ES2218953T3 - Stent que permite la administracion local de rapamicina. - Google Patents
Stent que permite la administracion local de rapamicina.Info
- Publication number
- ES2218953T3 ES2218953T3 ES99302918T ES99302918T ES2218953T3 ES 2218953 T3 ES2218953 T3 ES 2218953T3 ES 99302918 T ES99302918 T ES 99302918T ES 99302918 T ES99302918 T ES 99302918T ES 2218953 T3 ES2218953 T3 ES 2218953T3
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- stent
- channel
- rapamycin
- restenosis
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- Expired - Lifetime
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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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- 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
-
- A—HUMAN NECESSITIES
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- 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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- 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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- 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
- 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
- A61F2002/91541—Adjacent bands are arranged out of phase
-
- 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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- 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
- A61F2002/9155—Adjacent bands being connected to each other
- A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
- A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Surgery (AREA)
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- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Prostheses (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
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
Stent que permite la administración local de
rapamicina.
La administración de rapamicina localmente,
particularmente de un stent, directamente de microporos en el
cuerpo del stent o mezclado o unido a un recubrimiento 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 arteroesclerótica 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 artero escleróticamente, 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 inmigración 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 prometedoras,
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 plasminogen 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 grosor mioíntimo en modelos animales de daños
vasculares por balón son la angiopectina (un análogo a la
somatostatina), inhibidores de canal de calcio, inhibidores de
encima de conversión a angiotensina (captopril, cilazapril,),
ciclosporina A, trapidil (un agente antiplaqueta, antiangina)
terbinafina (antihongo), colchicina y taxol (antiproliferantes de
antitubulina) y oligonucleótidos antisentido c-myc
y c-mib.
Adicionalmente, un anticuerpo de gota para el
factor de crecimiento derivado de plaquetas mitógenas SMC (PDGF) ha
mostrado su efectividad para reducir el grosor 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 conocidos 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 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 debida a la
ateroesclerosis. Las lesiones ateroescleróticas 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 en
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 mas invasivo del injerto de derivación de arteria
coronaria. Una dificultad principal con la PTCA es el problema del
cierre post-angioplástico del vaso, inmediatamente
después de la PTCA (reoclusión aguda) así como a largo término
(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 células sanguíneas fibrosas
/ 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
gliclosilaminglicanos similares a la heparina, los cuales se cree
que son los responsables de mantener las SMC en el estado
fenotípico contráctil.
Bajo expansión a 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 derivado 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), ect., liberados de las plaquetas (es decir, PDGF)
se adhieren 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 Raton, 1987, pag. 39-55);
Clowes, A.W. y Schwartz, S.M., Circ. Res. 56; 139 -145, 1985).
Finalmente, las células sintéticas hijas emigran
a la capa íntima del músculo liso arterial y continúan su
proliferación. La proliferación y la emigración 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 emigración SMC y la
proliferación es una respuesta aguda a un daño de un vaso mientras
que la hiperplasia íntima es un 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.
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, antes así como después de la
expansión, debe poder retener el fármaco con un nivel de carga
suficiente para obtener la dosis requerida, debe poder libera el
fármaco de una manera controlada en 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 se puedan cargar con el fármaco. 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 la disposición 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- dipiridamole, ticlopidina,
administración aguda de heparina, warfarina crónica (6 meses) ni el
metilprednisolone 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 y inhibidores de encimas de conversión de angiotensina.
Sin embargo, esos agentes deben suministrarse sistemáticamente, y
puede que no sea posible alcanzar dosis efectivas terapéuticas; las
concentraciones de antiproliferantes (o anti - reestenosis) pueden
superar las concentraciones tóxicas conocidas de estos agentes, de
manera 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 aceite de pescado
dietético, 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)
De manera consecuente, los stent han probado su
utilidad para prevenir la reducción de la proliferación de
reestenosis. Los stent, tales como el stent 10 cuya disposición se
ve en la figura 4, tubos metálicos ranurados con balones
expansibles (normalmente, pero no limitados al acero inoxidable),
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 en 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 han estudiado 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) colchicine (Currier,
J.W. et al., 80 Circulation, 11-66, (1989),
taxol (ref), inhibidores de encimas 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), Cyclosporin A (Jonasson, L. et.
al., 85 Proc. Nati, Acad. Sci., 2303 (198B), anticuerpos PDGF
de cabra - anti -conejo goat (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 que bloquea la proliferación de
células T mediadas con IL-2 y posee actividad
antiinflamatoria. Aunque el mecanismo preciso de la rapamicina
todavía se encuentra bajo investigación activa, la rapamicina ha
demostrado que impide la progresión de fase de G a S de las células
T en el ciclo celular inhibiendo las ciclinas celulares específicas
y las quinasas de proteína dependientes de la 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 migratina 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 de las 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
soportan 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 sistemáticas 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. Siempre cuando
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 estructuras de la
Rapamicina (sirolimus) (lactonas macrocíclicas) e inhibidores de la
progresión del ciclo celular.
Estos pueden variar:
- \bullet
- suministro local de tales agentes (rapamicina de los montantes de un stent, desde un injerto de stent, injertos, cubierta de stent o recubrimiento.
- \bullet
- implicar la mezcla conjunta con polímeros (degradables así como no degradables) para mantener el fármaco en el stent o injerto.
- \bullet
- 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.
- \bullet
- O incluir uniones covalentes del fármaco con el stent por medio de técnicas químicas de solución (tales como por medio del proceso Carmeda) o técnicas de química seca (por ejemplo, métodos de deposición de vapor tales como polimerización de plasma rf) y combinaciones de los mismos.
- \bullet
- aplicación de catéter intravascularmente desde un balón en tándem o de un balón poroso para la toma intramural.
- \bullet
- aplicación extravascular por ruta pericardial.
- \bullet
- 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 desde los
stent
impedir el crecimiento de tejidos en los
catéteres y los shunt que inducen sus fallos.
La solución de rapamicina, preparada en un
solvente 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
degradable, tal como los poliesteres en base a la lactosa o
copoliesteres, por ejemplo, polilatida, policaprolactona -
glicolido, poliortoesteres, polianidridos; poliaminoácidos;
polisacáridos; polifosfacenos; poli (eter - ester); copolímeros;
por ejemplo, PEO -PLLA o mezclas de los mismos. Los polímeros
biocompatibles no absorbibles también son candidatos adecuados.
Polímeros tales como el polidimetilsiolxano; polietileno -
vingilacetato; polímeros o copolímeros basados en acrilato, por
ejemplo, poli(hidroexietil metilmetacrilato, pirrolidinona
de polivinilo; polímeros fluorados tales como el
politetrafluoretileno; esteres 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 combinaciones de
ambos, y se permite que el solvente 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, para que se sature, en
un solvente 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 solvente se evapore, el stent se sumerge
brevemente en solvente nuevo para eliminar el exceso de fármaco
unido a la superficie. Una solución 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 labil enzimática o hidrolíticamente para su unión a
la superficie del stent, que en si mismo ha sido derivado
químicamente para permitir inmovilización covalente. Las uniones
covalentes tales como éster, amidas o anhidros pueden ser adecuados
para esto.
A: Lámina polimérica: se combina la
rapamicina con un rango de concentración como previamente se ha
indicado, con un polímero degradable tal como
poli(caprolactona - glicolido) o polímero no degradable, por
ejemplo, polidimetilsiloexano 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
absorbentes.
Como se aprecia en las figuras, también es
posible modificar los stent actualmente fabricadas 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 montante 10, 20, 30 de stent se puede modificar para que
tenga un cierto deposito o canal 11, 21, 31. Cada uno de estos
depósitos puede ser abierto o cerrado como se desee. Estos
depósitos pueden mantener el fármaco que se va a suministrar. La
figura 4 muestra un stent 40 con un deposito 45 creado en el
vértice de un montante flexible. Por supuesto, se pretende que este
deposito 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 deposito en los
montantes del stent de un tamaño de aproximadamente 1,27.10^{-5} m
a aproximadamente 7,62.10^{-5} m. 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
embrago, en cualquier caso cualquier modificación obvia debe
percibirse para que se encuentra en la amplitud de la invención que
se especifica en las reivindicaciones anexas y en sus
equivalentes.
Claims (8)
1. Un stent que comprende:
un cilindro de pared genéricamente delgada,
conteniendo el citado cilindro una pluralidad de montantes (10, 20,
30), siendo expansibles los citados montantes dependiendo de la
cantidad de fuerza aplicada al citado montante, y teniendo los
citados montantes un espesor generalmente uniforme; y un canal (11,
21, 31) formado en el al menos uno de los citados montantes,
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 montante, 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 genéricamente
rectangular.
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.
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
montantes con los citados canales.
6. El stent de la reivindicación 3, en el que el
citado canal está cortado por láser en el citado montante.
7. El stent de la reivindicación 1, en el que el
agente terapéutico es rapamicina.
8. Un stent que comprende una estructura con
paredes genéricamente delgadas que contienen una pluralidad de
montantes (10, 20, 30), siendo expansibles los montantes para
asumir la forma de un lúmen dentro del cual se coloca el stent,
teniendo los citados montantes un espesor, y un canal (11, 21, 31)
formado en al menos uno de los citados montantes, 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 montante, conteniendo el citado canal un
agente terapéutico aplicado en su interior.
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- 1999-04-15 EP EP99302918A patent/EP0950386B2/en not_active Expired - Lifetime
- 1999-04-15 AT AT99302918T patent/ATE263520T1/de active
- 1999-04-15 DE DE69916157T patent/DE69916157T3/de not_active Expired - Lifetime
- 1999-04-15 PT PT99302918T patent/PT950386E/pt unknown
- 1999-04-15 ES ES99302918T patent/ES2218953T5/es not_active Expired - Lifetime
- 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
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-
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
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-
2010
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US20010027340A1 (en) | 2001-10-04 |
US6808536B2 (en) | 2004-10-26 |
US20070100436A1 (en) | 2007-05-03 |
EP0950386B1 (en) | 2004-04-07 |
US20100239636A1 (en) | 2010-09-23 |
CA2639396A1 (en) | 1999-10-16 |
US6585764B2 (en) | 2003-07-01 |
PT950386E (pt) | 2004-08-31 |
US20080317827A1 (en) | 2008-12-25 |
US20030176915A1 (en) | 2003-09-18 |
ATE263520T1 (de) | 2004-04-15 |
DE69916157D1 (de) | 2004-05-13 |
ES2218953T5 (es) | 2011-11-08 |
CA2269310A1 (en) | 1999-10-16 |
EP0950386B2 (en) | 2011-07-13 |
EP0950386A2 (en) | 1999-10-20 |
US20060282160A1 (en) | 2006-12-14 |
EP0950386A3 (en) | 2000-04-05 |
DE69916157T2 (de) | 2005-03-17 |
EP1407726A1 (en) | 2004-04-14 |
US7223286B2 (en) | 2007-05-29 |
US20050085902A1 (en) | 2005-04-21 |
US20070021825A1 (en) | 2007-01-25 |
US7666222B2 (en) | 2010-02-23 |
DE69916157T3 (de) | 2012-02-23 |
US7217286B2 (en) | 2007-05-15 |
CA2639393A1 (en) | 1999-10-16 |
US6273913B1 (en) | 2001-08-14 |
US7229473B2 (en) | 2007-06-12 |
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