ES2386239T3 - Prótesis cardiovalvular atraumática - Google Patents
Prótesis cardiovalvular atraumática Download PDFInfo
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- ES2386239T3 ES2386239T3 ES09160105T ES09160105T ES2386239T3 ES 2386239 T3 ES2386239 T3 ES 2386239T3 ES 09160105 T ES09160105 T ES 09160105T ES 09160105 T ES09160105 T ES 09160105T ES 2386239 T3 ES2386239 T3 ES 2386239T3
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- prosthesis
- cardiovalvular
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- valve
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- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
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- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/243—Deployment by mechanical expansion
- A61F2/2433—Deployment by mechanical expansion using balloon catheter
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- 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
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
Abstract
Una prótesis cardiovalvular (10) adaptada para su instalación mínimamente invasiva en una zona de implantación de un paciente, presentando la zona de implantación un ánulo (16), un seno de Valsalva (VS), y una túnica íntima aórtica, comprendido la prótesis: una estructura (400) de anclaje que presenta una configuración radialmente abatida para su instalación y una configuración radialmente expandida para su despliegue; una válvula (410) acoplada a la estructura (400) de anclaje y configurada de tal manera que, en la configuración expandida, la válvula permite el flujo sanguíneo a través de la luz en una primera dirección y sustancialmente impide el flujo sanguíneo a través de la luz en una segunda dirección genéricamente opuesta a la primera dirección; en la que la estructura (400) de anclaje incluye una porción genéricamente cilíndrica adaptada para encajar con una pared anular del vaso en la zona de implantación; en la que la porción genéricamente cilíndrica incluye una porción (435) del flujo de salida adaptada para encajar con la pared del vaso en un emplazamiento distal con respecto al seno de Valsava (VS); en la que, en la configuración expandida, la porción (435) del flujo de salida se ahúsa hacia dentro hacia un extremo distal, de tal manera que el extremo distal imprime menos fuerza que una porción proximal sobre la túnica íntima aórtica, estando la prótesis cardiovalvular caracterizada porque la porción (435) del flujo de salida incluye un anillo proximal (465) del flujo de salida y un anillo distal (460) del flujo de salida, en la que el anillo distal (460) del flujo de salida presenta una configuración ahusada, de tal manera que un extremo distal del anillo distal (460) del flujo de salida tiene un diámetro menor que un extremo proximal del anillo distal (460) del flujo de salida, y porque el extremo distal del anillo distal (460) del flujo de salida está dispuesto entre aproximadamente 0, 5 y aproximadamente 3 mm más próximo a un eje geométrico longitudinal (X1) de la estructura (400) de anclaje de lo que lo que está un extremo distal del anillo proximal (465) del flujo de salida.
Description
Prótesis cardiovalvular atraumática
La presente invención se refiere al campo de las prótesis cardiovalvulares.
Más concretamente, la presente invención se refiere a una prótesis aplicable en un procedimiento de implantación mínimamente invasivo que incorpora una estructura de anclaje en forma de stent. Dicha prótesis se conoce, por ejemplo, a partir del documento WO-A-2008/070797.
La aorta está compuesta por tres capas. La capa que está en contacto directo con el flujo sanguíneo es la túnica íntima, generalmente denominada íntima. Esta capa está compuesta principalmente por células endoteliales. La capa siguiente es la túnica media, conocida como media. Esta “capa intermedia” está compuesta por células moleculares lisas y por tejido elástico. La capa externa (la más alejada del flujo sanguíneo) es conocida como la túnica adventicia o adventicia. Esta capa está compuesta por tejido conjuntivo.
Las prótesis cardiovalvulares expansibles algunas veces, tras su inserción, son expandidas mediante balón o de otro modo. El avance de la introducción del balón presiona las porciones autoexpansibles o expansibles mediante balón de la prótesis cardiovalvular contra el seno de Valsalva, hacia arriba por la aorta ascendente y / o hacia abajo hasta interior del ánulo con el fin de anclar adecuadamente la prótesis. En algunos casos, el avance del sistema de balón puede debilitar la túnica íntima, la túnica media y / o la túnica adventicia. Por otro lado, como resultado de la expansión y contracción del corazón y del movimiento de la prótesis a lo largo del tiempo, la prótesis puede frotar las capas o la aorta y puede desgarrar la túnica íntima, la túnica media y / o la túnica adventicia provocando una disección aórtica. Otros factores, como por ejemplo la edad del paciente o una predisposición natural a desgarros aórticos pueden contribuir a un episodio que conduzca a una disección aórtica y / o a una ruptura aórtica.
De acuerdo con diversas formas de realización, la presente invención es una prótesis cardiovalvular configurada para facilitar el flujo de sangre a través de una válvula cardíaca tal y como se define en las reivindicaciones adjuntas. La prótesis cardiovalvular está configurada para ser instalada en una zona de implantación de una manera mínimamente invasiva, e incluye una estructura de soporte de anclaje expansible que presenta una porción de flujo de salida que incluye un extremo distal, estando la porción de flujo de salida configurada para incurvarse hacia dentro en dirección a un eje geométrico central de la prótesis de manera que el extremo distal de la estructura de soporte de anclaje quede incurvado a distancia del punto de implantación.
De acuerdo con algunas formas de realización, la estructura de soporte de anclaje puede ser expansible por balón. De acuerdo con otras formas de realización, la estructura de soporte de anclaje puede ser autoexpansible. En algunas formas de realización la porción de flujo de salida puede ser lisa y estar desprovista de bordes rugosos. En otras formas de realización adicionales, una superficie exterior de la porción de flujo de salida puede estar provista de un revestimiento lubrificante.
Aunque se divulgan múltiples formas de realización, otras formas de realización adicionales de la presente invención resultarán evidentes a los expertos en la materia a partir de la descripción detallada subsecuente, la cual muestra y describe formas de realización ilustrativas de la invención. De acuerdo con ello, los dibujos y la descripción detallada deben ser considerados como de naturaleza ilustrativa y no restrictiva.
Breve descripción de los dibujos
La FIG. 1 es una vista en sección transversal de una aorta de un corazón humano con una prótesis cardiovalvular expansible implantada dentro o en posición adyacente a una válvula aórtica.
Las FIGS. 2A y 2B son vistas en perspectiva de una prótesis cardiovalvular.
La FIG. 3 es una vista en perspectiva de una prótesis cardiovalvular.
Las FIGS. 4A y 4B son vistas en perspectiva de una prótesis cardiovalvular de acuerdo con formas de realización de la presente invención.
Aunque la invención es susceptible de diversas modificaciones y formas alternativas, formas de realización específicas se han mostrado a modo de ejemplo en los dibujos y se describen con detalle en las líneas que siguen. La invención, sin embargo, no pretende limitar la invención a las formas de realización concretas descritas. Por el contrario, la invención pretende amparar todas las modificaciones, equivalentes y alternativas que se incluyan en el alcance de la presente invención tal y como queda definida por las reivindicaciones adjuntas.
La FIG. 1 es una vista esquemática de una prótesis cardiovalvular expansible 10 implantada dentro o en posición adyacente a un ánulo aórtico 16 de una aorta ascendente 6. Tal y como se muestra en la FIG. 1, la aorta ascendente está acoplada al ventrículo izquierdo 18. Durante su funcionamiento normal, el ventrículo izquierdo 18 bombea la sangre que sale del corazón a través del ánulo aórtico 16 para penetrar en la aorta ascendente 6 ( tal y como se indica mediante las flechas en la FIG. 1).
Tal y como se muestra, así mismo, en la FIG. 1, la prótesis cardiovalvular expansible 10 incluye una estructura 24 de anclaje o soporte expansible acoplada a una válvula protésica 30. La prótesis cardiovalvular 10 está indicada para su implantación dentro de o en posición adyacente a una zona intraluminal valvular utilizando técnicas de instalación endovascular conocidas por los expertos en la materia. La zona intraluminar valvular ejemplar incluye los ánulos de la válvula aórtica 16 (tal y como se muestra en la FIG. 1), de la válvula tricúspide, de la válvula pulmonar y de la válvula mitral del corazón de un paciente. Tal y como se muestra en la FIG. 1, la prótesis cardiovalvular 10 puede ser implantada de manera que los elementos anulares 32a y 32b de la estructura 24 de soporte de anclaje ocupen, respectivamente, las posiciones proximal y distal de los senos de Valsalva, VS, formando el extremo proximal abocinado del miembro anular 32a la entrada proximal del lumen definido por la estructura 24 de soporte de anclaje de la prótesis 10.
Tal y como se muestra en la FIG. 1, la prótesis cardiovalvular 10 incluye una estructura 24 de soporte de anclaje acoplada a una válvula protésica 30, de la que se conocen muchos ejemplos en la técnica. La válvula protésica 30 puede estar configurada para ser implantada dentro de una vía de paso de fluido de una luz del cuerpo para regular el flujo de un fluido corporal a su través en una sola dirección. Luces ejemplares incluyen válvulas cardiacas, arteriales o venosas. La válvula protésica 30 está configurada para ser implantada dentro de o en posición adyacente a la válvula protésica. La válvula protésica 30 está construida a partir de materiales biocompatibles para reducir al mínimo cualquier reacción corporal adversa a la implantación de la válvula protésica 30 en la zona de implantación seleccionada. La válvula cardiaca protésica 30 incluye una pluralidad de valvas 34 de la válvula. Tal y como se muestra en la FIG. 1, la válvula protésica 30 incluye tres valvas 34 de la válvula. La válvula protésica 30 puede incluir hasta seis valvas de la válvula. Las valvas 34 de la válvula son plegables entre una configuración cerrada (mostrada en la FIG. 1), en la cual el flujo de fluido a través de la vía de paso de la válvula resulta restringido, y una configuración abierta en la cual el flujo de fluido a través de la válvula de paso de la válvula resulta expedito. Las valvas 34 de la válvula son presionadas hacia una configuración cerrada, restrictiva del flujo. Válvulas cardiacas protésicas ejemplares se muestran y describen en la Publicación estadounidense 2006/0178740 y en la Publicación estadounidense 2005/0197695.
Las FIGS. 2A a 4B son vistas en perspectiva de unas estructuras 100, 200, 300 y 400 de soporte o anclaje de acuerdo en parte con diversas formas de realización de la presente invención. Las estructuras 100, 200, 300 y 400 de soporte o anclaje presentan una configuración en forma de stent y están adaptadas para soportar una válvula cardiaca protésica. Las estructuras 100, 200, 300 y 400 de anclaje están adaptadas para expandirse desde una configuración abatida o comprimida hasta una configuración expandida. Tras la expansión, las estructuras 100, 200, 300 y 400 de anclaje quedan constreñidas por la pared interior del vaso de la zona de implantación. Las estructuras 100, 200, 300 y 400 de anclaje expandidas aplican una fuerza de expansión radial suficiente sobre la superficie interior de la zona de implantación para asegurar y estabilizar las estructuras 100, 200, 300 y 400 de anclaje de la zona de implantación.
Las estructuras 100, 200, 300 y 400 de anclaje pueden ser expansibles mediante balón o ser autoexpansibles. Al menos una porción de las estructuras 100, 200, 300 y 400 de anclaje puede ser expandida utilizando un balón inflable. El avance mediante balón presiona las porciones expansibles de las estructuras 100, 200, 300 y 400 de anclaje contra el seno de Valsalva, hacia arriba por la aorta ascendente, y / o hacia abajo hasta el interior del ánulo de la válvula con el fin de anclar de manera adecuada la prótesis incluyendo la estructura de soporte de anclaje acoplada a una válvula protésica expansible en la zona de implantación.
Las estructuras 100, 200, 300 y 400 de anclaje están fabricadas a partir de un metal o un plástico biocompatible. Las estructuras 100, 200, 300 y 400 de anclaje pueden estar constituidas a partir de una diversidad de materiales entre los cuales se incluyen el acero inoxidable, el titanio, el platino, el oro y otros metales biocompatibles. Así mismo, pueden ser empleados materiales plásticos, poliméricos y termoplásticos con memoria de la forma que sean inertes dentro del cuerpo. Las estructuras 100, 200, 300 y 400 de anclaje pueden estar constituidas a partir de Nitinol u otras aleaciones con memoria de la forma similares.
Las FIGS. 2A y 2B son vistas en perspectiva de las estructuras 100 y 200 de anclaje. Tal y como se muestra, las estructuras 100 y 200 de anclaje están adaptadas para ser ancladas a una válvula cardiaca protésica expansible. Las estructuras 100 y 200 de anclaje presentan una configuración en forma de stent y pueden ser expansibles mediante balón o ser autoexpansibles. Cada una de las estructuras 100 y 200 de anclaje incluyen una porción 130, 230 de entrada del flujo y una porción 135, 235 de salida del flujo (por ejemplo, un anillo de salida del flujo). Las porciones 130, 230 de entrada del flujo están dimensionadas y conformadas para quedar situadas dentro de y fijadas en posición adyacente a un ánulo de válvula natural.
Las porciones 135, 235 del flujo de salida están situadas en posición distal con respecto a un extremo del flujo de salida de una válvula cardiaca protésica expansible. En algunas formas de realización, las porciones 135, 235 del flujo de salida están configuradas para expandirse dentro de los senos de Valsalva apoyándose contra las paredes de los senos cuando están en la configuración expandida. Las porciones 135, 235 del flujo de salida están configuradas para expandirse hacia arriba por dentro de la aorta ascendente (esto es, en posición distal con respecto a los senos de Valsalva). Tal y como se muestra en la FIG. 2A, la porción 135 del flujo de salida de la estructura 100 de anclaje está configurada de tal manera que presenta una porción 140 de cuello descendente situada entre un extremo distal 160 y una porción principal 145. Tal y como se muestra en la FIG. 2B, la porción 235 del flujo de salida está configurada de tal manera que se incurva hacia dentro en dirección al eje geométrico central X1 de la estructura 200 de anclaje. La función de esta configuración de estrechamiento o ahusamiento de las porciones 135 y 235 del flujo de salida consistirá en reducir al mínimo el trauma a la pared del vaso (por ejemplo, la túnica íntima aórtica) como resultado de la expansión y contracción continuadas del corazón y del movimiento de las porciones 135, 235 del flujo de salida contra la pared del vaso.
La FIG. 3 es una vista en perspectiva de una estructura 300 de anclaje expansible. Tal y como se muestra en la FIG. 3, la porción 330 del flujo de entrada puede estar abocinada en una dirección hacia fuera a distancia del eje geométrico central X1 de la estructura 300 de anclaje. La porción abocinada 330 del flujo de entrada está expandida en una posición ligeramente proximal con respecto al ánulo de la válvula y facilita el anclaje de la prótesis en la zona de implantación. La porción 335 del flujo de salida se extiende distalmente desde un extremo del flujo de salida de una válvula cardíaca protésica expansible acoplada a la estructura 300 de anclaje. La porción 335 del flujo de salida presenta una configuración bulbosa que está adaptada para expandirse radialmente y conformarse a las paredes de la aorta asegurando y estabilizando aún más la estructura 300 de soporte y cualquier válvula a la cual esté acoplada en la zona de implantación. Así mismo, la porción 335 del flujo de salida se incurva a distancia del punto de contacto en la zona de implantación y hacia el eje geométrico central de la estructura 300 de anclaje, de tal manera que un extremo distal 360 presenta un diámetro reducido, lo cual reduce al mínimo la fuerza aplicada contra la pared del vaso (por ejemplo, la túnica íntima aórtica) durante el movimiento continuado provocado por el latido del corazón.
Las FIGS. 4A y 4B son vistas en perspectiva de una estructura 400 de anclaje acoplada a una válvula cardiaca protésica 410. De acuerdo con algunas formas de realización, tal y como se muestra en las FIGS. 4A y 4B, la estructura 400 de anclaje incluye uno o más apéndices 450 de anclaje configurados para anclar y estabilizar la estructura 400 de anclaje en la zona de implantación. Una estructura de anclaje ejemplar del tipo indicado se muestra y describe en la Publicación de Patente estadounidense pendiente con la actual y de titularidad compartida No. 2006/0178740 titulada “Prótesis Cardiovalvular” [“Cardiac – Valve Prothesis”], depositada el 10 de febrero de 2006. Los apéndices 450 de anclaje están dimensionados y conformados para proyectarse por el interior de los senos de Valsalva cuando la estructura de anclaje está en su configuración expandida. La porción 435 del flujo de salida presenta una configuración en forma de stent y está adaptada para contactar con la pared del vaso en un emplazamiento distal con respecto al seno de Valsalva. Tal y como se muestra, la porción 435 del flujo de salida está incurvada hacia dentro desde la pared del vaso hacia el eje geométrico central X1 de la estructura 400 de anclaje.
De acuerdo con una forma de realización, la porción 435 del flujo de salida incluye dos anillos 460 y 465 del flujo de salida acoplados entre sí. El anillo proximal 460 del flujo de salida está dispuesto en posición proximal con respecto al anillo distal 465 del flujo de salida. Tal y como se muestra en las FIGS. 4A y 4B, el anillo proximal 465 del flujo de salida se extiende genéricamente en paralelo con respecto al eje geométrico longitudinal de la estructura 400 de soporte. El anillo distal 460 del flujo de salida, por otro lado, se estrecha en cuanto a su diámetro en dirección distal. De acuerdo con algunas formas de realización, el anillo distal 460 del flujo de salida se extiende genéricamente en sentido lineal desde el extremo distal del anillo proximal 465 del flujo de salida hasta un emplazamiento terminal distal que presenta un diámetro reducido. De acuerdo con otras formas de realización, el anillo distal 460 del flujo de salida se extiende a lo largo de una trayectoria curvada, cóncava (desde la perspectiva del eje geométrico longitudinal) en dirección distal. De acuerdo con una forma de realización, el extremo distal del anillo distal 460 del flujo de salida está dispuesto entre aproximadamente 0,5 y aproximadamente 3 mm más próximo al eje geométrico longitudinal de lo que lo está el extremo distal del anillo proximal 465 del flujo de salida.
En diversas formas de realización ejemplares, el anillo distal 460 del flujo de salida se ahúsa hacia dentro, de manera genéricamente lineal, en un ángulo de entre aproximadamente 5 y aproximadamente 40 grados con respecto al eje geométrico central X1. En algunas formas de realización de la invención, el anillo distal 460 del flujo de salida se ahúsa hacia dentro de forma genéricamente lineal, en un ángulo de entre aproximadamente 15 y aproximadamente 25 grados. En otras formas de realización adicionales, el anillo distal 460 del flujo de salida se ahúsa hacia dentro, de una forma genéricamente lineal, en un ángulo de aproximadamente 20 grados. En diversas formas de realización de la invención, el anillo proximal 465 del flujo de salida y el anillo distal 460 del flujo de salida tienen genéricamente la misma longitud de entre aproximadamente 2 y aproximadamente 5 cada uno. En una forma de realización ejemplar, el anillo proximal 465 del flujo de salida y el anillo 460 del flujo de salida tienen una longitud combinada de aproximadamente 7 mm.
De acuerdo con diversas formas de realización de la presente invención, las porciones de entrada de flujo de las estructuras de anclaje descritas con anterioridad pueden incluir un anillo de sutura adaptado para anclar y fijar aún más las prótesis en la zona de implantación. De acuerdo con otras formas de realización adicionales, las válvulas protésicas acopladas a las estructuras de anclaje pueden incluir un manguito, una faldilla, u otro medio de estanqueidad en la base de la válvula expansible para proporcionar una junta de estanqueidad eficiente entre la prótesis y la zona de implantación impidiendo las fugas de fluido en la zona de implantación.
De acuerdo con diversas formas de realización de la presente invención, la superficie exterior de la estructura de anclaje es lisa y desprovista de bordes rugosos. En algunas formas de realización, los extremos distales 160, 260, 360 y 460 de las porciones 134, 235, 335 y 435 del flujo de salida de las estructuras 100, 200, 300 y 400 de anclaje son romos y desprovistos de bordes afilados para reducir el riesgo de desgarrar y rasgar la pared del vaso en la zona de implantación. De acuerdo con otras formas de realización, las porciones 135, 235, 335 y 435 del flujo de salida pueden incluir un revestimiento lubrificante. En algunas formas de realización, puede ser aplicado un revestimiento lubrificante a la superficie exterior de la entera estructura 100, 200, 300 y 400 de soporte de anclaje. Un revestimiento lubrificante ejemplar es el teflón (politetrafluoroetileno). Así mismo, pueden ser aplicados otros revestimientos lubrificantes conocidos por los expertos en la materia a la superficie exterior de las porciones 135, 235, 335 y 435 del flujo de salida de las estructuras 100, 200, 300 y 400 de anclaje. De acuerdo con otra forma de realización, las porciones 135, 235, 335 y 435 del flujo de salida están cubiertas con un material protector para impedir el trauma a o el rasgado de la túnica íntima aórtica.
De acuerdo con algunas formas de realización, las porciones 135, 235, 335 y 435 del flujo de salida están conformadas para reducir el cizallamiento de las células sanguíneas que pasan sobre o a través de la porción inferior y puede reducir la turbulencia del flujo sanguíneo a través de la prótesis.
La prótesis cardiovalvular 10 de la presente invención puede ser instalada en la zona de implantación utilizando cualquiera de entre las muchas técnicas conocidas en la materia. Por ejemplo, puede ser instalada mediante un catéter de instalación utilizando técnicas y utensilios conocidos por los expertos en la materia. Un utensilio de fruncido u otro dispositivo similar conocido por los expertos en la materia puede ser utilizado para abatir radialmente la válvula cardíaca protésica que incluya la estructura de anclaje. Después de que se haya provocado la transición de la prótesis desde una posición expandida hasta una posición abatida, la prótesis puede ser cargada dentro de un catéter de instalación. La prótesis puede, a continuación, ser instalada en una zona de implantación de destino dentro del corazón de un paciente, utilizando procedimientos y técnicas conocidos, de una manera mínimamente invasiva. El catéter de instalación es, a continuación, retirado facilitando la expansión automática de la prótesis incluyendo la estructura de soporte desde su configuración abatida hasta su configuración expandida.
Un balón inflable puede ser insertado y expandido dentro de la válvula cardíaca protésica facilitando la expansión de la válvula y de la estructura de soporte en la zona de implantación. La estructura del stent expansible está dimensionada y conformada para impedir un “locus minoris resistentiae” en una pared aórtica cuando la prótesis es expandida mediante balón.
Pueden llevarse a cabo diversas modificaciones y adiciones en las formas de realización ejemplares analizadas sin apartarse del alcance de la presente invención. Por ejemplo, aunque las formas de realización descritas en las líneas anteriores se refieren a características distintivas específicas, el alcance de la presente invención incluye, así mismo, formas de realización que presentan combinaciones diferentes de características distintivas y formas de realización que no incluyen todas las características distintivas descritas. De acuerdo con ello, el alcance de la presente invención pretende abarcar todas las alternativas, modificaciones y variantes referidas en cuanto se incluyen en el alcance de las reivindicaciones.
Claims (13)
- REIVINDICACIONES1.-Una prótesis cardiovalvular (10) adaptada para su instalación mínimamente invasiva en una zona de implantación de un paciente, presentando la zona de implantación un ánulo (16), un seno de Valsalva (VS), y una túnica íntima aórtica, comprendido la prótesis:una estructura (400) de anclaje que presenta una configuración radialmente abatida para su instalación y una configuración radialmente expandida para su despliegue;una válvula (410) acoplada a la estructura (400) de anclaje y configurada de tal manera que, en la configuración expandida, la válvula permite el flujo sanguíneo a través de la luz en una primera dirección y sustancialmente impide el flujo sanguíneo a través de la luz en una segunda dirección genéricamente opuesta a la primera dirección;en la que la estructura (400) de anclaje incluye una porción genéricamente cilíndrica adaptada para encajar con una pared anular del vaso en la zona de implantación;en la que la porción genéricamente cilíndrica incluye una porción (435) del flujo de salida adaptada para encajar con la pared del vaso en un emplazamiento distal con respecto al seno de Valsava (VS);en la que, en la configuración expandida, la porción (435) del flujo de salida se ahúsa hacia dentro hacia un extremo distal, de tal manera que el extremo distal imprime menos fuerza que una porción proximal sobre la túnica íntima aórtica,estando la prótesis cardiovalvular caracterizada porquela porción (435) del flujo de salida incluye un anillo proximal (465) del flujo de salida y un anillo distal (460) del flujo de salida,en la que el anillo distal (460) del flujo de salida presenta una configuración ahusada, de tal manera que un extremo distal del anillo distal (460) del flujo de salida tiene un diámetro menor que un extremo proximal del anillo distal (460) del flujo de salida, y porque el extremo distal del anillo distal (460) del flujo de salida está dispuesto entre aproximadamente 0,5 y aproximadamente 3 mm más próximo a un eje geométrico longitudinal (X1) de la estructura (400) de anclaje de lo que lo que está un extremo distal del anillo proximal(465) del flujo de salida.
- 2.-La prótesis de la reivindicación 1, en la que la zona de implantación es el ánulo aórtico (16) del paciente.
- 3.-La prótesis de la reivindicación 1, en la que el anillo distal (460) del flujo de salida define una configuración incurvada cóncava.
- 4.-La prótesis de la reivindicación 1, que comprende así mismo una válvula cardíaca protésica (410) que incluye tres valvas coaptantes, estando la válvula acoplada a la estructura de soporte de anclaje.
- 5. La prótesis de la reivindicación 1, en la que la estructura (24; 400) de anclaje está configurada para ser autoexpansible.
- 6.-La prótesis cardiovalvular de la reivindicación 1, en la que la estructura de anclaje es una estructura de stent y la porción (435) del flujo de salida está incurvada a distancia de la túnica íntima aórtica.
- 7.-La prótesis cardiovalvular de la reivindicación 1, en la que la porción (435) del flujo de salida es roma.
- 8.-La prótesis cardiovalvular de la reivindicación 1, en la que la porción (435) del flujo de salida está cubierta con un revestimiento o material protector.
- 9.-La prótesis cardiovalvular de acuerdo con la reivindicación 7, en la que el extremo distal está configurado para no desgarrar el tejido en la zona de implantación.
- 10.-La prótesis cardiovalvular de acuerdo con la reivindicación 1, en la que la porción (435) del flujo de salida está dimensionada para reducir al mínimo el cizallamiento de las células sanguíneas que pasan por la porción del flujo de salida.
- 11.-La prótesis cardiovalvular de acuerdo con la reivindicación 1, en la que la porción (435) del flujo de salida está configurada para reducir al mínimo la turbulencia del flujo sanguíneo a través de la prótesis.
- 12.-La prótesis cardiovalvular de la reivindicación 1, en la que una superficie exterior de la porción (435) del flujo de salida es lisa y está desprovista de bordes rugosos.
- 13.-La prótesis cardiovalvular de la reivindicación 1, en la que la superficie exterior de la estructura (400) de soporte de anclaje incluye un revestimiento lubrificante.
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- 2009-05-13 EP EP09160105.4A patent/EP2119417B2/en active Active
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ATE554731T1 (de) | 2012-05-15 |
EP2119417B2 (en) | 2020-04-29 |
EP2119417A3 (en) | 2010-03-10 |
EP2119417B1 (en) | 2012-04-25 |
EP2119417A2 (en) | 2009-11-18 |
US8840661B2 (en) | 2014-09-23 |
US20090287296A1 (en) | 2009-11-19 |
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