ES2649114T3 - Nuevo dispositivo de inserción de implantes que tiene una característica de acoplamiento de cola de milano que se extiende lateralmente - Google Patents
Nuevo dispositivo de inserción de implantes que tiene una característica de acoplamiento de cola de milano que se extiende lateralmente Download PDFInfo
- Publication number
- ES2649114T3 ES2649114T3 ES12760847.9T ES12760847T ES2649114T3 ES 2649114 T3 ES2649114 T3 ES 2649114T3 ES 12760847 T ES12760847 T ES 12760847T ES 2649114 T3 ES2649114 T3 ES 2649114T3
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- implant
- instrument
- flexible
- bone
- screw
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- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2002/4635—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using minimally invasive 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
- 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
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2002/4687—Mechanical guides for implantation instruments
Abstract
Un destornillador óseo flexible (100) que comprende: a) un asa proximal (112), b) un eje intermedio (851), c) una porción final distal flexible (853) que comprende una pluralidad de segmentos de enclavamiento (855) y una punta distal (857) adaptada para acoplar una cabeza de tornillo, y d) un manguito pre-doblado (851) que se coloca sobre y alrededor de la pluralidad de segmentos de enclavamiento; caracterizado porque el manguito pre-doblado comprende un corte longitudinal (863).
Description
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Nuevo dispositivo de insercion de implantes que tiene una caracteristica de acoplamiento de cola de milano que se extiende lateralmente
Descripcion
ANTECEDENTES DE LA INVENCION
Los cirujanos de la columna vertebral han expresado un deseo de localizar un implante con un instrumento de perfil vertical bajo para minimizar la retraccion y aumentar la visibilidad del implante. Idealmente, el instrumento y su punto de conexion estan dimensionados para estar contenidos completamente dentro del perfil del implante, siendo as^ mas pequenos que el implante y permitiendo el posicionamiento o colacion faciles del implante. Adicionalmente, la conexion al instrumento debena ser deseablemente ngida, sin alternancia o rotacion en ningun plano. Esta rigidez evita el movimiento del implante durante el paso de instrumentos o la insercion del tornillo oseo.
Los instrumentos de dispositivos de insercion convencionales que poseen caractensticas de chaflan trabajan tipicamente en un plano, en donde una punta de agarre se colapsa sobre el implante en una direccion medial/lateral y asegura de este modo el implante al instrumento. Sin embargo, incluso con tolerancias exigentes, a menudo aparece alternancia si el usuario del instrumento convencional aplicara un momento al borde posterior del implante (en flexion/extension) en un plano. Los dispositivos de insercion convencionales con caractensticas de chaflan tampoco toman ventajas de angulos diferentes en la interfaz en mas de un plano, y por lo tanto falla en asegurar que la superficie anterior del implante baje hasta el fondo en la punta de agarre del dispositivo de insercion.
La Patente US N° 5443514 (Steffee) divulga un dispositivo de insercion que agarra el lateral de un implante espinal, Ver FIGS. 4-6 de Steffee.
La publicacion de Patente US N° 2005-0143749 (Zalenski) divulga un dispositivo de insercion que tiene caractensticas de acoplamiento que forman una forma de cola de milano que se extiende verticalmente. Ver FIGS. 2A-2C de Zalenski.
La Publicacion de Patente Europea N° 1121906 (Degussa) divulga un destornillador para la implantacion intra-oral. El destornillador cuenta con un eje del destornillador que, en uno de sus extremos, esta conectado con una pieza manual y en su otro extremo, a traves de una transmision de engranajes angular, con un portaherramientas giratorio. El eje del destornillador consiste de segmentos del eje que pueden, al menos parcialmente, moverse en relacion unos de los otros y pueden apretarse por medio de un dispositivo de apriete longitudinal comun con el proposito de fijarlos en sus posiciones relativas. Un eje de transmision consiste, en el area de los segmentos del eje, de piezas del eje individuales que, en el area de conexion de los dos segmentos del eje, se conectan a traves de un engranaje angular con el proposito de transmision de torsion.
La Publicacion de Patente Francesa N° 2634260 (Bristol Myers) divulga una transmision de angulo que comprende un miembro de sujecion que tiene un extremo que esta conectado a una herramienta, dicha herramienta accionada por una fuente de energfa externa, y un extremo opuesto que esta conectado a un miembro accionado. Los segmentos de interacoplamiento desmontables estan dispuestos dentro del miembro de sujecion, al casarse con una superficie interna curvada del mismo, y transmitir un movimiento rotacional desde un miembro de transmision externo a una herramienta. Los segmentos comprenden una porcion de forma poligonal y una porcion de cabeza que forma un casquillo poligonal, que puede ser hexagonal.
La Publicacion de Patente US N° 2008/0033440 divulga un aparato de tornillo de fusion osea autoperforante que incluye al menos la primera y segunda cajas deslizantes. Un primer miembro de tornillo que tiene un extremo ahusado y un cuerpo roscado esta dispuesto dentro de la primera caja deslizante, y un segundo miembro de tornillo que tiene un extremo ahusado y un cuerpo roscado dispuesto dentro de la segunda caja deslizante. Un ajustador ajusta la altura de las cajas deslizantes. Los miembros de tornillo se atornillan en los cuerpos vertebrales para fusionar los cuerpos vertebrales juntos.
La Patente US N° 1636636 (Humble) divulga un instrumento quirurgico que comprende un tubo curvado que tiene un extremo biselado y un extremo opuesto que emerge en un barril alargado que tiene un vastago que lleva un asa. El asa esta dispuesta a un angulo al barril. Un taladro esta equipado de manera desmontable en el tubo y el barril y comprende una punta que se proyecta a traves del extremo libre del tubo y esta adaptado para conformar con el tubo. El vastago esta articulado con un eje que ajusta dentro del barril, para el acoplamiento en un portabrocas en un eje de transmision flexible.
La patente US N° 1677337 (Grove) divulga un instrumento quirurgico que comprende un asa hueca dentro de la que esta contenido un mecanismo de transmision friccional para un taladro. Una canula con una porcion doblada esta asegurada a un asa y una rebaba de perforacion montada en una extremidad exterior de la porcion doblada. Un eje giratorio se extiende a traves de una porcion recta de la canula que tiene agarraderas de transmision que interacoplan con agarraderas de una primera seccion corta de una serie de secciones acopladas a
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la rebaba de perforacion.
SUMARIO DE LA INVENCION
La presente invencion proporciona un destornillador oseo flexible como se reivindica en la reivindicacion 1.
La presente invencion tambien proporciona un montaje como se reivindica en la reivindicacion 4, que comprende una jaula de fusion, un tornillo oseo y el destornillador oseo flexible de la reivindicacion 1.
Caractensticas adicionales opcionales del destornillador oseo flexible y del montaje se definen en las reivindicaciones dependientes.
Se divulga en la presente un implante intervertebral. El implante intervertebral tiene un nuevo receso de "angulo compuesto", como una forma de cola de milano, disenada y dimensionada para acoplarse con un instrumento de administracion. La interfaz entre el implante y el instrumento de sujecion esta disenada con caractensticas de chaflan anguladas, que se extienden lateralmente que se extienden en mas de una direccion para evitar la alternancia y la rotacion. Una vez que el instrumento de punta dividida se colapsa a su posicion cerrada, el implante se va metiendo en el dispositivo de insercion y se permite que baje hasta el fondo en una pared distal del dispositivo de insercion.
El instrumento divulgado en la presente es ventajoso sobre los instrumentos de dispositivos de insercion convencionales que tienen roscas y otras caractensticas de agarre, que algunas veces necesitan resistir impacto y pueden moverse tras la insercion de un anclaje oseo o instrumentos a traves del dispositivo.
La naturaleza de angulo dual asegura que el implante es axialmente cuadrado y/o co-lineal con el instrumento y asf asegura ademas que un area superficial mas grande del instrumento absorba cualquier impacto requerido.
El implante puede tener tambien un angulo anadido, en el que la dimension en la porcion anterior de la caractenstica esta dimensionada para ser mas pequena que la porcion posterior de la caractenstica. Ver FIG. 6.
En ejemplos particulares, el instrumento tiene un eje interior ahorquillado con horquillas distales que se extienden desde el mismo, en donde cada horquilla distal forma una caractenstica de cola de milano que se extiende medialmente. Esta caractenstica de cola de milano posee la angulacion compuesta que evita los movimientos no deseados tratados anteriormente.
En ejemplos preferidos, la pared proximal del implante tiene un par correspondiente de recesos que se abren sobre sus paredes laterales respectivas. Cada uno de estos recesos forma una silueta de cola de milano en su pared lateral respectiva del implante.
Se divulga un metodo y aparato para ayudar en una insercion con una mano segura de un implante. El dispositivo de implantacion de implantes incluye generalmente (i) un marco que incluye un mecanismo de activacion, (ii) un manguito exterior acoplado mecanicamente al marco, (iii) un eje interior ahorquillado que tiene horquillas distales para acoplar mecanicamente un implante, el eje interior ahorquillado dispuesto deslizablemente dentro del manguito exterior y (iv) un elemento de retencion para dirigir las horquillas distales hacia una posicion cerrada. El elemento de retencion puede ser un resorte.
Elementos opcionales del dispositivo de insercion pueden incluir una empunadura, un tornillo de ajuste del arrastre, al menos una protrusion, y un miembro de control de la profundidad. La empunadura puede estar acoplada mecanicamente al manguito exterior para provocar que el manguito exterior y el eje interior ahorquillado se roten sobre el marco. El tornillo de ajuste del arrastre puede proporcionar tension entre el mecanismo de activacion y el eje interior ahorquillado. La al menos una protrusion puede estar localizada en el manguito exterior para acoplar deslizablemente un instrumento de distension. El miembro de control de la profundidad puede acoplarse deslizablemente al manguito exterior para proporcionar una profundidad de insercion predeterminada del implante.
Las horquillas distales del dispositivo de insercion sostienen el implante entre ellas durante la insercion del implante entre las vertebras. Cada horquilla distal incluye una caractenstica de acoplamiento en su punta para acoplar mecanicamente el implante. La caractenstica de acoplamiento comprende una protrusion con forma de cola de milano que se extiende en la direccion lateral. Generalmente, la caractenstica de acoplamiento tiene una cara medial, con cada cara medial teniendo una porcion de extremo proximal que tiene una altura y una porcion de extremo distal que tiene una altura, en donde la altura de la porcion del extremo distal es mayor que la porcion del extremo proximal. Al mismo tiempo, la pared frontal del implante comprende un par de recesos de cola de milano que se extienden lateralmente que coinciden que se abren sobre una pared lateral respectiva y forman una silueta de cola de milano en cada pared lateral, en donde cada caractenstica de acoplamiento del instrumento se recibe en un receso respectivo del implante espinal.
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El eje interior ahorquillado puede incluir al menos una marca para identificar una posicion del implante en relacion con el paciente. La marca puede ser una clavija localizada en una superficie del eje interior ahorquillado. La marca puede ser una pluralidad de ranuras mecanizadas en una superficie del eje interior ahorquillado.
Acoplar mecanicamente el instrumento de implantacion al implante puede incluir los pasos de (i) abrir el eje interior ahorquillado localizado en un extremo del instrumento de implantacion, (ii) alinear las horquillas del eje interior ahorquillado con los recesos del implante, y (iii) cerrar las horquillas para acoplar mecanicamente las horquillas con el implante. El metodo puede incluir ademas los pasos de (iv) distender un espacio de disco preparado con un instrumento de distension, (v) insertar el implante en el espacio de disco preparado con el instrumento de implantacion, (vi) liberar el implante del instrumento de implantacion, y (vii) retirar el instrumento de implantacion y el instrumento de distension.
En algunos metodos ejemplares, insertar el implante en un espacio de disco preparado puede incluir el paso de alinear el instrumento de implantacion con el instrumento de distension.
Las ventajas incluyen la insercion con una mano segura de un implante en un espacio de disco preparado. La reduccion de la cantidad de tiempo requerido para completar el procedimiento quirurgico. La capacidad de proporcionar varias manipulaciones del implante sin contactar ffsicamente con el implante. Por ejemplo, la invencion puede alinear una placa terminal del implante radialmente y proporcionar un angulo lordotico para la implantacion. El empaquetado del implante, y el uso para sostener el implante durante el proceso de esterilizacion del implante.
Se divulga un instrumento para insertar un implante, que comprende:
a) un manguito exterior que tiene un orificio, y
b) un miembro ahorquillado que tiene una barra proximal y un par de horquillas distales que se extienden desde la misma, cada horquilla distal comprendiendo una porcion proximal y una porcion distal que tiene una pared distal que tiene un miembro de acoplamiento que se extiende distalmente desde la misma, cada miembro de acoplamiento teniendo una cara medial que forma una forma de cola de milano,
en el que la barra proximal y la porcion proximal de cada horquilla se reciben deslizablemente dentro del orificio del manguito exterior, y
en el que la porcion distal de cada horquilla se extiende fuera del orificio del manguito exterior.
Tambien se divulga un montaje que comprende:
a) el dispositivo de insercion anteriormente descrito, y
b) un implante espinal que tiene una pared frontal, un par de paredes laterales opuestas y una pared posterior,
en el que la pared frontal comprende un par de recesos que se abren sobre una pared lateral respectiva para formar una forma de cola de milano en cada pared lateral respectiva,
en el que cada caractenstica de acoplamiento del instrumento se recibe en un receso respectivo del implante espinal.
Tambien se divulga un implante ortopedico que tiene una pared frontal, un par de paredes laterales opuestas, una pared posterior, y superficies superior e inferior, en donde la pared frontal comprende un par de recesos, cada receso abriendose sobre una pared lateral respectiva y formando una forma de cola de milano en la pared lateral respectiva.
DESCRIPCION DE LOS DIBUJOS
La FIG. 1A muestra una vista en seccion transversal de un instrumento de insercion, y partes de un destornillador oseo flexible de acuerdo con una realizacion de la presente invencion.
La FIG. 1B muestra una vista en planta del instrumento de insercion/destornillador oseo flexible de la FIG. 1A. Las FIGS. 2A-2C muestran una vista en perspectiva de tres realizaciones de un eje interior ahorquillado del instrumento de insercion.
La FIG. 3 muestra una vista en perspectiva de un implante siendo insertado en un espacio de disco preparado usando el instrumento de insercion de las FIGS. 1A-2C.
La FIG. 4 muestra dos vistas de un instrumento que tiene caractensticas de agarre de cola de milano aproximandose a un implante que tiene caractensticas de recesos de cola de milano correspondientes.
La FIG. 5 divulga una jaula de fusion intervertebral de la presente invencion.
La FIG. 6 divulga una esquina de un implante que tiene una pared lateral que tiene un receso en la misma, en la que el receso comprende dos angulos agudos a y p.
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La FIG. 7 divulga una vista en perspectiva de una punta del dispositivo de insercion del instrumento de insercion.
La FIG. 8 divulga una vista en perspectiva de un punta del dispositivo de insercion iluminada del instrumento de insercion.
Las FIGS. 8A-8F divulgan partes de un destornillador oseo flexible de acuerdo con una realizacion de la presente invencion, que comprende un manguito pre-doblado.
DESCRIPCION DETALLADA DE LA INVENCION
Lo anterior y otros objetos, caractensticas y ventajas de la invencion seran aparentes de la siguiente descripcion mas particular de las realizaciones preferidas de la invencion, como se ilustra en los dibujos acompanantes en los que caracteres de referencia similares se refieren a las mismas partes a lo largo de las diferentes vistas. El mismo numero que aparece en dibujos diferentes representa el mismo elemento. Los dibujos no estan necesariamente a escala, poniendose el enfasis en su lugar en ilustrar los principios de la invencion.
En general, la presente invencion se refiere a un aparato para insertar con seguridad un implante en una columna vertebral. Se divulga un metodo correspondiente, que no esta dentro del alcance de la invencion reivindicada. El implante puede ser un disco artificial o jaula de fusion espinal, o una placa espinal. En referencia a las FIGS. 1A y 1B, se muestra un instrumento de insercion 100 en una vista transversal y una vista en planta, respectivamente. Los dibujos tambien ilustran partes de un destornillador oseo flexible de acuerdo con una realizacion de la presente invencion, que se tratara con mas detalle a continuacion. El instrumento de insercion 100 incluye un marco o montaje del cuerpo del impulsor 110, un montaje del accionador 126 y un eje interior ahorquillado 160 (FIG. 2A-2C). El instrumento de insercion 100 es un dispositivo normalmente cerrado, es decir la barra proximal del eje interior ahorquillado 160 esta normalmente sustancialmente contenida dentro del montaje del accionador 126. El montaje del accionador 126 incluye un manguito exterior 130, un eje interior proximal 140, y una clavija de retencion 148. El manguito exterior 130 incluye un extremo ahusado 175 que acopla deslizablemente con las uniones ahusadas 163 del eje interior ahorquillado 160 (FIG. 2A-2C), permitiendo la compresion y expansion del eje interior ahorquillado 160 cuando esta en uso. El eje interior 140 incluye un extremo roscado hembra 142 y un extremo roscado macho 144. El extremo roscado hembra 142 coincide con una un tornillo de retencion de resorte 152 y el extremo roscado macho 144 coincide con el eje interior ahorquillado 160. El resorte de compresion interior 150 esta sujeto al montaje del accionador 126 y se mantiene en su sitio por el tornillo de retencion de resorte 152. Una vez que el montaje del accionador 126 esta montado, se inserta en el montaje del cuerpo del impulsor 110 y se retiene dentro del montaje 110 con la clavija de retencion 148. La empunadura opcional 170 puede unirse mecanicamente al manguito exterior 130 para permitir que el manguito exterior 130 y el eje interior proximal 140 roten sobre el montaje del cuerpo del impulsor 110. Las grnas opcionales 171 pueden unirse al manguito exterior 130 para coincidir deslizablemente con el instrumento de distension del disco espinal 950 (FIG. 3). El miembro de control de profundidad 173 tambien puede estar unida fija o deslizablemente en el manguito exterior 130 para proporcionar una profundidad de insercion predeterminada del implante.
El montaje del cuerpo del impulsor 110 incluye el asa 112, la transicion del asa 114, la cabeza de golpeo 116, el mecanismo de activacion 120, y la clavija de pivote 122. El mecanismo de activacion 120 puede ser cualquier tipo de mecanismo de activacion conocido en la tecnica. El mecanismo de activacion 120 pivota sobre la clavija de pivote 122 en el montaje del cuerpo del impulsor 110. Cuando el mecanismo de activacion 120 se aprieta hacia el asa 112, el eje interior ahorquillado 160 (FIG. 2A-2C) se extiende desde el montaje del accionador 126 y se expande para liberar un implante. Cuando se libera el mecanismo de activacion 120, el eje interior ahorquillado 160 retrocede al montaje del accionador 126 y comprime, acoplando de este modo el implante o retornando a su posicion normalmente cerrada. El tornillo de ajuste de arrastre opcional 124 esta acoplado rotativamente al montaje del cuerpo del impulsor 110 para ajustar la fuerza de arrastre entre el mecanismo de activacion 120 y el tornillo de retencion del resorte 152 del montaje del accionador 126.
Las FIGS. 2A-2C muestran varios ejes interiores ahorquillados 160 del instrumento. Cada eje interior ahorquillado 160 incluye las caractensticas de acoplamiento 162 para acoplar mecanicamente el implante. Las caractensticas de acoplamiento 162 pueden ser de varias formas y tamanos dependiendo de la seleccion del implante. Como se muestra, las caractensticas de acoplamiento 162 pueden ser de forma de cola de milano (162a, 162b, 162c, 162d). Las caractensticas de acoplamiento 162 pueden acoplar implantes que tienen diferentes alturas. Debe entenderse que las caractensticas de acoplamiento 162 pueden ser de cualquier forma que acople con cualquier tipo de implante. En un ejemplo alternativo, el eje interior proximal 140 y el eje interior ahorquillado 160 pueden ser integrales.
Cada eje interior ahorquillado 160 incluye el orificio roscado hembra 161 para coincidir con el extremo roscado macho 144 del eje interior proximal 140 del montaje del accionador 126. Debe entenderse que puede usarse cualquier medio conocido en la tecnica para unir el eje interior ahorquillado 160 con el eje interior proximal 140.
Cada eje interior ahorquillado 160 incluye las uniones ahusadas 163 y la ranura de expansion/compresion
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relativamente larga 164 para permitir que el eje interior ahorquillado 160 se expanda y comprima durante el uso. Las FIGS. 2A-2C muestran el eje interior ahorquillado 160 en la posicion expandida. Cada eje interior ahorquillado 160 tambien incluye la ranura de dimensionamiento 166 para permitir una variacion en las diferencias dimensionales de la lengueta y la ranura del eje interior ahorquillado. La ranura de expansion/compresion 169 (FIG. 2B ) es un ejemplo alternativo de la ranura de dimensionamiento 166. En algunos ejemplo, el miembro ahorquillado tiene una caractenstica de conexion rapida.
Pueden incluirse marcadores orientados hacia la cabeza 168 en una superficie del eje interior ahorquillado 160 para permitir al usuario determinar la posicion del implante. Los marcadores 168 pueden ser una clavija 168a o ranuras mecanizadas 168b. En algunas realizaciones, el dispositivo de insercion (asa de apriete) tiene una caractenstica de conexion rapida.
En un metodo de uso, y ahora en referencia a las FIGS. 4a y 4b, el usuario aprieta primero el mecanismo de activacion 120 (FIG. 1) en el instrumento de implantacion 100, provocando de este modo que las caractensticas de acoplamiento 162c, 162d en el instrumento se separes. El usuario acerca luego el implante objetivo (en este caso, una placa cervical 201) con el instrumento de implantacion de tal manera que las caractensticas de cola de milano de estos dos dispositivos se alineen por lo que las caractensticas de acoplamiento 162 se montan sobre las muescas de acoplamiento opuestas 906 en el implante. Una vez que las caractensticas de acoplamiento 162 se montan sobre las muescas de acoplamiento 906, el usuario libera el mecanismo de activacion 120, provocando que las caractensticas de acoplamiento 162 colapsen hacia adentro y acoplen las muescas de acoplamiento 906 en el implante.
En otros ejemplos, se proporciona lo contrario, en donde el usuario aprieta el instrumento para acoplar el
implante.
En referencia ahora a la FIG. 5, se proporciona una jaula de fusion intervertebral 301 de la presente invencion. La jaula comprende una pared frontal 303, una pared posterior 304, un par de paredes laterales opuestas 350 que conectan las paredes frontal y posterior, una superficie superior 306 adaptada para acoplar con una vertebra superior, una superficie inferior (no mostrada) adaptada para acoplar con una vertebra inferior, y un agujero pasante 307 que se extiende entre las superficies superior e inferior para promover la fusion a traves de ellas, en donde la pared frontal comprende un par de recesos 311, cada receso abriendose sobre una pared lateral respectiva y formando una forma de cola de milano en la pared lateral respectiva. La pared frontal en esta jaula particular tambien tiene agujeros de tornillo 313 que se extienden a traves de ella. Los agujeros de tornillo estan tfpicamente roscados y estan adaptados para recibir tornillos oseos para asegurar la jaula a los cuerpos vertebrales opuestos sin la necesidad de instrumentacion posterior, proporcionando de este modo capacidades "independientes".
Ahora en referencia a la FIG. 6, tambien de acuerdo con la presente invencion, se proporciona un implante espinal que tiene una pared frontal, una par de paredes laterales opuestas, una pared posterior, y superficies superior e inferior, en donde la pared frontal comprende un par de recesos, cada receso abriendose sobre una pared lateral respectiva y formando al menos dos angulos agudos a y p en la pared lateral respectiva. La naturaleza aguda de estos dos angulos en el mismo receso crea la condicion necesaria para impedir la alternancia y la rotacion.
En algunas realizaciones, las superficies superior e inferior del implante estan espaciadas a una distancia adecuada para contactar con placas terminales vertebrales opuestas. Esta caractenstica es ventajosa para implantes espinales insertados en un espacio discal.
En algunas realizaciones, el implante de la presente invencion tiene un agujero pasante que se extiende desde su superficie superior a su superficie inferior. Esta caractenstica de agujero pasante promueve la fusion osea a traves del implante y proporciona asf una ventaja de rendimiento para realizaciones de jaula de fusion de la presente invencion.
En algunas realizaciones del mismo, se contiene un material de injerto oseo en el agujero pasante de la jaula de fusion. Este material de injerto tambien promueve la fusion a traves del implante y proporciona asf una ventaja de rendimiento para realizaciones de jaula de fusion de la presente invencion.
En algunas realizaciones del implante, la jaula de fusion tiene una pared frontal que esta fabricada de manera separada del resto del implante. Preferiblemente, la pared frontal es metalica y el resto del implante es polimerico. Esta realizacion preferida proporciona ventajosamente resistencia en la pared frontal de tal manera que los agujeros de tornillo pueden pasar a traves de ella sin fracturar la pared.
En algunas realizaciones, la primera y segunda sujeciones oseas se extienden a traves de los agujeros de tornillo localizados en la pared frontal de la jaula de fusion. Esta caractenstica permite que la jaula se asegure a las vertebras opuestas y elimina asf la necesidad de instrumentacion posterior. En algunas realizaciones del mismo, la primera sujecion se extiende adicionalmente a traves de la superficie superior del implante, mientras que la segunda sujecion se extiende adicionalmente a traves de la superficie inferior del implante.
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En algunas realizaciones, la primera y segunda sujeciones oseas se extienden solo a traves de la pared frontal, como en una realizacion de placa.
En algunas realizaciones, el implante tiene una interfaz de articulacion, como en un disco de movimiento articulado.
La FIG. 3 divulga un instrumento que inserta un implante en un espacio discal.
Como se muestra en la FIG. 3, el instrumento de distension 950 se inserta sobre las clavijas (no mostradas) que estan aseguradas en los cuerpos vertebrales 962, 964. La jaula de fusion cervical 330 se pasa entre las horquillas del instrumento de distension 950 usando el instrumento de implantacion 100 (FIGS. 1A-1B). En una realizacion alternativa, las grnas 170 en el instrumento de insercion 100 acoplan deslizablemente las ranuras en las horquillas del instrumento de distension 950 para ayudar al usuario a guiar la jaula de fusion cervical 330 en el espacio discal preparado 970. Una vez que la jaula de fusion cervical 330 esta en una localizacion deseada dentro del espacio discal preparado 970, el usuario acciona (por ejemplo, aprieta, o libera o rota una empunadura) el mecanismo de accionamiento 120 (FIG. 1A), que libera la jaula de fusion cervical 330 en el espacio discal preparado 970. El usuario puede determinar la posicion deseada observando los marcadores orientados hacia la cabeza 168 (FIGS. 3A-3B) localizados en una superficie del eje interior ahorquillado 160. En una alternativa, el instrumento de implantacion 100 puede incluir un miembro de control de la profundidad 173 (FIG. 1A) (que podna ser ajustable y deslizable), de tal manera que la jaula de fusion cervical 330 pueda insertarse en un espacio discal preparado 970 a una profundidad predeterminada.
Por ultimo, el instrumento de implantacion 100 y el instrumento de distension 950 se retira, provocando que la vertebra superior 962 y la vertebra inferior 964 acoplen con la jaula de fusion cervical 330.
Ahora en referencia a la FIG. 7, se muestra un ejemplo de la punta del dispositivo de insercion 701. La punta del dispositivo de insercion incluye un tope del barril 703 que evita que el tornillo oseo se desprenda. Hay una caractenstica de conexion/liberacion rapida distal 705 que permite una conexion facil del resto del instrumento del dispositivo de insercion. Los barriles 707 evitan que el implante se coloque demasiado alejado posteriormente. Las caractensticas de relieve 709 en la cola de milano permiten que la caractenstica de acoplamiento se desacople con facilidad del implante. Por ultimo, los barriles 711 pueden ser un barril fijo o ajustable deslizando el miembro como una caractenstica de trinquete.
Ahora en referencia a la FIG. 8, se muestra un ejemplo de una punta del dispositivo de insercion iluminada 801. La canula del dispositivo de insercion esta equipada con al menos un lumen secundario 803 adaptado para administrar luz o administrar una fibra optica. La luz que emana del lumen secundario se muestra en las lmeas discontinuas en la FIG. 8. Alternativamente, la luz puede ser alimentada por el lumen principal que sostiene la punta del elemento de insercion (no mostrado). En un ejemplo, al menos las caractensticas de acoplamiento 850 de la punta estan hechas de plastico claro duro que permite la visibilidad de los otros instrumentos pasados a traves de los barriles.
Cuando se realiza un procedimiento espinal como una discectomfa y fusion cervical anterior (ACDF). el cirujano tiene a menudo una variedad de opciones de implante que pueden lograr los resultados clmicos deseados de mantenimiento de altura del disco y alivio del dolor. Debido a sus beneficios clmicos, las jaulas de fusion de perfil cero que aceptan anclajes oseos y se aseguran a la anatoirna adyacente han experimentado un uso y adopcion crecientes en el procedimiento de ACDF. Estas jaulas tienen tfpicamente anclajes oseos angulados (como tornillos) que pasan a traves de una porcion de la pared anterior de la caja y en las placas terminales vertebrales adyacentes.
Sin embargo, si un cirujano fuera a elegir un dispositivo de fusion independiente, de perfil bajo (como una jaula de fijacion que comprende uno o mas tornillos oseos), sigue habiendo un desafm de la tecnica quirurgica asociado con la insercion de los tornillos. Tradicionalmente, se usa un instrumento que tiene un eje recto para insertar los tornillos a traves de la jaula en el angulo inclinado para asegurar la penetracion osea. Sin embargo, la insercion del tornillo con un instrumento de eje recto en localizaciones cerca de la barbilla o el esternon del paciente produce algunos angulos de aproximacion desafiantes. Recientemente, han habido mejoras en el instrumento de insercion que ayudan a facilitar la colocacion de tornillos en estos angulos de aproximacion diffciles. Algunas de estas mejoras incluyen la adopcion de articulaciones universales e instrumentos de dispositivo de insercion flexibles que permiten la transmision de torsion a la vez que todavfa se posicionan sus asas fuera del eje de la trayectoria del tornillo. Por ejemplo, algunos instrumentos de dispositivo de insercion flexibles logran flexibilidad poseyendo una pluralidad de segmentos de enclavamiento justo proximales a sus puntas de trabajo distales. Una vez que la punta de tal impulsor flexible se inserta en la grna del taladro, el asa del impulsor puede reposicionarse en la localizacion deseada y la torsion puede transmitirse para hacer avanzar el tornillo.
Sin embargo, uno de los desaffos asociados con esta tecnologfa flexible es que el eje flexible es tfpicamente recto en su configuracion de reposo. Por consiguiente, necesita llevarse a cabo uno de dos
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procedimientos. En un primer procedimiento, la cantidad de retraccion de tejido blando tiene que aumentarse temporalmente para acoplar la punta del impulsor en la gma del taladro y una vez acoplada, puede minimizarse la retraccion del tejido blando de nuevo y se puede mantener el asa en una posicion deseable, como cerca paralela al dispositivo de insercion del implante. En un segundo procedimiento, la punta puede insertarse en la gma del taladro a un angulo de inclinacion menor que la trayectoria del tornillo (pero no perfectamente paralelo al dispositivo de insercion) y tiene que superarse la fuerza de resorte del segmento flexible para que la punta encuentre la trayectoria de la gma del taladro. En este paso de "doblar la esquina", a medida que se aplica una fuerza descendente, puede desacoplarse la auto-retencion del tornillo.
Por lo tanto, para superar estos problemas, en un aspecto de la presente invencion, y ahora en referencia a las FIGS. 8A-8F, se proporciona una mejora de la tecnologfa de eje flexible que tiene beneficios para el paciente y el cirujano. La mejora es un destornillador oseo que tiene a) un asa proximal (no mostrada), b) un eje intermedio 851,
c) una porcion final distal flexible 853 que comprende una pluralidad de segmentos de enclavamiento 855 y una punta distal 857 (en donde la porcion final distal flexible es sustancialmente recta en su configuracion descargada), y
d) un manguito pre-doblado 861 que se coloca sobre y alrededor de los segmentos flexibles, predeterminando de este modo la trayectoria de la punta y facilitando el angulo de insercion apropiado y deseado del tornillo en la gma del taladro sin aumentar la cantidad de retraccion. Como se muestra en las FIGS. 8a-8f, este manguito pre-doblado (que tiene un corte longitudinal 863) permite que un asa del destornillador este perfectamente alineado con el dispositivo de insercion de la jaula si se desea, a la vez que se sigue aprovechando la sensacion tactil y transmision de torsion del segmento flexible en su posicion doblada. Por consiguiente, un cirujano puede limitar la cantidad de retraccion y mantener el asa del impulsor cercana al dispositivo de insercion sin tener que superar las fuerzas de la configuracion recta natural del segmento flexible. El manguito puede ser fijo, deslizable o desmontable y puede abarcar completa o parcialmente los segmentos flexibles. El manguito puede tener geometnas que permiten la flexion, union (fijacion a presion) al impulsor, y la retirada para limpieza, si se desea. El manguito puede estar hecho de cualquier material biocompatible que mantenga la forma deseada (como metal o plastico).
Un destornillador oseo flexible ejemplar comprende:
a) un asa proximal,
b) un eje intermedio,
c) una porcion final distal flexible que comprende una pluralidad de segmentos de enclavamiento y una punta distal adaptada para acoplar una cabeza de tornillo, y
d) un manguito pre-doblado colocado sobre y alrededor de la pluralidad de segmentos de enclavamiento.
Tambien un montaje ejemplar comprende:
a) una jaula de fusion que comprende una pared frontal, un par de paredes laterales opuestas, una pared posterior, y superficies superior e inferior adaptadas para agarrar placas terminales vertebrales opuestas, en donde la pared frontal comprende al menos un agujero pasante roscado,
c) un tornillo oseo recibido en el agujero pasante roscado, el tornillo oseo teniendo un eje roscado y una cabeza proximal,
c) el destornillador oseo de las FIGS 8A-8F,
en donde la punta distal del dispositivo de insercion se recibe en la cabeza proximal del tornillo oseo.
Aunque esta invencion se ha mostrado y descrito particularmente con referencias a las realizaciones preferidas de la misma, se entendera por los expertos en la tecnica que pueden hacerse varias cambios en la forma y los detalles.
Claims (4)
- 5101520253035404550556065Reivindicaciones1. Un destornillador oseo flexible (100) que comprende:a) un asa proximal (112),b) un eje intermedio (851),c) una porcion final distal flexible (853) que comprende una pluralidad de segmentos de enclavamiento (855) y una punta distal (857) adaptada para acoplar una cabeza de tornillo, yd) un manguito pre-doblado (851) que se coloca sobre y alrededor de la pluralidad de segmentos de enclavamiento;caracterizado porque el manguito pre-doblado comprende un corte longitudinal (863).
- 2. El impulsor de la reivindicacion 1 en donde la porcion final distal flexible es sustancialmente recta en su configuracion descargada.
- 3. Un montaje que comprende:a) una jaula de fusion (301) que comprende una pared frontal (303), un par de paredes laterales opuestas (305), una pared posterior (304), y superficies superior (306) e inferior adaptadas para agarrar placas terminales vertebrales opuestas, en donde la pared frontal comprende al menos un agujero pasante roscado (313),b) un tornillo oseo recibido en el agujero pasante roscado, el tornillo oseo teniendo un eje roscado y una cabeza proximal,c) el destornillador oseo flexible (100) de la reivindicacion 1,en donde la punta distal (857) del destornillador oseo flexible se recibe en la cabeza proximal del tornillo oseo.
- 4. El montaje de la reivindicacion 3, en donde la porcion final distal flexible (853) del impulsor es sustancialmente recta en su configuracion descargada.
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-
2011
- 2011-09-20 US US13/237,200 patent/US20120078372A1/en not_active Abandoned
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2012
- 2012-02-01 US US13/364,280 patent/US10369015B2/en active Active
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- 2012-03-20 WO PCT/US2012/029761 patent/WO2012129206A2/en active Application Filing
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US10369015B2 (en) | 2019-08-06 |
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JP6195954B2 (ja) | 2017-09-13 |
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EP2688520B1 (en) | 2017-09-27 |
US20120078372A1 (en) | 2012-03-29 |
AU2012231117B2 (en) | 2016-03-03 |
CN104185452A (zh) | 2014-12-03 |
WO2012129206A2 (en) | 2012-09-27 |
CN104185452B (zh) | 2017-06-13 |
WO2012129206A3 (en) | 2012-11-22 |
EP2688520A4 (en) | 2015-04-29 |
JP2016172005A (ja) | 2016-09-29 |
AU2012231117A1 (en) | 2013-10-17 |
US11382768B2 (en) | 2022-07-12 |
EP2688520A2 (en) | 2014-01-29 |
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