WOUND DRESSING WITH INFLATABLE STRUCTURES
20190184075 · 2019-06-20
Inventors
Cpc classification
A61M1/915
HUMAN NECESSITIES
A61F13/05
HUMAN NECESSITIES
International classification
A61M1/00
HUMAN NECESSITIES
Abstract
Disclosed is a contact layer for a negative pressure wound treatment system, in which the contact layer includes as inflatable channel with an opening for inflation or deflation of a fluid. The contact layer is flexible to be kept close to the intestines and to be possible to wrinkle or fold it in order to fit into the wound. To keep it in the desired position once this is achieved since the contact layer is thin and lacks rigidity and stability and may thus easily be dislocated, the contact layer allows the inflatable channel to be in an uninflated, or slightly inflated, state from the start to be able to easily wrinkle and fold the contact layer first and thereafter, during or after placing the contact layer in position, inflating the channel to increase the rigidity and stability to help to keep the contact layer in its desired position.
Claims
1-16 (canceled)
17. A contact layer (16) for a negative pressure wound treatment system (10) in which said contact layer (16) is adapted to be located between a wound floor (12) and the skin, said contact layer (16) comprising at least one inflatable channel (102, 102a, 102b, 102c, 102d, 102e) which is provided with an opening (104) for inflation or deflation of fluid, wherein said contact layer (16) is liquid permeable.
18. The contact layer (16) according to claim 17, wherein the contact layer comprises at least four inflatable channels.
19. The contact layer (16) according to claim 18, wherein at least some of said inflatable channels (102, 102a, 102b, 102c, 102d, 102e) are designed as oblong channels stretching from the centre portion (108) of the contact layer (16) towards the edges (40) of the contact layer (16).
20. The contact layer (16) according to claim 18, wherein at least some of said inflatable channels (102, 102a, 102b, 102c, 102d, 102e) are designed as circular, oval or asymmetrical channels being circumferentially located around the centre portion (108) of the contact layer (16).
21. The contact layer (16) according to claim 18, wherein all channels (102, 102a, 102b, 102c, 102d, 102e) are connected by communicating conduits and all channels may be (102, 102a, 102b, 102c, 102d, 102e) inflated by introducing fluid through one single opening (104).
22. The contact layer (16) according to claim 18, wherein said channels (102, 102a, 102b, 102c, 102d, 102e ) form groups of channels (102a, 102b, 102c, 102d, 102e) such that the channels in each group are connected by communicating conduits and each group of channels may be separately inflated.
23. The contact layer (16) according to claim 22, wherein a first group of channels (102b) is formed on a first half portion of the contact layer and a second group of channels (102c) is formed on a second half portion, each group of channels on each half portion thus being separately inflated.
24. The contact layer (16) according to claim 17 wherein said contact layer (16) comprising one single inflatable channel (102, 102a, 102b, 102c, 102d, 102e).
25. The contact layer (16) according to claim 17, wherein said contact layer (16) is adapted for use with abdominal wounds and form part of a negative pressure therapy system.
26. The contact layer (16) according to claim 17, wherein said contact layer (16) comprises a top sheet (30) and a bottom sheet (32) and a plurality of inflatable channels (28) located there between.
27. The contact layer (16) according to claim 17, wherein the contact layer comprises sealed chambers (28).
28. A negative pressure abdominal wound treatment system kit, said kit comprising a contact layer (16) according to claim 17, said kit further comprising a wound filler (18) and a wound cover membrane (20), said contact layer (16) being adapted to be applied to a wound floor (12) of said abdominal wound.
29. The contact layer according to claim 19, wherein at least some of said inflatable channels are designed as circular, oval or asymmetrical channels being circumferentially located around the centre portion of the contact layer.
30. The contact layer according to claim 19, wherein all channels are connected by communicating conduits and all channels may be inflated by introducing fluid through one single opening.
31. The contact layer according to claim 20, wherein all channels are connected by communicating conduits and all channels may be inflated by introducing fluid through one single opening.
32. The contact layer according to claim 19, wherein said channels form groups of channels such that the channels in each group are connected by communicating conduits and each group of channels may be separately inflated.
33. The contact layer according to claim 20, wherein said channels form groups of channels such that the channels in each group are connected by communicating conduits and each group of channels may be separately inflated.
34. The contact layer according to claim 18, wherein said contact layer is adapted for use with abdominal wounds and form part of a negative pressure therapy system.
35. The contact layer according to claim 19, wherein said contact layer is adapted for use with abdominal wounds and form part of a negative pressure therapy system.
36. The contact layer according to claim 20, wherein said contact layer is adapted for use with abdominal wounds and form part of a negative pressure therapy system.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] The present invention will be explained below by means of non-limiting examples with reference to the accompanying drawings, in which:
[0034]
[0035]
[0036]
[0037]
[0038]
[0039]
DETAILED DESCRIPTION OF THE DRAWINGS
[0040] The invention will, in the following, be exemplified by embodiments. It is to be understood, however, that the embodiments are included in order to explain principles of the invention and not to limit the scope of the invention defined by the appended claims.
[0041]
[0042] The negative pressure wound therapy system 10 comprises an organ contact layer 16 at least a portion of which is adapted to be located between the wound floor 12 and the abdominal wall 14. Furthermore, the system 10 comprises a wound filler 18 adapted to provide fluid transport between the organ contact layer 16 and a negative pressure source 21. Purely by way of example, the wound filler 18 may comprise a foam material, for instance an open-celled foam material. As a non-limiting example, the wound filler 18 may comprise a flexible open-celled foam material, such as a sponge material. Examples of suitable foam materials include, without limitation, materials comprising polyurethane, polyester, polyether or polyvinyl alcohol or combinations thereof. As a non-limiting example, the foam may be a hydrophobic polymer foam. As another non-limiting example, the wound filler 18 may comprise gauze.
[0043] Moreover, although purely by way of example, the negative pressure source 21 may comprise a negative pressure pump which may be referred to as a vacuum pump. Purely by way of example, the negative pressure source 21 may be adapted to provide a negative pressure, the absolute value of which is greater than or equal to a threshold value. Generally, the threshold value in such embodiments is at least 20 mmHg. In some embodiments, the negative pressure source 21 is adapted to provide negative pressure at one fixed threshold value.
[0044] The negative pressure wound therapy system 10 further comprises a wound cover membrane 20. The wound cover membrane is generally adapted to be attached to the skin surrounding the wound. Purely by way of example, the wound cover membrane 20 may comprise a wound cover film. The wound cover membrane 20 may preferably be attached to the skin surrounding the abdominal wound, for instance by means of an adhesive. Examples of adhesives that may be used include, but are not limited to, acrylic adhesives and/or silicone gel adhesives. In some embodiments, the adhesive or adhesives is/are already incorporated as part of the wound cover film. In some embodiments, the adhesive or adhesives is/are applied to the wound cover member during use. Purely by way of example, the adhesive sold under the trademark Mepiseal by Molnlycke Healthcare AB may be used for attaching the wound cover member to the skin surrounding the wound membrane during use.
[0045]
[0046] Arrows in
[0047] The negative pressure wound therapy system 10 described in
[0048]
[0049] The organ contact layer 16 has a planar extension in a first plane defined by the X- and Y-axis. In this case is the organ contact layer exemplified by a thin sheet 100. The thin sheet 100 is provided with a plurality of inflatable channels 102 (only one channel disclosed in the portion shown in
[0050] Each one of the channels 102 is provided with at least one opening 104 in order to be inflated. The openings 104 may be connected via linking conduits 106 to a source (not shown) for filling and inflating of the channels 102. As a source for filling the channels 102, linking conduits 106 or chambers 110 may be used (purely as an example) a syringe filled with fluid. The linking conduit for filling (which may have a diameter/width/height that is smaller, equal to or larger than the channels) may be directly connected to the channels or to a common chamber or several connected channels. For example, all or a group of channels 102 may have their linking conduits 106 connected to a common chamber or some kind of manifold such that each one of the channels 102 is directly connected to the common chamber. This chamber is thus adapted to be connected to a fluid source in order to be filled with a fluid and delivering the fluid to the respective channels 102 via their linking conduits 106 or by being directly in contact with the opening 104 of the channels. Alternatively, all or some of the channels 102 may be connected in series such that the filling fluid will pass through one or more channels 102 in order to fill up further channels, which shall be inflated from the source. In this figure, i.e.
[0051] The channels 102 may vary in size from being about 40 millimetres to 800 millimetres long and having a width of 1 to 100 millimetres. The height is in a range from 1 to 40 millimetres. Most commonly the channels vary in size from being about 40 millimetres to 400 millimetres long and having a width of 3 to 25 millimetres and a height in a range from 3 to 25 millimetres. It is generally considered that the height and width are essentially of the same dimensions or that the width may be larger than the height even though this is not necessary. The height and/or the width may vary along the longitudinal extension or be the same. In case the height and width are of essentially the same dimensions the channels will assume an essentially circular cross sectional area, i.e. having an essentially cylindrical shape, when inflated with the filling fluid. In case the width is greater than the height will the cross sectional area be more oval. The geometrical shape may also have other geometries all though these geometrical shapes described above will be natural to form when the channels are filled and pressurized with fluid. The volume of a channel is generally thought to be in the range from 0.020 ml to 30 ml. A channel having a volume of 0.02 ml corresponds essentially to a cylindrical chamber having a diameter of 1 mm and being 25 millimetres long while 20 ml corresponds to a cylindrical channel having a diameter of 10 mm and a length of about 250 millimetres. A cylindrical shaped channel having a diameter of around 5 millimetres and being 100 millimetres long will thus have a volume of about 2 ml. The channels may be straight or curved. The thin sheet 100 may have a thickness within the range of 0.01-1 mm. The thickness of the sheet is generally thought to be 0.01-0.2 mm. The walls of the chambers may have the same thickness. In practice, the walls of the channels 102 are preferably made from the same kind of material as the thin sheet 100. The thin sheet 100 and the chambers 102 may be made of plastics which may comprise polyurethane.
[0052] In
[0053] In
[0054] The distinction between what is referred to as a channel 102, a linking conduit 106 and a chamber 110 is mainly defined by its function. All these features represent spaces which are intended to be filled up with a fluid entering the system from the injection conduit 112.
[0055] However, the inflatable features have been defined herein with respect to their intended main function. Features referred to as a channel 102 are features that are designed to provide stability and rigidity to the organ contact layer 16. Elements referred to as linking conduits 106 are features that are designed to enable transport of the fluid between channels 102, between a channel 102 and a chamber 110 or between chambers 110. Elements referred to as chambers 110 are features that are designed to receive fluid and distribute the fluid to a multitude of channels 102, either by being in direct contact with an opening 104 in a connected channel 102 or via a linking conduit 106. A space may have one, two or all three of these functions, but are in this context referred to by their main function.
[0056] In
[0057] In
[0058] In
[0059] In
[0060] In
[0061] One should note that only the main characteristics have been discussed concerning these examples of an organ contact layer. For example, all the above described organ contact layer may be made liquid permeable by providing slits or holes in the sheet. There may of course be further channels included in the contact layer and the layout and design could also be different. In the examples above is only disclosed that one channel, all channels, 2 groups or 3 or a larger number of groups of channels will be filled at the same time. It could of course be possible to group the channels as desired and use more groups or even have each channel being independently controlled to be filled. Hence, all these embodiments only show a few examples of possible configurations and arrangement of inflatable channels in an organ contact layer.
[0062] All the above designs can be achieved by using a single thin sheet 100 or a top sheet and a bottom sheet and having the channels 102 interposed between these sheets. All the above designs could also be used in a single sheet with the channels 102 welded to this sheet 100. This design could for example be used for integrating the channels 100 in an organ contact layer as disclosed in WO 2014/202560, which hereby is incorporated by reference, and will be described next with reference to
[0063] In
[0064] Purely by way of example, each one of the sealed chambers encloses a volume of at least 0.010 ml. Alternatively, each one of the sealed chambers encloses a volume of at least 0.050 ml. As another non-limiting option, each one of the sealed chambers encloses a volume of at least 0.080 ml.
[0065] In other non-limiting examples of a sealed chamber, the sealed chamber may have a substantially cylindrical shape with a height, i.e. an extension in a direction perpendicular to the planar extension of the top sheet 30 and/or the bottom sheet 32, and a diameter in the planar extension. Purely by way of example, the height of a sealed chamber may be within the range of 0.3-0.7 of the diameter of the sealed chamber. The channels 102 may be of the dimensions earlier discussed and the sealed chambers 28 and the channels 102 may be adapted to each other such that they have equal height.
[0066] Purely by way of example, the sealed chamber may have a diameter that is one of the following: 3, 6, 9 or 25 mm. Assuming, as a non-limiting example, that the height of the sealed chamber is approximately half the diameter of the sealed chamber, the volume of the sealed chamber is approximately 0.010 ml for a sealed chamber with a diameter of 3 mm, approximately 0.080 ml for a sealed chamber with a diameter of 6 mm, approximately 0.28 ml for a sealed chamber with a diameter of 9 mm and approximately 6.0 ml for a sealed chamber with a diameter of 25 mm.
[0067] As a non-limiting example, the intermediate sheet 34 may be of a plastics material which may comprise polyurethane. Instead of, or in addition to polyurethane, at least one, alternatively two or more, of the top, bottom and intermediate sheets 30, 32, 34 may comprise at least one of the following materials: other types of urethanes, silicone, transparent hydrocolloid, PVC, hydrogel, copolyester, polyethylene, TPS (thermoplastic elastomers based on styrene) or TPO (thermoplastic olefins) i.e. blends of polyethylene and polypropylene.
[0068] Purely by way of example, each one of the top and bottom sheets 30, 32 as well as the intermediate sheet 34 may have a thickness within the range of 0.01-1 mm.
[0069] In a specific embodiment could the contact layer 16 be manufactured such that it essentially only has what appears to be sealed chambers 28 when the dressing 16 is manufactured. There are however a few chambers 28 which has been adapted with an inlet opening 104, either being void or having a one-way valve at the inlet opening. The contact layer could be manufactured such that a group of sealed chambers 28 have been prepared to release the attachment of intermediate walls when subjected to an elevated pressure. This design could thus enable a contact layer 16 which appears only to have a multitude of small sealed chambers 28 to form larger channels 102 by injecting a fluid into these special chambers 28 which is adjacent to a group of sealed chambers which are designed such that their intermediate walls will collapse and they will form a large channel together when fluid is injected. The collapse may for example be made, if a design using a top sheet 30, bottom sheet 32 and intermediate sheet 34, by designing the intermediate sheet 34 to have a weaker attachment to the top sheet 30 and/or bottom sheet 32 at predefined locations such that it will detach in a controlled manner and a group of sealed chambers will form an inflatable channel.)
[0070]
[0071] If this layout described in
[0072] In