SUB-ATMOSPHERIC WOUND THERAPY SYSTEMS AND METHODS

• US 20170028113A1
• Filed: 07/28/2015
• Published: 02/02/2017
• Est. Priority Date: 07/28/2015
• Status: Active Grant

• Current Assignee: J & M Shuler Medical, Inc.
• Original Assignee: J & M Shuler Medical, Inc.
• Inventors: Shuler, Michael Simms, Runquist, Lars, Carlson, Alan, Leingang, Evan
• Granted Patent: US 10,583,228 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 13/05 specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/918 for multiple suction locations
• CPC Class Codes: A61M 1/92 with liquid supply means

Abstract

Some embodiments of a multi-layered dressing system for sealed wound treatment include various components used for sealing, dressing, suctioning and irrigating that are coupled together as a single, composite unit.

Claims

1. A multilayered dressing system for negative pressure wound therapy, comprising:

a hub including a manifold configured for connection with an inflow line that provides a first fluid pathway to an irrigation fluid source and an outflow line that provides a second fluid pathway to a vacuum source;

a sealing layer comprising a film having a first surface and a second surface, the first surface being coupled to the hub, the second surface comprising a gel adhesive disposed at one or more peripheral locations on the film,

a perforated layer coupled to the second surface of the sealing layer, the perforated layer defining a plurality of pores for fluid flow toward the hub; and

an irrigation network coupled to the perforated layer, the irrigation network including a plurality of tubes in fluid communication with the first fluid pathway, each tube defining a lumen that adjusts from a collapsed condition to an expanded condition when subjected to positive pressure.

2. The system of claim 1, wherein the film of the sealing layer is a transparent plastic film comprising a polyurethane and wherein the film includes a clear adhesive on a wound-facing surface of the film.

3. The system of claim 1, wherein the gel adhesive of the sealing layer is located along the outer perimeter of the second surface of the film.

4. The system of claim 1, wherein the gel adhesive comprises a hydrogel or a hydrocolloid.

5. The system of claim 1, wherein the first and second perforated layers are composed of silicone.

6. The system of claim 1, wherein the first and second perforated layers include pores each having a diameter of about 0.5 millimeters (mm) to about 2 mm.

7. The system of claim 6, wherein the gel adhesive is adapted to releasably bond the system along the peripheral locations of the film to skin located around a wound.

8. The system of claim 1, wherein the sealing layer, the perforated layer and the irrigation network couple together as a single, composite unit such that no assembly is required during use.

9. The system of claim 1, wherein the irrigation network includes a body portion and eight outwardly radiating tubes extending from the body portion.

10. The system of claim 1, wherein the irrigation network includes two, three, four, five, six, seven, eight, nine, or ten tubes.

11. The system of claim 1, wherein the irrigation network is composed of a polyurethane.

12. The system of claim 1, wherein each tube of the irrigation network comprises two sealed edges that extend outwardly away from the lumen.

13. The system of claim 12, wherein the sealed edges of the irrigation network provide an attachment area for directly connecting the irrigation network to at least another portion of the system.

14. The system of claim 1, wherein the irrigation network includes an aperture for receiving an irrigant from the inflow line and the lumens of the plurality of tubes deliver the irrigant to the peripheral edges of a wound.

15. The system of claim 1, wherein at least one of the tubes include protrusions extending radially inward from an inner luminal wall of the lumen to provide flow path patency.

16. The system of claim 15, wherein the protrusions are located fully circumferentially along the inner walls of the lumen.

17. The system of claim 15, wherein the protrusions are located along a top portion or a bottom portion of the lumen.

18. The system of claim 15, wherein each protrusion is a short nub.

19. The system of claim 15, wherein each protrusion is an elongate finger-like extension.

20. A multilayered dressing system, comprising:

a hub having a manifold configured for connection with an inflow line that provides a fluid pathway to an irrigation fluid source;

a sealing layer having a first surface and a second surface, the first surface being coupled to the hub;

a netting layer coupled to the second surface of the sealing layer, the netting layer defining multiple openings for fluid flow toward the hub; and

an irrigation network coupled to the netting layer, the irrigation network including a plurality of tubes in fluid communication with the fluid pathway, each tube defining a lumen that adjusts from a collapsed condition to an expanded condition when subjected to positive pressure.

21. The system of claim 20, wherein the netting layer is a mesh.

22. The system of claim 20, wherein the netting layer is a thin perforated layer.

23. A method of providing negative pressure wound therapy, the method comprising:

obtaining a unified dressing assembly, the unified dressing assembly comprising a pre-assembled arrangement comprising a sealing layer coupled to a hub, a netting layer coupled to a wound-facing surface of the sealing layer, and an irrigation network coupled to the netting layer;

disposing at least a portion of the unified dressing assembly directly on a wound; and

forming an air-tight seal over the wound by coupling at least a portion of the sealing layer to skin surrounding the wound.

24. The system of claim 23, further comprising removing a backing from the sealing layer of a unified dressing assembly.

25. The system of claim 23, further comprising connecting a vacuum line and an irrigant supply line to the hub for providing negative pressure and irrigation to the wound.

26. A multilayered dressing assembly, comprising:

a hub having a manifold configured for connection with an inflow line that provides a fluid pathway to an irrigation fluid source;

a sealing layer having a first surface and a second surface, the first surface being coupled to the hub, the second surface comprising a gel adhesive for adhering the assembly to skin located proximate a wound;

a netting layer coupled to the second surface of the sealing layer; and

an irrigation network coupled to the netting layer.

27. The system of claim 26, wherein the gel adhesive is a hydrogel or a hydrocolloid.

28. The system of claim 27, wherein the gel adhesive comprises a surface modifier.

29. The system of claim 27, wherein the surface modifier is an adhesion promoter, a depilatory agent, an antiperspirant, or an exfoliator.

30. A multilayered dressing assembly, comprising:

a hub having a manifold configured for connection with a fluid pathway connecting to an irrigation fluid source;

a sealing layer having a first surface and a second surface, the first surface being coupled to the hub, the second surface being attachable to skin located proximate a wound;

a netting layer coupled to the second surface of the sealing layer; and

an irrigation network coupled to the netting layer.