Wound cleaning device

Abstract

Wound cleaning device with a number of strand-shaped cleaning elements, at least one of which extends along an optionally curved strand axis, characterized in that the cut surface of this cleaning element in one, preferably each, strand cutting plane extending perpendicular to the strand axis has an aspect ratio, that is to say a ratio of greatest extent to extent in a transverse direction running perpendicular thereto of 5 or more, in particular 10 or more, preferably 15 or more, but 100 or less, in particular 50 or less, preferably 30 or less.

Description

[0001] The invention relates to a wound cleaning device with a number of strand-shaped cleaning elements, at least one of which extends along an optionally curved strand axis, and to the use of such a wound cleaning device for producing a therapy arrangement.

[0002] Wound cleansing devices of the type described are specified, for example, in EP 2365794. In the wound cleansing device described in this document, the strand-shaped cleaning elements are designed in the form of threads made of synthetic fibers, whereby the threads can also be in the form of monofilament fibers. Each thread extends along a corresponding strand axis. With these wound cleansing devices, what is known as debridement can be carried out particularly gently. Debridement is the process of wound bed preparation in which substances produced by the body itself, i.e., human material such as excessive fluids, fibrin deposits, dead epidermal tissue, such as excessive horny material or dead horny cells and / or deposits of dead tissue (necrosis), are removed.

[0003] The known wound cleansing devices are designed as wound cleansing wipes, with the wound cleansing elements, realized as threads, extending from a carrier layer. They form a pile in which the effective length of the threads between a carrier layer and the end of the threads facing away from the carrier layer, also referred to as the pile height, is between 3 and 30 mm, and the threads have a density between 0.5 and 20 dtex.

[0004] In the wound cleaning devices known from EP 2365794, the removal of dead epidermal tissue is to be promoted by the fact that the threads are designed with freely projecting ends, wherein the end faces of the freely projecting ends enclose an angle with the strand axis, which produces a razor blade effect in the region of the transition between the end faces of the threads and the lateral surfaces of the threads.

[0005] However, it has been shown that the wound cleansing devices known from WO 2020 / 049038 cannot satisfactorily remove stubbornly adhering substances from the wound, such as those found in burns, necrosis, or some fibrin coatings. To remedy this deficiency, WO 2020 / 049038 proposes a further development of the known wound cleansing devices, in which the removal of stubbornly adhering substances from the wound is to be promoted by the strand-shaped cleaning elements having a cleaning quotient (R = (E x F) / l, where E denotes the elastic modulus of the material from which the cleaning elements are made, F denotes the mean cross-sectional area of ​​the cleaning elements in a strand cutting plane running perpendicular to the strand axis, and l denotes the effective length of the cleaning elements) of 0.5 N / mm or greater and 1000 N / mm or less.This is intended to give the cleaning elements sufficient rigidity to achieve a balanced compromise between satisfactory cleaning on the one hand and acceptable mechanical stress on the wound during cleaning on the other.

[0006] However, it has been shown that the choice of a cleaning ratio sufficient to remove stubbornly adhering substances within the scope of the invention described in WO 2020 / 049038 can, in some cases, result in unacceptable mechanical stress on the wound during cleaning. This can impair wound healing.

[0007] In view of these problems in the prior art, the object of the invention is to provide a wound cleaning device with which satisfactory wound cleaning is possible without complications in wound healing.

[0008] According to the invention, this object is achieved by a further development of the known wound cleaning devices, which is essentially characterized in that the cut surface of the strand-shaped cleaning elements in one, preferably each, strand cutting plane extending perpendicular to the strand axis has an aspect ratio, that is to say a ratio of greatest extent to extent in a transverse direction running perpendicular thereto, of 5 or more, in particular 10 or more, preferably 15 or more, but 100 or less, in particular 50 or less, preferably 30 or less.

[0009] To illustrate the invention, a cleaning element with a rectangular cross-sectional area in the strand cutting plane is considered as an example. For such cleaning elements, the aspect ratio refers to the ratio of the length of the diagonal of the rectangle to the dimension of the rectangle in a transverse direction perpendicular to the diagonal. For a particularly large aspect ratio, this is approximately described by the ratio of the longer side of the rectangle to the shorter side of the rectangle. For a cleaning element with an elliptical cross-sectional area, the aspect ratio refers to the ratio of the major semi-axis to the minor semi-axis.

[0010] With cleaning devices according to the invention, a razor blade effect, which in wound cleaning devices according to EP 2365794 only occurs in the area of ​​the end faces of the cleaning elements, can be achieved over the entire length of the cleaning element. Thus, each individual wound cleaning element forms a microcurette, which can promote the removal of stubbornly adhering substances from the wound over the entire length of the wound cleaning element.

[0011] Unlike the wound cleansing devices described in WO 2020 / 049038, the removal of stubbornly adhering substances is not achieved by increasing the stiffness of the individual cleansing elements, but rather by optimizing the geometric shape of these wound cleansing elements. This prevents impairment of wound healing due to injuries during wound bed preparation while simultaneously achieving satisfactory wound bed cleansing.

[0012] It has been shown that to achieve the described effect, it is sufficient if the aspect ratio of the cleaning elements is 5 or more. However, to maintain sufficient stability of the individual wound cleaning elements, the aspect ratio must be set to a value of 100 or less. Particularly good results are achieved when the aspect ratio is in the range between 10 and 50, especially in the range between 15 and 30.

[0013] In order to ensure sufficient mechanical stability of the individual wound cleansing elements, it has proven expedient if the greatest extent of the strand element in the strand cutting plane is 0.1 mm or more, in particular 0.2 mm or more, particularly preferably 0.4 mm or more. In order to avoid excessively stiff and thus aggressive structures, it has proven expedient if the greatest extent of the strand element in the strand cutting plane is 2 mm or less, in particular 1 mm or less, such as approximately 0.5 mm or less. Accordingly, the extent of the strand elements in the transverse direction in wound cleansing devices according to the invention is expediently 0.01 mm or more, in particular 0.02 mm or more, but 0.2 mm or less, in particular 0.1 mm or less.

[0014] Similar to known wound cleansing devices, wound cleansing devices according to the invention provide a carrier layer, wherein the strand-shaped wound cleansing elements can have an exposed region outside this carrier layer. Sufficient deformability of the cleansing elements is achieved in order to avoid impairment of wound healing during wound bed preparation if the length of the exposed region along the strand axis is 2 mm or more, in particular 4 mm or more, optionally 6 mm or more. Excessive deformability of the individual cleansing elements, which is disadvantageous in connection with the detachment of stubbornly adhering substances, can be avoided if the length of the exposed region is 20 mm or less, in particular 10 mm or less.

[0015] Within the scope of the invention, it has proven expedient, in order to utilize a razor blade effect over as large a section of the length of the individual cleaning elements as possible, for the exposed area to be loop-shaped, i.e. to exit from the carrier layer at an exit point and re-enter the carrier layer at an entry point, the distance between the exit point and the entry point being expediently 2 mm or less, in particular 1 mm or less, in order to form an effective loop.

[0016] With a wound cleansing device according to the invention, a flat and thus particularly rapid wound cleansing can be achieved if the density of the exposed areas, in particular the number of loop-shaped areas per area of ​​the carrier layer, is 10 / cm 2 or more, especially 20 / cm 2or more, although in order to create sufficient absorption capacity between the individual wound cleansing elements, preferably less than 200 wound cleansing elements per cm 2 the surface of the carrier layer.

[0017] From a production perspective, it has proven advantageous if two, three, or more exposed areas are formed by connected sections of a fiber, particularly a strip-shaped fiber, especially a monofilament fiber. Then the wound cleansing elements can be woven or knitted into the carrier layer.

[0018] To achieve the aspect ratio desired by the invention, wound cleansing elements according to the invention can be designed as strip-shaped fibers with an approximately rectangular or elliptical cross-section, wherein the individual fibers can be designed as synthetic fibers with polyester and / or polyamide components. The fiber can consist of 90 wt.% or more polyester and 10 wt.% or less polyamide, in particular 92 wt.% polyester and 8 wt.% polyamide.

[0019] The carrier layer of wound cleansing devices according to the invention can comprise a woven and / or knitted fabric made of monofilament and / or multifilament fibers. The aspect ratio of the fibers forming the carrier layer can also be approximately 1, while the aspect ratio of the fibers woven or knitted into the carrier layer to form wound cleansing elements can be set to a value between 5 and 50 within the scope of the invention.

[0020] As already mentioned above, at least one cleaning element of wound cleaning devices according to the invention can have an approximately trapezoidal, in particular rectangular, cross-sectional area in a strand cutting plane.

[0021] Within the scope of the invention, it is also conceivable to equip the wound cleansing device with two, three, or more wound cleansing areas, wherein the individual wound cleansing areas can have different wound cleansing properties. Two wound cleansing areas can be arranged on opposite sides of the carrier layer.

[0022] A combination of advantages achieved according to the invention with advantages of wound cleaning devices according to EP 2365794 can be achieved if one wound cleaning area has cleaning threads with freely projecting ends, while the other wound cleaning area has loop-shaped cleaning elements, wherein the cleaning threads with freely projecting ends can have an effective length between the carrier layer and the end of the threads facing away from the carrier layer of between 3 and 30 mm and these threads can have between 0.5 and 20 dtex, while the loop-shaped cleaning elements can have an aspect ratio of between 5 and 50 with the dimensions described above.

[0023] A wound cleansing kit according to the invention comprises a wound cleansing device according to the invention contained in a sterile package.

[0024] Within the scope of the invention, the use of a wound cleansing device according to the invention for producing a therapy device for the treatment of burns and / or necroses and / or fibrin deposits and / or biofilms and / or bacterial contamination is particularly contemplated. Accordingly, the wound cleansing device according to the invention is designed for use in a method for the treatment of burns and / or necroses and / or fibrin deposits and / or biofilms and / or bacterial contamination.

[0025] It should be noted that the features explained above, individually and in combination with one another, are essential for the success sought by the invention (wound bed preparation). QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] EP 2365794 [0002, 0004, 0010, 0022] WO 2020 / 049038 [0005, 0006, 0011]

Claims

[1] Wound cleaning device with a number of strand-shaped cleaning elements, at least one of which extends along an optionally curved strand axis, characterized by that the cut surface of this cleaning element in one, preferably each, strand cutting plane extending perpendicular to the strand axis has an aspect ratio, that is to say a ratio of greatest extent to extent in a transverse direction running perpendicular thereto of 5 or more, in particular 10 or more, preferably 15 or more, but 100 or less, in particular 50 or less, preferably 30 or less. [2] Wound cleaning device according to claim 1, characterized bythat the greatest extent of the strand element in the strand section plane is 0.1 mm or more, in particular 0.2 mm or more, preferably 0.4 mm or more, but 2 mm or less, in particular 1 mm or less, and / or the extent of the strand element in the transverse direction is 0.01 mm or more, in particular 0.02 mm or more, but 0.2 mm or less, in particular 0.1 mm or less. [3] Wound cleaning device according to claim 1 or 2, characterized by that at least one strand-shaped wound cleaning element has an area exposed outside a carrier layer. [4] Wound cleaning device according to claim 3, characterized by that the length of the exposed region along the strand axis is 2 mm or more, in particular 4 mm or more, optionally 6 mm or more, but 20 mm or less, in particular 10 mm or less, optionally 8 mm or less. [5] Wound cleaning device according to claim 4, characterized bythat the exposed region is loop-shaped, exits from the carrier layer at an exit point and re-enters the carrier layer at an entry point, the distance between the exit point and the entry point being 2 mm or less, in particular 1 mm or less. [6] Wound cleaning device according to one of claims 3 to 5, characterized by that the density of the exposed areas, in particular the number of loop-shaped areas, per area of ​​the carrier layer 10 / cm 2 or more, especially 20 / cm 2 or more, but less than 200 / cm 2 amounts. [7] Wound cleaning device according to one of claims 3 to 6, characterized by that two, three or more exposed regions are formed by contiguous sections of a fiber, in particular a strip-shaped fiber, in particular a monofilament fiber. [8] Wound cleaning device according to claim 7, characterized bythat the strip-shaped fiber comprises a synthetic fiber with polyester and / or polyamide components. [9] Wound cleaning device according to one of claims 3 to 8, characterized by that the carrier layer comprises a woven and / or knitted fabric made of mono- and / or multifilament fibers. [10] Wound cleaning device according to one of the preceding claims, characterized by that at least one wound cleaning element has an approximately trapezoidal, in particular rectangular, cross-sectional area in a strand cutting plane. [11] Wound cleaning device according to one of the preceding claims, characterized by two, three or more wound cleansing areas with differing wound cleansing properties, two of which are preferably arranged on opposite sides of the carrier layer. [12] Wound cleaning device according to claim 1, characterized bythat one wound cleaning area has cleaning threads with freely projecting ends, while the other wound cleaning area has loop-shaped wound cleaning elements. [13] Wound cleansing kit with a wound cleansing device according to one of the preceding claims, accommodated in a sterile package. [14] Use of a wound cleaning device according to one of claims 1 to 12 for producing a therapy arrangement for the treatment of burns and / or necroses and / or fibrin deposits and / or biofilms and / or bacterial contamination. [15] Wound cleaning device according to one of claims 1 to 12 for use in a method for the treatment of burns and / or necroses and / or fibrin deposits and / or biofilms and / or bacterial contamination.