The invention relates to a connector system for attaching a withdrawal device to a container for a medical liquid according to the preamble of claim 1, and also to a container for a medical liquid, with such a connector system, according to the preamble of claim 14.
EP 0 534 136 B1 discloses a film bag which is filled with a medical solution and has a connector for withdrawal purposes and a filling nozzle. The contents of the European patent mentioned are fully incorporated into the present patent application by reference.
However, the configuration of the connector for withdrawal purposes restricts the choice of an appropriate withdrawal device. In particular in the case of rinsing solutions which are used in different medical areas, this may be disadvantageous since the same withdrawal devices are not customary or available in all areas.
The invention is based on the problem of specifying a connector system of the type mentioned at the beginning and also a container for a medical liquid, which are versatile.
This problem is solved in respect of the connector system by the features of claim 1. It is a connector system for attaching a or at least one withdrawal device, preferably two withdrawal devices, to a container for a medical liquid, in particular for a medical rinsing solution. The connector system comprises a first withdrawal port and a second withdrawal port, which are each designed for withdrawing the medical liquid from the container: the first withdrawal port and the second withdrawal port are each closed by a reclosable membrane and a break-off cap as a tamper-evident closure. In addition, the first withdrawal port and the second withdrawal port are of different designs. This has the advantage that the user no longer needs to modify the withdrawal port in order to be able to use it with the withdrawal devices available to him. It is also no longer necessary to keep rinsing solution containers with different withdrawal ports ready. In addition, the ports can be provided in a sterile state.
When used as intended, a connector system of the abovementioned type closes off an in particular sterile container containing a medical liquid and permits the production of a fluid connection between the container containing the medical liquid and a withdrawal device. To produce the fluid connection, that is to say to be able to withdraw medical liquid from the container, according to the invention the first withdrawal port and the second withdrawal port are provided. The connector system can be suitable as a medical connector system, in particular for the sterile connection of an infusion or dialysis bag or of a rinsing solution bag as containers, on the one hand, and of a transfer device or other medical assemblies as withdrawal device, on the other hand.
In particular, the first withdrawal port and the second withdrawal port can be of different designs such that they can receive a withdrawal device with in each case different flow rates and/or different attachments. The first withdrawal port and/or the first withdrawal device are preferably designed in such a manner that a greater flow rate in comparison to the second withdrawal port and/or the second withdrawal device can be provided. The first withdrawal device and the second withdrawal device can also be attached at the same time to the container.
In an embodiment, the first withdrawal port is designed to receive a first withdrawal device with a cylinder attachment, and/or the second withdrawal port is designed to receive a second withdrawal device with a spike attachment. The first and/or the second withdrawal device can comprise a drip chamber and/or a flexible tube of a transfer system. The cylinder attachment of the first withdrawal device can also be referred to as a tubular attachment. The cylinder attachment system is preferably provided with a thread in order to prevent an unintentional release from the connector system.
The cylinder attachment comprises at least one substantially cylindrical tubular portion which can be inserted into the first withdrawal port. At the latest when fully inserted, the cylinder attachment opens the membrane. The cylinder attachment preferably does not have a point, for example in contrast to a spike attachment. The end surfaces of the cylinder attachment, which press against the membrane, are arranged substantially transversely, preferably perpendicularly, with respect to the longitudinal axis of the cylinder attachment. The end surfaces can have a cut in order to assist the opening of the membrane. In a further refinement, the front portion of the cylinder attachment, in particular additionally, can be conical at least in part. However, the cylinder attachment as such does not have any oblique cut. The cylinder attachment is preferably an attachment of the care-lock type.
In a refinement, the first withdrawal port has an outer thread. By means of the cylinder attachment of the first withdrawal device being screwed on, said cylinder attachment can be connected to the first withdrawal port and a fluid connection can be produced by opening the membrane. In a further refinement, the second withdrawal port can be connected to the second withdrawal device by means of the spike attachment of the second withdrawal device being pushed into the membrane of the second withdrawal port, and a fluid connection can be produced by opening the membrane.
The first withdrawal port and the second withdrawal port of the connector system customarily each have a channel for producing a fluid connection between the container and the withdrawal device. The channel of the second withdrawal port can have in part a larger internal diameter than the channel of the first withdrawal port, in order to be able to provide a different flow rate in relation to the first withdrawal port. In addition, the channel of the first withdrawal port can be longer than the channel of the second withdrawal port. In an embodiment, the channel of the second withdrawal port has a cross section tapering in the direction of the container. The channel of the second withdrawal port is preferably of such a length that the insert spike of the second withdrawal device, in the fully inserted state, extends at least half way along the channel. The second withdrawal device can thereby be held securely in the second withdrawal port.
In a further refinement, a preferably transparent protective cap is arranged on the first withdrawal port. The protective cap preferably has an inner thread and is fastened onto the outer thread of the first withdrawal port in a releasable manner, in particular is screwed on or can be screwed on in the pristine state. As a result, the break-off cap is effectively protected against unintentional breaking off, dust and, and contamination. If the protective cap is formed transparently, the pristine state of said port can be checked visually through the protective cap.
In order in particular to simplify the opening of the connector system, the break-off caps of the first and/or of the second withdrawal port are each designed as flat grips, in one variant. Said caps can also merely include the flat grips. In an embodiment, the break-off caps are fitted in this manner without touching the piercing points. The break-off caps of the first and second withdrawal port preferably each have an arrow, said arrows identifying the first and second withdrawal port as withdrawal port for withdrawing a liquid.
In a refinement, the break-off cap of the first withdrawal port is higher than the break-off cap of the second withdrawal port, and/or the break-off cap of the second withdrawal port is broader than the break-off cap of the first withdrawal port. The two withdrawal ports can thereby be simply differentiated by the user. In addition, in particular the breaking off of the cap of the first withdrawal port is simplified since said cap projects upward.
The first withdrawal port and the second withdrawal port each have a membrane which is also referred to below as sealing element. The latter extends over the entire cross section of the respective channel in order to seal off the container. In an embodiment of the connector system, the first withdrawal port and the second withdrawal port each have a lower part and an upper part sitting on the lower part, wherein the upper part and the lower part are designed as connection pieces fitted on each other with snap-fit engagement, as a result of which the assembly of the connector system can be simplified. In addition, a snap-fit connection can be reproduced. In particular, a formation of particles that possibly occurs, for example, during the ultrasonic welding method can also be avoided or at least reduced by means of the snap-fit connection.
The sealing element can be clamped between the upper part and the lower part. The sealing element is preferably elastic and reclosable. The sealing element of the first withdrawal port can preferably be manufactured from a thermoplastic elastomer. However, it can also be manufactured from polyisoprene, silicone or chlorobuthyl. The sealing element of the second withdrawal port can preferably be manufactured from polyisoprene.
In order to facilitate the insertion of the withdrawal device into the membrane, the sealing element of the first withdrawal port can comprise a preferably continuous slit valve. Alternatively or additionally, the membrane of the second withdrawal port can also comprise a preferably partially punched or continuous slit valve.
In order to avoid mutual twisting of upper part and lower part and therefore possibly damage to the elastic membrane which can be arranged between the upper part and the lower part, an area of the upper part and an area of the lower part can be provided that interact for the rotation lock of the upper part and the lower part.
The sealing element of the second withdrawal port which is configured in particular for lower flow rates can have a central reinforcement area with a material thickness greater than the material thickness of an area immediately surrounding the central reinforcement area. The second withdrawal device with the spike attachment can therefore be held stably by the sealing element itself when the spike attachment of the second withdrawal device penetrates the sealing element. The sealing element of the first withdrawal port is preferably designed, in the area lying in the channel of the first withdrawal port, as a substantially flat disk. As a result, in particular the interaction with the cylinder attachment of the second withdrawal device is made possible.
In order to ensure particularly good retention of the sealing element in the second withdrawal port, a double holding device can be provided on the upper part of the second withdrawal port. In particular, a ring and a projection concentrically surrounding the ring can be formed on the upper part, extend from the upper part in the direction of the lower part and, when the sealing element is arranged as intended, lie against the sealing element in order to avoid slipping of the sealing element in the withdrawal port.
In order to secure the withdrawal device on the first withdrawal port, the first withdrawal port can have an outer thread, for example on the upper part, via which the withdrawal device can be connected to the first withdrawal port in a releasable manner.
The material of the first withdrawal port and/or of the second withdrawal port can be or can comprise polypropylene. The protective cap of the first withdrawal port can likewise be made from polypropylene or can comprise the latter.
In general, it is also conceivable for the connector system to have more than two withdrawal ports which are each of different designs.
The invention also includes a container for a medical liquid, with a connector system according to the invention. The medical liquid is preferably a rinsing liquid. The latter can be used, for example, during diagnosis and/or during operative interventions, for example in urology, cystoscopy and/or arthroscopy. The first withdrawal port is preferably used in arthroscopy. The second withdrawal port is preferably used in urology. The container is preferably a bag which has in particular a capacity of more than 1000 ml.
Furthermore, the invention also includes a system comprising an embodiment of the connector system according to the invention, in particular comprising a bag with a connector system according to the invention fastened to the bag, and a first withdrawal device with a cylinder attachment and/or a second withdrawal device with a spike attachment.
The invention will be described in detail below with reference to exemplary embodiments in conjunction with the drawings.
In the drawings:
The first withdrawal port 2 comprises an upper part 8 which sits on a lower part 10. The upper part 8 has an upper portion 8a facing away from the lower part 10 and a lower portion 8b facing the lower part 10. The upper portion 8a serves for receiving a withdrawal device 60, for example a flexible tube line, with a cylinder attachment 61. The lower part 10 has an upper portion 10a facing the upper part 8 and a lower portion 10b facing away from the upper part 8. The lower portion 8b of the upper part 8 and the upper portion 10a of the lower part 10 are designed here as connection pieces fitted on each other with snap-fit engagement and connecting the upper part 8 and the lower part 10 to each other when arranged as intended. The lower portion 10b of the lower part 10 bears the small ship 6 via which the first withdrawal port 2 can be connected to the container.
In order to form a snap-fit connection between the upper part 8 and the lower part 10, the lower part 10 has a projection 12 which extends in a plane transversely with respect to the flow direction S and encircles the lower part 10 in the circumferential direction on the outer side of the lower part 10, and the upper part 8 has a corresponding groove 14, which is provided on the inner side of the upper part 8, for receiving the projection 12. Alternatively, the projection 12 can be formed on the inner side of the upper part 8 and the groove 14 can be formed on the outer side of the lower part 10. In both cases, the upper part 8 engages in part around the lower part 10, and therefore the upper part 8 forms a female connector element and the lower part 10 forms a male connector element. Alternatively, the connection pieces can be designed in such a manner that the lower part 10 engages in part around the upper part 8 (the upper part 8 is therefore a male connector element and the lower part 10 is a female connector element). In this case, a projection or a groove is formed on the outer side of the upper part 8 and a groove or a projection is formed in a complementary manner on the inner side of the lower part 10. Another embodiment would be a connection by means of welding.
In order to avoid the groove 14 moving beyond the projection 12 in the event of a very high application of force during the connection of the upper part 8 to the lower part 10, the lower part 10 has a stop 16 which blocks the movement of the upper part 8 as soon as that end of the upper part 8 which faces the lower part 10 lies against the stop 16 when arranged as intended. This also has the advantage that a sealing element 20 which is described further below and is arranged as intended between the upper part 8 and the lower part 10 cannot be damaged during the assembly of the upper part 8 and the lower part 10.
The upper part 8 and the lower part 10 are each designed as a hollow body with a channel 18a, 18b. In the connected state, that is to say when the upper part 8 and the lower part 10 are connected to each other, the channel 18a of the upper part 8 and the channel 18b of the lower part 10 form a channel 18 which extends along the flow direction S.
A sealing element 20 is arranged on the upper portion 10a of the lower part 10, which sealing element can be opened, for example can be penetrated, by the cylinder attachment 61 of the second withdrawal device 60 in order to produce a fluid connection between a container, to which the first withdrawal port 2 can be fastened, and. In particular, the sealing element 20 rests on that end of the lower part 10 which faces the upper part 8. The sealing element 20 is designed as an elastic reclosable membrane 20. For example, the membrane 20 is manufactured from a thermoplastic elastomer. However, it can also be manufactured from polyisoprene, silicone or chlorobuthyl. The membrane 20 extends over the entire cross section of the lower part 10, at the end thereof facing the upper part, in order to seal off the first withdrawal port 2 and therefore the container. The membrane 20 comprises a preferably continuous slit valve 22 in order to permit or at least to facilitate the insertion of the cylinder attachment 61 of the withdrawal device 60 and the production of a fluid connection. The membrane 20 is suitable in particular for the use of withdrawal devices of the care-lock type.
In order to permit precise positioning of the membrane 20 on the lower part 10 and therefore to achieve the desired sealing effect of the membrane 20, the membrane has, along its circumferential edge on its side facing the lower part 10, a collar 24b projecting counter to the flow direction S. To place said collar 24b on the lower part 10, the lower part 10 has a corresponding receiving region 26b for the collar 24b. The receiving region 26b is specifically formed by a reduction in part of the external diameter of the lower part 10, at the end thereof facing the upper part 8.
In addition, the membrane 20 has, along its circumferential edge on its side facing the upper part 8, a collar 24a projecting along the flow direction S.
In order to avoid the membrane 20 being displaced axially along the flow direction S in the connected state, the upper part 8 has a receiving region 26a for the membrane 20. Above the receiving region 26a, i.e. adjacent that end of the receiving region 26a which faces away from the lower part 10, the internal diameter of the upper part 8 is smaller than the internal diameter of the receiving region 26a of the upper part 8, as a result of which a stop 28 is formed at that end of the receiving region 26a which faces away from the lower part 10 and against which the collar 24a of the membrane 20 lies when arranged as intended.
For the radial stabilization of the membrane 20, an annular projection 30 projects axially from the stop 28 in the direction of the lower part 10 into the receiving region 26a, wherein the projection 30 is arranged at a distance from the circumferential wall of the upper part 8, said circumferential wall bounding the receiving region 26a. When connected as intended, the collar 24a is arranged radially between the projection 30 and the circumferential wall. The annular projection 30 and the collar 24a are dimensioned here in such a manner that the collar 24a lies against the projection 30 and against the circumferential wall of the upper part 8, said circumferential wall bounding the receiving region 26a.
In the connected state, the membrane 20 is held radially by being placed in the receiving regions 26a, 26b, and therefore, for example when a cylinder attachment is inserted into or against the membrane 20, slipping of the membrane is avoided.
The upper part 8 is closed at its end facing away from the lower part 10 with a break-off cap 32 in order to protect the membrane 20. Furthermore, the break-off cap serves as a tamper-evident closure. In order to facilitate the breaking off of the cap 32, an encircling predetermined breaking point 34 is formed between the cap 32 and that end of the upper part 8 which faces away from the lower part 10. Furthermore, a grip 36 is provided on the cap 32 in order to be able to grip the cap 32 to break the latter off.
In order to prevent the break-off cap 32 from breaking off accidentally, for example during transport of the first withdrawal port 2, the break-off cap 32 is surrounded by a protective cap 38 which is fastened to the upper portion 8a of the upper part 8 via a screw connection. In order to produce the screw connection, a thread 40a is provided on the outer side of the upper portion 8a of the upper part 8 and a thread 40b is provided on the inner side of the protective cap 38. The thread 40a of the upper part 8 furthermore serves to additionally fasten a withdrawal device 60, which comprises a union nut with an internal thread 61-3, to the upper part 8 in order to prevent inadvertent slipping of the withdrawal device 60 out of the membrane 20 (see
In order to prevent the upper part 8 from rotating with respect to the lower part 10, for example during breaking off or twisting off of the tamper-evident cap 32 or when unscrewing the protective cap 38 or when the withdrawal device 60 is connected, a rotation lock is provided. The rotation lock is formed by elements which are different from the elements for producing the snap-fit connection between the upper part 8 and the lower part 10. For the rotation lock, a tooth profile 42a is formed along the circumferential direction on the inner side of the upper part 8 and a tooth profile 42b is formed on the outer side of the lower part 10, wherein the teeth of the tooth profiles 42a, 42b extend axially along the flow direction S. In the exemplary embodiment illustrated in
Alternatively, other means are conceivable for the rotation lock, such as, for example, a pin and a corresponding receptacle or an axial web or a plurality of axial webs on the lower part 10 and accordingly a groove or a plurality of grooves in the upper part 8, said means extending along the flow direction S.
The channel 18 has a length l of 5 to 8 cm, preferably of 6 to 7 cm, in particular preferably of 6.5 cm. The stated length l corresponds to the length after removal of the break-off cap 32. The portion of the upper part 8 that lies between that end of the upper part 8 which faces away from the lower part 10 (after removal of the break-off cap 32) and the receiving region 26a has a length l1 of 0.8 to 1.6 cm, preferably of 1.0 to 1.4 cm, particularly preferably of 1.2 cm. Said portion substantially corresponds to the upper portion 8a of the upper part 8, which serves for receiving a withdrawal device.
The channel 18b of the lower part 10 is of slightly conical design, and therefore the internal diameter of the channel 18b of the lower part 10 varies over the length of the channel 18b. Thus, the internal diameter of the channel 18b at its end facing the upper part 8 is 5 to 8 mm, preferably 6 to 7 mm, in particular preferably 6.5 mm. The internal diameter of the channel 18b at its end facing away from the upper part 8 is 2 to 6 mm, preferably 3 to 5 mm, in particular preferably 4 mm. Furthermore, the internal diameter of the channel 18a of the upper part 8 at its end facing away from the lower part 10 is 4 to 8 mm, preferably 5 to 7 mm, in particular preferably 6 mm.
The second withdrawal port 4 (
The second withdrawal port 4 differs from the first withdrawal port 2 by the fact that a second withdrawal device 70 with a spike attachment 71 can be attached.
It therefore differs in particular also in terms of its dimensions. The channel 18 of the second withdrawal port 4 has a length 3 of 3.5 to 6.5 cm, preferably of 4.5 to 5.5 cm, in particular preferably of 5 cm. The stated length l corresponds to the length after removal of the break-off cap 33. The break-off cap 33 of the second withdrawal port 4 has a greater breadth and a smaller height here than the break-off cap 32 of the first withdrawal port 2. The break-off cap 33 here comprises a flat grip 37. The portion of the upper part 8 which lies between that end of the upper part 8 which faces away from the lower part 10 (after removal of the break-off cap 33) and the receiving region 26a has a length l1 of 2 to 5 mm, preferably of 3 to 4 mm. This portion substantially corresponds to the upper portion 8a of the upper part 8, which serves for receiving a withdrawal device.
The channel 18b of the lower part 10 is of slightly conical design, and therefore the internal diameter of the channel 18b varies over the length of the lower part 10. Thus, the internal diameter of the channel 18b at the end 5 facing the upper part 8 is 5 to 9 mm, preferably 6 to 8 mm, in particular preferably 7 mm. The internal diameter of the channel 18b at the end facing away from the upper part 8 is 2 to 6 mm, preferably 3 to 5 mm, in particular preferably 4 mm. Furthermore, the internal diameter of the channel 18a of the upper part 8 at the end facing away from the lower part 10 is 4 to 8 mm, preferably 5 to 7 mm, in particular preferably 6 mm.
In contrast to the first withdrawal port 2, the membrane 21 of the second withdrawal port 4 is manufactured from polyisoprene. A slit valve is preferably not formed in the membrane 21 of the second withdrawal port 4. Said membrane 21 can be pierced by the pointed spike attachment and therefore opened. However, in order to simplify the opening, a preferably continuous or partially punched slit valve can also be formed here.
In addition to the collar 24a facing the upper part 8 and the collar 24b facing the lower part 10, the membrane 21 of the second withdrawal port 4 has a central reinforcement area 44 which, when arranged as intended, is provided on that side of the membrane 21 which faces the upper part 8. The central reinforcement area 44 is located in an area bounded by the collar 24a, wherein the collar 24a is spaced apart from the central reinforcement area 44 by an annular gap 46. The central reinforcement area 44 has a height (material thickness along the flow direction S starting from that side of the membrane 21 which faces the upper part 8) which substantially corresponds to the height of the collar 24a. Since the portion of the upper part 8 which lies between that end of the upper part 8 which faces away from the lower part 10 (after removal of the break-off cap 33) and the receiving region 26a is relatively short, the membrane 21 which is reinforced by the central reinforcement area 44 can assist the retention of the spike attachment 71, which is also referred to as an insert spike, which sticks into the membrane 21. By means of this configuration, reclosing of the membrane 21 after removal of the spike attachment 71 can also be assisted.
In order to retain the membrane 21, a receiving region 26a is provided in the upper part 8 and a receiving region 26b is provided in the lower part 10, as in the first withdrawal port 2. However, in the case of the second withdrawal port 4, in addition to the projection 30, a ring 48 extending concentrically with respect to the projection 30 projects into the receiving region 26a. The ring 48 extends from that end of the upper part 8 which faces away from the lower part 10 within an area bounded by the projection 30 and ends substantially at the same height as that end of the projection 30 which faces the lower part 10. The ring 48 is secured at an axial end at that end of the upper part 8 which faces away from the lower part 10 and is therefore designed to be resilient in the radial direction. Both the projection 30 and the ring 48 lie in the annular gap 46 of the membrane 20 on that side of the membrane 20 which faces the upper part 8 when the membrane 21 is arranged as intended. Furthermore, the second withdrawal port 4 does not have an additional protective cap to protect the break-off cap 33.
In addition, at the second withdrawal port 4, the upper part 8 is not yet fitted on the lower part 10. The arrows 55, 56 on or in the break-off caps 32 and 33, which arrows identify the two withdrawal ports 2 and 4 as withdrawal ports, can clearly be seen. The two arrows are introduced here by way of example as openings in the two caps 32 and 33.
The spike attachment 71 of the second withdrawal device 70 can also be referred to as insert spike or spike. Said spike attachment is inserted into the second withdrawal port 4, uses its point to pierce the membrane 21 and thereby produces a fluid connection. In the inserted state, the spike attachment 71 is held in its position in particular by means of clamping by the membrane 21 and/or the channel 18 and/or by the channel portion above the membrane. The channel 18 of the second withdrawal port 4 is of such a length here that the insert spike 71, in the fully inserted state, extends at least half way along the channel 18. The second withdrawal device 4 can thereby be held securely in the second withdrawal port 4.
The cylinder attachment 61 comprises the inner, substantially cylindrical tubular portion 61-1 which can be inserted into the first withdrawal port 2. The tubular portion 61-1 opens the membrane 20 at the latest in the fully inserted state. The end surfaces of the tubular portion 61-1, which end surfaces press against the membrane 20, are arranged here substantially perpendicularly to the longitudinal axis of the cylinder attachment 61. As illustrated here, the end surfaces or the front portion of the tubular portion 61-1 can have a cut and/or a cone in order to assist the opening of the membrane 20. The cylinder attachment 61 is preferably an attachment of the care-lock type. The cylinder attachment 61 is formed in particular by two concentric tubular portions 61-1 and 61-2 of different length. In this configuration, the outer tubular portion 61-2 has a larger diameter and extends beyond the inner tubular portion 61-1. The two tubular portions 61-1 and 61-2 are of substantially cylindrical design. On the inner side of the outer tubular portion 61-2, a thread 61-3 is arranged in the lower area which lies in the direction of the drip chamber. The cylinder attachment 61 is connected to the withdrawal port 2 by screwing. During the screwing-in operation, the inner shorter tube 61-1 is moved in the direction of the membrane 20 which initially closes the port 2 in a liquid-tight manner. The cylinder attachment 61, here the inner tube 61-1, opens the membrane 20 at the latest in the fully screwed-on state and produces a fluid connection. At least the front area of the inner tubular portion 61-1 penetrates the membrane 20.
It is apparent to a person skilled in the art that the described embodiments should be understood as being by way of example. The invention is not restricted to them, but rather can be varied in diverse ways without departing from the essence of the invention. Features of individual embodiments and the features mentioned in the general part of the description can each be combined among one another or with one another.
Number | Date | Country | Kind |
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14199473.1 | Dec 2014 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2015/080601 | 12/18/2015 | WO | 00 |