HK1138551B - Closure cap for a container for receiving fluids, particularly an enteral nutrient solution and container having such a closure cap - Google Patents

Description

The invention relates to a system incorporating a spike and a cap for a fluid receptacle, in particular a fluid receptacle for enteral nutrition, which has a lid and a rim; in addition, the invention relates to a fluid receptacle for enteral nutrition, in particular a BFS receptacle, with such a system.

The Blow-Fill Seal (BFS) process is a process whereby containers, such as bottles made of extruded PE or PP, are blown into a desired shape in a process that is sterile and pyrogen-free and are aseptically filled and hermetically sealed with a sterile filler immediately after cooling.

If the known BFS containers are used to receive sterile medical fluids, such as enteric nutrient solutions, the containers shall require a cap-locking system to allow the enteral nutrient solution to be transferred to the patient by means of a transfer device.

For the provision of enteral nutrient solutions, nutrient bags are known to have a connecting part, also known as a port, to which a conductor can be connected to supply the nutrient solution to the patient.

The known devices for the delivery of the enteral nutritional solution to the patient have a tube at one end with a spike which can be connected to the connecting part of the nutritional solution bag.

The known connecting parts of the known nutrient bags are tightly closed by a membrane which is pierced by the spike of the transducer when the hose is connected.

From DE 20 2004 003 267 UI, a closing cap for a BFS container is known, which has a lid and a rim, in which a slit membrane is used to allow the spike of a transducer to be filled.

DE 198 58 237 A1 describes a system of a kind with an adapter for enteral overhead systems. It has a base part which is formed as a screw cap. The base part's opening for a liquid to be administered to the patient is closed by a slit glass of flexible material. This glass valve opens when a spike is inserted. At one upper edge of the adapter there is a reception device for the safe reception of the spike.

The purpose of the invention is to provide a system comprising a spike and a cap for a container for taking up fluids, in particular a BFS container for taking up an enteral nutrient solution, which simplifies the handling of the container when connecting the spike to a hose line of a transmission device.

The solution of these problems is based on the features of the invention as stated in claims 1 and 13.

The cap for a container for the intake of liquids, in particular a BFS container for the intake of an enteric nutrient solution, which is part of the system of the invention, has a lid and a rim, in which the lid is located a drainage part for the intake of a liquid, in particular the enteric nutrient solution.

The removal part of the cap shall have a connection for a spike of a hose line of a transducer and a closure part with a perforating membrane to close the removal of the connection part.

The closing cap is characterised by the fact that the extraction part has a reception piece for the spike, which is formed as a ring-shaped body closely surrounding the spike, which is connected to the upper edge of the connecting part and extends inwards into the edge of the closing cap. This ensures that when the membrane is connected with the spike, the closing cap is tightly closed. If the spike is connected to the closing cap, the closing cap is closed tightly by the membrane, but when the membrane is connected there is a risk that the membrane does not escape from the spike. The ring-shaped body closely surrounding the spike then ensures that no nutrient release from the closing cap is released.

The ring-shaped body closely enclosing the spike is connected to the upper edge of the spike by forming a narrow gap between the inner wall of the connecting part and the outer wall of the ring-shaped body. This allows the ring-shaped body to deform easily when the spike is introduced, so that the spike is closely enclosed by the body. The wall thickness of the ring-shaped body is measured or the material from which the ring-shaped body is made up is selected in such a way that a certain elasticity is given to the ring-shaped body.

In a preferred embodiment, the ring-shaped body closely enclosing the spike has a non-round, in particular a substantially rectangular cross-section, so that the spike, which also has a rectangular cross-section, is held torsion-proof in the ring-shaped body.

The connection section is essentially cylindrical and extends outwards from the cover of the cap, the ring-shaped body, which closely encloses the spike, is connected to the upper edge of the cylindrical section of the connection section, the ring-shaped body extending inwards from the cover of the cap.

Another preferred embodiment is the use of an external screw for the essentially cylindrical section of the connecting part, which allows a spike with a screw cap to be securely bolted to the closing cap to prevent the spike from slipping out.

For aseptic closure of the puncture membrane, the connecting part is preferably closed with a break-off part called the original part, connected via a ring-breaking zone at the top of the connecting part.

To improve handling, the cut-off part preferably has handles protruding from the closing part on the side, preferably connected to a central plate-shaped section of the cut-off part.

The handles shall preferably extend to the lid part of the cap, leaving only a narrow gap between the bottom edge of the handles and the lid part, which prevents the tube conductor of the transmission from becoming stuck between the handles and the cap.

In another particularly preferred embodiment, the closing part has a essentially cylindrical section extending inwards from the cover part of the closing cap.

The essentially cylindrical section of the closing part is formed in another particularly preferred embodiment as a border edge over the permeable membrane, which tightly locks the membrane in the exclusion of the closing part. This simplifies the manufacture of the closing cap. First the membrane is inserted into the cylindrical section of the closing part, the edge of which is then rounded.

However, it is also possible to use the perforated membrane in the cylindrical section of the closing part and/or to pinch it radially.

The cap of the system of the invention can be manufactured in large quantities inexpensively as a single injection moulded plastic component.

The container of the invention has the system of the invention described above Preferably, the container is formed as a bottle, in particular a BFS bottle, with the cap closely attached to the container, which may be glued and/or welded to the container or formed as a screw cap.

An example of the implementation of the invention is explained below with reference to the drawings.

It shows: Fig. 1 an example of the closing cap closed with the cut-off in the side view,Fig. 2 the closing cap of Fig. 1 in the side view, with the cut-off broken and the spike of a hose conduit of a transducer screwed with the closing cap,Fig. 3 a cut through the closing cap of Fig. 2 along the line A-A,Fig. 4 a cut through the closing cap of Fig. 2 along the line C-C,Fig. 5the closing cap of Fig. 2 in perspective andFig. 6 an example of a containment device with the closing cap.

Figure 1 shows the closing cap 1, in the side view, which is tightly closed by a break-off section 2. The closing cap 1 has a cover section 3 and a rim section 4. The cover section 3 has an outer section 3A to which an inner section 3C is connected via an outwardly curved section 3B. The inner section 3C of the cover section 3 is equipped with a sampling section 5 to allow the extraction of a liquid, in particular an enteric nutrient solution. The nutrient solution is taken with a spike not shown in Figure 1 which is connected to the closing cap after the break-off of the break-off section 2.

The closing cap is described in detail below with reference to Figures 2 to 5, with the spike 6 connected to one end of a non-shown hose line of a non-shown transformer being screwed with the closing cap.

The extraction part 5 for enteral nutrient extraction has a connecting part 7 and a closing part 8. The extraction part 7 has a essentially cylindrical section 9 extending outwards from the inner section 3C of the lid part 3. At the upper edge of the cylindrical section 9 there is a ring body 10 which extends inwards. The ring body 10 has a substantially square cross-section corresponding to the cross-section of the spike 6. The ring body 10 which closely encloses the spike is at the upper edges of the cylindrical section 9 of the shape so that the inside of the cylindrical section 9 and the inside of the body 10 are transformed into a cleft 18 times the size of the spike.

The closure section 8 of the cap 1 has a substantially cylindrical section 11 extending inwards from the inside of the inner section 3C of the cover section 3. In the exception 12 of the cylindrical section 11 of the closure section 8 there is a perforating membrane 13. The self-sealing membrane 13 has an outer ring section 13A and an inner section 13B which has a moulded recess 13C and is slit.

When mounted, after insertion of diaphragm 13 into cylindrical section 11, its lower edge 11A is wrapped around so that the lower edge 11A underlies diaphragm 13 and the outer section 13A of diaphragm 13 is held in the exclusion 12 of closure 8.

The rim 4 of the cap 1 has a lower, wooden rim 14 with a circular groove 15 at the bottom.

The cap 1 is bolted to the spike 6 and the spike 6 has an unbreakable secure overhead contact 6A with an inner screw 6B, while the outer wall of the cylindrical section 9 of the connector part 7 has a corresponding outer screw 9A so that the overhead contact 6A can be bolted to the connector part 7 of the cap 1.

The cap 1 is sealed not only by membrane 13 but also by the ring-shaped section 10 which tightly encloses the spike 6 ensuring that enteral nutrient solution cannot escape even when the spike is introduced into the cap withdrawal.

Before the enteral nutrient solution is withdrawn, the cap 1 is tightly closed with the cut-off part 2 (Fig. 1). The cut-off part 2 has an inner plate-shaped section 2A connected by a ring-breaking zone 19 to the upper edge of the cylindrical section 9 of the cut-off part 7. At the inner plate-shaped section 2A of the cut-off part 2 two 2C body handles are connected by narrow steps 2B, protruding on either side. The handles 2C are flat, the width of which corresponds to the width of the outer section 3A of the cut-off part 3. The upper 2C handles extend to the outer section 3A of the cut-off part 3, with the handles 2C and 2C being widely spaced between the edges of the cut-off part, giving the shape of a 3D outer spindle, which is approximately the same as the outer part of the cut-off cap.

Figure 6 shows the cap of the system of the invention together with a container of the invention, which in the present example is a BFS bottle. Cap 1 is fixed on the bottle neck 16 of bottle 17 filled with an enteric nutrient solution. Cap 1 is welded with the neck 16 of the bottle, with the upper edge 16A of the bottle neck reaching into the nut 15 of the winding edge 14 of the cap.

Claims (13)

1. System comprising a spike and a closure cap for a container for holding liquids, in particular a container for holding a liquid for enteral nutrition, having a cover part (3) and an edge part (4), wherein the cover part (3) has a withdrawal part (5) having a recess (12) for withdrawing a liquid, said withdrawal part (5) having a connector part (7) having a holding piece (10) for holding the spike of a tube line of a transfer device, and the withdrawal part (5) has a closure part (8) having a pierceable membrane (13) for closing the recess (12) in the withdrawal part (5), wherein the closure part (7) has a substantially cylindrical portion (9) which extends outwardly from the cover part (3), wherein the holding piece (10) is integrally formed on the upper edge of the substantially cylindrical portion (9) of the closure part (7) and extends inwardly into the connector part, wherein the holding piece for the spike is in the form of an annular body (10) that encloses the spike, wherein the annular body (10) that encloses the spike is connected in such a way to the upper edge of the substantially cylindrical portion (9) of the connector part (7) and extends in such a way inwardly into the connector part that when the pierceable membrane (13) is pierced the annular body (10) encloses the spike for closing the recess (12) in the withdrawal part (5), wherein the annular body (10) that encloses the spike is integrally formed on the upper edge of the connector part, forming a narrow gap (18) between the inner wall of the connector part (7) and the outer wall of the holding piece, characterized in that the closure cap is sealed off not only by the membrane (13) but also by the annular body (10) that tightly encloses the spike, when the spike has been introduced into the withdrawal part (5) of the closure cap, and in that the wall thickness of the annular body is dimensioned such that the annular body is given a certain elasticity, such that the annular body deforms slightly when the spike is introduced, such that the spike is enclosed tightly by the body.
2. System according to Claim 1, characterized in that the annular body (10) that tightly encloses the spike has a cross section in the form of a circular ring.
3. System according to Claim 1, characterized in that the annular body (10) that tightly encloses the spike has a non-round cross section.
4. System according to Claim 3, characterized in that the annular body (10) that tightly encloses the spike has a substantially rectangular cross section.
5. System according to one of Claims 1 to 4, characterized in that the substantially cylindrical portion (9) of the connector part (7) is provided with an external thread (9A).
6. System according to one of Claims 1 to 5, characterized in that the connector part (7) is closed off with a break-off part or twist-off part (2) which is connected to the upper edge of the connector part via an annular break zone (19).
7. System according to Claim 6, characterized in that the break-off part (2) has a central plate-like portion (2A) to which there are connected gripping tabs (2C) that protrude laterally from the plate-like portion (2A).
8. System according to Claim 7, characterized in that the gripping tabs (2C) extend as far as the cover part (3) of the closure cap.
9. System according to one of Claims 1 to 8, characterized in that the closure part (8) has a substantially cylindrical portion (11) which extends inwardly from the cover part (3), wherein the pierceable membrane (13) sits in the cylindrical portion (11) of the closure part (8).
10. System according to Claim 9, characterized in that the lower edge of the substantially cylindrical portion (11) of the closure part (8) is in the form of a flanged edge (11A) that engages over the pierceable membrane (13).
11. System according to Claim 9 or 10, characterized in that the cover part (3) has an outer portion (3A) which is adjoined by an inner portion (3C) via an outwardly curved portion (3B), wherein the substantially cylindrical portion (11) of the closure part (8) is connected to the inner portion (3C) of the cover part (3).
12. System according to one of Claims 1 to 11, characterized in that the closure cap (1) is a one-piece injection-moulded part.
13. Container, in particular a BFS bottle, having a system according to one of Claims 1 to 12.