MECHANICAL WOUND CLEANSING DEVICE

Abstract

The present invention relates to a mechanical wound cleansing device comprising a carrier layer and an abrasive loop system arranged above the carrier layer, whereby the loop system is an intermeshed fiber system which is intermeshed above the carrier layer and/or a loop system comprising highly and softly abrasive loops. The present invention further relates to a method of producing said mechanical wound cleansing device. The present invention finally relates to the use of said wound cleansing device for the abrasive removal of and cleansing of wounds, especially for venous leg ulcers, diabetic foot ulcers (neuropathic and neuro-ischemic), arterial ulcers, mixed etiology ulcers, pressure ulcers or traumatic wounds.

Claims

1. A wound cleansing device, comprising: a carrier layer and a loop system made from fibers, wherein the loop system is arranged on at least one side of the carrier layer and protrudes from the carrier layer, wherein the loop system is an intermeshed fiber system which is intermeshed within or below the carrier layer, wherein the loop system comprises highly and softly abrasive loops, and wherein the intermeshed loop fiber system comprises a stitchbonded structure.

2. The wound cleansing device according to claim 1, wherein the highly abrasive loops are made from fibers selected from the group consisting of: (a) multifilament-yarns with a thickness of between 167 and 1500 dtex or between 500 and 1500 dtex which are made from microfilaments; (b) core-twisted yarns having a monofilament core surrounded by finer filaments or microfilaments; (c) monofilaments with a thickness of between 1 and 300 dtex or more than 3.1 dtex, or having a diameter of between 0.05 and 0.5 mm.

3. The wound cleansing device according to claim 1, wherein the softly abrasive loops are made from fibers selected from the group consisting of: (a) textured yarns with a thickness of less than 120 dtex; (b) flock threads consisting of a ground thread and microfilaments arranged transversely to the ground thread; (c) yarns with a thickness of less than 600 dtex which are made from microfilaments or a thickness of between 76 to 334 dtex, or a thickness of between 150 to 200 dtex, or a thickness of 167 dtex; (d) monofilaments with a thickness of less than 1 dtex.

4. The wound cleansing device according to claim 1, wherein the highly abrasive loops have a height above the carrier layer which is less than the height of the softly abrasive loops.

5. The wound cleansing device according to claim 1, wherein the highly abrasive loops and the softly abrasive loops exhibit one or more of the following arrangements: (a) the highly abrasive loops and the softly abrasive loops are stacked upon each other; (b) the highly abrasive loops and the softly abrasive loops are arranged side by side; (c) the highly abrasive loops form a pile loop area which is separated from a pile loop area formed by the softly abrasive loops.

6. The wound cleansing device according to claim 1, wherein the carrier layer and/or the loop-forming fibers are made from natural, semisynthetic or synthetic fibers.

7. The wound cleansing device according to claim 1, whereby the carrier layer is selected from the list consisting of: a nonwoven fabric; a woven fabric; a net; a knitted fabric; and wherein the carrier layer is a nonwoven having a content of from 5% to 35% low melt fibers or bicomponent fibers.

8. The wound cleansing device according to claim 1, whereby the stitch-bonded structure of the intermeshed loop fiber system has one of the following knitting patterns: warp knitting, tricot or atlas.

9. The wound cleansing device according to claim 1, further comprising a liquid absorbing layer selected from a list consisting of non-woven, foam or a textile composite.

10. The wound cleansing device according to claim 9, whereby the foam is made from one of the following polymers: polyurethane, polyacrylamide, Polyethylene.

11. The wound cleansing device according to claim 9, whereby the liquid absorbing layer is arranged on the opposite side of the carrier layer with regard to the loop system.

12. The wound cleansing device according to claim 9, whereby the liquid absorbing layer is soaked with an aqueous liquid, selected from Ringer solution, normal saline, solution comprising undecylenamidopropyl-betain and Polyhexanide.

13. The wound cleansing device according to claim 1, further comprising a top layer of liquid impermeable layer, made of a material selected from polyethylene, polypropylene, polyester or polyamide.

14. The wound cleansing device according to claim 1, further comprising a handle, a grip, a hand strap, or a packet.

15. A method for manufacturing the wound cleansing device according to claim 1, comprising the following steps: (a) provision of a nonwoven; (b) generating a loop system arranged on the nonwoven of step (a) by using a stich bonding process containing a pile thread and a sewing thread; (c) heating of the structure generated in (b) to activate the low melt fibers of the carrier layer; (d) optionally adhering a foam layer on the back side of the carrier layer; (e) optionally laminating the back side of the carrier layer of the structure generated in (c) or the surface of the foam layer as introduced in step (d); and (f) optionally cutting and sealing the device by ultrasonic sealing.

16. A use of the wound cleansing device according to claim 1, in one or more of the following: (a) the removal of necrotic material, eschar, devitalised tissue, serocrusts, infected tissue, hyperkeratosis, slough, pus, haematomas, foreign bodies, debris, bone fragments or any other type of bioburden from a wound with the objective to promote wound healing; (b) the liberation of wound edges and/or the peri-wound skin; and (c) treatment of venous leg ulcers, diabetic foot ulcers (neuropathic and neuro-ischemic), arterial ulcers, mixed etiology ulcers, pressure ulcers or traumatic wounds.

17. An arrangement comprising at least one wound cleansing device according to claim 1, packaged within a sealed package, whereby the sealed package is an air-tight plastic package and the at least one wound cleansing device is packaged in a sterile fashion.

18. The wound cleansing device of claim 3, wherein the textured yarns comprise chenille.

19. The wound cleansing device according to claim 6, wherein the natural fibers are cellulose fibers comprising cotton fibbers, the semisynthetic fibers comprise viscose fibers or acetate fibers, and the synthetic fibers are made from a polymer selected from polyester, polyacrylonitrile (PAN), polyethylene, polypropylene or polyamide.

20. The wound cleansing device of claim 8, wherein the intermeshed loop fiber system has a rip or square optic.

21. The method of claim 15, wherein the nonwoven is made of Polyester with 100-200 g/m.sup.2.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0125] These and other aspects of the present invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

[0126] The present invention will now be described, by way of example, based on embodiments with reference to the accompanying drawings. In the drawings:

[0127] FIG. 1 shows a principal sketch of the wound cleansing device 1 according to a first embodiment in cross section with fiber loops of bulky microfilaments fiber loops 3 as softly abrasive fiber loops and monofilament loops 4 as highly abrasive fiber loops arranged on a carrier layer as alternating loop arrangement (A) as superimposed loops (B) or as discrete areas of highly and softly abrasive loops (C).

[0128] FIG. 2 shows in (A) the photographic reproduction of a wound cleansing device 1 with rows of intermeshed fiber loops from above, and in (B), a principal sketch of a wound cleansing device with areas 5 of fiber loops arranged on the carrier layer 2.

[0129] FIG. 3 shows a principal sketch of a wound cleansing device 1 in cross section with areas 5 of fiber loops arranged on the carrier layer 2 and a liquid absorbing layer 6 arranged on the opposite site of the carrier layer and overlaid by a liquid impermeable layer 7.

[0130] FIG. 4 shows four possible weave patterns for the pile threads as lapping diagrams with two different tricot-fringes in (A) and (B), a satin weave in (C) and a closed tricot weave in (D).

[0131] FIG. 5 shows two possible weave patterns for the pile threads as lapping diagrams in (A) and (B) with plain weave in (A) and a velvet lapping in (B), and furthermore two possible weave patterns for the ground threads as lapping diagrams in (C) and (D) with closed fringe in (C) and open fringe in (D).

[0132] In the Figures, like numbers refer to like objects throughout. Objects in the Figures are not necessarily drawn to scale.

DETAILED DESCRIPTION OF EMBODIMENTS

[0133] Various embodiments of the present invention will now be described by means of the Figures.

[0134] FIG. 1 shows in (A) a wound cleansing device 1 with a carrier layer 2 having on its upper side an alternating mixture of softly abrasive fiber loops 3 and highly abrasive fiber loops 4 in a side-by-side configuration. In the embodiment shown in (B), the softly abrasive fiber loops 3 are arranged below the highly abrasive fiber loops 4. The wound cleansing device 1 according a further embodiment as shown in (C) has a carrier layer with areas of softly abrasive fiber loops separated from areas of highly abrasive fiber loops.

[0135] FIG. 2 shows in (A) a photographic reproduction of a wound cleansing device according to one embodiment of the present invention. The softly abrasive loops build a dense network of bushy fiber loops arranged in stripes with separating loop-free lanes, the so called cleansing lanes. The mesh-like structures which are seen in the cleansing lanes are generated by the sewing threads strengthening the non-woven carrier layer. The wound cleansing device 1 shown in (B) has a rectangular carrier layer with rounded corners. The carrier layer is equipped on the left side with an area of softly abrasive fibers build up by several rectangular fiber loop-carrying sub-areas divided by cleansing lanes and on the right side with an area of highly abrasive fibers build up by several rectangular fiber loop-carrying sub-areas divided by cleansing lanes.

[0136] FIG. 3 shows a further embodiment of the cleansing device 1 with a carrier layer 2, exhibiting on the lower side (i.e., oriented towards the wound) several separated areas of abrasive fiber loops and on the upper side a liquid absorbing layer 6 with a liquid impermeable layer 7 as top layer.

[0137] While the present invention has been illustrated and described in detail in the drawings and the foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive.

[0138] Variations to the disclosed embodiments can be understood and effected by those skilled in the art, from a study of the drawings, the disclosure and the appended claims. In the claims, the word comprising does not exclude other elements or steps, and the indefinite article a or an does not exclude a plurality of elements or steps. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.

[0139] Any reference signs in the claims should not be construed as limiting the scope thereof.

Definitions

[0140] According to one embodiment of the present invention, a loop system is a multitude of fiber or filament loops arranged on the carrier system and protruding from the carrier system in a predetermined regular way.

[0141] As used herein, a monofilament is defined as a single untwisted synthetic filament.

[0142] The term yarn is defined as a long, continuous length of interlocked fibers. These fibers could be either natural, semi-synthetic fibers or filaments. The interlocking can be by twisting, plying or grouping together.

[0143] The microfilaments referred to herein are defined as continuous strands having a diameter in the region of about 17 to 20 m or a linear density of between 0.3 and 1.0 dtex. The term dtex means decitex and is a unit expressing the linear density as the mass in grams of a 10,000 meter length of one filament. An alternative means of expressing the definition of a microfilament may be by reference to fiber thickness, which is generally expressed as a fiber diameter.

[0144] The term nanofilaments which is synonymous with the term super-microfilaments denotes to filaments with cross-sectional dimensions of less than 1 m or a liner density of less than 0.3 dtex.

[0145] In the context of the present invention, the term low melt fibers is defined as fibers having a melting point between 110 C. and 180 C.

[0146] The term cleansing as used in the context of the present invention according to one embodiment encompasses the debridement as well as the classical cleaning.

[0147] The term debridement as used herein refers to deeply removing adherent, dead or contaminated tissue from a wound and must be clearly separated from the act of classical cleaning, defined as the removal of dirt (loose metabolic waste or foreign material). Furthermore, debridement does not encompass revision of a wound, resection of functional tissue or amputation. Thus, debridement is defined as the act of removing necrotic material, eschar, devitalised tissue, serocrusts, infected tissue, hyperkeratosis, slough, pus, haematomas, foreign bodies, debris, bone fragments or any other type of bioburden from a wound with the objective to promote wound healing.

[0148] Debridement is sometimes referred to as a form of wound bed preparation; however, it has become clear that not only the wound bed but also the wound edges and the peri-wound skin are important for the successful healing of a wound. Hence, the present definition of the term debridement does not only refer to the removal of bioburden from the wound bed, but also the liberation of wound edges as well as of peri-wound skin.

[0149] The terms proximal and distal are used in the present invention to define the location of certain structures and especially layers in relation to the wound site. Proximal denotes to structures which are closer to the wound site, and distal to structures which are situated further away from the wound site.

[0150] The term non-woven is herein defined as sheet or web structures bonded together by entangling fiber or filaments mechanically, thermally or chemically. They are flat or tufted porous sheets that are made directly from separate fibers or filaments. Non-woven are not made by weaving or knitting and do not require converting the fibers to yarn.