Stopper device, medicament container, and method for mixing two substances in a medicament container
A stopper device (1) seals off a medicament container (45) with a stopper element (3), wherein the stopper device is designed to seal the medicament container (45) in an axial direction of a center axis (M) of the medicament container (45), wherein the stopper device (1) is at least partially insertable into the medicament container (45), and the stopper element (3), in the intended installation position in the medicament container (45), is displaceable along the center axis (M) of the medicament container (45). The stopper device (1) has a retention region (23) with at least one retention means (5), wherein a closure element (7), in a first functional state of the stopper device (1), is retained by the retention means (5) in a fixed position relative to the stopper element (3), in particular retained releasably in a retention position on the stopper element (3), in such a way that a cavity (29) is formed between the closure element (7) and the stopper element (3).
1. A stopper device ( 1 ) for sealing off a medicament container ( 45 ) with a stopper element ( 3 ),
wherein the stopper device ( 1 ) is embodied to seal off the medicament container ( 45 ) in an axial direction of a center axis (M) of the medicament container ( 45 ),
wherein the stopper device ( 1 ) is at least partially insertable into the medicament container ( 45 ) and in an intended installation position in the medicament container ( 45 ) the stopper element ( 3 ) is displaceable along the center axis (M) of the medicament container ( 45 ),
wherein the stopper device ( 1 ) has a retention region ( 23 ) with at least one retention means ( 5 ),
wherein, in a first functional state of the stopper device ( 1 ), a closure element ( 7 ) is releasably retained in a fixed position relative to the stopper element ( 3 ) by means of the retention means ( 5 ), in such a way that a cavity ( 29 ) is formed between the closure element ( 7 ) and the stopper element ( 3 ), and
wherein the closure element ( 7 ) has at least one first locking means,
wherein the retention means ( 23 ) of the stopper device ( 1 ) has at least one second locking means embodied corresponding to the first locking means and arranged in the retention region ( 23 ) on a side of the stopper element ( 3 ) facing the closure element ( 7 ), and
wherein, in the first functional state, the first locking means and the second locking means engage in one another in a locking manner.
2. The stopper device ( 1 ) according to claim 1 , characterized in that in a second functional state the cavity ( 29 ) is open, wherein the closure element ( 7 ) is not retained in a retention position by the retention means ( 5 ).
3. The stopper device ( 1 ) according to claim 1 , characterized in that the closure element ( 7 ), in a second functional state, is arranged freely movable in the medicament container ( 45 ).
4. The stopper device ( 1 ) according to claim 1 , characterized in that, in the first functional state, the stopper element ( 3 ) has a discharge projection ( 63 ) on a side of the discharge projection ( 63 ) facing the closure element ( 7 ) and the discharge projection ( 63 ) is at least partially oriented in a direction of the closure element ( 7 ).
5. The stopper device ( 1 ) according to claim 4 , characterized in that, at least in an ejection state of the stopper device ( 1 ), the discharge projection ( 63 ), with a side and/or tip facing the closure element ( 7 ), is positioned against the closure element ( 7 ).
6. The stopper device ( 1 ) according to claim 1 , characterized in that the stopper device ( 1 ) has an insertion sleeve ( 15 ) enveloping the stopper element ( 3 ), wherein an outer side of a sleeve wall is contacted against an inner wall ( 53 ) of the medicament container ( 45 ).
7. The stopper device ( 1 ) according to claim 6 , characterized in that the insertion sleeve ( 15 ) is designed as a finger rest and has at least one radially protruding finger plate ( 19 ) at a proximal end, which finger plate ( 19 ) is grasped from behind by a finger.
8. The stopper device ( 1 ) according to claim 7 , characterized in that the insertion sleeve ( 15 ) has a fastening structure ( 41 ) for fastening the insertion sleeve ( 15 ) to the medicament container ( 45 ), wherein the fastening structure ( 41 ) has a receptacle ( 43 ) for the medicament container ( 45 ), in which receptacle ( 43 ) the proximal end ( 49 ) of the medicament container ( 45 ) is received in a locking and/or clamping manner.
9. A medicament container, comprising a base body ( 47 ) and a stopper device ( 1 ) for sealing off the medicament container ( 45 ) with a stopper element ( 3 ),
wherein the stopper device ( 1 ) is embodied to seal off the medicament container ( 45 ) in an axial direction of a center axis (M) of the medicament container ( 45 ),
wherein the stopper device ( 1 ) is at least partially insertable into the medicament container ( 45 ) and in an intended installation position in the medicament container ( 45 ) the stopper element ( 3 ) is displaceable along the center axis (M) of the medicament container ( 45 ),
wherein the stopper device ( 1 ) has a retention region ( 23 ) with at least one retention means ( 5 ),
wherein, in a first functional state of the stopper device ( 1 ), a closure element ( 7 ) is releasably retained in a fixed position relative to the stopper element ( 3 ) by means of the retention means ( 5 ), in such a way that a cavity ( 29 ) is formed between the closure element ( 7 ) and the stopper element ( 3 ),
wherein the stopper device ( 1 ) is arranged moved into the medicament container ( 45 ) such that the stopper element ( 3 ) seals off a proximal end ( 49 ) of the medicament container ( 45 ) with respect to a chamber ( 51 ) of the base body ( 47 ),
wherein the chamber ( 51 ) is delimited in a radial direction by the inner wall ( 53 ) of the base body ( 47 ) and in a distal direction by an outlet opening ( 55 ) of the base body ( 47 ) and/or a closure cap ( 57 ), and
wherein the stopper element ( 3 ) is elastic,
wherein it is deformable by means of the projection ( 73 ) of the dispensing device ( 67 ), and
wherein the discharge projection ( 63 ) of the stopper element ( 3 ) has a greater strength in the axial direction than the pressure required to move the closure element ( 7 ).
10. The medicament container according to claim 9 , characterized in that the outlet opening ( 55 ) of the base body ( 47 ) has a geometry at least on a side of the outlet opening facing the chamber ( 51 ), which differs from a side of the closure element ( 7 ) facing the outlet opening such that a fluidically tight closure of the outlet opening ( 55 ) is prevented by the closure element ( 7 ).
11. The medicament container according to claim 9 , characterized by a dispensing device ( 67 ), wherein a projection ( 73 ) is provided at a distal end ( 71 ) of the dispensing device ( 67 ).
12. A method for mixing two substances ( 31 , 59 ) stored separately from one another in terms of flow in the medicament container ( 45 ) according to claim 9 , wherein a first substance ( 31 ) of the two substances ( 31 , 59 ) is arranged in the cavity ( 29 ) of the stopper device ( 1 ) and a second substance ( 59 ) of the two substances ( 31 , 59 ) is arranged in the chamber ( 51 ) of the base body ( 47 ), wherein the stopper element ( 3 ) is acted upon with a force in the distal direction, wherein the fluidic separation of the two substances ( 31 , 59 ) is eliminated, characterized in that the stopper device ( 1 ), is deformed, at least partially, due to the distal force application, such that the closure element ( 7 ) is moved out of a retention position.
13. A method for mixing two substances ( 31 , 59 ) stored separately from one another in terms of flow in a medicament container ( 45 ), the medicament container ( 45 ) with a base body ( 47 ) and a stopper device ( 1 ) for sealing off a medicament container ( 45 ), with a stopper element ( 3 ),
wherein the stopper device ( 1 ) is embodied to seal off the medicament container ( 45 ) in an axial direction of a center axis (M) of the medicament container ( 45 ),
wherein the stopper device ( 1 ) is at least partially insertable into the medicament container ( 45 ) and in an intended installation position in the medicament container ( 45 ) the stopper element ( 3 ) is displaceable along the center axis (M) of the medicament container ( 45 ),
wherein the stopper device ( 1 ) has a retention region ( 23 ) with at least one retention means ( 5 ),
wherein, in a first functional state of the stopper device ( 1 ), a closure element ( 7 ) is releasably retained in a fixed position relative to the stopper element ( 3 ) by means of the retention means ( 5 ), in such a way that a cavity ( 29 ) is formed between the closure element ( 7 ) and the stopper element ( 3 ),
wherein the stopper device ( 1 ) is arranged moved into the medicament container ( 45 ) such that the stopper element ( 3 ) seals off a proximal end ( 49 ) of the medicament container ( 45 ) with respect to a chamber ( 51 ) of the base body ( 47 ),
wherein the chamber ( 51 ) is delimited in a radial direction by the inner wall ( 53 ) of the base body ( 47 ) and in a distal direction by an outlet opening ( 55 ) of the base body ( 47 ) and/or a closure cap ( 57 ),
wherein a first substance ( 31 ) of the two substances ( 31 , 59 ) is arranged in the cavity ( 29 ) of the stopper device ( 1 ) and a second substance ( 59 ) of the two substances ( 31 , 59 ) is arranged in the chamber ( 51 ) of the base body ( 47 ),
wherein the stopper element ( 3 ) is acted upon with a force in the distal direction, wherein the fluidic separation of the two substances ( 31 , 59 ) is eliminated, characterized in that the stopper device ( 1 ), is deformed, at least partially, due to the distal force application, such that the closure element ( 7 ) is moved out of a retention position,
wherein the stopper element ( 3 ) is displaced in the distal direction,
wherein the fluidic separation of the two substances ( 31 , 59 ) is eliminated,
wherein the retention region ( 23 ) relaxes radially during a distal displacement of the stopper device ( 1 ), and
wherein a retention of the closure element ( 7 ) in the retention position is released.
14. The method according to claim 13 , characterized in that the medicament container ( 45 ) is shaken after the cavity ( 29 ) has been opened.
15. The method according to claim 13 , characterized in that the stopper device ( 1 ) is displaced into an end position for a complete discharge of the two substances ( 31 , 59 ) in the medicament container ( 45 ), wherein the closure element ( 7 ) is received in the end position in the cavity ( 29 ), and wherein the cavity ( 29 ) is completely filled by the closure element ( 7 ).