Surgery tent with double sleeve construction

Abstract

The invention relates to an expandable surgery tent for providing an enclosed, sterile environment around a surgical site, comprising: one or more film layers, which are compactly placed on top of one another in a transport configuration and take up a transport volume, and, in an expanded surgery configuration, enclose a surgery space and isolate it from the environment, the surgery space having an interior volume which is larger than the transport volume. The invention is characterised by at least a first sleeve portion which is fastened to a film layer and, in the surgery configuration, extends into the surgery space from a hand entry opening to a first hand portion and allows a user to reach their arm into the surgery space from outside the surgery tent, and a second sleeve portion which extends outside the surgery space to a second hand portion and which is connected to the first sleeve portion.

Description

[0001] Surgical tent with double sleeve construction

[0002] The invention relates to an expandable surgical tent for providing an enclosed, sterile environment around a surgical site, comprising: one or more film layers which, in a transport configuration, are compactly placed on top of one another and occupy a transport volume, and, in an expanded surgical configuration, enclose a surgical space and isolate it from the environment, which has an interior volume which is greater than the transport volume.

[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 surface barrier between non-sterile and sterile areas. These surface covers provide surface protection over a certain lateral extent, but do not demarcate adjacent airspace on all sides within the sterile area. These covers can therefore only function effectively in conjunction with air hygiene controls above the sterile areas, as well as the ambient air, and other comprehensive hygienic, structural, and organizational measures.

[0004] The requirements for sterile surgical, equipment, or instrument table drapes and 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.

[0005] Operating room / 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 an area of ​​a patient's body 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.

[0006] 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.

[0007] 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 in order to utilize the advantages of surgical tents, such as the small space required for storage when transported compactly and the ability to perform surgical procedures under sterile conditions in remote locations and 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.

[0008] 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. A second type of surgical tent is based on the principle of holding the walls of the surgical tent in an expanded state using stabilizing elements, thus allowing the surgical tent to be used in an operating state in which the pressure inside the surgical tent corresponds to the ambient pressure around the surgical tent. This design avoids the need to continuously supply a sterile gas with pressure monitoring of the interior 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 internal 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.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.

[0011] 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.

[0012] 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 wide variety of surgical procedures and applications, while providing good stability in the expanded form of the surgical tent. US 2016 / 0074268 A1 describes a surgical tent with two sleeve sections for inserting a user's right and left arm. These two sleeve sections each extend to form a hand section, but are not connected to each other, so it is not possible for the user to move their arm from the first sleeve section to the second sleeve section without pulling the arm out of the first sleeve section.Furthermore, this previously known surgical tent is provided with a lock, which, however, is not connected to either of the sleeve sections and also does not have a hand section, as this would also prevent the use of the lock.

[0013] DE 10 2007 049 362 A1 and DE 10 2013 007 205 A1 describe devices and methods for welding two films. These documents do not describe a method for manufacturing a surgical tent.

[0014] Surgical tents are generally suitable for performing minor procedures with a limited number of instruments. In this case, the instruments required for the treatment can be placed in the surgical room before the operation begins, or they can be brought in. In this case, the user can reach into the surgical tent with their arms after placing it on the patient's body or introducing a part of the patient into the surgical room, find the necessary instruments, and perform the operation.

[0015] For certain operations, it is necessary for the user to use instruments or aids that cannot be located inside the surgical suite but are located outside it. This may include, for example, an imaging device or optical device, such as a microscope or an X-ray machine, which must be used for diagnostic imaging during the operation.To achieve this, it is practical for this to be carried out by a second user who operates this equipment from outside the surgical room. This is because doing so by the operating user themselves often takes up too much time and poses a contamination risk. This is because they have to remove their hands from the surgical room, operate the equipment, and then return their hands to the surgical room in a sterile manner to continue the operation. However, using a second user is not only labor-intensive, but also often not efficient enough to perform an operation under optimal conditions and in a short time, for example when adjusting optical observation devices through which the operating user themselves monitors the surgical field. The object of the invention is to overcome these problems.

[0016] The invention solves the problem by developing the surgical tent explained at the outset by at least one first sleeve section which is attached to a film layer and which, in the surgical configuration, extends into the surgical room from a hand entry opening to a first hand section and allows a user to reach into the surgical room with his arm from outside the surgical tent, and a second sleeve section which extends outside the surgical room to a second hand section and which is connected to the first sleeve section.

[0017] The surgical tent according to the invention has a manufacturing configuration characterized in that this manufacturing configuration is created by connecting the first and second film layers and, if necessary, 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 connecting, folding, or cutting the two or more film layers. It should be understood that the surgical tent itself can 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, on the one hand, a first sleeve section is provided on the surgical tent, with which the user can reach into the surgical tent from the outside and perform the operation on the patient therein. Two separate sleeve sections of this type of first sleeve section can also be arranged on the surgical tent in order to enable the surgeon to reach in with both his left and right arm, and in addition, two or more further sleeve sections can be provided on the surgical tent in order to enable, for example, a second user to also reach into the surgical room with both arms. In addition to this first sleeve section or these multiple sleeve sections of the type of this first sleeve section, a second sleeve section is also provided on the surgical tent. This second sleeve section extends outside the surgical room.The second sleeve section is connected to the first sleeve section. According to the invention, this means that the second sleeve section is arranged adjacent to the first sleeve section in such a way that a user can reach this second sleeve section with their hand from the first sleeve section. This can be achieved, for example, by the user partially or completely withdrawing their hand from the first sleeve section and then inserting this hand into the second sleeve section, in order to then extend the hand thus inserted into the second sleeve section outside the surgical room and operate an instrument or device that is located outside the surgical room.This connection allows the user to operate the instrument or device with their hand via the second sleeve section without contaminating their hand, thus significantly reducing the handling effort and the time required for this operation. Alternatively, thanks to the connection between the first and second sleeve sections, the user can also insert their hand together with the first sleeve section into the second sleeve section and then operate the instrument or device via the second sleeve section without the hand or the first sleeve section becoming contaminated. According to the invention, the second sleeve section can, for example, be arranged in an area above the first sleeve section and have an opening which points towards the surgical room and enables the hand to be inserted out of the surgical room.This allows, for example, an instrument or device located above the surgical tent for imaging or observation to be easily operated via the second sleeve section.

[0023] The solution according to the invention prevents the hand from being removed from the first sleeve section and from being used to operate an instrument or device located outside the surgical room, thus preventing the associated contamination of the hand. The user can therefore move from the first sleeve section to the second sleeve section without great effort and in a short time, or can move from the first sleeve section into the second sleeve section in order to operate an instrument or device located outside the surgical room, thus reliably preventing contamination. The invention therefore makes it possible for a single user to efficiently perform operations requiring the use of such an external device / instrument.According to a first preferred embodiment, the first sleeve section has an inner sleeve surface open to the surroundings of the surgical tent and an outer sleeve surface open to the surgical room, and the second sleeve section has an inner sleeve surface open to the surgical room and an outer sleeve surface open to the surroundings of the surgical tent. According to this embodiment, the two interconnected sleeve sections have inverted extension directions, and the first sleeve section is open to the surroundings to allow a user standing in the surroundings to reach into this sleeve section with their arm and enter the surgical room to perform an operation on a patient's body that is accessible via the surgical room.The second sleeve section, however, is open to the surgical room and therefore allows the user to insert the hand into the second sleeve section from the surgical room and then perform a manipulation outside the surgical room in the vicinity of the surgical tent.

[0024] According to a further preferred embodiment, it is provided that the first and second sleeve sections form a V-configuration, in which the inlet opening is arranged at the base of the V-configuration, the two legs of the V-configuration are formed by the first and second hose sections, and the first and second hand sections are arranged at the ends of the two legs, or the first and second sleeve sections form a Y-configuration, in which the inlet opening is arranged at the base of the Y-configuration, the two legs of the Y-configuration are formed by the first and second hose sections, the first and second hand sections are arranged at the ends of the two legs, and the trunk of the Y-configuration is formed by a hose section that connects the first and second hose sections to the inlet opening.or the first sleeve portion is attached to one of the film layers and the second sleeve portion is attached to one of the film layers at such a location that the first sleeve portion can be inserted into the second sleeve portion such that the first hand portion reaches the second hand portion.,

[0025] According to these three alternative arrangements of the first and second sleeve sections, either a V-configuration of the two sleeve sections or a Y-configuration of the two sleeve sections enables the user to insert his arm with or without the first sleeve section into the second sleeve section, or an arrangement of the second sleeve section adjacent to the first sleeve section on the film layer enables the user to walk directly from the surgical room into the second sleeve section with his hand in the first sleeve section, so that the interior of the second sleeve section is part of the surgical room and is therefore correspondingly germ-free.In all three alternative configurations, it is achieved that the operation of a device or instrument located outside the surgical room can be carried out without contaminating the user's hand or the first section of the sleeve and can therefore be carried out in a time-saving manner.

[0026] It is further preferred if the second hand portion closes the second sleeve portion. According to this embodiment, the second sleeve portion is designed to be closed at the end, so that the user cannot extend their hand from the second sleeve portion. This closure function is particularly advantageous when the second sleeve portion is part of the surgical room and, consequently, with an open design of the second hand portion, the penetration of germs into the surgical room via the second sleeve portion must be prevented.

[0027] It is even further preferred if a first glove is attached to the first hand portion, or a first cuff is arranged for releasably attaching a first glove, and / or if a second glove is attached to the second hand portion, or a second cuff is arranged for releasably attaching a second glove. According to this embodiment, a glove can be attached to both the first and second hand portions, or can be releasably attached via a cuff. This allows the user to use the first or second sleeve portion, respectively, and to reliably avoid contamination from the skin surface of their hand by putting on a glove.

[0028] It is even further preferred if the first and second sleeve sections are arranged relative to one another such that a hand inserted into the first sleeve section can be inserted into the second sleeve section by retracting the hand from the first sleeve section to a transition point between the first and second sleeve sections and, starting from the transition point, pushing it forward into the second sleeve section, or by pushing the hand inserted into the first sleeve section together with the first sleeve section into the second sleeve section. This embodiment can be implemented in particular in conjunction with the three alternative configurations explained above: a V-shaped, Y-shaped, or separately arranged configuration of the two sleeve sections.By arranging the first and second sleeve sections in such a way that either a hand can be guided from a transition point from the first to the second sleeve section or a hand can be inserted into the second sleeve section together with the first sleeve section, time-saving and efficient operation is promoted and contamination of the surgical room due to such operation of an external device is reliably avoided.

[0029] According to a second aspect of the invention or a development of the invention, it is provided that the film layers comprise a first and a second film which, by being connected along two linear, spaced-apart first connecting regions, form a first stabilizing element which can be brought from a flexurally limp state into a flexurally stable state by filling a cavity formed between the connecting regions, and a third and a fourth film which, by being connected along two linear, spaced-apart second connecting regions, form a second stabilizing element which can be brought from a flexurally limp state into a flexurally stable state by filling a cavity formed between the connecting regions.This aspect of the invention and this development addresses a specific problem that arises with surgical tents when they are required to assume and maintain a stable three-dimensional structure without an internal pressure in the surgical room that is higher than the ambient pressure. In principle, this can be achieved by stabilizing elements formed between two films; however, there is a fundamental risk that leaks could cause such a stabilizing element to lose its internal pressure and thus its stabilizing effect to be lost. This is overcome according to this aspect of the invention by forming two stabilizing elements on the surgical tent, one formed between a first and second film and the other between a third and fourth film.This creates redundancy in that if one of the two stabilizing elements fails, the other stabilizing element can still function and exert a stabilizing effect on the surgical tent, thus preventing a complete loss of the stabilized three-dimensional shape of the surgical tent. The first to fourth films can be arranged one on top of the other in the surgical configuration, so that the two stabilizing elements are formed on a film layer comprising four films. However, the first and second films can also comprise a first film layer and the third and fourth films a second film layer, which do not lie on top of each other in the surgical configuration, but are connected to one another along separate connecting lines and thus jointly enclose the surgical space.In this case, the stabilizing effect is generated by the first and second stabilizing elements in spaced-apart areas of the surgical tent, for example on the left and right sides or on the bottom and top sides, so that at least partial preservation of the stabilization can be achieved with such a configuration if one of the two stabilizing elements were to be damaged.

[0030] This embodiment and this aspect of the invention can be further developed by a filling section in which the first, second, third and fourth films lie on top of one another and into which the first connecting regions and the second connecting regions extend, wherein a first filling opening which opens into the cavity of the first stabilizing element and a second filling opening which opens into the cavity of the second stabilizing element are arranged in the filling section and the second and third film layers are connected to one another in a fluid-tight manner in the region of the filling section. When preparing the surgical tent according to the invention for an operation, i.e. in particular when producing the surgical configuration from the transport configuration of the surgical tent, two or more stabilizing elements must be filled with a fluid and pressurized.It is desirable that this can be carried out in a short time and, if possible, without the risk of errors. To achieve this, the invention provides for a filling section in this development which is formed jointly by the first to fourth films. The four films lie on top of one another in the filling section in the numbered sequence, so that the first and fourth films enclose the second and third films between them. The cavity formed between the first and second films, which forms the first stabilizing element, opens into this filling section, as does the cavity formed between the third and fourth films, which forms the second stabilizing element. This cavity can be filled with fluid and pressurized through a first or second filling opening formed in the filling section.The second and third film layers are fluid-tightly connected to each other in the area of ​​the filling section, preventing the ingress of germs or fluid between the second and third film layers. This ensures that unwanted filling of the cavity between the second and third films or unwanted germ ingress between these two films cannot occur in the area of ​​the filling section, thus protecting a surgical space, which may be formed between the second and third films, from the surrounding germs.

[0031] It is even more preferred if the filling section is designed as the end section of a double hose, and the fluid-tight connection between the second and third film layers is formed at one end of the end section. Such a design as an end section makes the filling section easy to locate and easy to use, for example, connectable to a nozzle of a filling device, thus enabling both secure and rapid connection and filling of the two stabilizing elements.

[0032] It is even further preferred if the filling section is designed as the end section of a double hose and the second film layer extends at least partially further towards one end of the end section than the first film layer and / or the third film layer extends at least partially further towards the end of the end section than the fourth film layer. This further extension of the second and / or third film layer than the first or fourth film layer, on the one hand, facilitates the threading of a mouthpiece into the first or second filling opening, since the mouthpiece can be slid into the first or second filling opening on the second or third film layer.In addition, if both the second and the third film layer extend further than the first and fourth film layer, the sealing between the second and third film layer is simplified from a manufacturing point of view, since this can be achieved simply by welding or gluing these two film layers in the further extending end section of these two film layers.

[0033] According to a further preferred embodiment, the surgical tent can be further developed by a viewing window which is connected to one of the film layers and enables visual observation of a surgical procedure in the operating room from outside the surgical tent, wherein the second sleeve section extends over an area which lies outside the surgical tent and adjacent to the viewing window, wherein the viewing window is preferably glued by means of a pressure-sensitive adhesive tape which is arranged between a region running along an edge of the viewing window and an edge region of the first film layer running around the viewing window recess, and is materially connected 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 pressure-sensitive adhesive tape and the first film layer.

[0034] In the area of ​​the viewing window, the first film layer is provided with a viewing window recess, i.e., an opening created 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 higher-quality material 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 viewing window of the surgical tent having 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 is only folded with a radius so large 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 by means of a pressure-sensitive adhesive tape. Such a pressure-sensitive adhesive tape can in particular be a double-sided pressure-sensitive adhesive tape, i.e. formed by a strip that exerts an adhesive effect on both sides. By means of this pressure-sensitive adhesive tape, the viewing window is bonded along its edge to an edge area of ​​the viewing window recess.The pressure-sensitive adhesive tape is preferably bonded to the first film layer along the entire peripheral edge area of ​​the viewing window recess and correspondingly to the edge of the viewing window, thereby creating a seamless connection between the viewing window and the first film layer. This bonding ensures that the viewing window is bonded to the first film layer in a manner that is technically feasible, without creases or tension. The adhesive strength of the pressure-sensitive adhesive tape preferably allows an existing bond to be undone again in order to relieve any creases or tension 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 weld creates a highly resilient connection between the viewing window and the first film layer, incorporating the pressure-sensitive adhesive tape, so that no detrimental long-term leakage can occur due to the pressure-sensitive adhesive tape.Therefore, according to the invention, the pressure-sensitive adhesive tape does not need to exert the adhesive force required for the stable connection between the viewing window and the first film layer, but only the adhesive force required for precise, crease-free positioning and maintenance of this positioning during the welding process, which can in particular be lower than the bonding force generated between the viewing window and the first film layer by the welding. The inventive design of the connection between the viewing window and the first film layer reliably prevents potential tensions and displacements that could cause wrinkles to form between the viewing window and the first film layer during the welding process, since the pressure-sensitive adhesive tape maintains the positioning between the viewing window and the first film layer throughout the entire welding process.

[0035] It is even further preferred if the surgical tent can be brought from a production configuration into an expanded surgical configuration, wherein in the production configuration and the transport configuration, the stabilizing element is flexible and foldable and the first and second film layers can be folded together into a compact transport configuration with a packing volume, and in the expanded surgical configuration, the first and second film layers enclose a surgical 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, wherein preferably a section of the stabilizing element in the production configuration lies in a first position adjacent to a first side of a film section,and the portion of the stabilizing element can be displaced by elastic deformation of the first or second film layer or the film portion into another, second position in which it lies adjacent to another, second side of the film portion, so that the portion of the stabilizing element lies adjacent to the other, second side of the film portion in the expanded surgical configuration.

[0036] In this aspect of the surgical tent, the arrangement of at least one stabilizing element is such that, in the manufacturing configuration, it lies adjacent to a first side of a film section and can be displaced from this position adjacent to the first side by elastic deformation of the first or second film layer, or both film layers, or the film section into a second position in which the section of the stabilizing element lies adjacent to another, second side of the film section. The section of the stabilizing element can therefore be displaced from a first arrangement on the surgical tent to a second arrangement on the surgical tent by a folding or inversion process or the like.This offset can also be achieved, for example, by briefly relieving the stabilizing element of the inflation pressure within the stabilizing element in the area of ​​the section or adjacent thereto. This can cause it to be compressed or deformed, and thus moved into the second position, in which it can then be refilled with pressure and stiffen. This offset of the stabilizing element allows the stabilizing element to be reshaped from an initial configuration into a different configuration, thereby exerting a beneficial tensioning effect on one of the two film layers or both film layers.By relocating the stabilizing element, improved stability and tension of the surgical tent in the surgical configuration can be achieved compared to a surgical configuration that is erected by simply inflating the stabilizing element from the manufacturing configuration.

[0037] In principle, it is often advantageous and easier to handle to move the section of the stabilizing element when the surgical tent is already in the surgical configuration, i.e. the stabilizing element is filled. In principle, however, this process of moving the section of the stabilizing element can also be carried out in the production configuration or before the surgical configuration is created, by folding, turning inside out, or generally moving the stabilizing element from the first position towards the film section to the second position towards the film section with it resting on the other side. In this case, the surgical tent is only moved into the surgical configuration after such a move, by filling the stabilizing element.

[0038] The section of the stabilizing element that is displaced accordingly can be an end section, for example a leg section of the stabilizing element. It can also be a middle section, a loop, or a bow of the stabilizing element that is displaced accordingly, thereby creating the desired tension and stability. The elastic deformation of the first or second film layer can extend to film sections of this first or second film layer itself, or the stabilizing element itself, which is formed from the first and / or second film layer, can be deformed. Basically, it should be understood that the displacement of the stabilizing element from the first position to the second position occurs through a combined deformation of the film layers, including the stabilizing element and the film section. This deformation is an elastic deformation, i.e., the material of the film layers is elastically and thus reversibly deformed and no permanent plastic deformation of the material remains after the deformation has taken place.

[0039] This aspect of the invention provides a surgical tent that can be moved from a production configuration into a compact transport configuration and that can also be moved into a surgical configuration in which it assumes a particularly stable and structurally sound shape. The surgical tent is thus able to yield to movements of the user during the operation and to return to its original position after such a movement has been applied. In particular, according to the inventors' findings, it is possible for the user to deliberately compact the surgical tent from the expanded surgical configuration, thereby reducing the volume of the surgical room in order to expel any steam or smoke contained therein from the surgical tent.Thanks to the specific self-stabilized construction and tensioning of the stabilizing element by shifting it from the first to the second position, the surgical tent elastically and reliably returns to its original surgical configuration under its own power after such a deliberate deformation. The surgical room refills with sterile air through a corresponding suction effect, thus enabling clear visibility and the continuation of the operation.

[0040] According to a further aspect of the invention or a further development of the invention, the surgical tent can be further developed by a disinfection hose section which is connected to a film layer and encloses a disinfection interior which is filled or can be filled with a disinfection liquid and which is separated from the surgical room by means of a separable closure.

[0041] This aspect of the invention addresses a further specific problem of surgical tents, namely that in certain treatment situations it is desirable to perform an operation on an extremity, in particular a patient's arm or leg, within the surgical room. In this case, this extremity must be disinfected / sterilized before being introduced into the surgical room to prevent the introduction of germs into the surgical room via the extremity itself. This problem is solved according to this aspect of the invention and this development by an extremity tube that is closed off from the surgical room with a severable closure and that is or can be filled with a disinfectant liquid.The extremity tube can generally already contain a disinfectant liquid when delivered, so that it only needs to be opened, the extremity pushed inside and then disinfected. After disinfection, the closure is opened, which can be done in different ways. The closure can be opened, for example, by piercing a membrane with the extremity itself, or it can be done by the user, i.e. the surgeon, opening the closure from the surgical room, for example by making a cut or by manually tearing open a closure designed for this purpose. The extremity tube can be made from film in the same way as the surgical tent and, in particular, can be made from the film layers that form the surgical tent, using appropriate connections along lines.The separable closure can be made by a weak connection, for example a weak weld seam, or by a film section that can be severed with a cutting device from the surgical room.

[0042] The detachable closure or the film section can be formed, in particular, from a rubber-elastic material, thus enabling an opening to be created in this rubber-elastic material through which the extremity is advanced. The rubber-elastic material wraps around the extremity as a sealing sleeve, thereby creating a sealing effect between the extremity and this rubber sleeve. In this way, the surgical space in the area of ​​the connecting section to the disinfection tube section is sealed against the penetration of germs, even after the closure has been opened and the extremity has been inserted.

[0043] This aspect of the invention and this development can be further developed by having the disinfection hose section extend from the surgical room outward into the surroundings of the surgical tent, and by arranging the closure in the region of the connection between the disinfection hose section and the surgical room. According to this embodiment, the disinfection hose is attached to the surgical tent, and due to its arrangement, the closure can be easily reached from the surgical room and thus severed. This also allows the user, in particular, to pull the limb out of the disinfection hose section into the surgical room with their hand by means of a sleeve extending into the surgical room.It should be understood that the disinfection tube section can remain arranged around the limb during this movement of the limb and, for example, be gathered to allow the limb to be advanced into the surgical room. In other embodiments, the disinfection tube can also be removed by being severed during this advancement of the limb.

[0044] It is even further preferred if the disinfection tube section comprises a film that encloses the disinfection interior, and the closure is formed by a detachable connection of the film or by a separable puncture film connected to the film. According to this embodiment, in particular, an elastically deformable puncture film can be formed, through which the extremity is pushed after disinfection has taken place and which elastically seals against the extremity, thereby creating a germ-proof seal of the surgical space in the region of this opened closure. It is even further preferred if the surgical tent comprises a connecting section for detachably attaching the disinfection tube section, and the disinfection tube section is designed to be detachably attached to the connecting section, wherein the closure is preferably formed on the connecting section.It should be understood that the disinfection hose section can be permanently connected to the surgical tent, allowing the disinfection of the extremity to be carried out directly in the area of ​​the surgical tent before the extremity is inserted into the surgical room. In this preferred embodiment, however, the extremity can be inserted into the extremity hose at a different location, away from the surgical tent, and the disinfection process can be carried out. The connection between the disinfection hose section and the surgical tent is then established at a later time, and the extremity is then inserted into the surgical room. This form of training allows for more efficient working in many surgical procedures, as the preparation of the extremity and the performance of the operations can take place at separate locations.

[0045] It is further preferred if the disinfection hose section has a first disinfection space which is enclosed by a first and a second film and has a first access opening to the first disinfection space arranged in the first film at a first end section and further has an access space which is enclosed by the second and a third film and is connected or connectable to the surgical space, wherein the second film has a preferably pierceable first through-opening at a second end section of the disinfection hose section opposite the first end section, the size of which through-opening corresponds to the first access opening and which forms an access from the first disinfection space into the access space.This design, with a disinfection chamber and an access chamber formed by three films and separated from each other and the surroundings, enables efficient and safe disinfection of extremities outside the surgical room and easy insertion of the extremity into the surgical room after disinfection. The extremity is first pushed through the first access opening into the first disinfection chamber and disinfected therein using a disinfectant that is already stored therein or is poured into it. The extremity can then be guided through the first passage opening into the access chamber. The first passage opening can, in particular, be designed to elastically enclose the extremity and thereby seal it.The extremity can then be inserted from the access space into the surgical room, with the extremity tube being gathered to achieve the necessary mobility. It is even more preferred if the disinfection tube section has a second disinfection space which is enclosed by the third and a fourth film and has a second access opening in the fourth film arranged at the first end section to the first disinfection space, which is larger than the first access opening, wherein the third film has a preferably pierceable second through-opening at the second end section of the disinfection tube section, the size of which corresponds to the second access opening and which forms access from the second disinfection space into the access space. This configuration creates a total of two disinfection spaces, with the through-space lying between the two disinfection spaces.The second disinfection chamber is used in the same way as the first disinfection chamber, but its larger access opening accommodates a larger limb and therefore allows for insertion of the limb into the passageway. The limb tube designed in this way allows for greater variability in the size of the limb and can therefore, depending on the size of the first and second access openings—and correspondingly the first and second passage openings—be suitable for alternative disinfection of an arm or leg, or can be dimensioned to suit the disinfection of a child's or adult's arm.

[0046] A further aspect of the invention is a method for producing a surgical tent, in which the films are cut to size after being arranged on the support surface using a cutting device which has a curved contact surface, in particular a contact surface that is flat in the middle and spherically shaped at the edge, which is designed to transfer a pressing force between the contact surface and the support surface to the films and to be moved in a sliding manner over the films when the pressing force is exerted, wherein an opening is formed in the contact surface through which a cutting blade protrudes when the pressing force is exerted, which cutting the films during the sliding movement along the movement. This method according to the invention addresses a specific problem which arises in the production of surgical tents and which consists in the fact that an exact separation of two or more superimposed films is necessary for the production of the surgical tent.This precise separation is particularly problematic when several superimposed films have to be separated from one another and are not connected to one another immediately adjacent to the separation point, for example when the films form two or more different film layers. In this case, there is a risk of wrinkles forming when a knife is passed over these superimposed films. According to the inventors' findings, a precise separation that avoids wrinkles can be achieved using the method described above, in which a pressing force is generated by means of a curved contact surface. A curved contact surface is understood here to be a contact surface with a surface portion that is convexly curved in at least one direction, preferably a surface that is convexly curved in all directions at least at the edges, which can therefore be shaped like a flattened or uniform section of a spherical surface.The cutting blade protrudes through an opening in this contact surface, allowing it to perform its cutting action. The cutting blade can either protrude through this opening permanently or only pass through the opening when the contact force is applied, for example, if the contact surface is spring-mounted and moves back against a spring force when the contact force is applied, thereby allowing the cutting blade to pass through the opening.

[0047] It is particularly preferred if the cutting blade is pivotally mounted about a pivot axis running parallel to the direction of the contact force. Such a pivotable mount allows the cutting device to change direction during its sliding movement over the films without the need for complex pivoting of the entire cutting device. In this way, the alignment of the contact surface itself can be kept constant, while changes in direction still result in an exact cut thanks to the ability of the cutting blade to pivot about the pivot axis. This arrangement therefore enables precise cutting even with curved cutting lines. It is fundamentally important to understand that the pivot axis is preferably perpendicular to the sliding direction of movement of the contact surface over the films.

[0048] According to a further aspect of the invention or a development of the invention, it is further provided to develop the method with the steps of: placing a contact element on the upper film layer of the film layers, moving the contact element along the connecting line, introducing thermal energy along the connecting line to weld the film layers, wherein 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. By means of this embodiment, a precise and reliable welding of the films to one another is achieved, preferably before the cuts are made.In this case, a specific device arrangement is used which, on the one hand, generates a secure contact pressure of the films to be welded in the welding area by rolling a contact element onto the films, and, on the other hand, couples the energy required for welding into the films through this contact element and thus directly in or immediately adjacent to the contact pressure caused by the contact element.

[0049] It is preferably provided that the contact element is a rotationally symmetrical body, in particular a sphere, and the contact element preferably comprises a material that is transparent to light or consists of such a material, wherein further preferably the electromagnetic beam is a laser beam.

[0050] It is even further 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, wherein the film layers are welded in a first step along a first connecting line, and in a second step are welded along a second connecting line which is at least partially, preferably completely, enclosed by the first connecting line and the film layers are adhesively connected to the support surface along the first connecting line in the first step.

[0051] Preferred embodiments of the invention are explained with reference to the accompanying figures. They show:

[0052] Figure 1 ah: a schematic representation of the manufacturing steps for a surgical tent according to the invention,

[0053] 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,

[0054] Figure 3a-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 second embodiment,

[0055] 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,

[0056] Figure 5a-e: an embodiment of a support structure according to the invention with kinks for the surgical tent according to the invention, 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

[0057] 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

[0058] 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

[0059] 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,

[0060] 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

[0061] 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.

[0062] 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,

[0063] Figure 12 ah: a second embodiment of an extremity tube,

[0064] 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,

[0065] Figure 14a-c: A schematic, longitudinal section of a stabilizing element with redundancy against damage from both sides,

[0066] 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,

[0067] Fig. 16a-d is a schematic representation of the manufacturing sequence of a surgical tent according to the invention, Fig. 17a-c is a schematic representation of a conduit hose for sterilely leading a line out of the surgical room,

[0068] Fig. 18a,b a schematic representation of a surgical tent according to the invention with ventilation hose,

[0069] 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

[0070] Fig. 20a-l a schematic representation of a sterile container tube according to the invention.

[0071] Figure 21 a - f: A schematic representation of an integrated adapter for the introduction of batteries or rechargeable batteries in power tools, according to a second embodiment of a separate introduction bag for instrument containers to the surgical tent according to the invention

[0072] Figures 1 ah 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 1 a, 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 1 b. Both film layers 10, 20 are first connected to one another 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.

[0073] 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.

[0074] 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, further predetermined welding lines 31 are executed, as shown in Figure 1d, which connect the films of the two film layers to one another.

[0075] 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 1f. 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.

[0076] 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.

[0077] 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.

[0078] Figure 1h shows the surgical tent in the surgical configuration in a top view (left), a frontal 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. The surgical tent has two viewing windows 13, 14, which are arranged at a slight angle on the top and allow a good view into the surgical room inside the surgical tent. If necessary, a further viewing window or a coupling device for diagnostic optics or radiotherapy equipment can also be formed at a central location 17.On both side walls 40a, b, two sleeves 41a, 42a are formed into which a user can insert his arms and thereby gain access to the surgical room to perform an operation.

[0079] 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.

[0080] 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 case, 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.

[0081] The two film sections thus take on the shape shown in Figure 2c.

[0082] 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°, creating on the one hand an upright support leg 115a, and on the other hand the lower film layer 120 is stretched and thus brought into a largely wrinkle-free position when the surgical tent is erected. The adhesive bond 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. 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 representation “A” denotes a film, the uniform lighter filling “B” denotes an air-inflatable stabilizing element and the uniform darker filling “C” denotes a cut surface.

[0083] 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.

[0084] The lower film section 220, like the lower film section 120 of Figure 2a), is provided with four film sections protruding on the longitudinal 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 being folded 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.

[0085] 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, by approximately 90° in the example shown, 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] It should be understood in principle that the folding process of the not yet filled stabilizing element, as shown in Fig. 4b), can also be dispensed with, 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.

[0090] 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.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.

[0091] 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.

[0092] 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.

[0093] 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.

[0094] 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. 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. Following this, the connection is welded to a sufficient strength to ensure load-bearing capacity and a secure seal along the entire circumference.

[0095] 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.

[0096] 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.

[0097] 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.

[0098] 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.

[0099] 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.

[0100] 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).

[0101] This configuration 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, achieving alignment, or pressing a button or the like. Figures 8a-d show a second embodiment of such a sleeve arrangement.In this second embodiment, a first sleeve portion 820 is also formed, extending from a sleeve entry opening 821 to a hand portion 822. The sleeve entry opening 821 is formed at a lateral outward extension 825 of the film layers 810, 820, so that the sleeve portion 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 enables filling of 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, extended 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 a mouthpiece to enter 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 also welded along predetermined lines (Figure 11 b), 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 separately provided valve opening 1078 (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 disposed 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 disposed between the second and third films 1320, 1330, which is accessible from the upper and lower volumes through the slots 1321 and 1331.

[0115] As shown as an optional embodiment in Figure 12f, a more precise, germ-tight fit to extremities of different thicknesses is possible by arranging several, here three, film sections one above the other, each with round openings of different and staggered sizes, for example, which are welded to one another and to the disinfection tube above the opening of the extremity openings 1311 and 1341 in the edge region. With this principle, the appropriate opening is selected in each case, and all openings smaller than this selected opening can either be used to fit tightly against a tapered geometry of the extremity or can be cut or torn to facilitate the passage of the extremity.

[0116] 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.

[0117] 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.

[0118] 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.

[0119] 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.

[0120] 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.

[0121] 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.

[0122] The three separate interior spaces 1201, 1202 and 1203 can be filled with fluid by means of separate valves 1201', 1202' and 1203'.

[0123] 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'.

[0124] 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'.

[0125] 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.

[0126] Through this arrangement of three annular grooves, on the one hand, a sleeve 1450 and a glove 1460 pulled over it can be fastened in the left and right edge annular groove 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.

[0127] 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.

[0128] 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 less deep than the two peripheral ring grooves 1410, 1440, and the cylindrical surface 1430 is correspondingly wide and raised.

[0129] 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).

[0130] 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).

[0131] 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.

[0132] 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.

[0133] 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.

[0134] Figures 20a-l show a further preferred configuration of a surgical tent according to the invention. This configuration serves to connect a sterile container to 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. 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 pushed 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 peripheral 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.

[0136] Subsequently, by reaching into corresponding pockets 1822, 1823 on the receiving space 1820, the sieve SS lying 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 and thus remains sterile and does not cause any unsterility in the surgical room.

[0137] 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.

[0138] 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 facing forward. The battery compartment for the battery pack is opened while still in the L-shaped connection section 1960.The non-sterile 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 connecting 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 Expandable surgical tent for providing an enclosed, sterile environment around a surgical site, comprising: one or more film layers which o in a transport configuration are compactly placed on top of one another and occupy a transport volume, and o in an expanded surgical configuration enclose a surgical space and insulate it from the environment, which has an interior volume which is greater than the transport volume, characterized by at least one first sleeve section fastened to a film layer, which in the surgical configuration extends into the surgical space from a hand entrance opening to a first hand section and allows a user to reach into the surgical space with his arm from outside the surgical tent, and a second sleeve section which extends outside the surgical space to a second hand section and which is connected to the first sleeve section.Surgical tent according to claim 1, characterized in that the first sleeve section has an inner sleeve surface arranged open to the surroundings of the surgical tent and an outer sleeve surface arranged open to the surgical room, and. The second sleeve section has an inner sleeve surface arranged open to the surgical room and an outer sleeve surface arranged open to the surroundings of the surgical tent. Surgical tent according to claim 1 or 2, characterized in that the first and the second sleeve section form a V-configuration, in which the entrance opening is arranged at the base of the V-configuration, the two legs of the V-configuration are connected by the first and the second - M - tube section are formed and the first and second hand sections are arranged at the ends of the two legs, or the first and second sleeve sections form a Y-configuration, wherein the inlet opening is arranged at the base of the Y-configuration, the two legs of the Y-configuration are formed by the first and second tube sections, the first and second hand sections are arranged at the ends of the two legs and the root of the Y-configuration is formed by a tube section which connects the first and second tube sections to the inlet opening, or the first sleeve section is fastened to one of the film layers and the second sleeve section is fastened to one of the film layers at such a location that the first sleeve section can be inserted into the second sleeve section such that the first hand section reaches the second hand section. 4.) Surgical tent according to one of the preceding claims, characterized in that the second hand section closes the second sleeve section. 5.) Surgical tent according to one of the preceding claims, characterized in that a first glove is attached to the first hand portion or a first cuff is arranged for the releasable attachment of a first glove, and / or that a second glove is attached to the second hand portion or a second cuff is arranged for the releasable attachment of a second glove. 6.) Surgical tent according to one of the preceding claims, characterized in that the first and the second sleeve section are arranged relative to each other in such a way that a hand inserted into the first sleeve section can be inserted into the second sleeve section by The hand is withdrawn from the first sleeve section to a transition point between the first and second sleeve sections and is pushed forward from the transition point into the second sleeve section, or The hand inserted into the first sleeve section is pushed forward together with the first sleeve section into the second sleeve section. 7.) Surgical tent according to one of the preceding claims or the generic term of Claim 1, characterized in that the film layers comprise a first and a second film which, by being connected along two linear, spaced-apart first connecting regions, form a first stabilizing element which can be brought from a flexurally limp state into a flexurally stable state by filling a cavity formed between the connecting regions, and comprise a third and a fourth film which, by being connected along two linear, spaced-apart second connecting regions, form a second stabilizing element which can be brought from a flexurally limp state into a flexurally stable state by filling a cavity formed between the connecting regions. 8.) Surgical tent according to the preceding claim 7, characterized by a filling section in which the first, second, third and fourth films lie on top of one another and into which the first connecting regions and the second connecting regions extend, wherein in the filling section a first filling opening which opens into the cavity of the first stabilizing element and a second filling opening which opens into the cavity of the second stabilizing element are arranged and the second and third film layers are connected to one another in a fluid-tight manner in the region of the filling section. 9.) Surgical tent according to claim 8, characterized in that the filling section is designed as an end section of a double hose and the fluid-tight connection between the second and third film layers is formed at one end of the end section. Surgical tent according to claim 8 or 9, characterized in that the filling section is designed as an end section of a double tube and the second film layer extends at least partially further in the direction of an end of the end section than the first film layer and / or the third film layer extends at least partially further in the direction of the end of the end section than the fourth film layer.Surgical tent according to one of the preceding claims, characterized by a viewing window which is connected to one of the film layers and enables visual observation of a surgical procedure in the operating room from outside the surgical tent, wherein the second sleeve section extends over an area which lies outside the surgical tent and adjacent to the viewing window, wherein preferably the viewing window is glued by means of a pressure-sensitive adhesive tape which is arranged between a region running along an edge of the viewing window and an edge region of the first film layer running around the viewing window recess, and is materially connected 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 pressure-sensitive adhesive tape and the first film layer.Surgical tent according to one of the preceding claims, characterized in that the surgical tent can be brought from a manufacturing configuration into an expanded surgical configuration, wherein. In the production configuration and the transport configuration, the stabilising element is flexible and foldable and the first and second film layers can be folded together into a compact transport configuration with a packing volume, and In the expanded surgical configuration, the first and second film layers enclose a surgical space with a volume that is larger than the packed volume, and the stabilizing element can be placed into a stiffer state than in the manufacturing configuration by filling the cavity and stabilizes the expanded surgical configuration, wherein preferably a portion of the stabilizing element in the manufacturing configuration lies in a first position adjacent to a first side of a film portion, and the portion of the stabilizing element can be placed into another, second position in which it lies adjacent to another, second side of the film portion by elastic deformation of the first or second film layer or of the film portion, so that the portion of the stabilizing element in the expanded surgical configuration lies adjacent to the other, second side of the film portion. 13.) Surgical tent according to one of the preceding claims or the generic term of Claim 1, characterized by a disinfection hose section which is connected to a film layer and encloses a disinfection interior filled or fillable with a disinfection liquid, which is separated from the surgical space by means of a separable closure. 14.) Surgical tent according to claim 13, characterized in that the disinfection hose section extends from the surgical room outwards into the surroundings of the surgical tent and the closure is arranged in the region of the connection between the disinfection hose section and the surgical room. 15.) Surgical tent according to claim 13 or 14, characterized in that the disinfection tube section comprises a film which encloses the disinfection interior and the closure is formed by a detachable connection of the film or by a separable puncture film connected to the film. 16.) Surgical tent according to claim 13, 14 or 15, characterized in that the surgical tent comprises a connecting portion for releasably fastening the disinfection hose portion, and the disinfection hose portion is designed to be releasably fastened to the connecting portion, wherein preferably the closure is formed on the connecting portion. 17.) Surgical tent according to one of claims 13 to 16, characterized in that the disinfection tube section has a first disinfection space which is enclosed by a first and a second film and has in the first film a first access opening to the first disinfection space arranged at a first end section. has an access space which is enclosed by the second and a third film and is connected or connectable to the surgical space, wherein the second film has a preferably pierceable first through-opening at a second end section of the disinfection tube section opposite the first end section, the size of which through-opening corresponds to the first access opening and which forms an access from the first disinfection space into the access space. 18.) Surgical tent according to claim 17, characterized in that the disinfection tube section has a second disinfection space which is enclosed by the third and a fourth film and has a second access opening to the first disinfection space in the fourth film, which second access opening is arranged at the first end section and is larger than the first access opening, wherein the third film has a preferably pierceable second through-opening at the second end section of the disinfection tube section, the size of which corresponds to the second access opening and which forms an access from the second disinfection space into the access space. 19.) Method for producing a surgical tent, in particular a surgical tent according to one of the preceding claims, comprising the steps: Arranging two or more films on top of each other on a support surface to produce a first film layer, Joining the films of the first film layer along one or more predetermined lines to produce a production configuration of the surgical tent, from which the surgical tent can be folded into a compact transport configuration in which it occupies a packing volume, wherein at least two lines are arranged at a distance from one another and form a cavity that can be filled with fluid and can thereby be brought from a pliable state of the films thus joined to a stabilized state and then forms a stabilizing element for stabilizing the surgical tent in an expanded surgical configuration in which the surgical tent encloses a surgical room and shields it from the environment, wherein the surgical room has a volume that is larger than the packing volume, characterized in that the films are cut to size by means of a cutting device after being arranged on the support surface,which has a spherically shaped contact surface designed to transmit a contact force between the contact surface and the support surface to the foils and to be moved slidably over the foils under the exertion of the contact force, wherein an opening is formed in the contact surface through which a cutting blade protrudes when the contact force is exerted, cutting the foils during the sliding movement along the movement. Method according to claim 19, characterized in that the cutting blade is pivotally mounted about a pivot axis running parallel to the direction of the contact force. Method according to claim 19 or 20 or the preamble of claim 19, comprising the steps: 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 connection line to weld the film layers, wherein 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. 22.) Method according to claim 21, characterized in that the contact element is a rotationally symmetrical body, in particular a sphere, and the contact element preferably comprises a material which is transparent to light or consists of such a material, wherein further preferably the electromagnetic beam is a laser beam. 23.) Method according to one of claims 21-22, characterized in that 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, wherein the film layers are welded in a first step along a first connecting line, and in a second step are welded along a second connecting line which is at least partially, preferably completely enclosed by the first connecting line and the film layers are adhesively connected to the support surface along the first connecting line in the first step.

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