ES2199953T3 - Bobina de vasooclusion con recubrimiento tabular fibroso tejido. - Google Patents

Bobina de vasooclusion con recubrimiento tabular fibroso tejido.

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Publication number
ES2199953T3
ES2199953T3 ES94900394T ES94900394T ES2199953T3 ES 2199953 T3 ES2199953 T3 ES 2199953T3 ES 94900394 T ES94900394 T ES 94900394T ES 94900394 T ES94900394 T ES 94900394T ES 2199953 T3 ES2199953 T3 ES 2199953T3
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Spain
Prior art keywords
coil
helical coil
fibrous
braided
tubular member
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ES94900394T
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English (en)
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James J. Phelps
Nga Thi Van
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Boston Scientific Ltd Barbados
Boston Scientific Corp
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Boston Scientific Ltd Barbados
Boston Scientific Corp
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    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04C—BRAIDING OR MANUFACTURE OF LACE, INCLUDING BOBBIN-NET OR CARBONISED LACE; BRAIDING MACHINES; BRAID; LACE
    • D04C1/00—Braid or lace, e.g. pillow-lace; Processes for the manufacture thereof
    • D04C1/06—Braid or lace serving particular purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/011—Instruments for their placement or removal
    • 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0073—Quadric-shaped
    • A61F2230/0076—Quadric-shaped ellipsoidal or ovoid
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Neurosurgery (AREA)
  • Textile Engineering (AREA)
  • Manufacturing & Machinery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
  • Investigating Or Analyzing Materials By The Use Of Magnetic Means (AREA)
  • Absorbent Articles And Supports Therefor (AREA)
  • Multicomponent Fibers (AREA)
  • Burglar Alarm Systems (AREA)
  • Treatment Of Fiber Materials (AREA)

Abstract

ESTE INVENTO ESTA EN EL CAMPO DE LOS DISPOSITIVOS DE VASOOCLUSION. MAS PARTICULARMENTE, RELATIVO A UN CARRETE DE VASOOCLUSION (120) QUE DEBE ESTAR SEGMENTADO, SOBRE LA QUE ES LIGADA UN ELEMENTO O CUBIERTA TUBULAR, TRENZADA O ONDULADA, FIBROSA.

Description

Bobina de vasooclusión con recubrimiento tubular fibroso tejido.
Esta invención pertenece al campo de dispositivos de vasooclusión. Más particularmente, se refiere a una bobina de vasooclusión que puede ser continua o segmentada, sobre la cual se fija un recubrimiento o elemento tubular fibroso tejido o trenzado.
Los dispositivos de vasooclusión son implementos quirúrgicos que se colocan dentro del sistema vascular del cuerpo humano, típicamente mediante un catéter, para bloquear el flujo sanguíneo a través del vaso que forma parte del sistema vascular o dentro de un aneurisma que sale del vaso. Un dispositivo vasooclusivo ampliamente utilizado es una bobina de alambre helicoidal que tiene espiras que están dimensionados para acoplar las paredes de los vasos. Las fibras también pueden ser tejidas o estar cruzadas a través de las espiras para proporcionar un substrato para la formación de coágulos y crecimiento de tejidos dentro del sitio elegido. Bobinas que tienen una estructura de esta clase están disponibles comercialmente de forma fácil.
La patente norteamericana número 4.994.069, de Ritchart y otros, describe una bobina vasooclusiva que adopta una configuración helicoidal lineal cuando se estira y una configuración convoluta plegada en reposo. La bobina se introduce en el cuerpo humano en estado estirado. Cuando la bobina alcanza su sitio previsto, la bobina adopta su estado de reposo - el cual es más adecuado para ocluir el vaso - y restringe el flujo sanguíneo más allá del espacio que ocupa.
La solicitud de patente norteamericana con número de serie 07/771.013, de Chee y otros, muestra una bobina de vasooclusión helicoidal a la cual se fijan elementos fibrosos de tal manera que no desalojarán la bobina. Los elementos fibrosos mejoran la capacidad de la bobina para llenar el espacio dentro del sistema vascular y para facilitar la formación de coágulos y el crecimiento de tejido.
Debe tenerse cuidado al crear bobinas fibrosas de combinación, es decir, aquéllas que contienen bobinas metálicas y elementos fibrosos, dado que los elementos fibrosos pueden salirse y moverse hacia los vasos que suministran sangre a un tejido normal. Los elementos fibrosos, dado que no son normalmente radioopacos, son difíciles de encontrar y recuperar si se separan de la bobina metálica. Sin embargo, es deseable aumentar la relación de elemento fibroso respecto de la bobina metálica, dado que el elemento fibroso aumenta la tendencia en el conjunto de bobina a causar embolias y crecimiento de tejido.
El documento US-A-4.820.298 describe un dispositivo vasooclusivo. La bobina helicoidal del dispositivo sirve como un esqueleto al cual se fijan hebras monofilamento flexibles para unir un bucle de la hélice a otro para cerrar el espacio entre las espiras de la hélice.
El documento FR-A-2.671.482 describe una prótesis endovascular para mantener la patencia de un vaso que sigue a una angioplastia. El dispositivo comprende un resorte helicoidal rodeado por una vaina de Dacron para impedir que el resorte perfore un vaso.
El documento US-A-5.151.105 describe un implante de manguito de vaso aplastable que comprende un resorte de bobina posicionado dentro de un manguito cilíndrico de Dacron. Asimismo, se pretende mantener la patencia del vaso dentro del cual se implanta, siendo uno de tales vasos la aorta.
Según la presente invención se proporciona un dispositivo vasooclusivo para ocluir un lugar seleccionado en el sistema vascular, en el que la siguiente característica (b) no se conoce en el estado de la técnica, comprendiendo el dispositivo:
(a) una bobina helicoidal que tiene múltiples espiras y que tiene un primer extremo y un segundo extremo y que tiene al menos una capucha que tapa al menos un extremo de la bobina;
en donde el dispositivo tiene un tamaño que puede introducirse a través del lumen de un catéter vascular;
el dispositivo comprende además:
(b) al menos un miembro tubular fibroso tejido o trenzado que se extiende coaxialmente alrededor del exterior de al menos una parte de la bobina helicoidal y va fijado a la bobina helicoidal en al menos un sitio de la bobina, formando las fibras del miembro tubular tejido o trenzado un ligamento abierto o una trenza abierta;
en el que el miembro tubular fibroso proporciona un substrato para la formación de coágulos y crecimiento de tejidos en el sitio elegido.
Las realizaciones descritas e ilustradas a continuación de dispositivos según la presente invención son deseables porque la relación de material fibroso respecto de material metálico es bastante alta, el material fibroso se mantiene firmemente en su lugar debido a la configuración trenzada o tejida y el dispositivo se coloca fácilmente dentro del sistema vascular del cuerpo.
Se describirán ahora realizaciones del dispositivo según la presente invención, únicamente a modo de ejemplo, con referencia a los dibujos anexos, descritos a continuación.
La figura 1 es una representación esquemática de un sistema global para introducir los dispositivos inventivos dentro del vaso de un cuerpo humano.
Las figuras 2-5 son vistas laterales o vistas parciales en sección transversal de una serie de realizaciones del dispositivo vasooclusivo de la invención.
Las figuras 6-19 son vistas laterales o vistas laterales en sección transversal de una serie de realizaciones del dispositivo vasooclusivo, tales dispositivos estarían de acuerdo con la presente invención si sus bobinas tuvieran al menos una capucha extrema para tapar al menos un extremo de la bobina.
Los dispositivos vasooclusivos de esta invención pueden utilizarse de una manera similar a los descritos en la patente norteamericana número 4.994.069. Brevemente, los dispositivos de bobina pueden suministrarse en forma preenvasada en una cánula estéril que está destinada a acoplar el extremo próximo de un catéter. Según se muestra en la figura 1, una vez que el catéter (100) está en su lugar dentro de un vaso (102) - por ejemplo, el extremo distal (14) del catéter (100) en un aneurisma (106) - la cánula que contiene la bobina se coloca en acoplamiento con el extremo proximal del catéter y las bobinas se transfieren desde el paso de la cánula hacia el paso del catéter ejerciendo fuerza sobre el extremo proximal de la bobina. Se utiliza un dispositivo empujador flexible (108) para empujar la bobina (110) a través del catéter (100) hacia el lugar deseado de liberación de la bobina. La situación de las bobinas (110) puede observarse debido a la opacidad radial de las bobinas metálicas. Una vez en el sitio, las bobinas se hunden singularmente desde el paso del catéter hacia el sitio (106) del vaso.
La figura 2 representa una realización de la bobina vasooclusiva de la invención, generalmente mostrada como (120). El dispositivo vasooclusivo (120) tiene varios componentes: un primer extremo (122) de bobina helicoidal, una capucha (124), un segundo extremo (126) de bobina helicoidal, una capucha (128) y un elemento fibroso tubular trenzado o tejido que se extiende desde las proximidades de la terminación de la primera bobina helicoidal (122) y hacia una posición similar en el segundo extremo (126) de bobina helicoidal. En esta variación, se segmenta la bobina y tiene un hueco por debajo del elemento tubular fibroso (130).
Los extremos (122) y (126) de bobina, varios en esta configuración y en las otras expuestas aquí, se fabricarán típicamente de un material radioopaco tal como platino, tungsteno, oro, plata o aleaciones de los mismos, u otros metales adecuados generalmente radioopacos que, por otra parte, son biológicamente inertes. El diámetro del alambre estará típicamente en el intervalo de 0,013 y 0,13 mm (0,0005 y 0,005 pulgadas). El diámetro de bobina primario resultante normalmente será de 0,2 a 0,46 mm (0,008 a 0,018 pulgadas). Preferiblemente, el diámetro primario de bobina es de 0,38 a 0,46 mm (0,015 a 0,018 pulgadas). Se prefiere una aleación de platino-tungsteno que forma una bobina que tiene un diámetro de 0,38 a 0,46 mm (0,015 a 0,018 pulgadas). La longitud axial de la bobina estará usualmente en el intervalo de 0,5-100 cm., más usualmente 2,5 a 40 cm. La bobina tendrá típicamente 10-71 espiras por centímetro, más típicamente aproximadamente 10-40 espiras por centímetro, las espiras de la bobina pueden ser regulares. El miembro tubular fibrosos tejido o trenzado (130) puede fabricarse a partir de materiales biocompatibles tal como Dacron (poliéster), ácido poliglicólico, ácido poliláctico, fluoropolímeros (politetrafluoretileno), nilón (poliamida) o seda. Las hebras que forman la trenza debe ser razonablemente pesadas, por ejemplo, que tengan una resistencia a la tracción de más de aproximadamente 0,67 N (0,15 libras). Los materiales mencionados, en cuanto que son termoplásticos, pueden fundirse o fusionarse con las bobinas. Alternativamente, pueden pegarse o sujetarse de cualquier otra manera a las bobinas. Materiales preferidos son hebras de Dacron que utilizan el proceso de fusionar para fijar las hebras a la superficie de la bobina.
Las capuchas (124) y (128) mostradas en la figura 1 pueden ser materiales aplicados independientemente tal como colas o soldaduras biocompatibles, pero típicamente se forman únicamente fundiendo las puntas de las bobinas o el polímero trenzado. Los elementos fibrosos pueden ser un mazo de fibras individuales, por ejemplo, entre 5 y 100 fibras por mazo fibroso, preferiblemente de 20 a 30 fibras por mazo, o pueden ser monofilamentos.
La figura 3 muestra una variación adicional del dispositivo inventivo (120) en el cual la trenza (130) se extiende desde las proximidades de los extremos de bobina respectivos (122) y (126). En esta variación, el alambre (132) se coloca entre las capuchas extremas (124) y (128). El alambre (132) puede enrollarse según cualquier configuración incluyendo bobinas rectas o bobinas en forma de C o similares. El alambre (132) se fabrica típicamente de acero inoxidable pero puede fabricarse con otros material apropiados que incluyen aleaciones con memoria de forma tal como Nitinol. El alambre de Nitinol, que tiene la temperatura de transición adecuada, permite que el dispositivo se introduzca a través del catéter de modo lineal y tras elevar la temperatura de la bobina vasooclusiva hasta la temperatura del cuerpo, el alambre adopta su forma previamente seleccionada.
La figura 4 muestra otra variación del dispositivo vasooclusivo (134) de la invención. En esta variación, la bobina (136) no está segmentada, pero su configuración es continua desde un primer extremo (138) hasta un segundo extremo (140). La primera capucha extrema (142) se encuentra en el primer extremo de la bobina y una segunda capucha (144) se encuentra en el segundo extremo. El elemento tubular trenzado o tejido (130) se encuentra en el exterior de la bobina (136) y corre sustancialmente desde el primer extremo (138) de la bobina (136) hasta el segundo extremo (140). La bobina (136) puede recibir una forma específica antes de su introducción en el catéter. Por ejemplo, la bobina puede configurarse previamente para formar una "C" cuando se expulse desde la punta del lumen del catéter. Durante su desplazamiento a través del lumen, estaría limitado por el catéter o mantener una forma lineal.
La figura 5 muestra otra variación de la bobina vasooclusiva de la invención que tiene un primer extremo (122) de bobina con una primera capucha (124) y un segundo extremo (126) de bobina con una capucha (128). Este dispositivo tiene obviamente una parte de bobina segmentada. El recubrimiento tubular trenzado o tejido (146) se extiende desde las proximidades de la punta del primer extremo (122) de bobina hasta la segunda capucha (128). Además, el miembro tubular tiene borlas (148) que se extienden más allá del extremo de la bobina. Esta característica proporciona un área de oclusión adicional y añade muy poco al volumen del dispositivo a medida que atraviesa el lumen del catéter.
La figura 6 muestra un dispositivo vasooclusivo en el cual la trenza (160) está tejida flojamente y se fija únicamente en un extremo (162) de la trenza. La figura 7 muestra un dispositivo similar en el cual se fijan múltiples trenzas fibrosas (162) a una única bobina.
La figura 8 muestra una variación del dispositivo vasooclusivo en el cual una serie de secciones trenzadas independientes (162) se incluyen en una única bobina continua (164). La trenza está fijada a la bobina en localizaciones múltiples en esta variación.
La figura 9 muestra un dispositivo en el cual un elemento fibroso cubre la bobina (164). La parte trenzada fibrosa (166) está construida para tener expuestos elementos de fibra (168) pegados al miembro tubular de fibra. Esta variación mejora la capacidad del dispositivo para llenar efectivamente el espacio en el objetivo dentro del sistema vascular del paciente.
La figura 10 muestra un dispositivo en el cual el elemento exterior fibroso (170) se comprime axialmente antes de su instalación sobre la bobina de modo que se comba (172) desde el medio de la bobina 164). Este pandeo permite que la combinación ocupe más espacio una vez colocado dentro del sistema vascular del paciente.
Las figuras 11 a 17 muestran una variedad de formas de bobina complejas cubiertas con un recubrimiento trenzado o tejido. Los núcleos de bobina en estas variaciones se encuentran, por ejemplo, en la patente norteamericana número 4.994.069 mencionada anteriormente. Estas bobinas adoptan típicamente sólo sus configuraciones convolutas tras su expulsión de la punta del catéter.
La figura 11 muestra una bobina (174) de bucle múltiple sencilla que tiene un pequeño diámetro primario, pero un diámetro secundario grande (150). El diámetro secundario (150) se elige a menudo para coincidir con el del diámetro interior (176) del sitio vascular. La presencia de material trenzado en el exterior de la bobina ayuda a ocluir ese sitio. Similarmente, la figura 12 muestra una bobina (178) que tiene una configuración como la de la figura 13 excepto en que se le da un grado añadido de torsión para permitir la adopción de un diseño similar a una flor simétrica grande tras su relajación después de abandonar la punta del catéter. Esta configuración, con su cubierta trenzada (180), permite llenar un espacio vascular grande con una bobina y cuyo llenado se mejora por el recubrimiento trenzado o tejido.
La figura 13 muestra aún una variación adicional de la invención. En esta variación, la bobina (182) se ha rizado previamente (152) para condicionar con anterioridad a la bobina para que forme una configuración aleatoria tras su relajación. De nuevo, el recubrimiento trenzado o tejido (184) mejora la capacidad de esta bobina aleatoria (186) para ocluir el sitio en el cual se coloca.
La figura 14 muestra una variación de la invención que tiene dos diámetros secundarios. La bobina está condicionada previamente de modo que tiene un mayor diámetro secundario (154) y un menor diámetro secundario (156). De esta manera, el mayor diámetro secundario (154) puede elegirse para que coincida con el del sitio vascular que se ha de tratar. El menor diámetro secundario (156) finaliza por tanto en el área media de la región vascular objetivo. La colocación de la parte de la bobina que tiene un menor diámetro secundario lejos de la pared del vaso mejora la propensión de la bobina a ocluir el sitio. La presencia del recubrimiento trenzado o tejido (188) en el exterior de la bobina aumenta adicionalmente la tendencia de la combinación bobina-trenza a la producción de una embolia.
La figura 15 muestra una variación de la invención mostrada en la figura 12. En este caso, la bobina cubierta (192) trenzada (190) y relajada forma únicamente una "hoja de trébol". Se cree que es algo más controlable desde un punto de vista de colocación físico y en consecuencia tiene gran uso para los médicos asistentes. De nuevo la presencia del recubrimiento trenzado mejora la facilidad del conjunto de bobina para producir material de oclusión.
La figura 16 muestra un diseño de bobina similar de doble bucle (194) con trenza (196) y la figura 19 muestra la bobina (198) en forma de C con la trenza (200) antes mencionada. Los dispositivos de las figuras 17 y 18 pueden dimensionarse de tal modo que aniden herméticamente dentro de la cavidad vascular o vaso que se ha de ocluir por el dispositivo.
La figura 18 muestra una variación en la que un recubrimiento 158 tejido o trenzado exterior único rodea una serie de bobinas individuales.
La figura 19 muestra otra variación en la que se utilizan bobinas (160) para unir una serie de cubiertas trenzadas 150. Estas configuraciones permiten al dispositivo de oclusión mezclarse aleatoriamente en el sitio para ocluir eficientemente la abertura vascular.
Las modificaciones de las variaciones antes descritas para realizar la invención que son obvias para los versados en los campos del diseño de dispositivos médicos en general, y específicamente dispositivos de vasooclusión, se pretende que estén dentro del alcance de las siguientes reivindicaciones.

Claims (15)

1. Un dispositivo vasooclusivo (120) para ocluir un lugar seleccionado en el sistema vascular, comprendiendo el dispositivo: (a) una bobina helicoidal (122, 126, 136) que tiene múltiples espiras y que tiene un primer extremo y un segundo extremo y que tiene al menos una capucha extrema (124, 128) que tapa al menos un extremo de la bobina, en donde el dispositivo tiene un tamaño que puede introducirse a través del paso de un catéter vascular y donde el dispositivo comprende además: (b) al menos un miembro tubular fibroso tejido o trenzado (130, 146) que se extiende coaxialmente alrededor del exterior de al menos una parte de la bobina helicoidal (122, 126, 136) y va fijado a la bobina helicoidal en al menos un sitio de la bobina, formando las fibras del miembro tubular tejido o trenzado un ligamento abierto o una trenza abierta; en el que el miembro tubular fibroso (130, 146) proporciona un substrato para la formación de coágulos y crecimiento de tejidos en el sitio elegido.
2. Un dispositivo vasooclusivo según la reivindicación 1, en el que la bobina helicoidal (122, 126, 136) tiene múltiples espiras que comprenden alambre que tiene un diámetro de alambre de entre 0,013 y 0,13 mm (0,0005 y 0,005 pulgadas).
3. El dispositivo según la reivindicación 1 o la reivindicación 2, en el que la bobina helicoidal (122, 126) está segmentada.
4. El dispositivo según la reivindicación 1 o la reivindicación 2, en el que la bobina helicoidal (136) es continua.
5. El dispositivo según una cualquiera de las reivindicaciones precedentes, en el que el miembro tubular fibroso (146) tiene un interior y un exterior y el dispositivo comprende adicionalmente borlas (148) que se extienden más allá del exterior de dicho miembro tubular.
6. El dispositivo según una cualquiera de las reivindicaciones precedentes, en el que la bobina helicoidal adopta una configuración aleatoria cuando se utiliza.
7. El dispositivo según una cualquiera de las reivindicaciones 1 a 5, en el que la bobina helicoidal adopta en reposo una configuración de hoja de trébol.
8. El dispositivo según una cualquiera de las reivindicaciones 1 a 5, en el que la bobina helicoidal adopta en reposo una configuración arrollada regular.
9. El dispositivo según una cualquiera de las reivindicaciones 1 a 5, en el que la bobina helicoidal adopta en reposo una forma arrollada que tiene dos diámetros secundarios.
10. El dispositivo según una cualquiera de las reivindicaciones precedentes, que incluye miembros tubulares fibrosos múltiples.
11. El dispositivo según la reivindicación 10, en el que cada miembro tubular tiene un primer extremo y un segundo extremo.
12. El dispositivo según la reivindicación 11, en el que los extremos primeros de los miembros tubulares están fijados a la bobina helicoidal.
13. El dispositivo según la reivindicación 12, en el que los extremos segundos de los miembros tubulares también están fijados a la bobina helicoidal.
14. El dispositivo según la reivindicación 13, en el que los miembros tubulares están comprimidos axialmente en el eje entre sus extremos primero y segundo y se comban desde la bobina.
15. El dispositivo según cualquiera de las reivindicaciones precedentes, en el que el dispositivo tiene un diámetro de 0,20 a 0,46 mm (0,008 a 0,018 pulgadas).
ES94900394T 1992-10-26 1993-10-26 Bobina de vasooclusion con recubrimiento tabular fibroso tejido. Expired - Lifetime ES2199953T3 (es)

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JPH06319743A (ja) 1994-11-22
AU659970B2 (en) 1995-06-01
WO1994009705A1 (en) 1994-05-11
EP0618783A4 (en) 1995-06-14
AU5540094A (en) 1994-05-24
CA2109283C (en) 1996-10-22
EP0618783B1 (en) 2003-07-30
ATE245941T1 (de) 2003-08-15
DE69333125T2 (de) 2004-04-15
JP2553309B2 (ja) 1996-11-13
IL107344A0 (en) 1994-01-25
EP0618783A1 (en) 1994-10-12
TW251231B (es) 1995-07-11
DE69333125D1 (de) 2003-09-04
US5522822A (en) 1996-06-04
CA2109283A1 (en) 1994-04-27
US5382259A (en) 1995-01-17

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