ES2425392T3 - Cartucho para un aparato de inhalación - Google Patents
Cartucho para un aparato de inhalación Download PDFInfo
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- ES2425392T3 ES2425392T3 ES07022752T ES07022752T ES2425392T3 ES 2425392 T3 ES2425392 T3 ES 2425392T3 ES 07022752 T ES07022752 T ES 07022752T ES 07022752 T ES07022752 T ES 07022752T ES 2425392 T3 ES2425392 T3 ES 2425392T3
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0091—Inhalators mechanically breath-triggered
- A61M15/0093—Inhalators mechanically breath-triggered without arming or cocking, e.g. acting directly on the delivery valve
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0021—Mouthpieces therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0021—Mouthpieces therefor
- A61M15/0025—Mouthpieces therefor with caps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/06—Inhaling appliances shaped like cigars, cigarettes or pipes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
- A61M2202/064—Powder
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2206/00—Characteristics of a physical parameter; associated device therefor
- A61M2206/10—Flow characteristics
- A61M2206/16—Rotating swirling helical flow, e.g. by tangential inflows
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Abstract
Un cartucho (32) para su uso en un aparato de inhalación (20) en el que dicho aparato de inhalación (20)comprende una boquilla (26) que comprende un ánima central (40), comprendiendo el cartucho una porción decabeza (102), una porción posterior (104) y una cámara (110) para almacenar una sustancia inhalable; en donde elcartucho (32) incluye adicionalmente al menos una porción de recepción en el ánima central (40) de la boquilla (26);en donde el cartucho (32) se puede girar desde una primera posición en la que la cámara (110) está cerrada a unmedio ambiente, a una segunda posición, donde se ha abierto una trayectoria de flujo desde el medio ambiente através de la cámara (110), cuando el cartucho (32) se inserta dentro del ánima central (40) de la boquilla (26); y endonde el cartucho (32) comprende estructuras configuradas para engancharse con el aparato de inhalación y pararetener la segunda posición una vez se haya alcanzado la segunda posición, caracterizado porque el cartucho (32)comprende un conducto de entrada (112) para la toma de aire, comprendiendo el conducto de entrada un canal dealimentación (114) y un tubo de colimación (116), extendiéndose el tubo de colimación (116) dentro de la cámara ycomprendiendo el cartucho (32) adicionalmente al menos un saliente (132) y dos o más bordes (130a, 130b) quejunto con el tubo de colimación (116) en uso crean vórtices desde la corriente de aire a través del tubo de colimacióncuando el cartucho (32) está en la segunda posición.
Description
Cartucho para un aparato de inhalación
Campo técnico
La presente invención está dirigida a inhaladores, y en particular a inhaladores de polvo seco y forma un cartucho para su uso en un aparato de inhalación.
Antecedentes
Los inhaladores o dispositivos de inhalación que entregan su contenido en forma de neblina líquida y de polvo en forma de aerosol, son hoy de uso común. Sin embargo, estos inhaladores empleaban por lo general propelentes cuya eficiencia depende de la presión, y por tanto, de la altitud y de la atmósfera. Adicionalmente, propelentes como los de clorofluorocarbono están prohibidos por los tratados, ya que son perjudiciales para el medio ambiente.
Por consiguiente, se desarrollaron inhaladores de polvo seco o dispositivos de inhalación. Sin embargo, estos inhaladores de polvo seco eran de uso limitado, sobre todo cuando se deseaba la transmisión del medicamento a la parte profunda del pulmón.
Estos inhaladores de polvo seco presentaban desventajas en que su diseño producía partículas que se movían demasiado rápido o se aglomeraban. Cuando las partículas viajaban demasiado rápido, generalmente alcanzaban la parte posterior de la garganta, donde eran absorbidas, sin llegar nunca a los pulmones. De forma similar, las partículas que se aglomeraban eran demasiado pesadas, y por lo general caían fuera de la corriente de respiración inhalada en la boca o cavidad bucal, donde eran tragadas sin que alcanzaran nunca los pulmones. Por consiguiente, si algo de polvo llegaba a los pulmones era generalmente en cantidades ineficaces para un tratamiento apropiado.
Además, estos inhaladores convencionales son relativamente grandes. Como resultado de su gran tamaño, su portabilidad en bolsillos y otros compartimientos es limitada, y en buena medida, el espacio requerido para su uso es grande. Por ejemplo, el espacio requerido para el uso de estos inhaladores convencionales haría difícil, si no imposible, usarlos bajo una máscara de gas o similar, ya que el espacio de aire en ella está sumamente limitado. Unido a la cantidad de espacio que ocupan en bolsillos, equipos de primeros auxilios, etc., muchos de estos inhaladores convencionales no son recomendados para el campo de batalla y otros usos de emergencia. La Patente de Estados Unidos Nº 5.394.868 desvela un dispositivo de inhalación en el cual una cámara que descarga sustancias está fijada a una boquilla. Un mecanismo de base se mueve con relación a la cámara para cargar ésta con la sustancia de inhalación en una operación subsiguiente que sigue al movimiento posterior del mecanismo de base.
La estructura del dispositivo del documento US 5.394.868 es compleja, y no se presta en sí misma para un uso económico como un artículo de una sola dosis.
El documento WO-A-97/30743 desvela una configuración similar, en la cual se usan partes giratorias para cargar una cámara que está fijada a una boquilla.
El documento EP 1 068 871 A1 desvela un medicador inhalante adecuado para prescribir medicamentos granulados
o en polvo dentro de los pulmones de un paciente mediante la acción respiratoria del paciente. También describe un miembro cilíndrico de almacenamiento del polvo médico.
En el documento US 4.338.931 A se muestra un dispositivo para la inhalación de un medicamento en forma de polvo en el que el medicamento se encuentra en una cápsula que comprende dos miembros conformados en forma cilíndrica donde al menos uno de ellos dispone de medios huecos de perforación.
El documento US 5.562.918 A describe una cápsula de medicamento que comprende un manguito que forma una pared lateral de la cápsula y que tiene una primera y una segunda tapa de cierre que cierra los extremos abiertos del manguito mientras que el documento WO 99/04840 A analiza un inhalador farmacéutico con una boquilla y una tapa que están conectadas de forma giratoria entre sí.
Sumario
Según un primer aspecto de la invención se proporciona un cartucho de acuerdo con la reivindicación 1.
Sumario
La invención es como se define en las reivindicaciones adjuntas.
El aparato, los componentes y los procedimientos desvelados en el presente documento mejoran la técnica actual, proporcionando un inhalador de polvo seco cuyos contenidos pueden alcanzar los pulmones en cantidades eficaces para el tratamiento de varias dolencias. El aparato desvelado en el presente documento incluye un inhalador (pieza de inhalación) que utiliza la respiración del usuario para pasar el polvo seco desde el cuerpo del dispositivo a los
pulmones del usuario, eliminando la necesidad de propelentes. Por consiguiente, el inhalador desvelado en el presente documento puede usarse sin tener en cuenta la altitud y las condiciones atmosféricas.
El inhalador desvelado en el presente documento tiene una configuración tal que, cuando la respiración del usuario alcanza un índice de flujo predeterminado suficiente, el polvo seco contenido en él se desaglomerará. Estas partículas de polvo seco no aglomeradas entran entonces en la corriente de respiración inhalada, permitiendo así que los contenidos del inhalador alcancen los pulmones en cantidades eficaces.
El inhalador es pequeño y compacto. Este tamaño pequeño posibilita su uso en espacios pequeños. Por ejemplo, el inhalador puede ponerse debajo, o insertarse en una máscara de gas u otro dispositivo de protección, utilizando el espacio de aire cerrado del mismo sin interrumpir su función. El inhalador puede ser también de usos únicos o de un solo uso y puede ser desechable.
El inhalador se activa al instante al extraerlo de una cubierta o unidad de cubierta. El inhalador se separa de la cubierta empujándolo simplemente en una dirección hacia fuera de la cubierta o por rotación, si está presente un mecanismo de rosca en forma de hélice entre la cubierta y el inhalador. Girando un componente de cartucho del inhalador, donde el medicamento del inhalador se guarda en una cámara, se abre un canal desde esta cámara al entorno. Además, la cámara de almacenamiento se abre a la boquilla, proporcionando acceso inmediato a los contenidos de la cámara para su inmediata inhalación.
El inhalador es higiénico y sus contenidos están protegidos hasta que se usan, mientras la boquilla y la abertura al medio ambiente están bajo una cubierta que pone el cuerpo del inhalador en una configuración de bloqueo hasta que se desee usarlo. Cada inhalador puede estar cubierto individualmente, o las cubiertas individuales pueden unirse para hacer una sola unidad formada por cubiertas múltiples con los correspondientes inhaladores.
Descripción breve de los dibujos
Ahora se dirige la atención a las figuras de dibujos, donde números o caracteres de referencia similares indican componentes correspondientes o similares. En los dibujos:
La Fig. 1 es una vista isométrica de una realización del aparato desvelado en el presente documento como una
sola unidad;
La Fig. 2 es una vista en despiece del dispositivo de la Fig. 1;
La Fig. 3A es una vista isométrica de la boquilla de la Fig. 2;
La Fig. 3B es una vista frontal de la boquilla de la Fig. 2;
Las Figs. 3C y 3D son vistas laterales de la boquilla de la Fig. 2;
La Fig. 3E es una vista posterior de la boquilla de la Fig. 2;
La Fig. 4 es una vista de la sección transversal del aparato de la Fig. 1 mostrándolo en una posición cerrada;
La Fig. 5A es una vista de la boquilla de la Fig. 3D, tomada a lo largo de la línea 5A-5A;
Las Figs. 5B, 5C, 5D son vistas de la sección transversal de la Fig. 5A, tomadas a lo largo de las líneas 5B-5B,
5C-5C y 5D-5D, respectivamente;
La Fig. 6A es una vista frontal del cartucho de la Fig. 2;
La Fig. 6B es una vista del cartucho de la Fig. 6A tomada a lo largo de línea 6B-6B;
La Fig. 6C es una vista en despiece del cartucho de la Fig. 6A;
La Fig. 7A es una vista frontal del aparato de la Fig. 1 con la cubierta reposicionada en la parte del inhalador;
La Fig. 7B es una vista de la sección transversal del aparato de la Fig. 7A tomada a lo largo de la línea 7B-7B;
La Fig. 8 es una vista isométrica de una segunda realización de un aparato desvelado en el presente
documento; y
La Fig. 9 es una vista isométrica de la realización de la Fig. 8, mostrando la extracción de la parte del inhalador.
Descripción detallada de los dibujos
Las Figs. 1 y 2 muestran un aparato 20 formado por una parte de inhalador 22 (inhalador) y una cubierta 24. La parte de inhalador 22 incluye una boquilla 26, formada por una sección de tubo 28 y una sección de cuerpo 30, y un cartucho 32. La boquilla 26 incluye un ánima interior 40 (Figs. 4 y 5A) para recibir el cartucho 32 en una unión de fricción y rotación, permitiendo la rotación del cartucho 32 con respecto a la boquilla 26, y viceversa (de acuerdo con la doble flecha 41). Esta unión se mantiene mediante pestañas 44 (Figs. 4 y 5A), 45 dispuestas de manera correspondiente en la boquilla 26 y en el cartucho 32, que se unen entre sí. Ambos, la boquilla 26 y el cartucho 32, incluyen las secciones de cuello acanalado 48, 49 para facilitar el agarre por parte del usuario, a fin de girar el cartucho 32 en la boquilla 26.
La cubierta 24 generalmente se une a la parte de inhalador 22 en la caña 52 de la boquilla 26. Esta caña 52 es generalmente de un diámetro sólo ligeramente menor que el correspondiente diámetro interno de la cubierta 24 (entre las superficies interiores 53 de la cubierta 24). La caña 52 también incluye por lo menos un rebaje 54, para acoplar el(los) saliente(s) 57 formados de manera correspondiente, extendiéndose normalmente de forma continua alrededor de la superficie interior 53 (Fig. 4) de la cubierta 24. Las dimensiones de la caña 52 y de la cubierta 24, ligadas al rebaje 54 y al/los saliente(s) 57 correspondiente(s), permiten retener la cubierta 24 sobre la boquilla 26 en una unión por fricción, donde quitar la cubierta 24 de la boquilla 26 requiere un esfuerzo mínimo. La cubierta 24
puede incluir un agarre estriado cilíndrico 58 para los dedos que ayuda al usuario a agarrar la cubierta 24 cuando se desea usar la parte del inhalador 22.
La cubierta 24 y la boquilla 26 están normalmente diseñadas de modo que no es posible volver a fijar la cubierta 24 a la boquilla 26, ya que el rebaje 54 o el(los) saliente(s) 57 se dañan durante la separación de la cubierta 24, por lo cual no volverán a servir para mantener el acoplamiento antes mencionado. Como alternativa, la cubierta 24 y la boquilla 26 podrían incluir partes de rosca como estructuras, una de las cuales por lo menos se quita en la separación de la parte de inhalador 22 de la cubierta 24, o cualquiera de la cubierta 24 o de la boquilla 26 incluyen estructuras tipo trinquete en un solo sentido que dañan la mencionada separación. Esto asegura que la sección de inhalador 22 será un dispositivo de un solo uso en una sola vez. Por lo tanto, probar el aparato 20 para asegurarse de que no se ha usado, simplemente implica voltear el aparato 20 al revés, con la cubierta 24 apuntando al suelo. Si la cubierta 24 cae fácilmente, esto es una indicación cierta de que la parte de inhalador 22 se ha usado.
Volviendo también a las Figs. 3A-3E y 4 (el aparato 20 se muestra en la posición cerrada o recogida en la Fig. 4), el puerto 60, se extiende a través de la caña 52. El puerto 60 incluye una abertura de admisión 62 (a través de la cual el aire del entorno entra en la parte de inhalador 22) encima de la cual se extiende la cubierta 24. Esto permite separar la parte de inhalador 22 de la cubierta simplemente fracturándola/desprendiéndola o bien torciéndola o girándola (en la dirección de la doble flecha 63), si se emplea un sistema de enrosque mecánico (por ejemplo, una unión de rosca tipo hélice) entre la parte de inhalador 22 y la cubierta 24.
La cubierta 24 se extiende sobre y en la abertura de admisión 62 y el puerto 60, de tal manera que la caña 52 encaja más allá de la abertura de admisión 62, ya que se desea que el puerto 60 y la abertura de admisión estén bajo la cubierta y no expuestos al entorno hasta el uso (es decir, la separación de la parte de inhalador 22 de la cubierta 24). Estando bajo la cubierta se minimiza la probabilidad de que las partículas de polvo u otras partículas pudieran llegar al interior del puerto 60 y obstruirlo. El puerto 60 es, por ejemplo, rectangular en su sección transversal, con otras formas de secciones transversales, como la redonda, también apropiadas. El puerto 60 termina en una abertura interior 64, que se corresponde en forma y dimensiones con la abertura 122 (Fig. 6B) en el cartucho 32.
La boquilla 26, en su sección tubular 28 incluye la caña 52, con un tubo de descarga 70 de partículas (desde la cámara 110, detallada más abajo), que se extiende por todo lo largo. Como se muestra en la Fig. 5A, el tubo 70 incluye una abertura 72, normalmente una abertura redondeada o circular en su extremo interior 73. Trasladándose al exterior, el tubo 70 tiene una porción de diámetro constante 74, seguida por una porción ahusada 76 y una porción recta 78, terminando en una abertura 80, en el extremo exterior 81 a través de la cual las partículas abandonan la parte de inhalador 22 y entran en la cavidad bucal de un usuario. Estas tres partes 74, 76 y 78, se unen a las agregaciones de las partículas residuales no aglomeradas dentro del flujo de partícula y controlan la velocidad a la cual se descargaron las mismas en la cavidad bucal. Adicionalmente, las longitudes de cada porción 74, 76 y 78 se optimizan de manera tal que no aumente la separación de flujo (flujo hacia atrás que crea vórtices o remolinos).
La porción de diámetro constante 74 es de un diámetro constante y de una longitud suficiente para proporcionar a las partículas un tubo de entrada directo para la aceleración de partículas/gas y el desarrollo de un campo de flujo de cizallamiento elevado. Esta porción es normalmente ovalada o redondeada en la sección transversal, como se muestra en la Fig. 5B. Esta geometría permite la eliminación de la mayoría de las partículas residuales aglomeradas.
La porción ahusada 76 se estrecha exteriormente (hacia la abertura exterior 80), normalmente en ángulos de aproximadamente 3 a 7 grados, y por ejemplo aproximadamente de 4 grados para alcanzar, por ejemplo, una relación entre dimensiones de 2:1. En esta relación entre dimensiones, puede haber transición de la velocidad de la corriente de la partícula que viaja en este tubo 70. Esta porción 76 ahusada se origina, por ejemplo, con una sección transversal ovalada (Fig. 5B) y se estrecha exteriormente en una sección transversal en forma de judía o riñón, como se muestra en la Fig. 5C.
La porción recta 78 es de dimensiones constantes. Esto permite la colimación y el control de la velocidad de la corriente de la partícula que abandona el tubo 70. Esta porción 78 tiene normalmente forma de judía o riñón en la sección transversal, como se muestra en la Fig. 5D, similar a la de la abertura 80. Sin embargo, también son posibles otras formas, con tal de que permitan el control de la velocidad de la corriente de la partícula.
Un bulbo 86 en el exterior de la sección tubular 28, normalmente un óvalo levantado u otra forma redondeada, funciona como depresor de la lengua, así como el localizador del tubo de descarga de la boquilla. Específicamente, como se muestra en detalle en las Figs. 3C-3E, 4 y 7B, esta forma y estas dimensiones para el bulbo 86 mantienen la lengua abajo, para no bloquear el flujo de partículas en la boca (cavidad bucal). La caña 52, en particular donde es de mayor diámetro que el tubo 70, sirve como superficie tope para el apoyo de los labios del usuario, permitiendo a los labios formar un sello alrededor de la sección tubular 28 en este punto para la succión, a fin de reforzar la inhalación. Como alternativa, puede haber un saliente en la sección tubular 28, en el lado contrario al bulbo 86 (es decir, depresor de la lengua), que sirve como superficie tope para los labios, permitiendo a los labios formar un sello alrededor de la sección tubular 28 en este punto de succión, a fin de reforzar la inhalación.
El ánima interior 40 de la boquilla 26 está formado en correspondencia con la forma de la porción de cabeza 102 (Figs. 6A-6C) del cartucho 32. Esta ánima 40 incluye una hendidura dentada 90 (Figs. 4 y 7B) que permite a una
llave 154 dimensionada de manera correspondiente del cartucho 32 ser retenida ahí, mientras que se permiten los giros de hasta 90 grados del cartucho 32 en la boquilla 26 a fin de que la parte de inhalador 22 se mueva de la posición de cerrado o recogido (mostrada en la Fig. 4), a la posición abierta o de inhalación (mostrada en las Figs. 7A y 7B), para la inhalación y el transporte de partículas a los pulmones. Los dientes (no mostrados), normalmente posicionados a 90 grados unos de otros, se extienden dentro de la superficie 94 del ánima interior 40. Estos dientes están configurados de modo cooperativo para enganchar los bordes 150 al cartucho 32, después de que el cartucho 32 gira a la posición abierta (detallada más abajo). Estos dientes incluyen en general bordes radiales o redondeados, que permiten el movimiento del cartucho 32 con respecto a la boquilla 26 (y viceversa), entre las posiciones de abierto y cerrado. Como alternativa, estos dientes, si se proporcionan con bordes cuadrados o afilados, serán de un solo sentido, no permitiendo, así, el movimiento hacia atrás a la posición cerrada (Fig. 4) desde la posición abierta (Fig. 7B), con lo cual el aparato 20 es un aparato de un solo uso o de una sola vez.
Las Figs. 6A-6C muestran el cartucho 32 en detalle. El cartucho 32 está formado por lo general de una porción de cabeza 102 y una porción posterior 104, que pueden estar juntos en un montaje por fricción de chasquido, soldadura
o unión por otras técnicas y/o mecanismos de fijación convencionales. Las porciones de cabeza 102 y posterior 104 cuando se juntan alojan en su interior combinado una cámara 110.
Un conducto de entrada 112 para la toma del aire se extiende dentro de la cámara 110, en la porción de cabeza 102. Este conducto de entrada 112 está formada por un canal de alimentación 114, formado de manera correspondiente con respecto al puerto 60, para la alineación cuando la parte de inhalador 22 está en la posición abierta, y un tubo de colimación 116, que se extiende desde el canal de alimentación 114 (a través de la abertura 117a) en la cámara 110 (a través de la abertura 117b).
Un tubo de salida 118 para las partículas se extiende desde la cámara 110 (a través de la abertura 119) hasta la superficie exterior 120 del cartucho 32. Este tubo de salida 118 termina en una abertura 122 dimensionada para corresponderse con la abertura 72 en la boquilla 26 para el flujo de partícula que lo atraviesa, cuando el cartucho 32 y la boquilla 26 están alineados con la parte de inhalador 22 estando en la posición abierta (Fig. 7).
Dentro de la cámara 110, están los bordes 130a, 130b, normalmente de forma redondeada. En la porción posterior 104, los bordes 130b se extienden para formar un saliente central 132. Este saliente 132 tiene normalmente forma de cono, y unido a los bordes 130a, 130b, crea los vórtices para las partículas (representadas por flechas 134) de la corriente de aire a través del tubo de colimación 116 (representado mediante las flechas 136). Mediante la creación de los vórtices, las partículas se desaglomeran y se suspenden en una concentración del aerosol impelido seco uniforme. Esto aumenta al máximo vaciando la cámara 110 eficazmente y permite a las partículas ser introducidas en el flujo de la respiración.
Dentro de esta cámara 110, se mantiene el inhalante, que está normalmente en forma de polvo seco. Este inhalante puede ser por ejemplo molécula(s) bioactiva(s) encapsulada(s) en partículas Technosphere® de la Corporación Mannkind, Valencia, California, 91355, como se describe en el documento US 2004/018152, o atropina, antibióticos, como la penicilina, doxiciclina, ciprofloxacina y fluoroquinolonas, encapsuladas en partículas Technosphere®, estas partículas Technosphere® y los procedimientos para su fabricación se desvelan en las Patentes de Estados Unidos Nº 5.352.461, 5.503.852 y 6.071.497.
La porción de cabeza 102 está formada generalmente por una porción cilíndrica 140, una porción cónica 142 (por ejemplo a aproximadamente un ángulo de 60-70 grados), y una porción discoidal 144, encima de la porción cónica
142. Las pestañas 45 se extienden normalmente alrededor de la porción cilíndrica 140 para acoplarse de este modo con las correspondiente pestañas 44 de la boquilla 26, y mantienen la unión por fricción y rotación del cartucho 32 y la boquilla 26 como se detalló anteriormente. La porción cónica 142 incluye una abertura 146 para el canal de alimentación 114, que es normalmente rectangular para lograr el control óptimo del flujo, así como la abertura 122 para el tubo de salida 118.
Los bordes 150, sobresalen una ligera distancia de la superficie 151 de la porción cónica 142. Ampliando esta ligera distancia unido al material del cartucho, y por lo tanto al borde 150, los bordes 150 se comportan en una forma parecida a un resorte. Los bordes 150 son normalmente de puntas 152 cuadradas o afiladas, pero también podrían ser radiales o redondeados en sus bordes. Los bordes 150 están dimensionados de manera correspondiente a las aberturas 64, 72 de la boquilla 26, en donde ellos se asientan cuando el aparato 20 está en la posición cerrada. (Las aberturas 64, 72 incluyen normalmente bordes radiales o redondeados para permitir la rotación del cartucho 32 en la boquilla 26 desde la posición cerrada a abierta). Los bordes 150 finalmente descansan en los dientes (como se detalló anteriormente), con el comportamiento en forma de muelle de los bordes 150 proporcionando la sensación táctil de que el cartucho 32 y la boquilla 26 no están ya más unidos en la posición inicial cerrada y se ha alcanzado la posición abierta. Estos bordes 150 se sitúan normalmente a 180 grados unos de otros (aunque también son posibles otros posicionamientos), estos 180 grados correspondiendo a las posiciones de las aberturas 64, 72 de la boquilla y los respectivos dientes en la boquilla 26.
Una llave 154 se extiende desde la porción discoidal 144. La llave 154 tiene normalmente forma de media luna, y encaja dentro de la hendidura 90 (Figs. 4 y 7B) en la boquilla 28, sirviendo la hendidura 90 como límite para la llave 154, y en consecuencia, tiene el espacio suficiente para limitar la rotación del cartucho 32 con respecto a la boquilla 26 (y viceversa) a por ejemplo 90 grados (para que la rotación sea entre las posiciones abierta y cerrada).
La porción posterior 104 incluye la sección de cuello acanalada 49, como se detalló anteriormente. Adicionalmente, están las roscas 158 o dientes del anillo al final de la porción posterior 104, que se pueden unir con las correspondientes roscas 159 o bordes en la cubierta 24, para mantener la cubierta en la sección de inhalador 22. Como alternativa, esta sección de la porción posterior 104 y la porción correspondiente de la cubierta 24 pueden dotarse de un bloqueo permanentemente una vez unidas, provocando así el uso una sola vez del aparato 20, como se muestra en las Figs. 7A y 7B. Sin embargo, esta unión de la cubierta 24 a la porción posterior 104 es opcional, ya que el funcionamiento normal de la parte de inhalador 22 no requiere que la cubierta 24 se una a la porción posterior
104.
Todos los componentes mencionados anteriormente, la cubierta 24, la boquilla 26 y el cartucho 28, y todas las estructuras situadas encima y/o en su interior están normalmente hechos de plásticos, polímeros, o similares, siendo uno de tales plásticos el plástico acetal, por ejemplo los plásticos DELRIN® 500 y "Antiestático" CELCON®. Aunque se citan estos plásticos, otros múltiples plásticos, polímeros y otros materiales son también apropiados para los componentes mencionados en el presente documento. Estos plásticos, polímeros y otros materiales pueden seleccionarse, por ejemplo, basándose en la composición que estará en la cámara 110, a los factores medioambientales y de almacenamiento y similares. Estos componentes se forman normalmente por medio de técnicas tales como el moldeo y por ejemplo, el moldeo por inyección.
Volviendo específicamente a las Figs. 7A y 7B, está detallada la parte de inhalador 22 en una posición abierta, lista para su uso (inhalación de los contenidos de la cámara 110). Como se muestra aquí, el canal de alimentación 114 y el tubo de salida 118 se posicionan en el cartucho 32, que habiendo sido girados, están alineados respectivamente con el puerto 60 de entrada y el tubo de descarga 70. Esta alineación en la posición abierta crea una trayectoria de flujo para la inhalación, desde la abertura 62 de entrada (para la toma de aire del medio ambiente), a través de la cámara 110, donde se crea un flujo de partículas, y a través del tubo de descarga 70 de la boquilla 26, donde el flujo de partículas se inhala para la entrega final a los pulmones, incluso a la zona más profunda de los pulmones. El puerto 60 de entrada, unido al canal de alimentación 114, y el tubo de salida 118, están normalmente angulados a un ángulo Θ, estando a aproximadamente de 0 a 180 grados el uno del otro, y por ejemplo, aproximadamente 45 grados, para evitar grandes contrapresiones, que inhiben el flujo de aire a lo largo de la trayectoria del flujo.
Las Figs. 8 y 9 muestran un sistema de múltiples unidades 200. Aquí, las partes 222 únicas del inhalador, similares en todos los aspectos a las partes de inhalador 22 (detalladas anteriormente), están en las cubiertas 224, similares a las cubiertas 24 (detalladas anteriormente), que se unen como una sola unidad. Las cubiertas 224 incluyen partes poco resistentes 227 y aberturas 229 entre ellas, permitiendo la separación fácil en unidades 20’ individuales.
Claims (6)
- REIVINDICACIONES1. Un cartucho (32) para su uso en un aparato de inhalación (20) en el que dicho aparato de inhalación (20) comprende una boquilla (26) que comprende un ánima central (40), comprendiendo el cartucho una porción de cabeza (102), una porción posterior (104) y una cámara (110) para almacenar una sustancia inhalable; en donde el 5 cartucho (32) incluye adicionalmente al menos una porción de recepción en el ánima central (40) de la boquilla (26); en donde el cartucho (32) se puede girar desde una primera posición en la que la cámara (110) está cerrada a un medio ambiente, a una segunda posición, donde se ha abierto una trayectoria de flujo desde el medio ambiente a través de la cámara (110), cuando el cartucho (32) se inserta dentro del ánima central (40) de la boquilla (26); y en donde el cartucho (32) comprende estructuras configuradas para engancharse con el aparato de inhalación y para 10 retener la segunda posición una vez se haya alcanzado la segunda posición, caracterizado porque el cartucho (32) comprende un conducto de entrada (112) para la toma de aire, comprendiendo el conducto de entrada un canal de alimentación (114) y un tubo de colimación (116), extendiéndose el tubo de colimación (116) dentro de la cámara y comprendiendo el cartucho (32) adicionalmente al menos un saliente (132) y dos o más bordes (130a, 130b) que junto con el tubo de colimación (116) en uso crean vórtices desde la corriente de aire a través del tubo de colimación15 cuando el cartucho (32) está en la segunda posición.
- 2. Un aparato de inhalación (20) con el cartucho (32) de la reivindicación 1, en el que el aparato de inhalación (20) comprende una cubierta (24), estando adaptada la cubierta (24) para cubrir la boquilla (26), en donde la cubierta (24) y la boquilla (26) incluyen estructuras (54, 57) configuradas en cooperación para retener la cubierta (24) enganchada con la boquilla (26), una vez que la cubierta (24) se ha situado en la boquilla (26).
- 20 3. El cartucho (32) de la reivindicación 1, en el que la porción de cabeza (102) comprende una porción cilíndrica, en el que pestañas (45) se extienden alrededor de la porción cilíndrica, y en el que las pestañas (45) se enganchan con las pestañas (44) correspondientes de la boquilla (26) cuando el cartucho se engancha con la boquilla (26).
- 4. El cartucho (32) de la reivindicación 3, en el que el tubo de colimación (116) en uso dirige la corriente de aire a un saliente (132) de la cámara (110).
- 25 5. El cartucho (32) de la reivindicación 1, en el que la porción posterior (104) comprende un saliente central (132).
-
- 6.
- El cartucho (32) de la reivindicación 1, en el que el saliente central (132) está conformado en forma de cono.
-
- 7.
- El cartucho (32) de la reivindicación 1, en el que la porción de cabeza (102) y el ánima central (40) de la boquilla
(26) están conformados con una forma correspondiente. - 8. El aparato de inhalación (20) de la reivindicación 2, en el que la cubierta (24) está adaptada para enganchar la 30 porción posterior (104) del cartucho (32).
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US20120247464A1 (en) | 2012-10-04 |
WO2003080149A3 (en) | 2004-02-05 |
EP1894591A3 (en) | 2008-10-29 |
US8166970B2 (en) | 2012-05-01 |
US20050188988A1 (en) | 2005-09-01 |
CA2479751C (en) | 2008-06-03 |
AU2003220125B2 (en) | 2006-06-15 |
ES2300568T3 (es) | 2008-06-16 |
EP1894591B1 (en) | 2013-06-26 |
EP1494732A2 (en) | 2005-01-12 |
ATE385193T1 (de) | 2008-02-15 |
DE60318938T2 (de) | 2009-01-22 |
JP2005520641A (ja) | 2005-07-14 |
EP1494732B1 (en) | 2008-01-30 |
DE60318938D1 (de) | 2008-03-20 |
PT1494732E (pt) | 2008-03-20 |
US6923175B2 (en) | 2005-08-02 |
CY1108072T1 (el) | 2014-02-12 |
EP1894591A2 (en) | 2008-03-05 |
US20030209245A1 (en) | 2003-11-13 |
HK1116106A1 (en) | 2008-12-19 |
AU2003220125A1 (en) | 2003-10-08 |
SI1494732T1 (sl) | 2008-08-31 |
US8783249B2 (en) | 2014-07-22 |
WO2003080149A2 (en) | 2003-10-02 |
US7140365B2 (en) | 2006-11-28 |
US20080041372A1 (en) | 2008-02-21 |
JP4681231B2 (ja) | 2011-05-11 |
CA2479751A1 (en) | 2003-10-02 |
US20140290654A1 (en) | 2014-10-02 |
EP1494732A4 (en) | 2005-05-11 |
US9700690B2 (en) | 2017-07-11 |
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