Methods for manufacturing and assembling dual material tissue interface for negative-pressure therapy

Patent metadata

Field	Value
Publication number	US-11207217-B2
Application number	US-201816000284-A
Country	US
Kind code	B2
Filing date	Jun 5, 2018
Priority date	Jun 7, 2017
Publication date	Dec 28, 2021
Grant date	Dec 28, 2021

Abstract

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.

First claim

What is claimed is:

1. A method of manufacturing a dressing for negative-pressure treatment, the method comprising:
applying a cross-linkable polymer to a first side and a second side of a polymer film;
curing the cross-linkable polymer on at least the first side of the polymer film to a gel layer to form a coated polymer film;
perforating the coated polymer film to form fluid restrictions; and
bonding a manifold to the second side of the polymer film;
wherein bonding the manifold to the second side of the polymer film is performed prior to curing the cross-linkable polymer.

2. The method of claim 1 , wherein the gel layer has a thickness of about 30 μm to about 100 μm.

3. The method 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.

4. The method of claim 1 , wherein the cross-linkable polymer is applied to the polymer film by laminating, rolling, dipping, transferring or spraying the cross-linkable polymer on the polymer film.

5. The method of claim 1 , wherein the curing step is performed by a cure type selected from the group consisting of a heat cure, an ionizing radiation cure, an addition cure, a free radical cure, a condensation cure or a combination thereof.

6. The method of claim 1 , wherein the cross-linkable polymer is selected from the group consisting of silicone, polyurethane, a thermoplastic elastomer, a superabsorbent polymer and a hydrocolloid.

7. The method of claim 1 , wherein the perforating is performed by laser, knife, or heat.

8. The method of claim 1 , wherein the fluid restrictions comprise slits or slots having a length of about 2 mm to about 4 mm.

9. The method of claim 1 , wherein the fluid restrictions comprise slots having a width of about 0.25 mm to about 1 mm.

10. The method of claim 1 , wherein the fluid restrictions are distributed in a uniform pattern, the uniform pattern comprising a grid of parallel rows and columns.

11. The method of claim 1 , wherein:
the fluid restrictions are distributed in parallel rows and columns;
the rows are spaced about 3 mm on center; and
the fluid restrictions in each of the rows are spaced about 3 mm on center.

12. The method of claim 1 , wherein the fluid restrictions in adjacent rows are offset.

13. The method of claim 1 , wherein the fluid restrictions comprise elastomeric valves that are normally closed.

14. The method of claim 1 , wherein the applying is performed prior to the curing.

15. The method of claim 1 , wherein the manifold comprises foam.

16. The method of claim 15 , wherein the foam is reticulated.

17. The method of claim 16 , wherein the foam is reticulated and has a free volume of at least 90%.

18. The method of claim 15 , wherein the foam is porous and has an average pore size in a range of 400-600 μm.

19. The method of claim 1 , wherein the manifold has a thickness less than 7 mm.

20. The method of claim 1 , wherein the fluid restrictions are coextensive with the manifold.

21. The method of claim 1 , wherein the polymer film is hydrophobic.

22. The method of claim 1 , wherein the polymer film is polyethylene.

23. The method of claim 1 , further comprising curing the cross-linkable polymer on the second side of the polymer film to a gel layer after curing the cross-linkable polymer on the first side.

24. The method of claim 1 , further comprising providing a cover configured to be positioned adjacent the manifold.

25. The method of claim 24 , further comprising applying an attachment device to at least a portion of a tissue facing side of the cover, the attachment device configured to bond the cover to epidermis surrounding a tissue site.

26. The method of claim 25 , further comprising removably coupling a release liner to the attachment device.

27. The method of claim 24 , further comprising:
disposing an aperture in the cover;
coupling a dressing interface to the cover, the dressing interface configured to be fluidly coupled to the manifold through the aperture; and
fluidly coupling a fluid conductor to the dressing interface.

Assignees

• Kci Licensing Inc

Inventors

• Locke Christopher Brian
• Robinson Timothy Mark

Classifications

• A61M1/96 Primary

  Suction control thereof · CPC title

• A61M1/92

  with liquid supply means · CPC title

• A61M1/916

  specially adapted for deep wounds · CPC title

• A61M1/912

  Connectors between dressing and drainage tube · CPC title

• A61M1/915

  Constructional details of the pressure distribution manifold · CPC title