Medical package designed as an infusion bag and method of transferring liquid from a vial to an infusion bag

Abstract

The present invention relates to a package designed as an infusion bag, the package comprising a connector for a vial, wherein the connector comprises a spike for piercing a septum of the vial to provide a fluid connection to an inner volume of the infusion bag. The spike is designed to be rotatable. The spike is rotated by a rotational movement of the vial and opens a fluid connection from the vial to the inner volume of the infusion bag.

Description

Technical Field

[0001] This invention relates to a medical packaging designed as an infusion bag, the medical packaging being fillable with medical fluids for infusion, parenteral nutrition, or enteral nutrition, and including a connector for connecting a vial. The invention also relates to a connector for connecting a vial to an infusion bag and a method for providing a fluid connection between the vial and the infusion bag. Background Technology

[0002] In order to transfer medical substances, especially drugs, into infusion bags, it is known to construct the ports of the infusion bags as connectors for so-called vials (also known as "Violes").

[0003] The vial is designed as a container with a latching cap or a rolled-up cap, the cap including a septum that can be pierced by a hollow needle, particularly a so-called lancet. Liquid can be supplied or withdrawn via the hollow needle or lancet. The substance stored in the vial can be, for example, a toxic drug, such as a cell inhibitor.

[0004] For example, the connector for attaching the vial can be directly attached to the infusion bag and surrounds the needle, allowing liquid to flow directly from the vial into the infusion bag and / or from the infusion bag into the vial to dissolve powder. This not only simplifies the transfer of medical substances but also improves safety by providing a closed system.

[0005] For example, such a connector for an infusion bag is shown in patent application publication WO 2012 / 101178 A1 (applicant: Fresenius KabiDeutschland GmbH). The connector includes a needle, wherein the fluid connection between the vial and the infusion bag can be opened and closed by the axial movement of the needle. After the vial is placed, the needle is clamped within a diaphragm, and thus the fluid connection can be opened and closed by the movement of the needle caused by the axial movement of the vial. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a connector that enables fluid connection between a vial and a medical package designed as an infusion bag in a simple manner.

[0007] The technical problem to be solved by the present invention has been achieved by the medical packaging designed as an infusion bag, the connector, and the method for providing fluid connection according to any one of the independent claims.

[0008] Preferred embodiments of the present invention can be found in the subject matter of the dependent claims, the description and the drawings.

[0009] This invention generally relates to medical packaging designed as an infusion bag, the medical packaging including a connector for connecting a vial. The connector includes a needle for piercing the septum of the vial to provide an initial closed fluid connection with the internal volume of the infusion bag. The fluid connection is opened by rotational movement of the needle and can be closed again if necessary.

[0010] The needle is preferably designed to be arranged, or can be arranged, within the punctured septum of the vial in a manner that prevents rotation. For this purpose, the needle may, for example, have an anti-rotation portion. The needle is preferably arranged on the central axis of the connector, particularly on the central axis of the housing.

[0011] The diaphragm of the vial can be used as an actuator for a valve that opens the fluid connection when the vial is rotated.

[0012] For this purpose, the needle may have a shape-fitting element that serves as an anti-rotation part within the punctured septum. The shape-fitting element may be specifically designed as a rib extending radially from the outer wall of the needle.

[0013] Furthermore, in one construction, the needle may include threads, which preferably occupy only a portion of the needle. Preferably, the threads have fewer than two thread lines.

[0014] In this embodiment, the needle first penetrates the diaphragm. As the needle rotates relative to the diaphragm, the threads rotate into the diaphragm. This reduces the axial force acting on the diaphragm. Specifically, the diaphragm is pulled along the direction of the needle by the threads.

[0015] Therefore, the septum can be easily pierced, as the user only needs to insert the septum until the threads engage with the septum.

[0016] The diaphragm is further widened by inserting the needle.

[0017] Because the force along the axial direction is smaller, compared with a needle without threads, there is no need to fix the diaphragm to the vial, and there is no risk of the diaphragm being pushed inward by the insertion of the needle.

[0018] In addition, the advantage of this implementation is that the threads prevent the vial from being accidentally pulled out.

[0019] The proximal end of the thread can in particular have a tip extending in the axial direction. This facilitates the thread sliding into the diaphragm. In another embodiment of the invention, the tip of the needle is arranged on a reinforcement.

[0020] The reinforcement can be formed by a thickened wall portion extending in the radial direction.

[0021] Therefore, the needle can withstand a large force when it is inserted.

[0022] The reinforcement section should ideally be oriented towards the proximal end.

[0023] Specifically, the outer contour of the needle transitions into a circular portion, which is positioned between the reinforcing portion and the portion with anti-rotation features. Therefore, a good sealing effect is achieved after puncture. Simultaneously, the needle can easily slide into the diaphragm.

[0024] The portion with the anti-rotation part preferably has the largest total outer diameter when it does not have a form-fitting element. Therefore, a sufficient seal is ensured even with a form-fitting element.

[0025] The connector can be easily turned on or off by rotating the vial that is pushed onto the needle.

[0026] Therefore, the present invention allows for a simple and reliable method of using the handle to insert the vial into the connector and to establish the fluid connection.

[0027] Specifically, it prevents the needle, once inserted into the septum, from rotating within the septum. Therefore, the needle itself forms an anti-rotation section within the septum.

[0028] This anti-rotation portion can be provided by the non-circular cross-section of the needle. In particular, the needle can have at least a partial polygonal cross-section.

[0029] In addition, the needle may have a shape-fitting element extending in the radial direction, such as at least one rib.

[0030] In one embodiment, at least one form-fitting element is arranged between the thread and the needle carrier. In this embodiment of the invention, the diaphragm first slides onto the thread.

[0031] The diaphragm is further widened by rotating the needle, which is achieved by screwing a thread into the diaphragm. The diaphragm then slides from the thread into a region with a form-fitting element. In this region, the needle preferably has a larger cross-section than its proximal end before the thread. Thus, an anti-rotation section is provided, which can transmit torque during further rotation to open the fluid connection.

[0032] The needle is specially designed to be conical.

[0033] According to one embodiment of the invention, the vial is locked inside the vial receiving part of the connector after insertion, and preferably cannot be removed again without being damaged.

[0034] The infusion bag may be filled with or contain medical fluid. Medical fluid is for medical purposes and is preferably used for intravenous administration. In a preferred embodiment, the medical fluid is therefore an infusion solution. Possible examples include:

[0035] - Sterile water;

[0036] - Salt solutions, especially those containing NaCl, KCl, CaCl and / or Mg;

[0037] - Solutions containing hydrocarbons, especially glucose solutions;

[0038] - Solutions, emulsions and / or suspensions containing nutrients for parenteral nutrition, especially containing lipids, amino acids and / or glucose;

[0039] -Colloidal solutions, especially for blood replacement therapy (e.g.) Colloidal solutions of ) and / or

[0040] - So-called premixed systems, in which active ingredients have been added to the medical fluid.

[0041] In principle, this invention can be divided into two different embodiments. Features common to both embodiments can also be combined with each other.

[0042] General description of the first embodiment of the present invention

[0043] In this embodiment of the invention, the needle is preferably arranged on a needle carrier and a fluid connection is formed on the end side.

[0044] In detail, this embodiment of the invention is described as a medical package designed as an infusion bag, the medical package including a connector for connecting a vial.

[0045] The connector includes a needle for piercing the septum of the vial to provide fluid connection to the internal volume.

[0046] The feature is that the needle is designed to be rotatable in the connector to open a fluid connection of the internal volume from the vial to the infusion bag, wherein the fluid connection is created by the rotational movement causing the opening of the channel connected to the needle to overlap with the channel of the seal.

[0047] According to a first embodiment of the present invention, a fluid connection can be created by rotating the opening of the channel connected to the needle to overlap with the channel of the sealing part.

[0048] The present invention specifically specifies that the sealing portion is used in conjunction with a preferably substantially axial channel, which is sealed at the end side when the connector is in the closed state. The rotational movement of the needle, caused by the rotation of the vial connected to the needle, causes the channel leading to the needle to overlap at the end side of the sealing portion with the preferably substantially axial channel of the sealing portion, thereby creating a fluid connection.

[0049] Therefore, this embodiment of the invention is based on end-side sealing. For example, this can be achieved by a rotatable plate including an opening that may overlap with the opening of the sealing portion. The rotatable plate may, in particular, be part of the needle carrier.

[0050] Specifically, the opening of the channel connected to the needle is radially offset relative to the axis of rotation of the needle.

[0051] The needle rotates about its central axis relative to the connector housing. The needle can be fluidly connected to the channel of the seal via a preferably radially outwardly inclined channel. Preferably, the channel of the seal is also radially offset relative to the central axis of the needle.

[0052] In a preferred embodiment of the invention, the needle is arranged on a needle carrier including a disc. The disc is rotatably arranged in front of a sealing portion, wherein the sealing portion includes a channel, preferably axially, extending through the sealing portion.

[0053] The preferred axial channel of the sealing part can overlap with the opening on or inside the disc through the rotational movement of the disc.

[0054] The opening on or inside the disc is located on the opposite side of the needle and is connected to the needle through a channel, especially an inclined channel.

[0055] The disc can be rotatably arranged between the upper and middle parts of the connector. The upper and middle parts can interlock with each other, thus ensuring simple manufacturing.

[0056] In an improved version of the present invention, the upper part is also designed as a bottle receiving part, and a retaining ring for securing the bottle is used in the inserted state.

[0057] The sealing portion is preferably located between the lower and middle portions of the connector. The lower and middle portions interlock with each other.

[0058] The lower part includes the connector connection portion, especially the soldering portion.

[0059] According to one embodiment of the invention, the connector has three basic housing components: a lower part, a middle part, and an upper part.

[0060] The housing components are preferably interlocked to eliminate the need for adhesive or welding connections.

[0061] Preferably, the sealing part is fixed between the lower and middle parts in a shape-fit manner, while the needle with a rotatable needle carrier is arranged between the middle and upper parts.

[0062] The needle and disc are specifically designed as a single plastic component. In particular, the needle and disc are designed as an injection-molded part together.

[0063] Therefore, components can be provided in a simple manner, which can be arranged within the housing of the connector and form a valve together with the seal, which is achieved by overlapping the channel of the seal with a disc having an opening that connects to the needle through a channel.

[0064] To open the connector, the needle preferably rotates only about its central axis. The opening on the needle carrier is radially offset relative to the central axis and therefore relative to the axis of rotation.

[0065] As the needle rotates, the opening on the needle carrier moves around the axis of rotation and can thus overlap with the channel of the seal, which is also radially offset relative to the axis of rotation.

[0066] Therefore, the needle only rotates when the connector is open and does not move axially. This helps to create a form fit between the septum of the vial and the needle.

[0067] In an improved embodiment of the invention, the connector includes an original labeling cap that includes a removable cap covering the needle.

[0068] The original label cap is preferably designed such that the cap includes a breakable insert.

[0069] Therefore, the cap can be designed as a break and separate from the insert.

[0070] The insertion part is preferably fixed inside the upper part of the connector.

[0071] In particular, it is conceivable to lock the insert inside the upper part of the connector before connecting the upper and middle parts.

[0072] This needle design allows it to be positioned within the punctured septum of the vial in a way that prevents rotation.

[0073] In particular, the needle has at least a non-circular cross-section, particularly preferably including an edge, and / or includes lateral shape-fitting elements, such as ribs, that allow it to be pressed or cut into the diaphragm.

[0074] The needle can be specially designed so that its cross-sectional portion is polygonal, such as trapezoidal.

[0075] Furthermore, the needle may have at least partially ribs extending radially along the needle. In particular, the ribs may be designed such that they cut into the diaphragm and thus form an anti-rotation portion.

[0076] At least one rib can be specifically designed as a rearwardly expanding wing extending from the side wall of the needle. The rib, especially the wing, can be pressed or cut into the septum of the vial and thus form a shape fit.

[0077] The connector is preferably designed such that the needle can move from the closed position to the open position by more than one-eighth of a turn and / or less than one full turn, particularly about one-quarter of a turn.

[0078] Therefore, the connector can be easily opened, and can also be easily closed again if needed, depending on the implementation. According to one embodiment of the invention, the fluid connection can preferably be closed again by a rotational movement in the opposite direction to the opening direction.

[0079] Through the fluid connection, liquid can flow from the vial into the infusion bag or from the infusion bag into the vial to, for example, dissolve the active ingredient as a powder and / or initially dilute the liquid active ingredient.

[0080] After the fluid has preferably been completely transferred into the infusion bag, the fluid connection can be closed to prevent any remaining fluid from flowing back into or remaining in the vial during the infusion.

[0081] Infusion bags are preferably formed from films welded together, particularly polypropylene films.

[0082] According to one embodiment, the connector includes a vial receiver, within which the vial or its head can be locked. In the connected state, the vial is held not only by a pin but also by the vial head locking with the connector in a retaining ring. The vial receiver is preferably designed such that the connection between the vial and the connector cannot be released again during intended use.

[0083] The lower part of the connector can be directly connected to the film of the infusion bag, for example, by making the connector include a welded boat-shaped part welded into the weld of the infusion bag.

[0084] According to another embodiment, the connector is designed as an adapter, wherein the housing portion of the connector can be coupled or connected to the port of the infusion bag, for example, via a Luer or Luer lock connection. In this configuration, the connector—preferably the lower portion of the connector rather than a welding-in connection portion—has a connecting element for attachment to the port.

[0085] According to one embodiment, the connector includes a lower portion and a middle portion, wherein a sealing element is arranged at least within the middle portion, and the lower and middle portions interlock with each other. The middle and lower portions thus readily interlock with each other during connector installation, wherein the sealing element is inserted between the middle and lower portions and held clamped. The sealing element is preferably compressed during interlocking. Rotation of the lower and middle portions relative to each other is preferably prevented, particularly by means of mutually nested form-fitting elements.

[0086] To ensure reliable placement of the sealing element, the sealing element may have a surrounding annular portion that is shaped to fit within a groove provided by the connector housing. The groove in the housing may specifically include a lower portion within a lower section and an upper portion within a middle section.

[0087] The sealing element is made of at least an elastic material, particularly polyisoprene, bromobutyl or chlorobutyl.

[0088] The needle is preferably made of plastic. In particular, the needle is made of a rigid material that serves as the housing component of the connector, especially a rigid material that serves as the lower part of the connector. Therefore, the needle can be easily inserted into the diaphragm.

[0089] Specifically, the needle is made of polycarbonate. This material is rigid and can withstand autoclaving. The housing components of the connector, particularly the lower, middle, and / or upper parts and its vial receiving portion, are preferably made of polypropylene.

[0090] In an improved embodiment of the invention, the connector includes an indicator indicating whether the connector is open or closed.

[0091] The connector may specifically include at least one side window through which an indicator can be seen in the open or closed position of the connector.

[0092] In embodiments where the connector can be both open and closed, the connector housing preferably includes two windows, allowing the user to easily identify whether the connector is open or closed based on which window the indicator is visible through.

[0093] In another embodiment, the needle or the component connected to the needle is locked in the open state so that the needle cannot be turned back, and the connector may include only a window indicating that the connector is in the open state.

[0094] According to a preferred embodiment of the invention, the indicator is arranged on a spring, which allows the indicator to engage within a window when the connector is in an open and / or closed state.

[0095] In this way, the optical readability of the indicator can be improved, because the indicator is visible in or out of the window formed by the opening in the housing wall.

[0096] An acoustic signal, such as a clicking sound, can be generated by snapping an indicator into the window to acoustically notify the user that the connector is in the open position.

[0097] In addition, an indicator arranged on the spring can provide perceptible resistance that must be overcome when the vial is rotated in order to remove the needle from the open and / or closed position.

[0098] In one embodiment where the connector is designed to lock in the previously opened position, locking can also be provided by an indicator, for example by designing the indicator as a hook that locks with the window and thus prevents the needle from turning back or the component connected to the needle from turning back.

[0099] General description of the second embodiment of the present invention

[0100] A second embodiment of the present invention includes an axially movable needle.

[0101] In detail, this embodiment of the invention is described by way of a medical package designed as an infusion bag, the medical package including a connector for connecting a vial.

[0102] The connector includes a needle for piercing the diaphragm of the vial to provide fluid connection to the internal volume of the infusion bag.

[0103] The characteristic feature is that the needle is designed to rotate within the connector and includes a channel with a side opening that abuts a sealing element when the fluid connection is closed, preferably abutting the sealing element of the connector.

[0104] The needle can move axially through the rotation of the vial, causing the side opening to move away from the sealing element and opening the fluid connection between the vial and the internal volume of the infusion bag.

[0105] The fluid connection can also preferably be closed again by rotational movement in the opposite direction. Through the fluid connection, liquid can flow from the vial into the infusion bag or vice versa, for example, to dissolve the active ingredient as a powder and / or initially dilute the liquid active ingredient.

[0106] After the preferred complete transfer of fluid into the infusion bag, the fluid connection can be closed to prevent any remaining portion of the infusion fluid from flowing back into the vial during infusion, transport, and / or further operations and from remaining in the vial.

[0107] Infusion bags are preferably formed from films welded together, particularly polypropylene films.

[0108] The needle, also known as a hollow needle, includes an axial channel through which liquid can flow upwards to the side opening.

[0109] With the fluid connection closed, the side opening is preferably sealed by an annular sealing element. This achieves a good and secure seal. The side opening can have a large opening cross-section, particularly exceeding 2 mm. 2 The open cross-section.

[0110] The valve formed by the connector operates comfortably and safely. Furthermore, the needle can be easily constructed to prevent rotation relative to the diaphragm of the vial (which rotates the needle), since the rotational motion is perpendicular to the direction of insertion. The anti-rotation section between the needle and the diaphragm makes insertion into the diaphragm easy.

[0111] Rotation of the vial causes the needle to rotate within the connector. This rotation is a relative rotation of the vial with respect to the connector housing and / or to the medical packaging, preferably designed as an infusion bag. Therefore, the needle can also be rotated by rotating the medical packaging and / or the connector relative to the vial.

[0112] According to one embodiment, the connector includes a vial receiver, within which the vial or its head can be locked. Therefore, the vial is not only secured by the pin in the connected state, but the vial head is also mechanically locked to the connector by forming a retaining ring. Preferably, the vial receiver is designed such that the connection between the vial and the connector cannot be released again during intended use.

[0113] The needle preferably includes threads, particularly external threads, which are guided within the threads of the connector housing portion, particularly internal threads, especially within the internal threads of the lower portion of the connector.

[0114] When viewed from the small bottle, the thread used to generate axial displacement through rotational motion is preferably located behind the side opening.

[0115] Specifically, the needle includes threads and an insertion portion with a tip, wherein a side opening is preferably located between the insertion portion and the threads.

[0116] The lower part of the connector can be directly connected to the film of the infusion bag, for example, by making the connector include a welded boat-shaped part welded to the weld of the infusion bag.

[0117] According to another embodiment, the connector is designed as an adapter, wherein the housing portion of the connector can be coupled or connected to the port of the infusion bag, for example, via a Luer connection or Luer lock connection. In this configuration, the connector—preferably the lower portion of the connector rather than a connecting portion for soldering—has a connecting element for attachment to the port.

[0118] The thread is preferably designed as at least two parts, and particularly preferably as exactly two parts. Therefore, relatively large axial displacements can be achieved easily during rotational motion, especially axial displacements exceeding 2 mm during half a rotation.

[0119] In a preferred embodiment of the invention, the threads of the needle and / or the housing portion of the connector include openings for liquid passage. Therefore, liquid can flow through the threads over a large free cross-section.

[0120] The threads of the housing component can be specifically designed as segmented threads. This provides a gap within the thread or along the thread line. This gap allows for the formation of an axial channel within the thread, which extends along the inside of the housing component, preferably along a channel within the lower part of the connector.

[0121] The threads of the needle preferably also include at least one, preferably multiple, axially extending slots. These slots can be specifically designed as flat portions of thread teeth. In the open state of the connector, the slots in the threads on the needle at least partially overlap with slots in the threads within the connector housing portion. Thus, an axially extending channel is formed within the threads. Therefore, an axial fluid connection from the side opening to the infusion bag is achieved.

[0122] The needle is preferably designed such that it is positioned within the septum of the vial in a rotation-resistant manner. This is achieved, in particular, by a cross-section that is not circular. Specifically, the needle may have a cross-section that is at least partially polygonal, particularly trapezoidal, in the region of the vial's septum in the inserted state.

[0123] In a preferred embodiment of the invention, the needle extends through the lower part of the connector and through another adjacent housing portion of the connector, particularly through the middle portion connected to the lower part, wherein the lower part is sealed relative to the adjacent housing portion by a sealing element.

[0124] Therefore, the sealing element not only seals the side opening of the needle 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 specifically located between the lower part and the middle part of the connector housing.

[0125] The connector is preferably designed such that the needle moves from the closed position to the open position by a quarter turn or more, and / or less than a full turn, particularly about half a turn.

[0126] According to one embodiment, the connector includes a lower portion and a middle portion with threads for a needle, wherein a sealing element is arranged at least within the middle portion, and the lower and middle portions interlock. The middle and lower portions thus simply interlock during connector installation, wherein the sealing element is inserted between the middle and lower portions and held clamped. The sealing element is preferably compressed during interlocking. The lower and middle portions are preferably anti-rotationally secured to each other, particularly by means of interlocking teeth.

[0127] To ensure secure placement of the sealing element, a sealing element with a surrounding annular portion can be used, which is shaped to fit within a groove provided by the connector housing. The groove in the housing may specifically include a lower portion located within the lower part of the connector and an upper portion located within the middle part of the connector.

[0128] The sealing element is made of at least an elastic material, particularly TPE (thermoplastic elastomer), polyisoprene, EPDM (ethylene-propylene-diene rubber), brominated butyl rubber, or chlorobutyl rubber.

[0129] The needle is preferably made of plastic. In particular, the needle is made of a rigid material that serves as the housing component of the connector, especially a rigid material that serves as the lower part of the connector. Therefore, the needle can be easily inserted into the diaphragm.

[0130] Specifically, the needle is made of polycarbonate. This material is rigid and can withstand autoclaving. The housing components of the connector, particularly the lower, middle, and / or upper parts and the vial receiving section, preferably comprise polypropylene.

[0131] The present invention also relates to medical packaging designed as infusion bags, particularly medical packaging having one or more of the features described above. The infusion bag includes a connector comprising a needle for piercing the septum of a vial to provide fluid connection to the internal volume of the infusion bag. According to the invention, the connector includes a vial receiving portion having a plurality of clamping fingers angled inwardly along the vial insertion direction.

[0132] According to this aspect of the invention, a plurality of clamping fingers distributed on the periphery of the connector achieve a reliable locking of the vial within the connector, the locking preferably being unable to be released without being damaged.

[0133] The connector preferably includes 4 to 10, particularly preferably 6 to 10, clamping fingers distributed around its periphery. The clamping fingers are preferably inclined at an angle greater than 10°, preferably greater than 30°, particularly preferably greater than 40° and / or less than 80°, preferably less than 70°, particularly preferably less than 60°, relative to a plane perpendicular to the central axis of the connector along the insertion direction of the vial.

[0134] The individual clamping fingers are preferably configured to taper towards the tip. Specifically, the clamping fingers are tapered in width in a top view, and the thickness of the clamping fingers decreases towards the tip. The thickness of the clamping fingers decreases particularly towards the tip, which is achieved by the clamping fingers flattening towards the tip on both the upper and lower sides.

[0135] This structure provides a slightly inwardly elastically extending clamping finger that grips the cap and / or head of the vial when it is pulled out after insertion, thus reliably preventing the vial from being pulled out again.

[0136] According to one embodiment of the invention, the vial receiving portion includes a funnel-shaped, particularly cup-shaped, portion for introducing the vial or for introducing the head of the vial. Therefore, the head of the vial is centered and guided toward the needle during introduction.

[0137] The present invention also relates to a connector for medical packaging, and more particularly to a connector for the aforementioned medical packaging. This connector may have all the connector-related features described above.

[0138] In detail, according to one embodiment, the invention is also described by a connector for medical packaging, the connector being used to provide a fluid connection between the medical packaging and a vial, wherein the connector includes a needle for piercing a diaphragm of the vial and a sealing element surrounding the needle, characterized in that the needle is designed to be rotatable in the connector and includes a channel with a side opening, the channel abutting or resting on the sealing element in a closed fluid connection, wherein the needle is axially movable by rotational movement of the vial, such that the side opening of the channel moves axially away from the sealing element and opens the fluid connection between the vial and the medical packaging.

[0139] In detail, according to one embodiment, the invention is also described by means of a connector for medical packaging, the connector being used to provide a fluid connection between the medical packaging and a vial, wherein the connector includes a needle for piercing a septum of the vial, characterized in that the needle is arranged on a needle carrier including a disc, wherein the disc is rotatably arranged in front of a seal, wherein the seal includes an axial channel, wherein by rotational movement of the disc, the axial channel of the seal can overlap with an opening on the disc, and thus open the fluid connection between the vial and the medical packaging.

[0140] According to one construction, the invention can also be described via a connector for medical packaging, the connector providing a fluid connection between the medical packaging and a vial, wherein the connector includes a needle for piercing the septum of the vial, the needle including threads, the threads preferably occupying only a portion of the needle. The threads preferably have fewer than two thread lines.

[0141] According to one configuration, the invention can also be described via a connector for medical packaging, the connector being used to provide a fluid connection between the medical packaging and a vial, wherein the connector includes a needle for piercing the septum of the vial, the tip of the needle being disposed on a reinforcement.

[0142] According to the first embodiment, the connector is a port component of the medical packaging. The connector is permanently connected to the medical packaging. The medical packaging can be designed as, for example, an infusion bag or infusion bottle.

[0143] According to a second embodiment, the connector is designed as an initially separate adapter that can be connected to a port on the medical packaging. The connector includes a connecting element that can, for example, connect to a port on the medical packaging. For example, the port may be located on an infusion bag or on a cap of an infusion bottle. The connecting element of the connector may be designed, for example, a male Luer lock connector that can connect to a female Luer lock connector on the medical packaging.

[0144] The present invention also relates to a method for providing a fluid connection between a first medical package, preferably designed as a vial, and a second medical package, preferably designed as an infusion bag, and a connector including a needle. The second medical package preferably corresponds to the aforementioned medical package. The connector, the first medical package, and / or the second medical package may have all the aforementioned related features.

[0145] In detail, the invention is described by a method for providing a fluid connection between a first medical package, preferably designed as a vial, and a second medical package, preferably designed as an infusion bag, and a connector including a needle, wherein the first medical package is pushed onto the connector of the second medical package such that the needle pierces the septum of the first medical package to provide a fluid connection to the internal volume of the second medical package, preferably initially closed, characterized in that the needle is rotated by rotational movement of the first medical package and / or the connector, and thereby opens the fluid connection from the first medical package to the second medical package.

[0146] In one embodiment of the invention, the needle can be rotated back by the rotational movement of the first medical packaging and / or connector, thereby closing the fluid connection again.

[0147] According to the present invention, the needle is rotated by the rotational movement of the vial, thereby opening the fluid connection with the infusion bag. The fluid connection is easily opened by rotating the needle on the septum of the vial. Simultaneously, an anti-rotation portion can be provided between the needle and the septum in a simple manner without making septum puncture difficult.

[0148] According to a first embodiment, the needle as described above is arranged on a needle carrier including a disc. The disc is rotatably arranged in front of a sealing portion. The sealing portion includes an axial channel. On the side facing the needle, the disc includes an opening through which the channel leads to the needle. By rotational movement of the disc, wherein the needle drives the disc via the diaphragm of the vial, the axial channel can overlap with the opening on the disc to thus open a fluid connection between the vial and the medical packaging.

[0149] According to the second embodiment, as described above, the needle moves axially when opened, wherein the side opening moves away from the sealing element. Attached Figure Description

[0150] The invention will now be explained in more detail with reference to preferred exemplary embodiments.

[0151] Figures 1 to 24 A first embodiment of the invention is shown, wherein the vial is arranged on a rotatable disk.

[0152] Figure 1 This is a view of medical packaging designed as an infusion bag.

[0153] Figure 2 This is a perspective view of the connector.

[0154] Figure 3 This is an exploded perspective view of the connector.

[0155] Figures 4 to 6 This is a detailed illustration of a needle carrier with a needle. Here, Figure 4 It is a perspective view. Figure 5 It's a rear plan, and Figure 6 It is a cross-sectional view.

[0156] Figure 7 This is a perspective view of the middle part of the connector, and Figure 8 It is a cross-sectional view.

[0157] Figure 9 This is a cross-sectional view of the sealing part.

[0158] Figure 10 This is a perspective view of the lower part.

[0159] Figures 11 to 13 The upper part is shown in detail. Figure 11 It is a perspective view. Figure 12 It is a top view, and Figure 13 It is a cross-sectional view.

[0160] Figure 14 It is a perspective view of the original logo cover designed as a hat.

[0161] Figures 15 to 17 An alternative embodiment of the invention is shown, wherein the middle portion of the connector housing and the needle carrier interact to prevent the needle from rotating and to lock the needle in the open position.

[0162] Figure 15 This is a perspective view of the middle section used for this purpose.

[0163] Figure 16 It is a top view of the middle section from below.

[0164] Figure 17 It is a perspective view of a needle carrier with a needle attached.

[0165] Figure 18 yes Figures 1 to 14 The figure shows a cross-sectional view of the connector in the closed state.

[0166] Figure 19 This is a cross-sectional view of the connector in the open position.

[0167] Figure 20 The invention is shown in particular relative to Figures 1 to 14 A modified implementation wherein the needle indicator is not locked in the end position, and wherein the needle has an additional construction.

[0168] Figure 21 This is a perspective detail view of the middle part of this embodiment.

[0169] Figure 22 and Figure 23 This is a detailed view of the needle along with its carrier.

[0170] Figure 24 This is a detailed perspective view of the connector cap.

[0171] Figure 25 The connector is shown with supplementary markings to indicate the open and closed states, and the connector can be moved from one state to another by rotational movement.

[0172] Figure 26 Show Figure 25 A perspective view of the connector.

[0173] Figure 27 and Figure 28 This is a longitudinal cross-sectional view of the connector in the closed state.

[0174] refer to Figures 29 to 36 Another embodiment of the invention is explained, wherein the needle does not have threads, but is provided with a reinforced tip.

[0175] Figure 29 and 30 It is a side view.

[0176] Figure 31 It is along Figure 29 The longitudinal section view of section line AA, and Figure 32 It is along Figure 30 The longitudinal section view of section line BB.

[0177] Figure 33 The perspective view shows the needle carrier with the needle.

[0178] Figure 34This is a side view of a needle carrier with a needle attached.

[0179] Figure 35 It is along Figure 34 The longitudinal section view of the cross-section line CC.

[0180] Figure 36 This is a top view of the needle carrier with the needle, viewed from a remote position.

[0181] Figure 37 This is a flowchart of an embodiment of the method according to the present invention.

[0182] Figure 1 'to Figure 19 A second embodiment of the invention is shown, wherein the needle has a side opening and moves axially by rotational motion.

[0183] Figure 1 This is a view of a medical package designed as an infusion bag, with a connector and a vial that should be connected to the infusion bag.

[0184] Figure 2 'This is a perspective view of the vial connected to the connector.'

[0185] Figure 3 'This is a side view of the connector (without the vial connected).

[0186] Figure 4 'This is an exploded perspective view of the connector.

[0187] Figure 5 'to Figure 7 'These are different views of the lower part of the connector, in which Figure 5 It is a perspective view. Figure 6 'It is a longitudinal section view, and Figure 7 'This is a top view of the lower welded section.

[0188] Figure 8 'to Figure 10 The connector's piercing needle is shown, in which Figure 8 Includes two side views and a perspective view. Figure 9 'This is an axial section view, while Figure 10 'This is a cross-sectional view.'

[0189] Figure 11 'and Figure 12 The sealing element of the connector is shown, wherein... Figure 11 'This is a perspective view of the sealing element, and Figure 12 'This is a cross-sectional view of the sealing element.

[0190] Figure 13 'and Figure 14 The middle part of the connector is shown, where Figure 13 'This is a perspective view of the middle part of the connector, and...' Figure 14 'This is a cross-sectional view of the middle part of the connector.

[0191] Figure 15 'to Figure 17 The connector's vial receiving section is shown, in which... Figure 15 It is a perspective view. Figure 16 'It is a top view, and Figure 17 'This is a cross-sectional view.'

[0192] Figure 18 a' and Figure 18 b' indicates the unconnected vial ( Figure 18 a') and connected to a small bottle ( Figure 18 a cross-sectional view of the connector in the closed state (b').

[0193] Figure 19 'This is a cross-sectional view of the connector with the vial attached, in the open position. Detailed Implementation

[0194] Figures 1 to 24 A first embodiment of the invention is shown, wherein a vial 90 is arranged on a rotatable disk 404.

[0195] Figure 1 This is an illustration of a medical package designed as an infusion bag 70, to which a vial 90 should be attached.

[0196] The infusion bag 70 is made of a thin film welded together by a transverse weld 71 and a longitudinal weld 72. The infusion bag 70 has a suspension part 73 for attaching the infusion bag 70 to a support.

[0197] The infusion bag 70 also includes at least one dispensing port 80.

[0198] The fluid dispensing port 80 is formed by a lower portion 81 welded within a transverse weld 71 of the infusion bag 70 and an upper portion 82 having a broken portion 83. In addition, the fluid dispensing port 80 also includes a diaphragm (not shown) fixed between the lower portion 81 and the upper portion 82, which is preferably fixed between the lower portion 81 and the upper portion 82 by a clamping method.

[0199] After the fractured portion 83 is broken, the diaphragm of the fluid extraction port 80 can be punctured, for example, using the needle of a transfer device, to extract the infusion fluid and deliver it to the patient.

[0200] Furthermore, the infusion bag 70 includes another port designed as a connector 60, which allows for a fluid connection with the vial 90. The connector 60 includes a lower portion 100, which in this embodiment is welded within region 74 of a weld 71. Further details regarding the connector 60 are explained with reference to the following figures.

[0201] A further passage or port is provided via connector 60 through which liquid can be transferred from vial 90 to infusion bag 70. Alternatively, liquid can be first transferred from infusion bag 70 to vial 90, for example, to dissolve solid, such as powdered, active ingredients stored in vial 90, and the resulting solution can then be transferred back to infusion bag 70.

[0202] The vial 90 includes a cap 91, which is specifically designed as a rolled-edge metal cap or a latch cap, and the cap includes a diaphragm that can be pierced by a needle of the connector 60.

[0203] In this embodiment, to connect the vial 90 to the infusion bag 70, the cap 500 is first removed from the connector 60.

[0204] Then, the vial 90, along with the cap 91, is first pushed into the connector 60, whose funnel-shaped or, in particular, cup-shaped construction simplifies the introduction of the center.

[0205] The diaphragm of vial 90 is pierced by the needle 401 of connector 60, and the cap 91 of vial 90 or the head of vial 90 designed as a snap ring is locked inside connector 60.

[0206] Then, the fluid connection between the vial 90 and the infusion bag 70 can be established by rotating the vial 90—which also rotates the needle 40. For this purpose, the connector 60 includes a valve that can preferably be opened and closed by rotational movement.

[0207] Figure 2 This is a perspective view of the connector 60 without the infusion bag 70.

[0208] In this embodiment, the lower portion 100 of the connector 60 includes a connection portion for the infusion bag 70, which is specifically designed as a soldered portion 101. The soldered portion 101 is designed in a boat shape in this embodiment. A channel 102 leads into the infusion bag 70 through the lower portion 100 of the connector 60.

[0209] The lower part 100 is connected to the middle part 200, and the middle part 200 itself is connected to the small bottle receiving part 301 of the upper part 300.

[0210] Furthermore, according to another embodiment, the lower portion 100 of connector 60 may also include a connector for attachment to a port, as an alternative to a connection portion for soldering into the infusion bag 70. In this embodiment, not shown here, connector 60 is designed as a separate adapter for the port. The connector of connector 60 may be designed, for example, a preferred male Luer connector or a Luer lock connector.

[0211] Figure 3 yes Figure 2 The exploded perspective view of connector 60 shown in the figure.

[0212] The housing of connector 60 includes a lower part 100, a middle part 200, and an upper part 300.

[0213] Preferably, the lower part 100 and the middle part 200, as well as the middle part 200 and the upper part 300, interlock with each other. The connector 60 can therefore be installed without soldering or adhesive bonding.

[0214] The sealing part 600 is inserted between the lower part 100 and the middle part 200.

[0215] In the installed state, the needle carrier 400 with the needle 401 is inserted between the middle part 200 and the upper part 300.

[0216] In the installed state, the cap 500 is inserted from below into the upper part 300, which is designed as a break and therefore serves as an original marking cover.

[0217] The upper part 300 includes a funnel-shaped vial receiving section 301, which facilitates the insertion of vials 90. Once inserted, the vial 90 is locked inside the vial receiving section 301 and cannot be removed again.

[0218] The middle section includes windows 201 and 202, which allow users to identify whether connector 60 is on or off.

[0219] To open and close connector 60, needle carrier 400 is rotated via needle 401 connected to vial 90, for example, about a quarter turn in this embodiment.

[0220] In this perspective view, a stop 207 for the needle carrier 400 is visible on the inner wall of the middle 200, which restricts the rotational movement of the needle carrier 400.

[0221] Figure 4 This is a perspective view of a needle carrier 400 with a needle 401.

[0222] The needle carrier 400 includes a disc 404 and cooperates with the sealing portion 600 to form a valve to at least open the connector 60.

[0223] The needle carrier 400 shown in this illustration is provided as one embodiment for the connector 60, wherein the connector 60 can be opened and closed again.

[0224] The advantage of this embodiment of the invention is that it prevents the medical fluid from flowing back into the vial 90 during the application of the medical fluid.

[0225] The disc 404 and the needle 401 are preferably designed as one-piece plastic parts, particularly plastic injection molded parts.

[0226] The needle 401 extends in a tapered direction toward the tip 402. The tip 402 is preferably sharp so that the diaphragm inside the vial 90 can be easily pierced.

[0227] Opposite to the tip 402, the needle 401 includes a cut 403, which preferably extends into the middle region of the needle 401. The side cut 403 facilitates the passage of liquid and also enables the near-complete emptying of the vial 90.

[0228] A reinforcing ridge 405 is located at the base of the needle 401, reinforcing the needle 401 at the boundary between the upper side of the disc 404 and the needle 401. In the inserted state, the reinforcing ridge 405 can also serve as a stop for the cap 91 of the vial 90. The reinforcing ridge extends as a ridge from the base of the needle 401, extending in a star-shaped manner along the upper side of the disc 404.

[0229] The needle 401 also includes radially extending ribs 414. The radially extending ribs 414 are specifically designed as fins extending from the front or middle of the needle 401, tapering forward and expanding radially along the direction of the disc 404.

[0230] Rib 414 can cut into the septum of vial 90, thus forming an anti-rotation part.

[0231] The resulting anti-rotation section benefits from the fact that the needle carrier 400 does not move axially when the needle 401 rotates together with the needle carrier 400. Therefore, the rib 414 remains at a certain height when the connector 60 is open. When the diaphragm of the vial 90 is inserted into the connector 60, the diaphragm can be pushed as far as possible onto the needle 401. This maximum pushing position generally does not change as the needle 401 rotates.

[0232] The disc 404 also includes at least one stop 406, and more particularly two stops 406, which cooperate with the stop 207 of the center 200 to restrict the rotational movement of the needle carrier 400 together with the needle 401. At least one stop 406 of the disc 404 is designed as a radial step within the outer periphery of the disc 404.

[0233] The disk 404 also includes a radially outwardly extending indicator 407, which is visible in the closed state through a window 201 of the center 200 of the connector 60 and in the open state through another window 202 of the center 200 of the connector 60.

[0234] To improve its visibility, the indicator 407 preferably has a different color from the center of the window or windows 201, 202 adjacent to it.

[0235] The indicator 407 is designed to protrude into windows 201, 202 that are designed as openings in the housing wall, and to spring back when the needle carrier 400 rotates together with the needle 401.

[0236] Therefore, the indicator 407 can provide significant resistance, which must be overcome for the needle carrier 400 to move away from an (open or closed) end position.

[0237] The indicator 407 can also be configured to produce an audible noise, particularly a clicking noise, when it snaps into one of the windows 201, 202. This provides an optical and acoustic signal to the user that the connector 60 is, for example, in the open end position. Furthermore, a recess 407a is arranged within the outer periphery of the disk 404. The recess 407a serves to indicate point 202 (open). In the closed state, the recess 407a is offset rearward at position 202 to better distinguish positional differences.

[0238] Figure 5 It is a bottom view of the lower side of the needle carrier 400, that is, a top view on the side opposite the needle 401.

[0239] Two stops 406 restrict the rotatability of the needle carrier 400 together with the needle 401 in two rotational directions, for example, to about a quarter turn.

[0240] In the open state, liquid can flow through the opening 408 along the direction of the needle 401, the opening 408 being radially offset relative to the rotation axis 415 of the needle 401. Therefore, as the needle 401 rotates, the opening 408 moves about the rotation axis 415, and when the connector 60 is in the open state, the opening 408 overlaps with the channel 601 of the sealing portion.

[0241] In the top view, the indicator 407 is connected to the spring 409 on both sides via the arcuate portion 410, wherein the spring 409 is connected to the disc 404. The radially inwardly elastic indicator 407 is designed such that there is a cutout area 416 behind the spring 409, the indicator 407 and the arcuate portion 410, wherein the plate formed by the disc 404 is cut out.

[0242] The indicator 407 and the spring 409 are thus formed from the remaining sidewalls of the disc 404. The spring 409 is specifically designed as a leaf spring, as the hollowed-out area 416 states that the spring 409 is formed from the remaining sidewalls of the disc 404.

[0243] The indicator 407 is visible from the side of the ring formed by the disc 404 and can be popped into the windows 201, 202 of the middle 200 in the end position.

[0244] The indicator 407 is integrally formed with the remainder of the needle carrier 400.

[0245] The bow-shaped portion 410 reduces the stress within the material when the spring deforms because the deformation can be distributed over a longer portion of the material.

[0246] According to Figure 6 As illustrated in the longitudinal cross-sectional view, the opening 408 transitions into the needle 401 through a channel 411 extending transversely to the channel 412 of the needle 401. The channel 411 can particularly converge into the channel 412 of the needle 401 at an angle of 30° to 60°.

[0247] Through the laterally oriented channel 411, the opening 408 on the disk 404 is arranged to be radially offset relative to the axis of rotation 415.

[0248] The channel 412 of the needle 401 is preferably coaxial with the axis of rotation of the needle carrier 400. Therefore, when the connector 90 is open, the vial 90 connected to the needle 201 rotates essentially only around its own central axis.

[0249] In this embodiment, disk 404 further includes a rotating disk 413. The rotating disk 413, within which the opening 408 is located, protrudes as a circular plate and, in the installed state, is located within the receiving portion 211 of the center 200 (see [reference]). Figure 8 In the closed state of connector 60, the surface of rotating disk 413 rests sealingly against sealing portion 600, thus closing the channel 601 within sealing portion 600. Through the rotational movement of needle 401, opening 408 overlaps with channel 601 of sealing portion 600. Thus, liquid can flow through channel 412 of needle 401 into infusion bag 70 via opening 408 (or vice versa).

[0250] Figure 7 This is a perspective view of the middle portion 200. In this exemplary embodiment, the middle portion 200 consists of a connecting portion 203 for the upper portion 300 and a connecting portion 204 for the lower portion 100.

[0251] The diameter of the connecting portion 204 for the lower part 100 is smaller than the diameter of the connecting portion 203 for the upper part 300.

[0252] The connecting portion 204 includes a sealing portion receiving portion 205 for the sealing portion 600. In this embodiment, the sealing portion receiving portion 205 is provided with a structured wall, particularly a corrugated or serrated wall, which results in a shape fit with the lower portion 100 and / or the sealing portion 600, and thus provides an anti-rotation portion.

[0253] The sealing receiving part 205 is arranged radially offset relative to the rotation axis 415 of the needle 401 or the needle carrier 400.

[0254] In the embodiment shown here, a sickle-shaped notch 206 may be located within the connecting portion 204, adjacent to the sealing receiving portion 205. The notch 206 is primarily for material saving. Of course, the notch 206 can also be omitted.

[0255] According to Figure 8 As shown in the axial cross-sectional view of the middle portion 200, the groove 209, designed as an annular groove, is adjacent to the sealing receiving portion 205, and the lower portion 100 with corresponding ribs 105 is locked within the groove 209 (see...). Figure 10 ).

[0256] The sealing receiving portion 205 includes an axially extending annular groove 210 on its end side, which serves as a shape-fitting element for the sealing portion 600.

[0257] In this embodiment, the connecting portion 203 for the upper portion 300 with the vial receiving portion 301 also includes at least one groove 208, specifically two mutually spaced grooves 208, so that it can be locked with the connecting member 303 of the upper portion 300 by at least one retaining ring 304.

[0258] In the installed state, the disc 404 of the needle carrier 400 is located between the upper part 300 and the middle part 200. In the installed state, the rotating disc 413 is placed inside the receiving part 211 of the middle part 200.

[0259] The stop 207 cooperates with the stop 406 of the needle carrier 404 to restrict the rotation of the needle 401 in two rotational directions. The open and closed positions of the connector 60 are defined by one of the stops 406 of the needle carrier 400 resting against the stop 207 in the middle.

[0260] Figure 9 This is an axial cross-sectional view of the sealing part 600.

[0261] The sealing part 600 includes an axial channel 601 for liquid passage.

[0262] The sealing portion 600 includes, on its end side, a resting surface 602 for the disk 404, or more precisely, for the rotating disk 413, which rests on the sealing portion 600 in a sealing manner in the closed state. In the open state, the opening 408 of the rotating disk 413 overlaps with the channel 601 of the sealing portion 600.

[0263] The sealing part 600 has an axially extending annular groove 603 adjacent to the resting surface 602, such that an axially forward extending annular edge side rib 604 is formed adjacent to the annular groove.

[0264] The edge side rib 604 serves as a form-fitting element and is placed in the annular groove 210 of the center 200 in the installed state.

[0265] The rib 604 retracts relative to the resting surface 602 of the needle carrier 400 or the rotating disk 413 of the needle carrier 400.

[0266] On the side opposite to the placement surface 602, there is also an annular, edge-side protruding rib 605, which is adjacent to the receiving area 606 for the lower part 100.

[0267] The ribs 604 on the lower annular edge side and the ribs 604 on the upper annular edge side together form a substantially T-shaped flange for securing the seal within the connector 60.

[0268] There is a transition region 607 between the receiving area 606 and the channel 601 for the lower part 100, in which the bottom of the horizontal direction of the receiving area 606 transitions in a stepped manner into the axially extending sidewall of the channel 601.

[0269] Figure 10 This is a perspective view of the lower 100.

[0270] In the installed state, the lower part 100 is locked in the annular groove 209 of the middle part 200 by the annular rib 105.

[0271] To clamp the sealing portion 600, the lower portion 100 includes a rib 104 adjacent to the rib 105 and a ring 106 for engaging with the receiving area 606 of the sealing portion 600. The end side of the rib 104 rests against the upper side of the annular edge side piece 605 of the sealing portion 600. Furthermore, in this embodiment, the rib 104 is provided with structured portions, particularly corrugations or teeth, to cooperate with the corrugations or teeth within the sealing portion receiving portion 205 to prevent rotation of the lower portion 100, the middle portion 200, and / or the sealing portion 600.

[0272] In the installed state, the axially forward-extending ring 106 is arranged adjacent to the rib 104 in the receiving area 606 of the sealing portion 600, and thus presses the sealing portion 600 into the sealing portion receiving portion 205.

[0273] The plate 103, which exists between the welded portion 101 and the protruding rib 106, closes the middle part 200 of the housing in the installed state.

[0274] The welded portion 101 preferably has a central axis that coincides with the rotation axis 415 of the needle 401.

[0275] On the other hand, the sealing portion 600 and the connecting portion formed by the protruding rib 105 for locking are arranged radially offset relative to the rotation axis 415.

[0276] The end of the channel 107 extending through the lower part 100 is radially offset relative to the axis of rotation 415 of the needle 401 or the needle carrier 400.

[0277] Figure 11 This is a perspective view of the upper portion 300 with a vial receiver 301. The vial receiver 301 includes a cup-shaped or funnel-shaped portion 302, to which a connector 303 is abutted. The connector 303 has at least one, particularly two, retaining rings 304 for engaging with the central portion 200. At least one retaining ring 304 is locked in place. Figure 8 It is located in the groove 208 of the connecting portion 203 of the middle part 200 shown in the figure.

[0278] The vial receiving section 301 also includes a plurality of clamping fingers 305 inclined along the insertion direction of the vial 90.

[0279] Preferably, to prevent the upper part 300 from rotating relative to the middle part 200, the upper part 300 may include, for example, at least one protrusion 306, which runs axially along the connector 303 and engages in a corresponding axial groove 208 in the middle part 200.

[0280] As in accordance with Figure 12 As shown in the top view, the width of the clamping fingers 305 tapers inward from the outer base. In the illustrated embodiment, the clamping fingers terminate within the tip 307. The outer bases of the clamping fingers 305 transition into each other through generally circular portions nested inside and out. Between the tips 307, the clamping fingers 305 are round, and particularly generally circular.

[0281] According to Figure 13 Along Figure 12As shown in the cross-sectional view of line AA, the clamping finger 305 is tilted at an angle α along the insertion direction. In the overview section of the instruction manual, this angle is referred to here relative to the underside of the clamping finger 305. The angle α at which the clamping finger 305 is tilted along the insertion direction of the vial 90 is specifically between 40° and 60°.

[0282] For example, specifically according to Figure 13 As can be seen in the perspective view, the thickness of the clamping finger 305 also gradually decreases, which is achieved by making the clamping finger 305 flatten towards the tip 307 on both its upper and lower sides.

[0283] The clamping finger 305 therefore grips the underside of the cap 91 or the head of the vial 90. Once the vial 90 is connected to the connector 60, the vial 90 cannot be pulled out of the connector 60 in a non-destructive manner.

[0284] Figure 14 This is a perspective view of cap 500, which serves as the original identification cover for connector 60.

[0285] The cap 500 includes an axially extending needle sleeve 501.

[0286] The needle sleeve 501 is connected to the annular insertion part 503 via the connecting strip 502.

[0287] In the installed state, the annular insertion part 503 is locked behind the step 308 of the upper part 300 (see...). Figure 18 ).

[0288] Therefore, the needle sleeve 501 can be removed from the insertion part 503 by breaking the needle sleeve 501 at the connecting bar 502.

[0289] refer to Figures 15 to 17 This explains an alternative implementation variation of the first embodiment of the invention, wherein the needle 401 is anti-rotation fixed, such that the connector 60 can be opened by the user but cannot be closed again.

[0290] Apart from the differences described below, this implementation variant essentially corresponds to the reference. Figures 1 to 14 The illustrated embodiment.

[0291] Figure 15 This is a perspective view of the central section, 200°.

[0292] Unlike the central section 200 shown in the previous illustration, this central section 200 has only a single window 202 through which the user can see that the connector 60 is open.

[0293] Figure 16 This is a top view of the lower part of section 200.

[0294] Unlike the embodiment shown above, multiple locking hooks 212 are arranged on the side wall of the middle section 200.

[0295] The middle section 200 also includes a stop 213, which, in the fully closed state... Figure 17 The stop 406a of the needle carrier 400 with needle 401 shown in the figure rests on the stop 213.

[0296] The first locking hook 212a serves as a stop for the middle 200 of the second stop 406b.

[0297] The needle carrier 400 also includes an elastic hook 417. When the needle 401 rotates on the sliding surface 418, the elastic hook 417 slides past the locking teeth 212, compresses behind each locking tooth 212, and thus cooperates with the locking teeth 212 to form an anti-rotation portion, which prevents the needle carrier 400 and the needle 401 from rotating back. Each time the elastic hook 417 engages with a locking tooth 212, the needle carrier 400 rotates further in a manner that prevents it from rotating back. Finally, the elastic hook 417 engages within the window 202 in a fully open state.

[0298] Here, the position of the open end can also be indicated by the hook 417 protruding into the window 202 and / or by the click sound that can be heard when the hook 417 is engaged in the window 202.

[0299] In the open position, the elastic hook 417 forms an anti-rotation part in the window 202. Due to the stop 406a of the needle carrier 400 resting on the first locking hook 212a and due to the anti-rotation part provided by the hook 417 snapping into the window 202, the needle carrier 400 cannot rotate in any direction in the open position of the connector 60.

[0300] Connector 60 is now on and can no longer be turned off.

[0301] Figure 18 yes Figures 1 to 14 The figure shows an axial cross-sectional view of connector 60 in its closed position.

[0302] The housing of connector 60 consists of a lower part 100, a middle part 200 and an upper part 300.

[0303] As described above, the sealing part 600 is clamped between the lower part 100 and the middle part 200, wherein the lower part 100 and the middle part 200 are interlocked.

[0304] The needle carrier 400 with disc 404 is located between the upper part 300 and the middle part 200, which includes the vial receiving part 301. In the configuration illustrated here, the passage 601 leading to the sealing part 600 of the passage 102 in the lower part is closed by disc 404, specifically by... Figure 6 The rotating disk 413 of the disk 404 shown is closed.

[0305] Therefore, the liquid cannot flow through the channel 412 of the needle 401 in the direction of the infusion bag 70 or flow in the opposite direction.

[0306] The user can now break the cap 500, or more precisely, the needle sheath 501 of the cap 500.

[0307] The cap 500 is locked behind the step 308 of the upper part 300 by the insertion part 503.

[0308] Figure 19 The connector 60 is shown in the axial sectional view after the cap 500 has broken and the needle 401 has rotated. The rotation of the needle 401 is specifically caused by the rotation of the connected vial 90 (not shown here). The needle 401 is rotated along with the vial because it is inserted into the septum of the vial 90 in a manner that prevents rotation.

[0309] The disc 404 of the needle carrier 400 is rotated by the rotation of the needle 401, so that the channel 411 with the opening 408 (see Figure 6 It overlaps with the channel 601 of the sealing part 600.

[0310] Liquid can now flow through the channel 412 of the needle 401, the channel of the seal 601, and the channel 102 of the lower part 100 into the infusion bag 70 or flow in the reverse direction. The fluid connection now extending through the connector 60 is indicated by the dashed arrow.

[0311] In this view, the channel 601 of the sealing part 600 is also visible, arranged radially offset relative to the rotation axis 415 of the needle 401.

[0312] The welded portion 101 is preferably located at the center of the rotation axis 415 of the needle. Obviously, the channel 102 that runs through the welded portion 101 can be laterally offset relative to the rotation axis 415.

[0313] By means of the orientation of the rotation axis 415 corresponding to the central axis (preferably corresponding to the central axis of the lower part 100, the middle part 200 and the upper part 300), a structure that is symmetrical when viewed from the outside is provided, wherein the torque generated when the needle 401 rotates is uniformly cut off by the two halves of the welded part 101.

[0314] However, due to the rotation of the disc 403, the liquid is laterally biased relative to the axis of rotation 415 and guided through the seal 600.

[0315] Reference Figures 20 to 29 It shows the relationship with Figures 1 to 14 In contrast, another embodiment of the present invention. The following explanation compares it to... Figures 1 to 14 The differences in the implementation methods shown.

[0316] Therefore, apart from the differences mentioned above, it can be compared with the reference. Figures 1 to 14 This implementation is designed in exactly the same way as shown.

[0317] therefore, Figure 20 This is a view of connector 60, which corresponds in its basic structural respects to Figures 1 to 14 The embodiment shown specifically includes a middle section 200 and a cap 500.

[0318] As in accordance with Figure 21 The detailed perspective view of the central section 200 is shown, which includes only a single window 201. The window 201 can be specifically designed as a surrounding slit (in part here).

[0319] Therefore, the indicator 407 is preferably not locked in its end position. The indicator 407 is preferably placed against the two ends of the window 201 in its end position.

[0320] and Figures 1 to 14 Compared to the embodiment shown, the advantage of this construction is that the indicator 407 can bounce back without having to overcome resistance.

[0321] On the other hand, in the embodiment illustrated here, the arrival at the destination can now be visually checked.

[0322] Figure 22 The perspective view shows the needle carrier 400 with the needle 401.

[0323] As in accordance with Figures 1 to 14 In one embodiment, the needle carrier 400 includes a disc 404 with an indicator 407.

[0324] The disc 404 also includes a ring 420 located on the side of the needle 401, which serves as a rotating disc within the housing.

[0325] The needle carrier 400 therefore includes a disc 404, which is mounted on both sides in the installed state.

[0326] The reinforcing rib 405 extends within the ring 420.

[0327] This facilitates a compact construction because the needle 401 does not need to protrude far from the disc 404.

[0328] The difference in this embodiment is that the needle 401 has a section with a thread 419. The thread 419 is a single-threaded thread and preferably includes fewer than two thread lines.

[0329] The leading edge of the thread 419 includes a tip 421. The tip 421 is provided by causing the tips of the thread teeth of the thread 419 to change direction, which is achieved by making the thread teeth arc-shaped or by making the teeth of the thread 419 have an ending portion facing the tip 412, in which the rise of the thread 419 increases. The tip 421 is specifically oriented at an angle of 0° to 70°, preferably 30° to 60°, relative to the central axis m of the needle 401.

[0330] When the needle 401 is inserted into the diaphragm, the tip 421 of the thread 419 is inserted into the diaphragm and the diaphragm is thus pulled onto the thread 419. If the vial is then rotated to open the connector, the thread 419 is first screwed into the diaphragm.

[0331] The rib 414 is adjacent to the thread 419 on the distal side as an anti-rotation part. In this area, the diameter of the needle 401 is increased due to the conical shape of the needle 401.

[0332] Upon reaching the rib 414, the needle 401 is then positioned within the diaphragm in a manner that prevents rotation, causing the disc 404 to rotate along with the rib as rotation continues, and the connector 60 to open, as referenced. Figures 1 to 14 As shown.

[0333] In this embodiment, the needle 401 includes a plurality of, particularly three, ribs 414 as anti-rotation portions, the ribs being arranged between the thread 419 and the distal end of the needle 401. In the open state of the connector, the diaphragm of the vial 90 is positioned in this area, i.e., sliding from the thread 414 into the area with the anti-rotation portions.

[0334] Rib 414 can taper radially. The resulting wedge shape makes it easier for the diaphragm to slide onto the part with the anti-rotation section.

[0335] As in accordance with Figure 23 As illustrated in the side view, disk 404 is rotatably supported on both sides, and includes a rotating disk 413 on one side and another rotating disk designed as a ring 420 on the other side.

[0336] The cut 403 of the needle 401 preferably terminates in front of the tip 421 of the thread 419, or, as illustrated herein, terminates at approximately the height of the tip 421 of the thread 419. This ensures that the needle 401 can only rotate when the diaphragm is in a sealing engagement with the needle 401. Torque, which may have already caused the needle 401 to rotate, can also be transmitted through the thread 414.

[0337] According to Figures 1 to 14 Another difference compared to the embodiment is the construction of the cap 500.

[0338] As in Figure 24 As illustrated in the perspective view, the needle cap 501 includes a gripping profile 504 to allow it to be better gripped and pulled down.

[0339] In this embodiment, the gripping profile 504 is provided by a large number of bumps.

[0340] The protrusions follow the axial orientation of the needle cap 501.

[0341] In this embodiment, the rows are arranged offset from each other. This ensures that the user always engages with the non-slip contour 504, regardless of where they grip the needle cap 501.

[0342] Figure 25 and Figure 26 Again, shown with supplementary markings Figure 20 Connector 60 is shown in the diagram. These markings indicate whether connector 60 is in its open (“open”) or closed (“closed”) state. These two markings are located on the sides of window 201. In addition, another marking (“rotate vial”) is added, which indicates to the user that connector 60 can be moved from one state to another by rotating vial 5.

[0343] Figure 27 and Figure 28 yes Figure 20 The figure shows a longitudinal cross-sectional view of connector 60 in its closed state.

[0344] Apart from the differences explained above, this construction corresponds to Figure 18 The structure in.

[0345] According to this embodiment, the housing of the connector 60 is formed by a lower portion 100, a middle portion 200, and an upper portion 300, wherein a sealing portion 600 is clamped between the lower portion 100 and the middle portion 200. The lower portion 100 and the middle portion 200 can interlock with each other.

[0346] The needle carrier 400 with disc 404 is located between the upper part 300 and the middle part 200, which includes the vial receiving part 301.

[0347] The channel 601 of the sealing part 600—which leads to the channel 102 of the lower part 100—is closed by the disk 404. For example, in Figure 28 As shown, the channel 411, which extends laterally to the channel 412, does not overlap with the channel 601 of the sealing part 600.

[0348] Connector 60 enters the open state, except for the screwing in of thread 419, corresponding to Figure 19 The illustration.

[0349] Figure 29This is a side view of another embodiment of connector 60.

[0350] This connector 60, except for the differences explained below, essentially corresponds to the implementation described above, that is, except for the differences, the connector 60 can therefore have all the features described above except for the differences.

[0351] Specifically, this embodiment also includes an upper portion 300, a middle portion 200, and a lower portion 100. Window 201 corresponds to the embodiment described above.

[0352] In this embodiment, as discussed above, the indicator 407 rotates to both end positions of the window 201, and preferably does not lock within a single window in its end positions. This variation facilitates easy opening and closing of the connector 60.

[0353] The open position is shown in the figure. Therefore, indicator 407 is located at the "open" position.

[0354] Figure 30 This is a side view of connector 60 viewed from different directions.

[0355] Figure 31 It is along Figure 29 The cross-sectional view taken by section line AA.

[0356] As in the aforementioned embodiment, the sealing portion 600 is clamped between the middle portion 200 and the upper portion 300.

[0357] The structure of the middle part 200, the upper part 300 and the sealing part 600 can be the same as in the aforementioned embodiment.

[0358] Figure 32 It is along Figure 30 The cross-sectional view taken by section line BB.

[0359] In this embodiment, the opening of the connector and the fluid channel formed therein also correspond to Figure 19 The illustration in the image is provided. Therefore, you can refer to it. Figure 19 .

[0360] In particular, the opening 408 of the channel 411, which slopes into the channel 412 of the needle 401, overlaps with the channel 601 of the sealing portion 600 to provide fluid connection.

[0361] This is achieved, according to the preceding embodiment, by rotating the needle carrier 400 with the needle 401. The fluid connection is indicated by dashed lines.

[0362] Figure 33 This is a perspective view of a needle carrier 400 with a needle 401. According to... Figures 1 to 14In the embodiment shown, the needle 401 does not include threads that screw into the diaphragm of the vial 90. Unlike the embodiment illustrated above, the tip 402 of the needle 401 is provided with a reinforcing portion 422.

[0363] Within the region of the tip 402, the wall of the needle 401 is widened radially outward, such that the tip 402 is arranged on a thickened wall that is laterally offset.

[0364] Below the opening of the channel 412 of the needle 401, the thickness of this radially outward-pointing reinforcement 422 decreases.

[0365] Within the portion 423 located between the rib 414, which functions as an anti-rotation part, and the reinforcement 422, the needle 401 preferably transitions into a circular outer contour, thereby ensuring optimal sealing before the needle carrier 400, together with the needle 401, can be rotated through the vial 90 to open the fluid connection.

[0366] In this embodiment, a sufficiently stable needle 401 can be provided in a simple manner, making the needle 401 easy to insert, having a good sealing effect, and simultaneously cooperating with the sealing part 600 to provide an anti-rotation part 90 so that the vial 90 can be used as an actuator for the needle carrier 400 together with the needle 401.

[0367] The construction of indicator 407 corresponds to that according to Figure 22 The illustration is shown with reference to its overall description. Indicator 407 is specifically arranged flexibly in the radial direction.

[0368] Figure 34 This is a side view of the needle carrier 400 with the needle 401.

[0369] Figure 35 It is along Figure 34 The cross-sectional view taken from the section line CC, i.e., the central longitudinal section.

[0370] The wall thickness of the needle 401 is increased in the area of ​​the reinforcing part 422.

[0371] Specifically, the wall thickness d in the region where the reinforcing part 422 is at its thickest position max At least the wall thickness d of the needle 401 at its thinnest point min It is 1.5 times, preferably at least 1.8 times.

[0372] The reinforcement section 422 gradually terminates along the proximal direction.

[0373] Before the tapered portion of the rib 414 connects to the needle 401, the needle 401 has a circular outer contour at approximately the middle.

[0374] In this embodiment of the invention, the disk 404 is also supported on both sides, namely on the distal side by a ring 420 and on the proximal side by a rotating disk 413.

[0375] As in accordance with Figure 36 As shown in the top view of the needle 401, the tip 402 of the needle 401 together with the needle carrier 400, and the ring 420 is connected to the needle 401 by a reinforcing rib 405.

[0376] The reinforcing part 422 may extend around the periphery of the needle 401 at an angle β of less than 90°, preferably less than 60° and / or greater than 20°, preferably greater than 30°.

[0377] Figure 37 This is a flowchart illustrating an embodiment of the method according to the present invention, which is applicable to all implementations of medical packaging, particularly... Figures 1 to 36 The infusion bag 70 and / or shown in the figure Figure 11 'to Figure 19 The infusion bag 1 shown in the figure can be used.

[0378] First, insert the vial into the vial receiver of the connector. Due to the clamping fingers of the vial receiver, the vial is now inseparably connected to the connector. The needle punctures the septum of the vial upon insertion. This inseparable connection prevents accidental loosening of the vial. In particular, it prevents leakage of contents from the vial and / or infusion bag due to the vial becoming loose.

[0379] The user then rotates the vial to the end position. The septum of the vial causes the needle to rotate with it, thus opening the fluid connection between the medical packaging, particularly the vial and the infusion bag. Preferably, the user is indicated to the opened end position by an audible and / or perceptible latch.

[0380] The liquid in the vial can now flow into the medical packaging, such as into an infusion bag, or if the vial contains solids, the liquid can first flow from the medical packaging into the vial so that the solids can dissolve in the liquid.

[0381] According to an embodiment of the invention, the user can then turn the vial back in the opposite direction, causing the connector to close again. This prevents liquid from potentially flowing back into the emptied vial.

[0382] In another embodiment of the invention, the connector is locked in the open end position, so that the connector can no longer be closed.

[0383] Finally, the user removes the cap from the outlet and attaches a medical package, such as an infusion bag, to the transfer system to administer the medical fluid.

[0384] The use of the connector according to the invention enables simple and safe dosing of substances contained in vials.

[0385] Figure 1 'to Figure 19 The second embodiment of the invention is shown, wherein the needle 10 has a side opening 33 and moves axially by rotational motion.

[0386] Figure 1 This is an illustration of a medical package designed as an infusion bag 1, with a vial 5 to be attached to the infusion bag 1.

[0387] The infusion bag 1 is made of a thin film welded together by welds 7 and 8. The infusion bag 1 has a suspension part 9 for attaching the infusion bag 1 to a support.

[0388] The infusion bag 1 also includes at least one dispensing port 4.

[0389] The liquid extraction port 4 is made of a lower part 4a welded into the weld 7 of the bag 1 and an upper part 4b having a broken portion 4c. In addition, the liquid extraction port 4 also includes a diaphragm (not shown) preferably clamped and fixed between the lower part 4a and the upper part 4b.

[0390] After the broken portion 4c is broken off, the diaphragm of the fluid extraction port 4 can be punctured, for example, using the needle of a transfer device, to extract the infusion fluid and deliver it to the patient.

[0391] The infusion bag 1 also includes a port 2, which is designed as a connector 3 through which a fluid connection to the vial 5 can be established. The connector 3 includes a lower portion 3a, which in this embodiment is welded into region 6 of the weld 7. Further details regarding the connector 3 will be explained with reference to the following figures.

[0392] Connector 3 provides another inlet or port 2 through which liquid can be transferred from vial 5 to infusion bag 1. Liquid can also be transferred from infusion bag 1 to vial 5, for example, to dissolve solid, such as powdered, active ingredients present in vial 5, and then the resulting solution is transferred back to infusion bag 1.

[0393] Bottle 5 includes a cap 12, which is specifically designed as a rolled-edge metal cap or as a latching cap, and this cap 12 includes a diaphragm 52 (see...). Figure 19 The diaphragm 52 can be punctured by the needle 10 of the connector 3.

[0394] In this embodiment, in order to connect the vial 5 to the infusion bag 1, the sealing film 11 is first removed from the connector 3. It goes without saying that a cap or a combination of a sealing film and a cap (not shown) can also be provided as an alternative to the sealing film 11.

[0395] Then, the vial 5 and the cap 12 are first pushed forward into the connector 3, wherein the funnel-shaped or especially cup-shaped construction of the connector 3 simplifies the introduction of the center.

[0396] The diaphragm 52 of vial 5 is pierced by needle 10 and is locked in place by the cap 12 or head of vial 5, which is designed to be a snap ring, within connector 3 (see...). Figure 18 a' and Figure 18 b').

[0397] The fluid connection between the vial 5 and the infusion bag 1 can then be established by rotating the vial 5—rotating the vial 5 along with the needle 10. For this purpose, the connector 3 includes a valve, which is preferably operable by rotational movement.

[0398] Figure 2 This is a perspective view of connector 3 only (without infusion bag 1), with vial 5 connected to connector 3. Vial 5 is locked inside cup-shaped or funnel-shaped vial receiving part 14.

[0399] In this embodiment, the lower portion 3a of the connector 3 includes a connection portion for the infusion bag 1, which is specifically designed as a soldered portion 18. In this embodiment, the soldered portion 18 is designed in a boat shape. The channel 17 extends into the infusion bag 1 through the lower portion 3a of the connector 3.

[0400] The lower part 3a is connected to the middle part 13, which in turn is connected to the vial receiving part 14. In another embodiment not shown, the middle part 13 and the vial receiving part 14 may also be designed as a single unit.

[0401] Furthermore, according to another embodiment, the lower portion 3a of connector 3 may also have a connector for soldering onto the port as an alternative to a connection portion for soldering into the infusion bag 1. In this embodiment, not shown here, the connector is designed as a separate adapter for the port. The connector 3's connector may, for example, be designed as a Luer connector or a Luer lock connector.

[0402] Figure 3 This is a side view of connector 3, whose housing consists of a lower part 3, a middle part 13, and a vial receiving part 14. Therefore, in this embodiment, the housing of connector 3 is designed as a three-part structure.

[0403] The connecting part 19 is located between the lower part 3a and the middle part 13 of the connector 3. The connecting part 15 is located between the middle part 13 and the vial receiving part 14.

[0404] The three housing components are specifically designed to interlock with each other, as explained in detail below.

[0405] The connecting portion 15 between the middle portion 13 and the vial receiving portion 14 has a larger diameter than the connecting portion 19 between the lower portion 3a and the middle portion 13, because the connecting portion 15 matches the larger vial receiving portion 14.

[0406] The needle 10 is disposed inside the housing. The needle 10 is designed as a hollow needle, preferably made of plastic, and protrudes into the vial receiving portion 14, which is designed as a partial funnel or cup.

[0407] In this embodiment, the vial receiving portion 14 includes a notch 16 on the edge side. The notch 16 allows the user to see the entire internal volume of the (transparent) vial 5. In this way, the user can, for example, check whether the vial 5 has been completely emptied or whether the active ingredient has been completely dissolved.

[0408] Figure 4 This is an exploded perspective view of the components of connector 3. In this embodiment, the components of connector 3 include a lower part 3a, a needle 10, a sealing element 21, a middle part 13, and a vial receiving part 14.

[0409] The lower part 3a of the connector 3 with channel 17 includes a solder portion 18 and a connecting portion 19 on the opposite side of the lower part 3a leading to the middle part 13.

[0410] In the installed state, the connecting part 19 of the lower part 3a locks with the head part 20 of the middle part 13.

[0411] A sealing element 21 with a channel 25 for the needle 10 is inserted between the lower part 3a and the middle part 13. The sealing element 21 can be used to seal the infusion bag 1 or cooperate with the needle 10 as a valve component.

[0412] The needle 10 includes a thread 23, which, in the installed state, is located within the thread 28 of the lower portion 3a (see also...). Figure 6 The thread 23 of the needle 10 is preferably designed as an external thread, while the thread 28 of the lower part 3a is designed as an internal thread.

[0413] The connecting portion 15 of the middle section 13 is itself locked onto the connecting portion 24 of the vial receiving section 14. As discussed above, in embodiments not illustrated here, the middle section 13 and the vial receiving section 14 may also be designed as a single unit.

[0414] Figure 5 'This is a perspective view of the lower part 3a, which has a connecting portion 19 and a welded portion 18 with the middle part 13. Figure 6 'This is the axial section view of the lower part 3a, and Figure 7 'This is a top view of the lower part 3a (viewed from the infusion bag 1).

[0415] As in accordance with Figure 6 As shown in the longitudinal cross-sectional view, the connecting portion 19 includes a retaining ring 26, which is locked in a corresponding groove 39 in the middle portion 13 (see...). Figure 14 ').

[0416] The connecting portion 19 also includes teeth 27, which engage in the installed state with teeth 36 of the middle portion 13 (see also) Figure 14 '), and forms an anti-rotation part.

[0417] The end portion 40 of the lower part 3a is engaged into the sealing element 21 in the installed state of the lower part 3a. The end portion 40 of the lower part 3c rests against the upper side of the sealing element 21 next to the ring 34 of the sealing element 21.

[0418] The thread 28 in the lower 3a, especially as in Figure 7 The thread 28 shown in the figure is designed as a segmented thread. In this embodiment, the thread 28 includes five segments.

[0419] Therefore, axially extending cavities 50 are provided between the segments of the thread 28, and in the open state of the connector 3, the cavities 50 cooperate with the needle 10 to form at least one axially extending channel for the passage of liquid.

[0420] Figure 8 The left side shows a first side view of the needle 10, the middle shows a second side view of the needle 10 rotated 90°, and the right side also shows a perspective view of the needle 10. In one embodiment, the needle 10 is made of plastic, such as polycarbonate. The needle 10 includes an insertion portion 29. The insertion portion 29 has a tip 30.

[0421] The lateral incision 22 extends from the tip 30 into the side wall of the needle 10 and terminates within the insertion portion 29. On the one hand, this facilitates the piercing of the septum of the vial 5; on the other hand, it provides a large cross-section for the passage of liquid.

[0422] Between the thread 23 and the insertion portion 29, the needle 10 includes a side opening 33 for liquid passage. The side opening 33 is sealed by the sealing element 21 in both the installed and closed states of the connector 3 (see...). Figure 18 a' and 18b').

[0423] Here, the needle 10 includes a double-threaded thread 23, which in this embodiment has a gap 49 in a flat portion designed as thread teeth. These gaps 49 are arranged axially in succession.

[0424] In the open state of connector 3, the gap 49 at least partially overlaps with the gap 50 of the thread 28 of the lower part 3a, thereby forming at least one axially extending channel for the passage of liquid.

[0425] Figure 9 This is an axial cross-sectional view of the needle 10. The needle 10 is designed at least partially as a hollow needle.

[0426] The insertion portion 29 of the needle 10 includes an axially extending channel 31, which transitions laterally, preferably radially, into a channel 32 within the central region of the needle 10, forming a side opening 33. The axially extending channel 31 and the radially extending channel 32 together form a channel or passage for transferring liquid from the vial 5 into the infusion bag 1 or from the infusion bag 1 into the vial 5.

[0427] As in accordance with Figure 10 As shown in the top view of the tip 30 of the needle 10, the insertion portion 29 of the needle 10 is at least partially not circular. The insertion portion 29 of the needle 10 is preferably at least partially shaped as a polygon, particularly a trapezoid. This provides an anti-rotation portion when the needle 10 pierces into the septum of the vial 5.

[0428] Figure 11 This is a perspective view of a sealing element 21 constructed of an elastic material. The sealing element 21 includes a central passage 25, the sidewalls 48 of which surround the needle 10 in a sealing manner in the installed state. In the closed state, the sidewalls 48 also seal the side openings 33 of the needle 10.

[0429] In this embodiment, the sealing element 21 includes radial ribs 47 on its upper side and / or lower side (not shown in the figure), which can also serve as an anti-rotation part. However, since the sealing element 21 is securely clamped between the lower part 3a and the middle part 13, the ribs 47 can be omitted if necessary.

[0430] As in accordance with Figure 12 As illustrated in the cross-sectional view, the sealing element 21 includes a ring 34 on the edge side, which forms a 90° rotated, surrounding T-shaped portion of the sealing element 21. In the installed state, this ring 34 is fixed on one side in a shaped-face engagement within an annular groove 37 on the end side of the central portion 13 (see [reference needed]). Figure 14 On the opposite side, a ring 34 is fixed between the end portion 40 of the lower portion 3a and the head member 20 of the middle portion 13, which engage within the sealing element 21, such that there is a form fit on both sides of the sealing element 21. The inner flange 35 of the sealing element 21, extending in the direction of the central portion 13, engages within the annular portion 38 of the central portion 13 (see also...). Figure 14 'as well as Figure 18 'and Figure 19 ').

[0431] In this way, the sealing element 21 is securely fixed between the lower part 3a and the middle part 13 without the risk of being pushed out.

[0432] Figure 13 ' is a perspective view of the middle part 13, which includes a connecting part 15 for the vial receiving part 14 and a head part 20 for insertion into the lower part 3a. Figure 14 'This is the cross-sectional view of the middle section 13.

[0433] The head component 20 is designed as a connecting portion 41 for insertion into the connecting portion 19 of the lower portion 3a. For this purpose, the head component 20 includes a groove 39 in which the retaining ring 26 of the lower portion 3a is locked in the installed state (see also...). Figure 6 'and Figure 18 a' / b' and Figure 19 The head component 20 has teeth 36 on the inner side of the lower part of the radial groove 39, and the retaining ring 26 of the lower part 3a is locked in the groove. In the installed state, the sealing element 21 is located in the area of ​​the teeth.

[0434] On the one hand, the teeth 36 serve as an anti-rotation part for the sealing element 21, which is pressed and thus pressed into the teeth 36.

[0435] On the other hand, at the radial groove 39 where the retaining ring 26 adjacent to the lower part 3a is locked, the tooth 27 of the lower part 3a engages with the tooth 36 of the middle part 13, so that the lower part 3a is also fixed relative to the middle part 13 to prevent rotation through the tooth 36 of the middle part 13.

[0436] As described above, the annular groove 37 on the end side serves as a form-fitting element for the surrounding ring 34 of the sealing element 21. The flange 35 of the sealing element 21 engages within the inner annular portion 38 of the center 13.

[0437] In this embodiment, the connecting portion 15 includes two surrounding grooves 42, and the retaining rings 43 of the vial receiving portion 14 are respectively locked into the grooves 42 (see...). Figure 15 ').

[0438] Figure 15 This is a perspective view of the vial receiving section 14. The vial receiving section 14 includes a cup-shaped or funnel-shaped portion 44 with a connecting member 51 abutting the vial receiving section 14, which has two retaining rings 43 for the middle portion 13.

[0439] The vial receiving section 14 also includes a plurality of clamping fingers 45 that are inclined along the insertion direction of the vial 5.

[0440] As in accordance with Figure 16As illustrated in the top view, the width of the clamping fingers 45 tapers inward from the outer base. In the illustrated embodiment, the clamping fingers 45 terminate internally at a tip 46. The outer bases of the clamping fingers 45 transition into generally rounded portions. Between the tips 46, the clamping fingers 45 are rounded, particularly substantially rounded.

[0441] As in Figure 17 As illustrated in the cross-sectional view, the clamping finger 45 is tilted at an angle α along the insertion direction. The degree mentioned in the invention description is relative to the underside of the clamping finger 45. The angle at which the clamping finger 45 is tilted along the insertion direction of the vial 5 is specifically between 40° and 60°.

[0442] Especially according to Figure 15 As can be seen in the perspective view, the thickness of the clamping finger 45 also gradually decreases, which is achieved by making the clamping finger 45 flatten towards its tip 46 on its upper and lower sides.

[0443] The clamping finger 45 thus grips the underside of the cap 12 or the head of the vial. Once the vial 5 is connected to the connector 3, it cannot be pulled out of the connector 3 in a non-destructive manner.

[0444] Figure 18 a' and 18b' show longitudinal cross-sectional views of the entire connector 3 in the closed state of fluid connection. Figure 18 a' shows connector 3 without vial 5. And... Figure 18 b' shows the connector 3 connected to the vial 5. The vial 5 is locked to the connector 3. In the connected state, the needle 10 of the connector 3 penetrates the diaphragm 52 inside the vial 5.

[0445] The needle 10 can be moved to the open and closed end positions 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.

[0446] 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.

[0447] As mentioned above, Figure 18 a' and Figure 18 b' shows the closed end position of the needle 10. In this closed position, the side opening 33 formed by the radial channel 32 extending from the axial channel 31 of the needle 10 is closed by the sealing element 21. At the same time, the sealing element 21, inserted between the lower part 3a and the middle part 13, seals the infusion bag 1 relative to the outside.

[0448] Figure 19The cross-sectional view shows a vial 5 inserted into connector 3, with connector 3 now in its open state. A needle 10 pierces the septum 52 of vial 5. By rotating vial 5, needle 10 is positioned at the open end of connector 3.

[0449] By rotating the vial 5, the needle 10, which is locked within the septum 52 of the vial 5 in a rotation-preventing manner, rotates along with it. The needle 10 thus rotates to the open end position. Because of the rotation of the needle 10, the thread 23 of the needle 10 rotates in the thread 28 of the lower part 4a. Therefore, the needle 10 moves axially, causing the radial channel 32 and thus the side opening 33 to move away from the sealing element 21.

[0450] Fluid can now flow into the infusion bag 1 through the channel 17 in the lower part 3a via the side opening 33 on the thread 23 of the needle 10, or flow in the opposite direction.

[0451] As described above, the segmented thread 28 in the lower part 3a cooperates with the gap 49 in the thread 23 of the needle 10 to allow flow along the axial channel extending from the side opening 33 to the channel 17. The liquid thus flows axially along the thread 23 of the needle 10 after exiting the side opening 33 in the lower part 3c.

[0452] In the open position, the needle 10 is preferably resting against the end position. Preferably, the fluid connection can also be closed again by turning the vial 5 back until the needle 10 is resting against the end position. Figure 18 This is achieved at the end position shown in the diagram b'.

[0453] The present invention provides a simple, easy-to-operate, and safe connector 3 for vial 5, for example, for connecting vial 5 to infusion bag 1.

[0454] List of reference numerals

[0455] 1. Infusion bag

[0456] 2 ports

[0457] 3 Connectors

[0458] 3a Lower part of connector 3

[0459] 4. Liquid dispensing port

[0460] 4a Lower part of liquid collection port 4

[0461] 4b Upper part of the liquid dispensing port

[0462] 4c Broken part of the liquid dispensing port

[0463] 5 small bottles

[0464] 6. Area of ​​transverse weld 7

[0465] 7. Transverse weld

[0466] 8. Longitudinal welds

[0467] 9. Suspension section

[0468] 10 needles

[0469] 11 Sealing film of connector 3

[0470] 12 small bottles with 5 caps

[0471] 13. Middle part of connector 3

[0472] 14. Bottle receiving part of connector 3

[0473] 15 The connecting part of the middle section 13 for the vial receiving section 14

[0474] 16. Empty space inside the small bottle receiving section 14

[0475] 17. Channel within the lower part 3a of connector 3

[0476] 18. Soldering portion of the lower part 3a of connector 3

[0477] 19. Connection portion with the lower part 3a of connector 3

[0478] 20 The head component of the middle part 13 of connector 3

[0479] 21 Sealing element of connector 3

[0480] 22. Incision within 10mm of the needle.

[0481] 23. Thread of needle 10

[0482] 24. Connection part of small bottle receiving section 14

[0483] 25. Passage within the sealing element 21 of connector 3

[0484] 26. The retaining ring on the lower part 3a of connector 3

[0485] 27 The teeth of the lower part 3a

[0486] 28. Thread inside the lower part 3a

[0487] 29. Insertion portion of needle 10

[0488] 30 needle tip 10

[0489] 31 Axial channel within the needle 10

[0490] 32 Radial channels within the needle 10

[0491] 33. The needle has an inner opening of 10.

[0492] 34. Ring of sealing element 21

[0493] 35. Flange of sealing element 21

[0494] 36. Teeth in the middle 13.

[0495] 37. Groove on the end side within the middle 13

[0496] 38 The inner ring section within the middle 13

[0497] 39 Radial groove in the middle 13

[0498] 40 Lower part 3a end side end

[0499] 41 The connection between the middle part 13 and the lower part 3a

[0500] 42 The groove in the middle 13

[0501] 43. The retaining ring of the small bottle receiving section 4

[0502] 44. The funnel-shaped or cup-shaped part of the vial receiving section

[0503] 45. Clamping fingers of the vial receiving section 14

[0504] 46. ​​Clamp the tip of finger 45.

[0505] 47 Ribs on the ring 34 of sealing element 21

[0506] 48 Sidewall of passage 25 within sealing element 21

[0507] 49. The notch (or flat portion) of the thread 23 of the needle 10.

[0508] 50 The gap in thread 28 within the lower 13a

[0509] 51 The connecting part between the small bottle receiving section 14 and the middle section 13

[0510] 52 small bottles of 5 diaphragm

[0511] 60 connector

[0512] 70 IV bags

[0513] 71 Transverse weld

[0514] 72 Longitudinal weld

[0515] 73 Suspension section

[0516] 74. Area of ​​transverse weld

[0517] 80 Liquid dispensing port

[0518] 81 lower part

[0519] 82 upper

[0520] 83. Folded section

[0521] 90 small bottles

[0522] 91 small bottle with 90 cap

[0523] 100 lower

[0524] 101 Welded Part

[0525] Channel 102

[0526] 103 boards

[0527] 104 Ribs for engaging with the sealing part 600

[0528] 105 ribs for locking into the lower annular groove

[0529] 106 Ring for engagement with the transition region 607 of the seal

[0530] Channel 107

[0531] 200 Central

[0532] Window 201

[0533] Window 202

[0534] 203 Connection part for upper part 300

[0535] 204 Connecting part for lower part 100

[0536] 205 Sealing section receiving section

[0537] 206 vacancies

[0538] 207 Stop

[0539] 208 Slot for the upper part 200 of the lock

[0540] 209 Slot for the lower part 100 of the lock

[0541] 210 Annular groove (for sealing part 600)

[0542] 211 Receiving section for rotating disk 413

[0543] 212 Locking teeth

[0544] 212a First Lock Hook

[0545] 213 Stop

[0546] 300 upper

[0547] 301 Bottle Receiving Section

[0548] 302 Cup-shaped or funnel-shaped receiving part

[0549] 303 Connector

[0550] 304 Card Circle

[0551] 305 Clamping fingers

[0552] 306 Protruding Rib

[0553] 307 tip

[0554] 308 steps

[0555] 400 Needle carriers with needles

[0556] 401 needle

[0557] 402 tip

[0558] 403 incision

[0559] 404 disk

[0560] 405 reinforced edge

[0561] 406 Stop

[0562] 406a stop

[0563] 406b stop

[0564] 407 indicator

[0565] 407a recess

[0566] 408 Opening

[0567] 409 Spring

[0568] 410 Bow-shaped section

[0569] Channel 411

[0570] 412 Channel of needle 401

[0571] 413 Rotary Disk

[0572] 414 Rib (Anti-rotation part)

[0573] 415 Rotation axis

[0574] 416 Excavated Area

[0575] 417 Flexible Hook

[0576] 418 Sliding Surface

[0577] 419 thread

[0578] 420 rings

[0579] 421 The tip of thread 419

[0580] 422 Reinforcement section of tip 402

[0581] 423 The section between the reinforcing part and the anti-rotation part

[0582] 500 hats

[0583] 501 Needle Sheath

[0584] 502 connecting strip

[0585] 503 Insertion Section

[0586] 504 Grip Outline

[0587] 600 Sealing Part

[0588] Channel 601

[0589] 602 is used for the support surface of 604.

[0590] 603 Annular Groove

[0591] 604 Ribs or Flanges

[0592] 605 Ribs or flanges

[0593] 606 is used for the receiving area of ​​the lower part 100.

[0594] 607 Transition Zone

Claims

1. A medical package designed as an infusion bag (70), the medical package including a connector (60) for connecting a vial (90). in, The connector (60) includes a needle (401) for piercing the diaphragm (52) of the vial (90) to provide fluid connection to the internal volume of the infusion bag (70). The needle (401) is designed to rotate within the connector (60) to establish a fluid connection from the vial (90) to the internal volume of the infusion bag (70). The needle (401) is arranged on a needle carrier (400) including a disc (404), wherein the disc (404) is rotatably arranged in front of a sealing part (600), wherein the sealing part (600) includes a channel (601), wherein the channel (601) of the sealing part (600) can overlap with an opening (408) on the disc (404) by the rotational movement of the disc (404). The opening (408) on the disc (404) transitions into the needle (401) through a channel (411) extending transversely to the channel (412) of the needle (401). The fluid connection is achieved by rotational motion causing the opening (408) of the laterally extending channel (411) connected to the needle (401) to overlap with the channel (601) within the sealing portion (600) of the connector (60). The opening (408) of the laterally extending channel (411) connected to the needle (401) is arranged radially offset relative to the axis of rotation of the needle (401).

2. The medical packaging designed as an infusion bag according to claim 1, characterized in that, The sealing part (600) includes an axial channel (601).

3. The medical packaging designed as an infusion bag according to claim 1, characterized in that, The disc (404) is rotatably arranged between the upper (300) and middle (200) portions of the connector (60).

4. The medical packaging designed as an infusion bag according to claim 3, characterized in that, The upper part (300) and the middle part (200) are interlocked.

5. The medical packaging designed as an infusion bag according to any one of claims 1 to 4, characterized in that, The sealing part (600) is arranged between the lower part (100) and the middle part (200) of the connector (60).

6. The medical packaging designed as an infusion bag according to claim 5, characterized in that, The lower part (100) and the middle part (200) are interlocked.

7. The medical packaging designed as an infusion bag according to any one of claims 1 to 4, characterized in that, The needle (401) and the disc (404) are designed as a single piece of plastic.

8. The medical packaging designed as an infusion bag according to any one of claims 1 to 4, characterized in that, The connector has an original label cover, which includes a removable cap (500) covering the needle (401).

9. The medical packaging designed as an infusion bag according to claim 8, characterized in that, The cap (500) includes an insertion portion (503) from which the needle sheath can be broken off.

10. The medical packaging designed as an infusion bag according to claim 9, characterized in that, The cap is fixed inside the upper part (300) of the connector (60) by the insertion part (503).

11. The medical packaging designed as an infusion bag according to any one of claims 1 to 4, characterized in that, The needle (401) includes threads (419) extending on a sub-part of the needle (401).

12. The medical packaging designed as an infusion bag according to claim 11, characterized in that, In another sub-section between the thread (419) and the needle carrier (400), the needle (401) includes an anti-rotation portion.

13. The medical packaging designed as an infusion bag according to claim 12, characterized in that, The anti-rotation part is designed as at least one rib (414).

14. The medical packaging designed as an infusion bag according to claim 1, characterized in that, The tip (402) of the needle (401) is arranged on the reinforcement (422).

15. The medical packaging designed as an infusion bag according to claim 14, characterized in that, The tip (402) of the needle (401) is arranged on a reinforcement (422) formed by a thickened wall portion extending in the radial direction.

16. The medical packaging designed as an infusion bag according to any one of claims 1 to 4, characterized in that, The connector (60) is designed to enable the needle (401) to move more than one-eighth of a turn and / or less than one full turn from the closed position to the open position.

17. The medical packaging designed as an infusion bag according to any one of claims 1 to 4, characterized in that, The connector (60) is designed to allow the needle (401) to move approximately one-quarter of a turn from the closed position to the open position.

18. The medical packaging designed as an infusion bag according to any one of claims 1 to 4, characterized in that, The connector (60) includes an indicator (407) that indicates whether the connector (60) is open or closed.

19. The medical packaging designed as an infusion bag according to claim 18, characterized in that, The connector (60) includes at least one side window (201, 202) through which the indicator (407) can be seen in the open or closed position of the connector (60).

20. The medical packaging designed as an infusion bag according to claim 19, characterized in that, The indicator (407) is arranged on a spring (409) that engages the indicator (407) into the window (201, 202) in the open and / or closed state of the connector (60).

21. The medical packaging designed as an infusion bag according to claim 14, characterized in that, The needle (10) includes a channel with a side incision (403).

22. The medical packaging designed as an infusion bag according to claim 21, characterized in that, The side cut (403) is opposite to the tip (402).

23. The medical packaging designed as an infusion bag according to any one of claims 1 to 4, characterized in that, The connector includes a vial receiver with multiple clamping fingers that are inclined inward along the insertion direction of the vial.

24. The medical packaging designed as an infusion bag according to claim 23, characterized in that, The vial receiving section has a funnel-shaped portion for introducing the vial.

25. A connector (60) for providing a fluid connection between a medical package (70) according to any one of the preceding claims and a vial (90), wherein the connector (60) includes a needle (401) for piercing a septum of the vial (90). Its features are, The needle (401) is arranged on a needle carrier (400) including a disc, wherein the disc (404) is rotatably arranged in front of the sealing portion (600), wherein the sealing portion (600) includes an axial channel (601), wherein the axial channel (601) of the sealing portion (600) can overlap with an opening (408) on the disc (404) by the rotational movement of the disc (404), and thus open the fluid connection between the vial (90) and the medical package (70), wherein the opening (408) transitions into the needle (401) through a channel (411) extending transversely to the channel (412) of the needle (401).

26. The connector (60) according to claim 25, characterized in that, The connector (60) is designed as an adapter capable of connecting to the port of the medical packaging (70).

27. The connector (60) according to claim 26, characterized in that, The adapter is an adapter that can be connected to the port of the medical package in a Luer connection or a Luer lock connection manner.

28. The connector (60) according to claim 25, characterized in that, The connector (60) is a component of the port of the medical packaging.

29. A method for providing a fluid connection between a connector (60) comprising a needle (401) and a first medical package (90) and a second medical package, according to any one of claims 25 to 28. in, The first medical package (90) is pushed onto the connector (60) of the second medical package, such that the needle (401) pierces the diaphragm (52) of the first medical package (90) to provide a fluid connection to the internal volume of the second medical package. The needle (401) is arranged on a needle carrier (400) comprising a disc (404) rotatably arranged in front of the seal (600), wherein the seal (600) includes a channel (601) extending through the seal (600), wherein the needle (401) is rotated about the central axis of the needle by rotational movement of the first medical package (90) and / or the connector (60), and thus opens the fluid connection from the first medical package (90) to the second medical package by the channel (601) of the seal (600) overlapping an opening (408) on the disc (404) by rotational movement of the disc (404).

30. The method according to claim 29, characterized in that, The first medical packaging (90) is designed as a vial (90).

31. The method according to claim 29, characterized in that, The second medical packaging was designed as an infusion bag (70).

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