Connector for packaging containing medical fluids and packaging for medical fluids

The present invention relates to an adapter for medical fluid packages, in particular for infusion or transfusion bags, which serves to withdraw fluid from the bag. The invention also relates to a self-sealing membrane for use at the outlet of an outlet for medical fluid packages. The invention furthermore relates to the use of such a connector.

WO 96/23545 describes an infusion bag with an injection connector and a receiving connector. The drug is supplied through the injection fitting by means of an injection syringe. This connector consists of a tubular connector which is closed with a protective cap shaped as a break off part. A self-sealing septum (Septum) is seated in the opening zone of the connector, and a pierced diaphragm is disposed in the connector so that the septum does not come into contact with the fluid prior to use of the infusion bag. Fluid is drawn through the receiving connector using a spike. The fitting does not have a self-sealing septum and is otherwise structured like an injection fitting.

An infusion fluid collection adapter is also described in DE 197 28 775 C2. The tubular connector of the known receiving connector is closed by a flat diaphragm that is one piece with the connector.

Furthermore, DE 10030474 C1 discloses an adapter for packages for medical liquids and a package such as infusion or transfusion bags. This known connector has a tubular connector that is closed by a self-sealing diaphragm. In order to attach the adapter to the fluid withdrawal needle, in this known solution, two wings are provided which protrude from the tubular connection piece. These wings fit into the slots provided on this needle adapter. The wings are resilient against said socket.

The known receiver switches have proven themselves in practice. However, their disadvantage is that the infusion bag is no longer properly closed after the spike has been pulled out. Thus, there is a risk of infusion fluid leakage, which must be taken into account especially after the admixture of cytostatic agents.

A further disadvantage is that the connection between the spike and the receiving connector is not slip-proof. When the bag is hanging on a tripod, there is a danger that the spike connection with the receiving connector may become disconnected by inadvertently pulling on the hose.

Another disadvantage is that the punctured diaphragm which closes the nipple of the receiving coupler does not always withstand the increased mechanical stress. Impact tests have shown that the diaphragm tears at some load connectors.

The invention is based on the object of creating an adapter for packages for medical fluids, in particular for infusion or transfusion bags, which reliably seals the package when the spike is pulled out.

The connector according to the invention for packages for medical fluids, in particular for infusion or transfusion bags, with a tubular connector for attaching a fluid withdrawal spike, the connector having a lower outlet opening on the packaging side and an upper outlet opening on the connection side, and a tear-off closure cap that closes the outlet opening of the coupling on the connection side, the coupling has a self-sealing membrane pierced with a spike for fluid intake, wherein the self-sealing diaphragm has an upper annular part which passes into a lower disc-shaped part to form a recess, the upper annular part of the diaphragm in the punctured condition of the cup-shaped part constituting a sealing element for the spike, the self-sealing diaphragm being clamped with elastic deformation between the lower segment and the upper segment of the tubular coupling is characterized by that the upper annular portion of the self-sealing diaphragm is surrounded by an outer T-shaped annular portion, the outer annular portion being clamped between the lower segment and the upper segment of the tubular coupling.

The connector of the invention has a self-sealing diaphragm which is positioned in the connector to attach the fluid extraction spike. This self-sealing membrane prevents liquid from escaping from the package when the spike is retracted.

An advantage is that the self-sealing diaphragm has an annular portion that transitions into the discoidal portion, the annular diaphragm portion sealingly surrounding the spike when piercing the discoidal portion.

The special design of the diaphragm with an annular and plate-like part ensures, on the one hand, good guidance of the spike when piercing the diaphragm and, on the other hand, guarantees that the diaphragm is tight again after the spike is pulled out, even at relatively high pressure inside the package. Tests have shown that the special configuration of the diaphragm is decisive for the immediate closure of the outlet, this sealing of the diaphragm being improved with increasing internal pressure in the package. This reliable seal is not due to the volume of the material but to the special geometry of the diaphragm.

In a preferred embodiment of the connector according to the invention, the material of the disc-shaped part of the self-sealing membrane is weakened, which makes it easier to pierce the membrane with a spike. Preferably, the material of the self-sealing diaphragm has a pre-cut cross cut, but the cut could also be star-shaped or just a straight slit.

In a particularly preferred embodiment, the lower segment and the upper segment of the tubular coupling are snap-fitted. The self-sealing elastically deformed diaphragm is clamped between this lower and upper segment. As a result, the connector can be easily assembled by pressing the individual parts together. But it is also possible to weld and / or glue parts of it together.

In a further particularly advantageous embodiment, it is provided that an outer part is connected to the annular part of the diaphragm, which is fastened between the above-mentioned two segments.

A second pierceable membrane is preferably disposed in the connector below the self-sealing membrane to form a separation chamber so that the self-sealing membrane in the tubular connector does not come into contact with the solution contained in the infusion or transfusion bag prior to its use. The pierced second membrane is preferably one piece with the coupling piece.

Research has shown that the use of an upward or downward curved diaphragm instead of a flat diaphragm contributes to increased shock resistance. Preferably the second membrane is bulged upwards or downwards so that the connector according to the invention withstands relatively high mechanical loads. In addition to increasing the impact resistance, it is also advantageous that the spike in the piercing position is crimped by the beaded diaphragm, so that the spike is better fixed in the pick-up position and does not accidentally slip.

In order to prevent the upper and lower segments of the connector from radial twisting, both of these parts may have a toothing or a similar configuration which also ensures that these parts are accurately positioned during interference fit. In addition, this significantly reduces the risk of damage to both membranes when the individual segments are joined in this way.

The breakaway cap of the connector, which serves as its original closure, is preferably connected to the connector via an annular fracture zone.

The breakaway closure cap preferably has a handle shaped like an upward arrow, so that it is immediately apparent that it is a receiving fitting and not an injection fitting. Preferably the arrow is a recess in the handle which allows it to be recognized immediately without the need for labeling or similar means. This avoids confusing the receiving connector with the injection connector when it comes to packaging for fluids used in medicine.

Also, the lower segment of the connector has preferably an upward pointing arrow which is shaped as a convex structure, preferably in the grip socket. This arrow on the underside of the coupler allows this receiving coupler to be clearly identified, even after breaking off the closure cap.

The self-sealing membrane according to the invention for use at the extraction point for packaging for medical fluids, having an inner disc-shaped part which can be penetrated by the tubular extraction device, an outer annular part for securing the membrane at the extraction point and an inwardly upper annular part which connects the outer annular part the part with a plate part is characterized by the fact that that the outer annular portion of the self-sealing membrane is T-shaped for clamping between the lower segment and the upper segment of the tubular coupling of the container connector.

Preferably, the inner diameter of the inside upper annular portion decreases towards the discoidal portion, the internally top annular portion and the discoidal portion form a trough-shaped recess and the internally top annular portion tightly surrounds the tubular extraction device for penetration of the discoidal portion.

Preferably, the surface of the inside upper annular portion extending obliquely towards the inside and facing the withdrawal device consists of two portions.

With a different slope, the upper sloped portion having a smaller slope than the lower sloping portion.

Preferably, the material of the inner plate portion is weakened, preferably scored.

The connector according to the invention is used in a package for fluids used in medicine, in particular in an infusion or transfusion bag.

The subject of the invention is illustrated in the drawing in which Fig. 1 shows a cross-section of a medical fluid package connector configured as a receiving connector; Fig. 2 shows the infusion bag with the receiving connector of Fig. 1 and the injection connector; and Fig. 3 shows the injection connector of the infusion bag of Fig. 2 in section.

The connector designed as a receiving connector 20 and intended for packages for medical fluids, in particular for infusion or transfusion bags, has a tubular connector 1 which consists of a lower segment 2 on the packaging side and an upper segment 3 on the connector side. Thus, the tubular coupling 1 has a lower and upper outlet 1a, 1b. The receiving connector 20 is a polypropylene molding.

The lower segment 2 of the tubular connector 1 has a lower cylindrical part 4 which passes into the upper neck section 5. The cylindrical part 4 of the lower segment 2 can be inserted into the connection socket of the foil bag and is welded or glued to this connection or is welded directly to the foil bag without nipple. The cylindrical part 4 at its upper end is closed by a pierceable diaphragm 6, which is one piece with the lower segment 2. The injected diaphragm is bulged downwards, but alternatively the membrane may also be bulged upwards.

The upper segment 3 of the tubular coupling 1 is snapped onto the lower segment 2, the upper segment 3 having a cylindrical portion 7 which encircle the upper segment 3. The inner wall of the cylindrical portion 7 of the upper segment 3 has a circumferential groove 8 into which the circumferential projection 9 snaps into on the outer wall of the neck section 5 of the lower segment 2 by pressing-fit connection of both segments 2, 3.

Between the lower and upper segments 2, 3 of the coupling 1, a self-sealing membrane 10 of elastic material, also referred to as "septum", is clamped with an elastic deformation. The self-sealing diaphragm 10 has an outer annular portion 11 which is clamped between the lower and upper segments 2, 3 of the tubular coupling 1. An upper annular part 12 connects to the outer annular part 11, which, by forming a hollow recess 13, passes on the side of the upper self-sealing membrane 10 into a lower plate part 14. In the center, the disk part 14 has a cross or star-shaped notch, so that the elastic material is weakened. but not cut.

The upper segment 3 of the tubular coupling 1 is connected through the annular fracture zone 31 to the cap 16, which closes the upper outlet 1a of the coupling 1. The closing cap 16 passes into a flattened handle 17, which has a hollow 18 in the shape of an upward arrow 19. After in the direction of the arrow, it is immediately apparent that the connector is not an injection connector 40 but a receiving connector 20.

Fig. 2 shows a side view of the receiving connector 20 of Fig. 1. Fig. 2 shows a solution-filled infusion bag 1A that has a receiving connector 20 for withdrawing the infusion solution and a further injection connector 40 for injecting this solution into the infusion bag 1A.

On the outer wall of the cylindrical portion 7 of the upper segment 3, the tubular nipple 1 of the receiving connector 20 has two opposing gripping sockets 21, each of which is formed by protruding ribs 22 spaced apart from each other. A further arrow 23 is bulged between the ribs 22 on the outer wall of the cylindrical portion 7, which also points upwards so that this connector can be recognized as a receiving connector 20.

The infusion bag 1A is made of two layers of foil 24, which are welded together on the lower and upper rims 25, 26 and on the longitudinal rims 27, 28. On the upper rim 26 of the infusion bag, two connection sockets 29, 30 are welded together. the connectors of the injection connector 40 and the receiving connector 20 are inserted into these connection pipes 29, 30 and are connected to the connector pipe during sterilization. However, the tubular couplings of the original closures can also be shaped as a shuttle or a circular insert that is welded between two layers of foil.

Fig. 3 is a sectional view of the injection connector 40 of the foil infusion bag 1A. The injection connector 40 is similar in structure to the receiving connector 20, so corresponding elements are indicated with the same reference numerals. The injection fitting 40 has a tubular fitting 1 'that is composed of a lower and an upper segment 2', 3 '. Both these segments 2 ', 3' are snap-fitted and between them

There is a self-sealing diaphragm 10 ', the projection 8' of the lower segment 2 'engaging the groove 9' of the upper segment 3. In the lower segment 2 'there is an injected flat diaphragm 6' which may also be bulged.

The upper segment 3 'of the tube coupling 1' is again connected via an annular fracture zone 31 'to a breakaway closure cap 16' which transforms into a flattened handle 17 '. A downward pointing arrow 19 'is hollowed out on this handle 17'. On the outer wall of the upper segment 3 'there are again, within the grip seats 21', downward arrows 23 'indicating the direction of flow.

In order to withdraw the infusion solution, the closing cap 16 of the receiving connector 20 has to be torn off by twisting or breaking, which makes the self-sealing diaphragm available.

10. The spike of the known shunting system is inserted into the tubular nipple 1 of the receiving fitting, whereby the pre-cut self-sealing membrane 10 and the diaphragm diaphragm 6 are punctured. Due to the special design of the injection-molded diaphragm 6, the spike is held securely in the tubular coupling 1.

The infusion solution can then be withdrawn. After the spike has been pulled out, the self-sealing diaphragm 10 reliably seals the receiving fitting 20 again reliably, even at relatively high internal pressures. Moreover, this special configuration of the diaphragm 6 increases the mechanical strength of the receiving connector 20.

The injection connector 40 enables the active ingredient to be injected into the infusion solution. To this end, after removing the break-off cap 16 ', the self-sealing diaphragm 10' and the diaphragm 6 'are punctured with the injection needle of the syringe. When the needle is pulled out, the injection fitting tightens again.