Island bandage for wound treatment with acrylate adhesive in the border area and silicone gel in the wound contact area

Abstract

The invention relates to a bandage (1, 13, 19, 22, 23, 24) for wound treatment, comprising an adhesive backing layer (2, 3), a wound pad (4) and a silicone-coated wound contact layer (5, 6, 7). With the invention an island bandage for wound treatment is provided, which can be well adhered at the wound site, but can also be removed again from the wound site without causing pain and without damaging the wound surface. In a preferred embodiment, the bandage is also provided for negative pressure wound therapy.

Description

[0001] This invention relates to a bandage for wound treatment. The bandage includes a backing layer and a first adhesive layer disposed on the side of the backing layer facing the wound. Additionally, the bandage includes a wound pad and a wound contact layer. Here, the wound pad is disposed between the backing layer and the wound contact layer. The backing layer with the first adhesive layer extends beyond both the wound pad and the wound contact layer, such that the bandage has a first adhesive edge formed by the backing layer and the first adhesive layer. The invention also relates to a kit having the above-described bandage and a system for negative pressure wound therapy having the above-described bandage.

[0002] In the prior art, wound bandages having a perforated wound contact layer coated with silicone adhesive are known. Here, the perforated, silicone-coated wound contact layer covers the entire side of the bandage facing the wound. The bandage is then secured to the patient's body with the silicone adhesive. Such bandages are also used in negative pressure wound therapy.

[0003] Silicone adhesives are typically formulated to have weak adhesion and are non-invasive. They can adhere weakly to dry skin around a wound (but not normally on the wound surface). This type of wound bandage therefore has the particular advantage of being able to be removed from the wound site painlessly and without damaging the wound or the surrounding healthy skin.

[0004] However, such silicone-coated wound bandages may sometimes detach from the wound site prematurely. This is attributed to the relatively low adhesive strength of the silicone adhesive, as already mentioned. This low adhesive strength can be particularly disadvantageous when bandages are used in negative pressure wound therapy. Because in this form of wound treatment, the bandage must adhere airtightly to the wound site and cannot be left unsealed. Otherwise, the desired negative pressure cannot be established within the wound space.

[0005] To address the aforementioned problems, the bandage can be additionally secured and sealed to the wound site with adhesive tape at its edges. This is illustrated, for example, in WO 2011 / 144888 A1 and shown in Figure 24D. However, applying the adhesive tape introduces an additional step for caregivers. It is desirable to eliminate the need for secondary bandage material as suggested in WO 2011 / 144888 A1, without causing the bandage to prematurely detach from the wound site or become loose. This would reduce the workload for caregivers and allow for more cost-effective patient treatment.

[0006] The object of this invention is to provide an improved bandage for wound treatment, particularly for negative pressure wound therapy. This bandage should adhere well to the wound site, thereby minimizing the formation of a gap during wound treatment and preventing premature detachment from the wound site. For the new bandage, additional secondary bandage material (such as the previously mentioned adhesive strip) for fastening and sealing should be largely eliminated, thereby allowing for simpler, faster, and more cost-effective application. Simultaneously, the bandage should be easily removable from the wound site, allowing for painless replacement without damaging the wound surface. The stated object is achieved using the bandage for wound treatment according to claim 1, the kit for negative pressure wound therapy according to claim 22, and the system for negative pressure wound therapy according to claim 23.

[0007] The bandage according to the invention includes a backing layer and an adhesive layer disposed on the side of the backing layer facing the wound. In the present context, the adhesive layer of the backing layer is also referred to as a "first adhesive layer." Additionally, the bandage includes a wound pad and a wound contact layer.

[0008] The wound pad is disposed between the backing layer and the wound contact layer. The backing layer, having a first adhesive layer, extends not only beyond the wound pad but also beyond the wound contact layer, such that the bandage has an adhesive edge composed of the backing layer and the first adhesive layer. In the present case, the adhesive edge of the bandage is also referred to as the "first adhesive edge". The bandage according to the invention is thus designed as an island bandage.

[0009] The unique feature of the bandage according to the invention lies in the special construction of the wound contact layer and the special combination of adhesives. Thus, the first adhesive layer is composed of an acrylic adhesive. Furthermore, the wound contact layer is composed of a perforated carrier foil, with adhesive layers arranged on both the wound-facing and wound-removing sides of the carrier foil. Currently, the wound-facing adhesive layer of the carrier foil is also referred to as the "second adhesive layer." This second adhesive layer is composed of a silicone gel. Currently, the wound-removing adhesive layer of the carrier foil is also referred to as the "third adhesive layer." This third adhesive layer, like the first adhesive layer, is composed of an acrylic adhesive. This third adhesive layer particularly functions to connect the wound contact layer to the wound liner. The perforations in the carrier foil of the wound contact layer are not closed by the second and third adhesive layers. These perforations therefore penetrate all layers of the wound contact layer, thereby allowing wound exudate to seep into the bandage and enabling negative pressure to be transmitted to the wound surface.

[0010] Acrylic adhesives can have high adhesion and are typically more cost-effective than silicone adhesives. Therefore, by having an edge with an acrylic adhesive, the bandage according to the invention can adhere well to the wound site. Thus, in the case of current bandages, additional secondary bandage material for securing and sealing is generally unnecessary. Through this silicone-coated wound contact layer, the bandage according to the invention can be removed from the wound site again without causing pain or damaging the wound surface. Additionally, the wound contact layer with silicone gel can help adhere the bandage to the dry, intact skin surrounding the wound. The bandage according to the invention can also contain a smaller amount of the more expensive silicone adhesive because the silicone-coated wound contact layer forms only a portion of the bandage's wound-facing side. Therefore, simple, quick, cost-effective, and gentle wound treatment can be performed overall with the help of current bandages. Further advantages of the bandage according to the invention are derived from the preferred embodiments of the invention given below.

[0011] The terms "facing the wound" and "away from the wound" refer to the intended position of the bandage on the patient's body. Specifically, the side of the bandage layer facing the wound is the side that faces the wound when the bandage is used as intended. Typically, this wound-facing side is the bottom surface. Conversely, the side of the bandage layer away from the wound is the side that faces away from the wound when the bandage is used as intended. Typically, this wound-away side is the top surface.

[0012] The backing layer is the outermost layer of the bandage. It defines the bandage outwards, protects the wound from contamination, and secures the bandage with the first adhesive at the wound site. The backing layer can be a closed, continuous layer. However, when the bandage is configured for negative pressure wound therapy, the backing layer advantageously has an opening for evacuating air within the range of the negative pressure wound therapy. This opening allows the bandage to be in fluid communication with the negative pressure source. Since the backing layer is the carrier of the first adhesive layer, the opening in the backing layer also extends into the first adhesive layer. That is, the opening exists not only in the backing layer but also in the first adhesive layer. The opening can, for example, be designed to be substantially circular and have a diameter of 0.5 to 2.5 cm.

[0013] The backing layer can be made of various materials. For example, it can be composed of non-woven fabric or a liquid-impermeable but water-vapor-permeable plastic foil. If the bandage is intended for negative pressure wound therapy, then the embodiment using plastic foil is particularly preferred. The liquid-impermeable but water-vapor-permeable plastic foil can be, for example, composed of polyurethane.

[0014] Preferably, the entire wound-facing side of the backing layer is coated with the first adhesive layer. The wound pad can then be easily secured at the back side. However, alternatively, it is also possible to coat the wound-facing side of the backing layer with the first adhesive only in the area of ​​the first adhesive edge. In this case, the wound pad can be surrounded and secured by the wound contact layer in the bandage. The second adhesive edge is described more accurately below. When only the edge of the backing layer is adhesively coated, the bandage can be breathable.

[0015] The adhesive strength of the first adhesive layer can be greater than 2.8 N / 25 mm, preferably greater than 3.5 N / 25 mm, and particularly preferably greater than 4 N / 25 mm. Since the bandage does not adhere excessively to the wound site, the adhesive strength of the first adhesive layer is preferably no greater than 12 N / 25 mm. The adhesive strength of the first adhesive layer can be determined according to DIN EN ISO 29862:2019 (Method 1), with deviations from this standard allowed in the following areas: • Use polypropylene (PP) sheets instead of steel sheets as the substrate. PP sheets can be 150 mm x 50 mm x 4 mm in size and are formed as disposable specimens with the test side covered by foil. The foil is removed before testing. PP sheets can correspond to the steel sheets specified in the standard in terms of their surface quality. Correspondingly, PP sheets are therefore typically formed completely flat and have a smooth (test) surface. • The sample width is 25 mm instead of 24 mm. • The waiting time is 20 minutes, not less than 1 minute (that is, the sample is measured 20 minutes after it is applied to the PP plate). • In some cases, if the sample is too short, use extension tape (e.g., Tape Scotch 8959). • In some cases, if the sample is elastic, reinforced tape (e.g., Tape Tesa 4104) is used.

[0016] To determine the adhesive strength of the first adhesive layer, a tensile testing machine according to DIN EN ISO 7500-01:2018-06, category 1, can be used. The analysis of the measurement results can be performed according to DIN ISO 6133:2017-04 (Method B).

[0017] In addition, the thickness of the first adhesive layer can be from 20 µm to 60 µm.

[0018] For example, in the case of an island bandage, the (first) adhesive edge is used to secure the bandage to the wound site. This first adhesive edge is only positioned to be secured to the intact skin surrounding the wound. Accordingly, the first adhesive edge should not touch the wound. The first adhesive edge may, for example, have a width of 1.5 cm to 5 cm.

[0019] According to the present invention, the bandage also includes a wound liner. Depending on the intended use of the bandage, the wound liner can be designed in very different ways. Preferred features and variations of the wound liner are given in the following embodiments.

[0020] The wound pad is typically positioned substantially at the center of the bandage relative to the backing layer. Furthermore, the wound pad can be formed as a single layer or multiple layers. In particular, the wound pad comprises one or more layers selected from the group consisting of an absorbent layer, a pressure-dispersing layer, and a liquid-dispersing layer. The function and preferred design of these three different layers will be described below.

[0021] The absorbent layer can absorb and store fluids. That is, when the wound pad includes an absorbent layer, the bandage can absorb and store wound fluids. The absorbent layer is typically formed to be hydrophilic. For example, the absorbent layer can be composed of hydrophilic nonwoven fabric or hydrophilic foam material.

[0022] Preferably, the hydrophilic nonwoven fabric of the absorbent layer comprises alginate fibers, cellulose-based fibers, and / or superabsorbent polymers (SAPs) in fibrous form. The cellulose-based fibers can be cellulose fibers or viscose fibers. The superabsorbent polymer can, in particular, be polyacrylate. Polyacrylates can bind very large amounts of liquid and are therefore a particularly advantageous material for this absorbent layer.

[0023] The hydrophilic foam material of the absorbent layer is preferably an open-cell foam material. More preferably, the hydrophilic foam material of the absorbent layer is composed of polyvinyl alcohol or polyurethane.

[0024] In a preferred embodiment of the invention, the absorbent layer is composed of a hydrophilic nonwoven fabric, wherein the nonwoven fabric comprises cellulose-based fibers, particularly cellulose fibers or viscose fibers, and polyacrylate fibers. Alternatively, it is also preferred that the absorbent layer is composed of a hydrophilic, open-cell polyvinyl alcohol or polyurethane foam material.

[0025] The absorbent layer can also be further specified in terms of its absorption capacity. Thus, the absorbent layer can, for example, have a capacity of 50 g / 100 cm³. 2 Up to 300 g / 100 cm 2 50 g / 100 cm² is preferred. 2 Up to 250 g / 100 cm 2 More preferably 100 g / 100 cm2 Up to 250 g / 100 cm 2 And it is particularly preferred to have 140 g / 100 cm 2 Up to 220 g / 100 cm 2 The absorption capacity. Here, the absorption capacity of the absorption layer can be determined according to DIN EN 13726-1:2002-06 (Chapter 3.2).

[0026] In the sense of this invention, the pressure-dispersing layer disperses negative pressure within the bandage. When this layer is exposed to negative pressure, air and fluid can be drawn out from it. That is, when the wound pad includes a pressure-dispersing layer, the bandage is well-suited for negative pressure wound therapy. Preferably, the pressure-dispersing layer is formed to be hydrophobic. This pressure-dispersing layer can, for example, consist of spaced knitted fabric, textile, 3D-structured plastic foil, or hydrophobic, open-cell foam material.

[0027] The 3D-structured plastic foil of the pressure dispersion layer preferably has a large number of perforations, at least a portion of which forms protrusions. The 3D-structured plastic foil of the pressure dispersion layer can in particular be composed of polyethylene or polyurethane. Such plastic foils with a three-dimensional structure and both flat and rough sides are known from international patent application WO 2013 / 034263A1. The use of such pressure dispersion layers is also described in German patent application DE 102022133930.0.

[0028] The hydrophobic, open-cell foam material of the pressure dispersion layer is preferably composed of polyurethane. Therefore, in a preferred embodiment of the invention, the pressure dispersion layer is composed of a hydrophobic, open-cell polyurethane foam material. Suitable hydrophobic, open-cell polyurethane foam materials are disclosed, for example, in WO 2012 / 022485 A1.

[0029] Preferably, the pressure dispersion layer can have a density of 1000 l / (m²). 2 (sec) to 8500 l / (m 2 sec), preferably 1500 l / (m 2 (sec) to 6000 l / (m 2 sec), more preferably 2000 l / (m 2 sec) to 5000 l / (m 2 sec), with a preferred value of 2300 l / (m 2 sec) to 4000 l / (m 2 sec) and especially 2400 l / (m 2 sec) to 3300 l / (m 2The air permeability (sec) is specified. Here, the air permeability of this pressure dispersion layer can be determined according to DIN EN ISO 9237 (test thickness 20 mm, 20 cm). 2 The test area and 200 Pa differential pressure were determined.

[0030] As its name suggests, the liquid dispersion layer disperses liquids. Here, the liquid is dispersed primarily by means of capillary action within the layer. When the wound liner includes a liquid dispersion layer, the liquid within the wound liner (such as wound exudate) can be better dispersed, and the absorbent capacity of the absorbent layer contained within the wound liner can be better utilized. Therefore, it is particularly preferred that the wound liner includes an absorbent layer, and that a liquid dispersion layer is provided within the wound liner. The liquid dispersion layer is preferably formed to be hydrophilic. For example, the liquid dispersion layer can be composed of a hydrophilic nonwoven fabric. The hydrophilic nonwoven fabric preferably comprises cellulose-based fibers, especially cellulose fibers or viscose fibers.

[0031] In the present case, while the liquid dispersion layer can absorb and disperse the liquid, it can also release a small amount of liquid. However, superabsorbent polymers can bind liquids very strongly. Accordingly, the liquid dispersion layer advantageously does not include superabsorbent polymers, and in particular, does not include polyacrylates. Furthermore, when the wound liner comprises both an absorbent layer and a liquid dispersion layer, the liquid dispersion layer typically has a lower absorption capacity than the absorbent layer.

[0032] The liquid dispersion layer can have a concentration of 1 g / 100 cm⁻¹ 2 Up to 50 g / 100 cm 2 Preferred concentration: 1 g / 100 cm 2 Up to 40 g / 100 cm 2 More preferably 1 g / 100 cm 2 Up to 25 g / 100 cm 2 1 g / 100 cm² is a particularly preferred value. 2 Up to 10 g / 100 cm 2 And especially 1 g / 100 cm 2 Up to 7 g / 100 cm 2 The absorption capacity of the liquid dispersion layer can be determined according to DIN EN13726-1:2002-06 (Chapter 3.2).

[0033] Regarding the number and type of layers in the wound liner, the following variations are exemplarily suggested. In a simple single-layer embodiment of the invention, the wound liner consists of an absorbent layer. Thus, the bandage is particularly suitable for classic wound treatment, i.e., wound treatment without the use of negative pressure, especially for wounds with little to moderate exudation. In another simple single-layer design according to the invention, the wound liner consists of a pressure-dispersing layer. Thus, the bandage is particularly suitable for negative pressure wound therapy, wherein the wound fluid is collected in a container outside the bandage and the bandage therefore does not need to include an absorbent layer.

[0034] In an advantageous two-layer variant, the wound pad comprises an absorbent layer and a pressure-dispersing or liquid-dispersing layer. Here, the wound pad can be arranged in the bandage such that the absorbent layer is adjacent to the wound contact layer, and the pressure-dispersing or liquid-dispersing layer is adjacent to the backing layer or the first adhesive layer. In short, the pressure-dispersing or liquid-dispersing layer is positioned above the absorbent layer in the bandage. Alternatively, the wound pad can be arranged in the bandage such that the absorbent layer is adjacent to the backing layer or the first adhesive layer, and the pressure-dispersing or liquid-dispersing layer is adjacent to the wound contact layer. In short, the absorbent layer is positioned above the pressure-dispersing or liquid-dispersing layer in the bandage. Bandages with both absorbent and pressure-dispersing layers are particularly suitable for negative pressure wound therapy, where wound fluid is retained in the bandage and a small negative pressure source should be used without the need for a discharge collection container. Bandages with both absorbent and liquid-dispersing layers are particularly suitable for treating highly exudative wounds without the use of negative pressure.

[0035] In a particularly advantageous three-layer configuration, the wound liner may consist of an absorbent layer and two pressure-dispersing layers or two liquid-dispersing layers. Here, the absorbent layer is positioned between the two pressure-dispersing layers or the two liquid-dispersing layers. Similar to the previously described two-layer embodiment, the combination of an absorbent layer and two pressure-dispersing layers is particularly designed for negative pressure wound therapy in the absence of a secretion collection container, while the combination of an absorbent layer and two liquid-dispersing layers is particularly designed for treating highly exudative wounds in the absence of negative pressure. However, compared to the two-layer variant of this wound liner, the current three-layer embodiment still provides better dispersion of negative pressure or liquid within the bandage.

[0036] When the wound pad is constructed as a multilayer, these layers can be formed to be substantially the same size and stacked on top of each other. Here, these layers can be joined together across their entire surface, so that the wound pad is formed in a stacked manner. However, it may also be advantageous to design the wound pad as a bag. Correspondingly, one embodiment is proposed in which the wound pad includes a shell and an absorbent core located within the shell. The shell may consist of two nonwoven layers, wherein these nonwoven layers are joined together in their edge regions and thereby form a bag portion in which the absorbent core is received. These nonwoven layers are preferably joined by ultrasonic welding. The absorbent core particularly comprises cellulose and superabsorbent polymers in particulate form, particularly polyacrylate particles. Because the absorbent core is encapsulated, the SAP particles preferably loosely introduced into the cellulose cannot escape from the wound pad. In this respect, the shell ensures the structural maintenance of the wound pad. One or both of the aforementioned nonwoven layers of the shell may also preferably form a liquid dispersion layer in the sense of the present invention.

[0037] The silicone-coated wound contact layer of the bandage of the present invention is described in detail below. This wound contact layer is typically disposed substantially centrally relative to the backing layer in the bandage. Furthermore, the wound contact layer is generally formed to be substantially at least as large as the wound pad, thereby completely covering the wound-facing side of the wound pad.

[0038] In one embodiment of the invention, the wound contact layer and the wound liner are formed to be substantially the same size and terminate substantially flush. The wound liner having the wound contact layer can then be secured to the backing layer using a first adhesive layer. This embodiment is simple to manufacture and cost-effective.

[0039] Alternatively, the wound contact layer may extend beyond the wound liner, giving the wound contact layer an adhesive edge. In the present case, this adhesive edge of the wound contact layer is also referred to as a "second adhesive edge." This second adhesive edge is at least partially connected to the backing layer or the first adhesive layer, such that the backing layer and the wound contact layer can form a pocket for receiving the wound liner. In this embodiment, the wound contact layer can hold the wound liner within the bandage. It is possible that the backing layer is adhesively coated only in its edge areas to design the bandage as breathable. It is also possible that the wound liner consists of multiple layers loosely stacked on top of each other. This allows for highly variable multilayer wound liners in a simple manner in terms of their composition. The loosely stacked layers of the wound liner cannot be separated from each other because the backing layer and the wound contact layer surround the wound liner.

[0040] Additionally, the wound contact layer can form 30% to 90%, preferably 30% to 80%, more preferably 30% to 70%, and particularly preferably 50% to 70% of the side of the bandage facing the wound. The open area obtained through perforations in the wound contact layer can still be disregarded here. Furthermore, the carrier foil of the wound contact layer can be composed of polyurethane. The thickness of the carrier foil of the wound contact layer can, for example, be about 25 µm.

[0041] The silicone gel used for wound dressings is known to those skilled in the art, as well as acrylate adhesives, and is described in detail, for example, in EP 4 218 698 A1. The silicone gel of this wound contact layer has a lower adhesive strength than the acrylate adhesive disposed on the backing layer. Correspondingly, the adhesive strength of the second adhesive layer is preferably only 1.5 N / 25 mm to 2.7 N / 25 mm. The adhesive strength of this second adhesive layer can be determined according to FINAT No. 1 (FTM 1 peel tack at 300 mm / min (180°)). Deviations from this standard are permitted in the following areas: • Use Bristol cardboard instead of glass as the substrate. Bristol cardboard can be, for example, unperforated, single-color white Oxford paper, reference number 237000. • The atmosphere is controlled at 20 ± 2°C and 60 ± 5% relative humidity or 23 ± 2°C and 50 ± 5% relative humidity. • Measurements are performed within 20 minutes of sample preparation.

[0042] The thickness of the second adhesive layer can be from 80 µm to 200 µm, preferably from 100 µm to 150 µm.

[0043] The acrylic adhesive of the wound contact layer (according to the claim 3 adhesive layer) can be formed to be substantially the same as the acrylic adhesive (according to the claim 1 adhesive layer) disposed on the backing layer in terms of its adhesive strength and thickness. However, the third adhesive layer may also have different adhesive strength and thickness than the first adhesive layer. Preferably, the adhesive strength of the third adhesive layer is from 2 N / 25 mm to 7 N / 25 mm, especially about 4.5 N / 25 mm. The adhesive strength of the third adhesive layer can be determined according to FINAT No. 1 (FTM 1 peel tack (90°) at 300 mm / min). Deviations from this standard are allowed in the following points: • Use steel sheet instead of glass as the substrate. The steel sheet can be 50 mm x 150 mm (width x length) and is typically formed to be completely flat and smooth. • The atmosphere is controlled at 20 ± 2°C and 60 ± 5% relative humidity or 23 ± 2°C and 50 ± 5% relative humidity. • Measurements are performed directly after the sample is prepared.

[0044] The thickness of the third adhesive layer can be from 30 µm to 50 µm. In any case, the adhesive strength and thickness of the third adhesive layer can typically be selected such that the wound contact layer can be permanently secured to the wound liner and possibly also to the backing layer.

[0045] The contact layer of a perforated wound can have a density of 150 g / m². 2 Up to 200 g / m 2 The weight per unit area. Here, 70 g / m² 2 Up to 130 g / m 2 It can be a silicone gel.

[0046] As already explained, current bandages are specifically designed for negative pressure wound therapy. Advantageously, the bandage may also include, within the scope of negative pressure wound therapy, a suction tube for connection to a negative pressure source. This suction tube preferably has a connector at its wound-side end, the connector being configured to airtightly secure the wound-side end of the suction tube to the backing layer on the side opposite to the wound. Here, the connector is generally secured above an opening in the backing layer, thereby allowing the suction tube to be in fluid communication with the wound liner of the bandage. Connectors (also referred to as ports) for bandages used in negative pressure wound therapy are known to those skilled in the art. Such ports are disclosed, for example, in WO 2011 / 076340 A1 or WO 2017 / 097834A1. Furthermore, the suction tube advantageously has a portion of a plug connector or joint at its end remote from the wound, so that it can be easily connected to a negative pressure source or a secretion collection container. Such a connector with a closure is described in WO2017 / 097834 A1. Figure 1 An example is shown at the edge of the left side of figure a.

[0047] Additionally, when using this bandage in negative pressure wound therapy, it may be meaningful to include a filter that is impermeable to liquid but permeable to air. This filter can seal off the previously mentioned openings in the backing layer to prevent wound fluid from being absorbed from the bandage. This embodiment is particularly envisioned for constructing simple and compact negative pressure wound therapy systems where wound fluid in the bandage is absorbed by the absorbent layer and the negative pressure source does not have a secretion collection container.

[0048] Depending on the embodiment of the bandage, the filter can be arranged in different positions within the bandage. The filter is preferably directly connected to the backing layer and thereby closes the previously mentioned openings in the backing layer. When the bandage includes the connector described above, the filter can also alternatively be arranged within the connector. The filter is preferably a filter septum.

[0049] Apart from the first adhesive layer and the second adhesive layer, the bandage preferably does not include any other adhesive layers that come into contact with the patient's skin surface or wound surface.

[0050] As explicitly stated at the outset, this bandage is specifically designed or formed for wound treatment in the absence of separately provided adhesive strips for securing and / or sealing the bandage to the patient's body. Referring here are adhesive strips designed to be secured to the patient's skin surface and to the side of the backing layer opposite the wound. Normally, such adhesive strips, as an application system, consist of a one-sided adhesively coated plastic foil and optionally a peel-off foil.

[0051] Particularly preferably, the bandage is configured or formed for use in wound treatment without the need for separately providing a device for securing and / or sealing the bandage to the patient's body. Thus, in this preferred embodiment, any additional securing and sealing devices are excluded from the application associated with the bandage. Therefore, liquid sealants supplied in tubes or hydrogel strips known from EP 0 782 421 B1, which could be placed between the skin and the backing layer to compensate for unevenness, are excluded, for example, in addition to the adhesive strips mentioned above.

[0052] According to the present invention, the bandage includes at least the backing layer, the first adhesive layer, the wound liner, and the three-layer, perforated wound contact layer. Other components of the bandage may include the described suction tubing along with connectors and plug-in connectors, a filter, and a release foil. Correspondingly, current bandages may consist of the following components: i. The back layer ii. The first adhesive layer iii. The wound pad iv. A wound contact layer consisting of a perforated carrier foil, the second adhesive layer, and the third adhesive layer. v. Optionally, the peeling foil vi. Optionally, the filter vii. Optionally, the suction hose, preferably the suction hose, and the connector and / or plug-in connector.

[0053] The release foil covers the adhesive side of the bandage facing the wound. The release foil simplifies the handling of the bandage and protects it from contamination during storage. The release foil is removed by the user before the bandage is secured to the wound. The release foil can be formed in multiple pieces, such as two pieces. Application systems for self-adhesive wound dressings with such release foils are common and known to those skilled in the art.

[0054] The present invention also includes a kit for negative pressure wound therapy. The kit comprises a bandage as described above and a suction tube for connecting the bandage to a negative pressure source. The suction tube may be present separately from the bandage in the kit. Thus, the suction tube is not yet secured to the bandage at the manufacturer's location. Additionally, the suction tube in the kit may include connectors and / or plug-in connectors, as already mentioned. The kit is typically sterile and may also include, for example, a user guide. However, the kit preferably does not include adhesive strips for securing and / or sealing the bandage to the patient's body, provided separately from the bandage, and in particular, does not include devices for securing and / or sealing the bandage to the patient's body, provided separately from the bandage. Here, the term still refers to adhesive strips configured to be secured to the patient's skin surface and the side of the backing layer opposite the wound.

[0055] Another subject of the present invention is a system for negative pressure wound therapy. The system includes a bandage as described above, a negative pressure source, and a suction tube for connecting the bandage to the negative pressure source.

[0056] Finally, the present invention also relates to a method for wound treatment, comprising the following steps: i. Provide the bandages, kits, or systems described above. ii. Secure the bandage to the wound site, wherein preferably no separate adhesive strip for securing and / or sealing the bandage is provided throughout the wound treatment, and in particular no separate device for securing and / or sealing the bandage is provided.

[0057] In other words, the present invention also relates to the use of bandages, kits or systems as described above for treating wounds, particularly for treating wounds with negative pressure, wherein preferably no separate adhesive strip for securing and / or sealing the bandage is provided throughout the wound treatment, and in particular no separate means for securing and / or sealing the bandage is provided.

[0058] The bandage can be used in all of the above-described embodiments of the kit, system, and method. Therefore, additional features of the bandage in its particular embodiments are also disclosed in conjunction with the kit, system, and method. Attached Figure Description

[0059] The invention should be illustrated and demonstrated in detail by way of the illustrative drawings described below. Similar structural elements in the drawings may be referred to using the same reference numerals. Except... Figure 2 and Figure 5 In addition, the bandages are shown in side cross-sectional views.

[0060] Figure 1A bandage 1 according to the invention in a first embodiment is shown. The bandage 1 includes a backing layer 2. The backing layer 2 is preferably a transparent plastic foil, for example, composed of polyurethane, which is impermeable to liquids but permeable to water vapor. The backing layer 2 is coated entirely with an acrylic adhesive 3 on its wound-facing bottom surface. The acrylic adhesive 3 forms the first adhesive layer of the bandage 1 according to claim 1. The bandage 1 also includes a wound liner 4. Here, the wound liner consists of a single layer, preferably an absorbent layer. The wound liner 4 and the backing layer 2 are connected using the acrylic adhesive 3. Additionally, the bandage 1 includes a three-layer, perforated wound contact layer, which may be transparent like the adhesive backing layers 2 and 3. This wound contact layer consists of a carrier foil 5, which is adhesively coated on both sides. On its wound-facing bottom surface, the carrier foil 5 is coated with a silicone gel 6 (the second adhesive layer according to claim 1). On its wound-facing top surface, the carrier foil 5 is coated with an acrylic adhesive 7 (the third adhesive layer according to claim 2). The wound contact layer can be easily secured to the wound liner 4 using acrylic adhesive 7. The wound contact layer contains... Figure 1 Perforations, not shown, evenly penetrate all layers of the wound contact layer. These layers may be cut or punched into the wound contact layer, for example. Finally, the bandage 1 also includes a two-piece release foil 8 with gripping protrusions 9, 10. The release foil 8 protects the adhesive bottom surface of the bandage 1 and is removed before the bandage 1 is secured to the wound site.

[0061] like Figure 1 As shown, the adhesive backing layers 2 and 3 extend not only beyond the wound pad 4 but also beyond the wound contact layers 5, 6, and 7, such that the bandage 1 has an adhesive edge 11 (the first adhesive edge according to claim 1). The adhesive edge 11 is used to secure the bandage 1 at the wound location. The wound contact layers 5, 6, and 7 and the wound pad 4 are formed to be the same size in their planar extension and terminate flush at their edges. By centrally positioning the composite formed by the wound pad 4 and the wound contact layers 5, 6, and 7 on the adhesive backing layers 2 and 3, a typical design for an island bandage is obtained.

[0062] Figure 2 Shown from Figure 1 The bottom surface of the bandage 1 (without the peeling foil 8) is now visible. Perforations 12 in the wound contact layers 5, 6, and 7 are now visible. These perforations are arranged at regular intervals across the entire area of ​​the wound contact layers. The number, size, and shape of these perforations 12 should be understood exemplarily here. The perforations 12 can also be formed in a circular shape. By means of the combination according to the invention of a strongly adhesive acrylic adhesive 3 in the edge region 11 and a weakly adhesive silicone gel 6 in the central region contacting the wound, the bandage 1 can be firmly adhered to the wound location on the one hand, and can be removed again without damaging the wound surface on the other.

[0063] Figure 3 The bandage 13 of the present invention is shown in a second embodiment. The bandage 13 is from... Figure 1 and Figure 2 The bandage 1 is constructed similarly. However, unlike the previously shown variant, the bandage 13 has an opening 14 in the adhesive backing layers 2 and 3. A suction tube 15 with a connector 16 is secured directly to the non-adhesive outer or top surface of the backing layer 2, away from the wound, via the opening 14. In the illustrated case, the connector 16 comprises a hollow, dome-shaped housing 17 with a flange 18 formed as an adhesive, by which the connector can be secured to the backing layer 2 in a sealed manner against air and liquid. The suction tube 15 is then secured to the housing 17 in a fluid-conducting manner. The suction tube 15, together with the connector 16, is typically composed primarily of a substantially transparent flexible plastic (e.g., silicone or polyvinyl chloride (PVC)). Using the suction tube 15, the bandage 13 can be connected to a negative pressure source (not shown) and subsequently exposed to negative pressure.

[0064] In bandage 13, the wound pad 4 is not an absorbent layer, but advantageously can also be a pressure-dispersing layer, as previously explained. Bandage 13 may also have a release foil on the underside to protect its adhesiveness. However, for simplicity, the release foil is omitted in this figure and similarly in subsequent figures.

[0065] exist Figure 4 The third embodiment of the invention, as bandage 19, is shown in the image. Bandage 19 is from... Figure 1 and Figure 2 The difference in bandage 1 is that the wound contact layers 5, 6, and 7 extend beyond the wound pad 4. The wound contact layers 5, 6, and 7 therefore have an adhesive edge 20 (a second adhesive edge according to claim 2) that is at least partially connected to the adhesive backing layers 2 and 3. The adhesive backing layers 2 and 3 and the wound contact layers 5, 6, and 7 then form a pocket 21 for receiving the wound pad 4. In this embodiment, the wound pad 4 can be secured particularly well within the bandage. Figure 5 The bandage 19 is shown from a perspective of its bottom surface.

[0066] Figure 6 The bandage 22 of the present invention is shown in the fourth embodiment. The bandage 22 is derived from... Figure 4 and Figure 5 The bandage is based on bandage 19. However, additionally, the bandage has been prepared by... Figure 3 The known opening 14 and suction tubing with connectors 15 and 16 allow the bandage 22 to be used for negative pressure wound therapy.

[0067] exist Figure 7 The fifth embodiment of the bandage according to the present invention is shown with reference numeral 23 in the accompanying drawings. Bandage 23 is also derived from... Figure 4 and Figure 5 The bandage 19 is used as a base. However, unlike before, the wound pad 4 is here constructed as a multi-layered, i.e., two-layered structure. For example, the upper layer adjacent to the adhesive backing layers 2 and 3 of the wound pad 4 can be an absorbent layer. The lower layer adjacent to the wound contact layers 5, 6, and 7 can be a liquid dispersion layer. With this construction, the absorbent capacity of the absorbent layers can be better utilized because the liquid dispersion layer can disperse wound exudate that has passed through the wound contact layers 5, 6, and 7 across the entire surface of the absorbent layer.

[0068] Finally, Figure 8 The bandage 24 according to the invention is shown as a sixth embodiment. This corresponds to... Figure 7 The previously described variant differs in that the wound liner 4 consists of three layers. Advantageously, for example, the middle layer of the wound liner is an absorbent layer and the two outermost layers of the wound liner 4 are liquid dispersion layers. The absorbent layer is then incorporated between the two liquid dispersion layers in the wound liner 4. This results in a better distribution of wound exudate within the wound liner 4.

[0069] exist Figures 1 to 8 The bandages shown are all rectangular in shape. However, these bandages can also be designed to be circular, oval, or heart-shaped. A heart-shaped embodiment, for example, could be suitable for treating wounds in the sacral region. It is also proposed that the bandages according to the invention are provided not only in different shapes but also in different sizes. The availability of bandages of different shapes and sizes is a common practice in wound management, thereby allowing for the provision and selection of a suitable bandage for each wound, regardless of its location on the patient's body or its size.

Claims

1. A bandage for wound treatment (1, 13, 19, 22, 23, 24), comprising: - Back layer (2) - First adhesive layer (3), the first adhesive layer is disposed on the side of the back layer (2) facing the wound. - Wound padding (4). - Wound contact layer (5, 6, 7). The wound liner (4) is disposed between the backing layer (2) and the wound contact layer (5, 6, 7), and The back layer (2) having the first adhesive layer (3) extends beyond the wound pad (4) and also beyond the wound contact layer (5, 6, 7), such that the bandage has a first adhesive edge (11) consisting of the back layer (2) and the first adhesive layer (3). Its features are, - The first adhesive layer (3) is composed of an acrylic adhesive, and - The wound contact layer consists of a perforated carrier foil (5), a second adhesive layer (6) and a third adhesive layer (7), wherein the second adhesive layer (6) is disposed on the side of the carrier foil (5) facing the wound and is composed of silicone gel, and wherein the third adhesive layer (7) is disposed on the side of the carrier foil (5) away from the wound and is composed of acrylate adhesive.

2. The bandage according to claim 1, characterized in that, The back layer (2) has an opening (14) for evacuating air within the range of negative pressure wound therapy.

3. The bandage according to claim 1 or 2, characterized in that, The adhesive force of the first adhesive layer (3) is greater than 2.8 N / 25 mm, preferably greater than 3.5 N / 25 mm, and particularly preferably greater than 4 N / 25 mm.

4. The bandage according to any one of the preceding claims, characterized in that, The wound liner (4) comprises one or more layers selected from the group consisting of an absorbent layer, a pressure-dispersing layer, and a liquid-dispersing layer.

5. The bandage according to claim 4, characterized in that, The absorbent layer is composed of hydrophilic nonwoven fabric or hydrophilic foam material.

6. The bandage according to claim 5, characterized in that, The hydrophilic nonwoven fabric includes alginate fibers, cellulose-based fibers, and / or superabsorbent polymers in fibrous form.

7. The bandage according to any one of claims 4 to 6, characterized in that, - The absorbent layer is composed of a hydrophilic nonwoven fabric, wherein the nonwoven fabric comprises cellulose-based fibers, particularly cellulose fibers or viscose fibers, and polyacrylate fibers, or - The absorbent layer is composed of hydrophilic, open-cell polyvinyl alcohol or polyurethane foam material.

8. The bandage according to any one of claims 4 to 7, characterized in that, The absorbent layer has a concentration of 50 g / 100 cm⁻¹ 2 Up to 300 g / 100 cm 2 50 g / 100 cm² is preferred. 2 Up to 250 g / 100 cm 2 More preferably 100 g / 100 cm 2 Up to 250 g / 100cm 2 And it is particularly preferred to have 140 g / 100 cm 2 Up to 220 g / 100 cm 2 Absorption capacity.

9. The bandage according to any one of claims 4 to 8, characterized in that, The pressure-dispersing layer is composed of spaced knitted fabric, textile, 3D structured plastic foil, or hydrophobic, open-cell foam material.

10. The bandage according to any one of claims 4 to 9, characterized in that, The pressure dispersion layer has a density of 1000 l / (m 2 (sec) to 8500 l / (m 2 sec), preferably 1500 l / (m 2 (sec) to 6000 l / (m 2 sec), more preferably 2000 l / (m 2 sec) to 5000 l / (m 2 sec), with a preferred value of 2300 l / (m 2 (sec) to 4000 l / (m 2 sec) and especially 2400 l / (m 2 sec) to 3300 l / (m 2 The air permeability is sec.

11. The bandage according to any one of claims 4 to 10, characterized in that, The liquid dispersion layer is composed of a hydrophilic nonwoven fabric, wherein the hydrophilic nonwoven fabric preferably comprises cellulose-based fibers, especially cellulose fibers or viscose fibers.

12. The bandage according to any one of claims 4 to 11, characterized in that, The liquid dispersion layer does not include superabsorbent polymers and / or has a lower absorption capacity than the absorption layer.

13. The bandage according to any one of claims 4 to 12, characterized in that, The liquid dispersion layer has a concentration of 1 g / 100 cm⁻¹ 2 Up to 50 g / 100 cm 2 Preferred weight: 1 g / 100 cm 2 Up to 40 g / 100 cm 2 More preferably 1 g / 100 cm 2 Up to 25 g / 100cm 2 1 g / 100 cm² is a particularly preferred value. 2 Up to 10 g / 100 cm 2 And especially 1 g / 100 cm 2 Up to 7 g / 100 cm 2 Absorption capacity.

14. The bandage according to any one of claims 4 to 10, characterized in that, The wound liner (4) consists of an absorbent layer or a pressure-dispersing layer.

15. The bandage according to any one of claims 4 to 13, characterized in that, The wound pad (4) comprises an absorbent layer and a pressure-dispersing layer or a liquid-dispersing layer, wherein the wound pad (4) is arranged in the bandage as follows, such that - The absorbent layer is adjacent to the wound contact layer (5, 6, 7), and the pressure dispersion layer or the liquid dispersion layer is adjacent to the back layer (2), or - The absorbent layer is adjacent to the back layer (2), and the pressure dispersion layer or the liquid dispersion layer is adjacent to the wound contact layer (5, 6, 7).

16. The bandage according to any one of claims 4 to 13, characterized in that, The wound liner (4) consists of an absorbent layer and two pressure dispersion layers or two liquid dispersion layers, wherein the absorbent layer is disposed between the two pressure dispersion layers or the two liquid dispersion layers.

17. The bandage according to any one of the preceding claims, characterized in that, - The wound contact layers (5, 6, 7) and the wound liner (4) are formed to be substantially the same size and terminate substantially flush, or - The wound contact layer (5, 6, 7) extends beyond the wound liner (4) such that the wound contact layer (5, 6, 7) has a second adhesive edge (20), wherein the second adhesive edge (20) is at least partially connected to the back layer (2) such that the back layer (2) and the wound contact layer (5, 6, 7) can form a pocket (21) for receiving the wound liner (4).

18. The bandage according to any one of the preceding claims, characterized in that, The wound contact layer (5, 6, 7) forms 30% to 90%, preferably 30% to 80%, more preferably 30% to 70%, and particularly preferably 50% to 70% of the side of the bandage facing the wound.

19. The bandage according to any one of the preceding claims, characterized in that, The adhesive force of the second adhesive layer (6) is 1.5 N / 25 mm to 2.7 N / 25 mm.

20. The bandage according to any one of the preceding claims, characterized in that, Apart from the first adhesive layer (3) and the second adhesive layer (6), the bandage does not include any other adhesive layers that come into contact with the patient's skin surface or wound surface.

21. The bandage according to any one of the preceding claims, characterized in that, The bandage is configured for wound treatment without separately providing adhesive strips for securing and / or sealing the bandage to the patient's body, and especially without separately providing a device for securing and / or sealing the bandage to the patient's body.

22. A kit for negative pressure wound therapy, comprising: - The bandage according to any one of the preceding claims - A suction tube (15) for connecting the bandage to a negative pressure source, and - Optional use guide The kit preferably does not include adhesive strips for securing and / or sealing the bandage to the patient's body, and in particular does not include devices for securing and / or sealing the bandage to the patient's body.

23. A system for negative pressure wound therapy, comprising: - The bandage according to any one of claims 1 to 21, - Negative pressure source, and - A suction tube (15) for connecting the bandage to the negative pressure source.

24. A bandage, kit, or system according to any one of the preceding claims for treating a wound, wherein preferably no separate adhesive strip for securing and / or sealing the bandage is provided throughout the wound treatment, and in particular no separate means for securing and / or sealing the bandage is provided.

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