HK1247551B - Connection assembly for guiding a medical liquid - Google Patents

Description

The invention relates to a connection component group for directing a medical fluid as defined in the broadest sense of Claim 1.

Such a connector module can, for example, be used on a container for medical fluids, such as a flexible bag, an ampoule, or any other bottle container, to direct a medical fluid into the container or to remove it from the container. Such a connector module can also be briefly referred to as a connector.

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

In a connector known from WO 2010/034470 A1, a hollow body with a tip is arranged on one side of a membrane that is adapted to have a syringe attached to it. The hollow body supports the opening of the membrane. When the syringe is attached to the connector, the membrane is pressed against the tip of the hollow body by the syringe, allowing the syringe to come into contact with the hollow body and thus enabling a flow through the membrane and the hollow body.

A valve unit with a hollow body that supports the opening of the membrane is also depicted in WO 93/11828 A1. The document shows a needle-free valve unit with a tubular body that defines an internal cavity. The valve unit further includes a hollow spike with a closed tip, arranged within the cavity. Additionally, the valve unit 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 side wall, and a lower sealing lip. The lower sealing lip is held in place clamping between an annular flange and the underside of a ring.

Such connectors are, for example, used to create what is known as a needle-free access to a container holding a medical fluid, such as a bag or bottle, in order to add fluid to the container or remove fluid from it through this access. Such needle-free access allows access to the container using a pumping device that does not have an injection needle. Instead, for example, the nozzle of a pumping device, such as a syringe, is attached to a slit opening in a sealing element, thereby opening the slit and enabling a flow between the pumping device and the container in this way.

By using needle-free access methods, the risk of injury that would otherwise exist with the use of injection needles can be significantly reduced.

Even though the sealing element is already provided in a sterile condition, legal requirements may necessitate wiping or swabbing the outer surface of the sealing element before connecting a pumping device to the fitting. This ensures access, for example, to a container, under sterile conditions. Such swabbable or wipeable connectors are known, for example, from EP 1 470 352 B1 and EP 1 217 284 B1.

The US 2010/0298782 A1 describes an intravascular valve component which includes a valve housing and a flexible, pressure-actuated flow control valve. The housing consists of a proximal and a distal housing part that are connected to each other. The valve includes a slotted central valve plate and a circular flange surrounding the valve plate. The flange has a radially extending flange wall and a protrusion extending axially from the flange wall. The protrusion engages with a part of the valve housing to restrict the radial movement of the valve relative to the housing.

WO 98/26835 discloses a connector module with a deformable sealing element whose inner space has a point or tip.

The task of the present invention is to provide a connector assembly for directing a medical fluid that allows for a reliable hold but also a certain mobility of the sealing element. In particular, the flow should not be significantly impaired. Another task is to provide a connector assembly in which it is easily possible to wipe or swab a sealing element for disinfection purposes.

This task is solved by an object with the features of claim 1.

It is a connector assembly for directing a medical fluid. It includes a connector piece through which a medical fluid can be conveyed, and a mountable fitting that can be attached to the connector piece and is connectable with a conveying device for conveying a medical fluid through the connector piece. Preferably, the fitting has an opening into which the connector piece fits when the fitting is mounted on the connector piece. The connector assembly also includes a sealing element for sealing a transition between the connector piece and the fitting. Preferably, the sealing element is insertable into an insertion direction of the opening of the fitting such that when the fitting is mounted on the connector piece, the sealing element is held between the fitting and the connector piece. The inner space of the sealing element is free from a pointed body that is supposed to support opening the sealing element.

The sealing element features a seal head that, when attached to the connecting piece with the fitting part, closes off the opening of the fitting part against fluid ingress, and a body that follows the seal head and is positionable or positioned radially relative to the fitting part within the opening.

The sealing element features a shoulder that extends radially outward from the seating direction over the sealing head, which can be brought into engagement with an associated seating surface along the seating direction within the opening of the seating part. Additionally, it has a flange that extends radially outward relative to the body of the sealing element and is spaced apart from the shoulder along the seating direction. When the seating part is attached to the connecting piece, the flange is preferably held, in a clamping manner, between the seating part and the connecting piece.

The sealing element is held between the fitting part and the connecting piece when the fitting part is attached to the connecting piece such that the flange rests with its underside on a support surface of the connecting piece and its top side is at least partially exposed. The sealing element includes a foot section that, viewed axially along the insertion direction (E), connects below the flange to the body and, when the fitting part is attached to the connecting piece, extends into an associated recess in the connecting piece.

The sealing element is held in a clamping manner between the fitting part and the connector piece when the fitting part is attached to the connector piece, ensuring a fluid-tight seal between the fitting part and the connector piece. The sealing element has a shoulder that runs around the insertion direction, protruding radially outward over the sealing head, and when the fitting part is attached to the connector piece, it rests against an associated seating surface of the fitting part. Through this shoulder, the sealing element is particularly supported axially along the insertion direction relative to the fitting part, thus being fixed axially relative to the fitting part via the shoulder.

Preferably, the diameter of the sealing element at the shoulder is in a range of 4 mm to 10 mm, preferably from 6 mm to 8 mm. By supporting the sealing element on one side by the mounting part and on the other side by its flange and foot section through the connecting piece, a defined and secure position of the sealing element within the opening of the mounting part can be ensured.

The cylindrical-shaped body of the sealing element is attached to the shoulder. The sealing element preferably has a rotational symmetric shape, although different sections of the sealing element can have different diameters. The body attached to the shoulder is arranged with radial play within the opening of the connection part, so that there is space around the body inside the opening of the connection part, into which the sealing element can deform when a conveying device is attached to the connection part. Since there is thus radial space towards the wall of the connection part within the opening, into which the sealing element can be pressed sideways when a conveying device, such as a syringe, with a connecting pin is attached to the sealing element, a slit opening at the sealing head of the sealing element can be reliably opened and, in the open state, unobstructed flow between the conveying device and the connecting piece can be enabled through the sealing element.

The body is connected to a radially outward protruding flange. This flange extends outward from above the body. When the fitting part is attached to the connection piece, the flange is held or secured in a clamping manner between the fitting part and the connection piece in such a way that the flange itself is not clamped. This indirect clamping hold of the flange is achieved by supporting the sealing element on one side with the shoulder of the fitting part and on the other side through its flange and/or foot section against the connection piece. In this position, the underside of the flange rests simply on a support surface of the connection piece, while its top side lies preferably sectionally or entirely free. Thus, the sealing element is secured between the fitting part and the connection piece via the flange.where the flange is preferably located at one of the body ends that is away from the shoulder, thus supporting the sealing element against the attachment part and the connector piece with the shoulder on one side of the body and with the flange on the other side of the body. Preferably, the diameter of the sealing element at the flange is larger than at the shoulder. Preferably, the diameter of the flange is in a range of 5 mm to 11 mm, preferably from 7 mm to 9 mm. The sealing element thus has a certain degree of mobility because the flange itself is not held tightly. This allows the syringe nozzle to be inserted first, with the sealing head being pushed downwards into the housing by the syringe nozzle.The side wall of the sealing element can expand radially in this process. Then, the sealing element can be opened by inserting the plunger rod of the syringe into a slot opening in the seal head. In particular, the radial expansion movement of the side wall can be supported by the movable arrangement of the flange.

In an execution form, a radial outer section of the flange can be held clamping between a support surface of the coupling piece and a radially inwardly protruding projection of the fitting part, for example, initially. Preferably, the projection is a ring projection. The ring projection can extend entirely or only partially around the circumference of the sealing element. Thus, the sealing element can be fixed, for example, entirely, within the opening via the ring projection, where the radially inwardly protruding ring projection of the body maintains a radial distance from the outer wall surrounding the opening of the fitting part. Consequently, the ring projection can on the one hand achieve a partial clamping fixation of the sealing element between the fitting part and the coupling piece. Additionally, the ring projection can support the (centered) position of the sealing element within the opening by maintaining a radial distance from the wall surrounding the sealing element of the fitting part. In another embodiment, the connection between the coupling piece and the fitting part can also be provided via the ring projection.

Preferably, the sealing element on the outer side, which is away from the attachment piece when the attaching part is positioned against the attachment piece, is convexly shaped. However, it is also conceivable and possible that the sealing element on the outer side is essentially flat or concavely curved inward.

The outer side can, especially in a state where a pumping device is connectable to the coupling part, protrude outward beyond the coupling part or be flush with a surface of the coupling part, so that before connecting the pumping device, the outer side of the sealing element can be accessed from the outside without further action and wiped or swabbed for sterilization purposes. The coupling part may have a break-off piece that, in its initial state, is integrally connected to another section of the coupling part, which is connected to the connector piece, and can be removed from this section, especially broken off, to connect a pumping device to the coupling part. When the break-off piece is removed from the coupling part, the sealing element with its outer side can protrude outward, allowing the outer side to be wiped or swabbed from the outside. The connector assembly, and in particular also the outer side of the sealing element, can already be sterilized in its initial state, i.e., before the break-off piece has been broken off.

The outer side is formed by the head of the sealing element. For example, if a stop piece is removed from the fitting part, essentially only the outer side of the sealing element is exposed to the outside, which, for instance, protrudes outward in a convexly arched manner and can be easily and reliably wiped or dabbed. Preferably, the upper or outer side of the sealing head has a diameter in the range of 3 mm to 7 mm, preferably from 4 mm to 6 mm.

The shoulder is preferably located at an end of the seal head that is turned away from the outside. In the inventive connector, there is no hollow body with a tip designed to assist in opening the membrane. There is no body or hollow body with a tip arranged inside the seal element to assist in opening the seal head.

According to another embodiment, a cylindrical section preferably connects to the seal head axially along the insertion direction (E), which extends into the shoulder and protrudes radially outward beyond the section. This section preferably has a larger diameter than the seal head. Additionally, the shoulder of the cylindrical body can connect axially along the insertion direction (E), with the shoulder protruding radially outward beyond the body. Furthermore, the body can have a recess on its outer side at a transition to the flange, preferably provided as or by a step. In particular, there is only one single step in the body. This supports the radial adjustment movement of the seal element when attaching the syringe, for example, through a kind of expansion. In cross-section, the recess can have essentially a straight bottom. For example, the recess can have a rectangular cross-section. In this case, the bottom and the radial opening of the recess can essentially have the same dimensions.

A foot section can be attached to the flange, extending along the insertion direction in front of the flange. When the insertion part is positioned against the connection piece, this foot section will fit into a corresponding recess in the connection piece. This thus creates an advantageous connection between the sealing element and the connection piece when the sealing element is positioned at a defined location within the opening of the insertion part. The sealing element can therefore be supported by the shoulder on one side of its body and by the flange and/or the foot section on the other side of its body against the insertion part and the connection piece. Preferably, the sealing element has a total height in the range of 6 mm to 15 mm, preferably from 9 mm to 12 mm.

The orifice element preferably has a slot opening at its head, which is closed against fluid ingress when the fitting part is attached to the insertion part and is to be opened by connecting the pumping device to the insertion part in such a way that a medical fluid can be pumped through the slot opening. Thus, such a slot opening creates a needle-free access, allowing access to, for example, a container connected to the fitting part using a pumping device that does not have an injection needle.

The extraction device can, for example, be mounted with a connecting rod to the sealing element, where the connecting rod preferably first shifts the upper side of the sealing element downward by pressure and then enters the slot opening, thus opening the sealing element to create a flow path. The extraction device extends at least as far as when it is fully installed, for example, securely screwed in, preferably with the connecting rod, through the slot opening of the sealing element, so that a flow between the extraction device and the container can occur unobstructed through the sealing element. In one embodiment, at least 80%, preferably at least 90%, of the cross-sectional area for fluid transport in the extraction device is left open and is therefore not covered by the seal. Preferably, the entire cross-sectional area of the opening in the extraction device through which fluid transport occurs is left open.

The fitting part is preferably a one-piece plastic component, preferably a plastic injection molded part, shaped. The fitting part has a first section and a break-off piece here. Preferably, the opening is formed in the first section, into which the connecting part fits when attached to the fitting part. The break-off piece is connected to the first section in its initial state and can be removed from the first section, especially broken off, for attaching a conveying device to the fitting part. The sealing element is held on the first section and seals the opening of the first section externally when the break-off piece is broken off. The outer side of the sealing element faces outward and preferably extends outward over the first section or is flush with the first section. In an embodiment, the fitting part provides a, preferably female, Luer connector.

The first section is concretely formed by a connecting section that can be attached to the fitting piece and a threaded section following the connecting section. The threaded section has at least one full thread pitch for establishing a threaded connection with the pump device. Preferably, the threaded connection is provided by a double-threaded design. This way, a so-called Luer-Lock connector is made available, with which a connecting element in the form of a taper lock nut of a pump device, such as a Luer-Lock syringe, can be connected to form a Luer-Lock connection. In its initial state, the disconnect piece is connected to the threaded section, thereby closing the fitting piece externally. To connect the pump device to the fitting piece, the disconnect piece can be removed from the threaded section, specifically broken off, so that the pump device can be screwed together with its connecting element with the threaded section.

The threaded section and the break-off piece are advantageously integrally and monolithically connected to each other in the initial state. Between the threaded section and the break-off piece, a predetermined fracture point can be provided, for example, in the form of a circumferential grooved recess, which allows for the defined removal of the break-off piece from the threaded section along a line specified by the predetermined fracture point.

The sealing element is preferably positioned with its sealing head within a tapping opening of the threaded section in such a way that essentially only the outer side of the sealing head is accessible from the outside. Especially when the outer side protrudes outward beyond the threaded section or aligns flush with the top surface of the threaded section, the sealing element can be advantageously cleaned or wiped externally if the tapping piece is interrupted. This allows a conveying device to be attached to the fitting part under sterile conditions and connected to the connecting piece.

The connecting piece preferably engages into the opening of the fitting part with a head when the fitting part is attached to the connecting piece. The connecting piece can advantageously be form-fit connected to the fitting part, for example, by a form-locking element that surrounds the insertion direction, such as a circumferential projection ring, on the head of the connecting piece engaging with an associated form-locking element on the side of the fitting part, thereby axially fixing the fitting part relative to the connecting piece. Additionally, one or more form-locking elements may be provided on the head to achieve a rotationally fixed positioning of the fitting part at the head. For example, one or more protrusions extending parallel to the insertion direction and/or one or more recesses extending parallel to the insertion direction may be provided on the head, into which associated complementary form-locking elements on the side of the fitting part engage when the fitting part is attached to the connecting piece, thus fixing the fitting part in a rotationally fixed manner relative to the connecting piece.

The coupling assembly and/or the sealing element can be part of a container for medical fluids. In this case, the coupling piece is connected to the container and provides access to it. By attaching the fitting part to the coupling piece and/or using an integral connector on the coupling piece that includes the sealing element, a pumping device can be connected to the coupling piece to pump a medical fluid into or out of the container.

The connection module can alternatively be part of a connector to which medical lines can be connected. For example, the connection module can be part of what is called a Y-connector, to which two lines and, via the mounting part, a pumping device can also be connected.

Furthermore, the invention encompasses a sealing element for an embodiment of the previously described connector assembly and/or the previously described connector. The sealing element includes a sealing head and a body attached to the sealing head, wherein the sealing element has a shoulder that protrudes radially outward from the sealing head in the direction of insertion, located at the transition between the sealing head and the body. This shoulder can be brought into engagement with an associated seating surface within an opening of a connector along the direction of insertion. Additionally, there is a flange that extends radially outward from the body of the sealing element, opposite to the shoulder, and is spaced apart from it along the direction of insertion. Preferably, this flange can be held by clamping within the connector. The underside of the flange can rest on a head of a connector piece, while its top side can be at least partially exposed. Furthermore, a foot section, which connects to the body below the flange when viewed axially along the direction of insertion (E), can engage an associated recess in a head of the connector piece when the fitting part is attached to the connector piece. For possible embodiments of the sealing element, reference is made to the previous description.

The invention also encompasses an arrangement that includes an embodiment of the previously described connector component or an embodiment of the previously described sealing element and a conveying device, which has a connecting pin for attaching to the mounting part. When the conveying device is attached to the mounting part, the connecting pin penetrates the slot opening of the sealing element.

The idea underlying the invention will be further explained below using the detailed examples illustrated in the figures. They show: Fig. 1 - a view of a container in the form of a bag with attached connecting pieces, to which coupling parts are mounted; Fig. 2 - an exploded view of the connecting pieces and coupling parts with seal elements to be arranged between them; Fig. 3 - a separate view of a connecting piece with a mounted coupling part; Fig. 4 - a front view of the arrangement as shown in Fig. 3; Fig. 5 - a cross-sectional view corresponding to the plane of the drawing according to Fig. 4; Fig. 6 - a separate view of a coupling part; Fig. 7 - a separate view of a seal 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 coupling part on the connecting piece, with broken-off break-off piece; Fig. 10 - an enlarged view of the coupling part, with broken-off break-off piece; Fig. 11 - the cross-sectional view according to Fig. 5, with broken-off break-off piece; Fig. 12A - a schematic view of a conveying device in the form of a syringe on the connecting piece; Fig. 12B - a cross-sectional view of a conveying device connected to the connecting piece (here in the form of a syringe); Fig. 13 - a view of a connection group in the form of a Y-connector; and Fig. 14 - an exploded view of the arrangement according to Fig. 13.

Fig. 1 shows a container 1 in the form of a flexible bag, which has a bag body 10 for holding a medical fluid, such as a medication, a saline solution, or a nutrient solution, etc. The medical fluid can be stored in the container 1, and fluid can be filled into or drawn from the container 1 via connectors 11, 12.

The connectors 11, 12 provide access to the container 1. In the illustrated embodiment, the first connector 11 is designed to, together with a fitting part 2, allow the connection of a pumping device 5 in the form of a syringe (see Fig. 12A and 12B), enabling the introduction of a liquid component into the container 1 via the connector 11. On the other hand, the second connector 12 provides an access point, together with a fitting part 3, through which, for example, an infusion set can be connected to the container 1 to administer a liquid from the container 1 to a patient.

Figure 2 shows in an exploded view the connection component groups formed by the connecting pieces 11, 12, the mounting parts 2, 3, and sealing elements 4, 6 located between the connecting pieces 11, 12 and the mounting parts 2, 3. The connecting pieces 11, 12 are to be placed between sheets for the production of the container 1 and are welded to the sheets, thus making the connecting pieces 11, 12 material-tightly connected to the sheets. The mounting parts 2, 3 are to be mounted onto the connecting pieces 11, 12 to complete the container 1, such that the sealing elements 4, 6 come to rest between the mounting parts 2, 3 and the connecting pieces 11, 12, thereby providing a fluid-tight seal between the mounting parts 2, 3 and the connecting pieces 11, 12.

Each fitting part 2, 3 has a break-off piece 20, 30 that can be broken off to create access to the container 1. Thus, the break-off piece 20 can be removed from the fitting part 2 to connect a pumping device 5, such as a syringe, to the fitting part 2 and thereby pump fluid into the container 1. The break-off piece 30 can be removed from the fitting part 3, for example, to insert an infusion set with a piercing needle through the seal element 6 and thereby withdraw fluid from the container 1, for instance, to administer the fluid to a patient.

Each mounting part 2, 3 also has a connection section 21, 31 that can be engaged with the associated plug piece 11, 12 in order to connect the respective mounting part 2, 3 form-fit with the associated plug piece 2, 3 in this way.

The connector provided for the first connection piece 11 and the fitting part 2 to be attached to it will be explained in detail below.

An example of a connector including a plug piece 11 and a mating part 2 is shown in Fig. 3 to 11. The plug piece 11, as previously described, is to be connected with the sheets of the container 1 and is thus inserted in a material-keyed manner between the sheets. The mating part 2 can be mounted on the plug piece 11 such that, when mounted, the mating part 2 is form-keyed to the plug piece 11.

The setting piece 2 consists of a first section, comprising a connecting section 21 and an adjoining thread section 22, and a breaking piece 20. The setting piece 2 is formed as a one-piece plastic component and is in its initial state with the breaking piece 20 connected to the thread section 22.

The attachment piece 11 has a flow opening 111 that is closed to the outside by the fitting part 2 when the fitting part 2 is attached to the attachment piece 11, thus preventing any fluid from leaving or entering the container 1. As can be seen from the cross-sectional view according to Fig. 5, when the fitting part 2 is attached, the attachment piece 11 enters an opening 210 of the connection section 21 with a head 110 and is axially connected to the fitting part 2 via a circumferential locking element in the form of a ring flange 115 and rotationally fixed via locking elements 116, 117 in the form of axially extending ribs and grooves. Within the opening 210 of the connection section 21 of the fitting part 2, complementary locking elements are formed, for example, in the form of a ring-shaped recess for engagement with the circumferential locking element 115 and in the form of axially extending ribs and/or grooves for engagement with the ribs 116 and grooves 117.

When the fitting part 2 is attached to the connection piece 11, the sealing element 4 is positioned between the fitting part 2 and the connection piece 11 and is held clamping between them. The sealing element 4 can be inserted in an insertion direction E into the opening 210 inside the fitting part 2 (see Fig. 6). As shown in Fig. 7, the sealing element 4 is formed as a rotationally symmetric body and has a sealing head 40 that comes to rest in the engagement opening 221 of the threaded section 22 and extends beyond the threaded section 22 in the direction of the break-off piece 20 with a convexly arched or flat side 400. However, the side 400 can also essentially align with the upper side of the threaded section 22.

A cylindrical section 41 is attached to the seal head 40, which transitions into a shoulder 410. When the seal element 4 is inserted into the opening 210, this shoulder rests against a circumferential, conical seating surface 212 at the inner transition between the connecting section 21 and the threaded section 22 of the mounting part 2. The cylindrical section 41 has a larger diameter here than the seal head 40.

A cylindrical body 42, which extends outward radially from the section 410 and surrounds the sealing element 4, is attached to the shoulder 410. This cylindrical body 42 fits into the opening 210 of the connection section 21 with a clearance fit. The cylindrical body 42 has a smaller diameter than the shoulder 410 here. By fitting this body 42 into the opening 210 of the connection section 21 with a radial distance from its circumferential wall, the sealing element 4 can be favorably deformed when a conveying device 5 is installed, thereby creating a flow through the sealing element 4 between the conveying device 5 and the container 1.

At one end, opposite the Dichtkopf 40, the body 42 has a circumferential flange 420. The underside 422 of the flange 420 rests on a seating surface 114 of the connection piece 11. Its top side 421 can be fully exposed. In this case, the top side 421 is not covered and does not come into contact or interfere with a corresponding component. For example, the top side 421 is not covered by a clamping surface of the connection piece 2. However, the top side 421 of the flange 420 can also be partially exposed. In this configuration, when the mounting part 2 is attached to the connection piece 11, the flange 420 can partially rest between a ring protrusion 211 of the connecting section 21 and a seating surface 114 at the head 110 of the connection piece 11, and thus be partially held clamping between the ring protrusion 211 and the seating surface 114. A radially outer section of the flange 420 is held clamping.

Below the flange 420 or at a transition to the flange 420, the cylindrical body 42 has a recess 423 on its outer side. This allows the deformation of the sealing element 4 when installing a pumping device 5 to be supported. The recess 423 is provided by a step on the outer side. In cross-section, the recess 423 has essentially a flat bottom. For example, the recess 423 can have a rectangular cross-section. The bottom and the radial opening of the recess 423 can here (viewed in the insertion direction E) essentially have the same dimensions.

A foot section 43 is attached to the flange 420, which extends into an exception 113 at the head 110 of the connector piece 11.

In the seated position, the seating part 2 is face-to-face with an outer flange 112 of the connection piece 11.

By having the sealing element 4 supported on one side by the shoulder 410 of the setting part 2 and on the other side by its flange 420 and foot section 113 of the connecting piece 11, a defined and secure position of the sealing element 4 within the opening 210 of the setting part 2 is ensured. Through a cylindrical inner opening 44 that extends from the body 42 and the cylindrical section 41 of the sealing element 4 starting from the foot section 43 to the sealing head 40 and is in flow connection with the reduced flow section 118 of the connecting piece 11, a high flow rate can be achieved between the installed pumping device 5 and the container 1 when the pumping device 5 is attached to the setting part 2. Preferably, the inner opening 44 has a diameter in the range of 1 mm to 5 mm, preferably from 2 mm to 4 mm.

In the initial state, as shown in Fig. 5, the seating part 2 is together with the sealing element 4 attached to the connection piece 11, such that the connection piece 11 is closed outwardly. The sealing element 4 is not accessible from the outside in this initial state because the top side 400 of the sealing head 40 is covered by the break-off piece 20 in the opening 221 of the threaded section 22 from the outside.

The break-off piece 20 is connected to the intended break point 200 in the form of a grooved, circumferential recess with the thread section 22. To connect a pumping device 5, for example in the form of a syringe, to the fitting part 2 and thus create access to the container 1 for filling a liquid, a user can remove the break-off piece 20 from the thread section 22 by gripping the grip element 201 of the break-off piece 20 with their fingers and unscrewing the break-off piece 20 from the thread section 22, as shown in Fig. 9. With the removed break-off piece 20, the fitting part 2 is thus present without the break-off piece 20, as shown in Fig. 10.

After the removal of the stop piece 20, the sealing element 4 with its outward-facing side 400, which is for example convex or flat, at the seal head 40 is exposed, allowing access to this outward-facing side 400 from the outside. In a variant where the side 400 is convexly shaped and protrudes outward in a curved manner above the upper side 222 of the threaded section 22, the sealing element 4 can be conveniently wiped or swabbed at this side 400 to clean and disinfect the sealing element 4 according to any existing legal requirements. A flat side 400 can also be wiped or swabbed accordingly.

Then, as shown in Fig. 12A and 12B, a pumping device 5 in the form of a syringe can be attached to the threaded section 22 by screwing a connecting element 50, which is in the form of a nut or lock nut of the pumping device 5, into engagement with threads 500 with threads 220 on the threaded section 22. This introduces a connecting rod 51 of the pumping device 5 into the engagement opening 221 on the threaded section 22, so that the connecting rod 51 presses against the sealing head 40 of the seal element 4, first pressing it downwards and then opening it at the slot opening 45 (see Fig. 11). The connecting rod 51 thus penetrates the sealing head 40 at the slot opening 45 and reaches into fluid communication with the cylindrical opening 44, thereby providing a flow between the pumping device 5 and the flow opening 111 of the connector piece 11.

When the connection pin 51 is pressed into the actuation opening 221, the sealing head 40 is also pushed into the mounting part 2 and, together with the remaining sections 41, 42, is displaced to the radially outer side of section 42, where space is available. When the connection pin 51 is fully inserted, it engages form-fittingly into the actuation opening 221 and passes through the sealing head 40, thereby creating a favorable flow connection between the connection pin 51 and the flow opening 118 at the head 110 of the connection piece 11, which is not or only slightly impaired by the sealing element 4. The pumping device 5 extends at least in its fully inserted state, here exemplarily fixed by screws, through the slot opening 45 of the sealing element 4 with its connection pin 51, so that a flow between the pumping device 5 and the container 1 can occur unobstructed or essentially unobstructed through the sealing element 4. Preferably, as shown, the entire cross-sectional area for fluid transport within the pumping device 5 is unobstructed.

The extraction unit 5 features a plunger body 52 and a stamp 53 that can be inserted into the plunger body 52 to thereby pump a liquid from the plunger body 52 into the container 1.

Since the bushing head 40 of the bushing element 4 includes a slot opening 45, for example, cross-shaped or straight, a needle-free access is created that can be accessed using a pump device 5 without an injection needle. When the pump device 5 is attached, the connecting pin 51 with the slot opening 45 comes into contact and thus opens the bushing element 4, creating a flow between the pump device 5 and the container 1.

After the removal of extraction unit 5 from assembly part 2, the sealing element 4 automatically and self-sealingly closes again, ensuring that no fluid can escape from container 1.

Figure 13 and 14 show another example of an implementation where a connector assembly, consisting of a connector piece 11, an attached mounting part 2, and a sealing element 4, is used.

In this case, the connection plug group is part of a connector 7 in the form of a so-called Y-connector. The connector 7 has two cable connections 70, 71 to which a medical line in the form of an infusion tube or similar can be connected. The cable connections 70, 71 are connected to the connecting piece 11 at a connection point 72 in terms of flow, so that a medical fluid can be introduced into a piping system connected to the cable connections 70, 71 or withdrawn from it via the connecting piece 11.

At this implementation example, a fitting part 2 is arranged at the connection piece 11. Between the fitting part 2 and the connection piece 11, a sealing element 4 is clamped. As in the implementation example according to Fig. 1 to 12, the fitting part 2 is connected with a break-off piece 20 via its threaded section 22, which can be broken off to connect a conveying device 5 (see Fig. 12) with the threaded section 22 and thereby connect the conveying device 5 to the connection piece 11. Since the sealing element 4 can protrude outwardly from the upper side 222 of the threaded section 22 with a convex side 400 and is thus accessible from the outside, the sealing element 4 can be conveniently wiped clean at its side 400 before connecting the conveying device 5 to disinfect the outer side 400 of the sealing element 4. A flat side 400 can also be wiped or polished accordingly.

Both the connector piece 11 and the setting part 2 are designed and function identically as previously described for the exemplary embodiment according to Fig. 1 to 12B, so reference should be made to the previous descriptions.

The idea underlying the invention is not limited to the previously described embodiments but can also be realized in an entirely different manner.

Reference Symbol List

Here is the translation of the German content into English: 1Bag10Bag body11, 12Connecting piece110Head111Flow opening112Flange113Exception114Seating surface115Form closure element (ring projection)116Step117Nut118Flow opening2Attachment part20Stop piece200Intended break point201Handle element21Connection section210Opening211Ring projection212Mounting surface22Threaded section220Thread grooves221Actuation opening222Top side3Attachment part30Stop piece31Connection section4Sealing element40Sealing head400Convex or flat side41Section410Shoulder42Body420Flange421Top side of flange422Bottom side of flange423Recess or step on the outer side of sealing element or body4244Foot section44Opening45Slit opening5Feeding device (syringe)50Connecting element500Thread grooves51Connecting pins (syringe cone)52Syringe body53Stamp6Sealing element7Connector70, 71Connection for tubing72Connection pointEInsertion direction

Claims (17)

1. A connection assembly for directing a medical fluid, comprising

   - a connection piece (11) through which a medical fluid can be delivered,

   - an attachment part (2) which can be attached to the connection piece (11) and which can be connected to a delivery device (5) for delivering a medical fluid through the connection piece (11), and

   - a sealing element (4) for sealing a transition between the connection piece (11, 12) and the attachment part (2) in such manner 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), wherein the sealing element (4) has a sealing head (40) which, when the attachment part (2) is attached to the connection piece (11), closes an opening (210) of the attachment part (2) against the passage of fluid, and a cylindrical body (42) adjoining the sealing head (40) which can be arranged in the opening (210) at a radial distance from the attachment part (2), such that there is a space around the body (42) within the opening (210) of the attachment part (2), into which space the sealing element (4) can deform by means of a radial compensating movement, when a delivery device (5) is attached to the attachment part (2), and wherein an interior space of the sealing element (4) is free of a body having a point which is intended to support the opening of the sealing element (4),

   wherein, the sealing element (4) has

   - at the transition between the sealing head (40) and the body (42), a shoulder (410) which projects radially to the insertion direction (E) over the sealing head (40) 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), and which 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 manner 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 exposed at least in sections, and

   - a foot section (43) which, when viewed axially along the insertion direction (E), adjoins the body (42) below the flange (420) and, when the attachment part (2) is attached to the connection piece (11), engages in an associated recess (113) in the connection piece (11).
2. The connection assembly according to claim 1, characterised in that the sealing element (4) is convex or flat on a side (400) which faces away from the connection piece (11) when the attachment part (2) is attached to the connection piece (11).
3. The connection assembly according to claim 2, characterised in that the sealing head (40) has the convex or flat side (400).
4. The connection assembly according to one of claims 1 to 3, characterised in 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 claims, characterised in that the flange (420), when the attachment part (2) is attached to the connection piece (11), is held in sections in a clamped manner between a support surface (114) of the connection piece (11) and a projection (211), for example an annular projection (211), of the attachment part (21) projecting radially inwards into the opening (210).
6. The connection assembly according to one of the preceding claims, characterised in that, when 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).
7. The connection assembly according to one of the preceding claims, characterised in that, when viewed axially along the insertion direction (E), the cylindrical body (42) adjoins the shoulder (410), wherein the shoulder (410) projects radially outwards beyond the body (42).
8. The connection assembly according to one of the preceding claims, characterised in that the body (42) has in its outer side a depression (423), preferably provided by a step, at a transition to the flange (420).
9. The connection assembly according to one of the preceding claims, characterised in that the sealing element (4) has a slot opening (45) which is closed against the passage of fluid when the attachment part (2) is attached to the connection piece (11) and can be opened by connecting the delivery device (5) to the attachment part (2) in such manner that a medical fluid can be delivered through the slot opening (45).
10. The connection assembly according to one of the preceding claims, characterised in that the attachment part (2) has

    - a first section (21,22) in which the opening (210) is formed, and

    - a break-off piece (20) which is connected to the first section (21, 22) in an initial state and can be removed from the first section (21, 22) for connecting a delivery device (5) to the attachment part (2).
11. The connection assembly according to claim 10, characterised in that the first section (21, 22) is formed by a connecting section (21) that can be attached to the connection piece (11) and a threaded section (22) adjoining the connecting section (21), preferably with at least half a thread (220), for producing a threaded connection with the delivery device (5), wherein the break-off piece (20) is connected to the threaded section (22) in the initial state and can be removed from the threaded section (22) for connecting the delivery device (5) to the attachment part (2).
12. The connection assembly according to claim 11, characterised in that the threaded section (22) and the break-off piece (20) are formed in one piece, wherein a predetermined breaking point (200) for breaking off the break-off piece (20) from the threaded section (22) is formed between the threaded section (22) and the break-off piece (20).
13. The connection assembly according to claim 11 or 12, characterised inthat the sealing element (4) lies in an engagement opening (221) of the threaded section (22).
14. The connection assembly according to one of claims 11 to 13, characterised in that the sealing element (4) projects outwards beyond an upper side (222) of the threaded section (22) when the break-off piece is removed from the threaded section (22) or ends substantially flush with an upper side (222) of the threaded section (22).
15. The connection assembly according to one of the preceding claims, characterised in that the connection 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 connection piece (11) and/or in that a form-fitting element (115) which runs around the insertion direction (E) is arranged on the head (110) and which, when the attachment part (2) is attached to the connection piece (11), is in form-fitting engagement with the attachment part (2) for axially fixing the attachment part (2) to the connection piece (11).
16. The connection assembly according to claim 15, characterised 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 fixing the attachment part (2) to the connection piece (11) in a rotationally fixed manner.
17. An arrangement comprising a connection assembly according to one of the preceding claims 1 to 16 and a delivery device (5) which has a connection nozzle (51) for attachment to the attachment part (2), wherein, when the delivery device (5) is attached to the attachment part (2), the connection nozzle (51) penetrates the slot opening (45) of the sealing element (4).