ES2534550T3 - Implante bioabsorbible poroso - Google Patents

Implante bioabsorbible poroso Download PDF

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Publication number
ES2534550T3
ES2534550T3 ES09740770.4T ES09740770T ES2534550T3 ES 2534550 T3 ES2534550 T3 ES 2534550T3 ES 09740770 T ES09740770 T ES 09740770T ES 2534550 T3 ES2534550 T3 ES 2534550T3
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implant
radiopaque
bioabsorbable
alginate
marker
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Amit Govil
Michael L. Jones
Paul Lubock
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SenoRx Inc
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SenoRx Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/146Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/0077Special surfaces of prostheses, e.g. for improving ingrowth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58Materials at least partially resorbable by the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148Materials at least partially resorbable by the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/18Materials at least partially X-ray or laser opaque
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • A61L2300/104Silver, e.g. silver sulfadiazine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/44Radioisotopes, radionuclides

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Surgery (AREA)
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  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Molecular Biology (AREA)
  • Cardiology (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
  • Medicinal Preparation (AREA)
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Abstract

Un implante para implantación en una cavidad corporal y para el recrecimiento de tejido antes de que se produzca una bioabsorción significativa del implante, comprendiendo el implante un cuerpo poroso formado por un material bioabsorbible con poros en la superficie de entre 20 y 80 μm de tamaño y poros interiores de entre 50 y 200 μm de tamaño, un agente de obtención de imágenes radioopaco que facilite la obtención de imágenes de los márgenes exteriores del implante y un marcador de orientación interior separado hacia el interior de los márgenes exteriores del implante para facilitar la orientación relativa entre el implante y una fuente de radiación, caracterizado por que el material bioabsorbible comprende al menos en parte un chitosano o alginato bioabsorbible.

Description

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DESCRIPCIÓN
Implante bioabsorbible poroso
Campo de la invención
La invención está dirigida, en general, a implantes bioabsorbibles porosos para cavidades en tejidos blandos, tal como en tejido de mama tras procedimientos de biopsia o tumorectomía. Los implantes con las características de la invención son particularmente adecuados como soporte de dichas cavidades y se pueden obtener imágenes para facilitar la irradiación conformal tridimensional.
Antecedentes de la invención
La biopsia y otros procedimientos de extirpación de tejidos en tejidos blandos con frecuencia pueden conducir a formación de hoyos y a otras desfiguraciones a menos que se introduzcan prótesis o implantes en el interior de la cavidad de la que se ha extraído tejido. Véase, por ejemplo, la patente de EE.UU. Nº 6.214.045, la patente de EE.UU. Nº 6.638.308 y la patente de EE.UU. Nº 6.881.226 (Corbitt y col.). Además, después de los procedimientos de extirpación de tejido que implica el cáncer, tales como tumorectomías, suele ser deseable irradiar la cavidad de revestimiento para garantizar un tratamiento eficaz de cualquier célula cancerosa que pueda quedar. Los documentos WO 00/38579 y WO 01/08578 A1 describen una serie de diferentes disposiciones de marcadores. En algunas disposiciones, el marcador puede estar hecho de un polímero, en particular un gel, incluyendo un aditivo radioopaco, mientras que otras disposiciones pueden estar hechas con colágeno poroso. El documento US 2006/0155190 A1 describe el uso de una pastilla de gelatina que incorpora un marcador radioopaco y la introducción de marcadores diluidos en un punto de biopsia, así como esferas que pueden estar llenas de aire y un globo inflable. El documento US 2005/0234336 describe marcadores que incluyen una disposición en la que el marcador comprende un cuerpo de, preferentemente, espuma comprimida biodegradable dentro de una cáscara junto con un marcador radioopaco incluido en el cuerpo. El documento US 2008/0114329 describe un tratamiento de la cavidad tras la biopsia, en el que se pueden introducir implantes de colágeno poroso para facilitar el crecimiento del tejido. Se pueden introducir partículas o artículos radioopacos para hacer de forma selectiva que el implante sea radioopaco.
Aunque se han propuesto numerosos implantes para llenar las cavidades del cuerpo después de procedimientos de extirpación de tejido, tales como tumorectomías, pocos han tenido un éxito comercial significativo.
Sumario de la invención
La invención está dirigida en general a un implante para una cavidad corporal que comprende un cuerpo poroso formado por un material bioabsorbible que tienen una vida in vivo de al menos dos semanas pero no superior a veinte semanas, preferentemente de al menos tres semanas pero no más de aproximadamente diez semanas. El implante tiene una porosidad o es capaz de formar una porosidad tal para formar un armazón temporal dentro de una cavidad corporal de la que se ha extirpado tejido con el fin de garantizar un crecimiento de tejido en el interior de la cavidad antes de que se produzca una bioabsorción significativa del implante. El implante se proporciona con un agente de obtención de imágenes radioopaco para garantizar que se pueden obtener imágenes de al menos los márgenes exteriores, tal como mediante TC, con el fin de formular programas de dosificación. Adicionalmente, el implante se proporciona con un marcador de orientación interior, tal como al menos dos y, preferentemente tres, elementos radioopacos dentro del cuerpo del implante para facilitar la orientación de la cavidad, y una fuente de radiación exterior, tal como un acelerador lineal para la irradiación conformal del tejido que reviste la cavidad, que es más probable que contenga células cancerosas residuales. También son adecuados los marcadores de orientación impulsados con energía externa. Véase, por ejemplo, la patente de EE.UU. Nº 7.535.363.
El material bioabsorbibles del implante es, al menos en parte, un chitosano o alginato bioabsorbible. El cuerpo también puede incluir un material bioabsorbible seleccionado del grupo que consiste en dextrano, almidón, ácido poliláctico, ácido poliglicólico y copolímeros de los mismos, y gelatina, preferentemente gelatina reticulada. El agente de obtención de imágenes radioopaco se puede seleccionar del grupo de sulfato de bario, carbonato de bario, cloruro de plata, yoduro de plata, nitrato de plata, carbonato de plata, óxido de cinc y partículas o polvos metálicos radioopacos. El agente de obtención de imágenes radioopaco está en forma de partículas y, preferentemente, en polvo, para facilitar la obtención de imágenes, en particular los márgenes exteriores del implante. La pluralidad de los elementos marcadores para orientación que se introducen en el cuerpo del implante se pueden seleccionar de oro, titanio, platino, iridio, tántalo, tungsteno, plata, renio y acero inoxidable no magnético. Estos marcadores metálicos se incorporan en el implante para producir una línea (Definida por dos elementos marcadores) y, preferentemente, un plano (definido por tres elementos marcadores) que permita una fuente de radiación exterior, tal como un acelerador lineal, y la cavidad a alinear para una irradiación eficaz del tejido que reviste la cavidad,
El implante se dimensiona y da forma para que encaje dentro de la cavidad corporal y conformar el tejido que reviste la cavidad alrededor del implante. Generalmente, el implante tendrá una forma esférica u ovalada, aunque se pueden usar otras formas. Se prefiere que el implante se expanda algo tras su despliegue en el interior de la cavidad, por ejemplo los materiales de implantes se hinchan (al captar agua o hidratarse) tras el contacto con fluidos con base acuosa, tales como fluidos corporales y otros fluidos que puedan estar en la cavidad para garantizar que el
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tejido que reviste la cavidad se adecua al exterior del implante. La forma final del revestimiento tisular conformado no tienen que ser la misma que la forma del implante original, pero la forma conformada del revestimiento tisular se simplifica, lo que facilita las determinaciones de las dosis y simplifica los patrones de irradiación. Las cavidades corporales resultantes de procedimientos de tumorectomía, tal como en una mama de una mujer, pueden variar de aproximadamente 0,5 a aproximadamente 8 cm y normalmente son de aproximadamente 3 a aproximadamente 6 cm en las dimensiones máximas, por lo que el implante debería tener aproximadamente el mismo tamaño y, preferentemente, ligeramente más grande para asegurar la conformación del tejido.
El implante es poroso y tiene una resistencia a la compresión suficiente para soportar el tejido mamario. La porosidad debería ser suficiente para facilitar el crecimiento del tejido cuando se despliega dentro de la cavidad intracorpórea. La porosidad puede tener un tamaño de poro que varía de aproximadamente 10 a aproximadamente 600 micrómetros. Los poros de la superficie normalmente tienen de aproximadamente 20 a aproximadamente 80 micrómetros y los poros interiores tienen de aproximadamente 50 a aproximadamente 200 micrómetros. La porosidad del implante se forma, preferentemente, en el implante antes del despliegue dentro de la cavidad corporal con el fin de controlar el tamaño y la forma del implante. La porosidad se puede formar eliminando fluidos o disolviendo materiales solubles de un cuerpo solidificado después de su formación o incorporando un gas o un agente formador de gas en una mezcla que forma el implante antes de fijar la forma del implante. Preferentemente, otro ejemplo podría ser congelar una solución acuosa del chitosano o alginato en un molde para formar un cuerpo, después liofilizar el cuerpo congelado (preferentemente fuera del molde) para eliminar el fluido acuoso congelado.
Se pueden incorporar en el implante diversos agentes terapéuticos o diagnósticos, incluyendo, por ejemplo, agentes hemostáticos para formar trombos en el lugar intracorpóreo, agentes anestésicos para controlar el dolor, agentes quimioterapéuticos para tratar el tejido neoplásico residual o agentes colorantes para facilitar la posterior localización visual del lugar. También se pueden incorporar en el marcador fibroso antibióticos, agentes antifúngicos y agentes antivirales.
El implante se puede formar mezclando aproximadamente 0,5 -4 % (en peso) de chitosano en una solución acuosa acidificada (1 -25 % en peso de ácido acético) junto con aproximadamente 0,5 %-5 % (en peso) del agente de obtención de imágenes radioopaco en polvo, tal como sulfato de bario, para facilitar la posterior obtención de imágenes en remoto del implante. Se puede usar hasta un 10 % de chitosano, pero la solubilidad máxima del chitosano es de aproximadamente 4,5 % (en peso). La mezcla puede hacerse bastante viscosa a las cantidades más elevadas de chitosano. La mezcla se coloca en un molde adecuado que presente una forma deseada y la mezcla se congela a de -1° a -196° C durante aproximadamente 6 -12 horas. El cuerpo congelado se extrae del molde y después se introduce en un liofilizador (aproximadamente 3 días) para eliminar el agua y formar un cuerpo poroso. Después de liofilizar en el liofilizador, el cuerpo que contiene chitosano se neutraliza usando una base o tampón, tal como hidróxido amónico (5 -20 % en peso), se lava la base o el tampón con agua desionizada y después se seca. El implante poroso tiene la consistencia del tejido mamario.
En el caso de un alginato, un alginato soluble, tal como alginato sódico, se mezcla en una solución acuosa junto con un agente radioopaco, como se ha tratado anteriormente. La mezcla de alginato -agente radioopaco se vierte en un molde adecuado y después se liofiliza o se deja secar al aire para eliminar el agua y formar el cuerpo poroso. El cuerpo poroso se extrae del molde y el alginato soluble se convierte en un alginato menos soluble introduciendo el cuerpo poroso en una solución de cloruro cálcico que convierte el alginato sódico en el alginato cálcico, menos soluble. Durante el mezclado también se pueden incorporar en la solución de alginato sódico burbujas de aire para proporcionar porosidad.
La pluralidad de los elementos marcadores radioopacos se puede incorporar en el implante durante su formación bien a medida que la solución solidifica en el molde o bien una vez que se ha formado el cuerpo. La pluralidad de elementos marcadores deberá colocarse interiormente desde el margen exterior del implante. Se pueden formar pasillos en el cuerpo poroso en ubicaciones deseadas para los elementos de orientación radioopacos.
Preferentemente, el chitosano tiene una pureza elevada y un peso molecular alto. El grado de desacetilación es de aproximadamente 60 a 100 % y, preferentemente, está entre 70 y 100 %.
Estas y otras ventajas de la invención serán más evidentes a partir de la siguiente descripción detallada de las formas de realización junto con las figuras ilustrativas acompañantes.
Breve descripción de las figuras
La figura 1 es un diagrama de flujo que ilustra de forma esquemática un procedimiento para formar un implante usando las características de la presente invención.
La figura 2 es una vista en alzado esquemática en la sección de un sistema para mezclar componentes con el fin de fabricar un implante usando las características de la invención.
La figura 3 es una vista en alzado esquemática en sección que ilustra el vertido de la mezcla en un molde para formar el implante.
La figura 4 es una vista en alzado esquemática en sección que ilustra la introducción del cuerpo poroso seco en 3
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una solución de CaCl2 para convertir el alginato soluble en un alginato menos soluble.
La figura 5 es una vista en sección transversal de un implante después de tratar en la solución de CaCl2.
La figura 6 es una sección de un implante usando las características de la invención que tiene un marcador de orientación con tres elementos radioopacos.
La figura 7 es una microfotografía electrónica de barrido (30x) de una vista transversal de un implante usando las características de la invención tomada cerca de la superficie del implante.
La figura 8 es una microfotografía electrónica de barrido (30x) de una vista transversal de un implante usando las características de la invención tomada en el interior del implante.
Descripción detallada de las realizaciones de la invención
La figura 1 es un diagrama de flujo que ilustra de forma esquemática un procedimiento para formar un implante que usa las características de la invención. Específicamente, en la primera etapa 10 se mezcla un material bioabsorbible (chitosano o un alginato soluble) con agua junto con un agente de obtención de imágenes radioopaco en polvo o en partículas, tal como sulfato de bario. También se puede incorporar en la mezcla un agente formador de poros, tal como un gas. En la segunda etapa 11, la mezcla, que ha gelificado en cierta medida, se vierte en un molde. El molde tiene una superficie de formación que da a la mezcla una forma deseada cuando se solidifica o endurece hasta el punto en que se autosoporta en la forma que se le ha dado. En el caso ilustrado, la forma es esférica. En la tercera etapa 12, el cuerpo formado se extrae del molde y en la etapa 13 se extrae el agua del cuerpo mediante, preferentemente, liofilización o secado al aire, para formar un cuerpo poroso. En la cuarta etapa 14a, si el cuerpo poroso está formado por chitosano, el ácido residual en el cuerpo se neutraliza con una base adecuada, tal como hidróxido amónico, se lava y se seca. En la cuarta etapa 14b, si el cuerpo poroso está formado por alginato, el cuerpo poroso se sumerge en una solución de CaCl2, en la que al menos parte del alginato sódico se convierte en el alginato de calcio, menos soluble, se lava y se seca. Uno o más marcadores de orientación se pueden insertar en el cuerpo poroso mediante una cánula o se pueden proporcionar al cuerpo poroso uno o más pasillos para poder empujar el o los marcadores de orientación hacia la ubicación deseada dentro del cuerpo.
La figura 2 ilustra la adición de chitosano bioabsorbibles o un alginato sódico o sulfato de bario en polvo a un cuerpo de agua 20 contenida en un recipiente adecuado 21. El agua 20 se mezcla con el elemento de mezclado o propelente 22 unido a un eje de rotación 23. Se pueden batir burbujas en la masa o se pueden introducir en el cuerpo de agua 20 otros agentes formadores de poros. Como se muestra en la figura 3, el cuerpo de fluido o gel se vierte después en un molde esférico 24 que tiene una mitad superior 25 y una mitad inferior 26 interconectadas por abrazaderas 27 y 28. Una vez fijado el cuerpo se extrae el agua mediante, por ejemplo, liofilización, para formar un cuerpo esférico poroso 29. Si el cuerpo contiene chitosano, se trata al cuerpo con una base para neutralizar el ácido residual. Si el cuerpo contiene alginato sódico, como se muestra en la figura 4, el cuerpo esférico poroso 29 se introduce en una solución acuosa de CaCl2 30 en el recipiente 31, en el que al menos parte del alginato sódico se convierte en alginato cálcico que precipita rápidamente. Una sección transversal del implante final 32 se ilustra esquemáticamente en la figura 5.
La figura 6 es una sección transversal de un implante 33 que tiene tres elementos radioopacos que pueden obtener imágenes 34 (p. ej., partículas de oro) situados en el interior del implante y separados hacia dentro de la superficie exterior. Los tres elementos radioopacos (p. ej., partículas de oro que se pueden ver) se muestran en los vértices de un triángulo equilátero que se puede usar como guía para la colocación relativa entre la mama del paciente y un acelerador lineal para proporcionar irradiación eficaz del tejido que rodea a la cavidad de tumorectomía en la mama del paciente. Como mínimo, deberá haber dos elementos radioopacos para definir una línea y, preferentemente, tres para definir un plano. No obstante, puede haber más pero deberían estar en el mismo plano. El agente de obtención de imágenes radioopaco (sulfato de bario) en el implante permite obtener imágenes de los márgenes exteriores del implante en una TC, lo que facilita la determinación de un plan de dosis de irradiación adecuado para que el acelerador lineal garantice un tratamiento eficaz de cualquier célula cancerosa residual en el revestimiento de la cavidad tras la tumorectomía.
Ejemplo I
Se prepare una solución acuosa ácida (12,5 % de ácido acético) que contiene 4 % en peso de chitosano y 2 % en peso de sulfato de bario. La solución se colocó en un molde esférico y después se congeló en el molde a -30 °C durante 16 horas. El cuerpo congelado se extrajo del molde y se liofilizó durante 3 días para eliminar el agua. El cuerpo liofilizado se neutralizó en una solución al 10 % de hidróxido amónico durante una hora y después se limpió de hidróxido amónico con agua desionizada. El cuerpo se secó al vacío durante 16 horas. El cuerpo tenía la consistencia esponjosa similar al tejido mamario y tenía una resistencia a la compresión suficiente para soportar el tejido mamario que rodea a una cavidad de tumorectomía. Comprendía 67 % de chitosano y 33 % de sulfato de bario. En la figura6 se muestra una microfotografía SEM (30X) de la porosidad de la superficie y en la figura 7 se muestra una microfotografía SEM (30X) de la porosidad central. El implante tenía la consistencia esponjosa cercana a la del tejido mamario. El implante podría hacerse más duro aumentando la cantidad de chitosano.
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Ejemplo II
Una cantidad de alginato sódico (de 0,5 a aproximadamente 4 % (en peso)) se disuelve en agua para formar una pasta, fluido viscoso o gel y se introduce en la mezcla aire u otro gas biocompatible. La mezcla se coloca en un molde de un forma de implante deseado y después se liofiliza o se seca al aire en la forma deseada. La estructura del implante formado de alginato sódico se introduce en una solución de cloruro cálcico (de 0,5 a aproximadamente 4 % (en peso)), en el que al menos parte del alginato sódico se convierte en alginato cálcico, que precipita. La estructura porosa precipitada del implante se introduce en una cavidad corporal de la que se ha extraído el tejido. El implante permanece en el lugar durante un periodo de tiempo suficiente como para servir de armazón para facilitar el crecimiento de tejido en el interior de la cavidad corporal. En la mezcla de alginato sódico-agua se puede incorporar almidón, tal como almidón de maíz en forma de partículas finamente divididas de forma que cuando se forma alginato cálcico, precipita alrededor de las partículas de almidón para minimizar la reducción del tamaño durante la conversión de alginato sódico en alginato cálcico. El almidón se degrada rápidamente en la cavidad corporal en presencia de fluido corporal. El alginato sobre la superficie del implante se degrada para abrir las partículas de almidón incorporadas hasta la degradación que proporciona una evolución de porosidad. La proporción en peso entre el almidón y el alginato puede variar de aproximadamente 15:1 a aproximadamente 1:1.
Ejemplo III
Este ejemplo es similar al ejemplo II a excepción de que se mezclan 30 gramos de los gránulos de sal (NaCl) con aproximadamente 30 ml de 3 % (en peso) de la solución acuosa de alginato sódico. La solución se introduce en un molde esférico después se congela durante 4 horas. El implante congelado se extrajo del molde y se introdujo en una solución de 2 % (en peso) de cloruro cálcico, de modo que se forma gel de alginato cálcico y se disuelve al menos algunos de los gránulos de sal incorporados para formar una estructura porosa. El implante tenía la consistencia esponjosa cercana a la del tejido mamario. El implante se podía hacer más duro aumentando la cantidad de alginato sódico en solución, disminuyendo la cantidad de sal o disminuyendo el tamaño de los gránulos de sal.
Aunque se han ilustrado una o más formas concretas de la invención y se describen en el presente documento en el contexto de un implante, en particular un implante de mama para usar tras una tumorectomía, será evidente que el implante que tiene las características de la invención puede encontrar utilidad en diversas ubicaciones y en varias aplicaciones en las que se ha extirpado tejido. En consecuencia, no se pretende que la invención esté limitada a las formas de realización específicas ilustradas. Por tanto, se pretende que la presente invención se defina mediante el alcance de las reivindicaciones adjuntas. Además, los expertos en la técnica reconocerán que las características mostradas en una forma de realización se pueden usar en otras formas de realización.
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Claims (8)

  1. REIVINDICACIONES
    1. Un implante para implantación en una cavidad corporal y para el recrecimiento de tejido antes de que se produzca una bioabsorción significativa del implante, comprendiendo el implante un cuerpo poroso formado por un material
    5 bioabsorbible con poros en la superficie de entre 20 y 80 µm de tamaño y poros interiores de entre 50 y 200 µm de tamaño, un agente de obtención de imágenes radioopaco que facilite la obtención de imágenes de los márgenes exteriores del implante y un marcador de orientación interior separado hacia el interior de los márgenes exteriores del implante para facilitar la orientación relativa entre el implante y una fuente de radiación, caracterizado por que el material bioabsorbible comprende al menos en parte un chitosano o alginato bioabsorbible.
    10 2. El implante de la reivindicación 1, en el que el marcador de orientación comprende una pluralidad de elementos radioopacos.
  2. 3. El implante de la reivindicación 1, en el que el material bioabsorbible incluye un material seleccionado del grupo que consiste en ácido poliláctico, ácido poliglicólico, copolímeros de ácido poliláctico y ácido poliglicólico, gelatina reticulada y uno o más polisacáridos seleccionados del grupo que consiste en dextrano y almidón.
    15 4. El implante de la reivindicación 1, en el que el agente de obtención de imágenes radioopaco es seleccionado del grupo que consiste en sulfato de bario, carbonato de bario, cloruro de plata, yoduro de plata, nitrado de plata, carbonato cálcico y óxido de cinc.
  3. 5. El implante de la reivindicación 2, en el que la pluralidad de elementos radioopacos comprenden un material
    metálico seleccionado del grupo que consiste en titanio, platino, oro, iridio, tántalo, tungsteno, plata, renio y acero 20 inoxidable no magnético.
  4. 6.
    El implante de la reivindicación 1 que tiene una dimensión transversal máxima entre 0,5 y 8 cm.
  5. 7.
    El implante de la reivindicación 1 que tiene una dimensión transversal máxima entre 2 y 6 cm.
  6. 8.
    El implante de la reivindicación 2, en el que la pluralidad de elementos radioopacos forma un plano en el interior del implante.
    25 9. El implante de la reivindicación 2, en el que el implante tiene tres elementos radioopacos que están localizados en los vértices de un triángulo equilátero.
  7. 10.
    El implante de la reivindicación 1, en el que el material bioabsorbible es un alginato cálcico.
  8. 11.
    El implante de la reivindicación 1, en el que el marcador de orientación es un RFID energizable externamente.
    6
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US19289608P 2008-09-23 2008-09-23
US12/586,449 US9327061B2 (en) 2008-09-23 2009-09-21 Porous bioabsorbable implant
US586449 2009-09-21
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BRPI0919822B1 (pt) 2018-09-04
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US20210023278A1 (en) 2021-01-28
WO2010039184A3 (en) 2010-11-18
CA2734239A1 (en) 2010-04-08
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US20120277859A1 (en) 2012-11-01
US9327061B2 (en) 2016-05-03
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US11833275B2 (en) 2023-12-05
US20140239528A1 (en) 2014-08-28
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US10786604B2 (en) 2020-09-29
JP6030166B2 (ja) 2016-11-24
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