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    • 专利摘要:
    Wound cleaning device with a number of strand-like cleaning elements, characterized in that the cleaning quotient R = (E * F) / l of at least some cleaning elements is 0.05 N / mm or greater, in particular 0.1 N / mm or greater, preferably 1 N / mm or greater, particularly preferably 10 N / mm or greater and less than 1000 N / mm, preferably less than 500 N / mm, in particular 100 N / mm or less, where E denotes the modulus of elasticity of the material from which the cleaning elements are made, F denotes the mean cross-sectional area of the cleaning elements in a direction perpendicular to the strand axis and l denotes the effective length of the cleaning elements.
    公开号:AT16879U2
    申请号:TGM50086/2020U
    申请日:2019-09-04
    公开日:2020-11-15
    发明作者:
    申请人:Lohmann & Rauscher Gmbh；
    IPC主号:
    专利说明:

    description
    WOUND CLEANING DEVICE
    [0001] The invention relates to a wound cleaning device with a wound cleaning layer preferably having a number of strand-like cleaning elements. Such wound cleansing devices are specified in EP 2,365,794, for example. In the wound cleaning device described in this document, the strand-like cleaning elements are designed in the form of threads made of synthetic fibers, it also being possible for the threads to be in the form of monofilament fibers.
    With the known wound cleansing devices, the so-called debridement can be carried out particularly gently. Debridement is the process of wound bed preparation in which substances formed by the body itself, i.e. human material, such as excess fluids, fibrin coatings, dead tissue of the epidermis, such as excess corneal material or dead horny cells and / or coatings from dead tissue ( Necroses) are removed. The known wound cleaning device is designed as a wound cleaning cloth, the wound cleaning elements realized as threads protruding from a carrier layer. They form a pile in which the effective length of the threads between the carrier layer and the end of the threads facing away from the carrier layer, also known as the pile height, is between 3 and 30 mm and the threads have between 0.5 and 20 dtex.
    Although the known wound cleaning devices can be used with good success in the treatment of many wounds, in particular heavily exuding wounds, it has been shown that wound cleaning using the known wound cleaning devices causes problems in other cases.
    In view of these problems in the prior art, the invention is based on the object of providing a wound cleaning device for extended areas of application.
    According to the invention, this object is achieved by the further development of the known wound cleansing devices specified in claim 1.
    It has been shown that the only inadequate wound cleaning using the known wound cleaning devices can be attributed to the use of particularly soft and long fibers that ensure gentle wound bed preparation, but in many cases are not suitable for stubbornly adhering substances such as they occur in burn wounds, necrosis or some fibrin coverings, to be detached from the wound and / or taken up.
    In the context of the invention it was recognized that especially in the treatment of burns just mentioned, necrosis and stubborn fibrin coatings, a balanced compromise between satisfactory cleaning on the one hand and still acceptable mechanical stress on the wound can be found in the course of cleaning if the cleaning quotient in Range between 1 and 100 N / mm, preferably between 10 and 100 N / mm is set.
    In the context of the invention used cleaning elements may possibly have staple fibers made of synthetic fibers, especially monofilaments, if it is ensured that the cleaning quotient by increasing the cross-section of the monofilaments and / or shortening the effective length of the Monofilaments between 1 and 1000 N / mm is set. Additionally or alternatively, the wound cleansing device according to the invention can also have natural fibers, in particular in the form of staple fibers. In the context of this invention, cellulose fibers are addressed as natural fibers. If the cleaning elements form a pile similar to the known wound cleaning devices, the effective fiber length denotes the length of the fibers between their anchoring in a carrier layer and the ends of the fibers facing away from the carrier layer.
    If the cleaning elements designed as staple fibers, in particular monofilament fibers or multifilaments, form a cleaning fleece, the cohesion of the fleece results from the entanglement of the individual fibers, the fusing of the fibers at contact points, the needling of the fibers or the like. Between the entanglement areas, the An effective length of the staple fibers is available for cleaning at the contact points and / or the needling areas, whereby a desired cleaning effect can be achieved with an acceptable mechanical load on the wound by setting the effective length, the cross section of the fibers and the modulus of elasticity.
    According to the invention, at least some cleaning elements are designed in the form of loops extending from a carrier layer. In this case the effective length of the cleaning elements is defined as half the length of the loop, measured between the two points at which it emerges from the carrier layer. The effective length of the loops defined in this way can also be referred to as the pile height of a pile formed from these loops.
    In particular, in the case of loop-shaped cleaning elements, it has proven to be useful if at least some of these cleaning elements are designed as optionally twisted bundles of two, three or more monofilaments. The monofilaments of these cleaning elements can have a cleaning quotient of less than 0.05 N / mm if the cleaning quotient of the bundles formed by the monofilaments is greater than 0.05 N / mm. In the context of the invention, the term twisted denotes a structure in which the individual monofilaments revolve around a common helical axis. The loop-shaped cleaning elements can also be combined with other cleaning elements, for example with cleaning elements, which are designed to cantilever freely at their end facing away from a carrier layer.
    Damage to the individual cleaning elements still sufficiently preventing flexibility of the cleaning elements can be achieved if the fibers have a diameter of 500 μm or less, in particular 150 μm or less. On the other hand, detachment of individual fibers can still be prevented satisfactorily without excessive compression of the fleece if the diameter of the fibers is 10 μm or more, preferably more than 20 μm, in particular more than 30 μm or more, particularly preferably 45 μm or more. Excessive compression of the fleece is also viewed as problematic from the point of view that sufficient space must still be available in the cleaning device for the substances released from the wound. As explained in EP 2 365 794, these substances can also be retained in the cleaning device by electrostatic attraction when cleaning devices according to the invention are used.
    If the cleaning elements are designed in the form of an optionally twisted bundle of two, three or more monofilaments, the individual monofilaments of the bundle can also have a diameter of less than 10 μm. In this case too, however, it has proven to be advantageous if the thickness of the monofilaments forming the bundle is 5 μm or more in order to counteract the detachment of individual fibers from the bundle.
    In order to provide sufficient absorption capacity for impurities released from the wound, it has proven to be advantageous within the scope of the invention if the effective length of the fibers is 2 mm or more, preferably 3 mm or more, in particular 6 mm or more. The individual cleaning elements can be prevented from sticking together before the maximum absorption capacity for released impurities is used if the effective length of the staple fibers is 20 mm or less, in particular 15 mm or less, particularly preferably 13 mm or less, possibly 11 mm or less.
    It has proven to be particularly advantageous if the modulus of elasticity of the material of the staple fibers and / or continuous fibers is 135,000 N / mm®, in particular 100,000 N / mm or less, preferably 50,000 N / mm or less, particularly preferably 5000 N / mm or less and / or 100 N / mm or more, especially 250 N / mm or more, possibly 500 N / mm or more. When setting a larger modulus of elasticity, the fiber length must also be increased accordingly and / or the cross-sectional area must be reduced accordingly.
    which can lead to the problems already mentioned above. The lower limit for the modulus of elasticity results accordingly.
    In the context of the invention, the use of cleaning elements in the form of bristles and / or hooks and / or mushrooms protruding from a carrier web is also contemplated. For the reasons described in EP 2 365 794, it has also proven expedient within the scope of the invention to use plastic bristles and / or hooks and / or mushrooms as cleaning elements.
    When using cleaning elements in the form of bristles and / or hooks and / or mushrooms, the effective length denotes the height of the bristles or hooks or mushrooms in a direction perpendicular to the carrier web, while the cross-sectional area is the cross-sectional area in a parallel to the carrier web Section plane designated halfway up the mushrooms, hooks and / or bristles. In the case of mushroom-shaped or hook-shaped cleaning elements, the effective height thus designates the distance between the carrier web and a tangential plane running parallel to the carrier web at the apex of the hooks or mushrooms. This definition is based on the idea that the area of the hooks or mushrooms that is bent back on itself hardly affects the flexibility of the hooks or mushrooms as a whole.
    To provide sufficient absorption capacity for impurities released from the wound, it has proven to be useful if the effective length of the bristles and / or hooks and / or mushrooms is 10 mm or less, preferably 5 mm or less, in particular 3 mm or is less. Excessive stiffness of the bristles and / or hooks can be prevented if the effective length is 0.2 mm or more, in particular 0.5 mm or more, particularly preferably 1 mm or more.
    With regard to the desired absorption capacity and sufficient flexibility of the bristles and / or hooks and / or mushrooms, it has proven to be useful if the mean cross-sectional area of the bristles and / or hooks and / or mushrooms 10: 8 m or more and / or 10% m or less, preferably between 3 * 10 ° ® and 3 * 107 m®.
    The bristles, hooks or mushrooms can have a branch or fork on their side facing away from the carrier web, such that two or more ends arise on the side facing away from the carrier web of the bristles, mushrooms or hooks, which may be on themselves can be bent back.
    Again with a view to providing sufficient absorption capacity for contaminants on the one hand and ensuring a surface cleaning effect on the other hand, it has proven to be useful if more than 10, in particular 20 or more, particularly preferably 30 or more bristles and / or hooks and / or mushrooms per cm of the carrier web and / or fewer than 100, preferably 50 or fewer bristles and / or hooks and / or mushrooms per cm * of the carrier web are provided.
    The material of the bristles and / or hooks and / or mushrooms can have a modulus of elasticity of 135,000 N / mm or less, especially 50,000 N / mm or less, particularly preferably 5000 N / mm® or less and 100 N / mm or more, especially 250 N / mm or more, possibly 500 N / mm or more.
    In the context of the invention, it has proven to be particularly useful if at least some cleaning elements are at least partially, preferably completely, made of polyester, polyethylene, polypropylene, aramid, cellulose and / or a polyamide. To promote the cleaning effect, the invention also envisages applying an abrasive to the surface of at least one cleaning element. An aramid that can be used in the context of the invention has a modulus of elasticity of about 100,000 N / mm on. Polyethylene which can be used in the context of the invention can have a modulus of elasticity between 95,000 and 135,000 N / mm® *. Cellulose that can be used to produce wound cleansing devices according to the invention can have a modulus of elasticity between 3000 N / mm (Viscose) and 100,000 N / mm® (Flax) exhibit. Polypropylene staple fibers can have a modulus of elasticity of 5000 N / mm exhibit. Polyamide fibers can have a modulus of elasticity between 250
    N / mm and 3500 N / mm exhibit.
    Within the scope of the invention, the abrasive can have corundum, zirconium or aluminum oxide, silicon carbide, boron nitride, boron carbide, ceramic, chromium oxide, flint, quartz, emery, garnet, boron nitride, in particular cubic boron nitride and / or diamond. The abrasive can have a grain size in the range between 16 and 1200 mesh (according to DIN 69176), in particular between 150 and 800 mesh.
    According to the invention, the wound cleaning device has at least one wound cleaning layer designed to detach substances from a wound and to hold the detached substances, preferably a number of strand-shaped wound cleaning elements, this wound cleaning layer comprising two, three or more wound cleaning areas with differing wound cleaning properties can. The wound cleansing areas lie next to one another in strips.
    This aspect of the invention is based on the finding that the problems observed in the prior art in wound cleaning are also due to the fact that the requirements of wound cleaning can be met particularly well by geometrically separated areas if each individual area for a single wound cleaning process is optimized. This is particularly important in the treatment of burn wounds, necrosis and / or stubborn fibrin coatings, wherein wound cleaning devices according to the invention can also have wound cleaning areas with conventional wound cleaning elements. This can possibly promote the absorption of liquids and deposits.
    It has been shown that the geometric separation of individual wound cleansing areas with each optimized wound cleansing properties provides better overall wound cleansing results than the optimization of the wound cleansing area as a whole, as suggested in the prior art by proposing special fiber structures with the different requirements a single cleaning area can be met.
    According to the invention, one of the wound cleansing areas is an absorption area designed to absorb wound fluid, in particular serous wound fluid. This absorption area can be designed according to EP 2 365 794, i.e. it can have chemical fibers and / or natural fibers, in particular monofilaments and / or multifilaments made of plastic with an effective fiber length of 2 mm or more, preferably 3 mm or more, in particular 6 mm or more. In this case, however, the effective fiber length is preferably 15 mm or less, in particular 10 mm or less, because if longer fibers are used, no improvements can be achieved even in the absorption of serous substances with low viscosity. The substances released from the wound can be held between the individual fibers. In this way, renewed contamination of the wound by substances that had previously been removed can be prevented.
    According to the invention, one of the wound cleaning areas is an abrasion area designed to remove fibrin coverings, dead tissue, horn material or the like. At least one abrasion area can be arranged between two absorption areas. The abrasion area of wound cleansing devices according to the invention can also have synthetic fibers and / or natural fibers, in particular monofilaments and / or multifilaments, with an effective fiber length of 5 mm or less, preferably 3 mm or less, and / or the effective fiber length in an abrasion area arranged between two absorption areas can be 90 % or less, in particular 50% or less, particularly preferably 30% or less of the effective fiber length of the absorption region. The effective length of the fibers in the abrasion area is preferably 0.5 mm or more, in particular 1.5 mm or more and / or 5% or more, in particular 10% or more of the effective fiber length in adjacent absorption areas.
    Surprisingly, it has been shown that the shorter fibers of the abrasion area due to their greater rigidity not only the detachment of substances from the
    Favor the wound, but also improve the retention of these substances under special conditions. This surprising result is due to the fact that, particularly when viscous exudates / fibrin coatings are detached, adhesions occur in the area of the fiber tips, which make it impossible to use the entire volume available between the fibers of the absorption area. If shorter fibers are used, which promote the detachment of the substances from the wound, a lower degree of adhesion is observed in the area of the fiber tips, because the tips tend to stick together to a lesser extent due to the lower deflection, so that overall a larger one Absorption capacity between the fibers can be made available, even if the available volume is less than the total available absorption volume between the longer fibers. Furthermore, this can reduce the formation of cavities in the product in the form of unused fiber areas under the bonds on the product surface.
    In addition, when abrasion areas are arranged between absorption areas with greater fiber lengths, substances detached can also penetrate laterally into the absorption area in the area of the transition between abrasion area and absorption area.
    For the production of wound cleansing devices according to the invention, the known wound cleansing devices according to EP2 365 794 can be used as the starting product and abrasion areas can be produced in the desired patterns using a laser cutter and / or heating roller and / or by shearing / trimming the batt. When using a laser cutter, the fiber ends are melted. In this way, the abrasion properties can be further optimized. When using a heating roller, it is rolled over the product. This allows the cleaning elements to be melted. The cooling of the cleaning elements is also conceivable. The cleaning elements embrittled in this way can then simply be broken to produce the desired properties.
    If a wound cleaning device according to EP 2 365 794 is used as a starting product for the production of wound cleaning devices according to the invention, at least one abrasion area and at least one absorption area are arranged on a common carrier layer. In this case, the common carrier layer can be designed essentially flat, while the boundary surfaces of the absorption and abrasion areas facing away from the carrier layer form a profiled cleaning surface. Such wound cleaning devices are particularly useful for cleaning wounds with a large unevenness, such as large ulcers, because different levels of the wound base can be easily reached through the profiling on the boundary surface facing away from the carrier layer between the absorption and abrasion areas. In this way, effective wound cleansing can be achieved.
    [0033] Wound cleaning devices which consist exclusively of long fibers become heavy when moistened by the absorbed liquid and are thus unwieldy for wound cleaning. By using absorption areas with long fibers and abrasion areas with short fibers according to the invention, the weight is reduced and the dosage on the wound can be optimized because the wound bed can be better "felt through" and the wound bed levels can be cleaned evenly by adjusting the pressure to the respective area. As already mentioned, the capacity of the wound cleansing device can be better utilized because the longer fiber lengths can also be reached laterally (at the transition to the lower fiber areas) from the exudate / fibrin. On the other hand, the longer fibers reduce the hardness or stiffness of the product, which in turn contributes to less mechanical stress on the wound and the wound environment.
    In addition, so-called mixed wounds (in wounds there are usually several viscosities) can be effectively treated, because, as already explained above, each individual fiber length of the cleaning layer has a different optimal functional area in terms of effectiveness and mechanical capacity, the short fiber harder / fibrin-like deposits and / or liquids with high viscosity or very viscous substances that last for a long time
    Fiber for serous exudate (low viscosities). This means that several functional areas can be combined in one product. It is also to be expected that hard lumps can be held well in the alternating product fiber structure. With wound cleansing layers made of fibers of the same length, solid lumps tend to "pear off".
    In another embodiment of the invention, the carrier layer can be profiled and the boundary surfaces of the absorption and abrasion regions facing away from the carrier layer can be arranged approximately in a common plane. In this embodiment of the invention, it is particularly advantageous that the longer fibers of the absorption layer can hardly lie over the shorter fibers of the abrasion layer, because they are held in place by the profiling of the carrier layer. In this way, abrasion and absorption properties can be retained even when the pressure on the wound cleaning device occurs during wound cleaning. Such wound cleansing devices can be used with particular advantage when harder substances or coatings, in particular fibrin coatings and / or necroses, have to be removed from an otherwise serously exuding wound. In addition or as an alternative to the profiling of the carrier layer, the carrier layer can also have continuous cutting lines, so that the areas of the wound cleaning layer arranged on both sides of the cutting lines can be adapted independently of one another to the profile of the surface to be cleaned, such as the wound surface or the area surrounding the wound. In this case, fibers of the same length can be used in the cleaning layer on both sides of the cutting line.
    With wound cleaning devices according to the invention, not only the wound itself, but also the skin surrounding the wound can be cleaned. Not only human material can be removed. In addition or as an alternative to the removal of human material, foreign material can also be removed from the area of the wound and / or the skin surrounding the wound using wound cleaning devices according to the invention. Examples of foreign material include residues from ointments, such as zinc ointment, residues from plasters or wound coverings, substances formed from human material by adding water and / or aqueous or non-aqueous solutions, and the like.
    In the embodiments explained above, the abrasion area is formed by fibers of shorter length. In addition, an abrasion area can also be formed by a seam running between two absorption areas. The fibers of the absorption area are optionally fixed to a carrier layer by the seam and thus form an area of greater rigidity overall, which promotes the detachment of substances from the wound. Additionally or alternatively, an abrasion area can also be embodied by an abrasive fleece made of strand-like cleaning elements with a greater modulus of elasticity than the fibers of the absorption area and / or formed by an abrasive film with abrasive abrasive grains.
    In wound cleansing devices according to the invention, the abrasion areas can form a line, grid and / or network structure that separates the absorption areas from one another. The distance between two absorption areas separated from one another by an abrasion area is 10% or more, preferably 30% or more, in particular 50% or more and / or 150% or less, in particular 100% or less, particularly preferably 90% or less of the effective Fiber length of the fibers of the absorption area. The absorption areas, like the abrasion areas, can be related. For example, you can run around in a spiral. The distance between two absorption areas separated from one another by an abrasion area can be 30 mm or less, in particular 10 mm or less, optionally 5 mm or less and / or 0.1 mm or more, preferably 1 mm or more, in particular 3 mm or more .
    As already explained above, wound cleansing devices with wound cleansing layers made of fibers with a small fiber length are particularly well suited for removing viscous liquids from wounds.
    [0040] Within the scope of the invention, the provision of a wound cleaning kit with a wound cleaning device according to the invention accommodated in a sterile pack is also important.
    thought. In and / or on the pack, instructions for using the wound cleaning device in the treatment of burn wounds and / or necrosis and / or stubborn fibrin coverings and / or exuding wounds and / or fibrinous coverings can be provided.
    As can be seen from the above explanation of wound cleansing devices and wound cleansing kits according to the invention, a wound cleansing device according to the invention is used with particular advantage for producing a therapy arrangement for the treatment of burns, necrosis and / or fibrin coatings. The wound cleaning device according to the invention is suitable for use in the treatment of burn wounds, necrosis and / or fibrin coverings and / or exuding wounds.
    With regard to the properties of the natural fibers and / or man-made fibers suitable for the production of wound cleansing devices according to the invention, reference is made to EP 2 365 794. Thereafter, the wound cleansing devices according to the invention can be used, that is, both to manufacture the abrasion areas and to manufacture the absorption areas Fibers have an effective length between 3 and 30 mm. The fibers can have between 0.5 and 30 dtex.
    [0043] The abrasion areas of wound cleaning devices according to the invention can form a square pattern. The distance between adjacent absorption areas is defined as the edge length of the squares. You can also revolve in a spiral. They can form wavy lines. It is also thought of abrasion areas radiating from a common center. It is also possible to design the abrasion areas in the form of serrated lines between individual absorption areas. If the abrasion areas are formed by seam lines, the distance between the individual seam lines can be between 20 and 90% of the effective fiber length in the absorption areas. In a preferred embodiment, the distance between the seam lines can be approximately 0.5 to 3 cm, in particular approximately 0.7 cm. In another embodiment of the invention, the distance between the individual seam lines can be about 1 cm. When treating large wounds with appropriately sized wound cleansing layers, the distance between the suture lines can be 2 to 3 cm.
    The width of abrasion areas arranged in strips between absorption areas, which can be obtained, for example, by processing a starting product according to EP 2 365 794 using a laser cutter and / or a heating roller, is preferably between 0.2 and 0.9 cm, in particular about 0 , 5 cm. Continuous dividing lines at intervals of 0.2 to about 1 cm can also be introduced into a corresponding starting product by means of a laser cutter. If an abrasive fleece or an abrasive film is used as the abrasion area, corresponding abrasion areas can also be arranged in strips extending longitudinally between individual absorption areas, the width of the individual abrasion areas being about 0.5 to 1.5 cm, preferably about 1 cm. In the case of wound cleansing facilities with a larger area, abrasion areas with a greater width of up to 5 cm can also be used. In all embodiments of the invention, the abrasion areas can also be produced by cooling or “freezing” and then breaking the corresponding cleaning elements.
    If the wound cleaning device according to the invention has only one cleaning layer with a cleaning area made of fibers with a fiber length of 5 mm or less and 1.5 mm or more, viscous liquids can thus be detached from the wound and retained particularly well. If both fibers with a short effective length and fibers with a comparatively large effective length are used, it has proven to be advantageous if the proportion of fibers with a short length between 10 and 90%, preferably between 30 and 70%, is particularly preferred about 50% of the total number of fibers. The fibers forming the cleaning layer of wound cleaning devices according to the invention can at least partially, preferably completely, consist of polyester, nylon, polyethylene, polypropylene, aramid, cellulose and / or polyamide. On the surface of each
    Fibers can also be applied abrasives as an additional cleaning agent.
    According to a further aspect of the invention, at least some cleaning elements or wound cleaning elements can be at least partially equipped with an antimicrobial coating.
    Such wound cleaning devices are described, for example, in WO 2010/085831 A1. In these known wound cleansing devices, the wound cleansing elements are in the form of individual plastic fibers or monofilaments made of polyester which protrude from a carrier layer and have freely cantilevered ends on their side facing away from the carrier layer. The freely protruding ends create a razor-blade effect that favors wound cleaning without impairing the wound healing process.
    When using the known wound cleaning devices, thought is also given to eliminating bacterial colonization of the wound with a biofilm, which leads to systematic infection in the patient. For this purpose, the wound cleaning elements made of plastic fibers can also be equipped with an antimicrobial coating in the known wound cleaning devices.
    When using the known wound cleaning devices, however, it has been shown that in many cases the wound is still infected despite careful wound cleaning and the use of an antimicrobial coating.
    In the context of this invention, these problems are solved by a further development of the known wound cleansing devices, which is essentially characterized in that the antimicrobial coating has two metals which differ from one another and are preferably present as bi-metal particles.
    The invention is based on the finding that conventional coatings hardly develop their antimicrobial effect when cleaning wounds. When cleaning wounds with wound cleaning devices according to the invention, the wound is wiped out using the wound cleaning elements. The contact time between wound cleansing elements and wound bed or bacterial colonization of the wound or the duration of action is at most a few seconds. On the other hand, the mechanism of action of conventional antimicrobial coatings, for example based on silver, is based on the fact that metal or silver ions are released and develop their oligodynamic effect. However, the release of the metal or silver ions takes place with a long delay, so that the antimicrobial effect does not or hardly starts with a contact time of only a few seconds.
    On the other hand, coatings with antimicrobial substances in the form of large molecules, such as PHMB, only have a reduced depth of penetration into the wound bed, which is also insufficient for the desired antimicrobial effect.
    This aspect of the invention is based on the surprising finding that the antimicrobial effect when using coatings with two metals which differ from one another and which are preferably present as bi-metal particles, unlike in EP 2 077 976 B1, is not assumed Release of metal ions is based, but rather on a catalytic effect, with the help of which antimicrobial substances, in particular reactive oxygen species (ROS = Reactive Oxygene Species), such as hydrogen peroxide, are generated on contact with aqueous media. The catalytic generation of the antimicrobial substances using a coating containing two metal species takes place on contact with aqueous media on a time scale of significantly less than one second. Therefore, when wiping a wound with wound cleansing devices designed according to this aspect, with appropriate contact times between wound cleansing elements and wound bed, sufficient catalytic conversion to antimicrobially effective products occurs. Furthermore, the antimicrobially active products produced in this way in the form of ROS are comparatively small molecules which have a sufficient depth of penetration into the wound bed. Overall, bacterial colonization of the wound bed can thus be countered in a satisfactory manner using wound cleaning devices according to the invention.
    If the metal species are in the form of bi-metal particles, a contact potential is formed with which the catalytic effect of the metal species can be further promoted. Another advantage of the antimicrobial coating used according to the invention is that the coating is not used up because the antimicrobial effect is not based on the release of metal ions, but on a catalytic effect. Therefore, there may be a continuous formation of relatively short-lived reactive substances, especially ROS. The antimicrobial effect is therefore retained even with repeated use, such as wiping the same wound several times with one and the same wound cleaning element.
    In the context of the invention, it has proven to be particularly advantageous if the antimicrobial coating contains silver and / or ruthenium. The antimicrobial effect of silver ruthenium coatings is described, for example, in EP 2 077 976 B1. The mechanism of action assumed there (release of silver ions) does not play a role in the application of corresponding coatings in connection with wound cleansing devices. Surprisingly, it has been shown that silver-ruthenium coatings promote the catalytic conversion of aqueous media to reactive oxygen species, which can have antimicrobial effects. Only then has the use of this coating in connection with wound cleaning by wiping off wounds made sense.
    Surprisingly, the catalytic effect is favored if the antimicrobial coating has a vitamin and / or a vitamin derivative, the vitamin preferably being ascorbic acid.
    The thickness of the antimicrobial coating on the cleaning elements is preferably less than 1 µm, in particular 800 nm or less. This ensures that even when using fine fibers there is no significant change in the mechanical fiber properties due to the coating. To ensure the effectiveness of the coating, it has proven to be useful if the thickness of the coating is 100 nm or more, in particular 200 nm or more. The coating is expediently applied to the wound cleansing elements by means of PVD (physical vapor disposition) techniques.
    Additionally or alternatively, the antimicrobial coating can also have a surface-active substance. As with the wound cleansing devices described in WO 2010/085831 A1, the wound cleansing elements of a wound cleansing device according to the invention can protrude from a carrier layer, wherein at least some of the wound cleansing elements can preferably have freely protruding ends on their side facing away from the carrier layer.
    As can be seen from the above explanation of wound cleansing devices according to the invention, these are used with particular advantage in debridement. The term debridement is understood to mean the preparation of the wound bed, in which substances or human material formed by the body itself, such as excess fluid, fibrin coatings, dead tissue of the epidermis, such as excess horn material, or dead horn cells and / or coatings from dead tissue (Necroses) are removed.
    The invention is not limited to the use of silver-ruthenium-containing coatings. Rather, the use of coatings with platinum-ruthenium, ruthenium-copper and / or ruthenium-gold nanoparticles is also considered.
    In the context of the invention, the wound cleansing device according to the invention can be provided in the form of a kit in which the wound cleansing device is received in a sterile pack. In and / or on the pack, instructions for using the wound cleaning device in the treatment of burn wounds, necrosis and / or stubborn fibrin coatings and / or biofilms and / or bacterial contamination can be provided.
    As can be seen from the above explanation of wound cleaning devices and kits according to the invention, the invention also relates to the use of a wound cleaning device according to the invention for producing a therapy arrangement for treatment
    of burns, necrosis and / or fibrin coatings. For this purpose, the wound cleaning device according to the invention can also be attached to a preferably flexible application rod. The application rod can optionally also be equipped with a wound cleaning device according to the invention on both sides. In other embodiments of the invention, the wound cleaning device can also be designed as a modular system with a cleaning head that can optionally be detachably fastened to an application rod, the cleaning head having a wound cleaning device according to the invention. Furthermore, a wound cleaning device according to the invention can also be designed in the form of a glove.
    The invention also contemplates the use of wound cleaning devices with two, three or more cleaning areas, one of the cleaning areas being able to have cleaning elements in the form of hooks, bristles and / or mushrooms and another cleaning area with fibrous or thread-like cleaning elements can be equipped. The cleaning quotient of the threads and / or fibers can be less than 0.05 N / mm.
    In the context of this invention it has surprisingly been shown that wound cleaning devices according to the invention can be used not only for wound cleaning itself, but also for subsequent wound care using a suitable wound dressing, in particular in the context of so-called negative pressure or vacuum therapy.
    In negative pressure therapy, negative pressure is generated in the wound space. For this purpose, the wound space is usually lined with a possibly absorbent filler material which not only serves to absorb wound exudate, but also to distribute the negative pressure evenly over the entire wound surface. The wound or the filling material is covered with a suitable covering device, such as a film. In this case, an airtight covering device can be used which, however, can be designed to be water vapor permeable in order to prevent excessive drying out of the wound and maceration in the area of the wound edges.
    The wound space closed with the aid of the cover device and containing the wound filling material is usually connected to a vacuum source, such as a pump, by means of a drainage tube. The negative pressure or suction applied to the wound space via the pump and hose promotes active wound cleaning by removing excess wound exudate, cell debris and bacteria from the wound. Furthermore, wound edema is reduced and the blood flow situation in the wound area is improved. In addition, the formation of granulation tissue is accelerated. It is assumed that the acceleration of the formation of the granulation tissue is due to the fact that the tissue is stimulated to increased cell proliferation, angiogenesis and the formation of tissue matrix by the negative pressure and the associated expansion of the cells.
    In the course of the negative pressure therapy or at the end of the negative pressure therapy, the covering device and the filling material are removed from the wound. It has been shown that with conventional negative pressure therapy arrangements, only unsatisfactory wound healing is observed in many cases.
    The problems of wound healing are solved in the context of negative pressure therapy by providing a wound dressing with a number of strand-shaped wound contact elements having wound contact layer and a preferably airtight, but in particular water vapor permeable cover device which can be adhered to the skin surrounding the wound. This point of view is based on the knowledge that the problems observed with conventional negative pressure therapy can be attributed on the one hand to the fact that when a conventional wound sponge is used as the wound filling material, the tissue grows around and into the three-dimensional sponge structure. When the dressing is changed, the connecting webs in the sponge structure only yield to a limited extent and the tissue can be injured again when the wound dressing is removed.
    This deficiency is remedied by using the wound contact layer with a number of stranded
    shaped wound contact elements, which can be formed for example by a wound cleaning device according to the invention, solved. The healing tissue can grow between the individual wound contact elements, but is not injured when the dressing is changed, because the many wound contact elements are pulled out of the healing wound surface individually and without hindrance from other wound contact elements. For the production of a wound dressing according to the invention, not only cleaning devices according to the invention but also wound cleaning devices known from EP 2365794, for example, can be used. It is essential that the wound contact layer is formed by a large number of individual wound contact elements, between which there is enough space for the healing tissue to grow in, the individual volume segments of this space being open on their side facing the wound and the detachment of the wound contact elements from the possibly ingrown tissue enable.
    In addition, the use of wound contact layers with a number of possibly strand-shaped wound contact elements also contributes to the formation of a granulation lawn that promotes wound healing. The individual wound contact elements can also promote accelerated wound healing through mechanical stimulation of the wound tissue. The tissue is stimulated to increase proliferation through so-called "micro needling". The movement of the individual wound contact elements can cause mechanical stimulation of the tissue and thus increased cell proliferation. The mechanical movement can be generated, for example, by an external mechanical energy supply, the patient's own movement, an excited piezo crystal, ultrasound and / or by intermittent negative pressure.
    In addition, the wound healing-promoting effect of the wound dressings with a number of strand-shaped wound contact elements can also be attributed to the fact that the wound contact elements promote deep cleansing of the wound during use and possibly promoted by the relative movements between the wound contact elements and the wound surface in a mobile patient . In addition, an assisted absorption and an improved removal of the exudate is observed if the dressing has hydrophilic fibers.
    A bandage can be implemented as a finished bandage with integrated wound contact elements, which are optionally provided by a wound cleaning device according to the invention. It is also contemplated, however, to combine a wound cleaning device according to the invention and a conventional wound dressing to form a kit, the wound cleaning device being enclosed with the conventional wound dressing for optional wound filling.
    The wound dressing can have an absorption and / or distribution layer arranged between the wound contact layer and the covering device. The covering device of a bandage according to the invention can be provided in the form of a film, such as a polyurethane film.
    As can be seen from the above explanation of negative pressure therapy arrangements, it has also proven to be expedient if the cover device is assigned a connection device which is designed to connect a fluid line connecting the wound space to a negative pressure source.
    The only figure in the drawing shows a wound dressing according to the invention. This wound dressing comprises a wound cleaning device 20 according to the invention and a cover device 30 in the form of a backing film which is permeable to water vapor and which can be designed as a polyurethane film. The wound cleaning device 20 has a large number of wound cleaning elements on its side facing the wound, which are used as wound contact elements 22 in the context of a wound dressing according to the invention. The wound contact elements 22 are only shown schematically in the drawing. They can be realized in the form of a fiber fleece or the like. The wound contact elements 22 can also be implemented in the form of individual loops, hooks, bristles and / or mushrooms. Mixtures of fibers, loops, bristles, hooks and / or mushrooms can also be used.
    Between the wound cleansing device 20 and the covering device 30, a distribution layer 42 and an absorption layer 44, optionally designed as an airlaid, are provided. In this case, the distribution layer 42 is arranged on the side of the absorption layer 44 facing the wound cleaning device 20.
    权利要求:
    Claims (24)
    [1]
    1. Wound cleaning device with a wound cleaning layer, for detaching substances from a wound and for holding the substances in place, and with a number of strand-like cleaning elements, the cleaning quotient R = (E * F) / I of 5% or more of the cleaning elements 0.1 N / mm or greater, and 100 N / mm or less, where E denotes the modulus of elasticity of the material from which the cleaning elements are made, F the mean cross-sectional area of the cleaning elements in a direction perpendicular to the strand axis and | denotes the effective length of the cleaning elements, the cleaning elements having synthetic fibers and / or natural fibers, characterized in that the cleaning elements form loops starting from a carrier layer, the effective length being defined as half the length of the loop, measured between the two points, at which it emerges from the carrier layer, and the wound cleansing layer has two, three or more wound cleansing areas lying next to one another in strip form with differing wound cleansing properties, one of the wound cleansing areas being an absorption area for absorbing wound fluids and one of the wound cleaning areas being an abrasion area for removing Fibrin coverings, dead tissue, horn material, and wherein at least one abrasion area is arranged between two absorption areas.
    [2]
    2. Wound cleaning device according to claim 1, characterized in that the cleaning elements, preferably designed as staple fibers, have monofilaments and / or multifilaments made of plastic.
    [3]
    3. Wound cleaning device according to claim 2, characterized in that at least some cleaning elements are designed as optionally twisted bundles of two, three or more monofilaments.
    [4]
    4. Wound cleansing device according to one of the preceding claims, characterized in that the natural fibers and / or chemical fibers have a diameter of 500 μm or less, in particular 150 μm or less.
    [5]
    5. Wound cleaning device according to one of the preceding claims, characterized in that the natural fibers and / or man-made fibers have a diameter of 5 μm or more, in the case of cleaning elements designed as monofilaments 10 μm or more, in particular more than 20 μm, preferably 30 μm or more, especially preferably 45 µm or more.
    [6]
    6. Wound cleaning device according to one of the preceding claims, characterized in that the effective length of the loops is 2 mm or more, preferably 3 mm or more, in particular 6 mm or more.
    [7]
    7. Wound cleaning device according to one of the preceding claims, characterized in that the effective length of the loops is 20 mm or less, in particular 15 mm or less, particularly preferably 13 mm or less, possibly 11 mm or less.
    [8]
    8. Wound cleaning device according to one of the preceding claims, characterized in that the modulus of elasticity of the material of the natural fibers and / or chemical fibers is 135,000 N / mm or less, especially 100,000 N / mm or less, preferably 50,000 N / mm or less, particularly preferably 5000 N / mm or less and / or 100 N / mm2 or more, in particular 250 N / mm or more, possibly 500 N / mm or more.
    [9]
    9. Wound cleaning device according to one of the preceding claims, characterized in that at least some cleaning elements consist at least partially, preferably completely, of polyester, nylon, polyethylene, polypropylene, aramid, cellulose and / or polyamide.
    [10]
    10. Wound cleaning device according to one of the preceding claims, characterized in that an abrasive is on the surface of at least one cleaning element
    [11]
    11.
    [12]
    12.
    [13]
    13.
    [14]
    14th
    [15]
    15th
    [16]
    16.
    [17]
    17th
    [18]
    18th
    [19]
    19th
    [20]
    20th
    [21]
    21st
    [22]
    22nd
    [23]
    23.
    Austrian AT 16 879 U2 2020-11-15
    is upset.
    Wound cleaning device according to claim 10, characterized in that the abrasive comprises corundum, zirconium, silicon carbide, boron nitride, chromium oxide, flint, emery, garnet, boron nitride, in particular cubic boron nitride and / or diamond.
    Wound cleaning device according to claim 11, characterized in that the abrasive has a grain size in the range between 50 and 1000 mesh, in particular between 150 and 800 mesh.
    Wound cleaning device according to one of the preceding claims, characterized in that the absorption area has chemical fibers and / or natural fibers, in particular monofilaments and / or multifilaments made of plastic with an effective fiber length of 2 mm or more, preferably 3 mm or more, in particular 6 mm or more.
    Wound cleaning device according to one of the preceding claims, characterized in that at least one abrasion area has chemical fibers and / or natural fibers, in particular monofilaments and / or multifilaments with an effective fiber length of 10 mm or less, in particular 5 mm or less, preferably 3 mm or less and / or the effective fiber length in an abrasion region arranged between two absorption regions is 90% or less, in particular 50% or less, particularly preferably 30% or less of the effective fiber length of the absorption regions.
    Wound cleansing device according to one of the preceding claims, characterized in that at least one abrasion area and at least one absorption area are arranged on a common carrier layer.
    Wound cleansing device according to claim 15, characterized in that the common carrier layer is essentially flat and the boundary surfaces of the absorption and abrasion areas facing away from the carrier layer form a profiled cleaning surface.
    Wound cleansing device according to claim 15, characterized in that the carrier layer is profiled and the boundary surfaces of the absorption and abrasion areas facing away from the carrier layer are arranged approximately in a common plane.
    Wound cleaning device according to one of the preceding claims, characterized in that the abrasion areas form a line, grid and / or network structure separating the absorption areas from one another.
    Wound cleaning device according to claim 18, characterized in that the distance between two absorption areas separated from one another by an abrasion area is 10% or more, preferably 30% or more, in particular 50% or more and / or 150% or less, in particular 100% or less, especially preferably 90% or less of the effective fiber length of the fibers of the absorption region.
    Wound cleaning device in particular according to one of the preceding claims, in which at least some cleaning elements are at least partially equipped with an antimicrobial coating, characterized in that the antimicrobial coating has two metals that differ from one another, preferably present as bi-metal particles.
    Wound cleaning device according to Claim 20, characterized in that the antimicrobial coating has silver and / or ruthenium.
    Wound cleaning device according to Claim 20 or 21, characterized in that the antimicrobial coating has a vitamin or a vitamin derivative, the vitamin preferably being ascorbic acid.
    Wound cleaning device according to one of Claims 20 to 22, characterized in that the antimicrobial coating has a surface-active substance.
    [24]
    24. Wound cleaning kit with a sterile wound cleaning device according to one of the preceding claims accommodated in a pack.
    1 sheet of drawings
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    同族专利:
    公开号 | 公开日
    US20210244431A1|2021-08-12|
    AU2019336327A1|2021-03-25|
    DE202019105913U1|2019-11-20|
    WO2020049038A1|2020-03-12|
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    AT16879U3|2020-11-15|
    CN113164286A|2021-07-23|
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    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    DE102018121501.0A|DE102018121501A1|2018-09-04|2018-09-04|Wound cleaning device|
    DE202019100062.7U|DE202019100062U1|2019-01-08|2019-01-08|Wound cleaning device|
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