Medical packaging designed as an infusion bag

Description

Field of invention

[0001] The invention relates to a medical packaging designed as an infusion bag, which can be filled with a medical fluid for infusion, parenteral nutrition, or enteral nutrition and which includes a connector for attaching a vial. The invention further relates to a connector for attaching a vial to an infusion bag and a method for providing a fluid connection between a vial and an infusion bag. Background of the invention

[0002] To transfer a medical substance, especially a drug, into an infusion bag, it is known to design a port of the infusion bag as a so-called connector for a vial (also called a "vial").

[0003] Vials are small bottles with a crimped or crimped cap that forms a septum, which can be pierced by a hollow needle, particularly a spike. Liquid can be added or withdrawn via the hollow needle or spike. The substances contained in the vial can include, for example, toxic drugs such as cytostatics.

[0004] A connector for attaching a vial can, for example, be attached directly to the infusion bag and encompass the spike, allowing the liquid to flow directly from the vial into the infusion bag and / or from the infusion bag into the vial for dissolving the powder. This not only simplifies the transfer of the medication but also increases safety, as it creates a closed system.

[0005] Such a connector for an infusion bag is shown, for example, in the patent application WO 2012 / 101178 A1 (Fresenius Kabi Deutschland GmbH). The connector comprises a spike, whereby an axial movement of the spike enables both the opening and closing of a fluid connection between the vial and the infusion bag. After the vial is attached, the spike is clamped in the septum and can thus be moved to open or close the fluid connection by an axial displacement of the vial.

[0006] Document US 4,735,608 describes a device for storing and reconstituted antibiotics with an intravenous fluid. A first opening of a container is sealed by a membrane liner, which can be pierced for infusion using the spike of a standard IV infusion set. A second opening of the container is surrounded by a neck section, which forms a connection to which an adapter for receiving a vial of powdered antibiotics is pivotally attached. This adapter contains an internal hollow spike, so that the vial's liner is pierced when the vial is attached to the adapter. By pivoting the adapter, the spike channel within the adapter aligns with the second opening of the container, establishing a fluid connection.

[0007] Publication WO 86 / 01712 A1 describes a device for reconstituted a medicinal product. In one embodiment, the device comprises a vial adapter and a bag adapter, which enable a permanent connection between the vial and the liquid container. The bag adapter is rotatable relative to the vial adapter in order to operate a valve for establishing the liquid connection.

[0008] Drug transfer devices are also described in publication WO 2014 / 033710 A1. In this device, a two-stage flow communication is triggered by manually rotating a vial adapter relative to a liquid container adapter to establish a liquid connection between the liquid container and the initially intact vial. The manual rotation compresses the liquid transfer device along a longitudinal axis, forcing a tip through the vial stopper to establish a liquid connection with the vial's interior. This manual rotation also initiates a flow communication step with the liquid container, thereby establishing a liquid connection between the vial and the container. Object of the invention

[0009] The invention is based on the objective of providing a connector that enables a simple fluid connection between a vial and a medical packaging designed as an infusion bag. Summary of the invention

[0010] The object of the invention is already achieved by a medical packaging designed as an infusion bag and by a connector according to one of the independent claims.

[0011] Preferred embodiments of the invention can be found in the subject matter of the dependent claims, the description and the drawings.

[0012] The invention relates generally to a medical packaging designed as an infusion bag, which includes a connector for attaching a vial. The connector comprises a spike for piercing the septum of the vial to provide an initially closed fluid connection to the internal volume of the infusion bag. By rotating the spike, the fluid connection is opened and can be closed again if necessary.

[0013] The spike can be easily rotated by turning the vial that is pushed onto the spike, in order to open or close the connector.

[0014] The invention allows the insertion of the vial into the connector and the opening of the fluid connection to be done easily and safely with a single movement.

[0015] According to one embodiment of the invention, after insertion, the vial is locked into a vial receptacle of the connector and preferably cannot be removed without damage.

[0016] The infusion bag can be filled with, or is filled with, a medical fluid. The medical fluid is a liquid used for medical purposes and is preferably administered intravenously. In a preferred embodiment, the medical fluid is therefore an infusion solution. Possible examples of such infusion solutions include sterile water; saline solutions, in particular solutions containing NaCl, KCl, CaCl and / or Mg; solutions containing hydrocarbons, in particular glucose solutions; solutions, emulsions and / or suspensions containing nutrients for parenteral nutrition, in particular containing lipids, amino acids and / or glucose; colloid solutions, in particular for blood replacement therapy (e.g. Voluven®); and / or so-called premixed systems in which an active ingredient has already been added to the medical fluid.

[0017] The invention is described in detail in independent claim 1 as follows: A medical packaging designed as an infusion bag, which includes a connector for connecting a vial, wherein the connector comprises a spike for piercing a septum of the vial to provide a fluid connection to an internal volume of the infusion bag, wherein the spike is rotatably formed in the connector to open the fluid connection from the vial to the internal volume of the infusion bag, wherein the spike comprises a piercing section having a tip and a lateral notch in the side wall of the spike, wherein the lateral notch extends from the tip into the side wall of the spike, ending within the piercing section, and wherein the spike has a thread which is guided in a thread of a housing part of the connector, in particular a lower part of the connector, characterized in that the spike comprises an axially extending channel which transitions into a laterally extending, preferably radially, channel with a lateral opening, wherein the lateral opening is arranged between the thread and the piercing section and, in a closed state of the fluid connection, borders a sealing element, wherein the spike can be axially displaced by a rotational movement of the vial such that the lateral opening is moved out of the sealing element and the fluid connection from the vial to the inner volume of the infusion bag is opened.

[0018] The fluid connection can preferably be closed again by a rotational movement in the opposite direction. Fluid can flow through the fluid connection both from the vial into the infusion bag and from the infusion bag into the vial, for example to dissolve an active ingredient in powder form and / or to first dilute a liquid active ingredient.

[0019] After a, preferably complete, fluid transfer into the infusion bag, the fluid connection can be closed to prevent any residual infusion fluid from flowing back into the vial and remaining in the vial during infusion, transport and / or further handling.

[0020] The infusion bag is preferably made of films welded together, in particular polypropylene films.

[0021] The spike, which can also be described as a hollow needle, includes an axial channel through which fluid can flow to the lateral opening.

[0022] Preferably, the lateral opening is sealed by an annular sealing element when the fluid connection is closed. This ensures a good and reliable seal. The lateral opening can be provided with a large cross-sectional area, in particular greater than 2 mm².

[0023] The valve formed by the connector is operated comfortably and safely. Furthermore, it is easy to design the spike to be rotationally secured against the septum of the vial, over which the spike is rotated, since the rotational movement is perpendicular to the insertion direction. Therefore, a rotational safety device between the spike and the septum does not hinder the insertion of the septum.

[0024] Rotation of the vial causes the spike within the connector to rotate. This rotation is relative to the connector housing and / or the medical packaging, which is preferably designed as an infusion bag. The spike can therefore also rotate the medical packaging and / or the connector relative to the vial.

[0025] According to one embodiment, the connector comprises a vial receptacle in which the vial, or rather its head, can be locked into place. In the connected state, the vial is thus not only held by the spike, but also mechanically locked to the connector by its head, which forms a collar. Preferably, the vial receptacle is designed such that the connection between the vial and the connector cannot be disconnected during normal use.

[0026] According to the invention, the spike comprises a thread, in particular an external thread, which is guided in a thread, in particular an internal thread, of a housing part of the connector, in particular a lower part.

[0027] The thread, which generates an axial displacement via a rotary movement, is located behind the side opening when viewed from the vial.

[0028] According to the invention, the spike comprises a thread and a piercing section with a tip, wherein the lateral opening is located between the piercing section and the thread.

[0029] The lower part of the connector can be directly connected to the foil of the infusion bag, e.g. by encompassing a weld-in boat which is welded into a weld seam of the infusion bag.

[0030] According to another embodiment, the connector is designed as an adapter in which a housing part of the connector can be coupled or connected to the port of an infusion bag, for example via a Luer or Luer-lock connection. In this embodiment, the connector, preferably the lower part of the connector, has a connection piece for attaching to a port instead of the welding section.

[0031] Preferably, the thread is designed with at least two threads, and more preferably with exactly two threads. This allows a relatively large axial displacement to be achieved easily during rotation, in particular more than 2 mm per half turn.

[0032] In a preferred embodiment of the invention, the thread of the spike and / or the thread of a housing part of the connector includes recesses for the passage of liquid. This allows the liquid to flow past the thread over a large free cross-section.

[0033] In particular, the thread of the housing part can be segmented. This creates recesses in the thread or thread sections. These recesses are designed to form axial channels in the thread, extending along the inside of the housing part, preferably along the channel in the lower part of the connector.

[0034] Preferably, the thread of the spike also includes at least one, and preferably several, axially extending recesses. These recesses can be designed, in particular, as flattened sections of the thread teeth. When the connector is open, the recesses of the thread on the spike overlap at least partially with the recesses of the thread in the housing part of the connector. This creates an axially extending channel in the thread, enabling an axial fluid connection from the lateral opening to the infusion bag.

[0035] The spike is preferably designed such that it is secured against rotation within the septum of the vial. This is particularly possible by a cross-section that deviates from a round shape. In particular, the spike can have a cross-section that is at least partially polygonal, especially trapezoidal, at least in the area where the septum of the vial is located when inserted.

[0036] In a preferred embodiment of the invention, the spike extends through a lower part of the connector and through a further adjacent housing part of the connector, in particular through a middle part which is connected to the lower part, wherein the lower part is sealed against the adjacent housing part via the sealing element.

[0037] The sealing element not only seals the lateral opening of the spike when the fluid connection is closed, but also simultaneously forms a seal between the internal volume of the infusion bag and the outside. For this purpose, the sealing element is located specifically between the lower housing part and the middle housing part of the connector.

[0038] The connector is preferably designed such that the spike is moved from a closed to an open position by a quarter turn or more, and / or less than a full turn, in particular by about half a turn.

[0039] According to one embodiment, the connector comprises a lower part with a thread for the spike and a middle part, wherein the sealing element is arranged at least in the middle part, and the lower part and middle part are interlocked. Thus, the middle part and the lower part are simply interlocked during assembly of the connector, with the sealing element inserted between them and held in place by clamping. The sealing element is preferably compressed during interlocking. Preferably, the lower part and the middle part are secured against rotation relative to each other, in particular by means of an interlocking toothed connection.

[0040] To ensure a secure fit of the sealing element, a sealing element with a circumferential annular section can be used, which is positively locked in a groove provided by the connector housing. The housing groove can, in particular, comprise a lower section in the bottom part and an upper section in the middle part.

[0041] The sealing element consists of at least one elastic material, in particular TPE (thermoplastic elastomer) polyisoprene, EPDM (ethylene propylene diene monomer rubber), bromobutyl or chlorobutyl.

[0042] The spike is preferably made of plastic. In particular, the spike is made of a harder material than the housing components of the connector, especially the lower part of the connector. This allows the spike to be easily inserted into the septum.

[0043] In particular, the spike material comprises a polycarbonate. This material is hard and autoclavable. The connector housing components, especially the lower part, the middle part, and / or the vial holder, preferably comprise polypropylene.

[0044] In one embodiment, the connector comprises a vial receptacle with a plurality of clamping fingers inclined inwards in the insertion direction of the vial.

[0045] According to this embodiment, a secure locking of the vial in the connector is enabled by means of a plurality of clamping fingers distributed around the circumference of the connector, which preferably cannot be released without destruction.

[0046] Preferably, the connector comprises 4 to 10, more preferably 6 to 10, clamping fingers distributed around its circumference. The clamping fingers are preferably inclined in the insertion direction of the vial at an angle of more than 10°, preferably more than 30°, more preferably more than 40° and / or less than 80°, more preferably less than 70°, more preferably less than 60°, relative to a plane perpendicular to a central axis of the connector.

[0047] Preferably, the individual clamping fingers are designed with a tapered tip. It is particularly intended that the clamping fingers taper to a point both in the top view (in width) and that the thickness of the clamping fingers decreases towards the tip. The thickness of the clamping fingers is reduced towards the tip by flattening them on both a top and a bottom surface.

[0048] This design allows for the provision of spring-loaded clamping fingers which, after insertion of the vial, grip its cap and / or head when the vial is withdrawn, thus reliably preventing the vial from being pulled out again.

[0049] According to one embodiment of the invention, the vial receptacle comprises a funnel-shaped, in particular cup-shaped, section for inserting the vial or for inserting the head of the vial. The head of the vial is thus guided centrally to the spike during insertion.

[0050] The invention further relates, according to claim 12, to a connector for the medical packaging described above, which is described as follows: Connector for a medical packaging for providing a fluid connection between the medical packaging and a vial, wherein the connector comprises a spike for piercing a septum of the vial and a sealing element enclosing the spike, wherein the spike is rotatably formed in the connector and wherein the spike comprises a piercing section having a tip and a lateral notch in the side wall of the spike, wherein the lateral notch extends from the tip into the side wall of the spike, which ends within the piercing section, and wherein the spike has a thread which is guided in a thread of a housing part of the connector, in particular a lower part of the connector, characterized in that the spike comprises an axially extending channel which transitions into a laterally extending, preferably radially, channel with a lateral opening, wherein the lateral opening is arranged between the thread and the piercing section and adjoins the sealing element in a closed fluid connection, wherein the spike is axially displaceable by a rotational movement of the vial such that the lateral opening of the channel is moved axially out of the sealing element and the fluid connection between the vial and the medical packaging is opened.

[0051] According to a first embodiment, the connector is a component of the port of the medical packaging. The connector is permanently attached to the medical packaging. The medical packaging can be, for example, an infusion bag or an infusion bottle.

[0052] According to a second embodiment, the connector is designed as a separate adapter that can be connected to the port of a medical package. The connector includes a connecting piece that can be attached, for example, to the port of a medical package. The port may be located, for example, on an infusion bag or on the cap of an infusion bottle. The connecting piece of the connector may, for example, be a male Luer-lock connector that can be attached to a female Luer-lock connector of a medical package.

[0053] The following describes a method for providing a fluid connection between a first medical package, preferably designed as a vial, and a connector comprising a spike of a second medical package, preferably designed as an infusion bag. Preferably, the second medical package corresponds to the medical package described above. The connector, the first medical package, and / or the second medical package may have all of the aforementioned related features.

[0054] The method is described in detail as a method for providing a fluid connection between a first medical packaging, preferably designed as a vial, and a connector comprising a spike of a second medical packaging, preferably designed as an infusion bag, wherein the first medical packaging is pushed onto the connector of the second medical packaging, so that the spike pierces a septum of the first medical packaging to provide a fluid connection, preferably initially closed, to the inner volume of the second medical packaging, wherein the spike is rotated by a rotational movement of the first medical packaging and / or the connector, thereby opening the fluid connection from the first medical packaging to the second medical packaging.

[0055] In one embodiment of the invention, the spike can be rotated back by a rotary movement of the first medical packaging and / or the connector, so that the fluid connection is closed again.

[0056] According to the invention, the spike is rotated by a rotary motion of the vial, thereby opening a fluid connection to the infusion bag. The rotary actuation of the spike via the vial's septum allows for convenient opening of the fluid connection. Simultaneously, a rotation lock between the spike and the septum can be easily provided without hindering the insertion of the septum.

[0057] When opened, as described above, the spike shifts axially, whereby a lateral opening is moved out of a sealing element. Brief description of the drawings

[0058] The invention will be explained in more detail below with reference to preferred embodiments of the invention. Fig. 1 is a view of a medical packaging designed as an infusion bag with a connector and a vial, which is to be connected to the infusion bag. Fig. 2 This is a perspective view of the vial connected to the connector. Fig. 3 This is a side view of the connector (without a connected vial). Fig. 4 This is a perspective exploded view of the connector. Figs. 5 to 7 are different views of the lower part of the connector, whereby Fig. 5 a perspective view, Fig. 6 an axial sectional view and Fig. 7 This is a top view of the welded section of the lower part. Figs. 8 to 10 show the spike of the connector, where Fig. 8 It includes two side views and one perspective view. Fig. 9 an axial sectional view and Fig. 10 a radial sectional view. Figs. 11 and 12 show the sealing element of the connector, whereby Fig. 11 a perspective view of the sealing element is and Fig. 12 This is a cross-sectional view of the sealing element. Figs. 13 and 14 show the middle part of the connector, whereby Fig. 13 a perspective view of the middle part of the connector is and Fig. 14 This is a cross-sectional view of the middle part of the connector. Figs. 15 to 17 show the vial intake of the connector, whereby Fig. 15 a perspective view, Fig. 16 a top view and Fig. 17 It is a sectional view. Fig. 18a and 18b show an axial sectional view of the connector in the closed state without ( Fig. 18a ) and with attached vial ( Fig. 18b ). Fig. 19 This is an axial sectional view of the connector in the open state with a connected vial. Detailed description of the drawings

[0059] Figs. 1 to 19show an embodiment of the invention in which the spike 10 has a lateral opening 33 and is axially displaced by a rotary movement.

[0060] Fig. 1 is a representation of a medical packaging designed as an infusion bag 1, to which a vial 5 is to be connected.

[0061] The infusion bag 1 consists of films welded together via the weld seams 7 and 8. The infusion bag 1 has a hanger 9 for attaching the infusion bag 1 to a stand.

[0062] Furthermore, the infusion bag 1 includes at least one extraction port 4.

[0063] The dispensing port 4 consists of a lower part 4a welded into the weld seam 7 of the bag 1 and an upper part 4b, which has a snap-off section 4c. The dispensing port 4 also includes a septum (not shown in the figures) fixed between the lower part 4a and the upper part 4b, preferably by clamping.

[0064] After breaking off the break-off part 4c, the septum of the extraction port 4 can be pierced, for example, with a spike of an administration set, in order to extract the infusion fluid and administer it to a patient.

[0065] Furthermore, the infusion bag 1 includes port 2, which is designed as a connector 3, with which a fluid connection to a vial 5 can be established. Connector 3 comprises the lower part 3a, which in this embodiment is welded in area 6 of the weld seam 7. Further details of connector 3 are explained with reference to the following figures.

[0066] Connector 3 provides an additional access point or port 2 through which fluid can be transferred from vial 5 to infusion bag 1. It is also possible to transfer fluid from infusion bag 1 to vial 5, for example, to dissolve a solid, such as powdered, active ingredient present there, and then transfer the resulting solution back to infusion bag 1.

[0067] The vial 5 comprises a cap 12, which is designed in particular as a crimped metal cap or as a spring-loaded closure, and which includes a septum 52 (see Fig. 19 ) which can be penetrated by the spike 10 of connector 3.

[0068] To connect the vial 5 to the infusion bag 1, the sealing film 11 is first removed from the connector 3 in this exemplary embodiment. It is understood that a cap or a combination of sealing film and cap may also be provided instead of the sealing film 11 (not shown).

[0069] The vial 5 is then inserted into the connector 3 with the cap 12 leading, the funnel-shaped or, in particular, cup-shaped design of the connector 3 simplifying the centered insertion.

[0070] The septum 52 of the vial 5 is pierced by the spike 10 and the cap 12 of the vial 5, or the head of the vial 5, which is collar-shaped, locks into the connector 3 (see below). Fig 18a and 18b ).

[0071] A fluid connection between the vial 5 and the infusion bag 1 can then be opened by rotating the vial 5, which also rotates the spike 10. For this purpose, the connector 3 includes a valve which can preferably be both opened and closed by a rotary motion.

[0072] Fig. 2 Figure 1 is a perspective view of only connector 3 (without infusion bag 1) with the vial 5 connected to connector 3. The vial 5 is locked into the cup- or funnel-shaped vial receptacle 14.

[0073] In this embodiment, the lower part 3a of the connector 3 comprises a connecting section for the infusion bag 1, which is specifically designed as a weld-in section 18. In this embodiment, the weld-in section 18 is boat-shaped. A channel 17 leads through the lower part 3a of the connector 3 into the infusion bag 1.

[0074] The lower part 3a is connected to the middle part 13, the middle part 13 in turn being connected to the vial holder 14. In another embodiment, not shown, the middle part 13 and the vial holder 14 can also be formed in one piece.

[0075] Furthermore, instead of a connecting section for welding into the infusion bag 1, the lower part 3a of the connector 3 can also comprise a connector for connecting to a port, according to another embodiment. In this embodiment, which is not shown here, the connector 3 is designed as a separate adapter for a port. The connector of the connector 3 can, for example, be designed as a Luer connector or a Luer-lock connector.

[0076] Fig. 3Figure 1 is a side view of the connector 3, whose housing consists of the lower part 3, the middle part 13, and the vial receptacle 14. In this embodiment, the housing of the connector 3 is therefore formed in three parts.

[0077] The coupling section 19 is located between the lower part 3a of connector 3 and the middle part 13. The coupling section 15 is located between the middle part 13 and the vial holder 14.

[0078] The three housing components can be locked together, as will be explained in detail below.

[0079] The coupling section 15 between the middle part 13 and the vial holder 14 has a larger diameter than the coupling section 19 between the lower part 3a and the middle part 13, because the coupling section 15 is adapted to the larger vial holder 14.

[0080] The spike 10 is arranged inside the housing. It is designed as a hollow needle, preferably made of plastic, and projects into the vial receptacle 14, which is shaped in sections like a funnel or cup.

[0081] In this embodiment, the vial holder 14 includes a recess 16 at its edge. The recess 16 allows the user to see the entire internal volume of the (transparent) vial 5. This enables them, for example, to check whether the vial 5 is completely empty or whether the active ingredient is completely dissolved.

[0082] Fig. 4 Figure 1 is a perspective exploded view of the components of connector 3. In this embodiment, the components of connector 3 comprise the lower part 3a, the spike 10, the sealing element 21, the middle part 13 and the vial holder 14.

[0083] The lower part 3a of the connector 3 with the channel 17 includes the weld-in section 18 and, on the opposite side, the coupling section 19 of the lower part 3a to the middle part 13.

[0084] In the assembled state, the coupling section 19 of the lower part 3a is locked to the head piece 20 of the middle part 13.

[0085] The sealing element 21, which has the passage 25 for the spike 10, is inserted between the lower part 3a and the middle part 13. The sealing element 21 serves both to seal the infusion bag 1 and, in conjunction with the spike 10, as a valve component.

[0086] The spike 10 includes the thread 23, which, when assembled, sits in a thread 28 of the lower part 3a (see also Fig. 6 Preferably, the thread 23 of the spike 10 is designed as an external thread and the thread 28 of the lower part 3a as an internal thread.

[0087] The coupling section 15 of the central part 13 is in turn snapped onto the connecting section 24 of the vial holder 14. As already explained above, in an embodiment not shown here, the central part 13 and the vial holder 14 can also be formed in one piece.

[0088] Fig. 5 is a perspective view of the lower part 3a, which has the coupling section 19 to the middle part 13 as well as the welded section 18. Fig. 6 is an axial sectional view of the lower part 3a and Fig. 7 is a top view of the lower part 3a (as seen from the infusion bag 1).

[0089] As shown in the axial sectional view according to Fig. 6 As shown, the connecting section 19 includes the collar 26, which is locked into a corresponding groove 39 of the middle part 13 (see Fig. 14 ).

[0090] Furthermore, the coupling section 19 includes a toothing 27 which, in the assembled state, engages with a toothing 36 of the central part 13 (see also Fig. 14 ) intervenes and forms an anti-rotation device.

[0091] The end face 40 of the lower part 3a engages in the sealing element 21 in its assembled state. The end face 40 of the lower part 3c comes to rest on the top of the sealing element 21 next to the ring 34 of the sealing element 21.

[0092] The thread 28 of the lower part 3a is, as shown in particular in Fig. 7 The thread is shown as segmented. In this embodiment, the thread 28 comprises five segments.

[0093] Between the segments of the thread 28, axially extending recesses 50 are provided which, in the open state of the connector 3, in conjunction with the spike 10, form at least one axially extending channel for the passage of liquid.

[0094] Fig. 8 Figure 1 shows a first side view on the left, a second side view rotated by 90° in the middle, and a perspective view of the spike 10 on the right. In one embodiment, the spike 10 is made of plastic, for example, polycarbonate. The spike 10 includes the insertion section 29, which has a tip 30.

[0095] From the tip 30, a lateral incision 22 extends into the side wall of the spike 10, ending within the insertion section 29. This facilitates the penetration of the septum of the vial 5 and provides a large cross-section for the passage of liquid.

[0096] Between the thread 23 and the insertion section 29, the spike 10 includes a lateral opening 33 for the passage of liquid. When the connector 3 is assembled and closed, the lateral opening 33 is sealed by the sealing element 21 (see [reference]). Fig. 18a and 18b ).

[0097] The spike 10 here comprises a double-fluted thread 23, which in this embodiment has recesses 49 formed as flattening of the thread teeth. These recesses 49 are arranged axially one behind the other.

[0098] In the open state of the connector 3, the recesses 49 overlap at least partially with the recesses 50 of the thread 28 of the lower part 3a, so that at least one axially extending channel is formed for the passage of liquid.

[0099] Fig. 9 is an axial sectional view of spike 10. Spike 10 is designed, at least in sections, as a hollow needle.

[0100] The piercing section 29 of the spike 10 comprises an axially extending channel 31, which transitions in the central region of the spike 10 into a laterally, preferably radially, extending channel 32, through which the lateral opening 33 is formed. The axially extending channel 31 and the radially extending channel 32 together form the channel or passage for transferring the liquid from the vial 5 into the infusion bag 1 or from the infusion bag 1 into the vial 5.

[0101] As shown in the top view of the tip 30 of spike 10 according to Fig. 10 As shown, the insertion section 29 of the spike 10 is not round, at least in part. Preferably, the insertion section 29 of the spike 10 is polygonal, in particular trapezoidal, at least in part. This provides an anti-rotation feature when the spike 10 is inserted into the septum of the vial 5.

[0102] Fig. 11Figure 21 is a perspective view of the sealing element 21, which is made of an elastic material. The sealing element 21 includes a central passage 25, the side wall 48 of which seals around the spike 10 when assembled. When closed, the side wall 48 also seals the lateral opening 33 of the spike 10.

[0103] In this embodiment, the sealing element 21 comprises radial ribs 47 on its upper and / or lower surface (not shown in the figures), which can also serve as an anti-rotation device. However, since the sealing element 21 is firmly clamped between the lower part 3a and the middle part 13, the ribs 47 can optionally be omitted.

[0104] As shown in the section view according to Fig. 12As shown, the sealing element 21 comprises an edge ring 34, which forms a circumferential, T-shaped section of the sealing element 21 rotated by 90°. In the assembled state, this ring 34 is positively secured on one side in an end-face annular groove 37 of the central part 13 (see figure). Fig. 14 On the opposite side, the ring 34 is secured between the end face 40 of the lower part 3a, which engages the sealing element 21, and the head 20 of the middle part 13, so that a positive fit exists on both sides of the sealing element. An inner flange 35 of the sealing element 21, extending towards the middle part 13, engages in the annular section 38 of the middle part 13 (see also Fig. 14 ).

[0105] In this way, the sealing element 21 is securely fixed between the lower part 3a and the middle part 13, without any risk of being pushed out.

[0106] Fig. 13 is a perspective view of the middle part 13, which includes the coupling section 15 for the vial receptacle 14 and the head piece 20 for inserting the lower part 3a. Fig. 14 is a corresponding sectional view of the middle section 13.

[0107] The head piece 20 is designed as a coupling section 41 for inserting the coupling section 19 of the lower part 3a. For this purpose, the head piece 20 includes the groove 39 in which, in the assembled state, the collar 26 of the lower part 3a is engaged (see also Fig. 6 as well as Fig. 18a / b and 19). The head piece 20 is provided with a toothing 36 on its inner side below the radial groove 39, in which the collar 26 of the lower part 3a engages. The sealing element 21 is located in the area of ​​the toothing when assembled.

[0108] The toothing 36 acts, firstly, as a rotation protection device for the sealing element 21, which is compressed and thus pressed into the toothing 36.

[0109] Secondly, adjacent to the radial groove 39, in which the collar 26 of the lower part 3a engages, the toothing 27 of the lower part 3a engages in the toothing 36 of the middle part 13, so that the lower part 3a is also secured against rotation relative to the middle part 13 by the toothing 36 of the middle part 13.

[0110] The annular groove 37 on the end face serves, as described above, as a positive locking element for the circumferential ring 34 of the sealing element 21. The flange 35 of the sealing element 21 engages in the inner annular section 38 of the central part 13.

[0111] In this embodiment, the coupling section 15 comprises two circumferential grooves 42, in each of which a collar 43 of the vial receptacle 14 is engaged (see [reference]). Fig. 15 ).

[0112] Fig. 15is a perspective view of the vial holder 14. The vial holder 14 comprises a cup- or funnel-shaped section 44, to which the coupling piece 51 with the two collars 43 for the middle part 13 adjoins.

[0113] Furthermore, the vial receptacle 14 comprises a multitude of clamping fingers 45 inclined in the insertion direction of the vial 5.

[0114] As shown in the top view according to Fig. 16 As shown, the clamping fingers 45 taper in width from the outer base inwards. In the illustrated embodiment, they terminate in a point 46 on the inside. The outer bases of the clamping fingers 45 each merge into one another via a substantially circular section. Between the points 46, the clamping fingers 45 are rounded, in particular substantially circular.

[0115] As shown in the section view according to Fig. 17As shown, the clamping fingers 45 are inclined in the insertion direction by an angle α. The degree values ​​mentioned in the general part of the description refer to the underside of the clamping fingers 45. The angle α by which the clamping fingers 45 are inclined in the insertion direction of the vial 5 is, in particular, between 40° and 60°.

[0116] It further narrows, as can be seen particularly in the perspective view according to Fig. 15 The thickness of the clamping fingers 45 can also be seen, as they are flattened towards the tip 46 on both their upper and lower sides.

[0117] The clamping fingers 45 grip the underside of the cap 12 or the head of the vial. Once connected to the connector 3, the vial 5 cannot be removed from the connector 3 without damage.

[0118] The Fig. 18a and 18bFigure 1 shows an axial sectional view of the entire connector 3 in a closed state of the fluid connection. Fig. 18a shows connector 3 as such without vial 5. Fig. 18b Figure 1 shows connector 3 with the attached vial 5. Vial 5 is snapped into place on connector 3. In the connected state, spike 10 of connector 3 penetrates septum 52 in vial 5.

[0119] The spike 10 can be moved into an open and a closed end position by rotating the vial 5. This provides a valve for opening and closing the fluid connection between the vial 5 and the infusion bag 1.

[0120] To open and close the fluid connection, vial 5 is rotated relative to connector 3. The fluid connection can also be opened and closed by rotating connector 3 relative to vial 5.

[0121] As already explained above, show Fig. 18a and 18b The closed end position of the spike 10. In this closed position, the lateral opening 33, formed by the radial channel 32 extending from the axial channel 31 of the spike 10, is closed by the sealing element 21. Simultaneously, the sealing element 21, inserted between the lower part 3a and the middle part 13, seals the infusion bag 1 to the outside.

[0122] Fig. 19 Figure 1 shows a sectional view of vial 5 inserted into connector 3, with connector 3 now in its open state. Spike 10 pierces the septum 52 of vial 5. By rotating vial 5, spike 10 is positioned in the open end position of connector 3.

[0123] Rotating the vial 5 rotates the spike 10, which is securely locked in the septum 52 of the vial 5. This rotates the spike 10 into its open end position. As the spike 10 rotates, its thread 23 engages with the thread 28 of the lower part 4a. This causes the spike 10 to move axially, such that the radial channel 32, and thus the lateral opening 33, is moved out of the sealing element 21.

[0124] Through the side opening 33, a fluid can now flow past the thread 23 of the spike 10 via the channel 17 in the lower part 3a into the infusion bag 1 or in the opposite direction.

[0125] As described above, the segmented thread 28 of the lower part 3a, in conjunction with the recesses 49 in the thread 23 of the spike 10, allows flow along an axial channel extending from the lateral opening 33 to the channel 17. Thus, after exiting the lateral opening 33 in the lower part 3c, the liquid flows axially along the thread 23 of the spike 10.

[0126] In the open state, the spike 10 preferably comes into contact with the fluid in a final position. Preferably, the fluid connection can also be closed again by turning the vial 5 back until the spike 10 is in the Fig. 18b The final position shown for the system is reached.

[0127] The invention makes it possible to easily provide a convenient and safe connector 3 for a vial 5, for example for connecting a vial 5 to an infusion bag 1. Reference symbol list

[0128] 1 Infusion bag 2 Port 3 Connector 3a Lower part of connector 3 4 Withdrawal port 4a Lower part of withdrawal port 4 4b Upper part of withdrawal port 4 4c Breakaway part of withdrawal port 4 5 Vial 6 Area of ​​transverse weld 7 7 Transverse weld 8 Longitudinal weld 9 Hanger 10 Spike 11 Sealing foil of connector 3 12 Cap of vial 5 13 Middle part of connector 3 14 Vial receptacle of connector 3 15 Coupling section of middle part 13 to vial receptacle 14 16 Recess in vial receptacle 14 17 Channel in lower part 3a of connector 3 18 Welded section of lower part 3a of connector 3 19 Coupling section of lower part 3a to middle part 13 20 Head of the middle section 13 of the connector 3 21 Sealing element of the connector 3 22 Notch in the spike 10 23 Thread of the spike 10 24 Connecting section of the vial holder 14 25 Passage in the sealing element 21 of the connector 3 26 Collar on the lower part 3a of the connector 3 27 Toothing of the lower part 3a 28 Thread inside the lower part 3a 29 Piercing section on the spike 10 30 Tipof the spike 10 31 Axial channel in the spike 10 32 Radial channel in the spike 10 33 Lateral opening in the spike 10 34 Ring of the sealing element 21 35 Flange of the sealing element 21 36 Toothing of the middle part 13 37 End groove in the middle part 13 38 Inner annular section in the middle part 13 39 Radial groove in the middle part 13 40 End end of the lower part 3a 41 Coupling section of the middle part 13 to the lower part 3a 42 Groove in the middle part 13 43 Collar of the vial holder 14 44 Funnel- or cup-shaped section of the vial holder 45 Clamping finger of the vial holder 14 46 Tip of a clamping finger 45 47 Web on the ring 34 of the sealing element 21 48 Side wall of the passage 25 in the sealing element 21 49 Recess (or flattening) of the thread 23 of the spike 10 50 Recess of the thread 28 in the lower part 3a 51 Coupling piece of the vial holder 14 to the middle part 13 52 Septum of the vial 5

Claims

1. A medical package in the form of an infusion bag (1), which comprises a connector (3) for connecting a vial (5), wherein the connector (3) comprises a spike (10) for piercing a septum (52) of the vial (5) to provide a fluid connection to an inner volume of the infusion bag (1), wherein the spike (10) is formed so as to be rotatable in the connector (3, 60) to open the fluid connection from the vial (5) to the inner volume of the infusion bag (1), wherein the spike (10) comprises a piercing section (29) having a tip (30) and a lateral cut (22) in the side wall of the spike (10), wherein the lateral cut (22) in the side wall of the spike (10) extends from the tip (30) and ends within the piercing section (29), and wherein the spike (10) has a thread (23) which is guided in a thread (28) of a housing part of the connector (3), in particular of a lower part (3a) of the connector (3), characterised in that the spike (10) comprises an axially extending channel (31) which merges into a channel (32) extending to the side, preferably radially, with a lateral opening (33), wherein the lateral opening (33) is arranged between the thread (23) and the piercing section (29) and adjoins a sealing element (21) in a closed state of the fluid connection, wherein the spike (10) is axially displaceable by a rotary movement of the vial (5) in such manner that the lateral opening (33) is moved out of the sealing element (21) and the fluid connection from the vial (5) to the inner volume of the infusion bag (1) is opened.

2. The medical package in the form of an infusion bag (1) according to the preceding claim, characterised in that the connector (3) comprises a vial holder (14) in which the vial (5) can be latched.

3. The medical package in the form of an infusion bag (1) according to claim 1, characterised in that the thread (23) of the spike (10) is designed with at least two flights, preferably exactly two flights.

4. The medical package in the form of an infusion bag (1) according to one of the preceding claims, characterised in that the thread (23) of the spike (10) and / or the thread (28) of the housing part of the connector (3) has or have recesses (49, 50) for the passage of liquid.

5. The medical package in the form of an infusion bag (1) according to the preceding claim, characterised in that the spike (10) is designed in such manner that it sits in the pierced septum (52) of the vial (5) so as to be secured against rotation.

6. The medical package in the form of an infusion bag (1) according to one of the preceding claims, characterised in that the spike (10) extends through a lower part (3a) of the connector (3) and through a further adjoining housing part of the connector (1), in particular through a middle part (13), which is connected to the lower part (3a), wherein the lower part (3a) is sealed off from the adjoining housing part via the sealing element (21).

7. The medical package in the form of an infusion bag (1) according to one of the preceding claims, characterised in that the connector (3) is designed in such manner that the spike (10) can be moved from a closed to an open position by more than a quarter turn and / or less than a full turn, in particular by about half a turn.

8. The medical package in the form of an infusion bag (1) according to one of the preceding claims, characterised in that the connector (3) comprises a lower part (3a) with a thread (28) for the spike (10) and a middle part (13), wherein the sealing element (21) is arranged at least in the middle part (13) and wherein the lower part (3a) and the middle part (13) are latched together.

9. The medical package in the form of an infusion bag (1) according to the preceding claim, characterised in that the lower part (3a) and the middle part (13) are connected to one another so as to be secured against rotation, in particular by means of an interlocking toothing (27, 36).

10. The medical package in the form of an infusion bag (1) according to claim 2, characterised in that the vial holder (14) comprises a plurality of clamping fingers (45) inclined inwards in the insertion direction of the vial (5).

11. The medical package in the form of an infusion bag (1) according to the preceding claim, characterised in that the vial holder (14) has a funnel-shaped section (44) for inserting the vial (5).

12. A connector (3) for a medical package (1) for providing a fluid connection between the medical package (1) and a vial (5), wherein the connector (3) comprises a spike (10) for piercing a septum (52) of the vial (5) and a sealing element (21) enclosing the spike (10), wherein the spike (10) is formed so as to be rotatable in the connector (3) and wherein the spike (10) comprises a piercing section (29) having a tip (30) and a lateral cut (22) in the side wall of the spike (10), wherein the lateral cut (22) in the side wall of the spike (10) extends from the tip (30) and ends within the piercing section (29), and wherein the spike (10) has a thread (23) which is guided in a thread (28) of a housing part of the connector (3), in particular of a lower part (3a) of the connector (3), characterised in that the spike (10) comprises an axially extending channel (31) which merges into a channel (32) extending to the side, preferably radially, with a lateral opening (33), wherein the lateral opening (33) is arranged between the thread (23) and the piercing section (29) and adjoins the sealing element (21) in a closed fluid connection, wherein the spike (10) is axially displaceable by a rotary movement of the vial (5) in such manner that the lateral opening (33) of the channel (32) is moved out of the sealing element (21) and the fluid connection between the vial (5) and the medical package (1) is opened.

13. The connector (3, 60) according to the preceding claim, characterised in that the connector (3, 60) is in the form of an adapter which can be connected to a port of the medical package (1, 70), in particular with a Luer connection or a Luer lock connection, or in that the connector (3, 60) is a component of the port of the medical package (1).