Methods for manufacturing and assembling dual material tissue interface for negative-pressure therapy
A dressing for treating tissue with negative pressure is provided herein comprising a composite of dressing layers, including a release film, a perforated coated polymer film, a manifold, and an adhesive cover. Additionally, a method of manufacturing the dressing may comprise applying a cross-linkable polymer to a polymer film, curing the cross-linkable polymer to a gel layer to form a coated polymer film, and perforating the coated polymer film to form fluid restrictions, such as slits and/or slots, though the coated polymer film.
1. A dressing for treating a tissue site, comprising:
a coated polymer film comprising a polymer film having a first side and a second side, a gel layer coupled to the first side of the polymer film and configured to be adjacent the tissue site, and a plurality of perforations configured to extend through the polymer film and the gel layer, the plurality of perforations configured to expand in response to a negative pressure applied to the coated polymer film to allow liquid flow;
a manifold configured to be positioned adjacent the coated polymer film; and
a sealing layer configured to cover the manifold;
wherein the polymer film and the gel layer are hydrophobic.
2. The dressing of claim 1 , wherein the gel layer is a first gel layer and the coated polymer film further comprises a second gel layer coupled to the second side of the polymer film.
3. The dressing of claim 1 , wherein the gel layer is configured to be coextensive with the polymer film.
4. The dressing of claim 1 , wherein the gel layer has a thickness of about 30 μm to about 100 μm.
5. The dressing of claim 1 , wherein the gel layer has a peel adhesion of about 0.1 N/2.5 cm to about 2.0 N/2.5 cm.
6. The dressing of claim 1 , wherein the gel layer is formed from a cross-linkable polymer.
7. The dressing of claim 1 , wherein the plurality of perforations comprise a plurality of fluid restrictions.
8. The dressing of claim 1 , wherein the plurality of perforations comprise a plurality of slits.
9. The dressing of claim 8 , wherein the plurality of slits have a length less than about 4 millimeters and a width less than about 1 millimeters.
10. The dressing of claim 8 , wherein the plurality of slits have a length less than about 2 millimeters and a width less than about 0.4 millimeters.
11. The dressing of claim 8 , wherein the plurality of slits have a length of about 3 millimeters and width of about 0.8 millimeters.
12. The dressing of claim 1 , wherein the plurality of perforations are distributed in a uniform pattern, the uniform pattern comprising a grid of parallel rows and columns.
13. The dressing of claim 1 , wherein:
the plurality of perforations are distributed in parallel rows and columns;
the rows are spaced about 3 millimeters on center; and
the plurality of perforations in each of the rows are spaced about 3 millimeters on center.
14. The dressing of claim 1 , wherein the plurality of perforations in adjacent rows are offset.
15. The dressing of claim 1 , wherein the plurality of perforations comprise elastomeric valves that are normally closed.
16. The dressing of claim 1 , wherein the manifold comprises reticulated foam.
17. The dressing of claim 16 , wherein the foam is porous and has a free volume of at least 90%, and wherein the foam has an average pore size in a range of 400-600 μm.
18. The dressing of claim 1 , wherein the manifold has a thickness less than 7 mm.
19. The dressing of claim 1 , further comprising an adhesive configured to be coupled to at least a portion of a tissue-facing side of the sealing layer; and a release layer configured to be positioned adjacent the coated polymer film and removably coupled to the adhesive.