Sterile connector

DE102023205195B4Active Publication Date: 2026-07-09FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV
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Patent Information

Authority / Receiving Office
DE · DE
Patent Type
Patents
Current Assignee / Owner
FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV
Filing Date
2023-06-02
Publication Date
2026-07-09

AI Technical Summary

Technical Problem

Existing sterile connectors for connecting closed systems face challenges in ensuring aseptic and contamination-free transfer of biologically active media without altering their chemical or biological activity, while also being reusable without complex and cost-intensive process steps.

Method used

A sterile connector design featuring a socket and plug with inductively heatable end faces and channels, allowing for full-surface contact and inductive sterilization, enabling aseptic connection and disconnection without cavities, and allowing for reuse without additional processing.

Benefits of technology

Ensures aseptic transfer of biologically active media while maintaining their integrity, reduces contamination risk, and allows for multiple uses without complex reprocessing, meeting regulatory standards like GMP.

✦ Generated by Eureka AI based on patent content.

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Abstract

Sterile connector for 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 for receiving 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) extending 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 formed by at least one component (18, 20, 115, 116,118) has a formed end face of the plug head, at least one channel (C) extending from the connection area (D) 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 are in full contact with each other 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 face area of ​​the respective channel,each of which is functionally connected to at least one restoring element (6, 13, 27, 113, 120), wherein each of the at least one restoring element (6, 13, 27, 113, 120) is functionally connected to at least one element (7, 8, 9, 15, 19, 20, 21, 22, 23, 24, 28, 106, 107, 109, 111, 112, 114, 115, 117, 119) that is longitudinally displaceable with respect to the respective channel, and wherein the channels (B, C) are designed to establish a fluid connection between the first closed system and the second closed system.
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Description

[0001] The present invention relates to sterile connectors for the sterile connection of a first closed system with a second closed system, methods for the sterile connection of a first closed system with a second closed system, methods for the sterile transfer of biologically active media and devices for the sterile connection of a first closed system with a second closed system.

[0002] 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, particularly a first container, to a second closed system, particularly a second container. It is essential to ensure that the transfer, i.e., transport, of the medium being moved is aseptic and contamination-free. At every stage of the transfer, it must be prevented that contaminants, such as unwanted materials, especially foreign bodies like bacteria, enter and contaminate the medium. The media being moved typically possess desired chemical and / or biological activities, such as enzymatic, catalytic, or cell-bound activities, and are therefore often thermo- or UV-sensitive.

[0003] To transfer the medium from a first closed system to a second closed system, a fluid connection between the two systems must be established. This requires opening both closed systems. Due to the risk of contamination, this opening is a critical process step that places high technical demands on the connection system, particularly a sterile connector.

[0004] A known method for connecting two closed systems is hose welding. In this process, two hoses are placed in a device that welds them together, creating a bonded 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. Reusing the hoses is also considerably more difficult due to the bonded nature of the connection.

[0005] In addition to the described material-bonded connection, various methods are known for creating force-fit and form-fit connections between two closed systems. These methods are based on connectors, where connector components are attached to the respective systems. The connection between the vessels is achieved by joining the connector parts.

[0006] EP 3 270 979 B1 discloses a sterile connector in which contaminated surfaces are sterilized using UV light before the connection is made. To establish a fluid connection, a membrane is pierced after sterilization.

[0007] EP 0 121 980 B1 discloses a device for sterilizing a sterile connector using inductive heating. The sterile connector is placed inside an L-shaped coil. The electromagnetic field heats and sterilizes electrically conductive components of the sterile connector. Only specific parts of the sterile connector are conductive and therefore capable of inductive heating. The exact design of the sterile connector is not described.

[0008] US patent 11,090,478 B2 discloses a sterile connector consisting of a socket and a plug, the socket and plug forming a chamber when positioned together. This chamber can be sterilized, for example, by means of 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, for example, in the form of heat or UV light.

[0009] Sterile connectors are also known in which the contact surfaces are sealed with foil. These foils are removed when the two connector parts are connected, preventing any contamination from entering 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 procedures.

[0010] The present invention therefore addresses the technical problem of overcoming the disadvantages of the prior art, in particular providing a sterile connector that makes it possible to connect two closed systems and reuse them without complex and costly process steps. Specifically, the present invention addresses the technical problem of connecting a first closed system to a second closed system aseptically and without contamination using a sterile connector, i.e., without allowing contaminants from unwanted materials, such as bacteria and / or fungi, to enter the closed systems from outside, and thus meeting regulatory requirements, such as GMP.The present invention is based in particular on the technical problem of providing a aforementioned sterile connector and methods for using it, which make it possible to transfer media, in particular biological media, from a first to at least a second closed system without contamination, i.e. transporting them without altering the chemical or biological activity of the transferred media, in particular without being affected by thermal energy.

[0011] 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.

[0012] In particular, the present invention solves the underlying technical problem by providing a sterile connector for the sterile connection of a first closed system with a second closed system, comprising: - having a socket at least one connection area to the first or second closed system, at least one plug receptacle configured for receiving 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 socket's connection area to the plug receptacle; - having a plug 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 running from the connector area to the connector head, wherein the connector receptacle and the connector head are designed such that, in the inserted state, the end faces of the connector receptacle and the connector head are in full contact with each other and define a contact surface of the connector receptacle and the connector head, and wherein at least a part of the surface of the connector receptacle defining the contact surface is inductively heatable and / or at least a part of the surface of the connector head defining the contact surface is inductively heatable such that the entire surface defining the contact surface is heatable. wherein the channels of the socket and the plug each have at least one, in particular reversible, channel closure system in the end face area of ​​the respective channel, which is each functionally connected to at least one return element, wherein each of the at least one return element is functionally connected to at least one element which is longitudinally displaceable in relation 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.

[0013] 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 comprises at least one plug receptacle configured for receiving a plug head. The plug further comprises 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 and plug, respectively, formed by at least one component. The socket and the plug further each have at least one channel extending from the connection area of ​​the socket to the plug receptacle and from the connection area of ​​the plug to the plug head, respectively.

[0014] 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 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 areas of the socket and plug in such a way that each closed system connected to the connection area of ​​the socket or plug forms a new closed system with the socket or plug. Preferably, the respective previous closed system is open after being connected to the connection area of ​​the socket or plug and forms a new closed system with the socket or plug.Preferably, the respective new closed system is sealed by the channel sealing 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 separated state during this process. The socket and plug of the sterile connector according to the invention do not touch each other in this separated state and are therefore spatially separated from one another.After connecting the first and second closed systems, the plug head of the connector is pushed into the socket receptacle until 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; that is, one closed system is connected to the connection area of ​​the socket and the other closed system to the connection area of ​​the plug. Sterilization, in particular gamma sterilization, is then preferably carried out on the closed systems connected to the socket or plug of the sterile connector according to the invention.

[0015] According to the invention, the connector receptacle and the connector head are designed such that, when inserted, the end faces of the connector receptacle and the connector head rest against each other over their entire surface, defining a contact surface. The at least one longitudinally displaceable element of the socket and the plug, when the sterile connector according to the invention is inserted, has not yet undergone any longitudinal displacement relative to the respective at least one channel, so that the end faces of the connector receptacle and the connector head, which rest against each other over their entire surface, are not subjected to any force when inserted.

[0016] In the invention, where the end faces of the connector receptacle and the connector head are in full-surface contact, at least one of the end faces, preferably both end faces, are in direct contact with the other end face over their entire surface, such that no cavities are formed. The end face surfaces thus lie directly against each other, allowing heat transfer between them with no or no significant energy loss. By being in full-surface contact, the end faces of the connector receptacle and the connector head define a contact surface, i.e., a virtual surface, which is defined by the directly contacting end faces of the connector receptacle and the connector head.

[0017] 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.

[0018] It is also preferably 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, during inductive heating, all surfaces defining the contact area are heated, even if they themselves are not inductively heatable. The heating and thus sterilization of these surfaces of the connector head and the receptacle can therefore be achieved 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 material.but the heat transfer occurs in the material of the second end face, which is in direct contact with 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.

[0019] When the sterile connector according to the invention is plugged in, the surfaces of the plug receptacle and the plug head, which are in full contact and define a contact surface, are heated at least partially, in particular by a coil, inductively, so that all surfaces defining the contact surface are heated.

[0020] At least a part of the contact surface of the connector receptacle and / or at least a part of the contact surface of the connector head can be inductively heated so that the entire contact surface can be heated.

[0021] The entire contact surface of the connector receptacle and the entire contact surface of the connector head can be inductively heated, or only one entire contact surface of the connector receptacle or connector head can be inductively heated, while the other entire contact surface is heated but not inductively heated. It is also possible that only part of the contact surface of the connector receptacle or connector head can be inductively heated, while the other entire contact surface can be heated.It is also possible for a part, for example an upper part, the contact surface defining the contact area of ​​the connector receptacle, and a part, for example a lower part, the contact surface defining the contact area of ​​the connector head, which does not touch the part, for example an upper part, that defines the contact surface of the connector receptacle when fully in contact, to be inductively heated, and for the respective other parts of the contact surface defining surfaces of the connector receptacle and the connector head to be heated, so that during inductive heating all the contact surface defining surfaces of the connector receptacle and the connector head are heated.Preferably, the heatable parts of the surfaces defining the contact areas of the connector receptacle and the connector head, i.e., those that are not inductively heatable, are heated by heat transfer from the inductively heatable parts of the surfaces defining the contact area of ​​the connector receptacle and the connector head that are heated by inductive heating, such that the entire surfaces forming the contact area are heated. According to the invention, therefore, the entire surfaces defining the contact area of ​​the connector receptacle and the connector head are heatable, and it is not necessary that the entire surfaces defining the contact area of ​​the connector receptacle and the connector head be inductively heatable.

[0022] In this way, it is ensured that all surfaces of the plug head and plug receptacle that define the contact area can be heated and thus sterilized.

[0023] The inductive heating capability provided according to the invention is achieved by manufacturing the inductively heatable surfaces defining the contact area, in particular the components comprising these surfaces, from an inductively heatable material. The heating capability provided according to the invention is also achieved by manufacturing the inductively heatable surfaces defining the contact area, in particular the components comprising these surfaces, from a heatable material. In a preferred embodiment, the inductively heatable and / or heatable surfaces constitute an integral part of the components of the socket and / or the plug, in particular 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 plug receptacle, which have 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.A component made of an inductively heatable or heatable material with a surface coating that is made of a thermally insulating material is preferred, as this reduces the energy required for sterilization and shortens the cooling time of the heated surfaces.

[0024] If the channel closure systems of the socket and the plug, each functionally connected with at least one return element and each functionally connected with at least one longitudinally displaceable element, are actuated by 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 longitudinally displaceable element in relation 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, whereby 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 longitudinally displaceable element of the socket and plug relative to the respective at least one channel has undergone a longitudinal displacement in the direction of a connection area of ​​the socket or 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 area of ​​the socket or plug, the respective at least one reset element and the respective at least one channel closure system, which closes the channels in the unopened 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.

[0025] Preferably according to the invention, the sterile connector can be in a connected state, wherein in the connected state the plug head is in the plug receptacle and the at least one longitudinally displaceable element of the socket and plug relative to the respective at least one channel has undergone a longitudinal displacement in the direction of a connection area of ​​the socket or 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 area of ​​the socket or plug of the respective at least one longitudinally displaceable element relative to the respective at least one channel is not yet completely completed.In the connected state, the sterile connector according to the invention is in a position between the plugged-in and the open state.

[0026] Preferably, the inductively heatable components of the sterile connector according to the invention are arranged and / or designed in such a way that they do not have contact with the medium to be transported, in particular with the liquid to be transported, during sterilization.

[0027] Preferably, the heatable components of the sterile connector according to the invention are arranged and / or designed in such a way that they do not have contact with the medium to be transported, in particular with the liquid to be transported, during sterilization.

[0028] Preferably, the inductively heatable components and the heatable components of the sterile connector according to the invention are arranged and / or designed in such a way that they do not have contact with the medium to be transported, in particular with the liquid to be transported, during sterilization.

[0029] This advantageously prevents damage to the medium being transported, particularly to the liquid. Preferably, the sterile connector according to the invention can be sterilized regardless of whether unwanted material, especially small amounts of solid material or liquids, are present on potentially contaminated surfaces, since the heat can penetrate the material, especially the small amounts of solid material or liquids on the potentially contaminated surfaces.According to the invention, the surfaces of the end faces defining the contact surface and optionally the side wall surfaces of the plug receptacle and 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, through the full-surface contact of the inductively heatable end faces and optionally the side wall surfaces of the plug receptacle and plug head.

[0030] In this way, all surfaces of the sterile connector according to the invention that can come into contact with the environment when the sterile connector is disconnected, and are therefore exposed to potential contamination, and that can come into contact with the medium being transported when the sterile connector is open, are sterilized and no longer exhibit any potential contamination. This preferably eliminates the need for membranes and films to seal the sterile connector, thus preventing the need to protect potentially contaminated surfaces of the sterile connector, and / or the need to use a cleanroom.Preferably, the sterile connector according to the invention can also be reused directly after use, without the need for complex and costly process steps, in particular the restoration of membranes and films destroyed by a connection and / or the reuse of a cleanroom.

[0031] Preferably, by ensuring that the end faces and, optionally, the side walls of the connector receptacle and the connector head of the sterile connector according to the invention are in full contact when plugged in, cavities between the connector receptacle and the connector head are minimized, and in particular eliminated. This preferably prevents air or other undesirable media from being present in the sterile connector according to the invention during the sterilization process, thus increasing the reliability of sterilization compared to known sterile connectors, especially those in which one or more cavities are formed. Preferably, by preventing cavities, the necessary sterilization time is reduced compared to known sterile connectors, especially those 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.

[0032] The channels of the socket and the plug each have at least one, in particular reversible, channel locking system in the end face of the respective channel. Each of these at least one, in particular reversible, channel locking systems is functionally connected to at least one return element. Each return element is functionally connected to at least one element that is longitudinally displaceable relative to the respective channel.

[0033] Preferably, due to the 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, it is not necessary for components, in particular films, of the socket and plug of the sterile connector according to the invention to be destroyed during connection. The channels of the socket and 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 allows the respective channels of the socket and plug to be closed again after initial use, i.e., after establishing a fluid connection. Preferably, the fluid connection can be established and disconnected 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 sterile connection almost without dripping, in particular without dripping. Preferably, this results in almost no dead volume, in particular no dead volume, being present in the sterile connector according to the invention.

[0034] In a preferred embodiment, the channel extending from the connection area of ​​the socket lies fluid-tight against the channel of the plug in an inserted, connected or open state of the sterile connector according to the invention.

[0035] In a preferred embodiment, the end face outlet or inlet area of ​​the channel of the socket connects fluid-tight to the end face outlet or inlet area of ​​the channel of the plug.

[0036] 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, and in particular are non-toxic and / or chemically stable, and suitable for the respective process.

[0037] In a preferred embodiment, the at least one component forming the end face of the socket contains at least partially contact surfaces, 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 contact surfaces, i.e., on a surface forming a contact surface, an inductively heatable material and / or heatable material, or it consists of an inductively heatable material or a heatable material.

[0038] 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 inserted state, the end faces and side wall surfaces 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, wherein the end faces and side wall surfaces of the plug receptacle and the plug head are made of heatable material.

[0039] In a preferred embodiment, the sterile connector for sterile connection of a first closed system with a second closed system comprises: - having a socket at least one connection area to the first or second closed system, at least one plug receptacle configured for receiving 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 socket's connection area to the plug receptacle; - having a plug 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 running from the connector area to the connector head, wherein the connector receptacle and the connector head are designed such that, in the inserted state, the end faces and side wall surfaces of the connector receptacle and the connector head are in full contact with each other and define a contact surface of the connector receptacle and the connector head, and wherein at least a part of the surface of the connector receptacle defining the contact surface is inductively heatable and / or at least a part of the surface of the connector head defining the contact surface is inductively heatable such that the entire surface defining the contact surface is heatable. wherein the channels of the socket and the plug each have at least one, in particular reversible, channel closure system in the end face area of ​​the respective channel, which is each functionally connected to at least one return element, wherein each of the at least one return element is functionally connected to at least one element which is longitudinally displaceable in relation 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.

[0040] In a preferred embodiment, the sterile connector according to the invention has a seal, in particular an annular seal, that peripherally surrounds the surfaces defining the contact area on all sides. In a preferred embodiment, the sterile connector according to the invention has a seal, in particular an annular seal, that peripherally surrounds at least a portion, and in particular the entire surface, defining the contact area on all sides. In a preferred embodiment, the end face of the connector receptacle and / or the connector head of the sterile connector according to the invention is partially formed by a seal, in particular an annular seal, that peripherally surrounds at least a portion, and in particular the entire surface, defining the contact area defined by the end faces of the connector receptacle and the connector head on all sides; in particular, a component forming the end face has this seal on the surface defining the contact area.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 circumferentially surrounds at least a 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 seal on the surface defining the contact surface.

[0041] Preferably, the seal prevents unwanted material, i.e., no contamination, from reaching the surfaces to be heated, i.e., sterilized, when the surfaces defining the contact area are in full contact with each other, particularly after the sterilization step. This preferably prevents the penetration of unwanted materials, especially contaminants, into the interior, particularly into the channel, of the sterile connector according to the invention, especially after the sterilization step.

[0042] In a preferred embodiment, the at least one component forming the side wall surface of the connector receptacle contains at least partially contact surfaces and / or at least one component forming the side wall surface of the connector head contains at least partially contact surfaces containing an inductively heatable material and / or a heatable material, or this consists of an inductively heatable material or a heatable material.

[0043] 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, X5CrNi18-10.

[0044] In a preferred embodiment, the heatable material of the heatable components is a plastic, in particular PEEK (polyetheretherketone) and / or PFA (perfluoroalkoxy).

[0045] In a preferred embodiment, the heat-resistant material of the heat-resistant components is a plastic, in particular polypropylene and / or polycarbonate.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] In a preferred embodiment, the at least one channel of the socket or plug of the sterile connector according to the invention is selected from at least one component 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 the Fig. 1 to 10, assembled.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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 sleeve, a connecting channel component, a housing, a mounting cover, a rear seal, a magnetic cover, a front disc, an inner magnet, a plunger holder, a sealing ring and an inner seal, in particular at least one longitudinally displaceable element according to the Fig. 1 to 10.

[0054] 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.

[0055] In a preferred embodiment, the socket of the sterile connector according to the invention has one to ten return 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, return elements.

[0056] 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.

[0057] 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 the Fig. 1 to 10.

[0058] 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).

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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 plate, a sealing ring and an inner seal, in particular at least one component of the at least one channel closure system according to the Fig. 1 to 10.

[0064] 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 has or consists of a heat-resistant material, wherein the heat-resistant material is a plastic.

[0065] 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 are in full contact with each other and define a contact surface of the plug receptacle and the plug head, and the side wall surfaces are in full contact with each other or the side wall surfaces are not in full contact with each other.

[0066] 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.

[0067] Preferably, the sterile connector according to the invention is designed such that the components to be heated do not come into contact with the medium being transported, in particular the liquid being transported, during sterilization. This preferably prevents damage to the medium being transported, especially the liquid being transported.

[0068] In a preferred embodiment, the components with surfaces that potentially come into contact with the environment, in particular potentially contaminated surfaces, are made of a heatable material or an inductively heatable material.

[0069] In a preferred embodiment, the components that have surfaces coming into contact with the environment before sterilization comprise, and in particular consist of, a heatable and / or inductively heatable material. Preferably, the components that have surfaces coming into contact with the medium to be transported after sterilization also comprise, and in particular consist of, a heatable and / or inductively heatable material. Preferably, the components that have surfaces coming into contact with the environment before sterilization and surfaces coming into contact with the medium to be transported after sterilization—both also referred to as potentially contaminated or sterilizable surfaces—comprise, and in particular consist of, a heatable and / or inductively heatable material.

[0070] In a preferred embodiment, potentially contaminated surfaces, i.e., surfaces to be sterilized, are sealed off from the environment by at least one seal to prevent contamination. This ensures that all surfaces of the sterile connector according to the invention that come into contact with the environment and / or come into contact with the medium to be transported after sterilization can be sterilized.

[0071] 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 or sterilizable surfaces—are sterilized. Sterilization of the surfaces defining the contact area is achieved by inductive heating.

[0072] Preferably, a sterile connector according to the invention is provided by sterilizing the surfaces to be sterilized, wherein only the 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 are not intended to come into contact with the environment before, during, or after the connection of the socket and plug, but are intended to come into contact 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 come into contact only with the medium to be transported, in particular the components forming the surfaces or a surface 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 area in the inserted state are heatable and / or inductively heatable such that all surfaces defining the contact area 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 which are not intended to come into contact with the environment are sealed by at least one seal so that they cannot come into contact with the environment.

[0073] In a preferred embodiment, the at least one return element is a spring system.

[0074] In a preferred embodiment, the at least one return element is a spring system and is configured to open the channel closure system of the socket and the plug when compressed, particularly by the at least one longitudinally displaceable element of the socket and / or the plug, especially 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. Preferably, the sterile connector according to the invention is in an open state due to the fluid connection that has been established.

[0075] In a preferred embodiment, the sterile connector according to the invention has a foldable sealing sleeve, in particular made of an elastic material, formed on the plug.

[0076] 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 an externally applied magnetic force.

[0077] In a preferred embodiment, the sterile connector according to the invention has a magnetic system, in particular formed on the socket or the plug, wherein the magnetic 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 located outside on the socket or on the plug and the at least one first or second magnet or at least one magnetic material is located inside the socket or the plug, in particular both at the same height on the longitudinal axis of the socket or the plug, in particular on the connection area side to the at least one longitudinally displaceable element, such that the at least one longitudinally displaceable element is longitudinally displaceable by the magnetic system.

[0078] In a preferred embodiment, the magnetic material comprises or consists of neodymium or iron.

[0079] 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.

[0080] In a preferred embodiment, the magnet outside the socket or plug is an electric lifting magnet, wherein a displacement can be controlled via electrical signals.

[0081] 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, especially an induction coil. In a preferred embodiment, an alternating voltage is applied to the inductive heating device, in particular the coil, especially the induction coil. Preferably, this inductively heats and sterilizes the inductively heatable components of the sterile connector according to the invention that are located in the inductive heating device and comprise the inductively heatable material.

[0082] 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.

[0083] 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.

[0084] 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 the Fig. 1 to 10.

[0085] 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.

[0086] 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 the Fig. 1 to 10.

[0087] In a preferred embodiment, the first and / or the second closed system is a vessel, in particular a bottle, in particular a crimped 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 an arbitrarily complex closed system.

[0088] In another aspect, the present invention relates to a method for sterilely connecting a first closed system to a second closed system, comprising the following process steps: a) Providing a first and a second closed system, wherein these are reversibly or integrally connected to a socket or plug of at least one sterile connector according to the invention and to a device for inductive heating, b) Bringing together the socket and plug of the at least one sterile connector in the inserted state, in particular so that 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, c) Inductive heating of the sterile connector, in particular of at least a part of the contact surface of the connector head and / or the connector receptacle, to a temperature and for a time sufficient to sterilize 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 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.

[0089] Preferably, the sterile connector according to the invention is in a separated state in process step a).

[0090] In a preferred embodiment, in process step b) of the inventive method, the socket and the plug of the at least one sterile connector are brought together in the inserted state such that the end faces and optionally the side wall 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.

[0091] Preferably, in process step b), the receptacle of the socket and the plug head of the plug of the at least one sterile connector according to the invention are positioned so that their end faces and, optionally, side wall surfaces are in full contact with one another, defining a contact surface of the receptacle and the plug head. Preferably, the sterile connector according to the invention is in a plugged-in state due to the full contact of the end faces and, optionally, the side wall surfaces of the receptacle and the plug head in process step b). Preferably, at least a part of the surface of the receptacle defining the contact surface and / or at least a part of the surface of the plug head defining the contact surface is inductively heatable, such that the entire surface defining the contact surface is heatable.

[0092] Preferably, in process step c), the inductively heatable portion of the contact surface defining the plug head and / or plug receptacle is inductively heated to a temperature and for a time sufficient to sterilize the contact surface, such that the entire contact surface defining the plug receptacle and plug head is heated. Advantageously, all contaminants, particularly biological contaminants, on the contact surface defining the plug receptacle and plug head are killed and / or destroyed. Thus, preferably, the entire contact surface defining the plug receptacle and plug head of the sterile connector according to the invention is sterilized in process step c).

[0093] In a preferred embodiment, in process step c) the inductively heatable part of the surface defining the contact area of ​​the plug head and / or the plug receptacle 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.

[0094] In a preferred embodiment, in process step c) the inductively heatable part of the surface defining the contact area of ​​the plug head and / or the plug receptacle 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.

[0095] 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 socket of the at least one sterile connector, in particular the socket of the at least one sterile connector, is carried out in method step d) by means of magnetic force, in particular by means of a ring magnet or an electric lifting magnet.

[0096] In a preferred embodiment, in the inventive method, after process step c) and before the transport of the liquid from the first and / or second closed system, the sterile connector, in particular at least part of the surface of the plug head and / or the plug receptacle defining the contact area, is cooled in a process step c1), in particular by rinsing or by air.

[0097] Preferably, after process step c) and before process step d), in a process step c1), the heated surfaces are allowed to cool down to a temperature compatible with the liquid to be transferred, in particular to 20 to 37 °C, especially 37 °C.

[0098] In a preferred embodiment of the inventive method, the opening of the channel closure system of the socket and plug of the at least one sterile connector is carried out in process step d) by moving 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 process step d). Preferably, in process step d), the respective channels of the socket and plug are connected to each other for the transport of a liquid from a first closed system or a second closed system to the other closed system.

[0099] Preferably, the closed systems, which are sterilely connected using a sterile connector according to the invention, are separated from one another in a process step e), in particular by pulling the plug out of the socket, especially the plug head of the plug out of the plug receptacle of the socket, of the sterile connector according to the invention. Preferably, in process step e), the at least one longitudinally displaceable element and the at least one compressed return element, which were displaced during opening according to process step d), are returned to their initial position. Preferably, the establishment of a fluid connection according to process steps b) to e) with the sterile connector according to the invention is reversible. Preferably, process 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.

[0100] In a further aspect, the present invention relates to a device for connecting, in particular automatically and sterilely, a first closed system with a second closed system, in particular by means of a method according to the invention, comprising - at least one sterile connector according to the invention, - a first closed system connected to the socket or plug of the at least one sterile connector, in particular integrally or reversibly, - a second closed system connected to the socket or plug of the at least one sterile connector, in particular integrally or reversibly, and, optionally, - at least one device for inductive heating.

[0101] In a preferred embodiment, the device according to the invention further comprises - a linear unit, in particular a motorized 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 one part of the first or second closed system.

[0102] Preferably, the first or second closed system is located entirely on the linear unit, including either the socket or the plug of the at least one sterile connector.

[0103] Preferably, at least one part of the first or second closed system located on the linear unit is a hose.

[0104] It is advantageous that the sterile connection of a first closed system with a second closed system is automated by the motorized linear unit in the device according to the invention.

[0105] 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 plug of the at least one sterile connector, in particular around the socket or plug of the at least one sterile connector which is fixed to the mounting.

[0106] In a preferred embodiment of the device, the linear unit, in particular a motorized one, is a force-driven mechanical guide and has a movable slide on which the socket or plug of the at least one sterile connector can be fixed, and wherein the device further has a control unit which can carry out the connection between the socket or plug of the at least one sterile connector located on the linear unit and the socket or plug of the at least one sterile connector fixed to the mounting.

[0107] 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.

[0108] In another aspect, the present invention relates to a method for the sterile transfer of biologically active media comprising the following process steps: a) Providing a first and a second closed system, wherein these are reversibly or integrally connected to a socket or plug of at least one sterile connector according to the invention and either the first and / or the second closed system includes a biologically active medium, and a device for inductive heating, b) Bringing together the socket and plug of the at least one sterile connector in the inserted state, in particular so that 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, c) Inductive heating of the sterile connector, in particular of at least a part of the contact surface of the connector head and / or the connector receptacle, to a temperature and for a time sufficient to sterilize 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 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.

[0109] In a preferred embodiment, in process step b) of the inventive method, the socket and the plug of the at least one sterile connector are brought together in the inserted state such that the end faces and optionally the side wall 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.

[0110] Preferably, in process step b), the receptacle of the socket and the plug head of the plug of the at least one sterile connector according to the invention are positioned so that their end faces and, optionally, side wall surfaces are in full contact with one another, defining a contact surface of the receptacle and the plug head. Preferably, the sterile connector according to the invention is in a plugged-in state due to the full contact of the end faces and, optionally, the side wall surfaces of the receptacle and the plug head in process step b). Preferably, at least a part of the surface of the receptacle defining the contact surface and / or at least a part of the surface of the plug head defining the contact surface is inductively heatable, such that the entire surface defining the contact surface is heatable.

[0111] In a preferred embodiment of the method, after process step c) and before the transport of the biologically active medium from the first and / or second closed system, the sterile connector, in particular at least part of the surface of the connector head and / or the connector receptacle defining the contact area, is cooled to a temperature compatible with the biologically active medium, in particular below 37 °C, in a process step c1).

[0112] In a preferred embodiment of the method according to the invention, the biologically active medium comprises at least one, in particular one, biologically active material and at least one, in particular one, biologically compatible liquid or at least one, in particular one, biologically compatible gas, in particular consists thereof.

[0113] 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.

[0114] 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.

[0115] 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.

[0116] In a preferred embodiment of the inventive method 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 of the following, wherein the method comprises the following process steps: a) Providing a first and a second closed system, wherein these are reversibly or integrally connected to a socket or plug of at least one sterile connector according to the invention, and either the first and / or the second closed system comprises 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 together the socket and plug of the at least one sterile connector in the inserted state, in particular so that 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, c) Inductive heating of the sterile connector, in particular of at least a part of the contact surface of the connector head and / or the connector receptacle, to a temperature and for a time sufficient to sterilize 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 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.

[0117] In another aspect, the present invention also relates to the use of a sterile connector or a device according to the invention for the sterile connection of a first closed system with a second closed system.

[0118] In a preferred embodiment, a use according to the invention is one in which two closed systems need to be connected to each other, particularly in medical technology, pharmaceutical production, cancer therapy or immunotherapy, especially for cancer.

[0119] Preferably, in an inventive use, the use of cleanrooms can be dispensed with, or, compared to known applications, cleanrooms with a lower degree of cleanliness, in particular according to DIN EN ISO 14644, can be used.

[0120] In the context of the present invention, the term "closed system" is understood to mean a system that exchanges only gaseous matter, and in particular no matter at all, with its surroundings. Preferably, a closed system does not exchange any solid or liquid matter with its surroundings. Preferably, no contamination can penetrate a closed system.

[0121] In connection with the present invention, the term "socket" is understood to mean a component, in particular a sleeve, having a cavity for receiving a plug. Preferably, "socket" refers to the female component of a plug connection. Preferably, a mechanical connection between the socket and the plug is established by receiving the plug in the cavity provided for this purpose in the socket. Preferably, the cavity of the socket is also referred to as the plug receptacle. Preferably, the plug receptacle is defined by the space enclosed by the end face and the surface of the side wall surfaces of the plug receptacle. Preferably, the plug receptacle is the part of the socket that encloses the plug, in particular the plug head. Preferably, a socket according to the present invention is a socket according to the Fig. 1 to 10 understood. Preferably, the plug receptacle serves for contacting, in particular for full-surface contact, the end face of the plug receptacle and the end face of the plug head of the sterile connector according to the invention.

[0122] In connection with the present invention, the term "plug" is understood to mean a component that is inserted into a socket to establish a mechanical connection. Preferably, "plug" refers to the male component of a plug connection. Preferably, a plug has a plug head that is enclosed by the plug receptacle of a socket. Preferably, the plug head has an end face and side wall surfaces. Preferably, a plug according to the present invention is a plug according to the Fig. Understood 1 to 10.

[0123] In the context of the present invention, the term "end face" is understood to mean a frontal surface formed by at least one component. Preferably, the end face is formed by the surface of the at least one component forming the end face. Preferably, the end face is flat. Preferably, the end face—viewed in longitudinal section of the connector receptacle or connector head—is arranged at an angle, particularly perpendicular, to the side wall surfaces. Preferably, the end face is continuous, i.e., without interruption, so that when two end faces are in full contact, no chamber, particularly no cavity, is formed.

[0124] 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 furthest distally, i.e., furthest away from the connection area of ​​the connector, in the longitudinal direction of the connector. Preferably, the end face of the connector receptacle serves for contacting the end face of the connector head.

[0125] 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.

[0126] Preferably, an end face of the connector receptacle or connector head according to the present invention is provided below an end face of the connector receptacle or connector head according to the Fig. 1 to 10 are understood. Preferably, the end faces of the connector receptacle and the connector head can also be non-flat, for example concave, convex, or wavy, or have any other possible shape, wherein the other end face is then formed as the negative form of the other end face, i.e., such that when the two end faces come into contact, they are in full contact, in particular the entire surfaces of the end faces are in full contact. Preferably, for example, if the end face of the connector receptacle has a concave shape, the end face of the connector head is formed in a convex shape such that it forms the negative form of the concave shape.

[0127] Preferably, the component forming at least one end face constructs an end wall.

[0128] In connection with the present invention, the term "side wall surface" is understood to mean a wall surface of the connector head or connector receptacle formed by at least one component and adjacent to an end face, preferably adjacent to the peripheral circumference of the end face. Preferably, the side wall surface – viewed in longitudinal section of the connector receptacle or connector head – is arranged at an angle, in particular perpendicular, to the end face. Preferably, all side wall surfaces facing the cavity of the connector receptacle and the end face of the connector receptacle enclose the side wall surfaces and the end face of the connector head of the sterile connector according to the invention.

[0129] Preferably, the component forming at least one side wall surface constructs a side wall.

[0130] In connection with the present invention, the terms “heatable end surface”, “inductively heatable end surface”, “heatable side wall surface” and “inductively heatable side wall surface” are understood to mean that the components forming the respective surfaces, in particular their surfaces, or the surface coating of the components forming the respective surfaces are made of inductively heatable or heatable material and thus the respective surfaces are heatable or inductively heatable.

[0131] 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 touching, of at least two real surfaces. Preferably, the two real surfaces in mutual contact 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 full-surface contact, in particular direct contact between the surfaces, especially the end faces and, optionally, the side wall surfaces of the socket and plug of the sterile connector according to the invention.

[0132] In connection with 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 enables a fluid connection between a first and a second closed system by reversible actuation. 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 plug of a sterile connector according to the invention in a closed state of the sterile connector according to the invention. Preferably, the respective channel of the socket and plug of the sterile connector according to the invention is opened by actuating the channel closure systems, thereby enabling a fluid connection between a first and a second closed system.Channel closure systems are preferably designed to form or close a fluid connection between the first and the second closed system.

[0133] In the context of the present invention, the term "reset element" is understood to mean an element that is functionally connected to a channel closure system of the sterile connector according to the invention such that, in the resting state of the reset element, the channel closure system closes the channel of the socket or plug. Preferably, the reset element is a spring that is compressed to a state other than its resting state. Preferably, a reset element is activated by an external force.

[0134] In the context of the present invention, the term "longitudinally displaceable element" is understood to mean 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.

[0135] In the context of the present invention, the term "made of inductively heatable material" means, for example, that a component which is made of inductively heatable material contains inductively heatable material or consists of inductively heatable material.

[0136] In connection with the present invention, the term ‘magnetic system’ is understood to mean a system consisting of a permanent magnet or an electromagnet and at least one magnet or magnetic material functionally related thereto.

[0137] In connection with 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 virtually no contamination, in particular from the environment, can reach the contact surface.

[0138] In connection with 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 virtually no contamination, in particular from the environment, can enter the channels.

[0139] In the context of the present invention, the terms "inside" and "inner" are understood to mean a component located further inside a sterile connector according to the invention, i.e., closer to a channel, and relating to an outer component. Preferably, an inner component does not come into contact with the surroundings of the sterile connector according to the invention.

[0140] In the context of the present invention, the terms "outer" and "external" are understood to mean a component located further outwards in a sterile connector according to the invention, i.e., closer to a housing arranged peripherally to the interior, in relation 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 disconnected state of a sterile connector according to the invention, contaminants are present on an outer component, in particular on its outward-facing surface.

[0141] In connection with the present invention, the terms "front, anterior, forward" are understood to mean a component located further forward in a sterile connector according to the invention, i.e. closer to an end face, in relation to a rear component.

[0142] In connection with the present invention, the terms "rear" and "rear" are understood to mean a component located further back in a sterile connector according to the invention, i.e. closer to a connection area, in relation to a front component.

[0143] In the context of the present invention, the term "separated state" is understood to mean a state of the sterile connector according to the invention in which the socket and plug do not touch. Preferably, "separated state" is understood to mean a state in which no contact surface is formed.

[0144] In the context of the present invention, the term "non-disconnected state" is understood to mean a plugged-in, connected or open state of the sterile connector according to the invention.

[0145] In the context of the present invention, the term "inserted state" refers to a state of the sterile connector according to the invention in which the plug head is located in the plug receptacle and the end faces of the plug receptacle and the plug head are in full contact with each other, defining a contact surface of 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 each other, are not subjected to any force in the inserted state.

[0146] In the context of the present invention, the term "not plugged in state" is understood to mean a disconnected, connected or open state of the sterile connector according to the invention.

[0147] In connection with the present invention, the term "connected state" is understood to mean a state of the sterile connector according to the invention in which the plug head is 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.

[0148] In connection with the present invention, the term "unconnected state" is understood to mean a disconnected, plugged-in or open state of the sterile connector according to the invention.

[0149] In connection with 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 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.

[0150] In the context of the present invention, the term "unopened state" is understood to mean a disconnected, inserted or connected state of the sterile connector according to the invention.

[0151] In the context of the present invention, the term "medium to be transported" is understood to mean a medium that is transported, i.e., transferred, between a first closed system or a second closed system to the other closed system by means of a sterile connector according to the invention. Preferably, the medium to be transported comprises a gas or a liquid. More preferably, the medium to be transported is 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 single substance, and in particular a biologically compatible liquid.

[0152] In the context of the present invention, the term "biologically active medium" is understood to mean a medium comprising, and in particular consisting of, at least one biologically active material, a biologically compatible liquid, a biologically compatible gas, or a combination thereof. Preferably, a biologically active medium is understood to be a medium endowed with desired chemical and / or biological activities, for example, enzymatic, catalytic, or cell-bound activities. Preferably, a biologically active medium is thermo- or UV-sensitive. Preferably, a biologically active medium is not a contaminant, i.e., not an undesirable material, and in particular not a biological system, i.e., not an impurity.

[0153] Preferably, the biologically active medium is thermolabile, particularly at temperatures above 37 °C. Preferably, the biologically active media according to the present invention are media to be transferred from a first closed system to a second closed system. Preferably, the biologically active media are not contaminants originating from the environment of the sterile connector according to the invention.

[0154] 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.

[0155] The cells are preferably immune cells, especially human immune cells.

[0156] 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.

[0157] Preferably, the biologically compatible gas is selected from the group consisting of nitrogen, a noble gas, in particular argon, oxygen and carbon dioxide.

[0158] In the context of the present invention, "biologically active medium-compatible temperature" is understood to mean a temperature at which the biological activity of the biologically active medium is not negatively affected, in particular not impaired. Preferably, a biologically active medium-compatible temperature is below 37 °C, particularly between 20 and 37 °C.

[0159] In the context of the present invention, "biologically active" is understood to mean a chemical and / or biological activity, for example, enzymatic, catalytic, or cell-bound activity, of a medium. Preferably, biologically active materials elicit a reaction in another biological material, particularly in a living organism. Preferably, biologically active materials are incorporated into or modified within another biological material, particularly in a living organism.

[0160] In the context of the present invention, the term "contamination" refers to the presence of unwanted materials, also known as impurities, originating from the environment, particularly biological systems, especially microorganisms, for example spores, bacteria, bacilli, fungi, viruses or viroids, RNA or DNA, on a surface of the sterile connector. Preferably, contaminants can be removed, in particular killed and / or destroyed, by inductive heating.

[0161] In the context of the present invention, the term "sterile connection" is understood to mean a connection established between two or more closed systems that enables the transport of a medium, in particular a liquid, from one of the two systems to the other, and wherein the sterile connection does not alter the closure of these systems, or only insignificantly, 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 of the closed systems may be sterile.

[0162] In the context of the present invention, the term "fluid connection" is understood to mean a connection between two systems that enables the transport of a medium, in particular a liquid, located in one of the two systems into the other. A fluid connection between two systems, particularly closed systems, is preferably established as soon as it is possible to transport media located in one system into the other via a sterile connector according to the invention, which is in the open state and connected to both systems.

[0163] In connection with the present invention, the term "inductively heatable" is understood to mean a property of a material which is characterized by the fact 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.

[0164] In the context of the present invention, the term "heatable" is understood to mean a property of a material characterized by the fact that the material is heated by heat transfer from another material having a higher temperature, i.e., has a higher temperature than before the heat transfer. Preferably, a heatable material cannot be heated inductively.

[0165] In the context of the present invention, the term "heat-resistant" is understood to mean a property of a material characterized by the fact that it cannot be heated to a temperature above 37 to 100 °C, particularly 37 °C, particularly 30 °C, particularly 25 °C, either by inductive heating or by heat transfer from another material having a higher temperature, particularly within 15 minutes. Preferably, a heat-resistant material cannot be heated to a temperature range of 30 to 100 °C, particularly 50 to 100 °C, particularly 30 to 60 °C, particularly by an inductively heated material, particularly within 5 to 30 minutes, particularly 10 to 15 minutes, particularly 15 minutes. Preferably, a heat-resistant material cannot be heated to the temperature of an inductively heated material, particularly by the inductively heated material.

[0166] In the context of the present invention, the term "at least one" is understood to mean a quantity that expresses a number of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and so on. In a particularly preferred embodiment, the term "at least one" can represent exactly the number 1. In another preferred embodiment, the term "at least one" can also mean 2, 3, 4, 5, 6, or 7.

[0167] Insofar as the “presence”, “containing”, “exhibiting” or “content” of a component is expressly mentioned or implied in connection with the present invention, this means that the respective component is present, in particular in a measurable quantity.

[0168] In the context of the present invention, the term "and / or" means that all members of a group connected by the term "and / or" are disclosed both alternatively to one another and cumulatively to 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).

[0169] In the context of the present invention, the terms "comprising" and "comprising" are understood to mean that, in addition to the elements explicitly covered by these terms, further, unmentioned elements may be present. 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 "comprising" is synonymous with the term "consisting of." Furthermore, the terms "comprising" and "comprising" also encompass compositions that, in addition to the explicitly mentioned elements, contain further unmentioned elements that are, however, of a functionally and qualitatively subordinate nature. In this embodiment, the terms "comprising" and "comprising" are synonymous with the term "essentially consisting of."The term "consisting of" means that only the explicitly mentioned elements are present and the presence of further elements is excluded.

[0170] Further embodiments of the present invention are the subject matter of the dependent claims and further independent claims.

[0171] The invention is explained in more detail with reference to the following examples and the accompanying figures.

[0172] The figures show: Fig. 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), Fig. 2 a longitudinal section of a first embodiment of a sterile connector according to the invention comprising a socket (1) and a plug (2) in a separated state, Fig. 3 a longitudinal section of a first embodiment of a sterile connector according to the invention comprising a socket (1) and a plug (2) in an inserted state, Fig. 4 a longitudinal section of a first embodiment of a sterile connector according to the invention comprising a socket (1) and a plug (2) in a connected state, Fig. 5 a longitudinal section of a first embodiment of a sterile connector according to the invention comprising a socket (1) and a plug (2) in an open state, Fig. 6 a) a second embodiment of a sterile connector according to the invention comprising a socket (102), a plug (103) and a magnetic 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 magnetic system formed on the socket (102) and an induction coil (104), Fig. 7 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 magnetic system (101, 111) formed on the socket (102) in a separated state, Fig. 8 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 magnetic system (101, 111) formed on the socket (102) in a separated state, Fig. 9 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 magnetic system (101, 111) formed on the socket (102) in a plugged-in state, Fig. 10 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 magnetic system (101, 111) formed on the socket (102) in an open state. REFERENCE MARK LIST A Connection area of ​​the socket B channel of the socket C channel of the connector D Connection area of ​​the plug 1 socket 2 plugs 3 Induction coil 4 Connection component of the socket 5 socket housings 6 Outer return spring of the bushing 7 pestles 8 Front ring of the socket 9 Inner seal of the front ring of the bushing 10 Outer seal of the front ring of the bushing 11 Rear seal of the connector receptacle 12 Front seal of the connector receptacle 13 Inner return spring of the bushing 14-channel component of the socket 15 Seal of the plunger 16 Sealing ring of the bushing channel 17 Front window of the socket 18 Front panel of the connector 19 Front seal of the plug 20 Front cover of the connector 21 Connecting channel component 22 Inner seal of the plug 23 connector housings 24 Mounting cover of the plug 25 sealing grommets 26-channel component of the connector 27 Return spring of the plug 28 Rear seal of the connector 29 Connector component of the plug 101 Ring magnet 102 socket 103 plugs 104 Induction coil 105 Connection component of the socket 106 Magnetic cover of the socket 107 plungers of the bushing 108 socket housings 109 Front window of the socket 110 Sterilization sleeve of the socket 111 Inner magnet of the socket 112 Pushrod holder of the bushing 113 Bushing return spring 114 Bushing sealing ring 115 Front window of the connector 116 Front housing part of the connector 117 Inner seal of the plug 118 Outer seal of the plug 119 Plug plunger 120 Plug return spring 121 Connector component of the plug Example 1

[0173] In Fig. Figure 1 shows an external view of 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). The socket (1) and the induction coil (3) are on the left side and the plug (2) on the right side of the Fig. 1 shown separately, i.e., in a separate 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 inserted into the interior of a coil (3), whereby the plug head of the plug is pushed into the plug receptacle of the socket until the respective end faces are in full contact with each other, whereby the sterile connector according to the invention is in a plugged-in state.

[0174] In the Fig. Figures 2 to 5 show a first embodiment of a sterile connector (1) according to the invention, consisting of a socket (1) and a plug (2), in longitudinal section. Fig. Figure 2 shows a first embodiment of a sterile connector according to the invention in a separated state. Fig. Figure 3 shows a first embodiment of a sterile connector according to the invention in an inserted state. Fig. Figure 4 shows a first embodiment of a sterile connector according to the invention in a connected state. Fig. Figure 5 shows a first embodiment of a sterile connector according to the invention in an open state. The following sections describe the embodiment of the connector. Fig. Sections 2 to 5 describe 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.

[0175] The socket (1) has a connection area (A) for a first or second closed system and a connector receptacle configured for receiving a plug head. A first or second closed system, such as a hose from 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 hose section. The connection area (A) is formed by a connecting component of the socket (4). Preferably, the connecting component of the socket (4) is glued into a socket housing (5), or the connecting component of the socket (4) and a first part of the socket housing (5) are formed from a single component, in which case the socket housing (5) consists of two parts.

[0176] The connector receptacle has side wall surfaces formed by three components: the socket housing (5), a rear socket seal (11), and a front socket seal (12). It also has an end face formed by two components: a socket front ring (8) and a socket front disc (17). The socket housing (5) contains all the socket components. The socket front ring (8) and the socket front disc (17) are made of an inductively heatable material.

[0177] 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 via the channel (B). Fig. 5).

[0178] The connector (2) 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 hose from 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 hose section. The connection area (D) is formed by a connecting component of the connector (29). The connector head has side wall surfaces formed by two components, namely a front shell of the connector (20) and a connecting channel component (21), and an end face of the connector head formed by two components, namely a front disc of the connector (18) and a front shell of the connector (20).The front disc of the plug (18) is made of inductively heatable material. The front housing of the plug (20) is made of inductively heatable material and, while heated in the inserted state, sterilizes the inner wall of the socket in the plug receptacle (. Fig. 3) The connecting channel component (21) is inserted into the interior of the socket before the sterile connector according to the invention is opened and, together with other components, enables the transfer 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 when the sterile connector according to the invention is open ( Fig. 4 and Fig. 5) Furthermore, the connector (2) has a channel (C) extending from the terminal area (D) of the connector to the connector head. The channel (C) of the connector is formed by a channel component (26) and the terminal component of the connector (29) and is made of a heat-resistant material. The medium to be transported is guided through the connector via the channel (C). Fig. 5).

[0179] The channels of the socket and the plug (B, C) each have a reversible channel closure system in the end face of the respective channel, namely a plunger (7) with respect to the socket and a connecting channel component (21) with respect to 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) in the closed state of the sterile connector according to the invention by being pressed against a sealing ring of the channel (16) by the inner return spring of the socket (13) in the closed state. Fig. 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, together with other components, enables the transfer of a medium to be transported in a first or second closed system to the respective other system between plug and socket when the sterile connector according to the invention is open ( Fig. 5).

[0180] The outer and inner return springs of the socket (6, 13) are functionally connected to four longitudinally displaceable elements relative to the channel (B), namely the plunger (7), the front ring of the socket (8), an inner seal of the front ring of the socket (9), and a seal of the plunger (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 cover 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).

[0181] The outer return spring of the socket (6) presses the front ring of the socket (8) against the socket housing (5). When the longitudinally displaceable elements, in particular the front housing of the plug (20), are inserted into the socket, the outer return spring of the socket (6) is compressed by the front ring of the socket (8). Fig. 4 and Fig. 5) In the last part of this compression of the outer return spring of the bushing (6), the front ring of the bushing (8) is pressed against the plunger (7) and the plunger (7) is moved in the direction of the connection area of ​​the bushing (A), whereby the sterile connector according to the invention is in an open state ( Fig. 5).

[0182] The inner return spring of the bushing (13) presses the plunger (7) against a sealing ring of the channel of the bushing (16), thereby sealing the channel (B) and keeping the sterile connector according to the invention in a closed state. By moving the front ring of the bushing (8) towards the connection area of ​​the bushing (A), the plunger (7) compresses the inner return spring of the bushing (13) until the sterile connector according to the invention is in the open state. Fig. 4 and Fig. 5) The sealing ring (16) prevents liquids from entering the channel (B) between the plunger (7) and the front disc of the bushing (17) when separated.

[0183] The return spring of the connector (27) enables the front seal of the connector (19), the front housing of the connector (20), the connecting channel component (21), the inner seal of the connector (22), the connector housing (23), the mounting cover of the connector (24), and a rear seal of the connector (28) to be pushed back into their initial position after the relative movement towards the connection area (A) of the socket, thus closing the connector (2), i.e., the sterile connector according to the invention is in a closed state. The connector housing (23) forms the outer shell of the connector in relation to the connector in the socket. Fig. The connector head (24) is located on the left side of the right part of the connector. After all internal components of the connector have been assembled, the connector mounting cover (24) is glued into the connector housing (23). The rear seal (28) of the connector seals the interior of the connector mounting cover (24) against the interior of a foldable sealing sleeve (25) and guides the movement of the connector's terminal component (29) into the connector mounting cover (24). The foldable sealing sleeve (25) is made of a flexible material and prevents contaminants from entering the interior of the connector (2) during the movement of the terminal component (29) into the connector mounting cover (24).

[0184] The first embodiment of the sterile connector according to the invention also features 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 respect to the socket, a seal of the plunger (15) and the sealing ring of the channel (16), and with respect 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 liquid from entering 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 closed. The sealing ring of the socket channel (16) prevents liquid from entering the environment from the channel (B) between the plunger (7) and the channel component (14) when the sterile connector according to the invention is closed, and prevents contamination from entering the interior of the channel (B) from the environment when the sterile connector according to the invention is disconnected and / or inserted, particularly before sterilization.The front seal of the plug (19) prevents liquid from escaping from the channel (C) into the environment between the front disc of the plug (18) and the front housing of the plug (20) when the sterile connector according to the invention is disconnected and / or plugged in, 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) into the interior 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 disconnected and / or plugged in, particularly before sterilization.

[0185] Furthermore, the socket has an outer seal of the front ring of the socket (10) which prevents contamination from entering the interior of the socket housing of the (5) between the socket housing (5) and the front ring of the socket (8) when the sterile connector according to the invention is disconnected and / or plugged in, especially before sterilization.

[0186] Based on the Fig. Figures 2 to 5 show a method according to the invention for sterilely connecting a first closed system to a second closed system using a first embodiment of the sterile connector according to the invention.

[0187] In a first process step a), a first and a second closed system are provided, wherein these are reversibly or integrally connected to the connection areas of a socket (A) or a plug (D) of a sterile connector 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 Fig. 2. Subsequently, in a process step b), the socket (1) and the plug (2) of the at least one sterile connector are placed in the inserted state of the sterile connector according to the invention. Fig. 3. The plug head is inserted into the socket receptacle until the end faces of the plug and socket are in full contact, defining a contact surface between the receptacle and the plug head. The components forming the end face of the socket are the socket's front ring (8) and the socket's front disc (17), and the components forming the plug's end face are the plug's front disc (18) and the plug's front housing (20). Part of the components (8, 17, 18, 20) defining the contact surface of the plug receptacle and the plug head are inductively heatable, or they are entirely inductively heatable. If only part is inductively heatable, the remaining part of the components (8, 17, 18, 20) defining the contact surface of the plug receptacle and the plug head is heatable, such that all surfaces defining the contact surface are heatable.When the plug head is pushed into the plug receptacle, the plug is held at the connector component of the plug (29).

[0188] In process step c), the sterile connector according to the invention is inductively heated. The induction coil, which, when plugged in, surrounds the inductively heatable components (8, 17, 18, 20) of the socket and plug (2) outside of the socket (1) and plug, is energized. The magnetic field inside the induction coil heats the inductively heated part of the components (8, 17, 18, 20) and, through heat transfer between the inductively heated part and the heated part of the fully contacting 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 area, i.e., to render any possible contamination on the surface forming the contact area of ​​the components (8, 17, 18, 20) of the socket and plug biologically harmless.Once the desired temperature and time are reached, the current is switched off. Preferably, the required temperature is maintained for the required time. It is then preferably possible to wait until the heated components have cooled down to a temperature at which the medium being transferred is stable and therefore not damaged.

[0189] Then, in a process step d), the channel closure systems (7, 21) of the socket and plug of the at least one sterile connector are opened, thereby establishing a fluid connection between the first and second closed systems through the at least one sterile connector.

[0190] When the channel closure systems are opened according to process step d), the longitudinally displaceable elements of the plug are pushed into the socket. The sterile connector is in a connected state during this process. In the last part of this movement, the respective channels of the socket and the plug are fully opened, and the sterile connector according to the invention is in an open state.

[0191] 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 ( Fig. 4) Here, components (7), (8), (9), (15), (19), (20), (21), (22), (23), (24) and (28) are moved relative to their respective channels in the direction of at least one connection area (A) of the bushing. During this process, the return elements (6) and (27), which are designed as springs, are compressed. The elastic sealing sleeve (25) is stretched.

[0192] During the final part of this movement, the front ring of the bushing (8) strikes the plunger (7) and also moves it towards the at least one connection area (A) of the bushing. The return element (13), designed as a spring, is also compressed. This movement pulls the plunger (7) away from the sealing ring of the channel of the bushing (16), opening the channel (B) and the channel (C), so that the sterile connector according to the invention is in an open state. The liquid can then be discharged according to... Fig. 5 flow along the dashed line through the sterile connector according to the invention from one first or second closed system into the other closed system.

[0193] The connection is broken in the reverse order of the steps described, but without the heating step.

[0194] 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. Example 2

[0195] In Fig. 6 a) An external view of a second embodiment of a sterile connector according to the invention is shown, comprising a socket (102), a plug (103) and a magnet (101). The socket (102) and the magnet (101) are on the left side and the plug (103) on the right side of the Fig. 6 a) shown separately, i.e., in a separate state of the sterile connector according to the invention. The magnet is located on the left side of a tapered part of the socket. In Fig. Figure 6 b) shows a longitudinal cross-section of the socket and 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 inside the induction coil (104). For the sterilization process, the plug receptacle of the socket and the plug head of the plug are inserted into the interior of the coil (104). The plug head of the plug is pushed into the plug receptacle of the socket until the respective end faces are in full contact with each other, thereby placing the sterile connector according to the invention in a plugged-in state.

[0196] In the Fig. 7 and Fig. Figure 8 shows 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, side by side in a separated state of the sterile connector according to the invention in longitudinal section.

[0197] In the Fig. Figure 9 shows the first alternative of the second embodiment of the sterile connector according to the invention in an inserted state. Fig. Figure 10 shows the first alternative of the second embodiment of the sterile connector according to the invention in an open state. The following sections describe the... Fig. Sections 7 to 10 describe 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 with a first alternative of a second embodiment of the sterile connector according to the invention.

[0198] The socket (102) has a connection area (A) to the first or second closed system and a connector receptacle configured for receiving a connector head. A first or second closed system, such as a hose from 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 hose section. The connection area (A) is formed by a connecting component of the socket (105). Preferably, the connecting component of the socket (105) is glued to a socket housing (108), or the connecting component of the socket (105) and a first part of the socket housing (108) are formed from a single component, with the socket housing (105) then consisting of two parts. The connector receptacle of the first alternative according to Fig. 7 has side wall surfaces formed by one component, namely the sterilization sleeve of the socket (110), and an end face of the socket formed by one of two components, namely a front disc of the socket (109) and the sterilization sleeve of the socket (110). The plug receptacle of the second alternative according to Fig. Figure 8 has side wall surfaces formed by one component, namely the socket housing (108), and an end face formed by one of two components, namely the socket's front disc (109) and the socket's sterilization sleeve (110). The socket housing (108) is made of heat-resistant material. The socket's front disc (109) and the socket's sterilization sleeve (110) are each made of an inductively heatable material.

[0199] 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 cover of the socket (109) closes the channel (B). In the open state of the sterile connector according to the invention, the medium to be transported is guided through the socket via the channel (B). Fig. 10).

[0200] 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 hose from 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 hose section. The connection area (D) is formed by a connecting component of the connector (121), which is also a rear housing part of the connector. In the first alternative according to Fig. 7 The connector head has side wall surfaces formed by two components, namely a front housing part of the connector (116) and an outer seal of the connector (118), and an end face of the connector head formed by two components, namely a front window of the connector (115) and the front housing part of the connector (116). In the second alternative according to Fig. Figure 8 of the connector head comprises side wall surfaces formed by one component, namely the front housing part of the connector (116), and an end face formed by one of three components, namely the front disc of the connector (115), the outer seal of the connector (118), and the front housing part of the connector (116). The front disc of the connector (115) is made of inductively heatable material. The front housing part of the connector (116) and the outer seal of the connector (118) are made of heatable material. The outer seal of the connector (118) prevents contamination from entering the interior of the sterile connector according to the invention when it is plugged in and after heating. This contamination occurs between the sterilization sleeve of the socket (110) and the front housing part of the connector (116).The housing of the connector therefore consists of four parts, namely the front housing part of the connector (116), which together with the front window of the connector (115) and the outer seal of the connector (118) forms the connector head and the front part of the connector housing, and a rear housing part of the connector, namely the connector component (121).

[0201] In Fig. 7. In the first alternative of the second embodiment, both the components forming the end faces and side wall surfaces of the connector receptacle of the socket (109, 110) and one of the two components forming the end face of the connector head (115) are made of an inductively heatable material. The components forming the side wall surfaces of the connector head (116, 118), on the other hand, are made of a heatable material. When the surfaces of the end faces and side wall surfaces of the connector receptacle and the connector head are in full contact with each other, a contact surface is defined.The outer seal of the connector (118) is positioned on the surface of the component forming the side wall surfaces of the connector head (116), in particular at the transition from the respective side wall surface to the end face, such that when the two components are in full contact, especially when not separated, at least a part, in particular the entire, of the contact area defined by the end faces and side wall surfaces is enclosed peripherally on all sides by the outer seal of the connector (118) and no unwanted material, i.e. no contamination, reaches the surfaces to be heated, i.e. sterilized, enclosed by the outer seal of the connector (118).In such an embodiment, i.e., if at least the surfaces of either the connector receptacle or the connector head, the components forming the end face and side wall surfaces, and the surfaces of the components forming the end face of the other, are made of 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 a 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, to prevent the penetration into the interior, in particular into the channel, of the sterile connector according to the invention of unwanted materials, in particular contaminants, especially after the sterilization step.

[0202] In Fig. 8. In the second alternative of the second embodiment, both the components forming the end faces of the connector receptacle of the socket (109, 110) and one of the three components forming the end face of the connector head (115) are made of an inductively heatable material. The other two of the three components forming the end face of the connector head (116, 118) are made of a heatable material. The component forming the side wall surfaces of the connector receptacle (108) is made of a heat-resistant material. A contact surface is defined when the inductively heatable surfaces of the end faces of the connector receptacle and the connector head are in full contact with each other. The outer seal of the connector (118) is positioned on the surface of the component forming the end face of the connector receptacle (116) in such a way thatIn particular at the transition between one inductively heatable component (115) forming the end face of the connector head and the other inductively heatable component (116) forming the end face of the connector head, it is ensured that, when fully in contact, especially when not separated, at least a part, and in particular the entire, of the contact area defined by the end faces is enclosed on all sides by the outer seal of the connector (118), namely in particular at least the part which is formed of longitudinally displaceable elements, and that no unwanted material, i.e. no contamination, reaches the surfaces to be heated, i.e., sterilized, enclosed by the outer seal of the connector (118), in particular the front faces of the socket (109) and the connector (115). In such a design,Therefore, if the surfaces of the components forming the end faces of the connector receptacle and the connector head are made of 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, especially on at least a part of the part of the surfaces defining the contact area, particularly at the transition from the longitudinally displaceable part to the non-longitudinally displaceable part of the components forming the end face, is helpful, in particular necessary, to prevent the penetration into the interior, in particular into the channel, of the sterile connector according to the invention by unwanted materials, in particular contaminants, especially after the sterilization step.

[0203] Furthermore, the connector (103) has a channel (C) extending from the connector's terminal area (D) to the connector head. The channel (C) of the connector is formed by the front housing part of the connector (116) and the connector's terminal component (121). The connector's front cover (115) closes the channel (C). The medium to be transported is guided through the connector via the channel (C). Fig. 10).

[0204] The channels of the socket and the plug (B, C) each have a reversible channel closure system in the end face of the respective channel, namely the front disc of the socket (109) and a sealing ring of the socket (114) with respect to the socket, and the front disc of the plug (115) and an inner seal of the plug (117) with respect to the plug. The sealing ring of the socket (114) is made of heatable material and prevents contamination from entering the interior of the socket between the socket housing (108) and the front disc of the socket (109) when the sterile connector according to the invention is closed. Furthermore, the sealing ring of the socket (114) is designed such that, when the sterile connector according to the invention is closed, it makes contact with both the socket housing (108) and the sterilization sleeve of the socket (110).This ensures that all potentially contaminated areas are heated and, 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 connector (117) is made of heatable material and prevents contaminants from entering the interior of the connector between the front housing part of the connector (116) and the front cover of the connector (115) when the sterile connector according to the invention is not opened.

[0205] The reversible channel locking system of the socket (109, 114) is functionally connected to a return element, namely a return spring of the socket (113). The reversible channel locking system of the plug (115, 117) is functionally connected to a return element, namely a return spring of the plug (120).

[0206] The return spring of the socket (113) is functionally connected to six elements that are longitudinally displaceable with respect to the channel (B), namely a magnetic cover of the socket (106), a plunger of the socket (107), the front disc 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 disc of the plug (115), the internal seal of the plug (117), and a plunger of the plug (119).

[0207] In a closed state of the sterile connector according to the invention, the return spring of the bushing (113) pushes the plunger holder of the bushing (112) in relation to the channel (B) towards the connection area (A) of the bushing. This presses the sealing ring of the bushing (114) against the bushing housing (108). Fig. 7 and Fig. 8) The plunger holder of the socket (112) serves to connect the plunger of the socket (107) and the inner magnet of the socket (111). The plunger of the socket (107) is made of heat-resistant material and is moved indirectly by the inner magnet of the socket (111). The magnetic cover of the socket (106) prevents the medium being transported from coming into contact with the inner magnet of the socket (111). The magnetic cover of the socket (106) is optional if the inner magnet of the socket (111) is compatible with the medium being transported.

[0208] 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 is made of heat-resistant material, with the inner seal of the plug (117) in relation to the channel (D) towards the end face of the plug against the front housing part of the plug (116) ( Fig. 7 and Fig. 8).

[0209] The second embodiment of the sterile connector according to the invention also has a magnetic system formed on the socket (102) consisting of a ring magnet (101) and the inner magnet of the socket (111) ( Fig. 7 to 10). The ring magnet (101) is located on the outside of the socket, and the inner magnet of the socket (111) is located inside the socket, both being at the same height along the longitudinal axis of the socket, relative to the remaining longitudinally displaceable elements (106, 107, 109, 112, 114) on the connection side. The ring magnet (101) moves the inner magnet of the socket (111) inside the socket. This, in turn, displaces the remaining longitudinally displaceable elements of the socket (106, 107, 109, 112, 114). When the sterile connector according to the invention is plugged in, 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 moving the magnetic system (101, 111) towards the connection area of ​​the plug (D), and the respective spring system of the socket and the plug is compressed.As a result, the respective channel closure system of the socket and the plug no longer seals the socket and the plug, and a fluid connection is established between the first and the second closed system. The sterile connector according to the invention is in an open state.

[0210] Furthermore, the second embodiment has 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 the sealing ring of the socket (114) with respect to the socket and the inner seal of the plug (117) with respect to the plug.

[0211] Based on the Fig. 7, Fig. 9 and Fig. 10 A method according to the invention for sterilely connecting a first closed system with a second closed system is shown with the first alternative of a second embodiment of the sterile connector according to the invention.

[0212] In a first process step a), a first and a second closed system are provided, wherein these are 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 Fig. 7. Subsequently, in process step b), the socket (102) and the plug (103) of the at least one sterile connector are placed in the inserted state according to Fig. 9. The plug head is inserted into the socket receptacle until the end faces of the plug and socket are in full contact, defining a contact surface between the receptacle and the plug head. The components forming the end face of the socket are the socket's front disc (109) and the socket's sterilization sleeve (110), and the components forming the plug's end face are the plug's front disc (115), the plug's front housing part (116), and optionally the plug's outer seal (118).Part of the components (109, 110, 115, 116) defining the contact surface of the socket and plug are inductively heatable or they are completely inductively heatable, wherein, if only part is inductively heatable, the other part of the components (109, 110, 115, 116) defining the contact surface of the plug receptacle and plug head is heatable in such a way that the entire surfaces defining the contact surface are heatable.

[0213] In process step c), the sterile connector according to the invention is inductively heated. The induction coil, which, when plugged in, surrounds the inductively heatable part of the components (109, 110, 115, 116) of the socket and plug (103) outside of the socket, is energized. The magnetic field inside the induction coil heats the inductively heated part of the components (109, 110, 115, 116) and, through heat transfer between the inductively heated part and the heated part of the fully contacting surfaces of the components (109, 110, 115, 116), the heatable part of the components (109, 110, 115, 116) is heated to a temperature and for a time sufficient to sterilize the surfaces defining the contact area, i.e., to render any possible contamination on the surface defining the contact area of ​​the components (109, 110, 115, 116) of the socket and plug biologically harmless.Once the desired temperature and time are reached, the power is switched off. Preferably, one then waits until the heated components have cooled down to a temperature at which the medium being transferred is stable and therefore not damaged.

[0214] Then, in a process step d), the channel closure systems (109, 114, 115, 117) of the plug and socket of the at least one sterile connector are opened, thereby establishing a fluid connection between the first and second closed systems through the at least one sterile connector.

[0215] When opening the channel closure systems according to process step d), the longitudinally displaceable components of the socket and plug are pushed towards the connection area of ​​the plug using the magnetic system (101, 111) (D) ( Fig. 10). The sterile connector according to the invention is in an open state.

[0216] The components (106), (107), (109), (112), (114), (115), (117) and (119) are moved relative to the respective channels of the socket and the plug in the direction of at least one connection area (D) of the plug by means of the magnetic system (101, 111). In doing so, the return elements (113) and (120), which are designed as springs, are compressed.

[0217] 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. The liquid can then be discharged according to... Fig. 10 flow along the dashed line through the sterile connector according to the invention from one first or second closed system into the other closed system.

[0218] The connection is broken in the reverse order of the steps described, but without the heating step. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] EP 3 270 979 B1

[0006] EP 0 121 980 B1

[0007] US 11,090,478 B2

[0008]

Claims

[1] Sterile connector for sterile connection of a first closed system to a second closed system comprising: - having a bushing (1, 102) 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; - having a plug (2, 103) 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 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 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 frontal area of ​​the respective channel, which is functionally connected to at least one return element (6, 13, 27, 113, 120), wherein the at least one return element (6, 13, 27, 113, 120) is functionally connected to at least one element (7, 8, 9, 15, 19, 20, 21, 22, 23, 24, 28, 106, 107, 109, 111, 112, 114, 115, 117, 119) that is longitudinally displaceable with respect to the respective channel, 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 in contact area and / or at least one component (20, 21, 116, 118) forming the side wall surface of the plug head at least partially in contact area 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. [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 and is designed to open the channel closure system (7, 21, 109, 114, 115, 117) of the socket and the plug upon compression, 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 established via the channel (B) of the socket and the channel (C) of the plug 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] 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 lie against each other 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 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] 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] 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), cooling of the sterile connector, in particular of at least part of the surface of the plug head and / or the plug receptacle defining the contact surface, is carried out, 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 apparatus 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 can carry out 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) or the plug (2, 103) of the at least one sterile connector fixed to the fastening. [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] Process for the sterile transfer of biologically active media comprising the following process 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 each other 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 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] 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 part of the surface of the plug head and / or the plug receptacle defining the contact surface, to a biologically active medium-compatible temperature, in particular below 37 °C, is carried out.

Citation Information

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