ES2322803T3 - Aparato para la expansion de un disco intervertebral. - Google Patents
Aparato para la expansion de un disco intervertebral. Download PDFInfo
- Publication number
- ES2322803T3 ES2322803T3 ES03790406T ES03790406T ES2322803T3 ES 2322803 T3 ES2322803 T3 ES 2322803T3 ES 03790406 T ES03790406 T ES 03790406T ES 03790406 T ES03790406 T ES 03790406T ES 2322803 T3 ES2322803 T3 ES 2322803T3
- Authority
- ES
- Spain
- Prior art keywords
- inflatable element
- biomaterial
- disc
- expansion
- quad
- 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
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Abstract
Dispositivo expansible para la expansión de un disco intervertebral que comprende: un catéter (526); un elemento (528) inflable montado sobre dicho catéter e insertable en una abertura dilatada en un anillo del disco intervertebral intacto y en un núcleo pulposo del disco; y un dispositivo (526) de inflado conectado al elemento inflable para el inflado controlable del elemento inflable dentro del núcleo pulposo sin eliminar nada del núcleo pulposo; teniendo dicho catéter un primer canal (531) y un segundo canal (532), caracterizado porque un fluido de inflado para inflar dicho elemento inflable puede evacuarse a través de dicho primer canal para desinflar dicho elemento inflable mientras que se inyecta un biomaterial en el núcleo pulposo a través del segundo canal.
Description
Aparato para la expansión de un disco
intervertebral.
La enfermedad degenerativa del disco (EDD)
conduce a la deshidratación del disco (disco negro), al colapso
gradual y por último a dolor de piernas y/o espalda. La fusión
intercorporal son las normas asistenciales actuales para la EDD. Es
deseable que este tratamiento de fase final se retrase tanto como
sea posible mediante la intervención temprana con enfoques menos
invasivos. El aumento del disco mediante inyección de un biomaterial
en el espacio del disco se ha propuesto previamente como
tratamiento temprano mínimamente invasivo para un disco degenerado.
Dependiendo del nivel de deshidratación y colapso, la inyección de
un biomaterial en el espacio del disco de un disco intacto (anillo
no comprometido sin roturas significativas y el núcleo pulposo
original todavía en su sitio) puede requerir una alta presión de
inyección y el volumen inyectable del biomaterial puede ser
limitado. La alta presión de inyección aumenta el riesgo global del
procedimiento incluyendo fuga, ruptura del disco, etc. El volumen
inyectable limitado reduce la eficacia del tratamiento y puede
requerir tratamientos múltiples para alcanzar resultados
deseables.
En métodos conocidos para la expansión de un
disco intervertebral, se realiza un corte en el anillo del disco y
se elimina tejido del disco para proporcionar un paso para la
inserción de un dispositivo de expansión, un material de expansión
o ambos. Además, se elimina el núcleo pulposo y se sustituye por el
material de expansión y/o el dispositivo de expansión. Además, la
degeneración del disco se acelera cuando se corta una abertura en
el anillo del disco y se elimina tejido.
El documento WO 02/17825 da a conocer un
dispositivo de expansión de catéter de balón, según el preámbulo de
la reivindicación 1.
Lo que se necesita es un dispositivo y un método
para acceder al núcleo pulposo para la expansión del disco de modo
que no se elimine ninguna parte del anillo del disco ni del núcleo
pulposo. Además, lo que se necesita es un aparato y un método para
el tratamiento del disco mínimamente invasivo que aumente el volumen
inyectable a una presión inferior.
Por consiguiente, en un aspecto, la invención
proporciona un dispositivo expansible para la expansión de un disco
intervertebral que comprende: un catéter, un elemento inflable
montado sobre dicho catéter e insertable en una abertura dilatada
en un anillo del disco intervertebral intacto y en un núcleo pulposo
del disco; y un dispositivo de inflado conectado al elemento
inflable para el inflado controlable del elemento inflable dentro
del núcleo pulposo sin eliminar nada del núcleo pulposo; dicho
catéter tiene un primer canal y un segundo canal mediante los
cuales un fluido de inflado para inflar dicho elemento inflable
puede evacuarse a través de dicho primer canal para desinflar dicho
elemento inflable mientras que se inyecta un biomaterial en el
núcleo pulposo a través del segundo canal.
En otra realización, la invención proporciona un
sistema que incluye un dispositivo de este tipo, según la
reivindicación 14.
Una ventaja principal de esta realización es que
permite la expansión de un disco con un enfoque percutáneo o
mínimamente invasivo. La expansión del disco permite un volumen
mayor de inyección de biomaterial por tratamiento. Un volumen mayor
de inyección de biomaterial reduce el número de tratamientos para
alcanzar el nivel deseado de aumento. Este tratamiento permite la
expansión del disco sin eliminación del núcleo pulposo y ayuda a
determinar el volumen de biomaterial apropiado antes de la
inyección. La sobreinyección del disco, y las complicaciones y el
dolor resultantes, pueden minimizarse usando el dispositivo y el
método propuestos. Otra ventaja es que el disco permanece intacto
de modo que no se elimina ninguna parte del anillo del disco ni del
núcleo del disco.
Ahora se describirán realizaciones preferidas,
sólo a modo de ejemplo, con referencia a los dibujos.
La figura 1 es una vista en sección transversal
que ilustra una realización de una estructura de disco.
Las figuras 2A-2F son vistas en
sección transversal que ilustran una realización de un aparato y un
método de expansión de un disco, que no entra dentro de la
reivindicación 1.
La figura 3 es una vista en sección transversal
que ilustra otra realización de un aparato y un método de expansión
de un disco, que no entra dentro de la reivindicación 1.
La figura 4 es una vista en sección transversal
que ilustra otra realización de un aparato y un método de expansión
de un disco, que no entra dentro de la reivindicación 1.
Las figuras 5A-5D son vistas en
sección transversal que ilustran otra realización de un aparato y un
método de expansión de un disco, según la invención.
Una estructura 10 de disco, en la figura 1,
comprende generalmente las vértebras 12 y 14 adyacentes de las
regiones cervical, torácica o lumbar de la columna vertebral. Un
disco 16 intervertebral facilita el movimiento entre las vértebras
12 y 14 al tiempo que absorbe el impacto y distribuye las cargas. El
disco 16 comprende generalmente un núcleo central blando, es decir
el núcleo 18 pulposo (núcleo del disco), que soporta la mayor parte
de la carga en un disco sano, y un anillo externo duro, es decir el
anillo 20 fibroso (anillo del disco), que rodea y estabiliza el
núcleo 18 del disco. Hay un par de platillos 22 de cartílago entre
cada vértebra 12 y 14 respectiva, y el núcleo del disco.
El método y el aparato se usan siguiendo un
diagnóstico del paciente y la selección del tratamiento, y además,
un discograma para garantizar la integridad del anillo del
disco.
Se perfora el anillo 20 del disco, en la figura
2A, en 21 usando una aguja 24 de diámetro pequeño. Un tamaño de
aguja preferido es de calibre 20. Se introduce un catéter 26 de
balón de alta presión de diámetro pequeño (es decir, de 1 a 3 mm),
en la figura 2B, a través de la punción 21 en el anillo 20 del
disco. La ubicación de un balón 28 unido al catéter 26, en el
núcleo 18 del disco puede verificarse usando fluoroscopia. La
punción requerida para la inserción de dispositivos para la
inyección y la expansión del disco es lo suficientemente pequeña,
es decir no superior a 3 mm, de modo que la punción puede cerrarse
completamente, o cerrarse suficientemente de modo que el
biomaterial inyectado permanecerá capturado. En el caso de
biomaterial que se establece en el espacio del disco tras la
inyección, se asegura la captura del biomaterial inyectado. El uso
de un dispositivo de cierre del anillo tal como un tapón o de
material tal como un sellante, es opcional.
El balón 28, en la figura 2C, se infla
gradualmente con una solución salina y/o un medio de contraste
radiográfico tal como disolución de diatrizoato de sodio vendida
bajo la marca comercial Hypaque®, al tiempo que se monitoriza la
presión interna del balón con un manómetro de presión bien conocido.
La expansión del balón 28 se monitoriza usando fluoroscopia. La
tasa de inflado y el diseño, el tamaño o la forma del balón 28
pueden variarse entre pacientes dependiendo del estado del disco. A
medida que aumenta la presión intradiscal y/o se separan los
platillos 22 por el balón 28, se espera que el anillo 20 del disco
se estire, ya que es un material viscoelástico. El balón puede
permanecer inflado desde aproximadamente 1 minuto hasta
aproximadamente 1 hora, que puede variarse para cada paciente. Si
se requiere una expansión significativa, el balón puede permanecer
inflado hasta 4 horas o puede dejarse en el espacio del disco como
un implante temporal hasta 10 semanas.
A medida que se desinfla el balón 28, en la
figura 2D, el disco 16 se vuelve flácido con un espacio aumentado y
una presión intradiscal reducida. Puede suministrarse biomaterial 29
inyectable tal como un gel de colágeno al núcleo 18 del disco, en
la figura 2E, a través del mismo catéter. Ya que se usa el mismo
catéter para la inyección, la inyección puede realizarse
simultáneamente a medida que se desinfla el balón 28, tal como se
tratará a continuación en mayor detalle.
Ejemplos de biomateriales 29 que pueden usarse
para el aumento de un disco pueden ser naturales o sintéticos,
reabsorbibles o no reabsorbibles. Los materiales naturales incluyen
diversas formas de colágeno que se derivan de tejidos conjuntivos o
ricos en colágeno tales como un disco intervertebral, aponeurosis,
ligamento, tendón, piel, matriz ósea desmineralizada, etc. Las
fuentes de material incluyen autoinjerto, aloinjerto, xenoinjerto,
origen recombinante humano, etc. Los materiales naturales también
incluyen diversas formas de polisacáridos que se derivan de
animales o plantas tales como ácido hialurónico, quitosano,
celulosa, agar, etc. Otros materiales naturales incluyen otras
proteínas tales como fibrina, albúmina, seda, elastina y queratina.
Los materiales sintéticos incluyen diversos hidrogeles o polímeros
implantables tales como la silicona, poliuretano, copolímeros de
silicona-poliuretano, poliolefina, poliéster,
poliacrilamida, poli(ácido acrílico), poli(alcohol vinílico),
poli(óxido de etileno), polietilenglicol, polilactida,
poliglicolida,
poli(lactida-co-glicolida),
polidioxanona,
poli(\varepsilon-caprolactona),
polihidroxibutirato, polihidroxivalerato, policarbonato a base de
tirosina, poli(fumarato de propileno) o combinaciones de los
mismos. Se prefiere que el biomaterial pueda someterse a transición
desde un estado fluido hasta uno no fluido poco después de la
inyección. Esto puede lograrse normalmente añadiendo un agente de
reticulación al biomaterial antes, durante o tras la
inyección.
inyección.
También pueden incluirse proteoglucanos en el
biomaterial 29 inyectable para atraer y/o unir agua para mantener
el núcleo 18 del disco hidratado. De manera similar, también pueden
incluirse factores de crecimiento (por ejemplo factor de
crecimiento transformante beta, proteínas morfogenéticas óseas,
factores de crecimiento de fibroblastos, factores de crecimiento
derivados de plaquetas, factores de crecimiento de tipo insulina,
etc.) y/u otras células (por ejemplo, células de disco
intervertebral, células madre, etc.) para promover la curación,
reparación, regeneración y/o restauración del disco, y/o para
facilitar la función del disco apropiada. Los expertos en la
técnica conocen aditivos apropiados para su uso en la invención
reivindicada y pueden seleccionarse sin experimentación
excesiva.
El biomaterial 29 inyectable se mezcla
preferiblemente con el medio de contraste radiográfico antes de la
inyección en el núcleo 18 del disco. Esto permitirá monitorizar la
inyección usando fluoroscopia. El catéter 26 o la aguja 30, en la
figura 2F, usados para la inyección, se retiran tras depositarse un
volumen apropiado de biomaterial en el núcleo 18 del disco. Como
alternativa a la extracción del balón 28, tal como se ilustra en la
figura 2D anterior, un balón 128, en la figura 3, puede ser
desmontable en 127 desde un catéter 126, y puede permanecer inflado
en el núcleo 18 del disco como un implante. En el caso del balón 128
desmontable, puede ser ventajoso inyectar un biomaterial que tras
la inyección se adapta en forma elástica o de gel. Esto puede
realizarse inyectando un segundo material con el biomaterial que
modificará la forma del material inyectado.
En el caso de la inyección directa de
biomaterial 29 en el elemento 28 de balón inflable, el balón 28
puede ser poroso o permeable (por ejemplo material textil tejido,
estructura de malla, membrana perforada, etc.) para permitir la
migración de material o fluido hacia fuera del elemento inflable
durante o tras la inyección.
Alternativamente, un balón 28a modificado, en la
figura 4, puede ser de una forma que incluye un perfilador para
inflarse en un diseño para separar los platillos 22. Es decir, el
balón 28a se fabrica para expandirse hasta una forma adecuada para
realizar mejor la separación de los platillos 22 más que para
ajustarse a la forma del núcleo 18 del disco como en la figura 2C.
El catéter de balón según la invención es un catéter de doble luz
que puede usarse para la inyección a medida que se desinfla el
balón. En una realización, la figura 5A ilustra un catéter 526 de
balón introducido en el núcleo 18 del disco. El catéter 526 incluye
un primer canal 531, un segundo canal 532 y un balón 528. Se
inyecta la solución salina y/o el medio de contraste radiográfico
en el balón 528 a través del primer canal 531 pata inflar el balón
para la expansión del núcleo 18 del disco. En la figura 5B, el
balón 528 inflado permanece inflado en el núcleo 18 del disco
durante una cantidad de tiempo apropiada para estirar el anillo
fibroso y/o expandir el espacio del disco nuclear. En la figura 5C,
se inyecta un biomaterial 29 apropiado en el núcleo 18 del disco a
través del segundo canal 532 en el catéter 526 mientras que el
medio que infla al balón se evacua simultáneamente a través del
primer canal 531. En la figura 5D, el balón 528 desinflado se
extrae con el catéter 526 desde el núcleo 18 del disco y el
biomaterial 29 inyectado permanece dentro del núcleo 18 del
disco.
Como resultado, una realización proporciona un
aparato que incluye un catéter de balón de alta presión con un
diámetro de cuerpo pequeño (3 mm o menor, preferiblemente 2 mm o
menor, lo más preferiblemente 1 mm o menor). El catéter tiene una
punta puntiaguda para perforar un anillo de un disco intacto y la
inserción de la sección del balón en la región del disco nuclear.
El catéter o bien tiene un cuerpo rígido o bien está soportado por
una aguja guía rígida durante la penetración en el disco. Para un
cuerpo rígido, el catéter puede estar hecho de tubo de metal. Para
un cuerpo flexible, el catéter puede estar hecho de tubo polimérico
y está soportado con una agua guía o un cable guía rígidos. Si se
usa una aguja guía, el catéter puede ser de doble luz. El balón
tiene un volumen final apropiado de desde aproximadamente 0,1 cc
hasta aproximadamente 8,0 cc, preferiblemente hasta 5,0 cc y
dimensiones (longitud = 5-40 mm, preferiblemente
10-30 mm; diámetro = 3-20 mm,
preferiblemente 5-15 mm) para ajustar la región del
disco nuclear. El balón puede ser de diversas formas; cónica,
esférica, cuadrada, cónica larga, esférica larga, cuadrada larga,
afilada, escalonada, en forma de diábolo, inclinada o combinaciones
de las mismas. Los balones pueden hacerse de diversos materiales
poliméricos tales como poli(tereftalatos de etileno),
poliolefinas, poliuretanos, nailon, poli(cloruro de vinilo),
silicona, polieteretercetona, polilactida, poliglicolida,
poli(lactida-co-glicolida),
polidioxanona,
poli(\varepsilon-caprolactona),
polihidroxibutirato, polihidroxivalerato, policarbonato a base de
tirosina, poli(fumarato de propileno) o combinaciones de los
mismos.
Un ejemplo comparativo proporciona en primer
lugar una determinación de que el disco tratado tiene un anillo
fibroso intacto y competente para la expansión segura y la
contención eficaz del biomaterial inyectado posteriormente. Tras
verificar la integridad y la calidad del anillo usando una
discografía, el dispositivo de expansión del disco con el menor
diámetro de cuerpo posible se inserta en el centro del disco. La
inserción del dispositivo puede realizarse por vía percutánea,
preferiblemente con orientación fluoroscópica. El balón se infla
gradualmente con solución salina o fluido de radiocontraste para
presurizar el disco, y estirar de ese modo el anillo fibroso. Tras
un tiempo de inflado predeterminado, se desinfla el balón y se
retira del espacio del disco.
Puesto que se emplea un catéter de doble luz, el
biomaterial puede inyectarse en el disco a través del mismo catéter
durante o tras el desinflado del balón. El procedimiento completo se
realiza preferiblemente con orientación fluoroscópica.
Lo anterior ha descrito un aparato para la
expansión de un disco intervertebral antes de su aumento con un
biomaterial inyectable. La expansión del disco prepara el anillo del
disco para alojar un volumen eficaz o deseable del material
inyectable en un único tratamiento. Debido a que el anillo fibroso
es un material viscoelástico, puede estirarse temporalmente a
medida que el disco se expande a presión.
Claims (17)
1. Dispositivo expansible para la expansión de
un disco intervertebral que comprende:
- \quad
- un catéter (526);
- \quad
- un elemento (528) inflable montado sobre dicho catéter e insertable en una abertura dilatada en un anillo del disco intervertebral intacto y en un núcleo pulposo del disco; y
- \quad
- un dispositivo (526) de inflado conectado al elemento inflable para el inflado controlable del elemento inflable dentro del núcleo pulposo sin eliminar nada del núcleo pulposo; teniendo dicho catéter un primer canal (531) y un segundo canal (532), caracterizado porque un fluido de inflado para inflar dicho elemento inflable puede evacuarse a través de dicho primer canal para desinflar dicho elemento inflable mientras que se inyecta un biomaterial en el núcleo pulposo a través del segundo canal.
2. Dispositivo expansible según la
reivindicación 1, en el que el elemento inflable tiene una forma
expandida controlada que se ajusta sustancialmente a la forma del
núcleo pulposo.
3. Dispositivo expansible según la
reivindicación 2, en el que el elemento inflable tiene un volumen
inflado de desde 0,1 cc hasta 8,0 cc.
4. Dispositivo expansible según cualquier
reivindicación anterior, que comprende además:
un perfilador formado en el elemento inflable y
conformado para separar platillos vertebrales en respuesta a la
expansión del elemento inflable.
5. Dispositivo según la reivindicación 1, en el
que el biomaterial se proporciona como una formulación que incluye
factores de crecimiento.
6. Dispositivo según la reivindicación 1, en el
que el biomaterial se proporciona como una formulación que incluye
uno o más tipos de células eficaces para promover la curación,
reparación, regeneración y/o restauración del disco, y/o para
facilitar la función del disco apropiada.
7. Dispositivo según la reivindicación 1, en el
que el biomaterial se modifica desde un estado fluido hasta un
estado no fluido tras el inflado del elemento inflable.
8. Dispositivo según la reivindicación 7, en el
que el biomaterial es un material sintético.
9. Dispositivo según la reivindicación 8, en el
que el material sintético es un polímero.
10. Dispositivo según la reivindicación 8, en el
que el material sintético es un hidrogel.
11. Dispositivo según la reivindicación 1, en el
que el biomaterial es un material natural.
12. Dispositivo según la reivindicación 11, en
el que el material natural es un material de colágeno.
13. Dispositivo según la reivindicación 11, en
el que el material natural es un material de polisacárido.
14. Sistema de expansión e inyección para un
disco intervertebral que comprende un dispositivo expansible según
cualquier reivindicación anterior, y que comprende además:
- \quad
- un instrumento para formar y dilatar una abertura en el anillo del disco sin eliminar nada del anillo del disco;
- \quad
- un manómetro para monitorizar la presión del elemento inflable;
- \quad
- medios para desinflar el elemento inflable; y
- \quad
- un instrumento (30) de inyección para inyectar el biomaterial en el espacio aumentado.
15. Sistema según la reivindicación 14, en el
que el elemento (28) inflable está adaptado de modo que su ubicación
se verifica mediante fluoroscopia.
16. Sistema según la reivindicación 14, en el
que el elemento (28) inflable está adaptado para inflarse con un
material de radiocontraste.
17. Sistema según la reivindicación 14, en el
que el elemento inflable está adaptado de modo que su expansión se
monitoriza mediante fluoroscopia.
Applications Claiming Priority (2)
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|---|---|---|---|
| US314396 | 2002-12-07 | ||
| US10/314,396 US20040186471A1 (en) | 2002-12-07 | 2002-12-07 | Method and apparatus for intervertebral disc expansion |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2322803T3 true ES2322803T3 (es) | 2009-06-29 |
Family
ID=32505855
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES03790406T Expired - Lifetime ES2322803T3 (es) | 2002-12-07 | 2003-12-08 | Aparato para la expansion de un disco intervertebral. |
Country Status (9)
| Country | Link |
|---|---|
| US (2) | US20040186471A1 (es) |
| EP (1) | EP1575458B1 (es) |
| JP (1) | JP4456002B2 (es) |
| AT (1) | ATE423531T1 (es) |
| AU (1) | AU2003293455A1 (es) |
| CA (1) | CA2508435A1 (es) |
| DE (1) | DE60326386D1 (es) |
| ES (1) | ES2322803T3 (es) |
| WO (1) | WO2004052248A1 (es) |
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2003
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- 2003-12-08 CA CA002508435A patent/CA2508435A1/en not_active Abandoned
- 2003-12-08 EP EP03790406A patent/EP1575458B1/en not_active Expired - Lifetime
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2007
- 2007-10-25 US US11/924,026 patent/US20080091167A1/en not_active Abandoned
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| JP4456002B2 (ja) | 2010-04-28 |
| US20080091167A1 (en) | 2008-04-17 |
| EP1575458A1 (en) | 2005-09-21 |
| CA2508435A1 (en) | 2004-06-24 |
| US20040186471A1 (en) | 2004-09-23 |
| ATE423531T1 (de) | 2009-03-15 |
| AU2003293455A1 (en) | 2004-06-30 |
| DE60326386D1 (de) | 2009-04-09 |
| JP2006508771A (ja) | 2006-03-16 |
| WO2004052248A1 (en) | 2004-06-24 |
| EP1575458B1 (en) | 2009-02-25 |
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