ES2335652T3 - Unidad que permite ajustar una valvula protesica en un conducto corporal. - Google Patents

Unidad que permite ajustar una valvula protesica en un conducto corporal. Download PDF

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ES2335652T3
ES2335652T3 ES02791513T ES02791513T ES2335652T3 ES 2335652 T3 ES2335652 T3 ES 2335652T3 ES 02791513 T ES02791513 T ES 02791513T ES 02791513 T ES02791513 T ES 02791513T ES 2335652 T3 ES2335652 T3 ES 2335652T3
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unit
valve
tubular part
support
tubular
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Inc. Corevalve
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Medtronic CoreValve LLC
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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis, e.g. in a single operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis, e.g. in a single operation
    • A61B17/1155—Circular staplers comprising a plurality of staples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00535—Surgical instruments, devices or methods pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods pneumatically or hydraulically operated inflatable
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2230/0078—Quadric-shaped hyperboloidal

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mechanical Engineering (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)
  • Feeding And Controlling Fuel (AREA)
  • External Artificial Organs (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Endoscopes (AREA)

Abstract

Unidad (1) que permite ajustar una válvula protésica (3) en un conducto corporal, que comprende la válvula protésica (3) a implantar y un soporte (2) que recibe esta válvula (3), conformándose la válvula (3) y el soporte (2) de manera que pueden adoptar una posición de contracción radial, que permite su inserción en el conducto corporal a equipar usando medios (10) de inserción/extensión, y una posición de extensión radial, en la que el soporte (2) se inmoviliza con respecto a la pared del conducto corporal a equipar; comprendiendo el soporte (2): - al menos una parte tubular (4) de un material ligeramente elástico en dirección circunferencial, que presenta, en su posición de extensión, una dimensión en la dirección circunferencial que corresponde aproximadamente a la dimensión en la dirección circunferencial de la localización (101, 102) del conducto corporal con respecto al cual debe implantarse esta parte tubular (4); - medios (6) de fijación de esta parte tubular (4) a la pared del conducto corporal, caracterizándose la unidad por que el soporte comprende: - una pluralidad de elementos de refuerzo alargados (5), dispuestos sobre la circunferencia de dicha parte tubular (4) y unidos a esta parte tubular (4) de manera independiente entre sí; estando unida la válvula (3) al menos parcialmente a esos elementos de refuerzo alargados (5), particularmente a nivel de las comisuras (3a) de sus válvulas y formando esos elementos de refuerzo alargados (5) conjuntamente, en posición extendida, una estructura que tiene un diámetro predeterminado que garantiza la extensión adecuada de esta válvula (3).

Description

Unidad que permite ajustar una válvula protésica en un conducto corporal.
La presente invención se refiere a una unidad que permite ajustar una válvula protésica en un conducto corporal, particularmente una válvula cardíaca y en particular una válvula aórtica.
Cada uno de los documentos WO 91/17720, WO 98/29057 y EP 1 057 460 describe una unidad de este tipo que comprende:
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la válvula protésica a implantar;
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un refuerzo radialmente expansible, es decir "stent" (endoprótesis vascular), adecuado, en estado extendido, para apoyarse contra la pared del conducto corporal a equipar, permitiendo esta toma de apoyo inmovilizar ese stent con respecto a esta pared; y
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medios de fijación de la válvula al stent.
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El ajuste del stent permite de esta manera el montaje de la válvula en el conducto corporal, eliminando la necesidad de acceder desde el exterior y por tanto una intervención quirúrgica directa.
Esta técnica sin embargo tiene como inconvenientes principales inducir un riesgo de deterioro de la válvula por el globo utilizado para realizar la expansión del stent, y limitar la fuerza de expansión que es posible infundir al stent. Esta limitación tiene una repercusión sobre el anclaje del stent, haciendo posible un desplazamiento de dicha unidad. Esta limitación también tiene una repercusión sobre el cierre hermético del stent a nivel del anillo valvular, afectado particularmente cuando zonas calcificadas confieren al anillo valvular una forma irregular y/o una determinada rigidez.
La expansión de un globo también puede producir daños al conducto corporal, particularmente cuando éste es un vaso sanguíneo.
La utilización de un stent auto extensible apenas es posible, un stent de este tipo no tiene una fuerza radial de apoyo a la vez que permite el suficiente anclaje a la unidad.
Además, el conducto corporal a equipar puede, en el lugar del implante, no presentar una sección transversal perfectamente circular, particularmente cuando se conserva la válvula original y que esta válvula, o el anillo valvular, comprenda zonas calcificadas. Cualquiera que sea el grado de expansión del stent, la forma circular de este stent puede no adaptarse a la anatomía específica del lugar del implante. Puede producirse un defecto de hermetismo de la válvula implantada.
Además, el stent presenta una rigidez determinada, que induce una rigidez al catéter del implante. Esta rigidez puede dificultar el avance de ese catéter hasta el lugar del implante.
Otro inconveniente de la técnica anterior es el de unir directamente las comisuras de las válvulas al stent. Esto hace que una expansión del stent, y por tanto de la válvula, diferente a la prevista pueda generar una mala coadaptación de las válvulas y por tanto un funcionamiento defectuoso de la válvula. El stent debe por consiguiente realizar una expansión predeterminada que impida, o dificulte, la adaptación de este stent a la variabilidad anatómica.
La técnica anterior también presenta el inconveniente, en el caso de implante de una válvula aórtica, de inducir un riesgo de taponamiento de las aberturas coronarias.
La presente invención pretende remediar estos diferentes inconvenientes.
La unidad a la que se refiere comprende, como se sabe, la válvula protésica a implantar y un soporte que recibe esta válvula, conformándose la válvula y el soporte de manera que pueden adoptar una posición de contracción radial, que permite su inserción en el conducto corporal a equipar usando medios inserción/extensión, y una posición de extensión radial, en la que se inmoviliza el soporte con respecto a la pared del conducto corporal a equipar. El documento US-A-6 042 607 describe una unidad que se corresponde con el preámbulo de la reivindicación 1.
De acuerdo con la invención, el soporte comprende:
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al menos una parte tubular de un material flexible ligeramente elástico en la dirección circunferencial, que presenta, en su posición de extensión, una dimensión en la dirección circunferencial que corresponde aproximadamente a la dimensión en la dirección circunferencial de la localización del conducto corporal con respecto al cual debe implantarse esta parte tubular;
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medios para la fijación de esta parte tubular en la pared del conducto corporal y
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una pluralidad de elementos de refuerzo alargados, dispuestos sobre la circunferencia de dicha parte tubular y unidos a esta parte tubular de manera independiente entre sí; la válvula está unida al menos parcialmente a estos elementos de refuerzo alargados, particularmente al nivel de las comisuras de esas válvulas y esos elementos de refuerzo alargados forman conjuntamente, en posición extendida, una estructura que tiene un diámetro predeterminado que garantiza la extensión adecuada de esta válvula.
El soporte de acuerdo con la invención no está formado de esta manera por un stent expansible que se apoya rozando contra la pared del conducto corporal a equipar, sino que está formado (i) por al menos una parte tubular flexible ligeramente elástica circunferencialmente, prevista de medios de fijación en la pared del conducto corporal, y (ii) por una estructura de montaje de la válvula, extendida por esta o estas partes tubulares.
Éstas últimas realizan por si solas una extensión activa, realizada particularmente por medio de uno o varios globos hinchables, a nivel de sus zonas provistas de dichos medios de fijación; las válvulas de la válvula se unen a dichos elementos de refuerzo alargados y por tanto se sitúan sobre una parte del soporte que no va a requerir medios de extensión, de manera que se elimina el riesgo al deterioro de estas válvulas por estos medios de extensión.
La extensión de la o de las partes tubulares no requiere una fuerza radial tan considerable como la necesaria para la extensión de un stent, y la ligera flexibilidad, de ésta o estas partes tubulares más allá de su posición de extensión permite suprimir el riesgo a deteriorar el conducto corporal que se produce al utilizar los globos hinchables.
La estructura flexible de la o de las partes tubulares las permite además ajustarse perfectamente a la anatomía específica del lugar del implante, particularmente cuando éste no es circular en sección transversal debido a la presencia de zonas calcificadas.
El soporte tiene una rigidez longitudinal global claramente menor que la de un stent, lo que facilita notablemente el avance del catéter del implante hasta el lugar del implante.
Las comisuras de las válvulas no están unidas a una zona extensible y la estructura formada por dichos elementos de refuerzo alargados garantizan la extensión adecuada de estas válvulas.
La válvula puede fabricarse de un tejido biológico o de un material sintético como por ejemplo un polímero. Puede presentar un anillo de base que permite su unión hermética, particularmente por sutura, a dicha parte tubular o a una de dichas partes tubulares.
Dicha parte tubular, o una pared periférica que comprende la válvula, puede presentar aberturas laterales de manera que permite un flujo natural sanguíneo hacia las aberturas coronarias, sin riesgo de estancamiento.
Preferentemente, dicha o dichas partes tubulares presentan al menos una cámara periférica hinchable, que puede hincharse para formar una articulación que asegura el hermetismo entre esta parte tubular y la pared del conducto corporal a equipar.
La zona proximal de la parte tubular o de la porción tubular proximal en caso de una pluralidad de partes tubulares, puede presentar una forma troncocónica adaptada para apoyarse contra la pared del ventrículo.
La o las partes tubulares pueden fabricarse a partir de un material biológico o sintético, particularmente un polímero o un tejido de fibras conocido como "dacron".
Dichos medios de fijación están preferentemente formados por grapas de anclaje que presentan varillas de anclaje, insertándose estas varillas de anclaje en la pared del conducto corporal a equipar al final de la extensión de ésta o estas partes tubulares.
Éstas grapas pueden ser plásticamente deformables; los medios pueden estar provistos para extender las varillas de anclaje de estas grapas de una manera no radial, particularmente en una orientación oblicua o de acuerdo con una trayectoria curva, para reforzar la resistencia del anclaje obtenido.
Al menos una de estas grapas puede ser de un material con memoria de forma tal como de aleación de níquel y de titanio conocido con la denominación "NITINOL". Una grapa de este tipo puede entonces adoptar antes del implante una configuración de inserción, en la que sus varillas de anclaje se orientan sensiblemente de manera radial con respecto a la parte tubular para poder insertarse en la pared del conducto, y una configuración de anclaje, en la que estas mismas varillas de anclaje se orientan de manera no radial y/o se curvan para garantizar el anclaje de las grapas en la pared del conducto corporal a equipar.
Los medios de fijación también pueden comprender un adhesivo biológico, que puede estar contenido en las vesículas rompibles situadas sobre la superficie radialmente externa de la o de las partes tubulares.
Estas vesículas se rompen durante su aplastamiento entre la o las partes tubulares y la pared del conducto corporal y permiten de este modo liberar el adhesivo.
Cada elemento de refuerzo alargado presenta ventajosamente una forma curva y se dispone con su lado convexo girado radialmente hacia el interior del soporte, de tal manera que este soporte presenta, a nivel de su zona media, un diámetro inferior con respecto al que presenta a nivel de sus extremos axiales.
Este diámetro inferior permite eliminar cualquier riesgo de recubrimiento de las aberturas coronarias.
De acuerdo con una forma de realización preferida de la invención, el soporte comprende:
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dos partes tubulares tales como las descritas anteriormente, y
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una de los extremos de dichos elementos de refuerzo alargados está unido a una de esas partes tubulares mientras que el otro extremo de estos elementos de refuerzo alargado está unido a la otra parte tubular.
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La extensión de estas dos partes tubulares garantiza una perfecta extensión de los elementos de refuerzo alargados.
De acuerdo con otra forma de realización posible de la invención, el soporte comprende una parte tubular única que se extiende sobre la unidad del soporte, en la pared a la que se unen dichos elementos de refuerzo alargados.
Esta parte tubular única puede presentar las aberturas laterales mencionadas anteriormente con respecto a las aberturas coronarias.
De acuerdo aún con otra forma de realización posible de la invención, el soporte comprende una parte tubular única, de la que, dichos elementos de refuerzo alargados, sobresalen sobre un extremo axial de esta parte tubular.
Este soporte puede permitir particularmente el implante de una válvula mitral.
Para su buena comprensión, la invención se describe de nuevo a continuación con referencia a los dibujos esquemáticos adjuntos que representan, a modo de ejemplo no limitativo, una forma de realización preferida de la unidad a la que se refiere la invención.
La figura 1 es una vista lateral con sección parcial, en estado extendido y antes del implante, en el caso de un implante de una válvula aórtica;
la figura 2 es una vista lateral durante la colocación en una aorta y antes de la extensión, que se encuentra situada sobre un instrumento que permite su colocación y su extensión;
la figura 3 es una vista parcial, a escala aumentada, antes del anclaje a la pared aórtica;
la figura 4 es una vista similar a la figura 2, durante la extensión;
la figura 5 es una vista similar a la figura 3 después del anclaje a la pared aórtica;
la figura 6 es una vista similar a la figura 1 después del implante, habiéndose retirado dicho instrumento de colocación y de extensión;
las figuras 7 y 8 son vistas de dicha unidad similares a la figura 6 de acuerdo con dos variantes de realización, representándose esquemáticamente en la figura 8 dicho instrumento de colocación y de extensión;
las figuras 9A, 10A, 11A, 12A, 13A y 14A son vistas en sección de una paleta que comprende dicha unidad y de una grapa que incluye esta paleta, antes de llegar a graparse en posición de anclaje;
las figuras 9B, 10B, 11B, 12B, 13B y 14B son vistas que corresponden respectivamente a las figuras 9A, 10A, 11A, 12A, 13A y 14A después de llegar a graparse en posición de anclaje;
la figura 13C es una vista en sección de acuerdo con la línea XIIIC-XIIIC de la figura 13B;
las figuras 15 y 16 son vistas en perspectiva de otras variantes de realización de una grapa;
la figura 17 es una vista lateral de otra variante de realización de una grapa;
la figura 18 es una vista en sección de otra forma de realización de dicho instrumento de colocación y extensión, durante la colocación de dicha unidad;
la figura 19 es una vista de este instrumento similar a la figura 18 durante el implante de esta unidad;
la figura 20 es una vista en sección de este instrumento de acuerdo con la línea XX-XX de la figura 19;
las figuras 21 y 22 son vistas en sección longitudinal de otras tres formas de realización de este mismo instrumento, cuando está colocado en una aorta; mostrando también la figura 21 dicha unidad durante el implante, y
la figura 23 es una vista de dicha unidad, en el caso de implante de una válvula mitral.
La figura 1 representa una unidad 1 que permite ajustar una válvula aórtica protésica en una aorta.
Esta unidad 1 comprende un soporte 2 sobre el cual se monta esta válvula aórtica protésica 3.
El soporte 2 comprende dos partes tubulares de extremos 4 y una serie de elementos de refuerzo alargados 5.
Las partes tubulares 4 son de un material flexible ligeramente elástico en la dirección circunferencial de esas partes tubulares 4. Pueden fabricarse particularmente a partir de un polímero o de un tejido de fibras conocido como "dacron", o de un tejido biológico como el pericardio.
El diámetro de esas partes tubulares 4 corresponden aproximadamente al diámetro de las localizaciones de la aorta con respecto a las cuales dichas partes tubulares 4 están destinadas a implantarse, es decir, como se muestra en las figuras 2 a 6, respectivamente el anillo valvular original 101 y la pared 102 de la aorta se extienden más allá de las aberturas coronarias 103.
Cada elemento de refuerzo alargado 5 se fabrica a partir de un material relativamente rígido, particularmente de un material metálico. Presenta una parte central alargada curva 5a y dos paletas de extremos 5b, por las que se une a las respectivas partes tubulares 4.
Como se muestra en la figura 1, estos elementos 5 se distribuyen de manera regular sobre la periferia de las partes tubulares 4 y se disponen con su lado convexo girado radialmente hacia el interior del soporte 2. Este último presenta por tanto, a nivel de su zona media, un diámetro inferior al que presenta a nivel de sus extremos axiales.
Cada paleta 5b está integrada en la parte tubular 4 correspondiente y está fijada a ésta particularmente por suturas. Comprende uno o varios huecos atravesados dispuestos radialmente, en particular dos huecos en el ejemplo representado, en los que se introducen las varillas laterales de anclaje de una grapa 6.
Como se muestra en las figuras 1 y 3, estas varillas laterales se sitúan, antes del implante, por detrás de los orificios radialmente exteriores de estos huecos, de manera que la grapa 6 no sobresale más allá de la superficie radialmente exterior de la parte tubular 4 sino que sobresale radialmente hacia el interior de esta parte tubular 4. Estos huecos se ajustan a dichas varillas laterales de manera que la grapa 6 se mantiene en esos huecos por rozamiento. Estas varillas pueden no obstante deslizarse en esos huecos hacia una posición de anclaje representada en las figuras 5 y 6, cuando se coloca un globo hinchable contra la varilla mediana de la grapa 6.
La válvula 3 no forma parte en sí misma de la invención y no se ha detallado particularmente. Puede fabricarse a partir de un tejido biológico o de un material sintético, particularmente un polímero, y presenta un anillo de base unido a la parte tubular 4 proximal particularmente por sutura y válvulas cuyas comisuras 3a se unen a las partes 5a adyacentes de los elementos 5.
La unión del anillo de base a la parte 4 proximal garantiza el hermetismo de la válvula 3 entre este anillo y esta parte tubular, y la unión de las comisuras 3a a los elementos 5 permite la extensión de las válvulas cuando se realiza la extensión del soporte 2.
El instrumento 10 de posicionamiento y de extensión de la unidad 1 comprende, como se representa en la figura 2, un catéter 11 de flujo sanguíneo durante el implante de la unidad 1, tres globos 12, 13, 14 y una envoltura 9 de sujeción de las partes 4 y de los elementos 5 en una posición de contracción.
El catéter 11 comprende una abertura distal 11a de flujo sanguíneo más allá de la unidad 1 durante el implante. Eventualmente puede comprender una bomba que facilita este flujo.
El globo proximal 12 es troncocónico y se dimensiona para apoyarse contra la pared ensanchada 104 del ventrículo cuando se hincha. Permite de esta manera, a consecuencia de su apoyo contra esta pared 104, posicionar con precisión el instrumento 10 y la unidad 1 con respecto al lugar del implante, no obstante los latidos del corazón desbloquean el paso sanguíneo para canalizarse en el interior del catéter 11.
El globo 13 se extiende con respecto al anillo de base de la válvula 3. Permite la extensión de la parte 4 proximal y de este anillo de base.
El globo distal 14 se extiende en cuanto al mismo con respecto a la parte 4 distal, lo que permite la extensión.
La envoltura 9 se desliza sobre el catéter 11 y permite, cuando se retira, liberar la unidad 1. Como se muestra en la figura 4, el globo 13 se hincha aunque la envoltura 9 recubre aún la parte 4 distal. El hinchamiento del globo 13 se realiza hasta colocar la parte 4 contra el anillo 101 después apoyarse contra las varillas medianas de las grapas 6 para realizar el deslizamiento de las grapas 6 en los huecos de las paletas 5b e insertar de esta manera las varillas laterales de esas grapas 6 en este anillo 101.
Una vez que se ha realizado el anclaje de la parte 4 proximal, la envoltura 9 se retrae para liberar la parte 4 distal, que está extendida y anclada por medio del globo 14, de la misma manera que se indicado anteriormente.
La extensión de las partes tubulares 4 produce la extensión de los elementos 5 y por tanto de la válvula 3.
La estructura flexible de las partes 4 permite a estas últimas ajustarse a la anatomía específica del lugar del implante, particularmente cuando se conserva la válvula original y/o cuando esta válvula o el anillo 101 presentan zonas calcificadas.
Los elementos 5 permiten garantizar la extensión adecuada de las válvulas cualquiera que sea la forma de las partes tubulares 4 después del implante, y los espacios laterales que delimitan esos elementos 5 entre si permiten un amplio flujo sanguíneo hacia las aberturas coronarias 103.
En cuanto a las grapas 6 permiten, por su número, garantizar una perfecta inmovilización de la unidad 1 en el lugar del implante.
La figura 7 muestra una unidad 1 en la que la válvula 3 presenta una pared periférica 3b. Esta pared 3b está unida a elementos 5 y presenta aberturas laterales 18, dispuestas entre las válvulas, que permiten el flujo sanguíneo hacia las aberturas coronarias 103.
La figura 8 muestra una unidad 1 en la que la zona proximal 4a de la parte tubular proximal 4 presenta, o adopta por deformación elástica, una forma troncocónica adaptada para apoyarse contra la pared 104 del ventrículo. El globo 12 permite la extensión de esta zona 4a.
Las figuras 9A a 17 muestran diferentes variantes posibles en las formas de las paletas 5b y de las grapas 6.
Las figuras 9A a 13C muestran grapas 6 que permiten un anclaje por deformación plástica. En este caso, los huecos de una paleta 5b pueden no orientarse radialmente sino en oblicuo (véase figura 9A) de manera que se realiza una extensión oblicua de las varillas de anclaje de la grapa 6 (véase la figura 9B), reforzando la resistencia del anclaje obtenido; la varilla mediana de la grapa 6 puede presentar una forma no rectilínea, es decir en espiga (véase la figura 10A) u ondulada (véase la figura 11A), para orientar las varillas de anclaje según las direcciones oblicuas cuando los globos 13 y 14 se aplican contra ella (véanse las figuras 10B, 11B); las varillas laterales pueden ser rectilíneas (véanse las figuras 9A a 10B) o curvas (véanse las figuras 11A, 11B).
Al menos una grapa 6 puede ser también de un material de memoria de forma, particularmente de aleación de níquel y de titanio conocido con el nombre "NITINOL". Las varillas de anclaje de esta grapa 6 pueden ser rectilíneas antes del anclaje (véase la figura 12A) y pueden curvarse, por memoria de forma (véase la figura 12B).
La grapa 6 también puede desplazarse axialmente con respecto a la paleta 5b, orientándose con respecto a ésta, para extender dichas varillas de anclaje. Esta orientación puede realizarse particularmente introduciendo una o varias zapatas 6a que comprende en una ranura en "T" dispuesta en la paleta 5b (véase figuras 13A a 13C); pudiendo girar estas varillas de anclaje y desplazarse para apoyarse contra las paredes 15 correspondientes de la paleta 5b (véanse las figuras 13A, 13B) o deformarse (véanse figuras 14A, 14B).
Ese desplazamiento puede realizarse particularmente por medio de un globo de múltiples cámaras, hinchadas sucesivamente para incorporar axialmente las grapas 6 hacia la posición de extensión de sus varillas de anclaje.
Las figuras 15 y 16 muestran que las grapas 6 puede presentar dos varillas medianas perpendiculares y comprender entonces cuatro varillas de anclaje que favorecen un hundimiento perpendicular en la pared. Estas varillas medianas pueden incluir una plaqueta 16 que favorece el apoyo de los globos 13 y 14 contra ellas.
La figura 17 muestra que las grapas 6 pueden presentar forma de arpón. También pueden tener forma de chincheta.
Las figuras 18 a 20 muestran que el globo 14 puede sustituirse por brazos radiales desplegables 21. El instrumento 10 presenta entonces un catéter 11, un globo 23 de extensión de elementos 5 y una envoltura interior 24 unida por su extremo proximal al catéter 11 pero que puede deslizarse con respecto a este último hacia fuera de este extremo. Esta envoltura 24 presenta ranuras longitudinales que individualizan los brazos 21, y su deslizamiento provoca la extensión de esos brazos 21 por deformación elástica de esta envoltura 24.
La figura 21 muestra que el globo 12 puede sustituirse por una estructura 25 de brazos radiales desplegables 26 similares a los descritos en relación a las figuras 18 a 20.
La figura 22 muestra que el globo 12 puede sustituirse por una estructura 35 desplegable a modo de paraguas, comprendiendo esta estructura 35 una serie de "ballenas" 36 de toma de apoyo contra la pared 104.
La figura 23 muestra una unidad 1 cuyo soporte 2 comprende una parte tubular 4 única, de la que sobresalen, sobre un extremo axial de esta parte tubular 4, elementos de refuerzo alargados 5. Estos últimos son rectilíneos y de longitud limitada; permiten, del mismo modo indicado anteriormente, la extensión de la válvula 3.
De este modo, según lo indicado anteriormente, la invención proporciona una unidad que permite ajustar una válvula protésica en un conducto corporal, particularmente una válvula cardíaca y en particular una válvula aórtica, que presenta ventajas determinantes con respecto a las unidades homologas de la técnica anterior.
Ni que decir que la invención no se limita a la forma de realización descrita anteriormente como ejemplo sino que por contra incluye todas las variantes de realización que entran en el ámbito de la protección definida por las reivindicaciones adjuntas en este documento. De esta manera, los elementos 5 pueden presentar una forma rectilínea en reposo y contraerse a nivel de su parte central por un elemento que sujeta su expansión radialmente para proporcionarle una curvatura hacia el interior del conducto corporal; el globo 13 puede sustituirse por brazos radiales desplegables; pueden considerarse otros medios de posicionamiento proximal aparte del globo 12, los brazos 25 o las ballenas 36, el catéter 11 puede comprender una válvula anti-retorno.

Claims (18)

1. Unidad (1) que permite ajustar una válvula protésica (3) en un conducto corporal, que comprende la válvula protésica (3) a implantar y un soporte (2) que recibe esta válvula (3), conformándose la válvula (3) y el soporte (2) de manera que pueden adoptar una posición de contracción radial, que permite su inserción en el conducto corporal a equipar usando medios (10) de inserción/extensión, y una posición de extensión radial, en la que el soporte (2) se inmoviliza con respecto a la pared del conducto corporal a equipar; comprendiendo el soporte (2):
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al menos una parte tubular (4) de un material ligeramente elástico en dirección circunferencial, que presenta, en su posición de extensión, una dimensión en la dirección circunferencial que corresponde aproximadamente a la dimensión en la dirección circunferencial de la localización (101, 102) del conducto corporal con respecto al cual debe implantarse esta parte tubular (4);
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medios (6) de fijación de esta parte tubular (4) a la pared del conducto corporal, caracterizándose la unidad por que el soporte comprende:
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una pluralidad de elementos de refuerzo alargados (5), dispuestos sobre la circunferencia de dicha parte tubular (4) y unidos a esta parte tubular (4) de manera independiente entre sí; estando unida la válvula (3) al menos parcialmente a esos elementos de refuerzo alargados (5), particularmente a nivel de las comisuras (3a) de sus válvulas y formando esos elementos de refuerzo alargados (5) conjuntamente, en posición extendida, una estructura que tiene un diámetro predeterminado que garantiza la extensión adecuada de esta válvula (3).
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2. Unidad (1) de acuerdo con la reivindicación 1, caracterizada por que la válvula (3) presenta un anillo de base que permite su unión hermética, particularmente por sutura, a dicha parte tubular (4) o a una de dichas partes tubulares (4).
3. Unidad (1) de acuerdo con la reivindicación 1 o la reivindicación 2, para implantar una válvula aórtica (3), caracterizada por que dicha parte tubular (4) o una pared periférica (3b) que comprende la válvula (3), presenta aberturas laterales (18) de manera que permite un flujo natural sanguíneo hacia las aberturas coronarias (103) sin riesgo de estancamiento.
4. Unidad (1) de acuerdo con una de las reivindicaciones 1 a 3, caracterizada por que la o dichas partes tubulares presentan al menos una cámara periférica hinchable, que puede hincharse para formar una articulación que garantiza el cierre hermético entre esta parte tubular y la pared del conductor corporal a equipar.
5. Unidad (1) de acuerdo con una de las reivindicaciones 1 a 4 para implantar una válvula aórtica (3), caracterizada por que la zona proximal de dicha parte tubular, o de la parte tubular (4) proximal en caso de una pluralidad de partes tubulares, presenta una forma troncocónica adecuada para apoyarse contra la pared de ventrículo.
6. Unidad (1) de acuerdo con una de las reivindicaciones 1 a 5, caracterizada por que dichos medios de fijación están formados por grapas de anclaje (6) que presentan varillas de anclaje, insertándose estas varillas de anclaje en la pared del conducto corporal a equipar al final de la extensión de esta o estas partes tubulares (4).
7. Unidad (1) de acuerdo con la reivindicación 6, caracterizada por que las grapas (6) son plásticamente deformables y por que los medios (5b, 15) se proporcionan para extender las varillas de anclaje de esas grapas (6) de manera no radial, particularmente en oblicuo o de acuerdo con una trayectoria curva.
8. Unidad (1) de acuerdo con la reivindicación 6, caracterizada por que al menos una grapa (6) es de un material con memoria de forma tal como de aleación de níquel y de titanio conocido como "NITINOL".
9. Unidad (1) de acuerdo con una de las reivindicaciones 1 a 8, caracterizada por que dichos medios de fijación comprenden un adhesivo biológico.
10. Unidad (1) de acuerdo con la reivindicación 9, caracterizada por que el adhesivo se encuentra en el interior de vesículas rompibles situadas sobre la superficie radialmente externa de la parte o partes tubulares.
11. Unidad (1) de acuerdo con una de las reivindicaciones 1 a 10, caracterizada por que cada elemento de refuerzo alargado (5) presenta una forma curva y se dispone con su lado convexo girado radialmente hacia el interior del soporte (2), de manera que este soporte (2) presenta a nivel de su zona media, un diámetro inferior respecto al que presenta a nivel de sus extremos axiales.
12. Unidad (1) de acuerdo con una de las reivindicaciones 1 a 11, caracterizada por que el soporte (2) comprende:
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dos partes tubulares (4) como se han descrito anteriormente, y
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uno de los extremos de dichos elementos de refuerzo alargados (5) está unido a una de esas partes tubulares (4) mientras que el otro extremo de estos elementos de refuerzo alargados (5) está unido a la otra parte tubular (4).
13. Unidad (1) de acuerdo con una de las reivindicaciones 1 a 11, caracterizada por que el soporte comprende una parte tubular única que se extiende sobre la unidad del soporte, a la pared a la que se unen dichos elementos de refuerzo alargados.
14. Unidad de acuerdo con una de las reivindicaciones 1 a 11, caracterizada por que el soporte (2) comprende una parte tubular (4) única, de la cual dichos elementos de refuerzo alargados (5) sobresalen sobre un extremo axial de esta parte tubular (4).
15. Unidad de acuerdo con una de las reivindicaciones 1 a 14, caracterizada por que los elementos de refuerzo alargados presentan una forma rectilínea en reposo y están limitados a nivel de su parte central por un elemento que sujeta su expansión radialmente para proporcionarlos una curva hacia el interior del conducto corporal.
16. Combinación de la unidad (1) de acuerdo con una de las reivindicaciones 12 a 15 y medios (10) de inserción/extensión para ajustar esta unidad (1), caracterizada por que dichos medios de inserción/extensión comprenden un catéter (11) de flujo sanguíneo durante el implante de la unidad (1), al menos un globo (13, 14) para extender al menos una parte tubular (4) y una envoltura (9) para sostener esta parte tubular (4) y elementos de refuerzo alargados (5) en una posición de contracción.
17. Combinación de acuerdo con la reivindicación 16, caracterizada por que dichos medios (10) de inserción/ex-
tensión comprenden un medio de posicionamiento proximal (12, 25, 36), dimensionado para apoyarse contra la pared (104) del ventrículo.
18. Combinación de acuerdo con la reivindicación 16 o la reivindicación 17, caracterizada por que dichos medios (10) de inserción/extensión comprenden una bomba que facilita el flujo sanguíneo más allá de la unidad (1) durante el implante.
ES02791513T 2001-07-31 2002-07-30 Unidad que permite ajustar una valvula protesica en un conducto corporal. Expired - Lifetime ES2335652T3 (es)

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EP1411865A2 (fr) 2004-04-28
EP1411865B1 (fr) 2009-08-26
ATE440568T1 (de) 2009-09-15
DK1411865T3 (da) 2010-01-04
US20050033398A1 (en) 2005-02-10
AU2002334045B2 (en) 2007-11-08
JP4212474B2 (ja) 2009-01-21
FR2828091B1 (fr) 2003-11-21
US7682390B2 (en) 2010-03-23
DE60233503D1 (de) 2009-10-08
WO2003011195A2 (fr) 2003-02-13
WO2003011195A3 (fr) 2004-02-12
CA2456002C (fr) 2010-07-20
JP2004535897A (ja) 2004-12-02
CA2456002A1 (fr) 2003-02-13
FR2828091A1 (fr) 2003-02-07

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