HK1164109B - Closure cap for receptacles for receiving medical liquids and receptacle for receiving medical liquids - Google Patents

Description

Closure cap for a container for medical liquids and container for medical liquids

Technical Field

The invention relates to a sealing cover for a container for containing medical liquid, in particular to a sealing cover for a container for containing transfusion or injection liquid or enteral nutrient solution. The invention further relates to a container, in particular a bottle, for a medical liquid, which is equipped with such a closure.

Background

As a blow-fill-seal method (BFS process), a method is known in which containers, in particular bottles, are blown from extruded PE or PP in a single operation in a sterile and pyrogen-free manner into a desired shape, directly after cooling a sterile filling mass is filled aseptically and closed in a gas-tight manner. Containers, in particular bottles, produced by this blow-fill-seal method are referred to as BFS containers.

If the known BFS containers are used for sterile medical liquids, such as injections, these containers require a closure which allows the injections to be delivered to the patient using an infusion set. It is equally feasible to add the drug to the injection solution.

A closure for containers for medical liquids, in particular BFS bottles, is disclosed in WO 2008/095665a 1. Such closures are known to have a cover part and an edge part, wherein an injection part is provided in the cover part. The injection part has an outwardly directed connecting part which is provided with a conical recess for the sealed accommodation of a conical stem of a needleless syringe; there is also an inwardly directed closure into which a self-sealing septum is inserted. The cap has a removal part for removing the medical liquid by means of a suction head, in addition to the injection part.

A closure cap is also known from WO 2006/042579a1, which is also provided with a removal portion for removing the medical liquid and an injection portion for injecting an additive into the medical liquid.

The closures disclosed in WO 2008/095665a1 and WO 2006/042579a1 are characterized in that: both closures are provided with only one extraction portion and one injection portion. In practice both closures have proven to be reliable. The injection part allows for subsequent injection of one additive or a plurality of additives sequentially into the medical liquid. The injection part is closed aseptically by a removal part. The disadvantages are that: after removal of the removal part of the injection part, the container is closed tightly with a septum sealed to itself, but the connection part of the injection part is exposed to a non-sterile environment. In principle, there is therefore a risk of contamination of the injection site, the outside of which is unprotected, which is disadvantageous when another additive is to be injected onto the injection site.

Closures for containers containing enteral nutrition liquids are disclosed in US-A-5125522 and US-A-4951845. These closures have only one removal point, and in addition to the removal point, the known closures have a vent hole which is closed by a sterile filter.

WO 2006/115969A3 describes a closure for a container having a plurality of differently configured vent holes, for example circular or star shaped holes. All the holes are circumferentially distributed around the centre of the closure.

For connecting medical instruments, tapered connection mechanisms with tapered rods and tapered sleeves are known from the medical technology, the tapers of which are standardized. An unlockable taper connection with a standardized taper is known as a Luer connector; the lockable taper connection is referred to as a Luer-lock connector. Luer syringes without a screw connection and Luer-lock syringes with a screw connection are also known.

Disclosure of Invention

The object of the invention is to provide a closure for containers for medical liquids, in particular for containers for injections or infusions or for containers for enteral nutrition, which is particularly easy to handle and is universal. It is a further object of the present invention to provide a container for medical liquids, in particular a vial, which is simple to handle and versatile.

According to the invention, the above object is achieved by the features of claim 1 and claim 17. Preferred embodiments of the invention are the subject matter of the dependent claims.

The closure proposed by the invention is characterized in that two injection points are provided, which are arranged separately from one another, in order to inject in each case one additive. An injection portion for injecting an additive using a needleless syringe; and the other for injecting an additive using a syringe having a needle (injection cannula). Thus, the medical fluid contained in the container may be injected with different additives using either a needleless syringe or a needle syringe. So that the closure proposed by the present invention is versatile.

For example, if a first additive is injected through the first injection part, a second additive may be injected through the second injection part. Preferably, both injection openings are sealed with the removal opening. If the removal portion of one injection portion is removed, the other injection portion is still protected by the removal portion that has not been removed. The advantages are that: the injection part that has not been used is not contaminated.

According to a preferred embodiment of the invention, the cover has a cover part and an edge part, wherein the cover part has an inner section and an outer section which projects outwards from the inner section. The first and second injection and removal parts are preferably arranged on an outwardly projecting section of the cover part. In this way, both the injection site and the removal site protrude outwardly, thereby making both the injection site and the removal site easily accessible on the closure.

According to a preferred embodiment, the first and second inlet and outlet are arranged in a row, preferably closely next to each other, on the outer section of the cover. The outer section of the cover should extend over the entire width of the cover as far as possible. This provides sufficient space for the placement of the injection and extraction sections.

In another embodiment, the injection part and the removal part are arranged offset on the outer section of the cover part. According to this further embodiment, the outwardly projecting section of the cover preferably has a substantially rectangular shape, so that sufficient space is available for the filling and removal part.

The removal part for closing the filling part and the removal part preferably has lateral actuating tabs, which preferably extend over the outer section of the cover part. This makes it possible to easily grasp the operating tab from the side.

The injection part for a needleless syringe comprises an outwardly directed connecting part provided with a recess for receiving a conical stem of the syringe and an inwardly directed closing part in which a self-sealing septum is arranged. The outwardly directed connection of the first injection part preferably has an external thread, so that a known Luer-lock syringe can be connected to this connection. However, there is also the possibility that the connection of the injection part is not externally threaded, so that only the connection of one known Luer syringe can be realized.

The container proposed according to the invention, in particular an infusion container or an injection container or a container for enteral nutrient solutions, is preferably designed as a bottle, in particular as an SBM (stretch blow molding) bottle, which is closed with the closure proposed according to the invention.

Drawings

Two embodiments of the present invention will be described in detail below with reference to the accompanying drawings. The attached drawings show that:

FIG. 1 is a top view of one embodiment of a closure according to the present invention, in which the injection portion and the withdrawal portion are arranged side by side;

FIG. 2 is a bottom view of the closure shown in FIG. 1;

FIG. 3 is a cross-sectional view of the closure of FIG. 1, wherein the removal portion has been removed from an injection portion to inject an additive using a syringe having a needle;

FIG. 4 is a cross-sectional view of the closure of FIG. 1, wherein the removal portion has been removed from the other injection portion to inject an additive using a needleless syringe;

FIG. 5 is a cross-sectional view of the closure shown in FIG. 1, wherein the removing portion has been removed from the removing portion to remove the medical fluid using a tip;

FIG. 6 is a top view of a second embodiment of the closure according to the present invention, in which the injection part and the withdrawal part are arranged offset from each other;

FIG. 7 is a bottom view of the closure shown in FIG. 6; and

fig. 8 shows an embodiment of a container according to the invention, provided with a closure according to the invention.

Detailed Description

Figures 1 and 2 show a top view and a bottom view of a first embodiment of a closure according to the present invention; fig. 3 to 5 show cross-sectional views of the closure, in which an additive is injected by means of a syringe or a medical liquid is withdrawn by means of a pipette. The closure is a unitary plastic component, other than the pierceable septum, which can be manufactured in large quantities at a cost.

The closure 1 has a cover part 2 and an edge part 3. The cover 2 has a flat inner section 4 from which an outer section 5 projects outwards. The outer section 5 of the cover 2 has an elongated shape with two substantially rectilinear sections 5A to which substantially semicircular sections 5B are connected on both sides. The outer section 5 extends over the entire width of the inner section 4 of the cover 2. On the upper face of the outer section 5 of the cap 2, there are a first injection portion 6, a second injection portion 7 and a take-out portion 8, for the convenience of the user. The 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 using a syringe without a needle (fig. 4). The removing section 8 is used for removing the medical liquid by one tip (fig. 5).

The two injection parts 6 and 7 and the extraction part 8 are arranged closely side by side on the outer section 5 of the cover part 2. Here, they lie on an axis 9 which corresponds to the longitudinal axis of the outer section 5 of the cover 2. The two injection portions 6 and 7, whose diameter is smaller than the extraction portion 8, are arranged closely side by side with each other; and the extraction part 8 is located immediately beside the two injection parts 6, 7.

The two injection portions 6, 7 and the take-out portion 8 will be described in detail below with reference to fig. 3 to 5.

The first injection site 6 on the outer edge of the cover part 2 for injecting an additive with a syringe with a needle (fig. 3) has an outwardly directed annular flange 10 which surrounds the injection site. The annular flange 10 is closed with a removal portion 11 which is connected to the upper end of the annular section 10 via an annular fracture zone 12 (fig. 4 and 5). The removal part 11 has a round cover 13 to which an operating tab 15 is connected via a narrow bridge 14, which extends over the outer section 5 of the cover part 2 and down to the edge part 3 of the closure 1.

Proceeding from the annular section 10 of the first inlet 6, a closure 16 is directed inwards, which has a recess 17. A pierceable, self-sealing septum 18 is mounted in the recess 17 of the closure 16. In this case, the diaphragm 18 is fixed in a snap-in manner in the recess 17. The closure 16 has an upper cylindrical section 16A which is connected to the annular section 10 of the first injection part 6. Connected to the upper cylindrical section 16A is a lower cylindrical section 16B having an inner diameter greater than the inner diameter of the upper cylindrical section 16A. The self-sealing septum 18 has a corresponding lower cylindrical section 18A of larger outer diameter that is located in the lower cylindrical section 16B of the closure 16. An upper cylindrical section 18B of smaller outer diameter is connected to the lower cylindrical section 18A of the diaphragm 18, said upper cylindrical section being accommodated in the upper cylindrical section 16A of the closure 16.

In order to fix the diaphragm 18 in the recess 17 in a clamping manner, the closure 16 has an inwardly projecting edge 19 on the lower end of the closure 16, which edge acts on the diaphragm 18 from below. The diaphragm 18 has flat upper and lower faces and is unslotted. This is achieved: after pulling out the needle of the syringe, the septum seals again reliably and the liquid flows out.

The second injection site 7, which is arranged in the central position, has an outwardly directed connection 20 for connecting a needleless Luer-lock syringe (fig. 4). In other respects, the second injection portion 7 is not different from the first injection portion 6. The connecting portion 20 of the second injection part 7 has a conical recess 20A for sealingly receiving the conical stem of the syringe and has an external thread 20B. The tapered recess 20A and the external thread 20B are designed so that a commercially available Luer-lock syringe can be connected to the connection. The connection 20 is closed by means of a removal portion 21 which is connected to the upper end of the connection via an annular breaking zone 22. The removal part 21 has a round cover 23 to which a lateral actuating tab 25 is connected via a narrow bridge 24, which passes outwardly over the outer section 5 of the cover 2 and extends as far as the inner section 4 of the cover 2.

The second injection part 7 also has a closing part 26 corresponding to the closing part 16 of the first injection part 6. The closure part 26 of the second injection part also has a recess 27 in which a diaphragm 28 is clampingly fixed. The closure 26 of the second injection part 7 differs from the closure of the first injection part 6 by a diaphragm 28 which has a lower annular section 28A to which an upper disk section 28C is connected via an intermediate bridge 28B, which has a basin-shaped recess 28D. The dished section 28C of the diaphragm 28 is provided with one or more slots, for example, cross-slotted.

The removal portion 8 of the cover 1 has an outwardly directed connection 29 for the connection of a suction head of an infusion set (fig. 5). The connecting part 29 has a recess 30 into which the tip of the infusion set can be inserted. The recess 30 has an upper conical section 30A for centering the tip and a lower cylindrical section 30B; the lower cylindrical section is then used to sealingly receive the pipette tip. The recess 30 of the connecting part 29 is closed by means of a removal part 31 which is connected to the upper end of the connecting part via an annular breaking zone 32. The removal part 31 also has a lateral actuating tab 33 which, like the actuating tab of the removal part of the first filling part, projects outwardly beyond the outer section 5 of the cover part 2 and extends as far as the edge part 3 of the closure 1.

The removal part 8 has an inwardly projecting closure 34 which is provided with a recess 35 in which a pierceable, self-sealing septum 36 is also clampingly secured. The self-sealing septum 36 of the extraction portion 8 has an outer annular upper section 36A to which a disk-shaped lower section 36C is connected via an intermediate bridge 36B. The central bridge 36B of the diaphragm 36 is clampingly retained by an inwardly projecting rim 37 on the lower end of the closure 34.

The closure 1 has a flange-shaped edge 38 on the lower edge of the edge part 3, which has a circumferential groove 39 on its underside. The closure can be placed on a bottle, wherein the upper edge of the bottle neck engages in the groove 39 of the flange-shaped edge 38 of the closure 1. The closure can be placed on a bottle, wherein the upper edge of the bottle neck engages in the groove 39 of the flange-shaped rim 38 of the closure 1.

Fig. 8 shows a bottle 40, in particular an SMB bottle, which is closed with a closure 1 according to the invention. The closure 1 is firmly seated on the neck 41 of a bottle 40 which has been filled, for example, with an infusion or injection solution. Since the neck of the bottle is not closed in its head region, but is open, the liquid comes into direct contact with the closure. There is thus the possibility of injecting a medicament with a needleless syringe or with a needle-carrying syringe. The closure may be designed as a screw cap which is screwed onto the neck of the bottle. But there is also another possibility that the closure can be welded to the neck of the bottle.

The operation of the closure 1 will now be described.

In order to remove a medical liquid, for example, an infusion liquid, the removal portion 31 is first removed from the cap 1, and the septum 36 of the removal portion 8 is exposed. The tip of the infusion set is then connected to the connection 29 of the extraction section 8 (fig. 5). If a needle-equipped syringe is to be used for injecting a drug, the removal portion 11 of the first injection portion 6 is removed so that the septum 18 of the first injection portion can be pierced by the needle of the syringe. But the second implant site is still protected by the associated extractor (fig. 3). In order to allow a needle-free syringe (Luer-lock type syringe) to be used for refilling with a medicament, the removal portion 21 of the second injection portion 7 is removed and the Luer-lock type syringe can be screwed together with the connecting portion 20 of the second injection portion 7 (fig. 4).

Fig. 6 and 7 show an alternative embodiment of the closure 1' according to the invention, which differs from the closure described with reference to fig. 1 and 5 only in the arrangement of the two injection points and the removal point on the outer section of the cover. Therefore, the same reference numerals are used for corresponding portions. According to the embodiment shown in fig. 6 and 7, the outer section 5 of the cover part 2 of the closure 1' has a substantially rectangular shape with rounded corners. On the upper face of the upper section 4 of the cover 2, the two injection points 6, 7 and the removal point 8 are arranged offset to one another. The first injection site 6 and the removal site 8 are located on one half of the upper side of the outer section 5 of the cover 2, while the second injection site 7 is located on the other half of the upper side. The operating tabs 15, 25, 33 of the injection sections 6, 7 and the removal section 8 are all directed radially outward. These tabs extend outwardly over the outer section 5 of the cover 2 and down to the edge 3 of the closure 1. The proximity of the respective operating positions is indicated by the upward or downward pointing arrows 42 on the operating tabs 15, 25, 33 of the removal sections 11, 21, 31 as injection or withdrawal sections.

Claims (19)

1. A closure for a container for holding a medical fluid, the closure comprising:

a removal part (8) for removing medical liquids with a pipette tip, the removal part (8) comprising an outwardly directed connection part (29) with a cavity (30) for receiving the pipette tip and an inwardly directed closure part (34) in which a self-sealing diaphragm (36) is arranged, with which diaphragm the cavity (30) of the removal part (8) is closed;

a first injection part (7) separate from the removal part (8) for injecting an additive into a medical liquid by means of a needleless syringe, which first injection part (7) comprises an outwardly directed connection part (20) having a cavity (20A) for receiving a conical stem of the syringe and an inwardly directed closure part (26) in which a self-sealing septum (28) is arranged, with which the cavity (20A) of the first injection part (7) is closed, characterized in that:

the closure comprises a second injection part (6) which is separate from the first injection part (7) for injecting the additive into the medical fluid by means of a syringe with a needle, wherein the second injection part (6) comprises an inwardly directed closure part (16) which is provided with a recess (17) in which a self-sealing septum (18) is arranged, with which the recess (17) of the closure part (6) is closed.

2. The closure of claim 1, wherein: the closure comprises a cover part (2) and an edge part (3), wherein the cover part (2) comprises an inner section (4) and an outer section (5), the outer section (5) protruding outwards from the inner section.

3. A closure in accordance with claim 2, wherein: the first and second injection sections (6, 7) and the removal section (8) are arranged in a row side by side on the outer section (5) of the cover section (2).

4. A closure in accordance with claim 2, wherein: the first and second injection sections (6, 7) and the removal section (8) are arranged offset to each other on the outer section (5) of the cover (2).

5. A closure according to any of claims 1 to 4, wherein: the connecting portion (20) of the first injection portion (7) has an external thread (20B).

6. A closure according to any of claims 2 to 4, wherein: the connecting portion (20) of the first injection portion (7) is closed by a removal portion (21) which is connected to the connecting portion (20) of the first injection portion (7) via an annular fracture region (22).

7. The closure of claim 6, wherein: the removal part (21) of the connecting part (20) of the first injection part (7) has a lateral actuating web (25) which extends over the outer section (5) of the cover part (2).

8. A closure according to any of claims 2 to 4, wherein: the second injection site (6) has an outwardly directed annular collar (10) which is closed by a removal part (11) which is connected to the annular collar (10) of the second injection site (6) via an annular fracture zone (12).

9. The closure of claim 8, wherein: the removal part (11) of the second injection part (6) has a lateral actuating web (15) which extends over the outer section (5) of the cover part (2).

10. A closure according to any of claims 1 to 4, wherein: 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 removal part (8) has an inwardly projecting edge (19, 37) which clampingly secures a self-sealing diaphragm of the closure part of the first injection part or of the second injection part or of the removal part in the recess.

11. A closure according to any of claims 1 to 4, wherein: the recesses (16) of the first and second injection points (7, 6) each have a cylindrical first upper section (16A) and a cylindrical second lower section (16B) which is connected to the first upper section, wherein the diameter of the second lower section is greater than the diameter of the first upper section.

12. The closure in accordance with claim 11 in which: the self-sealing diaphragm (28) of the first filling part (7) has an annular lower section (28A) which is arranged in the second cylindrical section of the recess and a disk-shaped upper section (18C) which is connected to the annular section via an intermediate bridge (28B) and is arranged in the first cylindrical section.

13. A closure according to any of claims 1 to 4, wherein: the self-sealing septum (28) of the first injection part (7) has a basin-shaped recess (28D).

14. A closure according to any of claims 1 to 4, wherein: the self-sealing septum (36) of the removal part (8) has an outer annular upper section (36A) to which a disk-shaped lower section (36C) is connected via an intermediate bridge (36B), wherein the outer annular section of the septum is held in a clamped manner.

15. A closure according to any of claims 2 to 4, wherein: the connecting portion (29) of the removal portion (8) is closed by a removal portion (31) which is connected to the connecting portion (29) of the removal portion (8) via an annular breaking zone (32).

16. The closure of claim 15, wherein: the removal part (31) of the removal part (8) has a lateral actuating tab (33) which extends over the outer section (5) of the cover part (2).

17. A closure according to any of claims 1 to 4, wherein: the container is filled with infusion solution or injection solution or enteral nutrient solution.

18. A container comprising a closure according to any of claims 1 to 17.

19. The container of claim 18, wherein: the container is a bottle.