Electromechanical sterilization and separation
The sterile separating element with an electromechanical lock provides a reliable and hygienic solution for connecting sterile and non-sterile surgical components, ensuring sterility and ease of use by using connecting pins that penetrate the element to establish germ-proof connections.
Patent Information
- Application Number
- JP2025146918
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2020-06-25
- Filing Date
- 2025-09-04
- Publication Date
- 2025-12-23
AI Technical Summary
Existing sterile barriers in surgical environments fail to provide reliable, hygienic, and cost-effective solutions for repeatedly connecting and disconnecting sterile and non-sterile surgical components, particularly electromechanical interfaces, which leads to contamination and limited reusability of surgical instruments.
A sterile separating element, such as a sheet or foil, integrated with an electromechanical lock featuring connecting pins that penetrate the element to establish germ-proof connections between sterile and non-sterile areas, allowing for easy and hygienic coupling of electrical devices without additional adapters.
The solution ensures reliable, hygienic, and cost-effective isolation between sterile and non-sterile areas by providing a sterile barrier ensures that the sterile elements are not contaminated, maintaining sterility at predetermined points of contact, and allowing for easy manipulation of plug connectors without risk of contamination.
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Figure 2025186310000001_ABST
Abstract
Description
[Technical Field]
[0001] The present disclosure relates to a sterile barrier having a covering or separating element, for example a sheet or foil (also called a drape), and an electromechanical antimicrobial lock integrated into or integrable / attachable to said element, for transmitting electrical energy and / or electrical control signals from wiring on the non-sterile side to wiring on the sterile side, and in particular to a sterile barrier according to the preamble of claim 1. [Background technology]
[0002] As digitalization in the operating room increases, the electronics and software of electrically driven surgical motor systems are increasingly integrated. Because electronic elements can only be sterilized with considerable effort and limitations, the fundamental objective is to provide or separate surgical drives, for example, in sterile areas (instruments that can be reprocessed without restrictions and operated without restrictions by the surgeon) and non-sterile areas (instruments that are critical for reprocessing and must not be touched by the surgeon). One advantage of this concept is that essential parts of the surgical drive are transferred to the non-sterile area, minimizing the amount of mass the surgeon has to handle. These two areas (sterile area / non-sterile area) must, on the one hand, be electromechanically connected before surgery, and, on the other hand, alternately disconnected and reconnected with the other sterile area during surgery. Ideally, this work is performed by a sterile technician at the operating table in accordance with sterilization requirements. This requires a sterile separation concept that is compatible with current surgical hygiene requirements and can be reliably implemented.
[0003] Attached Figure 3 shows a typical arrangement of sterile and non-sterile areas separated by a sterile barrier that may be provided for the present disclosure.
[0004] For example, a robot 100 including an actuator or holding device is placed in a non-sterile area U shielded from a surrounding sterile area S by a drape 101. The drape has at least two passages / openings 102, 103, one of which, passage 102, is configured as an access opening for the holding arm of the robot 100, and the other passage 103, is configured to connect a sterile cable section 104 in the sterile area S to a non-sterile cable section (not shown) in the non-sterile area U. For this purpose, a connector device 105 is provided. In this case, the cable in the sterile area S is connected to, for example, a control unit 106 for controlling the robot 100.
[0005] Another basic application example is, for example, the contact of a drive motor in a sterile area with a control module or robot arm in a non-sterile area. For example, it is already known to attach a so-called protective shield to a sterile motor cable. The protective shield is arranged in such a way that the risk of contact with non-sterile components is reduced during the connection / plugging process or when plugging the motor cable into a non-sterile control unit. This so-called protective shield is also called a sterile protective cap.
[0006] However, a significant drawback is that after a single connection / plug-in, the motor cable becomes contaminated, at least in its connector area, making it impossible to remove / unplug the cable and return it to the sterile instrument table in the sterile area, which prevents different drives from being used for different surgical steps during surgery.
[0007] Furthermore, in the state of the art there exist so-called sterile barriers in the form of cover or separating sheets which separate sterile and non-sterile areas and which are provided with interfaces or ports through which supply lines can pass, for example such interfaces having a number of flaps which can be opened or closed to form corresponding passages as required.
[0008] U.S. Patent Application Publication No. 2018 / 0145443 discloses an electrical connector associated with an electromagnetic tracking device that can be moved and tracked within a patient's body. In a multi-part electrical (plug) connector system for use in a medical environment, a first section of the connector system is positioned to pierce a moldable sterility barrier, e.g., made of a textile material, during coupling of the first section of the connector system to a second section of the connector system. However, as can be seen particularly in Figures 9, 11A, and 11E of U.S. Patent Application Publication No. 2018 / 0145443, the proposed perforations have the disadvantage of not limiting (locally) the microbial pathway at each spot. As a result of the lack of restriction of contamination at the perforated holes, any previously existing sterility is naturally compromised or terminated.
[0009] U.S. Patent Application Publication No. 2018 / 0049833 discloses a sterile barrier for use with a surgical robotic system. The sterile barrier may include a housing configured to connect with a tool driver connected to a robotic arm and removably receive a surgical tool. The sterile barrier housing has a sterile flexible fabric extending therefrom, the housing and the flexible fabric being formed in two or more planes and defining a sterile side on which the surgical tool is placed and a non-sterile side on which the tool is placed. The housing may have at least one pin-shaped electrical connection configured to operably connect with at least one complementary electrical connection provided on at least one of the tool driver and the robotic arm. Thus, the fabric is formed with prefabricated openings positioned or configured to respectively receive the pin-shaped electrical connection.
[0010] U.S. Patent Application Publication No. 2016 / 0058513 discloses another sterility barrier known in the prior art, in which a surgical system includes a first element having a seat for removably receiving a surgical instrument for surgical use, and two connectors, at least one of which is provided with an electrical connection for engaging the other connector, adapted to be controllably movable between a first retracted stop position and a second advanced position for electrical connection with the other connector.
[0011] Furthermore, the applicant's German utility model no. 202007002332 discloses a medical sterile cover, through which openings are provided in the cover, plug connections are inserted into corresponding plug sockets, for which a strong adhesive seal is proposed. Summary of the Invention [Problem to be solved by the invention]
[0012] It is therefore an object of the present disclosure to avoid or at least mitigate the drawbacks of the prior art, in particular that interfaces present on the operating table for repeated application / separation of sterile applied and non-sterile surgical components, such as electromechanical interfaces, should be reliable, hygienic, and / or cost-effective. [Means for solving the problem]
[0013] According to the present disclosure, this problem is solved by a sterility barrier having the features of claim 1. Further advantageous developments of the present disclosure are the subject matter of the subclaims.
[0014] The core idea of the present disclosure is essentially to provide a simple sterile separating element (sterile barrier), for example in the form of a sheet, foil or drape, and an electromechanical lock / coupling with at least one connecting pin arranged and configured to be insertable / pluggable / pluggable into the sterile separating element from one side like a mandrel and to protrude from the other side of the sterile separating element, so that the at least one connecting pin is germicidally surrounded (closely / directly) by the sterile separating element or the sterile separating element fits germicidally around the at least one connecting pin, which can be connected at at least one end / end section by a line, for example by means of a plug socket or a plug.
[0015] It should be noted at this point that at least one connecting pin may have two essentially similar / identical rod / pin ends, so that two similar / identical sockets with or consisting of corresponding socket-shaped / sleeve-shaped connecting elements can be inserted on both sides. However, it is also conceivable that at least one connecting pin is formed with (two) different pin ends, in particular so that one end, preferably on the non-sterile side of the sterile separating element, is formed as a (small-diameter) pin and the other end, preferably on the sterile side of the sterile separating element, is formed as a (large-diameter) sleeve / plug socket. In this way, a connecting pin that penetrates a sterile separating element may be inserted on one side (non-sterile side) into a type of socket / plug socket with a (large-diameter) sleeve-shaped connecting pin and on the other side (sterile side) into a type of plug / insertion pin with a (small-diameter) pin shape. The latter offers the advantage that, for example, electrical medical devices on the sterile side, to which electrical cables (with pin-shaped electrical connections) and cable plugs are normally fastened, can be electrically coupled to at least one connecting pin (or its sleeve-shaped pin end) without an additional (intermediate) adapter. The same applies to so-called extension cables on the non-sterile side: the socket at one end of each extension cable with at least one sleeve-shaped connecting pin can also be electrically coupled, without an adapter, to the pin-shaped pin end of at least one connecting pin inserted into the sterile separation element.
[0016] Preferably (alternatively or cumulatively), at least one connecting pin is held in / by a first housing on one side of the sterile separating element, the first housing forming a receiving shaft for the plug socket and / or the plug, or at least one line fixed to at least one connecting pin leads out from the first housing. It should also be noted here that it is not necessarily necessary for the same type of receiving shaft or plug socket to be arranged on both sides of the sterile separating element, but preferably the plug may be arranged on one side, which is the non-sterile side, of the sterile separating element, and the plug socket on the other side, which is preferably the sterile side.
[0017] Further preferably (alternatively or cumulatively), a second housing is provided on the other side of the sterile separating element, the second housing being configured to be pressed against the first housing via the sterile separating element (as a sterile intermediate layer), so that the at least one connecting pin protrudes through the sterile separating element into the interior of the second housing. Thus, the second housing may preferably be formed as a receiving shaft and further preferably holds the second housing at the connecting pin, i.e., at the first housing, so that a further plug socket or plug can be inserted into the second housing and connected with the at least one connecting pin.
[0018] Such a design is particularly suitable for one-way sterilization sheets, as it is simple, inexpensive and reliable.
[0019] In other words, according to the present disclosure there is provided a flat, preferably flexible, sterile element for sterile isolation, the sterile isolation element being adapted or configured to be disposed between or fit between a first plug connector / housing and a second plug connector / housing of a plug connection / electromechanical lock, and thus to provide or achieve sterile isolation of the plug connectors.
[0020] The plug connection may preferably be a force-lock and / or form-fit connection. When connecting the first plug connector / housing and the second plug connector / housing, the sterile separation element may preferably be disposed between the plug connectors and substantially solely conforms to the geometry of the plug connection between the plug connectors.
[0021] In this specification, the term "sterile separation" should be interpreted to mean, in particular, separating sterile elements from non-sterile elements so that the sterile elements are not contaminated, at least at predetermined points of contact or points intended for manual manipulation / contact.
[0022] Advantageous embodiments are claimed in the subclaims and are explained in more detail below.
[0023] For example, the sterile separating element may be foldable and / or flexible. The sterile separating element may be provided for single use, for example as a disposable item. In this way, a reliable and hygienic sterile separating means can be easily provided.
[0024] The plug connection may be an electrical plug connection, one of the plug connectors of the plug connection may be male (connection pins) and the other of the plug connectors of the plug connection may be female (plug socket).
[0025] The sterile separating element is provided to be penetrated by some (or several) electrical connections of the male plug connector (connection pins). In particular, the sterile separating element may be provided to form an intermediate layer between the female plug connector / plug socket and the male plug connector (connection pins) during the plugging process thereof.
[0026] In an advantageous embodiment (alternatively or cumulatively), the sterile separating element may be dimensioned such that, in use, the flat element forms a fold over one of the plug connectors, which allows the plug connector to be easily gripped without risk of contamination.
[0027] For example, (alternatively or cumulatively) the sterilized separating element may be impregnated with a disinfectant. For example, the disinfectant may be based on alcohol (ethanol or 2-propanol) and mecetronium ethyl sulfate. Furthermore, the disinfectant may contain lipid substances to avoid skin irritation. Thus, the flat element may be a hand disinfecting wipe. The disinfectant may also contain one or more of the following: oxidizing agents, peracetic acid, hydrogen peroxide, halogens (iodine, chlorine compounds), ozone, phenol derivatives (including chloroxylenol, triclosan), aldehydes (e.g., formaldehyde), alcohol, detergents, nitrogen compounds (e.g., benzalkonium chloride), and the like (chlorhexidine, octenidine, polyhexanide). Thus, the flat element itself may be sterile / aseptic.
[0028] Likewise, preferably (alternatively or cumulatively), the sterile separation element may be configured to, in use, form a fold back onto the cable connected to the plug connector, allowing an operator to easily manipulate / connect the plug connector without contaminating it.
[0029] According to any or multiple embodiments, the sterile separating element may be a foil, a drape, or a sheet. The sterile separating element may be configured to be puncture resistant. At least the flat element may have a puncture resistance of at least 1 N / mm. 2 or 10N / mm 2 The flat element may also be able to maintain a predetermined tensile force, i.e. be able to withstand a tensile force, such as 15 N / mm 2 or 150N / mm 2 The tension may be configured for a maximum tension force of 100 MPa, 150 psi, 100 psi ...
[0030] In particular, the non-sterile plug connector may (alternatively or additionally) comprise a mounting portion for attachment to an external stationary object, such as an operating table, so that the operator only needs to touch the sterile part to connect the sterile cable to the non-sterile cable, for example by means of a plug connection adapter or flat element.
[0031] The present disclosure will be described in more detail below based on preferred embodiments with reference to the accompanying drawings, in which: [Brief explanation of the drawings]
[0032] [Figure 1] 1 shows a schematic diagram of a sterility barrier in the form of a sterile separation element with an electromechanical lock in a schematic view or basic structure to show the essential parts / components of the arrangement according to the present disclosure. [Figure 2] 1 shows a schematic diagram of a sterile barrier in the form of a sterile separation element with an electromechanical lock according to a first preferred embodiment of the present disclosure (concerning at least one electrical connection pin with two free pin ends), in particular configured as a sterile separation module. [Figure 3] 1 shows a schematic diagram of a sterile barrier in the form of a sterile separation element with an electromechanical lock according to a second preferred embodiment of the present disclosure (relating to at least one electrical connection pin with two free pin ends), in particular configured as a sterile separation module. [Figure 4] Shows the general layout / division of sterile and non-sterile areas. DETAILED DESCRIPTION OF THE INVENTION
[0033] FIG. 1 shows a sterile barrier in a schematic diagram or general basic structure to show the essential parts / components of a configuration according to the present disclosure, comprising a flexible, preferably drape- or sheet-like, sterile separation element 1 (hereinafter simply referred to as a sterile drape), an electromechanical lock 2 located within / on the sterile drape 1, the electromechanical lock 2 having at least one electrical connection pin 9 that individually penetrates the sterile separation element 1, a (first) line bus 5 consisting of several / multiple lines / cables leading to the lock 2 in the non-sterile area, and a further (second) line bus 5 consisting of a corresponding several / multiple lines / cables extending away from the lock 2 in the sterile area.
[0034] Specifically, the sterile drape 1 is a germ-resistant cloth or foil that is provided and configured to separate a sterile area from a non-sterile area. For example, the sterile area may be an operating room / operating room where a robotic arm or various drive and / or control devices / medical devices are placed; these devices constitute a non-sterile area in themselves and must therefore be germ-resistantly separated from the sterile area. For this purpose, such a non-sterile area may be surrounded / covered by the illustrated sterile drape 1, but it must be ensured that, for example, electrical devices, energy sources, or control systems in the non-sterile area can be electrically connected through the sterile drape 1 to (medical-technical or surgical) devices in the sterile area, such as electrical surgical drive handles, lighting means, etc., without damaging / destroying the germ-resistant sterile barrier.
[0035] This basic or schematic basic structure corresponds to the configuration shown in Figure 4, and therefore reference can be made in that regard to the above description with reference to Figure 1. For the maintenance of sterility, an electromechanical lock 2 according to the present disclosure is provided, which will be described in more detail below.
[0036] In principle, the electromechanical lock 2 according to the present disclosure has several, preferably a plurality of, contact pins (lock contacts) 9, which are preferably supported / fixed in a first housing (sleeve) 10 and protrude in the form of mandrels from the first housing 10 on one side of the housing (hereinafter referred to as the abutment side). The contact pins 9 are arranged parallel to one another at intervals.
[0037] Each connecting pin 9 has at least one free pin end / freely protruding pin end or free end section that is provided and configured / adapted to penetrate the sterile drape 1. To this end, one pin end of the connecting pins 9 may be, for example, pointed or sharp, or each connecting pin 9 has a diameter small enough to penetrate the sterile drape 1 without tearing it. Importantly, such a small perforation is formed so that the sterile drape 1 fits germ-proof around the entire circumference of the pin, surrounding the penetrated connecting pin 9.
[0038] Preferably, the control electronics, such as e.g. electronics 4 for controlling the batteries of electromedical / surgical devices or similar work equipment placed in the sterile area, may already be arranged in the first housing 10. In this case, each electromedical / surgical device in the sterile area is assigned a device-specific lock 2, e.g. with device-specific control elements or power sources etc. already present in the first lock housing 10.
[0039] According to a further partial disclosed embodiment shown in Fig. 1, at least one electrical connection pin 9 has a free pin end configured to make an electromechanical or electrically conductive plug connection with a corresponding electrical plug socket 12 of at least one line 5 on the sterile or non-sterile side of the sterile separation element 1, while at least another line 5 is securely connected at its other pin end on the other side of the sterile separation element 1. Thus, lines (cables) are fixed to the other free pin end or other free end section of each connection pin 9, and these lines (cables) combine to form a line bus (cable harness) 5, which is led to the outside through a housing opening provided on the side of the housing opposite the abutment side. This cable harness 5 is then electrically connected to a corresponding medical device (further not shown) in the sterile area.
[0040] Then, generally (as shown in FIG. 1), a holder 6 may be arranged / configured on the first housing 10, and the holder 6 may secure the first housing 10 to a (stationary) fixed object such as an operating table, for example, to steadily hold not only the lock 2 but also the sterile drape 1.
[0041] On the side of the sterile drape 1 opposite the first housing 10 is shown a second housing 11 having a hollow, generally cylindrical / tubular shape, one end face of the second housing 11 abutting the sterile drape 1, with the sterile drape 1 being sandwiched between the first housing 10 and the second housing 11. Thus, one free pin end / end section of the connecting pin 9 (which has already been pushed through the sterile drape 1) protrudes into the interior of the hollow cylindrical second housing 11.
[0042] These free pin ends of the connection pins 9 are provided and configured for electrical plug connection with connection sockets 12, which also have lines / cables attached to them which together form a cable harness 5 equivalent to the cable harness 5 on the other side of the sterile drape. When these plug sockets 12 are plugged into the free pin ends / end sections of the connection pins 9, the plug sockets 12 press the sterile drape 1 against the abutting side of the first housing 10 located on the other side of the sterile drape, thereby holding the entire locking assembly in place.
[0043] It should be noted that the connecting sockets 12 shown separately in FIG. 1 may be combined to form a plug shaped to fit into the hollow cylindrical second housing 12 so that it can be inserted.
[0044] 2 illustrates a first embodiment of the present disclosure, and the following primarily discusses design features that differ from the example of FIG. 1 (thus all other above descriptions also apply to the first embodiment according to the present disclosure). In this regard, the same terms and reference numbers are used for the same components.
[0045] In this example, in contrast to the first housing 10 according to Fig. 1 (according to the second housing 11), the first housing 10 also forms an insertion shaft for several plug sockets or plugs 13 combined with plug sockets, the plugs 13 being fitted into the insertion shaft of the first housing 10. That is to say, in the first embodiment (or variant) according to the present disclosure according to Fig. 2, the fixed line connection part 3 shown in Fig. 1 is replaced by an additional plug connection part, and therefore in this example the connection pin 9 has two free pin ends / end sections provided and configured for plug connection with corresponding lines / cables.
[0046] Furthermore, in the first embodiment according to the present disclosure in Fig. 2, the holder 6 for fixing the lock 2 to a (stationary) fixed object is not arranged / configured in the first housing 10, but in the plug 13. Therefore, in the first embodiment according to the present disclosure in Fig. 2, the above-mentioned plug 8 is also shown here diagrammatically as a substitute / alternative for the plug socket 12 shown in Fig. 1.
[0047] In summary, the present disclosure relates to a sterile isolation element 1 for sterile isolation, which is arranged between plug connectors 10, 11 of a plug connection / electromechanical lock and thus is arranged to provide sterile isolation of the plug connectors 10, 11.
[0048] A second embodiment of the present disclosure is shown at least schematically in FIG. 3, and only the differences from the first embodiment will be described in more detail below.
[0049] As can be seen in Figure 2, the connecting pins 9 are configured as uniform rods which form insertion ends on both sides of the sterile separating element 1 and which are insertable like plugs into socket-like insertion sockets. This means that the sterile separating element 1 must be provided on both sides with sockets which are capable of contact-engaging with the plugs of the electric / electromechanical locks 2 configured on both sides.
[0050] However, it is known that medical electrical devices usually already have electrical cables with plugs having simple connecting pins already attached. To connect these to the lock 2 of FIG. 2, an additional adapter must be provided. In order to avoid such additional components, in a second embodiment of the present disclosure, at least on the sterile side of the sterile separation element 1, the end of at least one connecting pin 9 is configured in the form of a sleeve / plug socket, and the lock 2 on the sterile side of the sterile separation element 1 forms a kind of socket into which a plug having at least one simple connecting pin can be inserted, as shown, for example, in FIG. 1. This variant has the advantage over the variant of FIG. 2 that a plug already present in the medical device can be directly plugged into the lock 2.
[0051] According to a partial further aspect of the present disclosure, and in particular with reference to the schematic diagram of FIG. 1 (particularly with regard to the features of at least one electrical connection pin having a free pin end and another pin end firmly connected to a corresponding line), which is not the subject of the present application but may be claimed in a later divisional application, the object is (alternatively) solved by the following features or combinations of features:
[0052] (First embodiment according to further partial aspects) 1. A sterile barrier comprising a flat sterile separating element (1), preferably in the form of a cover sheet or separator sheet, and an electromechanical lock (2) integrated into or insertable / placeable in the sterile separating element (1) for electrically connecting at least one electrical line (5) on one non-sterile side of the sterile separating element (1) to at least one electrical line (5) on the other sterile side of the sterile separating element (1), wherein the electromechanical lock (2) fits directly and germ-proof around at least one electrical connection pin (9) of the sterile separating element (1). 1. A sterile barrier comprising at least one electrical connection pin (9) that individually penetrates the sterile separating element (1) so as to connect at least one line (5) to a corresponding electrical plug socket and / or electrical pin (12) of at least one line (5), the at least one electrical connection pin (9) having a freely protruding pin end that is configured to make an electromechanical or electrically conductive plug connection with a corresponding electrical plug socket and / or electrical pin (12) of at least one line (5) on the sterile or non-sterile side of the sterile separating element (1), and at least another line (5) being securely connected to the other pin end on the other side of the sterile separating element (1).
[0053] (Second embodiment according to further partial aspects) The sterility barrier of the first embodiment according to a further partial aspect, characterized in that the sterile separating element (1) is foil-like, drape-like and / or plate-like.
[0054] (Third embodiment according to further partial aspects) A sterility barrier according to any of the preceding first or second embodiments according to a further partial aspect, characterized in that the electromechanical lock (2) forms an electromechanical coupling module having at least one first module housing (10), the at least one first module housing (10) having a sterile separation element abutment side or abutment surface from which one free pin end of at least one electrical connection pin (9) freely protrudes.
[0055] (Fourth embodiment according to further partial aspects) A sterility barrier according to a third embodiment according to a further partial aspect, characterized in that the first housing is closed on a housing side opposite the abutment side and has a passage opening for at least one line (5) that is firmly connected to at least one connecting pin (9) on the sterile side or the non-sterile side of the sterile separation element (1).
[0056] (Fifth embodiment according to further partial aspects) A sterile barrier according to any of the preceding third to fourth embodiments according to a further partial aspect, characterized in that the electromechanical coupling module has a second module housing (11) in the form of a hollow cylinder, which surrounds an axially continuous insertion shaft and is configured to abut against the sterile separation element (1) at one end face so that the free end of at least one connecting pin (9) already piercing the sterile separation element (1) protrudes into the insertion shaft of the second module housing (11), and at the other end face into which a plug socket (12) of at least one other line (5) can be inserted.
[0057] (Sixth embodiment according to further partial aspects) A sterile barrier according to any of the preceding first to fifth embodiments according to a further partial aspect, characterized in that a plurality of parallel spaced apart connecting pins (9) are provided and a corresponding number of connecting sockets (12) are provided on at least one side of the sterile separation element (1), the connecting sockets (12) combining to form a single plug (8, 13).
[0058] (Seventh embodiment according to further partial aspects) A sterility barrier according to a sixth embodiment according to a further partial aspect, characterized in that the first module housing (10) or plug (13) is configured or can be equipped with a holder (6) configured to be fixed to an external object, in particular an operating table. [Explanation of symbols]
[0059] 1: Sterile isolation element / sterile drape / drape 2: Electromechanical lock / sterilization isolation module 3: Fixed line connections / contacts 4:Electronic equipment 5: Cable harness / line bus 6: Holder 8, 13: Plug 9: Connection pin / lock contact 10: First housing / plug connector 11: Second housing / plug connector 12: Plug socket
Claims
1. a flat sterile separating element (1), preferably flexible, more preferably in the form of a cover sheet or separating sheet; an electromechanical lock (2) integrated into or insertable / placeable on the sterile separation element (1) for electrically connecting at least one electrical line (5) on one non-sterile side of the sterile separation element (1) to at least one electrical line (5) on the other sterile side of the sterile separation element (1), the electromechanical lock (2) having at least one electrical connection pin (9) that individually penetrates the sterile separation element (1) such that the sterile separation element (1) fits directly and germ-proofly around the at least one electrical connection pin (9); 1. A sterility barrier, comprising: at least one electrical connection pin (9) having two protruding free pin ends configured for electromechanical or electrically conductive plug connection with corresponding electrical pins and / or plug sockets (12) of at least two of said lines (5) to be connected.
2. 2. The sterility barrier according to claim 1, characterized in that the sterile separating element (1) is in the form of a foil, a drape and / or a plate.
3. The electromechanical lock (2) forms an electromechanical coupling module having at least one first module housing (10), 3. The sterility barrier according to claim 1, wherein the first module housing (10) has a sterile separating element abutment side or abutment surface from which one free pin end of at least one of the electrical connection pins (9) freely projects.
4. 4. The sterility barrier according to claim 3, characterized in that the first housing has, on a housing side opposite the abutment side, the other free pin end of at least one of the electrical contact pins (9) protruding and forming an insertion shaft into which at least one of the plug sockets (12) can be inserted.
5. The electromechanical coupling module has a second module housing (11) in the form of a hollow cylinder, The second module housing (11) surrounds an axially continuous insertion shaft; 5. The sterility barrier according to claim 3, wherein the free end of at least one connecting pin (9) already passing through the sterile separating element (1) projects into the insertion shaft of the second module housing (11) and is configured to abut against the sterile separating element (1) at one end face, and into which the plug socket (12) of at least one other line (5) can be inserted at the other end face.
6. 6. A sterility barrier according to any one of claims 1 to 5, characterized in that the pin end or pin end section on one side, in particular the non-sterile side, forms a male plug configured and adapted to be connected to a female plug socket of a cable.
7. 7. A sterility barrier according to any one of claims 1 to 6, characterized in that the pin end or pin end section on one side, in particular the sterile side, forms a female plug socket adapted to be connected to a male plug of a cable.
8. 8. A sterility barrier according to claims 6 and 7, characterized in that the male plug and the female plug socket are complementary in shape.
9. A plurality of parallel spaced apart contact pins (9) are provided, 9. A sterile barrier according to any one of claims 1 to 8, characterized in that a corresponding number of connecting sockets (12) are provided on at least one side of the sterile separating element (1), preferably combined to form a single plug (8, 13).
10. 10. The sterility barrier according to claim 9, characterized in that the first module housing (10) or the plug (13) is configured or can be equipped with a holder (6) arranged and configured to be fixed to an external object, in particular an operating table.
11. 12. A system comprising a medical device, an energy source for said medical device, and a sterility barrier according to any one of claims 1 to 11, The system, wherein the sterile barrier comprises a lock (2) arranged in the form of an intermediate plug between the medical device and the energy source in a sterile separating element (1), preferably in the form of a sheet or foil.