EP3297596A1

EP3297596A1 - Connection assembly for conducting a medical liquid

Info

Publication number: EP3297596A1
Application number: EP16727339.0A
Authority: EP
Inventors: Torsten Brandenburger
Original assignee: Fresenius Kabi Deutschland GmbH
Current assignee: Fresenius Kabi Deutschland GmbH
Priority date: 2015-05-22
Filing date: 2016-05-23
Publication date: 2018-03-28
Also published as: HK1247551A1; US10576019B2; BR112017022203B1; CA2986496C; MX2017014876A; KR102593070B1; AU2016266694A1; ZA201707390B; CN107645948B; JP2018515266A; US20180092807A1; JP2023156446A; WO2016188957A1; AU2016266694B2; CL2017002968A1; BR112017022203A2; US20180153770A1; CA2986496A1; CN107645948A; JP2021072934A

Abstract

The invention relates to a connection assembly for conducting a medical liquid, comprising a connection piece (11) through which a medical liquid can be pumped; an attachment part (2) which can be attached to the connection piece (11) and which can be connected to a pump device (5) for pumping a medical liquid through the connection piece; an opening (210) into which the connection piece (11) engages when the attachment part (2) is attached to the connection piece (11); and a seal element (4) for sealing a passage between the connection piece (11, 12) and the attachment part (2). The seal element (4) can be inserted into the opening (210) of the attachment part (2) in an insert direction (E) such that the seal element (4) is held between the attachment part (2) and the connection piece (11) when the attachment part (2) is attached to the connection piece (11). The seal element (4) has a sealing head (40), which closes the opening (210) of the attachment part (2) against the passage of liquid when the attachment part (2) is attached to the connection piece (11), and a body (42), which adjoins the sealing head (40) and which can be arranged in the opening (210) at a radial distance to the attachment part (2). The interior of the seal element (4) is free of a tipped body, which should aid the opening process of the sealing head (40). The seal element (4) has a shoulder (410), which projects beyond the sealing head (40) radially to the insert direction (E) and which can be brought into contact with a paired contact surface (212) within the opening (210) of the attachment part (2) along the insert direction (E), at the transition between the sealing head (40) and the body (42); a flange (420) which is arranged at a distance from the shoulder (410) along the insert direction (E), projects radially outwards with respect to the body (42) of the seal element (4), and is held between the attachment part (2) and the connection piece (11) when the attachment part (2) is attached to the connection piece (11) such that the lower face (422) of the flange (420) rests on a support surface (114) of the connection piece (11) and the upper face (421) of the flange is at least partly exposed; and a foot portion (43) which engages into a paired recess (113) in the connection piece (11) when the attachment part (2) is attached to the connection piece (11). In this manner, a medical liquid-conducting connection assembly can be provided which allows a reliable hold of the seal element between the connection piece and the attachment part.

Description

Terminal assembly for conducting a medical fluid

description

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

Such a connection assembly can be used, for example, on a container for medical liquids, for example in the form of a flexible bag, an ampoule or another bottle container, for conducting a medical liquid into the container or removing it from the container. Such a connection module can also be called a connector for short,

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

In a connector known from WO 2010/034470 A1, a hollow body with a tip is arranged on one side of a membrane, which faces away from a syringe to be attached to the membrane. The hollow body helps to open the membrane. When attaching the syringe to the connector, the membrane is pushed by the syringe onto the tip of the hollow body so that the syringe engages the hollow body and thus allows flow through the membrane and the hollow body.

A valve unit having a hollow body which facilitates opening of the membrane is also shown in WO 93/11828 A1. The document shows a needle-free valve assembly having a tubular body defining an internal cavity.

The valve unit also includes a hollow spike disposed in the cavity with a closed tip. The valve unit further comprises an elastic

Silicone gasket, which closes the valve unit and covers the tip of the spike. The seal has a sealing head, a conical sidewall and a lower one

Sealing lip. The lower sealing lip is clamped between an annular

Cuff and the bottom of a ring held.

Such connectors serve, for example, to provide so-called needle-free access to a container containing a medical fluid, for example a bag or a bottle, in order to fill or remove fluid from the container via the access. Such a needle-free access allows access to the container using a conveyor that has no injection needle. Instead, for example, a connecting piece of a conveyor in the form of a syringe is attached to a slot opening of a sealing element, in order to open the slot opening in this way and to allow a flow between the conveyor and the container.

By using needle-free access, in particular, the risk of injury that would otherwise exist when using injection needles can be reduced. Even if the sealing element is already provided sterile, legal requirements may be required to wipe or dab the sealing element on its outside before connecting a conveyor to the attachment part. This is intended to ensure access, for example to a container, under sterile conditions. Such spillable or wipeable connectors are known, for example, from EP 1 470 352 B1 and EP 1 217 284 B1.

US 2010/0298782 A1 describes an intravascular valve component which has a valve housing and a flexible, pressure-operable flow control valve. The housing includes a near and a remote housing part, which are interconnected. The valve comprises 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 restrict radial movement of the valve relative to the housing.

Object of the present invention is to provide a connector assembly for guiding a medical fluid available, which allows a reliable hold, but also a certain mobility of the sealing element. In particular, the flow should not be significantly affected. A further object is to provide a terminal assembly in which a wiping or dabbing of a sealing element for the purpose of disinfection is made possible in a simple manner.

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

It is a connector assembly for conducting a medical fluid. It comprises a connecting piece through which a medical fluid can be conveyed. and an attachment member attachable to the fitting, connectable to a delivery device for delivering a medical fluid through the fitting. Preferably, the attachment piece has an opening into which the connector engages when attached to the connector Ansetzteil. The terminal assembly also includes a sealing element for sealing a transition between the fitting and the attachment part. Preferably, the sealing element can be used in an insertion direction into the opening of the Ansetzteils such that when attached to the connector Ansetzteil the sealing element between the Ansetzteil and the connector is held. In particular, an interior of the sealing element is free of a body with a tip, which is to assist the opening of the sealing element. The sealing element has a sealing head, which closes the opening of the Ansetzteils against a liquid passage when attached to the fitting Ansetzteils, and a subsequent to the sealing head body, which can be arranged or arranged with radial distance to Ansetzteil in the opening.

The sealing element has

- At the transition between the sealing head and the body a radially to the insertion direction on the sealing head projecting shoulder, which can be brought along the insertion in abutment with an associated contact surface within the opening of Ansetzteils, and

a flange which is spaced apart from the body of the sealing element and extends radially outwards along the direction of insertion to the shoulder, which is held between the attachment part and the connecting piece when the attachment part is attached to the connection piece, preferably by clamping

on.

The sealing element is held at attached to the fitting Ansetzteil so between the Ansetzteil and the connector so that the flange rests with its underside on a support surface of the connector and its upper side at least partially exposed. The sealing element comprises a foot section which, viewed axially along the insertion direction (E), adjoins the body below the flange and engages in an associated recess in the connection piece when the attachment part is attached to the connection piece.

The sealing element is held in clamped manner when attached to the fitting Ansetzteil between the Ansetzteil and the connector, so that a transition between the Ansetzteil and the connector is sealed in liquid-tight manner. The sealing element in this case has a circumferential around the direction of insertion around the shoulder, which projects radially outwardly beyond the sealing head and - rests on an attached contact surface of the Ansetzteils - attached to the fitting Ansetzteil. Over the shoulder, the sealing element is thus supported in particular axially along the insertion direction relative to the Ansetzteil, so that over the shoulder, the sealing element is fixed axially relative to Ansetzteil. Preferably, the diameter of the sealing element in the region of the shoulder in a range of 4 mm to 10 mm, preferably from 6 mm to 8 mm. Characterized in that the sealing element is supported with the shoulder on the one hand on Ansetzteil and on its flange and the foot portion on the other hand on the connector, a defined, secured position of the sealing element can be ensured within the opening of Ansetzteils.

To the shoulder of the closes - in particular cylindrically shaped - body of the sealing element. The sealing element has a total of preferably a rotationally symmetrical shape, wherein different portions of the sealing element may have different diameters. The shoulder adjoining body is disposed in the opening of the attachment part with radial play, so that there is a space around the body within the opening of the attachment part into which the sealing element can deform when a delivery device is attached to the attachment part. Because thus radially outward to the wall of the Ansetzteils out there is space in the opening into which the sealing element can be pushed aside, when a conveyor, such as a syringe is attached with a connecting piece to the sealing element, a slot opening on the sealing head of the sealing element be opened in a reliable manner and in the open state, a flow between the conveyor and the connector are made possible unhindered by the sealing element.

The body is adjoined by the radially outwardly projecting flange. This protrudes outward over the body. When attached to the connector Ansetzteil the flange is clamped or clamped between the Ansetzteil and the connector so that the flange itself is not clamped. This indirect clamping holder of the flange is achieved in that the sealing element is supported with the shoulder on the one hand on Ansetzteil and on its flange and / or the foot portion on the other hand on the connector. The flange lies with its underside on a support surface of the connector only on and its top is, preferably in sections or completely, free. The flange is thus used to fix the sealing element between the attachment part and the connection piece, wherein the flange is preferably arranged on an end of the body facing away from the shoulder and thus the sealing element with the shoulder on one side of the body and with the flange on the other Side of the body relative to the Ansetzteil and the connection piece is supported. Preferably, the diameter of the sealing element is greater at the flange than at the shoulder. Preferably, the Diameter of the flange in a range of 5 mm to 1 1 mm, preferably from 7 mm to 9 mm. The sealing element has the fact that the flange itself is not held by clamping yet a certain mobility. As a result, when connecting the syringe, the sealing head can first be pushed downwards into the housing from the connection nozzle of the syringe. The side wall of the sealing element can dodge radially. Then, the sealing element can be opened by the connection piece of the syringe penetrates into a slot opening in the sealing head. In particular, the radial compensation movement of the side wall can be supported by the movable arrangement of the flange.

In one embodiment, a radially outer portion of the flange may be held clamped between an abutment surface of the fitting and a protrusion of the attachment part projecting radially inwardly when the attachment part is attached to the attachment piece, for example initially. Preferably, the projection is an annular projection. The annular projection may extend completely or only in sections over the circumference of the sealing element. By way of the annular projection, the sealing element can thus be fixed, for example completely, within the opening, wherein the body can be held at a radial distance from the outer wall of the attachment part surrounding the opening by way of the radially inwardly projecting annular projection into the opening. The annular projection can thus effect, on the one hand, a section-wise clamping fixing 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 spacing of the wall of the attachment part surrounding the sealing element. In a further embodiment, the connection between the connection piece and the attachment part can also be provided via the annular projection.

Preferably, the sealing element is convex on an outer side, which faces away from the connection piece when the attachment part is attached to the connection piece. It is also conceivable and possible, however, that the sealing element is curved on the outside substantially flat or concave inwards.

The outer side can in particular in a state in which a conveyor is connectable to the Ansetzteil beyond the Ansetzteil outwardly projecting or be flush with a surface of Ansetzteils, so that before applying the conveyor readily on the outside of the sealing element from the outside accessed and wiped or blotted for sterilization purposes can. The attachment part may in this case have a Abbrechstück, which is connected in an initial state integral with another, connected to the connector portion of Ansetzteils and removed from this section, in particular can be canceled to connect a conveyor with the Ansetzteil. When removed from the Ansetzteil Abbrechstück the sealing element may protrude with its outside to the outside, so that the outside can be wiped or dabbed from the outside. The connection assembly, and in particular also the outside of the sealing element, can already be provided in a sterile state in the initial state, ie, if the break-off piece has not yet been broken off.

The outside is formed on the sealing head of the sealing element. If, for example, a break-off piece is removed from the attachment part, essentially only the outside of the sealing element is exposed to the outside, which, e.g. protrudes outward in a convexly curved manner and can be wiped off or dabbed in a simple, reliable manner. Preferably, the upper or outer side of the sealing head has a diameter in a range of 3 mm to 7 mm, preferably 4 mm to 6 mm.

The shoulder is preferably arranged on a side facing away from the outside end of the sealing head. In the connector according to the invention no hollow body is provided with a tip to assist the opening of the membrane. There is no body or hollow body provided with a tip which is arranged in the interior of the sealing element and should assist in opening the sealing head. According to another embodiment, viewed axially along the direction of insertion (E), the sealing head is adjoined by a preferably cylindrical portion which merges into the shoulder projecting radially outwards over the portion. Preferably, this section has a larger diameter than the sealing head. Further, viewed again axially along the direction of insertion (E), the body may be joined to the shoulder, preferably cylindrically shaped, with the shoulder projecting radially outwardly beyond the body. Additionally, at a transition to the flange, the body may have a recess in its outside, preferably provided by or as a step. In particular, there is only a single step in the body. As a result, the radial compensation movement of the sealing element when connecting the syringe, for example, by a kind of bulging, be supported. In cross section, the recess may have a substantially straight bottom. For example, the recess of a cuboid cross-section exhibit. The bottom and the radial opening of the recess may in this case have substantially the same dimensions.

As viewed axially along the direction of insertion, the flange may be adjoined by a foot portion projecting from the flange along the direction of insertion and engaging an associated recess of the fitting with an attachment portion attached to the fitting. It is thus created an advantageous connection between the sealing element and the connecting piece with a defined position of the sealing element within the opening of the Ansetzteils. 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 portion on the other side of the body relative to the Ansetzteil and the fitting. Preferably, the sealing element has an overall height in a range of 6 mm to 15 mm, preferably 9 mm to 12 mm. The sealing element preferably has at its sealing head a slot opening, which closed when attached to the fitting Ansetzteil against a liquid passage and to open by connecting the conveyor to the Ansetzteil is such that a medical fluid can be conveyed through the slot opening. By means of such a slot opening thus a needle-free access is provided, by means of which, using a conveyor which has no injection needle, for example, can be accessed on a connected to the connector container.

For this purpose, the delivery device can be attached to the sealing element, for example with a connection piece, the connection piece preferably first pushing down the upper side of the sealing element by pressure on the sealing element and then penetrating into the slot opening and thus opening the sealing element to create a throughflow. The conveyor extends at the latest when it is completely attached, for example, screwed, is, preferably with the connection piece, through the slot opening of the sealing element, so that a flow between the conveyor and the container can be done freely by 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 transport takes place is released and thus not covered by the seal. Preferably, the entire cross section of the opening in the conveyor, through which the liquid transport takes place, is released. The attachment part is preferably integrally formed as a plastic molded part, preferably as a plastic injection molded part. The Ansetzteil here has a first portion and a Abbrechstück. Preferably, in the first portion, the opening is formed, in which engages when attached to the fitting Ansetzteil the connector. The Abbrechstück is connected in an initial state with the first portion and can be for connecting a conveyor to the Ansetzteil of the first section removed, in particular broken off. The sealing element is held on the first portion and closes when broken Abbrechstück the opening of the first section to the outside. In this case, the outside of the sealing element faces outward and is preferably projecting outwardly beyond the first section or is flush with the first section. In one embodiment, the attachment portion provides a, preferably female, luer fitting. The first section is formed in a concrete embodiment by a connecting portion attachable to the connecting portion and a subsequent to the connecting portion threaded portion. The threaded portion has at least half a thread for making a threaded connection with the conveyor. Preferably, the threaded connection is provided by a double-threaded. In this way, a so-called Luer-lock approach is provided with which a connection element in the form of a union nut of a conveyor, such as a Luer-lock syringe, can be connected to produce a Luer-lock connection. In its initial state, the Abbrechstück is connected to the threaded portion and thus closes off the Ansetzteil outwards. To connect the conveyor with the Ansetzteil the Abbrechstück can be removed from the threaded portion, in particular be canceled, so that the conveyor can be brought in a screwing manner with its connection element with the threaded portion in connection. The threaded portion and the Abbrechstück are in the initial state advantageously integrally and integrally connected. Between the threaded portion and the Abbrechstück here a Sollbrechstelle, for example in the form of a circumferential notch-shaped depression, be provided which allows a defined removal of the Abbrechstücks of the threaded portion along a predetermined line by the predetermined breaking point. The sealing element is preferably located with its sealing head in an engagement opening of the threaded portion in such a way that substantially only the outside of the sealing head is accessible from the outside. In particular, when the outside projects beyond the threaded portion to the outside or flush with the top of the threaded portion, the sealing element can advantageously be wiped or dabbed on its outside with broken Abbrechstück on the outside to attach a conveyor under sterile conditions to the attachment part and to connect with the fitting. The connection piece preferably engages with a head attached to the attachment part with a head in the opening of the Ansetzteils. The connecting piece can advantageously be positively connected to the Ansetzteil by, for example, a rotating around the insertion direction positive locking element, for example, a circumferential annular projection at the head of the connector with an associated positive locking element on the side of the Ansetzstücks engaged and in this way the Ansetzteil relative to the connector axially sets. In addition, one or more positive locking elements can be provided on the head, which effect a rotationally fixed fixing of the attachment part on the head. For this purpose, one or more parallel to the insertion direction extending webs and / or one or more parallel to the insertion direction provided grooves may be provided on the head, engage in the attached to the connector Ansetzem associated complementary interlocking elements on the side of the Ansetzteils, so that on this engagement the Ansetzteil is fixed in a rotationally fixed manner to the connector. The connection assembly and / or the sealing element may be part of a container for medical fluids. In this case, the connector is connected to the container and provides access to the container. By means of the attachable part attachable to the connecting piece and / or a connector integral with the connecting piece, which comprises the sealing element, a conveying device can be connected to the connecting piece in order to convey a medical liquid into or out of the container.

Alternatively, the connector assembly may be part of a connector to which medical leads may be connected. For example, the terminal assembly may be part of a so-called Y-connector, to the two lines and on the Ansetzteil also a conveyor can be connected. Furthermore, within the scope of the invention is also a sealing element for an embodiment of the above-described 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 at a transition between the sealing head and the body a radially projecting to a direction of insertion via the sealing head shoulder along the insertion in abutment with an associated contact surface within an opening of a Connector can be brought, and a along the direction of insertion to the shoulder spaced, with respect to the body of the sealing element radially outwardly projecting flange, which preferably can be clamped, held in the connector comprises. The flange can rest with its underside on a head of the connector and its top can at least partially exposed. In addition, a foot portion, which, viewed axially along the insertion direction (E), below the flange adjoins the body, engage with an attachment attached to the fitting in an associated recess in a head of the fitting. For possible embodiments of the sealing element, reference is made to the above description.

In the context of the invention is also an arrangement which comprises an embodiment of the above-described connection assembly or an embodiment of the sealing element described above and a conveyor having a connecting piece for attachment to the Ansetzteil, wherein attached to the Ansetzteil conveyor, the connecting piece, the slot opening of Sealing element penetrates.

The idea underlying the invention will be explained in more detail with reference to the embodiments illustrated in the figures. Show it:

Figure 1 is a view of a container in the form of a bag with connectors arranged thereon, are attached to the Ansetzteile.

2 shows an exploded view of the connecting pieces and the attachment parts with sealing elements to be arranged therebetween; Fig. 3 is a separate view of a connector with an attached thereto

added element; Fig. 4 is a front view of the arrangement of FIG. 3;

Fig. 5 is a sectional view in a cross-sectional plane corresponding to

Drawing plane according to Fig. 4;

Fig. 6 is a separate view of a Ansetzteils;

Fig. 7 is a separate view of a sealing element; Fig. 8A is a front view of the fitting;

Fig. 8B is a side view of the fitting;

Fig. 9 is a view of the attachment part on the connector, in aborted

Abbrechstück;

10 is an enlarged view of Ansetzteils, broken off Abbrechstück.

Fig. 1 1 is the sectional view of Figure 5, broken off Abbrechstück.

Fig. 12A is a schematic view of a conveyor in the form of a syringe on the fitting;

12B is a cross-sectional view of one connected to the connector

Conveyor (here in the form of a syringe);

Fig. 13 is a view of a terminal assembly in the form of a Y-connector; and

14 is an exploded view of the arrangement of FIG. 13th

Fig. 1 shows a container 1 in the form of a flexible bag having a bag body 10 for receiving a medical liquid, for example a medicament, a saline or a nutrient solution or the like. In the container 1, the medical fluid can be stored, which can be filled via connectors 1 1, 12 liquid in the container 1 or removed from the container 1. The connecting pieces 1 1, 12 provide access to the container. 1 In the illustrated embodiment, a first connector 1 1 is hereby designed to allow together with a Ansetzteil 2 connecting a conveyor 5 in the form of a syringe (see FIGS. 12A and 12B) to connect via the connector 1 1 a liquid component in the container 1 in to promote. The second connector 12, however, together with a Ansetzteil 3 provides access through which, for example, an infusion set to the container 1 can be connected to supply a liquid from the container 1 out of a patient.

Fig. 2 shows an exploded view of the terminal assemblies, which are formed by the connecting pieces 1 1, 12, the attachment parts 2, 3 and between the connecting pieces 1 1, 12 and the Ansetzteilen 2, 3 sealing elements 4, 6. The connecting pieces 1 1, 12 are to place the container 1 between films and are welded to the films, so that the connecting pieces 1 1, 12 are materially connected to the films. The Ansetzteile 2, 3 are to complete the container 1 to the fittings 1 1, 12 set so that the sealing elements 4, 6 between the Ansetzteilen 2, 3 and the fittings 1 1, 12 come to rest and in this way a transition between the Ansetzteilen 2, 3 and the fittings 1 1, 12 is sealed liquid-tight.

Each Ansetzteil 2, 3 has a Abbrechstück 20, 30, which can be canceled to provide access to the container 1. Thus, the Abbrechstück 20 can be canceled by the Ansetzteil 2 to connect a conveyor 5 in the form of a syringe to the Ansetzteil 2 and to promote liquid in the container 1 into it. The break-off piece 30 can be broken off from the attachment part 3, in order, e.g. pierce an infusion set with a piercing spike through the sealing element 6 and to take over liquid from the container 1, for example, to supply the liquid to a patient.

Each Ansetzteil 2, 3 also has a connecting portion 21, 31, which can be brought into engagement with the associated connector 1 1, 12, in this way the respective Ansetzstück 2, 3 form-fitting manner with the associated connector 2, 3 to connect.

In the following, the connector provided via the first connection piece 1 1 and the attachment part 2 to be attached thereto will be explained in detail. An embodiment of a connector 1 1 and a Ansetzteil 2 comprehensive connector show Fig. 3 to 1 1st The connector 1 1 is here, as described above, to be connected with films of the container 1 and is thus absorbed in a material-locking manner between the films. At the connection piece 1 1, the Ansetzteil 2 can be recognized, so that in the attached position, the Ansetzteil 2 is held positively on the connecting piece 1 1.

The attachment piece 2 has a first portion, consisting of a connecting portion 21 and an adjoining threaded portion 22, and a Abbrechstück 20. The Ansetzstück 2 is integrally molded as a plastic molding and is in an initial state with the associated with the threaded portion 22 Abbrechstück 20 before. The connector 1 1 has a flow opening 1 1 1, which is closed at attached to the connector 1 1 Ansetzteil 2 by the Ansetzteil 2 to the outside, so that no liquid from the container 1 out or into the container 1 can get into it. When attached Ansetzteil 2 engages here, as can be seen from the sectional view of FIG. 5, the connector 1 1 with a head 1 10 in an opening 210 of the connecting portion 21 and is about a circumferential positive locking element in the form of an annular projection 1 15 axially and via positive locking elements 1 16, 1 17 in the form of axially extending webs and grooves rotatably connected to the Ansetzteil 2. Within the opening 210 of the connecting portion 21 of the Ansetzteils 2 here are complementary positive locking elements, for example in the form of an annular recess for engagement with the rotating form-fitting element 1 15 and in the form of axially extending webs and / or grooves for engagement with the webs 1 16 and grooves 17 , educated.

When attached to the connector 1 1 Ansetzteil 2, the sealing element 4 comes to rest between the Ansetzteil 2 and the connector 1 1 and is clamped between the Ansetzteil 2 and the connector 1 1 held. 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, formed 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 with a convex or planar side 400 on the threaded portion 22 also in the direction of Abragstücks 20 protrudes. However, the side 400 may also be substantially flush with the top of the threaded portion 22.

The sealing head 40 is adjoined by a cylindrical section 41, which merges into a shoulder 410 which, when the sealing element 4 is inserted into the opening 210, bears against a circumferential, conical contact surface 212 at the inner transition between the connecting section 21 and the threaded section 22 of the attachment part 2. The cylindrical portion 41 here has a larger diameter than the sealing head 40. At the shoulder 410, which projects radially beyond the portion 41 to the outside and rotates about the sealing element 4, includes a cylindrical body 42, with play in the opening 210th of the connecting portion 21 rests. The cylindrical body 42 here has a smaller diameter than the shoulder 410. By virtue of the fact that this body 42 rests in 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 conveyor 5 is attached, to create a flow through the sealing element 4 between the conveyor 5 and the container 1.

At a side facing away from the sealing head 40 end of the body 42 carries a circumferential flange 420. The flange 420 is located with its bottom 422 on a support surface 1 14 of the connector 1 1 on. Its top 421 can be completely exposed. The top 421 is not covered in this case. It is not in abutment or in engagement with a corresponding component. For example, the top 421 is not covered with a clamping surface of the fitting 2. The upper side 421 of the flange 420 can also be exposed only in sections. The flange 420 may come in this configuration when attached to the connector 1 1 Ansetzteil 2 sections between an annular projection 21 1 of the connecting portion 21 and a support surface 1 14 on the head 1 10 of the connector 1 1 come to rest and thus partially clamping between the annular projection 21 first and the support surface 1 14 are held. There is a radially outer portion of the flange 420 held clamped.

Above the flange 420 or at one at a transition to the flange 420, the cylindrical body 42 has a recess 423 in its outside. As a result, the deformation of the sealing element 4 when attaching a conveyor 5 can be supported. The recess 423 is provided by a step in the outside. In cross-section, the recess 423 has a substantially straight Ground. For example, the recess 423 has a cuboid cross-section. The bottom and the radial opening of the recess 423 can hereby (seen in the insertion direction E) have substantially the same dimensions. To the flange 420 includes a foot portion 43, which engages in a recess 1 13 on the head 1 10 of the connector 1 1.

In the attached position, the Ansetzteil 2 is the front side on an outer flange 1 12 of the connector 1 1.

Characterized in that the sealing element 4 is supported with the shoulder 410 on the one hand on Ansetzteil 2 and its flange 420 and the foot portion 1 13 on the other hand on the connector 1 1, a defined, secured position of the sealing element 4 is ensured within the opening 210 of the Ansetzteils 2. By a cylindrical inner opening 44 which extends through the body 42 and the cylindrical portion 41 of the sealing element 4 from the foot portion 43 to the sealing head 40 and is in fluid communication with a tapered flow portion 1 18 of the connector 1 1 1, can at At the Ansetzteil 2 attached conveyor 5, a high flow between the conveyor 5 and the container 1 can be achieved. Preferably, the inner opening 44 has a diameter in a range of 1 mm to 5 mm, preferably 2 mm to 4 mm.

In an initial state, shown in Fig. 5, the Ansetzteil 2 is attached together with the sealing element 4 to the connecting piece 1 1, so that the connecting piece 1 1 is closed to the outside. The sealing element 4 is not accessible from the outside in this initial state, because the upper side 400 of the sealing head 40 is covered in the opening 221 of the threaded portion 22 to the outside of the Abbrechstück 20.

The Abbrechstück 20 is connected via a predetermined breaking point 200 in the form of a notched, circumferential recess with the threaded portion 22. In order to connect a conveyor 5, for example in the form of a syringe, to the attachment part 2 and in this way to provide access to the container 1 for filling a liquid, a user can break off the break-off piece 20 from the threaded portion 22 by providing a grip element 201 of the Abbrechstücks 20 engages with his fingers and the Abbrechstück 20 of the threaded portion 22 dissolves, as shown in Fig. 9. With removed Abbrechstück 20 is the Ansetzteil 2 thus without Abbrechstück 20 before, as shown in Fig. 10. After canceling the Abbrechstücks 20, the sealing element 4 is exposed with its outwardly facing, for example, convex or planar side 400 on the sealing head 40 so that this outwardly facing side 400 can be accessed from the outside. In an embodiment in which the side 400 is convex and projects outwardly in an arcuate manner over an upper side 222 of the threaded section 22, the sealing element 4 can be wiped or dabbed on this side 400 in a favorable manner to the sealing element 4 - accordingly any existing legal requirements - to clean and disinfect. Even a flat side 400 can be wiped off or dabbed accordingly.

Then, as shown in FIGS. 12A and 12B, a conveyor 5 in the form of a syringe can be attached to the threaded portion 22 by screwing a connecting element 50 in the form of a nut or nut of the conveyor 5 via threads 500 with threads 220 on the threaded portion 22 in Intervention is brought. As a result, a connecting piece 51 of the conveyor 5 is inserted into the engagement opening 221 on the threaded portion 22, so that the connecting piece 51 presses on the sealing head 40 of the sealing element 4, this first presses down and then at the slot opening 45 (see Fig. 1 1) opens , The connecting piece 51 thus penetrates the sealing head 40 at the slot opening 45 and comes into fluid communication with the cylindrical opening 44, so that a flow between the conveyor 5 and the flow opening 1 1 1 of the connecting piece 1 1 is provided. When pushing the connection piece 51 into the engagement opening 221 and the sealing head 40 is pressed into the Ansetzteil 2 and pushed together with the other sections 41, 42 in the space radially outward of the section 42 available space aside. When completely inserted connecting piece 51, the connecting piece 51 engages positively in the engagement opening 221 and passes through the sealing head 40, wherein a favorable flow connection between the connecting piece 51 and the flow opening 1 18 at the head 1 10 of the connector 1 1 is created, not or only insignificantly is impaired by the sealing element 4. The conveyor 5 extends at the latest in fully scheduled, here, for example screwed, state with its connection piece 51 through the slot opening 45 of the sealing element 4, so that a flow between the conveyor 5 and the container 1 without hindrance or substantially unhindered by the sealing element 4 can. Preferably, As shown, the entire opening cross-section in the conveyor 5, through which the liquid transport takes place, released.

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

Because in the sealing head 40 of the sealing element 4 a, for example, cross-shaped or straight, slot opening 45 is provided, a needle-free access is provided, which can be accessed using a conveyor 5 without injection needle. When attaching the conveyor 5, the connecting piece 51 engages with the slot opening 45 and opens in this way the sealing element 4, so that a flow between the conveyor 5 and the container 1 is created. After removal of the conveyor 5 of the Ansetzteil 2, the sealing element 4 closes automatically and self-sealing again, so that no liquid can get out of the container 1.

FIGS. 13 and 14 show a further embodiment in which a connection assembly consisting of a connection piece 1 1, an attachment part 2 arranged thereon and a sealing element 4 is used.

In this case, the connection module 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 flow connection with the connection piece 1 1 at a connection point 72, so that via the connection piece 1 1 a medical fluid can be introduced into a line system connected to the line connections 70, 71 or removed from the line system ,

At the connecting piece 1 1 a Ansetzteil 2 is arranged in this embodiment. Between the Ansetzteil 2 and the connecting piece 1 1, a sealing element 4 is clamped. As in the embodiment according to FIGS. 1 to 12, a break-off piece 20 is connected to the threaded portion 22 of the attachment part 2, which can be broken off to connect a conveyor 5 (see FIG. 12) to the threaded portion 22 and the conveyor 5 above the Connection piece 1 1 to connect. Because the sealing element 4 with a convex side 400 on the top 222 of the threaded portion 22 can protrude outwardly and thus easily accessible from the outside, the sealing element 4 can be wiped at its side 400 before connecting the conveyor 5 in a comfortable manner to disinfect the sealing element 4 on its outwardly facing side 400. Even a flat side 400 can be wiped off or dabbed accordingly.

Both the connector 1 1 and the Ansetzteil 2 are identical in their design and function as described above for the embodiment of FIGS. 1 to 12B, so that reference should be made to the preceding embodiments.

The idea underlying the invention is not limited to the embodiments described above, but can also be realized in a completely different kind of way.

LIST OF REFERENCE NUMBERS

1 bag

10 bag bodies

1 1, 12 connection piece

1 10, 120 head

1 1 1 flow opening

1 12 flange

1 13 recess

1 14 bearing surface

1 15 positive locking element (annular projection)

1 16 footbridge

1 17 groove

1 18 flow opening

2 attachment part

20 withdrawal piece

200 predetermined breaking point

201 handle element

21 connecting section

210 opening

21 1 ring projection

212 contact surface

22 threaded section

220 threads

221 engagement opening

222 top

3 attachment part

30 withdrawal piece

31 connection section

4 sealing element

40 sealing head

400 convex or flat side

41 section

410 shoulder

42 bodies

420 flange

421 Top of the flange Bottom of the flange

Depression or step in the outside of the sealing element or body 42

foot section

opening

slot opening

Conveyor (syringe)

connecting element

0 threads

Connecting piece (syringe cone)

syringe body

stamp

sealing element

connector

, 71 line connection

junction

insertion

Claims

claims

1 . Terminal assembly for conducting a medical fluid, with

- A connection piece (1 1) through which a medical fluid can be conveyed, an attachable to the connector (1 1) Ansetzteil (2), with a conveying device (5) for conveying a medical fluid through the connecting piece (1 1) connectable is and

a sealing element (4) for sealing a transition between the connecting piece (1 1, 12) and the Ansetzteil (2) such that at the

Connection piece (1 1) attached Ansetzteil (2) the sealing element (4) between the Ansetzteil (2) and the connecting piece (1 1) is held, wherein the sealing element (4) has a sealing head (40) which in at the connection piece (1 1) attached Ansetzteil (2) closes an opening (210) of the Ansetzteils (2) against a liquid passage, and one of the sealing head (40) adjoining body (42) at a radial distance to the Ansetzteil (2) in the opening (210 ) is arranged, and an interior of the sealing element (4) is free of a body with a tip, which is to assist the opening of the sealing element (4), characterized in that the sealing element (4)

- At the transition between the sealing head (40) and the body (42) radially to the insertion direction (E) via the sealing head (40) projecting shoulder (410) along the insertion direction (E) in abutment with an associated abutment surface (212) within the opening (210) of the Ansetzteils (2) can be brought,

- A along the insertion direction (E) to the shoulder (410) spaced, relative to the body (42) of the sealing element (4) radially outwardly projecting flange (420) attached to the fitting (1 1)

Ansetzteil (2) between the Ansetzteil (2) and the connecting piece (1 1) is held such that the flange (420) rests with its underside (422) on a support surface (1 14) of the connecting piece (1 1) 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) connects to the body (42) and at the Connecting piece (1 1) attached Ansetzteil (2) engages in an associated recess (1 13) in the connecting piece (1 1),

having.

Terminal assembly according to claim 1, characterized in that the sealing element (4) on one side (400), which faces away from the connecting piece (1 1) attached to the connecting piece (1 1) Ansetzteil (2), is convex or flat ,

Terminal assembly according to claim 2, characterized in that the sealing head (40) conveys the convex or planar side (400).

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

Terminal assembly according to one of the preceding claims, characterized in that the flange (420) with attached to the connecting piece (1 1) Ansetzteil (2) in sections clamping between a support surface (1 14) of the connecting piece (1 1) and a radially inward in the opening (210) protruding projection (21 1), for example, annular projection (21 1), the Ansetzteils (21) is held.

Terminal assembly according to one of the preceding claims, characterized in that, viewed axially along the insertion direction (E), the sealing head (40) a, preferably cylindrical, section (41) connects, which merges into the shoulder (410), the radial projects outwardly beyond the section (41).

Terminal assembly according to one of the preceding claims, characterized in that, viewed axially along the direction of insertion (E), to the Shoulder (410) of the, preferably cylindrically shaped, body (42) connects, wherein the shoulder (410) projects radially beyond the body (42) to the outside.

Terminal assembly according to one of the preceding claims, characterized in that the body (42) at a transition to the flange (420) has a, preferably provided by a step, recess (423) in its outer side.

Terminal assembly according to one of the preceding claims, characterized in that the sealing element (4) has a slot opening (45) which closes when attached to the connecting piece (1 1) Ansetzteil (2) against a liquid passage and by connecting the conveyor (5) To open the attachment part (2) is such that a medical fluid through the slot opening (45) can be conveyed through.

10. Terminal assembly according to one of the preceding claims, characterized in that the attachment part (2)

- A first portion (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 (5) to the attachment part (2),

having.

1 1. Terminal assembly according to claim 10, characterized in that the first portion (21, 22) by an attachable to the connecting piece (1 1) connecting portion (21) and to the connecting portion (21) adjoining threaded portion (22), preferably at least one half Thread (220), for making a threaded connection with the conveyor (5) is formed, wherein the Abbrechstück (20) in the initial state with the threaded portion (22) is connected and for connecting the conveyor (5) with the Ansetzteil (2) the threaded portion (22) is removable.

12. Terminal assembly according to claim 1 1, characterized in that the threaded portion (22) and the Abbrechstück (20) are integrally formed, wherein between the threaded portion (22) and the Abbrechstück (20) a predetermined breaking point (200) for canceling the Abbrechstücks (20) of the threaded portion (22) is formed.

13. Terminal assembly according to claim 1 1 or 12, characterized in that the sealing element (4) in an engagement opening (221) of the threaded portion (22) rests.

14. Terminal assembly according to one of claims 1 1 to 13, characterized in that the sealing element (4) projecting beyond the threaded portion (22) Abbrechstück beyond an upper side (222) of the threaded portion (22) outwardly or substantially flush with an upper side (222) of the threaded portion (22) closes.

15. Terminal assembly according to one of the preceding claims, characterized in that the connecting piece (1 1) attached to the connecting piece (1 1) Ansetzteil (2) with a head (1 10) in the opening (210) of the Ansetzteils (2) engages and / or that on the head (1 10) around the insertion direction (E) encircling positive-locking element (1 15) is arranged, when attached to the connecting piece (1 1) Ansetzteil (2) for axially fixing the Ansetzteils (2) to the connection piece (1 1) in positive engagement with the Ansetzteil (2).

16. Terminal assembly according to claim 15, characterized in that on the head (1 10) at least one parallel to the insertion direction (E) extended web (1 16) and / or at least one parallel to the insertion direction (E) extending groove (1 17) for Rotationally fixed fixing of the Ansetzteils (2) to the connector (1 1) is arranged.

17. Sealing element (4) for a connection assembly according to one of the preceding claims 1 to 16, comprising a sealing head (40) and a sealing head (40) adjoining the body (42), wherein the sealing element (4)

- At a transition between the sealing head (40) and the body (42) radially to an insertion direction (E) via the sealing head (40) projecting shoulder (410) along the insertion direction (E) in abutment with an associated bearing surface ( 212) within an opening (210) of a connector (2) can be brought,

- A along the insertion direction (E) to the shoulder (410) spaced, relative to the body (42) of the sealing element (4) radially outwardly projecting flange (420), wherein the flange (420) with its bottom (422) on a Resting support surface (1 14) of the connecting piece (1 1) and its upper side (421) can be exposed at least in sections, and

- A foot portion (43) which, viewed axially along the insertion direction (E), below the flange (420) connects to the body (42) and in attached to the connecting piece (1 1) Ansetzteil (2) in an associated recess ( 1 13) in the connecting piece (1 1) can engage has.

18. Arrangement with a connection assembly according to one of the preceding claims 1 to 16 or with a sealing element (4) according to claim 17 and a conveyor (5) having a connecting piece (51) for attachment to the Ansetzteil (2), wherein at the attachment part (2) of the attached delivery device (5) of the connecting piece (51) penetrates the slot opening (45) of the sealing element (4).