ES2313954T3 - Dispositivo para la fijacion y anclaje de protesis de valvulas cardiacas. - Google Patents

Dispositivo para la fijacion y anclaje de protesis de valvulas cardiacas. Download PDF

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Publication number
ES2313954T3
ES2313954T3 ES01929231T ES01929231T ES2313954T3 ES 2313954 T3 ES2313954 T3 ES 2313954T3 ES 01929231 T ES01929231 T ES 01929231T ES 01929231 T ES01929231 T ES 01929231T ES 2313954 T3 ES2313954 T3 ES 2313954T3
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Spain
Prior art keywords
stirrup
stirrups
curved
solid joints
distal
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Expired - Lifetime
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English (en)
Inventor
Carsten Weber
Thomas Peschel
Christoph Damm
Hans-Reiner Figulla
Markus Ferrari
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JenaValve Technology Inc
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JenaValve Technology Inc
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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
    • A61F2/02—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
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/90—Stent for heart valve

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
  • Undergarments, Swaddling Clothes, Handkerchiefs Or Underwear Materials (AREA)
  • Surgical Instruments (AREA)
  • External Artificial Organs (AREA)
  • Control Of Throttle Valves Provided In The Intake System Or In The Exhaust System (AREA)

Abstract

Dispositivo para la fijación y el anclaje de prótesis de válvula cardiaca, formado por elementos en forma de alambre y realizados radialmente simétricos, caracterizado porque en el dispositivo para la fijación y soporte de una prótesis de válvula cardiaca hay respectivamente parejas iguales con un primer estribo (4) curvado y dispuesto distalmente y un estribo (3) curvado en sentido opuesto, unidos entre sí en disposición decalada respectivamente 120º, mediante articulaciones sólidas (7), cumpliendo las articulaciones sólidas (7) la función de cojinetes de giro.

Description

Dispositivo para la fijación y anclaje de prótesis de válvulas cardiacas.
La invención se refiere a un dispositivo para la fijación y anclaje de prótesis de válvulas cardiacas, formado esencialmente por elementos en forma de alambre unidos entre sí. En estado plegado se puede introducir por la aorta de modo mínimamente invasivo, y después de desplegarse se puede anclar en la pared de la aorta, de modo que la prótesis de válvula cardiaca implantada y fijada puede asumir la función de la válvula cardiaca propia del cuerpo.
Hasta la fecha no se ha conseguido suficientemente proponer una solución mediante la cual se pudiera garantizar no sólo un sellado seguro con respecto a la pared de la aorta sino también una fijación segura. Al mismo tiempo es preciso que un dispositivo de esta clase o un soporte de anclaje (stent) de este tipo se ha de poder plegar a un tamaño suficientemente pequeño para desplegarlo después en el lugar del implante. Pero en las soluciones conocidas no se logra un suficiente aumento con la correspondiente fuerza de tensado que pueda garantizar la sujeción. Tampoco cumplen los requisitos las propuestas en las que se trata de emplear un metal con memoria de forma (Memorymetal), a pesar de que en estos metales se produce una dilatación cuando alcanzan o rebasan una temperatura de transición.
Tampoco la solución descrita en el documento
US 5.411.552 puede cumplir los requisitos, ya que se ha de emplear una formación relativamente inestable.
En el documento US 5.855.601 también se describe una prótesis de válvula cardiaca realizada como stent relativamente estable.
El documento US 3.755.823 da a conocer un stent flexible conforme al preámbulo de la reivindica-
ción 1.
Otro problema que hasta la fecha sólo ha sido resuelto de modo insatisfactorio es la fijación de modo seguro de una prótesis de válvula cardiaca artificial o biológica. Por lo general se cosen con gran trabajo las prótesis a un stent. Esto consume mucho tiempo y ha de realizarse con gran cuidado para evitar daños.
Dado que las prótesis de válvula cardiaca implantadas han de mantener su capacidad de funcionamiento a lo largo de periodos de tiempo largos, la realización constructiva también juega un papel esencial, ya que en caso contrario pueden llegar a producirse después del implante daños y faltas de estanqueidad que pueden dar lugar en el paciente a situaciones que amenacen su vida.
Por lo tanto el objetivo de la invención es el de proponer un dispositivo para la fijación y anclaje de prótesis de válvulas cardiacas que se pueda plegar a una dimensión suficientemente pequeña para realizar un implante de carácter invasivo mínimo a través de la aorta y se pueda desplegar en el lugar del implante, estando garantizada una sujeción segura y un sellado seguro respecto a la pared de la aorta.
De acuerdo con la invención se resuelve este objetivo con un dispositivo según la reivindicación 1.
Otras formas de realización ventajosas y perfeccionamientos de la invención se pueden conseguir con las características citadas en las reivindicaciones subordinadas.
Los elementos esenciales de la solución conforme a la invención son respectivamente tres parejas iguales de estribos, que están unidos entre sí en una disposición decalada respectivamente 120º. Los dos estribos de una pareja están doblados con una curvatura opuesta entre sí y unidos mediante articulaciones sólidas. Las articulaciones sólidas cumplen al mismo tiempo la función de cojinetes de giro alrededor de los cuales pueden girar los estribos de una pareja, de modo semejante a un balancín. Si sobre uno de los estribos se ejerce una fuerza de presión, por ejemplo por peristálsis de la aorta, se gira este estribo correspondientemente en el mismo sentido alrededor del eje de giro en la articulación sólida. Al mismo tiempo el otro estribo respectivo de la pareja se gira en sentido opuesto a aquél. En consecuencia se oprime entonces siempre uno de los dos estribos contra la pared de la aorta, lo que aumenta el sellado y la sujeción.
Es conveniente dimensionar los estribos de una pareja de tal modo que se cumplan unas condiciones de palanca lo más parecidas con relación a las articulaciones sólidas que forman los cojinetes de giro, es decir que se formen unos brazos de palanca de igual longitud o al menos de aproximadamente igual longitud.
También son ventajosas las separaciones relativamente grandes entre las articulaciones sólidas, dadas por la disposición a 120º de las parejas de estribos, así como las grandes zonas de superficie cubiertas por los estribos.
Los estribos distales no solamente sirven para la fijación de la prótesis de la válvula cardiaca, sino también asumen una función de soporte.
Mediante otro estribo dispuesto en dirección distal y curvado se pueden mejorar aún más las ventajas citadas.
Para ello, el segundo estribo distal está realizado en su zona distal con una curvatura semejante a la del primer estribo distal. Estos dos estribos están realizados y conformados parcialmente de tal modo que transcurran uno junto al otro y quede entre ellos un intersticio. Pueden estar unidos entre sí en el mismo punto en el que están situadas también las articulaciones sólidas, como unión con el estribo curvado en dirección proximal. Los intersticios formados están por lo tanto abiertos en dirección distal, y en el intersticio se pueden introducir y sujetar partes de la prótesis de la válvula cardiaca.
Al menos una parte de un estribo distal está recogida en sentido proximal y llevada hasta un punto de inflexión en el cual se reúnen estribos contiguos. En dos estribos dispuestos distalmente esto sucede con el respectivo estribo distalmente exterior.
Para dar rigidez y para tener otra posibilidad de fijación de la prótesis de la válvula cardiaca se puede emplear un estribo curvado de forma angular, también recogido proximalmente, cuyas partes curvadas están dispuestas entre estribos contiguos respectivos y realizados siguiendo en parte la curvatura respectiva. Estos estribos están fijados con sus respectivos extremos distales en el un estribo distal exterior o en el respectivo estribo distal exterior. También aquí la fijación forma respectivamente una articulación sólida. Pero éstas deberían estar dispuestas con separación respecto a las otras articulaciones que unen entre sí los estribos de una pareja.
Estando el dispositivo implantado y extendido, se pueden introducir, sujetar y soportar allí las bolsas de una prótesis de válvula cardiaca.
La estructura de estribos del dispositivo conforme a la invención soporta una prótesis de válvula cardiaca en gran superficie y por lo tanto de modo cuidadoso. Además se puede fijar con un trabajo relativamente reducido, por ejemplo cosiendo.
La solución constructiva permite una fijación segura y la estanqueidad necesaria en o frente a la pared de la aorta. Para el sellado y una carga reducida para la prótesis de la válvula cardiaca, resulta favorable también el apriete de la prótesis de la válvula cardiaca desde el interior mediante los estribos.
El dispositivo objeto de la invención se puede implantar con un catéter de balón y desplegar en el lugar del implante. Convenientemente se emplea para el dispositivo también un metal con memoria de forma con una temperatura de transición adecuada, con el cual se puede conseguir adicionalmente una dilatación. Para esto se puede utilizar una aleación que contenga níquel y titanio que puede obtenerse bajo la designación "Nitinol".
La parte del dispositivo que soporta y sujeta la prótesis de la válvula cardiaca se puede implantar además por separado de un cuerpo de soporte, del que se tratará todavía más adelante al describir un ejemplo de realización, sin que se reduzcan las propiedades ventajosas. La implantación de esta parte compuesta esencialmente por los tres segmentos que llevan fijados en ellos la prótesis de la válvula cardiaca puede realizarse entonces de modo operativo de forma convencional.
A continuación se trata de explicar la invención con mayor detalle mediante un ejemplo de realización.
En el dibujo puede verse:
Figura 1 un desarrollo de un ejemplo de un dispositivo conforme a la invención.
En la Figura 1 está representado un desarrollo de un ejemplo de un dispositivo conforme a la invención. El dispositivo está realizado radialmente simétrico, utilizándose tres partes iguales en una disposición a 120º.
En cada parte se emplea una estructura de estribos como soporte y para la fijación de una prótesis de válvula cardiaca artificial o biológica.
En este ejemplo se emplean dos estribos 4 y 5, situados distalmente en el exterior, pudiendo eventualmente renunciarse al estribo exterior 5.
El estribo doblado y curvado 4 está unido a otro estribo 3 curvado en sentido opuesto. Las uniones de ambos lados forman articulaciones sólidas 7 que al mismo tiempo asumen la función de cojinetes de giro para los estribos 3 y 4 que representan las dos palancas, tal como ya se ha explicado en la parte general de la descripción.
El segundo estribo 3, doblado hacia el exterior y dispuesto distalmente aumenta la estabilidad y ofrece una posibilidad adicional de soporte y fijación para la prótesis de la válvula cardiaca. Para ello los dos estribos distales exteriores 4 y 5 también están unidos entre sí, pudiendo efectuarse la unión en el mismo lugar en el que están dispuestas también las articulaciones sólidas 7.
Entre los dos estribos 4 y 5 existen desde la dirección distal unos intersticios abiertos, en los cuales se pueden introducir partes de la prótesis de la válvula cardiaca, fijándola allí.
El estribo 5 que aquí está en la parte exterior, está retirado en dirección proximal más hacia el interior, y unido por su extremo con sendos puentes de soporte 8. En este ejemplo, los puentes de soporte 8 están orientados paralelos al eje longitudinal del dispositivo, y junto con unos puentes transversales en forma de diente de sierra, o rombo o meandro forman un cuerpo de soporte que en estado desplegado asienta contra la pared de la aorta. Para el agarre puede haber o pueden estar formadas unas puntas adicionales 9 en los puentes de soporte 8 y/o en los puentes transversales, que se enganchan en la pared de la aorta.
La disposición y longitud de los puentes de soporte 8 y la correspondiente gran separación hasta la prótesis de la válvula cardiaca fijada en la zona de los estribos 3, 4 y 5 permite posicionar la prótesis de válvula cardiaca sin tener que cerrar o cubrir los vasos coronarios.
En el ejemplo aquí mostrado existen entre los distintos segmentos empleados en la disposición a 120º, además unos estribos 2 recogidos de modo proximal, que están unidos a los estribos distales exteriores 5. También aquí las uniones forman articulaciones sólidas 6, pero que a ser posible deberían estar dispuestas distanciadas de las articulaciones sólidas 7. De este modo se pueden utilizar dos palancas por segmento y con una tal disposición doble reflejada en realizar unas fuerzas aproximadamente dobles para fijar el dispositivo.
En estado implantado desplegado, se pueden volver a introducir entre las partes 1 de los estribos 5 y los estribos 2 partes de la prótesis de la válvula cardiaca de modo alternativo, así soportadas y fijadas en ellos.
El número de estribos empleados se puede incrementar aún más para mejorar la sujeción y reducir más la carga de la prótesis de la válvula cardiaca.

Claims (9)

1. Dispositivo para la fijación y el anclaje de prótesis de válvula cardiaca, formado por elementos en forma de alambre y realizados radialmente simétricos, caracterizado porque en el dispositivo para la fijación y soporte de una prótesis de válvula cardiaca hay respectivamente parejas iguales con un primer estribo (4) curvado y dispuesto distalmente y un estribo (3) curvado en sentido opuesto, unidos entre sí en disposición decalada respectivamente 120º, mediante articulaciones sólidas (7), cumpliendo las articulaciones sólidas (7) la función de cojinetes de giro.
2. Dispositivo según la reivindicación 1, caracterizado porque los dos estribos (3, 4) curvados en sentido opuesto entre sí forman unos brazos de palanca de igual longitud con respecto a las articulaciones sólidas (7).
3. Dispositivo según la reivindicación 1 ó 2, caracterizado porque la prótesis de válvula cardiaca va fijada en el primer estribo (4) y/o en un segundo estribo distal (5).
4. Dispositivo según una de las reivindicaciones 1 a 3, caracterizado porque el primer y segundo estribo distal (4, 5) están curvados parcialmente en el mismo sentido y transcurren paralelos entre sí, de modo que entre ellos se forman intersticios para introducir partes de la prótesis de la válvula cardiaca.
5. Dispositivo según una de las reivindicaciones 1 a 4, caracterizado porque en el segundo estribo distal hay unas partes (1) recogidas en sentido proximal, en las cuales van fijados otros estribos (2) con articulaciones sólidas (6).
6. Dispositivo según una de las reivindicaciones 1 a 5, caracterizado porque las articulaciones sólidas (6) y (7) están dispuestas distanciadas entre
sí.
7. Dispositivo según una de las reivindicaciones 1 a 6, caracterizado porque los extremos proximales del primer estribo (4) o de la parte (1) del segundo estribo (5) están unidos mediante puentes de soporte (8) orientados paralelos al eje longitudinal, que en combinación con una estructura de alambre en forma de diente de sierra, de rombos o de meandros forman un cuerpo de soporte desplegable.
8. Dispositivo según una de las reivindicaciones 1 a 7, caracterizado porque en el cuerpo de soporte están formadas unas puntas (9) para anclaje en la pared de la aorta.
9. Dispositivo según una de las reivindicaciones 1 a 8, caracterizado porque todas las partes (1 a 9) están formadas de un metal con memoria de forma.
ES01929231T 2000-02-28 2001-02-28 Dispositivo para la fijacion y anclaje de protesis de valvulas cardiacas. Expired - Lifetime ES2313954T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10010074A DE10010074B4 (de) 2000-02-28 2000-02-28 Vorrichtung zur Befestigung und Verankerung von Herzklappenprothesen
DE10010074 2000-02-28

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ES2313954T3 true ES2313954T3 (es) 2009-03-16

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ES01929231T Expired - Lifetime ES2313954T3 (es) 2000-02-28 2001-02-28 Dispositivo para la fijacion y anclaje de protesis de valvulas cardiacas.
ES08163041T Expired - Lifetime ES2421438T3 (es) 2000-02-28 2001-02-28 Dispositivo para la fijación y anclaje de prótesis de válvulas cardiacas

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US (2) US7198646B2 (es)
EP (2) EP1994913B1 (es)
JP (2) JP4295460B2 (es)
AT (1) ATE410979T1 (es)
CY (1) CY1108696T1 (es)
DE (2) DE10010074B4 (es)
DK (2) DK1994913T3 (es)
ES (2) ES2313954T3 (es)
PT (2) PT1259195E (es)
WO (1) WO2001062189A1 (es)

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US11357624B2 (en) 2007-04-13 2022-06-14 Jenavalve Technology, Inc. Medical device for treating a heart valve insufficiency
US11589981B2 (en) 2010-05-25 2023-02-28 Jenavalve Technology, Inc. Prosthetic heart valve and transcatheter delivered endoprosthesis comprising a prosthetic heart valve and a stent
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FR2826863B1 (fr) 2001-07-04 2003-09-26 Jacques Seguin Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel
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USRE45130E1 (en) 2014-09-09
DE10010074B4 (de) 2005-04-14
ATE410979T1 (de) 2008-10-15
PT1259195E (pt) 2008-12-17
EP1259195B1 (de) 2008-10-15
EP1259195A1 (de) 2002-11-27
EP1994913B1 (de) 2013-05-15
DE10010074A1 (de) 2001-10-18
JP2003523262A (ja) 2003-08-05
US7198646B2 (en) 2007-04-03
CY1108696T1 (el) 2014-04-09
DK1994913T3 (da) 2013-07-22
DK1259195T3 (da) 2009-02-09
US20030149478A1 (en) 2003-08-07
PT1994913E (pt) 2013-08-22
EP1994913A2 (de) 2008-11-26
JP4295460B2 (ja) 2009-07-15
WO2001062189A1 (de) 2001-08-30
ES2421438T3 (es) 2013-09-02
EP1994913A3 (de) 2008-12-03
JP2009061293A (ja) 2009-03-26
DE50114421D1 (de) 2008-11-27

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