ES2200368T3 - Implante metalico degradable en vivo. - Google Patents

Implante metalico degradable en vivo.

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Publication number
ES2200368T3
ES2200368T3 ES98943732T ES98943732T ES2200368T3 ES 2200368 T3 ES2200368 T3 ES 2200368T3 ES 98943732 T ES98943732 T ES 98943732T ES 98943732 T ES98943732 T ES 98943732T ES 2200368 T3 ES2200368 T3 ES 2200368T3
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vivo
implant
corrosion
iron
medicinal
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Bernd Heublein
Gerd Hausdorf
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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
    • A61L31/14—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
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    • A61B17/1204—Type of occlusion temporary occlusion
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    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
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    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
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    • 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
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    • 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
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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
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    • 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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
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    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A—HUMAN NECESSITIES
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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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  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Inorganic 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

LA INVENCION ESTA RELACIONADA CON UN IMPLANTE MEDICO DE UN MATERIAL METALICO. LOS EFECTOS PERJUDICIALES A LARGO PLAZO SE EVITAN GRACIAS A QUE EL IMPLANTE SE DEGRADA POR CORROSION EN UN PLAZO DEFINIDO DESPUES DE HABER CUMPLIDO SU FUNCION TEMPORAL DE APOYO.

Description

Implante metálico degradable in vivo.
La presente invención se refiere a implantes de materiales metálicos para su utilización en el cuerpo humano o de animales.
Tales implantes son básicamente conocidos desde hace mucho tiempo. Los primeros implantes fueron desarrollados para fines ortopédicos, por ejemplo tornillos y clavos para fijar roturas de huesos. Estos estaban compuestos primeramente por aleaciones de hierro relativamente sencillas, que bajo condiciones in vivo tendían a la corrosión. La corrosión dio lugar a que en la inmediata proximidad del hueso los metales quedasen liberados como iones, que dieron un estímulo indeseado para el crecimiento del tejido del hueso. El hueso creció más intensamente que lo que se hubiera deseado en realidad y de lo que era necesario. De esta manera se dañó el material sano de los huesos.
Por esta razón ha habido esfuerzos para fabricar los implantes metálicos básicamente a partir de materiales lo más resistentes posible a la corrosión. En la actualidad se utilizan al respecto principalmente aceros aleados resistentes a la corrosión, tántalo y titanio. Estos implantes permanecen presentes tras la implantación como cuerpos extraños y son reconocidos como tales por el organismo. Los mismos pueden retirarse solamente mediante una segunda operación.
Además, son conocidos implantes metálicos en el campo de la cirugía vascular y de la cardiología, angiología y radiología. Estos implantes incluyen por ejemplo endoluminales y soportes de vasos (extensores) para el tratamiento de lesiones. Estos soportes sirven por ejemplo para ensanchar y mantener el lumen en vasos estrechados, tal que partiendo del lumen del vaso y mediante un catéter de globo (ballon expandable) o bien de forma autoexpandible (self expanding) mantienen el lumen del vaso con un diámetro interior correspondientemente óptimo. El implante es necesario sólo hasta que el vaso enfermo, debido a procesos biológicos de reparación, por su propia fuerza pueda mantener el diámetro necesario de manera duradera. Este es generalmente el caso unas 4 semanas tras la implantación.
La permanencia duradera de un implante metálico implica no obstante algunos inconvenientes. El implante da lugar, como cuerpo extraño, a reacciones locales y eventualmente también sistémicas. Adicionalmente, se ve obstaculizada la autorregulación del segmento de vaso afectado. La carga permanente (pulsatoria) del metal puede dar lugar a roturas por fatiga, lo cual en implantes de gran lumen (por ejemplo sistemas de cierre como protecciones) dan lugar a nuevos problemas médicos. Los soportes de vasos en pequeños lúmenes (2,5 - 6 mm) generan en aproximadamente un 20% de los casos una nueva estenosis (la llamada estenosis en extensor) lo cual da lugar, debido al elevado número de implantados acumulados, a una carga adicional importante tanto médica como económica. En algunas regiones de los vasos (por ejemplo vasos extracraneales, arterias de las piernas) la estructura metálica puede deformarse de manera duradera debido a la actuación de fuerzas exteriores, con las consecuencias de una nueva obstrucción de los vasos o bien de un cierre inducido de los vasos. Cada implante permanente implica adicionalmente problemas, en particular en pacientes jóvenes, debido a que es inevitable su permanencia durante décadas.
Los implantes totalmente degradables biológicamente sólo se conocen hasta ahora a partir de materiales de plástico, por ejemplo por la DE 2502884 C2. Allí se da a conocer un recubrimiento de un implante ortopédico con metacrilato de polimetilo que es biodegradable. Otros materiales plásticos incluyen éster de ácido poliglicol y poliactídico. Además, por la EP 0006544 B1 se conoce un material cerámico biodegradable a base de fosfato de calcio, que sirve igualmente para recubrir implantes metálicos.
Finalmente, por la WO 81/02668 se conoce un implante ortopédico que presenta un cuerpo de base metálico resistente a la corrosión, así como una capa intermedia metálica biológicamente degradable para la zona de contacto con el hueso. Esta capa intermedia forma juntamente con el cuerpo de base una célula electroquímica y genera una tensión eléctrica que fomenta el crecimiento del hueso. Simultáneamente, se descompone la capa superficial, que puede estar compuesta por ejemplo por aleaciones de plata. Esto da lugar al efecto pretendido de que el crecimiento del hueso se vea influido positivamente mientras ello sea necesario y a continuación, tras la descomposición completa del recubrimiento superficial, descienda la estimulación eléctrica.
Las sustancias biodegradables conocidas hasta ahora a base de polímeros se utilizan en la cirugía vascular. Sus propiedades mecánicas por un lado y la subsiguiente reacción ante cuerpos extraños durante la biodegradación por otro, dan lugar a que de por sí como único material sean inadecuadas para un implante. Los materiales/aleaciones metálicos poseen propiedades mecánicas favorables (elasticidad, deformabilidad, estabilidad) cuando su masa es pequeña, lo cual es una premisa importante para la aplicación mediante sistemas de guía de lúmenes delgados en procedimientos trascutáneos.
Es por lo tanto tarea de la presente invención poner a disposición implantes de material biodegradable que a la vez presenten propiedades mecánicas ventajosas.
Esta tarea se resuelve mediante implantes con las particularidades de las reivindicaciones 1, 2 y 3.
Debido a que el implante médico está fabricado a partir de un material metálico, que mediante corrosión puede degradarse in vivo, son preeminentes las ventajas mecánicas de los materiales metálicos. La descomposición corrosiva del implante dentro de una escala de tiempo ajustable mediante la elección del material evita, por otro lado, que se presenten los efectos negativos a largo plazo de los cuerpos extraños metálicos. Al respecto, es ventajoso biológicamente que el material sea hierro puro, dado el caso, con una proporción de hasta un 7% de carbono o una aleación cuyo componente principal sea el hierro. Actualmente se prefiere hierro como componente principal.
Las propiedades biológicas, mecánicas y químicas de los materiales pueden verse influidas positivamente cuando se prevé como componente secundario manganeso, cobalto, níquel, cromo, cobre, cadmio, plomo, estaño, torio, zirconio, plata, oro, paladio, platino, renio, silicio, calcio, litio, aluminio, cinc, hierro, carbono o azufre. Como material en su conjunto se prefiere actualmente una aleación de hierro con una reducida proporción de aluminio, magnesio, níquel y/o cinc.
El implante médico se realiza en varias variantes básicas. Para un soporte vascular se prevé como cuerpo de base una estructura tubular con tratamiento adicional. Como sistema de cierre (por ejemplo ductus botalli, defectos de septo innatos y adquiridos, uniones de shunt arteriovenosas) son ventajosas formas de protección que se despliegan pasiva y/o activamente, espirales o cuerpos complejos. La invención puede también utilizarse en oclusores como sistemas de cierre para uniones de cavidades, vasos o sistemas de marcha.
Es además ventajoso prever el implante como dispositivo de fijación o soporte para la fijación temporal de partes de tejidos en forma de implantes o transplantes.
Para ajustar la velocidad de corrosión del material es ventajoso que el espesor del material se elija en función de la composición del material de tal manera que el proceso de descomposición o corrosión in vivo finalice en prácticamente entre 5 días y 6 meses, en particular entre 2 semanas y 8 semanas.
Entonces se logra que tras el crecimiento del implante del tejido desaparezca el dispositivo de fijación que ya no se necesita.
A continuación se indican diversos ejemplos de ejecución de la presente invención.
Ejemplo 1 Soporte vascular
Un extensor correspondiente a la invención se fabrica a partir de un cuerpo de base tubular de elaboración metálica y subsiguiente. Desde el punto de vista de su estructura mecánica, tales extensores son conocidos por ejemplo por la EP 0221570 B1, siendo no obstante el material un acero noble resistente a la corrosión.
En el extensor correspondiente a la invención de este ejemplo el material es una aleación con el componente principal hierro y los componentes secundarios cromo y níquel, así como dado el caso indicios de otros aditivos. La composición procentual de la aleación de hierro debe estar aproximadamente en la gama de 88 - 89% hierro, 0,5 - 7% cromo y 0,5 - 3,5% níquel, así como menos de un 5% otros metales. El espesor de la pared del soporte del extensor debe ser tras la elaboración de entre 50 y 100 \mum.
En la práctica, el extensor correspondiente a la invención se introduce de la manera conocida con un catéter de globo en un vaso de sangre estrechado enfermo y allí se dilata o se libera como extensor autoexpansor, manteniendo el mismo el vaso sanguíneo en el diámetro deseado. Una reestenosis (retroceso) que permanezca sin la implantación del extensor y/o un desgarre del tejido inducido por la dilatación, son tratados de manera totalmente efectiva. En un plazo de 2 - 4 semanas, el extensor es cubierto por tejido interno y conserva su función de soporte. El vaso sanguíneo obtiene, debido al crecimiento del tejido a causa de los procesos de autoreparación en la zona del extensor implantado, una nueva estabilidad propia. El lumen del vaso se estabiliza en un nivel óptimo. La elección del material de la aleación juntamente con el espesor de pared elegido, dan lugar por otro lado a que el extensor se descomponga progresivamente en la pared del vaso de sangre y tras unas 4 - 12 semanas sólo exista como indicios. Los inconvenientes reflejados en la página 2 de un implante permanente, desaparecen.
Ejemplo 2 Sistema de cierre
Un sistema de cierre correspondiente a la invención (protección) se fabrica a partir de un esqueleto metálico al que está fijada una protección de plástico. Tales protecciones son conocidas por ejemplo por la aleación MP35N o nitinol. Tales sistemas de cierre se utilizan para el cierre de defectos en las paredes de separación del corazón. El espesor de pared del entramado metálico es de alrededor de 500 mm. En la práctica, se pliega la protección de la manera conocida y se libera en el defecto a cerrar. Dentro de 3 - 4 semanas, la protección es cubierta por tejido propio del cuerpo y obtiene mediante este crecimiento del tejido una nueva estabilidad propia. La elección del material de la aleación juntamente con el espesor de pared del tejido, da lugar a que el entramado metálico se descomponga dentro de unas 4 semanas hasta algunos meses y a que tras un año sólo exista como indicios. La proporción de plástico de la protección se conserva, lo cual no es crítico debido a la flexibilidad del material. La descomposición de la parte metálica tiene respecto a las protecciones conocidas la ventaja de que también cuando hay cargas imprevistas, por ejemplo en accidentes de tráfico, no hay peligro de rotura de las paredes del vaso. Entonces se logra ya la ventaja correspondiente a la invención al lograrse debido a la degradación una inestabilidad mecánica del entramado.
Ejemplo 3 Espirales para el cierre de vasos (oclusores)
Un espiral (coil) correspondiente a la invención se fabrica a partir de un material metálico arrollado en forma de hélice y se realiza un doblado previo de la espiral. El diámetro de la bobina primaria es de 0,1 - 1 mm, en función del vaso a cerrar. Tales espirales (coil) son conocidas por ejemplo por nitinol, aleaciones de platino o aleaciones de wolframio.
En la presente forma constructiva correspondiente a la invención el material es una aleación con el componente principal hierro, los componentes secundarios níquel y/o cromo, así como indicios de magnesio y cinc.
En la práctica, la espiral de cierre (coil) se introduce de la manera conocida en forma estirada en un catéter para el corazón y a través de éste se desliza hasta el vaso a cerrar. Cuando se libera del catéter del corazón, asume la espiral de nuevo su forma anterior y obtura mediante su lumen y su trombogeneidad, que puede aumentarse mediante dacrón o bien otras fibras, el vaso a cerrar. Tras la trombocización del vaso y el crecimiento del tejido de unión, el mecanismo de cierre logra una nueva estabilidad propia. Las espirales aplicadas se descomponen progresivamente, de manera que tras aproximadamente un año el material implantado sólo existe como indicios.
Los ejemplos de ejecución citados hasta ahora pueden fabricarse con aleaciones de hierro. No se conocen efectos tóxicos de los materiales en las concentraciones que son de esperar.
Las aleaciones de hierro son ventajosas en cuanto a su estabilidad mecánica, lo que se refleja en los pequeños espesores de pared posibles para los implantes. El material para la aleación puede por lo tanto elegirse en función del caso de aplicación.

Claims (8)

1. Implante medicinal a partir de un material metálico degradable mediante corrosión in vivo,
caracterizado porque el material es hierro puro.
2. Implante medicinal a partir de un material metálico degradable mediante corrosión in vivo,
caracterizado porque el material contiene como componente principal hierro y 0,5% a 7% de carbono.
3. Implante medicinal a partir de un material metálico degradable mediante corrosión in vivo,
caracterizado porque el material contiene como componente principal 88 - 99,8% de hierro, 0,1% - 7% de cromo y 0 - 3,5% de níquel, así como menos de un 5% de otros metales.
4. Implante medicinal según una de las reivindicaciones precedentes,
caracterizado porque el implante es un soporte vascular, en particular un extensor.
5. Implante medicinal según una de las reivindicaciones precedentes,
caracterizado porque el implante es un dispositivo de fijación o soporte para la fijación temporal de implantes de tejido o transplantes de tejido, en particular un clip.
6. Implante medicinal según una de las reivindicaciones precedentes,
caracterizado porque el espesor del material se elige en función de la composición del material, de tal manera que el proceso de degradación o corrosión in vivo queda prácticamente cerrado en la gama de 5 días hasta 6 meses, en particular entre 2 semanas y 8 semanas.
7. Implante medicinal según una de las reivindicaciones precedentes 1 a 5,
caracterizado porque el espesor del material se elige en función de la composición del material, de tal manera que el proceso de degradación o corrosión in vivo queda cerrado en la gama de 6 meses hasta 10 años, en particular entre 1 año y 5 años.
8. Implante medicinal según una de las reivindicaciones precedentes,
caracterizado porque el proceso de degradación o corrosión in vivo da lugar primeramente a una inestabilidad mecánica antes de que finalice prácticamente el proceso de degradación.
ES98943732T 1997-07-18 1998-07-17 Implante metalico degradable en vivo. Expired - Lifetime ES2200368T3 (es)

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DE19731021A DE19731021A1 (de) 1997-07-18 1997-07-18 In vivo abbaubares metallisches Implantat

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ES02019905T Expired - Lifetime ES2243635T3 (es) 1997-07-18 1998-07-17 Soporte metalico de vasos degradable "in vivo".
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EP1270023B1 (de) 2005-06-15
WO1999003515A2 (de) 1999-01-28
EP0923389A2 (de) 1999-06-23
IL172424A (en) 2008-08-07
US8771751B2 (en) 2014-07-08
DK1270023T3 (da) 2005-09-05
DE59807846D1 (de) 2003-05-15
WO1999003515A3 (de) 1999-08-05
ATE236667T1 (de) 2003-04-15
US20110251669A1 (en) 2011-10-13
EP1270023A3 (de) 2003-12-17
AU9154198A (en) 1999-02-10
IL129065A (en) 2006-04-10
EP0923389B1 (de) 2003-04-09
ES2243635T3 (es) 2005-12-01
DE19731021A1 (de) 1999-01-21

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