ES2218953T5 - Stent que permite la administración local de rapamicina. - Google Patents
Stent que permite la administración local de rapamicina. Download PDFInfo
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- ES2218953T5 ES2218953T5 ES99302918T ES99302918T ES2218953T5 ES 2218953 T5 ES2218953 T5 ES 2218953T5 ES 99302918 T ES99302918 T ES 99302918T ES 99302918 T ES99302918 T ES 99302918T ES 2218953 T5 ES2218953 T5 ES 2218953T5
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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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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- 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
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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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- 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
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- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
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- 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
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- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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Abstract
SE DESCRIBE UN PROCEDIMIENTO DE ADMINISTRACION LOCAL DE RAPAMICINA, PARTICULARMENTE DESDE UN STENT INTRAVASCULAR, DIRECTAMENTE DESDE LOS MICROPOROS EN EL CUERPO DEL STENT O MEZCLADO O UNIDO AL REVESTIMIENTO DE POLIMERO APLICADO AL STENT, PARA INHIBIR LA PROLIFERACION DEL TEJIDO NEOINTIMO Y PARA EVITAR DE ESTA FORMA LA RESTENOSIS. LA INVENCION TAMBIEN FACILITA LAS CARACTERISTICAS DEL STENT PARA INHIBIR LA RESTENOSIS.
Description
La administración de rapamicina localmente, particularmente a partir de un stent, directamente a partir de microporos en el cuerpo del stent o mezclado o unido a un recubrimiento de polímero aplicado al stent, para inhibir la proliferación de tejidos neoíntimos en el stent, previene la reestenosis.
De acuerdo con la reivindicación 1, la invención también facilita el funcionamiento del stent para inhibir la reestenosis.
El reestrechamiento (reestenosis) de una arteria coronaria aterosclerótica después de una angioplastia coronaria transluminar percutánea (PTCA) se produce en el 10-50% de los pacientes que sufren este procedimiento y posteriormente requiere, ya sea una angioplastia adicional o un injerto de derivación de arteria coronaria. Aunque los procesos exactos hormonales y celulares que promueven la reestenosis todavía están siendo determinados, el entendimiento actual es que el proceso de PTCA, además de abrir la arteria obstruida ateroescleróticamente, también daña las células de músculo liso arterial coronario residentes (SMC). Como respuesta a este daño, las plaquetas adherentes, macrófagos de infiltración, leucocitos o las mismas células de músculo liso (SMC) liberan factores de crecimiento derivados de células con la proliferación subsiguiente y la migración de SMC mediales a través de la lámina elástica interna, al área íntima del vaso. La proliferación adicional y la hiperplasia de las SMC íntimas, y más significativamente, la producción de grandes cantidades de matrices extracelulares en un periodo de 3 -6 meses produce el llenado y el estrechamiento del espacio vascular, lo suficiente para obstruir de manera significativa el flujo de sangre coronaria.
Varios enfoques experimentales recientes para impedir la proliferación de SMC se han mostrado prometedores, aunque todavía no está claro el mecanismo de la mayor parte de los agentes que se utilizan. La heparina es el agente mejor conocido y caracterizado, que produce la inhibición de la proliferación de SMC, in vitro y en modelos de animales de daños producidos por angioplastia de balón. El mecanismo de la inhibición de SMC con heparina todavía no se conoce, pero puede ser debido a cualquiera o a todos los siguientes factores: 1) expresión reducida de los protooncogenes regulatorios de crecimiento c-fos y c-mic, 2) producción celular reducida del activador de plasminógeno de tejido; y 3) sujeción y secuestro de los factores regulatorios de crecimiento, tales como el factor de crecimiento fibrovalente (FGF).
Otros agentes que han demostrado la capacidad para reducir el engrosamiento mioíntimo en modelos animales de daños vasculares por balón son la angiopeptina (un análogo a la somatostatina), bloqueadores de canal de calcio, inhibidores de enzima de conversión a angiotensina (captopril, cilazapril), ciclosporina A, trapidil (un agente antiplaqueta, antiangina) terbinafina (antifúngico), colchicina y taxol (antiproliferantes de antitubulina) y oligonucleótidos antisentido c-myc y c-mib.
Adicionalmente, un anticuerpo de cabra para el factor de crecimiento mitogénico derivado de plaquetas (PDGF) de las SMC ha mostrado su efectividad para reducir el engrosamiento mioíntimo en modelo de ratas con daños angioplásticos por balón, con lo cual implica directamente al PDGF en la etiología de la reestenosis. Por lo tanto, aunque todavía ninguna terapia ha probado tener éxito clínicamente para prevenir la reestenosis después de la angioplastia, el éxito experimental in vivo de varios agentes que se sabe que inhiben el crecimiento SMC sugiere que estos agentes, como clase, tienen la capacidad de impedir la reestenosis clínica y merecen una evaluación cuidadosa en los seres humanos.
La enfermedad cardiaca coronaria es la principal causa de muerte en los hombres mayores de 40 años y en las mujeres mayores de 50 años en el mundo occidental. La mayor parte de las muertes relacionadas con las arterias coronarias son debidas a la aterosclerosis. Las lesiones ateroscleróticas que limitan y obstruyen el flujo de sangre coronaria son la principal causa de la enfermedad coronaria isquémica relacionada con la mortalidad y producen
500.000 – 600.000 muertes anualmente en los EE.UU. Para parar el proceso de la enfermedad e impedir estados de enfermedad mas avanzados en los cuales el mismo músculo cardiaco se encuentre comprometido, se ha utilizado la intervención directa por medio de angioplastia coronaria transluminar percutánea (PTCA) o injertos de derivación arterial coronaria (CABG).
La PTCA es un procedimiento en el cual se pasa un catéter con un pequeño balón en la punta hacia abajo por una arteria coronaria estrechada y a continuación, se expande para volver a abrir la arteria. Se efectúa actualmente aproximadamente en 250.000 – 300.000 pacientes cada año. La ventaja principal de esta terapia es que los pacientes en los cuales el procedimiento tiene éxito no tienen que sufrir el procedimiento quirúrgico más invasivo del injerto de derivación de arteria coronaria. Una dificultad principal con la PTCA es el problema del cierre post-angioplástico del vaso, tanto inmediatamente después de la PTCA (reoclusión aguda) como a largo plazo (reestenosis).
El mecanismo de reoclusión aguda parece ser que incluye varios factores y puede resultar de un re-enrollamiento vascular con el cierre resultante de la arteria y/o la deposición de plaquetas sanguíneas a lo largo de la longitud dañada del vaso sanguíneo que se acaba de abrir, seguido por la formación de trombos de fibrina / células sanguíneas rojas. Recientemente, se han examinado los stent intravasculares como medio para prevenir el re-cierre agudo después de la PTCA.
La reestenosis (re-cierre crónico) después de la angioplastia es un proceso más gradual que la reoclusión aguda: el 30% de los paciente con lesiones subtotales y 50% de los paciente con lesiones totales crónicas tendrán reestenosis después de la angioplastia. Aunque el mecanismo exacto de la reestenosis todavía se encuentra bajo investigación activa, los aspectos generales del proceso de la reestenosis han sido identificados:
En la pared arterial normal, las células de músculos lisos (SMC) proliferan con una velocidad baja (<0.1% /día; ref). Las SMC en las paredes del recipiente del vaso existen en un fenotipo “contráctil” que se caracteriza porque un 80%-90% del volumen citoplásmico de la célula está ocupado por el aparto contráctil. Los retículos endoplásmicos, cuerpos de Golgi y ribosomas libres son pocos y están situados en la región perinuclear. La matriz extracelular rodea las SMC y es rica en gliclosilaminoglicanos similares a la heparina, los cuales se cree que son los responsables de mantener las SMC en el estado fenotípico contráctil.
Debido la expansión por presión de un catéter de balón intracoronario durante la angioplastia, se dañan las células de músculos lisos en el interior de la pared arterial. Los factores de crecimiento derivados de las células, tales como el factor de crecimiento derivado de las plaquetas (PDGF), el factor de crecimiento fibroblástico básico (bFGF), el factor de crecimiento epidérmico (EGF), etc., liberados por las plaquetas (es decir, PDGF) adheridas a la superficie luminal arterial dañada, los macrófagos invasores y/o leucocitos, o directamente desde las SMC (es decir, BFGF), provocan una proliferación y respuesta migratoria en las SMC mediales. Estas células sufren un cambio fenotípico desde el fenotipo contráctil a un fenotipo “sintético” que se caracteriza por solamente unos pocos haces de filamento contráctil, pero un retículo endoplásmico rugoso extenso, Golgi y ribosomas libres. La proliferación / migración se inicia normalmente 1-2 días después del daño y alcanza un pico a los 2 días de media, declinando a continuación rápidamente (Campbell et al., In: Vascular Smooth Muscle Cells in Culture, Campbell, J.H. y Campbell, G.R., Eds, CRC Press, Boca Ration, 1987, pág. 39-55); Clowes, A.W. y Schwartz, S.M., Circ. Res. 56; 139 –145, 1985)
Finalmente, las células sintéticas hijas migran a la capa íntima del músculo liso arterial y continúan su proliferación. La proliferación y la migración continúan hasta que la capa endotelial luminal dañada se regenera y en dicho momento cesa la proliferación de la íntima, normalmente 7-14 días después del daño. El incremento remanente en el engrosamiento íntimo que se produce en los siguientes 3-6 meses es debido a un incremento en la matriz extracelular, en lugar de serlo por el número de células. Por lo tanto, la migración SMC y la proliferación es una respuesta aguda a un daño de un vaso mientras que la hiperplasia íntima es una respuesta más crónica.
Los pacientes con reoclusión sintomática requieren repetir la PTCA o bien, CABG. Debido a que el 30-50% de los pacientes que sufren PTCA experimentarán reestenosis, la reestenosis ha limitado claramente el éxito de la PTCA como solución terapéutica a la enfermedad arterial coronaria. Debido a que la proliferación de SMC y la emigración están íntimamente involucradas con la respuesta patofisiológica al daño arterial, la prevención de la proliferación y emigración de SMC representan un objetivo para la intervención farmacológica en la prevención de la reestenosis.
Sumario de la invención
En la actualidad, los intentos para mejorar la eficiencia clínica de los stent han implicado alguna variación, ya sea en la aplicación de un recubrimiento al metal, en la unión de una cubierta o membrana, o en la incrustación de material en la superficie por medio de un bombardeo de iones. Un stent diseñado para que incluya depósitos de acuerdo con la reivindicación 1, es una nueva solución que ofrece varias ventajas importantes con respecto a las tecnologías existentes.
En esta aplicación, se desea administrar un agente terapéutico al lugar del daño arterial. La solución convencional ha sido incorporar el agente terapéutico en un material polímero el cual, a continuación, se recubre sobre el stent. El material de recubrimiento ideal debe poder adherirse fuertemente al stent metálico, tanto antes como después de la expansión, debe poder retener el fármaco con un nivel de carga suficiente para obtener la dosis requerida, debe poder liberar el fármaco de una manera controlada durante un periodo de varias semanas, y debe ser lo más delgado posible para minimizar el incremento del perfil. Además, el material de recubrimiento no debe contribuir a ninguna respuesta adversa del cuerpo (es decir, debe ser no trombogénico, no inflamatorio, etc.) Hasta la fecha, no se ha desarrollado el material de recubrimiento ideal para esta aplicación.
Una alternativa sería diseñar el stent para que contuviese depósitos que estén cargados con el fármaco. Aunque no sea de acuerdo con la invención, se podría aplicar un recubrimiento o membrana de material biocompatible sobre los depósitos, lo cual controlaría la difusión del fármaco desde los depósitos hasta la pared de la arteria.
Una ventaja de este sistema es que las propiedades del recubrimiento se pueden optimizar para alcanzar propiedades de biocompatibilidad y de adherencia superiores, sin el requisito adicional de poder cargar y liberar el fármaco. Se puede utilizar el tamaño, forma, posición y número de depósitos para controlar la cantidad de fármaco y por lo tanto, la dosis suministrada.
La invención se comprenderá mejor con referencia a las figuras que siguen, en las cuales las figuras 1 y 1A son vistas superiores y vistas en sección de un stent que contiene depósitos, como se describe en la siguiente invención;
Las figuras 2a y 2b son vistas similares de una realización alternativa del stent con extremos abiertos;
Las figuras 3a y 3b son figuras alternativas adicionales de un dispositivo que contienen un depósito ranurado; y
La figura 4 es una vista de composición de un dispositivo que contiene un depósito como en la figura 3.
Los intentos farmacológicos para prevenir la reestenosis por medios farmacológicos hasta el momento no han tenido éxito y todos incluyen la administración sistemática de agentes de prueba. Ni la aspirina-dipiridamol, ticlopidina, administración aguda de heparina, warfarina crónica (6 meses) ni la metilprednisolona han sido efectivos para prevenir la reestenosis aunque algunos inhibidores de plaquetas han sido efectivos para prevenir la reoclusión aguda después de la angioplastia. Los antagonistas de calcio tampoco han tenido éxito para prevenir la reestenosis, aunque todavía se encuentran bajo estudio. Otros agentes que actualmente se encuentran bajo estudio incluyen los inhibidores de tromboxano, miméticos de la prostaciclina, bloqueantes de receptor de membrana de plaqueta, inhibidores de trombina e inhibidores de enzimas de conversión de angiotensina. Sin embargo, esos agentes deben suministrarse sistemáticamente, y puede que no sea posible alcanzar dosis terapéuticamente efectivas; las concentraciones de antiproliferantes (o anti–reestenosis) pueden superar las concentraciones tóxicas conocidas de estos agentes, de manera que es posible que no se puedan alcanzar los niveles suficientes para producir la inhibición de músculos lisos (Lang et al., Ann. Rev. Med., 127-132 (1991); Popma et al., 84 Circulation, 1426 – 1436 (1991).
Las pruebas clínicas adicionales en las que se ha examinado la efectividad de suplementos de la dieta de aceite de pescado, antagonistas de receptores tromboxano, agentes de disminución del colesterol y antagonistas de la serotonina para impedir la reestenosis, han mostrado resultados conflictivos o negativos, de manera que todavía no hay agentes farmacológicos clínicamente disponibles para impedir la reestenosis post angioplastia (Franklin, S.M. y Faxon, D.P., 4 Coronary Artery disease, 232 – 242 (1993); Serruys, P. W et al., 88 Circulation (parte 1) 1588 – 1601, (1993).
Por otro lado, los stent han probado su utilidad para prevenir la reducción de la proliferación de reestenosis. Los stent, tales como el stent 10 cuya composición se ve en la figura 4, tubos metálicos ranurados con balones expansibles (normalmente de acero inoxidable, pero sin limitación), que cuando se expanden en el interior del lúmen de la arteria coronaria que ha sufrido angioplastia proporcionan un soporte estructural a la pared arterial. Este soporte es útil para mantener una trayectoria abierta para el flujo sanguíneo. En dos pruebas clínicas aleatorias, los stent mostraron que incrementaban el éxito angiográfico después de la PTCA, incrementan el lúmen del vaso sanguíneo con estenosis y producen la reducción de la recurrencia de lesiones a los 6 meses (Serruys et al., 331 New Eng Tour. Med. 495, (1994); Fischman et al., 331 New Eng Tour. Med 496 – 501 (1994). Adicionalmente, en una prueba preliminar, los stent recubiertos con heparina parecen producir los mismos beneficios de reducción en el diámetro de la estenosis en los seguimientos que los que se observaron con stent recubiertos con material que no era heparina. Adicionalmente, el recubrimiento con heparina parece tener el beneficio añadido de producir una reducción en la trombosis subaguda después de la implantación del stent (Serruys et al., 93 Circulation, 412 – 422, (1996). Por lo tanto, 1) la expansión mecánica sostenida de una arteria coronaria con estenosis ha mostrado que proporciona alguna medida de prevención de la reestenosis, y 2) el recubrimiento de los stent con heparina ha demostrado la capacidad así como la utilidad clínica de administrar medicamentos a tejidos dañados locales desde la superficie del stent.
Se están estudiando activamente numerosos agentes como agentes antiproliferantes para su utilización en la reestenosis y se conoce alguna actividad en modelos experimentales con animales. Estos incluyen: heparina y fragmentos de heparina (Clowes y Karnovsky, 265 Nature, 25 – 626, (1977); Guyton, J.R. et al., 46 Circ. Res., 625 – 634, (1980); Clowes, A.W. y Clowes M.M., 52 Lab. Invest., 611-616, (1985); Clowes, A.W. y Clowes, M.M., 58 Circ. Res., 839-845 (1986); Majesky et al., 61 Circ Res., 296-300, (1987); Snow et al., 131 Am. J. Pathol., 313-330 (1990); Okada, T. et al., 25 Neurosurgery,-92-898, (1989) colchicina (Currier, J.W. et al., 80 Circulation, 11-66, (1989), taxol (ref), inhibidores de enzimas de conversión de agiotensina (ACE) (Powell, J.S. et al., 245 Science, 186-1B8 (1989), angiopeptina (Lundergan, C.F. et al., 17 Am. J. Cardiol. (Suppl. B); 132B-136B (1991), ciclosporina A (Jonasson, L. et. al., 85 Proc. Nati, Acad. Sci., 2303 (198B), anticuerpos PDGF de cabra – anti –conejo (Ferns, G.A.A., et al., 253 Science, 1129-1132 (1991), terbinafine (Nemecek, G.M. et al., 24B J. Pharmacol. Exp. Thera., 1167-11747 (1989), trapidil (Liu, M.W. et al., B1 Circulation, 1089-1093 (1990), interferon-gamma (Hansson, G.K. y Holm, 84 J. Circulation, 1266-1272 (1991), esteroides (Colburn, M.D. et al., 15 J. Vasc. Surg., 510-51B (1992), ver también Berk, B.C. et al., 11 J. Am. Coll. Cardiol., lllB-1 17B (1991), radiación ionizante (ref), toxinas de fusion (ref) oligonucleótidos antisentido (ref), vectores de genes (ref), y rapamicina (véase más abajo).
De interés particular es la rapamicina. La rapamicina es un antibiótico macrólido que bloquea la proliferación de células T mediada por IL-2 y posee actividad antiinflamatoria. Aunque el mecanismo preciso de la rapamicina todav
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ía se encuentra bajo investigación activa, la rapamicina ha demostrado que impide la progresión de la fase G a la S de las células T en el ciclo celular inhibiendo las ciclinas celulares específicas y las proteínas cinasas dependientes de ciclina (Siekierka, immuno. Res. 13: 110 – 116 (1994). La acción antiproliferante de la rapamicina no está limitada a las células T; Marx et al., (Circ. Res 76:412 – 417, 1995) han demostrado que la rapamicina previene la proliferación de SMC de ratas así como de seres humanos in vitro mientras que Poon et al., han demostrado que la migración de SMC de ratas, cerdos y seres humanos también puede inhibirse por la rapamicina (J Clin Invest 98: 2277 – 2283, 1996). Por lo tanto, la rapamicina puede inhibir la respuesta inflamatoria que se sabe que se produce después del daño arterial y de la implantación del stent, así como la respuesta hiperproliferativa de SMC. De hecho, los efectos combinados de la rapamicina han demostrado que producen una respuesta hiperproliferativa de SMC disminuida en un modelo de injerto arterial femoral en ratas y en los modelos de daño por balón arterial en ratas y cerdos (Gregory et al., Transplantation 55: 1409 – 1418, 1993; Gallo et al., en prensa, (1997). Estas observaciones claramente apoyan el uso potencial de la rapamicina en el establecimiento clínico de la reestenosis post – angioplástica.
Aunque el agente ideal para la reestenosis todavía no ha sido identificado, algunas propiedades deseadas son claras: inhibición de trombosis local sin el riesgo de complicaciones de hemorragias sistémicas y continuas y prevención del daño arterial, incluyendo inflamación local y prevención sostenida de la proliferación de músculos lisos en el lugar de la angioplastia sin complicaciones sistemáticas serias. Dado que los stent impidan al menos una porción del proceso de reestenosis, un agente que impide la inflamación y la proliferación de SMC combinado con un stent puede proporcionar el tratamiento mas eficaz para la reestenosis post-angioplástica.
Agentes: análogos estructurales de la Rapamicina (sirolimus) (lactonas macrocíclicas) e inhibidores de la progresión del ciclo celular.
Estos pueden variar:
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- suministro local de tales agentes (rapamicina) a partir de los tirantes de un stent, a partir un injerto de stent, injertos, cubierta de stent o recubrimiento.
- •
- implicar la mezcla conjunta con polímeros (degradables así como no degradables) para mantener el fármaco en el stent o injerto.
• o atrapar el médicamente en el metal del stent o cuerpo de implante que ha sido modificado para contener microporos o canales, como se explicará adicionalmente más adelante.
• o incluir uniones covalentes del fármaco con el stent por medio de técnicas químicas de disolución (tales como
por medio del proceso Carmeda) o técnicas de química seca (por ejemplo, métodos de deposición de vapor ta
les como polimerización de plasma rf) y combinaciones de las mismas.
- •
- aplicación de catéter intravascularmente desde un balón en tándem o un balón poroso para la absorción intramural.
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- aplicación extravascular por la ruta pericardial.
- •
- aplicación extravascular por aplicación de formulaciones de liberación sostenidas.
Usos: para inhibir la proliferación de células e impedir la proliferación neoíntima y la reestenosis.
impedir la expansión de tumores a partir de los stent
impedir el crecimiento de tejidos dentro de los catéteres y los shunt que inducen sus fallos.
La solución de rapamicina, preparada en un disolvente miscible con solución portadora polímera, se mezcla con una solución del polímero con un rango de concentración final del 0,001% en peso al 30% en peso del fármaco. Los polímeros son biocompatibles (es decir, no provocan ninguna reacción de tejido negativa ni promueven la formación de trombos murales) y son degradables, tal como los poliésteres o copoliésteres basados en lactonas, por ejemplo, polilactida, policaprolactona – glicólido, poliortoésteres, polianhídridos; poliaminoácidos; polisacáridos; polifosfacenos; poli (éter – éster); copolímeros; por ejemplo, PEO –PLLA o mezclas de los mismos. Los polímeros biocompatibles no absorbibles también son candidatos adecuados. Polímeros tales como el polidimetilsiloxano; poli(etileno – vingilacetato); polímeros o copolímeros basados en acrilato, por ejemplo, poli(hidroexietil metilmetacrilato, pirrolidinona de polivinilo; polímeros fluorados tales como el politetrafluoretileno; ésteres de celulosa.
La mezcla de polímeros / fármaco se aplica a las superficies del stent, ya sea por recubrimiento por inmersión, o recubrimiento por pulverización, o recubrimiento por cepillado o recubrimiento por inmersión / centrifugado, o sus combinaciones, y se permite que el disolvente se evapore dejando una película con la rapamicina atrapada.
El stent, cuyo cuerpo se ha modificado para que contenga microporos o canales, se sumerge en una solución de rapamicina, en un rango del 0,001% en peso a saturado, en un disolvente orgánico tal como la acetona o el cloruro de metileno, durante un tiempo suficiente que permita que la solución permee dentro de los poros. (La solución de inmersión también se puede comprimir para mejorar la eficiencia de carga). Después de que se haya permitido que el disolvente se evapore, el stent se sumerge brevemente en disolvente nuevo para eliminar el exceso de fármaco unido a la superficie. Una disolución de polímero, elegida entre cualquiera de las identificadas en el primer método experimental, se aplica al stent como se ha detallado más arriba. Esta capa exterior de polímero actuará como un controlador de difusión para la liberación del fármaco.
Se modifica la rapamicina para que contenga una unión covalente enzimática o hidrolíticamente lábil para su unión a la superficie del stent, que en sí mismo ha sido derivado químicamente para permitir la inmovilización covalente. Las uniones covalentes tales como éster, amidas o anhídridos pueden ser adecuados para esto.
A: Lámina polimérica: se combina la rapamicina a un rango de concentración como previamente se ha indicado, con un polímero degradable tal como poli(caprolactona – glicólido) o un polímero no degradable, por ejemplo, polidimetilsiloxano y la mezcla se funde como una lámina delgada, con un rango de espesor de 10 micras a 1000 micras. La lámina resultante se puede enrollar perivascularmente sobre el vaso objetivo. Se debe dar preferencia al polímero absorbible.
B: Recubrimiento de conformación La rapamicina se combina con un polímero que tenga una temperatura de fusión justamente por encima de 37º C, en el rango de 40º-45º C. Se aplica la mezcla en estado fundido al lado externo del vaso objetivo. Después de que se enfríe a la temperatura corporal, la mezcla se solidifica conformándose a la pared del vaso. Son adecuados los polímeros biocompatibles no degradables así como los absorbibles.
Como se aprecia en las figuras, también es posible modificar los stent actualmente fabricados con el fin de proporcionar adecuadamente las dosis de fármaco tales como la rapamicina. Como se puede apreciar en las figuras 1a, 2a y 3a, cualquier tirante 10, 20, 30 de stent se puede modificar para que tenga un cierto depósito o canal 11, 21, 31. Cada uno de estos depósitos es abierto. Estos depósitos pueden mantener el fármaco que se va a suministrar. La figura 4 muestra un stent 40 con un depósito 45 creado en el vértice de un tirante flexible. Por supuesto, se pretende que este depósito 45 sea útil para suministrar rapamicina o cualquier otro fármaco en un punto específico de flexibilidad del stent. De acuerdo con lo anterior, este concepto puede ser útil para stent del tipo de “segunda generación”.
Sin embargo, en cualquiera de los dispositivos anteriores es útil que la dosis de fármaco se aplique con una especificidad suficiente y concentración suficiente para proporcionar una dosis efectiva en el área de la lesión. En lo que a esto se refiere, se debe mantener el tamaño de depósito en los tirantes del stent de un tamaño de aproximadamente 1,27.10–5 m (0,0005’’) a aproximadamente 7,62.10-5 m (0,003’’). A continuación, sería posible aplicar de manera adecuada la dosis de fármaco en la posición deseada y en la cantidad deseada.
Estos y otros conceptos se han mostrado en la presente memoria. Será aparente al lector que son posibles modificaciones en el stent o en la dosis de fármaco aplicada. Sin embargo, en cualquier caso cualquier modificación obvia debe percibirse como que se encuentra dentro del alcance de la invención que debe hacerse patente a partir de las reivindicaciones anexas
Claims (6)
- REIVINDICACIONES1. Un stent que comprende:un cilindro de pared generalmente delgada, conteniendo el citado cilindro una pluralidad de tirantes (10, 20, 30), siendo expansibles los citados tirantes dependiendo de la cantidad de fuerza aplicada al citado tirante,5 y teniendo los citados tirantes un espesor generalmente uniforme; y un canal (11, 21, 31) formado en el al menos uno de los citados tirantes, teniendo el citado canal un perímetro cerrado en tres lados y una parte superior abierta, y siendo el citado canal menor en todas las dimensiones que el citado tirante, conteniendo el citado canal un agente terapéutico que se encuentra aplicado al mismo.
- 2. Un stent de acuerdo con la reivindicación 1, en el que el citado canal tiene un perímetro generalmente rectangu10 lar.
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- 3.
- Un stent de acuerdo con la reivindicación 2, en el que el citado agente terapéutico es rapamicina con la que se ha recubierto el citado canal.
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- 4.
- El stent de la reivindicación 3, en la que el citado canal es de forma rectangular.
-
- 5.
- El stent de la reivindicación 3, que contiene tirantes con los citados canales.
15 6. El stent de la reivindicación 1, en el que el agente terapéutico es rapamicina. - 7. Un stent que comprende una estructura con paredes generalmente delgadas que contienen una pluralidad de tirantes (10, 20, 30), siendo expansibles los tirantes para asumir la forma de un lúmen dentro del cual se coloca el stent, teniendo los citados tirantes un espesor, y un canal (11, 21, 31) formado en al menos uno de los citados tirantes, teniendo el citado canal un perímetro cerrado en tres lados y una parte superior abierta, y20 siendo el citado canal menor en todas las dimensiones que el citado tirante, conteniendo el citado canal un agente terapéutico aplicado en su interior.
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-
1998
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-
1999
- 1999-04-15 EP EP20030078948 patent/EP1407726A1/en not_active Ceased
- 1999-04-15 AT AT99302918T patent/ATE263520T1/de active
- 1999-04-15 DE DE69916157T patent/DE69916157T3/de not_active Expired - Lifetime
- 1999-04-15 EP EP99302918A patent/EP0950386B2/en not_active Expired - Lifetime
- 1999-04-15 ES ES99302918T patent/ES2218953T5/es not_active Expired - Lifetime
- 1999-04-15 PT PT99302918T patent/PT950386E/pt unknown
- 1999-04-16 CA CA002639396A patent/CA2639396A1/en not_active Abandoned
- 1999-04-16 CA CA002269310A patent/CA2269310A1/en not_active Abandoned
- 1999-04-16 CA CA002639393A patent/CA2639393A1/en not_active Abandoned
-
2001
- 2001-06-04 US US09/874,117 patent/US6585764B2/en not_active Expired - Lifetime
-
2003
- 2003-04-07 US US10/408,328 patent/US6808536B2/en not_active Expired - Lifetime
-
2004
- 2004-09-28 US US10/951,385 patent/US7223286B2/en not_active Expired - Lifetime
-
2006
- 2006-08-24 US US11/467,035 patent/US7217286B2/en not_active Expired - Lifetime
- 2006-08-24 US US11/466,983 patent/US7229473B2/en not_active Expired - Lifetime
- 2006-11-01 US US11/555,420 patent/US7666222B2/en not_active Expired - Lifetime
-
2008
- 2008-09-05 US US12/204,987 patent/US20080317827A1/en not_active Abandoned
-
2010
- 2010-06-02 US US12/792,114 patent/US20100239636A1/en not_active Abandoned
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EP0950386A3 (en) | 2000-04-05 |
US7229473B2 (en) | 2007-06-12 |
US20080317827A1 (en) | 2008-12-25 |
US20060282160A1 (en) | 2006-12-14 |
US6585764B2 (en) | 2003-07-01 |
EP0950386B1 (en) | 2004-04-07 |
ATE263520T1 (de) | 2004-04-15 |
US20050085902A1 (en) | 2005-04-21 |
US7223286B2 (en) | 2007-05-29 |
US20070021825A1 (en) | 2007-01-25 |
PT950386E (pt) | 2004-08-31 |
DE69916157T2 (de) | 2005-03-17 |
US6273913B1 (en) | 2001-08-14 |
EP0950386A2 (en) | 1999-10-20 |
US20010027340A1 (en) | 2001-10-04 |
CA2639393A1 (en) | 1999-10-16 |
DE69916157D1 (de) | 2004-05-13 |
ES2218953T3 (es) | 2004-11-16 |
EP1407726A1 (en) | 2004-04-14 |
US20030176915A1 (en) | 2003-09-18 |
US7666222B2 (en) | 2010-02-23 |
CA2269310A1 (en) | 1999-10-16 |
EP0950386B2 (en) | 2011-07-13 |
DE69916157T3 (de) | 2012-02-23 |
US20070100436A1 (en) | 2007-05-03 |
US6808536B2 (en) | 2004-10-26 |
CA2639396A1 (en) | 1999-10-16 |
US7217286B2 (en) | 2007-05-15 |
US20100239636A1 (en) | 2010-09-23 |
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