumento segun la reivindicaci6n 4, en el que la porci6n extrema distal esta fijada al extremo distal de la porci6n de envoltura tubular tal que la pared lateral anular solapa completamente el extremo distal de la porci6n de envoltura tubular.
  6. 6.
    El introductor de instrumento segun la reivindicaci6n 5, en el que la porci6n extrema distal esta fijada al extremo distal de la envoltura tubular por al menos uno de fusi6n, sobremoldeo, encolado y ligaz6n.
  7. 7.
    El introductor de instrumento segun la reivindicaci6n 6, en el que la porci6n de envoltura tubular es fabricada de polipropileno.
  8. 8.
    Un introductor de instrumento segun cualquiera de las reivindicaciones precedentes, en el que:
    la porci6n de envoltura tubular es hueca y la porci6n extrema distal es una caperuza elastica fijada al extremo distal de la porci6n de envoltura tubular, y comprendiendo ademas el instrumento quirurgico;
    en el que cuando el introductor es usado, el extremo distal del instrumento quirurgico sobresale a traves de la abertura de la caperuza, y la caperuza crea una selladura alrededor del perimetro del instrumento quirurgico extendido desde ella.
  9. 9.
    El introductor de instrumento de una cualquiera de las reivindicaciones precedentes tal que el extremo distal del instrumento quirurgico hace contacto con la superficie de la pared extrema distal de la porci6n extrema distal durante el avance del instrumento quirurgico en la abertura o cavidad corporal y, cuando el introductor de instrumento encuentra resistencia al avance del introductor de instrumento, el extremo distal del instrumento quirurgico estira la porci6n extrema distal del introductor, aumentando radialmente la abertura de la pared extrema distal para acomodar el paso del extremo distal del instrumento quirurgico a traves de la abertura.
  10. 10.
    El introductor de instrumento segun una cualquiera de las reivindicaciones precedentes, en el que el instrumento quirurgico es una grapadora quirurgica anastom6tica intraluminal.
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Also Published As

Publication number Publication date
EP1494601A1 (en) 2005-01-12
US7846149B2 (en) 2010-12-07
US20050143756A1 (en) 2005-06-30
WO2003088854A1 (en) 2003-10-30
EP1494601B1 (en) 2012-01-11
AU2003234718A1 (en) 2003-11-03

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