ES2362475T3 - Aparato de acceso a la médula ósea. - Google Patents
Aparato de acceso a la médula ósea. Download PDFInfo
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- ES2362475T3 ES2362475T3 ES09155111T ES09155111T ES2362475T3 ES 2362475 T3 ES2362475 T3 ES 2362475T3 ES 09155111 T ES09155111 T ES 09155111T ES 09155111 T ES09155111 T ES 09155111T ES 2362475 T3 ES2362475 T3 ES 2362475T3
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Abstract
Un aparato para la extracción de porciones de hueso y médula ósea a partir de un hueso para los fines de diagnóstico y de tipo terapéutico, que comprende: un armazón (12); un eje (14) motor hueco dispuesto en el armazón (12) y operativo para acoplar un conjunto de engranajes (37); el conjunto de engranajes (37) es operativo para girar el eje (14) motor hueco; un penetrador (20) operable para penetrar la médula ósea y recogiendo las muestras de la médula ósea; un motor (38) acoplado al eje motor hueco y operable para accionar el penetrador (20) mencionado dentro de la médula ósea por la rotación del eje motor hueco; una fuente de alimentación (39) y un circuito asociado operable para alimentar el motor (38); un trocar interior (19) que se extiende por un canal interno (15) del eje motriz (14) y un conducto a través del penetrador (20) por lo que un primer extremo del mencionado trocar es operable para penetrar la médula ósea y teniendo un segundo extremo, en donde el trocar (19) interno es desmontable del canal interno (15) y el conducto y un conector (36) que son operables para fijar en forma desmontable el mencionado penetrador (20) al extremo distal del eje motor hueco; en donde el motor y el eje motor hueco (14) están caracterizados porque el eje motor hueco (14) comprenden un canal interno (15) operable para desplazar las porciones de la médula ósea a un operador, y un extremo proximal operable para permitir la recuperación de las porciones de la médula ósea.
Description
CAMPO TÉCNICO
La presente invención está relacionada con un aparato para la extracción de muestras del hueso o de la médula ósea. El aparato puede utilizarse para extraer células madre o médula ósea para un transplante o para fines de diagnóstico.
ANTECEDENTES
Existen muchas situaciones clínicas en donde es importante el poder tener acceso y poder recuperar médula ósea. En algunos casos puede ser necesario el tratamiento de enfermedades con la médula ósea o el transplante de células Madrid para restaurar el funcionamiento de las células de la sangre en el cuerpo después de una quimioterapia de alta dosis. Tales situaciones pueden incluir leucemias aguas, tumores cerebrales, cáncer de mama, enfermedad de Hodgkin, mieloma múltiple, neuroblastoma, linfomas de tipo no Hodgkin, cáncer de ovario, sarcoma y cáncer testicular. En otros casos, es necesario tener acceso a la médula ósea para obtener una muestra de la médula para las pruebas de diagnóstico. Estas situaciones pueden incluir un cáncer de cualquier tipo y una enfermedad de cualquier origen.
Las técnicas actuales para tener acceso a la medula ósea pueden ser difíciles, traumáticas y peligrosas, dependiendo del punto seleccionado para la recogida de muestras, de la experiencia del operador y de la anatomía del paciente. En general, los dispositivos disponibles para tener acceso a la cavidad medular del hueso, en donde está localizada la médula ósea, incluyen una aguja de tipo Trocar, con unas asas para facilitar la aplicación de presión y de rotación. Estos tipos de dispositivos requieren el tener que forzar substancialmente la rotura a través de un cortex exterior del hueso mediante una técnica de fractura. La aplicación de una alta presión sobre la aguja provoca un dolor en el paciente y otros daños de la punta de la aguja. Esto es particularmente un problema cuando se realiza la recogida desde el esternón de un paciente porque la fuerza en exceso puede provocar la penetración a través del esternon, y puede provocar daños en las estructuras subyacentes tales como el corazón y los grandes vasos.
Otro inconveniente de las técnicas actuales para tener acceso a la médula ósea es que frecuentemente se requiere más de un punto de penetración en el hueso para poder recuperar la medula ósea suficiente para poder realizar las pruebas de diagnostico o para los fines del transplante. Para poder recuperar una muestra adecuada de medula ósea para una medula ósea o un transplante de células madre, el médico puede necesitar situar la aguja en varias partes diferentes de la pelvis, lo cual puede requerir hasta seis puntos de pinchazos o más. Este requisito puede ser extremadamente doloroso para el paciente, y puede desalentar a las personas donantes de poder donar la medula ósea. Esta técnica de utilizar pasos múltiples puede también provocar fatiga en operadores más pequeños, que podrían adolecer de la falta de resistencia para poder completar los procedimientos de pasos múltiples.
La recuperación de las muestras de huesos para los fines de diagnóstico es igualmente difícil. Ocasionalmente la muestra del núcleo del hueso no se recupera porque no se extrae con éxito con una aguja de biopsia estándar. Así pues, pueden ser necesarios múltiples intentos para poder obtener satisfactoriamente una biopsia de hueso o de médula ósea.
Las técnicas actuales requieren que las agujas de biopsia tengan que ser forzadas por la presión manual dentro del hueso. Estas técnicas pueden tener efectos colaterales no deseados tales como el deterioro de la punta de la aguja
o bien el deslizamiento de la aguja fuera del objetivo del hueso propuesto dentro de los órganos o de los tejidos blandos.
El lector puede obtener una explicación en cuanto el estado de la técnica por referencia a la técnica más actual a través del documento FR 853349.
SUMARIO DE LA INVENCIÓN
Existe una necesidad de un aparato para tener acceso a la médula ósea que sea traumática en forma mínima para el paciente, y que permita la extracción de una cantidad suficiente en la primera vez que se penetre en el hueso. Es un objeto de la invención el proporcionar un aparato para la extracción de porciones de la medula ósea a partir de un hueso.
De acuerdo con la invención, este objeto puede conseguirse por el aparato de acuerdo con la reivindicación 1. Las realizaciones preferidas están denegadas por las reivindicaciones dependientes.
5
10
15
20
25
30
35
40
BREVE DESCRIPCIÓN DE LOS DIBUJOS Puede conseguirse una comprensión más completa de un aparato para extraer porciones de hueso y de médula ósea a partir de un hueso y sus ventajas, a modo de ejemplo, por referencia a la siguiente descripción tomada en
conjunción con los dibujos adjuntos, en donde los números de referencia iguales indican características similares, y en donde: La figura 1A ilustra un aparato que no cae bajo el alcance de la invención para la extracción de una muestra de
médula ósea que se muestra en una sección longitudinal transversal.
La figura 1B ilustra un eje motriz hueco.
La figura 1C ilustra una realización de un trocar.
La figura 1D ilustra una realización de un aparato.
La figura 1E ilustra una realización de un aparato de acuerdo con la invención para extraer un muestra de médula
ósea en una sección transversal longitudinal.
La figura 2A ilustra un ejemplo de un eje motriz hueco o penetrador.
La figura 2B ilustra un ejemplo de un eje motriz hueco o penetrador.
La figura 2C ilustra un ejemplo de un trocar interno.
La figura 2D ilustra un ejemplo de un eje motriz hueco o penetrador.
La figura 3A ilustra un ejemplo de un accesorio.
La figura 3B es una ilustración de una realización de un accesorio.
La figura 4A es una ilustración de una realización de un eje motriz hueco y un trocar.
La figura 4B es una ilustración de una realización de un eje motriz hueco y un trocar.
La figura 4C es una ilustración de una realización de un eje motriz hueco y un trocar en una sección transversal.
La figura 4D es una ilustración de una realización de un eje motriz hueco y un trocar en una sección transversal.
Las figura 5A-C ilustran unos conjuntos de engranajes a modo de ejemplo.
DESCRIPCIÓN DETALLADA DEL APARATO
La construcción, funcionamiento y ventajas del aparato para la toma de médula ósea se comprenderán mejor
mediante la referencia a las figuras 1A-5C, en donde los números iguales se refieren a las mismas y similares
partes. La figura 1A ilustra un ejemplo de un aparato para extraer médula ósea de un hueso. El aparato 10 puede ser utilizado para obtener una muestra de médula ósea de cualquier hueso adecuado tal como una cresta iliaca o bien el esternón. El aparato 10 incluye un armazón 12, un eje 14 motriz hueco, un trocar desmontable 19, un conjunto de engranajes 37, un motor 38, y una fuente de alimentación. El armazón 12 puede incluir un conmutador de conexión/desconexión 3, un asa 5 y la guarda 6. El asa 5 puede disponerse en ángulo hacia abajo para permitir una mayor facilidad de funcionamiento y también para permitir que el eje 14 motriz hueco pueda girar sin obstrucción desde la mano. El armazón 12 abarca la fuente de alimentación 39, motor 38, y el circuito asociado 18, el eje motriz hueco 14 y el conjunto de engranajes 37. El eje motriz hueco 14 incluye el canal interior 15 y el collar 16. El engranaje 17 del conjunto de engranajes 37 se acopla al collar 16 del eje 14 del taladro hueco y por tanto hace girar el eje motriz 14 hueco.
El trocar extraíble 19 puede insertarse en el canal interno 15 del eje 14 motriz hueco. El trocar 19 es hueco y tiene un canal interno operativo para transportar las muestras de hueso y de médula ósea. El trocar 19 tiene un asa 8 que puede utilizarse para apretar el trocar 19 en posición o bien para extraerlo del canal interno 15 del eje motriz 14 hueco. El eje 14 motriz hueco puede incluir un conector de bloqueo de tipo Luer 4 en el punto en donde existe al armazón 12. El conector de bloqueo Luer puede permitir que el eje motriz pueda conectarse con un aparato de succión tal como un entubado o jeringuilla o bien a otro aparato adecuado que pueda ayudar a obtener el hueso o la muestra de la biopsia de la médula ósea. Un puerto de acceso, tal como un puerto de succión puede conectarse también en forma liberatoria a un extremo del eje motriz hueco en donde pueda salir del armazón 12, por ejemplo a un conector de bloqueo de tipo Luer. Tal accesorios puede ser un tapón, un puerto, un aparato de succión, un puerto giratorio o bien otro adaptador.
La figura 1B muestra un eje 14 motriz hueco extraído del aparato 10. En una realización, el eje 14 motriz hueco puede incluir uno o más rodamientos de empuje 21. Los rodamientos de empuje pueden absorber presión del empuje de eje motriz en el hueso durante el taladrado. Incluidos también en el eje motriz hueco se encuentran los puertos laterales mostrados con detalle adicional en la figura 2. La figura 1C ilustra el trocar desmontable 19, el cual incluye el asa 8. El asa 8 puede formarse con un perfil que pueda agarrarse haciéndole girar durante el proceso de la obtención de la biopsia. El trocar extraíble 19 puede incluir uno o más puertos operativos para tener acceso a una muestra de medula ósea mostrada con más detalle en la figura 2.
En una realización mostrada en la figura 1D, el armazón 12 puede incluir una ventanilla o puerta 12a que puede abrirse para permitir que el eje motriz hueco y el engranaje 17 fijado puedan extraerse después del uso del aparato
10. Esto puede ser deseable cuando el aparato 10 sea reutilizable y el eje 14 del taladro hueco y el trocar desmontable 19 sean desechables. Puede ser deseable también una ventanilla o puerta para limpiar el interior del aparato 10.
En una realización de la invención, que se muestra en la figura 1E, el penetrador 20 desmontable puede fijarse al eje 14 motriz hueco por los medios del conector 36 y taladrado en el hueso 2. En esta realización, el trocar desmontable puede insertarse en el canal interior 15 del eje 14 motriz hueco, y dentro del canal hueco del penetrador 20. El penetrador 20 puede incluir puertos laterales para permitir el acceso al hueso y a las muestras de la medula ósea durante una biopsia o procedimiento de recogida de la medula ósea. Una ventaja de una realización que incluye un penetrador desmontable es que permite un penetrador de varios tamaños y configuraciones para su fijación en el eje 14 motriz hueco. En esta realización, el conector 36 incluye un canal interior operativo para permitir la recuperación de las muestras de hueso o de médula ósea.
Las figuras 2A-D muestran un extremo 22 de un eje motriz hueco o un penetrador que es adecuado para penetrar un hueso. La figura 2A, ilustra un eje motriz hueco o extremo penetrador 22, el cual puede incluir múltiples puertos de muestreo 23 a través de los cuales pueden aspirarse la medula ósea o bien otros materiales de la biopsia. Los puertos de muestreo 23a, 23b y 23c son operativos cada uno para recuperar una porción de la médula ósea. Cuando el extremo 24 del trocar desmontable está en posición dentro del canal interno del extremo 22 del eje motriz hueco, el puerto 23a, 23b, o 23c pueden quedar alineados. Un operador puede determinar el nivel en la médula ósea en donde se recoge o bien el puerto de muestreo (23a, 23b o 23c) para alinear con el puerto 13 de muestreo del trocar. El eje motor hueco o el extremo penetrador 22 pueden incluir una punta aserrada 25 tal como se muestra en la figura 26 o 2B o bien cualquier otra configuración adecuada para el muestreo del hueso o médula ósea.
La figura 2C muestra un extremo 24 del trocar desmontable que tiene un puerto de muestreo 23 cerca de la punta 27, a través del cual una muestra de hueso o de médula ósea pueden recuperarse también como a través del puerto de muestreo 23a, 23b o 23c. Cuando el puerto de muestreo 23a, 23b, o 23c del eje motriz hueco o penetrador 22 está alineado con el puerto de muestreo 13 del trocar extraíble 24, puede succionarse una porción de médula ósea fuera del hueso. El trocar extraíble 24 puede retirarse permitiendo con ello que se succione la médula ósea a través de uno o más puertos de muestreo 23 del eje motriz hueco o penetrador 22 en distintos lugares en una cavidad de la medula ósea en forma secuencial. La figura 20 muestra otro ejemplo de la punta 25 del eje motriz hueco o extremo del penetrador 22, que tiene unas roscas internas 26 que son capaces de acoplar una muestra del hueso y del núcleo, conforme se taladra un eje motriz hueco o penetrador 22 dentro del hueso. Las roscas 26 pueden acoplarse y adherir a una porción del hueso o a una substancia semisólida tal como una médula ósea, y mantener contacto con la muestra de forma que pueda recuperarse con éxito.
La figura 3A muestra el mecanismo operativo 32 que puede incluirse en algunas realizaciones de la invención, y que puede fijarse al eje 14 motriz hueco y manipularse para cambiar la profundidad en una médula ósea en donde tenga lugar el muestreo. El mecanismo operativo 32 incluye el asa 35 y el engranaje 33. El engranaje 33 se acopla el engranaje 34 fijado al trocar 19. El puerto de succión 26, mostrado fijado al trocar 19, puede ser utilizado para recuperar las porciones de medula ósea del canal interno 15 del eje motriz hueco 14.
La figura 3B muestra un puerto 28 de succión del ejemplo que puede conectarse al trocar 19 en donde sale del armazón 12. En una realización un puerto de succión o aparato basculante de succión puede conectarse también al eje 14 motriz hueco. Esta función permite que el aparato de succión del tipo bien conocido por los técnicos de la técnica pueda ser utilizado para la obtención de las muestras de médula ósea. El puerto de succión 28 puede también utilizado para la conexión directamente a un penetrador a modo de un ejemplo de una realización en donde el penetrador se retira del armazón antes de tener acceso para la recuperación de la médula ósea. Se muestra también en la figura 3B un aparato basculante de succión 45 que permite que un tubo de succión 41 se fije al puerto de succión 28. El aparato basculante de succión 45 permite que el puerto de succión 28 sea fijado al tubo de succión 41, mientras que un aparato fijado de taladrado esté taladrando en la medula ósea sin plegarse o retorciendo el tubo de succión 41. Se muestra también en la figura 38 el receptáculo 43 que está interpuesto entre el tubo de succión 41 y una fuente de succión tal que pueda recuperarse una muestra de médula ósea con éxito en
5 el receptáculo 43, para que no se pierda en la máquina de succión.
La figura 4A-D muestra un ejemplo de eje motriz hueco o extremo penetrador 42 que tiene una configuración de aguja dividida. Un trocar interno 42 está insertado en un eje motriz hueco o penetrador 44. El trocar interno 42 mostrado en la posición abierta en la figura 4A se hace que avance por el extremo del eje motriz hueco o penetrador 44, en donde puede abrirse e insertándose en el hueso, médula ósea o bien otro tejido. El trocar interno 42 puede
10 estar cerrado, que se muestra en la figura 4B, de forma que una muestra pueda quedar retenida en su agarre conforme sea retirada del cuerpo. La figura 4C muestra una sección transversal del trocar 42 interno de aguja dividida, en donde la punta del trocar 42 interno está en la posición abierta. La figura 4D muestra una sección transversal del trocar 42, que se muestra en la posición cerrado.
El aparato puede o no incluir un conjunto de engranajes de reducción. El conjunto de engranajes de reducción
15 puede incluir un conjunto de engranajes sin fin que se muestra con más detalles en la figura 5A, y que puede incluir un primer conector 50 que conecta el eje 52 del motor 38 al engranaje sin fin 54. Puede utilizarse un conjunto de engranaje de reducción para reducir el número de revoluciones por minuto entre el motor y el conjunto del penetrador, para proporcionar un número óptimo de revoluciones por minuto en el punto de inserción del conjunto del penetrador dentro del hueso. La figura 5B ilustra una realización adicional de un conjunto de engranajes de
20 reducción en donde un primer engranaje 57 está acoplado a un segundo engranaje 58. La figura 5C ilustra una realización alternativa de un conjunto de engranajes de reducción en donde el engranaje 56 tiene un desplazamiento de cuarenta y cinco grados con respecto al eje 14 motriz hueco, que puede ser preferible en algunas realizaciones. En esta realización el engranaje 58 puede estar desplazado en cualquier ángulo y no puede no estar limitado a los cuarenta y cinco grados. Pueden utilizarse otros engranajes en un conjunto de engranajes de
25 reducción, por ejemplo un engranaje planetario (no se muestra expresamente) solo o en combinación con un engranaje sin fin o recto.
Aunque la presente invención y sus ventajas se han descrito con detalle, se comprenderá que pueden realizarse varios cambios, sustituciones y alternativas, sin desviarse del alcance de la invención y según lo definido por las reivindicaciones siguientes.
Claims (13)
- REIVINDICACIONES1. Un aparato para la extracción de porciones de hueso y médula ósea a partir de un hueso para los fines de diagnóstico y de tipo terapéutico, que comprende:un armazón (12);un eje (14) motor hueco dispuesto en el armazón (12) y operativo para acoplar un conjunto de engranajes (37);el conjunto de engranajes (37) es operativo para girar el eje (14) motor hueco; un penetrador (20) operable para penetrar la médula ósea y recogiendo las muestras de la médula ósea;un motor (38) acoplado al eje motor hueco y operable para accionar el penetrador (20) mencionado dentro de la médula ósea por la rotación del eje motor hueco;una fuente de alimentación (39) y un circuito asociado operable para alimentar el motor (38); un trocar interior (19) que se extiende por un canal interno (15) del eje motriz (14) y un conducto a través del penetrador (20) por lo que un primer extremo del mencionado trocar es operable para penetrar la médula ósea y teniendo un segundo extremo, en donde el trocar (19) interno es desmontable del canal interno (15) y el conducto y un conector (36) que son operables para fijar en forma desmontable el mencionado penetrador (20) al extremo distal del eje motor hueco;en donde el motor y el eje motor hueco (14) están caracterizados porque el eje motor hueco (14) comprenden un canal interno (15) operable para desplazar las porciones de la médula ósea a un operador, y un extremo proximal operable para permitir la recuperación de las porciones de la médula ósea.
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- 2.
- El aparato de la reivindicación 1, en donde el trocar interno (19) comprende una punta (27) que tiene una ranura longitudinal operable para liberar los trozos de hueso de un punto de inserción dentro de la médula ósea.
-
- 3.
- El aparato de la reivindicación 1 ó 2 en donde el segundo extremo del eje (14) motor hueco comprende un puerto de acceso operable para utilizarse para obtener porciones del hueso y de la médula ósea del canal interno (15).
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- 4.
- El aparato de acuerdo con cualquiera de las reivindicaciones anteriores en donde el segundo extremo del eje (14) motor hueco comprende un puerto de succión (28) para poder retirar las porciones de hueso y de la médula ósea en un receptáculo.
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- 5.
- El aparato de acuerdo con cualquiera de las reivindicaciones anteriores en donde el segundo extremo del trocar interno (19) comprende un engranaje con trinquete operable para controlar la profundidad de muestreo de la médula ósea.
-
- 6.
- El aparato de acuerdo con cualquiera de las reivindicaciones anteriores en donde el penetrador (20) comprende unas roscas internas operativas para acoplar al hueso o médula ósea conforme el penetrador
(20) se taladra dentro del hueso. -
- 7.
- El aparato de acuerdo con cualquiera de las reivindicaciones anteriores en donde el trocar interno (19) comprende dos cuerpos longitudinales separados que pueden moverse conjuntamente para el agarre de una muestra de biopsia.
-
- 8.
- El aparato de acuerdo con cualquiera de las reivindicaciones anteriores en donde el conjunto (37) de engranajes comprende un conjunto de engranajes de reducción.
-
- 9.
- El aparato de acuerdo con cualquiera de las reivindicaciones precedentes en donde el eje motriz hueco (14) comprende al menos un rodamiento de empuje.
-
- 10.
- El aparato de acuerdo con cualquiera de las reivindicaciones anteriores en donde el penetrador (20) comprende al menos un puerto de acceso lateral.
-
- 11.
- El aparato de acuerdo con cualquiera de las reivindicaciones anteriores en donde el trocar (19) interno desmontable comprende al menos un puerto lateral para alinearse con un puerto lateral del penetrador (20).
-
- 12.
- El aparato de acuerdo con cualquiera de las reivindicaciones anteriores, en donde el eje (14) motor hueco comprende un conector (4) de bloqueo de tipo Luer.
-
- 13.
- El aparato de la reivindicación 1 que comprende un armazón (12) que incluye una ventanilla o puerta desmontable (12a) por lo que el eje motor hueco (14) puede instalarse y desmontarse.
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2010
- 2010-02-05 US US12/701,268 patent/US20100137740A1/en not_active Abandoned
- 2010-03-05 US US12/718,606 patent/US8480632B2/en active Active
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2013
- 2013-01-04 JP JP2013000197A patent/JP5953238B2/ja not_active Expired - Lifetime
- 2013-08-13 US US13/966,104 patent/US9314270B2/en not_active Expired - Fee Related
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2014
- 2014-05-06 US US14/271,144 patent/US8992535B2/en not_active Expired - Lifetime
- 2014-11-04 US US14/532,635 patent/US10456149B2/en active Active
-
2015
- 2015-03-24 US US14/666,391 patent/US9393031B2/en not_active Expired - Lifetime
-
2016
- 2016-03-08 US US15/064,175 patent/US10893875B2/en not_active Expired - Lifetime
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2019
- 2019-10-25 US US16/664,282 patent/US20200054350A1/en not_active Abandoned
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2020
- 2020-03-17 US US16/821,627 patent/US11324521B2/en not_active Expired - Lifetime
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