Granted Patent B2

US 12,364,625 · App. 16/811,937 · Granted Jul 22, 2025

Inventors: Michael Simms Shuler (Athens, GA); Lars Runquist (Inver Grove Heights, MN); Alan Carlson (St. Paul, MN); Evan Leingang (Plymouth, MN)

Assignee: J&M Shuler Medical, Inc.

A61F13/05A61M1/77A61M1/915A61M1/92

Abstract

Claims (41)

1. A multilayered dressing system for negative pressure wound therapy, the system 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; and

a dressing configured to be positioned within a wound, the dressing comprising:

a sealing layer comprising a film having a first surface comprising a proximal surface of the sealing layer and a second surface opposite the first surface, the second surface comprising a gel adhesive disposed at one or more peripheral locations on the film, the sealing layer defining at least one opening through the sealing layer;

an irrigation layer including a plurality of irrigation flow paths in fluid communication with the first fluid pathway, the plurality of irrigation flow paths defining a central portion of the irrigation layer and a peripheral portion of the irrigation layer;

a separating layer positioned between the irrigation layer and the sealing layer, the separating layer comprising a liquid impermeable body, the liquid impermeable body being sized to have an area covering a first region adjacent to the central portion such that the separating layer acts as a barrier configured to force fluid to flow from the first region to a second region adjacent to the peripheral portion;

at least one perforated layer coupled to the irrigation layer; and

a vacuum interface chamber positioned between the sealing layer and the irrigation layer, the vacuum interface chamber comprising a plurality of vacuum flow paths in fluid communication with the outflow line;

wherein the hub is configured to be positioned directly on the first surface of the sealing layer after the dressing is positioned within the wound, the hub configured to be aligned with the at least one opening defined by the sealing 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 an 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 4 , wherein the gel adhesive comprises a surface modifier.

6. The system of claim 5 , wherein the surface modifier is one of an adhesion promoter, a depilatory agent, an antiperspirant, and an exfoliator.

7. The system of claim 1 , wherein the at least one perforated layer comprises:

a first perforated layer coupled to the irrigation layer and defining a plurality of pores adapted to prevent tissue ingrowth; and

a second perforated layer coupled to the irrigation layer, such that the irrigation layer is positioned between the first perforated layer and the second perforated layer; and

wherein the first perforated layer and the second perforated layer are composed of silicone.

8. The system of claim 7 , wherein the first perforated layer and the second perforated layer each includes pores each having a diameter of about 0.5 millimeters (mm) to about 2 mm.

9. The system of claim 8 , 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.

10. The system of claim 7 , wherein the first perforated layer and the second perforated layer are positioned such that perforations in the first perforated layer are offset from perforations in the second perforated layer.

11. The system of claim 1 , wherein the sealing layer, the separating layer, and the irrigation layer are each sized according to a shape and a size of a wound area on which the multilayered dressing system is placed.

12. The system of claim 1 , wherein the irrigation layer includes a body portion and eight outwardly radiating irrigation flow paths extending from the body portion.

13. The system of claim 1 , wherein the irrigation layer includes two, three, four, five, six, seven, eight, nine, or ten irrigation flow paths.

14. The system of claim 1 , wherein the irrigation layer is composed of a polyurethane.

15. The system of claim 1 , wherein each irrigation flow path of the plurality of irrigation flow paths of the irrigation layer comprises two sealed edges that extend outwardly away from a lumen.

16. The system of claim 15 , wherein the two sealed edges of each irrigation flow path of the plurality of irrigation flow paths of the irrigation layer provide an attachment area for directly connecting the irrigation layer to at least another portion of the system.

17. The system of claim 1 , wherein the sealing layer comprises a backing configured to be removable from the hub.

18. The system of claim 1 , wherein the separating layer is further configured to force the fluid to flow from the peripheral portion of the irrigation layer toward the vacuum interface chamber.

19. 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; and

a dressing configured to be positioned within a wound, the dressing comprising:

a sealing layer having a first surface comprising a proximal surface of the sealing layer and a second surface opposite the first surface, the sealing layer defining at least one opening through the sealing layer;

an irrigation layer including a plurality of irrigation flow paths in fluid communication with the fluid pathway, each irrigation flow path of the plurality of irrigation flow paths defining a lumen that adjusts from a collapsed condition to an expanded condition when subjected to positive pressure, and the plurality of irrigation flow paths defining a central portion of the irrigation layer and a peripheral portion of the irrigation layer;

a separating layer coupled to (i) the second surface of the sealing layer, and (ii) the irrigation layer, the separating layer composed of a liquid impermeable body, the liquid impermeable body being sized to have an area covering a first region adjacent to the central portion such that the separating layer acts as a barrier configured to force fluid to flow from the first region to a second region adjacent to the peripheral portion;

at least one perforated layer coupled to the irrigation layer; and

a vacuum interface chamber positioned between the sealing layer and the irrigation layer;

wherein the hub is configured to be positioned directly on the first surface of the sealing layer after the dressing is positioned within the wound, the hub configured to be aligned with the at least one opening defined by the sealing layer.

20. The system of claim 19 , wherein the sealing layer comprises a backing configured to be removable from the hub.

21. The system of claim 19 , wherein the sealing layer includes a gel adhesive located along an outer perimeter of the second surface of the sealing layer, and wherein the gel adhesive is configured to form an air-tight seal over a wound area on which the multilayered dressing system is placed.

22. The system of claim 19 , wherein the at least one perforated layer defines multiple openings for the fluid to flow toward the hub.

Assignments (4)

Continuity (2)

References Cited (400)