ES2273363T3 - Doble stent extensible. - Google Patents

Doble stent extensible. Download PDF

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Publication number
ES2273363T3
ES2273363T3 ES97911649T ES97911649T ES2273363T3 ES 2273363 T3 ES2273363 T3 ES 2273363T3 ES 97911649 T ES97911649 T ES 97911649T ES 97911649 T ES97911649 T ES 97911649T ES 2273363 T3 ES2273363 T3 ES 2273363T3
Authority
ES
Spain
Prior art keywords
stent
flared
main
vessel
stents
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
ES97911649T
Other languages
English (en)
Inventor
Gil M. Vardi
Charles J. Davidson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Advanced Stent Technologies Inc
Original Assignee
Advanced Stent Technologies Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Advanced Stent Technologies Inc filed Critical Advanced Stent Technologies Inc
Application granted granted Critical
Publication of ES2273363T3 publication Critical patent/ES2273363T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/856—Single tubular stent with a side portal passage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91583—Adjacent bands being connected to each other by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

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Abstract

SE EXPONE UN APARATO DE STENT (10), EXTENSIBLE Y DEL QUE PUEDE OBTENERSE LA IMAGEN, PARA INSERCION EN UN VASO BIFURCADO QUE TIENE UN VASO PRINCIPAL (8) Y VASOS RAMIFICADOS (7). EL STENT (10) COMPRENDE UN STENT PRINCIPAL (12) Y UN STENT ABOCINADO (15), QUE PUEDEN UTILIZARSE INDIVIDUALMENTE O COMBINADOS ENTRE SI. EL STENT ABOCINADO (15) PUEDE ENCLAVARSE CON EL STENT PRINCIPAL (12) PARA CUBRIR TODA LA ZONA DE LA BIFURCACION. EL STENT ABOCINADO (15) TIENE UN EXTREMO PROXIMAL (30) CON LA PARTE ABOCINADA REALIZADA CON BUCLES EXTENDIDOS (18) QUE SE ADAPTAN AL LADO DEL STENT PRINCIPAL (12).

Description

Doble stent extensible.
Antecedentes
Un tipo de dispositivo de endoprótesis, conocido habitualmente como stent, se sitúa o se implanta dentro de una vena, arteria u otro órgano corporal tubular, para el tratamiento de oclusiones, estenosis, o aneurismas del vaso. Estos dispositivos stent se implantan en el interior de vasos tubulares para reforzar segmentos de la pared del vaso colapsados, parcialmente ocluidos, debilitados, o dilatados anormalmente. Los stents han sido utilizados para tratar disecciones en las paredes de vasos sanguíneos provocadas por angioplastia de globo de las arterias coronarias, así como también de las arterias periféricas, y para mejorar los resultados de la angioplastia al evitar la retrocesión y la remodelación elásticas de la pared del
vaso.
Los stents han sido implantados con éxito en el tracto urinario, el conducto biliar, el esófago y el árbol traqueo-bronquial, para reforzar estos órganos corporales. Dos pruebas multicentro aleatorizadas han mostrado recientemente una velocidad de restenosis más baja en las arterias coronarias tratadas con stents en comparación con la angioplastia de globo sola (Serruys PW et al., Revista de Medicina New England 331; 489-495; 1994, Fischman DL et al., Revista de Medicina New England 331; 496-501, 1994).
Uno de los inconvenientes de los stents convencionales consiste en que se fabrican con una configuración tubular recta. El uso de tales stents para tratar la enfermedad en, o cerca de, una ramificación o una bifurcación de un vaso, corre el riesgo de comprometer el grado de abertura del vaso primario y/o de sus ramas o bifurcación, y también limita la capacidad de inserción de un segundo stent en la ramificación lateral si el resultado de la angioplastia está por debajo del óptimo. Esto puede ocurrir como resultado de diversos mecanismos tales como desplazamiento de tejido enfermo o cambio de placa, espasmo de vaso, disección con o sin labios intimales, trombosis y embolismo.
El riesgo de compromiso de ramificación se incrementa en dos situaciones anatómicas. En primer lugar, la ramificación lateral puede verse comprometida cuando existe una estenosis en el origen de la ramificación lateral. En segundo lugar, cuando existe una lesión excéntrica en el lugar de la bifurcación, la expansión asimétrica puede causar el cambio de placa o bien la disección en el origen de la ramificación lateral. Existen informes de intentos de resolver este problema insertando un globo en la ramificación lateral a través de la columna del stent; sin embargo, esta técnica comporta el riesgo de oclusión de globo y otras complicaciones importantes (Nakamura, S. et al., Cateterización y Diagnosis Cardiovascular 34: 353-361 (1995)). Además, la dilatación adecuada de la ramificación lateral está limitada por la retrocesión elástica del origen de la ramificación lateral. Adicionalmente, el stent puede plantear una limitación al flujo sanguíneo y puede limitar el acceso a la ramificación lateral. Con frecuencia se utiliza el término "prisión de stent" para describir este concepto. A este respecto, el diseño abisagrado ranurado tubular de stent intracoronario de Palmaz-Schatz, en particular, se estima que es desfavorable para lesiones con una gran ramificación lateral, y se cree que plantea un mayor riesgo de oclusión de vaso de ramificación lateral donde el stent impide o limita el acceso a la ramificación lateral. Id.
Un procedimiento común para implantar la endoprótesis o stent, consiste en abrir en primer lugar la región del vaso con un catéter de globo, y a continuación colocar el stent en una posición que puentea la porción tratada del vaso, con el fin de evitar la retrocesión elástica y la restenosis de ese segmento. La angioplastia de la lesión de bifurcación ha sido realizada tradicionalmente utilizando la técnica del globo besador, en la que se insertan dos alambres-guía y dos globos, uno hacia la ramificación principal y el otro hacia la ramificación lateral. La colocación del stent en esta situación requerirá la retirada del alambre-guía desde la ramificación lateral, y la reinserción del alambre-guía a través de las columnas de, y la inserción de un globo a través de las columnas de stent. La retirada del alambre-guía plantea el riesgo de oclusión de la ramificación lateral durante el despliegue del stent en la ramificación principal.
Las patentes de la técnica anterior se refieren a la construcción y diseño tanto del stent como del aparato para el posicionamiento del stent en el interior del vaso. Una patente típica, de Chaudhury, la Patente U.S. núm. 4.140.126, describe una técnica para posicionar un stent cilíndrico alargado en una región de un aneurisma, para evitar el fallo catastrófico de la pared del vaso sanguíneo. La Patente 4.140.126 describe un cilindro que se expande hasta su configuración de implantado tras la inserción con la ayuda de un catéter. La Patente U.S. núm. 4.503.569, de Dotter, describe un stent de resorte, que se expande hasta una configuración de implantado con un cambio de temperatura. El stent de resorte se implanta con una orientación arrollada, y a continuación se calienta para provocar que el resorte se expansione. Palmas, en la Patente U.S. núm. 4.733.665, describe un número de configuraciones de stent para su implantación con la ayuda de un catéter. El catéter incluye un mecanismo para montar y retener la prótesis vascular o stent, preferiblemente sobre una porción inflable del catéter. Los stents son implantados mientras son visualizados en un monitor. Una vez que el stent se ha posicionado apropiadamente, el catéter se expande y el stent se separa del cuerpo de catéter. El catéter puede ser entonces retirado del sujeto, dejando el stent en su lugar en el interior del vaso sanguíneo. Palmaz, en la Patente U.S. núm. 4.739.762, describe un injerto intraluminal expansionable. Schjeldahl et al., en la Patente U.S. núm. 4.413.989, describe una diversidad de construcciones de catéter de globo. Maginot, en la Patente U.S. núm. 5.456.712 y Maginot, en la Patente U.S. núm. 5.304.220, describen un conjunto de injerto y stent y un procedimiento de implantación en el que se utiliza un stent para reforzar un injerto insertado quirúrgicamente en un vaso sanguíneo con el fin de desviarse de una oclusión. Sin embargo, ninguna de estas patentes se refiere al tratamiento de lesiones de bifurcación, ni describen ningún aparato de stent de bifurcación ni el procedimiento para desplegar el mismo.
Taheri, en la Patente U.S. núm. 4.872.874, Piplani et al., en la Patente U.S. núm. 5.489. 295, y Marin et al., en la Patente U.S. núm. 5.507.769, describen material de injerto de bifurcación que puede ser implantado con los stents. Sin embargo, no existe ninguna mención de bifurcación del stent, y el stent se utiliza solamente para anclar el injerto en la pared del vaso. Éste no refuerza la pared del vaso, y no evita la restenosis tras la angioplastia.
MacGregor, en la Patente U.S. núm. 4.994.071, describe un stent bifurcador abisagrado. En la Patente 4.994.071, al contrario que en la presente invención, existe un stent principal con dos stents adicionales sujetos a un extremo, dando lugar a una única unidad con una bifurcación. Los dos dilatadores adicionales están sujetos permanentemente y no pueden ser separados del stent principal. De este modo, esta invención no puede ser utilizada en vasos sin bifurcación. Adicionalmente, estudios con stents que contienen abisagramientos, han mostrado que existe una alta incidencia de restenosis (crecimiento de tejido) en el punto de abisagramiento que puede causar un estrechamiento, o la oclusión total, del vaso, y comprometer con ello el flujo sanguíneo. También, al tener los dos stents adicionales conectados al stent principal, el rastreo por una ramificación lateral con amplio ángulo puede resultar difícil y puede conllevar el riesgo de disección de la pared del vaso. Además, una vez que el dispositivo de la Patente 4.994.071 ha sido implantado, es posible intercambiar el stent de la ramificación lateral en caso que sea necesario para alcanzar un tamaño diferente de stent.
El estado de la técnica conforme al documento WO-A-96 29955 (Figuras 14 a 16), se refiere a un stent que tiene una abertura en la pared lateral, en cuya abertura puede alojarse un segmento de stent.
En general, cuando se trata una lesión de bifurcación utilizando stents disponibles comercialmente, debe ponerse un gran cuidado para cubrir el inicio de la ramificación, puesto que si deja al descubierto, esta zona es proclive a la restenosis. Con el fin de cubrir el inicio de la ramificación, los dilatadores convencionales deben, o bien sobresalir hacia el lumen de la arteria o vaso principal desde la ramificación (lo que puede provocar trombosis [coagulación de la sangre], comprometiendo de nuevo el flujo sanguíneo), o bien deben ser situados completamente en el interior de la ramificación, y no podrán por lo general cubrir el inicio de la bifurcación. Otra complicación frecuente experimentada con los stents para bifurcaciones, incluye el estrechamiento u oclusión del inicio de una ramificación lateral por la que se extiende un stent situado en la ramificación principal. Por último, la colocación de un stent en un vaso principal en el que se extiende total o parcialmente un stent, o en el que se extiende completamente a través de la abertura de una ramificación, puede hacer que el acceso futuro a tales vasos de la ramificación resulte difícil, si no imposible.
Además, la tecnología de los stents convencionales, es inadecuada como medio de tratamiento de lesiones ostiales. Las lesiones ostiales son lesiones en el origen de un vaso. Por ejemplo, las lesiones ostiales pueden formarse en las arterias renales, las cuales son ramificaciones laterales que se extienden desde la aorta. Las lesiones ostiales son proclives a la restenosis debido a la retrocesión elástica del vaso principal, tal como la aorta. Por lo tanto, la cubierta del stent debe incluir el espesor de la pared del vaso principal. Esto es extremadamente difícil de realizar sin que el stent sobresalga hacia el vaso principal.
Finalmente, los stents convencionales son difíciles de visualizar durante y después del despliegue. Mientras que algunos catéteres de globo de la técnica anterior están "marcados" por los extremos proximal y distal del globo con emplastos visibles, no se encuentra actualmente disponible ningún stent aprobado por la FDA que sea en sí mismo visible mediante los procedimientos de visualización actualmente conocidos cuando los stents se insertan en un vaso.
En consecuencia, existe una necesidad de un aparato de stent mejorado, y de un procedimiento para desplegar el mismo, que: 1) pueda ser utilizado para tratar, de manera efectiva, lesiones de bifurcación, con reducción del riesgo de restenosis o de oclusión de la ramificación lateral, y que se cubran por completo las lesiones de bifurcación con el aparato de stent; 2) pueda ser utilizado para tratar lesiones en una ramificación de una bifurcación mientras se conserva el acceso a la otra ramificación para un tratamiento futuro; 3) pueda ser utilizado para tratar lesiones ostiales; 4) permita un dimensionamiento diferencial de los stents en un aparato de stent bifurcado incluso después de que se haya implantado el stent principal, y 5) pueda ser visualizado fácilmente mediante técnicas de visualización actuales o futuras.
Sumario de la invención
La presente invención se refiere a nuevos aparatos de stent extensibles. Más en particular, la invención se refiere a un aparato de stent que comprende un stent extensible que es adecuado para tratar lesiones de bifurcación, y que puede ser utilizado también para tratar lesiones en el origen de un vaso sanguíneo o de otro órgano. Según se utiliza aquí, el término "vaso" significa cualquier tejido tubular, y no está limitado a vasos del sistema vascular. Los dispositivos construidos de acuerdo con la invención incluyen, de forma unitaria o en combinación, un stent acampanado que comprende una porción acampanada comprimible en su extremo proximal, cuya porción acampanada puede comprender ganchos, malla comprimible o cualquier otro medio de creación de una porción acampanada de ese tipo en el extremo proximal del stent, y un stent principal que comprende al menos una abertura sustancialmente circular situada entre sus extremos proximal y distal. Para facilidad de la visualización, tanto el stent acampanado como el stent principal, pueden comprender materiales que sean susceptibles de visualización, o los stents de la invención pueden estar "marcados" en los extremos con una sustancia susceptible de visualización y el stent principal puede estar también marcado en cualquier abertura. Al menos un dilatador acampanado puede ser extendido a través de al menos una abertura del stent principal, hacia al menos un vaso de una ramificación para tratar lesiones bifurcadas o ramificadas, o los stents de la invención pueden ser insertados individualmente para el tratamiento de lesiones ostiales, o lesiones cercanas a las bifurcaciones que requieran un stent, ya sea en el vaso principal o ya sea en la ramificación, con acceso no obstruido al vaso sin estenosis en la bifurcación. El procedimiento comprende un proceso de dos etapas, utilizado para desplegar tanto el stent principal como el acampanado en un vaso bifurcado, o para desplegar el stent principal solamente en el interior de un vaso bifurcado.
El aparato de stent de la invención puede ser construido a partir de cualquier material no inmuno-reactivo que permita que el aparato se expansione desde una configuración inicial hasta una configuración que se adapte a la forma del vaso o de los vasos en los que se inserta, incluyendo aunque sin limitación cualquiera de los materiales descritos en los stents de la técnica anterior. Se supone que los aparatos de stent de la invención pueden ser construidos, además, con una sustancia que sea observable con métodos de visualización de imágenes, incluyendo aunque sin limitación la resonancia magnética, ultrasonidos, tinte radio-opaco o de contraste, o pueden ser marcados en determinados puntos incluyendo aunque sin limitación los extremos y los alrededores de cualquier abertura o porción acampanada de un stent de la invención, con un material que sea discernible mediante métodos de visualización de imágenes según se ha descrito anteriormente.
Un stent construido de acuerdo con la invención, es adecuado para su implantación en cualquier vaso del cuerpo, incluyendo aunque sin limitación los vasos del sistema cardíaco, el sistema vascular periférico, los vasos carótidas e intracraneales, el sistema venoso, el sistema renal, el sistema biliar, el sistema gastrointestinal, el sistema traqueo-bronquial, el sistema biliar y el sistema genito-urinario.
Los stents de la invención se despliegan utilizando un conjunto de alambres-guía y de catéteres, los cuales son arrastrados después desde el sujeto a continuación del despliegue de los stents. Los stents de la invención pueden ser auto-expansionables para adaptarse a la forma del vaso particular, o pueden ser expandidos con la utilización de catéteres de globo, o mediante cualquier método actualmente conocido o que sea desarrollado en el futuro, que sea efectivo para expansionar los stents de la invención. El stent acampanado de la invención está construido de tal modo que la porción acampanada queda confinada a lo largo de la pared del stent acampanado por medio de una funda que discurre paralela al eje longitudinal del stent acampanado hasta su despliegue, durante el cual se extrae la funda y la porción acampanada se expande según una configuración que se extiende radialmente, al menos en parte, desde el eje longitudinal del stent acampanado.
Así, un objeto de la presente invención consiste en proporcionar un aparato de stent doble que haga posible cubrir completamente el origen de una lesión de bifurcación con un aparato de stent.
Otro objeto consiste en proporcionar un aparato de stent único, para desplegar el mismo, que puede ser utilizado para tratar solamente una ramificación de una lesión de bifurcación, pero que podrá facilitar el tratamiento futuro de la ramificación correspondiente.
Todavía otro objeto consiste en proporcionar un aparato de stent único, que es efectivo en el tratamiento de lesiones ostiales.
Un objeto adicional consiste en proporcionar un procedimiento de inserción del aparato de stent doble extensible tanto en el vaso principal como en la ramificación de una lesión de bifurcación.
Adicionalmente, un objeto de la invención consiste en proporcionar un aparato de stent que sea visualizable durante y después de la inserción.
Estos objetos, y otros objetos, ventajas y características de la invención, podrán ser mejor comprendidos a partir de la descripción detallada que sigue de la invención y de los dibujos que se acompañan.
Breve descripción de los dibujos
La Figura 1 es una representación esquemática del aparato de stent doble de la presente invención, en el que tanto el stent principal como el stent acampanado se encuentran totalmente dilatados;
la Figura 2 es una representación esquemática del stent principal del aparato de la invención según se ha desplegado, sin colocación del stent acampanado;
la Figura 3 es una representación esquemática del stent acampanado del aparato según se ha desplegado, sin el stent principal;
la Figura 4 es una representación esquemática del stent principal del aparato desplegado en el interior de un vaso particular;
la Figura 5 es una representación esquemática del aparato de stent de bifurcación de doble stent, donde el stent principal está desplegado y muestra la colocación del aparato de stent acampanado con anterioridad al despliegue completo del stent acampanado;
la Figura 6 es una representación esquemática del procedimiento. La Figura 6a representa la colocación inicial del stent principal del aparato de stent de bifurcación en el vaso, junto con la inserción del alambre-guía y del catéter de estabilización, para la colocación del stent acampanado en el vaso de ramificación del sujeto;
la Figura 6b es una representación esquemática de la etapa de inflado del stent principal de la invención;
la Figura 6c es una representación esquemática del despliegue del stent acampanado sobre el alambre-guía de la ramificación lateral, a través de una abertura del stent principal, y hacia el vaso de ramificación del sujeto;
la Figura 6d es una representación esquemática de la retirada de la funda protectora del stent acampanado, que muestra la expansión completa de la porción acampanada con anterioridad a la colocación y el despliegue;
la Figura 6e es una representación esquemática del stent acampanado completamente extendido, posicionado en la ramificación mediante el catéter, pero con anterioridad al despliegue;
la Figura 6f es una representación esquemática del stent principal totalmente dilatado, y del stent acampanado totalmente posicionado, donde el stent acampanado está siendo dilatado por inflado del globo, y
la Figura 6g es una representación esquemática del stent doble de bifurcación de la invención totalmente dilatado, posicionado en la bifurcación de un vaso particular.
Las matrices rectilíneas mostradas en los dibujos sólo pretenden mostrar las formas de las superficies, y no ilustran los patrones o apariencias superficies reales de los aparatos de stent de la invención.
Descripción de las realizaciones preferidas
El aparato 10 de stent doble de bifurcación de la presente invención comprende un stent 12 principal, generalmente cilíndrico, y un stent 15 acampanado, generalmente cilíndrico, los cuales se muestran como completamente dilatados en un vaso 8 principal particular y en un vaso 7 de ramificación particular, según se ilustra en la Figura 1.
El stent 12 principal contiene al menos una abertura 16 generalmente circular, situada entre el extremo 26 proximal y el extremo 28 distal del stent 12 principal (Figura 2), cuya abertura está situada sobre la abertura 48 de un vaso de ramificación en una bifurcación 50 de vaso, según se muestra en la Figura 2. Los extremos del dilatador 12 y la abertura, son visualizados durante procedimientos de visualización de imágenes colocando marcadores 56 alrededor de los bordes de la abertura 16 en el stent 12 principal, y en el extremo 26 proximal y el extremo 28 distal del stent principal, según se ha ilustrado en la Figura 4.
El aparato 15 de stent acampanado de la presente invención, comprende un stent acampanado generalmente cilíndrico, que comprende un extremo 30 proximal y un extremo 32 distal, según se muestra en la Figura 3. El extremo 30 proximal comprende una porción acampanada, ilustrada aquí a modo de bucles 18 extendidos, cuya porción acampanada, cuando se dilata, se sitúa en el interior del lumen 58 del vaso 8 principal (Figura 3). Los extremos del stent 15 acampanado y la porción 18 acampanada, son visualizados mediante procedimientos de visualización colocando marcadores 56 alrededor de la porción 18 acampanada y en el extremo 30 proximal y el extremo 32 distal del stent acampanado, según se ha ilustrado en la Figura 5.
Según se muestra en la realización de la invención ilustrada en la Figura 4, un alambre-guía 20 se inserta en el vaso 8 con anterioridad a la inserción del stent 12 principal, y se utiliza para guiar el stent 12 principal hacia su posición en el interior del vaso 8. Con anterioridad a su inserción y dilatación, el stent 12 principal se dispone alrededor del extremo distal de un catéter 48 que puede incluir un globo 24 inflable. El aparato de stent principal/ catéter se rosca a continuación sobre el alambre-guía 20 y hacia el vaso 8. El stent 12 principal se dilata mediante inflado del globo 24 hasta que éste expande las paredes del vaso 8, y de ese modo se fija en su lugar.
Según se muestra en la realización de la invención ilustrada en la Figura 5, con anterioridad a la inserción del stent 15 acampanado, un alambre-guía 36 y un catéter 44 de estabilización, son insertados a través de la abertura 16 en el stent 12 principal, y hacia el vaso de ramificación. El catéter 44 de estabilización se utiliza para situar la abertura del stent 12 principal sobre la abertura 16 de la bifurcación. El alambre-guía 36 se utiliza para guiar el stent 15 acampanado hacia su posición en el interior de un vaso. Durante la inserción y con anterioridad a la dilatación, el stent 15 acampanado se dispone alrededor del extremo distal de un catéter 54 de ramificación que puede incluir un globo 25 inflable, y la porción 18 acampanada de la porción 18 acampanada del stent 15 acampanado se mantiene en posición comprimida por medio de una funda 34 protectora.
En el aparato 10 de stent doble bifurcador de la invención, una vez que el stent 12 principal se ha dilatado y el catéter 44 de estabilización se ha retirado, el stent 15 acampanado se inserta sobre el alambre-guía 36 de ramificación, y a través de la abertura 16 del stent 12 principal sustancialmente según se muestra en la Figura 5, y se fija en su posición mediante la expansión de la porción 18 acampanada, posicionada en el extremo 30 proximal del stent acampanado, según se muestra en las Figuras 1 y 5. El ángulo con el que se fija el stent 15 acampanado depende de la estructura del vaso en el que se inserta el aparato 10 de stent de bifurcación (Figura 1).
El procedimiento innovador de dos etapas para implantar el aparato 10 novedoso de stent doble de bifurcación, empieza con la inserción del alambre-guía 20 principal en el vaso 8 principal particular y a través de la bifurcación 50. Una vez que el alambre-guía 20 principal está en su posición en el vaso 8 principal, el stent 12 principal se monta alrededor de un catéter 48 (que puede comprender también un globo 24), y el catéter 48 y el stent 12 se insertan en el vaso 8 principal. El stent 12 se posiciona de modo que la abertura 16 se encuentra directamente sobre el punto 50 de bifurcación en el vaso particular (Figura 6a). Con el fin de ayudar a tal posicionamiento, un alambre-guía 36 de ramificación y un catéter 44 de estabilización (según se ha representado en las Figuras 5 y 6), se insertan también a través de la abertura 16 del stent 12 principal y en el vaso 7 de ramificación (Figura 6a).
En una realización alternativa del procedimiento, el stent 12 principal, los catéteres 44 y 48, y el alambre-guía 36 de ramificación lateral pueden ser ensamblados con anterioridad a la inserción (con el catéter 44 de estabilización y el alambre-guía de ramificación lateral situados a través de la abertura 16 del stent principal) en el sujeto, y después insertados en el punto 50 de bifurcación del vaso 8 principal simultáneamente, después de lo cual el alambre-guía 36 de ramificación lateral y el catéter 44 de estabilización son roscados en el vaso 7 de ramificación con el fin de alinear apropiadamente la abertura 16 en el stent 12 principal (Figura 6a).
Para fijar el stent 12 principal en la posición deseada en el interior del vaso 8, el stent 12 puede ser dilatado inflando el globo 24 hasta que el stent 12 principal contacta con las paredes del vaso 8 (Figura 6b). Una vez que el stent 12 principal se ha dilatado, los catéteres 44 y 48 son retirados, dejando el stent 12 principal completamente posicionado, y el alambre-guía 20 principal en el vaso principal particular y el alambre-guía 36 de ramificación lateral en el vaso de ramificación particular (Figura 6c).
En la segunda etapa del procedimiento de despliegue, el stent doble de bifurcación de la invención, el catéter 54 de stent acampanado, que contiene el stent 15 acampanado comprimido en una funda 34 protectora y que puede contener además un globo 25 dispuesto alrededor del catéter 54 de stent acampanado y en el interior del stent 15 acampanado comprimido, se insertan en el vaso 7 de ramificación particular alrededor del alambre-guía 36 de ramificación lateral según se muestra en la Figura 6c. El stent 15 acampanado comprimido se posiciona inicialmente de modo que el extremo 30 proximal comprimido del stent acampanado se extiende hacia el lumen 42 del stent 12 principal para facilitar la expansión completa de la porción 18 acampanada tras la retirada de la funda 34 protectora, con anterioridad al posicionamiento final del stent 15 acampanado en la ramificación de la bifurcación (Figura 6c). El extremo 32 distal del stent acampanado está inicialmente posicionado en el interior del vaso 7 de ramificación (Figura 6c). Después de que el extremo 30 proximal del stent acampanado comprimido se coloca apropiadamente en el interior del lumen 42 del stent principal, la funda 34 protectora es retirada del vaso 8, y la porción 18 acampanada del stent 15 acampanado se descomprime para extenderse radialmente, al menos en parte, hasta el eje longitudinal del stent 15 acampanado, como se muestra en la Figura 6d. Después de que la porción 18 acampanada del stent 15 acampanado está en su configuración acampanada (según se muestra en la Figura 6d), el stent 15 acampanado se hace avanzar por la ramificación 7 lateral por su extremo 30 proximal, hasta que al menos una parte de la porción 18 acampanada de la funda 15 acampanada contacta con al menos una porción de un borde de la abertura 16 del stent 12 principal, como se muestra en la Figura 6e. En este ejemplo, un globo 25 se infla con el fin de dilatar el stent 15 acampanado para llevar las paredes del stent 15 acampanado a contactar con las paredes del vaso 7 de ramificación, como se muestra en la Figura 6f. Todos los catéteres y alambres-guía restantes, son retirados a continuación del sujeto, dejando completamente desplegado el aparato 10 de stent doble bifurcador de la invención, que comprende el stent 12 principal con al menos una abertura 16, y el stent 15 acampanado posicionado a través de la abertura 16 en el vaso 7 de ramificación, según se muestra en la Figura 6g.
Cuando se tratan lesiones ostiales, se utiliza el stent 15 solamente, y se posiciona con la utilización de catéteres y de alambres-guía de la manera que se ha descrito en lo que antecede, salvo que no se utiliza ningún catéter de estabilización, y la porción 18 acampanada del stent acampanado se posiciona en el ostium de un vaso, en vez de en una ramificación lateral a través de la abertura 16 de una ramificación principal. Una vez que el stent 15 acampanado ha sido posicionado cerca del ostium de un vaso en particular, la funda 34 protectora se retrae con el fin de permitir que la porción acampanada se expanda completamente, y el stent 15 se hace avanzar más con el extremo proximal del catéter, hasta que los ganchos 18 desplegados entran en contacto con las paredes del vaso particular.
Todos los stents de la invención pueden ser desplegados utilizando los procedimientos mencionados en los párrafos anteriores sin recurrir a ningún catéter de globo. Por ejemplo, un stent auto-expansionable comprimido, contenido en el interior de una funda protectora, podría ser auto-dilatado mediante la retracción de una funda protectora. Pueden existir otros procedimientos de dilatación de los stents de la invención, o pueden estar disponibles en el futuro, y tales procedimientos están contemplados como comprendidos dentro del alcance de esta invención. Mientras en este ejemplo se han utilizado bucles de auto-desplegado para mostrar un medio de creación de una porción acampanada, cualquier otro medio de creación de acampanamiento, tal como, aunque sin limitación, la creación de un rollo de material de stent que se comprime a continuación, está contemplado como comprendido dentro del alcance de esta invención.
Se pretende que la invención incluya todas las modificaciones y variaciones de las realizaciones descritas que caen dentro del alcance de las reivindicaciones de la invención.

Claims (6)

1. Un aparato (10) de stent doble extensible, para su colocación en un vaso (7, 8) de bifurcación, que comprende:
un primer stent (12) generalmente cilíndrico, que posee lados que se extienden entre un primer (26) y un segundo (28) extremos opuestos, y al menos una abertura (16) que está definida en un lateral, y
un segundo stent (15) generalmente cilíndrico, formado separadamente del primer stent (12), y adaptado para extenderse a través de una de dichas aberturas (16) laterales del citado primer stent (12);
en el que dichos primer (12) y segundo (15) stents están construidos, cada uno de ellos, a partir de un material que permite que dichos stents (12, 15) se expansionen para adaptarse a la forma de un vaso (7, 8) particular, y en el que dicho segundo stent (15) posee una porción (18) susceptible de acampanamiento en un extremo (30), que está adaptada para ser acampanada radialmente hacia el exterior hasta contactar con al menos una porción de la abertura (16) del lateral del primer stent (12) cuando el segundo stent (15) es desplegado hacia fuera a través de la abertura (16) del primer stent (12).
2. El aparato (10) de stent de la reivindicación 1, en el que el aparato (10) de stent comprende material biológicamente aceptable.
3. El aparato (10) de stent de la reivindicación 1 ó 2, en el que los stents (12, 15) comprenden un material auto-expansionable.
4. El aparato (10) de stent de la reivindicación 1 ó 2, en el que los stents (12, 15) comprenden un material de globo expansionable.
5. El aparato (10) de stent de cualquiera de las reivindicaciones anteriores, en el que al menos una porción de los stents (12, 15) es visualizable durante y después de la inserción.
6. El aparato (10) de stent de la reivindicación 5, que comprende además marcadores (56) de visualización alrededor del borde de la abertura (16) lateral y por encima de la porción (18) acampanada del segundo stent (15).
ES97911649T 1996-11-04 1997-10-17 Doble stent extensible. Expired - Lifetime ES2273363T3 (es)

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EP1723931B1 (en) 2012-01-04
US6962602B2 (en) 2005-11-08
EP0944366A1 (en) 1999-09-29
ATE539702T1 (de) 2012-01-15
EP1723931A3 (en) 2008-09-10
EP1723931A2 (en) 2006-11-22
US20020156516A1 (en) 2002-10-24
US20060085061A1 (en) 2006-04-20
WO1998019628A1 (en) 1998-05-14
US20020116047A1 (en) 2002-08-22
AU4896797A (en) 1998-05-29
US6210429B1 (en) 2001-04-03
EP0944366A4 (en) 2004-07-07
US20090132028A1 (en) 2009-05-21
DE69736676T2 (de) 2007-01-11
DE69736676D1 (de) 2006-10-26
US20010037137A1 (en) 2001-11-01
EP0944366B1 (en) 2006-09-13
WO1999036002A1 (en) 1999-07-22

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