ES2251190T3 - Hidrogel para el tratamiento terapeutico de aneurismas. - Google Patents
Hidrogel para el tratamiento terapeutico de aneurismas.Info
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- ES2251190T3 ES2251190T3 ES99918935T ES99918935T ES2251190T3 ES 2251190 T3 ES2251190 T3 ES 2251190T3 ES 99918935 T ES99918935 T ES 99918935T ES 99918935 T ES99918935 T ES 99918935T ES 2251190 T3 ES2251190 T3 ES 2251190T3
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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Abstract
Un dispositivo para tratar un aneurisma, que tiene una porción abovedada y un cuello que se abre en un vaso parental, teniendo el dispositivo la combinación de una bobina vasooclusiva generadora de émbolo y un hidrogel, en el que la bobina vasooclusiva generadora de émbolo se introduce en el aneurisma para permitir la administración del hidrogel dentro de la porción abovedada del aneurisma y adyacente al cuello del aneurisma, conteniendo el hidrogel un material radio-opaco y un agente terapéutico que se libera desde el hidrogel en el aneurisma para promover el crecimiento celular a lo largo del cuello del aneurisma para cerrar el cuello del aneurisma.
Description
Hidrogel para el tratamiento terapéutico de
aneurismas.
Esta invención se refiere de forma genérica al
tratamiento de aneurismas vasculares, y más particularmente
concierne al uso de hidrogeles y bobinas vasooclusivas que se han
de usar en ocluir aneurismas y en la administración controlada de
fármacos para el tratamiento de aneurismas.
Los aneurismas se han tratado tradicionalmente
con clips colocados externamente, o internamente mediante balones
vasooclusivos desmontables o de un dispositivo vasooclusivo
generador de émbolo, tal como una o más bobinas vasooclusivas. La
administración de tales dispositivos vasooclusivos se puede realzar
por distintos medios, incluyendo mediante un catéter en el que el
dispositivo se empuja a través del catéter mediante un empujador
para desplegar el dispositivo. Los dispositivos vasooclusivos se
pueden producir de una manera tal que pasarán a través del lumen de
un catéter en una forma lineal y adoptarán una forma compleja, como
se formaron originalmente, después de que se hayan desplegados
dentro del área de interés, tal como un aneurisma. En las técnicas
actuales, los dispositivos vasooclusivos toman la forma de alambres
enrollados en espiral que pueden tomar formas tridimensionales más
complejas cuando se insertan en el área a tratar. Usando materiales
que son sumamente flexibles, o incluso súper elásticos y
relativamente pequeños en diámetro, los alambres se pueden instalar
en un micro catéter en una configuración relativamente lineal y
asumir una forma más compleja cuando se fuerza desde el extremo
alejado del catéter.
Los adhesivos que se han introducido para ayudar
a curar los aneurismas incluyen cianoacrilatos,
gelatina/resorcinol/formol, proteína adhesiva de mejillón y
adhesivo de fibrinógeno autólogo. También se han usado geles de
fibrina como selladores y adhesivos en cirugía, y se han usado
hidrogeles como selladores para órganos sangrantes, y para producir
soportes de tejidos para el tratamiento de enfermedades vasculares
mediante la formación de artículos conformados para servir a una
función mecánica. Los catéteres se han usado habitualmente para
introducir tales agentes terapéuticos en la vecindad de las
regiones ocluidas enfermas de la vasculatura para promover la
curación de los vasos. Típicamente, se introduce en el lumen del
vaso sanguíneo un material polímero pavimentante y sellador en forma
de una disolución de monómero, disolución de prepolímero, o como un
producto polímero preformado o parcialmente preformado, y se coloca
en el punto de una estenosis. Típicamente, el material polímero
puede incorporar agentes terapéuticos adicionales para acelerar el
proceso de curación, tales como fármacos, células productoras de
fármacos, factores de regeneración celular, y células progenitoras
del mismo tipo que las del tejido vascular del aneurisma o
histológicamente diferentes.
También se han usado los hidrogeles para formar
stents que se expanden, hinchables, y como agentes de relleno para
el tratamiento de aneurismas vasculares de un modo parecido a otros
tipos de dispositivos mecánicos vasooclusivos generadores de
émbolos. En uno de tales procedimientos, se trata un aneurisma
insertando en el vaso un stent formado por un material de hidrogel,
y después hidratando y expandiendo el material de hidrogel hasta
que el stent ocluye la pared vascular, sellándola del vaso parental.
También se han usado hidrogeles biodegradables como vehículos de
liberación controlada para materiales biológicamente activos tales
como hormonas, enzimas, antibióticos, agentes antineoplásicos y
suspensiones celulares.
A partir de lo anterior, se ha visto que los
dispositivos y materiales vasooclusivos y sus sistemas de
despliegue proporcionan tratamientos valiosos para las regiones
vasculares enfermas. Sin embargo, continúan quedando limitaciones
importantes en la tecnología actualmente disponible, ya que tratar
un aneurisma con agente adhesivo u ocluir el aneurisma con un stent
puede no ser completamente efectivo para curar el daño vascular.
Además, cuando se usa un dispositivo vasooclusivo generador de
émbolo o un dispositivo de relleno, tal como una bobina
vasooclusiva, para tratar un aneurisma, la capacidad para tratar el
aneurisma depende de si el dispositivo vasooclusivo generador de
émbolo puede migrar fuera del aneurisma a través del cuello del
aneurisma. Por lo tanto, sería deseable proporcionar un método para
obturar el cuello de un aneurisma o todo el aneurisma, además de o
como una alternativa a la introducción de un dispositivo
vasooclusivo en el aneurisma, con el fin de evitar el peligro de la
migración de un dispositivo generador de émbolo fuera del
aneurisma, para evitar al paciente el daño procedente del estallido
del aneurisma, y para promover la curación de la vasculatura
enferma, de un modo que se pueda visualizar mediante fluoroscopia.
La presente invención cumple estas y otras necesidades.
Según la invención, se proporciona un dispositivo
para tratar un aneurisma como se expone en la reivindicación 1.
La presente invención resuelve los problemas
expuestos anteriormente y otros usando un dispositivo para tratar
un aneurisma. El dispositivo se configura para permitir que un
hidrogel transporte factores de crecimiento para promover el
crecimiento celular a lo largo del cuello del aneurisma y para
eliminar y curar el aneurisma con el crecimiento celular del propio
cuerpo. Además de suministrar el factor de crecimiento, el hidrogel
actúa como un agente embólico bloqueando el flujo de sangre dentro
del aneurisma y eliminando la posibilidad de hemorragia, y se usa
en combinación con una bobina vasooclusiva generadora de émbolo en
el tratamiento de los aneurismas.
Brevemente, y en términos generales, el método
que usa el dispositivo según la invención incluye el tratamiento de
los aneurismas de forma no mecánica, mediante la administración de
factores de crecimiento humano y/o terapia génica en el sitio de un
aneurisma. El hidrogel actúa como un vehículo tanto para un agente
radio-opaco que permite que el hidrogel se pueda
visualizar mediante fluoroscopia como para un agente terapéutico,
tal como uno o más factores de crecimiento humano. El hidrogel se
administra a través de un catéter en el interior del aneurisma, en
donde el hidrogel se puede volver más viscoso al alcanzar la
temperatura corporal, o al exponerse a los fluidos corporales.
Convenientemente, el hidrogel está constituido de manera que
permanezca líquido a temperaturas por debajo de aproximadamente
37ºC, para facilitar de ese modo la colocación y retención dentro
del aneurisma del gel y de los agentes contenidos en el gel.
Preferiblemente, el hidrogel después se solidifica para bloquear el
flujo sanguíneo dentro del aneurisma. Además de parar el flujo
sanguíneo dentro del aneurisma, la administración de factores de
crecimiento humano al sitio el aneurisma promueve el crecimiento de
una capa celular a lo largo del cuello del aneurisma. El hidrogel
puede ser de un tipo que se disuelve con el tiempo o uno que
permanece como un agente oclusivo permanente dentro del
aneurisma.
aneurisma.
Estos y otros aspectos y ventajas de la invención
serán evidentes a partir de la siguiente descripción detallada.
El tratamiento de un aneurisma sellándolo con un
agente adhesivo, bloqueándolo con un stent, o colocando un
dispositivo vasooclusivo para ocluirlo puede no ser completamente
efectivo en curar el daño vascular. Un dispositivo vasooclusivo o de
relleno colocado dentro del aneurisma puede también migrar fuera
del aneurisma a través del cuello del aneurisma.
Por consiguiente, la invención proporciona un
hidrogel que actúa como un vehículo tanto para el agente
radio-opaco que permite que el hidrogel se pueda
visualizar mediante fluoroscopia como para un agente terapéutico,
tal como uno o más factores de crecimiento humano. Como se usa en
esta solicitud, el término "hidrogel" se refiere a una
categoría amplia de materiales polímeros que tienen afinidad por el
agua y que típicamente se hinchan en agua, pero que no se disuelven
en agua necesariamente. En general, los hidrogeles se forman por
polimerización y reticulado de un monómero hidrófilo en una
disolución acuosa para hacer que la disolución se gelifique. En una
realización preferida actualmente, el hidrogel puede estar
constituido para que sea líquido a una temperatura por debajo de la
temperatura corporal y para gelificar a temperatura corporal, de
manera que el gel se puede introducir fácilmente en el interior del
aneurisma, pero gelifica rápidamente en el espacio para ocluir al
menos una porción del aneurisma.
El hidrogel de la presente invención puede ser
uno o más hidrogeles seleccionados entre geles orgánicos y geles
inorgánicos. Los geles orgánicos a partir de los cuales se puede
seleccionar el hidrogel de la invención incluyen, a modo de ejemplo
y no a modo de limitación, geles formados a partir de polisacáridos
y mucopolisacáridos incluyendo, pero sin limitarse a, ácido
hialurónico, dextrano, sulfato de heparina, sulfato de condroitina,
heparina, agar, almidón, y alginato; poliaminoácidos; proteínas que
ayudan al crecimiento y la curación celular, incluyendo, pero sin
limitarse a, fibronectina, gelatina, colágeno, fibrina, pectinas,
albúmina, ovalbúmina, y ácidos poliamino;
colágeno-hidroxietil-metacrilato
(HEMA); polifosfacinas; polifosfoésteres; polietilenglicol;
poli(óxido de etileno); alcohol polivinílico; polivinilpirrolidona;
polietiloxazolina; copolímeros de bloques de poli(óxido de
etileno)-co-poli(óxido de
propileno); copolímeros de bloques
PGA-PEG-PGA; copolímeros de
dibloques PGA-PEG; acrilatos, incluyendo, pero sin
limitarse a, diacrilatos, oligoacrilatos, metacrilatos,
dimetacrilatos y oligometacrilatos;
PEG-oligoglicolilacrilatos, tales como los descritos
en la patente de EE.UU. 5.626.863; carboxi alquil celulosas,
incluyendo, pero sin limitarse a, carboximetil celulosa; celulosa
parcialmente oxidada; polímeros biodegradables incluyendo, pero sin
limitarse a, polímeros y oligómeros de glicólido, láctido, ácido
poliláctico, poliésteres de \alpha-hidroxiácidos,
incluyendo ácido láctico y ácido glicólico, tales como los
poli(\alpha-hidroxiácidos) incluyendo ácido
poliglicólico, ácido
poli-DL-láctico, ácido
poli-L-láctico, y terpolímeros de
DL-láctido y glicólido;
\varepsilon-caprolactona y
\varepsilon-caprolactona copolimerizada con
poliésteres; polilactonas y policaprolactonas incluyendo
poli(\varepsilon-caprolactona),
poli(\delta-valerolactona) y
poli(gamma-butirolactona); polianhídridos;
poliortoésteres; otros hidroxiácidos; polidioxanona; y otros
polímeros biológicamente degradables que no son tóxicos o están
presentes como metabolitos en el cuerpo; así como polímeros no
degradables tales como estireno y acroleína.
Habitualmente, el polímero hidrogel de
colágeno-hidroxietil-metacrilato
(HEMA) se forma a partir de una disolución de monómero hidrófilo
gelificado y reticulado para formar una malla polímera
tridimensional que ancla las macromoléculas. El reticulado de la
disolución de monómero hidrófilo se puede realizar mediante
polimerización por radicales libres de monómeros hidrófilos, tales
como hidroxietil-metacrilato (HEMA). Los polímeros
hidrogel formados mediante polimerización por radicales libres de
disoluciones del monómero requieren el reticulado para formar una
red tridimensional que gelifique la disolución acuosa. Típicamente,
las disoluciones de monómero HEMA se pueden reticular para
gelificarse mediante dimetacrilato, aunque para modificar el
hidrogel también se pueden usar durante la polimerización otros
agentes reticulantes, tales como dimetacrilato o metilmetacrilato
de etilenglicol. También pueden ser adecuados para los propósitos
de la invención una amplia variedad de otros monómeros
hidrófilos.
Los geles inorgánicos a partir de los cuales se
puede seleccionar el hidrogel de la invención incluyen, a modo de
ejemplo y no a modo de limitación, sílice, alúmina, y óxido
férrico. Además, se puede introducir un agente adhesivo mediante un
catéter para ayudar al sellado inicial del cuello de un aneurisma,
y se puede seleccionar entre el grupo que consiste en
cianoacrilatos, gelatina/resorcinol/formol, proteína adhesiva de
mejillón y adhesivo de fibrinógeno autólogo. De este modo, debería
ser evidente que el hidrogel de la invención puede ser de un tipo
que se disuelve con el tiempo o de uno que permanece como un agente
oclusivo permanente dentro del aneurisma.
Preferiblemente, el material
radio-opaco que se incorpora en el hidrogel de la
invención es partículas finas de un metal
radio-opaco seleccionado, tal como oro, platino,
tántalo o similar. Preferiblemente, el agente terapéutico que se
incorpora en el hidrogel de la invención para acelerar el proceso
de curación es uno o más factores que modulan el crecimiento humano
tales como interleucinas, factor b de transformación y crecimiento,
agentes de terapia génica, factores de crecimiento derivados de
congéneres de plaquetas, y anticuerpos monoclonales dirigidos
contra los factores del crecimiento, fármacos, células productoras
de fármacos, factores de regeneración celular, células progenitoras
del mismo tipo que las del aneurisma, y células progenitoras que son
histológicamente diferentes de las del aneurisma. El agente
terapéutico se puede administrar en forma de partículas finas
mezcladas con el polímero de manera que gelifique dentro del
aneurisma para concentrar el efecto del agente terapéutico en el
interior del aneurisma.
Según un método de uso del dispositivo de la
invención, típicamente se posiciona un catéter en una vaso parental
del aneurisma, y se administra el hidrogel de la invención a través
del catéter en el interior del aneurisma, donde el hidrogel se
vuelve más viscoso después de alcanzar la temperatura corporal, o
después de exponerse a los fluidos corporales. Durante la
introducción del hidrogel en el aneurisma, se puede visualizar el
hidrogel por técnicas fluoroscópicas habituales para permitir al
medico monitorizar el tratamiento del aneurisma. Una vez
introducido en el interior del aneurisma, preferiblemente el
hidrogel adicionalmente se reticula para solidificarse y bloquear el
flujo sanguíneo en el aneurisma, y los uno o más agentes
terapéuticos transportados por el hidrogel gradualmente se difunden
y dispersan desde el hidrogel al interior del aneurisma, para
promover el crecimiento de una capa celular a lo largo del cuello
del aneurisma.
Claims (10)
1. Un dispositivo para tratar un aneurisma, que
tiene una porción abovedada y un cuello que se abre en un vaso
parental, teniendo el dispositivo la combinación de una bobina
vasooclusiva generadora de émbolo y un hidrogel, en el que la bobina
vasooclusiva generadora de émbolo se introduce en el aneurisma para
permitir la administración del hidrogel dentro de la porción
abovedada del aneurisma y adyacente al cuello del aneurisma,
conteniendo el hidrogel un material radio-opaco y un
agente terapéutico que se libera desde el hidrogel en el aneurisma
para promover el crecimiento celular a lo largo del cuello del
aneurisma para cerrar el cuello del aneurisma.
2. El dispositivo de la reivindicación 1, en el
que dicho hidrogel se selecciona entre geles orgánicos y geles
inorgánicos.
3. El dispositivo de la reivindicación 1, en el
que dicho hidrogel se selecciona entre polímeros biodegradables y
polímeros no biodegradables.
4. El dispositivo de la reivindicación 1, en el
que dicho hidrogel se selecciona entre los geles formados a partir
de polisacáridos, mucopolisacáridos, poliaminoácidos, proteínas que
ayudan al crecimiento y la curación celular, polifosfacinas,
polifosfoésteres, polietilenglicol, poli(óxido de etileno), alcohol
polivinílico, polivinilpirrolidona, polietiloxazolina, copolímeros
de bloques poli(óxido de
etileno)-co-poli(óxido de
propileno), copolímeros de bloques
PGA-PEG-PGA, copolímeros de bloques
PGA-PEG, acrilatos,
carboxi-alquil-celulosas, celulosa
parcialmente oxidados, polímeros y oligómeros de glicólido y
láctido, ácido poliláctico, poliésteres de
\alpha-hidroxiácidos, polilactonas,
policaprolactonas, polianhídridos; poliortoésteres, polidioxanona,
estireno, acroleína y sus combinaciones.
5. El dispositivo de la reivindicación 1, en el
que dicho hidrogel se selecciona entre los geles formados a partir
de ácido hialurónico, dextrano, sulfato de heparina, sulfato de
condroitina, heparina, agar, almidón, alginato, fibronectina,
gelatina, colágeno, fibrina, pectinas, albúmina, ovalbúmina,
colágeno-hidroxietil-metacrilato
(HEMA), diacrilatos, oligoacrilatos, metacrilatos, dimetacrilatos,
oligometacrilatos; PEG-oligoglicolilacrilatos,
carboximetil celulosa, poliésteres de ácido láctico, poliésteres de
ácido glicólico,
poli(\alpha-hidroxiácidos) incluyendo ácido
poliglicólico, ácido
poli-DL-láctico, ácido
poli-L-láctico, y terpolímeros de
DL-láctido y glicólido,
\varepsilon-caprolactona,
\varepsilon-caprolactona copolimerizada con
poliésteres,
poli(\varepsilon-caprolactona),
poli(\delta-valerolactona),
poli(gamma-butirolactona), y sus
combinaciones.
6. El dispositivo de la reivindicación 1, en el
que dicho hidrogel se selecciona entre los geles formados a partir
de sílice, alúmina, óxido férrico, y sus combinaciones.
7. El dispositivo de la reivindicación 1, en el
que dicho material radio-opaco se selecciona entre
partículas finas de oro, platino, tántalo y sus combinaciones.
8. El dispositivo de la reivindicación 1, en el
que dicho agente terapéutico se selecciona entre interleucinas,
factor b de transformación y crecimiento, factor de crecimiento
derivado de congéneres de plaquetas, y anticuerpos monoclonales
dirigidos contra los factores de crecimiento, fármacos, células
productoras de fármacos, factores de regeneración celular, células
progenitoras del mismo tipo que las del aneurisma, y células
progenitoras que son histológicamente diferentes de las del
aneurisma.
9. El dispositivo de la reivindicación 1, en el
que dicho agente terapéutico es un factor de crecimiento.
10. El dispositivo de la reivindicación 1, en el
que dicho hidrogel está constituido para ser un líquido a una
temperatura por debajo de la temperatura corporal y gelifica a
temperatura corporal.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/071,250 US6113629A (en) | 1998-05-01 | 1998-05-01 | Hydrogel for the therapeutic treatment of aneurysms |
US71250 | 1998-05-01 |
Publications (1)
Publication Number | Publication Date |
---|---|
ES2251190T3 true ES2251190T3 (es) | 2006-04-16 |
Family
ID=22100190
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES99918935T Expired - Lifetime ES2251190T3 (es) | 1998-05-01 | 1999-04-29 | Hidrogel para el tratamiento terapeutico de aneurismas. |
Country Status (7)
Country | Link |
---|---|
US (2) | US6113629A (es) |
EP (1) | EP1100541B1 (es) |
JP (1) | JP5507028B2 (es) |
AU (1) | AU3673499A (es) |
DE (1) | DE69927823T2 (es) |
ES (1) | ES2251190T3 (es) |
WO (1) | WO1999056783A1 (es) |
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1999
- 1999-04-29 EP EP99918935A patent/EP1100541B1/en not_active Expired - Lifetime
- 1999-04-29 AU AU36734/99A patent/AU3673499A/en not_active Abandoned
- 1999-04-29 WO PCT/US1999/009492 patent/WO1999056783A1/en active IP Right Grant
- 1999-04-29 JP JP2000546807A patent/JP5507028B2/ja not_active Expired - Fee Related
- 1999-04-29 DE DE69927823T patent/DE69927823T2/de not_active Expired - Lifetime
- 1999-04-29 ES ES99918935T patent/ES2251190T3/es not_active Expired - Lifetime
-
2002
- 2002-10-02 US US10/263,387 patent/US20030100942A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
DE69927823T2 (de) | 2006-06-14 |
US20030100942A1 (en) | 2003-05-29 |
JP5507028B2 (ja) | 2014-05-28 |
DE69927823D1 (de) | 2006-03-02 |
EP1100541A1 (en) | 2001-05-23 |
US6113629A (en) | 2000-09-05 |
AU3673499A (en) | 1999-11-23 |
WO1999056783A1 (en) | 1999-11-11 |
EP1100541B1 (en) | 2005-10-19 |
JP2002531379A (ja) | 2002-09-24 |
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