Closure cap for a medical container and method for assembly thereof

Abstract

The invention relates to a closure cap for a container filled with a medical liquid. The closure cap has at least one connection with a scaling element which can be pierced by a spike or a needle to remove the medical fluid. A flap is arranged on an inner side of the closure cap and is connected to the main body by means of a hinge. The sealing element is fixed to the closure cap by the flap folded against the main body.

Claims

1. A closure cap for a container filled with a medical liquid, the closure cap comprising: a base body and at least one connection with a sealing element which can be pierced with a spike or a needle to remove the medical liquid, and a flap arranged inside on an underside of the base body of the closure cap and connected to the base body by a hinge, the sealing element being fixed to the closure cap by the flap folded against the base body.

2. The closure cap according to claim 1, wherein the sealing element is closed with a tamper-evident closure, in particular is covered with a break-off piece which is connected to the base body of the closure cap via a predetermined breaking point surrounding the sealing element.

3. The closure cap according to claim 1, wherein the sealing element has a circumferential ring which sits in a groove of the base body and/or the flap.

4. The closure cap according to claim 1, wherein the flap folded against the base body is latched to the base body.

5. The closure cap according to claim 1, wherein the flap is designed as a plate with at least one opening in which a piercing region of the sealing element is located.

6. The closure cap according to claim 1, wherein the hinge is designed as a film hinge.

7. The closure cap according to claim 1, wherein the closure cap has at least two connections, each with a sealing element.

8. The closure cap according to claim 7, wherein the flap is designed as a single flap which fixes the sealing elements of the at least two connections to the closure cap.

9. The closure cap according to claim 1, wherein the hinge is arranged on a long side of the flap, wherein the flap is latched to the base body on an opposite long side.

10. The closure cap according to claim 9, wherein a latching body of the base body engages around a corner of the opposite long side of the flap.

11. The closure cap according to claim 10, wherein the corner is rounded.

12. The closure cap according to claim 1, wherein the base body and the flap are part of a one-piece plastic injection-molded part.

13. The closure cap according to claim 7, where the closure cap has exactly two connections, each with a sealing element.

14. A container filled with a medical liquid comprising a closure cap according to claim 1.

15. The container according to claim 13, wherein the container comprises a bottle produced using a Blow-Fill-Seal (BFS) or a Strech-Blow-Molding (SBM) process.

16. The container according to claim 15, wherein the container is sterilized.

17. A method for assembling a closure flap for a container filled with a medical liquid, in particular for the container according to claim 14, comprising the steps: providing a closure cap which has a base body with at least one opening for a connection, wherein the closure cap has inside on an underside of the base body a flap with at least one opening which can be folded relative to the base body; inserting a sealing element inside in front of the opening of the base body or in front of the opening of the flap; and folding the flap onto the base body, wherein the flap is fixed in an end position on the base body and the sealing element is fixed between the opening of the base body and the opening of the flap.

18. The method according to claim 17, wherein the sealing element is inserted into the opening of the base body or the flap in such manner that it is held centred centered and securely in position.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The invention will be explained in more detail below with reference to an exemplary embodiment of the invention on the basis of the drawings FIG. 1 to FIG. 19.

(2) FIG. 1 is a perspective view of an exemplary embodiment of a closure cap according to the invention.

(3) FIG. 2 is a side view.

(4) FIG. 3 is a perspective view from below showing the inner side.

(5) FIG. 4 is a plan view of the underside.

(6) FIG. 5 is a plan view of the upper side.

(7) FIG. 6 is a longitudinal section of the closure cap.

(8) FIG. 7 is a plan view of the sealing element.

(9) FIG. 8 is a cross-section of the sealing element.

(10) FIG. 9 is a longitudinal section of the closure cap centred along the connections.

(11) FIG. 10 is a detailed view of the region A of FIG. 9.

(12) FIG. 11 is a side view and FIG. 12 is a sectional view along the line A-A of FIG. 11.

(13) FIG. 13 is a detailed view of the region A of FIG. 12.

(14) FIG. 14 is a side view and FIG. 15 is a longitudinal section along the line A-A of FIG. 14.

(15) FIG. 16 is a plan view of the underside and FIG. 17 is a longitudinal section along the line A-A of FIG. 16.

(16) FIG. 18 is a schematic view of a container provided with the closure cap.

(17) FIG. 19 shows the steps of a method according to the invention for assembling a closure cap according to an exemplary embodiment of the invention.

DETAILED DESCRIPTION OF THE DRAWINGS

(18) FIG. 1 is a perspective view of a closure cap 1 according to an exemplary embodiment of the invention.

(19) The closure cap 1 is designed to be pot-shaped and comprises a base body 20 with a connection flange 21 for connection to the head region of a medical container. The base body 20 is formed by the bottom 20a and the side wall 20b. The side wall 20b extends over the circumference of the bottom 20a. The bottom 20a provides the underside of the base body 20. Since the closure cap 1 is fitted with its open side onto the head part 3 of a container 2 (see, for example, FIG. 18), the bottom 20a, in the fitted state, provides the upper end, so to speak the lid of the closure cap 1.

(20) On its upper side, the closure cap 1 in this exemplary embodiment comprises two connections 10a, 10b.

(21) The connections 10a, 10b each comprise a connection nozzle 22a, 22b, which is a part of the base body 20 in the sense of the terminology of the present invention.

(22) A sealing element 40 is arranged within each of the connection nozzles 22a, 22b, the piercing region 41 of which is covered by a break-off piece 11a, 11b. The break-off pieces 11a, 11b each comprise a radially outwardly projecting wing grip 12a, 12b. The wing grips 12a, 12b form a lever which facilitates the removal of the break-off pieces 11a, 11b.

(23) As represented in the side view according to FIG. 2, the connection nozzles 22a, 22b merge into one another in this exemplary embodiment. This ensures a particularly space-saving arrangement.

(24) The break-off pieces 11a, 11b are connected to the base body 20 or the connection nozzles 22a, 22b via predetermined breaking points 13a, 13b. The predetermined breaking points 13a, 13b are designed as weakening zones in which the wall thickness of the break-off pieces 11a, 11b is reduced in order to facilitate breaking off.

(25) In the two wing grips 12a and 12b an arrow is provided which identifies the connection nozzle as a connection for supply or removal. The arrow in the wing grip 12a marks the connection nozzle 22a as a connection for supplying a liquid, for example a medication, into the container 2. The arrow in the wing grip 12b, on the other hand, marks the connection nozzle 22b as a connection for removing the medical liquid from the container 2. The arrows are inserted here as recesses in the wing grips.

(26) FIG. 3 shows a perspective view of the underside or inner side of the closure cap 1. The unassembled state without sealing elements 40 is represented.

(27) In this exemplary embodiment, the connection flange 21 comprises a circumferential groove 23, which can be fitted on the head part 3 of a container 2 and thus welded or glued to the head part 3.

(28) A flap 30 is arranged on the inner side on the underside of the base body 20. In detail, the flap 30 is arranged on the inner side of the bottom 20a of the base body 20. In the unassembled state, the flap 30 can be positioned approximately at a right angle to the underside of the base body 20.

(29) The flap 30 is plate-shaped and comprises two openings 32a, 32b, which, in the assembled state, overlap with the piercing region 41 of the sealing element 40.

(30) The openings 32a, 32b are surrounded by an annular web 31a, 31b, which, in the assembled state, serves as a form-fitting element for the sealing element 40, in that the web 31a, 31b rests against a ring 44 of the sealing element 40. The flap 30 can be folded against the underside of the base body 20 via a film hinge 35.

(31) FIG. 4 shows the closure cap 1 in a plan view of the underside or inner side. The connection nozzles 22a, 22b of the base body also comprise openings 24a, 24b, which, in the assembled state, overlap with the piercing region 41 of the sealing element 40 and with the openings 31a, 31b of the flap 30.

(32) FIG. 4 also shows the non-assembled state in which the flap 30 is folded downwards. The flap 30 comprises a long side and a narrow side.

(33) On the opposite side of the film hinge 35, a latching element 25 is arranged on the underside of the base body opposite the long side of the flap 30.

(34) Furthermore, two edge-side latching elements 26 run concentrically around the openings 24a, 24b, which, in the assembled state, enclose the edges of the flap 30 opposite the film hinge 35.

(35) To assemble the closure cap, the sealing elements 40 (see FIG. 7, FIG. 8) can be inserted into the openings 24a, 24b and then the flap 30 is closed and latched in the assembled state.

(36) As represented in FIG. 3, the openings 32a, 32b are surrounded by an annular web 31a, 31b, which serves as a form-fitting element for a groove 42 of the sealing element 40.

(37) FIG. 5 is a plan view of the upper side of the closure cap. The wing grips 12a, 12b for breaking off the break-off pieces 11a, 11b extend approximately to the outer edge of the closure cap 1 in the plan view from above (above in the sense of the terminology are the connections 10a, 10b, even if, for example, when using the container 2 for infusion, the connections are arranged at the bottom, i.e. the container 2 is used upside down).

(38) FIG. 6 is a longitudinal section of the closure cap, which runs centrally through the connections 10a, 10b. The section is directed at the downwardly folded flap 30, which does not protrude beyond the underside of the closure cap 1 and extends to the connection flange 21. The flap 30 is designed to be plate-shaped.

(39) In the assembled state, the openings 32a, 32b run concentrically to the openings 24a, 24b of the base body 20 or the nozzles 22a, 22b, in each of which a sealing element 40 sits in the assembled state.

(40) An annular web 28a, 28b extends around the openings 24a, 24b, through which an annular groove 27a, 27b is formed, which extends axially and in which a ring 43 or annular web of the sealing element 40 sits in the assembled state. Furthermore, a chamfer 33 extends at least around the side opposite the film hinge 35 and the narrow sides on the edge of the flap 30, which forms a ramp for pushing away the latching elements 25, 26 when the flap 30 latches when it is closed.

(41) The connection nozzles 22a, 22b merge into one another such that a wall in the form of the web 28 is formed between the connection nozzles 22a, 22b. Starting from this common web 28, the walls of the connection nozzles 22a, 22b diverge such that in the plan view from above they each form rings which overlap in the region of the web (see FIG. 5).

(42) FIG. 7 shows a sealing element in a plan view from above. This is designed to be circular and consists of an elastic material, such as for example polyisoprene.

(43) The sealing element 40 comprises a piercing region 41 into which a spike (not represented) can be inserted in this exemplary embodiment. The piercing region 41 is provided with a ring-shaped marking 45. The piercing region 41 is slotted in a cross shape via the slots 46, 47. Such slotted sealing elements are used in particular to connect a spike for removing the liquid. These are also commonly referred to as stoppers.

(44) In particular, for an inlet port through which, for example, a pharmaceutically active ingredient can be filled into the container 2, non-slotted sealing elements are generally used. These are also commonly referred to as septum (not represented). These can also have a different geometry (not represented).

(45) An annular groove 42 runs around the piercing region 41, to which an annular web 43 is connected radially outwards, which serves as a form-fitting element.

(46) FIG. 8 is a central longitudinal section of the sealing element 40. Since the section runs exactly through a slot 47, the material of the piercing region 41, from which the marking 45 protrudes on the upper side, is not hatched in this representation. The slots 46, 47 do not run to the underside of the sealing element 40, but end before it. When a spike is inserted into the sealing element 40 for the first time, the sealing element tears open below the slots 46, 47. However, the sealing element 40 closes again when the spike is pulled out due to the elasticity of the material.

(47) On the edge side, the sealing element 40 comprises a circumferential ring 43, 44 or an annular web on both its upper side and its lower side, which serves as a form-fitting element.

(48) FIG. 9 is a longitudinal section of the closure cap 1 in the assembled state, which runs centrally through the connections 10a, 10b. In this embodiment, two identical sealing elements 40 are used. Two different sealing elements 40 can also be used (not represented).

(49) FIG. 10 is a detailed view of the region A of FIG. 9, in which the region of one of the sealing elements 40 is represented. The sealing element 40 is now located between the flap 30 and the underside of the closure cap 1. The flap 30 rests on the underside of the base body 20. The upper ring 43 of the sealing element 40 sits in the annular groove 27b of the connection nozzle 22b. This creates a form-fitting connection.

(50) On the underside, the ring 44 of the sealing element 40 sits between the annular web 31b of the flap and the bottom 20a and the side wall 20b of the base body 20 or the connection nozzle 22b.

(51) Adjacent to the opposite connection nozzle 22a, the ring 44 sits between the web 28, which lies between the connection nozzles 22a, 22b and which, according to the annular groove in which the ring 44 sits, merges into the side walls starting from the point represented here where the side walls of the connection nozzles 22a, 22b overlap. The web 28 or the side walls of the connection nozzles 22a, 22b extend downwards to the flap 30. The ring 44 is thus located in a groove which is formed by the flap 30 and the opposite base body 20 or the connection nozzle 22b.

(52) The predetermined breaking point 31b is located approximately at the height of the upper side of the piercing region 41 of the sealing element 40, from which the marking 45 can protrude. After breaking off the break-off piece 10b, the piercing region 41 is easily accessible, in particular for disinfection by wiping.

(53) FIG. 11 is a side view of the closure cap and FIG. 12 is a longitudinal section along the line A-A of FIG. 11. FIG. 12 shows the flap 30 in the unassembled state, which comprises the chamfer 33 on one long side. The chamfer 33 can in particular be designed as a 30-60 chamfer.

(54) The latching element 25 is located on the long side of the flap 30 opposite the film hinge 35. As represented in the detailed view of the region A of FIG. 12 according to FIG. 13, the latching element 25 is designed to be hook-shaped. This comprises a hook 25a which, starting from the downwardly extending wall of the latching element 25, is directed radially inwards. The hook 25a comprises an inclined surface 25c on the front side, past which the chamfer 33 of the flap 30 slides when latching and thus pushes the latching element 25 to the side in a resilient manner. The inclined surface can run at an angle of 30 to 60 to a surface oriented perpendicular to the central axis of the closure cap 1.

(55) As soon as the flap 30 has reached its end position, the latching element 25 springs back and the contact surface 25b lies, preferably parallel to the flap 30, under the flap 30, such that the flap 30 is now fixed by the latching element 25.

(56) In the unassembled state, the film hinge 35 extends downwards starting from a base 34. In the assembled state, the base 34 limits the groove in which the ring 43 of the sealing element 40 sits. The film hinge 35 is formed by a region which is thinner than the adjacent wall and has the thickness d of the side wall of the flap 30 in the unassembled state. In this exemplary embodiment, the film hinge 35 extends over a length of the side wall 1.

(57) The ratio of length 1 to thickness d is preferably between 0.5 and 5, particularly preferably between 1 and 3 and quite particularly preferably between 1.5 and 2.5. This provides a region of sufficient length to reduce the risk of breakage.

(58) The thickness d of the film hinge is preferably between 0.2 and 1.0 mm.

(59) FIG. 14 is a side view of the closure cap 1 and FIG. 15 is a sectional view along the line A-A of FIG. 14. The section also runs through the lateral latching element 26, which encloses the corners of the flap 30 opposite the film hinge 35 in the assembled state. The latching element 26 also comprises a hook 26a with a contact surface 26b for the flap 30.

(60) Preferably, in contrast to the latching element 25, the contact surface in the unassembled state is not aligned parallel to the plate-shaped flap 30, but runs obliquely. In particular, this can facilitate the escape of the hook 26a during latching. The hooks 26a enclose the corners of the flap 30 such that they cannot move like a flat leaf spring like the latching element 25 on the long side of the flap 30. The latching element 26 can also serve to position the flap 30 and absorbs forces acting in the direction of the axis of the film hinge 36, for example when a spike is inserted obliquely.

(61) FIG. 16 is a plan view of the underside of the closure cap 1.

(62) FIG. 17 is a sectional view along the line A-A, which runs through the latching element 26 at a different location than the section according to FIG. 15. The latching element 26 encloses the corner of the flap 26. In the assembled state, the contact surface 26b for the flap is aligned obliquely to the flap 30.

(63) FIG. 18 shows a schematic view of a container 2 according to the invention. The cap 1 represented above is connected to a lower part 3, which provides most of the volume of the container 2.

(64) FIG. 19 shows the steps of a method according to the invention in accordance with an exemplary embodiment of the invention.

(65) First, a closure cap 1 is provided which has a base body 20 with at least one opening 24a, 24b for a connection 10a, 10b, with the closure cap 1 having on an inner side a flap 30 with at least one opening 32a, 32b which can be folded relative to the base body 20. This may in particular be the closure cap 1 represented above.

(66) A sealing element 40 is then inserted inside into the opening 24a, 24b of the base body or into the opening 32a, 32b of the flap 30.

(67) The flap 30 is then folded or pivoted onto the base body 20, with the flap 30 being fixed on the base body 20 in an end position and thus fixing the sealing element 40 between the opening 24a, 24b of the base body 20 and the opening 32a, 32b of the flap 30.

(68) The invention makes it possible to provide a closure cap for a medical container that can be assembled easily and safely.

LIST OF REFERENCE NUMERALS

(69) 1 Closure cap 2 Container 3 Head part 10a, 10b Connection 11a, 11b Break-off piece 12a, 12b Wing grip 13a, 13b Predetermined breaking point 20 Base body 20a Bottom (of the base body) 20b Side wall (of the base body 21 Connection flange 22a, 22b Connection nozzle 23 Groove 24a, 24b Opening 25 Latching element 25a Hook 25b Contact surface 25c Inclined surface 26 Lateral latching element 26a Hook 26b Contact surface 27a, 27b Annular groove 28 Web 30 Flap 31a, 31b Annular web 32a, 32b Opening 33 Chamfer 34 Base 35 Film hinge 40 Sealing element 41 Piercing region 42 Groove 43 Ring 44 Ring 45 Marking 46,47 Slot