EP2194951B1 - Device for introducing medicine into an infusion container - Google Patents

Description

The invention relates to a device for adding a medicament to an infusion solution in an infusion container according to the preamble of claim 1.

A device of this kind is made US 5 647 845 A known, wherein on a cylindrical transfer cap on the outer circumference in the region of a transverse to the axis of the transfer cap inserted, rotatable valve body an angled pipe piece is attached, to which an infusion set can be connected. By means of the valve body rotatably arranged in the transfer cap, a connection can be established between the hollow mandrel attached to the transfer cap, which is inserted into the sealing area of an infusion container, and the angled tubular piece. At the exposed end of this pipe piece, contamination may occur during the handling of the device.

Before an infusion container with drip chamber is attached to carry out the infusion, it is known to mix the infusion solution, a drug such that on the removal opening of the infusion container, a transfer cap with a hollow dome for piercing the seal is placed on the infusion container, the a receiving device for a medicament container. After connecting the infusion container to the medicament container, infusion solution is first forced into the medicament container by repeatedly compressing the flexible infusion container. After dissolving and mixing the drug for solution for infusion, the assembly is rotated so that the infusion container at the bottom and the drug container is at the top, whereupon the contents of the drug container is sucked back into the infusion container by this again compressed and released several times. Thereafter, the drug container with transfer cap is removed from the infusion container and the infusion set attached to the infusion container, whereupon the infusion can begin.

This procedure is associated with the risk of contamination of the infusion solution, because after removal of the medicament container, the removal opening of the infusion container is exposed and contaminating ambient air can penetrate into the infusion container.

The invention has for its object to form a device of this kind so that the admixing of the drug for infusion without the risk of contamination.

This object is achieved by the features of claim 1. By not releasing the medicament container from the transfer cap after admixing the infusion solution drug and performing the infusion while the medicament container is in the infusion container, the system is kept closed to avoid the risk of contamination of the infusion solution.

Another advantage is a simplification of handling, because the drug container does not need to be removed from the infusion container. As a result, the staff can read at any time on the basis of the drug container, which drug was added to the infusion solution.

Fig. 1

in einer perspektivischen Ansicht den Infusionsbehälter mit Medikamentenbehälter und Tropfkammer im betriebsfertigen Zustand zum Ausführen einer Infusion,

Fig. 2

einen Schnitt durch die Vorrichtung mit einer Transferkappe nach einer ersten Ausführungsform,

Fig. 3

in der Schnittdarstellung nach Fig. 2 eine zweite Ausführungsform,

Fig. 4

in gleicher Darstellung eine dritte Ausführungsform,

Fig. 5

eine vierte Ausführungsform,

Fig. 6

perspektivische Darstellungen der Transferkappe,

Fig. 7

eine Ansicht des Infusionsbehälters,

Fig. 8

einen Längsschnitt durch eine abgewandelte Ausführungsform der Transferkappe, und

Fig. 9

eine perspektivische Ansicht der einzelnen Elemente der Ausführungsform nach Fig. 8.

The invention will be explained in more detail for example with reference to the drawing. Show it:

Fig. 1

in a perspective view of the infusion container with drug container and drip chamber in the ready state for performing an infusion,

Fig. 2

a section through the device with a transfer cap according to a first embodiment,

Fig. 3

in the sectional view to Fig. 2 a second embodiment,

Fig. 4

in the same representation, a third embodiment,

Fig. 5

a fourth embodiment,

Fig. 6

perspective views of the transfer cap,

Fig. 7

a view of the infusion container,

Fig. 8

a longitudinal section through a modified embodiment of the transfer cap, and

Fig. 9

a perspective view of the individual elements of the embodiment according to Fig. 8 ,

Fig. 1 shows a bottle-shaped infusion container 1, which usually consists of transparent plastic and flexible wall sections, so that the infusion container 1 can be compressed to generate a pressure in the container, whereupon by releasing a negative pressure is generated by the elastic side walls Reset. With 1.1 an eye for hanging the infusion container is called. On the lower side in the operating position of the infusion container is provided with a bottleneck 1.2, on which a transfer cap 2 is attached. 3 is a medicament container, usually a glass bottle, which is inserted with its axis oblique to the axis of the infusion container 1 in the transfer cap 2. 4 is a drip chamber of an infusion set, which is connected to the infusion container 1. Fig. 1 shows the operating position of the device in which an infusion is carried out, wherein the drip chamber 4 is arranged with its axis substantially parallel to the axis of the infusion container 1 or perpendicular and not oblique.

Fig. 2 shows in a section a first embodiment of the transfer cap 2 in the in Fig. 1 reproduced operating position. On the neck 1.2 of the infusion container 1, a sealing cap 1.3 is attached fluid-tight, which is provided with a pierceable seal area 1.4. On the bottleneck 1.2 with sealing cap 1.3, the transfer cap 2 via elastic latching sections 2.1 on a flange ( Fig. 1 ), which do not detachably overlap the edge of the sealing cap 1.3 without tools. To the in Fig. 2 Placed overhead flange with the catches 2.1 is followed by a substantially hollow cylindrical section 2.2 of the transfer cap, on the underside in Fig. 2 eccentrically a tubular approach 2.3 is formed so that its axis B is oblique to the axis A of the bottle neck 1.2 on the infusion container 1. This tubular approach 2.3 forms a receiving device for the drug container 3, which engages with its bottleneck 3.1 in this tubular approach 2.3. The tubular extension 2.3 is provided on its circumference with elastic hooks or notches 2.31, so that the provided with a flange or a crimp cap 3.1 of the medicine container 3 can engage in the tubular extension 2.3, whereupon the notches 2.31 the drug container 3 in the connecting position lock.

In the region of the tubular extension 2.3, the transfer cap 2 is provided on the side facing the infusion container 1 with a hollow mandrel 2.4, which pierces the sealing region 1.4 of the sealing cap 1.3, when the transfer cap 2 is attached to the bottle neck 1.2 of the infusion container 1. In the region of this hollow dome 2.4, a further hollow dome 2.5 is arranged on the transfer cap 2 such that it forms a seal 3.2 of the medicament container 3 pierces when the drug container 3 is inserted into the tubular neck 2.3.

Between the two hollow mandrels 2.4 and 2.5, a valve is arranged in the transfer cap 2, which interrupts the connection between the two hollow domes 2.4 and 2.5 and releases the connection only upon the action of an actuating force.

According to the first embodiment Fig. 2 the valve is designed as an elastic valve disc 5, which has three slots 5.1 in the middle region in a star shape. This valve disc 5 is clamped on the circumference between annular shoulders, wherein an annular shoulder is formed on a partition wall 2.7 of the transfer cap 2, on which the hollow mandrel 2.4 is formed, and the opposite annular shoulder is formed on the flange of an element provided with the hollow dome 2.5, as Separate component is used in this embodiment in the transfer cap 2 and in the region of the partition wall 2.7.

The transfer cap 2 is laterally adjacent to the off-center and obliquely attached tubular approach 2.3 with a recess 2.6 ( Fig. 1 ), through which the sealing area 1.4 of the sealing cap 1.3 is exposed, so that the infusion set can be inserted with a hollow dome 4.1 at the drip chamber 4 through this recess 2.6 perpendicular to the sealing area 1.4.

In this in Fig. 2 reproduced operating position infusion solution can flow from the infusion container 1 through the hollow dome 4.1 in the drip chamber 4, while the valve disc 5 keeps the connection between the infusion container 1 and drug container 3 is closed.

To admix a medicament for infusion solution, the transfer cap 2 with the tubular attachment 2.3 is first attached to the neck of the medicament container 3, so that the hollow mandrel 2.5 pierces the seal 3.2. In this case, the transfer cap 2 is connected to the medicament container 3 such that it can not be detached from the transfer cap 2 without a tool. Thereafter, the transfer cap 2 is attached to the sealed infusion container 1 with medicine container 3, so that the hollow mandrel 2.4 penetrates the seal area 1.4, as this Fig. 2a shows. In this case, the infusion container 1 may be positioned with the bottle neck on the top, so that the transfer cap 2 and the medicament container 3 are attached to the infusion container 1 from above. The closed valve 5 prevents it from leaking out of the medicament container 3.

Then the arrangement is 180 ° in the in Fig. 2a rotated position reproduced, which is pressed by repeated compression of the flexible walls of the infusion container 1 infusion solution in the drug container 3. By the force exerted on the infusion container 1 pressure, the valve disc 5 opens by bending between the slots 5.1 elastic valve lugs bend and allow a passage of infusion liquid to the drug container 3. After dissolution and mixing of the drug in the drug container 3, the arrangement is again rotated 180 ° in the in Fig. 2b rotated position reproduced, whereupon by repeated compression of the infusion container 1, the infusion solution admixed drug from the drug container 3 is sucked into the infusion container 1. In this case, the valve disc 5 opens by the negative pressure generated in the infusion container 1 after releasing the compressed side walls of the infusion container. 1

After the contents of the medicament container 3 is transferred into the infusion container 1, the hollow mandrel 4.1 of the drip chamber 4 is inserted through the recess 2.6 in the transfer cap 2 into the sealing area 1.4 of the infusion container 1, whereupon the infusion in the in Fig. 1 starting position reproduced. Here, the connection between the drug container 3 and infusion container 1 is interrupted by the valve disc 5, because no forces acting on the valve disc 5. It can thus flow back no infusion solution in the underlying drug container 3. The medicine container 3 is not detachably connected to the transfer cap 2 and remains in the in Fig. 1 and 2 reproduced position on the transfer cap 2, as long as the infusion is performed.

By remaining on the infusion device drug container 3 is immediately recognizable to the operator, which drug admixed to the infusion solution has been. Because the medicament container 3 is not released from the infusion container 1 or the transfer cap 2 after the mixing process, contamination in the connection area between the medicament container 3 and the infusion container 1 can not occur. After attaching the medicine container 3, the system remains closed.

The arranged in the transfer cap 2 valve between the obliquely arranged and separated hollow domes 2.4 and 2.5, which ensures that the medicament container 3 need not be removed, can be formed in various ways.

Fig. 3 shows a second embodiment with an actuatable by turning valve, wherein on the hollow mandrel 2.5, a valve disc 6 is formed, which is rotatably supported between detents on the partition wall 2.7 of the transfer cap 2 and eccentrically provided with a passage opening 6.1, with the mouth opening of the hollow dome 2.4 can be aligned. Fig. 3 shows the closed position of the valve disc 6, in which a closed area of the valve disc 6 of the mouth opening of the hollow dome 2.4 is opposite. Fig. 3a shows the connection position of the valve disc 6, in which the passage opening 6.1 is aligned with the hollow dome 2.4.

Thus, the valve disc 6 can be rotated with hollow mandrel 2.5 formed thereon, a positive connection between seal 3.2 and hollow mandrel 2.5 is expediently formed in that the hollow mandrel 2.5, for example, has an oval cross-section. As a result, by rotating the medicament container 3 in the tubular extension 2.3, the valve disc 6 can also be rotated into the open or closed position.

Fig. 4 shows a third embodiment with a displaceable in the axial direction of the tubular extension 2.3 valve element 7. In this embodiment, a neck 2.51 is formed on the hollow dome 2.5, which has a passage 2.52 ( Fig. 4a ), which can be closed and released by the displaceable valve element 7. Fig. 4 shows the closed position and the Fig. 4a the open position in which the sleeve-shaped valve element 7 is displaced in the direction of the medicament container 3, so that the passageway 2.52 is released.

Fig. 5 shows a fourth embodiment of the valve between the obliquely arranged hollow mandrels 2.4 and 2.5 in the transfer cap 2, which has a rotatable valve body 8 with a protruding on the transfer cap 2 knob 8.1. The shaft-shaped valve body 8 is rotatable in a transverse bore of a lug on the hollow mandrel 2.5 and provided with a passage opening 8.2, which can be aligned with the hollow mandrel 2.5 and a connection opening to the hollow mandrel 2.4, when the knob 8.1 is rotated in the marked by a mark 8.11 open position , Fig. 5a shows the open position.

In the described embodiments, the medicament container 3 is attached obliquely to the vertical in the operating position on the transfer cap 2, so that the flow path between the two hollow domes 2.4 and 2.5 can be kept as short as possible. But it is also possible to make the transfer cap 2 on the side of the medicament container 3 wider, so that the medicament container 3 can be positioned approximately perpendicular, ie with its axis B approximately parallel to the axis A of the infusion container 1. Although this results in a longer flow path between the two hollow domes 2.4 and 2.5 with the intermediate valve, but the flow path can be designed so that there is no interference with the mixing of the drug.

In such an embodiment, a valve element between the two hollow mandrels can be provided, which is transversely displaceable to the axes A, B of the infusion container 1 and the medicament container 3 for opening and closing the connection between the two containers in the transfer cap 2.

Fig. 6 shows the transfer cap 2 in various perspective views, wherein the hollow dome 2.5, which is formed on a separate component, which on the partition wall 2.7 (Fig. Fig. 6c ) is used in the Fig. 6b and 6c is not reproduced.

It is also possible to form the transfer cap 2 in two parts in such a way that the tubular projection 2.3 is slipped onto the hollow cylindrical section 2.2 by means of detents. As a result, the production can be simplified. Fig. 8 and 9 show such Two-part embodiment of the transfer cap 2, wherein at the bottom of the tubular neck 2.3 in Fig. 9 Recesses 2.32 are formed at diametrically opposite locations, the corresponding locking projections 2.33 record at the upper periphery of the hollow cylindrical sections 2.2 when the tubular projection 2.3 is attached to the section 2.2.

According to this embodiment Fig. 8 and 9 are the hollow domes 2.4 and 2.5 formed on the two elements 2.2 and 2.3 of the transfer cap 2, as this Fig. 8 shows. The hollow mandrel 2.5 is formed on a partition wall 2.51 in the tubular extension 2.3 in such a way that a chamber 2.52 results between the hollow dome 2.5 and the valve 5. At the in Fig. 8 2.34 designated edge portion of the tubular extension 2.3 are in Fig. 9 reproduced recesses 2.32 formed.

At the hollow cylindrical portion 2.2 of the hollow dome 2.4 is formed in a corresponding manner on the partition wall 2.7, as well as Fig. 2 shows, with the adjoining the valve 5 chamber 2.71 in Fig. 8 is larger than in Fig. 2 ,

The valve in the form of the valve disc 5 is clamped between the two elements 2.2 and 2.3 between the partitions 2.7 and 2.51.

In the embodiment of the Fig. 8 and 9 are the in Fig. 2 reproduced notches 2.31 for receiving the medicament container 3 as a latching hook at opposite locations on the circumference of the tubular extension 2.3 formed as Fig. 9 shows. At the hollow cylindrical section 2.2 are instead of the opposite latching sections 2.1 in Fig. 6b in the Fig. 8 and 9 adjacent latching sections formed so that a total of four locking sections 2.1 result.

An embodiment is also possible in which the two hollow domes 2.4 and 2.5 are integrally formed on the transfer cap 2 or on its partition wall 2.7, wherein the valve mechanism can be inserted laterally between the two hollow domes, similar to the one in FIG Fig. 5 reproduced design.

The sealing area 1.4 at the removal opening of the infusion container 1 can be designed such that two adjacent sealing openings 1.41 and 1.42 are present in the cap 1.3, one of which is for the hollow dome 2.4 of the transfer cap 2 and the other for the hollow dome 4.1 of the drip chamber 4th is provided. Fig. 7 shows such a shaped, approximately rectangular sealing area 1.4 on the infusion container 1, wherein the border of the rectangular portion 1.4 is part of the sealing cap 1.3.

In such an embodiment of the sealing region, an alignment device can be integrally formed on the transfer cap 2, by means of which the transfer cap 2 can only be attached to the infusion container 1 or to the sealing cap 1.3, that one of the openings 1.41, 1.42 under the recess 2.6 and the other is located under the hollow dome 2.4 of the transfer cap. In this way, incorrect positioning of the transfer cap 2 on the sealing cap 1.3 is prevented.

In the described embodiments, the medicament container 3 and the drip chamber 4 are arranged so that they lie with their axes substantially in one plane, as this Fig. 1 shows. It is also an embodiment possible in which the medicament container 3 and thus also the tubular approach 2.3 obliquely to the plane in Fig. 1 is arranged so that in a side view from right or left in Fig. 2 the medicament container 3 obliquely to the drip chamber 4 and obliquely to the plane in Fig. 2 lies.

Claims (10)

1. Device for adding a medicine to an infusion solution in an infusion container (1), whose removal opening is provided with a seal area (1 4), comprising a cylindrical transfer cap (2),
   which can be connected to the removal opening of the infusion container (1) and has a hollow spike (24) for piercing the seal area (1.4),
   wherein a hollow cylindrical receiving means (2 3) for a medicine container (3) is formed at the cylindrical transfer cap (2) and has a hollow spike (2.5) for piercing a seal (3 2) at the medicine container (3),
   a valve (5; 6; 7; 8) arranged between the two hollow spikes (2.4, 2.5) in the transfer cap (2),
   wherein the valve interrupts the connection between the two hollow spikes (2 4, 2.5) and can be moved into the open position only by the action of a force, and
   wherein a free area (2.6) is formed at the transfer cap (2) for attaching an infusion set, characterized in that
   the hollow cylindrical receiving means (2 3) is arranged excentrically at the cylindrical transfer cap (2), wherein laterally adjacent the excentrically arranged hollow cylindrical receiving means (2.3), a recess (2 6) is formed at the transfer cap, into which the infusion set with a hollow spike (4.1) can be inserted by piercing vertically into the seal area (1 4) of the infusion container
2. Device according to claim 1, wherein the hollow cylindrical receiving means (2 3) is positioned with its axis (B) inclined to the axis (A) of the transfer cap (2), such that a medicine container (3) inserted in the receiving means (2.3) is arranged inclined to the axis (A) of the receiving means (2 3)
3. Device according to claim 1 or 2, wherein the receiving means (2 3) for the medicine container (3) has a non-releasable connecting means
4. Device according to one of claims 1 to 3, wherein the transfer cap (2) is formed in two parts and has a tubular hub (2.3) as a receiving means for the medicine container (3) and a hollow cylindrical portion (2.2) which via a locking means (2.32, 2.33) can be connected to the tubular hub (2.3) at which the hollow spike (2.5) is moulded on
5. Device according to one of the preceding claims, wherein the valve is formed as a resilient valve disc (5) between the hollow spikes (2.4, 2.5) and provided with at least one slit which can be opened by pressure or low pressure
6. Device according to one of claims 1 to 4, wherein the valve has a rotatable valve disc (6) which is provided with a passage opening (6 1), which by rotating can be aligned with the hollow spikes (2.4, 2.5) located opposite each other.
7. Device according to one of claims 1 to 4, wherein the valve has a member (7) which is displaceable in the axial direction of the connection between the hollow spikes (2.4, 2.5) and by means of which a through-channel (2.52) can be sealed and unblocked
8. Device according to one of claims 1 to 4, wherein the valve has a valve body (8) having a passage opening, the valve body being rotatable by an adjusting knob (8.1) and being arranged between the hollow spikes (2 4, 2 5) located opposite each other in the transfer cap (2).
9. Device according to one of claims 1 to 3 and 5 to 8, wherein the hollow spike (2.5) provided for the medicine container (3) is inserted into the transfer cap (2) as a separate component part.
10. Device according to claim 9, wherein at least members of the valve are moulded on or attached at the hollow spike (2.5)

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