Sterile connector

Abstract

The present invention relates to sterile connectors for the sterile connection of a first closed system to a second closed system, to a method for the sterile connection of a first closed system to a second closed system, to a method for the sterile transfer of biologically active liquids, and to devices for the sterile connection of a first closed system to a second closed system.

Description

[0001] DESCRIPTION

[0002] Sterile connector

[0003] The present invention relates to sterile connectors for sterilely connecting a first closed system to a second closed system, methods for sterilely connecting a first closed system to a second closed system, methods for sterilely transferring biologically active media and devices for sterilely connecting a first closed system to a second closed system.

[0004] In many areas of pharmaceutical and bioproduction, it is necessary to transfer liquid and gaseous media between two process steps from a first closed system, in particular a first container, to a second closed system, in particular a second container. In this case, it must be ensured that the transfer, i.e. transport, of the medium to be transported is carried out aseptically and free of contamination. At all times during the transfer, it must be prevented that contamination, for example unwanted materials, in particular foreign bodies such as bacteria, enters the medium during the transfer and contaminates it. The media to be transported are usually endowed with desired chemical and / or biological activities, for example enzymatic, catalytic or cell-bound activities, and are therefore often thermo- or UV-sensitive.

[0005] To transfer the medium from a first closed system to a second closed system, a fluid connection must be established between the two systems. For this, the two closed systems must be opened. Due to the risk of contamination, this opening represents a critical process step that places high technical demands on the connection system, especially a sterile connector.

[0006] A known method for connecting two closed systems is hose welding. This involves placing two hoses in a device that welds them together, thus creating a material-tight connection between the two systems. A disadvantage is that welding requires the hoses to be made of specific materials. Furthermore, these devices can only weld hoses of certain diameters together. Due to the material-tight connection, reusing the hoses is extremely costly.

[0007] In addition to the described material-locking connection, various methods are known for creating force- and form-locking connections between two closed systems. These methods are based on connectors, in which components of the connectors are attached to the respective systems. The vessels are connected by joining the parts of the connectors.

[0008] EP 3 270 979 B1 shows a sterile connector in which contaminated surfaces are sterilized using UV light before the connection is made. To create a fluid connection, a membrane is pierced after sterilization.

[0009] EP 0 121 980 B1 discloses a device for sterilizing a sterile connector using inductive heating. The sterile connector is inserted into an L-shaped coil. The electromagnetic field heats and sterilizes electrically conductive components of the sterile connector. Only certain parts of the sterile connector are conductive and can therefore be heated inductively. The exact design of the sterile connector is not described.

[0010] US 11,090,478 B2 shows a sterile connector consisting of a socket and a plug. When positioned against each other, the socket and plug form a chamber. This chamber can be sterilized, for example, using UV light, with the components forming the chamber being permeable to the sterilization energy. The sterilization energy is introduced into the sterile connector from outside the sterile connector, for example, in the form of heat or UV light.

[0011] Also known are sterile connectors in which the surfaces forming a contact area are sealed with foil. These foils are removed when two connector parts are connected in such a way that no contamination can enter the interior of the sterile connector. A disadvantage of foil-based sterile connectors is that the two connector parts cannot be separated and subsequently reused without further complex and costly processing steps. The present invention is therefore based on the technical problem of overcoming the disadvantages of the prior art, in particular of providing a sterile connector that enables two closed systems to be connected and reused without complex and costly processing steps.In particular, the present invention is based on the technical problem of connecting a first closed system to a second closed system using a sterile connector in an aseptic and contamination-free manner, i.e., without contamination from undesirable materials, such as bacteria and / or fungi, entering the closed systems from outside, and thus, in particular, meeting regulatory requirements such as GMP. The present invention is also based, in particular, on the technical problem of providing an aforementioned sterile connector and methods using it that make it possible to transfer, i.e., transport, media, in particular biological media, from a first to at least one second closed system in a contamination-free manner, without altering the chemical or biological activity of the transferred media, in particular without being impaired by thermal energy.

[0012] The technical problem is solved by the teaching of the present invention, in particular the teaching of the independent and dependent claims and the description.

[0013] In particular, the present invention solves the underlying technical problem by providing a sterile connector for sterile connection of a first closed system to a second closed system comprising:

[0014] - a socket having at least one connection area to the first or second closed system, at least one plug receptacle configured to receive a plug head, wherein the plug receptacle has side wall surfaces formed by at least one component and an end face of the socket formed by at least one component, at least one channel running from the connection area of ​​the socket to the plug receptacle;

[0015] - a plug having at least one connection area to the first or second closed system, at least one plug head configured for insertion into the plug receptacle, wherein the plug head has side wall surfaces formed by at least one component and an end face of the plug head formed by at least one component, at least one channel extending from the connection area of ​​the plug to the plug head, wherein the plug receptacle and the plug head are designed such that, in the inserted state, the end faces of the plug receptacle and the plug head lie against one another over their entire surface and define a contact surface of the plug receptacle and the plug head, and wherein at least a part of the surface of the plug receptacle defining the contact surface is inductively heatable and / or at least a part of the surface of the plug head defining the contact surface is inductively heatable,that the entire surfaces defining the contact surface are heatable, wherein the channels of the socket and the plug each have at least one, in particular reversible, channel closure system in the frontal region of the respective channel, which is each functionally connected to at least one return element, wherein the at least one return element is each functionally connected to at least one element that is longitudinally displaceable with respect to the respective channel, and wherein the channels are designed to establish a fluid connection between the first closed system and the second closed system.

[0016] The sterile connector according to the invention enables the aseptic and contamination-free connection and separation of the two closed systems without the need for additional tools. Sterile connections can be established and separated as often as required using the sterile connector.

[0017] The sterile connector according to the invention comprises a socket and a plug, wherein the socket and the plug each have at least one connection area to a first or second closed system. The socket further has at least one plug receptacle configured to receive a plug head. The plug further has at least one plug head configured for insertion into the plug receptacle. The plug receptacle and the plug head each have side wall surfaces formed by at least one component and an end face of the socket or plug formed by at least one component. The socket and the plug further each have at least one channel running from the connection area of ​​the socket to the plug receptacle or from the connection area of ​​the plug to the plug head.

[0018] To establish a fluid connection between a first and a second closed system, the closed systems are connected to the designated connection area of ​​the socket or to the connection area of ​​the plug in such a way that one closed system is sterilely connected to the socket and the other to the plug. Preferably, the closed systems are connected to the respective connection area of ​​the socket and the plug in such a way that the respective closed system connected to the connection area of ​​the socket or the plug forms a new closed system with the socket or the plug. Preferably, the respective previous closed system is open after connection to the connection area of ​​the socket or the plug and forms a new closed system with the socket or the plug.Preferably, the respective new closed system is sealed by the channel closure elements of the socket or plug. Preferably, after connecting the closed systems to the socket or plug, sterilization, in particular gamma sterilization, of the respective new closed system consisting of the first or second closed system connected to the socket or plug of the sterile connector according to the invention is carried out. Preferably, the connection of the closed systems to the connection areas of the socket and plug is carried out under sterile conditions. The sterile connector according to the invention can be in a separate state. The socket and plug of the sterile connector according to the invention do not touch each other in a separate state, i.e., they are spatially separated from each other.After connecting the first and second closed systems, the plug head of the plug is pushed far enough into the plug receptacle of the socket that the sterile connector according to the invention is in a plugged-in state. In a preferred embodiment, the closed systems are not yet connected when the sterile connector according to the invention is plugged in and are connected when the sterile connector according to the invention is plugged in, i.e., one closed system is connected to the connection area of ​​the socket and the other closed system is connected to the connection area of ​​the plug. Sterilization, in particular gamma sterilization, of the closed systems connected to the socket or plug of the sterile connector according to the invention is preferably subsequently carried out.

[0019] According to the invention, the plug receptacle and the plug head are designed such that, in the plugged-in state, the end faces of the plug receptacle and the plug head are in full contact with one another and define a contact surface between the plug receptacle and the plug head. In the plugged-in state of the sterile connector according to the invention, the at least one longitudinally displaceable element of the socket and the plug have not yet undergone any longitudinal displacement relative to the respective at least one channel, whereby the end faces of the plug receptacle and the plug head, which are in full contact with one another, are not subjected to any force in the plugged-in state.

[0020] When the end faces of the plug receptacle and the plug head are in full contact with one another as provided according to the invention, at least one of the end faces is in direct contact with the other end face over its entire surface, preferably both of the end faces are in direct contact with their entire surfaces, such that no cavities are formed. The end face surfaces therefore lie directly against one another, so that heat transfer between them can occur with no or no significant energy loss. The end faces of the plug receptacle and the plug head define a contact surface due to the full contact with one another, i.e. a virtual surface which is defined by the end faces of the plug receptacle and the plug head that are in direct contact with one another.

[0021] Preferably, the components forming the end faces, in particular the surfaces of the components forming the end faces, the connector receptacle, and the connector head, are made of inductively heatable and / or heatable material. Preferably, the components forming the end faces of the connector receptacle and / or the connector head have a surface coating, wherein the surface coating is made of inductively heatable and / or heatable material.

[0022] Preferably, it is further provided that the at least one component forming the end faces of one or both end faces, or parts thereof, are made of inductively heatable material and are arranged in the sterile connector such that, upon inductive heating, the entire surfaces defining the contact surface are heated, even if they themselves cannot be inductively heated. The heating and thus sterilization of these surfaces of the plug head and the plug receptacle can therefore be carried out directly by inductive heating of inductively heatable material and by heat transfer from inductively heatable material, for example of a first end face, i.e. of the at least one component forming the first end face, in particular the surface of the at least one component forming the first end face, or the surface coating of the at least one component forming the first end face, to non-inductively heatable,but heatable material of the second end face directly contacting the first end face, i.e. of the at least one component forming the second end face, in particular the surface of the at least one component forming the second end face, or the surface coating of the at least one component forming the second end face,

[0023] In the plugged-in state of the sterile connector according to the invention, the surfaces of the plug receptacle and the plug head, which are in full contact with one another and define a contact surface, are at least partially heated inductively, in particular by a coil, such that the entire surfaces defining the contact surface are heated.

[0024] According to the invention, at least a portion of the surface of the plug receptacle defining the contact surface and / or at least a portion of the surface of the plug head defining the contact surface can be inductively heated such that the entire surfaces defining the contact surface can be heated. Thus, according to the invention, either at least a portion of the surface of the plug receptacle or of the plug head defining the contact surface, or both, can be inductively heated. According to the invention, at least a portion of the plug receptacle or of the plug head, or the portions of the plug receptacle and the plug head of the surface or surfaces defining the contact surface can be inductively heated such that the entire surfaces defining the contact surface can be heated.Thus, if only a portion of the connector receptacle and / or the connector head of the surface defining the contact surface is inductively heatable, the remaining portion of the surface of the connector receptacle and / or the connector head defining the contact surface is also heatable. The heatable remaining portion of the surface of the connector receptacle and / or the connector head defining the contact surface is preferably heated by heat transfer from the inductively heatable at least one portion of the connector receptacle or the connector head or the inductively heatable parts of the connector receptacle and the connector head, such that the entire surfaces defining the contact surface are heatable.

[0025] The entire surface of the connector receptacle defining the contact surface and the entire surface of the connector head defining the contact surface can be inductively heated, or only one entire surface of the connector receptacle or connector head defining the contact surface can be inductively heated and the other entire surface defining the contact surface can be heated, i.e., not inductively heated. Part of a surface of the connector receptacle or connector head defining the contact surface can also be inductively heated, while the other entire surface defining the contact surface can be heated.It is also possible for a part, for example an upper part, of the surface of the plug receptacle defining the contact surface and a part, for example a lower part, of the surface of the plug head defining the contact surface, which does not lie against the part, for example the upper part, of the surface of the plug receptacle defining the contact surface when they lie against one another over their entire surface, to be inductively heated and for the respective other parts of the surfaces of the plug receptacle and the plug head defining the contact surface to be heated, so that during inductive heating the entire surfaces of the plug receptacle and the plug head defining the contact surface are heated.Preferably, the heatable parts of the surfaces of the plug receptacle and plug head that define the contact surfaces, i.e., those that cannot be inductively heated, are heated by heat transfer from the inductively heatable parts of the surfaces of the plug receptacle and plug head that define the contact surface, heated by induction heating, such that the entire surfaces forming the contact surface are heated. According to the invention, therefore, the entire surfaces of the plug receptacle and plug head that define the contact surface are heatable, although it is not necessary for the entire surfaces of the plug receptacle and plug head that define the contact surface to be inductively heated.

[0026] In this way, all surfaces of the plug head and the plug receptacle that define the contact area can be heated and thus sterilized.

[0027] The inductive heatability provided according to the invention is achieved by the inductively heatable surfaces defining the contact surface, in particular the components having the surfaces, being made of an inductively heatable material. The heatability provided according to the invention is also achieved by the heatable surfaces defining the contact surface, in particular the components having the surfaces, being made of a heatable material. In a preferred embodiment, the inductively heatable and / or heatable surfaces represent an integral part of the components of the socket and / or the plug, in particular of the plug head and / or the plug receptacle.In a further embodiment, the components of the socket and / or plug, in particular the plug head and / or the plug receptacle, having the inductively heatable and / or heatable surfaces have a surface coating, wherein the surface coating of the components having the inductively heatable or heatable surfaces is made of a heatable or inductively heatable material. In a preferred embodiment, the component having the surface coating made of an inductively heatable or heatable material is made of a thermally insulating material.Preferably, a component made of an inductively heatable or heatable material having a surface coating, which is made of a thermally insulating material, is advantageous because less energy has to be introduced for sterilization and the cooling time of the heated surfaces is shortened.

[0028] If the channel closure systems of the socket and the plug, each functionally connected to at least one return element and each functionally connected to at least one longitudinally displaceable element, are actuated by a longitudinal displacement, in particular in the direction of a connection area of ​​the socket or the plug and / or away from the end face of the socket or the plug, in particular along the respective channel, of the respective at least one element that is longitudinally displaceable with respect to the respective at least one channel, so that they open the respective channel, a fluid connection is established between the first closed system and the second closed system, as a result of which the sterile connector according to the invention is in an open state.In the open state of the sterile connector according to the invention, the respective at least one element of the socket and the plug that is longitudinally displaceable with respect to the respective at least one channel has undergone a longitudinal displacement in the direction of a connection region of the socket or the plug relative to the respective at least one channel, and a fluid connection is established between two closed systems connected to the sterile connector according to the invention.By longitudinally displacing the respective at least one element which is longitudinally displaceable in relation to the respective at least one channel in the direction of a connection region of the socket or the plug, the respective at least one return element and the respective at least one channel closure system which closes the channels in the non-opened state of the sterile connector according to the invention are actuated, so that the respective at least one channel closure system no longer closes the respective channels and the sterile connector according to the invention is in an open state.

[0029] According to the invention, the sterile connector according to the invention can preferably be in a connected state, wherein in the connected state the plug head is present in the plug receptacle and the at least one element of the socket and the plug that is longitudinally displaceable relative to the respective at least one channel has undergone a longitudinal displacement in the direction of a connection region of the socket or the plug relative to the respective at least one channel, but no fluid connection has yet been established between a first and a second closed system. In the connected state, the respective channel closure system still closes the respective channels, and the longitudinal displacement in the direction of a connection region of the socket or the plug of the respective at least one element that is longitudinally displaceable relative to the respective at least one channel has not yet been fully completed.In the connected state, the sterile connector according to the invention is between the plugged-in and the open state.

[0030] Preferably, the inductively heatable components of the sterile connector according to the invention are arranged and / or designed such that they have no contact with the medium to be transported, in particular with the liquid to be transported, during sterilization.

[0031] Preferably, the heatable components of the sterile connector according to the invention are arranged and / or designed such that they have no contact with the medium to be transported, in particular with the liquid to be transported, during sterilization.

[0032] Preferably, the inductively heatable components and the heatable components of the sterile connector according to the invention are arranged and / or designed such that they have no contact with the medium to be transported, in particular with the liquid to be transported, during sterilization.

[0033] This advantageously prevents damage to the medium to be transported, in particular to the liquid. The sterile connector according to the invention can preferably be sterilized regardless of whether unwanted material, in particular small amounts of solid material or liquids, are present on potentially contaminated surfaces, since the heat can penetrate the material, in particular the small amounts of solid material or liquids on the potentially contaminated surfaces.According to the invention, due to the full-surface contact of the inductively heatable or heatable end faces and optionally side wall surfaces of the plug receptacle and the plug head, the surfaces of the end faces defining the contact surface and optionally side wall surfaces of the plug receptacle and the plug head are heated and thereby sterilized by the inductive heating of the inductively heatable surfaces and the heat transfer from the inductively heated surfaces to the heatable surfaces.

[0034] In this way, all surfaces of the sterile connector according to the invention that may come into contact with the environment when the sterile connector according to the invention is disconnected, i.e., are exposed to potential contamination, and that may come into contact with the medium to be transported when the sterile connector according to the invention is open, are sterilized and no longer exhibit any potential contamination. This preferably eliminates the need for membranes and films for sealing a sterile connector, i.e., for protecting potentially contaminated surfaces of the sterile connector according to the invention, and / or the use of a clean room.Preferably, the sterile connector according to the invention can also be reused directly after use, without the need for complex and cost-intensive process steps, in particular the restoration of membranes and films destroyed by a connection and / or the reuse of a clean room.

[0035] Preferably, cavities between the plug receptacle and the plug head of the sterile connector according to the invention are advantageously minimized, in particular eliminated, by the end faces and optionally the side wall surfaces of the plug receptacle and the plug head in the plugged-in state being in full contact with one another. This preferably prevents air or other undesirable media from being present in the sterile connector according to the invention during the sterilization process, in order to thus increase the reliability of sterilization compared to known sterile connectors, in particular known sterile connectors in which one or more cavities are formed. Preferably, by preventing cavities, the necessary sterilization time is shortened compared to known sterile connectors, in particular known sterile connectors in which one or more cavities are formed.Preferably, in combination with inductive heating, this advantageously enables faster and safer sterilization of the contaminated surfaces compared to known sterile connectors.

[0036] The channels of the socket and plug each have at least one, in particular reversible, channel closure system in the front area of ​​the respective channel. The respective at least one, in particular reversible, channel closure system is functionally connected to at least one reset element. The respective at least one reset element is functionally connected to at least one element that is longitudinally displaceable relative to the respective channel.

[0037] Preferably, the respective at least one longitudinally displaceable element, which is functionally connected to at least one return element, which is functionally connected to at least one channel closure element, eliminates the need for components, in particular films, of the socket and the plug of the sterile connector according to the invention to be destroyed during connection. The channels of the socket and the plug are designed to establish a fluid connection between the first closed system and the second closed system. Preferably, the design of the sterile connector according to the invention advantageously makes it possible for the respective channels of the socket and the plug to be closed again after a first use, i.e. after a fluid connection has been established. Preferably, the fluid connection can be established and broken again more than once.Preferably, no contamination enters the sterile connector according to the invention despite the mechanical displacement of the longitudinally displaceable elements. Preferably, the sterile connector according to the invention can be used multiple times. Preferably, the socket and plug of the sterile connector according to the invention can be separated from each other after the sterile connection with virtually no dripping, in particular without dripping. Advantageously, there is thus advantageously virtually no dead volume, in particular no dead volume, in the sterile connector according to the invention.

[0038] In a preferred embodiment, the channel extending from the connection area of ​​the socket lies fluid-tight against the channel of the plug in a plugged-in, connected or opened state of the sterile connector according to the invention.

[0039] In a preferred embodiment, the frontal outlet or inlet area of ​​the channel of the socket connects fluid-tight to the frontal outlet or inlet area of ​​the channel of the plug.

[0040] In a preferred embodiment, all components of the sterile connector according to the invention that come into contact with the medium to be transported, in particular with the liquid to be transported, are compatible with the medium to be transported, in particular with the liquid to be transported, in particular non-toxic and / or chemically stable, and suitable for the respective process.

[0041] In a preferred embodiment, the at least one component forming the end face of the socket contains at least partially a contact surface, i.e. on a surface forming a contact surface, and / or the at least one component forming the end face of the plug contains at least partially a contact surface, i.e. on a surface forming a contact surface, an inductively heatable material and / or heatable material, or this consists of an inductively heatable material or a heatable material.

[0042] In a preferred embodiment, the plug receptacle and the plug head of the sterile connector according to the invention are designed such that, in the plugged-in state, the end faces and side wall surfaces of the plug receptacle and the plug head lie against one another over their entire surface and define a contact surface of the plug receptacle and the plug head, and wherein the end faces and side wall surfaces of the plug receptacle and the plug head are made of heatable material.

[0043] In a preferred embodiment, the sterile connector for sterilely connecting a first closed system to a second closed system comprises:

[0044] - a socket having at least one connection area to the first or second closed system, at least one plug receptacle configured to receive a plug head, wherein the plug receptacle has side wall surfaces formed by at least one component and an end face of the socket formed by at least one component, at least one channel running from the connection area of ​​the socket to the plug receptacle;

[0045] - a plug having at least one connection area to the first or second closed system, at least one plug head configured for insertion into the plug receptacle, wherein the plug head has side wall surfaces formed by at least one component and an end face of the plug head formed by at least one component, at least one channel extending from the connection area of ​​the plug to the plug head, wherein the plug receptacle and the plug head are designed such that, in the inserted state, the end faces and side wall surfaces of the plug receptacle and the plug head lie against one another over their entire surface and define a contact surface of the plug receptacle and the plug head, and wherein at least a part of the surface of the plug receptacle defining the contact surface can be inductively heated and / or at least a part of the surface of the plug head defining the contact surface can be inductively heated,that the entire surfaces defining the contact surface are heatable, wherein the channels of the socket and the plug each have at least one, in particular reversible, channel closure system in the frontal region of the respective channel, which is each functionally connected to at least one return element, wherein the at least one return element is each functionally connected to at least one element that is longitudinally displaceable with respect to the respective channel, and wherein the channels are designed to establish a fluid connection between the first closed system and the second closed system.

[0046] In a preferred embodiment, the sterile connector according to the invention has a seal, in particular an annular seal, that surrounds the surfaces defining the contact surface on all sides peripherally. In a preferred embodiment, the sterile connector according to the invention has a seal, in particular an annular seal, that surrounds at least part of the surfaces, in particular the entire surfaces, defining the contact surface on all sides peripherally. In a preferred embodiment, the end face of the plug receptacle and / or the plug head of the sterile connector according to the invention is partially formed by a seal, in particular an annular seal, that surrounds at least part of the contact surface defined by the end faces of the plug receptacle and the plug head on all sides peripherally on all sides, in particular the entire contact surface defined by the end faces of the plug receptacle and the plug head, in particular a component forming the end face has this on the surface defining the contact surface.In a preferred embodiment, the side wall surface of the plug receptacle and / or the plug head of the sterile connector according to the invention is partially formed by a seal, in particular an annular seal, which peripherally encloses at least part of the contact surface defined by the end faces and side wall surfaces of the plug receptacle and the plug head on all sides, in particular a component forming the side wall surface has this on the surface defining the contact surface.

[0047] In a preferred embodiment, the seal, which peripherally surrounds the surfaces defining the contact area on all sides, in particular the annular seal, does not form part of the end face, in particular not the end face. In a preferred embodiment, the seal, which peripherally surrounds the surfaces defining the contact area on all sides, is formed at the transition from the side wall surfaces to the end face of the plug and / or socket.

[0048] Preferably, when the surfaces defining the contact surface are in full contact with one another, no unwanted material, i.e., no contamination, reaches the surfaces to be heated, i.e., sterilized, through the seal, particularly after the sterilization step. This preferably prevents the penetration of unwanted materials, in particular contaminants, into the interior, in particular into the channel, of the sterile connector according to the invention, particularly after the sterilization step.

[0049] In a preferred embodiment, the at least one component forming the side wall surface of the plug receptacle contains, at least partially over a contact surface, and / or at least one component forming the side wall surface of the plug head contains, at least partially over a contact surface, an inductively heatable material and / or a heatable material, or this consists of an inductively heatable material or a heatable material.

[0050] In a preferred embodiment, the inductively heatable material of the inductively heatable components is a stainless steel, in particular a stainless steel according to EN 10020, in particular stainless steel 304-V2A, 1.4301, X5CrNil8-10.

[0051] In a preferred embodiment, the heatable material of the heatable components is a plastic, in particular PEEK (polyetheretherketone) and / or PFA (perfluoroalkoxy).

[0052] In a preferred embodiment, the heat-resistant material of the heat-resistant components is a plastic, in particular polypropylene and / or polycarbonate.

[0053] In a preferred embodiment, the socket of the sterile connector according to the invention has one to ten channels, in particular one to eight, in particular one to six, in particular one, in particular two, in particular three, in particular four, in particular five, in particular six, channels.

[0054] In a preferred embodiment, the plug of the sterile connector according to the invention has one to ten channels, in particular one to eight, in particular one to six, in particular one, in particular two, in particular three, in particular four, in particular five, in particular six, channels.

[0055] In a preferred embodiment, the at least one channel of the socket or plug of the sterile connector according to the invention is formed from at least one component, in particular one to ten components, in particular one to five, in particular two to four, in particular one, in particular two, in particular three, in particular four, in particular five, in particular six, components. In a preferred embodiment, the at least one channel of the socket or plug of the sterile connector according to the invention is constructed from at least one component selected from the group consisting of a channel component, a connection component, a plunger, a housing, a front housing part, in particular from at least one component according to Figures 1 to 10.

[0056] In a preferred embodiment, the at least one channel of the socket or plug of the sterile connector according to the invention is encapsulated, in particular enclosed by an encapsulation. In a preferred embodiment, the encapsulation is at least partially, in particular completely, formed in the form of a plunger of the socket or plug.

[0057] In a preferred embodiment, the at least one component forming the at least one channel of the socket or plug of the sterile connector according to the invention comprises or consists of a heat-resistant material, wherein the heat-resistant component is a plastic, in particular polypropylene and / or polycarbonate.

[0058] In a preferred embodiment, the socket of the sterile connector according to the invention has one to ten longitudinally displaceable elements, in particular two to eight, in particular three to six, in particular one, in particular two, in particular three, in particular four, in particular five, in particular six, longitudinally displaceable elements.

[0059] In a preferred embodiment, the plug of the sterile connector according to the invention has one to ten longitudinally displaceable elements, in particular two to eight, in particular three to six, in particular one, in particular two, in particular three, in particular four, in particular five, in particular six, longitudinally displaceable elements.

[0060] In a preferred embodiment, the at least one component of the plug receptacle forming the end face and / or the at least one component of the plug head forming the end face is a longitudinally displaceable element.

[0061] In a preferred embodiment, the at least one longitudinally displaceable element of the socket or plug of the sterile connector according to the invention is selected from the group consisting of a plunger, a front ring, an inner seal of the front ring, a seal of the plunger, a front seal, a front cover, a connecting channel component, a housing, a mounting cover, a rear seal, a magnet cover, a front pane, an inner magnet, a plunger holder, a sealing ring and an inner seal, in particular at least one longitudinally displaceable element according to Figures 1 to 10.

[0062] In a preferred embodiment, the at least one longitudinally displaceable element of the socket or plug of the sterile connector according to the invention comprises or consists of a heat-resistant material.

[0063] In a preferred embodiment, the socket of the sterile connector according to the invention has one to ten reset elements, in particular one to five, in particular two to four, in particular one, in particular two, in particular three, in particular four, in particular five, in particular six, reset elements.

[0064] In a preferred embodiment, the plug of the sterile connector according to the invention has one to ten reset elements, in particular one to five, in particular one to four, in particular one, in particular two, in particular three, in particular four, in particular five, in particular six, reset elements.

[0065] In a preferred embodiment, the at least one return element of the socket or plug of the sterile connector according to the invention is an elastic machine element or a magnetic device. The sterile connector according to the invention is sterilized by heat and enables automated connection without manual intervention.

[0066] In a preferred embodiment, the at least one return element of the socket or plug of the sterile connector according to the invention is selected from the group consisting of an elastic machine element, in particular a spring, a return spring, an outer return spring and an inner return spring, in particular at least one return element according to Figures 1 to 10.

[0067] In a preferred embodiment, the at least one return element, in particular the return spring, of the socket and / or the plug is encapsulated, in particular enclosed by an encapsulation. This preferably ensures that the at least one return element is no longer flushed with the fluid to be transmitted. This preferably ensures that, by encapsulating the at least one return element, in particular the at least one return spring, of the socket and / or the plug, fewer deposits accumulate in the socket and / or the plug, in particular on the return element, particularly when the sterile connector according to the invention is used multiple times.

[0068] In a preferred embodiment, the at least one reset element of the socket and / or the plug of the sterile connector according to the invention comprises a magnetic device, in particular consisting of at least one magnet arranged outside the socket or the plug, in particular also referred to as an external reset magnet, and at least one, in particular two, magnets arranged inside the socket or the plug, in particular also referred to as an internal reset magnet, which interact with the magnet arranged outside the socket or the plug.

[0069] In a preferred embodiment, the at least one reset element of the socket and / or the plug of the sterile connector according to the invention comprises a magnetic device, in particular consisting of at least one, in particular two, magnets arranged within the socket or plug, which cooperate with a housing of the socket or plug, in particular also referred to as an internal reset magnet, wherein the housing of the socket or plug is magnetic, in particular comprises magnetic material, in particular consists of magnetic material, in particular in an intended displacement region of the internal reset magnet.

[0070] The sterile connector according to the invention is preferably in a disconnected or plugged-in state in a starting position of the magnetic device, in particular of the inner reset magnet. The sterile connector according to the invention is preferably in a connected state in an intermediate position of the magnetic device, in particular of the inner reset magnet. The sterile connector according to the invention is preferably in an open state in an end position of the magnetic system, in particular of the inner reset magnet.In a preferred embodiment, the respective inner return magnet of the socket or plug is displaceable within the length of the respective outer return magnet of the socket or plug, in particular by means of the longitudinally displaceable elements of the socket or plug, in particular longitudinally displaceable, in particular wherein the outer return magnet remains rigid, in particular such that during displacement the respective inner return magnets are not pushed beyond a limit point, in particular a start or end point of the length of the respective outer retention magnet. In a preferred embodiment, the magnets of the magnetic device arranged outside the socket or plug are ring magnets or electromagnets. In a particularly preferred embodiment, the magnets of the magnetic device arranged outside are arranged, in particular fixed, on the outer surface of the housing of the socket or plug.

[0071] In a preferred embodiment, the magnets of the magnetic device arranged within the socket or plug are ring magnets or electromagnets.

[0072] A sterile connector according to the invention preferably has a magnet system and / or a magnet device.

[0073] In a preferred embodiment, the at least one return element of the socket or plug of the sterile connector according to the invention comprises or consists of a heat-resistant material selected from the group consisting of a stainless spring steel, in particular stainless steel 1.4310 and / or 1.4568 according to EN 10270-3-SH, and a plastic, in particular polyacetal (POM, polyoxymethylene).

[0074] In a preferred embodiment, the socket of the sterile connector according to the invention has one to ten channel closure systems, in particular one to five, in particular one to four, in particular one, in particular two, in particular three, in particular four, in particular five, in particular six, channel closure systems.

[0075] In a preferred embodiment, the plug of the sterile connector according to the invention has one to ten channel closure systems, in particular one to five, in particular one to four, in particular one, in particular two, in particular three, in particular four, in particular five, in particular six, channel closure systems.

[0076] In a preferred embodiment, the at least one channel closure system of the socket of the sterile connector according to the invention consists of one to ten components, in particular one to five, in particular two to four, in particular one, in particular two, in particular three, in particular four, in particular five, in particular six, components.

[0077] In a preferred embodiment, the at least one channel closure system of the plug of the sterile connector according to the invention consists of one to ten components, in particular one to five, in particular two to four, in particular one, in particular two, in particular three, in particular four, in particular five, in particular six, components. In a preferred embodiment, the at least one component of the at least one channel closure system is selected from the group consisting of a plunger, a connecting channel component, a front panel, a sealing ring, and an inner seal, in particular at least one component of the at least one channel closure system according to Figures 1 to 10.

[0078] In a preferred embodiment, the at least one component of the at least one channel closure system of the socket or plug of the sterile connector according to the invention comprises or consists of a heat-resistant material, wherein the heat-resistant material is a plastic.

[0079] In a preferred embodiment, the plug receptacle and the plug head are designed such that, in the plugged-in state, the end faces of the plug receptacle and the plug head lie against each other over their entire surface and define a contact surface of the plug receptacle and the plug head and the side wall surfaces lie against each other over their entire surface or the side wall surfaces do not lie against each other over their entire surface.

[0080] In a preferred embodiment, the components forming the channels of the socket and the plug, at least one component of the at least one channel closure system of the socket and the plug, and the components forming the at least one connection area of ​​the socket and the plug are made of a heat-resistant material.

[0081] The sterile connector according to the invention is advantageously designed such that the components to be heated do not come into contact with the medium to be transported, in particular with the liquid to be transported, during sterilization. This preferably prevents damage to the medium to be transported, in particular to the liquid to be transported.

[0082] In a preferred embodiment, the components with surfaces potentially coming into contact with the environment, in particular potentially contaminated surfaces, are made of a heatable material or an inductively heatable material.

[0083] In a preferred embodiment, the components which have surfaces that come into contact with the environment before sterilization comprise, in particular consist of, a heatable and / or an inductively heatable material. The components which have surfaces that come into contact with the medium to be transported after sterilization preferably comprise, in particular consist of, a heatable and / or an inductively heatable material. The components which have surfaces that come into contact with the environment before sterilization and with the medium to be transported after sterilization, both also referred to as potentially contaminated surfaces or surfaces to be sterilized, preferably comprise, in particular consist of, a heatable and / or an inductively heatable material.

[0084] In a preferred embodiment, potentially contaminated surfaces, i.e., surfaces to be sterilized, are sealed from the environment by at least one seal, preventing contamination. This ensures that all surfaces of the sterile connector according to the invention that come into contact with the environment and / or, after sterilization, with the medium to be transported, can be sterilized.

[0085] To provide a sterile connector according to the invention, the surfaces that come into contact with the environment before sterilization and with the medium to be transported after sterilization, i.e., potentially contaminated surfaces or surfaces to be sterilized, are sterilized. Sterilization of the surfaces defining the contact surface is achieved by inductive heating.

[0086] Preferably, a sterile sterile connector according to the invention is provided by sterilizing the surfaces to be sterilized, wherein only surfaces and spaces of the sterile connector according to the invention that come into contact with the medium to be transported, i.e. surfaces and spaces that should not come into contact with the environment before, during, or after the connection of the socket and plug, but with the medium to be transported, are sealed by a seal so that they do not come into contact with the environment. This preferably prevents contamination from the environment to the medium. Preferably, these surfaces that only come into contact with the medium to be transported, in particular the components forming the surfaces or a superficial coating of the components forming the surfaces, i.e. the components that cannot be contaminated, are not heatable and / or not inductively heatable.Preferably, a sterile connector according to the invention is provided, wherein the surfaces defining the contact surface in the plugged-in state are heatable and / or inductively heatable such that all surfaces defining the contact surface are heatable, in particular the surfaces to be sterilized are heatable and / or inductively heatable, and wherein the surfaces that only come into contact with the medium to be transported and are not intended to come into contact with the environment are sealed by at least one seal such that they cannot come into contact with the environment. In a preferred embodiment, the at least one return element is a spring system.

[0087] In a preferred embodiment, the at least one return element is a magnetic device.

[0088] In a preferred embodiment, the at least one return element is a spring system or a magnetic device and is designed to open the channel closure system of the socket and plug upon compression of the spring system or displacement of the magnetic device, in particular by the at least one longitudinally displaceable element of the socket and / or plug, in particular up to a stop point, thereby forming a fluid connection between the first closed system and the second closed system via the channel of the socket and the channel of the plug. The sterile connector according to the invention is preferably in an open state due to the established fluid connection.

[0089] In a preferred embodiment, the sterile connector according to the invention has a foldable sealing sleeve, in particular made of an elastic material, formed in particular on the plug.

[0090] In a further embodiment of the sterile connector according to the invention, the longitudinally displaceable elements of the socket and the plug are displaced by a magnetic force applied from the outside.

[0091] In a preferred embodiment, the sterile connector according to the invention has a magnet system formed in particular on the socket or the plug, wherein the magnet system comprises at least one first magnet and at least one second magnet or at least one magnetic material, wherein either the at least one first magnet, in particular a permanent magnet or electromagnet, or the at least one magnetic material is formed outside on the socket or on the plug and the at least one first or second magnet or at least one magnetic material is formed inside the socket or the plug, in particular both at the same height of the longitudinal axis of the socket or the plug, in particular on the connection area side to the at least one longitudinally displaceable element, in such a way that the at least one longitudinally displaceable element is longitudinally displaceable by the magnet system.In a preferred embodiment, the magnetic material comprises or consists of neodymium or iron.

[0092] In a preferred embodiment, the magnet outside the socket or plug is a permanent magnet, in particular a ring magnet, or an electric lifting magnet.

[0093] In a preferred embodiment, the magnet outside the socket or plug is an electric lifting magnet, wherein displacement can be controlled via electrical signals.

[0094] In a preferred embodiment, the inductively heatable material of the sterile connector according to the invention is heated by an inductive heating device, in particular a coil, in particular an induction coil. In a preferred embodiment, an alternating voltage is applied to the inductive heating device, in particular the coil, in particular the induction coil. Preferably, the inductively heatable components of the sterile connector according to the invention, which are located in the inductive heating device and comprise inductively heatable material, are thereby inductively heated and sterilized.

[0095] In a preferred embodiment, the sterile connector according to the invention has at least one contact surface sealing system designed to seal the surfaces defining the contact surface and / or at least one channel sealing system designed to seal the channel of the socket and the channel of the plug.

[0096] In a preferred embodiment, the at least one contact surface sealing system of the socket or plug of the sterile connector according to the invention consists of one to ten components, in particular one to five, in particular two to four, in particular one, in particular two, in particular three, in particular four, in particular five, in particular six, components.

[0097] In a preferred embodiment, the at least one component of the at least one contact surface sealing system is selected from the group consisting of a rear seal, a front seal and an outer seal, in particular at least one component of the at least one contact surface sealing system according to Figures 1 to 10.

[0098] In a preferred embodiment, the at least one channel sealing system of the socket or plug of the sterile connector according to the invention consists of one to ten components, in particular one to five, in particular two to four, in particular one, in particular two, in particular three, in particular four, in particular five, in particular six, components.

[0099] In a preferred embodiment, the at least one component of the at least one channel sealing system is selected from the group consisting of a seal, a sealing ring, a front seal, an inner seal and a sealing ring, in particular at least one component of the at least one channel sealing system according to Figures 1 to 10.

[0100] In a preferred embodiment, the first and / or the second closed system is a vessel, in particular a bottle, in particular a crimp bottle, in particular made of glass or plastic, a bag, in particular a cell culture bag or blood bag, a container, in particular a sterile container, a canister, a cell culture container, a reactor, a tube or any desired complex closed system.

[0101] In a further aspect, the present invention relates to a method for sterilely connecting a first closed system to a second closed system, comprising the following method steps: a) Providing a first and a second closed system, each of which is reversibly or integrally connected to a socket or a plug of at least one sterile connector according to the invention and a device for inductive heating, b) Bringing the socket and the plug of the at least one sterile connector together in the plugged-in state, in particular such that the end faces of the plug receptacle and the plug head lie against one another over their entire surface and define a contact surface of the plug receptacle and the plug head, c) Inductively heating the sterile connector, in particular at least part of the surface of the plug head and / or the plug receptacle defining the contact surface, to a temperature and for a time,which is sufficient to sterilize the surfaces defining the contact surface, in particular at least 160 °C, in particular 180 °C, by means of the inductive heating device, and d) opening the channel closure systems of the plug and the socket of the at least one sterile connector, whereby a fluid connection is established between the first and second closed systems through the at least one sterile connector.

[0102] Preferably, the sterile connector according to the invention is in a separated state in process step a).

[0103] In a preferred embodiment, in method step b) of the method according to the invention, the socket and the plug of the at least one sterile connector are brought together in the plugged-in state in such a way that the end faces and optionally the side wall surfaces of the plug receptacle and the plug head lie against one another over their entire surface and define a contact surface of the plug receptacle and the plug head.

[0104] Preferably, in method step b), the plug receptacle of the socket and the plug head of the plug of the at least one sterile connector according to the invention are positioned with their end faces and optionally side wall surfaces abutting one another over their entire surface in such a way that they define a contact surface of the plug receptacle and the plug head. Preferably, the sterile connector according to the invention is in a plugged-in state due to the end faces and optionally the side wall surfaces of the plug receptacle and the plug head abutting one another over their entire surface in method step b). Preferably, at least part of the surface of the plug receptacle defining the contact surface can be inductively heated and / or at least part of the surface of the plug head defining the contact surface can be inductively heated, so that all of the surfaces defining the contact surface can be heated.

[0105] Preferably, in method step c), the inductively heatable part of the surface of the plug head and / or the plug receptacle defining the contact surface is inductively heated to a temperature and for a time sufficient to sterilize the surfaces defining the contact surface, so that the entire surface of the plug receptacle and the plug head defining the contact surface is heated. Advantageously, all contaminants, in particular biological contaminants, on the surfaces of the plug receptacle and the plug head defining the contact surface are killed and / or destroyed. Thus, the entire surface of the plug receptacle and the plug head of the sterile connector according to the invention defining the contact surface is preferably sterilized in method step c).In a preferred embodiment, in process step c) the inductively heatable part of the surface of the plug head and / or the plug receptacle defining the contact surface is heated to a temperature of 30 to 1000 °C, in particular 30 to 500 °C, in particular 100 to 180 °C, in particular 120 to 180 °C, in particular 160 to 180 °C, in particular 100 °C, in particular 120 °C, in particular 160 °C, in particular 180 °C.

[0106] In a preferred embodiment, in method step c) the inductively heatable part of the surface of the plug head and / or the plug receptacle defining the contact surface is heated for a time of 1 to 1000 seconds, in particular 10 to 600 seconds, in particular 30 to 300 seconds, in particular 1 second, in particular 30 seconds, in particular 60 seconds, in particular 180 seconds, in particular 300 seconds, in particular 600 seconds.

[0107] In a preferred embodiment, in the method according to the invention, the displacement of the at least one longitudinally displaceable element of the plug or the socket of the at least one sterile connector, in particular the socket of the at least one sterile connector, in method step d) is carried out by means of magnetic force, in particular by means of a ring magnet or an electric lifting magnet.

[0108] In a preferred embodiment, in the method according to the invention, after method step c) and before the transport of the liquid from the first and / or second closed system in a method step c1), the sterile connector, in particular the at least part of the surface of the plug head and / or the plug receptacle defining the contact surface, is cooled, in particular by flushing or by air.

[0109] Preferably, after process step c) and before process step d), in a process step c1), the heated surfaces are allowed to cool to a temperature compatible with the liquid to be transferred, in particular to 20 to 37 °C, in particular 37 °C.

[0110] In a preferred embodiment of the method according to the invention, the opening of the channel closure system of the socket and the plug of the at least one sterile connector in method step d) is carried out by displacing the at least one longitudinally displaceable element to actuate the at least one return element, wherein in particular the at least one return element is a spring system and the actuation is a compression of the spring system. Preferably, the sterile connector according to the invention is in an open state after opening in method step d). Preferably, in method step d), the respective channels of the socket and the plug are connected to one another for transporting a liquid from a first closed system or a second closed system into the other closed system.

[0111] Preferably, the closed systems sterilely connected using a sterile connector according to the invention are separated from one another in a method step e), in particular by pulling the plug out of the socket, in particular the plug head of the plug out of the plug receptacle of the socket, of the sterile connector according to the invention. Preferably, in method step e), the at least one longitudinally displaceable element and the at least one compressed return element that were displaced longitudinally during opening according to method step d) are returned to their initial position. Preferably, the establishment of a fluid connection according to method steps b) to e) with the sterile connector according to the invention is reversible. Preferably, method steps b) to e) can be carried out multiple times with the same sterile connector according to the invention, in particular 1 to 1000 times, in particular 1 to 100 times, in particular 1 to 10 times.

[0112] In a further aspect, the present invention relates to a device for, in particular automated, sterile connection of a first closed system to a second closed system, in particular by means of a method according to the invention, comprising

[0113] - at least one sterile connector according to the invention,

[0114] - a first closed system connected to the socket or plug of the at least one sterile connector, in particular integrally or reversibly,

[0115] - a second closed system connected to the socket or plug of the at least one sterile connector, in particular integrally or reversibly, and, optionally,

[0116] - at least one device for inductive heating.

[0117] In a preferred embodiment, the device according to the invention further comprises

[0118] - a, in particular motorized, linear unit on which either the socket or the plug of the at least one sterile connector with at least a part of the first or second closed system is located, and - a fastening for fixing either the plug or the socket of the at least one sterile connector with at least a part of the first or second closed system.

[0119] Preferably, the first or second closed system is located completely with either the socket or the plug of the at least one sterile connector on the linear unit.

[0120] Preferably, at least one part of the first or second closed system located on the linear unit is a hose.

[0121] Preferably, the device according to the invention advantageously automates the sterile connection of a first closed system to a second closed system by the motorized linear unit.

[0122] In a preferred embodiment of the device according to the invention, the device for inductive heating is an induction coil, in particular in the form of a spiral or a horseshoe, which can be arranged at least around the outer circumference of the socket or the plug of the at least one sterile connector, in particular around the socket or the plug of the at least one sterile connector, which is fixed to the fastening.

[0123] In a preferred embodiment of the device, the linear unit, in particular a motorized one, is a power-driven mechanical guide and has a movable carriage on which the socket or the plug of the at least one sterile connector can be fixed, and wherein the device further comprises a control unit which can carry out the connection between the socket or the plug of the at least one sterile connector located on the linear unit and the socket or the plug of the at least one sterile connector fixed to the fastening.

[0124] In a preferred embodiment of the device according to the invention, the device further comprises a device which can cool the at least one sterile connector preferably by means of a gas stream, preferably air.

[0125] In a further aspect, the present invention relates to a method for the sterile transfer of biologically active media, comprising the following method steps: a) providing a first and a second closed system, each of which is reversibly or integrally connected to a socket or a plug of at least one sterile connector according to the invention, and either the first and / or the second closed system contains a biologically active medium, and a device for inductive heating, b) bringing the socket and the plug of the at least one sterile connector together in the plugged-in state, in particular such that the end faces of the plug receptacle and the plug head lie against one another over their entire surface and define a contact surface of the plug receptacle and the plug head, c) inductive heating of the sterile connector,in particular of at least a part of the surface of the plug head and / or the plug receptacle defining the contact surface, to a temperature and for a time sufficient to sterilize the surfaces defining the contact surface, in particular at least 160 °C, in particular 180 °C, by means of the inductive heating device, and d) opening the channel closure systems of the plug and the socket of the at least one sterile connector, whereby a fluid connection is established between the first and second closed systems through the at least one sterile connector.

[0126] In a preferred embodiment, in method step b) of the method according to the invention, the socket and the plug of the at least one sterile connector are brought together in the plugged-in state in such a way that the end faces and optionally the side wall surfaces of the plug receptacle and the plug head lie against one another over their entire surface and define a contact surface of the plug receptacle and the plug head.

[0127] Preferably, in method step b), the plug receptacle of the socket and the plug head of the plug of the at least one sterile connector according to the invention are positioned with their end faces and optionally side wall surfaces abutting one another over their entire surface in such a way that they define a contact surface of the plug receptacle and the plug head. Preferably, the sterile connector according to the invention is in a plugged-in state due to the end faces and optionally the side wall surfaces of the plug receptacle and the plug head abutting one another over their entire surface in method step b). Preferably, at least part of the surface of the plug receptacle defining the contact surface can be inductively heated and / or at least part of the surface of the plug head defining the contact surface can be inductively heated, so that all of the surfaces defining the contact surface can be heated.In a preferred embodiment of the method, after method step c) and before the transport of the biologically active medium from the first and / or second closed system, in a method step c1), the sterile connector, in particular at least part of the surface of the plug head and / or the plug receptacle defining the contact surface, is cooled to a biologically active medium-compatible temperature, in particular below 37 °C.

[0128] In a preferred embodiment of the method according to the invention, the biologically active medium comprises, in particular consists of, at least one, biologically active material and at least one, in particular one, biologically compatible liquid or at least one, in particular one, biologically compatible gas.

[0129] In a preferred embodiment of the method according to the invention, the at least one biologically active material is selected from the group consisting of animal cells, human cells, plant cells, fungal cells, immune cells, in particular human immune cells, for cancer therapy, cells for immunotherapy, growth factors, bacteria, viruses, viroids, proteins, peptides, enzymes and combinations thereof.

[0130] In a preferred embodiment of the method according to the invention, the at least one biologically compatible liquid is selected from the group consisting of water, buffer solution, stock solution, saline solution, physiological saline solution, a cell culture medium or cell culture solution and combinations thereof.

[0131] In a preferred embodiment of the method according to the invention, the biologically compatible gas is selected from the group consisting of nitrogen, a noble gas, in particular argon, oxygen and carbon dioxide.

[0132] In a preferred embodiment of the method according to the invention for the sterile transfer of biologically active media, the biologically active medium to be transferred comprises immune cells for cancer therapy, in particular in water, cell culture medium, physiological saline solution, buffer solution, Ringer's solution or combinations thereof, in particular it consists thereof, wherein the method comprises the following method steps: a) providing a first and a second closed system, wherein these are reversibly or integrally connected each to a socket or a plug of at least one sterile connector according to the invention and either the first and / or the second closed system contains the biologically active medium comprising immune cells for cancer therapy, in particular in water, cell culture medium, physiological saline solution, buffer solution, Ringer's solution or combinations thereof, in particular consisting thereof, and a device for inductive heating,b) Bringing the socket and the plug of the at least one sterile connector together in the plugged-in state, in particular such that the end faces of the plug receptacle and the plug head lie against one another over their entire surface and define a contact surface of the plug receptacle and the plug head, c) Inductively heating the sterile connector, in particular at least a portion of the surface of the plug head and / or the plug receptacle defining the contact surface, to a temperature and for a time sufficient to sterilize the surfaces defining the contact surface, in particular at least 160°C, in particular 180°C, by means of the inductive heating device, and d) Opening the channel closure systems of the plug and the socket of the at least one sterile connector, thereby establishing a fluid connection between the first and second closed systems through the at least one sterile connector.

[0133] In a preferred embodiment, a sterile connector according to the invention is provided in method step a), wherein the components forming the channels of the socket and the plug, at least one component of the at least one channel closure system of the socket and the plug and the components forming the at least one connection region of the socket and the plug are made of a heat-resistant material.

[0134] In this way, it is preferably achieved that only the heatable materials, i.e. in particular the surfaces of the plug head and / or the plug receptacle that define the contact surface, are heated by the components made of heat-resistant materials, and a path to be traveled by the liquid to be transferred, in particular with the exception of the heated surfaces of the plug receptacle and the plug head that define the contact surface, is not heated. This preferably ensures that method step d) can be carried out instantaneously after method step c). In a preferred embodiment, method step d) is carried out instantaneously after method step c).

[0135] Preferably, after process step c) and before process step d), in a process step c1), the heated surfaces are allowed to cool to a temperature compatible with the liquid to be transferred, in particular to 20 to 37 °C, in particular 37 °C.

[0136] In a further aspect, the present invention also relates to the use of a sterile connector according to the invention or a device according to the invention for the sterile connection of a first closed system to a second closed system.

[0137] In a preferred embodiment, a use according to the invention is a use in which two closed systems have to be connected to one another, in particular in medical technology, pharmaceutical production, cancer therapy or immunotherapy, in particular of cancer diseases.

[0138] Preferably, in a use according to the invention, the use of clean rooms can be dispensed with or, compared to known applications, clean rooms with a lower degree of purity, in particular according to DIN EN ISO 14644, can be used.

[0139] In the context of the present invention, the term "closed system" refers to a system that exchanges only gaseous matter, in particular no matter, with its environment. Preferably, a closed system does not exchange solid or liquid matter with its environment. Preferably, no contamination can penetrate into a closed system.

[0140] In the context of the present invention, the term “socket” is understood to mean a component, in particular a sleeve, having a cavity for receiving a plug. A socket is preferably understood to mean the female component of a plug connection. A mechanical connection between the socket and the plug is preferably established by receiving the plug in the cavity provided for this purpose in the socket. The cavity of the socket is preferably also referred to as a plug receptacle. The plug receptacle is preferably defined by the space enclosed by the end face and the surface of the side wall surfaces of the plug receptacle. The plug receptacle is preferably the part of the socket that encloses the plug, in particular the plug head. A socket according to the present invention is preferably understood to mean a socket according to Figures 1 to 10.Preferably, the plug receptacle serves for contacting, in particular for the full-surface contact between the end face of the plug receptacle and the end face of the plug head of the sterile connector according to the invention.

[0141] In the context of the present invention, the term "plug" refers to a component that is inserted into a socket to establish a mechanical connection. A plug is preferably understood to be the male component of a plug connection. A plug preferably has a plug head that is enclosed by the plug receptacle of a socket. The plug head preferably has an end face and side wall surfaces. A plug according to the present invention is preferably understood to be a plug according to Figures 1 to 10.

[0142] In the context of the present invention, the term “end face” is understood to mean a frontal surface formed by at least one component. The end face is preferably formed by the surface of the at least one component forming the end face. The end face is preferably flat. The end face is preferably arranged at an angle, in particular at right angles, to the side wall surfaces, as seen in the longitudinal section of the plug receptacle or the plug head. The end face is preferably continuous, i.e., without interruption, so that when two end faces bear against one another over their entire surface, no chamber, in particular no cavity, is formed.

[0143] Preferably, the end face of the connector head is the frontal surface of the connector. Preferably, the end face of the connector head is located most distally in the longitudinal direction of the connector, i.e., furthest from the connection area of ​​the connector. Preferably, the end face of the connector receptacle serves to contact the end face of the connector head.

[0144] Preferably, the end face of the plug receptacle within the hollow body formed by the plug receptacle is spatially closer to the connection area of ​​the socket than the side wall surfaces of the plug receptacle.

[0145] Preferably, an end face of the plug receptacle or of the plug head according to the present invention is understood to mean an end face of the plug receptacle or of the plug head according to Figures 1 to 10. Preferably, the end faces of the plug receptacle and of the plug head can also be non-planar, for example concave or convex or wavy, or have any other possible shape, in which case the respective other end face is designed as a negative form of the other end face, i.e. is designed such that when the two end faces come into contact, they rest against one another over their entire surface, in particular the entire surfaces of the end faces rest against one another over their entire surface. Preferably, for example, if the end face of the plug receptacle has a concave shape, the end face of the plug head is designed in a convex shape so that it forms the negative form of the concave shape.

[0146] Preferably, the at least one component forming an end face forms an end wall.

[0147] In the context of the present invention, the term "side wall surface" is understood to mean a wall surface of the plug head or plug receptacle formed by at least one component and adjacent to an end face, preferably adjacent to the peripheral periphery of the end face. Preferably, the side wall surface—as viewed in longitudinal section through the plug receptacle or plug head—is arranged at an angle, in particular at right angles, to the end face. Preferably, all side wall surfaces facing the cavity of the plug receptacle and the end face of the plug receptacle enclose the side wall surfaces and the end face of the plug head of the sterile connector according to the invention.

[0148] Preferably, the at least one component forming a side wall surface builds up a side wall.

[0149] In connection with the present invention, the terms “heatable end face”, “inductively heatable end face”, “heatable side wall face” and “inductively heatable side wall face” are understood to mean that the components forming the respective faces, in particular their surfaces, or the surface coating of the components forming the respective faces are made of inductively heatable or heatable material and thus the respective faces are heatable or inductively heatable.

[0150] In the context of the present invention, the term "contact surface" is understood to mean a virtual surface defined by the direct contact, i.e., mutual contact, of at least two real surfaces. Preferably, the two real, mutually contacting surfaces are the surfaces of the end faces and, optionally, the side wall surfaces of the socket and plug of the sterile connector according to the invention. Preferably, the mutual contact of the surfaces is a full-surface contact of the surfaces, in particular a direct contact of the surfaces, in particular the end faces and, optionally, the side wall surfaces of the socket and plug of the sterile connector according to the invention.

[0151] In the context of the present invention, the term "channel closure system" is understood to mean a system consisting of at least one component of a sterile connector according to the invention, which, through reversible actuation, enables a fluid connection between a first and a second closed system. Preferably, the at least one component of the channel closure system of a sterile connector according to the invention closes a channel of a socket or a plug of a sterile connector according to the invention when the sterile connector according to the invention is not opened. Preferably, the respective channel of the socket and the plug of the sterile connector according to the invention is opened by actuating the channel closure systems, whereby a fluid connection can be established between a first and a second closed system.Preferably, channel closure systems are designed to form or close a fluid connection between the first and the second closed system.

[0152] In the context of the present invention, the term "resetting element" refers to an element that is functionally connected to a channel closure system of the sterile connector according to the invention such that, when the reset element is in its resting state, the channel closure system closes the channel of the socket or plug. The reset element is preferably a spring that is in a state other than its resting state due to compression. A reset element is preferably activated by an external force.

[0153] In the context of the present invention, the term "longitudinally displaceable element" refers to a component that is longitudinally displaceable relative to a respective channel of the socket or plug of the sterile connector according to the invention. Preferably, a longitudinally displaceable element can simultaneously be a component of a channel closure system.

[0154] In the context of the present invention, the term "made of inductively heatable material" is understood to mean, for example, that a component made of inductively heatable material contains inductively heatable material, or consists of inductively heatable material. In the context of the present invention, the term "magnetic star" is understood to mean a system consisting of a permanent magnet or an electromagnet and at least one magnet or magnetic material functionally connected thereto.

[0155] In the context of the present invention, the term “contact surface sealing system” is understood to mean a sealing system which seals the contact surface of the sterile connector according to the invention so that almost no contamination, in particular no contamination from the environment, reaches the contact surface.

[0156] In the context of the present invention, the term “channel sealing system” is understood to mean a sealing system which seals the channels of the sterile connector according to the invention so that almost no contamination, in particular no contamination from the environment, can enter the channels.

[0157] In the context of the present invention, the terms "inside, inner, innermost" refer to a component that is related to an outer component and is arranged further inside a sterile connector according to the invention, i.e., closer to a channel. Preferably, an inner component does not come into contact with the surroundings of the sterile connector according to the invention.

[0158] In the context of the present invention, the terms "outside, outer, outermost" refer to a component that is arranged further outward in a sterile connector according to the invention, i.e., closer to a housing arranged peripherally to the interior, relative to an inner component. Preferably, an outer component, in particular its outward-facing surface, comes into contact with the environment of the sterile connector according to the invention. Preferably, in a separated state of a sterile connector according to the invention, contamination is present on an outer component, in particular its outward-facing surface.

[0159] In the context of the present invention, the terms “front, front, frontal” are understood to mean a component that is related to a rear component and is arranged further forward in a sterile connector according to the invention, i.e. closer to an end face.

[0160] In connection with the present invention, the terms “rear, rear, rearer” are understood to mean a component that is related to a front component and is arranged further back in a sterile connector according to the invention, i.e. closer to a connection area.

[0161] In the context of the present invention, the term "separated state" refers to a state of the sterile connector according to the invention in which the socket and plug are not in contact. Preferably, the term "separated state" refers to a state in which no contact surface is formed.

[0162] In the context of the present invention, the term “non-separated state” is understood to mean a plugged-in, a connected or an open state of the sterile connector according to the invention.

[0163] In the context of the present invention, the term "plugged-in state" refers to a state of the sterile connector according to the invention in which the plug head is in the plug receptacle and the end faces of the plug receptacle and the plug head are in full contact with one another, defining a contact surface between the plug receptacle and the plug head, wherein the at least one longitudinally displaceable element of the socket and the plug has not yet undergone any longitudinal displacement relative to the respective at least one channel. Preferably, the end faces of the plug receptacle and the plug head, which are in full contact with one another, are not subjected to any force in the plugged-in state.

[0164] In the context of the present invention, the term “unplugged state” is understood to mean a separated, connected or open state of the sterile connector according to the invention.

[0165] In the context of the present invention, the term "connected state" refers to a state of the sterile connector according to the invention in which the plug head is present in the plug receptacle and the at least one longitudinally displaceable element of the socket and the plug has undergone a longitudinal displacement relative to the respective at least one channel, but no fluid connection has yet been established between a first and a second closed system. In the context of the present invention, the term "unconnected state" refers to a separated, plugged-in, or open state of the sterile connector according to the invention.

[0166] In the context of the present invention, the term “open state” is understood to mean a state of the sterile connector according to the invention in which the plug head is present in the plug receptacle, at least one longitudinally displaceable element of the socket and the plug has undergone a longitudinal displacement relative to the respective at least one channel, and a fluid connection between two closed systems connected to the sterile connector according to the invention is possible.

[0167] In the context of the present invention, the term “non-opened state” is understood to mean a separated, inserted or connected state of the sterile connector according to the invention.

[0168] In the context of the present invention, the term "medium to be transported" refers to a medium that is transported, i.e., transferred, between a first closed system or a second closed system into the other closed system using a sterile connector according to the invention. The medium to be transported preferably comprises a gas or a liquid. The medium to be transported is preferably a gas, a gas mixture, a medium comprising a liquid, in particular a suspension or emulsion, a biologically active medium, or a homogeneous liquid, in particular a liquid consisting of a substance, in particular a biologically compatible liquid.

[0169] In the context of the present invention, the term “biologically active medium” is understood to mean a medium that comprises, in particular consists of, at least one biologically active material, a biologically compatible liquid, a biologically compatible gas, or a combination thereof. A biologically active medium is preferably understood to mean a medium that is endowed with desired chemical and / or biological activities, for example enzymatic, catalytic, or cell-bound activities. A biologically active medium is preferably thermo- or UV-sensitive. A biologically active medium is preferably not a contamination, i.e. not an undesired material, in particular not a biological system, i.e. not a contaminant. The biologically active medium is preferably thermolabile, in particular at a temperature above 37°C.According to the present invention, biologically active media are preferably media to be transferred from a first closed system to a second closed system. Biologically active media are preferably not contaminants originating from the environment of the sterile connector according to the invention.

[0170] Preferably, the biologically active material is selected from the group consisting of animal cells, human cells, plant cells, fungal cells, growth factors, bacteria, viruses, viroids, proteins, peptides, enzymes and combinations thereof.

[0171] The cells are preferably immune cells, especially human immune cells.

[0172] Preferably, the biologically compatible liquid is selected from the group consisting of water, buffer solution, stock solution, saline solution, physiological saline solution, a cell culture medium or cell culture solution and combinations thereof.

[0173] Preferably, the biologically compatible gas is selected from the group consisting of nitrogen, a noble gas, in particular argon, oxygen and carbon dioxide.

[0174] In the context of the present invention, "temperature compatible with a biologically active medium" is understood to mean a temperature at which the biological activity of the biologically active medium is not adversely affected, in particular not impaired. A temperature compatible with a biologically active medium is preferably below 37°C, in particular between 20 and 37°C.

[0175] In the context of the present invention, "biologically active" refers to a chemical and / or biological activity, for example, enzymatic, catalytic, or cell-bound activity, of a medium. Biologically active materials preferably induce a reaction in another biological material, in particular in a living organism. Biologically active materials are preferably incorporated into or converted into another biological material, in particular into a living organism.

[0176] In the context of the present invention, the term "contamination" refers to the presence of undesirable materials originating from the environment, also referred to as contaminants, particularly biological systems, especially microorganisms, for example spores, bacteria, bacilli, fungi, viruses or viroids, RNA or DNA, on a surface of the sterile connector. Contaminants can preferably be removed, in particular killed and / or destroyed, by inductive heating.

[0177] In the context of the present invention, the term "sterile connection" refers to a connection established between two or more closed systems, which allows a medium, in particular a liquid, to be transported between the two systems into the other system. The sterile connection does not alter, or only slightly alters, the closed nature of these systems, so that the systems continue to have no contact with the environment, in particular the non-sterile environment. In a particular embodiment, one or both closed systems can be sterile.

[0178] In the context of the present invention, the term "fluid connection" refers to a connection between two systems that enables a medium to be transported, in particular a liquid, located in one of the two systems to be transported into the other system. A fluid connection between two systems, in particular closed systems, is preferably established as soon as it is possible for media to be transported located in one system to be transported from one system to the other via a sterile connector according to the invention that is in the open state and connected to the two systems.

[0179] In the context of the present invention, the term “inductively heatable” is understood to mean a property of a material which is characterized in that it can be heated by induction to a higher temperature than its initial temperature, in particular to 30 to 1000 °C, in particular 30 to 500 °C, in particular 100 to 180 °C, in particular 160 to 180 °C.

[0180] In the context of the present invention, the term "heatable" refers to a property of a material characterized by the fact that the material is heated by heat transfer from another material at a higher temperature, i.e., it has a higher temperature than before the heat transfer. Preferably, a heatable material cannot be heated inductively.

[0181] In the context of the present invention, the term “heat-resistant” is understood to mean a property of a material which is characterized in that it cannot be heated to a temperature of more than 37 to 100°C, in particular 37°C, in particular 30°C, in particular 25°C, either by inductive heating or by heat transfer from another material having a higher temperature, in particular within 15 minutes. Preferably, a heat-resistant material cannot be heated to a temperature range of 30 to 100°C, in particular 50 to 100°C, in particular 30 to 60°C, within 5 to 30 minutes, in particular 10 to 15 minutes, in particular 15 minutes, in particular by an inductively heated material. Preferably, a heat-resistant material cannot be heated to a temperature of an inductively heated material, in particular by the inductively heated material.

[0182] In the context of the present invention, the term “encapsulation” is understood to mean a fluid-tight enclosure of a component, in particular a spring, or a channel, by adjacent components.

[0183] In the context of the present invention, the term "magnetic star" refers to a system of at least two magnets or a magnet and a magnetic material, which interact in such a way that, upon actuation of the magnetic system, the at least one longitudinally displaceable element is displaced longitudinally. A magnetic system is preferably not a magnetic device.

[0184] In the context of the present invention, the term "magnetic device" refers to a device comprising at least two magnets that interact to form a reset element according to the present invention. A magnetic device preferably has an outer reset magnet and an inner reset magnet, the inner reset magnet being displaceable, in particular longitudinally displaceable. A magnetic device is preferably not a magnetic system.

[0185] In the context of the present invention, the term “at least one” is understood to mean a quantity that expresses a number of 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 and so on. In a particularly preferred embodiment, the designation “at least one” can represent exactly the number 1. In a further preferred embodiment, the term “at least one” can also mean 2 or 3 or 4 or 5 or 6 or 7. If a “presence”, a “containing”, a “having” or a “content” of a component is expressly mentioned or implied in the context of the present invention, this means that the respective component is present, in particular is present in a measurable amount.

[0186] In the context of the present invention, the term "and / or" means that all members of a group linked by the term "and / or" are disclosed both alternatively to one another and cumulatively among one another in any combination. For the expression "A, B, and / or C," this means that the following disclosure content is to be understood: a) A or B or C or b) (A and B), or c) (A and C), or d) (B and C), or e) (A and B and C).

[0187] In the context of the present invention, the terms "comprising" and "having" are understood to mean that, in addition to the elements explicitly covered by these terms, further, not explicitly mentioned elements can be added. In the context of the present invention, these terms are also understood to mean that only the explicitly mentioned elements are covered and no further elements are present. In this particular embodiment, the meaning of the terms "comprising" and "having" is synonymous with the term "consisting of". Furthermore, the terms "comprising" and "having" also encompass compositions which, in addition to the explicitly mentioned elements, also contain further elements not mentioned, which, however, are of a functional and qualitatively subordinate nature. In this embodiment, the terms "comprising" and "having" are synonymous with the term "consisting essentially of".The term “consisting of” means that only the explicitly mentioned elements are present and the presence of further elements is excluded.

[0188] Further embodiments of the present invention are the subject matter of the subclaims and further independent claims.

[0189] The invention is explained in more detail with reference to the following examples and the associated figures.

[0190] The figures show: Figure 1 a first embodiment of a sterile connector according to the invention consisting of a socket (1) and a plug (2) as well as an induction coil (3),

[0191] Figure 2 shows a longitudinal section of a first embodiment of an inventive

[0192] Sterile connector comprising a socket (1) and a plug (2) in a separated state,

[0193] Figure 3 shows a longitudinal section of a first embodiment of an inventive

[0194] Sterile connector comprising a socket (1) and a plug (2) in a plugged-in state,

[0195] Figure 4 shows a longitudinal section of a first embodiment of an inventive

[0196] Sterile connector comprising a socket (1) and a plug (2) in a connected state,

[0197] Figure 5 shows a longitudinal section of a first embodiment of an inventive

[0198] Sterile connector comprising a socket (1) and a plug (2) in an open state,

[0199] Figure 6 a) a second embodiment of a sterile connector according to the invention comprising a socket (102), a plug (103) and a magnet system formed on the socket (102); b) a longitudinal section of a first alternative of the second embodiment of a sterile connector according to the invention comprising a socket (102), a plug (103), a magnet system formed on the socket (102) and an induction coil (104),

[0200] Figure 7 shows a longitudinal section of a first alternative of the second embodiment of a sterile connector according to the invention comprising a socket (102), a plug (103) and a magnet system (101, 111) formed on the socket (102) in a separated state,

[0201] Figure 8 shows a longitudinal section of a second alternative of the second embodiment of a sterile connector according to the invention comprising a socket (102), a plug (103) and a magnet system (101, 111) formed on the socket (102) in a separated state,

[0202] Figure 9 shows a longitudinal section of a first alternative of the second embodiment of a sterile connector according to the invention comprising a socket (102), a plug (103) and a magnet system (101, 111) formed on the socket (102) in a plugged-in state,

[0203] Figure 10 shows a longitudinal section of a first alternative of the second embodiment of a sterile connector according to the invention comprising a socket (102), a plug (103) and a magnet system (101, 111) formed on the socket (102) in an open state, Figure 11 shows a third embodiment of a sterile connector according to the invention comprising a socket (202), a plug (203) and a magnet system (201) formed on the socket (202),

[0204] Figure 12 shows a longitudinal section of the third embodiment of a sterile connector according to the invention comprising a socket (202), a plug (203) and a magnet system (201, 211) formed on the socket (202) in a separated state,

[0205] Figure 13 shows a longitudinal section of the third embodiment in an inserted state,

[0206] Figure 14 shows a longitudinal section of the third embodiment in an open state,

[0207] Figure 15 shows a fourth embodiment of a sterile connector according to the invention comprising a socket (302), a plug (303) and a magnet system (301) formed on the socket (302),

[0208] Figure 16 is a longitudinal section of the fourth embodiment in a separated state,

[0209] Figure 17 shows a longitudinal section of the third embodiment in an inserted state,

[0210] Figure 18 shows a longitudinal section of the fourth embodiment in an open state, and Figure 19 shows a cross section of a plunger of the fourth embodiment of a sterile connector according to the invention.

[0211] LIST OF REFERENCE SYMBOLS

[0212] A Connection area of ​​the socket

[0213] B channel of the socket

[0214] C Channel of the connector

[0215] D Connection area of ​​the plug

[0216] 1 socket

[0217] 2 plugs

[0218] 3 Induction coil

[0219] 4 Connection component of the socket

[0220] 5 socket housings

[0221] 6 Outer return spring of the bushing

[0222] 7 plungers

[0223] 8 Front ring of the socket

[0224] 9 Inner seal of the front ring of the socket

[0225] 10 Outer seal of the front ring of the socket

[0226] 11 Rear seal of the connector receptacle

[0227] 12 Front seal of the connector receptacle

[0228] 13 Inner return spring of the bushing

[0229] 14 channel component of the socket

[0230] 15 Tappet seal

[0231] 16 Sealing ring of the bushing channel

[0232] 17 Front panel of the socket

[0233] 18 Front panel of the connector

[0234] 19 Front seal of the connector

[0235] 20 Front cover of the connector

[0236] 21 Connecting channel component

[0237] 22 Inner seal of the connector

[0238] 23 connector housings

[0239] 24 Plug mounting cover

[0240] 25 sealing grommet

[0241] 26 channel component of the connector

[0242] 27 Connector return spring

[0243] 28 Rear seal of the connector 9 Connection component of the connector

[0244] 101 Ring magnet

[0245] 102 socket

[0246] 103 plugs

[0247] 104 Induction coil

[0248] 105 Connection component of the socket

[0249] 106 Magnetic cover of the socket

[0250] 107 Bushing tappet

[0251] 108 socket housings

[0252] 109 Front panel of the socket

[0253] 110 Sterilization sleeve of the socket

[0254] 111 Inner magnet of the socket

[0255] 112 Bushing tappet holder

[0256] 113 Bushing return spring

[0257] 114 Bushing sealing ring

[0258] 115 Front panel of the connector

[0259] 116 Front housing part of the connector

[0260] 117 Inner seal of the connector

[0261] 118 Outer seal of the connector

[0262] 119 Plug plunger

[0263] 120 Connector return spring

[0264] 121 Connection component of the plug

[0265] 201 Ring magnet

[0266] 202 socket

[0267] 203 plugs

[0268] 204 Induction coil - not shown -

[0269] 206 Magnetic cover of the socket

[0270] 207 Bushing tappet

[0271] 208 socket housing

[0272] 209 Front panel of the socket

[0273] 210 Sterilization sleeve of the socket

[0274] 211 Inner magnet of the socket

[0275] 213 Bushing return spring

[0276] 214 Sealing ring of the socket 215 Front panel of the plug

[0277] 216 Front housing part of the connector

[0278] 217 Inner seal of the connector

[0279] 218 Outer seal of the connector

[0280] 219 Plug plunger

[0281] 220 Connector return spring

[0282] 221 Connection component of the plug

[0283] 301 ring magnet

[0284] 302 socket

[0285] 303 plug

[0286] 304 Induction coil - not shown -

[0287] 306 Magnetic cover of the socket

[0288] 307 Bushing tappet

[0289] 308 socket housing

[0290] 309 Front panel of the socket

[0291] 310 Sterilization sleeve of the socket

[0292] 311 Inner magnet of the socket

[0293] 314 Bushing sealing ring

[0294] 315 Front panel of the connector

[0295] 316 Front housing part of the connector

[0296] 317 Inner seal of the connector

[0297] 318 Outer seal of the connector

[0298] 319 Plug plunger

[0299] 323 connector housing

[0300] 330 spacers for the inner magnets

[0301] 331 Inner return magnet of the bushing

[0302] 332 Outer return magnet of the socket

[0303] 333 Internal reset magnet of the connector

[0304] 334 Connecting element between the plug plunger (319) and the front panel of the plug

[0305] (315)

[0306] 335 Outer reset magnet of the connector Example 1

[0307] Figure 1 shows an external view of a first embodiment of a sterile connector according to the invention, comprising a socket (1) and a plug (2), as well as an induction coil (3). The socket (1) and the induction coil (3) are shown separately on the left side of Figure 1, and the plug (2) is shown separately on the right side of Figure 1, i.e., in a separated state of the sterile connector according to the invention. The induction coil (3) encloses a tapered part of the socket (1) located closer to the plug. For the sterilization process, the socket and plug are guided into the interior of a coil (3), and the plug head of the plug is pushed into the plug receptacle of the socket until the respective end faces are in full contact, whereby the sterile connector according to the invention is thus in a plugged-in state.

[0308] Figures 2 to 5 show a first embodiment of a sterile connector (1) according to the invention, comprising a socket (1) and a plug (2), in longitudinal section. Figure 2 shows a first embodiment of a sterile connector according to the invention in a disconnected state. Figure 3 shows a first embodiment of a sterile connector according to the invention in a plugged-in state. Figure 4 shows a first embodiment of a sterile connector according to the invention in a connected state. Figure 5 shows a first embodiment of a sterile connector according to the invention in an open state. The individual components of the first embodiment of a sterile connector according to the invention and their function, as well as a method according to the invention using a first embodiment of the sterile connector according to the invention, are described below with reference to Figures 2 to 5.

[0309] The socket (1) has a connection area (A) to a first or second closed system and a plug receptacle configured to receive a plug head. A first or second closed system, such as a hose from which liquid is to be transported or into which liquid is to be transported, can be connected to the connection area (A). The connection area (A) is preferably designed as a core hole for gluing in a Luer-Lock connector for connecting a syringe or a corresponding piece of tubing. The connection area (A) is formed by a connection component of the socket (4). Preferably, the connection component of the socket (4) is glued into a socket housing (5), or the connection component of the socket (4) and a first part of the socket housing (5) are configured from one component, wherein the socket housing (5) then consists of two parts.The plug receptacle has side wall surfaces formed by three components, namely the socket housing (5), a rear seal of the socket (11), and a front seal of the socket (12), and a socket end face formed by two components, namely a front ring of the socket (8) and a front plate of the socket (17). The socket housing (5) contains all components of the socket. The front ring of the socket (8) and the front plate of the socket (17) are made of an inductively heatable material.

[0310] Furthermore, the socket has a channel (B) extending from the connection area (A) of the socket to the plug receptacle. The channel (B) of the socket is formed by a channel component (14), the connection component (4), and a plunger (7). The medium to be transported is guided through the socket through the channel (B) (Figure 5).

[0311] The plug (2) has a connection area (D) for the first or second closed system and a plug head configured for insertion into the plug receptacle. A first or second closed system, such as a hose from which liquid is to be transported or into which liquid is to be transported, can be connected to the connection area (D). The connection area (D) is preferably designed as a core hole for gluing in a Luer-Lock connector for connecting a syringe or a corresponding piece of hose. The connection area (D) is formed by a connection component of the plug (29). The plug head has side wall surfaces formed by two components, namely a front cover of the plug (20) and a connecting channel component (21), and an end face of the plug head formed by two components, namely a front plate of the plug (18) and a front cover of the plug (20).The front panel of the plug (18) is made of inductively heatable material. The front cover of the plug (20) is made of inductively heatable material and, while heated when plugged in, sterilizes the inner wall of the socket in the plug receptacle (Figure 3). The connecting channel component (21) is pushed into the interior of the socket before the sterile connector according to the invention is opened and, along with other components there, enables the transition of a medium to be transported from a first or second closed system to the other between the plug and socket of the sterile connector according to the invention (Figures 4 and 5). Furthermore, the plug (2) has a channel (C) running from the connection area (D) of the plug to the plug head.The channel (C) of the plug is formed by a channel component (26) and the connection component of the plug (29) and is made of a heat-resistant material. The medium to be transported is guided through the channel (C) through the plug (Figure 5). The channels of the socket and the plug (B, C) each have a reversible channel closure system in the front area of ​​the respective channel, namely a plunger (7) for the socket and a connecting channel component (21) for the plug. The plunger (7) is functionally connected to two return elements, namely an outer return spring of the socket (6) and an inner return spring of the socket (13). The plunger closes the channel (B) when the sterile connector according to the invention is not opened by being pressed against a sealing ring of the channel (16) by the inner return spring of the socket (13) in the non-opened state (Figures 2 to 4).The connecting channel component (21) is functionally connected to a return element, namely a return spring of the plug (27). The connecting channel component (21) is pushed into the interior of the socket before the channel closure system according to the invention is opened and, along with other components therein, enables the transition from a medium to be transported in a first or second closed system to the other between the plug and socket in the open state of the sterile connector according to the invention (Figure 5).

[0312] The outer and inner return springs of the socket (6, 13) are functionally connected to four elements that are longitudinally displaceable relative to the channel (B), namely the tappet (7), the front ring of the socket (8), an inner seal of the front ring of the socket (9), and a seal of the tappet (15). The return spring of the plug (27) is functionally connected to seven longitudinally displaceable elements, namely a front seal of the plug (19), the front shell of the plug (20), the connecting channel component (21), an inner seal of the plug (22), a plug housing (23), a mounting cover of the plug (24), and a rear seal of the plug (28).

[0313] The outer return spring of the socket (6) presses the front ring of the socket (8) against the socket housing (5). The outer return spring of the socket (6) is compressed by the front ring of the socket (8) when the longitudinally displaceable elements, in particular the front cover of the plug (20), of the plug are inserted into the socket (Figures 4 and 5). During the final part of this compression of the outer return spring of the socket (6), the front ring of the socket (8) is pressed against the plunger (7), and the plunger (7) is displaced toward the connection area of ​​the socket (A), whereby the sterile connector according to the invention is in an open state (Figure 5).

[0314] The inner return spring of the socket (13) presses the plunger (7) against a sealing ring of the channel of the socket (16), thereby sealing the channel (B) and ensuring that the sterile connector according to the invention is in a non-open state. By displacing the front ring of the socket (8) toward the connection area of ​​the socket (A), the plunger (7) compresses the inner return spring of the socket (13) until the sterile connector according to the invention is in the open state (Figures 4 and 5). In the separated state, the sealing ring (16) prevents fluids from entering the channel (B) between the plunger (7) and the front plate of the socket (17).

[0315] The return spring of the plug (27) enables the front seal of the plug (19), the front cover of the plug (20), the connection channel component (21), the inner seal of the plug (22), the plug housing (23), the mounting cover of the plug (24), and a rear seal of the plug (28) to be pushed back into their original position after the relative movement in the direction of the connection area (A) of the socket, thus closing the plug (2) again, i.e. the sterile connector according to the invention is in a non-open state. The plug housing (23) forms the outer shell of the right-hand part of the plug, which is located on the left side in Figure 2, relative to the plug head. The mounting cover of the plug (24) is glued into the plug housing (23) after all of the plug components located inside the plug have been installed.The rear seal of the connector (28) seals the interior of the connector mounting cover (24) against the interior of a foldable sealing grommet (25) and serves to guide the movement of the connector connection component (29) into the connector mounting cover (24). The foldable sealing grommet (25) is made of a flexible material and prevents contaminants from entering the interior of the connector (2) during movement from the connector connection component (29) into the connector mounting cover (24).

[0316] The first embodiment of the sterile connector according to the invention also has a contact surface sealing system designed to seal the surfaces defining the contact surface, namely the rear seal of the plug receptacle (11), the front seal of the plug receptacle (12), and a channel sealing system designed to seal the channel (B) of the socket and the channel (C) of the plug, namely, with regard to the socket, a seal of the plunger (15) and the sealing ring of the channel (16), and with regard to the plug, the front seal of the plug (19) and the inner seal of the plug (22). The rear seal of the plug receptacle (11), in combination with the front seal of the plug receptacle (12), prevents contamination from reaching the sterilized surfaces after sterilization.The seal of the plunger (15) prevents fluid from penetrating the interior of the socket housing (5) from the channel (B) between the plunger (7) and the channel component (14) when the sterile connector according to the invention is not opened. The sealing ring of the channel of the socket (16) prevents fluid from penetrating the environment from the channel (B) between the plunger (7) and the channel component (14) when the sterile connector according to the invention is not opened, and prevents contamination from penetrating the interior of the channel (B) when the sterile connector according to the invention is disconnected and / or inserted, particularly prior to sterilization.The front seal of the plug (19) prevents liquid from escaping from the channel (C) into the environment when the sterile connector according to the invention is separated and / or inserted between the front panel of the plug (18) and the front cover of the plug (20), and prevents contaminants from the environment from entering the interior of the channel (C). The inner seal of the plug (22) prevents liquid from entering the interior of the connecting channel component (21) of the plug housing (23). A further seal of the socket is the inner seal of the front ring of the socket (9), which prevents contaminants from entering the interior of the socket housing (5) between the plunger (7) and the front ring of the socket (8) when the sterile connector according to the invention is separated and / or inserted, in particular before sterilization.

[0317] Furthermore, the socket has an outer seal of the front ring of the socket (10), which prevents contamination between the socket housing (5) and the front ring of the socket (8) from entering the interior of the socket housing of the (5) in the separated and / or plugged-in state, in particular before sterilization, of the sterile connector according to the invention.

[0318] Figures 2 to 5 show a method according to the invention for sterilely connecting a first closed system to a second closed system with a first embodiment of the sterile connector according to the invention.

[0319] In a first method step a), a first and a second closed system are provided, wherein these are reversibly or integrally connected in each case to the connection regions of a socket (A) or a plug (D) of a sterile connector according to the invention according to a first embodiment, and an induction coil for inductive heating. The sterile connector according to the invention is in a separated state according to Figure 2. Subsequently, in a method step b), the socket (1) and the plug (2) of the at least one sterile connector are brought together in the plugged-in state of the sterile connector according to the invention according to Figure 3. In this process, the plug head of the plug is pushed far enough into the plug receptacle of the socket that the end faces of the plug and socket lie against one another over their entire surface and define a contact surface of the plug receptacle and the plug head.The components forming the end face of the socket are the front ring of the socket (8) and the front plate of the socket (17), and the components forming the end face of the plug are the front plate of the plug (18) and the front shell of the plug (20). Some of the components (8, 17, 18, 20) defining the contact surface of the plug receptacle and the plug head are inductively heated, or they are completely inductively heated. If only one part is inductively heated, the other part of the components (8, 17, 18, 20) defining the contact surface of the plug receptacle and the plug head is heated, in such a way that the entire surfaces defining the contact surface are heatable. When the plug head is pushed into the plug receptacle, the plug is held by the connection component of the plug (29).

[0320] In a process step c), the sterile connector according to the invention is inductively heated. The induction coil, which surrounds the inductively heatable components (8, 17, 18, 20) of the socket and plug outside the socket (1) and plug (2) in the plugged-in state, is energized. The magnetic field inside the induction coil heats the inductively heatable part of the components (8,

[0321] 17, 18, 20) and by means of a heat transfer between the inductively heatable part and the heatable part of the fully abutting surfaces of the components (8, 17, 18, 20), the heatable part of the components (8, 17, 18, 20) is heated to a temperature and for a time sufficient to sterilize the surfaces defining the contact surface, i.e. to remove possible contaminations on the surface of the components (8, 17,

[0322] 18, 20) of the socket and plug are biologically neutralized. Once the temperature and time have been reached, the power is switched off. Preferably, the required temperature is maintained for the required time. Preferably, the heated components are then allowed to cool down to a temperature at which the medium to be transferred is stable, meaning it will not be damaged.

[0323] Thereafter, in a method step d), the channel closure systems (7, 21) of the socket and the plug of the at least one sterile connector are opened, whereby a fluid connection is established between the first and second closed systems through the at least one sterile connector.

[0324] When opening the channel closure systems according to process step d), the longitudinally movable elements of the plug are pushed into the socket. The sterile connector is in a connected state. In the final part of this movement, the respective channels of the socket and plug are fully opened, and the sterile connector according to the invention is in an open state.

[0325] For the connected state of the sterile connector according to the invention, the plug is held on the plug housing (23) or the mounting cover of the plug (24) and the longitudinally displaceable elements of the plug and the socket are pushed into the socket (Figure 4). In this process, the components (7), (8), (9), (15), (19), (20), (21), (22), (23), (24) and (28) are moved with respect to the respective channels in the direction of the at least one connection area (A) of the socket. In this process, the return elements (6) and (27) designed as springs are compressed. The elastic sealing grommet (25) is stretched.

[0326] During the final part of this movement, the front ring of the socket (8) strikes the plunger (7) and also moves it in the direction of the at least one connection area (A) of the socket. In the process, the return element (13) designed as a spring is also compressed. As a result of this movement, the plunger (7) is pulled away from the sealing ring of the channel of the socket (16) and the channel (B) and the channel (C) are opened, so that the sterile connector according to the invention is in an open state. The liquid can then flow along the dashed line through the sterile connector according to the invention from a first or second closed system into the other closed system, as shown in Figure 5.

[0327] Disconnection is carried out in the reverse order of the steps described, but without the heating step.

[0328] Preferably, the transported medium, in particular the transported liquid, has no contact with the return elements of the sterile connector according to the invention, whereby the sterile connector according to the invention can be cleaned after use by simply rinsing.

[0329] Example 2

[0330] Figure 6 a) shows an external view of a second embodiment of a sterile connector according to the invention, comprising a socket (102), a plug (103), and a magnet (101). The socket (102) and the magnet (101) are shown separated from one another on the left side of Figure 6 a), and the plug (103) is shown on the right side of Figure 6 a), i.e., in a separated state of the sterile connector according to the invention. The magnet is located on the left side of a tapered part of the socket. Figure 6 b) shows a longitudinal cross-section of the socket and the plug of the second embodiment, as well as an induction coil (104). The non-tapered part of the socket, i.e., the wider part, namely a plug receptacle, and a front part of a tapered part, namely a plug head, of the plug, are located within the induction coil (104).For the sterilization process, the plug receptacle of the socket and the plug head of the plug are guided into the interior of the coil (104), the plug head of the plug being pushed into the plug receptacle of the socket until the respective end surfaces lie against one another over their entire surface, whereby the sterile connector according to the invention is thus in a plugged-in state.

[0331] Figures 7 and 8 show a first and a second alternative of a second embodiment of the sterile connector according to the invention comprising a socket (102) on the left and a plug (103) on the right next to each other in a separated state of the sterile connector according to the invention in longitudinal section.

[0332] Figure 9 shows the first alternative of the second embodiment of the sterile connector according to the invention in a plugged-in state. Figure 10 shows the first alternative of the second embodiment of the sterile connector according to the invention in an open state. The individual components of the second embodiment of a sterile connector according to the invention and their function, as well as a method according to the invention using a first alternative of a second embodiment of the sterile connector according to the invention, are described below with reference to Figures 7 to 10.

[0333] The socket (102) has a connection area (A) to the first or second closed system and a plug receptacle configured to receive a plug head. A first or second closed system, such as a hose from which liquid is to be transported or into which liquid is to be transported, can be connected to the connection area (A). The connection area (A) is preferably designed as a core hole for the adhesive insertion of a Luer-Lock connector for connecting a syringe or a corresponding piece of tubing. The connection area (A) is formed by a connection component of the socket (105). Preferably, the connection component of the socket (105) is adhesively bonded to a socket housing (108), or the connection component of the socket (105) and a first part of the socket housing (108) are configured from one component, wherein the socket housing (105) then consists of two parts.The plug receptacle of the first alternative according to Figure 7 has side wall surfaces formed by one component, namely the sterilization sleeve of the socket (HO), and one end face of the socket formed by two components, namely a front panel of the socket (109) and the sterilization sleeve of the socket (110). The plug receptacle of the second alternative according to Figure 8 has side wall surfaces formed by one component, namely the socket housing (108), and one end face of the socket formed by two components, namely the front panel of the socket (109) and the sterilization sleeve of the socket (110). The socket housing (108) is made of heat-resistant material. The front panel of the socket (109) and the sterilization sleeve of the socket (110) are each made of an inductively heatable material.

[0334] Furthermore, the socket has a channel (B) extending from the connection area (A) of the socket to the plug receptacle. The channel (B) of the socket is formed by the connection component of the socket (105) and the socket housing (108). The front panel of the socket (109) closes the channel (B). When the sterile connector according to the invention is open, the medium to be transported is guided through the socket through the channel (B) (Figure 10).

[0335] The connector (103) has a connection area (D) for the first or second closed system and a connector head configured for insertion into the connector receptacle. A first or second closed system, such as a tube from which liquid is to be transported or into which liquid is to be transported, can be connected to the connection area (D). The connection area (D) is preferably designed as a core hole for gluing in a Luer-Lock connector for connecting a syringe or a corresponding piece of tubing. The connection area (D) is formed by a connection component of the connector (121), which is also a rear housing part of the connector.In the first alternative according to Figure 7, the plug head has side wall surfaces formed by two components, namely a front housing part of the plug (116) and an outer seal of the plug (118), and an end face of the plug head formed by two components, namely a front plate of the plug (115) and the front housing part of the plug (116). In the second alternative according to Figure 8, the plug head has side wall surfaces formed by one component, namely the front housing part of the plug (116), and an end face of the plug head formed by three components, namely the front plate of the plug (115), the outer seal of the plug (118), and the front housing part of the plug (116). The front plate of the plug (115) is made of inductively heatable material. The front housing part of the plug (116) and the outer seal of the plug (118) are made of heatable material.The outer seal of the plug (118) prevents contamination between the sterilization sleeve of the socket (110) and the front housing part of the plug (116) from entering the interior of the sterile connector according to the invention when plugged in and after heating the sterile connector according to the invention. The housing of the plug therefore consists of four parts: the front housing part of the plug (116), which, together with the front panel of the plug (115) and the outer seal of the plug (118), forms the plug head and the front part of the plug housing, and a rear housing part of the plug, namely the connection component of the plug (121).

[0336] In Figure 7, i.e., the first alternative of the second embodiment, both the components forming the end faces and side wall surfaces of the plug receptacle of the socket (109, 110) and one of two components forming the end face of the plug head (115) are made of an inductively heatable material. The components forming the side wall surfaces of the plug head (116, 118), however, are made of a heatable material. When the surfaces of the end faces and side wall surfaces of the plug receptacle and the plug head are in full contact with one another, a contact surface is defined.The outer seal of the plug (118) is positioned on the surface of one of the components forming the side wall surfaces of the plug head (116), in particular at the transition from the respective side wall surface to the end surface, in such a way that when the components are in full contact with one another, in particular when not separated, at least part of the contact surface, in particular the entire contact surface defined by the end surfaces and side wall surfaces is peripherally enclosed on all sides by the outer seal of the plug (118) and no undesired material, i.e. no contamination, reaches the surfaces to be heated, i.e. sterilized, enclosed by the outer seal of the plug (118).In such an embodiment, i.e. if at least of either the plug receptacle or the plug head, the surfaces of the components forming the end face and side wall surfaces and of the respective other the surface of the components forming the end face have or consist of inductively heatable or heatable materials, a seal, in particular an annular seal, on the surfaces of the components forming the side wall surfaces, in particular on at least part of the part of the surfaces defining the contact surface, in particular at the transition from the respective side wall surface to the end face, is helpful, in particular necessary, in order to prevent the penetration into the interior, in particular into the channel, of the sterile connector according to the invention of undesired materials, in particular contamination, in particular after the sterilization step.

[0337] In Figure 8, the second alternative of the second embodiment, both the components forming the end faces of the plug receptacle of the socket (109, 110) and one of the three components forming the end face of the plug head (115) are made of an inductively heatable material. The other two of the three components forming the end face of the plug head (116, 118) are made of a heatable material. The component forming the side wall surfaces of the plug receptacle (108) is made of a heat-resistant material. When the inductively heatable or heatable surfaces of the end faces of the plug receptacle and the plug head are in full contact with one another, a contact surface is defined. The outer seal of the plug (118) is positioned on the surface of the one component forming the end face of the plug receptacle (116) in such a way thatin particular at the transition between the one inductively heatable or heatable component (115) forming the end face of the plug head and the other inductively heatable or heatable component (116) forming the end face of the plug head, such that when they are in full contact with one another, in particular in the non-separated state, at least a part of the, in particular the entire, contact surface defined by the end faces is peripherally enclosed on all sides by the outer seal of the plug (118), namely in particular at least the part that is also formed from longitudinally displaceable elements, and no undesired material, i.e. no contamination, reaches the surfaces to be heated, i.e. sterilized, enclosed by the outer seal of the plug (118), in particular the front panels of the socket (109) and the plug (115). In such an embodiment,Thus, if the surfaces of the components forming the end faces of the connector receptacle and the connector head comprise or consist of inductively heatable or heatable materials, a seal, in particular an annular seal, on the surfaces of the components forming the end face, in particular on at least part of the part of the surfaces defining the contact surface, in particular at the transition from the part that is also longitudinally displaceable to the part of the components forming the end face that is not also longitudinally displaceable, is helpful, in particular necessary, in order to prevent the penetration into the interior, in particular into the channel, of the sterile connector according to the invention of undesirable materials, in particular contamination, especially after the sterilization step.

[0338] Furthermore, the plug (103) has a channel (C) running from the connection area (D) of the plug to the plug head. The channel (C) of the plug is formed by the front housing part of the plug (116) and the connection component of the plug (121). The front plate of the plug (115) closes the channel (C). The medium to be transported is guided through the plug via the channel (C) (Figure 10). The channels of the socket and the plug (B, C) each have a reversible channel closure system in the front area of ​​the respective channel, namely the front plate of the socket (109) and a sealing ring of the socket (114) with regard to the socket, and the front plate of the plug (115) and an inner seal of the plug (117) with regard to the plug.The sealing ring of the socket (114) is made of heatable material and, when the sterile connector according to the invention is not opened, prevents contamination from entering the interior of the socket between the socket housing (108) and the front panel of the socket (109). Furthermore, the sealing ring of the socket (114) is designed such that, when the sterile connector according to the invention is not opened, it is in contact with both the socket housing (108) and the sterilization sleeve of the socket (110). This ensures that all potentially contaminated areas are heated, while at the same time any liquid present in the connector does not come into contact with the inductively heated sterilization sleeve of the socket (110).The inner seal of the plug (117) is made of heatable material and prevents impurities from entering the interior of the plug between the front housing part of the plug (116) and the front panel of the plug (115) when the sterile connector according to the invention is not opened.

[0339] The reversible channel closure system of the socket (109, 114) is functionally connected to a return element, namely a return spring of the socket (113). The reversible channel closure system of the plug (115, 117) is functionally connected to a return element, namely a return spring of the plug (120).

[0340] The return spring of the socket (113) is functionally connected to six elements that are longitudinally displaceable relative to the channel (B), namely a magnet cover of the socket (106), a plunger of the socket (107), the front plate of the socket (109), an internal magnet of the socket (111), a plunger holder of the socket (112), and the sealing ring of the socket (114). The return spring of the plug (120) is functionally connected to three longitudinally displaceable elements, namely the front plate of the plug (115), the internal seal of the plug (117), and a plunger of the plug (119).

[0341] When the sterile connector according to the invention is not opened, the return spring of the socket (113) presses the plunger holder of the socket (112) relative to the channel (B) toward the connection area (A) of the socket. This presses the sealing ring of the socket (114) against the socket housing (108) (Figures 7 and 8). The plunger holder of the socket (112) serves to connect the plunger of the socket (107) and the internal magnet of the socket (111). The plunger of the socket (107) is made of heat-resistant material and is indirectly moved by the internal magnet of the socket (111). The magnet cover of the socket (106) prevents the medium to be transported from coming into contact with the internal magnet of the socket (111). The magnet cover of the socket (106) is optional if the internal magnet of the socket (111) is compatible with the medium to be transported.

[0342] In a non-opened state of the sterile connector according to the invention, the return spring of the plug (120) presses the plunger of the plug (119), which consists of heat-resistant material, with the inner seal of the plug (117) with respect to the channel (D) in the direction of the end face of the plug against the front housing part of the plug (116) (Figures 7 and 8).

[0343] The second embodiment of the sterile connector according to the invention also has a magnet system formed on the socket (102) consisting of a ring magnet (101) and the inner magnet of the socket (111) (Figures 7 to 10). The ring magnet (101) is formed on the outside of the socket, and the inner magnet of the socket (111) is formed inside the socket, both being formed at the same height of the longitudinal axis of the socket on the connection area side to the remaining longitudinally displaceable elements (106, 107, 109, 112, 114). The ring magnet (101) moves the inner magnet of the socket (111) inside the socket. This displaces the remaining longitudinally displaceable elements of the socket (106, 107, 109, 112, 114).In the plugged-in state of the sterile connector according to the invention, the displacement of the magnet system (101, 111) toward the connection area of ​​the plug (D) causes the remaining longitudinally displaceable elements of the socket and the longitudinally displaceable elements of the plug to also be displaced toward the connection area of ​​the plug (D), and the respective spring system of the socket and plug is compressed. As a result, the respective channel closure system of the socket and plug no longer closes the socket and plug, and a fluid connection is established between the first and second closed systems. The sterile connector according to the invention is in an open state.

[0344] Furthermore, the second embodiment comprises a contact surface sealing system designed to seal the surfaces defining the contact surface, namely the outer seal of the plug (118), and a channel sealing system designed to seal the channel (B) of the socket and the channel (C) of the plug, namely, with regard to the socket, the sealing ring of the socket (114) and, with regard to the plug, the inner seal of the plug (117). Figures 7, 9, and 10 show a method according to the invention for sterilely connecting a first closed system to a second closed system using the first alternative of a second embodiment of the sterile connector according to the invention.

[0345] In a first method step a), a first and a second closed system are provided, each of which is reversibly or integrally connected to the connection areas of a socket (A) or a plug (D) of a sterile connector according to the invention according to the first alternative of the second embodiment, and an induction coil for inductive heating is provided. The sterile connector according to the invention is in a separated state according to Figure 7. Subsequently, in a method step b), the socket (102) and the plug (103) of the at least one sterile connector are brought together in the plugged-in state according to Figure 9. The plug head of the plug is pushed into the plug receptacle of the socket until the end faces of the plug and socket lie against one another over their entire surface and define a contact surface of the plug receptacle and the plug head.The components forming the end face of the socket are the front panel of the socket (109) and the sterilization sleeve of the socket (110), and the components forming the end face of the plug are the front panel of the plug (115), the front housing part of the plug (116), and optionally the outer seal of the plug (118). Some of the components (109, 110, 115, 116) defining the contact surface of the socket and the plug are inductively heatable, or they are completely inductively heatable. If only one part is inductively heatable, the other part of the components (109, 110, 115, 116) defining the contact surface of the plug receptacle and the plug head is heatable, such that the entire surfaces defining the contact surface are heatable.

[0346] In a process step c), the sterile connector according to the invention is inductively heated. The induction coil, which surrounds the inductively heatable part of the components (109, 110, 115, 116) of the socket and plug outside the socket (102) and plug (103) in the plugged-in state, is energized. The magnetic field inside the induction coil heats the inductively heatable part of the components (109, 110, 115, 116) and the heatable part of the fully abutting surfaces of the components (109, 110, 115, 116) to a temperature and for a time sufficient to sterilize the surfaces defining the contact surface, i.e. to render biologically harmless any possible contamination on the components (109, 110, 115, 116) of the socket and plug forming the surface defining the contact surface.Once the temperature and time are reached, the power is turned off. It is then preferable to wait until the heated components have cooled down to a temperature at which the medium being transferred is stable and will not be damaged.

[0347] Thereafter, in a method step d), the channel closure systems (109, 114, 115, 117) of the plug and the socket of the at least one sterile connector are opened, whereby a fluid connection is established between the first and second closed systems through the at least one sterile connector.

[0348] When the channel closure systems are opened according to process step d), the longitudinally displaceable components of the socket and plug are pushed toward the connection area of ​​the plug (D) (Figure 10) by means of the magnet system (101, 111). The sterile connector according to the invention is in an open state.

[0349] The components (106), (107), (109), (112), (114), (115), (117), and (119) are moved relative to the respective channels of the socket and plug in the direction of at least one connection area (D) of the plug using the magnetic system (101, 111). In this process, the return elements (113) and (120), designed as springs, are compressed.

[0350] This movement pushes the sealing ring of the socket (114) away from the socket housing (108) and simultaneously pushes the inner seal of the plug (117) away from the front housing part of the plug (116), opening the channels (B, C) so that the sterile connector according to the invention is in an open state. According to Figure 10, the fluid can flow along the dashed line through the sterile connector according to the invention from a first or second closed system into the other closed system.

[0351] Disconnection is carried out in the reverse order of the steps described, but without the heating step.

[0352] Example 3

[0353] Figure 11 shows an external view of a third embodiment of a sterile connector according to the invention, comprising a socket (202), a plug (203), and a ring magnet (201). The socket (202) and the ring magnet (201) are shown on the left side of Figure 11, and the plug (203) is shown on the right side, separated from one another, i.e., in a separated state of the sterile connector according to the invention. The ring magnet is located on the left side of the socket.

[0354] In Figure 12, the third embodiment of the sterile connector according to the invention comprising a socket (202) on the left and a plug (203) on the right next to each other in a separated state of the sterile connector according to the invention is shown in longitudinal section.

[0355] Figure 13 shows the third embodiment of the sterile connector according to the invention in a plugged-in state. Figure 14 shows the third embodiment of the sterile connector according to the invention in an open state. The individual components of the third embodiment of a sterile connector according to the invention and their function, as well as a method according to the invention using the third embodiment of the sterile connector according to the invention, are described below with reference to Figures 11 to 14.

[0356] In Figure 12, both the components forming the end faces and side wall surfaces of the plug receptacle of the socket (209, 210) and one of two components forming the end face of the plug head (215) are made of an inductively heatable material. The components forming the side wall surfaces of the plug head (216, 218), however, are made of a heatable material. When the surfaces of the end faces and side wall surfaces of the plug receptacle and the plug head are in full contact with one another, a contact surface is defined.The outer seal of the plug (218) is positioned on the surface of one of the components forming the side wall surfaces of the plug head (216), in particular at the obliquely designed transition from the respective side wall surface to the end surface, such that when the two components are in full contact with one another, in particular when not separated, at least part of the contact surface, in particular the entire contact surface defined by the end surfaces and side wall surfaces is peripherally enclosed on all sides by the outer seal of the plug (218) and no undesired material, i.e. no contamination, reaches the surfaces to be heated, i.e. sterilized, enclosed by the outer seal of the plug (218).In such an embodiment, i.e. if at least of either the plug receptacle or the plug head, the surfaces of the components forming the end face and side wall surfaces and of the respective other the surface of the components forming the end face have or consist of inductively heatable or heatable materials, a seal, in particular an annular seal, on the surfaces of the components forming the side wall surfaces, in particular on at least part of the part of the surfaces defining the contact surface, in particular at the transition from the respective side wall surface to the end face, is helpful, in particular necessary, in order to prevent the penetration into the interior, in particular into the channel, of the sterile connector according to the invention of undesired materials, in particular contamination, in particular after the sterilization step.

[0357] Furthermore, the plug (203) has an encapsulated channel (C) extending from the connection area (D) of the plug to the plug head. The channel (C) of the plug is formed by the front housing part of the plug (216) and the plunger of the plug (219).

[0358] The front panel of the connector (215) closes the channel (C). The medium to be transported is guided through the channel (C) through the connector (Figure 14).

[0359] The channels of the socket and the plug (B, C) each have a reversible channel closure system in the front area of ​​the respective channel, namely the front plate of the socket (209) and a sealing ring of the socket (214) with respect to the socket, and the front plate of the plug (215) and an inner seal of the plug (217) with respect to the plug. The sealing ring of the socket (214) is made of heatable material and prevents contamination between the socket housing (208) and the front plate of the socket (209) from entering the interior of the socket when the sterile connector according to the invention is not opened. The inner seal of the plug (217) is made of heatable material and prevents contamination between the front housing part of the plug (216) and the front plate of the plug (215) from entering the interior of the plug when the sterile connector according to the invention is not opened.

[0360] The reversible channel closure system of the socket (209, 214) is functionally connected to a return element, namely a return spring of the socket (213). The reversible channel closure system of the plug (215, 217) is functionally connected to a return element, namely a return spring of the plug (220). The return spring of the socket (213) and the return spring of the plug (220) are encapsulated, in particular enclosed by an encapsulation. This preferably ensures that fewer deposits accumulate in the socket and / or the plug, in particular on the respective return springs (213, 220), especially when the sterile connector according to the invention is used multiple times.

[0361] The return spring of the socket (213) is functionally connected to five elements that are longitudinally displaceable relative to the channel (B), namely a magnetic cover of the socket (206), a plunger of the socket (207), the front plate of the socket (209), an internal magnet of the socket (211), and the sealing ring of the socket (214). The return spring of the plug (220) is functionally connected to three longitudinally displaceable elements, namely the front plate of the plug (215), the internal seal of the plug (217), and a plunger of the plug (219).

[0362] When the sterile connector according to the invention is not opened, the return spring of the socket (213) presses the functionally connected, longitudinally displaceable elements relative to the channel (B) toward the connection area (A) of the socket. This presses the sealing ring of the socket (214) against the sterilization sleeve of the socket (210) (Figure 12). The magnet cover of the socket (206) serves to connect the plunger of the socket (207) and the inner magnet of the socket (211). The plunger of the socket (207) is made of heat-resistant material and is moved indirectly by the inner magnet of the socket (211).

[0363] In a non-opened state of the sterile connector according to the invention, the return spring of the plug (220) presses the plunger of the plug (219), which consists of heat-resistant material, with the inner seal of the plug (217) with respect to the channel (D) in the direction of the end face of the plug against the front housing part of the plug (216) (Figure 12).

[0364] The third embodiment of the sterile connector according to the invention also has a magnet system formed on the socket (202) consisting of a ring magnet (201) and the inner magnet of the socket (211) (Figures 12 to 14). The ring magnet (201) is formed on the outside of the socket, and the inner magnet of the socket (211) is formed inside the socket, both being formed at the same height of the longitudinal axis of the socket on the connection area side relative to the remaining longitudinally displaceable elements (206, 207, 209, 214). The ring magnet (201) moves the inner magnet of the socket (211) inside the socket. This displaces the remaining longitudinally displaceable elements of the socket (206, 207, 209, 214).In the plugged-in state of the sterile connector according to the invention, the displacement of the magnet system (201, 211) toward the connection area of ​​the plug (D) causes the remaining longitudinally displaceable elements of the socket and the longitudinally displaceable elements of the plug to also be displaced toward the connection area of ​​the plug (D), and the respective spring system of the socket and plug is compressed. As a result, the respective channel closure system of the socket and plug no longer closes the socket and plug, and a fluid connection is established between the first and second closed systems. The sterile connector according to the invention is in an open state.Furthermore, the third embodiment comprises a contact surface sealing system designed to seal the surfaces defining the contact surface, namely the outer seal of the plug (218) and a channel sealing system designed to seal the channel (B) of the socket and the channel (C) of the plug, namely the sealing ring of the socket (214) with regard to the socket and the inner seal of the plug (217) with regard to the plug.

[0365] Figures 12, 13 and 14 show a method according to the invention for sterilely connecting a first closed system to a second closed system using the third embodiment of the sterile connector according to the invention.

[0366] In a first method step a), a first and a second closed system are provided, each of which is reversibly or integrally connected to the connection areas of a socket (A) or a plug (D) of a sterile connector according to the invention according to the third embodiment, and an induction coil for inductive heating is provided. The sterile connector according to the invention is in a separated state according to Figure 12. Subsequently, in a method step b), the socket (202) and the plug (203) of the at least one sterile connector are brought together in the plugged-in state according to Figure 13. In this process, the plug head of the plug is pushed far enough into the plug receptacle of the socket that the end faces of the plug and socket lie against one another over their entire surface and define a contact surface of the plug receptacle and the plug head.The components forming the end face of the socket are the front panel of the socket (209) and the sterilization sleeve of the socket (210), and the components forming the end face of the plug are the front panel of the plug (215), the front housing part of the plug (216), and optionally the outer seal of the plug (218). Some of the components (209, 210, 215, 216) defining the contact surface of the socket and the plug are inductively heatable, in particular consisting of an inductively heatable material, or they are completely inductively heatable. If only one part is inductively heatable, the other part of the components (209, 210, 215, 216) defining the contact surface of the plug receptacle and the plug head is heatable, in particular consisting of a heatable material, in such a way that the entire surfaces defining the contact surface are heatable.

[0367] In a method step c), the sterile connector according to the invention is inductively heated. The induction coil, which surrounds the inductively heatable part of the components (209, 210, 215, 216) of the socket and plug outside the socket (202) and plug (203) in the plugged-in state, is energized. The magnetic field inside the induction coil heats the inductively heatable part of the components (209, 210, 215, 216) and the heatable part of the fully abutting surfaces of the components (209, 210, 215, 216) to a temperature and for a time sufficient to sterilize the surfaces defining the contact surface, i.e. to render biologically harmless any possible contamination on the surface of the components (209, 210, 215, 216) of the socket and the plug that form the contact surface.Once the temperature and time are reached, the power is turned off. It is then preferable to wait until the heated components have cooled down to a temperature at which the medium being transferred is stable and will not be damaged.

[0368] Thereafter, in a method step d), the channel closure systems (209, 214, 215, 217) of the plug and the socket of the at least one sterile connector are opened, whereby a fluid connection is established between the first and second closed systems through the at least one sterile connector.

[0369] When the channel closure systems are opened according to process step d), the longitudinally displaceable components of the socket and plug are pushed toward the connection area of ​​the plug (D) (Figure 14) by means of the magnet system (201, 211). The sterile connector according to the invention is in an open state.

[0370] The components (206), (207), (209), (214), (215), (217), and (219) are moved relative to the respective channels of the socket and plug in the direction of at least one connection area (D) of the plug using the magnetic system (201, 211). In this process, the return elements (213) and (220), designed as springs, are compressed.

[0371] This movement pushes the sealing ring of the socket (214) away from the sterilization sleeve (210) and simultaneously pushes the inner seal of the plug (217) away from the front housing part of the plug (216), opening the channels (B, C) so that the sterile connector according to the invention is in an open state. According to Figure 14, the fluid can flow along the dashed line through the sterile connector according to the invention from a first or second closed system into the other closed system.

[0372] Disconnecting the connection is done in reverse order of the described steps, but without the heating step. Example 4

[0373] Figure 15 shows an external view of a fourth embodiment of a sterile connector according to the invention, comprising a socket (302), a plug (303), and a ring magnet (301). The socket (302) and the ring magnet (301) are shown on the left side of Figure 15, and the plug (303) is shown on the right side, separated from one another, i.e., in a separated state of the sterile connector according to the invention. The ring magnet is located on the left side of the socket.

[0374] In Figure 16, the fourth embodiment of the sterile connector according to the invention comprising a socket (302) on the left and a plug (303) on the right next to each other in a separated state of the sterile connector according to the invention is shown in longitudinal section.

[0375] Figure 17 shows the fourth embodiment of the sterile connector according to the invention in a plugged-in state. Figure 18 shows the fourth embodiment of the sterile connector according to the invention in an open state. The individual components of the fourth embodiment of a sterile connector according to the invention and their function, as well as a method according to the invention using the third embodiment of the sterile connector according to the invention, are described below with reference to Figures 16 to 17.

[0376] In Figure 16, both the components forming the end faces and side wall surfaces of the plug receptacle of the socket (309, 310) and one of two components forming the end face of the plug head (315) are made of an inductively heatable material. The components forming the side wall surfaces of the plug head (316, 318), however, are made of a heatable material. When the surfaces of the end faces and side wall surfaces of the plug receptacle and the plug head are in full contact with one another, a contact surface is defined.The outer seal of the plug (318) is positioned on the surface of one of the components forming the side wall surfaces of the plug head (316), in particular at the obliquely designed transition from the respective side wall surface to the end surface, such that when the two components are in full contact with one another, in particular when not separated, at least part of the contact surface, in particular the entire contact surface defined by the end surfaces and side wall surfaces is peripherally enclosed on all sides by the outer seal of the plug (318) and no undesired material, i.e. no contamination, reaches the surfaces to be heated, i.e. sterilized, enclosed by the outer seal of the plug (318).In such an embodiment, i.e. if at least of either the plug receptacle or the plug head, the surfaces of the components forming the end face and side wall surfaces and of the respective other the surface of the components forming the end face have or consist of inductively heatable or heatable materials, a seal, in particular an annular seal, on the surfaces of the components forming the side wall surfaces, in particular on at least part of the part of the surfaces defining the contact surface, in particular at the transition from the respective side wall surface to the end face, is helpful, in particular necessary, in order to prevent the penetration into the interior, in particular into the channel, of the sterile connector according to the invention of undesired materials, in particular contamination, in particular after the sterilization step.

[0377] The channel (C) of the plug is formed by the front housing part of the plug (316) and the rear housing part of the plug (323).

[0378] The plunger of the plug (319) and the components (315, 316, 317, 334, 333) close the channel (C). To ensure that the medium to be transported flows around the plunger of the plug (319), it is designed as shown in Figure 19. The medium to be transported flows along the channel (C) along fluid channels of the plunger of the plug (319). The medium to be transported is guided through the plug through the channel (C) (Figure 18).

[0379] The channels of the socket and the plug (B, C) each have a reversible channel closure system in the front area of ​​the respective channel, namely the front plate of the socket (309) and a sealing ring of the socket (314) with respect to the socket, and the front plate of the plug (315) and an inner seal of the plug (317) with respect to the plug. The sealing ring of the socket (314) is made of heatable material and prevents contamination between the socket housing (308) and the front plate of the socket (309) from entering the interior of the socket when the sterile connector according to the invention is not opened. The inner seal of the plug (317) is made of heatable material and prevents contamination between the front housing part of the plug (316) and the front plate of the plug (315) from entering the interior of the plug when the sterile connector according to the invention is not opened.

[0380] The reversible channel closure system of the socket (309, 314) is functionally connected to a reset element, namely a magnetic device of the socket consisting of two inner retention magnets of the socket (331) and an outer retention magnet of the socket (332) that interacts with the two inner retention magnets of the socket (331). The reversible channel closure system of the plug (315, 317) is functionally connected to a reset element, namely a magnetic device of the plug consisting of an inner retention magnet of the plug (333) and an outer retention magnet of the plug (335) that interacts with the inner retention magnet of the plug (333).

[0381] The magnetic device of the socket (331, 332) is functionally connected to seven elements that are longitudinally displaceable relative to the channel (B), namely a magnetic cover of the socket (306), a plunger of the socket (307), a spacer of the inner magnets (330), the front plate of the socket (309), two inner magnets of the socket (311), and the sealing ring of the socket (314). The magnetic device of the plug (333, 335) is functionally connected to four longitudinally displaceable elements, namely the front plate of the plug (315), the inner seal of the plug (317), a plunger of the plug (319), and a connecting element (334) between the plunger of the plug (319) and the front plate of the plug (315). The respective inner return magnets (331, 333) are also longitudinally displaceable.

[0382] By means of the magnetic device of the socket (331, 332) and the magnetic device of the plug (333, 335), a force, in particular a restoring force, is transmitted to the respective functionally connected longitudinally displaceable elements, in particular the plunger of the socket (307) and the plunger of the plug (319).

[0383] As a result, in a non-opened state of the sterile connector according to the invention, the magnetic device of the socket (331, 332) presses the functionally connected, longitudinally displaceable elements with respect to the channel (B) toward the connection area (A) of the socket. This presses the sealing ring of the socket (314) against the sterilization sleeve of the socket (310) (Figure 16). The magnetic cover of the socket (306) prevents the medium to be transported from coming into contact with the internal magnets of the socket (311, 331). The magnetic cover of the socket (306) is optional if the internal magnets of the socket (311, 331) are compatible with the medium to be transported.

[0384] The plunger of the bushing (307) is made of heat-resistant material and is moved indirectly by the inner magnet of the bushing (311).

[0385] In a non-opened state of the sterile connector according to the invention, the magnetic device of the plug (333, 335) presses the plunger of the plug (319), which consists of heat-resistant material, with the inner seal of the plug (317) with respect to the channel (D) in the direction of the end face of the plug against the front housing part of the plug (316) (Figure 16).

[0386] The fourth embodiment of the sterile connector according to the invention also has a magnet system formed on the socket (302) consisting of a ring magnet (301) and two inner magnets of the socket (311) (Figures 16 to 18). The ring magnet (301) is formed on the outside of the socket, and the inner magnets of the socket (311) are formed inside the socket, both being formed at the same height of the longitudinal axis of the socket on the connection area side relative to the remaining longitudinally displaceable elements (306, 307, 309, 314). The ring magnet (301) moves the inner magnets of the socket (311) inside the socket. This displaces the remaining longitudinally displaceable elements of the socket (306, 307, 309, 314, 330) as well as the two inner retaining magnets of the socket (331).

[0387] In the plugged-in state of the sterile connector according to the invention, the remaining longitudinally displaceable elements of the socket and the longitudinally displaceable elements of the plug are also displaced in the direction of the connection area of ​​the plug (D) by displacing the magnet system (301, 311) in the direction of the connection area of ​​the plug (D). The displacement of the magnet system overcomes the force transmitted to the respective functionally connected longitudinally displaceable elements, in particular the restoring force, of the respective magnet device. The respective inner restoring magnets (331, 333) are also displaced in the direction of the connection area of ​​the plug (D), in particular within the length of the respective outer retaining magnet (332, 335). As a result, the respective

[0388] The channel closure system of the socket and plug no longer seals the socket and plug, and a fluid connection is established between the first and second closed systems. The sterile connector according to the invention is in an open state.

[0389] Furthermore, the fourth embodiment comprises a contact surface sealing system designed to seal the surfaces defining the contact surface, namely the outer seal of the plug (318) and a channel sealing system designed to seal the channel (B) of the socket and the channel (C) of the plug, namely the sealing ring of the socket (314) with regard to the socket and the inner seal of the plug (317) with regard to the plug.

[0390] Figures 16, 17 and 18 show a method according to the invention for sterilely connecting a first closed system to a second closed system using the third embodiment of the sterile connector according to the invention. In a first method step a), a first and a second closed system are provided, each of which is reversibly or integrally connected to the connection areas of a socket (A) or a plug (D) of an inventive sterile connector according to the third embodiment, and an induction coil for inductive heating. The sterile connector according to the invention is in a separated state according to Figure 16. Subsequently, in a method step b), the socket (302) and the plug (303) of the at least one sterile connector are brought together in the plugged-in state according to Figure 17.The plug head is pushed into the plug receptacle of the socket until the end faces of the plug and socket are in full contact, defining a contact surface between the plug receptacle and the plug head. The components forming the end face of the socket are the front panel of the socket (309) and the sterilization sleeve of the socket (310), while the components forming the end face of the plug are the front panel of the plug (315), the front housing part of the plug (316), and optionally the outer seal of the plug (318).Some of the components (309, 310, 315, 316) defining the contact surface of the socket and the plug are inductively heatable, in particular consisting of an inductively heatable material, or they are completely inductively heatable. If only one part is inductively heatable, the other part of the components (309, 310, 315, 316) defining the contact surface of the plug receptacle and the plug head is heatable, in particular consisting of a heatable material, in such a way that the entire surfaces defining the contact surface are heatable. Preferably, the outer seal of the plug (318) is also heatable, in particular consisting of a heatable material.

[0391] In a method step c), the sterile connector according to the invention is inductively heated. The induction coil, which surrounds the inductively heatable part of the components (309, 310, 315, 316) of the socket and plug outside the socket (302) and plug (303) in the plugged-in state, is energized.The magnetic field inside the induction coil heats the inductively heatable part of the components (309, 310, 315, 316) and the heatable part of the fully abutting surfaces of the components (309, 310, 315, 316) as well as optionally the outer seal of the plug (318) to a temperature and for a time sufficient to sterilize the surfaces defining the contact surface, i.e. to render biologically harmless any possible contamination on the components (309, 310, 315, 316) of the socket and plug forming the surface defining the contact surface, as well as optionally the outer seal of the plug (318). Once the temperature and time are reached, the power is switched off.It is preferable to then wait until the heated components have cooled down to a temperature at which the medium to be transferred is stable and will not be damaged.

[0392] Thereafter, in a method step d), the channel closure systems (309, 314, 315, 317) of the plug and the socket of the at least one sterile connector are opened, whereby a fluid connection is established between the first and second closed systems through the at least one sterile connector.

[0393] When the channel closure systems are opened according to process step d), the longitudinally displaceable components of the socket and plug are pushed toward the connection area of ​​the plug (D) (Figure 18) by means of the magnet system (301, 311). The sterile connector according to the invention is in an open state.

[0394] The components (306), (307), (309), (331), (314), (315), (317), (319), (333) and (334) are moved in relation to the respective channels of the socket and the plug in the direction of the at least one connection area (D) of the plug by means of the magnet system (301, 311). The respective inner return magnets (331, 333) are therefore also displaced in the direction of the connection area of ​​the plug (D), in particular within the length of the respective outer retaining magnet (323, 335), in particular such that during the displacement the respective inner return magnets (331, 333) are not pushed beyond a limit point, in particular the starting or end point of the length of the respective outer retaining magnet (323, 335), in particular such that the respective channel (B, C) can be closed again upon opening by the force of the respective magnetic return element, in particular of the respective magnetic device.

[0395] This movement pushes the sealing ring of the socket (314) away from the sterilization sleeve (310) and simultaneously pushes the inner seal of the plug (317) away from the front housing part of the plug (316), opening the channels (B, C) so that the sterile connector according to the invention is in an open state. According to Figure 18, the fluid can flow along the dashed line through the sterile connector according to the invention from a first or second closed system into the other closed system.

[0396] The fluid flows along the respective plunger (307, 319) in the socket and plug. Figure 19 shows a cross-section of a plunger (307, 319) present in the socket and plug. The respective plungers (307, 319) have fluid channels in the form of recesses. The respective plungers (307, 319) have guide surfaces. The plungers (307, 319) are displaced longitudinally along the guide surfaces. Disconnection occurs in the reverse order of the described steps, but without the heating step.

Claims

CLAIMS 1. Sterile connector for the sterile connection of a first closed system with a second closed system comprising: - a socket (1, 102) having at least one connection area (A) to the first or second closed system, at least one plug receptacle configured to receive a plug head, wherein the plug receptacle has side wall surfaces formed by at least one component (5, 11, 12, 108, 110) and an end face of the socket formed by at least one component (8, 17, 109, 110), at least one channel (B) running from the connection area (A) of the socket to the plug receptacle; - a plug (2, 103) having at least one connection area (D) to the first or second closed system, at least one plug head configured for insertion into the plug receptacle, wherein the plug head has side wall surfaces formed by at least one component (20, 21, 116, 118) and an end face of the plug head formed by at least one component (18, 20, 115, 116, 118), at least one channel (C) running from the connection area (D) of the plug to the plug head, wherein the plug receptacle and the plug head are designed so,that in the plugged-in state, the end faces of the plug receptacle and the plug head lie against one another over their entire surface and define a contact surface of the plug receptacle and the plug head, and wherein at least a part of the surface of the plug receptacle defining the contact surface is inductively heatable and / or at least a part of the surface of the plug head defining the contact surface is inductively heatable such that the entire surfaces defining the contact surface are heatable, wherein the channels of the socket and the plug (B, C) each have at least one, in particular reversible, channel closure system (7, 21, 109, 114, 115, 117) in the end region of the respective channel, which is each functionally connected to at least one reset element (6, 13, 27, 113, 120), wherein in each case the at least one reset element (6, 13, 27, 113, 120) is connected to at least one relative to the respective channel longitudinally movable element, (7, 8, 9, 15, 19, 20, 21, 22, 23, 24, 28, 106, 107, 109, 111, 112, 114, 115, 117, 119) and wherein the channels (B, C) are designed to establish a fluid connection between the first closed system and the second closed system.

2. Sterile connector according to claim 1, wherein the plug receptacle and the plug head are designed such that, in the plugged-in state, the end faces and side wall surfaces of the plug receptacle and the plug head lie against one another over their entire surface and define a contact surface of the plug receptacle and the plug head, and wherein the end faces and side wall surfaces of the plug receptacle and the plug head are made of heatable material.

3. Sterile connector according to one of the preceding claims, wherein the at least one component (8, 17, 109, 110) forming the end face of the socket at least partially has a contact surface and / or the at least one component (18, 20, 115, 116, 118) forming the end face of the plug at least partially has a contact surface and / or contains an inductively heatable material and / or a heatable material or consists of an inductively heatable material or a heatable material.

4. Sterile connector according to claim 1 or 2, wherein the at least one component (5, 11, 12, 108, 110) forming the side wall surface of the plug receptacle at least partially has a contact surface and / or at least one component (20, 21, 116, 118) forming the side wall surface of the plug head at least partially has a contact surface and / or contains an inductively heatable material and / or a heatable material or consists of an inductively heatable material or a heatable material.

5. Sterile connector according to one of the preceding claims, wherein the components (14, 26, 108, 116, 121) forming the channels of the socket and the plug (B, C), at least one component of the at least one channel closure system of the socket and the plug (7, 21, 109, 114, 115, 117) and the components (4, 29, 105, 121) forming the at least one connection area of ​​the socket and the plug (A, D) consist of a heat-resistant material.

6. Sterile connector according to one of the preceding claims, wherein the at least one return element (6, 13, 27, 113, 120) is a spring system or a magnetic device.

7. Sterile connector according to one of the preceding claims, comprising a foldable sealing sleeve (25), in particular made of an elastic material, formed in particular on the plug (2, 103).

8. Sterile connector according to one of claims 1 to 6, comprising a magnet system (101, 111) formed, in particular, on the socket (102) or the plug (103), wherein the magnet system comprises at least one first magnet (101, 111) and at least one second magnet or at least one magnetic material, wherein either the at least one first magnet, in particular a permanent magnet or electromagnet, or the at least one magnetic material is formed outside the socket (102) or on the plug (103) and the at least one first or second magnet or at least one magnetic material is formed inside the socket (102) or the plug (103), in particular both at the same height of the longitudinal axis of the socket or the plug, in particular on the connection area side to the at least one longitudinally displaceable element (106, 107, 109, 111, 112, 114, 115, 117, 119), such that the magnet system (101, 111) the at least one longitudinally displaceable element (106, 107, 109,111, 112, 114, 115, 117, 119) is longitudinally displaceable., 9. Sterile connector according to one of the preceding claims, wherein the at least one return element (6, 13, 27, 113, 120) is a spring system or a magnetic device and is designed to open the channel closure system (7, 21, 109, 114, 115, 117) of the socket and the plug upon compression of the spring system or displacement of the magnetic device, in particular by the at least one longitudinally displaceable element (7, 8, 9, 15, 19, 20, 21, 22, 23, 24, 28, 106, 107, 109, 111, 112, 114, 115, 117, 119) of the socket and / or the plug, in particular up to a stop point, whereby a Fluid connection is formed between the first closed system and the second closed system.

10. Sterile connector according to one of the preceding claims, comprising at least one contact surface sealing system (11, 12, 118) designed to seal the surfaces defining the contact surface and / or at least one channel sealing system (15, 16, 19, 22, 114, 117) designed to seal the channel (B) of the socket and the channel (C) of the plug.

11. A method for sterilely connecting a first closed system to a second closed system, comprising the following method steps: a) Providing a first and a second closed system, each of which is reversibly or integrally connected to a socket (1, 102) or a plug (2, 103) of at least one sterile connector according to one of claims 1 to 10, and a device for inductive heating, b) Bringing the socket (1, 102) and the plug (2, 103) of the at least one sterile connector together in the plugged-in state, in particular such that the end faces of the plug receptacle and the plug head bear against one another over their entire surface and define a contact surface of the plug receptacle and the plug head, c) Inductively heating the sterile connector, in particular at least part of the surface of the plug head and / or the plug receptacle defining the contact surface, to a temperature and for a time sufficient to sterilize the surfaces defining the contact surface, in particular at least 160°C, in particular 180°C,by means of the device for inductive heating, and d) opening the channel closure systems (7, 21, 109, 114, 115, 117) of the plug and the socket of the at least one sterile connector, whereby a fluid connection is established between the first and second closed systems through the at least one sterile connector.

12. The method according to claim 11, wherein the opening of the at least one channel closure system (7, 21, 109, 114, 115, 117) of the socket and the plug of the at least one sterile connector in method step d) is carried out by displacing the at least one longitudinally displaceable element (7, 8, 9, 15, 19, 20, 21, 22, 23, 24, 28, 106, 107, 109, 111, 112, 114, 115, 117, 119) to actuate the at least one return element (6, 13, 27, 113, 120), wherein in particular the at least one return element is a spring system and the actuation is a compression of the spring system.

13. The method according to claim 12, wherein the displacement of the at least one longitudinally displaceable element (106, 107, 109, 111, 112, 114, 115, 117, 119) of the plug or the socket of the at least one sterile connector, in particular the socket of the at least one sterile connector, is carried out by means of magnetic force.

14. Method according to one of claims 11 to 13, wherein, after method step c) and before the transport of the liquid from the first and / or second closed system in a method step c1), a cooling of the sterile connector, in particular of the at least one part the surface of the plug head and / or the plug receptacle defining the contact surface, in particular by flushing or by air.

15. Device for, in particular automated, sterile connection of a first closed system to a second closed system, in particular by means of a method according to one of claims 11 to 14, comprising - at least one sterile connector according to one of claims 1 to 10, - a first closed system connected to the socket (1, 102) or the plug (2, 103) of the at least one sterile connector, in particular integrally or reversibly, - a second closed system connected to the socket (1, 102) or the plug (2, 103) of the at least one sterile connector, in particular integrally or reversibly, and, optionally, - at least one device for inductive heating.

16. The device of claim 15, further comprising - a linear unit, in particular a motorized one, on which either the socket (1, 102) or the plug (2, 103) of the at least one sterile connector with at least a part of the first or second closed system is located, and - a fastening for fixing either the plug or the socket of the at least one sterile connector to at least a part of the first or second closed system.

17. Device according to claim 15 or 16, wherein the device for inductive heating is an induction coil, in particular in the form of a spiral or a horseshoe, which can be arranged at least around the outer circumference of the socket (1, 102) or the plug (2, 103) of the at least one sterile connector, in particular around the socket (1, 102) or the plug (2, 103) of the at least one sterile connector, which is fixed to the fastening.

18. Device according to one of claims 16 or 17, wherein the, in particular motorized, linear unit is a power-driven mechanical guide and has a movable carriage on which the socket (1, 102) or the plug (2, 103) of the at least one sterile connector can be fixed and wherein the device further comprises a control unit which controls the connection between the socket (1, 102) located on the linear unit or the plug (2, 103) of the at least one sterile connector and the socket (1, 102) fixed to the fastening or the plug (2, 103) of the at least one sterile connector.

19. Device according to one of claims 15 to 18, wherein the device further comprises a device which can cool the at least one sterile connector, preferably by means of a gas stream, preferably air.

20. A method for the sterile transfer of biologically active media, comprising the following method steps: a) providing a first and a second closed system, each of which is reversibly or integrally connected to a socket (1, 102) or a plug (2, 103) of at least one sterile connector according to one of claims 5 to 10, and either the first and / or the second closed system contains a biologically active medium, and a device for inductive heating, b) bringing the socket (1, 102) and the plug (2, 103) of the at least one sterile connector together in the plugged-in state, in particular such that the end faces of the plug receptacle and the plug head lie against one another over their entire surface and define a contact surface of the plug receptacle and the plug head, c) inductively heating the sterile connector,in particular of at least a part of the surface of the plug head and / or the plug receptacle defining the contact surface, to a temperature and for a time sufficient to sterilize the surfaces defining the contact surface, in particular at least 160 °C, in particular 180 °C, by means of the device for inductive heating, and d) opening the channel closure systems (7, 21, 109, 114, 115, 117) of the plug and the socket of the at least one sterile connector, whereby a fluid connection is established between the first and second closed systems through the at least one sterile connector.

21. The method according to claim 20, wherein after method step c) and before the transport of the biologically active medium from the first and / or second closed system in a method step c1) a cooling of the sterile connector, in particular of at least a part of the surface of the plug head and / or the plug receptacle defining the contact surface, at a temperature compatible with biologically active medium, in particular below 37 °C.

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