ES2217796T3 - Separador de injerto intervertebral. - Google Patents
Separador de injerto intervertebral.Info
- Publication number
- ES2217796T3 ES2217796T3 ES99940102T ES99940102T ES2217796T3 ES 2217796 T3 ES2217796 T3 ES 2217796T3 ES 99940102 T ES99940102 T ES 99940102T ES 99940102 T ES99940102 T ES 99940102T ES 2217796 T3 ES2217796 T3 ES 2217796T3
- Authority
- ES
- Spain
- Prior art keywords
- implant
- implant according
- bone
- separator
- parts
- 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
- 239000007943 implant Substances 0.000 claims abstract description 155
- 210000000988 bone and bone Anatomy 0.000 claims abstract description 31
- 239000000463 material Substances 0.000 claims description 8
- 229910052736 halogen Inorganic materials 0.000 claims description 7
- 150000002367 halogens Chemical class 0.000 claims description 7
- 238000002513 implantation Methods 0.000 claims description 7
- 230000000278 osteoconductive effect Effects 0.000 claims description 4
- 239000012634 fragment Substances 0.000 claims description 3
- 230000013011 mating Effects 0.000 claims 1
- 230000004927 fusion Effects 0.000 abstract description 6
- 238000000034 method Methods 0.000 description 10
- 210000005036 nerve Anatomy 0.000 description 8
- 210000004705 lumbosacral region Anatomy 0.000 description 6
- 102100020760 Ferritin heavy chain Human genes 0.000 description 5
- 101001002987 Homo sapiens Ferritin heavy chain Proteins 0.000 description 5
- 238000003780 insertion Methods 0.000 description 5
- 230000037431 insertion Effects 0.000 description 5
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 4
- 239000004020 conductor Substances 0.000 description 4
- 238000000926 separation method Methods 0.000 description 4
- 239000010936 titanium Substances 0.000 description 4
- 229910052719 titanium Inorganic materials 0.000 description 4
- 230000015572 biosynthetic process Effects 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- 208000007623 Lordosis Diseases 0.000 description 2
- 210000003484 anatomy Anatomy 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
- 210000001951 dura mater Anatomy 0.000 description 2
- 238000002594 fluoroscopy Methods 0.000 description 2
- 238000003801 milling Methods 0.000 description 2
- 230000011164 ossification Effects 0.000 description 2
- 230000002035 prolonged effect Effects 0.000 description 2
- 210000000278 spinal cord Anatomy 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 210000000115 thoracic cavity Anatomy 0.000 description 2
- 238000012876 topography Methods 0.000 description 2
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 description 1
- 208000008930 Low Back Pain Diseases 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 208000007103 Spondylolisthesis Diseases 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 230000000735 allogeneic effect Effects 0.000 description 1
- 239000000427 antigen Substances 0.000 description 1
- 102000036639 antigens Human genes 0.000 description 1
- 108091007433 antigens Proteins 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 208000037873 arthrodesis Diseases 0.000 description 1
- 230000002146 bilateral effect Effects 0.000 description 1
- 239000000316 bone substitute Substances 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 230000008105 immune reaction Effects 0.000 description 1
- 238000002357 laparoscopic surgery Methods 0.000 description 1
- 230000005923 long-lasting effect Effects 0.000 description 1
- 230000001045 lordotic effect Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 230000003278 mimic effect Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 208000015122 neurodegenerative disease Diseases 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 230000037390 scarring Effects 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 125000006850 spacer group Chemical group 0.000 description 1
- 210000005065 subchondral bone plate Anatomy 0.000 description 1
- 239000002344 surface layer Substances 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
- B29C43/006—Pressing and sintering powders, granules or fibres
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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
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/4465—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract
Implante (10, 40, 50 70, 80) comprendiendo una porción de hueso alógeno y teniendo una pluralidad de paredes laterales planas o curvas (18, 22, 26, 28), una superficie superior (14) y una superficie inferior (16) con el fin de ajustarse como un injerto entre las superficies del hueso o de los fragmentos de huesos adyacentes, caracterizado porque A) las dichas superficies superior e inferior (14, 16) están provistas de una estructura en tres dimensiones para interconectarse con dichas superficies de hueso o de fragmentos de hueso adyacentes, y porque B) dicho implante (10, 40, 50, 70, 80) esta combinado con un separador discreto (120) comprendiendo una porción de tejido oseó alógeno conformada en tamaño y forma con una parte de un placa vertebral y teniendo un perfil en forma acuñada, en el cual las superficies superior e inferior (14, 16) de dicho separador (120) son sensiblemente lisas y el pasaje entre las superficies superior e inferior y los lados anterior (26) y laterales (18, 22) del separador tiene lugar por los bordes curvos (30) para facilitar la implantación del separador (120).
Description
Separador de injerto intervertebral.
La presente invención esta dirigida a un implante
alógeno de acuerdo con la definición de la reivindicación 1. La
misma hace referencia mas particularmente a un implante alógeno
intervertebral en correspondencia en tamaño y en forma con las
placas extremas de las vértebras.
Un determinado número de condiciones médicas como
una compresión de las raíces nerviosas de la medula espinal,
enfermedades degenerativas de los discos y la espondilolistesis
pueden provocar dolores severos en la parte inferior de la espalda.
La fusión intervertebral es un procedimiento quirúrgico para reducir
el dolor en la parte inferior de la espalda. En una fusión
intervertebral lumbar posterior ("PLIF") dos cuerpos de
vértebras adyacentes son fusionados juntos mediante la retirada del
disco afectado y la inserción de un implante que permitirá al hueso
crecer entre los dos cuerpos vertebrales para cubrir la separación
dejada por la retirada del disco.
Un determinado número de diferentes implantes y
de materiales de implante han sido utilizados en el procedimiento
PLIF con un éxito variable. Los implantes utilizados actualmente
para el PLIF comprenden unas cajas en titanio roscadas y los
injertos. Las cajas en titanio roscadas presentan el inconveniente
de tener que agujerear y taladrar las placas vertebrales extremas
para las finalidades de inserción. Además, la incidencia de una
compresión durante un uso prolongado no es conocida. Debido a la
incompatibilidad del titanio con el IRM, la fusión es difícil de
determinar. Finalmente, la restauración de la lordosis, es decir la
curvatura natural de la columna lumbar, es muy difícil cuando se
utiliza una caja cilíndrica en titanio.
Los injertos son secciones de hueso efectuadas en
un hueso largo de un donante. Una sección transversal del hueso es
efectuada y tratada utilizando las técnicas conocidas para
preservar el injerto hasta la implantación y reducir el riesgo de
una reacción inmunológica negativa cuando el mismo es implantado.
Por ejemplo, la patente US nº 4 678.470 divulga un procedimiento
para tratar un material de injerto óseo que utiliza el curtido al
glutaraldehido para producir un material no antígeno
bio-compatible. Los injertos tienen propiedades
mecánicas que son similares al blindaje que tiene lugar con los
implantes metálicos. Los mismos son también compatibles con el IRM
de forma que es posible el asegurar más precisamente la fusión y
favorecer la formación ósea, es decir la osteoconductividad. Aun
cuando la naturaleza osteoconductora del injerto suministra una
interconexión biológica entre el injerto y las vértebras para una
resistencia mecánica de larga duración, la resistencia mecánica
inicial y a corto plazo la resistencia mecánica de la superficie de
contacto entre el injerto y las vértebras fueron defectuosas como
lo prueba la posibilidad de que el injerto sea expulsado después de
la implantación.
Los injertos actualmente disponibles en el
comercio son simplemente secciones de hueso que no están
específicamente destinadas a ser utilizados en el procedimiento
PLIF. Por consiguiente, la fusión de los cuerpos vertebrales no
tiene lugar en una posición anatómica óptima. Un cirujano puede
proceder a una determinada colocación en forma y en dimensión
intra-operatoria mínima para adaptar el injerto a
la anatomía espinal del paciente. Sin embargo, una importante
adaptación en forma y dimensión no es posible por razón de la
naturaleza del injerto. Incluso si una colocación en forma y en
dimensión extensiva fuera posible, la capacidad de un cirujano para
colocar el injerto manualmente en la forma y en las dimensiones
deseadas esta severamente limitada.
La mayoría de los implantes PLIF, tanto se trate
de cajas roscadas o un injerto, están disponibles en diferentes
tamaños y tienen longitudes que varían en función de la altura del
implante. Por ejemplo, la longitud de una caja cilíndrica será
sensiblemente equivalente a la altura del implante. Aunque las
alturas más grandes pueden ser clínicamente indicadas, los implantes
más grandes no son en general deseados, teniendo en cuenta que una
anchura incrementada requiere la retirada de una parte más grande
de la cara, lo que puede arrastrar a una disminución de la
estabilidad y una retracción más grande de las raíces de los
nervios, lo cual puede conducir a un daño temporal o permanente de
los nervios.
Se conoce por la patente US-A 5
514 180 concedida a HEGGENESS ET AL. Un dispositivo
intervertebral protético bajo la forma de un simple cuerpo
cilíndrico teniendo unas paredes laterales curvadas y unas
superficies superior e inferior lisas con el fin de adaptarse entre
las superficies de las vértebras adyacentes. Este implante conocido
puede comprender unas secciones de injerto sin divulgar los
detalles de una tal forma de realización.
Como ilustra la argumentación anterior, se tiene
necesidad de un implante mejor para fusionar las vértebras.
La invención resuelve el problema propuesto con
un implante que presenta las características de la reivindicación
1. Realizaciones ventajosas adicionales de la invención están
caracterizadas en las sub-reivindicaciones.
La presente invención hace referencia a un
implante intervertebral alógeno para utilización cuando la fusión
quirúrgica de los cuerpos vertebrales esta indicada. En una forma
de realización, el implante comprende una porción de hueso alógeno
en correspondencia de tamaño y forma con una parte de las placas
vertebrales y que tiene un perfil en forma de cuña con una
pluralidad de dientes situados sobre las superficies superior e
inferior. Las superficies superior e inferior pueden ser unas
superficies de placas lisas planas o curvas para imitar la
topografía de las placas extremas. El implante tiene un canal sobre
al menos un lado para recibir una herramienta quirúrgica. Este
canal se desplaza en la dirección anterior para aceptar una
variedad de aproximaciones quirúrgicas. Un orificio roscado sobre el
lado anterior, posterior, posterior-lateral o
lateral puede estar previsto para recibir un brazo roscado de una
herramienta de inserción.
En una otra forma de realización, el implante
tiene un espacio interior para recibir un material
osteo-conductor destinado a favorecer la formación
de un hueso nuevo.
En otra forma de realización, el implante esta
hecho en dos mitades; una parte superior teniendo una superficie de
conexión superior y una parte inferior teniendo una superficie de
conexión inferior. La superficie de conexión superior se acopla con
la superficie de conexión inferior cuando las partes superior e
inferior son unidas. Las partes superior e inferior tienen unos
orificios que se alinean para recibir un pasador con el fin de
asegurar las partes superior e inferior. El pasador puede estar
hecho de un hueso alógeno.
En una forma de realización suplementaria, el
lado medio del implante tiene un canto escotado de forma que,
cuando un primer implante es implantado con un segundo implante con
los lados medios enfrentados entre sí, los bordes escotados definen
un espacio cilíndrico.
La presente invención hace referencia también a
un separador discreto utilizado con una cualquiera de las otras
formas de realización del implante. En una forma de realización, el
separador comprende una porción de hueso alógeno de conformidad en
tamaño y forma con una parte de las placas vertebrales extremas y
un perfil en forma de cuña con las superficies superior e inferior
sensiblemente lisas. Las regiones de intersección entre las
superficies superior e inferior y al menos dos lados laterales y la
región de intersección entre los lados anterior y posterior y el
mismo lado lateral tienen unas superficies curvas para facilitar la
implantación del separador. Por consiguiente, el separador podría
ser implantado por una abertura sobre un lado del canal raquídeo y
desplazado con un instrumento quirúrgico hacia el lado opuesto.
La invención y las formas de realización
suplementarias de la invención son explicadas de una forma todavía
más detallada haciendo referencia a la ilustración en parte
esquemática de las formas de realización.
En las figuras:
La Figura 1, es una vista en planta superior de
una primera realización del implante de acuerdo con la
invención;
La Figura 2, es una vista lateral del implante de
la figura 1,
La Figura 3, es una vista posterior del implante
de la Figura 1.
La Figura 4, es una vista en planta superior de
una segunda forma de realización del implante,
La Figura 5, es una vista lateral del implante de
la figura 4.
La Figura 6, es una vista en planta superior de
una tercera forma de realización del implante;
La Figura 7, es una vista lateral del implante de
la figura 6,
La Figura 8A, es una vista en planta superior de
una superficie de conexión superior de una parte superior del
implante de la figura 6,
La Figura 8B, es una vista en planta superior de
una superficie de conexión inferior de una parte inferior del
implante de la figura 6,
La Figura 9, es una vista en perspectiva de una
cuarta forma de realización del implante,
La Figura 10A, es una vista lateral de una forma
de realización del dentado del implante,
La Figura 10B, es una vista lateral de una
segunda forma de realización del dentado del implante,
La Figura 11, es una vista lateral de una forma
de realización del implante similar a la realización de las figuras
6-8,
La Figura 12, es una vista en planta superior de
un hueso vertebral característico de aquellos de la columna
cervical, torácica o lumbar,
La Figura 13, es una vista lateral de los huesos
vertebrales alineados secuencialmente, tales como los que se
encuentran en la columna cervical, torácica o lumbar.
La Figura 14, es una vista posterior de una
secuencia de vértebras, y
La Figura 15, es una vista del extremo de otra
forma de realización del implante.
La Figura 1, muestra una vista en planta superior
de una primera forma de realización de un separador de injerto
intervertebral o de un implante (10) de acuerdo con la presente
invención. El implante (10) de conformidad en tamaño y en forma con
una parte de las placas vertebrales extremas entre las cuales el
implante (10) será implantado. Como el implante (10) es un injerto,
el implante (10) favorece la formación de un nuevo hueso para
fusionar los dos cuerpos vertebrales juntos. Aunque el implante
(10) sea susceptible de ser utilizado de forma predominante en la
región lumbar de la columna, el implante (10) puede ser configurado
para la implantación en cualquier región de la columna. El implante
tiene una pluralidad de dientes (12) sobre las superficies superior
e inferior (14), (16) que suministran una interconexión mecánica
entre el implante y las placas extremas. Los dientes (12)
suministran la interconexión mecánica penetrando en las placas
extremas. La estabilidad mecánica inicial suministrada por los
dientes (12) minimiza el riesgo de expulsión postoperatoria del
implante (10). Los dientes pueden ser de forma piramidal (Figura
10A). Preferiblemente, el ángulo formado desde la punta a la base
es aproximadamente de 60º. Alternativamente, los dientes (12)
tienen una forma en diente de sierra con el diente de la sierra
desplazándose en el sentido antero-posterior (Figura
10B).
Como lo muestran las figuras 2 y 3, un primer
lado lateral (18) tiene un canal (20) y un segundo lado lateral
(22) tiene también un canal (20). Los canales (20) están
dimensionados para recibir un instrumento quirúrgico como un
injertador para implantar el implante (10). Si el injertador tiene
un brazo fileteado, el implante (10) puede estar provisto de un
orificio fileteado (24). En la figura 2, el canal (20) es mostrado
como prolongado solamente en parte a lo largo de un primer lado
lateral (18). El canal (20) puede extenderse a lo largo de toda la
longitud del primer lado lateral (18) como es mostrado en la forma
de realización de la figura 5. En la figura 3, los canales (20)
están mostrados sobre el primer y el segundo lado lateral (18),
(22). Es de señalar que el implante (10) puede también no tener
ningún canal o no tener canal más que sobre un lado lateral como
muestra la forma de realización de la figura 9.
Las dimensiones del implante (10) pueden variar
para adaptarse a la anatomía de un paciente. De forma típica, el
implante (10) tendría una anchura entre 6 y 15 mm (en el sentido
medio-lateral), una longitud entre 15 y 30 mm (en el
sentido antero-posterior) y una altura entre 4 y 30
mm (altura máxima en el sentido superior-inferior).
El tamaño del implante (10) permite el implantar el implante (10)
utilizando los procedimientos convencionales de la cirugía abierta o
los procedimientos poco invasivos, como la cirugía por
laparoscopía. Adicionalmente, puesto que la anchura es mantenida en
una escala de tamaño restringida y no se incrementa necesariamente
con la altura del implante, unos implantes más grandes pueden ser
utilizados sin que los implantes más anchos sean necesarios. Por
consiguiente, la retirada de la cara y la retracción de las raíces
nerviosas pueden permanecer en un mínimo.
Con el fin de restaurar la curvatura natural de
la columna después de que el disco afectado ha sido retirado, el
implante (10) tiene un perfil en forma de cuña. Como se muestra en
la figura 2, esta forma de cuña da como resultado una disminución
gradual de la altura de un lado anterior (26) a un lado posterior
(28). En términos anatómicos, la curva natural de la columna lumbar
es designada por el termino lordosis. Cuando el implante (10) es
utilizado en la región lumbar, el ángulo formado por la cuña
debería de ser aproximadamente entre 4,2º y 15º con el fin de que
la forma de la cuña sea de una forma lordotica que imite a la
anatomía de la columna lumbar.
Con vistas a facilitar la inserción del implante
(10) el pasaje del lado anterior (26) a las superficies superior e
inferior (14), (16) se efectúa por los bordes redondeados (30). Los
bordes redondeados (30) permiten al implante (10) deslizarse entre
las placas extremas minimizando la distracción necesaria de las
placas extremas.
Aun cuando el implante (10) es típicamente una
pieza sólida de hueso alógeno, el implante (10) puede estar
provisto con un interior hueco para formar un espacio interior.
Este espacio interior puede ser rellenado de fragmentos de hueso o
de cualquier otro material osteo-conductor para
favorecer todavía más la formación de nuevo hueso.
La Figura 4, muestra una vista en planta superior
de una segunda forma de realización de un implante (40) de acuerdo
con la presente invención. En general la mayor parte de la
estructura del implante (40) es similar o comparable a la
estructura del implante (10). Por consiguiente, la discusión de los
componentes similares no se considera necesaria. Las superficies
superior e inferior (14), (16) del implante (10) son unas
superficies planas lisas. Como se ve mejor sobre la figura 5, las
superficies superior e inferior (14), (16) del implante (40) son
unas superficies curvas que conservan todavía el perfil en forma de
cuña. Las superficies curvas de las superficies superior e inferior
(14), (16) del implante (40) son una imagen espejo de la topografía
de las placas vertebrales. Por consiguiente, las superficies curvas
se conforman a los contornos de las placas extremas.
La Figura 6, muestra una vista en planta superior
de una tercera forma de realización de un implante (50) de acuerdo
con la presente invención. En general, la mayor parte de la
estructura del implante (50) es similar o comparable a la
estructura de los implantes (10), (40). Por consiguiente, la
discusión de los componentes similares no se considera necesaria.
Como se ve mejor sobre la figura 7, el implante (50) comprende una
parte superior (52) unida a una parte inferior (54). Como puede ser
difícil de obtener una sola sección de hueso alógeno a partir de la
cual el implante (50) será fabricado, la fabricación del implante
(50) en dos porciones, es decir la parte superior e inferior (52),
(54) permite el utilizar unas secciones más pequeñas de hueso
alógeno. Una superficie de conexión superior (56) y una superficie
de conexión inferior (58) definen la superficie de contacto entre
las partes superior e inferior (52), (54). Como muestran las
figuras 8A y 8B, las superficies superior e inferior (56), (58)
tienen unos nervios (60) que se acoplan con las ranuras (62) para
interconectar las partes superior e inferior (52), (54). Los nervios
(60) y las ranuras (62) son formados preferentemente, mediante
fresado de las superficies superior e inferior (56) (58) en una
primera dirección y a continuación fresando una segunda vez con las
superficies superior e inferior (56), (58) orientados a 90º con
respecto a la primera dirección.
Un pasador (64) pasando por unos orificios (56)
alineados en las partes superior e inferior (52), (54) sirve para
retener las porciones superior e inferior (52), (54) juntas. Aunque
el pasador (64) puede ser fabricado en no importa que material
bio-compatible, el pasador (64) esta hecho
preferentemente en hueso alógeno. El número y la orientación de los
pasadores (64) pueden variar.
La Figura 11, muestra una forma de realización de
un implante (80) que, como el implante (50), esta hecho de
múltiples piezas. En general, la mayor parte de la estructura del
implante (80) es similar o comparable a la estructura de los
implantes (10), (40) y (50). Por consiguiente, la discusión de los
componentes similares no se estima necesaria. El implante (80)
tiene una parte superior (82), una parte central (84) y una parte
inferior (86). Como era el caso para el implante (50) las
superficies entre las partes son unas superficies de acoplamiento
con unos elementos de superficie interconectandose, como unos
nervios y unas ranuras. Uno o varios pasadores mantienen
preferentemente juntas las partes superior central e inferior (82),
(84), (86).
La Figura 9, muestra una vista en perspectiva de
una cuarta realización de un primer implante (70) de acuerdo con la
presente invención. Un segundo implante (70) que es sensiblemente
similar al primer implante (70) es igualmente mostrado. En general,
la mayor parte de la estructura del primer y del segundo implante
(70), (70') es similar o comparable a la estructura de los implantes
(10), (40) (50). Por consiguiente, la discusión de los componentes
similares no se ha estimado necesaria. Los primeros lados laterales
(18) del primer y del segundo implante (70), (70') están escotados
para tener una forma en C. Cuando el primero y el segundo implante
(70), (70') son situados lado a lado con los primeros lados
laterales (18) encarados, un espacio cilíndrico (72) es formado.
Cuando el primer y el segundo implante (70), (70') son implantados
juntos, el espacio cilíndrico (72) es llenado de material
osteo-conductor para ayudar a favorecer la
formación del hueso nuevo. El primer y segundo implantes (70),
(70') pueden estar equipados con pasadores de enclavamiento (74) que
se encajan en las aberturas (76) para mantener la relación espacial
entre el primero y el segundo implantes (70), (70').
La utilización del implante de acuerdo con la
presente invención será a continuación descrita haciendo referencia
a las figuras (12), (14) y utilizando la artrodesis
inter-somática lumbar por vía posterior como
ejemplo. Como el implante de acuerdo con la presente invención se
encuentra en correspondencia en tamaño y forma a una porción de las
placas extremas (100) una planificación
pre-operatoria es recomendada para una toma de
dimensión adecuada. Es conveniente el determinar la altura
apropiada del implante midiendo los discos intervertebrales (102)
adyacentes sobre una radiografía lateral. El implante tiene que ser
asentado firmemente estando estrechamente ajustado entre las placas
(100) cuando el segmento es completamente distribuido. Es
conveniente el utilizar el implante más grande posible para
maximizar la estabilidad segmental. En razón de la variabilidad de
los grados de magnificación de las radiografías las medidas son
solamente una estimación.
Cuando el paciente esta en posición alargada
sobre un cuadro lumbar, el equipo radiográfico puede ayudar a
confirmar la posición intra-operatoria precisa del
implante. El cirujano incide y disecciona lateralmente la piel a
partir de una línea central y localiza la apófisis espinosa (104)
la lamina (106) la duramáter (108) y las raíces nerviosas a los
niveles apropiados. Conviene el preservar tanto como sea posible
las caras (110) para suministrar una estabilidad al segmento
intervertebral. El cirujano practica una laminotomía del aspecto
medial de la faceta (110) refleja la duramáter (108) para exponer
una ventana de aproximadamente 13 mm hacia el espacio del disco. El
disco (102) es retirado por la ventana hasta que solamente
permanece el anillo anterior (112) y el anillo lateral (114). Las
capas superficiales de la totalidad de las placas extremas (100)
cartilaginosas son igualmente retiradas para exponer el hueso. Una
retirada excesiva del hueso subchondral puede debilitar la columna
anterior. Además si la totalidad de la placa extrema es retirada,
esto puede dar como resultado un hundimiento y una perdida de
estabilidad segmental.
La separación puede ser efectuada por medio de un
separador quirúrgico o de un implante separador de ensayo. En el
primer procedimiento, las láminas del separador deben de ser
insertadas completamente en el espacio discal con el fin de que las
aristas en el extremo de las láminas descansen sobre el cuerpo
vertebral (116). La fluoroscopia puede ayudar a confirmar que las
lamas del separador son paralelas a las placas (100). La situación
correcta orientara las empuñaduras del separador cranealmente, en
particular en L5 - S1. La empuñadura del separador es presionada
para separar el espacio interior. La separación es asegurada
mediante la fijación de la tuerca rápida sobre la empuñadura.
Utilizando el tamaño determinado antes de la
operación, un separador de ensayo es insertado en el espacio discal
contra-lateral por impactación suave. La
fluoroscopía y el juicio por tacto pueden ayudar a confirmar el
ajuste del separador de ensayo hasta que un ajuste seguro es
alcanzado. Utilizando bien las hendiduras bien el orificio roscado
sobre el implante, el implante seleccionado es insertado en el
espacio discal contra-lateral. Alternativamente, los
canales sobre el implante permiten que la separación y la inserción
tengan lugar del mismo lado. Independientemente del lado en el cual
el implante es insertado, del tejido óseo reticulado autógeno o un
sustituto óseo debe de ser situado en el aspecto anterior y medial
del espacio discal vertebral antes de la colocación del segundo
implante. El separador es retirado y un segundo implante de la misma
altura que el primer implante es insertado en el espacio
recurriendo a una impactación suave como precedentemente. Los
implantes son preferentemente rebajados 2 - 4 mm más allá del borde
posterior del cuerpo vertebral.
Como se ha señalado precedentemente, el implante
de acuerdo con la presente invención puede ser insertado utilizando
unos procedimientos poco invasivos. En determinados de estos
procedimientos, solo un lado del cordón espinal debe de ser
aproximado. Esto minimiza la retirada muscular, el tejido
cicatricial en el canal y la retracción de las raíces nerviosas y
la manipulación. En las situaciones clínicas en las cuales el
emplazamiento bilateral de un implante es requerido, una
implantación correcta sobre el lado opuesto a la incisión puede ser
difícil. La Figura 15, muestra un separador achaflanado (120) que
facilita el emplazamiento sobre el lado
contra-lateral de la incisión. En general y a menos
que no sea descrito de otra forma, la mayor parte de la estructura
del separador achaflanado (120) es similar o comparable a la
estructura de los implantes (10), (40), (50) y (80). Por
consiguiente, la discusión de los componentes similares no se ha
estimado necesaria. Los pasajes del primer lado lateral (18) a los
lados anterior y posterior (26), (28) tienen lugar por los bordes
redondeados (30). Además el separador (120) no tiene dientes. La
ausencia de dientes y el borde redondeado (30) permiten al
separador (20) deslizarse entre la placa extrema y en el espacio
evacuado (de un anillo lateral al otro), hasta el lado
contra-lateral. El primer lado lateral (18) es el
lado que debe de favorecer el movimiento del separador (120).
Después de que el espaciador (120) ha sido situado contra el lado
contra-lateral con la única incisión utilizando un
instrumento quirúrgico para empujar el separador (120), un material
de injerto óseo u otro material osteo-conductor es
situado en el espacio discal. Finalmente, el implante (no importa
que implante 10, 40, 50, 70 ó 70' pueden ser utilizados), es
implantado en el lado proximal de la incisión.
Aun cuando es aparente que las formas de
realización ilustrativas de la invención divulgadas aquí
cumplimentan los objetivos mencionados anteriormente, será de
apreciar que numerosas modificaciones y otras formas de realización
pueden ser concebidas por las personas expertas en la técnica. Por
consiguiente, será evidente que el alcance de la presente invención
esta únicamente limitado por las reivindicaciones adjuntas.
Claims (26)
1. Implante (10, 40, 50, 70, 80) comprendiendo
una porción de hueso alógeno y teniendo una pluralidad de paredes
laterales planas o curvas (18, 22, 26, 28), una superficie superior
(14) y una superficie inferior (16) con el fin de ajustarse como un
injerto entre las superficies del hueso o de los fragmentos
de
huesos adyacentes,
huesos adyacentes,
caracterizado porque
A) las dichas superficies superior e inferior
(14, 16) están provistas de una estructura en tres dimensiones para
interconectarse con dichas superficies de hueso o de fragmentos de
hueso adyacentes, y por-
que
que
B) dicho implante (10, 40, 50, 70, 80) esta
combinado con un separador discreto (120) comprendiendo una porción
de tejido óseo alógeno conformada en tamaño y forma con una parte
de una placa vertebral y teniendo un perfil en forma acuñada, en el
cual las superficies superior e inferior (14, 16) de dicho
separador (120) son sensiblemente lisas y el pasaje entre las
superficies superior e inferior y los lados anterior (26) y
laterales (18, 22) del separador tiene lugar por los bordes curvos
(30) para facilitar la implantación del separador (120).
2. Implante de acuerdo con la Reivindicación 1,
caracterizado porque el implante (10, 40, 50, 70, 80) tiene
un perfil en forma acuñada.
3. Implante de acuerdo con las Reivindicaciones 1
ó 2, caracterizado porque al menos una pared lateral (18,
22, 26, 28) tiene un canal (20) para recibir un instrumento
quirúrgico.
4. Implante de acuerdo con la Reivindicación 1,
caracterizado porque el canal (20) se desplaza en una
dirección antero-posterior.
5. Implante de acuerdo con una de las
Reivindicaciones 1 a 4, caracterizado porque la estructura
en tres dimensiones comprende una pluralidad de dientes (12).
6. Implante de acuerdo con la Reivindicación 5,
caracterizado porque los dientes (12) tienen una forma
piramidal.
7. Implante de acuerdo con la Reivindicación 6,
caracterizado porque los dientes (12) tienen una forma de
dientes de sierra.
8. Implante de acuerdo con una de las
Reivindicaciones 1 a 7, caracterizado porque al menos una de
las paredes laterales (18, 22, 26, 28) del implante (10, 40, 50,
70, 80) tiene al menos un orificio (24) para la fijación de un
aplicador.
9. Implante de acuerdo con la 8,
caracterizado porque el dicho al menos un orificio (24) esta
fileteado.
10. Implante de acuerdo con las Reivindicaciones
8 a 9, caracterizado porque el dicho al menos un orificio
(24) esta previsto de un lado anterior, posterior,
posterior-lateral o lateral.
11. Implante de acuerdo con una de las
Reivindicaciones 1 a 10, caracterizado porque las
superficies superior e inferior (14, 16) están definidas por unas
superficies planas lisas.
12. Implante de acuerdo con una de las
Reivindicaciones 1 a 11, caracterizado porque una región
entre las superficies superior e inferior (14, 16) y un lado
anterior del implante es un borde curvo (30) para facilitar la
implantación del implante.
13. Implante de acuerdo con una de las
Reivindicaciones 1 a 12, caracterizado porque el mismo es un
implante intervertebral (10, 40, 50, 70, 80).
14. Implante de acuerdo con la Reivindicación 13,
caracterizado porque las superficies superior e inferior (14,
16) son definidas por unas superficies curvas.
15. Implante de acuerdo con una de las
Reivindicaciones 1 a 15, caracterizado porque el implante
(10, 40, 50, 70, 80) tiene un espacio inferior (72) para recibir el
material osteoconductor.
16. Implante de acuerdo con una de las
Reivindicaciones 1 a 15, caracterizado porque el implante
(10, 40, 50, 70, 80) esta dividido en dos partes, una parte superior
(52) teniendo una superficie de conexión superior (56) y una parte
inferior (54) teniendo una superficie de conexión inferior (58)
acoplándose la superficie de conexión superior (56) con la parte de
conexión inferior (58) cuando las partes superior es inferior (52,
54) están unidas.
17. Implante de acuerdo con la Reivindicación 16,
caracterizado porque las superficies de conexión superior e
inferior (56, 58) están provistas con nervios (60) y con ranuras
(62) que se acoplan las unas con las otras con vistas a
interconectar las partes superior e inferior (52, 54).
18. Implante de acuerdo con las Reivindicaciones
16 ó 17, caracterizado porque un pasador (64) es insertado
por un orificio (66) en la parte superior (52) y por un orificio
(66) en la parte inferior (54) para fijar juntas las partes
superior e inferior (52, 54).
19. Implante de acuerdo con la Reivindicación 18,
caracterizado porque el pasador (64) esta hecho de hueso
alógeno.
20. Implante de acuerdo con una de las
Reivindicaciones 1 a 19, caracterizado porque el mismo esta
dividido en una primera y en una segunda parte (70, 70') teniendo
cada una un lado medial (18) con un borde escalonado de forma que
cuando las dos partes (70, 70') son implantadas con sus lados
mediales (18) enfrentados entre sí, los bordes escalonados de
dichos lados mediales (18) de dichas dos partes (70, 70') definen
un espacio cilíndrico (72).
21. Implante de acuerdo con la Reivindicación 20,
caracterizado porque la primera parte (70') esta provista de
un pasador de enclavamiento (74) sobre el lado medial (18) y la
segunda parte (70) esta
provista de una abertura (76) sobre el lado medial (18) configurada y dimensionada para recibir el pasador de enclavamiento (74) para mantener la relación espacial entre dichas dos partes (70, 70').
provista de una abertura (76) sobre el lado medial (18) configurada y dimensionada para recibir el pasador de enclavamiento (74) para mantener la relación espacial entre dichas dos partes (70, 70').
22. Implante de acuerdo con la Reivindicación 21,
caracterizado porque el pasador de enclavamiento (74) es en
hueso alógeno.
23. Implante de acuerdo con una de las
Reivindicaciones 1 a 22, caracterizado porque el implante
(10, 40, 50, 70, 80) tiene una longitud entre 6 - 15 mm.
24. Implante de acuerdo con una de las
Reivindicaciones 1 a 23, caracterizado porque el implante
(10, 40, 50, 70, 80) tiene una longitud entre 15 - 30 mm.
25. Implante de acuerdo con una de las
Reivindicaciones 1 a 24, caracterizado porque el implante
(10, 40, 50, 70, 80) tiene una longitud entre 4 - 30 mm.
26. Implante de acuerdo con una de las
Reivindicaciones 1 a 25, caracterizado porque el implante
(80) esta hecho de una pluralidad de secciones (82, 84, 86) de
interconexión, teniendo cada una de dichas secciones (82, 84, 86)
una superficie acoplándose
con una superficie de la sección de interconexión adyacente.
con una superficie de la sección de interconexión adyacente.
Applications Claiming Priority (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US9520998P | 1998-08-03 | 1998-08-03 | |
| US95209P | 1998-08-03 | ||
| WOPCT/EP99/05008 | 1999-07-15 | ||
| EP9905008 | 1999-07-15 | ||
| PCT/EP1999/005541 WO2000007527A1 (en) | 1998-08-03 | 1999-07-30 | Intervertebral allograft spacer |
| US09/814,214 US7087082B2 (en) | 1998-08-03 | 2001-03-22 | Bone implants with central chambers |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2217796T3 true ES2217796T3 (es) | 2004-11-01 |
Family
ID=26789963
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES99940102T Expired - Lifetime ES2217796T3 (es) | 1998-08-03 | 1999-07-30 | Separador de injerto intervertebral. |
Country Status (9)
| Country | Link |
|---|---|
| US (5) | US6258125B1 (es) |
| EP (1) | EP1100417B1 (es) |
| AT (1) | ATE263526T1 (es) |
| CA (1) | CA2338881C (es) |
| DE (1) | DE69916280T2 (es) |
| DK (1) | DK1100417T3 (es) |
| ES (1) | ES2217796T3 (es) |
| PT (1) | PT1100417E (es) |
| WO (1) | WO2000007527A1 (es) |
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2005
- 2005-06-09 US US11/150,584 patent/US7347873B2/en not_active Expired - Lifetime
- 2005-06-10 US US11/150,608 patent/US7300465B2/en not_active Expired - Lifetime
-
2007
- 2007-10-29 US US11/926,569 patent/US20080046090A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| DE69916280D1 (de) | 2004-05-13 |
| US6258125B1 (en) | 2001-07-10 |
| EP1100417B1 (en) | 2004-04-07 |
| US7300465B2 (en) | 2007-11-27 |
| CA2338881A1 (en) | 2000-02-17 |
| US20050261771A1 (en) | 2005-11-24 |
| DE69916280T2 (de) | 2005-05-25 |
| US20080046090A1 (en) | 2008-02-21 |
| US20020062153A1 (en) | 2002-05-23 |
| US6554863B2 (en) | 2003-04-29 |
| ATE263526T1 (de) | 2004-04-15 |
| EP1100417A1 (en) | 2001-05-23 |
| US20050256574A1 (en) | 2005-11-17 |
| PT1100417E (pt) | 2004-08-31 |
| WO2000007527A1 (en) | 2000-02-17 |
| US7347873B2 (en) | 2008-03-25 |
| HK1036747A1 (en) | 2002-01-18 |
| CA2338881C (en) | 2005-03-15 |
| DK1100417T3 (da) | 2004-08-02 |
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