Sub-atmospheric wound therapy systems and methods

• US 10,583,228 B2
• Filed: 07/28/2015
• Issued: 03/10/2020
• Est. Priority Date: 07/28/2015
• Status: Active Grant

• Current Assignee: J & M Shuler Medical, Inc.
• Original Assignee: J&m Shuler, Inc.
• Inventors: Shuler, Michael Simms, Runquist, Lars, Carlson, Alan, Leingang, Evan
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Lalonde, Alexandra
• Application Number:
  US14/811,104
• Publication Number:
  US 20170028113A1
• Time in Patent Office: 1,687 Days
• 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 vacuum interface chamber defining a lumen in fluid communication with the first fluid pathway, the vacuum interface chamber comprising a series of risers that provide structural support and define intermediate fluid pathways between the second fluid pathway and a plurality of pores facing radially outward from a side of the vacuum interface chamber;

a sealing layer positioned between the hub and the vacuum interface chamber, the 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 film of the sealing layer, the perforated layer defining a plurality of pores for fluid flow toward the vacuum interface chamber; 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 via the lumen of the vacuum interface chamber, each tube defining a lumen extending from the lumen of the vacuum interface chamber to a radially outer edge of the perforated layer.

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 perforated layer is composed of silicone.

6. The system of claim 1, wherein the perforated layer includes 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 one or more 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 each tube 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 of the at least one tube of the plurality of tubes 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 of the at least one tube of the plurality of tubes.

17. The system of claim 15, wherein the protrusions are located along a top portion or a bottom portion of the lumen of the at least one tube of the plurality of tubes.

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. The system of claim 1, wherein the plurality of pores are defined by a ventral floor of the vacuum interface chamber.

21. The system of claim 1, wherein the plurality of risers are configured to distribute a negative pressure from the outflow line.

22. A multilayered dressing assembly, comprising:

a hub having 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 vacuum interface chamber defining a lumen in fluid communication with the first fluid pathway, the vacuum interface chamber comprising a series of risers that provide structural support and define intermediate fluid pathways between the second fluid pathway and a plurality of pores facing radially outward from a side of the vacuum interface chamber;

a sealing layer positioned between the hub and the vacuum interface chamber, the 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.

23. The system of claim 22, wherein the gel adhesive is a hydrogel or a hydrocolloid.

24. The system of claim 23, wherein the gel adhesive comprises a surface modifier.

25. The system of claim 24, wherein the surface modifier is an adhesion promoter, a depilatory agent, an antiperspirant, or an exfoliator.