ES2243635T3 - Soporte metalico de vasos degradable "in vivo". - Google Patents

Soporte metalico de vasos degradable "in vivo".

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Publication number
ES2243635T3
ES2243635T3 ES02019905T ES02019905T ES2243635T3 ES 2243635 T3 ES2243635 T3 ES 2243635T3 ES 02019905 T ES02019905 T ES 02019905T ES 02019905 T ES02019905 T ES 02019905T ES 2243635 T3 ES2243635 T3 ES 2243635T3
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magnesium
holder according
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vessel
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Bernd Prof. Dr. Heublein
Gerd Prof. Dr. Hausdorf
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A—HUMAN NECESSITIES
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    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12104—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in an air passage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A—HUMAN NECESSITIES
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    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A—HUMAN NECESSITIES
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    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/866—Material or manufacture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00017—Iron- or Fe-based alloys, e.g. stainless steel

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
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  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Soporte de vasos de una sustancia metálica degradable "in vivo" por corrosión, caracterizado porque la sustancia es una aleación cuya parte constituyente principal es magnesio.

Description

Soporte metálico de vasos degradable "in vivo".
La presente invención se refiere a un soporte hecho de materiales metálicos para su empleo en el cuerpo humano o animal.
Los implantes se conocen fundamentalmente desde hace mucho tiempo. Los primeros implantes se desarrollaron con finalidades ortopédicas, por ejemplo tornillos y clavos para la fijación de roturas óseas. En principio, éstos estaban formados por aleaciones de hierro relativamente sencillas, que bajo condiciones "in vivo" tendían a la corrosión. La corrosión llevaba a que se liberaran directamente junto al hueso metales como iones, lo cual proporcionaba un estímulo indeseado para el crecimiento de tejido óseo. El hueso crecía más fuerte de lo que realmente se deseaba y requería. Por ello, se dañaba el material óseo sano.
Por esta razón se pretende fabricar implantes metálicos fundamentalmente a partir de materiales lo más resistentes posible a la corrosión. En este sentido, se emplean hoy en día fundamentalmente aceros inoxidables resistentes a la corrosión, tántalo y titanio. Estos implantes continúan presentes después de la implantación como cuerpos extraños, y son reconocidos como tales por el organismo. Sólo pueden ser retirados por medio de una segunda operación.
Adicionalmente, los implantes metálicos se conocen en el campo de la cirugía de vasos y de la cardiología, angiología y radiología. Estos implantes comprenden, por ejemplo, soportes endoluminales y de vasos (cánulas intraluminales) para el tratamiento de lesiones. Estos soportes, por ejemplo, sirven para el ensanchamiento y la conservación de lumen de vasos estrechados, haciendo para ello que, partiendo de lumen de vasos, con un catéter globo (balloon expandable) o de modo autoexpandible (self expanding) mantengan el lumen del vaso en un diámetro interior óptimo. El implante como tal sólo es necesario hasta que el vaso enfermo, por medio de procesos de reparación biológicos, pueda mantener con su propia fuerza el diámetro requerido de modo duradero. Este es el caso, por regla general, aproximadamente 4 semanas después de la implantación.
La permanencia duradera de un implante metálico, sin embargo, va unida a algunas desventajas. El implante, como cuerpo extraño, lleva a reacciones locales, y eventualmente también a reacciones sistémicas. Adicionalmente, se impide la autorregulación del segmento de vaso correspondiente. La carga permanente (pulsátil) del metal puede llevar a roturas por fatiga, que en el caso de implantes de gran lumen (por ejemplo, sistemas de cierre en pantallas), puede llevar a nuevos problemas médicos. Los soportes de vasos en lúminas menores (2,5-6 mm) generan aproximadamente en un 20% de los casos una nueva estenosis (denominada estenosis en extensor), que con el elevado número de los implantes lleva de modo cumulativo a una carga médica y económica adicional. En algunas regiones de los vasos (por ejemplo vasos extracraneales, arterias de las piernas), la estructura metálica se puede deformar de modo duradero por medio de la acción de fuerzas desde el exterior, con las consecuencias de una nueva obstrucción de los vasos, o de un cierre inducido de los vasos. Cada implante duradero va unido, adicionalmente, con problemas, en particular para pacientes jóvenes, ya que no se puede evitar una permanencia durante décadas.
Los implantes completamente degradables biológicamente se conocen hasta el momento sólo de materiales plásticos como, por ejemplo, del documento DE 2502884 C2. Allí se da a conocer un revestimiento de un implante ortopédico con polimetilmetracrilato, que es biodegradable. Otros materiales plásticos comprenden éster del ácido poliláctico y del ácido poliglicólico. Además, del documento EP 0006544 B1 se conoce un material cerámico biodegradable sobre base de fosfato de calcio, que sirve igualmente para el revestimiento de implantes metálicos.
Finalmente, del documento WO 81/02668 se conoce un implante ortopédico que presenta un cuerpo base metálico resistente a la corrosión, así como una capa intermedia metálica degradable biológicamente para la región de contacto con el hueso. Esta capa intermedia conforma conjuntamente con el cuerpo base una celda electroquímica, y genera una tensión eléctrica que propicia el crecimiento de los huesos. Al mismo tiempo reduce la capa de la superficie, que por ejemplo puede estar hecha de aleaciones de plata. Esto lleva al efecto pretendido de que el crecimiento de los huesos se vea influido de modo positivo el tiempo necesario que se requiera, y a continuación, después de la degradación completa del revestimiento de la superficie se acabe la excitación eléctrica.
Las sustancias biodegradables conocidas hasta el momento con base de polímeros se usan en la cirugía de vasos. Por un lado, sus características mecánicas y, por otra, la reacción de cuerpo extraño a continuación durante la biodegradación llevan a que sean el único material apropiado para una implantación. Los materiales/aleaciones metálicos poseen características mecánicas favorables (elasticidad, posibilidad de deformación, estabilidad) con una masa reducida, lo cual representa una condición importante para la aplicación por medio de sistemas de guiado de lumen delgado en un proceso transcutáneo.
Así pues, el objetivo de la presente invención es proporcionar un soporte de vasos de material biodegradable, que al mismo tiempo presente características mecánicas ventajosas.
Este objetivo se alcanza por soportes de vasos con las características de la reivindicación 1.
Puesto que el implante médico está fabricado a partir de un material metálico, degradable "in vivo" por corrosión, existen primariamente las ventajas mecánicas de materiales metálicos. La degradación corrosiva del implante dentro de una escala temporal ajustable por medio de la selección de material evita, por otro lado, que se produzcan los efectos negativos de larga duración del cuerpo extraño metálico. En este caso es ventajoso desde el punto de vista biológico que el material sea una aleación, cuya parte constituyente principal sea magnesio.
Se puede ejercer una influencia positiva sobre las características biológicas, mecánicas y químicas de los materiales cuando esté prevista como parte constituyente auxiliar manganeso, cobalto, níquel, cromo, cobre, cadmio, plomo, estaño, torio, circonio, plata, oro, paladio, platino, renio, silicio, calcio, litio, aluminio, cinc, hierro, carbono o azufre. Como material se prefiere en la actualidad, en su conjunto, una aleación de magnesio con una proporción de hasta un 40% de litio así como adición de hierro. Una corrosión especialmente buena al comienzo del tiempo de degradación se produce con una aleación o un metal sinterizado formado por dos partes iguales, por ejemplo, de cinc y hierro.
Se obtienen tiempos de degradación ventajosos, adicionalmente, con materiales con magnesio como la parte constituyente principal y que contienen:
- 0-40% de litio, 0-5% de hierro y por debajo del 5% de otros metales o tierras raras;
- 2-5% de aluminio, 0-12% de litio y 1-4% de tierras raras, en particular cerio, lantano, neodimio y/o praseodimio,
- 6-12% de litio, 2% de aluminio y 1% de tierras raras,
- 0-8% de litio, 2-4% de aluminio y 1-2% de tierras raras,
- 8,5-9,5% de aluminio, 0,15%-0,4% de manganeso, 0,45-0,9% de cinc
- 4,5-5,3% de aluminio, 0,28%-0,5% de manganeso, o
- 30-40% de litio y 0-5% de otros metales y/o tierras raras.
Estas aleaciones de magnesio están disponibles, por ejemplo, con las designaciones AZ91D, AM50A y AE42.
El implante médico se realiza en diferentes variantes básicas. Para un soporte de vasos está previsto como cuerpo básico una construcción en forma de tubo con un mecanizado adicional. Como sistema de cierre (por ejemplo Ductus Botalli, defectos septales congénitos y adquiridos, uniones shunt arterio-venosas) son ventajosas las formas de pantalla plegables pasivas y/o activas, las espirales o los cuerpos complejos. La invención también se puede emplear en oclusores como sistema de cierre para uniones de espacios huecos, vasos o sistemas de venas.
Adicionalmente es ventajoso prever el implante como dispositivo de fijación o de soporte para la fijación temporal de las piezas de tejido en forma de implantes o de transplantes.
Para el ajuste de la velocidad de corrosión de la sustancia es ventajoso que el grosor del material de la sustancia se seleccione dependiendo de la composición de la sustancia de tal manera que el proceso de degradación o corrosión "in vivo" esté fundamentalmente cerrado en un periodo entre 5 días y 6 meses, en particular entre 2 semanas y 8 semanas.
Con esto se consigue que después de un crecimiento del implante de tejido desaparezca el dispositivo de fijación que ya no se requiere.
A continuación, se proporcionan diferentes ejemplos de realización de la presente invención.
Ejemplo 1
Soporte de vasos
Una cánula intraluminal conforme a la invención se fabrica a partir de un cuerpo básico en forma de tubo del mecanizado metálico y posterior. Por lo que se refiere a la construcción mecánica, este tipo de cánulas intraluminales se conoce, por ejemplo, del documento EP 0221570 B1, siendo el material, sin embargo, un acero inoxidable resistente a la corrosión.
En la cánula intraluminal conforme a la invención según este ejemplo, el material es una aleación con magnesio como la parte constituyente fundamental y, dado el caso, las partes constituyentes auxiliares litio, hierro, cinc y trazas de níquel. La composición porcentual de la aleación de magnesio ha de estar aproximadamente en un intervalo del 50-98% de magnesio, 0-40% de litio, 0-5% de hierro y por debajo del 5% de otros metales. El grosor de la pared de la cánula intraluminal pretendida ha de tener un valor entre 50 y 100 \mum después del mecanizado.
En la práctica, la cánula intraluminal conforme a la invención se emplea de modo conocido con un catéter globo en un vaso sanguíneo estrechado enfermo, y allí se dilata o se libera como cánula intraluminal autoexpandible, manteniendo el vaso sanguíneo con el diámetro deseado. Se trata de modo efectivo una restenosis (recoil) que permanece sin implantación de cánula intraluminal y/o una herida del tejido inducida por medio de la dilatación. En el intervalo de 2-4 semanas, la cánula intraluminal es recubierta por tejido íntimo, y en primer lugar mantiene su función de soporte. El vaso sanguíneo recibe por medio del crecimiento del tejido, como consecuencia de procesos de autorreparación en la región de la cánula intraluminal implantada una nueva estabilidad propia. El lumen del vaso se estabiliza a un nuevo nivel óptimo. La elección del material de la aleación, conjuntamente con el grosor seleccionado de la pared llevan, por un lado, a que la cánula intraluminal se degrade en la pared del vaso sanguíneo poco a poco, y después de aproximadamente 4-12 semanas sólo esté presente en trazas. Desaparecen las desventajas descritas en la página 2 de un implante duradero.
Ejemplo 2
Sistema de cierre
Un sistema de cierre conforme a la invención (pantallita) se fabrica a partir de un esqueleto metálico en el que está fijada una pantallita de plástico. Este tipo de pantallitas se conocen, por ejemplo, hechas de la aleación MP35N o Nitinol. Este tipo de sistemas de cierre se usan para el cierre de defectos en las paredes de separación del corazón. El grosor de las paredes del armazón metálico tiene un valor de aproximadamente 500 mm. En la práctica, la pantallita se pliega de modo conocido, y se libera en el defecto que se ha de cerrar. En el intervalo de 3-4 semanas se cubre la pantallita por tejido propio del cuerpo, y por medio de este crecimiento de tejido obtiene una nueva estabilidad propia. La elección del material de la aleación, conjuntamente con el grosor de la pared del tejido lleva a que el armazón metálico se degrade dentro de un intervalo de 4 semanas a algunos meses, y después de un año sólo esté presente en trazas. La proporción de plástico de la pantallita se mantiene, lo cual no es crítico como consecuencia de la flexibilidad del material. La degradación de la parte metálica tiene la ventaja, en comparación con las pantallitas conocidas, de que también en el caso de cargas imprevisibles, por ejemplo en casos de accidentes de tráfico, no existe ningún peligro de que se produzca una perforación de las paredes de los vasos. En este caso ya se consigue la ventaja conforme a la invención cuando en primer lugar, por medio de la degradación, se produce una inestabilidad mecánica del armazón.
Ejemplo 3
Espirales para el cierre de vasos (oclusores)
Una espiral (coil) conforme a la invención se fabrica a partir de un material metálico arrollado en forma de hélice, y se dobla la espiral previamente. El diámetro del arrollamiento primario tiene un valor de 0,1-1 mm, dependiendo del vaso que se haya de cerrar. Este tipo de espirales (coils) son conocidas, por ejemplo, hechas de Nitinol, aleaciones de platino o aleaciones de wolframio.
En la práctica, la espiral de cierre (coil) de un modo conocido, se introduce en estado alargado en un catéter del corazón, y se hace avanzar a través de éste hasta el vaso que se ha de cerrar. Al producirse la liberación desde el catéter del corazón, la espiral vuelve a adoptar su forma original, y cierra el vaso que se ha de cerrar por medio de su lumen y de su trombogenidad, que puede ser aumentada por medio de dacrón u otras fibras. Después de la trombosis del vaso y del crecimiento de tejido cohesivo, el mecanismo de cierre recibe una nueva estabilidad. La espiral aplicada se degrada poco a poco, de manera que después de un año, el material implantado ya sólo existe en trazas.
Los ejemplos de realización mencionados hasta ahora se pueden fabricar con aleaciones de magnesio. No se conocen efectos tóxicos de los materiales en las concentraciones que se han de esperar.
Las aleaciones de magnesio tienen la ventaja de que por medio de la elección adecuada del resto de partes constituyentes de la aleación, se puede seleccionar de un modo muy preciso la velocidad de degradación "in vivo" que se ha de esperar. Adicionalmente, el magnesio se acepta muy bien desde el punto de vista fisiológico.

Claims (12)

1. Soporte de vasos de una sustancia metálica degradable "in vivo" por corrosión, caracterizado porque la sustancia es una aleación cuya parte constituyente principal es magnesio.
2. Soporte de vasos según la reivindicación 1, caracterizado porque la sustancia contiene 79-97% de magnesio, 2-5% de aluminio, 0-12% de litio y 1-4% de tierras raras, en particular cerio, lantano, neodimio y/o praseodimio.
3. Soporte de vasos según la reivindicación 1, caracterizado porque la sustancia contiene 85-91% de magnesio, 6-12% de litio, 2% de aluminio y 1% de tierras raras.
4. Soporte de vasos según la reivindicación 1, caracterizado porque la sustancia contiene 86-97% de magnesio, 0-8% de litio, 2-4% de aluminio y 1-2% de tierras raras.
5. Soporte de vasos según la reivindicación 1, caracterizado porque la sustancia contiene 8,5-9,5% de aluminio, 0,15%-0,4% de manganeso, 0,45-0,9% de cinc y el resto magnesio hasta 100%.
6. Soporte de vasos según la reivindicación 1, caracterizado porque la sustancia contiene 4,5-5,3% de aluminio, 0,28%-0,5% de manganeso y el resto magnesio hasta 100%.
7. Soporte de vasos según la reivindicación 1, caracterizado porque la sustancia contiene 55-65% de magnesio, 30-40% de litio y 0-5% de otros metales y/o tierras raras.
8. Soporte de vasos según una de las reivindicaciones precedentes, caracterizado porque el implante presenta un cuerpo básico fundamentalmente en forma de tubo.
9. Soporte de vasos según una de las reivindicaciones precedentes, caracterizado porque el grosor de material de la sustancia se selecciona dependiendo de la composición de la sustancia de tal manera que el proceso de degradación o corrosión "in vivo" está cerrado fundamentalmente en un intervalo de entre 5 días y 6 meses, en particular entre 2 semanas y 8 semanas.
10. Soporte de vasos según una de las reivindicaciones precedentes, caracterizado porque el grosor del material de la sustancia se selecciona dependiendo de la composición de la sustancia de tal manera que el proceso de degradación o corrosión "in vivo" está cerrado fundamentalmente en un intervalo de entre 6 meses y 10 años, en particular entre 1 año y 5 años.
11. Soporte de vasos según una de las reivindicaciones precedentes, caracterizado porque el proceso de degradación o corrosión "in vivo" lleva primero a una inestabilidad mecánica, antes de que esté cerrado fundamentalmente el proceso de degradación.
12. Soporte de vasos según una de las reivindicaciones precedentes, caracterizado porque la sustancia contiene como parte constituyente auxiliar uno o varios elementos del grupo que comprende lo siguiente: Mn, Co, Ni, Cr, Cu, Pb, Sn, Th, Zr, Ag, Au, Pd, Pt, Re, Si, Ca, Li, Al, Zn, Fe, C, S.
ES02019905T 1997-07-18 1998-07-17 Soporte metalico de vasos degradable "in vivo". Expired - Lifetime ES2243635T3 (es)

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AU9154198A (en) 1999-02-10
US20110301694A1 (en) 2011-12-08
WO1999003515A2 (de) 1999-01-28
PT1270023E (pt) 2005-10-31
US20110251669A1 (en) 2011-10-13
DK1270023T3 (da) 2005-09-05
DE59807846D1 (de) 2003-05-15
US8771751B2 (en) 2014-07-08
EP1270023A2 (de) 2003-01-02
DE59812873D1 (de) 2005-07-21
EP0923389A2 (de) 1999-06-23
IL129065A (en) 2006-04-10
ATE297767T1 (de) 2005-07-15
EP0923389A3 (de) 2002-08-28
EP1270023B1 (de) 2005-06-15
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IL172424A (en) 2008-08-07
EP0923389B1 (de) 2003-04-09
JP5352776B2 (ja) 2013-11-27
WO1999003515A3 (de) 1999-08-05
JP2011031063A (ja) 2011-02-17
JP2001511049A (ja) 2001-08-07
US20020004060A1 (en) 2002-01-10
EP1270023A3 (de) 2003-12-17
EP1552856A1 (de) 2005-07-13
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DE19731021A1 (de) 1999-01-21
ATE236667T1 (de) 2003-04-15

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