Wound dressing for negative-pressure therapy

• US 8,926,574 B2
• Filed: 11/22/2011
• Issued: 01/06/2015
• Est. Priority Date: 11/25/2010
• Status: Expired due to Fees

• Current Assignee: Paul Hartmann AG (Schwenk Zement KG)
• Original Assignee: Paul Hartmann AG (Schwenk Zement KG)
• Inventors: Croizat, Pierre, Eckstein, Axel, Fink, Ulrich, Hofstetter, Jrgen
• Primary Examiner(s): HAND, MELANIE JO
• Application Number:
  US13/301,993
• Publication Number:
  US 20120136326A1
• Time in Patent Office: 1,141 Days
• Field of Search: 604/313, 604/319, 604/543, 602/41, 602/46, 602/47, 602 52- 55
• US Class Current: 604/313
• CPC Class Codes: A61F 13/00987 Apparatus or processes for manufacturing non-adhesive dressings or bandages
• CPC Class Codes: A61F 13/01017 synthetic, e.g. polymer based
• CPC Class Codes: A61F 13/022 having more than one layer with different fluid retention characteristics
• CPC Class Codes: A61F 13/0289 manufacturing of adhesive dressings
• 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: A61F 13/14 specially adapted for the breast or abdomen corsets or bandages for support of breast or abdomen A61F5/03
• CPC Class Codes: A61F 13/148 Abdomen bandages or bandaging garments
• CPC Class Codes: A61F 2013/00174 possibility of applying pressure
• CPC Class Codes: A61F 2013/00336 polymeric resins
• CPC Class Codes: A61F 2013/00536 for draining or irrigating wounds
• CPC Class Codes: A61F 2013/0054 for deep wounds
• CPC Class Codes: A61F 2013/00544 form or structure
• CPC Class Codes: A61F 2013/00855 pervious to air or vapours wound bandages in a special way pervious to air or vapour A61F2013/00246
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/916 specially adapted for deep wounds
• CPC Class Codes: A61M 1/918 for multiple suction locations
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2210/1017 Peritoneal cavity
• CPC Class Codes: A61M 2210/1021 Abdominal cavity
• CPC Class Codes: Y10T 29/49826 : Assembling or joining

Abstract

The present invention relates to a bandage for use in negative-pressure wound therapy, more particularly for wounds in the abdominal region, comprising a flexible film as a wound contact layer and at least one conduit applied to the film, wherein the conduit communicates with the wound space through openings in the conduit and in the film.

Claims

1. A wound dressing for use in negative-pressure wound therapy for treating abdominal wounds, comprising:

a first flexible film (1) having a first side and a second side, where the first side is intended for application onto the floor of the wound (13), onto exposed inner organs or onto the omentum majus, wherein

the wound dressing comprises at least one conduit (2) which is applied to the second side of the first film (1), said conduit (2) being fabricated from a pliable elastomeric material having a thickness (H) of not more than 30 mm,

where the conduit (2) is planar and is indissolubly and extensively bound to the second side of the first film (1) and comprises walls which define at least one continuous substantially rectangular hollow space (3) wherein the conduit (2) has a substantially rectangular cross section in which at least 90% of an area of a bottom surface of the conduit (2) projected perpendicularly onto the first film is indissolubly bound to the second side of the first film (1), said conduit (2) having a width and a length wherein the width is substantially uniform along substantially the entire length,

where both the conduit (2) and the first film (1) have a multiplicity of openings, so that a fluid connection can be established between the conduit (2) and the wound space, wherein at least some of openings (5) in the first film (I) and openings (22) in the conduit (2) overlap and are aligned with each other,

where there is a fluid-conducting connection between the conduit (2) and a negative-pressure source (21) by means of at least one terminal opening (23), and

where the wound dressing on the side facing away from the wound during use has at least one or more pockets (25) which are on the periphery and open toward the middle of the wound dressing and which have a depth of not more than 6 cm, and which facilitate uniform application and laying out the wound dressing onto the floor of the wound (13), wherein the pockets (25) each are formed by folding the first flexible film (1) or the combination of the first film (1) and a second film (4) and/or by applying further film pieces.

2. The wound dressing according to claim 1, wherein the conduit (2) is made of a material which has a Shore A hardness of not more than 60.

3. The wound dressing according to claim 1, wherein the conduit (2) is a drainage tube for medical purposes, and wherein the drainage tube comprises a polymer selected from the group consisting of NJ, PVC, PE, PET, PTFE, silicone and mixtures thereof.

4. The wound dressing according to claim 1, wherein the openings are holes and wherein the sum of the open areas of the holes of the first film (1) is at least 0.1% and not more than 20% of the areal extent of the film.

5. The wound dressing according to claim 1, wherein at least three conduits (2) are applied to the second side of the first film (1), and wherein the conduits (2) are applied in a radial arrangement or in a parallel arrangement.

6. The wound dressing according to claim 1, further comprising a second flexible film (4), wherein the second film (4) is applied to the side of the combination of first film (1) and conduit (2) facing away from the wound during use.

7. The wound dressing according to claim 6, wherein the second film (4) has a multiplicity of openings distributed over the surface which are suitable for conducting fluid.

8. The wound dressing according to claim 7, wherein the openings (5, 6) present in the first film (1) and the openings present in the second film are arranged such that the openings do not substantially overlap with one another.

9. The wound dressing according to claim 6, wherein the second film is substantially fluid impermeable and has only a single opening (10) arranged in the central area.

10. The wound dressing according to claim 1, wherein the first flexible film (1) and/or—

if present—

the second flexible film (4) is a thermoplastic film for medical purposes selected from the group consisting of PU, PE, PET, PVC, silicone and mixtures thereof.

11. The wound dressing according to claim 6, wherein the second flexible film (4)

a) is indissolubly bound, at least in places, to the at least one conduit (2), and/or

b) is indissolubly bound, at least in places, to the first flexible film (1).

12. The wound dressing according claim 1, further comprising a conduit plate (8) which is applied to the second side of the first flexible film (1) and is fastened at one or both of two ends of the at least one conduit (2).

13. The wound dressing according to claim 12, wherein the conduit plate (8) is in the form of a planar socket having an inner hollow space (24), and wherein, in addition, the end(s) of the at least one conduit (2) can be introduced such that a fluid connection can be established between the lumina (3) of the conduit (2) and the hollow space of the conduit plate (24).

14. The wound dressing according to claim 1, further comprising one or more liquid-permeable layers (11) for application onto the side of the wound dressing facing away from the wound during use.

15. The wound dressing according to claim 14, wherein the liquid-permeable layer (11) comprises a porous polymer foam material selected from the group consisting of PU, PVA and silicone.

16. The wound dressing according to claim 1, further comprising an air-impermeable covering material (16) for air-tight closure of the wound and of the wound surroundings, wherein the covering material (16) has an adhesive edge.

17. The wound dressing according to claim 16, further comprising a device (18) applied to the air-impermeable covering material (16) on the side facing away from the wound, said device being a negative-pressure connecting piece (port) for functional connection of the wound space to a negative-pressure source (21) located outside the covering material (16), so that negative pressure is established in the wound space and liquids are sucked off from the wound space.

18. A ready-to-use set for negative-pressure wound treatment, more particularly for treating abdominal wounds, comprising:

a) a wound dressing according to claim 1;

b) at least one liquid-permeable layer (11) for application onto the side of the wound dressing facing away from the wound during use, wherein the at least one liquid-permeable layer (11) comprises one or more flat pads consisting of a porous polymer foam material selected from the group consisting of PU, PVA and silicone;

c) an air-impermeable covering material (16) for air-tight closure of the wound and of the wound surroundings, wherein the covering material (16) has an adhesive edge; and

d) a negative-pressure connector (18) for functional connection of the wound space to a negative-pressure source (21) located outside the covering material, so that negative pressure is established in the wound space and liquids are sucked off from the wound space, wherein the negative-pressure connector (18) is intended for attachment onto the external side of the covering material facing away from the wound during use;

and wherein all of components a) to d) are each individually sterile packed.

19. A process for producing a wound dressing according to claim 1, comprising the steps of:

a) providing a first flexible film (1) having a first side and a second side, wherein the first side is intended for application onto the floor of the wound (13) onto exposed inner organs or onto the omentum majus, and wherein the film (1) has a multiplicity of openings (6) distributed over the surface;

b) providing at least one conduit (2) consisting of a pliable elastomeric material having a Shore A hardness of not more than 60 and a thickness (H) of not more than 30 mm, wherein the conduit (2) has at least one continuous hollow space (lumen) (3), and wherein the at least one conduit (2) has in addition a multiplicity of openings (22); and

,

c) applying the at least one conduit (2) to the second side of the first film (1).

20. A process for producing a wound dressing according to claim 6, comprising the steps of:

a) providing a first flexible film (1) having a first side and a second side, wherein the first side is intended for application onto the floor of the wound (13) onto exposed inner organs or omentum majus, and wherein the film (1) has a multiplicity of openings (5, 6) distributed over the surface;

b) providing a combination of at least three conduit elements (2) which are connected by a conduit plate (8), wherein the conduits (2) consist of a pliable elastomeric material having a Shore A hardness of not more than 60 and a thickness (H) of not more than 30 mm, and wherein the conduit (2) has at least one continuous hollow space (3), and wherein the conduit has in addition a multiplicity of openings (22);

c) applying the combination of conduits (2) and conduit plate (8) to the first film (1); and

,

d) applying a second flexible film (4) to the combination of first it (1), conduits (2) and conduit plate (8), wherein the second film is applied to the side of the combination pointing away from the wound during use.