Electromechanical aseptic isolation

Abstract

The present disclosure relates to a sterile separation element (1) for sterile separation, which is arranged between plug connectors (10, 11) of a plug connection / mechatronic gate (2) and thus provides sterile separation of the plug connectors (10, 11). The mechatronic gate (2) has at least one electrical contact pin (9), which individually passes through the sterile separation element (1) such that the sterile separation element (1) lies directly germ-proof completely against the at least one electrical contact pin (9), where the at least one electrical contact pin (9) has two free pin ends, which are arranged and configured for an electrical plug-in contact with corresponding electrical sockets (12) of at least two wires (5) to be connected.

Description

Technical Field

[0001] This disclosure relates to a sterile barrier having a covering element or separation element, such as a waterproof tarpaulin or film (also called a cover), and an electromechanical antimicrobial gate integrated therein or which can be integrated / installed therein for transmitting electrical energy and / or electrical control signals from wiring on the non-sterile side to wiring on the sterile side. Background Technology

[0002] The increasing digitalization of surgery has led to greater integration of electronics and software in electrically driven surgical motor systems. Because electronic components can only be fabricated at significant costs and cannot be made without restriction, the principle is to provide or separate, for example, surgical actuators, in a sterile area (where materials can be fabricated without restriction and operated on without restriction) and a non-sterile area (where critical materials are prepared and the surgeon cannot access them). The advantage of this approach is that the surgeon must handle the smallest possible mass (volume) as the main components of the surgical actuator are transferred to the non-sterile area. These two areas (sterile / non-sterile) must then be electromechanically in contact before surgery and, on the other hand, alternately non-contact / separated and re-contacting with other sterile areas during surgery. Ideally, this is performed by aseptic personnel at the operating table while maintaining aseptic requirements. This necessitates a sterile separation design that is adapted to current surgical hygiene requirements and capable of reliable operation.

[0003] Appendix Figure 3 The general arrangement of sterile and non-sterile areas separated by a sterile barrier and configured as described in this disclosure is shown.

[0004] For example, a robot 100, including an adjustment actuator or holding device, is situated in a non-sterile area U isolated from the surrounding sterile area S by means of a cover 101. This cover has at least two gates / openings 102 and 103, one gate 102 being configured as a through opening for the holding arm of the robot 100, and the other gate 103 being configured for connecting a sterile cable segment 104 in the sterile area S to a non-sterile cable segment in the non-sterile area U (not shown). A connection device 105 is provided for this purpose. In this case, the cable in the sterile area S is connected to, for example, a control unit 106 for manipulating the robot 100.

[0005] In principle, other application examples include contact between drive motors in sterile areas and control modules or robotic arms in non-sterile areas.

[0006] It is further known, for example, to install so-called shields on sterile motor cables. The shields are positioned to reduce the risk of contact with non-sterile components during connection / plugging processes, or when inserting the motor cable into a non-sterile control device. Such shields are also known as sterile caps.

[0007] However, its main drawback is that after a single connection / plug-in, the motor cable is contaminated at least within its connector area, and it is not possible to decouple / remove the cable and return it to the sterile instrument table in the sterile area. This prevents different drives from being used for different surgical procedures during surgery.

[0008] Furthermore, existing technologies include so-called sterile barriers in the form of covering or separating waterproof tarpaulins. These sterile barriers separate sterile and non-sterile areas and are equipped with ports or interfaces through which supply lines can be guided. For this purpose, such ports have a number of valves that can be opened and closed to selectively create corresponding channels.

[0009] US 2018 / 0 145 443A1 discloses an electrical connector configured for a movable and trackable electromagnetic tracking device within a patient's body. In this multi-piece electrical (plug-in) connector system used in a medical setting, a first segment of the connector system is arranged such that it penetrates a formable sterile barrier, such as a sterile barrier made of fibrous material, wherein this is achieved by coupling the first portion of the connector system to a second portion of the connector system. However, a disadvantage here is that, as understood particularly with reference to Figures 9, 11A, and 11E of US 2018 / 0 145 443A1, the proposed penetration allows (locally) unobstructed pathways for pathogens at the corresponding sites. Due to unimpeded contamination through the penetrated opening, adverse effects or the elimination of previously present sterility naturally occur.

[0010] US 2018 / 0 049 833A1 discloses a sterile barrier for use with a surgical robotic system. The sterile barrier may include a housing configured to engage with a tool manipulator connected to a robotic arm and to detachably house a surgical instrument. The housing of the sterile barrier has a sterile flexible fabric extending therefrom, such that the housing and the flexible fabric are constructed in more than one plane and define sterile and non-sterile sides, with the surgical instrument disposed on the sterile side and the tool disposed on the non-sterile side. The housing may have at least one pin-shaped contact configured to functionally engage with at least one complementary electrical contact on at least one of the tool manipulator and the robotic arm. Pre-formed openings are constructed in the fabric, arranged or configured to allow the pin-shaped contact to pass through these openings respectively.

[0011] US 2016 / 0 058 513A1 discloses another sterile barrier known in the prior art. Here, a surgical system includes a first element having a support that detachably houses surgical instruments for their operational use. At least one of two connectors, provided with electrical contacts for engagement with other connectors, is designed to be controllably movable between a first retracted rest position and a second forward position for electrical connection with the other connector.

[0012] Furthermore, the applicant's patent DE 20 2007 002 332 U1 discloses a medical sterile cover in which a plug contact is introduced into a corresponding socket through a corresponding opening provided in the housing. Here, for sealing purposes, a strong adhesive bonding is recommended. Summary of the Invention

[0013] Therefore, the objective of this disclosure is to avoid or at least reduce the disadvantages of the prior art. In particular, the electromechanical interface on the operating table for repeatedly fitting / separating sterile application parts from non-sterile operating parts should be reliable, hygienic, and / or simple and therefore inexpensive.

[0014] This task is accomplished by a sterile barrier according to this disclosure.

[0015] The core idea of ​​this disclosure is to provide a simple sterile separation element (sterile barrier) in the form of, for example, waterproof tarpaulin, film, or cloth, and an electromechanical gate / coupling portion having at least one contact pin arranged and configured such that, depending on the type of mandrel, the contact pin can be inserted into / pierced into the sterile separation element from one side, and protrude from the other side of the sterile separation element. This achieves that at least one contact pin is (indirectly / indirectly) sterilely surrounded by the sterile separation element, or the sterile separation element is sterilely surrounding and abutting against at least one contact pin, wherein the contact pin can make contact at at least one end / end segment of a wire, for example, by means of a socket or plug.

[0016] It should be noted that at least one contact pin may have two substantially identical / similar rod ends / pin ends, such that two identical / similar sockets having or composed of corresponding bushing-shaped / sleeve-shaped contact elements can be inserted from both sides. Alternatively, it is also conceivable to construct at least one contact pin with (two) distinct pin ends, particularly such that one end on the non-sterile side of the aseptic separation element is preferably constructed as a (small-diameter) pin, and the other end on the sterile side of the aseptic separation element is preferably constructed as a (large-diameter) sleeve / receptacle. In this way, a type of receptacle / socket with a (large-diameter) sleeve-shaped contact pin can be inserted / plucking into / on the contact pin penetrating the aseptic separation element on the (non-sterile) side, and a type of plug / insertion pin with a (small-diameter) pin shape can be inserted / plucking into / on the contact pin penetrating the aseptic separation element on the other (sterile) side. The latter offers the advantage that, for example, an electromedical device on the sterile side, typically equipped with a cable and a cable plug (with a pin-shaped electrical contact) fixedly arranged on the cable, can be electrically coupled to at least one contact pin (or its sleeve-shaped pin end) without the need for an additional (intermediate) adapter. The same applies to so-called extension cables on the non-sterile side, where the jacks on each end of the extension cable, along with at least one sleeve-shaped contact pin, can also be electrically coupled without an adapter to the pin end of at least one contact pin inserted into a sterile dissociation element, where the pin is shaped as a pin.

[0017] Preferably (alternatively or cumulatively), at least one contact pin is held in / by a first housing on one side of the sterile separation element, the first housing either forming a receiving sleeve for a socket and / or plug or leading out at least one wire fixed to at least one contact pin. It should also be noted that it is not necessary to arrange the same type of receiving sleeve or socket on both sides of the sterile separation element; rather, it is also possible to arrange the plug on one side, preferably the non-sterile side, of the sterile separation element and the socket on the other side, preferably the sterile side.

[0018] More preferably (alternatively or cumulatively), a second housing is disposed on the other side of the sterile separation element, the second housing being configured to press against the first housing through the sterile separation element (as a sterile intermediate layer), wherein the at least one contact pin thereby penetrates the sterile separation element and protrudes into the interior of the second housing. The second housing may preferably be configured as a receiving tube, such that an additional socket or plug can be inserted into the second housing and contact the at least one contact pin; and more preferably, the second housing is held on the contact pin and thus held on the first housing.

[0019] This design is particularly simple, inexpensive, and yet still reliable, making it especially suitable for disposable sterile waterproof tarpaulins.

[0020] In other words, according to this disclosure, a flat, preferably flexible, sterile element for aseptic separation is provided. This sterile separation element is disposed or configured between or adapted between the first and second mating connectors / housings of the mating connection / electromechanical gate; and is therefore disposed or configured to provide or achieve aseptic separation of the mating connectors.

[0021] The plug connection is preferably a force-fit and / or form-fit connection. When the first and second plug connectors / housings are connected, preferably, a sterile separation element is positioned between the plug connectors such that the sterile separation element almost automatically adapts to the geometry of the plug connection between the plug connectors.

[0022] The concept of aseptic separation can be understood here in particular as the separation of sterile elements from non-sterile elements in such a way that the sterile elements are not contaminated at least at the contact points or at the locations where manual operation / contact is performed.

[0023] Advantageous implementation methods are described in more detail below.

[0024] For example, aseptic separation elements can be foldable and / or flexible. Aseptic separation elements can also be designed for single use, such as as disposable items. This allows for the provision of reliable and hygienic aseptic separation devices in a simple manner and method.

[0025] The plug connector can be an electrical plug connector. One plug connector of the plug connector can be male (contact pin), while the other plug connector of the plug connector can be female (receptacle).

[0026] A sterile separation element is provided for passage of a number (or more) of electrical contacts of a male connector (contact pin). Specifically, the sterile separation element can be provided to form an intermediate layer between the female connector / receptacle and the male connector (contact pin) during their mating process.

[0027] In advantageous designs (alternatively or cumulatively), the aseptic separation element can be sized such that the flat element, when in use, forms a clamp on one of the connectors. This allows for easy gripping of the connector without the risk of contamination.

[0028] The sterile separation element can, for example, be impregnated with a disinfectant. The disinfectant can be prepared based on an alcohol (ethanol or 2-propanol) and methyl ethyl ammonium sulfate. Additionally, the disinfectant can contain a refining substance that prevents skin irritation. Therefore, the flat element can be a hand sanitizing cloth. The disinfectant may also contain one or more of the following agents: oxidants, peracetic acid, hydrogen peroxide, halogens (iodine and chlorine compounds), ozone, phenol derivatives (including chlorobenzylphenol, triclosan), aldehydes (e.g., formaldehyde), alcohols, detergents, nitrogen-containing compounds (e.g., benzalkonium chloride), etc. (chlorhexidine, oxytetracycline, polyhexylguanidine). Therefore, the flat element itself can be sterile / non-sterile.

[0029] Similarly, the aseptic separation element is preferably (alternatively or cumulatively) designed to form a sleeve on the cable connected to the connector during use. This allows personnel to easily operate / connect the connector without contaminating themselves.

[0030] According to one or more embodiments, the aseptic separation element can be a membrane, cloth, or waterproof tarpaulin. The aseptic separation element can be configured to be tear-resistant. The flat element can withstand at least a predetermined tensile force, for example, at least 1 N / mm². 2 or 10N / mm 2 In other words, tensile strength. Similarly, flat elements can be designed to withstand maximum tensile force, such as 15 N / mm². 2 Or 150N / mm 2 .

[0031] Non-sterile connectors may (optionally or cumulatively) have a fastener for mounting to an externally fixed object, such as on an operating table. This allows personnel to simply grasp the sterile component to connect sterile and non-sterile cables, for example, by means of a connector adapter or a flat element. Attached Figure Description

[0032] The present disclosure will now be explained in more detail with reference to the accompanying drawings and preferred embodiments. It is shown that:

[0033] Figure 1 A schematic diagram of a sterile barrier in the form of a sterile separation element with an electromechanical gate, shown in a general illustration or in a general basic structure, is provided to illustrate the main components / parts of the device according to this disclosure.

[0034] Figure 2 A schematic diagram of a sterile barrier in the form of an electromechanical gate with a sterile separation element according to a first preferred embodiment of the present disclosure is shown (involving at least one electrical contact pin having two free pin ends), the sterile separation element being particularly configured as a sterile separation module;

[0035] Figure 3A schematic diagram of a sterile barrier in the form of an electromechanical gate-based sterile separation element according to a second preferred embodiment of the present disclosure is shown (involving at least one electrical contact pin having two free pin ends), the sterile separation element being particularly configured as a sterile separation module, and...

[0036] Figure 4 This shows the general layout / subdivision of sterile and non-sterile areas.

[0037] Wherein: 1-Sterile separation element / sterile cloth / cover cloth; 2-Electromechanical gate / sterile separation module; 3-Fixed wire connection part / contact; 4-Electronic device; 5-Cable bundle / wire bus; 6-Retaining element; 8, 13-Plug; 9-Contact pin / gate contact; 10-First housing / plug connector; 11-Second housing / plug connector; 12-Socket. Detailed Implementation

[0038] Figure 1 A sterile barrier is shown in general representation or in a general basic structure to illustrate the main components / parts of an arrangement according to this disclosure, wherein the arrangement has:

[0039] - A flexible, preferably cloth-like or waterproof tarpaulin-like, sterile separation element 1 (hereinafter referred to as sterile cloth);

[0040] - An electromechanical gate 2 in / on the sterile cloth 1 has at least one electrical contact pin 9, which passes through the sterile separation element 1 in a spaced manner; and

[0041] - (First) Line bus 5, consisting of a certain number / multiple wires / cables, which are guided to gate 2 in a non-sterile area, and another (second) line bus 5, consisting of a corresponding number / multiple wires / cables, which are guided away from gate 2 in a sterile area.

[0042] Specifically, sterile drape 1 is an antimicrobial fabric or (antimicrobial) film that is configured and constructed to separate sterile areas from non-sterile areas. For example, a sterile area may be a surgical area / space in which a robotic arm or various actuators and / or controllers / medical devices reside, which are themselves non-sterile areas and therefore must be antimicrobially isolated from the sterile area. For this purpose, such non-sterile areas can be surrounded / covered by the sterile drape 1 shown, wherein, however, it must be ensured that, for example, electrical equipment, power sources, or control units pass through the sterile drape 1 within the non-sterile area and make electrical contact with (medical or surgical) devices in the sterile area, such as surgical handpieces, lighting devices, etc., without damaging / disrupting the antimicrobial sterile barrier.

[0043] This basic structure or general foundation structure corresponds to, according to Figure 4 The arrangement makes it possible to refer to the above references regarding this point. Figure 1 Description. To maintain sterility, an electromechanical gate 2 is provided according to this disclosure, as will be described in more detail below.

[0044] In principle, the electromechanical gate 2 according to this disclosure has a certain number, preferably multiple, of contact pins (gate contacts) 9, which are preferably stored / fixed in the first housing (sleeve) 10 such that the contact pins protrude from the first housing 10 in a spindle shape on the housing side (hereinafter referred to as the abutment side). Here, the contact pins 9 are arranged with parallel spacing between each other.

[0045] Each contact pin 9 has at least one free / free-protruding pin end or free end section, which is provided and constructed / adapted for penetrating the sterile cloth 1. For this purpose, the pin end of the corresponding contact pin 9 may, for example, be sharpened or ground, or the corresponding contact pin 9 may have such a small diameter that the contact pin can be pierced by the sterile cloth 1 without breaking the sterile cloth 1. Crucially, a very narrow insertion hole is formed, so that the pierced contact pin 9 is subsequently completely and sterilely surrounded by the sterile cloth 1.

[0046] Preferably, the control electronics, such as the batteries for controlling electromedical / surgical devices or similar working devices located in a sterile area, are already housed within the first housing 10. In this case, each electromedical / surgical device is provided with a device-specific gate 2 within the sterile area, for example, having device-specific control elements or power supply units already housed within the first gate housing 10.

[0047] According to Figure 1 According to another aspect of this disclosure, at least one electrical contact pin 9 has a free pin end that is configured to make electromechanical or conductive plug-in contact with a corresponding electrical socket 12 of at least one wire 5 on the sterile or non-sterile side of the sterile separation element 1, while at another pin end, at least another wire 5 is fixedly connected to a corresponding other side of the sterile separation element 1. Here, a wire (cable) is fixed to another free pin end or another free end segment of each contact pin 9, the wires being combined into a wire bus (cable bundle) 5, which is guided outward through a housing opening on the housing side away from the contact side. This cable bundle 5 is then electrically coupled (not further shown) to a corresponding medical device within the sterile area.

[0048] Finally, usually (as per...) Figure 1As shown, a retainer 6 may be arranged / constructed on the first housing 10, which can be used to fix the first housing 10 to a fixed object, such as an operating table, so as to keep the gate 2 and the sterile cloth 1 in a fixed position.

[0049] A second housing 11 is shown on the side of the sterile cloth 1 facing away from the first housing 10. The second housing has a generally hollow cylindrical / tubular shape, wherein the end sides of the second housing abut against the sterile cloth, and wherein the sterile cloth 1 is sandwiched between the first housing 10 and the second housing 11. The free pin ends / end sections of the contact pins 9 (which have been squeezed through the sterile cloth 1) extend into the internal space of the hollow cylindrical second housing 11.

[0050] These free pin ends of the contact pins 9 are provided and configured for electrical insertion into contact sockets 12, on which wires / cables are also securely held, the wires / cables being bundled into a cable bundle 5 comparable to the cable bundle 5 on the other sterile fabric side. Once these sockets 12 are inserted into the free pin ends / end sections of the contact pins 9, these sockets press the sterile fabric 1 against the abutting side of the first housing 10 on the other sterile fabric side and thereby hold the entire gate structure together.

[0051] It should be pointed out here that, Figure 1 The contact socket 12 shown separately can also be combined into a plug whose shape is adapted to the hollow cylindrical second housing 12 so that it can be inserted into the second housing.

[0052] Figure 2 A first embodiment of this disclosure is shown, wherein, as discussed below, for example according to Figure 1 The different structural features (all other foregoing descriptions therefore also apply to the first embodiment according to this disclosure); the same concepts and reference numerals are used here for the same components.

[0053] In this case, according to Figure 1 Unlike the first housing 10, the first housing 10 (which is identical to the second housing 11) also forms an insertion cylinder for a certain number of sockets or plugs 13, the sockets being assembled into the plugs and the plugs being adapted to the insertion cylinder of the first housing 10. That is, according to Figure 2 According to the first embodiment (or variation) of this disclosure, the fixed wire connection portion 3 (as it is in) Figure 1 As shown in the figure, the contact pin 9 is replaced by an additional plug connection, such that the contact pin 9 has two free pin ends / end sections which are provided and constructed for plug connection with the corresponding wires / cables.

[0054] Furthermore, according to Figure 2 According to the first embodiment of this disclosure, the retainer 6 for fixing the gate 2 to an object in a fixed position is not arranged / constructed on the first housing 10, but is arranged / constructed on the plug 13. Furthermore, according to... Figure 2 According to the first embodiment of this disclosure, plug 8 is now also illustrated, as it was previously shown in Figure 1 As mentioned in the alternatives / alternatives to socket 12 shown in the diagram.

[0055] This disclosure generally relates to a sterile separation element 1 for sterile separation, the sterile separation element being arranged between plug connectors 10, 11 of the plug connection / electromechanical gate and thus providing sterile separation of the plug connectors 10, 11.

[0056] exist Figure 3 The second embodiment of the present disclosure is illustrated at least schematically, and the differences from the first embodiment are described in more detail below.

[0057] As in Figure 2 As can be seen, the contact pin 9 is constructed as a uniform rod forming an insertion end on both sides of the aseptic separation element 1, the insertion end being able to be inserted into a socket in a plug-like manner. This means that sockets must be provided on both sides of the aseptic separation element 1, the sockets being able to make contact with the plugs constructed on both sides of the electrical / electromechanical switch 2.

[0058] However, it has been shown that medical electrical devices are already equipped with cables, which typically have plugs with simple contact pins already installed on them. In order to connect the plug to... Figure 2 An additional adapter must be provided on the gate 2. To avoid this additional component, in the second embodiment of this disclosure, at least one contact pin 9 is designed as a sleeve / socket shape on the end side, at least on the sterile side of the sterile separation element 1, such that the gate 2 on the sterile side of the sterile separation element 1 forms a type of socket, into which a plug having at least one single simple contact pin can be inserted, for example in... Figure 1 As shown in the figure. This variant is relative to the one based on Figure 2 The advantage of the variant shown is that the plug already present in the medical device can be directly placed in the insertion contact with the gate 2.

[0059] According to other aspects of this disclosure, especially with reference to the appendix Figure 1The schematic diagram (particularly relating to the features of at least one electrical contact pin having a free pin end and another pin end fixedly connected to the associated wire) is not the subject of this application, but may be further pursued in subsequent divisional applications. This objective is (alternatively) achieved by the following features or combinations thereof:

[0060] 1. According to an embodiment of this additional aspect: a sterile barrier having a flat sterile separation element 1, preferably in the form of a cover or detachable waterproof tarpaulin, and the sterile barrier having an integrated or insertable electromechanical gate 2 in the sterile separation element 1, the electromechanical gate being used to electrically connect at least one electrical wire 5 on one non-sterile side of the sterile separation element 1 to at least one electrical wire 5 on the other sterile side of the sterile separation element 1, wherein the electromechanical gate 2 has at least one electrical contact pin 9 that passes through the sterile separation element 1 individually, such that the sterile separation element 1 directly and sterilely abuts against the at least one electrical contact pin 9; characterized in that the at least one electrical contact pin 9 has a freely protruding pin end, the pin end being provided and configured to enter into an electromechanical or conductive plug-in contact with a corresponding electrical socket and / or pin 12 of the at least one wire 5 on the sterile or non-sterile side of the sterile separation element 1, while at least another wire 5 is fixedly connected to the corresponding other side of the sterile separation element 1 at the other pin end.

[0061] 2. An embodiment according to another aspect: The sterile barrier of the first embodiment according to the other aspect is characterized in that the sterile separation element 1 is in the form of a film, cloth, and / or plate.

[0062] 3. An embodiment according to another aspect: The sterile barrier according to any one of the first or second embodiments of the other aspect described above is characterized in that the electromechanical gate 2 forms an electromechanical coupling module, the electromechanical coupling module including at least one first module housing 10, the first module housing having a sterile separation element contact side or contact surface, and a free pin end of the at least one electrical contact pin 9 freely protruding from the sterile separation element contact side or contact surface.

[0063] 4. An embodiment according to another aspect: The sterile barrier of the third embodiment according to the other aspect is characterized in that the first housing is closed on the housing side away from the abutment side, and has a through opening for the at least one wire 5 on the sterile or non-sterile side of the sterile separation element 1, the wire being fixedly connected to the at least one contact pin 9.

[0064] 5. An embodiment according to another aspect: The sterile barrier according to any one of the third to fourth embodiments of the other aspect is characterized in that the electromechanical coupling module has a second module housing 11 in the form of a hollow cylinder, the second module housing surrounding an axially continuous insertion cylinder and the second module housing is configured to abut against the sterile separation element 1 on an end side such that the free end of the at least one contact pin 9 that has passed through the sterile separation element 1 extends into the insertion cylinder of the second module housing 11, wherein a socket 12 for inserting the at least one other wire 5 is available on the other end side.

[0065] 6. An embodiment according to another aspect: The sterile barrier according to any one of the first to fifth embodiments of the other aspect is characterized in that it is provided with a plurality of contact pins 9, the contact pins being parallel and spaced apart, wherein a corresponding number of contact sockets 12 are provided on at least one side of the sterile separation element 1, the contact sockets being combined to form a unique plug 8, 13.

[0066] 7. An embodiment according to another aspect: The sterile barrier of the sixth embodiment according to the other aspect is characterized in that the first module housing 10 or the plug 13 is configured with or may be equipped with the retainer 6, the retainer being provided and configured for fixation to an external object, particularly an operating table.

Claims

1. A sterile barrier having a flat sterile separation element (1) and an electromechanical gate (2) capable of being inserted into / connected to the sterile separation element (1), the electromechanical gate being used to electrically connect at least one electrical wire (5) on a non-sterile side of the sterile separation element (1) to at least one electrical wire (5) on the other sterile side of the sterile separation element (1), the electromechanical gate (2) having at least one electrical contact pin (9), wherein The at least one electrical contact pin (9) has two freely protruding pin ends, which are configured and constructed to engage with the corresponding electrical pins and / or sockets (12) of the at least two wires (5) to be connected in electromechanical or conductive plug contacts. Its features are, The electromechanical gate (2) is not integrated and can be inserted into / connected to the aseptic separation element (1) through which at least one electrical contact pin (9) of the electromechanical gate (2) is to be passed individually at the contact position. This allows the sterile separation element (1) to be directly and completely attached to the at least one electrical contact pin (9) in an antibacterial manner.

2. The sterile barrier according to claim 1, characterized in that, The sterile separation element (1) is in the form of a film, cloth, and / or plate.

3. The sterile barrier according to claim 1 or 2, characterized in that, The electromechanical gate (2) forms an electromechanical coupling module, which includes at least one first module housing (10) having a sterile separation element contact side or contact surface, and a free pin end of the at least one electrical contact pin (9) protruding freely from the sterile separation element contact side or contact surface.

4. The sterile barrier according to claim 3, characterized in that, The first module housing forms an insertion tube on the housing side away from the abutment side, and the other free pin end of the at least one electrical contact pin (9) extends into the insertion tube and the at least one socket (12) can be inserted into the insertion tube.

5. The sterile barrier according to claim 3, characterized in that, The electromechanical coupling module has a second module housing (11) in the form of a hollow cylinder, the second module housing surrounding an axially continuous insertion cylinder and the second module housing being configured to abut against the sterile separation element (1) on an end side such that the free end of at least one contact pin (9) that has passed through the sterile separation element (1) extends into the insertion cylinder of the second module housing (11), wherein a socket (12) for inserting the at least one other wire (5) is available on the other end side.

6. The sterile barrier according to claim 1, characterized in that, The pin end or pin end section forms a male plug on one side, the male plug being constructed and designed to connect to the female socket of the cable.

7. The sterile barrier according to claim 1, characterized in that, The pin end or pin end section is configured with a female socket on one side of the side, the female socket being configured for connection with a male plug of a cable.

8. The sterile barrier according to claim 6 or 7, characterized in that, The male plug and the female socket are constructed in a complementary manner.

9. The sterile barrier according to claim 1, characterized in that, A plurality of contact pins (9) are provided, the contact pins being parallel and spaced apart, wherein a corresponding number of contact sockets (12) are provided on at least one side of the sterile separation element (1), the contact sockets being combined to form a unique plug (8, 13).

10. The sterile barrier according to claim 9, characterized in that, The plug (13) is configured with or may be equipped with a retainer (6), which is provided and configured for attachment to an external object.

11. The sterile barrier according to claim 3, characterized in that, The first module housing (10) is configured with or may be equipped with a retainer (6), the retainer being provided and configured for fixing to an external object.

12. A system comprising a medical device, an energy source for the medical device, and a sterile barrier according to any one of claims 1 to 11, wherein, The sterile barrier has a gate (2) which is arranged between the medical device and the energy source in the form of an intermediate extension.

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