Wound dressing for negative-pressure therapy
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.
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.