Wound cleaning cloth

Abstract

A wound cleaning device comprises a carrier layer and a wound cleaning layer arranged on the carrier layer for absorbing wound exudate and / or solid wound components and having a cleaning thread, wherein the carrier layer and / or the wound cleaning layer are provided with at least one storage substance that improves the absorption capacity of wound exudate.

Description

Technical Field

[0001] The invention relates to a wound cleaning cloth comprising a carrier layer and a wound cleaning layer arranged thereon for absorbing wound exudate and / or solid wound material, such as a fibrin coating, epidermal necrotic tissue, such as exuded keratinous material or dead keratinocytes and / or necrosis, and comprising a cleaning thread for removing wound components from the wound. Background Art

[0002] Such wound cleaning devices are described, for example, in WO 2010 / 085831 A1 and PCT / EP / 2019 / 073568. The disclosures in these documents concerning the properties of the carrier layer and the wound cleaning layer and the wire are hereby incorporated into this specification by explicit reference.

[0003] Wound cleaning cloths of the aforementioned type are used, for example, in so-called debridement. Debridement is the process of wound bed preparation, during which substances produced by the human body, i.e., body matter, such as exudate (wound exudate), the fibrin layer, and epidermal necrotic tissue, such as exuded keratin or dead keratinocytes and / or a layer of necrotic tissue (necrosis), are removed.

[0004] Known wound cleaning devices can separate the material to be removed from the wound by means of wires and fix it between the wires. However, a disadvantage of using known wound cleaning devices is that the material to be removed can be separated from the wound cleaning layer again during the wound cleaning process and return to the wound. Summary of the Invention

[0005] In view of these problems in the prior art, an object of the present invention is to provide a wound cleaning device with improved cleaning effect.

[0006] The solution of the present invention for achieving the above-mentioned object is an improvement of the known wound cleaning device, which is mainly characterized in that the carrier layer and / or the cleaning layer are provided with at least one storage substance that improves the absorption capacity of wound exudate.

[0007] The present invention is based on the recognition that a major drawback of using known wound cleansing devices is that their absorption capacity is reached during the wound cleansing process, and removed material subsequently re-enters the wound. The present invention eliminates this drawback by using a suitable storage material. Surprisingly, it has been shown that, despite the volume occupied by the storage material, the overall storage capacity can be increased. This is achieved by, on the one hand, better utilizing the available storage space of the wound cleansing device, and / or, on the other hand, by using the storage material to incorporate wound exudate into the wound cleansing layer and / or the carrier layer, thereby optimizing the overall storage capacity. This prevents wound exudate from smearing onto the surrounding skin, thereby reducing the risk of infection.

[0008] Within the scope of the present invention, the absorption capacity of a wound cleaning device for primarily liquid substances is described by the so-called "fluid holding capacity." To determine this "fluid holding capacity," the wound cleaning device is first weighed. The wound cleaning device is then exposed to wound exudate for 60 seconds. The wound cleaning device, soaked with wound exudate, is then gripped with tweezers and held in a vertical orientation for 30 seconds to allow the solution to drip off the wound cleaning device. The product is then placed vertically in a tray and reweighed. The weighing is used to determine how many milliliters of exudate are retained in the wound cleaning device per gram of wound cleaning device. This value represents the wound cleaning capacity within the meaning of the present invention. If this value increases due to the addition of a storage substance, this indicates, for the purposes of the present invention, an increased absorption capacity for wound exudate.

[0009] As with conventional wound cleaning devices, the wound cleaning threads of the wound cleaning device according to the present invention can comprise plastic fibers, in particular polyester fibers and / or polypropylene fibers, and in particular consist of polyester fibers and / or polypropylene fibers. The cleaning threads can be implemented as monofilaments, i.e., each thread consists of a single fiber, and / or as multifilaments, i.e., as a bundle of fibers twisted together as appropriate. In the present invention, these cleaning threads can form loops, wherein the threads emerge from a carrier layer and re-enter the carrier layer after the loop has been formed. Alternatively or in addition, the threads can have freely suspended ends, i.e., they emerge from the carrier layer and terminate freely.

[0010] According to a particularly advantageous embodiment of the present invention, the proportion of the storage material relative to the dry weight (total weight) of the carrier layer and the cleaning layer is 0.1-25 wt %, particularly 0.15-20 wt %, and preferably 0.2-17 wt %. A proportion of the storage material exceeding these values may cause adhesion of the cleaning line, thereby reducing storage capacity. A proportion of the storage material below these values may hardly produce the effect of the storage material.

[0011] It has been shown that storage material within the carrier layer can also enhance absorption capacity. Therefore, in advantageous embodiments, the amount of storage material is correlated with the total weight of the wound cleaning device. However, it is also important to ensure that the properties of the wound cleaning thread are not excessively affected by the storage material, and that the absorption capacity between cleaning threads is not significantly reduced by the storage material. From this perspective, it is advantageous for the storage material to comprise 0.2-30 wt %, particularly 0.25-27 wt %, and preferably 0.3-25 wt %, relative to the dry weight of the wound cleaning layer.

[0012] According to a particularly advantageous embodiment of the invention, at least the wound cleaning layer is impregnated with a preferably aqueous solution of the storage substance, thereby preventing the cleaning threads from sticking together due to dried storage substance.

[0013] To increase the storage capacity, the concentration of the storage substance in the solution used to impregnate the cleaning layer is advantageously 0.1% or more, preferably 0.3% or more and / or 5% or less, in particular 2.5% or less, particularly preferably 1.5% or less. The increased concentration causes the viscosity of the solution to increase. This can hinder the uniform distribution of the storage substance in the cleaning layer. If the concentration is too low, the available capacity of the cleaning layer is essentially filled with the impregnation liquid, leaving only a small amount of remaining capacity for wound exudate and other substances removed from the wound. The concentration here indicates the ratio of the weight of the storage substance to the weight of the solvent. When water is used as the solvent, a concentration of 0.1% means 1 g of storage substance per liter of solvent.

[0014] According to a particularly advantageous embodiment of the invention, the viscosity of the solution is set to 2000 mpas or less, in particular 1000 mpas or less, measured in accordance with DIN ISO 2555 using a Brookfield viscometer, model RTV.

[0015] The storage material used in the present invention may include at least one surfactant and / or at least one substance that swells upon contact with water or an aqueous solution. Surfactants, as used herein, refer to hydrophilic substances that allow hydrophobic substances to enter solution. Surfactants or emulsifiers reduce the energy (surface or interfacial tension) of phase boundaries, thereby inhibiting separation. The ability of surfactants or emulsifiers to mix incompatible liquids into a fine mixture and stabilize it promotes increased absorption of wound exudate during wound cleansing. The use of surfactants to reduce surface tension also facilitates the penetration of wound exudate into the gaps between wound cleansing lines, thereby improving overall absorption capacity.

[0016] When using substances that swell upon contact with water or aqueous solutions, the water is bound in the form of a gel. This increases the overall absorption capacity, since the bound water or wound exudate can no longer drip out of the cleansing layer.

[0017] The storage material applicable to the present invention may comprise at least one cellulose ether, in particular hydroxyethylcellulose; carboxymethylcellulose; methylcellulose; ethylcellulose and / or hydroxypropylcellulose; further polysaccharides, such as starch, polydextrose, chitosan, carrageenan and alginates; milk proteins; hyaluronic acid; sugar alcohols; glycols; salts and / or mixtures thereof.

[0018] Wound healing can be further promoted by incorporating anti-inflammatory and / or antibacterial substances, such as WO3 (tungsten (IV) oxide), into the wound cleaning layer and / or the carrier layer. The antibacterial effect of WO3 is due to the fact that tungsten oxide absorbs water, thereby forming H-rich +A thin layer of ions is formed, thereby destroying the bacterial membrane. Of course, other anti-inflammatory and / or antibacterial substances can be used as a supplement or alternative to WO3. The anti-inflammatory / antibacterial effects of the storage substance itself (such as hydroxyethyl cellulose) can also be utilized in the present invention.

[0019] According to the present invention, a solution of the storage substance, particularly an aqueous solution, is optionally sprayed onto the limiting surface of the wound cleansing layer facing away from the carrier layer using a spray bottle. Alternatively, the storage substance solution is introduced into the pad at equal intervals by pipetting. During this process, the cleaning layer is moistened starting from the fiber base facing the carrier layer. However, in a particularly advantageous embodiment of the present invention, the storage substance is introduced by dipping the wound cleansing layer into the corresponding solution. The procedure is as follows:

[0020] In one embodiment of the present invention, cellulose is used as the storage material. Cellulose is the most common polysaccharide found in nature and possesses many advantageous properties. These include biodegradability, biocompatibility, non-toxicity, low cost, and good thermal and chemical stability. Particularly advantageous in the present invention is the combination of high biocompatibility with non-toxicity and lack of immunogenic activity.

[0021] A storage substance, such as hydroxyethylcellulose (HEC), is added to distilled water until the desired storage substance concentration is achieved in the solution. The mixture is stirred continuously for one hour at an elevated temperature, for example, approximately 60°C, to obtain a homogeneous mixture. In an embodiment of the present invention, solutions with concentrations of 0.3% (3 g / L) HEC and 2.5% (25 g / L) HEC are prepared. When hydroxyethylcellulose is used as the storage substance, 0.5% citric acid is added as a crosslinking agent. Citric acid, when used as a crosslinking agent, produces a sponge-like, porous material. This property stems from the strong hydrogen bonds between the polymer chains. These strong interactions result in a very high capacity to absorb large amounts of water. The resulting structure can swell significantly without dissolving in aqueous solutions. The resulting solution is mixed at an elevated temperature, for example, approximately 60°C, for two hours to achieve crosslinking and poured into a glass dish without prior cooling. The wound cleansing device is then placed into the solution with the limiting side of the wound cleansing layer facing downward, thereby utilizing capillary action between the cleaning threads to ensure uniform absorption of the solution into the cleaning layer and / or the carrier layer, as appropriate.

[0022] In one embodiment of the invention, a polyester monofilament with a thread thickness of approximately 1 dtex (1 g / 10,000 m) and a pile height (see below) of 5 mm can be provided on the limiting side of the wound cleaning device facing away from the carrier layer. The mass of the cleaning thread (monofilament) can be 5 g / 100 cm 2 area. Figure 1The comparison of the "fluid holding capacity" of the wound cleansing device obtained in the above manner with a wound cleansing device pre-moistened with distilled water without a storage substance is shown in . The amount of exudate absorbed is given as a percentage relative to the weight of the wound cleansing device.

[0023] Additionally or alternatively, the wound cleaning device can be mixed with or placed into a storage substance solution which has been obtained without any special temperature treatment and / or without the use of a cross-linking agent.

[0024] According to the present invention, the wound cleaning device obtained in the above manner is dried before use and then re-moistened upon use. However, this may cause the cleaning threads to stick together, thereby affecting the cleaning effect. In view of this, according to a particularly advantageous embodiment of the present invention, the wound cleaning device is provided in the form of a package having a liquid-impermeable sheath and a wound cleaning device, such as a wound cleaning cloth, housed therein. This prevents the cleaning threads from sticking together during transportation and storage.

[0025] In an alternative embodiment of the present invention, a kit for producing a wound cleaning device or wound cleaning cloth according to the present invention is provided, comprising a dry wound cleaning device or dry wound cleaning cloth and a preferably aqueous solution of at least one storage substance. Before use of the wound cleaning device, the wound cleaning layer can be impregnated with the solution provided in the kit to obtain a cleaning layer and / or a carrier layer provided with the storage substance.

[0026] The kit of the present invention can be provided in the form of a so-called "click pack." In this click pack, the wound cleansing device and the storage substance solution are housed in separate chambers. By folding the packaging at a predetermined location, a connection is established between the chambers, allowing the wound cleansing device to be impregnated with the storage substance solution.

[0027] According to a particularly advantageous embodiment of the present invention, hydroxyethylcellulose is used as the storage material. This material is heat-resistant and also suitable for high-temperature sterilization processes. When using this storage material, it is particularly preferred to moisten the wound cleansing device with an aqueous solution of the storage material and then store it in a liquid-tight sheath. Hydroxyethylcellulose can be used as an aqueous solution with a concentration typically ranging from 0.1 to 1.5%. According to a particularly advantageous embodiment of the present invention, a hydroxyethylcellulose solution with a concentration of 0.1 to 5% is used to impregnate the wound cleansing device. At higher concentrations, the solution becomes very viscous and difficult to apply.

[0028] The claimed independent subject matter of the present invention is the use of a storage material in a wound cleaning device for wound bed preparation, wherein the wound bed is prepared by removing naturally occurring substances such as exudate, fibrin coating, and epidermal necrotic tissue, such as exuded keratin or dead keratinocytes and / or necrotic tissue coating (necrosis). In this application, the antimicrobial, disinfecting, wound healing promoting, film-forming, moisturizing, and / or acidic environment-creating properties of the storage material can also be utilized in conjunction with the wound cleaning device. When hydroxyethylcellulose is used as the storage material, its mucoadhesive polymer properties can be utilized. This means that it adheres well to mucous membranes. Since wounds and mucous membranes have similar surface properties, hydroxyethylcellulose adheres equally well to the wound surface, thereby promoting film formation. The hydroxyethylcellulose film prevents the wound from drying out or retains moisture within the wound, thereby promoting wound healing.

[0029] In the wound cleaning device of the present invention, the cleaning thread can be present as pile. The pile mass, that is, the mass of the cleaning layer, can be 1-10 g / 100 cm 2 area. In this case, the cleaning layer can comprise polyester monofilaments, which can have a dtex of 0.5 to 20 dtex. These wires can comprise wires extending from the carrier layer, the ends of which are freely suspended, wherein these wires can also have a curved course. The length of the wire segments outside the carrier layer for wound cleaning (pile height) can be 0.1-50 mm, in particular 1-40 mm, preferably 3-30 mm, particularly preferably 4-12 mm, such as 5 mm or 10 mm. These wire segments do not need to extend perpendicularly to the carrier layer. The carrier layer can comprise a fiber mesh, a woven fabric (woven fabric) or a knitted fabric. As an alternative or supplementary solution, the carrier layer can also be embodied as a membrane or film, in which the cleaning wires are partially accommodated. For the manufacture of wound cleaning devices or wound cleaning cloths that can be applied to the present invention, reference can be made to WO 2010 / 085831 A1, the relevant content of which is incorporated into this specification by explicit reference.

[0030] In addition to or as an alternative to hydroxyethylcellulose, the wound cleansing device according to the invention can also be provided with the following storage substances, wherein a storage substance solution can be used which is produced in a manner similar to that of hydroxyethylcellulose, and the wound cleansing device can be provided with the storage substance by introducing the corresponding storage substance solution, spraying and / or pipetting:

[0031] More surfactants

[0032] Poloxamer is a block copolymer composed of ethylene oxide and propylene oxide. It is an antimicrobial surfactant used in cleaning applications. Poloxamer 188 achieves higher heat resistance (up to 260°C) through propoxylation, making it compatible with common high-temperature sterilization methods. In addition to improving heat resistance, propoxylation also provides preservative, antioxidant, defoaming, and virucidal properties. Optionally, butylated hydroxytoluene (BHT) can be added. Polysorbate 20 / Polysorbate 180, esterquats, sodium lauryl sulfate, betaine, EHG (ethylhexylglycerin), carboxymethyl cellulose, methyl cellulose, ethyl cellulose, and hydroxypropyl cellulose can also be used as additional surfactants in the present invention.

[0033] milk protein

[0034] For example, milk powder (fat / protein / milk sugar) can be used to produce the wound cleaning device of the present invention. Milk protein is also used as an emulsifier.

[0035] acid

[0036] Acids have antibacterial properties. The skin's natural pH is 4.5 to 5.5, making it slightly acidic. This is because the slightly acidic environment helps the skin kill external pathogens. In the present invention, acetic acid, lactic acid, citric acid, formic acid, and the like can be used to manufacture the wound cleaning device of the present invention.

[0037] Hyaluronic acid has a moisturizing effect; it forms water bridges (water binding) and reduces O-type tension. Hyaluronic acid is crucial for intercellular communication and therefore also plays a positive role in wound healing. It ensures that wounds heal without leaving visible scars. The present invention can utilize this.

[0038] sugar alcohols

[0039] Sugar alcohols, such as glycerol, have water-binding properties. This hydration can be used to enhance the absorption of wound exudate. Sugar alcohols, particularly glycerol, can also have antimicrobial effects.

[0040] Ethylene glycol

[0041] In the present invention, ethylene glycol, such as PEG 500 / 3000 (polyethylene glycol), can also be used to manufacture the wound cleansing device of the present invention. PEG is water-soluble and highly hygroscopic. Its water absorption capacity can be utilized to increase the capacity of the wound cleansing device. PEG also has antibacterial properties.

[0042] Salt

[0043] In the present invention, the deodorizing, disinfecting, and water-binding properties of salt can be utilized. Salt is used as a storage material in the present invention. Salt can also have antimicrobial properties and neutralize wound odor. In the present invention, lactated Ringer's solution composed of sodium chloride, potassium chloride, and calcium chloride, lactates (salts and esters of lactic acid), sodium acetate (sodium salt of acetic acid), common salt, and acid salts can be used as a storage material. Mixtures of the aforementioned storage materials can also be used.

[0044] Palmitoyl oligopeptide

[0045] This storage substance, a natural tripeptide, which can be used in the present invention, has biological effects associated with the neoformation of glycosaminoglycans and collagen and causes increased hydrogenation.

Claims

1. A wound cleaning device comprising a carrier layer and a wound cleaning layer with cleaning threads arranged on the carrier layer, the wound cleaning layer being used to absorb wound exudate and / or solid wound components, the wound cleaning device being equipped with at least one storage substance for increasing the absorption capacity of wound exudate, characterized in that: The wound cleaning layer is provided with the storage substance, and the proportion of the at least one storage substance relative to the dry weight of the wound cleaning layer is 0.2-30 wt %.

2. The wound cleaning device according to claim 1, wherein The proportion of the at least one storage substance relative to the dry weight of the wound cleaning layer is 0.25-27 wt %.

3. The wound cleaning device according to claim 2, wherein: The proportion of the at least one storage substance relative to the dry weight of the wound cleaning layer is 0.3-25 wt %.

4. The wound cleaning device according to claim 1, characterized in that The cleaning thread comprises plastic fibers.

5. The wound cleaning device according to claim 4, characterized in that The cleaning thread comprises polyester fibers.

6. The wound cleaning device according to any one of claims 1 to 5, characterized in that The cleaning thread is embodied as a monofilament and / or a multifilament.

7. The wound cleaning device according to any one of claims 1 to 5, characterized in that The cleaning wire is formed into a loop and / or has a free hanging end.

8. The wound cleaning device according to any one of claims 1 to 5, characterized in that The proportion of the at least one storage substance relative to the dry weight of the carrier layer and the cleaning layer is 0.1-25 wt %.

9. The wound cleaning device according to claim 8, wherein The proportion of the at least one storage substance relative to the dry weight of the carrier layer and the cleaning layer is 0.15-20 wt %.

10. The wound cleaning device according to claim 9, wherein The proportion of the at least one storage substance relative to the dry weight of the carrier layer and the cleaning layer is 0.2-17 wt %.

11. The wound cleaning device according to any one of claims 1 to 5, characterized in that At least the cleaning layer is impregnated with a solution of the storage substance.

12. The wound cleaning device according to claim 11, characterized in that At least the cleaning layer is impregnated with an aqueous solution of the storage substance.

13. The wound cleaning device according to claim 11, characterized in that The concentration of the storage substance in the solution is 0.1% or more and / or 5% or less.

14. The wound cleaning device according to claim 13, characterized in that The concentration of the storage substance in the solution is 0.3% or more.

15. The wound cleaning device according to claim 13, characterized in that The concentration of the storage substance in the solution is 2.5% or less.

16. The wound cleaning device according to claim 15, characterized in that The concentration of the storage substance in the solution is 1% or less.

17. The wound cleaning device according to any one of claims 1 to 5, characterized in that The storage substance comprises at least one surfactant and / or at least one substance which swells upon contact with water or an aqueous solution.

18. The wound cleaning device according to any one of claims 1 to 5, characterized in that The storage substance comprises at least one cellulose ether.

19. The wound cleaning device according to claim 18, characterized in that The cellulose ether is hydroxyethyl cellulose, carboxymethyl cellulose, methyl cellulose, ethyl cellulose and / or hydroxypropyl cellulose.

20. The wound cleaning device according to claim 18, characterized in that The storage substance further comprises polysaccharides, milk proteins, hyaluronic acid, sugar alcohols, glycols and / or salts.

21. The wound cleaning device according to claim 20, characterized in that The polysaccharide is selected from the group consisting of polydextrose, starch, chitosan, carrageenan and alginate.

22. A method of manufacturing a wound cleaning device according to any one of claims 1 to 21, characterized in that At least the wound cleaning layer of the wound cleaning device is impregnated with the solution of the storage substance.

23. A package comprising a liquid-tight sheath and a wound cleaning device according to any one of claims 1 to 21 housed therein. 24 . A kit for producing a wound cleaning device according to claim 1 , comprising a dry wound cleaning cloth and a solution of at least one storage substance.

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