WOUND DEBRIDEMENT CLOTH

20230248385 · 2023-08-10

    Inventors

    Cpc classification

    International classification

    Abstract

    Wound cleaning device having a carrier layer and a wound cleaning layer arranged thereon, designed for holding wound exudate and/or solid wound components and having cleaning threads, the carrier layer and/or the wound cleaning layer being provided with at least one storage material that increases the capacity for holding wound exudate.

    Claims

    1. Wound cleaning device having a carrier layer and, arranged thereon, a wound cleaning layer designed to hold wound exudate and/or solid wound components and having cleaning threads, characterized in that the carrier layer and/or the wound cleaning layer is provided with at least one storage material that increases the holding capacity for wound exudate.

    2. Wound cleaning device according to claim 1, characterized in that the cleaning threads have plastic fibers, in particular polyester fibers, in particular consist thereof.

    3. Wound cleaning device according to claim 1 or claim 2, characterized in that the cleaning threads are designed as monofilaments and/or multifilaments.

    4. Wound cleaning device according to any one of the preceding claims, characterized in that the cleaning threads form loops and/or have freely cantilevered ends.

    5. Wound cleaning device according to any one of the preceding claims, characterized in that, based on the dry weight of carrier layer and cleaning layer, the proportion of at least one storage material is 0.1% 25% by weight, in particular 0.15%-20% by weight, preferably 0.2%-17% by weight.

    6. Wound cleaning device according to any one of the preceding claims, characterized in that, based on the dry weight of cleaning layer, the proportion of at least one storage material is 0.2%-30% by weight, in particular 0.25%-27% by weight, preferably 0.3%-25% by weight.

    7. Wound cleaning device according to one of the preceding claims, characterized in that at least the cleaning layer is impregnated using a preferably aqueous solution of the storage material.

    8. Wound cleaning device according to claim 7, characterized in that the concentration of the storage material in the solution is 0.1% or more, preferably 0.3% or more and/or 5% or less, in particular 2.5% or less, particularly preferred 1% or less.

    9. Wound cleaning device according to any one of the preceding claims, characterized in that the storage material has at least one surfactant and/or at least one substance that swells on contact with water or an aqueous solution.

    10. Wound cleaning device according to any one of the preceding claims, characterized in that the storage material contains at least one cellulose ether, in particular hydroxyethyl cellulose, carboxymethyl cellulose, methyl cellulose, ethyl cellulose and/or hydroxypropyl cellulose, additional polysaccharides, such as dextrans, starch, chitosan, carrageenan and alginates, milk protein, hyaluronic acid, sugar alcohols, glycols, salts and/or blends thereof.

    11. A process for producing a wound cleaning device according to any one of the preceding claims, in which at least the wound cleaning layer of the wound cleaning device is impregnated using a preferably aqueous solution of the storage material.

    12. Pack having a fluid impermeable sheath and a wound cleaning device according to any one of the preceding claims held therein.

    13. Kit for producing a wound cleaning device according to any one of the preceding claims, having a dry wound cleaning cloth and a preferably aqueous solution of at least one storage material.

    14. Use of a storage material for a wound cleaning device for wound bed preparation, wherein substances formed by the body itself, such as excess fluids, fibrin plaques, dead tissue of the epidermis, such as excess horn material or dead horn cells and/or plaques from dead tissue (necroses), are removed.

    Description

    [0023] FIG. 1 shows the “fluid holding capacity” of the wound cleaning devices obtained in this way in comparison to wound cleaning devices without any storage material merely premoistened using distilled water. The amount of exudate accommodated, based on the weight of the wound cleaning device, is given in percent.

    [0024] Additionally or alternatively, the wound cleaning device can be blended with a storage material solution obtained without any special temperature treatment and/or without using a crosslinking agent or can be placed into an appropriate solution. Within the scope of the invention, it is contemplated to first dry the wound cleaning device obtained in this way before use and not to remoisten it until used. This can, however, cause the cleaning threads to adhere to each other, thus impairing the cleaning effect. For this reason, within the scope of the invention, it has proven to be particularly advantageous if the wound cleaning device is available in the form of a pack having a fluid impermeable sheath and a wound cleaning device, such as a wound cleaning cloth, held therein. Adhesion of the cleaning threads to each other during transport and storage can thus be avoided.

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

    [0026] In this arrangement, a kit according to the invention can be made available in the form of a so called “click pack”, In this click pack, wound cleaning device and storage material solution are held in separate chambers. By creasing the pack at a specified location, a connection between the chambers can be produced and thereby impregnation of the wound cleaning device using the storage material solution can be brought about.

    [0027] Within the scope of the invention, the use of hydroxyethyl cellulose as a storage material has proven to be particularly expedient. This material is heat-resistant and is also suitable for sterilization processes using high temperatures. When using this storage material, it has proven to be particularly preferable to moisten the wound cleaning device using an aqueous solution of the storage material and subsequently to store it in a fluid impermeable sheath. Hydroxyethyl cellulose can be used in the form of an aqueous solution at a concentration range usually between 0.1% and 1.5%. Within the scope of the invention, it is particularly expedient to use hydroxyethyl cellulose solutions having concentrations between 0.1% and 5% for impregnating the wound cleaning device. At higher concentrations, the solution becomes very viscous and almost impossible to apply.

    [0028] Within the scope of this invention, independent protection is claimed for the use of a storage material for a wound cleaning device for wound bed preparation, in which substances formed by the body itself, such as excess fluids, fibrin plaques, dead epidermal tissue, such as excess horn material and/or dead horn cells and/or dead tissue plaques (necroses) are removed. Within the scope of the utilization according to the invention, use can also be made of anti-microbiological, disinfecting, wound healing-promoting, film forming, moisturizing and/or an acidic environment-creating properties of the storage material in connection with the wound cleaning device.

    [0029] When using hydroxyethyl cellulose as storage material, use can be made of the property of hydroxyethyl cellulose as a mucoadhesive polymer. This means that it bonds very well to mucous membranes. Because the surface condition of wounds and mucous membranes can be considered to be similar, hydroxyethyl cellulose adheres equally well to wound surfaces. As a result, appropriate film formation is promoted. The hydroxyethyl cellulose film prevents the wound from drying out and allows moisture to be retained in the wound, thereby promoting wound healing.

    [0030] In a wound cleaning device according to the invention, the cleaning threads may exist in pile form. In this arrangement, the pile mass, i.e. the mass of the cleaning layer, may be 1-10 g/100 cm.sup.2 of area. In this case, the cleaning layer may have monofilaments of polyester, which may have between 0.5 and 20 dtex. The threads may have threads projecting from the carrier layer, with freely cantilevered ends, while the shape of the threads may instead be curved. The length of the thread sections (pile height) available for wound cleaning outside the carrier layer may be 0.1 mm-50 mm, in particular 1 mm-40 mm, preferably 3 mm-30 mm, particularly preferred 4 mm-12 mm, such as approx. 5 mm or 10 mm. Neither do they need to project perpendicularly from the carrier layer. The carrier layer may feature a nonwoven, woven or knitted fabric. Alternatively or additionally, the carrier layer may instead be designed as a membrane or film, in which the cleaning threads are partially accommodated. With regard to the production of wound cleaning devices or cloths, which can be used within the scope of the invention, reference is made to WO 2010/085831 A1, which is included in this description by express reference in this regard, too.

    [0031] In addition or as an alternative to hydroxyethyl cellulose, wound cleaning devices according to the invention may, among others, be provided with the following storage materials, where storage material solutions can be used that are produced in a manner similar to that described for hydroxyethyl cellulose and where the wound cleaning device can be provided with the storage material by placing it in appropriate storage material solutions, by spray-on and/or by using a pipette:

    Additional Surfactants

    [0032] Poloxamers are block copolymers of ethylene oxide and propylene oxide. It is a debriding and antimicrobial surfactant. Poloxamer 188 attains increased heat stability (up to 260° C.) by propoxylation, which makes the substance compatible with common sterilization processes using heat. In addition to the increased heat stability, propoxylation can achieve preservation, anti oxidation, anti foaming and a viricidal effect. Optionally, butyl hydroxy toluene may be added. As additional surfactants, Tween 20/Tween-180, esterquats, sodium dodecyl sulfate, betaine, EHG (ethyl hexyl glycerol), carboxymethyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose can be used within the scope of the invention.

    Milk Protein

    [0033] For producing wound cleaning devices according to the invention, powdered milk (fat/protein/milk sugar) can, for example, be used. In this respect, milk protein also acts as an emulsifier.

    Acids

    [0034] Acids have antimicrobial properties. At a value of 4.5 to 5.5, the natural pH of the skin is situated in the slightly acidic range. The reason thereof is that a slightly acidic environment helps the skin kill pathogens from the outside. Within the scope of the invention, acetic acid, lactic acid, citric acid; formic acid and the like can be used for producing wound cleaning devices according to the invention.

    [0035] Hyaluronic acid is moisturizing; water bridges form (binding water), and the surface tension is reduced. Since the hyaluronic acid is significant for the exchange of information between the cells, it also has a positive effect in the wound healing process. It ensures that wounds heal without leaving any visible scars. This can be exploited within the scope of the invention herein.

    Sugar Alcohols

    [0036] Sugar alcohols, such as glycerol, have water binding properties. The water binding effect can be used for increased accommodation of wound exudate. When using sugar alcohols, in particular glycerol, an antimicrobial effect was observed, too.

    Glycols

    [0037] Within the scope of the invention, glycols, such as PEG 500/3000 (polyethylene glycol) can also be used for the production of wound cleaning devices according to the invention. PEG is water-soluble and highly hygroscopic. Within the scope of the invention, the ability to absorb water can be used to increase the capacity of wound cleaning devices. Additionally, PEG also has an antimicrobial effect.

    Salts

    [0038] Within the scope of the invention, use can be made of the odor absorbing, disinfecting and water binding effect of salts. In the scope of the invention, salts serve as a storage material. They may additionally have antimicrobial properties and neutralize the odor of wounds. Within the scope of the invention, Ringer's solution, consisting of sodium chloride, potassium chloride and calcium chloride, lactates (lactic acid salts and esters), sodium acetate (sodium salt of acetic acid), table salt and salts of acids, can be used as storage material. Blends of the storage materials discussed above can also be used.

    Palmitoyl Oligopeptide

    [0039] This storage material, a natural tripeptide, which is usable within the scope of the invention, has a biological effect in connection with the formation of new glycosaminoglycans and collagens and brings about increased hydration.