HK1179194B - Connector for containers containing medical agents - Google Patents

Description

Technical field

The invention relates to a connector for containers containing a medicinal product which allows the transfer of medicinal product from one container to another.

State of the art

EP 2 095 805 A2 reveals a connector for a container containing a medicinal product which comprises a first connecting section for the connection of a glass bottle, a second connecting section for the connection of a flexible bag and an axially movable through-hole formed in the form of a double-sided sharpened needle. The through-hole is axially displaced in a first housing section of a connector housing. The first housing section is telescopically displaced on a second housing section. In the initial position of the connector the first housing section and the second housing section are displaced from each other. The glass housing section is displaced in the first glass housing section and the second housing section is displaced in the opposite direction.A membrane placed in the neck of the glass bottle, which closes the glass bottle, hits one end of the puncture element. The puncture element is carried along while pushing the glass bottle until it hits a membrane closing the flexible bag with its other end. Further pushing the glass bottle pushes both the membrane on the side of the flexible bag and the membrane of the glass bottle through the puncture element. A puncture for the movement of the puncture element limits the movement of the puncture element and ensures that not only the pocket-like membrane but also the membrane of the glass bottle is opened.

The disadvantage of this connector is that it contains moving parts with the two housing sections which must be sealed against each other. Furthermore, the connector contains a large number of elements which make the connector complex and expensive to manufacture. A self-sealing Male-Luer connector which also has a large number of seals is described in WO 2006/062912 A1.

A brief description of the invention

The connector of the invention for containers containing medicinal products shall consist of a first connecting section for the connection of a first container, a conductor, a puncture element and a separation wall, the conductor having a channel designed for the transfer of a medicinal product, the puncture element being located at least intersectively in the channel and being axially moved within the channel by the conductor, and by connecting a container the puncture element from an outlet where the puncture element does not open the separation wall to an end position where the puncture element is movable to open the separation channel for the transfer of a medicinal product.

The conductive element can perform a dual function by forming both the channel through which an active substance can be transferred and a bearing in which the puncture element can be moved axially, thereby reducing the number of connector elements and making the connector cost-effective, thus reducing the number of interfaces and improving the handling of the connector. The connector according to the invention allows in particular the transfer of the medical active substance without risk of contamination.

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The partition can be a flexible partition, for example made of an elastic material, especially in the form of a membrane, but also, preferably, a rigid partition that is broken or pierced by the puncture element.

In a preferred embodiment, the puncture element and the guide element are designed to allow a free space for the transfer of a medicinal product between an outer surface of the puncture element and an inner surface of the guide element forming the channel. In an alternative embodiment, the puncture element and the guide element are designed to allow the transfer of the medicinal product to be carried out in addition to or exclusively by the puncture element. The puncture element may be designed for the respective purpose or as a solid body. A combination of solid body and solid body is also basically possible. The profile of the puncture element changes exponentially, with the result that the average of its torque is reduced to eight times the torque of the puncture body, or the average of its torque is reduced to one-half of the total torque of the puncture body.and the end section facing the container to be connected is formed in such a way that pressure is exerted on the end section by means of the container to push the piercing against the partition wall. For this purpose, the end section facing the partition wall may be formed, for example, by a linear or cross-shaped profile running vertically, or the other end section by a surface forming, for example, by a cross-shaped or rounded profile. In the case of the average end section forming a hollow body, the end section facing the partition wall may be formed by a facet grinding hammer or a pointed tip,

In a preferred embodiment, the guide element and the partition are unidirectional, in a particularly preferred embodiment, they are individually formed.

The connector of the invention comprises a housing forming the first connection area. Preferably, the housing, the guide element and the partition are unidirectional, preferably in single-piece form. The single-piece and, where appropriate, single-piece forming of several functional elements reduces the number of parts of the connector and reduces the manufacturing costs.

In another preferred embodiment, the punch, guide, partition and/or housing is made of a plastic material, preferably polypropylene (PP) or a blend of polypropylene and styrene/ethylene butylene/styrene (SEBS). In particular, the punch, guide, partition and/or housing may be injection-molded parts. The punch may alternatively be made of, for example, polycarbonate (PC) or polystyrene (PS).

According to the invention, the guide element comprises a terminal section designed to penetrate a membrane of a container that can be connected to the first connection area, for example, to penetrate a rubber stopper of a glass bottle.

In another preferred embodiment, the first connecting section is formed as a Luer connection of a Luer lock, in particular as a male part. The guide element is in this case partially or completely formed by the central cone of the Luer connection. By connecting the female part, the connecting element is preferably pushed from its outlet into the end position where the partition is open when screwing the connection. The connecting part of the counterpart of the Luer connection is thus connected with an opening of the partition, which can eliminate an additional movement layer.

Other advantageous embodiments of the invention are the subject of the dependent claims.

The invention is explained in more detail below by means of examples of execution illustrated by several figures.

A brief description of the figures

It shows: Fig. 1 a longitudinal section through a first embodiment of a connector of the invention,Fig. 2 a section through the connector shown in Fig. 1 along the line C-C.Fig. 3 a first perspective view of the connector shown in Fig. 1,Fig. 4 a second perspective view of the connector shown in Fig. 1,Fig. 5 a section of the cross-section of the connector shown in Fig. 1,Fig. 6 a perspective view of the connector shown in Fig. 1 cut along the longitudinal axis in an output tube,Fig. 7 a perspective view of the cross-section of the connector shown in Fig. 1 on the front of a glass pane,Fig. 8 a perspective view of the cross-section of the glass pane,Fig. 8 a perspective view of the cross-section of the glass pane,Fig. 8 a perspective view of the cross-section of the glass pane,Fig. 8a perspective view of the connector with the glass bottle in the connected end position shown in Fig. 1, a perspective view of the first connection area of the connector shown in Fig. 1, a side view of a second embodiment of a connector of the invention with a Luer-female part connected to the connector, a perspective view of the connector with the glass bottle in the connected end position shown in Fig. 11, a perspective view of the connector with the Luer-female part shown in Fig. 11, a perspective view of the Luig-Female part shown in Fig. 13, a perspective view of the Luig-Female part shown in Fig. 11, a perspective view of the Luig-Female part shown in Fig. 14, a view of the Luig-Female part shown in Fig. 15.14 pointed out in Fig. 16 a perspective view of the connector cut along the longitudinal axis, shown in Fig. 11, before the connection of the Luer-female part,Fig. 17 a perspective view of the connector cut along the longitudinal axis, shown in Fig. 11, with the Luer-female part connected,Fig. 18 a perspective view of the puncture element of the connector shown in Fig. 11.

Description of the embodiments

Figures 1 to 10 show, from various points of view, an initial embodiment of a connector 1 of the invention for containers containing medicinal products.

Connector 1 comprises a first connector 3 for connecting a first container, a guide element 4, a puncture element 5, a partition 6 and a second connector for connecting a second container. The first connector 3 is trained here for connecting a medical glass bottle. The second connector 12 is trained here for connecting a flexible bag. Alternatively, the first connector 3 and/or the second connector 12 can of course also be trained for other containers, for example plastic bottles or transfer systems.

Connector 1 consists of a housing 9 with a hollow cylindrical housing section 10 forming the first connecting section 3 and a housing base 11.The conductor 4 is formed as a tube-like hollow body with a channel 7 for the transfer of a medicinal product and is connected to the housing base 11 at the centre of the housing base 11.One end of the conductor ends at the housing base 11, the other end protrudes into the connecting section 3 and thus into the inner area of the housing base 3.The end sections 8 of the conductor 4 connected to the connecting channel 14 or connected to a common conductor base 14 are arranged in a common axis and are connected to a membrane of 3 to 15 conductors.

Furthermore, connector 1 comprises a connector 13 forming the second connector area 12; connector 13 is tubular, arranged along the symmetry axis 15 and connected by an end at the rear of the body floor 11 opposite to the connector area 3; at the other end, connector 13 comprises two mirror-symmetrically formed welding flasks 16 for connecting connector 13 to a flexible plastic bag not shown in detail; and connector 13 comprises two lateral reinforcement steps 17 running along the symmetry axis 15 which run mirror-symmetrically from the ground 11 to the welds 16 and are intended to strengthen the connector.

In particular, partition 6 is located at the end of the guide element 4 facing the first access area 3 and closes in a closed position with the rear of the housing floor 11. Instead of partition 6 being located at one end of channel 7, an alternative arrangement of partition 6 is also located within channel 7 of the guide element 4. Furthermore, partition 6 may be arranged in such a way that it separates from the tread floor 11, for example by a clear opening of the tread on the ground. In this case, partition 6 may be arranged on at least one channel 6 and, if possible, on at least one channel 6 of the tread.

The partition 6 is formed as a wall with a wall thickness of sufficient thickness to be pierced and/or broken by the piercing element 5. In this embodiment, the partition is formed in such a way that it remains open after piercing/breaking when the piercing element 5 is pulled out, which is preferable.

In this example, housing 9, conductor 4, partition 6 and connector 12 are made of plastic, in this case PP or a blend of PP and SEBS, as an injection moulding component, which makes the connector particularly cost-effective to manufacture.

The piercing element 5 is shaped as a massive rod in this embodiment. The piercing element is arranged in channel 7 and is axially moved within channel 7 by the guide element 4. Between the inner surface of channel 7 and the outer surface of the piercing element 5 there is an axially running free space with a sufficient cross-section to allow medicinal active substance to pass through sufficiently quickly between the first connection part 3 and the second connection part 12. The piercing element 5 here also has a cross-shaped profile that alternately passes through the outer dimensions of the roughly square or quadratic guide element 4 so that the conductor element 5 does not interfere with the inner surface. For example, the piercing element 5 can be used in the form of a complete or partial piercing, or it can also be used in the form of a complete or partial piercing, or it can be used in the form of a complete or partial piercing, such as a piercing through a carrier or through another profile.

Furthermore, the piercing element 5 is soluble pre-fixed in an initial position in which the piercing element 5 does not open the partition 6. For this purpose, the piercing element 5 comprises two opposite protrusions 18 which intervene in the initial position in two corresponding notches 19 in the guide element 4 soluble. By applying sufficient pressure on the piercing element 5, as may be exercised, for example, when connecting a glass bottle in the first connection area 3, the piercing element 4 can be dissolved from the initial position and transferred to an alternate position. When the piercing element 4 of the initial position is transferred to the final position, the piercing element 4 opens the separator element 6 in the initial position and they can also pass through Fig. 6 to 9.

To facilitate the break-up or puncture of the partition, the puncture element 5 is sharpened or sharpened at its end facing the partition 6. At its other end, the opposite end of the partition 6, the puncture element 5 forms a support surface to absorb the pressure of a container to be connected as widely as possible and to prevent the puncture element 5 from entering the container unwanted, for example, by punching a rubber stopper of the container.

In this embodiment, the punch element 5 is made of a single piece of plastic, preferably PP, PC or PS, as an injection moulding component, or alternatively, the punch element 5 may be multi-part and/or composed of other materials, such as metal and/or multiple materials.

The connector also incorporates a soluble cover film 21 which closes the first connection area 3 and protects against contamination, such as contamination by accidental contact.

Figures 6 to 9 show the connection of a glass vial 2 to connector 1.

Fig. 6 shows the connector 1 in its original state. To connect a glass bottle 2, the cover sheet 21 is first manually removed. The glass bottle is then inserted with its neck into the first connection area 3, see Fig. 7. When inserting the glass bottle 2, the glass bottle 2 applies a 5 axial pressure on the piercing element 5 extending beyond the guide element 4 facing the glass bottle 2 to the end of the piercing element 5 which pushes the piercing element 5 against the piercing wall with its end facing the partition 6 until the piercing element 5 has passed through the partition 6 through the pressure. By extending the piercing element 2 the piercing element 5 is moved axially,In the case of the glass bottle, the position of the glass bottle is not the same as that of the bottle, but the position of the bottle is the same as that of the bottle. In the case of the bottle, the position of the bottle is the same as that of the bottle.

When the container 2 is pushed further into the connecting area 3, the membrane 14 is pushed through the cannula-like end section 8 of the guide element 4, see Figure 9. An active substance, such as a liquid or powder, contained in container 2 can now be transferred through connector 1 and diluted and/or dissolved, for example, in a flexible bag connected to the connecting agent 13, or vice versa. When the container 2 is pushed further, the container 2 reaches an end position in which one or more protrusions 23 on the inside of the container connecting section 10, for example, prevent them from reaching the container 2 behind the first container connecting section 10, for example, Figure 8.

In the connection area 3 a further rear section may be provided, for example by additional protrusions, which fix the container 2 already in the docking position by forming a form lock.

The pre-mounted container 2, the connector 1 and a container connected to the connector 1, in particular a bag, can be included in a bag as a set, allowing safe mixing of the components outside the laminar flow area without the risk of contamination.

Figures 11 to 18 show a second embodiment of a connector 1 of the invention for containers containing a medicinal product in different views. Elements or components corresponding to those of the first embodiment were marked with the same reference marks used to mark the components of the first embodiment.

The connector 1 according to the second embodiment comprises a first connecting section 3', a guide element 4', a passing section 5', a partition 6', and a second connecting section 12. The second connecting section 12 is formed by a connecting device 13 corresponding to the first embodiment. The first connecting section 3', by way of derogation from the first embodiment, is formed as a Luer connection of a Luer lock (ISO 594/1) here as a Luer male part. Connecting section 3', guide element 4', passing element 5' and connecting devices 13 are arranged along the common symmetry axis 15.

The connector 1 comprises a 9' housing with a 10' essentially cylindrical housing section with an inner windscreen and a 11' housing base forming the 3' connecting area. The 4' conductor is formed as a hollow outer cone and protrudes into the 3' connecting area. Through the formation as a hollow body, the 4' conductor comprises an inner channel 7 intended for the transfer of a medicinal product. The 4' conductor is connected to the 11' housing base in the centre of the 11' housing base.

The partition 6 shall be located and formed in the same way as partition 6 in the first design at the level of the 11' housing floor; in the closed state, partition 6 shall prevent the transport of a medicinal product between the first 3' and the second 12' housing.

The 5' through-hole is made in the form of a hollow tube. The 5' through-hole is arranged in sections in channel 7 and is moved axially within channel 7 by the 4' guide element. The outer diameter of the 5' through-hole is adjusted in the guided section to the inner diameter of the 4' guide element for the best possible free storage. At its first 3' side-facing end the 5' through-hole has a collar 24, attached to Fig. 5, at its first 3' side-facing end the 5' through-hole is often tightened or tightened to facilitate the separation of the 6' through-hole.see Fig. 16, the collar 24 is spaced from the 4' guide element, in an end position where the 5' puncture element opens the 6 partition to transfer a medicinal product, the 24 collar is on the upper 25 edge of the 4' guide element, see Fig. 15 and 17, blocking further insertion of the 5' puncture element into the 4' guide element. Alternatively, the 5' puncture element may also be formed as a massive body, e.g. with a cross-shaped, star-shaped, spire-shaped or similar profile. In this case, a body between the inner surface of the 4' guide element and the outer airflow of the 5' puncture element is useful for the transport of the medicinal product.

Housing 9', guide element 4', partition 6 and connector 6 are manufactured in this embodiment as a single-piece and single-unit injection moulding part of a plastic, preferably PP or a PP-SEBS blend. In principle, a multi-piece moulding and the use of other and/or different materials would also be possible. The 5' through-hole element is also a single-piece and single-unit injection moulding part of plastic, preferably PP. PC or PS. Here, too, a multi-piece moulding and the use of other and/or different materials as an alternative would be in principle possible.

The figures shown show a container element next to the connector 1 and a Luer female part 2' connected to the connector 1 and the Luer female part 2' may be part of a syringe or a transfer system.

16 shows the condition after the insertion of the luer female part 2' and before the insertion of the luer female part 2' with the luer male part of the connector 1'. In this position the guide element 4' with the protruding piercing element 5' is already partially inserted into the inner cone of the luer female part 2'. The outer diameter of the bracket 24 of the piercing element 5' is adjusted to the diameter of the inner cone of the luer female part 2', so that the collar 24 is not completely permeable to the inner cone but is penetrated through the outer edge of the rejuvenating inner cone, near the end of the conical end of the luer female part.The femoral cutting element 5' attached to the collar 24 is accompanied by the femoral cutting element 2' in this movement and the divider 6 is broken or pushed open by the sharpened or pointed end of the femoral cutting element 5', see Figure 17. The connection between the first cutting area 3' and the second cutting area 12 is now open, allowing the transport of a medicinal product between a flexible container or bag connected to the femoral cutting area 12 by the connector 1 and another container connected by the femoral cutting area 2.

The connecting section 3' of connector 1 with 5' threaded element may be covered by a manually removable cap (not shown) to protect against contamination and/or to protect against unwanted opening of the partition 6 by moving the 5' threaded element. Furthermore, the 5' threaded element is preferably pre-fixed in its extended output, for example by means of a spring-nut connection similar to that of the first embodiment. A fixing of the 5' threaded element is also in the final position, for example to prevent a possible fall of the 5' threaded element when loosening the 2' threaded part.

The advantage of the 1, 1 connectors of the invention is that they are inexpensive to manufacture, and that a sterile connection between two containers can be made easily, safely and quickly by hand, and that the conductive element 4, 4' and the puncture element 5, 5' can be formed with suitable profiles to rapidly transfer a medicinal product.

Claims (13)

1. Connector (1, 1') for containers containing medicinal active ingredient, comprising a first connection region (3, 3') for the connection of a first container (2, 2'), a guide element (4, 4'), a piercing element (5, 5') and a partition wall (6), wherein the guide element (4, 4') has a duct (7) designed for transferring a medicinal active ingredient, the piercing element (5, 5') is arranged, at least in certain sections, in the duct (7) and is axially movably guided within the duct (7) by the guide element (4, 4'), and, by connecting a container (2, 2') in the first connection region (3, 3'), the piercing element (5, 5') can be moved from a starting position, in which the piercing element (5, 5') does not open the partition wall (6), into an end position, in which the piercing element (5, 5') opens the partition wall (6) in order to transfer a medicinal active ingredient, characterized in that the guide element (4, 4') has an end section (8) which is designed to pierce and/or break open a membrane (14) of a container (2, 2') which can be connected into the first connection region (3, 3'), and/or, in that the connector (1, 1') comprises a housing (9, 9') with a housing section (10, 10'), forming the first connection region (3, 3'), and a housing base (11, 11'), wherein the guide element (4, 4') is connected to the housing (9, 9') at the housing base (11, 11').
2. Connector (1, 1') according to Claim 1, wherein the piercing element (5, 5') projects by its end facing the first connection region (3, 3') beyond the guide element (4, 4').
3. Connector (1, 1') according to one of the preceding claims, wherein the piercing element (5, 5') and the guide element (4, 4') are designed in such a way that a clearance for transferring a medicinal active ingredient remains between an outer face of the piercing element (5, 5') and an inner face, forming the duct (7), of the guide element (4, 4').
4. Connector (1, 1') according to one of the preceding claims, wherein the piercing element (5, 5') is designed as a solid body and/or as a hollow body.
5. Connector (1, 1') according to one of the preceding claims, wherein the piercing element (5, 5') consists at least partially, preferably completely, of a plastic, preferably of polypropylene, polycarbonate or polystyrene.
6. Connector (1, 1') according to one of the preceding claims, wherein the partition wall (6) is arranged within the duct (7) or at an end of the duct (7).
7. Connector (1, 1') according to one of the preceding claims, wherein the partition wall (6) is arranged at the end of the piercing element (5, 5') facing away from the first connection region (3, 3').
8. Connector (1, 1') according to one of the preceding claims, wherein the piercing element (5, 5') is releasably prefixed in the starting position.
9. Connector (1, 1') according to Claim 1, wherein the connector (1, 1') is designed such that, when connecting to the first connection region (3, 3') and transferring the container (2, 2') into an upstream container docking position, at first the partition wall (6) is opened by the piercing element (5, 5'), and, when transferring the container (2, 2') into a container end position, the membrane (14) of the container (2, 2') is opened by the guide element (4, 4').
10. Connector (1, 1') according to one of the preceding claims, additionally comprising a second connection region (12) for the connection of a second container, wherein the partition wall (6) is arranged such that in the closed state it prevents the transport of a medicinal active ingredient between the first connection region (3, 3') and the second connection region (12).
11. Connector (1, 1') according to Claim 10 in conjunction with Claim 9, wherein the second connection region (3, 3') is formed by a connecting means (13) connected to the housing base (11, 11').
12. Connector (1, 1') according to Claim 11, wherein the housing (9, 9') and the connecting means (13) are one-part, preferably integral.
13. Connector (1, 1') according to one of the preceding claims, wherein the first connection region (3, 3') is designed for the connection of a glass bottle or as a Luer connection.