Medical article for fixation of a wound dressing
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.
1 . A medical article for fixation of a wound dressing, consisting of: a non-woven backing layer ( 1 ) with a top side ( 1 a ) and a bottom side ( 1 b ), a first plastic film layer ( 2 ) with a top side ( 2 a ) and a bottom side ( 2 b ), wherein the top side of the first plastic film layer ( 2 a ) is attached to the bottom side of the non-woven backing layer ( 1 b ), an adhesive silicone gel layer ( 3 ) with a top side ( 3 a ) and a bottom side ( 3 b ), wherein the top side of the adhesive silicone gel layer ( 3 a ) is attached to the bottom side of the first plastic film layer ( 2 b ), and a protection layer ( 4 , 5 , 6 ) with a top side ( 8 a ) and a bottom side ( 8 b ), wherein the top side of the protection layer ( 8 a ) is releasably attached to the bottom side of the adhesive silicone gel layer ( 3 b ), wherein the protection layer ( 4 , 5 , 6 ) comprises a second plastic film layer ( 4 ) with a top side ( 4 a ), a bottom side ( 4 b ) and a single wave-shaped cut line ( 7 ) along its length extension, and wherein the second plastic film layer ( 4 ) is transparent, and a colored tape ( 5 , 6 ) is attached to the bottom side of the second plastic film layer ( 4 b ) along the single wave-shaped cut line ( 7 ), wherein the single wave-shaped cut line ( 7 ) also penetrates the colored tape ( 5 , 6 ).
2 . A medical article according to claim 1 , wherein the medical article has a peel adhesion at 180° on Bristol paper, determined according to FINAT No. 1, from 1.3 N/25 mm to 2.1 N/25 mm.
3 . A medical article according to claim 2 , wherein the medical article has a peel adhesion at 1800 on Bristol paper, determined according to FINAT No. 1, from 1.3 N/25 mm to 1.6 N/25 mm.
4 . A medical article according to claim 1 , wherein the medical article has a moisture vapor transmission rate, determined according to EN 13726-2 (chapter 3.2), of at least 500 g/m 2 /24 h.
5 . The medical article according to claim 4 , wherein the medical article has a moisture vapor transmission rate, determined according to EN 13726-2 (chapter 3.2), of at least 680 g/m 2 /24 h.
6 . A medical article according to claim 1 , wherein the medical article has a resistance to wet bacterial penetration, determined according to EN ISO 22610:2006, of at least 2.8.
7 . The medical article according to claim 6 , wherein the medical article has a resistance to wet bacterial penetration, determined according to EN ISO 22610:2006, of at least 5.
8 . A medical article according to claim 1 , wherein the first plastic film layer ( 2 ) is a coating.
9 . A medical article according to claim 8 , wherein the coating is a transfer coating.
10 . A medical article according to claim 1 , wherein the adhesive silicone gel layer ( 3 ) is a coating.
11 . A medical article according to claim 10 , wherein the coating is a transfer coating.
12 . 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 ( 1 a ) and a bottom side ( 1 b ), ii. coating the bottom side of the backing layer ( 1 b ) with a first composition forming a first plastic film layer ( 2 ), said first plastic film layer ( 2 ) having a top side ( 2 a ) and a bottom side ( 2 b ), wherein the top side of the first plastic film layer ( 2 a ) is attached to the bottom side of the backing layer ( 1 b ), iii. coating of the bottom side of the first plastic film layer ( 2 b ) with a second composition forming an adhesive silicone gel layer ( 3 ), said adhesive silicone gel layer ( 3 ) having a top side ( 3 a ) and a bottom side ( 3 b ), wherein the top side of the adhesive silicone gel layer ( 3 a ) is attached to the bottom side of the first plastic film layer ( 2 b ), and iv. providing a protection layer ( 4 , 5 , 6 ) with a top side ( 8 a ) and a bottom side ( 8 b ), and v. covering the bottom side of the silicone gel layer ( 3 b ) with the protection layer ( 4 , 5 , 6 ), wherein the top side of the protection layer ( 8 a ) is releasably attached to the bottom side of the silicone gel layer ( 3 b ).
13 . The method according to claim 12 , wherein the coating step is a transfer coating step.
14 . A medical article according to claim 1 , wherein the medical article is provided in the form of a roll.
15 . A medical article according to claim 1 , wherein the medical article does not comprise separation lines.
16 . A medical article according to claim 1 , wherein the medical article has a waterproofness, determined according to EN ISO 13726-3:2002, of at most 300 s.
17 . A medical article according to claim 1 , wherein the first plastic film layer ( 2 ) comprises polyurethane.
18 . A medical article according to claim 1 , wherein the first plastic film layer ( 2 ) has a coating weight from 10 g/m 2 to 15 g/m 2 .
19 . A medical article according to claim 1 , wherein the adhesive silicone gel layer ( 3 ) has a coating weight from 70 g/m 2 to 90 g/m 2 .
20 . A medical article according to claim 1 , wherein the first plastic film layer ( 2 ) is formed using a liquid coating solution of a polyurethane.
21 . 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.
22 . A medical article according to claim 1 , wherein the first plastic film layer ( 2 ) consists of polyurethane.