Connection assembly for guiding a medical liquid

Abstract

The invention relates to a connection assembly for conducting a medical fluid, comprising a connection piece (11) through which a medical fluid can be conveyed, an attachment part (2) which can be attached to the connection piece (11), which can be connected to a conveying device (5) for conveying a medical fluid through the connection piece and has an opening (210) into which the connection piece (11) engages when the attachment part (2) is attached to the connection piece (11), and a sealing element (4) for sealing a transition between the connection piece (11, 12) and the attachment part (2), wherein the sealing element (4) can be inserted in an insertion direction (E) into the opening (210) of the attachment part (2) such that when the attachment part (2) is attached to the connection piece (11), the sealing element (4) is held between the attachment part (2) and the connection piece (11). The sealing element (4) has a sealing head (40),which, when the attachment part (2) is attached to the connecting piece (11), closes the opening (210) of the attachment part (2) against the passage of fluid, and a body (42) adjoining the sealing head (40) which can be arranged in the opening (210) at a radial distance from the attachment part (2). An interior of the sealing element (4) is free of a body with a tip which is intended to assist the opening of the sealing head (40). It is provided that the sealing element (4) has, at the transition between the sealing head (40) and the body (42), a shoulder (410) projecting radially over the sealing head (40) in relation to the insertion direction (E), which shoulder can be brought into contact with an associated contact surface (212) within the opening (210) of the attachment part (2) along the insertion direction (E), and a flange (420) spaced apart from the shoulder (410) along the insertion direction (E) and projecting radially outwards relative to the body (42) of the sealing element (4),which, when the attachment part (2) is attached to the connecting piece (11), is held between the attachment part (2) and the connecting piece (11) in such a way that the flange (420) rests with its underside (422) on a support surface (114) of the connecting piece (11) and its upper side (421) is at least partially exposed, and has a foot section (43) which, when the attachment part (2) is attached to the connecting piece (11), engages in an associated recess (113) in the connecting piece (11). In this way, a connection assembly for conducting a medical fluid can be provided, which enables a reliable hold of the sealing element between the connecting piece and the attachment part.

Description

[0001] The invention relates to a connection assembly for conducting a medical fluid according to the preamble of claim 1.

[0002] Such a connection assembly can be used, for example, on a container for medical fluids, such as a flexible bag, ampoule, or other bottle-shaped container, to convey a medical fluid into the container or to remove it from the container. Such a connection assembly can also be referred to as a connector for short.

[0003] In a connector for a package containing a medical fluid, known from WO 2005 / 037362 A1, a self-sealing membrane is inserted into a channel-shaped recess of a connecting part. The channel-shaped recess is closed by a breakaway piece that can be broken off from the connecting part to release the channel-shaped recess, allowing a syringe with a connecting nozzle to be attached to the connecting part. By attaching the syringe to the connecting part, the membrane can be opened, allowing a fluid to be pumped into or out of a container.

[0004] In a connector known from WO 2010 / 034470 A1, a hollow body with a tip is arranged on one side of a membrane facing away from a syringe that is attached to the membrane. The hollow body supports the opening of the membrane. When the syringe is attached to the connector, the membrane is pressed by the syringe onto the tip of the hollow body, causing the syringe to engage with the hollow body and thus enabling flow through the membrane and the hollow body.

[0005] A valve unit with a hollow body that assists in opening the membrane is also described in WO 93 / 11828 A1. The document shows a needle-free valve unit with a tubular body defining an internal cavity. The valve unit further comprises a hollow spike with a closed tip arranged within the cavity. The valve unit further comprises an elastic silicone seal that closes the valve unit and covers the tip of the spike. The seal has a sealing head, a conical sidewall, and a lower sealing lip. The lower sealing lip is clamped between an annular collar and the underside of a ring.

[0006] Such connectors are used, for example, to create so-called needle-free access to a container containing a medical fluid, such as a bag or bottle, in order to fill or remove fluid from the container via the access. Such needle-free access enables access to the container using a delivery device that does not have an injection needle. Instead, a connecting piece of a delivery device in the form of a syringe, for example, is attached to a slotted opening of a sealing element to open the slotted opening and enable flow between the delivery device and the container.

[0007] By using needle-free access, the risk of injury that would otherwise occur when using injection needles can be reduced.

[0008] Even if the sealing element is already provided sterile, legal requirements may require the sealing element to be wiped or swabbed on its exterior before connecting a conveying device to the attachment. This is intended to ensure access, for example, to a container, under sterile conditions. Such swab- or wipe-able connectors are known, for example, from EP 1 470 352 B1 and EP 1 217 284 B1.

[0009] US 2010 / 0298782 A1 describes an intravascular valve component comprising a valve housing and a flexible, pressure-actuated flow control valve. The housing includes a proximal and distal housing portions connected to each other. The valve includes a slotted central valve wall and an annular flange surrounding the valve wall. The flange has a radially extending flange wall and a projection extending axially from the flange wall. The projection engages a portion of the valve housing to limit radial movement of the valve relative to the housing.

[0010] The object of the present invention is to provide a connection assembly for conducting a medical fluid that allows for a reliable hold while also allowing a certain degree of mobility of the sealing element. In particular, the flow should not be significantly impaired. A further object is to provide a connection assembly that allows for a sealing element to be easily wiped or dabbed for disinfection purposes.

[0011] This object is achieved by an article having the features of claim 1.

[0012] It is a connection assembly for conducting a medical fluid. It comprises a connection piece through which a medical fluid can be conveyed, and an attachment part that can be attached to the connection piece and is connectable to a conveying device for conveying a medical fluid through the connection piece. The attachment piece preferably has an opening into which the connection piece engages when the attachment part is attached to the connection piece. The connection assembly also comprises a sealing element for sealing a transition between the connection piece and the attachment part. The sealing element can preferably be inserted into the opening of the attachment part in an insertion direction such that when the attachment part is attached to the connection piece, the sealing element is held between the attachment part and the connection piece. In particular, an interior of the sealing element is free of a body with a tip that is intended to assist the opening of the sealing element.

[0013] The sealing element has a sealing head which, when the attachment part is attached to the connecting piece, closes the opening of the attachment part against the passage of liquid, and a body adjoining the sealing head which can be arranged or is arranged in the opening at a radial distance from the attachment part.

[0014] The sealing element has at the transition between the sealing head and the body, a shoulder projecting radially over the sealing head in the direction of insertion, which shoulder can be brought into contact with an associated contact surface within the opening of the attachment part along the direction of insertion, and a flange spaced apart from the shoulder along the direction of insertion, projecting radially outwards relative to the body of the sealing element, which flange is held, preferably clamped, between the attachment part and the connection piece when the attachment part is attached to the connection piece, on.

[0015] When the attachment part is attached to the connecting piece, the sealing element is held between the attachment part and the connecting piece in such a way that the flange rests with its underside on a support surface of the connecting piece and its upper side is exposed at least in sections. The sealing element comprises a foot section which, viewed axially along the insertion direction (E), adjoins the body below the flange and, when the attachment part is attached to the connecting piece, engages in an associated recess in the connecting piece.

[0016] When the attachment part is attached to the connecting piece, the sealing element is held in a clamping manner between the attachment part and the connecting piece, such that a transition between the attachment part and the connecting piece is sealed in a liquid-tight manner. The sealing element has a shoulder which runs around the insertion direction, projects radially outwards beyond the sealing head and - when the attachment part is attached to the connecting piece - rests against an associated contact surface of the attachment part. The sealing element is thus supported by the shoulder, in particular axially along the insertion direction relative to the attachment part, such that the sealing element is axially fixed relative to the attachment part via the shoulder. The diameter of the sealing element in the region of the shoulder is preferably in a range from 4 mm to 10 mm, more preferably from 6 mm to 8 mm.Because the sealing element is supported with the shoulder on the one hand on the attachment part and via its flange and the foot section on the other hand on the connecting piece, a defined, secured position of the sealing element within the opening of the attachment part can be ensured.

[0017] The sealing element body, which is particularly cylindrical, adjoins the shoulder. The sealing element as a whole preferably has a rotationally symmetrical shape, whereby different sections of the sealing element can have different diameters. The body adjoining the shoulder is arranged with radial play in the opening of the attachment part, so that a space exists around the body within the opening of the attachment part, into which space the sealing element can deform when a conveying device is applied to the attachment part.Because there is space in the opening radially outward towards the wall of the attachment part, into which the sealing element can be pushed aside when a conveying device, for example a syringe, is attached to the sealing element with a connecting piece, a slotted opening on the sealing head of the sealing element can be opened in a reliable manner and, in the open state, a flow between the conveying device and the connecting piece can be made possible unhindered by the sealing element.

[0018] The body is connected to the radially outward-projecting flange. This projects outwards beyond the body. When the attachment is attached to the connecting piece, the flange is held or fixed in a clamped manner between the attachment and the connecting piece in such a way that the flange itself is not clamped. This indirect clamping of the flange is achieved in that the sealing element is supported with its shoulder on the one hand on the attachment and via its flange and / or the foot section on the other hand on the connecting piece. The underside of the flange simply rests on a support surface of the connecting piece and its upper side is exposed, preferably in sections or completely.The sealing element is thus fixed between the attachment part and the connecting piece via the flange, wherein the flange is preferably arranged at an end of the body facing away from the shoulder and thus the sealing element is supported with the shoulder on one side of the body and with the flange on the other side of the body relative to the attachment part and the connecting piece. The diameter of the sealing element is preferably larger at the flange than at the shoulder. The diameter of the flange is preferably in a range from 5 mm to 11 mm, more preferably from 7 mm to 9 mm. Because the flange itself is not held in a clamped manner, the sealing element still has a certain degree of mobility. As a result, when the syringe is connected, the sealing head can first be pushed from the connection piece of the syringe downwards into the housing. The side wall of the sealing element can thereby deflect radially.The sealing element can then be opened by inserting the syringe's connecting piece into a slotted opening in the sealing head. In particular, the radial compensating movement of the side wall can be supported by the movable arrangement of the flange.

[0019] In one embodiment, a radially outer section of the flange, when the attachment part is attached to the connecting piece, for example initially, can be held in a clamping manner between a bearing surface of the connecting piece and a projection of the attachment part that projects radially inwards into the opening. The projection is preferably an annular projection. The annular projection can extend completely or only partially over the circumference of the sealing element. The sealing element can thus be fixed, for example completely, within the opening via the annular projection, wherein the body can be held at a radial distance from the outer wall of the attachment part surrounding the opening via the annular projection that projects radially inwards into the opening. The annular projection can thus, on the one hand, bring about a section-by-section clamping of the sealing element between the attachment part and the connecting piece.In addition, the annular projection can support the (centered) position of the sealing element within the opening with a radial clearance from the wall of the attachment part surrounding the sealing element. In a further embodiment, the annular projection can also provide the connection between the connecting piece and the attachment part.

[0020] Preferably, the sealing element is convex on an outer side, which faces away from the connecting piece when the attachment part is attached to the connecting piece. However, it is also conceivable and possible for the sealing element to be essentially flat on the outer side or to be concavely curved inward.

[0021] In particular, in a state in which a conveying device can be connected to the attachment part, the outer side can protrude outwards beyond the attachment part or be flush with a surface of the attachment part, so that before the conveying device is attached, the outer side of the sealing element can be easily accessed from the outside and wiped or dabbed clean for the purpose of sterilization. The attachment part can have a break-off piece which, in an initial state, is integrally connected to another section of the attachment part connected to the connecting piece and which can be removed from this section, in particular broken off, in order to connect a conveying device to the attachment part. When the break-off piece is removed from the attachment part, the sealing element can protrude outwards with its outer side so that the outer side can be wiped or dabbed clean from the outside.The connection assembly and in particular the outer side of the sealing element can be provided sterile in the initial state, ie when the break-off piece has not yet been broken off.

[0022] The outer side is formed on the sealing head of the sealing element. For example, if a break-off piece is removed from the attachment, essentially only the outer side of the sealing element is exposed to the outside. This outer side protrudes outward, for example, in a convex manner and can be wiped or dabbed clean in a simple, reliable manner. The upper or outer side of the sealing head preferably has a diameter in a range of 3 mm to 7 mm, preferably 4 mm to 6 mm.

[0023] The shoulder is preferably arranged at an end of the sealing head facing away from the outside. The connector according to the invention does not include a hollow body with a tip intended to assist in opening the membrane. No body or hollow body with a tip is provided that is arranged inside the sealing element and intended to assist in opening the sealing head.

[0024] According to a further embodiment, viewed axially along the insertion direction (E), the sealing head is adjoined by a preferably cylindrical section which merges into the shoulder which projects radially outwards beyond the section. This section preferably has a larger diameter than the sealing head. Furthermore, again viewed axially along the insertion direction (E), the preferably cylindrical body can adjoin the shoulder, wherein the shoulder projects radially outwards beyond the body. In addition, the body can have a recess in its outer side at a transition to the flange, preferably provided by or as a step. In particular, there is only a single step in the body. This can assist the radial compensating movement of the sealing element when connecting the syringe, for example by a type of bulging.In cross-section, the recess may have a substantially straight bottom. For example, the recess may have a cuboid-like cross-section. In this case, the bottom and the radial opening of the recess may have substantially the same dimensions.

[0025] Viewed axially along the insertion direction, a foot section can be connected to the flange, which protrudes from the flange along the insertion direction and engages in an associated recess in the connecting piece when the attachment is attached to the connecting piece. This creates an advantageous connection between the sealing element and the connecting piece with a defined position of the sealing element within the opening of the attachment. The sealing element can thus be supported with the shoulder on one side of the body and with the flange and / or with the foot section on the other side of the body relative to the attachment and the connecting piece. The sealing element preferably has a total height in a range of 6 mm to 15 mm, more preferably 9 mm to 12 mm.

[0026] The sealing element preferably has a slotted opening on its sealing head, which, when the attachment part is attached to the connector, is closed against the passage of fluid. This slotted opening can be opened by connecting the delivery device to the attachment part, allowing a medical fluid to be conveyed through the slotted opening. Such a slotted opening thus creates a needle-free access, which, for example, can be used to access a container connected to the connector using a delivery device that does not have an injection needle.

[0027] For this purpose, the conveying device can be attached to the sealing element, for example, with a connecting piece, wherein the connecting piece preferably first pushes the top side of the sealing element downwards by applying pressure to the sealing element and then penetrates into the slotted opening, thus opening the sealing element to create a flow. The conveying device extends, at the latest when it is fully attached, for example screwed tight, preferably with the connecting piece, through the slotted opening of the sealing element, so that flow between the conveying device and the container can occur unhindered through the sealing element. In one embodiment, at least 80%, preferably at least 90%, of the opening cross-section in the conveying device through which the liquid is transported is exposed and thus not covered by the seal.Preferably, the entire cross-section of the opening in the conveying device through which the liquid is transported is exposed.

[0028] The attachment part is preferably formed in one piece as a plastic molded part, preferably as a plastic injection-molded part. The attachment part has a first section and a break-off piece. The opening into which the connecting piece engages when the attachment part is attached to the connecting piece is preferably formed in the first section. In an initial state, the break-off piece is connected to the first section and can be removed, in particular broken off, from the first section in order to connect a conveying device to the attachment part. The sealing element is held on the first section and, when the break-off piece is broken off, closes the opening of the first section to the outside. The outer side of the sealing element faces outwards and preferably projects outwards beyond the first section or is flush with the first section. In one embodiment, the attachment part provides a, preferably female, Luer connection.

[0029] In one specific embodiment, the first section is formed by a connecting section that can be attached to the connector and a threaded section that adjoins the connecting section. The threaded section has at least half a thread for establishing a threaded connection with the conveying device. Preferably, the threaded connection is provided by a double-start thread. In this way, a so-called Luer-Lock attachment is provided, with which a connecting element in the form of a union nut of a conveying device, for example a Luer-Lock syringe, can be connected to establish a Luer-Lock connection. In its initial state, the break-off piece is connected to the threaded section and thus closes off the attachment part to the outside.To connect the conveyor device to the attachment part, the break-off piece can be removed from the threaded section, in particular broken off, so that the conveyor device can be connected to the threaded section in a screwing manner with its connecting element.

[0030] In the initial state, the threaded portion and the break-off piece are advantageously connected to one another in one piece. A predetermined breaking point, e.g., in the form of a circumferential notch-shaped recess, can be provided between the threaded portion and the break-off piece, which allows for a defined removal of the break-off piece from the threaded portion along a line defined by the predetermined breaking point.

[0031] The sealing element preferably rests with its sealing head in an engagement opening of the threaded section such that essentially only the outer side of the sealing head is accessible from the outside. Particularly if the outer side protrudes beyond the threaded section or is flush with the top side of the threaded section, the sealing element can advantageously be wiped or dabbed from the outside on its outer side if the break-off piece is broken off, in order to attach a conveying device to the attachment part and connect it to the connecting piece under sterile conditions.

[0032] When the attachment part is attached to the connecting piece, the connecting piece preferably engages with a head in the opening of the attachment part. The connecting piece can advantageously be connected to the attachment part in a form-fitting manner, for example, by a form-fitting element running around the insertion direction, such as a circumferential annular projection, on the head of the connecting piece engaging with an associated form-fitting element on the attachment part side, thus axially securing the attachment part relative to the connecting piece. Additionally, one or more form-fitting elements can be provided on the head to ensure a rotationally fixed attachment of the attachment part to the head.For this purpose, for example, one or more webs extending parallel to the insertion direction and / or one or more grooves extending parallel to the insertion direction can be provided on the head, into which complementary form-locking elements on the side of the attachment part engage when the attachment part is attached to the connecting piece, so that the attachment part is fixed to the connecting piece in a rotationally fixed manner via this engagement.

[0033] The connection assembly and / or the sealing element can be part of a container for medical fluids. In this case, the connector is connected to the container and provides access to the container. A conveying device can be connected to the connector via the attachment part that can be attached to the connector and / or a connector that is integral with the connector and includes the sealing element, in order to convey a medical fluid into or out of the container.

[0034] Alternatively, the connection assembly can be part of a connector to which medical lines can be connected. For example, the connection assembly can be part of a so-called Y-connector, to which two lines and, via the attachment part, a conveyor device can be connected.

[0035] Furthermore, the scope of the invention also includes a sealing element for an embodiment of the connection assembly and / or the connector described above. The sealing element comprises a sealing head and a body adjoining the sealing head, wherein the sealing element has, at a transition between the sealing head and the body, a shoulder which projects radially beyond the sealing head in an insertion direction and which can be brought into contact with an associated contact surface within an opening of a connector along the insertion direction, and a flange which is spaced apart from the shoulder along the insertion direction, projects radially outward relative to the body of the sealing element and can be held in the connector, preferably in a clamping manner. The flange can rest with its underside on a head of the connection piece, and its upper side can be exposed at least in sections.In addition, a foot section, which, viewed axially along the insertion direction (E), adjoins the body below the flange, can engage in an associated recess in a head of the connecting piece when the attachment part is attached to the connecting piece. For possible embodiments of the sealing element, reference is made to the above description.

[0036] The invention also includes an arrangement comprising an embodiment of the connection assembly described above or an embodiment of the sealing element described above and a conveying device having a connecting piece for attachment to the attachment part, wherein, when the conveying device is attached to the attachment part, the connecting piece penetrates the slot opening of the sealing element. Embodiments:

[0037] 1. Connection assembly for conducting a medical fluid, comprising a connecting piece (11) through which a medical fluid can be conveyed, an attachment part (2) which can be attached to the connecting piece (11) and which can be connected to a conveying device (5) for conveying a medical fluid through the connecting piece (11), and a sealing element (4) for sealing a transition between the connecting piece (11, 12) and the attachment part (2) in such a way that, when the attachment part (2) is attached to the connecting piece (11), the sealing element (4) is held between the attachment part (2) and the connecting piece (11), wherein the sealing element (4) has a sealing head (40) which, when the attachment part (2) is attached to the connecting piece (11), closes an opening (210) of the attachment part (2) against the passage of fluid, and a body (42) adjoining the sealing head (40) which has a radial Distance from the attachment part (2) in the opening (210),and an interior of the sealing element (4) is free of a body with a tip intended to assist the opening of the sealing element (4), , characterized bythat the sealing element (4) at the transition between the sealing head (40) and the body (42) has a shoulder (410) which projects radially over the sealing head (40) in relation to the insertion direction (E) and which can be brought into contact with an associated contact surface (212) within the opening (210) of the attachment part (2) along the insertion direction (E), a flange (420) which is spaced apart from the shoulder (410) along the insertion direction (E) and projects radially outwards relative to the body (42) of the sealing element (4), which flange (420) is held between the attachment part (2) and the connection piece (11) when the attachment part (2) is attached to the connection piece (11) in such a way that the flange (420) rests with its underside (422) on a support surface (114) of the connection piece (11) and its upper side (421) is at least partially exposed, and a foot section (43) which, viewed axially along the insertion direction (E),below the flange (420) to the body (42) and, when the attachment part (2) is attached to the connecting piece (11), engages in an associated recess (113) in the connecting piece (11). 2. Connection assembly according to embodiment 1, , characterized by that the sealing element (4) is convex or flat on a side (400) facing away from the connecting piece (11) when the attachment part (2) is attached to the connecting piece (11). 3. Connection assembly according to embodiment 2, characterized by that the sealing head (40) carries the convex or flat side (400). 4. Connection assembly according to one of embodiments 1 to 3, characterized by that the flange (420) is arranged at an end of the body (42) facing away from the sealing head (40). 5. Connection assembly according to one of the preceding embodiments, characterized bythat the flange (420), when the attachment part (2) is attached to the connecting piece (11), is held in sections in a clamped manner between a support surface (114) of the connecting piece (11) and a projection (211), for example an annular projection (211), of the attachment part (21) projecting radially inward into the opening (210). 6. Connection assembly according to one of the preceding embodiments, characterized by that, viewed axially along the insertion direction (E), a preferably cylindrical section (41) adjoins the sealing head (40), which merges into the shoulder (410) that projects radially outward beyond the section (41). 7. Connection assembly according to one of the preceding embodiments, characterized bythat, viewed axially along the insertion direction (E), the preferably cylindrical body (42) adjoins the shoulder (410), wherein the shoulder (410) projects radially outwardly beyond the body (42). 8. Connection assembly according to one of the preceding embodiments, characterized by that the body (42) has a recess (423) in its outer side at a transition to the flange (420), preferably provided by a step. 9. Connection assembly according to one of the preceding embodiments, characterized by that the sealing element (4) has a slotted opening (45) which, when the attachment part (2) is attached to the connecting piece (11), is closed against the passage of liquid and can be opened by connecting the conveying device (5) to the attachment part (2) such that a medical liquid can be conveyed through the slotted opening (45). 10. Connection assembly according to one of the preceding embodiments, characterized bythat the attachment part (2) has a first section (21, 22) in which the opening (210) is formed, and a break-off piece (20) which, in an initial state, is connected to the first section (21, 22) and can be removed from the first section (21, 22) for connecting a conveyor device (5) to the attachment part (2). 11. Connection assembly according to embodiment 10, characterized by that the first section (21, 22) is formed by a connecting section (21) attachable to the connecting piece (11) and a threaded section (22) adjoining the connecting section (21), preferably with at least half a thread (220), for establishing a threaded connection with the conveyor device (5), wherein the break-off piece (20) is connected to the threaded section (22) in the initial state and is removable from the threaded section (22) for connecting the conveyor device (5) to the attachment part (2). 12. Connection assembly according to embodiment 11, characterized bythat the threaded portion (22) and the break-off piece (20) are formed in one piece, wherein a predetermined breaking point (200) is formed between the threaded portion (22) and the break-off piece (20) for breaking off the break-off piece (20) from the threaded portion (22). 13. Connection assembly according to embodiment 11 or 12, characterized by that the sealing element (4) lies in an engagement opening (221) of the threaded portion (22). 14. Connection assembly according to one of embodiments 11 to 13, characterized by that the sealing element (4) projects outwardly beyond an upper side (222) of the threaded portion (22) when the break-off piece is removed from the threaded portion (22) or is substantially flush with an upper side (222) of the threaded portion (22). 15. Connection assembly according to one of the preceding embodiments, characterized bythat the connecting piece (11) engages with a head (110) into the opening (210) of the attachment part (2) when the attachment part (2) is attached to the connecting piece (11) and / or that a form-locking element (115) is arranged on the head (110) and runs around the insertion direction (E), which, when the attachment part (2) is attached to the connecting piece (11), is in form-locking engagement with the attachment part (2) for axially fixing the attachment part (2) to the connecting piece (11). 16. Connection assembly according to embodiment 15, characterized bythat at least one web (116) extending parallel to the insertion direction (E) and / or at least one groove (117) extending parallel to the insertion direction (E) is arranged on the head (110) for rotationally fixing the attachment part (2) to the connecting piece (11). 17. Sealing element (4) for a connection assembly according to one of the preceding embodiments 1 to 16, comprising a sealing head (40) and a body (42) adjoining the sealing head (40), wherein the sealing element (4) has, at a transition between the sealing head (40) and the body (42), a shoulder (410) projecting radially beyond the sealing head (40) in an insertion direction (E), which shoulder can be brought into contact with an associated contact surface (212) within an opening (210) of a connector (2) along the insertion direction (E), a flange (420) spaced apart from the shoulder (410) along the insertion direction (E) and projecting radially outward relative to the body (42) of the sealing element (4),wherein the flange (420) rests with its underside (422) on a support surface (114) of the connecting piece (11) and its upper side (421) can be exposed at least in sections, and has a foot section (43) which, viewed axially along the insertion direction (E), adjoins the body (42) below the flange (420) and can engage in an associated recess (113) in the connecting piece (11) when the attachment part (2) is attached to the connecting piece (11). 18. Arrangement with a connection assembly according to one of the preceding embodiments 1 to 16 or with a sealing element (4) according to embodiment 17 and a conveyor device (5) which has a connection piece (51) for attachment to the attachment part (2), wherein when the conveyor device (5) is attached to the attachment part (2), the connection piece (51) penetrates the slot opening (45) of the sealing element (4).

[0038] The concept underlying the invention will be explained in more detail below with reference to the exemplary embodiments illustrated in the figures. They show: Fig. 1 shows a view of a container in the form of a bag with connecting pieces arranged thereon, to which attachments are attached; Fig. 2 shows an exploded view of the connecting pieces and the attachments with sealing elements to be arranged therebetween; Fig. 3 shows a separate view of a connecting piece with an attachment attached thereto; Fig. 4 shows a front view of the arrangement according to Fig. 3 ; Fig. 5 a sectional view in a cross-sectional plane corresponding to the plane of the drawing according to Fig. 4; Fig. 6 a separate view of an attachment part; Fig. 7 a separate view of a sealing element; Fig. 8A a front view of the connecting piece; Fig. 8B a side view of the connecting piece; Fig. 9 a view of the attachment part on the connecting piece, with the break-off piece broken off; Fig. 10 an enlarged view of the attachment part, with the break-off piece broken off; Fig. 11 the sectional view according to Fig. 5 , with the break-off piece broken off; Fig. 12A a schematic view of a conveyor device in the form of a syringe on the connecting piece; Fig. 12B a cross-sectional view of a conveyor device connected to the connecting piece (here in the form of a syringe); Fig. 13 a view of a connection assembly in the form of a Y-connector; and Fig. 14 an exploded view of the arrangement according to Fig. 13 .

[0039] Fig. 1shows a container 1 in the form of a flexible bag having a bag body 10 for containing a medical fluid, for example, a medication, a saline solution, a nutrient solution, or the like. The medical fluid can be stored in the container 1, and fluid can be poured into or removed from the container 1 via connectors 11, 12.

[0040] The connecting pieces 11, 12 provide access to the container 1. In the illustrated embodiment, a first connecting piece 11 is designed, together with an attachment part 2, to connect a conveying device 5 in the form of a syringe (see Fig. 12A and 12B) in order to convey a liquid component into the container 1 via the connecting piece 11. The second connecting piece 12, however, together with an attachment part 3, provides an access via which, for example, an infusion set can be connected to the container 1 in order to supply a liquid from the container 1 to a patient.

[0041] Fig. 2shows an exploded view of the connection assemblies formed by the connection pieces 11, 12, the attachments 2, 3, and the sealing elements 4, 6 to be arranged between the connection pieces 11, 12 and the attachments 2, 3. To produce the container 1, the connection pieces 11, 12 are placed between films and are welded to the films so that the connection pieces 11, 12 are integrally connected to the films. To complete the container 1, the attachments 2, 3 are attached to the connection pieces 11, 12 so that the sealing elements 4, 6 are located between the attachments 2, 3 and the connection pieces 11, 12, thus creating a liquid-tight seal between the attachments 2, 3 and the connection pieces 11, 12.

[0042] Each attachment part 2, 3 has a break-off piece 20, 30 that can be broken off to provide access to the container 1. Thus, the break-off piece 20 can be broken off from the attachment part 2 in order to connect a conveying device 5 in the form of a syringe to the attachment part 2 and to convey liquid into the container 1 via it. The break-off piece 30 can be broken off from the attachment part 3 in order, for example, to pierce an infusion set with a piercing spike through the sealing element 6 and to withdraw liquid from the container 1 via it, for example to administer the liquid to a patient.

[0043] Each attachment part 2, 3 also has a connecting section 21, 31 which can be brought into engagement with the associated connecting piece 11, 12 in order to thereby connect the respective attachment piece 2, 3 in a form-fitting manner with the associated connecting piece 2, 3.

[0044] The connector provided via the first connecting piece 11 and the attachment part 2 to be attached to it will be explained in detail below.

[0045] An embodiment of a connector comprising a connecting piece 11 and an attachment part 2 is shown Fig. 3 to 11 The connecting piece 11 is to be connected to the film of the container 1, as described above, and is thus held firmly between the films. The attachment part 2 can be attached to the connecting piece 11, so that in the attached position, the attachment part 2 is held in a form-fitting manner on the connecting piece 11.

[0046] The attachment piece 2 has a first section consisting of a connecting section 21 and an adjoining threaded section 22, and a break-off piece 20. The attachment piece 2 is formed as a single-piece plastic molding and, in an initial state, is present with the break-off piece 20 connected to the threaded section 22.

[0047] The connecting piece 11 has a flow opening 111 which, when the attachment part 2 is attached to the connecting piece 11, is closed off to the outside by the attachment part 2, so that no liquid can escape from the container 1 or into the container 1. When the attachment part 2 is attached, as can be seen from the sectional view according to Fig. 5As can be seen, the connecting piece 11 with a head 110 fits into an opening 210 of the connecting section 21 and is connected axially via a circumferential form-locking element in the form of an annular projection 115 and in a rotationally fixed manner to the attachment part 2 via form-locking elements 116, 117 in the form of axially extending webs and grooves. Within the opening 210 of the connecting section 21 of the attachment part 2, complementary form-locking elements are formed, for example in the form of an annular recess for engagement with the circumferential form-locking element 115 and in the form of axially extending webs and / or grooves for engagement with the webs 116 and grooves 117.

[0048] When the attachment part 2 is attached to the connecting piece 11, the sealing element 4 comes to lie between the attachment part 2 and the connecting piece 11 and is held clamped between the attachment part 2 and the connecting piece 11. The sealing element 4 can be inserted in an insertion direction E into the opening 210 within the attachment part 2 (see Fig. 6 ). The sealing element 4 is, as shown in Fig. 7 shown, is designed as a rotationally symmetrical body and has a sealing head 40 which comes to rest in an engagement opening 221 of the threaded portion 22 and protrudes with a convexly curved or flat side 400 beyond the threaded portion 22 in the direction of the break-off piece 20. However, the side 400 can also be substantially flush with the top side of the threaded portion 22.

[0049] Adjoining the sealing head 40 is a cylindrical portion 41, which transitions into a shoulder 410. When the sealing element 4 is inserted into the opening 210, the shoulder rests against a circumferential, conical contact surface 212 at the inner transition between the connecting portion 21 and the threaded portion 22 of the attachment part 2. The cylindrical portion 41 has a larger diameter than the sealing head 40.

[0050] Adjoining the shoulder 410, which projects radially outward beyond the section 41 and encircles the sealing element 4, is a cylindrical body 42 which fits with clearance into the opening 210 of the connecting section 21. The cylindrical body 42 has a smaller diameter here than the shoulder 410. Because this body 42 fits into the opening 210 at a radial distance from the circumferential wall of the connecting section 21, the sealing element 4 can be advantageously deformed when a conveying device 5 is attached, in order to create a flow through the sealing element 4 between the conveying device 5 and the container 1.

[0051] At an end facing away from the sealing head 40, the body 42 carries a circumferential flange 420. The underside 422 of the flange 420 rests on a support surface 114 of the connecting piece 11. Its upper side 421 can be completely exposed. In this case, the upper side 421 is not covered. It is not in contact with or engaged with a corresponding component. For example, the upper side 421 is not covered by a clamping surface of the connecting piece 2. However, the upper side 421 of the flange 420 can also be exposed only in sections. In this embodiment, when the attachment part 2 is attached to the connecting piece 11, the flange 420 can come to rest in sections between an annular projection 211 of the connecting section 21 and a support surface 114 on the head 110 of the connecting piece 11 and can thus be held in a clamped manner between the annular projection 211 and the support surface 114.A radially outer section of the flange 420 is held in a clamped manner.

[0052] Above the flange 420 or at a transition to the flange 420, the cylindrical body 42 has a recess 423 in its outer side. This can assist the deformation of the sealing element 4 when attaching a conveyor device 5. The recess 423 is provided by a step in the outer side. In cross-section, the recess 423 has a substantially straight bottom. For example, the recess 423 has a cuboid-like cross-section. The bottom and the radial opening of the recess 423 can have substantially the same dimensions (seen in the insertion direction E).

[0053] The flange 420 is adjoined by a foot section 43 which engages in a recess 113 on the head 110 of the connecting piece 11.

[0054] In the attached position, the attachment part 2 rests on the front side against an outer flange 112 of the connecting piece 11.

[0055] Because the sealing element 4 is supported with the shoulder 410 on the one hand on the attachment part 2 and via its flange 420 and the foot section 113 on the other hand on the connecting piece 11, a defined, secured position of the sealing element 4 within the opening 210 of the attachment part 2 is ensured. By means of a cylindrical, inner opening 44, which extends through the body 42 and the cylindrical section 41 of the sealing element 4, starting from the foot section 43 up to the sealing head 40 and is in flow connection with a tapered flow section 118 of the connecting piece 111, a high flow rate can be achieved between the conveying device 5 and the container 1 when the conveying device 5 is attached to the attachment part 2. The inner opening 44 preferably has a diameter in a range of 1 mm to 5 mm, more preferably 2 mm to 4 mm.

[0056] In an initial state, shown in Fig. 5, the attachment part 2 is attached to the connecting piece 11 together with the sealing element 4, so that the connecting piece 11 is closed to the outside. In this initial state, the sealing element 4 is not accessible from the outside because the upper side 400 of the sealing head 40 in the opening 221 of the threaded section 22 is covered to the outside by the break-off piece 20.

[0057] The break-off piece 20 is connected to the threaded portion 22 via a predetermined breaking point 200 in the form of a notch-like, circumferential recess. In order to connect a conveying device 5, for example in the form of a syringe, to the attachment part 2 and thus create access to the container 1 for filling a liquid, a user can break the break-off piece 20 from the threaded portion 22 by grasping a gripping element 201 of the break-off piece 20 with his fingers and detaching the break-off piece 20 from the threaded portion 22, as shown in Fig. 9When the break-off piece 20 is removed, the attachment part 2 is thus without the break-off piece 20, as shown in Fig. 10 is shown.

[0058] After breaking off the break-off piece 20, the sealing element 4 is exposed with its outward-facing, for example, convex or flat, side 400 on the sealing head 40, so that this outward-facing side 400 can be accessed from the outside. In an embodiment in which the side 400 is convex and protrudes outward in a curved manner beyond an upper side 222 of the threaded portion 22, the sealing element 4 can be conveniently wiped or dabbed on this side 400 in order to clean and disinfect the sealing element 4—in accordance with any applicable legal requirements. A flat side 400 can also be wiped or dabbed accordingly.

[0059] Then, as in Fig. 12A and 12Bshown, a conveying device 5 in the form of a syringe is attached to the threaded section 22 by screwing a connecting element 50 in the form of a nut or union nut of the conveying device 5 into engagement via threads 500 with threads 220 on the threaded section 22. As a result, a connecting piece 51 of the conveying device 5 is inserted into the engagement opening 221 on the threaded section 22, so that the connecting piece 51 presses on the sealing head 40 of the sealing element 4, initially pressing it downwards and then at the slot opening 45 (see Fig. 11 ) opens. The connecting piece 51 thus penetrates the sealing head 40 at the slotted opening 45 and comes into flow connection with the cylindrical opening 44, so that a flow is provided between the conveying device 5 and the flow opening 111 of the connecting piece 11.

[0060] When the connecting piece 51 is pressed into the engagement opening 221, the sealing head 40 is also pressed into the attachment part 2 and, together with the remaining sections 41, 42, is pushed aside into the space available radially outside the section 42. When the connecting piece 51 is fully inserted, the connecting piece 51 engages positively in the engagement opening 221 and passes through the sealing head 40, creating a favorable flow connection between the connecting piece 51 and the flow opening 118 on the head 110 of the connecting piece 11, which is not or only insignificantly impaired by the sealing element 4.The conveying device 5 extends, at the latest in the fully attached state, here, for example, when screwed tight, with its connecting piece 51 through the slotted opening 45 of the sealing element 4, so that a flow between the conveying device 5 and the container 1 can occur unhindered or essentially unhindered by the sealing element 4. Preferably, as shown, the entire opening cross-section in the conveying device 5, through which the liquid is transported, is exposed.

[0061] The conveying device 5 has a syringe body 52 and a plunger 53 which can be pushed into the syringe body 52 in order to convey a liquid from the syringe body 52 into the container 1.

[0062] Because a slotted opening 45, for example, a cross-shaped or straight one, is provided in the sealing head 40 of the sealing element 4, a needle-free access is created, which can be accessed using a delivery device 5 without an injection needle. When the delivery device 5 is attached, the connecting piece 51 engages the slotted opening 45 and thus opens the sealing element 4, creating a flow between the delivery device 5 and the container 1.

[0063] After removal of the conveying device 5 from the attachment part 2, the sealing element 4 closes automatically and self-sealingly so that no liquid can escape from the container 1.

[0064] Figs. 13 and 14 show a further embodiment in which a connection assembly consisting of a connection piece 11, an attachment part 2 arranged thereon and a sealing element 4 is used.

[0065] In this case, the connection assembly is part of a connector 7 in the form of a so-called Y-connector. The connector 7 has two line connections 70, 71, to each of which a medical line in the form of an infusion tube or the like can be connected. The line connections 70, 71 are in fluid communication with the connector 11 at a connection point 72, so that a medical fluid can be introduced into a line system connected to the line connections 70, 71 or withdrawn from the line system via the connector 11.

[0066] In this embodiment, an attachment part 2 is arranged on the connecting piece 11. A sealing element 4 is clamped between the attachment part 2 and the connecting piece 11. As in the embodiment according to Fig. 1 to 12A break-off piece 20 is connected to the threaded section 22 of the attachment part 2, which can be broken off in order to form a conveyor device 5 (see Fig. 12 ) to the threaded portion 22 and to connect the conveyor device 5 to the connecting piece 11 via it. Because the sealing element 4 can protrude outwardly beyond the top side 222 of the threaded portion 22 with a convex side 400 and is thus easily accessible from the outside, the sealing element 4 can be conveniently wiped on its side 400 before connecting the conveyor device 5 in order to disinfect the sealing element 4 on its outward-facing side 400. A flat side 400 can also be wiped or dabbed accordingly.

[0067] Both the connecting piece 11 and the attachment part 2 are identical in their design and function as described above for the embodiment according to Fig. 1 to 12B, so reference should be made to the preceding statements.

[0068] The idea underlying the invention is not limited to the embodiments described above, but can also be implemented in a completely different way. List of reference symbols

[0069] 1Bag 10Bag body 11, 12Connecting piece 110, 120Head 111Flow opening 112Flange 113Recess 114Support surface 115Form-locking element (annular projection) 116Web 117Groove 118Flow opening 2Attachment 20Break-off piece 200Predetermined breaking point 201Grip element 21Connecting section 210Opening 211Annular projection 212Support surface 22Threaded section 220Threads 221Engagement opening 222Top side 3Attachment 30Break-off piece 31Connecting section 4Sealing element 40Sealing head 400Convex or flat side 41Section 410Shoulder 42Body 420Flange 421Top of the flange 422Bottom of the flange 423Recess or step in the outside of the sealing element or the body 42 43Foot section 44Opening 45Slot opening 5Conveying device (syringe) 50Connecting element 500Threads 51Connecting nozzle (syringe cone) 52Syringe body 53Stamp 6Sealing element 7Connector 70, 71Pipe connection 72Connection point EInsertion direction

Claims

1. A sealing element (4) for a container for a medical liquid, comprising a sealing head (40) and a body (42) adjoining the sealing head (40), wherein the sealing element (4) - at a transition between the sealing head (40) and the body (42) has a shoulder (410) which projects radially beyond the sealing head (40) in an insertion direction (E) and which can be brought into contact with an associated contact surface (212) within an opening (210) of a connector (2) along the insertion direction (E), - a flange (420) which is spaced apart from the shoulder (410) along the insertion direction (E) and projects radially outward relative to the body (42) of the sealing element (4), and - a foot section (43) which, viewed axially along the insertion direction (E), adjoins the body (42) below the flange (420).

2. Sealing element (4) according to claim 1, characterized in that the sealing element (4) is convex or flat on one side (400).

3. Sealing element according to claim 2, characterized in that the sealing head (40) carries the convex or flat side (400).

4. Sealing element (4) according to one of claims 1 to 3, characterized in that the flange (420) is arranged at an end of the body (42) facing away from the sealing head (40).

5. Sealing element (4) according to one of the preceding claims, characterized in that viewed axially along the insertion direction (E), the sealing head (40) is adjoined by a preferably cylindrical section (41) which merges into the shoulder (410) which projects radially outwards beyond the section (41).

6. Sealing element (4) according to one of the preceding claims, characterized in that viewed axially along the insertion direction (E), the preferably cylindrical body (42) adjoins the shoulder (410), the shoulder (410) projecting radially outwards beyond the body (42).

7. Sealing element (4) according to one of the preceding claims, characterized in thatthe body (42) has a recess (423) in its outer side at a transition to the flange (420), preferably provided by a step.

8. Sealing element (4) according to one of the preceding claims, characterized in that the sealing element (4) has a slotted opening (45) which is closed against the passage of liquid and can be opened by connecting the conveying device (5) in such a way that a medical liquid can be conveyed through the slotted opening (45).

9. Sealing element (4) according to one of the preceding claims, characterized in that a diameter of the sealing element (4) in the region of the shoulder (410) is in a range from 4 mm to 10 mm, preferably from 6 mm to 8 mm, and / or that the sealing element (4) has a total height in a range from 6 mm to 15 mm, preferably from 9 mm to 12 mm.

10. A connecting piece (11) through which a medical fluid can be conveyed, for connecting to films of a container (1), comprising a head (110) with a flow opening (118) and with a recess (113) for receiving a foot section (43) of a sealing element (4) according to one of the preceding claims 1 to 9.

11. Connecting piece (11) according to claim 10, characterized in that the head (110) comprises a circumferential form-locking element in the form of an annular projection (115) and form-locking elements (116, 117) in the form of axially extending webs and grooves.

12. Connecting piece (11) according to one of the preceding claims 10 to 11, characterized in that at least one web (116) extending parallel to the insertion direction (E) and / or at least one groove (117) extending parallel to the insertion direction (E) is arranged on the head (110) for rotationally fixing an attachment part (2) to the connecting piece (11).

13. Attachment part (2) comprising a first section (21, 22) in which an opening (210) is formed, and a break-off piece (20) which, in an initial state, is connected to the first section (21, 22) and can be removed from the first section (21, 22) for connecting a conveyor device (5) to the attachment part (2), wherein a connecting piece according to one of the preceding claims 10 to 12 engages in the opening (210) when the attachment part (2) is attached to the connecting piece (11), and wherein, when the attachment part (2) is attached to the connecting piece (11), a sealing element (4) according to one of the preceding claims 1 to 10 is held in a clamping manner between the attachment part (2) and the connecting piece (11), so that a transition between the attachment part (2) and the connecting piece (11) is sealed in a liquid-tight manner.

14. A connection assembly for conducting a medical fluid, comprising a connection piece (11) according to one of the preceding claims 10 to 12, an attachment part (2) attached to the connection piece (11) according to the preceding claim 13 and a sealing element (4) according to one of the preceding claims 1 to 9 for sealing a transition between the connection piece (11, 12) and the attachment part (2).

15. Arrangement with a sealing element (4) according to one of the preceding claims 1 to 10 or with a connection assembly according to claim 14 and a conveyor device (5) which has a connection piece (51) for attachment to the attachment part (2), wherein when the conveyor device (5) is attached to the attachment part (2), the connection piece (51) penetrates the slot opening (45) of the sealing element (4).

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