ES2251999T3 - Dispositivo de stent para tratar glaucoma. - Google Patents
Dispositivo de stent para tratar glaucoma.Info
- Publication number
- ES2251999T3 ES2251999T3 ES00928419T ES00928419T ES2251999T3 ES 2251999 T3 ES2251999 T3 ES 2251999T3 ES 00928419 T ES00928419 T ES 00928419T ES 00928419 T ES00928419 T ES 00928419T ES 2251999 T3 ES2251999 T3 ES 2251999T3
- Authority
- ES
- Spain
- Prior art keywords
- schlemm
- channel
- stent
- approximately
- eye
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
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Classifications
-
- 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
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
-
- 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
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
- A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
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- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
- A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
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- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
Landscapes
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- General Health & Medical Sciences (AREA)
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- Biophysics (AREA)
- Vascular Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Surgery (AREA)
- Prostheses (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Radiation-Therapy Devices (AREA)
- External Artificial Organs (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Eye Examination Apparatus (AREA)
- Materials For Medical Uses (AREA)
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- Crystals, And After-Treatments Of Crystals (AREA)
- Arc Welding In General (AREA)
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Abstract
Un dispositivo de stent para uso en el ojo con el fin de aliviar el exceso de presión intraocular facilitando el drenaje a través del canal de Schlemm y dentro del mismo, comprendiendo el dispositivo: un cuerpo delgado (10) de material biocompatible de una longitud y forma adaptadas para que quede totalmente retenido dentro de una porción del canal de Schlemm (30), en donde (a) dicho cuerpo (10) está curvado para definir una abertura de canal (5) en forma de artesa en toda la longitud de dicho cuerpo (10), (b) dicho cuerpo (10) tiene un diámetro exterior de aproximadamente 0, 1 mm hasta 0, 5 mm, y (c) dicho cuerpo (10) tiene una longitud de aproximadamente 1 mm hasta 40 mm.
Description
Dispositivo de stent para tratar glaucoma.
La presente invención se dirige en general a un
tratamiento quirúrgico del glaucoma, y se refiere, en particular,
a un dispositivo para mantener continuamente la patencia del canal
de Schlemm mediante un stent residente similar a una artesa que se
puede colocar quirúrgicamente de modo que atraviese al menos una
parte de la circunferencia del canal y facilite el drenaje a su
través del humor acuoso.
El glaucoma es un problema significativo de salud
pública, dado que es una causa importante de ceguera. La ceguera a
consecuencia del glaucoma implica tanto a la visión central como a
la periférica y tiene un impacto importante en la capacidad de las
personas para llevar una vida independiente.
El glaucoma es una neuropatía óptica (un desorden
del nervio óptico) que normalmente ocurre en el ambiente de una
elevada presión intraocular. La presión dentro del ojo aumenta y
esto se asocia a cambios en el aspecto ("acopamiento") y
función ("puntos ciegos" en el campo visual) del nervio
óptico. Si la presión permanece lo suficientemente alta durante un
periodo de tiempo suficiente, tiene lugar una pérdida total de
visión. La alta presión se desarrolla en un ojo debido a un
desequilibrio del fluido interno.
El ojo es una estructura hueca que contiene un
fluido transparente denominado "humor acuoso". El humor acuoso
se forma en la cámara posterior del ojo por el cuerpo ciliar a una
tasa de aproximadamente 2,5 microlitros por minuto. El fluido, que
se produce a una tasa bastante constante, pasa luego alrededor del
cristalino, a través de la abertura pupilar del iris y hacia la
cámara anterior del ojo. Una vez en la cámara anterior, el fluido
drena hacia el exterior del ojo a través de dos rutas diferentes. En
la ruta "uveoescleral", el fluido se filtra entre fibras
musculares del cuerpo ciliar. Esta ruta supone aproximadamente un
diez por ciento de la emanación acuosa de los humanos. La
trayectoria principal de la emanación acuosa de los humanos es a
través de la ruta "canalicular", que implica a la malla
trabecular y al canal
de Schlemm.
de Schlemm.
La malla trabecular y el canal de Schlemm están
situados en la unión entre el iris y la esclerótica. Esta unión o
esquina se denomina "el ángulo". La malla trabecular es una
estructura en forma de cuña que corre alrededor de la
circunferencia del ojo. Esta compuesta por haces de colágeno
dispuestos según una estructura tridimensional similar a un tamiz.
Los haces están alineados con una monocapa de células denominadas
células trabeculares. Los espacios entre los haces de colágeno
están llenos de una sustancia extracelular que es producida por
las células trabeculares. Estas células también producen enzimas que
degradan el material extracelular. El canal de Schlemm es
adyacente a la malla trabecular. La pared exterior de la malla
trabecular coincide con la pared interior del canal de Schlemm. El
canal de Schlemm es una estructura similar a un tubo que corre
alrededor de la circunferencia de la córnea. En adultos humanos, se
cree que el canal de Schlemm está divido por septos en una serie
de canales autónomos sin salida.
El fluido acuoso viaja a través de los espacios
entre los haces trabeculares, a través de la pared interior del
canal de Schlemm hacia el canal, a través de una serie de 25 canales
colectores que drenan desde el canal de Schlemm y hacia el sistema
venoso episclerótico. En una situación normal, la producción acuosa
es igual a la emanación acuosa y la presión intraocular permanece
bastante constante en el intervalo de 15 a 21 mmHg. En el
glaucoma, es anormalmente alta la resistencia a través del sistema
de emanación canalicular.
En un glaucoma primario de ángulo abierto, que es
la forma más común de glaucoma, se cree que la resistencia anormal
se produce a lo largo del aspecto exterior de la malla trabecular y
de la pared interior del canal de Schlemm. Se cree que un
metabolismo anormal de las células trabeculares provoca una
acumulación excesiva de materiales extracelulares o una acumulación
de materiales anormalmente "rígidos" en esta área. La
histopatología de ojos con glaucoma también demuestra un
aplastamiento del canal de Schlemm. El glaucoma primario de ángulo
abierto supone aproximadamente el ochenta y cinco por ciento de
todos los glaucomas. Otras formas de glaucoma (tales como el
glaucoma de cierre de ángulo y los glaucomas secundarios) también
implican una emanación disminuida a través de la trayectoria
canalicular, pero la resistencia aumentada proviene de otras causas
tales como un bloqueo mecánico, desechos inflamatorios, bloqueo
celular, etc.
Con la resistencia aumentada, el fluido acuoso se
acumula debido a que no puede salir lo suficientemente rápido. A
medida que el fluido se acumula, aumenta la presión intraocular
(IOP) dentro del ojo. La IOP aumentada comprime los axones del
nervio óptico y también puede comprometer el suministro vascular
hacia el nervio óptico. El nervio óptico lleva la visión desde el
ojo al cerebro. Algunos nervios ópticos parecen más susceptibles a
la IOP que otros ojos. Aunque la investigación está analizando
maneras de proteger el nervio contra una presión elevada, el único
enfoque terapéutico actualmente disponible para el glaucoma es
reducir la presión intraocular.
El tratamiento clínico del glaucoma se aborda
según un modo paso a paso. A menudo, la medicación es la primera
opción de tratamiento. Administradas tópica u oralmente, estas
medicaciones trabajan reduciendo la producción acuosa, o actúan
aumentando la emanación. Las medicaciones actualmente disponible
pueden tener muchos efectos secundarios serios que incluyen: fallo
congestivo del corazón, ansiedad respiratoria, hipertensión,
depresión, cálculos renales, anemia aplástica, disfunción sexual y
muerte. El acatamiento de la medicación es un problema importante,
estimándose que más de la mitad de los pacientes de glaucoma no
siguen sus programas de dosificación correcta.
Cuando la medicación deja de reducir
adecuadamente la presión, se realiza a menudo una trabeculoplastia
por láser. En la trabeculoplastia por láser, se aplica la energía
térmica de un láser a una serie de puntos no contiguos de la malla
trabecular. Se cree que la energía del láser estimula de alguna
manera el metabolismo de las células trabeculares, y cambia el
material extracelular de la malla trabecular. En aproximadamente
el ochenta por ciento de pacientes, la emanación acuosa resulta
incrementada y disminuye la IOP. Sin embargo, a menudo el efecto
no es duradero y el cincuenta por ciento de los pacientes
desarrolla una elevada presión en cinco años. Normalmente, la
cirugía con láser no es repetible. Además, la trabeculoplastia por
láser no es un tratamiento efectivo para el glaucoma primario de
ángulo abierto en pacientes menores de cincuenta años ni tampoco
es efectivo para el glaucoma de cierre de ángulo y muchos glaucomas
secundarios.
Si la trabeculoplastia por láser no reduce
suficientemente la presión, se realiza entonces cirugía de
filtrado. Con la cirugía de filtrado se hace un agujero en la
esclerótica y en la región angular. Este agujero permite que el
fluido acuoso abandone el ojo a través de una ruta alternativa.
El procedimiento de filtrado más comúnmente
realizado es una trabeculectomía. En una trabeculectomía se realiza
una incisión posterior en la conjuntiva, el tejido transparente que
cubre la esclerótica. La conjuntiva está enrollada hacia delante,
mostrando la esclerótica en el limbo. Se realiza una solapa
escleral de grosor parcial y se disecciona medio grosor dentro de
la córnea. Se entra a la cámara anterior por debajo de la solapa
escleral y se extirpa una sección de la esclerótica profunda y de
la malla trabecular. La solapa escleral se cose holgadamente de
nuevo en su sitio. La incisión conjuntiva se cierra ajustadamente.
En el postoperatorio, el fluido acuoso atraviesa el agujero, por
debajo de la solapa escleral, y se recoge en un espacio elevado
debajo de la conjuntiva. El fluido es absorbido entonces a través
de los vasos sanguíneos de la conjuntiva o atraviesa la conjuntiva
hacia la película lacrimosa.
La trabeculectomía está asociada a muchos
problemas. Los fibroblastos que están presentes en la episclera
proliferan y migran y pueden cicatrizar la solapa escleral. Pueden
producirse fallos de cicatrición, particularmente en niños y
adultos jóvenes. De los ojos objeto de una trabeculectomía
inicialmente exitosa, un ochenta por ciento dejarán de cicatrizar
en un periodo de tres a cinco años tras la cirugía. Para minimizar
la fibrosis, los cirujanos están aplicando ahora agentes
antifibróticos tales como mitomicina
C (MMC) y 5-fluorouracilo (5-FU) a la solapa escleral en el momento de la cirugía. El uso de estos agentes ha aumentado la tasa de éxito de la trabeculectomía, pero también ha aumentado la prevalencia de la hipotonía. La hipotonía es un problema que se desarrolla cuando el fluido acuoso sale del ojo demasiado rápido. La presión del ojo cae muy abajo (usualmente menos de 6,0 mmHg); la estructura del ojo se aplasta y la visión disminuye.
C (MMC) y 5-fluorouracilo (5-FU) a la solapa escleral en el momento de la cirugía. El uso de estos agentes ha aumentado la tasa de éxito de la trabeculectomía, pero también ha aumentado la prevalencia de la hipotonía. La hipotonía es un problema que se desarrolla cuando el fluido acuoso sale del ojo demasiado rápido. La presión del ojo cae muy abajo (usualmente menos de 6,0 mmHg); la estructura del ojo se aplasta y la visión disminuye.
La trabeculectomía crea una trayectoria para que
el fluido acuoso escape hacia la superficie del ojo. Al mismo
tiempo, crea una trayectoria para que las bacterias que normalmente
viven en la superficie del ojo y de los párpados entren en el ojo.
Si esto sucede, puede tener lugar una infección interna del ojo
denominada endoftalmitis. La endoftalmitis conduce a menudo a una
pérdida de visión permanente y profunda. La endoftalmitis puede
tener lugar en cualquier momento después de una trabeculectomía. El
riesgo aumenta con las finas ampollas que se desarrollan tras MMC
y 5-FU. Otro factor que contribuye a la infección es
la colocación de una ampolla. Los ojos objeto de una
trabeculectomía realizada inferiormente multiplican aproximadamente
por cinco el riesgo de una infección ocular en comparación con los
ojos que tienen una ampolla superior. Por tanto, se realiza
superiormente una trabeculectomía inicial bajo el párpado, en el
cuadrante nasal o temporal.
Además de la cicatrización, la hipotonía y la
infección, existen otras complicaciones de la trabeculectomía. La
ampolla puede rasgarse y provocar una hipotonía profunda. La ampolla
puede ser irritante y dislocar la película lacrimosa normal,
provocando una visión borrosa. En general, los pacientes con
ampollas con pueden llevar lentes de contacto. Todas las
complicaciones derivadas de la trabeculectomía surgen del hecho de
que se está desviando fluido desde el interior del ojo hacia la
superficie externa
del ojo.
del ojo.
Cuando la trabeculectomía no rebaja con éxito la
presión del ojo, a menudo el siguiente paso quirúrgico es un
dispositivo de derivación acuosa. Un dispositivo de derivación
acuosa de la técnica anterior es un tubo de silicona que está
fijado por un extremo a una placa de plástico (polipropileno u otro
sintético). Con un dispositivo de derivación acuosa, se realiza una
incisión en la conjuntiva, exponiendo la esclerótica. La placa de
plástico se cose posteriormente a la superficie del ojo, normalmente
sobre el ecuador. Se hace un agujero de grosor entero hacia dentro
el ojo en el limbo, normalmente con una aguja. El tubo se inserta
dentro del ojo a través de este agujero. La porción externa del
tubo se cubre con esclerótica o pericardio de donante. Se
reemplaza la conjuntiva y se cierra ajustadamente la incisión.
Existen muchos problemas con la tecnología actual de dispositivos
de derivación acuosa, incluyendo cicatrización, fallo, hipotonía e
infección.
Algunas referencias de la técnica anterior para
la gestión del glaucoma se han dirigido al canal de
Schlemm, pero éstas no han implicado la colocación de stents interiores de larga duración. Por ejemplo, la patente norteamericana número 5.360.399 muestra la colocación de una porción de un tubo de plástico o acero en el canal de Schlemm con inyección de un material viscoso a través del tubo para diseccionar hidráulicamente la malla trabecular. El tubo se retira del canal tras la inyección. Además, con relación a esa porción del interior del canal de Schlemm, el dispositivo de la patente 5.360.399 tiene un elemento de manguito de inyección con un diámetro mayor, el cual sirve como adaptador de inyección e irrigación. Por tanto, este dispositivo no está destinado a una colocación permanente dentro del canal de Schlemm.
Schlemm, pero éstas no han implicado la colocación de stents interiores de larga duración. Por ejemplo, la patente norteamericana número 5.360.399 muestra la colocación de una porción de un tubo de plástico o acero en el canal de Schlemm con inyección de un material viscoso a través del tubo para diseccionar hidráulicamente la malla trabecular. El tubo se retira del canal tras la inyección. Además, con relación a esa porción del interior del canal de Schlemm, el dispositivo de la patente 5.360.399 tiene un elemento de manguito de inyección con un diámetro mayor, el cual sirve como adaptador de inyección e irrigación. Por tanto, este dispositivo no está destinado a una colocación permanente dentro del canal de Schlemm.
El documento EP 0 898 947 describe un dispositivo
de stent que puede insertarse dentro del canal de Schlemm para
aliviar el exceso de presión intraocular facilitando el drenaje.
El documento WO 00/13627, como técnica anterior
según el artículo 54(3) y (4) del CPE, muestra un
dispositivo de stent con dos aberturas ovales en la pared del
stent.
Por tanto, existe una necesidad de un sistema más
fisiológico para aumentar el drenaje de fluido acuoso a través del
canal de Schlemm.
El aumento del flujo acuoso directamente hacia el
canal de Schlemm minimizaría la cicatrización, dado que la región
angular está poblada por una sola línea de células trabeculares no
proliferantes. El aumento del flujo acuoso directamente hacia el
canal de
Schlemm minimizaría la hipotonía, dado que el canal es parte del sistema de emanación normal y está diseñado biológicamente para manejar el volumen normal de humor acuoso. El aumento del flujo acuoso directamente hacia el canal de Schlemm eliminaría complicaciones tales como la endoftalmitis y fugas.
Schlemm minimizaría la hipotonía, dado que el canal es parte del sistema de emanación normal y está diseñado biológicamente para manejar el volumen normal de humor acuoso. El aumento del flujo acuoso directamente hacia el canal de Schlemm eliminaría complicaciones tales como la endoftalmitis y fugas.
La presente invención proporciona un dispositivo
de stent según la reivindicación 1, en el cual el stent se coloca
dentro del canal de Schlemm para expandir las dimensiones del canal
y mantener su patencia. Por tanto, la presente invención facilita
el camino fisiológico normal para el drenaje del humor acuoso hacia
el canal de Schlemm y a través del mismo. La presente invención se
dirige además a proporcionar un stent residente permanente dentro
del canal de Schlemm para la gestión del glaucoma.
La figura 1 es una ilustración que muestra una
vista lateral de una realización comparativa no cubiertas por las
reivindicaciones anexas, en la que el stent está compuesto por
elementos tubulares que atraviesan la circunferencia del canal de
Schlemm.
La figura 2 es una ilustración que muestra otra
realización comparativa no cubierta por las reivindicaciones
anexas, en la que el stent está compuesto por elementos tubulares de
malla luminal.
La figura 3 es una ilustración que muestra una
realización de la presente invención, en la que el paso inventivo
está compuesto por elementos que tienen una configuración
abierta.
La figura 4 es una ilustración que muestra los
detalles anatómicos del ojo humano.
La figura 5 es una ilustración que muestra las
relaciones anatómicas (no a escala) de la colocación quirúrgica de
un dispositivo de stent.
La presente invención proporciona un dispositivo
de stent de humor acuoso que se ha de colocar dentro de una
porción del canal de Schlemm del ojo como un implante residente para
expandir y mantener la patencia del canal, en el que el
dispositivo de stent comprende una porción de cuerpo conformada
para que sea totalmente recibida dentro del canal de Schlemm a fin
de facilitar el drenaje natural del humor acuoso hacia los canales
colectores del ojo.
La presente invención también proporciona
realizaciones de un stent inventivo que comprende un cuerpo delgado
de material biocompatible con una longitud y forma adaptadas para
que sea totalmente recibido dentro del canal de Schlemm y para que
se extienda dentro de una porción de la circunferencia del canal de
Schlemm, y que tiene un canal en su interior para facilitar el paso
de humor acuoso hacia el canal de Schlemm, y a través del mismo,
hasta los canales colectores. La invención contempla configuraciones
de un dispositivo de stent que ayudan a canalizar humor acuoso por
todo el canal de Schlemm proporcionando una artesa. El cuerpo del
stent puede moverse entre una primera posición de inserción y una
segunda posición de stent expandido cuando se encuentra en un
lugar deseado del canal. El dispositivo que se extiende hacia el
canal de Schlemm puede formarse a partir de un material
biológicamente inerte flexible poroso o no poroso de manera que se
iguale aproximadamente a una porción del radio, curvatura y
diámetro del canal de Schlemm. Todo el dispositivo o partes del
mismo pueden ser tubulares o no tubulares y estar fenestrados o no.
El dispositivo puede dimensionarse además para permitir la
colocación a través de toda, o parte, de la circunferencia del
canal
de Schlemm.
de Schlemm.
Las enseñanzas tradicionales del glaucoma señalan
que el canal de Schlemm de un adulto está dividido por septos en
canales independientes, haciendo imposible el paso completo de una
sutura. Estudios preliminares en ojos de un banco de ojos humanos
adultos han demostrado que el canal de Schlemm es efectivamente
patente. Se puede hacer pasar una sutura a través de toda la
circunferencia del canal. Hasta ahora no se ha determinado que el
canal de Schlemm esté patente en toda su circunferencia en
individuos normales, en oposición a que esté dividido por septos
en múltiples canales sin salida. La presente invención utiliza este
conocimiento para crear y mantener la patencia dentro del canal de
Schlemm con los presentes dispositivos de stent.
Se ilustra una realización comparativa en la
figura 1, en la cual se muestra el dispositivo de stent 100 en una
vista lateral. El dispositivo de stent 100 está compuesto por una
porción 100 de cuerpo tubular que define un lumen 5 que puede
tener paredes tubulares sólidas o puede contener una pluralidad de
fenestraciones 15 que se comunican entre el lumen 5 y el exterior.
La porción de cuerpo tiene una curvatura preformada con un radio r
que se aproxima al radio de 6 mm del canal de Schlemm de un ojo de
un humano adulto. El diámetro en sección transversal de la porción
de cuerpo 10 está dimensionado para que sea totalmente recibido
dentro del canal de Schlemm. La porción de cuerpo 10 puede ser una
estructura tubular o poligonal cerrada, o puede ser una estructura
abierta, plana, angular o curvada, o alguna combinación de las
anteriores cuando se secciona transversalmente en sitios
diferentes a lo largo de toda su longitud. Las fenestraciones 15
pueden colocarse a lo largo de cualquier porción del dispositivo
100 para facilitar el paso de fluido a su través.
Se muestran otros ejemplos de realizaciones en
las figuras 2-3. La figura 2 muestra una
realización comparativa del stent en la que el dispositivo 100
comprende una malla tubular luminal en su configuración, de nuevo
con una curvatura preformada con un radio r para aproximarse al
radio de 6 mm del canal de
Schlemm, y con un diámetro en sección transversal de la porción de cuerpo 10 dimensionado para que sea totalmente recibida dentro del canal de Schlemm.
Schlemm, y con un diámetro en sección transversal de la porción de cuerpo 10 dimensionado para que sea totalmente recibida dentro del canal de Schlemm.
La figura 3 muestra una realización del stent
inventivo en el que la porción de cuerpo 10 está abierta y curvada
en toda su longitud en forma de un canal similar a una artesa, de
nuevo con una curvatura preformada con un radio r para aproximarse
al radio de 6 mm del canal de Schlemm y con un diámetro en sección
transversal de la porción de cuerpo 10 dimensionado para que sea
totalmente recibida dentro del canal de Schlemm.
Dado que el dispositivo inventivo es un implante
a largo plazo, puede fabricarse a partir de un material que será
inocuo para los tejidos y fluidos con los cuales está en contacto.
Es preferible que el dispositivo no sea absorbido, corroído o
comprometido estructuralmente de cualquier otra manera durante su
tenencia in situ. Además, es igualmente preferible que los
tejidos del ojo y el humor acuoso no resulten perjudicialmente
afectados por la presencia del dispositivo implantado. Se
encuentran disponibles una serie de materiales para satisfacer las
especificaciones médicas y de diseño de los stents. En las
realizaciones ejemplares de la presente invención, el dispositivo
de stent 100 está construido de un material flexible biológicamente
inerte, tal como silicona o polímeros similares. Materiales
alternativos podrían incluir, pero sin estar limitados a ellos,
politetrafluoretileno, polipropileno u otros polímeros de paredes
delgadas. También pueden usarse otros metales y aleaciones
conocidos en la técnica de construcción de stents, tales como acero
inoxidable, titanio o nitinol. El stent también puede fabricarse
con agentes terapéuticos que migren del dispositivo con el
tiempo.
En las configuraciones mostradas en las figuras
1-5, la porción de cuerpo 10 puede tener una curva
preformada para aproximarse al radio de 6,0 mm del canal de Schlemm
de un ojo humano. La porción de cuerpo 10 puede tener suficiente
longitud para extenderse a través de cualquier tramo de toda la
circunferencia del canal de Schlemm, teniendo la porción de cuerpo
10 una longitud total de aproximadamente 1 mm hasta 40 mm, o
aproximadamente 2 mm hasta 20 mm, o aproximadamente 5 mm, para
permitir la colocación circunferencial a través del canal de
Schlemm. El diámetro o anchura de la porción de cuerpo 10 puede dimensionarse para que procure un diámetro interno de entre aproximadamente 0,1 mm y 0,5 mm, preferiblemente cerca de 0,2 mm, y un diámetro externo de entre 0,1 mm y 0,5 mm, o aproximadamente 0,3 mm, para un stent tubular o curvado, o una anchura máxima comparable para un stent de configuración multiangular. La porción de cuerpo 10 puede contener una serie de fenestraciones para permitir la salida de fluidos, dispuestas para impedir la oclusión por las paredes adyacentes del canal de
Schlemm, particularmente en la dirección de los canales colectores.
Schlemm. El diámetro o anchura de la porción de cuerpo 10 puede dimensionarse para que procure un diámetro interno de entre aproximadamente 0,1 mm y 0,5 mm, preferiblemente cerca de 0,2 mm, y un diámetro externo de entre 0,1 mm y 0,5 mm, o aproximadamente 0,3 mm, para un stent tubular o curvado, o una anchura máxima comparable para un stent de configuración multiangular. La porción de cuerpo 10 puede contener una serie de fenestraciones para permitir la salida de fluidos, dispuestas para impedir la oclusión por las paredes adyacentes del canal de
Schlemm, particularmente en la dirección de los canales colectores.
La anatomía quirúrgica relevante para la presente
invención se ilustra en la figura 4. En general, la figura 4
muestra la cámara anterior 35, el canal de Schlemm 30, el iris 40,
la córnea 45, la malla trabecular 50, los canales colectores 55,
las venas episclerales 60, la pupila 65 y el cristalino 70. La
figura 5 muestra la colocación quirúrgica de un dispositivo de
stent con las relaciones anatómicas relevantes. Debe observarse
que el dispositivo inventivo está diseñado de modo que la colocación
de múltiples stents dentro del canal de Schlemm 30 pueda dar como
resultado un recorrido casi circunferencial del canal de Schlemm
30. Se cierra la incisión quirúrgica dentro del canal de Schlemm
30, sin comunicación externa directa con el dispositivo de stent
100 en
cuestión.
cuestión.
El procedimiento quirúrgico necesario para
insertar el dispositivo puede incluir todos, o algunos, de los
pasos siguientes: Se realiza una incisión conjuntiva. Se crea
entonces una solapa escleral de grosor parcial y se disecciona
medio grosor en la córnea transparente. Se identifica el aspecto
posterior del canal de
Schlemm y se entra posteriormente en el canal. La cámara anterior puede hacerse más profunda con la inyección de un agente viscoelástico o miótico. Puede introducirse en el canal de Schlemm un catéter de balón, tal como el descrito en la patente US-6.524.275, presentada el 26 de abril de 2000, e inflarse para dilatar porciones del canal de Schlemm, seguido por la deflación selectiva del balón y la colocación de uno o más dispositivos de stent dentro del canal de Schlemm. Alternativamente, los dispositivos de stent pueden introducirse directamente en un dispositivo de catéter de balón. Por tanto, pueden colocarse una serie de segmentos de stent en lugares seleccionados a lo largo de la circunferencia del canal de Schlemm. Se recorta cualquier material residual del stent, y se cierran de manera convencional la solapa escleral y la herida conjuntiva.
Schlemm y se entra posteriormente en el canal. La cámara anterior puede hacerse más profunda con la inyección de un agente viscoelástico o miótico. Puede introducirse en el canal de Schlemm un catéter de balón, tal como el descrito en la patente US-6.524.275, presentada el 26 de abril de 2000, e inflarse para dilatar porciones del canal de Schlemm, seguido por la deflación selectiva del balón y la colocación de uno o más dispositivos de stent dentro del canal de Schlemm. Alternativamente, los dispositivos de stent pueden introducirse directamente en un dispositivo de catéter de balón. Por tanto, pueden colocarse una serie de segmentos de stent en lugares seleccionados a lo largo de la circunferencia del canal de Schlemm. Se recorta cualquier material residual del stent, y se cierran de manera convencional la solapa escleral y la herida conjuntiva.
Claims (6)
1. Un dispositivo de stent para uso en el ojo con
el fin de aliviar el exceso de presión intraocular facilitando el
drenaje a través del canal de Schlemm y dentro del mismo,
comprendiendo el dispositivo: un cuerpo delgado (10) de material
biocompatible de una longitud y forma adaptadas para que quede
totalmente retenido dentro de una porción del canal de Schlemm
(30), en donde (a) dicho cuerpo (10) está curvado para definir una
abertura de canal (5) en forma de artesa en toda la longitud de
dicho cuerpo (10), (b) dicho cuerpo (10) tiene un diámetro
exterior de aproximadamente 0,1 mm hasta 0,5 mm, y (c) dicho cuerpo
(10) tiene una longitud de aproximadamente 1 mm hasta 40 mm.
2. El dispositivo de stent según la
reivindicación 1, en el que dicho cuerpo (10) tiene una curva que
tiene un radio que se aproxima al radio del canal de
Schlemm (30) de un ojo humano, en donde el radio es de entre aproximadamente 3 mm y 10 mm.
Schlemm (30) de un ojo humano, en donde el radio es de entre aproximadamente 3 mm y 10 mm.
3. El dispositivo de stent según una cualquiera
de las reivindicaciones 1 y 2, caracterizado porque dicha
curva tiene un radio de aproximadamente
6 mm.
6 mm.
4. El dispositivo de stent según una cualquiera
de las reivindicaciones 1 y 2, caracterizado porque dicho
cuerpo (10) tiene un diámetro exterior de aproximadamente 0,3
mm.
5. El dispositivo de stent según una cualquiera
de las reivindicaciones 1 y 2, caracterizado porque dicho
cuerpo (10) tiene una longitud de aproximadamente 20 mm.
6. El dispositivo de stent según una cualquiera
de las reivindicaciones 1 y 2, caracterizado porque dicho
cuerpo (10) tiene una serie de fenestraciones (15) que permiten el
paso de fluido hacia el canal de
Schlemm (30).
Schlemm (30).
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US13103099P | 1999-04-26 | 1999-04-26 | |
US131030P | 1999-04-26 |
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ES00923622T Expired - Lifetime ES2237424T3 (es) | 1999-04-26 | 2000-04-26 | Dispositivo de derivacion y metodo para tratar el glaucoma. |
ES00928419T Expired - Lifetime ES2251999T3 (es) | 1999-04-26 | 2000-04-26 | Dispositivo de stent para tratar glaucoma. |
ES04018732T Expired - Lifetime ES2328570T3 (es) | 1999-04-26 | 2000-04-26 | Dispositivo de derivacion y metodo para tratar el glaucoma. |
ES09168509T Expired - Lifetime ES2378611T3 (es) | 1999-04-26 | 2000-04-26 | Dispositivo de derivación para tratar glaucoma |
ES10183760.7T Expired - Lifetime ES2609594T3 (es) | 1999-04-26 | 2000-04-26 | Dispositivo de drenaje para tratar el glaucoma |
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ES00923622T Expired - Lifetime ES2237424T3 (es) | 1999-04-26 | 2000-04-26 | Dispositivo de derivacion y metodo para tratar el glaucoma. |
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ES04018732T Expired - Lifetime ES2328570T3 (es) | 1999-04-26 | 2000-04-26 | Dispositivo de derivacion y metodo para tratar el glaucoma. |
ES09168509T Expired - Lifetime ES2378611T3 (es) | 1999-04-26 | 2000-04-26 | Dispositivo de derivación para tratar glaucoma |
ES10183760.7T Expired - Lifetime ES2609594T3 (es) | 1999-04-26 | 2000-04-26 | Dispositivo de drenaje para tratar el glaucoma |
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EP (9) | EP1173123A1 (es) |
JP (7) | JP3703721B2 (es) |
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CN (1) | CN1354642A (es) |
AT (5) | ATE380536T1 (es) |
AU (6) | AU767526B2 (es) |
BR (2) | BR0010055A (es) |
CA (5) | CA2648346C (es) |
CZ (2) | CZ20013823A3 (es) |
DE (4) | DE60042853D1 (es) |
ES (5) | ES2237424T3 (es) |
HK (2) | HK1041195B (es) |
HU (2) | HUP0201111A3 (es) |
IL (2) | IL146020A0 (es) |
MX (5) | MXPA01010830A (es) |
NO (6) | NO20015209L (es) |
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SK (2) | SK15402001A3 (es) |
TR (2) | TR200103097T2 (es) |
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Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6203513B1 (en) | 1997-11-20 | 2001-03-20 | Optonol Ltd. | Flow regulating implant, method of manufacture, and delivery device |
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