ELECTRO-MECHANICAL STERILE SEPARATION

Description

[0001] The disclosure relates to a sterile barrier with a covering or separating element, e.g. a tarpaulin or film (also referred to as a drape) and an electromechanical, germ-tight lock integrated or integrable / mountable therein for the transmission of electrical energy and / or electrical control signals from a non-sterile-side wiring to a sterile-side wiring, and in particular a sterile barrier according to the preamble of claim 1. State of the art

[0002] Increasing digitalization in the operating room leads to the growing integration of electronics and software into electrically driven surgical motor systems. Since electronic components are difficult and not always reprocessable, the general aim is to offer or separate surgical drives into a sterile area (where materials can be reprocessed without restriction and the surgeon can operate them without limitations) and a non-sterile area (where materials requiring reprocessing are located and the surgeon cannot touch them). One advantage of this concept is that the surgeon only has to handle the smallest possible mass (volume), as essential parts of the surgical drives are located in the non-sterile area.These two areas (sterile area / non-sterile area) must be electromechanically connected before the operation and alternately disconnected / separated and reconnected to other sterile areas during the operation. Ideally, this work should be carried out by sterile personnel at the operating table, adhering to strict sterility requirements. This necessitates a sterile separation system that is adapted to current surgical hygiene standards and is easy to operate.

[0003] The adjacent Fig. 3 shows a general arrangement of a sterile and non-sterile area separated by a sterile barrier, and as may also be provided for in the present disclosure.

[0004] For example, a robotic system 100, including actuators or a holding device, is located in a non-sterile area U, which is shielded from the surrounding sterile area S by a drape 101. The drape has at least two airlocks / openings 102, 103, one of which is designed as a passage opening for a holding arm of the robotic system 100, and the other airlock 103 for connecting a sterile cable section 104 in the sterile area S to a non-sterile cable section within the non-sterile area U (not shown). A connector device 105 is provided for this purpose. In this case, the cable in the sterile area S is connected to a controller 106, for example, to control the robotic system 100.

[0005] Other basic application examples include, for example, connecting a drive motor in a sterile area to a control module or a robot arm in a non-sterile area, and the like.

[0006] It is already known, for example, to attach a so-called protective shield to a sterile motor cable. The protective shield is positioned in such a way that it reduces the risk of contact with non-sterile components during a connection / plugging process or when plugging the motor cable into the non-sterile control unit. This protective shield is also called a sterile protective cap.

[0007] A significant disadvantage, however, is that once connected / plugged in, the motor cable is contaminated, at least in the area of ​​its connector, and it is no longer possible to disconnect / unplug the cable and place it back on a sterile instrument table within the sterile area. This prevents different drives from being used for different surgical steps during an operation.

[0008] Furthermore, so-called sterile barriers exist in the prior art in the form of covering or separating sheets, which separate the sterile area from the non-sterile area and are equipped with an interface through which supply lines can be routed. For this purpose, such an interface has a number of flaps that can be opened and closed to create the appropriate passageways as needed.

[0009] US 2018 / 0 145 443 A1 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-in) connector system used in a medical setting, a first section of the connector system is arranged to pierce a malleable sterile barrier, for example, made of a fibrous material, by coupling the first part of the connector system to a second part. However, a disadvantage of this design, as can be seen particularly in Figures 9, 11A, and 11E of US 2018 / 0 145 443 A1, is that the proposed piercing opens the path for germs at the relevant (local) point. As a result of unimpeded contamination through the pierced hole, any previously existing sterility is naturally compromised or lost.

[0010] US 2018 / 0 049 833 A1 discloses a sterile barrier for use with a surgical robotic system. The sterile barrier may include a housing configured to fit a tool driver connected to a robotic arm and to removably receive a surgical instrument. The housing of the sterile barrier has a sterile flexible fabric extending from it, such that the housing and the flexible fabric are formed in more than one plane, defining a sterile side on which the surgical instrument is located and a non-sterile side on which the instrument is located. The housing may have at least one pin-shaped electrical contact configured to fit functionally with at least one complementary electrical contact on at least one of the tool drivers and the robotic arm. The fabric is formed with pre-made openings that are arranged orare designed to guide the electrical pin-shaped contacts through them.

[0011] US 2016 / 0 058 513 A1 discloses another sterile barrier known in the prior art. In this system, a surgical system comprises a first element with a seat that removably receives a surgical instrument for operational use. At least one of two connectors, which is provided with electrical contacts for engaging with the other connector, is designed to be controllably movable between a first retracted rest position and a second advanced position for electrical connection together with the other connector.

[0012] Furthermore, DE 20 2007 002 332 U1 discloses a medical sterile coating, wherein a plug contact is inserted into the respective socket through openings provided in the coating. Permanent adhesive bonding is proposed for sealing purposes.

[0013] WO 2016 / 134266 A1 discloses a sterile barrier arrangement, a fastening system and a method for kinematically coupling first and second surgical components through the sterile barrier, such that the positioning is repeatable and deterministic.

[0014] US 2020 / 170724 A1 discloses a (robotic) fixation system for connecting first and second surgical components. The fixation system comprises a first and a second fixation section, a clamp that is movable between a first position and a second position, and a sterile barrier assembly.The sterile barrier assembly comprises a coupling configured to be detachably attached to the first mounting section and to detachably receive the second mounting section when the clamp of the second mounting section is in the first (open) position, and a plurality of kinematic couplings configured to engage the mounting sections and arranged to create a kinematic coupling between the mounting sections through the sterile barrier assembly to restrict six degrees of freedom of movement between the surgical components when the clamp of the second mounting section is in the second (holding) position.

[0015] DE 10 2015 207953 A1 discloses a particularly robust design of an electrical plug connection outside the medical field.

[0016] US 2020 / 069383 A1 discloses a driver interface for a robot arm of a surgical robot system comprising a drive element, an actuator, a housing with an opening for the drive element and a sterile cloth capture opening. Brief description of the Revelation

[0017] The purpose of disclosure is therefore to avoid or at least mitigate the disadvantages of the prior art. In particular, an electromechanical interface on an operating table, for example, for the repeated adaptation / separation of sterile application parts to non-sterile operating parts, should be safe, hygienic, and / or simple and therefore cost-effective.

[0018] This problem is solved, according to the disclosure, by a sterile barrier having the features of claim 1. Advantageous embodiments of the disclosure are the subject of the dependent claims.

[0019] The core concept of the present disclosure essentially consists of providing a simple sterile separation element (sterile barrier), for example in the form of a sheet, film, or cloth, and an electromechanical lock / coupling, with at least one contact pin arranged and designed such that it can be inserted / pierced into the sterile separation element from one side, like a pin, such that it protrudes from the other side of the sterile separation element. This ensures that the at least one contact pin is (directly) surrounded by the sterile separation element in a germ-tight manner, or that the sterile separation element is in a germ-tight seal around the at least one contact pin, wherein the contact pin can be contacted at at least one end / end section by a cable, for example by means of a socket or plug.

[0020] It should be noted at this point that the at least one contact pin can have two essentially identical rod / pin ends, such that two identical sockets with or consisting of corresponding socket- / sleeve-shaped contact elements can be plugged in on both sides. Alternatively, it is also conceivable to design the at least one contact pin with (two) different pin ends, in particular such that one end, preferably on the non-sterile side of the sterile separating element, is shaped as a (small-diameter) pin and the other end, preferably on the sterile side of the sterile separating element, is shaped as a (large-diameter) sleeve / socket.In this way, a type of socket / receptacle with a (large-diameter) sleeve-shaped contact pin can be inserted on one (non-sterile) side, and a type of plug / insert pin with a (small-diameter) pin-shaped contact pin can be inserted on the other (sterile) side into / onto the contact pin that penetrates the sterile separation element. The latter offers the advantage that, for example, electrical medical instruments on the sterile side, which are usually equipped with electrical cables and permanently attached cable plugs (with pin-shaped electrical contacts), can be electrically coupled to at least one contact pin (or its sleeve-shaped pin end) without additional (intermediate) adapters.The same applies to so-called extension cables on the non-sterile side, each of which has an end socket with at least one sleeve-shaped contact pin that can also be electrically coupled without an adapter to the pin end of the at least one contact pin inserted into the sterile separation element.

[0021] Preferably (alternatively or cumulatively), the at least one contact pin on one side of the sterile separation element is held in / by a first housing, which either forms a receiving slot for a socket and / or plug or from which at least one conductor is led out, which is fixed to the at least one contact pin. It should also be noted that it is not necessary for the same type of receiving slot or socket to be arranged on both sides of the sterile separation element, but that it is also possible to arrange a plug on one, preferably non-sterile, side of the sterile separation element and a socket on the other, preferably sterile, side.

[0022] Further preferably (alternatively or cumulatively), a second housing is provided on the other side of the sterile separation element, which is designed to be pressed against the first housing via the sterile separation element (as a sterile intermediate layer), whereby the at least one contact pin pierces the sterile separation element and projects into the interior of the second housing. The second housing can preferably be designed as a receiving slot, such that a further socket or plug can be inserted into the second housing and contacted with the at least one contact pin; and further preferably, the second housing is held in place by the contact pin and thus by the first housing.

[0023] Such a design is particularly simple, inexpensive and yet safe, and therefore especially suitable for disposable sterile drapes.

[0024] In other words, according to the disclosure, a planar, preferably flexible sterile element is provided for sterile separation. The sterile separation element is designed or configured to be arranged between, or fitted between, the first and second connectors / housings of a plug connection / electromechanical lock; and is thus designed or configured to create or effect sterile separation of the connectors.

[0025] The connector can preferably be a force-fit and / or form-fit connection. When connecting the first and second connectors / housings, the sterile separation element can preferably be located between the connectors, so that the sterile separation element adapts itself almost automatically to the geometric shape of the connector between the connectors.

[0026] Sterile separation can be understood here in particular to mean that sterile elements are separated from non-sterile elements in such a way that the sterile element is not contaminated at least at intended points of contact or at points intended for manual operation / touching.

[0027] Advantageous embodiments are claimed in the dependent claims and are explained in more detail below.

[0028] For example, the sterile separation element can be foldable and / or flexible. It can also be designed for single use, for example, as a disposable item. This allows for the simple provision of a safe and hygienic sterile separation tool.

[0029] The connector can be an electrical connector. One of the connectors of the connector can be male (contact pin), and the other connector of the connector can be female (socket).

[0030] The sterile separation element is designed to be penetrated by a number (or multiple) of the electrical contacts (contact pins) of the male connector. In particular, the sterile separation element may be designed to form an intermediate layer between the female connector / socket and the male connector (contact pin) during the mating process.

[0031] In an advantageous embodiment (alternatively or cumulatively), the sterile separation element can be dimensioned such that the flat element forms a sleeve over one of the connectors when in use. This allows the connector to be easily gripped without the risk of contamination.

[0032] The sterile separation element can be impregnated with a disinfectant (alternatively or cumulatively). For example, the disinfectant can be alcohol-based (ethanol or 2-propanol) and mecetronium ethyl sulfate. Additionally, the disinfectant can contain a moisturizing agent to prevent skin irritation. Thus, the flat element can function as a hand disinfectant wipe. The disinfectant can also contain one or more of the following substances: oxidizing agents, peracetic acid, hydrogen peroxide, halogens (iodine and chlorine compounds), ozone, phenol derivatives (including chloroxylenol and triclosan), aldehydes (e.g., formaldehyde), alcohols, detergents, nitrogen compounds (e.g., benzalkonium chloride), and similar substances (chlorhexidine, octenidine, polyhexanide). Therefore, the flat element itself can be sterile / germ-free.

[0033] The sterile separation element can also preferably (alternatively or cumulatively) be designed to form a sleeve up to a cable connected to the connector when in use. This allows personnel to easily operate / connect the connectors without contamination.

[0034] According to one or more embodiments, the sterile separation element can be a film, a cloth, or a sheet. The sterile separation element can be tear-resistant. At a minimum, the flat element can withstand a predetermined tensile force, for example, at least 1 N / mm² or 10 N / mm², i.e., be tensile-resistant. The flat element can also be designed for a maximum tensile force, for example, 15 N / mm² or 150 N / mm².

[0035] The non-sterile connector may, in particular (alternatively or cumulatively), have a mounting for attachment to an external, stationary object such as an operating table. This allows personnel to handle only sterile parts when connecting the sterile and non-sterile cables, for example, using the connector adapter or the flat element. Brief description of the characters

[0036] The disclosure is explained in more detail below with reference to a preferred embodiment and the accompanying figures. These show: Figure 1 is a schematic representation of a sterile barrier in the form of a sterile separation element with an electromechanical lock in a general representation or in a general basic structure to illustrate essential components of an arrangement according to the disclosure; Figure 2 is a schematic representation of a sterile barrier in the form of a sterile separation element with the electromechanical lock according to a first preferred embodiment of the present disclosure (with regard to the at least one electrical contact pin having two free pin ends), in particular designed as a sterile separation module; Figure 3 is a schematic representation of a sterile barrier in the form of a sterile separation element with the electromechanical lock according to a second preferred embodiment of the present disclosure (with regard to the at least one electrical contact pin having two free pin ends), in particulardesigned as a sterile separation module and Fig. 4 a general arrangement / subdivision of a sterile and non-sterile area. Character description

[0037] Fig. 1 shows a sterile barrier in a general representation or in a general basic structure to illustrate essential parts / components of an arrangement as disclosed, wherein the arrangement has: a flexible, preferably cloth- or sheet-like sterile separation element 1 (hereinafter simply referred to as sterile cloth); an electro-mechanical airlock 2 in / on the sterile cloth 1, comprising at least one electrical contact pin 9 that intermittently penetrates the sterile separation element 1; and a (first) bus of lines 5, consisting of a number / plural of lines / cables, leading to the airlock 2 in a non-sterile area, and a further (second) bus of lines 5, consisting of a corresponding number / plural of lines / cables, leading away from the airlock 2 in the sterile area.

[0038] Specifically, the sterile sheet 1 is a germ-proof fabric or film designed and constructed to separate a sterile area from a non-sterile area. For example, the sterile area could be an operating room containing a robotic arm or various drive and / or control devices / medical equipment, which in themselves constitute non-sterile areas and therefore must be hermetically sealed from the sterile area. For this purpose, such non-sterile areas can be surrounded / encased by the sterile sheet 1, while ensuring that, for example, electrical devices, power sources, or controls within the non-sterile area can maintain electrical contact through the sterile sheet 1 with (medical or surgical) equipment, such as surgical electromechanical handles, lighting devices, etc.in the sterile area without damaging / interrupting the germ-proof sterile barrier.

[0039] This basic structure or general basic structure corresponds to the arrangement according to the Fig. 4 , so that with regard to this, the foregoing description refers to the Fig. 1 Reference can be made to the electromechanical airlock 2 as disclosed, as described in more detail below, is provided for the purpose of maintaining sterility.

[0040] In principle, the electromechanical lock 2 according to the present disclosure has a number, preferably a plurality, of contact pins (lock contacts) 9, which are preferably mounted / fixed in a first housing (sleeve) 10, such that they protrude from the first housing 10 in a mandrel-like manner on one housing side (hereinafter referred to as the contact side). The contact pins 9 are arranged at a parallel distance from each other.

[0041] Each contact pin 9 has at least one free / protruding pin end or free end section that is designed and adapted to pierce the sterile wipe 1. For this purpose, one pin end of the corresponding contact pin 9 may, for example, be pointed or sharpened, or the contact pin 9 may have such a small diameter that it can pierce the sterile wipe 1 without tearing it. Crucially, a very narrow puncture hole is formed so that the inserted contact pin 9 is subsequently completely and hygienically surrounded by the sterile wipe 1.

[0042] Preferably, control electronics, for example, electronics 4 for controlling the battery of an electrical medical / surgical device located within the sterile area, or similar equipment, can already be located within the first housing 10. In this case, each electrical medical / surgical device within the sterile area is assigned a device-specific airlock 2, for example, with device-specific control elements or power supplies or the like, already within the first airlock housing 10.

[0043] According to the further aspect revealed in the Fig. 1 Each electrical contact pin 9 has a free end designed and configured to connect to a corresponding electrical socket 12 of at least one conductor 5 on the sterile or non-sterile side of the sterile separation element 1, forming an electromechanical or electrically conductive plug connection. At the other end of the pin, the at least one other conductor 5 is permanently connected to the corresponding other side of the sterile separation element 1. A conductor (cable) is attached to the other free end of each contact pin 9, forming a cable harness 5 that extends through an opening in the housing on the side opposite the installation area. This cable harness 5 is then electrically connected within the sterile area to a corresponding medical device (not shown).

[0044] Finally, in general (as shown by Figur 1 (as shown) a holder 6 is arranged / formed on the first housing 10, with which the first housing 10 can be fixed to a (stationary) fixed object, for example an operating table, in order to hold the airlock 2 and also the sterile cloth 1 in a fixed position.

[0045] On the side of the sterile cloth 1 facing away from the first housing 10, a second housing 11 is shown, which has an essentially hollow cylindrical / tubular shape, with one end face resting against the sterile cloth, and the sterile cloth 1 being sandwiched between the first housing 10 and the second housing 11. The free pin ends / end sections of the contact pins 9 (which have already been pushed through the sterile cloth 1) protrude into the interior of the hollow cylindrical second housing 11.

[0046] These free pin ends of the contact pins 9 are designed and configured to make electrical contact with contact sockets 12, to which wires / cables are also attached. These wires / cables are bundled together to form a cable harness 5, comparable to the cable harness 5 on the other side of the sterile cloth. Once these sockets 12 are plugged onto the free pin ends / end sections of the contact pins 9, they press the sterile cloth 1 against the contact surface of the first housing 10 located on the other side of the sterile cloth, thus holding the entire airlock assembly together.

[0047] It should be noted at this point that the in Fig. 1 The contact sockets 12 shown individually can also be combined into a plug whose shape is adapted to the hollow cylindrical second housing 12 in order to be able to be plugged into it.

[0048] The Fig. 2 shows a first embodiment of the present disclosure, whereby in the following essentially reference is made to, for example, the Fig. 1 different design features are addressed (all other above descriptions also apply to the first embodiment as disclosed); the same terms and reference numerals are used for identical components.

[0049] In this case, the first case 10, unlike the first case 10 according to the Fig. 1 (in accordance with the second housing 11) also a slot for a number of sockets or a plug 13 in which the sockets are grouped and which is adapted to the slot of the first housing 10. That is, in the first embodiment (or the modification) according to the disclosure Fig. 2 are the fixed line connections 3, as they are in the Fig. 1 shown, replaced by another plug connection, so that the contact pins 9 in this case have two free pin ends / end sections which are provided and designed for a plug connection with corresponding lines / cables.

[0050] Furthermore, in the first embodiment as disclosed, according to the Fig. 2 The bracket 6 for fixing the lock 2 to a (stationary) fixed object is not arranged / designed on the first housing 10, but on the plug 13. Furthermore, in the first embodiment according to the disclosure, the Fig. 2 That plug 8 is also now shown in a diagram, as it was previously used as a replacement / alternative for the one in Fig. 1 The sockets shown (number 12) were mentioned.

[0051] The disclosure relates in summary to a sterile separation element 1 for sterile separation, which is intended to be arranged between connectors 10, 11 of a plug connection / electro-mechanical lock and thus to provide sterile separation of the connectors 10, 11.

[0052] In Fig. 3 A second embodiment of the present disclosure is shown at least schematically, with only the differences to the first embodiment being described in more detail below.

[0053] As in the Fig. 2 As can be seen, the contact pins 9 are designed as uniform rods that form insertion ends on both sides of the sterile separation element 1, which can be inserted into sockets in the manner of a plug. This means that sockets must be provided on both sides of the sterile separation element 1, which can be brought into contact with plugs formed on both sides of the electrical / electromechanical airlock 2.

[0054] However, it has been shown that medical electrical instruments are already equipped with electrical cables, which usually already have plugs with simple contact pins attached. To connect these at lock 2 according to the Fig. 2 To connect it, an additional adapter would have to be provided. To avoid such an additional component, the second embodiment of the disclosure provides that, at least on the sterile side of the sterile separation element 1, the at least one contact pin 9 is designed at its end in the form of a sleeve / socket shape, such that the lock 2 on the sterile side of the sterile separation element 1 forms a kind of socket into which a plug with at least a single, simple contact pin can then be inserted, such as this one, for example, in the Fig. 1 This variant has the following advantages over the variant according to... Fig. 2 the advantage that a plug already present on the medical instrument can be brought directly into contact with the lock 2. Bezugszeichenliste

[0055] 1 Sterile separation element / sterile cloth / drape 2 Electromechanical airlock / sterile separation module 3 Fixed wiring connections / contacts 4 Electronics 5 Wiring harness / bus 6 Bracket 8, 13 Connectors 9 Contact pins / airlock contacts 10 First housing / connector 11 Second housing / connector 12 Sockets

Claims

1. Sterility barrier with a flat sterility separation element (1) in form of a covering or separation sheet, and an electro-mechanical lock (2), which is insertable / positionable or inserted / positioned in / on the sterility separation element (1), for the electrical connection of at least one electrical line (5) on the one, non-sterile side of the sterility separation element (1) to at least one electrical line (5) on the other, sterile side of the sterility separation element (1), the electro-mechanical lock (2) having at least one electrical contact pin (9), wherein the at least one electrical contact pin (9) has two freely projecting pin ends which are provided and configured to come into electro-mechanical or electroconductive plug contact with corresponding electrical pins and / or plug sockets (12) of the at least two lines (5) to be connected, characterized in that the at least one electrical contact pin (9) individually penetratingly enters the sterility separation element (1) when inserting / positioning the electro-mechanical lock (2) in / on the sterility separation element (1), such that the sterility separation element (1) fits directly to the at least one electrical contact pin (9) penetrating it, over its entire circumference in a germ-tight manner.

2. Sterility barrier according to claim 1, characterized in that the sterility separation element (1) is foil-like, drape-like, and / or plate-like.

3. Sterility barrier according to any of the preceding claims 1 to 2, characterized in that the electro-mechanical lock (2) forms an electro-mechanical coupling module with at least one first module housing (10) having a sterility separation element abutment side or abutment surface from which the one free pin end of the at least one electrical contact pin (9) projects freely.

4. Sterility barrier according to claim 3, characterized in that the first housing forms, on the housing side facing away from the abutment side, an insertion shaft into which the other free pin end of the at least one electrical contact pin (9) projects and into which the at least one plug socket (12) is insertable.

5. Sterility barrier according to any of the preceding claims 3 to 4, characterized in that the electro-mechanical coupling module has a second module housing (11) in form of a hollow cylinder which encloses an axially continuous insertion shaft and which is provided and configured to be abutted to the sterility separation element (1) on one end face such that the free end of the at least one contact pin (9), that has already penetrated the sterility separation element (1), projects into the insertion shaft of the second module housing (11), wherein, on the other end face, the plug socket (12) of the at least one other line (5) is insertable.

6. Sterility barrier according to any of the preceding claims 1 to 5, characterized in that the pin ends or pin end sections on one of the sides, in particular on the non-sterile side, form a male plug configured and adapted to be connected to a female plug socket of a cable.

7. Sterility barrier according to any of the preceding claims 1 to 6, characterized in that the pin ends or pin end sections on one of the sides, in particular on the sterile side, form a female plug socket provided to be connected to a male plug of a cable.

8. Sterility barrier according to claims 6 and 7, characterized in that the male plug and the female plug socket are of complementary form.

9. Sterility barrier according to any of the preceding claims 1 to 8, characterized in that a plurality of contact pins (9) is provided which are spaced apart in parallel, wherein a corresponding number of contact sockets (12) is provided on at least one side of the sterility separation element (1), which are preferably combined to form a single plug (8, 13).

10. Sterility barrier according to claim 9, characterized in that the first module housing (10) or the plug (13) is configured or equippable with a holder (6) which is provided and configured to be fixed to an external object, in particular an operating table.

11. System with a medical instrument, an energy source for the medical instrument and a sterility barrier according to any of the preceding claims 1 to 10, wherein the electro-mechanical lock (2) of the sterility barrier arranged in form of an intermediate plug between the medical instrument and the energy source, preferably in a sheet-like or foil-like sterility separation element (1).