Connection device for creating a vacuum-tight fluidic connection between a vacuum wound dressing and a vacuum source, vacuum wound therapy kit, and vacuum wound therapy system
Patent Information
- Application Number
- EP2023822375
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-12-19
- Filing Date
- 2023-12-13
- Publication Date
- 2025-10-29
AI Technical Summary
Existing connection devices for negative-pressure wound therapy are costly due to the materials used for supporting the connecting tube against collapse under negative pressure, which affects the overall cost-effectiveness and patient comfort.
A connecting device featuring a flat material web section with elevations that form a continuous space within the tube lumen, allowing for fluid permeability and preventing collapse, made from materials like polyethylene or polyurethane, which are flexible and supportive yet inexpensive.
The solution provides a cost-effective and comfortable connection that maintains negative pressure for wound therapy while preventing tube collapse, ensuring effective fluid transport and patient comfort through the use of a flat material web section with elevations, allowing for reliable vacuum-tight fluidic connection.
Smart Images

Figure 1.1
Abstract
Description
[0001] Title: Connection device for the vacuum-tight fluidic connection of a negative pressure wound dressing with a negative pressure source, negative pressure wound therapy kit and negative pressure wound therapy system
[0002] Description
[0003] The present invention relates to a connecting device for the vacuum-tight fluidic connection of a negative pressure wound dressing to a negative pressure source. The present invention also relates to a negative pressure wound therapy kit with such a connecting device. Furthermore, the present invention relates to a negative pressure wound therapy system comprising a negative pressure source and such a negative pressure wound therapy kit. Negative pressure therapy of wounds, also called NPWT = Negative Pressure Wound Therapy, is an innovative method for wound treatment with a wide range of indications. These include, for example, acute skin or soft tissue defects, impaired wound healing, chronic wounds, etc. The aim of negative pressure therapy is to stimulate the growth of granulation tissue and promote the healing process.In negative pressure therapy, a negative pressure is created in the area of a wound, whereby wound exudate can be effectively drained from the wound.
[0004] Negative pressure wound dressings used in negative pressure therapy typically comprise an air-impermeable cover layer for airtight closure of the wound. A connection opening for the vacuum-tight fluidic connection of the wound space to a vacuum source is formed in the cover layer. When the negative pressure wound dressing is applied to a wound as intended and the vacuum source is fluidly connected to the connection opening in a vacuum-tight manner, a negative pressure can be created in the wound space by the negative pressure source. Typically, a connecting device comprising an elongated single-lumen or multi-lumen connecting tube is used for the vacuum-tight fluidic connection of the negative pressure wound dressing to the vacuum source. A proximal end section of the connecting tube can be fluidly connected to the vacuum source in a vacuum-tight manner.A distal end section of the connecting tube can be fluidically connected to the negative-pressure wound dressing in a vacuum-tight manner. To prevent the connecting tube from collapsing due to negative pressure during use in negative-pressure therapy, a support unit is typically arranged in a tube lumen of the connecting tube. The support unit is permeable to fluids such as air and, in particular, wound exudate along the length of the tube lumen.
[0005] A generic connecting device is known, for example, from the published specification WO 2012 087 376 A1. Various designs of the support unit are proposed. For example, the support unit can comprise an open-cell foam, a spacer fabric or a nonwoven fabric. Another generic connecting device is described in the published specification WO 2013 175 306 A1. Accordingly, the support unit can comprise a porous material such as, for example, a three-dimensional knitted fabric. The support units described in WO 2012 087 376 A1 and WO 2013 175 306 A1 do meet the basic requirements for a support unit. However, the proposed materials result in relatively high costs. This was accepted with previously known connecting devices.The invention is based on the object of providing a possibility for a connecting device for the negative pressure therapy of wounds to ensure effective support of the connecting tube using cost-effective means.
[0006] This object is achieved according to the invention by a connecting device according to claim 1, by a negative pressure wound therapy kit according to claim 21 and by a negative pressure wound therapy system according to claim 22.
[0007] The subclaims and the description indicate advantageous variants and embodiments.
[0008] According to the invention, a connecting device is provided for the vacuum-tight fluidic connection of a vacuum wound dressing to a vacuum source. The connecting device comprises an elongated single- or multi-lumen connecting tube, in particular a film tube, which has a distal end section and a proximal end section. The distal end section can be fluidically connected to the vacuum wound dressing in a vacuum-tight manner. The proximal end section can be fluidically connected to the vacuum source in a vacuum-tight manner.
[0009] The terms "distal" and "proximal" describe the arrangement relative to the vacuum source. A proximal portion of an element is located closer to the vacuum source than a distal portion of the same element. For example, when used as intended, the proximal end portion of the connecting tube is located closer to the vacuum source than the distal end portion.
[0010] A "vacuum-tight fluidic connection" is understood here to mean that, taking into account the vacuum source used, the negative pressure required for negative pressure wound therapy can be maintained in the fluidically connected cavities. Typically, during negative pressure therapy, a pressure difference is set between the air pressure within the negative pressure wound dressing and the ambient air pressure, which is at least 20 mm Hg (millimeters of mercury) and at most 250 mm Hg. 1 mm Hg corresponds to one Torr or 133.322 Pa (Pascal).
[0011] The connecting device according to the invention further comprises a support unit arranged in a tube lumen of the connecting tube. The support unit supports the connecting tube against collapse, particularly due to negative pressure, and is permeable to fluids such as air and, in particular, wound exudate along the longitudinal extent of the tube lumen.
[0012] It is now provided that the support unit comprises at least one flat material web section, that the flat material web section for supporting the connecting tube is structured by elevations formed integrally with a plane of the flat material web section, and that a continuous intermediate space is formed between the elevations, so that fluid such as air and in particular wound exudate can be transported through the intermediate space in the longitudinal extension of the tube lumen.
[0013] It has surprisingly been found that a flat material web section designed as above is, in view of its properties, particularly suitable as a support unit or as a component of a support unit. The continuous intermediate space is formed between the elevations according to the invention. A vacuum can be communicated into a vacuum wound dressing through the fluid-permeable intermediate space by means of a vacuum source. As a result of this vacuum, a tube wall of the connecting tube is subjected to an inwardly directed compressive force.
[0014] In particular, this compressive force causes a section of the hose wall opposite the raised portions to cling to the raised ends of the raised portions. However, this does not close the interconnected space, thus reliably preventing the connecting hose from collapsing. Collapse of the connecting hose is understood to mean closure of the connecting hose.
[0015] A flat material web section designed according to the invention is available at low cost. This is due in particular to the fact that the formation of the elevations can be advantageously integrated into the manufacture of the flat material web section. The use of a flat material web section as a support unit or as a component of a support unit further has the advantage that a connecting tube with a low overall height can be realized. Such a flat connecting tube is associated with a high level of patient comfort.
[0016] A flat material web section is a section of a flat material web. For example, the flat material web section is cut out of a flat material web. Preferably, the elevations are already formed in the flat material web. However, the elevations can also be formed in the flat material web section. In particular, the flat material web is a plastic film web, so the flat material web section is formed as a plastic film.
[0017] Preferably, the flat material web section has a protrusion density of at least 50 protrusions per cm 2 to , preferably a protrusion density of at least 100 protrusions per cm 2 , particularly preferably a protrusion density of at least 200 protrusions per cm 2. Such high elevation densities are accompanied by small-sized elevations. The stability of the flat material web section is then only slightly impaired by the elevations and any end openings present. On the other hand, a limitation of the elevation density is also advantageous in order to achieve sufficiently large distances between adjacent elevations for fluid permeability. The flat material web section preferably has an elevation density of at most 1000 elevations per cm 2 on , preferably a density of not more than 500 elevations per cm 2 . Particularly preferably, the flat material web section has a protrusion density of at least 200 protrusions per cm 2 up to a maximum of 400 elevations per cm 2 on .
[0018] The connecting tube can be single-lumen or multi-lumen. In a single-lumen connecting tube, there is only a single tube lumen, which extends from the distal end section to the proximal end section. When the connecting device is used as intended, the tube lumen serves as a suction lumen. In a multi-lumen connecting tube, the tube lumen is divided into several partial lumens, each of which extends from the distal end section to the proximal end section. The partial lumens are preferably connected parallel to one another to an inlet opening formed in the distal end section, with each of the partial lumens being assigned its own passage in the region of the proximal end section. In such a multi-lumen connecting tube, a first of the partial lumens serves as a suction lumen when the connecting device is used as intended.A second of the partial lumens can be used, for example, as a flushing lumen and / or as a measuring lumen. According to a preferred embodiment, the elevations are conical, cylindrical, truncated pyramid-shaped or hyperboloid-shaped. Elevations shaped in this way can effectively support the hose wall of the connecting hose. In addition, a highly branched intermediate space is created. This has the advantage that the transport of fluid is still possible even if the intermediate space is blocked at isolated points, for example between two adjacent elevations. The elevations are preferably arranged in island-like isolation from one another. The elevations preferably have a height of 200 m to 1000 m.
[0019] According to a preferred embodiment, at least in a central region of the flat material web section, each of the elevations is surrounded by three to eight additional elevations, the additional elevations together forming a regular polygon. Such an arrangement of the elevations ensures particularly effective support of the hose wall. Particularly preferably, the additional elevations form a regular hexagon.
[0020] According to a preferred embodiment, the elevations are formed on a first side of the flat material web section, and a second side of the flat material web section facing away from the first side is smooth. It has been shown that elevations on only one side of the flat material web section are sufficient for effective support of the hose wall. In addition, a continuous intermediate space on only one side of the flat material web section also achieves sufficient permeability for fluid in the longitudinal extent of the hose lumen. A flat material web section with a smooth second side is easy to manufacture.
[0021] A "smooth side" of a layer should not be understood here to mean that the smooth side is necessarily free of any unevenness. Rather, a "smooth side" means a side that is smooth compared to the first side of the flat material web section, which is structured by the elevations. Accordingly, unevenness can also be present on a smooth side of a layer, for example due to irregularities in the material thickness of the layer in question. However, any unevenness is of a smaller order of magnitude in terms of its height than the elevations on the structured first side of the flat material web section.
[0022] The elevations are preferably formed by vacuum deep drawing. Such a formation of the elevations can be integrated into the production of the flat material web or the flat material web section in a time-saving manner. For example, a calendered or extruded, still molten flat material web, in particular a plastic film web, is guided over a rotating vacuum perforating roller. The flat material web is then drawn section by section into holes in the vacuum perforating roller by a vacuum in the vacuum perforating roller, whereby the elevations are formed. The shape of the resulting elevations is determined, for example, by the contour of the holes and the level of vacuum used.
[0023] According to a preferred embodiment, the flat material web section is made of polyethylene, polyurethane, polyvinyl chloride, or a mixture thereof. These plastics are particularly suitable for the formation of the flat material web section due to their properties. Firstly, the plastics are sufficiently flexible, which is associated with a high level of patient comfort. For example, a flexible design of the connecting tube can prevent pressure ulcers. Furthermore, a sufficiently rigid flat material web section can be realized, ensuring that the elevations can securely support the tube wall.
[0024] According to a preferred embodiment, it is provided that an end-side through-opening is formed in at least some of the elevations, in particular in all elevations. The distribution of fluid, in particular wound exudate, in the tube lumen can be improved by the end-side through-openings. Specifically, fluid can pass through the flat material web section through the end-side through-openings and then distribute itself on both sides of the flat material web section in the tube lumen. The end-side through-openings can be formed in a simple manner in terms of production technology. Preferably, the negative pressure used in vacuum deep drawing is set such that the end sides of at least some of the elevations open. The elevations and the end-side through-openings are then formed in the same process step. The presence of the end-side through-openings is preferred.However, the disclosure also covers flat material web sections in which there are no through openings at the ends.
[0025] Preferably, the diameter of the end-side passage openings is at least 100 m, more preferably at least 200 m. Preferably, the diameter of the end-side passage openings is at most 1000 m, more preferably at most 500 m. More preferably, the diameter of the end-side passage openings is at least 200 m and at most 500 m.
[0026] According to a preferred embodiment, at least one plane-side through-opening is formed in the plane of the flat material web section. The distribution of fluid, in particular wound exudate, in the tube lumen can also be improved by one or more plane-side through-openings. In addition, the plane-side through-openings have the advantage that they can be formed independently of the elevations. For example, the plane-side through-openings are formed after the elevations and any end-side through-openings have been formed by punching in the flat material web or in the flat material web section. In particular, the plane-side through-openings are arranged between the elevations. However, the plane-side through-openings can also overlap the elevations.This is the case, for example, when the plane-side through-openings are formed by punching, with part of a raised portion being punched out during punching. Preferably, the plane-side through-openings are present in addition to the end-side through-openings. However, the plane-side through-openings can also be present instead of the end-side through-openings. Furthermore, the disclosure also covers flat material web sections in which neither plane-side through-openings nor end-side through-openings are present.
[0027] Preferably, the flat material web section extends into the distal end section. Accordingly, the distal end section is also supported against collapse by the flat material web section.
[0028] According to a preferred embodiment, at least one plane-side through-opening is formed in the region of the distal end section in the plane of the flat material web section. Such an arrangement is particularly preferred for plane-side through-openings. When the connecting device is used in negative pressure therapy, wound exudate enters the connecting tube in the region of the distal end section. Plane-side through-openings in the region of the distal end section increase the permeability of the flat material web section in this area. Accordingly, wound exudate can already be effectively distributed on both sides of the flat material web section in the region of the distal end section. In particular, one or more plane-side through-openings are present only in the region of the distal end section.
[0029] According to a preferred embodiment, the connecting tube comprises an elongated central section, and the distal end section is widened over a larger area than the central section. By widening the distal end section, the contact surface between the distal end section and the negative pressure wound dressing is increased. By enlarging the contact surface, a mechanically particularly robust connection between the negative pressure wound dressing and the distal end section can be realized. In addition, any unevenness in the negative pressure wound dressing can be more easily compensated for by the flatly widened distal end section. The distal end section is preferably widened in the shape of a circular disk or a rectangle.According to a preferred embodiment, the connecting tube comprises a first layer and a second layer, wherein the layers are connected to one another in their edge regions and together enclose the tube lumen. Such a multi-layer design of the connecting tube facilitates the arrangement of the support unit in the tube lumen. For example, during the production of the connecting device, the first layer, the support unit, and the second layer are stacked on top of one another. Only then are the first layer and the second layer connected to one another in their edge regions.
[0030] According to a preferred embodiment, the first layer is at least substantially flat, and the flat material web section extends parallel to the first layer. A flat first layer has the advantage that a flat contact of the connecting tube with the wound dressing or with the surrounding tissue can be ensured. The alignment of the flat material web section parallel to the first layer is preferred because this prevents the flat material web section from being kinked or otherwise deformed when the connecting device is used in negative pressure therapy.
[0031] According to a preferred embodiment, the distal end portion comprises at least one inlet opening, and the inlet opening is formed in the flat first layer. This facilitates the vacuum-tight fluidic connection of the distal end portion to the negative-pressure wound dressing. The flat first layer can advantageously be adapted to a region of the cover layer of the negative-pressure wound dressing that encompasses the connection opening.
[0032] According to a preferred embodiment, the elevations extend away from the first layer. In the elevations, the wound exudate is transported by capillary forces toward the end openings. If the elevations extend away from the first layer, the capillary forces accordingly support the transport of wound exudate through the flat material web section. The wound exudate can then be effectively distributed on both sides of the flat material web section.
[0033] According to a preferred embodiment, the flat material web section is loosely inserted into the tube lumen. Such a connecting device can be implemented during production in a time-saving manner and with few work steps. Alternatively, the flat material web section is connected to the connecting tube, for example, by an adhesive bond or a welded joint.
[0034] According to a preferred embodiment, a resiliently deformable connecting plate is arranged on the distal end section, the tube lumen being fluidically connected to the environment through at least one through-opening formed in the connecting plate. The tube lumen can then be fluidically connected to the negative pressure wound dressing in a vacuum-tight manner through the through-opening in the connecting plate. The contact surface between the connecting device and the negative pressure wound dressing is increased by the connecting plate, so that a secure connection can be achieved. Preferably, a first side of the connecting plate facing away from the distal end section is at least partially adhesive. For example, a double-sided adhesive tape is arranged on the first side of the connecting plate.
[0035] According to a preferred embodiment, the support unit comprises at least one further flat material web section, the further flat material web section is structured to support the connecting tube by elevations formed integrally with a plane of the further flat material web section, a continuous intermediate space is formed between the elevations so that fluid such as air and in particular wound exudate can be transported through the intermediate space in the longitudinal extent of the tube lumen, and the flat material web section and the further flat material web section are arranged stacked one above the other. By providing at least one further flat material web section, a tube lumen with a larger cross-section can be supported.The features described in connection with the flat material web section can be used to further configure the further flat material web section. The flat material web sections are preferably of identical design. However, the flat material web sections can also differ from one another in at least one feature, for example in the shape of the elevations and / or the material composition. The presence of several flat material web sections stacked one above the other is preferred. However, the disclosure also covers support units with only one flat material web section.
[0036] Preferably, the flat material web sections are arranged such that the elevations of the flat material web sections protrude in the same direction. This results in the advantage that the space between the elevations of one flat material web section is not blocked by the elevations of the other flat material web section. Such a blockage of the space could otherwise impair the transport of fluid.
[0037] According to a preferred embodiment, an air-permeable and liquid-impermeable filter unit is arranged in the tube lumen, which filtering effect is effected between an inlet of the connecting tube and an outlet of the connecting tube. Because the filter unit is designed to be air-permeable, a negative pressure can be communicated through the filter unit into the receiving space. Because the filter unit is designed to be liquid-impermeable, the filter unit prevents liquid such as wound exudate from entering the downstream negative pressure source when the connecting device is used in negative pressure therapy. The negative pressure source could otherwise be contaminated and / or damaged. The filter unit is preferably arranged in the region of the proximal end section.
[0038] The object to be achieved is also achieved by a negative pressure wound therapy kit which comprises a negative pressure wound dressing and a connecting device with the features described above, wherein the distal end section of the connecting device can be fluidically connected to the negative pressure wound dressing in a vacuum-tight manner, and wherein the proximal end section of the connecting device can be fluidically connected to a negative pressure source in a vacuum-tight manner.
[0039] Regarding the advantages achievable with the negative pressure wound therapy kit, reference is made to the relevant information on the connecting device. The features described in connection with the connecting device can be used to further configure the negative pressure wound therapy kit.
[0040] The object to be achieved is also achieved by a negative pressure wound therapy system comprising a negative pressure wound therapy kit with the features described above. The negative pressure wound therapy system according to the invention also comprises a negative pressure source, wherein the proximal end section of the connecting tube can be fluidly connected to the negative pressure source in a vacuum-tight manner.
[0041] Regarding the advantages achievable with the negative pressure wound therapy system, reference is made to the relevant information on the connecting device. The features described in connection with the connecting device can be used to further refine the negative pressure wound therapy system.
[0042] The invention is described in more detail below with reference to the figures, wherein identical or functionally identical elements may be provided with reference symbols only once. The figures serve as examples and are not to be understood as limiting.
[0043] Fig. 1 shows a negative pressure wound therapy system with a connecting device comprising an elongated connecting tube,
[0044] Fig. 2 is a longitudinal section through the connecting hose shown in Figure 1,
[0045] Fig. 3 shows a cross section through the connecting hose shown in Figure 1,
[0046] Fig. 4 is a plan view of a flat material web section arranged in a tube lumen of the connecting tube, Fig. 5 is a sectional view of the flat material web section shown in Figure 4 along the section line AA,
[0047] Fig. 6 shows a longitudinal section through another embodiment of the connecting hose,
[0048] Fig. 7 is a plan view of another embodiment of the connecting device and
[0049] Fig. 8 shows a cross section through another embodiment of the connecting hose.
[0050] Figure 1 shows a negative pressure wound therapy system 10 for use in the negative pressure therapy of wounds. The negative pressure wound therapy system 10 comprises a negative pressure source 12 and a negative pressure wound therapy kit 14. The negative pressure wound therapy kit 14 comprises a negative pressure wound dressing 16, which is referred to below as wound dressing 16. The wound dressing 16 comprises a wound contact layer for application to the wound bed of a wound and an air-impermeable cover layer 20. The wound contact layer is concealed by the cover layer 20 in Figure 1 and is therefore not visible. The negative pressure wound therapy kit 14 also comprises a connecting device 22. The connecting device 22 comprises an elongated connecting tube 24 with a proximal end section 26 and a distal end section 28. The proximal end section 26 can be fluidly connected to the vacuum source 12 in a vacuum-tight manner.The distal end portion 28 is fluidly connectable in a vacuum-tight manner to a connection opening 21 formed in the cover layer 20. In the negative pressure wound therapy system 10 shown in Figure 1, the distal end portion 28 is already connected to the connection opening 21, so that the connection opening 21 is concealed by the distal end portion 28.
[0051] The distal end section 28 is widened flat compared to an elongated central section 30 of the connecting tube 24. In the present case, the distal end section 28 is widened in the shape of a circular disk. The widening of the distal end section 28 facilitates the connection of the distal end section 28 to the connection opening 21 of the wound dressing 16.
[0052] The structure of the connecting device 22 is explained in more detail below with additional reference to Figures 2 and 3. Figures 2 and 3 show a schematic longitudinal section and a schematic cross section, respectively, through the connecting hose 24 shown in Figure 1.
[0053] In the present embodiment, the connecting hose 24 comprises a lower or first layer 32 and an upper or second layer 34. The layers 32 and 34 are connected to one another in their edge regions 33 and 35 and together enclose a hose lumen 38 of the connecting hose 24. The first layer 32 and the second layer 34 form the hose wall of the connecting hose 24. In the present case, the layers 32 and 34 are designed as film layers. Accordingly, the connecting hose 24 is a film hose.
[0054] Preferably, layers 32 and 34 are made of polyurethane, polyvinyl chloride, polyethylene, silicone, or a mixture thereof. Preferably, edge regions 33 and 35 of layers 32 and 34 are joined together by an adhesive bond or a welded bond. An adhesive bond can be created, for example, by applying an adhesive or using an adhesive tape. A welded bond can be created, for example, by heat or ultrasound.
[0055] The first layer 32 is at least substantially flat. If the connecting device 22 is connected to the wound dressing 16 as intended, the first layer 32 faces the wound dressing 16. Because the first layer 32 is at least substantially flat, a flat contact of the first layer 32 with the wound dressing 16 or with the surrounding tissue is ensured. The second layer 34 is curved outwards.
[0056] The distal end portion 28 includes an inlet opening 36. The inlet opening 36 is formed in the first layer 32. If the distal end portion 28 is connected to the wound dressing 16 as intended, as shown in Figure 1, the connection opening 21 in the wound dressing 16 and the inlet opening 36 are aligned with one another at least in sections.
[0057] In the embodiment shown in Figures 1, 2 and 3, the connecting tube 24 has a single lumen, as can be seen from Figure 3. Accordingly, the tube lumen 38 is not divided into several partial lumens. When the connecting device 22 is used as intended, the tube lumen 38 serves as a suction lumen. To connect the tube lumen 38 to the vacuum source 12, a connecting element 42 projects into the tube lumen 38 in the region of the proximal end section 26 through a passage formed between the edge region 33 of the first layer 32 and the edge region 35 of the second layer 34.
[0058] The connecting device 22 also comprises a support unit 46, which supports the connecting tube 24 against collapse, in particular due to negative pressure. The support unit 46 comprises a plurality of flat material web sections 48-1, 48-2 and 48-3. The flat material web sections 48-1, 48-2 and 48-3 are arranged in the tube lumen 38 and extend in the longitudinal extent of the connecting tube 24. In the present case, the flat material web sections 48-1, 48-2 and 48-3 extend from the proximal end section 26 into the distal end section 28.
[0059] The design of the flat material web sections 48 is explained in more detail below with additional reference to Figures 4 and 5. Figure 4 shows a plan view of one of the flat material web sections 48. It should be noted that Figure 4 only shows a section of the flat material web section 48. Accordingly, the actual outer contour of the flat material web section 48 deviates from the outer contour shown in Figure 4. Figure 5 shows a sectional view of the flat material web section 48 along the section line AA shown in Figure 4.
[0060] The flat material web section 48 extends in two surface directions X and Y. To support the connecting tube 24, a first side 50 of the flat material web section 48 is structured by elevations 54 formed integrally with a plane 52 of the flat material web section 48. A continuous intermediate space 56 is formed between the elevations 54. Fluid such as air and in particular wound exudate can be transported through the intermediate space 56 in the longitudinal extension of the tube lumen 38.
[0061] In at least some of the elevations 54, an end-side through-opening 58 is formed in the raised end sides 60 of the respective elevations 54. In the present case, an end-side through-opening 58 is formed in each of the elevations 54. Fluid can pass through the flat material web section 48 through the end-side through-openings 58 and then be distributed on both sides of the flat material web section 48.
[0062] The second side 62 of the flat material web section 48 facing away from the structured first side 50 is smooth.
[0063] Preferably, the flat material web section 48 on the first side 50 has a protrusion density of at least 200 protrusions 54 per cm 2 up to a maximum of 400 elevations 54 per cm 2 The density of the elevations is approximately 280 (54 elevations per cm) 2 . Preferably, the diameter of the end passage openings 58 is at least 200 m and at most 500 m. The height of the elevations 54 is preferably at least 200 m and at most 1000 m.
[0064] To form the continuous intermediate space 56, the elevations 54 are arranged in island-like configurations, isolated from one another. In the illustrated embodiment, the elevations 54 are shaped like a single-layer hyperboloid. In this case, the elevations 54 are thus hyperboloid-shaped. A peripheral wall of the elevations 54 is anticlastically curved for this purpose. Alternatively, the elevations 54 are preferably conical, i.e., truncated cone-shaped, cylindrical, or truncated pyramid-shaped.
[0065] The elevations 54 are distributed such that, at least in a central region of the flat material web section 48, each of the elevations 54 is surrounded by three to eight further elevations 54, wherein the further elevations 54 together form a regular polygon. In the present case, the further elevations 54 together form a regular hexagon. Thus, at least in the central region of the flat material web section 48, each of the elevations 54 is surrounded by six further elevations 54.
[0066] The flat material web section 48 is a plastic film 48 in the present case. The plastic film 48 is preferably made of polyethylene, polyurethane, polyvinyl chloride, or a mixture thereof. These plastics have the advantage of providing a flexible connecting tube 24, which is associated with high patient comfort. For example, the flexible design of the connecting tube 24 can prevent the occurrence of pressure ulcers. Furthermore, the aforementioned plastics also exhibit sufficient rigidity. In this respect, the plastics ensure that the continuous space 56 is maintained when the connecting device 22 is used, despite the negative pressure created.
[0067] The elevations 54 are manufactured by vacuum deep drawing. For this purpose, an extruded or calendered, still meltable flat material web, in particular a plastic film web, is preferably guided over a rotating vacuum perforated roller. The flat material web is then drawn into holes in the vacuum perforated roller in some areas by a vacuum in the vacuum perforated roller, whereby the elevations 54 are formed. The shape of the resulting elevations 54 is determined, for example, by the contour of the holes and by the vacuum used. The vacuum in the vacuum perforated roller is preferably set such that the end sides 60 of the elevations 54 open. The elevations 54 and the end through openings 58 are thus formed in the same process step.
[0068] The flat material web sections 48 are arranged parallel to the flat first layer 32 in the tube lumen 38. The flat material web sections 48 are arranged such that the elevations 54 extend in the direction of the second layer 34, i.e. away from the first layer 32. This supports the transport of wound exudate through the flat material web sections 48 in the direction of the second layer 34, so that the wound exudate is distributed on both sides of the flat material web sections 48. Specifically, capillary forces act on the wound exudate in the elevations 54, which promote transport in the direction of the second layer 34.
[0069] In the embodiment illustrated in Figures 1, 2, and 3, three flat material web sections 48 are arranged in the tube lumen 38. However, a number of flat material web sections 48 other than three may also be present. Accordingly, more than three flat material web sections 48 or fewer than three flat material web sections 48 may be present.
[0070] The flat material web sections 48 are in the
[0071] Tube lumen 38 is loosely inserted. Alternatively, the
[0072] Flat material web sections 48 are connected to the first layer 32 and / or to the second layer 34, for example by an adhesive connection or by a welded connection.
[0073] Figure 6 shows a representation of a further exemplary embodiment of the connecting hose 24, corresponding to Figure 2. The connecting hose 24 shown in Figure 6 differs from the connecting hose 24 shown in Figure 2 in that, in the region of the distal end section 28, a plurality of plane-side through-openings 64 are formed in the planes 52 of the flat material web sections 48. For example, the plane-side through-openings 64 are formed by punching in the flat material web sections 48. The plane-side through-openings 64 can already be formed in the flat material web or only in the flat material web sections 48. The plane-side through-openings 64 increase the permeability of the flat material web sections 48 for wound exudate.The presence of through openings 64 on the plane side is advantageous especially in the region of the distal end section 28 because then an effective distribution of wound exudate orthogonal to the surface directions X and Y already takes place in the distal end section 28.
[0074] In the embodiment illustrated in Figure 6, the plane-side through-openings 64 are present in addition to the end-side through-openings 58. According to a further embodiment, the plane-side through-openings 64 are present instead of the end-side through-openings 58. In such an embodiment, one or more plane-side through-openings 64 are preferably also formed in the flat material web sections 48 outside the distal end section 28.
[0075] Figure 7 shows a further exemplary embodiment of the connecting device 22. In the connecting device 22 shown in Figure 7, a resiliently deformable connecting plate 66 is arranged on the distal end section 28. The tube lumen 38 is fluidically connected to the environment through at least one through-opening formed in the connecting plate 66, said through-opening not being visible in Figure 7. The through-opening in the connecting plate 66 is at least partially aligned with the inlet opening 36 of the distal end section 28. The connecting plate 66 can be used to create a mechanically particularly robust connection between the wound dressing 16 and the connecting device 22. Specifically, the connecting plate 66 increases the contact area between the connecting device 22 and the cover layer 20 of the wound dressing 16.Preferably, a first side of the connecting plate 66 facing away from the distal end section 28 is at least partially adhesive. Accordingly, an adhesive connection can be produced between the connecting plate 66 and the cover layer 20. Figure 8 shows a representation corresponding to Figure 3 of a further exemplary embodiment of the connecting tube 24. In the exemplary embodiment shown in Figure 8, the connecting tube 24 is designed with multiple lumens. For this purpose, the tube lumen 38 is divided into a first partial lumen 38-1 and a second partial lumen 38-2.
[0076] The two partial lumens 38-1 and 38-2 are fluidically connected parallel to one another to the inlet opening 36 of the distal end section 28. In the region of the proximal end section 26, the two partial lumens 38-1 and 38-2 each comprise their own passage. When the multi-lumen connecting tube 24 is used as intended, the first tube lumen 38-1 is used as a suction lumen. The second tube lumen 38-2 can be used, for example, as a rinsing lumen and / or as a measuring lumen.
[0077] To form the two partial lumens 38-1 and 38-2, the first layer 32 is partially connected to the second layer 34 in a materially bonded manner, preferably by welding.
[0078] In the illustrated embodiment, the flat material web sections 48 extend both in the first partial lumen 38-1 and in the second partial lumen 38-2. The material-to-material connection between the first layer 32 and the second layer 34 is an indirect material-to-material connection, namely a material-to-material connection by means of the support layers 48 of the support unit 46. Preferably, the indirect material-to-material connection is realized by welding. In this case, the first layer 32, the second layer 34 and the support layers 48 located therebetween are heated in some regions to a temperature above their melting temperature and are thereby welded together. Specifically, the first layer 32 in the present case is directly material-to-material connected to the first flat material web section 48-1. The second layer 34 is directly material-to-material connected to the third flat material web section 48-3.In addition, the flat material web sections 48 are connected to one another in a materially bonded manner.
[0079] According to a further embodiment, the flat material web sections 48 extend only in the first partial lumen 38-1 used as a suction lumen. With such an arrangement of the flat material web sections 48, the material-fit connection between the first layer 32 and the second layer 34 is preferably a direct material-fit connection.
Claims
Patent claims 1. A connecting device (22) for the vacuum-tight fluidic connection of a vacuum wound dressing (16) to a vacuum source (12), comprising an elongated single-lumen or multi-lumen connecting tube (24), in particular a film tube, which comprises a distal end section (28) and a proximal end section (26), wherein the distal end section (28) can be fluidically connected to the vacuum wound dressing (16) in a vacuum-tight manner, and wherein the proximal end section (26) can be fluidically connected to the vacuum source (12) in a vacuum-tight manner, and comprising a support unit (46) which is arranged in a tube lumen (38) of the connecting tube (24), wherein the support unit (46) supports the connecting tube (24) against collapse, in particular due to vacuum, and is permeable to fluid in the longitudinal extent of the tube lumen (38), characterized in that the support unit (46) has at least comprises a flat material web section (48),that the flat material web section (48) for supporting the connecting hose (24) is formed integrally with a plane (52) of the flat material web section (48), shaped elevations (54) is structured, and that a continuous intermediate space (56) is formed between the elevations (54) so that fluid can be transported through the intermediate space (56) in the longitudinal extension of the tube lumen (38).
2. Connecting device (22) according to claim 1, characterized in that the elevations (54) are conical, cylindrical, truncated pyramid-shaped or hyperboloid-shaped.
3. Connecting device (22) according to one of claims 1 and 2, characterized in that at least in a central region of the flat material web section (48) each of the elevations (54) is surrounded by three to eight further elevations (54), wherein the further elevations (54) together form a regular polygon, in particular a regular hexagon.
4. Connecting device (22) according to one of claims 1 to 3, characterized in that the elevations (54) are formed on a first side (50) of the flat material web section (48), and that a second side (62) of the flat material web section (48) facing away from the first side (50) is smooth.
5. Connecting device (22) according to one of claims 1 to 4, characterized in that the elevations (54) are formed by vacuum deep drawing.
6. Connecting device (22) according to one of claims 1 to 5, characterized in that the flat material web section (48) is made of polyethylene, polyurethane, polyvinyl chloride or a mixture thereof.
7. Connecting device (22) according to one of claims 1 to 6, characterized in that in at least some of the elevations (54), in particular in all elevations (54), an end-side through opening (58) is formed.
8. Connecting device (22) according to one of claims 1 to 7, characterized in that at least one plane-side through-opening (64) is formed in the plane (52) of the flat material web section (48).
9. Connecting device (22) according to one of claims 1 to 8, characterized in that the flat material web section (48) extends into the distal end section (28).
10. Connecting device (22) according to claim 9, characterized in that at least one plane-side through-opening (64) is formed in the region of the distal end section (28) in the plane (52) of the flat material web section (48).
11. Connecting device (22) according to one of claims 1 to 10, characterized in that the connecting tube (24) comprises an elongated central section (30), and that the distal end section (28) is widened in a planar manner compared to the central section (30), in particular wherein the distal end section (28) is widened in a circular disk shape or rectangular shape.
12. Connecting device (22) according to one of claims 1 to 11, characterized in that the connecting tube (24) comprises a first layer (32) and a second layer (34), wherein the layers (32, 34) are connected to one another in their edge regions (33, 35) and together enclose the tube lumen (38).
13. Connecting device (22) according to claim 12, characterized in that the first layer (32) is at least substantially planar, and in that the flat material web section (48) extends parallel to the first layer (32).
14. Connecting device (22) according to claim 13, characterized in that the distal end portion (28) comprises at least one inlet opening (36), and that the inlet opening (36) is formed in the first layer (32).
15. Connecting device (22) according to claim 14, characterized in that the elevations (54) of the Flat material web section (48) extending away from the first layer (32).
16. Connecting device (22) according to one of claims 1 to 15, characterized in that the flat material web section (48) is loosely inserted into the tube lumen (38), or that the flat material web section (48) is connected to the connecting tube (24), in particular by an adhesive connection or by a welded connection.
17. Connecting device (22) according to one of claims 1 to 16, characterized in that a resiliently deformable connecting plate (66) is arranged on the distal end section (28), wherein the tube lumen (38) is fluidically connected to the environment through at least one through-opening formed in the connecting plate (38).
18. Connecting device (22) according to one of claims 1 to 17, characterized in that the support unit (46) comprises at least one further flat material web section (48), that the further flat material web section (48) for supporting the connecting hose (24) is structured by elevations (54) formed integrally with a plane (52) of the further flat material web section (48), that between the elevations (54) a continuous space (56) is formed so that fluid flows through the space (56) is transportable in the longitudinal extension of the tube lumen (38), and that the flat material web section (48) and the further flat material web section (48) are arranged stacked one above the other.
19. Connecting device (22) according to claim 18, characterized in that the flat material web sections (48) are arranged such that the elevations (54) of the flat material web sections (48) protrude in the same direction.
20. Connecting device (22) according to one of claims 1 to 19, characterized in that an air-permeable and liquid-impermeable filter unit is arranged in the tube lumen (38), which filtering effect is effected between an inlet of the connecting tube (24) and an outlet of the connecting tube (24).
21. Negative pressure wound therapy kit (14) with a negative pressure wound dressing (16) and with a connecting device (22) according to one of claims 1 to 20, wherein the distal end section (28) of the connecting device (22) is fluidly connectable to the negative pressure wound dressing (16) in a vacuum-tight manner, and wherein the proximal end section (26) of the connecting device (22) is connected to a negative pressure source (12) can be fluidly connected in a vacuum-tight manner.
22. Negative pressure wound therapy system (10) with a negative pressure wound therapy kit (14) according to claim 21 and with a negative pressure source (12), wherein the proximal end section (26) of the connecting device (22) can be fluidly connected to the negative pressure source (12) in a negative pressure-tight manner.