ES2300568T3 - Aparato de inhalacion. - Google Patents
Aparato de inhalacion. Download PDFInfo
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- ES2300568T3 ES2300568T3 ES03716418T ES03716418T ES2300568T3 ES 2300568 T3 ES2300568 T3 ES 2300568T3 ES 03716418 T ES03716418 T ES 03716418T ES 03716418 T ES03716418 T ES 03716418T ES 2300568 T3 ES2300568 T3 ES 2300568T3
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- 230000000975 bioactive effect Effects 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- KYKAJFCTULSVSH-UHFFFAOYSA-N chloro(fluoro)methane Chemical compound F[C]Cl KYKAJFCTULSVSH-UHFFFAOYSA-N 0.000 description 1
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Classifications
-
- 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
-
- 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
-
- 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
-
- 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
-
- 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
-
- 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
-
- 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
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
- A61M2202/064—Powder
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Heart & Thoracic Surgery (AREA)
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- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Pulmonology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Confectionery (AREA)
- Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
- Respiratory Apparatuses And Protective Means (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Un aparato de inhalación (20) que comprende: una boquilla (26), incluyendo la boquilla (26) un ánima central (40) que tiene por lo menos un extremo abierto y un conducto (70) para llevar las partículas a la cavidad bucal del usuario; un cartucho (32) incluyendo por lo menos una porción (140) de recepción en el ánima (40), y una cámara (110) para guardar una sustancia inhalable; la boquilla (26) y el cartucho (32) estando en unión rotatoria el uno respecto al otro, y girable desde una primera posición, donde la cámara (110) se está cerrada al medio ambiente y al conducto (70), a una segunda posición, donde se ha abierto una senda de flujo desde el medio ambiente hasta el conducto (70) de la boquilla (26) a través de la cámara (110); y la boquilla (26) y el cartucho (32) incluyendo estructuras configuradas en cooperación (154, 90, 150) para retener la segunda posición una vez se ha alcanzado la segunda posición.
Description
Aparato de inhalación.
La presente invención está dirigida a
inhaladores, y en particular a inhaladores de polvo seco.
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.
Como resultado, 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 lo profundo 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 de atrás 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 ellas 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 EE.UU. nº 5.394.868 describe 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 de US 5.394.868 es
compleja, y no se presta en sí misma para un uso económico como un
artículo de dosis única.
El documento
WO-A-97/30743 describe una
configuración similar, en la cual se usan partes rotatorias para
cargar una cámara que está fijada a una boquilla.
Según un primer aspecto de la invención se
proporciona un aparato de inhalación según la Reivindicación 1.
En un segundo aspecto de la invención se
proporciona un método según la Reivindicación 8.
El aparato, componentes y métodos descritos en
la presente solicitud 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 descrito en la presente solicitud 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 descrito en la presente solicitud
puede usarse sin tener en cuenta la altitud y las condiciones
atmosféricas.
El inhalador descrito en la presente solicitud
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 una sola vez 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.
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 descrito en la presente solicitud 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 trasera 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 pieza 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 descrito en la presente solicitud; y
La Fig. 9 es una vista isométrica de la
realización de la Fig. 8, mostrando la extracción de la parte del
inhalador.
Las Figs. 1 y 2 muestran un aparato 20 formado
por una parte de inhalador (inhalador) 22 y una cubierta 24. La
parte del 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 rotatoria, permitiendo la
rotación del cartucho 32 con respecto a la boquilla 26, y viceversa
(de acuerdo con la flecha de doble dirección 41). Esta unión se
mantiene por las pestañas posicionadas correspondientemente 44
(Figs. 4 y 5A), 45 en la boquilla 26 y 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 el
usuario, a fin de girar el cartucho 32 en la boquilla 26.
La cubierta 24 generalmente se une a la parte
del 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 correspondientemente, extendiéndose
típicamente de forma continua alrededor de la superficie interior
53 (Fig. 4) de la cubierta 24. Las dimensiones de la caña 52 y
cubierta 24, ligadas al rebaje 54 y al/los saliente(s) 57
correspondientes, permite 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 para los dedos 58 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
típicamente diseñadas, donde la refijación de la cubierta 24 a la
boquilla 26 no es posible, 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. Alternativamente, 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 del inhalador 22
de la cubierta 24, o ambas la cubierta 24, o la boquilla 26
incluyen estructuras tipo trinquete en un solo sentido que dañan la
mencionada separación. Esto asegura que la sección del inhalador 22
será un dispositivo de uso único 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 del 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 del
inhalador 22) encima de la cual se extiende la cubierta 24. Esto
permite a la parte del inhalador 22 ser separada de la cubierta
simplemente fracturando/desprendiendo ésta o bien torciéndola o
girándola (en la dirección de la flecha de doble dirección 63), si
se emplea un sistema de enrosque mecánico (por ejemplo, una unión
de rosca tipo hélice) entre la parte del 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 del 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 dentro 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 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 conducto 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 conducto 70 incluye una abertura
72, típicamente una abertura redondeada o circular en su extremo
interior 73. Trasladándose al exterior, el conducto 70 tiene una
porción del diámetro constante 74, seguida por una porción
estrechada 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 del 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 optimizaron 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 conducto de entrada directo para la aceleración de
partículas/gas y el desarrollo de un campo de alto flujo de
cortante. Esta porción es típicamente 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 estrechada 76 se estrecha
exteriormente (hacia la abertura exterior 80), típicamente en
ángulos de aproximadamente 3 a 7 grados, y por ejemplo
aproximadamente de 4 grados para alcanzar, por ejemplo, una relación
de aspecto 2:1. En esta relación de aspecto, puede haber transición
de la velocidad de la corriente de la partícula que viaja en este
tubo 70. Esta porción estrechada 76 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 conducto 70. Esta
porción 78 tiene típicamente 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, típicamente un óvalo levantado u otra forma redondeada, funciona
como depresor de la lengua, así como el localizador del conducto de
descarga de la boquilla. Específicamente, como se muestra en detalle
en las Figs. 3C-3E, 4 y 7B, esta forma y 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 conducto 70, sirve como
superficie tope para el apoyo de los labios del usuario, permitiendo
a los labios formar un sello alrededor de la sección del tubo 28 en
este punto para la succión, a fin de reforzar la inhalación.
Alternativamente, 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 cabezal 102
(Figs. 6A-6C) del cartucho 32. Esta ánima 40 incluye
una hendidura dentada 90 (Figs. 4 y 7B) que permite a una llave
dimensionada correspondientemente 154 del cartucho 32 ser retenida
ahí, permitiendo mientras las rotaciones del cartucho 32 en la
boquilla 26 hasta 90 grados, a fin de que la parte del 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 transporte de partículas a los pulmones.
Los dientes (no mostrados), típicamente posicionados a 90 grados
unos de otros, se extienden dentro de la superficie 94 del ánima
interior 40. Estos dientes están configurados cooperativamente para
ajustar los bordes 150 en el cartucho 32, tras paso del cartucho 32
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.
Alternativamente, 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 uso único 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 cabezal 102 y una porción caudal 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 cabezal 102 y caudal 104 cuando se juntan alojan una
cámara 110 en su interior combinado.
Una canalización de entrada 112, para la toma
del aire se extiende dentro de la cámara 110, en la porción cabezal
102. Esta canalización de entrada 112 está formada por un canal de
alimentación 114, correspondientemente formado con respecto al
puerto 60, para la alineación cuando la parte del 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 conducto de salida 118 para las partículas se
extiende desde la cámara 110 (a través de las aberturas 119) hasta
la superficie exterior 120 del cartucho 32. Este conducto 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 del inhalador 22 estando en la posición abierta (Fig.
7).
Dentro de la cámara 110, están los bordes 130a,
130b, típicamente de forma redondeada. En la porción caudal 104, los
bordes 130b se extienden para formar un saliente central 132. Este
saliente 132 tiene típicamente 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 conducto 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 típicamente en forma de polvo seco. Este
inhalante puede ser por ejemplo molécula(s)
bioactiva(s) encapsuladas en partículas Technosphere® de la
Corporación Mannkind, Valencia, California, 91355, como se describe
en el documento de US 2004/018152, o atropina, antibióticos, como la
penicilina doxiciclina, ciprofloxacina y fluoroquinolonas,
encapsuladas en partículas Technosphere®, estas partículas
Technosphere® y los métodos para su fabricación se describen en las
Patentes de EE.UU. Nos. 5.352.461, 5.503.852 y 6.071.497.
La porción cabezal 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 del disco 144, encima de la porción cónica 142. Las pestañas
45 se extienden típicamente 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 típicamente rectangular para lograr el
control óptimo del flujo, así como la abertura 122 para el conducto
de salida 118.
Los bordes 150, sobresalen una ligera distancia
de la superficie 151 de la porción cónica 142. Extendiendo esta
ligera distancia, unida al material del cartucho, y por tanto el
borde 150, los bordes 150 se comportan en una forma parecida a un
resorte. Los bordes 150 son típicamente de puntas cuadradas o
afiladas 152, pero también podrían ser radiales o redondeados en
sus bordes. Los bordes 150 están correspondientemente dimensionados
para 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 típicamente 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 posicionan típicamente 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 del
disco 144. La llave 154 tiene típicamente 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 caudal 104 incluye la sección del
cuello acanalada 49, como se detalló anteriormente. Adicionalmente,
están las roscas 158 o dientes del anillo al final de la porción
caudal 104, que se pueden unir con las correspondientes roscas 159
o bordes en la cubierta 24, para mantener la cubierta en la sección
del inhalador 22. Alternativamente, esta sección de la porción
caudal 104 y la porción correspondiente de la cubierta 24 pueden
proveerse de un bloqueo permanentemente una vez unidas, promoviendo
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 caudal 104 es opcional, ya que el funcionamiento normal de
la parte del inhalador 22 no requiere que la cubierta 24 se una a
la porción caudal 104.
Todos los componentes mencionados, la cubierta
24, la boquilla 26 y el cartucho 28, y todas las estructuras encima
y/o dentro están típicamente 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 la presente solicitud. Estos plásticos,
polímeros y otros materiales pueden seleccionarse, por ejemplo, en
base a la composición que estará en la cámara 110, a los factores
medioambientales y de almacenamiento y similares. Estos componentes
se forman típicamente por técnicas como el moldeo y por ejemplo, el
moldeo por inyección.
Volviendo específicamente a las Figs. 7A y 7B,
está detallada la parte del 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 conducto de
salida 118 se posicionan en el cartucho 32, que habiendo sido
girados, están alineados respectivamente con el puerto de entrada 60
y el conducto de descarga 70. Esta alineación en la posición
abierta, crea una senda de flujo para la inhalación, desde la
abertura de entrada 62 (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 conducto de descarga 70 de la boquilla 26, donde el flujo
de partículas se inhala para la entrega final a los pulmones,
incluso a la profundidad de los pulmones. El puerto de entrada 60,
unido al canal de alimentación 114, y el conducto de salida 118,
están típicamente angulados a un ángulo \theta, 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 senda del flujo.
Las Figs. 8 y 9 muestran un sistema unitario
múltiple 200. Aquí, las partes únicas del inhalador 222, similares
en todos los aspectos a las partes del 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 individuales 20'.
\vskip1.000000\baselineskip
Este listado de referencias citadas por el
solicitante tiene como único fin la conveniencia del lector. No
forma parte del documento de la Patente Europea. Aunque se ha puesto
gran cuidado en la compilación de las referencias, no pueden
excluirse errores u omisiones y la OEP rechaza cualquier
responsabilidad en este sentido.
- \bullet US 5394868 A
- \bullet US 5352461 A
- \bullet WO 9730743 A
- \bullet US 2004018152 A
- \bullet US 5503852 A
- \bullet US 6071497 A
Claims (9)
1. Un aparato de inhalación (20) que
comprende:
una boquilla (26), incluyendo la boquilla (26)
un ánima central (40) que tiene por lo menos un extremo abierto y un
conducto (70) para llevar las partículas a la cavidad bucal del
usuario;
un cartucho (32) incluyendo por lo menos una
porción (140) de recepción en el ánima (40), y una cámara (110) para
guardar una sustancia inhalable;
la boquilla (26) y el cartucho (32) estando en
unión rotatoria el uno respecto al otro, y girable desde una primera
posición, donde la cámara (110) se está cerrada al medio ambiente y
al conducto (70), a una segunda posición, donde se ha abierto una
senda de flujo desde el medio ambiente hasta el conducto (70) de la
boquilla (26) a través de la cámara (110);
y
la boquilla (26) y el cartucho (32) incluyendo
estructuras configuradas en cooperación (154, 90, 150) para retener
la segunda posición una vez se ha alcanzado la segunda posición.
2. El aparato de la Reivindicación 1, que
comprende adicionalmente una cubierta (24), la cubierta (24) estando
adaptada para cubrir la boquilla (26).
3. El aparato de la Reivindicación 2, en donde
la cubierta (24) y el cartucho (32) incluyen estructuras
configuradas en cooperación (54, 57) para retener la cubierta (26)
en un engranaje con el cartucho (32), una vez que se haya colocado
la cubierta sobre el cartucho.
4. El aparato de cualquier reivindicación
precedente, en donde el aparato es un aparato de dosificación
única.
5. El aparato de la Reivindicación 1, en donde
el cartucho (32) comprende un conducto de colimación (116).
6. El aparato de la Reivindicación 5, en donde
el conducto de colimación (116) en uso dirige el flujo de aire
hacia un saliente (132) en la cámara (110).
7. El aparato de la Reivindicación 5 o
Reivindicación 6 que incluye además por lo menos un saliente (132) y
dos o más bordes (130a y 130b) que junto con el conducto de
colimación (116) en uso crean vórtices cuando el aparato está en la
segunda posición.
8. Un método de preparar un aparato de
inhalación, que comprende:
- proporcionar una sustancia inhalable en una cámara (110) de un aparato de inhalación (20) que comprende:
- una boquilla (26), incluyendo la boquilla (26) un ánima central (40) que tiene por lo menos un extremo abierto y un conducto (70) para llevar las partículas a la cavidad bucal del usuario;
- un cartucho (32) incluyendo por lo menos una porción (140, 152) para la recepción en el ánima (40), y una cámara (110) para guardar una sustancia inhalable;
- la boquilla (26) y el cartucho (32) estando en unión rotatoria uno con respecto a otro, y rotatoria desde una primera posición, donde la cámara (110) está cerrada al medio ambiente y al conducto (70), a una segunda posición, donde se ha abierto una senda de flujo desde el medio ambiente al conducto (70) de la boquilla (26) a través de la cámara (110);
- la boquilla (26) y el cartucho (32) incluyendo estructuras configuradas en cooperación (154, 90, 150) para retener la segunda posición una vez que se ha alcanzado la segunda posición; y
- el método incluyendo el paso de:
- girar el cartucho (32) con respecto a la boquilla (26) desde la primera posición a la segunda posición para abrir la senda de flujo.
9. El método de la Reivindicación 8,
comprendiendo adicionalmente el cierre del cartucho (32) con
respecto a la boquilla (26) en la segunda posición.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US36630202P | 2002-03-20 | 2002-03-20 | |
| US366302P | 2002-03-20 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2300568T3 true ES2300568T3 (es) | 2008-06-16 |
Family
ID=28454776
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES07022752T Expired - Lifetime ES2425392T3 (es) | 2002-03-20 | 2003-03-07 | Cartucho para un aparato de inhalación |
| ES03716418T Expired - Lifetime ES2300568T3 (es) | 2002-03-20 | 2003-03-07 | Aparato de inhalacion. |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES07022752T Expired - Lifetime ES2425392T3 (es) | 2002-03-20 | 2003-03-07 | Cartucho para un aparato de inhalación |
Country Status (12)
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|---|---|
| US (5) | US6923175B2 (es) |
| EP (2) | EP1894591B1 (es) |
| JP (1) | JP4681231B2 (es) |
| AT (1) | ATE385193T1 (es) |
| AU (1) | AU2003220125B2 (es) |
| CA (1) | CA2479751C (es) |
| CY (1) | CY1108072T1 (es) |
| DE (1) | DE60318938T2 (es) |
| ES (2) | ES2425392T3 (es) |
| PT (1) | PT1494732E (es) |
| SI (1) | SI1494732T1 (es) |
| WO (1) | WO2003080149A2 (es) |
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2003
- 2003-03-07 WO PCT/US2003/007231 patent/WO2003080149A2/en not_active Ceased
- 2003-03-07 AT AT03716418T patent/ATE385193T1/de active
- 2003-03-07 ES ES07022752T patent/ES2425392T3/es not_active Expired - Lifetime
- 2003-03-07 EP EP07022752.5A patent/EP1894591B1/en not_active Expired - Lifetime
- 2003-03-07 DE DE60318938T patent/DE60318938T2/de not_active Expired - Lifetime
- 2003-03-07 SI SI200331198T patent/SI1494732T1/sl unknown
- 2003-03-07 US US10/384,909 patent/US6923175B2/en not_active Expired - Lifetime
- 2003-03-07 AU AU2003220125A patent/AU2003220125B2/en not_active Ceased
- 2003-03-07 CA CA002479751A patent/CA2479751C/en not_active Expired - Fee Related
- 2003-03-07 PT PT03716418T patent/PT1494732E/pt unknown
- 2003-03-07 EP EP03716418A patent/EP1494732B1/en not_active Expired - Lifetime
- 2003-03-07 ES ES03716418T patent/ES2300568T3/es not_active Expired - Lifetime
- 2003-03-07 JP JP2003577973A patent/JP4681231B2/ja not_active Expired - Fee Related
-
2005
- 2005-04-29 US US11/118,853 patent/US7140365B2/en not_active Expired - Lifetime
-
2006
- 2006-10-05 US US11/539,082 patent/US8166970B2/en active Active
-
2008
- 2008-02-13 CY CY20081100162T patent/CY1108072T1/el unknown
-
2012
- 2012-04-02 US US13/437,840 patent/US8783249B2/en not_active Expired - Lifetime
-
2014
- 2014-06-12 US US14/303,173 patent/US9700690B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| EP1494732A4 (en) | 2005-05-11 |
| US20140290654A1 (en) | 2014-10-02 |
| CA2479751A1 (en) | 2003-10-02 |
| DE60318938T2 (de) | 2009-01-22 |
| JP2005520641A (ja) | 2005-07-14 |
| EP1894591B1 (en) | 2013-06-26 |
| US8166970B2 (en) | 2012-05-01 |
| CA2479751C (en) | 2008-06-03 |
| CY1108072T1 (el) | 2014-02-12 |
| EP1494732A2 (en) | 2005-01-12 |
| US7140365B2 (en) | 2006-11-28 |
| US20050188988A1 (en) | 2005-09-01 |
| EP1494732B1 (en) | 2008-01-30 |
| EP1894591A3 (en) | 2008-10-29 |
| AU2003220125B2 (en) | 2006-06-15 |
| EP1894591A2 (en) | 2008-03-05 |
| ES2425392T3 (es) | 2013-10-15 |
| US6923175B2 (en) | 2005-08-02 |
| US20080041372A1 (en) | 2008-02-21 |
| US20120247464A1 (en) | 2012-10-04 |
| AU2003220125A1 (en) | 2003-10-08 |
| US20030209245A1 (en) | 2003-11-13 |
| US8783249B2 (en) | 2014-07-22 |
| PT1494732E (pt) | 2008-03-20 |
| DE60318938D1 (de) | 2008-03-20 |
| WO2003080149A2 (en) | 2003-10-02 |
| JP4681231B2 (ja) | 2011-05-11 |
| US9700690B2 (en) | 2017-07-11 |
| WO2003080149A3 (en) | 2004-02-05 |
| ATE385193T1 (de) | 2008-02-15 |
| SI1494732T1 (sl) | 2008-08-31 |
| HK1116106A1 (en) | 2008-12-19 |
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