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WO2025056760A1 - Tente chirurgicale à élément de stabilisation déplaçable - Google Patents

Tente chirurgicale à élément de stabilisation déplaçable Download PDF

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Publication number
WO2025056760A1
WO2025056760A1 PCT/EP2024/075651 EP2024075651W WO2025056760A1 WO 2025056760 A1 WO2025056760 A1 WO 2025056760A1 EP 2024075651 W EP2024075651 W EP 2024075651W WO 2025056760 A1 WO2025056760 A1 WO 2025056760A1
Authority
WO
WIPO (PCT)
Prior art keywords
surgical
film
section
stabilizing element
tent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2024/075651
Other languages
German (de)
English (en)
Inventor
Michael Ahrens
Fyn WIBBERENZ
Justus KLINKFORTH
Alina BÖCKENFELD
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Surgitent GmbH
Original Assignee
Surgitent GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Surgitent GmbH filed Critical Surgitent GmbH
Publication of WO2025056760A1 publication Critical patent/WO2025056760A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/40—Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00—Surgical drapes
    • A61B46/20—Surgical drapes specially adapted for patients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00—Surgical drapes
    • A61B46/20—Surgical drapes specially adapted for patients
    • A61B46/27—Surgical drapes specially adapted for patients tubular, e.g. for arms or legs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00—Surgical drapes
    • A61B46/40—Drape material, e.g. laminates; Manufacture thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00535—Surgical instruments, devices or methods pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods pneumatically or hydraulically operated inflatable

Definitions

  • the invention relates to an expandable surgical tent for providing an enclosed, sterile environment around a surgical site, comprising a first film, a second film, and at least one stabilizing element which is formed by a connection of the first and second films, which, as a result of the connection, delimit an inner, closed cavity which can be filled with a fluid.
  • the surgical tent can be brought from a production configuration into an expanded surgical configuration.
  • the stabilizing element is flexible and foldable and the first and second films can be folded together to form a flat, transportable package with a packing volume.
  • the first and second films and optionally further films enclose a surgical space with a volume which is greater than the packing volume.
  • 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.
  • 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 have a Provide a barrier between non-sterile and sterile areas. These flat 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.
  • the surgeon or surgical assistant reaches into the surgical space enclosed by the surgical tent from outside with one or two hands to perform the operation.
  • the user therefore stands or sits outside the surgical tent in a non-sterile area.
  • a space in which the surgeon can work with his hands and which is immediately adjacent to the surgical site must be placed in sterile conditions and maintained in this sterile state throughout the surgical procedure, which corresponds to the conditions around the operating area in a surgical room.
  • Surgical tents in the narrower sense are generally collapsible into a compact form, allowing them to be transported and stored in a space-saving manner. This is crucial for the logistical processes in medical facilities, taking advantage of the advantages of surgical tents, such as the small space required for storage when transported compactly, the ability to perform surgical procedures under sterile conditions in remote locations, and the ability to easily transport the necessary equipment there. Even when surgical tents are used in hospitals for outpatient procedures, it is necessary to be able to store the surgical tents, which are regularly used as disposable products, in a space-saving manner in order to maintain the daily and weekly supplies required for performing the procedures using the surgical tents.
  • 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.
  • the first type of surgical tent is based on the principle that the interior of the surgical tent is pressurized relative to the environment by injecting a gas, thereby expanding the surgical tent. While these types of surgical tents generally do not require any stiffening elements in the area of the tent wall, 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 construction is that, on the one hand, due to unavoidable pressure losses, which, for example, occur when instruments, biopsy material, or the like are being moved in or out, a certain amount of gas can escape from the interior, and thus, gas must be continuously supplied to maintain the necessary overpressure in the interior of the surgical tent. Furthermore, a control system for monitoring the internal pressure is complex and prone to error. 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 the Approval as a medical device for surgical procedures.
  • surgical instruments such as compressed air-powered instruments or suction devices, are often operated with compressed air or negative pressure.
  • a second type of surgical tent is based on the principle of stabilizing the tent walls in an expanded state, allowing the tent to be used in an operating state where the pressure inside the tent corresponds to the ambient pressure.
  • This design avoids the need for continuously supplying a sterile gas with pressure monitoring to maintain the expanded state of the surgical tent and is therefore independent of a corresponding gas supply.
  • This type of surgical tent is therefore subject to lower requirements for approval as a medical device for surgical procedures in many countries, as no electrically operated pumps or hygienically safe gases are required to ensure operation with a sterile interior atmosphere.
  • 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.
  • WO 1986/006272 A1 describes an isolator for creating a sterile local environment on a patient, wherein a body part of the patient 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 positive pressure within the bag. This positive pressure is created and maintained by a continuous flow of filtered air from a pumping device.
  • This device also has the disadvantages explained above; in particular, it must be ensured that the continuous air flow does not introduce any contamination and that the pump works flawlessly and reliably during the operation in order to complete the operation safely.
  • 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.
  • 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.
  • US 6,793,617 B2 describes a collapsible and inflatable examination unit that has a cubic shape and inflatable tubes extend 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.
  • 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 multilayer 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 tubular structures that can be pressurized or filled with a curable foam.
  • the technique proposes a stabilizing frame structure made of internally pressurizable, curved tubes, in which several C-shaped tube segments are connected to each other at one end and at a convex-shaped central section to stabilize the surgical tent in the expanded position. It has been shown that such a configuration of the surgical tent and the stabilizing tubes can be further improved to be suitable for a variety of different surgical procedures and applications, while providing good stability in the expanded form of the surgical tent.
  • the invention is therefore based on the object of providing a surgical tent which overcomes these problems.
  • an expandable surgical tent of the type described above in which a section of the stabilizing element in the manufacturing configuration is located in a first position adjacent to a first side of a film section, and the section of the stabilizing element can be displaced by elastic deformation of the first or second film or the film section into another, second position in which it is located adjacent to another, second side of the film section, so that the section of the stabilizing element in the expanded surgical configuration is located adjacent to the other, second side of the film section.
  • 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.
  • the surgical tent itself may also have additional components, for example, valves, windows, or the like.
  • the surgical tent can be converted into a compact transport configuration.
  • the packing volume of this transport configuration is usually smaller than the surgical space enclosed by the surgical tent in the expanded surgical configuration.
  • the transport configuration is typically created from the production configuration by folding or rolling the film layers one or more 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 A 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, thereby stabilizing them like pressurized tubes or hoses.
  • the stabilizing elements which are created by connecting the film layers accordingly and are therefore part of the film layers, create an uprighting and stabilizing effect on the surgical tent, similar to a tent frame.
  • the filling of the surgical tent during expansion can occur through corresponding openings in a wall of the surgical tent.
  • 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.
  • filters can be used for this purpose.
  • a film layer can be formed by a first and a second film and, if necessary, further films.
  • the first film and the second film can basically be part of an upper film arrangement, a lower film arrangement, or part of both film arrangements, for example, by the upper and lower film arrangements each being formed from two films.
  • the first and second films are generally 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.
  • a stabilizing element is preferably formed by connecting two or more superimposed films along two linear connecting lines that run at a distance 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 around the fluid-filled volume, which provides the stiffening effect.
  • the foils adjacent to the stabilizing element as a double or multiple foil layer are formed into a shape, the desired surgical configuration, by the directly structuring contour of the stabilizing element.
  • the arrangement of at least one stabilizing element is such that, in the initial production 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 of 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 process, flipping process, turning process or the like. This displacement can generally take place in the production configuration itself, when converting the production configuration into the transport configuration, or even only in the surgical configuration.
  • This offset can also be achieved, for example, by briefly relieving the stabilizing element in the area of the section or adjacent thereto from the filling pressure within the stabilizing element, which can then be compressed or deformed and thus moved into the second position, in which it can then be filled with pressure again and stiffened.
  • This offset of the stabilizing element ensures that the stabilizing element can be reshaped from an initial arrangement into a different arrangement, thereby exerting a beneficial tensioning effect on one of the two film layers or both film layers.
  • improved stability and tension of the surgical tent can be achieved in the surgical configuration compared to a surgical configuration that is erected by simply inflating the stabilizing element from a production configuration without such an offset.
  • this process of relocating the section of the stabilizing element can also be carried out in the production configuration or before the surgical configuration is established, by moving the stabilizing element from the first position to the film section to the second position to the film section with contact on the other side. is flipped over, turned inside out, folded, or generally moved. In this case, only after such a move is the surgical tent converted into the transport and subsequent surgical configuration by performing further folding (and unfolding) and finally filling the stabilizing element.
  • 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 an arch 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 material deformation remains after the deformation has taken place.
  • the invention provides a surgical tent that can be moved from a production configuration into a compact transport configuration and which can then 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, after such a movement, quickly and reliably return to its original position.
  • the surgical tent Due to the specific self-stabilized construction and bracing of the stabilizing element by moving it from the first to the second position, the surgical tent returns elastically, quickly and reliably to its original surgical configuration under its own power after such deliberate deformation.
  • the surgical room is refilled with sterile air through a suction effect through one or more inlet openings equipped with sterile filters, thus enabling a clear view and the continuation of the operation.
  • the first and second films from which the stabilizing element is formed are films of a lower film layer
  • the film section is a component of an upper film layer which is connected to the lower film layer along at least one linear connection, that in the production configuration the lower and upper film layers lie on top of one another and can be folded together to form the flat, transportable package, and that in the expanded surgical configuration the surgical space is formed between the lower and upper film layers and enclosed by them, the volume of which is greater than the volume enclosed between the lower and upper film layers in the production position.
  • the surgical tent comprises a lower and an upper film layer, wherein the first and second films, which form the stabilizing element, are components of the lower film layer.
  • the film section around which the section of the stabilizing element is moved from the first to the second position is part of an upper film layer, which can comprise one, two, or more films, wherein the film section is preferably part of one of these films or is formed by a section of the entire upper film layer.
  • the lower and upper film layers are connected to one another and can therefore jointly enclose the surgical space as a volume and shield it from the environment in such a way that a sterile atmosphere is established and maintained within the surgical space.
  • the turning, folding, or general displacement process which causes the section of the positioning element to be moved from the first to the second position, can, in this embodiment, bring about additional bracing and stabilization between the lower and upper film layers in a particularly structurally efficient manner, for example, stabilizing a tent structure of the upper film layer or exerting a tensioning effect on the lower film layer.
  • the first and second films from which the stabilizing element is formed are film layers of an upper film layer, and the film section is a component of a lower film layer which is connected to the upper film layer along at least one linear connection, in the production configuration, the lower and upper film layers lie on top of one another and can be folded together to form the flat, transportable package, and in the expanded surgical configuration, the surgical space is formed between the lower and upper film layers and is enclosed by them, the volume of which is greater than the volume enclosed between the lower and upper film layers in the production position.
  • the stabilizing element is formed on an upper film layer and the film section on a lower film layer.
  • the lower film layer can be formed from one, two, or more film layers, and the upper film layer can be formed accordingly from two, three, four, or more films.
  • This development also creates a division of the stabilizing element section on the one hand and the film section on the other hand that is advantageous for the stability of a tent structure formed by the upper film layer and for the tensioning effect on the lower film layer, and in this way the previously explained structurally good effect can be achieved by moving it from the first to the second position.
  • first film forms a pocket by being connected to the second film in the expanded surgical position, and the section of the stabilizing element can be moved from the first position next to this pocket to the second position within this pocket by elastic deformation.
  • a pocket is formed by connecting the first and second films. This can be done, for example, by connecting the first and second films along two lines over a certain length, thereby forming a corresponding tubular pocket between them.
  • This pocket can be open on only one side, but optionally also open on both sides, i.e. can be designed as a continuous tube with an entrance on both sides.
  • the second position of the section of the stabilizing element is then within this pocket, and the section of the stabilizing element is consequently moved when moved from a position next to the pocket thus formed to a position within this pocket.
  • the first film by being connected to the second film, forms a second stabilizing element with an inner cavity that can be filled with a fluid and is delimited by the first and second films, and the section of the stabilizing element can be displaced by the elastic deformation from the first position adjacent to a first side of a section of this second stabilizing element to the second position adjacent to a second side of the section of this second stabilizing element.
  • the surgical tent comprises a first and a second stabilizing element.
  • these two stabilizing elements can be formed by a single, continuous cavity, for example a tubular cavity that has curved sections, and the two stabilizing elements are thus in a correspondingly adjacent position to one another.
  • the two stabilizing elements can preferably be formed by two separate cavities, for example by two separate tubular cavities that are formed by the first and second films alone or by a third and fourth film.
  • This can be designed, for example, in such a way that one positioning element on the first and second film can be designed as a component of an upper film layer and the second stabilizing element on the first and second film can be designed as a component of a lower film layer.
  • the preferred embodiment is characterized in that the section of the first stabilizing element is displaced from the first to the second position with respect to a section of the second stabilizing element and, consequently, in the first position, lies adjacent to a first side of this section of the second stabilizing element and, in the second position, lies on a different, second side of the second stabilizing element.
  • the section of the stabilizing element in the surgical configuration can be displaced into the second position by the elastic deformation, and the first film in the region adjacent to the section of the stabilizing element is dimensioned such that it has a first film tension in the first position and a second film tension in the second position of the section of the stabilizing element, which is higher than the first film tension.
  • the film section around which the offset of the stabilizing element from the first to the second position is carried out is immediately placed under increased film tension by this offset, thereby achieving the desired stabilizing and tensioning effect.
  • the section of the stabilizing element is an end section of a stabilizing element designed as a leg, or a curved middle section of a stabilizing element designed as an arch.
  • the section of the stabilizing element that can be moved from the first to the second position is formed by two alternative regions of the stabilizing element: on the one hand, an end section that forms the geometry of a leg, and on the other hand, a middle section that is designed as an arch, i.e., as a curved section or with curved and straight sections.
  • the variant designed as a leg can be used to set up the surgical tent and to tension a lower film layer, or can act as a leg strut that is directed laterally or upwards, exerting a tensioning effect on upper sections of the film layer in order to achieve a tensioned position of the films.
  • the curved central section can in particular be located at a symmetrical center of the stabilizing element between two ends of the stabilizing element, but can alternatively also be arranged offset from this geometric center in a region of the stabilizing element.
  • the stabilizing element is tubular and is formed by connecting, in particular welding, the first and second films along two spaced-apart lines, wherein the two spaced-apart lines preferably run at a greater distance from one another in a first and a third region than in a second region lying between the first and the third region.
  • the stabilizing element is formed by connecting, in particular welding, the first and second films along two spaced-apart lines. This forms a tubular cavity between the two lines, which can be filled with a fluid, in particular air, and pressurized, and can thereby be brought from a flexible state to a stiffened state by exerting a stabilizing effect.
  • the course of the two lines can preferably be parallel to one another over long sections, but it is particularly preferred if the distance between the two lines tapers in a certain region and then widens again, so that a central region with a reduced distance between the two lines between two adjacent regions.
  • Such a second region or central region therefore has a reduced cross-section and can be used to form a desired kink in the positioning element in the surgical configuration, thereby creating a predetermined three-dimensional geometric contour of the surgical tent in the surgical configuration.
  • the surgical tent can be defined by several such tapered sections of one or more positioning elements such that the positioning elements bend at predetermined points when erected from the production configuration into the surgical configuration, thereby achieving a specific geometry.
  • the section of the stabilizing element is formed by connecting, in particular welding, the first and second films of a first film layer along two spaced-apart connecting lines and then, externally with respect to the stabilizing element, around these connecting lines, the first and second films are connected to a third film, preferably a third and fourth film, of a second film layer by connecting, in particular welding, a connection of the first and second film layers around the section of the stabilizing element and the stabilizing element can be moved by folding in and out from a first position on a first side on the second film layer to a second position on a second side of the second film layer.
  • the surgical tent according to the invention is formed by two film layers, each comprising two films.
  • first and second films, on the one hand, and the third and fourth films, on the other hand, are to be understood as films designated separately from one another.
  • the first film layer can be formed by precisely these two films or can comprise further films; the same applies to the second film layer.
  • the stabilizing element can be formed on one of the two film layers, optionally extending across both film layers, and the film section by which the stabilizing element is offset can be formed on the other film layer or one of the two film layers, whereby efficient bracing and stabilization in the surgical configuration is achieved by offsetting the section of the stabilizing element.
  • a first and a second sleeve are arranged on a front side of the surgical tent for engaging into the surgical space
  • the section of the stabilizing element is arranged on the front side between the first and the second sleeve, or is arranged on a side wall connecting the front side to a rear side
  • a third and a fourth sleeve are arranged on the rear side of the surgical tent for engaging into the surgical space
  • a first section of the stabilizing element is arranged between the first and second sleeves
  • a second section of the stabilizing element is arranged between the third and fourth sleeves
  • a third section of the stabilizing element is arranged on a first side wall connecting the front side to a back side
  • a fourth section of the stabilizing element is arranged on a second side wall connecting the front side to a back side
  • At least two sleeves are arranged on the surgical tent, which sleeves enable access from outside the surgical tent into the surgical room in such a way that the room is shielded from germs by these sleeves.
  • the sleeves can each extend from an external sleeve opening to a hand section, which can be designed in different ways.
  • a hand section can, for example, be designed as a cuff for sealingly fitting the user's hand or wrist and be intended for use with a medical glove.
  • the hand section can also be designed as a cuff for fastening a glove, allowing the user to slip into the glove through the sleeve.
  • the sleeves are preferably surrounded by stabilizing elements or arranged between these stabilizing elements in such a way that the sleeves themselves have a certain freedom of movement relative to the stabilizing elements, thus preventing a user's arm movement from directly impacting the positioning element and immediately deforming the surgical tent.
  • the arrangement of the sleeves between the positioning elements ensures that the sleeves are stretched and positioned in a predetermined position.
  • a further aspect of the invention is a surgical tent comprising a first film layer with a first film and a second film, a second film layer with a third film and a fourth film, wherein the first and second films are connected to one another in a fluid-tight manner along two spaced-apart connecting lines and between these two connecting lines form a tubular stabilizing element, wherein furthermore the first and second film layers are connected to one another in a line-like manner and the surgical tent can be brought from a production configuration into an expanded surgical configuration, wherein in the production configuration the stabilizing element is flexible and foldable and the first and second film layers can be folded together to form a flat, transportable 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 which is larger than the packing volume, and the stabilizing element can be brought into a stiffer state than in the production configuration by filling the hollow space and stabilizes the expanded surgical configuration.
  • the surgical tent is particularly advantageously formed from two film layers, each comprising at least two films.
  • the respective two films of a film layer are advantageously connected to one another in a fluid-tight manner along two spaced-apart connecting lines, thereby forming a tubular stabilizing element, and the two film layers are connected to one another in a linear manner, thereby forming a germ-blocking barrier around a surgical space located between the two film layers.
  • a particularly compact and space-saving transport configuration is achieved by folding the two film layers from the production configuration once or multiple times.
  • the two film layers enclose a surgical space that has a larger volume than the entire surgical tent in the transport configuration.
  • the surgical tent can be advantageously developed in that it is designed according to one of the previously explained embodiments or aspects of the invention, it being understood that in this development the first and second films of these developments are preferably formed by the first and second films of the first film layer or by the third and fourth films of the second film layer or the first and second films of these developments are formed by the first and third on the one hand and the second and fourth films on the other hand in the first and second film layer.
  • the tubular stabilizing element has a first longitudinal section with a first cross-sectional area, a second longitudinal section with a second cross-sectional area, and a third longitudinal section with a third cross-sectional area, wherein the three longitudinal sections form a common, continuous inner tubular cavity, the second longitudinal section is arranged between the first and third longitudinal sections, and the second cross-sectional area is smaller than the first and third cross-sectional areas.
  • a predetermined curvature or kink is formed on the stabilizing element, thereby achieving a predetermined contour of the stabilizing element with at least two sections angled to one another in the surgical configuration.
  • the tubular stabilizing element has a fifth film which is connected to the first film in a fluid-tight manner along two spaced-apart connecting lines, preferably the two connecting lines of the first and second films, and between these two connecting lines a first tubular replacement stabilizing element is formed which is delimited by the first and fifth films, and further preferably characterized by a first filling valve for filling the tubular stabilizing element delimited by the first and second films with a fluid and a second filling valve for filling the tubular replacement stabilizing element delimited by the first and fifth films with a fluid.
  • This embodiment addresses a specific problem that can occur with fluid-filled positioning elements when they become leaky due to damage. Due to the escape of fluid and the resulting pressure reduction within the stabilizing element, the stabilizing element can lose its stiffening effect and return to a pliable state, thereby losing its stabilizing and tensioning effect on the surgical tent. In particular, such damage to a positioning element can occur as a result of the surgical procedure itself and the associated handling of sharp instruments within the surgical room. Typically, one of the two films from which the stabilizing element is composed is damaged, typically the film facing the surgical room, and the leak is caused thereby.
  • a fifth film is provided and linearly connected to the first film in such a way that a tubular cavity is also formed between the first and the fifth film, which is virtually parallel to the tubular cavity between the first and the second film.
  • This second tubular cavity between the first and fifth films is not originally filled with fluid when the surgical tent is set up in the surgical configuration, but the fifth film lies directly against the first film and thus only forms a duplication. If the inner, second film is damaged and the positioning element formed by the first and second films becomes leaky and ineffective as a result, a stiffening effect can be brought about again by filling the cavity between the first and fifth films, and this can be achieved in particular along the course of the entire stabilizing element between the first and second films.
  • the fifth film thus provides redundancy which, in the event of accidental damage, brings about a stabilizing effect exactly along and to the same extent as was originally achieved by the stabilizing element between the first and second films.
  • the tubular stabilizing element has a sixth film which is fluid-tightly connected to the second film along two spaced-apart connecting lines, preferably the two connecting lines of the first and second films, and between these two connecting lines a second tubular replacement stabilizing element is formed which is delimited by the second and sixth films, and further preferably characterized by a third filling valve for filling the tubular replacement stabilizing element delimited by the second and sixth films with a fluid.
  • a further, sixth film is arranged in the region of the stabilizing element, wherein this sixth film is adjacent to the second film and is connected to it in such a way that a tubular cavity is also formed between the second film and the sixth film, which can serve as a stabilizing element when filled with a fluid.
  • This third tubular cavity like the second tubular cavity explained above, is not initially filled with a fluid, but also serves as a redundant stabilizing element in the event that the fifth and first foils are accidentally damaged and therefore neither the original stabilizing element between the first and second foils nor the redundantly designed stabilizing element between the first and fifth foils can be filled and pressurized as a substitute.
  • the design with a sixth foil has the advantage that on both sides of the stabilizing element between the first and second foils a doubling is achieved by the fifth or sixth foil, and thus a greater wall thickness is achieved, particularly in the area of the stabilizing element, and thus a risk of damage is reduced.
  • a second advantage achieved by the double-sided doubling is that both damage caused from inside the surgical tent and the resulting leakage and damage caused from outside the surgical tent do not lead to a complete failure of the stabilising and tensioning effect, but in both cases a redundant effect for stabilisation and tension can be brought about by filling either an external cavity between the first and fifth film or an internal cavity between the second and sixth film with fluid via a separate valve, thereby creating the stabilising effect.
  • the surgical tent described at the outset or the previously explained surgical tent according to the invention can be further developed by a line access tube comprising a receiving section for receiving a rolled-up line, a constriction section connected to the surgical chamber and the receiving section and arranged between the receiving section and the surgical chamber, an environmental interface formed on the receiving section for leading a line arranged in the receiving section out into the environment, wherein the environmental interface is preferably formed by a separable film edge section or a resealable closure or a pierceable film.
  • the surgical tent according to the invention or initially explained can be further developed by a ventilation hose that connects the surgical room with the environment and has a unidirectional valve that blocks the inflow of air from the environment through the ventilation hose into the surgical room.
  • a ventilation hose allows an effective outflow of air from the surgical room into the environment at a high volume flow. This can be advantageous, for example, if an air exchange is to be carried out in the surgical room, for example to remove smoke or steam from the surgical room.
  • the surgical tent is compressed from the expanded position and its volume is reduced. This can be done by manual action from the outside. The air flows out through the ventilation hose.
  • the surgical tent then returns to the expanded position through elastic recovery and draws in air from the environment through one or more openings equipped with sterilization filters (such as so-called HEPA filters).
  • the surgical tent according to the invention or initially explained can be further developed by a battery insert tube, comprising: an instrument receiving section for an electrically operated instrument, connected to the surgical room, an insertion section for inserting an electrical energy storage device into the receiving section, and preferably a handling section arranged between the insertion section and the instrument receiving section, which is designed to receive a lid from a battery compartment of an electrically operated instrument, and preferably an environmental interface formed on the insertion section for inserting the electrical energy storage device from the environment into the insertion section, wherein the environmental interface is preferably formed by a detachable film edge section or a resealable closure or a pierceable film.
  • Such a battery insert tube makes it possible to insert a rechargeable battery or a battery into an electrically operated sterile instrument located in the surgical room from the outside from the environment.
  • a rechargeable battery or a battery cannot usually be subjected to sterilization treatment. They must therefore be inserted externally in such a way that they do not render the instrument unsterile, which is achieved by the separate environmental interface.
  • the instrument can be inserted from the surgical room into the instrument receiving section with the opening for inserting the rechargeable battery facing the environmental interface.
  • the optionally provided handling section allows for the removal of a cover for the instrument's battery compartment and its replacement after the rechargeable battery has been inserted.
  • a further aspect of the invention is 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, said surgical space having an interior volume which is larger than the transport volume, wherein at least one first sleeve section fastened to a film layer is provided, which first sleeve section extends, in the surgical configuration, 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, wherein a first cuff for releasably fastening a first glove is arranged on the first hand section, said first cuff comprising an elastically deformable ring which has a first circumferential outer annular groove on a first end section, a second circumferential outer annular groove on a second end section opposite the first,
  • An elastically deformable ring is understood here to be a preferably cylindrical ring which can be deformed into an oval or elliptical shape by exerting manual force, wherein the diameter is reduced by at least 10% along an axial direction. This makes it possible to pass a hand through the ring and then allow the ring to return to a cylindrical shape with a small diameter, which is favorable for freedom of movement of the wrist and for putting on a glove.
  • the inner diameter of the elastically deformable ring can preferably be 10-30% larger than the largest transverse dimension of a human wrist, preferably approximately 8 to 13 cm.
  • a further aspect of the invention is an erectable tent arrangement for creating an enclosed work space, which is designed in the manner of the previously explained surgical tent, wherein the work space corresponds to the surgical room.
  • This aspect of the invention extends the design and functionality of the surgical tent to generally usable tents for enclosing a work space, which serve, for example, as weather protection, and which in particular can also have dimensions that are significantly larger than the surgical tent and can completely enclose a person or even allow several people to enter the work space.
  • the inventive concept of the surgical tent is particularly well suited for such use because it is self-stabilized and does not rely on pressurizing a fluid-tight, enclosed work space in order to remain stable in the erected configuration.
  • the tent can therefore also be used with larger side openings for entering, inserting work equipment or tools or the like.
  • An expandable surgical tent for providing an enclosed, sterile environment around a surgical site, comprising: one or more film layers which o are compactly placed on top of one another in a transport configuration and occupy a transport volume, and o in an expanded surgical configuration enclose a surgical space and insulate it from the environment, the surgical space having 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 their 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 aspect 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 open to the surgical room and an outer sleeve surface open to the surroundings of the surgical tent.
  • Surgical tent according to aspect 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 formed by the first and the second hose section, and the first and the second hand section are arranged at the ends of the two legs, or the first and the second sleeve section form a Y-configuration, in which the entrance opening is arranged at the base of the Y-configuration, the two legs of the Y-configuration are formed by the first and the second hose section, the first and the second hand section 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 the second hose section to the entrance opening, or the first sleeve
  • Surgical tent according to one of the preceding aspects, 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.
  • Surgical tent according to one of the preceding aspects, 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.
  • 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.
  • Surgical tent according to the preceding aspect 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.
  • Surgical tent according to aspect 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 aspect 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 aspects, 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 aspects, characterized in that the surgical tent can be brought from a manufacturing configuration into an expanded surgical configuration, wherein
  • 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
  • the first and second film layers enclose a surgical space with a volume that is larger than the packing volume
  • the stabilizing element can be set into a stiffer state than in the manufacturing configuration by filling the cavity and stabilizes the expanded surgical configuration, wherein preferably a section of the stabilizing element in the manufacturing configuration lies in a first position adjacent to a first side of a film section, and the section of the stabilizing element can be set into another, second position in which it lies adjacent to another, second side of the film section by elastic deformation of the first or second film layer or the film section, so that the section of the stabilizing element in the expanded surgical configuration lies adjacent to the other, second side of the film section.
  • Surgical tent according to one of the preceding aspects or the generic term of aspect 1, characterized 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.
  • Surgical tent according to aspect 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.
  • Surgical tent according to aspect 13 or 14, characterized in that the disinfection tube section comprises a film which encloses the disinfection interior and the closure is effected by a detachable connection of the film or by a detachable puncture film connected to the film.
  • Surgical tent according to aspect 13, 14 or 15, characterized in that the surgical tent comprises a connecting section for releasably fastening the disinfection hose section, and the disinfection hose section is designed to be releasably fastened to the connecting section, wherein preferably the closure is formed on the connecting section.
  • Surgical tent according to one of aspects 13 to 16, characterized in that the disinfection hose section has a first disinfection chamber which is enclosed by a first and a second film and has a first access opening to the first disinfection chamber arranged in the first film at a first end section. has an access chamber which is enclosed by the second and a third film and is connected or connectable to the surgical chamber, 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 chamber into the access chamber.
  • Method according to aspect 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 one of aspects 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.
  • An expandable surgical tent for providing an enclosed, sterile environment around a surgical site, preferably according to any one of the preceding aspects 1-23, comprising: a first film layer with a viewing window recess, a viewing window, characterized in that the viewing window is bonded 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, the weld seam extending in cross section over the viewing window, the pressure-sensitive adhesive tape and the first film layer.
  • Surgical tent according to claim 24 characterized in that the viewing window consists of a first material and the first film layer consists of a second material which has a lower melting temperature than the first material.
  • Surgical tent according to one of the preceding aspects, characterized in that the viewing window has a greater wall thickness than the first film layer.
  • Surgical tent according to one of the preceding aspects, characterized in that the viewing window consists of PET or comprises PET and the first film layer consists of EVA or comprises EVA.
  • Surgical tent according to one of the preceding aspects, characterized in that the viewing window and the first film layer consist of non-colored plastic, in particular are transparent.
  • Surgical tent according to one of the preceding aspects, characterized by at least one stabilizing element which is formed by a connection of the first and a second film layer, which, through the connection, delimit an inner, closed cavity which can be filled with a fluid, wherein the surgical tent can be brought from a manufacturing configuration into an expanded surgical configuration, wherein
  • the stabilizing element is flexible and foldable and the surgical tent can be folded into a flat, transportable package with a packing volume
  • the surgical tent encloses an operating room with a volume that is larger than the packing volume, and the stabilizing element can be set into a stiffer state than in the manufacturing configuration by filling the cavity and stabilizes the expanded surgical configuration in a pressure state in which the air pressure in the operating room inside the surgical tent and in the environment outside the surgical tent is the same.
  • Method according to aspect 31 or 32 characterized in that the contact element comprises a material permeable to light or consists of such a material.
  • Method according to one of aspects 31 to 33 characterized in that the electromagnetic beam is a laser beam.
  • Method according to one of aspects 31 to 34 characterized in that the contact element is a glass sphere and the electromagnetic beam is a laser beam in the visible wavelength range.
  • Method according to one of aspects 31 to 35 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.
  • Method according to aspect 36 characterized in that 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.
  • Method according to aspect 37 characterized in that in the first step the film layers are adhesively connected to the support surface along the first connecting line.
  • Method according to one of aspects 31 to 38 characterized in that the film layers are bonded together by means of a double-sided adhesive tape before welding and the welding extends in cross section through the first film, the adhesive tape and the second film.
  • Device for welding two layers of plastic film comprising: a contact element movable along a connecting line for placement on the film layers, an energy source for introducing thermal energy along the connecting line for welding the film layers, characterized in that the contact element is rotatably mounted in a bearing and is designed to be moved by rolling the contact element along the connecting line, and the energy source is a beam emitter of an electromagnetic beam, and the electromagnetic beam emitted from the beam emitter is directed onto the contact element and is guided by the contact element to the connecting line of the film layers.
  • Device according to aspect 40 characterized in that the contact element is a rotationally symmetrical body, in particular a sphere.
  • Device according to aspect 40 or 41, characterized in that the contact element comprises a material which is transparent to light or consists of such a material.
  • Device characterized in that the contact element is a glass sphere and the beam emitter is a laser beam source for emitting a laser beam in the visible wavelength range.
  • Device characterized by a support surface made of a plastic which has a higher melting temperature and/or lower absorption rate for the wavelength of the electromagnetic beam than the two film layers, and characterized in that that the beam emitter is designed to emit the electromagnetic beam with such an energy density that the lower film layer is releasably and adhesively bonded to the support surface in the region of the connecting line.
  • Figure 1 a-h a schematic representation of the manufacturing steps for a surgical tent according to the invention
  • Figure 2a-f A schematic representation of the process of manufacturing and erecting a surgical tent according to the invention with a structure of the stabilizing elements according to a first embodiment
  • Figure 3a-g a schematic representation of the process of manufacturing the erection of a surgical tent according to the invention with a structure of the stabilizing elements according to a second embodiment
  • 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
  • Figure 5a-e an embodiment of a support structure with kinks according to the invention 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
  • 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
  • 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
  • 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
  • Figure 9a, b a schematic representation of a double valve connection for filling the support structures of a surgical tent according to the invention
  • 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.
  • Figure 11 a-h A schematic representation of the process of manufacturing and using a surgical tent according to the invention with an extremity disinfection hose
  • Figure 13 A schematic, partially sectioned view of a cutting knife according to the invention for cutting one or more film layers for a surgical tent,
  • Figure 14a-c A schematic, longitudinal section of a stabilizing element with redundancy against damage from both sides
  • 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
  • Fig. 17a-c a schematic representation of a line hose for sterile removal of a line from the surgical room
  • Fig. 18a,b a schematic representation of a surgical tent according to the invention with ventilation hose
  • Fig. 19 a-d 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
  • FIG. 20a-l a schematic representation of a sterile container tube according to the invention.
  • 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
  • FIGs 1a-h schematically illustrate the manufacturing sequence for a surgical tent according to the invention.
  • the starting point is two film layers 10, 20, which, for example, as shown in Figure 1a, can be formed as film layer 10 from two superimposed films 10a, b and are available, for example, as wound roll material. From these two film layers 10, 20, an upper film layer 10 and a lower film layer 20 are formed, as shown in Figure 1b. Both film layers 10, 20 are first connected to one another along predetermined lines 11, 12, 21, 22, which can be done in particular by welding.
  • 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 basically 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; in certain applications, however, films of different material types and/or different thicknesses can be joined together, or correspondingly different film layers can be used for the upper and lower film layers.
  • the film layers are preferably formed from EVA films.
  • the viewing window welded into the upper film layer is preferably made of a different material, for example PET.
  • 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.
  • a completely external welding line 16 which surrounds the other welding lines to be produced, and to set welding parameters that ensure a releasable adhesion of the film layer to the support surface. This will ensure that the film The film layer is detachably fastened to the support surface along this circumferential welding line, thereby avoiding unwanted creases or unwanted shifting of the film layer on the support surface or of the films relative to one another.
  • the surgical tent structure produced in this way is separated from the film layers using a cutting device, see Figures 1 e and 1 f.
  • the cutting device can be designed as a movable knife that follows a corresponding contour line around the welded film layers from which the surgical tent is formed.
  • the surgical tent can then be removed, see Figure 1 f, and is now in a flat, pliable manufacturing state A.
  • 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.
  • the thickness DF of the welded film layers lying on top of one another - gfs. with a welded 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 regularly smaller than 10 cm, in particular smaller than 5 cm.
  • this production configuration From this production configuration, it can be folded once or several times into a compact transport position - see Figure 1 g1) - and thus easily transported and stored without taking up much storage space.
  • this transport configuration typically has a dimension in the longitudinal direction LT and transverse direction QT of less than half of 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 Manufacturing configuration, depending on the number of folds, this can be double, triple or quadruple or a larger multiple of the thickness of the manufacturing configuration.
  • 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).
  • one or more openings equipped with sterile filters are formed on the surgical tent. Through these openings, sterile air from the environment can be drawn into the interior of the surgical tent when the tent is erected due to the stiffening of the stabilizing elements.
  • Figure 1h shows the surgical tent in the surgical configuration in a top view (left), a front view (top right), and a side view (bottom right).
  • the surgical tent has larger dimensions than in the transport configuration.
  • 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
  • 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 at the top and allow a good view into the surgical room inside the surgical tent. If necessary, another viewing window or a coupling device for diagnostic optics or radiotherapy equipment can be provided at a central location 17.
  • Two sleeves 41a, 42a are formed on each of the two side walls 40a, b, into which a user can insert their arms, thus gaining access to the surgical room for performing an operation.
  • 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.
  • 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.
  • 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.
  • an outwardly lying lower surface section 128a of the lower film layer 120 is glued to an inwardly lying lower surface section 128b of the lower film layer.
  • the two film sections thus take on the shape shown in Figure 2c.
  • the surgical tent stands up and assumes the surgical configuration shown in Figure 2d on the right and Figure 2e.
  • the 180° fold of the stabilizing element opens partially, in the example shown by approximately 90°, and on the one hand an upright support leg 115a is created, and on the other hand the lower film layer 120 is stretched and thus brought into a largely wrinkle-free position in the erected state of the surgical tent.
  • the adhesive bond 128 and unfolding 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).
  • the unfilled area "A” denotes a film
  • the uniformly lighter filling "B” denotes an air-inflatable stabilizing element
  • the uniformly darker filling "C” denotes a cut surface.
  • Figure 3a shows an upper film layer 210 and a lower film layer 220 prior to their connection.
  • 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.
  • 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.
  • the leg section is folded inwards instead of simply folding over by 180°.
  • Figure 3c shows in perspective the process from Figure 3b, how the erecting support leg 215 and the protruding outer film section of the lower film layer 220, which is already connected to it at the outer circumference 280, are simultaneously turned inwards until the two assume a position folded 180° inwards to the starting position... This process and the associated effects are also described below with reference to Figures 3a-g.
  • the surgical tent erects and assumes the surgical configuration shown in Figure 2d (right) and Figures 2e and 2f.
  • the 180° fold and the resulting invagination of the stabilizing element opens partially, in the example shown by approximately 90°, creating upright support legs 215a on the one hand, and tensioning the lower film layer 220 on the other.
  • the lower film layer 220 lies on the outside in the area of the support legs 215a-d and thus forms four external pockets 290, which are formed by a lateral connection of the pockets between the upper and lower film layers.
  • the vertically positioned support legs are inserted into these pockets 290 and thus come into contact with the other side of the lower film layer.
  • this 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.
  • Figure 4a shows a third embodiment of an upper film layer 310 and a lower film layer 320.
  • both film layers have a stabilizing element 315, 325, which is formed by welding along an inner circumferential line and an outer circumferential line 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.
  • 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.
  • the leg section 325b rests on the downward-facing surface 316b1 of the film section 316b. As can be seen in Fig. 4b), this leg section 325b is then folded inwards and, after this folding, rests against the formerly 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.
  • 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.
  • the stabilizing elements By inflating the stabilizing elements with a fluid such as air, they are transformed from the flexible 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. It should be understood that the folding process of the not yet filled stabilizing element, as shown in Fig.
  • the surgical tent 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).
  • the leg section 325b and the film section 316b would then lie on the outside of the leg section 315b.
  • 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.
  • the stabilizing elements can be designed as essentially tubular structures with connection and intersection points, formed by welding two film layers along two parallel lines.
  • 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.
  • FIG 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.
  • 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.
  • 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.
  • 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 Figure 5b and 5c. In this way, the surgical tent can be erected into a stable and predetermined three-dimensional shape with predefined bending points of the stabilizing elements. Circled in Figures 5d and 5e are corresponding predefined bending points 415d,e,f, which can be defined by such a tapering of a stabilizing element.
  • Figures 6a-f illustrate the fluid-tight attachment of a viewing window 613 in the region of a section of a film layer 610 made of EVA film(s).
  • a first embodiment is shown in Figures 6a-c and a second embodiment in Figures 6d-f.
  • 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 trapezoidally, with the dimensions of the trapezoidal PET window 613 being larger than the dimensions of the trapezoidal cutout in the EVA film layer.
  • 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.
  • 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, after removal of a lamination 631, on the EVA film layer 610.
  • Figure 6b shows the subsequent manufacturing step.
  • the PET window 613 is bonded to the EVA film layer 610 using the adhesive tape 630, thereby securing it in position.
  • the connection is welded to a sufficient strength to ensure load-bearing capacity and a secure seal along the entire circumference.
  • the PET window which in this manufacturing 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.
  • 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.
  • Figure 6e shows the subsequent manufacturing step.
  • 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 lubricious EVA edge of the lamination on the back. 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.
  • 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.
  • the welding head 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 weld line 655, is shown in Figure 6c.
  • FIGS 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 corresponding 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.
  • 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 room.
  • This second sleeve portion 730 is arranged adjacent to the first sleeve portion 720 such that the first sleeve portion 720 can be inserted into the second sleeve portion 730.
  • the second sleeve section 730 extends from a sleeve entry opening 731 to a hand section 732.
  • the sleeve entry opening 731 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).
  • This embodiment can, as can be seen from Figure 7d, be designed for two separate sleeve sections 720a, b, each having a corresponding second sleeve section 730a, b above it.
  • a user can thus conveniently operate a device to be operated outside the surgical tent, for example an irradiation device, an optical observation device or the like, by pushing their hand into the second sleeve section 730 or their two hands together with the first sleeve section 720 or 720a, b into the two second sleeve sections 730a, b.
  • they can operate such devices outside the surgical room without the risk of contaminating the surgical room, for example by adjusting a focus, achieving an alignment or pressing a button or the like.
  • Figures 8a-d show a second embodiment of such a sleeve arrangement.
  • 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.
  • the lateral outward extension 825 has at its upper end a second sleeve section 830, 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, and thereby inserting the hand together with the first sleeve section 820 into the second sleeve section so far that the first hand section 822 reaches the second hand section 832.
  • a device or instrument arranged outside the surgical room 801 can therefore be reached and operated by hand, as can be seen in Figure 8c.
  • this embodiment can also provide for two first sleeve sections 820a, b to be provided on the surgical tent and each to be 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 in Figure 8d.
  • 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.
  • 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.
  • the surgical tent be shaped and held in the desired form 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.
  • the double valve shown in Figures 9a, b allows 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
  • the lower film layer has two 521, 522. These are arranged in a
  • the end region is widened and dimensioned in such a way 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 thereby sealed.
  • This welding essentially forms 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 third film 521 are also welded together at the end 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 side.
  • the end faces of the two uppermost films 511, 512 and the two lower films 521, 522 are not welded together and thus form an opening that can be conveniently used with an insert piece of a pumping device.
  • the mouthpiece can then 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.
  • Figures 10a and b show a second embodiment of a double valve according to the invention for a surgical tent.
  • 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.
  • all four film layers 911-922 extend the same distance in the manner of a leg-shaped elongated section.
  • a circular cutout 990 in the uppermost film layer 911 and a similarly designed circular cutout 991 in the lowermost film layer 922 enable access of a mouthpiece to the stabilizing element 915 formed between the uppermost film layer 911 and the second film layer 912.
  • FIG. 10b shows this structure in a partially sectioned view in the lower part of the figure.
  • 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 it is introduced into the surgical room.
  • the surgical tent is brought into a production configuration and, in this case, 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, if necessary, cut to size.
  • the two superimposed film layers are then, in Figure 11 b, also subjected to such welding along predetermined lines, whereby the two film layers are connected to one another in a gas-tight manner and enclose a surgical room 1000.
  • an elongated attached hose 1070 is included on one end side of the surgical tent. This tube 1070 is formed by welding the two film layers along two edge lines 1071, 1072.
  • Figure 11c shows the embodiment of this surgical tent in the surgical configuration.
  • the extremity disinfection hose 1070 extends from one end of the surgical room to a specifically designed end section 1073, explained below.
  • 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).
  • the arm 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.
  • the extremity disinfection tube is gathered accordingly to allow the arm to be advanced.
  • a leg 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, or carried out from the surgical room by reaching into the space between the films 1070b, c, on the other.
  • 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.
  • 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
  • the underlying second film layer 1320 has a correspondingly dimensioned slit 1321, the size of which is adapted to the opening 1311.
  • 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.
  • 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.
  • the extremity tube accordingly has an upper encapsulated volume 1315 arranged between the first and second foils 1310, 1320, and a second volume 1345 between the third and fourth foils 1330, 1340, which pass through the first extremity opening 1311 and the second extremity opening 1341, respectively. are accessible. Between these two volumes 1315 and 1345, a central encapsulated volume 1325 is arranged between the second and third foils 1320, 1330, which is accessible from the upper and lower volumes through the slots 1321 and 1331.
  • a more precise, germ-proof fit to extremities of different thicknesses can be achieved by arranging several, here three, film sections one above the other, each with, for example, round openings of different and staggered sizes, 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.
  • the appropriate opening is selected, and all openings smaller than this selected opening can either be used to closely fit a tapered geometry of the extremity or can be cut or torn to facilitate the passage of the extremity.
  • the opening of the film located further outwards has a larger diameter than the opening 1311 or 1341 below it, and these stacked openings thus form several sealing lips towards the extremity and enable an optimized and size-variable adaptation to the almost conical anatomy of the forearm and lower leg.
  • 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.
  • a disinfectant liquid using a syringe, as shown in Figure 12g, h.
  • FIG 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.
  • the knife shaft 1120 is in turn arranged in a bushing 1130 that is axially displaceable with respect to the rotational axis 1101.
  • the bushing 1130 is supported against a support head 1140 by a helical spring.
  • 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.
  • 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.
  • 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 produces the stabilizing effect.
  • a further film 1211 Arranged externally to and adjacent to film 1212 is a further film 1211, which is connected to film 1212 to form a fluid-tight interior space 1203.
  • a further film 1214 Arranged externally to and adjacent to film 1213 is a further film 1214, which is connected to film 1212 to form a fluid-tight interior space 1202.
  • the three separate interior spaces 1201, 1202 and 1203 can be filled with fluid by means of separate valves 1201", 1202' and 1203'.
  • a redundant stabilizing element can be constructed by filling the interior space 1202 through the valve 1202'. 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'.
  • Figure 15 shows a glove ring that allows a glove to be attached to a sleeve and changed without breaching 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 each arranged at the end, and the annular groove 1420 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.
  • a sleeve 1450 and a glove 1460 placed over it can be fastened in the left and right edge annular grooves 1440 by slipping them over the ring one after the other 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.
  • 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.
  • 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.
  • the central ring groove 1420 is formed less deep than the two peripheral ring grooves 1410, 1440, and the cylindrical surface 1430 is correspondingly wide and raised.
  • Figure 16 shows the schematic sequence of the manufacturing process for a surgical tent in an arrangement with two double film layers.
  • 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).
  • a second double film layer which also already has such welding lines in the same way, but which can run differently than in the first double film layer, is placed on the first double film layer ( Figure 16c).
  • a connection is again created by welding along predetermined lines, which in this case extends over all four superimposed films, thereby creating a connection and forming a cavity between the two double film layers ( Figures 16e, f).
  • FIG 17 shows another preferred configuration of a surgical tent with the possibility of sterile discharge of hose connections, electrical supply connections, and the like.
  • the surgical tent has a receiving bag 1510 on one side, which can be arranged at the front or side, which 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).
  • 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).
  • FIG 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 obscures visibility.
  • the ventilation hose 1610 preferably has a one-way valve, thereby preventing air from entering the surgical room through the ventilation hose 1610.
  • Figures 19a-d show a preferred embodiment of a resealable opening with the option of connecting a hose to the surgical tent.
  • external, circumferential locking groove hook elements 1711 are arranged in three rows on a hose connection 1710 formed on the surgical tent in an annular end section. More or fewer rows can also be used here.
  • 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 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 to release the closed state of the closure elements 1712, thereby connecting the internal volumes of the connected hose and the surgical space.
  • Figures 20a-l show another preferred configuration of a surgical tent according to the invention. This configuration serves to connect a sterile container to the 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.
  • the sterile container lock 1800 is connected to the surgical tent via a hose 1810, which is designed as a lock by means of a double closure 1811, 1812.
  • the sterile container S can be inserted into a receiving space 1820 from an opposite hose connection 1830, which is also closed from the environment by means of a closure 1831.
  • 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.
  • 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.
  • FIG 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.
  • 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.
  • connection section 1960 specifically formed by two foils or a double foil arrangement, is formed in the shape of a distorted L on a receiving section 1920, which may be identical to the receiving section 1820 or may be designed separately.
  • This connection section 1960 allows an electrical device EG to be pushed out of the receiving section 1920 into this L-shaped connection section 1960, wherein this electrical device EG is pushed into the L-shaped connection section 1960 with the insertion end of the battery pack or accumulator pack first.
  • 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 area at the end that can be penetrated by pre-perforation.
  • the L-shaped connection section 1960 is rotated and brought directly closer to the battery compartment.
  • the tube section 1930 is inserted into the upper area of the battery compartment so that the battery can be pierced through the perforation with slight pressure and inserted directly into the battery compartment without touching sterile parts.
  • the battery compartment can be closed and the electrical device can be inserted into the surgical room ( Figures 21 e, f).

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Abstract

L'invention concerne une tente chirurgicale pouvant être déployée, destinée à fournir un environnement stérile fermé autour d'un site chirurgical, laquelle comprend : un premier film, un second film, au moins un élément de stabilisation qui est formé par un assemblage du premier et second film qui délimitent sous l'effet de l'assemblage une cavité intérieure fermée pouvant être remplie d'un fluide, la tente chirurgicale pouvant passer d'une configuration de fabrication à une configuration chirurgicale déployée. L'invention se caractérise en ce que dans la configuration de fabrication, une partie de l'élément de stabilisation se trouve dans une première position à proximité d'une première face d'une partie de film, et la partie de l'élément de stabilisation peut être déplacée, par déformation élastique du premier ou du second film ou de la partie de film, dans une autre position, une seconde position, dans laquelle elle est adjacente à une autre face, une seconde face, de la partie de film, de telle sorte que dans la configuration de chirurgie déployée, la partie de l'élément de stabilisation se trouve à proximité de l'autre face, la seconde face de la partie de film.
PCT/EP2024/075651 2023-09-15 2024-09-13 Tente chirurgicale à élément de stabilisation déplaçable Pending WO2025056760A1 (fr)

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DE102023125027.2 2023-09-15
DE102023125027.2A DE102023125027A1 (de) 2023-09-15 2023-09-15 Chirurgiezelt mit versetzbarem Stabilisierungselement

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Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1986006272A1 (fr) 1985-04-23 1986-11-06 Lone Star Medical Products, Inc. Isolateur utilise en chirurgie
GB2216056A (en) * 1988-03-17 1989-10-04 Cambridge Isolation Tech Glove boxes
US6793617B2 (en) 2003-02-12 2004-09-21 Thomas E. Ford Portable and disposable examination unit with air tube frame
US7037254B2 (en) 2000-10-17 2006-05-02 O'connor Michael Controlled environment device
US20080051817A1 (en) * 2004-04-26 2008-02-28 Patrick Leahy Surgical Device
US20140163326A1 (en) 2011-07-15 2014-06-12 Milux Holding S.A. Convertible surgical access port
EP3236865B1 (fr) 2014-12-23 2021-01-27 Surgitent GmbH Dispositif de fourniture d'un espace limité stérile pour une chirurgie
US20210290337A1 (en) * 2016-07-15 2021-09-23 Surgibox Inc. Ultraportable system for intraoperative isolative and regulation of surgical site environments
WO2022016017A1 (fr) * 2020-07-15 2022-01-20 S.W.O.R.D. International Inc. Tente de lutte contre les infections pour une intubation
WO2022182394A1 (fr) * 2021-02-28 2022-09-01 Surgibox Inc. Système portable pour l'isolement et la régulation d'environnements de sites chirurgicaux

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006095849A1 (fr) * 2005-03-11 2006-09-14 Nipro Corporation Tente aseptisee

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1986006272A1 (fr) 1985-04-23 1986-11-06 Lone Star Medical Products, Inc. Isolateur utilise en chirurgie
GB2216056A (en) * 1988-03-17 1989-10-04 Cambridge Isolation Tech Glove boxes
US7037254B2 (en) 2000-10-17 2006-05-02 O'connor Michael Controlled environment device
US6793617B2 (en) 2003-02-12 2004-09-21 Thomas E. Ford Portable and disposable examination unit with air tube frame
US20080051817A1 (en) * 2004-04-26 2008-02-28 Patrick Leahy Surgical Device
US20140163326A1 (en) 2011-07-15 2014-06-12 Milux Holding S.A. Convertible surgical access port
EP3236865B1 (fr) 2014-12-23 2021-01-27 Surgitent GmbH Dispositif de fourniture d'un espace limité stérile pour une chirurgie
US20210290337A1 (en) * 2016-07-15 2021-09-23 Surgibox Inc. Ultraportable system for intraoperative isolative and regulation of surgical site environments
WO2022016017A1 (fr) * 2020-07-15 2022-01-20 S.W.O.R.D. International Inc. Tente de lutte contre les infections pour une intubation
WO2022182394A1 (fr) * 2021-02-28 2022-09-01 Surgibox Inc. Système portable pour l'isolement et la régulation d'environnements de sites chirurgicaux

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