Surgery tent having an inspection window

Abstract

The invention relates to an expandable surgery tent for providing an enclosed, sterile environment around a surgical site, comprising: a first film layer with an inspection window opening, and an inspection window. The invention is characterised in that the inspection window is bonded by means of an adhesive tape which is arranged between a region extending along a rim of the inspection window and a peripheral region, encircling the inspection window opening, of the first film layer, and is cohesively bonded by means of a weld seam extending along the outline of the inspection window opening, wherein the weld seam extends, in cross section, over the inspection window, the adhesive tape and the first film layer.

Description

[0001] Surgical tent with viewing window

[0002] The invention relates to an expandable surgical tent for providing an enclosed, sterile environment around a surgical site, comprising: - a first film layer with a viewing window recess and a viewing window. A second aspect of the invention is a method for welding two film layers, in particular for welding a film layer and a viewing window made of different plastics, and a device for such welding.

[0003] Surgical tents are already known in various designs. They must first be fundamentally distinguished from purely sterile barrier systems such as operating room, equipment or instrument table covers and surgical gowns, which provide a barrier between non-sterile and sterile areas. These flat covers offer protection over a certain lateral extent, but do not demarcate any adjacent airspace on all sides in the sterile area. These covers can therefore only function effectively in conjunction with controlled air hygiene above the sterile areas, as well as the ambient air, and other extensive hygienic, structural and organizational measures. The requirements for sterile operating room / orEquipment or instrument table covers and surgical gowns are regulated in Europe by EN 13795 and in the USA by ANSI / AAMI PB70. Most other countries have similar or comparable regulations. The requirements and classification of the necessary airspace technology are also regulated in most countries according to the invasiveness of the procedures.

[0004] Operating rooms, equipment and instrument table covers, and surgical gowns are not the subject of this invention. Surgical tents, on the other hand, are designed to create a sterile environment around a patient's body area by means of a barrier system acting in all directions, as well as integrated or connected air filter technology. According to the invention, a surgical tent has an interior volume that can accommodate an extremity, a body section, or even the entire body of a patient, or that has a suitable interface for a contact area with the patient's skin section in the area of ​​the planned surgical procedure. This can be a flat interface, for example, to perform surgical procedures on the torso, or an enclosure to perform surgical procedures on extremities.The user, i.e., the surgeon or surgical assistant, reaches into the surgical room enclosed by the surgical tent with one or two hands to perform the operation. The user therefore stands or sits outside the surgical tent in a non-sterile area. In such surgical tents, a space in which the surgeon can work with his or her hands and which is immediately adjacent to the surgical site must be placed in sterile conditions and maintained in this sterile condition throughout the entire surgical procedure, corresponding to the conditions surrounding the operating area in a surgical room.

[0005] For this purpose, it is generally known to provide a surgical chamber with a rigid, non-collapsible wall that can create a stable separation of the internal sterile area from the non-sterile environment. However, such surgical chambers have the disadvantage of being bulky and voluminous, and therefore lack the key advantages of surgical tents, namely their easy transportability in a compact form and space-saving storage.

[0006] Surgical tents in the narrower sense, on the other hand, are generally collapsible into a compact form, allowing them to be transported and stored in a space-saving manner. This is crucial for the logistical processes in medical facilities, taking advantage of the advantages of surgical tents, such as the small space required for storage when transported compactly, the ability to perform surgical procedures under sterile conditions in remote locations, and the ability to easily transport the necessary equipment there. Even when surgical tents are used in hospitals for outpatient procedures, it is necessary to be able to store the surgical tents, which are regularly used as disposable products, in a space-saving manner in order to ensure that the daily and weekly supplies required for performing the procedures can be maintained using the surgical tents.

[0007] These collapsible surgical tents are essentially characterized by a flexible, collapsible wall that must be suitably expanded to create and maintain the internal space for the surgical procedure. A fundamental distinction must be made between two principles that differ both functionally and, in many countries, are subject to different requirements for approval as a medical device. The first type of surgical tent is based on the principle that the interior of the surgical tent is pressurized relative to the ambient air by injecting a gas, thereby bringing the surgical tent into an expanded state.While these types of surgical tents generally do not require any stiffening elements in the tent walls, they frequently feature such stiffening elements, for example, to allow the surgical tent to assume a specific shape under the influence of internal pressure. A disadvantage of this type of surgical tent design, however, is that, due to unavoidable pressure losses, which may occur, for example, when instruments, biopsy material, or the like are being moved in or out, a certain amount of gas can escape from the interior. Thus, gas must be continuously supplied to maintain the necessary overpressure inside the surgical tent. Furthermore, the internal pressure must be monitored, which is complex and error-prone in terms of control technology.Surgical tents of this type rely on a reliable, sterile supply of gas or sterile air via an electric pump and are therefore subject to strict requirements for approval as a medical device for surgical procedures in many countries. A further disadvantage of this design is that surgical instruments, such as compressed air-driven instruments or suction devices, are often operated with compressed air or negative pressure. This can significantly affect the overpressure level inside the surgical tent, leading to damage to the surgical tent or a loss of the necessary internal pressure.Therefore, high demands are placed on the necessary control of the internal pressure, the control speed and the available control volume both with regard to the supply of gas and the removal of gas from the interior of the surgical tent in order to avoid damage to surgical tents of this type.

[0008] A second type of surgical tent is based on the principle of stabilizing the tent walls in an expanded state, allowing the tent to be used in an operating state where the pressure inside the tent corresponds to the ambient pressure. This design avoids the need for a continuous supply of sterile gas with pressure monitoring to maintain the expanded state of the surgical tent and is therefore independent of a corresponding gas supply. This type of surgical tent is therefore subject to lower requirements for approval as a medical device for surgical procedures in many countries, as no electrically operated pumps or hygienically safe gases are required to ensure operation with a sterile interior atmosphere.

[0009] US 2014 / 0163326 A1 discloses various designs of surgical chambers and surgical tents. These include surgical chambers with rigid, non-collapsible walls, as well as designs with collapsible walls stabilized by an elevated internal pressure generated by a gas cylinder. In addition to the fundamental disadvantages of such designs with rigid walls or those stabilized by elevated internal pressure, as already explained above, this device has the additional disadvantage that, due to the exhaustion of the gas supply in the gas cylinder, its function can be unexpectedly impaired, even during an operation, to such an extent that the operation cannot be continued.

[0010] WO 1986 / 006272 A1 describes an isolator for creating a sterile local environment on a patient, wherein a patient body part to be surgically treated can be inserted into the interior of the isolator through an incision in a lower film of the isolator. The isolator is constructed as an inflatable bag made of a flexible material and is held in the required expanded shape by an overpressure within the bag. This overpressure is created and maintained by a continuous flow of filtered air from a pump device. This device therefore also has the disadvantages explained above; in particular, it must be ensured that the continuous air flow does not introduce contamination and that the pump operates flawlessly and reliably during the operation in order to safely complete the operation.

[0011] US Pat. No. 7,037,254 B2 discloses a device for creating a controlled environment in the area of ​​an incision site during a surgical procedure to prevent oxygen poisoning. For this purpose, a sterile gas such as nitrogen or argon is introduced from a pressure cylinder into a collapsible enclosure mounted above the surgical site, and a controlled overpressure is maintained within the enclosure by means of a corresponding pressure control valve and pressure regulator.

[0012] US 6,793,617 B2 describes a collapsible and inflatable examination unit with a cubic shape and inflatable tubes extending along all edges, forming an inflatable air tube frame. Gloves are incorporated into one side wall, allowing a surgeon to access and handle instruments inside the cube. In practical use, this device has shown the disadvantage that handling objects with gloves causes deformation of the entire cube and its walls, which complicates visual observation through the walls, and the stability of the frame is insufficient to perform more complex surgical operations inside the cube under reliable pressure conditions.

[0013] EP 3 236 865 B1 discloses a surgical tent for creating a limited sterile area around a surgical site on a body. The device comprises a frame structure with a multi-layer film arrangement designed for attachment to the skin surface and for disinfecting the skin surface prior to the surgical procedure. A collapsible tent structure is attached to this frame, which can be expanded and held in an expanded form by means of tube structures that can be pressurized or filled with a curable foam. This prior art proposes a stabilizing frame structure made of internally pressurizable, curved tubes, in which several C-shaped tube segments are connected to one another at one end and at a convex-shaped central section in order to stabilize the surgical tent in the expanded position.It has been shown that such a configuration of the surgical tent and the stabilizing tubes can be further improved to be suitable for a variety of different surgical procedures and purposes, while providing good stability in the expanded form of the surgical tent. A sterile tent with inserted windows is previously known from US 2008 / 0041399 A1. The windows are attached either by robot-assisted infrared welding or by other conventional means, such as preferably by gluing in an outer edge area of ​​the window. However, according to the inventors' findings, a disadvantage of this previously known design is that, for geometrically precise welding, the correct positioning of the film layers and windows relative to one another must be established and ensured throughout the continuous welding process.In contrast, bonding the window requires a carefully measured and limited application of the required adhesive to the overlapping adhesive edges of the window and film. The window must then be precisely positioned against the film in the desired position. If subsequent positioning adjustment is possible, the window must be held in exactly this position during the curing phase of the adhesive. If subsequent positioning adjustment is not possible, the two parts must be initially placed in exactly the correct position. This process is technically very complex and error-prone, and therefore often results in a manufacturing defect in an area particularly relevant for later use, leading to rejects.

[0014] DE 2 411 387 A and US 5,679,208 A describe devices and methods for welding two films by means of heat input generated electrically via a resistance heater.

[0015] A fundamental problem with this type of surgical tent is ensuring good optical quality for the surgeon's view from outside the surgical tent into the sterile interior of the surgical tent. While optically clear and transparent plastic films are known, they are often stiff, and the quality of the optical image is significantly impaired by kinks and deformations. In principle, surgical tents maintained in their expanded form according to the aforementioned principle can exert a flat force on the film layer by means of an internal pressure that is higher than the ambient pressure, which is beneficial for optical quality and dimensional stability.However, as soon as this internal pressure can no longer be maintained, or in surgical tents stabilized according to the aforementioned second principle and not exhibiting an internal pressure higher than the ambient pressure, thin-walled plastic films, which would be advantageous for folding, cannot achieve sufficiently good optical quality to allow the surgeon to perform complex procedures inside the surgical tent while simultaneously observing from outside the surgical tent. The invention is therefore based on the object of providing a surgical tent that solves these problems regarding the quality of observation of the surgical treatment by the surgeon from outside the surgical tent into the interior of the surgical tent.

[0016] This object is achieved according to the invention in an expandable surgical tent of the type explained above in that the viewing window is materially connected to the viewing window along an outline of the viewing window recess by means of a pressure-sensitive adhesive tape and by means of a weld seam running along the outline of the viewing window recess, wherein the weld seam extends in cross section over the viewing window, the first film layer and the pressure-sensitive adhesive tape.

[0017] The surgical tent according to the invention has a manufacturing configuration characterized in that this manufacturing configuration is created by joining the first and second film layers, and optionally additional film layers. The manufacturing configuration is therefore a configuration in which the film layers are generally arranged flat on top of one another, and the structure of the manufacturing configuration is created simply by joining, folding, or cutting the two or more film layers. It should be understood that the surgical tent itself may also have additional components, for example, valves, windows, or the like.

[0018] From its production configuration, the surgical tent can be converted into a compact transport configuration. The packed volume of this transport configuration is smaller than the surgical space enclosed by the surgical tent in its expanded surgical configuration. The transport configuration is typically created from the production configuration by folding or rolling the film layers once or several times. Before creating the surgical configuration by filling the stabilizing element, it is often advantageous to unfold / unroll the surgical tent from this transport configuration. The expanded surgical configuration is the configuration in which the surgical tent can be used to perform an operation.This expanded surgical configuration is created by stiffening the stabilizing elements by filling them with a fluid and pressurizing them, thus stabilizing them like pressurized tubes or hoses. The stabilizing elements, which are created by connecting the film layers and are therefore integral parts of the film layers, thus create an uprighting and stabilizing effect on the surgical tent, similar to a tent frame.

[0019] The filling of the surgical tent during expansion can occur through corresponding openings in a wall of the surgical tent. In particular, it is preferred if the surgical tent encloses the surgical room in a fluid-tight manner and one or more openings are provided in the wall of the surgical tent through which air or a gas can flow into the surgical room, preferably passively. These openings can preferably be provided with filters so that the air flowing through the opening is filtered and freed of germs and contaminants in order to create a sterile atmosphere in the surgical room. For example, so-called HEPA filters can be used for this purpose.

[0020] In principle, a film layer can be formed by a first and a second film and, if necessary, further films. It should be understood that the first film and the second film can, in principle, be part of an upper film arrangement, a lower film arrangement, or part of both film arrangements, for example, by forming the upper and lower film arrangements from two films each. According to the invention, the first and second films are not to be understood as a continuous film as the starting material; rather, the first and second films can also be formed by an arrangement of several film sections that are welded together or connected in some other way.

[0021] Fundamentally, a stabilizing element is preferably formed by connecting two or more superimposed films along two linear connecting lines, which run spaced apart from one another and form a fluid-fillable volume between them. This connection can be achieved, for example, by linear welding. The stabilizing element is thus a component of the films, and the films form a single or multiple film wall in the area adjacent to the fluid-filled volume, which achieves the stiffening effect. The films adjacent to the stabilizing element as a double or multiple film layer are shaped by the directly structuring contour of the stabilizing element into a shape—the desired surgical configuration.

[0022] According to the invention, the surgical tent comprises a first film layer which, on its own or together with other film layers, encloses the interior of the surgical tent. It also comprises a viewing window which is fastened in a viewing window recess in the first film layer. This basic structure makes it possible, on the one hand, for the first film layer and optionally further film layers to be made from a material which is easy to fold, mechanically insensitive to folding, and has reduced requirements for optical quality. A film layer can be composed of a single film or of two or more films laid on top of one another. In the area of ​​the viewing window, the first film layer is provided with a viewing window recess, i.e. an opening which is made in the first film layer, for example by punching or cutting.The first viewing window is connected to the first film layer in such a way that it closes this viewing window recess. This ensures the tightness required to maintain the sterility of the interior and at the same time allows the viewing window to be made of a material of higher optical quality than the first film layer. By extending the viewing window over the viewing window recess, the viewing window has a limited geometric dimension, which either makes it possible to avoid the need for the viewing window of the surgical tent to be folded or bent in order to bring the surgical tent into a compact position, or the viewing window can be arranged when compacting the surgical tent so that it only undergoes a fold with such a large radius that this does not impair the optical quality of the viewing window.The viewing window is attached to the first film layer in the area of ​​the viewing window recess using a pressure-sensitive adhesive tape. Such a pressure-sensitive adhesive tape can, in particular, be a double-sided pressure-sensitive adhesive tape, i.e., one formed by a strip that exerts an adhesive effect on both sides. Using this pressure-sensitive adhesive tape, the viewing window is bonded along its edge to an edge region of the viewing window recess. Preferably, the pressure-sensitive adhesive tape is bonded along the entire peripheral edge region of the viewing window recess to the first film layer and, accordingly, to the edge of the viewing window, in order to create a seamless connection between the viewing window and the first film layer. This bonding allows the viewing window to be bonded to the first film layer in a manner that is easy to implement from a manufacturing perspective, without creases or tension.The adhesive strength of the pressure-sensitive adhesive tape preferably allows an existing bond to be released again in order to resolve any creases or tensions that may have occurred. The specific bond created by the pressure-sensitive adhesive tape therefore enables a wrinkle-free connection between the first film layer and the viewing window, which is necessary for optical quality. The connection between the viewing window and the first film layer further comprises a weld, which, according to the invention, is understood to be a material-to-material bond created by fusing the welded materials. This weld extends through the viewing window, the pressure-sensitive adhesive tape, and the first film layer, thus firmly connecting these three elements.The welding creates a highly resilient bond between the viewing window and the first film layer, incorporating the pressure-sensitive adhesive tape, so that the pressure-sensitive adhesive tape cannot cause any adverse long-term leakage. Therefore, according to the invention, the pressure-sensitive adhesive tape does not need to exert the adhesive force required for the stable bond between the viewing window and the first film layer, but only the adhesive force required for precise, wrinkle-free positioning and maintaining this positioning during the welding process. This adhesive force can, in particular, be lower than the bonding force between the viewing window and the first film layer generated by the welding.The inventive design of the connection between the viewing window and the first film layer reliably prevents potential tensions and displacements during the welding process, which could lead to wrinkles between the viewing window and the first film layer, because the pressure-sensitive adhesive tape maintains the positioning between the viewing window and the first film layer throughout the entire welding process. If necessary, a lamination on the window or pressure-sensitive adhesive tape can be provided to facilitate the positioning and movement of the individual elements to be bonded and welded. Such a lamination can then be welded as a fourth layer, if necessary, so that this lamination does not need to be removed in the connection area.

[0023] According to a first preferred embodiment, the viewing window is made of a first material and the first film layer is made of a second material that has a lower melting point than the first material. According to this development, the viewing window and the first film layer differ in terms of their material properties, their melting point, and their melting temperature - the melting temperature of the first film layer is lower than that of the viewing window. Basically, this material difference is made possible by the specific type of connection between the viewing window and the first film layer, since the pre-established adhesion by means of the pressure-sensitive adhesive tape allows the welding to be controlled in such a way that even two materials with different melting temperatures can be reliably welded together.Fundamentally, it should be understood that the viewing window and the first film layer can differ in terms of material thickness, optical quality, color, material type, and thus mechanical strength, melting temperature, and elasticity. According to the invention, each of these properties can be different between the viewing window and the first film layer. In particular, the method of connection also allows the first material of which the viewing window is made to have a higher melting temperature than the second material of which the first film layer is made, while at the same time allowing the viewing window to have a greater material thickness than the first film layer.

[0024] It is even more preferred if the pressure-sensitive adhesive tape comprises a carrier material whose melting temperature lies between the melting temperature of the first and second materials. According to this embodiment, the pressure-sensitive adhesive tape has a carrier material, which is understood in particular to be a strip material that is coated on one or both sides with an adhesive or has adhesive properties. This carrier material has a melting temperature that lies between that of the viewing window and the first film layer. This melting temperature results in a particularly advantageous welded connection between the viewing window and the first film layer through welding.Deviating from this embodiment, it is also possible with the inventive design of the surgical tent to achieve a weld between the viewing window, the pressure-sensitive adhesive tape and the first film layer if the pressure-sensitive adhesive tape has a melting temperature which is lower than that of the first material and also lower than that of the second material or which is higher than that of the first material and the second material.

[0025] It is even further preferred if the viewing window has a greater wall thickness than the first film layer. The design of the viewing window with a greater wall thickness than the first film layer is made possible by the inventive connection using pressure-sensitive adhesive tape and welding and also allows a significant improvement in the optical quality for observation through the viewing window. Due to the lower wall thickness of the first film layer, movements of the surgical tent during the execution of the operation, which can be caused, for example, by the surgeon reaching through arm openings, are primarily absorbed by the thinner first film layer, thereby relieving the load on the viewing window and avoiding or significantly reducing deformation of the viewing window. This consequently avoids optical distortions that would occur if the viewing window were to deform.In this case, the wall thickness of the first film layer is understood to be the sum of the wall thicknesses of these films, if the first film layer comprises several films.

[0026] It is even more preferred if the viewing window is made of PET or comprises PET and the first film layer is made of EVA or comprises EVA. Polyethylene terephthalate (PET) is a semi-crystalline plastic that can be produced with such a low degree of crystallization that films made from it, up to a thickness of several millimeters, have very good light transmission for optical observation. PET is readily available in film form and can also be easily recycled. According to the inventors' findings, PET films with wall thicknesses of less than 1 mm already have sufficient mechanical properties for the purposes of a viewing window in the surgical tent according to the invention and form an inherently rigid window design, are insensitive to kinking, and offer a distortion-free image.

[0027] Ethylene-vinyl acetate (EVA) is a plastic material consisting of a copolymer of ethylene and vinyl acetate. The properties of EVA can be influenced by the mixing ratio of the two polymer components, ethylene and vinyl acetate. By adding up to 7% vinyl acetate, the elongation at break can be increased, which the inventors believe is advantageous for use in surgical tents, where temporary high stresses due to elongation are present. If the vinyl acetate content is increased above 7% (up to 90%), this effect can be further enhanced; at vinyl acetate contents above 30%, EVA exhibits rubber-like properties and is considered a thermoplastic elastomer. EVA is available in film form.

[0028] PET is used in medical applications, for example, as a vascular implant, and EVA is used as an additive in cosmetics in the form of micropellets. Therefore, both materials are safe for use in the production of a surgical tent. PET has a melting point of approximately 250°C to 260°C, while EVA has a melting point of approximately 150°C. EVA can also be produced in a semi-crystalline and transparent state. As a film, it then exhibits sufficient light transmission for lighting purposes, while also exhibiting a certain optical quality.The production of the surgical tent with a viewing window made of PET and the other wall elements made of EVA therefore has the advantage that the wall surfaces allow light to enter the interior of the operating room and a basic assessment of the position and orientation of body parts and instruments is possible, and the PET viewing window allows high-quality optical observation of the surgical procedure in the interior of the operating room.

[0029] It is further preferred if the viewing window and the first film layer are made of uncolored plastic, in particular if they are transparent. While manufacturing from uncolored plastic complicates certain manufacturing and processing methods that rely on the absorption of high-energy radiation, the properties of the surgical tent are significantly improved, particularly with regard to the previously described lighting situation and observation possibilities in the entire operating room, i.e., the sterile environment enclosed by the surgical tent around the surgical site. It is particularly preferred if the first film layer or all film layers are made of uncolored plastic, in particular transparent plastic.

[0030] It is even further preferred to further develop the surgical tent by at least one stabilizing element formed by a connection of the first and a second film layer, which, through the connection, delimit an inner, closed cavity that can be filled with a fluid, wherein the surgical tent can be brought from a production configuration into an expanded surgical configuration, wherein in the production configuration the stabilizing element is flexible and foldable and the surgical tent can be folded into a flat, transportable package with a packing volume, and in the expanded surgical configuration the surgical tent encloses an interior operating space with a volume that is larger than the packing volume, and the stabilizing element can be set into a stiffer state than in the production configuration by filling the cavity and stabilizes the expanded surgical configuration in a compressed state,in which the air pressure in the operating room inside the surgical tent and in the area outside the surgical tent is the same.

[0031] The design of the surgical tent according to the invention with this configuration, with a stabilizing element that is flexible in an unfilled or partially filled state and can be folded, and that can be brought into a pressurized state by filling it with a material, in particular fluid filling, for example with air, and then exerts a stabilizing effect, for example in the form of a stiffened tube, is advantageous for providing the surgical tent from the first film layer and the viewing window. The first film layer can be connected to a second film layer, for example along two spaced-apart lines, in order to form the stabilizing element as a closed, essentially tubular cavity between the two lines. The viewing window can preferably be arranged on an upper side of the surgical tent.This design allows the surgical tent to achieve such self-supporting stability that it can be used without increased internal pressure. It is particularly advantageous for this purpose if the stabilizing element is formed by several branched, tubular sections and / or if several

[0032] Stabilization elements are designed on the surgical tent.

[0033] The stabilizing elements can be formed, in particular, from the first and second film layers in such a way that these two film layers, on the one hand, form wall sections of the surgical tent, and, on the other hand, form stabilizing elements that are formed by creating a hollow space between the two film layers, for example, by welding the first and second film layers. Each film layer can be formed by one or more films; for example, the first and second film layers can each be formed by two superimposed films. Such a design achieves good foldability while simultaneously providing high mechanical strength and security against possible punctures due to the redundancy of the multiple films.

[0034] A further aspect of the invention is a method for joining two plastic film layers, comprising the steps of: arranging the two film layers such that they overlap one another at least along a connecting line, placing a contact element on the upper film layer of the film layers, moving the contact element along the connecting line, and introducing thermal energy along the connecting line to weld the film layers, which is characterized in that the movement of the contact element occurs by rolling the contact element along the connecting line, and the introduction of the thermal energy occurs by passing an electromagnetic beam through the contact element. The method according to the invention is particularly well suited for joining two film layers made of a different material and / or of different material thickness.The rolling motion of the contact element allows a high contact pressure to be applied by the contact element, thereby pressing the two foil layers firmly together along the connecting line. The action of the electromagnetic beam directly through the contact element allows the thermal energy to act directly on the connecting line, thus using an advantageous combination of contact pressure and heat to bond the two foil layers. A laser, for example, is suitable as an electromagnetic beam and can be operated with constant irradiation or in a pulsed mode. The contact element is particularly made of a material that is permeable to electromagnetic radiation with little or no loss; in the example case of a laser beam, a contact element made of glass can be used, in particular.The method can be advantageously further developed by using a rotationally symmetrical body, in particular a sphere, as the contact element. A rotationally symmetrical body, in particular a sphere, allows for a constant contact pressure when moving the contact element along the connecting line and can exert the high contact pressure while avoiding shear forces. A spherical contact element, in particular, allows for the formation of a connecting line with changes in direction without the need to pivot the orientation of the contact element itself to adapt to a different orientation of the connecting line.

[0035] It is even more preferred if the contact element comprises or consists of a material that is transparent to light. Such a transparent material significantly reduces losses during the transmission of the electromagnetic beam, especially if the beam has a wavelength in the visible light range.

[0036] It is even more preferred if the electromagnetic beam is a laser beam. A laser beam allows for concentrated energy input in a small space and is insensitive to distance fluctuations and varying material thicknesses, as the laser beam has a constant beam cross-section along its entire length.

[0037] It is particularly preferred if the contact element is a glass sphere and the electromagnetic beam is a laser beam in the visible wavelength range. The combination of a glass sphere and the introduction of thermal energy as a laser beam allows for particularly efficient process control and the bonding of two or more film layers, each composed of one or more films. The visibility of the laser beam also allows the process to be easily observed by an operator of a device carrying out the process, enabling effective quality control.

[0038] It is even more preferred if the film layers are supported on a support surface made of a plastic and the plastic of the support surface has a higher melting temperature and / or lower absorption rate for the wavelength of the electromagnetic beam. By supporting the film layers on a plastic support surface, a certain flexibility and indentation capacity of the support surface can be achieved under the action of the contact pressure of the contact element. This makes it possible to define the strength of the connecting line along which the pressing effect between the two film layers is achieved. The parameters to be set here are a radius of the contact element in the contact pressure area, an elasticity of the support surface, which is formed by the elastic properties of the plastic material, and the thickness of the plastic material of the support surface.The support surface can, in particular, be formed by a plastic layer on a metal support surface in order to combine the necessary geometric precision and rigidity with the desired low degree of compliance. Configuring the plastic with a higher melting temperature and / or lower absorption rate ensures that the plastic is not melted by the effects of electromagnetic radiation. Therefore, the electromagnetic radiation can be adjusted within an intensity range that effectively fuses the two film layers while avoiding melting the support surface. It should be understood that the intensity is determined by the energy density of the laser beam and the traversing speed of the laser beam.

[0039] It is even more preferred if the film layers are welded along a first connecting line in a first step and welded along a second connecting line in a second step, which is at least partially, preferably completely, enclosed by the first connecting line. This procedure has the advantage that the first connecting line in the first step connects the two film layers to one another in an initial, preferably wrinkle-free arrangement. The second connecting line or further connecting lines, which are then implemented within this first connecting line in the second and subsequent steps, can thus be implemented on two film layers that are stabilized relative to one another, so that warping and the formation of folds are significantly reduced or completely avoided.The first connecting line can in particular be curved, for example run along a circumference of a product to be manufactured and in particular trace the outline of the product.

[0040] It is even more preferred if the film layers are adhesively connected to the support surface along the first connecting line in the first step. An adhesive connection of the first connecting line to the support surface advantageously ensures that the two film layers cannot easily slip during the subsequent production steps, thus enabling precise production that can be carried out even under the influence of slight shear and friction forces on the film layers. The adhesive connection fixes a specific arrangement of the two film layers, for example a crease-free arrangement of the two film layers on the support surface or an arrangement of the two film layers folded on top of one another in a specific way, thereby facilitating the subsequent processing steps and thus increasing their precision.Adhesion can be achieved by creating a low adhesion force along the first connecting line, which is lower than the bonding force generated between the two film layers along the first connecting line. This adhesion force can be overcome in a step following the creation of the first, second, and optionally further connecting lines when the two film layers are removed from the support surface, without causing damage to the film layers. It has been shown that a support surface made of a plastic material such as silicone or silicone-containing plastics is particularly suitable for this purpose.

[0041] It is even further preferred if the method is further developed in that the film layers are bonded together before welding using a double-sided adhesive tape, and the weld extends in cross-section through the first film, the adhesive tape, and the second film. By connecting the two film layers before welding using a double-sided adhesive tape, a desired positioning of the two film layers is fixed in advance and can subsequently be further processed into a permanent and resilient connection by welding. The connection with a double-sided adhesive tape also allows two film layers made of different materials and / or different material thicknesses to be reliably joined together by welding in a favorable manner; the adhesive tape is used as an additional element that moderates the welding.

[0042] Finally, a further aspect of the invention is a device for welding two plastic film layers, comprising: a contact element movable along a connecting line for placing on the film layers, an energy source for introducing thermal energy along the connecting line for welding the film layers, in which the contact element is rotatably mounted in a bearing and is designed to be moved by rolling the contact element along the connecting line, and the energy source is a beam emitter of an electromagnetic beam, and the electromagnetic beam emitted from the beam emitter is directed onto the contact element and is guided by the contact element to the connecting line of the film layers.The device according to the invention is particularly well suited for carrying out the above-described method according to the invention and for establishing a connection between two film layers for an expandable surgical tent of the type described above. The device can be further developed by the contact element being a rotationally symmetrical body, in particular a sphere.

[0043] The device can be further developed in that the contact element comprises a material that is transparent to light or consists of such a material.

[0044] The device can be further developed in that the beam emitter is a laser beam source and the electromagnetic beam is a laser beam.

[0045] The device can be further developed in that the contact element is a glass sphere and the beam emitter is a laser beam source for emitting a laser beam in the visible wavelength range.

[0046] The device can be further developed by a support surface made of a plastic which has a higher melting temperature and / or lower absorption rate for the wavelength of the electromagnetic beam than the two film layers, and characterized in that the beam emitter is designed to emit the electromagnetic beam with such an energy density that the lower film layer is detachably and adhesively connected to the support surface in the region of the connecting line.

[0047] With regard to the design of the device according to the invention for welding two film layers and the components contained in this device, their design and function, reference is made to the above description of the method according to the invention for joining two film layers made of plastic.

[0048] Preferred embodiments of the invention are explained with reference to the accompanying figures. They show:

[0049] Figure 1 ah: a schematic representation of the manufacturing steps for a surgical tent according to the invention,

[0050] Figure 2a-f: A schematic representation of the process of manufacturing and erecting a surgical tent according to the invention with a structure of the stabilizing elements according to a first embodiment, Figure 3a-g: a schematic representation of the process of manufacturing and erecting a surgical tent according to the invention with a structure of the stabilizing elements according to a second embodiment,

[0051] Figure 4a-g: a schematic representation of the process of manufacturing the erection of a surgical tent according to the invention with a structure of the stabilizing elements according to a third embodiment,

[0052] Figure 5a-e: an embodiment of a support structure with kinks according to the invention for the surgical tent according to the invention,

[0053] Figure 6a-c: a schematic representation of a section of the surgical tent according to the invention with a viewing window and the process of connecting the viewing window to a film layer according to a first embodiment, and

[0054] Figure 6d-f a schematic representation of a section of the surgical tent according to the invention with a viewing window and the process of connecting the viewing window to a film layer, according to a second embodiment

[0055] Figure 7a-d: an embodiment of the surgical tent according to the invention with a sleeve construction according to the invention according to a first embodiment

[0056] Figure 8a-d: an embodiment of the surgical tent according to the invention with a sleeve construction according to the invention according to a second embodiment,

[0057] Figure 9a, b: a schematic representation of a double valve connection for filling the support structures of a surgical tent according to the invention, and

[0058] Figure 10a, b: a schematic representation of a double valve arrangement for filling the support structures of the surgical tent according to the invention according to a second embodiment.

[0059] Figure 11 ah: A schematic representation of the process of manufacturing and using a surgical tent according to the invention with an extremity disinfection hose,

[0060] Figure 12 ah: a second embodiment of an extremity tube,

[0061] Figure 13: A schematic, partially sectioned view of a cutting knife according to the invention for cutting one or more film layers for a surgical tent, Figure 14a-c: A schematic, longitudinally sectioned view of a stabilizing element with redundancy against damage from both sides,

[0062] Figure 15a-j shows an elastically deformable ring according to the invention for connecting and sterile changing a glove to a sleeve of the surgical tent,

[0063] Fig. 16a-d a schematic representation of the manufacturing sequence of a surgical tent according to the invention,

[0064] Fig. 17a-c a schematic representation of a line hose for sterile removal of a line from the surgical room,

[0065] Fig. 18a,b a schematic representation of a surgical tent according to the invention with ventilation hose,

[0066] Fig. 19 ad a schematic representation of a germ-tight detachable hose connection for connecting equipment such as an extremity hose, a line hose or a sterile container hose to the surgical tent according to the invention, and

[0067] Fig. 20a-l a schematic representation of a sterile container tube according to the invention.

[0068] Figure 21 a - f: A schematic representation of an integrated adapter for the introduction of batteries or accumulators in power tools, according to a second embodiment of a separate introduction bag for instrument containers to the surgical tent according to the invention

[0069] Figures 1a-h schematically illustrate the manufacturing sequence for a surgical tent according to the invention. The starting point is two film layers 10, 20, which, for example, as shown in Figure 1a, can be formed as film layer 10 from two superimposed films 10a, b and are available, for example, as wound roll material. From these two film layers 10, 20, an upper film layer 10 and a lower film layer 20 are formed, as shown in Figure 1b. Both film layers 10, 20 are first joined together along predetermined lines 11, 12, 21, 22, which can be done in particular by welding.For example, two viewing windows 13, 14 can be welded into the upper film layer 10, a connecting section 23 for sterile placement of the surgical tent on a skin surface can be formed in the lower film layer 20, and stabilizing elements 15, 25 in the form of tubular sections can be formed in both film layers. The two film layers 10, 20 can essentially be constructed identically—apart from the different weld line geometry—and the film layers can each contain 2, 3, 4, or more individual films arranged one on top of the other.These films can be made of the same material and of the same thickness; however, in certain applications, films of different material types and / or thicknesses can be bonded together, or different film layers can be used for the upper and lower film layers. The film layers are preferably made of EVA films. The viewing window welded into the upper film layer is preferably made of a different material, for example, PET.

[0070] During welding, each of the two film layers rests on a support surface 1 made of a material with a higher melting point than the material of the film layers; for example, this can be a silicone support surface. When executing the welding lines in a sequence, it is preferable to first execute a completely external welding line 16, which surrounds the other welding lines to be produced, and to set welding parameters that ensure releasable adhesion of the film layer to the support surface. As a result, the film layer is releasably fastened to the support surface along this circumferential welding line, thereby preventing undesired wrinkling or undesired displacement of the film layer on the support surface or of the films relative to one another.

[0071] After all predetermined welding lines along which the two films of a respective film layer are to be welded together have been executed, the two film layers 10, 20 are placed on top of one another, as shown in Figure 1c. In this superimposed state, as shown in Figure 1d, further predetermined welding lines 31 are executed, which connect the films of the two film layers to one another.

[0072] Once all of the predetermined welding lines that connect all four films to one another have been created, the surgical tent structure produced in this way is separated from the film layers using a cutting device, see Figures 1 e and 1 f. The cutting device can be designed as a movable knife that follows a corresponding contour line around the welded film layers from which the surgical tent is formed. The surgical tent can then be removed, see Figure 1f, and is now in a flat, pliable manufacturing state A. In this manufacturing configuration, it typically has a dimension in the longitudinal direction LF (corresponding to the unwinding direction of the film layer) of less than 2 meters, in particular less than 1.75 or 1.5 m, and can also have dimensions of less than 1 m in this longitudinal direction for small surgical procedures.In the transverse direction (QF), the dimensions are typically similar to these longitudinal dimensions. The thickness (DF) of the superimposed, welded film layers—possibly with a welded-in viewing window and a frame construction for application to the patient's skin surface—is less than one centimeter or a few centimeters in the manufacturing configuration and is usually less than 10 cm, especially less than 5 cm.

[0073] From this production configuration, it can be folded once or several times into a compact transport position - see Figure 1 g1) - and can thus be easily transported and stored without taking up much storage space. In this transport configuration, it typically has a dimension in the longitudinal direction LT and transverse direction QT of less than half the corresponding dimensions LF, QF, in particular less than a third or a quarter. The thickness DT of the superimposed, welded film layers in the transport configuration is greater than the thickness DF in the production configuration; depending on the number of folds, this can be double, triple, or quadruple, or a larger multiple, of the thickness in the production configuration.

[0074] By filling the stabilizing elements 15, 25 produced during welding with air, these tubular structures, which can extend along the side surfaces, end surfaces, and / or the upper side of the surgical tent, are stiffened, and the surgical tent is thereby erected into a surgical configuration shown in Figure 1 h). This separates the two superimposed film layers from each other, creating a surgical space inside the surgical tent that is shielded from the environment by the film layers. To allow the inflow of air into this surgical space during the erection of the surgical tent (and also during subsequent intended ventilation after the surgical tent has been compressed), one or more openings equipped with sterile filters are formed on the surgical tent.Sterile air from the environment can be drawn into the interior of the surgical tent through these openings when it is erected by stiffening the stabilizing elements.

[0075] Figure 1h shows the surgical tent in the surgical configuration in a top view (left), a front view (top right), and a side view (bottom right). In this surgical configuration, the surgical tent has larger dimensions than in the transport configuration. Typically, the length LC is more than 0.5 m and less than 2 m, the height HC is more than 0.5 m and less than 1.5 m, and the transverse length QC is more than 0.25 m and less than 1 m.

[0076] The surgical tent has two viewing windows 13, 14, which are arranged at a slight angle at the top and allow a good view into the surgical room inside the surgical tent. If necessary, another viewing window or a coupling device for diagnostic optics or radiotherapy equipment can be provided at a central location 17. Two sleeves 41a, 42a are formed on each of the two side walls 40a, b, into which a user can insert their arms, thus gaining access to the surgical room for performing an operation.

[0077] Figure 2a shows an upper film layer 110 and a lower film layer 120 prior to their connection. A stabilizing element 115 is formed in the upper film layer 110 by welding along an inner, circumferential line 111 and an outer line 112 surrounding the inner line. This stabilizing element consists of an approximately square or rectangular ring element with four laterally projecting legs 115 ad.

[0078] The lower film section 120 is accordingly provided with four film sections protruding on the long sides, so that when the two film layers 110, 120 are placed on top of one another, the four leg sections come to rest on these protruding sections of the lower film section 120 and can be connected to one another on the outside, as shown in a cross-sectional view at the top of Figure 2b. These lateral leg sections can then be folded over by 180° in a further manufacturing step and then fixed in this folded position at their inwardly folded outer end by gluing at an adhesive point 128, as shown in the middle and bottom of Figure 2b. In this process, an outward-facing lower surface section 128a of the lower film layer 120 is glued to an inward-facing lower surface section 128b of the lower film layer. The two film sections thus assume the shape shown in Figure 2c.

[0079] If the stabilizing element 115 is now filled with a fluid and thereby stiffened, the surgical tent erects and assumes the surgical configuration shown in Figure 2d on the right and Figure 2e. The 180° fold of the stabilizing element opens partially, in the example shown by approximately 90°, and on the one hand an upright support leg 115a is created, and on the other hand the lower film layer 120 is stretched and thus brought into a largely wrinkle-free position in the erected state of the surgical tent. The gluing 128 and folding also create a pocket 129 in the interior of the surgical tent, which can serve as storage space. Figure 2e shows the arrangement with approximately vertically positioned support legs 115a, d and sleeve openings 141a, b at the corners.

[0080] Figure 2f shows the arrangement with approximately vertically positioned support legs 115a, d and pocket in a cross-sectional view (left) and a longitudinal section view (right). In this figure and in subsequent sectional views, the unfilled area "A" denotes a film, the uniformly lighter filling "B" denotes an air-inflatable stabilizing element, and the uniformly darker filling "C" denotes a cut surface.

[0081] Figure 3a shows an upper film layer 210 and a lower film layer 220 prior to their connection. In the upper film layer 210, a stabilizing element is formed by welding along an inner, circumferential line and an outer line surrounding the inner line, corresponding to the film layer 110 of Figure 2a. This stabilizing element consists of an approximately square or rectangular ring element with four laterally projecting legs.

[0082] The lower film section 220, like the lower film section 120 of Figure 2a), is provided with four film sections protruding on the long sides, so that when the two film layers 210, 220 are placed on top of one another, the four leg sections come to rest on these protruding sections of the lower film section 220 and can be connected to one another externally at the outer circumference 280, for example by welding, as shown in a cross-sectional view at the top of Figure 3b. In contrast to the embodiment of Figures 2a) to f), in the embodiment of Figures 3a) - g), the leg section is folded inwards instead of simply folding over by 180°.Figure 3c shows in perspective the process from Figure 3b, how the erecting support leg 215 and the protruding outer film section of the lower film layer 220, which is already connected to it at the outer circumference 280, are simultaneously turned inwards until the two assume a position folded 180° inwards to the starting position... This process and the associated effects are also described below with reference to Figures 3a-g.

[0083] If the stabilizing element 215 is now filled with a fluid and thereby stiffened, the surgical tent erects and assumes the surgical configuration shown in Figure 2d (right) and Figures 2e and 2f. The 180° fold and the resulting invagination of the stabilizing element opens partially, in the example shown by approximately 90°, creating upright support legs 215a on the one hand, and tensioning the lower film layer 220 on the other. The lower film layer 220 lies on the outside in the area of ​​the support legs 215a-d and thus forms four external pockets 290, which are formed by a lateral connection of the pockets between the upper and lower film layers. The vertically positioned support legs are inserted into these pockets 290 and thus come into contact with the other side of the lower film layer. This additionally tensions the second film layer and strengthens the position and stability of the support legs.In principle, this inversion of the support legs can also take place in the state with fluid-filled support legs if it has not already taken place in the non-fluid-filled state, since the displaceability of the fluid and the elastic deformability allow the support legs to be inverted from the then outer position to an inner position.

[0084] Figure 4a shows a third embodiment of an upper film layer 310 and a lower film layer 320. In this embodiment, both film layers have a stabilizing element 315, 325 which is formed by welding along an inner circumferential line and an outer circumferential line, each with four lateral leg sections 315a, b, 325a, b, geometrically similar to the previously explained embodiment of the upper film layer 110 according to Figure 2a. The four leg sections 325a-d of the lower film layer 320 extend further than the four leg sections 315a-d of the upper film layer, and the upper film layer accordingly has four laterally projecting film layer sections 316a-d which are not designed as a stabilizing element.

[0085] Figure 4b shows the upper film layer 310 and the lower film layer 320 in a superimposed position. A longitudinal section of the leg section 315b of the stabilizing element 315 of the upper film layer is shown, as is a longitudinal section of the leg section 325b of the stabilizing element 325 of the lower film layer, and a film section 316b of the upper film layer that is not designed as a stabilizing element. The upper film layer and the lower film layer are then connected to one another along their outer periphery 317, with the connection being left out in the area of ​​sleeve openings 320, thereby creating access between the lower and upper film layers, i.e., into the surgical space, as shown in Figure 4c. In this first position, the leg section 325b rests on the downward-facing surface 316b1 of the film section 316b. As shown in Fig.As can be seen in Figure 4b), this leg section 325b is then folded inwards and, after this folding, rests against the previously upward-facing surface 316b2 of the film section 316b. By this folding and the resulting relocation of the leg section from resting on the surface 316b1 to resting on the surface 316b2 of the film section 316b, the stability of the surgical tent in the expanded position, as shown in Figures 4e) to g), is considerably increased. By means of a connection, in particular welding, laterally next to the film section 316b, additional reinforcement and effective lateral stabilization can be achieved, and the support leg can be arranged in a partially or three-sidedly enclosed pocket formed by the film section 316b and this lateral connection.

[0086] By inflating the stabilizing elements with a fluid such as air, they are transformed from the pliable configuration shown in Figure 4d into a stiffened configuration, and the surgical tent is thereby erected into the surgical configuration, as shown in Figure 4f. The outwardly projecting leg sections 315b, 325b overlap, as can be seen on the right in Figure 4e and in perspective in Figure 4g, and are connected and held in this position by the outer film section 316b of the upper film layer, which is not designed as a stabilizing element. The longer leg section of the lower film length 220 lies inward to the shorter leg section of the upper film layer 210. Figure 4f shows the resulting three-dimensional geometry of the surgical tent.

[0087] It should be understood that the folding process of the not yet filled stabilizing element, as shown in Fig. 4b), can also be omitted and the surgical tent can also be erected from the position of the leg section 325b against the surface 316b1 shown above in Fig. 4b). In this case, the leg section 325b and the film section 316b would then lie on the outside of the leg section 315b. From the leg sections 315a-d, 325a-d arranged in this orientation, an improved stability of the surgical tent can be achieved by turning the leg sections 325a-d formed on the lower film layer 320 over onto the inner side of the leg sections 315a-d formed on the upper film layer, and the leg section 325b can be moved from the position against the surface 316b1 to the position against the surface 316b2. For this purpose, you can take advantage of the elasticity of the leg sections and the foil section.

[0088] In principle, it should be understood that the stabilizing elements, as shown, can be designed as essentially tubular structures with connection and intersection points, formed by welding two film layers along two parallel lines. However, other advantageous shapes of the stabilizing elements can also be implemented, for example, narrowed sections as predetermined bending points, widened sections as particularly stable areas, double-strut-like configurations divided by a central weld, or T-shaped widenings, which, for example, achieve broader support and load transfer in the contact area of ​​a stabilizing element on a base, on the patient's body, or the like.

[0089] Figure 5a schematically shows the structure of a stabilizing element 415, which can be arranged, for example, around a viewing window 413 or around a sleeve connection opening of a film layer. As shown, the stabilizing element 415 can form a self-contained ring structure with a trapezoidal contour and can be connected to further stabilizing element sections 415a, b at the corners or long sides.

[0090] The stabilizing element 415 has a region 415c with a tapered cross-section, where it can be bent more easily when the surgical tent is erected by inflating the stabilizing element with a fluid than in the other regions of the stabilizing element with a larger cross-section. Such a tapered region 415c of the stabilizing element can be formed between two legs or at a connection point of three legs of the stabilizing element, as shown in Figures 5b and 5c. In this way, the surgical tent can be erected into a stable and predetermined three-dimensional shape using predefined bending points of the stabilizing elements. Figures 5d and 5e show, circled, corresponding predefined bending points 415d,e,f, which can be defined by such a tapering of a stabilizing element.Figures 6a-f illustrate the fluid-tight attachment of a viewing window 613 in the region of a section of a film layer 610 made of EVA film(s). A first embodiment is shown in Figures 6a-c and a second embodiment in Figures 6d-f.

[0091] As can be seen, the film layer 610 has a trapezoidal cutout 611, which is closed by the viewing window. The viewing window 613 is formed from a PET film and is also cut into a trapezoidal shape, with the dimensions of the trapezoidal PET window 613 being larger than the dimensions of the trapezoidal cutout in the EVA film layer.

[0092] In a first embodiment, the PET window is bonded to the EVA film layer using an adhesive tape 630, which is bonded to the edge of the PET window. For this purpose, the adhesive tape 630 is cut to a trapezoidal shape and is preferably double-sided adhesive in order to form a strong bond both to the PET window and, after removal of a lamination 631, to the EVA film layer 610.

[0093] Figure 6b shows the subsequent manufacturing step. As can be seen, the PET window 613 is bonded to the EVA film layer 610 using the adhesive tape 630, thereby securing it in position. Subsequently, the connection is welded to a sufficient strength to ensure load-bearing capacity and a secure seal along the entire circumference.

[0094] In a second embodiment, as shown in Figures 6 df, in a first step, shown in Figure 6d, the PET window, which in this production variant is located above the first film layer, is laminated on the back with an additional film layer of EVA 631 by means of an adhesive tape 630, which is glued to the edge of the PET window. For this purpose, the adhesive tape 630 is cut to a trapezoidal outline and is preferably double-sided adhesive in order to form a strong adhesive effect both on the PET window and on the EVA film lamination 631, which is cut to identical dimensions to the adhesive tape.

[0095] Figure 6e shows the subsequent manufacturing step. As can be seen, the PET window 613 is bonded to the EVA film lamination 631 using the adhesive tape 630 and can be easily aligned in its target position thanks to the sliding EVA edge on the back of the lamination. Subsequently, the connection is brought to a sufficient bond strength of all layers by welding the EVA layers and activating the adhesive layers in order to create a load-bearing capacity and secure seal along the entire circumference.

[0096] For this purpose, a welding head 650 with a glass sphere 651 mounted so that it can rotate on all sides is moved along the outline of the PET window, and a laser beam from a laser source is coupled via a collimator line 652 through the glass sphere into the EVA film 610, the EVA lamination 631, the adhesive tape 630, and the viewing window 613 in order to effect thermal welding and activation of the adhesive layer. Due to the free mounting of the sphere, the welding head can be rolled over the PET window and the film arrangement below it and can thus be moved along the trapezoidal connecting line. This creates a weld 655 between the EVA film, the adhesive tape, and the PET window along the entire circumference. The connection of the PET window in the cutout of the EVA film, created in this way and gas-tight, by means of a welding line 655, is shown in Figure 6c.

[0097] Figures 7a-d show a schematic, sectional front view of the surgical tent in the expanded surgical configuration. Stabilizing elements 713 transform the surgical tent into a stable structure with an approximately trapezoidal cross-section. A sleeve section 720 is arranged on a side wall 712 and extends from an entrance opening 721 to a hand section 722. The hand section 722 has a glove 723 firmly connected to the sleeve section and detachably connected to the sleeve section 720 via a cuff 724. A user can thus push their arm through the entrance opening 721 and insert their hand through the sleeve section 722 into the glove 723. This allows the user to perform appropriate treatment procedures with their hand within the surgical chamber 701 of the surgical tent without the risk of introducing germs into the surgical chamber 701.

[0098] Above the sleeve entrance opening 721, a further sleeve section 730 is arranged on the surgical tent. This further sleeve section 730 is formed by a corresponding sleeve-shaped protrusion of the film layer toward the outside of the surgical space. This second sleeve section 730 is arranged adjacent to the first sleeve section 720 such that the first sleeve section 720 can be inserted into the second sleeve section 730.

[0099] The second sleeve section 730 extends from a sleeve entry opening 731 to a hand section 732. The sleeve entry opening 731, in this case, is an opening that allows access to the second sleeve section 730 from the surgical room. A user can thereby insert their hand, which has been inserted into the first sleeve section, into the second sleeve section 730 by gently pulling it back (see Figure 7b) and pointing it upwards. The hand remains within the first sleeve section, and the first sleeve section 720, together with the glove 723, is inserted into the second sleeve section (see Figure 7c).

[0100] This embodiment can, as can be seen from Figure 7d, be designed for two separate sleeve sections 720a, b, each having a corresponding second sleeve section 730a, b above it. A user can thus conveniently operate a device to be operated outside the surgical tent, for example an irradiation device, an optical observation device, or the like, by pushing their hand into the second sleeve section 730 or both their hands together with the first sleeve section 720 or 720a, b into the two second sleeve sections 730a, b. In this way, they can operate such devices outside the surgical room without the risk of contaminating the surgical room, for example by adjusting a focus, aligning, or pressing a button or the like.

[0101] Figures 8a-d show a second embodiment of such a sleeve arrangement. In this second embodiment, a first sleeve section 820 is also formed, extending from a sleeve entry opening 821 to a hand section 822. The sleeve entry opening 821 is formed at a lateral outward extension 825 of the film layers 810, 820, so that the sleeve section extends through this lateral outward extension 825 into the surgical space 801.

[0102] The lateral outward extension 825 has a second sleeve section 830 at its upper end, which in turn extends from a sleeve entry opening 831 to a hand section 832. This second sleeve section 830 can in turn be reached by retracting the hand and directing the hand upwards by the hand inserted into the first sleeve section 820, thereby inserting the hand together with the first sleeve section 820 into the second sleeve section until the first hand section 822 reaches the second hand section 832. Consequently, in this embodiment, too, a device or instrument arranged outside the surgical room 801 can be reached and operated by hand, as can be seen in Figure 8c.In the same way as in the previously explained first embodiment, it can also be provided in this embodiment that two first sleeve sections 820a, b are provided on the surgical tent and are each connected at a corresponding protuberance to a respective second sleeve section outside the surgical room in such a way that a hand together with the first sleeve section can be inserted into the corresponding second sleeve section, as can be seen from Figure 8d.

[0103] Figures 9a and b show a double valve of a surgical tent according to the invention. The double valve is provided for filling two separate stabilizing elements. It should be understood that the entire surgical tent can be shaped into the desired form by a single stabilizing element, which can have multiple branches, leg sections, loops, and the like. The single stabilizing element can be filled with fluid through a single valve. The single stabilizing element can also extend across the lower and upper film layers by connecting stabilizing elements formed therein to one another in such a way that fluid can pass from a section of the stabilizing element in the lower film layer to a section of the stabilizing element in the upper film layer.

[0104] However, it is preferred that the surgical tent be shaped and held in the desired position by two or more separate stabilizing elements. These separate stabilizing elements can be adjacent to one another or run side by side, but are characterized by the fact that they each have a closed cavity and are filled through their own valve. Erecting and stabilizing the surgical tent with multiple stabilizing elements has the advantage that if a single stabilizing element fails, for example, due to a leak, the surgical tent can still be held in shape by the other or additional stabilizing elements.

[0105] The double valve depicted in Figures 9a and b makes it possible to fill a stabilizing element 515 of the upper film layer and a stabilizing element of the lower film layer from a superimposed section of an upper film layer 510 and a lower film layer 520. The upper film layer has two films 511, 512, and the lower film layer has two 521, 522. These are widened in one end region and dimensioned such that the uppermost film 511 and the lowermost film 522 extend less far than the intermediate films 512 and 521. The four films are welded together along their side lines 580, 581 and are thus sealed.This welding essentially creates three loop-shaped cavities, which are formed between the uppermost film 511 and the second film 512, between the second film 512 and the third film 521, and between the third film 521 and the lowermost film 522. The second film 512 and the third film 521 are also welded to one another at their ends along a line 582, thereby closing off the unwanted access area into the interior of the surgical tent that would otherwise be formed by this end. The end faces of the two uppermost films 511, 512 and the two lower films 521, 522, however, are not welded to one another and thus form an opening that can be conveniently used with an insert piece of a pumping device.As a result, a mouthpiece can be pushed into the stabilizing element 515, which is formed by the two upper films 511, 512, in order to fill the stabilizing element 515 of the upper film layer 510 and, subsequently, the mouthpiece can be pushed into the opening 591 of the stabilizing element 525 of the lower film layer 520 between the third film 521 and the lower film 522 in order to fill the stabilizing element 525 of the lower film layer 520.

[0106] Figures 10a and b show a second embodiment of a double valve according to the invention for a surgical tent. In this second embodiment, as in the first embodiment of Figures 9a and b, the double valve is formed by four film layers 911, 912, 921, 922, which are welded together along their entire outer contour to form a total of three tubular cavities. In contrast to the first embodiment, all four film layers 911-922 extend the same distance in the manner of a leg-shaped elongated section. A circular cutout 990 in the uppermost film layer 911 and a similarly designed circular cutout 991 in the lowermost film layer 922 enable access of a mouthpiece to the stabilizing element 915 formed between the uppermost film layer 911 and the second film layer 912.Similarly, the mouthpiece can be inserted through the opening arranged in the lowermost film layer 922 into the stabilizing element 925 formed between the third film layer 921 and the lowermost film layer 922, and this stabilizing element can be filled with fluid accordingly. Figure 10b shows this structure in a partially sectioned view in the lower part of the figure.

[0107] Figures 11 a and b schematically show a production sequence analogous to Figures 1 c and d for the manufacture of a surgical tent with an attached hose arrangement for disinfecting an extremity before its introduction into the surgical room. As already explained above, the surgical tent is brought into a production configuration, and a layer comprising a total of four films is produced from two film layers 1010, 1020, each comprising two films, after the two film layers have each been welded along predetermined lines and cut to size if necessary. The two superimposed film layers are then, in Figure 11 b, also subjected to such welding along predetermined lines, whereby the two film layers are connected to one another in a gas-tight manner and enclose a surgical room 1000.In contrast to the manufacturing sequence shown in Figure 1, an elongated tube 1070 is included on one end of the surgical tent. This tube 1070 is formed by welding the two film layers along two edge lines 1071, 1072.

[0108] Figure 11c shows the embodiment of this surgical tent in the surgical configuration. As can be seen, the extremity disinfection hose 1070 extends from one end of the surgical room to a specifically designed end section 1073, explained below.

[0109] Figure 11d shows the basic structure of the extremity disinfection tube made from the cut sections of the four film layers 1070a-d. The two upper films 1070a, b are made from the upper film layer 1010, and the two lower film sections 1070c, d are made from the lower film layer 1020. A tubular interior space is formed between the two upper films 1070a, b, which is sealed along the edges by welding on all sides and is accessible through an arm entry opening 1074. An arm can be inserted through this arm entry opening 1074 into this tubular interior space and disinfected therein. This disinfection can be achieved by rubbing a disinfectant already present in the interior space onto the arm and allowing it to act on it, or by filling such an agent after inserting the arm via the valve opening 1078 provided separately for this purpose (see Figure 11e).After the arm has been disinfected, it can be inserted from the interior space between the films 1070a, b by piercing a pre-perforated opening 1075 into the space between the films 1070b, c, and from this space, which is connected to the interior of the surgical tent, it can be advanced into the interior space. The extremity disinfection tube is gathered accordingly to allow the arm to be advanced.

[0110] In the same way, on the underside of the extremity disinfection tube, a leg can be pushed through a correspondingly larger opening 1076 into the interior space between the lower film 1070c and the lowest film 1070d, disinfected therein, and finally pushed through a pre-perforated opening 1077 in the film 1070c into the space between the two middle films 1070b, c, and from there pushed into the interior of the surgical tent. Both the disinfection actions and the advancing of the arm or leg can be assisted from the outside, on the one hand, and can also be carried out from the surgical room by reaching into the space between the films 1070b, c, on the other.

[0111] Figure 11f shows this basic structure in an expanded view. Figures 11g and 11h show the process of advancing an arm from the extremity disinfection tube 1070 into the surgical room 1001.

[0112] Figure 12 shows the manufacturing method and functionality of a separately manufactured variant of an extremity tube. The extremity tube is again made from two double film layers, as symbolically depicted in Figure 12a, and formed from these two double film layers by welding and cutting. The uppermost film layer 1310 has a small extremity opening 1311, and the underlying second film layer 1320 has a correspondingly dimensioned slit 1321, the size of which is adapted to the opening 1311.

[0113] The bottom film layer 1340 has a larger extremity opening 1341, and in the third film layer 1330, a through-slot 1331 adapted to this extremity opening is positioned at the connection end facing the surgical tent. As can be seen from Figure 12d, the two extremity openings 1311 and 1341 are located at the insertion end of the extremity tube and serve to either insert a thin extremity, such as an arm, through the opening 1311 into the extremity tube or to insert a larger extremity, such as a leg, through the opening 1341.

[0114] The extremity tube accordingly has an upper encapsulated volume 1315, which is arranged between the first and second films 1310, 1320, and a second volume 1345 between the third and fourth films 1330, 1340, which are accessible through the first extremity opening 1311 and the second extremity opening 1341, respectively. Between these two volumes 1315 and 1345, a middle encapsulated volume 1325 is arranged between the second and third films 1320, 1330, which is accessible from the upper and lower volumes through the slots 1321 and 1331. As shown as an optional embodiment in Figure 12f, a superimposed arrangement of several, here three, film sections, each with round openings of different and staggered sizes formed therein, which are arranged above the opening of the extremity openings 1311 and1341 are welded to each other and to the disinfection tube at the edges, allowing for a more precise, germ-proof fit to limbs of varying thickness. With this principle, the appropriate opening is selected, and all openings smaller than this selected opening can either be used to closely fit the tapered geometry of the limb or can be cut or torn to facilitate passage of the limb.

[0115] The opening of the film located further out has a larger diameter than the opening 1311 or 1341 below it, and these stacked openings thus form several sealing lips against the extremity and enable an optimized and size-variable adaptation to the almost conical anatomy of the forearm and lower leg.

[0116] An injection section 1350 is arranged laterally on the extremity tube, which is also designed in four layers and through which it is possible to fill the upper volume 1315 or the lower volume 1345 with a disinfectant liquid using a syringe, as shown in Figure 12g, h. This allows an extremity inserted into one of these volumes to be disinfected and, after disinfection, can then be inserted sterilely through the slot 1321 or 1331 into the intermediate volume 1325 and from there pushed into the surgical tent, with the extremity tube being gathered accordingly to enable this advancement movement.

[0117] Figure 13 shows an embodiment of a cutting knife for guiding along curved paths across a film for cutting along straight lines and large and small radii on superimposed films for producing an expandable surgical tent. The cutting device comprises, on the one hand, a knife 1110, which is mounted on a knife shaft 1120 rotatably mounted about a vertical axis 1101 and can thus rotate about this axis 1101.

[0118] The knife shaft 1120 is in turn arranged in a bushing 1130 that is axially displaceable relative to the rotational axis 1101. The bushing 1130 is supported against a support head 1140 by a helical spring. By axial pressure on the bushing 1130, the cutting knife 1110 is moved out of an opening in this support head 1140 by a small amount. This amount is limited by a stop between the bushing 1130 and a housing shoulder on a housing 1150 and can be adjusted by inserting the knife 1110 into the knife shaft 1120.

[0119] The support head 1140 has a support surface at its lower end that is flattened in the center 1145 and spherically shaped at the edge 1140. The support surface is curved like a centrally flattened spherical segment. The cutting device can thus be guided over a film layer 1102 and make a curved cut 1103 therein without the risk of wrinkling or slipping of the films relative to one another.

[0120] Figures 14 a-c show, in a schematic cross-section, a stabilizing element with redundancy against cutting damage on both the inside and outside of the surgical tent. The stabilizing element is constructed from a four-layer film. An interior space 1201 is enclosed between an inner first film 1212 and a second film 1213, which is filled with fluid when the surgical tent is first erected in a surgical configuration and which effects the stabilizing effect. Arranged externally to and adjacent to the film 1212 is a further film 1211, which is connected to the film 1212 to form a fluid-tight interior space 1203. Arranged externally to and adjacent to the film 1213 is a further film 1214, which is connected to the film 1212 to form a fluid-tight interior space 1202.

[0121] The three separate interior spaces 1201, 1202 and 1203 can be filled with fluid by means of separate valves 1201', 1202' and 1203'.

[0122] If damage D occurs to the stabilizing element on the side facing the surgical room, starting from the situation shown in Figure 13a, this typically damages the film 1211 and 1212, and the interior space 1201 is therefore no longer fluid-tight. In this case, a redundant stabilizing element can be constructed by filling the interior space 1202 through the valve 1202'.

[0123] If damage E occurs to the stabilizing element on the side facing the surgical room, starting from the situation shown in Figure 13a, this typically results in damage to the film 1213 and 1214, and the interior space 1201 is therefore no longer fluid-tight. In this case, a redundant stabilizing element can be constructed by filling the interior space 1203 through the valve 1203'.

[0124] Figure 15 shows a glove ring that allows a glove to be attached to a sleeve and changed without penetrating the sterile barrier formed by the glove. The glove ring has a total of three circumferential annular grooves 1410, 1420, and 1440, with the two annular grooves 1410 and 1440 being arranged at each end, and the annular groove 1420 being arranged adjacent to the annular groove 1410. A cylindrical surface 1430 is arranged between the central annular groove 1420 and the peripheral annular groove 1440.

[0125] By means of this arrangement of three annular grooves, a sleeve 1450 and a glove 1460 placed over it can be fastened in the left and right edge annular grooves 1440 by slipping them one after the other over the ring and by means of rubber-elastic ring elements 1410a, 1440a, which engage around the sleeve lying on the glove ring and fix it in the annular grooves 1410 and 1440, as well as the rubber-elastic ring element 1420a which engages around the outside of the glove lying above and engages in the annular groove 1420 and locks the glove.

[0126] If the glove is now to be replaced by another glove, the rubber-elastic ring element 1420a can first be moved from the ring groove 1420 into the sleeve area outside the ring and the glove 1460 to be replaced can then first be pulled back into the interior of the ring and its elastic edge can be pushed or rolled onto the cylindrical surface 1430.

[0127] Starting from the right side, i.e., coming from the sterile area, a new glove 1470 can then be slipped over the ring, the cylindrical surface 1430, and over the elastic ring element 1410a located in the ring groove 1410. It can then be locked in the ring groove 1420 with the elastic ring element 1420a, which was rolled onto the sleeve. Once this has been done, the inwardly turned glove 1460 can be pulled off and removed through the sleeve. To facilitate this process, the central ring groove 1420 is shallower than the two peripheral ring grooves 1410, 1440, and the cylindrical surface 1430 is correspondingly wide and raised.

[0128] Figure 16 shows the schematic sequence of the manufacturing process for a surgical tent in an arrangement with two double film layers. In a first step, a first double film layer is formed by welding along predetermined lines such that these two films of the double film layer are connected to each other along the line, thereby forming closed areas between them (Figures 16a and b). Following this, a second double film layer, which also already has such welding lines in the same way, but which may run differently than in the first double film layer, is placed on the first double film layer (Figure 16c).Following this, a connection is again created by welding along predetermined lines, which in this case extends over all four superimposed films and thereby creates a connection and cavity formation between the two double film layers (Figure 16e, f).

[0129] Figure 17 shows another preferred configuration of a surgical tent with the possibility of sterile discharge of hose connections, electrical supply connections, and the like. For this purpose, the surgical tent has a receiving bag 1510 on one side, which can be arranged at the front or side. The receiving bag can be formed between two films or two double film layers. This receiving bag 1510 is connected to the interior of the surgical tent by a constriction 1520, and a cable or the like can be pushed through this constriction 1520 from the surgical room into the receiving bag 1510 (see Figure 17b).As soon as this has been done, a constriction 1520" of the foils can be made around the tube, cable or the like that has been pushed through in the area of ​​the constriction 1520, so that a seal to the surgical room is created here and then the receiving bag can be opened to the environment either by cutting it open or through a resealable opening 1530 provided thereon in order to then pull the cable located in the receiving bag out into the environment (see Figure 17c).

[0130] Figure 18 symbolically shows another preferred feature of a surgical tent in the form of a ventilation hose 1610. The ventilation hose 1610 allows air to be guided out of the surgical room at a high volume flow rate, for example, when smoke or steam has formed in the surgical room and obstructs visibility. The ventilation hose 1610 preferably has a one-way valve, thereby preventing air from entering the surgical room through the ventilation hose 1610.

[0131] Figures 19a-d show a preferred embodiment of a resealable opening with the option of connecting a hose to the surgical tent. As can be seen, for this purpose and to maintain the sterile barrier of the surgical tent, external, circumferential locking groove hook elements 1711 are arranged in three rows in an annular end section of a hose connection 1710 formed on the surgical tent. More or fewer rows can also be used here.

[0132] For this purpose, a connecting hose 1720 has corresponding, circumferential annular groove hooks 1721 on the inner end side and can thus be slipped over the hose 1710 and locked to it along the locking groove hook elements 1711. The surgical tent-side hose section 1210 also has similar or differently formed closure elements 1712 on the circumferential inner side, by which this hose section can be tightly closed. This allows for a connection to be initially achieved between the hose section 1720 to be connected via the locking of the annular groove hook elements 1721 and 1711, and subsequently for the closure state of the closure elements 1712 to be released, thereby connecting the internal volumes of the connected hose and the surgical chamber.

[0133] Figures 20a-l show another preferred configuration of a surgical tent according to the invention. This configuration serves to connect a sterile container to the interior of the surgical room in such a way that sterile removal of instruments or material from the sterile container into the surgical room is possible without contamination from the exterior of the sterile container.

[0134] For this purpose, the sterile container lock 1800 is connected to the surgical tent via a hose 1810, which is designed as a lock by means of a double closure 1811, 1812. The sterile container S can be inserted into a receiving space 1820 from an opposite hose connection 1830, which is also closed from the environment by means of a closure 1831.

[0135] In this receiving space 1820, the lid SD of the sterile container S can be lifted and inserted into a lid receiving section 1821 and then folded sideways (Figures 20d-g). A sealing lip, formed by a circumferential edge film layer 1824, is placed on the edge of the container and flush with the upper edge of the container (Figure 20h). The interior of the sterile container is thus accessible without the risk of contact contamination from the outer container S. Subsequently, by reaching into corresponding access pockets 1822, 1823 on the receiving space 1820, the sieve SS located in the sterile container and the instruments or materials arranged therein can be lifted out of the sterile container S and placed next to it in the receiving space 1820. This sterile sieve SS can then be pushed through the lock 1810 into the surgical room, thus remaining sterile and not causing any unsterility in the surgical room.

[0136] Figure 21 shows a further preferred configuration of a surgical tent according to the invention, which serves to equip an electric tool with a battery and thereby maintain the sterile atmosphere in the surgical room. For this purpose, a lock is formed at the surgical tent via a connecting hose 1910 with two spaced-apart seals 1911, 1912. This can be additionally configured, but can also be configured such that this lock corresponds to the configuration provided for inserting a sterile container, as previously explained with reference to Figure 20.

[0137] In this configuration, a connection section 1960, specifically formed by two foils or a double foil arrangement, is formed in the shape of a distorted L on a receiving section 1920, which may be identical to the receiving section 1820 or may be designed separately. This connection section 1960 allows an electrical device EG to be pushed out of the receiving section 1920 into this L-shaped connection section 1960, wherein this electrical device EG is pushed into the L-shaped connection section 1960 with the insertion end of the battery pack or accumulator pack first.

[0138] The battery compartment for the battery pack is opened while still in the L-shaped connection section 1960. The unsterile battery pack is inserted from the outside through an inverted tube section 1930, which has a fluid-tight opening at the end that can be penetrated by pre-perforation. The L-shaped connection section 1960 is rotated and brought directly closer to the battery compartment. The tube section 1930 is inserted into the upper area of ​​the battery compartment, allowing the battery to pierce the perforation with light pressure and be inserted directly into the battery compartment without touching sterile parts. After the tube section 1930 has been reclosed and turned out, the battery compartment can be closed, and the electrical device can be inserted into the surgical room (Figures 21 e, f).

Claims

Claims An expandable surgical tent for providing an enclosed, sterile Environment around a surgical site, comprising: a first film layer with a viewing window cutout, a viewing window, characterized in that the viewing window is bonded by means of a pressure-sensitive adhesive tape that is arranged between a region running along an edge of the viewing window and an edge region of the first film layer that surrounds the viewing window cutout and is materially connected by means of a weld seam running along the outline of the viewing window cutout, wherein the weld seam extends in cross-section over the viewing window, the pressure-sensitive adhesive tape, and the first film layer. Surgical tent according to claim 1, characterized in that the viewing window consists of a first material and the first film layer consists of a second material that has a lower melting temperature than the first material.Surgical tent according to claim 1 or 2, characterized in that the pressure-sensitive adhesive tape comprises a carrier material whose melting temperature lies between the melting temperature of the first and second materials. Surgical tent according to one of the preceding claims, characterized in that the viewing window has a greater wall thickness than the first film layer. Surgical tent according to one of the preceding claims. characterized in that the viewing window consists of PET or comprises PET and the first film layer consists of EVA or comprises EVA. Surgical tent according to one of the preceding claims, characterized in that the viewing window and the first film layer consist of uncolored plastic, in particular are transparent. Surgical tent according to one of the preceding claims, characterized by at least one stabilizing element which is formed by a connection of the first and a second film layer, which, through the connection, delimit an inner, closed cavity fillable with a fluid, wherein the surgical tent can be brought from a production configuration into an expanded surgical configuration, wherein In the production configuration, the stabilizing element is flexible and foldable and the surgical tent can be folded into a flat, transportable package with a packing volume, and In the expanded surgical configuration, the surgical tent encloses an operating room with a volume greater than the packaged volume, and the stabilizing element can be placed in a stiffer state than in the production configuration by filling the cavity, and the expanded surgical configuration stabilizes the tent in a pressure state in which the air pressure in the operating room inside the surgical tent and in the environment outside the surgical tent is consistent. A method for bonding two plastic film layers, comprising the steps: Arranging the two film layers in such a way that they overlap at least along a connecting line, Placing a contact element on the upper foil layer of the foil layers, Moving the contact element along the connecting line Introduction of thermal energy along the connecting line for welding the film layers, characterized in that the movement of the contact element takes place by rolling the contact element along the connecting line, and the introduction of the thermal energy takes place by passing an electromagnetic beam through the contact element. Method according to claim 8, characterized in that the contact element is a rotationally symmetrical body, in particular a sphere. Method according to claim 8 or 9, characterized in that the Contact element comprises a material that is transparent to light or consists of such a material. Method according to one of claims 8 to 10, characterized in that the electromagnetic beam is a laser beam. Method according to one of claims 8 to 11, characterized in that the Contact element is a glass sphere and the electromagnetic beam is a laser beam in the visible wavelength range. Method according to one of claims 8 to 12, characterized in that the Foil layers are supported on a support surface made of a plastic, and the plastic of the support surface has a higher melting temperature and / or lower absorption rate for the wavelength of the electromagnetic beam. Method according to claim 13, characterized in that the foil layers are welded along a first connecting line in a first step, and in a second step, they are welded along a second connecting line which is at least partially, preferably completely, enclosed by the first connecting line. 15.) Method according to claim 14, characterized in that in the first step the film layers are adhesively connected to the support surface along the first connecting line. 16.) Method according to one of claims 8 to 15, characterized in that the The film layers are glued together using a double-sided adhesive tape before welding, and the welding extends in cross-section through the first film, the adhesive tape and the second film. 17.) Device for welding two layers of plastic film, comprising: a contact element movable along a connecting line for placing on the film layers, an energy source for introducing thermal energy along the connecting line for welding the film layers, characterized in that the contact element is rotatably mounted in a bearing and is designed to be moved by rolling the contact element along the connecting line, and the energy source is a beam emitter of an electromagnetic beam, and the electromagnetic beam emitted from the beam emitter is directed onto the contact element and is guided by the contact element to the connecting line of the film layers. 18.) Device according to claim 17, characterized in that the contact element is a rotationally symmetrical body, in particular a sphere. 19.) Device according to claim 17 or 18, characterized in that the contact element comprises a material permeable to light or consists of such a material. 20.) Device according to one of claims 17 to 19, characterized in that the beam emitter is a laser beam source and the electromagnetic beam is a laser beam. 21.) Device according to one of claims 17 to 20, characterized in that the contact element is a glass sphere and the beam emitter is a laser beam source for emitting a laser beam in the visible wavelength range. 22.) Device according to one of claims 17 to 21, characterized by a support surface made of a plastic which has a higher melting temperature and / or lower absorption rate for the wavelength of the electromagnetic beam than the two film layers, and characterized in that the beam emitter is designed to emit the electromagnetic beam with such an energy density that the lower film layer is detachably and adhesively connected to the support surface in the region of the connecting line.

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