MEDICAL ARTICLE FOR FIXATION OF A WOUND DRESSING

Abstract

The present invention relates to a medical article for fixation of a wound dressing as well as its use and manufacturing method. The medical article comprises a non-woven backing layer. A plastic film layer is attached to the bottom side of the non-woven backing layer. An adhesive silicone gel layer is then in turn attached to the bottom side of the plastic film layer. Preferably, the medical article is provided in the form of a roll. The medical article according to the present invention may provide an easy to apply, secure, skin-friendly, painless and gentle fixation of a primary dressing such as a compress on the body of a patient.

Claims

1. A medical article for fixation of a wound dressing, comprising a non-woven backing layer (1) with a top side and a bottom side, a first plastic film layer (2) with a top side and a bottom side, wherein the top side of the first film layer (2) is attached to the bottom side of the backing layer (1), an adhesive silicone gel layer (3) with a top side and a bottom side, wherein the top side of the silicone gel layer (3) is attached to the bottom side of the first film layer (2), and optionally a protection layer (4, 5, 6) with a top side and a bottom side, wherein the top side of the protection layer (4, 5, 6) is releasably attached to the bottom side of the silicone gel layer (3).

2. A medical article according to claim 1, wherein the article is provided in the form of a roll.

3. A medical article according to claim 1, wherein the article does not comprise separation lines.

4. A medical article according to claim 1, wherein the article has a peel adhesion at 180 on Bristol paper, determined according to FINAT No. 1, of from about 1.3N/25 mm to about 2.1N/25 mm.

5. A medical article according to claim 1, wherein the article has a moisture vapor transmission rate, determined according to EN 13726-2 (chapter 3.2), of at least 500 g/m.sup.2/24 h.

6. A medical article according to claim 1, wherein the article has a waterproofness, determined according to EN ISO 13726-3:2002, of at most 300 s.

7. A medical article according to claim 1, wherein the article has a resistance to wet bacterial penetration, determined according to EN ISO 22610:2006, of at least 2.8.

8. A medical article according to claim 1, wherein the first film layer (2) comprises polyurethane.

9. A medical article according to claim 1, wherein the first film layer (2) is a coating.

10. A medical article according to claim 1, wherein the silicone gel layer (3) is a coating.

11. A medical article according to claim 1, wherein the first film layer (2) has a coating weight of from about 10 g/m.sup.2 to about 15 g/m.sup.2.

12. A medical article according to claim 1, wherein the silicone gel layer (3) has a coating weight of from about 70 g/m.sup.2 to about 90 g/m.sup.2.

13. A medical article according to claim 1, wherein the first film layer (2) is formed using a liquid coating solution of a polyurethane.

14. A medical article according to claim 1, wherein the protection layer comprises a second plastic film layer (4) with a top side, a bottom side and a single wavelike cut line (7) along its length extension.

15. A method of fixing a wound dressing comprising applying the medical article of claim 1 on a body of a patient in need of a wound dressing.

16. A method of manufacturing a medical article according to claim 1, comprising the steps of: i. providing a non-woven backing layer (1) with a top side and a bottom side, ii. coating the bottom side of the backing layer (1) with a first composition forming a first plastic film layer (2), said first plastic film layer (2) having a top side and a bottom side, wherein the top side of the first plastic film layer (2) is attached to the bottom side of the backing layer (1), iii. coating the bottom side of the first plastic film layer (2) with a second composition forming an adhesive silicone gel layer (3), said adhesive silicone gel layer (3) having a top side and a bottom side, wherein the top side of the adhesive silicone gel layer (3) is attached to the bottom side of the first plastic film layer (2), and iv. optionally, providing a protection layer (4, 5, 6) with a top side and a bottom side, and v. optionally, covering the bottom side of the silicone gel layer (3) with the protection layer (4, 5, 6), wherein the top side of the protection layer (4, 5, 6) is releasably attached to the bottom side of the silicone gel layer (3).

17. A medical article according to claim 4, wherein the article has a peel adhesion at 180 on Bristol paper, determined according to FINAT No. 1, of from about 1.3N/25 mm to about 1.6N/25 mm.

18. The medical article according to claim 5, wherein the article has a moisture vapor transmission rate, determined according to EN 13726-2 (chapter 3.2), of at least 680 g/m.sup.2/24 h.

19. The medical article according to claim 7, wherein the article has a resistance to wet bacterial penetration, determined according to EN ISO 22610:2006, of at least 5.

20. The medical article according to claim 14, wherein the second film layer (4) is transparent, and a colored tape (5, 6) is attached to the bottom side of the second film layer (4) along the cut line (7), wherein the cut line (7) also penetrates the tape (5, 6).

21. A medical article according to claim 1, wherein the first film layer (2) consists of polyurethane.

22. A medical article according to claim 9, wherein the coating is a transfer coating.

23. A medical article according to claim 10, wherein the coating is a transfer coating.

24. The method according to claim 16, wherein the coating step is a transfer coating step.

Description

EXAMPLE AND FIGURES

[0038] FIG. 1 shows a preferred embodiment of the medical article according to the invention. The medical article is provided in the form of a roll. The roll may comprise a strip of the medical article with a length of several meters, for example 2 meters. The depicted roll has a width of about 10 cm.

[0039] FIG. 2 shows the top side of a medical article which has been cut off from the roll of FIG. 1. The top side of the medical article is formed by a white non-woven backing layer.

[0040] FIG. 3 shows the bottom side of the medical article of FIG. 2. The bottom side of the medical article is formed by a protection layer, which is transparent apart from a white tape with blue arrows. The tape has a width of about 3 cm. The protection layer comprises a wavelike cut line which is located approximately in the middle of the white tape between the two rows of arrows. The cut line as well as the tape with the arrows greatly facilitate the removal of the protection layer from the medical article. The cut line is hardly visible when observing a sample of the medical article. Therefore,

[0041] FIG. 4 shows the medical article of FIG. 3 in a stretched configuration to better reveal the wavelike cut line of the protection layer.

[0042] FIG. 5 finally shows a schematic cross section of the medical article depicted in the previous figures. The medical article comprises as already mentioned a white non-woven backing layer 1. The backing layer 1 may be made of polyethylene terephthalate fibers. Furthermore, the backing layer 1 may have a thickness of about 0.45 mm and a grammage of about 47 g/m.sup.2. A plastic film layer 2 is attached to the bottom side of the backing layer 1, which is preferably formed as a coating. The film layer 2 may be made of polyurethane. Moreover, the film layer 2 may have a thickness of about 12 m and a coating weight of about 12 g/m.sup.2. An adhesive silicone gel layer 3 is then attached to the bottom side of the film layer 2, which is preferably formed as a coating as well. The coating weight of the silicone gel layer 3 may amount to about 80 g/m.sup.2. The silicone gel layer 3 is covered until use of the medical article by a protection layer already known from the previous figures. The protection layer comprises as main structural component a transparent plastic film layer 4 and a white tape 5, 6 with blue arrows (the arrows are not shown in FIG. 5). The arrow tape of the protection layer is a striking optical feature of the medical article as can be easily seen in the previous figures. Film layer 4 may be made of polyethylene terephthalate. Reference sign 5 indicates an adhesive coating, for example a polymer-based dispersion, of the tape to attach it on the film layer 4, wherein reference sign 6 indicates a further plastic film layer forming the carrier of the tape. Film layer 6 of the tape may be made of polypropylene. Film layers 4 and 6 may both have a thickness of about 50 m and a surface weight of about 70 g/m.sup.2. Finally, a wavelike cut line 7 is present in the protection layer as mentioned before. The cut line 7 divides the protection layer in two parts. To remove the protection layer, the user may bend the medical article along the white tape. This opens the cut line 7 and detaches the two parts of the protection layer from the silicone gel layer 3 in the bended region. The user may then grip each part of the protection layer and pull it off in the direction indicated by the arrows.

[0043] The following table summarizes further features, which the medical article according to the described example may possess. The values mentioned in the table are average values.

TABLE-US-00002 Feature of the medical article Test method Value (average) Grammage without ISO 3801 145 g/m.sup.2 protection layer Peel adhesion at 180 on FINAT No. 1 1.5 N/25 mm bristol paper Peel adhesion between ASTM D 1876 0.04 N/25 mm silicone gel and protection layer Moisture vapor EN 13726-2 (chapter 3.2) 830 g/m.sup.2/24 h transmission rate (MVTR) Waterproofness EN ISO 13726-3: 2002 >300 s Resistance to wet bacterial EN ISO 22610: 2006 5.93 penetration