US 12,257,381 B2
System, cartridge and process
Andree Jung, Idar-Oberstein (DE); Stephen Terence Dunne, Oporto (PT); and Joachim Carl Herbert Eicher, Ingelheim am Rhein (DE)
Assigned to BOEHRINGER INGELHEIM INTERNATIONAL GMBH, Ingelheim am Rhein (DE)
Appl. No. 16/973,064
Filed by Boehringer Ingelheim International GmbH, Ingelheim am Rhein (DE)
PCT Filed Jun. 12, 2019, PCT No. PCT/EP2019/065344
§ 371(c)(1), (2) Date Dec. 8, 2020,
PCT Pub. No. WO2019/238749, PCT Pub. Date Dec. 19, 2019.
Claims priority of application No. 18177967 (EP), filed on Jun. 15, 2018.
Prior Publication US 2021/0268213 A1, Sep. 2, 2021
Int. Cl. A61M 15/00 (2006.01); A61M 5/24 (2006.01); A61M 11/00 (2006.01)
CPC A61M 15/0003 (2014.02) [A61M 5/2448 (2013.01); A61M 11/007 (2014.02); A61M 15/0065 (2013.01); A61M 2202/08 (2013.01)] 35 Claims
OG exemplary drawing
 
27. A method for preparing a fluid (2) which is a medicament produced from at least two components (2A, 2B) in a cartridge (3) which is completely inserted into at least one of a dispensing device and a nebulizer (1), such that after the insertion, at least one of the dispensing device and the nebulizer encloses the cartridge on all sides of the cartridge,
wherein the cartridge (3) comprises:
a seal (7),
a container (4) and a closure (6) for fluidic and/or sealing connection of the container (4) to the at least one of the dispensing device and the nebulizer,
wherein the cartridge (3) comprises at least two fluidically separated chambers (24, 25), each containing at least one of the at least two components (2A, 2B) of the fluid (2),
wherein the cartridge (3) comprises an actuating mechanism (31), with the at least two fluidically separated chambers (24, 25) being able to be fluidically connected to one another by actuating the actuating mechanism (31) in order to produce the fluid (2) by bringing the at least two components (2A, 2B) together,
wherein the cartridge (3) comprises two movable plungers (26, 27),
wherein the container (4) comprises or forms at least one fluid connection (30) operating to fluidically connect the at least two fluidically separated chambers (24, 25) to one another by permitting a transfer of the first component (2A) from the first chamber (24) into the second chamber (25),
wherein the actuating mechanism (31) comprises an actuating element (32), and the actuating mechanism (31) is actuated by: (i) removing the actuating element (32) from the container (4) or closure (6); and (ii) opening or separating the actuating element (32),
wherein the actuating mechanism (31) operates to secure the plungers (26, 27) against displacement in the cartridge (3) in a non-actuated state of the actuating mechanism (31),
wherein the plungers (26, 27) in the cartridge (3) or in the container (4) are releasable for displacement by actuating the actuating mechanism (31),
wherein the fluid connection (30) operates to open by displacing the first plunger (26) and the second plunger (27) in such a way that the at least two fluidically separated chambers (24, 25) are fluidically connected to one another via the at least one fluid connection (30), and
wherein the plungers (26, 27) in the cartridge (3) or in the container (4) are releasable by actuating the actuating mechanism (31) such that the plungers (26, 27) are displaced automatically in the cartridge (3) or in the container (4),
wherein the at least two fluidically separated chambers (24, 25) of the cartridge (3) which are initially fluidically separated from one another are fluidically connected to one another,
wherein at least one of the at least two components (2A, 2B) of the fluid (2) is at least partially transferred from one of the at least two fluidically separated chambers (24, 25) to another of the at least two fluidically separated chambers (24, 25) with a further one of the at least one of the at least two components (2A, 2B) of the fluid (2) in order to mix the at least two components (2A, 2B) and/or to produce the fluid (2),
wherein the actuating mechanism (31) is manually actuated in order to fluidically connect the at least two chambers (24, 25) to one another, and to mix the at least two components (2A, 2B) together,
wherein the cartridge (3) is only inserted into the at least one of the dispensing device and the nebulizer after the at least two components (2A, 2B) have been mixed, and is only thereafter opened in the at least one of the dispensing device and the nebulizer for a withdrawal of a dose of the fluid (2) only after the actuating element has been removed, and
wherein opening of the cartridge (3) is achieved by piercing, the seal (7).