SELECTIVELY CONFIGURABLE WOUND DRESSING

Abstract

A wound dressing is selectively configurable for use in a pressure gradient wound therapy system and for use without a pressure gradient wound therapy system. The wound dressing can include a covering layer, an aperture and a base plate. the base plate can be configured to sealingly receive a connector part.

Claims

1. A one-piece wound dressing selectively configurable for use in a pressure gradient wound therapy system and for use without a pressure gradient wound therapy system; the wound dressing comprising; a wound contact layer having a first surface for contacting a wound and an opposing second surface; and a covering layer having a first surface facing the wound contact layer and defining a wound dressing cavity, and an opposing second surface; wherein the second surface of the covering layer comprises a planar base plate of a two-part port for connecting to a source of non-atmospheric pressure and configured to sealingly receive a connector part of the two-part port.

2. A wound dressing according to claim 1 wherein a body of the wound dressing comprises the wound contact layer, and the covering layer and the body of the wound dressing are provided as an integral item.

3. A wound dressing according to claim 2 wherein the integral item includes an adhesive layer.

4. A wound dressing according to claim 2 or 3 wherein the integral item includes a removeable release layer.

5. A wound dressing according to any preceding claim wherein the base plate is flexible.

6. A wound dressing according to any preceding claim wherein the base plate comprises a microbial barrier.

7. A wound dressing according to claim 6 wherein the microbial barrier is a mechanical valve.

8. A wound dressing according to any preceding claim wherein the covering layer comprises an aperture, the base plate surrounding the aperture, and wherein the aperture is covered by a microbial barrier.

9. A wound dressing according to any preceding claim wherein a pressure distribution layer is provided adjacent to the cover layer.

10. A wound dressing according to claim 2 wherein the adhesive layer is provided on the underside of the covering layer so as to form an adhesive border.

11. A wound dressing according to any preceding claims further comprising one or more absorbent layers in combination with a gel-forming fibre.

12. A wound dressing according to any preceding claim wherein the base plate comprises one or more projections for connecting the connector part to the base plate, wherein the projections are arranged adjacent the aperture.

13. A wound dressing according to claim 12 wherein the projections are configured to connect to the connector part by means of a snap fit.

14. A wound dressing according to any preceding claim wherein the base plate comprises a sealing element.

15. A selectively configurable wound dressing comprising a base plate of a two-part port according to any preceding claim; and a connector part of a two-part port.

16. A wound dressing according to claim 15 wherein the connector part comprises a tubing connection, the tubing connection being configured to receive a tube connected to a source of non-atmospheric pressure.

17. A wound dressing according to claim 16 wherein the connector part comprises a mechanical valve.

18. A kit of parts including a selectively configurable one-piece wound dressing according to claims 1 to 17; the kit further comprising at least one of: a. packaging indicating that the wound dressing is selectively configurable for use in a pressure gradient wound therapy system and without a pressure gradient wound therapy system; b. instructions instructing a user as to how to configure the wound dressing for use in a pressure gradient wound therapy system and for use without a pressure gradient wound therapy system; c. a piercing tool configured to pierce a covering layer of the wound dressing to produce an aperture therein and thereby configure the wound dressing for use in a pressure gradient wound therapy system; d. a source of non-atmospheric pressure; e. a connector part for connection to the base plate of the wound dressing to connect the wound dressing to a source of non-atmospheric pressure; or f. tubing for connection between a wound dressing and a source of non-atmospheric pressure; wherein the wound dressing comprises a wound contact layer and a covering layer, the covering layer having a first surface facing the wound contact layer and defining a wound dressing cavity, and a second surface; wherein the second surface of the covering layer comprises a planar base plate of a two-part port for connecting to a source of non-atmospheric pressure, configured to sealingly receive a connector part of the two-part port.

19. A method of configuring a selectively configurable one-piece wound dressing; the wound dressing being configurable for use in a pressure gradient wound therapy system and without a pressure gradient wound therapy system; the wound dressing comprising a covering layer, the covering layer comprising a base plate of a two-part port; the method comprising: configuring the wound dressing for use with a pressure gradient wound therapy system by connecting a connecting part of the two-part port to the base plate.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0093] In order that the invention may be more clearly understood one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, of which:

[0094] FIG. 1 is a schematic representation of an embodiment of a wound dressing configured for use without a wound therapy apparatus;

[0095] FIG. 2 is a schematic representation of the wound dressing of FIG. 1 configured for use with a wound therapy apparatus;

[0096] FIG. 3 is an isometric view of the unconnected port components of the wound dressings of FIGS. 1 and 6;

[0097] FIG. 4 is an isometric view of the connected port components of the wound dressings of FIGS. 2, 7 and 8;

[0098] FIG. 5 is a cross sectional view of the connected port components of FIG. 4;

[0099] FIG. 6 is an exploded view of a wound dressing according to another embodiment of the invention, configured for use without a wound therapy apparatus;

[0100] FIG. 7 is a cross sectional view through the wound dressing of FIG. 6, configured for use with a wound therapy apparatus;

[0101] FIG. 8 is a schematic representation of a wound exudate management system according to certain embodiments; and

[0102] FIG. 9 is a schematic representation of a kit of parts.

[0103] Embodiments disclosed herein relate to apparatus and methods of treating a wound both with and without reduced or positive pressure (typically negative pressure). Some embodiments including pump and wound dressing component. The wound dressings discussed are “one-piece” dressings incorporating both a covering layer and an absorbent body.

[0104] As disclosed herein the present invention may comprise a wound dressing; or a kit comprising the wound dressing and other apparatus for providing pressure gradient wound therapy to a wound.

[0105] As used herein the expression “wound” may include an injury to living tissue may be caused by a cut, blow, or other impact, typically one in which the skin is cut or broken. A wound may be a chronic or acute injury. Acute wounds occur as a result of surgery or trauma. They move through the stages of healing within a predicted timeframe. Chronic wounds typically begin as acute wounds. The acute wound can become a chronic wound when it does not follow the healing stages resulting in a lengthened recovery. It is believed that the transition from acute to chronic wound can be due to a patient being immuno compromised.

[0106] Chronic wounds may include for example: venous ulcers (such as those that occur in the legs), which account for the majority of chronic wounds and mostly affect the elderly, diabetic ulcers (for example, foot or ankle ulcers), peripheral arterial disease, pressure ulcers, or epidermolysis bullosa (EB).

[0107] Examples of other wounds include, but are not limited to, abdominal wounds or other large or incisional wounds (either as a result of surgery, trauma, stemiotomies, fasciotomies, or other conditions), dehisced wounds, acute wounds, chronic wounds, subacute and dehisced wounds, traumatic wounds (such as from orthopaedic trauma), flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stoma, surgical wounds, trauma and venous ulcers, broken bones or the like.

[0108] Wounds may also include a deep tissue injury. Deep tissue injury is a term proposed by the National Pressure Ulcer Advisory Panel (NPUAP) to describe a unique form of pressure ulcers. These ulcers have been described by clinicians for many years with terms such as purple pressure ulcers, ulcers that are likely to deteriorate and bruises on bony prominences.

[0109] The technology disclosed can be used on an acute or chronic wound.

[0110] Wounds are believed to be more susceptible to infection under the following circumstances. If the wounds are chronic wounds, or if an object which caused the wound was dirty or contained bacteria, or from a bite, or contains remnant or a whole object that caused the wound, or a wound that is large or deep, or jagged edges to the wound, or elderly, or chronic because by their nature a wound site is open; and/or if the patient has: diabetes type 1 or type 2, is elderly, or has a compromised immune system.

[0111] Pressure gradient wound therapy may also be useful for treating second- and third-degree burns, as well as being useful for laparotomy surgery i.e., a large incision through an abdominal wall to gain access into the abdominal cavity.

[0112] FIGS. 1 and 2 illustrate an embodiment of a wound dressing 10 in accordance with the invention in two different configurations.

[0113] In general, the invention relates to a wound dressing 10, which is selectively configurable for use without a pressure gradient wound therapy system or for use with a pressure gradient wound therapy system, e.g. negative pressure wound therapy and comprises a base plate 30 of a two-part port to enable connection of a source of non-atmospheric pressure for pressure gradient wound therapy, but can equally be used without a source of non-atmospheric pressure for “normal” wound therapy.

[0114] As shown in FIG. 1, the wound dressing 10 includes a covering layer 13 of the dressing 10. The covering layer 13 has a raised central region 14, where it overlies a dressing body, which can include a pressure dispersion layer; an absorbent/superabsorbent layer/layers; and a wound-contact layer. The dressing 10 also has a border region 15, where it overlies an adhesive layer. A removable release layer (not shown) is provided on the underside.

[0115] Arranged on the outer surface of the covering layer 13 is the base plate 30 (described in detail below); the base plate 30 is arranged towards the periphery of the raised central region 14.

[0116] FIG. 3 shows the base plate 30 and a connector part 40, which together make up a two-part port in an disassembled configuration. The connector base plate 30 is an annular, low profile thermoplastic plate having an aperture 36 in the center. The connector base plate 30 has a lower surface (not shown), which is adhered to the covering layer of wound dressing 30 (not shown in FIG. 3). Opposite the lower surface is an upper surface 37, the upper surface comprises three projections 38 arranged on an inner edge of the upper surface 37, the three projections 38 project perpendicular to the upper surface 37. The projections 38 are each provided with radially outwardly extending clips 31, which form a first part of a cantilever snap fitting, which is the exemplary means of connecting the connector base plate 30 and the connector part 40.

[0117] As shown in FIGS. 3 to 5 the connector part 40 comprises a dome shaped body 41 and a tubing connection 42 projecting from the edge of the hemispherical body 41. A conduit 44 is provided within the second port component 40 extending between an opening 43 on the tube connecting portion 42 (for connection to tubing (not shown) and the open underside 45 of a hemispherical cavity beneath the dome 41 (as shown in FIG. 5). The inner edge of the hemispherical cavity is configured to provide the second part of the cantilever snap fitting, and as such includes a circumferential recess 46 configured to receive the clips 31 of the projections 38 of the first part of the cantilever snap fitting.

[0118] As illustrated in FIG. 1, to use the wound dressing 10 without a pressure gradient wound therapy system, the release layer (not shown) on the underside of the dressing 10 is simply removed and the dressing 10 applied in the same way as an ordinary wound dressing.

[0119] FIG. 2 shows the wound dressing 10 configured for use with a pressure gradient wound therapy system. Here, the user has pierced the covering layer 13 in the region defined by the aperture 36 in the connector base plate 30 to form an aperture in the covering layer 13 and connected the connector part 40 to the base plate 30 by means for the snap fitting, so as to form an assembled port 50 (that is, the assembled port 50 comprises the connector base plate 30 and the second port component 40 as shown in FIG. 4). In this exemplary embodiment the user pierces the covering layer 13 with a scalpel (or alternatively scissors). When the user sealingly connects the base plate 30 to the connector part 40, such that the upper surface 37 of the base plate receives the underside of the connector part 40. The upper surface 37 of the base plate and underside of the connector part 40 form seal such that the assembled port 50 is configured to connect to a source of non-atmospheric, e.g. negative, pressure to the aperture without drawing in an excess of air at the interface of the base plate 30 and the connector part 40. The seal is preferably air tight, or at least substantially air-tight, so as to allow for the efficient supply of negative pressure to the wound dressing 10 to aid the wound-healing process. It will be appreciated by those skilled in the art that a completely air-tight seal is ideal, but with a sufficiently powerful pump, the seal need not be absolutely air-tight. In some embodiments the seal may be provided by the provision of a sealing element, such as an O-ring, arranged on one of the base plate or connector part. Those skilled in the art will appreciate that, as an alternative, the seal may be provided through the selection of materials and tolerances for the base plate 30 and connector part 40. As a consequence of the air tight nature of the seal between the base plate 30 and connector part 40, any excess extrudate being transferred from the wound dressing to a cannister will also be prevented from leaking from the assembled port.

[0120] The assembled port 50 can be connected via tubing (not shown in FIG. 2) to a pump (also not shown in FIG. 2) producing negative pressure. Those skilled in the art will appreciate that the steps to configure the wound dressing 10 for use with a pressure gradient wound therapy system can be undertaken either prior to or after the wound dressing 10 has been applied to the wound (i.e. the wound dressing can be configured for use with a pressure gradient wound therapy system in-situ).

[0121] For use where it is envisioned that a wound will initially require treatment with a pressure gradient wound therapy system, the wound dressing 10 may be configured for use with a source of non-atmospheric pressure (as outlined above) prior to removing the release layer and applying the wound dressing 10 to the wound; as such the assembly force as the connector part 40 is applied to the base plate 30 can take place away from the wound, before the dressing is applied.

[0122] Then, if/when the pressure gradient therapy is no longer necessary, the user can use up any remaining wound dressings 10 without the pressure gradient wound therapy system, by configuring the wound dressing 10 for use without a source of non-atmospheric pressure (as outlined above, simply applying the dressing to the wound without connecting the connector part 40 to the base plate 30).

[0123] On the other hand, for use where it is envisioned that a wound does not require treatment with a pressure gradient wound therapy system (and most preferably where it is envisioned that a wound does not require treatment with a pressure gradient wound therapy system, but it is considered that there is a risk that the wound will not heal well without a pressure gradient so in future, pressure gradient wound therapy might be useful), the user can apply the wound dressing 10 to the wound in the configuration for use without a pressure gradient wound therapy system. That is, remove the release layer and apply the wound dressing to the wound, so that the wound contact layer 330 covers the wound without connecting the connector part 40 to the base plate 30.

[0124] Then, should it be determined that the wound would benefit from pressure gradient therapy (e.g. negative pressure), the user can configure the wound dressing 10 in-situ, that is, connect connector part 40 to the base plate 30 and apply a source of non-atmospheric pressure as outlined above, without having first to remove the dressing 10 (which can present an opportunity for infection).

[0125] With reference to FIGS. 6 and 7, illustrated therein is a further exemplary embodiment of the present invention.

[0126] The illustrated wound dressing 300 generally includes a covering layer 310 and an adhesive layer 320 for adhering the wound dressing 300 adjacent the wound. In certain embodiments, the wound dressing 300 further comprises a wound contact layer 330 for contacting the wound, a pressure dispersion layer 340, a plurality of absorbent material layers 350 disposed between the wound contact layer 330 and the pressure dispersion layer 340.

[0127] The covering layer 310 has a first surface 311 and a second surface 312, and the first surface 311 is adjacent, and in contact with, the pressure dispersion layer 340 and the adhesive layer 320. The covering layer 310 defines a cavity in which the pressure dispersion layer 340 is arranged. In certain embodiments, the covering layer 310 is formed of a polyurethane film. The covering layer 310 comprises an aperture 314, providing fluid communication between the cavity and an environment external to the dressing. The aperture 314 arranged in the optimal position for connection to a source of negative pressure. The aperture 314 is surrounded by a base plate 30 of a two-part connector. The base plate 30 being of the same type as that described in the previous embodiment and being joined to the second surface 312 with an adhesive. In some embodiments, the aperture may be covered by a semi-permeable membrane, or a filter layer (not shown in FIGS. 6 and 7). The semi-permeable membrane or filter layer provide a microbial barrier to restrict or prevent the ingress on bacterial and/or viruses to the wound when the dressing is used without a pressure therapy system.

[0128] The adhesive layer 320 generally defines a border about an opening 322 for receiving the wound. In certain embodiments, the adhesive layer 320 comprises a silicone adhesive. In certain embodiments, the adhesive layer 320 may be perforated.

[0129] The wound contact layer 330 overlaps the border defined by the adhesive layer 320, and is configured to contact the wound via the opening 322. In certain embodiments, the wound contact layer 330 may comprise Medicel™. In certain embodiments, the wound contact layer 330 comprises carboxymethylated cellulose fibers. In certain embodiments, the wound contact layer 330 may comprise HYDROFIBER®. In certain embodiments, the wound contact layer 330 may be reinforced, for example via nylon stitching. Thus, the wound contact layer 330 may comprise reinforcing nylon stitching 332.

[0130] The pressure dispersion layer 340 is adjacent and in contact with the first surface 311 of the cover layer 310. In certain embodiments, the pressure dispersion layer 340 may be provided as a polyester foam layer. In certain embodiments, the pressure dispersion layer 340 comprises reticulated foam.

[0131] The absorbent material layers 350 are positioned between the wound contact layer 330 and the pressure dispersion layer 340. The wound dressing 300 may, for example, comprise eight absorbent material layers 350. In certain embodiments, one or more of the absorbent material layers 350 may comprise carboxymethylated cellulose fibers. In certain embodiments, one or more of the absorbent material layers 350 may comprise Medicel™. In certain embodiments, one or more of the absorbent material layers 350 may comprise HYDROFIBER®. In certain embodiments, one or more of the absorbent material layers 350 further comprises fenestrations 352.

[0132] In certain embodiments, as shown in FIG. 7, the wound dressing 300 may include an additional layer 370 between the pressure dispersion layer 330 and the uppermost absorbent layer 350. The additional layer 370 may, for example, be formed of thermoplastic. In certain embodiments, the additional layer 370 may be provided as a thermoplastic spun lace layer. In certain embodiments, the wound dressing 300 may further comprise a nonwoven spun lace layer 372 connected to the wound contact layer 330. In certain embodiments, an envelope structure 374 is formed by joining peripheral portions 373 of the thermoplastic spun lace layer 370 and the nonwoven spun lace layer 372 such that the plurality of absorbent material layers 350 are disposed substantially within an interior cavity 375 of the envelope structure 374. In certain embodiments, the absorbent material layers 350 are disposed within the interior cavity 375 of the envelope structure 374.

[0133] In certain embodiments, the wound dressing 300 may include a further layer 380 positioned between the wound contact layer 330 and the lowermost absorbent layer 350. The further layer 380 may, for example, be a polyester/viscose layer.

[0134] As is well known, and therefore not shown, the wound dressing 300 may be provided with a removable release layer on the underside, covering the adhesive layer 320 and the underside of the wound contact layer 330; and it may be individually packaged within a sterile package.

[0135] As illustrated in FIG. 6, the wound dressing 300 is configured for use without a pressure gradient wound therapy system. To use the wound dressing 300 without a pressure gradient wound therapy system, it is simply removed from its sterile packaging, then the release layer is simply removed and the dressing applied in the same way as an ordinary wound dressing.

[0136] FIG. 7 shows the wound dressing 300 of FIG. 6 configured for use with a pressure gradient wound therapy system. Here, a user has attached the connector part 40 of a two-part port to the base plate 30, by means of a snap fit attachment, to form an assembled port 50, the assembled port 50 of present invention being of the same type described in the previous embodiment.

[0137] It will be appreciated that the features of the wound dressing of either embodiment outlined above may be found in the wound dressing of the other embodiment. For example, the wound dressing 10 according to the first embodiment may have any or all of the layers of the wound dressing 300 according to the second embodiment; i.e. the wound dressing 10 may have one or more of the absorbent material layers as described, the wound dressing 10 may have one or more of the pressure distribution layers as described.

[0138] With additional reference to FIG. 8, illustrated therein is a pressure gradient wound therapy system 400 according to certain embodiments. The pressure gradient wound therapy system 400 comprises a pump 410 for generating negative pressure, a wound dressing 420 (which may be the wound dressing 10 or 300 described above) for covering and protecting a wound, an inline filter 430, a first pressure tube 440 having a first interior lumen 442, a second pressure tube 450 having a second interior lumen 452, and a two-part port 50. The first pressure tube 440 is disposed between the pump 410 and the inline filter 430. The second pressure tube 450 is disposed between the inline filter 430 and the port 50. The port 50 is disposed between the second pressure tube 450 and the wound dressing 420 such that the pump 410 and the wound dressing 420 are in fluid communication via the interior lumens 442, 452.

[0139] The wound dressings 10, 300, 420 may be provided in kits. As illustrated schematically in FIG. 9, the kits can comprise one or preferably more than one of the selectively configurable wound dressings 10, 300, 420 and at least one of the following items, all of which are included in this exemplary kit: [0140] (a) packaging 500 indicating that the wound dressing is selectively configurable for use in a pressure gradient wound therapy system and without a pressure gradient wound therapy system. In this example the packaging is a cardboard box, printed with instructions 501 for use. [0141] (b) instructions instructing a user as to how to configure the wound dressing for use in a pressure gradient wound therapy system and for use without a pressure gradient wound therapy system. In this example, the instructions are printed on a leaflet 502 included in the box. [0142] (c) a piercing tool configured to pierce a covering layer of the wound dressing to produce an aperture therein and thereby configure the wound dressing for use in a pressure gradient wound therapy system. In this embodiment, the piercing tool is again a scalpel 60. [0143] (d) a source of non-atmospheric pressure. In this embodiment, the source of non-atmospheric pressure is the pump 410. [0144] (e) a connector part for connection to the base plate of the wound dressing to connect the wound dressing to a source of non-atmospheric pressure. In this embodiment the connector part is the connector part 40 described above. [0145] (f) tubing for connection between a wound dressing and a source of non-atmospheric pressure. In this embodiment tubing 440 described above is included.

[0146] For use where it is envisioned that a wound will initially require treatment with a pressure gradient wound therapy system, the wound dressing 10 may be configured for use with a source of non-atmospheric pressure (as outlined above) prior to removing the release layer and applying the wound dressing 10 to the wound. The kit may comprise one or more preferably a plurality of, dressings 10/300/420 and one or more of items c, d, and e, for example all of items c, d and e, and optionally items a and/or b as well. As such, the user can be provided with all the equipment required to use the wound dressings 10/300/420 with a pressure gradient wound therapy system.

[0147] In order to use such a kit, the user (e.g. a patient or HCP) can cut an aperture in a dressing 10/300/420 in the region within the aperture 36 in the base plate 30; attach a connector part 40 thereto, around the aperture, and in fluid communication therewith; attach one end of the tubing 440 to the port 50 and the other to the pump 410 and run the pump 440 to provide non-atmospheric (e.g. negative) pressure to the wound.

[0148] Then, if/when the pressure gradient therapy is no longer necessary, the user can use up any remaining wound dressings 10 without the pressure gradient wound therapy system, by configuring the wound dressing 10 for use without a source of non-atmospheric pressure (as outlined above).

[0149] On the other hand, for use where it is envisioned that a wound does not require treatment with a pressure gradient wound therapy system (and most preferably where it is envisioned that a wound does not require treatment with a pressure gradient wound therapy system, but it is considered that there is a risk that the wound will not heal well without a pressure gradient so in future, pressure gradient wound therapy might be useful), the kit may comprise one, or more preferably a plurality of selectively configurable dressings 10/300/420 and one or both of items a and b. As such, the user has instructions on how to use the dressings without a pressure gradient wound therapy system and can simply apply a dressing 10/300/420 to the wound in the configuration for use without a pressure gradient wound therapy system. Thus the user can follow the instructions by removing the release layer and applying the dressing to the wound without connecting the connecting part 40 of the two-part port.

[0150] Then, should it be determined that the wound would benefit from pressure gradient therapy (e.g. negative pressure), the user can configure the wound dressing 10/300/420 in-situ, that is, follow the instructions from the packaging/instructions, to (optionally cut a hole in the covering layer 3 through the aperture 36 if using a wound dressing 10 according to he first embodiment; and) apply a connector part 40 of the two-part port to the base plate 30 and the other items of a pressure gradient wound therapy system as outlined above (sourced for example from another kit), without having to first remove the dressing 1/300/420 (which can present an opportunity for infection).

[0151] Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment.

[0152] Each of the documents referred to above is incorporated herein by reference. Except in Examples, or where otherwise explicitly indicated, all numerical quantities in this description specifying amounts of materials, device dimension, and the like, are to be understood as modified by the word “about.”

[0153] Unless otherwise indicated, each chemical or composition referred to herein should be interpreted as being a commercial grade material which may contain the isomers, by-products, derivatives, and other such materials which are normally understood to be present in the commercial grade.

[0154] The one or more embodiments are described above by way of example only. Many variations are possible without departing from the scope of protection afforded by the appended claims.