EP2373277B1 - Closure cap for receptacles for receiving medical liquids and receptacle for receiving medical liquids - Google Patents

Description

The invention relates to a closure cap for containers for holding medical fluids, in particular for filled with infusion or transfusion solutions or liquids for enteral nutrition containers. Moreover, the invention relates to a container for receiving medical fluids, in particular a bottle, with such a cap.

As a blow-fill-seal method (BFS method), a method is known in which containers, such as bottles of extruded PE or PP, in a single operation sterile and pyrogen-free blown into a desired shape and immediately after cooling with a sterile filling aseptically filled and hermetically sealed. The containers produced by the bubble-fill-seal method, in particular bottles, are also referred to as BFS containers.

When the known BFS containers are used to hold sterile medical fluids, for example infusion solutions, the containers require a closure cap which allows the infusion solution to be transferred to the patient by means of an infusion device. The addition of medication to the infusion solution should also be possible.

From the WO 2008/095665 A1 is a cap for a container for receiving medical fluids, in particular a BFS bottle known. The known closure cap has a cover part and an edge part, wherein an injection part is arranged in the cover part. The injection part has an outwardly pointing connection part with a conical recess for sealingly receiving the conical shank of a needleless injection syringe and an inwardly pointing closure part into which a self-sealing membrane is inserted. Next to the Injection part has the cap on a sampling part for removing a medical fluid with a spike.

A cap which has both a removal part for removing liquid and an injection part for injecting an additive, is also from the WO 2006/042579 A1 known.

The from the WO 2008/095665 A1 and those from the WO 2006/042579 A1 Known caps are characterized in that both caps have only one sampling part and an injection part. In practice, both caps have proven themselves. The injection part allows the subsequent injection of an additive or the injection of several additives in succession into the medical fluid. The injection part is closed sterile by a break-off part. The disadvantage is that the container after breaking off the break-off of Zuspritzteils Although sealed with the self-sealing membrane, but the connection part of the injection part is exposed to a non-sterile environment. Therefore, there is thus basically the risk of contamination of the unprotected on the outside of the injection part, which proves to be disadvantageous when a further additive is to be injected at the injection part.

Caps for enteric nutrient solutions contained containers are also from the US-A-5,125,522 and U.S.-A-4,951,845 known. These caps have only one sampling point. In addition to the removal point, the known closure caps on a vent, which is closed with a sterile filter.

The WO 2006/115969 A3 describes a cap for a container having a plurality of openings of different design, such as round or star-shaped openings. All openings are circumferentially distributed around the center of the cap.

For connection of medical devices, conical connections with a conical shank and a conical sleeve are known in medical technology whose conical surfaces are normalized. The Non-lockable conical connections with normalized conical surfaces are referred to as Luer connectors and the lockable conical connections as Luer-Lock connectors. Luer syringes without screw connections and Luer lock syringes with screw connections are also known.

The invention has for its object to provide a cap for containers for receiving medical fluids, especially for infused with infusion or Transfüsionslösungen or liquids for enteral nutrition containers that is particularly easy to handle and is universally applicable. Moreover, it is an object of the invention to provide a container for containing medical fluids, in particular a bottle, which is easy to handle and universally applicable.

The solution of these objects is achieved according to the invention with the features specified in the claims 1 and 17. Preferred embodiments of the invention are subject of the dependent claims.

The closure cap according to the invention is characterized by two injection parts arranged separately from one another, in each case for injecting an additive. The one injection part is used for injecting an additive with a needleless injection syringe, while the other injection part is used for injecting an additive with a syringe having a needle (cannula). Therefore, it is possible to inject various additives into the medical fluid contained in the container with both a needleless syringe and a hypodermic needle syringe. Thus, the closure cap according to the invention is universally applicable.

For example, if a first additive has been injected via the first injection part, a second additive may be injected via the second injection part. Preferably, both injection parts are sealed tightly with a break-off part. Should the break-off part of one injection part be broken off, the other injection part continues to be protected by the break-off part which has not yet been broken off. This has the advantage that the not yet used Zuspritzteil can not be contaminated.

In a preferred embodiment, the closure cap has a lid portion and a rim portion, the lid portion having an inner portion and an outer portion projecting outwardly from the inner portion. The first and second injection part and the extraction part are preferably arranged on the outer outwardly projecting portion of the lid part. Thus, the injection point and the extraction point jump outwards so that the injection points and the removal point on the closure cap are easily accessible.

The first and second injection part and the removal part are preferably arranged in a preferred embodiment on the outer portion of the lid part in a row preferably close to each other. In this case, the outer portion of the cover part should extend as far as possible over the entire width of the cover part. This is sufficient space for the arrangement of Zuspritzteile and the sampling part available.

An alternative embodiment provides an offset arrangement of the injection parts and the removal part on the outer portion of the cover part. In this alternative embodiment, the outwardly projecting portion of the lid portion preferably has a substantially rectangular shape so that there is sufficient space for the injection portions and the extraction portion.

The break off parts for closing the injection parts and the removal part preferably have lateral grip tabs, which preferably extend over the outer part of the cover part. This allows the grip tabs to be easily grabbed from the side.

The injection part for the needleless injection syringe has an outwardly facing connecting part with a recess for receiving the conical shank of the syringe and an inwardly facing closure part, in which a self-sealing membrane is arranged. The outwardly pointing connection part of the first injection part preferably has an external thread, so that a known Luer-lock syringe can be connected to the connection part. But it is also possible that the connection part the Zuspritzteils has no external thread, so that only the connection of a known Luer syringe is possible.

The container according to the invention, in particular infusion or transfusion container or container for receiving an enteral nutrient solution, is preferably designed as a bottle, in particular SBM bottle (SBM: Stretch Blow Molding), which is closed with the closure cap according to the invention.

In the following, two embodiments of the invention will be explained in more detail with reference to the drawings.

Fig. 1

Ein Ausführungsbeispiel der erfindungsgemäßen Verschlusskappe in der Draufsicht, bei der die Zuspritzteile und der Entnahmeteil in Reihe angeordnet sind,

Fig. 2

die Verschlusskappe von Fig. 1 in der Unteransicht,

Fig. 3

die Verschlusskappe von Fig. 1 in geschnittener Darstellung, wobei der Abbrechteil von einem Zuspritzteil abgebrochen ist, um ein Additiv mit einer Spritze zuzuspritzen, die eine Nadel aufweist,

Fig. 4

die Verschlusskappe von Fig. 1 in geschnittener Darstellung, wobei der Abbrechteil von dem anderen Zuspritzteil abgebrochen ist, um ein Additiv mit einer nadellosen Spritze zuzuspritzen,

Fig. 5

die Verschlusskappe von Fig. 1 in geschnittener Darstellung, wobei der Abbrechteil von dem Entnahmeteil zur Entnahme von Flüssigkeit mit einen Spike abgebrochen ist,

Fig. 6

ein zweites Ausführungsbeispiel der erfindungsgemäßen Verschlusskappe in der Ansicht von oben, bei der die Zuspritzteile und der Entnahmeteil versetzt zueinander angeordnet sind,

Fig. 7

die Verschlusskappe von Fig. 6 in der Ansicht von unten und

Fig. 8

ein Ausführungsbeispiel eines erfindungsgemäßen Behältnisses mit einer erfindungsgemäßen Verschlusskappe.

Show it:

Fig. 1

An embodiment of the closure cap according to the invention in plan view, in which the injection parts and the removal part are arranged in series,

Fig. 2

the cap of Fig. 1 in the bottom view,

Fig. 3

the cap of Fig. 1 in a sectional view, wherein the break-off part is broken off from an injection part to inject an additive with a syringe having a needle,

Fig. 4

the cap of Fig. 1 in a sectional view, wherein the break-off part is broken off from the other injection part to inject an additive with a needleless syringe,

Fig. 5

the cap of Fig. 1 in a sectional representation, wherein the break-off part is broken off from the removal part for taking out liquid with a spike,

Fig. 6

A second embodiment of the closure cap according to the invention in the view from above, in which the injection parts and the removal part are arranged offset from one another,

Fig. 7

the cap of Fig. 6 in the view from below and

Fig. 8

An embodiment of a container according to the invention with a closure cap according to the invention.

The Fig. 1 and 2 show a first embodiment of the closure cap according to the invention in plan view and the bottom view, while the Fig. 3 to 5 show the cap in a sectional view, wherein injected with an injection syringe, an additive or withdrawn liquid with a spike. The cap is with the exception of pierceable membranes a one-piece plastic part that can be produced inexpensively in large quantities.

The closure cap 1 has a lid part 2 and a rim part 3. The lid part 2 has a flat inner portion 4, from which an outer portion 5 projects outwardly. The outer portion 5 of the lid part 2 has an elongate shape with two substantially straight-line portions 5A, followed by substantially semicircular portions 5B on both sides. The outer portion 4 extends over the entire width of the inner portion 4 of the lid part 2. At the top of the outer portion 5 of the lid part 2 are easily accessible to the user a first Zuspritzteil 6, a second injection part 7 and a removal part 8. Der first injection part 6 is used for injecting an additive with a syringe having a needle ( Fig. 3 ), while the second injection part 7 is used for injecting an additive with a needleless syringe ( Fig. 4 ). The sampling part 8 is used to remove liquid with a spike ( Fig. 5 ).

The two Zuspritzteile 6 and 7 and the removal part 8 are arranged on the outer portion 5 of the cover part 2 close together lying in line. They lie on an axis 9, which corresponds to the longitudinal axis of the outer portion 5 of the cover part 2. The two Zuspritzteile 6 and 7, which have a smaller diameter than the removal part 8 are arranged close to each other lying, while the removal part 8 is close to the two Zuspritzteilen 6, 7.

The following are with reference to the Fig. 3 to 5 the two Zuspritzteile 6, 7 and the removal part 8 described in detail.

The first injection part 6 at the outer edge of the cover part 2 for injecting an additive with a syringe ( Fig. 3 ), which has a needle, has an outwardly facing annular projection 10 which encloses the injection site. The annular projection 10 is closed by a break-off part 11 which adjoins the upper end of the annular section 10 via a ring-breaking zone 12 ( Fig. 4 and 5 ). The break-off part 11 has a round cap 13, to which via a narrow web 14 a gripping lug 15 connects, which extends beyond the outer portion 5 of the lid part 2 and down to the edge portion 3 of the cap 1.

Of the annular portion 10 of the first Zuspritzteils 6, a closure member 16 inwardly, which has a recess 17. In the recess 17 of the closure part 16, a pierceable, self-sealing membrane 18 is inserted. The membrane 18 is set snapping into the recess 16. The recess 17 has an upper cylindrical portion 16 A, which adjoins the annular portion 10 of the first injection part 6. The upper cylindrical portion 16A is followed by a lower cylindrical portion 16B having a larger inner diameter than the upper cylindrical portion 16A. The self-sealing membrane 18 has correspondingly a lower cylindrical portion 18A with a larger outer diameter, which sits in the lower cylindrical portion 16B of the recess 16. The lower cylindrical portion 18A of the diaphragm 18 is adjoined by an upper cylindrical portion 18B having a smaller outer diameter, which fits into the upper cylindrical portion 16A of the recess 17.

For clamping fixation of the membrane 18 in the recess 17, the closure member 16 has an inwardly projecting edge 19 at the lower end of the Closure part 16, which engages under the membrane 18. The membrane 18 has a flat top and bottom and is not slotted. This ensures that the membrane after pulling out the cannula of a syringe safely seals again and no liquid leaks.

The second injection part 7, which is arranged centrally, has an outwardly pointing connection part 20 for connecting a needleless Luer-Lock syringe ( Fig. 4 ). Otherwise, the second injection part 7 does not differ from the first injection part 6. The connection part 20 of the second injection part has a conical recess 20A for sealingly receiving the conical shaft of the syringe and an external thread 20B. The conical recess 20A and the external thread 20 B are formed such that a commercially available Luer-lock syringe can be connected to the connector part. The connection part 20 is closed with a break-off part 21, which is connected via a ring breaking zone 22 to the upper end of the connection part. The break-off part 22 has a round cap 23, to which a lateral tab 25 connects via a narrow web 24, which extends over the outer portion 5 of the cover part 2 to the outside and up to the inner portion 4 of the cover part 2.

The second injection part 7 also has a closure part 26, which corresponds to the closure part 16 of the first injection point 6. The closure part 26 of the second injection point again has a recess 27 in which a membrane 28 is fixed by clamping. The closure part 26 of the second injection part 7 differs from the closure part of the first injection part 6 by the membrane 28, which has a lower annular portion 28A, which is followed by a central plate 28B, an upper plate-shaped portion 28C having a trough-shaped recess 28D , The dish-shaped portion 28C of the membrane 28 is provided with one or more slots, for example, slotted crosswise.

The removal part 8 of the closure cap 1 has an outwardly pointing connection part 29 for connecting the spike of an infusion device ( Fig. 5 ). The connection part 29 has a recess 30 into which the spike of the infusion device is inserted. The recess 30 has an upper conical portion 30A and a lower one cylindrical portion 30B, wherein the upper conical portion for centering the spike and the lower cylindrical portion for sealingly receiving the spike is used. The recess 30 of the connecting part 29 is closed by a break-off part 31, which is connected via a ring breaking zone 32 to the upper end of the connecting part. The break-off part 31 again has a lateral grip tab 33, which, like the grip tab of the break-off part of the first injection part, protrudes beyond the outer section 5 of the cover part 2 and extends up to the edge part 3 of the closure cap 1.

The removal part 8 has an inwardly projecting closure part 34 with a recess 35, in which again a pierceable, self-sealing membrane 36 is fixed by clamping. The self-sealing membrane 36 of the extraction part 8 has an outer annular upper portion 36A, to which a plate-shaped lower portion 36C connects via a central web 36B. The central web 36B of the membrane 36 is clamped by an inwardly projecting edge 37 at the lower end of the closure member 34.

The cap 1 has at the lower edge of the edge part 3 a bead-shaped edge 38 which has a circumferential groove 39 on the underside. The cap can be placed on a bottle, wherein the upper edge of the bottle neck engages in the groove 29 of the bead-shaped edge 38 of the cap 1.

Fig. 8 shows a bottle 40, in particular an SMB bottle, which is closed with the closure cap 1 according to the invention. The cap 1 is firmly seated on the bottle neck 41 of the bottle 40, which is filled, for example, with an infusion solution. Since the bottleneck is not closed in the head area, but is open, the liquid is in direct contact with the cap. This makes it possible to inject a medication with a needleless injection syringe or with a syringe with a needle. The cap can be designed as a screw cap, which is screwed onto the bottle neck of the bottle. But it is also possible to weld the cap with the bottleneck.

Hereinafter, the handling of the cap 1 will be described.

To remove a liquid, for example an infusion solution, the break-off part 31 is broken off from the closure cap 1, so that the membrane 36 of the removal part 8 is exposed. Then the spike of the infusion device is connected to the connection part 29 of the removal part 8 ( Fig. 5 ). When a drug is to be injected with a syringe with a needle, the break-off part 11 of the first injection part 6 is broken so that the membrane 18 of the first injection part can be pierced with the needle (cannula) of the syringe. However, the second injection point still remains protected by the associated break-off part ( Fig. 3 ). In the event that a drug with a needleless injection syringe (Luer-lock syringe) to be re-injected, the break-off part 21 of the second Zuspritzteils 7 is stopped, after which the Luer-lock syringe with the connection part 20 of the second Zuspritzteils 7 are screwed can Fig. 4 ).

The 6 and 7 show an alternative embodiment of the closure cap 1 'according to the invention, which differs from that described with reference to FIGS Fig. 1 to 5 described cap differs only by the arrangement of the two Zuspritzteile and the removal part on the outer portion of the lid part. Therefore, the same reference numerals are used for the corresponding parts. In the embodiment of the 6 and 7 the outer portion 5 of the cover part 2 of the closure cap 1 'has a substantially rectangular shape with rounded corners. At the top of the upper portion 4 of the cover part 2, the two Zuspritzteile 6, 7 and the removal part 8 are arranged offset to one another. In this case, the first injection part 6 and the removal part 8 lie on one half and the second injection part 7 on the other half at the top of the outer portion 5 of the cover part 2. The grip tabs 15, 25, 33 of the injection parts 6, 7 and the removal part. 8 point radially outward. They extend beyond the outer portion 5 of the cover part 2 to the outside and reach down to the edge portion 3 of the cap 1 down. The individual accesses are marked with the upwardly or downwardly pointing arrows 42 on the grip tabs 15, 25, 33 of the breakaway parts 11, 21, 31 as injection parts or removal part.

Claims (17)

1. A closure cap for receptacles for receiving medical liquids, in particular for receptacles filled with infusion or transfusion solutions or liquids for enteral nutrition, with
   a withdrawal part (8) for withdrawing the medical liquid using a spike, wherein the removal part (8) has an outwardly directed connector part (29), with a recess (30) for receiving the spike, and an inwardly directed closure part (34), in which a self-sealing membrane (36) is arranged with which the recess (30) of the withdrawal part (8) is closed, and
   an injection part (7) separate from the withdrawal part (8) and designed for injecting an additive into the medical liquid using a needleless injection syringe, wherein the injection part (7) has an outwardly directed connector part (20), with a recess (20A) for receiving the conical stem of the syringe, and an inwardly directed closure part (26), in which a self-sealing membrane (28) is arranged with which the recess (20A) of the injection part (7) is closed,
   characterized in that
   the closure cap has a second injection part (6) separate from the first injection part (7) and designed for injecting an additive into the medical liquid using an injection syringe that has a needle, wherein the second injection part (6) has an inwardly directed closure part (16), with a recess (17) in which a self-sealing membrane (18) is arranged with which the recess (17) of the closure part (16) is closed.
2. The closure cap as claimed in claim 1, characterized in that the closure cap has a lid part (2) and an edge part (3), wherein the lid part (2) has an inner portion (4) and an outer portion (5) protruding outward from the inner portion.
3. The closure cap as claimed in claim 2, characterized in that the first and second injection parts (6, 7) and the withdrawal part (8) are arranged lying next to one another in a row on the outer portion (5) of the lid part (2).
4. The closure cap as claimed in claim 2, characterized in that the first and second injection parts (6, 7) and the withdrawal part (8) are arranged offset in relation to one another on the outer portion (5) of the lid part (2).
5. The closure cap as claimed in one of claims 1 through 4, characterized in that the connector part (20) of the first injection part (7) has an outer thread (20B).
6. The closure cap as claimed in one of claims 1 through 5, characterized in that the connector part (20) of the first injection part (7) is closed with a break-off part (21), which is attached to the connector part (20) of the first injection part (7) via an annular break zone (22).
7. The closure cap as claimed in claim 6, characterized in that the break-off part (21) of the connector part (20) of the first injection part (7) has a lateral grip tab (25), which extends across the outer portion (5) of the lid part (2).
8. The closure cap as claimed in one of claims 1 through 7, characterized in that the second injection part (6) has an outwardly directed annular shoulder (10), which is closed with a break-off part (11) attached to the annular shoulder (10) of the second injection part (6) via an annular break zone (12).
9. The closure cap as claimed in claim 8, characterized in that the break-off part (11) of the second injection part (6) has a lateral grip tab (15), which extends across the outer portion (5) of the lid part (2).
10. The closure cap as claimed in one of claims 1 through 9, characterized in that the closure part (26) of the first injection part (7) and/or the closure part (16) of the second injection part (6) and/or the closure part (34) of the withdrawal part (8) has an inwardly projecting edge (19, 37), which fixes and clamps the-self-sealing membrane of the closure part of the first and second injection parts and of the withdrawal part in the recess, respectively.
11. The closure cap as claimed in one of claims 1 through 10, characterized in that the recess (16) of the first and second injection parts (7, 6) in each case has a first cylindrical upper portion (16A) and, adjoining the first cylindrical portion, a second cylindrical lower portion (16B), wherein the second cylindrical portion has a greater diameter than the first cylindrical portion.
12. The closure cap as claimed in claim 11, characterized in that the self-sealing membrane (28) of the first injection part (7) has an annular lower portion (28A), which is arranged in the second cylindrical portion of the recess, and a plate-shaped upper portion (18C), which adjoins the annular portion via a central web (28B) and is arranged in the first cylindrical portion.
13. The closure cap as claimed in one of claims 1 through 12, characterized in that the self-stealing membrane (28) of the first injection part (7) has a cup-shaped depression (28D).
14. The closure cap as claimed in one of claims 1 through 13, characterized in that the self-sealing membrane (36) of the withdrawal part (8) has an outer annular upper portion (36A), to which a plate-shaped lower portion (36C) is adjoined via a central web (36B), wherein the outer annular portion of the membrane is held with a clamping action.
15. The closure cap as claimed in one of claims 1 through 14, characterized in that the connector part (29) of the withdrawal part (8) is closed with a break-off part (31), which is attached to the connector part (29) of the withdrawal part (8) via an annular break-off zone (32).
16. The closure cap as claimed in claim 15, characterized in that the break-off part (31) of the withdrawal part (8) has a lateral grip tab (33), which extends across the outer portion (5) of the lid part (2).
17. A receptacle, in particular a bottle, having a closure cap as claimed in one of claims 1 through 16.

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