KIT FOR USE WITH A SELECTIVELY CONFIGURABLE WOUND DRESSING

Abstract

A packaged kit of parts is provided for use with a selectively configurable wound dressing. The kit includes 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. The kit may also include a) packaging indicating that the piercing tool is configured to pierce a covering layer of a wound dressing; (b) instructions instructing a user as to how to use the piecing tool; (c) one or more selectively configurable wound dressings; (d) a source of non-atmospheric pressure; (e) a port 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. The kit is arranged within a sealed package.

Claims

1. A packaged kit of parts for use with a selectively configurable 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 kit comprising: 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; and at least one of: a) packaging indicating that the piercing tool is configured to pierce a covering layer of a wound dressing to produce an aperture therein and thereby configure the wound dressing for use in a pressure gradient wound therapy; (b) instructions instructing a user as to how to use the piecing tool to configure a wound dressing for use in a pressure gradient wound therapy system; (c) one or more selectively configurable wound dressings, the wound dressings being configurable for use in a pressure gradient wound therapy system and without a pressure gradient wound therapy system; (d) a source of non-atmospheric pressure; (e) a port for connection to the covering layer 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; the kit being arranged within a sealed package.

2. A packaged kit of parts according to claim 1 wherein the piercing tool is provided in a sterile package.

3. A packaged kit of parts according to claim 1 or 2 wherein the piercing tool has a curved cutting edge.

4. A packaged kit of parts according to claim 3 wherein the piercing tool has a circular cutting edge.

5. A packaged kit of parts according to any preceding claim wherein the piercing tool comprises a cutting edge and a housing; the cutting edge being retractable into the housing.

6. A packaged kit of parts according to claim 5 wherein housing is a tubular housing; the cutting edge being retractable into the tubular housing.

7. A packaged kit of parts according to claim 5 or 6 wherein the piercing tool comprises an actuator, wherein actuation of the actuator moves the cutting edge to an extended position.

8. A packaged kit of parts according to any of claims 5 to 7 wherein the cutting edge is biased towards a retracted position.

9. A packaged kit of parts according to claim 8 wherein the bias is a spring-bias.

10. A packaged kit of parts according to claims 7 to 9 wherein the cutting edge is arranged to extend a predetermined extended distance from the housing in the extended position.

11. A packaged kit of parts according to claim 10 wherein the predetermined extended distance may is greater than 0.5 mm.

12. A packaged kit of parts according to claim 10 or 11 wherein the predetermined extended distance is less than 2.5 mm.

13. A packaged kit of parts according to any of claims 5-12 wherein the cutting edge is arranged to retract a predetermined retracted distance into the housing in the retracted position.

14. A packaged kit of parts according to claim 13 wherein the predetermined retracted distance is between 5 mm and 10 mm.

15. A packaged kit of parts according to any of claims 5-14 wherein the cutting edge is extendable from one end of the housing and the actuator is arranged at the opposite end of the housing, wherein the actuator moves the cutting edge to an extended position.

16. A packaged kit of parts according to any of claims 5-15 wherein the housing comprises an inwardly extending flange which acts as a guide for guiding the cutting edge.

17. A packaged kit of parts according to claim 16 when dependent on claim 9, wherein the flange supports a biasing spring for providing the spring bias.

18. A packaged kit of parts according to claim 7 or any of claims 8-14 when dependent directly or indirectly on claim 7, wherein the actuator comprises a support extending from a button.

19. A packaged kit of parts according to claim 18 when dependent on claim 16 or 17 wherein an outer peripheral surface of the support is guided by an inner edge of the flange and an outer peripheral surface of the button is guided by an inner tubular surface of the housing.

20. A packaged kit of parts according to any preceding claim including at least a) packaging indicating that the piercing tool is configured to pierce a covering layer of a wound dressing to produce an aperture therein and thereby configure the wound dressing for use in a pressure gradient wound therapy; the kit being arranged within a sealed package.

21. A packaged kit of parts according to any preceding claim including at least (b) instructions instructing a user as to how to use the piecing tool to configure a wound dressing for use in a pressure gradient wound therapy system; the kit being arranged within a sealed package.

22. A packaged kit of parts according to any preceding claim including at least (c) one or more selectively configurable wound dressings, the wound dressings being configurable for use in a pressure gradient wound therapy system and without a pressure gradient wound therapy system; the kit being arranged within a sealed package.

23. A packaged kit of parts according to any preceding claim including at least (d) a source of non-atmospheric pressure; the kit being arranged within a sealed package.

24. A packaged kit of parts according to any preceding claim including at least (e) a port for connection to the covering layer of the wound dressing to connect the wound dressing to a source of non-atmospheric pressure; the kit being arranged within a sealed package and the piercing tool being independent of the port.

25. A packaged kit of parts according to any preceding claim including at least (f) tubing for connection between a wound dressing and a source of non-atmospheric pressure; the kit being arranged within a sealed package.

26. A packaged kit of parts according to claim 22 wherein the dressing comprises a pressure distribution layer sandwiched between a covering layer and an absorbent layer, and the cutting edge is arranged to extend through the covering layer, to extend into the pressure distribution layer and not to extend into the absorbent layer.

27. A packaged kit of parts according to claim 22 or claim 26 wherein the 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 an indica, the indica denoting a suitable position in the covering layer to create an aperture to provide fluid communication between the wound dressing cavity and a source of non-atmospheric pressure; wherein the shape and/or size of the indicia matches the shape and/or size of the piercing tool.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0098] 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:

[0099] FIG. 1 is a schematic representation of an embodiment of a wound dressing configured for use without a wound therapy apparatus;

[0100] FIG. 2 is a schematic representation of the wound dressing of FIG. 1 configured for use with a wound therapy apparatus;

[0101] FIG. 3 is an exploded view of another embodiment of a wound dressing configured for use without a wound therapy apparatus;

[0102] FIG. 4 is a cross-sectional view of the wound dressing illustrated in FIG. 3;

[0103] FIG. 5 is a cross-sectional view of a portion of the wound dressing illustrated in FIG. 3;

[0104] FIG. 6 is an exploded view of the embodiment of the wound dressing of FIG. 3 configured for use with a pressure gradient wound therapy apparatus

[0105] FIG. 7a is a cross section through a piercing tool;

[0106] FIG. 7b is a cross section through the piercing tool of FIG. 7a in a piercing configuration;

[0107] FIG. 8 is an exploded view of the wound dressing of FIG. 6 in use with a pressure gradient wound therapy apparatus;

[0108] FIG. 9 is a cross-sectional view of the wound dressing of FIG. 4 in use with a pressure gradient wound therapy apparatus;

[0109] FIG. 10 is a schematic representation of a wound exudate management system according to certain embodiments; and

[0110] FIG. 11 is a schematic representation of a kit of parts.

[0111] 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.

[0112] As disclosed herein the present invention may comprise a piercing tool; or a kit comprising the piercing tool and other apparatus for providing pressure gradient wound therapy to a wound.

[0113] 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.

[0114] 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).

[0115] 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.

[0116] 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.

[0117] The technology disclosed can be used on an acute or chronic wound.

[0118] 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.

[0119] 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.

[0120] FIGS. 1 and 2 illustrates an embodiment of a wound dressing 1 for use in accordance with the invention in two different configurations.

[0121] In general, the invention relates to the piercing tool 20 (of FIGS. 7a and 7b) which is used in configuration of a wound dressing 1, the wound dressing 1 being 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.

[0122] As shown in FIG. 1, the wound dressing 1 includes an optional indicia 2 visible on the upper (outside) surface of a covering layer 3 of the dressing 1. The covering layer 3 has a raised central region 4, 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 1 also has a border region 5, where it overlies an adhesive layer. A removable release layer (not shown) is provided on the underside.

[0123] The indicia 2 indicates where the dressing should be cut to form an aperture in order to configure the dressing for use with a pressure gradient wound therapy system; the dressing being configured for use without a pressure gradient wound therapy system unless/until an aperture is cut in the covering layer. In this embodiment, the indicia 2 is shown as a circle formed in dashed lines, arranged in the optimal position for connection of a source of non-atmospheric pressure. Obviously in other embodiments alternative shapes/signs could be used and of course the indicia need not be in dashed lines.

[0124] Moreover it is contemplated that the piercing tool 20 may be used with dressings not having an indicia at all, with the user following instructions, in order to pierce the covering layer in a suitable location (e.g. the region shown by reference numeral 2).

[0125] As illustrated in FIG. 1, the wound dressing 1 is configured for use without a pressure gradient wound therapy system. To use the wound dressing 1 without a pressure gradient wound therapy system, the release layer is simply removed and the dressing applied in the same way as an ordinary wound dressing. It will be noted that the entire raised central region 4 of the covering layer 3 is a continuous unbroken membrane, uninterrupted and closed, so that the wound (within the region defined by the adhesive border) is in a sealed environment, restricting/preventing bacteria/microbes entering the wound and causing infection.

[0126] FIG. 2 shows the wound dressing 1 of FIG. 1 configured for use with a pressure gradient wound therapy system. Here, a user has cut through the cover layer 3 using the piercing tool 20 in the region of the indicia 2, to form an aperture 6 in the wound dressing 1 (so that the central region 4 is no longer closed/uninterrupted). With the wound dressing 1 now configured for use with a pressure gradient therapy system, a source of non-atmospheric, e.g. negative, pressure can be connected to the aperture 6 to aid the wound-healing process.

[0127] For example, a port (not shown in FIGS. 1 or 2) can be adhered to the wound dressing 1, such that a conduit through the port is aligned with the aperture 6; the port can be connected via tubing (also not shown in FIGS. 1 and 2) to a pump (also not shown in FIGS. 1 and 2) producing negative pressure.

[0128] The piercing tool 20 (best seen in FIGS. 7a and 7b) is specially configured to pierce the covering layer of a wound dressing, whilst not cutting too deeply into the dressing. The piercing tool 20 may be provided in a sterile package and as part of a kit, as discussed in more detail below, with reference to FIG. 11.

[0129] The piercing tool 20 of this embodiment is intended to cut a circular aperture, and therefore has a curved cutting edge 21, which defines a circle (to allow a circular aperture to be cut into the wound dressing, to match the shape of a port or airway to be attached over the dressing when connecting it to a source of non-atmospheric pressure).

[0130] The cutting edge 21 of this embodiment is provided at the end of a tubular support 22, the tubular support 22 being cylindrical and the edge formed by sharpening one end of the cylindrical tube. The tubular support 22 and cutting edge 21 can be formed from metal and may be considered similar to a circular metal pastry cutter, albeit smaller (typically between 15 mm and 25 mm, for example about 20 mm) and with a much sharper cutting edge, akin to a scalpel for example. In this way, the support 22 itself forms a blade, the blade having a cutting edge. In the alternative, the support 22 could carry a separate blade, the separate blade comprising the cutting edge. This would allow for the support to be integrated with other parts of the piercing tool (e.g. the button discussed below, formed for example from plastic).

[0131] The tubular support 22 of the embodiment is arranged within a housing 23. In such a way that the cutting edge can extend from a base of the housing 23 in use, and when not in use, is retracted into the housing 23.

[0132] The housing 23 of this embodiment is also tubular, with a wider diameter than the support 22 that it houses, and an inwardly extending flange 24 arranged approximately half-way along the length of the housing. The flange 24 is annular, with an inner diameter slightly larger than the outer diameter of the support 22, so as to act as a guide for the support 22 when the cutting edge 21 is moved between the extended and retracted positions. The outer peripheral surface of the support 22 is guided by the inner edge of the flange 24.

[0133] In order for a user to move the cutting edge 21 between the retracted and extended positions, the piercing tool 20 is provided with an actuator, which in this embodiment includes a circular button 25. The circular button 25 is arranged at the opposite end of the support 22 to the cutting edge 21. The circular button 25, may be formed integrally with the metal support 22 or formed separately, for example from plastic and attached to the support, e.g. by adhesive. The button 25, support 22 and tubular housing 23 are conveniently arranged coaxially/concentrically.

[0134] The button 25 of this embodiment of the invention has a larger periphery than the support 22, thus it closes one end of the tubular support 22 and extends beyond the outer periphery of the tubular support 22. At the periphery of the button, a downwardly extending lip 26 is provided. The outer peripheral surface of the button 25, i.e. that of the lip 26 is guided by the inner circumferential surface of the tubular housing 23, and in this embodiment, in the retracted position, the upper surface of the button 25 is aligned with the upper end of the tubular housing 23.

[0135] The size of the button 25 and the housing 23 are determined by the size of the cutting edge 21, which in turn is determined by the size of the aperture that it is desired to cut. So, for example, the button can have an outer diameter of 1-20 mm larger than the support, and the housing can have a diameter of 1-20 mm larger than the button. Thus, in this exemplary embodiment with a cutting edge of 20 mm, the diameter of the button may be 22 mm and the outer diameter of the housing may be 25 mm.

[0136] The cutting edge 21 is biased towards a retracted position, this is achieved by spring-loading the button 25 towards the retracted position using a compression spring 27 arranged within the housing between the actuator and the cutting edge 21. The compression spring 27 is affixed at one end to the topside of the flange and at its opposite end to the underside of the button 25.

[0137] A clip, retaining lug, or the like (not shown) between the support 22 and the flange 24, and/or between the button 25 and the housing 23 can be provided to prevent the actuator from falling out of the top of the housing 23 or the spring could be attached, e.g. glued to both the topside of the flange and the underside of the button to join the parts.

[0138] The length of the housing 23 relative to the support 22 determines the distance that the cutting edge 21 can be retracted into the housing when in the retracted position. As shown, when in the retracted position, the top surface of the button 25 and the housing 23 may be coplanar. This predetermined retracted position can be determined so as to ensure that the user is unlikely to cut themselves on the blade, and for example might be greater than 1 mm; greater than 1.5 mm; greater than 2 mm; greater than 2.5 mm; greater than 3 mm greater than 3.5 mm; greater than 4 mm or greater than 5 mm. The predetermined distance may be less than 15 mm; less than 12 mm; 10 mm; less than 7 mm; less than 5 mm; less than 4 mm; less than 3.5 mm; less than 3 mm; or less than 2.5 mm. For example, the predetermined distance may be between 5 mm and 10 mm, between 6 mm and 9 mm, for example about 7 mm. Providing the button 25 flush (or below) the top surface of the housing 23, helps prevent the button 25 being accidentally depressed.

[0139] The distance to which the cutting edge can extend is determined by the length of the support and the housing, and also the distance between the actuator and the flange 24 (and any space taken up by the compression spring 27).

[0140] It is important that this predetermined extended distance by which the cutting edge 21 extends from the base of the housing 23 is carefully controlled, so as to control how far into the wound dressing the cutting edge 21 extends.

[0141] As shown in FIG. 7b, in the extended position, the cutting edge 21 cuts right through the covering layer 3 of a wound dressing, but not into any layer beneath. Alternatively, for example, where the piercing tool is for use in a dressing with a pressure distribution layer sandwiched between a covering layer and an absorbent layer (as discussed below with reference to FIGS. 3-6) , the cutting edge 21 can be arranged to extend through the covering layer 310, to extend into the pressure distribution layer 340 and not to extend into the absorbent layer(s) 350 (or the wound contact layer 330).

[0142] This means that fluid can pass through the aperture cut into the covering layer, whilst not cutting too deeply into the body of the dressing, so as to reduce damage to internal parts of the dressing, such as a pressure distribution layer, or an absorbent layer.

[0143] As an example, the predetermined extended distance may be greater than 0.2 mm; greater than 0.5 mm; greater than 1 mm; greater than 1.5 mm; greater than 2 mm; greater than 2.5 mm; greater than 3 mm or greater than 3.5 mm. The predetermined distance may be less than 10 mm; less than 7 mm; less than 5 mm; less than 4 mm; less than 3.5 mm; less than 3 mm; less than 2.5 mm; or less than 1 mm. For example, the predetermined distance may be between 0.5 mm and 2.5 mm, such as between 1 mm and 2 mm, for example about 1.5 mm.

[0144] Balancing the distance by which the cutting edge extends against the distance by which it retracts, produces a compact bespoke piercing tool that is perfectly suited to its purpose of cutting an aperture into the covering layer of one-piece wound dressing, so as to change its configuration from being (only) suitable and intended for use without a pressure gradient wound treatment system, to being (only) suitable and intended for use in a pressure gradient wound treatment system.

[0145] With additional reference to FIGS. 3-4, illustrated therein is a schematic of another exemplary wound dressing 300 that can be selectively configured for use in a pressure gradient wound treatment system, using the piercing tool 20.

[0146] 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.

[0147] 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 indicia 314 again in the form of a dashed circle, arranged in the optimal position for connection to a source of negative pressure.

[0148] The polyurethane film is transparent, so the indicia can be printed on the inside first surface 311 or the outside, second, surface 312 of the film layer 310.

[0149] 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.

[0150] 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.

[0151] The pressure dispersion layer 340 is adj acent 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.

[0152] 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.

[0153] In certain embodiments, as shown in FIG. 4, 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, for example as illustrated in FIG. 5. In certain embodiments, the absorbent material layers 350 are disposed within the interior cavity 375 of the envelope structure 374.

[0154] 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.

[0155] 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.

[0156] As illustrated in FIGS. 3-5, the wound dressing 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. Again, it will be noted that in this configuration the entire region of the covering layer 310 within the peripheral adhesive border defined by the layer 320 is uninterrupted and closed, sealing the wound against microbes/bacteria that could cause infection.

[0157] FIG. 6 shows the wound dressing 1 of FIGS. 3-5 configured for use with a pressure gradient wound therapy system. Here, a user has cut through the cover layer 310 using the piercing tool 20. To cut through the covering layer 310, the user arranges the base of the housing 23 on the covering layer 310 of the dressing 300 in the region of the indicia 314. In this embodiment, the base of the housing 23 and the indica 314 have the same circular shape and size, so the user can align the piercing tool 20 in the optimal position on the dressing 300.

[0158] The user then presses down on the upper surface of the button 25. This causes the support to move downward, against the bias of the spring 27, extending the cutting edge 21 out of the base of the housing 23 to cut into the covering layer. Continued pressing brings the lip 26 of the button 25 into abutment with the upper surface of the flange 24, preventing the cutting edge from extending more than a predetermined distance out of the base of the housing. This ensures that the cutting edge extends right through the covering layer 310 and slightly into the pressure distribution layer 340, but not into the layers beneath.

[0159] The button 25 is then released and the compression spring 27 returns, biasing the actuator back to the rest position, with the cutting edge in a retracted position. The tool 20 can then be removed from the dressing and might carry with it a circular chad cut from the covering layer 310. Typically however, the chad will remain in the aperture and can be peeled out by a user to leave an aperture as shown in FIG. 6.

[0160] As such, the region of the covering layer 310 within the peripheral adhesive border defined by the layer 320 is now interrupted by the aperture 306, which forms an opening.

[0161] Next, and as shown in FIGS. 8 and 9, a port 307 is adhered to the outside, second surface 312 of the cover layer 310. An adhesive ring 366 attaches the port 307 to form a seal between one end 361 of the tube 360 and the port 307. The opposite end 362 of the tube 360 may be connected with a fitting such as a Luer lock 364.

[0162] With additional reference to FIG. 10, 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 1 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 flexible connector 460. 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 flexible connector (or port) 460. The flexible connector 460 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.

[0163] The piercing tool is preferably provided in a kit and most preferably arranged in the kit within a sterile package. As illustrated schematically in FIG. 11, the kits can comprise a piercing tool 20 within a sterile package 28 and at least one of the following items, all of which are included in this exemplary kit: [0164] (a) packaging 500 indicating that the piercing tool is configured to pierce a covering layer of a wound dressing to produce an aperture therein and thereby configure the wound dressing for use in a pressure gradient wound therapy. In this example the packaging is a cardboard box, printed with instructions for use. [0165] (b) instructions instructing a user as to how to use the piecing tool to configure a wound dressing for use in a pressure gradient wound therapy system. In this example, the instructions are printed on a leaflet 502 included in the box. [0166] (c) one or more selectively configurable wound dressings 1, 300, 420, the wound dressings 1, 300, 420 being configurable for use in a pressure gradient wound therapy system and without a pressure gradient wound therapy system. In this embodiment, a plurality of such wound dressings 1, 300, 420 are provided, each in individual sterile packages. [0167] (d) a source of non-atmospheric pressure. In this embodiment, the source of non-atmospheric pressure is the pump 410. [0168] (e) a port for connection to the covering layer of the wound dressing to connect the wound dressing to a source of non-atmospheric pressure. In this embodiment the port is the port 307 described above. [0169] (f) tubing for connection between a wound dressing and a source of non-atmospheric pressure. In this embodiment tubing 440 described above is included.

[0170] For use where it is envisioned that a wound will initially require treatment with a pressure gradient wound therapy system, the kit may comprise a piercing tool 20 and one or more of items d, e and f, for example all of items, d, e and f, and optionally items a and/or b and/or c as well. As such, the user can be provided with all the equipment required to use the wound dressings 1/300/420 with a pressure gradient wound therapy system.

[0171] In order to use such a kit, the user (e.g. a patient or HCP) can cut an aperture in a dressing 1/300/420, optionally in the region of indica, using the piercing tool 20; attach a port 307 thereto, around the aperture, and in fluid communication therewith; attach one end of the tubing 440 to the port 307 and the other to the pump 410 and run the pump 440 to provide non-atmospheric (e.g. negative) pressure to the wound.

[0172] Then, if/when the pressure gradient therapy is no longer necessary, the user can use up any remaining wound dressings 1/300/420 without the pressure gradient wound therapy system, by applying them to the wound without cutting an aperture in the dressings 1/300/420, so as to maintain a sealed environment around the wound.

[0173] On the other hand, for use where it is envisioned that a wound does not initially 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 the piercing tool 20, one or preferably a plurality of the dressings of item c, and preferably one or both of items a and b. As such, the user has the dressings which can be used without a pressure gradient wound therapy system and can simply apply a dressing 1/300/420 to the wound in the configuration for use without a pressure gradient wound therapy system. Thus the user simply remove the release layer and apply the dressing to the wound without cutting an aperture in the region of the indicia 2, 314, so that the cover layer is uninterrupted and closed within the adhesive border, and the is wound sealed against bacteria/microbes.

[0174] Then, should it be determined that the wound would benefit from pressure gradient therapy (e.g. negative pressure), the user can follow the instructions from the packaging/instructions (where included), and cut a hole in the covering layer 3/310 in the region of the indicia 2/314 using the piercing tool 20 and apply 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).

[0175] For use where it is determined after the event that a a piercing tool and one or more of items d, e and f, for example all of items, d, e and f, and optionally items a and/or b and/or c as well would be useful. As such, the user can be provided with all the equipment required to convert a wound dressing 1/300/420 in-situ for use with a pressure gradient wound therapy system.

[0176] In order to use such a kit, the user (e.g. a patient or HCP) can cut an aperture in a dressing 1/30/420, optionally in the region of indica, using the piercing tool 20; attach a port 307 thereto, around the aperture, and in fluid communication therewith; attach one end of the tubing 440 to the port 307 and the other to the pump 410 and run the pump 440 to provide non-atmospheric (e.g. negative) pressure to the wound.

[0177] 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.

[0178] 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.”

[0179] 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.

[0180] 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.